Development and Validation of the Keele Musculoskeletal Patient Reported Outcome Measure (MSK-PROM).
ABSTRACT: To develop and validate a patient report outcome measure (PROM) for clinical practice that can monitor health status of patients with a range of musculoskeletal (MSK) disorders.Constructs for inclusion in the MSK-PROM were identified from a consensus process involving patients with musculoskeletal conditions, clinicians, purchasers of healthcare services, and primary care researchers. Psychometric properties of the brief tool, including face and construct validity, repeatability and responsiveness were assessed in a sample of patients with musculoskeletal pain consulting physiotherapy services in the United Kingdom (n=425).The consensus process identified 10 prioritised domains for monitoring musculoskeletal health status: pain intensity, quality of life, physical capacity, interference with social/leisure activities, emotional well-being, severity of most difficult thing, activities and roles, understanding independence, and overall impact. As the EuroQol (EQ-5D-5L) is a widely adopted PROMs tool and covers the first four domains listed, to reduce patient burden to a minimum the MSK-PROM was designed to capture the remaining six prioritised domains which are not measured by the EQ-5D-5L. The tool demonstrated excellent reliability, construct validity, responsiveness and acceptability to patients and clinicians for use in clinical practice.We have validated a brief patient reported outcome measure (MSK-PROM) for use in clinical practice to measure musculoskeletal health status and monitor outcomes over time using domains that are meaningful to patients and sensitive to change. Further work will establish whether the MSK-PROM is useful in other musculoskeletal healthcare settings.
Project description:People with hemophilia (PWH) experience frequent joint bleeding, resulting in pain and functional impairment. Generic and disease-specific patient-reported outcome (PRO) instruments have been used in clinical studies, but rarely in the comprehensive hemophilia care setting.The objective of this study was to assess construct validity of PRO instruments measuring pain, functional impairment, and health-related quality of life in US PWH with a history of joint pain/bleeding.Adult male PWH completed 4 PRO instruments (EQ-5D-5L with visual analog scale, Brief Pain Inventory v2 Short Form [BPI], SF-36v2, Hemophilia Activities List [HAL]) and underwent a musculoskeletal examination (Hemophilia Joint Health Score v2.1 [HJHS]). Construct validity between index and domain scores was evaluated by Pearson product-moment correlation coefficient.A total of 381 PWH were enrolled. EQ-5D-5L Mobility correlated with BPI, SF-36v2, and HAL domains related to pain, physical function, and activity of the lower extremities. EQ-5D-5L Self-Care correlated only with HAL Self-Care. EQ-5D-5L Usual Activities correlated with BPI Pain Interference and domains within SF-36v2 and HAL related to pain and physical function/activities (particularly those involving the lower extremities). EQ-5D-5L Pain/Discomfort correlated with Bodily Pain and Physical Summary on SF-36v2, HAL Overall Activity, and all BPI pain domains. EQ-5D-5L Anxiety/Depression correlated with social/emotional/mental aspects of SF-36v2. On BPI, most pain domains correlated with Bodily Pain and Physical Health Summary on SF-36v2 and Overall Activity on HAL. On SF-36v2, Physical Functioning, Role Physical, Bodily Pain, and Physical Health summary scores correlated with all the domains of HAL except Self-Care. For HJHS, Ankle and Total scores correlated with SF-36v2 Physical Functioning and HAL Lying/Sitting, Leg Function, Complex Lower Extremity Activity, and Overall Activity.All PRO instruments have high construct validity but provide different levels of detail in describing effects of hemophilia. Instrument choice may depend on individuals' symptoms, treatment planning goals, or outcome tracking research objectives, with consideration for administrative burden.
Project description:OBJECTIVES:We have previously developed and validated the Arthritis Research UK Musculoskeletal Health Questionnaire (MSK-HQ) for use across musculoskeletal care pathways, showing encouraging psychometric test results. The objective of this study was to determine the responsiveness of MSK-HQ following MSK treatments and to determine the minimally important change (MIC). SETTING:We collected data in four cohorts from community physiotherapy and secondary-care orthopaedic hip, knee and shoulder clinics. PARTICIPANTS:592 individuals were recruited; 210 patients treated with physiotherapy for a range of MSK conditions in primary care; 150 patients undergoing hip replacement, 150 patients undergoing knee replacement and 82 undergoing shoulder surgery in secondary care. OUTCOME MEASURES:Preoperative data were collected including the MSK-HQ, European Quality of Life-5D (EQ-5D) and the OHS, OKS or OSS in each joint-specific group. The same scores, together with anchor questions, were collected postintervention at 3 months for the physiotherapy group and 6 months for all others. Following COnsensus-based Standards for the selection of health status Measurement INstruments (COSMIN) guidelines, responsiveness was assessed using correlation between scores and the MIC was calculated for the entire cohort using receiver operating characteristic curve analysis. RESULTS:The MSK-HQ demonstrated strong correlation (R=0.73) with EQ-5D across the entire cohort and with each of the joint-specific Oxford scores (hip R=0.87, knee R=0.92 and shoulder R=0.77). Moderate correlation was seen between MSK-HQ and EQ-5D across each individual group (R value range 0.60-0.68), apart from the hip group where correlation was strong (R=0.77). The effect size with MSK-HQ was 0.93, in the entire cohort, double that measured with EQ-5D (0.43). In all subgroups, MSK-HQ measured a greater treatment effect compared with EQ-5D. The MIC is 5.5 (95% CI 2.7 to 8.3). CONCLUSION:Our study demonstrates that the MSK-HQ questionnaire is responsive to change across a range of musculoskeletal conditions, supporting its use as a generic MSK measurement instrument.
Project description:This is a prospective study to establish prediction models that map the refined Scoliosis Research Society 22-item (SRS-22r) onto EuroQoL-5 dimension 5-level (EQ-5D-5L) utility scores in adolescent idiopathic scoliosis (AIS) patients. Comparison of treatment outcomes in AIS can be determined by cost-utility analysis. However, the mainstay spine-specific health-related quality of life outcome measure, the SRS-22r questionnaire does not provide utility assessment. In this study, AIS patients were prospectively recruited to complete both the EQ-5D-5L and SRS-22r questionnaires by trained interviewers. Ordinary least squares regression was undertaken to develop mapping models, which the validity and robustness were assessed by using the 10-fold cross-validation procedure. EQ-5D-5L utility scores were regressed on demographics, Cobb angle, curve types, treatment modalities, and five domains of the SRS-22r questionnaire. Three models were developed using stepwise selection method. EQ-5D-5L scores were regressed on 1) main effects of SRS-22r subscale scores, 2) as per 1 plus squared and interaction terms, and 3) as per 2 plus demographic and clinical characteristics. Model goodness-of-fit was assessed using R-square, adjusted R-square, and information criteria; whereas the predictive performance was evaluated using root mean square error (RMSE), mean absolute error (MAE), and the proportion of absolute error within the threshold of 0.05 and 0.10. A total of 227 AIS patients with mean age of 15.6 years were recruited. The EQ-5D-5L scores were predicted by four domains of SRS-22r (main effects of 'Function', 'Pain', 'Appearance' and 'Mental Health', and squared term of 'Function' and 'Pain'), and Cobb angle in Model 3 with the best goodness-of-fit (R-square/adjusted R-square: 62.1%/60.9%). Three models demonstrated an acceptance predictive performance in error analysis applying 10-fold cross-validation to three models where RMSE and MAE were between 0.063-0.065 and between 0.039-0.044, respectively. Model 3 was therefore recommended out of three mapping models established in this paper. To our knowledge, this is the first study to map a spine-specific health-related quality of life measure onto EQ-5D-5L for AIS patients. With the consideration and incorporation of demographic and clinical characteristics, over 60% variance explained by mapping model 3 enabled the satisfactory prediction of EQ-5D-5L utility scores from existing SRS-22r data for health economic appraisal of different treatment options.
Project description:PURPOSE:The validity and responsiveness of the EQ-5D-3L in visual conditions has been questioned, inspiring development of a vision 'bolt-on' domain (EQ-5D-3L?+?VIS). Developments in preference-based measures (PBM) also includes the EQ-5D-5L and the ICECAP-O capability wellbeing measure. This study aimed to examine the construct validity and responsiveness of the EQ-5D-3L, EQ-5D-5L, EQ-5D-3L?+?VIS and ICECAP-O in cataract surgery patients for the first time, to inform choice of PBM for economic evaluation in this population. METHODS:The analyses used data from the UK Predict-CAT cataract surgery cohort study. PBMs and the Cat-PROM5 [a validated measure of cataract quality of life (QOL)] were completed before surgery and 4-8 weeks after. Construct validity was assessed using correlations and known-group differences evaluated using regression. Responsiveness was evaluated using effect sizes and analysis of variance to compare change scores between groups, defined by patient-reported and clinical outcomes. RESULTS:The sample comprised 1315 patients at baseline. No PBMs were associated with visual acuity and only the ICECAP-O (Spearman's rs?=??-?0.35), EQ-5D-3L?+?VIS (rs?=??-?0.42) and EQ-5D-5L (Value Set for England rs?=??-?0.31) correlated at least moderately with the Cat-PROM5. Effect sizes of change were consistently largest for the EQ-5D-3L?+?VIS (range 0.34-0.41), followed by the ICECAP-O (range 0.20-0.34). Results indicated no improvement in responsiveness using the EQ-5D-5L (range 0.13-0.16) compared to the EQ-5D-3L (range 0.17-0.20). CONCLUSIONS:Whilst no PBMs comprehensively demonstrated evidence of construct validity and responsiveness in cataract surgery patients, the ICECAP-O was the most responsive generic PBM to improvements in QOL. Surprisingly the EQ-5D-5L was not more responsive than the EQ-5D-3L in this setting.
Project description:BACKGROUND:The EuroQol-5 Dimension (EQ-5D), developed in 1990, is a most widely used generic tool to measure the health-related quality of life (HRQoL) and considered suitable for patients with asthma. In 2009, the EuroQol Group developed a new EQ-5D version to overcome limitations related to its consistently reported high ceiling effect. To enhance the sensitivity for assessing the HRQoL in further patient populations, the number of responses of EQ-5D was increased from 3 to 5 levels (EQ-5D-5L). Moreover, the availability of well-defined requirements for its Web-based administration allows EQ-5D-5L use to monitor the HRQoL in electronic health (eHealth) programs. No study has evaluated the metric properties of the new EQ-5D-5L in patients with asthma yet. OBJECTIVE:This study aims to examine the distribution, construct validity, and reliability of the new EQ-5D-5L questionnaire administered online to adults with asthma. METHODS:We evaluated patients with asthma (age: 18-40 years) from a primary care setting in France and England, who self-completed the EQ-5D-5L questionnaire online. The inclusion criteria were persistent asthma defined as >6 months of prescribed inhaled corticosteroids and long-acting beta-agonists or inhaled corticosteroids alone during the 12 months prior to inclusion. The EQ-5D index was obtained by applying the English preference value set for the new EQ-5D-5L and the French 3L-5L crosswalk value set. Both value sets produced single preference-based indices ranging from 1 (best health state) to negative values (health states valued as worse than death), where 0=death, allowing the calculation of quality-adjusted life years. Responses to dimensions and index distribution, including ceiling and floor effects, were examined. The construct validity was assessed by comparing the means of known groups by analyses of variance and calculation of effect sizes. RESULTS:Of 312 patients answering the baseline Web-based survey, 290 completed the EQ-5D-5L (93%). The floor effect was null, and the ceiling effect was 26.5% (74/279). The mean EQ-5D-5L index was 0.88 (SD 0.14) with the English value set and 0.83 (SD 0.19) with the French 3L-5L crosswalk value set. In both indices, large effect sizes were observed for known groups defined by the Asthma Control Questionnaire (1.06 and 1.04, P<.001). Differences between extreme groups defined by chronic conditions (P=.002 and P=.003 for the English value set and French 3L-5L crosswalk value set, respectively), short-acting beta-agonists (SABAs) canisters in the last 12 months (P=.02 and P=.03), or SABA use during the previous 4 weeks (P=.03 and P=.01) were of moderate magnitude with effect sizes around 0.5. CONCLUSIONS:The new EQ-5D-5L questionnaire has an acceptable ceiling effect, a good construct validity based on the discriminant ability for distinguishing among health-related known groups, and high reliability, supporting its adequacy for assessing the HRQoL in patients with asthma. EQ-5D-5L completion by most Web-based respondents supports the feasibility of this administration form.
Project description:BACKGROUND:The EQ-5D-3L and EQ-5D-5L are two generic health-related quality of life measures, which may be used in clinical and health economic research. They measure impairment in 5 aspects of health: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The aim of this study was to assess the performance of the EQ-5D-3L and EQ-5D-5L in measuring the self-reported health status of older patients with substantial multimorbidity and associated polypharmacy. METHODS:Between 2017 and 2019, we administered EQ-5D-3L and EQ-5D-5L to a subset of patients participating in the OPERAM trial at 6 months and 12 months after enrolment. The OPERAM trial is a two-arm multinational cluster randomised controlled trial of structured medication review assisted by a software-based decision support system versus usual pharmaceutical care, for older people (aged???70 years) with multimorbidity and polypharmacy. In the psychometric analyses, we only included participants who completed the measures in full at 6 and 12 months. We assessed whether responses to the measures were consistent by assessing the proportion of EQ-5D-5L responses, which were 2 or more levels away from that person's EQ-5D-3L response. We also compared the measures in terms of informativity, and discriminant validity and responsiveness relative to the Barthel Index, which measures independence in activities of daily living. RESULTS:224 patients (mean age of 77 years; 56% male) were included in the psychometric analyses. Ceiling effects reported with the EQ-5D-5L (22%) were lower than with the EQ-5D-3L (29%). For the mobility item, the EQ-5D-5L demonstrated better informativity (Shannon's evenness index score of 0.86) than the EQ-5D-3L (Shannon's evenness index score of 0.69). Both the 3L and 5L versions of EQ-5D demonstrated good performance in terms of discriminant validity, i.e. (out of all items of the EQ-5D-3L and EQ-5D-5L, the pain/discomfort and anxiety/depression items had the weakest correlation with the Barthel Index. Both the 3L and 5L versions of EQ-5D demonstrated good responsiveness to changes in the Barthel Index. CONCLUSION:Both EQ-5D-3L and EQ-5D-5L demonstrated validity and responsiveness when administered to older adults with substantial multimorbidity and polypharmacy who were able to complete the measures.
Project description:<h4>Background</h4>The 5-level EQ-5D (EQ-5D-5L) has been increasingly used in China to measure the health status of the general population and patients. However, its content validity among rural residents in China has not been formally evaluated. This qualitative study aims to assess the content validity of EQ-5D-5L among rural Chinese.<h4>Methods</h4>Participants were recruited from four regions (North, South, East and West) across China. Eligible participants were those living in the rural area in last three years and making a living by agricultural operations. Semi-structured interviews were conducted. Interview transcripts were analysed to assess the comprehensibility, relevance, clarity and comprehensiveness.<h4>Results</h4>Sixty-two participants were included, comparable to the national figures regarding age, sex and education. For comprehensibility, participants could understand the 'mobility', 'self-care' and 'usual activities' domains well, but some reported confusions in 'pain/discomfort' (n?=?42) and 'anxiety/depression' (n?=?35). Some also reported difficulties in understanding anxiety (n?=?6) and depression (n?=?9), possibly due to the formal wording used. For relevance, all domains were reported as health-related and participants' responses were based on their own health. For clarity, all could distinguish the five levels, but suggestions on reducing response levels and alternative wording for 'slight' were raised. For comprehensiveness, two aspects (fatigue/energy and appetite) were raised beyond the EQ-5D-5L domains. The 'mobility' domain was selected as the most important and 'anxiety/depression' as the least important.<h4>Conclusion</h4>Rural Chinese reported problems on the content validity of Chinese EQ-5D-5L. It might be sensible to consider some revisions to make it more understandable for rural residents.
Project description:The objective of this study is to obtain population norms and to assess test-retest reliability of EQ-5D-5L and WHOQOL-BREF for the Indonesian population.A representative sample of 1056 people aged 17-75 years was recruited from the Indonesian general population. We used a multistage stratified quota sampling method with respect to residence, gender, age, education level, religion and ethnicity. Respondents completed EQ-5D-5L and WHOQOL-BREF with help from an interviewer. Norms data for both instruments were reported. For the test-retest evaluations, a sub-sample of 206 respondents completed both instruments twice.The total sample and test-retest sub-sample were representative of the Indonesian general population. The EQ-5D-5L shows almost perfect agreement between the two tests (Gwet's AC: 0.85-0.99 and percentage agreement: 90-99%) regarding the five dimensions. However, the agreement of EQ-VAS and index scores can be considered as poor (ICC: 0.45 and 0.37 respectively). For the WHOQOL-BREF, ICCs of the four domains were between 0.70 and 0.79, which indicates moderate to good agreement. For EQ-5D-5L, it was shown that female and older respondents had lower EQ-index scores, whilst rural, younger and higher-educated respondents had higher EQ-VAS scores. For WHOQOL-BREF: male, younger, higher-educated, high-income respondents had the highest scores in most of the domains, overall quality of life, and health satisfaction.This study provides representative estimates of self-reported health status and quality of life for the general Indonesian population as assessed by the EQ-5D-5L and WHOQOL-BREF instruments. The descriptive system of the EQ-5D-5L and the WHOQOL-BREF have high test-retest reliability while the EQ-VAS and the index score of EQ-5D-5L show poor agreement between the two tests. Our results can be useful to researchers and clinicians who can compare their findings with respect to these concepts with those of the Indonesian general population.
Project description:OBJECTIVES:To determine the response process validity, feasibility of completion, acceptability and preferences for three patient-reported outcome measures that could be used in economic evaluation-the EQ-5D-5L, ICECAP-A and ICECAP-O-in people requiring kidney care. DESIGN:Participants were asked to 'think-aloud' while completing the EQ-5D-5L, ICECAP-A and ICECAP-O, followed by a semistructured interview. Five raters identified errors or struggles in completing the measures from the think-aloud component of the transcripts. Patient preferences for measures were extracted from the semistructured interview. SETTING:Eligible patients were identified through a large UK secondary care renal centre. PARTICIPANTS:In total, 30 participants were included in the study, consisting of patients attending renal outpatients for chronic kidney disease (n=18), with a functioning kidney transplant (n=6) and receiving haemodialysis (n=6). RESULTS:Participants had few errors and struggles in completing the EQ-5D-5L (11% error rate, 3% struggle rate), ICECAP-A (2% error rate, 2% struggle rate) and ICECAP-O (4% error rate, 3% struggle rate). The main errors with the EQ-5D-5L were judgements that did not comply with the 'your health today' instruction. Comprehension errors were most prominent on ICECAP-O. Judgement errors were the only errors reported on ICECAP-A. Although the EQ-5D-5L had slightly more errors and struggles, it was the measure most preferred, with participants able to make a clearer link with EQ-5D-5L and their health condition. CONCLUSIONS:The EQ-5D-5L, ICECAP-A and ICECAP-O are feasible for people requiring kidney care to complete and can be included in studies conducting economic evaluations of kidney care interventions. Further research is required to assess how health (eg, EQ-5D) and capability (eg, ICECAP) measures can be included in an economic evaluation simultaneously, as well as what ICECAP measure(s) to include when patient groups straddle the age ranges for ICECAP-A (18 years and older) and ICECAP-O (65 years and older).
Project description:The Patient Reported Outcomes Measurement Information System 43-item short form (PROMIS-43) and the five-level EQ-5D (EQ-5D-5L) are recently developed measures of health-related quality of life (HRQL) that have potentially broad application in evaluating treatments and capturing burden of respiratory-related diseases. The aims of this study were: (1) to examine their psychometric properties in patients with chronic obstructive pulmonary disease (COPD), and (2) to identify dimensions of HRQL that differ and do not differ by lung function.We conducted a multi-center, cross-sectional study ("COPD Outcomes-based Network for Clinical Effectiveness & Research Translation" [CONCERT]). We analyzed patients who met spirometric criteria for COPD, and completed EQ-5D-5L and PROMIS questionnaires. Disease severity was graded based on the Global Initiative for Chronic Obstructive Lung Disease (GOLD) classification. Pulmonary function test, PROMIS-43, EQ-5D (index score and EQ-Visual Analog Scale [EQ-VAS]), six minute walk test (6MWT), and three dyspnea scales (mMRC, Borg, FACIT-Dyspnea) were administered. Validity and reliability of EQ-5D-5L and PROMIS-43 were examined, and differences in HRQL by GOLD grade were assessed.Data from 670 patients with COPD were analyzed (mean age 68.5 years; 58% male). More severe COPD was associated with more problems with mobility, self-care and usual activities (all p-values <0.01) according to EQ-5D-5L. Related domains on EQ-5D-5L, PROMIS and clinical measures were moderately (r = 0.30-0.49) to strongly (r ? 0.50) correlated. A statistically significant trend of decreasing HRQL with more severe lung functions was observed for EQ-5D-5L index scores, EQ-VAS scores, and PROMIS physical function and social roles.Results supported the validity of EQ-5D-5L and PROMIS-43 in COPD patients, and indicate that physical function and social activities decrease with level of lung function by GOLD grade, but not pain, mental health, sleep or fatigue as reported by patients.