8. Randomized Controlled Trials

  1. Stephen J. Walters

Published Online: 10 SEP 2009

DOI: 10.1002/9780470840481.ch8

Quality of Life Outcomes in Clinical Trials and Health-Care Evaluation: A Practical Guide to Analysis and Interpretation

Quality of Life Outcomes in Clinical Trials and Health-Care Evaluation: A Practical Guide to Analysis and Interpretation

How to Cite

Walters, S. J. (2009) Randomized Controlled Trials, in Quality of Life Outcomes in Clinical Trials and Health-Care Evaluation: A Practical Guide to Analysis and Interpretation, John Wiley & Sons, Ltd, Chichester, UK. doi: 10.1002/9780470840481.ch8

Author Information

  1. School of Health and Related Research, University of Sheffield, UK

Publication History

  1. Published Online: 10 SEP 2009
  2. Published Print: 25 SEP 2009

ISBN Information

Print ISBN: 9780470753828

Online ISBN: 9780470686140

SEARCH

Keywords:

  • randomized controlled trials (RCTs) in evaluating alternative treatments or interventions;
  • randomized double-blind and writing study protocol;
  • Consolidation of Standards for Reporting Trials (CONSORT) statement;
  • intention-to-treat and per-protocol analyses;
  • patient flow diagram;
  • CONSORT statement and reporting results of RCTs;
  • CONSORT flow chart for acupuncture study;
  • minimum clinically important difference (MCID);
  • cluster randomized controlled trials

Summary

This chapter contains sections titled:

  • Summary

  • Introduction

  • Randomized controlled trials

  • Protocols

  • Pragmatic and explanatory trials

  • Intention-to-treat and per-protocol analyses

  • Patient flow diagram

  • Comparison of entry characteristics

  • Incomplete data

  • Main analysis

  • Interpretation of changes/differences in quality of life scores

  • Superiority and equivalence trials

  • Adjusting for other variables

  • Three methods of analysis for pre-test/post-test control group designs

  • Cross-over trials

  • Factorial trials

  • Cluster randomized controlled trials

  • Further reading