Patient-Patient Centered Outcomes Research最新文献

Introduction: 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.

Method: 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.

Results: 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.

Conclusion: 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.

Background and objectives: 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.

Methods: 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.

Results: 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.

Conclusions: 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.

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.

Background: 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.

Objective: 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.

Methods: 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.

Results: 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.

Conclusions: 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.

Following the conceptualization of a well-formulated and relevant research question, selection of an appropriate stated-preference method, and related methodological issues, researchers are tasked with developing a survey instrument. A major goal of designing a stated-preference survey for health applications is to elicit high-quality data that reflect thoughtful responses from well-informed respondents. Achieving this goal requires researchers to design engaging surveys that maximize response rates, minimize hypothetical bias, and collect all the necessary information needed to answer the research question. Designing such a survey requires researchers to make numerous interrelated decisions that build upon the decision context, selection of attributes, and experimental design. Such decisions include considering the setting(s) and study population in which the survey will be administered, the format and mode of administration, and types of contextual information to collect. Development of a survey is an interactive process in which feedback from respondents should be collected and documented through qualitative pre-test interviews and pilot testing. This paper describes important issues to consider across all major steps required to design and test a stated-choice survey to elicit patient preferences for health preference research.

Introduction: Obtaining patient input before healthcare redesign improves patient experience. The Townsville Hospital and Health Service, a regional Australian public health service, seeks to reduce the long wait list for medical specialist appointments by introducing allied health substitution models of care for low-acuity patients. This paper describes a best worst scaling survey conducted to refine attributes associated with outpatient appointments which will be used in a future discrete choice experiment (DCE).

Methods: A literature review was conducted to identify attributes associated with medical specialist outpatient appointments and allied health substitution models. An object (or case 1) best worst scaling (BWS) survey was designed using blocks of a balanced incomplete block design and analysed using multinomial logit and mixed logit models. Patients waiting at local specialist outpatient clinics were invited to complete the survey via an iPad. The interviewer collected field notes, which were analysed using content analysis.

Results: A total of 12 attributes were identified in the literature review and one from local discussion. The 167 completed responses demonstrated the ranking of attributes were diagnostic accuracy, symptom relief, continuity of care, satisfaction with care, healthcare professional, manner and communication, time on waitlist and onward referral. The least important attributes were reassurance offered, appointment wait time, cost and appointment duration.

Conclusions: This BWS survey allows us to reduce the attributes for inclusion in the DCE from 13 to 8. Diagnostic accuracy and symptom relief were of most importance, and appointment wait time and duration were of least importance. This suggests that patients would be willing to be attend different models of care such as allied health primary contact model if clinical outcomes were equivalent to the current medical-led models.

Background: In the context of injectable biologic products approved or in development for chronic spontaneous urticaria (CSU), it is important to capture which treatment attributes matter most to patient and what trade-offs patients are willing to make.

Objectives: The CHOICE-CSU study aimed to quantify patient preferences toward injectable treatment attributes among patients with CSU, inadequately controlled by H1-antihistamines.

Methods: This was a two-phase cross-sectional patient preference study in adult patients with a diagnosis of CSU, inadequately controlled by H1-antihistamines. A qualitative phase collected patients' insights and relevant treatment attributes that mattered to them, and the outputs were used for the quantitative phase to create the actual injectable treatment profiles with attributes and levels such as: efficacy, safety, and mode of administration. The quantitative phase used discrete choice experiment (DCE) methodology. Eligible patients were asked to make hypothetical choices between 12 treatment profile pairs, created by Sawtooth Software^TM. The DCE data were analyzed using hierarchical Bayesian logistic regression models, enabling the quantification of the relative importance of each attribute/level during the decision-making process.

Results: A total of 450 respondents participated in the DCE. The key attributes driving respondent preference amongst injectable treatment options were type of administration device (relative importance 18.5%), complete control of urticaria (relative importance 17.4%), and resolution of angioedema (relative importance 16.4%). Keeping all other attributes and levels equal, the predicted choice share was higher for a profile with an auto-injector versus one with a pre-filled syringe (72.9% versus 27.1%).

Conclusions: The CHOICE-CSU study is the first study to provide a quantitative assessment of preferences that patients with CSU, inadequately controlled by H1-antihistamines, have for injectable treatment attributes. Symptom-free periods are the most important overriding therapy goal for patients, and patients will accept some inconveniences, such as administration mode, to achieve this. Additionally, when efficacy is equivalent, administration ease of injectable therapies is valued by patients. As new CSU oral treatment options emerge, additional testing of patient preference toward oral treatments will be required.

Background and objective: Cancer survivors frequently encounter multiple challenges, including physical, psychological, social, emotional, and financial difficulties. These challenges significantly impact their quality of life and recovery process. This systematic review intends to delineate and assess the evidence gathered from discrete choice experiments, aiming to unravel the preferences of cancer survivors towards their follow-up care.

Methods: A systematic literature review was conducted across PubMed, Web of Science, Embase, CINAHL, PsycINFO, CNKI, Wanfang, and SinoMed databases up to July 2024. Two reviewers independently conducted the screening, data extraction, and quality appraisal of the studies. The collected data were synthesized through a narrative approach. Additionally, semi-quantitative analyses were used to evaluate the frequency, importance, and significance of each attribute.

Results: Eight studies conducted across four countries were analyzed, yielding 41 distinct attributes grouped into eight main categories and 14 subcategories, further refined by subject matter. Despite the differences in payment systems between countries, the type of provider topped the list of preferences for cancer survivors' follow-up care. Next in preference was the contact modality. Service quality (comprehensive plans, personalized service, detailed information) was also valued. However, opinions diverged on continuity, additional support, and service frequency.

Conclusions: The attributes of follow-up care preferences integrated in this review demonstrate a diverse range among cancer survivors. Generally, they prioritize skilled professionals, flexible contact modality, and other high-quality follow-up care elements. Future studies should analyze cancer survivors' preferences for follow-up care from the perspectives of different stakeholders, and further consider internal and external factors to ensure authentic decision making.

Background: Decision-making in lumbar surgery for degenerative conditions is influenced by various factors, including patient expectations and empowerment. The role of patient-reported outcomes (PROs) in guiding these decisions is underexplored. This study aims to understand the perspectives of patients and spine surgeons in decision-making for lumbar surgery and explore their perspectives on the relevance and influence of pre- and post-surgery PROs.

Methods: An exploratory qualitative study was conducted between February 2022 and November 2023. A total of 15 patients with degenerative lumbar conditions and 9 spine surgeons from 5 tertiary public hospitals in Singapore were recruited. Data were analyzed using a framework analysis approach, ensuring validity through member checking, reflexive journals, and data source triangulation.

Results: Three overarching categories emerged: "expectations and outcomes," "decision empowerment," and "surgical experiences." There is a shift toward shared decision-making, highlighting the importance of patient-centric approaches. Surgical decisions are primarily influenced by PROs, particularly health-related quality of life (HRQoL) and pain relief. Patients prioritize pain relief and improvements in daily functioning, while surgeons also emphasize avoiding postoperative complications. Decision support tools, including PRO data, are essential but need better accessibility and integration within clinical settings. Positive surgical experiences are driven by clear communication, trust with surgeons, swift recovery, and no regrets post-surgery.

Conclusions: Our study emphasizes the importance of patient-centered approaches in lumbar surgery decision-making, particularly regarding pre- and post-surgery PROs. Implementing these approaches may enhance patient satisfaction and surgical outcomes, urging the surgical community to prioritize informed, empathetic decision-making to improve healthcare quality.