Factors Associated with Revision Surgery after Internal Fixation of Hip Fractures

Background: Femoral neck fractures are associated with high rates of revision surgery after management with internal fixation. Using data from the Fixation using Alternative Implants for the Treatment of Hip fractures (FAITH) trial evaluating methods of internal fixation in patients with femoral neck fractures, we investigated associations between baseline and surgical factors and the need for revision surgery to promote healing, relieve pain, treat infection or improve function over 24 months postsurgery. Additionally, we investigated factors associated with (1) hardware removal and (2) implant exchange from cancellous screws (CS) or sliding hip screw (SHS) to total hip arthroplasty, hemiarthroplasty, or another internal fixation device. Methods: We identified 15 potential factors a priori that may be associated with revision surgery, 7 with hardware removal, and 14 with implant exchange. We used multivariable Cox proportional hazards analyses in our investigation. Results: Factors associated with increased risk of revision surgery included: female sex, [hazard ratio (HR) 1.79, 95% confidence interval (CI) 1.25-2.50; P = 0.001], higher body mass index (fo

Impact of safety-related regulatory action on clinical practice: a systematic review

Background: After market approval, new serious safety issues are regularly identified for drugs that lead to regulatory action to inform healthcare professionals. However, the effectiveness of these safety-related regulatory actions is under question. We currently lack a comprehensive overview of the effects of these drug safety warnings on clinical practice to resolve the debate about their effectiveness. Objective: The aim of this systematic review is to provide an overview of studies that assessed the impact of safety warnings. Study Selection: A systematic search was performed for articles assessing the impact of Direct Healthcare Professional Communications or 'Dear Doctor' letters, Black Box Warnings and Public Health Advisories on clinical behaviour published between January 1996 and January 2010. The following variables were extracted: publication year, country, name of the drug, safety issue, specific safety warning (Direct Healthcare Professional Communication/Black Box Warning/Public Health Advisory), effect (intended/unintended) of the safety warning, outcome measure and study design. Papers were checked for several quality aspects. Study data were summarized using descriptive analyses. Results: A total of 50 articles were identified. Two articles assessed two different drugs and were therefore counted twice (n = 52). Thirty-three articles described the impact of safety warnings issued for three drugs and drug groups, i.e. third-generation oral contraceptives, cisapride and selective serotonin reuptake inhibitors. The remaining 19 articles described a broad variety of 14 drugs and drug groups. Twenty-five studies applied an interrupted time series design, 23 a controlled or uncontrolled before/after design, and four articles applied both. None of the articles could rule out the influence of confounding factors. The intended effects were reported in 18 (72%) of the 25 before/after analyses, whereas only 11 (41%) of the 27 interrupted time series analyses reported an impact. Only two (8%) of the before/after analyses against 11 (41%) of the interrupted time series analyses reported mixed impacts. When unintended effects were assessed in case of selective serotonin reuptake inhibitors and third-generation oral contraceptives, these were almost always present: in 19 of 22 and 4 of 5 articles, respectively. Our review shows that safety-related regulatory action can have some impact on clinical practice but firm conclusions are difficult to draw. Evidence is primarily based on three drugs and drug groups. Almost half of the studies had inadequate before/after designs and the heterogeneity in analyses and outcome measures hampered the reporting of overall effect sizes. Studies with adequate interrupted time series design reported a more mixed impact of safety warnings than before/after studies. Furthermore, this review shows the relevance of considering not only the intended but also the unintended effects of safety warnings. Conclusions: There is a clear need for further research with appropriate study designs and statistical analyses, with more attention to confounding factors such as media coverage, to understand the impact of safety-related regulatory action

The effective dose due to scattered radiation at patients during primary osteosynthesis; a multicenter prospective observational study

Objectives: During osteosynthesis of a fracture patients are exposed to the primary radiation of an X-ray image and scattered (secondary) radiation. The primary objective was to measure the amount of scattered radiation at the thyroid, breast tissue, and gonads of patients undergoing primary osteosynthesis of acute fractures. The secondary objective was to calculate the effective dose caused by scattered radiation. Methods: In this multicenter prospective observational case series patients undergoing a primary osteosynthesis of an acute fracture of hand/wrist, shoulder, ankle, knee, or hip were included. Three dosimeters were attached to the patient at the level of the thyroid, breast and gonads. Scattered radiation doses were corrected for the average background radiation per hospital per day. Results: A total of 205 patients were included between March 6, 2017 and June 18, 2018; 49 (24%) had a hand/wrist fracture, 37 (18%) a shoulder fracture, 47 (23%) an ankle fracture, 35 (17%) a knee fracture, and 37 (18%) a hip fracture. In 32–39% of all patients undergoing primary osteosynthesis effective scattered doses was detected. The highest measured median effective dose was 60.43 µSv (P25–P75 33.84–100.76) at the gonads during hip osteosynthesis. Conclusions: The results of this study show that scattered radiation is detectable in a third of patients undergoing an osteosynthesis. However, both effective doses due to direct radiation and scattered radiation are low. Advances in knowledge: This is the first study that presents that no radiation protection for patients undergoing an osteosynthesis is necessary.Support Biomechanical Engineerin

A pharmaceutical care program to improve adherence to statin therapy: a randomized controlled trial

BACKGROUND: Despite the well-known beneficial effects of statins, many patients do not adhere to chronic medication regimens. OBJECTIVE: To implement and assess the effectiveness of a community pharmacy based pharmaceutical care program developed to improve patients' adherence to statin therapy. METHODS: An open-label, prospective, randomized controlled trial was conducted at 26 community pharmacies in the Netherlands. New users of statins who were aged 18 years or older were randomly assigned to receive either usual care or a pharmacist intervention. The intervention consisted of 5 individual counseling sessions by a pharmacist during a 1-year period. During these sessions, patients received structured education about the importance of medication adherence, lipid levels were measured, and the association between adherence and lipid levels was discussed. Adherence to statin therapy was assessed as discontinuation rates 6 and 12 months after statin initiation, and as the medication possession ratio (MPR), and compared between the pharmaceutical care and usual care groups. RESULTS: A total of 899 subjects (439 in the pharmaceutical care group and 460 in the usual care group) were evaluable for effectiveness analysis. The pharmaceutical care program resulted in a significantly lower rate of discontinuation within 6 months after initiating therapy versus usual care (HR 0.66, 95% Cl 0.46 to 0.96). No significant difference between groups was found in discontinuation at 12 months (HR 0.84, 95% Cl 0.65 to 1.10). Median MPR was very high (>99%) in both groups and did not differ between groups. CONCLUSIONS: These results demonstrate the feasibility and effectiveness of a community pharmacy based pharmaceutical care program to improve medication adherence in new users of statins. Frequent counseling sessions (every 3 months) are necessary to maintain the positive effects on discontinuation. Although improvements are modest, the program can be applied easily to a larger population and have a large impact, as the interventions are relatively inexpensive and easy to, implement in clinical practice

Influence of the use of functional foods enriched with phytosterols/-stanols on adherence to statin therapy

Purpose Subjects using functional foods with approved health claims may be more likely to be non-adherent with prescribed drug therapy. This study aimed to assess the influence of the use of phytosterol/-stanol-enriched functional foods on adherence to statin therapy among patients initiating treatment. Methods We used data from the statin intervention research project, a randomized controlled trial aimed at improving adherence to statins. In the trial, new statin users were randomized to receive either usual care or extensive pharmaceutical care consisting of five individual counseling sessions. Customary use of phytosterol/-stanol-enriched products was identified by questionnaires filled out by all participants. Automated pharmacy-dispensing records were used to assess adherence in terms of discontinuation of therapy and the medication possession ratio. Analyses were performed for the overall population, as well as stratified for receiving pharmaceutical or usual care. Results The use of functional foods enriched with phytosterols/-stanols was not related to discontinuation of statin therapy, neither in the overall population (overall population adjusted hazard rate ratio (HR(adj)): 0.80 [95% CI: 0.59-1.08]), nor when stratified by randomization arm (pharmaceutical care HR(adj): 0.77 [95% CI: 0.49-1.23]); usual care HR(adj): 0.81 [95% CI: 0.54-1.21]). The median medication possession ratio was significantly lower in users of phytosterols/-stanols in the usual care group, but the difference was not clinically relevant. Conclusions Customary use of phytosterol/-stanol-enriched functional foods did not affect adherence to statins in new users that are well informed on the beneficial effects of statin therapy. In daily medical practice, general practitioners and pharmacists should urge subjects not to take phytosterol/-stanol-enriched functional foods as replacement for their prescribed medication. Copyright (C) 2011 John Wiley & Sons, Ltd

Predictive Performance of Cardiovascular Disease Risk Prediction Algorithms in People Living With HIV

Immunogenetics and cellular immunology of bacterial infectious disease