Background & Aims
Pain clinical trials often result in failure due to inconsistent and unreliable patient reporting.1 Training patients and site personnel in accurate reporting and placebo response has been shown to improve assay sensitivity.2
Despite low cost and burden and evidence for improved outcomes, patient and site training has not been widely adopted. Sponsors and sites commonly cite logistical complexity and patient burden as barriers to training implementation. There is, however, a lack of research exploring how patients perceive such training.
The shift towards a patient-centered approach in trial design highlights the need to understand the patient experience.3 This approach could potentially lead to more successful trial outcomes and better patient compliance by incorporating the patient’s voice. In line with this approach, the current study aims to understand patient and staff receptivity to, perceived usefulness of, and satisfaction with training in pain clinical trials.
Methods
Online training for accurate reporting and/or placebo response was implemented for 24 clinical trials across a variety of pain indications. As part of training during these trials, 12,680 subjects and 5,097 site staff answered 5 training evaluation questions upon completion of the training module. Responses were given on 5-point Likert scales, ranging from ‘Strongly Disagree’ to ‘Strongly Agree’.
Subjects were asked about (1) ease in understanding training content, (2) perceived utility of the content, (3) ability to apply the training, (4) importance of the training content, and (5) familiarity with the topics prior to training completion.
Site staff reported (1) ease in understanding content, (2) familiarity with content prior to training completion, (3) understanding how concepts apply to subjects, (4) confidence in helping subjects apply concepts, and (5) their intention to apply the material when working with subjects.
Responses of “agree” and “strongly agree” were aggregated.
Results
Among subjects, 90.2% reported the training content was easy to understand by responding “agree” or “strongly agree.” Approximately 90.4% reported that the training improved understanding of concepts of accurate reporting and placebo response, 91.6% reported feeling confident in their ability to apply the concepts learned in the training, and 91.1% reported that the training helped them understand the importance of providing accurate and internally-focused responses during the trial. Approximately 57.9% of participants reported that they were not aware of the concepts prior to the training.
Among site staff, 90.7% reported content was easy to understand, 89.6% reported understanding how concepts apply to subjects, 92.8% reported confidence in training subjects on concepts, and 89.6% reported intent to apply these concepts in their clinical research. Approximately 48.9% of site staff reported that they were not aware of the presented concepts prior to training.
Conclusions
Training modules were generally well-received by both research subjects and site staff. Subjects reported high levels of satisfaction, content comprehension, and confidence in applying what they learned. Similarly, site staff reported finding the trainings useful and intention to use concepts with subjects.
Notably, both subjects and site staff who were familiar with the concepts found the trainings useful, suggesting that the training successfully reinforced previously learned concepts of accurate reporting and placebo response.
These results suggest that this type of training was not perceived by users as burdensome or onerous, even when they were familiar with the training content. Although further evaluation is needed to determine if users who reported high satisfaction and intent to apply the training provided better quality data, these findings indicate that the benefits of patient and staff training in pain clinical trials outweigh potential costs and concerns.
References
1.Dworkin, Robert H., et al. “Considerations for Improving Assay Sensitivity in Chronic Pain Clinical Trials: IMMPACT Recommendations.” Pain, vol. 153, no. 6, June 2012, pp. 1148–1158, https://doi.org/10.1016/j.pain.2012.03.003.
2.Erpelding, Nathalie, et al. “Placebo Response Reduction and Accurate Pain Reporting Training Reduces Placebo Responses in a Clinical Trial on Chronic Low Back Pain.” The Clinical Journal of Pain, vol. Publish Ahead of Print, 24 Aug. 2020, https://doi.org/10.1097/ajp.0000000000000873. Accessed 16 Oct 2020.
3.Sharma, Neha Shankar. “Patient Centric Approach for Clinical Trials: Current Trend and New Opportunities.” Perspectives in Clinical Research, vol. 6, no. 3, 2015, p. 134, https://doi.org/10.4103/2229-3485.159936. Accessed 10 Nov. 2019.
Presenting Author
Amee Patel
Poster Authors
Topics
- Evidence, Clinical Trials, Systematic Review, Guidelines, and Implementation Science