Risk of conversion to total knee arthroplasty after surgically treated tibial plateau fractures: an observational cohort study of 439 patients.

BACKGROUND AND PURPOSE: We aimed to assess joint failure rate, i.e., subsequent conversion to TKA after surgical treatment of a tibial plateau fracture (TPF). Secondary aims were to explore the association between joint failure and fracture type, and to determine the risk of failure associated with inadequate joint surface reduction. METHODS: We included all patients ≥ 18 years of age with a surgically treated TPF, treated at Uppsala University Hospital between 2002 and 2015. All fractures were classified according to the Arbeitsgemeinschaft für Osteosynthesefragen/Orthopaedic Traumatology Association (AO/OTA) classification. Postoperative radiographs were evaluated to determine the quality of joint surface inadequate reduction, defined as an articular step-off ≥ 2 mm. The study cohort was linked with the Swedish Arthroplasty Register (SAR) for information on subsequent total knee arthroplasty (TKA). RESULTS: 439 patients (57% women) with a mean age of 55 years (SD 17) were included. According to the AO/OTA classification, the fracture distribution was B1: 4.8%, B2: 10%, B3: 47%, C1: 12%, C2: 6.4%, and C3: 19%. 23 patients (5.2%) were converted to a TKA within 2 years of initial surgery, and 34 patients (7.7%) had been converted by the end of follow-up (16 years). AO/OTA type B3 and C3 had a 6.8 (95% confidence interval [CI] 1.6-29) times greater risk of joint failure compared with B1-2 and C1-C2 at 2 years' follow-up. Inadequate joint surface reduction led to an 8.4 (CI 3.6-20) times greater risk of conversion to TKA at 2 years' follow-up. CONCLUSION: Overall, 5.2% were converted to a TKA within 2 years. Fracture types AO/OTA B3 and C3 with a comminuted articular surface and inadequate joint surface reduction were strongly associated with joint failure.

Patient-surgeon sex discordance impacts adverse events but does not affect patient-reported satisfaction after primary total hip arthroplasty: a regional register-based cohort study.

BACKGROUND AND PURPOSE: The sex of the surgeon has been proposed to be associated with a disparity in clinical outcomes after different surgical procedures. We investigated the association between surgeon-patient sex discordance and adverse events (AEs) and surgical AEs (SAEs) within 90 days after primary total hip arthroplasty (THA). We also investigated patient-reported satisfaction with surgical outcomes 1 year after the surgery. PATIENTS AND METHODS: We conducted a register-based cohort study including primary THAs performed due to osteoarthritis between 2008 and 2016 at 10 publicly managed hospitals in western Sweden. Hospital data was linked to the Swedish Arthroplasty Register and a regional patient register. Logistic regression models investigated discordant sex of patients and surgeons on AEs/SAEs and patient-reported satisfaction with the surgical outcome. RESULTS: 11,993 primary THAs were included in the study. The proportion of AEs for the concordant group was 7.3% and for the discordant group 6.1%. For SAEs, the proportion was 5.0% for the concordant group and 4.3% for the discordant group. After adjustment the discordant group still had a lower likelihood of an AE or SAE than the concordant group: adjusted odds ratio (aOR) for AE (0.82, 95%CI 0.71-0.95) and for SAE (0.86, CI 0.72-0.99). No association was detected between patient-reported satisfaction and sex discordance. CONCLUSION: Sex discordance between surgeons and patients is linked to a decreased risk of an AE but not a lower level of patient-reported satisfaction with the surgical outcome.

Prediction of 90-day mortality after total hip arthroplasty.

AIMS: To develop and externally validate a parsimonious statistical prediction model of 90-day mortality after elective total hip arthroplasty (THA), and to provide a web calculator for clinical usage. METHODS: We included 53,099 patients with cemented THA due to osteoarthritis from the Swedish Hip Arthroplasty Registry for model derivation and internal validation, as well as 125,428 patients from England and Wales recorded in the National Joint Register for England, Wales, Northern Ireland, the Isle of Man, and the States of Guernsey (NJR) for external model validation. A model was developed using a bootstrap ranking procedure with a least absolute shrinkage and selection operator (LASSO) logistic regression model combined with piecewise linear regression. Discriminative ability was evaluated by the area under the receiver operating characteristic curve (AUC). Calibration belt plots were used to assess model calibration. RESULTS: A main effects model combining age, sex, American Society for Anesthesiologists (ASA) class, the presence of cancer, diseases of the central nervous system, kidney disease, and diagnosed obesity had good discrimination, both internally (AUC = 0.78, 95% confidence interval (CI) 0.75 to 0.81) and externally (AUC = 0.75, 95% CI 0.73 to 0.76). This model was superior to traditional models based on the Charlson (AUC = 0.66, 95% CI 0.62 to 0.70) and Elixhauser (AUC = 0.64, 95% CI 0.59 to 0.68) comorbidity indices. The model was well calibrated for predicted probabilities up to 5%. CONCLUSION: We developed a parsimonious model that may facilitate individualized risk assessment prior to one of the most common surgical interventions. We have published a web calculator to aid clinical decision-making. Cite this article: Bone Joint J 2021;103-B(3):469-478.

International variation in distribution of ASA class in patients undergoing total hip arthroplasty and its influence on mortality: data from an international consortium of arthroplasty registries.

Background and purpose - A challenge comparing outcomes from total hip arthroplasty between countries is variation in preoperative characteristics, particularly comorbidity. Therefore, we investigated between-country variation in comorbidity in patients based on ASA class distribution, and determined any variation of ASA class to mortality risk between countries.Patients and methods - All arthroplasty registries collecting ASA class and mortality data in patients with elective primary THAs performed 2012-2016 were identified. Survival analyses of the influence of ASA class on 1-year mortality were performed by individual registries, followed by meta-analysis of aggregated data.Results - 6 national registries and 1 US healthcare organization registry with 418,916 THAs were included. There was substantial variation in the proportion of ASA class III/IV, ranging from 14% in the Netherlands to 39% in Finland. Overall, 1-year mortality was 0.93% (95% CI 0.87-1.01) and increased from 0.2% in ASA class I to 8.9% in class IV. The association between ASA class and mortality measured by hazard ratios (HR) was strong in all registries even after adjustment for age and sex, which reduced them by half in all registries. Combined adjusted HRs were 2.0, 6.1, and 22 for ASA class II-IV vs. I, respectively. Associations were moderately heterogeneous across registries.Interpretation - We observed large variation in ASA class distribution between registries, possibly explained by differences in background morbidity and/or international variation in access to surgery. The similar, strong mortality trends by ASA class between countries enhance the relevance of its use as an indicator of comorbidity in international registry studies.

Similar early mortality risk after cemented compared with cementless total hip arthroplasty for primary osteoarthritis: data from 188,606 surgeries in the Nordic Arthroplasty Register Association database.

Background and purpose - Current literature indicates no difference in 90-day mortality after cemented compared with cementless total hip arthroplasty (THA). However, previous studies are hampered by potential selection bias and suboptimal adjustment for comorbidity confounding. Therefore, we examined the comorbidity-adjusted mortality up to 90 days after cemented compared with cementless THA performed due to osteoarthritis.Patients and methods - Using the Nordic Arthroplasty Register Association database, 2005-2013, we included 108,572 cemented and 80,034 cementless THA due to osteoarthritis. We calculated the Charlson comorbidity index of each patient based on data from national patient registers. The Kaplan-Meier method was used to estimate unadjusted all-cause mortality. Cox regression was used to estimate hazard ratios (HR) with 95% confidence intervals (CI) for 14, 30-, and 90-day mortality comparing cemented with cementless THA, adjusting for age, sex, comorbidity, nation, and year of surgery.Results - Cumulative all-cause mortality within 90 days was 0.41% (CI 0.37-0.46) after cemented and 0.26% (CI 0.22-0.30) after cementless THA. The adjusted HR for cemented vs. cementless fixation was 0.97 (CI 0.79-1.2), and similar risk estimates were obtained for mortality within 14 (adjusted HR 0.91 [CI 0.64-1.3]) and 30 days (adjusted HR 0.94 [CI 0.71-1.3]). We found no clinically relevant differences in mortality between cemented and cementless THA in analyses stratified by age, sex, Charlson comorbidity index, or year of surgery.Interpretation - After adjustment for comorbidity as an important confounder, we observed similar early mortality between the 2 fixation techniques.

The bi-factor structure of the 17-item Hamilton Depression Rating Scale in persistent major depression; dimensional measurement of outcome.

BACKGROUND: The 17-item Hamilton Depression Rating Scale (HDRS17) is used world-wide as an observer-rated measure of depression in randomised controlled trials (RCTs) despite continued uncertainty regarding its factor structure. This study investigated the dimensionality of HDRS17 for patients undergoing treatment in UK mental health settings with moderate to severe persistent major depressive disorder (PMDD). METHODS: Exploratory Structural Equational Modelling (ESEM) was performed to examine the HDRS17 factor structure for adult PMDD patients with HDRS17 score ≥16. Participants (n = 187) were drawn from a multicentre RCT conducted in UK community mental health settings evaluating the outcomes of a depression service comprising CBT and psychopharmacology within a collaborative care model, against treatment as usual (TAU). The construct stability across a 12-month follow-up was examined through a measurement equivalence/invariance (ME/I) procedure via ESEM. RESULTS: ESEM showed HDRS17 had a bi-factor structure for PMDD patients (baseline mean (sd) HDRS17 22.6 (5.2); 87% PMDD >1 year) with an overall depression factor and two group factors: vegetative-worry and retardation-agitation, further complicated by negative item loading. This bi-factor structure was stable over 12 months follow up. Analysis of the HDRS6 showed it had a unidimensional structure, with positive item loading also stable over 12 months. CONCLUSIONS: In this cohort of moderate-severe PMDD the HDRS17 had a bi-factor structure stable across 12 months with negative item loading on domain specific factors, indicating that it may be more appropriate to multidimensional assessment of settled clinical states, with shorter unidimensional subscales such as the HDRS6 used as measures of change.

No generally increased risk of cancer after total hip arthroplasty performed due to osteoarthritis.

Previous studies on the risk of cancer after total hip arthroplasty (THA) contradict each other, and many are hampered by small cohort sizes, residual confounding, short observation times or a mix of indications underlying the THA procedure. We evaluated the risk of cancer after total hip arthroplasty due to osteoarthritis in a nationwide cohort by comparing cancer incidences in individuals exposed to total hip arthroplasty due to osteoarthritis and in unexposed, sex-, age- and residence matched individuals. To address some previous studies' shortcomings, information on comorbidity and socioeconomic background were obtained and adjusted for. We included 126,276 patients exposed to a cemented THA between 1992 and 2012, and 555,757 unexposed individuals. Follow-up started on the day of surgery for exposed individuals and respective date for matched, unexposed individuals, and ended on the day of death, emigration, censuring or December 31st, 2012, whichever came first. The Swedish Hip Arthroplasty Registry (SHAR), the Swedish Cancer Registry, the Swedish National Patient Registry and Statistics Sweden were accessed to obtain information on procedural details of the THA, cancer diagnoses, comorbidities, and socioeconomic background. The primary outcome measure was the occurrence of any cancer after the index date. Exposed individuals had a slightly lower adjusted risk of developing any cancer than unexposed individuals (hazard ratio [HR] 0.97; CI 0.95-0.99). The only cancer with a statistically significant risk increase in exposed individuals was skin melanoma (HR 1.15; CI 1.05-1.24). We attained similar risk estimates in analyses stratified by sex, in individuals with minimum 5 years of follow-up, in an analysis including individuals with a history of previous cancer, and in patients with cementless THA. In this study on a large and well-defined population with long follow-up, we found no increased overall risk of cancer after THA. These reassuring findings could be included in the guidelines on preoperative information given to THA patients.

More hip complications after total hip arthroplasty than after hemi-arthroplasty as hip fracture treatment: analysis of 5,815 matched pairs in the Swedish Hip Arthroplasty Register.

Background and purpose - Total hip arthroplasty (THA) is increasing as treatment of displaced femoral neck fractures. Several studies compare hemiarthroplasty (HA) with THA, but results vary and few studies report on medical complications. We examined the outcome of THA and HA with a focus on medical complications, hip complications, and death.Patients and methods - Data from the Swedish Hip Arthroplasty Register on 30,953 acute hip fracture patients treated with cemented THA or HA in 2005-2011 were cross-matched with Statistics Sweden for socioeconomic data and with the National Patient Register for diagnostic codes representing medical complications within 180 days or hip complications within the study period. Propensity score matching was used to create comparable groups based on age, sex, income, level of education, marital status, Elixhauser index, and year of surgery. Logistic regression models were created for each outcome.Results - 81% were treated with HA, 73% and 71% were female (HA and THA respectively). Matching resulted in 2 groups of 5,815 patients each. THA was associated with fewer medical complications (OR = 0.83; 95% CI 0.76-0.91) and lower 1-year mortality (OR = 0.42; CI 0.38-0.48), but more hip complications (OR = 1.31; CI 1.20-1.43).Interpretation - THA as treatment of hip fracture was associated with more hip-related complications than HA. The results on mortality and medical complications are, rather, influenced by residual confounding than by the implant design per se. An expansive use of THAs for hip fracture treatment, at the expense of HAs, is not recommended based on our findings if hip complications are to be avoided.

Aseptic loosening after total hip arthroplasty and the risk of cardiovascular disease: A nested case-control study.

BACKGROUND: Patients with surgically treated osteoarthritis of the hip have an increased risk of cardiovascular morbidity and mortality many years after the operation compared with controls. Our hypothesis is that this increased risk after total hip arthroplasty (THA) is mediated by development of periprosthetic osteolysis leading to aseptic loosening of the implant. METHODS: We conducted a nation-wide, nested, case-control study consisting of patients receiving a cemented THA due to osteoarthritis between the years 1992 and 2005. Our study population included a total of 14,430 subjects identified in the Swedish hip arthroplasty register and linked to the Swedish National Patient Register. The case group consisted of patients (n = 2,886) who underwent reoperation of the treated hip due to osteolysis or aseptic loosening at any time within five years after the index surgery. Each case was matched with four controls (n = 11,544) who had not undergone reoperation. The main outcomes were cardiovascular events i.e. myocardial infarction, heart failure and cerebral infarction according to ICD-codes and time to the first cardiovascular event during the exposure period. Outcomes were subgrouped into cardiac and cerebral events. We used regression models to calculate the incidence rates and adjusted our results for confounders. FINDINGS: Overall, 5.1% of patients had cardiac events, with slightly more overall cardiovascular events occurring in the control group (8.1% vs. 6.7%, odds ratio 0.8, 95% confidence interval (CI) 0.7 to 1.0). After adjusting for confounders, the case group had an increased relative risk of 1.3 (95% confidence interval (CI) 1.1 to 1.3) for total number of cardiovascular events. Similar effect sizes were observed for time to first event. INTERPRETATION: Patients with osteoarthritis who received THA and subsequently underwent a revision operation due to loosening had a higher relative risk of developing cardiovascular events than controls. Thus there is an association which could be explained by a common inflammatory disease pathway that requires further experimental research.

How is a specialist depression service effective for persistent moderate to severe depressive disorder?: a qualitative study of service user experience.

BACKGROUND: A specialist depression service (SDS) offering collaborative pharmacological and cognitive behaviour therapy treatment for persistent depressive disorder showed effectiveness against depression symptoms versus usual community based multidisciplinary care in a randomised controlled trial (RCT) in specialist mental health services in England. However, there is uncertainty concerning how specialist depression services effect such change. The current study aimed to evaluate the factors which may explain the greater effectiveness of SDS compared to Treatment as Usual (TAU) by exploring the experience of the RCT participants. METHODS: Qualitative audiotaped and transcribed semi-structured interviews were conducted 12-18 months after baseline with 21 service users (12 SDS, 9 TAU arms) drawn from all three sites. Inductive thematic analysis using a grounded approach contrasted the experiences of SDS with TAU participants. RESULTS: Four themes emerged in relation to service user experience: 1. Specific treatment components of the SDS: which included sub-themes of the management of medication change, explaining and developing treatment strategies, setting realistic expectations, and person-centred and holistic approach; 2. Individual qualities of SDS clinicians; 3. Collaborative team context in SDS: which included sub-themes of communication between healthcare professionals, and continuity of team members; 4. Accessibility to SDS: which included sub-themes of flexibility of locations, frequent consultation as reinforcement, gradual pace of treatment, and challenges of returning to usual care. CONCLUSIONS: The study uncovered important mechanisms and contextual factors in the SDS that service users experience as different from TAU, and which may explain the greater effectiveness of the SDS: the technical expertise of the healthcare professionals, personal qualities of clinicians, teamwork, gradual pace of care, accessibility and managing service transitions. Usual care in other specialist mental health services may share many of the features from the SDS. TRIAL REGISTRATION: "Trial of the Clinical and Cost Effectiveness of a Specialist Expert Mood Disorder Team for Refractory Unipolar Depressive Disorder" was registered in www.ClinicalTrials.gov ( NCT01047124 ) on 12-01-2010 and the ISRCTN registry was registered in www.isrctn.com ( ISRCTN10963342 ) on 25-11-2015 (retrospectively registered).

Do Patients Live Longer After THA and Is the Relative Survival Diagnosis-specific?

BACKGROUND: Hip replacements are successful in restoring mobility, reducing pain, and improving quality of life. However, the association between THA and the potential for increased life expectancy (as expressed by mortality rate) is less clear, and any such association could well be influenced by diagnosis and patient-related, socioeconomic, and surgical factors, which have not been well studied. QUESTIONS/PURPOSES: (1) After controlling for birth year and sex, are Swedish patients who underwent THA likely to survive longer than individuals in the general population? (2) After controlling for relevant patient-related, socioeconomic/demographic factors and surgical factors, does relative survival differ across the various diagnoses for which THAs were performed in Sweden? METHODS: Data from the Swedish Hip Arthroplasty Register, linked to administrative health databases, were used for this study. We identified 131,808 patients who underwent THA between January 1, 1999, and December 31, 2012. Of these, 21,755 had died by the end of followup. Patient- and surgery-specific data in combination with socioeconomic data were available for analysis. We compared patient survival (relative survival) with age- and sex-matched survival data in the entire Swedish population according to Statistics Sweden. We used multivariable modeling proceeded with a Cox proportional hazards model in transformed time. RESULTS: Patients undergoing elective THA had a slightly improved survival rate compared with the general population for approximately 10 years after surgery. At 1 year after surgery, the survival in patients undergoing THA was 1% better than the expected survival (r = 1.01; 95% confidence interval [CI], 1.01-1.02; p < 0.001); at 5 years, this increased to 3% (r = 1.03; 95% CI, 1.03-1.03; p < 0.001); at 10 years, the difference was 2% (r = 1.02; 95% CI, 1.02-1.03; p < 0.001); and by 12 years, there was no difference between patients undergoing THA and the general population (r = 1.01; 95% CI, 0.99-1.02; p = 0.13). Using the diagnosis of primary osteoarthritis as a reference, hip arthroplasties performed for sequelae of childhood hip diseases had a similar survival rate (hazard ratio [HR], 1.02; 95% CI, 0.88-1.18; p = 0.77). Patients undergoing surgery for osteonecrosis of the femoral head (HR, 1.69; 95% CI, 1.60-1.79; p < 0.001), inflammatory arthritis (HR, 1.49; 95% CI, 1.38-1.61; p < 0.001), and secondary osteoarthritis (HR, 2.46; 95% CI, 2.03-2.99; p < 0.001) all had poorer relative survival. Comorbidities and the Elixhauser comorbidity index had a negative association with relative survival. Level of achieved education (middle level of education: HR, 0.90, 95% CI, 0.87-0.93, p < 0.001; high level: 0.76, 95% CI, 0.73-0.80, p < 0.001) and marital status (single status: HR, 1.33; 95% CI, 1.28-1.38; p < 0.001) were also negatively associated with survival. CONCLUSIONS: Whereas it has been known that in most patients, THA improves quality of life, this study demonstrates that it also is associated with a slightly increased life expectancy that lasts for approximately 10 years after surgery, especially among patients whose diagnosis was primary osteoarthritis. This adds further proof of a health-economic value for this surgical intervention. The reasons for the increase in relative survival are unknown but are probably multifactorial. LEVEL OF EVIDENCE: Level III, therapeutic study.

Factor structure and longitudinal measurement invariance of PHQ-9 for specialist mental health care patients with persistent major depressive disorder: Exploratory Structural Equation Modelling.

BACKGROUND: The Patient Health Questionnaire-9 (PHQ-9) is a widely used instrument for measuring levels of depression in patients in clinical practice and academic research; its factor structure has been investigated in various samples, with limited evidence of measurement equivalence/invariance (ME/I) but not in patients with more severe depression of long duration. This study aims to explore the factor structure of the PHQ-9 and the ME/I between treatment groups over time for these patients. METHODS: 187 secondary care patients with persistent major depressive disorder (PMDD) were recruited to a randomised controlled trial (RCT) with allocation to either a specialist depression team arm or a general mental health arm; their PHQ-9 score was measured at baseline, 3, 6, 9 and 12 months. Exploratory Structural Equational Modelling (ESEM) was performed to examine the factor structure for this specific patient group. ME/I between treatment arm at and across follow-up time were further explored by means of multiple-group ESEM approach using the best-fitted factor structure. RESULTS: A two-factor structure was evidenced (somatic and affective factor). This two-factor structure had strong factorial invariance between the treatment groups at and across follow up times. LIMITATIONS: Participants were largely white British in a RCT with 40% attrition potentially limiting the study's generalisability. Not all two-factor modelling criteria were met at every time-point. CONCLUSION: PHQ-9 has a two-factor structure for PMDD patients, with strong measurement invariance between treatment groups at and across follow-up time, demonstrating its validity for RCTs and prospective longitudinal studies in chronic moderate to severe depression.

Early mortality and morbidity after total hip arthroplasty in patients with femoral neck fracture.

Background and purpose - Early postoperative mortality is relatively high after total hip arthroplasty (THA) that has been performed due to femoral neck fracture. However, this has rarely been investigated after adjustment for medical comorbidity and comparison with the mortality in an age-matched population. We therefore assessed early mortality in hip fracture patients treated with a THA, in the setting of a nationwide matched cohort study. Patients and methods - 24,699 patients who underwent THA due to a femoral neck fracture between 1992 and 2012 were matched with 118,518 controls. Kaplan-Meier survival analysis was used to calculate cumulative unadjusted survival, and Cox regression models were fitted to compute hazard ratios (HRs) and 95% confidence intervals (CIs), with adjustment for age, sex, comorbidity, and socioeconomic background. Results - 90-day survival was 96.3% (95% CI: 96.0-96.5) for THA cases and 98.7% (95% CI: 98.6-98.8) for control individuals, giving an adjusted HR of 2.2 (95% CI: 2.0-2.4) for THA cases compared to control individuals. Comorbidity burden increased in THA cases over time, but the adjusted risk of death within 90 days did not differ statistically significantly between the time periods investigated (1992-1998, 1999-2005, and 2006-2012). A Charlson comorbidity index of 3 or more, an American Society of Anesthesiologists (ASA) grade of 3 and above, male sex, an age of 80 years and above, an income below the first quartile, and a lower level of education were all associated with an increased risk of 90-day mortality. Interpretation - The adjusted early mortality in femoral neck fracture patients who underwent THA was about double that in a matched control population. Patients with femoral neck fracture but with no substantial comorbidity and an age of less than 80 years appear to have a low risk of early death. Patients older than 80 years and those with a Charlson comorbidity index of more than 2 have a high risk of early death, and such patients would perhaps benefit from treatment strategies other than THA, but this should be investigated further.

Efficacy and cost-effectiveness of a specialist depression service versus usual specialist mental health care to manage persistent depression: a randomised controlled trial.

BACKGROUND: Persistent moderate or severe unipolar depression is common and expensive to treat. Clinical guidelines recommend combined pharmacotherapy and psychotherapy. Such treatments can take up to 1 year to show an effect, but no trials of suitable duration have been done. We investigated the efficacy and cost-effectiveness of outpatient-based, specialist depression services (SDS) versus treatment as usual (TAU) on depression symptoms and function. METHODS: We did a multicentre, single-blind, patient-level, parallel, randomised controlled trial (RCT), as part of the National Institute for Health Research (NIHR) Collaboration for Leadership in Applied Health Research and Care (CLAHRC) study, in three mental health outpatient settings in England. Eligible participants were in secondary care, were older than 18 years, had unipolar depression (with a current major depressive episode, a 17-item Hamilton Depression Rating Scale [HDRS17] score of ≥16, and a Global Assessment of Function [GAF] score of ≤60), and had not responded to 6 months or more of treatment for depression. Randomisation was stratified by site with allocation conveyed to a trial administrator, with research assessors masked to outcome. Patients were randomised (1:1) using a computer-generated pseudo-random code with random permuted blocks of varying sizes of two, four, or six to either SDS (collaborative care approach between psychiatrists and cognitive behavioural therapists for 12 months, followed by graduated transfer of care up to 15 months) or to the TAU group. Intention-to-treat primary outcome measures were changes in HDRS17 and GAF scores between baseline and 6, 12, and 18 months' follow-up. We will separately publish follow-up outcomes for months 24 and 36. Clinical efficacy and cost-effectiveness were examined from health and social care persp ectives at 18 months, as recommended by the National Institute for Health and Care Excellence. This trial is registered at ClinicalTrials.gov (NCT01047124) and the ISRCTN registry (ISRCTN10963342); the trial has ended. FINDINGS: 307 patients were assessed for eligibility between Dec 21, 2009, and Oct 31, 2012. 94 patients were assigned to TAU and 93 patients to SDS, and were included in intention-to-treat analyses. The changes from baseline to 6 months in HDRS17 and GAF scores did not significantly differ between treatment groups (mean change difference in HDRS17 score -1·01 [95% CI -3·30 to 1·28], p=0·385; and in GAF score 1·33 [-2·92 to 5·57], p=0·538). Primary outcome data were available for 134 (72%) patients at 12 months. We noted no differences at 12 months' follow-up between SDS and TAU for mean HDRS17 score (14·8 [SD 7·9] in the SDS group vs 17·2 [7·3] in the TAU group, p=0·056) or GAF score (60·4 [11·7] vs 55·8 [12·7], p=0·064), and the changes from baseline to 12 months in HDRS17 and GAF scores did not significantly differ between treatment groups (mean change difference in HDRS17 score -2·45 [95% CI -5·04 to 0·14], p=0·064; and in GAF score 4·12 [-0·11 to 8·35], p=0·056). The mean change in HDRS17 score from baseline to 18 months was significantly improved in the SDS group compared with the TAU group (13·6 [SD 8·8] in the SDS group vs 16·1 [6·6] in the TAU group; mean change difference -2·96 [95% CI -5·33 to -0·59], p=0·015), but the GAF scores showed no significant differences between the groups (61·2 [SD 13·0] vs 57·7 [11·9]; mean change difference 3·82 [-9·3 to 8·57], p=0·113). We reported no deaths, but one (1%) patient was admitted to hospital for myocardial infarction, and three episodes of self-harm were reported in three (2%) patients (two receiving TAU, one receiving SDS care). The incremental cost-effectiveness ratio of SDS versus TAU was £43 603 per quality-adjusted life-year. INTERPRETATION: Compared with usual specialist mental health secondary care, SDS might improve depression symptoms for patients with persistent moderate to severe depression, but functional outcomes and economic benefits are equivocal. FUNDING: National Institute for Health Research Collaboration for Leadership in Applied Health Research and Care, UK Medical Research Council, Nottinghamshire Healthcare NHS Foundation Trust, Derbyshire Healthcare NHS Foundation Trust, Cambridgeshire and Peterborough NHS Foundation Trust, University of Nottingham.

Increased Long-Term Cardiovascular Risk After Total Hip Arthroplasty: A Nationwide Cohort Study.

Total hip arthroplasty is a common and important treatment for osteoarthritis patients. Long-term cardiovascular effects elicited by osteoarthritis or the implant itself remain unknown. The purpose of the present study was to determine if there is an increased risk of late cardiovascular mortality and morbidity after total hip arthroplasty surgery.A nationwide matched cohort study with data on 91,527 osteoarthritis patients operated on, obtained from the Swedish Hip Arthroplasty Register. A control cohort (n = 270,688) from the general Swedish population was matched 1:3 to each case by sex, age, and residence. Mean follow-up time was 10 years (range, 7-21).The exposure was presence of a hip replacement for more than 5 years. The primary outcome was cardiovascular mortality after 5 years. Secondary outcomes were total mortality and re-admissions due to cardiovascular events.During the first 5 to 9 years, the arthroplasty cohort had a lower cardiovascular mortality risk compared with the control cohort. However, the risk in the arthroplasty cohort increased over time and was higher than in controls after 8.8 years (95% confidence interval [CI] 7.0-10.5). Between 9 and 13 years postoperatively, the hazard ratio was 1.11 (95% CI 1.05-1.17). Arthroplasty patients were also more frequently admitted to hospital for cardiovascular reasons compared with controls, with a rate ratio of 1.08 (95% CI 1.06-1.11).Patients with surgically treated osteoarthritis of the hip have an increased risk of cardiovascular morbidity and mortality many years after the operation when compared with controls.

Early postoperative mortality after simultaneous or staged bilateral primary total hip arthroplasty: an observational register study from the Swedish Hip Arthroplasty Register.

BACKGROUND: Approximately a fifth of all total hip arthroplasty (THA) patients suffers from bilateral osteoarthritis of the hip. It is unclear whether mortality risks differ between simultaneous bilateral THA and staged bilateral THA. We investigated mortality after simultaneous THA compared with staged bilateral THA in the largest cohort hitherto reported. METHODS: The 42,238 patients reported to have received bilateral primary THA from 1992 to 2012 in the Swedish Hip Arthroplasty Register were included. Tumours and fractures as underlying diagnoses were excluded. The time interval between the first and second THA was divided into four categories or treated as a continuous variable. Unadjusted survival was calculated according to Kaplan-Meier and adjusted Cox regression models were fitted in order to calculate crude and adjusted hazard ratios (HR) for the risk of death within different time frames. RESULTS: Patients selected for simultaneous bilateral surgery were younger, more often male, and had lower ASA (American Society of Anesthesiologists) class than patients receiving staged procedures. The adjusted 90-day mortality after the second procedure did not differ between the four investigated groups (simultaneous bilateral [HR 1.3, CI 0.5-3.3], surgeries within 6 months [HR 1.1, CI 0.6-2.0], surgeries between 7 and 12 months [HR 0.7, CI 0.4-1.2], with second surgery after >12 months as the reference group). For patients older than 75 years, men, patients with ASA class 3 or above, and for patients with rheumatoid arthritis (RA) the 90-day mortality was increased. The unadjusted risk of implant revision of any hip was slightly higher for patients with simultaneous bilateral THA compared to those with staged procedure within one year, but after adjustment for age, gender, diagnosis and implant fixation these differences were no longer statistically significant. CONCLUSION: There were no clinically relevant differences in early postoperative mortality between simultaneous and staged bilateral surgery in healthy patients. Advanced age, RA, a high ASA class and male sex increased the risk of death within 90 days. There may be an issue with enhanced risk of implant revision in patients with simultaneous bilateral THA that needs to be explored further.

Clinical effectiveness and cost-effectiveness of cognitive behavioural therapy as an adjunct to pharmacotherapy for treatment-resistant depression in primary care: the CoBalT randomised controlled trial.

BACKGROUND: Only one-third of patients with depression respond fully to treatment with antidepressant medication. However, there is little robust evidence to guide the management of those whose symptoms are 'treatment resistant'. OBJECTIVE: The CoBalT trial examined the clinical effectiveness and cost-effectiveness of cognitive behavioural therapy (CBT) as an adjunct to usual care (including pharmacotherapy) for primary care patients with treatment-resistant depression (TRD) compared with usual care alone. DESIGN: Pragmatic, multicentre individually randomised controlled trial with follow-up at 3, 6, 9 and 12 months. A subset took part in a qualitative study investigating views and experiences of CBT, reasons for completing/not completing therapy, and usual care for TRD. SETTING: General practices in Bristol, Exeter and Glasgow, and surrounding areas. PARTICIPANTS: Patients aged 18-75 years who had TRD [on antidepressants for ≥ 6 weeks, had adhered to medication, Beck Depression Inventory, 2nd version (BDI-II) score of ≥ 14 and fulfilled the International Classification of Diseases and Related Health Problems, Tenth edition criteria for depression]. Individuals were excluded who (1) had bipolar disorder/psychosis or major alcohol/substance abuse problems; (2) were unable to complete the questionnaires; or (3) were pregnant, as were those currently receiving CBT/other psychotherapy/secondary care for depression, or who had received CBT in the past 3 years. INTERVENTIONS: Participants were randomised, using a computer-generated code, to usual care or CBT (12-18 sessions) in addition to usual care. MAIN OUTCOME MEASURES: The primary outcome was 'response', defined as ≥ 50% reduction in depressive symptoms (BDI-II score) at 6 months compared with baseline. Secondary outcomes included BDI-II score as a continuous variable, remission of symptoms (BDI-II score of < 10), quality of life, anxiety and antidepressant use at 6 and 12 months. Data on health and social care use, personal costs, and time off work were collected at 6 and 12 months. Costs from these three perspectives were reported using a cost-consequence analysis. A cost-utility analysis compared health and social care costs with quality adjusted life-years. RESULTS: A total of 469 patients were randomised (intervention: n = 234; usual care: n = 235), with 422 participants (90%) and 396 (84%) followed up at 6 and 12 months. Ninety-five participants (46.1%) in the intervention group met criteria for 'response' at 6 months compared with 46 (21.6%) in the usual-care group {odds ratio [OR] 3.26 [95% confidence interval (CI) 2.10 to 5.06], p < 0.001}. In repeated measures analyses using data from 6 and 12 months, the OR for 'response' was 2.89 (95% CI 2.03 to 4.10, p < 0.001) and for a secondary 'remission' outcome (BDI-II score of < 10) 2.74 (95% CI 1.82 to 4.13, p < 0.001). The mean cost of CBT per participant was £ 910, the incremental health and social care cost £ 850, the incremental QALY gain 0.057 and incremental cost-effectiveness ratio £ 14,911. Forty participants were interviewed. Patients described CBT as challenging but helping them to manage their depression; listed social, emotional and practical reasons for not completing treatment; and described usual care as mainly taking medication. CONCLUSIONS: Among patients who have not responded to antidepressants, augmenting usual care with CBT is effective in reducing depressive symptoms, and these effects, including outcomes reflecting remission, are maintained over 12 months. The intervention was cost-effective based on the National Institute for Health and Care Excellence threshold. Patients may experience CBT as difficult but effective. Further research should evaluate long-term effectiveness, as this would have major implications for the recommended treatment of depression. TRIAL REGISTRATION: Current Controlled Trials ISRCTN38231611.

Cost-effectiveness of cognitive-behavioural therapy as an adjunct to pharmacotherapy for treatment-resistant depression in primary care: economic evaluation of the CoBalT Trial.

BACKGROUND: Depression is expensive to treat, but providing ineffective treatment is more expensive. Such is the case for many patients who do not respond to antidepressant medication. AIMS: To assess the cost-effectiveness of cognitive-behavioural therapy (CBT) plus usual care for primary care patients with treatment-resistant depression compared with usual care alone. METHOD: Economic evaluation at 12 months alongside a randomised controlled trial. Cost-effectiveness assessed using a cost-consequences framework comparing cost to the health and social care provider, patients and society, with a range of outcomes. Cost-utility analysis comparing health and social care costs with quality-adjusted life-years (QALYs). RESULTS: The mean cost of CBT per participant was £910. The difference in QALY gain between the groups was 0.057, equivalent to 21 days a year of good health. The incremental cost-effectiveness ratio was £14 911 (representing a 74% probability of the intervention being cost-effective at the National Institute of Health and Care Excellence threshold of £20 000 per QALY). Loss of earnings and productivity costs were substantial but there was no evidence of a difference between intervention and control groups. CONCLUSIONS: The addition of CBT to usual care is cost-effective in patients who have not responded to antidepressants. Primary care physicians should therefore be encouraged to refer such individuals for CBT.