A clinical tool to identify older women with back pain at high risk of osteoporotic vertebral fractures (Vfrac): a population-based cohort study with exploratory economic evaluation.

BACKGROUND: osteoporotic vertebral fractures (OVFs) identify people at high risk of future fractures, but despite this, less than a third come to clinical attention. The objective of this study was to develop a clinical tool to aid health care professionals decide which older women with back pain should have a spinal radiograph. METHODS: a population-based cohort of 1,635 women aged 65+ years with self-reported back pain in the previous 4 months were recruited from primary care. Exposure data were collected through self-completion questionnaires and physical examination, including descriptions of back pain and traditional risk factors for osteoporosis. Outcome was the presence/absence of OVFs on spinal radiographs. Logistic regression models identified independent predictors of OVFs, with the area under the (receiver operating) curve calculated for the final model, and a cut-point was identified. RESULTS: mean age was 73.9 years and 209 (12.8%) had OVFs. The final Vfrac model comprised 15 predictors of OVF, with an AUC of 0.802 (95% CI: 0.764-0.840). Sensitivity was 72.4% and specificity was 72.9%. Vfrac identified 93% of those with more than one OVF and two-thirds of those with one OVF. Performance was enhanced by inclusion of self-reported back pain descriptors, removal of which reduced AUC to 0.742 (95% CI: 0.696-0.788) and sensitivity to 66.5%. Health economic modelling to support a future trial was favourable. CONCLUSIONS: the Vfrac clinical tool appears to be valid and is improved by the addition of self-reported back pain symptoms. The tool now requires testing to establish real-world clinical and cost-effectiveness.

The effect of surgical approach in total knee replacement on outcomes. An analysis of 875,166 elective operations from the National Joint Registry for England, Wales, Northern Ireland and the Isle of Man.

BACKGROUND: Total knee replacement (TKR) is clinically and cost-effective. The surgical approach employed influences the outcome, however there is little generalisable and robust evidence to guide practice. We compared outcomes between the common primary TKR surgical approaches. METHODS: 875,166 primary TKRs captured in the National Joint Registry, linked to hospital inpatient, mortality and patient reported outcome measures (PROMs) data, with up to 15.75 years follow-up were analysed. There were 10 surgical approach groups: medial parapatellar, midvastus, subvastus, lateral parapatellar, 'other' and their minimally invasive versions. Survival methods were used to compare revision rates and 45-day mortality. Groups were compared using Cox proportional hazards regression and Flexible Parametric Survival Modelling (FPM). Confounders included age at surgery, sex, risk group (indications additional to osteoarthritis), American Society of Anesthesiologists grade, TKR fixation, year of primary, body mass index, and for mortality, deprivation and Charlson comorbidity subgroups. PROMs were analysed with regression modelling or non-parametric methods. RESULTS: The conventional midvastus approach was associated with lower revision rates (Hazard Rate Ratio (HRR) 0.80 (95% CI 0.71-0.91) P = 0.001) and the lateral parapatellar with higher revision rates (HRR 1.35 (95% CI 1.12-1.63) P = 0.002) compared to the conventional medial parapatellar approach. Mortality rates were similar between approaches. PROMs showed statistically significant, but not clinically important, differences. CONCLUSIONS: There is little difference in PROMs between the various surgical approaches in TKR with all resulting in good outcomes. However, the conventional midvastus approach (used in 3% of cases) was associated with a 20% reduced risk of revision surgery compared to the most commonly used knee approach (the conventional medial parapatellar: used in 91.9% of cases). This data supports the use of the midvastus approach and thus surgeons should consider utilising this approach more frequently. Minimally invasive approaches did not appear to convey any clinical advantage in this study over conventional approaches for primary TKR.

Patellar resurfacing during primary total knee replacement is associated with a lower risk of revision surgery.

AIMS: Debate remains whether the patella should be resurfaced during total knee replacement (TKR). For non-resurfaced TKRs, we estimated what the revision rate would have been if the patella had been resurfaced, and examined the risk of re-revision following secondary patellar resurfacing. METHODS: A retrospective observational study of the National Joint Registry (NJR) was performed. All primary TKRs for osteoarthritis alone performed between 1 April 2003 and 31 December 2016 were eligible (n = 842,072). Patellar resurfacing during TKR was performed in 36% (n = 305,844). The primary outcome was all-cause revision surgery. Secondary outcomes were the number of excess all-cause revisions associated with using TKRs without (versus with) patellar resurfacing, and the risk of re-revision after secondary patellar resurfacing. RESULTS: The cumulative risk of all-cause revision at ten years was higher (p < 0.001) in primary TKRs without patellar resurfacing (3.54% (95% confidence interval (CI) 3.47 to 3.62)) compared to those with resurfacing (3.00% (95% CI 2.91 to 3.11)). Using flexible parametric survival modelling, we estimated one 'excess' revision per 189 cases performed where the patella was not resurfaced by ten years (equivalent to 2,842 excess revisions in our cohort). The risk of all-cause re-revision following secondary patellar resurfacing was 4.6 times higher than the risk of revision after primary TKR with patellar resurfacing (at five years from secondary patellar resurfacing, 8.8% vs 1.9%). CONCLUSION: Performing TKR without patellar resurfacing was associated with an increased risk of revision. Secondary patellar resurfacing led to a high risk of re-revision. This represents a potential substantial healthcare burden that should be considered when forming treatment guidelines and commissioning services. Cite this article: Bone Joint J 2021;103-B(5):864-871.

Patients Receiving a Primary Unicompartmental Knee Replacement Have a Higher Risk of Revision but a Lower Risk of Mortality Than Predicted Had They Received a Total Knee Replacement: Data From the National Joint Registry for England, Wales, Northern Ireland, and the Isle of Man.

BACKGROUND: To determine unicompartmental (UKR) and total knee replacement (TKR) revision rates, compare UKR revision rates with what they would have been had they received TKR instead, and assess subsequent re-revision and 90-day mortality rates. METHODS: Using National Joint Registry data, we estimated UKR and TKR revision and mortality rates. Flexible parametric survival modeling (FPM) was used to model failure in TKR and make estimates for UKR. Kaplan-Meier estimates were used to compare cumulative re-revision for revised UKRs and TKRs. RESULTS: Ten-year UKR revision rates were 2.5 times higher than expected from TKR, equivalent to 70 excess revisions/1000 cases within 10 years (5861 excess revisions in this cohort). Revision rates were 2.5 times higher for the highest quartile volume UKR surgeons compared to the same quartile for TKR and 3.9 times higher for the lowest quartiles respectively. Re-revision rates of revised TKRs (10 years = 17.5%, 95% confidence interval [CI] 16.4-18.7) were similar to revised UKRs (15.2%, 95% CI 13.4-17.1) and higher than revision rates following primary TKR (3.3%, 95% CI 3.1-3.5). Ninety-day mortality rates were lower after UKR compared with TKR (0.08% vs 0.33%) and lower than predicted had UKR patients received a TKR (0.18%), equivalent to 1 fewer death per 1000 cases. CONCLUSION: UKR revision rates were substantially higher than TKR even when demographics and caseload differences were accounted for; however, fewer deaths occur after UKR. This should be considered when forming treatment guidelines and commissioning services. Re-revision rates were similar between revised UKRs and TKRs, but considerably higher than for primary TKR, therefore UKR cannot be considered an intermediate procedure.

What Change in Body Mass Index Is Required to Improve Cardiovascular Outcomes in Childhood and Adolescent Obesity through Lifestyle Interventions: A Meta-Regression.

Background: Using meta-regression, this article aims at establishing the minimum change in BMI-standard deviation score (SDS) needed to improve lipid profiles and blood pressure in children and adolescents with obesity, to aid future trials and guidelines. Methods: Studies with participants involved in lifestyle interventions, aged 4-19 years, with a diagnosis of obesity according to defined BMI thresholds, were considered for inclusion in a large systematic review. Interventions had to report pre- and post-intervention (or mean change in) BMI-SDS, plus either systolic blood pressure (SBP), high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, and/or triglycerides (TGs). Random-effects meta-regression quantified the relationship between mean change in BMI-SDS and mean change in cardiovascular outcomes. Results: Seventy-one papers reported various cardiovascular measurements and mean change in BMI-SDS. Fifty-four, 59, 46, and 54 studies were analyzed, reporting a change in SBP, HDL, LDL, and TG, respectively. Reduction in mean BMI-SDS was significantly related to improvements in SBP, LDL, TG, and HDL (p < 0.05); BMI-SDS reductions of 1, 1.2, and 0.7 ensured a mean reduction of SBP, LDL, and TG, respectively, although an equivalent value for HDL improvement was indeterminate. Conclusion: Reductions in mean BMI-SDS of >1, >1.2, or >0.7 are likely to reduce SBP, LDL, and TG, respectively. Further studies are needed to clarify the optimal duration, intensity, and setting for interventions. Consistency is required regarding derived BMI values to facilitate future systematic reviews and meta-analyses.

The effect of surgical approach in total hip replacement on outcomes: an analysis of 723,904 elective operations from the National Joint Registry for England, Wales, Northern Ireland and the Isle of Man.

BACKGROUND: Total hip replacement (THR) is clinically and cost-effective. The surgical approach employed influences the outcome; however, there is little generalisable and robust evidence to guide practice. METHODS: A total of 723,904 primary THRs captured in the National Joint Registry, linked to hospital inpatient, mortality and patient-reported outcome measures (PROMs) data with up to 13.75 years follow-up, were analysed. There were seven surgical approach groups: conventional posterior, lateral, anterior and trans-trochanteric groups and minimally invasive posterior, lateral and anterior. Survival methods were used to compare revision rates and 90-day mortality. Groups were compared using Cox proportional hazards and Flexible Parametric Survival Modelling (FPM). Confounders included age at surgery, sex, risk group (indications additional to osteoarthritis), American Society of Anesthesiologists grade, THR fixation, thromboprophylaxis, anaesthetic, body mass index (BMI) and deprivation. PROMs were analysed with regression modelling or non-parametric methods. RESULTS: Unadjusted analysis showed a higher revision risk than the referent conventional posterior for the conventional lateral, minimally invasive lateral, minimally invasive anterior and trans-trochanteric groups. This persisted with all adjusted FPM and adjusted Cox models, except in the Cox model including BMI where the higher revision rate only persisted for the conventional lateral approach (hazard rate ratio (HRR) 1.12 [95% CI 1.06,1.17] P < 0·001) and trans-trochanteric approaches (HRR 1.48 [95% CI 1.14,1.91] P = 0.003). PROMs demonstrated statistically, but not clinically, significant differences. Self-reported complications were more frequent with the conventional lateral approach, and the risk of 90-day mortality was higher (HRR 1.15 [95%CI 1.01-1.30] P = 0.029). CONCLUSIONS: Lateral approaches for THR are associated with worse outcomes, including more deaths and revisions, than the posterior approach. We recommend the posterior approach should be considered the current standard approach for THR. Large well-designed studies are needed to assess any potential benefits from using minimally invasive posterior approaches and the conventional anterior approach.

Change in obesity-related metabolic abnormalities associated with body mass index improvement through life-style intervention: A meta-regression.

The reduction in body mass index standard deviation score (BMI-SDS) associated with improvement in biomarkers relating to metabolic health in obese children is unknown. We aimed to establish the change in BMI-SDS associated with improved inflammation, liver function, and insulin resistance to inform clinical guidelines for pediatric weight management interventions and to assess the efficacy of future trials. A large-scale systematic review was conducted to identify relevant studies. Studies of children with a diagnosis of obesity according to defined BMI thresholds, participating in lifestyle interventions to reduce obesity, were included. Studies must have reported baseline (pre-) and postintervention (or change of) BMI-SDS and either fasting glucose, homeostatic model of insulin resistance (HOMA-IR), alanine aminotransferase (ALT), C-reactive protein (CRP), or interleukin-6 (IL-6). A series of meta-regressions were conducted to establish links between BMI-SDS change scores and change in metabolic markers of health. Sixty-eight articles were identified. From the meta-regression analyses, across all study subsets, greater mean falls in all four parameters, (HOMA-IR, Glucose, ALT, and CRP) were observed with greater mean loss of BMI-SDS, but the trends were only statistically significant for HOMA-IR and CRP (P = .003; P = .021). However, we could not find minimum changes in BMI-SDS that would ensure a fall in these outcomes. At this time, we are unable to recommend a definitive value of BMI-SDS reduction needed to improve the markers of metabolic health. Future trials should aim to report additional indices of derived BMI values, which may better reflect changes in actual adiposity.

What change in body mass index is associated with improvement in percentage body fat in childhood obesity? A meta-regression.

OBJECTIVE: Using meta-regression this paper sets out the minimum change in body mass index-SD score (BMI-SDS) required to improve adiposity as percentage body fat for children and adolescents with obesity. DESIGN: Meta-regression. SETTING: Studies were identified as part of a large-scale systematic review of the following electronic databases: AMED, Embase, MEDLINE via OVID, Web of Science and CENTRAL via Cochrane library. PARTICIPANTS: Individuals aged 4-19 years with a diagnosis of obesity according to defined BMI thresholds. INTERVENTIONS: Studies of lifestyle treatment interventions that included dietary, physical activity and/or behavioural components with the objective of reducing obesity were included. Interventions of <2 weeks duration and those that involved surgical and/or pharmacological components (eg, bariatric surgery, drug therapy) were excluded. PRIMARY AND SECONDARY OUTCOME MEASURES: To be included in the review, studies had to report baseline and post-intervention BMI-SDS or change measurements (primary outcome measures) plus one or more of the following markers of metabolic health (secondary outcome measures): adiposity measures other than BMI; blood pressure; glucose; inflammation; insulin sensitivity/resistance; lipid profile; liver function. This paper focuses on adiposity measures only. Further papers in this series will report on other outcome measures. RESULTS: This paper explores the potential impact of BMI-SDS reduction in terms of change in percentage body fat. Thirty-nine studies reporting change in mean percentage body fat were analysed. Meta-regression demonstrated that reduction of at least 0.6 in mean BMI-SDS ensured a mean reduction of percentage body fat mass, in the sense that the associated 95% prediction interval for change in mean percentage body fat was wholly negative. CONCLUSIONS: Interventions demonstrating reductions of 0.6 BMI-SDS might be termed successful in reducing adiposity, a key purpose of weight management interventions. TRIAL REGISTRATION NUMBER: CRD42016025317.

Choice of Prosthetic Implant Combinations in Total Hip Replacement: Cost-Effectiveness Analysis Using UK and Swedish Hip Joint Registries Data.

BACKGROUND: Prosthetic implants used in total hip replacements (THR) have a range of bearing surface combinations (metal-on-polyethylene, ceramic-on-polyethylene, ceramic-on-ceramic, and metal-on-metal), head sizes (small [<36 mm in diameter] and large [≥36 mm in diameter]), and fixation techniques (cemented, uncemented, hybrid, and reverse hybrid). These can influence prosthesis survival, patients' quality of life, and healthcare costs. OBJECTIVES: To compare the lifetime cost-effectiveness of implants for patients of different age and sex profiles. METHODS: We developed a Markov model to compare the cost-effectiveness of various implants against small-head cemented metal-on-polyethylene implants. The probability that patients required 1 or more revision surgeries was estimated from analyses of more than 1 million patients in the UK and Swedish hip joint registries, for men and women younger than 55, 55 to 64, 65 to 74, 75 to 84, and 85 years and older. Implant and healthcare costs were estimated from local procurement prices, national tariffs, and the literature. Quality-adjusted life-years were calculated using published utility estimates for patients undergoing THR in the United Kingdom. RESULTS: Small-head cemented metal-on-polyethylene implants were the most cost-effective for men and women older than 65 years. These findings were robust to sensitivity analyses. Small-head cemented ceramic-on-polyethylene implants were most cost-effective in men and women younger than 65 years, but these results were more uncertain. CONCLUSIONS: The older the patient group, the more likely that the cheapest implants, small-head cemented metal-on-polyethylene implants, were cost-effective. We found no evidence that uncemented, hybrid, or reverse hybrid implants were the most cost-effective option for any patient group. Our findings can influence clinical practice and procurement decisions for healthcare payers worldwide.

The Association of Body Mass Index with Risk of Long-Term Revision and 90-Day Mortality Following Primary Total Hip Replacement: Findings from the National Joint Registry for England, Wales, Northern Ireland and the Isle of Man.

BACKGROUND: The influence of obesity on outcomes following total hip replacement is unclear. Restriction of total hip replacement on the basis of body mass index (BMI) has been suggested. The purpose of this study was to assess the influence of BMI on the risk of revision and 90-day mortality. METHODS: This was a population-based, longitudinal cohort study of the National Joint Registry (NJR) for England, Wales, Northern Ireland and the Isle of Man. Using data recorded from April 2003 to December 2015, linked to Office for National Statistics data, we ascertained revision and 90-day mortality rates following primary total hip replacement by BMI category. The probability of revision was estimated using Kaplan-Meier methods. Associations of BMI with revision and mortality were explored using adjusted Cox proportional hazards regression models. RESULTS: We investigated revision and 90-day mortality among 415,598 and 413,741 primary total hip replacements, respectively. Each data set accounts for approximately 52% of the total number of recorded operations in the NJR. Thirty-eight percent of the patients were classified as obese. At 10 years, class-III obese patients had the highest cumulative probability of revision (6.7% [95% confidence interval (CI), 5.5% to 8.2%]), twice that of the underweight group (3.3% [95% CI, 2.2% to 4.9%]). When the analysis was adjusted for age, sex, American Society of Anesthesiologists [ASA] grade, year of operation, indication, and fixation type, compared with patients with normal BMI, significantly elevated hazard ratios (HRs) for revision were observed for patients in the BMI categories of class-I obese (≥30 to <35 kg/m) (HR, 1.14 [95% CI, 1.07 to 1.22]), class-II obese (≥35 to <40 kg/m) (HR, 1.30 [95% CI, 1.19 to 1.40]), and class-III obese (≥40 to ≤60 kg/m) (HR, 1.43 [95% CI, 1.27 to 1.61]) (p < 0.0005 for all). Underweight patients had a substantially higher cumulative probability of 90-day mortality (1.17%; 95% CI, 0.86% to 1.58%) compared with patients with normal BMI (0.43%; 95% CI, 0.39% to 0.48%). The risk of 90-day mortality was significantly higher for the underweight group (HR, 2.09 [95% CI, 1.51 to 2.89]; p < 0.0005) and significantly lower for patients who were categorized as overweight (HR, 0.70; 95% CI, 0.61 to 0.81; p < 0.0005), class-I obese (HR, 0.69 [95% CI, 0.59 to 0.81]; p < 0.0005), and class-II obese (HR, 0.79 [95% CI, 0.63 to 0.98]; p = 0.049) compared with patients with normal BMI. CONCLUSIONS: Although long-term revision rates following total hip replacement were higher among obese patients, we believe that the rates remained acceptable by contemporary standards and were balanced by a lower risk of 90-day mortality. LEVEL OF EVIDENCE: Prognostic Level III. See Instructions for Authors for a complete description of levels of evidence.

Using long term mortality to determine which perioperative risk factors of mortality following hip and knee replacement may be causal.

Observational studies have identified surgical factors that are associated with a reduced risk of mortality after joint replacement. It is not clear whether these are causal or reflect patient selection. Data on the first primary hip (n = 424,156) and knee replacements (n = 469,989) performed for osteoarthritis in the National Joint Registry were analysed. Flexible parametric survival modelling was used to determine if risk factors for mortality in the perioperative period persisted. To explore selection bias, standardised mortality ratios were calculated for all-cause, respiratory and smoking related cancer mortality using population rates. Selection was apparent for hip resurfacing, combined spinal and general anaesthetic and unicondylar knee implants; reduced mortality was observed for many years for both all and other causes of mortality with a waning effect. Mechanical thromboprophylaxis was also suggestive of selection although patients receiving aspirin had sustained reduced mortality, possibly due to to a cardioprotective effect. Posterior approach for hips was ambiguous with a possible causal component. Spinal anaesthesia was suggestive of a causal effect. We are reliant on observational data when it is not feasible to undertake randomised trials. Our approach of looking at long term mortality risks for perioperative interventions provides further insights to differentiate causal interventions from selection. We recommend the use of aspirin chemothromboprophylaxis, the posterior approach and spinal anaesthetic in total hip replacement due to the apparent causal effect on reduced mortality.

The risk of developing cancer following metal-on-metal hip replacement compared with non metal-on-metal hip bearings: Findings from a prospective national registry "The National Joint Registry of England, Wales, Northern Ireland and the Isle of Man".

BACKGROUND AND PURPOSE: Over 1 million metal-on-metal hip replacements were implanted. Even well-functioning implants produce wear debris that can cause tissue damage, disseminate and cause DNA damage. We aimed to establish if there was an association between metal-on-metal hip replacement and the risk of subsequently developing cancer compared with alternative hip replacements. METHODS: We performed a population based prospective longitudinal cohort study using data from the National Joint Registry linked to Hospital Episode Statistics (n = 403,881 patients). We examined the incidence of a new diagnosis of cancer in patients who received a metal-on-metal bearing in comparison with those who received a non metal-on-metal bearing. Kaplan-Meier estimates of time to first cancer diagnosis were used with Cox proportional hazards regression models to assess the effect on the time to cancer diagnosis for all cancer types, haematological, malignant melanoma, urinary tract cancers or prostate cancer in men. RESULTS: The maximum follow up available was 11.8 years with 25% of patients followed up for more than 6.8 years (mean follow up 4.6 years; median 4.3; IQR 2.1-6.8; range 0.01-11.8). Analyses by gender that adjusted for age at primary and presence or absence of linked Welsh (PEDW) records showed no increase in the risk of developing cancer according to the bearing surface implanted for all cancers, haematological cancers, malignant melanoma, urinary tract cancers or prostate cancer in men. For patients receiving a second hip replacement, there was also no difference. CONCLUSION: We have demonstrated that there is currently no evidence of an increase in the risk of cancer following primary hip replacement according to the type of bearing material used. Although the risk of revision in metal-on-metal bearing hip replacements is higher, it is reassuring that the risk of a new diagnosis of cancer is not currently increased. Despite the long term follow up available in this study, the latency period for some cancers is very long and therefore continued monitoring is required to ensure no new patterns emerge that may indicate need for universal screening.

Implications of Introducing New Technology: Comparative Survivorship Modeling of Metal-on-Metal Hip Replacements and Contemporary Alternatives in the National Joint Registry.

BACKGROUND: New medical technologies are often used widely without adequate supporting data, a practice that can lead to widespread catastrophic failure such as occurred with metal-on-metal (MoM) hip replacements. We determined both how revision rates would have differed if, instead of receiving MoM hip replacements, patients had received existing alternatives and the subsequent cumulative re-revision rates of the patients who did receive MoM hip replacements compared with alternatives. METHODS: This study is a population-based longitudinal cohort study of patient data recorded in the National Joint Registry (NJR) for England, Wales and Northern Ireland between April 2003 and December 2014. We ascertained implant failure rates separately among stemmed MoM total hip replacement (THR) and hip-resurfacing procedures and, using flexible parametric survival modeling, compared them with the failure rates that would have been expected had existing alternatives been used. We used Kaplan-Meier survivorship analysis to compare cumulative re-revision of patients who received stemmed MoM primary replacements that failed and of those who underwent hip resurfacing that failed with those whose non-MoM THRs had failed. RESULTS: In all, 37,555 patients underwent MoM hip resurfacing, with a 10-year revision rate of 12.6% (95% confidence interval [CI]: 12.2% to 13.1%) compared with a predicted revision rate of 4.8% if alternative implants had been used. The 32,024 stemmed MoM THRs had a 19.8% (95% CI: 18.9% to 20.8%) 10-year failure rate compared with an expected rate of 3.9% if alternatives had been used. For every 100 MoM hip-resurfacing procedures, there were 7.8 excess revisions by 10 years, and for every 100 stemmed MoM THR procedures, there were 15.9, which equates to 8,021 excess first revisions. Seven-year re-revision rates were 14.9% (95% CI: 13.8% to 16.2%) for stemmed non-MoM THRs, 18.0% (95% CI: 15.7% to 20.7%) for MoM hip resurfacing, and 19.8% (95% CI: 17.0% to 23.0%) for stemmed MoM THRs. CONCLUSIONS: This study highlights the consequences of widespread and poorly monitored adoption of a medical technology. Over 1 million MoM hip prostheses were implanted worldwide. The excess failure on a global scale will be enormous. This practice of adopting new technologies without adequate supporting data must not be repeated. LEVEL OF EVIDENCE: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

Cognitive behavioural therapy stabilises glycaemic control in adolescents with type 1 diabetes-Outcomes from a randomised control trial.

BACKGROUND: To compare the impact of cognitive behavioural therapy (CBT) with non-directive supportive counselling (NDC) on glycaemic control and psychological well-being in adolescents with type 1 diabetes mellitus (T1DM). MATERIALS AND METHODS: Participants aged 11 to 16 years with T1DM (duration ≥1 year) from 4 UK-based paediatric diabetes centres were randomised to receive either 6 weekly sessions of 1-to-1 CBT (n = 43) or NDC (n = 42), with 2 further sessions at 6 and 12 months. Follow-up continued for 12 months postintervention. Outcome measures included glycated haemoglobin A1c (HbA1c) and psychological scores. RESULTS: The HbA1c levels were available in 33 patients in each group for analysis. Between group difference of the overall changes in HbA1c across the study period was statically significant (P = .018). Geometric mean (range) HbA1c in the NDC group deteriorated from 68 (46-113) to 78 (48-128) mmol/mol (ie, 8.4 [6.4-12.5]% to 9.3 [6.5-13.9]%; P = .001), but was maintained in the CBT group from 72 (46-129) to 73 (51-128) mmol/mol (P = .51) (ie, 8.7 [6.4-14]% to 8.9 [6.8-13.9]%). More patients who have undergone CBT showed an improved or maintained HbA1c levels at 24 months (62.5% vs 35.5%, P = .032). Patients offered CBT with depressive scores in the lowest tertile (least depressive symptoms) showed improvement in HbA1c over time from 70 (46-102) to 67 (57-87) mmol/mol (P = .041) (ie, 8.6 [6.4-11.5]% to 8.3 [7.4-10.1]%), but not in the NDC group. The CBT showed borderline improvements in Children's Health Locus of Control (internal) scores over time compared with NDC (P = .05). The self-efficacy score showed significant improvement in both CBT (P < .001) and NDC (P = .03) groups over time. CONCLUSIONS: CBT demonstrated better maintenance of glycaemic control compared with NDC.

Choice of implant combinations in total hip replacement: systematic review and network meta-analysis.

Objective To compare the survival of different implant combinations for primary total hip replacement (THR). Design Systematic review and network meta-analysis. Data sources Medline, Embase, The Cochrane Library, ClinicalTrials.gov, WHO International Clinical Trials Registry Platform, and the EU Clinical Trials Register.Review methods Published randomised controlled trials comparing different implant combinations. Implant combinations were defined by bearing surface materials (metal-on-polyethylene, ceramic-on-polyethylene, ceramic-on-ceramic, or metal-on-metal), head size (large ≥36 mm or small <36 mm), and fixation technique (cemented, uncemented, hybrid, or reverse hybrid). Our reference implant combination was metal-on-polyethylene (not highly cross linked), small head, and cemented. The primary outcome was revision surgery at 0-2 years and 2-10 years after primary THR. The secondary outcome was the Harris hip score reported by clinicians.Results 77 studies were included in the systematic review, and 15 studies (3177 hips) in the network meta-analysis for revision. There was no evidence that the risk of revision surgery was reduced by other implant combinations compared with the reference implant combination. Although estimates are imprecise, metal-on-metal, small head, cemented implants (hazard ratio 4.4, 95% credible interval 1.6 to 16.6) and resurfacing (12.1, 2.1 to 120.3) increase the risk of revision at 0-2 years after primary THR compared with the reference implant combination. Similar results were observed for the 2-10 years period. 31 studies (2888 patients) were included in the analysis of Harris hip score. No implant combination had a better score than the reference implant combination.Conclusions Newer implant combinations were not found to be better than the reference implant combination (metal-on-polyethylene (not highly cross linked), small head, cemented) in terms of risk of revision surgery or Harris hip score. Metal-on-metal, small head, cemented implants and resurfacing increased the risk of revision surgery compared with the reference implant combination. The results were consistent with observational evidence and were replicated in sensitivity analysis but were limited by poor reporting across studies.Systematic review registration PROSPERO CRD42015019435.

The Main Cause of Death Following Primary Total Hip and Knee Replacement for Osteoarthritis: A Cohort Study of 26,766 Deaths Following 332,734 Hip Replacements and 29,802 Deaths Following 384,291 Knee Replacements.

BACKGROUND: Patients undergoing primary total joint replacement are selected for surgery and thus (other than having a transiently increased mortality rate postoperatively) have a lower mortality rate than age and sex-matched individuals do. Understanding the causes of death following joint replacement would allow targeted strategies to reduce the risk of death and optimize outcome. We aimed to determine the rates and causes of mortality for patients undergoing primary total hip or knee replacement compared with individuals in the general population who were matched for age and sex. METHODS: We compared causes and rates of mortality between age and sex-matched individuals in the general population (National Joint Registry for England, Wales and Northern Ireland; Hospital Episode Statistics; and Office for National Statistics) and a linked cohort of 332,734 patients managed with total hip replacement (26,766 of whom died before the censoring date) and 384,291 patients managed with primary total knee replacement (29,802 of whom died before the censoring date) from 2003 through 2012. RESULTS: The main causes of death were malignant neoplasms (33.8% [9,037] of 26,766 deaths in patients with total hip replacement and 33.3% [9,917] of 29,802 deaths in patients with total knee replacement), circulatory system disorders (32.8% [8,784] of the deaths in patients with total hip replacement and 33.3% [9,932] of the deaths in patients with total knee replacement), respiratory system disorders (10.9% [2,928] of the deaths in patients with total hip replacement and 9.8% [2,932] of the deaths in patients with total knee replacement), and digestive system diseases (5.5% [1,465] of the deaths in patients with total hip replacement and 5.3% [1,572] of the deaths in patients with total knee replacement). There was a relative reduction in mortality (39%) compared with the individuals in the general population that equalized to the rate in the general population by 7 years for hips (overall standardized mortality ratio [SMR], 0.61; 95% confidence interval [CI], 0.60 to 0.62); for knees, the relative reduction (43%) partially attenuated by 7 years but still had not equalized to the rate in the general population (overall SMR, 0.57; 95% CI, 0.56 to 0.57). Ischemic heart disease was the most common cause of death within 90 days (29% [431] of the deaths in patients with primary hip replacement and 31% [436] of the deaths in patients with primary knee replacement). There was an elevated risk of death from circulatory, respiratory, and (most markedly) digestive system-related causes within 90 days postoperatively compared with 91 days to 1 year postoperatively. CONCLUSIONS: Ischemic heart disease is the leading cause of death in the 90 days following total joint replacement, and there is an increase in postoperative deaths associated with digestive system-related disease following joint replacement. Interventions targeted at reducing these diseases may have the largest effect on mortality in total joint replacement patients. LEVEL OF EVIDENCE: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

Incidence and Clinical Associations of Childhood Acute Pancreatitis.

OBJECTIVES: To establish the UK incidence and clinical associations of acute pancreatitis (AP) in children aged 0 to 14 years. METHODS: Monthly surveillance of new cases of AP in children under 15 years of age through the British Pediatric Surveillance Unit conducted from April 2013 to April 2014 (inclusive) followed by 1-year administrative follow-up for all valid cases. RESULTS: Ninety-four cases (48 boys) fulfilled the diagnostic criteria. The median age at diagnosis was 11.2 years (range 1.3-14.9). White children accounted for 61% of the cases compared with 28% from Asian and 5% from African ethnicities. Pakistani children accounted for 18 of 26 (69%) Asian patients and 19% of the total cohort. The incidence of AP in children in the United Kingdom was 0.78 per 100 000/year (95% confidence interval [CI] 0.62-0.96). The incidence in Pakistani children (4.55; 95% CI 2.60-7.39) was sevenfold greater than white children (0.63; 95% CI 0.47-0.83). Of the 94 cases, 35 (37%) were idiopathic; other associations were: drug therapy, 18 (19%); gallstones, 12 (13%); hereditary, 7 (7%); organic acidemias, 7 (7%); anatomic anomalies, 5 (5%); viral infections, 3 (3%); systemic diseases, 2 (2%); and trauma 1 (1%). The most common drug associations were asparaginase (28%), azathioprine (17%), and sodium valproate (17%). CONCLUSIONS: Although still relatively uncommon in the United Kingdom, on average there is >1 case of childhood AP diagnosed every week. The associations of AP have changed significantly since the 1970-80s. Overrepresentation of Pakistani children is worthy of further investigation.

The choice between hip prosthetic bearing surfaces in total hip replacement: a protocol for a systematic review and network meta-analysis.

BACKGROUND: Prosthetic hip implants have many combinations of bearing surface materials, sizes, and fixation techniques, which can determine the quality of life of patients after primary total hip replacement (THR) and the likelihood of needing revision surgery. When an implant fails, patients require revision THR, which is distressing to the patient and expensive for the health care payer. Primary THR is one of the most common elective procedures performed worldwide, with over 300,000 performed annually in the USA and over 80,000 in England and Wales. It is important to review all available randomised controlled trial (RCT) evidence to determine which implant bearing surface materials, size, and fixation technique are most effective for patients. METHODS/DESIGN: This is a protocol for a systematic review and meta-analysis of RCTs comparing outcomes of hip implant bearing surfaces, size, and fixation techniques used in THR. Implant combinations compared in the literature include four bearing surface combinations (metal-on-polyethylene, metal-on-metal, ceramic-on-polyethylene, and ceramic-on-ceramic); two femoral head sizes (large vs small heads); and four fixation techniques (uncemented, cemented, hybrid, and reverse hybrids). The primary outcome will be revision surgery. We will also collect data on patient characteristics, mortality, quality of life, and other outcomes. In network meta-analysis, we will estimate the relative effectiveness of every implant bearing surface, head size (large vs small), and fixation permutation, using evidence where implants have been compared directly in an RCT and indirectly through common comparators in different RCTs. DISCUSSION: There has been much debate about materials used for prosthetic implants in THR. Different combinations of prosthetic materials, sizes, and fixation, can vary widely in cost and fail at different rates for different patient groups. Given the number of THRs performed yearly, and the increasing use of expensive implants, it is important to review evidence to inform surgeons, patients, and health care providers of optimal implant bearing combinations for given patient characteristics. This review will inform a cost-effectiveness model that will include evidence from other sources, to determine the most effective and cost-effective implant bearing combination for patients. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42015019435.

Good outcome of total hip replacement in patients with cerebral palsy: A comparison of 389 patients and 425,813 controls from the National Joint Registry for England and Wales.

BACKGROUND AND PURPOSE: People with cerebral palsy (CP) often have painful deformed hips, but they are seldom treated with hip replacement as the surgery is considered to be high risk. However, few data are available on the outcome of hip replacement in these patients. PATIENTS AND METHODS: We linked Hospital Episode Statistics (HES) records to the National Joint Registry for England and Wales to identify 389 patients with CP who had undergone hip replacement. Their treatment and outcomes were compared with those of 425,813 patients who did not have CP. Kaplan-Meier estimates were calculated to describe implant survivorship and the curves were compared using log-rank tests, with further stratification for age and implant type. Reasons for revision were quantified as patient-time incidence rates (PTIRs). Nationally collected patient-reported outcomes (PROMS) before and 6 months after operation were compared if available. Cumulative mortality (Kaplan-Meier) was estimated at 90 days and at 1, 3, and 5 years. RESULTS: The cumulative probability of revision at 5 years post-surgery was 6.4% (95% CI: 3.8-11) in the CP cohort as opposed to 2.9% (CI 2.9-3%) in the non-CP cohort (p < 0.001). Patient-reported outcomes showed that CP patients had worse pain and function preoperatively, but had equivalent postoperative improvement. The median improvement in Oxford hip score at 6 months was 23 (IQR: 14-28) in CP and it was 21 (14-28) in non-CP patients. 91% of CP patients reported good or excellent satisfaction with their outcome. The cumulative probability of mortality for CP up to 7 years was similar to that in the controls after stratification for age and sex. INTERPRETATION: Hip replacement for cerebral palsy appears to be safe and effective, although implant revision rates are higher than those in patients without cerebral palsy.

Mixing of components from different manufacturers in total hip arthroplasty: prevalence and comparative outcomes.

BACKGROUND AND PURPOSE: There have recently been highly publicized examples of suboptimal outcomes with some newer implant designs used for total hip replacement. This has led to calls for tighter regulation. However, surgeons do not always adhere to the regulations already in place and often use implants from different manufacturers together to replace a hip, which is against the recommendations of the Medicines and Healthcare Products Regulatory Agency (MHRA) and the directions of the manufacturers. PATIENTS AND METHODS: We used data from the National Joint Registry of England and Wales (NJR) to investigate this practice. RESULTS: Mixing of components was common, and we identified over 90,000 cases recorded between 2003 and 2013. In the majority of these cases (48,156), stems and heads from one manufacturer were mixed with polyethylene cemented cups from another manufacturer. When using a cemented stem and a polyethylene cup, mixing of stems from one manufacturer with cups from another was associated with a lower revision rate. At 8 years, the cumulative percentage of revisions was 1.9% (95% CI: 1.7-2.1) in the mixed group as compared to 2.4% (2.3-2.5) in the matched group (p = 0.001). Mixing of heads from one manufacturer with stems from another was associated with a higher revision rate (p < 0.001). In hip replacements with ceramic-on-ceramic or metal-on-metal bearings, mixing of stems, heads, and cups from different manufacturers was associated with similar revision rates (p > 0.05). INTERPRETATION: Mixing of components from different manufacturers is a common practice, despite the fact that it goes against regulatory guidance. However, it is not associated with increased revision rates unless heads and stems from different manufacturers are used together.