Clare Relton

Patients and health professionals face difficult decisions every day when choosing between standard‐of‐care treatments for the same disease. In bowel disease, some treatments are used interchangeably, but a lack of evidence may exist as to whether one is more effective than another. Randomised controlled trials provide robust evidence in these settings, but they are expensive, time‐consuming and disruptive to usual care. The introduction of electronic health records (EHR) has created unique opportunities to develop efficient trial designs, such as Decision Architecture Randomised Trials (DART). These implement unobtrusive and sometimes indiscernible EHR ‘nudges’, prompting clinicians towards one treatment or another. There is no obligation for clinicians to use the assigned intervention or for the patient to accept it. However, the association between the assignment and the actual treatment received can be used to estimate unbiased treatment effects. We discuss the key features of DART studies and outline the persisting uncertainties to operationalising this study design in clinical practice.

Background: Worldwide, minority youth receive culturally sensitive mental health services less often than the majority peer population. In Norway, limited research exists on the mental health and service use among youth from national minority (Forrest Finns, Kven or Norwegian Finns, Jews, Roma, and Romani), Indigenous (Sámi), and refugee backgrounds. Although the Norwegian government provides a public communication channel for youth, including mental health information and support, digital services have not been adapted to meet the needs of these groups. There is currently no research to determine the use, acceptability, effectiveness, cost-effectiveness, and safety of these services for these youth. Objective: The main aim of the InvolveMENT project is to improve the mental health of national minority, Indigenous, and refugee youth. The project’s objectives are, for these groups of youth, to (1) determine the mental health and digital support needs and possible barriers to and facilitators of service use; (2) assess the use of and satisfaction with digital services to meet their mental health needs; (3) explore their perspectives on digital mental health services; (4) develop recommendations that can be used to adapt digital services to meet their needs and rights; and (5) assess the use, acceptability, satisfaction, effectiveness, cost-effectiveness, and safety of adapted services. Methods: The 4-year InvolveMENT project consists of four phases: (1) establishing a longitudinal cohort consisting of national minority, Indigenous, and refugee youth, using surveys to assess their mental health, well-being, digital support needs, use and satisfaction with digital services, and possible barriers to and facilitators of service use; (2) conducting qualitative interviews with minority youth to explore their perspectives and synthesizing data from phases 1 and 2 for a mixed methods analysis; (3) involving youth and health care and other professionals to develop proposals to adapt and improve the existing digital services; and (4) a randomized controlled trial and a qualitative study to evaluate the adapted services. Results: Cohort and qualitative study designs have been completed. Ethics applications have been approved, and recruitment to the cohort and qualitative studies has started. Conclusions: The InvolveMENT project has the potential to enhance the accessibility and quality of health care services and early interventions, reduce inequality in service provision for minority groups, and strengthen collaboration between youth, public, and research organizations. Through this, it has the potential to improve the mental health of youth from these groups. The findings might be transferable to other minority groups, both nationally and internationally.

Introduction In the UK, approximately 5.4 million adults live with asthma, of whom one in five have an uncontrolled form. Uncontrolled asthma reduces quality of life and increases healthcare use. Engaging with peers through online health communities (OHCs) can empower patients to self-manage their long-term condition. While OHCs have been in existence for several years and growing numbers of patients access them, the role of primary care in signposting patients to them has been minimal and ad hoc. We have co-developed with patients and healthcare professionals (HCPs) an intervention for adult patients with asthma, consisting of an appointment with a primary care HCP to introduce online peer support and sign patients up to an established asthma OHC, followed by OHC engagement. Feasibility work found the intervention acceptable to patients and HCPs. This protocol outlines our plan to test the intervention’s effectiveness and cost-effectiveness. Methods and analysis An individual randomised controlled trial will be carried out. Eligible participants will be recruited via an online survey sent to adult patients on the asthma register in 50–70 general practices in several UK locations. Participants will be invited to attend a one-off, face-to-face appointment with a primary care HCP, during which they will be individually randomised to the intervention or usual care. An asthma control test (primary outcome) and other measures of clinical effectiveness will be collected at baseline and every 3 months over a 12-month follow-up period. Descriptive and inferential statistics will be used to compare outcome measures between study arms. Cost-effectiveness assessment of the intervention compared with current standard of asthma management in primary care will be reported. A sample of patients and HCPs will be interviewed at study exit and the data analysed thematically. Ethics and dissemination The study was approved by a National Health Service Research Ethics Committee (reference: 25/NE/0006). Written consent will be obtained from all participants. Findings will be disseminated through various means, including sharing with general practices, conference presentations and peer-reviewed publications. Trial registration number NCT06849245.

BACKGROUND Worldwide, minority youth less commonly receive culturally sensitive mental health services than the majority peer population. In Norway, limited research exists on the mental health and service use among youth from national minority (Forrest Finns, Kven/Norwegian Finns, Jews, Roma, and Romani), Indigenous (Sámi), and refugee backgrounds. Although the Norwegian government provides a public communication channel for youth, including mental health information and support, digital services have not been adapted to meet the needs of these groups. There is no research to determine the use, acceptability, effectiveness, cost-effectiveness and safety of these services for these youth. OBJECTIVE The main aim of the InvolveMENT project is to improve the mental health of national minority, Indigenous and refugee youth. The project’s objectives are, for these groups of youth, to: (1) Determine mental health and digital support needs, and possible barriers and facilitators to service use; (2) Assess use of and satisfaction with digital services to meet their mental health needs; (3) Explore their perspectives on digital mental health services; (4) Develop recommendations which can be used to adapt digital services to meet their needs and rights; and (5) Assess the use, acceptability, satisfaction, effectiveness, cost-effectiveness and safety of adapted services. METHODS The four-year InvolveMENT project consists of four phases: 1) Establishing a longitudinal cohort consisting of national minority, Indigenous and refugee youth, using surveys to assess their mental health, wellbeing, digital support needs, utilization and satisfaction with digital services, and possible barriers and facilitators to service use. 2) Conducting qualitative interviews with minority youth to explore their perspectives, and synthesizing data from phase 1 and 2 for a mixed methods analysis. 3) Involving youth, and healthcare and other professionals to develop proposals to adapt and improve the existing digital services. 4) A randomized controlled trial (RCT) and a qualitative study to evaluate the adapted services. RESULTS Cohort and qualitative study designs are completed. An ethics application has been submitted, and recruitment is scheduled to begin after its approval. CONCLUSIONS The InvolveMENT project has the potential to enhance the accessibility and quality of healthcare services, early interventions, reduce inequality in service provision for minority groups, and strengthen collaboration between youth, public and research organizations. Through this, it has the potential to improve mental health of youth from these groups. Findings might be transferable to other minority groups, both nationally and internationally. CLINICALTRIAL ISRCTN21223142. Available at https://doi.org/10.1186/ISRCTN21223142

5.4 million people in the UK have asthma, with one third experiencing suboptimal control, leading to co-morbidities and increased healthcare use. A quarter of people with long-term conditions informally access peer support through online health communities (OHCs). However, integrating online peer support into primary care services to facilitate self-management is a new concept. To develop together with stakeholders the content, delivery, and recruitment strategy of a digital social intervention to promote use of online peer support amongst asthma patients in primary care. Data was collected by qualitative, audio-recorded, one-to-one interviews with clinicians, and focus groups with patients with asthma from East London general practices. The topic guide was informed by patient and public involvement work. Data collected was iterative (i.e. new ideas were added to subsequent interviews and focus groups). Verbatim transcripts were uploaded to NVivo12 and thematically analysed. Twenty patients from several ethnicities participated across five focus groups, and three general practitioners and three practice nurses were interviewed. The study's outputs included: the intervention's face-to-face content; content of clinician training; patient-facing leaflets/material; and a survey to recruit eligible patients. An intervention consisting of a structured consultation with a primary care clinician followed by OHC engagement, was developed based on three generated themes: 'introducing OHCs', describing how clinicians should introduce OHCs; 'OHC engagement', describing factors influencing OHC engagement; and 'clinician training'. Findings will assist clinicians in consultations about supporting self-management of patients through OHCs. Future research should evaluate feasibility, effectiveness, and cost-effectiveness of such support.

Background: Breast-feeding holds considerable potential to reduce infant mortality. Feeding choices, already complex, take on additional complexity against a backdrop of the risk of transmissible Ebola Virus. This review describes the factors that influence infant feeding and attitudes of pregnant women, mothers, family members and health practitioners, policy makers and providers (midwives) concerning infant feeding when there is a risk of Mother-to-Child (MTC) transmission of Ebola Virus Disease (EVD). Methodology: A systematic review of qualitative studies identified through rigorous searches of thirteen online databases and additional citation searches of included studies was undertaken. Search terms included breast-feeding, breast-feeding, infant feeding; Ebola; and qualitative, interview(s) and findings. Independent extraction of data by two reviewers using predefined extraction forms. Studies were assessed using the CASP Qualitative checklist. Principal findings: 5219 references were screened. 38 references related specifically to Ebola, and five papers met the inclusion criteria with data gathered from two settings: Guinea and Sierra Leone. The EVD outbreak had a significant impact on beliefs, attitudes, and resources to support infant feeding practices negatively affecting the nutritional status of children. The evidence from these studies highlight the need for guidance and appropriate psychosocial support need to be available to mothers who display symptoms and become infected and to front-line staff who are giving advice. Communities need to be engaged because stigma and fear may hinder uptake of appropriate interventions. The EVD outbreak caused multi-level system disruption akin to that seen following a natural disaster, meaning that logistics and coordination are critical and need adequate resourcing. Food production and distribution, and malnutrition screening are also disrupted and thereby compounding compromised nutritional status. The limited number of relevant studies highlights the need for further primary research, particularly in translation of messages to local settings. Conclusions: An EVD outbreak causes multi-level disruption that negatively impacts infant feeding and child care practices. Negative impacts have multiple causes and successful planning for Ebola outbreaks requires that nutrition of infants and young children is a priority. Lessons from the Ebola pandemic have wider applicability to other pandemic contexts including Covid-19.

Objective: To evaluate patients’ experience of having served as controls without explicit notification in the context of the Trial within Cohorts (TwiCs) design. Study design: Cohort participants with breast or rectal cancer, who had served as controls in an exercise respectively radiotherapy dose-escalation TwiCs, were asked for their experience of having (unknowingly) served as controls in TwiCs in a survey. At cohort entry, patients had provided broad consent to randomization. Results: Survey response rates were 76% (n=110/145). Two to six years after cohort entry, 15% (n=16) of all patients remembered having provided broad consent to randomization. After disclosure of trial results, 53% (n=57) of patients thought positively, 41% (n=44) neutrally and 1% (n=1) negatively of having served as controls in one of the two trials. Twenty-two percent (n=24) of patients were positive, 62% (n=66) neutral and 7% (n=7) negative about not having been notified when serving as controls. Conclusions: A large majority of patients reported positively or neutrally of unknowingly having served as controls in TwiCs. The recollection of having provided broad consent to randomization was poor at 2-6 years after cohort entry.