BACKGROUND Patients' treatment preferences are often cited as barriers to recruitment in randomized controlled trials (RCTs). We investigated how RCT recruiters reacted to patients' treatment preferences and identified key strategies to improve informed decision-making and trial recruitment. METHODS Audio-recordings of 103 RCT recruitment appointments with 96 participants in three UK multicen...

OBJECTIVES To assess how the inclusion of N-of-1 trial data into randomized controlled trial (RCT) meta-analyses impacts the magnitude and precision of yielded treatment effects, using amphetamines and methylphenidate for pediatric attention deficit hyperactivity disorder as a model. STUDY DESIGN AND SETTING We combined the N-of-1 and RCT data generated from previously conducted systematic re...

The primary goal in designing a randomized controlled clinical trial (RCT) is to minimize bias in the estimate of treatment effect. Randomized group assignment, double-blinded assessments, and control or comparison groups reduce the risk of bias. The design must also provide sufficient statistical power to detect a clinically meaningful treatment effect and maintain a nominal level of type I er...

B linding refers to the concealment of group allocation from one or more individuals involved in a clinical research study, most commonly a randomized controlled trial (RCT). Although randomization minimizes differences between treatment groups at the outset of the trial, it does nothing to prevent differential treatment of the groups later in the trial or the differential assessment of outcome...

s this treatment effective? The best study to answer this question is a randomized controlled trial (RCT). Once a RCT is found to answer the therapeutic question of interest the reader must decide whether or not the authors took all of the important steps to minimize bias. The strength of the inference that we can take from the trial is based upon how well the authors have planned, executed and...

OBJECTIVE To date only a few randomized controlled studies have compared grafting strategies in patients with multi-vessel coronary disease. This study represents a pilot RCT designed to test the feasibility of a trial comparing conventional CABG performed with a LIMA-LAD plus saphenous vein grafts (LIMA+SVG) and CABG performed with total arterial grafting (TAG). METHODS Consenting patients u...

BACKGROUND The standard care in patients with a painful osteoporotic vertebral compression fracture (VCF) is conservative therapy. Percutaneous vertebroplasty (PV), a minimally invasive technique, is a new treatment option. Recent randomized controlled trials (RCT) provide conflicting results: two sham-controlled studies showed no benefit of PV while an unmasked but controlled RCT (VERTOS II) f...

The current tendency is to provide post-approval evidence from separate, often larger and less well controlled trials. Typical examples of these are pragmatic trials (randomisation, little/no control), purely prospective observational trials (no randomisation, no control) and use of historic controls. #3 New study design: Mixed RCT (cont.) In a Mixed RCT patients would be selected and randomise...

Consider treatment when the infant is having difficulty breastfeeding. Infants with mild to moderate tongue-tie, or ankyloglossia, are likely to breastfeed successfully and usually require no treatment (strength of recommendation [SOR]: B, a prospective controlled trial and a case-control study). However, mothers of infants with any degree of tongue-tie who have difficulty with breastfeeding de...

BACKGROUND Laparoscopic Roux-en-Y gastric bypass (LRYGB) is considered the gold standard in bariatric surgery, achieving durable long-term weight loss with improvement of obesity-related comorbidities. Lately, the laparoscopic mini gastric bypass (LMGB) has gained worldwide popularity with similar results to LRYGB in terms of weight loss and comorbidity resolution. However, there is a lack of r...