The responsiveness of the Manchester–Oxford Foot Questionnaire (MOXFQ) was compared with foot/ankle-specific and generic outcome measures used to assess all surgery of the foot and ankle. We recruited 671 consecutive adult patients awaiting foot or ankle surgery, of whom 427 (63.6%) were female, with a mean age of 52.8 years (18 to 89). They independently completed the MOXFQ, Short-Form 36 (SF-36) and EuroQol (EQ-5D) questionnaires pre-operatively and at a mean of nine months (3.8 to 14.4) post-operatively. Foot/ankle surgeons assessed American Orthopaedic Foot and Ankle Society (AOFAS) scores corresponding to four foot/ankle regions. A transition item measured perceived changes in foot/ankle problems post-surgery. Of 628 eligible patients proceeding to surgery, 491 (78%) completed questionnaires and 262 (42%) received clinical assessments both pre- and post-operatively. The regions receiving surgery were: multiple/whole foot in eight (1.3%), ankle/hindfoot in 292 (46.5%), mid-foot in 21 (3.3%), hallux in 196 (31.2%), and lesser toes in 111 (17.7%). Foot/ankle-specific MOXFQ, AOFAS and EQ-5D domains produced larger effect sizes (> 0.8) than any SF-36 domains, suggesting superior responsiveness. In analyses that anchored change in scores and effect sizes to patients’ responses to a transition item about their foot/ankle problems, the MOXFQ performed well. The SF-36 and EQ-5D performed poorly. Similar analyses, conducted within foot-region based sub-groups of patients, found that the responsiveness of the MOXFQ was good compared with the AOFAS.

This evidence supports the MOXFQ’s suitability for assessing all foot and ankle surgery.

Aims. Responsiveness and ceiling effects are key properties of an outcome score. No such data have been reported for the original English version of the International Hip Outcome Tool 12 (iHOT-12) at a follow-up of more than four months. The aim of this study was to identify the responsiveness and ceiling effects of the English version iHOT-12 in a series of patients undergoing hip arthroscopy for intra-articular hip pathology at a minimum of one year postoperatively. Methods. A total of 171 consecutive patients undergoing hip arthroscopy with a diagnosis of femoroacetabular impingement (FAI) under the care of a single surgeon between January 2013 and March 2017 were included. iHOT-12 and EuroQol 5D-5L (EQ-5D-5L) scores were available pre- and postoperatively. Effect size and ceiling effects for the iHOT-12 were calculated with subgroup analysis. Results. A total of 122 patients (71.3%) completed postoperative PROMs scores with median follow-up of 24.3 months (interquartile range (IQR) 17.2 to 33.5). The median total cohort iHOT-12 score improved significantly from 31.0 (IQR 20 to 58) preoperatively to 72.5 (IQR 47 to 90) postoperatively (p < 0.001). The effect size (Cohen’s d) was 1.59. In all, 33 patients (27%) scored within ten points (10%) of the maximum score and 38 patients (31.1%) scored within the previously reported minimal clinically important difference (MCID) of the maximum score. Furthermore, nine (47%) male patients aged < 30 years scored within 10% of the maximum score and ten (53%) scored within the previously reported MCID of the maximum score. Conclusion. There is a previously unreported ceiling effect of the iHOT-12 at a minimum one-year follow-up which is particularly marked in young, male patients following hip arthroscopy for FAI. This tool may not have the maximum measurement required to capture the true outcome following this procedure. Cite this article: Bone Joint J 2020;102-B(8):1010–1015

Objectives. To assess the responsiveness and ceiling/floor effects of the Forgotten Joint Score -12 and to compare these with that of the more widely used Oxford Hip Score (OHS) in patients six and 12 months after primary total hip arthroplasty. Methods. We prospectively collected data at six and 12 months following total hip arthroplasty from 193 patients undergoing surgery at a single centre. Ceiling effects are outlined with frequencies for patients obtaining the lowest or highest possible score. Change over time from six months to 12 months post-surgery is reported as effect size (Cohen’s d). Results. The mean OHS improved from 40.3 (. sd. 7.9) at six months to 41.9 (. sd. 7.2) at 12 months. The mean FJS-12 improved from 56.8 (. sd. 30.1) at six months to 62.1 (. sd. 29.0) at 12 months. At six months, 15.5% of patients reached the best possible score (48 points) on the OHS and 8.3% obtained the best score (100 points) on the FJS-12. At 12 months, this percentage increased to 20.8% for the OHS and to 10.4% for the FJS-12. In terms of the effect size (Cohen’s d), the change was d = 0.10 for the OHS and d = 0.17 for the FJS-12. Conclusions. The FJS-12 is more responsive to change between six and 12 months following total hip arthroplasty than is the OHS, with the measured ceiling effect for the OHS twice that of the FJS-12. The difference in effect size of change results in substantial differences in required sample size if aiming to detect change between these two time points. This has important implications for powering clinical trials with patient-reported measures as the primary outcome. Cite this article: Dr D. F. Hamilton. Responsiveness and ceiling effects of the Forgotten Joint Score-12 following total hip arthroplasty. Bone Joint Res 2016;5:87–91. DOI: 10.1302/2046-3758.53.2000480

Aim. To investigate the responsiveness to change of four different elbow-scoring instruments, two Hospital for Special Surgery (HSS) elbow assessment scales, the Mayo Clinic elbow-performance index (Mayo) and the Elbow Functional Assessment (EFA) scale. Methods. A group of 24 RA patients (median age 60 years) undergoing either elbow arthroplasty (22 elbows) or synovectomy with radial head excision (3 elbows), were evaluated both prior and after surgery (median: seven months postoperatively). Score changes, obtained by using the scales under study, were calculated. The patient’s opinion of global perceived effect of the intervention was used as a criterion to classify them as ‘improved’ or ‘non-changed’. Responsiveness was evaluated with use of three approaches: using paired t-statistics (pre- and post-surgery scores), effect size statistics (standardized response mean, effect size and responsiveness ratios) and Receiver Operator Characteristic (ROC) curves. Results. Each of the elbow rating measures under study proved to be responsive to change when evaluating RA patients undergoing elbow arthroplasty or synovectomy. The EFA scale demonstrated the highest power to detect a clinically meaningful difference and had the best discriminative ability to distinguish improved from non-changed patients, as was revealed by all responsiveness statistics applied. Conclusions. The HSS, the Mayo and the EFA elbow-scoring scales can all be used as an evaluative instrument to assess the efficacy of surgical treatment of the rheumatoid elbow joint. However, using the EFA scale will require smaller sample sizes to achieve a fixed level of statistical power than the other scales under study

Background

This article reviews four commonly used approaches to assess patient responsiveness to a treatment or therapy [Return To Normal (RTN), Minimal Important Difference (MID), Minimal Clinically Important Difference (MCID), OMERACT-OARSI (OO)], and demonstrates how each of the methods can be formulated in a multi-level modelling (MLM) framework.

Forty-nine patients with a repair of their rotator cuff were evaluated at baseline and at six-months after surgery using four self-reports scales (DASH, Western Ontario Rotator Cuff (WORC,) SF-36 and Washington Simple Shoulder (SST) scales. Standardized response means were used to determine responsiveness. The DASH was most responsive (SRM=1.27), the WORC (SRM=1.0) and SST (0.91) were intermediary and the least response was the SF-36 (0.73). These results suggest that the DASH may be preferable to either a disease specific scale or a shoulder scale for detecting clinical progress following cuff repair.

A number of self-report scales exist for shoulder problems, including regional, joint-specific and disease specific scales. Determining the most responsive scale is essential for outcome evaluation and clinical trials.

Forty-nine patients with a repair of their rotator cuff were evaluated at baseline and at six-months after surgery using four self-reports scales (DASH, Western Ontario Rotator Cuff (WORC,) SF-36 and Washington Simple Shoulder (SST) scales. An independent research assistant administered scales. Standardized response means were used to determine responsiveness.

The DASH was most responsive (SRM=1.27), the WORC (SRM=1.0) and SST (0.91) were intermediary and the least response was the SF-36 (0.73). The subscale of the WORC that showed the most change was lifestyle. Physical subscales of the SF-36 showed improvement; whereas, minimal impact on mental health was observed.

The DASH can be used for a variety of upper extremity conditions, whereas the WORC was designed specifically for rotator cuff disease. Unless a disease specific scale is more responsive, there is little reason to adopt a scale than can only be used for one condition. This data supports the ability of the DASH to indicate upper extremity function and the important role of the rotator cuff in function.

The implications of these findings are that the DASH may be preferable to either a disease specific scale for rotator cuff disease or a shoulder scale for detecting clinical progress.

Summary: The SF-36, FFI, AOS and the AOFAS AHS were recorded pre and post-operatively in patients with end-stage ankle arthritis. Comparison of responsiveness shows the AOFAS score to be completely unresponsive.

Introduction: Outcome studies should include both general health and disease specific measures. The Short Form 36 (SF36) is validated and widely used in musculoskeletal disease. A number of disease specific scores are available for the foot and ankle but, at present there is no widely agreed and validated score used specifically in end-stage ankle arthritis (EAA).

Methods: 555 sets of pre and post-operative data on 239 EAA patients undergoing definitive treatment have been collected. The SF36 and three widely used Foot and Ankle scores (Foot Function Index (FFI), AOFAS Ankle Hindfoot Score (AHS) and Ankle Osteoarthritis Scale (AOS)) were recorded. We assessed the responsiveness (Standardized Response Mean (SRM) and Effect Size (ES)) and correlation (Spearman Rank Correlation) of each of the above scores.

Results: The SF36, FFI and AOS responded to change and correlated in sub-scale and total scores. The AHS did not respond to change in pain or total scores and did not correlate with any other score.

Using the three responsive scores there was a significant improvement in outcome with operative intervention (p< 0.0001) with each score. Using the SRM and the ES, the AOS showed the highest level of responsiveness. It also showed an increased response rate suggesting that patients find it more useable.

Conclusion: In future studies we would recommend the use of the SF36 and the AOS for assessment of patients with EAA. We would also discourage use of the AOFAS Ankle Hindfoot Score which we have demonstrated to be unresponsive to change.

Introduction: The Lysholm knee score and the Tegner activity scale are frequently used to assess outcome following treatment of meniscus pathology. The purpose of this study was to determine the psychometric properties of the Lysholm knee score and Tegner activity level for meniscus injuries of the knee.

Methods: Test-retest reliability, content validity, criterion validity, construct validity, and responsiveness to change were determined for the Lysholm score and the Tegner activity scale within 3 subsets of patients. Group A contained patients with only meniscus pathology at surgery (no ligament pathology or chondral surface pathology) (n=191). Group B consisted of patients at least 2 years from surgery for meniscus pathology, who completed a follow-up form and then completed a retest with 4 weeks of the primary questionnaire (n=122). Group C consisted of patients with meniscus pathology with other intraarticular pathology (n=477).

Results: There were acceptable (intraclass correlation coefficient > 0.70) test-retest reliability for the overall Lysholm score and the Tegner activity scale. (Group B). There were acceptable floor and ceiling effects for the Tegner scale (floor: 8.1%; ceiling: 2.5%) and the overall Lysholm score (floor: 0%; ceiling: 0.4%) (Group A and C). There were unacceptable (> 30%) ceiling effects for the Lysholm domains of limp, instability, support, and locking. There was acceptable criterion validity, with significant (P< 0.05) correlations between the Tegner activity scale and the physical score of the SF-12 and between the overall Lysholm score and the physical score of the SF-12(Group C). There was acceptable construct validity for the Tegner activity scale and Lysholm score, with all hypotheses demonstrating significance (P< 0.05) (Group A). There was acceptable responsiveness to change for the Tegner activity scale (Group A effect size=0.61; standardized response mean=0.60; Group C effect size=0.84; standardized response mean=0.70) and the Lysholm score(Group A effect size=1.2; standardized response mean=0.97; Group C effect size =1.2; standardized response mean =1.13).

Discussion: The use of outcome instruments whose psychometric properties have been vigorously established is essential. The Lysholm knee score demonstrated overall acceptable psychometric performance for outcomes assessment of meniscus injuries of the knee, although some domains demonstrated suboptimal performance. The Tegner activity scale demonstrated overall acceptable psychometric performance for outcomes assessment of meniscus injuries of the knee, however, it demonstrated only moderate effect size. Psychometric testing of other condition-specific knee instruments in patients with meniscus pathologies of the knee would be helpful to allow for comparison of properties.

Purpose: The purpose of this study was to determine psychometric properties of the Lysholm score and Tegner activity scale as patient-administered outcomes scores for anterior cruciate ligament injuries of the knee. We hypothesized that these two outcomes measures remain valid by today’s standards twenty-five years after they were originally introduced as physician-administered outcomes instruments.

Methods: One thousand seven hundred eighty-three (1783) patients were included in this study. There were 749 females and 1034 males. Average age was 37 years (range, 18 to 77). Isolated ACL tears were documented in 593 patients, and 1190 patients had concurrent injuries including meniscus pathology and/or cartilage damage. Patients with multiple ligamentous injuries were excluded. All patients in this study were diagnosed with an ACL tear at arthroscopy. For responsiveness, scores were measured preoperatively and at a minimum of two years postoperatively. For test-retest, scores were measured at a minimum of two years postoperatively and again within four weeks of the original postoperative questionnaire. For criterion validity, patients completed the short form (SF-12^®) of the health related quality-of-life scale and the IKDC score in addition to Lysholm and Tegner instruments. For all other analyses, preoperative Lysholm score or Tegner activity levels were used.

Results: There was acceptable test-retest reliability for overall Lysholm score (ICC=0.94 [95% confidence interval=0.88 to 0.96]) and Tegner (ICC=0.82 [95% confidence interval=0.66 to 0.89]). The minimum detectable change for Lysholm was 8.9 and for Tegner was 1.4. The Lysholm score demonstrated acceptable internal consistency (Cronbach’s alpha=0.72). The Lysholm score correlated with IKDC (r=0.78) and the physical function domain of SF-12^® (r=0.43). The Tegner scale correlated with physical function domain of SF-12^® (r=0.2) and IKDC (r=0.22). Both scores had acceptable floor and ceiling effects, and all hypotheses were significant. The Lysholm score and Tegner scale both had a large overall effect size. There were no differences between isolated and combined ACL injuries.

Conclusion: After 25 years of changes in treatment of ACL injuries and postoperative rehabilitation protocols, the Lysholm knee score and Tegner activity scale continue to demonstrate acceptable psychometric parameters. The Lysholm score and Tegner scale both had acceptable test-retest reliability, construct validity, criterion validity, content validity, and responsiveness when patient-administered similar to the physician-administered results when they were originally validated. Our hypothesis was affirmed.

Introduction: The SRS-22 questionnaire is a disease specific instrument developed to assess the effect of idiopathic scoliosis on the patient from their vantage point. This study is being conducted to determine the responsiveness of the SRS-22 questionnaire to patient change associated with surgery.

Material and methods: This is a prospective study of surgically treated patients. The SRS-22 outcomes questionnaire consists of five domains: Pain; self image; function; mental health and satisfaction with management/surgery. There are five questions in each of the first four domains and two in the last. The scoring scale is 5 best and 1 lowest. Patients were tested pre-operatively and then at 3, 6 and 12 months post-operatively. Statistical analysis was done using the paired t-test. Comparisons were only performed on individuals with domain scores at the follow-up interval being tested. There were 33 patients (6 male and 27 female) average age 15.7 years with average Cobb size of 64°.

Results: Self image was significantly improved at three months and remained improved; Pre-operative 3.3; 3 months 4.2 p< 0.0001); 6 months 4.0 (p=0.079); and 12 months 4.2 (p> 0.0425). Function was significantly decreased at three months but returned to baseline at 6 and 12 months: Pre-operative 3.9; 3 months post-operative 3.3 (p=0.0024); 6 months 3.8 (ns) and 12 months 4.0 (ns). Surprisingly pain did not show significant change being 3.9 pre-operatively; 3.6 at 3 months; 3.5 at 6 months, and 4.1 at 12 months.

Conclusion: Based on these very preliminary data the SRS-22 questionnaire has been found to be responsive to self image and function changes in the post-surgical period. The function change was anticipated. The self image improvement occurred earlier than had been anticipated. The questionnaire was not responsive to pain change and did not reflect the substantial pain the patients had gone through at the time of the surgery. As anticipated the mental health domain was unchanged overall.

Aims. The aim of this study was to report the meaningful values of the EuroQol five-dimension three-level questionnaire (EQ-5D-3L) and EuroQol visual analogue scale (EQ-VAS) in patients undergoing primary knee arthroplasty (KA). Methods. This is a retrospective study of patients undergoing primary KA for osteoarthritis in a university teaching hospital (Royal Infirmary of Edinburgh) (1 January 2013 to 31 December 2019). Pre- and postoperative (one-year) data were prospectively collected for 3,181 patients (median age 69.9 years (interquartile range (IQR) 64.2 to 76.1); females, n = 1,745 (54.9%); median BMI 30.1 kg/m. 2. (IQR 26.6 to 34.2)). The reliability of the EQ-5D-3L was measured using Cronbach’s alpha. Responsiveness was determined by calculating the anchor-based minimal clinically important difference (MCID), the minimal important change (MIC) (cohort and individual), the patient-acceptable symptom state (PASS) predictive of satisfaction, and the minimal detectable change at 90% confidence intervals (MDC-90). Results. The EQ-5D-3L demonstrated good internal consistency with an overall Cronbach alpha of 0.75 (preoperative) and 0.88 (postoperative), respectively. The MCID for the Index score was 0.085 (95% confidence interval (CI) 0.042 to 0.127) and EQ-VAS was 6.41 (95% CI 3.497 to 9.323). The MIC. COHORT. was 0.289 for the EQ-5D and 5.27 for the EQ-VAS. However, the MIC. INDIVIDUAL. for both the EQ-5D-3L Index (0.105) and EQ-VAS (-1) demonstrated poor-to-acceptable reliability. The MDC-90 was 0.023 for the EQ-5D-3L Index and 1.0 for the EQ-VAS. The PASS for the postoperative EQ-5D-3L Index and EQ-VAS scores predictive of patient satisfaction were 0.708 and 77.0, respectively. Conclusion. The meaningful values of the EQ-5D-3L Index and EQ-VAS scores can be used to measure clinically relevant changes in health-related quality of life in patients undergoing primary KA. Cite this article: Bone Joint Res 2022;11(9):619–628

Aims. Responsiveness to clinically important change is a key feature of any outcome measure. Throughout Europe, health-related quality of life following total knee arthroplasty (TKA) is routinely measured with EuroQol five-dimension (EQ-5D) questionnaires. The Patient-Reported Outcomes Measurement Information System 10-Question Short-Form (PROMIS-10 Global Health) score is a new general heath outcome tool which is thought to offer greater responsiveness. Our aim was to compare these two tools. Patients and Methods. We accessed data from a prospective multicentre cohort study in the United Kingdom, which evaluated outcomes following TKA. The median age of the 721 patients was 69.0 years (interquartile range, 63.3 to 74.6). There was an even division of sex, and approximately half were educated to secondary school level. The preoperative EQ-5D, PROMIS-10, and Oxford Knee Scores (OKS) were available and at three, six, and 12 months postoperatively. Internal responsiveness was assessed by standardized response mean (SRM) and effect size (Cohen’s d). External responsiveness was assessed by correlating change scores of the EQ-5D and PROMIS-10, with the minimal clinically important difference (MCID) of the OKS. Receiver operating characteristic (ROC) curves were used to assess the ability of change scores to discriminate between improved and non-improved patients. Results. All measures showed significant changes between the preoperative score and the various postoperative times (p < 0.001). Most improvement occurred during the first three months, with small but significant changes between three and six months, and no further change between six and 12 months postoperatively. SRM scores for EQ-5D, PROMIS-10, and OKS were large (> 0.8). ROC curves showed that both EQ-5D and PROMIS-10 were able to discriminate between patients who achieved the OKS MCID and those who did not (area under the curve (AUC) of 0.7 to 0.82). Conclusion. The PROMIS-10 physical health tool showed greater responsiveness to change than the EQ-5D, most probably due to the additional questions on physical health parameters that are more susceptible to modification following TKA. The EQ-5D was, however, shown to be sensitive to clinically meaningful change following TKA, and provides the additional ability to calculate health economic utility scores. It is likely, therefore, that EQ-5D will continue to be the global health metric of choice in the United Kingdom. Cite this article: Bone Joint J 2019;101-B:832–837

This study investigates the use of the Metabolic Equivalent of Task (MET) score in a hip arthroplasty population and its ability to capture additional benefit beyond the maximum Oxford Hip Score (OHS). OHS, EuroQol-5D index (EQ-5D), and the MET were prospectively recorded in 221 primary hip arthroplasty procedures pre-operatively and at 1-year. The distribution was examined reporting the presence of ceiling & floor effects. Validity was assessed correlating the MET with the other scores using Spearman's rank and determining responsiveness using the standardised response mean (SRM). A subgroup of 93 patients scoring 48/48 on the OHS were analysed by age group, sex, BMI and pre-operative MET using the other two metrics to determine if differences could be established despite all scoring identically on the OHS. 117 total hip and 104 hip resurfacing arthroplasty operations were included. Mean age was 59.4 ± 11.3. Post-operatively the OHS and EQ-5D demonstrate significant negatively skewed distributions with ceiling effects of 41% and 53%, respectively. The MET was normally distributed post-operatively with no ceiling effect. Weak-moderate but statistically significant correlations were found between the MET and the other two metrics both pre & post-operatively. Responsiveness was excellent, SRM for OHS: 2.01, EQ-5D: 1.06 and MET: 1.17. In the 48/48 scoring subgroup, no differences were found comparing groups with the EQ-5D, however significantly higher MET scores were demonstrated for patients aged <60 (12.7 vs 10.6, p=0.008), male patients (12.5 vs 10.8, p=0.024) and those with pre-operative MET scores >6 (12.6 vs 11.0, p=0.040). The MET is normally distributed in patients following hip arthroplasty, recording levels of activity which are undetectable using the OHS. As a simple, valid activity metric, it should be considered in addition to conventional PROMs in order to capture the entire benefit experienced following hip arthroplasty

Introduction and Objective. An important subset of patients is dissatisfied after total joint arthroplasty (TJA) due to residual functional impairment. This study investigated the assessment of objectively measured step-up performance following TJA, to identify patients with poor functional improvement after surgery, and to predict residual functional impairment during early postoperative rehabilitation. Secondary, longitudinal changes of block step-up (BS) transfers were compared with functional changes of subjective patient reported outcome measures (PROMs) following TJA. Materials and Methods. Patients with end stage hip or knee osteoarthritis (n = 76, m/f = 44/32; mean age = 64.4 standard deviation 9.4 years) were measured preoperatively and 3 and 12 months postoperatively. PROMs were assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function subscore. BS transfers were assessed by wearable-derived measures of time. In our cohort, subgroups were formed based on either 1) WOMAC function score or 2) BS performance, isolating the worst performing quartile (impaired) of each measure from the better performing others (non-impaired). Subgroup comparisons were performed with the Man-Whitney-U test and Wilcoxon Signed rank test resp. Responsiveness was calculated by the effect size, correlations with Pearson's correlation coefficient. A regression analysis was conducted to investigate predictors of poor functional outcome. Results. WOMAC function scores were strongly correlated to WOMAC pain scores (Pearson's r=0.67–0.84) and moderately correlated to BS performance (Pearson's r = 0.31–0.54). Prior to surgery, no significant differences for WOMAC function scores and BS performance were found between the impaired and non-impaired subgroups. One year after TJA, our cohort performed significantly better at WOMAC and BS with largest effect size for the non-impaired subgroups (0.62 and 0.43 resp.) At 12 months postop, 56% of patients allocated to the impaired subgroup defined by WOMAC, represented the impaired subgroup defined by BS. Allocation to the impaired subgroup at 3 months postop, raised the odds for belonging to the impaired subgroup at 12 months for WOMAC with an odds ratio=19.14 (67%) and for BS with an odds ratio=4.41 (42%). Conclusions. Assessment of BS performance following TJA reveals residual functional impairment that is not captured by pain-dominated PROMs. Its additional use may help to early identify those patients at risk for a poor outcome

Aims

The metabolic equivalent of task (MET) score examines patient performance in relation to energy expenditure before and after knee arthroplasty. This study assesses its use in a knee arthroplasty population in comparison with the widely used Oxford Knee Score (OKS) and EuroQol five-dimension index (EQ-5D), which are reported to be limited by ceiling effects.

Clinical management of patellofemoral (PF) instability is a challenge, particularly considering the wide range of contributing variables that must be taken into consideration when determining optimal treatment. An important outcome measure to consider in this patient population is disease-specific quality of life (QOL). The purpose of this study was to factor analyse and reduce the total number of items in the Banff Patellar Instability Instrument (BPII). Subsequent to the factor analysis, the new, item-reduced BPII 2.0 was tested for validity, reliability and responsiveness. Disease-specific QOL was measured in patients with a confirmed diagnosis of PF instability (n = 223) at the initial consultation with the original BPII. Data from these BPII scores was used to employ a principal component analysis (PCA) to factor analyse and reduce the total number of items in the original BPII, to create the new BPII 2.0. The BPII 2.0 underwent content validation (Cronbach's Alpha, patient interviews and reading-level); construct validation (ANOVA comparing the initial consultation, 6, 12 and 24 month post-operative, Eta squared); convergent validation (Pearson r correlation to the original BPII); responsiveness testing (Eta squared, anchor-based distribution testing); and reliability testing (intra-class correlation coefficient (ICC) 2,k). The original BPII was successfully reduced from 32 to 23 items. The new BPII 2.0 demonstrated excellent Cronbach's Alpha values: initial consult = 0.91; 6-months = 0.96; 12-months = 0.97; and 24-months post-operative = 0.76. Grade-level reading assessment for all items in the BPII 2.0 was below grade twelve. The ANOVA determined the BPII 2.0 was able to discriminate between the initial consultation, 6, 12 and 24 months post-operative assessments, with significant differences between each time-point (p < 0.05). Eta squared was 0.40, demonstrating a medium to large effect size. Convergent validity was established with the BPII 2.0 significantly correlated to the original BPII (initial consult = 0.82, 6-month = 0.90, 12-month = 0.90, and 24-month = 0.94). Anchor-based responsiveness was established with a significant correlation between the 7-point scale of patient-perceived improvement and 24-month post-operative BPII 2.0 scores. Strong reliability was established with an ICC (2,k) = .97. The BPII has undergone a critical step in its psychometric and clinimetric evolution: structural validation. With the work completed in this study, the BPII and BPII 2.0 have completed assessment of seven of the nine Consensus-based Standards for the selection of health Measurement INstruments (COSMIN) properties including: 1) Internal consistency; 2) Reliability; 3) Standard error of measurement; 4) Content validation; 5) Structural validity; 6) Criterion validity; and, 7) Responsiveness testing. Completion of these assessments and the introduction of a structurally valid and shorter questionnaire, the BPII 2.0, provides a definitive level of credibility to this disease-specific outcome measure

Objectives. To study the measurement properties of a joint specific patient reported outcome measure, a measure of capability and a general health-related quality of life (HRQOL) tool in a large cohort of patients with a hip fracture. Methods. Responsiveness and associations between the Oxford Hip Score (a hip specific measure: OHS), ICEpop CAPability (a measure of capability in older people: ICECAP-O) and EuroQol EQ-5D (general health-related quality of life measure: EQ-5D) were assessed using data available from two large prospective studies. The three outcome measures were assessed concurrently at a number of fixed follow-up time-points in a consecutive sequence of patients, allowing direct assessment of change from baseline, inter-measure associations and validity using a range of statistical methods. Results. ICECAP-O was not responsive to change. EQ-5D was responsive to change from baseline, with an estimated standardised effect size for the two datasets of 0.676 and 0.644 at six weeks and four weeks respectively; this was almost as responsive to change as OHS (1.14 at four weeks). EQ-5D correlated strongly with OHS; Pearson correlation coefficients were 0.74, 0.77 and 0.70 at baseline, four weeks and four months. EQ-5D is a moderately good predictor of death at 12 months following hip fracture. Furthermore, EQ-5D reported by proxies (relatives and carers) behaves similarly to self-reported scores. Conclusions. Our findings suggest that a general HRQOL tool such as EQ-5D could be used to measure outcome for patients recovering from hip fracture, including those with cognitive impairment. Cite this article: Bone Joint Res 2014;3:69–75

Aims

The purpose of this study was to assess the reliability and responsiveness to hip surgery of a four-point modified Care and Comfort Hypertonicity Questionnaire (mCCHQ) scoring tool in children with cerebral palsy (CP) in Gross Motor Function Classification System (GMFCS) levels IV and V.

Aims

To identify the responsiveness, minimal clinically important difference (MCID), minimal clinical important change (MIC), and patient-acceptable symptom state (PASS) thresholds in the 36-item Short Form Health Survey questionnaire (SF-36) (v2) for each of the eight dimensions and the total score following total knee arthroplasty (TKA).