Eleanor Murray|Ellen C Caniglia|Sonja A. Swanson|Sonia Hernández–D??az|Miguel A. Hernán
Patients and investigators prefer measures of absolute risk in subgroups for pragmatic randomized trials
Harvard University|Harvard University|Harvard University|Erasmus MC|Harvard University|Harvard–MIT Division of Health Sciences and Technology|Harvard University
pragmatic randomized trials important tools shared decisionmaking guidance exists patients preferences types causal information aimed assess preferences patients investigators toward causal effects pragmatic randomized trialswe held three focus groups patients n 23 boston b surveyed n 12 interviewed n 5 investigators experience conducting pragmatic trials c conducted systematic literature review pragmatic trials n 63patients distrustful newtomarket medications unless substantially effective existing choices preferred stratified absolute risks valued adherenceadjusted analyses expected adhere investigators wanted intentiontotreat perprotocol effects felt methods estimating perprotocol effects lacking estimating perprotocol effects many pragmatic trials used inappropriate methods adjust adherence loss followupwe made four recommendations pragmatic trials improve patient centeredness 1 focus superiority effectiveness safety rather noninferiority 2 involve patients specifying priori subgroups 3 report absolute measures risk 4 complement intentiontotreat effect estimates valid perprotocol effect estimates