Disappearing colorectal liver metastases in the era of state-of-the-art triple-modality diagnostic imaging.

INTRODUCTION: Systemic therapy can result in disappearance of colorectal liver metastases in up to 40% of patients. This might be an overestimation caused by suboptimal imaging modalities. The aim of this study was to investigate the use of imaging modalities and the incidence, management and outcome of patients with disappearing liver metastases (DLMs). METHODS: This was a retrospective study of consecutive patients treated for colorectal liver metastases at a high volume hepatobiliary centre between January 2013 and January 2015 after receiving induction or neoadjuvant systemic therapy. Main outcomes were use of imaging modalities, incidence, management and longterm outcome of patients with DLMs. RESULTS: Of 158 patients included, 32 (20%) had 110 DLMs. Most patients (88%) had initial diagnostic imaging with contrast enhanced-CT, primovist-MR and FDG-PET and 94% of patients with DLMs were restaged using primovist-MR. Patients with DLMs had significantly smaller metastases and the median initial size of DLMs was 10 mm (range 5-61). In the per lesion analysis, recurrence after "watch & wait" for DLMs occurred in 36%, while in 19 of 20 resected DLMs no viable tumour cells were found. Median overall (51 vs. 28 months, p < 0.05) and progression free survival (10 vs. 3 months, p = 0.003) were significantly longer for patients with DLMs. CONCLUSION: Even state-of-the-art imaging and restaging cannot solve problems associated with DLMs. Regrowth of these lesions occurs in approximately a third of the lesions. Patients with DLMs have better survival.

The Recognition of Excessive blood loss At ChildbirTh (REACT) Study: a two-phase exploratory, sequential mixed methods inquiry using focus groups, interviews and a pilot, randomised crossover study.

OBJECTIVES: To explore how childbirth-related blood loss is evaluated and excessive bleeding recognised; and to develop and test a theory of postpartum haemorrhage (PPH) diagnosis. DESIGN: Two-phase, exploratory, sequential mixed methods design using focus groups, interviews and a pilot, randomised crossover study. SETTING: Two hospitals in North West England. SAMPLE: Women (following vaginal birth with and without PPH), birth partners, midwives and obstetricians. METHODS: Phase 1 (qualitative): 8 focus groups and 20 one-to-one, semi-structured interviews were conducted with 15 women, 5 birth partners, 11 obstetricians, 1 obstetric anaesthetist and 19 midwives (n = 51). Phase 2 (quantitative): 11 obstetricians and ten midwives (n = 21) completed two simulations of fast and slow blood loss using a high-fidelity childbirth simulator. RESULTS: Responses to blood loss were described as automatic, intuitive reactions to the speed, nature and visibility of blood flow. Health professionals reported that quantifying volume was most useful after a PPH diagnosis, to validate intuitive decisions and guide ongoing management. During simulations, PPH treatment was initiated at volumes at or below 200 ml (fast mean blood loss 79.6 ml, SD 41.1; slow mean blood loss 62.6 ml, SD 27.7). All participants treated fast, visible blood loss, but only half treated slow blood loss, despite there being no difference in volumes (difference 18.2 ml, 95% CI -5.6 to 42.2 ml, P = 0.124). CONCLUSIONS: Experience and intuition, rather than blood loss volume, inform recognition of excessive blood loss after birth. Women and birth partners want more information and open communication about blood loss. Further research exploring clinical decision-making and how to support it is required. TWEETABLE ABSTRACT: During a PPH, clinical decision-making is intuitive with clinicians treating as soon as excessive loss is recognised.

Why are women still dying from obstetric hemorrhage? A narrative review of perspectives from high and low resource settings.

The possibility of hemorrhage will always co-exist with pregnancy, whether anticipated or not. It remains the unwelcome guest in the corner of every delivery room, stealing the lives of young women every day across the globe. In 2014, the World Health Organization reported that hemorrhage was the leading contributor to maternal mortality worldwide, with nearly 75% of maternal deaths due to postpartum hemorrhage. In low resource settings, while maternal mortality is decreasing, hemorrhage remains the single most important contributor to maternal death. Hospital-based deliveries with skilled birth attendants have been encouraged to improve outcomes and, as a result, hospital births have dramatically increased. However, access to higher levels of emergency obstetric care as well as blood products and therapeutic resources remain limiting factors. Meanwhile, in high resource settings, maternal mortality from hemorrhage is increasing, particularly among women of color. While very rare, mortality from hemorrhage generally follows medical interventions such as surgical management of placenta accreta or emergency cesarean section. Primary prevention therefore requires careful selection and conduct of medical interventions, as well as the provision of high quality, supportive, and safe maternity care. It is clear that there is not one single solution in preventing obstetric hemorrhage on a global scale. The international community must employ creative solutions to reduce this ever-present problem.

Foley catheter vs oral misoprostol for induction of labor: individual participant data meta-analysis.

OBJECTIVE: To compare the effectiveness and safety of Foley catheter and oral misoprostol for induction of labor (IOL). METHODS: The Cochrane Review on Mechanical Methods for Induction of Labour and Ovid MEDLINE, EMBASE via Ovid, Ovid Emcare, CINAHL Plus, ClinicalTrials.gov and Scopus, from inception to April 2019, were searched for randomized controlled trials (RCTs) comparing Foley catheter to oral misoprostol for IOL in viable singleton gestations. Eligible trials for which raw data were obtained were included and individual participant data meta-analysis was performed. Primary outcomes were vaginal birth, a composite of adverse perinatal outcome (including stillbirth, neonatal death, neonatal seizures, admission to the neonatal intensive care unit, severe respiratory compromise or meconium aspiration syndrome) and a composite of adverse maternal outcome (including admission to the intensive care unit, maternal infection, severe postpartum hemorrhage, maternal death or uterine rupture). The quality of the included RCTs was assessed using the Cochrane Risk of Bias 2 tool and the certainty of evidence was evaluated using the GRADE approach. A two-stage random-effects model was used for meta-analysis according to the intention-to-treat principle and interactions between treatment and baseline characteristics were assessed. RESULTS: Of seven eligible trials, four provided individual participant data for a total of 2815 participants undergoing IOL, of whom 1399 were assigned to Foley catheter and 1416 to oral misoprostol. All four trials provided data for each of the primary outcomes in all 2815 women. Compared with those receiving oral misoprostol, Foley catheter recipients had a slightly decreased chance of vaginal birth (risk ratio (RR), 0.95 (95% CI, 0.91-0.99); I2 , 2.0%; moderate-certainty evidence). A trend towards a lower rate of composite adverse perinatal outcome was found in women undergoing IOL using a Foley catheter compared with oral misoprostol (RR, 0.71 (95% CI, 0.48-1.05); I2 , 14.9%; low-certainty evidence). Composite adverse maternal outcome did not differ between the groups (RR, 1.00 (95% CI, 0.97-1.03); I2 , 0%; moderate-certainty evidence). Meta-analyses of effect modifications did not show significant interactions between intervention and parity or gestational age for any of the primary outcomes. CONCLUSIONS: For women undergoing IOL, Foley catheter is less effective than oral misoprostol, as it was associated with fewer vaginal births. However, while we found no significant difference in maternal safety, Foley catheter induction may reduce adverse perinatal outcomes. Copyright © 2020 ISUOG. Published by John Wiley & Sons Ltd.

STRAWB2 (Stress and Wellbeing After Childbirth): a randomised controlled trial of targeted self-help materials to prevent post-traumatic stress disorder following childbirth.

OBJECTIVES: To test whether providing psychological self-help materials would significantly lower the incidence of post-traumatic stress disorder (PTSD) at 6-12 weeks postnatally. DESIGN: Open-label randomised controlled trial, with blinded outcome assessment. SETTING: Community midwifery services in two National Health Service (NHS) trusts in the North West. SAMPLE: A cohort of 2419 women receiving normal NHS postnatal care. METHODS: Midwives screened women for traumatic birth experience; 678 women who screened positively (28.1%) were randomly allocated to self-help with usual care (n = 336) or to usual care alone (n = 342). The self-help materials were a leaflet and online film designed to prevent the development of PTSD after trauma exposure through explaining how to manage early psychological responses. MAIN OUTCOME MEASURE: The primary outcome was a composite of diagnostic and subdiagnostic PTSD at 6-12 weeks postnatally using the gold-standard Clinician-Administered PTSD Scale (CAPS-5) interview. RESULTS: Of the 678 women correctly randomised plus the nine women randomised in error, 478 (70.5%) were followed up. Diagnostic or subdiagnostic PTSD rates at follow-up did not differ between groups who received self-help (26.7%, 65/243) or usual care alone (26.2%, 64/244) (intention-to-treat analysis: RR 1.02, 95% CI 0.68-1.53). Findings remained consistent in the per-protocol analysis (RR 1.04, 95% CI 0.85-1.27). Women viewed the materials very positively. There were no adverse effects. Health economic micro-costing indicated implementation would be very low cost. CONCLUSIONS: Many women experience a traumatic birth and risk developing PTSD, but self-help strategies without professional support are insufficient and should not be routinely introduced. TWEETABLE ABSTRACT: Self-help information alone does not reduce the number of women developing PTSD after a traumatic childbirth.

Work-related post-traumatic stress symptoms in obstetricians and gynaecologists: findings from INDIGO, a mixed-methods study with a cross-sectional survey and in-depth interviews.

OBJECTIVES: To explore obstetricians' and gynaecologists' experiences of work-related traumatic events, to measure the prevalence and predictors of post-traumatic stress disorder (PTSD), any impacts on personal and professional lives, and any support needs. DESIGN: Mixed methods: cross-sectional survey and in-depth interviews. SAMPLE AND SETTING: Fellows, members and trainees of the Royal College of Obstetricians and Gynaecologists (RCOG). METHODS: A survey was sent to 6300 fellows, members and trainees of RCOG. 1095 people responded. Then 43 in-depth interviews with trauma-exposed participants were completed and analysed by template analysis. MAIN OUTCOME MEASURES: Exposure to traumatic work-related events and PTSD, personal and professional impacts, and whether there was any need for support. Interviews explored the impact of trauma, what helped or hindered psychological recovery, and any assistance wanted. RESULTS: Two-thirds reported exposure to traumatic work-related events. Of these, 18% of both consultants and trainees reported clinically significant PTSD symptoms. Staff of black or minority ethnicity were at increased risk of PTSD. Clinically significant PTSD symptoms were associated with lower job satisfaction, emotional exhaustion and depersonalisation. Organisational impacts included sick leave, and 'seriously considering leaving the profession'. 91% wanted a system of care. The culture in obstetrics and gynaecology was identified as a barrier to trauma support. A strategy to manage the impact of work-place trauma is proposed. CONCLUSIONS: Exposure to work-related trauma is a feature of the experience of obstetricians and gynaecologists. Some will suffer PTSD with high personal, professional and organisational impacts. A system of care is needed. TWEETABLE ABSTRACT: 18% of obstetrics and gynaecology doctors experience post-traumatic stress disorder after traumatic events at work.

Newly diagnosed cases of HIV in those aged 50 years and older and those less than 50: 2008-2017.

BACKGROUND: Canada's population is aging, with nearly forty percent of Canadians aged 50 years or more. As the population ages, unique challenges related to health are becoming evident, including increasing rates of sexually transmitted and bloodborne infections. Understanding the epidemiology of HIV in older adults is important to guide prevention and control programs. OBJECTIVE: To assess trends in newly diagnosed cases of HIV in Canada among those aged 50 years and older (≥50 years) and those aged less than 50 (<50 years), and to compare their basic demographic characteristics and exposure categories for the period of 2008 to 2017. METHODS: National surveillance of HIV is conducted by the Public Health Agency of Canada through voluntary submission of data by provincial/territorial public health authorities. Descriptive analyses were conducted on reported cases of HIV between January 1, 2008, to December 31, 2017 to compare the demographic profiles and exposure category for the two age groups. RESULTS: Between 2008 and 2017, the proportion of newly diagnosed HIV cases among those ≥50 years increased from 15.1% to 22.8%. The HIV diagnosis rates for both older males and older females increased over time, with a relatively higher increase for females. A higher proportion of newly diagnosed HIV cases were male in the older group (81.2%) compared to the younger group (74.6%). Among both older and younger males, the most common exposure category for HIV was being gay, bisexual and other men who have sex with men (gbMSM), followed by heterosexual contact and injection drug use; however, the relative proportions varied by age with the gbMSM category being higher in the <50 group. CONCLUSION: In Canada, over 20% of all newly diagnosed cases of HIV are now in people 50 years of age and older. HIV testing and prevention initiatives, historically aimed at younger populations, may not have the same impact for older populations. These data can be used to inform future public health actions designed to address HIV in older populations.

BabyGel pilot: a pilot cluster randomised trial of the provision of alcohol handgel to postpartum mothers to prevent neonatal and young infant infection-related morbidity in the community.

BACKGROUND: Alcohol-based hand rub (ABHR) is widely used in both health and social facilities to prevent infection, but it is not known whether supplying it for regular perinatal use can prevent newborn sepsis in African rural homes. Our study piloted a cluster randomised trial of providing ABHR to postpartum mothers to prevent neonatal infection-related morbidity in the communities. METHODS: We conducted a pilot parallel cluster randomised controlled trial across ten villages (clusters) in rural Eastern Uganda. Pregnant women of over 34 weeks' gestation were recruited over a period of 3 months. Both clusters received the standard of care of antenatal health education, Maama Kit, and clinic appointments. In addition, women in the intervention villages received ABHR, instructions on ABHR use, a poster on the 'three moments of hand hygiene', and training. We followed up each mother-baby pair for 3 months after birth and measured rates of consent, recruitment, and follow-up (our target rate was more than 80%). Other measures included ABHR use (the acceptable use was more than four times a day) and its mode of distribution (village health workers (VHWs) or pharmacy), acceptability of study protocol and electronic data capture, and the use of WHO Integrated Management of Childhood Illness (IMCI) tool to screen for newborn infection. RESULTS: We selected 36% (10/28) of villages for randomisation to either intervention or control. Over 12 weeks, 176 pregnant women were screened and 58.5% (103/176) were eligible. All, 100% (103/103), eligible women gave consent and were enrolled into the trial (55 intervention and 48 control). After birth, 94.5% (52/55) of mothers in the intervention and 100% (48/48) of mothers in the control villages were followed up within 72 h. Most, 90.9% (50/55), of the mothers in the intervention villages (96.2% of live births) and 95.8% (46/48) of mothers in the control villages (95.9% of live births) were followed up at 3 months. In intervention villages, the average hand rub use was 6.6 times per day. VHWs accounted for all ABHR stock, compared to the pharmacy that could not account for 5 l of ABHR. The screening tool was positive for infection among a third of babies, i.e. 29.2% (14/48) in the intervention villages versus 31.4% (16/51) in the control villages.VHWs completed the first four questions of IMCI screening tool with ease and accuracy. There were no adverse reactions with the ABHR. CONCLUSION: It is feasible to conduct a cluster-randomised controlled trial (cRCT) of the provision of ABHR to postpartum mothers to prevent neonatal infection-related morbidity in the community in resource-poor settings. Our results indicate that home recruitment promotes excellent follow-up and retention of participants in community trials. The intervention was safe. This pilot study informed the substantial changes necessary in the larger cRCT, including a change in the primary outcome to a composite outcome considering multiple methods of infection detection. A large BabyGel cluster randomised controlled trial is now required. TRIAL REGISTRATION: ISRCTN67852437, registered March 02, 2015. TRIAL FUNDING: Medical Research Council/WellcomeTrust/DfID (Global Health Trials Scheme).

In search of a primary outcome for community-based newborn infection trials in Eastern Uganda: a nested cohort study within the BabyGel pilot trial.

BACKGROUND: Due to their immature immune system, neonates are at high risk of infection. This vulnerability when combined with limited resources and health education in developing countries can lead to sepsis, resulting in high global neonatal mortality rates. Many of these deaths are preventable. The BabyGel pilot trial tested the feasibility of conducting the main randomised trial, with the provision of alcohol handgel to postpartum mothers for prevention of neonatal infective morbidity in the rural community. This secondary analysis sought to evaluate the methods of detecting infections in babies up to 3 months of age. METHODS: The pilot two-arm cluster randomised controlled trial took place in 10 villages around Mbale, Eastern Uganda. Women were eligible and recruited antenatally if their gestation was ≥ 34 weeks. All infants of mothers participating in the BabyGel pilot trial were followed up for the first 3 months of life. Evidence for infant infection was collected using five different methods: clinician diagnosed infection, microbiologically confirmed infection, maternally reported infection, a positive infection screen using the World Health Organization (WHO) Integrated Management of Childhood Illness (IMCI) screening criteria, and reported antibiotic use identified during home and clinic visits. These methods were assessed quantitatively regarding the detection rates of suspected infections and qualitatively by exploring the challenges collecting data in the rural community setting. RESULTS: A total of 103 eligible women participated in the BabyGel pilot trial, with 1 woman delivering twins. Of the 99 mother-infant pairs who consented to participate in the study, 55 infants were identified with infection in total. Maternal report of illness provided the highest estimate, with mothers reporting suspected illness for 45 infants (81.8% of the total suspected infections identified). The WHO IMCI screening criteria identified 30 infants with suspected infection (54.5%), and evidence for antibiotic use was established in 22 infants (40%). Finally, clinician-diagnosed infection identified 19 cases (34.5%), which were also microbiologically confirmed in 5 cases (9.1%). Data collection in the rural setting was hindered by poor communication between mothers and the research team, limited staff awareness of the study in health centres resulting in reduced safeguarding of clinical notes, and widespread use of antibiotics prior to notification and clinical review. Furthermore, identification of suspected infection may not have been limited to severe infections, with ambiguity and no official clinical diagnosis being given to those identified solely by maternal report of infection. CONCLUSIONS: A high rate of suspected infection was identified spanning the five sources of data collection, but no ideal method was found for detection of community neonatal infection. Although maternal self-reports of infant infection provided the highest detection rate, data collection via each source was limited and may have identified minor rather than major infections. Future studies could utilise the IMCI screening tool to detect severe community infection leading to referral for clinical confirmation. This should be combined with weekly contact with mothers to detect maternally suspected illness. Obtaining more details of the symptoms and timescale will improve the accuracy when detecting the total burden of suspected disease, and advising participants to retain medication packaging and prescriptions will improve identification of antibiotic use. TRIAL REGISTRATION: Babygel pilot trial - trial registration: ISCRCTN 67852437. Registered 02/03/2015.

Meta-analysis of peritoneal lavage in appendicectomy.

Background: The use of peritoneal lavage to prevent postoperative intra-abdominal abscess (IAA) after appendicectomy has been debated widely. Methods: A systematic review and meta-analysis of suction alone versus lavage for appendicitis was performed to determine the relative benefit of lavage. Primary outcomes were postoperative IAA and wound infection (WI). Inclusion criteria were human studies reporting a comparison of appendicectomy with or without peritoneal lavage. Results: Eight studies met the inclusion criteria, the majority of which were retrospective. Only three were RCTs. Four studies included analysis only of the paediatric population. The rate of IAA was 1·0-19·5 per cent in patients receiving suction alone and 1·5-18·6 per cent in those having lavage. WI rates were 1·0-29·2 per cent for suction alone and 0·8-20·5 per cent for lavage. The pooled risk difference for IAA was 0·01 (95 per cent c.i. -0·03 to 0·06; P = 0·50) and that for WI was 0·00 (-0·05 to 0·05; P = 0·98). Analyses of both outcomes indicated a medium degree of heterogeneity between effect estimates with I 2 values of 71 per cent (P = 0·001) and 70 per cent (P = 0·010) for IAA and WI respectively. Conclusion: There is no evidence of benefit of lavage over suction for postoperative infective complications, and no individual study demonstrated a significant benefit in patients receiving lavage.

"We have to clean ourselves to ensure that our children are healthy and beautiful": findings from a qualitative assessment of a hand hygiene poster in rural Uganda.

BACKGROUND: Neonatal sepsis is a major cause of mortality worldwide, with most deaths occurring in low-income countries. The World Health Organisation (WHO) '5 Moments for Hand Hygiene' poster has been used to reduce hospital-acquired infections, but there is no similar tool to prevent community-acquired newborn infections in low-resource settings. This assessment, part of the BabyGel Pilot study, evaluated the acceptability of the 'Newborn Moments for Hand Hygiene in the Home' poster. This was an educational tool which aimed to remind mothers in rural Uganda to clean their hands to prevent neonatal infection. METHODS: The BabyGel pilot was a cluster randomised trial that assessed the post-partum use of alcohol-based hand rub (ABHR) to prevent neonatal infections in Mbale, Uganda. Fifty-five women in 5 village clusters received the ABHR and used it from birth to 3 months postnatally, with use guided by the new poster. Following the study, 5 focus group discussions (FGDs) were conducted consisting of 6-8 purposively sampled participants from intervention villages. FGDs were audio-recorded, transcribed then translated into English. Transcripts were inductively coded using ATLAS.ti® and qualitatively analysed using thematic content analysis. RESULTS: Most mothers reported that they understood the message in the poster ("The picture shows me you must use these drugs to keep your baby healthy") and that they could adhere to the moments from the poster. Some participants used the information from the poster to encourage other caregivers to use the ABHR ("after explaining to them, they liked it"). Other potential moments for hand hygiene were introduced by participants, such as after tending to domestic animals and gardening. CONCLUSION: The poster was well-received, and participants reported compliance with the moments for hand hygiene (although the full body wipe of the baby has since been removed). The poster will be adapted into a sticker format on the ABHR bottle. More focus could be put into an education tool for other caregivers who wish to hold the baby. Overall, the study demonstrated the acceptability of an adapted version of the WHO Moments for Hand Hygiene poster in the introduction of an intervention in the community. TRIAL REGISTRATION: ISRCTN67852437 , registered 02/03/2015. TRIAL FUNDING: Medical Research Council/ Wellcome Trust/ DfID (Global Health Trials Scheme).

Core outcome sets for prevention and treatment of postpartum haemorrhage: an international Delphi consensus study.

OBJECTIVE: To develop core outcome sets (COS) for studies evaluating interventions for (1) prevention and (2) treatment of postpartum haemorrhage (PPH), and recommendations on how to report the COS. DESIGN: A two-round Delphi survey and face-to-face meeting. POPULATION: Healthcare professionals and women's representatives. METHODS: Outcomes were identified from systematic reviews of PPH studies and stakeholder consultation. Participants scored each outcome in the Delphi on a Likert scale between 1 (not important) and 9 (critically important). Results were discussed at the face-to-face meeting to agree the final COS. Consensus at the meeting was defined as ≥ 70% of participants scoring the outcome as critically important (7-9). Lectures, discussion and voting were used to agree how to report COS outcomes. MAIN OUTCOME MEASURES: Outcomes from systematic reviews and consultations. RESULTS: Both Delphi rounds were completed by 152/205 (74%) participants for prevention and 143/197 (73%) for treatment. For prevention of PPH, nine core outcomes were selected: blood loss, shock, maternal death, use of additional uterotonics, blood transfusion, transfer for higher level of care, women's sense of wellbeing, acceptability and satisfaction with the intervention, breastfeeding, and adverse effects. For treatment of PPH, 12 core outcomes were selected: blood loss, shock, coagulopathy, hysterectomy, organ dysfunction, maternal death, blood transfusion, use of additional haemostatic intervention, transfer for higher level of care, women's sense of wellbeing, acceptability and satisfaction with the intervention, breastfeeding, and adverse effects. Recommendations were developed on how to report these outcomes where possible. CONCLUSIONS: These COS will help standardise outcome reporting in PPH trials. TWEETABLE ABSTRACT: Core outcome sets for PPH: nine core outcomes for PPH prevention and 12 core outcomes for PPH treatment.

HIV in Canada-Surveillance Report, 2018.

BACKGROUND: Human immunodeficiency virus (HIV) is a global public health issue, with an estimated 36.9 million people living with HIV in 2017. HIV has been reportable in Canada since 1985 and the Public Health Agency of Canada (PHAC) continues to monitor trends in new HIV diagnoses. OBJECTIVE: The objective of this surveillance report is to provide an overview of the epidemiology of all reported diagnoses of HIV in Canada since 1985 with a focus on 2018 overall, and by geographic location, age group, sex, and exposure category. METHODS: PHAC monitors HIV through the national HIV/AIDS Surveillance System, a passive, case-based system that collates nonnominal data that is voluntarily submitted by all Canadian provinces and territories. Descriptive epidemiological analyses were conducted on national data and those relating to specific populations provided by Immigration, Refugees and Citizenship Canada and the Canadian Perinatal HIV Surveillance Program. RESULTS: In 2018, a total of 2,561 HIV diagnoses were reported in Canada, an increase of 8.2% compared with 2017. The national diagnosis rate increased to 6.9 per 100,000 population in 2018 from 6.5 per 100,000 population in 2017. Saskatchewan reported the highest provincial diagnosis rate at 14.9 per 100,000 population. The 30-39 year age group continued to have the highest HIV diagnosis rate at 15.4 per 100,000 population. Overall, the diagnosis rate for males continued to be higher than that of females (9.8 versus 4.0 per 100,000 population, respectively); however, females experienced a larger increase in reported cases and diagnosis rate. The gay, bisexual and other men who have sex with men (gbMSM) exposure category continued to represent the highest proportion of all reported adult cases (41.4%), though the proportion has decreased over time. Five perinatal HIV transmissions were documented, three were related to the mother not receiving perinatal antiretroviral therapy prophylaxis. CONCLUSION: The number and rate of reported HIV cases in Canada increased in 2018, gbMSM continued to account for the largest exposure category and the number and rate of reported HIV cases among women increased. PHAC will continue to work with its national partners to refine the collection, analysis and publication of national data to better understand the burden of HIV in Canada.

Improving national surveillance of new HIV diagnoses.

The purpose of national HIV surveillance is to track and summarize trends in newly diagnosed cases as an indicator of HIV transmission within Canada, and supports the development and evaluation of programs and policies for prevention, testing and delivery of care. Accurately capturing and interpreting trends in HIV diagnoses within national surveillance becomes complicated when there is movement of people within a country or when individuals are diagnosed with HIV prior to migrating to a new country. This has been identified as an issue in other countries, including Australia, New Zealand and Switzerland. The Public Health Agency of Canada (PHAC) recently assessed this in Canada after noting a rise in new HIV cases in Canada between 2014 to 2017. An environmental scan was conducted to better understand how new and previously diagnosed cases of HIV were recorded by and reported to PHAC from provincial and territorial (PT) public health authorities. It was discovered there was variation with respect to the reporting of cases who had received a new diagnosis of HIV within the province or territory, but who had previously received an HIV diagnosis from another PT or another country. Five PTs included cases previously diagnosed in another Canadian PT within the HIV surveillance data reported to PHAC and nine PTs included people who were diagnosed with HIV outside of Canada. The provincial and territorial public health authorities then reviewed HIV surveillance data from 2007 to 2017 to identify cases using a common definition of "previous HIV-positive test result". This included any case who gave a history, or had laboratory evidence, of an HIV-positive result from another PT or another country before presenting for care in the province or territory where they now resided. When these cases were subtracted from the total, a revised number of new HIV diagnoses was calculated for Canada. Re-analysis of surveillance data using this common definition for 2007 to 2017 explained more than half of the increase in HIV cases that had been documented in Canada over the last four years. In the future, national surveillance data will be calculated adopting this new common definition of a previous positive test result, in order to more accurately describe the trends in HIV transmission occurring in Canada.

Optimising informed consent for participants in a randomised controlled trial in rural Uganda: a comparative prospective cohort mixed-methods study.

BACKGROUND: Poor participant understanding of research information can be a problem in community interventional studies with rural African women, whose levels of illiteracy are high. This study aimed to improve the informed consent process for women living in rural eastern Uganda. We assessed the impact of alternative consent models on participants' understanding of clinical trial information and their contribution to the informed consent process in rural Uganda. METHODS: The study applied a parallel mixed-methods design for a prospective comparative cohort, nested within a pilot study on the community distribution of an alcohol-based hand rub to prevent neonatal sepsis (BabyGel pilot trial). Women of at least 34 weeks' pregnancy, suitable for inclusion in the BabyGel pilot trial, were recruited into this study from their homes in 13 villages in Mbale District. As part of the informed consent process, information about the trial was presented using one of three consent methods: standard researcher-read information, a slide show using illustrated text on a flip chart or a video showing the patient information being read as if by a newsreader in either English or the local language. In addition, all women received the patient information sheet in their preferred language. Each information-giving method was used in recruitment for 1 week. Two days after recruitment, women's understanding of the clinical trial was evaluated using the modified Quality of Informed Consent (QuIC) tool. They were also shown the other two methods and their preference assessed using a 5-point Likert scale. Semi-structured interviews were administered to each participant. The interviews were audio-recorded, transcribed and translated verbatim, and thematically analysed. RESULTS: A total of 30 pregnant women in their homes participated in this study. Their recall of the trial information within the planned 48 h was assessed for the majority (90%, 27/30). For all three consent models, women demonstrated a high understanding of the study. There was no statistically significant difference between the slide-show message (mean 4.7; standard deviation, SD 0.47; range 4-5), video message (mean 4.9; SD 0.33; range 4-5) and standard method (mean 4.5; SD 0.53; range 4-5; all one-way ANOVA, p = 0.190). The slide-show message resulted in the most objective understanding of question items with the highest average QuIC score of 100 points. For women who had been recruited using any of the three models, the slide show was the most popular method, with a mean score for all items of not less than 4.2 (mean 4.8; SD 0.6; range 4-5). Most women (63%, 19/30) preferred the slide-show message, compared with 17% (5/30) and 20% (6/30) for the standard and video messages, respectively. The reasons given included the benefits of having pictures to aid understanding and the logical progression of the information. CONCLUSION: Our results from this small study suggest that slide-show messages may be an effective and popular alternative way of presenting trial information to women in rural Uganda, many of whom have little or no literacy. TRIAL REGISTRATION: ISRCTN, ISRCTN67852437 . Registered on 18 March 2018.

Preventing neonatal sepsis in rural Uganda: a cross-over study comparing the tolerance and acceptability of three alcohol-based hand rub formulations.

BACKGROUND: Neonatal sepsis causes 0.5 million deaths annually, mostly in low resource settings. Babies born in African rural homes without running water or toilet facilities are especially vulnerable. Alcohol-based hand rub (ABHR) may be used by mothers and carers as an alternative to hand washing with soap to prevent neonatal infection. However, no definite study has established the preferred formulation of hand rub for the mothers. This study aimed to assess the effects of addition of bitterants and perfume towards the acceptability of the alcohol-based hand rubs by the mothers in their homes after childbirth. METHODS: This was a 3-way blinded cross-over study design. Mothers with children aged ≤3 months were recruited from immunisation clinics at 3 local health facilities in rural eastern Uganda and received 3-different ABHR formulations (in the order plain, bitterant and perfumed) packed in 100 ml bottles. Each ABHR was used for 5 consecutive days followed by a 2-day 'washout' period (evaluation period). Overall satisfaction with each hand rub was evaluated at the end of each week using a 7-point Likert scale. RESULTS: A total of 43 women were recruited, whose ages ranged from 16 to 45 years (mean 26.2 years old). None of the participants normally used a hand protective lotion/cream. The three formulations were used for a mean of 5 (range 3-7) days. A significantly greater volume of the "bitterant" and "perfumed" formulations (mean 91 and 83 ml respectively) were used in comparison to the "plain" formulation (mean 64 ml). Overall satisfaction was high with all the hand rubs, but the perfumed formulation had a significantly higher overall satisfaction score [mean 6.7, range 4-7] compared with the plain [6.4, 3-7] and bitterant [6.2, 2-7] formulations. CONCLUSIONS: All the 3 ABHR formulations were well accepted with little to choose between them. The ABHR with added perfume scored highest on overall satisfaction and was used significantly more often than plain ABHR. ABHR with bitterant additive did, however, score highly and may be a preferable choice to those with concern over alcohol misuse. TRIAL REGISTRATION: ISRCTN67852437 , prospectively registered on 18/03/2018.