Pub Date : 2026-01-07DOI: 10.1186/s41687-025-00987-x
Courtney N Hurt, Maja Kuharic, Sara Shaunfield, Juergen Beck, Alex Bastian, Kevin Fowler, Emilie Jaeger, Marcus May, Erik van den Berg, John Friedewald, John D Peipert
{"title":"Development of a conceptual model of BKV impacts on health-related quality of life in kidney transplant recipients: a qualitative study.","authors":"Courtney N Hurt, Maja Kuharic, Sara Shaunfield, Juergen Beck, Alex Bastian, Kevin Fowler, Emilie Jaeger, Marcus May, Erik van den Berg, John Friedewald, John D Peipert","doi":"10.1186/s41687-025-00987-x","DOIUrl":"10.1186/s41687-025-00987-x","url":null,"abstract":"","PeriodicalId":36660,"journal":{"name":"Journal of Patient-Reported Outcomes","volume":" ","pages":"4"},"PeriodicalIF":2.9,"publicationDate":"2026-01-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12789305/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145913251","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}
Pub Date : 2025-12-31DOI: 10.1186/s41687-025-00988-w
Maria Aagesen, Helle Pappot, Karin Piil, Ligita Paskeviciute Frøding, Emma Balch Steen-Olsen, Elfriede Greimel, Line Bentsen
{"title":"Exploration of the relevance and comprehensibility of the European Organization for the Research and Treatment of Cancer Sexual Health Questionnaire among Danish young adults aged 18-39: a national cross-sectional study.","authors":"Maria Aagesen, Helle Pappot, Karin Piil, Ligita Paskeviciute Frøding, Emma Balch Steen-Olsen, Elfriede Greimel, Line Bentsen","doi":"10.1186/s41687-025-00988-w","DOIUrl":"10.1186/s41687-025-00988-w","url":null,"abstract":"","PeriodicalId":36660,"journal":{"name":"Journal of Patient-Reported Outcomes","volume":" ","pages":"3"},"PeriodicalIF":2.9,"publicationDate":"2025-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12770101/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145865799","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}
Pub Date : 2025-12-29DOI: 10.1186/s41687-025-00972-4
Andrea Phillips-Beyer, Ariane K Kawata, Leah Kleinman, Antonio Olivieri
{"title":"Confirming content validity of The Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ) among adults with insomnia in four European countries.","authors":"Andrea Phillips-Beyer, Ariane K Kawata, Leah Kleinman, Antonio Olivieri","doi":"10.1186/s41687-025-00972-4","DOIUrl":"10.1186/s41687-025-00972-4","url":null,"abstract":"","PeriodicalId":36660,"journal":{"name":"Journal of Patient-Reported Outcomes","volume":"9 1","pages":"143"},"PeriodicalIF":2.9,"publicationDate":"2025-12-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12748474/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145858105","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}
Pub Date : 2025-12-22DOI: 10.1186/s41687-025-00983-1
Ron D Hays, Julie A Brown, Emma Bianculli, Marc Elliott
<p><strong>Background: </strong>The Consumer Assessment of Healthcare Providers and Systems (CAHPS<sup>®</sup>) surveys are widely used to evaluate patients' experiences with healthcare. Although the surveys have been extensively assessed and periodically updated, concerns persist regarding their content, length, and score distributions. This study aimed to gather systematic stakeholder feedback to inform future revisions of CAHPS ambulatory surveys.</p><p><strong>Methodology: </strong>A modified Delphi method was employed using the ExpertLens™ online platform. A panel of 20 members representing a broad stakeholder community, including survey sponsors, survey experts, patient experience advocates, and federal representatives, participated in three phases. The first phase was an initial rating of the essentialness (required, optional, not essential) of 46 existing item topics using a 1 (Not Essential) to 9 (Very Essential) scale with scores of 1-3 used for a topic that should not be included, 4-6 used for a topic that should be optional, and 7-9 for a topic that should be required in a CAHPS survey of health plans, clinicians, or group practices. The second phase was an asynchronous online discussion of the initial ratings, and the third phase was a final rating of the 46 existing item topics. The reliability of ratings was assessed using a mixed-effects analysis of variance model. Means and standard deviations of essentialness ratings were also analyzed. Verbatim comments from the experts were summarized to provide additional insights.</p><p><strong>Results: </strong>Reliability of expert 1-9 essentialness ratings improved from the initial round (reliability = 0.63, intraclass correlation = 0.08) to the final round (reliability = 0.70, intraclass correlation = 0.10). While most existing items were deemed essential by most stakeholders, there were noteworthy (0.08 or larger) increases from the initial to final rating phases in essentialness for items related to digital access, medication reconciliation, provider communication, and appeals processes, and notable decreases for specialist care ratings, access to medical questions during off-hours, and provider knowledge of chronic conditions. Stakeholders emphasized the importance of access to care, communication and coordination, respectful interactions with staff and providers, and clear cost information. Several potential topics missing from current surveys were identified, including unfair treatment, mental health integration, maternity care, language concordance, trust, self-management, patient safety, continuity of care, care coordination, and claims processing.</p><p><strong>Conclusions: </strong>This study provides valuable insights into stakeholder perspectives on the relevance and potential improvements to CAHPS ambulatory survey content. The findings support revisions to existing items to enhance their clarity and actionability, as well as the inclusion of new topics that reflect evolving
{"title":"Stakeholder input on the CAHPS ambulatory surveys.","authors":"Ron D Hays, Julie A Brown, Emma Bianculli, Marc Elliott","doi":"10.1186/s41687-025-00983-1","DOIUrl":"10.1186/s41687-025-00983-1","url":null,"abstract":"<p><strong>Background: </strong>The Consumer Assessment of Healthcare Providers and Systems (CAHPS<sup>®</sup>) surveys are widely used to evaluate patients' experiences with healthcare. Although the surveys have been extensively assessed and periodically updated, concerns persist regarding their content, length, and score distributions. This study aimed to gather systematic stakeholder feedback to inform future revisions of CAHPS ambulatory surveys.</p><p><strong>Methodology: </strong>A modified Delphi method was employed using the ExpertLens™ online platform. A panel of 20 members representing a broad stakeholder community, including survey sponsors, survey experts, patient experience advocates, and federal representatives, participated in three phases. The first phase was an initial rating of the essentialness (required, optional, not essential) of 46 existing item topics using a 1 (Not Essential) to 9 (Very Essential) scale with scores of 1-3 used for a topic that should not be included, 4-6 used for a topic that should be optional, and 7-9 for a topic that should be required in a CAHPS survey of health plans, clinicians, or group practices. The second phase was an asynchronous online discussion of the initial ratings, and the third phase was a final rating of the 46 existing item topics. The reliability of ratings was assessed using a mixed-effects analysis of variance model. Means and standard deviations of essentialness ratings were also analyzed. Verbatim comments from the experts were summarized to provide additional insights.</p><p><strong>Results: </strong>Reliability of expert 1-9 essentialness ratings improved from the initial round (reliability = 0.63, intraclass correlation = 0.08) to the final round (reliability = 0.70, intraclass correlation = 0.10). While most existing items were deemed essential by most stakeholders, there were noteworthy (0.08 or larger) increases from the initial to final rating phases in essentialness for items related to digital access, medication reconciliation, provider communication, and appeals processes, and notable decreases for specialist care ratings, access to medical questions during off-hours, and provider knowledge of chronic conditions. Stakeholders emphasized the importance of access to care, communication and coordination, respectful interactions with staff and providers, and clear cost information. Several potential topics missing from current surveys were identified, including unfair treatment, mental health integration, maternity care, language concordance, trust, self-management, patient safety, continuity of care, care coordination, and claims processing.</p><p><strong>Conclusions: </strong>This study provides valuable insights into stakeholder perspectives on the relevance and potential improvements to CAHPS ambulatory survey content. The findings support revisions to existing items to enhance their clarity and actionability, as well as the inclusion of new topics that reflect evolving ","PeriodicalId":36660,"journal":{"name":"Journal of Patient-Reported Outcomes","volume":" ","pages":"14"},"PeriodicalIF":2.9,"publicationDate":"2025-12-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12834880/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145805688","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}
Pub Date : 2025-12-21DOI: 10.1186/s41687-025-00986-y
Melissa J Benton, Andrea M Hutchins
Background: Accurate assessment of physical activity behaviors allows clinicians to target counseling more effectively. Single questions regarding habitual physical activity provide the most feasible option for rapid physical activity assessment. This study evaluated construct validity of a single item physical activity question to self-report habitual activity as simple categorical descriptors (not active, somewhat active, active, very active).
Methods: Women (N = 120) completed one laboratory session for measurement of self-reported physical activity (International Physical Activity Questionnaire-IPAQ), anthropometrics and body composition, and physical activity-related quality of life (SF-36 physical function subscale, Vitality Plus Scale). Construct validity was evaluated as convergent and known-groups validity.
Results: Mean age was 60 ± 16 years (range 25-89). The majority (62%) reported being active or very active. Age was not significantly related to activity levels. Correlation analysis demonstrated good convergent validity. Significant negative correlations were found with body weight, body mass index (BMI), waist circumference, and body fat (all p <0.001). Significant positive correlations were found with vigorous intensity activity (p <0.001), moderate intensity activity (p = .004), walking (p = .005), and quality of life (p <0.001). Good known-groups validity was demonstrated by significant differences between habitual physical activity levels for body weight, waist circumference, body fat, vigorous intensity activity (all p <0.001), moderate intensity activity (p = .038), walking (p = .049), and quality of life (p <0.001). Regression models confirmed known-groups validity.
Conclusions: A single question with categorical descriptors is valid for brief clinical assessment of habitual physical activity in women across a wide age range.
{"title":"Validation of a single question for assessment of habitual physical activity in women.","authors":"Melissa J Benton, Andrea M Hutchins","doi":"10.1186/s41687-025-00986-y","DOIUrl":"10.1186/s41687-025-00986-y","url":null,"abstract":"<p><strong>Background: </strong>Accurate assessment of physical activity behaviors allows clinicians to target counseling more effectively. Single questions regarding habitual physical activity provide the most feasible option for rapid physical activity assessment. This study evaluated construct validity of a single item physical activity question to self-report habitual activity as simple categorical descriptors (not active, somewhat active, active, very active).</p><p><strong>Methods: </strong>Women (N = 120) completed one laboratory session for measurement of self-reported physical activity (International Physical Activity Questionnaire-IPAQ), anthropometrics and body composition, and physical activity-related quality of life (SF-36 physical function subscale, Vitality Plus Scale). Construct validity was evaluated as convergent and known-groups validity.</p><p><strong>Results: </strong>Mean age was 60 ± 16 years (range 25-89). The majority (62%) reported being active or very active. Age was not significantly related to activity levels. Correlation analysis demonstrated good convergent validity. Significant negative correlations were found with body weight, body mass index (BMI), waist circumference, and body fat (all p <0.001). Significant positive correlations were found with vigorous intensity activity (p <0.001), moderate intensity activity (p = .004), walking (p = .005), and quality of life (p <0.001). Good known-groups validity was demonstrated by significant differences between habitual physical activity levels for body weight, waist circumference, body fat, vigorous intensity activity (all p <0.001), moderate intensity activity (p = .038), walking (p = .049), and quality of life (p <0.001). Regression models confirmed known-groups validity.</p><p><strong>Conclusions: </strong>A single question with categorical descriptors is valid for brief clinical assessment of habitual physical activity in women across a wide age range.</p>","PeriodicalId":36660,"journal":{"name":"Journal of Patient-Reported Outcomes","volume":" ","pages":"13"},"PeriodicalIF":2.9,"publicationDate":"2025-12-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145805699","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}
Pub Date : 2025-12-20DOI: 10.1186/s41687-025-00984-0
Lea Doppelbauer, Anna Maria Hage, Maria Margarete Karsten, Pimrapat Gebert, Anna Tatzber, Laura Hatzler, Jasper Brands, Rosanne Andriessen, Therese Pross
{"title":"Quantitative assessment of visual designs for communicating patient-reported outcomes in breast cancer care to patients.","authors":"Lea Doppelbauer, Anna Maria Hage, Maria Margarete Karsten, Pimrapat Gebert, Anna Tatzber, Laura Hatzler, Jasper Brands, Rosanne Andriessen, Therese Pross","doi":"10.1186/s41687-025-00984-0","DOIUrl":"10.1186/s41687-025-00984-0","url":null,"abstract":"","PeriodicalId":36660,"journal":{"name":"Journal of Patient-Reported Outcomes","volume":" ","pages":"12"},"PeriodicalIF":2.9,"publicationDate":"2025-12-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12830510/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145800705","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}
Pub Date : 2025-12-15DOI: 10.1186/s41687-025-00979-x
Ana B Gago-Veiga, Nuria González-García, Javier Díaz-de-Terán, Patricia Heredia-Rodríguez, Beatriz Armada-Peláez, Carlota Moya-Alarcón, Javier Soto-Álvarez, Javier Rejas-Gutiérrez, Miguel Á Ruiz-Díaz
<p><strong>Background: </strong>The patient's perspective is increasingly relevant in health decision making. In daily practice, care of patients with migraine should include evaluation of their satisfaction with acute and preventive treatments, the interference with daily living, as well as with the care received by the healthcare team. The aim was to develop and validate a novel specific self-reported patient-reported-experience measure (PREM) in Spanish (Spain), to ascertain satisfaction with migraine treatment; the MISAT-Q questionnaire.</p><p><strong>Methodology: </strong>A multicenter, crosssectional, non-interventional study was conducted between June 2023 and March 2024 in headache units in Spain. Patients with migraine currently receiving treatment were included. A 35-items preliminary instrument was developed after literature review and cognitive debriefing with experts and patients. Three samples were used: a) 23 patients to assess feasibility/pertinence of items; b) 158 patients for item reduction; and c) 209 patients for validation of PREM. Measures for concept validity included Patient Global Impression of change (PGI), Headache Impact Scale-6 items (HIT-6), and Health-Related Quality-of-life (EQ-5D-3 L). Feasibility, reliability and validity (content, discriminant, construct, and concurrent) were assessed.</p><p><strong>Results: </strong>Feasibility: face value (good acceptance to answer the questionnaire), administration time (below 10 minutes), floor and ceiling effects (below 40% in any extreme response category), percentage of missing values in each item (below 20%) was found in the validation sample. Factor analysis item reduction resulted in a 22-item questionnaire with 7 dimensions: undesirable side effects, treatment effectiveness in crisis and in prevention, convenience-of-use, impact on daily activities, medical care, and global satisfaction, supported with confirmatory factor analysis: CFI = 0.983; TLI = 0.980; χ<sup>2</sup>/df = 1.808; RMSEA = 0.075. Reliability was high: Cronbach's alpha = 0.90 and intraclass-correlation coefficient = 0.95. Dimensions of questionnaire showed significant and moderate convergent correlations with the overall score (0.58-0.68, p < 0.001). Concurrent validity with HIT-6 showed correlation's coefficients ranging from -0.19 to -0.48 (p < 0.01 in all cases, except medical care) and with EQ-5D-3 L (correlations from 0.17 to 0.39, p < 0.05 in all cases, except medical care). Differences in satisfaction were found according with migraine severity (F = 6.73, p = 0.002), as well as in HIT-6 scores (F = 8.20, p < 0.002). MISAT-Q discriminated overall satisfaction between patients with worse, no change and better change with treatment (F = 15.85; p < 0.001).</p><p><strong>Conclusions: </strong>The MISAT-Q questionnaire is a well-accepted, reliable and valid measure of migraine treatment satisfaction in Spanish. Responsiveness attribute needs to be explored. This novel PREM may facilitate clinicians
{"title":"Development and validation of a patient-reported-experience measure to ascertain treatment satisfaction in migraine: the MISAT-Q questionnaire.","authors":"Ana B Gago-Veiga, Nuria González-García, Javier Díaz-de-Terán, Patricia Heredia-Rodríguez, Beatriz Armada-Peláez, Carlota Moya-Alarcón, Javier Soto-Álvarez, Javier Rejas-Gutiérrez, Miguel Á Ruiz-Díaz","doi":"10.1186/s41687-025-00979-x","DOIUrl":"10.1186/s41687-025-00979-x","url":null,"abstract":"<p><strong>Background: </strong>The patient's perspective is increasingly relevant in health decision making. In daily practice, care of patients with migraine should include evaluation of their satisfaction with acute and preventive treatments, the interference with daily living, as well as with the care received by the healthcare team. The aim was to develop and validate a novel specific self-reported patient-reported-experience measure (PREM) in Spanish (Spain), to ascertain satisfaction with migraine treatment; the MISAT-Q questionnaire.</p><p><strong>Methodology: </strong>A multicenter, crosssectional, non-interventional study was conducted between June 2023 and March 2024 in headache units in Spain. Patients with migraine currently receiving treatment were included. A 35-items preliminary instrument was developed after literature review and cognitive debriefing with experts and patients. Three samples were used: a) 23 patients to assess feasibility/pertinence of items; b) 158 patients for item reduction; and c) 209 patients for validation of PREM. Measures for concept validity included Patient Global Impression of change (PGI), Headache Impact Scale-6 items (HIT-6), and Health-Related Quality-of-life (EQ-5D-3 L). Feasibility, reliability and validity (content, discriminant, construct, and concurrent) were assessed.</p><p><strong>Results: </strong>Feasibility: face value (good acceptance to answer the questionnaire), administration time (below 10 minutes), floor and ceiling effects (below 40% in any extreme response category), percentage of missing values in each item (below 20%) was found in the validation sample. Factor analysis item reduction resulted in a 22-item questionnaire with 7 dimensions: undesirable side effects, treatment effectiveness in crisis and in prevention, convenience-of-use, impact on daily activities, medical care, and global satisfaction, supported with confirmatory factor analysis: CFI = 0.983; TLI = 0.980; χ<sup>2</sup>/df = 1.808; RMSEA = 0.075. Reliability was high: Cronbach's alpha = 0.90 and intraclass-correlation coefficient = 0.95. Dimensions of questionnaire showed significant and moderate convergent correlations with the overall score (0.58-0.68, p < 0.001). Concurrent validity with HIT-6 showed correlation's coefficients ranging from -0.19 to -0.48 (p < 0.01 in all cases, except medical care) and with EQ-5D-3 L (correlations from 0.17 to 0.39, p < 0.05 in all cases, except medical care). Differences in satisfaction were found according with migraine severity (F = 6.73, p = 0.002), as well as in HIT-6 scores (F = 8.20, p < 0.002). MISAT-Q discriminated overall satisfaction between patients with worse, no change and better change with treatment (F = 15.85; p < 0.001).</p><p><strong>Conclusions: </strong>The MISAT-Q questionnaire is a well-accepted, reliable and valid measure of migraine treatment satisfaction in Spanish. Responsiveness attribute needs to be explored. This novel PREM may facilitate clinicians ","PeriodicalId":36660,"journal":{"name":"Journal of Patient-Reported Outcomes","volume":" ","pages":"10"},"PeriodicalIF":2.9,"publicationDate":"2025-12-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12819897/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145757901","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}
Pub Date : 2025-12-12DOI: 10.1186/s41687-025-00975-1
Sean N Halpin, Doesjka A Hagenaar, Sarah Nelson Potter, Emma van Wooning, Angela Gwaltney, Sabine E Mous, Anne C Wheeler
{"title":"Advancing observer-reported outcome measurement: development of the MOOD-AS for observing distress in Angelman syndrome.","authors":"Sean N Halpin, Doesjka A Hagenaar, Sarah Nelson Potter, Emma van Wooning, Angela Gwaltney, Sabine E Mous, Anne C Wheeler","doi":"10.1186/s41687-025-00975-1","DOIUrl":"10.1186/s41687-025-00975-1","url":null,"abstract":"","PeriodicalId":36660,"journal":{"name":"Journal of Patient-Reported Outcomes","volume":" ","pages":"8"},"PeriodicalIF":2.9,"publicationDate":"2025-12-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12816459/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145744876","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}
Pub Date : 2025-12-12DOI: 10.1186/s41687-025-00968-0
Alan L Shields, Nina Galipeau, Leighann Litcher-Kelly, Alejandro Moreno-Koehler, Jimmy Chacko
<p><strong>Background: </strong>Patient-reported outcomes (PROs) are underutilized in medical device evaluations, including in ophthalmology and intraocular lens (IOL) replacements. This article summarizes research conducted to develop the Patient-Reported Intraocular Lens Questionnaire (PR-ILQ) and support its content validity and psychometric performance. Use of the PR-ILQ in a regulated clinical trial to support new product approval decisions, secondary effectiveness claims, and safety observations is also discussed.</p><p><strong>Results: </strong>The PR-ILQ, developed with ophthalmology experts (n = 10) and use of qualitative data generated from patients during concept elicitation (n = 44) and cognitive debriefing (n = 32) interviews, includes the Vision Correction Scale (VCS, three items), Vision Disturbance Scale (VDS, eight items), and IOL Replacement Satisfaction Scale (IOL-RSS, five items). Each assessment is distinct, and items within each are scored independently to address treatment benefit hypotheses. With its content validity established, the PR-ILQ was administered to 271 subjects (mean age = 68.3 years) participating in a clinical trial to evaluate the safety and effectiveness of an asymmetric segmented multifocal IOL (SBL-INI-02-13). Descriptively, item scores behaved as expected, with clustering of VCS and VDS scores at more- and less-severe levels at study entry and exit, respectively, though scores were distributed across response options across timepoints. Test-retest reliability results mostly indicate "fair"/"good" (weighted Kappa [KW]/intraclass correlation coefficient [ICC] > 0.40 to 0.60) to "excellent" (KW/ICC > 0.75) reproducibility for VCS, VDS, and IOL-RSS items in two independent analyses. Construct validity hypotheses, including those associated with sensitivity to change, were supported via correlational analysis showing a pattern of expected relationships among PR-ILQ items and with other variables including ratings of visual acuity. For example, reduced use of vision correction at near (r = -0.28), intermediate (r = -0.42), and far (r = -0.57) distances were more strongly related to overall lens satisfaction at end of study than improved visual acuity at those same distances (r = -0.25. -0.26, and -0,14).</p><p><strong>Conclusions: </strong>The PR-ILQ is content valid and early evidence suggests it is capable of producing reliable scores upon which valid conclusions may be drawn when administered among patients undergoing cataract lens replacement surgery. Acknowledging limitations and need for additional psychometric evaluation, the assessment recently supported a new product approval decision, secondary effectiveness claims, and safety observations. Together, this indicates that the PR-ILQ, along with the evidentiary basis and suggestions for use presented herein, will be of immediate value to IOL replacement outcomes researchers, regulators, and other stakeholders interested in generating evidence to inform
{"title":"The patient reported intraocular lens questionnaire (PR-ILQ): content validity, psychometric performance, and use in a regulated clinical trial to evaluate safety and effectiveness outcomes.","authors":"Alan L Shields, Nina Galipeau, Leighann Litcher-Kelly, Alejandro Moreno-Koehler, Jimmy Chacko","doi":"10.1186/s41687-025-00968-0","DOIUrl":"10.1186/s41687-025-00968-0","url":null,"abstract":"<p><strong>Background: </strong>Patient-reported outcomes (PROs) are underutilized in medical device evaluations, including in ophthalmology and intraocular lens (IOL) replacements. This article summarizes research conducted to develop the Patient-Reported Intraocular Lens Questionnaire (PR-ILQ) and support its content validity and psychometric performance. Use of the PR-ILQ in a regulated clinical trial to support new product approval decisions, secondary effectiveness claims, and safety observations is also discussed.</p><p><strong>Results: </strong>The PR-ILQ, developed with ophthalmology experts (n = 10) and use of qualitative data generated from patients during concept elicitation (n = 44) and cognitive debriefing (n = 32) interviews, includes the Vision Correction Scale (VCS, three items), Vision Disturbance Scale (VDS, eight items), and IOL Replacement Satisfaction Scale (IOL-RSS, five items). Each assessment is distinct, and items within each are scored independently to address treatment benefit hypotheses. With its content validity established, the PR-ILQ was administered to 271 subjects (mean age = 68.3 years) participating in a clinical trial to evaluate the safety and effectiveness of an asymmetric segmented multifocal IOL (SBL-INI-02-13). Descriptively, item scores behaved as expected, with clustering of VCS and VDS scores at more- and less-severe levels at study entry and exit, respectively, though scores were distributed across response options across timepoints. Test-retest reliability results mostly indicate \"fair\"/\"good\" (weighted Kappa [KW]/intraclass correlation coefficient [ICC] > 0.40 to 0.60) to \"excellent\" (KW/ICC > 0.75) reproducibility for VCS, VDS, and IOL-RSS items in two independent analyses. Construct validity hypotheses, including those associated with sensitivity to change, were supported via correlational analysis showing a pattern of expected relationships among PR-ILQ items and with other variables including ratings of visual acuity. For example, reduced use of vision correction at near (r = -0.28), intermediate (r = -0.42), and far (r = -0.57) distances were more strongly related to overall lens satisfaction at end of study than improved visual acuity at those same distances (r = -0.25. -0.26, and -0,14).</p><p><strong>Conclusions: </strong>The PR-ILQ is content valid and early evidence suggests it is capable of producing reliable scores upon which valid conclusions may be drawn when administered among patients undergoing cataract lens replacement surgery. Acknowledging limitations and need for additional psychometric evaluation, the assessment recently supported a new product approval decision, secondary effectiveness claims, and safety observations. Together, this indicates that the PR-ILQ, along with the evidentiary basis and suggestions for use presented herein, will be of immediate value to IOL replacement outcomes researchers, regulators, and other stakeholders interested in generating evidence to inform ","PeriodicalId":36660,"journal":{"name":"Journal of Patient-Reported Outcomes","volume":"9 1","pages":"142"},"PeriodicalIF":2.9,"publicationDate":"2025-12-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12701150/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145744793","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}
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