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Background Inappropriate marketing of human milk substitutes negatively influences efforts to protect breastfeeding. Although healthcare professionals can positively influence infant feeding decisions, government regulations permit manufacturers to communicate messages to them through advertising. Research Aims (1) To identify the extent of human milk substitute advertising in publications aimed at United Kingdom healthcare professionals and (2) to describe compliance with the International Code of Marketing of Breast-Milk Substitutes and United Kingdom Formula and Follow-on Formula Regulations. Methods This was a cross-sectional observational study. We reviewed publications targeting healthcare professionals working with families in the United Kingdom ( N = 19). Quantity and type of human milk substitute advertisements, as a proportion of all advertising, in each publication were recorded. All unique advertisements were double assessed for compliance. Results Human milk substitute advertising was found in nine (47%) of the 19 publications (four affiliated with professional associations), making up 10.3% ( n = 196) of these publications’ total advertising. Of human milk substitute advertisements found, 65.4% ( n = 110) were for products used to manage cows’ milk protein allergy. Of the 32 unique human milk substitute advertisements found, none complied with the International Code of Marketing of Breast Milk Substitutes or United Kingdom Formula and Follow-on Formula Regulations. Conclusions Many healthcare professionals’ publications had non-compliant human milk substitute advertisements. There is an urgent need to ensure full compliance with international and local regulation in future advertisements and to consider whether advertisements are justified at all.

Introduction: Solid papillary carcinoma (SPC) and encapsulated papillary carcinoma (EPC) of the breast are usually considered in situ lesions due to favorable prognosis, despite the variable presence of myoepithelial cells. We aimed to describe clinical-pathologic features including basement membrane (BM) studies in these tumors. Methods: Patients diagnosed with SPC and EPC in 2000–2019 were retrospectively identified. Microscopic slides and clinical history were reviewed. Immunohistochemical stains for BM and myoepithelial markers were performed. Results: Of 23 SPCs and 27 EPCs, there were 5/23 (21.7%) pure SPCs and 9/27 (33.3%) pure EPCs, while 4/23 (17.4%) and 12/27 (44.5%) were associated with ductal carcinoma in situ (DCIS), and 6/23 (26.1%) and 6/27 (22.2%) with invasive carcinoma, respectively; 8/23 (34.8%) SPCs were considered invasive. The median tumor size was 1.7 cm (range 0.1–16). All tumors were positive for hormone receptors and negative for HER2. Myoepithelial cells were absent in 20 tumors (40%) and focally present in 30 (60%). Collagen IV and laminin were negative in most invasive lesions, but they were expressed in 21/21 (100%) and 18/21 (85.7%) of EPCs without invasion, and 16/17 (94.1%) and 10/17 (58.8%) SPCs, including invasive SPCs, respectively. Lymph node involvement was identified in 3/26 (11.5%) patients, including micrometastasis in 1 EPC associated with DCIS, macrometastasis in 1 EPC associated with invasive carcinoma, and isolated tumor cells in 1 invasive SPC. Of 31 patients with outcome data (median follow-up 35 months, range 1–85), 2 (6.5%; 1 SPC, 1 EPC) developed local recurrence, both associated with invasive carcinoma. No distant recurrences or deaths were observed. Conclusions: Our study confirms favorable prognosis of SPCs and EPCs, with 2 local recurrences occurring in the presence of invasion. SPCs are more commonly associated with invasive carcinoma or considered invasive compared to EPCs (60.9 vs. 22.2%). The presence of BM material and lack of lymph node involvement in most cases indicates that the majority of these tumors may represent in situ lesions; however, some may behave as low-grade invasive malignancy with metastatic potential even in the absence of conventional invasion.

Lymphomas associated with breast implants are mostly of the T-cell type. They are predominantly anaplastic lymphoma kinase-negative anaplastic large cell lymphoma (ALK-negative ALCL) characterized by CD30 positivity universally. Whilst the majority of primary breast lymphomas occurring in the absence of breast implants are of B-cell origin, there are few cases of implant-associated B-cell lymphomas reported to date in the literature, a subset of which are diffuse large B-cell lymphoma (DLBCL). Given the rarity of this entity, we describe two cases of breast implant-associated DLBCL. Both patients developed Epstein-Barr Virus (EBV)-positive large cell lymphoma of B-cell origin confined to the implant capsule with no evidence of systemic lymphoma. Considering the association with EBV, the activated B-cell phenotype and the presumed chronic inflammatory environment associated with the implant capsule, these might represent forms of DLBCL associated with chronic inflammation (DLBCL-CI) or fibrin-associated DLBCL (FA-DLBCL). Treatment included implant removal with total capsulectomy, and for one of the cases adjuvant systemic chemotherapy. Recognizing this rare type of breast implant-associated B-cell lymphoma could improve our understanding of this entity and hence develop appropriate management strategies.

Background Social support has an important role in successful weight loss. The aim of this study was to assess the feasibility and acceptability of an app-, web- and social support-based intervention in supporting adults with obesity to achieve weight loss. Methods The intervention and evaluation methods were tested in a feasibility randomised controlled trial. Adults in the Greater Glasgow and Clyde Health Board area of Scotland with a body mass index ≥ 30 kg/m2 were recruited and randomised 2:1 (intervention to control). The feasibility and acceptability of the intervention and trial methods were assessed against pre-specified progression criteria, via process, economic and outcome evaluation. Three primary outcomes were explored: BMI, diet and physical activity, as well as a number of secondary outcomes. The intervention group had access to the HelpMeDoIt! intervention for 12 months. This encouraged them to (i) set goals, (ii) monitor progress and (iii) harness social support by inviting ‘helpers’ from their existing social network. The control group received a healthy lifestyle leaflet. Results One hundred and nine participants were recruited, with 84 participants (77%) followed-up at 12 months. The intervention and trial methods were feasible and acceptable. Participants and helpers were generally positive. Of the 54 (74%) participants who downloaded the app, 48 (89%) used it. Interview data indicated that HelpMeDoIt! promoted social support from existing social networks to support weight loss. This support was often given outside of the app. Outcomes were compared using linear regression models, with randomised group, the baseline measurement of the outcome, age and gender as predictor variables. These analyses were exploratory and underpowered to detect effects. However, all pre-specified primary outcome effects (BMI, diet and physical activity) had wide confidence intervals and were therefore consistent with clinically relevant benefits. Objective physical activity measures perhaps showed most potential (daily step count (p = 0.098; 1187 steps [− 180, 2555])) and sedentary time (p = 0.022; − 60.8 min [− 110.5, − 11.0]). However, these outcomes were poorly completed. Conclusions The study demonstrated that a novel social support intervention involving support from participants’ close social networks, delivered via app and website, has potential to promote weight loss and is feasible and acceptable. Trial registration ISRCTN, ISRCTN85615983. Registered 25 September 2014

Persistent delirium is associated with poor outcomes in older adults but little is known about how to support longer-term recovery from delirium. The aim of this review was to identify and synthesise literature to understand mechanisms of recovery from delirium as a basis for designing an intervention that enables more effective recovery.A systematic search of literature relevant to the research question was conducted in two phases. Phase one focused on studies evaluating the efficacy of interventions to support recovery from delirium, and stage two used a wider search strategy to identify other relevant literature including similar patient groups and wider methodologies. Synthesis of the literature followed realist principles.Phase one identified four relevant studies and stage two identified a further forty-six studies. Three interdependent recovery domains and four recovery facilitators were identified. Recovery domains were 1) support for physical recovery through structured exercise programmes; 2) support for cognitive recovery through reality orientation and cognitive stimulation; 3) support for emotional recovery through talking with skilled helpers. Recovery facilitators were 1) involvement and support of carers; 2) tailoring intervention to individual needs, preferences and abilities; 3) interpersonal connectivity and continuity in relationships and; 4) facilitating positive expressions of self.Multicomponent interventions with elements that address all recovery domains and facilitators may have the most promise. Future research should build on this review and explore patients', carers', and professionals' tacit theories about the persistence of delirium or recovery from delirium in order to inform an effective intervention.

Introduction The ARRISA-UK trial is investigating whether, compared to usual care, a GP practice-level complex intervention decreases the proportion of ‘at-risk’ asthma patients who experience asthma-related A&E attendances, hospitalisations or death over 12 months. This presentation reports initial findings from a nested process evaluation. Methods ARRISA-UK is a nationwide cluster-randomised controlled trial of an intervention involving identification and flagging of at-risk asthma patients’ electronic records and web-based training of practice staff to support implementation of actions in response to the flags (e.g. improved access and opportunistic care). A mixed-methods process evaluation is exploring intervention implementation, mechanisms of action and the influence of contextual factors (e.g. practice characteristics). Quantitative and qualitative data from questionnaires, training software, practice-specific action plans and staff focus groups/interviews were analysed to describe practice characteristics, and their engagement with, and initial implementation and experiences of, the ARRISA-UK approach. Results The 275 recruited practices, from across 14 English Clinical Research Network Regions, 7 Welsh and 5 Scottish Health Boards, had a median list size of 8801 (range 1667–37800) and identified 10,000+ at-risk asthma patients in total, representing an average of 33 (range 1–197) and 6% (range 0.2–13%) of registered asthma patients per practice. There was considerable variation in the characteristics of the 139 intervention practices (Table 1). Despite some early documented difficulties with technology and staff turnover, at least 409 staff (GPs, nurses, receptionists/administrators, dispensers/pharmacists) from 131 (94%) practices completed at least minimum individual on-line training, reflecting a median of 3 (maximum of 9) staff per practice. 128 (92%) practices also completed group training to prepare Action Plans, attended a webinar and activated flagging. Action plans varied in content and detail but illustrated ways for staff to enhance access to, and uptake of, asthma-related services by at-risk patients. Questionnaires suggested the training was generally well-received. Analyses of staff focus groups/interviews are underway. Conclusions The ARRISA-UK intervention represents a pragmatic, practice-wide approach to targeting at-risk asthma patients which has been successfully implemented across a variety of GP practices and generally engaged and been well-received by all practice staff groups. Initial findings have informed ongoing quantitative and qualitative data collection.

BACKGROUND: Cervical ripening is commonly needed for labor induction. Finding an optimal route of misoprostol dosing for efficacy, safety, and patient satisfaction is important and not well studied for the buccal route. OBJECTIVE: To compare the efficacy and safety of vaginal and buccal misoprostol for women undergoing labor induction at term. STUDY DESIGN: The IMPROVE trial was an institutional review boarde-approved, triple-masked, placebo-controlled randomized noninferiority trial for women undergoing labor induction at term with a Bishop score ≤6. Enrolled women received 25 mcg (first dose), then 50 mcg (subsequent doses) of misoprostol by assigned route (vaginal or buccal) and a matching placebo tablet by the opposite route. The primary outcomes were time to delivery and the rate of cesarean delivery performed urgently for fetal nonreassurance. A sample size of 300 was planned to test the noninferiority hypothesis. RESULTS: The trial enrolled 319 women, with 300 available for analysis, 152 in the vaginal misoprostol group and 148 in the buccal. Groups had similar baseline characteristics. We were unable to demonstrate noninferiority. The time to vaginal delivery was lower for the vaginal misoprostol group (median [95% confidence interval] in hours: vaginal: 20.1 [18.2, 22.8] vs buccal: 28.1 [24.1, 31.4], log-rank test P = .006, P(noninferiority) = .663). The rate of cesarean deliveries for nonreassuring fetal status was 3.3% for the vaginal misoprostol group and 9.5% for the buccal misoprostol group (P = .033). The rate of vaginal delivery in

Background Essential tremor (ET) is associated with physical and cognitive impairments, as well as embarrassment, avoidance of social settings, and related difficulties that negatively impact the lives of patients. In similar disease contexts, burden on friends and relatives acting as caregivers has been noted and has well-documented implications. There has been no study examining caregiver burden related to ET. Methods Data were gathered from 55 ET participants enrolled in a clinical study and their caregivers. The Zarit Burden Interview (ZBI-12) was used to assess caregiver burden. To assess clinical features that may be associated with burden, we collected several variables including the Montreal Cognitive Assessment (MoCA), self-reported tremor disability, a videotaped neurological examination, questionnaires assessing ET participants’ suffering, caregivers’ perceptions of that suffering, and both caregiver and ET participant depressive symptoms. Spearman’s correlations were performed between caregiver burden and clinical features, and we created a multivariate linear regression model predicting caregiver burden. Results Many ET caregivers provide little to no care and experience little to no burden. However, some caregivers (11%) provide over 25 hours of care/week, and 13% experience high levels of burden. Caregivers most commonly provided assistance with writing and cooking. Increased burden was associated with the ET participants’ decreased cognition, more caregiving tasks, more hours/week of caregiving activities, a longer duration of care, more ET participant falls/year, more medications taken by the ET participant, and more depressive symptoms in both the ET participant and the caregiver (all p

Background: Essential tremor (ET) is not exclusively a tremor disorder; it is also associated with cognitive and gait dysfunction. However, a gap in knowledge is that the relationship between cognitive and gait dysfunction has not been studied in detail in ET. We examined the relationship between cognition and balance and falls in ET, and hypothesized that cognitive dysfunction in ET patients would be associated with greater problems with balance and more falls. Methods: ET cases were recruited into the Clinical-pathological Study of Cognition in Essential Tremor. A comprehensive cognitive assessment was performed. This included the Montreal Cognitive Assessment (MoCA) to measure global cognition, multiple motor-free tests comprehensively assessing performance in each cognitive domain, and an assignment of Clinical Dementia Rating (CDR) scores. We collected data on the number of reported falls in the past year, and balance confidence was assessed using the six-item Activities of Balance Confidence Scale. These cross-sectional analyses utilized baseline data. Results: There were 199 ET cases (mean age 78.6 years). In linear regression models that considered the effects of numerous confounding variables, lower global cognition (poorer cognition) was associated with greater number of falls and reduced balance confidence (p

Background: Gene discovery has provided remarkable biological insights into amyotrophic lateral sclerosis (ALS). One challenge for clinical application of genetic testing is critical evaluation of the significance of reported variants. Methods: We use whole exome sequencing (WES) to develop a clinically relevant approach to identify a subset of ALS patients harboring likely pathogenic mutations. In parallel, we assess if DNA methylation can be used to screen for pathogenicity of novel variants since a methylation signature has been shown to associate with the pathogenic C9orf72 expansion, but has not been explored for other ALS mutations. Australian patients identified with ALS-relevant variants were cross-checked with population databases and case reports to critically assess whether they were “likely causal,” “uncertain significance,” or “unlikely causal.”. Results: Published ALS variants were identified in >10% of patients; however, in only 3% of patients (4/120) could these be confidently considered pathogenic (in SOD1 and TARDBP). We found no evidence for a differential DNA methylation signature in these mutation carriers. Conclusions: The use of WES in a typical ALS clinic demonstrates a critical approach to variant assessment with the capability to combine cohorts to enhance the largely unknown genetic basis of ALS Refereed/Peer-reviewed

INTRODUCTION: Amyotrophic lateral sclerosis (ALS) or motor neuron disease is a rapidly progressive neurodegenerative disorder. The primary involvement is of motor neurons in the brain, spinal cord and peripherally. There is secondary weakness of muscles and primary involvement of other brain regions, especially involving cognition. SOURCES OF DATA: Peer-reviewed journal articles and reviews. PubMed.gov AREAS OF AGREEMENT: The pathogenesis of ALS remains largely unknown. There are a wide range of potential mechanisms related to neurodegeneration. An increasing number of genetic factors are recognized. AREAS OF CONTROVERSY: There remains controversy, or lack of knowledge, in explaining how cellular events manifest as the complex human disease. There is controversy as to how well cellular and animal models of disease relate to the human disease. GROWING POINTS: Large-scale international collaborative genetic epidemiological studies are replacing local studies. Therapies related to pathogenesis remain elusive, with the greatest advances to date relating to provision of care (including multidisciplinary management) and supportive care (nutrition and respiratory support). AREAS TIMELY FOR DEVELOPING RESEARCH: The identification of C9orf72 hexanucleotide repeats as the most frequent genetic background to ALS, and the association with frontotemporal dementia, gives the potential of a genetic background against which to study other risk factors, triggers and pathogenic mechanisms, and to develop potential therapies.

Purpose The responsibility for monitoring the safety of marketed medicines is shared between regulatory authorities and the pharmaceutical industry and is underpinned by legal obligations on both sides. Both marketing authorisation holders (MAHs) and regulators initially evaluate and investigate potential safety concerns, and then work together on further review as appropriate. We wanted to test the feasibility of enhanced interaction between MAH and regulator via a regular monthly, two-way communication of potential safety concerns between the MAHs and the Medicines and Healthcare Products Regulatory Agency (MHRA). It was envisaged that such a process would aid prioritisation and planning by both parties, avoid duplication of effort and support a collaborative approach for decision making. Methods Four MAHs took part in the pilot, which was conducted between July 2007 and June 2008. Potential safety concerns were exchanged on a monthly basis. The MAH/MHRA proposed a timeline for evaluation of each potential safety concern. The pilot did not include serious public health issues which are immediately reported to regulatory authorities. Results During the pilot, 136 potential safety concerns were exchanged. Thirteen per cent of these resulted in a change to product information for health professionals and patients. There was concurrence between the MAHs and MHRA on timelines proposed for evaluation. Conclusions The pilot proved feasible for the companies involved and indicated potential benefits of a system for avoiding duplication of effort and supporting a collaborative approach to planning and prioritisation of investigation of potential safety concerns between pharmaceutical industry and regulatory authorities. Copyright © 2009 John Wiley & Sons, Ltd. This article was published online on December 27, 2009. An error was subsequently identified. This notice is included in the online and print versions to indicate that both have been corrected (08/01/10).

Sir, Recently, Bannwarth and colleagues reported that mutations in CHCHD10 were causative of amyotrophic lateral sclerosis (ALS) and frontotemporal dementia (FTD), with compelling segregation data and functional investigations well supporting these findings (Bannwarth et al. , 2014). In a number of follow-up studies, CHCHD10 was screened in ALS, FTD and other neurodegenerative disorder cohorts—including autosomal dominant mitochondrial myopathy and late-onset spinal motor neuronopathy—and novel putative disease-causing variants were identified (Chaussenot et al. , 2014; Johnson et al. , 2014; Muller et al. , 2014; Ajroud-Driss et al. , 2015; Chio et al. , 2015; Kurzwelly et al. , 2015; Penttila et al. , 2015; Ronchi et al. , 2015; Zhang et al. , 2015). In particular, one variant, the Pro34Ser in exon 2, was reported by three studies to be present in >1% of ALS and FTD cases in Caucasian populations (Chaussenot et al. , 2014; Chio et al. , 2015; Ronchi et al. , 2015). In the context of ALS, this is a remarkable finding and would make the CHCHD10 Pro34Ser variant …

Objective: The purpose of this article is to describe women's experiences of hysterectomy and to identify their fears, concerns, and met as well as unmet health care needs. Design: Narrative data of women's hysterectomy experiences were collected via a written survey. Setting: Data were collected from women living in southeastern Wisconsin. Participants: Participants were 102 women who had undergone hysterectomy within the previous 2 years. The mean age of the women was 43 and mean time since hysterectomy was 13 months. Eighty percent of the women had undergone both hysterectomy and oophorectomy, and 78% were taking hormone replacement therapy. Main Outcome Measures: A questionnaire of women's hysterectomy needs and a demographic questionnaire were used to collect data via mail. The data from three open-ended questions were content analyzed. Results: Seven themes about women's experiences of hysterectomy were identified: (a) positive aspects, (b) hormone replacement therapy, (c) insufficient information, (d) changes in sexual feelings and functioning, (e) emotional support, (f) psychologic sequelae, and (g) feelings of loss. Conclusions: Women wanted treatment choices, a part in decision-making, accurate and useful information at an appropriate time, provider support, and access to professional and lay support systems. The essentials for hysterectomy care are outlined and include the characteristics of care that women desire, the informational content that women want, health care systems that support patient satisfaction, and the outcomes women want. JOGNN, 29, 33–42; 2000.

This article reflects on the current state of process evaluations of health behavior interventions and argues that evaluation practice in this area could be improved by drawing on the social science literature to a greater degree. While process evaluations of health behavior interventions have increasingly engaged with the social world and sociological aspects of interventions, there has been a lag in applying relevant and potentially useful approaches from the social sciences. This has limited the scope for health behavior process evaluations to address pertinent contextual issues and methodological challenges. Three aspects of process evaluations are discussed: the incorporation of contexts of interventions; engagement with the concept of “process” in process evaluation; and working with theory to understand interventions. Following on from this, the article also comments on the need for new methodologies and on the implications for addressing health inequalities.

Huntington's disease (HD) is a devastating neurodegenerative disorder caused by abnormal polyglutamine expansion in the huntingtin protein (Exp-Htt). Currently, there are no effective treatments for HD. We used bidirectional lentiviral transfer vectors to generate in vitro and in vivo models of HD and to test the therapeutic potential of vascular endothelial growth factor 165 (VEGF₁₆₅). Lentiviral-mediated expression of Exp-Htt caused cell death and aggregate formation in human neuroblastoma SH-SY5Y and rat primary striatal cultures. Lentiviral-mediated VEGF₁₆₅ expression was found to be neuroprotective in both of these models. Unilateral stereotaxic vector delivery of Exp-Htt vector in adult rat striatum led to progressive inclusion formation and striatal neuron loss at 10 weeks post-transduction. Coinjection of a lower dose VEGF₁₆₅ significantly attenuated DARPP-32(+) neuronal loss, enhanced NeuN staining and reduced Exp-Htt aggregation. A tenfold higher dose VEGF₁₆₅ led to overt neuronal toxicity marked by tissue damage, neovascularization, extensive astrogliosis, vascular leakage, chronic inflammation and distal neuronal loss. No overt behavioral phenotype was observed in these animals. Expression of VEGF₁₆₅ at this higher dose in the brain of wild-type rats led to early mortality with global neuronal loss. This report raises important safety concerns about unregulated VEGF₁₆₅ CNS applications.

BACKGROUND: Cesarean delivery is one of the most common surgical procedures performed by obstetricians. Infectious morbidity after cesarean delivery can have a tremendous impact on the postpartum woman's return to normal function and her ability to care for her baby. Despite the widespread use of prophylactic antibiotics, postoperative infectious morbidity still complicates cesarean deliveries. This is an update of a Cochrane Review first published in 2010 and subsequently updated in 2012, twice in 2014, in 2017 and 2018. OBJECTIVES: To determine if cleansing the vagina with an antiseptic solution before a cesarean delivery decreases the risk of maternal infectious morbidities, including endometritis and wound complications. We also assessed the side effects of vaginal cleansing solutions to determine adverse events associated with the intervention. SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth’s Trials Register, ClinicalTrials.gov, the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (7 July 2019), and reference lists of retrieved studies. SELECTION CRITERIA: We included randomized controlled trials (RCTs) and quasi‐RCTs assessing the impact of vaginal cleansing immediately before cesarean delivery with any type of antiseptic solution versus a placebo solution/standard of care on post‐cesarean infectious morbidity. Cluster‐RCTs were eligible for inclusion, but we did not identify any. We excluded trials that utilized vaginal preparation during labor or that did not use antibiotic surgical prophylaxis. We also excluded any trials using a cross‐over design. We included trials published in abstract form only if sufficient information was present in the abstract on methods and outcomes to analyze. DATA COLLECTION AND ANALYSIS: At least three of the review authors independently assessed eligibility of the studies. Two review authors were assigned to extract study characteristics, quality assessments, and data from eligible studies. MAIN RESULTS: We included 21 trials, reporting results for 7038 women evaluating the effects of vaginal cleansing (17 using povidone‐iodine, 3 chlorhexidine, 1 benzalkonium chloride) on post‐cesarean infectious morbidity. Trials used vaginal preparations administered by sponge sticks, douches, or soaked gauze wipes. The control groups were typically no vaginal preparation (17 trials) or the use of a saline vaginal preparation (4 trials). One trial did not report on any outcomes of interest. Trials were performed in 10 different countries (Saudi Arabia, Pakistan, Iran, Thailand, Turkey, USA, Egypt, UK, Kenya and India). The overall risk of bias was low for areas of attrition, reporting, and other bias. About half of the trials had low risk of selection bias, with most of the remainder rated as unclear. Due to lack of blinding, we rated performance bias as high risk in nearly one‐third of the trials, low risk in one‐third, and unclear in one‐third. Vaginal preparation with antiseptic solution immediately before cesarean delivery probably reduces the incidence of post‐cesarean endometritis from 7.1% in control groups to 3.1% in vaginal cleansing groups (average risk ratio (aRR) 0.41, 95% confidence interval (CI) 0.29 to 0.58; 20 trials, 6918 women; moderate‐certainty evidence). This reduction in endometritis was seen for both iodine‐based solutions and chlorhexidine‐based solutions. Risks of postoperative fever and postoperative wound infection are also probably reduced by vaginal antiseptic preparation (fever: aRR 0.64, 0.50 to 0.82; 16 trials, 6163 women; and wound infection: RR 0.62, 95% CI 0.50 to 0.77; 18 trials, 6385 women; both moderate‐certainty evidence). Two trials found that there may be a lower risk of a composite outcome of wound complication or endometritis in women receiving preoperative vaginal preparation (RR 0.46, 95% CI 0.26 to 0.82; 2 trials, 499 women; low‐certainty evidence). No adverse effects were reported with either the povidone‐iodine or chlorhexidine vaginal cleansing. Subgroup analysis suggested a greater effect with vaginal preparations for those women in labour versus those not in labour for four out of five outcomes examined (post‐cesarean endometritis; postoperative fever; postoperative wound infection; composite wound complication or endometritis). This apparent difference needs to be investigated further in future trials. We did not observe any subgroup differences between women with ruptured membranes and women with intact membranes. AUTHORS' CONCLUSIONS: Vaginal preparation with povidone‐iodine or chlorhexidine solution compared to saline or not cleansing immediately before cesarean delivery probably reduces the risk of post‐cesarean endometritis, postoperative fever, and postoperative wound infection. Subgroup analysis found that these benefits were typically present whether iodine‐based or chlorhexidine‐based solutions were used and when women were in labor before the cesarean. The suggested benefit in women in labor needs further investigation in future trials. There was moderate‐certainty evidence using GRADE for all reported outcomes, with downgrading decisions based on limitations in study design or imprecision. As a simple intervention, providers may consider implementing preoperative vaginal cleansing with povidone‐iodine or chlorhexidine before performing cesarean deliveries. Future research on this intervention being incorporated into bundles of care plans for women receiving cesarean delivery will be needed.

Background Dental caries remains a significant public health problem, prevalence being linked to social and economic deprivation. Occlusal surfaces of first permanent molars are the most susceptible site in the developing permanent dentition. Cochrane reviews have shown pit and fissure sealants (PFS) and fluoride varnish (FV) to be effective over no intervention in preventing caries. However, the comparative cost and effectiveness of these treatments is uncertain. The primary aim of the trial described in this protocol is to compare the clinical effectiveness of PFS and FV in preventing dental caries in first permanent molars in 6-7 year-olds. Secondary aims include: establishing the costs and the relative cost-effectiveness of PFS and FV delivered in a community/school setting; examining the impact of PFS and FV on children and their parents/carers in terms of quality of life/treatment acceptability measures; and examining the implementation of treatment in a community setting. Methods/design The trial design comprises a randomised, assessor-blinded, two-arm, parallel group trial in 6–7 year old schoolchildren. Clinical procedures and assessments will be performed at 66 primary schools, in deprived areas in South Wales. Treatments will be delivered via a mobile dental clinic. In total, 920 children will be recruited (460 per trial arm). At baseline and annually for 36 months dental caries will be recorded using the International Caries Detection and Assessment System (ICDAS) by trained and calibrated dentists. PFS and FV will be applied by trained dental hygienists. The FV will be applied at baseline, 6, 12, 18, 24 and 30 months. The PFS will be applied at baseline and re-examined at 6, 12, 18, 24, and 30 months, and will be re-applied if the existing sealant has become detached/is insufficient. The economic analysis will estimate the costs of providing the PFS versus FV. The process evaluation will assess implementation and acceptability through acceptability scales, a schools questionnaire and interviews with children, parents, dentists, dental nurses and school staff. The primary outcome measure will be the proportion of children developing new caries on any one of up to four treated first permanent molars. Discussion The objectives of this study have been identified by the National Institute for Health Research as one of importance to the National Health Service in the UK. The results of this trial will provide guidance on which of these technologies should be adopted for the prevention of dental decay in the most susceptible tooth-surface in the most at risk children. Trial registrations ISRCTN ref: ISRCTN17029222 EudraCT: 2010-023476-23 UKCRN ref: 9273

This article argues that in public health research, standard approaches to knowledge translation are based on (1) an invalid model of the relationship between research knowledge and policy and (2) an oversimplified concept of ‘knowledge’. Standard approaches tend to focus primarily on communicating research knowledge to policy makers in order to increase the impact of research on policy making.1 ,2 However, the process of policy making is complex and political (in the broad sense); it is not a neutral or technical exercise that simply requires greater use of scientific evidence to improve decision making. Neither is research knowledge neutral or wholly technical; it is produced in social contexts and also operates in societies in uneven ways. There is significant socio-political literature which has analysed the relationship between knowledge and policy, including how they are embedded in social and political contexts, but this is rarely drawn on in public health research.3–6 Knowledge translation in public health is a challenging area which could be informed by this literature; key ideas are briefly outlined here.

Emergency department (ED) crowding is a national crisis that contributes to medical error and system inefficiencies. There is a natural concern that crowding may also adversely affect undergraduate and graduate emergency medicine (EM) education. ED crowding stems from a myriad of factors, and individually these factors can present both challenges and opportunities for education. Review of the medical literature demonstrates a small body of evidence that education can flourish in difficult clinical environments where faculty have a high clinical load and to date does not support a direct deleterious effect of crowding on education. To provide a theoretical framework for discussing the impact of crowding on education, the authors present a conceptual model of the effect of ED crowding on education and review possible positive and negative effects on each of the six recognized Accreditation Council for Graduate Medical Education (ACGME) core competencies.

The recent article on feeding patients with tracheostomies was of great interest to our team, as we manage acute cervical spinal cord injury (CSCI) patients requiring respiratory support via tracheostomy. We appreciate that the paper acknowledges multi-disciplinary team (MDT) decision-making and expert assessment to include flexible endoscopic evaluation of swallowing (FEES), which is a therapeutic approach to dysphagia management. There are several issues to pick up from your article: We agree that the evidence on the impact of tracheostomies on swallowing is poor, but consider the primary diagnosis to be the over-riding factor with regard to the effect on laryngeal function. This should be carefully assessed using objective, instrumental assessment. The limitations of the blue dye test were acknowledged in your paper. We do not use this test within our unit. The sensitivity of this test is poor and tells us no information as to why or when the patient aspirated. We have seen a number of patients transferred to our hospital who have been eating and drinking orally but who present with disordered swallow patterns and compensatory behaviours. Further assessment and discussions have revealed subtle food avoidances, prolonged mealtimes, choking and avoidance of social occasions, which result in longer term issues. The clinical aim should be not only to promote oral intake but also to ensure that swallow function is as close to normal swallow physiology as possible. For our team this includes normalising upper airflow through employing cuff deflation, which has the added advantage of allowing verbal communication. Critically ill patients are usually unable to maintain adequate oral intake to meet their metabolic demands. Current evidence suggests that enteral nutrition, initiated early, may serve therapeutic roles beyond providing calories and protein as discussed at the recent Intensive Care Society State of the Art meeting in the UK. The goal should always be for safe oral feeding with a nasogastric tube (NGT) being a short term solution. A recent study has highlighted the specific impact of NGTs and although a small sample, this has also been seen in clinical practice under fibreoptic nasendoscopy. For high cervical SCI patients who have evidence of dysphagia, we recommend transition to gastrostomy feeding, which provides additional support for fluid management and administration of medication until full return to oral intake supported by speech and language therapy intervention. The acute tetraplegic population are known to be silent aspirators and often have poor sensation within the pharynx and larynx. The high risk of aspiration and consequent respiratory compromise makes this a vulnerable patient group. We are currently undertaking a study that looks at the clinical decisions that are made in intensive care around managing nutrition, swallowing and respiratory function in CSCI, called the DAISY project (www.daisyproject.info). Feedback from patients reflecting on their critical care management, report confusion and frustration when transferred to different units with varied clinical approaches to feeding. Consistency is very important and it would be valuable to establish nationwide agreement and guidelines for practice.

Tobacco use during pregnancy continues to cause health problems for women and children. Nurses can facilitate smoking cessation during pregnancy through the use of tobacco control guidelines and counseling tailored to pregnant women. In this article, the Treating Tobacco Use and Dependence: Clinical Practice Guideline is reviewed; the Smoke Free Families program, which is tailored for pregnancy, stage matched, and includes second-hand smoke control assistance, is described; and two models for integrating smoking cessation counseling into prenatal services are offered.

Prostate cancer is a significant public health problem. In the European Union, approximately 200,000 men are diagnosed annually and the incidence is increasing, even allowing for the rise in screen-detected prostate cancer. Multiple aetiologies have been proposed to contribute to the development of prostate cancer. However, there is strong evidence that inherited genetic factors are important and contribute to significant familial aggregation in some men, particularly when affected at a young age (Woolf et al., 1960; Steinberg et al., 2000; Singh, 2000; Edwards et al., 2003). The breast cancer predisposition genes BRCA2, and possibly also BRCA1, have been reported to increase the risk of prostate cancer in male carriers of these genes; however, the prostate cancer risk associated with carriage of BRCA gene mutations remains uncertain. IMPACT (Identification of Men with a genetic Predisposition to ProstAte Cancer: Targeted screening in BRCA1 and BRCA2 mutation carriers and controls) is the first multinational study to investigate screening and diagnosis for men with a genetic risk of prostate cancer. An international collaboration which currently involves over 20 countries, the study aims to identify and recruit 850 male BRCA1/BRCA2 mutation carriers, and an equal number of controls (men with a negative predictive BRCA1/2 genetic test), into a targeted screening programme for prostate cancer. IMPACT aims to determine the sensitivity and specificity of PSA screening for prostate cancer in BRCA1/2 carriers and controls, and to evaluate new screening markers for this disease. It also aims to gain a better understanding of the pathogenicity of prostate cancer in men with BRCA1 or BRCA2 mutations, and will attempt to identify new modifier genes or biomarkers for this population. BRCA1 and BRCA2 are the only genes, thus far, with an established role in increasing prostate cancer risk, but it has been suggested that a number of other genes exist which may predispose to prostate cancer (each accounting for a proportion of familial prostate cancer clusters). With the establishment of a solid IMPACT consortium, it is hoped this study could be extended to investigate other prostate cancer predisposition genes if and when they are identified. Cancer research has been targeted as a high priority for the European Community (EC); however, research is most successful when centralised and well co-ordinated, avoiding the duplication and fragmentation associated with smaller, isolated studies. The EC Framework 6 Programme, which aims to facilitate co-operation between European countries in the field of cancer research, has therefore provided funding for IMPACT to be expanded to include clinical and research teams in Bulgaria, Romania and Turkey (and other Associated Candidate Countries and New Member States of the EU). A subteam of IMPACT, known as AIDIT (Advancing International Co-operation and Developing Infrastructure for Targeted Screening of Prostate Cancer in Men with Genetic Predisposition), will focus on linking researchers in these new countries with the established international IMPACT Consortium. The EC's support of AIDIT provides the opportunity for teams who might be new to research in genetics or oncology to become integrated into an existing study. Communication between new and existing collaborators will allow the sharing of knowledge and formulation of strategies to overcome local barriers and challenges. The AIDIT team is in the process of establishing a website to facilitate communication between current and potential project collaborators. It will also fund and facilitate an international conference to bring together research teams, clinicians and policy makers from across Europe. The project also aims to raise awareness of familial prostate cancer among health professionals and the public within Associated Candidate Countries and New Member States of the EU. Clinical and research teams who are interested in participating in IMPACT or who would like to attend the funded conference in Poland from 28 to 30 November are encouraged to contact the AIDIT administrator (email: ku.ca.rci@yduts-tcapmi or telephone +44 (0) 208 661 3897). This publication reflects only the authors' views. The European Community is not liable for any use that may be made of the information contained herein. The information in this document is provided as is and no guarantee or warranty is given that the information is fit for any particular purpose. The user hereof uses the information at its sole risk and liability.