Reviewer Disclosure of Competing Interests

For this particular manuscript, do you or your spouse or your child under age 18  have any financial association with any commercial entity which might have an interest in the area of work in the submitted manuscript?

For this particular manuscript, do you have any non-financial personal  or professional interests or affiliations which might affect the area of work in the submitted manuscript?

Assessing the Methodological Quality of a Manuscript

Mission Relevance

• Is the topic and research within this manuscript relevant to the mission of ILM JAHM, which is to explore the intersection of health care, ethics, and law that affects the most vulnerable human beings in our communities

Research Objectives:

• Are the objectives stated clearly in the abstract and introduction?
• Are the objectives and hypothesis logical and internally consistent?
• Do the objectives address a clearly identified gap in the existing medical, legal, or policy literature

Plagiarism Screen

• Does the manuscript contain sections created by AI?
• Does the manuscript include work created by others without proper attribution/citation?
• Does the manuscript mention trademarks?

Study Design:

• Is the study design appropriate for the stated research objectives?
• Is there an adequate statement regarding ethics committee/IRB approval or exemption?
• Are informed consent procedures adequately described or justified?
• Are data privacy, confidentiality, and legal compliance issues appropriately addressed?
• Is the analytic or interpretive framework clearly articulated and appropriate?
• If data was collected during routine clinical care, do the authors discuss the consistency, accuracy, availability and completeness of the source media?
• Was a control or comparison group used and if not, should it have been?
• If the study is uncontrolled, does it make unjustified claims of efficacy or effectiveness?
• Is the natural history or spontaneous improvement rate discussed?
• Are there problems with duration of follow-up, response rate or dropout rate?
• REVIEW ARTICLES:  Were there systematic criteria for study selection?
• REVIEW ARTICLES: Was there balanced consideration of all available evidence when drawing a conclusion?
• EPIDEMIOLOGY ARTICLES If this is an epidemiological study, is the study design appropriate?
• EPIDEMIOLOGY ARTICLES: Is the population(s) studied appropriate for the endpoints proposed?”

Methodology

• Are the tests, surveys and outcome measures appropriate, valid and unbiased?
• Inclusion criteria:  Was there random or consecutive sampling and clear criteria for subject inclusion and exclusion?
• Allocation to treatment:  Was their random and blinded allocation of subjects to treatment groups, including all subjects randomized?
• Allocation to treatment: Were all subjects included in the final analysis, (Intention to treat included?)
• Outcome assessment:  Was the assessment made using objective or validated measures?
• Outcome assessment:  Was the assessment made by observers blinded to treatment status?
• Are the specific methods described in adequate detail to allow for replication?
• Is there excessive detail in the methods section which should be placed in an appendix?
• Are the methods for statistical analysis described and referenced?
• Adverse Events: if interventional study, does the manuscript discuss adverse events and risk/benefit of the intervention?

Sample Size

• Is the sample size stated clearly in the abstract and text?
• Is there a need for a sample size calculation which the authors did not include?
• Is the study adequately powered to support the analysis done?
• If the  study conclusions state “no difference” or “no adverse effects” does the sample size give adequate statistical power to make such a conclusion?

Descriptive Statistics

• If there are small samples or skewed data, are they described with median and interquartile range instead of mean and standard deviation?
• If there are “significant” findings, do the authors describe effect size (e.g.  odds ratio, relative risk, correlation coefficient) and discuss clinical relevance?
• If this is a prospective study do authors discuss a survival analysis for loss to follow up or when events may have occurred after the conclusion of the study period?
• Is the effect size noted (especially for epidemiological studies and surveys)

Inferential Statistics

• Are claims of significant or important findings supported by statistical analysis?
• Are paired or matched data (e.g. before and after) analyzed appropriately?
• If there are less than 20 observations per group, do the authors check the data distribution for asymmetry or outliers that warrant non parametric or exact tests?
• When 3 or more groups are compared, do the authors first test for a global difference (analysis of variance) before making pairwise comparisons?
• When multiple factors are related to an outcome, do the authors use regression analysis to avoid the false positive problem of multiple individual tests?
• Is missing data handled appropriately?
• Are there appropriate controls for multiple parameters?

General Manuscript assessment

• Disclosures:   The manuscript has clear statements of funding source and authors competing interests including  financial, industrial and other interests.
• Abstract:  The manuscript has a structured summary of goals, methods, results and clinical significance.
• Introduction:  The introduction is clear, concise and logical and ends with the purpose of the study
• Methods:  The methods are specific enough for the study to be reproduced and are consistent with the study design.
• Results:  The results are logical and clearly presented.
• Discussion:   The discussion discusses the main points, reviews the supporting and conflicting literature and discusses strengths weaknesses and limitations.
• References:  References demonstrate the significant work of others in the topic.
• Are counter arguments or alternative interpretations fairly considered? (This can be helpful as one can do the bare minimum or misrepresent conflicting literature)
• Are normative claims clearly distinguished from empirical findings?
• Does the manuscript make a substantive contribution to law and medicine scholarship?
• Are implications for law, policy, regulation, or clinical practice clearly and responsibly articulated?

Reviewer Recommendation

• Accept
• Minor revision
• Major revision
• Reject

Revision Review

• If a revision is suggested, are you willing to review the revision?