Process Of Patient Involvement Research Articles

Patient Involvement in the Design of an Innovative Clinical Study to Compare the Palatability of Anti-Hyperkalemia Medications.

The inclusion of patient representatives as study consultants brings diverse perspectives, insights, and experiences to clinical trial design and execution, and their role in the clinical trial development process is being increasingly recognized and valued. The APPETIZE study evaluated the palatability of, and preference for, three potassium binders for treating hyperkalemia in patients with chronic kidney disease. A core aspect of the development of this study was the inclusion of a patient representative during the design stage. Here, I describe the process of patient involvement in the APPETIZE study design (ClinicalTrials.gov Identifier: NCT04566653), the resultant positive impacts, and key learnings. A patient with chronic kidney disease was invited to be a member of the APPETIZE trial design team. This patient representative attended study team meetings and provided invaluable input into protocol development, questionnaire selection, design of patient information sheets and consent forms, and primary manuscript structure. These critical insights resulted in an enhanced trial design and generation of high-quality, patient-relevant data. APPETIZE provides an excellent example of a patient preference study that relied on input from multiple stakeholder groups, including, most notably, the patients themselves. This approach may serve as a model for early and deep patient engagement in the design and interpretation of clinical trials.

PP11 Patient Involvement In Drug Evaluations To Inform Funding Decisions: A Singapore Case Study

IntroductionPatient involvement has become increasingly integral to health technology assessment (HTA) processes globally due to greater recognition of the important contribution patients make to address uncertainties in the scientific evidence base and interpret results for real-world implementation. To align with best practices and encourage meaningful patient input in HTAs in Singapore, patient involvement processes were established by the Agency for Care Effectiveness (ACE) in 2021. This presentation discusses how patient groups were identified in Singapore and describes the new patient involvement processes.MethodsIn the absence of a centralized database, a stakeholder mapping exercise was undertaken in 2021 to identify all relevant patient and volunteer groups in Singapore. A comprehensive search of the Singapore Charity Portal, hospital websites, standard search engines and social media platforms was conducted.Identified groups were screened in line with specific inclusion criteria and contacted via email and cold calling to find out more about their remits. Plain English resources, targeted training materials and a process guide to encourage patient involvement in ACE’s work were co-developed with local patient organizations by drawing upon best practices from overseas HTA agencies contextualized to local patients’ needs. Supporting resources and processes were revised in 2022 based on ACE’s experience receiving inputs from patients and caregivers to inform drug HTAs.ResultsOne hundred and six patient groups covering 20 conditions were identified including registered organizations and informal support groups. In the first half of 2022, ACE received responses from 82 patients from ten patient organizations to inform seven drug HTAs for cancer, diabetes, HIV, and other conditions in line with the new patient involvement processes. Patient organizations viewed the opportunity to submit testimonials of their lived experience with different conditions as a meaningful and important activity for their members.ConclusionsPatient involvement processes have improved the legitimacy and acceptance of ACE’s work and will be continuously revised to ensure that they remain relevant and meet patients’ expectations and needs.

Patient and citizen participation at the organizational level in health technology assessment: an exploratory study in five jurisdictions.

While patient participation in individual health technology assessments (HTAs) has been frequently described in the literature, patient and citizen participation at the organizational level is less described and may be less understood and practiced in HTA bodies. We aimed to better understand its use by describing current practice. To elicit descriptive case studies and insights we conducted semi-structured interviews and open-ended questionnaires with HTA body staff and patients and citizens participating at the organizational level in Belgium, France, Quebec, Scotland, and Wales. We identified examples of organizational participation in managerial aspects: governance, defining patient involvement processes, evaluation processes and methods, and capacity building. Mechanisms included consultation, collaboration, and membership of standing (permanent) groups. These were sometimes combined. Participants were usually from umbrella patient organizations and patient associations, as well as individual patients and citizens. Although the concept, participation at the organizational level, is not well-established, we observed a trend toward growth in each jurisdiction. Some goals were shared for this participation, but HTA bodies focused more on instrumental goals, especially improving participation in HTAs, while patients and citizens were more likely to offer democratic and developmental goals beyond improving participation processes. Our findings provide rationales for organizational-level participation from the perspectives of HTA bodies and patients. The case studies provide insights into how to involve participants and who may be seen as legitimate participants. These findings may be useful to HTA bodies, the patient sector, and communities when devising an organizational-level participation framework.

Interdisciplinarity and Patient Engagement: New Representations of Cardiovascular Anatomy.

This article presents and discusses the genesis, making and public presentation of two artworks by British artist Sofie Layton, namely Blueprints and The Bud, which explore the anatomy of the heart infusing it with experiential and narrative elements. Artist-led workshops with a range of audiences (cardiac patients, medical staff, medical students, creative professionals, and patient relatives) led to explore narratives and imagery that, in turn, was re-presented in artworks exploring the complexity of the cardiovascular system. While positioning themselves in a long tradition of artistic representations of the heart, often purely anatomical or autobiographical, these artworks stem from a process of patient involvement and participation. Integral to the pieces is an interdisciplinary approach, which is central to arts-and-health collaborations. At a time in which the role of the arts in improving health and wellbeing is increasingly recognised and supported by evidence, these artworks offer an opportunity to reflect not only on ways of representing cardiovascular anatomy, but also on its experiential value and on the important of patient engagement and involvement.

"ENGAGING WITH THE BENEFICIARIES IN REFORMING HEALTH CARE. A CASE STUDY OF PATIENT INVOLVEMENT IN THE REFORM OF PSYCHIATRIC CARE IN THE CZECH REPUBLIC"

"The involvement of patients and their families in healthcare policymaking has been a general trend in recent years. This tendency can be observed also in the process of the current reform of psychiatric care in the Czech Republic, which should gradually shift the focus of psychiatric care from large facilities to community care. Organizations representing patients and their families are among the key stakeholders in this reform. The present study analyses semi-structured in-depth interviews and documents with the objective to map and evaluate the process of patient involvement in the reform from its launch to its implementation in 2012-2019. The study identifies the major barriers to patient involvement – on the part of the patients and their organizations, professionals (healthcare professionals, care providers, administration, policymakers), as well as the whole society. It becomes clear that the reform encourages patient involvement, with a palpable shift from consultation to involvement. Still, there are many obstacles to patient involvement in the Czech Republic: the mental state, social and economic situation of the patients, paternalism on the part of care providers, tokenism or stigmatization of mentally ill people."

Scottish Health Technologies Group: enhancing patient engagement.

The Scottish Health Technologies Group (SHTG) provides evidence support and advice to the National Health Service in Scotland on the use of new and existing health technologies, which, although not medicines, are likely to have significant implications for people's care. The purpose of this paper is to highlight the developments that have taken place in the SHTG's patient involvement processes in the years 2017 to 2019, focusing primarily on specific engagement with patient organizations and considering how the new approaches have been received by stakeholders. Feedback from patient organizations that participated in the SHTG submission process, alongside SHTG committee members' views on patient organizations contributions, was gathered primarily via online questionnaires. The number of times that patient organizations were invited and accepted the opportunity to peer-review SHTG advice statements prior to and after the employment of a Public Involvement Advisor (PIA) was analyzed. Completed questionnaires (n = 4) from three case study examples showed high patient organization satisfaction with their experience of the SHTG process. The feedback from SHTG committee members that was gathered indicated that patient organization participation was generally well received. The number of peer reviews from patient organizations for SHTG advice statements in 2018-2019 doubled to 86 percent of the total advice statements (n = 22), compared with 43 percent (n = 14) in 2016-2017. Significant progress has been made toward improving the SHTG's patient involvement processes. A dedicated PIA post within the SHTG has allowed for a more tailored support to patient organizations and has encouraged their increased participation in SHTG processes.

Do Physicians' Attitudes towards Patient-Centered Communication Promote Physicians' Intention and Behavior of Involving Patients in Medical Decisions?

Promoting patient-centered communication among physicians is one core strategy for improving physician–patient relationships and patient outcomes. Our study aims to understand the physicians’ attitudes towards patient-centered communication and its effects on physicians’ intention and behavior of involving patients in medical decisions in primary care in China. One cross-sectional study was conducted in primary facilities in Hubei province, China, from December 2019 to January 2020, where physicians’ attitudes towards patient-centered communication were measured by the Chinese-revised patient–practitioner orientation scale. Multilevel ordinal logistic regression was conducted for estimating the effects of physicians’ attitudes on their intention and behavior of patient involvement in medical decisions. Six hundred and seventeen physicians were investigated for the main study. Physicians had a medium score of patient-centered communication (3.78, SD = 0.56), with relatively high caring subscale score (4.59, SD = 0.64), and low sharing subscale score (3.09, SD = 0.75). After controlling physicians’ covariates, physicians’ attitudes towards patient-centered communication was significantly associated with a higher intention of involving patients in medical decisions (OR > 1, p = 0.020). Physicians’ positive attitudes towards patient-centered communication affected their intention of involving patients in medical decisions, which implies the importance of taking the physicians’ attitudes into account for the accomplishment of patient involvement processes.

VP37 Patient Involvement In EUnetHTA Assessments (Non-Pharma Technologies)

IntroductionPatients can provide valuable experience on living with diseases, health-related quality of life, various therapies and relevant outcomes. Their input and perspectives can be helpful in complementing health technology assessment (HTA) processes. The European Network for HTA (EUnetHTA), funded by the European Commission, aims to further advance and standardise patient involvement processes in order to add to the quality and applicability of HTAs and to allow capability building.MethodsDifferent methods for patient involvement in HTAs on non-pharmaceutical technologies were tested: Patient input templates (open questions sent to relevant patient organizations, or published on EUnetHTA website); scoping meeting with patients/patient representatives; one-on-one conversation and group conversation. Applied methods depended on the scope of the HTA and other factors like timelines of HTAs and burden of disease for patients.ResultsPatients were included in eight of sixteen HTAs on non-pharmaceutical technologies. Applied methods were: group conversation (n = 2), scoping meeting (n = 1), patient input templates (n = 4), one-on-one conversation (n = 2,) and other approach (i.e. written feedback on scope n= 2). In some HTAs more than one method was used. Main reasons for not including patients were inability to identify suitable patients or tight timelines. Patients' feedback on health-related quality of life and outcome measures proved most useful in the scoping phase.ConclusionsThe different approaches were useful for complementing HTA processes. Those need to be further tested and evaluated in order to formulate deeper understanding about the impact of patient involvement on HTA. Additionally, feedback from patients that were actively involved in the HTAs should be collected to further improve the involvement methods that should serve as basis for future recommendations post 2020.

OP78 Patient Involvement In European Health Technology Assessment Focus Group With Cardiac Patients

INTRODUCTION:Involving patients in defining the scope of health technology assessments is recognized as a valuable strategy that ensures that patient-relevant outcomes are considered.The aim of this project was to pilot the focus group approach with cardiac patients in a European rapid assessment on the wearable cardioverter defibrillator, to improve involvement processes, to identify neglected outcomes, and to explore the potential of this methodology for eliciting the patients views on their disease and the wearable cardioverter defibrillator therapy.METHODS:An e-mail was sent to members of the nine regional associations of the Austrian Organization for Heart and Lung Transplant Patients to identify eligible participants. Guiding questions for the discussion were developed based upon a hand search of patient involvement initiatives and a review of appropriate literature. The 4-hour meeting was moderated by a patient support expert and recorded upon approval of participants. The anonymized transcript was analyzed using framework analysis.RESULTS:Ten eligible patients responded, of which five men, aged between 55 and 73 years (mean 65 years) from Austria and Germany, were able to participate. All respondents experienced heart transplantation, and four had received an implantable cardioverter defibrillator before.Participants reported that experiencing a sense of security was crucial to them and that they expected to do sports and live a life with few limitations, despite receiving a therapy. A wearable cardioverter defibrillator was hence not considered a long-term solution due to expected restrictions in living a ‘normal’ life.Challenges included the identification of participants representative of this patient group and the complexity of patient histories.CONCLUSIONS:The focus group approach proved useful in the wearable cardioverter defibrillator assessment. Gathered results informed the inclusion of outcomes relevant to the target group and revealed patients views on health-related quality of life. Lessons learned guide us in further improving patient involvement processes within the European Network for HTA (EUnetHTA) project.

The Regina Elena National Cancer Institute process of accreditation according to the standards of the Organisation of European Cancer Institutes.

The accreditation process is, on the one hand, a tool used to homogenize procedures, rendering comparable and standardized processes of care, and on the other, a methodology employed to develop a culture of quality improvement. Although not yet proven by evidence-based studies that health outcomes improve as a result of an accreditation to excellence, it is undeniable that better control of healthcare processes results in better quality and safety of diagnostic and therapeutic pathways. The Regina Elena National Cancer Institute underwent the accreditation process in accordance with the standards criteria set by the Organisation of European Cancer Institutes (OECI), and it has recently completed the process, acquiring its designation as a Comprehensive Cancer Center (CCC). This was an invaluable opportunity for the Regina Elena Institute to create a more cohesive environment, to widely establish a culture of quality, to implement an institutional information system, and to accelerate the process of patient involvement in strategic decisions. The steps of the process allowed us to evaluate the performance and the organization of the institute and put amendments in place designed to be adopted through 26 improvement actions. These actions regarded several aspects of the institute, including quality culture, information communication technology system, care, clinical trials unit, disease management team, nursing, and patient empowerment and involvement. Each area has a timeline. We chose to present the following 3 improvement actions: clinical trial center, computerized ambulatory medical record, and centrality of patient and humanization of clinical pathway.

Power relations and contrasting conceptions of evidence in patient-involvement processes used to inform health funding decisions in Australia

We collected and analysed views of key stakeholders on the processes used to involve patient organisations in health care funding decision making in Australia. We conducted 12 semi-structured interviews with patient organisation representatives and members of Advisory Committees that provide advice to the Australian Department of Health and employ Health Technology Assessment (HTA) as an evaluation framework. Using two theoretical frameworks, we analysed structural and contextual elements pertaining to the involvement processes. The findings reported in this article relate to interviewees' perspectives on contextual elements, analysed using a Foucauldian lens. These elements include: the perspectives of marginalised voices; the diversity of views on what ought to be considered valid evidence in a HTA setting; and the relationships between stakeholders, along with how these relationships impact on involvement processes and the outcomes of those processes. The findings demonstrate that the involvement processes currently used are deemed inadequate by both patient organisation representatives and Advisory Committee members, but for different reasons connected to how different stakeholders conceptualise evidence. Advisory Committee members viewed evidence as encompassing clinical outcomes and patient preferences, whereas patient organisation representatives tended to view evidence as encompassing aspects not directly related to a disease entity, such as the social and emotional aspects of patients' experiences in living with illness. Patient organisation representatives reported interacting with other stakeholders (especially industry) to increase the influence of their conception of evidence on decision making. The use of this strategy by interviewees illustrates how power struggles occur in government decision-making processes which involve both medical expertise and patients' accounts. Such struggles, and the power differentials they reflect, need to be considered by those responsible for designing and implementing meaningful public- and patient-involvement processes.

The professional perspective on patient involvement in the development of quality indicators: a qualitative analysis using the example of chronic heart failure in the German health care setting.

PurposeThere is an international consensus that quality indicators (QIs) of health care ought to represent patient-relevant aspects. Therefore, patient involvement in the development process is essential. However, there is no methodological gold standard for involving patients in QI development. The aim of this study is to explore experts’ views on the representation of patient-relevant aspects in the QI development process using the QIs developed in the context of the German National Disease Management Guideline for Heart Failure as an example.MethodsSemi-structured, open telephone interviews were conducted with 15 German experts (patient representatives, physicians, researchers, and methodologists involved in guideline development or quality assessment). Interview themes were the relevance of the exemplary set of QIs for patients, as well as the legitimacy of, competence of, and collaboration with the patient representative who participated in the development process. Interviews were fully transcribed and content analyzed. Deductive categories derived from the research questions were supplemented by inductively formed categories during the review of the interview material.ResultsThe qualitative analysis suggests a discrepancy between the guidelines’ QIs and those relevant to patients from an expert’s point of view, such as physician-patient communication and quality of counseling. Experts reported only minor communication and cooperation problems while working together in the guideline/QI development team. Concerns existed, for example, regarding the recruitment of patient representatives for diseases without self-help organizations, the financing of patient representation, and the training of patient representatives. Only few potential strategies for improving the process of patient involvement were mentioned.ConclusionIntegrating the patients’ perspectives through the recruitment of a patient representative to participate in the development team was well established and broadly accepted. However, experts stated that the finally selected QIs represent only a small part of the patient-relevant aspects of medical care. According to the experts’ perceptions, the current processes provide a very limited scope for integrating the patients’ perspectives in a more extensive way. Supplementing the set of “conventional” QIs with additional, separately developed, “patient-side” QIs might help to include patient priorities in quality measurement.

Lay REC members: patient or public?

In practice, the role of lay members of research ethics committees (RECs) often involves checking the accessibility of written materials, checking that the practical needs of participants have been considered...

Patient involvement in mental health care: culture, communication and caution

Patient or service user involvement in mental health services (MHS) is a hallmark of the recovery approach. In this viewpoint article, we review Tambuyzer etal. paper 'Patient involvement in mental health care: One size does not fit all' in order to express our opinion of their work. We also suggest specific actions that may enhance the implementation of patient involvement in MHS. We make three main points about Tambuyzer etal. model. First, the cultural dimension of patient involvement seems underemphasized in the model. Second, the model might be improved if the increasing role of communications technology in patient involvement is taken into consideration. Third, it is important to acknowledge that the process of patient involvement is not linear, and participation is not a homogeneous experience. We suggest that the model be expanded and that further work be carried out on the implementation of patient involvement in MHS.