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Factors and Situations Affecting the Value of Patient Preference Studies: Semi-Structured Interviews in Europe and the US.

ABSTRACT: Objectives: Patient preference information (PPI) is gaining recognition among the pharmaceutical industry, regulatory authorities, and health technology assessment (HTA) bodies/payers for use in assessments and decision-making along the medical product lifecycle (MPLC). This study aimed to identify factors and situations that influence the value of patient preference studies (PPS) in decision-making along the MPLC according to different stakeholders. Methods: Semi-structured interviews (n = 143) were conducted with six different stakeholder groups (physicians, academics, industry representatives, regulators, HTA/payer representatives, and a combined group of patients, caregivers, and patient representatives) from seven European countries (the United Kingdom, Sweden, Italy, Romania, Germany, France, and the Netherlands) and the United States. Framework analysis was performed using NVivo 11 software. Results: Fifteen factors affecting the value of PPS in the MPLC were identified. These are related to: study organization (expertise, financial resources, study duration, ethics and good practices, patient centeredness), study design (examining patient and/or other preferences, ensuring representativeness, matching method to research question, matching method to MPLC stage, validity and reliability, cognitive burden, patient education, attribute development), and study conduct (patients' ability/willingness to participate and preference heterogeneity). Three types of situations affecting the use of PPS results were identified (stakeholder acceptance, market situations, and clinical situations). Conclusion: The factors and situation types affecting the value of PPS, as identified in this study, need to be considered when designing and conducting PPS in order to promote the integration of PPI into decision-making along the MPLC.

SUBMITTER: Whichello C

PROVIDER: S-EPMC6759933 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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Factors and Situations Affecting the Value of Patient Preference Studies: Semi-Structured Interviews in Europe and the US.

Whichello Chiara C van Overbeeke Eline E Janssens Rosanne R Schölin Bywall Karin K Russo Selena S Veldwijk Jorien J Cleemput Irina I Juhaeri Juhaeri J Levitan Bennett B Kübler Jürgen J Smith Meredith M Hermann Richard R Englbrecht Matthias M Hueber Axel J AJ Comanescu Alina A Harding Sarah S Simoens Steven S Huys Isabelle I de Bekker-Grob Esther W EW

Frontiers in pharmacology 20190918

<b>Objectives:</b> Patient preference information (PPI) is gaining recognition among the pharmaceutical industry, regulatory authorities, and health technology assessment (HTA) bodies/payers for use in assessments and decision-making along the medical product lifecycle (MPLC). This study aimed to identify factors and situations that influence the value of patient preference studies (PPS) in decision-making along the MPLC according to different stakeholders. <b>Methods:</b> Semi-structured interv ...[more]

PMID: 31619989

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Project description:BackgroundPatient preferences (PP), which are investigated in PP studies using qualitative or quantitative methods, are a growing area of interest to the following stakeholders involved in the medical product lifecycle: academics, health technology assessment bodies, payers, industry, patients, physicians, and regulators. However, the use of PP in decisions along the medical product lifecycle remains limited. As the adoption of PP heavily relies on these stakeholders, knowledge of their perceptions of PP is critical.ObjectiveThis study aimed to characterize stakeholders' attitudes, needs, and concerns with respect to PP in decision making along the medical product lifecycle.MethodsSemi-structured interviews (n = 143) were conducted with academics (n = 24), health technology assessment/payer representatives (n = 24), industry representatives (n = 24), patients, caregivers and patient representatives (n = 24), physicians (n = 24), and regulators (n = 23) from seven European countries and the USA. Interviews were conducted between April and August 2017. The framework method was used to organize the data and identify themes and key findings in each interviewed stakeholder group.ResultsInterviewees reported being unfamiliar (43%), moderately familiar (42%), or very familiar (15%) with preference methods and studies. Interviewees across stakeholder groups generally supported the idea of using PP in the medical product lifecycle but expressed mixed opinions about the feasibility and impact of using PP in decision making. Interviewees from all stakeholder groups stressed the importance of increasing stakeholders' understanding of the concept of PP and preference methods and ensuring patients' understanding of the questions asked in PP studies. Key concerns and needs in each interviewed stakeholder group were as follows: (1) academics: investigating the validity, reliability, reproducibility, and generalizability of preference methods; (2) health technology assessment/payer representatives: developing quality criteria for evaluating PP studies and gaining insights into how to weigh them in reimbursement/payer decision making; (3) industry representatives: obtaining guidance on PP studies and recognition on the importance of PP from decision makers; (4) patients, caregivers, and patient representatives: providing an incentive and adequate information towards patients when participating in PP studies; (5) physicians: avoiding bias as a result of commercial agendas in PP studies and clarifying how to deal with subjective and emotional elements when measuring PP; and (6) regulators: avoiding the misuse of PP study results to overrule the traditional efficacy and safety criteria used for marketing authorization and obtaining robust PP study results.ConclusionsDespite the interest all interviewed stakeholder groups reported in PP, the effective use of PP in decision making across the medical product lifecycle is currently hampered by a lack of standardization and consensus on how to both measure and use PP.

Project description:BackgroundNew ways of reimbursement for high-cost, one-shot curative therapies such as advanced therapy medicinal products (ATMPs) are a growing area of interest to stakeholders in market access such as industry representatives, legislative and accounting experts, physicians, hospital managers, hospital pharmacists, patient representatives, policymakers, and sickness funds. Due to the complex nature of ATMPs, new payment models and reimbursement modalities are proposed yet not widely applied across Europe.ObjectivesThis study aimed to elicit opinions on and insights into the governance aspect of implementing outcome-based spread payments (OBSP) in Belgium for the reimbursement of innovative therapies. Stakeholders' responsibilities and roles were analysed and proposed solutions or general beliefs were assessed to identify necessary or sufficient conditions to establish outcome-based spread payments.MethodsSemi-structured interviews (n = 33) were conducted with physicians (n = 2), hospital pharmacists (n = 4), hospital managers (n = 2), Belgian policymakers (n = 6), legislative experts (n = 2), accounting experts (n = 5), representatives of patients (n = 3), of industry (n = 5), and sickness funds (n = 4). The interviews took place between July 2020 and October 2020. The framework method analysis was performed using Nvivo software (version 20.4.1.851). Statements were allocated into six main topics: payment structure, spread payments, outcome-based agreements, governance, transparency, and regulation.ResultsInterviews revealed the necessary conditions that, fulfilled together, are seen to be sufficient for the successful implementation of OBSP, including consensus on pricing, payment logistics, robust data infrastructure and financing, clear agreement terms (duration, outcome parameters, payment triggers), long-term patient follow-up solutions, an external multi-stakeholder governance body, and transparency regarding agreement types.ConclusionDespite the interest, the effective implementation of OBSP falls behind due to a lack of consensus on how this new reimbursement method can be a sustainable solution. By stating the necessary conditions that, when fulfilled together, are deemed sufficient for successful OBSP implementation, this study provides a framework towards overcoming implementation barriers and realizing the potential of OBSP in transforming healthcare reimbursement practices.

Project description:BackgroundDifferent diagnostic interviews are used as reference standards for major depression classification in research. Semi-structured interviews involve clinical judgement, whereas fully structured interviews are completely scripted. The Mini International Neuropsychiatric Interview (MINI), a brief fully structured interview, is also sometimes used. It is not known whether interview method is associated with probability of major depression classification.AimsTo evaluate the association between interview method and odds of major depression classification, controlling for depressive symptom scores and participant characteristics.MethodData collected for an individual participant data meta-analysis of Patient Health Questionnaire-9 (PHQ-9) diagnostic accuracy were analysed and binomial generalised linear mixed models were fit.ResultsA total of 17 158 participants (2287 with major depression) from 57 primary studies were analysed. Among fully structured interviews, odds of major depression were higher for the MINI compared with the Composite International Diagnostic Interview (CIDI) (odds ratio (OR) = 2.10; 95% CI = 1.15-3.87). Compared with semi-structured interviews, fully structured interviews (MINI excluded) were non-significantly more likely to classify participants with low-level depressive symptoms (PHQ-9 scores ≤6) as having major depression (OR = 3.13; 95% CI = 0.98-10.00), similarly likely for moderate-level symptoms (PHQ-9 scores 7-15) (OR = 0.96; 95% CI = 0.56-1.66) and significantly less likely for high-level symptoms (PHQ-9 scores ≥16) (OR = 0.50; 95% CI = 0.26-0.97).ConclusionsThe MINI may identify more people as depressed than the CIDI, and semi-structured and fully structured interviews may not be interchangeable methods, but these results should be replicated.Declaration of interestDrs Jetté and Patten declare that they received a grant, outside the submitted work, from the Hotchkiss Brain Institute, which was jointly funded by the Institute and Pfizer. Pfizer was the original sponsor of the development of the PHQ-9, which is now in the public domain. Dr Chan is a steering committee member or consultant of Astra Zeneca, Bayer, Lilly, MSD and Pfizer. She has received sponsorships and honorarium for giving lectures and providing consultancy and her affiliated institution has received research grants from these companies. Dr Hegerl declares that within the past 3 years, he was an advisory board member for Lundbeck, Servier and Otsuka Pharma; a consultant for Bayer Pharma; and a speaker for Medice Arzneimittel, Novartis, and Roche Pharma, all outside the submitted work. Dr Inagaki declares that he has received grants from Novartis Pharma, lecture fees from Pfizer, Mochida, Shionogi, Sumitomo Dainippon Pharma, Daiichi-Sankyo, Meiji Seika and Takeda, and royalties from Nippon Hyoron Sha, Nanzando, Seiwa Shoten, Igaku-shoin and Technomics, all outside of the submitted work. Dr Yamada reports personal fees from Meiji Seika Pharma Co., Ltd., MSD K.K., Asahi Kasei Pharma Corporation, Seishin Shobo, Seiwa Shoten Co., Ltd., Igaku-shoin Ltd., Chugai Igakusha and Sentan Igakusha, all outside the submitted work. All other authors declare no competing interests. No funder had any role in the design and conduct of the study; collection, management, analysis and interpretation of the data; preparation, review or approval of the manuscript; and decision to submit the manuscript for publication.

Project description:Background and objectivesMany donors and recipients report an improved bond posttransplantation; however, unexpected conflicts and tension may also occur. Insights into the lived experiences of the donor-recipient relationship can inform strategies for interventions and support. We aimed to describe donor and recipient expectations and experiences of their relationship before and after living kidney donor transplantation.Design, setting and participantsSemistructured interviews were conducted with 16 donor-recipient pairs before the transplant and 11-14 months post-transplant. Transcripts were analysed thematically.ResultsWe identified seven themes (with respective subthemes): donation as enacting familial responsibility for care; analytical decision making to mitigate regret (avoiding anticipated regret and maintaining control, removing emotional impulsivity); strengthened interpersonal ties (gaining a deeper appreciation among family members, stronger empathy for each other, improving social participation); instability of relational impacts (anger and aggression threatening dynamics, unanticipated stress and emotional lability, triggering familial tension); renegotiating social roles (unexpected continuation of caregiving responsibilities, inability to relinquish the caregiving role, disappointment with unfulfilled renewal of intimacy, dissatisfaction over discrepant energy levels); guilt over unmet expectations and inevitability of the gift relationship (vague and transient indebtedness, expectation of reciprocity, transferring kidney ownership).ConclusionsDonor-recipient relationships may be improved through increased empathy, appreciation, and ability to participate in life together; however, unfulfilled expectations and behavioural and emotional changes in recipients (a side effect related to immunosuppression) remain unresolved consequences of living kidney donor transplantation. Education and counselling to help donors and recipients adjust to potential changes in relationship dynamics may help protect and foster relational stability postdonation.

Project description:BACKGROUND:Patients within safety-net settings are less likely to access health information on patient portals, despite expressed interest. Family and friends are important resources to assist these patients (ie, Medicaid recipients, older patients, patients with limited English proficiency) in navigating health systems, and provider support of the use of patient portals among these groups may also facilitate caregivers' use of their patients' portal. OBJECTIVE:Because safety net providers work closely with caregivers to care for their patients, we used qualitative methods to explore safety net providers' perspectives on portal use among caregivers for their patients, especially as there is limited literature about caregivers' use of portals in the safety net. METHODS:We conducted 45- to 60-min semistructured telephone interviews with providers from three large California safety-net health systems. The interviews focused on providers' experiences with caregivers, caregiver roles, and how the portal could be leveraged as a tool to support caregivers in their responsibilities. A total of three coders analyzed the interview transcripts using both deductive and inductive approaches and established a consensus regarding major themes. RESULTS:Of the 16 participants interviewed, 4 specialized in geriatrics, and all held a leadership or administrative role. We described themes highlighting providers' recognition of potential benefits associated with caregiver portal use and specific challenges to caregiver engagement. CONCLUSIONS:Providers recognized the potential for portals to improve information delivery and communication by helping caregivers assist socially and medically complex patients in the safety net. Providers in safety net sites also discussed a clear need for better ways to keep in touch with patients and connect with caregivers, yet security and privacy are perhaps of higher importance in these settings and may pose challenges to portal adoption. They noted that caregivers of patients in the safety net likely face similar communication barriers as patients, especially with respect to digital literacy, health literacy, and English proficiency. Further research is needed to assess and support caregivers' interest and ability to access portals across barriers in health and digital literacy, and English proficiency. Portal platforms and health systems must also address specific strategies to uphold patient preferences while maintaining privacy and security.

Project description:Objectives: A factor contributing to the value of patient preference studies is patient centricity. This study aimed to explore how patients want to be involved in the design and conduct of patient preference studies. In addition, we investigated patients' expectations regarding the communication of study results back to patients. Methods: Semi-structured interviews were conducted with patient representatives within three different disease areas: rheumatic diseases, cancer, and neuromuscular disorders. For each disease area, interviews were conducted with interviewees from Belgium, the Netherlands and the United Kingdom. Interviews followed a predefined interview guide covering topics relating to timing, level, and requirements for patient involvement in patient preference studies, as well as communication of results. Interviews were audio-recorded, transcribed and analyzed using framework analysis in NVivo 12. Results: A total of 14 interviews were conducted. Some interviewees believed that patients should be involved in all steps of a patient preference study. Patient involvement seemed most valuable during the design phase to support defining research questions and instrument design. During analysis, patients can be involved for optimal interpretation of results. Most interviewees mentioned that patient involvement should be on the level of advice or collaboration, not control. Interviewees expressed requirements for patient involvement relating to the knowledge of the involved patient, time investment, compensation and other incentives. Regarding communication of results, most interviewees wished to receive a brief and lay summary of the results, followed by a detailed explanation of both individual and average results accompanied by visuals. Conclusions: Patient involvement in patient preference studies could increase question comprehension by study participants and ensure correct interpretation of results by researchers. Patients want to be involved as advisors or collaborators, and considering their personal situation as well as establishing agreements on roles, time involvement and compensation early on will result in a most optimal partnership.

Dataset Information

Factors and Situations Affecting the Value of Patient Preference Studies: Semi-Structured Interviews in Europe and the US.

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Factors and Situations Affecting the Value of Patient Preference Studies: Semi-Structured Interviews in Europe and the US.

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