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.
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
- Read the checklist file from
${CLAUDE_SKILL_DIR}/references/checklists/.
- 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:
- Title and abstract
- Introduction
- Methods (all subsections)
- Results (all subsections)
- Discussion
- Tables, figures, and their captions
- Supplemental materials (if available)
- 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 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:
- Items most journals enforce strictly (e.g., ethics approval, registration, sample size)
- Items in the Methods section (easiest to fix)
- 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:
- Study registration number (CONSORT, PRISMA, STARD)
- Registration / amendment date consistency (PRISMA 2020, PRISMA-DTA, CONSORT, SPIRIT) — run Step 4c whenever a registration identifier is present
- Sample size justification (CONSORT, STROBE, STARD)
- Missing data handling (all guidelines)
- Blinding details (CONSORT, STARD)
- Funding and conflicts of interest (all guidelines)
- Ethics approval with committee name and approval number (all guidelines)
- Data availability statement (increasingly required)
- AI-specific: training/validation/test split details (TRIPOD+AI, CLAIM, STARD-AI)
- AI-specific: model architecture and hyperparameters (TRIPOD+AI, CLAIM, STARD-AI)
- AI-specific: failure mode analysis (CLAIM, STARD-AI)
- AI-specific: fairness/bias assessment (STARD-AI)
- 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.
1---2name: check-reporting3description: Check manuscript compliance with medical research reporting guidelines. Supports 33 guidelines including STROBE, CONSORT, STARD, STARD-AI, TRIPOD, TRIPOD+AI, ARRIVE, PRISMA, PRISMA-DTA, PRISMA-P, CARE, SPIRIT, CLAIM, MI-CLEAR-LLM, SQUIRE 2.0, CLEAR, MOOSE, GRRAS, SWiM, AMSTAR 2, and risk of bias tools (QUADAS-2, QUADAS-C, RoB 2, ROBINS-I, ROBINS-E, ROBIS, ROB-ME, PROBAST, PROBAST+AI, NOS, COSMIN, RoB NMA). Generates item-by-item assessment with PRESENT/MISSING/PARTIAL status.4---5
6# Check-Reporting Skill
7
8You are helping a medical researcher verify that their manuscript complies with the appropriate
9medical research reporting guideline. You perform a systematic, item-by-item audit and produce a
10compliance report suitable for journal submission.
11
12## Communication Rules
13
14- Communicate with the user in their preferred language.
15- Checklist items and report output are in English (matching guideline originals).
16- Medical terminology is always in English.
17
18## Reference Files
19
20- **Checklists (bundled, open license)**: `${CLAUDE_SKILL_DIR}/references/checklists/`
21 - `STROBE.md` -- observational studies (CC BY)
22 - `STARD.md` -- diagnostic accuracy studies (CC BY 4.0)
23 - `STARD_AI.md` -- AI diagnostic accuracy studies (CC BY, Sounderajah et al. Nat Med 2025)
24 - `TRIPOD.md` -- prediction models, classic 2015 version (CC BY, Moons et al. Ann Intern Med 2015)
25 - `TRIPOD_AI.md` -- prediction models with AI/ML (CC BY 4.0, Collins et al. BMJ 2024)
26 - `PRISMA_2020.md` -- systematic reviews (CC BY)
27 - `ARRIVE_2.md` -- animal studies (CC0)
28 - `PRISMA_DTA.md` -- DTA systematic reviews (CC BY, McInnes et al. JAMA 2018)
29 - `QUADAS2.md` -- diagnostic accuracy risk of bias (CC BY, Whiting et al. Ann Intern Med 2011)
30 - `RoB2.md` -- RCT risk of bias (CC BY, Sterne et al. BMJ 2019)
31 - `ROBINS_I.md` -- non-randomised studies risk of bias (CC BY, Sterne et al. BMJ 2016)
32 - `PROBAST.md` -- prediction model risk of bias (CC BY, Wolff et al. Ann Intern Med 2019)
33 - `NOS.md` -- observational study quality (public domain, Ottawa Hospital)
34 - `CONSORT.md` -- randomised controlled trials
35 - `CARE.md` -- case reports
36 - `SPIRIT.md` -- study protocols
37 - `CLAIM_2024.md` -- AI/ML in clinical imaging
38 - `MI_CLEAR_LLM.md` -- LLM accuracy studies in healthcare (CC BY-NC 4.0, Park et al. KJR 2024; 2025 update)
39 - `SQUIRE_2.md` -- quality improvement in healthcare/education (CC BY, Ogrinc et al. BMJ Qual Saf 2016)
40 - `CLEAR.md` -- radiomics studies (CC BY 4.0, Kocak et al. Insights Imaging 2023)
41 - `MOOSE.md` -- meta-analysis of observational studies (Stroup et al. JAMA 2000)
42 - `GRRAS.md` -- reliability and agreement studies (Kottner et al. J Clin Epidemiol 2011)
43 - `QUADAS_C.md` -- comparative DTA risk of bias, extension to QUADAS-2 (CC BY 4.0, Yang et al. 2021)
44 - `ROBINS_E.md` -- non-randomised exposure studies risk of bias (CC BY-NC-ND 4.0, Higgins et al. Environ Int 2024)
45 - `ROBIS.md` -- risk of bias in systematic reviews (Whiting et al. J Clin Epidemiol 2016)
46 - `ROB_ME.md` -- risk of bias due to missing evidence in meta-analysis (CC BY-NC-ND 4.0, Page et al. BMJ 2023)
47 - `PROBAST_AI.md` -- prediction model risk of bias, updated for AI/ML (Moons et al. BMJ 2025)
48 - `COSMIN_RoB.md` -- reliability/measurement error risk of bias (Mokkink et al. BMC Med Res Methodol 2020)
49 - `RoB_NMA.md` -- risk of bias in network meta-analysis (Lunny et al. 2024)
50 - `AMSTAR2.md` -- quality of systematic reviews (Shea et al. BMJ 2017)
51 - `PRISMA_P.md` -- systematic review protocols (Shamseer et al. BMJ 2015)
52 - `SWiM.md` -- synthesis without meta-analysis reporting (Campbell et al. BMJ 2020)
53- If a local checklist file is not found for a requested guideline, the skill constructs checklist items from its knowledge of the guideline.
54
55---
56
57## Workflow
58
59### Step 1: Select Guideline
60
61Determine the appropriate reporting guideline. Auto-detect from the manuscript type or accept
62user specification.
63
64**Auto-detection mapping:**
65
66| Study Type | Primary Guideline | AI Extension |
67|------------|------------------|--------------|
68| Observational study | STROBE | -- |
69| Randomized controlled trial | CONSORT 2010 | CONSORT-AI |
70| Diagnostic accuracy study | STARD 2015 | STARD-AI |
71| Prediction model (development/validation) | TRIPOD | TRIPOD+AI |
72| Systematic review / meta-analysis | PRISMA 2020 | -- |
73| DTA systematic review / meta-analysis | PRISMA-DTA | -- |
74| Meta-analysis of observational studies | MOOSE | PRISMA 2020 (use both) |
75| Risk of bias (DTA studies) | QUADAS-2 | -- |
76| Risk of bias (RCTs) | RoB 2 | -- |
77| Risk of bias (non-randomised intervention studies) | ROBINS-I | -- |
78| Risk of bias (non-randomised exposure studies) | ROBINS-E | -- |
79| Risk of bias (comparative DTA studies) | QUADAS-C | QUADAS-2 (use both) |
80| Risk of bias (prediction models) | PROBAST | PROBAST+AI |
81| Risk of bias (systematic reviews) | ROBIS | AMSTAR 2 |
82| Risk of bias (missing evidence in MA) | ROB-ME | -- |
83| Risk of bias (network meta-analysis) | RoB NMA | -- |
84| Risk of bias (measurement properties) | COSMIN RoB | -- |
85| Quality assessment (observational) | NOS | -- |
86| Case report | CARE | -- |
87| Study protocol | SPIRIT | SPIRIT-AI |
88| Animal study | ARRIVE 2.0 | -- |
89| AI/ML study in clinical imaging | CLAIM 2024 | -- |
90| LLM accuracy evaluation in healthcare | MI-CLEAR-LLM | STARD-AI or CLAIM 2024 (use alongside) |
91| Reliability / agreement study | GRRAS | -- |
92| SR protocol | PRISMA-P | -- |
93| Synthesis without meta-analysis | SWiM | PRISMA 2020 (use both) |
94| Quality of systematic reviews | AMSTAR 2 | ROBIS |
95| Radiomics study | CLEAR | CLAIM 2024 (if deep learning component) |
96| Educational / QI study | SQUIRE 2.0 | -- |
97
98**Rules:**
99- If the study involves AI/ML, always apply the AI extension in addition to the base guideline.
100 - **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.
101- **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.
102- **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.
103- 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.
104- If the user requests a specific guideline, use that one regardless of auto-detection.
105
106### Step 2: Load Checklist
107
1081. Read the checklist file from `${CLAUDE_SKILL_DIR}/references/checklists/`.
1092. 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.
110
111### Step 3: Scan Manuscript
112
113Read all sections of the manuscript thoroughly:
1141. Title and abstract
1152. Introduction
1163. Methods (all subsections)
1174. Results (all subsections)
1185. Discussion
1196. Tables, figures, and their captions
1207. Supplemental materials (if available)
1218. References (for registration numbers, protocol references)
122
123Gather context from the full document before starting the item-by-item assessment.
124
125### Step 4: Assess Each Item
126
127For every checklist item, determine:
128
129| Status | Criteria |
130|--------|----------|
131| **PRESENT** | The item is fully addressed with sufficient detail. |
132| **PARTIAL** | The item is mentioned or partially addressed but lacks required detail. |
133| **MISSING** | The item is not found anywhere in the manuscript. |
134| **N/A** | The item does not apply to this particular study (justify why). |
135
136For each item, record:
137- **Status**: PRESENT / PARTIAL / MISSING / N/A
138- **Location**: Section name and paragraph or approximate position (e.g., "Methods, paragraph 3")
139- **Notes**: What was found (if PRESENT/PARTIAL) or what should be added (if MISSING)
140
141### Step 4b: Section Boundary Check
142
143In addition to checklist items, verify that:
144- **Results section** contains only factual findings: no interpretation, no "why" explanations,
145 no prior literature comparisons, no evaluative adjectives without numbers.
146- **Discussion section** does not introduce new data not presented in Results.
147- Flag any boundary violation as a separate finding in Part C Action Items with the label
148 `[BOUNDARY]`.
149
150### Step 4c: Registration / Protocol Timing Consistency Check
151
152**Applies to:** systematic reviews, meta-analyses, and intervention studies with
153prospective registration (PRISMA 2020, PRISMA-DTA, PRISMA-P, MOOSE, CONSORT, SPIRIT).
154
155**Why this step exists:** the registration identifier is a single checklist item and can
156pass Step 4 even when the manuscript is internally inconsistent about *when* the
157registration or its amendments occurred relative to the analysis. An undisclosed
158post-hoc amendment is a common rejection trigger.
159
160**Five audit items (summary):** (1) registration identifier present in Methods, Abstract,
161and cover letter; (2) initial registration date precedes — or is explicitly disclosed as
162post-dating — the extraction milestone; (3) amendment dates appear in Methods, the
163described change is visible in Methods, analysis was re-run if amendment post-dates the
164lock, and no amendment post-dates submission; (4) cross-artifact agreement between
165Methods and the registry record (PROSPERO PDF, ClinicalTrials.gov export) — silent
166discrepancy is a finding; (5) retrospective-registration disclosure paragraph when
167evidence suggests post-extraction filing.
168
169**Flagging:** any failure is logged in Part C Action Items with label
170`[REGISTRATION-TIMING]`. `fixable_by_ai: false` when reconciliation requires an external
171amendment filing; `true` only when the fix is a Methods-text insertion of a date already
172disclosed elsewhere. Part D JSON includes a `registration_timing` object
173(registry, id, initial_registration_date, amendments[], timing_consistency, findings[]).
174
175**Load-on-demand procedural detail** (exact item-by-item procedure, JSON schema,
176flagging edge cases): `${CLAUDE_SKILL_DIR}/references/step4c_registration_timing.md`.
177
178### Step 5: Generate Report
179
180Produce a structured compliance report in two parts.
181
182#### Part A: Summary
183
184```
185## Reporting Guideline Compliance Report
186
187Manuscript: {title}
188Guideline: {name and version}
189Date: {YYYY-MM-DD}
190Assessed by: Claude (automated pre-screening)
191
192### Summary
193
194| Status | Count | Percentage |
195|--------|-------|------------|
196| PRESENT | {n} | {%} |
197| PARTIAL | {n} | {%} |
198| MISSING | {n} | {%} |
199| N/A | {n} | {%} |
200| **Total** | **{n}** | **100%** |
201
202Overall compliance: {PRESENT count}/{applicable count} ({%})
203```
204
205#### Part B: Item-by-Item Checklist
206
207```
208### Detailed Checklist
209
210| # | Section | Item | Status | Location | Notes |
211|---|---------|------|--------|----------|-------|
212| 1 | Title/Abstract | {item text} | PRESENT | Title | {notes} |
213| 2 | Introduction | {item text} | MISSING | -- | {suggestion} |
214| ... | ... | ... | ... | ... | ... |
215```
216
217#### Part C: Action Items (for MISSING and PARTIAL)
218
219```
220### Action Items (Priority Order)
221
2221. **[MISSING] Item {N}: {item name}**
223 - Required: {what needs to be added}
224 - Suggested location: {section, paragraph}
225 - Example text: "{draft sentence or phrase}"
226
2272. **[PARTIAL] Item {N}: {item name}**
228 - Current: {what was found}
229 - Needed: {what additional detail is required}
230 - Suggested revision: "{draft revision}"
231```
232
233Order action items by:
2341. Items most journals enforce strictly (e.g., ethics approval, registration, sample size)
2352. Items in the Methods section (easiest to fix)
2363. Items in other sections
237
238#### Part D: Machine-Readable JSON Summary
239
240Append 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).
241
242```json
243{
244 "check_reporting_version": "1.0",
245 "manuscript_title": "...",
246 "guideline": "STARD-AI",
247 "guideline_version": "2025",
248 "date": "YYYY-MM-DD",
249 "total_items": 40,
250 "present": 32,
251 "partial": 4,
252 "missing": 3,
253 "na": 1,
254 "compliance_pct": 88.9,
255 "action_items": [
256 {
257 "item_number": 12,
258 "section": "Methods",
259 "item_name": "Sample size justification",
260 "status": "MISSING",
261 "suggested_location": "Methods, after participant description",
262 "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.'",
263 "fixable_by_ai": true
264 },
265 {
266 "item_number": 7,
267 "section": "Methods",
268 "item_name": "Blinding of index test to reference standard",
269 "status": "PARTIAL",
270 "current_text": "Readers were blinded",
271 "needed": "Specify what readers were blinded to (reference standard results, clinical information, other reader results)",
272 "suggested_fix": "Expand to: 'Readers interpreted [index test] images blinded to the reference standard results, clinical information, and other readers' assessments.'",
273 "fixable_by_ai": true
274 }
275 ]
276}
277```
278
279**Field definitions:**
280- `compliance_pct`: `present / (total_items - na) * 100`, rounded to one decimal
281- `action_items`: Array of MISSING and PARTIAL items only (PRESENT and N/A excluded)
282- `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)
283- `suggested_fix`: Concrete draft text that can be inserted or used to expand an existing sentence
284
285---
286
287## Assessment Standards
288
289### Be Strict
290
291- PARTIAL means the item is mentioned but lacks specificity. For example:
292 - "We used appropriate statistical tests" = PARTIAL (which tests?)
293 - "We used the Mann-Whitney U test for continuous variables and Fisher's exact test for categorical variables" = PRESENT
294- A vague reference does not count as PRESENT. The detail level must match what the guideline expects.
295
296### Be Specific in Suggestions
297
298- For MISSING items, provide a draft sentence the user can insert.
299- For PARTIAL items, point to the exact gap and suggest specific additions.
300- Reference the specific manuscript section where the addition should go.
301
302### Common Gaps to Watch For
303
304These items are frequently missing in medical manuscripts:
305
3061. **Study registration number** (CONSORT, PRISMA, STARD)
3072. **Registration / amendment date consistency** (PRISMA 2020, PRISMA-DTA, CONSORT, SPIRIT) — run Step 4c whenever a registration identifier is present
3083. **Sample size justification** (CONSORT, STROBE, STARD)
3094. **Missing data handling** (all guidelines)
3105. **Blinding details** (CONSORT, STARD)
3116. **Funding and conflicts of interest** (all guidelines)
3127. **Ethics approval with committee name and approval number** (all guidelines)
3138. **Data availability statement** (increasingly required)
3149. **AI-specific: training/validation/test split details** (TRIPOD+AI, CLAIM, STARD-AI)
31510. **AI-specific: model architecture and hyperparameters** (TRIPOD+AI, CLAIM, STARD-AI)
31611. **AI-specific: failure mode analysis** (CLAIM, STARD-AI)
31712. **AI-specific: fairness/bias assessment** (STARD-AI)
31813. **AI-specific: commercial interests and data/code availability** (STARD-AI)
319
320---
321
322## Submission Checklist Export
323
324Many journals require a filled reporting checklist to be submitted alongside the manuscript.
325When the user asks for a submission-ready checklist, format the output as:
326
327```
328{Guideline Name} Checklist
329
330Manuscript title: {title}
331Date: {YYYY-MM-DD}
332
333| Item # | Checklist Item | Reported on Page # | Reported in Section |
334|--------|---------------|-------------------|-------------------|
335| 1 | {item text} | {page or N/A} | {section} |
336| 2 | {item text} | {page or N/A} | {section} |
337| ... | ... | ... | ... |
338```
339
340Page numbers should be filled in by the user after final formatting. Use section names as placeholders.
341
342---
343
344## Skill Interactions
345
346| When | Call | Purpose |
347|------|------|---------|
348| During manuscript writing | `/write-paper` Phase 7 | Final compliance check |
349| Need to add Methods text | `/write-paper` Phase 3 | Draft missing Methods content |
350| Need statistical details | `/analyze-stats` | Generate missing statistical reporting |
351| Need flow diagram | `/make-figures` | Generate CONSORT/STARD/PRISMA diagram |
352
353---
354
355## Error Handling
356
357- If the manuscript file cannot be read, ask the user for the correct path.
358- If the study type is ambiguous, ask the user to confirm before selecting a guideline.
359- If a checklist item is genuinely unclear in its applicability, mark as N/A with justification.
360- 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.
361
362## Language
363
364- Checklist content and compliance report: English
365- Communication with user: Match user's preferred language
366- Medical terms: English only
367
368## Anti-Hallucination
369
370- **Never fabricate references.** All citations must be verified via `/search-lit` with confirmed DOI or PMID. Mark unverified references as `[UNVERIFIED - NEEDS MANUAL CHECK]`.
371- **Never invent clinical definitions, diagnostic criteria, or guideline recommendations.** If uncertain, flag with `[VERIFY]` and ask the user.
372- **Never fabricate numerical results** — compliance percentages, scores, effect sizes, or sample sizes must come from actual data or analysis output.
373- If a reporting guideline item, journal policy, or clinical standard is uncertain, state the uncertainty rather than guessing.