Physicians often have trouble motivating patients to continue participating in long-term, follow-up studies. Unfortunately, this results in reduced insight into evolving outcomes of interventions, late side effects and rare events. Iris M. Markusse, MD, a rheumatologist at the Leiden University Medical Center in The Netherlands, and colleagues questioned patients to determine what factors were associated with long-term participation in a clinical trial. Their results were published in the June 2015 issue of Arthritis Care & Research.
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“We set out to investigate the motives of patients who completed the BeSt trial [Dutch acronym for Treatment Strategies for Rheumatoid Arthritis], a 10-year, follow-up study evaluating four dynamic treatment strategies in patients with early rheumatoid arthritis (RA). In this study, visits every three months and a treat-to-target strategy based on a dynamic treatment protocol with established antirheumatic medication were continued during the total follow-up period. At every visit, a physical examination was performed by a study nurse, as were laboratory tests, and multiple questionnaires were completed,” wrote the authors in their introduction.
The BeSt study included a high frequency of visits, many questionnaires and additional examinations, such as dual-energy X-ray absorptiometry and radiographs of hands and feet. After 10 years, 60% of the 508 enrolled patients were still under follow-up. First, investigators sought to determine which patients were most likely to drop out of the study. They found that these patients tended to be older and had worse functional disability, drug-free remission, little joint damage and/or more adverse events. In particular, patients with worse functional ability were likely to leave the study regardless of age. Not surprisingly, the arm that the patient was randomized into also played a role in the decision to drop from the study.
On the final visit of the 10-year study, patients were given a questionnaire to determine their motives for continued participation. The questionnaire included 19 statements that described possible reasons a patient would continue to participate in a clinical study. Patients were asked to select one or more reasons they continued to participate. Patients who continued in the BeSt study were motivated to contribute to research and help future patients. They were also more likely to continue if they were frequently monitored and had good experiences with the study protocol. These good experiences were most often the result of the study’s nurses, who were attentive, communicative and acknowledged the patient’s time investment.
Patients who believed they were gaining an understanding of their disease and learning new treatment strategies also tended to stay enrolled in the study. This finding suggested that the newsletters and meetings for BeSt patients were beneficial. Indeed, most patients found the newsletters informative and interesting. Moreover, most patients attended one or more meetings, and many found the meetings to be informative, well organized and/or interesting.