The impact of consent on observational research: a comparison of outcomes from consenters and non consenters to an observational study

Background Public health benefits from research often rely on the use of data from personal medical records. When neither patient consent nor anonymisation is possible, the case for accessing such records for research purposes depends on an assessment of the probabilities of public benefit and individual harm. Methods In the late 1990s, we carried out an observational study which compared the care given to affluent and deprived women with breast cancer. Patient consent was not required at that time for review of medical records, but was obtained later in the process prior to participation in the questionnaire study. We have re-analysed our original results to compare the whole sample with those who later provided consent. Results Two important findings emerged from the re-analysis of our data which if presented initially would have resulted in insufficient and inaccurate reporting. Firstly, the reduced dataset contains no information about women presenting with locally advanced or metastatic cancer and we would have been unable to demonstrate one of our initial key findings: namely a larger number of such women in the deprived group. Secondly, our re-analysis of the consented women shows that significantly more women from deprived areas (51 v 31%, p = 0.018) received radiotherapy compared to women from more affluent areas. Previously published data from the entire sample demonstrated no difference in radiotherapy treatment between the affluent and deprived groups. Conclusion The risk benefit assessment made regarding the use of medical records without consent should include the benefits of obtaining research evidence based on 100% of the population and the possibility of inappropriate or insufficient findings if research is confined to consented populations

Early breastfeeding practices: Descriptive analysis of recent Demographic and Health Surveys.

The aim of this study was to describe early breastfeeding practices (initiation within 1 hr of birth, no prelacteal feeding, and a combination of both-"optimal" early breastfeeding) according to childbirth location in low- and middle-income countries. Using data from the most recent Demographic and Health Survey (2000-2013) for 57 countries, we extracted information on the most recent birth for women aged 15-49 with a live birth in the preceding 24 months. Childbirth setting was self-reported by location (home or facility) and subtype (home delivery with or without a skilled birth attendant; public or private facility). We produced overall world and four region-level summary statistics by applying national population adjusted survey weights. Overall, 39% of children were breastfed within 1 hr of birth (region range 31-60%), 49% received no prelacteal feeding (41-65%), and 28% benefited from optimal early breastfeeding (21-46%). In South/Southeast Asia and Sub-Saharan Africa, early breastfeeding outcomes were more favourable for facility births compared to home births; trends were less consistent in Latin America and Middle East/Europe. Among home deliveries, there was a higher prevalence of positive breastfeeding practices for births with a skilled birth attendant across all regions other than Latin America. For facility births, breastfeeding practices were more favourable among those taking place in the public sector. This study is the most comprehensive assessment to date of early breastfeeding practices by childbirth location. Our results suggest that skilled delivery care-particularly care delivered in public sector facilities-appears positively correlated with favourable breastfeeding practices

Role of the private sector in childbirth care: cross-sectional survey evidence from 57 low- and middle-income countries using Demographic and Health Surveys.

OBJECTIVE: Maternal mortality rates have decreased globally but remain off track for Millennium Development Goals. Good-quality delivery care is one recognised strategy to address this gap. This study examines the role of the private (non-public) sector in providing delivery care and compares the equity and quality of the sectors. METHODS: The most recent Demographic and Health Survey (2000-2013) for 57 countries was used to analyse delivery care for most recent birth among >330 000 women. Wealth quintiles were used for equity analysis; skilled birth attendant (SBA) and Caesarean section rates served as proxies for quality of care in cross-sectoral comparisons. RESULTS: The proportion of women who used appropriate delivery care (non-facility with a SBA or facility-based births) varied across regions (49-84%), but wealth-related inequalities were seen in both sectors in all regions. One-fifth of all deliveries occurred in the private sector. Overall, 36% of deliveries with appropriate care occurred in the private sector, ranging from 9% to 46% across regions. The presence of a SBA was comparable between sectors (≥93%) in all regions. In every region, Caesarean section rate was higher in the private compared to public sector. The private sector provided between 13% (Latin America) and 66% (Asia) of Caesarean section deliveries. CONCLUSION: This study is the most comprehensive assessment to date of coverage, equity and quality indicators of delivery care by sector. The private sector provided a substantial proportion of delivery care in low- and middle-income countries. Further research is necessary to better understand this heterogeneous group of providers and their potential to equitably increase the coverage of good-quality intrapartum care

Who, What, Where: an analysis of private sector family planning provision in 57 low- and middle-income countries.

OBJECTIVE: Family planning service delivery has been neglected; rigorous analyses of the patterns of contraceptive provision are needed to inform strategies to address this neglect. METHODS: We used 57 nationally representative Demographic and Health Surveys in low- and middle-income countries (2000-2013) in four geographic regions to estimate need for contraceptive services, and examined the sector of provision, by women's socio-economic position. We also assessed method mix and whether women were informed of side effects. RESULTS: Modern contraceptive use among women in need was lowest in sub-Saharan Africa (39%), with other regions ranging from 64% to 72%. The private sector share of the family planning market was 37-39% of users across the regions and 37% overall (median across countries: 41%). Private sector users accessed medical providers (range across regions: 30-60%, overall mean: 54% and median across countries 23%), specialised drug sellers (range across regions: 31-52%, overall mean: 36% and median across countries: 43%) and retailers (range across regions: 3-14%, overall mean: 6% and median across countries: 6%). Private retailers played a more important role in sub-Saharan Africa (14%) than in other regions (3-5%). NGOs and FBOs served a small percentage. Privileged women (richest wealth quintile, urban residents or secondary-/tertiary-level education) used private sector services more than the less privileged. Contraceptive method types with higher requirements (medical skills) for provision were less likely to be acquired from the private sector, while short-acting methods/injectables were more likely. The percentages of women informed of side effects varied by method and provider subtype, but within subtypes were higher among public than private medical providers for four of five methods assessed. CONCLUSION: Given the importance of private sector providers, we need to understand why women choose their services, what quality services the private sector provides, and how it can be improved. However, when prioritising one of the two sectors (public vs. private), it is critical to consider the potential impact on contraceptive prevalence and equity of met need

Survey of the quality of experimental design, statistical analysis and reporting of research using animals

For scientific, ethical and economic reasons, experiments involving animals should be appropriately designed, correctly analysed and transparently reported. This increases the scientific validity of the results, and maximises the knowledge gained from each experiment. A minimum amount of relevant information must be included in scientific publications to ensure that the methods and results of a study can be reviewed, analysed and repeated. Omitting essential information can raise scientific and ethical concerns. We report the findings of a systematic survey of reporting, experimental design and statistical analysis in published biomedical research using laboratory animals. Medline and EMBASE were searched for studies reporting research on live rats, mice and non-human primates carried out in UK and US publicly funded research establishments. Detailed information was collected from 271 publications, about the objective or hypothesis of the study, the number, sex, age and/or weight of animals used, and experimental and statistical methods. Only 59% of the studies stated the hypothesis or objective of the study and the number and characteristics of the animals used. Appropriate and efficient experimental design is a critical component of high-quality science. Most of the papers surveyed did not use randomisation (87%) or blinding (86%), to reduce bias in animal selection and outcome assessment. Only 70% of the publications that used statistical methods described their methods and presented the results with a measure of error or variability. This survey has identified a number of issues that need to be addressed in order to improve experimental design and reporting in publications describing research using animals. Scientific publication is a powerful and important source of information; the authors of scientific publications therefore have a responsibility to describe their methods and results comprehensively, accurately and transparently, and peer reviewers and journal editors share the responsibility to ensure that published studies fulfil these criteria

Long-term Late Cretaceous oxygen-and carbonisotope trends and planktonic foraminiferal turnover: A new record from the southern midlatitudes

© 2016 Geological Society of America. The ~35-m.y.-long Late Cretaceous greenhouse climate has been the subject of a number of studies, with emphasis on the Cenomanian-Turonian and late Campanian-Maastrichtian intervals. By contrast, far less information is available for the Turonian-early Campanian interval, even though it encompasses the transition out of the extreme warmth of the Cenomanian-Turonian greenhouse climate optimum and includes an ~3-m.y.-long mid-Coniacian-mid-Santonian interval when planktonic foraminifera underwent a large-scale, but poorly understood, turnover. This study presents ~1350 δ18O and δ13C values of wellpreserved benthic and planktonic foraminifera and of the <63 μm size fraction from the Exmouth Plateau off Australia (eastern Indian Ocean). These data provide: (1) the most continuous, highly resolved, and stratigraphically well-constrained record of longterm trends in Late Cretaceous oxygen-and carbon-isotope ratios from the southern midlatitudes, and (2) new information on the paleoecological preferences of planktonic foraminiferal taxa. The results indicate persistent warmth from the early Turonian until the mid-Santonian, cooling from the mid-Santonian through the mid-Campanian, and short-term climatic variability during the late Campanian-Maastrichtian. Moreover, our results suggest the cause of Coniacian-Santonian turnover among planktonic foraminifera may have been the diversification of a temperature-and/or salinity-tolerant genus (Marginotruncana), and the cause of the Santonian-early Campanian extinction of Dicarinella and Marginotruncana may have been surface-ocean cooling and competition with globotruncanids

Systematic review and meta-analysis of the efficacy of interleukin-1 receptor antagonist in animal models of stroke: an update

Interleukin-1 receptor antagonist (IL-1 RA) is an anti-inflammatory protein used clinically to treat rheumatoid arthritis and is considered a promising candidate therapy for stroke. Here, we sought to update the existing systematic review and meta-analysis of IL-1 RA in models of ischaemic stroke, published in 2009, to assess efficacy, the range of circumstances in which efficacy has been tested and whether the data appear to be confounded due to reported study quality and publication bias. We included 25 sources of data, 11 of which were additional to the original review. Overall, IL-1 RA reduced infarct volume by 36.2 % (95 % confidence interval 31.6–40.7, n = 76 comparisons from 1283 animals). Assessments for publication bias suggest 30 theoretically missing studies which reduce efficacy to 21.9 % (17.3–26.4). Efficacy was higher where IL-1 RA was administered directly into the ventricles rather than peripherally, and studies not reporting allocation concealment during the induction of ischaemia reported larger treatment effects. The preclinical data supporting IL-1 RA as a candidate therapy for ischaemic stroke have improved. The reporting of measures to reduce the risk of bias has improved substantially in this update, and studies now include the use of animals with relevant co-morbidities. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1007/s12975-016-0489-z) contains supplementary material, which is available to authorized users

Systematic review and stratified meta-analysis of the efficacy of RhoA and Rho kinase inhibitors in animal models of ischaemic stroke

There is currently only one clinically approved drug, tissue plasminogen activator (tPA), for the treatment of acute ischaemic stroke. The RhoA pathway, including RhoA and its downstream effector Rho kinase (ROCK), has been identified as a possible therapeutic target. Our aim was to assess the impact of study design characteristics and study quality on reported measures of efficacy and to assess for the presence and impact of publication bias. We conducted a systematic review and meta-analysis on publications describing the efficacy of RhoA and ROCK inhibitors in animal models of focal cerebral ischaemia where outcome was assessed as a change in lesion size or neurobehavioural score, or both. We identified 25 published papers which met our inclusion criteria. RhoA and ROCK inhibitors reduced lesion size by 37.3% in models of focal cerebral ischaemia (95% CI, 28.6% to 46.0%, 41 comparisons), and reduced neurobehavioural data by 40.5% (33.4% to 47.7%, 30 comparisons). Overall study quality was low (median=4, interquartile range 3-5) and measures to reduce bias were seldom reported. Publication bias was prevalent and associated with a substantial overstatement of efficacy for lesion size. RhoA and ROCK inhibitors appear to be effective in animal models of stroke. However the low quality score, publication bias and limited number of studies are areas which need attention prior to conducting clinical trials