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Vaginal lubricants are commonly used to aid sexual pleasure and/or to help combat vaginal dryness and dyspareunia. Several studies have reported their impact on sperm function, however there are no published guidelines to help healthcare professionals and couples select a vaginal lubricant that is 'sperm-safe'. To address this, we conducted a literature search using both PubMed and Scopus to identify and appraise manuscripts that reported the impact of lubricants on sperm function. We did not restrict the literature search by year of publication, and we only included manuscripts that looked at the impact of vaginal lubricants on human sperm. The quality of the eligible studies was assessed using the Björndahl et al., (2016) checklist for semen analysis, as most of the studies reported the findings of a basic semen analysis. A total of 24 articles were eligible for analysis with a total of 35 vaginal lubricants (that were available to buy over the counter) being included, 2 of which studied the effect of vaginal lubricants on sperm function in vivo, and 22 being conducted in vitro . KY Jelly, PreSeed and Astroglide were most studied, with most manuscripts focussing on their impact on sperm motility. A paucity of data on most lubricants combined with methodological variations between studies and limited/no reporting on pregnancy outcomes means greater efforts are required before an evidence-based guideline can be published.

Objectives: To explore local induction of labour pathways in the UK National Health Service to provide insight into current practice., Design: National survey., Setting: Hospital maternity services in all four nations of the UK., Sample: Convenience sample of 71 UK maternity units., Methods: An online cross-sectional survey was disseminated and completed via a national network of obstetrics and gynaecology specialist trainees (October 2021-March 2022). Results were analysed descriptively, with associations explored using Fisher's Exact and ANOVA., Main Outcome Measures: Induction rates, criteria, processes, delays, incidents, safety concerns., Results: 54/71 units responded (76%, 35% of UK units). Induction rate range 19.2%-53.4%, median 36.3%. 72% (39/54) had agreed induction criteria: these varied widely and were not all in national guidance. Multidisciplinary booking decision-making was not reported by 38/54 (70%). Delays reported 'often/always' in hospital admission for induction (19%, 10/54) and Delivery Suite transfer once induction in progress (63%, 34/54). Staffing was frequently reported cause of delay (76%, 41/54 'often/always'). Delays triggered incident reports in 36/54 (67%) and resulted in harm in 3/54 (6%). Induction was an area of concern (44%, 24/54); 61% (33/54) reported induction-focused quality improvement work., Conclusions: There is substantial variation in induction rates, processes and policies across UK maternity services. Delays appear to be common and are a cause of safety concerns. With induction rates likely to increase, improved guidance and pathways are critically needed to improve safety and experience of care., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2024 Taylor et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Fluidic channels at atomic scales regulate cellular trafficking and molecular filtration across membranes, and thus play crucial roles in the functioning of living systems. However, constructing synthetic channels experimentally at these scales has been a significant challenge due to the limitations in nanofabrication techniques and the surface roughness of the commonly used materials. Angstrom (Å)-scale slit-like channels overcome such challenges as these are made with precise control over their dimensions and can be used to study the fluidic properties of gases, ions and water at unprecedented scales. Here we provide a detailed fabrication method of the two-dimensional Å-scale channel devices that can be assembled to contain a desired number of channels, a single channel or up to hundreds of channels, made with atomic-scale precision using layered crystals. The procedure includes the fabrication of the substrate, flake, spacer layer, flake transfers, van der Waals assembly and postprocessing. We further explain how to perform molecular transport measurements with the Å-channels to directly probe the intriguing and anomalous phenomena that help shed light on the physics governing ultra-confined transport. The procedure requires a total of 1-2 weeks for the fabrication of the two-dimensional channel device and is suitable for users with prior experience in clean room working environments and nanofabrication., (© 2023. Springer Nature Limited.)

Objectives: To analyze Australian national data to examine the impact of the coronavirus disease 2019 (COVID-19) pandemic on mental health-related hospital presentations among children and adolescents during the pandemic period with restrictions, and the period after the restrictions eased., Methods: We analyzed the monthly mental health-related inpatient admissions and emergency department (ED) attendances data from 6 large pediatric hospitals across Australia, using the Bayesian structural time series models. The COVID-19 restriction period was from March 2020 to December 2021 and the COVID-19 restriction-eased period from January to June 2022., Results: A total of 130 801 mental health-related hospital admissions (54 907) and ED attendances (75 894) were analyzed. During the COVID-19 restriction period, there was a significant increase in inpatient admissions related to deliberate self-harm behaviors (82%, 95% credible interval [CrI], 7%-160%) and ED attendances related to overall mental health disorders (15%, 95% CrI, 1.1%-30%) and eating disorders (76%, 95% CrI, 36%-115%). The increase was higher among females and those living in the least socioeconomically disadvantaged areas, suggesting a widening gap between mental health-related presentations by sex and socioeconomic status. After the restrictions eased, there were slight declines in mental health-related hospital presentations; however, the numbers remained higher than the pre-COVID-19 levels., Conclusions: The increase in mental health-related hospital presentations during the COVID-19 period calls for additional support for pediatric mental health care, particularly for eating disorders and deliberate self-harm among female adolescents. It is important to monitor pediatric mental health service use as we enter "COVID-19 normal" period.

There has been significant investment in research and development in respect of metal 3D printing in the United States (as well as a number of other jurisdictions). There has been growing conflict over the ownership of intellectual property in respect of metal 3D printing (involving not only patents but also trade secrets and confidential information, as well as contract law and unfair competition). In 2018, Desktop Metal Inc. launched litigation against Markforged Inc. and Matiu Parangi in relation to intellectual property and metal 3D printing in the United States. As well as complaints of patent infringement, Desktop Metal Inc. has alleged that the defendants had engaged in acts of trade secret misappropriation, unfair and deceptive business practices, and breach of contract. Markforged Inc. made various counter-claims of its own. In July 2018, a Federal Jury found that Markforged Inc. did not infringe two patents held by its rival Desktop Metal Inc. Claims of further violations of trade secrets and contract law were also considered. In the end, the dispute was settled, with neither party obtaining an advantage in the litigation. There was further conflict over whether the terms of the settlement in respect of non-disparagement were honored. The parties have also faced further intellectual property conflict. In 2021, Continuous Composites has filed a patent infringement lawsuit against Markforged Inc. In 2021, Desktop Metal Inc. brought legal action against SprintRay in Germany. Drawing upon this case study, this paper considers whether metal 3D printing will disrupt patent law, policy, and practice. It also explores the tension between the use of trade secrets in commercial 3D printing (such as in metal 3D Printing), and the open source ethos of the Maker Movement. This paper considers the larger implications of this intellectual property dispute over metal 3D printing for scarcity, regulation, and the abundance society. It also explores the innovation policies of the Biden administration in respect of advanced manufacturing-with a focus upon metal 3D printing and additive manufacturing., Competing Interests: The author declares that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 Rimmer.)

Background: Slowing climate change is crucial to the future wellbeing of human societies and the greater environment. Current beef production systems in the USA are a major source of negative environmental impacts and raise various animal welfare concerns. Nevertheless, beef production provides a food source high in protein and many nutrients as well as providing employment and income to millions of people. Cattle farming also contributes to individual and community identities and regional food cultures. Novel plant-based meat alternatives have been promoted as technologies that could transform the food system by reducing negative environmental, animal welfare, and health effects of meat production and consumption. Recent studies have conducted static analyses of shifts in diets globally and in the USA, but have not considered how the whole food system would respond to these changes, nor the ethical implications of these responses. We aimed to better explore these dynamics within the US food system and contribute a multiple perspective ethical assessment of plant-based alternatives to beef., Methods: In this national modelling analysis, we explored multiple ethical perspectives and the implications of the adoption of plant-based alternatives to beef in the USA. We developed USAGE-Food, a modified version of USAGE (a detailed computable general equilibrium model of the US economy), by improving the representation of sector interactions and dependencies, and consumer behaviour to better reflect resource use across the food system and the substitutability of foods within households. We further extended USAGE, by linking estimates of the environmental footprint of US agriculture, to estimate how changes across the agriculture sector could alter the environmental impact of primary food production across the whole sector, not only the beef sector. Using USAGE-Food, we simulated four beef replacement scenarios against a baseline of current beef demand in the USA: BEEF10, in which beef expenditure is replaced by other foods and three scenarios wherein 10%, 30%, or 60% of beef expenditure is replaced by plant-based alternatives., Findings: The adoption of plant-based beef alternatives is likely to reduce the carbon footprint of US food production by 2·5-13·5%, by reducing the number of animals needed for beef production by 2-12 million. Impacts on other dimensions are more ambiguous, as the agricultural workforce and natural resources, such as water and cropland, are reallocated across the food system. The shifting allocation of resources should lead to a more efficient food system, but could facilitate the expansion of other animal value chains (eg, pork and poultry) and increased exports of agricultural products. In aggregate, these changes across the food system would have a small, potentially positive, impact on national gross domestic product. However, they would lead to substantial disruptions within the agricultural economy, with the cattle and beef processing sectors decreasing by 7-45%, challenging the livelihoods of the more than 1·5 million people currently employed in beef value chains (primary production and animal processing) in the USA., Interpretation: Economic modelling suggests that the adoption of plant-based beef alternatives can contribute to reducing greenhouse gas emissions from the food system. Relocation of resources across the food system, simulated by our dynamic modelling approach, might mitigate gains across other environmental dimensions (ie, water or chemical use) and might facilitate the growth of other animal value chains. Although economic consequences at the country level are small, there would be concentrated losses within the beef value chain. Reduced carbon footprint and increased resource use efficiency of the food system are reasons for policy makers to encourage the continued development of these technologies. Despite this positive outcome, policy makers should recognise the ethical assessment of these transitions will be complex, and should remain vigilant to negative outcomes and be prepared to target policies to minimise the worst effects., Funding: The Stavros Niarchos Foundation, the Bill & Melinda Gates Foundation, Johns Hopkins University, the Commonwealth Scientific and Industrial Research Organisation, Cornell University, and Victoria University., Competing Interests: Declaration of interests We declare no competing interests., (Copyright © 2022 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.)

Introduction: A journal club (JC) is a commonly used medical educational tool. Videoconferencing technology can facilitate the delivery of JCs, however, there remains no evidence on the role of web-based virtual JCs in promoting the acquisition and retention of medical knowledge. The Web-Ed trial aims to evaluate the educational benefits, feasibility and acceptability of web-based virtual JCs compared with traditional face-to-face ones., Methods and Analysis: Web-Ed is a multicentre pragmatic parallel-group randomised trial across teaching hospitals within the UK National Health Service (NHS). We will enrol qualified doctors or medical students who are >18 years old, proficient in English and able to use online videoconferencing software. Block randomisation will be used to allocate participants in 1:1 ratio to either intervention group. Both groups will be presented with the same educational material and follow a standardised JC structure hosted by nominated moderators and medical faculty members.The primary outcome is the difference in participants' knowledge acquisition and retention 7 days after the JCs evaluated using standardised multiple-choice questions. We will report secondarily on the feasibility and acceptability of the JCs using Likert scale questionnaires. Assuming a 30% drop-out rate, we aim to enrol 75 participants to detect a 20% improvement in knowledge acquisition at 80% power and 5% significance. We will report using mean difference or risk ratio with 95% CIs and assess significance using parametric/non-parametric testing. Where relevant, we will adjust for predetermined characteristics (age, grade of training and session duration) using multivariate regression analyses., Ethics and Dissemination: Web-Ed was designed by doctors in training to address their learning needs and evaluate the preferred mode of learning. The trial results will be published in peer-reviewed journals and presented at relevant scientific conferences. The trial has been approved by the NHS Health Regulation Authority (21/HRA/3361)., Trial Registration Number: ISRCTN18036769., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: The coronavirus disease 2019 (COVID-19) pandemic is disrupting health services worldwide. We aimed to evaluate the provision of obstetrics and gynaecology services in the UK during the acute phase of the COVID-19 pandemic., Design: Interview-based national survey., Setting: Women's healthcare units in the National Health Service., Population: Junior doctors in obstetrics and gynaecology., Methods: Participants were interviewed by members of the UK Audit and Research in Obstetrics and Gynaecology trainees' collaborative between 28 March and 7 April 2020. We used a quantitative analysis for closed-ended questions and a thematic framework analysis for open comments., Results: We received responses from 148/155 units (95%), most of the participants were in years 3-7 of training (121/148, 82%). Most completed specific training drills for managing obstetric and gynaecological emergencies in women with COVID-19 (89/148, 60.1%) and two-person donning and doffing of Personal Protective Equipment (PPE) (96/148, 64.9%). The majority of surveyed units implemented COVID-19-specific protocols (130/148, 87.8%), offered adequate PPE (135/148, 91.2%) and operated dedicated COVID-19 emergency theatres (105/148, 70.8%). Most units reduced face-to-face antenatal clinics (117/148, 79.1%) and suspended elective gynaecology services (131/148, 88.5%). The 2-week referral pathway for oncological gynaecology was not affected in half of the units (76/148, 51.4%), but half reported a planned reduction in oncology surgery (82/148, 55.4%)., Conclusion: The provision of obstetrics and gynaecology services in the UK during the acute phase of the COVID-19 pandemic seems to be in line with current guidelines, but strategic planning is needed to restore routine gynaecology services and ensure safe access to maternity care in the long term., Tweetable Abstract: Provision of obstetrics and gynaecology services during the acute phase of COVID-19 is in line with current guidelines, strategic planning is needed to restore routine services and ensure safe access to care in the long term., (© 2020 The Authors. BJOG: An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd on behalf of Royal College of Obstetricians and Gynaecologists.)

Polycystic ovary syndrome (PCOS) is a risk factor for dysglycemia, insulin resistance, and type 2 Diabetes Mellitus (T2DM). Inefficient energy oxidation, metabolic inflexibility, is a marker of blunted metabolism. We conducted a systematic review on metabolic inflexibility in women with PCOS. We searched MEDLINE, EMBASE and Cochrane central (inception-October 2018) for studies evaluating metabolic inflexibility and reporting on changes in Respiratory Quotient (ΔRQ). We extracted data and assessed quality using The Newcastle-Ottawa Scale. We included five prospective cohort studies (461 women). Three compared PCOS women to unaffected subjects, one to women with obesity or T2DM, and one to adolescent girls; all had medium quality. Three studies showed higher metabolic inflexibility in women with PCOS (ΔRQ range 0.05-0.098) compared to unaffected subjects. Women with PCOS had similar metabolic inflexibility compared to those with T2DM (ΔRQ 0.05 ± 0.03 vs 0.06 ± 0.04, p  = .98) and obesity ( p  = .06). Inflexibility was higher in hyperandrogenemic women with PCOS (ΔRQ 0.091 ± 0.060 vs 0.120 ± 0.010, p  = .014). ΔRQ was lower in PCOS women with insulin resistance vs those with normal insulin sensitivity (0.04 ± 0.02 vs. 0.07 ± 0.04, p  = .007). In conclusion, women with polycystic ovary syndrome appear to have higher metabolic inflexibility associated with hyperandrogenemia and insulin resistance.

Objective: This review aimed to evaluate the current evidence for what impact different Liaison Psychiatry (LP) services are having on Emergency Departments (ED). Mental Health (MH) problems contribute to 12 million annual US ED attendances and 5% in the UK., Methods: Databases were searched for articles describing LP services for adult MH patients attending EDs which reported ED care-related outcomes, published since 2000. Articles were screened and relevant articles quality assessed and narratively synthesized., Results: 3653 articles were identified and 17 included in the review. Study designs were overall of poor-moderate quality, using retrospective before-and-after study designs. LP services were categorized into four models. Models with MH personnel integrated into the ED team or triage reduced patient waiting time to be seen, may reduce patients leaving without being seen and have high staff satisfaction. Co-located MH space or personnel reduced patient waiting times. Care agreements with existing psychiatry teams don't affect waiting times or ED length of stay. Transferring patients to external services reduces patients' time in the ED. There is insufficient evidence about patient satisfaction, costs, and onward care., Conclusions: Waiting times are shortened by MH personnel integrated into the ED and are more satisfactory to staff than other LP models. The involvement of a psychiatrist in the LP team improves the care quality. All models may improve safety for patients but most evaluations are of poor quality and therefore there is still insufficient evidence to recommend one service model over another and further robust research is required., (Copyright © 2019. Published by Elsevier Inc.)

Background: People with intellectual disabilities (ID) may not be able to access and respond to uniformly delivered health interventions. Public bodies have a legal duty to make 'reasonable adjustments' to policies and practices to provide fair access and treatment for people with ID. This study aimed to identify adjustments to the Slimming World weight management programme to improve accessibility and assess acceptability and feasibility for this population., Methods: This user-centred qualitative study was carried out with a steering group of people with ID (n = 4). Barriers and facilitators to using Slimming World were identified through interviews and focus groups with people with ID (n = 54), carers (n = 12) current members with ID (n = 8) and Slimming World group leaders (n = 11). Adjustments were made and their feasibility and acceptability were explored in a before-and-after mixed methods study where people with ID attended Slimming World for eight weeks. Participants (n = 9), carers (n = 7) and Slimming World group leaders (n = 4) were interviewed to explore their experiences of the adjustments. Participants were weighed at baseline then each week., Results: Four key adjustments were identified and addressed by Slimming World who developed prototype Easy Read materials and a letter for carers. Six of the nine participants attended Slimming World for eight weeks and lost weight (1.4 kg to 6.6 kg, reduction in BMI between 0.5 and 1.7 kg/m2), indicating that the adjustments were feasible and acceptable. Two participants dropped out because they felt uncomfortable in a mainstream group and another left because they lacked control over food choice in their residential setting., Conclusions: This user-centred approach identified reasonable adjustments that were feasible to implement. In a small uncontrolled feasibility study, people with ID were positive about the adjustments and lost weight. However, issues in the wider context of people's lives, such as obesogenic environments and concerns about joining mainstream groups, limited the acceptability of Slimming World even with these adjustments. These findings have important implications for policy and suggest that environmental and organisational level interventions are needed alongside those targeting individual behaviour to tackle the obesogenic environment in which many people with ID spend their time, in order to reduce inequalities associated with the consequences of obesity.

Purpose: The purpose of this paper is to report how an evaluation tool originally developed for Age-Friendly Cities was pilot-tested in the context of the Dementia Friendly Community (DFC) initiative of the city of Sheffield/UK. It presents finding and outputs on which other communities with dementia friendly agendas can draw., Design/methodology/approach: The original evaluation tool was adapted to a focus on dementia friendliness. Data collection involved scoping conversations, documentary analysis, interviews and group discussions. Following evidence appraisal, Sheffield's approach to dementia friendliness was assessed. A local steering group was central to the study., Findings: The evidence indicates areas of strength in Sheffield's approach to dementia friendliness: involvement of older people; service provision; collaboration; monitoring and evaluation. Scope for improvement was identified around resource allocation, and use of existing guidance on dementia friendliness. Recommendations for policy and practice include enhancing pooling of resources, more detailed recording of resources allocated to dementia-related activity, and collection of evidence on how people affected by dementia have shaped the city's DFC initiative. Key research outputs are an adaptable logic model and an emerging evaluation framework for DFCs., Research Limitations/implications: The study was a short pilot with limited resources. Its findings and outputs must be considered preliminary., Originality/value: The findings and outputs provide a basis for further research. The study has suggested key components of an evaluation framework for DFCs. It is informing ongoing work to develop such a framework.

Background: There is growing consensus on the importance of identifying age-related inequities in the receipt of public health and healthcare interventions, but concerns regarding conceptual and methodological rigour in this area of research. Establishing age inequity in receipt requires evidence of a difference that is not an artefact of poor measurement of need or receipt; is not warranted on the grounds of patient preference or clinical safety; and is judged to be unfair., Method: A systematic, thematic literature review was undertaken with the objective of characterising recent research approaches. Studies were eligible if the population was in a country within the Organisation for Economic Co-operation and Development and analyses included an explicit focus on age-related patterns of healthcare receipt including those 60 years or older. A structured extraction template was applied. Extracted material was synthesised in thematic memos. A set of categorical codes were then defined and applied to produce summary counts across key dimensions. This process was iterative to allow reconciliation of discrepancies and ensure reliability., Results: Forty nine studies met the eligibility criteria. A wide variety of concepts, terms and methodologies were used across these studies. Thirty five studies employed multivariable techniques to produce adjusted receipt-need ratios, though few clearly articulated their rationale, indicating the need for great conceptual clarity. Eighteen studies made reference to patient preference as a relevant consideration, but just one incorporated any kind of adjustment for this factor. Twenty five studies discussed effectiveness among older adults, with fourteen raising the possibility of differential effectiveness, and one differential cost-effectiveness, by age. Just three studies made explicit reference to the ethical nature of healthcare resource allocation by age. While many authors presented suitably cautious conclusions, some appeared to over-stretch their findings concluding that observed differences were 'inequitable'. Limitations include possible biases in the retrieved material due to inconsistent database indexing and a focus on OECD country populations and studies with English titles., Conclusions: Caution is needed among clinicians and other evidence-users in accepting claims of healthcare 'ageism' in some published papers. Principles for improved research practice are proposed.

Background: older people may be less likely to receive interventions than younger people. Age bias in national guidance may influence entire public health and health care systems. We examined how English National Institute for Health & Care Excellence (NICE) guidance and guidelines consider age., Methods: we undertook a documentary analysis of NICE public health (n = 33) and clinical (n = 114) guidelines and technology appraisals (n = 212). We systematically searched for age-related terms, and conducted thematic analysis of the paragraphs in which these occurred ('age-extracts'). Quantitative analysis explored frequency of age-extracts between and within document types. Illustrative quotes were used to elaborate and explain quantitative findings., Results: 2,314 age-extracts were identified within three themes: age documented as an a-priori consideration at scope-setting (518 age-extracts, 22.4%); documentation of differential effectiveness, cost-effectiveness or other outcomes by age (937 age-extracts, 40.5%); and documentation of age-specific recommendations (859 age-extracts, 37.1%). Public health guidelines considered age most comprehensively. There were clear examples of older-age being considered in both evidence searching and in making recommendations, suggesting that this can be achieved within current processes., Conclusions: we found inconsistencies in how age is considered in NICE guidance and guidelines. More effort may be required to ensure age is consistently considered. Future NICE committees should search for and document evidence of age-related differences in receipt of interventions. Where evidence relating to effectiveness and cost-effectiveness in older populations is available, more explicit age-related recommendations should be made. Where there is a lack of evidence, it should be stated what new research is needed., (© The Author 2016. Published by Oxford University Press on behalf of the British Geriatrics Society.)

Background: Various physician- and patient-reported instruments exist for quantification of disease activity in inflammatory bowel diseases (IBD) but none are widely used in routine clinical practice. A simple patient-reported outcome measure might help inform clinical decision making. We evaluated a patient-reported 0 to 10 score of IBD activity (IBD-10) by correlation with conventional multicomponent activity indices., Methods: A single-center prospective cross-sectional study was conducted in ambulant patients with IBD. Patients were asked to verbally rate the control of Crohn's disease (CD) or ulcerative colitis (UC) on a numerical scale from 0 to 10, with 10 indicating perfect control. Disease activity was assessed using Harvey-Bradshaw index for CD and simple clinical colitis activity index for UC., Results: A total of 405 patients were included, of whom 209 (52%) had CD and 196 (48%) had UC. The median age was 41 (interquartile range, 27-55) years. IBD-10 correlated well with Harvey-Bradshaw Index (rs = -0.69, P < 0.001) and simple clinical colitis activity index (rs = -0.79, P < 0.001). An IBD-10 score of ≥7 predicted remission (defined by Harvey-Bradshaw index/simple clinical colitis activity index) with 90% sensitivity (95% confidence interval [CI], 86-94) and 75% specificity (95% CI, 67-82). The discriminatory ability of IBD-10 for remission was better for UC (area under the receiver operating characteristic curve, 0.93; 95% CI, 0.89-0.97) than for CD (area under the receiver operating characteristic curve, 0.86; 95% CI, 0.81-0.91; P = 0.035). An IBD-10 score of <7 correlated with treatment escalation., Conclusions: The IBD-10 score correlates well with more complex clinical activity indices. Correlation was less strong for CD than for UC, possibly reflecting a weaker link in CD between stool frequency and the patient perspective of disease activity. The IBD-10 score could readily be used in routine clinical practice.

Background: Demand management defines any method used to monitor, direct, or regulate patient referrals. Strategies have been developed to manage the referral of patients to secondary care, with interventions that target primary care, specialist services, or infrastructure., Aim: To review the international evidence on interventions to manage referral from primary to specialist care., Design and Setting: Systematic review., Method: Iterative, systematic searches of published and unpublished sources public health, health management, management, and grey literature databases from health care and other industries were undertaken to identify recent, relevant studies. A narrative synthesis of the data was completed to structure the evidence into groups of similar interventions., Results: The searches generated 8327 unique results, of which 140 studies were included. Interventions were grouped into four intervention categories: GP education (n = 50); process change (n = 49); system change (n = 38); and patient-focused (n = 3). It is clear that there is no 'magic bullet' to managing demand for secondary care services: although some groups of interventions may have greater potential for development, given the existing evidence that they can be effective in specific contexts., Conclusions: To tackle demand management of primary care services, the focus cannot be on primary care alone; a whole-systems approach is needed because the introduction of interventions in primary care is often just the starting point of the referral process. In addition, more research is needed to develop and evaluate interventions that acknowledge the role of the patient in the referral decision., (© British Journal of General Practice 2014.)

Background: There is increasing interest in innovative methods to carry out systematic reviews of complex interventions. Theory-based approaches, such as logic models, have been suggested as a means of providing additional insights beyond that obtained via conventional review methods., Methods: This paper reports the use of an innovative method which combines systematic review processes with logic model techniques to synthesise a broad range of literature. The potential value of the model produced was explored with stakeholders., Results: The review identified 295 papers that met the inclusion criteria. The papers consisted of 141 intervention studies and 154 non-intervention quantitative and qualitative articles. A logic model was systematically built from these studies. The model outlines interventions, short term outcomes, moderating and mediating factors and long term demand management outcomes and impacts. Interventions were grouped into typologies of practitioner education, process change, system change, and patient intervention. Short-term outcomes identified that may result from these interventions were changed physician or patient knowledge, beliefs or attitudes and also interventions related to changed doctor-patient interaction. A range of factors which may influence whether these outcomes lead to long term change were detailed. Demand management outcomes and intended impacts included content of referral, rate of referral, and doctor or patient satisfaction., Conclusions: The logic model details evidence and assumptions underpinning the complex pathway from interventions to demand management impact. The method offers a useful addition to systematic review methodologies., Trial Registration Number: PROSPERO registration number: CRD42013004037.

This article analyses some popular cultural representations of biotechnology, especially the artistic work of the Australian artist Patricia Piccinini to reflect on the role of law, technology and ethics in relation to bodily material. Her view that "with creation...comes an obligation to care for the result", so evident in her poignant pictures, is a sober reminder to us of our responsibilities in regulating new technologies.

Saracatinib (AZD0530) is an orally active once-daily Src kinase inhibitor which modulates key signaling pathways in cancer cells. In a Phase I study in patients with advanced solid malignancies resistant to standard treatment we assessed the effect of saracatinib on bone turnover. Fifty-one patients were randomized into three parallel groups to receive saracatinib 50, 125 or 175 mg/day. After a single dose followed by a 7-day washout, patients received once-daily doses for 21 days. Bone turnover markers were measured in serum and urine samples collected before dosing on days 1, 2, 3, 17 and 28. Samples were available at baseline and more than one other time point for 44 patients. Bone resorption markers were significantly decreased by saracatinib. Serum cross-linked C-terminal telopeptide of type I collagen (sCTX) changed in the 50, 125 and 175 mg/day groups by -36% (95% CI -58, -4), -64% (95% CI -75, -48) and -75% (95% CI -83, -61), respectively, at day 28. Urinary cross-linked N-terminal telopeptide of type I collagen/creatinine ratio (uNTX/Cr) changed in the 50, 125 and 175 mg/day groups by; -13% (95% CI -33, 13), -48% (95% CI -59, -34) and -50% (95% CI -62, -35), respectively, at day 28. The significant decreases in bone resorption markers indicate that suppression of Src kinase inhibits osteoclast activity in patients with advanced cancer. This result suggests that saracatinib may have therapeutic benefit in metastatic bone disease., (Copyright © 2012 Elsevier Inc. All rights reserved.)

Src is a nonreceptor tyrosine kinase thought to be essential for osteoclast function and bone resorption. We investigated the effect of the orally available Src inhibitor saracatinib (AZD0530) on bone turnover in healthy men. The study was part of a randomized, double-blind, placebo-controlled multiple-ascending-dose phase I trial of saracatinib. Fifty-nine healthy men (mean age 34.6 years) were divided into five cohorts; four with 12 subjects and one with 11 subjects, and randomized within each cohort in the ratio 3:1 to receive a single dose of saracatinib or placebo, respectively, followed 7 to 10 days later with daily doses for a further 10 to 14 days. Dosing levels of saracatinib ascended by cohort (60 to 250 mg). Markers of bone turnover were measured predose and 24 and 48 hours after the initial single dose and immediately before and 24 and 48 hours and 10 to 14 days after the final dose. Data from 44 subjects were included in the analysis. There was a dose-dependent decrease in bone resorption markers [serum cross-linked C-telopeptide of type I collagen (sCTX) and urinary cross-linked N-telopeptide of type I collagen normalized to creatinine (uNTX/Cr)]. At a dose of 250 mg (maximum tolerated dose), sCTX decreased by 88% [95% confidence interval (CI) 84-91%] and uNTX/Cr decreased by 67% (95% CI 53-77%) from baseline 24 hours after the final dose. There was no significant effect on bone formation markers. There were no significant adverse events. We conclude that inhibition of Src reduces osteoclastic bone resorption in humans. Saracatinib is a potentially useful treatment for diseases characterized by increased bone resorption, such as metastatic bone disease and osteoporosis., (Copyright 2010 American Society for Bone and Mineral Research.)

Background: Neurocognitive sequelae are among the most debilitating late effects experienced by survivors of childhood cancer, with far reaching consequences for educational, social, and adaptive development. Empirically validated interventions to address such disease and treatment related psychosocial morbidities are needed., Procedure: We conducted a pilot study to evaluate participants' acceptance and impact of a 15-session, clinic-based training program to teach compensatory learning and problem-solving skills in survivors with cognitive deficits. The intervention program consisted of 5 core components designed to improve daily problem solving, attention and memory, and academic performance., Results: A sample of 12 survivors completed the program. Virtually all objective performance scores showed gains from preintervention to postintervention in the expected positive direction, although only 2 of the gains were statistically significant. Parent responses indicated they perceived the skills taught to be useful, to have improved the child's problem-solving ability and learning skills, to have provided concrete and practical interventions for the home, and to have increased parental knowledge. Similarly, the children rated the overall program high, and reported satisfaction with learning more about their relative cognitive strengths and weaknesses and practical problem solving for academic difficulties., Conclusions: Although the majority of enrolled families completed at least 70% of the training sessions, the overall low participation rate from eligible families raise concern about widespread acceptance of such programs in the oncology clinic. The limitations of the study design and recommendations for future research are discussed.

Background: One hundred years ago psychiatrists thought that ear disease could cause insanity by irritation of the brain. Current understanding of the role of the temporal lobes in schizophrenia and their proximity to the middle ear supports this hypothesis., Aims: To establish the rate of middle-ear disease pre-dating the onset of schizophrenia., Method: Eighty-four patients with schizophrenia were each matched to four non-psychiatric controls by age, gender and season of birth. History of ear disease was obtained from general practice records. Additional information on symptoms was collected for participants in the case group, who also had audiometry., Results: The odds ratio of recorded middle-ear disease pre-dating schizophrenia was 3.68 (95% CI 1.86-7.28). This excess was particularly marked on the left (OR=4.15, 95% CI 2.08-8.29). Auditory hallucinations were associated with middle-ear disease but not with hearing loss., Conclusions: There is an association between middle-ear disease and schizophrenia which may have aetiological significance.

Aims: The Framework Convention on Tobacco Control (FCTC) requires nations that have ratified the convention to ban all tobacco advertising and promotion. In the face of these restrictions, tobacco packaging has become the key promotional vehicle for the tobacco industry to interest smokers and potential smokers in tobacco products. This paper reviews available research into the probable impact of mandatory plain packaging and internal tobacco industry statements about the importance of packs as promotional vehicles. It critiques legal objections raised by the industry about plain packaging violating laws and international trade agreements., Methods: Searches for available evidence were conducted within the internal tobacco industry documents through the online document archives; tobacco industry trade publications; research literature through the Medline and Business Source Premier databases; and grey literature including government documents, research reports and non-governmental organization papers via the Google internet search engine., Results: Plain packaging of all tobacco products would remove a key remaining means for the industry to promote its products to billions of the world's smokers and future smokers. Governments have required large surface areas of tobacco packs to be used exclusively for health warnings without legal impediment or need to compensate tobacco companies., Conclusions: Requiring plain packaging is consistent with the intention to ban all tobacco promotions. There is no impediment in the FCTC to interpreting tobacco advertising and promotion to include tobacco packs.

In this study, we examined the impact of a male opponent's pre-match body language and clothing (general vs. sports-specific) on how his performances were judged by an observer. Forty male tennis players viewed videos of a male target tennis player warming up and then observed playing footage of the target. Each participant viewed the target player warming up displaying one of four combinations of body language and clothing (positive body language/tennis-specific clothing; positive body language/general sportswear; negative body language/tennis-specific clothing; negative body language/general sportswear). Participants rated the performance of the tennis player and gave their perceptions of the likely outcome of a tennis match with the target player. Analyses of variance indicated that clothing and body language had an interactive effect on both outcome expectations and ratings of performance. The findings support the contention that the initial impressions athletes form of their opponents can influence the way in which they judge the performances of opponents and their perceived likelihood of success against the same opponents.

Background: Little is known about pain-related outcomes in surgical inpatients after discharge from the hospital. An ongoing risk and outcomes monitoring system would provide valuable feedback to improve the quality of patient care., Objectives: The purpose of the present pilot study was to describe postoperative pain, medication use, health care utilization and health-related quality of life (HRQOL) immediately and four weeks after surgery; merge clinically captured data with Web-based follow-up data; and examine patients' willingness to complete Web-based health questionnaires., Methods: One hundred two consecutive surgical inpatients were approached for participation. Perioperative data were abstracted from the acute pain management service clinical database and linked to follow-up data captured four weeks postoperatively., Results: Follow-up questionnaires were completed by 88 participants. Clinical assessment data were successfully linked to Web-based follow-up data. Average pain intensity (3.7) four weeks following discharge fell just short of the acute pain management service active pain score of 3.9. At four weeks, all 88 participants reported significantly impaired HRQOL, 36 were still taking pain medications and 15 had visited an emergency room. Two-thirds of the participants had access to the Internet at home and approximately one-half were willing to complete on-line health questionnaires., Discussion: The study indicates that it is feasible to link clinical and research data, and shows a significant burden of pain and reduced HRQOL in the weeks following discharge. This approach to converting clinically captured data into meaningful information about surgical outcomes is valuable in the development of an ongoing risk and outcomes monitoring system.

In accordance with the Montreal Protocol 1987, initiatives to phase out and replace ozone-depleting chlorofluorocarbon (CFC) propellants with non-ozone-depleting propellants in metered-dose inhalers (MDIs) in the treatment of asthma and chronic obstructive pulmonary disease are underway. In view of this, two multi-centre, randomised, parallel-group, double-blind studies were conducted to compare the safety and efficacy of salmeterol xinafoate delivered by an MDI using the hydrofluoroalkane (HFA) 134a propellant with the licensed CFC formulation (Serevent) in asthmatic populations of children (4-11 years) and adults (12 years). Patients on a stable dose of inhaled corticosteroids with a scope for improvement based on mean morning peak expiratory flow (PEF) and symptoms were randomised to receive salmeterol HFA MDI 50 microg twice daily or salmeterol CFC MDI 50 microg twice daily for 12 weeks. The primary efficacy variable was mean morning PEF and secondary variables included other lung function parameters, symptom scores, use of relief medication and safety assessments. The difference between the treatments in adjusted mean morning PEF (salmeterol HFA-salmeterol CFC) were 2.5 and -3.2 L/min for per-protocol populations of children and adults, respectively. The lower limit of 95% confidence intervals for both populations was within the pre-defined limit (-15 L/min) set for non-inferiority. Similar results were observed in intent-to-treat (ITT) populations. In children, the two formulations resulted in a lack of any statistically significant difference in secondary efficacy parameters. A significant difference at endpoint in clinic forced expiratory volume in 1s was reported in favour of the HFA formulation in the adult population, although the magnitude of this effect was not considered clinically significant. The incidences of adverse events (AEs) were similar for both formulations and populations, and no safety concerns were generated. Together these data demonstrate salmeterol HFA MDI to be as effective as salmeterol CFC MDI in adults and children.

Cancer arising at an ileostomy site represents a rare late complication of total colectomy performed for ulcerative colitis. There are no more than 36 published cases in the literature. We describe a case of adenocarcinoma of the mucocutaneous junction at the ileostomy site, occurring 31 years after total colectomy for ulcerative colitis. Wide excision of the moderately differentiated adenocarcinoma was performed with refashioning of the ileostomy. Polypoid adenomas or adenocarcinomas of the ileostomy after colectomy performed for non-neoplastic conditions are extremely uncommon. Biopsies of polypoid lesions at the stoma site are recommended.

This article considers the integral role played by patent law in respect of stem cell research. It highlights concerns about commercialization, access to essential medicines and bioethics. The article maintains that there is a fundamental ambiguity in the Patents Act 1990 (Cth) as to whether stem cell research is patentable subject matter. There is a need to revise the legislation in light of the establishment of the National Stem Cell Centre and the passing of the Research Involving Embryos Act 2002 (Cth). The article raises concerns about the strong patent protection secured by the Wisconsin Alumni Research Foundation and Geron Corporation in respect of stem cell research in the United States. It contends that a number of legal reforms could safeguard access to stem cell lines, and resulting drugs and therapies. Finally, this article explores how ethical concerns are addressed within the framework of the European Biotechnology Directive. It examines the decision of the European Patent Office in relation to the so-called "Edinburgh patent", and the inquiry of the European Group on Ethics in Science and New Technologies into "The Ethical Aspects of Patenting Involving Human Stem Cells".