Outcomes in Ankle Replacement Study (OARS).

Aims: The aim of this study was to capture 12-month outcomes from a representative multicentre cohort of patients undergoing total ankle arthroplasty (TAA), describe the pattern of patient-reported outcome measures (PROMs) at 12 months, and identify predictors of these outcome measures. Methods: Patients listed for a primary TAA at 19 NHS hospitals between February 2016 and October 2017 were eligible. PROMs data were collected preoperatively and at six and 12 months including: Manchester-Oxford Foot and Ankle Questionnaire (MOXFQ (foot and ankle)) and the EuroQol five-dimension five-level questionnaire (EQ-5D-5L). Radiological pre- and postoperative data included Kellgren-Lawrence score and implant position measurement. This was supplemented by data from the National Joint Registry through record linkage to determine: American Society of Anesthesiologists (ASA) grade at index procedure; indication for surgery, index ankle previous fracture; tibial hind foot alignment; additional surgery at the time of TAA; and implant type. Multivariate regression models assessed outcomes, and the relationship between MOXFQ and EQ-5D-5L outcomes, with patient characteristics. Results: Data from 238 patients were analyzed. There were significant improvements in MOXFQ and EQ-5D-5L among people who underwent TAA at six- and 12-month assessments compared with preoperative scores (p < 0.001). Most improvement occurred between preoperative and six months, with little further improvement at 12 months. A greater improvement in MOXFQ outcome postoperatively was associated with older age and more advanced radiological signs of ankle osteoarthritis at baseline. Conclusion: TAA significantly benefits patients with end-stage ankle disease. The lack of substantial further overall change between six and 12 months suggests that capturing PROMs at six months is sufficient to assess the success of the procedure. Older patients and those with advanced radiological disease had the greater gains. These outcome predictors can be used to counsel younger patients and those with earlier ankle disease on the expectations of TAA.

Patient perceptions of health-related quality of life in giant cell arteritis: international development of a disease-specific patient-reported outcome measure.

OBJECTIVES: GCA is a large vessel vasculitis (LVV) presenting with headache, jaw claudication, musculoskeletal and visual involvement. Current treatment is glucocorticoids and anti-IL-6 tocilizumab in refractory disease. The objective of this study was to explore the impact of GCA and its treatment on people's health-related quality of life (HRQoL), to inform the development of a disease-specific patient-reported outcome measure (PROM) for use in clinical trials and practice. METHODS: Participants from the UK and Australia, with biopsy- or imaging-confirmed GCA, were interviewed to identify salient aspects of HRQoL in relation to GCA and its treatment. Purposive sampling included a range of demographic and disease features (cranial, LVV-GCA and visual involvement). Inductive analysis identified individual themes of importance, then domains. Candidate questionnaire items were developed from the individual themes, refined by piloting, cognitive interviews and a linguistic translatability assessment. RESULTS: Thirty-six interviews were conducted to saturation with participants with GCA from the UK (25) and Australia (11). Mean age was 74 years, 23 (63.9%) were female, 13 (36.1%) had visual loss and 5 (13.9%) had LVV-GCA. Thirty-nine individual themes within five domains were identified: physical symptoms; activity of daily living and function; participation; psychological impact; and impact on sense of self and perception of health. Sixty-nine candidate items were developed from individual themes; piloting and refinement resulted in a 40-item draft questionnaire. CONCLUSION: This international qualitative study underpins the development of candidate items for a disease-specific PROM for GCA. The draft questionnaire is now ready for psychometric testing.

The Arthroplasty Candidacy Help Engine tool to select candidates for hip and knee replacement surgery: development and economic modelling.

BACKGROUND: There is no good evidence to support the use of patient-reported outcome measures (PROMs) in setting preoperative thresholds for referral for hip and knee replacement surgery. Despite this, the practice is widespread in the NHS. OBJECTIVES/RESEARCH QUESTIONS: Can clinical outcome tools be used to set thresholds for hip or knee replacement? What is the relationship between the choice of threshold and the cost-effectiveness of surgery? METHODS: A systematic review identified PROMs used to assess patients undergoing hip/knee replacement. Their measurement properties were compared and supplemented by analysis of existing data sets. For each candidate score, we calculated the absolute threshold (a preoperative level above which there is no potential for improvement) and relative thresholds (preoperative levels above which individuals are less likely to improve than others). Owing to their measurement properties and the availability of data from their current widespread use in the NHS, the Oxford Knee Score (OKS) and Oxford Hip Score (OHS) were selected as the most appropriate scores to use in developing the Arthroplasty Candidacy Help Engine (ACHE) tool. The change in score and the probability of an improvement were then calculated and modelled using preoperative and postoperative OKS/OHSs and PROM scores, thereby creating the ACHE tool. Markov models were used to assess the cost-effectiveness of total hip/knee arthroplasty in the NHS for different preoperative values of OKS/OHSs over a 10-year period. The threshold values were used to model how the ACHE tool may change the number of referrals in a single UK musculoskeletal hub. A user group was established that included patients, members of the public and health-care representatives, to provide stakeholder feedback throughout the research process. RESULTS: From a shortlist of four scores, the OHS and OKS were selected for the ACHE tool based on their measurement properties, calculated preoperative thresholds and cost-effectiveness data. The absolute threshold was 40 for the OHS and 41 for the OKS using the preferred improvement criterion. A range of relative thresholds were calculated based on the relationship between a patient's preoperative score and their probability of improving after surgery. For example, a preoperative OHS of 35 or an OKS of 30 translates to a 75% probability of achieving a good outcome from surgical intervention. The economic evaluation demonstrated that hip and knee arthroplasty cost of < £20,000 per quality-adjusted life-year for patients with any preoperative score below the absolute thresholds (40 for the OHS and 41 for the OKS). Arthroplasty was most cost-effective for patients with lower preoperative scores. LIMITATIONS: The ACHE tool supports but does not replace the shared decision-making process required before an individual decides whether or not to undergo surgery. CONCLUSION: The OHS and OKS can be used in the ACHE tool to assess an individual patient's suitability for hip/knee replacement surgery. The system enables evidence-based and informed threshold setting in accordance with local resources and policies. At a population level, both hip and knee arthroplasty are highly cost-effective right up to the absolute threshold for intervention. Our stakeholder user group felt that the ACHE tool was a useful evidence-based clinical tool to aid referrals and that it should be trialled in NHS clinical practice to establish its feasibility. FUTURE WORK: Future work could include (1) a real-world study of the ACHE tool to determine its acceptability to patients and general practitioners and (2) a study of the role of the ACHE tool in supporting referral decisions. FUNDING: The National Institute for Health Research Health Technology Assessment programme.

Patients with severe hip and knee arthritis may require joint replacement. General practitioners make the decision to refer patients to hospital based on an assessment of their symptoms. Pain and function can be measured using patient questionnaires and the questionnaire scores can indicate whether or not the severity of disease warrants referral (i.e. whether or not the patient is a candidate for joint replacement based on their 'capacity to benefit'). However, we do not know whether or not basing treatment decisions on such scores is correct, nor do we know what exact pain score thresholds should be used for referral. After a thorough search, we found that the Oxford Hip and Knee Scores were the best instruments. A high score (i.e. a maximum score of 48) indicates less pain and better function. The threshold values for referral for surgery were scores of 40 for hips and 41 for knees. The process of evaluating scoring systems, the choice of scoring systems and the threshold values were discussed and agreed by a panel of patients and by doctors throughout the study. Most patients with severe joint pain benefit from joint replacement, and these operations are cost-effective. However, above a certain level (a score of 40 for hips and 41 for knees), patients are not thought to typically benefit from surgery. Below these values, lower presurgery scores indicate a steadily increasing likelihood of benefit in terms of reduced pain and better function. This information provides the basis for a tool to help doctors decide who to refer for joint replacement: the Arthroplasty Candidacy Help Engine (ACHE). Use of the ACHE tool prevents patients who are unlikely to benefit from joint replacement being referred unnecessarily and allows the NHS to concentrate resources on those who will benefit most from arthroplasty treatment.

Validation of the ANCA-associated vasculitis patient-reported outcomes (AAV-PRO) questionnaire.

OBJECTIVES: To finalise and validate a disease-specific patient-reported outcome (PRO) measure: the ANCA-associated vasculitis patient-reported outcome (AAV-PRO) questionnaire. Using a 35-item candidate questionnaire developed following 50 qualitative interviews in the UK, USA and Canada, a longitudinal survey was conducted to determine the final scale structure and validate the AAV-PRO. METHODS: Participants were recruited via Vasculitis UK and the Vasculitis Patient-Powered Research Network. The 35-item candidate questionnaire was completed at baseline and 3 months; UK participants completed the EuroQol-5D-5L (EQ-5D-5L), while US participants completed a test-retest exercise, 3-5 days after baseline. Scale structure was defined using exploratory factor analysis (EFA) and Rasch analysis. Convergent and known groups validity, test-retest reliability and longitudinal construct validity were assessed. RESULTS: There were 626 participants with AAV; >25% reporting 'active disease'. EFA and Rasch analysis supported a 29-item profile measure comprising six domains: 'organ-specific symptoms', 'systemic symptoms', 'treatment side effects', 'social and emotional impact', 'concerns about the future' and 'physical function'. Mean domain scores were higher for participants with 'active disease' versus 'remission' (p<0.001). Construct validity was demonstrated by correlations between domain scores and the EQ-5D-5L (range r=-0.55 to 0.78), all p<0.0001. In participants reporting 'no change' (n=97) during the test-retest, intraclass correlation coefficient values were high (range 0.89-0.96) for each domain. CONCLUSIONS: The AAV-PRO, a new disease-specific PRO measure for AAV, has good face and construct validity, is reliable, feasible and discriminates among disease states.

Health-related quality of life in ANCA-associated vasculitis and item generation for a disease-specific patient-reported outcome measure.

OBJECTIVE: The antineutrophil cytoplasmic antibody (ANCA)-associated vasculitides (AAVs) are multisystem diseases of the small blood vessels. Patients experience irreversible damage and psychological effects from AAV and its treatment. An international collaboration was created to investigate the impact of AAV on health-related quality of life (HRQoL), and develop a disease-specific patient-reported outcome measure to assess outcomes of importance to patients. METHODS: Patients with AAV from the UK, USA, and Canada were interviewed to identify salient aspects of HRQoL affected by AAV. The study was overseen by a steering committee including four patient research partners. Purposive sampling of interviewees ensured representation of a range of disease manifestations and demographics. Inductive analysis was used to identify themes of importance to patients; these were further confirmed by a free-listing exercise in the US. Individual themes were recast into candidate items, which were scrutinized by patients, piloted through cognitive interviews and received a linguistic and translatability evaluation. RESULTS: Fifty interviews, conducted to saturation, with patients from the UK, USA, and Canada, identified 55 individual themes of interest within seven broad domains: general health perceptions, impact on function, psychological perceptions, social perceptions, social contact, social role, and symptoms. Individual themes were constructed into >100 candidate questionnaire items, which were then reduced and refined to 35 candidate items. CONCLUSION: This is the largest international qualitative analysis of HRQoL in AAV to date, and the results have underpinned the development of 35 candidate items for a disease-specific, patient-reported outcome questionnaire.

Patient perceptions of glucocorticoids in anti-neutrophil cytoplasmic antibody-associated vasculitis.

Granulomatosis with polyangiitis (GPA), microscopic polyangiitis (MPA), and eosinophilic granulomatosis with polyangiitis (EGPA) are multisystem diseases of small blood vessels, collectively known as the anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitides (AAV). This study explores the patient's perspective on the use of glucocorticoids, which are still a mainstay of treatment in AAV. Patients with AAV from the UK, USA, and Canada were interviewed, using purposive sampling to include a range of disease manifestations and demographics. The project steering committee, including patient partners, designed the interview prompts and cues about AAV, its treatment, and impact on health-related quality of life. Interviews were transcribed and analysed to establish themes grounded in the data. A treatment-related code was used to focus analysis of salient themes related to glucocorticoid therapy. Fifty interviews were conducted. Individual themes related to therapy with glucocorticoids emerged from the data and were analysed. Three overarching themes emerged: (1) Glucocorticoids are effective at the time of diagnosis and during relapse, and withdrawal can potentiate a flare, (2) glucocorticoids are associated with salient emotional, physical, and social effects (depression, anxiety, irritation, weight gain and change in appearance, diabetes mellitus, effect on family and work); and (3) patient perceptions of balancing the risks and benefits of glucocorticoids. Patients identified the positive aspects of treatment with glucocorticoids; they are fast-acting and effective, but, they voiced concerns about adverse effects and the uncertainty of the dose-reduction process. These results may be informative in the development of novel glucocorticoid-sparing regimens.

A unified multi-level model approach to assessing patient responsiveness including; return to normal, minimally important differences and minimal clinically important improvement for patient reported outcome measures.

OBJECTIVE: This article reviews and compares four commonly used approaches to assess patient responsiveness with a treatment or therapy (return to normal (RTN), minimal important difference (MID), minimal clinically important improvement (MCII), OMERACT-OARSI [Outcome Measures in Rheumatology-Osteoarthris Reseach Society International] (OO)) and demonstrates how each of the methods can be formulated in a multilevel modelling (MLM) framework. DESIGN: Cohort study. SETTING: A cohort of patients undergoing total hip and knee replacement were recruited from a single UK National Health Service hospital. POPULATION: 400 patients from the Arthroplasty Pain Experience cohort study undergoing total hip (n=210) and knee (n=190) replacement who completed the Intermittent and Constant Osteoarthritis Pain questionnaire prior to surgery and then at 3, 6 and 12 months after surgery. PRIMARY OUTCOMES: The primary outcome was defined as a response to treatment following total hip or knee replacement. We compared baseline scores, change scores and proportion of individuals defined as 'responders' using traditional and MLM approaches with patient responsiveness. RESULTS: Using existing approaches, baseline and change scores are underestimated, and the variance of baseline and change scores overestimated in comparison with MLM approaches. MLM increases the proportion of individuals defined as responding in RTN, MID and OO criteria compared with existing approaches. Using MLM with the MCII criteria reduces the number of individuals identified as responders. CONCLUSION: MLM improves the estimation of the SD of baseline and change scores by explicitly incorporating measurement error into the model and avoiding regression to the mean when making individual predictions. Using refined definitions of responsiveness may lead to a reduction in misclassification when attempting to predict who does and does not respond to an intervention and clarifies the similarities between existing methods.

The Oxford knee score and its subscales do not exhibit a ceiling or a floor effect in knee arthroplasty patients: an analysis of the National Health Service PROMs data set.

PURPOSE: In this study, we examined whether the OKS demonstrated a floor or a ceiling effect when used to measure the outcome of knee replacement surgery in a large national cohort. METHODS: NHS PROMs database, containing pre- to 6 month post-operative OKS on 72,154 patients, mean age 69 (SD 9.4), undergoing knee replacement surgery, was examined to establish the proportion of patients achieving top or bottom OKS values pre- and post-operatively. RESULTS: Pre-operatively, none of patients achieved the maximum/'best' (48) and minimum (0) scores. Post-operatively, no patients (0 %) achieved the minimum/'worst' score, but the percentage achieving the maximum score increased to 2.7 %. Subgroup analyses demonstrated that the highest post-operative overall ceiling percentage was 3 %, in a subgroup of patients between 60 and 79 years of age and 13.7 % in a group of patients who had a pre-operative OKS above 41. Furthermore, 10.8 % of patients achieved the top post-operative OKS-PCS and 4.7 % top post-operative OKS-FCS. CONCLUSION: Based on NHS PROMs data, the OKS does not exhibit a ceiling or floor effect overall, or for both its pain and function subscales, and remains a valid measure of outcomes for patients undergoing TKA. LEVEL OF EVIDENCE: Large-scale retrospective observations study, Level II.

Systematic review of measurement properties of patient-reported outcome measures used in patients undergoing hip and knee arthroplasty.

OBJECTIVES: To identify patient-reported outcome measures (PROMs) that have been developed and/or used with patients undergoing hip or knee replacement surgery and to provide a shortlist of the most promising generic and condition-specific instruments. METHODS: A systematic review of the literature was performed to identify measures used in patients undergoing hip and knee replacement and extract and evaluate information on their methodological quality. RESULTS: Thirty-two shortlisted measures were reviewed for the quality of their measurement properties. On the basis of the review criteria, the measures with most complete evidence to date are the Oxford Hip Score (OHS) (for patients undergoing hip replacement surgery) and the Oxford Knee Score (OKS), with OKS-Activity and Participation Questionnaire (for patients undergoing knee replacement surgery). CONCLUSION: A large number of these instruments lack essential evidence of their measurement properties (eg, validity, reliability, and responsiveness) in specific populations of patients. Further research is required on almost all of the identified measures. The best-performing condition-specific PROMs were the OKS, OHS, and Western Ontario and McMaster Universities Osteoarthritis Index. The best-performing generic measure was the Short Form 12. Researchers can use the information presented in this review to inform further psychometric studies of the reviewed measures.

Patient-reported outcome measures in arthroplasty registries Report of the Patient-Reported Outcome Measures Working Group of the International Society of Arthroplasty Registries Part II. Recommendations for selection, administration, and analysis.

- The International Society of Arthroplasty Registries (ISAR) Patient-Reported Outcome Measures (PROMs) Working Group have evaluated and recommended best practices in the selection, administration, and interpretation of PROMs for hip and knee arthroplasty registries. The 2 generic PROMs in common use are the Short Form health surveys (SF-36 or SF-12) and EuroQol 5-dimension (EQ-5D). The Working Group recommends that registries should choose specific PROMs that have been appropriately developed with good measurement properties for arthroplasty patients. The Working Group recommend the use of a 1-item pain question ("During the past 4 weeks, how would you describe the pain you usually have in your [right/left] [hip/knee]?"; response: none, very mild, mild, moderate, or severe) and a single-item satisfaction outcome ("How satisfied are you with your [right/left] [hip/knee] replacement?"; response: very unsatisfied, dissatisfied, neutral, satisfied, or very satisfied). Survey logistics include patient instructions, paper- and electronic-based data collection, reminders for follow-up, centralized as opposed to hospital-based follow-up, sample size, patient- or joint-specific evaluation, collection intervals, frequency of response, missing values, and factors in establishing a PROMs registry program. The Working Group recommends including age, sex, diagnosis at joint, general health status preoperatively, and joint pain and function score in case-mix adjustment models. Interpretation and statistical analysis should consider the absolute level of pain, function, and general health status as well as improvement, missing data, approaches to analysis and case-mix adjustment, minimal clinically important difference, and minimal detectable change. The Working Group recommends data collection immediately before and 1 year after surgery, a threshold of 60% for acceptable frequency of response, documentation of non-responders, and documentation of incomplete or missing data.

Clinical effectiveness and cost-effectiveness of open and arthroscopic rotator cuff repair [the UK Rotator Cuff Surgery (UKUFF) randomised trial].

BACKGROUND: Uncertainty exists regarding the best management of patients with degenerative tears of the rotator cuff. OBJECTIVE: To evaluate the clinical effectiveness and cost-effectiveness of arthroscopic and open rotator cuff repair in patients aged ≥ 50 years with degenerative rotator cuff tendon tears. DESIGN: Two parallel-group randomised controlled trial. SETTING: Nineteen teaching and district general hospitals in the UK. PARTICIPANTS: Patients (n = 273) aged ≥ 50 years with degenerative rotator cuff tendon tears. INTERVENTIONS: Arthroscopic surgery and open rotator cuff repair, with surgeons using their usual and preferred method of arthroscopic or open repair. Follow-up was by telephone questionnaire at 2 and 8 weeks after surgery and by postal questionnaire at 8, 12 and 24 months after randomisation. MAIN OUTCOME MEASURES: The Oxford Shoulder Score (OSS) at 24 months was the primary outcome measure. Magnetic resonance imaging evaluation of the shoulder was made at 12 months after surgery to assess the integrity of the repair. RESULTS: The mean OSS improved from 26.3 [standard deviation (SD) 8.2] at baseline to 41.7 (SD 7.9) at 24 months for arthroscopic surgery and from 25.0 (SD 8.0) at baseline to 41.5 (SD 7.9) at 24 months for open surgery. When effect sizes are shown for the intervention, a negative sign indicates that an open procedure is favoured. For the intention-to-treat analysis, there was no statistical difference between the groups, the difference in OSS score at 24 months was -0.76 [95% confidence interval (CI) -2.75 to 1.22; p = 0.452] and the CI excluded the predetermined clinically important difference in the OSS of 3 points. There was also no statistical difference when the groups were compared per protocol (difference in OSS score -0.46, 95% CI -5.30 to 4.39; p = 0.854). The questionnaire response rate was > 86%. At 8 months, 77% of participants reported that shoulder problems were much or slightly better, and at 24 months this increased to 85%. There were no significant differences in mean cost between the arthroscopic group and the open repair group for any of the component resource-use categories, nor for the total follow-up costs at 24 months. The overall treatment cost at 2 years was £2567 (SD £176) for arthroscopic surgery and £2699 (SD £149) for open surgery, according to intention-to-treat analysis. For the per-protocol analysis there was a significant difference in total initial procedure-related costs between the arthroscopic group and the open repair group, with arthroscopic repair being more costly by £371 (95% CI £135 to £607). Total quality-adjusted life-years accrued at 24 months averaged 1.34 (SD 0.05) in the arthroscopic repair group and 1.35 (SD 0.05) in the open repair group, a non-significant difference of 0.01 (95% CI -0.11 to 0.10). The rate of re-tear was not significantly different across the randomised groups (46.4% and 38.6% for arthroscopic and open surgery, respectively). The participants with tears that were impossible to repair had the lowest OSSs, the participants with re-tears had slightly higher OSSs and the participants with healed repairs had the most improved OSSs. These findings were the same when analysed per protocol. CONCLUSION: In patients aged > 50 years with a degenerative rotator cuff tear there is no difference in clinical effectiveness or cost-effectiveness between open repair and arthroscopic repair at 2 years for the primary outcome (OSS) and all other prespecified secondary outcomes. Future work should explore new methods to improve tendon healing and reduce the high rate of re-tears observed in this trial. TRIAL REGISTRATION: Current Controlled Trials ISRCTN97804283. FUNDING: This project was funded by the National Institute for Health Research Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 19, No. 80. See the NIHR Journals Library website for further project information.

Floor and ceiling effects in the OHS: an analysis of the NHS PROMs data set.

OBJECTIVES: The objective was to examine whether the Oxford Hip Score (OHS) demonstrated a floor or a ceiling effect when used to measure the outcome of hip replacement surgery in a large national cohort. SETTING: Secondary database analysis of a national audit conducted in England and Wales on patient undergoing hip and knee arthroplasty in a secondary care setting. PARTICIPANTS: 93 253 primary arthroplasty patients completed preoperative OHS questionnaires and 69 361 completed 6-month postoperative OHS questionnaires. The population had a mean age of 67.78 (range 14-100, SD 11.3) and 59% were female. PRIMARY SECONDARY OUTCOME MEASURES: Primary outcome measure was the Oxford Hip Score (OHS). Secondary outcome measures were the OHS-FCS and OHS-PCS. Floor and ceiling effects were considered present if >15% of patients achieved the worst score/floor effect (0/48) or best/ceiling effect (48/48) score. RESULTS: Preoperatively, 0% of patients achieved the best score (48) and 0.1% achieved the worst score (0). Postoperatively, 0.1% patients achieved the worst score, but the percentage achieving the best score increased to 11.6%. Subgroup analyses demonstrated that patients between 50 and 59 years of age had the highest postoperative best score, at 15.3%. The highest postoperative OHS worst score percentage was in a group of patients who had a preoperative OHS above 41/48 at 28%. Furthermore, 22.6% of patients achieved the best postoperative OHS-PCS and 19.9% best postoperative OHS-FCS. CONCLUSIONS: Based on NHS PROMS data the overall OHS does not exhibit a ceiling or floor effect and should continue to be used as a valid measure of patient-reported outcomes for patients undergoing total hip arthroplasty. However, subscale analysis does indicate some limitations in the OHS-PCS and OHS-FCS. TRIAL REGISTRATION NUMBER: NDORMS. Introducing standardised and evidence-based thresholds for hip and knee replacement surgery. The Arthroplasty Candidacy Help Engine (ACHE tool). HTA Project 11/63/01.

Development of the Oxford Participation and Activities Questionnaire: constructing an item pool.

PURPOSE: The Oxford Participation and Activities Questionnaire is a patient-reported outcome measure in development that is grounded on the World Health Organization International Classification of Functioning, Disability, and Health (ICF). The study reported here aimed to inform and generate an item pool for the new measure, which is specifically designed for the assessment of participation and activity in patients experiencing a range of health conditions. METHODS: Items were informed through in-depth interviews conducted with 37 participants spanning a range of conditions. Interviews aimed to identify how their condition impacted their ability to participate in meaningful activities. Conditions included arthritis, cancer, chronic back pain, diabetes, motor neuron disease, multiple sclerosis, Parkinson's disease, and spinal cord injury. Transcripts were analyzed using the framework method. Statements relating to ICF themes were recast as questionnaire items and shown for review to an expert panel. Cognitive debrief interviews (n=13) were used to assess items for face and content validity. RESULTS: ICF themes relevant to activities and participation in everyday life were explored, and a total of 222 items formed the initial item pool. This item pool was refined by the research team and 28 generic items were mapped onto all nine chapters of the ICF construct, detailing activity and participation. Cognitive interviewing confirmed the questionnaire instructions, items, and response options were acceptable to participants. CONCLUSION: Using a clear conceptual basis to inform item generation, 28 items have been identified as suitable to undergo further psychometric testing. A large-scale postal survey will follow in order to refine the instrument further and to assess its psychometric properties. The final instrument is intended for use in clinical trials and interventions targeted at maintaining or improving activity and participation.

Meaningful changes for the Oxford hip and knee scores after joint replacement surgery.

OBJECTIVES: To present estimates of clinically meaningful or minimal important changes for the Oxford Hip Score (OHS) and the Oxford Knee Score (OKS) after joint replacement surgery. STUDY DESIGN AND SETTING: Secondary data analysis of the NHS patient-reported outcome measures data set that included 82,415 patients listed for hip replacement surgery and 94,015 patients listed for knee replacement surgery was performed. RESULTS: Anchor-based methods revealed that meaningful change indices at the group level [minimal important change (MIC)], for example in cohort studies, were ∼ 11 points for the OHS and ∼ 9 points for the OKS. For assessment of individual patients, receiver operating characteristic analysis produced MICs of 8 and 7 points for OHS and OKS, respectively. Additionally, the between group minimal important difference (MID), which allows the estimation of a clinically relevant difference in change scores from baseline when comparing two groups, that is, for clinical trials, was estimated to be ∼ 5 points for both the OKS and the OHS. The distribution-based minimal detectable change (MDC90) estimates for the OKS and OHS were 4 and 5 points, respectively. CONCLUSION: This study has produced and discussed estimates of minimal important change/difference for the OKS/OHS. These estimates should be used in the power calculations and the interpretation of studies using the OKS and OHS. The MDC90 (∼ 4 points OKS and ∼ 5 points OHS) represents the smallest possible detectable change for each of these instruments, thus indicating that any lower value would fall within measurement error.

Minimally important change was estimated for the Manchester-Oxford Foot Questionnaire after foot/ankle surgery.

OBJECTIVES: To ascertain the smallest amounts of change for the three Manchester-Oxford Foot Questionnaire (MOXFQ) domains that are likely to be clinically meaningful and beyond measurement error for conditions affecting the foot/ankle. Estimates were compared with those from the Short-Form 36 (SF-36). STUDY DESIGN AND SETTING: A prospective observational study of 671 consecutive patients undergoing foot or ankle surgery at an orthopedic hospital. Before and 9 months after surgery, patients completed the MOXFQ and SF-36; transition items (anchor) asked about perceived changes in foot/ankle pain or problems since the surgery. RESULTS: Four hundred ninety-one patients completed pre- and postoperative questionnaires. Anchor-based minimal clinically important change (MCIC) values were ~13 points for each of the MOXFQ Walking/standing (W/S), Pain, and Social Interaction (S-I) domains [and greater than the standard error of measurement (SEM)]. MCIC values for all SF-36 domains fell within the SEM. Between-group MCIDs for the MOXFQ were W/S, 16.2; Pain, 9.9; S-I, 9.3. Distribution-based minimal detectable change (MDC90) values for the MOXFQ were ~11, ~12, and ~16 score points for the W/S, Pain, and S-I scales, respectively. CONCLUSION: This article provides information for aiding the interpretability of MOXFQ outcomes data and for planning future studies. The SF-36 is not recommended as a primary outcome for foot/ankle surgery.

Management of cancer pain: 1. Wider implications of orthodox analgesics.

In this review, the first of two parts, we first provide an overview of the orthodox analgesics used commonly against cancer pain. Then, we examine in more detail the emerging evidence for the potential impact of analgesic use on cancer risk and disease progression. Increasing findings suggest that long-term use of nonsteroidal anti-inflammatory drugs, particularly aspirin, may reduce cancer occurrence. However, acetaminophen may raise the risk of some hematological malignancies. Drugs acting upon receptors of gamma-aminobutyric acid (GABA) and GABA "mimetics" (eg, gabapentin) appear generally safe for cancer patients, but there is some evidence of potential carcinogenicity. Some barbiturates appear to slightly raise cancer risks and can affect cancer cell behavior in vitro. For cannabis, studies suggest an increased risk of squamous cell carcinoma of the tongue, larynx, and possibly lung. Morphine may stimulate human microvascular endothelial cell proliferation and angiogenesis; it is not clear whether this might cause harm or produce benefit. The opioid, fentanyl, may promote growth in some tumor cell lines. Opium itself is an emerging risk factor for gastric adenocarcinoma and possibly cancers of the esophagus, bladder, larynx, and lung. It is concluded that analgesics currently prescribed for cancer pain can significantly affect the cancer process itself. More futuristically, several ion channels are being targeted with novel analgesics, but many of these are also involved in primary and/or secondary tumorigenesis. Further studies are needed to elucidate possible cellular and molecular effects of orthodox analgesics and their possible long-term impact, both positive and negative, and thus enable the best possible clinical gain for cancer patients.

What is the optimal time point to assess patient-reported recovery after hip and knee replacement? A systematic review and analysis of routinely reported outcome data from the English patient-reported outcome measures programme.

BACKGROUND: It is unclear if there is a clinically important improvement in the six to 12-month recovery period after hip and knee replacement. This is an obvious gap in the evidence required by patients undergoing these procedures. It is also an issue for the English PROMs (Patient-Reported Outcome Measures) Programme which uses 6-month outcome data to compare the results of hospitals that perform hip and knee replacements. METHODS: A systematic review of studies reporting the Oxford Hip Score (OHS) or Oxford Knee Score (OKS) at 12 months after surgery was performed. This was compared with six-month outcome data collected for 60, 160 patients within the English PROMs programme. A minimally important difference of one standard error of the measurement, equivalent to 2.7 for the OHS and 2.1 for the OKS, was adopted. RESULTS AND DISCUSSION: Six studies reported OHS data for 10 different groups containing 8,308 patients in total. In eight groups the change scores reported were at least 2.7 points higher than the six-month change observed in the PROMs programme (20.2 points). Nine studies reported OKS data for 13 different groups containing 4,369 patients in total. In eight groups the change scores reported were at least 2.1 points higher than the six-month change observed in the PROMs programme (15.0 points). CONCLUSIONS: There is some evidence from this systematic review that clinically important improvement in the Oxford hip and knee scores occurs in the six to 12 month recovery period. This trend is more apparent for hip than knee replacement. Therefore we recommend that the English Department of Health study the impact on hospital comparisons of using 12- rather than six-month outcome data.

Can pain and function be distinguished in the Oxford Knee Score in a meaningful way? An exploratory and confirmatory factor analysis.

PURPOSE: The purpose of this paper was to examine if pain and functioning can be distinguished in the Oxford Knee Score (OKS) in a meaningful way. This was done by (1) conducting exploratory factor analysis to explore the factorial structure of the OKS and (2) conducting confirmatory factor analysis to examine whether a two-factor solution is superior to a one-factor solution. METHODS: Secondary data analysis of four independent datasets containing OKS scores on 161,973 patients was performed. Four independent datasets contained data on: (1) 156, 788 patients from the NHS HES/PROMS dataset, (2) 2,405 consecutive patients from the South West London Elective Operating Centre, (3) 2,353 patients enrolled in the Knee Arthroplasty Trial and (4) 427 consecutive patients listed for knee replacement surgery at the Nuffield Orthopaedic Centre in Oxford. RESULTS: Factor extraction methods suggested that, depending on the method employed, both one- and two-factor solutions are meaningful. Overall and in each data set some cross-loading occurred and item loadings were consistent across two factors. On confirmatory factor analysis, both one- and two-factor models had acceptable fit indices. This allowed the creation of the 'OKS pain component' and the 'OKS functional component' subscales. CONCLUSIONS: Factor analysis confirmed the original conceptual basis of the OKS but offered an option to perform additional analyses using pain and functional subscales. Further research should focus on providing further evidence on construct validity and responsiveness of the newly derived subscales.

Factors associated with patient satisfaction with foot and ankle surgery in a large prospective study.

BACKGROUND: There is minimal published research on outcomes and satisfaction with foot and ankle surgery. OBJECTIVE: To investigate patient-reported outcomes and satisfaction, and investigate which factors influence satisfaction at 9 months following foot or ankle surgery. METHODS: Prospective study of 671 adult patients having foot or ankle surgery. Pre-and post-surgery, patients self-completed MOXFQ, SF-36 and EQ-5D questionnaires. Using ratings to a satisfaction item, patients who were 'very pleased' with the outcome were compared with everyone else, using multiple logistic regression, regarding their pre-, peri- and post-operative characteristics. RESULTS: Of 628 eligible patients, 491 (73%) completed pre-and post-operative questionnaires. Following adjustment, satisfaction with surgery was influenced by patients' perceptions of their foot/ankle's appearance (OR 0.12, 95% CIs 0.06-0.23, p<0.001); wearable range of shoes (OR 0.36, 95% CIs 0.17-0.79, p=0.01); continued foot/ankle pain (OR 0.06, 95% CIs 0.03-0.14, p<0.001); impairment in Social-Interaction (MOXFQ SI scale) (OR 0.98, 95% CIs 0.96-0.99, p=0.009). The final explanatory model explained 67% of the variance in patient satisfaction. CONCLUSIONS: Foot appearance, wearable shoe range, the (full) alleviation of pain and the ability/confidence to interact socially are crucial to peoples' satisfaction with their foot or ankle surgery.

A scoring system for the foot and ankle that is acceptable, reliable, valid and responsive.

We read with interest the recent paper by Groarke et al. (Quality of life in individuals with chronic foot conditions: a cross sectional observational study. The Foot (2012) doi:10.1016/i.foot.2011.11.007). The paper ended by stating that 'there is no scoring system for the foot and ankle that is valid, repeatable and reliable'. This statement is misleading. The authors could have made reference to the patient-reported Manchester-Oxford Foot Questionnaire (MOXFQ). The MOXFQ has been subjected to more rigorous testing of its measurement properties than is the case for most instruments, and has been demonstrated to be acceptable, reliable, valid and responsive in the context of foot or ankle surgery.