Investigator experiences with financial conflicts of interest in clinical trials

<p>Abstract</p> <p>Background</p> <p>Financial conflicts of interest (fCOI) can introduce actions that bias clinical trial results and reduce their objectivity. We obtained information from investigators about adherence to practices that minimize the introduction of such bias in their clinical trials experience.</p> <p>Methods</p> <p>Email survey of clinical trial investigators from Canadian sites to learn about adherence to practices that help maintain research independence across all stages of trial preparation, conduct, and dissemination. The main outcome was the proportion of investigators that reported full adherence to preferred trial practices for all of their trials conducted from 2001-2006, stratified by funding source.</p> <p>Results</p> <p>844 investigators responded (76%) and 732 (66%) provided useful information. Full adherence to preferred clinical trial practices was highest for institutional review of signed contracts and budgets (82% and 75% of investigators respectively). Lower rates of full adherence were reported for the other two practices in the trial preparation stage (avoidance of confidentiality clauses, 12%; trial registration after 2005, 39%). Lower rates of full adherence were reported for 7 practices in the trial conduct (35% to 43%) and dissemination (53% to 64%) stages, particularly in industry funded trials. 269 investigators personally experienced (n = 85) or witnessed (n = 236) a fCOI; over 70% of these situations related to industry trials.</p> <p>Conclusion</p> <p>Full adherence to practices designed to promote the objectivity of research varied across trial stages and was low overall, particularly for industry funded trials.</p

Is medial calcar continuity necessary in plate osteosynthesis for proximal humerus fractures?

WOS: 000427371000018PubMed: 29519987Objective: To evaluate the functional and radiological results of patients with and without medial calcar continuity in plate osteosynthesis applied for a proximal humerus fracture retrospectively. Methods: The study included 27 patients to whom plate osteosynthesis was applied because of a proximal humerus fracture between January 2, 2010, and December 30, 2013, at Okmeydani Research and Training Hospital. Patients were separated into Group A with medial calcar continuity and Group B without medial calcar continuity. On the radiographs taken postoperatively and at the final follow-up examination, measurements were taken of the humeral head height and the humeral neck-shaft angle. The presence of avascular necrosis was recorded. Results: The functional and radiological results of the patients were evaluated after a mean follow-up of 39.1 months. No statistically significant difference was determined between Groups A and B in respect of the postoperative and the final follow-up humeral head height (P > 0.05). No statistically significant difference was determined between Groups A and B in respect of the postoperative and the final follow-up humeral neck-shaft angle (P > 0.05). Plate breakage was seen in one patient without medial calcar continuity. Penetration of the screw into the joint was determined in one patient in Group A and three patients in Group B. No avascular necrosis or infection was seen in any patient. Conclusion: When the surgical process has not damaged the soft tissue and sufficient stability has been achieved, providing calcar continuity is not an absolute condition

The Effect of Computerized Physician Order Entry with Clinical Decision Support on the Rates of Adverse Drug Events: A Systematic Review

CONTEXT: Computerized physician order entry (CPOE) with clinical decision support (CDS) has been promoted as an effective strategy to prevent the development of a drug injury defined as an adverse drug event (ADE). OBJECTIVE: To systematically review studies evaluating the effects of CPOE with CDS on the development of an ADE as an outcome measure. DATA SOURCES: PUBMED versions of MEDLINE (from inception through March 2007) were searched to identify relevant studies. Reference lists of included studies were also searched. METHODS: We searched for original investigations, randomized and nonrandomized clinical trials, and observational studies that evaluated the effect of CPOE with CDS on the rates of ADEs. The studies identified were assessed to determine the type of computer system used, drug categories being evaluated, types of ADEs measured, and clinical outcomes assessed. RESULTS: Of the 543 citations identified, 10 studies met our inclusion criteria. These studies were grouped into categories based on their setting: hospital or ambulatory; no studies related to the long-term care setting were identified. CPOE with CDS contributed to a statistically significant (P \u3c or = .05) decrease in ADEs in 5 (50.0%) of the 10 studies. Four studies (40.0%) reported a nonstatistically significant reduction in ADE rates, and 1 study (10.0%) demonstrated no change in ADE rates. CONCLUSIONS: Few studies have measured the effect of CPOE with CDS on the rates of ADEs, and none were randomized controlled trials. Further research is needed to evaluate the efficacy of CPOE with CDS across the various clinical settings