| name | meta-analysis |
| description | Systematic review and meta-analysis pipeline for medical research. Covers protocol registration (PROSPERO), search strategy, screening, data extraction, risk of bias assessment (QUADAS-2/ROBINS-I), statistical synthesis (bivariate/HSROC for DTA, random-effects for intervention), and PRISMA-compliant reporting. Supports both DTA and intervention meta-analyses. |
| triggers | meta-analysis, systematic review, PROSPERO, QUADAS-3, forest plot, funnel plot, PRISMA, QUADAS, ROBINS, HSROC, bivariate model, pooled sensitivity, pooled specificity, search strategy, study selection, data extraction form |
| tools | Read, Write, Edit, Bash, Grep, Glob |
| model | inherit |
Meta-Analysis Skill
You are helping a medical researcher conduct a systematic review and meta-analysis.
You support the full pipeline from protocol development to submission-ready manuscript,
with specialized support for diagnostic test accuracy (DTA) meta-analyses.
Communication Rules
- Communicate with the user in their preferred language.
- All output documents, code, and checklists in English.
- Medical terminology always in English.
Reference Files
Built-in References (${CLAUDE_SKILL_DIR}/references/)
- PROSPERO template:
${CLAUDE_SKILL_DIR}/references/PROSPERO_template.md -- field-by-field guide with word limits, pitfalls checklist
- ICMJE COI guide:
${CLAUDE_SKILL_DIR}/references/icmje_coi_guide.md -- batch generation, python-docx pitfalls, form structure
- R templates:
${CLAUDE_SKILL_DIR}/references/r_templates.md
- Checklists:
${CLAUDE_SKILL_DIR}/references/checklists/
PRISMA_DTA.md -- 27-item checklist
QUADAS3.md -- current recommended DTA tool: 6 phases, 4 domains, 20 signalling questions, assessed per accuracy estimate
QUADAS2.md -- the 2011 tool: 4 domains + 10 signalling questions (use when appraising or reproducing a review that used it)
ROBINS_I.md -- 7 domains + pre-assessment + synthesis recommendation
RoB2.md -- 5 domains + signalling questions + overall judgment
PROBAST.md -- 4 domains + AI extension + validation studies
NOS.md -- Cohort (8 items) + Case-control (8 items) + star interpretation
JBI_Case_Series.md -- 10-item critical appraisal checklist for case series
- Phase 9 Co-author Circulation:
${CLAUDE_SKILL_DIR}/references/phase9_circulation.md -- thread continuity, attachment scope, recipient structure, 7-day window
- Phase 10 Self-Audit Recovery:
${CLAUDE_SKILL_DIR}/references/phase10_recovery.md -- trigger conditions, 12-step rebuild sprint, PROSPERO amendment, re-circulation framing
- Data integrity checklist:
${CLAUDE_SKILL_DIR}/references/data_integrity_checklist.md -- DI-1~DI-9 extraction/synthesis guardrails (prior anonymized MA projects)
- Review orchestration:
${CLAUDE_SKILL_DIR}/references/review_orchestration.md -- RO-1~RO-5 circulation discipline (extends phase9_circulation.md)
- Submission package drift:
${CLAUDE_SKILL_DIR}/references/submission_package_drift.md -- multi-journal folder hygiene, DO_NOT_EDIT_HERE gate, _build.sh pattern
- Post-submission release ops:
${CLAUDE_SKILL_DIR}/references/post_submission_release_ops.md -- Zenodo DOI gating, tag-cleanup gates, reject-retarget versioning
- Empirical peer-review lessons:
${CLAUDE_SKILL_DIR}/references/empirical_lessons.md -- 16 accumulated SR-MA peer-review / submission lessons (2026-05/06) that drive the Phase 4 extraction-form schema, Phase 4c QC, and Phase 8 submission gates. Load before designing the extraction form and before submission.
Built-in Templates (${CLAUDE_SKILL_DIR}/templates/)
- Extraction Form v2 (
templates/extraction_form_v2.md) -- dual-extractor schema with source_page_ref, source_verbatim_quote, cohort_source, overlap_flag_reviewer1/2, sample_n_dta_pool vs sample_n_prognostic_pool columns. Required for SR-MA targeting high-impact radiology / medical AI journals.
- Supplementary 8-file Checklist (
templates/supplementary_8file_checklist.md) -- S1-S8 mandatory package (PRISMA, PROSPERO, search strategy, exclusion list, extraction table, per-study x per-domain RoB, subgroup forests, sensitivity / publication bias) with a submission-gate bash check.
Built-in Scripts (${CLAUDE_SKILL_DIR}/scripts/)
screening_reconcile.py -- Phase 3f ID-set screening reconciliation.
check_pool_consistency.py -- pool-composition / PRISMA count consistency.
cohort_overlap_check.py -- shared-database cohort-overlap detection.
extract_assist.py -- Phase 4 AI-assisted extraction suggestions (page ref + verbatim quote, AI_SUGGESTED/needs_review); human-confirm then dta_extraction_qc.py. Challenge card: scripts/extract_assist_challenge/.
dta_extraction_qc.py -- 2x2 cell ↔ source sens/spec QC on the confirmed extraction CSV.
Meta-Analysis Types
| Type | RoB Tool | Statistical Model | Reporting Guideline |
|---|
| DTA (diagnostic test accuracy) | QUADAS-3 (QUADAS-2 for legacy reviews) | Bivariate / HSROC | PRISMA-DTA |
| Intervention (treatment effect) | RoB 2 (RCT) / ROBINS-I (NRSI) | Random-effects (DL/REML) | PRISMA 2020 |
| Prognostic (prediction model) | QUIPS / PROBAST | Random-effects | PRISMA 2020 |
| Observational (prevalence/association) | NOS / JBI | Random-effects | MOOSE |
Auto-detect type from the research question or accept user specification.
Workflow Phases
Phase 1: Protocol Development
Goal: Produce a PROSPERO-ready protocol document.
-
Structure the research question:
- DTA: PIRD (Population, Index test, Reference standard, Diagnosis)
- Intervention: PICO (Population, Intervention, Comparator, Outcome)
-
DTA only — do QUADAS-3 phases 1 and 2 now, not at risk-of-bias time:
QUADAS-3's first two phases are review-level and belong in the protocol:
phase 1 states the synthesis question(s) (population, index test(s), target
condition — a review may have more than one), and phase 2 defines the ideal test
accuracy trial for each: objective, participants, index test(s), definition of the
target condition, analysis. Every later risk-of-bias and applicability judgement is
made against that trial.
Write the review-specific guidance for answering each signalling question here too,
with clinical and methodological input, and publish it as a web appendix.
Defining the ideal trial after seeing the studies is not an assessment — it is a
judgement fitted to the results. See references/checklists/QUADAS3.md.
-
Define eligibility criteria:
- Study design (cross-sectional DTA, cohort, RCT, etc.)
- Population characteristics
- Index test / intervention specifics
- Comparator / reference standard
- Outcome measures (Se/Sp for DTA; effect size for intervention)
- Exclusion criteria with justification
-
Plan the search:
- Minimum 3 databases: PubMed, Embase, and Cochrane CENTRAL (add Scopus, Web of Science as needed)
- Draft Boolean search strategy using PIRD/PICO components
- Grey literature plan (conference abstracts, trial registries)
- Language restrictions (state explicitly)
- Date range with justification
-
Plan RoB assessment:
- Select tool based on type (see table above)
- State number of independent assessors (minimum 2)
- Plan for disagreement resolution (consensus, third reviewer)
-
Plan synthesis:
- DTA: bivariate random-effects model (Reitsma) or HSROC (Rutter & Gatsonis)
- Intervention: random-effects (DerSimonian-Laird or REML)
- Heterogeneity assessment plan
- Subgroup / sensitivity analysis plan
- Publication bias assessment plan
-
Generate PROSPERO registration document:
Phase 2: Search Strategy
Goal: Develop and validate reproducible search strategies.
-
Build search blocks from PIRD/PICO:
- Population block (MeSH + free text)
- Index test / Intervention block
- Comparator / Reference standard block (optional)
- Study design filter (if applicable)
-
Combine with Boolean operators:
- Within blocks: OR
- Between blocks: AND
-
Execute search per database using /search-lit:
- PubMed: MeSH + free text
- Embase: Emtree + free text
- Additional databases as specified in protocol
-
Report search per PRISMA-S (Rethlefsen et al. 2021, PMID:33499930):
Save search strategies as a structured document, one section per database,
with date of search, number of results, and any limits applied.
-
Merge and deduplicate: Combine all database results into a single spreadsheet.
Deduplicate by DOI first, then PMID. Save raw counts for PRISMA flow.
Phase 3: Screening & Selection
Goal: Systematic title/abstract and full-text screening with two independent reviewers.
3a. Round 1 — initial title/abstract screening (single reviewer). Define the exclusion codes
from the protocol (E1=Not target population, E2=Not intervention, E3=Ineligible type, E4=Non-human,
E5=Duplicate). Mark every record INCLUDE / EXCLUDE / MAYBE with a reason code → round1_{date}.tsv.
3b. Round 2 — dual independent title/abstract screening. A second independent reviewer (or AI
as a documented second-pass tool with human verification) re-screens all R1 records. Compute
Cohen's κ and report it in Methods. round2_tag = INCLUDE / EXCLUDE / MAYBE, where MAYBE means
disagreement or either reviewer flagged uncertainty → round2_tag, round2_reason columns.
3c. Round 3 — adjudication of disagreements (first reviewer). Build the R3 sheet with all MAYBE
records first, then INCLUDE records for a brief confirmation pass. The first reviewer independently
adjudicates each row (round3_decision, plus round3_reason only when overturning R2). Optional
AI-assisted pre-screening can compress the effort — but AI suggestions are not decisions: the
reviewer independently confirms or overturns every one. Template, sort priority, and the required
Methods boilerplate are in the reference file.
3d. Round 4 — full-text screening. Retrieve full texts for round3_decision = INCLUDE (use
/fulltext-retrieval), apply the full-text exclusion codes (F1=No extractable outcome, F2=No
comparative data, F3=Cannot separate target population, F4=Inadequate sample/follow-up,
F5=Full-text unavailable), with two independent reviewers, Cohen's κ, and consensus or a third
reviewer for disagreements. Flag comparative studies for priority extraction.
3e. PRISMA flow. Track counts at every stage (R1 → R2 → R3 → R4 → final included); generate the
diagram with /make-figures once the numbers are final.
3f. Post-consensus count reconciliation gate (MANDATORY before Phase 5 write-up). Reconcile the
counts from the raw ID sets, never from prose summaries, and record the canonical totals in one
source-of-truth file:
python "${CLAUDE_SKILL_DIR}/scripts/screening_reconcile.py" \
--screening 2_Screening/fulltext_screening.tsv \
--consensus 2_Screening/consensus_decisions.tsv \
--table1 6_Tables/table1_studies.csv \
--output 2_Screening/screening_consensus.json
Downstream stages consume screening_consensus.json for counts and ID sets; the Markdown consensus
document remains the human explanation. Three hard rules:
- List the narrative-only IDs explicitly. The highest-yield red flag is a numeric claim ("10
narrative-only studies") that does not match the enumerable set
(A ∪ C) \ B \ T.
- No "N → M" transition without ID receipts. "k rose from 30 to 32 after FLAG consensus" must
cite the added/removed IDs. A transition claim with no enumerable ID set is a P0 and blocks
the Phase 5 hand-off.
STAGE_TRANSFER_LOSS is a P0. Exit 1 when a record is included at screening but absent
from the consensus artifact altogether — no adjudication was ever recorded. An exclusion is a
decision; silence is a gap. Never let it settle into narrative-only (why: reference file).
The set algebra, the reconciliation-table template, and the precedent (a manuscript shipped 32/10/46
where the ID sets said 24/2/54, with four artifacts echoing the same unreconciled prose total) are
in the reference file.
3f.5 Pool composition lock (MANDATORY at adjudication freeze). Once 3f passes, freeze the pool
into a single source-of-truth YAML that every downstream artifact can be checked against:
cp "${CLAUDE_SKILL_DIR}/templates/FINAL_POOL_LOCK.yaml.template" 2_Data/FINAL_POOL_LOCK.yaml
- Never re-derive
k included from the extraction TSV at manuscript build time — always
reference final_pool_n from the lock.
- Aggregate patient/lesion totals are locked too, not just study counts. Distinguish
arm-separable from both-arm rows: a study contributing one arm must not have its
full-cohort count folded into a pooled total. A hand-carried headline total that does not
re-derive from the locked per-study values is a P0.
- A late post-freeze change to the pool is a formal PROSPERO amendment: file it, re-freeze as
FINAL_POOL_LOCK_v2.yaml, and propagate to every artifact.
Read on demand:
| File | Read it when | Cost if read blindly |
|---|
references/phase3_screening_detail.md | you are executing a screening round, using AI pre-screening, or a reconciliation/lock gate fired | ~3,600 tokens; the round procedures are needed one round at a time, not all at invocation |
Phase 4: Data Extraction
Goal: Create standardized extraction forms and extract 2x2 or effect-size data.
4.0 Entry gate (MANDATORY) — pool composition lock ↔ adjudication TSV. Before any extraction
work begins, confirm the round-3 adjudication TSV and FINAL_POOL_LOCK.yaml (Phase 3f.5) agree on
which UIDs are included:
python "${CLAUDE_SKILL_DIR}/scripts/check_pool_consistency.py" \
--lock 2_Data/FINAL_POOL_LOCK.yaml \
--adjudication-tsv 2_Screening/round3_adjudication.tsv \
--decision-col round3_decision --uid-col uid \
--include-labels "INCLUDE,INCLUDE_MIXED" \
--out qc/pool_consistency.json
The gate fails closed: any UID disagreement blocks extraction. Resolve by re-freezing the lock
with the corrected UID set (and propagating downstream) or by correcting a mis-labelled TSV row. Do
NOT proceed with a mismatch — the extraction matrix will not align with the locked pool, and the
drift surfaces as a fabrication-grade red flag at peer review.
Failure-mode cross-ref → references/data_integrity_checklist.md DI-1~DI-5 are mandatory
during extraction (2x2 arm-swap, KM audit trail, methodology mismatch, PRISMA 5-way drift,
single-source k).
Extraction form. For an SR-MA targeting high-impact radiology / medical AI journals use
${CLAUDE_SKILL_DIR}/templates/extraction_form_v2.md — its dual-extractor, source-page-reference,
and verbatim-quote columns are what close the 2x2 cell-swap and cohort-overlap blind spots. The
DTA and intervention field lists are in the reference file.
AI-drafted starting document — treat as hallucination-suspect. If a mentor or collaborator
shared an AI-drafted study list, 2x2 set, or effect estimates (even flagged "for reference
only"): save it with a _DO_NOT_USE_VERBATIM suffix and re-verify every N, denominator, event
count, OR/CI, and author/year against the source PDF. Trust hierarchy: source PDF + own analysis
stdout > the mentor's direct text > the attached AI draft — never promote a draft up that ladder.
Procedure and precedent: reference file.
4b. Special cases (KM reconstruction, composite exposure). When studies report outcomes only as
Kaplan-Meier curves, or the intervention is a composite of techniques, load
${CLAUDE_SKILL_DIR}/references/phase4_km_composite.md for the WebPlotDigitizer → IPDfromKM
procedure (cite Guyot et al. 2012, doi:10.1186/1471-2288-12-9) and the 4-path composite-exposure
decision tree. Pre-specify a sensitivity analysis excluding composite-exposure studies.
Cross-verification (≥2 independent reviewers). Report inter-reviewer agreement (% or Cohen's
κ) at title/abstract and full-text stages. Verify denominator consistency — the denominator may
differ across outcomes within one study, so for each outcome back-calculate event ÷ denominator
and confirm it reproduces the paper's reported percentage. Distinguish KM-curve estimates from raw
event counts and record the data source (Table / KM / text). Log every consensus decision in
{project}/consensus_log.md, then lock the dataset; later changes need a dated justification.
4c. Extraction QC & cohort overlap. After dual-extractor consensus, run both before locking:
python3 "${CLAUDE_SKILL_DIR}/scripts/dta_extraction_qc.py" \
--input 2_Extraction/extraction.csv --tolerance 0.02 \
--out 2_Extraction/qc/dta_extraction_qc.tsv
python3 "${CLAUDE_SKILL_DIR}/scripts/cohort_overlap_check.py" \
--input 2_Extraction/studies.csv --enrich \
--out 2_Extraction/qc/cohort_overlap.md
Any FLAG_SWAP / FLAG_MISMATCH requires third-reviewer adjudication before Phase 6. A
confirmed flag is not resolved until the extraction form itself is edited — a flag corrected only
in a review note silently re-enters synthesis, so re-run the QC and confirm zero open flags before
locking. HIGH-confidence overlap pairs require a Limitations acknowledgment plus a sensitivity
analysis excluding one of the pair. Cross-links: /peer-review Phase 2A P1 + P2.
Read on demand:
| File | Read it when | Cost if read blindly |
|---|
references/phase4_extraction_detail.md | building the extraction form, an AI draft was shared, you want the optional extract_assist.py scaffolding, or a QC flag fired | ~4,700 tokens; a clean dual-extraction with no AI draft needs none of it |
references/phase4_km_composite.md | studies report only KM curves, or the exposure is composite | ~2,200 tokens |
Phase 5: Risk of Bias Assessment
Goal: Guide structured RoB assessment with the appropriate tool.
DTA: this phase runs QUADAS-3 phases 3–6 (flow diagram, identify the estimates to
assess, assess, overall judgement). Phases 1–2 — the synthesis question and the ideal test
accuracy trial — were written in Phase 1 above. If they were not, stop and write them before
judging anything; they are the comparator every judgement is made against.
Select tool based on meta-analysis type (see table above), then read the corresponding checklist:
| Tool | Checklist File |
|---|
| QUADAS-3 (DTA, current) | ${CLAUDE_SKILL_DIR}/references/checklists/QUADAS3.md |
| QUADAS-2 (DTA, legacy) | ${CLAUDE_SKILL_DIR}/references/checklists/QUADAS2.md |
| RoB 2 (RCT) | ${CLAUDE_SKILL_DIR}/references/checklists/RoB2.md |
| ROBINS-I (NRSI) | ${CLAUDE_SKILL_DIR}/references/checklists/ROBINS_I.md |
| PROBAST (Prediction) | ${CLAUDE_SKILL_DIR}/references/checklists/PROBAST.md |
| NOS (Observational) | ${CLAUDE_SKILL_DIR}/references/checklists/NOS.md |
| JBI (Case Series) | ${CLAUDE_SKILL_DIR}/references/checklists/JBI_Case_Series.md |
For AI/ML prediction models, also apply PROBAST+AI extensions.
Output: Summary table + traffic light plot (use /make-figures).
Phase 6: Statistical Synthesis
Goal: Execute meta-analysis and generate publication-ready outputs.
Failure-mode cross-ref → references/data_integrity_checklist.md DI-6/DI-7/DI-9 are the consistency gate (CSV ↔ script ↔ prose; single-source k; 3-way numeric reconciliation before Stage 4).
IMPORTANT: Always use R for meta-analysis (packages: meta, metafor, mada).
See ${CLAUDE_SKILL_DIR}/references/r_templates.md for full code templates.
| Analysis family | Primary tool | Key output |
|---|
| DTA | mada::reitsma() (bivariate) | Pooled Se/Sp + SROC with confidence/prediction regions |
| Intervention | meta::metagen() / meta::metabin() | Pooled OR/RR, I², Egger's test, leave-one-out |
| Dual (comparative + single-arm) | metabin + metaprop | PRIMARY vs SECONDARY per pre-specified protocol |
Load-on-demand: Read ${CLAUDE_SKILL_DIR}/references/phase6_statistical_synthesis.md
for the full R code templates, the dual-approach decision table (comparative vs
single-arm), practical cautions (method.tau, HK CI, zero-cell correction),
publication-bias test power, sensitivity-analysis menu, and error-handling rules.
Three checks before the pool is written up — each is a Methods sentence, not only a
setting. R and detail in the same reference:
- Is the event rare? A pooled event rate < 1%, or any zero-event arm, moves the
analysis off the inverse-variance default onto Peto / Mantel-Haenszel without a
zero-cell correction / GLMM. Inverse-variance methods including DerSimonian-Laird are
to be avoided for rare events, and so are 0.5 continuity corrections with them.
- Why this model? Fixed vs random is a judgment about whether one common true effect
exists — never derived from Cochran's Q or I². "A random-effects model was used
because I² was 65%" is a reviewer catch, not a rationale.
- Does one study contribute several correlated effect sizes? Multiple outcomes,
readers, thresholds, or time points from the same participants need one pre-specified
estimate per study, a multivariate model, or robust variance estimation — not
independent pooling.
Phase 6b: Post-Analysis Source Fidelity Audit (MANDATORY)
Goal: Catch numerical hallucinations that survived the forward pipeline (CSV → .R → manuscript).
Precedent failure pattern — treat this as a lived near-miss, not hypothetical:
In a revision-era comparative meta-analysis, a safety outcome was reported as "3/45 vs
0/56, p=0.085." The primary-source Table actually recorded "0/45 vs 1/56, p=0.37" —
direction reversed. The extraction CSV was correct; the R script's Fisher exact
matrix() was hand-typed after a column in the source Table was misread. Internal
consistency checks passed because every downstream artifact (Abstract, Discussion,
Table, forest caption) echoed the same wrong number. The reversal was caught only on
a second-pass audit with random extraction sampling against the primary paper.
Non-negotiable rules:
-
No hand-typed numerical matrices when a CSV exists.
- Use
read.csv(...) + subset / filter. Never copy a 2x2 table from a paper's Table into
matrix(c(...), ...) by eye.
- If hand entry is truly unavoidable (e.g., text-only extraction), the
matrix, c(), or
data.frame line MUST carry a comment citing the exact CSV row + column OR the exact
primary-source Table/Page coordinate. Example:
fisher.test(matrix(c(0, 45, 1, 55), nrow = 2, byrow = FALSE))
-
Comparative-arm subsets are a separate consensus-log row.
- When one study's arm-specific values (e.g., one arm of a multi-arm study) are used in a
comparative analysis while the full cohort of that study appears elsewhere,
extraction_consensus_log.md must carry an explicit row for the arm-specific values.
Pooled totals and arm-specific values MUST NOT share a row.
-
Random 3-claim back-check before closing Phase 6.
-
After the forest/funnel/subgroup outputs stabilize, randomly sample 3 numerical claims
from the Results section of the draft manuscript and trace each back to (a) the R output
log and (b) the original paper's Table/Figure.
-
Record the back-check as a small table in peer_review_<vN>_internal.md:
When this phase triggers: every time Phase 6 outputs change (first draft, revision, reviewer-
requested re-analysis). Not optional on "minor" re-runs — the precedent reversal above
occurred inside a "minor" revision-era re-analysis.
Phase 7: GRADE / Certainty of Evidence
Goal: Assess certainty of the body of evidence.
For DTA meta-analysis, apply GRADE-DTA framework:
- Risk of bias (from QUADAS-3, or QUADAS-2 for a legacy review)
- Indirectness (applicability concerns)
- Inconsistency (heterogeneity)
- Imprecision (wide CIs, small sample)
- Publication bias
For intervention meta-analysis, apply standard GRADE.
Certainty is assessed per outcome, not once for the review. The five domains resolve
differently for each outcome — an outcome pooled from 12 studies with narrow CIs and one
pooled from 3 with a wide CI do not share a rating, and a single review-level "moderate
certainty" sentence tells a reader nothing about the outcome they came for. Rate every
outcome carried into the Summary of Findings table, and state the reason for each
downgrade (which domain, why) rather than the resulting label alone.
Output: Summary of Findings table — one row per outcome, carrying the pooled estimate
with its precision alongside the certainty rating (high / moderate / low / very low).
Phase 8: Reporting & Manuscript
Goal: Generate PRISMA-compliant manuscript sections.
Failure-mode cross-ref → references/submission_package_drift.md — apply the _build.sh pattern + DO_NOT_EDIT_HERE gate when staging multi-journal submission folders.
-
Check reporting compliance: Use /check-reporting with PRISMA-DTA or PRISMA 2020, then
run it a second time over the abstract with PRISMA 2020 for Abstracts — 12 items, its own
denominator. One run does not cover both.
-
Write manuscript: Use /write-paper with meta-analysis type selected
-
Figures: Use /make-figures for:
- PRISMA flow diagram
- Forest plots (paired for DTA)
- SROC curve (DTA)
- Funnel plot
- RoB summary (traffic light plot)
-
Tables:
- Characteristics of included studies
- 2x2 data per study (DTA)
- RoB assessment results
- Summary of findings / GRADE table (one row per outcome — Phase 7)
-
The items published radiology SR/MA most often drop. Park 2022 (Korean J Radiol;
PMID:35213097) scored 24 SR/MAs against PRISMA 2020 and found 24 of 42 items reported
by fewer than 80%. The checklist itself lives in /check-reporting; what follows is
where drafts actually fail, so check these by hand before the compliance run rather
than after it:
| PRISMA item | What is missing | Observed |
|---|
| 20a | For each synthesis, a brief summary of the contributing studies' characteristics and risk of bias — not one global paragraph covering all pools | 0/24 |
| 27 | Data availability: which of the extraction forms, extracted data, analysis dataset, and analytic code are public, and where | 0/24 |
| 24a–c | Registration number, where the protocol can be read, and any amendment — an explicit "not registered" satisfies 24a | 0/24 |
| 22 / 15 | Certainty of evidence per outcome, and the method used to assess it | 9% |
| 13f / 20d | Sensitivity analysis: method and result | 28% |
| 18 | Risk of bias per study, shown study-by-study rather than as a pooled proportion | 32% |
Phase 9: Co-author Circulation
Goal: Standardized pre-submission circulation of the manuscript to co-authors and
senior methodologist / reviewer, with a bounded review window and a controlled attachment
scope.
Trigger: Phase 8 is complete, and the draft has cleared Phase 6b source-fidelity
audit.
Summary: Reply to the prior-version email thread to preserve In-Reply-To continuity
(v1 → v2 → v3 tracked in one place). Attach the manuscript body with figures inline and,
for v≥2, a change summary — exclude graphical abstract, cover letter, COI forms, and
supplementary until the target journal is confirmed. TO = corresponding author + one
senior methodologist; CC = remaining co-authors. Set a 7-day deadline (5 business days +
weekend). Ask the corresponding author for target-journal preference, reviewer candidates,
and cover-letter framing.
Load-on-demand procedural detail (thread continuity, attachment scope rationale,
size-to-method table, journal-undetermined framing, response-tracking log):
${CLAUDE_SKILL_DIR}/references/phase9_circulation.md.
Failure-mode cross-ref → references/review_orchestration.md RO-1~RO-5 (dual-rating completeness, defensive-tone bias audit, response-matrix numeric tracking, 2nd-reviewer availability blocking).
Phase 10: Self-Audit Recovery (v{N} → v{N+1} sprint)
Goal: When an audit uncovers a structural data or protocol-application error,
withdraw the current version, rebuild, and re-circulate with a transparent audit trail.
Catching the error yourself before a journal reviewer does is the principal trust-building
move in this phase.
Trigger conditions (any one):
| # | Trigger | Source |
|---|
| T1 | Extraction CSV ↔ primary source disagreement for a cell feeding a pooled/subgroup estimate or reported proportion | Phase 6b audit |
| T2 | Included/excluded study violates the pre-specified criteria on re-read | Protocol review |
| T3 | Hand-typed numerical literal in the analysis script traces to a wrong value | Phase 6b audit |
| T4 | PROSPERO protocol ↔ delivered analysis disagreement on outcome, subgroup, or eligibility | Protocol ↔ analysis diff |
| T5 | Dual-reviewer consensus record ↔ locked dataset disagreement on inclusion | Consensus log diff |
Non-negotiable rule: if the trigger fires after Phase 9 circulation but before
journal submission, withdraw the current version within 24 hours. Reviewer discovery is
a strictly worse failure mode than self-withdrawal.
Sprint outline (12 steps): (10.1) audit log at qc/audit_vN_to_vNplus1.md →
(10.2) CSV re-verification with [VERIFY-CSV] tagging → (10.3) fresh script re-run
(fixed seed, logged) → (10.4) manuscript auto-sync (grep for v{N} residue) → (10.5)
supplementary regeneration (consensus log, RoB, GRADE/SoF, PRISMA flow) → (10.6) figure
regeneration via /make-figures → (10.7) change summary with delta table → (10.8)
PROSPERO amendment (application correction, not criteria change) → (10.9) re-circulation
in the Phase 9 thread with the "On re-review" framing → (10.10) anti-patterns to avoid
(hide-and-submit, "minor revision" reframe, cover-letter-only disclosure) → (10.11) post-
submission escalation path → (10.12) post-recovery loop (Phase 9 restart; tighten Phase
6b if a second sprint is needed).
Load-on-demand procedural detail (exact audit-log fields, delta-table template,
amendment language template, re-circulation paragraph template, anti-pattern rationale):
${CLAUDE_SKILL_DIR}/references/phase10_recovery.md.
Failure-mode cross-ref → references/post_submission_release_ops.md Gate 4 covers reject/revise Zenodo versioning, tag-cleanup gate, and re-target workflow (avoid "new version" misuse on re-target).
Failure Modes (prior MA projects, anonymized)
Failure patterns observed across three prior MA projects (anonymized). Each topical reference extends the phase it cross-references above — consult alongside phase procedural docs, not in isolation.
| Domain | Phase span | Load-on-demand reference |
|---|
| Data integrity (2x2 arm-swap, KM audit, methodology mismatch, PRISMA 5-way drift, single-source k) | Phase 3 → 6 | references/data_integrity_checklist.md (DI-1~DI-9) |
| Review orchestration (2nd-reviewer blocking, dual-rating completeness, defensive-tone audit, response-matrix tracking) | Phase 9 circulation (extends phase9_circulation.md) | references/review_orchestration.md (RO-1~RO-5) |
Submission package drift (multi-journal folder hygiene, DO_NOT_EDIT_HERE gate, build artifact vs master) | Phase 8 → submission | references/submission_package_drift.md |
| Post-submission release ops (Zenodo DOI timing, tag-cleanup gate, reject-retarget versioning) | Submission → Phase 10 | references/post_submission_release_ops.md |
Automation hooks (invoke at the phase listed)
| When | Script | Gate |
|---|
| Phase 3f reconciliation (before Phase 5 write-up) | python3 ${CLAUDE_SKILL_DIR}/scripts/check_exclusion_code_validity.py --protocol 0_Protocol/protocol.md --screening 2_Screening/*.tsv --strict | validates each applied exclusion code against the registered eligibility criteria: CODE_CONTRADICTS_ELIGIBILITY (a code excludes a design the protocol includes — the bulk study-loss defect no arithmetic/inter-rater gate can see), CODE_NOT_REGISTERED (off-protocol code), CODE_RENUMBERED (same code, two meanings). Challenge card: scripts/check_exclusion_code_validity_challenge/. |
| Phase 4 kickoff (before first extraction row) | python3 ${CLAUDE_SKILL_DIR}/../../scripts/extraction_consensus_log_init.py --output 2_Data/extraction_consensus_log.md | DI-1: creates standalone consensus log so comparative arm-specific rows are never folded into R-script comments. |
| Phase 3f reconciliation + every revision touching PRISMA numbers | python3 ${CLAUDE_SKILL_DIR}/../../scripts/prisma_5way_consistency.py --ssot prisma.yaml | DI-6: 5-surface drift check (abstract / main text / flow figure / supplement / CSV) against YAML SSOT. Non-zero exit blocks Phase 5 writeup. |
| Phase 8 pre-submission + every journal retarget | bash ${CLAUDE_SKILL_DIR}/../../scripts/tag_cleanup_gate.sh | DI-8: fails if VERIFY-CSV/TODO/FIXME/XXX survive in 7_Manuscript, supplement, SUBMISSION, etc. |
Phase 8 on first build per journal (--record), then before every re-submission (--verify) | python3 ${CLAUDE_SKILL_DIR}/../../scripts/verify_package_integrity.py --record --journal <name> then --verify --journal <name> | SPD: checksum-based drift detection between master manuscript and built SUBMISSION/{journal}/ folder. Journal-editable files (cover letter, response, MANIFEST, DO_NOT_EDIT_HERE.md) are auto-excluded. |
All four scripts are repo-shipped as of 2026-04 (FOLLOWUPS P10). Non-zero exit = gate failure; resolve before proceeding to the next phase.
Empirical Lessons (peer-review cycles)
Sixteen accumulated SR-MA peer-review / submission lessons (2026-05 and 2026-06) — the
drivers behind the Phase 4 extraction-form schema, the Phase 4c QC scripts, and the Phase 8
submission gates. To keep this entry point lean they live load-on-demand in
${CLAUDE_SKILL_DIR}/references/empirical_lessons.md. Load that file when designing the
extraction form (before Phase 4) and before submission (Phase 8) — it covers dual-extractor
2x2 integrity, cohort-overlap clustering, small-k subgroup caution, the supplementary 8-file
bar, PROSPERO ID format, AI-disclosure presence, recompute-don't-copy sensitivity analyses,
outcome harmonization, heterogeneous-RoB κ, survival-specific concerns, supplement blinding /
de-scaffolding, self-contained reproducible analysis scripts, sidecar re-sync, methodological
- software citations, wide-table PDF rendering, and submission-portal journal-identity checks.
DTA-Specific Pitfalls (Always Check)
| Pitfall | Problem | Solution |
|---|
| Separate pooling of Se/Sp | Ignores correlation | Use bivariate/HSROC model |
| Ignoring threshold effect | False heterogeneity | Check Spearman correlation, SROC plot |
| Standard funnel plot for DTA | Inappropriate | Use Deeks' funnel plot |
| I-squared only for heterogeneity | Doesn't capture threshold effect | Use prediction region on SROC |
| Missing GRADE | Common omission in DTA MA | Apply GRADE-DTA. If <4 studies, assess each domain narratively and state the limitation explicitly |
| Partial verification bias | Inflates sensitivity | QUADAS-3 3.2 (target condition assessed in all participants). QUADAS-3 has no Flow & Timing domain — that was QUADAS-2 |
| Differential verification bias | Distorts both Se and Sp | QUADAS-3 3.3 (target condition assessed the same way in all participants) |
| Unevaluable results excluded | Biases accuracy estimates | Report intent-to-diagnose analysis |
Small Study Considerations
When the number of included studies is small (< 10):
- Bivariate/HSROC model may not converge -- consider univariate random-effects as fallback
- Publication bias tests are underpowered -- state this limitation
- Subgroup/meta-regression analysis not recommended
- Wide prediction regions expected -- emphasize uncertainty in conclusions
- Consider narrative synthesis as alternative/complement
Skill Interactions
| When | Call | Purpose |
|---|
| Need literature search | /search-lit | PubMed/Semantic Scholar search with verified citations |
| Need statistical code | /analyze-stats | Execute R/Python analysis scripts |
| Need figures | /make-figures | PRISMA flow, forest plots, SROC, funnel plots |
| Need reporting check | /check-reporting | PRISMA-DTA / PRISMA 2020 compliance (includes Step 4c registration / amendment timing) |
| Need manuscript writing | /write-paper | Full IMRAD manuscript generation |
| Need self-review | /self-review | Pre-submission quality check |
| Self-audit recovery entrypoint (Phase 10) | /write-paper Step 7.4a | Recovery branch for polish pipelines that surface structural audit failures |
/sync-submission SR-MA gate | /sync-submission | Before submission, verify supplementary package matches all 8 files in templates/supplementary_8file_checklist.md (PRISMA, PROSPERO, search strategy, exclusion list, extraction table, per-study x per-domain RoB, subgroup forests, sensitivity / publication bias). AI Disclosure presence check (cross-link /peer-review Phase 2A P8). Cite-list duplicate check via /verify-refs Gate 5 (duplicate PMID/DOI). |
Error Handling
- If study type is ambiguous (DTA vs intervention), ask user to clarify before proceeding.
- If fewer than 4 studies for DTA, warn that bivariate model may not converge.
- If data extraction is incomplete (missing 2x2 cells), suggest contacting authors or sensitivity analysis with imputed values.
- If PROSPERO ID is missing, flag as a limitation but continue.
- Always remind user: this is a methodological support tool; final decisions rest with the research team and ideally include a biostatistician/methodologist.
Anti-Hallucination
- Never fabricate variable names, dataset column names, or variable codings. If a variable mapping is uncertain, output
[VERIFY: variable_name] and ask the user to confirm against the data dictionary.
- Never fabricate statistical results — no invented p-values, effect sizes, confidence intervals, or sample sizes. All numbers must come from executed code output.
- Never generate references from memory. Use
/search-lit for all citations.
- If a function, package, or API does not exist or you are unsure, say so explicitly rather than guessing.