The practical and ethical defects of surgical randomised prospective trials.
نویسنده
چکیده
This paper presents a strong criticism of the current enthusiasm for clinical randomised prospective studies in surgery. In the process, the author probes the 'intellectualism' or lack thereof in present day surgical attitudes. The subjects are examined against a framework of ethics and inescapable dilemmas. Ways of correcting the more obvious weaknesses are suggested. The manuscript is, and is meant to be, provocative and is particularly aimed at the academic audience served by this journal.
منابع مشابه
Transcatheter closure, mini-invasive closure and open-heart surgical repair for treatment of perimembranous ventricular septal defects in children: a protocol for a network meta-analysis
INTRODUCTION Both transcatheter device closure and surgical repair are effective treatments with excellent midterm outcomes for perimembranous ventricular septal defects (pmVSDs) in children. The mini-invasive periventricular device occlusion technique has become prevalent in research and application, but evidence is limited for the assessment of transcatheter closure, mini-invasive closure and...
متن کاملWorld Health Organisation biomedical research guidelines and the conduct of clinical trials.
The increasing importance, recognised by WHO, of prospective randomised clinical trials has led to discussion of the needfor their careful regulation in the interests of maintaining high professional ethical standards. Ethical problems which do arisefor example where biomedical research in developing countries is sponsored from abroad-may best be handled by specially established professional sc...
متن کاملAn approach to the ethical evaluation of innovative surgical procedures.
While there is an ethical obligation to improve clinical outcomes by developing better therapies, surgical innovation has largely progressed without the strict regulations required of novel pharmaceutical products. We explore the reasons why new surgical techniques are frequently introduced without the benefit of randomised controlled trials, and present an approach to the ethical evaluation of...
متن کاملTailoring study design to each stage of surgical innovation: the ideal recommendations
The pathway of surgical innovation is complex. Inherent ethical and practical characteristics make scientific evaluation of new techniques or devices by a definitive randomized controlled trial (RCT) challenging. The IDEAL Collaboration (http://www.ideal-collaboration. net) Framework for evaluating surgical innovation describes a five stage process Idea, Development, Exploration, Assessment and...
متن کاملTRYMS: the ethical and practical considerations of a double-blind placebo controlled randomised clinical trial
A double blind randomised trial is the gold standard approach to minimise the introduction of bias from trial participants, healthcare professionals and clinical trial staff. Similarly, the use of a placebo is ideal when participant self-reported Quality of Life is one of the primary objectives. However, the combination of these trial design components can present challenging ethical and practi...
متن کاملذخیره در منابع من
با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید
عنوان ژورنال:
- Journal of medical ethics
دوره 9 2 شماره
صفحات -
تاریخ انتشار 1983