THE IMPACT OF USING A PARTIALLY RANDOMIZED PATIENT PREFERENCE DESIGN WHEN EVALUATING ALTERNATIVE MANAGEMENTS FOR HEAVY MENSTRUAL BLEEDING

Objective To identify the advantages and disadvantages of using a part ially randomised patient preference design rather than a conventional randomised controlled design when evaluating alternative managements f or heavy menstrual bleeding. Design Randomised controlled comparison o f two clinical trial designs with subsequent follow up of the cohorts of women generated. Participants Women attending a general gynaecology clinic for the first time because of heavy menstrual bleeding. Interv entions Partially randomised patient preference clinical trial design and conventional randomised controlled design. Main outcome measures O verall participation; participation in randomised clinical trial of me dical management compared with transcervical surgical resection of the endometrium; prognostic characteristics (socio-demographic and Short Form 36) of clinical trial groups; outcomes (clinical and Short Form 3 6) of clinical trial groups. Results Overall, more women participated in the partially randomised patient preference design (130/135 vs 97/1 38; difference 27%, 95% CI 18% to 34%) but there was no difference in the numbers who agreed to be randomised (90/135 vs 97/138; difference -3%, 95% CI -15% to 7%). Women who chose medical management tended to have better general health, to be less restricted by their menstrual p roblems, with fewer having been previously treated by their general pr actitioner. Those who chose transcervical resection of the endometrium had all tried medical management and had higher bleeding scores. Foll ow up satisfactions and acceptability rates, and Short Form 36 scores were highest after transcervical resection of the endometrium, whether chosen or randomised. Acceptability and a desire to continue the same treatment was greater among those who chose medical management than t hose randomly allocated it. Conclusions Use of the partially randomise d patient preference design did not affect recruitment to the randomis ed controlled trial suggesting that a conventionally designed trial wo uld not be biased by motivational factors in this context. Data from t he preference groups informed the generalisability of the results but did tend to confirm conclusions that anyway reasonably followed from t he randomised controlled trial. The extra resource implications of usi ng the partially randomised patient preference design were significant reflecting the additional 40% who participated and the extra analyses entailed.