Health Care Professionals' and Parents' Perspectives on the Use of AI for Pain Monitoring in the Neonatal Intensive Care Unit: Multisite Qualitative Study.

BACKGROUND: The use of artificial intelligence (AI) for pain assessment has the potential to address historical challenges in infant pain assessment. There is a dearth of information on the perceived benefits and barriers to the implementation of AI for neonatal pain monitoring in the neonatal intensive care unit (NICU) from the perspective of health care professionals (HCPs) and parents. This qualitative analysis provides novel data obtained from 2 large tertiary care hospitals in Canada and the United Kingdom. OBJECTIVE: The aim of the study is to explore the perspectives of HCPs and parents regarding the use of AI for pain assessment in the NICU. METHODS: In total, 20 HCPs and 20 parents of preterm infants were recruited and consented to participate from February 2020 to October 2022 in interviews asking about AI use for pain assessment in the NICU, potential benefits of the technology, and potential barriers to use. RESULTS: The 40 participants included 20 HCPs (17 women and 3 men) with an average of 19.4 (SD 10.69) years of experience in the NICU and 20 parents (mean age 34.4, SD 5.42 years) of preterm infants who were on average 43 (SD 30.34) days old. Six themes from the perspective of HCPs were identified: regular use of technology in the NICU, concerns with regard to AI integration, the potential to improve patient care, requirements for implementation, AI as a tool for pain assessment, and ethical considerations. Seven parent themes included the potential for improved care, increased parental distress, support for parents regarding AI, the impact on parent engagement, the importance of human care, requirements for integration, and the desire for choice in its use. A consistent theme was the importance of AI as a tool to inform clinical decision-making and not replace it. CONCLUSIONS: HCPs and parents expressed generally positive sentiments about the potential use of AI for pain assessment in the NICU, with HCPs highlighting important ethical considerations. This study identifies critical methodological and ethical perspectives from key stakeholders that should be noted by any team considering the creation and implementation of AI for pain monitoring in the NICU.

LAparoscopic Versus Abdominal hysterectomy (LAVA): protocol of a randomised controlled trial.

INTRODUCTION: There is uncertainty about the advantages and disadvantages of laparoscopic hysterectomy compared with abdominal hysterectomy, particularly the relative rate of complications of the two procedures. While uptake of laparoscopic hysterectomy has been slow, the situation is changing with greater familiarity, better training, better equipment and increased proficiency in the technique. Thus, a large, robust, multicentre randomised controlled trial (RCT) is needed to compare contemporary laparoscopic hysterectomy with abdominal hysterectomy to determine the safest and most cost-effective technique. METHODS AND ANALYSIS: A parallel, open, non-inferiority, multicentre, randomised controlled, expertise-based surgery trial with integrated health economic evaluation and an internal pilot with an embedded qualitative process evaluation. A within trial-based economic evaluation will explore the cost-effectiveness of laparoscopic hysterectomy compared with open abdominal hysterectomy. We will aim to recruit 3250 women requiring a hysterectomy for a benign gynaecological condition and who were suitable for either laparoscopic or open techniques. The primary outcome is major complications up to six completed weeks postsurgery and the key secondary outcome is time from surgery to resumption of usual activities using the personalised Patient-Reported Outcomes Measurement Information System Physical Function questionnaire. The principal outcome for the economic evaluation is to be cost per QALY at 12 months' postsurgery. A secondary analysis is to be undertaken to generate costs per major surgical complication avoided and costs per return to normal activities. ETHICS AND DISSEMINATION: The study was approved by the West Midlands-Edgbaston Research Ethics Committee, 18 February 2021 (Ethics ref: 21/WM/0019). REC approval for the protocol version 2.0 dated 2 February 2021 was issued on 18 February 2021.We will present the findings in national and international conferences. We will also aim to publish the findings in high impact peer-reviewed journals. We will disseminate the completed paper to the Department of Health, the Scientific Advisory Committees of the RCOG, the Royal College of Nurses (RCN) and the BSGE. TRIAL REGISTRATION NUMBER: ISRCTN14566195.

Views of female genital mutilation survivors, men and health-care professionals on timing of deinfibulation surgery and NHS service provision: qualitative FGM Sister Study.

Background: Female genital mutilation is an important UK health-care challenge. There are no health benefits of female genital mutilation, and it is associated with lifelong physical, psychological and sexual impacts. The annual cost to the NHS to care for survivors is £100M. Deinfibulation may improve the health and well-being of some women, but there is no consensus on the optimal timing of surgery for type 3 survivors. UK care provision is reportedly suboptimal. Objectives: We aimed to explore the views of survivors, men and health-care professionals on the timing of deinfibulation surgery and NHS service provision. Methods: This was a qualitative study informed by the Sound of Silence framework. This framework is useful for researching sensitive issues and the health-care needs of marginalised populations. A total of 101 interviews with 44 survivors, 13 men and 44 health-care professionals were conducted, supplemented by two workshops with affected communities (participants, n = 10) and one workshop with stakeholders (participants, n = 30). Data were analysed using a hybrid framework method. Results: There was no clear consensus between groups on the optimal timing of deinfibulation. However, within groups, survivors expressed a preference for deinfibulation pre pregnancy; health-care professionals preferred antenatal deinfibulation, with the caveat that it should be the survivor's choice. There was no consensus among men. There was agreement that deinfibulation should take place in a hospital setting and be undertaken by a suitable health-care professional. Decision-making around deinfibulation was complex. Deficiencies in professionals' awareness, knowledge and understanding resulted in impacts on the provision of appropriate care. Although there were examples of good practice and positive care interactions, in general, service provision was opaque and remains suboptimal, with deficiencies most notable in mental health. Deinfibulation reportedly helps to mitigate some of the impacts of female genital mutilation. Interactions between survivors and health-care professionals were disproportionately framed around the law. The way in which services are planned and provided often silences the perspectives and preferences of survivors and their families. Limitations: Only a minority of the interviews were conducted in a language other than English, and the recruitment of survivors was predominantly through maternity settings, which meant that some voices may not have been heard. The sample of men was relatively small, limiting interpretation. Conclusions: In general, service provision remains suboptimal and can silence the perspectives and preferences of survivors. Deinfibulation services need to be widely advertised and information should highlight that the procedure will be carried out in hospital by suitable health-care professionals and that a range of time points will be offered to facilitate choice. Future services should be developed with survivors to ensure that they are clinically and culturally appropriate. Guidelines should be updated to better reflect the needs of survivors and to ensure consistency in service provision. Future work: Research is needed to (1) map female genital mutilation service provision; (2) develop and test effective education to address deficits in awareness and knowledge for affected communities and health-care professionals; and (3) develop, monitor and evaluate clinically and culturally competent female genital mutilation services. Trial registration: Current Controlled Trials ISRCTN14710507. Funding: This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment Programme and will be published in full in Health Technology Assessment; Vol. 27, No. 3. See the NIHR Journals Library website for further project information.

Female genital mutilation (or cutting) involves changing or removing parts of a girl's or woman's genitalia when there is no medical reason to do so. Many women and girls who have been cut live in the UK, where female genital mutilation is illegal. Some girls and women who have been cut experience problems in getting pregnant and having their baby. There are four types of cutting. Type 3 involves cutting and sewing together the genitalia, leaving only a small hole. Women and girls with type 3 mutilation can have a small operation to open their vagina. We do not know when the best time is to have this operation. We would also like to know more about how NHS female genital mutilation services can best help women. To answer these questions, we talked to 141 people, who were women who have been cut, men and health-care professionals. They told us that there is no ideal time to have the operation. Women who have been cut would like the operation before they get pregnant, but health-care professionals would like women to have it during their pregnancy. Men were not sure when it should happen. They all agreed that the operation should take place in a hospital and be carried out by a skilled professional. The way that we support women and men could be better and we need to improve the help that is offered. Sometimes women and men did not know where to go for help or how to ask for help. Women, men and health-care professionals sometimes found it hard to talk about cutting. Some health professionals did not have the right skills to undertake the operation. They told us that they need more training and clearer guidance to ensure that women feel cared for and safe.

Mifepristone and misoprostol versus placebo and misoprostol for resolution of miscarriage in women diagnosed with missed miscarriage: the MifeMiso RCT.

TRIAL DESIGN: A randomised, parallel-group, double-blind, placebo-controlled multicentre study with health economic and nested qualitative studies to determine if mifepristone (Mifegyne®, Exelgyn, Paris, France) plus misoprostol is superior to misoprostol alone for the resolution of missed miscarriage. METHODS: Women diagnosed with missed miscarriage in the first 14 weeks of pregnancy were randomly assigned (1 : 1 ratio) to receive 200 mg of oral mifepristone or matched placebo, followed by 800 µg of misoprostol 2 days later. A web-based randomisation system allocated the women to the two groups, with minimisation for age, body mass index, parity, gestational age, amount of bleeding and randomising centre. The primary outcome was failure to pass the gestational sac within 7 days after randomisation. The prespecified key secondary outcome was requirement for surgery to resolve the miscarriage. A within-trial cost-effectiveness study and a nested qualitative study were also conducted. Women who completed the trial protocol were purposively approached to take part in an interview to explore their satisfaction with and the acceptability of medical management of missed miscarriage. RESULTS: A total of 711 women, from 28 hospitals in the UK, were randomised to receive either mifepristone plus misoprostol (357 women) or placebo plus misoprostol (354 women). The follow-up rate for the primary outcome was 98% (696 out of 711 women). The risk of failure to pass the gestational sac within 7 days was 17% (59 out of 348 women) in the mifepristone plus misoprostol group, compared with 24% (82 out of 348 women) in the placebo plus misoprostol group (risk ratio 0.73, 95% confidence interval 0.54 to 0.98; p = 0.04). Surgical intervention to resolve the miscarriage was needed in 17% (62 out of 355 women) in the mifepristone plus misoprostol group, compared with 25% (87 out of 353 women) in the placebo plus misoprostol group (risk ratio 0.70, 95% confidence interval 0.52 to 0.94; p = 0.02). There was no evidence of a difference in the incidence of adverse events between the two groups. A total of 42 women, 19 in the mifepristone plus misoprostol group and 23 in the placebo plus misoprostol group, took part in an interview. Women appeared to have a preference for active management of their miscarriage. Overall, when women experienced care that supported their psychological well-being throughout the care pathway, and information was delivered in a skilled and sensitive manner such that women felt informed and in control, they were more likely to express satisfaction with medical management. The use of mifepristone and misoprostol showed an absolute effect difference of 6.6% (95% confidence interval 0.7% to 12.5%). The average cost per woman was lower in the mifepristone plus misoprostol group, with a cost saving of £182 (95% confidence interval £26 to £338). Therefore, the use of mifepristone and misoprostol for the medical management of a missed miscarriage dominated the use of misoprostol alone. LIMITATIONS: The results from this trial are not generalisable to women diagnosed with incomplete miscarriage and the study does not allow for a comparison with expectant or surgical management of miscarriage. FUTURE WORK: Future work should use existing data to assess and rank the relative clinical effectiveness and safety profiles for all methods of management of miscarriage. CONCLUSIONS: Our trial showed that pre-treatment with mifepristone followed by misoprostol resulted in a higher rate of resolution of missed miscarriage than misoprostol treatment alone. Women were largely satisfied with medical management of missed miscarriage and would choose it again. The mifepristone and misoprostol intervention was shown to be cost-effective in comparison to misoprostol alone. TRIAL REGISTRATION: Current Controlled Trials ISRCTN17405024. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 68. See the NIHR Journals Library website for further project information.

Miscarriage is a common complication of pregnancy, affecting approximately one in four women. Sometimes, medical treatment (i.e. tablets) may be offered to start or speed up the miscarriage process in order for the womb to empty itself. A drug called misoprostol (a tablet that makes the womb contract) is currently recommended for this treatment. However, the addition of another drug called mifepristone [a tablet that reduces pregnancy hormones (Mifegyne^®, Exelgyn, Paris, France)] might help the miscarriage to resolve more quickly. Therefore, we carried out the MifeMiso trial to test if mifepristone plus misoprostol is more effective than misoprostol alone in resolving miscarriage within 7 days. Women were randomly allocated by a computer to receive either mifepristone or placebo, followed by misoprostol 2 days later. Neither the women nor their health-care professionals knew which treatment they received. Some women also talked to the researchers about their experiences of taking part in the study. In total, 711 women were randomised to receive either mifepristone plus misoprostol or placebo plus misoprostol. Overall, 83% of women who received mifepristone plus misoprostol had miscarriage resolution within 7 days, compared with 76% of the women who received a placebo plus misoprostol. Surgery was required less often in women who received mifepristone plus misoprostol: 17% of women who received it required surgery, compared with 25% of women who received the placebo. Treatment with mifepristone did not appear to have any negative effects. Treatment with mifepristone plus misoprostol was more cost-effective than misoprostol alone, with an average saving of £182 per woman. Having taken part in the study, most women would choose medical management again and would recommend it to someone they knew who was experiencing a miscarriage.

Sepsis and Cognitive Assessment.

Sepsis disproportionally affects people over the age of 65, and with an exponentially increasing older population, sepsis poses additional risks for cognitive decline. This review summarizes published literature for (1) authorship qualification; (2) the type of cognitive domains most often assessed; (3) timelines for cognitive assessment; (4) the control group and analysis approach, and (5) sociodemographic reporting. Using key terms, a PubMed database review from January 2000 to January 2021 identified 3050 articles, and 234 qualified as full text reviews with 18 ultimately retained as summaries. More than half (61%) included an author with an expert in cognitive assessment. Seven (39%) relied on cognitive screening tools for assessment with the remaining using a combination of standard neuropsychological measures. Cognitive domains typically assessed were declarative memory, attention and working memory, processing speed, and executive function. Analytically, 35% reported on education, and 17% included baseline (pre-sepsis) data. Eight (44%) included a non-sepsis peer group. No study considered sex or race/diversity in the statistical model, and only five studies reported on race/ethnicity, with Caucasians making up the majority (74%). Of the articles with neuropsychological measures, researchers report acute with cognitive improvement over time for sepsis survivors. The findings suggest avenues for future study designs.

C-STICH2: emergency cervical cerclage to prevent miscarriage and preterm birth-study protocol for a randomised controlled trial.

BACKGROUND: Cervical cerclage is a recognised treatment to prevent late miscarriage and pre-term birth (PTB). Emergency cervical cerclage (ECC) for cervical dilatation with exposed unruptured membranes is less common and the potential benefits of cerclage are less certain. A randomised control trial is needed to accurately assess the effectiveness of ECC in preventing pregnancy loss compared to an expectant approach. METHODS: C-STICH2 is a multicentre randomised controlled trial in which women presenting with cervical dilatation and unruptured exposed membranes at 16 + 0 to 27 + 6 weeks gestation are randomised to ECC or expectant management. Trial design includes 18 month internal pilot with embedded qualitative process evaluation, minimal data set and a within-trial health economic analysis. Inclusion criteria are ≥16 years, singleton pregnancy, exposed membranes at the external os, gestation 16 + 0-27 + 6 weeks, and informed consent. Exclusion criteria are contraindication to cerclage, cerclage in situ or previous cerclage in this pregnancy. Randomisation occurs via an online service in a 1:1 ratio, using a minimisation algorithm to reduce chance imbalances in key prognostic variables (site, gestation and dilatation). Primary outcome is pregnancy loss; a composite including miscarriage, termination of pregnancy and perinatal mortality defined as stillbirth and neonatal death in the first week of life. Secondary outcomes include all core outcomes for PTB. Two-year development outcomes will be assessed using general health and Parent Report of Children's Abilities-Revised (PARCA-R) questionnaires. Intended sample size is 260 participants (130 each arm) based on 60% rate of pregnancy loss in the expectant management arm and 40% in the ECC arm, with 90% power and alpha 0.05. Analysis will be by intention-to-treat. DISCUSSION: To date there has been one small trial of ECC in 23 participants which included twin and singleton pregnancies. This small trial along with the largest observational study (n = 161) found ECC to prolong pregnancy duration and reduce deliveries before 34 weeks gestation. It is important to generate high quality evidence on the effectiveness of ECC in preventing pregnancy loss, and improve understanding of the prevalence of the condition and frequency of complications associated with ECC. An adequately powered RCT will provide the highest quality evidence regarding optimum care for these women and their babies. TRIAL REGISTRATION: ISRCTN Registry ISRCTN12981869 . Registered on 13th June 2018.

Mifepristone and misoprostol versus misoprostol alone for the management of missed miscarriage (MifeMiso): a randomised, double-blind, placebo-controlled trial.

BACKGROUND: The anti-progesterone drug mifepristone and the prostaglandin misoprostol can be used to treat missed miscarriage. However, it is unclear whether a combination of mifepristone and misoprostol is more effective than administering misoprostol alone. We investigated whether treatment with mifepristone plus misoprostol would result in a higher rate of completion of missed miscarriage compared with misoprostol alone. METHODS: MifeMiso was a multicentre, double-blind, placebo-controlled, randomised trial in 28 UK hospitals. Women were eligible for enrolment if they were aged 16 years and older, diagnosed with a missed miscarriage by pelvic ultrasound scan in the first 14 weeks of pregnancy, chose to have medical management of miscarriage, and were willing and able to give informed consent. Participants were randomly assigned (1:1) to a single dose of oral mifepristone 200 mg or an oral placebo tablet, both followed by a single dose of vaginal, oral, or sublingual misoprostol 800 µg 2 days later. Randomisation was managed via a secure web-based randomisation program, with minimisation to balance study group assignments according to maternal age (<30 years vs ≥30 years), body-mass index (<35 kg/m2vs ≥35 kg/m2), previous parity (nulliparous women vs parous women), gestational age (<70 days vs ≥70 days), amount of bleeding (Pictorial Blood Assessment Chart score; ≤2 vs ≥3), and randomising centre. Participants, clinicians, pharmacists, trial nurses, and midwives were masked to study group assignment throughout the trial. The primary outcome was failure to spontaneously pass the gestational sac within 7 days after random assignment. Primary analyses were done according to intention-to-treat principles. The trial is registered with the ISRCTN registry, ISRCTN17405024. FINDINGS: Between Oct 3, 2017, and July 22, 2019, 2595 women were identified as being eligible for the MifeMiso trial. 711 women were randomly assigned to receive either mifepristone and misoprostol (357 women) or placebo and misoprostol (354 women). 696 (98%) of 711 women had available data for the primary outcome. 59 (17%) of 348 women in the mifepristone plus misoprostol group did not pass the gestational sac spontaneously within 7 days versus 82 (24%) of 348 women in the placebo plus misoprostol group (risk ratio [RR] 0·73, 95% CI 0·54-0·99; p=0·043). 62 (17%) of 355 women in the mifepristone plus misoprostol group required surgical intervention to complete the miscarriage versus 87 (25%) of 353 women in the placebo plus misoprostol group (0·71, 0·53-0·95; p=0·021). We found no difference in incidence of adverse events between the study groups. INTERPRETATION: Treatment with mifepristone plus misoprostol was more effective than misoprostol alone in the management of missed miscarriage. Women with missed miscarriage should be offered mifepristone pretreatment before misoprostol to increase the chance of successful miscarriage management, while reducing the need for miscarriage surgery. FUNDING: UK National Institute for Health Research Health Technology Assessment Programme.

Burden of Mental, Neurological, Substance Use Disorders and Self-Harm in North America: A Comparative Epidemiology of Canada, Mexico, and the United States.

OBJECTIVE: To estimate the burden of mental, neurological, substance use disorders and self-harm (MNSS) in Canada, Mexico, and the United States. METHOD: We extracted 2017 data from the Global Burden of Disease online database. Based on a previously developed framework to classify and aggregate the burden of specific disorders and symptoms, we reestimated the MNSS burden to include suicide, alcohol use, drug use, specific neurological, and painful somatic symptom disorders. We analyzed age-sex-specific patterns within and between countries. RESULTS: The MNSS burden is the largest of all disorder groupings. It is lowest in Mexico, intermediate in Canada, and highest in the United States. Exceptions are alcohol use, bipolar, conduct disorders, and epilepsy, which are highest in Mexico; and painful somatic syndromes and headaches, which are highest in Canada. The burden of drug use disorders in the United States is twice the burden in Canada, and 7 times the burden in Mexico. MNSS become the most burdensome of all disorder groups by age 10, staying at the top until age 60, and show a distinct pattern across the lifetime. The top three MNSS disorders for men are a combination of substance use disorders and self-harm (United States), with the addition of painful somatic syndromes (Canada), and headaches (Mexico). For women, the top three are headaches and depression (all countries), drug use (United States), neurocognitive disorders (Mexico), and painful somatic syndromes (Canada). CONCLUSION: MNSS are the most burdensome disease grouping and should be prioritized for funding in Canada, Mexico, and the United States.

Pressure garment to prevent abnormal scarring after burn injury in adults and children: the PEGASUS feasibility RCT and mixed-methods study.

BACKGROUND: Eleven million people suffer a fire-related injury worldwide every year, and 71% have significant scarring. Pressure garment therapy (PGT) is a standard part of burn scar management, but there is little evidence of its clinical effectiveness or cost-effectiveness. OBJECTIVE: To identify the barriers to, and the facilitators of, conducting a randomised controlled trial (RCT) of burn scar management with and without PGT and test whether or not such a trial is feasible. DESIGN: Web-based surveys, semistructured individual interviews, a pilot RCT including a health economic evaluation and embedded process evaluation. SETTING: UK NHS burns services. Interviews and the pilot trial were run in seven burns services. PARTICIPANTS: Thirty NHS burns services and 245 staff provided survey responses and 15 staff participated in individual interviews. Face-to-face interviews were held with 24 adult patients and 16 parents of paediatric patients who had undergone PGT. The pilot trial recruited 88 participants (57 adults and 31 children) who were at risk of hypertrophic scarring and were considered suitable for scar management therapy. Interviews were held with 34 participants soon after recruitment, with 23 participants at 12 months and with eight staff from six sites at the end of the trial. INTERVENTIONS: The intervention was standard care with pressure garments. The control was standard care comprising scar management techniques involving demonstration and recommendations to undertake massage three or four times per day with moisturiser, silicone treatment, stretching and other exercises. MAIN OUTCOME MEASURES: Feasibility was assessed by eligibility rates, consent rates, retention in allocated arms, adherence with treatment and follow-up and completion of outcome assessments. The outcomes from interview-based studies were core outcome domains and barriers to, and facilitators of, trial participation and delivery. RESULTS: NHS burns services treat 2845 patients per annum (1476 paediatric and 1369 adult) and use pressure garments for 6-18 months, costing £2,171,184. The majority of staff perceived a need for a RCT of PGT, but often lacked equipoise around the research question and PGT as a treatment. Strong views about the use of PGT have the potential to influence the conduct of a full-scale RCT. A range of outcome domains was identified as important via the qualitative research: perceptions of appearance, specific scar characteristics, function, pain and itch, broader psychosocial outcomes and treatment burden. The outcome tools evaluated in the pilot trial did not cover all of these domains. The planned 88 participants were recruited: the eligibility rate was 88% [95% confidence interval (CI) 83% to 92%], the consent rate was 47% (95% CI 40% to 55%). Five (6%) participants withdrew, 14 (16%) were lost to follow-up and 8 (9%) crossed over. Adherence was as in clinical practice. Completion of outcomes was high for adult patients but poorer from parents of paediatric patients, particularly for quality of life. Sections on range of movement and willingness to pay were found to be challenging and poorly completed. LIMITATIONS: The Brisbane Burn Scar Impact Profile appears more suitable in terms of conceptual coverage than the outcome scales that were used in the trial but was not available at the time of the study. CONCLUSIONS: A definitive RCT of PGT in burn scar management appears feasible. However, staff attitudes to the use of pressure garments may lead to biases, and the provision of training and support to sites and an ongoing assessment of trial processes are required. FUTURE WORK: We recommend that any future trial include an in-depth mixed-methods recruitment investigation and a process evaluation to account for this. TRIAL REGISTRATION: Current Controlled Trials ISRCTN34483199. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 22, No. 36. See the NIHR Journals Library website for further project information.

[The burden of mental disorders, neurological, substance use and suicide: Report on mental health priorities in Argentina]. / Carga de los trastornos mentales, neurológicos, por consumo de sustancias y suicidio y prioridades de salud mental en Argentina.

The objective of this study is to provide an estimate of the burden of disease related to mental health in Argentina, in order to provide elements for the rational prioritization of resource allocation and the development of services. Based on the estimations made by the Study of the Global Burden of Disease (1) we add an analysis of the load product of: a) self-injuries and suicide; b) common neurological disorders with severe psychological and behavioral manifestations; c) somatic consequences of alcohol use disorder; and iv) an estimate of the disorder by somatic symptoms with prominent pain. The burden of disease caused by mental, neurological, substance use and suicide disorders (MNSS) is approximately one fifth of the years of life adjusted for disability (DALYs) and more than a third of the years lived with disability (ADLs) total, resulting in the most disabling subgroup of all non-communicable diseases (NCDs), and far exceeding the combined group of infectious and maternal-child diseases, and the group of non-self-inflicted accidents and injuries. The analysis of DALYs by age and sex allows a hierarchy of the disorders that should guide the development of services for MNSS disorders, their integration in primary care, and the allocation of resources. The first level of care is the only one with a relatively homogeneous presence throughout the country, being the only one capable of effectively increasing coverage and reducing inequality. The strengthening of the first level of care can be achieved through training in mental health of non-specialized personnel and the use of computer and communication technology resources to counteract regional inequities in coverage. Such strategic vision will allow to diminish: the excessive expenses in specialized resources, which by definition are more expensive and intervene only when the pathology exceeded a certain threshold; and the indirect costs caused by the loss of labor productivity. Fundamentally, it will allow increasing coverage and reversing regional and socioeconomic inequality in the quality of mental health care in a country rich in professional resources.

Outcomes important to burns patients during scar management and how they compare to the concepts captured in burn-specific patient reported outcome measures.

BACKGROUND: Pressure garment therapy (PGT) is an established treatment for the prevention and treatment of hypertrophic scarring; however, there is limited evidence for its effectiveness. Burn survivors often experience multiple issues many of which are not adequately captured in current PGT trial measures. To assess the effectiveness of PGT it is important to understand what outcomes matter to patients and to consider whether patient-reported outcome measures (PROMs) can be used to ascertain the effect of treatments on patients' health-related quality of life. This study aimed to (a) understand the priorities and perspectives of adult burns patients and the parents of burns patients who have experienced PGT via in-depth qualitative data, and (b) compare these with the concepts captured within burn-specific PROMs. METHODS: We undertook 40 semi-structured interviews with adults and parents of paediatric and adolescent burns patients who had experienced PGT to explore their priorities and perspectives on scar management. Interviews were audio-recorded, transcribed and thematically analysed. The outcomes interpreted within the interview data were then mapped against the concepts captured within burn-specific PROMs currently in the literature. RESULTS: Eight core outcome domains were identified as important to adult patients and parents: (1) scar characteristics and appearance, (2) movement and function, (3) scar sensation, (4) psychological distress, adjustments and a sense of normality, (5) body image and confidence, (6) engagement in activities, (7) impact on relationships, and (8) treatment burden. CONCLUSIONS: The outcome domains presented reflect a complex holistic patient experience of scar management and treatments such as PGT. Some currently available PROMs do capture the concepts described here, although none assess psychological adjustments and attainment of a sense of normality following burn injury. The routine use of PROMs that represent patient experience and their relative contribution to trial outcome assessment versus clinical measures is now a matter for further research and debate.

Antimicrobial use in food-producing animals: a rapid evidence assessment of stakeholder practices and beliefs.

Food-producing animals throughout the world are likely to be exposed to antimicrobial (AM) treatment. The crossover in AM use between human and veterinary medicine raises concerns that antimicrobial resistance (AMR) may spread from food-producing animals to humans, driving the need for further understanding of how AMs are used in livestock practice as well as stakeholder beliefs relating to their use. A rapid evidence assessment (REA) was used to collate research on AM use published in peer-reviewed journals between 2000 and 2016. Forty-eight papers were identified and reviewed. The summary of findings highlights a number of issues regarding current knowledge of the use of AMs in food-producing animals and explores the attitudes of interested parties regarding the reduction of AM use in livestock. Variation between and within countries, production types and individual farms demonstrates the complexity of the challenge involved in monitoring and regulating AM use in animal agriculture. Many factors that could influence the prevalence of AMR in livestock are of concern across all sections of the livestock industry. This REA highlights the potential role of farmers and veterinarians and of other advisors, public pressure and legislation to influence change in the use of AMs in livestock.

A qualitative study exploring how Somali women exposed to female genital mutilation experience and perceive antenatal and intrapartum care in England.

OBJECTIVES: To explore how Somali women exposed to female genital mutilation experience and perceive antenatal and intrapartum care in England. We explored women's perceptions of deinfibulation, caesarean section and vaginal delivery; their experiences of care during pregnancy and labour; and factors that affect ability to access these services, in order to make recommendations about future practice. DESIGN: A descriptive, exploratory qualitative study using face-to-face semistructured interviews. Interviews were audio-recorded, transcribed and data were analysed using a thematic approach. An interpreter was used when required (n=3). SETTING: Participants recruited from 2 community centres in Birmingham, England. PARTICIPANTS: Convenience and snowball sample of 10 Somali women resident in Birmingham, who had accessed antenatal care services in England within the past 5 years. RESULTS: 3 core themes were interpreted: (1) Experiences of female genital mutilation during life, pregnancy and labour: Female genital mutilation had a significant physical and psychological impact, influencing decisions to undergo deinfibulation or caesarean section. Women delayed deinfibulation until labour to avoid undergoing multiple operations if an episiotomy was anticipated. (2) Experience of care from midwives: Awareness of female genital mutilation from midwives led to open communication and stronger relationships with women, resulting in more positive experiences. (3) Adaptation to English life: Good language skills and social support networks enabled women to access these services, while unfavourable social factors (eg, inability to drive) impeded. CONCLUSIONS: Female genital mutilation impacts Somali women's experiences of antenatal and intrapartum care. This study suggests that midwives should routinely ask Somali women about female genital mutilation to encourage open communication and facilitate more positive experiences. As antenatal deinfibulation is unpopular, we should consider developing strategies to promote deinfibulation to non-pregnant women, to align with current guidelines. Women with unfavourable social factors may require additional support to improve access to English antenatal care services.

Health in All Policies in South Australia: what has supported early implementation?

Health in All Policies (HiAP) is a policy development approach that facilitates intersectoral responses to addressing the social determinants of health and health equity whilst, at the same time, contributing to policy priorities across the various sectors of government. Given that different models of HiAP have been implemented in at least 16 countries, there is increasing interest in how its effectiveness can be optimized. Much of the existing literature on HiAP remains descriptive, however, and lacks critical, empirically informed analyses of the elements that support implementation. Furthermore, literature on HiAP, and intersectoral action more generally, provides little detail on the practical workings of policy collaborations. This paper contributes empirical findings from a multi-method study of HiAP implementation in South Australia (SA) between 2007 and 2013. It considers the views of public servants and presents analysis of elements that have supported, and impeded, implementation of HiAP in SA. We found that HiAP has been implemented in SA using a combination of interrelated elements. The operation of these elements has provided a strong foundation, which suggests the potential for HiAP to extend beyond being an isolated strategy, to form a more integrated and systemic mechanism of policy-making. We conclude with learnings from the SA experience of HiAP implementation to inform the ongoing development and implementation of HiAP in SA and internationally.

Effectiveness of a mobile, drop-in stop smoking service in reaching and supporting disadvantaged UK smokers to quit.

BACKGROUND: In countries where there are large disparities in smoking with persistent high rates among disadvantaged groups, there is a need to ensure that stop smoking services (SSS) reach such smokers. The primary aim of this study was to evaluate the effectiveness of a mobile, drop-in, community-based SSS in reaching more disadvantaged smokers, particularly those from routine and manual (RM) occupation groups, than standard services; secondary aims were to evaluate effectiveness in reaching those who had not previously accessed SSS, triggering unplanned quit behaviour, helping people quit and cost-effectiveness. METHODS: Following a 4-week pilot period, a mobile drop-in SSS was delivered across various public locations in Nottingham City, UK for 6 months, offering behavioural and pharmacological support via one-to-one consultations with trained cessation advisors. Detailed demographic and smoking behaviour data were collected from all clients accessing the mobile SSS, and Nottingham's standard SSS for comparison. RESULTS: Compared with smokers accessing the standard SSS (n=1856), mobile SSS smokers (n=811) were significantly more likely to be from the RM group (33.3% vs 27.2%, p=0.002), and to be first-time SSS users (67.8% vs 59.3%, p<0.001). Nearly 1 in 10 smokers setting a quit date through the mobile SSS had no prior quit intentions. The cost per smoker setting a quit date for the mobile SSS was only slightly higher than the standard SSS (£224 vs £202). CONCLUSIONS: A mobile drop-in SSS is an effective way of reaching more disadvantaged smokers from RM occupations, as well as those who have not previously accessed standard SSS and those without prior quit intentions.

Smoking in the home after childbirth: prevalence and determinants in an English cohort.

OBJECTIVES: Children's exposure to secondhand smoke (SHS) is causally linked to childhood morbidity and mortality. Over 38% of English children (aged 4-15) whose parents are smokers are exposed to SHS in the home. Little is known about the prevalence of SHS exposure in the homes of young infants (≤3 months). This study aimed to estimate maternal self-reported prevalence of SHS exposure among infants of women who smoked just before or during pregnancy, and identify factors associated with exposure. SETTING: Primary Care, Nottingham, England. PARTICIPANTS: Current and recent ex-smoking pregnant women (n=850) were recruited in Nottingham, England. Women completed questionnaires at 8-26 weeks gestation and 3 months after childbirth. Data on smoking in the home 3 months after childbirth was available for 471 households. PRIMARY AND SECONDARY OUTCOME MEASURES: Maternal-reported smoking in the home 3 months after childbirth. RESULTS: The prevalence of smoking in the home 3 months after childbirth was 16.3% (95% CI 13.2% to 19.8%) and after multiple imputation controlling for non-response 18.2% (95% CI 14.0% to 22.5%). 59% of mothers were current smokers; of these, 24% reported that smoking occurred in their home compared to 4.7% of non-smokers. In multivariable logistic regression, mothers smoking ≥11 cigarettes per day were 8.2 times (95% CI 3.4 to 19.6) more likely to report smoking in the home. Younger age, being of non-white ethnicity, increased deprivation and less negative attitudes towards SHS were also associated with smoking in the home. CONCLUSIONS: This survey of smoking in the home 3 months after childbirth found a lower prevalence than has been reported in older children. Interventions to support smoking mothers to quit, or to help them restrict smoking in the home, should target attitudinal change and address inequality relating to social disadvantage, younger age and non-white ethnic groups.

Critical design features for establishing a childhood obesity monitoring program in Australia.

Efforts to combat childhood obesity in Australia are hampered by the lack of quality epidemiological data to routinely monitor the prevalence and distribution of the condition. This paper summarises the literature on issues relevant to childhood obesity monitoring and makes recommendations for implementing a school-based childhood obesity monitoring program in Australia. The primary purpose of such a program would be to collect population-level health data to inform both policy and the development and evaluation of community-based obesity prevention interventions. Recommendations are made for the types of data to be collected, data collection procedures and program management and evaluation. Data from an obesity monitoring program are crucial for directing and informing policies, practices and services, identifying subgroups at greatest risk of obesity and evaluating progress towards meeting obesity-related targets. Such data would also increase the community awareness necessary to foster change.

Predictors of children's secondhand smoke exposure at home: a systematic review and narrative synthesis of the evidence.

BACKGROUND: Children's exposure to secondhand smoke (SHS) has been causally linked to a number of childhood morbidities and mortalities. Over 50% of UK children whose parents are smokers are regularly exposed to SHS at home. No previous review has identified the factors associated with children's SHS exposure in the home. AIM: To identify by systematic review, the factors which are associated with children's SHS exposure in the home, determined by parent or child reports and/or biochemically validated measures including cotinine, carbon monoxide or home air particulate matter. METHODS: Electronic searches of MEDLINE, EMBASE, PsychINFO, CINAHL and Web of Knowledge to July 2014, and hand searches of reference lists from publications included in the review were conducted. FINDINGS: Forty one studies were included in the review. Parental smoking, low socioeconomic status and being less educated were all frequently and consistently found to be independently associated with children's SHS exposure in the home. Children whose parents held more negative attitudes towards SHS were less likely to be exposed. Associations were strongest for parental cigarette smoking status; compared to children of non-smokers, those whose mothers or both parents smoked were between two and 13 times more likely to be exposed to SHS. CONCLUSION: Multiple factors are associated with child SHS exposure in the home; the best way to reduce child SHS exposure in the home is for smoking parents to quit. If parents are unable or unwilling to stop smoking, they should instigate smoke-free homes. Interventions targeted towards the socially disadvantaged parents aiming to change attitudes to smoking in the presence of children and providing practical support to help parents smoke outside the home may be beneficial.

Use of tobacco retail permitting to reduce youth access and exposure to tobacco in Santa Clara County, California.

OBJECTIVE: To target youth smoking, the impact of a local tobacco retail permit was evaluated on the number and location of tobacco retailers, and on the level of enforcement and compliance with tobacco sales regulations from 2010 to 2012 within unincorporated Santa Clara County, California. METHODS: Geographic Information Systems (GIS) mapping of each of 36 tobacco retailers pre- and post-intervention, observational surveys of tobacco retail environments pre- and post-intervention, and post-intervention enforcement surveys to measure location of sales, level of enforcement action, and compliance with laws governing sale of tobacco products were conducted. RESULTS: Eleven (30.6%) of the initial 36 retailers selling tobacco at the start of the intervention stopped selling tobacco post intervention. Of these 11 retailers, one was within 500feet of another retailer, and three were within 1000feet of a K-12 school. Ten (91%) of the retailers who stopped selling tobacco were non-traditional retailers. CONCLUSION: An immediate reduction in the number of stores selling tobacco occurred following implementation of tobacco retail permitting. Post-implementation, all retailers who underwent compliance checks were in compliance with laws prohibiting sales of tobacco to minors. Compliance with laws governing the sale of tobacco has potential to reduce access and use of tobacco products by youth.