MED01 — Evidence Extraction
One block per study. Fields follow PROTOCOL-MEDICAL §M4. Never leave a field blank: write not reported in published text (only if full text + supplements were inspected), not accessible to verifier, or n/a. Filled by Claude during verification from the source itself, not from a researcher’s description of it.
S-___ — [short citation]
- Source ID: S-___ (shared SOURCE_LIBRARY · track: medical)
- Citation: authors · title · venue · year · DOI / PMID / PMCID / trial registration
- Access level: full text (+ supplements? y/n) | abstract-only | secondary report
- Publication-integrity status (§M1): none found | corrected (read) | expression of concern | retracted/withdrawn → Excluded · date checked
- Trial registration: ID · registered primary outcome matches reported? yes / no / registry not accessible
- Source type (§M3 Axis 1): primary | sr-ma | narrative-review | guideline | official
- Study design (§M3 Axis 2): rct | interventional-nr | observational | case | animal | in-vitro | mechanistic · secondary source → “rests on:” designs with counts
- Population: (age, sex, comorbidities, prior cannabis exposure, concomitant medication, inclusion/exclusion)
- Diagnosis / indication:
- Sample size: randomized / analyzed
- Intervention / formulation: whole plant | purified cannabinoid | standardized extract | pharmaceutical formulation (name)
- Cannabinoid composition: THC · CBD · other · THC:CBD ratio
- Dose:
- Route:
- Frequency:
- Duration:
- Comparator: placebo | active | usual care | baseline | observational comparator | none · blinding integrity
- Primary outcome: (instrument, timepoint, pre-registered? y/n)
- Secondary outcomes:
- Outcome type(s): symptom relief | functional improvement | disease modification | patient preference
- Harms (§M4 — every domain answered): AEs · SAEs · withdrawals · drug–drug interactions/metabolism · organ-specific signals · psychiatric/dependence · special populations (pediatric, pregnancy/lactation, older adults, on comedication)
- Effect size / statistical result: DESIGN-APPROPRIATE COMPARATIVE ESTIMATE (parallel → between-group contrast; crossover → within-participant contrast between conditions, note period/carryover/washout; cluster → clustering handled?) with interval and test — within-condition change only if labeled as such; single-arm → “uncontrolled” (§M4, D12)
- Clinical significance: (vs. stated MCID where one exists)
- Funding / conflicts:
- Limitations:
- Risk-of-bias instrument (§M4a): RoB 2 — parallel | crossover | cluster variant (rct) | ROBINS-I (interventional-nr) | AMSTAR 2 (sr-ma) | current JBI tool for the design (observational — name + version/date, item answers, no score) | none — design-appropriate free text | not applicable — abstract-only · instrument version · overall judgment + domain notes
- Appraisal provenance: own appraisal | inherited from review S-___ — same result/outcome? yes / comparable (explain) / no → re-appraised or mismatch disclosed
- Risk-of-bias notes (always):
- Applicability limits: what this study cannot be used to say
- Regulatory context: (jurisdiction + as-of date, if relevant)
- Registry cross-check (named products / keystones, §M4): registered · completed · with results — unreported trials listed
- Supports claims: MED01-C___