Patient Involvement Activities Research Articles

Involving patients to promote patient safety in healthcare facilities in Germany

Background: Proactive involvement of patients in the design of safe care is a WHO-defined goal of the current decade. This paper investigated (a) which patient involvement activities and measures are implemented in German health care facilities for patient safety, and (b) which recommendations for action can be derived for our health care facilities. Aim and method: A literature and Internet search was conducted on institutional practices and organizational activities in Germany to improve patient safety with the involvement of patients. Interviews with five experts were conducted who advised our approach. An agenda for future research projects and first recommendations for clinical practice was formulated afterwards. Results: The evidence base on established measures to incorporate patient perspectives into the strategic promotion of patient safety in healthcare facilities in Germany is scarce and inconsistent. Patient surveys and the use of patient advocates are common. It remains unclear how patient councils as well as self-help groups have the potential to contribute to the promotion of patient safety in practice. Conclusions and agenda: An agenda is proposed. A more in-depth empirical survey and description of the situation in Germany, taking into account the experience of experts from clinical practice, is necessary to obtain a complete picture of the currently established measures for patient involvement, to uncover potential for realization and to define necessary framework conditions.

Recommendations for patient involvement in health technology assessment in Central and Eastern European countries.

Meaningful patient involvement in health technology assessment (HTA) is essential in ensuring that the interests of the affected patient population, their families, and the general public are accurately reflected in coverage and reimbursement decisions. Central and Eastern European (CEE) countries are generally at less advanced stages of implementing HTA, which is particularly true for patient involvement activities. As part of the Horizon2020 HTx project, this research aimed to form recommendations for critical barriers to patient involvement in HTA in CEE countries. Built on previous research findings on potential barriers, a prioritisation survey was conducted online with CEE stakeholders. Recommendations for prioritised barriers were formed through a face-to-face workshop by CEE stakeholders and HTx experts. A total of 105 stakeholders from 13 CEE countries completed the prioritisation survey and identified 12 of the 22 potential barriers as highly important. The workshop had 36 participants representing 9 CEE countries, and 5 Western European countries coming together to discuss solutions in order to form recommendations based on best practices, real-life experience, and transferability aspects. Stakeholder groups involved in both phases included HTA organisation representatives, payers, patients, caregivers, patient organisation representatives, patient experts, health care providers, academic and non-academic researchers, health care consultants and health technology manufacturers/providers. As a result, 12 recommendations were formed specified to the CEE region's context, but potentially useful for a broader geographic audience. In this paper, we present 12 recommendations for meaningful, systematic, and sustainable patient involvement in HTA in CEE countries. Our hope is that engaging more than a hundred CEE stakeholders in the study helped to spread awareness of the importance and potential of patient involvement and that the resulting recommendations provide tangible steps for the way forward. Future studies shall focus on country-specific case studies of the implemented recommendations.

Reporting of patient involvement: a mixed-methods analysis of current practice in health research publications using a targeted search strategy

ObjectivesTo evaluate the extent and quality of patient involvement reporting in examples of current practice in health research.DesignMixed-methods study. We used a targeted search strategy across three cohorts to identify...

Comparing the acceptability of total diet replacement and food-based low energy diets for type 2 diabetes remission amongst South Asians: a public and patient involvement activity.

With type 2 diabetes prevalence rising, low energy diets (total diet replacement and food-based low energy diets) are increasingly used to induce weight loss and achieve diabetes remission. The effectiveness of these diets has been primarily tested in the UK white population but not in the south Asian population at high risk of diabetes. Obtaining the opinion of members of the community on what would constitute a culturally acceptable diet is essential for successful interventions aiming to achieve diabetes remission in south Asians. We organised two patient and public involvement activities in the North West of England to understand views of people from the south Asian population on whether low energy diets (850 Kcal) in the form of total diet replacement or food-based meals, are acceptable dietary interventions to achieve type 2 diabetes remission. Thirteen people, with either type 2 diabetes or having someone with diabetes in the family attended a virtual or a face-to-face meeting. Low energy total diet replacement in the form of soups and shakes was considered unacceptable, while there was a preference for a culturally tailored low energy food-based diet. Ready-made portion controlled catered meals were suggested as a likely approach to improve adherence. This work provided valuable insights to shape a future study looking at the feasibility of a catered meal low-energy dietary intervention to induce T2D remission in primary care within the south Asian population.

Potential Barriers of Patient Involvement in Health Technology Assessment in Central and Eastern European Countries.

Patients' perspectives are important to identify preferences, estimate values and appreciate unmet medical needs in the process of research and development and subsequent assessment of new health technologies. Patient and public involvement in health technology assessment (HTA) is essential in understanding and assessing wider implications of coverage and reimbursement decisions for patients, their relatives, caregivers, and the general population. There are two approaches to incorporating the patients' voice in HTA, preferably used in a mix. In the first one, patients, caregivers and/or their representatives directly participate at discussions in different stages of the HTA process, often at the same table with other stakeholders. Secondly, patient involvement activities can be supported by evidence on patient value and experience collected directly from patients, caregivers and/or their representatives often by patient groups Patient involvement practices, however, are limited in Central and Eastern European (CEE) countries without clear methodology or regulatory mechanisms to guide patient involvement in the HTA process. This poses the question of transferability of practices used in other countries, and might call for the development of new CEE-specific guidelines and methods. In this study we aim to map potential barriers of patient involvement in HTA in countries of the CEE region.

Comparing the acceptability of total diet replacement and food-based low energy diets for type 2 diabetes remission amongst South Asians: a public and patient involvement activity

Background: With type 2 diabetes prevalence rising, low energy diets (total diet replacement and food-based low energy diets) are increasingly used to induce weight loss and achieve diabetes remission. The effectiveness of these diets has been primarily tested in the UK white population but not in the south Asian population at high risk of diabetes. Obtaining the opinion of members of the community on what would constitute a culturally acceptable diet is essential for successful interventions aiming to achieve diabetes remission in south Asians. Methods: We organised two patient and public involvement activities in the North West of England to understand views of people from the south Asian population on whether low energy diets (850 Kcal) in the form of total diet replacement or food-based meals, are acceptable dietary interventions to achieve type 2 diabetes remission. Results: Thirteen people, with either type 2 diabetes or having someone with diabetes in the family attended a virtual or a face-to-face meeting. Low energy total diet replacement in the form of soups and shakes was considered unacceptable, while there was a preference for a culturally tailored low energy food-based diet. Ready-made portion controlled catered meals were suggested as a likely approach to improve adherence. Conclusions: This work provided valuable insights to shape a future study looking at the feasibility of a catered meal low-energy dietary intervention to induce T2D remission in primary care within the south Asian population.

Comparing the acceptability of total diet replacement and food-based low energy diets for type 2 diabetes remission amongst South Asians: a public and patient involvement activity

Background: With type 2 diabetes prevalence rising, low energy diets (total diet replacement and food-based low energy diets) are increasingly used to induce weight loss and achieve diabetes remission. The effectiveness of these diets has been primarily tested in the UK white population but not in the south Asian population at high risk of diabetes. Obtaining the opinion of members of the community on what would constitute a culturally acceptable diet is essential for successful interventions aiming to achieve diabetes remission in south Asians. Methods: We organised two patient and public involvement activities in the North West of England to understand views of people from the south Asian population on whether low energy diets (850 Kcal) in the form of total diet replacement or food-based meals, are acceptable dietary interventions to achieve type 2 diabetes remission. Results: Thirteen people, with either type 2 diabetes or having someone with diabetes in the family attended a virtual or a face-to-face meeting. Low energy total diet replacement in the form of soups and shakes was considered unacceptable, while there was a preference for a culturally tailored low energy food-based diet. Ready-made portion controlled catered meals were suggested as a likely approach to improve adherence. Conclusions: This work provided valuable insights to shape a future study looking at the feasibility of a catered meal low-energy dietary intervention to induce T2D remission in primary care within the south Asian population.

The mutual benefits of patient and public involvement in research: an example from a feasibility study (MoTaStim-Foot)

BackgroundPatient and public involvement (PPI) in research has increased steadily over the last two decades and is now both expected and appropriately resourced by many funding bodies, including the National Institute for Health Research (NIHR). However, PPI in research occurs in many different capacities and numerous frameworks exist for reporting or appraising patient involvement activities. The aim of this article is to describe processes involving PPI contributions to an NIHR-funded mixed-methods feasibility study (MoTaStim-Foot). Details of PPI advisors’ input, from initial identification and prioritisation of research ideas, to research delivery and dissemination, are discussed.MethodsExtensive PPI for MoTaStim-Foot is reported, with consideration of Research Design Service (RDS) advice for PPI for research, involving identifying and prioritising: design; grant proposal development; undertaking/managing research; analysing and interpreting; dissemination; implementation; monitoring and evaluation. Two PPI workshops were undertaken; success in meeting UK standards for public involvement was audited against specific success criteria by two researchers, with discussion and consideration regarding how well our PPI achieved inclusive opportunities, working together, support and learning, governance, communications and impact. How PPI can be improved for future trials was also considered. Although the advantages of PPI for researchers were considered, the benefits for PPI advisors were also analysed.ResultsUK standards for public involvement were achieved, along with seven relevant research processes suggested by the RDS. PPI advisor contributions: informed study design; contributed to successful funding; enhanced trial delivery by informing participant information sheets and daily diaries; added value through undertaking note-taker roles in focus groups and helping to analyse focus group transcripts; and assisted in dissemination. However, benefits were mutual with PPI advisors reporting feeling valued and respected, a sense of pride with renewed confidence and purpose in life.ConclusionsImportance and value of PPI, to researchers and patient advisors, have been highlighted, reinforcing the benefits of working in partnership with PPI advisors.Trial registration ISRCTN 13676183; Central Portfolio Management System ID 30449. Registered 02/01/2015, https://www.isrctn.com/ISRCTN13676183.

Comparing the acceptability of total diet replacement and food-based low-calorie diets for type 2 diabetes remission amongst Southeast Asians: a public and patient involvement activity

Background: With type 2 diabetes prevalence rising at alarming rates, low-calorie diets (total diet replacement and food-based low-calorie diets) are increasingly used to induce weight loss and achieve diabetes remission. The effectiveness of these diets has been primarily tested in the UK white population but not in the Southeast Asian population at high risk of diabetes. Obtaining the opinion of members of the community on what would constitute a culturally acceptable diet is essential for successful interventions aiming to achieve diabetes remission in the southeast Asian population. Methods: We organised two patient and public involvement activities in the North West of England to understand views of people from the Southeast Asian population on whether low-calorie diets (850 Kcal) in the form of total diet replacement or food-based meals, are acceptable dietary interventions to achieve diabetes remission. Results: Thirteen people, with either type 2 diabetes or having someone with diabetes in the family attended a virtual or a face-to-face meeting. Low-calorie total diet replacement in the form of soups and shakes was considered unacceptable, while there was a preference for a culturally tailored low-calorie food-based diet. Ready-made portion controlled catered meals were suggested as an excellent approach to improve adherence. Conclusions: This work provided valuable insights to shape a future study looking at the feasibility to reverse diabetes in primary care through dietary intervention in the Southeast Asian population.

The conect4children (c4c) Consortium: Potential for Improving European Clinical Research into Medicines for Children.

The need for information about new and existing drugs used in children was recognized in the European Union (EU) with the implementation of the Paediatric Regulation in 2007. In 2017, the 10-year review of the Paediatric Regulation identified barriers to the conduct of clinical trials, including delays in setting up and completing paediatric trials. Across Europe, the difficulties with clinical research are compounded by variation within countries and between countries. Ethics and regulatory review have national specificities. This paper describes the Collaborative Network for European Clinical Trials for Children (conect4children, c4c), which addresses selected difficulties in the design and conduct of paediatric clinical trials. c4c is a time-limited public–private consortium funded by the Innovative Medicines Initiative (IMI2). The elements of c4c are as follows: expert advice providing input on study design and/or paediatric development programmes (including patient involvement activities); a network of sites following harmonised procedures coordinated by National Hubs and a single point of contact for Europe; a facility for education and training for sites and trial teams; and support for managing data used by the network and a common paediatric data dictionary. c4c does not sponsor trials. c4c is taking a phased approach with careful piloting through industry and non-industry studies intended to demonstrate the viability of the network (proof-of-viability studies). c4c uses a co-design approach involving industry and academics within a clearly defined scope. A sustainable, successor organization open to all potential service users will be open for business before the end of IMI2 funding in 2024.

Fleshing out the data: when epidemiological researchers engage with patients and carers. Learning lessons from a patient involvement activity

Patient and public involvement and engagement has become an essential element of health research, ensuring aims and outputs are worthwhile and relevant. However, research involving secondary data analyses does not present immediately obvious ways to involve patients and the public. Innovative approaches to ensure their involvement is meaningful and effective are required.The Cancer Survival Group cohosted a full-day meeting with the National Cancer Research Institute Consumer Forum—a group of patients and carers. This included the Forum’s ‘Dragons’ Den’: a small-group session in which their members provided insight, advice and ideas on current or planned research in the Cancer Survival Group.We investigated this activity as an example of effective patient involvement, with the aim of developing broad recommendations to improve epidemiological/quantitative research by involving patients and carers as directly as possible.In addition to quantitative data captured through evaluation forms completed after the event, we used semistructured interviews of a sample of participants to evaluate the effectiveness of the session and to learn lessons. The interviews were analysed to identify broad or recurrent themes and recommendations.Feedback was overwhelmingly positive, and some impacts on the research projects were identified. Interviewees commented on overall expectations and experiences, as well as specifics of room layout, timing of the session, composition of groups, effectiveness of the facilitation and content of discussions.We present a summary of our findings as a guide for other researchers, including recommendations for improvement gleaned from the interviews. The value to researchers of hosting and participating in such activities was clear. We developed recommendations that should help to improve future events for ourselves and for others who wish to conduct similar activities, which in turn may lead to more concrete benefits for research and patients.

OP30 From Framework To Action: Implementing Patient Engagement

Introduction:This session will share lessons learned from implementing a comprehensive patient and public engagement framework (developed by winners of the 2017 Egon Jonsson Award) in one government agency's health technology assessment (HTA) process. The presentation will share strategic and operational considerations for successful implementation, and the early effects of patient involvement activities on the agency's HTA recommendations.Methods:This presentation used a case study approach to understand the application of the framework described above.Results:The comprehensive framework by Abelson and colleagues describes many different public and patient engagement activities that could be conducted at each stage of an HTA process. Health Quality Ontario has chosen to focus on engaging patients to: prioritize topics; develop an additional evidence stream on patient preferences and values; serve on a committee that reviews the HTA, deliberates, and makes recommendations; and provide feedback on draft recommendations. Strategic considerations for these decisions include: aligning engagement activities to an evidence-focused organizational culture, and investing in engagement activities earlier in the HTA process to allow for sufficient consideration of the patient voice in developing recommendations. These activities have impacted the agency's organizational culture, and evidence suggests they have also influenced recommendations for what should be publicly funded. Patient engagement activities have also led to increased feedback from the public and patients for some HTAs and the associated draft recommendations.Conclusions:Public agencies must make strategic decisions about how and when to invest scarce resources in patient and public engagement. Investing in direct patient engagement as an additional stream of evidence and supporting the involvement of health system users in decision-making has had a significant impact on HTA deliberations and recommendations. For some HTAs, these activities have facilitated greater public engagement as well.

Public understanding of, and attitudes towards, data linkage in research

ABSTRACTObjectivesThere is an ongoing need to involve and inform the public about data linkage research. Projects at the South East Wales Trials Unit (SEWTU) and Division of Population Medicine, Cardiff University have focused on participant and public understanding of, and attitudes towards the use of routine/linked data for research purposes.
 ApproachHealthWise Wales is a Welsh national cohort using prospectively collected data linked with NHS records. Face-to-face and online focus groups were conducted to explore the barriers and facilitators to signing up to this project as well as discussing the best way to communicate the technical details of the project. MINIMAL PhD conducted a focus group with care-experienced young people to gather attitudes towards the collection and linkage of child maltreatment data. The Public and Patient Involvement activities of the Building Blocks 2-6 Study included meetings with a young mothers group utilising their skills as advisors on communicating data linkage issues with study participants. These projects have been undertaken independently however comprise the same underlying questions – Do the public understand why routine & linked data is used for research? Will this be a barrier to participating? How can we communicate study design to ensure participants are fully informed? This presentation will summarise the similarities and contrasting attitudes and beliefs emerging from these projects.
 ResultsWe have identified similar emerging themes from both the HealthWise Wales focus groups and MINIMAL PhD focus groups. Participants found it challenging to understand the methodology of data linkage and this acted as a barrier to taking part in data linkage projects. Once participants felt fully informed of the method, their concerns around data safety and confidentiality were reduced. Participants required assurances that their data were safe, that they could not be identified, and that researchers can be trusted to access these data before considering the research project in discussion. Participants also discussed the collection of sensitive data from various sources through data linkage, consent issues, and the balance between research risk/benefit for the MINIMAL PhD focus group.
 ConclusionThese qualitative studies will contribute to knowledge of how to better inform members of the public about routine / linked data, as it is clear than there remains a lack of understanding of the research conducted in this area, and the importance for researchers to utilise these data. Researchers need to get the communication right in order to be successful at recruiting and retaining participants.

Involving Patients in Research: Considering Good Practice

Increasingly, patients and members of the public are involved in the design, conduct and dissemination of research. INVOLVE, the UK’s national body for patient and public involvement, usefully defines this sort of involvement as: ‘research being carried out “with” or “by” members of the public rather than “to”, “about” or “for” them’ (INVOLVE, 2012). At the Musculoskeletal Research Unit in Bristol, we are often asked about our patient involvement work. In light of the questions that we are asked, this editorial highlights some current practice and guidance. We also reflect on the impact of our patient involvement activity and hope that this serves as a useful introduction and points interested readers to further reading.

Qualitative Approaches to Understanding Patient Preferences

Achieving patient-centered care depends on a thorough understanding of patient preferences at all stages of their journeys through healthcare. Qualitative research methods provide the means to systematically collect and analyze these preferences. Qualitative approaches to research are diverse in character, but many such approaches have a long history and strong disciplinary roots. Despite variation, most qualitative approaches work inductively from the 'ground up', and seek to build knowledge and understanding rather than test hypotheses. Their use to explore patient pathways through care has offered insight into reasons why people become patients in the first instance, their preferences for treatment options and degree of involvement in decisions, and their preferences for healthcare delivery. Qualitative approaches are sometimes used alongside 'quantitative' in mixed methods designs, requiring solid expertise and resourcing. Expertise is also crucial in the assessment of quality in qualitative research, and efforts to develop checklists to assess quality are challenged by evidence about the importance of expertise-based judgments. Recent developments in health research include an upsurge in patient involvement activities in design of research and healthcare services; these may seem similar to qualitative research, but are in fact very different. While an important part of the research landscape, patient involvement activities are not intended to provide robust research-based evidence about patients' preferences or experiences. There is pressing need to bridge the gap between qualitative research evidence and patient involvement in the design of research and services. Participatory research methods that harness qualitative approaches may be a way to achieve this.