Med Decis Making - Determining the impact of informed choice: separating treatment effects from the effects of choice and selection in randomized trials.

Tópicos

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Resumo

CKGROUND: The Rucker 2-stage randomized trial (RCT) design and method allows treatment, preference, and selection effects to be estimated separately in clinical trials.OBJECTIVE: To understand the effect of patient choice on patient outcomes, the authors applied the Rucker design and analysis method.DESIGN: They used data from a trial of management strategies for women with atypical cells of undetermined significance (ASCUS) detected at routine cervical screening, in which informed choice using a decision aid was compared to no choice.SETTING: Women's health clinics across Australia.PATIENTS: Women aged 18 to 70 years (n = 314) with ASCUS.INTERVENTION: Women were randomized to either an informed choice of human papillomavirus (HPV) triage testing or repeat Pap testing or to no choice with random allocation to management by either option.MEASUREMENTS: Health-related quality of life (SF36) and satisfaction were measured over the course of management and up to 1 year after triage.RESULTS: Using the Rucker analysis, patients who received their choice had higher quality of life scores than those who did not choose (SF36 MCS, 6% higher, 6.0; 95% confidence interval: -0.6 to 12.9; P = 0.07; effect size 0.61 [moderate]). In contrast, the traditional RCT analysis suggested there was little difference in quality of life between the choice and no-choice trial arms.LIMITATIONS: The Rucker method assumes that the declared preferences for treatment in the choice arm are representative of the preferences that would have been observed in the no-choice arms if choice was available.CONCLUSIONS: The Rucker method should be used to estimate treatment, preference, and selection effects in randomized trials, as it adds to our understanding of the effect of choice on patient outcomes.

Resumo Limpo

ckground rucker stage random trial rct design method allow treatment prefer select effect estim separ clinic trialsobject understand effect patient choic patient outcom author appli rucker design analysi methoddesign use data trial manag strategi women atyp cell undetermin signific ascus detect routin cervic screen inform choic use decis aid compar choiceset women health clinic across australiapati women age year n ascusintervent women random either inform choic human papillomavirus hpv triag test repeat pap test choic random alloc manag either optionmeasur healthrel qualiti life sf satisfact measur cours manag year triageresult use rucker analysi patient receiv choic higher qualiti life score choos sf mcs higher confid interv p effect size moder contrast tradit rct analysi suggest littl differ qualiti life choic nochoic trial armslimit rucker method assum declar prefer treatment choic arm repres prefer observ nochoic arm choic availableconclus rucker method use estim treatment prefer select effect random trial add understand effect choic patient outcom

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