The pragmatic randomised controlled trial

In recent years there has been much debate regarding the evaluation of treatments in medicine. The evidence-based medicine (EBM) movement has formed partly out of the realisation that clinical practice is often poorly informed by the best available evidence, and that many widely used treatments are either completely untested, or tested and proven to be ineffective or even harmful. EBM has been characterised as a stick by which policy-makers and academics beat clinicians (Williams & Garner, 2002). However, another side to EBM has been the realisation that research performed to test new treatments has often been of poor quality, or has asked the wrong questions (Hotopf et al , 1997; Thornley & Adams, 1998; Barbui & Hotopf, 2001). We have previously argued that clinicians could justifiably criticise the research establishment for failing to provide answers to relevant clinical problems of everyday practice (Hotopf et al , 1999).