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ObjectivesTo (1) assess women’s current knowledge regarding long-term cardiovascular health after hypertensive disorders of pregnancy (2) elicit women’s preferred educational content and format regarding health after hypertensive disorders of pregnancy.Design and settingA custom-created online survey exploring Australian women’s knowledge about long-term health after hypertensive disorders of pregnancy, distributed through consumer groups and social media.Participants266 women with (n=174) or without (n=92) a history of hypertensive disorders of pregnancy.Primary and secondary outcome measures(1) Proportion of women identifying long-term health risks after hypertensive disorder of pregnancy using a 10-point risk knowledge score with 0–4 ‘low’, 4.1–7.0 ‘moderate’ and 7.1–10 ‘high’. (2) Exploration of preferred content, format and distribution of educational material post hypertensive disorder of pregnancy.ResultsKnowledge scores about health after hypertensive disorder of pregnancy were moderate in groups with and without a history of the disorder. Knowledge was highest regarding risk of recurrent hypertensive disorders in a subsequent pregnancy, ‘moderate’ for chronic hypertension and heart attack, ‘moderate’ and ‘low’ regarding risk of heart disease and ‘low’ for diabetes and renal disease. Only 36% of all participants were aware that risks start within 10 years after the affected pregnancy. The majority of respondents with a history of hypertensive disorder of pregnancy (76%) preferred receiving information about long-term health 0–6 months post partum from a healthcare provider (80%), key organisations (60%), social media (47%) and brochures/flyers (43%).ConclusionsWomen’s knowledge regarding health risks after hypertensive disorder of pregnancy was ‘moderate’, although with important disease-specific gaps such as increased risk of diabetes. Most women wanted to be informed about their long-term health from a healthcare provider.

ObjectiveTo examine the use and out-of-pocket expenses resulting from consultations, products and practices across conventional, self-care, and complementary medicine (CM) treatments for osteoarthritis (OA) among Australian women.Design, setting and participantsA cross-sectional survey of 800 women from the 45 and Up Study who had reported a clinical diagnosis of OA.Outcome measuresWomen’s use of conventional, CM and self-prescribed treatments for OA and the associated out-of-pocket cost.ResultsCompleted questionnaires were returned by 403 women (50.4%). Their average time since the first diagnosis of OA was 15.4 years, and self-rated severity of OA was 5.1 (out of 10) over the past 12 months. During the previous year, 67.0% of the women consulted a doctor, 39.2% consulted an allied health practitioner and 34.7% consulted a CM practitioner for their OA. Some women (19%) consulted with practitioner(s) from all three practitioner groups, 27% consulted with practitioner(s) from two of the three practitioner groups, while 6% consulted with a CM practitioner only. Women with a greater time since diagnosis had more consultations, as did women who rated their OA as more severe. Women’s average combined out-of-pocket expenditure for OA-related healthcare consultations, prescription medications, products, and practices was $673 per annum. Extrapolated to all Australian women with OA, aged 50 years and over, the total out-of-pocket expenditure for this condition is estimated to be $873 million per annum.ConclusionsAustralian women with OA use a range of conventional and CM consultations, self-care, products and practices to manage their condition, incurring significant out-of-pocket expenses. Given the high individual and societal burden of OA, there is a need for further research into the concurrent use of different healthcare resources with a view to providing safe, cost-effective management of OA across the healthcare system and the wider community.

ObjectivesThis review aimed to determine the pooled prevalence of preoperative anxiety and its associated factors among patients undergoing surgery in low/middle-income countries (LMICs).MethodsWe searched PubMed, SCOPUS, CINAHL, Embase and PsychINFO to identify peer-reviewed studies on the prevalence and factors associated with preoperative anxiety among patients undergoing surgery using predefined eligibility criteria. Studies were pooled to estimate the prevalence of preoperative anxiety using a random-effect meta-analysis model. Heterogeneity was assessed using I² statistics. Funnel plot asymmetry and Egger’s regression tests were used to check for publication bias.ResultOur search identified 2110 studies, of which 27 studies from 12 countries with 5575 participants were included in the final meta-analysis. Of the total 27 studies, 11 used the State-Trait Anxiety Inventory to screen anxiety, followed by the Amsterdam Preoperative Anxiety and Information scale, used by four studies. The pooled prevalence of preoperative anxiety among patients undergoing surgery in LMICs was 55.7% (95% CI 48.60 to 62.93). Our subgroup analysis found that a higher pooled prevalence of preoperative anxiety was found among female surgical patients (59.36%, 95% CI 48.16 to 70.52, I2=95.43, p2=97.48, pConclusionOur meta-analysis indicated that around one in two patients undergoing surgery in LMICs suffer from preoperative anxiety, which needs due attention. Routine screening of preoperative anxiety symptoms among patients scheduled for surgery is vital.PROSPERO registration numberCRD42020161934.

ObjectiveTo evaluate the implementation of National Institute for Health and Care Excellence antenatal hypertension guidelines, to identify strategies to reduce incidences of severe hypertension and associated maternal and perinatal morbidity and mortality in pregnant women with chronic hypertension.MethodsWe used a multiple method multisite approach to establish implementation of guidelines and the associated barriers and facilitators. We used a national survey of healthcare professionals (n=97), case notes review (n=55) and structured observations (n=42) to assess implementation. The barriers and facilitators to implementation were identified from semistructured qualitative interviews with healthcare professionals (n=13) and pregnant women (n=18) using inductive thematic analysis. The findings were integrated and evaluated using the Consolidated Framework for Implementation Research.Setting and participantsPregnant women with chronic hypertension and their principal carers (obstetricians, midwives and physicians), at three National Health Service hospital trusts with different models of care.ResultsWe found severe hypertension to be prevalent (46% of case notes reviewed) and target blood pressure practices to be suboptimal (56% of women had an antenatal blood pressure target documented). Women were infrequently given information (52%) or offered choice (19%) regarding antihypertensives. Women (14/18) reported internal conflict in taking antihypertensives and non-adherence was prevalent (8/18). Women who were concordant with treatment recommendations described having mutual trust with professionals mediated through appropriate information, side effect management and involvement in decision making. Professionals reported needing updates and tools for target blood pressure setting and shared decision making underpinned by antihypertensive safety and effectiveness research.ConclusionsWomen’s non-adherence to antihypertensives is higher than anticipated. Suboptimal information provision around treatment, choice of antihypertensives and target setting practices by healthcare professionals may be contributory. Understanding the reasons for non-adherence will inform education and decision-making strategies needed to address both clinician and women’s behaviour. Further research into the effectiveness and long-term safety of common antihypertensives is also required.

IntroductionVariation in test ordering is a major issue in Australia and globally with significant financial and clinical impacts. There is currently a lack of research identifying and remediating variation in the use of pathology tests in emergency departments (EDs). In 2019, NSW Health Pathology introduced the Pathology Atlas of Variation that uses a data-driven tool (the Atlas Analytical Model) to investigate test order variation across New South Wales (NSW) and engage with local health districts (LHDs) to reduce variation. The objectives of this study are to evaluate whether this data-driven approach is associated with: (1) a reduction in test order variation; (2) improvements in patient outcomes and (3) cost benefits, for the five most frequent ED presentations.Methods and analysisThis is a large multisite study including 45 major public hospitals across 15 LHDs in NSW, Australia. The Atlas Analytical Model is a data analytics and visualisation tool capable of providing analytical insights into variation in pathology investigations across NSW EDs, which will be used as feedback to inform LHDs efforts to reduce variation. Interrupted time series analyses using 2 years pre Atlas (2017–2018) and 2 years post Atlas (2021–2022) data will be conducted. Study data will be obtained by linking hospital and laboratory databases. Funnel plots will be used to identify EDs with outlying pathology test ordering practices. The outcome measures include changes in test ordering practices, ED length of stay, hospital admission and cost benefits (total pathology costs per ED encounter).Ethics and disseminationThe study has received ethical approval from the NSW Population and Health Service Research Ethics Committee (reference, 2019/ETH00184). The findings of the study will be published in peer-reviewed journals and disseminated via presentations at conferences. We will also engage directly with key stakeholders to disseminate the findings and to inform policies related to pathology testing in the ED.

ObjectivesTo evaluate an implementation programme of a community pharmacy medication review with follow-up (MRF) service using a hybrid effectiveness-implementation study design, and to compare the clinical and humanistic outcomes with those in a previously conducted cluster randomised controlled trial (cRCT).SettingCommunity pharmacies in Spain.Participants135 community pharmacies and 222 pharmacists providing MRF to polymedicated patients aged 65 or over.InterventionThe intervention was an implementation programme for the MRF service. A national level group was established, mirrored with a provincial level group. A series of interventions were defined (1) to engage pharmacy owners with the implementation model and (2) to provide training to pharmacists consisting of clinical case studies, process of MRF, communication skills and data collection methods and (3) practice change facilitators.Primary and secondary outcome measuresThe primary outcomes for the implementation programme were progress, reach, fidelity and integration. The secondary outcomes were number of medications, non-controlled health problems, emergency visits, hospitalisations and health-related quality of life, which were compared with a previous 6-month cluster RCT.Results55% of pharmacies reached the implementation phase and 35.6% remained in the testing phase at 12 months. A reach of 89.3% (n=844) was achieved. Fidelity average score was 8.45 (min: 6.2, max: 9.3) out of 10. The integration mean score was 3.39 (SD: 0.72) out of 5. MRF service outcomes were similar to the cluster RCT study; however, the magnitude of the outcomes was delayed.ConclusionsThe implementation of pharmacy services is a complex multifactorial process, conditioned by numerous implementation factors. In the absence of remuneration, the implementation of the MRF service is a slow process, taking at least 12 months to complete.Trial registration numberCGFTRA-2017-01.

IntroductionThrough addressing main barriers to the uptake of long-acting reversible contraceptives (LARCs) among Australian women, the Australian Contraceptive ChOice pRoject (ACCORd) trialled an educational intervention targeting general practitioners (GPs) and provided those in the intervention group with a rapid referral service for quick insertion. The cluster randomised controlled trial resulted in greater uptake of LARC in the intervention group. This protocol paper describes a longitudinal follow-up to the ACCORd Study to assess the long-term efficacy and cost-effectiveness of the intervention.Methods and analysisWomen participants (patients of ACCORd GPs) completed a baseline, 6-month and 12-month survey. These participants will be invited to complete an additional follow-up survey 3 years post completion of their baseline interview. Based on the original ACCORd Study tools, the online survey will address long-term outcomes including contraceptive continuation rates and reproductive history, any unintended pregnancies, satisfaction and concerns with their current contraceptive method, and an assessment of quality of life. We will analyse data using binary regression models with generalised estimating equations and robust standard errors to account for clustering.DiscussionDemonstration of sustained use, effectiveness at reducing unwanted pregnancies and cost-effectiveness of this strategy among this cohort of Australian primary care patients, will strengthen the policy and programme urgency of addressing wider dissemination of these strategies and replicating the study elsewhere.Ethics and disseminationThe ACCORd Study received approval from the Monash University Human Research Ethics Committee: CF16/188-201000080. Additionally, an amendment to conduct this 3-year longitudinal follow-up survey has been approved. The trial follow-up outcomes will be disseminated through formal academic pathways, including journal articles, national and international conferences and reports as well as using more ‘mainstream’ strategies such as seminars, workshops and media engagement. Additionally, outcomes will be communicated through policy briefs to Australian state and federal governments.Trail registration numberThis trial is registered with the Australian and New Zealand Trials Registry ACTRN12615001346561. Recruitment and data collection have been completed for the baseline, 6-month and 12-month surveys. Data collection for the 3-year survey commenced in August 2019.

IntroductionVasa previa is a condition where fetal blood vessels run unprotected in the membranes, outside the umbilical cord, and cross the internal opening of the cervix. During rupture of membranes, these vessels can rupture and put the baby at serious risk of severe blood loss and death. Numerous studies are being conducted to improve diagnostic modalities and establish clear management plans to improve pregnancy outcomes. However, the lack of a standardised set of outcomes for studies on vasa previa makes it difficult to compare study findings and draw meaningful conclusions. Through this project, we will be developing a core outcome set for studies on pregnant women with vasa previa (COVasP).Methods and analysisThe development of COVasP will involve five steps. The first will be a systematic review, in which we will generate a long list of outcomes based on published studies in pregnancies complicated with vasa previa. The second will involve in-depth interviews with current and former patients, their family members and healthcare providers who care for these patients. This will be followed by a two-round Delphi survey, which will aim to narrow down the long list of outcomes into those considered important by four groups of ‘stakeholders’: (1) patients, family members and patient advocates/representatives, (2) healthcare providers, (3) researchers, epidemiologists and methodologists and (4) other stakeholders directly or indirectly involved in the management of these pregnancies such as administrators, guideline developers and policymakers. The fourth step will involve a face-to-face consensus meeting using a nominal group approach to establish a finalised core outcome set. The final step will involve measuring and defining the identified outcomes using a combination of systematic reviews and Delphi surveys.Ethics and disseminationThis study as well as consent forms for stakeholder participation have received approval from the Mount Sinai Hospital Research Ethics Board (REB number 18-0173-E) on 05 September 2018 and the Human Research Ethics Committee at The University of Technology Sydney, Australia on 30 July 2019 (UTS HREC reference number ETH19-3718). All progress will be documented on the international prospective register of systematic reviews and Core Outcome Measures in Effectiveness Trials databases.Registration detailshttp://www.comet-initiative.org/studies/details/1117.

IntroductionWith almost 50% of cases preventable and the Australian National Bowel Cancer Screening Program in place, colorectal cancer (CRC) is a prime candidate for investment to reduce the cancer burden. The challenge is determining effective ways to reduce morbidity and mortality and their implementation through policy and practice. Pathways-Bowel is a multistage programme that aims to identify best-value investment in CRC control by integrating expert and end-user engagement; relevant evidence; modelled interventions to guide future investment; and policy-driven implementation of interventions using evidence-based methods.Methods and analysisPathways-Bowel is an iterative work programme incorporating a calibrated and validated CRC natural history model for Australia (Policy1-Bowel) and assessing the health and cost outcomes and resource use of targeted interventions. Experts help identify and prioritise modelled evaluations of changing trends and interventions and critically assess results to advise on their real-world applicability. Where appropriate the results are used to support public policy change and make the case for optimal investment in specific CRC control interventions. Fourteen high-priority evaluations have been modelled or planned, including evaluations of CRC outcomes from the changing prevalence of modifiable exposures, including smoking and body fatness; potential benefits of daily aspirin intake as chemoprevention; increasing CRC incidence in people aged Pathways-Bowel is a unique, comprehensive approach to evaluating CRC control; no prior body of work has assessed the relative benefits of a variety of interventions across CRC development and progression to produce a list of best-value investments.Ethics and disseminationEthics approval was not required as human participants were not involved. Findings are reported in a series of papers in peer-reviewed journals and presented at fora to engage the community and policymakers.

ObjectivesSolid organ transplant recipients are at increased risk of skin cancer, affecting more than 50% of recipients. We aimed to determine the effectiveness of interventions for behavioural change for sun protection or skin cancer prevention in solid organ transplant recipients.DesignSystematic review.Data sourcesWe searched MEDLINE, Embase, the Cochrane Central Register of Controlled Trials (CENTRAL) and CINAHL from inception to November 2019.Eligibility criteriaWe included randomised controlled trials that evaluated the effect of behavioural or pharmaceutical interventions on behavioural change or skin cancer prevention in solid organ transplant recipients.Data extraction and synthesisRisks of bias and evidence certainty were assessed using Cochrane and the Grading of Recommendations Assessment Development and Evaluation framework.ResultsTwenty trials (n=2295 participants) were included. It is uncertain whether behavioural interventions improve sun protection behaviour (n=3, n=414, standardised mean difference (SMD) 0.89, 95% CI −0.84 to 2.62, I2=98%) and knowledge (n=4, n=489, SMD 0.50, 95% CI 0.12 to 0.87, I2= 76%) as the quality of evidence is very low. We are uncertain of the effects of mammalian target of rapamaycin inhibitors on the incidence of non-melanocytic skin cancer (n=5, n=1080, relative risk 0.46, 95% CI 0.28 to 0.75, I2 =72%) as the quality of evidence is very low.ConclusionsBehavioural and pharmaceutical preventive interventions may improve sun protective behaviour and knowledge, and reduce the incidence of non-melanocytic skin cancer, but the overall quality of the evidence is very low and insufficient to guide decision-making and clinical practice.PROSPERO registration numberCRD42017063962.

IntroductionEye diseases and visual impairment more commonly affect elderly adults, thus, the majority of ophthalmic cohort studies have focused on older adults. Cohort studies on the ocular health of younger adults, on the other hand, have been few. The Raine Study is a longitudinal study that has been following a cohort since their birth in 1989–1991. As part of the 20-year follow-up of the Raine Study, participants underwent a comprehensive eye examination. As part of the 27- and 28-year follow-ups, eye assessments are being conducted and the data collected will be compared with those of the 20-year follow-up. This will provide an estimate of population incidence and updated prevalence of ocular conditions such as myopia and keratoconus, as well as longitudinal change in ocular parameters in young Australian adults. Additionally, the data will allow exploration of the environmental, health and genetic factors underlying inter-subject differential long-term ocular changes.Methods and analysisParticipants are being contacted via telephone, email and/or social media and invited to participate in the eye examination. At the 27-year follow-up, participants completed a follow-up eye screening, which assessed visual acuity, autorefraction, ocular biometry and ocular sun exposure. Currently, at the 28-year follow-up, a comprehensive eye examination is being conducted which, in addition to all the eye tests performed at the 27-year follow-up visit, includes tonometry, optical coherence tomography, funduscopy and anterior segment topography, among others. Outcome measures include the incidence of refractive error and pterygium, an updated prevalence of these conditions, and the 8-year change in ocular parameters.Ethics and disseminationThe Raine Study is registered in the Australian New Zealand Clinical Trials Registry. The Gen2 20-year, 27-year and 28-year follow-ups are approved by the Human Research Ethics Committee of the University of Western Australia. Findings resulting from the study will be published in health or medical journals and presented at conferences.Trial registration numberACTRN12617001599369; Active, not recruiting.

ObjectivesGastrostomy decision making is a complicated, multifaceted process for people with motor neuron disease (MND). This study explored demographic and disease-related factors that may impact on gastrostomy uptake; and reasons why people with MND accepted or declined gastrostomy, with a focus on how perceptions of swallowing and nutrition may influence decision making.DesignProspective, cross sectional, mixed methods.SettingAn Australian multidisciplinary, specialty MND Service.Participants33 patients were recommended gastrostomy by the treating medical specialist. 16 of 33 were invited to participate in the prospective decision making study; of whom 10 provided informed consent.Primary and secondary outcome measuresDemographic and disease-related factors contributing to uptake are described. A stepped approach was applied to gain a comprehensive understanding of why people with MND accept or decline gastrostomy. Instruments included standardised assessments, nutrition survey and semistructured interview. Data were collected at three separate appointments, spanning a 3-week period.ResultsGastrostomy uptake was 73% following medical specialist recommendation. Participants took days, weeks or months to consider their preferences, with lengthy hospital waiting times for the procedure. Gender, site of onset and rate of disease progression were observed to contribute to uptake. Age and symptom duration did not. Integration of quantitative and qualitative data suggests that patient perceptions of swallowing and nutrition contribute to gastrostomy acceptance; however, the decision making process is heterogeneous and these factors may not be the sole or primary reasons for acceptance. Other reported factors included: reducing carer burden, improving quality of life, increasing independence, continuing participation in social outings and gaining control.ConclusionsFuture research may give greater insight into how healthcare organisations can better facilitate gastrostomy decision making, to meet the needs of people living with MND. Larger, prospective, multisite studies may build on these findings to better inform clinical guidelines and minimise the impacts of delayed gastrostomy insertion.

IntroductionSelf-monitoring of blood pressure (BP) in pregnancy could improve the detection and management of pregnancy hypertension, while also empowering and engaging women in their own care. Two linked trials aim to evaluate whether BP self-monitoring in pregnancy improves the detection of raised BP during higher risk pregnancies (BUMP 1) and whether self-monitoring reduces systolic BP during hypertensive pregnancy (BUMP 2).Methods and analysesBoth are multicentre, non-masked, parallel group, randomised controlled trials. Participants will be randomised to self-monitoring with telemonitoring or usual care. BUMP 1 will recruit a minimum of 2262 pregnant women at higher risk of pregnancy hypertension and BUMP 2 will recruit a minimum of 512 pregnant women with either gestational or chronic hypertension. The BUMP 1 primary outcome is the time to the first recording of raised BP by a healthcare professional. The BUMP 2 primary outcome is mean systolic BP between baseline and delivery recorded by healthcare professionals. Other outcomes will include maternal and perinatal outcomes, quality of life and adverse events. An economic evaluation of BP self-monitoring in addition to usual care compared with usual care alone will be assessed across both study populations within trial and with modelling to estimate long-term cost-effectiveness. A linked process evaluation will combine quantitative and qualitative data to examine how BP self-monitoring in pregnancy is implemented and accepted in both daily life and routine clinical practice.Ethics and disseminationThe trials have been approved by a Research Ethics Committee (17/WM/0241) and relevant research authorities. They will be published in peer-reviewed journals and presented at national and international conferences. If shown to be effective, BP self-monitoring would be applicable to a large population of pregnant women.Trial registration numberNCT03334149

ObjectiveOne in 20 women are affected by pre-eclampsia, a major cause of maternal and perinatal morbidity, death and premature birth worldwide. Diagnosis is made from monitoring blood pressure (BP) and urine and symptoms at antenatal visits after 20 weeks of pregnancy. There are no randomised data from contemporary trials to guide the efficacy of self-monitoring of BP (SMBP) in pregnancy. We explored the perspectives of maternity staff to understand the context and health system challenges to introducing and implementing SMBP in maternity care, ahead of undertaking a trial.DesignExploratory study using a qualitative approach.SettingEight hospitals, English National Health Service.ParticipantsObstetricians, community and hospital midwives, pharmacists, trainee doctors (n=147).MethodsSemi-structured interviews with site research team members and clinicians, interviews and focus group discussions. Rapid content and thematic analysis undertaken.ResultsThe main themes to emerge around SMBP include (1) different BP changes in pregnancy, (2) reliability and accuracy of BP monitoring, (3) anticipated impact of SMBP on women, (4) anticipated impact of SMBP on the antenatal care system, (5) caution, uncertainty and evidence, (6) concerns over action/inaction and patient safety.ConclusionsThe potential impact of SMBP on maternity services is profound although nuanced. While introducing SMBP does not reduce the responsibility clinicians have for women’s health, it may enhance the responsibilities and agency of pregnant women, and introduces a new set of relationships into maternity care. This is a new space for reconfiguration of roles, mutual expectations and the relationships between and responsibilities of healthcare providers and women.Trial registration numberNCT03334149.

ObjectiveHealth extension workers’ (HEWs’) knowledge and attitude regarding mental health problems are vital for integrating mental healthcare into primary healthcare services. However, information in this context is scarce in Ethiopia. So, this study aimed to assess HEWs' knowledge and attitude towards mental health problems in Jimma, Ethiopia.DesignA cross-sectional study.SettingFive districts in Jimma Zone, Ethiopia, 2020.ParticipantsA total of 259 HEWs working in selected five districts were included in the study.OutcomeThe knowledge and attitude status of HEWs towards mental health problems.ResultsNearly half of the respondents had inadequate knowledge (122,47.1%) and an unfavourable attitude (125, 48.3%). Most (139, 53.7%) described mental illness as due to evil spirits’ possession. Almost all (240, 92.7%) of the respondents reported talking or laughing alone as a manifestation of mental illness. Almost two-thirds (157, 60.6%) of the respondents reported people with mental illness are dangerous. About a quarter (63, 24.3%) of the participants stated witch doctors should manage mental illnesses.ConclusionsA significant proportion of the study respondents had poor knowledge and attitude towards mental health problems. Short-term and long-term mental health training is needed to improve their perception level and to provide effective community mental health services.

IntroductionManagement of neuropathic cancer pain (NCP) refractory to regular opioids remains an important challenge. The efficacy of pregabalin for NCP except chemotherapy-induced peripheral neuropathy (CIPN) has already been confirmed in two randomised controlled trials (RCTs) compared with placebo. Duloxetine offers the potential of analgesia in opioid refractory NCP. However, there are no RCT of duloxetine for the management of opioid-refractory NCP as a first line treatment. Both classes of drugs have the potential to reduce NCP, but there has been no head-to-head comparison for the efficacy and safety, especially given differing side effect profiles.Methods and analysisAn international, multicentre, double-blind, dose increment, parallel-arm, RCT is planned. Inclusion criteria include: adults with cancer experiencing NCP refractory to opioids; Brief Pain Inventory (BPI)-item 3 (worst pain) of ≥4; Neuropathic Pain on the Leeds Assessment of Neuropathic Symptoms and Signs Pain Scale of ≥12 despite of an adequate trial of regular opioid medication (≥60 mg/day oral morphine equivalent dose). Patients with CIPN are excluded.The study will recruit from palliative care teams (both inpatients and outpatients) in Japan and Australia. Participants will be randomised (1:1 allocation ratio) to duloxetine or pregabalin arm. Dose escalation is until day 14 and from day 14 to 21 is a dose de-escalation period to avoid withdrawal effects. The primary endpoint is defined as the mean difference in BPI item 3 for worst pain intensity over the previous 24 hours at day 14 between groups. A sample size of 160 patients will be enrolled between February 2020 and March 2023.Ethics and disseminationEthics approval was obtained at Osaka City University Hospital Certified Review Board and South Western Sydney Local Health District Human Research Ethics Committee. The results of this study will be submitted for publication in international journals and the key findings presented at international conferences.Trial registration numbersjRCTs051190097, ACTRN12620000656932.

ObjectiveThe International Learning Collaborative (ILC) is an organisation dedicated to understanding why fundamental care, the care required by all patients regardless of clinical condition, fails to be provided in healthcare systems globally. At its 11th annual meeting in 2019, nursing leaders from 11 countries, together with patient representatives, confirmed that patients’ fundamental care needs are still being ignored and nurses are still afraid to ‘speak up’ when these care failures occur. While the ILC’s efforts over the past decade have led to increased recognition of the importance of fundamental care, it is not enough. To generate practical, sustainable solutions, we need to substantially rethink fundamental care and its contribution to patient outcomes and experiences, staff well-being, safety and quality, and the economic viability of healthcare systems.Key argumentsWe present five propositions for radically transforming fundamental care delivery:Value: fundamental care must be foundational to all caring activities, systems and institutionsTalk: fundamental care must be explicitly articulated in all caring activities, systems and institutions.Do: fundamental care must be explicitly actioned and evaluated in all caring activities, systems and institutions.Own: fundamental care must be owned by each individual who delivers care, works in a system that is responsible for care or works in an institution whose mission is to deliver care.Research: fundamental care must undergo systematic and high-quality investigations to generate the evidence needed to inform care practices and shape health systems and education curricula.ConclusionFor radical transformation within health systems globally, we must move beyond nursing and ensure all members of the healthcare team—educators, students, consumers, clinicians, leaders, researchers, policy-makers and politicians—value, talk, do, own and research fundamental care. It is only through coordinated, collaborative effort that we will, and must, achieve real change.

IntroductionChildren and young people with intellectual disability represent one of the most vulnerable groups in healthcare, yet they remain under-represented in projects to design, develop and/or improve healthcare service delivery. Increasingly, healthcare services are using various codesign and coproduction methodologies to engage children and young people in service delivery improvements.Methods and analysisThis study employs an inclusive approach to the study design and execution, including two co-researchers who are young people with intellectual disability on the project team. We will follow an adapted experience-based co-design methodology to enable children and young people with intellectual disability to participate fully in the co-design of a prototype tool for eliciting patient experience data from children and young people with intellectual disability in hospital.Ethics and disseminationThis study was granted ethical approval on 1 February 2021 by the Sydney Children’s Hospitals Network Human Research Ethics Committee, reference number 2020/ETH02898. Dissemination plan includes publications, doctoral thesis chapter, educational videos. A summary of findings will be shared with all participants and presented at the organisation quality and safety committee.

ObjectiveThis study assessed the changes in prevalence and associated factors of tobacco smoking among Bangladeshi adults over time.DesignNationally representative cross-sectional surveys.SettingTwo most recent Global Adults Tobacco Survey (GATS) data from Bangladesh, carried out in 2009 and 2017.ParticipantsAdult population aged 15 and above (n=9629 in 2009; n=12 783 in 2017).Outcome measuresCurrent use of tobacco smoke, including cigarettes, bidi, hukkah, cigars or pipes, which was dichotomised (‘yes’/‘no’).MethodsWe analysed data from two recent rounds of GATS (2009 and 2017). Multivariate logistic regression analysis was used.ResultsThe overall prevalence of tobacco smoking among Bangladeshi adults was noted (23.00%, 95% CI 22.98 to 23.00 in 2009; 16.44%, 95% CI 16.43 to 16.45 in 2017). Being male (adjusted OR (AOR)=59.72, CI 40.56 to 87.93 for 2009; AOR=71.17, CI 41.08 to 123.32 for 2017), age between 25 and 64 years (all AORs >2 and pConclusionsAlthough the prevalence of tobacco smoking has declined over the period, it is still high among those who were relatively older, men, less educated and exposed to a movie/drama where tobacco smoking is promoted. Therefore, appropriate interventions are required to stop tobacco smoking among the Bangladeshi population.

IntroductionDespite higher incidence of brain injury among Aboriginal compared with non-Aboriginal Australians, suboptimal engagement exists between rehabilitation services and Aboriginal brain injury survivors. Aboriginal patients often feel culturally insecure in hospital and navigation of services post discharge is complex. Health professionals report feeling ill-equipped working with Aboriginal patients. This study will test the impact of a research-informed culturally secure intervention model for Aboriginal people with brain injury.Methods and analysisDesign:Stepped wedge cluster randomised control trial design; intervention sequentially introduced at four pairs of healthcare sites across Western Australia at 26-week intervals.Recruitment:Aboriginal participants aged ≥18 years within 4 weeks of an acute stroke or traumatic brain injury.Intervention:(1) Cultural security training for hospital staff and (2) local, trial-specific, Aboriginal Brain Injury Coordinators supporting participants.Primary outcome: Quality-of-life using EuroQOL-5D-3L (European Quality of Life scale, five dimensions, three severity levels) Visual Analogue Scale score at 26 weeks post injury. Recruitment of 312 participants is estimated to detect a difference of 15 points with 80% power at the 5% significance level. A linear mixed model will be used to assess the between-condition difference.Secondary outcome measures: Modified Rankin Scale, Functional Independence Measure, Modified Caregiver Strain Index, Hospital Anxiety and Depression Scale at 12 and 26 weeks post injury, rehabilitation occasions of service received, hospital compliance with minimum care processes by 26 weeks post injury, acceptability of Intervention Package, feasibility of Aboriginal Brain Injury Coordinator role.Evaluations: An economic evaluation will determine the potential cost-effectiveness of the intervention. Process evaluation will document fidelity to study processes and capture changing contexts including barriers to intervention implementation and acceptability/feasibility of the intervention through participant questionnaires at 12 and 26 weeks.Ethics and disseminationThe study has approvals from Aboriginal, university and health services human research ethics committees. Findings will be disseminated through stakeholder reports, participant workshops, peer-reviewed journal articles and conference papers.Trial registration numberACTRN12618000139279.

ObjectivesThis study aimed at examining the association between young maternal age at first childbirth and under-5 mortality in sub-Saharan Africa (SSA).Design and settingThis cross-sectional study pooled nationally-representative data from the most recent Demographic and Health Surveys conducted in 30 countries in SSA from 2010 to 2019.Participants116 379 mothers of children under 5.ResultsThe prevalence of adolescent childbirth and death in children under 5 in SSA were 57.36% (95% CI 53.73% to 60.99%) and 4.10% (95% CI 3.65% to 4.54%), respectively. Children born to mothers whose first childbirth occurred at ConclusionsThe findings call for the need to enhance policies aimed at reducing under-5 mortality in SSA by reducing adolescent pregnancy and childbirth through family planning, comprehensive sexuality education, and the elimination of child marriage. Again, Since under-5 mortality among adolescent mothers is linked with their poor socio-economic status, there is the need for government and non-governmental organisations in SSA to introduce poverty alleviation programmes and improve access to both formal and informal education as a way of enhancing the socioeconomic status of adolescent mothers. Public health education, through continuous advocacy programmes should be done to encourage adolescent mothers to access antenatal care and health facility deliveries as a way of enhancing the survival status of their children. These interventions should be implemented, taking into consideration other characteristics of mothers such marital status and BMI and child’s characteristics such as child’s weight, which were found to be associated with high under-5 mortality.

ObjectivesThis study aimed to explore the relationship (presence and severity) between chronic breathlessness and sleep problems, independently of diagnoses and health service contact by surveying a large, representative sample of the general population.SettingAnalysis of the 2017 South Australian Health Omnibus Survey, an annual, cross-sectional, face-to-face, multistage, clustered area systematic sampling survey carried out in Spring 2017.Chronic breathlessness was self-reported using the ordinal modified Medical Research Council (mMRC; scores 0 (none) to 4 (housebound)) where breathlessness has been present for more than 3 of the previous 6 months. ‘Sleep problems—ever’ and ‘sleep problem—current’ were assessed dichotomously. Regression models were adjusted for age; sex and body mass index (BMI).Results2900 responses were available (mean age 48.2 years (SD=18.6); 51% were female; mean BMI 27. 1 (SD=5.9)). Prevalence was: 2.7% (n=78) sleep problems—past; 6.8% (n=198) sleep problems—current and breathlessness (mMRC 1–4) was 8.8% (n=254). Respondents with sleep problemspast were more likely to be breathless, older with a higher BMI and sleep problems—present also included a higher likelihood of being female.After adjusting for age, sex and BMI, respondents with chronic breathlessness had 1.9 (95% CI=1.0 to 3.5) times the odds of sleep problems—past and sleep problems—current (adjusted OR=2.3; 95% CI=1.6 to 3.3).ConclusionsThere is a strong association between the two prevalent conditions. Future work will seek to understand if there is a causal relationship using validated sleep assessment tools and whether better managing one condition improves the other.

IntroductionPeople of Ashkenazi Jewish (AJ) ancestry are more likely than unselected populations to have a BRCA1/2 pathogenic variant, which cause a significantly increased risk of breast, ovarian and prostate cancer. Three specific BRCA1/2 pathogenic variants, referred to as BRCA-Jewish founder mutations (B-JFM), account for >90% of BRCA1/2 pathogenic variants in people of AJ ancestry. Current practice of identifying eligible individuals for BRCA testing based on personal and/or family history has been shown to miss at least 50% of people who have one of these variants. Here we describe the protocol of the JeneScreen study—a study established to develop and evaluate two different population-based B-JFM screening programmes, offered to people of Jewish ancestry in Sydney and Melbourne, Australia.Methods and analysisTo rmeasure the acceptability of population-based B-JFM screening in Australia, two screening programmes using different methodologies have been developed. The Sydney JeneScreen programme provides information and obtains informed consent by way of an online tool. The Melbourne JeneScreen programme does this by way of community sessions attended in person. Participants complete questionnaires to measure clinical and psychosocial outcomes at baseline, and for those who have testing, 2 weeks postresult. Participants who decline testing are sent a questionnaire regarding reasons for declining. Participants with a B-JFM are sent questionnaires 12-month and 24-month post-testing. The questionnaires incorporate validated scales, which measure anxiety, decisional conflict and regret, and test-related distress and positive experiences, and other items specifically developed or adapted for the study. These measures will be assessed for each programme and the two population-based B-JFM screening methods will be compared.Ethics and disseminationInstitutional Human Research Ethics Committee approval was obtained from the South Eastern Area Health Service Human Research Ethics Committee: HREC Ref 16/125.Following the analysis of the study results, the findings will be disseminated widely through conferences and publications, and directly to participants in writing.

IntroductionSpecialised early intervention services have demonstrated improved outcomes in first-episode psychosis (FEP); however, clinical gains may not be sustained after patients are transferred to regular care. Moreover, many patients with FEP remain socially isolated with poor functional outcomes. To address this, our multidisciplinary team has developed a moderated online social media therapy (HORYZONS) designed to enhance social functioning and maintain clinical gains from specialist FEP services. HORYZONS merges: (1) peer-to-peer social networking; (2) tailored therapeutic interventions; (3) expert and peer-moderation; and (4) new models of psychological therapy (strengths and mindfulness-based interventions) targeting social functioning. The aim of this trial is to determine whether following 2 years of specialised support and 18-month online social media-based intervention (HORYZONS) is superior to 18 months of regular care.Methods and analysisThis study is a single-blind randomised controlled trial. The treatment conditions include HORYZONS plus treatment as usual (TAU) or TAU alone. We recruited 170 young people with FEP, aged 16–27 years, in clinical remission and nearing discharge from Early Psychosis Prevention and Intervention Centre, Melbourne. The study includes four assessment time points, namely, baseline, 6-month, 12-month and 18-month follow-up. The study is due for completion in July 2018 and included a 40-month recruitment period and an 18-month treatment phase. The primary outcome is social functioning at 18 months. Secondary outcome measures include rate of hospital admissions, cost-effectiveness, vocational status, depression, social support, loneliness, self-esteem, self-efficacy, anxiety, psychological well-being, satisfaction with life, quality of life, positive and negative psychotic symptoms and substance use. Social functioning will be also assessed in real time through our Smartphone Ecological Momentary Assessment tool.Ethics and disseminationMelbourne Health Human Research Ethics Committee (2013.146) provided ethics approval for this study. Findings will be made available through scientific journals and forums and to the public via social media and the Orygen website.Trial registration numberACTRN12614000009617; Pre-results.

IntroductionHospitals commonly examine patient safety culture and other quality indicators to evaluate and improve performance in relation to quality and safety. A growing body of research has separately examined relationships between patient safety culture and patient experience on clinical outcomes and other quality indicators. However, there is a knowledge gap regarding the relationship between these two important domains. This article describes the protocol for a scoping review of published literature examining the relationship between patient safety culture and patient experience in hospital settings. The scoping review will provide an overview of research into the relationship between patient safety culture and patient experience in hospital contexts, map key concepts underpinning these domains and identify research gaps for further study.Methods and analysisThe scoping review will be conducted using the five stages of Arksey and O’Malley’s framework: identify the research question; identify relevant studies; study selection; chart data; and collate, summarise and report the results. The inclusion criteria will be applied using the Population, Concept and Context Framework. Searches will be conducted in the CINAHL, Cochrane Library, ProQuest, MEDLINE, PsycINFO, Scopus and SciELO databases, without applying date range limits. Hand-searching of grey literature will also be performed to find relevant, non-indexed literature. Data will be extracted using a standardised data extraction form developed by the Joanna Briggs Institute. Both descriptive and thematic analyses will be undertaken to scope key concepts within the body of reviewed literature.Ethics and disseminationThis type of study does not require an ethics review. The results will be submitted for publication in a peer-reviewed journal and presented at conferences.

IntroductionCrohn’s disease and ulcerative colitis are common chronic idiopathic inflammatory bowel diseases (IBD), which cause considerable morbidity. Although the precise mechanisms of disease remain unclear, evidence implicates a strong multidirectional interplay between diet, environmental factors, genetic determinants/immune perturbations and the gut microbiota. IBD can be brought into remission using a number of medications, which act by suppressing the immune response. However, none of the available medications address any of the underlying potential mechanisms. As we understand more about how the microbiota drives inflammation, much interest has focused on identifying microbial signals/triggers in the search for effective therapeutic targets. We describe the establishment of the Australian IBD Microbiota (AIM) Study, Australia’s first longitudinal IBD bioresource, which will identify and correlate longitudinal microbial and metagenomics signals to disease activity as evaluated by validated clinical instruments, patient-reported surveys, as well as biomarkers. The AIM Study will also gather extensive demographic, clinical, lifestyle and dietary data known to influence microbial composition in order to generate a more complete understanding of the interplay between patients with IBD and their microbiota.MethodsThe AIM Study is an Australian multicentre longitudinal prospective cohort study, which will enrol 1000 participants; 500 patients with IBD and 500 healthy controls over a 5-year period. Assessment occurs at 3 monthly intervals over a 24-month period. At each assessment oral and faecal samples are self-collected along with patient-reported outcome measures, with clinical data also collected at baseline, 12 and 24 months. Intestinal tissue will be sampled whenever a colonoscopy is performed. Dietary intake, general health and psychological state will be assessed using validated self-report questionnaires. Samples will undergo metagenomic, transcriptomic, proteomic, metabolomic and culturomic analyses. Omics data will be integrated with clinical data to identify predictive biomarkers of response to therapy, disease behaviour and environmental factors in patients with IBD.Ethics and disseminationEthical approval for this study has been obtained from the South Eastern Sydney Local Health District Research Ethics Committee (HREC 2019/ETH11443). Findings will be reported at national and international gastroenterology meetings and published in peer-reviewed journals.Trial registration numberACTRN12619000911190.

IntroductionStudies regarding the management of malignant bowel obstruction (MBO) report conflicting findings. This is partly due to different outcome measures being used to evaluate severity of MBO and the response to treatments. Furthermore, current outcome measures focus mainly on measurable physiological parameters which may not correlate strongly with patient-defined quality of life. The development of core outcome sets allows a consistent approach to evaluating clinical conditions taking into consideration patient, healthcare professional and researcher viewpoints. It follows an internationally recognised standard methodology. We present a protocol for the development of a core outcome set for Research and Assessment of MBO (RAMBO).MethodsRAMBO is a multicentre study, comprising of four phases: a systematic review to examine current scope of outcome measures associated with MBO (phase I). Interviews with patients, companions and healthcare professionals will explore priorities and preferences for care and outcomes (phase II). An expert panel meeting will collate the findings into a set of outcomes (phase III), refined by consensus through a Delphi survey with key stakeholders (phase IV). The final set of outcomes will be ratified at a consensus meeting. Each step will actively include patient partners. Thematic analysis and descriptive statistics will be used to analyse qualitative and quantitative data, respectively.Ethics and disseminationEthical approval was obtained (Wales REC 5, REF: 19/LO/1876). Study participants and relevant stakeholders will be updated with newsletters and a lay summary at the end of the study. Abstracts will be submitted to national and international conferences, result papers will be submitted to peer-reviewed, open access journals.Trial and PROSPERO registration numbersCore Outcome Measures in Effectiveness Trials (1402); Systematic Literature Review (CRD42019150648); Rapid Review (CRD42020176393).

ObjectivesTo examine the relationship between school playground size and total physical activity (PA), fitness and fundamental movement skills (FMS) of primary school students.DesignCross-sectional ecological analysis.Setting43 primary schools in New South Wales, Australia.ParticipantsData were from 5238 students, aged 5 to 12 years, participating in the Schools Physical Activity and Nutrition Survey.Outcome measuresSelf (for age ≥11 years) and parent (for age ResultsAssociations between playground space and measures of PA and fitness were mostly non-linear and moderated by loose equipment. Students in schools with no loose equipment showed a weak association between space and meeting PA recommendations (self-report). In schools with equipment, students’ predicted probability of meeting PA recommendations increased sharply between 15 m2 and 25 m2 per student from 0.04 (95% CI: 0.01 to 0.08) to 0.30 (95% CI: 0.14 to 0.46), but at 30 m2 returned to levels comparable to students in schools with no equipment (0.18, 95% CI: 0.07 to 0.28). For cardiorespiratory fitness, in schools with no loose equipment, probabilities for being in the healthy cardiovascular fitness zone varied between 0.66 and 0.77, showing no consistent trend. Students in schools with loose equipment had a predicted probability of being in the healthy fitness zone of 0.56 (95% CI: 0.41 to 0.71) at 15 m2 per student, which rose to 0.75 (95% CI: 0.63 to 0.86) at 20 m2 per student. There was no relationship between space and FMS.ConclusionsSchool space guidelines need to incorporate sufficient playground space for students. Our study provides evidence supporting better PA outcomes with increasing space up to 25 m2 per student, and access to loose equipment, however further research is required to determine precise thresholds for minimum space. Intersectoral planning and cooperation is required to meet the needs of growing school populations.

ObjectiveTo explore the perspectives of general practitioners (GPs) concerning the risk of opioid misuse in people with cancer and pain and related clinical considerations.DesignA qualitative approach using semistructured telephone interviews. Analysis used an integrative approach.SettingPrimary care.ParticipantsAustralian GPs with experience of prescribing opioids for people with cancer and pain.ResultsTwenty-two GPs participated, and three themes emerged. Theme 1 (Misuse is not the main problem) contextualised misuse as a relatively minor concern compared with pain control and toxicity, and highlighted underlying systemic factors, including limitations in continuity of care and doctor expertise. Theme 2 (‘A different mindset’ for cancer pain) captured participants’ relative comfort in prescribing opioids for pain in cancer versus non-cancer contexts, and acknowledgement that compassion and greater perceived community acceptance were driving factors, in addition to scientific support for mechanisms and clinical efficacy. Participant attitudes towards prescribing for people with cancer versus non-cancer pain differed most when cancer was in the palliative phase, when they were unconcerned by misuse. Participants were equivocal about the risk–benefit ratio of long-term opioid therapy in the chronic phase of cancer, and were reluctant to prescribe for disease-free survivors. Theme 3 (‘The question is always, ‘how lazy have you been?’) captured participants’ acknowledgement that they sometimes prescribed opioids for cancer pain as a default, easier option compared with more holistic pain management.ConclusionsFindings highlight the role of specific clinical considerations in distinguishing risk of opioid misuse in the cancer versus non-cancer population, rather than diagnosis per se. Further efforts are needed to ensure continuity of care where opioid prescribing is shared. Greater evidence is needed to guide opioid prescribing in disease-free survivors and the chronic phase of cancer, especially in the context of new treatments for metastatic disease.

IntroductionTraumatic spinal cord injuries have significant consequences both for the injured individual and the healthcare system, usually resulting in lifelong disability. Evidence has shown that timely medical and surgical interventions can lead to better patient outcomes with implicit cost savings. Potentially preventable secondary complications are therefore indicators of the effectiveness of acute care following traumatic injury. The extent to which policy and clinical variation within the healthcare service impact on outcomes and acute care costs for patients with traumatic spinal cord injury (TSCI) in Australia is not well described.Methods and analysisA comprehensive data set will be formed using record linkage to combine patient health and administrative records from seven minimum data collections (including costs), with an existing data set of patients with acute TSCI (Access to Care Study), for the time period June 2013 to June 2016. This person-level data set will be analysed to estimate the acute care treatment costs of TSCI in New South Wales, extrapolated nationally. Subgroup analyses will describe the associated costs of secondary complications and regression analysis will identify drivers of higher treatment costs. Mapping patient care and health service pathways of these patients will enable measurement of deviations from best practice care standards and cost-effectiveness analyses of the different pathways.Ethics and disseminationEthics approval has been obtained from the New South Wales Population and Health Services Research Ethics Committee. Dissemination strategies include peer-reviewed publications in scientific journals and conference presentations to enable translation of study findings to clinical and policy audiences.

Introduction With limited funds available, meeting global health targets requires countries to both mobilize and prioritize their health spending. Within this context, countries have recognized the importance of allocating funds for HIV as efficiently as possible to maximize impact. Over the past six years, the governments of 23 countries in Africa, Asia, Eastern Europe and Latin America have used the Optima HIV tool to estimate the optimal allocation of HIV resources. Methods Each study commenced with a request by the national government for technical assistance in conducting an HIV allocative efficiency study using Optima HIV. Each study team validated the required data, calibrated the Optima HIV epidemic model to produce HIV epidemic projections, agreed on cost functions for interventions, and used the model to calculate the optimal allocation of available funds to best address national strategic plan targets. From a review and analysis of these 23 country studies, we extract common themes around the optimal allocation of HIV funding in different epidemiological contexts. Results and discussion The optimal distribution of HIV resources depends on the amount of funding available and the characteristics of each country's epidemic, response and targets. Universally, the modelling results indicated that scaling up treatment coverage is an efficient use of resources. There is scope for efficiency gains by targeting the HIV response towards the populations and geographical regions where HIV incidence is highest. Across a range of countries, the model results indicate that a more efficient allocation of HIV resources could reduce cumulative new HIV infections by an average of 18% over the years to 2020 and 25% over the years to 2030, along with an approximately 25% reduction in deaths for both timelines. However, in most countries this would still not be sufficient to meet the targets of the national strategic plan, with modelling results indicating that budget increases of up to 185% would be required. Conclusions Greater epidemiological impact would be possible through better targeting of existing resources, but additional resources would still be required to meet targets. Allocative efficiency models have proven valuable in improving the HIV planning and budgeting process.

IntroductionPhysical activity, healthy eating and maintaining a healthy weight are associated with reduced risk of cardiovascular disease, type 2 diabetes and cancer and with improved mental health. Despite these benefits, many men do not meet recommended physical activity guidelines and have poor eating behaviours. Many health promotion programmes hold little appeal to men and consequently fail to influence men’s health practices. HAT TRICK was designed as a 12-week face-to-face, gender-sensitised intervention for overweight and inactive men focusing on physical activity, healthy eating and social connectedness and was delivered in collaboration with a major junior Canadian ice hockey team (age range 16–20 years). The programme was implemented and evaluated to assess its feasibility. This article describes the intervention design and study protocol of HAT TRICK.Methods and analysisHAT TRICK participants (n=60) were men age 35 years, residing in the Okanagan Region of British Columbia, who accumulate 150 min of moderate to vigorous physical activity a week, with a body mass index of >25 kg/m2and a pant waist size of >38’. Each 90 min weekly session included targeted health education and theory-guided behavioural change techniques, as well as a progressive (ie, an increase in duration and intensity) group physical activity component. Outcome measures were collected at baseline, 12 weeks and 9 months and included the following: objectively measured anthropometrics, blood pressure, heart rate, physical activity and sedentary behaviour, as well as self-reported physical activity, sedentary behaviour, diet, smoking, alcohol consumption, sleep habits, risk of depression, health-related quality of life and social connectedness. Programme feasibility data (eg, recruitment, satisfaction, adherence, content delivery) were assessed at 12 weeks via interviews and self-report.Ethics and disseminationEthical approval was obtained from the University of British Columbia Okanagan Behavioural Research Ethics Board (reference no H1600736). Study findings will be disseminated through academic meetings, peer-reviewed publication, web-based podcasts, social media, plain language summaries and co-delivered community presentations.Trial registration numberISRCTN43361357,Pre results

ObjectivesMethotrimeprazine is commonly used for the management of nausea but never tested formally against other drugs used in this setting. The aim was to demonstrate superior antiemetic efficacy.DesignDouble-blind, randomised, controlled trial of methotrimeprazine versus haloperidol.Setting11 palliative care sites in Australia.ParticipantsParticipants were >18 years, had cancer, an average nausea score of ≥3/10 and able to tolerate oral medications. Ineligible patients had acute nausea related to treatment, nausea for which a specific antiemetic was indicated, were about to undergo a procedure or had received either of the study drugs or a change in glucocorticoid dose within the previous 48 hours.InterventionsBased on previous studies, haloperidol was used as the control. Participants were randomised to encapsulated methotrimeprazine 6·25 mg or haloperidol 1·5 mg one time or two times per day and assessed every 24 hours for 72 hours.Main outcome measuresA ≥two-point reduction in nausea score at 72 hours from baseline. Secondary outcome measures were as follows: complete response at 72 hours (end nausea score less than 3), response at 24 and 48 hours, vomiting episodes, use of rescue antiemetics, harms and global impression of change.ResultsResponse to treatment at 72 hours was 75% (44/59) in the haloperidol (H) arm and 63% (36/57) in the methotrimeprazine (M) arm with no difference between groups (intention-to-treat analysis). Complete response rates were 56% (H) and 51% (M). In theper protocolanalysis, there was no difference in response rates: (85% (44/52) (H) and 74% (36/49) (M). Completeper protocolresponse rates were 64% (H) and 59% (M). Toxicity worse than baseline was minimal with a trend towards greater sedation in the methotrimeprazine arm.ConclusionThis study did not demonstrate any difference in response rate between methotrimeprazine and haloperidol in the control of nausea.Trial registration numberACTRN 12615000177550.

INTRODUCTION: Physical activity is a cost-effective and non-pharmaceutical strategy that can help mitigate the physical and psychological health challenges associated with breast cancer survivorship. However, up to 70% of women breast cancer survivors are not meeting minimum recommended physical activity guidelines. Project MOVE is an innovative approach to increase physical activity among breast cancer survivors through the use of Action Grants, a combination of microgrants (small amounts of money awarded to groups of individuals to support a physical activity initiative) and financial incentives. The purpose of this paper is to describe the rationale and protocol of Project MOVE. METHOD AND ANALYSIS: A quasi-experimental pre-post design will be used. Twelve groups of 8-12 adult women who are breast cancer survivors (N=132) were recruited for the study via face-to-face meetings with breast cancer-related stakeholders, local print and radio media, social media, and pamphlets and posters at community organisations and medical clinics. Each group submitted a microgrant application outlining their proposed physical activity initiative. Successful applicants were determined by a grant review panel and informed of a financial incentive on meeting their physical activity goals. An evaluation of feasibility will be guided by the reach, effectiveness, adoption, implementation, maintenance (RE-AIM) framework and assessed through focus groups, interviews and project-related reports. Physical activity will be assessed through accelerometry and by self-report. Quality of life, motivation to exercise and social connection will also be assessed through self-report. Assessments will occur at baseline, 6 months and 1 year. ETHICS AND DISSEMINATION: Ethical approval was obtained from the University of British Columbia's Behavioural Research Ethics Board (#H14-02502) and has been funded by the Canadian Cancer Society Research Institute (project number #702913). Study findings will be disseminated widely through peer-reviewed publications, academic conferences, local community-based presentations, as well as partner organisations, including the Canadian Cancer Society.

OBJECTIVE: To assess the effectiveness of models of antenatal care designed to prevent and reduce preterm birth (PTB) in pregnant women.METHODS: We conducted a search of seven electronic databases and reference lists of retrieved studies to identify trials from inception up to July 2014 where pregnant women, regardless of risk factors for pregnancy complications, were randomly allocated to receive an alternative model of antenatal care or routine care. We pooled risks of PTB to determine the effect of alternative care models in all pregnant women. We also assessed secondary maternal and infant outcomes, women's satisfaction and economic outcomes.RESULTS: 15 trials involving 22 437 women were included. Pregnant women in alternative care models were less likely to experience PTB (risk ratio 0.84, 95% CI 0.74 to 0.96). The subgroup of women randomised to midwife-led continuity models of antenatal care were less likely to experience PTB (0.78, 0.66 to 0.91) but there was no significant difference between this group and women allocated to specialised care (0.92, 0.76 to 1.12) (interaction test for subgroup differences p=0.20). Overall low-risk women in alternative care models were less likely to have PTB (0.74, 0.59 to 0.93), but this effect was not significantly different from that in mixed-risk populations (0.91, 0.79 to 1.05) (subgroup p=0.13).CONCLUSIONS: Alternative models of antenatal care for all pregnant women are effective in reducing PTB compared with routine care, but no firm conclusions could be drawn regarding the relative benefits of the two models. Future research should evaluate the impact of antenatal care models which include more recent interventions and predictive tests, and which also offer continuity of care by midwives throughout pregnancy.PROSPERO REGISTRATION NUMBER: CRD42014007116.