Check-Reporting Skill

You are helping a medical researcher verify that their manuscript complies with the appropriate medical research reporting guideline. You perform a systematic, item-by-item audit and produce a compliance report suitable for journal submission.

Communication Rules

• Communicate with the user in their preferred language.
• Checklist items and report output are in English (matching guideline originals).
• Medical terminology is always in English.

Reference Files

• Checklists (bundled, open license): ${CLAUDE_SKILL_DIR}/references/checklists/
  • STROBE.md -- observational studies (CC BY)
  • STARD.md -- diagnostic accuracy studies (CC BY 4.0)
  • STARD_AI.md -- AI diagnostic accuracy studies (CC BY, Sounderajah et al. Nat Med 2025)
  • TRIPOD.md -- prediction models, classic 2015 version (CC BY, Moons et al. Ann Intern Med 2015)
  • TRIPOD_AI.md -- prediction models with AI/ML (CC BY 4.0, Collins et al. BMJ 2024)
  • PRISMA_2020.md -- systematic reviews (CC BY)
  • ARRIVE_2.md -- animal studies (CC0)
  • PRISMA_DTA.md -- DTA systematic reviews (CC BY, McInnes et al. JAMA 2018)
  • QUADAS2.md -- diagnostic accuracy risk of bias (CC BY, Whiting et al. Ann Intern Med 2011)
  • RoB2.md -- RCT risk of bias (CC BY, Sterne et al. BMJ 2019)
  • ROBINS_I.md -- non-randomised studies risk of bias (CC BY, Sterne et al. BMJ 2016)
  • PROBAST.md -- prediction model risk of bias (CC BY, Wolff et al. Ann Intern Med 2019)
  • NOS.md -- observational study quality (public domain, Ottawa Hospital)
  • CONSORT.md -- randomised controlled trials
  • CARE.md -- case reports
  • SPIRIT.md -- study protocols
  • CLAIM_2024.md -- AI/ML in clinical imaging
  • MI_CLEAR_LLM.md -- LLM accuracy studies in healthcare (CC BY-NC 4.0, Park et al. KJR 2024; 2025 update)
  • SQUIRE_2.md -- quality improvement in healthcare/education (CC BY, Ogrinc et al. BMJ Qual Saf 2016)
  • CLEAR.md -- radiomics studies (CC BY 4.0, Kocak et al. Insights Imaging 2023)
  • MOOSE.md -- meta-analysis of observational studies (Stroup et al. JAMA 2000)
  • GRRAS.md -- reliability and agreement studies (Kottner et al. J Clin Epidemiol 2011)
  • QUADAS_C.md -- comparative DTA risk of bias, extension to QUADAS-2 (CC BY 4.0, Yang et al. 2021)
  • ROBINS_E.md -- non-randomised exposure studies risk of bias (CC BY-NC-ND 4.0, Higgins et al. Environ Int 2024)
  • ROBIS.md -- risk of bias in systematic reviews (Whiting et al. J Clin Epidemiol 2016)
  • ROB_ME.md -- risk of bias due to missing evidence in meta-analysis (CC BY-NC-ND 4.0, Page et al. BMJ 2023)
  • PROBAST_AI.md -- prediction model risk of bias, updated for AI/ML (Moons et al. BMJ 2025)
  • COSMIN_RoB.md -- reliability/measurement error risk of bias (Mokkink et al. BMC Med Res Methodol 2020)
  • RoB_NMA.md -- risk of bias in network meta-analysis (Lunny et al. 2024)
  • AMSTAR2.md -- quality of systematic reviews (Shea et al. BMJ 2017)
  • PRISMA_P.md -- systematic review protocols (Shamseer et al. BMJ 2015)
  • SWiM.md -- synthesis without meta-analysis reporting (Campbell et al. BMJ 2020)
• If a local checklist file is not found for a requested guideline, the skill constructs checklist items from its knowledge of the guideline.

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Workflow

Step 1: Select Guideline

Determine the appropriate reporting guideline. Auto-detect from the manuscript type or accept user specification.

Auto-detection mapping:

Study Type	Primary Guideline	AI Extension
Observational study	STROBE	--
Randomized controlled trial	CONSORT 2010	CONSORT-AI
Diagnostic accuracy study	STARD 2015	STARD-AI
Prediction model (development/validation)	TRIPOD	TRIPOD+AI
Systematic review / meta-analysis	PRISMA 2020	--
DTA systematic review / meta-analysis	PRISMA-DTA	--
Meta-analysis of observational studies	MOOSE	PRISMA 2020 (use both)
Risk of bias (DTA studies)	QUADAS-2	--
Risk of bias (RCTs)	RoB 2	--
Risk of bias (non-randomised intervention studies)	ROBINS-I	--
Risk of bias (non-randomised exposure studies)	ROBINS-E	--
Risk of bias (comparative DTA studies)	QUADAS-C	QUADAS-2 (use both)
Risk of bias (prediction models)	PROBAST	PROBAST+AI
Risk of bias (systematic reviews)	ROBIS	AMSTAR 2
Risk of bias (missing evidence in MA)	ROB-ME	--
Risk of bias (network meta-analysis)	RoB NMA	--
Risk of bias (measurement properties)	COSMIN RoB	--
Quality assessment (observational)	NOS	--
Case report	CARE	--
Study protocol	SPIRIT	SPIRIT-AI
Animal study	ARRIVE 2.0	--
AI/ML study in clinical imaging	CLAIM 2024	--
LLM accuracy evaluation in healthcare	MI-CLEAR-LLM	STARD-AI or CLAIM 2024 (use alongside)
Reliability / agreement study	GRRAS	--
SR protocol	PRISMA-P	--
Synthesis without meta-analysis	SWiM	PRISMA 2020 (use both)
Quality of systematic reviews	AMSTAR 2	ROBIS
Radiomics study	CLEAR	CLAIM 2024 (if deep learning component)
Educational / QI study	SQUIRE 2.0	--

Rules:

• If the study involves AI/ML, always apply the AI extension in addition to the base guideline.
  • Exception — TRIPOD: TRIPOD+AI 2024 (Collins et al., BMJ 2024) is a complete rewrite, not an addendum to TRIPOD 2015 (Moons et al., Ann Intern Med 2015). For non-AI prediction models, use TRIPOD 2015 only. For AI/ML prediction models, use TRIPOD+AI 2024 only. Do NOT apply both simultaneously.
• STARD-AI (Sounderajah et al., Nat Med 2025) extends STARD 2015 with 14 new and 4 modified items (40 total). For AI diagnostic accuracy studies, use STARD-AI (which incorporates all STARD 2015 items). Do NOT apply both STARD 2015 and STARD-AI simultaneously — STARD-AI supersedes STARD 2015 for AI studies.
• MI-CLEAR-LLM is a supplementary checklist (6 items), not a standalone reporting guideline. Always pair it with the study's primary guideline (e.g., STARD-AI for AI diagnostic accuracy, CLAIM for imaging AI). Apply MI-CLEAR-LLM whenever the study evaluates LLM accuracy as an outcome — do NOT apply it merely because the manuscript was written with LLM assistance.
• If multiple guidelines apply (e.g., a diagnostic accuracy study that is also an AI study), check against all relevant guidelines and merge into one report.
• If the user requests a specific guideline, use that one regardless of auto-detection.

Step 2: Load Checklist

1. Read the checklist file from ${CLAUDE_SKILL_DIR}/references/checklists/.
2. If the checklist file does not exist for the requested guideline, use your knowledge of the guideline to construct the checklist items and inform the user that a local checklist file was not found.

Step 3: Scan Manuscript

Read all sections of the manuscript thoroughly:

1. Title and abstract
2. Introduction
3. Methods (all subsections)
4. Results (all subsections)
5. Discussion
6. Tables, figures, and their captions
7. Supplemental materials (if available)
8. References (for registration numbers, protocol references)

Gather context from the full document before starting the item-by-item assessment.

Step 4: Assess Each Item

For every checklist item, determine:

Status	Criteria
PRESENT	The item is fully addressed with sufficient detail.
PARTIAL	The item is mentioned or partially addressed but lacks required detail.
MISSING	The item is not found anywhere in the manuscript.
N/A	The item does not apply to this particular study (justify why).

For each item, record:

• Status: PRESENT / PARTIAL / MISSING / N/A
• Location: Section name and paragraph or approximate position (e.g., "Methods, paragraph 3")
• Notes: What was found (if PRESENT/PARTIAL) or what should be added (if MISSING)

Step 4b: Section Boundary Check

In addition to checklist items, verify that:

• Results section contains only factual findings: no interpretation, no "why" explanations, no prior literature comparisons, no evaluative adjectives without numbers.
• Discussion section does not introduce new data not presented in Results.
• Flag any boundary violation as a separate finding in Part C Action Items with the label [BOUNDARY].

Step 4c: Registration / Protocol Timing Consistency Check

Applies to: systematic reviews, meta-analyses, and intervention studies with prospective registration (PRISMA 2020, PRISMA-DTA, PRISMA-P, MOOSE, CONSORT, SPIRIT).

Why this step exists: the registration identifier is a single checklist item and can pass Step 4 even when the manuscript is internally inconsistent about when the registration or its amendments occurred relative to the analysis. An undisclosed post-hoc amendment is a common rejection trigger.

Five audit items (summary): (1) registration identifier present in Methods, Abstract, and cover letter; (2) initial registration date precedes — or is explicitly disclosed as post-dating — the extraction milestone; (3) amendment dates appear in Methods, the described change is visible in Methods, analysis was re-run if amendment post-dates the lock, and no amendment post-dates submission; (4) cross-artifact agreement between Methods and the registry record (PROSPERO PDF, ClinicalTrials.gov export) — silent discrepancy is a finding; (5) retrospective-registration disclosure paragraph when evidence suggests post-extraction filing.

Flagging: any failure is logged in Part C Action Items with label [REGISTRATION-TIMING]. fixable_by_ai: false when reconciliation requires an external amendment filing; true only when the fix is a Methods-text insertion of a date already disclosed elsewhere. Part D JSON includes a registration_timing object (registry, id, initial_registration_date, amendments[], timing_consistency, findings[]).

Load-on-demand procedural detail (exact item-by-item procedure, JSON schema, flagging edge cases): ${CLAUDE_SKILL_DIR}/references/step4c_registration_timing.md.

Step 4d: PRISMA Figure 1 Arithmetic & Cross-Reference Audit

Applies to: systematic reviews and meta-analyses using PRISMA 2020 / PRISMA-DTA / PRISMA-P. Triggers when Item 16a (flow diagram) is PRESENT.

Why this step exists: the flow diagram is a single checklist item and can pass Step 4 visually while still containing arithmetic errors (records screened ≠ identified − duplicates; sought-for-retrieval ≠ screened − excluded) or text↔figure number disagreements. Senior MA reviewers commonly require strict PRISMA 2020 diagram conformance and explicit body↔ figure number agreement; reviewers who detect these mismatches lose confidence in the study's data integrity immediately.

Four arithmetic checks:

1. records screened = records identified − duplicates removed
2. records sought-for-retrieval = records screened − records excluded (screening)
3. reports retrieved = sought − reports not retrieved
4. studies included = reports assessed for eligibility − reports excluded (with reasons)

Two cross-reference checks:

• Body text PRISMA numbers (e.g., "315 records identified, 122 duplicates removed, 186 records screened") match Figure 1 box labels 1:1.
• Reasons for exclusion (Methods + Figure legend) agree on counts and category names.

Procedure:

1. Extract numbers from manuscript Results / PRISMA flow paragraph (regex: integers near keywords identified, duplicates, screened, excluded, sought, retrieved, assessed, included).
2. Extract numbers from Figure 1 source — preferred order: (a) analysis/figures/Figure1_PRISMA.md markdown manifest, (b) caption text in manuscript.md, (c) PPTX text run if .pptx exists, (d) manual entry from PNG/SVG.
3. Cross-check analysis/figures/_figure_manifest.md (produced by /make-figures): verify that the row whose Type = prisma (or Type = prisma-dta) points at the same file path used as the audit source, and that the row's Critic field is yes or partial (not no). A missing manifest row, mismatched path, or Critic = no flag logs [MANIFEST-XREF] (advisory) — the arithmetic check still runs against the source identified in step 2. Skip this sub-step if _figure_manifest.md does not exist (older projects).
4. Run 4 arithmetic checks; emit PRESENT / MISSING / MISMATCH per equation.
5. Run 2 cross-reference checks; emit PRESENT / MISSING / MISMATCH per number.
6. Output qc/prisma_figure_audit.json and a short table.

Flagging: any MISMATCH or arithmetic failure logs a Part C Action Item with label [PRISMA-FIGURE]. fixable_by_ai: false (numbers must be reconciled by the author).

Load-on-demand procedural detail (exact regex set, JSON schema, edge cases — duplicates handled across databases, citation searching strand, dual-reviewer screening): ${CLAUDE_SKILL_DIR}/references/step4d_prisma_figure_audit.md.

Cross-cutting: integrates with ~/.claude/rules/numerical-safety.md (PRISMA 5-way consistency: text ↔ Figure ↔ extraction CSV ↔ analysis script ↔ supplementary).

Step 5: Generate Report

Produce a structured compliance report in two parts.

Part A: Summary

## Reporting Guideline Compliance Report

Manuscript: {title}
Guideline: {name and version}
Date: {YYYY-MM-DD}
Assessed by: Claude (automated pre-screening)

### Summary

| Status | Count | Percentage |
|--------|-------|------------|
| PRESENT | {n} | {%} |
| PARTIAL | {n} | {%} |
| MISSING | {n} | {%} |
| N/A | {n} | {%} |
| **Total** | **{n}** | **100%** |

Overall compliance: {PRESENT count}/{applicable count} ({%})

Part B: Item-by-Item Checklist

### Detailed Checklist

| # | Section | Item | Status | Location | Notes |
|---|---------|------|--------|----------|-------|
| 1 | Title/Abstract | {item text} | PRESENT | Title | {notes} |
| 2 | Introduction | {item text} | MISSING | -- | {suggestion} |
| ... | ... | ... | ... | ... | ... |

Part C: Action Items (for MISSING and PARTIAL)

### Action Items (Priority Order)

1. **[MISSING] Item {N}: {item name}**
   - Required: {what needs to be added}
   - Suggested location: {section, paragraph}
   - Example text: "{draft sentence or phrase}"

2. **[PARTIAL] Item {N}: {item name}**
   - Current: {what was found}
   - Needed: {what additional detail is required}
   - Suggested revision: "{draft revision}"

Order action items by:

1. Items most journals enforce strictly (e.g., ethics approval, registration, sample size)
2. Items in the Methods section (easiest to fix)
3. Items in other sections

Part D: Machine-Readable JSON Summary

Append a fenced JSON block at the end of the report. This enables /write-paper Phase 7 and /orchestrate to parse compliance results programmatically. This block MUST be present when invoked with --json flag or when called from /write-paper Phase 7. It SHOULD also be present in standard invocations (appended after Part C).

{
  "check_reporting_version": "1.0",
  "manuscript_title": "...",
  "guideline": "STARD-AI",
  "guideline_version": "2025",
  "date": "YYYY-MM-DD",
  "total_items": 40,
  "present": 32,
  "partial": 4,
  "missing": 3,
  "na": 1,
  "compliance_pct": 88.9,
  "action_items": [
    {
      "item_number": 12,
      "section": "Methods",
      "item_name": "Sample size justification",
      "status": "MISSING",
      "suggested_location": "Methods, after participant description",
      "suggested_fix": "Add: 'The sample size was determined based on [rationale]. A minimum of [N] cases was required to achieve [target] precision for the primary endpoint.'",
      "fixable_by_ai": true
    },
    {
      "item_number": 7,
      "section": "Methods",
      "item_name": "Blinding of index test to reference standard",
      "status": "PARTIAL",
      "current_text": "Readers were blinded",
      "needed": "Specify what readers were blinded to (reference standard results, clinical information, other reader results)",
      "suggested_fix": "Expand to: 'Readers interpreted [index test] images blinded to the reference standard results, clinical information, and other readers' assessments.'",
      "fixable_by_ai": true
    }
  ]
}

Field definitions:

• compliance_pct: present / (total_items - na) * 100, rounded to one decimal
• action_items: Array of MISSING and PARTIAL items only (PRESENT and N/A excluded)
• fixable_by_ai: true if the fix involves inserting or expanding text with information available in the manuscript or inferable from context; false if it requires external information (e.g., registration number, IRB approval number, specific protocol details only the author knows)
• suggested_fix: Concrete draft text that can be inserted or used to expand an existing sentence

---

Assessment Standards

Be Strict

• PARTIAL means the item is mentioned but lacks specificity. For example:
  • "We used appropriate statistical tests" = PARTIAL (which tests?)
  • "We used the Mann-Whitney U test for continuous variables and Fisher's exact test for categorical variables" = PRESENT
• A vague reference does not count as PRESENT. The detail level must match what the guideline expects.

Be Specific in Suggestions

• For MISSING items, provide a draft sentence the user can insert.
• For PARTIAL items, point to the exact gap and suggest specific additions.
• Reference the specific manuscript section where the addition should go.

Common Gaps to Watch For

These items are frequently missing in medical manuscripts:

1. Study registration number (CONSORT, PRISMA, STARD)
2. Registration / amendment date consistency (PRISMA 2020, PRISMA-DTA, CONSORT, SPIRIT) — run Step 4c whenever a registration identifier is present
3. Sample size justification (CONSORT, STROBE, STARD)
4. Missing data handling (all guidelines)
5. Blinding details (CONSORT, STARD)
6. Funding and conflicts of interest (all guidelines)
7. Ethics approval with committee name and approval number (all guidelines)
8. Data availability statement (increasingly required)
9. AI-specific: training/validation/test split details (TRIPOD+AI, CLAIM, STARD-AI)
10. AI-specific: model architecture and hyperparameters (TRIPOD+AI, CLAIM, STARD-AI)
11. AI-specific: failure mode analysis (CLAIM, STARD-AI)
12. AI-specific: fairness/bias assessment (STARD-AI)
13. AI-specific: commercial interests and data/code availability (STARD-AI)

---

Submission Checklist Export

Many journals require a filled reporting checklist to be submitted alongside the manuscript. When the user asks for a submission-ready checklist, format the output as:

{Guideline Name} Checklist

Manuscript title: {title}
Date: {YYYY-MM-DD}

| Item # | Checklist Item | Reported on Page # | Reported in Section |
|--------|---------------|-------------------|-------------------|
| 1 | {item text} | {page or N/A} | {section} |
| 2 | {item text} | {page or N/A} | {section} |
| ... | ... | ... | ... |

Page numbers should be filled in by the user after final formatting. Use section names as placeholders.

---

Skill Interactions

When	Call	Purpose
During manuscript writing	/write-paper Phase 7	Final compliance check
Need to add Methods text	/write-paper Phase 3	Draft missing Methods content
Need statistical details	/analyze-stats	Generate missing statistical reporting
Need flow diagram	/make-figures	Generate CONSORT/STARD/PRISMA diagram

---

Error Handling

• If the manuscript file cannot be read, ask the user for the correct path.
• If the study type is ambiguous, ask the user to confirm before selecting a guideline.
• If a checklist item is genuinely unclear in its applicability, mark as N/A with justification.
• This is a pre-screening tool. Always remind the user that final compliance should be verified by all co-authors and ideally by a methodologist.

Language

• Checklist content and compliance report: English
• Communication with user: Match user's preferred language
• Medical terms: English only

Anti-Hallucination

• Never fabricate references. All citations must be verified via /search-lit with confirmed DOI or PMID. Mark unverified references as [UNVERIFIED - NEEDS MANUAL CHECK].
• Never invent clinical definitions, diagnostic criteria, or guideline recommendations. If uncertain, flag with [VERIFY] and ask the user.
• Never fabricate numerical results — compliance percentages, scores, effect sizes, or sample sizes must come from actual data or analysis output.
• If a reporting guideline item, journal policy, or clinical standard is uncertain, state the uncertainty rather than guessing.

---

Gates

Gate	Severity	Trigger	Action on fail
Mandatory items present	ENFORCED at submission	< 100% of guideline-mandatory items marked PRESENT	Auto-fix MISSING items where text exists; otherwise route to /write-paper Phase 7 for re-draft
Step 4d PRISMA Figure 1 arithmetic & cross-reference audit (PRISMA / PRISMA-DTA only)	ENFORCED for SR/MA	flow numbers don't sum (e.g., screened ≠ included + excluded), or in-text counts mismatch flow diagram	HALT; reconcile against extraction artifacts
Optional items (e.g., supplementary AI declarations)	ADVISORY	< 80% of optional items present	warn; user accepts
Cross-reporting-guideline routing (study type → guideline)	ENFORCED	study type undeclared or guideline missing	Ask user; do not silently default