Reducing medicine-induced deterioration and adverse reactions (ReMInDAR) trial: study protocol for a randomised controlled trial in residential aged-care facilities assessing frailty as the primary outcome.

INTRODUCTION: Many medicines have adverse effects which are difficult to detect and frequently go unrecognised. Pharmacist monitoring of changes in signs and symptoms of these adverse effects, which we describe as medicine-induced deterioration, may reduce the risk of developing frailty. The aim of this trial is to determine the effectiveness of a 12-month pharmacist service compared with usual care in reducing medicine-induced deterioration, frailty and adverse reactions in older people living in aged-care facilities in Australia. METHODS AND ANALYSIS: The reducing medicine-induced deterioration and adverse reactions trial is a multicentre, open-label randomised controlled trial. Participants will be recruited from 39 facilities in South Australia and Tasmania. Residents will be included if they are using four or more medicines at the time of recruitment, or taking more than one medicine with anticholinergic or sedative properties. The intervention group will receive a pharmacist assessment which occurs every 8 weeks. The pharmacists will liaise with the participants' general practitioners when medicine-induced deterioration is evident or adverse events are considered serious. The primary outcome is a reduction in medicine-induced deterioration from baseline to 6 and 12 months, as measured by change in frailty index. The secondary outcomes are changes in cognition scores, 24-hour movement behaviour, grip strength, weight, percentage robust, pre-frail and frail classification, rate of adverse medicine events, health-related quality of life and health resource use. The statistical analysis will use mixed-models adjusted for baseline to account for repeated outcome measures. A health economic evaluation will be conducted following trial completion using data collected during the trial. ETHICS AND DISSEMINATION: Ethics approvals have been obtained from the Human Research Ethics Committee of University of South Australia (ID:0000036440) and University of Tasmania (ID:H0017022). A copy of the final report will be provided to the Australian Government Department of Health. TRIAL REGISTRATION NUMBER: Australian and New Zealand Trials Registry ACTRN12618000766213.

Twelve-Year Outcomes of an Oxinium Total Knee Replacement Compared with the Same Cobalt-Chromium Design: An Analysis of 17,577 Prostheses from the Australian Orthopaedic Association National Joint Replacement Registry.

BACKGROUND: Oxidized zirconium (Oxinium) was introduced as an alternative bearing surface to cobalt-chromium (CoCr) in an attempt to reduce polyethylene wear and decrease aseptic mechanical failure of total knee replacements. While noncomparative reports have been described as promising, we were aware of no short or long-term clinical studies showing the superiority of Oxinium on polyethylene as a bearing surface. Using data from a comprehensive national joint replacement registry, we compared the long-term outcomes after cruciate-retaining total knee arthroplasty (TKA) with an Oxinium femoral component and those with the same prosthetic design but with a CoCr femoral component. METHODS: The cohorts consisted of 17,577 cemented Genesis-II cruciate-retaining total knee replacements using non-cross-linked polyethylene, which included 11,608 with CoCr femoral components and 5,969 with Oxinium femoral components. The cumulative percent revision and hazard ratio (HR) for revision risk were estimated for the cemented Genesis-II Oxinium and CoCr cruciate-retaining TKAs performed in Australia from September 1, 1999, to December 31, 2013. In addition, the revision diagnoses and the effects of age and patellar resurfacing were examined. RESULTS: No difference in the HR for revision risk was found between the Oxinium and CoCr cohorts for any age category for all causes of revision (HR = 0.92 [95% confidence interval (CI), 0.92 to 1.29]; p = 0.329), loosening or lysis, or aseptic causes, except for loosening or lysis in the group of patients who were ≥75 years old (p = 0.033). In these patients, TKA with Oxinium femoral components had a higher rate of revision. Younger patients preferentially received Oxinium femoral components. The revision risk was not affected by patellar resurfacing or nonresurfacing. At 12 years, the cumulative percent revision was 4.8% (95% CI, 4.2% to 5.4%) for the CoCr Genesis-II prosthesis compared with 7.7% (95% CI, 6.2% to 9.5%) for the Oxinium Genesis-II prosthesis. CONCLUSIONS: In this cohort study involving the same prosthetic design, Oxinium femoral components did not reduce revision rates for all causes, loosening or lysis, or when infection as a cause of revision was removed compared with the same CoCr femoral component across all age groups including patients who were <55 years old. The cumulative percent revision was greater for the Oxinium components than for the CoCr components. LEVEL OF EVIDENCE: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

Depression in palliative care: a systematic review. Part 2. Treatment.

OBJECTIVE: To summarize available literature containing data on the treatment of depression in palliative care patients. METHODS: A systematic review was conducted using extensive electronic databases and hand searches. All randomized controlled trials (RCTs) of interventions for depression in patients with advanced disease were eligible. RESULTS: Three RCTs assessed pharmacological treatments. Of these, two were placebo controlled and assessed mianserin and thioridazine. The third compared two antidepressants. There were no RCTs that specifically assessed psychotherapy for patients with depression. CONCLUSION: There are too few adequate studies to draw clear conclusions about management of depression in this setting. The treatment of depression in patients with advanced disease must, for now, be informed by the larger body of evidence on effective treatments for depression in patients with either no physical illness or less severe medical conditions.