ORCID Profile
0000-0002-4723-5128
Current Organisation
University of Oxford
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Publisher: National Institute for Health and Care Research
Date: 06-2022
DOI: 10.3310/KODQ0769
Abstract: Joint replacement surgery has revolutionised the management of degenerative joint disease. Increasing demand for surgery and post-surgical reviews has overwhelmed orthopaedic services and, consequently, many centres have reduced or stopped follow-up. Such disinvestment is without an evidence base and raises questions regarding the consequences to patients. To produce evidence- and consensus-based recommendations as to how, when and on whom follow-up should be conducted. Our research question was ‘Is it safe to disinvest in mid- to late-term follow-up of hip and knee replacement?’. The study comprised three complementary evidence synthesis work packages to inform a final consensus process. Work package 1 was a systematic review of the clinical effectiveness and cost-effectiveness literature. Work package 2 used routine national data sets (i.e. the Clinical Practice Research Datalink–Hospital Episode Statistics, Hospital Episode Statistics–National Joint Registry–patient-reported outcome measures) to identify pre, peri and postoperative predictors of mid- to late-term revision, and prospective data from 560 patients to understand how patients present for revision surgery. Work package 3 used a Markov model to simulate the survival, health-related quality of life and NHS costs of patients following hip or knee replacement surgery. Finally, evidence from work packages 1–3 informed a face-to-face consensus panel, which involved 32 stakeholders. Our overarching statements are as follows: (1) these recommendations apply to post primary hip and knee replacement follow-up (2) the 10-year time point in these recommendations is based on a lack of robust evidence beyond 10 years and (3) in these recommendations, the term ‘complex cases’ refers to in idual patient and surgical factors that may increase the risk of replacement failure. Our recommendations are as follows: for Orthopaedic Data Evaluation Panel 10A* (ODEP-10A*) minimum implants, it is safe to disinvest in routine follow-up from 1 to 10 years post non-complex hip and knee replacement provided that there is rapid access to orthopaedic review (2) for ODEP-10A* minimum implants in complex cases or non-ODEP-10A* minimum implants, periodic follow-up post hip and knee replacement may be required from 1 to 10 years (3) at 10 years post hip and knee replacement, clinical and radiographic evaluation is recommended and (4) after 10 years post hip and knee replacement, frequency of further follow-up should be based on the 10-year assessment (note that ongoing rapid access to orthopaedic review is still required) [Stone M, Smith L, Kingsbury S, Czoski-Murray C, Judge A, Pinedo-Villanueva R, et al . Evidence-based follow-up recommendations following primary hip and knee arthroplasty (UK SAFE). Orthop Proc 2020 102 – B :13. 0.1302/1358-992X.2020.5.013 ]. The current absence of data beyond 10 years restricted the evidence base. For ODEP-10A* prostheses, the UK SAFE programme demonstrated that it is safe to disinvest in routine follow-up in the 1- to 10-year period after non-complex hip and knee replacement. At 10 years, clinical and radiographic review is recommended. Complex cases, implants not meeting the 10A* criteria and follow-up after revision surgery are not covered by this recommendation. The evidence base for follow-up after 10 years requires further evaluation. Further work should establish the most clinically effective and cost-effective model of delivering a rapid access service and evaluate alternative models for follow-up services, such as virtual clinics. Finally, the needs and outcomes of patients who are symptomatic but do not have appropriate follow-up should be investigated. This study is registered as PROSPERO CRD42017053017. This project was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme and will be published in full in Health and Social Care Delivery Research Vol. 10, No. 16. See the NIHR Journals Library website for further project information.
Publisher: Elsevier BV
Date: 07-2018
Publisher: Springer Science and Business Media LLC
Date: 31-12-2019
DOI: 10.1007/S40519-019-00841-2
Abstract: Approximately 70% of adults in Mexico are overweight or obese. Unhealthy lifestyle behaviors are also prevalent. We examined the association of three lifestyle behaviors with body mass index (BMI) categories in adults from Mexico. We used publicly available data from the ENSANUT 2016 survey ( n = 6419). BMI was used to categorize participants. Differences in sleep duration, suffering from symptoms of insomnia, TV watching time, time in front of any screen, vigorous physical activity (yes vs no), moderate physical activity ( 30 min/day—yes vs. no) and walking ( 60 min/day—yes vs. no) were compared across BMI groups using adjusted linear and logistic regression analyses. Thirty-nine percent of participants were overweight and 37% obese. Time in front of TV, in front of any screen, sleep duration and physical activity were significantly associated with overweight and obesity. Compared to normal weight participants, participants in the obese II category spend on average 0.60 h/day (95% CI 0.36–0.84, p = 0.001) and participants in the obese III category 0.54 h/day (95% CI 0.19–0.89, p 0.001) more in front of any screen participants in the obese II category reported 0.55 h/day less sleep (95% CI − 0.67 to − 0.43, p 0.001) participants in the obese III category were less likely to engage in vigorous activity (OR = 0.60, 95% CI 0.43–0.84, p ≤ 0.003), or walking (OR = 0.65, 95% CI 0.49–0.88, p = 0.005). Screen time, sleeping hours, and physical activity were associated with overweight and obesity. However, these associations were not consistent across all BMI categories. Assuming established causal connections, overweight in iduals and in iduals with obesity would benefit from reduced screen time and engaging in moderate/vigorous physical activity. Level III: observational case-control analytic study.
Publisher: BMJ
Date: 2013
Publisher: British Editorial Society of Bone & Joint Surgery
Date: 03-02-2023
DOI: 10.1302/2633-1462.42.BJO-2022-0149.R1
Abstract: To review the evidence and reach consensus on recommendations for follow-up after total hip and knee arthroplasty. A programme of work was conducted, including: a systematic review of the clinical and cost-effectiveness literature analysis of routine national datasets to identify pre-, peri-, and postoperative predictors of mid-to-late term revision prospective data analyses from 560 patients to understand how patients present for revision surgery qualitative interviews with NHS managers and orthopaedic surgeons and health economic modelling. Finally, a consensus meeting considered all the work and agreed the final recommendations and research areas. The UK poSt Arthroplasty Follow-up rEcommendations (UK SAFE) recommendations apply to post-primary hip and knee arthroplasty follow-up. The ten-year time point is based on a lack of robust evidence beyond ten years. The term 'complex cases' refers to in idual patient and surgical factors that may increase the risk for arthroplasty failure. For Orthopaedic Data Evaluation Panel (ODEP) 10A* minimum implants, it is safe to disinvest in routine follow-up from one to years post-non-complex hip and knee arthroplasty provided there is rapid access to orthopaedic review. For ODEP 10A* minimum implants in complex cases, or non-ODEP 10A* minimum implants, periodic follow-up post-hip and knee arthroplasty may be required from one to ten years. At ten years post-hip and knee arthroplasty, clinical and radiological evaluation is recommended. After ten years post-hip and knee arthroplasty, frequency of further follow-up should be based on the ten-year assessment ongoing rapid access to orthopaedic review is still required. Complex cases, implants not meeting the ODEP 10A* criteria, and follow-up after revision surgery are not covered by this recommendation. Cite this article: Bone Jt Open 2023 (2):72–78.
Publisher: National Institute for Health and Care Research
Date: 11-2021
DOI: 10.3310/HTA25660
Abstract: Although routine NHS data potentially include all patients, confounding limits their use for causal inference. Methods to minimise confounding in observational studies of implantable devices are required to enable the evaluation of patients with severe systemic morbidity who are excluded from many randomised controlled trials. Stage 1 – replicate the Total or Partial Knee Arthroplasty Trial (TOPKAT), a surgical randomised controlled trial comparing unicompartmental knee replacement with total knee replacement using propensity score and instrumental variable methods. Stage 2 – compare the risk benefits and cost-effectiveness of unicompartmental knee replacement with total knee replacement surgery in patients with severe systemic morbidity who would have been ineligible for TOPKAT using the validated methods from stage 1. This was a cohort study. Data were obtained from the National Joint Registry database and linked to hospital inpatient (Hospital Episode Statistics) and patient-reported outcome data. Stage 1 – people undergoing unicompartmental knee replacement surgery or total knee replacement surgery who met the TOPKAT eligibility criteria. Stage 2 – participants with an American Society of Anesthesiologists grade of ≥ 3. The patients were exposed to either unicompartmental knee replacement surgery or total knee replacement surgery. The primary outcome measure was the postoperative Oxford Knee Score. The secondary outcome measures were 90-day postoperative complications (venous thromboembolism, myocardial infarction and prosthetic joint infection) and 5-year revision risk and mortality. The main outcome measures for the health economic analysis were health-related quality of life (EuroQol-5 Dimensions) and NHS hospital costs. In stage 1, propensity score stratification and inverse probability weighting replicated the results of TOPKAT. Propensity score adjustment, propensity score matching and instrumental variables did not. Stage 2 included 2256 unicompartmental knee replacement patients and 57,682 total knee replacement patients who had severe comorbidities, of whom 145 and 23,344 had linked Oxford Knee Scores, respectively. A statistically significant but clinically irrelevant difference favouring unicompartmental knee replacement was observed, with a mean postoperative Oxford Knee Score difference of 2 points using propensity score stratification no significant difference was observed using inverse probability weighting. Unicompartmental knee replacement more than halved the risk of venous thromboembolism [relative risk 0.33 (95% confidence interval 0.15 to 0.74) using propensity score stratification relative risk 0.39 (95% confidence interval 0.16 to 0.96) using inverse probability weighting]. Unicompartmental knee replacement was not associated with myocardial infarction or prosthetic joint infection using either method. In the long term, unicompartmental knee replacement had double the revision risk of total knee replacement [hazard ratio 2.70 (95% confidence interval 2.15 to 3.38) using propensity score stratification hazard ratio 2.60 (95% confidence interval 1.94 to 3.47) using inverse probability weighting], but half of the mortality [hazard ratio 0.52 (95% confidence interval 0.36 to 0.74) using propensity score stratification insignificant effect using inverse probability weighting]. Unicompartmental knee replacement had lower costs and higher quality-adjusted life-year gains than total knee replacement for stage 2 participants. Although some propensity score methods successfully replicated TOPKAT, unresolved confounding may have affected stage 2. Missing Oxford Knee Scores may have led to information bias. Propensity score stratification and inverse probability weighting successfully replicated TOPKAT, implying that some (but not all) propensity score methods can be used to evaluate surgical innovations and implantable medical devices using routine NHS data. Unicompartmental knee replacement was safer and more cost-effective than total knee replacement for patients with severe comorbidity and should be considered the first option for suitable patients. Further research is required to understand the performance of propensity score methods for evaluating surgical innovations and implantable devices. This trial is registered as EUPAS17435. This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment Vol. 25, No. 66. See the NIHR Journals Library website for further project information.
Publisher: BMJ
Date: 03-2022
DOI: 10.1136/BMJOPEN-2021-050877
Abstract: To identify patients at risk of mid-late term revision of hip replacement to inform targeted follow-up. Analysis of linked national data sets from primary and secondary care (Clinical Practice Research Datalink (CPRD-GOLD) National Joint Registry (NJR) English Hospital Episode Statistics (HES) Patient-Reported Outcome Measures (PROMs)). Primary elective total hip replacement (THR) aged≥18. Revision surgery≥5 years (mid-late term) after primary THR. Cox regression modelling to ascertain risk factors of mid-late term revision. HR and 95% CI assessed association of sociodemographic factors, comorbidities, medication, surgical variables and PROMs with mid-late term revision. NJR-HES-PROMs data were available from 2008 to 2011 on 142 275 THR mean age 70.0 years and 61.9% female. CPRD GOLD-HES data covered 1995–2011 on 17 047 THR mean age 68.4 years, 61.8% female. Patients had minimum 5 years postprimary surgery to end 2016. In NJR-HES-PROMS data, there were 3582 (2.5%) revisions, median time-to-revision after primary surgery 1.9 years (range 0.01–8.7), with 598 (0.4%) mid-late term revisions in CPRD GOLD, 982 (5.8%) revisions, median time-to-revision 5.3 years (range 0–20), with 520 (3.1%) mid-late term revisions. Reduced risk of mid-late term revision was associated with older age at primary surgery (HR: 0.96 95% CI: 0.95 to 0.96) better 6-month postoperative pain/function scores (HR: 0.35 95% CI: 0.27 to 0.46) use of ceramic-on-ceramic (HR: 0.73 95% CI: 0.56 to 0.95) or ceramic-on-polyethylene (HR: 0.76 95% CI: 0.58 to 1.00) bearing surfaces. Increased risk of mid-late term revision was associated with the use of antidepressants (HR: 1.32 95% CI: 1.09 to 1.59), glucocorticoid injections (HR: 1.33 95% CI: 1.06 to 1.67) and femoral head size≥44 mm (HR: 2.56 95% CI: 1.09 to 6.02) No association of gender, obesity or Index of Multiple Deprivation was observed. The risk of mid-late term THR is associated with age at primary surgery, 6-month postoperative pain and function and implant factors. Further work is needed to explore the associations with prescription medications observed in our data.
Publisher: Springer Science and Business Media LLC
Date: 08-02-2023
DOI: 10.1186/S12891-023-06190-7
Abstract: Follow-up visits 5 or 7 years after surgery were recommended for people having primary hip or knee replacement. The benefits of this practice to patients and the healthcare system, however, have not yet been specifically examined. The aim of this study was to investigate the association between long-term follow-up outpatient hospital visits and revision rates for patients who undergo primary knee or hip replacement surgery. Cohorts were identified for patients undergoing knee or hip replacement surgery using medical records from primary care practices within the UK Clinical Practice Research Datalink (CPRD) GOLD dataset linked to hospital records from the English Hospital Episodes Statistics (HES) data. Two groups of patients were compared in terms of revision and mortality rates: those with at least one long-term (between five and 10 years since primary surgery) follow-up visit at the orthopaedic department (‘Follow-up’ group), and those without (‘No follow-up’ group). A total of 9856 (4349 in the Follow-up group) patients with knee replacement and 10,837 (4870 in the Follow-up group) with hip replacement were included in the analysis. For knee replacement, the incidence of revision was 3.6% for those followed-up and 0.6% for those not followed-up. An adjusted regression model confirmed the difference in the hazard ratio (HR) for revision was statistically significant (HR: 5.65 [95% CI 3.62 to 8.81]). Mortality at 4 years was lower for the Follow-up (17%) compared to the No follow-up group (21%), but this difference was not statistically significant (HR: 0.95 [0.84 to 1.07]). For hip replacement, the incidence of revision rates were 3.2 and 1.4% for the follow-up and not follow-up groups, respectively, the difference being statistically significant (HR: 2.34 [1.71 to 3.20]). Mortality was lower for the Follow-up (15%) compared to the No follow-up group (21%), but the difference was not statistically significant (HR: 0.91 [0.81 to 1.02]). Patients attending follow-up orthopaedic consultations show a higher risk of revision surgery compared to those who are not followed-up. A cause for this difference could not be identified in this study but a likely explanation is that surgeons play an effective role as ultimate arbitrators when identifying patients to be included in long-term follow-up lists.
Publisher: National Institute for Health and Care Research
Date: 2014
DOI: 10.3310/HTA18060
Abstract: Antibiotics are still prescribed to most patients attending primary care with acute sore throat, despite evidence that there is modest benefit overall from antibiotics. Targeting antibiotics using either clinical scoring methods or rapid antigen detection tests (RADTs) could help. However, there is debate about which groups of streptococci are important (particularly Lancefield groups C and G), and uncertainty about the variables that most clearly predict the presence of streptococci. This study aimed to compare clinical scores or RADTs with delayed antibiotic prescribing. The study comprised a RADT in vitro study two diagnostic cohorts to develop streptococcal scores (score 1 score 2) and, finally, an open pragmatic randomised controlled trial with nested qualitative and cost-effectiveness studies. The setting was UK primary care general practices. Participants were patients aged ≥ 3 years with acute sore throat. An internet program randomised patients to targeted antibiotic use according to (1) delayed antibiotics (control group), (2) clinical score or (3) RADT used according to clinical score. The main outcome measures were self-reported antibiotic use and symptom duration and severity on seven-point Likert scales (primary outcome: mean sore throat/difficulty swallowing score in the first 2–4 days). The IMI TestPack Plus Strep A (Inverness Medical, Bedford, UK) was sensitive, specific and easy to use. Lancefield group A/C/G streptococci were found in 40% of cohort 2 and 34% of cohort 1. A five-point score predicting the presence of A/C/G streptococci [FeverPAIN: Fever Purulence Attend rapidly (≤ 3 days) severe Inflammation and No cough or coryza] had moderate predictive value (bootstrapped estimates of area under receiver operating characteristic curve: 0.73 cohort 1, 0.71 cohort 2) and identified a substantial number of participants at low risk of streptococcal infection. In total, 38% of cohort 1 and 36% of cohort 2 scored ≤ 1 for FeverPAIN, associated with streptococcal percentages of 13% and 18%, respectively. In an adaptive trial design, the preliminary score (score 1 n = 1129) was replaced by FeverPAIN ( n = 631). For score 1, there were no significant differences between groups. For FeverPAIN, symptom severity was documented in 80% of patients, and was lower in the clinical score group than in the delayed prescribing group (–0.33 95% confidence interval –0.64 to –0.02 p = 0.039 equivalent to one in three rating sore throat a slight rather than moderately bad problem), and a similar reduction was observed for the RADT group (–0.30 –0.61 to 0.00 p = 0.053). Moderately bad or worse symptoms resolved significantly faster (30%) in the clinical score group (hazard ratio 1.30 1.03 to 1.63) but not the RADT group (1.11 0.88 to 1.40). In the delayed group, 75/164 (46%) used antibiotics, and 29% fewer used antibiotics in the clinical score group (risk ratio 0.71 0.50 to 0.95 p = 0.018) and 27% fewer in the RADT group (0.73 0.52 to 0.98 p = 0.033). No significant differences in complications or reconsultations were found. The clinical score group dominated both other groups for both the cost/quality-adjusted life-years and cost/change in symptom severity analyses, being both less costly and more effective, and cost-effectiveness acceptability curves indicated the clinical score to be the most likely to be cost-effective from an NHS perspective. Patients were positive about RADTs. Health professionals’ concerns about test validity, the time the test took and medicalising self-limiting illness lessened after using the tests. For both RADTs and clinical scores, there were tensions with established clinical experience. Targeting antibiotics using a clinical score (FeverPAIN) efficiently improves symptoms and reduces antibiotic use. RADTs used in combination with FeverPAIN provide no clear advantages over FeverPAIN alone, and RADTs are unlikely to be incorporated into practice until health professionals’ concerns are met and they have experience of using them. Clinical scores also face barriers related to clinicians’ perceptions of their utility in the face of experience. This study has demonstrated the limitation of using one data set to develop a clinical score. FeverPAIN, derived from two data sets, appears to be valid and its use improves outcomes, but diagnostic studies to confirm the validity of FeverPAIN in other data sets and settings are needed. Experienced clinicians need to identify barriers to the use of clinical scoring methods. Implementation studies that address perceived barriers in the use of FeverPAIN are needed. Current Controlled Trials ISRCTN32027234. This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment Vol. 18, No. 6. See the NIHR Journals Library website for further project information.
Publisher: BMJ
Date: 03-2022
DOI: 10.1136/BMJOPEN-2020-046900
Abstract: To identify patients at risk of mid-late term revision of knee replacement (KR) to inform targeted follow-up. Analysis of linked national datasets from primary and secondary care (Clinical Practice Research Datalink (CPRD GOLD), National Joint Registry (NJR), English Hospital Episode Statistics (HES) and Patient Reported Outcome Measures (PROMs)). Primary elective KRs aged ≥18 years. Revision surgery ≥5 years (mid–late term) postprimary KR. Cox regression modelling to ascertain risk factors of mid–late term revision. HRs and 95% CIs assessed association of sociodemographic factors, comorbidities, medication, surgical variables and PROMs with mid–late term revision. NJR-HES-PROMs data were available from 2008 to 2011 on 188 509 KR. CPRD GOLD-HES data covered 1995–2011 on 17 378 KR. Patients had minimum 5 years postprimary surgery to end 2016. Age and gender distribution were similar across datasets mean age 70 years, 57% female. In NJR, there were 8607 (4.6%) revisions, median time-to-revision postprimary surgery 1.8 years (range 0–8.8), with 1055 (0.6%) mid–late term revisions in CPRD GOLD, 877 (5.1%) revisions, median time-to-revision 4.2 years (range 0.02–18.3), with 352 (2.0%) mid–late term revisions. Reduced risk of revision after 5 years was associated with older age (HR: 0.95 95% CI 0.95 to 0.96), obesity (0.70 0.56 to 0.88), living in deprived areas (0.71 0.58 to 0.87), non-white ethnicity (0.58 0.43 to 0.78), better preoperative pain and functional limitation (0.42 0.33 to 0.53), better 6-month postoperative pain and function (0.33 0.26 to 0.41) or moderate anxiety/depression (0.73 0.63 to 0.83) at primary surgery. Increased risk was associated with male gender (1.32 1.04 to 1.67) when anticonvulsants (gabapentin and pregabalin) (1.58 1.01 to 2.47) or opioids (1.36 1.08 to 1.71) were required prior to primary surgery. No implant factors were identified. The risk of mid–late term KR revision is very low. Increased risk of revision is associated with patient case-mix factors, and there is evidence of sociodemographic inequality.
Publisher: Springer Science and Business Media LLC
Date: 28-09-2022
DOI: 10.1007/S11136-022-03262-4
Abstract: In order to enable cost-utility analysis of shoulder pain conditions and treatments, this study aimed to develop and evaluate mapping algorithms to estimate the EQ-5D health index from the Oxford Shoulder Score (OSS) when health outcomes are only assessed with the OSS. 5437 paired OSS and EQ-5D questionnaire responses from four national multicentre randomised controlled trials investigating different shoulder pathologies and treatments were split into training and testing s les. Separate EQ-5D-3L and EQ-5D-5L analyses were undertaken. Transfer to utility (TTU) regression (univariate linear, polynomial, spline, multivariable linear, two-part logistic-linear, tobit and adjusted limited dependent variable mixture models) and response mapping (ordered logistic regression and seemingly unrelated regression (SUR)) models were developed on the training s le. These were internally validated, and their performance evaluated on the testing s le. Model performance was evaluated over 100-fold repeated training–testing s le splits. For the EQ-5D-3L analysis, the multivariable linear and splines models had the lowest mean square error (MSE) of 0.0415. The SUR model had the lowest mean absolute error (MAE) of 0.136. Model performance was greatest in the mid-range and best health states, and lowest in poor health states. For the EQ-5D-5L analyses, the multivariable linear and splines models had the lowest MSE (0.0241–0.0278) while the SUR models had the lowest MAE (0.105–0.113). The developed models now allow accurate estimation of the EQ-5D health index when only the OSS responses are available as a measure of patient-reported health outcome.
Publisher: National Institute for Health and Care Research
Date: 2021
DOI: 10.3310/HTA25050
Abstract: Chronic pain is a common cause of health-related incapacity for work among people in the UK. In idualised placement and support is a systematic approach to rehabilitation, with emphasis on early supported work placement. It is effective in helping people with severe mental illness to gain employment, but has not been tested for chronic pain. To inform the design of a definitive randomised controlled trial to assess the clinical effectiveness of in idualised placement and support for people unemployed because of chronic pain. A mixed-methods feasibility study comprising qualitative interviews and focus groups with key stakeholders, alongside a pilot trial. Primary care-based health-care professionals, employment support workers, employers, clients who participated in an in idualised placement and support programme, and in iduals aged 18–64 years with chronic pain who were unemployed for at least 3 months. An in idualised placement and support programme integrated with a personalised, responsive pain management plan, backed up by communication with a general practitioner and rapid access to community-based pain services. Outcomes included stakeholder views about a trial and methods of recruitment the feasibility and acceptability of the in idualised placement and support intervention study processes (including methods to recruit participants from primary care, training and support needs of the employment support workers to integrate with pain services, acceptability of randomisation and the treatment-as-usual comparator) and scoping of outcome measures for a definitive trial. All stakeholders viewed a trial as feasible and important, and saw the relevance of employment interventions in this group. Using all suggested methods, recruitment was feasible through primary care, but it was slow and resource intensive. Recruitment through pain services was more efficient. Fifty people with chronic pain were recruited (37 from primary care and 13 from pain services). Randomisation was acceptable, and 22 participants were allocated to in idualised placement and support, and 28 participants were allocated to treatment as usual. Treatment as usual was found acceptable. Retention of treatment-as-usual participants was acceptable throughout the 12 months. However, follow-up of in idualised placement and support recipients using postal questionnaires proved challenging, especially when the participant started paid work, and new approaches would be needed for a trial. Clients, employment support workers, primary care-based health-care professionals and employers contributed to manualisation of the intervention. No adverse events were reported. Unless accurate and up-to-date employment status information can be collected in primary care health records, or linkage can be established with employment records, research such as this relating to employment will be impracticable in primary care. The trial may be possible through pain services however, clients may differ. Retention of participants proved challenging and methods for achieving this would need to be developed. The intervention has been manualised. Current Controlled Trials ISRCTN30094062. This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment Vol. 25, No. 5. See the NIHR Journals Library website for further project information.
Publisher: BMJ
Date: 06-2019
DOI: 10.1136/BMJOPEN-2019-031351
Abstract: Hip and knee arthroplasties have revolutionised the management of degenerative joint diseases and, due to an ageing population, are becoming increasingly common. Follow-up of joint prostheses is to identify problems in symptomatic or asymptomatic patients due to infection, osteolysis, bone loss or potential periprosthetic fracture, enabling timely intervention to prevent catastrophic failure at a later date. Early revision is usually more straight-forward surgically and less traumatic for the patient. However, routine long-term follow-up is costly and requires considerable clinical time. Therefore, some centres in the UK have curtailed this aspect of primary hip and knee arthroplasty services, doing so without an evidence base that such disinvestment is clinically or cost-effective. Given the timeline from joint replacement to revision, conducting a randomised controlled trial (RCT) to determine potential consequences of disinvestment in hip and knee arthroplasty follow-up is not feasible. Furthermore, the low revision rates of modern prostheses, less than 10% at 10 years, would necessitate thousands of patients to adequately power such a study. The huge variation in follow-up practice across the UK also limits the generalisability of an RCT. This study will therefore use a mixed-methods approach to examine the requirements for arthroplasty follow-up and produce evidence-based and consensus-based recommendations as to how, when and on whom follow-up should be conducted. Four interconnected work packages will be completed: (1) a systematic literature review (2a) analysis of routinely collected National Health Service data from five national data sets to understand when and which patients present for revision surgery (2b) prospective data regarding how patients currently present for revision surgery (3) economic modelling to simulate long-term costs and quality-adjusted life years associated with different follow-up care models and (4) a Delphi-consensus process, involving all stakeholders, to develop a policy document which includes a stratification algorithm to determine appropriate follow-up care for an in idual patient. Favourable ethical opinion has been obtained for WP2a (RO-HES) (220520) and WP2B (220316) from the National Research Ethics Committee. Following advice from the Confidentiality Advisory Group (17/CAG/0122), data controllers for the data sets used in WP2a (RO-HES) – NHS Digital and The Phoenix Partnership – confirmed that Section 251 support was not required as no identifiable data was flowing into or out of these parties. Application for approval of WP2a (RO-HES) from the Independent Group Advising on the Release of Data (IGARD) at NHS Digital is in progress (DARS-NIC-147997). Section 251 support (17/CAG/0030) and NHS Digital approval (DARS-NIC-172121-G0Z1H-v0.11) have been obtained for WP2a (NJR-HES-PROMS). ISAC (11_050MnA2R2) approval has been obtained for WP2a (CPRD-HES).
Location: United Kingdom of Great Britain and Northern Ireland
Location: Venezuela (Bolivarian Republic of)
Location: United Kingdom of Great Britain and Northern Ireland
Location: United Kingdom of Great Britain and Northern Ireland
No related grants have been discovered for Rafael Pinedo-Villanueva.