Hilda Bastian

Seventy-five trials and eleven systematic reviews a day: How will we ever keep up?

Hilda Bastian and colleagues examine the extent to which critical summaries of clinical trials can be used by health professionals and the public.

Effects of treatment in women with gestational diabetes mellitus: systematic review and meta-analysis

Objective To summarise the benefits and harms of treatments for women with gestational diabetes mellitus. Design Systematic review and meta-analysis of randomised controlled trials. Data sources Embase, Medline, AMED, BIOSIS, CCMed, CDMS, CDSR, CENTRAL, CINAHL, DARE, HTA, NHS EED, Heclinet, SciSearch, several publishers’ databases, and reference lists of relevant secondary literature up to October 2009. Review methods Included studies were randomised controlled trials of specific treatment for gestational diabetes compared with usual care or “intensified” compared with “less intensified” specific treatment. Results Five randomised controlled trials matched the inclusion criteria for specific versus usual treatment. All studies used a two step approach with a 50 g glucose challenge test or screening for risk factors, or both, and a subsequent 75 g or 100 g oral glucose tolerance test. Meta-analyses did not show significant differences for most single end points judged to be of direct clinical importance. In women specifically treated for gestational diabetes, shoulder dystocia was significantly less common (odds ratio 0.40, 95% confidence interval 0.21 to 0.75), and one randomised controlled trial reported a significant reduction of pre-eclampsia (2.5 v 5.5%, P=0.02). For the surrogate end point of large for gestational age infants, the odds ratio was 0.48 (0.38 to 0.62). In the 13 randomised controlled trials of different intensities of specific treatments, meta-analysis showed a significant reduction of shoulder dystocia in women with more intensive treatment (0.31, 0.14 to 0.70). Conclusions Treatment for gestational diabetes, consisting of treatment to lower blood glucose concentration alone or with special obstetric care, seems to lower the risk for some perinatal complications. Decisions regarding treatment should take into account that the evidence of benefit is derived from trials for which women were selected with a two step strategy (glucose challenge test/screening for risk factors and oral glucose tolerance test).

Taking healthcare interventions from trial to practice

The results of thousands of trials are never acted on because their published reports do not describe the interventions in enough detail. How can we improve the reporting?

PRISMA for Abstracts: Reporting Systematic Reviews in Journal and Conference Abstracts

Elaine Beller and colleagues from the PRISMA for Abstracts group provide a reporting guidelines for reporting abstracts of systematic reviews in journals and at conferences.

Perinatal death associated with planned home birth in Australia: population based study

abstract Objective : To assess the risk of perinatal death in planned home births in Australia. Design : Comparison of data on planned home births during 1985-90, notified to Homebirth Australia, with national data on perinatal deaths and outcomes of home births internationally. Results : 50 perinatal deaths occurred in 7002 planned home births in Australia during 1985-90: 7.1 per 1000 (95% confidence interval 5.2 to 9.1) according to Australian definitions and 6.4 per 1000 (4.6 to 8.3) according to World Health Organisation definitions. The perinatal death rate in infants weighing more than 2500 g was higher than the national average (5.7 versus 3.6 per 1000: relative risk 1.6; 1.1 to 2.4) as were intrapartum deaths not due to malformations or immaturity (2.7 versus 0.9 per 1000: 3.0; 1.9 to 4.8). More than half (52%) of the deaths were associated with intrapartum asphyxia. Conclusions : Australian home births carried a high death rate compared with both all Australian births and home births elsewhere. The two largest contributors to the excess mortality were underestimation of the risks associated with post-term birth, twin pregnancy and breech presentation, and a lack of response to fetal distress.

Speaking Up for Ourselves: The Evolution of Consumer Advocacy in Health Care

Forces from communities and from health care are pushing toward more consumer involvement in health care internationally. This article addresses the philosophies and rationales behind this trend and traces the history and development of consumer advocacy in health care.

Health literacy and patient information: Developing the methodology for a national evidence-based health website

OBJECTIVE To define evidence-based health information and the conceptual framework and methodology of Germanys national health information website. METHODS Description of the political and methodological processes in the development of the website Gesundheitsinformation.de/Informed Health Online developed by the Institute of Quality and Efficiency in Health Care (IQWiG). RESULTS Autonomy, empowerment and health literacy were useful theoretical concepts to guide the definition of evidence-based health information and the objectives and methodologies used for developing this website. These choices had direct practical consequences for the patient information. CONCLUSION Evidence-based patient information involves the use of evidence and systematic methodologies in several facets of information provision. These include a process of information development that minimises bias, evidence as the information basis for the content, and the use of evidence-based communication techniques. To be empowering and support patient autonomy, information should be patient-centred and non-directive. PRACTICE IMPLICATIONS Health websites are communication interventions which can have very different objectives and methods. A conceptual framework can help guide these choices and provide a basis for subsequent evaluation.

German health care: a bit of Bismarck plus more science

Germany’s health system provides good access to care for all patients. But, as Peter Sawicki and Hilda Bastian explain, it is increasingly turning to science to determine what is good value

What are the effects of the fifth revision of the Declaration of Helsinki

# What are the effects of the fifth revision of the Declaration of Helsinki? {#article-title-2} The World Medical Associations fifth revision of the Declaration of Helsinki strives to strike a balance between ensuring high ethical standards and retaining sufficient sensitivity to local circumstances, especially in developing world research, to avoid thwarting research with bureaucracy. Has the balance been achieved? We asked researchers working in the developing world, the developed world, and the pharmaceutical industry, as well as a patient representative, to comment. # Fair partnerships support ethical research {#article-title-3} The World Medical Association describes the Declaration of Helsinki as a statement of ethical principles to guide physicians and other participants in medical research involving human subjects, including identifiable human tissue or data.1 When producing the fifth revision, representatives of the 71 affiliated medical associations were especially concerned that research in developing settings—and particularly clinical trials—meet the highest ethical standards of conduct. However, despite the increasingly inclusive aspirations of the revised declaration, some of the absolute and exclusionary language could unintentionally endanger research in developing countries. One of the fundamental changes to the declaration is clause 29. This states that new treatments should be tested against best current treatment rather than placebo (box). The clause was formulated in response to sustained criticism of field trials in developing countries that tested short course therapies aimed at preventing vertical transmission of HIV using placebo controls.2–4 It implies that local circumstances—sociopolitical, financial, infrastructural, cultural—can never justify failure to use the best known drugs or technologies in the control arm. Its intention is clear: #### Clause 29 of the Declaration of Helsinki The benefits, risks, burdens and effectiveness of a new method should be tested against those of the best current prophylactic, diagnostic, and therapeutic methods. This does not exclude the use of placebo, or no treatment, in studies where no proven prophylactic, diagnostic or therapeutic method exists. Correspondence to: L J Hirsch

Competing or complementary? Ethical considerations and the quality of randomized trials.

The ethical principles of beneficence (doing the best for ones patients and clients), nonmaleficence (doing no harm), autonomy, justice, and equity, are positively associated with the quality of a trial rather than being opposed to it. Ethical considerations involve such important questions as appropriate design and documentation, participation rates, withdrawals or losses to follow-up, careful monitoring of safety and efficacy, timely completion, generalizability, and publication and dissemination of findings. When conflicts between ethical considerations and the trials scientific quality do occur, the ethical considerations must be paramount.