nejm-submission

name	nejm-submission
description	Use as the final preflight before submitting to NEJM — a complete clinical checklist across significance, registration, reporting guidelines, abstract, statistics, display items, ethics, references, and required files. Bundles a checklist and a clinical cover-letter template.

Submission Preflight (nejm-submission)

When to trigger

• The manuscript is "done" and you're about to upload.
• You want a single gate that confirms every other nejm-* skill's output landed.
• A revision is going back and you need to confirm nothing regressed.

Master preflight checklist

Significance & venue

• Clears the practice-changing / clinical-impact bar (nejm-fit rung ≥ 4; all three gates).
• Patient-important primary outcome (not surrogate-only).
• Article type chosen (Original Article / Brief Report) and within its length/reference caps.

Registration, protocol & SAP

• Trial prospectively registered (ClinicalTrials.gov / WHO ICTRP) before enrollment; registration number in hand.
• Registered primary outcome matches the reported primary outcome.
• Protocol and statistical analysis plan finalized, dated, and ready as a supplement.

Reporting guidelines

• Correct EQUATOR guideline (CONSORT / STROBE / PRISMA, + any extension) with completed checklist.
• CONSORT participant flow diagram (RCT) / PRISMA selection diagram (SR-MA) present.
• Flow-diagram numbers reconcile with Table 1 and the analysis populations.

Abstract

• Structured, four sections (Background / Methods / Results / Conclusions), ≤250 words.
• Primary outcome with effect estimate + 95% CI; ITT and per-group n stated.
• Registration number and funding source in the abstract.

Statistics

• CIs reported with effect estimates (not P alone); exact P values.
• ITT primary analysis; per-protocol as sensitivity (both for non-inferiority).
• Multiplicity controlled; exploratory endpoints labeled.
• Subgroups pre-specified with interaction tests (forest plot).
• Absolute risk + NNT alongside relative measures; missing-data handling stated.

Display items

• Table 1 by group, no baseline P values (standardized differences if used).
• Kaplan–Meier with numbers-at-risk; forest plots for subgroups/meta.
• Figures de-identified; CIs shown; colorblind-safe; standalone legends.

Ethics & integrity

• IRB/ethics approval + informed consent stated; Declaration of Helsinki / GCP.
• ICMJE disclosure forms for all authors; competing-interests statement.
• ICMJE authorship criteria met; contributors acknowledged; medical writers disclosed.
• Role-of-the-funding-source statement; data access/vouching for sponsored trials.
• Data-sharing statement (ICMJE) — what / when / to whom / how.

References

• Vancouver / ICMJE numbered style, ordered by appearance.
• First six authors then et al.; NLM journal abbreviations; within reference cap.
• All in-text superscript numbers resolve; no gaps/duplicates.

Required files & metadata

• Main text (title page, structured abstract, IMRAD, references).
• Figures + legends; tables (incl. Table 1) and the CONSORT flow diagram.
• Supplementary appendix: protocol + SAP, supp tables/figures.
• Cover letter (clinical importance + what's practice-changing).
• Authors, affiliations, ORCIDs, corresponding author; CRediT/contributions.
• Completed reporting checklist (CONSORT/STROBE/PRISMA).
• Disclosure forms; data-sharing statement; funding statement.

Final integrity sweep

• No over-claiming beyond the evidence (re-read abstract Conclusions and Discussion).
• Causal language only where the design supports it (cautious for observational).
• Registration number, denominators, and primary-outcome numbers consistent across abstract, text, tables, and flow diagram.
• Single-blind convention assumed unless instructed otherwise (confirm).

Templates

• templates/checklist.md — copyable clinical preflight checklist.
• templates/cover_letter_template.md — clinical cover-letter scaffold.

Submission readiness pass for New England Journal of Medicine

Use this as a second-pass capability check. First lock the clinical question, population, endpoint, effect size, safety signal, and practice implication; then test whether the manuscript addresses clinical-medicine reviewers who expect practice-changing evidence, patient relevance, safety, and exact reporting discipline.

• Primary move: Verify portal, article type, anonymity, declarations, files, data/code, and current source-map facts; return blockers before formatting advice.
• Decision ledger: return claim / evidence / blocker / next edit rows so the next pass can patch the manuscript directly.
• Neighbor test: compare against JAMA for broad clinical medicine, Lancet for global-health/public-health reach, specialty journals for narrower disease 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

【Blocking gaps】 [...]  (must fix before upload — e.g., unregistered trial, missing CONSORT diagram)
【Warnings】 [...]       (should fix)
【Files ready】 main / figures+tables / CONSORT diagram / protocol+SAP / cover letter / disclosures / data-sharing
【Verdict】 GO / NO-GO + the top 3 fixes
【Next】 submit | nejm-rebuttal (after decision)

Anti-patterns

• Do not upload a trial that was never prospectively registered without flagging it as a blocker.
• Do not submit an RCT without the CONSORT flow diagram and completed checklist.
• Do not omit the data-sharing statement or the role-of-the-funding-source statement.
• Do not rely on memory; run the checklist top to bottom.