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T-12: Asthma and COPD Patients Consider Training Necessary in Clinical Trials, Preferring Interactive Electronic Training
Clinical Science Advisor
ERT United States
Patient-reported outcomes (PROs) are often primary endpoints in respiratory disease clinical trials. Accordingly, regulatory agencies recommend patient training to improve data quality. This study examined patients’ opinion on the necessity of training and their preferred methods for training.
Participants completed an online survey assessing their opinion on 1) the necessity of training during clinical trials, 2) preferred training format, 3) accessibility of materials for the duration of the trial, and 4) how they would handle questions that may arise when completing a questionnaire.
A total of 437 participants responded to our survey. 67 participants reported being diagnosed with at least one respiratory disease (i.e., asthma and chronic obstructive pulmonary disease, COPD). Asthma and COPD participants were diverse in age (M=47.5, SD=16.2, range=18 to 88 years), education (58.8% with some college, Associates or technical degree), and household income (43.5% with income between $20,000 to $49,999). 84.1% of the participants were female.
95.4% of asthma and COPD participants considered educational materials and patient training necessities in clinical trials, with 74.2% of participants reporting that they were “definitely needed” and 21.2% stating that they were “somewhat needed”. With respect to the mode of the training, 65.7% of participants indicated that they preferred to complete interactive training on the internet or mobile electronic devices. 32.8% of participants, on the other hand, preferred having paper guides to take home. 86.6% of participants also believed that having access to the training material, in order to refresh on the information, for the duration of the trial to be “definitely needed” or “somewhat needed” (56.7% and 29.9%, respectively). When participants were asked what they would do should they have questions about how to complete a particular study question, 44.8% stated they would ask the trial doctor, while an equal number of participants (44.8%) reported they would look up information online or in reference materials. 10.4% indicated they would read the question a couple of times and try to pick the best answer.
In clinical trials assessing the treatment efficacy of respiratory diseases such as asthma and COPD, PROs are often the primary endpoints. These endpoints, including symptoms, exacerbations (use of corticosteroids, or rescue medications, and emergency room visits), impact on daily activities, and ambulatory peak expiratory flow measurements, are often recorded in daily diaries. Inter- and intra-rater variability in completing these PRO measures can reduce power to detect treatment efficacy. Hence, the Food and Drug Administration (FDA, 2009) and European Medicines Agency (2015) recommended that patients be trained on respiratory function testing and completion of diaries. However, patients’ opinion regarding the necessity of the training and their preference for the method of training has rarely been explored.
Findings from our study showed that the vast majority of participants viewed educational materials and training as an integral part of clinical trial participation. Moreover, most of the respondent indicated that they preferred electronic modes of training and having the ability to review training materials as needed for the duration of the trial. These results suggest that patients’ opinion on the necessity of training in clinical trials are in line with recommendations in regulatory PRO guidance. Findings of that less than half of participants would ask site staff to clarify study questions lend support to the importance of patient training to provide standardized instructions and key definitions. In all, results from our study suggest that electronic interactive training could be used as an approach to reduce inconsistencies in PRO measures and improve data quality.
Authors: Ly JJ, Durand E, Gary, S, Tuller JM, Dallabrida SM