Regina Kulier

Nutritional Interventions during Pregnancy for the Prevention or Treatment of Maternal Morbidity and Preterm Delivery: An Overview of Randomized Controlled Trials

This overview assesses the effectiveness of nutritional interventions to prevent or treat maternal morbidity, mortality and preterm delivery. Cochrane systematic reviews and other up-to-date systematic reviews and individual randomized controlled trials were sought. Searches were carried out up to July 2002. Iron and folate supplements reduce anemia and should be included in antenatal care programs. Calcium supplementation to women at high risk of hypertension during pregnancy or low calcium intake reduced the incidence of both preeclampsia and hypertension. Fish oil and vitamins E and C are promising for preventing preeclampsia and preterm delivery and need further testing. Vitamin A and beta-carotene reduced maternal mortality in a large trial; ongoing trials should provide further evaluation. No specific nutrient supplementation was identified for reducing preterm delivery. Nutritional advice, magnesium, fish oil and zinc supplementation appear promising and should be tested alone or together in methodologically sound randomized controlled trials. Anema in pregnancy can be prevented and treated effectively. Considering the multifactorial etiology of the other conditions evaluated, it is unlikely that any specific nutrient on its own, blanket interventions or magic bullets will prevent or treat preeclampsia, hemorrhage, obstructed labor, infections, preterm delivery or death during pregnancy. The few promising interventions for specific outcomes should be tested or reconsidered when results of ongoing trials become available. Until then, women and their families should receive support to improve their diets as a general health rule, which is a basic human right.

Nutritional Interventions during Pregnancy for the Prevention or Treatment of Impaired Fetal Growth: An Overview of Randomized Controlled Trials

This paper reviews the efficacy of nutrition interventions to prevent or treat impaired fetal growth. Searches were made for Cochrane systematic reviews and randomized controlled trials published before October 2002. Balanced protein energy supplementation reduced the risk of small for gestational age (SGA) by 30% (95%CI: 20% to 43%) while one trial conducted in New York, U.S., reported a negative effect of high protein supplementation on SGA (RR 1.58; 95%CI: 1.03-2.41). Calcium supplementation protected against low birth weight (RR 0.83; 95%CI: 0.71-0.98). Micronutrient supplements did not affect birth weight, except for magnesium supplementation, which reduced the risk of SGA by 30%. This finding, however, needs or be interpreted with caution because of methodological issues in the data analysis. Programmatic recommendations can be made only for intervening with balanced protein energy supplements, especially in population with a high prevalence of undernutrition. Research is needed to determine the efficacy of multiple micronutrient supplementation and the effect of single micronutrients supplementation on specific growth outcomes such as fetal organ and bone growth. In addition, the public health relevance of these outcomes and their relation to morbidity need to be evaluated.

Guidance for evidence-informed policies about health systems : rationale for and challenges of guidance development

In the first paper in a three-part series on health systems guidance, Xavier Bosch-Capblanch and colleagues examine how guidance is currently formulated in low- and middle-income countries, and the challenges to developing such guidance.

Harmonising evidence-based medicine teaching : a study of the outcomes of e-learning in five European countries

BackgroundWe developed and evaluated the outcomes of an e-learning course for evidence based medicine (EBM) training in postgraduate medical education in different languages and settings across five European countries.MethodsWe measured changes in knowledge and attitudes with well-developed assessment tools before and after administration of the course. The course consisted of five e-learning modules covering acquisition (formulating a question and search of the literature), appraisal, application and implementation of findings from systematic reviews of therapeutic interventions, each with interactive audio-visual learning materials of 15 to 20 minutes duration. The modules were prepared in English, Spanish, German and Hungarian. The course was delivered to 101 students from different specialties in Germany (psychiatrists), Hungary (mixture of specialties), Spain (general medical practitioners), Switzerland (obstetricians-gynaecologists) and the UK (obstetricians-gynaecologists). We analysed changes in scores across modules and countries.ResultsOn average across all countries, knowledge scores significantly improved from pre- to post-course for all five modules (p < 0.001). The improvements in scores were on average 1.87 points (14% of total score) for module 1, 1.81 points (26% of total score) for module 2, 1.9 points (11% of total score) for module 3, 1.9 points (12% of total score) for module 4 and 1.14 points (14% of total score) for module 5. In the country specific analysis, knowledge gain was not significant for module 4 in Spain, Switzerland and the UK, for module 3 in Spain and Switzerland and for module 2 in Spain. Compared to pre-course assessment, after completing the course participants felt more confident that they can assess research evidence and that the healthcare system in their country should have its own programme of research about clinical effectiveness.ConclusionE-learning in EBM can be harmonised for effective teaching and learning in different languages, educational settings and clinical specialties, paving the way for development of an international e-EBM course.

Effectiveness of an e-learning course in evidence-based medicine for foundation (internship) training

Summary Aim To evaluate the educational effectiveness of a clinically integrated e-learning course for teaching basic evidence-based medicine (EBM) among postgraduate medical trainees compared to a traditional lecture-based course of equivalent content. Methods We conducted a cluster randomized controlled trial to compare a clinically integrated e-learning EBM course (intervention) to a lecture-based course (control) among postgraduate trainees at foundation or internship level in seven teaching hospitals in the UK West Midlands region. Knowledge gain among participants was measured with a validated instrument using multiple choice questions. Change in knowledge was compared between groups taking into account the cluster design and adjusted for covariates at baseline using generalized estimating equations (GEE) model. Results There were seven clusters involving teaching of 237 trainees (122 in the intervention and 115 in the control group). The total number of postgraduate trainees who completed the course was 88 in the intervention group and 72 in the control group. After adjusting for baseline knowledge, there was no difference in the amount of improvement in knowledge of EBM between the two groups. The adjusted post course difference between the intervention group and the control group was only 0.1 scoring points (95% CI −1.2–1.4). Conclusion An e-learning course in EBM was as effective in improving knowledge as a standard lecture-based course. The benefits of an e-learning approach need to be considered when planning EBM curricula as it allows standardization of teaching materials and is a potential cost-effective alternative to standard lecture-based teaching.

Copper-containing, framed intrauterine devices for contraception : a systematic review of randomized controlled trials

BACKGROUND Intrauterine devices (IUDs) are safe and effective methods of long-term reversible contraception. The design and copper content as well as placement of the copper on IUDs could affect their effectiveness and side effect profile. We compared different copper IUDs for their effectiveness and side effects. STUDY DESIGN We searched multiple electronic databases with appropriate keywords and names of the IUDs known to be on the market. We searched the reference lists of papers identified and contacted authors when possible. There was no language restriction. Randomized controlled trials comparing different IUDs that reported on clinical outcomes were considered for inclusion. Two reviewers independently extracted data on outcomes and trial characteristics. We combined the trial results in meta-analyses and expressed results as rate difference (RD) using a fixed-effects model with 95% confidence interval (CI). In the presence of significant heterogeneity, a random-effects model was applied. RESULTS We included 35 trials, resulting in 18 comparisons of 10 different IUDs in approximately 48,000 women. TCu380A was more effective in preventing pregnancy than MLCu375 (RD 1.70%, 95% CI 0.07-2.95% after 4 years of use). TCu380A was also more effective than MLCu250, TCu220 and TCu200. There tended to be fewer pregnancies with TCu380S compared to TCu380A after the first year of use, a difference which was statistically significant in the fourth year (RD -1.62%, 95% CI -3.00% to -0.24%). This occurred despite more expulsions with TCu380S (RD 3.50%, 95% CI 0.36-6.63% at 4 years). MLCu375 was no more effective than TCu220 at 1 year of use, or MLCu250 and NovaT up to 3 years. Compared to TCu380A or TCu380S, none of the IUDs showed any benefits in terms of bleeding or pain or any of the other reasons for early discontinuation. None of the trials that reported events at insertion found one IUD easier to insert than another or caused less pain at insertion. There is no evidence that uterine perforation rates vary by type of device. There are minimal randomized data on IUD use in nulliparous women. CONCLUSIONS TCu380A and TCu380S appear to be more effective than other IUDs. No IUD showed consistently lower removal rates for bleeding and pain in comparison to other IUDs. There is no evidence that any particular framed copper device is better suited to women who have not had children.

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

BackgroundTo 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.MethodsWe 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).ResultsThere 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.ConclusionA 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 registrationTrial registration number: ACTRN12609000022268.

Effectiveness of a clinically integrated e-learning course in evidence-based medicine for reproductive health training: a randomized trial.

CONTEXT For evidence-based practice to embed culturally in the workplace, teaching of evidence-based medicine (EBM) should be clinically integrated. In low-middle-income countries (LMICs) there is a scarcity of EBM-trained clinical tutors, lack of protected time for teaching EBM, and poor access to relevant databases in languages other than English. OBJECTIVE To evaluate the effects of a clinically integrated e-learning EBM course incorporating the World Health Organization (WHO) Reproductive Health Library (RHL) on knowledge, skills, and educational environment compared with traditional EBM teaching. DESIGN, SETTING, AND PARTICIPANTS International cluster randomized trial conducted between April 2009 and November 2010 among postgraduate trainees in obstetrics-gynecology in 7 LMICs (Argentina, Brazil, Democratic Republic of the Congo, India, Philippines, South Africa, Thailand). Each training unit was randomized to an experimental clinically integrated course consisting of e-modules using the RHL for learning activities and trainee assessments (31 clusters, 123 participants) or to a control self-directed EBM course incorporating the RHL (29 clusters, 81 participants). A facilitator with EBM teaching experience was available at all teaching units. Courses were administered for 8 weeks, with assessments at baseline and 4 weeks after course completion. The study was completed in 24 experimental clusters (98 participants) and 22 control clusters (68 participants). MAIN OUTCOME MEASURES Primary outcomes were change in EBM knowledge (score range, 0-62) and skills (score range, 0-14). Secondary outcome was educational environment (5-point Likert scale anchored between 1 [strongly agree] and 5 [strongly disagree]). RESULTS At baseline, the study groups were similar in age, year of training, and EBM-related attitudes and knowledge. After the trial, the experimental group had higher mean scores in knowledge (38.1 [95% CI, 36.7 to 39.4] in the control group vs 43.1 [95% CI, 42.0 to 44.1] in the experimental group; adjusted difference, 4.9 [95% CI, 2.9 to 6.8]; P < .001) and skills (8.3 [95% CI, 7.9 to 8.7] vs 9.1 [95% CI, 8.7 to 9.4]; adjusted difference, 0.7 [95% CI, 0.1 to 1.3]; P = .02). Although there was no difference in improvement for the overall score for educational environment (6.0 [95% CI, -0.1 to 12.0] vs 13.6 [95% CI, 8.0 to 19.2]; adjusted difference, 9.6 [95% CI, -6.8 to 26.1]; P = .25), there was an associated mean improvement in the domains of general relationships and support (-0.5 [95% CI, -1.5 to 0.4] vs 0.3 [95% CI, -0.6 to 1.1]; adjusted difference, 2.3 [95% CI, 0.2 to 4.3]; P = .03) and EBM application opportunities (0.5 [95% CI, -0.7 to 1.8] vs 2.9 [95%, CI, 1.8 to 4.1]; adjusted difference, 3.3 [95% CI, 0.1 to 6.5]; P = .04). CONCLUSION In a group of LMICs, a clinically integrated e-learning EBM curriculum in reproductive health compared with a self-directed EBM course resulted in higher knowledge and skill scores and improved educational environment. TRIAL REGISTRATION anzctr.org.au Identifier: ACTRN12609000198224.

Effectiveness and acceptability of progestogens in combined oral contraceptives - a systematic review

BackgroundThe progestogen component of oral contraceptives (OCs) has undergone changes since it was recognized that their chemical structure can influence the spectrum of minor adverse and beneficial effects.MethodsThe objective of this review was to evaluate currently available low-dose OCs containing ethinylestradiol and different progestogens in terms of contraceptive effectiveness, cycle control, side effects and continuation rates. The Cochrane Controlled Trials Register, MEDLINE and EMBASE databases were searched. Randomized trials reporting clinical outcomes were considered for inclusion and were assessed for methodological quality and validity.ResultsTwenty–two trials were included in the review. Eighteen were sponsored by pharmaceutical companies and in only 5 there was an attempt for blinding. Most comparisons between different interventions included one to three trials, involving usually less than 500 women. Discontinuation was less with second-generation progestogens compared to first–generation (RR 0.79; 95% CI 0.69–0.91). Cycle control appeared to be better with second-compared to first-generation progestogens for both, mono-and triphasic preparations (RR 0.69; 95% CI 0.52–0.91) and (RR 0.61; 95% CI 0.43–0.85), respectively. Intermenstrual bleeding was less with third- compared to second-generation pills (RR 0.71; 95% CI 0.55–0.91).Contraceptive effectiveness of gestodene (GSD) was comparable to that of levonorgestrel (LNG), and had similar pattern of spotting, breakthrough bleeding and absence of withdrawal bleeding). Drospirenone (DRSP) was similar compared to desogestrel (DSG) regarding contraceptive effectiveness, cycle control and side effects.ConclusionThe third- and second-generation progestogens are preferred over first generation in all indices of acceptability. Current evidence suggests that GSD is comparable to LNG in terms of contraceptive effectiveness and for most cycle control indices. GSD is also comparable to DSG. DRSP is comparable to DSG. Future research should focus on independently conducted well designed randomized trials comparing particularly the third- with second-generation progestogens.

How far did we get? : How far to go? : A European survey on postgraduate courses in evidence-based medicine

BACKGROUND Over the past decade, evidence-based medicine (EBM) has gained recognition as a means to improve the quality of health care provision. However, little is known about learning opportunities to acquire EBM-associated skills. The EUebm-Unity partnership explored current educational activities for EBM practice for doctors across Europe. METHODS We surveyed organizations offering postgraduate EBM courses across Europe inquiring about their course programme, teaching content and strategies, and interest in a Europe-wide curriculum in EBM. RESULTS One hundred and fifty-six organizers in eight European countries reported 403 courses that had started first-time from 1996 to 2006. Despite a steady increase, in absolute terms, the frequency of courses was low and varied from 1 first-time offering of a course per 640 doctors (Spain) to 1 first-time offering per 5600 doctors (Austria) over 10 years. Most adopted the McMaster EBM teaching concept of small group, problem-based learning focussing on interventions, diagnostic tests and guidelines, and included efforts to link EBM to patient care. Teaching staff consisted of doctors from academic and non-academic settings, supported by methodologists. Efforts to formally integrate EBM in postgraduate activities were only partially successful. Most organizations welcomed a standardized European qualification in EBM. A limitation of the survey is the lack of follow-up information about the continuation of courses following the first-time offering. CONCLUSIONS All countries offer some EBM courses with varying teaching intensity. Learning opportunities are insufficient to ensure widespread dissemination of knowledge and skills. Most countries welcome more efforts to develop inexpensive and feasible educational activities at a postgraduate level.