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The Rules of Engagement: CTTI Recommendations for Successful Collaborations Between Sponsors and Patient Groups Around Clinical Trials.

ABSTRACT: OBJECTIVE:To identify the elements necessary for successful collaboration between patient groups and academic and industry sponsors of clinical trials, in order to develop recommendations for best practices for effective patient group engagement. METHODS:In-depth interviews, informed by a previously reported survey, were conducted to identify the fundamentals of successful patient group engagement. Thirty-two respondents from 3 sectors participated: patient groups, academic researchers, and industry. The findings were presented to a multistakeholder group of experts in January 2015. The expert group came to consensus on a set of actionable recommendations for best practices for patient groups and research sponsors. RESULTS:Interview respondents acknowledged that not all patient groups are created equal in terms of what they can contribute to a clinical trial. The most important elements for effective patient group engagement include establishing meaningful partnerships, demonstrating mutual benefits, and collaborating as partners from the planning stage forward. Although there is a growing appreciation by sponsors about the benefits of patient group engagement, there remains some resistance and some uncertainty about how best to engage. Barriers include mismatched expectations and a perception that patient groups lack scientific sophistication and that "wishful thinking" may cloud their recommendations. CONCLUSIONS:Patient groups are developing diverse skillsets and acquiring assets to leverage in order to become collaborators with industry and academia on clinical trials. Growing numbers of research sponsors across the clinical trials enterprise are recognizing the benefits of continuous and meaningful patient group engagement, but there are still mindsets to change, and stakeholders need further guidance on operationalizing a new model of clinical trial conduct.

SUBMITTER: Bloom D

PROVIDER: S-EPMC5846850 | biostudies-literature | 2018 Mar

REPOSITORIES: biostudies-literature

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The Rules of Engagement: CTTI Recommendations for Successful Collaborations Between Sponsors and Patient Groups Around Clinical Trials.

Bloom Diane D Beetsch Joel J Harker Matthew M Hesterlee Sharon S Moreira Paulo P Patrick-Lake Bray B Selig Wendy W Sherman Jeffrey J Smith Sophia K SK Valentine James E JE Roberts Jamie N JN

Therapeutic innovation & regulatory science 20170727 2

<h4>Objective</h4>To identify the elements necessary for successful collaboration between patient groups and academic and industry sponsors of clinical trials, in order to develop recommendations for best practices for effective patient group engagement.<h4>Methods</h4>In-depth interviews, informed by a previously reported survey, were conducted to identify the fundamentals of successful patient group engagement. Thirty-two respondents from 3 sectors participated: patient groups, academic resear ...[more]

PMID: 29714514

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Project description:Patient portals have shown promise in engaging individuals in self-management of chronic conditions by allowing patients to input and track health information and exchange secure electronic messages with their providers. Past studies have identified patient barriers to portal use including usability issues, low health literacy, and concerns about loss of personal contact as well as provider concerns such as increased time spent responding to messages. However, to date, studies of both patient and provider perspectives on portal use have focused on the pre-implementation or initial implementation phases and do not consider how these issues may change as patients and providers gain greater experience with portals.Our study examined the following research question: Within primary care offices with high rates of patient-portal use, what do experienced physician and patient users of the ambulatory portal perceive as the benefits and challenges of portal use in general and secure messaging in particular?This qualitative study involved 42 interviews with experienced physician and patient users of an ambulatory patient portal, Epic's MyChart. Participants were recruited from the Department of Family Medicine at a large Academic Medical Center (AMC) and included providers and their patients, who had been diagnosed with at least one chronic condition. A total of 29 patients and 13 primary care physicians participated in the interviews. All interviews were conducted by telephone and followed a semistructured interview guide. Interviews were transcribed verbatim to permit rigorous qualitative analysis. Both inductive and deductive methods were used to code and analyze the data iteratively, paying particular attention to themes involving secure messaging.Experienced portal users discussed several emergent themes related to a need for greater clarity on when and how to use the secure messaging feature. Patient concerns included worry about imposing on their physician's time, the lack of provider compensation for responding to secure messages, and uncertainty about when to use secure messaging to communicate with their providers. Similarly, providers articulated a lack of clarity as to the appropriate way to communicate via MyChart and suggested that additional training for both patients and providers might be important. Patient training could include orienting patients to the "rules of engagement" at portal sign-up, either in the office or through an online tutorial.As secure messaging through patient portals is increasingly being used as a method of physician-patient communication, both patients and providers are looking for guidance on how to appropriately engage with each other using this tool. Patients worry about whether their use is appropriate, and providers are concerned about the content of messages, which allow them to effectively manage patient questions. Our findings suggest that additional training may help address the concerns of both patients and providers, by providing "rules of engagement" for communication via patient portals.

Project description:BackgroundDespite substantial awareness that certain groups (e.g. ethnic minorities) are under-represented and under-served in trials, limited progress has been made in addressing this. As well as a public service and ethical duty to recruit and engage under-served groups in relevant research, importantly, there are clear scientific benefits, for example, increased generalisability. The key aims of the current study were to explore the following: general barriers and facilitators to enhancing the recruitment of under-served groups into trials, the usability and value of a specific tool (INCLUDE Ethnicity Framework) to support engagement and recruitment of under-served groups, and ways of engaging diverse patient, public and community involvement and engagement (PCIE) groups.MethodsFirstly, researchers completed a brief survey in relation to a specific trial in which they were involved (N = 182, 38% response rate). A second stage involved sampling survey respondents and asking them to complete the INCLUDE Ethnicity Framework and then a remote semi-structured interview (N = 15). Qualitative data were analysed using thematic analysis. Finally, we conducted a consultation process with PCIE contributors primarily to develop guidelines for discussing the INCLUDE Ethnicity Framework with PCIE representatives.ResultsResearchers recognised the importance of increasing engagement and recruitment of under-served groups within trials, but varied in their knowledge, ability and commitment to implementation in practice. The INCLUDE Ethnicity Framework was described by some as raising their awareness of how inclusion could be improved. Respondents highlighted a need for shared resources and wider structural change to facilitate such engagement. PCIE was identified, in the survey and interviews, as the most common method of trying to improve recruitment of under-served groups. However, researchers also commonly highlighted that PCIE groups were sometimes not very diverse.ConclusionsThere is a need for researchers to consider the funding and time resources required for diverse and inclusive recruitment to trials and for funders to enable this. The INCLUDE Ethnicity Framework can help to raise awareness of inclusion challenges. This study indicates that it is important to take proactive steps to involve relevant under-served groups in PCIE and practical suggestions are made to facilitate this.

Project description:BackgroundA 2017 systematic review suggested patient engagement in clinical trials has been limited, with little active engagement in trial design or data analysis, interpretation or dissemination. Additionally, there remains limited sex/gender reporting in clinical trial research.ObjectivesThe overall goal of this project was to disseminate sex/gender knowledge and build capacity for patient engagement in clinical trials. Specific objectives were to (1) create capacity and identify opportunities for patient engagement in clinical trials and sponsor- or investigator-led activities (e.g. clinical trial design and conduct); and (2) enhance new/early investigator sex/gender knowledge and skills related to patient-oriented research (POR).MethodsWe used the Canadian Institutes of Health Research Strategy for Patient-Oriented Research (SPOR) Capacity Development Framework and the SPOR Patient Engagement Framework to guide three phases of this project: (1) conduct a scoping review using methods described by the Evidence for Policy and Practice Information (EPPI) and the Coordinating Centre at the Institute of Education (Phase 1); (2) host a 1-day POR consultation workshop (Phase 2); and (3) deliver a new/early investigator POR training day (Phase 3). Six electronic databases (CINAHL, MEDLINE, EMBASE, PsychInfo, the Cochrane Library, and AMED) were searched from 1996 using keywords and Medical Subject Heading (MeSH) terms in accordance with the International Association for Public Participation (IAP2) and the search criteria in the bibliographic databases. Standard approaches were used to search the grey literature.ResultsA total of 79 studies and over 150 websites were subject to data abstraction by team members, capturing information on sex/gender and SPOR's patient engagement guiding principles of inclusiveness, support, mutual respect, and co-building. Results were presented to 32 key stakeholders at the consultation workshop and input was sought on next steps using nominal group techniques. Based on the plethora of existing POR resources, relevant POR information from the scoping review was collated into two decision aids (patient and investigator) to determine readiness to engage with/as a patient partner in a clinical trial. The decision aids were presented at a POR training day with 88 new/early investigators, clinicians, patient partners and decision makers. The decision aids showed 'good' usability, assessed using the System Usability Scale (SUS). Attendees thought the decision aids were engaging, they increased their understanding of sex/gender, patient engagement and POR, and they would recommend them to others. POR principles and practices were integrated across all phases of the project. Patient partners (1) identified research priorities/search terms; (2) collected/analyzed data; (3) designed the patient partner decision aid; and (4) disseminated the results through presentation.ConclusionOur digital patient partner and investigator decision aids are the first to provide information technology to deliver sex/gender, POR knowledge, and decision support beyond the traditional decision aids used for health screening and/or treatment decisions. The decision aids have the potential to make a significant contribution to Canada's Strategy for POR and support the collaborative efforts of patients and investigators to build a sustainable, accessible and equitable health care system.

Dataset Information

The Rules of Engagement: CTTI Recommendations for Successful Collaborations Between Sponsors and Patient Groups Around Clinical Trials.

Publications

The Rules of Engagement: CTTI Recommendations for Successful Collaborations Between Sponsors and Patient Groups Around Clinical Trials.

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