Field: Medicine

A field overlay: it supplements, not replaces, the general agent_docs. Read it before discipline-specific writing. It encodes the conventions and reviewer expectations of clinical journals so the agent does not write basic-science prose into an NEJM submission, applies the right reporting guideline, and never overstates a benefit a trial does not support.

Activate it in CLAUDE.project.md → Field overlay.

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Venues & where content goes

• Main text vs supplement: the primary outcome analysis, the CONSORT/STROBE flow, and the key safety data go in the main text; the full protocol, statistical analysis plan (SAP), additional subgroups, and detailed adverse-event tables go to the supplementary appendix.
• Mandatory at submission: the reporting-guideline checklist, the trial-registration number, an ethics/IRB statement, and conflict-of-interest + funding disclosures. Editors desk-check these.

Reporting guidelines (match the study type — EQUATOR network)

The single cheapest way to not miss a required element; journals require the completed checklist (agent_docs/reproducibility.md).

These are checklists, not prose generators. Run the relevant one before submission; a missing item is a reviewer comment you can pre-empt.

Structure (IMRaD + structured abstract)

A typical layout: structured abstract → Introduction → Methods → Results → Discussion.

• Structured abstract: Background, Methods, Results, Conclusions (journal-specific headings); the primary outcome with its effect estimate and CI appears here and must match the body (verification step 4, CLAUDE.md).
• Methods name the design, registration, setting, eligibility, intervention/exposure, the prespecified primary outcome, sample-size calculation, randomization/blinding, and the analysis plan (ITT). Written to enable appraisal and repetition (agent_docs/reproducibility.md).
• Discussion opens with the principal findings, then comparison with prior evidence, limitations, and a calibrated clinical implication — not a recommendation the data do not support.

Trial registration (prospective — a hard gate)

ICMJE journals will not publish an unregistered trial.

• Register on ClinicalTrials.gov, ISRCTN, or a WHO-ICTRP primary registry before enrolling the first participant (prospective registration). State the registration number and date in the abstract and Methods.
• The registered primary outcome is binding. Report it as the primary outcome; any change from the registered/protocol outcome must be disclosed and justified. Switching the primary outcome to a "significant" secondary one is outcome-switching — a documented integrity problem reviewers and watchdogs check.
• The kit does not invent an NCT/ISRCTN number or registration date — [VALUE — verify] if unknown, never a plausible-looking ID (CLAUDE.md → Source-Grounded Writing).

Ethics (state it explicitly)

• IRB / research-ethics-committee approval with the approving body and protocol number.
• Informed consent obtained (and the process for vulnerable populations / waivers).
• Conducted per the Declaration of Helsinki (and ICH-GCP for trials) — state it.
• The ethics statement is a dedicated Methods subsection; approval IDs follow the no-fabrication rule.

Effect measures (report clinically, not just p)

A p-value is not a result; clinicians need the size and precision of the effect (agent_docs/statistics.md).

Do not report a relative risk reduction without its absolute counterpart, and do not call a result "significant" as a synonym for "large" (agent_docs/academic-style.md).

Bias & internal validity

• Randomization & allocation concealment: describe the sequence generation and that allocation was concealed (concealment ≠ blinding) — inadequate concealment exaggerates effects.
• Blinding: who was blinded (participants, clinicians, outcome assessors, analysts); if open-label, how outcome assessment was protected.
• Attrition & missing data: report dropout by arm and how missing data were handled (e.g. multiple imputation); differential attrition threatens validity.
• CONSORT flow diagram: enrollment → allocation → follow-up → analysis, with numbers and reasons for loss at each stage. Mandatory for RCTs; the numbers must reconcile with the text (verification step 4, CLAUDE.md).
• For observational designs, address confounding (adjustment, matching, sensitivity analyses) — and do not let adjustment masquerade as causal proof.
• Subgroups are prespecified or exploratory. A treatment effect in a subgroup is interpretable only if the subgroup was prespecified and tested with an interaction term; a post-hoc subgroup "win" is hypothesis-generating, not confirmatory (agent_docs/statistics.md). State how many subgroups were examined.
• Multiplicity: with multiple endpoints or interim analyses, report the alpha-spending or correction; do not present the one endpoint that crossed significance as if it stood alone.

Calibration in this field (overclaim → calibrated)

The verb/scope ladder of agent_docs/academic-style.md, applied to clinical writing:

Pattern: pair relative with absolute effects and CIs, scope to the trial population/outcome, and never call a secondary or subgroup result confirmatory.

Conflicts of interest, funding & data privacy

• COI + funding disclosure: all financial and non-financial conflicts and the funding source, with the funder's role in design/analysis/reporting (ICMJE form). Required, not optional.
• Patient-data privacy: de-identify; no identifying details/images without explicit consent for publication; comply with HIPAA/GDPR as applicable. Individual-participant-data sharing per a stated plan (ICMJE data-sharing statement).
• Trial data/SAP deposit where required; the deposit/registration identifiers are real — [VALUE — verify] until they exist (block-fabrication.sh).

Evidence hierarchy & terminology

• Calibrate the claim to the design. Ascending strength: case report < case series < cross-sectional < case-control < cohort < RCT < systematic review/meta-analysis of RCTs. A single observational study does not license a treatment recommendation.
• One term per concept (MANUSCRIPT_MAP.md → Terminology): do not alternate "adverse event" / "side effect" / "complication" if they are defined differently; fix "efficacy" (ideal conditions) vs "effectiveness" (real-world) and hold it.
• Units & symbols per agent_docs/statistics.md; brace-protect acronyms in BibTeX titles — {RCT}, {COVID-19}, {HbA1c}.
• Citation style: Vancouver/ICMJE numbered references is the norm; cite the published trial report and its registration, and cite primary trials rather than reviews for a specific efficacy claim (CLAUDE.md → Source-Grounded Writing).
• Common knowledge for a clinical readership needs no citation; calibrate to the journal's audience.
• Outcome definitions are stated and held constant — a composite endpoint lists its components, and "response" / "remission" carry their prespecified thresholds, used identically throughout.

Typical reviewer concerns (pre-empt them)

MANUSCRIPT_MAP.md additions for medical papers

Add to your map's Claims that need extra care:

• A statistically significant secondary or subgroup outcome is hypothesis-generating, not confirmatory — do not promote it to the headline finding.
• A relative effect without its absolute counterpart (and CI) overstates clinical benefit.
• Efficacy in a trial population does not establish effectiveness or safety in routine care or untested populations — scope the claim.
• An observational association does not license a causal or treatment-recommendation claim regardless of adjustment.

Add to Data & reproducibility: the reporting guideline in force (CONSORT / STROBE / PRISMA / STARD / SPIRIT), the trial-registration number and date (or [VALUE — verify]), the prespecified primary outcome and analysis (ITT), IRB approval + consent + Declaration of Helsinki, COI/funding disclosures, and the data-sharing statement.