tocol was approved by the Single Joint Research Ethics Board of the Philippine Department of Health (SJREB-2020-24) and the institutional review board of the different study sites. The dissemination of results will be conducted through scientific/medical conferences and through journal publication. The lay versions of the results may be provided on request.

NCT04386083.

NCT04386083.

There is global recognition that low back pain (LBP) should be managed with a biopsychosocial approach. Previous implementation of this approach resulted in low uptake and highlighted the need for ongoing support. This study aims to explore the feasibility of (i) training and using a champion to support implementation, (ii) using a cluster randomised controlled trial (RCT), (iii) collecting patient reported outcome measures in a Canadian public healthcare setting and to identify contextual barriers to implementation.

A pragmatic cluster RCT with embedded qualitative study with physiotherapists treating LBP in publicly funded physiotherapy departments in Newfoundland and Labrador, Canada. Participants will complete a previously developed online training course to equip them to deliver a biopsychosocial intervention for LBP. Clusters randomised to the intervention arm will receive additional support from a champion. A minimum champion training package has been developed based on known barriers in the literaal leads, and patients with LBP.

ClinicalTrials.gov Identifier NCT04377529; Memorial University of Newfoundland Protocol Record 20190025; Pre-results.

ClinicalTrials.gov Identifier NCT04377529; Memorial University of Newfoundland Protocol Record 20190025; Pre-results.

Real-time continuous glucose monitoring (rt-CGM) informs users about current interstitial glucose levels and allows early detection of glycaemic excursions and timely adaptation by behavioural change or pharmacological intervention. Randomised controlled studies adequately powered to evaluate the impact of long-term application of rt-CGM systems on the reduction of adverse obstetric outcomes in women with gestational diabetes (GDM) are missing. We aim to assess differences in the proportion of large for gestational age newborns in women using rt-CGM as compared with women with self-monitored blood glucose (primary outcome). Rates of neonatal hypoglycaemia, caesarean section and shoulder dystocia are secondary outcomes. A comparison of glucose metabolism and quality of life during and after pregnancy completes the scope of this study.

Open-label multicentre randomised controlled trial with two parallel groups including 372 female patients with a recent diagnosis of GDM (between 24+0 until 31+6 weeks of ges8; Pre-results.

NCT03981328; Pre-results.

Informing research participants of the results of studies in which they took part is viewed as an ethical imperative. However, there is little guidance in the literature about how to do this. The Fluoxetine Or Control Under Supervision trial randomised 3127 patients with a recent acute stroke to 6 months of fluoxetine or placebo and was published in

on 5 December 2018. The trial team decided to inform the participants of the results at exactly the same time as

publication, and also whether they had been allocated fluoxetine or placebo. In this report, we describe how we informed participants of the results.

In the 6-month and 12-month follow-up questionnaires, we invited participants to provide an email address if they wished to be informed of the results of the trial. We re-opened our trial telephone helpline between 5 December 2018 and 31 March 2019.

UK stroke services.

3127 participants were randomised. 2847 returned 6-month follow-up forms and 2703 returned 12-month follow-up forms; the remaining participants had died (380), withdrawn consent or did not respond.

Of those returning follow-up questionnaires, a total of 1845 email addresses were provided and a further 50 people requested results to be sent by post. Results were sent to all email and postal addresses provided; 309 emails were returned unrecognised. Seventeen people replied, of whom three called the helpline and the rest responded by email.

It is feasible to disseminate results of large trials to research participants, though only around 60% of those randomised wanted to receive the results. The system we developed was efficient and required very little resource, and could be replicated by trialists in the future.

ISRCTN83290762; Post-results.

ISRCTN83290762; Post-results.

Patients and families affected by a rare disease are burdened in multiple ways. Functional interface management can unburden patients or relatives from the need to be solely accountable for the navigation through the healthcare system. This study aims at (1) providing an assessment of approaches and interface management concepts in the care of rare diseases, (2) evaluating selected existing approaches and concepts and (3) developing best practice recommendations for interface management.

We will conduct a mixed-methods study with three phases. In phase 1, we will develop a tool to assess existing concepts of interface management for rare diseases based on a literature search and an expert workshop. The tool will be applied in a telephone survey with representatives of centres or clinics of expertise for rare diseases (target n=100) and cooperating practitioners (target n=60). Based on the results of phase 1, we will select four to six centres of expertise with interface management concepts, which will be study results, centres are invited to send a representative to a final expert workshop in phase 3. Moreover, an executive summary will be provided and sent to relevant stakeholders.

German Clinical Trials Registry (DRKS00020488).

German Clinical Trials Registry (DRKS00020488).

Neuromyelitis optica spectrum disorders (NMOSD) is an inflammatory and heterogeneous astrocyte disorder of the central nervous system with the characteristic of higher incidence in women and Asian people. Most patients with NMOSD have a course of recurrence and remission that is prone to cause paralysis and blindness. Several studies have confirmed the efficacy and promising prospect of mycophenolate mofetil (MMF) in the treatment of NMOSD. Yet its therapeutic effect and safety are controversial. Although there has been two published literature that is relevant to the topic of this study, both of them have certain defects, and they can only provide answers about the efficacy or safety of MMF in the treatment of NMOSD from partial perspectives or conclusions. This research aims to perform a direct and comprehensive systematic review and meta-analysis to evaluate MMF’s effectiveness and safety in treating NMOSD.

This systematic review will cover all comparative researches, from randomised controlled trials ill be exclusively extracted from published studies, ethical approval and informed consent of patients will not be required. The systematic review will be published in a peer-reviewed journal, presented at conferences and will be shared on social media platforms.

CRD42020164179.

CRD42020164179.

In healthcare policy and economic literature, research on the health technology assessment (HTA) of complex interventions (CIs) is becoming increasingly important. In many developed countries, HTA guides decision-making to help achieve greater value for money when funding health care. However, research has yet to identify the forms of evidence and evaluation criteria that should be used in the HTA of CIs. Previous research has established that the HTA of CIs requires multiple factors to be evaluated but there is no agreement on which factors ought always to be considered. There is equally little agreement on which forms of evidence ought to be collected or synthesised and how. We plan to perform a systematic scoping review in order to identify the range of evaluation criteria and types of evidence currently used in the HTA of CIs.

This protocol was developed to guide the methodological framework for the conduct of a scoping review on health technology assessment (HTA) of complex interventions (CIs), usingation and will also be disseminated at conferences and seminars.

In Europe, the social inequalities in perinatal health are usually found to be to the disadvantage of non-European immigrants and women with lower levels of education and income. Among the possible underlying mechanisms are inadequate access to healthcare services and suboptimal care. To explore this hypothesis in the Belgian context, our research will describe detailed maternal socioeconomic and migration characteristics, explore how these factors relate to each other, and how they relate to women’s perinatal care trajectories and experiences of care.

Using a modified version of the Migrant-Friendly Maternity Care Questionnaire, we will survey 900 mothers of Belgian nationality or a nationality from a North or Sub-Saharan African country, and having given birth in four maternity wards in Brussels. The questionnaire has been adapted to the study objectives and the Belgian context. Interviewers will administer the 116-item questionnaire to all women agreeing to participate and meeting inclusion criteria, wnisations and healthcare professionals via a written report and seminars.

Ethical approval has been obtained from the hospital Ethics Committees and from the Université libre de Bruxelles (No P2017/055/B406201730877). Written informed consent will be sought from all participants.In addition to disseminating findings and recommendations to the scientific community through open-source journal articles and conferences, we will also address local organisations and healthcare professionals via a written report and seminars.

'Emergency medicine (EM) in the UK has a medical staffing crisis.’ Inadequate staffing, in EM and across healthcare, is a problem that affects the quality of patient care globally. Retention of doctors in EM is a particularly acute problem in the UK’s National Health Service. Sustainable careers in healthcare are gaining increasing attention at a national and international policy level, but research to understand the factors that facilitate retention is lacking.This study aims to develop understanding of what drives retention of doctors in EM by focusing on those who remain in these careers, where previous research has targeted those who have left. By addressing the problem of retention in a different way, using innovative methods in this context, we aim to develop a deeper and more nuanced understanding of sustainable careers in EM.

This is an ethnographic study combining participant observation in two emergency departments, interviews with doctors from these departments, from organisations with influencinform understanding of sustainable careers in EM that may be transferable to other settings, professions, and locations that share key characteristics with EM such as paediatrics, emergency nursing and general practice. Findings will be disseminated through a series of academic publications and presentations, through local and specialty research engagement, and through targeted policy statements.

To explore the needs of children and their families after a child’s traumatic injury.

Semi-structured qualitative interviews with purposeful sampling for different types of injuries and a theoretical thematic analysis.

32 participants; 13 children living at home after a traumatic injury, their parents/guardians (n=14) and five parents whose injured child did not participate.

Two Children’s Major Trauma Centres (hospitals) in England.

Interviews were conducted a median 8.5 months (IQR 9.3) postinjury. Injuries affected the limbs, head, chest, abdomen, spine or multiple body parts. Participants highlighted needs throughout their recovery (during and after the hospital stay). Education and training were needed to help children and families understand and manage the injury, and prepare for discharge. Information delivery needed to be timely, clear, consistent and complete, include the injured child, but take into account individuals’ capacity to absorb detail. Similarly, throughout recovery, services needed to be timely and easily accessible, with flexible protocols and eligibility criteria to include injured children.