Reflections on randomised controlled trials in surgery

Quality improvement report Improving design and conduct of randomised trials by embedding them in qualitative research: ProtecT (prostate testing for cancer and treatment) study Commentary: presenting unbiased information to patients can be difficult

“…Methodological literature is almost exclusively statistical and epidemiological, and very little of it is concerned with conduct or the particular demands that trials put on trialists and participants. Problems with mounting surgical trials are well known,5 and systematic reviews have identified a range of barriers for clinicians and patients. 2 6 Nested studies within ongoing trials could help to elucidate recruitment difficulties 6…”

Qualitative research in evidence-based medicine: Improving decision-making and participation in randomized controlled trials of cancer treatments

“…[49][50][51][52] In response, they developed a feasibility study to explore and resolve recruitment difficulties. 24 …”

Unique Methodological Issues Facing Randomized Controlled Trials of Endourologic Procedures

“…These questions demand a different and more "pragmatic" design. 13,35 Here, efforts are made to include endourologists with different levels of experience, expertise, and technical ability, practicing in different environments on less homogenous patients than in efficacy trials, in an attempt to more closely mirror general clinical practice.…”

“…These barriers to the performance of RCTs of surgical procedures have meant that many have never been experimentally tested (for example, radical prostatectomy v external-beam radiotherapy for early-stage carcinoma of the prostate 13 ) or have been tested only in small or poorly designed trials (as is the case for laparoscopic cholecystectomy, despite being one of the most commonly performed surgical procedures 14,15 ). In addition, the implementation of new surgical procedures is regulated differently than new medications, with no formal governmental oversight mandating evaluation of new techniques with RCTs.…”