Journal of Patient-Reported Outcomes最新文献

{"title":"Characteristics of longitudinal changes in quality of life and associated factors in patients post cardiac and thoracic aortic surgery: insights from a prospective cohort study.","authors":"Masaaki Sato, Hitoshi Mutai, Shuhei Yamamoto, Daichi Tsukakoshi, Keisuke Furuhashi, Hajime Ichimura, Yuko Wada, Tatsuichiro Seto, Hiroshi Horiuchi","doi":"10.1186/s41687-024-00787-9","DOIUrl":"https://doi.org/10.1186/s41687-024-00787-9","url":null,"abstract":"<p><strong>Background: </strong>Although quality of life (QOL) is an outcome of postoperative cardiac rehabilitation (CR), its course and related factors from postoperative hospitalization to the post-discharge period have not been adequately investigated. Additionally, the EuroQol-5Dimension-5Level (EQ-5D-5L) index score has not been characterized over the same period. We aimed to characterize QOL changes assessed by the EQ-5D-5L, over the period from hospitalization to 1 year post-discharge, in patients post-cardiac and thoracic aortic surgery, and investigate the factors associated with these temporal changes.</p><p><strong>Methodology: </strong>This prospective, single-center study included 117 patients who underwent open cardiovascular surgery (median age, 72 years; men, 69%). Patients were assessed for QOL status when transferred to the general ward; at discharge; and at 6 and 12 months after discharge, using the EQ-5D-5L index score and a generalized linear mixed model with random intercepts. Patients were classified into two groups based on score changes post-discharge. Logistic regression analysis evaluated factors associated with QOL decrease post-discharge.</p><p><strong>Results: </strong>The EQ-5D-5L index score significantly increased over time, except between 6 and 12 months post-discharge; \"Common activities\" was the most common dimension showing score improvement. In 25 patients (21%), the EQ-5D-5L index scores were lower after discharge compared to their scores at discharge. In the logistic regression analysis, Barthel Index pre-admission, preoperative hemoglobin level, and Mini-Mental State Examination-Japanese scores pre-discharge were significantly associated with QOL decline after adjusting for the European System for Cardiac Operative Risk Evaluation II score.</p><p><strong>Conclusions: </strong>Most patients post-cardiac or thoracic aortic surgery experienced improved QOL from postoperative hospital stay to 1 year post-discharge. However, in patients with pre-operative basic activities of daily living, hemoglobin and post-operative cognitive decline may require ongoing comprehensive CR because of reduced QOL. Given the potential selection bias introduced by the relatively small sample size in this study, future research involving larger populations is necessary.</p>","PeriodicalId":36660,"journal":{"name":"Journal of Patient-Reported Outcomes","volume":null,"pages":null},"PeriodicalIF":2.4,"publicationDate":"2024-09-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11427642/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142355768","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The psychometric properties of the Quality of Life in Neurological Disorders (Neuro-QoL) measurement system in neurorehabilitation populations: a systematic review","authors":"Rebecca Ataman, Rehab Alhasani, Line Auneau-Enjalbert, Adria Quigley, Henry Ukachukwu Michael, Sara Ahmed","doi":"10.1186/s41687-024-00743-7","DOIUrl":"https://doi.org/10.1186/s41687-024-00743-7","url":null,"abstract":"To systematically review the literature of existing evidence on the measurement properties of the Quality of Life in Neurological Disorders (Neuro-QoL) measurement system among neurorehabilitation populations. The Consensus-based Standards for the selection of health Measurement Instruments (COSMIN) guided this systematic review in which we searched nine electronic databases and registries, and hand-searched reference lists of included articles. Two independent reviewers screened selected articles and extracted data from 28 included studies. COSMIN’s approach guided extraction and synthesizing measurement properties evidence (insufficient, sufficient), and the modified GRADE approach guided synthesizing evidence quality (very-low, low, moderate, high) by diagnosis. Neuro-QoL has sufficient measurement properties when used by individuals with Huntington’s disease, Multiple Sclerosis, Parkinson’s disease, stroke, lupus, cognitive decline, and amyotrophic lateral sclerosis. The strongest evidence is for the first four conditions, where test-retest reliability, construct validity, and responsiveness are nearly always sufficient (GRADE: moderate-high). Structural validity is assessed only in multiple sclerosis and stroke but is often insufficient (GRADE: moderate-high). Criterion validity is sufficient in some stroke and Huntington’s disease domains (GRADE: high). Item response theory analyses were reported for some stroke domains only. There is limited, mixed evidence for responsiveness and measurement error (GRADE: moderate-high), and no cross-cultural validity evidence Neuro-QoL domains can describe and evaluate patients with Huntington’s disease, multiple sclerosis, Parkinson’s disease, and stroke, but predictive validity evidence would be beneficial. In the other conditions captured in this review, a limited number of Neuro-QoL domains have evidence for descriptive use only. For these conditions, further evidence of structural validity, measurement error, cross-cultural validity and predictive validity would enhance the use and interpretation of Neuro-QoL.","PeriodicalId":36660,"journal":{"name":"Journal of Patient-Reported Outcomes","volume":null,"pages":null},"PeriodicalIF":2.7,"publicationDate":"2024-09-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142262399","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Health-related quality of life among women diagnosed with in situ or invasive breast cancer and age-matched controls: a population-based study","authors":"Synne K. H. Bøhn, Karianne Svendsen, A. Balto, Ylva Maria Gjelsvik, Tor Åge Myklebust, Elin Børøsund, Hege R. Eriksen, A. Meland, K. Østby, L. Solberg Nes, Cecilie E. Kiserud, Kristin V. Reinertsen, G. Ursin","doi":"10.1186/s41687-024-00781-1","DOIUrl":"https://doi.org/10.1186/s41687-024-00781-1","url":null,"abstract":"A breast cancer (BC) diagnosis may negatively affect health-related quality of life (HRQoL). However, there are few comparisons of HRQoL at several time points for women with BC, and particular when subdivided into invasive and in situ tumors. The purpose of this study was to investigate various aspects of HRQoL in women recently diagnosed with invasive BC or ductal carcinoma in situ (in situ) compared to age-matched BC free controls in a population-wide sample recruited through the Cancer Registry of Norway. This cross-sectional study utilized HRQoL data collected in 2020–2022 from a digital survey including 4117 cases (3867 women with invasive BC and 430 with in situ) and 2911 controls. HRQoL was assessed ≥ 21 days after diagnosis, using EORTC QLQ-C30. This includes scores assessing global quality of life (gHRQoL) and HRQoL functions and symptoms. Multivariable regression analyses were used to compare HRQoL between cases and controls and to identify factors associated with gHRQoL and fatigue. Additionally, HRQoL 14 months after diagnosis was analyzed in 1989 of the included cases and in 1212 of the controls. Score differences of ≥ 10 points were considered clinically relevant and thus presented in the results. Invasive BC cases had lower gHRQoL, role- and social functioning in addition to more fatigue than controls. In situ cases had lower role—and social functioning than controls. Invasive BC cases scored worse than in situ on all domains, but the differences were not considered clinically relevant. Physical activity was associated with better gHRQoL and less fatigue in invasive BC, in situ and controls. Both invasive BC and in situ cases improved their role- and social functioning scores from diagnosis to 14 months follow-up, however no improvement was seen for fatigue. Women with invasive BC and in situ reported lower role- and social functioning scores than controls right after diagnosis with improvements 14 months after diagnosis. Physical activity was associated with better gHRQoL and less fatigue and should, whenever possible, play a key role in the care for BC patients.","PeriodicalId":36660,"journal":{"name":"Journal of Patient-Reported Outcomes","volume":null,"pages":null},"PeriodicalIF":2.7,"publicationDate":"2024-09-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142269781","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Cross-cultural adaptation and psychometric validation of the Chichewa (Malawi) PedsQL™ 4.0 Generic Core Scales child self-report and PedsQL™ 4.0 GCS teen self-report","authors":"Lucky Gift Ngwira, Hendramoorthy Maheswaran, Stavros Petrou, Louis W. Niessen, Sarah C. Smith","doi":"10.1186/s41687-024-00761-5","DOIUrl":"https://doi.org/10.1186/s41687-024-00761-5","url":null,"abstract":"The PedsQL™ 4.0 Generic Core Scales (GSC) have been translated into over 60 languages, but use in the sub-Saharan African region is limited. This study aimed to cross-culturally adapt and validate the PedsQL™ 4.0 GCS child self-report and teen self-report versions into the Chichewa language for Malawi. The English (USA) versions were adapted (translation, back translation and cognitive interviews to evaluate conceptual equivalence) into Chichewa. We recruited 289 children (8–17 years) in Blantyre, Malawi. Classical psychometrics at the item level (missing data, endorsement frequencies, item redundancy) and scale level (internal consistency, convergent, discriminant and known groups validity) was used to evaluate the new Chichewa versions. Six items were found to need cultural adaptation for Malawi. There were problems with missing data (< 5%) and adjacent endorsement frequency (< 10%) among younger children. Internal consistency reliability was acceptable (Cronbach α > 0.7). Convergent validity was generally strong (correlations > 0.4). Discriminant validity (p > 0.05) was evident with respect to gender and age, but not for school grade (p < 0.05). Effect sizes indicating known groups validity were in the expected direction but of variable magnitude. We have successfully adapted the PedsQL™ 4.0 GCS child self-report and teen self-report into Chichewa for use in Malawi. Many aspects of the psychometric evaluation were promising, though some elements were more mixed and we have not yet been able to evaluate test-retest reliability or responsiveness. We suggest that the PedsQL™4.0 GCS child and teen self-reports should be used with caution among children and adolescents in Malawi.","PeriodicalId":36660,"journal":{"name":"Journal of Patient-Reported Outcomes","volume":null,"pages":null},"PeriodicalIF":2.7,"publicationDate":"2024-09-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142209934","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Reliability and validity of the German version of the University of Jyvaskyla Active Aging Scale (UJACAS-G)","authors":"Timo Hinrichs, Taina Rantanen, Erja Portegijs, Lukas Nebiker, Roland Rössler, Fabian Schwendinger, Arno Schmidt-Trucksäss, Ralf Roth","doi":"10.1186/s41687-024-00786-w","DOIUrl":"https://doi.org/10.1186/s41687-024-00786-w","url":null,"abstract":"The University of Jyvaskyla Active Aging Scale (UJACAS) assesses active aging through willingness, ability, opportunity, and frequency of involvement in activities. Recognizing the lack of a German version, the Finnish original was translated (UJACAS-G). This study aimed: (1) to evaluate the test-retest reliability of UJACAS-G; and (2) to explore correlations with health-related parameters (concurrent validity). The study (test-retest design) targeted healthy older adults aged 65+. Reliability of UJACAS-G (total and subscores) was assessed using Bland-Altman analyses and Intraclass Correlation Coefficients (ICCs). Furthermore, correlations (Spearman’s rho) between UJACAS-G scores and physical function (walking speed, handgrip strength, balance, 6-minute walk distance), physical activity (International Physical Activity Questionnaire), life-space mobility (Life-Space Assessment), and health-related quality of life (Short Form-36 Health Survey) were calculated. Bland-Altman analyses (N = 60; mean age 72.3, SD 5.9 years; 50% women) revealed mean differences close to zero and narrow limits of agreement for all scores (total score: mean difference −1.9; limits −31.7 to 27.9). The ability subscore showed clustering at its upper limit. ICC was 0.829 (95% CI 0.730 to 0.894) for the total score and ranged between 0.530 and 0.876 for subscores (all p-values < 0.001). The total score correlated with walking speed (rho = 0.345; p = 0.008), physical activity (rho = 0.279; p = 0.033) and mental health (rho = 0.329; p = 0.010). UJACAS-G is reliable for assessing active aging among German-speaking healthy older adults. A potential ‘ceiling effect’ regarding the ability subscore should be considered when applying UJACAS-G to well-functioning populations. Analyses of concurrent validity indicated only weak correlations with health-related parameters.","PeriodicalId":36660,"journal":{"name":"Journal of Patient-Reported Outcomes","volume":null,"pages":null},"PeriodicalIF":2.7,"publicationDate":"2024-09-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142209951","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"APPROACH e-PROM system: a user-centered development and evaluation of an electronic patient-reported outcomes measurement system for management of coronary artery disease.","authors":"Andrew Roberts, Eleanor Benterud, Maria J Santana, Jordan Engbers, Christine Lorenz, Nancy Verdin, Winnie Pearson, Peter Edgar, Joel Adekanye, Pantea Javaheri, Courtney E MacDonald, Sarah Simmons, Sandra Zelinsky, Jeff Caird, Rick Sawatzky, Bryan Har, William A Ghali, Colleen M Norris, Michelle M Graham, Matthew T James, Stephen B Wilton, Tolulope T Sajobi","doi":"10.1186/s41687-024-00779-9","DOIUrl":"10.1186/s41687-024-00779-9","url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":36660,"journal":{"name":"Journal of Patient-Reported Outcomes","volume":null,"pages":null},"PeriodicalIF":2.4,"publicationDate":"2024-08-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11358368/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142082065","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A review of Patient Reported Outcome Measures (PROMs) for characterizing Long COVID (LC)-merits, gaps, and recommendations.","authors":"Hammed Ejalonibu, Adelaide Amah, Alaa Aburub, Pawan Kumar, D E Frederick, Gary Groot","doi":"10.1186/s41687-024-00773-1","DOIUrl":"10.1186/s41687-024-00773-1","url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":36660,"journal":{"name":"Journal of Patient-Reported Outcomes","volume":null,"pages":null},"PeriodicalIF":2.4,"publicationDate":"2024-08-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11347522/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142056785","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The impact of the COVID-19 pandemic on health-related quality of life of cancer patients in British Columbia.","authors":"Sara Izadi-Najafabadi, Helen McTaggart-Cowan, Ross Halperin, Leah Lambert, Craig Mitton, Stuart Peacock","doi":"10.1186/s41687-024-00759-z","DOIUrl":"10.1186/s41687-024-00759-z","url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Method: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":36660,"journal":{"name":"Journal of Patient-Reported Outcomes","volume":null,"pages":null},"PeriodicalIF":2.4,"publicationDate":"2024-08-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11343924/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142037282","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Development of a new patient-reported outcome measure for complex cryptoglandular fistulas (20-Item complex cryptoglandular fistula questionnaire^™): a qualitative study.","authors":"Jeffrey D McCurdy, Patrick Crooks, Chad Gwaltney, Robert Krupnick, Kathy-Ann Cadogan, Chitra Karki","doi":"10.1186/s41687-024-00729-5","DOIUrl":"10.1186/s41687-024-00729-5","url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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^™).</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":36660,"journal":{"name":"Journal of Patient-Reported Outcomes","volume":null,"pages":null},"PeriodicalIF":2.4,"publicationDate":"2024-08-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11341802/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142019041","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The development of a new oral health patient reported outcome measure: the New South Wales public dental services approach.","authors":"Rebecca Chen, Shilpi Ajwani, Bradley Christian, Claire Phelan, Ravi Srinivas, Josephine Kenny, Mark O'Connor, Kara Clarke, Woosung Sohn, Albert Yaacoub","doi":"10.1186/s41687-024-00777-x","DOIUrl":"10.1186/s41687-024-00777-x","url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":36660,"journal":{"name":"Journal of Patient-Reported Outcomes","volume":null,"pages":null},"PeriodicalIF":2.4,"publicationDate":"2024-08-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11333637/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142000885","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}