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Supplement to Gifford AL et al. Participation in Research and Access to Experimental Treatments by HIV-Infected Patients. N Engl J Med 2002;346:1373-82.

Supplementary Appendix 1. Abstraction of Data on Race or Ethnic Group and Sex from Published Medical Literature.

The proportions of patients of various races or ethnic groups and of each sex were abstracted from reports of clinical trials of human immunodeficiency virus (HIV) medications published in key journals in the indexed medical literature. On June 1, 2000, a Medline computer search was conducted for articles published between 1996 and 2000 with the key words "HIV infections" and "drug therapy" and restricted to published reports of clinical trials written in English. From the 516 references that were retrieved, we selected the 345 that appeared in one of eight general medical journals (the American Journal of Medicine, Annals of Internal Medicine, Archives of Internal Medicine, the Journal of the American Medical Association, the Journal of General Internal Medicine, the Journal of Medicine, Lancet, and the New England Journal of Medicine), and six subspecialty journals on infectious diseases (AIDS, AIDS Research and Human Retroviruses, Antimicrobial Agents and Chemotherapy, Clinical Infectious Diseases, the Journal of Acquired Immune Deficiency Syndromes, and the Journal of Infectious Diseases). These journals were selected to represent the literature on clinical trials that is routinely used by physicians in the United States to make decisions about the clinical care of patients with HIV or the acquired immunodeficiency syndrome.

Titles, text abstracts, and key words were reviewed independently by two of the authors (D.K.L. and A.L.G.) to restrict the sample further to primary reports on studies that enrolled HIV-infected adults and were conducted primarily or entirely in the United States. The full text of these articles was obtained, as was the full text of references for which Medline did not include information about study participants, the geographic location of the study, or both. From these 265 articles, the following data were abstracted: sample size, race or ethnic group of participants, and sex of participants. A total of 18 percent of the articles classified subjects as white or nonwhite and did not provide more detailed data on race or ethnic group. Subjects for whom we abstracted data from these articles made up 17 percent of the total group of subjects with abstracted data. Therefore, for the purposes of overall summary, non-Hispanic blacks, Hispanics, Native Americans, Alaskan Natives, Asians, and Pacific Islanders were classified as nonwhite and added to the totals of nonwhite participants. Finally, the overall percentages of white and nonwhite patients in the abstracted data were calculated.


 

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