Randomized trials of primary prevention of cardiovascular disease in women. An investigator's view. How many child deaths can we prevent this year? Systematic reviews of health effects of social interventions: 1. Finding the evidence: how far should you go? Improving services for disadvantaged childbearing women. Reducing stillbirths: behavioural and nutritional interventions before and during pregnancy. Meeting the support and information needs of women with advanced breast cancer: a randomised controlled trial. Randomized trials on consider this, a tailored, internet-delivered smoking prevention program for adolescents. Author contacts for retrieval of data for a meta-analysis on exercise and diet restriction.
In recent years, increasing attention has focused on the need for more research to be conducted in women on health issues directly relevant to women. No one would disagree that the need for such studies is both crucial and timely. However, while the need for more research in women is urgent, the planning and conduct of such studies must always be driven by good science. Specifically, investigations in women may have unique and important scientific and logistic problems which must be recognized and addressed. However, if the trials are well designed and conducted, they will provide a sound and reliable body of data upon which to base rational clinical decision making and public health recommendations for women from women. These general issues are discussed in the context of a particular trial, the Women's Health Study, a randomized trial of the risks and benefits of low-dose aspirin, beta-carotene and vitamin E in the primary prevention of cardiovascular disease and cancer among healthy women. This is the second of five papers in the child survival series. The first focused on continuing high rates of child mortality (over 10 million each year) from preventable causes: diarrhoea, pneumonia, measles, malaria, HIV/AIDS, the underlying cause of undernutrition, and a small group of causes leading to neonatal deaths. We review child survival interventions feasible for delivery at high coverage in low-income settings, and classify these as level 1 (sufficient evidence of effect), level 2 (limited evidence), or level 3 (inadequate evidence). Our results show that at least one level-1 intervention is available for preventing or treating each main cause of death among children younger than 5 years, apart from birth asphyxia, for which a level-2 intervention is available. There is also limited evidence for several other interventions. However, global coverage for most interventions is below 50%. If level 1 or 2 interventions were universally available, 63% of child deaths could be prevented. These findings show that the interventions needed to achieve the millennium development goal of reducing child mortality by two-thirds by 2015 are available, but that they are not being delivered to the mothers and children who need them. There is little guidance on how to identify useful evidence about the health effects of social interventions. The aim of this study was to assess the value of different ways of finding this type of information.
                Retrospective analysis of the sources of studies for one systematic review.
                Case study of a systematic review of the effectiveness of interventions in promoting a population shift from using cars towards walking and cycling.
                Only four of the 69 relevant studies were found in a "first-line" health database such as Medline. About half of all relevant studies were found through the specialist Transport database. Nine relevant studies were found through purposive internet searches and seven relevant studies were found by chance. The unique contribution of experts was not to identify additional studies, but to provide more information about those already found in the literature.
                Most of the evidence needed for this review was not found in studies indexed in familiar literature databases. Applying a sensitive search strategy across multiple databases and interfaces is very labour intensive. Retrospective analysis suggests that a more efficient method might have been to search a few key resources, then to ask authors and experts directly for the most robust reports of studies identified. However, internet publications and serendipitous discoveries did make a significant contribution to the total set of relevant evidence. Undertaking a comprehensive search may provide unique evidence and insights that would not be obtained using a more focused search. Tackling health inequalities is high on the political agenda of the Labour government. The government wants to reduce inequalities through policies based on evidence, the health of childbearing women and their babies being priority areas for action. National Service Frameworks (NSFs) are being set up to ensure high quality services for all groups. The External Working Group looking into maternity services for the Children's NSF seeks evidence upon which to plan strategies for all women, while focusing attention on the most disadvantaged. Wide differentials are noted between high- and low-income groups in the outcomes of pregnancy and the health of babies. The worst outcomes appear to be concentrated in small subgroups of disadvantaged women.
                To report on a review of studies of interventions improving perinatal outcomes for disadvantaged women, to inform policy and practice around the organization and delivery of statutory services in the UK.
                We searched six relevant databases for reviews, intervention studies, audits and descriptions of services reporting outcomes for disadvantaged groups of women, published between 1990 and 2003. Synthesis was performed around what works and what does not work. Gaps in the evidence base were identified.
                We found limited evidence of effective and promising interventions for childbearing women from minority ethnic groups, women experiencing domestic violence, women with mental health illness and HIV infected women. Few studies were well-designed or powered to detect effectiveness. There were no studies of interventions for women prisoners, homeless women and travellers.
                Searching for intervention studies primarily by participant subgroup has brought in evidence from few well-designed studies on which to plan policy. Combining this approach with searching for intervention studies addressing behaviour like smoking, and needs like social support, may provide further evidence to tackle inequalities in the perinatal period. The vast majority of global stillbirths occur in low- and middle-income countries, and in many settings, the majority of stillbirths occur antenatally, prior to the onset of labour. Poor nutritional status, lack of antenatal care and a number of behaviours increase women's risk of stillbirth in many resource-poor settings. Interventions to reduce these risks could reduce the resulting burden of stillbirths, but the evidence for the impact of such interventions has not yet been comprehensively evaluated.
                This second paper of a systematic review of interventions that could plausibly impact stillbirth rates covers 12 different interventions relating to behavioural and socially mediated risk factors, including exposures to harmful practices and substances, antenatal care utilisation and quality, and maternal nutrition before and during pregnancy. The search strategy reviewed indexed medical journals on PubMed and the Cochrane Library. If any eligible randomised controlled trials were identified that were published after the most recent Cochrane review, they were added to generate new meta-analyses. Interventions covered in this paper have a focus on low- and middle-income countries, both because of the large burden of stillbirths and because of the high prevalence of risk factors including maternal malnutrition and harmful environmental exposures. The reviews and studies belonging to these interventions were graded and conclusions derived about the evidence of benefit of these interventions.
                From a programmatic perspective, none of the interventions achieved clear evidence of benefit. Evidence for some socially mediated risk factors were identified, such as exposure to indoor air pollution and birth spacing, but still require the development of appropriate interventions. There is a need for additional studies on culturally appropriate behavioural interventions and clinical trials to increase smoking cessation and reduce exposure to smokeless tobacco. Balanced protein-energy supplementation was associated with reduced stillbirth rates, but larger well-designed trials are required to confirm findings. Peri-conceptional folic acid supplementation significantly reduces neural tube defects, yet no significant associated reductions in stillbirth rates have been documented. Evidence for other nutritional interventions including multiple micronutrient and Vitamin A supplementation is weak, suggesting the need for further research to assess potential of nutritional interventions to reduce stillbirths.
                Antenatal care is widely used in low- and middle-income countries, and provides a natural facility-based contact through which to provide or educate about many of the interventions we reviewed. The impact of broader socially mediated behaviors, such as fertility decision-making, access to antenatal care, and maternal diet and exposures like tobacco and indoor air pollution during pregnancy, are poorly understood, and further research and appropriate interventions are needed to test the association of these behaviours with stillbirth outcomes. For most nutritional interventions, larger randomised controlled trials are needed which report stillbirths disaggregated from composite perinatal mortality. Many antepartum stillbirths are potentially preventable in low- and middle-income countries, particularly through dietary and environmental improvement, and through improving the quality of antenatal care - particularly including diagnosis and management of high-risk pregnancies - that pregnant women receive. Addressing psychosocial and quality of life needs is central to provision of excellent care for people with advanced cancer. This study tested a brief nurse-delivered intervention to address the needs of urban women with advanced breast cancer. This study was conducted at four large urban hospitals in Australia. One hundred and five women with advanced breast cancer were recruited and randomised to receive the intervention or usual care, then asked to complete the European Organisation of Research and Treatment of Quality of life Q-C30 version (2.0) (EORTC Q-C30) (version 2) and Supportive Care Needs Survey (SCNS) at 1 month and 3 months postrecruitment. No significant differences were detected between intervention and usual care groups in the SCNS or the EORTC Q-C30 subscale scores. However, when the groups were divided into high needs (score of above 50) and low baseline needs (score of 50 or below) for each SCNS subscale, a significant difference between intervention and usual care groups was found in the psychological/emotional subscale among women with high baseline needs. In conclusions, this study demonstrated that a face-to-face session and follow-up phone call with a breast care nurse significantly reduced the psychological and emotional needs of those with high initial needs. There was no evidence of the intervention influencing the quality of life; or perceived needs of women with low initial psychological/emotional needs or perceived needs in other domains. Possibly, the intervention was not sufficiently intense to achieve an effect. The Internet may be an effective medium for delivering smoking prevention to children. Consider This, an Internet-based program, was hypothesized to reduce expectations concerning smoking and smoking prevalence. Group-randomized pretest-posttest controlled trials were conducted in Australia (n = 2,077) and the United States (n = 1,234) in schools containing Grades 6 through 9. Australian children using Consider This reported reduced 30-day smoking prevalence. This reduction was mediated by decreased subjective norms. The amount of program exposure was low in many classes, but program use displayed a dose-response relationship with reduced smoking prevalence. American children only reported lower expectations for smoking in the future. Intervening to prevent smoking is a challenge, and this data suggest small benefits from an Internet-based program that are unlikely to be of practical significance unless increased by improved implementation. Implementation remains the major challenge to delivering interventions via the Internet, both for health educators and researchers. The mode of contact and response levels of authors who had been asked to provide missing or incomplete data for a systematic review on diet and exercise interventions for weight loss was examined.
                We contacted authors by electronic mail, letter, or both. Survival analyses were performed with the Kaplan-Meier method to determine differences in the proportion of responders over time among the different modes of contact and to determine whether response rates differed between authors from the United States and those from other countries. Logistic regression was used to determine whether the number of items requested and publication date influenced the likelihood of response.
                Two hundred forty-one (39.9 percent) studies had missing or incomplete data (e.g., sample size, age, caloric restriction, exercise amount, and so on). We were unable to locate ninety-five authors (39.4 percent). Of the remaining authors, forty-six authors (31.5 percent) responded to information requests. Time to respond differed by contact method (p < .05): e-mail (3 +/- 3 days), letter (27 +/- 30 days), and both (13 +/-12 days). Response rates from U.S. authors did not differ from those of other countries.
                Our study suggests poor success in the acquisition of essential information. Given considerable time and resources, weight loss studies require improved reporting standards to minimize the relatively unsuccessful attempt to contact authors for important and necessary information.
There are limited data on this important issue and more research is urgently needed.