Blinded Outcome Assessment Was Infrequently Used and Poorly Reported in Open Trials

Blinded Outcome Assessment Was Infrequently Used and Poorly Reported in Open Trials

OBJECTIVE Unblinded outcome assessment can lead to biased estimates of treatment effect in randomised trials. We reviewed published trials to assess how often blinded assessment is used, and whether its use varies according to the type of outcome or assessor. DESIGN AND SETTING A review of parallel group, individually randomised phase III trials published in four general medical journals (BMJ...

Patient-Reported Outcome and Observer-Reported Outcome Assessment in Rare Disease Trials.

Reducing bias in open-label trials where blinded outcome assessment is not feasible: strategies from two randomised trials

BACKGROUND Blinded outcome assessment is recommended in open-label trials to reduce bias, however it is not always feasible. It is therefore important to find other means of reducing bias in these scenarios. METHODS We describe two randomised trials where blinded outcome assessment was not possible, and discuss the strategies used to reduce the possibility of bias. RESULTS TRIGGER was an op...

Patient-Reported Outcome and Observer-Reported Outcome Assessment in Rare Disease Clinical Trials: An ISPOR COA Emerging Good Practices Task Force Report.

BACKGROUND Rare diseases (RDs) affect a small number of people within a population. About 5000 to 8000 distinct RDs have been identified, with an estimated 6% to 8% of people worldwide suffering from an RD. Approximately 75% of RDs affect children. Frequently, these conditions are heterogeneous; many are progressive. Regulatory incentives have increased orphan drug designations and approvals. ...

Outcome assessment with blinded versus unblinded POP-Q exams.

OBJECTIVE To determine whether blinded and unblinded Pelvic Organ Prolapse Quantification (POP-Q) examinations differ in a randomized trial. STUDY DESIGN Blinded POP-Q examinations performed at 3 months and 1 year were compared with unblinded examinations performed by the surgeon in a randomized trial of vaginal mesh for pelvic organ prolapse. RESULTS Sixty-five patients were included in th...