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).

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.

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).

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.

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.

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.

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.

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.

Understanding the stigma of hyperemesis gravidarum: qualitative findings from an action research study.

BACKGROUND: Severe nausea and vomiting in pregnancy (hyperemesis gravidarum) can be a distressing and debilitating condition when it is uncontrolled. For all concerned, hyperemesis gravidarum can be difficult to treat satisfactorily, and women tend to be admitted to a hospital several times during early pregnancy. Our research objectives were to describe the experience of hyperemesis gravidarum from the perspective of affected women and to explore with health care professionals the barriers and facilitators to caring for women with the condition. METHODS: A qualitative research design was used. A total of 18 women were interviewed, of whom 8 had two or more interviews. Seven focus groups were conducted with health care professionals. Thematic data analysis was undertaken. RESULTS: The main themes emerging from the women's data were the effect and burden of the symptoms of the condition and feeling unpopular with staff. From the practitioner data, the main themes were the validity (or invalidity) of hospitalization for women, skepticism of the severity of symptoms, the psychological and social dimensions of the condition, and inadequate primary care services. CONCLUSIONS: The main findings revealed that hyperemesis gravidarum is a debilitating condition and that the unhelpful attitudes of practitioners may affect whether women access timely and appropriate care. Many women appear to be unsupported by primary care services and are distressed when perceived either as "time wasters" or someone else's responsibility. We propose that a tailored assessment and care plan for each woman is needed to help them control their symptoms, which ideally should be delivered in the community.

Campylobacter excreted into the environment by animal sources: prevalence, concentration shed, and host association.

An intensive study of 443 isolates of Campylobacter jejuni and Campylobacter coli from 2031 fecal samples excreted by animal sources including cattle, sheep, and pigs, a range of wild and domesticated avian species and pets is described. The prevalence found in the majority of animal sources ranged from 22% to 28% with poultry being highest at 41% and cats and dogs lowest (<5%). The average count excreted for each animal source was found not to be significantly different ranging from approximately 10(2) to 10(5) cfu/g. Multilocus sequence typing (MLST) identified phylogenies that exhibited host specificity. A number of clonal complexes (CCs) and sequence types (STs) were characteristic of particular hosts (e.g., CC-179, ST-637, and ST-1341 found only in pigeons and gulls). Analysis of genetic distance demonstrated numerous significant differences in the distribution of MLST types (CC, ST, and allele) between animal sources. Host association was quantified using structure that correctly assigned the nine animal sources with accuracies of 28%, 24%, and 55% at the CC, ST, and allele levels, respectively. This is substantially higher than would be expected by random allocation (11%) but farmyard poultry had the lowest assignment accuracy (13%, 13%, and 21%) suggesting that isolates were shared with a wide range of other animals. This study demonstrates the link between MLST type and host and provides data that can be used in risk assessment and food attribution models. Further, it demonstrates the applicability of MLST to characterize Campylobacter strains from a broad range of environmental sources.

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 emotions of integrating breastfeeding knowledge into practice for English midwives: a qualitative study.

BACKGROUND: Breastfeeding prevalence in the United Kingdom is one of the lowest in Europe. The midwife provides feeding support for new mothers but research suggests that midwives' knowledge of breastfeeding is limited. OBJECTIVE: To discover the views of English midwives in relation to their breastfeeding support role. DESIGN: Qualitative design. SETTINGS: Two maternity hospitals in Northwest England. PARTICIPANTS: Thirty midwives who cared for normal, healthy babies. Midwives were selected for interview using theoretical sampling principles from a pool of midwives who volunteered. Volunteers were accessed using a poster exhibited in relevant clinical areas. METHODS: Data were collected using audiotaped, in-depth interviews and were analysed using constant comparison techniques. RESULTS: The study highlights that differing professional knowledge and beliefs about breastfeeding support created intense, mainly negative, emotions for these midwives. Irritation and despair was experienced with the greater emphasis placed on research, rather than practice knowledge in policy and recommendations for practice. Disappointment was experienced when mothers did not conform to midwives' expectations. Conflict with differing peer-based knowledge generated feelings of intimidation and annoyance for some midwives. Some midwives demonstrated that they can sustain clinical decisions whilst based in a hostile environment, but others conformed to the practice expectations of their peers. Happiness was experienced when midwives described positive relationships with mothers, rather than their professional colleagues. CONCLUSIONS: The utilisation of professional knowledge in breastfeeding practice was a highly complex issue, and generated significant negative emotional distress, for these midwives.

Pregnant women's views about choice of intrapartum monitoring of the fetal heart rate: a questionnaire survey.

AIM: To investigate the degree of choice pregnant women at low obstetric risk had in making informed decisions on the use of intrapartum fetal monitoring techniques. METHODS: An exploratory descriptive design was used as part of a larger, multi-method study. A total of 63 pregnant women at low obstetric risk were approached to complete antepartum and postpartum questionnaires. Sixty-three women completed antepartum questionnaires, 38 of these 63 women also completed postpartum questionnaires. The data were analyzed using descriptive statistics. RESULTS: More than half of the sample wanted electronic fetal monitoring (EFM) in labor despite being classified at low risk for obstetric complications. Having choices and being in control was important to all respondents whilst in labor. Despite this, almost all respondents stated that midwives had not given them a choice of monitoring method. More than a half of the sample received some form of EFM. CONCLUSIONS: Intrapartum fetal monitoring practices for women with normal pregnancies do not reflect current evidence. Women still expect EFM in labor. Choice and control are very complex issues and as such are difficult to measure.

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.

'Breaking the rules' in baby-feeding practice in the UK: deviance and good practice?

OBJECTIVE: to discover the views of midwives in relation to baby feeding. DESIGN AND METHOD: qualitative using grounded theory. Data collection used in-depth interviews with 30 midwives who volunteered to participate. Field notes of the interaction between the researcher and participant were also recorded as data. The constant comparison process was used to generate codes and subsequent conceptualisations from the data. SETTING: two maternity units in the North of England, UK. FINDINGS: the core category of this study is called 'surviving' baby feeding, and the findings reported here are a significant theme that emerged. These midwives described a management strategy termed 'breaking the rules' for supporting mothers with baby feeding. The concept 'breaking the rules' represented practices that were not congruent with evidence-based, baby-feeding policy and recommendations, or with some practices that were usual in the local working environment. These midwives were aware of their actions but described how they 'hid' their behaviour from mothers and from their peers. Some of the behaviour described showed that these midwives 'broke the rules' in relation to professional requirements and the facilitation of informed decision making about feeding practices with the women in their care. However, some midwives reported examples of practice that is woman-centred, and supportive of baby feeding, but this was not acceptable to others in the working environment. KEY CONCLUSIONS AND IMPLICATIONS FOR PRACTICE: deviant behaviour was described by these midwives in relation to informed decision making and options for mothers in baby-feeding practice. These midwives 'knowingly concealed' their deviant practices from others. These behaviours should be taken seriously as they risk being negligent in relation to UK statutory professional requirements. However, practices that depart from those that are normal in the local working environment are not always negative and detrimental to the recipients of care; they can be positive. There needs to be more research, open discussion and debate about midwifery practice that does not always 'fit in' with professional, and 'normal' expectations. In this study, the term 'baby feeding' relates to how babies' nutritional needs are met.

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.