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Patient Involvement in the Lifecycle of Medicines According to Belgian Stakeholders: The Gap Between Theory and Practice.

ABSTRACT: Background: Patient involvement is often acknowledged as an important aspect of the lifecycle of medicines. Although different typologies exist, patient involvement has been described as the involvement of patients in decision-making regarding medicines. In view of the diversity of stakeholders and types of decisions in which patients might be involved, an in-depth understanding of these stakeholders' views toward involving patients in the lifecycle of medicines is essential. Methods: Interviews and surveys were used to gain insights into the perspectives and experiences of Belgian healthcare stakeholders. Interviews (n = 22) were conducted with academics, hospital pharmacists and representatives from health insurance funds, the Belgian reimbursement agency, pharmaceutical industry and patient organizations. Interviews underwent a framework analysis. Surveys (n = 108) were completed by hospital visitors and analyzed descriptively. Results: Despite an increasing amount of efforts to involve patients, interviewees labeled the level of actively involving patients as rather low and scattered across the different phases of the lifecycle of medicines. The main opportunities for patient involvement highlighted by interviewees were for: (i) informing early development decisions on which treatments to develop, (ii) clinical trial endpoint selection and (iii) clinical trial protocol design. However, remaining questions surrounding patient knowledge, and particularly how and which patients to involve represent important barriers toward implementing patient involvement in the lifecycle of medicines. Of survey participants, 77% indicated to be willing to participate in patient preference studies. Reasons for participating mentioned most frequently were "to improve development of treatments," because "it is important to explore and listen to patient preferences" and "to have a voice as patients". Conclusions: The barriers identified in this study hamper transitioning patient involvement from theory to practice. Bridging this gap requires addressing the identified barriers and unresolved questions surrounding the right methodology for involving patients, the "right patients" to involve and means to increase patient knowledge. In order to do so, further research should focus on assessing the value of methods that allow to indirectly capture patients' perspective both in the context of development as well as in the context of evaluation.

SUBMITTER: Janssens R

PROVIDER: S-EPMC6193089 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature

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Patient Involvement in the Lifecycle of Medicines According to Belgian Stakeholders: The Gap Between Theory and Practice.

Janssens Rosanne R van Overbeeke Eline E Verswijvel Lotte L Meeusen Lissa L Coenegrachts Carolien C Pauwels Kim K Dooms Marc M Stevens Hilde H Simoens Steven S Huys Isabelle I

Frontiers in medicine 20181011

<b>Background:</b> Patient involvement is often acknowledged as an important aspect of the lifecycle of medicines. Although different typologies exist, patient involvement has been described as the involvement of patients in decision-making regarding medicines. In view of the diversity of stakeholders and types of decisions in which patients might be involved, an in-depth understanding of these stakeholders' views toward involving patients in the lifecycle of medicines is essential. <b>Methods:< ...[more]

PMID: 30364285

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Project description:EUPATI Belgium (EUPATI.be) is an informal gathering of local partners who are interested in improving patient involvement in healthcare innovation and medicines research and development. EUPATI.be brings together various stakeholders from different areas related to healthcare including patients, academia and industry. In doing so, we create an innovative collaborative approach where actors from different backgrounds work toward improving patient involvement in medical research, and putting the patient at the center of the Belgian healthcare system. Previously, we performed in-depth interviews with a small group of stakeholders on patient involvement. Here, we elaborate on our previous findings by using a nation-wide survey to inquire into Belgian stakeholders' perception on patient involvement. To this end, an electronic survey was available in French, Dutch and English, and accessible for 11 months. Twelve questions were asked, including 11 multiple choice questions and 1 open question. The latter was thematically analyzed according to the framework method. A total of 117 responses were registered and descriptive statistics were performed. The majority of respondents could be categorized into patient, academia and industry, whereas policy makers, payers, and healthcare professionals were underrepresented. We identified several barriers that hamper patient involvement, which were sometimes more reported by specific stakeholder groups. Next, we found that various stakeholders still consider patient involvement as a passive role, i.e., medical subject in a clinical trial. Respondents also reported that the role of the various stakeholders needed more clarification; this was also confirmed by the level of trust amongst the various stakeholders. Existing and the wish for more collaboration with the various stakeholders was reported by almost all respondents. Based on this survey, we can define the potential of involving patients in the medical research and development in the Belgian landscape. Our results will help to understand and tackle the various barriers that currently hamper patient involvement, whilst highlighting the need for a collaborative landscape from the multi-stakeholder perspective.

Project description:BackgroundPatients and their families have become more active in healthcare systems and research. The value of patient involvement is particularly relevant in the area of rare diseases, where patients face delayed diagnoses and limited access to effective therapies due to the high level of uncertainty in market approval and reimbursement decisions. It has been suggested that patient involvement may help to reduce some of these uncertainties. This review explored existing and proposed roles for patients, families, and patient organizations at each stage of the lifecycle of therapies for rare diseases (i.e., orphan drug lifecycle).MethodsA scoping review was conducted using methods outlined by Arksey and O'Malley. To validate the findings from the literature and identify any additional opportunities that were missed, a consultative webinar was conducted with members of the Patient and Caregiver Liaison Group of a Canadian research network.ResultsExisting and proposed opportunities for involving patients, families, and patient organizations were reported throughout the orphan drug lifecycle and fell into 12 themes: research outside of clinical trials; clinical trials; patient reported outcomes measures; patient registries and biorepositories; education; advocacy and awareness; conferences and workshops; patient care and support; patient organization development; regulatory decision-making; and reimbursement decision-making. Existing opportunities were not described in sufficient detail to allow for the level of involvement to be assessed. Additionally, no information on the impact of involvement within specific opportunities was found. Based on feedback from patients and families, documentation of existing opportunities within Canada is poor.ConclusionsOpportunities for patient, family, and patient organization involvement exist throughout the orphan drug lifecycle. However, based on the information found, it is not possible to determine which opportunities would be most effective at each stage.

Project description:IntroductionThe Biomedical Scientist (BMS) role is established in healthcare, working in laboratory environments to provide diagnostic testing and to monitor treatment effects on a patients' health. The profession is subject to several professional standards which highlight the importance of working in the best interests of the patient and service user. However, Biomedical Scientists have little or no patient contact. This study aimed to determine how Biomedical Scientists evidence that they meet the professional standards and support the achievement of patient outcomes.Materials and methodsThis study utilised a Delphi method to explore the opinions of professional stakeholders to determine whether there was consensus for how this professional group contributes to patient outcomes and offers evidence that they are working in the best interests of the patient. The qualitative 1st round of the study consisted of focus groups and interviews with staff and students on the BSc Biomedical Science awards, Professional, Statutory and Regulatory body (PSRB) representatives and Biomedical Scientists from the National Health Service (NHS). The first-round responses were analysed using thematic analysis which then generated attitude statements which participants scored using a 5-point Likert scale in the 2nd round. Consensus or divergence of opinion was determined based upon a 70% consensus level within each participant group and overall.ResultsFollowing analysis of the 2nd round data, there was divergence of opinion across all stakeholders, with consensus rates being highest in the Biomedical Scientist group (72.7% of statements reached 70% consensus), followed by the student group (54.5% of statements reached 70% consensus) and lowest in the academic group (40.9% of statements reached 70% consensus).DiscussionThis demonstrates a theory-practice gap in both the academic and student groups, suggesting that graduates are insufficiently prepared for their post-graduate role. This gap was particularly evident when discussing topics such as how Biomedical Scientists contribute to patient care, professional registration and working as part of the multi-disciplinary team (MDT). The identification of a theory-practice gap in the education of Biomedical Scientists is a novel finding, indicating that students may graduate with insufficient understanding of the Biomedical Scientist role.

Project description:BackgroundHospitals are increasingly parts of larger care collaborations, rather than individual entities. Organizing and operating these collaborations is challenging; a significant number do not succeed, as it is difficult to align the goals of the partners. However, little research has focused on stakeholders' views regarding hospital collaboration models or on whether these views are aligned with those of hospital management. This study explores Belgian hospital stakeholders' views on the factors affecting hospital collaborations and their perspectives on different models for Belgian interhospital collaboration.MethodsQualitative focus group study on the viewpoints, barriers, and facilitators associated with hospital collaboration models (health system, network, joint venture).ResultsA total of 55 hospital stakeholders (hospital managers, chairs of medical councils, chair of hospital boards and special interest groups) participated in seven focus group sessions. Collaboration in health care is challenging, as the goals of the different stakeholder groups are partly parallel but also sometimes conflicting. Hospital managers and special interest groups favored health systems as the most integrated form. Hospital board members also opted for this model, but believed a coordinated network to be the most pragmatic and feasible model at the moment. Members of physicians' organizations preferred the joint venture, as it creates more flexibility for physicians. Successful collaboration requires trust and commitment. Legislation must provide a supporting framework and governance models.ConclusionsInvolvement of all stakeholder groups in the process of decision-making within the collaboration is perceived as a necessity, which confirms the importance of the stakeholders' theory. The health system is the collaboration structure best suited to enhancing task distribution and improving patient quality. However, the existence of networks and joint ventures is considered necessary in the process of transformation towards more solid hospital collaborations such as health systems.

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Patient Involvement in the Lifecycle of Medicines According to Belgian Stakeholders: The Gap Between Theory and Practice.

Publications

Patient Involvement in the Lifecycle of Medicines According to Belgian Stakeholders: The Gap Between Theory and Practice.

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