Top Trial Cheats.pptVIP

Top Trial Cheats Dr Rod Stables The Cardiothoracic Centre Liverpool UK No Conflicts of Interest to Declare Presentation Outline Examples without accusation Three topic areas Establishing the denominators Lost or not evaluated at follow-up Odds ratio v Risk ratios Composite outcome measures Mixing safety and efficacy measures Identify the Denominator: Tracking Trial Subjects Need to follow the fate of ALL patients From inclusion to outcomes Warning signs ! Results expressed as simple %age Smokescreen phrases : ‘In patients with outcome data …’ ‘In evaluable (surviving) patients …’ ‘When assessed at follow-up …’ Identify the Denominator: Examples Rickards and Stables CABRI long term follow-up Widely presented (but never published) Every result presented as a % value Masked incomplete follow-up No data on 120 Dutch patients More sinister impact - reported outcome measures Not Assessed for the Outcome Measure ? Trial of drug A - exercise capacity in heart failure 100 patients randomised 1 : 1 drug v placebo Outcome measure Mean exercise duration at FUP Baseline exercise duration - equal Follow up Drug 3.2 mins Placebo 2.4 mins Clinical and statistical significance Mechanism ? Not Assessed for the Outcome Measure ? Widespread implications Incomplete QCA follow up in angiographic trials Numerical handling of extreme examples QCA - MLD of occluded vessel ? = 0 QoL - score of dead patient = 0 (?excluded) Competing outcomes ↑ mortality = ↓ repeat revascularisation Event curve analysis - No of patients at risk SoS Trial: Repeat Revasc Event Curve BASIL Trial : Amputation - free Survival Solutions ? Clear exposition of patient flows Trial Profile and Patient Flow Diagram Solutions ? Clear exposition of patient flows All event rates expressed: n / d (p%) (CIs) Describe status of patients not assessed for outcome measures Express rates with correct denominators eg Repeat revasc rate per 100 patient years of Fup Full des