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January 25, 1993

Reporting of Age Data in Clinical Trials of Arthritis: Deficiencies and Solutions

Author Affiliations

From the Geriatric Research Education and Clinical Center, Brockton West Roxbury Veterans Affairs Medical Center, Division on Aging (Drs Rochon and Minaker), Robert Breck Brigham Multipurpose Arthritis Center, Brigham and Women's Hospital (Dr Fortin), Harvard Medical School, Department of Biostatistics (Dr Dear), and Technology Assessment Group (Dr Chalmers), Harvard School of Public Health, Boston, Mass. Drs Fortin and Dear are now with the Montreal (Canada) General Hospital, McGill University, and the University of Newcastle (Australia), respectively.

Arch Intern Med. 1993;153(2):243-248. doi:10.1001/archinte.1993.00410020091008

Objective:  We studied recent nonsteroidal anti-inflammatory drug (NSAID) randomized control trials of arthritis to identify the age and number of older people (≥65 years) and to document the way information on age was presented. We hypothesized that older people, who are most likely to take NSAIDs are underrepresented and underreported.

Study Selection and Data Extraction:  All NSAID articles (n=1008) in MEDLINE between September 1987 and May 1990 were identified. Eighty-three trials employing NSAIDs in a randomized control trial of arthritis reported in 73 articles were identified and studied in detail for age-related information.

Results:  A total of 9664 subjects with a female-to-male ratio of 2.3:1 were enrolled. Forty-four trials studied osteoarthritis (53.0%), 37 studied rheumatoid arthritis (44.6%), and two studied both conditions (2.4%). More than half of the studies reviewed included people 65 years of age or older, only 207 people in this older age group could be identified (2.1%). While there was inclusion of the 'young-old' (65 to 74 years of age), only 14 of the 9664 people studied were between 75 and 84 years of age, and no one 85 years or older could be identified. The inclusion of the young-old is documented by the weighted mean age that ranged from 59.6 to 64.9 years for patients with osteoarthritis (mean, 62.9; SD, 1.67) and from 47.4 to 53.0 years (mean, 49.9; SD, 2.16) for those with rheumatoid arthritis.

Conclusion:  We demonstrate that older people, who represent a high proportion of the population treated with NSAIDs in practice, are generally omitted from drug trials. Recommendations designed to improve the reporting of age information to make clinical trials more informative and applicable to older people are presented.(Arch Intern Med. 1993;153:243-248)