Diseases of the Colon & Rectum

, Volume 36, Issue 1, pp 43–48 | Cite as

Clinical studies in surgical journals—have we improved?

  • Michael J. Solomon
  • Robin S. McLeod
Original Contributions


A critical appraisal of all clinical studies published in 1980 and 1990 in three surgical journalsDiseases of the Colon and Rectum(DCR),Surgery(SURG), and theBritish Journal of Surgery(BJS)—was made to ascertain the frequency with which various research designs appeared, the standard of individual clinical studies, and a comparison of changes in the past decade. Clinical studies were classified into case studies or comparative studies. Comparative studies included randomized controlled trials (RCT), nonrandomized controlled trials, retrospective cohorts, and case-control studies. A 10-point index score (range, 0–10) was used to assess the comparative studies. A sample of articles was analyzed for interobserver and intraobserver variation, with strong agreement between reviewers for classification of trials (unweighted kappa, 0.87) and index scores (0.67). Of 1,481 articles reviewed, 1,060 were classified as clinical studies. Sixteen percent of all clinical studies were comparative studies in 1980, compared with 17 percent in 1990. Of these, 7 percent were RCT in both years. In 1980, 6 percent of clinical studies in DCR were comparative studies, 19 percent in BJS, and 18 percent in SURG. In 1990, 11 percent, 18 percent, and 18 percent, respectively, were comparative studies. In 1980, the proportion of RCT in DCR was 0 percent, in BJS 12 percent, and in SURG 4 percent, compared with 3 percent, 8 percent, and 8 percent, respectively, in 1990. Overall, 52 of 76 (68 percent) RCT were published in BJS. The standard of comparative studies increased overall from 5.49 to 6.04 (P=NS), and that of RCT increased from 7.06 to 7.70 (P=NS). The standard of comparative studies in DCR in 1980 was lower than those in BJS (P<0.001) and SURG (P<0.001). The standard of comparative studies in DCR improved from 1.67 in 1980 to 5.47 in 1990 (P<0.001). There was no significant difference in the standard of comparative studies among the three journals in 1990. In conclusion, there has been no overall increase in the proportion of stronger clinical trial designs in the journals reviewed. A small increase seen in the overall standard of comparative studies was not statistically significant.

Key words

Epidemiology Clinical trials Research design Surgery 


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  1. 1.
    Fletcher RH, Fletcher SW. Clinical research in general medical journals: a 30-year perspective. N Engl J Med 1979;301:180–3.PubMedGoogle Scholar
  2. 2.
    Feinstein AR. Clinical biostatistics. XLIV. A survey of the research architecture used for publications in general medical journals. Clin Pharmacol Ther 1978;24:117–25.PubMedGoogle Scholar
  3. 3.
    Kramer MS, Boivin J-F. Toward an “unconfounded” classification of epidemiologic research design. J Chronic Dis 1987;40:683–8.CrossRefPubMedGoogle Scholar
  4. 4.
    Evans M, Pollock AV. A score system for evaluating random control clinical trials of prophylaxis of abdominal surgical wound infections. Br J Surg 1985;72:256–60.PubMedGoogle Scholar
  5. 5.
    Fleiss JH. Statistical methods for rates and proportions. New York: John Wiley & Sons, 1973:146.Google Scholar
  6. 6.
    Barnes RW. Understanding investigative clinical trials. J Vasc Surg 1989;9:609–18.PubMedGoogle Scholar
  7. 7.
    Haines SJ. Randomized clinical trials in the evaluation of surgical innovation. J Neurosurg 1979:51:5–11.PubMedGoogle Scholar
  8. 8.
    Sackett DL, Haynes RB, Tugwell P. Clinical epidemiology. A basic science for clinical medicine. Boston: Little, Brown and Co., 1985.Google Scholar

Copyright information

© American Society of Colon and Rectal Surgeons 1993

Authors and Affiliations

  • Michael J. Solomon
    • 1
    • 2
  • Robin S. McLeod
    • 1
    • 2
  1. 1.Department of SurgeryUniversity of TorontoCanada
  2. 2.Mount Sinai HospitalSamuel Lunenfeld Research InstituteTorontoCanada

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