Background: To preserve quality and continuity of care, collaboration between primary-care and secondary-care physicians is becoming increasingly important. Therefore, learning intraprofessional... Show moreBackground: To preserve quality and continuity of care, collaboration between primary-care and secondary-care physicians is becoming increasingly important. Therefore, learning intraprofessional collaboration (intraPC) requires explicit attention during postgraduate training. Hospital placements provide opportunities for intraPC learning, but these opportunities require interventions to support and enhance such learning. Design-Principles guide the design and development of educational activities when theory-driven Design-Principles are tailored into context-sensitive Design-Principles. The aim of this study was to develop and substantiate a set of theory-driven and context-sensitive Design-Principles for intraPC learning during hospital placements. Methods: Based on our earlier research, we formulated nine theory-driven Design-Principles. To enrich, refine and consolidate these principles, three focus group sessions with stakeholders were conducted using a Modified Nominal Group Technique. Next, two work conferences were conducted to test the feasibility and applicability of the Design-Principles for developing intraPC educational activities and to sharpen the principles into a final set of Design-Principles. Results: The theoretical Design-Principles were discussed and modified iteratively. Two new Design-Principles were added during focus group 1, and one more Design-Principle was added during focus group 2. The Design-Principles were categorised into three clusters: (i) Culture: building collaborative relations in a psychologically safe context where patterns or feelings of power dynamics between primary and secondary care physicians can be discussed; (ii) Connecting Contexts: making residents and supervisors mutually understand each other's work contexts and activities; and (iii) Making the Implicit Explicit: having supervising teams act as role models demonstrating intraPC and continuously pursuing improvement in intraPC to make intraPC explicit. Participants were unanimous in their view that the Design-Principles in the Culture cluster were prerequisites to facilitate intraPC learning. Conclusion: This study led to the development of 12 theory-driven and context-sensitive Design-Principles that may guide the design of educational activities to support intraPC learning during hospital placements. Show less
Atherosclerosis - the pathophysiological mechanism shared by most cardiovascular diseases - can be directly or indirectly assessed by a variety of clinical tests including measurement of carotid... Show moreAtherosclerosis - the pathophysiological mechanism shared by most cardiovascular diseases - can be directly or indirectly assessed by a variety of clinical tests including measurement of carotid intima-media thickness, carotid plaque, ankle-brachial index, pulse wave velocity, and coronary artery calcium. The Prospective Studies of Atherosclerosis (Proof-ATHERO) consortium (https://clinicalepi.i-med.ac.at/research/proof-athero/) collates de-identified individual-participant data of studies with information on atherosclerosis measures, risk factors for cardiovascular disease, and incidence of cardiovascular diseases. It currently comprises 74 studies that involve 106,846 participants from 25 countries and over 40 cities. In summary, 21 studies recruited participants from the general population (n = 67,784), 16 from high-risk populations (n = 22,677), and 37 as part of clinical trials (n = 16,385). Baseline years of contributing studies range from April 1980 to July 2014; the latest follow-up was until June 2019. Mean age at baseline was 59 years (standard deviation: 10) and 50% were female. Over a total of 830,619 person-years of follow-up, 17,270 incident cardiovascular events (including coronary heart disease and stroke) and 13,270 deaths were recorded, corresponding to cumulative incidences of 2.1% and 1.6% per annum, respectively. The consortium is coordinated by the Clinical Epidemiology Team at the Medical University of Innsbruck, Austria. Contributing studies undergo a detailed data cleaning and harmonisation procedure before being incorporated in the Proof-ATHERO central database. Statistical analyses are being conducted according to pre-defined analysis plans and use established methods for individual-participant data meta-analysis. Capitalising on its large sample size, the multi-institutional collaborative Proof-ATHERO consortium aims to better characterise, understand, and predict the development of atherosclerosis and its clinical consequences. (c) 2020 S. Karger AG, Basel Show less
Background: To quantify the association between effects of interventions on carotid intima-media thickness (cIMT) progression and their effects on cardiovascular disease (CVD) risk. Methods: We... Show moreBackground: To quantify the association between effects of interventions on carotid intima-media thickness (cIMT) progression and their effects on cardiovascular disease (CVD) risk. Methods: We systematically collated data from randomized, controlled trials. cIMT was assessed as the mean value at the common-carotid-artery; if unavailable, the maximum value at the common-carotid-artery or other cIMT measures were used. The primary outcome was a combined CVD end point defined as myocardial infarction, stroke, revascularization procedures, or fatal CVD. We estimated intervention effects on cIMT progression and incident CVD for each trial, before relating the 2 using a Bayesian meta-regression approach. Results: We analyzed data of 119 randomized, controlled trials involving 100 667 patients (mean age 62 years, 42% female). Over an average follow-up of 3.7 years, 12 038 patients developed the combined CVD end point. Across all interventions, each 10 mu m/y reduction of cIMT progression resulted in a relative risk for CVD of 0.91 (95% Credible Interval, 0.87-0.94), with an additional relative risk for CVD of 0.92 (0.87-0.97) being achieved independent of cIMT progression. Taken together, we estimated that interventions reducing cIMT progression by 10, 20, 30, or 40 mu m/y would yield relative risks of 0.84 (0.75-0.93), 0.76 (0.67-0.85), 0.69 (0.59-0.79), or 0.63 (0.52-0.74), respectively. Results were similar when grouping trials by type of intervention, time of conduct, time to ultrasound follow-up, availability of individual-participant data, primary versus secondary prevention trials, type of cIMT measurement, and proportion of female patients. Conclusions: The extent of intervention effects on cIMT progression predicted the degree of CVD risk reduction. This provides a missing link supporting the usefulness of cIMT progression as a surrogate marker for CVD risk in clinical trials. Show less
Bovendeerd, B.; Jong, K. de; Colijn, S.; Groot, E. de; Hafkenscheid, A.; Moerbeek, M.; Keijser, J. de 2019
Introduction The Partners for Change Outcome Management System (PCOMS) is a client feedback-system built on two brief visual analogue self-report scales. Prior studies of PCOMS have found effects... Show moreIntroduction The Partners for Change Outcome Management System (PCOMS) is a client feedback-system built on two brief visual analogue self-report scales. Prior studies of PCOMS have found effects varying from significant positive to negative. Aims of present study are; to test the predicted beneficial impact of PCOMS, while accounting for methodological flaws in prior studies and to clarify under which circumstances the addition of PCOMS to therapy has a beneficial effect.Methods and analysis This study focuses on patients applying for brief, time-limited treatments. Four centres will be randomised to either treatment as usual (TAU) or TAU with PCOMS. All participating patients will be assessed four times. The full staff in the experimental condition will be trained in PCOMS. In the second part of this study, all therapists in the PCOMS condition will fill in a questionnaire concerning the influence of regulatory focus, self-efficacy, external or internal feedback orientation and perceived feedback validity of PCOMS. Finally, patients in the PCOMS condition will be asked to give feedback through a structured interview.The primary outcome measure is the Outcome Questionnaire over the period from beginning to end of therapy. The Mental Health Continuum-Short Form and Consumer Quality Index are also completed. In the primary analysis, outcomes of the two treatment conditions on treatment outcome, patient satisfaction, costs, drop-out and duration will be examined with a three-level (within patient, between patients and between therapists) multilevel analysis. The DSM-classification, sex, education level, age of each patient and therapist factors will be included as covariates.Ethics and dissemination The Medical Ethics Committee of the University of Twente approved this study (K15-11, METC Twente). Data will be included from 1 January 2016 to 1 July 2019. Study results will be disseminated through peer-reviewed journals and conferences.Trial registration number NTR5466; Pre-results. Show less
Aim: To evaluate if, one year after notification of possible overtreatment, diabetes care providers de-intensified glucose-lowering medications and to gain insight into the opinions and beliefs of... Show moreAim: To evaluate if, one year after notification of possible overtreatment, diabetes care providers de-intensified glucose-lowering medications and to gain insight into the opinions and beliefs of both care providers and patients regarding de-intensification.Methods: Mixed methods using routine care data from five health-care centres in the Netherlands. Patient characteristics and medication prescription of patients, previously identified as possibly over-treated, were extracted from patients' medical records. Opinions of care providers were obtained through interviews. Patients received questionnaires about their diabetes treatment and were asked to participate in focus groups.Results: A total of 64 elderly patients with type 2 diabetes were previously identified as possibly over-treated and included; 57.8% male, median age 75 years (IQR=72-82), median diabetes duration 12 years (IQR=8-18). De-intensification was implemented in more than half (n=36) of them. Care providers preferred person-centred care above just setting general HbA1c target values, considering patient characteristics (such as comorbidity) and patient's preference. Patients valued glucose levels as most important in determining their treatment. Both patients and care providers felt that de-intensification should occur gradually.Conclusion: Treatment had been de-intensified in more than half of the patients (56.3%). Insight in reasons for not de-intensifying elderly patients is important since treatment for them can be "person-centred care". De-intensification is an iterative and time-intensive process. Show less
Bakker, R.; Mens, J.W.; Groot, E. de; Tuijnman-Raasveld, C.; Braat, C.; Hompus, W.; ... ; Kuile, M. ter 2016
Dalcetrapib increases high-density lipoprotein cholesterol (HDL-C) levels through effects on cholesteryl ester transfer protein (CETP). As part of the dalcetrapib dal-HEART clinical trial programme... Show moreDalcetrapib increases high-density lipoprotein cholesterol (HDL-C) levels through effects on cholesteryl ester transfer protein (CETP). As part of the dalcetrapib dal-HEART clinical trial programme, the efficacy and safety of dalcetrapib is assessed in coronary heart disease (CHD) patients in the dal-VESSEL study (ClinicalTrials.gov identifier: NCT00655538), the design and methods of which are presented here. Men and women with CHD or CHD risk equivalent, with HDL-C levels < 50 mg/dL were recruited for a 36-week, double-blinded, placebo-controlled trial. After a pre-randomisation phase of up to 8 weeks, patients received dalcetrapib 600 mg/day or placebo in addition to their existing treatments. Brachial flow-mediated dilatation (FMD) measured by B-mode ultrasound represents endothelial function and is a validated marker for early atherosclerosis and cardiovascular disease risk. The primary efficacy outcome is change from baseline in brachial FMD after 12 weeks. The primary safety endpoint is 24-hour ambulatory blood pressure monitoring (ABPM) assessed at week 4. Secondary endpoints include brachial FMD at 36 weeks, ABPM at 12 and 36 weeks, lipid profile, CETP mass and activity, and markers of inflammation, oxidation, and cardiovascular risk. Clinical endpoints are assessed as a composite endpoint for the dal-HEART Program. In 19 European clinical centres, 476 subjects met inclusion criteria and have entered the study. In conclusion, the dal-VESSEL study is the largest multicentre trial with brachial FMD ever performed. The study assesses efficacy and safety of dalcetrapib on endothelial function, blood pressure, lipids, and clinical outcomes in CHD patients with below average HDL-C and will therefore provide vital information regarding its potential role in the preventative treatment of CHD risk. Show less
