Labour induction at term - a randomised trial comparing Foley catheter plus titrated oral misoprostol solution, titrated oral misoprostol solution alone, and dinoprostone

Objectives. To compare three methods of labour induction.Design. Randomised controlled trial.Setting. Academic hospitals in Johannesburg, South Africa.Subjects. Women with intact membranes due for induction of labour.Method. Randomised, sealed opaque envelopes were used to allocate women to labour induction with extra-amniotic Foley catheter/titrated oral misoprostol solution (N = 174), titrated oral misoprostol solution alone (N = 176), or vaginal dinoprostone (N = 176). Misoprostol was dissolved in water and 20 - 40 g was given 2-hourly.Outcome measures. These were failure to deliver vaginally within 24 hours, additional measures for induction or augmentation of labour, analgesia, and maternal and fetal complications.                                                      Results. In the Foley catheter group, misoprostol was required in all but 1 case. Failure to deliver vaginally within 24 hours was similar for the three groups (79/174 v. 70/176 v. 70/176 respectively). Labour augmentation, caesarean section and instrumental delivery were used somewhat more frequently in the Foley /misoprostol group than in the misoprostol alone group, but these differences were not statistically significant. More analgesia was used in the Foley catheter/misoprostol group than in the misoprostol group (64/172 v. 46/175). Side effects and neonatal complications were similar for the three groups.Conclusions. Use of extra-amniotic Foley catheter placement showed no measurable benefits over the use of oral misoprostol alone, or vaginal dinoprostone.

An interprofessional approach to addressing inequalities experienced by health care students

Background: Students experience a range of inequalities within higher education institutions influenced by the intersectionality between socioeconomic, ethnicity, age and gender (House of Commons, 2023; Richardson, Mittelmeier and Rienties, 2020). It is imperative that higher education institutions are responsive to these challenges in order to create a more inclusive and equitable learning environment which will enhance the student experience and enable them to thrive in their onward health care professions. Aim: The aim of this study is to investigate the relationship between socioeconomic, ethnicity, age and gender in the context of student’s educational outcomes and social identification with university culture. Objective: To develop a framework that is co-created with students to support the EDI strategy within the school of health sciences. Methodology: A purposive sample of students registered on different health care professional programmes within the School of Health Sciences which include nursing, midwifery, paramedics, speech and language, physiotherapy and advanced clinical practice will be invited to participate. Through the lens of social identity theory (Tajfel and Turner, 1986), a mixed methods explanatory approach will be used. The first phase will be an online survey which will gather demographic details for example socioeconomic status, ethnicity, gender, and age. Measures will be used to collect data on educational outcomes and social identity. In the second phase, interprofessional focus groups will be conducted. These are aimed to develop a shared understanding of the experiences of students across the different health care professions and to co-create strategies that can be implemented to enhance their academic progression and sense of connectedness and belonging with university culture

Titrated oral misoprostol solution- a new method of labour induction

Background. Misoprostol, a cheap, stable, orally active prostaglandin analogue, is effective for labour induction when administered either vaginally or orally, but uterine hyperstimulation and rupture have been reported. Previous studies of oral misoprostol for labour induction have used fixed dosages 3 - 6-hourly.Objectives. To develop a new method of misoprostol use for labour induction using very small, frequent, titrated oral dosages, and to pilot effectiveness.Study design. Open clinical pilot study.Setting. Coronation Hospital, an academic hospital in Johannesburg, South Africa.Methods. We developed a method using 2-hourly titrated misoprostol doses commencing with 20 μg, increased after three doses to 40 μg. To administer such small doses we dissolved one rnisoprostol tablet in 200 ml water. A pilot study of this method was undertaken in 25 women with various indications for induction of labour.Results. Eighteen women (72%) delivered vaginally within 32 hours of induction and two women developed uterine hyperstirnulation. The caesarean section rate was 20%.Conclusions. Women may respond to much smaller dosages of misoprostol than are currently in use. A multicentre randomised trial of this method is underway. We emphasise the dangers inherent in the current unregistered use of misoprostol in clinical practice

Which method is best for the induction of labour?: A systematic review, network meta-analysis and cost-effectiveness analysis

Background: More than 150,000 pregnant women in England and Wales have their labour induced each year. Multiple pharmacological, mechanical and complementary methods are available to induce labour. Objective: To assess the relative effectiveness, safety and cost-effectiveness of labour induction methods and, data permitting, effects in different clinical subgroups. Methods: We carried out a systematic review using Cochrane methods. The Cochrane Pregnancy and Childbirth Group’s Trials Register was searched (March 2014). This contains over 22,000 reports of controlled trials (published from 1923 onwards) retrieved from weekly searches of OVID MEDLINE (1966 to current); Cochrane Central Register of Controlled Trials (The Cochrane Library); EMBASE (1982 to current); Cumulative Index to Nursing and Allied Health Literature (1984 to current); ClinicalTrials.gov; the World Health Organization International Clinical Trials Registry Portal; and hand-searching of relevant conference proceedings and journals. We included randomised controlled trials examining interventions to induce labour compared with placebo, no treatment or other interventions in women eligible for third-trimester induction. We included outcomes relating to efficacy, safety and acceptability to women. In addition, for the economic analysis we searched the Database of Abstracts of Reviews of Effects, and Economic Evaluations Databases, NHS Economic Evaluation Database and the Health Technology Assessment database. We carried out a network meta-analysis (NMA) using all of the available evidence, both direct and indirect, to produce estimates of the relative effects of each treatment compared with others in a network. We developed a de novo decision tree model to estimate the cost-effectiveness of various methods. The costs included were the intervention and other hospital costs incurred (price year 2012–13). We reviewed the literature to identify preference-based utilities for the health-related outcomes in the model. We calculated incremental cost-effectiveness ratios, expected costs, utilities and net benefit. We represent uncertainty in the optimal intervention using cost-effectiveness acceptability curves. Results: We identified 1190 studies; 611 were eligible for inclusion. The interventions most likely to achieve vaginal delivery (VD) within 24 hours were intravenous oxytocin with amniotomy [posterior rank 2; 95% credible intervals (CrIs) 1 to 9] and higher-dose (≥ 50 μg) vaginal misoprostol (rank 3; 95% CrI 1 to 6). Compared with placebo, several treatments reduced the odds of caesarean section, but we observed considerable uncertainty in treatment rankings. For uterine hyperstimulation, double-balloon catheter had the highest probability of being among the best three treatments, whereas vaginal misoprostol (≥ 50 μg) was most likely to increase the odds of excessive uterine activity. For other safety outcomes there were insufficient data or there was too much uncertainty to identify which treatments performed ‘best’. Few studies collected information on women’s views. Owing to incomplete reporting of the VD within 24 hours outcome, the cost-effectiveness analysis could compare only 20 interventions. The analysis suggested that most interventions have similar utility and differ mainly in cost. With a caveat of considerable uncertainty, titrated (low-dose) misoprostol solution and buccal/sublingual misoprostol had the highest likelihood of being cost-effective. Limitations: There was considerable uncertainty in findings and there were insufficient data for some planned subgroup analyses. Conclusions: Overall, misoprostol and oxytocin with amniotomy (for women with favourable cervix) is more successful than other agents in achieving VD within 24 hours. The ranking according to safety of different methods was less clear. The cost-effectiveness analysis suggested that titrated (low-dose) oral misoprostol solution resulted in the highest utility, whereas buccal/sublingual misoprostol had the lowest cost. There was a high degree of uncertainty as to the most cost-effective intervention

Independent and combined effects of improved water, sanitation, and hygiene, and improved complementary feeding, on child stunting and anaemia in rural Zimbabwe: a cluster-randomised trial.

BACKGROUND: Child stunting reduces survival and impairs neurodevelopment. We tested the independent and combined effects of improved water, sanitation, and hygiene (WASH), and improved infant and young child feeding (IYCF) on stunting and anaemia in in Zimbabwe. METHODS: We did a cluster-randomised, community-based, 2 × 2 factorial trial in two rural districts in Zimbabwe. Clusters were defined as the catchment area of between one and four village health workers employed by the Zimbabwe Ministry of Health and Child Care. Women were eligible for inclusion if they permanently lived in clusters and were confirmed pregnant. Clusters were randomly assigned (1:1:1:1) to standard of care (52 clusters), IYCF (20 g of a small-quantity lipid-based nutrient supplement per day from age 6 to 18 months plus complementary feeding counselling; 53 clusters), WASH (construction of a ventilated improved pit latrine, provision of two handwashing stations, liquid soap, chlorine, and play space plus hygiene counselling; 53 clusters), or IYCF plus WASH (53 clusters). A constrained randomisation technique was used to achieve balance across the groups for 14 variables related to geography, demography, water access, and community-level sanitation coverage. Masking of participants and fieldworkers was not possible. The primary outcomes were infant length-for-age Z score and haemoglobin concentrations at 18 months of age among children born to mothers who were HIV negative during pregnancy. These outcomes were analysed in the intention-to-treat population. We estimated the effects of the interventions by comparing the two IYCF groups with the two non-IYCF groups and the two WASH groups with the two non-WASH groups, except for outcomes that had an important statistical interaction between the interventions. This trial is registered with ClinicalTrials.gov, number NCT01824940. FINDINGS: Between Nov 22, 2012, and March 27, 2015, 5280 pregnant women were enrolled from 211 clusters. 3686 children born to HIV-negative mothers were assessed at age 18 months (884 in the standard of care group from 52 clusters, 893 in the IYCF group from 53 clusters, 918 in the WASH group from 53 clusters, and 991 in the IYCF plus WASH group from 51 clusters). In the IYCF intervention groups, the mean length-for-age Z score was 0·16 (95% CI 0·08-0·23) higher and the mean haemoglobin concentration was 2·03 g/L (1·28-2·79) higher than those in the non-IYCF intervention groups. The IYCF intervention reduced the number of stunted children from 620 (35%) of 1792 to 514 (27%) of 1879, and the number of children with anaemia from 245 (13·9%) of 1759 to 193 (10·5%) of 1845. The WASH intervention had no effect on either primary outcome. Neither intervention reduced the prevalence of diarrhoea at 12 or 18 months. No trial-related serious adverse events, and only three trial-related adverse events, were reported. INTERPRETATION: Household-level elementary WASH interventions implemented in rural areas in low-income countries are unlikely to reduce stunting or anaemia and might not reduce diarrhoea. Implementation of these WASH interventions in combination with IYCF interventions is unlikely to reduce stunting or anaemia more than implementation of IYCF alone. FUNDING: Bill & Melinda Gates Foundation, UK Department for International Development, Wellcome Trust, Swiss Development Cooperation, UNICEF, and US National Institutes of Health.The SHINE trial is funded by the Bill & Melinda Gates Foundation (OPP1021542 and OPP113707); UK Department for International Development; Wellcome Trust, UK (093768/Z/10/Z, 108065/Z/15/Z and 203905/Z/16/Z); Swiss Agency for Development and Cooperation; US National Institutes of Health (2R01HD060338-06); and UNICEF (PCA-2017-0002)

Methodological procedures for priority setting mental health research: A systematic review summarising the methods, designs and frameworks involved with priority setting

Background Research priority setting aims to identify research gaps within particular health fields. Given the global burden of mental illness and underfunding of mental health research compared to other health topics, knowledge of methodological procedures may raise the quality of priority setting to identify research with value and impact. However, to date there has been no comprehensive review on the approaches adopted with priority setting projects that identify mental health research, despite viewed as essential knowledge to address research gaps. Hence, the paper presents a summary of the methods, designs, and existing frameworks that can be adopted for prioritising mental health research to inform future prioritising projects. Method A systematic review of electronic databases located prioritisation literature, while a critical interpretive synthesis was adopted whereby the appraisal of methodological procedures was integrated into the synthesis of the findings. The synthesis was shaped using the good practice checklist for priority setting by Viergever and colleagues drawing on their following categories to identify and appraise methodological procedures: (1) Comprehensive Approach – frameworks/designs guiding the entire priority setting; (2) Inclusiveness –participation methods to aid the equal contribution of stakeholders; (3) Information Gathering – data collecting methods to identify research gaps, and (4) Deciding Priorities - methods to finalise priorities. Results In total 903 papers were located with 889 papers removed as either duplicates or not meeting the inclusion and exclusion criteria. 14 papers were identified, describing 13 separate priority setting projects. Participatory approaches were the dominant method adopted but existing prioritisation frameworks were modified with little explanation regarding the rationale, processes for adaptation and theoretical foundation. Processes were predominately researcher led, although with some patient involvement. Surveys and consensus building methods gathered information while ranking systems and thematic analysis tend to generate finalised priorities. However, limited evidence found about transforming priorities into actual research projects and few described plans for implementation to promote translation into user-informed research. Conclusion Prioritisation projects may benefit from justifying the methodological approaches taken to identify mental health research, stating reasons for adapting frameworks alongside reasons for adopting particular methods, while finalised priorities should be worded in such a way as to facilitate their easy translation into research projects

Methodological procedures for priority setting mental health research:a systematic review summarising the methods, designs and frameworks involved with priority setting

Background Research priority setting aims to identify research gaps within particular health fields. Given the global burden of mental illness and underfunding of mental health research compared to other health topics, knowledge of methodological procedures may raise the quality of priority setting to identify research with value and impact. However, to date there has been no comprehensive review on the approaches adopted with priority setting projects that identify mental health research, despite viewed as essential knowledge to address research gaps. Hence, the paper presents a summary of the methods, designs, and existing frameworks that can be adopted for prioritising mental health research to inform future prioritising projects. Method A systematic review of electronic databases located prioritisation literature, while a critical interpretive synthesis was adopted whereby the appraisal of methodological procedures was integrated into the synthesis of the findings. The synthesis was shaped using the good practice checklist for priority setting by Viergever and colleagues drawing on their following categories to identify and appraise methodological procedures: (1) Comprehensive Approach—frameworks/designs guiding the entire priority setting; (2) Inclusiveness –participation methods to aid the equal contribution of stakeholders; (3) Information Gatherin —data collecting methods to identify research gaps, and (4) Deciding Priorities—methods to finalise priorities. Results In total 903 papers were located with 889 papers removed as either duplicates or not meeting the inclusion and exclusion criteria. 14 papers were identified, describing 13 separate priority setting projects. Participatory approaches were the dominant method adopted but existing prioritisation frameworks were modified with little explanation regarding the rationale, processes for adaptation and theoretical foundation. Processes were predominately researcher led, although with some patient involvement. Surveys and consensus building methods gathered information while ranking systems and thematic analysis tend to generate finalised priorities. However, limited evidence found about transforming priorities into actual research projects and few described plans for implementation to promote translation into user-informed research. Conclusion Prioritisation projects may benefit from justifying the methodological approaches taken to identify mental health research, stating reasons for adapting frameworks alongside reasons for adopting particular methods, while finalised priorities should be worded in such a way as to facilitate their easy translation into research projects