Study-Reporting Guidelines

Reporting guidelines turn the reader's appraisal needs into a structured set of items. The writer uses them twice: first to build the document architecture, then to verify the completed report.

Use a reporting guideline at outline stage

Select the guideline from the actual design, not from the title the team hopes to use. Retrieve the main checklist, explanatory material, flow diagram where relevant, and any extension that fits the intervention, outcome, population, data source, or format. Map every applicable item to a section, display, supplement, or explicit not-applicable decision.

Do not paste checklist language into the manuscript. Convert the requirement into a question the section must answer. For example, a requirement concerning participant flow becomes an instruction to define the populations, describe movement through the study, account for exclusions and losses, and reconcile the narrative with the flow diagram and analysis sets.

Use it again at final review

Complete the target's required checklist against the final pagination or section identifiers. Check the manuscript, supplement, registry, protocol, and referenced companion documents together. A page number beside an item proves only that the writer pointed somewhere; it does not prove the required information is complete.

Randomized trials: CONSORT family

For a randomized trial, readers need to understand the question, design, participants, interventions, outcomes, sample-size rationale, randomization, allocation concealment, blinding, statistical methods, participant flow, recruitment, baseline data, analyzed numbers, outcomes and estimation, harms, limitations, generalizability, interpretation, registration, protocol access, and funding.

The writer should pay particular attention to distinctions that vague prose erases:

• sequence generation versus allocation concealment;
• who was blinded, to what, and how blinding was maintained;
• prespecified versus changed or post-hoc outcomes;
• enrolled, randomized, treated, completed, and analyzed populations;
• effect estimates and uncertainty versus declarations based only on significance;
• adverse-event reporting versus selective mention of expected events;
• trial interpretation versus claims about routine practice or individuals.

Use the flow diagram as a reconciliation instrument. Every count and reason should agree with the source data, tables, and text.

Protocols: SPIRIT family

A protocol reporting guideline helps make planned research understandable before results exist. It covers administrative information, rationale, objectives, design, participants, interventions, outcomes, timeline, sample size, recruitment, allocation, blinding, data collection and management, analysis, monitoring, harms, auditing, ethics, confidentiality, dissemination, access to data, and appendices such as consent materials.

For a protocol manuscript, report the scientific plan and governance transparently. For an operational regulated protocol, applicable regulatory and organizational requirements also control the document. The reporting guideline does not replace the controlled protocol template or authority expectations.

Observational research: STROBE family

Observational reports must make design and selection visible enough for readers to judge bias, confounding, measurement, missing data, and generalizability. State the design early. Define setting, dates, eligibility, exposure, outcome, predictors, confounders, effect modifiers, data sources, measurement methods, efforts to address bias, study size, variable handling, and statistical methods.

Report participant numbers across relevant stages, reasons for non-participation where available, descriptive characteristics, missingness, outcome data, estimates with precision, adjusted and unadjusted results when meaningful, category boundaries, sensitivity analyses, and limitations. Do not convert association into causation through verbs or headline claims.

For routinely collected data and real-world evidence, document provenance, coding, linkage, quality, completeness, algorithm definitions, observation windows, and fit for the research purpose. Specialized extensions may add the details needed for databases, registries, or other data sources.

Systematic reviews and meta-analyses: PRISMA family

A systematic review is reproducible evidence research, not a long narrative with many citations. Report the question and eligibility criteria, information sources, complete search strategies where required, selection process, data collection, data items, risk-of-bias assessment, effect measures, synthesis methods, heterogeneity assessment, reporting-bias assessment, certainty evaluation where used, protocol or registration, amendments, support, competing interests, and data availability.

The flow diagram must reconcile records identified, removed before screening, screened, excluded, sought, assessed, excluded with reasons, and included. Results should connect study characteristics, individual-study findings, risk of bias, syntheses, heterogeneity, sensitivity analyses, and certainty. The Discussion should distinguish the limitations of the evidence from the limitations of the review process.

A meta-analysis adds statistical obligations; it does not automatically repair heterogeneity, bias, or incompatible outcomes. Explain model choices and transformations, show uncertainty, and avoid treating a pooled number as more credible than its contributing evidence.

Case reports: CARE family

A case report needs a clear clinical lesson supported by a transparent chronology. Describe patient information without unnecessary identifiers, clinical findings, timeline, diagnostic assessment, therapeutic intervention, follow-up and outcomes, adverse or unanticipated events, and the patient's perspective or consent where applicable. Explain why the case is noteworthy without claiming frequency, causality, or generalizability that one case cannot establish.

Privacy is a design constraint. Removing a name may not de-identify a rare or richly described case. Follow the applicable consent, institutional, target, and legal requirements.

Other designs and extensions

Diagnostic-accuracy studies, prediction models, economic evaluations, quality-improvement work, qualitative research, animal or preclinical research, routinely collected data, pragmatic trials, cluster trials, noninferiority trials, harms, abstracts, and patient-reported outcomes may require dedicated guidance or extensions. The method remains:

1. identify the exact design and reporting claim;
2. retrieve the current main guideline and applicable extensions;
3. map items into the outline and displays;
4. document not-applicable decisions;
5. verify the final artifact and required checklist.