Patient-Patient Centered Outcomes Research最新文献

{"title":"What Constitutes High-Quality Paediatric Palliative Care? A Qualitative Exploration of the Perspectives of Children, Young People, and Parents.","authors":"Debbie Braybrook, Lucy Coombes, Hannah M Scott, Daney Harðardóttir, Anna Roach, Jemimah Bariuan, Clare Ellis-Smith, Julia Downing, Fliss E M Murtagh, Myra Bluebond-Langner, Lorna K Fraser, Richard Harding, Katherine Bristowe","doi":"10.1007/s40271-025-00744-8","DOIUrl":"https://doi.org/10.1007/s40271-025-00744-8","url":null,"abstract":"<p><strong>Background: </strong>Globally, over 21 million children need palliative care each year. Although guidelines exist to support paediatric palliative care delivery, they are not informed by the experiences of children themselves.</p><p><strong>Objective: </strong>We aimed to determine what constitutes good quality palliative care from the perspectives of children with life-limiting or life-threatening conditions and their parents.</p><p><strong>Methods: </strong>We analysed semi-structured qualitative interviews using reflexive thematic analysis informed by the European Association for Palliative Care charter of palliative care for children and young people, and Bronfenbrenner's bioecological model. Participants included 26 children aged 5-17 years, and 40 parents of children aged 0-17 years, with a range of cancer and non-cancer diagnoses in nine UK paediatric palliative care services (hospitals and hospices).</p><p><strong>Results: </strong>Quality paediatric palliative care can be both enacted or interrupted across the five domains of the bioecological model. Honest timely communication with the child and family (microsystem), and collaborative relationships between care teams and others in the child's life (mesosystem), are vital. Care experiences are negatively affected by inequities in care provision (exosystems), and society's reluctance to discuss mortality in childhood (macrosystem). Children need to enjoy what matters to them, and maintain social connections, and plan for the future, even if facing a shortened life (chronosystem).</p><p><strong>Conclusions: </strong>Children and parents are experts in their condition and should be actively involved in care discussions, through communication tailored to the child's pace and preferences, and support advocating for and coordinating care services. Fostering strong and collaborative relationships builds trust and helps children and families to feel safe, included and supported.</p>","PeriodicalId":51271,"journal":{"name":"Patient-Patient Centered Outcomes Research","volume":" ","pages":""},"PeriodicalIF":3.4,"publicationDate":"2025-05-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144144158","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Determining the Content Validity of the EQ-5D-5L, EQ-5D-Y-3L, and CHU9D Instruments for Assessing Generic Child and Adolescent Health-Related Quality of Life: A Qualitative Study.","authors":"Jill Carlton, Philip A Powell, Andrew Kirkcaldy, Donna Rowen","doi":"10.1007/s40271-025-00743-9","DOIUrl":"https://doi.org/10.1007/s40271-025-00743-9","url":null,"abstract":"<p><strong>Background: </strong>Health technology assessment agencies typically recommend generic measures of health to generate quality-adjusted life-years. Most agencies provide recommendations on which measure to use for adults, whereas few make recommendations for children. Two widely used preference-weighted measures of child and adolescent health that have evidence of good psychometric performance are the EQ-5D-Y-3L and the Child Health Utility 9D Index (CHU9D). The EQ-5D-5L has also been used to assess adolescent health. However, evidence on their content validity-a core measurement property-is limited. The objective of this study was to explore the content validity of the EQ-5D-5L, EQ-5D-Y-3L, and CHU9D measures, including their relevance, comprehensiveness, and comprehensibility.</p><p><strong>Methods: </strong>We assessed the content validity of the EQ-5D-5L, EQ-5D-Y-3L, and CHU9D using online semi-structured cognitive interviews in the UK. Participants were asked to comment on the relevance, comprehensibility, and comprehensiveness of the measures, including response options, recall period, and completion instructions. Interviews were informed by a topic guide. Purposive sampling allowed for appropriate breadth in the sample, with variation in gender, and presence of health conditions, disease, or disability. Interviews were recorded and transcribed verbatim before thematic content analysis.</p><p><strong>Results: </strong>In total, we conducted 49 interviews between August 2022 and June 2023: 21 children/adolescents aged 8-17 years and 28 parents/guardians of children aged 4-17 years. The mean duration of the interviews was 45 min. Relevance was broadly supported, but issues were identified. Comprehensibility was inconsistent on some items, and participants expressed difficulty with grouped items (e.g., 'anxiety/depression'). Participants had difficulty distinguishing qualitatively between some response options (e.g., 'a little bit/a bit'). Some participants noted that instrument comprehensiveness was insufficient.</p><p><strong>Conclusions: </strong>Although the content of the EQ-5D-5L, EQ-5D-Y-3L, and CHU9D was broadly supported, potential problems were identified in aspects of comprehensibility, relevance, and comprehensiveness. These present opportunities for future research and refinement to ultimately improve the content validity of these measures for assessing child and adolescent health.</p>","PeriodicalId":51271,"journal":{"name":"Patient-Patient Centered Outcomes Research","volume":" ","pages":""},"PeriodicalIF":3.4,"publicationDate":"2025-05-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144081756","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Patients' Experiences of Atopic Dermatitis and Nemolizumab Treatment: An In-Trial Interview Study Embedded in a Phase 3 Clinical Trial (ARCADIA).","authors":"Jonathan I Silverberg, Dina Filipenko, Carla Dias Barbosa, Danielle Rodriguez, Olivier Chambenoit, Katrin Jack, Christophe Piketty, Ram Subramanian, Jorge Puelles","doi":"10.1007/s40271-025-00741-x","DOIUrl":"https://doi.org/10.1007/s40271-025-00741-x","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Patients with atopic dermatitis (AD) often experience a multitude of interrelated symptoms and impacts linked to the cardinal symptom of itch. Individual patient-reported outcome measures do not on their own reflect the complex physical and psychosocial burden experienced by patients with AD. This manuscript describes a qualitative in-trial interview substudy embedded in a phase 3 trial of nemolizumab in adults and adolescents with moderate-to-severe AD (ClinicalTrials.gov NCT03985943) and supplements evidence gathered during the core clinical trial.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;Clinical trial participants enrolled at sites in Canada, Australia, Great Britain, and the USA were invited to the substudy. They participated in blinded telephone interviews within 2 weeks of treatment completion. Interviews were conducted in English using a semi-structured interview guide. They explored participants' experiences of AD symptoms and impacts pre-trial and during the trial. Deidentified interview transcripts were coded and analyzed deductively following a content analysis approach. The interview sample was described using sociodemographic and key clinical trial data.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;A total of 73 participants reported 40 pre-trial symptoms, 10 of which affected more than half of the participants. Itch was simultaneously the most common pre-trial symptom and the symptom most commonly perceived as burdensome. Other common burdensome pre-trial symptoms were peeling/flaky/scaly skin (n = 9/43; 21%), skin redness (n = 8/43; 19%), painful skin and dry skin (n = 6/43; 14 % each), and burning sensation (n = 5/43; 12%). Itch was reported by 18% (n = 13/73) of participants to have caused other symptoms, and by a further 12% (n = 9/73) to have impacted their sleep. Participants reported 45 AD-related impact concepts across 6 health-related quality of life domains. Sleep disturbance (n = 20/52; 38%), emotions (n = 14/52; 27%), and daily activities (n = 12/52; 23%) were most often reported as being the most burdensome impact domains. More nemolizumab-than placebo-treated participants reported improvement of the 10 most common pre-trial AD symptoms and all 6 impact domains. More nemolizumab-than placebo-treated participants reported that the treatment helped manage their condition (n = 37/46; 80% versus n = 15/27; 56%), met their expectations (n = 32/46; 70% versus n = 15/27; 56%), and that they would recommend it to others (n = 41/46; 89% versus n = 20/27; 74%).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;This qualitative study captures the heterogeneous symptoms and impacts of AD and highlights the perceived interrelatedness of itch and other AD symptoms and impacts. Our results show that alleviation of itch via targeted treatment may also reduce the complex physical and psychosocial burden of patients with moderate-to-severe AD, underscoring nemolizumab's potential as a valuable addition to existing AD treatments.&lt;/p&gt;&lt;p&gt;&lt;stro","PeriodicalId":51271,"journal":{"name":"Patient-Patient Centered Outcomes Research","volume":" ","pages":""},"PeriodicalIF":3.4,"publicationDate":"2025-05-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144059293","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Preferences for the Use of Artificial Intelligence for Breast Cancer Screening in Australia: A Discrete Choice Experiment.","authors":"Maame Esi Woode, Udeni De Silva Perera, Chris Degeling, Yves Saint James Aquino, Nehmat Houssami, Stacy M Carter, Gang Chen","doi":"10.1007/s40271-025-00742-w","DOIUrl":"https://doi.org/10.1007/s40271-025-00742-w","url":null,"abstract":"<p><strong>Background: </strong>Breast cancer screening is considered an effective early detection strategy. Artificial intelligence (AI) may both offer benefits and create risks for breast screening programmes. To use AI in health screening services, the views and expectations of consumers are critical. This study examined the preferences of Australian women regarding AI use in breast cancer screening and the impact of information on preferences using discrete choice experiments.</p><p><strong>Methods: </strong>The experiment presented two alternative screening services based on seven attributes (reading method, screening sensitivity, screening specificity, time between screening and receiving results, supporting evidence, fair representation, and who should be held accountable) to 2063 women aged between 40 and 74 years recruited from an online panel. Participants were randomised into two arms. Both received standard information on AI use in breast screening, but one arm received additional information on its potential benefits. Preferences for hypothetical breast cancer screening services were modelled using a random parameter logit model. Relative attribute importance and uptake rates were estimated.</p><p><strong>Results: </strong>Participants preferred mixed reading (radiologist + AI system) over the other two reading methods. They showed a strong preference for fewer missed cases with a high attribute relative importance. Fewer false positives and a shorter waiting time for results were also preferred. Strength of preferences for mixed reading was significantly higher compared to two radiologists when additional information on AI is provided, highlighting the impact of information.</p><p><strong>Conclusions: </strong>This study revealed the preferences among Australian women for the use of AI-driven breast cancer screening services. Results generally suggest women are open to their mammograms being read by both a radiologist and an AI-based system under certain conditions.</p>","PeriodicalId":51271,"journal":{"name":"Patient-Patient Centered Outcomes Research","volume":" ","pages":""},"PeriodicalIF":3.4,"publicationDate":"2025-05-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144056649","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Content Validity Assessment of the Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ) Among Adults with Insomnia and Nocturia.","authors":"Miriam Kimel, Leah Kleinman, Tobias Di Marco, Antonio Olivieri, Andrea Schulz, Katherine Kirk, Andrea Phillips Beyer","doi":"10.1007/s40271-025-00733-x","DOIUrl":"10.1007/s40271-025-00733-x","url":null,"abstract":"<p><strong>Purpose: </strong>The study aimed to support use of the Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ) in clinical trials for patients with concomitant insomnia disorder and nocturia.</p><p><strong>Methods: </strong>Eligible participants in this observational study were United States (US) residents aged ≥ 55 years who experienced self-reported symptoms reflecting the diagnostic criteria for insomnia disorder and nocturia (i.e., experienced ≥ 2 nocturnal voids per night within 30 days of screening). Concept elicitation (n = 10), confirmation of limited concepts (n = 5), and cognitive debriefing of the IDSIQ (n = 10) were conducted with 20 participants. A content analysis approach was used.</p><p><strong>Results: </strong>Most participants in the overall sample were female (n = 13/20, 65%) and white (n = 17/20, 85%), with a mean age of 60.9 years. Based on concept elicitation, most participants (n = 9/10, 90%) experienced insomnia 5-7 nights per week and nocturia 7 nights per week. Participants identified impacts to their emotions, social activities, physical abilities, cognitive function, daily activities, work, and family for insomnia disorder and nocturia. These concepts were confirmed with the five additional interviews. Concept saturation for both disorders was achieved in all participants by the seventh concept elicitation interview. All cognitive interview participants (n = 10) understood the IDSIQ instructions, items, and response options.</p><p><strong>Conclusions: </strong>Having concurrent insomnia disorder and nocturia is associated with daytime symptoms and impacts to functioning. All participants who were debriefed understood all IDSIQ items and response options. These findings suggest the IDSIQ is a content-valid instrument for use in clinical trials with patients with insomnia and comorbid nocturia.</p>","PeriodicalId":51271,"journal":{"name":"Patient-Patient Centered Outcomes Research","volume":" ","pages":"249-261"},"PeriodicalIF":3.4,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11985609/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143517259","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Getting Everyone on Board to Break the Cycle of Bacterial Vaginosis (BV) Recurrence: A Qualitative Study of Partner Treatment for BV.","authors":"Alicia J King, Tiffany R Phillips, Erica L Plummer, Natasha Wild, Christopher K Fairley, Eric P F Chow, Lenka A Vodstrcil, Catriona S Bradshaw","doi":"10.1007/s40271-025-00731-z","DOIUrl":"10.1007/s40271-025-00731-z","url":null,"abstract":"<p><strong>Introduction: </strong>Bacterial vaginosis (BV) is a common condition that affects the sexual wellbeing of women and other people with a vagina. Recurrence following individual treatment is frequent and exerts a cumulative burden over time. Researchers at the Melbourne Sexual Health Center have recently completed the first successful trial of male partner treatment (MPT) for BV, demonstrating the superior effectiveness of concurrent MPT in reducing recurrence.</p><p><strong>Method: </strong>Using a case study design, semi-structured interviews with trial participants explored the views and experiences of nine men who had received MPT and nine women whose partners had received MPT. Action and emotion coding were employed to create an explanatory model of experiences of BV recurrence and MPT.</p><p><strong>Results: </strong>Three key themes within this model related to the cycle of recurrent BV: the physical, psychological, and relationship impacts of BV (\"experiencing BV\"); the importance of healthcare providers exploring different options and understanding individual context (\"seeking care\"); and the frustration, cost, and inconvenience of individual treatment (\"dealing with it alone\"). This cycle was broken by \"Getting everyone on board\" with MPT. This involved women, men, and healthcare professionals understanding BV and MPT, overcoming barriers to access, and open communication between partners. These factors, in combination, resulted in couples \"dealing with BV together\", undertaking a week of inconvenience to share the responsibility of preventing recurrence.</p><p><strong>Conclusion: </strong>These findings suggest that the widescale adoption of MPT for BV will require multilevel approaches to address gaps in the awareness of BV with sensitivity to the relational, social, and structural context of delivering care.</p>","PeriodicalId":51271,"journal":{"name":"Patient-Patient Centered Outcomes Research","volume":" ","pages":"279-290"},"PeriodicalIF":3.4,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11985585/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143630306","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Routine Quality-of-Life Measurement in Residential Aged Care: Staff, Resident, and Family Perspectives.","authors":"Andrew Simon Gilbert, Frances Batchelor, Nancy Devlin, Briony Dow, Brendan Mulhern, Rosalie Viney, Tessa Peasgood, Lidia Engel","doi":"10.1007/s40271-025-00729-7","DOIUrl":"10.1007/s40271-025-00729-7","url":null,"abstract":"<p><strong>Background and objectives: </strong>There is interest in routinely measuring quality of life (QoL) in aged care homes, evidenced by the Australian Government's implementation of QoL as a mandatory quality indicator. This study explores views of aged care staff, residents, and family members on the benefits, challenges, and feasibility of implementing routine QoL measures.</p><p><strong>Methods: </strong>Qualitative data were gathered to explore staff, resident, and family perspectives on QoL measurement in aged care homes, including purpose, benefits, implementation, and best practice. Two staff workshops were conducted at different aged care homes, and semi-structured interviews were held with 29 proxies (9 family members and 20 staff) and 24 residents. Workshops and interviews were transcribed verbatim, and thematically analysed via a qualitative interpretive approach using NVivo software.</p><p><strong>Results: </strong>Analysis yielded four key themes: (1) benefits of routine QoL measurement; (2) challenges in implementation; (3) best practice for collecting surveys; (4) validity concerns. Identified benefits included potentially improved care, monitoring service performance, and informing family members. Staff participants recommended integrating measures into existing care planning and having oversight from a registered nurse. Participants identified potential implementation challenges, including administrative burden, time and resourcing constraints, conflicts of interest, and resistance from staff, providers, and residents.</p><p><strong>Conclusions: </strong>This study identifies potential benefits to implementing routine QoL measurement in residential aged care homes. To maximise these benefits, it is important to consider how measurement can be integrated in ways that contribute to existing care planning and practices.</p>","PeriodicalId":51271,"journal":{"name":"Patient-Patient Centered Outcomes Research","volume":" ","pages":"211-223"},"PeriodicalIF":3.4,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11985636/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143082004","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Patient Experience of Treatment with Tirzepatide for Weight Management: Exit Interviews from SURMOUNT-4.","authors":"Chloe Carmichael, Irina Jouravskaya, Elizabeth Collins, Danielle Burns, Jiat Ling Poon, Helen Kitchen, Donna Mojdami, Madhumita Murphy, Nadia Ahmad, Chisom Kanu","doi":"10.1007/s40271-025-00730-0","DOIUrl":"10.1007/s40271-025-00730-0","url":null,"abstract":"<p><strong>Background and objectives: </strong>Tirzepatide is a glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1 receptor agonist, which was approved in 2023 by the US Food and Drug Administration for weight management in adults with obesity or overweight. The purpose of this study was to conduct qualitative exit interviews with participants who had participated in the SURMOUNT-4 clinical trial, to better understand the patient experience of tirzepatide.</p><p><strong>Methods: </strong>Online exit interviews were conducted with adults from the USA who had participated in the SURMOUNT-4 clinical trial for weight management, recruited from 16 US-based SURMOUNT-4 clinical sites. Interviews utilized a semi-structured interview guide, and included questions related to receiving tirzepatide, using a single-use injection pen device, and the overall trial experience. Interviews were audio recorded and transcribed, and analyzed using a content analysis.</p><p><strong>Results: </strong>Eighty-six adults (83% female; mean age 49.9 years) participated in the interviews. All participants shared at least one perceived benefit of tirzepatide experienced during the open-label phase of SURMOUNT-4, including improved appetite control, increased energy, or improved clothing fit. Despite the gastrointestinal side effects experienced, many participants liked the efficacy of tirzepatide, and reported that the single-use injection pen device for administering the study medication was easy to use. Most participants were willing to continue taking tirzepatide.</p><p><strong>Conclusions: </strong>Study findings showed that beyond the direct pharmacological effects of treatment with tirzepatide, participants reported a wide range of perceived improvements across several aspects of their lives. Participants also reported a few negative experiences, including side effects. It is possible that the participants who had a more positive experience were more inclined to participate in the exit interviews. This study highlights the value of exit interviews, which can provide more learning about patient experiences during a clinical trial.</p>","PeriodicalId":51271,"journal":{"name":"Patient-Patient Centered Outcomes Research","volume":" ","pages":"225-236"},"PeriodicalIF":3.4,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11985590/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143477193","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Qualitative In-trial Interviews: Methods, Challenges, and Best Practice.","authors":"Nicola Williamson, Chloe Howse, Nicola Hodson, Julia Stein, Rob Arbuckle","doi":"10.1007/s40271-024-00726-2","DOIUrl":"10.1007/s40271-024-00726-2","url":null,"abstract":"<p><p>Qualitative in-trial interviews with clinical trial participants are a means of providing rich, in-depth patient experience data to supplement and complement data captured by clinical outcome assessments and other clinical trial efficacy endpoints. Such in-trial interview data can be used to build understanding of disease and treatment experiences, evaluate content validity of clinical outcome assessments, aid interpretation of scores and meaningful changes, inform trial design feasibility and operational considerations, and provide supportive evidence regarding safety, efficacy, and effectiveness. Despite the rapid growth of in-trial interviews as part of clinical development programs in the pharmaceutical industry in recent years, published guidelines regarding the methods, conduct, and implementation of in-trial interviews are scarce. Drawing on published examples and the authors' experiences of conducting in-trial interview studies, this article provides an overview of best practice methods for implementing this methodology (including considerations for study design, sample size, interview conduct, and analysis) and the value of in-trial interview data to answer specific research questions. Operational and logistical considerations are outlined, including recommendations for country selection, site selection, training and communication, adverse event safety reporting, and data management and handling. Well-designed and carefully implemented in-trial interviews can lead to generation of insightful patient experience data that are truly of value to inform regulators, health technology agencies, clinicians, patients, and caregivers about product attributes and the impact of diseases and treatments on patients' lives.</p>","PeriodicalId":51271,"journal":{"name":"Patient-Patient Centered Outcomes Research","volume":" ","pages":"199-209"},"PeriodicalIF":3.4,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143081957","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Unveiling Preferences in Closed Communities: Development of a Discrete Choice Experiment (DCE) Questionnaire to Elicit Ultra-Orthodox Women Preferences for Video Consultations in Primary Care.","authors":"Irit Chudner, Anat Drach-Zahavy, Batya Madjar, Leah Gelman, Sonia Habib","doi":"10.1007/s40271-025-00734-w","DOIUrl":"10.1007/s40271-025-00734-w","url":null,"abstract":"<p><strong>Background: </strong>Video consultations in primary care settings demonstrate substantial benefits, including improved accessibility, reduced waiting times, and enhanced health management. These services could particularly benefit ultra-Orthodox women in Israel, who typically manage large families and face unique healthcare access challenges as primary caregivers. However, eliciting preferences within this closed religious community presents distinct methodological challenges because of cultural sensitivities and religious restrictions regarding technology use.</p><p><strong>Objective: </strong>We aimed to develop and validate a culturally sensitive, discrete choice experiment questionnaire for eliciting ultra-Orthodox women's preferences regarding video versus in-clinic consultations in primary care settings.</p><p><strong>Methods: </strong>A three-stage mixed-methods approach was employed: (1) 33 semi-structured interviews with key stakeholders (women, men, rabbis, and healthcare providers) to identify attributes and levels; (2) an attribute-ranking exercise with 88 ultra-Orthodox women to refine attributes; and (3) cognitive interviews with 15 women to validate the discrete choice experiment questionnaire.</p><p><strong>Results: </strong>Four key attributes emerged as most important for ultra-Orthodox women when choosing between video and in-clinic consultations: (1) consultation timing (regular hours/after 20:00); (2) travel time; (3) waiting time; and (4) familiarity with the healthcare provider. Importantly, the study revealed the necessity for a dedicated device exclusively for healthcare provider communication, closed to open Internet networks, as a fundamental prerequisite for implementing video consultations in this community. Additional unique findings emerged through this methodological process, contributing to the understanding of technological adoption in closed religious patients' communities.</p><p><strong>Conclusions: </strong>This study provides a comprehensive example of implementing pre-discrete choice experiment stages while addressing unique considerations of a special population. The findings provide a framework for developing inclusive telemedicine services for traditionally underserved populations.</p>","PeriodicalId":51271,"journal":{"name":"Patient-Patient Centered Outcomes Research","volume":" ","pages":"263-277"},"PeriodicalIF":3.4,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11985673/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143606819","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}