Journal of Patient-Reported Outcomes最新文献

Background: Coronary artery disease (CAD) confers increased risks of premature mortality, non-fatal morbidity, and significant impairment in functional status and health-related quality of life. Routine administration of electronic patient-reported outcome measures (PROMs) and its real time delivery to care providers is known to have the potential to inform routine cardiac care and to improve quality of care and patient outcomes. This study describes a user-centered development and evaluation of the Alberta Provincial Project for Outcomes Assessment (APPROACH) electronic Patient Reported Outcomes Measurement (e-PROM) system. This e-PROM system is an electronic system for the administration of PROMs to patients with CAD and the delivery of the summarized information to their care providers to facilitate patient-physician communication and shared decision-making. This electronic platform was designed to be accessible via web-based and hand-held devices. Heuristic and user acceptance evaluation were conducted with patients and attending care providers.

Results: The APPROACH e-PROM system was co-developed with patients and care providers, research investigators, informaticians and information technology experts. Five PROMs were selected for inclusion in the online platform after consultations with patient partners, care providers, and PROMs experts: the Seattle Angina Questionnaire, Patient Health Questionnaire, EuroQOL, and Medical Outcomes Study Social Support Survey, and Self-Care of Coronary Heart Disease Inventory. The heuristic evaluation was completed by four design experts who examined the usability of the prototype interfaces. User acceptance testing was completed with 13 patients and 10 cardiologists who evaluated prototype user interfaces of the e-PROM system.

Conclusion: Both patients and physicians found the APPROACH e-PROM system to be easy to use, understandable, and acceptable. The APPROACH e-PROM system provides a user-informed electronic platform designed to incorporate PROMs into the delivery of individualized cardiac care for persons with CAD.

Background: Individuals may experience a range of symptoms after the clearance of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. This condition is termed long COVID (LC) or Post-COVID-19 condition (PCC). Despite the appreciable number of symptoms documented to date, one key challenge remains in the robust characterization of LC outcomes. This review aimed to assess the properties, identify gaps, and provide recommendations for relevant descriptive and evaluative Patient-Reported Outcome Measurement (PROM) instruments that can be used to comprehensively characterize LC.

Methods: To achieve this objective, we identified and reviewed descriptive and evaluative PROM instruments that have been developed and validated to date with people living with LC. Our review assessed their properties, identified gaps, and recommended PROMs suitable for characterizing LC. To ensure a comprehensive and robust characterization of LC, we next identified, reviewed, and selected (with the input of patient partners) PROMs associated with the most frequently reported LC symptoms. The evaluation criteria included psychometric evidence, mode of delivery, cost, and administration time.

Results: Traditional matrix mapping revealed Post-COVID Functional Status Scale (PCFS) as a choice instrument for capturing LC outcomes largely because of the comprehensive domains it covered, and the number of psychometric evidence reported in literatures. This instrument can be effectively paired with the Fatigue Severity Scale (FSS), Montreal Cognitive Assessment (MoCA), Patient Health Questionnaire (PHQ-9), Headache Impact Test (HIT), Pittsburgh Sleep Quality Index (PSQI), and DePaul Symptom Questionnaire (DSQ-PEM) to characterize fatigue, cognitive impairment, depression/anxiety, headache, sleeplessness, and post-exertional malaise respectively.

Conclusion: Our paper identified appropriate PROM instruments that can effectively capture the diverse impacts of LC. By utilizing these validated instruments, we can better understand and manage LC.

Background: The COVID-19 pandemic resulted in unprecedented changes to cancer care in many countries, impacting cancer patients' lives in numerous ways. This study examines the impact of changes in cancer care on patient's health-related quality of life (HRQL), which is a key outcome in cancer care. The study aims to estimate patients' self-reported HRQL before and during the pandemic and identify predictive factors for their physical and mental wellbeing.

Method: The study employed the large-scale Outpatient Cancer Care (OCC) Patient Experience Survey, including the Veterans RAND 12-Item Health Survey, to evaluate cancer patients' experiences and HRQL before (January to May 2020) and during the COVID-19 pandemic (May to July 2021). Paired t-tests were conducted to compare differences in Physical Component Scores (PCS) and Mental Component Scores (MCS) before and during the pandemic. Multivariable linear regressions were employed to investigate the factors (sociodemographic, clinical, and patient-reported experience) influencing PCS and MCS during the pandemic.

Results: PCS decreased significantly during the pandemic, while MCS remained stable. Lower PCS contributors included older age, more telehealth visits, self-reported hospitalization, and a longer time since the last cancer diagnosis. Higher PCS was associated with urban residence, higher MCS during the pandemic, and perceived active Healthcare Provider (HCP) involvement. For MCS, lower scores related to female gender and more telehealth visits, while higher scores were associated with being white, higher education, high MCS before the pandemic, and perceived active HCP involvement.

Conclusion: The OCC Patient Experience Survey provides a unique patient level data set measuring HRQL pre- and post- the onset of the COVID-19 pandemic. The study highlights challenges faced by cancer patients during the pandemic, with a significant reduction in PCS. However, the stability in MCS suggests effective coping mechanisms. Sociodemographic, clinical, and telehealth-related variables play a complex role in shaping both PCS and MCS. Perceived HCP involvement emerges as a crucial factor correlating with higher PCS and MCS. Navigating the post-pandemic era necessitates interventions fortifying patient-provider relationships, optimizing healthcare support systems, such as telehealth services, and prioritizing mental-well-being given its impact on both PCS and MCS.

Background: There are limited tools to measure the burden of disease and effectiveness of medical/surgical interventions in patients with cryptoglandular fistulas. The aim of this study was to explore concepts that are relevant and important to patients with complex cryptoglandular fistulas (CCF) and to develop a patient-centred, disease-specific, patient-reported outcome measure (PROM) to assess symptom burden and impacts of CCF.

Methods: A targeted literature review was conducted, followed by one-to-one telephone interviews with five colorectal surgeons (USA, n = 3; UK, n = 1; Spain, n = 1) and 20 US adult patients with CCF to inform the development of a conceptual model and a CCF-specific PROM. The targeted literature review informed the development of the preliminary conceptual model and identified a PROM in the literature that was used as a reference to generate the draft CCF-specific PROM. The colorectal surgeon interviews provided insights on the experience of patients with CCF to refine the conceptual model, formulate probing questions for use in patient interviews, and to develop the draft CCF-specific PROM. Patients' descriptions of their experiences with symptoms and the impacts on their lives and evaluation of the draft CCF-specific PROM in concept elicitation and cognitive interviews were used to develop the final conceptual model and final CCF-specific PROM.

Results: Ten symptoms (odour, pain during bowel movement, abscess, post-operative pain, discharge/drainage/leakage, anal/perianal pain, inflammation/swelling, skin irritation, bleeding and itchiness) and 11 impacts (discomfort, inability to exercise, embarrassment, difficulty sitting, worry about disease, adapted life to maintain hygiene, negatively impacted social life/isolation, inability to perform daily activities, reduced interest in sex, negatively impacted intimate relationships and negatively impacted mood) were reported as most salient by patients. The patient experience, clinician perspective, and literature review provided input to item generation. Evaluation of relevance and patient understanding through cognitive interviews with patients provided evidence for the content validity of the new patient-reported outcome measure: the 20-item Complex Cryptoglandular Fistula Questionnaire^™ (CCFQ-20^™).

Conclusion: The CCFQ-20^™ is a new clinician-guided, patient-validated, disease-specific patient-reported outcome measure that measures disease impact and quality of life in patients with CCF.

Background: Addressing Patient Reported Outcomes (PROs) is essential for patient-centred care, shared decision making and improved health outcomes. Value-based health care systems in New South Wales (NSW) have a growing focus on collecting and using PROs that matter most to patients to improve their healthcare outcomes. Developing oral health patient reported outcomes measures (OH-PROM) is a first step towards value-based oral health care. This paper describes the development process of an adult and child OH-PROM tool that can be piloted for NSW public dental patients.

Methods: An expert panel was assembled to undertake a systematic process of developing OH-PROMs for NSW Health. Key methodological considerations included: (1) forming an expert panel to specify the target population and context of implementation, (2) rapid literature review and environmental scan to identify existing validated OH-PROM tools for adults and children. (3) consensus gathering with the expert panel (4) consumer feedback, and (5) finalisation of the tool for electronic oral health record (eOHR) integration to establish a set of questions, that were relevant, context-appropriate, and important to oral healthcare outcomes for patients using public dental services.

Results: The panel considered a total of 59 questions from two child (15), and four adult (44) Oral Health Related Quality of Life (OHRQoL) questionnaires used to collect OH-PROMs. These questions were mapped to the four key dimensions of OHRQoL for OH-PROMs: Oral Function, Orofacial Pain, Orofacial Appearance, and Psychosocial Impact. The consensus resulted in seven questions that aligned with these four dimensions to form two new NSW OH-PROM tools: one for adults and one for children. The tools were tested with consumers for understandability and usefulness before being incorporated into the electronic oral health record system, in readiness for future pilot testing.

Conclusion: The process for developing new OH-PROMs for NSW public dental services took a pragmatic approach that combined literature appraisal, expert consensus, and consumer consultation. Future work will assess the implementation of the OH-PROM tool and test its validity for broader use as an outcome measure for value-based oral healthcare.

Background: Breast cancer is one of the most common cancers in women. Patient-reported outcome measures are used to evaluate patients' health-related quality of life in clinical breast cancer studies. This study evaluated the structure, validity, reliability, and responsiveness of the National Comprehensive Cancer Network-Functional Assessment of Cancer Therapy-Breast Cancer Symptom Index (NFBSI-16) subscales in a clinical trial featuring patients with advanced/metastatic breast cancer (aBC), and estimated NFBSI-16 meaningful change thresholds.

Methods: Data from 101 patients with aBC enrolled in a phase II trial (Xenera-1) were included for psychometric evaluation of the NFBSI-16. Subscale structure was evaluated by assessing inter-item correlations, item-total correlations, and internal consistency (cycles 2 and 5). Validity was assessed using scale-level convergent validity (cycles 2 and 5) and known-groups (Baseline). Reliability was analysed via test-retest at cycles 3-4, and responsiveness to improvement and worsening was evaluated at cycles 5, 7, and 9. Meaningful change thresholds were estimated using anchor-based methods (supported by distribution-based methods) at cycles 5, 7, and 9.

Results: NFBSI-16 internal consistency was acceptable, but item-total correlations suggested that its subscales and the GP5 item (side-effect of treatment) scores may be preferred over a total score. Convergent and known-groups evidence supported NFBSI-16 validity. Test-retest reliability was good to excellent for Total and DRS-P (disease-related symptoms: physical) scales, and moderate for the GP5 item. Responsiveness to worsening was generally demonstrated, but responsiveness to improvement could not be demonstrated due to limited observed improvement. Anchor-based meaningful change thresholds were estimated for DRS-P and Total scores.

Conclusion: This study provides evidence that the NFBSI-16 has desirable psychometric properties for use in clinical studies in aBC. It also provides estimates of group- and individual-level meaningful change thresholds to facilitate score interpretation in future aBC research.

Background: The Otology Questionnaire Amsterdam (OQUA) is developed to evaluate multiple ear complaints and their impact on patients' daily lives. The current clinical use of this questionnaire is below the potential utilization.

Aim: To identify the barriers and enablers of using the OQUA as perceived by ENT surgeons and patients and provide recommendations for an implementation strategy.

Methods: Prospective and qualitative analysis was performed using focus groups and interviews with ENT professionals (n = 15) and patients (n = 25) with ear complaints of one tertiary referral hospital and two regional hospitals. Barriers and enablers were identified and classified by using the Capability-Opportunity-Motivation-Behavior model and the Theoretical Domains Framework. Suggestions for an implementation strategy will be made accordingly.

Results: ENT professionals' barriers included lack of knowledge and skills to use the OQUA, inadequate technological support and perceived time constraints during consultation, uncertainty about the clinical relevance and lack of feedback on the outcomes of the OQUA. Enablers included beneficial consequences of the OQUA for the professional, organization and science. Patients' barriers included lack of knowledge about the objective and usefulness of the OQUA, perceived burden, difficulties in completing the questionnaire and insufficient feedback during consultation. Patient enablers included beliefs about beneficial consequences of the OQUA for the patient, health care and society. Suggested interventions involved education, training, environmental restructuring and incentivisation.

Conclusion: Based on the findings, we propose an implementation strategy should focus on education and training about the objective, outcomes and relevance of the OQUA, environmental restructuring regarding the optimal use of the OQUA, and incentivisation with feedback on the valuable outcomes of the OQUA for the patient, professional and healthcare. Future research is needed to determine the feasibility of the implementation strategy.

Background: Vestibular schwannomas (VSs) are benign tumors of the vestibulocochlear nerve that often cause significant neurological and functional impairment. Patient-reported outcomes, including quality of life (QoL), are essential for understanding the overall impact of VS and its treatment. This study aimed to translate and culturally adapt the Vestibular Schwannoma Quality of Life (VSQOL) Index into German to expand its relevance to German-speaking populations.

Methods: We used a qualitative approach including translation and cognitive interviews with 10 patients who underwent VS surgery. The translation process followed the TRAPD protocol to ensure linguistic and conceptual accuracy. Cognitive interviews assessed the comprehensibility and relevance of the translated questionnaire.

Results: The translation showed remarkable consistency between translators, with minor discrepancies resolved by consensus. Cognitive interviews provided valuable insights that led to refinements in item wording. Participants emphasized the importance of an additional item on physician referrals, reflecting differences in health care systems between the United States and Germany.

Conclusions: The German VSQOL provides a comprehensive tool for assessing QoL in patients with VS that integrates patient-centered dimensions. A Validation study is underway to establish its reliability and validity.

Background: In recent decades, there has been a growing emphasis on involving patients in healthcare decision-making, driven by political, ethical, and research considerations. Although patient involvement is associated with improved health outcomes, understanding patient preferences regarding their role in decision-making is crucial for effective interventions. The Control Preferences Scale (CPS) measures patient preferences along a continuum from passive to active participation. However, its application in Denmark necessitates translation and cultural adaptation.

Methodology: This study aimed to translate and culturally adapt the CPS for Danish use across diverse healthcare settings: acute care, cancer care, elective surgery, chronic medical treatment, and parental involvement in pediatric care. Following a cross-sectional design, the translation process was systematically planned and executed using Beaton's guidelines, including the five stages: forward and back translation, synthesis, expert review, and pre-testing.

Results: The translation and adaption process was carried out successfully. Few linguistic challenges were identified and resolved by the expert review. The findings of the pre-testing indicated high acceptability and usability of the adapted CPS among 152 Danish patients and parents. The collaborative role emerged as the most preferred across settings (69.8%), with passive roles more prevalent among cancer patients (30%) and parents waiting with their child to see a pediatrician (23.3%). Notable, more women preferred collaborative or active roles (83.9%) than men (73.9%). The content validity assessment yielded positive feedback, affirming the relevance and comprehensiveness of the CPS.

Conclusions: In summary, the adaptation and validation of the CPS for Danish use proved successful, providing a valuable tool for assessing patient's role preferences in healthcare decision-making. However, future studies are recommended to ensure construct validity and reliability through psychometric testing.