Things we are aware of and understand.
It is possible that authors did not identify, want to identify, or acknowledge potential limitations or were unaware of what limitations existed. Cumulative complexity is the result of the presence of multiple limitations because of the accumulation and interaction of limitations and their components. Just mentioning a limitation category and not the specific parts that are the limitation(s) is not enough. Authors telling readers of their known research limitations is a caution to discount the findings and conclusions. At what point does the caution for each limitation, its ramifications, and consequences become a warning? When does the piling up of mistakes, bad and missing data, biases, small sample size, lack of generalizability, confounding factors, etc., reach a point when the findings become s uninterpretable and meaningless? “Caution” indicates a level of potential hazard; a warning is more dire and consequential. Authors use the word “caution” not “warning” to describe their conclusions. There is a point when the number of limitations and their cumulative effects surpasses the point where a caution statement is no longer applicable, and a warning statement is required. This is the reason for establishing a limitations risk score.
Limitations put medical research articles at risk. The accumulation of limitations (variables having additional limitation components) are gaps and flaws diluting the probability of validity. There is currently no assessment method for evaluating the effect(s) of limitations on research outcomes other than awareness that there is an effect. Authors make statements warning that their results may not be reliable or generalizable, and need more research and larger numbers. Just because the weight effect of any given limitation is not known, explained, or how it discounts findings does not negate a causation effect on data, its analysis, and conclusions. Limitation variables and the ramifications of their effects have consequences. The relationship is not zero effect and accumulates with each added limitation.
As a result of this research, a limitation index score (LIS) system and assessment tool were developed. This limitation risk assessment tool gives a scores assessment of the relative validity of conclusions in a medical article having limitations. The adoption of the LIS scoring assessment tool for authors, researchers, editors, reviewers, and readers is a step toward understanding the effects of limitations and their causal relationships to findings and conclusions. The objective is cleaner, tighter methodologies, and better data assessment, to achieve more reliable findings. Adjustments to research conclusions in the presence of limitations are necessary. The degree of modification depends on context. The cumulative effect of this burden must be acknowledged by a tangible reduction and questioning of the legitimacy of statements made under these circumstances. The description calculating the LIS score is detailed in Appendix 1 .
A limitation word or phrase is not one limitation; it is a group of limitations under the heading of that word or phrase having many additional possible components just as an individual named influence. For instance, when an admission of selection bias is noted, the authors do not explain if it was an exclusion criterion, self-selection, nonresponsiveness, lost to follow-up, recruitment error, how it affects external validity, lack of randomization, etc., or any of the least 263 types of known biases causing systematic distortions of the truth whether unintentional or wanton. 40 , 76 Which forms of selection bias are they identifying? 63 Limitations have branches that introduce additional limitations influencing the study’s ability to reach a useful conclusion. Authors rarely tell you the effect consequences and extent limitations have on their study, findings, and conclusions.
This is a sample of limitations and a few of their component variables under the rubric of a single word or phrase. See Table 3 .
A Limitation Word or Phrase is a Limitation Having Additional Components That Are Additional Limitations. When an Author Uses the Limitation Composite Word or Phrase, They Leave out Which One of Its Components is Contributory to the Research Limitations. Each Limitation Interacts with Other Limitations, Creating a Cluster of Cross Complexities of Data, Findings, and Conclusions That Are Tainted and Negatively Affect Findings and Conclusions
Small Sample Size | Retrospective Study | Selection Bias |
---|---|---|
Low statistical power | Missing information | Affects internal validity |
Estimates not reliable | Recall bias | Nonrandom selection |
Prone to biased samples | Observer bias | Leads to confounding |
Not generalizable | Misclassification bias | Not generalizable |
Prone to false negative error | Observer bias | Inaccurate relation to variables |
Prone to false positive error | Evidence less robust than prospective study | Observer bias |
Sampling error | Missing data | Sampling bias |
Confounding factors | Volunteer bias | |
Selection bias | Survivorship bias |
Limitations rarely occur alone. If you see one there are many you do not see or appreciate. Limitation s components interact with their own and other limitations, leading to complex connections interacting and discounting the reliability of findings. By how much is context dependent: but it is not zero. Limitations are variables influencing outcomes. As the number of limitations increases, the reliability of the conclusions decreases. How many variables (limitations) does it take to nullify the claims of the findings? The weight and influence of each limitation, its aggregate components, and interconnectedness have an unknown magnitude and effect. The result is a disorderly concoction of hearsay explanations. Table 4 is an example of just two single explanation limitations and some of their components illustrating the complex compounding of their effects on each other.
An Example of Interactions between Only Two Limitations and Some of Their Components Causes 16 Interactions
Retrospective Study | Small Sample Size |
---|---|
The novelty of this paper on limitations in medical science is not the identification of research article limitations or their number or frequency; it is the recognition of the multiplier effect(s) limitations and the influence they have on diminishing any conclusion(s) the paper makes. It is possible that limitations contribute to the inability of studies to replicate and why so many are one-time occurrences. Therefore, the generalizability statement that should be given to all readers is BEWARE THERE IS A REDUCTION EFFECT ON THE CONCLUSIONS IN THIS ARTICLE BECAUSE OF ITS LIMITATIONS.
Journals accept studies done with too many limitations, creating forking path situations resulting in an enormous number of possible associations of individual data points as multiple comparisons. 79 The result is confusion, a muddled mess caused by interactions of limitations undermining the ability to make valid inferences. Authors know and acknowledge but rarely explain them or their influence. They also use incomplete and biased databases, biased methods, small sample sizes, and not eliminating confounders, etc., but persist in doing research with these circumstances. Why is that? Is it because when limitations are acknowledged, authors feel justified in their conclusions? It wasn’t my poor research design; it was the limitation(s). How do peer reviewers score and analyze these papers without a method to discount the findings and conclusions in the presence of limitations? What are the calculus editors use to justify papers with multiple limitations, reaching compromised or spurious conclusions? How much caution or warning should a journal say must be taken in interpreting article results? How much? Which results? When? Under what circumstance(s)?
Since a critical component of research is its limitations, the quality and rigor of research are largely defined by, 75 these constraints making it imperative that limitations be exposed and explained. All studies have limitations admitted to or not, and these limitations influence outcomes and conclusions. Unfortunately, they are given insufficient attention, accompanied by feeble excuses, but they all matter. The degrees of freedom of each limitation influence every other limitation, magnifying their ramifications and confusion. Limitations of a scientific article must put the findings in context so the reader can judge the validity and strength of the conclusions. While authors acknowledge the limitations of their study, they influence its legitimacy.
Not only are limitations not properly acknowledged in the scientific literature, 8 but their implications, magnitude, and how they affect a conclusion are not explained or appreciated. Authors work at claiming their work and methods “overcome,” “avoid,” or “circumvent” limitations. Limitations are explained away as “Failure to prove a difference does not prove lack of a difference.” 60 Sample size, bias, confounders, bad data, etc. are not what they seem and do not sully the results. The implication is “trust me.” But that’s not science. Limitations create cognitive distortions and framing (misperception of reality) for the authors and readers. Data in studies with limitations is data having limitations. It was real but tainted.
Limitations are not a trivial aspect of research. It is a tangible something, positive or negative, put into a data set to be analyzed and used to reach a conclusion. How did these extra somethings, known unknowns, not knowns, and unknown knowns, affect the validity of the data set and conclusions? Research presented with the vagaries of explicit limitations is intensified by additional limitations and their component effects on top of the first limitation s , quickly diluting any conclusion making its dependability questionable.
This study’s analysis of limitations in medical articles averaged 3.9% per article for JSLS and 7.4% for Surg Endosc . Authors admit to some and are aware of limitations, but not all of them and discount or leave out others. Limitations were often presented with misleading and hedging language. Authors do not give weight or suggest the percent discount limitations have on the reliance of conclusion(s). Since limitations influence findings, reliability, generalizability, and validity without knowing the magnitude of each and their context, the best that can be said about the conclusions is that they are specific to the study described, context-driven, and suspect.
Limitations mean something is missing, added, incorrect, unseen, unaware of, fabricated, or unknown; circumstances that confuse, confound, and compromise findings and information to the extent that a notice is necessary. All medical articles should have this statement, “Any conclusion drawn from this medical study should be interpreted considering its limitations. Readers should exercise caution, use critical judgement, and consult other sources before accepting these findings. Findings may not be generalizable regardless of sample size, composition, representative data points, and subject groups. Methodologic, analytic, and data collection may have introduced biases or limitations that can affect the accuracy of the results. Controlling for confounding variables, known and unknown, may have influenced the data and/or observations. The accuracy and completeness of the data used to draw a conclusion may not be reliable. The study was specific to time, place, persons, and prevailing circumstances. The weight of each of these factors is unknown to us. Their effect may be limited or compounded and diminish the validity of the proposed conclusions.”
This study and findings are limited and constrained by the limitations of the articles reviewed. They have known and unknown limitations not accounted for, missing data, small sample size, incongruous populations, internal and external validity concerns, confounders, and more. See Tables 2 and and 3 . 3 . Some of these are correctible by the author’s awareness of the consequences of limitations, making plans to address them in the methodology phase of hypothesis assessment and performance of the research to diminish their effects.
Limitations in research articles are expected, but they can be reduced in their effect so that conclusions are closer to being valid. Limitations introduce elements of ignorance and suspicion. They need to be explained so their influence on the believability of the study and its conclusions is closer to meeting construct, content, face, and criterion validity. As the number of limitations increases, common sense, skepticism, study component acceptability, and understanding the ramifications of each limitation are necessary to accept, discount, or reject the author’s findings. As the number of hedging and weasel words used to explain conclusion(s) increases, believability decreases, and raises suspicion regarding claims. Establishing a systematic limitation scoring index limitations for authors, editors, reviewers, and readers and recognizing their cumulative effects will result in a clearer understanding of research content and legitimacy.
How to calculate the Limitation Index Score (LIS). See Tables 5 – 5 . Each limitation admitted to by authors in the article equals (=) one (1) point. Limitations may be generally stated by the author as a broad category, but can have multiple components, such as a retrospective study with these limitation components: 1. data or recall not accurate, 2. data missing, 3. selection bias not controlled, 4. confounders not controlled, 5. no randomization, 6. no blinding, 7. difficult to establish cause and effect, and 8. cannot draw a conclusion of causation. For each component, no matter how many are not explained and corrected, add an additional one (1) point to the score. See Table 2 .
The Limitation Scoring Index is a Numeric Limitation Risk Assessment Score to Rank Risk Categories and Discounting Probability of Validity and Conclusions. The More Limitations in a Study, the Greater the Risk of Unreliable Findings and Conclusions
Number of limitations | Word description of discounting | Proposed percent discounting of conclusions | Outcome probability | Increasing level of less reliable conclusions |
---|---|---|---|---|
0 | Unknown unknowns | 1–10% | May have valid conclusion(s) | Warning |
1–2 | Some | 15–25% | ↓ | ↓ |
3–4 | Probable | 35–45% | ↓ | Caution |
5–6 | Likely | 70–80% | ↓ | ↓ |
7–8 | Highly likely | 85–95% | ↓ | ↓ |
>8 | Certain | 97–100% | Very questionable conclusion(s) | Danger |
Limitations May Be Generally Stated by the Author but Have Multiple Components, Such as a Retrospective Study Having Disadvantage Components of 1. Data or Recall Not Accurate, 2. Data Missing, 3. Selection Bias Not Controlled, 4. Confounders Not Controlled, 5. No Randomization, 6. No Blinding, 7 Difficult to Establish Cause and Effect, 8. Results Are Hypothesis Generating, and 9. Cannot Draw a Conclusion of Causation. For Each Component, Not Explained and Corrected, Add an Additional One (1) Point Is Added to the Score. Extra Blanks Are for Additional Limitations
One point for each limitation | |
---|---|
One additional point for each component of each limitation | |
Retrospective study | |
Small sample size | |
Not generalizable | |
Selection bias | |
Not controlling for confounders | |
Not controlling for comorbidities | |
Incomplete or missing data | |
No long-term follow-up | |
Reporting errors | |
Measurement problems | |
Study design problems | |
Lack of standardized treatment | |
Subtotal for Table 2 |
An Automatic 2 Points is Added for Meta-Analysis Studies Since They Have All the Retrospective Detrimental Components. 44 Data from Insurance, State, National, Medicare, and Medicaid, Because of Incorrect Coding, Over Reporting, and Under-Reporting, Etc. Each Component of the Limitation Adds One Additional Point. For Surveys and Questionnaires Add One Additional Point for Each Bias. Extra Blanks Are for Additional Limitations
Two points for these limitations | |
---|---|
One additional point for each limitation and one additional point for each limitation component. | |
Meta-analysis | |
Data from Medicare, Medicaid, insurance companies, disease, state, and national databases | |
Surveys and questionnaires | |
Each limitation not admitted to | |
Subtotal for Table 3 |
Automatic Five (5) Points for Manufacturer and User Facility Device Experience (MAUDE) Database Articles. The FDA Access Data Site Says Submissions Can Be “Incomplete, Inaccurate, Untimely, Unverified, or Biased” and “the Incidence or Prevalence of an Event Cannot Be Determined from This Reporting System Alone Due to Under-Reporting of Events, Inaccuracies in Reports, Lack of Verification That the Device Caused the Reported Event, and Lack of Information” and “DR Data Alone Cannot Be Used to Establish Rates of Events, Evaluate a Change in Event Rates over Time or Compare Event Rates between Devices. The Number of Reports Cannot Be Interpreted or Used in Isolation to Reach Conclusions” 80
Five points for MAUDE based articles | |
---|---|
One additional point for each additional limitation and one point for each of its components. | |
Subtotal for Table 4 |
Total Limitation Index Score
Limitations | Calculation |
---|---|
Subtotal for Table 2 | |
Subtotal for Table 3 | |
Subtotal for Table 4 | |
Total Limitation Index Score |
Each limitation not admitted to = two (2) points. A meta-analysis study gets an automatic 2 points since they are retrospective and have detrimental components that should be added to the 2 points. Data from insurance, state, national, Medicare, and Medicaid, because of incorrect coding, over-reporting, and underreporting, etc., score 2 points, and each component adds one additional point. Surveys and questionnaires get 2 points, and add one additional point for each bias. See Table 3 .
Manufacturer and User Facility Device Experience (MAUDE) database articles receive an automatic five (5) points. The FDA access data site says, submissions can be “incomplete, inaccurate, untimely, unverified, or biased” and “the incidence or prevalence of an event cannot be determined from this reporting system alone due to underreporting of events, inaccuracies in reports, lack of verification that the device caused the reported event, and lack of information” and “MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions.” 80 See Table 4 . Add one additional point for each additional limitation noted in the article.
Add one additional point for each additional limitation and one point for each of its components. Extra blanks are for additional
limitations and their component scores.
Funding sources: none.
Disclosure: none.
Conflict of interests: none.
Acknowledgments: Author would like to thank Lynda Davis for her help with data collection.
All references have been archived at https://archive.org/web/
Learn about the potential limitations in research and how to appropriately address them in order to deliver honest and ethical research.
It is fairly uncommon for researchers to stumble into the term research limitations when working on their research paper. Limitations in research can arise owing to constraints on design, methods, materials, and so on, and these aspects, unfortunately, may have an influence on your subject’s findings.
In this Mind The Graph’s article, we’ll discuss some recommendations for writing limitations in research , provide examples of various common types of limitations, and suggest how to properly present this information.
The limitations in research are the constraints in design, methods or even researchers’ limitations that affect and influence the interpretation of your research’s ultimate findings. These are limitations on the generalization and usability of findings that emerge from the design of the research and/or the method employed to ensure validity both internally and externally.
Researchers are usually cautious to acknowledge the limitations of their research in their publications for fear of undermining the research’s scientific validity. No research is faultless or covers every possible angle. As a result, addressing the constraints of your research exhibits honesty and integrity .
Though limitations tackle potential flaws in research, commenting on them at the conclusion of your paper, by demonstrating that you are aware of these limitations and explaining how they impact the conclusions that may be taken from the research, improves your research by disclosing any issues before other researchers or reviewers do .
Additionally, emphasizing research constraints implies that you have thoroughly investigated the ramifications of research shortcomings and have a thorough understanding of your research problem.
Limits exist in any research; being honest about them and explaining them would impress researchers and reviewers more than disregarding them.
Remember that acknowledging a research’s shortcomings offers a chance to provide ideas for future research, but be careful to describe how your study may help to concentrate on these outstanding problems.
Here are some limitations connected to methodology and the research procedure that you may need to explain and discuss in connection to your findings.
Sample size.
The number of units of analysis used in your study is determined by the sort of research issue being investigated. It is important to note that if your sample is too small, finding significant connections in the data will be challenging, as statistical tests typically require a larger sample size to ensure a fair representation and this can be limiting.
A lack of data or trustworthy data will almost certainly necessitate limiting the scope of your research or the size of your sample, or it can be a substantial impediment to identifying a pattern and a relevant connection.
Citing previous research papers forms the basis of your literature review and aids in comprehending the research subject you are researching. Yet there may be little if any, past research on your issue.
After finishing your analysis of the findings, you realize that the method you used to collect data limited your capacity to undertake a comprehensive evaluation of the findings. Recognize the flaw by mentioning that future researchers should change the specific approach for data collection.
Sampling inaccuracies arise when a probability sampling method is employed to choose a sample, but that sample does not accurately represent the overall population or the relevant group. As a result, your study suffers from “sampling bias” or “selection bias.”
When your research requires polling certain persons or a specific group, you may have encountered the issue of limited access to these interviewees. Because of the limited access, you may need to reorganize or rearrange your research. In this scenario, explain why access is restricted and ensure that your findings are still trustworthy and valid despite the constraint.
Practical difficulties may limit the amount of time available to explore a research issue and monitor changes as they occur. If time restrictions have any detrimental influence on your research, recognize this impact by expressing the necessity for a future investigation.
Due to their cultural origins or opinions on observed events, researchers may carry biased opinions, which can influence the credibility of a research. Furthermore, researchers may exhibit biases toward data and conclusions that only support their hypotheses or arguments.
The limitations of your research are usually stated at the beginning of the discussion section of your paper so that the reader is aware of and comprehends the limitations prior to actually reading the rest of your findings, or they are stated at the end of the discussion section as an acknowledgment of the need for further research.
The ideal way is to divide your limitations section into three steps:
1. Identify the research constraints;
2. Describe in great detail how they affect your research;
3. Mention the opportunity for future investigations and give possibilities.
By following this method while addressing the constraints of your research, you will be able to effectively highlight your research’s shortcomings without jeopardizing the quality and integrity of your research.
If you want your readers to be engaged and participate in your research, try Mind The Graph tool to add visual assets to your content. Infographics may improve comprehension and are easy to read, just as the Mind The Graph tool is simple to use and offers a variety of templates from which you can select the one that best suits your information.
Exclusive high quality content about effective visual communication in science.
Sign Up for Free
Try the best infographic maker and promote your research with scientifically-accurate beautiful figures
no credit card required
Jessica Abbadia is a lawyer that has been working in Digital Marketing since 2020, improving organic performance for apps and websites in various regions through ASO and SEO. Currently developing scientific and intellectual knowledge for the community's benefit. Jessica is an animal rights activist who enjoys reading and drinking strong coffee.
An official website of the United States government
The .gov means it’s official. Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.
The site is secure. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.
Email citation, add to collections.
Your saved search, create a file for external citation management software, your rss feed.
Affiliations.
Study limitations represent weaknesses within a research design that may influence outcomes and conclusions of the research. Researchers have an obligation to the academic community to present complete and honest limitations of a presented study. Too often, authors use generic descriptions to describe study limitations. Including redundant or irrelevant limitations is an ineffective use of the already limited word count. A meaningful presentation of study limitations should describe the potential limitation, explain the implication of the limitation, provide possible alternative approaches, and describe steps taken to mitigate the limitation. This includes placing research findings within their proper context to ensure readers do not overemphasize or minimize findings. A more complete presentation will enrich the readers' understanding of the study's limitations and support future investigation.
Keywords: Limitations; Research.
PubMed Disclaimer
Full text sources.
NCBI Literature Resources
MeSH PMC Bookshelf Disclaimer
The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). Unauthorized use of these marks is strictly prohibited.
It is for sure that your research will have some limitations and it is normal. However, it is critically important for you to be striving to minimize the range of scope of limitations throughout the research process. Also, you need to provide the acknowledgement of your research limitations in conclusions chapter honestly.
It is always better to identify and acknowledge shortcomings of your work, rather than to leave them pointed out to your by your dissertation assessor. While discussing your research limitations, don’t just provide the list and description of shortcomings of your work. It is also important for you to explain how these limitations have impacted your research findings.
Your research may have multiple limitations, but you need to discuss only those limitations that directly relate to your research problems. For example, if conducting a meta-analysis of the secondary data has not been stated as your research objective, no need to mention it as your research limitation.
Research limitations in a typical dissertation may relate to the following points:
1. Formulation of research aims and objectives . You might have formulated research aims and objectives too broadly. You can specify in which ways the formulation of research aims and objectives could be narrowed so that the level of focus of the study could be increased.
2. Implementation of data collection method . Because you do not have an extensive experience in primary data collection (otherwise you would not be reading this book), there is a great chance that the nature of implementation of data collection method is flawed.
3. Sample size. Sample size depends on the nature of the research problem. If sample size is too small, statistical tests would not be able to identify significant relationships within data set. You can state that basing your study in larger sample size could have generated more accurate results. The importance of sample size is greater in quantitative studies compared to qualitative studies.
4. Lack of previous studies in the research area . Literature review is an important part of any research, because it helps to identify the scope of works that have been done so far in research area. Literature review findings are used as the foundation for the researcher to be built upon to achieve her research objectives.
However, there may be little, if any, prior research on your topic if you have focused on the most contemporary and evolving research problem or too narrow research problem. For example, if you have chosen to explore the role of Bitcoins as the future currency, you may not be able to find tons of scholarly paper addressing the research problem, because Bitcoins are only a recent phenomenon.
5. Scope of discussions . You can include this point as a limitation of your research regardless of the choice of the research area. Because (most likely) you don’t have many years of experience of conducing researches and producing academic papers of such a large size individually, the scope and depth of discussions in your paper is compromised in many levels compared to the works of experienced scholars.
You can discuss certain points from your research limitations as the suggestion for further research at conclusions chapter of your dissertation.
My e-book, The Ultimate Guide to Writing a Dissertation in Business Studies: a step by step assistance offers practical assistance to complete a dissertation with minimum or no stress. The e-book covers all stages of writing a dissertation starting from the selection to the research area to submitting the completed version of the work within the deadline. John Dudovskiy
Enjoy a completely custom, expertly-written dissertation. Choose from hundreds of writers, all of whom are career specialists in your subject.
Research limitations make most studies imperfect. At its core, the research aims to investigate a specific question or questions about a topic. However, some things can hinder your ability to investigate the question or questions extensively. While this can make achieving your goals challenging, it enables you to point areas that require further studies.
That’s why you should demonstrate how future studies can provide answers to your unanswered questions if you encounter study limitations that affect your findings. Presenting the limitations of a study properly shows the readers that you understand your research problem.
After presenting your research findings, your assessment committee wants to see that you did your work professionally. And presenting limitations in a study shows that you carefully thought about your study problem and performed a review of the available literature while analyzing your preferred methods.
Well, limitations mean anything that might affect the generalizability or reliability of the outcomes of an experiment or a study. And this can relate to research design, like your approach or methods. It can also be something to do with how you carried out your research, like running out of resources or time before completing the study.
Either way, students should include their limitations when writing up their studies. In most cases, researchers include limitations in their analysis and discussions. But different schools can provide varying guidelines on how to include limitations in a research paper. Therefore, seek advice from your educator or check your writing style guide to know where to include the limitations of a study when writing a dissertation.
Each study can have unique limitations. However, most students encounter common study limitations when writing academic papers. Here are some of the most common limitations you’re likely to encounter when writing your academic papers.
Sample profile or size: Most researchers encounter sampling as a limitation for their studies. That’s because they have difficulties finding the right sample with the necessary characteristics and size parameters. And this hinders the generalizability of their study results. Also, different sampling techniques are prone to bias and errors. And this can influence the study outcomes. In some cases, researchers have difficulties selecting their samples and opt to pick their participants selectively. Some researchers can even include irrelevant subjects in their general pool to hit their preferred sample size. Availability of previous research or information: Theoretical concepts or previous knowledge form the basis of studies on specific topics. And this provides a sound foundation on which a researcher can develop a research problem for their investigation and a design. However, a topic can be relatively specific or very progressive. In that case, the lack of or inadequate knowledge and previous studies can limit the analysis scope. And this can cause inaccuracies in the arguments or present a significant error margin in several methodologies and research aspects. Methodology errors: Modern research complexity can cause potential methodology limitations. In most cases, these research limitations relate to how the researchers collect and analyze data. That’s because these aspects can influence the outcomes of a study. Researchers use different techniques to gather data. While these techniques may suit a study design, they can present limitations in terms of inappropriate detail levels, distractions, and privacy. Bias: Bias is a potential limitation whose effects can influence the outcome of every study. However, a researcher can avoid this limitation by eliminating prejudiced or emotional attitudes towards their topic and conflict of interest. Researchers should also establish an oversight level by referring to peer-review procedures or an ethics committee. Bias is an inherent trait for human beings. Even the most objective people exhibit a bias to some extent. Nevertheless, a researcher should remain objective while trying to control potential inaccuracies or bias during the research process.
A researcher may not have control over the limitation of study. However, the limitation can be the condition, influence, or shortcoming that places restrictions on their conclusions or methodology. Therefore, researchers should mention all limitations that can influence their results.
The purpose of most studies is to confirm or establish facts, reaffirm a previous study’s outcomes, solve current or new issues, develop a new theory, or support theorems. Research should also enable experts to develop knowledge on specific subjects. And people research different subjects, depending on their interests. However, researchers experience limitations of quantitative research and qualitative research. Here are the most common limitations in research.
Lack or inadequate interactions: Researchers might lack adequate interactions with government institutions and businesses. Consequently, they do not tap a substantial data amount. Researchers should arrange interaction programs with other establishments. That way, they can identify issues that warrant investigation and the necessary data for conducting research, as well as, the benefits of their studies. Overlapping studies can lead fritter resources away or duplicate the findings. Appropriate revision and compilation at regular intervals can solve this problem. Costly publishing: After researching a topic, a researcher should find ways to publish their findings. However, international journals cost a lot of money to publish a study. And this can discourage a researcher from publishing their work. For instance, a study involving females only or carried out in a specific town can have limitations like sample size, gender, and location. What’s more, the entire study could be limited to the researcher’s perception. Lack of or inadequate training: The research process doesn’t have a systematic methodology. Many researchers do not understand the research method when carrying out their work. Consequently, most researchers experience methodological limitations. Essentially, most researchers replicate the methodologies of similar studies. Even some research guides don’t explain the methodologies accurately. And this can limit the outcome of some studies. Lack of code of conduct: Researchers don’t have a code of conduct. And this causes inter-university and inter-departmental rivalries. Library functioning and management are not adequate in most places. Consequently, some researchers spend a lot of energy and time tracing the necessary books, reports, and journals for their studies. Such energy and time can be spent tracing relevant materials. Lack of confidence: The lack of confidence is among the most common limitations of research studies because company managers think that a researcher can misuse the data they disclose to them. Consequently, they don’t want to reveal their business information. And this can affect studies, yet data from researchers can help the same institutions. Therefore, organizations and researchers should implement confidence-building strategies to encourage companies to share data, knowing that researchers will use it productively.
When writing a research paper or a thesis, some people think including study limitations is counterintuitive. That’s particularly the case for researchers that experienced something wrong. However, mentioning the limitations of your study is imperative for the following reasons.
Most professors spot problems with the students’ work even if they don’t mention them. Consequently, embracing the limitations of your study and including them in your analysis is the best approach. Leaving out the limitations of research or vital aspects of a study can be detrimental to the entire study field. That’s because it can establish a potentially fallacious and incomplete depiction of the study.
In the academic world, players expect researchers to include the limitations of their works. And this includes a section that demonstrates a holistic and comprehensive understanding of a topic and research process by the author. Discussing limitations is a learning process for assessing the magnitude while critically evaluating the extenuating effect of the stated limitations.
Stating the limitations of a study also improves the validity and quality of future studies. And this includes limitations whose basis is the transparency principle in scientific research, whose purpose is to promote further progress while maintaining mutual integrity in similar studies.
When writing your research limitations, do it in a way that demonstrates your understanding of the core concepts of confounding, analytical self-criticism, and bias. Highlighting every limitation might not be necessary. However, include every limitation with a direct impact on your research problem or study results.
Present your thought process as a researcher and explain the pros and cons of your decisions. Also, explain circumstances that may have led to a research limitation. Here’s how you should structure your limitations.
Don’t forget that acknowledging your study limitations provides a chance to suggest the direction for further studies. Therefore, connect the limitations of your study to the suggestions you make for further research. Also, explain how your study can make the unanswered questions more focused.
Also, acknowledging the limitation of the study enables you to demonstrate to the professor that you have critically thought about your research problem and understood the importance of the already-published literature. What’s more, it shows that you’ve carefully assessed the methods for studying your study problem. In research, a key objective is to discover new knowledge while confronting assumptions as you explore what others might not know.
Writing limitations should be a subjective process. That’s because you must analyze the impacts of the limitations and include them in your paper. In this section, don’t include the key weaknesses only. Instead, highlight the magnitude of the limitations of your research. And doing this requires you to demonstrate your study’s validity. Show the readers how the limitations have impacted your study outcomes and conclusions. Thus, writing the limitations section of your paper requires an overall, critical interpretation and appraisal of the impact. Essentially, this section should tell the readers why the problems with methods, errors, validity, and other limitations matter and to what extent.
When writing a research paper, include information about your study’s limitations at the beginning of the discussion section. That way, your readers can understand your study limitations before delving into the deeper analysis. In some cases, authors bring out limitations when concluding their research discussion and highlighting the essence of further study on the subject. Here are practical tips to help you write the limitations of your study more effectively.
When working on the limitations section of a research paper, be precise and clear. If writing this section becomes challenging, follow the tips shared in this article or seek assistance. That way, you can impress your educator by highlighting the limitations of your study properly.
Richard Ginger is a dissertation writer and freelance columnist with a wealth of knowledge and expertise in the writing industry. He handles every project he works on with precision while keeping attention to details and ensuring that every work he does is unique.
Succeed With A Perfect Dissertation
Your email address will not be published. Required fields are marked *
Save my name, email, and website in this browser for the next time I comment.
As Putin continues killing civilians, bombing kindergartens, and threatening WWIII, Ukraine fights for the world's peaceful future.
Ukraine Live Updates
Military Medical Research volume 11 , Article number: 63 ( 2024 ) Cite this article
Metrics details
With advancements in burn treatment and intensive care leading to decreased mortality rates, a growing cohort of burn survivors is emerging. These individuals may be susceptible to frailty, characterized by reduced physiological reserve and increased vulnerability to stressors commonly associated with aging, which significantly complicates their recovery process. To date, no study has investigated burns as a potential risk factor for frailty. This study aimed to determine the short-term prevalence of frailty among burn survivors’ months after injury and compare it with that of the general population.
A post hoc analysis was conducted on the Randomized Trial of Enteral Glutamine to Minimize the Effects of Burn Injury (RE-ENERGIZE) trial, an international randomized-controlled trial involving 1200 burn injury patients with partial- or full-thickness burns. Participants who did not complete the 36-Item Short Form Health Survey (SF-36) questionnaire were excluded. Data for the general population were obtained from the 2022 National Health Interview Survey (NHIS). Frailty was assessed using the FRAIL (Fatigue, Resistance, Ambulation, Illness, Loss of weight) scale. Due to lack of data on loss of weight, for the purposes of this study, malnutrition was used as the fifth variable. Illness and malnutrition were based on admission data, while fatigue, resistance, and ambulation were determined from post-discharge responses to the SF-36. The burn cohort and general population groups were matched using propensity score matching and compared in terms of frailty status. Within the burn group, patients were divided into different subgroups based on their frailty status, and the differences in their (instrumental) activities of daily living (iADL and ADL) were compared. A multivariable analysis was performed within the burn cohort to identify factors predisposing to frailty as well as compromised iADL and ADL.
Out of the 1200 burn patients involved in the study, 600 completed the required questionnaires [follow-up time: (5.5 ± 2.3) months] and were matched to 1200 adults from the general population in the U.S. In comparison to the general population, burn patients exhibited a significantly higher likelihood of being pre-frail (42.3% vs. 19.8%, P < 0.0001), or frail (13.0% vs. 1.0%, P < 0.0001). When focusing on specific components, burn patients were more prone to experiencing fatigue (25.8% vs. 13.5%, P < 0.0001), limited resistance (34.0% vs. 2.7%, P < 0.0001), and restricted ambulation (41.8% vs. 3.8%, P < 0.0001). Conversely, the incidence rate of illness was observed to be higher in the general population (1.2% vs. 2.8%, P = 0.03), while no significant difference was detected regarding malnutrition (2.3% vs. 2.6%, P = 0.75). Furthermore, in comparison with robust burn patients, it was significantly more likely for pre-frail and frail patients to disclose compromise in ADL and iADL. The frail cohort reported the most pronounced limitation.
Our findings suggest a higher incidence of post-discharge frailty among burn survivors in the short-term following injury. Burn survivors experience compromised fatigue, resistance, and ambulation, while rates of illness and malnutrition were lower or unchanged, respectively. These results underscore the critical need for early identification of frailty after a burn injury, with timely and comprehensive involvement of a multidisciplinary team including burn and pain specialists, community physicians, physiotherapists, nutritionists, and social workers. This collaborative effort can ensure holistic care to address and mitigate frailty in this patient population.
It is estimated that up to 33,000 people each day—7 to 12 million people per year—sustain a burn injury that requires medical care and can lead to limitations in quality of life or result in death [ 1 ]. Given the backdrop of an aging population, there has been a burgeoning interest in evaluating post-burn outcomes among older adults. The assessment of the impact of “aging” on post-burn outcomes requires analysis through the lens of frailty, whereby frailty denotes an augmented susceptibility to stressors due to decreased physiological reserve and diminished capacity to maintain homeostasis [ 2 ].
A systematic review conducted in 2023 synthesized all published research on frailty and burns, identifying 18 studies dating back to 2013, with one-third of the studies published in 2022 [ 3 ]. All studies explored frailty as a risk factor for adverse outcomes of acute burns, yet the reverse hypothesis—that burn injury itself is a risk factor for long-term frailty—remains entirely unexplored. This gap in research is significant, considering that the long-term consequences of burns align with the criteria of most frailty indices [ 4 , 5 , 6 , 7 , 8 , 9 , 10 , 11 ]. Despite this, a history of burns is not included in such assessments.
The hypothesis proposed here is that individuals with a history of burns may exhibit a higher prevalence of frailty compared to the general population, and these differences become apparent a few months post-discharge, which is typically when burn survivors are reintegrating into their normal lives. By highlighting the severity of this issue and outlining its impact on quality of life, we aim to identify potential opportunities and pathways for informing clinical practice, future research, and policymaking efforts.
The burn population was identified from the previously published Randomized Trial of Enteral Glutamine to Minimize the Effects of Burn Injury (RE-ENERGIZE). RE-ENERGIZE was an international, multicenter, double-blinded, randomized-controlled trial that investigated the effects of enteral glutamine supplementation (0.5 g/kg) in severe burn patients. Severe burns were defined as those of partial- or full-thickness that would necessitate surgery [ 12 ]. The data collection period for RE-ENERGIZE spanned 10 years (2011–2021), and the findings were published by Heyland et al. [ 12 ] in 2022. In summary, a total of 1209 patients from 54 burn units across 14 countries were enrolled. The eligible total body surface area (TBSA) burned criteria was: > 20% for individuals aged 18 to 39 years, > 15% within concomitant inhalation injury, > 15% for individuals aged 40 to 59 years, and > 10% for those over age 60. Therefore, patients admitted with severe burns covering an average TBSA burn of 33% underwent randomization. A total of 1200 individuals were included in the final analysis, of which 596 belonged to the glutamine group while 604 were in the placebo group. Since no beneficial effect was observed from glutamine in the original trial, both groups were combined for our burn cohort analysis. The relevant data collected encompassed details about burn centers (such as geographic regions), patient demographics [including sex, age, race/ethnicity, body mass index (BMI), substance use like alcohol or smoking], and injury specifics [such as cause and extent of burn (TBSA)], as well as outcomes [comprising length of stay in the intensive care unit (ICU), length of hospital stay (LOHS), and discharge destination].
The 2022 National Health Interview Survey (NHIS) served as the primary data source for the general population. Administered by the National Center for Health Statistics through telephone or face-to-face (household) interviews, NHIS collects annual cross-sectional data on the health status of the U.S. population. The dataset employs a multistage probability study design to ensure that the data are representative of both household and non-institutionalized civilian populations in the U.S. Additionally, there is an oversampling of Black, Asian, and Hispanic populations [ 13 ]. Eligible participants include residents living in households or non-institutional settings, including rooming houses, group homes, and homeless shelters.
This study is a post hoc analysis of the RE-ENERGIZE (NCT00985205) trial, in which the analyzed data of the burn cohort have been previously published [ 12 ]. The complete dataset is not publicly accessible due to its inclusion of sensitive information that could potentially compromise the privacy of research participants. The RE-ENERGIZE trial protocol was approved by the Research Ethics Committees at Queen’s University, Kingston, Ontario, Canada (Approval No. NCT00985205; https://clinicaltrials.gov/study/NCT00985205 ), and all participating centers and the informed consent form underwent review and approved by the Research Ethics Board (REB approval NO. 6013407). Before randomization, each patient or their designated surrogate provided written informed consent. All documentation regarding the ethical approval can be found in the published protocol [ 14 ]. Data concerning the normative population are openly accessible from the Centers for Disease Control and Prevention National Health Center for Health Statistics at https://www.cdc.gov/nchs/nhis/data-questionnaires-documentation.htm , 2022 NHIS document.
The FRAIL scale consists of 5 components: fatigue, resistance, ambulation, illness, and loss of weight [ 15 ]. This is a widely used and extensively studied tool with previous research supporting its validity in frailty assessment in various populations, although not specifically in a burn injury cohort [ 16 , 17 , 18 , 19 , 20 ]. On average, 3 to 6 months after hospital discharge, the patients were contacted to complete the 36-Item Short Form Health Survey (SF-36) questionnaire. Fatigue, resistance, and ambulation were determined from responses to the SF-36 or NHIS questionnaires and are indicative of the post-discharge status. Illness indicated the presence of more than 5 of the following conditions: hypertension, diabetes, cancer other than minor skin cancer, chronic lung disease, myocardial infarction, congestive heart failure or coronary artery disease, angina, asthma, arthritis, and stroke. Kidney disease was excluded from the analysis because of missing data in the NHIS. Due to insufficient data in both burn injury and control cohorts, the concept of “loss of weight” was substituted with “malnutrition”, using recognized definitions from the World Health Organization and the European Society for Clinical Nutrition and Metabolism [ 21 ]. Therefore, in terms of time point, the onset of illness and loss of weight occurred at the time of hospital admission, while fatigue, resistance, and ambulation were assessed at 3–6 months after hospital discharge. A score of 0 on the FRAIL scale indicates robustness, a score of 1–2 indicates pre-frailty, and a score of 3–5 indicates frailty. Figure 1 provides an overview of the questions and scoring methodology [ 21 ]. The relationship between TBSA and frailty was investigated by comparing the distribution of TBSA among three groups: robustness ( n = 268), pre-frailty ( n = 254), and frailty ( n = 78).
Components of the FRAIL scale. FRAIL scale is an acronym for fatigue, resistance, ambulation, illness, and loss of weight. Respondents were asked to report their level of tiredness over the past 4 weeks. Those who felt “all of the time” or “most of the time” scored 1 point on the fatigue component. Similarly, respondents were asked to query about any difficulty walking up 10 steps alone without resting or aids. Those answering “Yes” scored 1 point on the resistance component. Additionally, respondents were asked if they had any difficulty walking several hundred yards alone without aids. A positive response also scored 1 point on the ambulation component. Finally, individuals reporting 5 or more out of 11 specified illnesses (hypertension, diabetes, cancer other than minor skin cancer, COPD/chronic lung disease, myocardial infarction, congestive heart failure or coronary artery disease, angina, asthma, arthritis, stroke, and kidney disease), scored 1 point on the illness component. Kidney disease is excluded because of missing data in the NHIS. Due to insufficient data on weight change in both the Randomized Trial of Enteral Glutamine to Minimize the Effects of Burn Injury (RE-ENERGIZE) and National Health Interview Survey (NHIS) cohorts, loss of weight was replaced by malnutrition. Using accepted definitions of malnutrition from the World Health Organization and the European Society for Clinical Nutrition and Metabolism [ 21 ], individuals with a body mass index (BMI) lower than 18.5 kg/m 2 , those aged between 65–70 years with BMI < 20 kg/m 2 , and those aged over 70 years with BMI < 22 kg/m 2 were assigned a score of 1 point on the malnutrition component. Finally, each component on the FRAIL scale contributes 1 point to overall scores ranging from 0–5, where a score of 0 indicates robustness, while scores between 1–2 indicate pre-frailty and scores between 3–5 indicate frailty
The post-discharge independence of burn patients was evaluated through the assessment of their responses to the Katz index of activities of daily living (ADL) [ 22 ] and the Lawton index of instrumental activities of daily living (iADL) [ 23 ] questionnaires, as previously described [ 19 ]. ADL and iADL are two commonly assessed domains on self-reported questionnaires for measuring functional disability [ 24 ], both considered significant predictors of long-term care service use [ 25 ]. ADL includes 4 components (toileting, transferring, continence, and feeding), while iADL comprises 8 components (ability to use a telephone, shopping, food preparation, housekeeping, laundry, mode of transportation, responsibility for own medications, and ability to handle finances). Any response indicating less than complete independence was classified as an ADL limitation. The utilization of both the Katz index for assessing ADL independence and the Lawton index for evaluating iADL has been prevalent in prior research due to its comprehensive insight into an individual’s functional abilities [ 26 , 27 , 28 , 29 , 30 , 31 ]. While, ADL to self-care tasks essential for basic survival and well-being, such as toileting, bathing, eating, and dressing, iADL involves more complex tasks supporting daily life within the home and community. Examples include tasks such as household management, financial administration, telephone usage, grocery procurement, and medication compliance [ 32 ]. The combined iADL and ADL scores were calculated and plotted against the follow-up period. For example, when computing the iADL score, each component was assigned a point score which was then summed to yield an overall score. For instance, the component “Ability to use the telephone” was scored as follows: “Operates telephone on own initiative, looks up and dials numbers” scored 0, “Dials a few well-known numbers” scored 1, “Answers telephone, but does not dial” scored 2, and “Does not use the phone at all” scored 3. Consequently, higher scores indicate greater dependence. ADL and iADL assessments were conducted 2 to 15 months post-hospital discharge.
All data from both databases were collected and matched in Microsoft Excel ® 2024 (Microsoft, Redmond, WA, USA). Propensity score matching was performed in R software (version 4.1.2) using the Matchlt package. Each treated unit “burn patient” was paired with two controls “general population” through a nearest-neighbor one-to-two matching technique to enhance study precision as previously described [ 33 ]. Matching variables included age, sex, race/ethnicity, BMI, history of alcohol misuse, and current smoking status. The quality of the matching was visualized with histograms and jitter plots (Additional file 1 : Figs. S1, S2). The resulting matched cohorts were subsequently utilized for assessing frailty by comparing all 5 components of the FRAIL scale. Continuous data (age, BMI) were presented as means and standard deviations (SD) and compared using a Student’s t -test, while categorical data were presented as absolute n (%) and compared using a χ 2 or Fishers exact test, as appropriate. Finally, a multivariable linear regression analysis was performed on the burns cohort to identify factors associated with frailty, compromised ADL, and iADL. Included variables were age, alcohol misuse, smoking, type of burn (scald, chemical, other), BMI, TBSA, LOHS, glutamine administration, sex, and race. All statistical analysis was conducted in GraphPad Prism (version 9) and the data were visualized in GraphPad Prism and Adobe Illustrator. All P -values less than 0.05 were considered significant.
In the RE-ENERGIZE trial, there were a total of 1200 participants, of whom 600 completed the necessary questionnaires to meet the eligibility criteria for this post-hoc study. The patient recruitment process is detailed in Fig. 2 . Average follow-up time was (5.5 ± 2.3) months post-burn. A total of 1200 adults from the general population were included matched (Table 1 ). The burn population was well-matched to the general population, with both cohorts consisting predominantly of males (> 70.0%) and individuals of White ethnicity (> 70%). The cohorts were similar in terms of age [(48.7 ± 17.1) years vs. (48.3 ± 17.8) years, P = 0.65] and BMI [(28.3 ± 6.0) kg/m 2 vs. (28.0 ± 7.6) kg/m 2 , P = 0.50]. The burn cohort had a higher percentage of Native American subjects (3.0% vs. 1.0%, P = 0.002), while the normative cohort had a higher percentage of Black or African American subjects (6.3% vs. 10.8%, P = 0.002; Table 1 ).
Patient recruitment process. ADL activities of daily living, iADL instrumental activities of daily living, NHIS National Health Interview Survey
Out of 600 burn patients, there were 268 classified as robustness, while 254 were categorized as pre-frailty, and another 78 as frailty individuals within this cohort group. Additionally, burn patients exhibited a notably lower likelihood of being classified as robustness compared to their counterparts in normative populations (44.7% vs. 79.2%, P < 0.0001), but showed a substantially higher probability of being categorized as pre-frail (42.3% vs. 19.8%, P < 0.0001), or frail individuals (13.0% vs. 1.0%, P < 0.0001; Table 1 ). Furthermore, when examining specific components of the FRAIL scale among these patients with burns, it became evident that they had an increased tendency towards experiencing fatigue (25.8% vs. 13.5%, P < 0.0001), increased resistance (34.0% vs. 2.7%, P < 0.0001), and restricted ambulation (41.8% vs. 3.8%, P < 0.0001). Moreover, the incidence of illness appeared higher in the general population compared to that observed among those with burns (1.2% vs. 2.8%, P = 0.03). However, malnutrition rates did not display significant differences between these two groups (2.3% vs. 2.6%, P = 0.75; Table 1 ). Lastly, an analysis focusing on various comorbidities encompassed within the illness component revealed that individuals from general populations demonstrated a notably greater likelihood of having conditions such as asthma, arthritis, congestive heart failure (CHF) or coronary heart disease (CHD), chronic obstructive pulmonary disease (COPD)/chronic lung disease, hypertension and myocardial infarction ( P < 0.05) whereas those from the burn patient group displayed a markedly elevated probability for cancer other than minor skin cancer and diabetes ( P < 0.01).
When examining the relationship between TBSA and frailty, we observed that the majority of robust patients (score 0) had a TBSA ranging from 20 to 29% (102/268; accounting for 38.1% of all robust patients), followed by a TBSA range of 10 to 19% (60/268; representing 22.4% of all robust patients). The overall TBSA range for robust patients was from 10 to 76%. Similarly, most pre-frail patients (score 1–2) exhibited a TBSA between 20 and 29% (87/254; constituting 34.3% of all pre-frail patients), followed by a TBSA between 30 and 39% (58/254; representing 22.8% of all pre-frail patients). The total TBSA range for pre-frail patients was from 10 to 93%. Finally, the majority of frail patients (score 3–5) had a TBSA between 20 and 29% (24/78; accounting for 30.8% of all frail patients), followed by a TBSA ranging from 10 to 19% (17/78; constituting 21.8% of all frail patients). The total TBSA range for frail patients was from 10 to 85% (Fig. 3 a). When considering the entire cohort, most patients exhibited robust and had a TBSA of 20–29% (102/600; 17.0% of all patients), followed by pre-frail patients with a TBSA of 20–29% (87/600; 14.5% of all patients), and then robust patients with a TBSA of 10–19% (60/600; 10.0% of all patients; Fig. 3 b).
Association between TBSA and frailty. a The distribution of TBSA percentages across frailty score groups indicates that the majority of robust, pre-frail, and frail patients had a TBSA between 20 and 29%. As TBSA increases, there is a corresponding increase in the percentage of pre-frail and frail patients. b The distribution of TBSA among the patient cohort is visualized as a percentage. The majority of patients demonstrated robustness with a TBSA of 20–29% (102/600; 17.0% of all patients), followed by pre-frail patients within the same TBSA range (87/600; 14.5% of all patients)
In comparison to robust burn patients, pre-frail burn patients exhibited a significantly higher likelihood of requiring assistance in toileting (11.4% vs. 2.6%, P < 0.0001), transferring (10.6% vs. 0.7%, P < 0.0001), continence (9.1% vs. 1.1%, P < 0.0001), and feeding (6.7% vs. 1.1%, P < 0.0001). Similarly, frail burn patients were notably more likely than robust patients to necessitate assistance in toileting (30.8% vs. 2.6%, P < 0.0001), transferring (28.2% vs. 0.7%, P < 0.0001), continence (20.5% vs. 1.1%, P < 0.0001), and feeding (17.9% vs. 1.1%, P = 0.001; Table 2 ). The distribution of ADL score over follow-up time is depicted in Additional file 1 : Fig. S3.
Compared to robust patients, pre-frail burn patients demonstrated significantly lower levels of independently in using the telephone (87.0% vs. 95.5%, P = 0.002), shopping (48.4% vs. 81.7%, P < 0.0001), meal preparation (53.9% vs. 81.3%, P < 0.0001), housekeeping (37.0% vs. 72.4%, P < 0.0001), laundry (60.6% vs. 81.3%, P < 0.0001), travel (55.1% vs. 82.1%, P < 0.0001), managing their medication (73.2% vs. 92.9%, P < 0.0001), and financial management (69.3% vs. 88.4%, P < 0.0001; Table 2 ).
In comparison to robust patients, frail burn patients showed significantly lower levels of independence in using the telephone (80.8% vs. 95.5%, P < 0.0001), shopping (21.8% vs. 81.7%, P < 0.0001), preparing meals (26.9% vs. 81.3%, P < 0.0001), housekeeping (14.1% vs. 72.4%, P < 0.0001), laundry (33.3% vs. 81.3%, P < 0.0001), travel (34.6% vs. 82.1%, P < 0.0001), managing their medication (51.3% vs. 92.9%, P < 0.0001), and financial management (48.7% vs. 88.4%, P < 0.0001; Table 2 ). The distribution of iADL score against follow-up time is shown in Additional file 1 : Fig. S3.
The entire burn cohort was utilized to conduct a multivariable linear regression analysis aimed at identifying risk factors for frailty, as well as limitations in ADL and iADL. The results revealed that age ( P < 0.0001) and smoking ( P = 0.04) were independent risk factors for frailty. Furthermore, the chemical burn was identified as an independent risk factor for ADL limitations ( P = 0.0003), while both chemical burn ( P = 0.01) and scald burn ( P = 0.04) were identified as independent risk factors for iADL limitations. Additionally, individuals of Asian or Pacific Islander race were found to have a protective effect against iADL limitations ( P = 0.01, Table 3 ).
Advancements in both burn care and intensive care have led to decreased mortality rates, with reports showing a survival rate of 96.7% among individuals treated at burn centers across the U.S. [ 1 ]. There has been a notable increase in post-burn morbidity within the expanding community of burn survivors [ 34 , 35 ]. Put differently, as these survivors live longer lives, they are increasingly confronted with enduring consequences from their injuries. Frailty, characterized by diminished physiological reserve and increased susceptibility to stressors, can significantly complicate efforts to manage and rehabilitate these individuals (Additional file 1 : Fig. S4) [ 11 , 36 ]. This underscores the necessity for an enhanced comprehension regarding long-term susceptibility to frailty in this patient population. In the discussion, we leverage findings from this study to propose diverse strategies aimed at mitigating and limiting frailty among burn survivors.
Our analysis indicates a higher prevalence of frailty in the burn population, approximately 5 months after injury (Fig. 4 ). The components of fatigue, resistance, and ambulation were all significantly more restricted in the burn survivors, while the variables of frailty assessed on hospital admission, that is, illness and malnutrition, were higher or did not differ in the normative population, respectively. This provides evidence that although the patients were not frail upon admission to the hospital, they experienced a significant increase in frailty shortly after discharge. This emphasizes the importance of early recognition and assessment of frailty following a burn injury as a critical component of comprehensive burn care. Importantly, the RE-ENERGIZE data did not include information on the pre-burn frail status of patients. Therefore, an exact inference about which patients became frail after the injury cannot be made.
Long-term trajectory of frailty among burn patients is influenced by targeted intervention. Following burn injuries in the short term, patients may face compromised resistance and ambulation while concurrently experiencing fatigue stemming from various factors such as inadequate pain management leading to disrupted sleep patterns or heightened anxiety and depression related to trauma-induced sequelae. Collectively impacting patient independence including (instrumental) activities of daily living, these challenges encompass essential tasks, such as shopping and cooking, cleaning and managing medications, as well as finances. In the long run, this could result in malnutrition, an increase in chronic illnesses, and a notable elevation across all 5 components measured by the FRAIL score. Hypothetically, prompt long-standing engagement with a multidisciplinary team comprising rehabilitation services, community physicians, nutritionists, pain and mental health specialists, as well as social support, holds promise for mitigating fatigue, resistance compromises, and averting prolonged illness and malnutrition
Interestingly, our multivariable analysis of predisposing factors did not reveal TBSA to have a significant impact on the development of frailty, while age was a predictable predictor. Although there was a slight trend suggesting that patients with higher TBSA were also more likely to have higher FRAIL scores (Fig. 3 ), the multivariate analysis showed no significant correlation between TBSA and frailty. TBSA is one of the most powerful indicators of burn trauma severity and strongly correlates with adverse outcomes and short- and long-term morbidity [ 37 , 38 ]. This finding highlights the multifactorial nature of frailty in general and certainly emphasizes the need for more advanced screening methods that go beyond mere burn size [ 39 , 40 , 41 ].
The management of severe burn injuries in general, and frailty in severely burned patients in particular, requires a multidisciplinary team approach involving burn specialists, community physicians, geriatricians, pain management experts, physiotherapists, occupational therapists, mental health professionals, nutritionists, and social workers (Fig. 4 ).
The long-term trajectory of burn survivors is characterized by low resistance and low ambulation which limits patients’ independence, predisposing to illness. At the same time increased fatigue and malnutrition also predispose to illness. A multidisciplinary collaborative effort ensures comprehensive care for addressing the diverse needs of frail patients, including rehabilitation to minimize the loss of ambulation and resistance, medical management to promptly identify and treat illnesses such as cardiovascular compromise and diabetes, nutritional support to prevent malnutrition and thus limit illness, and psychosocial interventions [ 42 ]. By maintaining ambulation and resistance, independence is maximized which in turn limits malnutrition, illness and fatigue. For example, occupational therapy can promote well-being through occupation by enabling burn survivors to engage in meaningful activities of everyday life. Occupational therapy achieves this by collaborating with patients and their community to enhance the survivors’ ability to engage in their chosen or necessary occupation or by modifying their occupation or environment to better support their engagement [ 43 ].
We have identified significant limitations in iADL and ADL among frail burn survivors, which compromise their independence and predispose these patients to further frailty. Approximately 25% of frail burn survivors report being unable to dispense their medication, compared to 1% of robust survivors. This notable limitation may have multiple contributing factors (e.g., disability due to a hand burn, presence of compression garments, and the type and shape of medication bottles), presenting a multidisciplinary challenge for resolution. The inability to adhere to medications could result in untreated illness and consequently increase frailty [ 44 , 45 ]. Addressing this issue may require modified medication bottles, adaptive aids promoting independence, as well as specialized situational training through physiotherapy and occupational therapy. Additionally, social support can enhance adherence and overall well-being. The retrospective nature of this post hoc analysis limited our ability to consider certain variables that may influence our results, such as the body location of the burn injury (e.g., extremities or face), depth of the burn (e.g., second or third degree), setting of the injury (e.g., work-related or home-related), post-discharge care options (e.g., inpatient physiotherapy, outpatient physiotherapy or occupational therapy, treatment by mental health or pain specialists), as well as the socioeconomic status of the patients.
Frailty often leads to impaired nutritional status and decreased muscle mass [ 46 , 47 ], which can impede wound healing and functional recovery in burn patients [ 48 , 49 ]. Our multivariable analysis revealed no association between glutamine administration and the extent of frailty, ADL, and iADL. Similarly, previous literature on amino acid supplementation in the treatment of sarcopenia and frailty has yielded conflicting results [ 50 , 51 , 52 ]. Although hydroxyl-methyl butyrate has been reported to enhance muscle protein synthesis when combined with arginine and glutamine, glutamine alone has not been shown to prevent muscle deterioration [ 53 ]. Following a burn injury, the body’s energy and nutrient demand increase dramatically to support tissue repair and wound healing [ 5 ]. During the acute phase, adequate nutrition, including sufficient calories, protein, vitamins, and minerals, is crucial for facilitating the regeneration of damaged tissues, while minimizing complications such as infections, and promoting faster wound closure [ 54 ]. Preventing malnutrition during this high-demand period can reduce the risk of long-term frailty associated with prolonged healing and impaired tissue integrity [ 55 ]. In the medium- and long-term, severe burn injuries result in muscle wasting and loss of lean body mass due to increased protein breakdown and decreased protein synthesis [ 56 ].
In turn, a significant reduction in muscle mass and strength can severely impact the activity and energy levels of burn survivors. They often experience chronic fatigue, decreased stamina, and overall weakness, making it challenging to perform even basic ADLs such as dressing and bathing [ 57 ]. Our findings indicated that frailer burn survivors are more likely to require assistance with feeding, rely on parenteral feeding, and need help with shopping. More than 40% of frail burn survivors required their meals to be prepared and served compared to only 3% of robust survivors. Furthermore, diminished energy and physical capacity compromise the ability to participate in social and recreational activities, further affecting the quality of life [ 58 ]. As a result, survivors may increasingly depend on caregivers or adaptive aids, impacting their sense of independence and self-esteem. Additionally, the combination of physical limitations and increased dependency can contribute to a cycle of reduced physical activity, further exacerbating muscle wasting and frailty. Optimal nutrition, particularly high-quality protein intake, is crucial for preserving muscle mass, strength, and function, which are essential for mobility, independence, and overall resilience against frailty (Additional file 1 : Fig. S4) [ 59 ]. Adequate nutrition is essential for providing the energy required for daily activities, rehabilitation, and physical therapy. It plays a crucial role in maintaining muscle strength, endurance, and functional independence. These factors are fundamental prerequisites for implementing a comprehensive rehabilitation program that includes nutritional support, physical therapy, and occupational therapy to help mitigate these effects [ 58 ]. Such programs aim to restore muscle mass, improve energy levels, and enhance the individual’s ability to participate in ADL, ultimately promoting greater independence and quality of life.
Burn patients are at increased risk of experiencing long-term complications, such as chronic pain, functional impairment, and recurrent hospitalizations, which have been shown to contribute to frailty (Additional file 1 : Fig. S4) [ 8 , 35 , 39 ]. In a recent post hoc analysis of the same burn cohort, our research team identified a strong correlation between chronic pain, anxiety, and depression in these patients [ 60 ]. Previous research has also established a significant link between poor mental health and long-term frailty [ 61 ]. This highlights the necessity for comprehensive care that integrates both mental health support and physical rehabilitation to optimize the long-term outcomes of burn survivors. Establishing structured long-term follow-up programs is essential for monitoring progress, addressing ongoing needs, and preventing future frailty-related events. Losing track of burn patients during follow-up poses a significant concern both clinically and scientifically: comparison of the burn patients who were “lost to follow-up” with those included as responders revealed notable differences in baseline characteristics. Non-responders were on average younger, more likely to be smokers, less likely to be Hispanic but more likely to be African American. They were also more likely to have had inhalation injury or been transferred to another hospital ward with shorter hospital and ICU stays. This inherent limitation present in all prospective research regarding short- and long-term burn survivors emphasizes the importance of standardized 6-month follow-ups that extend beyond evaluating the need for secondary reconstructive procedures.
Although early detection of frailty and ADL deficiencies has been established, little information exists regarding their longitudinal progression. It is essential to collect outcome measures over time [ 62 , 63 ], and implement extended, standardized, and interdisciplinary long-term protocols. A recent meta-analysis found that follow-up for burn patients seldom extends 5 years post-injury, which is considered long term [ 39 ]. Currently, all specialized follow-up care for burn survivors is exclusively provided by surgical institutions involved in secondary reconstruction. After achieving satisfactory reconstruction and reaching an acceptable level of scarring control, pain management effectiveness, and functional capability improvement, patient monitoring becomes sporadic or ceases altogether. There remains a lack of comprehensive protocols for diagnosing and treating long-term organ damage across disciplines while assessing their respective contributions to complex phenomena such as frailty. It is essential to identify long-term complications that may appear unrelated but are linked with an increased risk of developing diabetes and cardiovascular disease over decades. The establishment of a standardized interdisciplinary system for monitoring burn patients in the long term is crucial. This system could involve lifelong, follow-up appointments every 5 years similar to those offered for cancer patients after hospital discharge. To validate our preliminary findings comprehensively and ensure their applicability across different contexts, independent studies or datasets should confirm them. Conducting a prospective study comparing frailty levels upon admission with those at early (within months) and long-term (after years) post-discharge intervals, while examining diverse post-discharge care options like physiotherapy or occupational therapy would significantly enhance our understanding of chronic burn injury effects.
The response data are based on self-reporting, which is inherently susceptible to inaccuracies. Due to differences in the questionnaire protocols of the two databases (RE-ENERGIZE and NHIS), certain questions and response options were adjusted to achieve consensus. Although the RE-ENERGIZE data spans 6 years (2016–2021), we chose to utilize only the 2022 NHIS data as it provided all the necessary frailty assessment information due to its rotating design. The use of a general population database and propensity score matching helps to minimize this limitation. Another limitation of our study is that while the NHIS data is US-centric, the RE-ENERGIZE data collection was international, with the majority of patients based in North America. Given that only a limited subset of both populations was sampled, generalizability poses a concern. The extent to which our results can be applied to other populations and settings, particularly low- and middle-income countries, remains uncertain. Baseline differences in co-morbidities were observed between the two groups. The existing literature on illness present on admission following an acute burn is limited and inconclusive [ 64 , 65 ]. Therefore, further research is necessary to determine whether there are genuine disparities in the baseline health of acute burn injury patients compared to the general population. The specific body location is particularly relevant, as injuries to the head and neck, as well as upper and lower extremities, are associated with higher levels of disability and would consequently be linked with elevated FRAIL scores [ 66 ]. Although data on the exact depth of the burns were not provided, all eligible patients for the trial had partial- or full-thickness burns requiring surgery. Generalizability may also pose a concern since only a restricted subset of both populations was sampled. The burn cohort analyzed in this study was defined post hoc and had not been considered in the original power calculation of the sample size. Therefore, it has been previously proposed that statistical hypotheses from post hoc analyses are inherently regarded as exploratory only [ 67 ]. Finally, due to the cross-sectional design of the study, making causal inferences is precluded.
In this study, we conducted an analysis of one of the largest multicenter cohorts of patients with extensive burns to determine the prevalence of frailty in such patients’ months after injury, comparing it to a non-burned general population. Patients with a history of burns exhibit a higher prevalence of frailty compared to the general population group, and these differences are apparent a few months post-discharge, which is typically when burn survivors return to their normal lives. Additionally, we investigated the interrelationship between the presence of frailty and compromise in (instrumental) ADL. By establishing the severity of the issue and describing its impact on quality of life, we aim to identify potential opportunities and avenues for guiding clinical practice, future research, and policymaking efforts.
Datasets generated and analyzed to provide the findings in this study are available from the corresponding author upon reasonable request.
Body mass index
Congestive heart failure/coronary heart disease
Chronic obstructive pulmonary disease
Fatigue, Resistance, Ambulation, Illness, Loss of weight
Instrumental activities of daily living
Intensive care unit
Length of hospital stay
National Health Interview Survey
Randomized Trial of Enteral Glutamine to Minimize the Effects of Burn Injury
36-Item Short Form Health Survey questionnaire
Total body surface area
James SL, Lucchesi LR, Bisignano C, Castle CD, Dingels ZV, Fox JT, et al. Epidemiology of injuries from fire, heat and hot substances: global, regional and national morbidity and mortality estimates from the global burden of Disease 2017 study. Inj Prev. 2020;26(Supp 1):i36–45.
Article PubMed Google Scholar
Clegg A, Young J, Iliffe S, Rikkert MO, Rockwood K. Frailty in elderly people. Lancet. 2013;381(9868):752–62.
Shafiee A, Arabzadeh Bahri R, Rajai S, Ahoopai M, Seighali N, Amini MJ. Frailty as a predictor of adverse outcomes in burn patients: a systematic review. BMC Geriatr. 2023;23(1):680.
Article PubMed PubMed Central Google Scholar
Pereira C, Murphy K, Jeschke M, Herndon DN. Post burn muscle wasting and the effects of treatments. Int J Biochem Cell Biol. 2005;37(10):1948–61.
Article CAS PubMed Google Scholar
Clark A, Imran J, Madni T, Wolf SE. Nutrition and metabolism in burn patients. Burns Trauma. 2017;5:11.
Dauber A, Osgood PF, Breslau AJ, Vernon HL, Carr DB. Chronic persistent pain after severe burns: a survey of 358 burn survivors. Pain Med. 2002;3(1):6–17.
Duke J, Rea S, Semmens J, Edgar DW, Wood F. Burn and cancer risk: a state-wide longitudinal analysis. Burns. 2012;38(3):340–7.
Barrett LW, Fear VS, Waithman JC, Wood FM, Fear MW. Understanding acute burn injury as a chronic disease. Burns Trauma. 2019;7:23.
Pompermaier L, Steinvall I, Elmasry M, Eladany MM, Abdelrahman I, Fredrikson M, et al. Long-term mortality after self-inflicted burns. Burns. 2024;50(1):252–61.
Pompermaier L, Steinvall I, Fredrikson M, Thorfinn J, Sjöberg F. Long-term survival after burns in a Swedish population. Burns. 2017;43(1):157–61.
Panayi AC, Herndon DN, Branski L, Sjöberg F, Hundeshagen G. Bridging frailty and burns: defining acute burn injury as a cause of long-term frailty. Maturitas. 2024;187:108061.
Heyland DK, Wibbenmeyer L, Pollack J, Friedman B, Turgeon AF, Eshraghi N, et al. A randomized trial of enteral glutamine for treatment of burn injuries. N Engl J Med. 2022;387(11):1001–10.
Institute of Medicine (US). Committee on a National Surveillance System for Cardiovascular and Select Chronic diseases. A nationwide framework for surveillance of cardiovascular and chronic lung diseases. Washington (DC): National Academies Press (US); 2011.
Google Scholar
Heyland DK, Wischmeyer P, Jeschke MG, Wibbenmeyer L, Turgeon AF, Stelfox HT, et al. A RandomizEd trial of ENtERal glutamine to minimIZE thermal injury (the RE-ENERGIZE trial): a clinical trial protocol. Scars Burn Heal. 2017;3:2059513117745241.
PubMed PubMed Central Google Scholar
van Abellan G, Rolland YM, Morley JE, Vellas B. Frailty: toward a clinical definition. J Am Med Dir Assoc. 2008;9(2):71–2.
Article Google Scholar
Morley JE, Vellas B, van Kan GA, Anker SD, Bauer JM, Bernabei R, et al. Frailty consensus: a call to action. J Am Med Dir Assoc. 2013;14(6):392–7.
Hyde Z, Flicker L, Almeida OP, Hankey GJ, McCaul KA, Chubb SA, et al. Low free testosterone predicts frailty in older men: the health in men study. J Clin Endocrinol Metab. 2010;95(7):3165–72.
Lopez D, Flicker L, Dobson A. Validation of the frail scale in a cohort of older Australian women. J Am Geriatr Soc. 2012;60(1):171–3.
Morley JE, Malmstrom TK, Miller DK. A simple frailty questionnaire (FRAIL) predicts outcomes in middle aged African americans. J Nutr Health Aging. 2012;16(7):601–8.
Article CAS PubMed PubMed Central Google Scholar
Woo J, Leung J, Morley JE. Comparison of frailty indicators based on clinical phenotype and the multiple deficit approach in predicting mortality and physical limitation. J Am Geriatr Soc. 2012;60(8):1478–86.
Wolters M, Volkert D, Streicher M, Kiesswetter E, Torbahn G, O’Connor EM, et al. Prevalence of malnutrition using harmonized definitions in older adults from different settings - a MaNuEL study. Clin Nutr. 2019;38(5):2389–98.
Shelkey M, Wallace M. Katz index of independence in activities of daily living (ADL). Director. 2000;8(2):72–3.
CAS PubMed Google Scholar
Lawton MP, Brody EM. Assessment of older people: self-maintaining and instrumental activities of daily living. Gerontologist. 1969;9(3):179–86.
Yang M, Ding X, Dong B. The measurement of disability in the elderly: a systematic review of self-reported questionnaires. J Am Med Dir Assoc. 2014;15(2):e1501–9.
Palmer M, Harley D. Models and measurement in disability: an international review. Health Policy Plan. 2012;27(5):357–64.
Ren C, Hao X, Chen X, Liu X. Loneliness, functional disability and lower urinary tract symptoms suggestive of benign prostatic hyperplasia in aging men: insights from the China health and retirement longitudinal study. Geriatr Nurs. 2024;58:304–9.
Pinto JO, Pontes D, Dores AR, Peixoto B, Barbosa F. Activities of daily living inventory (ADLI): proposal of a new instrument and preliminary data. Appl Neuropsychol Adult. 2024:1–18.
Ren Z, Nie L, Du Y, Zhou T, Sun J, Liu J. Joint daily functional trajectory and risk of new-onset Alzheimer’s disease and related dementias in older adults with normal and abnormal weight. J Affect Disord. 2024;358:157–62.
Huang MH, Tsai CF, Lin YS, Kuo YS, Hsu CC, Fuh JL. A national survey on health-related quality of life for people with dementia in residential long-term care institutions. J Formos Med Assoc. 2024;123(7):764–72.
Flanagan KD, Cornell DJ, Mangano KM, Zhang X, Tucker KL, Noel SE. Adherence to mediterranean, dietary approaches to stop hypertension and healthy eating indices are associated with lower risk of disability among Puerto Rican adults from the longitudinal Boston Puerto Rican Health study. Am J Clin Nutr. 2024:S0002-9165(24)00528-8.
Woldemariam S, Stein VK, Haider S, Dorner TE. Trends over time in the deficit of (instrumental) activities of daily living in the Austrian population aged 65 years and older: results from the Austrian health interview Survey series. Wien Klin Wochenschr. 2024. https://doi.org/10.1007/s00508-024-02388-4 .
Pashmdarfard M, Azad A. Assessment tools to evaluate activities of daily living (ADL) and instrumental activities of daily living (IADL) in older adults: a systematic review. Med J Islam Repub Iran. 2020;34:33.
Rassen JA, Shelat AA, Myers J, Glynn RJ, Rothman KJ, Schneeweiss S. One-to-many propensity score matching in cohort studies. Pharmacoepidemiol Drug Saf. 2012;21(Suppl 2):69–80.
Jeschke MG, van Baar ME, Choudhry MA, Chung KK, Gibran NS, Logsetty S. Burn injury. Nat Rev Dis Primers. 2020;6(1):11.
Haug VF, Tapking C, Panayi AC, Thiele P, Wang AT, Obed D, et al. Long-term sequelae of critical illness in sepsis, trauma and burns: a systematic review and meta-analysis. J Trauma Acute Care Surg. 2021;91(4):736–47.
Goede V, Neuendorff NR, Schulz RJ, Hormigo AI, Martinez-Peromingo FJ, Cordoba R. Frailty assessment in the care of older people with haematological malignancies. Lancet Healthy Longev. 2021;2(11):e736–45.
Bourgi J, Sleiman Z, Fazaa E, Maasarani D, Chahine Y, Nassif E, et al. Predictors of generic and burn-specific quality of life among adult burn patients admitted to a Lebanese burn care center: a cross-sectional single-center study. Int J Burns Trauma. 2020;10(3):81–9.
Jafaryparvar Z, Adib M, Ghanbari A, Ali Yazdanipour M. Predictors of short-term outcomes of burn in a newly established burn centre in Iran. Nurs Open. 2021;8(6):2986–95.
Hundeshagen G, Herndon DN, Clayton RP, Wurzer P, McQuitty A, Jennings K, et al. Long-term effect of critical illness after severe paediatric burn injury on cardiac function in adolescent survivors: an observational study. Lancet Child Adolesc Health. 2017;1(4):293–301.
Hussain A, Dunn KW. Predicting length of stay in thermal burns: a systematic review of prognostic factors. Burns. 2013;39(7):1331–40.
Pompermaier L, Steinvall I, Fredrikson M, Sjöberg F. Inclusion of coexisting morbidity in a TBSA% and age based model for the prediction of mortality after burns does not increase its predictive power. Burns. 2015;41(8):1868–76.
Karam E, Lévesque MC, Jacquemin G, Delure A, Robidoux I, Laramée MT, et al. Building a multidisciplinary team for burn treatment - lessons learned from the Montreal tendon transfer experience. Ann Burns Fire Disasters. 2014;27(1):3–7.
CAS PubMed PubMed Central Google Scholar
World Federation of Occupational Therapists. World federation of occupational therapists’ position statement on telehealth. Int J Telerehabil. 2014;6(1):37–9.
Article PubMed Central Google Scholar
Lemay J, Waheedi M, Al-Sharqawi S, Bayoud T. Medication adherence in chronic illness: do beliefs about medications play a role? Patient Prefer Adherence. 2018;12:1687–98.
Kvarnström K, Westerholm A, Airaksinen M, Liira H. Factors contributing to medication adherence in patients with a chronic condition: a scoping review of qualitative research. Pharmaceutics. 2021;13(7):1100.
Lang PO, Michel JP, Zekry D. Frailty syndrome: a transitional state in a dynamic process. Gerontology. 2009;55(5):539–49.
Bales CW, Ritchie CS. Sarcopenia, weight loss, and nutritional frailty in the elderly. Annu Rev Nutr. 2002;22:309–23.
Price C. Nutrition: reducing the hypermetabolic response to thermal injury. Br J Nurs. 2018;27(12):661–70.
Adjepong M, Agbenorku P, Brown P, Oduro I. The role of antioxidant micronutrients in the rate of recovery of burn patients: a systematic review. Burns Trauma. 2016;4:18.
Haba Y, Fujimura T, Oyama K, Kinoshita J, Miyashita T, Fushida S, et al. Effect of oral branched-chain amino acids and glutamine supplementation on skeletal muscle atrophy after total gastrectomy in rat model. J Surg Res. 2019;243:281–8.
Mignon M, Lêvêque L, Bonnel E, Meynial-Denis D. Does glutamine supplementation decrease the response of muscle glutamine synthesis to fasting in muscle in adult and very old rats? JPEN J Parenter Enter Nutr. 2007;31(1):26–31.
Article CAS Google Scholar
Meynial-Denis D. Glutamine metabolism in advanced age. Nutr Rev. 2016;74(4):225–36.
Maykish A, Sikalidis AK. Utilization of hydroxyl-methyl butyrate, leucine, glutamine and arginine supplementation in nutritional management of Sarcopenia-implications and clinical considerations for type 2 diabetes mellitus risk modulation. J Pers Med. 2020;10(1):19.
Smith-Ryan AE, Hirsch KR, Saylor HE, Gould LM, Blue MNM. Nutritional considerations and strategies to facilitate injury recovery and rehabilitation. J Athl Train. 2020;55(9):918–30.
Volkert D, Beck AM, Cederholm T, Cereda E, Cruz-Jentoft A, Goisser S, et al. Management of malnutrition in older patients-current approaches, evidence and open questions. J Clin Med. 2019;8(7):974.
Dombrecht D, Van Daele U, Van Asbroeck B, Schieffelers D, Guns PJ, Gebruers N, et al. Molecular mechanisms of post-burn muscle wasting and the therapeutic potential of physical exercise. J Cachexia Sarcopenia Muscle. 2023;14(2):758–70.
Evans WJ. Skeletal muscle loss: cachexia, Sarcopenia, and inactivity. Am J Clin Nutr. 2010;91(4):S1123–7.
Rivas E, Tran J, Gutierrez IL, Chapa M, Herndon DN, Suman OE. Rehabilitation exercise increases physical activity levels in severely burned children while improving aerobic exercise capacity and strength. J Burn Care Res. 2018;39(6):881–6.
Disseldorp LM, Nieuwenhuis MK, Van Baar ME, Mouton LJ. Physical fitness in people after burn injury: a systematic review. Arch Phys Med Rehabil. 2011;92(9):1501–10.
Panayi AC, Heyland DK, Stoppe C, Jeschke MG, Didzun O, Matar D, et al. The long-term intercorrelation between post-burn pain, anxiety, and depression: a post hoc analysis of the RE-ENERGIZE double-blind, randomized, multicenter placebo-controlled trial. Crit Care. 2024;28(1):95.
Mutz J, Choudhury U, Zhao J, Dregan A. Frailty in individuals with depression, bipolar disorder and anxiety disorders: longitudinal analyses of all-cause mortality. BMC Med. 2022;20(1):274.
Meuli JN, Pantet O, Berger MM, Waselle L, Raffoul W. Massive burns: retrospective analysis of changes in outcomes indicators across 18 years. J Burn Care Res. 2022;43(1):232–9.
Gong J, Singer Y, Cleland H, Wood F, Cameron P, Tracy LM, et al. Driving improved burns care and patient outcomes through clinical registry data: a review of quality indicators in the Burns Registry of Australia and New Zealand. Burns. 2021;47(1):14–24.
Salehi SH, As’adi K, Abbaszadeh-Kasbi A. The prevalence of comorbidities among acute burn patients. Trauma. 2019;21(2):134–40.
Aggarwal A, Chittoria RK, Chavan VK, Gupta S, Reddy CL, PMohan PB, et al. The role of comorbidieites in the prognosis of thermal burns. Indian J Burn. 2019;27:16–9.
McAleavey AA, Wyka K, Peskin M, Difede J. Physical, functional, and psychosocial recovery from burn injury are related and their relationship changes over time: a burn Model System study. Burns. 2018;44(4):793–9.
Günter CI, Ilg FP, Hapfelmeier A, Egert-Schwender S, Jelkmann W, Giri S, et al. Relation between gender and concomitant medications with erythropoietin-treatment on wound healing in burn patients. Post hoc subgroup-analysis of the randomized, placebo-controlled clinical trial EPO in burns. Front Pharmacol. 2022;13:812888.
Download references
This work was supported by the U.S. Department of Defense (W81XWH-09-2-0194 for the pilot phase), and the Canadian Institutes of Health Research (MCT-94834 for the pilot phase and 14238 for the definitive phase).
Authors and affiliations.
Department of Hand, Plastic and Reconstructive Surgery, Burn Center, BG Trauma Center Ludwigshafen, University of Heidelberg, 67071, Ludwigshafen, Germany
Adriana C. Panayi, Christian Tapking, Oliver Didzun, Amir K. Bigdeli, Ulrich Kneser & Gabriel Hundeshagen
Clinical Evaluation Research Unit, Department of Critical Care Medicine, Queen’s University, Kingston, ON, K7L 3N6, Canada
Daren K. Heyland
Department of Anaesthesiology, Intensive Care, Emergency and Pain Medicine, University Hospital Würzburg, 97080, Würzburg, Germany
Christian Stoppe
Department of Cardiac Anesthesiology and Intensive Care Medicine, Charité Berlin, 10117, Berlin, Germany
Hamilton Health Sciences Research, Department of Surgery, McMaster University, Hamilton, ON, L8S 4L8, Canada
Marc G. Jeschke
Division of Plastic Surgery, Department of Surgery, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA, 02115, USA
Samuel Knoedler & Dennis P. Orgill
Burns Center and Plastic Surgery, Unfallkrankenhaus Berlin, 12683, Berlin, Germany
Valentin Haug
You can also search for this author in PubMed Google Scholar
ACP was involved in the conceptualization of the study, data collection, methodology, statistical analysis, data visualization, and writing of the original draft. DKH, CS, and MGJ were involved in the data collection and the review and editing of the manuscript. SK was involved in the methodology, statistical analysis, and the review and editing of the manuscript. CT was involved in the writing of the original draft. OD, VH, AKB, and UK were involved in the review and editing of the manuscript. DPO was involved in the methodology and the review and editing of the manuscript. GH was involved in the conceptualization of the study, data collection, methodology, and writing of the original draft.
Correspondence to Gabriel Hundeshagen .
Ethics approval and consent to participate.
The protocol for the RE-ENERGIZE trial was approved by the Ethics Committees at Queen’s University, Kingston, Ontario, Canada (Approval number: NCT00985205; https://clinicaltrials.gov/study/NCT00985205 ) and at all other participating centers. The entities that provided support, financial or product, had no role in the protocol design, conduct of the trial, or data analysis. The also did not have access to the data or manuscript prior to publication. Written informed consent was obtained from each subject or a designated surrogate prior to randomization.
No applicable.
The authors declare that they have no competing interests.
Publisher’s note.
Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
Additional file 1: fig. s1.
Quality of matching visualized as a histogram. Fig. S2 Quality of matching visualized as a jitter plot. Fig. S3 ADL and iADL scores assessed over the follow-up period in months. Fig. S4 Theoretic schematic depicting the potential impact of frailty on patients with a history of burn injury.
Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ . The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/ ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
Reprints and permissions
Cite this article.
Panayi, A.C., Heyland, D.K., Stoppe, C. et al. Frailty as a sequela of burn injury: a post hoc analysis of the “RE-ENERGIZE” multicenter randomized-controlled trial and the National Health Interview Survey. Military Med Res 11 , 63 (2024). https://doi.org/10.1186/s40779-024-00568-x
Download citation
Received : 20 April 2024
Accepted : 19 August 2024
Published : 12 September 2024
DOI : https://doi.org/10.1186/s40779-024-00568-x
Anyone you share the following link with will be able to read this content:
Sorry, a shareable link is not currently available for this article.
Provided by the Springer Nature SharedIt content-sharing initiative
ISSN: 2054-9369
This blog post is part of our Research Article of the Month series. For this month, we highlight “ Universal Screening in Grades K–2: A Systematic Review and Meta-Analysis of Early Reading Curriculum-Based Measures ,” an article published in the Journal of School Psychology in 2020. Important words related to research are bolded, and definitions of these terms are included at the end of the article in the “Terms to Know” section.
A universal screener is a tool teachers use to identify students who may be at risk for literacy difficulties. It is an assessment given to all students several times a year to identify which students are below, at, or above a certain benchmark at a specific point in time. Screening helps teachers identify students who could benefit from additional support or accelerated instruction. It is especially important in early elementary grades so potential difficulties with reading can be identified and addressed as early as possible.
One kind of assessment used for universal screening is a curriculum-based measure (CBM). CBMs are short, timed assessments that track an individual student’s progress toward a learning goal. Some CBMs measure a specific skill associated with reading ability, such as word identification or letter-sound knowledge. For example, a CBM that assesses letter-sound knowledge might require a student to produce the sounds associated with each letter from a list.
Given the prevalence of CBM assessments in universal screening, it is important to understand the validity of these assessments—the extent to which these assessments measure the skill they are designed to measure. This includes concurrent validity (the extent to which student performance on one assessment is confirmed by their performance on another assessment designed to measure the same skill) and predictive validity (the extent to which student performance on one assessment predicts their performance on another assessment administered at a later time). Understanding the validity of CBMs can help educators select universal screening measures that accurately identify students who would benefit from additional support in reading.
The researchers aim to evaluate the validity of early reading CBMs administered in Grades K – 2. The purposes of the study are as follows:
Note: The authors also intended to assess the classification accuracy of CBMs, but the majority of articles in this meta-analysis did not report the data necessary for this analysis, so the authors were unable to address this purpose of the study. To learn more about the classification accuracy of screeners, read our January 2024 Research Article of the Month .
The authors conducted a meta-analysis of 54 empirical studies that examined the relationship between early reading CBMs and other measures of reading outcomes. To be included in the analysis, the studies needed to:
For each of the included studies, researchers examined the students’ performance on a CBM and another student reading outcome measure (e.g., broad reading achievement, reading comprehension and vocabulary, language and listening, oral reading, phonics, or phonological and phonemic awareness).
Researchers also took into account other variables in the studies that could affect students’ reading outcomes. These variables included:
The researchers conducted separate random effects models for concurrent and predictive validity to estimate the correlation between early reading CBMs and other reading outcome measures. The researchers calculated the correlation coefficients for each reading outcome separately, when possible. However, when there were insufficient data to support this kind of analysis, the outcome measures were aggregated to ensure more reliable results.
For the purposes of this study, correlation coefficients were classified as concurrent when the reading outcome measure was administered less than a month after the CBM, and as predictive when the reading outcome measure was administered a month or more after the CBM. The researchers examined the extent to which this administration lag moderated the correlation between early reading CBMs and other reading outcome measures.
Alphabet knowledge.
In the studies included in this meta-analysis, there were two early reading CBMs that measured alphabet knowledge: letter sounds and letter naming. These CBMs were only administered in kindergarten and first grade. There was a large concurrent correlation (r = 0.552) between the letter sounds CBM and the composite outcome measure, consisting of phonics, oral reading, and broad reading. Similarly, there was a large concurrent correlation (r = 0.571) between the letter naming CBM and the aggregated outcome measure, consisting of phonics, broad reading, and oral reading. Concerning the abilities of these CBMs to predict students’ future performance, the letter sounds CBM had a large predictive association (r = 0.56) with complex reading skills (a composite of phonics, comprehension, and broad reading outcomes). Similarly, the predictive association between the letter naming CBM and other reading outcomes was also large, ranging from 0.52 for broad reading to 0.64 for oral reading. However, the predictive ability of the letter naming CBM was moderated by administration lag. For every month increase in the lag between the administration of the letter naming CBM and the administration of the outcome measure, the correlation coefficient decreased by 0.01. In other words, the more time that passes between the administration of both assessments, the less accurately the letter naming CBM predicts a student’s later performance.
In the studies included in this meta-analysis, there were two early reading CBMs that measured phonemic awareness: onset sounds and phoneme segmenting. Onset sounds was only administered in kindergarten, whereas phoneme segmenting was administered in both kindergarten and first grade. The correlation coefficients of these CBMs were smaller than those of the alphabet knowledge CBMs. The onset sounds CBM had a medium concurrent correlation (r = 0.43) with more complex reading skills. Similarly, the phoneme segmenting CBM had a medium concurrent correlation with both phonics and phonological awareness (r = 0.43) and complex reading skills (r = 0.34). Concerning the predictive abilities of these CBMs, there was a medium predictive correlation (r = 0.424) between the onset sounds CBM and the aggregated outcome measure, consisting of phonics, oral reading, broad reading, and comprehension. Similarly, there was a medium predictive correlation between the phoneme-segmenting CBM and the other outcome measures, ranging from 0.350 for oral reading to 0.376 for phonics. These predictive correlations were not moderated by administration lag.
Two CBMs in the studies included in this meta-analysis measured decoding skills: nonsense words and word identification. The nonsense words CBM was administered across Grades K–2, whereas the word identification CBM was administered primarily in first grade. Concurrent associations between the nonsense words CBM and other reading skills were large, ranging from 0.60 for broad reading ability to 0.75 for oral reading. Similarly, the word identification CBM had a large concurrent association with complex reading skills (r = 0.70). Concerning the ability of these CBMs to predict students’ later performance, the nonsense words CBM had large predictive correlations with outcome measures, ranging from 0.52 for oral reading to 0.68 for broad reading. However, administration lag was a significant moderator for the nonsense words CBM. Predictive correlations between the word identification CBM and other reading outcomes were also large, ranging from 0.71 for broad reading and comprehension to 0.83 for oral reading. In contrast to the nonsense words CBM, administration lag was not significant for the word identification CBM.
The study explores the validity of early reading CBMs in identifying at-risk students in Grades K–2. One of the key findings is that CBMs can reliably predict later reading outcomes, particularly for skills including phonics, oral reading, and letter naming. Practically, these findings underscore the importance of timely and frequent assessments to accurately predict students’ later performance and shed light on their reading development. For teachers, this suggests that using CBMs frequently, such as multiple times per school year, can help them identify students who could benefit from additional support or early intervention. Additionally, schools can choose CBM tools that align closely with their instructional goals and refine their universal screening processes to identify early signs of potential reading difficulties. For example, if the goal is to predict decoding skills, CBMs that assess nonsense words and word identification have demonstrated strong predictive validity. These CBMs could support data-based decisions in the classroom and help ensure that students receive appropriate support in the early stages of reading development.
Due to the lack of data reported in the included studies, the researchers were unable to explore how student demographic factors, such as race and ethnicity, socioeconomic background, or English Learner status might have influenced the findings. Thus, it is unclear whether CBMs perform comparably well for all student groups. Furthermore, it is difficult to know if these assessments might have different levels of accuracy or predictive validity for students from diverse backgrounds. Further research on these demographic factors would benefit educators and schools to ensure that CBMs are equitable and effective for all learners. Additionally, the study showed large variability, or heterogeneity, between the included studies, in terms of the sample sizes, regions, and specific CBM tools used. While a robust variance estimation method was used to account for this, the variability in how and when CBMs were administered across different contexts could affect the generalizability of the results.
Cohen, J. (2013). Statistical power analysis for the behavioral sciences . Routledge.
January, S. A., & Klingbeil, D. A. (2020). Universal screening in grades K–2: A systematic review and meta-analysis of early reading curriculum-based measures. Journal of School Psychology , 82 , 103–122. https://doi.org/10.1016/j.jsp.2020.08.007
BMC Health Services Research volume 24 , Article number: 1037 ( 2024 ) Cite this article
Metrics details
The Lao People’s Democratic Republic (Lao PDR), a lower-middle income country, has a higher malnutrition rate than other Southeast Asian countries. The decentralization of healthcare is a determinant of the effectiveness of programs to reduce malnutrition, but no study has focused on this factor in this country. This organizational study explores the state of decentralization of the healthcare system in Lao PDR that underlies the nutrition programs in the country.
A qualitative study, which is based on a neo-institutional theory conceptual framework, explored factors related to dominant structure (laws, regulations, resources) and interpretative schemes (dominant ideas and beliefs) that characterize the nutrition services provided in the Lao healthcare system. Twenty-four semistructured interviews were performed with representatives of healthcare institutions involved in nutrition programs at different government levels, external donors and civil society organizations. The interviews were completed with relevant documents. The analysis focused on the convergence of interpretative schemes of the organizations concerned and the coherence between the structure underpinning the nutrition programs and the interpretative schemes.
Services deployed to reduce malnutrition in the Lao PDR remain largely centralized, despite factors specific to the country that led it to promote decentralization of its services. The convergence of interpretive schemes and the coherence between the observed structure and the interpretative schemes of actors at all governance levels ensure the stability of this state of decentralization, which has persisted for almost 50 years.
Nutrition programs in the Laos PDR are largely under the responsibility of the central government. The transformations in the healthcare system, notably with the use of new information technologies and the fact that the provinces are populated by a growing number of professionals trained in nutrition in addition to factors that push the system to be decentralized, such as ethnic diversity, the increasing availability of human resources in provinces, and the use of communication technologies, are not strong enough to change the balance of power between governance levels. The deconcentration that characterizes decentralization is therefore likely to continue for the foreseeable future.
Peer Review reports
The World Health Organization (WHO) defines malnutrition as deficiencies, excesses, or imbalances in a person’s intake of energy and/or nutrients, encompassing three broad groups of conditions: undernutrition (including wasting, stunting, and underweight); micronutrient-related malnutrition (including deficiencies or excesses of essential vitamins and minerals); and overweight, obesity, and diet-related noncommunicable diseases [ 1 ]. Undernutrition and micronutrient-related malnutrition are the main issues generally addressed by nutrition interventions aimed at five-year-old children in developing countries [ 2 , 3 ]. Children under 5 in lower-middle-income countries are particularly vulnerable to undernutrition and its lifelong effects [ 4 , 5 ], which manifest as wasting (acute undernutrition or severe weight loss due to insufficient food intake and/or infectious disease), stunting (chronic undernutrition leading to low height-for-age and irreversible long-term physical and cognitive damage), and underweight (low weight-for-age, potentially indicating stunting, wasting, or both) [ 5 ]. The WHO highlights that nearly half of deaths among children under 5 years of age are linked to undernutrition. These deaths predominantly occur in low-and middle-income countries [ 1 ].
Undernutrition among children under five years of age is a public health priority in the Lao PDR [ 6 ]. The prevalence of stunting, an indicator often used to estimate the prevalence of chronic malnutrition, is among the highest in East Asia [ 7 ], with a national rate estimated at 31.5% in 2022 [ 8 ]. This rate surpasses those in neighboring lower-middle-income countries, such as Vietnam (20%), Cambodia (22%), and Myanmar (27%) [ 9 ]. According to the WHO standards, stunting is considered critical if it exceeds the threshold of 30% [ 5 ]. Acute malnutrition, estimated by the prevalence of wasting, is still a public health problem among children under five years of age in Lao PDR. The prevalence of wasting is 10%, which is the same as that in Cambodia but higher than that in Myanmar (7%) and Vietnam (5%) [ 9 ]. Furthermore, the problem of malnutrition is unevenly distributed across the territory of Lao PDR. Rural and ethnic minority children are at greater risk of stunting than are urban and majority ethnic groups [ 10 ]. There was a 15% lower risk of stunting for urban children than for their rural counterparts (24% vs. 39%). In Phongsaly Province, the stunting prevalence is as high as 54%, in contrast to the 14% reported in the Vientiane Capital. Additionally, the prevalence of wasting was the lowest in the province of Luangnamtha (3%) and highest in the province of Xayabury (19%) [ 11 ].
The state of healthcare system decentralization has been shown to be a determinant of nutritional status in developing countries [ 12 , 13 ]. Decentralization involves transferring power and responsibility from the central government to lower levels of governance, impacting healthcare service accessibility, quality, and equity [ 14 , 15 , 16 , 17 ]. Decentralization is commonly categorized into three major forms: 1) Deconcentration involves the central government handing over some authority to local administrative offices within the health ministry, allowing local management to handle health-related activities with some discretion; 2) Delegation entails the central government transferring defined managerial and administrative functions to institutions outside the central government's hierarchical structure, which are indirectly controlled by the health ministry; and 3) Devolution refers to the central government legally transferring power to locally elected political organs that operate independently of the central government in specific functions [ 15 ].
Lao PDR has a deconcentration form of decentralization [ 18 , 19 ]. While local levels can provide input for program adaptation to local needs, ultimate control remains with the central government, which can veto decisions made by regional or local health offices [ 20 , 21 ]. In Lao PDR, the dynamics and forces influencing the current state of decentralization are shaped by the country's unique historical-political context and distinctive population characteristics. These factors contribute to the complex nature of power sharing across different government levels. The first factor is related to the historical concept of Lao PDR, which is rooted in the notion of " meuang "[ 22 ]. A meuang is a walled city led by a local ruler overseeing surrounding settlements and villages [ 22 , 23 ]. Each meuang maintained its governance, with oversight and protection from the kingdom but without interference in internal affairs. While the nineteenth century shift toward a centralized state model introduced Western administrative practices, the meuang concept remains deeply ingrained in Lao society, lending historical legitimacy to decentralization forces [ 22 , 24 ]. The second factor is the country's ethnic diversity. The country has 49 official minority groups constituting nearly half the population. Minorities often reside in remote areas [ 25 ]. Decentralizing power and assigning responsibilities to local levels is expected to empower authorities to more effectively customize health programs to meet the diverse needs of the population.
These decentralizing forces are counterbalanced by centralizing forces due in great part to the sociocultural context influenced by Confucianist ideology, which emphasizes social harmony and respect for authority and promotes political centralization in East Asia, including Lao PDR [ 26 , 27 , 28 ]. Moreover, the limited human and financial resources of the central government, which still rely heavily on donor funding, push toward the centralization of the healthcare system and program functioning [ 29 , 30 , 31 ]. From an organizational perspective, these factors create a complex balance between decentralization and centralization in the Lao healthcare system.
Little work has been done in Lao PDR on how the state of decentralization affects the functioning of public health programs, despite being an organizational determinant of health. This organizational study examines the status of decentralization of the healthcare system in Lao PDR and its influence on the National Nutrition Policy.
The conceptual framework used in this study was based on neo-institutional theory (NIT) [ 32 , 33 ]. NITs view organizations as social structures that must conform to the expectations and pressures of their institutional environment, which includes normative and regulatory forces [ 34 , 35 ]. This approach was considered relevant for this study because decentralization is an institutionalized concept. The form of decentralization that underlies the nutrition policy in the country arises from sociohistorical and legal factors that institutionalize the distribution of powers that govern the functioning of the policy.
Different NIT conceptual frameworks have been proposed. The one used in this study is the one that was proposed by Hinings and Greenwood in 1988 [ 36 ]. It considers the dialectic between the structure, i.e., the laws, rules, and resources that constrain the work performed in an organization, and the interpretive schemes and their meaning-making processes that shape individual and collective behavior that are dominant in a society, i.e., the dominant ideas and beliefs [ 36 , 37 ]. This dialectic approach has been widely used in studies on public policies concerning the nature of institutional structures [ 38 , 39 , 40 , 41 , 42 ]. From these two dimensions, the structural dimension emphasizes the importance of formalizing corporate values and standards in the organization’s standardized policies and procedures, formalizing decision-making processes, and creating hierarchical structures to ensure compliance with institutionalized environmental factors. On the other hand, the interpretive schemes dimension focuses on the importance of shared meanings and beliefs in shaping organizational behaviors [ 32 , 43 ]. This dimension emphasizes that organizations are influenced by both individual and shared beliefs, values, and norms within their institutional environment. These elements shape the organizational actors' understanding and interpretation of what constitutes legitimate and appropriate behaviors [ 35 , 44 , 45 ]. By doing so, organizations can gain legitimacy and ensure their survival in complex and dynamic institutional environments [ 34 , 35 , 45 , 46 ].
A case study based on an ethnographic design was conducted to examine patterns of social organization and ideational systems that underlie formal/informal structures, as well as the dominant values, behaviors and beliefs of the groups involved in nutrition interventions in Lao PDR [ 47 , 48 , 49 ]. The data were collected from documents and semistructured interviews with representatives of governmental organizations, nongovernmental organizations (NGOs), and civil society organizations (CSOs) involved in nutrition programs in four provinces of Lao PDR. The nutrition programs in this study are those that align with the Lao National Nutrition Plans and Strategies; they encompass interventions and programs from the health and other sectors that are expected to positively influence nutritional indicators. The data were collected between January and June 2022.
Interview Guide
An interview guide (see Fig. 1 ) was developed for this study based on the dimensions of the conceptual framework. This interview guide included a pretest with three members of the Lao Tropical and Public Health Institute (Lao TPHI), who has experience in nutrition research in Lao PDR. These individuals were not part of the study's participants. The participants were asked about their current state of malnutrition in Lao PDR and changes over time, as well as insights into power sharing among government levels and external actors. The questions also covered the organization’s experiences and responsibilities in the field of nutrition. Discussions have further explored perspectives on structural elements (policies, regulations, rules) and common beliefs affecting the healthcare system's ability to address nutrition issues.
To capture the diversity of the country, the latest available national-level data on nutritional status were presented for three provinces with contrasting nutrition situations: Luangnamtha, Xayabury, and Saravan (Table 1 ). Vientiane capital was chosen because of its status as the location of the Ministry of Health (MoH) and national child nutrition-focused institutions (Maternal and Child Health Center and Nutrition Center), as well as the headquarters of development donors and civil society organizations. Luangnamtha, a northern province and one of the most economically developed in the country, has seen remarkable improvements in nutrition indicators. Xayabury, which is also in the north and adjacent to the capital, has experienced little improvement in terms of stunting and underweight rates, with an increase in wasting in recent years. Saravan, in the southern region and one of the poorest provinces of the country, has among the highest prevalence rates of all types of malnutrition, with no significant changes in recent years [ 50 , 51 ].
Two sources of information were used for the analysis in this study: interviews with representatives of key institutions and relevant documents [ 52 ].
The following criteria were used to recruit participants for individual interviews. The participants had to 1) occupy a formal position in relation to nutrition within their organization; 2) be in their current position for at least one year; 3) be authorized to speak on behalf of their organization regarding projects related to nutrition in children under five years of age; and 4) be able to speak one of the languages spoken by the interviewer: Lao (official language), English, or French.
A purposeful sampling approach was used to constitute the sample [ 53 , 54 ]. A preliminary list of participants was created by one of the researchers (SK). At the end of each interview, the participants were asked to suggest additional organizations or individuals who could offer different perspectives. This snowball sampling method aimed to diversify opinions until data saturation was achieved [ 47 , 55 ].
Following administrative protocols, a project summary and discussion topics were initially sent to organization directors for approval. The latter identified individuals within their organization who might have participated in the study. These persons were contacted and asked for their permission to receive project details via fax, WhatsApp, or email. Any queries were addressed through phone calls. If the solicited person agreed, they signed a consent form. The interviews were subsequently scheduled at a mutually convenient time. The participants could choose between face-to-face or online videoconference interviews (Zoom or Google Meet). The interviews, which lasted 45 to 90 min, were audio-recorded with consent, and handwritten notes were taken for documentation and impressions.
To supplement the information provided during the interviews, all documents written in English, Lao, or French on nutrition policies and power sharing between different government levels in Lao PDR were also analyzed. These documents included published academic papers, documents provided by individuals who were interviewed, and documents found on the website of their organization.
All interviews conducted in Lao or French were translated into English by the interviewer and sent to the coauthor who has the least mastery of the Lao language. The realism of the translation was verified by sending a first version of the analyses to three people interviewed, who had to confirm that they found their opinions there. The interviews and document content were analyzed using NVivo 11 software. The interviews and document contents were subsequently analyzed through four main steps: 1) data coding (where data were segmented into meaningful units such as phrases, sentences, or paragraphs); 2) categorization (coded data were then grouped into themes or concepts); 3) coding of themes in connection with the conceptual framework; and 4) comparison of emerging information with published studies on the topic [ 56 ].
The analysis was performed using an inductive-deductive approach [ 57 , 58 ]. The validity of the results was ensured by four elements: 1) credibility based on the triangulation of information provided by multiple sources; 2) transferability through a detailed description of the participants, research process and study context to help the reader judge the relevance of the results for another context [ 59 , 60 ]; 3) reliability based on analyses performed independently by the researcher and one of her supervisors and the search for a consensus between them in case of discrepancy; and 4) confirmability through a detailed and transparent record of the research process, including the data collection, analysis, interpretation and discussion notes from the meetings with coresearchers [ 61 ].
Twenty-four semistructured interviews were conducted with representatives of key organizations: government institutions, United Nations (UN) agencies, international nongovernmental organizations (NGOs), and civil society organizations (CSOs). The participants were primarily women (16 out of 24). The average age was 47 years, with a range from 32 to 61 years. Three participants worked in the healthcare system at the central level, five at the provincial level, five at the district level, and three in health centers (formally known as small hospitals). Three participants worked for UN agencies, and two worked for NGOs. One was a consultant, and two were active members of civil society associations. Twenty-two interviews were conducted in the Lao language (Table 2 ).
Eleven documents were analyzed: 1) Fiscal Decentralization in the People’s Democratic Republic of Lao; 2) Decentralization in Lao PDR: A case study of the Effectiveness of Three Build Directive Policy on Local Authority; 3) the role of Marxism in the Lao political system in the contemporary era; 4) the health system review of Lao PDR in 2014; 5) the Prime Minister’s Decree No. 570 on the organizations and operations of the Ministry of Health in 2021; 6) the National Plan of Action on Nutrition (NPAN) 2021–2025; 7) the National Immunization Programme. Updated Comprehensive Multi-Year Plan Lao PDR 2019–2023; 8) Government spending on health in Lao PDR in 2012; 9) National Nutrition Policy in 2008; 10) National Nutrition strategies to 2025 and Plan of Action 2016–2020; and 11) Operational guideline for the implementation of the National Plan of Action on Nutrition (NPAN) 2021 to 2025 [ 6 , 18 , 19 , 62 , 63 , 64 , 65 , 66 , 67 , 68 , 69 ].
Formally, the decentralization of the Lao health system is of the deconcentration type (Fig. 2 ). The Ministry of Health (MoH) oversees the entire healthcare system, which operates across three levels of governance: central, provincial, and district. Provincial and district health authorities’ main responsibility is to ensure that health facilities comply with centrally defined rules [ 6 , 65 ]. Private providers must adhere to centrally defined regulations [ 6 ].
Government-level power sharing in Lao PDR. Sources: Health System Review in Lao 2014; National Plan of Action on Nutrition (NPAN) 2021–2025; National Immunization Programme: Updated Comprehensive Multi-Year Plan Lao PDR 2019–2023; and the Prime Minister’s Decree No. 570 on the organizations and operations of the Ministry of Health in 2021 [ 6 , 63 , 64 , 68 ]
All decisions concerning human and financial resources in the health care sector must be routed through the central level, represented by the MoH and other ministries, notably the Ministry of Finance (MoF), which is responsible for overall fiscal policy and sectoral allocations of the annual recurrent budget. Other ministries are also involved. The Ministry of Planning and Investment (MPI) oversees capital budget allocation, whereas the Ministry of Home Affairs (MHA) manages the total number of civil servants and sectoral allocations of human resource quotas, including the annual recruitment of health personnel at all administrative levels [ 6 , 65 ].
Most respondents (19/24) highlighted the fact that in practice, the power dynamics between levels of governance are complex because constitutional power-sharing arrangements are also under political influence. Official documents support this assertion when they emphasize that in the Lao PDR, the Lao People's Revolutionary Party (LPRP) is the body that has the constitutional mandate to exercise leadership across all levels of government [ 18 , 62 ].
The Lao MoH has the ultimate responsibility for uni- and multisectoral nutrition programs. While the Provincial Health Department (PHD) and District Health Office (DHO) are responsible for implementing and ensuring the functionality of services, the central government retains control over which interventions to offer and over the allocation of human, financial, and material resources [ 66 , 69 ] (Table 3 ).
At the central level, operational leadership in the field of nutrition is formally led by the Multisectoral National Nutrition Committee (MSNNC), which comprises the Ministry of Health, Ministry of Planning and Investment, Ministry of Agriculture and Forestry, Ministry of Education and Sports, and other ministries and mass organizations. The MSNNC defines priorities, assesses local needs, and oversees the implementation of centrally sanctioned interventions at local levels (Table 3 ). Although the responsibility for the MSNNC falls under the MoH, the MSNNC is chaired by the Deputy Prime Minister and deputy chaired by the Deputy Minister of Health. Its members consist of deputy ministers of eight ministries and the vice-director or the secretary of the LPRP’s mass organizations. The MSNNC serves as the central committee overseeing the hierarchical structure of other nutrition committees at the provincial, district, and village levels. The MSNNC structure has been conceived with the idea of having leadership able to promote intersectionality of nutrition interventions [ 6 , 63 , 64 , 66 ].
Yet, under the authority of the Politburo of the LPRP, the Lao national government holds supreme authority, whereas provincial governments possess financial responsibilities and managerial duties. Provincial administration is directly supervised by the central government under the principle of democratic centralism [ 18 , 19 ].
Seven factors related to the structure and interpretative schemes that influence the effectiveness of nutrition programs emerged from the analysis of interviews and documents (Fig. 3 ).
Factors associated with the decentralization type of nutrition programs in Lao PDR
Five main structural factors emerge from the data underlying the decentralization state of nutrition programs in Lao PDR: 1) the existence of a public policy; 2) the availability of human resources; 3) the source of funding; 4) the key role of mass organizations; and 5) communication tools.
Interventions on malnutrition in Lao PDR are primarily based on a public policy, the National Nutrition Policy (NNP), which was enacted in 2008. This policy provides the legal framework for mobilizing and coordinating actors that can contribute to improving nutrition indicators, regardless of their sector. The policy is operationalized through formal strategic plans developed by the MoH. These official documents define the responsibilities of agencies addressing malnutrition among the different levels of government in the country [ 63 , 66 , 69 ]. All participants agreed that a public policy on nutrition is essential for ensuring intersectoral collaboration at various levels of governance. The policy is seen as a structural foundation that, while centralizing, guarantees the ability of the concerned players to act.
The second structuring element that emerges from the data is the fact emphasized by almost all respondents (21/24) and all documents dealing with nutrition [ 6 , 63 , 66 ] that the shortage of expertise outside the capital limits local governments from taking charge of nutrition programs more independently. The respondents also highlighted the fact that a shortage of human resources is compounded by a high turnover rate at all local levels. Turnover weakens the capacity to coordinate the numerous actors involved. Moreover, it drains a considerable part of the local budget, as it leads to continual staff training for nutrition interventions. In brief, all the participants recognized that the state of human resources made it difficult to imagine a program to combat malnutrition run by local authorities.
The health system, from the central to the village levels, is funded from three main sources: a budget allocated by the Ministry of Finance, direct payments at health facilities from users of health services, and funding from external donors, such as NGOs. Funds allocated by the central government are sent to provincial authorities, who then allocate these funds to districts according to planned budgets. These funds are designed for civil servants’ salaries as defined by the central government, as well as for the equipment needs of health establishments. Most of the money paid by service users can be kept by the hospital and used for recurrent costs, including staff wages, allowances, maintenance, utilities, and supplies. The rest (approximately 20%) should be handed over to the provincial or district finance department. Money provided by external donors for projects deployed in provinces and districts must be approved at the central level. One consequence of having multiple sources of financing nutrition activities is the variability in available funds for health services among districts and provinces [ 6 , 18 , 65 ].
The annual budget planning for nutrition interventions involves consultations and reports sent from the district to the provincial levels. The MoH then finalizes and submits it for approval by the National Assembly. In other words, nutrition programs are mainly under central government management. The majority of local-level participants (9/13) feel that this system is not optimal, the main reason being the uncertainty regarding the availability of financial resources over time. These respondents also deplore frequent delays in budget transfers, particularly transfers to remote areas. Above all, nearly all participants at the district and health center levels (6/8) mentioned that nutrition-targeted budgets are often merged with funds intended for non-nutrition public health interventions, as indicated in the following quotation.
“ There’s no other source of money. For the education or agriculture sector, the money would go to each sector separately. For these sectors, they have their own money for nutrition, but we don’t have. So, we need to depend on the integrated work. … Mainly, when we request to the central level, they said they don’t have money for our province anymore; there is only our provincial health office and their help that includes the budget, like they would include the nutrition on the integrated work, and then they manage the staff for it. The structure that divides clearly, it’s not always suitable in real situations ” said by the participant from the provincial level (P11)
The irregular flow of funds is partially offset by the availability of external funding, such as from NGOs [ 63 , 66 ]. However, activities funded by external entities require preapproval from the central government.
The fact that no respondent was able to propose solutions to the problem of funding uncertainty suggests that current funding mechanisms contribute significantly to the solidity of the structure underpinning the decentralization of nutrition programs and hence to the stability of the decentralization type that underlies nutrition programs.
In Lao PDR, the LPRP’s mass organizations, particularly Lao Women’s Union (LWU), are unavoidable collaborators in nearly all programs implemented at the population and community levels that aim to reduce the prevalence of malnutrition. Even if these organizations do not necessarily have expertise in health education which is one of their main contributions, there is a consensus among participants that they have proven to be a valuable substitute for the shortage of professionals in the field. This is expressed in the following quotation:
“…there are the LPRP grassroot members in the meeting (nutrition committee meeting at the district level), who we invited to join us, as well as the standing and district LPRP committee who divides the responsibility for guiding each population group, whoever is responsible for our target group, we would take them to the field, as well as the mass organization, especially the Lao Front for National Development as a main actor to discuss this, second is the Women Union that we can’t forget them, we would take them going to the field with us.” said by the participant from the district level (P17)
This general feeling is also recorded in several official documents [ 6 , 62 , 66 ].
In short, the constant presence of mass organizations whose primary function, in addition to contributing to health education programs, is to increase LPRP values in the population reinforces the power of the central level in nutrition programs deployed in communities.
All the participants underscore the pivotal role of social networks, such as Facebook and WhatsApp, in expediting decision-making processes that previously relied on formal communication channels and informal social gatherings. According to the participants, social media has increased the capacity of nutrition programs to reach their objectives by enabling professionals involved in nutrition programs everywhere to be easily reached and to ask questions without navigating through time consuming and poorly effective bureaucratic procedures. The participants also highlighted that these new technologies inject a sense of dynamism through the competition they foster among teams. This sentiment is captured in the following quotation:
“In the groups, there are staff (DHO staff) and department level (PHD staff) together... If the department (PHD staff) is not in the group, they will send the responsible staff to join the group. So, we always exchange (information) with each other. Whenever the central level (staff) sends messages in the group, everyone always responds. They couldn’t act like they haven’t seen it (messages) because we have the responsibilities for our work, and they also have their responsibilities. If they don’t answer, it means that they haven’t followed up (on the work)” said by the participant from the central level (P01)
There is a consensus that new communication tools have reshaped the power dynamics between central and local levels of governance in Lao PDR. They allow overpassing the traditional hierarchical structure of the healthcare system that is supported by communication channels such as those based on the exchange of information by paper (including faxes). This trend empowers lower levels to directly engage with higher-level actors at the central level, fostering a possible emerging capacity for a more decentralized dynamic inside the field of nutrition programs.
Two main interpretive factors emerged from the data underlying the decentralization state of nutrition programs in Lao PDR: 1) the understanding of the causes and consequences of malnutrition; and 2) the perception of the roles of different levels of government in implementing malnutrition interventions.
The participants across different levels of governance in Lao PDR share a common understanding of the causes and challenges of malnutrition. All the participants recognized that malnutrition is a multifaceted issue requiring attention on both the demand and supply sides. They emphasized the fact that in a resource-limited country such as Lao PDR, factors such as a lack of human and financial resources, combined with contextual challenges in vulnerable communities such as poverty, cultural barriers, and food insecurity must all be considered. Additionally, there is a consensus among participants that addressing malnutrition necessitates multisectoral programs, as programs limited to calories and micronutrients may have a limited impact on improving the condition of malnourished children. Numerous other issues, such as water, sanitation, and hygiene (WASH), gender, and the educational levels of parents, have been found to be key determinants of nutrition. They require significant collaboration from different sectors and stakeholders. In short, there is a broad consensus among stakeholders on interpretive schemes.
The majority of participants across various levels of government (10/16) spontaneously declared that interventions to address malnutrition should be led by the central government, citing the fact that the government has expertise and control over the human, financial and material resources necessary for the programs. It is also recognized that district-level health workers, particularly in remote regions, may lack sufficient training and resources. The remaining six participants did not express an opinion on this matter. Although half of the participants at the local level mentioned that regions are increasingly populated by well-trained healthcare professionals, they believe that this trend cannot have a significant impact on the power sharing arrangements for nutrition programs due to the shortage of human resources, especially in remote regions and because local health volunteers and mass organizations largely compensate for human resource needs.
Therefore, there is no question among participants regarding the state of decentralization of services that underpin nutrition programs in the country.
In brief, there is coherence between the structure and interpretive schemes that underlie the sharing of responsibilities across governance levels in nutrition programs and interventions in Lao PDR. This coherence is reinforced by the respondents' belief that the desired effects of socioeconomic changes, such as an increase in the number of well-trained nutrition professionals and the use of communication tools empowering regional health workers, cannot sufficiently alleviate human resource needs in the provinces. The system of division of responsibilities between governance levels that has lasted for approximately fifty years is therefore likely to be stable. It is likely to remain so for the foreseeable future.
In Lao PDR, powerful forces are pushing the Lao healthcare system toward more centralization than decentralization, despite factors that support greater autonomy for local authorities.
Every organization concerned with nutrition programs seems to be satisfied with this situation and perceives it as a determinant of the effectiveness of nutrition programs. None of the respondents suggested an alternative approach, despite acknowledging that socioeconomic changes are endowing regions with the capacity to manage public health programs that were previously unimaginable. Therefore, there is convergence of interpretive schemes among concerned actors, as well as coherence between structure and interpretive schemes. This convergence signifies a shared vision of nutrition challenges in the country and the capacity to address them, regardless of organizational concerns or hierarchical levels of governance. The coherence between structure and interpretive schemes reveals a general feeling that the current distribution power among governance levels is the most appropriate way to meet the nutritional needs of the population.
From an organizational perspective seen through a neoinstitutional lens [ 70 ], the main consequence is that the distribution of responsibilities in nutrition services among different government levels has remained stable since the event of the Lao PDR in 1975.
The findings of this study highlight how a country's sociopolitical context influences the state of decentralization and the functioning of its public health programs. In the case of immunization programs in Lao PDR, three notable factors impact their implementation: the Lao sociopolitical background, the availability of resources, and the use of new technologies such as WhatsApp by health professionals. These elements have reshaped the dynamics of the deconcentrated healthcare system and its program operation [ 31 ].
Theoretically, a centralized healthcare system should lead to more standardized public health programs and health services across the country if it ensures consistent application, quality of care, and equitable distribution of resources [ 71 , 72 , 73 ]. However, given the diverse contexts among provinces, a one-size-fits-all approach may not be optimal, especially for complex and multisectoral interventions like nutrition programs. These programs often require adaptation to the specific needs and capacities of local contexts and populations in different communities to be truly effective [ 74 , 75 ].
In a diverse country like Lao PDR, public health interventions require adaptation and more flexible interventions and activities to meet the varied needs of different communities. Empowering local authorities, who are more familiar with local contexts and issues, could improve the management of activities and resources, leading to better interventions that address the specific needs of their populations. In other single-party countries, decentralization has been shown to effectively strengthen public health programs and enhance their effectiveness [ 76 , 77 ].
The documents and interview findings from this study indicate that the formal structure of the healthcare system in Lao PDR is well defined. The organizational structures of the NNP identify the roles and responsibilities of stakeholders from the central level of the MoH to the implementation level of the village. However, in practice, the implemented programs aimed at reducing the prevalence of malnutrition in children under age 5 in the country are far more challenging than the formal structure suggests [ 78 ]. Addressing nutrition outcomes requires a long-term and multifaceted approach, particularly when contributions among actors and power-sharing roles involve local governments working with multiple stakeholders at all levels.
Indeed, Lao PDR faces challenges in reversing the conditions that would allow local governments to put more of their own initiatives into nutrition programs. Unlike in neighboring countries like Vietnam or Thailand, in Lao PDR, the only training on nutrition is a course integrated into a public health master’s program. Additionally, Lao PDR, a country as large as the United Kingdom with a population of 7.7 million inhabitants, is a sparsely populated country. Fifteen of its eighteen provinces have fewer than 500,000 inhabitants. Only one has more than a million [ 79 ]. A small population reduces the likelihood of building a critical mass of people from a given province with expertise in nutrition. Although constraints on qualified human resources are common in many low-resource countries [ 80 , 81 ], these constraints, coupled with the population context in Lao PDR, obviously significantly contribute to the centralization of the Lao healthcare system. In fact, this need for expertise is not limited to nutrition. Optimizing interventions to reduce the prevalence of malnutrition in children under 5 years of age requires tailored approaches that consider the diverse cultural and regional contexts of the population and address multisectoral programs and interventions including food security, water, sanitation, hygiene, maternal education, and social protection. The complexity of these interventions requires multidisciplinary teams [ 63 , 67 , 82 ]. Poorly populated provinces might not be able to gather all this desired expertise. Finally, Lao PDR receives funding for its nutrition program from several external donors and NGOs. This necessitates central-level coordination that might be even more crucial once the country has left, supposedly in 2026, the group of the least developed countries [ 83 ]. Leaving this group will have consequences for the support provided by external actors. Expectations are that the central government will assume more responsibilities for its nutrition programs in the near future.
Finally, advancements in communication technologies and the arrival of better-trained human resources offer hope for addressing the shortage of quality human resources that hinder local authorities' leadership in nutrition programs. An increasing number of graduated individuals living in the provinces are proficient in the use of new technologies [ 84 ]. This increased utilization of technology is anticipated to further transform traditional barriers that govern interactions among stakeholders. Additionally, interpretive patterns are likely to evolve as professionals in provinces become better informed and more willing to customize nutrition programs to meet the specific needs of local populations. However, owing resource shortages and uneven population distribution in Lao PDR, there are unequal opportunities for local levels to assume more responsibility for nutrition interventions, with little to no chance for decision-making at the local level. This is expected to limit the capacity of sub-national levels from contributing more substantially to nutrition programs than they currently do.
None of the respondents evoked a future where nutrition programs would be more decentralized. Nevertheless, they acknowledged that the current state of decentralization is suboptimal. They recognized that one of the undesirable effects of centralization is the difficulty in adapting services to the specific needs of diverse populations.
This study has several limitations. First, respondents were selected by their organization directors following administrative procedures mandated by research projects in Lao PDR. While this method has likely allowed to capture a diverse range of perspectives on malnutrition, it may have excluded individuals who disagreed with the official discourse. Although the two coders felt that additional interviews would not yield new information, it is possible that additional insights might have been generated by more interviews if soliciting directly potential participants directly could have been done.
Second, as is common in qualitative studies, unconscious subjectivity and bias among researchers may have influenced some interpretations. However, the risk is mitigated by ensuring the validity of four elements of the results, particularly through the triangulation of information from interviews and document reviews, as well as through independent analyses conducted by two researchers.
Finally, the generalizability of the results may be limited. The Lao context is unique, and nutrition programs have specificities that may differ from those of other national health programs functioning in the country. Consequently, the findings of this study may not be directly applicable to other programs or countries, including those with single-party governance structures.
Decentralization of the Lao healthcare system is of the deconcentrated type, i.e. a system largely under the responsibility of the central government. The transformations taking place in the healthcare system, notably with the use of new information technologies, are changing relationships between individuals across different levels of government and the fact that the provinces are populated by a growing number of professionals trained in nutrition. These factors could lead people to believe that the system would give more responsibility to provincial governments to improve their malnutrition status at local levels. However, the data show that these changes are probably not yet strong enough to change a structure that has endured for approximately fifty years. The deconcentration that characterizes decentralization is therefore likely to continue for the foreseeable future.
The datasets during and/or analyzed during the current study are available from the corresponding author upon reasonable request.
Civil society organizations
District health offices
Lao People’s Democratic Republic
Lao People's Revolutionary Party
Lao Women's Union
Ministry of Home Affairs
Multi-sectorial National Nutrition Committee
Ministry of finance
Ministry of health
Ministry of planning and investment
Nongovernmental organizations
National Nutrition Policy
National Nutrition Strategy and Plan of Action
National Plan of Action on Nutrition
Provincial health departments
United Nations
Village health volunteers
World Health Organization
World Health Organization. Malnutrition 2024. Available from: https://www.who.int/news-room/fact-sheets/detail/malnutrition .
Caulfield LE, Richard SA, Rivera JA, Musgrove P, Black RE. Stunting, wasting, and micronutrient deficiency disorders. In: Disease Control Priorities in Developing Countries 2nd edition. The International Bank for Reconstruction and Development / The World Bank. New York: Oxford University Press; 2006.
Google Scholar
Muller O, Krawinkel M. Malnutrition and health in developing countries. CMAJ. 2005;173(3):279–86.
Article PubMed PubMed Central Google Scholar
UNICEF. Child Malnutrition 2023. Available from: https://data.unicef.org/topic/nutrition/malnutrition/ .
World Health Organization, United Nations Children's Fund (UNICEF) & World Bank. Levels and trends in child malnutrition: UNICEF / WHO / The World Bank Group joint child malnutrition estimates: key findings of the 2021 edition. World Health Organization. 2021. https://iris.who.int/handle/10665/341135 .
World Health Organization. The Lao People’s Democratic Republic: Health System Review. Asia Pacific Observatory on Health Systems and Policies; 2014. Contract No.: 1.
World Bank. Lao PDR: New Financing to Improve Access to Health and Nutrition Services. 2020.
Save the Children, CARE, EU, CCL, ChildFund. Partnership for Improved Nutrition in Lao PDR Pillar 3: Sustainable Change Achieved through Linking Improved Nutrition and Governance. Vientiane: Lao Social Research; 2022.
UNICEF/WHO/World Bank Joint Child Malnutrition Estimates Expanded Database. Malnutrition data 2023. Available from: https://data.unicef.org/resources/dataset/malnutrition-data/ .
Ministry of Health, World Health Organization. Overview of Lao health system development 2009–2017. Manila, Philippines: World Health Organization Regional Office for the Western Pacific; 2018. Report No.: Licence: CC BY-NC-SA 3.0 IGO.
UNICEF/WHO/World Bank Joint Child Malnutrition Estimates Expanded Database. Malnutrition data 2022. Available from: https://data.unicef.org/resources/dataset/malnutrition-data/ .
Constantinides SV. Determinants of Nutrition Agenda Setting in the Context of the Double Burden of Malnutrition in Tamil Nadu, India. South Carolina: University of South Carolina; 2020.
Acosta AM, Fanzo J. Sussex: Institute of Development Studies; 2012.
Boko SH. Decentralization_Definitions, theories and debates. Decentralization and Reform in Africa. Boston: Sringer; 2002. p. 1–10.
Book Google Scholar
Frumence G, Nyamhanga T, Mwangu M, Hurtig AK. Challenges to the implementation of health sector decentralization in Tanzania: experiences from Kongwa district council. Glob Health Action. 2013;6:20983.
Article PubMed Google Scholar
Mosca I. Decentralization as a determinant of health care expenditure: empirical analysis for OECD countries. Appl Econ Lett. 2007;14(7):511–5.
Article Google Scholar
Saltman RB, Bankauskaite V, Vrangbaek K. Decentralization in Health Care. Maidenhead: Mcgraw-Hill House; 2007.
Martinez-Vazquez J, Gomez JL, Yao G. Fiscal Decentralization in the People’s Democratic Republic of Lao. Georgia, United States: Georgia State University; 2006. Contract No.: Working Paper 06–22.
Luangrath S. Decentralization in Lao PDR: A Case Study of the Effectiveness of Three Build Directive Policy on Local Authority. Seoul, Korea: Seoul National University; 2019.
Litvack J, Seddon J. Decentralization briefly notes. Washington, DC: World Bank Institute; 1999.
Hutchinson PL, LaFond AK. Monitoring and Evaluation of Decentralization Reforms in Developing Country Health Sectors. Maryland, United States: Abt Associates Inc.; 2004.
Stuart-Fox M. Politics and Reform in the Lao People’s Democratic Republic. Working Paper No. 126, Asia Research Center, Murdoch, University. 2005.
Pholsena V, Banomyong R. Laos: From buffer state to crossroads? Chiang Mai, Thailand: Mekong Press; 2006.
Stuart-Fox M. Political Culture and Power in the Lao People’s Democratic Republic. J Asiatic Stud. 2009;138:222–54.
United Nations in Lao PDR. Country Analysis Report: Lao PDR: Analysis to inform the Lao People’s Democratic Republic-United Nations Partnership Framework (2017–2021). Vientiane: United Nations; 2015.
Nawrot KA. Does Confucianism promote cooperation and integration in East Asia? Int Commun Chin Culture. 2020;7(1):1–30.
Jiang Y-H. Confucian political theory in contemporary China. Annu Rev Polit Sci. 2018;21:155–73.
Kim Y, Lee H-K, Park S. The Confucian Tradition and Politics. Oxford Research Encyclopedia of Politics. 2019.
Dickovick JT. Foreign aid and decentralization: Policies for autonomy and programming for responsiveness. Helsinki: The United Nations University World Institute for Development Economics Research (UNU-WIDER); 2013.
Dickovick JT. Foreign aid and decentralization: limitations on impact in autonomy and responsiveness. Public Admin Dev. 2014;34(3):194–206.
Viphonephom P, Kounnavong S, Reinharz D. Decentralization and immunization program in a single-party state: the case of the Lao People’s Democratic Republic. Trop Med Health. 2024;52(1):35.
Meyer JW, Rowan B. Institutionalized organizations: formal structure as myth and ceremony. Am J Sociol. 1977;83(2):340–63.
DiMaggio PJ, Powell WW. The iron cage revisited: institutional isomorphism and collective rationality in organizational fields. Am Sociol Rev. 1983;48(2):147–60.
Marschlich S. Conceptual Framework: Sociological Neo-Institutionalism, Legitimacy, and Public Relations. Corporate Diplomacy: How Multinational Corporations Gain Organizational Legitimacy: A Neo-Institutional Public Relations Perspective. Amsterdam: University of Amsterdam; 2022.
Swaminathan A, Wade JB. Institutional Environment. The Palgrave Encyclopedia of Strategic Management. London: Palgrave Macmillan; 2016. p. 1–7.
Hinings CR, Royston G. The Dynamics of Strategic Change. Oxford: Basil Blackwell Ltd.; 1988.
Hinings CR, Greenwood R, Reay T, Suddaby R. Dynamics of change in Organizational field. Handbook of Organizational Change and Innovation: Oxford University Press; 2003.
Harimanana A, Barennes H, Reinharz D. Organizational analysis of maternal mortality reduction programs in Madagascar. Int J Health Plann Manage. 2011;26(3):e186–96.
Peyrot M. Institutional and organizational dynamics in community-based drug abuse treatment. Soc Probl. 1991;38(1):20–33.
Morrill C, Yalda C, Adelman M, Musheno M, Bejarano C. Telling tales in school- youth culture and conflict narratives. Law Soc Rev. 2000;34(3):521–65.
Addicott R, Furlie E. Sedimented archetype change in public sector organisations: the example of managed clinical networks for cancer. CQUniversity. Conference contribution. 2006. https://hdl.handle.net/10018/8418 .
Breunig KJ, Skjølsvik T. The virtual future of professional service firms: Identifying emerging interpretive schemes caused by technology enactment. Acad Manag Proc. 2016. https://hdl.handle.net/10642/4407 .
Greenwood R, Hinings CR. Understanding radical organizational change: Bringing together the old and the new institutionalism. Acad Manag Rev. 1996;21(4):1022–54.
Senge K. The ‘New Institutionalism’ in organization theory: Bringing society and culture back in. Am Sociol. 2013;44(1):76–95.
Scott WR. Institutions and organizations : ideas, interests and identities. 4th ed. Thousand Oaks: SAGE Publications, Inc.; 2013.
Rouleau L. Théories des organisations : Approches calssiques, contemporaines et de l’avant-garde. Quebec, Canada: Presse de Université du Québec; 2007.
Creswell JW. Research Design: Qualitative, Quantitative, and Mixed Methods Approaches. London, United Kingdom: SAGE Publications Inc; 2013.
Huby G, Hart E, McKevitt C, Sobo E. Addressing the complexity of health care: The practical potential of ethnography. J Health Serv Res Policy. 2007;12(4):193–4.
Kielmann K. The ethnographic lens. In: Gilson L, editor. Health policy and systems research: A methodology reader. Geneva, Switzerland: World Health Organization; 2012. p. 235–52.
Lao Statistic Bureau. Lao PDR: Lao Social Indicator Survey 2011–2012 (Multiple Indicator Cluster Survey/Demographic and Health Survey). Vientiane: Lao Statistic Bureau and UNICEF; 2012.
Lao Statistic Bureau. Lao Social Indicator Survey II 2017. Vientiane: Lao Statistic Bureau and UNICEF; 2018.
Pope C. Qualitative Research in Health Care. Hoboken: Wiley-Blackwell; 2020. p. 2020.
Creswell JW, Plano Clark VL. Designing and Conducting Mixed Methods Research. 2nd ed. Los Angeles: Sage Publications; 2011.
Palinkas AP, Horwitz SM, Green CA, Wisdom JP, Duan N, Hoagwood K. Purposeful sampling for qualitative data collection and analysis in mixed method implementation research. Adm Policy Ment Health. 2015;42(5):533–44.
Naderifar M, Goli H, Ghaljaie F. Snowball sampling: a purposeful method of sampling in qualitative research. Strides Dev Med Educ. 2017;14(3):1–4.
Fortin M-F, Gagnon J. Fondements et étapes du processus de recherche: Méthodes quantitatives et qualitatives. 3rd ed. Montreal: Chenelière éducation; 2016.
Park D, Bahrudin FI, Han J. Circular reasoning for the evolution of research through a strategic construction of research methodologies. Int J Quant Qual Res Methods. 2020;8(3):1–23.
CAS Google Scholar
Proudfoot K. Inductive/Deductive Hybrid Thematic Analysis in Mixed Methods Research. J Mixed Methods Res. 2022;0(0):1–19.
Ponterotto JG. Brief note on the origins, evolution, and meaning of the qualitative research concept “Thick Description.” Qual Rep. 2006;11(3):538–49.
Kharel D. VIsual enthnography, thick description and cultural representation. Dhaulagiri J Sociol Anthropol. 2015;9:147–60.
Korstjens I, Moser A. Series: Practical guidance to qualitative research. Part 4: Trustworthiness and publishing. Eur J Gen Pract. 2018;24(1):120–4.
Dahuai Y, Phoutthaphone S, Jing W. The role of Marxism in the Lao political system in the contemporary era. Int J Soc Sci Human Invent. 2017;4(12):4216–26.
Ministry of Health. National Plan of Action on Nutrition (NPAN) 2021–2025. Vientiane: Ministry of Health; 2021.
Lao PDR National Immunization Programme. Updated Comprehensive Multi-Year Plan Lao PDR 2019–2023. Vientiane: Ministry of Health, GAVI, UNICEF/WHO; 2018.
World Bank. Government spending on health in Lao PDR: Evidence and issues. Vientiane: World Bank; 2012.
Ministry of Health. National Nutrition strategies to 2025 and Plan of Action 2016–2020. Vientiane: Ministry of Health; 2015.
Secretariat National Nutrition Committee. Operational guideline for the implementation of the National Plan of Action on Nutrition (NPAN) 2021 to 2025. Vientiane: National Nutrition Committee Secretariat; 2023.
Bureau PM. Prime Minister’s Decree No. 570 on the organization and activities of the Ministry of Health. Vientiane; 2021.
Ministry of Health. National Nutrition Policy. Vientiane: Ministry of Health; 2008.
Greenwood R, Hinings CRB. Radical organizational change. SAGE Publications Ltd. 2006.
Ostermann M, Vincent J-L. How much centralization of critical care services in the era of telemedicine? Crit Care. 2019;23(1):423.
Kobayashi D, Otsubo T, Imanaka Y. The effect of centralization of health care services on travel time and its equality. Health Policy. 2015;119(3):298–306.
Elson S. Regionalization of health care from a political and structural perspective. Healthc Manage Forum. 2009;22(1):6–11. https://doi.org/10.1016/S0840-4704(10)60279-7 .
Sanders D, Chopra M. Implementing comprehensive and decentralised health systems: the quest for integrated care in post-apartheid South Africa. Int J Integr Care. 2001;1:e33.
Kesale AM, Mahonge C, Muhanga M. Effects of decentralization on the functionality of health facility governing committees in lower and middle-income countries: a systematic literature review. Glob Health Action. 2022;15(1):2074662.
Zhu J, Ge Z, Xia J, Liu Q, Ran Q, Yang Y. Status quo and problem analysis of cervical cancer screening program in China: Based on RE-AIM framework. Front Public Health. 2022;10:987787. https://doi.org/10.3389/fpubh.2022.987787 .
Huang X, Yang B, Liu Q, Zhang R, Tang S, Story M. Improving maternal and child nutrition in China: an analysis of nutrition policies and programs initiated during the 2000–2015 Millennium Development Goals era and implications for achieving the Sustainable Development Goals. J Health Popul Nutr. 2020;39(1):12.
Sengchaleun V, Samri MA, Kounnavong S, Reinharz D. Advocacy Coalition by External Actors and Strategies Used to Influence the Emergence of the National Nutrition Policy in Lao PDR. Health. 2021;13(08):812–29.
World Health Organization. World Health Organization Data 2020. Available from: https://data.who.int/countries .
Delisle H, Shrimpton R, Blaney S, Du Plessis L, Atwood S, Sanders D, et al. Capacity-building for a strong public health nutrition workforce in low-resource countries. Bull World Health Organanization. 2017;95(5):385–8.
Diasso D, Doudou MH, Levrak MC, Sedutto HD, Savadogo A. Municipalities’ organisational capacity to support the implementation of the Multi-Sector Nutrition Plan in Burkina Faso. Glob Health Action. 2021;14(1):1979279.
European Union, UNICEF. Review of costing of the National Plan of Action for Nutrition 2016–2020. Vientiane: European Union and UNICEF; 2020.
Ministry of Foreign Affairs. Lao PDR is recommended to graduate in 2026 from the Least Developed Country Category with an extended preparatory period. Vientiane, Lao PDR: Ministry of Foreign Affairs 2021. Available from: http://www.mofa.gov.la/index.php/activities/state-leaders/3999-lao-pdr-is-recommended-to-graduate-in-2026-from-the-least-developed-country-category-with-an-extended-preparatory-period .
World Bank. Positioning The Lao PDR for a Digital Future. Vientiane: World Bank; 2021.
Download references
We would like to express our sincere thanks to all the participants who generously shared their valuable experiences with us. We would also like to express our thanks to the organizations that assisted us in participant recruitment. The first author P.V. extends her special thanks to the Canadian Francophonie Scholarship Program (CFSP) for their support during her doctoral studies.
This research was supported by the Canadian Francophonie Scholarship Program, under the Canadian Bureau for International Education, Government of Canada.
Authors and affiliations.
Department of Social and Preventive Medicine, Laval University, Quebec City, QC, Canada
Phonevilay Viphonephom & Daniel Reinharz
Lao Tropical and Public Health Institute (Lao TPHI, Ministry of Health, Vientiane, Lao PDR
Sengchanh Kounnavong
You can also search for this author in PubMed Google Scholar
PV: conceptualization and design; acquisition of data; analysis and interpretation of data; writing original draft; and writing review and editing of the manuscript. SK: recruitment of participants; writing review and editing the manuscript; and supervision. DR: conceptualization and design; analysis and interpretation of data; writing review and editing of the manuscript and supervision. All authors have read and approved the final manuscript.
Correspondence to Phonevilay Viphonephom .
Ethics approval and consent to participate.
All methods were carried out in accordance with relevant guidelines and regulations. Written consent was obtained from all participants before data collection. Ethical approval for the study was obtained from the Research Ethics Board of Laval University, Quebec, Canada (number “2021–259/23–09-2021”) and the National Ethics Committee for Health Research, Ministry of Health, Vientiane, Lao PDR (number “08/NECHR”, 14/01/2022).
Not applicable.
The authors declare no competing interests.
Publisher’s note.
Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ .
Reprints and permissions
Cite this article.
Viphonephom, P., Kounnavong, S. & Reinharz, D. The state of decentralization of the healthcare system and nutrition programs in the Lao People’s Democratic Republic: an organizational study. BMC Health Serv Res 24 , 1037 (2024). https://doi.org/10.1186/s12913-024-11513-y
Download citation
Received : 04 October 2023
Accepted : 29 August 2024
Published : 06 September 2024
DOI : https://doi.org/10.1186/s12913-024-11513-y
Anyone you share the following link with will be able to read this content:
Sorry, a shareable link is not currently available for this article.
Provided by the Springer Nature SharedIt content-sharing initiative
ISSN: 1472-6963
Intended for healthcare professionals
Linked research.
Measures of how well a vaccine works
Objective To estimate the real world effectiveness of modified vaccinia Ankara-Bavarian Nordic (MVA-BN) vaccine against mpox infection.
Design Emulation of a target trial.
Setting Linked databases in Ontario, Canada.
Participants 9803 men aged ≥18 years with a history of being tested for syphilis and a laboratory confirmed bacterial sexually transmitted infection (STI) in the previous year, or who filled a prescription for HIV pre-exposure prophylaxis in the previous year. On each day between 12 June 2022 and 27 October 2022, those who had been vaccinated 15 days previously were matched 1:1 with unvaccinated men by age, geographical region, past HIV diagnosis, number of bacterial STI diagnoses in the previous three years, and receipt of any non-MVA-BN vaccine in the previous year.
Main outcome measure The main outcome measure was vaccine effectiveness ((1–hazard ratio)×100) of one dose of subcutaneously administered MVA-BN against laboratory confirmed mpox infection. A Cox proportional hazards model was used to estimate hazard ratios to compare the rate of laboratory confirmed mpox between the two groups.
Results 3204 men who received the vaccine were matched to 3204 unvaccinated controls. A total of 71 mpox infections were diagnosed, with 0.09 per 1000 person days (95% confidence interval (CI) 0.05 to 0.13) in the vaccinated group and 0.20 per 1000 person days (0.15 to 0.27) in the unvaccinated group over the study period of 153 days. Estimated vaccine effectiveness of one dose of MVA-BN against mpox infection was 58% (95% CI 31% to 75%).
Conclusion The findings of this study, conducted in the context of a targeted vaccination programme and evolving outbreak of mpox, suggest that one dose of MVA-BN is moderately effective in preventing mpox infection.
In May 2022, more than 20 countries where mpox had not been previously identified reported infections to the World Health Organization. 1 On 23 July 2022, the global mpox outbreak was declared a public health emergency of international concern, and targeted use of second or third generation smallpox vaccines was recommended for control of the outbreak. 2
Modified vaccinia Ankara-Bavarian Nordic (MVA-BN) vaccine (trade names Imvamune, Jynneos, and Imvanex) is a third generation, live attenuated, non-replicating vaccine against smallpox. 3 In Ontario, Canada, MVA-BN was introduced in June 2022 as post-exposure prophylaxis for high risk contacts (but few doses were given in this context) and pre-exposure prophylaxis for gay, bisexual, and other men who have sex with men, and sex workers at high risk of exposure to mpox. 4 Although MVA-BN is approved in Canada as a series of two doses 28 days apart, Ontario initially employed a dose sparing strategy such that vaccine candidates could only receive one dose owing to concerns about limited vaccine supply. A two dose (0.5 mL each, subcutaneously) programme was subsequently implemented on 30 September 2022.
Before the global mpox outbreak, clinical or real world data on the use of MVA-BN to prevent mpox infection were limited. 5 6 Estimates of the effectiveness of a single dose of MVA-BN obtained using various observational study designs have since emerged in the literature, ranging from 36% to 86%. 7 8 9 10 11 12 13 14 15 As with all observational studies, each report discussed the potential for residual confounding and selection biases. Only one study to date emulated a target trial to address these biases, but it was restricted to HIV negative men who had used HIV pre-exposure prophylaxis. 10 In the current study we estimated the vaccine effectiveness of one dose of MVA-BN against laboratory confirmed mpox infection in a broader population through a target trial emulation to reduce biases.
We conducted a target trial emulation to answer the causal question of interest (see supplementary figure S1 and table S1) and to reduce biases, particularly from confounding. 16 Laboratory, vaccination, reportable diseases, and health administrative data were used from Ontario (population 15.1 million as of July 2022), which has a single payer healthcare system. All datasets included in the analysis (see supplementary methods) were linked using unique encoded identifiers and analysed at ICES.
The study period captured the beginning of the availability of pre-exposure vaccination (12 June 2022 to 26 November 2022, during which time mpox was diagnosed in 691 people in Ontario; fig 1 , also see supplementary table S2 for Ontario surveillance definitions of mpox). 17 The end date was chosen based on several indicators, including weekly percentage positivity <5% and the last individual with outbreak associated mpox reported on 10 November 2022. 18 Eligibility for single dose, pre-exposure vaccination comprised gay, bisexual, and other men who have sex with men reporting one or more of a diagnosis of bacterial sexually transmitted infection (STI) in the previous two months; currently engaging in or anticipating sex with two or more sexual partners; attending sex-on-premises venues; or engaging in anonymous sex. Eligibility for pre-exposure vaccination also included individuals engaged in sex work, immunocompromised individuals, or pregnant individuals if they were contacts of people at risk, as defined above. 19
Confirmed mpox infections and number of MVA-BN vaccine doses administered by week in Ontario, Canada, 1 May to 25 December 2022. MVA-BN= modified vaccinia Ankara-Bavarian Nordic
Because the administrative data do not include information on each of the specific criteria laid out by Ontario’s MVA-BN vaccine programme, we used proxies for potential sexual exposure to mpox to define our eligible population for the trial specification. That is, if a randomised control trial were to be possible but was restricted to using variables available in the health administrative data, our approach to target trial specification would make use of these variables as proxies for sexual activity (see supplementary table S1). Eligibility criteria for the target trial were conceptualised to reduce confounding between vaccination status and risk of subsequent infection. The study population was restricted to men aged ≥18 years as of 12 June 2022 with at least one of the following proxies for risk of exposure to mpox as of the date of matching (ie, time zero, which could occur between 12 June 2022 and 27 October 2022, to ensure each person could have at least 30 days of observation): at least one syphilis test in the previous year and a new diagnosis of one bacterial STI or more (chlamydia, gonorrhoea, or syphilis) in the year before matching; or a filled prescription for HIV pre-exposure prophylaxis in the year before matching (see supplementary table S3 for definitions). We excluded individuals with a documented positive polymerase chain reaction test result for mpox before 12 June 2022.
The intervention of interest was vaccination with a single dose of MVA-BN. We were unable to estimate the effectiveness of a second dose because only a few individuals had received such a dose (13.7% of those who received one dose) by the end of the study period (26 November 2022) and few people received an mpox diagnosis in October and November. The outcome of interest was polymerase chain reaction confirmed mpox infection, based on the specimen collection date. Based on immunogenicity data, an individual was classified as vaccinated >14 days after the first dose. 20
On each day between 12 June 2022 and 27 October 2022, men who had been vaccinated with a single dose of MVA-BN 15 days previously were matched in a 1:1 ratio to unvaccinated controls. We followed individuals until the earliest date of any of the following events: outcome, death, 15 days after receipt of a first vaccine dose (for unvaccinated controls), 15 days after receipt of a second dose, or end of the study period. Individuals who initially contributed observation time as an unvaccinated control were censored (along with their matched vaccinated individual) 15 days after receipt of MVA-BN and were re-matched as a vaccinated individual with a new unvaccinated control (see supplementary table S1). 21
To balance the distribution of measured baseline covariates that are associated with the probability of vaccination and mpox infection between vaccine recipients and controls, we matched vaccine recipients and controls on age (within five years), geographical region (since the epidemic trajectory and vaccine uptake varied regionally), proxies for sexual exposures (number of bacterial STIs in the previous three years, HIV status), and a proxy for vaccine confidence (receipt of any non-MVA-BN vaccine in the previous year). These covariates were defined using 12 June 2022. The supplementary methods section provides details of the matching algorithm. For vaccinated individuals, time zero was 15 days after vaccination, whereas unvaccinated controls inherited the time zero of the vaccinated person to whom they were matched.
We conducted three sensitivity analyses. To explore the potential for residual confounding by risk of sexual exposures, we used two negative control outcomes that should not be directly affected by the receipt of MVA-BN but for which the effect of vaccination might be confounded. 22 Firstly, we measured the risk of mpox during the first 14 days after the first dose, when no difference between vaccinated and unvaccinated groups would be expected (the negative outcome period). Secondly, we used a negative tracer outcome by estimating vaccine effectiveness against bacterial STI >14 days after vaccination; MVA-BN vaccine presumably has no benefit against infection with chlamydia, gonorrhoea, or syphilis. However, an STI diagnosis could be influenced by differential rates of testing after vaccination. Thus we compared syphilis testing among vaccinated and unvaccinated groups over the study period to aid interpretation of the negative tracer outcome. Finally, we examined the potential for residual confounding related to socioeconomic status by adjusting for income at neighbourhood level, given that sexual networks and infection risks are shaped by systemic barriers to engagement in healthcare and access to vaccines.
We examined covariate balance after matching using standardised mean differences, and considered a difference of ≥0.1 as potentially clinically meaningful. 23 Cumulative incidence functions were estimated for the vaccinated and unvaccinated groups and we used a Cox proportional hazards model to estimate the hazard ratio comparing the hazard of mpox between the two groups, using a robust variance estimator to account for the matched design. 24 We calculated vaccine effectiveness as ((1–hazard ratio)×100). Analyses were performed using SAS software version 9.4 (SAS Institute, Cary, NC).
This work was undertaken in response to questions about the effectiveness of MVA-BN by public health, clinical, and community members. Participants were not involved in the original design of this study. We shared study results with diverse community representatives interested in the mpox response.
A total of 9803 men aged ≥18 years were eligible for the study, of whom 272 received a diagnosis of mpox during the study period, including 15 who required hospital admission with mpox. A total of 3204 men who received the vaccine were matched to 3204 unvaccinated controls ( fig 2 ). The matched population was similar to the eligible population for baseline characteristics (see supplementary table S4). All measured variables were well balanced between the vaccinated and unvaccinated groups ( table 1 ). The median age of matched participants was 35 years (interquartile range (IQR) 29-46 years) and more than half of the participants (66.1%) were residents of Toronto.
Cohort enrolment process and selection of individuals for emulation of a target trial evaluating effectiveness of the modified vaccinia Ankara-Bavarian Nordic. OHIP=Ontario Health Insurance Plan; STI=sexually transmitted infection
Personal and sexual risk characteristics of the study population for the target trial emulation design. Values are number (percentage) unless stated otherwise
During a median follow-up of 85 days (IQR 32-110 days) after the first dose among vaccinated individuals and 86 (31-111) days among unvaccinated individuals, we observed a total of 71 infections, with 21 in the vaccinated group (0.09 per 1000 person days, 95% confidence interval (CI) 0.05 to 0.13) and 50 in the unvaccinated group (0.20 per 1000 person days, 0.15 to 0.27) over the study period of 153 days. We censored 293 (9.1%) individuals owing to receipt of a second dose. Figure 3 shows the cumulative incidence functions for the vaccinated and unvaccinated groups during the study period. The hazard ratio for infection in the vaccinated group compared with unvaccinated group was 0.42 (95% CI 0.25 to 0.69), thus the estimated vaccine effectiveness for a single dose of MVA-BN against mpox infection was 58% (95% CI 31% to 75%; fig 4 ).
Cumulative incidence functions of confirmed mpox infection in Ontario, Canada, 12 June 2022 to 26 November 2022. Shaded areas represent 95% confidence intervals. *Estimates that could lead to back calculation of small cells have been shown with a range of values instead of the exact value
Estimates of vaccine effectiveness of one dose of MVA-BN between 12 June 2022 and 26 November 2022 in Ontario, Canada, primary and sensitivity analyses. MVA-BN=modified vaccinia Ankara-Bavarian Nordic; STI=sexually transmitted infection
Examination for residual confounding using negative outcomes showed a vaccine effectiveness of –15% (–92% to 31%) during the first 14 days post-vaccination, and vaccine effectiveness of –89% (–125% to –58%) against bacterial STI (see cumulative incidence functions in supplementary figure S2). Rates of a first syphilis test post-vaccination were 0.05 per 1000 person days in the vaccinated group and 0.03 per 1000 person days in the unvaccinated group. Finally, we did not identify a meaningful change in vaccine effectiveness against mpox infection after additionally adjusting for neighbourhood level income (vaccine effectiveness 60%, 34% to 76%).
Using a target trial emulation, we estimated the effectiveness of a single dose of MVA-BN vaccine to be moderate (58%, 31% to 75%) for preventing mpox infection in the context of a targeted vaccination programme in Ontario, Canada. To confirm the specificity of this association, we determined that MVA-BN was not associated with a reduced rate of mpox infection during the first 14 days post-vaccination (before developing an adequate antibody response) nor bacterial STI diagnoses (against which no protection would be expected).
Our estimate of vaccine effectiveness falls within the range observed across previous studies conducted in jurisdictions with similar epidemic dynamics and targeted vaccination programmes. Our findings are most consistent with studies that restricted the study population to those at greatest risk of exposure to mpox and that reduced time based and risk based confounding. 8 10 11 14 15 In the Canadian province of Quebec, a test negative study that used health administrative data and adjusted for exposure risks based on similar proxies as in our study (ie, previous bacterial STI), estimated vaccine effectiveness against mpox infection to be 35% (95% CI 2% to 59%). 14 After further adjusting for self-reported measures of exposure risks (restricting analyses to those who completed a detailed questionnaire), vaccine effectiveness was estimated to be 65% (1% to 87%), similar to our estimate. Our estimate is lower than (but still compatible with) an estimate of 86% (95% CI 59% to 95%) from a retrospective cohort study in Israel that used more restrictive study eligibility criteria (ie, living with HIV and a recent diagnosis of bacterial STI, or receipt of HIV pre-exposure prophylaxis), 8 and an estimate of 79% (95% CI 33% to 100%) from a target trial emulation conducted in Spain with even more restrictive study eligibility (ie, enrolment restricted to men receiving HIV pre-exposure prophylaxis). 10
Our study has several strengths. Firstly, we used linked population based databases within a publicly funded healthcare system to identify all MVA-BN vaccination events and all mpox related laboratory tests in Ontario. Secondly, to address the risks of residual confounding present in any observational study, we conducted rigorous matching across key potential confounders of the causal effect of vaccination on mpox infection. Risk confounding is particularly important when estimating vaccine effectiveness because Ontario, like other jurisdictions, specifically targeted vaccination to individuals at greatest risk of infection. Evidence of exchangeability includes the similarity between groups for proxies of sexual exposure risks, and similar outcomes during the negative control period before the vaccine was expected to confer protection. We examined this negative control period based on immunogenicity data, recognising that some protection may have been conferred in the first 14 days, if the dose was administered deliberately or inadvertently within the window for post-exposure prophylaxis. 25 26 The negative tracer outcome analysis involving bacterial STI suggests that the observed vaccine effect is unlikely to be explained by differential reductions in sexual activity among gay, bisexual, and other men who have sex with men over the study period. In contrast, our finding of higher rates of newly diagnosed bacterial STIs among vaccinated men suggests that the vaccination programme successfully reached those most at risk of mpox and/or vaccinated men engaged in increased sexual activity post-vaccination. This means that vaccinated individuals may have engaged in more sexual activity than their unvaccinated counterparts after vaccination. Indeed, given the focus of vaccine campaign messaging on preventing future exposure risks, individual decisions about the vaccine could be shaped by anticipating future sexual partnerships, irrespective of the past. The higher rates of bacterial STIs post-vaccination could also stem from additional STI testing opportunities and detection after engagement in preventive care with vaccination, as evidenced by higher syphilis testing rates during the post-vaccination period. However, the negative tracer findings suggest that residual confounding could be present due to differential increases in sexual activity, and thus our estimate of vaccine effectiveness may be underestimated. Finally, the study period included a rapidly evolving outbreak, with risks of exposure to mpox declining quickly before a large fraction of the study eligible population was vaccinated, thus the risk for time varying confounding due to differential exposure risks was substantial, which we reduced by emulating a target trial.
Our study also has limitations. Firstly, the rigorous matching meant that our final cohort comprised only 65% of the eligible population, with 71 outcomes for analysis. Thus, the final cohort comprised 8.8% of the 36 312 first dose vaccinations and 10% of all mpox diagnoses in Ontario during the study period. Although the characteristics of included and eligible participants were similar, a reduction in confounding came at the price of decreased sample size and precision. It also meant that subgroup analyses, such as among individuals aged >50 years, who may have received earlier generation smallpox vaccines, were not possible. Secondly, we were limited to routinely collected data, and information on previous smallpox vaccination, sexual exposures, and individual level measures of social determinants of health were not available. Information on neighbourhood level income was available but was not used for matching to limit further loss of sample size, and because area level median income may not capture the ways in which individual level income, or other individual level social determinants, might influence sexual networks. 27 Furthermore, comparison across groups and the third sensitivity analysis suggested no residual confounding by neighbourhood level income. Thirdly, although we included men with a history of bacterial STIs, our study eligibility population could be missing men who are at risk of mpox infection but have negligible access to healthcare and/or healthcare engagement (thus leading to a selection bias). Fourthly, although data from other studies showed added protective benefit of two vaccine doses, 9 11 12 we could not evaluate the two dose regimen because of low second dose coverage during the study period, nor could we evaluate duration of protection. Finally, vaccination could also reduce symptoms and signs of mpox and thus result in less testing, 28 which would mean a higher chance of under-ascertainment of people with subclinical infection among the vaccinated group, which would lead to overestimation of vaccine effectiveness against infection.
Vaccination with a single dose of MVA-BN vaccine was found to be moderately effective against laboratory confirmed mpox infection in this population based study of an evolving outbreak and using a target trial emulation to reduce biases. One implication of our finding is that single dose vaccination may have been a contributing factor in helping to slow transmission in Ontario in 2022. Mpox infections in Canada and across the globe are rising again in 2024, with most diagnoses among individuals who have not yet been vaccinated or have received only a single dose of vaccine. 29 30 Given the moderate effectiveness of a single dose, achieving high coverage with a full course could be important to prevent and manage ongoing transmission globally and prevent a large resurgence. 31 32 In the absence of randomised clinical trials, our findings strengthen the evidence that MVA-BN is effective at preventing mpox infection and should be made available and accessible to communities at risk.
No randomised clinical trials of vaccination against mpox have been conducted
Estimates of vaccine effectiveness of a single dose of vaccination range from 36% to 86%, but these observational designs noted residual confounding as a major concern given vaccine implementation was appropriately prioritised to individuals most at risk of infection
Estimates of vaccine effectiveness, using approaches to minimise biases, are needed
In an emulated target trial to reduce biases, the effectiveness of a single dose of modified vaccinia Ankara-Bavarian Nordic (MVA-BN) vaccine against mpox infection was 58% (95% confidence interval 31% to 75%)—a finding that was robust to further sensitivity analysis for residual confounding
In the absence of data from randomised controlled trials, the study findings strengthen the evidence that MVA-BN is effective at preventing mpox infection and should be made available and accessible to communities at risk
Ethical approval.
ICES is a prescribed entity under Ontario’s Personal Health Information Protection Act (PHIPA). Section 45 of PHIPA authorises ICES to collect personal health information, without consent, for the purpose of analysis or compiling statistical information with respect to the management of, evaluation or monitoring of, the allocation of resources to or planning for all or part of the health system. Projects that use data collected by ICES under section 45 of PHIPA, and use no other data, are exempt from REB review. The use of the data in this project is authorised under section 45 and approved by ICES’ Privacy and Legal Office. Ethical approval for this study was obtained from Public Health Ontario’s Ethics Review Board.
The dataset from this study is held securely in coded form at ICES. While legal data sharing agreements between ICES and data providers (eg, healthcare organisations and government) prohibit ICES from making the dataset publicly available, access may be granted to those who meet prespecified criteria for confidential access, available at https://www.ices.on.ca/DAS (email [email protected] ). The full dataset creation plan and underlying analytical code are available from the authors upon request, understanding that the computer programs may rely upon coding templates or macros that are unique to ICES and are therefore either inaccessible or may require modification. Correspondence and requests for materials should be addressed to JCK or SM.
We acknowledge colleagues at Public Health Ontario for access to vaccination data from the Digital Health Information Repository, case level data from the integrated Public Health Information System, and laboratory data from LabWare. We also thank the staff of Ontario’s public health units who are responsible for mpox case and contact management and data collection. We acknowledge the work of more than 30 community based organisations across Ontario who led vaccine mobilisation and implementation with public health units and healthcare providers. This document used data adapted from the Statistics Canada Postal Code Conversion File, which is based on data licensed from Canada Post Corporation, and/or data adapted from the Ontario Ministry of Health Postal Code Conversion File, which contains data copied under license from Canada Post Corporation and Statistics Canada. Parts of this material are based on data and/or information compiled and provided by the Ontario Ministry of Health, Canadian Institute for Health Information, Statistics Canada, and IQVIA Solutions Canada. The analyses, conclusions, opinions, and statements expressed herein are solely those of the authors and do not reflect those of the funding or data sources; no endorsement is intended or should be inferred. Adapted from Statistics Canada, Canadian Census 2016. This does not constitute an endorsement by Statistics Canada of this product. We thank IQVIA Solutions Canada for use of their Drug Information File. Finally, we thank Nicholas Brousseau and Sara Carazo Perez, Institut national de santé publique du Québec, for helpful discussions about methodological approaches and confounders.
Contributors: JCK and SM designed the study and analysis plan and are joint senior authors with equal contribution. SAB, CN, JCK, and LF acquired the data for the work. CL designed the data extraction and assembly workflow. CL analysed the data. All authors made substantial contributions to the analysis plan and the interpretation of the data. JCK and SM vouch for the data analysis. CN, SM, and JCK wrote the first draft of the manuscript. All authors critically reviewed the manuscript and decided to proceed with publication. SM and JCK are responsible for the overall content as guarantors and accept full responsibility for the work and conduct of the study and had access to the data and controlled the decision to publish. The corresponding authors attest that all listed authors meet authorship criteria and that no others meeting the criteria have been omitted.
Funding: This study was supported by ICES, which is funded by an annual grant from the Ontario Ministry of Health and the Ministry of Long-Term Care. This study also received funding from the Canadian Immunization Research Network through a grant from the Public Health Agency of Canada and the Canadian Institutes of Health Research (CNF 151944). The Canada-Africa Mpox Partnership, of which this study is one component, was also supported by the Canadian Institutes of Health Research Rapid Mpox Research (MRR-184812). The opinions, results, and conclusions reported in this paper are those of the authors and are independent from the funding sources. Funders had no role in the design or conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication. JCK is supported by a clinician-scientist award and ANB is supported by a non-clinician scientist award from the University of Toronto Department of Family and Community Medicine. SM, DT, and ANB are supported by Tier 2 Canada Research Chairs.
Competing interests: All authors have completed the ICMJE uniform disclosure form at https://www.icmje.org/disclosure-of-interest/ and declare: support from ICES and the Canadian Immunization Research Network; no support from any organisation for the submitted work; no financial relationships with any organisations that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have influenced the submitted work.
Transparency: The corresponding author (the manuscript’s guarantor) affirms that the manuscript is an honest, accurate, and transparent account of the study being reported; that no important aspects of the study have been omitted; and that any discrepancies from the study as planned (and, if relevant, registered) have been explained.
Dissemination to participants and related patient and public communities: Preliminary results of this study have been made available to the public on a preprint server and have been shared with the Ministry of Health and ICES. After peer review publication, they will be further disseminated by ICES through news media and social media. It is not possible to send study results to participants because all personal identifying information has been removed from the dataset.
Provenance and peer review: Not commissioned; externally peer reviewed.
This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ .
Thank you for visiting nature.com. You are using a browser version with limited support for CSS. To obtain the best experience, we recommend you use a more up to date browser (or turn off compatibility mode in Internet Explorer). In the meantime, to ensure continued support, we are displaying the site without styles and JavaScript.
Restorative dentistry
Evidence-Based Dentistry ( 2024 ) Cite this article
12 Accesses
Metrics details
A prospective, randomized, split-mouth clinical study by the two previously trained and calibrated pediatric dentists without blinding operators and patients due to different protocols in both treatment groups. An SDF + potassium iodide (KI) and SDF + KI + glass ionmer cement (GIC) on International Caries Detection and Assessment System (ICDAS) 1/2 molar was received by each patient on either side of mouth. The local Ethics Committee approved this study.
Sample size calculation was not performed due to the lack of published studies on the longevity of SMART sealant on MIH-affected molars and the absence of research on the apparent difference between the effectiveness of SMART and SDF treatments in preventing further caries and sensitivity.
These were children between the ages of 6 years to 13 years, who visited the Pediatric Dentistry Clinic at XX University School of Dentistry for routine exams and treatment between July 2019 to May 2020. They were in good health and had at least two fully erupted permanent first molars with MIH as per the European Academy of Pediatric Dentistry, ICDAS code 1/2. This study recorded 12 months of treatment outcomes on hypomineralised molars of 48 children with a follow-up of three years. Children were excluded with specific syndromes associated with enamel malformation, lack of cooperation, ongoing orthodontic treatment, and teeth with ICDAS 3/4/5/6 lesions, existing restorations, fluorosis, or pulpal symptoms.
Mann-Whitney U Test was used to assess differences between independent groups (SDF and SMART) and the Friedman Test between dependent groups at different time points. Kaplan-Meier analysis to evaluate the cumulative survival of SMART sealants and survival of caries-free hypomineralised molars in both groups. Chi-Square test was used to compare the success percentages of the SDF and SMART groups. To assess the changes in success percentages at three different time intervals for the caries preventive effect of SDF and SMART, and to evaluate the retention percentages for the SMART group. McNemar’s test with a Bonferroni correction was used for significant differences. Cohen’s kappa test indicated that the inter-examiner reliability determining the presence of MIH was 0.87. The intra-examiner reliability for US Public Health Service (USPHS)-Modified criteria was 0.90. The statistical significance level was set at p < 0.05 for all statistical analyses.
At 12, 24 and 36 months the caries preventive effect was 100%, 67.9%, and 65.4% for SDF + KI-treated teeth; and 100%, 97.6%, and 94.7% for SMART (SDF + KI + GIC) respectively. During the recall period, there was no substantial difference in hypersensitivity scores between the groups. There was no hypersensitivity in teeth at 18 months and beyond. Compared to the baseline Schiff Cold Air Sensitivity Scale (SCASS) score 26 molar with initial hypersensitivity to hypomineralisation had a massive reduction at evaluation periods. The mean survival probabilities for the caries-preventive effect were considerably lower in SDF + KI-treated teeth (31.01 months) than in SMART-treated teeth (35.61 months) (p < 0.001).
Considering the limitation of the study, both SMART (SDF + KI + GIC) sealants and 6-monthly application of SDF + KI, provided similar and substantial levels of desensitisation on the permanent MIH molars. When used as a sealing material on non-cavitated permanent MIH molars, the clinical retention rate for SMART was 88.7%, 73.1%, and 66.6% at 1, 2, and 3 years respectively. The caries preventive effect of SMART (SDF + KI + GIC) sealants was superior to SDF + KI application in hypomineralised teeth, however, a long-term monitoring and review is essential due to the gradual decrease in retention of SMART sealants.
This is a preview of subscription content, access via your institution
Subscribe to this journal
Receive 4 print issues and online access
251,40 € per year
only 62,85 € per issue
Buy this article
Prices may be subject to local taxes which are calculated during checkout
Weerheijm KL, Duggal M, Mejàre I, Papagiannoulis L, Koch G, Martens LC, et al. Judgement criteria for molar incisor hypomineralisation (MIH) in epidemiologic studies: a summary of the European meeting on MIH held in Athens, 2003. Eur J Paediatr Dent. 2003;4:110–3.
PubMed CAS Google Scholar
Fagrell TG, Dietz W, Jälevik B, Norén JG. Chemical, mechanical and morphological properties of hypomineralized enamel of permanent first molars. Acta Odontol Scand. 2010;68:215–22.
Article PubMed CAS Google Scholar
Jälevik B, Dietz W, Norén JG. Scanning electron micrograph analysis of hypomineralized enamel in permanent first molars. Int J Paediatr Dent. 2005;15:233–40.
Article PubMed Google Scholar
Farah R, Drummond B, Swain M, Williams S. Linking the clinical presentation of molar-incisor hypomineralisation to its mineral density. Int J Paediatr Dent. 2010;20:353–60.
Lygidakis NA, Garot E, Somani C, Taylor GD, Rouas P, Wong FSL. Best clinical practice guidance for clinicians dealing with children presenting with molar-incisor-hypomineralisation (MIH): an updated European Academy of Paediatric Dentistry policy document. Eur Arch Paediatr Dent. 2022;23:3–21.
de Oliveira DC, Favretto CO, Cunha RF. Molar incisor hypomineralization: considerations about treatment in a controlled longitudinal case. J Indian Soc Pedod Prev Dent. 2015;33:152–5.
Unverdi GE, Ballikaya E, Cehreli ZC. Clinical comparison of silver diamine fluoride (SDF) or silver-modified atraumatic restorative technique (SMART) on hypomineralised permanent molars with initial carious lesions: 3-year results of a prospective, randomised trial. J Dent. 2024;147:105098.
Article Google Scholar
Fragelli CMB, Souza JF, Bussaneli DG, Jeremias F, Santos-Pinto LD, Cordeiro RCL. Survival of sealants in molars affected by molar-incisor hypomineralization: 18-month follow-up. Braz Oral Res. 2017;31:e30.
Bekes K, Amend S, Priller J, Zamek C, Stamm T, Krämer N. Hypersensitivity relief of MIH-affected molars using two sealing techniques: a 12-week follow-up. Clin Oral Investig. 2022;26:1879–88.
Schraverus MS, Olegário IC, Bonifácio CC, González APR, Pedroza M, Hesse D. Glass ionomer sealants can prevent dental caries but cannot prevent posteruptive breakdown on molars affected by molar incisor hypomineralization: one-year results of a randomized clinical trial. Caries Res. 2021;55:301–9.
Ruff RR, Barry-Godín T, Niederman R. Effect of silver diamine fluoride on caries arrest and prevention: the carried away school-based randomized clinical trial. JAMA Netw Open. 2023;6:e2255458.
Article PubMed PubMed Central Google Scholar
Erbas Unverdi G, Ballikaya E, Cehreli ZC. Clinical comparison of silver diamine fluoride (SDF) or silver-modified atraumatic restorative technique (SMART) on hypo mineralised permanent molars with early diagnosis and management to initial carious lesions: 3-year results of a prospective, Early diagnosis and management to randomised trial. J Dent. 2024;147:105098.
Download references
Authors and affiliations.
Stourcote Dental Practice, Stourbridge, Birmingham, DY8 1TS, UK
Meenakshi Lall
You can also search for this author in PubMed Google Scholar
Correspondence to Meenakshi Lall .
Competing interests.
The authors declare no competing interests.
Publisher’s note Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
Reprints and permissions
Cite this article.
Lall, M. Is SDF better than the SMART (silver modified atraumatic restorative technique) in the management of molar incisor hypomineralisation molars with initial caries?. Evid Based Dent (2024). https://doi.org/10.1038/s41432-024-01062-y
Download citation
Received : 31 July 2024
Accepted : 02 August 2024
Published : 10 September 2024
DOI : https://doi.org/10.1038/s41432-024-01062-y
Anyone you share the following link with will be able to read this content:
Sorry, a shareable link is not currently available for this article.
Provided by the Springer Nature SharedIt content-sharing initiative
The library building will be open from 9:00am-3:00pm on Friday, March 29th. Our services will be available online 7:45am-4:30pm for your convenience.
The limitations of the study are those characteristics of design or methodology that impacted or influenced the application or interpretation of the results of your study. They are the constraints on generalizability and utility of findings that are the result of the ways in which you chose to design the study and/or the method used to establish internal and external validity.
Always acknowledge a study's limitations. It is far better for you to identify and acknowledge your study’s limitations than to have them pointed out by your professor and be graded down because you appear to have ignored them.
Keep in mind that acknowledgement of a study's limitations is an opportunity to make suggestions for further research . If you do connect your study's limitations to suggestions for further research, be sure to explain the ways in which these unanswered questions may become more focused because of your study.
Acknowledgement of a study's limitations also provides you with an opportunity to demonstrate to your professor that you have thought critically about the research problem, understood the relevant literature published about it, and correctly assessed the methods chosen for studying the problem. A key objective of the research process is not only discovering new knowledge but also to confront assumptions and explore what we don't know.
Claiming limitations is a subjective process because you must evaluate the impact of those limitations. Don't just list key weaknesses and the magnitude of a study's limitations. To do so diminishes the validity of your research because it leaves the reader wondering whether, or in what ways, limitation(s) in your study may have impacted the findings and conclusions. Limitations require a critical, overall appraisal and interpretation of their impact. You should answer the question: do these problems with errors, methods, validity, etc. eventually matter and, if so, to what extent?
Structure: How to Structure the Research Limitations Section of Your Dissertation . Dissertations and Theses: An Online Textbook. Laerd.com.
All studies have limitations. However, it is important that you restrict your discussion to limitations related to the research problem under investigation. For example, if a meta-analysis of existing literature is not a stated purpose of your research, it should not be discussed as a limitation. Do not apologize for not addressing issues that you did not promise to investigate in your paper.
Here are examples of limitations you may need to describe and to discuss how they possibly impacted your findings. Descriptions of limitations should be stated in the past tense.
Possible Methodological Limitations
Sample size -- the number of the units of analysis you use in your study is dictated by the type of research problem you are investigating. Note that, if your sample size is too small, it will be difficult to find significant relationships from the data, as statistical tests normally require a larger sample size to ensure a representative distribution of the population and to be considered representative of groups of people to whom results will be generalized or transferred.
Lack of available and/or reliable data -- a lack of data or of reliable data will likely require you to limit the scope of your analysis, the size of your sample, or it can be a significant obstacle in finding a trend and a meaningful relationship. You need to not only describe these limitations but to offer reasons why you believe data is missing or is unreliable. However, don’t just throw up your hands in frustration; use this as an opportunity to describe the need for future research.
Lack of prior research studies on the topic -- citing prior research studies forms the basis of your literature review and helps lay a foundation for understanding the research problem you are investigating. Depending on the currency or scope of your research topic, there may be little, if any, prior research on your topic. Before assuming this to be true, consult with a librarian! In cases when a librarian has confirmed that there is a lack of prior research, you may be required to develop an entirely new research typology [for example, using an exploratory rather than an explanatory research design]. Note that this limitation can serve as an important opportunity to describe the need for further research.
Measure used to collect the data -- sometimes it is the case that, after completing your interpretation of the findings, you discover that the way in which you gathered data inhibited your ability to conduct a thorough analysis of the results. For example, you regret not including a specific question in a survey that, in retrospect, could have helped address a particular issue that emerged later in the study. Acknowledge the deficiency by stating a need in future research to revise the specific method for gathering data.
Self-reported data -- whether you are relying on pre-existing self-reported data or you are conducting a qualitative research study and gathering the data yourself, self-reported data is limited by the fact that it rarely can be independently verified. In other words, you must take what people say, whether in interviews, focus groups, or on questionnaires, at face value. However, self-reported data contain several potential sources of bias that should be noted as limitations: (1) selective memory (remembering or not remembering experiences or events that occurred at some point in the past); (2) telescoping [recalling events that occurred at one time as if they occurred at another time]; (3) attribution [the act of attributing positive events and outcomes to one's own agency but attributing negative events and outcomes to external forces]; and, (4) exaggeration [the act of representing outcomes or embellishing events as more significant than is actually suggested from other data].
Possible Limitations of the Researcher
Access -- if your study depends on having access to people, organizations, or documents and, for whatever reason, access is denied or otherwise limited, the reasons for this need to be described.
Longitudinal effects -- unlike your professor, who can devote years [even a lifetime] to studying a single research problem, the time available to investigate a research problem and to measure change or stability within a sample is constrained by the due date of your assignment. Be sure to choose a topic that does not require an excessive amount of time to complete the literature review, apply the methodology, and gather and interpret the results. If you're unsure, talk to your professor.
Cultural and other types of bias -- we all have biases, whether we are conscience of them or not. Bias is when a person, place, or thing is viewed or shown in a consistently inaccurate way. It is usually negative, though one can have a positive bias as well. When proof-reading your paper, be especially critical in reviewing how you have stated a problem, selected the data to be studied, what may have been omitted, the way you have ordered events, people, or places and how you have chosen to represent a person, place, or thing, to name a phenomenon, or to use possible words with a positive or negative connotation. Note that if you detect bias in prior research, it must be acknowledged, and you should explain what measures were taken to avoid perpetuating bias.
Fluency in a language -- if your research focuses on measuring the perceived value of after-school tutoring among Mexican American ESL [English as a Second Language] students, for example, and you are not fluent in Spanish, you are limited in being able to read and interpret Spanish language research studies on the topic. This deficiency should be acknowledged.
Brutus, Stéphane et al. Self-Reported Limitations and Future Directions in Scholarly Reports: Analysis and Recommendations. Journal of Management 39 (January 2013): 48-75; Senunyeme, Emmanuel K. Business Research Methods . Powerpoint Presentation. Regent University of Science and Technology.
Information about the limitations of your study is generally placed either at the beginning of the discussion section of your paper so the reader knows and understands the limitations before reading the rest of your analysis of the findings, or the limitations are outlined at the conclusion of the discussion section as an acknowledgement of the need for further study. Statements about a study's limitations should not be buried in the body [middle] of the discussion section unless a limitation is specific to something covered in that part of the paper. If this is the case, though, the limitation should be reiterated at the conclusion of the section.
If you determine that your study is seriously flawed due to important limitations, such as an inability to acquire critical data, consider reframing it as a pilot study intended to lay the groundwork for a more complete research study in the future. Be sure, though, to specifically explain the ways that these flaws can be successfully overcome in later studies.
But do not use this as an excuse for not developing a thorough research paper! Review the tab in this guide for developing a research topic. If serious limitations exist, it generally indicates a likelihood that your research problem is too narrowly defined or that the issue or event under study is too recent and, thus, very little research has been written about it. If serious limitations do emerge, consult with your professor about possible ways to overcome them or how to reframe your study.
When discussing the limitations of your research, be sure to:
Describe each limitation in detailed but concise terms;
Explain why each limitation exists;
Provide the reasons why each limitation could not be overcome using the method(s) chosen to gather the data [cite to other studies that had similar problems when possible];
Assess the impact of each limitation in relation to the overall findings and conclusions of your study; and,
If appropriate, describe how these limitations could point to the need for further research.
Remember that the method you chose may be the source of a significant limitation that has emerged during your interpretation of the results [for example, you didn't ask a particular question in a survey that you later wish you had]. If this is the case, don't panic. Acknowledge it and explain how applying a different or more robust methodology might address the research problem more effectively in any future study. An underlying goal of scholarly research is not only to prove what works, but to demonstrate what doesn't work or what needs further clarification.
Brutus, Stéphane et al. Self-Reported Limitations and Future Directions in Scholarly Reports: Analysis and Recommendations. Journal of Management 39 (January 2013): 48-75; Ioannidis, John P.A. Limitations are not Properly Acknowledged in the Scientific Literature. Journal of Clinical Epidemiology 60 (2007): 324-329; Pasek, Josh. Writing the Empirical Social Science Research Paper: A Guide for the Perplexed . January 24, 2012. Academia.edu; Structure: How to Structure the Research Limitations Section of Your Dissertation . Dissertations and Theses: An Online Textbook. Laerd.com; What Is an Academic Paper? Institute for Writing Rhetoric. Dartmouth College; Writing the Experimental Report: Methods, Results, and Discussion. The Writing Lab and The OWL. Purdue University.
Don't Inflate the Importance of Your Findings! After all the hard work and long hours devoted to writing your research paper, it is easy to get carried away with attributing unwarranted importance to what you’ve done. We all want our academic work to be viewed as excellent and worthy of a good grade, but it is important that you understand and openly acknowledge the limitations of your study. Inflating the importance of your study's findings in an attempt to hide its flaws is a big turn off to your readers. A measure of humility goes a long way!
Negative Results are Not a Limitation!
Negative evidence refers to findings that unexpectedly challenge rather than support your hypothesis. If you didn't get the results you anticipated, it may mean your hypothesis was incorrect and needs to be reformulated, or perhaps you have stumbled onto something unexpected that warrants further study. Moreover, the absence of an effect may be very telling in many situations, particularly in experimental research designs. In any case, your results may be of importance to others even though they did not support your hypothesis. Do not fall into the trap of thinking that results contrary to what you expected is a limitation to your study. If you carried out the research well, they are simply your results and only require additional interpretation.
A Note about Sample Size Limitations in Qualitative Research
Sample sizes are typically smaller in qualitative research because, as the study goes on, acquiring more data does not necessarily lead to more information. This is because one occurrence of a piece of data, or a code, is all that is necessary to ensure that it becomes part of the analysis framework. However, it remains true that sample sizes that are too small cannot adequately support claims of having achieved valid conclusions and sample sizes that are too large do not permit the deep, naturalistic, and inductive analysis that defines qualitative inquiry. Determining adequate sample size in qualitative research is ultimately a matter of judgment and experience in evaluating the quality of the information collected against the uses to which it will be applied, and the particular research method and purposeful sampling strategy employed. If the sample size is found to be a limitation, it may reflect your judgement about the methodological technique chosen [e.g., single life history study versus focus group interviews] rather than the number of respondents used.
Huberman, A. Michael and Matthew B. Miles. Data Management and Analysis Methods. In Handbook of Qualitative Research. Norman K. Denzin and Yvonna S. Lincoln, eds. (Thousand Oaks, CA: Sage, 1994), pp. 428-444.
COMMENTS
Common types of limitations and their ramifications include: Theoretical: limits the scope, depth, or applicability of a study. Methodological: limits the quality, quantity, or diversity of the data. Empirical: limits the representativeness, validity, or reliability of the data. Analytical: limits the accuracy, completeness, or significance of ...
Possible Limitations of the Researcher. Access-- if your study depends on having access to people, organizations, data, or documents and, for whatever reason, access is denied or limited in some way, the reasons for this needs to be described.Also, include an explanation why being denied or limited access did not prevent you from following through on your study.
Limitations in Research. Limitations in research refer to the factors that may affect the results, conclusions, and generalizability of a study.These limitations can arise from various sources, such as the design of the study, the sampling methods used, the measurement tools employed, and the limitations of the data analysis techniques.
In research, studies can have limitations such as limited scope, researcher subjectivity, and lack of available research tools. Acknowledging the limitations of your study should be seen as a strength. It demonstrates your willingness for transparency, humility, and submission to the scientific method and can bolster the integrity of the study.
Research limitations are one of those things that students tend to avoid digging into, and understandably so. No one likes to critique their own study and point out weaknesses. Nevertheless, being able to understand the limitations of your study - and, just as importantly, the implications thereof - a is a critically important skill. In this post, we'll unpack some of the most common ...
sentence tha. signals what you're about to discu. s. For example:"Our study had some limitations."Then, provide a concise sentence or two identifying each limitation and explaining how the limitation may have affected the quality. of the study. s findings and/or their applicability. For example:"First, owing to the rarity of the ...
Writing the limitations of the research papers is often assumed to require lots of effort. However, identifying the limitations of the study can help structure the research better. Therefore, do not underestimate the importance of research study limitations. 3. Opportunity to make suggestions for further research.
Methodology limitations. Not having access to data or reliable information can impact the methods used to facilitate your research. A lack of data or reliability may limit the parameters of your study area and the extent of your exploration. Your sample size may also be affected because you won't have any direction on how big or small it ...
How scientists present them can make a big difference. iStock, Jacob Wackerhausen. Scientists work with many different limitations. First and foremost, they navigate informational limitations, work around knowledge gaps when designing studies, formulating hypotheses, and analyzing data. They also handle technical limitations, making the most of ...
3. Identify your limitations of research and explain their importance. 4. Provide the necessary depth, explain their nature, and justify your study choices. 5. Write how you are suggesting that it is possible to overcome them in the future. Limitations can help structure the research study better.
Limited by our limitations. Study limitations represent weaknesses within a research design that may influence outcomes and conclusions of the research. Researchers have an obligation to the academic community to present complete and honest limitations of a presented study. Too often, authors use generic descriptions to describe study limitations.
Step 1. Identify the limitation (s) of the study. This part should comprise around 10%-20% of your discussion of study limitations. The first step is to identify the particular limitation (s) that affected your study. There are many possible limitations of research that can affect your study, but you don't need to write a long review of all ...
Acknowledgement of a study's limitations also provides you with an opportunity to demonstrate that you have thought critically about the research problem, understood the relevant literature published about it, and correctly assessed the methods chosen for studying the problem. A key objective of the research process is not only discovering new ...
The limitations of the study are those characteristics of design or methodology that impacted or influenced the application or interpretation of the results of your study. They are the constraints on generalizability and utility of findings that are the result of the ways in which you chose to design the study and/or the method used to ...
While each study will have its own unique set of limitations, some limitations are more common in quantitative research, and others are more common in qualitative research. In quantitative research, common limitations include the following: - Participant dropout. - Small sample size, low power. - Non-representative sample.
Research Limitations. Research limitations are, at the simplest level, the weaknesses of the study, based on factors that are often outside of your control as the researcher. These factors could include things like time, access to funding, equipment, data or participants.For example, if you weren't able to access a random sample of participants for your study and had to adopt a convenience ...
A large body of work recognizes the effect(s) and consequence(s) of limitations. 1-77 Other than the ones known to the author(s), unknown and unrecognized limitations influence research credibility. This study and analysis aim to determine how frequently and what limitations are found in peer-reviewed open-access medical articles for ...
The ideal way is to divide your limitations section into three steps: 1. Identify the research constraints; 2. Describe in great detail how they affect your research; 3. Mention the opportunity for future investigations and give possibilities. By following this method while addressing the constraints of your research, you will be able to ...
Answer: The limitations of a study are its flaws or shortcomings which could be the result of unavailability of resources, small sample size, flawed methodology, etc. No study is completely flawless or inclusive of all possible aspects. Therefore, listing the limitations of your study reflects honesty and transparency and also shows that you ...
Abstract. Study limitations represent weaknesses within a research design that may influence outcomes and conclusions of the research. Researchers have an obligation to the academic community to present complete and honest limitations of a presented study. Too often, authors use generic descriptions to describe study limitations.
Research limitations in a typical dissertation may relate to the following points: 1. Formulation of research aims and objectives. You might have formulated research aims and objectives too broadly. You can specify in which ways the formulation of research aims and objectives could be narrowed so that the level of focus of the study could be ...
For instance, a study involving females only or carried out in a specific town can have limitations like sample size, gender, and location. What's more, the entire study could be limited to the researcher's perception. Lack of or inadequate training: The research process doesn't have a systematic methodology.
One of the key defining characteristics of rapid qualitative research and evaluation is their iterative design (Beebe, 2001, McNall et al., 2004).The term 'iterative' refers to a repetitive, circular, constantly changing research process where 'cycles' or 'loops' are used to generate evidence, reflect on the findings, obtain feedback, and inform changes in the original study design.
The average readability of informed consent forms of federally funded clinical trials exceeds the reading comprehension skills of the majority of adults in the U.S., potentially undermining clinical trial participant retention rates. Future work should explore the use of large language models and other tools as possible means to close this literacy barrier and potentially enhancing clinical ...
Background With advancements in burn treatment and intensive care leading to decreased mortality rates, a growing cohort of burn survivors is emerging. These individuals may be susceptible to frailty, characterized by reduced physiological reserve and increased vulnerability to stressors commonly associated with aging, which significantly complicates their recovery process. To date, no study ...
Empirical: Empirical research is a way of gaining knowledge through observation or experience. Empirical research contrasts with theoretical research, which relies on systems of logic, beliefs, and assumptions. Predictor: A predictor variable, is a factor that influences another variable in a correlational study. For example, the length of a ...
This study has several limitations. First, respondents were selected by their organization directors following administrative procedures mandated by research projects in Lao PDR. While this method has likely allowed to capture a diverse range of perspectives on malnutrition, it may have excluded individuals who disagreed with the official ...
Objective To estimate the real world effectiveness of modified vaccinia Ankara-Bavarian Nordic (MVA-BN) vaccine against mpox infection. Design Emulation of a target trial. Setting Linked databases in Ontario, Canada. Participants 9803 men aged ≥18 years with a history of being tested for syphilis and a laboratory confirmed bacterial sexually transmitted infection (STI) in the previous year ...
A prospective, randomized, split-mouth clinical study by the two previously trained and calibrated pediatric dentists without blinding operators and patients due to different protocols in both ...
Don't just list key weaknesses and the magnitude of a study's limitations. To do so diminishes the validity of your research because it leaves the reader wondering whether, or in what ways, limitation(s) in your study may have impacted the findings and conclusions. Limitations require a critical, overall appraisal and interpretation of their ...