Practices of patient engagement in drug development: a systematic scoping review.
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ABSTRACT: Background
During the past decade, patient engagement (PE) has attracted significant attention in the field of drug development. Readiness to accept the central importance of patients' knowledge and contributions has become evident. This study aimed to synthesize evidence on the current state of PE in drug development: what is actually being done and how.Methods
A systematic scoping review was conducted based on a PRISMA-informed protocol. Search was performed in PubMed, EMBASE and Web of Science, covering the period between 2011 and 2021. For analysis of extracted data, we developed a framework for analyzing PE in Drug Development. The Framework distinguishes a number of different PE types that take place at different stages of drug development and are characterized by the different degrees of power patients have in the process. It allowed us to assess depth and intensity of PE initiatives included in this review.Results
Most included PE initiatives took place at the stage of designing studies (40 in total). At this stage drug development goals are already set, but the mode of reaching them has not yet been fully determined. PE initiatives on the finetuning details stage followed (16 in total). The finetuning details stage covers the last parts of the drug development trajectory, when only relatively minor issues are still open for patients' contributions. The least numerous were PE initiatives on the stage of setting up R&D program (13 in total). This stage refers to the early steps in drug development where PE has the potential to make the most impact on shaping the subsequent process. In terms of intensity of engagement, most PE initiatives included in this review align with consultation and involvement types, 26 and 30 initiatives, respectively. Partnership was less frequent in the published accounts of PE (13 initiatives).Conclusions
This review delineated a contemporary landscape of PE in drug development. Although attention to PE in drug development is relatively recent, a wide range of PE practices has already been initiated. The results indicate the necessity of distinguishing between different types of PE in order to understand consequences of choices regarding depth and intensity of PE.
SUBMITTER: Zvonareva O
PROVIDER: S-EPMC9243835 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:ObjectivesTo explore the extent of patient engagement in the development of best practice reports related to transitions from hospital to home.DesignScoping review.Data sourcesElectronic databases (MEDLINE, EMBASE, CINAHL, Scopus, Trip Database, DynaMed Plus and Public Health Plus) and multiple provincial regulatory agency and healthcare organisation websites.Eligibility criteriaWe included best practice reports related to the transition from hospital to a long-term care facility, community dwelling or rehabilitation centre. We included documents disseminated in English between 1947 and 2019.Data extraction and synthesisTwo independent reviewers screened for eligibility and one extracted and analysed data using a data extraction tool we developed based on established patient engagement frameworks. Only records actively engaging patients were analysed (n=11). The methodological quality of actively engaging patients was assessed using domain 2 (item 5) of stakeholder involvement from the Appraisal of Guidelines for Research and Evaluation II (AGREE II) tool.ResultsThe search yielded 1921 citations of which 23 met the inclusion criteria and were included for narrative synthesis. These were disseminated between 1995 and 2019, with 18 (78%) published after 2010. Most were conducted in North America (USA 43%, Canada 22%), Europe (UK 30%) and Australia (4%). Eleven (48%) actively involved patients, of which only two involved patients across all stages of development. Most involved patients through direct or indirect consultation. The mean AGREE II domain 2 item 5 score (of those that actively engaged patients) was 5.9 out of 7.ConclusionsOnly half of existing best practice reports related to the transition from hospital to home actively involved patients in report development. However, the extent of patient engagement has been increasing over time. More organisations should strive to engage patients throughout the best practice development process and provide patients with opportunities for shared leadership.
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Project description:OBJECTIVES:Patient engagement (PE) improves patient, organisation and health system outcomes, but most research is based on primary care. The primary purpose of this study was to describe the characteristics of published empirical research that evaluated PE in hospital health service improvement. DESIGN:Scoping review. METHODS:Five databases were searched from 2006 to September 2016. English language studies that evaluated patient or provider beliefs, participation in PE, influencing factors or impact were eligible. Screening and data extraction were done in triplicate. PE characteristics, influencing factors and impact were extracted and summarised. RESULTS:From a total of 3939 search results, 227 studies emerged as potentially relevant; of these, 217 were not eligible, and 10 studies were included in the review. None evaluated behavioural interventions to promote or support PE. While most studies examined involvement in standing committees or projects, patient input and influence on decisions were minimal. Lack of skill and negative beliefs among providers were PE barriers. PE facilitators included careful selection and joint training of patients and providers, formalising patient roles, informal interaction to build trust, involving patients early in projects, small team size, frequent meetings, active solicitation of patient input in meetings and debriefing after meetings. Asking patients to provide insight into problems rather than solutions and deploying provider champions may enhance patient influence on hospital services. CONCLUSIONS:Given the important role of PE in improving hospital services and the paucity of research on this topic, future research should develop and evaluate behavioural interventions for PE directed at patients and providers informed by the PE barriers and facilitators identified here. Future studies should also assess the impact on various individual and organisational outcomes.
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Project description:BackgroundPatients can play a key role in delivering safe care by becoming actively involved in their health care. This study aimed at reviewing the literature for evidence of patients' and families' engagement in patient safety in the Eastern Mediterranean Region (EMR).MethodsWe conducted a scoping review of the literature published in English using PubMed, Medline, CINAHL, Scopus, ISI Web of Science, and PsycINFO until June 2023.ResultsA total of 9019 studies were screened, with 22 meeting the inclusion criteria. Our review found few published studies of patient and family engagement in patient safety research in the EMR. Thirteen studies explored the attitudes, perceptions, and/or experiences / preferences of patients, families, and healthcare providers (HCPs) regarding patient engagement in patient safety. Nine publications reported patient involvement in patient safety activities at varying levels. Three categories of factors were identified that may affect patient involvement: patient-related (e.g., lack of awareness on their role in preventing harms, unwillingness to challenge HCPs' authority, and cultural barriers); HCP-related (e.g., negative attitudes towards patient engagement, poor patient-provider communication, and high workload); and healthcare setting-related (e.g., lack of relevant policies and guidelines, lack of training for patients, and HCPs, and lack of patient-centered approach).ConclusionThis review highlighted limitations in the current literature on patient and family engagement in patient safety in the EMR, including both the depth of evidence and clarity of concepts. Further research is needed to explore how to actively involve patients and their families, as well as to determine whether such involvement translates into improved safety in practice.
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Project description:BackgroundPeople with multimorbidity are increasingly engaged, enabled, and empowered to take responsibility for managing their health status. The purpose of the study was to systematically review and appraise the psychometric properties of tools measuring patient engagement in adults with multimorbidity and their applicability for use within engagement programs.MethodsPubMed, Scopus, Web of Science, and PsycInfo were searched from inception to 1 July 2021. Gray literature was searched using EBSCO host-database "Open dissertation". The reference lists of studies meeting the inclusion criteria were searched to identify additional eligible studies. The screening of the search results and the data extraction were performed independently by two reviewers. The methodological quality of the included studies was evaluated with the COSMIN checklist. Relevant data from all included articles were extracted and summarized in evidence synthesis tables.ResultsTwenty articles on eight tools were included. We included tools that measure all four dimensions of patient engagement (i.e., engagement, empowerment, activation, and participation). Their psychometric properties were analyzed separately. Most tools were developed in the last 10 years in Europe or the USA. The comparison of the estimated psychometric properties of the retrieved tools highlighted a significant lack of reliable patient engagement measures for people with multimorbidity. Available measures capture a diversity of constructs and have very limited evidence of psychometric properties that are vital for patient-reported measures, such as invariance, reliability, and responsiveness.ConclusionThis review clarifies how patient engagement, as operationalized in measures purporting to capture this concept, overlaps with, and differs from other related constructs in adults with multimorbidity. The methodological quality of psychometric tools measuring patient engagement in adults with multimorbidity could be improved.Systematic review registrationhttps://www.crd.york.ac.uk/prospero/display_record.php?RecordID=259968, identifier CRD42021259968.
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Project description:BackgroundPatient engagement has emerged as a key focus in the research literature to facilitate patients' recovery. The term is commonly used by researchers, yet without working definitions. This lack of clarity is further complicated by the interchangeable use of a few terms.ObjectivesThis systematic review aimed at identifying how patient engagement was conceptualised and operationalised in perioperative settings.MethodsMEDLINE, EMBASE, CINAHL and the Cochrane Library were searched for publications in English discussing patient engagement during the perioperative phase. Three reviewers conducted study selection and methodological assessment using Joanna Briggs Institute mixed methods review framework. Reflexive thematic analysis was used to analyse qualitative data and descriptive analysis for quantitative data.FindingsTwenty-nine studies were included with a total sample of 6289. Study types included qualitative (n = 14) and quantitative (n = 15) with different types of surgery. Sample sizes ranged from n = 7 to n = 1315. Only 38% (n = 11) of included studies offered an explicit definition. Four themes associated with operationalisation included provision of information, which was most studied theme, communication, decision-making and action-taking behaviours. All four themes were interconnected and co-dependent on each other.ConclusionsPatient engagement in perioperative settings is a complex and multifaceted concept. The conceptual void in the literature calls for more theoretically informed and comprehensive approaches to researching surgical patient engagement. Future research should aim to better understand the factors that influence patient engagement, as well as the impact of different forms of engagement on patient outcomes through the whole surgical journey of a patient.
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