Methods of randomized controlled clinical trials in health services research

E Andrew Balas, Suzanne M. Austin, Bernard G. Ewigman, Gordon D. Brown, Joyce A. Mitchell

Research output: Contribution to journalArticle

40 Citations (Scopus)

Abstract

The randomized controlled clinical trial is an increasingly used method in health Services research. Analysis of methodology is needed to accelerate practical implementation of trial results, select trials for meta-analysis, and improve trial quality in health Services research. The objectives of this study are to explore the methodology of health Services research trials, create and validate a streamlined quality evaluation tool, and identify frequent quality defects and confounding effects on quality. The authors developed a quality questionnaire that contained 20 evaluation criteria for health Services research trials. One hundred one trials from the Columbia Registry of Controlled Clinical Trials were evaluated using the new quality tool. The overall agreement between independent reviewers, Cohen’s kappa, was 0.94 (±0.01). Of a possible score of 100, the trials received an average score of 54.8 (±12.5). Five evaluation criteria indicated significant quality deficiencies (sample size, description of case selection, data on possible adverse effects, analysis of secondary effect variables, and retrospective analysis). The quality of study characteristics was significantly weaker than the quality of reporting characteristics (P < 0.001). The total average scores of Medline-indexed Journals were better than the non-Medline-indexed Journals (P < 0.001). There was a positive correlation between the overall quality and year of publication (R = 0.21, P < 0.05). The authors conclude that the new quality evaluation tool leads to replicable results and there is an urgent need to improve several study characteristics of clinical trials. In comparison to drug trials, site selection, randomization, and blinding often require different approaches in health Services research.

Original languageEnglish (US)
Pages (from-to)687-699
Number of pages13
JournalMedical Care
Volume33
Issue number7
StatePublished - Jan 1 1995
Externally publishedYes

Fingerprint

Health Services Research
Randomized Controlled Trials
Controlled Clinical Trials
Random Allocation
Sample Size
Registries
Publications
Meta-Analysis
Clinical Trials
Pharmaceutical Preparations

Keywords

  • Health Services research
  • Information Systems
  • Randomized controlled clinical trial
  • Utilization management

ASJC Scopus subject areas

  • Public Health, Environmental and Occupational Health

Cite this

Balas, E. A., Austin, S. M., Ewigman, B. G., Brown, G. D., & Mitchell, J. A. (1995). Methods of randomized controlled clinical trials in health services research. Medical Care, 33(7), 687-699.

Methods of randomized controlled clinical trials in health services research. / Balas, E Andrew; Austin, Suzanne M.; Ewigman, Bernard G.; Brown, Gordon D.; Mitchell, Joyce A.

In: Medical Care, Vol. 33, No. 7, 01.01.1995, p. 687-699.

Research output: Contribution to journalArticle

Balas, EA, Austin, SM, Ewigman, BG, Brown, GD & Mitchell, JA 1995, 'Methods of randomized controlled clinical trials in health services research', Medical Care, vol. 33, no. 7, pp. 687-699.
Balas EA, Austin SM, Ewigman BG, Brown GD, Mitchell JA. Methods of randomized controlled clinical trials in health services research. Medical Care. 1995 Jan 1;33(7):687-699.
Balas, E Andrew ; Austin, Suzanne M. ; Ewigman, Bernard G. ; Brown, Gordon D. ; Mitchell, Joyce A. / Methods of randomized controlled clinical trials in health services research. In: Medical Care. 1995 ; Vol. 33, No. 7. pp. 687-699.
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