Skip to main content
NCBI home page
Proceedings of the Annual Symposium on Computer Application in Medical Care logoLink to Proceedings of the Annual Symposium on Computer Application in Medical Care
. 1993:586–590.

Quality evaluation of controlled clinical information service trials.

E A Balas 1, S M Austin 1, G D Brown 1, J A Mitchell 1
PMCID: PMC2850644  PMID: 8130541

Abstract

Randomized controlled clinical trials are increasingly accepted as tools of computer technology assessment and, therefore, quality evaluation of trials has great theoretical and practical significance. The purpose of this study was to assist the design of evaluation studies and synthesis of published results by developing and validating an easy-to-use quality scoring method. The development of the new scoring system was based on the available quality evaluation methods and the analysis of 19 trial reports registered in the Columbia Registry of Controlled Clinical Information Service Trials. First critical aspects and afterwards the levels of quality were defined. In spite of the fact that all quality requirements were met by some trials, the average overall quality score was 52.6 (+/- 8.7) per cent. The minimum score was 37 and the maximum was 72 per cent. Data collection and site/sample definition were better in the good quality trials, but improvement in statistical analysis was erratic. The quality scoring method was validated by using another sample of 20 registered trials. While the number of published controlled clinical trials is increasing in medical informatics, the analysis was unable to demonstrate a significant positive correlation between the quality and year of publication.

Full text

PDF
586

Selected References

These references are in PubMed. This may not be the complete list of references from this article.

  1. Altman D. G., Doré C. J. Randomisation and baseline comparisons in clinical trials. Lancet. 1990 Jan 20;335(8682):149–153. doi: 10.1016/0140-6736(90)90014-v. [DOI] [PubMed] [Google Scholar]
  2. Chalmers T. C., Smith H., Jr, Blackburn B., Silverman B., Schroeder B., Reitman D., Ambroz A. A method for assessing the quality of a randomized control trial. Control Clin Trials. 1981 May;2(1):31–49. doi: 10.1016/0197-2456(81)90056-8. [DOI] [PubMed] [Google Scholar]
  3. Chambers C. V., Balaban D. J., Carlson B. L., Grasberger D. M. The effect of microcomputer-generated reminders on influenza vaccination rates in a university-based family practice center. J Am Board Fam Pract. 1991 Jan-Feb;4(1):19–26. [PubMed] [Google Scholar]
  4. DerSimonian R., Charette L. J., McPeek B., Mosteller F. Reporting on methods in clinical trials. N Engl J Med. 1982 Jun 3;306(22):1332–1337. doi: 10.1056/NEJM198206033062204. [DOI] [PubMed] [Google Scholar]
  5. Haynes R. B., Walker C. J. Computer-aided quality assurance. A critical appraisal. Arch Intern Med. 1987 Jul;147(7):1297–1301. [PubMed] [Google Scholar]
  6. Liberati A., Himel H. N., Chalmers T. C. A quality assessment of randomized control trials of primary treatment of breast cancer. J Clin Oncol. 1986 Jun;4(6):942–951. doi: 10.1200/JCO.1986.4.6.942. [DOI] [PubMed] [Google Scholar]
  7. Peck C. C., Sheiner L. B., Martin C. M., Combs D. T., Melmon K. L. Computer-assisted digoxin therapy. N Engl J Med. 1973 Aug 30;289(9):441–446. doi: 10.1056/NEJM197308302890902. [DOI] [PubMed] [Google Scholar]
  8. Pocock S. J., Hughes M. D., Lee R. J. Statistical problems in the reporting of clinical trials. A survey of three medical journals. N Engl J Med. 1987 Aug 13;317(7):426–432. doi: 10.1056/NEJM198708133170706. [DOI] [PubMed] [Google Scholar]
  9. Sacks H. S., Berrier J., Reitman D., Ancona-Berk V. A., Chalmers T. C. Meta-analyses of randomized controlled trials. N Engl J Med. 1987 Feb 19;316(8):450–455. doi: 10.1056/NEJM198702193160806. [DOI] [PubMed] [Google Scholar]

Articles from Proceedings of the Annual Symposium on Computer Application in Medical Care are provided here courtesy of American Medical Informatics Association

RESOURCES