کد مقاله کد نشریه سال انتشار مقاله انگلیسی نسخه تمام متن
5723109 1608916 2016 6 صفحه PDF دانلود رایگان
عنوان انگلیسی مقاله ISI
ReviewCritical review of sham surgery clinical trials: Confounding factors analysis
ترجمه فارسی عنوان
بررسی نقاط قوت تحقیقات بالینی جراحی شوم: تجزیه و تحلیل عوامل مخلوط
کلمات کلیدی
آزمایش بالینی / اپیدمیولوژی، اثر پلاسبو، جراحی شام، اخلاق پزشکی، آزمایشات بالینی / اخلاق، سلامت عمومی،
موضوعات مرتبط
علوم پزشکی و سلامت پزشکی و دندانپزشکی سیاست های بهداشت و سلامت عمومی
چکیده انگلیسی


- In sham surgery literature there's no assessment on confounding factors effect.
- Even if sham surgery has been used as control for over 30 years it isn't a standard.
- The validity of sham surgery is not completely supported by available literature.

ObjectiveSham surgery (placebo surgery) is an intervention that omits the step thought to be therapeutically necessary. In surgical clinical trials, sham surgery serves an analogous purpose to placebo drugs, neutralizing biases such as the placebo effect. A critical review was performed to study the statistical relevance of the clinical trials about sham surgery in the light of potential confounding factors.Materials and methodsFor the critical review 52 articles were included. The possible confounding factors have been studied using a structured interpretative research form designed by the authors. This form includes the following ten confounding factors: I), lack of homogeneity among inclusion/exclusion criteria. II), false double blind. III), lack of post-surgery double blind. IV), power of the study. V), sample characteristics. VI), lost patients to Follow-up. VII), gender distribution. VIII), age equilibrium. IX), lack of psychological patient evaluation. X), lack of psychiatric patient evaluation. In most of the studies, at least one confounding factor was present.ResultsThe analysis of the confounding factors showed that they could influence the reliability of the surgical placebo effects.ConclusionsThe validity of sham surgery should be reconsidered.

ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Annals of Medicine and Surgery - Volume 12, December 2016, Pages 21-26
نویسندگان
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