Reporting Guidelines for Scientific Studies
Overview
Reporting guidelines are evidence-based recommendations for what information should be included when reporting specific types of research studies. They provide checklists and flow diagrams to ensure complete, accurate, and transparent reporting, which is essential for readers to assess study validity and for other researchers to replicate the work.
The EQUATOR Network (Enhancing the QUAlity and Transparency Of health Research) maintains a comprehensive library of reporting guidelines. Using appropriate reporting guidelines improves manuscript quality and increases the likelihood of publication acceptance.
Why Use Reporting Guidelines?
Benefits
For authors: - Ensures nothing important is forgotten - Increases acceptance rates - Improves manuscript organization - Reduces reviewer requests for additional information
For readers and reviewers: - Enables critical appraisal of study validity - Facilitates systematic reviews and meta-analyses - Improves understanding of what was actually done
For science: - Enhances reproducibility - Reduces research waste - Improves transparency - Enables better evidence synthesis
When to Use
- During study design: Many guidelines include protocol versions (e.g., SPIRIT for trial protocols)
- During manuscript drafting: Use checklist to ensure all items are covered
- Before submission: Verify adherence and often submit checklist with manuscript
- Many journals require: Reporting guideline checklists as part of submission
Major Reporting Guidelines by Study Type
CONSORT - Randomized Controlled Trials
Full name: Consolidated Standards of Reporting Trials
When to use: Any randomized controlled trial (RCT), including pilot and feasibility trials
Latest version: CONSORT 2010 (updated statement)
Key components: - Checklist: 25 items covering title, abstract, introduction, methods, results, discussion - Flow diagram: Participant flow through enrollment, allocation, follow-up, and analysis
Main checklist items: 1. Title identifies study as randomized trial 2. Structured abstract 3. Scientific background and rationale 4. Specific objectives and hypotheses 5. Trial design description (parallel, crossover, factorial, etc.) 6. Eligibility criteria for participants 7. Settings and locations of data collection 8. Interventions described in sufficient detail for replication 9. Primary and secondary outcomes defined 10. Sample size determination and power calculation 11. Randomization sequence generation 12. Allocation concealment mechanism 13. Blinding implementation 14. Statistical methods 15. Participant flow with reasons for dropouts 16. Recruitment dates and follow-up dates 17. Baseline characteristics table 18. Analysis results for each outcome 19. Harms and adverse events 20. Trial limitations 21. Generalizability 22. Interpretation consistent with results 23. Trial registration number 24. Full protocol access 25. Funding sources
Extensions for specific designs: - CONSORT for cluster randomized trials - CONSORT for non-inferiority and equivalence trials - CONSORT for pragmatic trials - CONSORT for crossover trials - CONSORT for N-of-1 trials - CONSORT for stepped wedge designs
Where to access: http://www.consort-statement.org/
STROBE - Observational Studies
Full name: Strengthening the Reporting of Observational Studies in Epidemiology
When to use: Cohort studies, case-control studies, and cross-sectional studies
Latest version: STROBE 2007 (widely adopted standard)
Key study designs covered: - Cohort: Follow exposed and unexposed groups forward in time - Case-control: Compare exposure history between cases and controls - Cross-sectional: Measure exposure and outcome simultaneously
Main checklist items (22 items): 1. Title and abstract indicate study design 2. Background and rationale 3. Objectives 4. Study design with rationale 5. Setting, locations, and dates 6. Eligibility criteria and selection methods 7. Variables clearly defined (outcomes, exposures, confounders) 8. Data sources and measurement methods 9. Bias management strategies 10. Study size justification 11. Handling of quantitative variables 12. Statistical methods including confounding and interactions 13. Sensitivity analyses 14. Participant flow with reasons for non-participation 15. Descriptive data including follow-up time 16. Outcome data 17. Main results with unadjusted and adjusted estimates 18. Other analyses (subgroups, sensitivity analyses) 19. Key results summary 20. Limitations with potential bias discussion 21. Interpretation and generalizability 22. Funding sources and role
Extensions: - STROBE-ME (Molecular Epidemiology) - RECORD (Routinely collected health data) - STROBE-RDS (Respondent-driven sampling)
Where to access: https://www.strobe-statement.org/
PRISMA - Systematic Reviews and Meta-Analyses
Full name: Preferred Reporting Items for Systematic Reviews and Meta-Analyses
When to use: Systematic reviews with or without meta-analysis
Latest version: PRISMA 2020 (significant update)
Key components: - Checklist: 27 items covering all sections - Flow diagram: Study selection process
Main sections: 1. Title: Identify as systematic review/meta-analysis 2. Abstract: Structured summary 3. Introduction: Rationale and objectives 4. Methods: - Eligibility criteria - Information sources (databases, dates) - Search strategy (full strategy for at least one database) - Selection process - Data collection process - Data items extracted - Risk of bias assessment - Effect measures - Synthesis methods - Reporting bias assessment - Certainty assessment (e.g., GRADE) 5. Results: - Study selection flow diagram - Study characteristics - Risk of bias assessment results - Synthesis results (meta-analysis if applicable) - Reporting biases - Certainty of evidence 6. Discussion: - Limitations - Interpretation - Implications
Extensions: - PRISMA for Abstracts - PRISMA for Protocols (PRISMA-P) - PRISMA for Network Meta-Analyses - PRISMA for Scoping Reviews (PRISMA-ScR) - PRISMA for Individual Patient Data - PRISMA for Diagnostic Test Accuracy - PRISMA for Equity-focused reviews
Where to access: http://www.prisma-statement.org/
SPIRIT - Study Protocols for Clinical Trials
Full name: Standard Protocol Items: Recommendations for Interventional Trials
When to use: Protocols for randomized trials and other planned intervention studies
Latest version: SPIRIT 2013
Purpose: Ensure trial protocols contain complete descriptions before trial begins
Main checklist items (33 items): - Administrative information (title, trial registration, funding) - Introduction (background, rationale, objectives) - Methods: Trial design - Study setting - Eligibility criteria - Interventions in detail - Outcomes (primary and secondary) - Participant timeline - Sample size calculation - Recruitment strategy - Allocation and randomization - Blinding - Data collection methods - Data management - Statistical methods - Monitoring (data monitoring committee) - Harms reporting - Auditing - Ethics and dissemination - Ethics approval - Consent procedures - Confidentiality - Dissemination plans
Where to access: https://www.spirit-statement.org/
STARD - Diagnostic Accuracy Studies
Full name: Standards for Reporting of Diagnostic Accuracy Studies
When to use: Studies evaluating diagnostic test accuracy
Latest version: STARD 2015
Main checklist items (30 items): 1. Study design identification 2. Background information and objectives 3. Study design description 4. Participant selection criteria and recruitment 5. Data collection methods 6. Index test description and execution 7. Reference standard description 8. Rationale for choosing reference standard 9. Test result definition and cutoffs 10. Flow of participants with timing 11. Baseline demographic and clinical characteristics 12. Cross-tabulation of index test results by reference standard 13. Estimates of diagnostic accuracy with confidence intervals 14. Handling of indeterminate results 15. Adverse events from testing
Flow diagram: Shows participant flow and test results
Where to access: https://www.equator-network.org/reporting-guidelines/stard/
TRIPOD - Prediction Model Studies
Full name: Transparent Reporting of a multivariable prediction model for Individual Prognosis Or Diagnosis
When to use: Studies developing, validating, or updating prediction models
Latest version: TRIPOD 2015
Types of studies: - Model development only - Model development with validation - External validation of existing model - Model update
Main checklist items (22 items): 1. Title identifies study as prediction model study 2. Abstract summarizes key elements 3. Background and objectives 4. Data source and participants 5. Outcome definition 6. Predictors (candidate and selected) 7. Sample size justification 8. Missing data handling 9. Model building procedure 10. Model specification (equation or algorithm) 11. Model performance measures 12. Risk groups if used 13. Participant flow diagram 14. Model development results 15. Model performance 16. Model updating if applicable
Where to access: https://www.tripod-statement.org/
ARRIVE - Animal Research
Full name: Animal Research: Reporting of In Vivo Experiments
When to use: All in vivo animal studies
Latest version: ARRIVE 2.0 (2020 update)
Two sets of items:
ARRIVE Essential 10 (minimum requirements): 1. Study design 2. Sample size calculation 3. Inclusion and exclusion criteria 4. Randomization 5. Blinding 6. Outcome measures 7. Statistical methods 8. Experimental animals (species, strain, sex, age) 9. Experimental procedures 10. Results and interpretation
ARRIVE Recommended Set (additional items for full reporting): - Abstract, background, objectives - Ethics statement - Housing and husbandry - Animal care and monitoring - Interpretation and generalizability - Protocol registration - Data access
Where to access: https://arriveguidelines.org/
CARE - Case Reports
Full name: CAse REport Guidelines
When to use: Case reports and case series
Latest version: CARE 2013
Main checklist items (13 items): 1. Title with "case report" 2. Abstract summarizing case 3. Introduction with case background 4. Patient information (demographics, primary concern) 5. Clinical findings 6. Timeline of events 7. Diagnostic assessment 8. Therapeutic intervention 9. Follow-up and outcomes 10. Discussion with strengths and limitations 11. Patient perspective 12. Informed consent
Where to access: https://www.care-statement.org/
SQUIRE - Quality Improvement Studies
Full name: Standards for QUality Improvement Reporting Excellence
When to use: Healthcare quality improvement reports
Latest version: SQUIRE 2.0 (2015)
Main sections (18 items): 1. Title and abstract 2. Introduction (problem description, available knowledge, rationale, objectives) 3. Methods (context, intervention, study design, measures, analysis, ethical review) 4. Results (intervention, outcomes) 5. Discussion (summary, interpretation, limitations, conclusions) 6. Other information (funding)
Where to access: http://www.squire-statement.org/
CHEERS - Economic Evaluations
Full name: Consolidated Health Economic Evaluation Reporting Standards
When to use: Health economic evaluations
Latest version: CHEERS 2022 (major update from 2013)
Main checklist items (28 items): 1. Title identification as economic evaluation 2. Abstract 3. Background and objectives 4. Target population and subgroups 5. Setting and location 6. Study perspective 7. Comparators 8. Time horizon 9. Discount rate 10. Selection of outcomes 11. Measurement of effectiveness 12. Measurement and valuation of costs 13. Currency and price adjustments 14. Choice of model 15. Assumptions 16. Analytical methods
Where to access: https://www.equator-network.org/reporting-guidelines/cheers/
SRQR - Qualitative Research
Full name: Standards for Reporting Qualitative Research
When to use: Qualitative and mixed methods research
Latest version: SRQR 2014
Main sections: - Title and abstract - Introduction (problem formulation, purpose) - Methods (qualitative approach, researcher characteristics, context, sampling strategy, ethical issues, data collection, data analysis, trustworthiness) - Results (synthesis and interpretation, links to empirical data) - Discussion (limitations, implications)
Alternative: COREQ (Consolidated criteria for reporting qualitative research) for interviews and focus groups
Where to access: https://www.equator-network.org/reporting-guidelines/srqr/
How to Use Reporting Guidelines
During Study Planning
- Identify relevant guideline based on study design
- Review checklist items that require planning (e.g., randomization, blinding)
- Design study to ensure all required elements will be captured
- Consider protocol guidelines (e.g., SPIRIT for trials)
During Manuscript Drafting
- Download checklist from guideline website
- Work through each item systematically
- Note where each item is addressed in manuscript (page/line numbers)
- Revise manuscript to include missing items
- Use flow diagrams as appropriate
Before Submission
- Complete formal checklist with page numbers
- Review all items are adequately addressed
- Include checklist with submission if journal requires
- Note guideline adherence in cover letter or methods
Example Checklist Entry
Item 7: Eligibility criteria for participants, and the settings and locations where the data were collected
Page 6, lines 112-125: "Participants were community-dwelling adults aged 60-85 years with mild cognitive impairment (MCI) as defined by Petersen criteria. Exclusion criteria included dementia diagnosis, major psychiatric disorders, or unstable medical conditions. Recruitment occurred from three memory clinics in Boston, MA, between January 2022 and December 2023."
Finding the Right Guideline
EQUATOR Network Search
Website: https://www.equator-network.org/
How to use: 1. Select your study design from the wizard 2. Browse by health research category 3. Search for specific keywords 4. Filter by guideline status (development stage)
By Study Design
| If your study is a... | Use this guideline |
|---|---|
| Randomized controlled trial | CONSORT |
| Cohort, case-control, or cross-sectional study | STROBE |
| Systematic review or meta-analysis | PRISMA |
| Protocol for a trial | SPIRIT |
| Diagnostic accuracy study | STARD |
| Prediction model study | TRIPOD |
| Animal study | ARRIVE |
| Case report | CARE |
| Quality improvement study | SQUIRE |
| Economic evaluation | CHEERS |
| Qualitative research | SRQR or COREQ |
Multiple Guidelines
Some studies may require multiple guidelines:
Example 1: Pilot RCT with qualitative component - CONSORT for quantitative arm - SRQR for qualitative component
Example 2: Systematic review of diagnostic tests - PRISMA for review methods - STARD considerations for included studies
Extensions and Adaptations
Many reporting guidelines have extensions for specific contexts:
CONSORT Extensions (examples)
- CONSORT for Abstracts: Structured abstracts for RCT reports
- CONSORT for Harms: Reporting adverse events
- CONSORT-EHEALTH: eHealth interventions
- CONSORT-SPI: Social and psychological interventions
PRISMA Extensions (examples)
- PRISMA-P: Protocols for systematic reviews
- PRISMA for Abstracts: Conference abstracts
- PRISMA-NMA: Network meta-analyses
- PRISMA-IPD: Individual patient data reviews
- PRISMA-S: Search strategies
- PRISMA-DTA: Diagnostic test accuracy reviews
STROBE Extensions (examples)
- STROBE-ME: Molecular epidemiology
- RECORD: Routinely collected health data
Creating Flow Diagrams
CONSORT Flow Diagram
Four stages: 1. Enrollment: Assessed for eligibility 2. Allocation: Randomly assigned to groups 3. Follow-up: Received intervention, lost to follow-up 4. Analysis: Included in analysis
Example:
Assessed for eligibility (n=250)
↓
Excluded (n=50)
• Did not meet criteria (n=30)
• Declined to participate (n=15)
• Other reasons (n=5)
↓
Randomized (n=200)
├─────────────────┬─────────────────┐
↓ ↓ ↓
Allocated to Allocated to Allocated to
Intervention A Intervention B Control
(n=67) (n=66) (n=67)
↓ ↓ ↓
Lost to follow-up Lost to follow-up Lost to follow-up
(n=3) (n=5) (n=2)
↓ ↓ ↓
Analyzed Analyzed Analyzed
(n=64) (n=61) (n=65)
PRISMA Flow Diagram
Stages: 1. Identification: Records from databases and registers 2. Screening: Records screened, excluded 3. Included: Studies included in review and synthesis
New features in PRISMA 2020: - Separate tracking for database and register searches - Tracking of duplicate removal - Clear distinction between reports and studies
Common Mistakes and How to Avoid Them
Mistake 1: Not Using Guidelines at All
Impact: Missing critical information, lower chance of acceptance
Solution: Identify and use appropriate guideline from study planning stage
Mistake 2: Using Guidelines Only After Manuscript is Complete
Impact: May realize key data were not collected or documented
Solution: Review guidelines during study design and data collection
Mistake 3: Incomplete Checklist Completion
Impact: Missed items remain unreported
Solution: Systematically address every single checklist item
Mistake 4: Using Outdated Guidelines
Impact: Missing recent improvements in reporting standards
Solution: Always check for latest version on official guideline website
Mistake 5: Using Wrong Guideline for Study Design
Impact: Important design-specific elements not reported
Solution: Carefully match study design to appropriate guideline
Mistake 6: Not Submitting Checklist When Required
Impact: Editorial desk rejection or delays
Solution: Check journal submission guidelines and include checklist
Mistake 7: Generic Reporting Without Specificity
Impact: Insufficient detail for replication or appraisal
Solution: Provide specific, detailed information for each item
Journal Requirements
Many Journals Now Require:
- Statement of adherence to reporting guidelines in Methods
- Completed checklist uploaded as supplementary file
- Page/line numbers on checklist indicating where items are addressed
- Flow diagrams as figures in manuscript
Example Methods Statement:
"This study is reported in accordance with the Strengthening the Reporting of
Observational Studies in Epidemiology (STROBE) statement. A completed STROBE
checklist is provided as Supplementary File 1."
Journals with Strong Requirements:
- PLOS journals (require checklists for specific designs)
- BMJ (requires CONSORT, PRISMA, and others)
- The Lancet (requires adherence statements)
- JAMA and JAMA Network journals (require checklists)
- Nature portfolio journals (encourage guidelines)
Resources
Official Guideline Websites
- EQUATOR Network: https://www.equator-network.org/
- CONSORT: http://www.consort-statement.org/
- STROBE: https://www.strobe-statement.org/
- PRISMA: http://www.prisma-statement.org/
- SPIRIT: https://www.spirit-statement.org/
- ARRIVE: https://arriveguidelines.org/
- CARE: https://www.care-statement.org/
Training Materials
- EQUATOR Network provides webinars and training resources
- Many guidelines have explanatory papers published in medical journals
- Universities often provide workshops on reporting guidelines
Software Tools
- Some reference managers can insert reporting guideline citations
- Covidence, RevMan for systematic review reporting
- PRISMA flow diagram generator: http://prisma.thetacollaborative.ca/
Checklist: Using Reporting Guidelines
Before starting your study: - [ ] Identified appropriate reporting guideline(s) - [ ] Reviewed checklist items requiring prospective planning - [ ] Designed study to capture all required elements - [ ] Registered protocol if applicable
During manuscript drafting: - [ ] Downloaded latest version of guideline checklist - [ ] Systematically addressed each checklist item - [ ] Created required flow diagram - [ ] Noted where each item is addressed (page/line)
Before submission: - [ ] Completed formal checklist with page numbers - [ ] Verified all items adequately addressed - [ ] Included adherence statement in Methods - [ ] Prepared checklist as supplementary file if required - [ ] Checked journal-specific requirements - [ ] Mentioned guideline adherence in cover letter
Venue-Specific Reporting Requirements
Reporting Standards by Venue Type
| Venue Type | Guideline Use | Transparency Requirements |
|---|---|---|
| Medical journals | Mandatory (CONSORT, STROBE, etc.) | Checklist required at submission |
| PLOS/BMC | Mandatory for study types | Checklist uploaded as supplement |
| Nature/Science | Recommended | Methods completeness emphasized |
| ML conferences | No formal guidelines | Reproducibility details required |
ML Conference Reporting Standards
NeurIPS/ICML/ICLR reproducibility requirements: - Datasets: Names, versions, access methods, preprocessing - Code: Availability statement; GitHub common - Hyperparameters: All settings reported (learning rate, batch size, etc.) - Seeds: Random seeds for reproducibility - Computational resources: GPUs used, training time - Statistical significance: Error bars, confidence intervals, multiple runs - Broader Impact statement (NeurIPS): Societal implications
What to include (typically in appendix): - Complete hyperparameter settings - Training details and convergence criteria - Hardware specifications - Software versions (PyTorch 2.0, etc.) - Dataset splits and any preprocessing - Evaluation metrics and protocols
Enforcement and Evaluation
What gets checked: - Medical journals: Checklist uploaded; adherence statement in Methods; systematic completeness - PLOS/BMC: Mandatory checklists for certain designs; reproducibility emphasized - High-impact: Methods sufficiency for replication (checklist often not required) - ML conferences: Reproducibility checklist (NeurIPS); code availability increasingly expected
Common issues leading to rejection: - Missing required checklists (medical journals) - Insufficient methods detail for reproduction - Missing key information (randomization, blinding, power calculation) - No data/code availability statement when required
Methods statement examples:
Journal (STROBE):
This study followed STROBE reporting guidelines. Checklist provided in Supplement 1.
ML conference (reproducibility):
Code available at github.com/user/project. All hyperparameters in Appendix A.
Training used 4×A100 GPUs (~20 hours). Seeds: {42, 123, 456}.
Pre-Submission Reporting Checklist
For clinical trials (medical journals): - [ ] CONSORT checklist complete with page numbers - [ ] Trial registration number in abstract and methods - [ ] CONSORT flow diagram included - [ ] Statistical analysis plan described - [ ] Adherence statement in Methods
For observational studies (medical/epidemiology): - [ ] STROBE checklist complete - [ ] Study design clearly stated - [ ] Statistical methods detailed - [ ] Confounders addressed - [ ] Adherence statement in Methods
For systematic reviews: - [ ] PRISMA checklist complete - [ ] PRISMA flow diagram included - [ ] Protocol registered (PROSPERO) - [ ] Search strategy documented - [ ] Risk of bias assessment included
For ML conference papers: - [ ] All datasets named with versions - [ ] Code availability stated (GitHub link if available) - [ ] Hyperparameters listed (appendix acceptable) - [ ] Random seeds reported - [ ] Computational resources specified - [ ] Error bars/confidence intervals shown - [ ] Broader Impact statement (if required)