Literature DB >> 27582813

Evidence-based medicine in obstetrics: can levels B and C recommendations be elevated to level A recommendations?

Suneet P Chauhan1, Eugene Chang2, Brian Brost3, Barbara Assel1, Jason Baxter4, James A Smith5, Robert Grobman6, Vincenzo Berghella4, James A Scardo7, Everett F Magann8, John C Morrison9.   

Abstract

In this study, 65% (132/195) of level B/C obstetric recommendations are amenable to randomized clinical trials (RCTs) and seven were identified as most needed. The purpose of the survey was to evaluate levels B and C recommendations in obstetric practice bulletins (PBs) regarding the feasibility of performing RCT to elevate each subject to level A evidence. Eleven geographically dispersed physicians with experience in research reviewed levels B and C recommendations for the ethical and logistical feasibility of performing an RCT. In the 35 obstetric PBs, 195 level B/C recommendations were reviewed. The majority considered 47 (24%) topics unethical for an RCT and thought 16 (11%) did not need an RCT, thus leaving 132 (67%) levels B and C recommendations available for an RCT. Two-thirds of levels B and C recommendations in obstetric PB are amenable to RCTs and potentially becoming level A evidence.

Entities:  

Keywords:  ACOG obstetric bulletins; randomized clinical trials

Year:  2009        PMID： 27582813      PMCID： PMC4989722          DOI： 10.1258/om.2009.080031

Source DB:  PubMed          Journal:  Obstet Med        ISSN： 1753-495X


  10 in total

Review 1.  The revised CONSORT statement for reporting randomized trials: explanation and elaboration.

Authors:  D G Altman; K F Schulz; D Moher; M Egger; F Davidoff; D Elbourne; P C Gøtzsche; T Lang
Journal:  Ann Intern Med       Date:  2001-04-17       Impact factor: 25.391

2.  The importance of preservation of the ethical principle of equipoise in the design of clinical trials: relative impact of the methodological quality domains on the treatment effect in randomized controlled trials.

Authors:  Benjamin Djulbegovic; Alan Cantor; Mike Clarke
Journal:  Account Res       Date:  2003 Oct-Dec       Impact factor: 2.622

3.  A comprehensive ethical framework for responsibly designing and conducting pharmacologic research that involves pregnant women.

Authors:  Laurence B McCullough; John H Coverdale; Frank A Chervenak
Journal:  Am J Obstet Gynecol       Date:  2005-09       Impact factor: 8.661

4.  Science and ethics of sham surgery: a survey of Parkinson disease clinical researchers.

Authors:  Scott Y H Kim; Samuel Frank; Robert Holloway; Carol Zimmerman; Renee Wilson; Karl Kieburtz
Journal:  Arch Neurol       Date:  2005-09

Review 5.  Should desperate volunteers be included in randomised controlled trials?

Authors:  P Allmark; S Mason
Journal:  J Med Ethics       Date:  2006-09       Impact factor: 2.903

Review 6.  American College of Obstetricians and Gynecologists practice bulletins: an overview.

Authors:  Suneet P Chauhan; Vincenzo Berghella; Maureen Sanderson; Everett F Magann; John C Morrison
Journal:  Am J Obstet Gynecol       Date:  2006-06       Impact factor: 8.661

7.  Randomised placebo-controlled trials and HIV-infected pregnant women in developing countries. Ethical imperialism or unethical exploitation?

Authors:  P de Zulueta
Journal:  Bioethics       Date:  2001-08       Impact factor: 1.898

8.  Patient-centred equipoise and the ethics of randomised controlled trials.

Authors:  L G Olson
Journal:  Monash Bioeth Rev       Date:  2002-04

9.  Of consents and CONSORTs: reporting ethics, law, and human rights in RCTs involving monitored overdose of healthy volunteers pre and post the "CONSORT" guidelines.

Authors:  Thomas A Faunce; Nicholas A Buckley
Journal:  J Toxicol Clin Toxicol       Date:  2003

10.  Is it always unethical to use a placebo in a clinical trial?

Authors:  Andreas Stang; Hans-Werner Hense; Karl-Heinz Jöckel; Erick H Turner; Martin R Tramèr
Journal:  PLoS Med       Date:  2005-03-29       Impact factor: 11.069
  10 in total

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