Journal of Patient-Reported Outcomes最新文献

{"title":"The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) scale in patients with axial spondyloarthritis: psychometric properties and clinically meaningful thresholds for interpretation.","authors":"David Cella, Christine de la Loge, Fatoumata Fofana, Shien Guo, Alicia Ellis, Carmen Fleurinck, Ute Massow, Maxime Dougados, Victoria Navarro-Compán, Jessica A Walsh","doi":"10.1186/s41687-024-00769-x","DOIUrl":"10.1186/s41687-024-00769-x","url":null,"abstract":"<p><strong>Background: </strong>Fatigue is an important symptom for most patients with axial spondyloarthritis (axSpA). The FACIT-Fatigue is a 13-item patient-reported outcome (PRO) instrument that has been used in axSpA clinical trials to measure fatigue severity and impact on daily activities. However, the psychometric properties of the FACIT-Fatigue are not fully evaluated across the entire spectrum of axSpA including non-radiographic axSpA (nr-axSpA) and radiographic axSpA (r-axSpA). This study determined: (1) the psychometric properties of the FACIT-Fatigue in nr-axSpA, r-axSpA, and the broad axSpA population and (2) FACIT-Fatigue scores representing meaningful within-patient change (MWPC), meaningful between-group differences, and cross-sectional severity bands.</p><p><strong>Methods: </strong>Data from two Phase 3 trials in adults with nr-axSpA (BE MOBILE 1; N = 254) and r-axSpA (BE MOBILE 2; N = 332) were analyzed pooled and separately to assess the psychometric properties of the FACIT-Fatigue. MWPC and meaningful between-group difference estimates were derived using anchor-based and distribution-based methods. Cross-sectional fatigue severity bands were estimated using logistic regression analysis.</p><p><strong>Results: </strong>The FACIT-Fatigue presented good internal consistency, adequate convergent and known-groups validity, and was sensitive to change over time across the full axSpA spectrum. A 5-11-point increase in FACIT-Fatigue score was estimated to represent a MWPC, with an 8-point increase selected as the responder definition. A 2.14-5.34-point difference in FACIT-Fatigue score change over a 16-week period was estimated to represent a small-to-medium meaningful between-group difference. FACIT-Fatigue score severity bands were defined as: none or minimal (>40), mild (>30 to ≤40), moderate (>21 to ≤30), and severe (≤21).</p><p><strong>Conclusions: </strong>These findings support the use of the FACIT-Fatigue as a fit-for-purpose measure to assess fatigue-related treatment benefit in axSpA clinical trials. The proposed score estimates and thresholds can guide FACIT-Fatigue score interpretation across the full axSpA spectrum.</p><p><strong>Trial registration: </strong>ClinicalTrials.Gov, NCT03928704. Registered 26 April 2019-Retrospectively registered, https://classic.</p><p><strong>Clinicaltrials: </strong>gov/ct2/show/NCT03928704 .</p><p><strong>Clinicaltrials: </strong>Gov, NCT03928743. Registered 26 April 2019-Retrospectively registered, https://classic.</p><p><strong>Clinicaltrials: </strong>gov/ct2/show/NCT03928743 .</p>","PeriodicalId":36660,"journal":{"name":"Journal of Patient-Reported Outcomes","volume":"8 1","pages":"92"},"PeriodicalIF":2.4,"publicationDate":"2024-08-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11319684/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141917608","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 symptoms evolution of long COVID‑19 (SE-LC19): a new patient-reported content valid instrument.","authors":"Diana Rofail, Selin Somersan-Karakaya, Eleftherios Mylonakis, Julia Y Choi, Krystian Przydzial, Sarah Marquis, Yuming Zhao, Mohamed Hussein, Thomas D Norton, Anna J Podolanczuk, Gregory P Geba","doi":"10.1186/s41687-024-00737-5","DOIUrl":"10.1186/s41687-024-00737-5","url":null,"abstract":"<p><strong>Background: </strong>The field of long COVID research is rapidly evolving, however, tools to assess and monitor symptoms and recovery of the disease are limited. The objective of the present study was to develop a new patient-reported outcomes instrument, the Symptoms Evolution of Long COVID‑19 (SE-LC19), and establish its content validity.</p><p><strong>Methods: </strong>The 40-item SE-LC19 instrument was developed based on patient-relevant empirical evidence from scientific literature and clinical guidelines that reported symptoms specific to long COVID. A 2-part mixed-method approach was employed. Part 1: Qualitative interviews with a purposive sample of 41 patients with confirmed long COVID were conducted for the content validation of SE-LC19. During cognitive debriefing interviews, patients were asked to describe their understanding of the instrument's instructions, specific symptoms, response options, and recall period to ensure its relevance and comprehensiveness. Five clinicians of different medical specialties who regularly treated patients with long COVID were also interviewed to obtain their clinical expert opinions on SE-LC19. Part 2: Exploratory Rasch Measurement Theory (RMT) analysis was conducted to evaluate the psychometric properties of the SE-LC19 data collected during the interviews.</p><p><strong>Results: </strong>Overall, patients reported that the instructions, questions, recall period, and response options for SE-LC19 were comprehensive and relevant. Minor conceptual gaps reported by patients captured nuances in the experience of some symptoms that could be considered in future studies. Some patients suggested a revision of the recall period from 24 h to 7 days to be able to capture more symptoms given the waxing and waning nature of some symptoms. Clinicians found the instrument comprehensive with minimal suggestions regarding its content. Exploratory RMT analyses provided evidence that the SE-LC19 questionnaire performed as intended.</p><p><strong>Conclusion: </strong>The present mixed-methods study in patients with confirmed long COVID supports the content validity and applicability of the SE-LC19 instrument to evaluate the symptoms of patients with long COVID. Further research is warranted to explore the psychometric properties of the instrument and refine a meaningful and robust patient-relevant endpoint for use in different settings such as clinical trials and clinical practice to track the onset, severity, and recovery of long COVID.</p>","PeriodicalId":36660,"journal":{"name":"Journal of Patient-Reported Outcomes","volume":"8 1","pages":"87"},"PeriodicalIF":2.4,"publicationDate":"2024-08-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11310370/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141907898","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":"Agreement between child self-report and parent-proxy report for functioning in pediatric chronic pain.","authors":"Joan W Hanania, Jessica Edwards George, Christie Rizzo, Justin Manjourides, Laura Goldstein","doi":"10.1186/s41687-024-00774-0","DOIUrl":"10.1186/s41687-024-00774-0","url":null,"abstract":"<p><strong>Purpose: </strong>Accurate assessment of chronic pain and functional disability in children and adolescents is imperative for guiding pain management interventions. Parents have multifaceted roles in their child's pain experience and frequently provide parent-proxy reports of pain-related functioning. However, cross-informant variance is often observed with limited understanding of contributing factors. This study aims to examine the degree of alignment between child and parent-proxy reports for Patient-Reported Outcomes Measurement Information System (PROMIS) pain interference domain among children with chronic pain and to identify factors associated with improved child-parent agreement.</p><p><strong>Methods: </strong>This study includes a sample of 127 youth (66.1% female) with mixed etiology chronic pain, ranging in age from 8 to 17 (M = 12.24; SD = 1.598), and their parent. Data was collected at an interdisciplinary pediatric pain clinic and online peer support groups. Measures of demographic, pain intensity, and functioning were collected.</p><p><strong>Results: </strong>Means of parent-proxy reports were significantly lower than child self-reports on the PROMIS (p < 0.05). A statistically significant association between child's pain intensity (β = 0.953, P < 0.05) and the difference between child self-reported and parent-proxy reported PROMIS functional interference scores was found.</p><p><strong>Conclusion: </strong>Parents underestimated pain-related functional disability relative to children's self-reports. The difference between the paired child self-report and parent-proxy report of functional disability was significantly associated with greater child self-reported pain intensity. Although parent-proxy reports in pediatric chronic pain is often used in research and practice, findings underscore the importance of incorporating child and adolescent self-report, when possible, to comprehensively capture the child's pain experience and best inform clinical interventions.</p>","PeriodicalId":36660,"journal":{"name":"Journal of Patient-Reported Outcomes","volume":"8 1","pages":"88"},"PeriodicalIF":2.4,"publicationDate":"2024-08-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11315847/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141907897","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":"Psychometric properties and moderated mediation analysis of the ICIQ-NQOL in Chinese primary care patients with nocturia.","authors":"Edmond Pui Hang Choi, Chanchan Wu, Lily Man Lee Chan, Heidi Sze Lok Fan, Jojo Yan Yan Kwok, Pui Hing Chau, Esther Yee Tak Yu, Samuel Yeung Shan Wong, Cindy Lo Kuen Lam","doi":"10.1186/s41687-024-00756-2","DOIUrl":"10.1186/s41687-024-00756-2","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Many individuals consider nocturia a significant nuisance, leading to a reduced health-related quality of life (HRQOL). However, there has been a lack of psychometrically sound patient-reported outcome measures to assess the impact of nocturia on patients in Chinese contexts. This study aimed to translate, culturally adapt, and validate the International Consultation on Incontinence Questionnaire Nocturia Quality of Life Module (ICIQ-NQOL) for use among primary care patients in Hong Kong, China. Additionally, it sought to investigate the mechanisms that link nocturia and sleep quality with HRQOL by employing moderated mediation analysis.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;The traditional Chinese version of the ICIQ-NQOL was developed through iterative translations, cognitive debriefing interviews, and panel reviews. The psychometric evaluation included assessments of factor structure, convergent validity, concurrent validity, known-group validity, internal consistency, test-retest reliability and responsiveness. Study instruments included the ICIQ-NQOL, International Prostate Symptom Score (IPSS), Pittsburgh Sleep Quality Index (PSQI), and a modified Incontinence Impact Questionnaire-Short Form (IIQ-7).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;A total of 419 primary care patients were recruited from general outpatient clinics, among whom 228 experiencing an average of two or more nocturia episodes per night over the past four weeks. Confirmatory factor analysis supported the two-factor structure of the ICIQ-NQOL. Concurrent validity was confirmed by moderate correlations between the IIQ-7 total score and the total score as well as two domain scores of the ICIQ-NQOL (r ranging from 0.43 to 0.49, all p &lt; 0.001). The ICIQ-NQOL also had moderate correlations with the IPSS total symptom score (r ranging from 0.40 to 0.48, all p &lt; 0.001). Convergent validity was supported by moderate correlations between the global PSQI score and the total score as well as two domain scores of the ICIQ-NQOL (r ranging from 0.42 to 0.52, all p &lt; 0.001). Known-group comparisons showed that the ICIQ-NQOL could differentiate between patients with and without nocturia in terms of sleep/energy domain score (p &lt; 0.001), bother/concern domain score (p &lt; 0.001), and total score (p &lt; 0.001), each demonstrating a moderate Cohen's d effect size. Item-total correlations corrected for overlap exceeded 0.4, and Cronbach's alpha coefficients were greater than 0.7. Test-retest reliability was confirmed with intraclass correlation coefficients exceeding 0.7 among patients reporting no change in their nocturia symptoms at a 2-week follow-up. Regarding responsiveness, the Cohen's d effect sizes for differences in domain and total scores between the baseline and 2-week follow-up assessments were greater than 0.3 among patients showing improvement in nocturia. Our moderated mediation analysis indicated that sleep quality significantly moderated the impact of nocturia on ","PeriodicalId":36660,"journal":{"name":"Journal of Patient-Reported Outcomes","volume":"8 1","pages":"86"},"PeriodicalIF":2.4,"publicationDate":"2024-08-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11306455/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141898491","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":"Correction: Responsiveness of the patient-specific Canadian occupational performance measure and a fixed-items activity limitations measure in patients with dupuytren disease.","authors":"Anna Lauritzson, David Eckerdal, Isam Atroshi","doi":"10.1186/s41687-024-00768-y","DOIUrl":"10.1186/s41687-024-00768-y","url":null,"abstract":"","PeriodicalId":36660,"journal":{"name":"Journal of Patient-Reported Outcomes","volume":"8 1","pages":"85"},"PeriodicalIF":2.4,"publicationDate":"2024-08-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11303604/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141894521","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":"Can items derived from international literature be used in national quality of life instruments? A qualitative study conceptualising the EQ-HWB in China.","authors":"Guangjie Zhang, Zhihao Yang, Nan Luo, Pei Wang, Jan Busschbach","doi":"10.1186/s41687-024-00767-z","DOIUrl":"10.1186/s41687-024-00767-z","url":null,"abstract":"<p><strong>Introduction: </strong>The EQ Health and Wellbeing (EQ-HWB) is a new questionnaire for measuring quality of life (QoL) from a broad perspective. The items of the EQ-HWB were derived based on a 'qualitative review' of literature, which reported primarily on Western studies. It can be argued that the QoL is a cultural-related concept and therefore people from China have a different understanding of the QoL. This study aimed to explore whether Chinese citizens could understand the EQ-HWB's candidate items and what they thought of those items. In doing so, we wanted to examine the face validity of the candidate items and explore if further cultural adaptation is necessary.</p><p><strong>Methods: </strong>This research was part of the E-QALY project, in which 36 candidate items were selected for the EQ-HWB from a 97-item pool. In China, three interviewers investigated the face validity of these EQ-HWB candidate items in semi-structured qualitative face-to-face interviews. Respondents were invited to report 'problems' with regard to the interpretation of the items and these problems were grouped into themes. We explored to what extent those themes related to specific cultural aspects in China. We also classified the rates of reported problems for each item into three groups: 1) less than 20%, 2) from 20-50%, and 3) over 50%.</p><p><strong>Results: </strong>For 17 items the rate of reported problems was less than 20%, 15 items fell into the second group (with 20 - 50%) and for 4 items the rate of problems reported was more than 50%. The thematic analysis revealed eight themes: ambiguous problems in the interpretation of 16 items; difficult to understand (11); contained a complex negative expression (10); examples used seemed inappropriate (7); misleading connotation in Chinese (2); long and complex (2); complex response options (1); and use of non-colloquial language (1).</p><p><strong>Discussion: </strong>Our research shows that EQ-HWB candidate items require careful examination to make them more comprehensible. Most of the reported problem themes were generic problems related to the items, and only a few face validity issues appeared to relate to specific cultural aspects in China, even though most of the items were based on Western studies. Our findings are reassuring for the instrument's international application, especially in China.</p>","PeriodicalId":36660,"journal":{"name":"Journal of Patient-Reported Outcomes","volume":"8 1","pages":"83"},"PeriodicalIF":2.4,"publicationDate":"2024-08-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11300404/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141890318","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":"Relative contribution of comorbid diseases to health-related quality of life in patients with Parkinson's disease.","authors":"Maija-Helena Keränen, Laura Kytövuori, Juha Huhtakangas, Mikko Kärppä, Kari Majamaa","doi":"10.1186/s41687-024-00746-4","DOIUrl":"10.1186/s41687-024-00746-4","url":null,"abstract":"<p><strong>Background: </strong>Multimorbidity is common in elderly people, and one of the major consequences of multimorbidity is low health-related quality of life (HRQoL). The aim of this study was to investigate the frequency of comorbid diseases in patients with Parkinson's disease (PD) and to analyze their relative importance in HRQoL. The aim was also to examine agreement between the generic 15D questionnaire and the PD-specific Parkinson's Disease Questionnaire (PDQ-8) to further validate 15D in the evaluation of HRQoL in patients with PD.</p><p><strong>Methods: </strong>Patients with PD (N = 551) filled a questionnaire on comorbid diseases, and the 15D questionnaire yielding a 15-dimensional health profile and a score representing the overall HRQoL. Self-organizing map was used for an unsupervised pattern recognition of the health profiles. Relative importance analysis was used to evaluate the contribution of 16 comorbid diseases to the 15D score. The agreement between 15D and PDQ-8 questionnaires was studied in a subset of 81 patients that were examined clinically.</p><p><strong>Results: </strong>533 patients (96.7%) reported comorbid diseases. The most affected dimensions in the 15D questionnaire were secretion, usual activities, discomfort and symptoms, and sexual activity. Self-organizing map identified three patterns of health profiles that included patients with high, low or transition HRQoL. The transition subgroup was similar to low HRQoL subgroup in non-motor dimensions. Sixteen comorbid diseases explained 33.7% of the variance in the 15D score. Memory deficit, depression, heart failure, and atrial fibrillation had the highest relative importance. The intraclass correlation coefficient between the generic 15D and the PD-specific PDQ-8 was 0.642 suggesting moderate reliability.</p><p><strong>Conclusions: </strong>The most marked differences in HRQoL were in the dimensions of secretion, usual activities, and sexual activity. Pattern detection of 15D health dimensions enabled the detection of a subgroup with disproportionately poor HRQoL in non-motor dimensions. The comorbid diseases affecting most to HRQoL were memory deficit and depression. The generic 15D questionnaire can be used in the evaluation of HRQoL in PD patients.</p>","PeriodicalId":36660,"journal":{"name":"Journal of Patient-Reported Outcomes","volume":"8 1","pages":"84"},"PeriodicalIF":2.4,"publicationDate":"2024-08-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11300740/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141894522","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 Chinese version of patient experience with treatment and self-management (PETS vs. 2.0): translation and validation in patients with multimorbidity in primary care in Hong Kong.","authors":"Zijun Xu, Dexing Zhang, Yang Zhao, Arpita Ghosh, David Peiris, Yiqi Li, Samuel Yeung Shan Wong","doi":"10.1186/s41687-024-00765-1","DOIUrl":"10.1186/s41687-024-00765-1","url":null,"abstract":"<p><strong>Background: </strong>Validated and comprehensive tools to measure treatment burden are needed for healthcare professionals to understand the treatment burden of patients in China. The study aimed to translate and validate the Chinese version of Patient Experience with Treatment and Self-management (PETS vs. 2.0) in patients with multimorbidity in primary care.</p><p><strong>Methodology: </strong>The translation process of the 60-item PETS vs. 2.0 followed the Functional Assessment of Chronic Illness Therapy (FACIT) Translation, Formatting, and Testing Guidelines. Computer-assisted assessments were conducted in adult primary care patients with multimorbidity from three general out-patient clinics in Hong Kong. A sample of 502 patients completed the assessments from July to December 2023. Internal reliability was examined using Cronbach's alphas for each domain of the PETS vs. 2.0. Concurrent validity was assessed through the correlations between different domains of PETS vs. 2.0 with established measures including quality of life, frailty, and depression. Confirmatory Factor Analysis (CFA) with maximum likelihood method was carried out to assess the construct validity.</p><p><strong>Results: </strong>The mean age of participants was 64.9 years old and 56.2% were female. Internal consistency reliability was acceptable (alpha ≥ 0.70) for most domains. Higher scores of PETS domains were significantly correlated with worse quality of life, higher level of frailty, and more depressive symptoms (p < 0.05). In CFA, after setting the covariances on the error variances, the adjusted model revealed an acceptable model fit (χ²/df = 1.741; root mean square error of approximation (RMSEA) = 0.038; standardized root mean square residual (SRMR) = 0.058; comparative fit index (CFI) = 0.911; Tucker-Lewis Index (TLI) = 0.903). All standardized factor loadings were 0.30 or above. Significant positive correlations between the latent factors were found for all factor pairs (correlation coefficient < 0.8).</p><p><strong>Conclusions: </strong>The Chinese version of PETS vs. 2.0 is a reliable and valid tool for assessing the perceived treatment burden in patients with multimorbidity in primary care. All domains and items in the original questionnaires were retained.</p>","PeriodicalId":36660,"journal":{"name":"Journal of Patient-Reported Outcomes","volume":"8 1","pages":"82"},"PeriodicalIF":2.4,"publicationDate":"2024-08-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11297226/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141876246","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":"Developing the EPI Symptom Questionnaire (EPI-SQ): a qualitative study to understand the symptom experience of patients with exocrine pancreatic insufficiency (EPI).","authors":"Sally Mannix, Amit Bodhani, Leah Kleinman, Nikhil Khandelwal, Vikesh K Singh","doi":"10.1186/s41687-024-00760-6","DOIUrl":"10.1186/s41687-024-00760-6","url":null,"abstract":"<p><strong>Background: </strong>Symptom assessment is the key factor in determining disease status and optimal management of exocrine pancreatic insufficiency (EPI). There is a need for a standardized patient-reported outcome (PRO) questionnaire to assess symptoms in patients diagnosed with EPI. The purpose of this qualitative study was to increase understanding of the EPI symptom experience from the patients' perspective, and to develop and evaluate the content validity of the EPI Symptom Questionnaire (EPI-SQ) in US patients with EPI.</p><p><strong>Methods: </strong>Concept elicitation interviews (Phase I) were conducted to understand the symptom experience in patients with a clinical diagnosis of EPI (i.e., fecal pancreatic elastase value of ≤ 200 mcg/g based on most recent value) due to chronic pancreatitis or pancreatectomy. The EPI-SQ was developed based on the data extracted from Phase I interviews and feedback from clinical experts. Next, separate cognitive interviews (Phase II) were conducted to evaluate participants' understanding of the instructions, items, response scales, and recall periods of the instrument.</p><p><strong>Results: </strong>During Phase I interviews (n = 21), 19 participants (90%) reported abdominal pain as the most frequent EPI symptom and lifestyle changes were the most frequently endorsed impacts (n = 18; 86%). Phase II results indicated that all participants (n = 7) felt the 12-item EPI-SQ was relevant to their symptom experience and that they understood the items, instructions, and response options as intended.</p><p><strong>Conclusion: </strong>The qualitative data from this study support the content validity of the EPI-SQ in measuring EPI symptom severity in US patient populations diagnosed with EPI.</p>","PeriodicalId":36660,"journal":{"name":"Journal of Patient-Reported Outcomes","volume":"8 1","pages":"80"},"PeriodicalIF":2.4,"publicationDate":"2024-07-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11282023/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141767588","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":"Patient motivators of postoperative electronic patient-reported outcome symptom monitoring use in thoracic surgery patients: a qualitative study.","authors":"Meghan C O'Leary, Elizabeth Kwong, Chase Cox, Amanda L Gentry, Angela M Stover, Maihan B Vu, Jessica Carda-Auten, Jennifer Leeman, Gita N Mody","doi":"10.1186/s41687-024-00766-0","DOIUrl":"10.1186/s41687-024-00766-0","url":null,"abstract":"<p><strong>Background: </strong>Electronic patient-reported outcome (ePRO) systems can be used to engage patients in remote symptom monitoring to support postoperative care. We interviewed thoracic surgery patients with ePRO experience to identify factors that influenced use of ePROs to report their symptoms post-discharge.</p><p><strong>Method: </strong>This qualitative study used semi-structured telephone interviews with adults who underwent major thoracic surgery at an academic medical center in North Carolina. Individuals who enrolled in symptom monitoring, completed at least one ePRO survey, and were reachable by phone for the interview were included. The ePRO surveys assessed 10 symptoms, including validated Patient-Reported Outcome Common Terminology Criteria for Adverse Events (PRO-CTCAE) measures and thoracic surgery-specific questions. Surveys, offered via web-based and automated telephone options, were administered for four weeks post-discharge with alerts sent to clinicians for concerning symptoms. The interviews were guided by the Capability, Opportunity, Motivation model for behavior change (COM-B) and examined factors that influenced patients' completion of ePRO surveys post-discharge. Team members independently coded interviews and identified themes, informed by COM-B. We report descriptive statistics (demographics, number of surveys completed) and themes organized by COM-B components.</p><p><strong>Results: </strong>Of 28 patients invited, 25 (89%) completed interviews from July to October 2022. Participants were a median 58 years, 56% female, 80% White, and 56% had a history of malignancy. They completed 131/150 (87%) possible ePRO surveys. For capability, participants reported building ePROs into their routine and having the skills and knowledge, but lacking physical and emotional energy, to complete ePROs. For opportunity, participants identified the ease and convenience of accessing ePROs and providers' validation of ePROs. Motivators were perceived benefits of a deepening connection to their clinical team, improved symptom management for themselves and others, and self-reflection about their recovery. Factors limiting motivation included lack of clarity about the purpose of ePROs and a disconnect between symptom items and individual recovery experience.</p><p><strong>Conclusions: </strong>Patients described being motivated to complete ePROs when reinforced by clinicians and considered ePROs as valuable to their post-discharge experience. Future work should enhance ePRO patient education, improve provider alerts and communications about ePROs, and integrate options to capture patients' complex health journeys.</p>","PeriodicalId":36660,"journal":{"name":"Journal of Patient-Reported Outcomes","volume":"8 1","pages":"81"},"PeriodicalIF":2.4,"publicationDate":"2024-07-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11282008/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141767589","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}