Comparative Effectiveness and Durability of Biologics in Clinical Practice: Month 12 Outcomes from the International, Observational Psoriasis Study of Health Outcomes (PSoHO).

INTRODUCTION: Given the chronic nature of psoriasis (PsO), more studies are needed that directly compare the effectiveness of different biologics over long observation periods. This study compares the effectiveness and durability through 12 months of anti-interleukin (IL)-17A biologics relative to other approved biologics in patients with moderate-to-severe psoriasis in a real-world setting. METHODS: The Psoriasis Study of Health Outcomes (PSoHO) is an ongoing 3-year, prospective, non-interventional cohort study of 1981 adults with chronic moderate-to-severe plaque psoriasis initiating or switching to a new biologic. The study compares the effectiveness of anti-IL-17A biologics with other approved biologics and provides pairwise comparisons of seven individual biologics versus ixekizumab. The primary outcome was defined as the proportion of patients who had at least a 90% improvement in Psoriasis Area and Severity Index score (PASI90) and/or a score of 0 or 1 in static Physician Global Assessment (sPGA). Secondary objective comparisons included the proportion of patients who achieved PASI90, PASI100, a Dermatology Life Quality Index (DLQI) score of 0 or 1, and three different measures of durability of treatment response. Unadjusted response rates are presented alongside the primary analysis, which uses frequentist model averaging (FMA) to evaluate the adjusted comparative effectiveness. RESULTS: Compared to the other biologics cohort, the anti-IL-17A cohort had a higher response rate (68.0% vs. 65.1%) and significantly higher odds of achieving the primary outcome at month 12. The two cohorts had similar response rates for PASI100 (40.5% and 37.1%) and PASI90 (53.9% and 51.7%) at month 12, with no significant differences between the cohorts in the adjusted analyses. At month 12, the response rates across the individual biologics were 53.5-72.6% for the primary outcome, 27.6-48.3% for PASI100, and 41.7-61.4% for PASI90. CONCLUSIONS: These results show the comparative effectiveness of biologics at 6 and 12 months in the real-world setting.

Speed of clinical improvement in the real-world setting from patient-reported Psoriasis Symptoms and Signs Diary: Secondary outcomes from the Psoriasis Study of Health Outcomes through 12 weeks.

BACKGROUND: Rapid skin improvement is a key treatment goal of patients with moderate-to-severe psoriasis (PsO). OBJECTIVES: To compare the speed of clinical improvement of approved biologics on the symptoms and signs of psoriasis assessed by patients using the validated Psoriasis Symptoms and Signs Diary (PSSD) through 12 weeks. METHODS: Psoriasis Study of Health Outcomes (PSoHO) is an international, prospective, non-interventional study that compares the effectiveness of anti-interleukin (IL)-17A biologics versus other biologics, together with pairwise comparisons of ixekizumab versus five individual biologics in patients with PsO. Using the PSSD 7-day recall period, patients assessed the symptoms (itch, skin tightness, burning, stinging and pain) and signs (dryness, cracking, scaling, shedding/flaking, redness and bleeding) of their psoriasis (0-10). Symptom and sign summary scores (0-100) are derived from the average of individual scores. Percentage change in summary scores and proportion of patients with clinically meaningful improvements (CMI) in PSSD summary and individual scores are evaluated weekly. Longitudinal PSSD data are reported as observed with treatment comparisons analysed using mixed model for repeated measures (MMRM) and generalized linear mixed models (GLMM). RESULTS: Across cohorts and treatments, eligible patients (n = 1654) had comparable baseline PSSD scores. From Week 1, the anti-IL-17A cohort achieved significantly larger score improvements in PSSD summary scores and a higher proportion of patients showed CMIs compared to the other biologics cohort through 12 weeks. Lower PSSD scores were associated with a greater proportion of patients reporting their psoriasis as no longer impacting their quality-of-life (DLQI 0,1) and a high level of clinical response (PASI100). Results also indicate a relationship between an early CMI in PSSD score at Week 2 and PASI100 score at Week 12. CONCLUSIONS: Treatment with anti-IL-17A biologics, particularly ixekizumab, resulted in rapid and sustained patient-reported improvements in psoriasis symptoms and signs compared with other biologics in a real-world setting.

Ixekizumab improves secondary lesional signs, pain and sexual health in patients with moderate-to-severe genital psoriasis.

BACKGROUND: Epithelial surface disruption in genital psoriatic lesions may manifest as erosions, fissures and/or ulcers, causing pain and significantly impacting a patient's sexual health. OBJECTIVE: To evaluate the impact of erosions, fissures and/or ulcers in genital psoriatic lesions on pain and sexual activity in patients with moderate-to-severe genital psoriasis (GenPs) and treatment responses to ixekizumab vs. placebo until Week 12. METHODS: This post hoc subgroup analysis of patients presenting with and without erosions, fissures and/or ulcers in genital lesions from a phase IIIb multicentre, randomized, double-blind, placebo-controlled study (IXORA-Q; NCT02718898) in 149 adults with moderate-to-severe GenPs treated with subcutaneous ixekizumab (80 mg every 2 weeks; n = 75) or placebo (n = 74) evaluated outcomes for clinician-rated GenPs severity (static Physician's Global Assessment of Genitalia; sPGA-G) and patient-reported genital pain and itch (Genital Psoriasis Symptoms Scale; GPSS) and sexual health (Genital Psoriasis Sexual Frequency Questionnaire; GenPs-SFQ). RESULTS: At baseline, 38% (n = 57) of patients presented with genital erosions, fissures and/or ulcers independent of overall body surface area involvement (<10% or ≥10%). These signs were associated with higher scores for disease severity (sPGA-G) and pain (GPSS) but not sexual health (GenPs-SFQ). Complete resolution of these signs was observed in 62% of ixekizumab-treated patients (25% for placebo) at Week 1 and 83% (21% for placebo) at Week 12. Patients treated with ixekizumab reported significant improvements in pain, itch, disease severity and sexual health over 12 weeks compared to placebo and irrespective of the presence/absence of genital erosions, fissures and/or ulcers at baseline. CONCLUSION: Ixekizumab led to rapid and sustained resolution of erosions, fissures and/or ulcers and significant improvements in GenPs severity, genital pain and sexual health. Ixekizumab may help to improve the well-being of patients with GenPs.

Matching-adjusted indirect comparison of efficacy in patients with moderate-to-severe plaque psoriasis treated with ixekizumab vs. secukinumab.

BACKGROUND: Head-to-head randomized studies comparing ixekizumab and secukinumab in the treatment of psoriasis are not available. OBJECTIVES: To assess efficacy and quality of life using matching-adjusted indirect comparisons for treatment with ixekizumab vs. secukinumab. METHODS: Psoriasis Area and Severity Index (PASI) improvement of at least 75%, 90% and 100% and Dermatology Life Quality Index (DLQI) 0/1 response rates for approved dosages of ixekizumab (160 mg at Week 0, then 80 mg every two weeks for the first 12 weeks) and secukinumab (300 mg at Weeks 0, 1, 2, 3 and 4, then 300 mg every 4 weeks) treatment were compared using data from active (etanercept and ustekinumab) and placebo-controlled studies. Comparisons were made using the Bucher (BU) method and two modified versions of the Signorovitch (SG) method (SG total and SG separate). Subsequently, results based on active treatment common comparators were combined using generic inverse-variance meta-analysis. RESULTS: In the meta-analysis of studies with active comparators, PASI 90 response rates were 12·7% [95% confidence interval (CI) 5·5-19·8, P = 0·0005], 10·0% (95% CI 2·1-18·0, P = 0·01) and 11·2% (95% CI 3·2-19·1, P = 0·006) higher and PASI 100 response rates were 11·7% (95% CI 5·9-17·5, P < 0·001), 12·7% (95% CI 6·0-19·4, P < 0·001) and 13·1% (95% CI 6·3-19·9, P < 0·001) higher for ixekizumab compared with secukinumab using BU, SG total and SG separate methods. PASI 75 results were comparable when SG methods were used and favoured ixekizumab when the BU method was used. Week 12 DLQI 0/1 response rates did not differ significantly. CONCLUSIONS: Ixekizumab had higher PASI 90 and PASI 100 responses at week 12 compared with secukinumab using adjusted indirect comparisons.

Association between teriparatide treatment persistence and adherence, and fracture incidence in Taiwan: analysis using the National Health Insurance Research Database.

UNLABELLED: Medication persistence and adherence are critical for osteoporosis outcomes. Using the Taiwan National Health Insurance Research Database, we found that persistence and adherence to teriparatide were low in Taiwanese patients with osteoporosis and that greater persistence and adherence were associated with a lower incidence of hip and other nonvertebral fractures. INTRODUCTION: The purpose of this study was to determine the persistence and adherence to teriparatide treatment in Taiwanese patients with osteoporosis, and to examine the association between persistence and adherence to teriparatide with fracture risks. METHODS: Medical and pharmacy claims for 4,692 patients with vertebral or hip fractures and teriparatide prescriptions between 2005 and 2008 were identified (Taiwan National Health Insurance Research Database). Persistence was the time from the start of treatment to the first 90-day gap between two teriparatide prescriptions. Adherence was the number of teriparatide pens (each pen is used over 1 month) prescribed over 24 months. Association of persistence and adherence to teriparatide with fracture incidence was assessed using adjusted Cox proportional hazards models. RESULTS: The proportion of patients persisting with teriparatide for >6 months and >12 months was 44.6 and 24.9 %, respectively. Over 24 months, 53.6 % of patients were adherent for >6 months and 33.9 % were adherent for >12 months. Patients persisting for >12 months had a significantly lower incidence of hip (adjusted hazard ratio [HR], 0.61 [95 % confidence interval (CI), 0.40-0.93], P = 0.0229) and nonvertebral fracture (HR, 0.79 [95 % CI, 0.63-0.99], P = 0.0462) compared with those who persisted for ≤12 months. Patients adherent for >12 months had a lower incidence of hip (HR, 0.66 [95 % CI, 0.46-0.96], P = 0.0286) and nonvertebral fracture (HR, 0.81 [95 % CI, 0.66-0.99], P = 0.0377) compared with those adherent for ≤12 months. CONCLUSIONS: Persistence and adherence to teriparatide over 24 months were low in Taiwanese patients with osteoporosis; greater adherence and persistence were associated with a lower incidence of nonvertebral fractures.

Cognitive exposure versus avoidance in patients with chronic pain: adherence matters.

BACKGROUND: Behavioural exposure methods can reduce pain-avoidance behaviours, but outcomes vary. One possible explanation is that patients employ cognitive (experiential) avoidance during behavioural exposure. If so, reducing cognitive avoidance during behavioural exposure should help. One option is interoceptive exposure (IE), which involves sustained exposure (via attention) to pain sensations. In order to test if IE could improve outcomes from behavioural exposure, this study with mixed chronic pain patients compared outcomes from a cognitive behavioural therapy (CBT) pain management programme incorporating either IE or distraction from pain. METHODS: One hundred forty chronic pain patients were randomly assigned to CBT + IE or CBT + distraction. Outcome measures included pain, disability, depression and medication. Measures reflecting degree of threat of pain were also employed (catastrophizing, fear-avoidance, pain self-efficacy and pain acceptance). An intention-to-treat approach, using mixed-effects model repeated measures, as well as conventional inferential statistical tests, effect sizes and reliable change indices were employed to evaluate the outcomes up to 1-year post-treatment. RESULTS: Significant improvements were achieved by both treatment conditions on all outcome measures and on measures reflecting the threatening nature of pain, with no differences between treatment conditions. CONCLUSIONS: The addition of IE to behavioural exposure did not improve outcomes. However, higher adherence to either attentional strategy was associated with larger effect sizes on all measures, suggesting factors shared by the two treatments could have contributed to the outcomes. Taken as a whole, the results suggest that increasing adherence to treatment strategies, possibly by motivational measures, would improve the overall outcomes of these interventions.

Frequency and outcomes of painful physical symptoms in a naturalistic population with major depressive disorder: an analysis of pooled observational studies focusing on subjects aged 65 years and over.

AIMS: To estimate the frequency of painful physical symptoms (PPS) in elderly subjects (≥ 65 years) with major depressive disorder (MDD) in real-world clinical conditions and to establish whether PPS are associated with poor depression outcomes, including more severe depression and worse health-related quality of life (HRQoL). METHODS: Observational studies of MDD that included assessment of PPS and elderly subjects were screened. Measures of PPS were based on the Somatic Symptom Inventory (SSI) or Visual Analogue Scale (VAS). Data from a variety of depressive symptom severity and HRQoL scales were used. Analysis cohorts were based on age [aged ≥ 65 years (elderly) or < 65 years (younger)] and/or PPS status (presence or absence); five subsets were used to examine specific outcomes in matched elderly subjects. RESULTS: Data from seven studies (representing 26 countries) were collated. Of the 11,477 subjects, 14% were aged ≥ 65 years and 71% were classified as having PPS (PPS+). PPS were more frequent in elderly subjects (74% vs. 70% of younger subjects) and were positively associated with being female and Hispanic, and negatively associated with being East Asian in the elderly. The presence of PPS was associated with more severe clinical symptomatology and comparatively poorer HRQoL in elderly subjects. CONCLUSIONS: PPS, although frequent in younger MDD patients, were slightly more frequent in elderly MDD patients and associated with comparatively poorer clinical and functional outcomes. As elderly patients report somatic symptoms more readily than emotional symptoms, physicians should consider depression in addition to physical causes when PPS are present.

Medication discontinuation with depot and oral antipsychotics in outpatients with schizophrenia: comparison of matched cohorts from a 12-month observational study.

AIMS: This study compared all-cause medication discontinuation (any switch, augmentation or medication discontinuation) in matched cohorts of patients with schizophrenia who were initiated on depot or oral antipsychotics. Other objectives included between-group comparisons of resource use, and clinical and functional outcomes. METHODS: This post hoc analysis of a one-year, multicentre, prospective, observational study included outpatients with schizophrenia who required a change in their antipsychotic medication because of a physician-perceived risk of medication non-adherence. Patients were matched 1 : 1 using an optimal algorithm with rank-based Mahalanobis distances. All-cause medication discontinuation was compared using the Klein and Moeschberger test for survival and hazard ratios (HR) with 95% confidence intervals (CI) were calculated using a Cox proportional hazards model, stratifying on matched pairs. RESULTS: Forty patients who initiated a depot antipsychotic could be matched to patients who initiated an oral antipsychotic. Fewer depot-treated patients discontinued their antipsychotic medication at least once compared with oral-treated patients [20% (8/40) vs. 40% (16/40)]. Depot-treated patients discontinued their medication later (Klein and Moeschberger test p = 0.025) and were less likely to discontinue their initial antipsychotic medication [HR = 0.33 (95% CI, 0.12-0.92), p = 0.033] than oral-treated patients. There were few differences in resource use and no differences in clinical and functional outcomes between cohorts. CONCLUSION: In this matched-cohort analysis, patients with schizophrenia who were considered to be non-adherent with their prior oral antipsychotics were less likely to discontinue their medication for any cause if they were initiated on depot compared with oral antipsychotics.

The number needed to treat for all-cause medication discontinuation in the treatment of schizophrenia: consistency across world geographies and study designs.

INTRODUCTION: The number needed to treat (NNT) for all-cause medication discontinuation in large, industry-sponsored, non-randomized, observational studies conducted across world geographies was compared with NNTs from CATIE, an 18-month, NIMH-sponsored, randomized study. METHODS: NNTs (with 95% confidence intervals) were calculated using data from 3 large Lilly-sponsored, non-randomized, observational studies (EU-SOHO, IC-SOHO, and US-SCAP, n=20 957). Group differences at medication initiation were adjusted by Cox regression modeling. These NNTs were compared with published NNTs for CATIE (phase 1). RESULTS: NNTs for olanzapine vs. risperidone and for olanzapine vs. quetiapine were similar across the observational studies and similar to those of CATIE. The NNTs for olanzapine vs. oral typical antipsychotics were similar across the observational studies but demonstrated a somewhat stronger effect size than the NNT reported for olanzapine vs. perphenazine in CATIE. DISCUSSION: NNTs for all-cause treatment discontinuation (a proxy measure of a medication's effectiveness from patients' and clinicians' perspectives) appear to be consistent across study designs (non-interventional, observational vs. RCT), study sponsorship (industry vs. independent), and across world geographies, suggesting that antipsychotics differ in this measure.

A prospective study of the impact of subthreshold mixed states on the 24-month clinical outcomes of bipolar I disorder or schizoaffective disorder.

OBJECTIVES: The clinical significance of subthreshold mixed states is unclear. This study investigated the clinical outcomes in participants with bipolar I disorder or schizoaffective disorder, using the Cassidy and Benazzi criteria for manic and depressive mixed states, respectively. METHODS: Participants (N=239) in a prospective observational study of treatment and outcomes in bipolar I or schizoaffective disorder, bipolar type, were grouped based on study entry clinical presentation as having pure depression (n=63) if they satisfied DSM-IV-TR criteria for a Major Depressive Episode (MDE), depressive mixed state if they also had at least three concurrent hypomanic symptoms (n=33), or not depressed (n=143) if they did not satisfy the criteria for MDE. Participants were similarly grouped as having pure mania (n=3) if they satisfied DSM-IV criteria for a Manic Episode, manic mixed state if they also had at least two concurrent depressive symptoms (n=33), or not manic (n=203). Clinical data were collected by interview every 3 months over a 24-month period. RESULTS: Measures of quality of life, mental and physical health over the 24-month period were significantly worse for participants who were classified as having mixed states at study entry on most outcome measures compared to participants who were not in an illness episode at study entry. A depressive mixed state was predictive of greater manic symptomatology over the 24 months compared to participants with pure depression. CONCLUSION: In participants with a current episode of mood disorder, the presence of subthreshold symptoms of opposite polarity was associated with poorer clinical outcomes over a 24-month period.

Chronic pain in Australia: a prevalence study.

This study reports chronic pain prevalence in a randomly selected sample of the adult Australian population. Data were collected by Computer-Assisted Telephone Interview (CATI) using randomly generated telephone numbers and a two-stage stratified sample design. Chronic pain was defined as pain experienced every day for three months in the six months prior to interview. There were 17,543 completed interviews (response rate=70.8%). Chronic pain was reported by 17.1% of males and 20.0% of females. For males, prevalence peaked at 27.0% in the 65--69 year age group and for females, prevalence peaked at 31.0% in the oldest age group (80--84 years). Having chronic pain was significantly associated with older age, female gender, lower levels of completed education, and not having private health insurance; it was also strongly associated with receiving a disability benefit (adjusted OR=3.89, P<0.001) or unemployment benefit (adjusted OR=1.99, P<0.001); being unemployed for health reasons (adjusted OR=6.41, P<0.001); having poor self-rated health (adjusted OR=7.24, P<0.001); and high levels of psychological distress (adjusted OR=3.16, P<0.001). Eleven per cent of males and 13.5% of females in the survey reported some degree of interference with daily activities caused by their pain. Prevalence of interference was highest in the 55--59 year age group in both males (17.2%) and females (19.7%). Younger respondents with chronic pain were proportionately most likely to report interference due to pain, affecting 84.3% of females and 75.9% of males aged 20--24 years with chronic pain. Within the subgroup of respondents reporting chronic pain, the presence of interference with daily activities caused by pain was significantly associated with younger age; female gender; and not having private health insurance. There were strong associations between having interfering chronic pain and receiving disability benefits (adjusted OR=3.31, P<0.001) or being unemployed due to health reasons (adjusted OR=7.94, P<0.001, respectively). The results show that chronic pain impacts upon a large proportion of the adult Australian population, including the working age population, and is strongly associated with markers of social disadvantage.

Determinants of willingness to pay for hip and knee joint replacement surgery for osteoarthritis.

OBJECTIVES: To determine whether patients with osteoarthritis (OA) would be willing to pay for joint replacement and whether patient characteristics or health outcomes, including pain, physical function and health-related quality of life, were related to willingness to pay (WTP). METHODS: Patients who had undergone primary total hip replacement (THR) or total knee replacement (TKR) for OA completed a disease-specific questionnaire (Western Ontario and McMaster: WOMAC index), a generic measure of health status (Medical Outcome Study Short Form-36: SF-36) and an Evaluation Questionnaire to measure WTP and satisfaction with the replacement. RESULTS: Responses were obtained from 109 (77%) THR patients and 129 (72%) TKR patients. Mean age of respondents was 67 yr for THR (47% female) and 73 yr for TKR (60% female). Overall, 85% of patients responded to the WTP question. Of the THR patients, 71% were willing to pay something, 11% were not willing to pay anything and 18% did not answer the question. For TKR patients these figures were 70, 16 and 14% respectively. However, of those who responded to the WTP question, only 25% of the THR patients and 18% of the TKR patients indicated they would be willing to pay the actual current average cost of the operation in Australia (>/= A$15 000). A lower postoperative pain score (as measured by the WOMAC index) was a significant predictor of WTP for both THR and TKR patients. Income also significantly predicted WTP in THR patients but not in TKR patients. The other significant predictors for TKR patients were older age, having private health insurance and willingness to recommend joint replacement to others. CONCLUSIONS: Willingness to pay was a measure that was understandable and acceptable to patients, most of whom were willing to pay something. There was a high correlation between WTP, good health outcomes and patient satisfaction, pain relief being the dominant determinant.

Mortality and morbidity after hip fracture: can evidence based clinical pathways make a difference?

OBJECTIVE: To evaluate whether evidence based clinical pathways for acute management of hip fracture have an effect on patient care, short term mortality, or residential status. METHODS: Observational cohort study comparing management, as determined by medical record review, and outcomes, as determined by telephone followup 4 months post-fracture, before (n = 455) and after (n = 481) clinical pathway implementation within pathway hospitals as well as between patients admitted to hospitals with (n = 2) and without (n = 4) pathways. RESULTS: Mean age was 82 years, 80% were women and 30% were admitted from nursing homes. Significant improvement in best practice as recommended by evidence based clinical guidelines was evident in pathway hospitals for most components of care. However, compliance was variable and nonpathway hospitals performed better for some (use of spinal anesthesia, avoidance of urinary catheters). After adjusting for potential confounders, no difference was found in 4 month mortality between the pathway (17.6%) and non-pathway (16.8%) patients (OR 0.8, 95% CI 0.5-1.5). There was a nonsignificant reduction in median acute care hospital length of stay of 1 day (p = 0.200) for non-nursing home patients and a significant reduction of 1 day (p = 0.038) for nursing home patients in the pathway hospitals. There was a nonsignificant decrease in admission rates for new patients to nursing homes in pathway hospitals (18.5%) compared to non-pathway hospitals (24.3%) (OR 0.5, 95% CI 0.3-1.1). CONCLUSION: Clinical pathways were associated with increased use of evidence based best practice, some reduction in acute hospital length of stay, but no significant effect on 4 month mortality or residential status. Their development and maintenance were resource intensive and further work on the implementation of evidence based guidelines is needed to determine whether they can influence patient outcomes.

Public health surveillance of hepatitis C: can it identify incident cases?

OBJECTIVES: To evaluate a follow-up system to identify incident cases among individuals notified with the hepatitis C virus (HCV). METHOD: A cross-sectional survey of medical practitioners treating individuals notified to the NSW Health Department as having HCV between August 1996 and August 1997 was conducted. RESULTS: Five hundred and fifty-four new notifications were received during the study period (70.7 per 100,000 people). Ninety-six per cent of notifications were followed up with 54 individuals (9.7%) identified as incident cases. Incident cases were significantly younger than prevalent cases (median age 30 vs. 39, p < 0.001) with drug and alcohol notifications being more likely to be incident cases. CONCLUSION: HCV transmission is continuing at relatively high levels with incident cases being significantly younger than prevalent cases. IMPLICATIONS: An efficient notification follow-up strategy that identifies incident cases could be routinely used to assess the effectiveness of population-based initiatives aimed at reducing HCV transmission.

Outcomes after hip or knee replacement surgery for osteoarthritis. A prospective cohort study comparing patients' quality of life before and after surgery with age-related population norms.

OBJECTIVE: To compare the health-related quality of life of people with osteoarthritis before and after primary total hip and knee replacement surgery with that of the general Australian population. DESIGN: A prospective cohort study. SETTING: Three Sydney hospitals, public and private. PARTICIPANTS: Patients with osteoarthritis undergoing primary total hip (n = 59) and knee (n = 92) joint replacement surgery. MAIN OUTCOME MEASURE: Medical Outcomes Study Short Form (SF-36) scores before and 12 months after joint replacement surgery (compared with population norms). RESULTS: Patients in each age group showed a significant improvement in health-related quality of life after joint replacement surgery in most scales of the SF-36, particularly physical function, role physical and bodily pain. SF-36 scores for the 42 hip-replacement patients aged 55-74 years improved to equal or exceed the population norm on all scales. SF-36 scores of the 52 knee replacement patients aged 55-74 years improved, but physical function and bodily pain scores remained significantly worse than the population norm. SF-36 scores for both hip (n = 17) and knee (n = 40) replacement patients aged 75 years and over improved significantly, becoming similar to population norms for this age group. CONCLUSIONS: Total hip or knee replacement for osteoarthritis significantly improves patient health and well-being at 12 months after surgery. Age alone should not be a barrier to surgery.

How best to fix a broken hip. Fractured Neck of Femur Health Outcomes Project Team.

OBJECTIVES: To develop evidence-based guidelines for the treatment of proximal femoral fractures to optimise functional outcome while minimising length of stay in hospital. DATA SOURCES: Systematic literature search of MEDLINE and CINAHL computer databases, bibliographies, and current contents of key journals for 1966-1995. STUDY SELECTION: English-language randomised controlled trials of all aspects of acute-care hospital treatment of proximal femoral fracture among subjects aged 50 years and over with proximal femoral fractures not due to metastatic disease. DATA EXTRACTION: Two independent reviewers, blinded to authors, institution and study results, followed a standard Cochrane Collaboration protocol and assessed study quality and treatment conclusions. When necessary, a third review was performed to reach consensus. RESULTS: Of the 120 articles published between 1966 and December 1995, 97 met the inclusion criteria. Fifteen clinical interventions were reviewed. Five were supported by National Health and Medical Research Council (NHMRC) level I evidence (prophylactic anticoagulants, prophylactic antibiotics, regional anaesthesia, pressure-relieving mattresses, and internal surgical fixation), two had no supporting randomised controlled trial evidence (time to surgery, time to mobilisation after surgery) and the remainder were classified as having Level II evidence. A review of current practice (1993-94) identified wide variability in these interventions across five acute-care hospitals in the Northern Sydney Area Health Service. CONCLUSIONS: Randomised controlled trial evidence (NHMRC Levels I and II) exists for many, but not all, aspects of hip fracture treatment. There is a need for changes to be made to some aspects of practice in accordance with evidence-based guidelines.