Survey of the Age Structure of “Age‐Relevant” Articles in Four General Medical Journals

Abstract

The authors analyzed clinical research articles (1980 to 1982) in four general medical journals: New England Journal of Medicine, Annals of Internal Medicine, Journal of the American Medical Association, and British Medical Journal. Of the 1943 articles surveyed, 38.2% were judged to be clinically "relevant" to the elderly. "Relevant" articles were further analyzed to determine whether they contained enough older subjects to enable the reader to draw any inferences about the particular disease or diagnostic or treatment modality studied. Criteria for "age sufficiency" included: mean age of study group (means) greater than or equal to 60 years; if means was less than 60 years, two SD or the range included at least one patient aged 70 years; and greater than or equal to 20% of the study group was older than 60 years. Overall, slightly more than 50% of clinically relevant articles had too few older subjects by the authors' quite liberal age criteria. No statistically significant differences were found among the four journals. Of the age-relevant articles, 25.5% had a mean age of sample studied of greater than or equal to 60 years, 10.9% of greater than or equal to 65 years, 5.6% of greater than or equal to 70 years, and 2.3% of greater than or equal to 75 years. The average age of all subjects studied for three conditions commonly found among the elderly was calculated: coronary artery disease (51.7 years); hypertension (49.8 years); and cancer (52.9 years). The authors concluded that many of the original articles of these four journals did not include (for 1980 to 1982) enough older subjects in their study samples to enable readers to draw any valid inferences about the older population itself.

Participation of Older People in Preauthorization Trials of Recently Approved Medicines

“…The limited inclusion of older people in clinical trials of medicines intended for use in older adults, such as drugs for cancer, cardiovascular disease, and Parkinson's disease, has been much discussed . This limited inclusion affects the generalizability of the efficacy and safety findings, especially because most older adults have multiple comorbid conditions for which they use several drugs and have pharmacokinetic and pharmacodynamic characteristics different from those of younger individuals …”

“…T he limited inclusion of older people in clinical trials of medicines intended for use in older adults, such as drugs for cancer, cardiovascular disease, and Parkinson's disease, has been much discussed. [1][2][3][4][5][6][7][8][9][10][11][12][13][14][15][16][17][18] This limited inclusion affects the generalizability of the efficacy and safety findings, especially because most older adults have multiple comorbid conditions for which they use several drugs and have pharmacokinetic and pharmacodynamic characteristics different from those of younger individuals. 19,20 Regulatory bodies of the European Union, Japan, and the United States adopted the International Conference on Harmonisation (ICH) guideline on geriatrics (E7) in 1994 to improve the representation of older people in clinical trials.…”

Screening in Frail Older People: An Ounce of Prevention or a Pound of Trouble?

“…What do we know about the risk–benefit ratios for screening in this group? Unfortunately, not much, with few studies, either therapeutic or preventive, having included frail or very old persons in the study sample, 8 but what is often observed clinically should make us pause.…”

“…Little relevant research has taken place in frail older persons 8,16 . Although there may be no choice but to extrapolate from data on younger populations, it would be prudent to do so with some reasonable clinical skepticism.…”

Paying with Interest for a High Interest in Screening

“…14 An additional problem involves the fact that most research into the diseases affecting frail older people have not included this kind of patient in their study samples. 15,16 In other words, for our patient group, in screening as in diagnosis and treatment, the data just are not in. Furthermore, even if they were, which saintly doctors and which ideal healthcare system would have the time and the energy to perform all of the recommended tests offered?…”