ABSTRACT: Evidence-based Medicine (EbM) was originally developed as a teaching tool for young doctors, but in Germany the last surveys among residents in 2009 and 2011 demonstrated that, across all topics, the largest deficits were seen in the field of EbM. One reason may be a deficit in customised offers for continuing medical education in EbM. In a randomised controlled trial with a wait-control design we investigated a possible gain in knowledge and the acceptance of an online course in EbM for first-year residents.
All first-year residents at the Hospital of the Goethe University in Frankfurt received the offer to voluntarily take part in an online EbM course. The tutored course consisted of five modules according to the five steps of EbM, each module being complemented by practical tasks. The participants were randomised via telephone to the course right away or after a three-month waiting period. The primary endpoint (i.e., knowledge) was tested via two sets of 13 multiple choice questions before and after the course and after 6 and 12 months. The participants were asked to subjectively evaluate the course by using an A-F grading system and to semiquantitatively assess its level of difficulty; they were also asked to evaluate the usefulness of its content in their clinical setting.
114 out of the 120 randomised participants took part. After 3 months the immediate intervention group (n=58) achieved a median of 10 (95 % confidence interval 10 to 11) correct answers following the course, whereas the waiting intervention group only received a median of 4 (95% confidence interval 4 to 5) correct answers after the three month waiting period (p ≤ 0.0001). The median gain in knowledge for both groups throughout the course was 5 correct answers (p ≤ 0.0001), and this proved to remain constant within a twelve month period. Six months after the course, this course was rated as clinically useful by 96.4 % of the participants, and 38.1% stated that they would volunteer again in further teaching activities. The course received a median grade of B.
A German online EbM course for first-year residents leads to a remarkable and sustainable gain in knowledge, is well marked, and its contents were regarded as clinically relevant. This tutored practical course is applicable to various settings and could provide an important contribution to EbM residency programs.
Zeitschrift für Evidenz, Fortbildung und Qualität im Gesundheitswesen. 01/2013; 107(1):36-43.
ABSTRACT: Consumers increasingly demand to take part in healthcare decisions as described by the concept of shared decision making. In order to ensure this happens the patient must be able to critically appraise the healthcare information provided, which is called critical health literacy. Critical health literacy can be taught to patients at the onset of their disease to enable them to obtain information about interventions and alternatives. For the primary prevention of common diseases like hypertension or diabetes mellitus, though, it is necessary to empower consumers to critically appraise medical information since this information is routinely presented in the mass media. This might be achieved through educational intervention programmes at school.
The study was designed as a prospective controlled trial with students in training to become biology teachers at Siegen University (Germany). The intervention group received a short-term educational intervention (24 units) in human biology based on the principles of Evidence-based Medicine (EbM) and Good Scientific Practice (GSP) combined with elements of problem-based learning. The control group received a short-term intervention in human biology of equal duration, but without the elements of EbM and GSP. Knowledge and skills were evaluated by validated questionnaires and case studies in a pre-, interim, and post-interventional test in both groups. In addition, biology trainee teachers in the intervention group also planned and conducted a one-hour problem-based learning session with high school students, which was evaluated by video.
The increase in knowledge (7.9±3.8 points vs. 2.7±2.5 points, p≤0.001) and appraisal skills (24.1±6.7 points vs. 14.6±6.3, p≤0.001) after the intervention was relevant and significant compared to baseline results and also compared to the control group that did not show any significant progress in knowledge (3.9±2.4 points vs. 2.7±1.7) and appraisal skills (16.2±5.9 points vs. 14.4±5.6). All the participants in the intervention group passed both the preparation and the conduction of their problem-based learning session with high school students with at least 50 % of the maximum number of points. Satisfaction among students in training to become biology teachers (median grade of 2 [good] in the German grading system) and students (89 % of students agreed this to be an interesting method) were high in the intervention group.
This preliminary study showed a relevant increase in knowledge about EbM and skills in critically appraising interventional studies. Participating students were able to conduct problem-based learning sessions for high school students about the principles of EbM and GSP. The results justify a larger randomised controlled trial to evaluate both effects and applicability to different school settings.
Zeitschrift für Evidenz, Fortbildung und Qualität im Gesundheitswesen. 01/2013; 107(1):53-61.
ABSTRACT: Mycosis fungoides is the most common type of cutaneous T-cell lymphoma, a malignant, chronic disease initially affecting the skin. Several therapies are available, which may induce clinical remission for a time.
To assess the effects of interventions for mycosis fungoides in all stages of the disease.
We searched the following databases up to January 2011: the Cochrane Skin Group Specialised Register, CENTRAL in The Cochrane Library, MEDLINE (from 2005), EMBASE (from 2010), and LILACS (from 1982). We also checked reference lists of included studies for further references to relevant RCTs. We searched online trials registries for further references to unpublished trials and undertook a separate search for adverse effects of interventions for mycosis fungoides in non-RCTs in MEDLINE in May 2011.
Randomised controlled trials (RCTs) of interventions for mycosis fungoides in people with any stage of the disease. At least 90% of participants in the trials must have been diagnosed with mycosis fungoides (Alibert-Bazin-type).
Two authors independently assessed eligibility and methodological quality for each study and carried out data extraction. We resolved any disagreement by discussion. Primary outcomes were the impact on quality of life and the safety of interventions. When available, we reported on our secondary outcomes, which were the improvement or clearance of skin lesions, disease-free intervals, survival rates, relapse rates, and rare adverse effects. When possible, we combined homogeneous studies for meta-analysis. We used The Cochrane Collaboration's 'Risk of bias' tool to assess the internal validity of all included studies in six different domains.
The review included 14 RCTs involving 675 participants, covering a wide range of interventions. Eleven of the included trials assessed participants in clinical stages IA to IIB only (please see Table 1 for definitions of these stages).Internal validity was considerably low in studies with a high or unclear risk of bias. The main reasons for this were low methodological quality or missing data, even after we contacted the study authors, and a mean dropout rate of 26% (0% to 72%). Study size was generally small with a minimum of 4 and a maximum of 103 participants. Only one study provided a long enough follow-up for reliable survival analysis.Included studies assessed topical treatments, such as imiquimod, peldesine, hypericin, nitrogen mustard, as well as intralesional injections of interferon-α (IFN-α). The light therapies investigated included psoralen plus ultraviolet A light (PUVA), extracorporeal photopheresis (photochemotherapy), and visible light. Oral treatments included acitretin, bexarotene, and methotrexate. Treatment with parenteral systemic agents consisted of denileukin diftitox; a combination of chemotherapy and electron beam radiation; and intramuscular injections of active transfer factor. Nine studies evaluated therapies by using an active comparator; five were placebo-controlled RCTs.Twelve studies reported on common adverse effects, while only two assessed quality of life. None of these studies compared the health-related quality of life of participants undergoing different treatments. Most of the reported adverse effects were attributed to the interventions. Systemic treatments, and here in particular a combined therapeutic regimen of chemotherapy and electron beam, bexarotene, or denileukin diftitox, showed more adverse effects than topical or skin-directed treatments.In the included studies, clearance rates ranged from 0% to 83%, and improvement ranged from 0% to 88%. The meta-analysis combining the results of 2 trials comparing the effect of IFN-α and PUVA versus PUVA alone showed no significant difference in the relative risk of clearance: 1.07 (95% confidence interval 0.87 to 1.31). None of the included studies demonstrated a significant increase in disease-free intervals, relapse, or overall survival.
This review identified trial evidence for a range of different topical and systemic interventions for mycosis fungoides. Because of substantial heterogeneity in design, small sample sizes, and low methodological quality, the comparative safety and efficacy of these interventions cannot be established on the basis of the included RCTs. Taking into account the possible serious adverse effects and the limited availability of efficacy data, topical and skin-directed treatments are recommended first, especially in the early stages of disease. More aggressive therapeutic regimens may show improvement or clearance of lesions, but they also result in more adverse effects; therefore, they are to be considered with caution. Larger studies with comparable, clearly-defined end points for all stages of mycosis fungoides, and a focus on safety, quality of life, and duration of remission as part of the outcome measures, are necessary.
Cochrane database of systematic reviews (Online) 01/2012; 9:CD008946. · 5.72 Impact Factor
ABSTRACT: The incidence of ischemia might be increased in the surgical repair of atherosclerotic unruptured aneurysms compared to non-atherosclerotic aneurysms. The atherosclerotic wall might increase the occurrence of thrombembolic events or its rigidity might endanger the occlusion of perforators within the aneurysm vicinity.
87 patients (53 patients without and 34 patients with atherosclerotic unruptured aneurysms, 50.5 ± 9.7 years) were analyzed for severity of atherosclerosis within the aneurysm and the aneurysm bearing vessel, surgical maneuvers, intraoperative alterations in evoked potentials and clinical and neuroradiological results.
Temporary vessel occlusion (25% vs. 50%, p = 0.021), repositioning of a permanent clip (21% vs. 56%, p = 0.001) and aneurysm remnants (2% vs. 18%, p = 0.012) occurred more often in patients with atherosclerotic aneurysms. At 6 months, 3/34 patients with atherosclerosis (8.8%) had an unfavorable outcome, all patients without atherosclerosis had a favorable outcome (p = 0.056).
The surgical repair of unruptured aneurysms is safe but patients with atherosclerotic altered vessels and aneurysms accounted to a minor increase in unfavorable outcome and an increased risk of morbidity at 6 months postoperatively. This factor should be taken into consideration when performing surgery of atherosclerotic, unruptured aneurysms.
Clinical neurology and neurosurgery 02/2011; 113(2):129-35. · 1.30 Impact Factor
ABSTRACT: All major guidelines for antihypertensive therapy recommend weight loss. Thus dietary interventions that aim to reduce body weight might be a useful intervention to reduce blood pressure and adverse cardiovascular events associated with hypertension.
Primary objectivesTo assess the long-term effects of weight-reducing diets in hypertensive patients on- all cause mortality - cardiovascular morbidity - adverse events (including total serious adverse events, withdrawal due to adverse events and total non-serious adverse events)Secondary objectivesTo assess the long-term effects of weight-reducing diets in hypertensive patients on- change from baseline in systolic blood pressure - change from baseline in diastolic blood pressure - body weight reduction
Studies were obtained from computerised searches of Ovid MEDLINE, EMBASE, CENTRAL and from searches in reference lists and systematic reviews.
Randomised controlled trials (RCT) in adult hypertensive patients were included if they had a study duration of at least 24 weeks and compared weight reducing dietary interventions to no dietary intervention in adult patients with primary hypertension.
Two authors independently assessed risk of bias and extracted data. Studies were pooled using fixed-effect meta-analysis. In case of moderate or larger heterogeneity as measured by Higgins I(2), a random effects model was used.
Eight studies involving a total of 2100 participants with high blood pressure and a mean age of 45 to 66 years met our inclusion criteria. Mean treatment duration was 6 to 36 months. No study included mortality as a pre-defined outcome. One RCT evaluated the effects of dietary weight loss on a combined endpoint, consisting of the necessity of reinstating antihypertensive therapy and severe cardiovascular complications. In this RCT weight reducing diet lowered the endpoint, hazard ratio 0.70 (95% confidence interval [CI], 0.57 to 0.87) compared to no diet. None of the studies evaluated adverse events as designated in our protocol. Blood pressure was reduced in patients assigned to weight loss diets as compared to controls: systolic blood pressure (SBP): weighted mean difference (WMD): -4.5 mm Hg; 95% CI, -7.2 to -1.8 mm Hg (3 of 8 studies included in analysis), and diastolic blood pressure (DBP): WMD -3.2 mm Hg; 95% CI, -4.8 to -1.5 mm Hg (3 of 8 studies included in analysis). Patients' body weight was also reduced in dietary weight loss groups as compared to controls, WMD of -4.0 kg (95% CI: -4.8 to -3.2) (5 of 8 studies included in analysis). Two studies used withdrawal of antihypertensive medication as their primary outcome. Even though this was not considered a relevant outcome for this review, the results of these studies strengthen the finding of reduction of blood pressure by dietary weight loss interventions.
In patients with primary hypertension, weight loss diets reduced body weight and blood pressure, however the magnitude of the effects are uncertain as a result of the small number of patients and studies that could be included in the analyses. It is not known whether weight loss reduces mortality and morbidity. No useful information on adverse effects was reported in the relevant trials.
Cochrane database of systematic reviews (Online) 01/2011; · 5.72 Impact Factor
ABSTRACT: To evaluate the effect of a compulsory evidence-based medicine (EBM) seminar in critical appraisal skills and the overall acceptance of compulsory EBM seminars for Year 3 medical undergraduate students.
Small group seminars by peer teaching were conducted for up to 23 undergraduates. Knowledge and skills in EBM before and after the compulsory seminars were evaluated by 2 different sets of 20 questions. To apply knowledge, each undergraduate had to analyse an individual paper case using the principles of EBM. Undergraduates gave anonymous feedback using separate evaluation sheets at the end of the seminar. Main outcome variables were changes in knowledge and skills.
A total of 132 Year 3 undergraduates at the University of Frankfurt participated in a compulsory EBM seminar during the academic half-year 2003/04 as part of their regular curriculum. Complete datasets were available for evaluation from 124 undergraduates (94%). The seminars led to an overall increase in knowledge (question paper score increase from 2.37 to 7.48, 99% CI 6.61-8.36, or 216%). Transfer of knowledge into a paper case scenario was generally good, with a mean score of 49.5 (SD 5.24) out of 55 points. Feedback indicated good overall acceptance of the seminars, with a median of 2 (score range from 1 = excellent to 6 = failed).
Trained medical students are effective and well accepted EBM trainers in compulsory undergraduate seminars.
Medical Education 08/2005; 39(7):665-71. · 3.18 Impact Factor