技能 临床研究报告标准与指南

临床研究报告标准与指南

v20260724
jama-reporting-standards
本指南详细绘制了不同研究设计(如随机对照试验、观察性研究、系统综述)与强制报告标准(如CONSORT、PRISMA、STROBE等)之间的对应关系。它帮助研究人员确保投稿的学术严谨性,达到顶级医学期刊的报告要求。
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概览

Reporting Standards (jama-reporting-standards)

When to trigger

  • You know the design and need the matching EQUATOR checklist
  • A flow diagram is missing (participant flow for RCTs, study selection for reviews)
  • You are unsure which guideline applies (CONSORT vs STROBE vs PRISMA vs STARD)
  • Preparing the checklist file required at submission

Design → guideline map

Design EQUATOR guideline Mandatory diagram
Randomized clinical trial CONSORT CONSORT participant-flow diagram
Observational (cohort, case-control, cross-sectional) STROBE Participant-flow diagram strongly expected
Systematic review ± meta-analysis PRISMA PRISMA study-selection flow diagram
Diagnostic-accuracy study STARD STARD participant-flow diagram
Study protocol SPIRIT Schedule of enrollment/assessments
Prediction model TRIPOD
Quality-improvement study SQUIRE
Other designs The matching EQUATOR guideline per guideline

Always check the EQUATOR Network and JAMA's Instructions for Authors for the current guideline list and any JAMA-specific extensions or required checklist file.

What each core guideline forces you to report

CONSORT (RCTs)

  • Title states "randomized"; structured abstract follows CONSORT-for-abstracts
  • Trial design, allocation ratio, eligibility, settings; any changes after start
  • Randomization (sequence, concealment, implementation) and blinding
  • Numbers randomized, received intervention, analyzed, and lost — in the flow diagram
  • Primary/secondary outcomes with estimated effect size and precision (CI)
  • Harms, registration number, protocol availability, funding

STROBE (observational)

  • Study design stated early; setting, eligibility, sources, follow-up
  • All variables (outcomes, exposures, confounders, effect modifiers) defined
  • Bias mitigation, sample-size logic, statistical methods incl. confounding
  • Numbers at each stage, descriptive data, and unadjusted and adjusted estimates

PRISMA (systematic reviews / meta-analyses)

  • Protocol/registration; explicit eligibility and information sources
  • Full reproducible search strategy; selection and data-extraction process
  • Risk-of-bias methods; synthesis methods; the study-selection flow diagram
  • Certainty-of-evidence assessment (e.g., GRADE)

STARD (diagnostic accuracy)

  • Index test and reference standard with rationale and thresholds
  • Participant flow and timing; cross-tabulation of results vs reference
  • Estimates of accuracy with CIs; handling of indeterminate results

Checklist

  • Correct guideline chosen for the design
  • Completed checklist file prepared with page/line numbers for each item
  • Required flow diagram drafted (CONSORT / PRISMA / STARD / STROBE)
  • Title and abstract conform to the abstract-level extension where one exists
  • Registration number and protocol availability reported where required
  • Adjusted and unadjusted estimates both reported (observational)
  • Certainty-of-evidence / risk-of-bias reported (reviews, observational)

Anti-patterns

  • Submitting an RCT with no CONSORT flow diagram
  • A systematic review with no PRISMA diagram or no reproducible search
  • Filling the checklist with page numbers that do not match the text
  • Picking STROBE for a randomized trial (or CONSORT for a cohort)
  • Reporting only adjusted estimates in an observational study
  • Ignoring the abstract-level extension (e.g., CONSORT-for-abstracts)

Worked example: matching design to checklist (illustrative)

Vignette (illustrative): a multicenter randomized clinical trial, N = 2,800 adults with sepsis, primary outcome 90-day mortality, absolute risk difference -3.1 percentage points (95% CI, -5.8 to -0.4). At the Journal of the American Medical Association this maps to CONSORT with a mandatory participant-flow diagram accounting for everyone screened, randomized, and analyzed; the completed CONSORT checklist must carry page/line locations, the title must state "randomized," and the abstract follows CONSORT-for-abstracts. Had the same question been answered by a cohort, the map would shift to STROBE with both unadjusted and adjusted estimates; a systematic review would shift to PRISMA with a study-selection diagram and a GRADE certainty assessment.

Reviewer pushback and the JAMA fix

  • "Reporting incomplete (CONSORT/PRISMA item X)." Fix: add the item and update the checklist's page/line location to match the revised text.
  • "Picked STROBE for a randomized trial." Fix: re-map to CONSORT; the design, not convenience, fixes the guideline.
  • "Only adjusted estimates reported (observational)." Fix: report unadjusted and adjusted estimates per STROBE.

Calibration anchors (hedge where uncertain): the design-to-guideline mapping and the mandatory flow diagram for RCTs and reviews are durable; JAMA-specific extensions and required checklist files evolve — confirm against the EQUATOR Network and current author guidelines.

Reporting pass for JAMA

Run this as a concrete capability pass. First lock the clinical question, patient population, estimand or endpoint, safety/ethics issue, and reporting checklist; then test whether the manuscript addresses clinical reviewers who ask whether the evidence changes patient care, policy, or medical decision-making while satisfying reporting standards.

  • Primary move: Tie every reporting checklist item to a manuscript location; missing registration, denominator, consent, data, or code statements must be explicit blockers.
  • Decision ledger: return claim / evidence / blocker / next edit rows so the next pass can patch the manuscript directly.
  • Sibling comparison: compare against NEJM for field-changing clinical medicine, Lancet for global-health breadth, specialty journals for narrower clinical domains; if the neighboring outlet has the stronger audience claim, recommend re-routing before polishing.
  • Verification floor: before submission-ready advice, re-open resources/official-source-map.md for volatile rules and name the one unresolved fact that could change the recommendation.

Output format

【Design】...
【Guideline】CONSORT / STROBE / PRISMA / STARD / other
【Flow diagram drafted】yes / no
【Checklist file complete with locations】yes / no
【Items still unreported】...
【Next skill】jama-statistics
信息
Category 未分类
Name jama-reporting-standards
版本 v20260724
大小 7.04KB
更新时间 2026-07-28
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