Chilean midwives' experiences while providing induced abortion care after the enactment of a law decriminalising abortion.

INTRODUCTION: The recent change in Chilean legislation towards abortion enabled midwives to include the care of women having an induced abortion within their scope of practice. However, midwives' identity could be strained by induced abortion care provision as it is contrary to midwives' traditional role. Considering this, the aim of the study was to elucidate how Chilean midwives understand and provide abortion care. METHODS: A constructivist grounded theory study was conducted using online semi-structured in-depth interviews. Midwives were purposively sampled considering maximum variation criteria and then theoretical sampling occurred. Saturation was achieved with fifteen interviews. Interviews were conducted in Spanish and then translated into English. Constant comparison analysis generated categories. Data were managed using NVivo 12. All interviewees provided their consent to be part of this study. RESULTS: This article reports on the experiences of nine midwives who had provided lawful induced abortion care in Chile. The experiences of these midwives were grouped into two major categories: 'Defining a position towards abortion' and 'Abortion care is emotional labour'. CONCLUSION: Midwives can successfully provide abortion care despite being challenged by certain areas of it. Considering the high demand for emotional labour in abortion care, efforts should be made to increase midwives' emotional self-regulation skills. Likewise, organisations should strengthen and implement their offer of well-being and emotional self-care support to midwives.

Navigating a maze: Midwives' identity response to the enactment of an abortion law in Chile.

BACKGROUND: Chilean midwives have been identified as essential for successfully implementing an abortion law, a practice which could potentially be understood as contradicting their central mission. Nevertheless, to date, there has been no investigation into how Chilean midwives have incorporated induced abortion care provision into their professional identity. OBJECTIVE: To elucidate how Chilean midwives understand and provide abortion care and how they have (re)defined their professional identity to include induced abortion care. This article reports the findings of the second part of this aim. METHODS: This study was underpinned by a constructivist grounded theory methodology informed by a reproductive justice and feminist perspective. Midwives from Chile who have cared for women undergoing abortion were invited to participate in the study. After purposive and theoretical sampling, fifteen midwives were recruited. FINDINGS: Midwives' identity is woman-centred, with high value placed on their role protecting life. These two aspects of midwives' identity are in contradiction when providing abortion care. Midwives' identity results from and informs midwives' practice. Midwifery regulation influences both practice and identity. The model 'Navigating a maze' explains the interaction of these three elements. CONCLUSION: Midwives' identity response to the enactment of the Chilean abortion law is an example of how professional identity must navigate regulation and practice to make sense of its purpose. In light of this study's findings, the current tension experienced in midwives' identity should be carefully attended to prevent adverse outcomes for midwives and the Chilean population.

Investigating the impact of London's ultra low emission zone on children's health: children's health in London and Luton (CHILL) protocol for a prospective parallel cohort study.

BACKGROUND: Air pollution harms health across the life course. Children are at particular risk of adverse effects during development, which may impact on health in later life. Interventions that improve air quality are urgently needed both to improve public health now, and prevent longer-term increased vulnerability to chronic disease. Low Emission Zones are a public health policy intervention aimed at reducing traffic-derived contributions to urban air pollution, but evidence that they deliver health benefits is lacking. We describe a natural experiment study (CHILL: Children's Health in London and Luton) to evaluate the impacts of the introduction of London's Ultra Low Emission Zone (ULEZ) on children's health. METHODS: CHILL is a prospective two-arm parallel longitudinal cohort study recruiting children at age 6-9 years from primary schools in Central London (the focus of the first phase of the ULEZ) and Luton (a comparator site), with the primary outcome being the impact of changes in annual air pollutant exposures (nitrogen oxides [NOx], nitrogen dioxide [NO2], particulate matter with a diameter of less than 2.5micrograms [PM2.5], and less than 10 micrograms [PM10]) across the two sites on lung function growth, measured as post-bronchodilator forced expiratory volume in one second (FEV1) over five years. Secondary outcomes include physical activity, cognitive development, mental health, quality of life, health inequalities, and a range of respiratory and health economic data. DISCUSSION: CHILL's prospective parallel cohort design will enable robust conclusions to be drawn on the effectiveness of the ULEZ at improving air quality and delivering improvements in children's respiratory health. With increasing proportions of the world's population now living in large urban areas exceeding World Health Organisation air pollution limit guidelines, our study findings will have important implications for the design and implementation of Low Emission and Clean Air Zones in the UK, and worldwide. CLINICALTRIALS: GOV: NCT04695093 (05/01/2021).

Fluid Optimisation in Emergency Laparotomy (FLO-ELA) Trial: study protocol for a multi-centre randomised trial of cardiac output-guided fluid therapy compared to usual care in patients undergoing major emergency gastrointestinal surgery.

INTRODUCTION: Postoperative morbidity and mortality in patients undergoing major emergency gastrointestinal surgery are a major burden on healthcare systems. Optimal management of perioperative intravenous fluids may reduce mortality rates and improve outcomes from surgery. Previous small trials of cardiac-output guided haemodynamic therapy algorithms in patients undergoing gastrointestinal surgery have suggested this intervention results in reduced complications and a modest reduction in mortality. However, this existing evidence is based mainly on elective (planned) surgery, with little evaluation in the emergency setting. There are fundamental clinical and pathophysiological differences between the planned and emergency surgical setting which may influence the effects of this intervention. A large definitive trial in emergency surgery is needed to confirm or refute the potential benefits observed in elective surgery and to inform widespread clinical practice. METHODS: The FLO-ELA trial is a multi-centre, parallel-group, open, randomised controlled trial. 3138 patients aged 50 and over undergoing major emergency gastrointestinal surgery will be randomly allocated in a 1:1 ratio using minimisation to minimally invasive cardiac output monitoring to guide protocolised administration of intra-venous fluid, or usual care without cardiac output monitoring. The trial intervention will be carried out during surgery and for up to 6 h postoperatively. The trial is funded through an efficient design call by the National Institute for Health and Care Research Health Technology Assessment (NIHR HTA) programme and uses existing routinely collected datasets for the majority of data collection. The primary outcome is the number of days alive and out of hospital within 90 days of randomisation. Participants and those delivering the intervention will not be blinded to treatment allocation. Participant recruitment started in September 2017 with a 1-year internal pilot phase and is ongoing at the time of publication. DISCUSSION: This will be the largest contemporary randomised trial examining the effectiveness of perioperative cardiac output-guided haemodynamic therapy in patients undergoing major emergency gastrointestinal surgery. The multi-centre design and broad inclusion criteria support the external validity of the trial. Although the clinical teams delivering the trial interventions will not be blinded, significant trial outcome measures are objective and not subject to detection bias. TRIAL REGISTRATION: ISRCTN 14729158. Registered on 02 May 2017.

Experiences of midwives and nurses when implementing abortion policies: A systematic integrative review.

INTRODUCTION: Policy implementation can be affected by what individuals believe to be right and wrong. When implementing abortion policies, providers' moral beliefs can be relevant in the success of the implementation process. Considering that midwives and nurses are direct providers of abortion care, exploring their experiences related to abortion policy implementation could provide helpful information to prevent policy failure. METHODS: Systematic integrative review. The studies were identified through an electronic search strategy and the screening of the reference lists of all selected articles. Studies were retrieved from eight medical and social sciences databases. Thirty-one studies focused on midwives' and nurses' experiences of implementing abortion policies, irrespective of setting or age of study were included in this review. Studies included used qualitative, quantitative and mixed methods. Study quality was appraised using the Mixed Method Appraisal Tool version 2018. No study was excluded from this review based on its quality appraisal. RESULTS: In terms of their quality, most studies included in this review were conducted appropriately. Three superordinate themes represent the main elements that challenge midwives and nurses when providing abortion care. The first superordinate theme identified that many midwives and nurses believed fetuses are sentient beings, making them worthy of compassionate treatment. The next superordinate theme was focused on preferences and expectations about abortion care. Finally, the third superordinate theme illustrates midwives' and nurses' experiences with other team members, highlights their creativity when challenged with insufficient resources and provides a glimpse of the numerous techniques used for coping with work-related stress. CONCLUSION: Midwives and nurses worldwide face multiple challenges when providing abortion care. Guidelines aiming to support policy implementation should consider how abortion affects healthcare providers and suggest appropriate measures to reduce these and other barriers. Midwives and nurses technical and ethical competencies for abortion provision should be strengthened.

Use of a Research as Intervention Approach to Explore Telebehavioral Health Services During the COVID-19 Pandemic in Southeastern Idaho.

INTRODUCTION: Since the inception of the COVID-19 pandemic, telebehavioral health services have been a key contributor to continuation of care in rural and underserved areas of southeastern Idaho. Providers of telebehavioral health services faced numerous challenges as they navigated rapidly shifting regulations, variable access to internet and their own personal understandings of practice. OBJECTIVE: This study aimed to characterize provider experiences, generate policy- and practice-level recommendations, and raise awareness among community stakeholders regarding telebehavioral health in southeastern Idaho. METHODS: Using a newly developed conceptual/analytical framework, a research-as-intervention strategy was employed to conduct and analyze semi-structured interviews, short writings, and photographs from 7 primary care and behavioral health providers in the region. RESULTS: Providers shared examples from practice that addressed technology and training, access-to-care, safety, changing provider roles, payment for services, treatments that are not well suited to telehealth and the nuances of living and working in newly forged spaces of care. CONCLUSIONS: Providers found promise in telebehavioral health's utility as a hybrid model of care, but it must be supported by flexible legislation and policy. For example, it would help to make reimbursement expansions permanent and to simplify inter-jurisdictional practice options. Cross-sharing of information between licensing boards could help providers from various disciplines understand the parameters within which their colleagues must work.

Effectiveness of a national quality improvement programme to improve survival after emergency abdominal surgery (EPOCH): a stepped-wedge cluster-randomised trial.

BACKGROUND: Emergency abdominal surgery is associated with poor patient outcomes. We studied the effectiveness of a national quality improvement (QI) programme to implement a care pathway to improve survival for these patients. METHODS: We did a stepped-wedge cluster-randomised trial of patients aged 40 years or older undergoing emergency open major abdominal surgery. Eligible UK National Health Service (NHS) hospitals (those that had an emergency general surgical service, a substantial volume of emergency abdominal surgery cases, and contributed data to the National Emergency Laparotomy Audit) were organised into 15 geographical clusters and commenced the QI programme in a random order, based on a computer-generated random sequence, over an 85-week period with one geographical cluster commencing the intervention every 5 weeks from the second to the 16th time period. Patients were masked to the study group, but it was not possible to mask hospital staff or investigators. The primary outcome measure was mortality within 90 days of surgery. Analyses were done on an intention-to-treat basis. This study is registered with the ISRCTN registry, number ISRCTN80682973. FINDINGS: Treatment took place between March 3, 2014, and Oct 19, 2015. 22 754 patients were assessed for elegibility. Of 15 873 eligible patients from 93 NHS hospitals, primary outcome data were analysed for 8482 patients in the usual care group and 7374 in the QI group. Eight patients in the usual care group and nine patients in the QI group were not included in the analysis because of missing primary outcome data. The primary outcome of 90-day mortality occurred in 1210 (16%) patients in the QI group compared with 1393 (16%) patients in the usual care group (HR 1·11, 0·96-1·28). INTERPRETATION: No survival benefit was observed from this QI programme to implement a care pathway for patients undergoing emergency abdominal surgery. Future QI programmes should ensure that teams have both the time and resources needed to improve patient care. FUNDING: National Institute for Health Research Health Services and Delivery Research Programme.

Optimisation of Perioperative Cardiovascular Management to Improve Surgical Outcome II (OPTIMISE II) trial: study protocol for a multicentre international trial of cardiac output-guided fluid therapy with low-dose inotrope infusion compared with usual care in patients undergoing major elective gastrointestinal surgery.

INTRODUCTION: Postoperative morbidity and mortality in older patients with comorbidities undergoing gastrointestinal surgery are a major burden on healthcare systems. Infections after surgery are common in such patients, prolonging hospitalisation and reducing postoperative short-term and long-term survival. Optimal management of perioperative intravenous fluids and inotropic drugs may reduce infection rates and improve outcomes from surgery. Previous small trials of cardiac-output-guided haemodynamic therapy algorithms suggested a modest reduction in postoperative morbidity. A large definitive trial is needed to confirm or refute this and inform widespread clinical practice. METHODS: The Optimisation of Perioperative Cardiovascular Management to Improve Surgical Outcome II (OPTIMISE II) trial is a multicentre, international, parallel group, open, randomised controlled trial. 2502 high-risk patients undergoing major elective gastrointestinal surgery will be randomly allocated in a 1:1 ratio using minimisation to minimally invasive cardiac output monitoring to guide protocolised administration of intravenous fluid combined with low-dose inotrope infusion, or usual care. The trial intervention will be carried out during and for 4 hours after surgery. The primary outcome is postoperative infection of Clavien-Dindo grade II or higher within 30 days of randomisation. Participants and those delivering the intervention will not be blinded to treatment allocation; however, outcome assessors will be blinded when feasible. Participant recruitment started in January 2017 and is scheduled to last 3 years, within 50 hospitals worldwide. ETHICS/DISSEMINATION: The OPTIMISE II trial has been approved by the UK National Research Ethics Service and has been approved by responsible ethics committees in all participating countries. The findings will be disseminated through publication in a widely accessible peer-reviewed scientific journal. TRIAL REGISTRATION NUMBER: ISRCTN39653756.

The clinical effectiveness of different surveillance strategies to prevent colorectal cancer in people with intermediate-grade colorectal adenomas: a retrospective cohort analysis, and psychological and economic evaluations.

BACKGROUND: The UK guideline recommends 3-yearly surveillance for patients with intermediate-risk (IR) adenomas. No study has examined whether or not this group has heterogeneity in surveillance needs. OBJECTIVES: To examine the effect of surveillance on colorectal cancer (CRC) incidence; assess heterogeneity in risk; and identify the optimum frequency of surveillance, the psychological impact of surveillance, and the cost-effectiveness of alternative follow-up strategies. DESIGN: Retrospective multicentre cohort study. SETTING: Routine endoscopy and pathology data from 17 UK hospitals (n = 11,944), and a screening data set comprising three pooled cohorts (n = 2352), followed up using cancer registries. SUBJECTS: Patients with IR adenoma(s) (three or four small adenomas or one or two large adenomas). PRIMARY OUTCOMES: Advanced adenoma (AA) and CRC detected at follow-up visits, and CRC incidence after baseline and first follow-up. METHODS: The effects of surveillance on long-term CRC incidence and of interval length on findings at follow-up were examined using proportional hazards and logistic regression, adjusting for patient, procedural and polyp characteristics. Lower-intermediate-risk (LIR) subgroups and higher-intermediate-risk (HIR) subgroups were defined, based on predictors of CRC risk. A model-based cost-utility analysis compared 13 surveillance strategies. Between-group analyses of variance were used to test for differences in bowel cancer worry between screening outcome groups (n = 35,700). A limitation of using routine hospital data is the potential for missed examinations and underestimation of the effect of interval and surveillance. RESULTS: In the hospital data set, 168 CRCs occurred during 81,442 person-years (pys) of follow-up [206 per 100,000 pys, 95% confidence interval (CI) 177 to 240 pys]. One surveillance significantly lowered CRC incidence, both overall [hazard ratio (HR) 0.51, 95% CI 0.34 to 0.77] and in the HIR subgroup (n = 9265; HR 0.50, 95% CI 0.34 to 0.76). In the LIR subgroup (n = 2679) the benefit of surveillance was less clear (HR 0.62, 95% CI 0.16 to 2.43). Additional surveillance lowered CRC risk in the HIR subgroup by a further 15% (HR 0.36, 95% CI 0.20 to 0.62). The odds of detecting AA and CRC at first follow-up (FUV1) increased by 18% [odds ratio (OR) 1.18, 95% CI 1.12 to 1.24] and 32% (OR 1.32, 95% CI 1.20 to 1.46) per year increase in interval, respectively, and the odds of advanced neoplasia at second follow-up increased by 22% (OR 1.22, 95% CI 1.09 to 1.36), after adjustment. Detection rates of AA and CRC remained below 10% and 1%, respectively, with intervals to 3 years. In the screening data set, 32 CRCs occurred during 25,745 pys of follow-up (124 per 100,000 pys, 95% CI 88 to 176 pys). One follow-up conferred a significant 73% reduction in CRC incidence (HR 0.27, 95% CI 0.10 to 0.71). Owing to the small number of end points in this data set, no other outcome was significant. Although post-screening bowel cancer worry was higher in people who were offered surveillance, worry was due to polyp detection rather than surveillance. The economic evaluation, using data from the hospital data set, suggested that 3-yearly colonoscopic surveillance without an age cut-off would produce the greatest health gain. CONCLUSIONS: A single surveillance benefited all IR patients by lowering their CRC risk. We identified a higher-risk subgroup that benefited from further surveillance, and a lower-risk subgroup that may require only one follow-up. A surveillance interval of 3 years seems suitable for most IR patients. These findings should be validated in other studies to confirm whether or not one surveillance visit provides adequate protection for the lower-risk subgroup of intermediate-risk patients. STUDY REGISTRATION: Current Controlled Trials ISRCTN15213649. FUNDING: The National Institute for Health Research Health Technology Assessment programme.

Adenoma surveillance and colorectal cancer incidence: a retrospective, multicentre, cohort study.

BACKGROUND: Removal of adenomas reduces colorectal cancer incidence and mortality; however, the benefit of surveillance colonoscopy on colorectal cancer risk remains unclear. We examined heterogeneity in colorectal cancer incidence in intermediate-risk patients and the effect of surveillance on colorectal cancer incidence. METHODS: We did this retrospective, multicentre, cohort study using routine lower gastrointestinal endoscopy and pathology data from patients who, after baseline colonoscopy and polypectomy, were diagnosed with intermediate-risk adenomas mostly (>99%) between Jan 1, 1990, and Dec 31, 2010, at 17 hospitals in the UK. These patients are currently offered surveillance colonoscopy at intervals of 3 years. Patients were followed up through to Dec 31, 2014.We assessed the effect of surveillance on colorectal cancer incidence using Cox regression with adjustment for patient, procedural, and polyp characteristics. We defined lower-risk and higher-risk subgroups on the basis of polyp and procedural characteristics identified as colorectal cancer risk factors. We estimated colorectal cancer incidence and standardised incidence ratios (SIRs) using as standard the general population of England in 2007. This trial is registered, number ISRCTN15213649. FINDINGS: 253 798 patients who underwent colonic endoscopy were identified, of whom 11 944 with intermediate-risk adenomas were included in this analysis. After a median follow-up of 7·9 years (IQR 5·6-11·1), 210 colorectal cancers were diagnosed. 5019 (42%) patients did not attend surveillance and 6925 (58%) attended one or more surveillance visits. Compared to no surveillance, one or two surveillance visits were associated with a significant reduction in colorectal cancer incidence rate (adjusted hazard ratio 0·57, 95% CI 0·40-0·80 for one visit; 0·51, 0·31-0·84 for two visits). Without surveillance, colorectal cancer incidence in patients with a suboptimal quality colonoscopy, proximal polyps, or a high-grade or large adenoma (≥20 mm) at baseline (8865 [74%] patients) was significantly higher than in the general population (SIR 1·30, 95% CI 1·06-1·57). By contrast, in patients without these features, colorectal cancer incidence was lower than that of the general population (SIR 0·51, 95% CI 0·29-0·84). INTERPRETATION: Colonoscopy surveillance benefits most patients with intermediate-risk adenomas. However, some patients are already at low risk after baseline colonoscopy and the value of surveillance for them is unclear. FUNDING: National Institute for Health Research Health Technology Assessment, Cancer Research UK.

Extended and standard duration weight-loss programme referrals for adults in primary care (WRAP): a randomised controlled trial.

BACKGROUND: Evidence exist that primary care referral to an open-group behavioural programme is an effective strategy for management of obesity, but little evidence on optimal intervention duration is available. We aimed to establish whether 52-week referral to an open-group weight-management programme would achieve greater weight loss and improvements in a range of health outcomes and be more cost-effective than the current practice of 12-week referrals. METHODS: In this non-blinded, parallel-group, randomised controlled trial, we recruited participants who were aged 18 years or older and had body-mass index (BMI) of 28 kg/m2 or higher from 23 primary care practices in England. Participants were randomly assigned (2:5:5) to brief advice and self-help materials, a weight-management programme (Weight Watchers) for 12 weeks, or the same weight-management programme for 52 weeks. We followed-up participants over 2 years. The primary outcome was weight at 1 year of follow-up, analysed with mixed-effects models according to intention-to-treat principles and adjusted for centre and baseline weight. In a hierarchical closed-testing procedure, we compared combined behavioural programme arms with brief intervention, then compared the 12-week programme and 52-week programme. We did a within-trial cost-effectiveness analysis using person-level data and modelled outcomes over a 25-year time horizon using microsimulation. This study is registered with Current Controlled Trials, number ISRCTN82857232. FINDINGS: Between Oct 18, 2012, and Feb 10, 2014, we enrolled 1269 participants. 1267 eligible participants were randomly assigned to the brief intervention (n=211), the 12-week programme (n=528), and the 52-week programme (n=528). Two participants in the 12-week programme had been found to be ineligible shortly after randomisation and were excluded from the analysis. 823 (65%) of 1267 participants completed an assessment at 1 year and 856 (68%) participants at 2 years. All eligible participants were included in the analyses. At 1 year, mean weight changes in the groups were -3·26 kg (brief intervention), -4·75 kg (12-week programme), and -6·76 kg (52-week programme). Participants in the behavioural programme lost more weight than those in the brief intervention (adjusted difference -2·71 kg, 95% CI -3·86 to -1·55; p<0·0001). The 52-week programme was more effective than the 12-week programme (-2·14 kg, -3·05 to -1·22; p<0·0001). Differences between groups were still significant at 2 years. No adverse events related to the intervention were reported. Over 2 years, the incremental cost-effectiveness ratio (ICER; compared with brief intervention) was £159 per kg lost for the 52-week programme and £91 per kg for the 12-week programme. Modelled over 25 years after baseline, the ICER for the 12-week programme was dominant compared with the brief intervention. The ICER for the 52-week programme was cost-effective compared with the brief intervention (£2394 per quality-adjusted life-year [QALY]) and the 12-week programme (£3804 per QALY). INTERPRETATION: For adults with overweight or obesity, referral to this open-group behavioural weight-loss programme for at least 12 weeks is more effective than brief advice and self-help materials. A 52-week programme produces greater weight loss and other clinical benefits than a 12-week programme and, although it costs more, modelling suggests that the 52-week programme is cost-effective in the longer term. FUNDING: National Prevention Research Initiative, Weight Watchers International (as part of an UK Medical Research Council Industrial Collaboration Award).

An exploration of the effects of clinical negligence litigation on the practice of midwives in England: A phenomenological study.

OBJECTIVE: to explore how midwives׳ personal involvement in clinical negligence litigation affects their midwifery practice. DESIGN: descriptive phenomenological study using semi-structured interviews. SETTING: in 2006-2007 in-depth interviews were conducted in participants׳ homes or at their place of work and focused on participants׳ experience of litigation. Participants were recruited from various regions of England. PARTICIPANTS: 22 National Health Service (NHS) midwives who had been alleged negligent. FINDINGS: clinical practice affected was an increase in documentation, fear of practising outside clinical guidelines and electronic fetal monitoring of women at low obstetric risk; these changes were not widespread. Changes in practice were sometimes perceived negatively and sometimes positively. Forming a good relationship with childbearing women was judged to promote effective midwifery care but litigation had affected the ability of a minority of midwives to advocate for women if this relationship had not been established. Litigation could result in loss of confidence leading to self-doubt, isolation, increased readiness to seek medical assistance and avoidance of working in the labour ward, perceived as an area with a high risk of litigation. A blame culture in the NHS was perceived by several midwives. In contrast an open non-punitive culture resulted in midwives readily reporting mistakes to risk managers. Litigation lowered midwifery morale and damaged professional reputations, particularly when reported in the newspapers. Some midwives expressed thoughts of leaving midwifery or taking time off work because of litigation but only one was actively seeking other employment, another took sick leave and one had left midwifery and returned to nursing. KEY CONCLUSIONS: litigation can have a negative effect on midwives׳ clinical practice and morale and fosters a culture of blame within the NHS. IMPLICATIONS FOR PRACTICE: education regarding appropriate documentation, use or non-use of electronic fetal monitoring and the legal status of clinical guidelines will enable midwives to respond proportionately to the threat of litigation. A culture of openness and sharing the problem when adverse events occur would help to extinguish the current blame culture in the National Health Service. Litigation must be recognised by management as capable of inducing loss of confidence and reluctance to work in the labour ward. Promoting teamwork will help support these midwives. The potential for litigation in maternity care could affect retention of the midwifery workforce.

PIMS (Positioning In Macular hole Surgery) trial - a multicentre interventional comparative randomised controlled clinical trial comparing face-down positioning, with an inactive face-forward position on the outcome of surgery for large macular holes: study protocol for a randomised controlled trial.

BACKGROUND: Idiopathic macular holes are an important cause of blindness. They have an annual incidence of 8 per 100,000 individuals, and prevalence of 0.2 to 3.3 per 1000 individuals with visual impairment. The condition occurs more frequently in adults aged 75 years or older. Macular holes can be repaired by surgery in which the causative tractional forces in the eye are released and a temporary bubble of gas is injected. To promote successful hole closure individuals may be advised to maintain a face-down position for up to 10 days following surgery. The aim of this study is to determine whether advice to position face-down improves the surgical success rate of closure of large (>400 µm) macular holes, and thereby reduces the need for further surgery. METHODS/DESIGN: This will be a multicentre interventional, comparative randomised controlled clinical trial comparing face-down positioning with face-forward positioning. At the conclusion of standardised surgery across all sites, participants still eligible for inclusion will be allocated randomly 1:1 to 1 of the 2 treatment arms stratified by site, using random permuted blocks of size 4 or 6 in equal proportions. We will recruit 192 participants having surgery for large macular holes (>400 µm); 96 in each of the 2 arms of the study. The primary objective is to determine the impact of face-down positioning on the likelihood of closure of large (≥400 µm) full-thickness macular holes following surgery. DISCUSSION: This will be the first multicentre randomised control trial to investigate the value of face-down positioning following macular hole standardised surgery. TRIAL REGISTRATION: UK CRN: 17966 (date of registration 26 November 2014).

Weight loss referrals for adults in primary care (WRAP): protocol for a multi-centre randomised controlled trial comparing the clinical and cost-effectiveness of primary care referral to a commercial weight loss provider for 12 weeks, referral for 52 weeks, and a brief self-help intervention [ISRCTN82857232].

BACKGROUND: Recent trials demonstrate the acceptability and short term efficacy of primary care referral to a commercial weight loss provider for weight management. Commissioners now need information on the optimal duration of intervention and the longer term outcomes and cost effectiveness of such treatment to give best value for money. METHODS/DESIGN: This multicentre, randomised controlled trial with a parallel design will recruit 1200 overweight adults (BMI ≥28 kg/m2) through their primary care provider. They will be randomised in a 2:5:5 allocation to: Brief Intervention, Commercial Programme for 12 weeks, or Commercial Programme for 52 weeks. Participants will be followed up for two years, with assessments at 0, 3, 12 and 24 months. The sequential primary research questions are whether the CP interventions achieve significantly greater weight loss from baseline to 12 months than BI, and whether CP52 achieves significantly greater weight loss from baseline to 12 months than CP12. The primary outcomes will be an intention to treat analysis of between treatment differences in body weight at 12 months. Clinical effectiveness will be also be assessed by measures of weight, fat mass, and blood pressure at each time point and biochemical risk factors at 12 months. Self-report questionnaires will collect data on psychosocial factors associated with adherence, weight-loss and weight-loss maintenance. A within-trial and long-term cost-effectiveness analysis will be conducted from an NHS perspective. Qualitative methods will be used to examine the participant experience. DISCUSSION: The current trial compares the clinical and cost effectiveness of referral to a commercial provider with a brief intervention. This trial will specifically examine whether providing longer weight-loss treatment without altering content or intensity (12 months commercial referral vs. 12 weeks) leads to greater weight loss at one year and is sustained at 2 years. It will also evaluate the relative cost-effectiveness of the three interventions. This study has direct implications for primary care practice in the UK and will provide important information to inform the decisions of practitioners and commissioners about service provision. TRIAL REGISTRATION: Current Controlled Trials ISRCTN82857232. Date registered: 15/10/2012.

A phenomenological study of the effects of clinical negligence litigation on midwives in England: the personal perspective.

OBJECTIVE: to explore how midwives' personal involvement in clinical negligence litigation affects their emotional and psychological well-being. DESIGN: descriptive phenomenological study using semi-structured interviews. SETTING: in-depth interviews were conducted in participants' homes or at their place of work and focused on participants' experience of litigation. Participants were recruited from various regions of England. PARTICIPANTS: 22 National Health Service (NHS) midwives who had been alleged negligent. FINDINGS: unfamiliarity with the legal process when writing statements, attending case conferences and being a witness in court provoked significant stress for midwives. This was exacerbated by the prolonged nature of maternity claims. Support ranged from good to inadequate. Participants who no longer worked for the defendant Trust felt unsupported. Stress could manifest as physical and mental ill-health. Some midwives internalised the allegations of negligence believing their whole career had become worthless. Previous knowledge of the legal process ameliorated the experience. Midwives also exhibited anger and resentment when litigation concluded and some took years to heal from the experience. KEY CONCLUSIONS: midwives come from a caring and relational paradigm. When interfacing with the adversarial and contentious paradigm of tort law, midwives can abreact and suffer emotional, physical and psychological harm. Support for midwives experiencing litigation must be improved. IMPLICATIONS FOR PRACTICE: Understanding the effects of personal involvement in litigation is important in order to improve the quality of support for this group of midwives. It will also aid development of targeted education for undergraduate, post-graduate and in-service midwives. In the longer term it may help policy makers when considering reform of clinical negligence litigation and NHS employers to structure support mechanisms for staff involved.

Place of birth or place of death: an evaluation of 1139 maternal deaths in Nigeria.

OBJECTIVE: to describe the incidence of maternal death by age, marital status, timing and place of death in Ibadan North and Ido Local Government Areas of Oyo State, Nigeria. DESIGN: a retrospective study using multistage sampling with stratification and clustering to select local government areas, political wards and households. We included one eligible subject by household in the sample. Data on maternal mortality were collected using the principles of the indirect sisterhood method. SETTING: Ibadan city of Oyo state, Nigeria. We included eight randomly selected political wards from Ibadan North LGA (urban) and Ido LGA (rural). PARTICIPANTS: 3028 participants were interviewed using the four questions of the indirect sisterhood method: How many sisters have you ever had who are ever married (or who survived until age 15)? How many are dead? How many are alive? How many died while they were pregnant, during childbirth, or within six weeks after childbirth (that is, died of maternal causes)? We also included other questions such as place and timing of death, age of women at death and number of pregnancies. FINDINGS: 1139 deaths were reported to be related to pregnancy, childbirth or the puerperium. Almost half were aged between aged 25-34 years. More deaths occurred to women who were pregnant for the first time (33.4%, n=380) than for any other number of pregnancies, with 49.9% (n=521) dying within 24 hours after childbirth or abortion and 30.9% (n=322) dying after 24 hours but within 72 hours after childbirth or abortion. Only 71.5% (n=809) were reported to have been admitted to health-care facilities before their death, the percentage being higher in the urban LGA (72.4%, n=720) than the rural LGA (65.4%, n=89). The percentage being admitted varied from one political ward to another (from 42.9% to 80.4%), the difference being statistically significant (χ(2)=17.55, df=7, p=0.014). The majority of the deaths occurred after childbirth (63.5%, n=723). Most deaths were said to have occurred in the hospital (38.6%) or private clinic (28.2%), with 16.0% dying at home and 6.5% on the way to hospital. KEY CONCLUSIONS: maternal mortality in Nigeria is still unacceptably high. IMPLICATIONS FOR PRACTICE: ensure adequate training, recruitment and deployment of midwives and others with midwifery skills. Ensure midwives and other skilled birth attendants are backed up with functioning and well equipped health-care facilities. Provide health education and information to the public with regard to reproductive health and ensure the development and dissemination of a policy regarding attendance at birth by only health workers who have midwifery skills.

Community Study of maternal mortality in South West Nigeria: how applicable is the sisterhood method.

A significant reduction in maternal mortality was witnessed globally in the year 2010, yet, no significant reduction in the maternal mortality ratio (MMR) in Nigeria was recorded. The absence of accurate data on the numbers, causes and local factors influencing adverse maternal outcomes has been identified as a major obstacle hindering appropriate distribution of resources targeted towards improving maternal healthcare. This paper reports the first community based study that measures the incidence of maternal mortality in Ibadan, Nigeria using the indirect sisterhood method and explores the applicability of this method in a community where maternal mortality is not a rare event. A community-based study was conducted in Ibadan using the principles of the sisterhood method developed by Graham et al. for developing countries. Using a multi-stage sampling design with stratification and clustering, 3,028 households were selected. All persons approached agreed to take part in the study (a participation rate of 100%), with 2,877 respondents eligible for analysis. There was a high incidence of maternal mortality in the study setting: 1,324/6,519 (20.3%) sisters of the respondents had died, with 1,139 deaths reportedly related to pregnancy, childbirth or the puerperium. The MMR was 7,778 per 100,000 live births (95% CI 7,326-8,229). Adjusted for a published Total Fertility Rate of 6.0, the MMR was 6,525 per 100,000 live births (95% CI 6,144-6,909). Women in Ibadan were dying more from pregnancy related complications than from other causes. Findings of this study have implications for midwifery education, training and practice and for the first time provide policy makers and planners with information on maternal mortality in the community of Ibadan city and shed light on the causes of maternal mortality in the area.

Student midwives' views on maternity care just before their graduation.

AIM: To report a hermeneutic study of student midwives' views on maternity care just before their graduation. background: Woman-centred care, which is the hallmark of midwifery, is taught to midwifery students around the globe. Woman-centred care is advantageous for women at low obstetric risk. However, adopting this ideology might be a problem for student midwives whose clinical placements are mainly in a medicalized obstetric-led hospital setting. DESIGN: A hermeneutic phenomenological study was conducted. METHODS: In 2010, three focus groups were held where 19 student midwives participated. Data were transcribed verbatim and analysed using van Manen's approach. FINDINGS: The choice for midwifery was a 'positive' choice and not the result of an elimination process. Students' description of a midwife as a coach was in line with the international definition of a midwife. With regard to maternity care, midwifery students identified two types of care, factory-style care and tailored care, both of which were ascribed to caregivers and hospital culture. Furthermore, student midwives made the distinction between hierarchy and teamwork, referring to the professional relations in maternity care. Hierarchy was driven by tradition, it implied that decisions were made top-down, and it resulted in impersonal relations. Midwifery students felt it was unjust that midwives were not allowed to perform deliveries while having the legal autonomy to do so. CONCLUSION: In spite of the medicalized context, midwifery education succeeded in educating midwives who hold a woman-centred ideology. Midwifery students linked style of care to a person rather than to a profession.

A hermeneutic phenomenological study of Belgian midwives' views on ideal and actual maternity care.

OBJECTIVE: to explore midwives' views on ideal and actual maternity care. DESIGN: a qualitative hermeneutic phenomenological study based on the method of van Manen (1997) using individual in-depth interviews to gather data. SETTING: Flanders, Belgium. PARTICIPANTS: 12 purposively sampled midwives, of whom nine from three different non-university hospitals and three independent midwives conducting home births. FINDINGS: five major themes were identified: 'woman-centred care', 'cultural change', 'support', 'midwife and obstetrician as equal partners' and 'inter-collegial harmony'. In this paper 'woman-centred care', 'cultural change' and 'support' are discussed along with their subthemes. Midwives thought ideal maternity care should be woman-centred in which there were no unnecessary interventions, women were able to make an informed choice and there was continuity of care. Furthermore, ideal maternity care should be supported by midwifery education and an adequate staffing level. Also, a cultural change was wanted as actual maternity care was perceived to be highly medicalised. Barriers to achieving woman-centred care and possible strategies to overcome these were described. CONCLUSIONS: findings from this study were consistent with those of other studies on midwives' experience with obstetric-led care. Despite the medicalised care, midwives still held a woman-centred ideology. In order to be able to work according to their ideology, different barriers need to be addressed. Although midwives suggested strategies to overcome these barriers, some were considered to be very difficult to overcome.