Transcendent Experiences Among Pilgrims to Lourdes: A Qualitative Investigation.

Millions of pilgrims visit Lourdes each year, often seeking revitalisation rather than miraculous cures. We sought to understand the phenomenon of transcendent experiences. We spoke with 67 pilgrims including assisted pilgrims, young volunteers and medical staff. About two in five reported a transcendent experience: some felt they had communicated or had close contact with a divine presence, while others reported a powerful experience of something intangible and otherworldly. Transcendent experiences are an important feature of pilgrimage to Lourdes and the place offers the faithful a means of connecting with the divine, with nature and with the self.

Factors associated with implant survival following total hip replacement surgery: A registry study of data from the National Joint Registry of England, Wales, Northern Ireland and the Isle of Man.

BACKGROUND: Nearly 100,000 people underwent total hip replacement (THR) in the United Kingdom in 2018, and most can expect it to last at least 25 years. However, some THRs fail and require revision surgery, which results in worse outcomes for the patient and is costly to the health service. Variation in the survival of THR implants has been observed between units and reducing this unwarranted variation is one focus of the "Getting it Right First Time" (GIRFT) program in the UK. We aimed to investigate whether the statistically improved implant survival of THRs in a high-performing unit is associated with the implants used or other factors at that unit, such as surgical skill. METHODS AND FINDINGS: We analyzed a national, mandatory, prospective, cohort study (National Joint Registry for England, Wales, Northern Ireland and the Isle of Man [NJR]) of all THRs performed in England and Wales. We included the 664,761 patients with records in the NJR who have received a stemmed primary THR between 1 April 2003 and 31 December 2017 in one of 461 hospitals, with osteoarthritis as the only indication. The exposure was the unit (hospital) in which the THR was implanted. We compared survival of THRs implanted in the "exemplar" unit with THRs implanted anywhere else in the registry. The outcome was revision surgery of any part of the THR construct for any reason. Net failure was calculated using Kaplan-Meier estimates, and adjusted analyses employed flexible parametric survival analysis. The mean age of patients contributing to our analyses was 69.9 years (SD 10.1), and 61.1% were female. Crude analyses including all THRs demonstrated better implant survival at the exemplar unit with an all-cause construct failure of 1.7% (95% CI 1.3-2.3) compared with 2.9% (95% CI 2.8-3.0) in the rest of the country after 13.9 years (log-rank test P < 0.001). The same was seen in analyses adjusted for age, sex, and American Society of Anesthesiology (ASA) score (difference in restricted mean survival time 0.12 years [95% CI 0.07-0.16; P < 0.001]). Adjusted analyses restricted to the same implants as the exemplar unit show no demonstrable difference in restricted mean survival time between groups after 13.9 years (P = 0.34). A limitation is that this study is observational and conclusions regarding causality cannot be inferred. Our outcome is revision surgery, and although important, we recognize it is not the only marker of success of a THR. CONCLUSIONS: Our results suggest that the "better than expected" implant survival results of this exemplar center are associated with implant choice. The survival results may be replicated by adopting key treatment decisions, such as implant selection. These decisions are easier to replicate than technical skills or system factors.

Room for improvement: a randomised controlled trial with nested qualitative interviews on space, place and treatment delivery.

OBJECTIVE: Healthcare-oriented design in hospitals can promote better clinical outcomes. Creating optimal facilities may increase treatment effects. We investigated the influence of the treatment room on effects of exercise therapy. METHODS: In a mixed-method randomised controlled double-blind trial, middle-aged individuals reporting knee or hip pain performed 8 weeks of exercise therapy in (1) a newly built physically enhanced environment, (2) a standard environment or (3) were waitlisted, receiving no intervention. Participants and therapists were blind to study aim. Primary outcome was participants' Global Perceived Effect (GPE; seven-point Likert scale). Six nested focus group interviews with participants (n=25) and individual interviews with therapists (n=2) explored experiences of the environments. RESULTS: 42 people exercised in the physically enhanced environment, 40 in the standard environment, 21 were waitlisted. Contrary to our hypothesis, the treatment response seemed greater in the standard environment for GPE (0.98, 95% CI0.5 to 1.4) than for the physically enhanced environment (0.37, 95% CI -0.2 to 0.9), between-group difference (0.61, 95% CI -0.1 to 1.3) did not reach statistical significance (p=0.07). Waitlist group reported no improvement (-0.05 95% CI -0.5 to 0.4). In interviews, participants from the standard environment expressed greater social cohesion and feeling at home. Qualitative themes identified; reflection, sense of fellowship and transition. Secondary patient-reported outcomes and qualitative findings supported the primary finding, while improvements in muscle strength and aerobic capacity did not differ between exercise groups. CONCLUSION: Results suggest that the physical environment contributes to treatment response. Matching patients' preferences to treatment rooms may improve patient-reported outcomes. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov identifier: NCT02043613.

One- and two-stage surgical revision of peri-prosthetic joint infection of the hip: a pooled individual participant data analysis of 44 cohort studies.

One-stage and two-stage revision strategies are the two main options for treating established chronic peri-prosthetic joint infection (PJI) of the hip; however, there is uncertainty regarding which is the best treatment option. We aimed to compare the risk of re-infection between the two revision strategies using pooled individual participant data (IPD). Observational cohort studies with PJI of the hip treated exclusively by one- or two-stage revision and reporting re-infection outcomes were retrieved by searching MEDLINE, EMBASE, Web of Science, The Cochrane Library, and the WHO International Clinical Trials Registry Platform; as well as email contact with investigators. We analysed IPD of 1856 participants with PJI of the hip from 44 cohorts across four continents. The primary outcome was re-infection (recurrence of infection by the same organism(s) and/or re-infection with a new organism(s)). Hazard ratios (HRs) for re-infection were calculated using Cox proportional frailty hazards models. After a median follow-up of 3.7 years, 222 re-infections were recorded. Re-infection rates per 1000 person-years of follow-up were 16.8 (95% CI 13.6-20.7) and 32.3 (95% CI 27.3-38.3) for one-stage and two-stage strategies respectively. The age- and sex-adjusted HR of re-infection for two-stage revision was 1.70 (0.58-5.00) when compared with one-stage revision. The association remained consistently absent after further adjustment for potential confounders. The HRs did not vary importantly in clinically relevant subgroups. Analysis of pooled individual patient data suggest that a one-stage revision strategy may be as effective as a two-stage revision strategy in treating PJI of the hip.

45-day mortality after 467,779 knee replacements for osteoarthritis from the National Joint Registry for England and Wales: an observational study.

BACKGROUND: Understanding the risk factors for early death after knee replacement could help to reduce the risk of mortality after this procedure. We assessed secular trends in death within 45 days of knee replacement for osteoarthritis in England and Wales, with the aim of investigating whether any change that we recorded could be explained by alterations in modifiable perioperative factors. METHODS: We took data for knee replacements done for osteoarthritis in England and Wales between April 1, 2003, and Dec 31, 2011, from the National Joint Registry for England and Wales. Patient identifiers were used to link these data to the national mortality database and the Hospital Episode Statistics database to obtain details of death, sociodemographics, and comorbidity. We assessed mortality within 45 days by Kaplan-Meier analysis and assessed the role of patient and treatment factors by Cox proportional hazards models. FINDINGS: 467,779 primary knee replacements were done to treat osteoarthritis during 9 years. 1183 patients died within 45 days of surgery, with a substantial secular decrease in mortality from 0·37% in 2003 to 0·20% in 2011, even after adjustment for age, sex, and comorbidity. The use of unicompartmental knee replacement was associated with substantially lower mortality than was total knee replacement (hazard ratio [HR] 0·32, 95% CI 0·19­0·54, p<0·0005). Several comorbidities were associated with increased mortality: myocardial infarction (HR 3·46, 95% CI 2·81­4·14, p<0·0005), cerebrovascular disease (3·35, 2·7­4·14, p<0·0005), moderate/severe liver disease (7·2, 3·93­13·21, p<0·0005), and renal disease (2·18, 1·76­2·69, p<0·0005). Modifiable perioperative risk factors, including surgical approach and thromboprophylaxis were not associated with mortality. INTERPRETATION: Postoperative mortality after knee replacement has fallen substantially between 2003 and 2011. Efforts to further reduce mortality should concentrate more on older patients, those who are male and those with specific comorbidities, such as myocardial infarction, cerebrovascular disease, liver disease, and renal disease. FUNDING: National Joint Registry for England and Wales.

90-day mortality after 409,096 total hip replacements for osteoarthritis, from the National Joint Registry for England and Wales: a retrospective analysis.

BACKGROUND: Death within 90 days after total hip replacement is rare but might be avoidable dependent on patient and treatment factors. We assessed whether a secular decrease in death caused by hip replacement has occurred in England and Wales and whether modifiable perioperative factors exist that could reduce deaths. METHODS: We took data about hip replacements done in England and Wales between April, 2003, and December, 2011, from the National Joint Registry for England and Wales. Patient identifiers were used to link these data to the national mortality database and the Hospital Episode Statistics database to obtain details of death, sociodemographics, and comorbidity. We assessed mortality within 90 days of operation by Kaplan-Meier analysis and assessed the role of patient and treatment factors by Cox proportional hazards model. FINDINGS: 409,096 primary hip replacements were done to treat osteoarthritis. 1743 patients died within 90 days of surgery during 8 years, with a substantial secular decrease in mortality, from 0·56% in 2003 to 0·29% in 2011, even after adjustment for age, sex, and comorbidity. Several modifiable clinical factors were associated with decreased mortality according to an adjusted model: posterior surgical approach (hazard ratio [HR] 0·82, 95% CI 0·73-0·92; p=0·001), mechanical thromboprophylaxis (0·85, 0·74-0·99; p=0·036), chemical thromboprophylaxis with heparin with or without aspirin (0·79, 0·66-0·93; p=0·005), and spinal versus general anaesthetic (0·85, 0·74-0·97; p=0·019). Type of prosthesis was unrelated to mortality. Being overweight was associated with lower mortality (0·76, 0·62-0·92; p=0·006). INTERPRETATION: Postoperative mortality after hip joint replacement has fallen substantially. Widespread adoption of four simple clinical management strategies (posterior surgical approach, mechanical and chemical prophylaxis, and spinal anaesthesia) could, if causally related, reduce mortality further. FUNDING: National Joint Registry for England and Wales.

'And the pain just disappeared into insignificance': The healing response in Lourdes - Performance, psychology and caring.

Three academic/practitioners from different disciplines (performance, medicine and psychology) describe the ways in which observing, and importantly, participating in the healing rituals of the French pilgrimage site of Lourdes challenged their ways of thinking about both their discipline's research approaches and their understandings of community, caring and healing. By positioning themselves as both first-person and third-person researchers, they suggest that a new type of 'trans-disciplinary', longitudinal, reflexively sensitive methodology is needed in order to investigate activities involving groups of people and spiritual practices as a whole system in order to better understand how they can positively affect our innate healing response.

Failure rates of metal-on-metal hip resurfacings: analysis of data from the National Joint Registry for England and Wales.

BACKGROUND: Implant survival after conventional total hip replacement (THR) is often poor in younger patients, so alternatives such as hip resurfacing, with various sizes to fit over the femoral head, have been explored. We assessed the survival of different sizes of metal-on-metal resurfacing in men and women, and compared this survival with those for conventional stemmed THRs. METHODS: We analysed the National Joint Registry for England and Wales (NJR) for primary THRs undertaken between 2003 and 2011. Our analysis involved multivariable flexible parametric survival models to estimate the covariate-adjusted cumulative incidence of revision adjusting for the competing risk of death. FINDINGS: The registry included 434,560 primary THRs, of which 31,932 were resurfacings. In women, resurfacing resulted in worse implant survival than did conventional THR irrespective of head size. Predicted 5-year revision rates in 55-year-old women were 8·3% (95% CI 7·2-9·7) with a 42 mm resurfacing head, 6·1% (5·3-7·0) with a 46 mm resurfacing head, and 1·5% (0·8-2·6) with a 28 mm cemented metal-on-polyethylene stemmed THR. In men with smaller femoral heads, resurfacing resulted in poor implant survival. Predicted 5-year revision rates in 55-year-old men were 4·1% (3·3-4·9) with a 46 mm resurfacing head, 2·6% (2·2-3·1) with a 54 mm resurfacing head, and 1·9% (1·5-2·4) with a 28 mm cemented metal-on-polyethylene stemmed THR. Of male resurfacing patients, only 23% (5085 of 22076) had head sizes of 54 mm or above. INTERPRETATION: Hip resurfacing only resulted in similar implant survivorship to other surgical options in men with large femoral heads, and inferior implant survivorship in other patients, particularly women. We recommend that resurfacing is not undertaken in women and that preoperative measurement is used to assess suitability in men. Before further new implant technology is introduced we need to learn the lessons from resurfacing and metal-on-metal bearings. FUNDING: National Joint Registry for England and Wales.

Failure rates of stemmed metal-on-metal hip replacements: analysis of data from the National Joint Registry of England and Wales.

BACKGROUND: Total hip replacement (THR) is extremely common. Some prostheses fail, particularly in younger patients, and need to be revised, most commonly for loosening secondary to wear or dislocation. Surgeons have tried to address these problems by implanting large diameter metal-on-metal bearing surfaces. Our aim was to assess if metal-on-metal bearing surfaces lead to increased implant survival compared with other bearing surfaces in stemmed THR and, additionally, if larger head sizes result in improved implant survival. METHODS: We analysed the National Joint Registry of England and Wales for primary hip replacements (402,051, of which 31,171 were stemmed metal-on-metal) undertaken between 2003 and 2011. Our analysis was with a multivariable flexible parametric survival model to estimate the covariate-adjusted cumulative incidence of revision adjusting for the competing risk of death. FINDINGS: Metal-on-metal THR failed at high rates. Failure was related to head size, with larger heads failing earlier (3·2% cumulative incidence of revision [95% CI 2·5-4·1] for 28 mm and 5·1% [4·2-6·2] for 52 mm head at 5 years in men aged 60 years). 5 year revision rates in younger women were 6·1% (5·2-7·2) for 46 mm metal-on-metal compared with 1·6% (1·3-2·1) for 28 mm metal-on-polyethylene. By contrast, for ceramic-on-ceramic articulations larger head sizes were associated with improved survival (5 year revision rate of 3·3% [2·6-4·1] with 28 mm and 2·0% [1·5-2·7] with 40 mm for men aged 60 years). INTERPRETATION: Metal-on-metal stemmed articulations give poor implant survival compared with other options and should not be implanted. All patients with these bearings should be carefully monitored, particularly young women implanted with large diameter heads. Since large diameter ceramic-on-ceramic bearings seem to do well we support their continued use. FUNDING: National Joint Registry of England and Wales.

High bone mass is associated with an increased prevalence of joint replacement: a case-control study.

OBJECTIVE: Epidemiological studies have shown an association between OA and increased BMD. To explore the nature of this relationship, we examined whether the risk of OA is increased in individuals with high bone mass (HBM), in whom BMD is assumed to be elevated due to a primary genetic cause. METHODS: A total of 335,115 DXA scans were screened to identify HBM index cases (defined by DXA scan as an L1 Z-score of ≥+3.2 and total hip Z-score ≥+1.2, or total hip Z-score ≥+3.2 and L1 Z-score ≥+1.2). In relatives, the definition of HBM was L1 Z-score plus total hip Z-score ≥+3.2. Controls comprised unaffected relatives and spouses. Clinical indicators of OA were determined by structured assessment. Analyses used logistic regression adjusting for age, gender, BMI and social deprivation. RESULTS: A total of 353 HBM cases (mean age 61.7 years, 77% female) and 197 controls (mean age 54.1 years, 47% female) were included. Adjusted NSAID use was more prevalent in HBM cases versus controls [odds ratio (OR) 2.17 (95% CI 1.10, 4.28); P = 0.03]. The prevalence of joint replacement was higher in HBM cases (13.0%) than controls (4.1%), with an adjusted OR of 2.42 (95% CI 1.06, 5.56); P = 0.04. Adjusted prevalence of joint pain and knee crepitus did not differ between cases and controls. CONCLUSION: HBM is associated with increased prevalence of joint replacement surgery and NSAID use compared with unaffected controls.

Medical education: a particularly complex intervention to research.

Previous debate has explored whether medical education research should become more like health services research in terms of frameworks, collaborations and methodologies. Notable recent changes in health services research include an increasing emphasis on complex interventions, defined as interventions that involve more than one component. The purpose of this study was to explore the extent of thinking about medical education as a complex intervention and to analyse medical education research to determine whether its collaborations and methodologies are becoming more like health services research. Research articles published in three journals over 2 years were analysed to determine the purpose of the research in relation to a framework for evaluating complex interventions, the degree of collaboration, and the methodology. Most studies aimed to develop theory or assess effectiveness and many categories of the complex interventions framework were not represented in the medical education research literature. Studies usually involved only one research site and were predominantly quantitative but not experimental or quasi-experimental. Whilst medical education research has not moved significantly in the direction of health services research over recent years, the complex interventions lens provided insights into why this might be so (namely the significant challenges associated with researching medical education). We recommend that medical education researchers work within a complex interventions framework and look to research fields with similar challenges (e.g. the study of chronic illness in a changing context) for ideas about theories, frameworks, methodologies and collaborations that can illuminate the field of medical education research.

Trust in the health-care provider-patient relationship: a systematic mapping review of the evidence base.

PURPOSE: Trust is important for patients and may be used as an indicator and potential 'marker' for how patients evaluate the quality of health care. The review aimed to classify the current evidence base on trust in the patient-provider relationship in order to identify strengths and weaknesses and to point towards areas for future research. DATA SOURCES: Nine electronic databases were searched from 2004 onwards using text and subject heading keywords relating to 'trust' and 'health care' and 'relationships'. STUDY SELECTION: Abstracts were identified for empirical studies carried out in health-care settings that explicitly examined trust or reported trust-related findings as a secondary outcome. Data extraction Two review authors assessed the relevance of abstracts and extracted data relating to year published, country of study, clinical speciality, STUDY DESIGN: and participants. RESULTS OF DATA SYNTHESIS: Five hundred and ninety-six abstracts were included. Most reported on patients' trust in providers; were carried out in the USA; collected data in family care or oncology/palliative care settings; used questionnaires and interviews and elicited patients' perspectives. Only one study explicitly set out to examine providers' trust in patients and <5% of included studies reported on providers' trust in patients. CONCLUSION: Providers' trust in patients remains a neglected area on the trust research agenda. Empirical studies examining the factors that influence providers' trust in patients and how this might affect the quality of care and patient health-related behaviours are urgently needed to readdress this imbalance. Further exploration of this area using observational methods is recommended.

Somatosensory abnormalities in knee OA.

OBJECTIVE: The aim of this study was to use quantitative sensory testing (QST) to explore the range and prevalence of somatosensory abnormalities demonstrated by patients with advanced knee OA. METHODS: One hundred and seven knee OA patients and 50 age- and sex-matched healthy participants attended a 1-h QST session. Testing was performed on the medial side of the knee and the pain-free forearm. Light-touch thresholds were assessed using von Frey filaments, pressure pain thresholds using a digital pressure algometer, and thermal sensation and pain thresholds using a Thermotest MSA. Significant differences in median threshold values from knee OA patients and healthy participants were identified using Mann-Whitney U-tests. The z-score transformations were used to determine the prevalence of the different somatosensory abnormalities in knee OA patients. RESULTS: Testing identified 70% of knee OA patients as having at least one somatosensory abnormality. Comparison of median threshold values between knee OA patients and healthy participants revealed that patients had localized thermal and tactile hypoaesthesia and pressure hyperalgesia at the osteoarthritic knee. Tactile hypoaesthesia and pressure hyperalgesia were also present at the pain-free forearm. The most prevalent somatosensory abnormalities were tactile hypoaesthesia and pressure hyperalgesia, evident in between 20 and 34% of patients. CONCLUSION: This study found that OA patients demonstrate an array of somatosensory abnormalities, of which the most prevalent were tactile hypoaesthesia and pressure hyperalgesia. Further research is now needed to establish the clinical implications of these somatosensory abnormalities.

Predictors of outcomes of total knee replacement surgery.

OBJECTIVE: To identify pre-operative predictors of patient-reported outcomes of primary total knee replacement (TKR) surgery. METHODS: The Elective Orthopaedic Centre database is a large prospective cohort of 1991 patients receiving primary TKR in south-west London from 2005 to 2008. The primary outcome is the 6-month post-operative Oxford Knee Score (OKS). To classify whether patients had a clinically important outcome, we calculated a patient acceptable symptom state (PASS) for the 6-month OKS related to satisfaction with surgery. Potential predictor variables were pre-operative OKS, age, sex, BMI, deprivation, surgical side, diagnosis, operation type, American Society of Anesthesiologists grade and EQ5D anxiety/depression. Regression modelling was used to identify predictors of outcome. RESULTS: The strongest determinants of outcome include pre-operative pain/function-those with less severe pre-operative disease obtain the best outcomes; diagnosis in relation to pain outcome-patients with RA did better than those with OA; deprivation-those living in poorer areas had worse outcomes; and anxiety/depression-worse pre-operative anxiety/depression led to worse pain. Differences were observed between predictors of pain and functional outcomes. Diagnosis of RA and anxiety/depression were associated with pain, whereas age and gender were specifically associated with function. BMI was not a clinically important predictor of outcome. CONCLUSION: This study identified clinically important predictors of attained pain/function post-TKR. Predictors of pain were not necessarily the same as functional outcomes, which may be important in the context of a patient's expectations of surgery. Other predictive factors need to be identified to improve our ability to recognize patients at risk of poor TKR outcomes.

Assessing function in patients undergoing joint replacement: a study protocol for a cohort study.

BACKGROUND: Joint replacement is an effective intervention for people with advanced arthritis, although there is an important minority of patients who do not improve post-operatively. There is a need for robust evidence on outcomes after surgery, but there are a number of measures that assess function after joint replacement, many of which lack any clear theoretical basis. The World Health Organisation has introduced the International Classification of Functioning, Disability and Health (ICF), which divides function into three separate domains: Impairment, activity limitations and participation restrictions. The aim of this study is to compare the properties and responsiveness of a selection of commonly used outcome tools that assess function, examine how well they relate to the ICF concepts, and to explore the changes in the measures over time. METHODS/DESIGN: Two hundred and sixty three patients listed for lower limb joint replacement at an elective orthopaedic centre have been recruited into this study. Participants attend the hospital for a research appointment prior to surgery and then at 3-months and 1-year after surgery. At each assessment time, function is assessed using a range of measures. Self-report function is assessed using the WOMAC, Aberdeen Impairment, Activity Limitation and Participation Restriction Measure, SF-12 and Measure Yourself Medical Outcome Profile 2. Clinician-administered measures of function include the American Knee Society Score for knee patients and the Harris Hip Score for hip patients. Performance tests include the timed 20-metre walk, timed get up and go, sit-to-stand-to-sit, step tests and single stance balance test. During the performance tests, participants wear an inertial sensor and data from motion analysis are collected. Statistical analysis will include exploring the relationship between measures describing the same ICF concepts, assessing responsiveness, and studying changes in measures over time. DISCUSSION: There are a range of tools that can be used to assess function before and after joint replacement, with little information about how these various measures compare in their properties and responsiveness. This study aims to provide this data on a selection of commonly used assessments of function, and explore how they relate to the ICF domains.

Association of bone attrition with knee pain, stiffness and disability: a cross-sectional study.

OBJECTIVES: Bone pathologies as detected on MRI are associated with the presence of pain in knee osteoarthritis (OA). The authors examined whether bone attrition assessed on x-rays was associated with pain, stiffness and disability. METHODS: The authors analysed x-rays of 1326 knees with OA from 783 individuals participating in the cross-sectional population-based Somerset and Avon Survey of Health. The diagnosis of OA was defined by the presence of osteophytes in anteroposterior (AP) or lateral views. Bone attrition was graded from 0 (no attrition) to 3 (severe attrition >10 mm) and Kellgren and Lawrence (K/L) scores were assigned on AP views. Logistic regression models adjusted for gender, age, body mass index, effusion and K/L scores were used to determine whether bone attrition was associated with pain, stiffness and disability. RESULTS: Pain was reported in 84 knees (74%) with radiographic bone attrition compared with 505 (42%) without bone attrition (adjusted OR 2.22, 95% CI 1.29 to 3.80). The adjusted OR was increased for day pain but not for night pain (p for interaction <0.001). Stiffness was reported for 85 knees with bone attrition (75%) and 437 knees without (36%) (adjusted OR 3.23, 95% CI 1.85 to 5.64). Disability was reported by 40 individuals with bone attrition (50%) and 140 individuals without (24%) (adjusted OR 2.09, 95% CI 1.19 to 3.68). CONCLUSIONS: Bone attrition detected on conventional x-rays using a simple cheap technique is strongly associated with the presence of day pain, stiffness and disability in knee OA.

Exploring the relationships between International Classification of Functioning, Disability and Health (ICF) constructs of Impairment, Activity Limitation and Participation Restriction in people with osteoarthritis prior to joint replacement.

BACKGROUND: The International Classification of Functioning, Disability and Health (ICF) proposes three main constructs, impairment (I), activity limitation (A) and participation restriction (P). The ICF model allows for all paths between the constructs to be explored, with significant paths likely to vary for different conditions. The relationships between I, A and P have been explored in some conditions but not previously in people with osteoarthritis prior to joint replacement. The aim of this paper is to examine these relationships using separate measures of each construct and structural equation modelling. METHODS: A geographical cohort of 413 patients with osteoarthritis about to undergo hip and knee joint replacement completed the Aberdeen measures of Impairment, Activity Limitation and Participation Restriction (Ab-IAP). Confirmatory factor analysis was used to test the three factor (I, A, P) measurement model. Structural equation modelling was used to explore the I, A and P pathways in the ICF model. RESULTS: There was support from confirmatory factor analysis for the three factor I, A, P measurement model. The structural equation model had good fit [S-B Chi-square = 439.45, df = 149, CFI robust = 0.91, RMSEA robust = 0.07] and indicated significant pathways between I and A (standardised coefficient = 0.76 p < 0.0001) and between A and P (standardised coefficient = 0.75 p < 0.0001). However, the path between I and P was not significant (standardised coefficient = 0.01). CONCLUSION: The significant pathways suggest that treatments and interventions aimed at reducing impairment, such as joint replacement, may only affect P indirectly, through A, however, longitudinal data would be needed to establish this.

The effect of local anaesthetic wound infiltration on chronic pain after lower limb joint replacement: a protocol for a double-blind randomised controlled trial.

BACKGROUND: For the majority of patients with osteoarthritis (OA), joint replacement is a successful intervention for relieving chronic joint pain. However, between 10-30% of patients continue to experience chronic pain after joint replacement. Evidence suggests that a risk factor for chronic pain after joint replacement is the severity of acute post-operative pain. The aim of this randomised controlled trial (RCT) is to determine if intra-operative local anaesthetic wound infiltration additional to a standard anaesthesia regimen can reduce the severity of joint pain at 12-months after total knee replacement (TKR) and total hip replacement (THR) for OA. METHODS: 300 TKR patients and 300 THR patients are being recruited into this single-centre double-blind RCT. Participants are recruited before surgery and randomised to either the standard care group or the intervention group. Participants and outcome assessors are blind to treatment allocation throughout the study. The intervention consists of an intra-operative local anaesthetic wound infiltration, consisting of 60 mls of 0.25% bupivacaine with 1 in 200,000 adrenaline. Participants are assessed on the first 5 days post-operative, and then at 3-months, 6-months and 12-months. The primary outcome is the WOMAC Pain Scale, a validated measure of joint pain at 12-months. Secondary outcomes include pain severity during the in-patient stay, post-operative nausea and vomiting, satisfaction with pain relief, length of hospital stay, joint pain and disability, pain sensitivity, complications and cost-effectiveness. A nested qualitative study within the RCT will examine the acceptability and feasibility of the intervention for both patients and healthcare professionals. DISCUSSION: Large-scale RCTs assessing the effectiveness of a surgical intervention are uncommon, particularly in orthopaedics. The results from this trial will inform evidence-based recommendations for both short-term and long-term pain management after lower limb joint replacement. If a local anaesthetic wound infiltration is found to be an effective and cost-effective intervention, implementation into clinical practice could improve long-term pain outcomes for patients undergoing lower limb joint replacement. TRIAL REGISTRATION: Current Controlled Trials ISRCTN96095682.

Systematic review: accuracy of anti-citrullinated Peptide antibodies for diagnosing rheumatoid arthritis.

BACKGROUND: Early recognition and treatment of rheumatoid arthritis is important to prevent irreversible joint damage. Anti-citrullinated peptide antibodies (ACPA) have been suggested for early diagnosis. PURPOSE: To compare the accuracy of ACPA and rheumatoid factor in diagnosing rheumatoid arthritis in patients with early symptoms of the disease. DATA SOURCES: 10 medical databases from inception to September 2009, with no language or publication restrictions, and references of included studies. STUDY SELECTION: Two independent reviewers screened searches. Full articles were assessed by one reviewer and checked by a second reviewer to identify studies that reported 2 x 2 data on ACPA for the diagnosis of rheumatoid arthritis (by 1987 American College of Rheumatology criteria). DATA EXTRACTION: One reviewer abstracted data on patient characteristics, ACPA details, and 2 x 2 data and assessed study quality by using the QUADAS tool. A second reviewer checked extractions. DATA SYNTHESIS: 151 studies were included, with considerable heterogeneity in sensitivity (range, 12% to 93%) and specificity (range, 63% to 100%). In cohort studies that investigated second-generation anti-cyclic citrullinated peptide antibodies (anti-CCP2) in patients with early rheumatoid arthritis (<2 years), summary sensitivity and specificity were 57% (95% CI, 51% to 63%) and 96% (CI, 93% to 97%), respectively. Case-control and cross-sectional studies and studies of patients with established rheumatoid arthritis all overestimated sensitivity. Anti-CCP2 had greater specificity than rheumatoid factor (96% vs. 86%), with similar sensitivity. Evidence was insufficient to ascertain whether the combination of anti-CCP2 and rheumatoid factor provides additional benefit over anti-CCP2 alone. LIMITATIONS: Most studies used a diagnostic case-control design, which overestimated sensitivity. Items relating to study quality were rarely reported. Publication bias could not be assessed. CONCLUSION: Anti-CCP2 should be included in the work-up of patients with early symptoms of rheumatoid arthritis.

Unstated factors in orthopaedic decision-making: a qualitative study.

BACKGROUND: Total joint replacement (TJR) of the hip or knee for osteoarthritis is among the most common elective surgical procedures. There is some inequity in provision of TJR. How decisions are made about who will have surgery may contribute to disparities in provision. The model of shared decision-making between patients and clinicians is advocated as an ideal by national bodies and guidelines. However, we do not know what happens within orthopaedic practice and whether this reflects the shared model. Our study examined how decisions are made about TJR in orthopaedic consultations. METHODS: The study used a qualitative research design comprising semi-structured interviews and observations. Participants were recruited from three hospital sites and provided their time free of charge. Seven clinicians involved in decision-making about TJR were approached to take part in the study, and six agreed to do so. Seventy-seven patients due to see these clinicians about TJR were approached to take part and 26 agreed to do so. The patients' outpatient appointments ('consultations') were observed and audio-recorded. Subsequent interviews with patients and clinicians examined decisions that were made at the appointments. Data were analysed using thematic analysis. RESULTS: Clinical and lifestyle factors were central components of the decision-making process. In addition, the roles that patients assigned to clinicians were key, as were communication styles. Patients saw clinicians as occupying expert roles and they deferred to clinicians' expertise. There was evidence that patients modified their behaviour within consultations to complement that of clinicians. Clinicians acknowledged the complexity of decision-making and provided descriptions of their own decision-making and communication styles. Patients and clinicians were aware of the use of clinical and lifestyle factors in decision-making and agreed in their description of clinicians' styles. Decisions were usually reached during consultations, but patients and clinicians sometimes said that treatment decisions had been made beforehand. Some patients expressed surprise about the decisions made in their consultations, but this did not necessarily imply dissatisfaction. CONCLUSIONS: The way in which roles and communication are played out in decision-making for TJR may affect the opportunity for shared decisions. This may contribute to variation in the provision of TJR. Making the importance of these factors explicit and highlighting the existence of patients' 'surprise' about consultation outcomes could empower patients within the decision-making process and enhance communication in orthopaedic consultations.