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There must be many surgical interventions that have not required RCTs for acceptance. Examples are total hip and knee replacements (total ankle replacement has not been accepted, following case series that showed many long-term failures). There also must be many things in emergency medicine, such as setting fractures, cleaning and sewing up wounds, etc. that have not required RCTs. And was there ever an RCT for ether? What about maintaining sterile conditions for surgery? In fact such convincing non-RCT findings have been so common in these fields that they have been slow to recognize the need for RCTs for anything. However, surgeons are more likely to get involved in RCTs in areas where surgery competes with medical management (e.g., cardiology), probably because medicines have long been required to have RCTs by national regulators. On the other hand, some surgical-medical fields (e.g., oncology) have had an aversion to RCTs even for their medical treatments (e.g., high-dose chemotherapy for breast cancer). The prominence of spectacular successes without RCTs is a major reason for the lack of needed RCTs. Proponents of new methods tend to optimistically assume their innovation is like the spectacular successes of the past, and so needs no further proof than their own published case series cobbled together retrospectively from their own patients. Sadly, proof that is adequate for a 100% success rate with no alternative, is completely inadequate to convincingly demonstrate a 10 or 20% improvement over the current standard of care. David L. Doggett, Ph.D. Senior Medical Research Analyst Health Technology Assessment and Information Service ECRI, a non-profit health services research organization 5200 Butler Pike Plymouth Meeting, PA, USA 19462 Phone: (610) 825-6000 x5509, FAX (610) 825-6834 e-mail [log in to unmask] -----Original Message----- From: Paul Glasziou [mailto:[log in to unmask]] Sent: Monday, November 03, 2003 11:07 AM To: [log in to unmask] Subject: Interventions not needing randomised trials? Dear All, Do you know of any treatments where the effect is so clear that randomised trials are clearly unnecessary? Penicillin for pneumococcal pneumonia is often quoted. But there must be others, such as CPR or surgical treatments, e.g, pressure for bleeding. Could I ask you to: 1. suggest treatments 2. suggest WHY they are so convincing that a trial is unnecessary, I will compile the suggestions and post the list in a few weeks, Many thanks Paul Glasziou Department of Primary Health Care & Director, Centre for Evidence-Based Practice, Oxford ph: 44-1865-227055 www.cebm.net