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Objectives: Health state utility (HSU) instruments for calculating quality-adjusted life years, such as the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Utility - Core 10 Dimensions (QLU-C10D), derived from the EORTC QLQ-30 questionnaire, the Patient-Reported Outcome Measurement Information System (PROMIS) preference score (PROPr), and the EuroQoL-5-Dimensions-5-Levels (EQ-5D-5L), yield different HSU values due to different modeling and different underlying descriptive scales. For example the QLU-C10D includes cancer-relevant dimensions such as nausea. This study aimed to investigate how these differences in descriptive scales contribute to differences in HSU scores by comparing scores of cancer patients receiving chemotherapy to those of the general population., Study Design and Setting: EORTC QLU-C10D, PROPr, and EQ-5D-5L scores were obtained for a convenience sample of 484 outpatients of the Department of Oncology, Charité - Universitätsmedizin Berlin, Germany. Convergent and known group's validity were assessed using Pearson's correlation and intraclass correlation coefficients (ICC). We assessed each descriptive dimension score's discriminatory power and compared them to those of the general population (n > 1000) using effect size (ES; Cohen's d) and area under the curve (AUC)., Results: The mean scores of QLU-C10D (0.64; 95% CI 0.62-0.67), PROPr (0.38; 95% CI 0.36-0.40), and EQ-5D-5L (0.72; 95% CI 0.70-0.75) differed significantly, irrespective of sociodemographic factors, condition, or treatment. Conceptually similar descriptive scores as obtained from the HSU instruments showed varying degrees of discrimination in terms of ES and AUC between patients and the general population. The QLU-C10D and its dimensions showed the largest ES and AUC., Conclusion: The QLU-C10D and its domains distinguished best between health states of the two populations, compared to the PROPr and EQ-5D-5L. As the EORTC Core Quality of Life Questionnaire (QLQ-C30) is widely used in clinical practice, its data are available for economic evaluation., Plain Language Summary: The assessment of dimensions of health-related quality of life (HRQoL), such as physical functioning or depression, is important to cancer patients and physicians for treatment and side effect monitoring. Descriptive HRQoL is measured by patient-reported outcomes measures (PROM). The European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire and the Patient-Reported Outcome Measurement Information System (PROMIS) are the most common PROM in the clinical HRQoL assessment. In recent years, multidimensional preference-based HRQoL measures were developed using these PROM as dimensions. These preference-based measures, also referred to as health state utility (HSU) scores, are needed for economic evaluations of treatments. The QLQ-C30's corresponding HSU score is the Quality of Life Utility measure-Core 10 Dimensions (QLU-C10D), and PROMIS' HSU score is the PROMIS preference score (PROPr). Both new HSU scores are frequently compared to the well-established EuroQoL-5-dimensions-5-levels (EQ-5D-5L). They all conceptualize HSU differently, as they assess different dimensions of HRQoL und use different models. Both the QLU-C10D and the PROPr have thus shown systematic differences to the EQ-5D-5L but these were largely consistent across the subgroups. Convergent and known groups validity can therefore be considered established. However, as HSU is a multidimensional construct, it remains unclear how differences in its dimensions, for example, its descriptive scales, contribute to differences in HSU scores. This is of importance as it is the descriptive scales that measure clinical HRQoL. We investigated this question by assessing each dimension's ability to distinguish between a sample of 484 cancer patients and the German general population. We could show that the ability to distinguish depended on the domain: for example, for depression, the QLU-C10D and EQ-5D-5L distinguished clearer, while for physical function, PROMIS did. Overall, the QLU-C10D and its dimensions distinguish best between cancer patients and general population., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence., (Copyright © 2024 The Author(s). Published by Elsevier Inc. All rights reserved.)

Background: Although outcome goals for acute healthcare among older people living with frailty often include Health-Related Quality of Life (HRQoL) and other patient-reported outcome measures (PROMs), current quality metrics usually focus on waiting times and survival. Lay and patient review have identified the EuroQol EQ-5D as a candidate measure for this setting. This research appraised the EQ-5D for feasibility, psychometric performance, and respondents' outcomes in the acute frailty setting., Methods: People aged 65 + with Clinical Frailty Scale (CFS) 5-8 were recruited from eight UK hospitals' emergency care and acute admissions settings. They completed the five-level EQ-5D and the EQ-VAS. Feasibility was assessed with completion times and completeness. For reliability, response distributions and internal consistency were analysed. Finally, EQ-Index values were compared with demographic characteristics and service outcomes for construct validity., Results: The 232 participants were aged 65-102. 38% responded in emergency departments and 62% in admissions wards. Median completion time was 12 (IQR, 11) minutes. 98% responses were complete. EQ-5D had acceptable response distribution (SD 1.1-1.3) and internal consistency (Cronbach's alpha 0.69). EQ-VAS demonstrated a midpoint response pattern. Median EQ-Index was 0.574 (IQR, 0.410) and was related positively with increasing age (p = 0.010) and negatively with CFS (p < 0.001). Participants with higher CFS had more frequent problems with mobility, self-care, and usual activities., Conclusions: Administration of the EQ-5D was feasible in these emergency and acute frailty care settings. EQ-5D had acceptable properties, while EQ-VAS appeared problematic. Participants with more severe frailty had also poorer HRQoL., (© 2023. The Author(s).)

Background: Research shows that feeding back patient-reported outcome information to clinicians and/or patients could be associated with improved care processes and patient outcomes. Quantitative syntheses of intervention effects on oncology patient outcomes are lacking., Objective: To determine the effects of patient-reported outcome measure (PROM) feedback intervention on oncology patient outcomes., Data Sources: We identified relevant studies from 116 references included in our previous Cochrane review assessing the intervention for the general population. In May 2022, we conducted a systematic search in five bibliography databases using predefined keywords for additional studies published after the Cochrane review., Study Selection: We included randomized controlled trials evaluating the effects of PROM feedback intervention on processes and outcomes of care for oncology patients., Data Extraction and Synthesis: We used the meta-analytic approach to synthesize across studies measuring the same outcomes. We estimated pooled effects of the intervention on outcomes using Cohen's d for continuous data and risk ratio (RR) with a 95% confidence interval for dichotomous data. We used a descriptive approach to summarize studies which reported insufficient data for a meta-analysis., Main Outcome(s) and Measures(s): Health-related quality of life (HRQL), symptoms, patient-healthcare provider communication, number of visits and hospitalizations, number of adverse events, and overall survival., Results: We included 29 studies involving 7071 cancer participants. A small number of studies was available for each metanalysis (median = 3 studies, ranging from 2 to 9 studies) due to heterogeneity in the evaluation of the trials. We found that the intervention improved HRQL (Cohen's d = 0.23, 95% CI 0.11-0.34), mental functioning (Cohen's d = 0.14, 95% CI 0.02-0.26), patient-healthcare provider communication (Cohen's d = 0.41, 95% CI 0.20-0.62), and 1-year overall survival (OR = 0.64, 95% CI 0.48-0.86). The risk of bias across studies was considerable in the domains of allocation concealment, blinding, and intervention contamination., Conclusions and Relevance: Although we found evidence to support the intervention for highly relevant outcomes, our conclusions are tempered by the high risk of bias relating mainly to intervention design. PROM feedback for oncology patients may improve processes and outcomes for cancer patients but more high-quality evidence is required., (© 2023. The Author(s).)

Objectives: The Patient-Reported Outcome Measurement Information System (PROMIS) Preference score (PROPr) can be used to assess health state utility (HSU) and estimate quality-adjusted life-years in cost-effectiveness analyses. It is based on item response theory and promises to overcome limitations of existing HSU scores such as ceiling effects. The PROPr contains 7 PROMIS domains: cognitive abilities, depression, fatigue, pain, physical function, sleep disturbance, and ability to participate in social roles and activities. We aimed to compare the PROPr with the 5-level EQ-5D (EQ-5D-5L) in terms of psychometric properties using data from 3 countries., Methods: We collected PROMIS-29 profile and EQ-5D-5L data from 3 general population samples (United Kingdom = 1509, France = 1501, Germany = 1502). Given that cognition is not assessed by the PROMIS-29, it was predicted by the recommended linear regression model. We compared the convergent validity, known-groups construct validity, and ceiling and floor effects of the PROPr and EQ-5D-5L., Results: The mean PROPr (0.48, 0.53, 0.48; P<.01) and EQ-5D-5L scores (0.82, 0.85, 0.83; P<.01) showed significant differences of similar magnitudes (d = 0.34; d = 0.32; d = 0.35; P<.01) across all samples. The differences were invariant to sex, income, occupation, education, and most conditions but not for age. The Pearson correlation coefficients between both scores were r = 0.74, r = 0.69, and r = 0.72. PROPr's ceiling and floor effects both were minor to moderate. The EQ-5D-5L's ceiling (floor) effects were major (negligible)., Conclusions: Both the EQ-5D-5L and the PROPr assessed by the PROMIS-29 show high validity. The PROPr yields considerably lower HSU values than the EQ-5D-5L. Consequences for quality-adjusted life-year measurements should be investigated in future research., (Copyright © 2021. Published by Elsevier Inc.)

Background: Hypertension is a highly prevalent condition, with optimal treatment to BP targets conferring significant gains in terms of cardiovascular outcomes. Understanding why some patients do not achieve BP targets would be enhanced through greater understanding of their health-related quality of life (HRQoL). However, the only English language disease-specific instruments for measurement of HRQoL in hypertension have not been validated in accordance with accepted standards. It is proposed that the Spanish MINICHAL instrument for the assessment of HRQoL in hypertension could be translated, adapted and validated for use in the United Kingdom. The aim of the study was therefore to complete this process., Methods: The MINICHAL authors were contacted and the original instrument obtained. This was then translated into English by two independent English-speakers, with these versions then reconciled, before back-translation and subsequent production of a 2nd reconciled version. Thereafter, a final version was produced after cognitive debriefing, for administration and psychometric analysis in the target population of patients living in the Exeter area (Southwest UK) aged 18-80 years with treatment-naïve grade II-III hypertension, before, during and after 18 weeks' intensive treatment., Results: The English-language instrument was administered to 30 individuals (median age: 58.5 years, 53% male). Psychometric analysis demonstrated a floor effect, though no ceiling effect. Internal consistency for both state of mind (StM) and somatic manifestations (SM) dimensions of the instrument were acceptable (Cronbach's alpha = 0.81 and 0.75), as was test-retest reliability (ICC = 0.717 and 0.961) and construct validity, which was measured through co-administration with the EQ-5D-5L and Bulpitt-Fletcher instruments. No significant associations were found between scores and patient characteristics known to affect HRQoL. The EQ-5D-5L instrument found an improvement in HRQoL following treatment, with the StM and SM dimensions of the English language MINICHAL trending to support this (d = 0.32 and 0.02 respectively)., Conclusions: The present study details the successful English translation and validation of the MINICHAL instrument for use in individuals with hypertension. The data reported also supports an improvement in HRQoL with rapid treatment of grade II-III hypertension, a strategy which has been recommended by contemporaneous European guidelines. Trial registration ISRCTN registry number: 57475376 (assigned 25/06/2015)., (© 2022. The Author(s).)

Background: Patient-reported outcomes measures (PROMs) assess a patient's subjective appraisal of health outcomes from their own perspective. Despite hypothesised benefits that feedback  on PROMs can support decision-making in clinical practice and improve outcomes, there is uncertainty surrounding the effectiveness of PROMs feedback., Objectives: To assess the effects of PROMs feedback to patients, or healthcare workers, or both on patient-reported health outcomes and processes of care., Search Methods: We searched MEDLINE, Embase, CENTRAL, two other databases and two clinical trial registries on 5 October 2020. We searched grey literature and consulted experts in the field., Selection Criteria: Two review authors independently screened and selected studies for inclusion. We included randomised trials directly comparing the effects on outcomes and processes of care of PROMs feedback to healthcare professionals and patients, or both with the impact of not providing such information., Data Collection and Analysis: Two groups of two authors independently extracted data from the included studies and evaluated study quality. We followed standard methodological procedures expected by Cochrane and EPOC. We used the GRADE approach to assess the certainty of the evidence. We conducted meta-analyses of the results where possible., Main Results: We identified 116 randomised trials which assessed the effectiveness of PROMs feedback in improving processes or outcomes of care, or both in a broad range of disciplines including psychiatry, primary care, and oncology. Studies were conducted across diverse ambulatory primary and secondary care settings in North America, Europe and Australasia. A total of 49,785 patients were included across all the studies. The certainty of the evidence varied between very low and moderate. Many of the studies included in the review were at risk of performance and detection bias. The evidence suggests moderate certainty that PROMs feedback probably improves quality of life (standardised mean difference (SMD) 0.15, 95% confidence interval (CI) 0.05 to 0.26; 11 studies; 2687 participants), and leads to an increase in patient-physician communication (SMD 0.36, 95% CI 0.21 to 0.52; 5 studies; 658 participants), diagnosis and notation (risk ratio (RR) 1.73, 95% CI 1.44 to 2.08; 21 studies; 7223 participants), and disease control (RR 1.25, 95% CI 1.10 to 1.41; 14 studies; 2806 participants). The intervention probably makes little or no difference for general health perceptions (SMD 0.04, 95% CI -0.17 to 0.24; 2 studies, 552 participants; low-certainty evidence), social functioning (SMD 0.02, 95% CI -0.06 to 0.09; 15 studies; 2632 participants; moderate-certainty evidence), and pain (SMD 0.00, 95% CI -0.09 to 0.08; 9 studies; 2386 participants; moderate-certainty evidence). We are uncertain about the effect of PROMs feedback on physical functioning (14 studies; 2788 participants) and mental functioning (34 studies; 7782 participants), as well as fatigue (4 studies; 741 participants), as the certainty of the evidence was very low. We did not find studies reporting on adverse effects defined as distress following or related to PROM completion., Authors' Conclusions: PROM feedback probably produces moderate improvements in communication between healthcare professionals and patients as well as in diagnosis and notation, and disease control, and small improvements to quality of life. Our confidence in the effects is limited by the risk of bias, heterogeneity and small number of trials conducted to assess outcomes of interest. It is unclear whether   many of these improvements are clinically meaningful or sustainable in the long term. There is a need for more high-quality studies in this area, particularly studies which employ cluster designs and utilise techniques to maintain allocation concealment., (Copyright © 2021 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.)

Background: EQ-5D health state utilities (HSU) are commonly used in health economics to compute quality-adjusted life years (QALYs). The EQ-5D, which is country-specific, can be derived directly or by mapping from self-reported health-related quality of life (HRQoL) scales such as the PROMIS-29 profile. The PROMIS-29 from the Patient Reported Outcome Measures Information System is a comprehensive assessment of self-reported health with excellent psychometric properties. We sought to find optimal models predicting the EQ-5D-5L crosswalk from the PROMIS-29 in the United Kingdom, France, and Germany and compared the prediction performances with that of a US model., Methods: We collected EQ-5D-5L and PROMIS-29 profiles and three samples representative of the general populations in the UK (n = 1509), France (n = 1501), and Germany (n = 1502). We used stepwise regression with backward selection to find the best models to predict the EQ-5D-5L crosswalk from all seven PROMIS-29 domains. We investigated the agreement between the observed and predicted EQ-5D-5L crosswalk in all three countries using various indices for the prediction performance, including Bland-Altman plots to examine the performance along the HSU continuum., Results: The EQ-5D-5L crosswalk was best predicted in France (nRMSE FRA  = 0.075, nMAE FRA  = 0.052), followed by the UK (nRMSE UK  = 0.076, nMAE UK  = 0.053) and Germany (nRMSE GER  = 0.079, nMAE GER  = 0.051). The Bland-Altman plots show that the inclusion of higher-order effects reduced the overprediction of low HSU scores., Conclusions: Our models provide a valid method to predict the EQ-5D-5L crosswalk from the PROMIS-29 for the UK, France, and Germany.

Background: PROMIS-29 is a new generic standardized questionnaire measuring self-reported health status. It was developed as part of the Patient Reported Outcome Measurement Information System (PROMIS) in the United States. The objective of this study was to carry out the psychometric validation of a French-language version of PROMIS-29 and to establish general population reference values for France., Methods: Quota sampling was conducted by an independent polling company (Ipsos) to obtain a general population sample (n=1,501) representative with regards to: gender, age, occupation, region, and population density of the place of residence. Data collected included the results of the questionnaires PROMIS-29 and Short Form Health Survey (SF-36), the presence of selected chronic diseases, and socio-demographic information., Results: The French PROMIS-29 demonstrated excellent factorial validity, confirming the 7-factor model of the original PROMIS-29. The use of modern measurement methods indicated that the PROMIS-29 scales satisfy the important characteristics of unidimensionality and, for five of the seven composite scales, invariance across age, educational level and gender. Gender and age specific (10-year intervals) reference values were generated for PROMIS-29 use in France., Conclusion: The French version of PROMIS-29 is a valid and reliable measure of self-reported health status in the French population. The instrument's sensitivity to change needs to be evaluated before its use in longitudinal studies can be recommended., (Copyright © 2018 Elsevier Masson SAS. All rights reserved.)

Purpose: Comparability of patient-reported outcome measures over different languages is essential to allow cross-national research. We investigate the comparability of the PROMIS Profile 29, a generic health-related quality of life measure, in general population samples in the UK, France, and Germany and present general population reference values., Methods: A web-based survey was simultaneously conducted in the UK (n = 1509), France (1501), and Germany (1502). Along with the PROMIS Profile 29, we collected sociodemographic information as well as the EQ-5D. We tested measurement invariance by means of multigroup confirmatory factor analysis (CFA). Differences in the health-related quality of life between countries were modeled by linear regression analysis. We present general population reference data for the included PROMIS domains utilizing plausible value imputation and quantile regression., Results: Multigroup CFA of the PROMIS Profile 29 showed that factor means are insensitive to potential measurement bias except in one item. We observed significant differences in patient-reported health between countries, which could be partially explained by the differences in overall ratings of health. The physical function and pain interference scales showed considerable floor effects in the normal population in all countries., Conclusions: Scores derived from the PROMIS Profile 29 are largely comparable across the UK, France, and Germany. Due to the use of plausible value imputation, the presented general population reference values can be compared to data collected with other PROMIS short forms or computer-adaptive tests.

Objectives: Investigate the effectiveness of a complex intervention aimed at improving the appropriateness of medication in older patients with multimorbidity in general practice., Design: Pragmatic, cluster randomised controlled trial with general practice as unit of randomisation., Setting: 72 general practices in Hesse, Germany., Participants: 505 randomly sampled, cognitively intact patients (≥60 years, ≥3 chronic conditions under pharmacological treatment, ≥5 long-term drug prescriptions with systemic effects); 465 patients and 71 practices completed the study., Interventions: Intervention group (IG): The healthcare assistant conducted a checklist-based interview with patients on medication-related problems and reconciled their medications. Assisted by a computerised decision support system, the general practitioner optimised medication, discussed it with patients and adjusted it accordingly. The control group (CG) continued with usual care., Outcome Measures: The primary outcome was a modified Medication Appropriateness Index (MAI, excluding item 10 on cost-effectiveness), assessed in blinded medication reviews and calculated as the difference between baseline and after 6 months; secondary outcomes after 6 and 9 months' follow-up: quality of life, functioning, medication adherence, and so on., Results: At baseline, a high proportion of patients had appropriate to mildly inappropriate prescriptions (MAI 0-5 points: n=350 patients). Randomisation revealed balanced groups (IG: 36 practices/252 patients; CG: 36/253). Intervention had no significant effect on primary outcome: mean MAI sum scores decreased by 0.3 points in IG and 0.8 points in CG, resulting in a non-significant adjusted mean difference of 0.7 (95% CI -0.2 to 1.6) points in favour of CG. Secondary outcomes showed non-significant changes (quality of life slightly improved in IG but continued to decline in CG) or remained stable (functioning, medication adherence)., Conclusions: The intervention had no significant effects. Many patients already received appropriate prescriptions and enjoyed good quality of life and functional status. We can therefore conclude that in our study, there was not enough scope for improvement., Trial Registration Number: ISRCTN99526053. NCT01171339; Results., Competing Interests: Competing interests: CM, FMG, CG, MB, SH, WEH, JR and LU report receiving grants from the German Federal Ministry of Education and Research, BMBF, grant number 01GK0702, during the course of the study. WEH reports other grants from Dosing, Heidelberg, during the course of the study; he received personal fees, non-financial support and other from Aqua Institute Göttingen; personal fees, non-financial support and other from Aspen Europe; personal fees and other from Diaplan; grants, personal fees, non-financial support and other from Actelion; personal fees and other from GSK GER/UK/Slovakia/France; personal fees from Thieme Verlag; personal fees and other from Daiichi Sankyo; personal fees and other from Bristol-Myers Squibb; personal fees and other from MSD Sharp & Dohme; personal fees and other from AstraZenica; personal fees and other from Boehringer; personal fees and other from Grünenthal; personal fees and other from KWHC; personal fees and other from Novartis; personal fees and other from Berlin-Chemie; grants, personal fees and other from Landesapothekerkammer BW; grants and other from BMBF (DZIF, ESTHER); grants, personal fees, non-financial support and other from BayerPharma; grants from CHIESI; personal fees and other from Doctrina Med; personal fees and other from GSK France, UK, Germany, Slovakai; personal fees, non-financial support and other from Pfizer; grants from Smooth ClinicalTrials; grants from Sumaya Biotec; grants from Klaus Tschira Stiftung; other from University Frankfurt; grants from Vaximm, outside the submitted work. FO, MvdA, JMV, RP and JAK have nothing to disclose., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

Background: Patient-reported measure (PRM) questionnaires were originally used in research to measure outcomes of intervention studies. They have now evolved into a diverse family of tools measuring a range of constructs including quality of life and experiences of care. Current health and social care policy increasingly advocates their use for embedding the patient voice into service redesign through new models of care such as person-centered coordinated care (P3C). If chosen carefully and used efficiently, these tools can help improve care delivery through a variety of novel ways, including system-level feedback for health care management and commissioning. Support and guidance on how to use these tools would be critical to achieve these goals., Objective: The objective of this study was to develop evidence-based guidance and support for the use of P3C-PRMs in health and social care policy through identification of PRMs that can be used to enhance the development of P3C, mapping P3C-PRMs against an existing model of domains of P3C, and integration and organization of the information in a user-friendly Web-based database., Methods: A pragmatic approach was used for the systematic identification of candidate P3C-PRMs, which aimed at balancing comprehensiveness and feasibility. This utilized a number of resources, including existing compendiums, peer-reviewed and gray literature (using a flexible search strategy), and stakeholder engagement (which included guidance for relevant clinical areas). A subset of those candidate measures (meeting prespecified eligibility criteria) was then mapped against a theoretical model of P3C, facilitating classification of the construct being measured and the subsequent generation of shortlists for generic P3C measures, specific aspects of P3C (eg, communication or decision making), and condition-specific measures (eg, diabetes, cancer) in priority areas, as highlighted by stakeholders., Results: In total, 328 P3C-PRMs were identified, which were used to populate a freely available Web-based database. Of these, 63 P3C-PRMs met the eligibility criteria for shortlisting and were classified according to their measurement constructs and mapped against the theoretical P3C model. We identified tools with the best coverage of P3C, thereby providing evidence of their content validity as outcome measures for new models of care. Transitions and medications were 2 areas currently poorly covered by existing measures. All the information is currently available at a user-friendly web-based portal (p3c.org.uk), which includes all relevant information on each measure, such as the constructs targeted and links to relevant literature, in addition to shortlists according to relevant constructs., Conclusions: A detailed compendium of P3C-PRMs has been developed using a pragmatic systematic approach supported by stakeholder engagement. Our user-friendly suite of tools is designed to act as a portal to the world of PRMs for P3C, and have utility for a broad audience, including (but not limited to) health care commissioners, managers, and researchers., (©Helen Lloyd, Hannah Wheat, Jane Horrell, Thavapriya Sugavanam, Benjamin Fosh, Jose M Valderas, James Close. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 14.02.2018.)

Patient-reported outcomes (PROs) are reports of the status of a patient's health condition that come directly from the patient. While PRO measures are a well-developed technology with robust standards in research, their use for informing healthcare decisions is still poorly understood. We review relevant examples of their application in the provision of healthcare and examine the challenges associated with implementing PROs in clinical settings. We evaluate evidence for their use and examine barriers to their uptake, and present an evidence-based framework for the successful implementation of PROs in clinical practice. We discuss current and future developments for the use of PROs in clinical practice, such as individualized measurement and computer-adaptive testing.

Purpose: The objective was to obtain a standardized evaluation of available prostate cancer-specific quality of life instruments used in patients with early-stage disease., Methods: We carried out systematic literature reviews in the PubMed database to identify manuscripts which contained information regarding either the development process or metric properties of prostate cancer-specific quality of life instruments. Each instrument was evaluated by two experts, independently, using the Evaluating Measures of Patient-Reported Outcomes (EMPRO) tool. An overall and seven attribute-specific EMPRO scores were calculated (range 0-100, worst to best): measurement model, reliability, validity, responsiveness, interpretability, burden and alternative forms., Results: Eight instruments and 57 manuscripts (2-15 per instrument) were identified. The Expanded Prostate Cancer Index Composite (EPIC) was the best rated (overall EMPRO score 83.1 points). Good results were also obtained by University of California Los Angeles-Prostate Cancer Index (UCLA-PCI), Patient-Oriented Prostate Utility Scale (PORPUS) and Prostate Cancer Quality of Life Instrument (PC-QoL) with 77.3, 70.5 and 64.8 points, respectively. These four instruments passed with distinction the validity and responsiveness evaluation. Insufficient reliability results were observed for UCLA-PCI and PORPUS., Conclusions: Current evidence supports the choice of EPIC, PORPUS or PC-QoL. Attribute-specific EMPRO results facilitate selecting the adequate instrument for every purpose. For longitudinal studies or clinical trials, where responsiveness is the priority, EPIC or PC-QoL should be considered. We recommend the PORPUS for economic evaluations because it allows cost-utility analysis, and EPIC short versions to minimize administration burden.

To systematically evaluate available health-related quality of life (HRQL) instruments for use in patients with heart failure (HF). Seven HF-specific HRQL questionnaires and associated studies of their metric properties were identified by systematic review: the Chronic Heart Failure Assessment Tool, the Cardiac Health Profile congestive heart failure, the Chronic Heart Failure Questionnaire (CHFQ), the Kansas City Cardiomyopathy Questionnaire (KCCQ), the Left Ventricular Disease Questionnaire (LVDQ), the Minnesota Living with Heart Failure Questionnaire (MLHFQ), and the Quality of Life in Severe Heart Failure Questionnaire. Each instrument was assessed by four experts using a standardized tool for evaluating patient-reported outcomes (EMPRO; scores from 0 to 100). Four questionnaires were given adequate scores (median >50) for the attribute "conceptual model." The LVDQ had the highest rated median for "reliability" (72.8). The CHFQ, the KCCQ, and the MLHFQ all got reasonable scores for "validity" (from 54.4 to 76.4). The reviewers rated the KCCQ the highest in terms of "sensitivity to change" (median 94.4). Only the CHFQ (50.0) and the KCCQ (72.2) received adequate scores for the "interpretability" attribute. The most highly rated instruments based on the overall EMPRO score were the KCCQ (64.4) and the MLHFQ (60.7), followed by the CHFQ (59.2). Based on the first systematic and reliable expert-based evaluation of available HF-specific HRQL questionnaires, the evidence seems to support the choice of the KCCQ, the MLHFQ, and the CHFQ over the others, which require further research on metric properties.

Background: The aim of this study was to perform a standardized and systematic evaluation of the available evidence on multi-item shoulder-specific patient-reported outcome measures that are applicable to a wide spectrum of disorders., Materials and Methods: A systematic review was conducted in PubMed to identify articles with information regarding the development process, metric properties, and administration issues of shoulder-specific patient-reported outcome measures. Two experts independently reviewed all the articles identified for one instrument and applied the EMPRO (Evaluating Measures of Patient Reported Outcomes) tool, which was designed to assess the quality of attributes in a standardized way. An overall EMPRO score and 6 attribute-specific scores were calculated (range, 0-100) to describe the quality of instrument performance., Results: We identified 11 instruments and 112 articles (2-30 articles per instrument). The American Shoulder and Elbow Surgeons (ASES) shoulder assessment, Simple Shoulder Test (SST), and Oxford Shoulder Score (OSS) were the best rated, with overall scores of 77.4 points, 72.6 points, and 69.7 points, respectively. They have been shown to be valid, reliable, and responsive, with a low administration burden. Acceptable results were also found for the Flexilevel Scale of Shoulder Function, Shoulder Pain and Disability Index, and Dutch Shoulder Disability Questionnaire, but some of their attributes need further evaluation., Conclusions: Current evidence supports the use of the ASES, SST, or OSS. We recommend the SST for longitudinal studies or clinical trials, the Dutch Shoulder Disability Questionnaire for clinical practice to minimize administration burden, and the ASES or OSS to discriminate among patients' or groups' evaluations at one point of time., (Copyright © 2014 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Mosby, Inc. All rights reserved.)

Purpose: We investigated the effect of parents' mental health, life events, and home life (among other factors) on adolescents'/youths' mental health, whether such an effect varies when several variables are assessed jointly, and also whether the informant source of the mental health problem modifies the estimations., Methods: We studied a representative sample of 454 Spanish adolescents/youths studied longitudinally (2 assessments, 3 years apart). We considered factors associated with adolescents'/youths' mental health (conduct, emotional, and hyperactivity scores [SDQ]): risk factors (parents' mental health and life events) and mediators (social and financial support). Structural equation modeling was applied. We constructed two models: (a) with parents' SDQ responses and (b) with self-reported SDQ responses (in a subsample of N = 260)., Results: Model fit was adequate for parents' appraisal. Parents' mental health (p < 0.05) and undesirable life events (p < 0.05) were the most important risk factors. The same model showed poorer fit when self-reported measures were used. Home life exerted a stronger protective effect on adolescents'/youths' mental health when reported by adolescents/youths. The negative effect of parents' mental health was significantly protected by home life in emotional [-0.14 (0.07)] and hyperactivity scores [-0.2 (0.08)]., Conclusions: Even in the presence of other factors, parents' mental health has an important effect on adolescents'/youths' mental health. Good levels of home life are protective, especially when adolescents'/youths' mental health is self-reported.

Background: Most studies on the effect of life events (LEs) have been carried out in convenience samples which cannot be considered representative of the general population. In addition, recent studies have observed that gender differences in the health related quality of life (HRQoL) impact of LEs might be lower than believed. We assessed the relationship between LEs and HRQoL in a representative sample of Spanish adolescents/youths, focusing on gender differences., Methods: Participants (n = 840) completed the KIDSCREEN-27 to measure HRQoL at baseline and again after 3 years (n = 454). Follow-up assessment included the Coddington Life Events Scales (CLES) to measure LEs experiences in the previous 12 months. Respondents were categorized according to the amount of stress suffered. We calculated both the number of LEs and the Life Change Unit (LCU) score, a summary of the amount of stress inherent to the event and the time elapsed since occurrence. LEs were classified as desirable or undesirable, and family-related or extra-family. Effect sizes were calculated to evaluate changes in HRQoL. To assess the impact of LEs typologies, multiple linear regression models were constructed to evaluate their effect on HRQoL., Results: Girls reported a mean 5.7 LEs corresponding to 141 LCUs, and boys 5.3 and 129, respectively. The largest impact of LEs on HRQoL was observed in the group of boys that reported to have lived more stress (third tertil of LCUs distribution). The linear association between LEs and HRQoL tended to be stronger among boys than girls, but the difference was not statistically significant. The effect on HRQoL was deemed important when undesirable events had been experienced. To have an important impact on HRQoL, 200 LCUs due to undesirable events were necessary in boys. In girls, slightly higher scores were necessary for a similar impact., Conclusions: A moderate association was found between recent LEs and HRQoL, mainly among those who experienced several undesirable events that correspond to at least 200 LCUs. No gender differences were found in this association. Results may be useful for identifying adolescents with particular health risks, regardless of gender.

The Spanish KIDSCREEN follow-up study reassessed the Spanish baseline sample (n=840) of the European KIDSCREEN study 3 years later (2006). The aims of this paper were to describe the KIDSCREEN follow-up study and the pilot test, and to analyze participation rates and representativeness. Instruments included the KIDSCREEN-52 HRQoL measure and a set of scales including the possible explanatory variables. Focus groups and individual interviews were carried out in a pilot test. Participants were compared with non-participants at baseline, and also with Eurostat census data. Twenty-two out of 24 subjects were interviewed in the pilot test. Fifteen items needed to be modified after the pilot test. Participation rate reached 54% (n=454). Participants (mean age=12.71 years old) were on average 6 months younger than non-participants (p=0.03), and from more educated families. KIDSCREEN follow-up instrumentation seems adequate for collecting factors with potential influence on HRQoL. Follow-up respondents' representativeness seems to be acceptable., (Copyright (c) 2009 The Association for Professionals in Services for Adolescents. Published by Elsevier Ltd. All rights reserved.)

Background: The objective of the study was to assess the effect of changes in mental health status on health-related quality of life (HRQOL) in children and adolescents aged 8 - 18 years., Methods: A representative sample of Spanish children and adolescents aged 8-18 years completed the self-administered KIDSCREEN-52 questionnaire at baseline and after 3 years. Mental health status was measured using the Strengths and Difficulties Questionnaire (SDQ). Changes on SDQ scores over time were used to classify respondents in one of 3 categories (improved, stable, worsened). Data was also collected on gender, undesirable life events, and family socio-economic status. Changes in HRQOL were evaluated using effect sizes (ES). A multivariate analysis was performed to identify predictors of poor HRQOL at follow-up., Results: Response rate at follow-up was 54% (n = 454). HRQOL deteriorated in all groups on most KIDSCREEN dimensions. Respondents who worsened on the SDQ showed the greatest deterioration, particularly on Psychological well-being (ES = -0.81). Factors most strongly associated with a decrease in HRQOL scores were undesirable life events and worsening SDQ score., Conclusions: Changes in mental health status affect children and adolescents' HRQOL. Improvements in mental health status protect against poorer HRQOL while a worsening in mental health status is a risk factor for poorer HRQOL.

Objectives: To assess changes in health-related quality of life (HRQoL) in children and adolescents over a 3-year period and to examine factors associated with change., Methods: A representative sample of Spanish children and adolescents aged 8-18 years and their parents completed the KIDSCREEN-52 questionnaire at baseline and again after 3 years. Data were also collected on gender, pubertal development (PD), and family socio-economic status (SES). Change in HRQOL over time was evaluated using effect sizes (ES). Generalized estimating equations (GEE) were used to analyze associations among changes in KIDSCREEN scores, socio-demographic factors, and pubertal development., Results: Response rate at follow-up was 54% (n = 454). Overall, HRQoL worsened in eight out of the ten KIDSCREEN dimensions, with ES ranging from -0.10 (Moods and Emotions) to -0.34 (Psychological Well-being). The decrease was most marked in the intermediate age group (13-17 years of age at follow-up) and in girls. In the GEE models, pubertal development more strongly impacted changes in girls than in boys., Conclusions: In this representative, population-based sample of children and adolescents, moderate decrements in HRQoL were observed after 3 years. Changes were particularly important among girls and in relation to pubertal development. These results could provide useful reference data for other longitudinal studies in population sub-groups.

Objective: This study was aimed to develop a tool for the standardized assessment of patient-reported outcomes (PROs) to assist the choice of instruments., Methods: An expert panel adapted the eight attributes proposed by the Medical Outcomes Trust as evaluation review criteria, created items to evaluate them, and included a response scale for each item. A pilot test was designed to test the new tool's feasibility and to obtain preliminary information concerning its psychometric properties. The Spanish versions of five measures were selected for assessment: the SF-36 Health Survey, the Nottingham Health Profile, the COOP-WONCA charts, the EuroQol-5D, and the Quality of Life Questionnaire EORTC-QLQ-C30. We assessed the new tool's reliability (Cronbach's alpha and intraclass correlation coefficient [ICC]) and construct validity., Results: The new EMPRO (Evaluating the Measurement of Patient-Reported Outcomes) tool has 39 items covering eight key attributes: conceptual and measurement model, reliability, validity, responsiveness, interpretability, burden, alternative modes of administration, and cross-cultural and linguistic adaptations. Internal consistency was high (alpha = 0.95) as was interrater concordance (ICC: 0.87-0.94). Positive associations consistent with a priori hypotheses were observed between EMPRO attribute scores and the number of articles identified for the measures, the years elapsed since the publication of the first article, and the number of citations., Conclusion: A new tool for the standardized assessment of PRO measures is available. It has shown good preliminary reliability and validity and should be a useful aid to investigators who need to choose between alternative measures. Further assessment of the tool is necessary.

Background and Objective: The SF-36 is one of the most widely evaluated and used quality of life questionnaires. Two summary components (physical and mental) have been developed from its 8 original dimensions. The objective of this study was to obtain the Spanish weights to calculate the summary components of the SF-36 and the SF-12, to evaluate their metric characteristics, and to obtain general population based reference norms., Material and Method: Representative samples of the Spanish population gathered from 2 cross-sectional studies: <> (n = 9151) and <> (n = 3,004). The Spanish weights of the summary components of SF-36 and SF-12 were calculated by principal component analysis and multiple linear regressions, respectively. Known groups were compared to evaluate construct validity and reliability was assessed with internal consistency coefficients., Results: The Spanish weights obtained were very similar to those of the original American version (correlation > 0.9). The SF-12 items explained a 91% of the variance of SF-36 summary components. All the scores were lower (worse) in the elderly and most underprivileged groups (p < 0.001). Internal consistency coefficients were close to 0.9 for the SF-36, and slightly lower for the SF-12., Conclusions: Physical and mental summary components estimated with Spanish weights are reliable and valid. The Spanish general population based norms of these summaries will facilitate the interpretation of quality of life results assessed with the SF family of questionnaires in Spanish studies.

Objective: The purpose of this paper is to summarize the best evidence regarding the impact of providing patient-reported outcomes (PRO) information to health care professionals in daily clinical practice., Methods: Systematic review of randomized clinical trials (Medline, Cochrane Library; reference lists of previous systematic reviews; and requests to authors and experts in the field)., Results: Out of 1,861 identified references published between 1978 and 2007, 34 articles corresponding to 28 original studies proved eligible. Most trials (19) were conducted in primary care settings performed in the USA (21) and assessed adult patients (25). Information provided to professionals included generic health status (10), mental health (14), and other (6). Most studies suffered from methodologic limitations, including analysis that did not correspond with the unit of allocation. In most trials, the impact of PRO was limited. Fifteen of 23 studies (65%) measuring process of care observed at least one significant result favoring the intervention, as did eight of 17 (47%) that measured outcomes of care., Conclusions: Methodological concerns limit the strength of inference regarding the impact of providing PRO information to clinicians. Results suggest great heterogeneity of impact; contexts and interventions that will yield important benefits remain to be clearly defined.

Quality-of-life (QOL) instruments used in clinical research can provide important evidence to inform decisions about alternative treatments. This is particularly true when patients, such as those with cancer who are contemplating toxic chemotherapy, face tradeoffs between quantity of life and QOL or when the primary goal of therapy is to improve how patients feel. Surrogate measures (cardiac function, exercise capacity, bone density, tumor size) are inadequate substitutes for direct measurement of QOL. Quality-of-life measures will be most valuable when they comprehensively measure aspects of QOL that are both important to patients and likely to be influenced by therapy, when the QOL measurement instruments are valid (measuring what is intended) and responsive (able to detect all important changes, even if small), and when the results are readily interpretable (determining whether treatment-related changes are trivial, small but important, or large). Researchers are finding new, imaginative ways to help clinicians understand the magnitude of treatment impact on QOL. Additionally, QOL measures may be useful in clinical practice. Recent results from well-designed randomized controlled trials suggest that information on patient QOL provided to clinicians might, in some circumstances, result in benefits for these patients. Further investigation is warranted to confirm these observations and to define the particular combination of methods and settings most likely to yield important benefits.

In the last few years, many different instruments assessing health-related quality of life and the broader concept of Patient-Reported Outcomes (PRO) have been developed. Following the recommendations of the Scientific Advisory Committee of the Medical Outcomes Trust, the ePRO checklist provides a modular assessment for PRO instruments based on eight key attributes: conceptual and measurement model, reliability, validity, responsiveness, interpretability, respondent and administrative burden, alternative forms, and cross-cultural adaptation. Selected criteria describing each attribute in detail are also listed. The availability of explicit guidelines is expected to promote the development of better PRO measurement instruments.

Background: Evidence about the impact of routine feedback of patient-reported outcomes is contradictory, and there is limited information regarding its use in the routine management of cataract patients., Methods: The VF-14 Index was used to assess the visual function of 833 consecutive cataract patients, attending 19 ophthalmologists from public and private hospitals and primary care practices in Spain, in 1999-2000. In this before/after trial, the intervention included (1) an educational session, and (2) the provision of the VF-14 scores of all subsequent patients to the ophthalmologist. Mixed effects linear and logistic models were constructed to assess the effect on the process (correlation between patients' and physicians' assessments of visual function, appropriateness of surgery recommendation) and the outcome of care (satisfaction)., Results: The adjusted regression coefficient for the VF-14 score significantly increased after the intervention as a predictor of the ophthalmologist's assessment of visual function (beta coefficient: control 0.10 vs. intervention 0.35, p < 0.05). The intervention did not increase the probability of an appropriate medical decision (OR = 0.90; 95% CI: 0.42; 2,69) and it did not change patient satisfaction with care., Conclusions: Routine provision of education and feedback on the patient's VF-14 Index score significantly increases agreement between patients' and physicians' assessments of functional capacity. The lack of a beneficial effect on management or outcome suggests the need for a more intense intervention to change medical practice.

Objective: The Short Form-36 Health Survey (SF-36) is one of the most widely used and evaluated generic health-related quality of life (HRQL) questionnaires. After almost a decade of use in Spain, the present article critically reviews the content and metric properties of the Spanish version, as well as its new developments., Methods: A review of indexed articles that used the Spanish version of the SF-36 was performed in Medline (PubMed), the Spanish bibliographic databases IBECS and IME. Articles that provided information on the measurement model, reliability, validity, and responsiveness to change of the instrument were selected., Results: Seventy-nine articles were found, of which 17 evaluated the metric characteristics of the questionnaire. The reliability of the SF-36 scales was higher than the suggested standard (Cronbach's alpha) of 0.7 in 96% of the evaluations. Grouped evaluations obtained by meta-analysis were higher than 0.7 in all cases. The SF-36 showed good discrimination among severity groups, moderate correlations with clinical indicators, and high correlations with other HRQL instruments. Moreover, questionnaire scores predicted mortality and were able to detect improvement due to therapeutic interventions such as coronary angioplasty, benign prostatic hyperplasia surgery, and non-invasive positive pressure home ventilation. The new developments (norm-based scoring, version 2, the SF-12 and SF-8) improved both the metric properties and interpretation of the questionnaire., Conclusions: The Spanish version of the SF-36 and its recently developed versions is a suitable instrument for use in medical research, as well as in clinical practice.

Background: In spite of a well-established development of instruments, difficulty in interpreting health related quality of life scores may limit its use in clinical practice., Objective: To develop generalizable interpretation aids for a measure of perceived functional visual status, the VF-14 index., Design: Item Response Theory (Rasch analysis) was used to analyze the performance of VF-14 items. The 'ruler' aid was derived from the most difficult activity (item) a patient is able to do without difficulty; the 'clinical scenarios' aid, first identified all significantly different clusters of items within the index and then estimated the mean expected difficulty (responses) to perform a benchmark item in each cluster., Setting: The study was conducted in four hospitals and six ambulatory cataract surgery centers in Barcelona, Spain., Patients: One hundred and ninety-eight patients scheduled for first eye cataracts surgery., Measurements: The self-reported VF-14 index and clinical measures were used., Results: All VF-14 items were found unidimensional with three items showing only partial misfit. For a patient with a VF-14 Rasch score of 71, the 'ruler' aid indicated that 'doing fine handwork' would be the most requiring activity he/she would perform without difficulty. The 'clinical scenarios' aid estimated that such a patient would be unable to 'drive at night', would have some difficulty 'reading small print' and no difficulty 'doing fine handwork', 'watching TV' or 'recognizing people'. Concordance between modeled and observed responses was fair to substantial., Conclusions: Simple content-based interpretation aids for the VF-14 scores were developed that should facilitate its use in clinical practice. These aids should be easily generalizable to other quality of life instruments.

Jonathan P Evans,1 Alexander Smith,2 Chris Gibbons,3 Jordi Alonso,4–6 Jose M Valderas1 1Health Services and Policy Research Group, University of Exeter Medical School, Exeter, UK; 2Aneurin Bevan University Health Board, Clinical Research and Innovation Centre, St Woolos Hospital, Newport, UK; 3Patient-Reported Outcomes, Value and Experience (PROVE) Center Brigham and Women’s Hospital, Harvard Medical School, Boston, MA, USA; 4IMIM-Hospital del Mar Medical Research Institute, Barcelona, Spain; 5Pompeu Fabra University (UPF), Barcelona, Spain; 6CIBER en Epidemiología y Salud Pública (CIBERESP), Barcelona, Spain Abstract: The interest in patient-reported outcome measures (PROMs) continues to increase as recognition of their potential utility rises in an effort to make health systems more patient-centered. The US National Institutes of Health (NIH) Patient-Reported Outcomes Measurement Information System® (PROMIS®) has used state of the art psychometric and statistical techniques to create a universal PROMs language, with potential application across the whole spectrum of health conditions, languages, and geographic locations. PROMIS offers a versatile platform where specific health domains are assessed using both standardized short forms and computerized adaptive tests, which are automatically tailored to individual patients. The scores of each health domain or a standardized profile of multiple domains are all scored on a common metric scale. PROMIS is increasingly recognized as the international gold standard for patient-centered assessment, although the use of these tools in the UK is limited. In this review, the developmental methodology of the PROMIS is described with discussion of its relevant strengths and limitations for use in the UK. We provide a case study of the largest application of the PROMIS tools in the UK as an example of straightforward integration into health-care research. Barriers to the uptake of PROMIS in the UK include the technology requirement, measurement tradition, and lack of a clear understanding of its benefits, and although potential stakeholders should cautiously consider its use, its impressive potential and increasing international utilization should be recognized. Keywords: outcomes, patient reported outcomes, quality of life, health-related quality of life, PROMIS