reporting-checklist

name	reporting-checklist
category	quality
discipline	general
description	Reporting guideline compliance checker for CONSORT, STROBE, PRISMA, ARRIVE, and CARE checklists

Reporting Checklist

Protocol for selecting the correct reporting guideline and verifying compliance with its key items. Based on the EQUATOR (Enhancing the QUAlity and Transparency Of health Research) Network resources.

When to Use

• Before submission to verify all reporting requirements are met
• During manuscript drafting to ensure completeness
• When a journal requires a completed reporting checklist with submission
• When reviewing a manuscript for reporting completeness

---

Protocol

1. Guideline Selection Flowchart

Select the appropriate guideline based on study design:

What type of study is this?
|
|-- Interventional study?
|   |-- Randomized allocation? --> CONSORT 2010
|   |-- Non-randomized intervention? --> TREND
|   |-- Pilot/feasibility study? --> CONSORT Extension for Pilot Trials
|
|-- Observational study?
|   |-- Cohort study? --> STROBE (Cohort)
|   |-- Case-control study? --> STROBE (Case-Control)
|   |-- Cross-sectional study? --> STROBE (Cross-Sectional)
|
|-- Systematic review?
|   |-- With meta-analysis? --> PRISMA 2020
|   |-- Without meta-analysis? --> PRISMA 2020
|   |-- Scoping review? --> PRISMA-ScR
|   |-- Network meta-analysis? --> PRISMA-NMA
|
|-- Diagnostic/prognostic study?
|   |-- Diagnostic accuracy? --> STARD 2015
|   |-- Prediction model? --> TRIPOD
|   |-- Prognostic study? --> REMARK
|
|-- Case report/series? --> CARE
|
|-- Qualitative study? --> COREQ / SRQR
|
|-- Animal study? --> ARRIVE 2.0
|
|-- Quality improvement? --> SQUIRE 2.0
|
|-- Economic evaluation? --> CHEERS 2022
|
|-- Clinical practice guideline? --> AGREE II / RIGHT

2. CONSORT 2010 (Randomized Controlled Trials)

Full name: Consolidated Standards of Reporting Trials Reference: Schulz KF, Altman DG, Moher D. CONSORT 2010 statement. BMJ. 2010;340:c332.

Key Items (25 items organized by section)

Title and Abstract (Items 1a-1b):

• 1a. Identification as a randomised trial in the title
• 1b. Structured summary of trial design, methods, results, and conclusions

Introduction (Item 2):

• 2a. Scientific background and explanation of rationale
• 2b. Specific objectives or hypotheses

Methods (Items 3-12):

• 3a. Description of trial design (e.g., parallel, factorial)
• 3b. Important changes to methods after trial commencement, with reasons
• 4a. Eligibility criteria for participants
• 4b. Settings and locations where data were collected
• 5. Interventions for each group with sufficient detail for replication
• 6a. Completely defined pre-specified primary and secondary outcome measures
• 6b. Any changes to trial outcomes after the trial commenced, with reasons
• 7a. How sample size was determined
• 7b. When applicable, explanation of any interim analyses and stopping guidelines
• 8a. Method used to generate the random allocation sequence
• 8b. Type of randomisation; details of any restriction
• 9. Mechanism used to implement the allocation sequence, describing concealment
• 10. Who generated the allocation sequence, who enrolled participants, who assigned participants
• 11a. If done, who was blinded after assignment to interventions and how
• 11b. Description of the similarity of interventions (if blinded)
• 12a. Statistical methods used to compare groups for primary and secondary outcomes
• 12b. Methods for additional analyses (e.g., subgroup, adjusted)

Results (Items 13-19):

• 13a. Flow of participants through each stage (CONSORT flow diagram recommended)
• 13b. For each group, losses and exclusions after randomisation with reasons
• 14a. Dates defining the periods of recruitment and follow-up
• 14b. Why the trial ended or was stopped
• 15. Table showing baseline demographic and clinical characteristics for each group
• 16. For each primary and secondary outcome: results for each group, estimated effect size, and precision (95% CI)
• 17a. For binary outcomes: both absolute and relative effect sizes
• 17b. Results of any other analyses performed (subgroup, adjusted)
• 18. All important harms or unintended effects in each group
• 19. Trial registration number and name of trial registry

Discussion (Items 20-22):

• 20. Trial limitations, addressing sources of potential bias and imprecision
• 21. Generalisability of the trial findings
• 22. Interpretation consistent with results, balancing benefits and harms

Other (Items 23-25):

• 23. Registration number and name of trial registry
• 24. Where the full trial protocol can be accessed
• 25. Sources of funding and other support, role of funders

3. STROBE (Observational Studies)

Full name: Strengthening the Reporting of Observational Studies in Epidemiology Reference: von Elm E, Altman DG, Egger M, et al. STROBE statement. PLoS Med. 2007;4(10):e296.

Key Items (22 items)

Title and Abstract:

• 1a. Study design indicated in title or abstract
• 1b. Informative and balanced summary

Introduction:

• 2. Scientific background and rationale
• 3. Specific objectives, including any prespecified hypotheses

Methods:

• 4. Study design presented early in the paper
• 5. Setting, locations, and relevant dates (enrollment, exposure, follow-up, data collection)
• 6. Eligibility criteria, sources, and methods of selection; follow-up methods (cohort); matching criteria (case-control); rationale for sample (cross-sectional)
• 7. Outcomes, exposures, predictors, potential confounders, and effect modifiers clearly defined
• 8. Data sources and measurement for each variable of interest
• 9. How bias was addressed
• 10. How the study size was arrived at
• 11. How quantitative variables were handled in analyses
• 12. All statistical methods, including those for confounders, interactions, missing data, sensitivity analyses

Results:

• 13. Number of participants at each stage, with reasons for non-participation
• 14. Descriptive data: characteristics of study participants, number with missing data
• 15. Outcome data: number of outcome events or summary measures
• 16. Main results: unadjusted estimates and confounder-adjusted estimates with CIs
• 17. Other analyses performed (subgroup, interaction, sensitivity)

Discussion:

• 18. Key results with reference to study objectives
• 19. Limitations, including sources of potential bias and direction of bias
• 20. Cautious overall interpretation considering objectives, limitations, multiplicity, and other evidence
• 21. Generalisability of the study results

Other:

• 22. Sources of funding and role of funders

4. PRISMA 2020 (Systematic Reviews)

Full name: Preferred Reporting Items for Systematic Reviews and Meta-Analyses Reference: Page MJ, McKenzie JE, Bossuyt PM, et al. The PRISMA 2020 statement. BMJ. 2021;372:n71.

Key Items (27 items)

Title (Item 1):

• 1. Identify the report as a systematic review

Abstract (Item 2):

• 2. Structured summary per PRISMA for Abstracts

Introduction (Items 3-4):

• 3. Rationale for the review in context of existing knowledge
• 4. Explicit statement of the questions being addressed (PICO)

Methods (Items 5-16):

• 5. Registration and protocol (PROSPERO number, protocol publication)
• 6. Eligibility criteria (PICO elements)
• 7. Information sources (databases, registers, other sources with dates of coverage)
• 8. Complete search strategy for at least one database
• 9. Selection process (screening, eligibility, number of reviewers)
• 10. Data collection process (data extraction, number of reviewers, confirmation)
• 11. List and define all outcomes for which data were sought
• 12. Risk of bias assessment (tool used, how applied, how used in synthesis)
• 13a. Synthesis methods: processes for deciding which studies were eligible for each synthesis
• 13b. Methods for any quantitative synthesis (meta-analysis model, heterogeneity measures)
• 13c. Methods for investigating heterogeneity (subgroup, sensitivity, meta-regression)
• 13d. Sensitivity analyses
• 13e. Publication bias assessment methods
• 14. Methods for assessing certainty of evidence (e.g., GRADE)

Results (Items 15-23):

• 16a. Numbers of records identified, screened, assessed, included (PRISMA flow diagram)
• 16b. Reasons for exclusion at full-text stage
• 17. Characteristics of included studies
• 18. Risk of bias within individual studies
• 19. Results of individual studies (forest plot for meta-analyses)
• 20a. Results of each synthesis (summary statistics with CIs)
• 20b. Heterogeneity results (I-squared, tau-squared, Q test)
• 20c. Results of sensitivity analyses
• 21. Results of publication bias assessment
• 22. Certainty of evidence for each outcome

Discussion (Items 23-26):

• 23. General interpretation in context of other evidence
• 24. Limitations of the evidence and review process
• 25. Implications for practice, policy, and future research

Other (Item 27):

• 27. Sources of funding, role of funders, conflicts of interest

5. CARE (Case Reports)

Full name: CAse REport guidelines Reference: Gagnier JJ, Kienle G, Altman DG, et al. The CARE guidelines. J Clin Epidemiol. 2014;67(1):46-51.

Key Items (13 items)

• 1. Title: identify as a case report and include the diagnosis
• 2. Key words: 2-5 key words
• 3. Abstract: structured summary (introduction, case, conclusion)
• 4. Introduction: brief background, why the case is reportable
• 5a. Patient demographics and relevant medical history
• 5b. Main symptoms and clinical findings
• 5c. Timeline of events (consider a figure/table)
• 5d. Diagnostic assessment: tests, diagnoses, and reasoning
• 6. Therapeutic interventions and their administration
• 7. Follow-up and outcomes: clinician and patient-assessed
• 8. Discussion: strengths, limitations, comparison with literature, rationale for conclusions
• 9. Patient perspective (when appropriate)
• 10. Informed consent obtained and documented

6. ARRIVE 2.0 (Animal Studies)

Full name: Animal Research: Reporting of In Vivo Experiments Reference: Percie du Sert N, et al. The ARRIVE guidelines 2.0. PLoS Biol. 2020;18(7):e3000410.

Essential 10 Items

• 1. Study design: type, independent variable, groups, experimental unit
• 2. Sample size: number per group, how calculated, power analysis
• 3. Inclusion/exclusion criteria: before enrollment and during study
• 4. Randomisation: method, level, sequence generation
• 5. Blinding: who was blinded, how assessed
• 6. Outcome measures: primary and secondary, with assessment timing
• 7. Statistical methods: tests, software, significance threshold
• 8. Experimental animals: species, strain, sex, age, weight, source
• 9. Experimental procedures: all procedures in sufficient detail for replication
• 10. Results: for each outcome, summary and variability measures

Recommended Items (11 additional)

• 11. Abstract: species, key methods, principal findings
• 12. Background: sufficient context, review of evidence
• 13. Objectives: specific aims or hypotheses
• 14. Ethical statement: approval body and number
• 15. Housing and husbandry: conditions, welfare-related assessments
• 16. Animal care and monitoring: acclimatization, health monitoring
• 17. Interpretation/scientific implications: relate to objectives
• 18. Generalisability/translation: relevance to other species/humans
• 19. Protocol registration
• 20. Data access: data availability statement
• 21. Declaration of interests

7. STARD 2015 (Diagnostic Accuracy Studies)

Full name: Standards for Reporting of Diagnostic Accuracy Studies Reference: Bossuyt PM, et al. STARD 2015. BMJ. 2015;351:h5527.

Key Items (30 items, abbreviated)

• Title identifies as a diagnostic accuracy study
• Study design (prospective or retrospective, cross-sectional or cohort)
• Clinical role of index test (diagnosis, screening, staging, monitoring)
• Participants: eligibility criteria, settings, recruitment
• Reference standard and rationale
• Index test technique described in detail
• Rationale for cut-off/threshold if applicable
• How blinding was achieved between index and reference test interpretation
• Number of participants at each stage (STARD flow diagram)
• Cross-tabulation of index test results by reference standard
• Sensitivity, specificity, likelihood ratios with CIs
• Inconclusive results reported
• Adverse events reported

8. SQUIRE 2.0 (Quality Improvement Studies)

Full name: Standards for QUality Improvement Reporting Excellence Reference: Ogrinc G, et al. SQUIRE 2.0. BMJ Qual Saf. 2016;25(12):986-992.

Key Items (18 items, abbreviated)

• Nature and significance of the local problem
• Available knowledge (literature summary, rationale for the intervention)
• Specific aim of the QI intervention
• Context: organizational, policy environment, population served
• Intervention description and components
• Study of the intervention: design, measures, analysis
• Ethical considerations
• Results: outcomes, unintended consequences, process measures
• Summary of key findings
• Interpretation in context of evidence
• Limitations (internal and external validity)
• Conclusions including sustainability and spread

---

Checklist

Guideline Selection

• Study design correctly identified
• Appropriate reporting guideline selected from flowchart
• Full checklist downloaded from EQUATOR Network
• Journal-specific requirements checked (some require specific extensions)

Compliance Verification

• Every item in the checklist addressed with page/paragraph reference
• Items marked as "N/A" only when genuinely not applicable (with justification)
• Missing items identified and either added to manuscript or justified for exclusion

Submission

• Completed checklist saved as supplementary document
• Page/line numbers added for each item
• Checklist uploaded with manuscript submission
• Cover letter mentions compliance with reporting guideline

---

References

• EQUATOR Network. Enhancing the QUAlity and Transparency Of health Research. https://www.equator-network.org/
• Schulz KF, Altman DG, Moher D. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ. 2010;340:c332. doi:10.1136/bmj.c332
• von Elm E, Altman DG, Egger M, Pocock SJ, Gotzsche PC, Vandenbroucke JP. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement. PLoS Med. 2007;4(10):e296. doi:10.1371/journal.pmed.0040296
• Page MJ, McKenzie JE, Bossuyt PM, et al. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ. 2021;372:n71. doi:10.1136/bmj.n71
• Gagnier JJ, Kienle G, Altman DG, et al. The CARE guidelines: consensus-based clinical case reporting guideline development. J Clin Epidemiol. 2014;67(1):46-51. doi:10.1016/j.jclinepi.2013.08.003
• Percie du Sert N, Hurst V, Ahluwalia A, et al. The ARRIVE guidelines 2.0: updated guidelines for reporting animal research. PLoS Biol. 2020;18(7):e3000410. doi:10.1371/journal.pbio.3000410
• Bossuyt PM, Reitsma JB, Bruns DE, et al. STARD 2015: an updated list of essential items for reporting diagnostic accuracy studies. BMJ. 2015;351:h5527. doi:10.1136/bmj.h5527
• Ogrinc G, Davies L, Goodman D, et al. SQUIRE 2.0 (Standards for QUality Improvement Reporting Excellence): revised publication guidelines. BMJ Qual Saf. 2016;25(12):986-992. doi:10.1136/bmjqs-2015-004411