A comprehensive BAV phenotype includes aortic shape. Type 1 BAV is associated with male gender and normal aortic shape but a larger sinus diameter. Type 2 leaflet morphology is associated with ascending aorta dilatation , larger arch dimensions and higher prevalence of myxomatous mitral valve disease.

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ObjectivesThe aim of this Delphi survey was to establish an international consensus on the most useful outcome measures for research on the effectiveness of non-pharmacological interventions for migraine. This is important, since guidelines for pharmacological trials recommend measuring the frequency of headaches with 50% reduction considered a clinically meaningful effect. It is unclear whether the same recommendations apply to complementary (or adjunct) non-pharmacological approaches, whether the same cut-off levels need to be considered for effectiveness when used as an adjunct or stand-alone intervention, and what is meaningful to patients.SettingUniversity-initiated international survey.ParticipantsThe expert panel was chosen based on publications on non-pharmacological interventions in migraine populations and from personal contacts. 35 eligible researchers were contacted, 12 agreed to participate and 10 completed all 3 rounds of the survey. To further explore how migraine patients viewed potential outcome measures, four migraine patients were interviewed and presented with the same measurement tools as the researchers.ProceduresThe initial Delphi round was based on a systematic search of the literature for outcome measures used in non-pharmacological interventions for headache. Suggested outcome measures were rated by each expert, blinded towards the other members of the panel, for its usefulness on a 5-point Likert scale ranging from definitely not useful to extremely useful. Results were combined using median values and IQRs. Tools rated overall as definitely or probably not useful were excluded from subsequent rounds. Experts further suggested additional outcome measures that were presented to the panel in subsequent rounds. Additionally, experts were asked to rank the most useful tools and provide information on feasible cut-off levels for effectiveness for the three highest ranked tools.ResultsResults suggest the use of the Migraine Disability Assessment (MIDAS), Headache Impact Test (HIT-6) and headache frequency as primary outcome measures. Patient experts suggested the inclusion of a measure of quality of life and evaluation of associated symptoms and fear of attacks.ConclusionsRecommendations are for the use of the MIDAS, the HIT-6 and headache frequency, in combination with an outcome measure for quality of life. Associated symptoms and fear of attacks should also be considered as secondary outcomes, if relevant for the individual target population. The cut-off level for effectiveness should be lower for non-pharmacological interventions, especially when used as an adjunct to medication.Trial registration numberGerman Register of Clinical Trials (DRKS00011777)

Prior to 1993, most drug efficacy and safety trials were conducted in white males, although gender and racial differences in pharmacodynamics and pharmacokinetics have been documented since the early 1900s. Over the last 2 decades, supported by the FDA and legislation, attempts to include more women and minorities in clinical drug trials have been made, with limited success. Yet, there are important differences in pathophysiology and pharmacogenetics, as well as pharmacotherapeutic effectiveness. This is the first of 2 articles that review the basic scientific principles of such differences. In particular, genetic polymorphisms of cardiovascular candidate genes and drug metabolism are described. The pharmacodynamic and pharmacokinetic variations among genders and ethnicities are summarized.

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Women are underrepresented in clinical trials. Lower doses of beta-blockers are required for Southeast Asians. ACE and ARB's are teratogenic in the second trimester. Torsades de Pointes is more common in women related to a longer QT-interval. Lower dose OCPs decrease the risk of MI, stroke and thrombosis. HRTs are not effective for CAD prevention.

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BackgroundWhile several methods are used to measure thermodilution (TD) cardiac index (CI), most catheterization laboratories use proprietary systems that have not been recently validated. Because cardiac rejection may present with decreased CI, heart transplant recipients routinely undergo hemodynamic assessment, making accurate CI assessment essential in these patients.MethodsAs a quality improvement initiative, we measured CI in 39 stable heart transplant recipients without tricuspid regurgitation by one or more of three different TD methods: with the injectate temperature probe in the water bath through which the injectate was drawn (“open” systems) at room temperature (“RT,” n = 26) or iced (“Iced,” n = 13) or with direct injectate temperature measurement (“Inline,” n = 14). As a control, Fick CI (with assumed O2 consumption) was measured in all patients. Standard nonparametric tests were used for comparison.ResultsFick CI was overestimated by each TD method by median (interquartile range) values of 36% (21-61%) for Open-Iced (p = .0012), 26% (14-39%) for Open-RT (p < .0001), and 11% (0-18%) for Inline-Iced (p = .002). Correlation with Fick-CI was better for Inline-Iced CI (r = .79) and poorer for Open-RT CI (r = .56) and Open-Iced CI (r = .61). Among the TD methods, there were significant differences between median Inline-Iced CI values and those for either the Open-Iced (p = .017) or Open-RT (p = .0005) methods.ConclusionsAs compared to Fick, each TD method significantly overestimated CI in stable patients, often to an extent that may be clinically relevant. This was especially true if the injectate temperature was measured with an “open” system.