| id,domain,studied_cohort,claimed_population,evidence_excerpt,cohort_profile,claimed_population_profile,boundary_violations,required_population_disambiguation,risk_if_overgeneralized,constraints,gold_checklist | |
| PBI-001,clinical_trial,"Adults 40-65 with HFrEF, NYHA II-III, eGFR>45, no recent MI","All heart failure patients including elderly and HFpEF","Enrollment excluded HFpEF and severe CKD; age cap 65","age 40-65; HFrEF only; moderate disease; kidney function preserved","all ages; HFrEF+HFpEF; broader comorbidity","HFpEF overreach; elderly overreach; CKD severe overreach","Was HFpEF studied. Any elderly subgroup. Any CKD subgroup. Any real-world registry validation.","wrong prescribing; adverse events in frail patients; false guideline strength","Under 220 words.","cohort+claimed+violations+questions" | |
| PBI-002,clinical_trial,"Adults 18-55, BMI 20-30, no diabetes, no steroids","General adult population including obese and diabetic","Exclusions remove key real-world groups","healthy adults; non-obese; non-diabetic","includes obesity; includes diabetes; includes steroid users","obesity and diabetes overreach","Any diabetic subgroup. Any BMI>35 subgroup. Any interaction analysis.","harm in diabetics; misleading benefit claims","Under 220 words.","cohort+claimed+violations+questions" | |
| PBI-003,clinical_trial,"Adults 30-70 with RA on stable methotrexate","All autoimmune disease patients","Study only RA and background therapy fixed","RA only; MTX background; age 30-70","multiple autoimmune diseases; varied backgrounds","disease class overreach; background therapy overreach","Any trials in lupus or IBD. Any biologic background subgroup.","ineffective or harmful off-label use","Under 220 words.","cohort+claimed+violations+questions" | |
| PBI-004,press_release,"Middle-aged adults; no pediatrics","Suitable for children and teens","No pediatric enrollment","no pediatrics; adult dosing only","pediatric dosing and safety implied","pediatric overreach","Any pediatric PK study. Any juvenile safety data.","pediatric adverse events; dosing errors","Under 220 words.","cohort+claimed+violations+questions" | |
| PBI-005,regulatory,"Trial enrolled reduced EF only","Label claim implies preserved EF too","Population mismatch","HFrEF only","HFpEF implied","HFpEF boundary breach","Exact label language. Any HFpEF evidence base.","mislabeling; insurer coverage distortion","Under 220 words.","cohort+claimed+violations+questions" | |
| PBI-006,guideline,"Two RCTs in hospital setting","Recommendation for community primary care","Setting differs","inpatient; monitored; short follow-up","outpatient; mixed adherence; long horizon","setting boundary breach","Any outpatient pragmatic trial. Any adherence sensitivity.","harms when monitoring absent","Under 220 words.","cohort+claimed+violations+questions" | |
| PBI-007,clinical_trial,"Age 40-65 only","Claimed benefit for elderly 80+","Age mismatch","40-65","80+","age boundary breach","Any frailty stratification. Any real-world data in 80+.","falls; renal events; drug interactions","Under 220 words.","cohort+claimed+violations+questions" | |
| PBI-008,clinical_trial,"Single country, majority one ancestry","Claimed universal across ancestries","Demographic mismatch","single region; limited ancestry diversity","global populations; diverse ancestries","ancestry boundary breach","Any multi-region trial. Any PK differences by ancestry.","variable efficacy; safety signals missed","Under 220 words.","cohort+claimed+violations+questions" | |
| PBI-009,observational,"Specialist center cohort only","Claimed general population effect","Referral bias","specialist; high severity; selected","general population","referral bias boundary breach","Any population-based replication.","false effect size; misallocation of resources","Under 220 words.","cohort+claimed+violations+questions" | |
| PBI-010,clinical_trial,"Excluded pregnant people","Claim implies safe in pregnancy","Exclusion ignored","non-pregnant only","pregnancy included","pregnancy boundary breach","Any pregnancy registry. Any reproductive tox evidence.","fetal harm; legal risk","Under 220 words.","cohort+claimed+violations+questions" | |