Project description:BACKGROUND:The Hip disability and Osteoarthritis Outcome Score (HOOS) is a frequently used patient-reported outcome measure (PROM) for assessment of hip disorders and treatment effects following hip surgery. The objective of the study was to translate and adapt the Hip disability and Osteoarthritis Outcome Score (HOOS) into Polish and to investigate the psychometric properties of the HOOS in patients with osteoarthritis undergoing total hip replacement (THR). MATERIALS AND METHODS:The Polish version of the HOOS was developed according to current guidelines. Patients completed the HOOS, Short Form 36 Health Survey (SF-36), the visual analogue scale (VAS) for pain and the global perceived effect (GPE) scale. Psychometric properties including interpretability (floor/ceiling effects), internal consistency (Cronbach's alpha), test-retest reliability (intra-class correlation coefficient, ICC), convergent construct validity (a priori hypothesized Spearman's correlations between the HOOS subscales, the generic SF-36 measure and the VAS for pain) and responsiveness (effect size, association between the HOOS and GPE scores) were analyzed. RESULTS:The study included 157 patients (mean age 66.8?years, 54% women). Floor effects were found prior to THR for the HOOS subscales Sports and Recreation and Quality of Life. The Cronbach's alpha was over 0.7 for all subscales indicating satisfactory internal consistency. The test-retest reliability was good for the HOOS subscale Pain (0.82) and excellent for all other subscales with ICCs ranging from 0.91 to 0.96. The minimal detectable change ranged from 12.0 to 26.2 on an individual level and from 1.4 to 3.0 on a group level. Seven out of eight a priori hypotheses were confirmed indicating good construct validity. Responsiveness was high since the expected pattern of effect sizes in all subscales was found. CONCLUSIONS:The Polish version of the HOOS demonstrated good reliability, validity and responsiveness for use in patient groups having THR.
Project description:BACKGROUND:Total hip replacement (THR)/total knee replacement (TKR) studies do not uniformly measure patient centered domains, pain, and function. We aim to validate existing measures of pain and function within subscales of standard instruments to facilitate measurement. METHODS:We evaluated baseline and 2-year pain and function for THR and TKR using Hip disability and Osteoarthritis Outcome Score (HOOS)/Knee Injury and Osteoarthritis Outcome Score (KOOS), with primary unilateral TKR (4796) and THR (4801). Construct validity was assessed by correlating HOOS/KOOS pain and activities of daily living (ADL), function quality of life (QOL), and satisfaction using Spearman correlation coefficients. Patient relevant thresholds for change in pain and function were anchored to improvement in QOL; minimally clinically important difference (MCID) corresponded to "a little improvement" and a really important difference (RID) to a "moderate improvement." Pain and ADL function scores were compared by quartiles using Kruskal-Wallis. RESULTS:Two-year HOOS/KOOS pain and ADL function correlated with health-related QOL (KOOS pain and Short Form 12 Physical Component Scale ? = 0.54; function ? = 0.63). Comparing QOL by pain and function quartiles, the highest levels of pain relief and function were associated with the most improved QOL. MCID for pain was estimated at ?20, and the RID ?29; MCID for function ?14, and the RID ?23. The measures were responsive to change with large effect sizes (?1.8). CONCLUSION:We confirm that HOOS/KOOS pain and ADL function subscales are valid measures of critical patient centered domains after THR/TKR, and achievable thresholds anchored to improved QOL. Cost-free availability and brevity makes them feasible, to be used in a core measurement set in total joint replacement trials.
Project description:ObjectiveTo create a translated version of the HOOS to fit the Italian population and to test its psychometric properties and validity in hip osteoarthritis (OA) patients undergoing total hip arthroplasty (THA).DesignThe HOOS Italian version was developed according to published international guidelines that include preparation, forward translation and reconciliation, backward translation, review and harmonization, and proof reading. The Italian HOOS was administered to 145 patients (mean age 65.7 ± 11.6 years, 34-89, 58.6% women) undergoing THA. The following psychometric properties were evaluated: internal consistency (Cronbach's alpha); test-retest reliability (Pearson's r and intra-class correlation coefficient, ICC); convergent validity (Spearman's rho between HOOS and SF-36); responsiveness (comparison of pre/post-THA scores, Wilcoxon signed rank test). Interpretability (floor and ceiling effects, skewness and kurtosis indexes) and acceptability (time to compiling, missing answers, and autonomy in compilation) were also evaluated.ResultsTranslation and transcultural adaptation were conducted in accordance with the international recommendation. The translation was deemed understandable and appropriate as to the transcultural adaptation. None of the patients reported to have met any difficulties in reading and understanding the HOOS items. Internal consistency and test-retest reliability were good for each HOOS subscale (Cronbach's alpha ≥0.7, Pearson's r and ICC > 0.80). Convergent validity showed the highest correlations (Spearman's rho > 0.5) between HOOS and SF-36 subscales relating to similar dimensions. As to responsiveness, all HOOS subscales scores improved significantly after THA (p < 0.01). Interpretability was acceptable despite ceiling effect in post-THA assessment. Acceptability was good: HOOS resulted easy and quick to fill out (12 min on average).ConclusionsThe HOOS was successfully cross-culturally adapted into Italian. The Italian HOOS showed good psychometric properties therefore it can be useful to assess outcomes in OA patients after THA. This study provided a basis for its use within the Italian Arthroplasty Registry and for future clinical trials.
Project description:BackgroundThe EQ-5D-5?L is a quality-of-life questionnaire based on individuals' preferences that is widely employed for cost-effectiveness analysis. Given the current demand for mapping algorithms to directly assign "utilities", this study aimed to generate different mapping models for predicting EQ-5D-5?L utility values based on scores of the Oxford Hip Score (OHS) and Oxford Knee Score (OKS) questionnaires provided by patients suffering from hip and knee osteoarthritis (OA), respectively, and to assess the predictive capability of these functions.MethodsThis was a prospective, observational study. Following the criteria of the American Rheumatism Association, 361 patients with hip OA and 397 with knee OA from three regions in Spain were included. Health-related quality of life (HRQoL) was assessed through the EQ-5D-5?L general questionnaire and the OHS and OKS specifically for lower limb OA. Based on the scores on the OHS and OKS questionnaires, EQ-5D-5?L utilities were estimated using 4 models: ordinary least squares (OLS), Tobit, generalized linear model (GLM), and beta regression (Breg). The models were validated on the same patients after 6?months: the mean absolute error (MAE) and mean squared error (MSE) with their 95% confidence intervals (CI), mean values of standard errors (SE), intraclass correlation coefficients (ICC), and Bland-Altman plots were obtained.ResultsThe lowest MAEs were obtained using GLM and Breg models, with values of 0.1103 (0.0993-0.1214) and 0.1229 (0.1102-0.1335) for hip OA, and values of 0.1127 (0.1014-0.1239) and 0.1141 (0.1031-0.1251) for knee OA. MSE values were also lower using GLM and Breg. ICCs between predicted and observed values were around or over the 0.8 cut-off point. Bland-Altman plots showed an acceptable correlation, but precision was lower for subjects with worse HRQoL, which was also evident when comparing MAEs of the bottom and top halves of the utilities scale. Predictive equations for utilities based on OHS/OKS scores were proposed.ConclusionsThe OHS and OKS scores allow for estimating EQ-5D-5?L utility indexes for patients with hip and knee OA, respectively, with adequate validity and precision. GLM and Breg produce the best predictions. The predictive power of proposed equations is more consistent for subjects in better health condition.
Project description:BackgroundThe degree to which a validated instrument is able to detect clinically significant change over time is an important issue for the better management of hip or knee replacement surgery. This study examines the internal responsiveness of the EQ-5D-3L, the Oxford Hip Score (OHS), and the Oxford Knee Score (OKS) by various methods. Data from NHS patient-reported outcome measures (PROMs) linked to the Hospital Episodes Statistics (HES) dataset (2009-2015) was analysed for patients who underwent primary hip surgery (N = 181,424) and primary knee surgery (N = 191,379).MethodsPaired data-specific univariate responsiveness was investigated using the standardized response mean (SRM), the standardized effect size (SES), and the responsiveness index (RI). Multivariate responsiveness was furthermore examined using the defined capacity of benefit score (i.e. paired data-specific MCID), adjusting baseline covariates such as age, gender, and comorbidities in the Box-Cox regression models. The observed and predicted percentages of patient improvement were examined both as a whole and by the patients' self-assessed transition level.ResultsThe results showed that both the OHS and the OKS demonstrated great univariate and multivariate responsiveness. The percentages of the observed (predicted) total improvement were high: 51 (54)% in the OHS and 73 (58)% in OKS. The OHS and the OKS showed distinctive differences in improvement by the 3-level transition, i.e. a little better vs. about the same vs. a little worse. The univariate responsiveness of the EQ-5D-3L showed moderate effects in total by Cohen's thresholds. The percentages of improvement in the EQ-5D-3L were moderate: 44 (48)% in the hip and 42 (44)% for the knee replacement population.ConclusionsDistinctive percentage differences in patients' perception of improvement were observed when the paired data-specific capacity of benefit score was applied to examine responsiveness. This is useful in clinical practice as rationale for access to surgery at the individual-patient level. This study shows the importance of analytic methods and instruments for investigation of the health status in hip and/or knee replacement surgery. The study finding also supports the idea of using a generic measure along with the disease-specific instruments in terms of cross-validation.
Project description:Background and Objectives: This study aimed to translate the Hip disability and Osteoarthritis Outcome Score (HOOS) into the Polish language, to determine its validity and reliability, and to assess its main psychometric properties. Materials and Methods: A total of 332 hip osteoarthritis (OA) subjects were recruited to the study group and 90 healthy subjects to the control group. The study consisted of the HOOS translation and the assessment of the discriminative power, internal consistency, and the potential floor and ceiling effects followed by the determination of the construct validity and test-retest reliability. The analysis was performed using Western Ontario and McMaster Universities osteoarthritis index (WOMAC) and SF-36 questionnaires. Results: The translation process consisted of forward translation, reconciliation, backward translation, review, harmonization, and proofreading. The hip OA patients reported a reduced HOOS score when compared to the control subjects. The discriminant validity of the questionnaire was confirmed. A Cronbach's alpha of 0.97 was found, indicating a high internal consistency. The HOOS showed a significant correlation with the SF-36 and WOMAC, which ranged from r = -0.93, p-value < 0.05 for WOMAC total score to r = 0.92, and p-value < 0.05 for WOMAC daily living. No floor or ceiling effects were found. A very high intraclass correlation coefficient (ICC) was found (0.93-0.97) for the total score and the individual domains of the HOOS. Conclusions: The Polish HOOS is valid and reliable for evaluating the outcomes of hip OA patients in Poland. This questionnaire may be used with confidence for clinical and research purposes.
Project description:Background and purpose - Total hip arthroplasty (THA) is performed mainly because of pain. To evaluate the result after surgery, different questionnaires measuring the patient-reported outcome regarding quality of life are used. Forgotten Joint Score (FJS), designed to chart postoperative symptoms, was developed to find subtle differences between patients who report that their operated hip is "very good" or "excellent." We evaluated whether FJS provides additional information compared with the Oxford Hip Score (OHS) and ceiling and floor effects with use of these instruments. We also studied level of internal consistency for OHS and FJS, and the reproducibility of the FJS. Patients and methods - 111 patients who underwent unilateral primary THA in 2015 were included. The participants answered 2 questionnaires: Forgotten Joint Score and Oxford Hip Score. Floor and ceiling effects were recorded for each of the instruments and agreement between them. The FJS was studied with respect to reproducibility and level of internal consistency. Results - OHS ceiling effect (31%) was higher compared with FJS (21%), whereas the OHS seemed to provide a more nuanced picture of patients with an inferior clinical result. Floor effect for FJS was 3% and 0% for OHS. The degree of explanation was 68% between the 2 questionnaires (linear regression, r2 = 0.68). FJS items had a high internal consistency (Cronbach's a = 0.93) and reproducibility (Pearson correlation = 0.87, ICC = 0.93); 92 patients answered on 2 distributions of the FJS questionnaires, 19 patients had identical answers. Interpretation - OHS had a larger ceiling effect than FJS, which could indicate that FJS is a more fine-tuned instrument to separate patients with good to excellent outcome after THA. The high internal consistency of FJS indicates that the items of the instrument consistently cover the construct of joint awareness.
Project description:PurposeTo develop a mapping model to estimate EQ-5D-3L from the Knee Injury and Osteoarthritis Outcome Score (KOOS).MethodsThe responses to EQ-5D-3L and KOOS questionnaires (n = 40,459 observations) were obtained from the Swedish National anterior cruciate ligament (ACL) Register for patients ≥ 18 years with the knee ACL injury. We used linear regression (LR) and beta-mixture (BM) for direct mapping and the generalized ordered probit model for response mapping (RM). We compared the distribution of the original data to the distributions of the data generated using the estimated models.ResultsModels with individual KOOS subscales performed better than those with the average of KOOS subscale scores (KOOS5, KOOS4). LR had the poorest performance overall and across the range of disease severity particularly at the extremes of the distribution of severity. Compared with the RM, the BM performed better across the entire range of disease severity except the most severe range (KOOS5 < 25). Moving from the most to the least disease severity was associated with 0.785 gain in the observed EQ-5D-3L. The corresponding value was 0.743, 0.772 and 0.782 for LR, BM and RM, respectively. LR generated simulated EQ-5D-3L values outside the feasible range. The distribution of simulated data generated from the BM model was almost identical to the original data.ConclusionsWe developed mapping models to estimate EQ-5D-3L from KOOS facilitating application of KOOS in cost-utility analyses. The BM showed superior performance for estimating EQ-5D-3L from KOOS. Further validation of the estimated models in different independent samples is warranted.
Project description:The aim of this work is to apply an integrated systems approach to understand the biological underpinnings of hip osteoarthritis that culminates in the need for total joint replacement (TJR). This study is a feasibility pilot that integrates functional genomics data from diseased and non-diseased tissues of OA patients who have undergone TJR. For each tissue, we characterised epigenetic marks (methylation), gene transcription (RNASeq) and expression (quantitative proteomics). We also generated genotype data on the HumanCoreExome array for each individual. This data is part of a pre-publication release.
Project description:PurposeIn order to enable cost-utility analysis of shoulder pain conditions and treatments, this study aimed to develop and evaluate mapping algorithms to estimate the EQ-5D health index from the Oxford Shoulder Score (OSS) when health outcomes are only assessed with the OSS.Methods5437 paired OSS and EQ-5D questionnaire responses from four national multicentre randomised controlled trials investigating different shoulder pathologies and treatments were split into training and testing samples. Separate EQ-5D-3L and EQ-5D-5L analyses were undertaken. Transfer to utility (TTU) regression (univariate linear, polynomial, spline, multivariable linear, two-part logistic-linear, tobit and adjusted limited dependent variable mixture models) and response mapping (ordered logistic regression and seemingly unrelated regression (SUR)) models were developed on the training sample. These were internally validated, and their performance evaluated on the testing sample. Model performance was evaluated over 100-fold repeated training-testing sample splits.ResultsFor the EQ-5D-3L analysis, the multivariable linear and splines models had the lowest mean square error (MSE) of 0.0415. The SUR model had the lowest mean absolute error (MAE) of 0.136. Model performance was greatest in the mid-range and best health states, and lowest in poor health states. For the EQ-5D-5L analyses, the multivariable linear and splines models had the lowest MSE (0.0241-0.0278) while the SUR models had the lowest MAE (0.105-0.113).ConclusionThe developed models now allow accurate estimation of the EQ-5D health index when only the OSS responses are available as a measure of patient-reported health outcome.