Highlighting the clinical need for diagnosing Mycoplasma genitalium infection.

Despite Mycoplasma genitalium (MG) being increasingly recognised as a genital pathogen in men and women, awareness and utility of commercially available MG-testing has been low. The opinion of UK sexual health clinicians and allied professionals was sought on how MG-testing should be used. Thirty-two consensus statements were developed by an expert group and circulated to clinicians and laboratory staff, who were asked to evaluate their level of agreement with each statement; 75% agreement was set as the threshold for defining consensus for each statement. A modified Delphi approach was used and high levels of agreement obviated the need to test the original statement set further. Of 201 individuals who received questionnaires, 60 responded, most (48) being sexual health consultants, more than 10% of the total in the UK. Twenty-seven (84.4%) of the statements exceeded the 75% threshold. Respondents strongly supported MG-testing of patients with urethritis, pelvic inflammatory disease or unexplained persistent vaginal discharge, or post-coital bleeding. Fewer favoured testing patients with proctitis and support was divided for routinely testing Chlamydia-positive patients. Testing of current sexual contacts of MG-positive patients was supported, as was a test of cure for MG-positive patients, although agreement fell below the 75% threshold. Respondents agreed that all consultant- or specialist-led services should have access to testing for MG (98.3%). There was strong agreement for having MG-testing available for specific patient groups, which may reflect concern over antibiotic resistance and the desire to comply with clinical guidelines that recommend MG-testing in sexual health clinic settings

Modernizing clinical trial eligibility criteria: Recommendations of the ASCO-Friends of Cancer Research Prior Therapies Work Group

PURPOSE: Restrictive eligibility criteria induce differences between clinical trial and real-world treatment populations. Restrictions based on prior therapies are common; minimizing them when appropriate may increase patient participation in clinical trials. EXPERIMENTAL DESIGN: A multi-stakeholder working group developed a conceptual framework to guide evaluation of prevailing practices with respect to using prior treatment as selection criteria for clinical trials. The working group made recommendations to minimize restrictions based on prior therapies within the boundaries of scientific validity, patient centeredness, distributive justice, and beneficence. RECOMMENDATIONS: (i) Patients are eligible for clinical trials regardless of the number or type of prior therapies and without requiring a specific therapy prior to enrollment unless a scientific or clinically based rationale is provided as justification. (ii) Prior therapy (either limits on number and type of prior therapies or requirements for specific therapies before enrollment) could be used to determine eligibility in the following cases: a) the agents being studied target a specific mechanism or pathway that could potentially interact with a prior therapy; b) the study design requires that all patients begin protocol-specified treatment at the same point in the disease trajectory; and c) in randomized clinical studies, if the therapy in the control arm is not appropriate for the patient due to previous therapies received. (iii) Trial designers should consider conducting evaluation separately from the primary endpoint analysis for participants who have received prior therapies. CONCLUSIONS: Clinical trial sponsors and regulators should thoughtfully reexamine the use of prior therapy exposure as selection criteria to maximize clinical trial participation

Impact of traffic congestion on road accidents : a spatial analysis of the M25 motorway in England

Traffic congestion and road accidents are two external costs of transport and the reduction of their impacts is often one of the primary objectives for transport policy makers. The relationship between traffic congestion and road accidents however is not apparent and less studied. It is speculated that there may be an inverse relationship between traffic congestion and road accidents, and as such this poses a potential dilemma for transport policy makers. This study aims to explore the impact of traffic congestion on the frequency of road accidents using a spatial analysis approach, while controlling for other relevant factors that may affect road accidents. The M25 London orbital motorway, divided into 70 segments, was chosen to conduct this study and relevant data on road accidents, traffic and road characteristics were collected. A robust technique has been developed to map M25 accidents onto its segments. Since existing studies have often used a proxy to measure the level of congestion, this study has employed a precise congestion measurement. A series of Poisson based non-spatial (such as Poisson-lognormal and Poisson-gamma) and spatial (Poisson-lognormal with conditional autoregressive priors) models have been used to account for the effects of both heterogeneity and spatial correlation. The results suggest that traffic congestion has little or no impact on the frequency of road accidents on the M25 motorway. All other relevant factors have provided results consistent with existing studies