Patient Related Outcome Measures最新文献

{"title":"Deriving Health Utilities from the Food Allergy Quality of Life Questionnaire - Parent Form (FAQLQ-PF) Using Mapping and Discrete Choice Experiments.","authors":"Adam B Smith, Tom Bromilow, Stuart Mealing, Charlotte Graham, Damian Lewis, Frederic Girard, Audrey DunnGalvin","doi":"10.2147/PROM.S571549","DOIUrl":"https://doi.org/10.2147/PROM.S571549","url":null,"abstract":"<p><strong>Purpose: </strong>Health-related quality of life (HRQoL) measures in the form of health utilities are valuable for economic evaluations of the effectiveness of food allergy interventions. However, traditional HRQoL instruments lack the sensitivity to generate health utilities that capture the impact that food allergies, such as peanut allergies, may have on children's mental health and daily activities. This study used mapping and discrete choice experiment (DCE) methods to generate health utilities from the Food Allergy Quality of life Questionnaire-Parent Form (FAQLQ-PF), which were then applied to clinical trial data.</p><p><strong>Patients and methods: </strong>Health utilities (HU) were generated using two methods: mapping and DCE. Parents of children with peanut allergies (N=159) completed the FAQLQ-PF and EQ-5D-Y-Proxy-1 questionnaires. Mapping algorithms were developed once the FAQLQ-PF responses were mapped onto the EQ-5D-3L utilities. A composite DCE with time trade-off and a vignette was conducted among parents without peanut allergic children (N=767). The utilities derived from the mapping and DCE methods were applied to clinical trial data (PEPITES and PEOPLE) for an epicutaneous peanut patch (DBV712).</p><p><strong>Results: </strong>The mapping algorithm showed an association of 0.199 between FAQLQ-PF and EQ-5D-3L utilities. The DCE disutilities were highest for severe food-related anxiety, emotional distress, and social limitations. Once applied to the clinical trial data, the HU derived from the mapping algorithm demonstrated statistically significant HRQoL improvements for the intervention group at 36 months. Using the DCE-derived utilities, statistically significant HRQoL improvements for the intervention group were demonstrated at both 24- and 36-months. The effect size analysis demonstrated that the DCE-derived utilities were more responsive than mapped utilities.</p><p><strong>Conclusion: </strong>DCE-derived utilities demonstrated greater responsiveness to changes in HRQoL compared with mapped utilities, suggesting their potential use in economic evaluations and HTA submissions for peanut allergy interventions. The DCE-derived health utilities showed greater sensitivity to changes in HRQoL. These utilities can be used in health technology assessments to better capture the impact of peanut allergy treatments on children's quality of life.</p>","PeriodicalId":19747,"journal":{"name":"Patient Related Outcome Measures","volume":"16 ","pages":"571549"},"PeriodicalIF":1.8,"publicationDate":"2026-04-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13118655/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147778019","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 Validation of the Speed of Change in Feeling of Health (SCFH) Questionnaire: Findings from the NEWTON Sub-Study in Italian Asthma Patients.","authors":"Ilaria Baiardini, Cristiano Caruso, Walter Castellani, Alberto Ricci, Lucio Michieletto, Cecilia Calabrese, Eleonora Ingrassia, Alessio Piraino, Lucia Simoni, Alessandra Ori, Fulvio Braido","doi":"10.2147/PROM.S543501","DOIUrl":"https://doi.org/10.2147/PROM.S543501","url":null,"abstract":"<p><strong>Purpose: </strong>Speed of clinical response to a new therapeutic intervention is a critical determinant of the overall treatment outcomes, but tools focused on asthma response speed are currently unavailable. This study aimed to validate the psychometric properties of a new questionnaire initially written in Italian, the Speed of Change in Feeling of Health (SCFH), in patients with asthma.</p><p><strong>Patients and methods: </strong>Two hundred and seventy subjects with not-well- or poorly controlled asthma, enrolled in the Italian sites of the NEWTON real-world study, were asked to complete the provisional version of SCFH and three validated questionnaires, the Stanford Expectation of Treatment Scale (SETS), the 5-item version of the Asthma Control Questionnaire (ACQ-5), and the Global Rating Scale (GRS). Internal consistency and validity were determined. Moreover, we assessed the minimal clinically important difference (MCID) using anchor-based method.</p><p><strong>Results: </strong>One hundred and ninety-six patients completed the questionnaire at least once at 7 (±1), 14 (±2), or 30 (±3) days after starting BDP/FF NEXThaler^® 100/6 μg treatment. We started from SCFH provisional questionnaire of 30 items, the internal consistency of which revealed a high redundancy (Cronbach's alpha of 0.98), prompting its reduction to an 8-item questionnaire (SCFH-8; Cronbach's alpha = 0.90). Known-group validity indicated significant differences in SCFH-8 scores (p = 0.0003) at 30 (±3) days after enrollment between improved and non-improved subjects, as defined by changes in ACQ-5 scores. The study confirmed the convergent validity through comparisons with the SETS and the ACQ-5 questionnaires. A clinically relevant change in feeling of health was observed in 43.3% of participants at 7 days, while the cumulative frequency of patients reporting a clinically relevant change in their feeling of health at 30 days after enrollment was 70.4%.</p><p><strong>Conclusion: </strong>The Italian version of SCFH-8 is a valid, short tool with good psychometric properties for determining the speed of change in health perception after starting treatment.</p>","PeriodicalId":19747,"journal":{"name":"Patient Related Outcome Measures","volume":"16 ","pages":"543501"},"PeriodicalIF":1.8,"publicationDate":"2026-04-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13118647/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147777962","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 Evaluation of the Hypoparathyroidism Symptom Diary: Data from a Prospective Phase 3b/4 Study.","authors":"Suwei Wang, Nicholas J Rockwood, Stuart Yarr, Dane Korver, Felicia Castriota, Susan Martin, Olulade Ayodele","doi":"10.2147/PROM.S539994","DOIUrl":"https://doi.org/10.2147/PROM.S539994","url":null,"abstract":"<p><strong>Purpose: </strong>To assess the psychometric properties of the disease-specific Hypoparathyroidism Symptom Diary (HypoPT-SD) patient-reported outcome (PRO) tool, which consists of a 7-item symptom subscale, a 4-item impact subscale, a single item for anxiety, and a single item for sadness or depression, using data from the BALANCE randomized, placebo-controlled Phase 3b/4 study (NCT03324880).</p><p><strong>Methods: </strong>Eligible patients had symptomatic hypoparathyroidism (HypoPT) at baseline and were aged 18-85 years (inclusive). Patients received recombinant human parathyroid hormone (1-84) or placebo. The HypoPT-SD was filled in daily; data recorded at baseline and Weeks 4, 12, and 26 (end of treatment [EOT]) were included in this analysis. Inter-item and item-total correlations were used to assess HypoPT-SD structure; Cronbach's coefficient α was used to analyze the internal consistency and reliability, and intraclass correlations were used to measure test-retest reliability. Construct validity was determined using correlational analyses between HypoPT-SD scores and scores from other conceptually similar PRO tools. Ability to detect change was assessed and thresholds for meaningful within-patient change were established.</p><p><strong>Results: </strong>The psychometric analysis population (N=93) was predominantly female (88.2%) and white (96.8%), with a mean age of 48.5 years. Inter-item correlations ranged from 0.35 to 0.85 at baseline and from 0.49 to 0.93 at EOT. Item-total correlations ranged from 0.57 to 0.83 at baseline and from 0.69 to 0.88 at EOT. Cronbach's α values at baseline were 0.90 (symptom subscale) and 0.88 (impact subscale). Intraclass correlation coefficients for both subscales in stable patients exceeded 0.70. Significant cross-sectional correlations were observed with most of the conceptually linked PRO tools analyzed, and HypoPT-SD scores were responsive to change. Potential changes of 1.5 (symptom subscale) and 0.8 (impact subscale) were determined as meaningful change thresholds for within-patient improvements.</p><p><strong>Conclusion: </strong>The HypoPT-SD is a reliable measure of key symptoms and impacts of HypoPT.</p>","PeriodicalId":19747,"journal":{"name":"Patient Related Outcome Measures","volume":"16 ","pages":"539994"},"PeriodicalIF":1.8,"publicationDate":"2026-03-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12989284/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147474866","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 Evaluation of the Celiac Disease Symptom Diary 2.1^© Using Data from the Virtual Celiac Symptoms Study.","authors":"Sonal Ghura, Dawn Wiese Adams, Marilyn G Geller, Daniel A Leffler, Edwin Liu, Lori D McLeod, Lisa M Meckley, Muna J Tahir, Ragy Saad, Nicholas J Rockwood","doi":"10.2147/PROM.S553006","DOIUrl":"https://doi.org/10.2147/PROM.S553006","url":null,"abstract":"<p><strong>Purpose: </strong>Validated patient-reported outcome measures (PROMs) are required for use in clinical trials of celiac disease (CeD) therapies. The Celiac Disease Symptom Diary 2.1^© (CDSD 2.1^©), which measures the daily severity of core CeD symptoms (abdominal pain, bloating, diarrhea, nausea, tiredness), was developed according to the latest regulatory guidelines for fit-for-purpose PROMs. This study evaluated the psychometric properties of CDSD 2.1.</p><p><strong>Methods: </strong>Psychometric properties of CDSD 2.1 were evaluated using data from a 12-week US observational study, the Virtual Celiac Symptoms Study (NCT05309330), in patients with CeD maintaining a gluten-free diet. Participants completed CDSD 2.1 daily and other PROMs (Patient Global Impression of Severity [PGIS], Gastrointestinal Symptom Rating Scale [GSRS], and Celiac Symptom Index [CSI]) at specified time points to evaluate the reliability, validity, and responsiveness of CDSD 2.1.</p><p><strong>Results: </strong>Overall, 480 participants (338 adults, 142 adolescents) completed the study. Cronbach's alpha (baseline = 0.77 adults/adolescents) indicated high internal consistency reliability of weekly average gastrointestinal (GI; abdominal pain, bloating, nausea, diarrhea) CDSD 2.1 scores. An intraclass correlation coefficient of 0.89 (adults)/0.88 (adolescents) demonstrated high test-retest reliability among stable patients on PGIS. Moderate-to-strong correlations between weekly average GI CDSD 2.1 scores and GSRS domains at baseline and CSI at Week 3 confirmed construct validity (r = 0.44-0.76; <i>p</i><0.05). Weekly average GI CDSD 2.1 score changes followed expected patterns based on PGIS change groups, demonstrating responsiveness.</p><p><strong>Conclusion: </strong>This evaluation provides evidence to support the use of CDSD 2.1 in clinical trials as a reliable and responsive measure of CeD symptom severity.</p>","PeriodicalId":19747,"journal":{"name":"Patient Related Outcome Measures","volume":"16 ","pages":"553006"},"PeriodicalIF":1.8,"publicationDate":"2026-02-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12912051/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146220689","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":"Effect of a Structured Supportive and Palliative Caring Approach on the Incidence of Arrhythmia, Chest Pain, and Anxiety in CAD Patients Admitted to the Cardiac Care Unit.","authors":"Alaa Jawad Kadhim","doi":"10.2147/PROM.S561710","DOIUrl":"https://doi.org/10.2147/PROM.S561710","url":null,"abstract":"<p><strong>Purpose: </strong>Given the importance of managing chest pain, anxiety, and cardiac arrhythmia in cardiac care unit patients this study aim to determine the effect of a structured supportive and palliative care approach on these three critical aspects.</p><p><strong>Patients and methods: </strong>A randomized, double-blind, clinical trial with two groups was conducted in the second half of 2025. The research population included patients who were hospitalized in the cardiac care unit, with a final sample size of 36 people in each group. The data collection instruments included personal information, an electrocardiogram machine, a Visual Analog Scale, and the Spielberger anxiety questionnaire. The variables were measured before the intervention. Routine treatments were then continued for the control group, and in the intervention group, in addition to the routine treatments, a structured supportive and palliative care approach was implemented. Three and seven days after the intervention, these variables were measured.</p><p><strong>Results: </strong>Seventy-two patients participated in this study. As the results showed, chest pain, arrhythmia incidence, and anxiety in both groups decreased over time from the first to the third time; however, this difference was statistically significant in the intervention group for all three variables (p=0.044, 0.012, and 0.03, respectively), whereas in the control group, it was only significant in the anxiety variable (p=0. 045). The findings also showed that the mean scores of chest pain, arrhythmia incidence, and anxiety before the intervention in the two groups did not differ significantly; however, there was a significant difference in the three variables three and seven days after the intervention.</p><p><strong>Conclusion: </strong>As the results showed, supportive and palliative care approaches are effective in reducing chest pain, arrhythmia incidence, and anxiety levels in cardiac care unit patients. Therefore, it is necessary to prepare guidelines in this field based on the results of this study and other published studies.</p>","PeriodicalId":19747,"journal":{"name":"Patient Related Outcome Measures","volume":"16 ","pages":"561710"},"PeriodicalIF":1.8,"publicationDate":"2026-02-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13061331/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147646143","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 and Content Validity Evaluation of the Condition-Agnostic Treatment Goal Evaluation Scale (TGES) for Use in Chronic Conditions.","authors":"Jonathan Stokes, Katie D Stewart, Jessica B Jordan, Louis S Matza, Somali Misra Burgess, David L Van Brunt, Jessica E Hutti","doi":"10.2147/PROM.S558968","DOIUrl":"https://doi.org/10.2147/PROM.S558968","url":null,"abstract":"<p><strong>Background: </strong>Patient-reported outcomes (PROs) are important for understanding patients' experiences with their health conditions; however, individual perspectives of meaningful change for personalized treatment goals are rarely captured. Consequently, treatment outcomes assessed in clinical trials or routine practice may not align with real-world priorities or reflect individual perspectives. To bridge this gap, we developed the 2-part treatment goal evaluation scale (TGES) to assess individuals' perspectives of whether meaningful within-patient change has occurred in their self-identified treatment goal.</p><p><strong>Methodology: </strong>The draft TGES measure included the TGES - Baseline-a single, open-ended item to identify patients' primary treatment goal when starting a new treatment for a new or ongoing condition-and the TGES - Follow-Up-2 items designed to assess patients' perspectives of whether meaningful change has occurred in their self-identified goal and overall condition. Three rounds of qualitative interviews with adults aged ≥18 years with either atopic dermatitis (AD) or migraine were conducted to revise the draft TGES and assess content validity.</p><p><strong>Results: </strong>A total of 28 participants with AD (n=15) or migraine (n=13) were included; most identified as female (60.7%) and White (78.6%). Most participants interpreted the TGES - Baseline instructions (82.1%) and item (96.4%) as intended, whereas 39.3% suggested revisions to the instructions. Overall goal categories were identified: 3 AD-specific (improving physical symptoms, sensory symptoms, and choice of clothing) and 4 migraine-specific (reduced migraine frequency, impact on activities, migraine severity, and associated symptoms other than headache). Most participants interpreted the TGES - Follow-Up instructions (100.0%) and items (96.4%; 75.0%) as intended, with minor revisions suggested to improve clarity.</p><p><strong>Conclusion: </strong>Qualitative interviews supported the content validity of the TGES for identifying individual treatment goals and assessing perspectives of meaningful change. With future quantitative evaluation, the patient-centric and condition-agnostic TGES may help evaluate personalized endpoints and inform within-patient meaningful change in clinical trial and real-world settings.</p>","PeriodicalId":19747,"journal":{"name":"Patient Related Outcome Measures","volume":"16 ","pages":"558968"},"PeriodicalIF":1.8,"publicationDate":"2026-01-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13077846/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147691253","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 Use of Patient-Reported Measures Collected Data in Primary Care: A Systematic Review.","authors":"Oona Tchitcherin, An Chen, Kirsi Väyrynen, Seppo Heinonen, Paulus Torkki, Aydin Tekay","doi":"10.2147/PROM.S500933","DOIUrl":"10.2147/PROM.S500933","url":null,"abstract":"<p><p>This systematic review aims to explore the utilization of patient-reported measures (PRMs) in primary care, focusing on healthcare providers' use of PRM data and factors influencing its effectiveness. Following the PRISMA 2020 guidelines, we registered the review in PROSPERO (CRD420251030695) and screened 2465 records, ultimately including eight studies. Data extraction and quality appraisal were conducted using a structured approach and the Mixed Methods Appraisal Tool (MMAT). Findings suggest that effective PRM data use depends on integration into electronic health records (EHRs) and clinical workflows, with barriers including technical limitations and organizational culture. PRM data can support clinical decision-making, shared decision-making, and communication and support professional empowerment and resource optimization. However, evidence quality was moderate, and conclusions should be interpreted with caution due to the small number of studies. Differences in health systems and study heterogeneity further constrain generalizability. This review highlights the need for seamless EHR integration, streamlined instruments, and active professional engagement to optimize PRM implementation, while identifying a critical research gap and calling for future studies on cost-effectiveness and equity impacts.</p>","PeriodicalId":19747,"journal":{"name":"Patient Related Outcome Measures","volume":"16 ","pages":"225-243"},"PeriodicalIF":1.8,"publicationDate":"2025-12-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12742304/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145850805","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 Acceptable Symptom State for the Oxford Elbow Score After Primary Elbow Arthroplasty Due to Acute Distal Humeral Fracture.","authors":"Andreas Falkenberg Nielsen, Marc Randall Kristensen Nyring, Ali Al-Hamdani, Theis Muncholm Thillemann, Jeppe Vejlgaard Rasmussen, Bo Sanderhoff Olsen","doi":"10.2147/PROM.S547814","DOIUrl":"10.2147/PROM.S547814","url":null,"abstract":"<p><strong>Background: </strong>Patient Acceptable Symptom State (PASS) describes the highest level of symptom beyond which patients consider themselves well. PASS can be used to establish what patients' view as an acceptable outcome after surgery. The Oxford Elbow Score (OES) is one of the most used elbow-specific patient-reported outcome measure (PROM), but a PASS-value has not yet been established for the OES after elbow arthroplasty. The primary purpose of this study was to determine the PASS for the OES after primary elbow arthroplasty due to acute distal humeral fracture.</p><p><strong>Methods: </strong>This is a retrospective multi-center cohort study. All nationwide patients treated with elbow arthroplasty due to acute distal humeral fracture from January 1, 2008, until December 1, 2021, were invited to participate. Data were collected retrospectively using electronic health records. Study participants answered the OES, and a PASS-anchor question was used to assess if patients were in an acceptable state at follow-up. Logistic modelling was used to determine the PASS-value, defined as the value of OES needed to achieve an acceptable postoperative result with at least 95% probability. A PASS-value was estimated for the total population, for patients with <5 years of follow-up, and patients with ≥5 years of follow-up.</p><p><strong>Results: </strong>The OES and PASS-anchor was answered by 159 (62%) patients. Median OES was 41 (0-48) in the total population. One hundred and thirty-nine patients (87%) reported an acceptable result. The 95% PASS-value for the OES was 33 (95% CI 29.6-38.5) in the total population.</p><p><strong>Conclusion: </strong>The PASS-value for the OES after elbow arthroplasty due to acute distal humeral fracture was 33 for the total population and similar for patients with short-term and long-term follow-up. We recommend using the PASS-value to aid in interpretation of clinical trials and registry-based studies as well as identifying clinical failures in registries.</p>","PeriodicalId":19747,"journal":{"name":"Patient Related Outcome Measures","volume":"16 ","pages":"215-224"},"PeriodicalIF":1.8,"publicationDate":"2025-12-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12738753/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145850767","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":"Towards Standardization of CGM Performance Studies: The QUSS-CGM Questionnaire for Assessing User Satisfaction.","authors":"Anne Beltzer, Marta Gil Miró, Manuel Eichenlaub, Delia Waldenmaier, Cornelia Haug, Dominic Ehrmann, Guido Freckmann","doi":"10.2147/PROM.S554524","DOIUrl":"10.2147/PROM.S554524","url":null,"abstract":"<p><strong>Purpose: </strong>User satisfaction and ease of use of continuous glucose monitoring (CGM) systems are key factors in patients' device acceptance. CGM user satisfaction is often assessed through questionnaires, but item selection varies widely across studies. The aim of this study was to design, develop and validate a Questionnaire for User Satisfaction Standardized for CGM performance studies (QUSS-CGM).</p><p><strong>Methods: </strong>Selection of attributes and design of questionnaire items was based on a systematic literature search of publications on CGM performance evaluation studies. Content and response process validation of a draft-questionnaire was performed by experts (n=9) and people with diabetes (n=10), respectively. The resulting German pre-QUSS-CGM questionnaire underwent validation in two CGM performance studies (\"pilot\" studies) performed between June and August of 2024, via a pooled psychometric evaluation (exploratory factor analysis (EFA) and reliability) of n=126 questionnaires from these studies, followed by bidirectional translation to English.</p><p><strong>Results: </strong>Two hundred and five items on user satisfaction in CGM performance studies were identified by systematic literature search and classified into six attributes according to their content. Items were summarized in a 25-item draft-questionnaire on a 5-point Likert scale. Content and face validity were considered acceptable with a scale-level content validity index (S-CVI/Ave) of 0.90 and a scale-level face validity index (S-FVI/Ave) of 0.93, both based on the average method. EFA revealed a two-factor structure for the final QUSS-CGM questionnaire summarized to 11 items, demonstrating high internal consistency (Cronbach's α of 0.84).</p><p><strong>Conclusion: </strong>The QUSS-CGM was designed, developed, and validated as a reliable and standardized tool to measure user satisfaction in CGM performance evaluation studies.</p>","PeriodicalId":19747,"journal":{"name":"Patient Related Outcome Measures","volume":"16 ","pages":"203-214"},"PeriodicalIF":1.8,"publicationDate":"2025-12-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12728421/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145834338","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":"Validation of a Questionnaire for Assessing the Emotional Impact of Treatment for Type 2 Diabetes.","authors":"Louis S Matza, Katelyn N Cutts, Karin S Coyne, Kristina S Boye","doi":"10.2147/PROM.S536043","DOIUrl":"10.2147/PROM.S536043","url":null,"abstract":"<p><strong>Background: </strong>Emotional reactions to treatment could affect treatment adherence and treatment outcomes, and it is therefore important to assess the emotional impact of treatment and consider this impact in clinical decision-making. The Emotional Impact of Diabetes Treatment Questionnaire - Status version (EIDTQ-Status) was developed based on qualitative research with patients as the first patient-reported outcome measure to assess both the positive and negative emotional impacts of type 2 diabetes (T2D) and its treatment. This study assessed the psychometric properties of the EIDTQ-Status.</p><p><strong>Methods: </strong>Participants with T2D treated with a range of medications were recruited from eight clinical sites in the United States. Analysis of the EIDTQ-Status focused on item performance, subscale identification (including exploratory factor analysis), development of a scoring algorithm, test-retest reliability (intraclass correlation coefficients in a third of the participants who were randomized to attend a second visit), internal consistency reliability (Cronbach's alpha), and construct validity (via comparisons to previously validated generic and diabetes-specific instruments).</p><p><strong>Results: </strong>The sample included 250 participants (mean age = 59.7 years old; 54.4% female). Based on item performance and exploratory factor analysis, 14 items were retained and grouped into three subscales: (1) positive emotions, (2) negative emotions, and (3) sense of control over diabetes, eating, and weight, as well as a total score. The EIDTQ-Status demonstrated good internal consistency reliability (Cronbach's alphas of the three subscales and total score: 0.92, 0.88, 0.85, 0.77). Test-retest reliability was acceptable with no significant differences between administrations 7+2 days apart among stable participants (n=37; intraclass correlation coefficients: 0.85, 0.67, 0.62, and 0.88). Construct validity was supported via significant correlations with validated instruments (<i>P</i><0.0001). The EIDTQ-Status distinguished among participants who differed in reports of emotional well-being. Exploratory analysis suggests the EIDTQ-Status may differentiate between treatments. Compared with injectable semaglutide (n=47), tirzepatide-treated participants (n=58) reported a significantly greater sense of control over diabetes, eating, and weight (<i>P</i>=0.025).</p><p><strong>Conclusion: </strong>The EIDTQ-Status had strong factor structure with three subscales and a total score that demonstrated good reliability and validity. This questionnaire may be useful in clinical trials and observational research assessing the emotional impact of treatment for T2D.</p>","PeriodicalId":19747,"journal":{"name":"Patient Related Outcome Measures","volume":"16 ","pages":"191-202"},"PeriodicalIF":1.8,"publicationDate":"2025-12-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12700010/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145757086","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}