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:BACKGROUND: A compelling ethical rationale supports patient engagement in healthcare research. It is also assumed that patient engagement will lead to research findings that are more pertinent to patients' concerns and dilemmas. However; it is unclear how to best conduct this process. In this systematic review we aimed to answer 4 key questions: what are the best ways to identify patient representatives? How to engage them in designing and conducting research? What are the observed benefits of patient engagement? What are the harms and barriers of patient engagement? METHODS: We searched MEDLINE, EMBASE, PsycInfo, Cochrane, EBSCO, CINAHL, SCOPUS, Web of Science, Business Search Premier, Academic Search Premier and Google Scholar. Included studies were published in English, of any size or design that described engaging patients or their surrogates in research design. We conducted an environmental scan of the grey literature and consulted with experts and patients. Data were analyzed using a non-quantitative, meta-narrative approach. RESULTS: We included 142 studies that described a spectrum of engagement. In general, engagement was feasible in most settings and most commonly done in the beginning of research (agenda setting and protocol development) and less commonly during the execution and translation of research. We found no comparative analytic studies to recommend a particular method. Patient engagement increased study enrollment rates and aided researchers in securing funding, designing study protocols and choosing relevant outcomes. The most commonly cited challenges were related to logistics (extra time and funding needed for engagement) and to an overarching worry of a tokenistic engagement. CONCLUSIONS: Patient engagement in healthcare research is likely feasible in many settings. However, this engagement comes at a cost and can become tokenistic. Research dedicated to identifying the best methods to achieve engagement is lacking and clearly needed.
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Project description:Background'Patient engagement' involves meaningful collaboration between researchers and 'patient partners' to co-create research. It helps ensure that research being conducted is relevant to its ultimate end-users. Although patient engagement within clinical research has been well documented, the prevalence and effects of patient engagement in translational preclinical laboratory research remain unclear. The aim of this scoping review is to present current patient engagement activities reported in preclinical laboratory research.MethodsMEDLINE, Embase, and grey literature were systematically searched from inception to April 2021. Studies that described or investigated patient engagement in preclinical laboratory research were included. Patient engagement activities where patients (i.e. patients, family members, caregivers or community members) provided input, or consultation on at least one element of the research process were eligible for inclusion. Study characteristics and outcomes were extracted and organized thematically.Findings32 reports were included (30 primary studies, 1 narrative review, and 1 researcher guide). Most studies engaged patients at the education or priority setting stages (n=26). The most frequently reported benefit of patient engagement was 'providing a mutual learning opportunity'. Reported barriers to patient engagement reflected concerns around 'differences in knowledge and research experience' and how this may challenge communication and limit meaningful collaboration.InterpretationPatient engagement is feasible and beneficial for preclinical laboratory research. Future work should focus on assessing the impacts of patient engagement in this area of research.FundingNone.
| S-EPMC8318845 | biostudies-literature
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:BackgroundWith healthcare striving to shift to a more person-centered delivery model, patient and family involvement must have a bigger role in shaping this. While many initiatives involving patients and family members focus on self-care, a broader understanding of patient participation is necessary. Ensuring a viable and sustainable critical number of qualified patients and family members to support this shift will be of utmost importance. The purpose of this study was to understand how health systems are intentionally investing in the training and skill development of patients and family members.MethodsPatient co-investigators and researchers conducted a scoping review of the existing literature on methods adopted by healthcare systems to build the skills and capacity of patients to participate in healthcare decision-making using a recognized methodological framework. Six electronic databases were searched to identify studies. Two independent reviewers screened titles and abstracts and full-text papers for inclusion. The research team independently extracted data. Any disagreements were resolved by achieving consensus through discussion. Quantitative and qualitative content synthesis, as well as a quality assessment, was conducted.ResultsAfter eliminating duplicates, the search resulted in 9428 abstracts. Four hundred fifty-eight articles were reviewed and 15 articles were included. Four themes emerged: forums (33%), patient instructors (20%), workshops (33%), and co-design (13%). Four of the identified studies measured the impact and overall effectiveness of the respective programs. Examples of how patient and family members were supported (invested in) included advocacy training to support future involvement in engagement activities, a training program to conduct patient-led research, involvement in an immersive experience-based co-design initiative, and involvement in training pharmacy students. Overall, these studies found positive outcomes when patients and family members were recipients of these opportunities.ConclusionsThe results of this scoping review demonstrate that an evidence base around programs to advance patient engagement is largely absent. An opportunity exists for further research to identify strategies and measures to support patient engagement in healthcare decision-making.
| S-EPMC6474065 | biostudies-literature
Project description:BackgroundThe COVID-19 pandemic has had a devastating impact on healthcare systems and care delivery, changing the context for patient and family engagement activities. Given the critical contribution of such activities in achieving health system quality goals, we undertook to address the question: What is known about work that has been done on patient engagement activities during the pandemic?ObjectiveTo examine peer-reviewed and grey literature to identify the range of patient engagement activities, broadly defined (inclusive of engagement to support clinical care to partnerships in decision-making), occurring within health systems internationally during the first six months of the COVID-19 pandemic, as well as key barriers and facilitators for sustaining patient engagement activities during the pandemic.MethodsThe following databases were searched: Medline, Embase and LitCOVID; a search for grey literature focused on the websites of professional organizations. Articles were required to be specific to COVID-19, describe patient engagement activities, involve a healthcare organization and be published from March 2020 to September 2020. Data were extracted and managed using Microsoft Excel. A content analysis of findings was conducted.ResultsTwenty-nine articles were included. Few examples of more genuine partnership with patients were identified (such as co-design and organizational level decision making); most activities related to clinical level interactions (e.g. virtual consultations, remote appointments, family visits using technology and community outreach). Technology was leveraged in almost all reported studies to interact or connect with patients and families. Five main descriptive categories were identified: (1) Engagement through Virtual Care; (2) Engagement through Other Technology; (3) Engagement for Service Improvements/ Recommendations; (4) Factors Impacting Patient Engagement; and (5) Lessons Learned though Patient Engagement.ConclusionsEvidence of how healthcare systems and organizations stayed connected to patients and families during the pandemic was identified; the majority of activities involved direct care consultations via technology. Since this review was conducted over the first six months of the pandemic, more work is needed to unpack the spectrum of patient engagement activities, including how they may evolve over time and to explore the barriers and facilitators for sustaining activities during major disruptions like pandemics.
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Project description:Community empowerment and engagement is one of the four strategic aims highlighted in the WHO strategy to prevent and control snakebite envenoming. Inappropriate health-seeking behaviours contribute to adverse outcomes, and community engagement is key in driving behavioural change. WHO has highlighted East Africa as a geographical area of concern for snakebite envenoming. The overall aim of the project is to develop a community engagement toolkit for snakebite envenoming and other NTDs. The objective of this scoping review was to identify current practices in recent community engagement in rural East Africa; the applicability of these results to snakebite envenoming are discussed. PubMed, Web of Science, PsycINFO and Google Scholar were searched from 1 January 2017 to 3 September 2020. Search terms were used to identify publications which related to rural communities and health or disease, for both humans and animals. After reviewing the full papers for all geographical areas, 112 publications were included, 30 of which were conducted in East Africa. Papers included nine different countries and covered a broad range of health topics; notably, water, sanitation and hygiene, nutrition, and maternal and child health. Only one publication considered animal health. The most common form of engagement was in the context of a group meeting, lecture, presentation, discussion or question and answer session (63.3%). A variety of locations within the community were used to engage with people, the most common being an individual's household (23.3%). Communication factors was the key influencer for engagement, both positively and negatively. Key barriers to engagement include local languages and health beliefs, literacy levels, mobile phone ownership and the level of mobile Internet coverage, burden of agricultural work and weather conditions. This study provides an extensive overview of recent public health community engagement in East Africa, which will serve as a useful resource for any group seeking to plan an intervention in remote and rural areas in East Africa. Furthermore, it serves as a guide to help tailor community engagement to snakebite envenoming.
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Project description:BackgroundWhile effective engagement of patients and families in treatment is increasingly viewed as a priority for many healthcare systems, much remains to be learned about the nature and outcomes of approaches that seek to accomplish this goal in the acute care hospital setting. Wide variability in the implementation of practices designed to promote patient and family engagement in hospitals has been noted. Approaches aimed at promoting patient and family engagement in treatment share the over-arching goal of changing behaviors of patients, families, and healthcare providers and possibly administrators. Behavior change techniques (BCTs) can be a key element of patient and family engagement approaches. This scoping review will contribute to the development of an evidence base detailing that the BCTs have potential to be effective in patient and family engagement interventions. The specific objectives of this review are to (a) identify and classify approaches used in acute care hospitals to engage patient and families in treatment according to the behavior change technique taxonomy; and (b) evaluate and synthesize the outcomes for these approaches for patients and families, healthcare providers, and health administrators/funders.MethodsThis systematic scoping review will allow us to determine the extent, range, and nature of research activity related to initiatives designed to promote patient and family engagement in care. A comprehensive electronic literature search will be conducted in MEDLINE, EMBASE, and CINAHL. Studies will be included if they report on outcomes of a structured or systematic approach to the promotion of adult inpatient and family engagement in treatment in acute care settings. Studies will be selected in a two-stage screening process (title and abstract; full text) and quality will be assessed using the mixed methods assessment tool. Data extraction will include narrative descriptions of the intervention and classification of the behavior change techniques employed.DiscussionThis review aims to identify and classify the specific behavior change techniques underpinning patient and family engagement interventions used in acute care hospital settings. By identifying the "active ingredients" in these interventions, our findings will be transferable to a wide range of acute care hospital contexts and populations.
| S-EPMC5827976 | biostudies-literature
Project description:BackgroundHealthcare services regularly receive patient feedback, most of which is positive. Empirical studies suggest that health services can use positive feedback to create patient benefit. Our aim was to map all available empirical evidence for how positive patient feedback creates change in healthcare settings.MethodsEmpirical studies in English were systematically identified through database searches (ACM Digital Library, AMED, ASSIA, CINAHL, MEDLINE and PsycINFO), forwards and backwards citation, and expert consultation. We summarise the characteristics of included studies and the feedback they consider, present a thematic synthesis of qualitative findings, and provide narrative summaries of quantitative findings.Results68 papers were included, describing research conducted across six continents, with qualitative (n = 51), quantitative (n = 10), and mixed (n = 7) methods. Only two studies were interventional. The most common settings were hospitals (n = 27) and community healthcare (n = 19). The most common recipients were nurses (n = 29). Most outcomes described were desirable. These were categorised as (a) short-term emotional change for healthcare workers (including feeling motivated and improved psychological wellbeing); (b) work-home interactional change for healthcare workers (such as improved home-life relationships); (c) work-related change for healthcare workers (such as improved performance and staff retention). Some undesirable outcomes were described, including envy when not receiving positive feedback. The impact of feedback may be moderated by characteristics of particular healthcare roles, such as night shift workers having less interaction time with patients. Some factors moderating the change created by feedback are modifiable.ConclusionFurther interventional research is required to assess the effectiveness and cost-effectiveness of receiving positive feedback in creating specific forms of change such as increases in staff retention. Healthcare managers may wish to use positive feedback more regularly, and to address barriers to staff receiving feedback.
| S-EPMC10553339 | biostudies-literature
Project description:Plain English summary:With the growing movement to engage patients in research, questions are being asked about who is engaging patients and how they are being engaged. Internationally, research groups are supporting and funding patient-oriented research studies that engage patients in the identification of research priorities and the design, conduct and uptake of research. As we move forward, we need to know what meaningful patient engagement looks like, how it benefits research and clinical practice, and what are the barriers to patient engagement?We conducted a review of the published literature looking for trials that report engaging patients in the research. We included both randomized controlled trials and non-randomized comparative trials. We looked at these trials for important study characteristics, including how patients were engaged, to better understand the practices used in trials. Importantly, we also discuss the number of trials reporting patient engagement practices relative to all published trials. We found that very few trials report any patient engagement activities even though it is widely supported by many major funding organizations. The findings of our work will advance patient-oriented research by showing how patients can be engaged and by stressing that patient engagement practices need to be better reported. Abstract: Background:Patient-Oriented Research (POR) is research informed by patients and is centred on what is of importance to them. A fundamental component of POR is that patients are included as an integral part of the research process from conception to dissemination and implementation, and by extension, across the research continuum from basic research to pragmatic trials [J Comp Eff Res 2012, 1:181-94, JAMA 2012, 307:1587-8]. Since POR's inception, questions have been raised as to how best to achieve this goal.We conducted a systematic review of randomized controlled trials and non-randomized comparative trials that report engaging patients in their research. Our main goal was to describe the characteristics of published trials engaging patients in research, and to identify the extent of patient engagement activities reported in these trials. Methods:The MEDLINE®, EMBASE®, Cinahl, PsycINFO, Cochrane Methodology Registry, and Pubmed were searched from May 2011 to June 16th, 2016. Title, abstract and full text screening of all reports were conducted independently by two reviewers. Data were extracted from included trials by one reviewer and verified by a second. All trials that report patient engagement for the purposes of research were included. Results:Of the 9490 citations retrieved, 2777 were reviewed at full text, of which 23 trials were included. Out of the 23 trials, 17 were randomized control trials, and six were non-randomized comparative trials. The majority of these trials (83%, 19/23) originated in the United States and United Kingdom. The trials engaged a range of 2-24 patients/ community representatives per study. Engagement of children and minorities occurred in 13% (3/23) and 26% (6/23) of trials; respectively. Engagement was identified in the development of the research question, the selection of study outcomes, and the dissemination and implementation of results. Conclusions:The prevalence of patient engagement in patient-oriented interventional research is very poor with 23 trials reporting activities engaging patients. Research dedicated to determining the best practice for meaningful engagement is still needed, but adequate reporting measures also need to be defined.
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