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Intimate Partner Violence and Incident Depressive Symptoms and Suicide Attempts: A Systematic Review of Longitudinal Studies
Source: PLoS Medicine
Background
Depression and suicide are responsible for a substantial burden of disease globally. Evidence suggests that intimate partner violence (IPV) experience is associated with increased risk of depression, but also that people with mental disorders are at increased risk of violence. We aimed to investigate the extent to which IPV experience is associated with incident depression and suicide attempts, and vice versa, in both women and men.
Methods and Findings
We conducted a systematic review and meta-analysis of longitudinal studies published before February 1, 2013. More than 22,000 records from 20 databases were searched for studies examining physical and/or sexual intimate partner or dating violence and symptoms of depression, diagnosed major depressive disorder, dysthymia, mild depression, or suicide attempts. Random effects meta-analyses were used to generate pooled odds ratios (ORs). Sixteen studies with 36,163 participants met our inclusion criteria. All studies included female participants; four studies also included male participants. Few controlled for key potential confounders other than demographics. All but one depression study measured only depressive symptoms. For women, there was clear evidence of an association between IPV and incident depressive symptoms, with 12 of 13 studies showing a positive direction of association and 11 reaching statistical significance; pooled OR from six studies = 1.97 (95% CI 1.56–2.48, I2 = 50.4%, pheterogeneity = 0.073). There was also evidence of an association in the reverse direction between depressive symptoms and incident IPV (pooled OR from four studies = 1.93, 95% CI 1.51–2.48, I2 = 0%, p = 0.481). IPV was also associated with incident suicide attempts. For men, evidence suggested that IPV was associated with incident depressive symptoms, but there was no clear evidence of an association between IPV and suicide attempts or depression and incident IPV.
Conclusions
In women, IPV was associated with incident depressive symptoms, and depressive symptoms with incident IPV. IPV was associated with incident suicide attempts. In men, few studies were conducted, but evidence suggested IPV was associated with incident depressive symptoms. There was no clear evidence of association with suicide attempts.
Changing Patterns in Place of Cancer Death in England: A Population-Based Study
Changing Patterns in Place of Cancer Death in England: A Population-Based Study
Source: PLoS Medicine
Background
Most patients with cancer prefer to die at home or in a hospice, but hospitals remain the most common place of death (PoD).This study aims to explore the changing time trends of PoD and the associated factors, which are essential for end-of-life care improvement.
Methods and Findings
The study analysed all cancer deaths in England collected by the Office for National Statistics during 1993–2010 (n = 2,281,223). Time trends of age- and gender-standardised proportion of deaths in individual PoDs were evaluated using weighted piecewise linear regression. Variables associated with PoD (home or hospice versus hospital) were determined using proportion ratio (PR) derived from the log-binomial regression, adjusting for clustering effects. Hospital remained the most common PoD throughout the study period (48.0%; 95% CI 47.9%–48.0%), followed by home (24.5%; 95% CI 24.4%–24.5%), and hospice (16.4%; 95% CI 16.3%–16.4%). Home and hospice deaths increased since 2005 (0.87%; 95% CI 0.74%–0.99%/year, 0.24%; 95% CI 0.17%–0.32%/year, respectively, p<0.001), while hospital deaths declined (−1.20%; 95% CI −1.41 to −0.99/year, p<0.001). Patients who died from haematological cancer (PRs 0.46–0.52), who were single, widowed, or divorced (PRs 0.75–0.88), and aged over 75 (PRs 0.81–0.84 for 75–84; 0.66–0.72 for 85+) were less likely to die in home or hospice (p<0.001; reference groups: colorectal cancer, married, age 25–54). There was little improvement in patients with lung cancer of dying in home or hospice (PRs 0.87–0.88). Marital status became the second most important factor associated with PoD, after cancer type. Patients from less deprived areas (higher quintile of the deprivation index) were more likely to die at home or in a hospice than those from more deprived areas (lower quintile of the deprivation index; PRs 1.02–1.12). The analysis is limited by a lack of data on individual patients’ preferences for PoD or a clinical indication of the most appropriate PoD.
Conclusions
More efforts are needed to reduce hospital deaths. Health care facilities should be improved and enhanced to support the increased home and hospice deaths. People who are single, widowed, or divorced should be a focus for end-of-life care improvement, along with known at risk groups such as haematological cancer, lung cancer, older age, and deprivation.
Adapting Standards: Ethical Oversight of Participant-Led Health Research
Adapting Standards: Ethical Oversight of Participant-Led Health Research
Source: PLoS Medicine
Summary Points
- Online social media and digital technologies have facilitated formation of communities of individuals engaged in establishing and conducting health research projects. The results of such participant-led research (PLR) have already appeared in leading biomedical journals.
- These projects involve research with human participants. Hence, what are the requirements for ethical oversight? To what extent is standard ethics review also suitable for PLR?
- A comparison of PLR with standard research reveals six areas that are of potential relevance to ethical oversight: institutionalization, state recognition and support, incentive structures, openness, bottom-up approach, and self-experimentation.
- The distinctive nature of PLR requires adaptation of ethical oversight standards to the character of such research. These should strike a balance between protecting interests of research participants and achieving promised benefits of PLR.
- The appropriate form of ethical oversight for PLR projects depends on which of three categories they fall into. If they meet the “institution-plus” criterion, standard ethics review applies. If not, then the appropriate form of oversight depends on the application of a minimal risk criterion.
Tackling Non-Communicable Diseases In Low- and Middle-Income Countries: Is the Evidence from High-Income Countries All We Need?
Source: PLoS Medicine
Summary Points
- Applied health research and development for non-communicable diseases (NCDs) in low- and middle-income countries (LMICs) is limited, and despite repeat calls for action, the NCD burden is increasing unchecked.
- NCD research in high-income countries (HICs) and LMICs can result in mutual advantages in the areas of replication and extending findings; discovering new causes of NCDs; studying health effects of exposures rare or ubiquitous in HICs; and exploring links between infectious diseases and NCDs.
- Different NCDs are at varying stages of needing research, policy development, and action. These stages range from not knowing the population burden of many NCDs to knowing all we need to take action.
- Changes in the global and national funding agendas will be required to strengthen the research and health system capacity for NCDs, which should reduce deaths and disability attributable to NCDs and yield economic dividends.
National, Regional, and Global Trends in Infertility Prevalence Since 1990: A Systematic Analysis of 277 Health Surveys
Source: PLoS Medicine
Background
Global, regional, and national estimates of prevalence of and tends in infertility are needed to target prevention and treatment efforts. By applying a consistent algorithm to demographic and reproductive surveys available from developed and developing countries, we estimate infertility prevalence and trends, 1990 to 2010, by country and region.
Methods and Findings
We accessed and analyzed household survey data from 277 demographic and reproductive health surveys using a consistent algorithm to calculate infertility. We used a demographic infertility measure with live birth as the outcome and a 5-y exposure period based on union status, contraceptive use, and desire for a child. We corrected for biases arising from the use of incomplete information on past union status and contraceptive use. We used a Bayesian hierarchical model to estimate prevalence of and trends in infertility in 190 countries and territories. In 2010, among women 20–44 y of age who were exposed to the risk of pregnancy, 1.9% (95% uncertainty interval 1.7%, 2.2%) were unable to attain a live birth (primary infertility). Out of women who had had at least one live birth and were exposed to the risk of pregnancy, 10.5% (9.5%, 11.7%) were unable to have another child (secondary infertility). Infertility prevalence was highest in South Asia, Sub-Saharan Africa, North Africa/Middle East, and Central/Eastern Europe and Central Asia. Levels of infertility in 2010 were similar to those in 1990 in most world regions, apart from declines in primary and secondary infertility in Sub-Saharan Africa and primary infertility in South Asia (posterior probability [pp] ≥0.99). Although there were no statistically significant changes in the prevalence of infertility in most regions amongst women who were exposed to the risk of pregnancy, reduced child-seeking behavior resulted in a reduction of primary infertility among all women from 1.6% to 1.5% (pp = 0.90) and a reduction of secondary infertility among all women from 3.9% to 3.0% (pp>0.99) from 1990 to 2010. Due to population growth, however, the absolute number of couples affected by infertility increased from 42.0 million (39.6 million, 44.8 million) in 1990 to 48.5 million (45.0 million, 52.6 million) in 2010. Limitations of the study include gaps in survey data for some countries and the use of proxies to determine exposure to pregnancy.
Conclusions
We analyzed demographic and reproductive household survey data to reveal global patterns and trends in infertility. Independent from population growth and worldwide declines in the preferred number of children, we found little evidence of changes in infertility over two decades, apart from in the regions of Sub-Saharan Africa and South Asia. Further research is needed to identify the etiological causes of these patterns and trends.
See: Global Rates of Infertility Remain Unchanged Over Past 2 Decades (Science Daily)
The Air That We Breathe: Addressing the Risks of Global Urbanization on Health
The Air That We Breathe: Addressing the Risks of Global Urbanization on Health
Source: PLoS Medicine
More than half of the world’s population now live in cities [1], and while urbanization has the potential to allow greater access to health care for all, huge discrepancies in how resources are allocated within cities result in major inequities in health [2]. Addressing these discrepancies and improving health require accurate assessment. To that point, earlier this month PLOS Medicine published a Policy Forum article by Jason Corburn and Alison Cohen that focused on the urbanizing planet and the need for health equity indicators to guide public health policy in cities and urban areas [2].
The major theme of Corburn and Cohen’s argument is that if societies are to ensure those living in the poorest urban slums have the same right to health as people living on the richest boulevards, health indicators must allow for the identification of where health inequities exist. For example, while indicators in Nairobi measure population access to communal toilet blocks, they give no information as to whether the toilet blocks are hygienic or safe to use and therefore mask inequity within the city. Such indicators, however, would have little value in cities like London or New York, which illustrates the need for context-specific measures.
What Is the Relationship of Medical Humanitarian Organisations with Mining and Other Extractive Industries?
What Is the Relationship of Medical Humanitarian Organisations with Mining and Other Extractive Industries?
Source: PLoS Medicine
Summary Points
- In developing countries, extractive industries (including ore mineral mining and oil extraction) have far reaching consequences on health through environmental pollution, some communicable diseases, violence, destitution, and compromised food security.
- The rapid expansion of extractive industries and the increasing frequency of environmental disasters are bound to engage medical humanitarian organisations in developing novel types of expertise.
- While humanitarian organisations might be called to intervene in areas occupied by the extractive sector, in this Essay I argue that oil and mineral exploitation reveals a fundamental clash of values between humanitarianism, the for-profit sector, and privatised global philanthropy.
Specific medical humanitarian organisations can respond to these challenges in different ways, based on their position between pragmatic or principled approaches, and their willingness to develop new technical capacities.
Challenges for HIV Pre-Exposure Prophylaxis among Men Who Have Sex with Men in the United States
Challenges for HIV Pre-Exposure Prophylaxis among Men Who Have Sex with Men in the United States
Source: PLoS Medicine
Summary Points
+ Pre-exposure prophylaxis (PrEP) with anti-retroviral (ARV) medications is partially efficacious for preventing HIV infection among men who have sex with men (MSM) and heterosexuals.
As PrEP becomes available and prescribed for use among MSM a better understanding of willingness to use PrEP and avoidance of condom use are needed so that behavioral programs and counseling may be enhanced for maximum benefit.
+ Targeted messaging will be needed about ARV prophylaxis for various at risk populations, but the general message should be that condoms continue to be the most effective way to prevent HIV transmission through sex and that PrEP is an additional biomedical intervention.
+ As new effective biomedical intervention methods, such as PrEP, become available language about “protected” and “unprotected” sex, which used to exclusively mean condom use, will need to adapt.
How Does Medical Device Regulation Perform in the United States and the European Union? A Systematic Review
How Does Medical Device Regulation Perform in the United States and the European Union? A Systematic Review
Source: PLoS Medicine
Background
Policymakers and regulators in the United States (US) and the European Union (EU) are weighing reforms to their medical device approval and post-market surveillance systems. Data may be available that identify strengths and weakness of the approaches to medical device regulation in these settings.Methods and Findings
We performed a systematic review to find empirical studies evaluating medical device regulation in the US or EU. We searched Medline using two nested categories that included medical devices and glossary terms attributable to the US Food and Drug Administration and the EU, following PRISMA guidelines for systematic reviews. We supplemented this search with a review of the US Government Accountability Office online database for reports on US Food and Drug Administration device regulation, consultations with local experts in the field, manual reference mining of selected articles, and Google searches using the same key terms used in the Medline search. We found studies of premarket evaluation and timing (n = 9), studies of device recalls (n = 8), and surveys of device manufacturers (n = 3). These studies provide evidence of quality problems in pre-market submissions in the US, provide conflicting views of device safety based largely on recall data, and relay perceptions of some industry leaders from self-surveys.Conclusions
Few studies have quantitatively assessed medical device regulation in either the US or EU. Existing studies of US and EU device approval and post-market evaluation performance suggest that policy reforms are necessary for both systems, including improving classification of devices in the US and promoting transparency and post-market oversight in the EU. Assessment of regulatory performance in both settings is limited by lack of data on post-approval safety outcomes. Changes to these device approval and post-marketing systems must be accompanied by ongoing research to ensure that there is better assessment of what works in either setting.
PLoS Medicine Series on Big Food
PLoS Medicine Series on Big Food
Source: PLoS Medicine
The PLoS Medicine series on Big Food aims to examine and stimulate debate about the activities and influence of the food industry in global health. We define “Big Food” as the multinational food and beverage industry with huge and concentrated market power. The series adopts a multi-disciplinary approach and includes critical perspectives from around the world. It represents one of first times such issues have been examined in the general medical literature.
The PLoS Medicine Editors begin the series with an editorial discussing the rationale and process of commissioning articles for the series. As they note, industry in health has long fascinated PLoS Medicine but the journal’s focus on Big Food is new. Food, unlike tobacco and drugs, is necessary to live and is central to health and disease. And yet the big multinational food companies control what people everywhere eat, resulting in a stark and sick irony: one billion people on the planet are hungry while two billion are obese or overweight. The guest editors, Marion Nestle and David Stuckler, then lay out a background to the role of Big Food in global health, and offer three competing views of how public health professionals can respond. Subsequent articles include: a comparison of soda companies’ corporate social responsibility campaigns with those of the tobacco industry; an analysis of the rapid rise of Big Food sales in developing countries; an essay on food sovereignty and who holds power over food; views from South America and Africa on the displacement of traditional diets by the incursion of multinational food companies; and a perspective arguing against an uncritical acceptance of the food industry in health.
Comparative Performance of Private and Public Healthcare Systems in Low- and Middle-Income Countries: A Systematic Review
Source: PLoS Medicine
Introduction
Private sector healthcare delivery in low- and middle-income countries is sometimes argued to be more efficient, accountable, and sustainable than public sector delivery. Conversely, the public sector is often regarded as providing more equitable and evidence-based care. We performed a systematic review of research studies investigating the performance of private and public sector delivery in low- and middle-income countries.
Methods and Findings
Peer-reviewed studies including case studies, meta-analyses, reviews, and case-control analyses, as well as reports published by non-governmental organizations and international agencies, were systematically collected through large database searches, filtered through methodological inclusion criteria, and organized into six World Health Organization health system themes: accessibility and responsiveness; quality; outcomes; accountability, transparency, and regulation; fairness and equity; and efficiency. Of 1,178 potentially relevant unique citations, data were obtained from 102 articles describing studies conducted in low- and middle-income countries. Comparative cohort and cross-sectional studies suggested that providers in the private sector more frequently violated medical standards of practice and had poorer patient outcomes, but had greater reported timeliness and hospitality to patients. Reported efficiency tended to be lower in the private than in the public sector, resulting in part from perverse incentives for unnecessary testing and treatment. Public sector services experienced more limited availability of equipment, medications, and trained healthcare workers. When the definition of “private sector” included unlicensed and uncertified providers such as drug shop owners, most patients appeared to access care in the private sector; however, when unlicensed healthcare providers were excluded from the analysis, the majority of people accessed public sector care. “Competitive dynamics” for funding appeared between the two sectors, such that public funds and personnel were redirected to private sector development, followed by reductions in public sector service budgets and staff.
Conclusions
Studies evaluated in this systematic review do not support the claim that the private sector is usually more efficient, accountable, or medically effective than the public sector; however, the public sector appears frequently to lack timeliness and hospitality towards patients.
Improving Access to Mental Health Care and Psychosocial Support within a Fragile Context: A Case Study from Afghanistan
Summary Points+ After the fall of the Taliban, the rebuilding of the Afghan health care system, from scratch, provided opportunities to integrate mental health into basic health services through the use of funds that became available during this complex humanitarian emergency.+ Practice-oriented mental health trainings for general health workers and ongoing clinical supervision in the basic health care system led to substantially increased demand for and access to basic mental health care services.+ Treatment of mental disorders within the health care system needs to be accompanied by a community-based approach that focuses on psychosocial problems.+ Addressing service delivery needs in a fragile state has to be accompanied by capacity building and policy development in order to foster structural changes within the health care system.
Improving Access to Mental Health Care and Psychosocial Support within a Fragile Context: A Case Study from Afghanistan
Summary Points+ After the fall of the Taliban, the rebuilding of the Afghan health care system, from scratch, provided opportunities to integrate mental health into basic health services through the use of funds that became available during this complex humanitarian emergency.+ Practice-oriented mental health trainings for general health workers and ongoing clinical supervision in the basic health care system led to substantially increased demand for and access to basic mental health care services.+ Treatment of mental disorders within the health care system needs to be accompanied by a community-based approach that focuses on psychosocial problems.+ Addressing service delivery needs in a fragile state has to be accompanied by capacity building and policy development in order to foster structural changes within the health care system.
See: Community and health system approaches improves mental health in Afghanistan (EurekAlert!)
Planned Vaginal Birth or Elective Repeat Caesarean: Patient Preference Restricted Cohort with Nested Randomised Trial
BackgroundUncertainty exists about benefits and harms of a planned vaginal birth after caesarean (VBAC) compared with elective repeat caesarean (ERC). We conducted a prospective restricted cohort study consisting of a patient preference cohort study, and a small nested randomised trial to compare benefits and risks of a planned ERC with planned VBAC.Methods and findings2,345 women with one prior caesarean, eligible for VBAC at term, were recruited from 14 Australian maternity hospitals. Women were assigned by patient preference (n = 2,323) or randomisation (n = 22) to planned VBAC (1,225 patient preference, 12 randomised) or planned ERC (1,098 patient preference, ten randomised). The primary outcome was risk of fetal death or death of liveborn infant before discharge or serious infant outcome. Data were analysed for the 2,345 women (100%) and infants enrolled.The risk of fetal death or liveborn infant death prior to discharge or serious infant outcome was significantly lower for infants born in the planned ERC group compared with infants in the planned VBAC group (0.9% versus 2.4%; relative risk [RR] 0.39; 95% CI 0.19–0.80; number needed to treat to benefit 66; 95% CI 40–200). Fewer women in the planned ERC group compared with women in the planned VBAC had a major haemorrhage (blood loss ≥1,500 ml and/or blood transfusion), (0.8% [9/1,108] versus 2.3% [29/1,237]; RR 0.37; 95% CI 0.17–0.80).ConclusionsAmong women with one prior caesarean, planned ERC compared with planned VBAC was associated with a lower risk of fetal and infant death or serious infant outcome. The risk of major maternal haemorrhage was reduced with no increase in maternal or perinatal complications to time of hospital discharge. Women, clinicians, and policy makers can use this information to develop health advice and make decisions about care for women who have had a previous caesarean.
Where There Is No Health Research: What Can Be Done to Fill the Global Gaps in Health Research?
Summary Points+ Efforts to strengthen capacity in health research have, so far, concentrated on countries where there is existing capacity rather than those where it is almost completely lacking.+ Judged by absolute numbers of scientific papers, those with the fewest are mainly small islands and a few countries that are politically isolated.+ Judged by papers per capita, the lowest include countries in the former Soviet Union and Africa, both regions experiencing declines in life expectancy in recent years, and states experiencing conflict.+ Although there is a positive association between economic development and research output, some relatively wealthy countries seriously underperform.+ There are many examples of good practice, including regional networks and international partnerships.+ There is a strong argument for donors to look to the long term and consider how best to build health research capacity where it is virtually absent.
A Comparison of DSM-IV and DSM-5 Panel Members’ Financial Associations with Industry: A Pernicious Problem Persists
Summary Points+ The American Psychiatric Association (APA) instituted a financial conflict of interest disclosure policy for the 5th edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM).+ The new disclosure policy has not been accompanied by a reduction in the financial conflicts of interest of DSM panel members.+ Transparency alone cannot mitigate the potential for bias and is an insufficient solution for protecting the integrity of the revision process.+ Gaps in APA’s disclosure policy are identified and recommendations for more stringent safeguards are offered.
Is Food Insecurity Associated with HIV Risk? Cross-Sectional Evidence from Sexually Active Women in Brazil
BackgroundUnderstanding how food insecurity among women gives rise to differential patterning in HIV risks is critical for policy and programming in resource-limited settings. This is particularly the case in Brazil, which has undergone successive changes in the gender and socio-geographic composition of its complex epidemic over the past three decades. We used data from a national survey of Brazilian women to estimate the relationship between food insecurity and HIV risk.Methods and FindingsWe used data on 12,684 sexually active women from a national survey conducted in Brazil in 2006–2007. Self-reported outcomes were (a) consistent condom use, defined as using a condom at each occasion of sexual intercourse in the previous 12 mo; (b) recent condom use, less stringently defined as using a condom with the most recent sexual partner; and (c) itchy vaginal discharge in the previous 30 d, possibly indicating presence of a sexually transmitted infection. The primary explanatory variable of interest was food insecurity, measured using the culturally adapted and validated Escala Brasiliera de Segurança Alimentar. In multivariable logistic regression models, severe food insecurity with hunger was associated with a reduced odds of consistent condom use in the past 12 mo (adjusted odds ratio [AOR] = 0.67; 95% CI, 0.48–0.92) and condom use at last sexual intercourse (AOR = 0.75; 95% CI, 0.57–0.98). Self-reported itchy vaginal discharge was associated with all categories of food insecurity (with AORs ranging from 1.46 to 1.94). In absolute terms, the effect sizes were large in magnitude across all outcomes. Underweight and/or lack of control in sexual relations did not appear to mediate the observed associations.ConclusionsSevere food insecurity with hunger was associated with reduced odds of condom use and increased odds of itchy vaginal discharge, which is potentially indicative of sexually transmitted infection, among sexually active women in Brazil. Interventions targeting food insecurity may have beneficial implications for HIV prevention in resource-limited settings.
A Comparison of DSM-IV and DSM-5 Panel Members’ Financial Associations with Industry: A Pernicious Problem Persists
Summary Points
- The American Psychiatric Association (APA) instituted a financial conflict of interest disclosure policy for the 5th edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM).
- The new disclosure policy has not been accompanied by a reduction in the financial conflicts of interest of DSM panel members.
- Transparency alone cannot mitigate the potential for bias and is an insufficient solution for protecting the integrity of the revision process.
- Gaps in APA’s disclosure policy are identified and recommendations for more stringent safeguards are offered.
Publication Bias in Antipsychotic Trials: An Analysis of Efficacy Comparing the Published Literature to the US Food and Drug Administration Database
BackgroundPublication bias compromises the validity of evidence-based medicine, yet a growing body of research shows that this problem is widespread. Efficacy data from drug regulatory agencies, e.g., the US Food and Drug Administration (FDA), can serve as a benchmark or control against which data in journal articles can be checked. Thus one may determine whether publication bias is present and quantify the extent to which it inflates apparent drug efficacy.Methods and FindingsFDA Drug Approval Packages for eight second-generation antipsychotics—aripiprazole, iloperidone, olanzapine, paliperidone, quetiapine, risperidone, risperidone long-acting injection (risperidone LAI), and ziprasidone—were used to identify a cohort of 24 FDA-registered premarketing trials. The results of these trials according to the FDA were compared with the results conveyed in corresponding journal articles. The relationship between study outcome and publication status was examined, and effect sizes derived from the two data sources were compared. Among the 24 FDA-registered trials, four (17%) were unpublished. Of these, three failed to show that the study drug had a statistical advantage over placebo, and one showed the study drug was statistically inferior to the active comparator. Among the 20 published trials, the five that were not positive, according to the FDA, showed some evidence of outcome reporting bias. However, the association between trial outcome and publication status did not reach statistical significance. Further, the apparent increase in the effect size point estimate due to publication bias was modest (8%) and not statistically significant. On the other hand, the effect size for unpublished trials (0.23, 95% confidence interval 0.07 to 0.39) was less than half that for the published trials (0.47, 95% confidence interval 0.40 to 0.54), a difference that was significant.ConclusionsThe magnitude of publication bias found for antipsychotics was less than that found previously for antidepressants, possibly because antipsychotics demonstrate superiority to placebo more consistently. Without increased access to regulatory agency data, publication bias will continue to blur distinctions between effective and ineffective drugs.
Planned Vaginal Birth or Elective Repeat Caesarean: Patient Preference Restricted Cohort with Nested Randomised Trial
Planned Vaginal Birth or Elective Repeat Caesarean: Patient Preference Restricted Cohort with Nested Randomised Trial
Source: PLoS Medicine
Background
Uncertainty exists about benefits and harms of a planned vaginal birth after caesarean (VBAC) compared with elective repeat caesarean (ERC). We conducted a prospective restricted cohort study consisting of a patient preference cohort study, and a small nested randomised trial to compare benefits and risks of a planned ERC with planned VBAC.
Methods and findings
2,345 women with one prior caesarean, eligible for VBAC at term, were recruited from 14 Australian maternity hospitals. Women were assigned by patient preference (n = 2,323) or randomisation (n = 22) to planned VBAC (1,225 patient preference, 12 randomised) or planned ERC (1,098 patient preference, ten randomised). The primary outcome was risk of fetal death or death of liveborn infant before discharge or serious infant outcome. Data were analysed for the 2,345 women (100%) and infants enrolled.
The risk of fetal death or liveborn infant death prior to discharge or serious infant outcome was significantly lower for infants born in the planned ERC group compared with infants in the planned VBAC group (0.9% versus 2.4%; relative risk [RR] 0.39; 95% CI 0.19–0.80; number needed to treat to benefit 66; 95% CI 40–200). Fewer women in the planned ERC group compared with women in the planned VBAC had a major haemorrhage (blood loss ≥1,500 ml and/or blood transfusion), (0.8% [9/1,108] versus 2.3% [29/1,237]; RR 0.37; 95% CI 0.17–0.80).
Conclusions
Among women with one prior caesarean, planned ERC compared with planned VBAC was associated with a lower risk of fetal and infant death or serious infant outcome. The risk of major maternal haemorrhage was reduced with no increase in maternal or perinatal complications to time of hospital discharge. Women, clinicians, and policy makers can use this information to develop health advice and make decisions about care for women who have had a previous caesarean.
