Patient representatives: Crucial members of health-care working groups facing an uncertain role and conflicting expectations. A qualitative study.

BACKGROUND: Patient representatives (PRs) have been involved for decades in health-care development, and their participation is increasingly sought in health-care working groups (HCWGs) on every level. However, information on how the role could be further developed and teamwork improved remains sparse. OBJECTIVE: To explore the role of patient representatives in clinical practice guideline (CPG) monitoring groups, to describe their contributions and identify possibilities of improvement. DESIGN: Qualitative design using semi-structured interviews analysed by content analysis. SETTING AND PARTICIPANTS: Interviews were conducted with 11 PRs, 13 registered nurses, and 9 physicians, all members of national committees monitoring CPGs for cancer in Sweden. RESULTS: Most participants considered the PR role important but mentioned several problems. PRs' contributions were hampered by uncertainties about their role, the low expectations of other group members and their sense that their contributions were often disregarded. Some professionals questioned whether PRs were truly representative and said some topics could not be discussed with PRs present. CONCLUSION: This study highlights the fundamental problems that remain to be solved despite the long involvement of PRs in HCWGs. Even though the PR role and teamwork differed between the groups, most PRs need to be empowered to be actively involved in the teamwork and have their engagement and knowledge fully utilized. Enhancing teamwork through clarifying roles and expectations could lead to more inclusive and equal teams able to work more effectively towards the goal of improving health care. PATIENT OR PUBLIC CONTRIBUTION: PRs were information givers in data collection.

European Standards of Care for Newborn Health-A project protocol.

AIM: Among children who receive hospital care, preterm infants are Europe's largest group, whose numbers are continually increasing. Currently, no pan-European standards of care for preterm or critically ill infants are available, except for a few specific topics, and practices vary widely in different regions. METHODS: The European Foundation for the Care of Newborn Infants (EFCNI) has initiated a transdisciplinary collaboration project to provide agreed standards for high-quality perinatal and neonatal care, whose implementation will ensure fairer and more equitable care across Europe. This will improve care for these vulnerable infants and their families, ameliorate the long-term conditions found in preterm and critically ill infants and enhance the quality of family life of affected families. More than 220 experts-healthcare professionals, patient representatives and other relevant stakeholders-have come together for the first time to develop a broad reference guidance in neonatology and associated fields. RESULTS: Ninety-six standards on 11 overarching topic areas were developed and endorsed. CONCLUSION: This reference framework serves as a basis for the development of binding national standards for high-quality care. A robust translation and implementation strategy is facilitated, with the goal of improved health outcomes following preterm birth all around Europe.

Financial relationships between patient and consumer representatives and the health industry: A systematic review.

BACKGROUND: Patients and consumers are increasingly engaged in health policymaking, research and drug regulation. Having financial relationships with the health industry creates situations of conflicts of interest (COI) and might compromise their meaningful and unbiased participation. OBJECTIVE: To synthesize available evidence on the financial relationships between the health industry and patient and consumer representatives and their organizations. METHODS: We systematically searched MEDLINE and EMBASE. We selected studies and abstracted data in duplicate and independently. We reported on outcomes related to financial relationships of individuals with, and/or funding of organizations by the health industry. RESULTS: We identified a total of 14 510 unique citations, of which 24 reports of 23 studies were eligible. Three studies (13%) addressed the financial relationship of patient and consumer representatives with the health industry. Of these, two examined the proportion of public speakers in drug regulatory processes who have financial relationships; the proportions in the two studies were 25% and 19% respectively. Twenty studies (87%) addressed funding of patient and consumer organizations. The median proportion of organizations that reported funding from the health industry was 62% (IQR: 34%-69%) in questionnaire surveys, and 75% (IQR: 58%-85%) in surveys of their websites. Among organizations for which there was evidence of industry funding, a median proportion of 29% (IQR: 27%-44%) acknowledged on their websites receiving that funding. CONCLUSION: Financial relationships between the health industry and patient and consumer representatives and their organizations are common and may not be disclosed. Stricter regulation on disclosure and management is needed.

My life with pulmonary arterial hypertension: a patient perspective.

In recent years, there has been an increase in therapeutic options and treatment strategies for pulmonary arterial hypertension (PAH). However, patients still report delays in receiving a diagnosis, which is a significant burden associated with the disease, and which shows a general lack of disease awareness. This review has been written by two PAH patients to describe the patient experience and explore the ways in which patients are increasingly being given a voice in developing approaches to treatment. As patients with PAH are living longer, it is important that they work with healthcare professionals to develop treatment strategies that improve and maintain quality of life. Healthcare professionals should consider a holistic approach to disease management, including dietary recommendations, individually adapted exercise, and options for counselling where available, alongside therapeutic treatments. The experiences of patients with PAH are important not just for individual patient treatment but should also be considered in clinical trial design and guideline development. Patient representatives and patient associations can play an influential role in improving the treatment and management of PAH. In this review, we use our experiences as patient representatives to describe the current situation of patients with PAH from first experiencing symptoms to receiving treatment, using two patient cases as examples. We also discuss the role of patient advocacy in improving PAH care and future roles for patient associations and patient representatives in the design of clinical trials and development of new treatment guidelines.

Patient representatives' contributions to the benefit-risk assessment tasks of the European Medicines Agency scientific committees.

In the European Medicines Agency (EMA), the involvement of patients has been increasingly recognized as valuable and necessary. Specifically in scientific committees, patients through patient representatives are actively involved in deliberations and decision making processes. These scientific committees are meant to ensure that licensed medicines have a positive benefit-risk ratio in favour of the patients and users. To investigate what the contributions are of patient representatives in benefit-risk assessment, we interviewed 15 scientific committee members, 10 of whom are/were EU-state regulatory representatives and five are/were patient representatives. We asked the participants questions related to the benefit-risk assessment tasks of their committees, the connection between patient representatives and the patient perspective, and the contribution of patient representatives in the various benefit-risk assessments tasks. We found that the contribution of patient representatives benefit-risk assessment may be a variable of the benefits and the risks involved in the drug such that the necessity of their contribution is strongly felt when both benefits and risks are high, when benefits are almost equal or are equal to risks and when both benefits and risks are low. In terms of the various benefit-risk tasks, patient representatives contribute to benefit-risk analysis by providing criteria that help define the benefit-risk picture. In benefit-risk evaluation, patient representatives aid in providing a specific basis for the values and weights given to specific benefits and risks and in decision making, they provide what may be a crucial patient perspective in terms of the acceptability of risks. Hence, patient representatives provide a specific expertise in these scientific committees.

End-of-life decisions for people with intellectual disabilities, an interview study with patient representatives.

BACKGROUND: Not much is known about the process of end-of-life decision-making for people with intellectual disabilities. AIM: To clarify the process of end-of-life decision-making for people with intellectual disabilities from the perspective of patient representatives. DESIGN: A qualitative study based on semi-structured interviews, recorded digitally and transcribed verbatim. Data were analysed using Grounded Theory procedures. PARTICIPANTS: We interviewed 16 patient representatives after the deaths of 10 people with intellectual disabilities in the Netherlands. RESULTS: The core category 'Deciding for someone else' describes the context in which patient representatives took end-of-life decisions. The patient representatives felt highly responsible for the outcomes. They had not involved the patients in the end-of-life decision-making process, nor any professionals other than the doctor. The categories of 'Motives' and 'Support' were connected to the core category of 'Deciding for someone else'. 'Motives' refers to the patient representatives' ideas about quality of life, prevention from suffering, patients who cannot understand the burden of interventions and emotional reasons reported by patient representatives. 'Support' refers to the support that patient representatives wanted the doctors to give to them in the decision-making process. CONCLUSIONS: From the perspective of the patient representatives, the process of end-of-life decision-making can be improved by ensuring clear roles and an explicit description of the tasks and responsibilities of all participants. Regular discussion between everyone involved including people with intellectual disabilities themselves can improve knowledge about each other's motives for end-of-decisions and can clarify expectations towards each other.

Patient engagement in pharmaceutical development: Where are we? - Report from a symposium.

In recent years, the term "patient engagement" has found its way into healthcare and specifically into the field of drug development. To better understand the actual status of "patient engagement" in drug development, a symposium was organized by the Drug Research Academy of the University of Copenhagen (Denmark) on November 16, 2022. The symposium brought together experts from regulatory authorities, industry, academia and patients to share their views and experience of and with patient engagement in drug product development. The symposium led to intensive discussions among the speakers and the audience, confirming that viewpoints and experiences of the different stakeholder provide important input into the promoting patient engagement along the entire drug development life cycle.

How doctors manage conflicts with families of critically ill patients during conversations about end-of-life decisions in neonatal, pediatric, and adult intensive care.

PURPOSE: Intensive care is a stressful environment in which team-family conflicts commonly occur. If managed poorly, conflicts can have negative effects on all parties involved. Previous studies mainly investigated these conflicts and their management in a retrospective way. This study aimed to prospectively explore team-family conflicts, including its main topics, complicating factors, doctors' conflict management strategies and the effect of these strategies. METHODS: Conversations between doctors in the neonatal, pediatric, and adult intensive care unit of a large university-based hospital and families of critically ill patients were audio-recorded from the moment doubts arose whether treatment was still in patients' best interest. Transcripts were coded and analyzed using a qualitative deductive approach. RESULTS: Team-family conflicts occurred in 29 out of 101 conversations (29%) concerning 20 out of 36 patients (56%). Conflicts mostly concerned more than one topic. We identified four complicating context- and/or family-related factors: diagnostic and prognostic uncertainty, families' strong negative emotions, limited health literacy, and burden of responsibility. Doctors used four overarching strategies to manage conflicts, namely content-oriented, process-oriented, moral and empathic strategies. Doctors mostly used content-oriented strategies, independent of the intensive care setting. They were able to effectively address conflicts in most conversations. Yet, if they did not acknowledge families' cues indicating the existence of one or more complicating factors, conflicts were likely to linger on during the conversation. CONCLUSION: This study underlines the importance of doctors tailoring their communication strategies to the concrete conflict topic(s) and to the context- and family-related factors which complicate a specific conflict.

The Role of EUPATI CH in Promoting Patient Involvement in Clinical Research: A Multi-Stakeholder Research Project.

Background: The European Patients' Academy on Therapeutic Innovation Switzerland (EUPATI CH) was established as an association in 2016 with the mission to improve patient empowerment in Switzerland, raise public awareness of EUPATI's education material, and foster multi-stakeholder partnerships in order to promote public involvement in all aspects of medicines research and development (R&D). In order to achieve its goal of improving patient involvement (PI) in all processes of medicines R&D in Switzerland and to obtain guidance and recommendations for future activities, EUPATI CH initiated a multi-stakeholder survey on PI experiences, hurdles, and best practices. The survey enabled EUPATI CH to obtain and analyze the views of various stakeholders and shape its workplan. Methods: Data collection occurred between January and July 2019 using a survey and semi-structured interviews with individual stakeholders from different groups. The online survey responses were analyzed using quantitative methods and the interviews were analyzed using qualitative methods. Results: The online survey was completed by 55 respondents (10%), and the semi-structured interviews were conducted with 14 stakeholders. Respondents to the online survey were patient representatives (45%), researchers from academia (25%), individuals from the pharmaceutical industry (9%), healthcare professionals (23%), and representatives from government agencies (6%). Some respondents were also members of EUPATI CH. Thirty-eight percent of respondents consider PI in Switzerland to be limited or absent. They identified the main barriers to PI as, first and foremost, a lack of funds and human resources (65%), followed by a lack of information and a lack of education on how to become a patient advocate (21%), a lack of collaboration with other stakeholders (16%), and a lack of adequate resources. Respondents' expectations of EUPATI CH's role in supporting PI were to provide education for active PI and improve networking and collaboration among stakeholders. Conclusions: EUPATI CH's multi-stakeholder research identified some of the difficulties in promoting PI in medicines R&D in Switzerland, in particular the complex collaboration among stakeholders and a lack of funds, human resources, and knowledge. To respond to these difficulties, EUPATI CH has begun preparing a basic training course for patients that is adapted to Switzerland.

Integrating Patient-Centred Research in the Canadian Cancer Trials Group.

The inclusion of patients as partners in research is a key link in the delivery of patient-centred care in healthcare systems. Despite genuine intentions to engage patients in authentic partnerships, efforts can result in tokenism and benefits of engagement are missed. Understanding how patient engagement provides value along the research to patient-care continuum and how to best engage patients as partners are key. This document describes the method taken by the Canadian Cancer Trials Group (CCTG) to implement meaningful patient centricity and engagement and the benefits realized. Originally, Patient Representatives were recruited and assigned to CCTG Committees. Lacking guidance, the role was one of a passive meeting attendee. A gap analysis identified a need for clarity in expectations, understanding of the linkage to CCTG strategic objectives, and supporting tools and training. A plan was developed and successfully implemented in three phases, each phase building on the previous, the level of patient engagement simultaneously changing from "Inform" to "Involve" to "Collaborate" on the International Association for Public Participation (IAP2) scale. Results include significant contributions to increased patient accrual in CCTG trials, to increased CCTG grant funding, as well as recognition and adoption of these practices within Canada and internationally.

The Launch of the European Patients' Academy on Therapeutic Innovation in the Netherlands: A Qualitative Multi-Stakeholder Analysis.

Background: Involving patients' representatives in the research and development of medicinal products (medicines R&D) leads to better medical treatment. In 2014, the European Patients' Academy on Therapeutic Innovation (EUPATI) was started with the goal of increasing the capacity and capabilities of patient representatives in this field. To make this academy more accessible and applicable for the Netherlands, a Dutch version was launched in September 2019. To explore the options for a durable infrastructure for organizing the Dutch EUPATI course, a multi-stakeholder qualitative study was done. The views of various stakeholders from pharmaceutical industry, governmental organizations, patient organizations, and the academic world were examined about the benefits and challenges of this course for patient involvement in medicines R&D. Methods: From April to June 2019, 10 semi-structured interviews were completed, each with two representatives of all stakeholders involved. In addition, individual Dutch graduates of the European EUPATI (EUPATI fellows) were consulted via an e-mail questionnaire. Using a directed content analysis based on the Business Canvas Model, the transcribed interviews were coded, analyzed, and final attributes consolidated. Results: The semi-structured interviews and completed questionnaires explored how the stakeholders are aiming to assist patient involvement in medicines R&D through the Dutch EUPATI course. The building blocks of the Business Canvas Model were described with concrete attributes for making the business case. Stakeholders stated that the Dutch EUPATI course was an incentive for patient involvement in medicines development, for patient-oriented research and outcomes, for the availability of patient representatives (expert ones in particular), and for the content and representation quality of patient representatives. The key values for collaborating in the network as mentioned by the stakeholders were neutrality, patients' interests, equality, independence, shared objectives, long-term commitment, transparency, understanding, trust, and respect. Conclusions: Patient involvement in medicines R&D is evolving and the demand for qualified patient representatives is growing. Dutch stakeholders confirmed the added value of the patients' academy and expressed their willingness to contribute. Important values and conditions for long term collaboration were formulated.

Improving Screening Programmes for Sickle Cell Disorders and Other Haemoglobinopathies in Europe: The Role of Patient Organisations.

This discussion paper has been written to show the unique contribution and added value that Patient Organisations can give to the development and improvement of newborn screening programmes for sickle cell disorder (SCD) and other haemoglobinopathies in Europe. As an example, the action of the Sickle Cell Society (SCS) in partnership with statutory organisations in the U.K., such as the National Health Service (NHS) Sickle Cell and Thalassaemia Screening Programme (NHS SCT SP), will be described.

How do women with lupus manage fatigue? A focus group study.

OBJECTIVE: Half of patients with systemic lupus erythematosus (SLE) consider fatigue to be the most disabling disease symptom. To develop and promote strategies to prevent and control fatigue, this study aimed to describe how women with SLE manage the experience of fatigue. METHODS: Four focus groups were conducted with 27 women with SLE, and data were analyzed by means of framework analysis. Two patient representatives with SLE were part of the investigator team. RESULTS: The analysis revealed three main themes (i.e., learning how to be open about fatigue, learning to listen to the body, and learning to accept fatigue) and six sub-themes (i.e., the search for recognition, legitimization, planning and prioritizing, the body's limits and self-indulgence, adjusting life to comply with resources, and acceptance of dependence). CONCLUSION: Fatigue is the controlling element in everyday life of women with SLE. Patients try to integrate fatigue into their everyday lives by attempting to control it and meet the challenges of structure and planning. This study indicates a need for clinicians to acknowledge patients' fatigue, including supporting patients' own resources, offering information, and conversation about fatigue, as well as involving patients' relatives.

Stakeholders' views on granting prescribing authority to pharmacists in Nigeria: a qualitative study.

Background In Nigeria, only medical doctors, dentists and some nurses in primary care facilities have the legal right to prescribe medicines to patients. Patients' access to prescription medicines can be seriously affected by the shortage of prescribers leading to longer waiting times in hospitals. Objective This research was carried out to investigate stakeholders' views on granting prescribing authority to pharmacists in Nigeria. Setting The study was conducted in Nigeria. Methods Qualitative, semi-structured interviews were conducted with 43 Nigerian stakeholders including policymakers, pharmacists, doctors and patient group representatives. Transcribed interviews were entered into the QSR NVivo 10 software and analysed using a thematic approach. Main outcome measure Stakeholders' perception on the granting of prescribing authority to pharmacists in Nigeria. Results Three major themes emerged from the interviews: (1) prescribing as a logical role for pharmacists, (2) pharmacist prescribing- an opportunity or a threat and (3) the potential barriers to pharmacist prescribing. Many non-medical stakeholders including pharmacists and patient group representatives supported an extended role for pharmacists in prescribing while the majority of medical doctors including those in policy making were reluctant to do so. Generally, all stakeholders perceived that pharmacist prescribing represents an opportunity to increase patients' access to medicines, reduce doctors' workload and promote the utilisation of pharmacists' skills. However, many stakeholders including pharmacists and doctors commonly identified pharmacists' inadequate skills in diagnosis, medical resistance and shortage of pharmacists as potential barriers to the introduction of pharmacist prescribing in Nigeria. Conclusion The present study showed a split of opinion between participants who were medical doctors and those who were non-doctors in their support for pharmacist prescribing. However, all stakeholders acknowledged the potential of pharmacist prescribing to increase patients' access to medicines in Nigeria.