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.
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’.
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. Data from the Arthroplasty Pain Experience (APEX) cohort study was used. Patients undergoing total hip and knee replacement completed the Intermittent and Constant Osteoarthritis Pain (ICOAP) questionnaire prior to surgery and then at 3, 6 and 12 months after surgery. We compare baseline scores, change scores, and proportion of individuals defined as “responders” using traditional and multi-level model (MLM) approaches to patient responsiveness.Background
Methods
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.
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.
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.
Aims.
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.
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.
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. A total of 116 patients with OKS, EQ-5D, and MET scores before, and at least six months following, unilateral primary knee arthroplasty were identified from a database. Procedures were performed by a single surgeon between 2014 and 2019 consecutively. Scores were analyzed for normality, skewness, kurtosis, and the presence of ceiling/floor effects. Concurrent validity between the MET score, OKS, and EQ-5D was assessed using Spearman’s rank.Aims
Methods
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)
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.
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. This was a population-based cohort study in children with CP from a national surveillance programme. Reliability was assessed from 20 caregivers who completed the mCCHQ questionnaire on two occasions three weeks apart. Test-retest reliability of the mCCHQ was calculated, and responsiveness before and after surgery for a displaced hip was evaluated in a cohort of children.Aims
Methods
A core outcome set for adult, open lower limb fracture has been established consisting of ‘Walking, gait and mobility’, ‘Being able to return to life roles’, ‘Pain or discomfort’, and ‘Quality of life’. This study aims to identify which outcome measurement instruments (OMIs) should be recommended to measure each core outcome. A systematic review and quality assessment were conducted to identify existing instruments with evidence of good measurement properties in the open lower limb fracture population for each core outcome. Additionally, shortlisting criteria were developed to identify suitable instruments not validated in the target population. Candidate instruments were presented, discussed, and voted on at a consensus meeting of key stakeholders.Aims
Methods
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). There were 3,321 patients undergoing primary TKA with preoperative and one-year postoperative SF-36 scores. At one-year patients were asked how satisfied they were and “How much did the knee arthroplasty surgery improve the quality of your life?”, which was graded as: great, moderate, little (n = 277), none (n = 98), or worse.Aims
Methods
Healthcare interventions are under increasing scrutiny regarding cost-effectiveness and outcome measures have revolutionised clinical research. To identify all available outcome questionnaires designed for lowback, lumbar spine pathologies and to perform qualitative analysis of these questionnaires for their clinimetric properties. A comprehensive e-search on PUBMED & EMBASE for all available outcome measures and published review articles for lowback and lumbar spine pathologies was undertaken over a two month period (Nov-Dec 2009). Twenty-eight questionnaires were identified in total. These outcomes questionnaires were evaluated for clinimetric properties viz:-. Validity (content, construct & criterion validity). Reliability (internal consistency & reproducibility).
This study investigates the use of the metabolic equivalent of task (MET) score in a young hip arthroplasty population, and its ability to capture additional benefit beyond the ceiling effect of conventional patient-reported outcome measures. From our electronic database of 751 hip arthroplasty procedures, 221 patients were included. Patients were excluded if they had revision surgery, an alternative hip procedure, or incomplete data either preoperatively or at one-year follow-up. Included patients had a mean age of 59.4 years (SD 11.3) and 54.3% were male, incorporating 117 primary total hip and 104 hip resurfacing arthroplasty operations. Oxford Hip Score (OHS), EuroQol five-dimension questionnaire (EQ-5D), and the MET were recorded preoperatively and at one-year follow-up. The distribution was examined reporting the presence of ceiling and floor effects. Validity was assessed correlating the MET with the other scores using Spearman’s rank correlation coefficient and determining responsiveness. A subgroup of 93 patients scoring 48/48 on the OHS were analyzed by age, sex, BMI, and preoperative MET using the other metrics to determine if differences could be established despite scoring identically on the OHS.Aims
Methods