Abstract
OBJECTIVE: To examine trends in study design and other characteristics of original research published inJAMA, Lancet, and theNew England Journal of Medicine (NEJM) between 1971 and 1991.
DESIGN: A retrospective cross-sectional study of original clinical research published inJAMA, Lancet, andNEJM during 1971, 1981, and 1991.
MEASUREMENTS: Four hundred forty-four articles were independently reviewed by at least two investigators and classified according to study design and other preselected study characteristics. Changes over time were analyzed by chi-square tests for categorical variables and analysis of variance for continuous variables.
MAIN RESULTS: Clinical results doubled, from 17% of all articles in 1971 to 35% in 1991 (p<0.004), while case series decreased from 30% to 4% (p<0.0001). Of 118 clinical trials, randomized controlled trials increased from 31% to 76% (p<0.003) and nonrandomized controlled trials decreased from 42% to 8% (p<0.002). Multicenter studies increased from 10% to 39% (p<0.0001) and the prevalence of health services research increased from none in 1971 to 12% in 1991 (p<0.001). The proportion of the studies explicitly excluding women from the subject population decreased from 11% in 1971 to 3% in 1991 (p<0.03). In 1991 7% of the studies were composed entirely of men subjects, while only 0.7% of the studies were specific to men’s health. Twelve percent of the studies in 1991 were specific to women’s health. Between 1971 and 1991 there was no change in the prevalence of women first authors or studies addressing women’s or minorities’ health issues.
CONCLUSIONS: Several important changes in clinical research studies published inJAMA, Lancet, andNEJM have taken place between 1971 and 1991. Clinical trials have increased in frequency, largely replacing studies containing ten or fewer subjects. Health services research has increased in prevalence, reflecting growing interest in studies addressing the delivery of health care. Our data support the hypothesis that exclusion of women from clinical research studies is an important contributor to the paucity of data concerning women’s health.
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References
Fletcher RH, Fletcher SW. Clinical research in general medical journals. N Engl J Med. 1979;301:180–3.
Healy B. The Yentl syndrome. N Engl J Med. 1991;325:274–6.
Angell M. Caring for women’s health—what is the problem? N Engl J Med. 1993;329:271–2.
Bennett JC. Inclusion of women in clinical trials—policies for population subgroups. N Engl J Med. 1993;329:288–92.
Merkatz RB, Temple R, Sobel S, et al. Women in clinical trials of new drugs—a change in Food and Drug Administration policy. N Engl J Med. 1993;329:292–6.
Wenger NK, Speroff L, Packard B. Cardiovascular health and disease in women. N Engl J Med. 1993;329:247–53.
Fowkes FGR, Garraway WM, Sheehy CK. Practice in the United Kingdom. J Epidemiol Community Health. 1991;45:102–6.
Reich J, Black DW, Jarjous D. Architecture of research in psychiatry. 1953 to 1983. Arch Gen Psychiatry. 1987;44:311–3.
Hayden GF, Saulsbury FT. A review of theJournal of Pediatrics: the first fifty years. J Pediatr. 1982;101:5–11.
Alvarez-Dardet C, Gascon E, Mur P, Nolasco A. 10-year trends in the journal’s publications. N Engl J Med. 1985;312:1521–2.
Rosenfeld R. Clinical research in otolaryngology journals. Arch Oto-laryngol Head Neck Surg. 1991;117:164–70.
Burman K. Hanging from the masthead: reflections on authorship. Ann Intern Med. 1982;90:602–5.
Friesinger GC. Who should be an author? J Am Coll Cardiol. 1986;8:1240–2.
Fye WB. Medical authorship: traditions, trends, and tribulations. Ann Intern Med. 1990;113:317–25.
Angell M. Publish or perish: a proposal. Ann Intern Med. 1986;104:261–2.
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McDermott, M.M., Lefevre, F., Feinglass, J. et al. Changes in study design, gender issues, and other characteristics of clinical research published in three major medical journals from 1971 to 1991. J Gen Intern Med 10, 13–18 (1995). https://doi.org/10.1007/BF02599570
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DOI: https://doi.org/10.1007/BF02599570