Project Details
Clinical research is a complex and quickly evolving branch of healthcare that has traditionally been utilized to investigate novel drugs, devices, and biologics in humans. Unfortunately, the past 20 years of clinical research has been characterized by significant increases in the number and complexity of protocol design procedures for phases I, II, and III of clinical trials [1]. This increase is associated with fold changes in duration and costs to conduct a trial from initiation to successful study completion, if it is completed at all [1]. A major concern regarding increasing trial complexity, cost, and time-commitment is a lack of patient centricity and subsequent patient interest, buy-in, enrollment, and satisfaction [2]. In a study by Nipp Et. Al., patient interest and buy-in is described as one of several reasons why so many clinical trials are struggling to enroll and reach their primary objective, in conjunction with financial barriers, logistical concerns, and restrictive study criteria [2]. In addition to working to simplify design, logistical, and financial barriers, novel methods to engage patients and gain buy-in are needed.
Many organizations, such as the Patient-Centered Outcomes Research Institute (PCORI) and Patients as Partners, are working to develop patient involvement methods to increase patient involvement in the study development process and subsequent study enrollment and satisfaction [3, 4]. These organizations have introduced a new way of thinking about study participants, with more emphasis being placed on them as partners and stakeholders in the clinical research development process [3]. Specifically, patients are being involved discussions with researchers regarding study topic decisions, questions development, design, data collection, data analysis, interpretation, and dissemination to varying degrees [3]. In addition to providing valuable insights and feedback, Deverka Et. Al. has noted that stakeholder engagement (including patients) is fundamental to comparative effectiveness research (CER) [5]. Furthermore, stakeholder engagement is key to ensure that current orthopedic research foci are aligned with the needs of current patients.
There is limited research in the literature, and even less in the orthopedic literature, that characterize the methods and process of appropriately engaging patients as partners and stakeholders. However, one paper by Deverka Et. Al. defined stakeholder engagement as:
An iterative process of actively soliciting the knowledge, experience, judgement, and values of individuals selected to represent a broad range of direct interests in a particular issue for the dual purpose of creating a shared understanding and making relevant, transparent, and effective decisions [5].
Going a step further, Deverka Et. Al. have described a conceptual model for stakeholder engagement that was adapted from the National Research Council [5]. In summary, this model ties evidence-based questions to methodical input from stakeholders that informs decision-making and generates outcomes [5]. The exact methods to collect input from stakeholders is left to individual applications of the model. In a perfect world, this might be one-on-one meetings between researchers, patients, and other stakeholders. Unfortunately, that option is not feasible to gain feedback from hundreds or even thousands of stakeholders over time.
Thus, the purpose of this study is to instead collect stakeholder input using a prospective, qualitative, anonymous survey that assesses the research perspectives of orthopedic patients and evaluates this method as a potential effective strategy to engage patients as stakeholders throughout the research development process.
Project Highlights
✅ Course completed with an ‘A’
✅ Academic Individual Capstone Project - Part of WFU M.S. Clinical Research Management (https://school.wakehealth.edu/education-and-training/graduate-programs/clinical-research-management-ms)
✅ Novel approach to assessing patient interest in involvement in clinical research as stakeholders
✅ Study ongoing at the Andrews Research & Education Foundation (https://andrewsref.org/)
