Giving Voice to Clinical Study Participants: Development and Deployment of Sequential Patient Experience Surveys for Global Clinical Studies
| Autor: | Tammy S Ice, Nadia Thyssen, Elizabeth Manning, Mitch Herndon, Stephen Yates, Daphnee S Pushparajah, Wendy Frye |
|---|---|
| Rok vydání: | 2019 |
| Předmět: |
Questionnaires
Asia Computer science Patient engagement Health literacy 030226 pharmacology & pharmacy Social sciences Net Promoter 03 medical and health sciences 0302 clinical medicine Global studies Patient satisfaction Interim Surveys and Questionnaires Patient experience Humans Pharmacology (medical) Attitudes surveys 030212 general & internal medicine Patient participation Pharmacology Toxicology and Pharmaceutics (miscellaneous) Patient-centric Medical education Public Health Environmental and Occupational Health Benchmarking Europe Patient Outcome Assessment Patient Satisfaction Original Article |
| Zdroj: | Therapeutic Innovation & Regulatory Science |
| ISSN: | 2168-4804 |
| Popis: | Background Biopharmaceutical companies are piloting patient experience surveys (PES) to help enhance patient satisfaction with clinical studies. However, most PES have been conducted at study close-out, which can hinder recall and responsiveness, and at a limited number of sites, which restricts their applicability to global studies. Our aim was to investigate the feasibility of developing sequential PES, which would be deployed globally, and to provide practical recommendations based on our real-world experience. Methods To develop sequential PES (introductory, interim, close-out), we customized a previously developed patient experience close-out survey. Extensive input was gained from multiple stakeholders (e.g., survey experts, patient advisors, psychometricians, clinical trialists, lawyers). To deploy the PES in global studies, we prepared PES-specific ethics committee submissions, training materials (e.g., slides, videos), and PES invitation aids (postcards, digital app reminders). Results Developing and deploying sequential PES in global clinical studies was feasible. The 3-part online PES (25 to 37 questions per survey) passed health literacy testing. To facilitate benchmarking, the PES included core questions (including a Net Promoter Score question). The PES gained ethics approval and was deployed globally in 2017–2018 in 12 phase 2 and 3 clinical studies in North America, Europe, and the Asia–Pacific. Based on the real-world insights gained and the challenges encountered, we have made recommendations for PES. Conclusions Our practical recommendations on the development and deployment of sequential global PES may assist others to implement PES efficiently and effectively, allowing them to gain feedback from patients globally during clinical studies. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|
Full text from SpringerLink