Building Healthy Babies: A Mixed-Methods Needs Assessment for a Pre-Conception Program in Ontario.

OBJECTIVES: The objective of this study was to gather Ontario clinicians' and public members' views on the design of a pre-conception patient education program. METHODS: In this mixed-methods study, online surveys comprised of rank order, multiple choice, and short answer questions were completed by clinicians and public members. Semi-structured focus groups consisting of 2-6 participants each were then held via videoconference. Demographic variables and survey responses were analyzed quantitatively using descriptive and summary statistics. Descriptive thematic qualitative analysis using the constant comparative method of grounded theory was completed on each transcript to generate themes. RESULTS: A total of 168 public members and 43 clinicians in Ontario completed surveys, while 11 clinicians and 11 public members participated in the focus groups. A pre-conception program in Ontario was felt to be important. An individual appointment with a primary care provider was the favoured program format per survey responses, whereas a virtual format with an interactive component was preferred among focus group participants. Important topics to include were pre-conception health (infertility, genetic screening, folic acid), prenatal and postpartum counselling (diet, activity, substance use, prenatal care, postpartum course), and medical optimization in pregnancy (high-risk medical conditions, medications, mental health). Both groups emphasized the need to consider accommodations for marginalized populations and various cultures and languages. CONCLUSION: A standardized pre-conception patient education program is felt to be of high value by Ontario clinicians and public members. A pre-conception program may help improve obstetrical outcomes and decrease rates of major congenital anomalies in Ontario.

Patients' and providers' perspectives on the decision to undergo non-urgent egg freezing: a needs assessment.

BACKGROUND: Previous research has demonstrated that patients have difficulty with the decision to undergo non-urgent egg freezing (EF). This study aimed to investigate the decisional difficulties and possible decisional support mechanisms for patients considering EF, and for their providers. METHODS: This qualitative study involved a needs assessment via individual interviews. Participants included patients considering EF at one academic fertility clinic and providers from across Canada who counsel patients considering EF. 25 participants were included (13 providers and 12 patients). The interview guide was developed according to the Ottawa Decision Support Framework. Interviews were transcribed, and transcripts analyzed for themes and concepts using NVIVO 12. FINDINGS: Multiple factors contributing to decisional difficulty were identified, including: (1) multiple reproductive options available with differing views from patients/providers regarding their importance; (2) a decision typically made under the pressure of reproductive aging; (3) uncertainty surrounding the technology/inadequate outcome data; (4) the financial burden of EF; (5) inherent uncertainty relating to potential decision regret; and (6) differing perceptions between patients/providers regarding the role providers should play in the decision. Additionally, potential sources of decisional support were identified, including provision of basic information before and/or during initial consultation, followed by an opportunity during or after initial consultation for clarifying information and helping with value judgements. Individualized counselling based on patient values, adequate follow-up, psychosocial counselling, and peer support were also emphasized. CONCLUSIONS: More decisional support for women considering EF is needed. Suggestions include a patient decision aid in conjunction with modified healthcare provider counselling, support and follow up.

Set up and assessment of progression criteria for internal pilots: the Brushing RemInder 4 Good oral HealTh (BRIGHT) trial example.

BACKGROUND: Dental caries is common in young people and has wide-ranging ramifications for health and quality of life. Text messaging interventions show promise as a means to promote oral health behaviour change among young people. This paper reports the internal pilot of the Brushing RemInder 4 Good oral HealTh (BRIGHT) trial, which is evaluating an intervention comprising an oral health classroom lesson and text messages about toothbrushing, on caries in young people. Pilot trial objectives were to evaluate the feasibility and appropriateness of recruitment and data collection methods, the randomisation strategy, and intervention delivery against progression criteria for the main trial. METHODS: This is an internal pilot trial embedded within an assessor-blinded, two-arm, cluster randomised controlled trial. Participants were pupils aged 11-13 years (in year 7/S1 or year 8/S2) in secondary schools in England, Scotland, and Wales with above average pupil eligibility for free school meals. Following completion of pupil baseline questionnaires and dental assessments, year groups within schools were randomised to the intervention or control arm. Approximately 12 weeks later, participants completed a follow-up questionnaire, which included questions about sources of oral health advice to assess intervention contamination between year groups. At the end of the pilot phase, trial conduct was reviewed against pre-specified progression criteria. RESULTS: Ten schools were recruited for the pilot, with 20 year groups and 1073 pupils randomised (average of 54 pupils per year group). Data collection methods and intervention delivery were considered feasible, the response rate to the follow-up questionnaire was over 80%, there was an indication of a positive effect on self-reported toothbrushing, and interest was obtained from 80% of the schools required for the main trial. Despite partial intervention contamination between year groups, within-school randomisation at the level of the year-group was considered appropriate for the main trial, and the sample size was revised to account for partial contamination. Facilitators and barriers to recruitment and data collection were identified and strategies refined for the main trial. CONCLUSIONS: Progression to the main trial of BRIGHT, with some design refinements, was concluded. The internal pilot was an efficient way to determine trial feasibility and optimise trial processes. TRIAL REGISTRATION: ISRCTN registry, ISRCTN12139369 , registered 10/05/2017.

UpToDate versus DynaMed: a cross-sectional study comparing the speed and accuracy of two point-of-care information tools.

OBJECTIVE: To compare the accuracy, time to answer, user confidence, and user satisfaction between UpToDate and DynaMed (formerly DynaMed Plus), which are two popular point-of-care information tools. METHODS: A crossover study was conducted with medical residents in obstetrics and gynecology and family medicine at the University of Toronto in order to compare the speed and accuracy with which they retrieved answers to clinical questions using UpToDate and DynaMed. Experiments took place between February 2017 and December 2019. Following a short tutorial on how to use each tool and completion of a background survey, participants attempted to find answers to two clinical questions in each tool. Time to answer each question, the chosen answer, confidence score, and satisfaction score were recorded for each clinical question. RESULTS: A total of 57 residents took part in the experiment, including 32 from family medicine and 25 from obstetrics and gynecology. Accuracy in clinical answers was equal between UpToDate (average 1.35 out of 2) and DynaMed (average 1.36 out of 2). However, time to answer was 2.5 minutes faster in UpToDate compared to DynaMed. Participants were also more confident and satisfied with their answers in UpToDate compared to DynaMed. CONCLUSIONS: Despite a preference for UpToDate and a higher confidence in responses, the accuracy of clinical answers in UpToDate was equal to those in DynaMed. Previous exposure to UpToDate likely played a major role in participants' preferences. More research in this area is recommended.

Reinforcing locally led solutions for universal health coverage: a logic model with applications in Benin, Namibia and Uganda.

Development assistance for health programmes is often characterised as donor-led models with minimal country ownership and limited sustainability. This article presents new ways for low-income and middle-income countries to gain more control of their development assistance programming as they move towards universal health coverage (UHC). We base our findings on the experience of the African Collaborative for Health Financing Solutions (ACS), an innovative US Agency for International Development-funded project. The ACS project stems from the premise that the global health community can more effectively support UHC processes in countries if development partners change three long-standing paradigms: (1) time-limited projects to enhancing long-lasting processes, (2) fly-in/fly-out development support to leveraging and strengthening local and regional expertise and (3) static knowledge creation to supporting practical and co-developed resources that enhance learning and capture implementation experience. We assume that development partners can facilitate progress towards UHC if interventions follow five action steps, including (1) align to country demand, (2) provide evidence-based and tailored health financing technical support, (3) respond to knowledge and learnings throughout activity design and implementation, (4) foster multi-stakeholder collaboration and ownership and (5) strengthen accountability mechanisms. Since 2017, the ACS project has applied these five action steps in its implementing countries, including Benin, Namibia and Uganda. This article shares with the global health community preliminary achievements of implementing a unique, challenging but promising experience.

Major obstetric haemorrhage: Incidence, management and quality of care in Irish maternity units.

OBJECTIVE: To assess major obstetric haemorrhage incidence, management and quality of care in Irish maternity units. DESIGN: In collaboration with Irish maternity units the National Perinatal Epidemiology Centre (Leitao et al., 2020) carried out a national clinical audit and surveillance of major obstetric haemorrhage (MOH). METHODS: MOH was defined as blood loss of at least 2500 ml, transfusion of five or more units of blood or documented treatment for coagulopathy. Co-ordinators in maternity units completed detailed case assessment forms. The denominator data obtained from the individual units was restricted to live births and stillbirths of babies weighing at least 500 g. International Classification of Diseases diagnostic codes from hospital discharge records were used to identify cases of postpartum haemorrhage (PPH) and blood transfusion. RESULTS: During the time period, 2011-2018, there was a 54 % increase in MOH, a 60 % increase in PPH and a 54 % increase in blood transfusion. For 497 reported cases of MOH in 2011-2013, the median estimated blood loss was 3000 ml (range: 600-13,000 ml) and uterine atony was the most common cause. At least one uterotonic agent was used to arrest the bleeding in 94 % of the 477 MOH cases associated with a vaginal or caesarean delivery. A blood transfusion was received in 93 % of cases. Regarding quality of care, the vast majority of reported cases were described as receiving appropriate care and were well managed. CONCLUSION: Internationally, obstetric haemorrhage and especially PPH and its increasing trend remains a major challenge for service providers and clinical staff. A standardisation of definitions of PPH/severe PPH/MOH and agreed approaches to quantitation of blood loss would be valuable developments to allow better investigation and shared learning. Reducing the burden of this morbidity through improvements in care should be a real focus of maternity services.

A Community Development Program and Reduction in High-Cost Health Care Use.

Adverse housing and neighborhood conditions influence child health. The Healthy Neighborhoods Healthy Families community development initiative was established in 2008 to address housing, education, employment, and other neighborhood-level, child health-influencing factors on the south side of Columbus, Ohio, with the goal of improving child health and well-being. In this article, we discuss the path from advocacy to outcomes analysis in this initiative and assess changes in high-cost health care use by children in the target area over the first decade of implementation. Change in health care use was measured by using a difference-in-differences approach comparing emergency department visits, inpatient stays, and inpatient length of stay in the intervention neighborhood and a propensity score-matched, pooled comparator neighborhood in the same city. The baseline and follow-up periods were August 2008 to July 2010 and August 2015 to July 2017, respectively. Findings from this analysis reveal that compared to 2 pooled comparison neighborhoods, the intervention neighborhood trended, nonsignificantly, toward greater decreases in inpatient stays and emergency department visits and smaller increases in length of stays. These results suggest that our community development activities may be influencing health care use outcomes, but in the early years of the intervention relative changes are modest and are variable based on the definition of the intervention and comparator neighborhoods. Lessons learned in expanding from advocacy to analysis include the importance of building multidisciplinary teams that can apply novel approaches to analysis, moderating expectations, and retaining focus on the broader social context.

Brushing RemInder 4 Good oral HealTh (BRIGHT) trial: does an SMS behaviour change programme with a classroom-based session improve the oral health of young people living in deprived areas? A study protocol of a randomised controlled trial.

BACKGROUND: Almost one-half of 12-15 year olds living in deprived areas of the UK have dental caries (tooth decay) with few oral health promotion programmes aimed at children of this age. Mobile phone-based interventions such as short messaging service (SMS) interventions have been found effective at changing certain behaviours and improving health outcomes. This protocol describes the BRIGHT Trial, investigating the clinical and cost-effectiveness of a behaviour change intervention-classroom-based session (CBS) embedded in the curriculum and a series of SMS delivered to participants twice daily to remind them to brush their teeth, compared to usual curriculum and no SMS-to reduce the prevalence of dental caries in young people from deprived areas. OBJECTIVES: To investigate the clinical and cost-effectiveness of a complex intervention to improve the oral health of young people living in deprived areas. METHODS/DESIGN: This is a school-based, assessor-blinded, two-arm cluster-randomised controlled trial with an internal pilot trial. Overall, the trial will involve approximately 5040 11-13 year olds in 42 schools with a 3-year follow-up. The trial will take place in secondary schools in England, Scotland and Wales. The primary outcome is the presence of carious lesions in permanent teeth at 3 years. Secondary outcomes are: number of carious teeth, frequency of twice-daily toothbrushing, plaque levels, gingivitis, child health-related quality of life and oral health-related quality of life. A cost-utility analysis will be conducted. DISCUSSION: The findings of the trial have implications for embedding oral health interventions into school curricula guidance produced by national bodies, including departments for education and dental public health and guideline-development organisations. TRIAL REGISTRATION: ISRCTN registry, ISRCTN12139369 . Registered on 10 May 2017.

Assessment of an Antibody-in-Lymphocyte Supernatant Assay for the Etiological Diagnosis of Pneumococcal Pneumonia in Children.

New diagnostic tests for the etiology of childhood pneumonia are needed. We evaluated the antibody-in-lymphocyte supernatant (ALS) assay to detect immunoglobulin (Ig) G secretion from ex vivo peripheral blood mononuclear cell (PBMC) culture, as a potential diagnostic test for pneumococcal pneumonia. We enrolled 348 children with pneumonia admitted to Patan Hospital, Kathmandu, Nepal between December 2015 and September 2016. PBMCs sampled from participants were incubated for 48 h before harvesting of cell culture supernatant (ALS). We used a fluorescence-based multiplexed immunoassay to measure the concentration of IgG in ALS against five conserved pneumococcal protein antigens. Of children with pneumonia, 68 had a confirmed etiological diagnosis: 12 children had pneumococcal pneumonia (defined as blood or pleural fluid culture-confirmed; or plasma CRP concentration ≥60 mg/l and nasopharyngeal carriage of serotype 1 pneumococci), and 56 children had non-pneumococcal pneumonia. Children with non-pneumococcal pneumonia had either a bacterial pathogen isolated from blood (six children); or C-reactive protein <60 mg/l, absence of radiographic consolidation and detection of a pathogenic virus by multiplex PCR (respiratory syncytial virus, influenza viruses, or parainfluenza viruses; 23 children). Concentrations of ALS IgG to all five pneumococcal proteins were significantly higher in children with pneumococcal pneumonia than in children with non-pneumococcal pneumonia. The concentration of IgG in ALS to the best-performing antigen discriminated between children with pneumococcal and non-pneumococcal pneumonia with a sensitivity of 1.0 (95% CI 0.73-1.0), specificity of 0.66 (95% CI 0.52-0.78) and area under the receiver-operating characteristic curve (AUROCC) 0.85 (95% CI 0.75-0.94). Children with pneumococcal pneumonia were older than children with non-pneumococcal pneumonia (median 5.6 and 2.0 years, respectively, p < 0.001). When the analysis was limited to children ≥2 years of age, assay of IgG ALS to pneumococcal proteins was unable to discriminate between children with pneumococcal pneumonia and non-pneumococcal pneumonia (AUROCC 0.67, 95% CI 0.47-0.88). This method detected spontaneous secretion of IgG to pneumococcal protein antigens from cultured PBMCs. However, when stratified by age group, assay of IgG in ALS to pneumococcal proteins showed limited utility as a test to discriminate between pneumococcal and non-pneumococcal pneumonia in children.

Assessment and Translation of the Antibody-in-Lymphocyte Supernatant (ALS) Assay to Improve the Diagnosis of Enteric Fever in Two Controlled Human Infection Models and an Endemic Area of Nepal.

New diagnostic tests for enteric fever are urgently needed to assist with timely antimicrobial treatment of patients and to measure the efficacy of prevention measures such as vaccination. In a novel translational approach, here we use two recently developed controlled human infection models (CHIM) of enteric fever to evaluate an antibody-in-lymphocyte supernatant (ALS) assay, which can detect recent IgA antibody production by circulating B cells in ex vivo mononuclear cell culture. We calculated the discriminative ability of the ALS assay to distinguish diagnosed cases in the two CHIM studies in Oxford, prior to evaluating blood culture-confirmed diagnoses of patients presenting with fever to hospital in an endemic areas of Kathmandu, Nepal. Antibody responses to membrane preparations and lipopolysaccharide provided good sensitivity (>90%) for diagnosing systemic infection after oral challenge with Salmonella Typhi or S. Paratyphi A. Assay specificity was moderate (~60%) due to imperfect sensitivity of blood culture as the reference standard and likely unrecognized subclinical infection. These findings were augmented through the translation of the assay into the endemic setting in Nepal. Anti-MP IgA responses again exhibited good sensitivity (86%) but poor specificity (51%) for detecting blood culture-confirmed enteric fever cases (ROC AUC 0.79, 95%CI 0.70-0.88). Patients with anti-MP IgA ALS titers in the upper quartile exhibited a clinical syndrome synonymous with enteric fever. While better reference standards are need to assess enteric fever diagnostics, routine use of this ALS assay could be used to rule out infection and has the potential to double the laboratory detection rate of enteric fever in this setting over blood culture alone.

Modifying Alcohol Consumption to Reduce Obesity: A Randomized Controlled Feasibility Study of a Complex Community-based Intervention for Men.

OBJECTIVES: Being obese and drinking more than 14 units of alcohol per week places men at very high risk of developing liver disease. This study assessed the feasibility of a trial to reduce alcohol consumption. It tested the recruitment strategy, engagement with the intervention, retention and study acceptability. METHODS: Men aged 35-64 years who drank >21 units of alcohol per week and had a BMI > 30 were recruited by two methods: from GP patient registers and by community outreach. The intervention was delivered by a face to face session followed by a series of text messages. Trained lay people (Study Coordinators) delivered the face to face session. Participants were followed up for 5 months from baseline to measure weekly alcohol consumption and BMI. RESULTS: The recruitment target of 60 was exceeded, with 69 men recruited and randomized. At baseline, almost all the participants (95%) exceeded the threshold for a 19-fold increase in the risk of dying from liver disease. The intervention was delivered with high fidelity. A very high follow-up rate was achieved (98%) and the outcomes for the full trial were measured. Process evaluation showed that participants responded as intended to key steps in the behaviour change strategy. The acceptability of the study methods was high: e.g. 80% of men would recommend the study to others. CONCLUSIONS: This feasibility study identified a group at high risk of liver disease. It showed that a full trial could be conducted to test the effectiveness and cost-effectiveness of the intervention. TRIAL REGISTRATION: Current controlled trials: ISRCTN55309164. TRIAL FUNDING: National Institute for Health Research Health Technology Assessment (NIHR HTA). SHORT SUMMARY: This feasibility study recruited 69 men at high risk of developing liver disease. The novel intervention, to reduce alcohol consumption through the motivation of weight loss, was well received. A very high follow-up rate was achieved. Process evaluation showed that participants engaged with key components of the behaviour change strategy.

Modifying Alcohol Consumption to Reduce Obesity (MACRO): development and feasibility trial of a complex community-based intervention for men.

BACKGROUND: Obese men who consume alcohol are at a greatly increased risk of liver disease; those who drink > 14 units of alcohol per week have a 19-fold increased risk of dying from liver disease. OBJECTIVES: To develop an intervention to reduce alcohol consumption in obese men and to assess the feasibility of a randomised controlled trial (RCT) to investigate its effectiveness. DESIGN OF THE INTERVENTION: The intervention was developed using formative research, public involvement and behaviour change theory. It was organised in two phases, comprising a face-to-face session with trained laypeople (study co-ordinators) followed by a series of text messages. Participants explored how alcohol consumption contributed to weight gain, both through direct calorie consumption and through its effect on increasing food consumption, particularly of high-calorie foodstuffs. Men were encouraged to set goals to reduce their alcohol consumption and to make specific plans to do so. The comparator group received an active control in the form of a conventional alcohol brief intervention. Randomisation was carried out using the secure remote web-based system provided by the Tayside Clinical Trials Unit. Randomisation was stratified by the recruitment method and restricted using block sizes of randomly varying lengths. Members of the public were involved in the development of all study methods. SETTING: Men were recruited from the community, from primary care registers and by time-space sampling (TSS). The intervention was delivered in community settings such as the participant's home, community centres and libraries. PARTICIPANTS: Men aged 35-64 years who had a body mass index (BMI) of > 30 kg/m2 and who drank > 21 units of alcohol per week. RESULTS: The screening methods successfully identified participants meeting the entry criteria. Trial recruitment was successful, with 69 men (36 from 419 approached in primary care, and 33 from 470 approached via TSS) recruited and randomised in 3 months. Of the 69 men randomised, 35 were allocated to the intervention group and 34 to the control group. The analysis was conducted on 31 participants from the intervention group and 30 from the control group. The participants covered a wide range of ages and socioeconomic statuses. The average alcohol consumption of the men recruited was 47.2 units per week, more than twice that of the entry criterion (> 21 units per week). Most (78%) engaged in binge drinking (> 8 units in a session) at least weekly. Almost all (95%) exceeded the threshold for a 19-fold increase in the risk of dying from liver disease (BMI of > 30 kg/m2 and > 14 units of alcohol per week). Despite this, they believed that they were at low risk of harm from alcohol, possibly because they seldom suffered acute harms (e.g. hangovers) and made few visits to a general practitioner or hospital. INTERVENTION: The intervention was delivered with high fidelity. A high follow-up rate was achieved (98%) and the outcomes for the full RCT were measured. A process evaluation showed that participants engaged with the main components of the intervention. The acceptability of the study methods was high. CONCLUSIONS: This feasibility study developed a novel intervention and evaluated all of the stages of a RCT that would test the effectiveness of the intervention. The main stages of a trial were completed successfully: recruitment, randomisation, intervention delivery, follow-up and measurement of study outcomes. Most of the men recruited drank very heavily and were also obese. This places them at a very high risk of liver disease, making them a priority for intervention. FUTURE WORK: A RCT to test the effectiveness and cost-effectiveness of the intervention. TRIAL REGISTRATION: Current Controlled Trials ISRCTN55309164. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 21, No. 19. See the NIHR Journals Library website for further project information.

Prioritization of Patients for Publicly Funded IVF in Ontario: A Survey of Fertility Centres.

OBJECTIVE: On December 21, 2015, Ontario began funding one cycle of IVF for any Ontarian under age 43, with a program cap of 5000 cycles per year, which is below expected demand. Our objective was to determine how fertility clinics are prioritizing patients for limited-funded IVF cycles. METHODS: An electronic survey was emailed to medical directors of all 25 fertility clinics providing funded IVF in Ontario. RESULTS: From January to March 2016, 22 (88%) of the clinics responded. All reported providing access to funded IVF, and 100% already had a wait list. Eight clinics prioritized patients on a first-come, first-served basis; two used a lottery; 11 reported using multiple patient factors to determine priority for funding; and one declined to answer. Of the clinics reporting multiple factors, the five most common factors were first-come, first-served (90.9%); older aged patients (81.8%); patients about to lose their funding eligibility (63.6%); duration of infertility (36.3%); and duration at current clinic (36.3%). CONCLUSIONS: There is variation in how patients are prioritized for publicly funded IVF in Ontario. Some clinics have chosen to prioritize patients in a first-come, first-served manner, whereas others have chosen to prioritize patients based on multiple factors that would favour older patients. This is the first study providing the public and government insight on how the new fertility program has been implemented by individual clinics. This information is important for patients to understand their own chances of receiving a funded IVF cycle because this may vary depending on individual clinics.

A barrier to medical treatment? British medical practitioners, medical appliances and the patent controversy, 1870-1920.

From the late nineteenth century onwards there emerged an increasingly diverse response to escalating patenting activity. Inventors were generally supportive of legislation that made patenting more accessible, while others, especially manufacturers, saw patenting culture as an impediment. The medical profession claimed that patenting represented 'a barrier to medical treatment' and was thus detrimental to the nation's health, yet, as I argue, the profession's development of strict codes of conduct forbidding practitioners from patenting resulted in rebellion from some members, who increasingly sought protection for their inventions. Such polarized opinions within the medical trade continue to affect current medical practice today.

A mobile phone intervention to reduce binge drinking among disadvantaged men: study protocol for a randomised controlled cost-effectiveness trial.

BACKGROUND: Socially disadvantaged men are at a substantially higher risk of developing alcohol-related problems. The frequency of heavy drinking in a single session is high among disadvantaged men. Brief alcohol interventions were developed for, and are usually delivered in, healthcare settings. The group who binge drink most frequently, young to middle-aged disadvantaged men, have less contact with health services and there is a need for an alternative method of intervention delivery. Text messaging has been used successfully to modify other adverse health behaviours. This study will test whether text messages can reduce the frequency of binge drinking by disadvantaged men. METHODS/DESIGN: Disadvantaged men aged 25 to 44 years who drank >8 units of alcohol at least twice in the preceding month will be recruited from the community. Two recruitment strategies will be used: contacting men listed in primary care registers, and a community outreach method (time-space sampling). The intended sample of 798 men will be randomised to intervention or control, stratifying by recruitment method. The intervention group will receive a series of text messages designed to reduce the frequency of binge drinking through the formation of specific action plans. The control group will receive behaviourally neutral text messages intended to promote retention in the study. The primary outcome measure is the proportion of men consuming >8 units on at least three occasions in the previous 30 days. Secondary outcomes include total alcohol consumption and the frequency of consuming more than 16 units of alcohol in one session in the previous month. Process measures, developed during a previous feasibility study, will monitor engagement with the key behaviour change components of the intervention. The study will incorporate an economic evaluation comparing the costs of recruitment and intervention delivery with the benefits of reduced alcohol-related harm. DISCUSSION: This study will assess the effectiveness of a brief intervention, delivered by text messages, aimed at reducing the frequency of binge drinking in disadvantaged men. The process measures will identify components of the intervention which contribute to effectiveness. The study will also determine whether any benefit of the intervention is justified by the costs of intervening. TRIAL REGISTRATION: ISRCTN07695192. Date assigned: 14 August 2013.

Bon voyage: an update on safe travel in pregnancy.

Travel in pregnancy is common, particularly as international travel for work and leisure has become more commonplace. Few women are fully aware of the potential risks of travelling while pregnant, particularly the risk of delivering abroad. We describe here the medical risks and the many social, financial, and logistical considerations for travelling during pregnancy. Pertinent considerations include the risks of developing medical complications abroad, immunization considerations, access to obstetrical care in developing countries, travel medical insurance, and airline regulations.

Les femmes enceintes sont fréquemment appelées à se déplacer, particulièrement depuis que les déplacements internationaux pour des raisons professionnelles et ludiques sont devenus plus courants. Peu de femmes connaissent vraiment les risques potentiels qui sont associés aux déplacements pendant la grossesse (et particulièrement le risque d'accoucher à l'étranger). Nous décrivons ici les risques médicaux et les nombreux facteurs sociaux, financiers et logistiques à prendre en considération pour ce qui est des déplacements pendant la grossesse. Parmi les facteurs pertinents à prendre en considération, on trouve le risque d'en venir à connaître des complications médicales à l'étranger, les immunisations requises, l'accès aux soins obstétricaux au sein des pays en développement, la couverture médicale assurée par l'assurance voyage et les règlements des transporteurs aériens.

Fertility treatment decision-making: the effect of insurance coverage for fertility medications.

OBJECTIVE: To analyze the perceived impact of insurance coverage for fertility medications on patients' fertility treatment decision-making. METHODS: We conducted a cross-sectional study involving a patient survey and chart review of women at a Canadian university-affiliated fertility centre. The primary outcome was to determine whether women with self-reported insurance coverage for fertility medications perceived the impact of insurance coverage for fertility medications differently from women without coverage or those who do not know their extent of coverage. Secondary outcomes included differences between groups in the perceived impact of insurance coverage for fertility medications on specific treatment decisions and the type of fertility treatments undergone by patients. Data collected from the survey and chart review were analyzed using chi-square tests. RESULTS: More women without insurance ranked insurance coverage as having a large impact on the decision to undergo fertility treatment than women in the other groups, although this was not statistically significant. Significantly more women without insurance coverage ranked all specific treatment decisions except for the number of IVF cycles as having a large impact than did women in the other groups. CONCLUSION: Women perceive that having insurance coverage for fertility medications affects the decision to undergo fertility treatment. Women without insurance are more likely to perceive that insurance coverage affects specific fertility treatment decisions than women with insurance or women who do not know whether they have insurance.

E-mail invitations to general practitioners were as effective as postal invitations and were more efficient.

OBJECTIVE: To evaluate which of two invitation methods, e-mail or post, was most effective at recruiting general practitioners (GPs) to an online trial. STUDY DESIGN AND SETTING: Randomized controlled trial. Participants were GPs in Scotland, United Kingdom. RESULTS: Two hundred and seventy GPs were recruited. Using e-mail did not improve recruitment (risk difference=0.7% [95% confidence interval -2.7% to 4.1%]). E-mail was, however, simpler to use and cheaper, costing £3.20 per recruit compared with £15.69 for postal invitations. Reminders increased recruitment by around 4% for each reminder sent for both invitation methods. CONCLUSIONS: In the Scottish context, inviting GPs to take part in an online trial by e-mail does not adversely affect recruitment and is logistically easier and cheaper than using postal invitations.

The true cost of gallstone disease.

INTRODUCTION: Gallstone related disease accounts for a large expenditure in the NHS. The aim of this study was to review the events and costs of the patient journey to treatment, and propose guidelines to provide an efficient streamlined service. PATIENTS AND METHODS: All cholecystectomies performed in one unit in 2009 were reviewed. The cost of all investigations and procedures performed was obtained from the Department of Health website. The individual cost was calculated for each patient. Results were expressed as mean (±SD) and compared using ANOVA. RESULTS: 132 patients (31 male) were reviewed with an overall age was 45.3 years (±15.1). Overall cost from referral to discharge was £4697 (±2007) per patient, ranging from £3406 to £12011. The largest proportion was contributed by surgery at £2849 (±414), followed by inpatient costs at £1527 (±1322). Pre-operative outpatient consultations were £174 (±144), supplemented by at least one ultrasound (£81±29). Additional imaging was required for only a minority. All blood tests involved in overall care contributed little to the total at £27 (±26). Patients who initially presented as an inpatient had an overall larger cost (£6112±1888 vs. £5097±1607; p=0.004). This difference was largely due to inpatient costs (£2611±1629 vs. £1194±1009; p<0.0001) and not the cost of surgery (p=0.29). Patients who were imaged in primary care prior to referral also had a lower overall cost (£4636±1343 vs. £5697±1804; p=0.0005). This was also due to inpatient costs (£1076±876 vs. £1740±1459; p=0.004) and not the actual surgery costs (p=0.36). Only 39 were reviewed post-operatively, adding £38±69 to the overall cohort costs. CONCLUSION: Emergency presentation and repeat admissions result in higher inpatient costs and should be avoided. Reduced delay to elective surgery through active participation by primary care needs to be encouraged.