Bipolar radiofrequency compared with thermal balloon ablation in the office: a randomized controlled trial.

OBJECTIVE: To estimate the effectiveness of office-based bipolar radiofrequency ablation compared with thermal balloon ablation of the endometrium for the treatment of heavy menstrual bleeding at 5-year follow-up. METHODS: A single blind randomized controlled trial was conducted in an office hysteroscopy clinic in a university teaching hospital. A total of 81 women were randomly allocated to either bipolar radiofrequency ablation or thermal balloon ablation in an office setting avoiding use of general anesthesia or conscious sedation. The primary outcome for the trial was amenorrhea at 6 months follow-up. In this planned secondary analysis, the main outcome measures were amenorrhea rates, patient satisfaction, health-related quality of life, and incidence of further uterine surgery at 5-year follow-up. RESULTS: At 5-year follow-up, 59 (73%) women responded to postal questionnaires. Amenorrhea was reported in 60% of thermal balloon ablation and 62% of bipolar radiofrequency ablation (odds ratio [OR] 1.09 [0.38-3.11]) and satisfaction with treatment outcome in 96% of thermal balloon ablation and 96% of bipolar radiofrequency ablation (OR 0.92 [0.05-25.59]). Further surgical intervention was needed in three of 29 (10%) women treated with bipolar radiofrequency ablation compared with four of 30 (13%) of women treated with thermal balloon ablation (P=.7). There was no significant difference in either condition-specific or generic health-related quality-of-life measures. CONCLUSION: There was no difference in the effectiveness of bipolar radiofrequency ablation and thermal balloon ablation performed in an office setting at 5-year follow-up. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT01124357. LEVEL OF EVIDENCE: I.

On-the-Job Evidence-Based Medicine Training for Clinician-Scientists of the Next Generation.

Clinical scientists are at the unique interface between laboratory science and frontline clinical practice for supporting clinical partnerships for evidence-based practice. In an era of molecular diagnostics and personalised medicine, evidence-based laboratory practice (EBLP) is also crucial in aiding clinical scientists to keep up-to-date with this expanding knowledge base. However, there are recognised barriers to the implementation of EBLP and its training. The aim of this review is to provide a practical summary of potential strategies for training clinician-scientists of the next generation. Current evidence suggests that clinically integrated evidence-based medicine (EBM) training is effective. Tailored e-learning EBM packages and evidence-based journal clubs have been shown to improve knowledge and skills of EBM. Moreover, e-learning is no longer restricted to computer-assisted learning packages. For example, social media platforms such as Twitter have been used to complement existing journal clubs and provide additional post-publication appraisal information for journals. In addition, the delivery of an EBLP curriculum has influence on its success. Although e-learning of EBM skills is effective, having EBM trained teachers available locally promotes the implementation of EBM training. Training courses, such as Training the Trainers, are now available to help trainers identify and make use of EBM training opportunities in clinical practice. On the other hand, peer-assisted learning and trainee-led support networks can strengthen self-directed learning of EBM and research participation among clinical scientists in training. Finally, we emphasise the need to evaluate any EBLP training programme using validated assessment tools to help identify the most crucial ingredients of effective EBLP training. In summary, we recommend on-the-job training of EBM with additional focus on overcoming barriers to its implementation. In addition, future studies evaluating the effectiveness of EBM training should use validated outcome tools, endeavour to achieve adequate power and consider the effects of EBM training on learning environment and patient outcomes.

Bipolar radiofrequency compared with thermal balloon endometrial ablation in the office: a randomized controlled trial.

OBJECTIVE: To estimate the feasibility of local anesthetic endometrial ablation in the office using bipolar radiofrequency endometrial ablation or thermal balloon ablation technologies and to estimate which procedure alleviates heavy menstrual bleeding and improves quality of life more effectively. METHODS: A single-center, single-blind, randomized controlled trial was conducted based in an office hysteroscopy clinic in a university teaching hospital. Eighty-one women with heavy menstrual bleeding without significant intracavity pathology were randomly allocated to bipolar radiofrequency endometrial ablation or thermal balloon ablation in an office setting, avoiding use of general anesthesia or conscious sedation. The primary outcome assessed was the rate of amenorrhea at 6 months after treatment. Secondary outcomes included procedure-related data (feasibility, pain, acceptability, complications) and health-related quality of life. RESULTS: Amenorrhea rates were higher at 6 months after surgery with bipolar procedures, but not statistically significant (39% compared with 21%, risk ratio 1.9, 95% confidence interval 0.9-4.3, P=.1). All bipolar procedures were successfully completed, whereas the treatment cycle was not completed in 2 of 39 (5%) balloon procedures (P>.1) because of patient discomfort. The office bipolar procedure was significantly shorter, by 6.2 minutes on average (P<.001), and associated with more complete coverage of the endometrial surface (88% compared with 58%, P=.002). Health-related quality of life was significantly improved after both treatments. CONCLUSION: Office endometrial ablation using the bipolar radiofrequency or thermal balloon procedures is feasible and effective. The bipolar procedure was significantly quicker and achieved a greater degree of endometrial destruction than the thermal balloon, although there was no significant difference in amenorrhea rates at 6 months. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT01124357. LEVEL OF EVIDENCE: I.

The effectiveness of a clinically integrated e-learning course in evidence-based medicine: a cluster randomised controlled trial.

BACKGROUND: To evaluate the educational effects of a clinically integrated e-learning course for teaching basic evidence-based medicine (EBM) among postgraduates compared to a traditional lecture-based course of equivalent content. METHODS: We conducted a cluster randomised controlled trial in the Netherlands and the UK involving postgraduate trainees in six obstetrics and gynaecology departments. Outcomes (knowledge gain and change in attitude towards EBM) were compared between the clinically integrated e-learning course (intervention) and the traditional lecture based course (control). We measured change from pre- to post-intervention scores using a validated questionnaire assessing knowledge (primary outcome) and attitudes (secondary outcome). RESULTS: There were six clusters involving teaching of 61 postgraduate trainees (28 in the intervention and 33 in the control group). The intervention group achieved slightly higher scores for knowledge gain compared to the control, but these results were not statistically significant (difference in knowledge gain: 3.5 points, 95% CI -2.7 to 9.8, p = 0.27). The attitudinal changes were similar for both groups. CONCLUSION: A clinically integrated e-learning course was at least as effective as a traditional lecture based course and was well accepted. Being less costly than traditional teaching and allowing for more independent learning through materials that can be easily updated, there is a place for incorporating e-learning into postgraduate EBM curricula that offer on-the-job training for just-in-time learning. TRIAL REGISTRATION NUMBER: ACTRN12609000022268.

The educational effects of portfolios on undergraduate student learning: a Best Evidence Medical Education (BEME) systematic review. BEME Guide No. 11.

INTRODUCTION: In recent years, the use of portfolios as learning and assessment tools has become more widespread across the range of health professions. Whilst a growing body of literature has accompanied these trends, there is no clear collated summary of the evidence for the educational effects of the use of portfolios in undergraduate education. This systematic review is the result of our work to provide such a summary. METHODS: We developed a protocol based on the recommendations of the Best Evidence Medical Education (BEME) collaboration. Citations retrieved by electronic searches of 10 databases were assessed against pre-defined inclusion/exclusion criteria by two independent reviewers and full texts of potentially relevant articles were obtained. Studies were identified for inclusion in the review by examination of full text articles by two independent reviewers. At all stages, discrepancies were resolved by consensus. Data relating to characteristics of the student population, intervention, outcome measures, student design and outcomes were collected using a piloted data extraction form. Each study was assessed against 11 quality indicators designed to provide information about how well it was designed and conducted; and against the Kirkpatrick hierarchy as modified for educational settings. Comparisons between different groups were carried out using the Kruskal-Wallis test (non-parametric ANOVA) or the Mann-Whitney U test as appropriate. RESULTS: Electronic searches yielded 2,348 citations. A further 23 citations were obtained by hand searching of reference lists. About 554 full articles were retrieved and assessed against our inclusion criteria. Of the 69 studies included in our review, 18 were from medicine, 32 from nursing and 19 from other allied health professions, including dentistry, physiotherapy and radiography. In all professional groups, portfolios were used mainly in the clinical setting, completion was compulsory, reflection required and assessment (either formative, summative or a combination of both) the norm. Three studies used electronic portfolios. Whilst many studies used a combination of data collection methods, over half of all included studies used questionnaires, a third used focus group interviews and another third used direct assessment of portfolios. Most studies assessed student or tutor perceptions of the effect of the use of portfolios on their learning. Five studies used a comparative design, one of which was a randomized controlled trial. Studies were most likely to meet the quality indicators relating to appropriateness of study subjects, clarity of research question and completeness of data. However, in many studies, methods were not reported in sufficient detail to allow a judgement to be made. About 19 of the 69 included studies (27%) met seven or more quality indicators. Across all professions, such 'higher quality' studies were more likely to have been published recently. The median 'quality score' (number of indicators met) rose from two for studies published in 2000 or earlier to seven for studies published in 2005 or later. Significant differences were observed between the quality scores for studies published in or before 2000 and those published between 2001 and 2004 (p = 0.027), those published in or before 2000 and those published in 2005 or later (p = 0.002) and between all studies (p = 0.004). Similar trends were seen in all professional groups. About 59 (85%) of the included studies were assessed at level 1 of the modified Kirkpatrick hierarchy (i.e. 'participation' effects, including 'post hoc' evaluations of student perceptions of the effects of keeping a portfolio on their learning). About 9 (13%) of the studies reported direct measurement of changes in student skills or attitudes and one study reported a change in student behaviour. The main effects of portfolio use identified by the included studies were: Improvement in student knowledge and understanding (28 studies, six at Kirkpatrick level 2 or above), greater self-awareness and encouragement to reflection (44 studies, seven at Kirkpatrick level 2 or above) and the ability to learn independently (10 studies, one at Kirkpatrick level 2). The findings of higher quality studies also identified benefits in these areas. They reported improved student knowledge and understanding, particularly the ability to integrate theory with practice, although a correlation with improved scores in other assessments was not always apparent. Greater self-awareness and engagement in reflection were also noted, although some studies questioned the quality of the reflection undertaken. Higher quality studies also suggest that use of portfolios improves feedback to students and gives tutors a greater awareness of students' needs, may help students to cope with uncertain or emotionally demanding situations and prepares students for postgraduate settings in which reflective practice is required. Time commitment required to collate a portfolio was the major drawback identified. In two of the studies, this was found to detract from other clinical learning. CONCLUSIONS: At present, the strength and extent of the evidence base for the educational effects of portfolios in the undergraduate setting is limited. However, there is evidence of an improving trend in the quality of reported studies. 'Higher quality' papers identify improvements in knowledge and understanding, increased self-awareness and engagement in reflection and improved student-tutor relationships as the main benefits of portfolio use. However, they also suggest that whilst portfolios encourage students to engage in reflection, the quality of those reflections cannot be assumed and that the time commitment required for portfolio completion may detract from other learning or deter students from engaging with the process unless required to do so by the demands of assessment. Further work is needed to strengthen the evidence base for portfolio use, particularly comparative studies which observe changes in student knowledge and abilities directly, rather than reporting on their perceptions once a portfolio has been completed.

Tips for teaching evidence-based medicine in a clinical setting: lessons from adult learning theory. Part two.

Evidence-based medicine (EBM) is the clinical use of current best available evidence from relevant, valid research. Provision of evidence-based healthcare is the most ethical way to practise as it integrates up-to-date patient-oriented research into the clinical decision-making to improve patients' outcomes. This article provides tips for teachers to teach clinical trainees the final two steps of EBM: integrating evidence with clinical judgement and bringing about change.

Tips for teaching evidence-based medicine in a clinical setting: lessons from adult learning theory. Part one.

Evidence-based medicine (EBM) is an indispensable tool in clinical practice. Teaching and training of EBM to trainee clinicians is patchy and fragmented at its best. Clinically integrated teaching of EBM is more likely to bring about changes in skills, attitudes and behaviour. Provision of evidence-based health care is the most ethical way to practice, as it integrates up-to-date, patient-oriented research into the clinical decision making process, thus improving patients' outcomes. In this article, we aim to dispel the myth that EBM is an academic and statistical exercise removed from practice by providing practical tips for teaching the minimum skills required to ask questions and critically identify and appraise the evidence and presenting an approach to teaching EBM within the existing clinical and educational training infrastructure.