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Rockville, MD
Correspondence to: Elizabeth Koller, MD, 5600 Fishers Lane, Parklawn Building, Room 14B04, Rockville, MD 20857
To the Editor:
Although there are some limitations in the study design, the article by Simmons et al1 (August 2000) is very provocative, and the results strongly suggest that noncompliance can be an issue even within a monitored clinical trial. The authors attempted to identify demographic features that would distinguish the medication "dumpers" from medication "nondumpers." The dumpers, though, did not appear differ significantly from the nondumpers in characteristics such as age, gender, race, body habitus type, education level, smoking history, features of asthmatic disease, or study visit follow-up rate. Areas the authors did not explore, however, were the relationship between the investigators and the patients, and what the patients’ expectations of the study were.
Only two sites and two investigators participated, suggesting that effects intrinsic to the research center and the investigators were not a factor. It is not known, however, whether the patients were being treated by the investigator outside of the trial and whether the patients and investigators had a long-standing clinical relationship. Did dumpers and nondumpers differ by these variables? It may be useful to identify patient incentives for entering the study. It is not known whether dumpers more likely to have inadequate insurance and needed the trial to obtain medical care. Nor is it known whether dumpers more likely to have participated in other clinical trials. Furthermore, it is also not known whether patients felt free to reveal problems with compliance and the features of the drug product that contributed to problems with compliance. Ultimately, this type of information is critical to improve our understanding of compliance in clinical trials.2 3 4 It could lead to more accurate drug labeling and stimulate the development of pharmaceutical products that are truly effective and functional.
References
UCLA School of Medicine Los Angeles, CA
Correspondence to: Michael S. Simmons, UCLA, Division of Pulmonary and Critical Care, Los Angeles, CA 90095-1690; e-mail: msimm{at}ucla.edu
To the Editor:
The correspondents raise some interesting questions regarding our report1 (August 2000) on compliance in the Lung Health Study, as well as the importance of future investigations in this field. The 10-center Lung Health Study was not initially designed for the purpose of investigating compliance issues, as they correctly point out. While the ancillary study on which our article is based was designed to study compliance at the two centers at which electronic medication monitors were used, some constraints and limitations were necessarily posed by the design and organization of the parent study. The patients’ motivation for entering our study cannot be determined with certainty, but no medical treatment was promised or provided except for the interventions specified in the study protocol. Possible incentives included the smoking cessation program (one half of all participants) and bronchodilator inhalers (one third of all participants received active bronchodilator inhalers). Because most participants did not have any serious or disabling symptoms (asthmatics were excluded) and no medical treatment was promised, we believe that the bronchodilator inhaler was not a motivating factor for most subjects to enter the study. We feel the promise of pulmonary function testing and the possibility of assistance with smoking cessation were the primary motivations for patient participation. The nature of the relationship between study participants and the investigators was not described in our article but, in fact, patients of study investigators were excluded from the study to avoid conflict of interest. There are no data on the patients’ medical insurance coverage or their previous participation in other clinical trials, although concurrent participation in non-Lung Health Study clinical trials was not permitted.
Study participants were asked about their bronchodilator inhaler use at each clinic visit. When poor compliance was revealed, they were queried about possible causes, including difficulties in scheduling or remembering their inhaler use, as well as any problems they may have had with the medication itself. Because the intent was to improve compliance with the study medication, free discussion was encouraged and we believe participants were comfortable discussing the use of their inhalers with clinic personnel. A notable exception, of course, would be the "dumpers" who denied problems with compliance. The motivation behind dumping in this interesting subset of noncompliant patients could in fact be related to discomfort with discussing compliance issues with study personnel. We can only speculate, however, on what the motivation for dumping may be. Because clinical trials are generally not designed to study questions of this type, future studies that focus on the motivations for compliance and deceptive practices among participants in clinical trials are needed.
References
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