Impact of education and training on LGBT-specific health issues for healthcare students and professionals: a systematic review of comparative studies.

Objectives: Training/education is increasingly used to improve healthcare professionals' knowledge, attitudes and clinical skills about lesbian, gay, bisexual and transgender (LGBT) health, but few reviews have assessed their effectiveness. This review describes the impact of training about LGBT healthcare for healthcare professionals on participants' knowledge, attitudes and clinical practice.

Design: Systematic review of intervention studies with contemporaneous comparators.

A toolkit for capturing a representative and equitable sample in health research.

Research participants often do not represent the general population. Systematic exclusion of particular groups from research limits the generalizability of research findings and perpetuates health inequalities. Groups considered underserved by research include those whose inclusion is lower than expected based on population estimates, those with a high healthcare burden but limited research participation opportunities and those whose healthcare engagement is less than others.

Retaining public health volunteers beyond COVID-19.

Objectives: The COVID-19 pandemic has led to a change in people's volunteering behaviours; participation has increased in informal volunteering (giving unpaid help to those who are not a relative) while decreasing in formal volunteering (unpaid help to groups or clubs). There is an interest from stakeholders who have experienced increased participation in maintaining the positive patterns of volunteering, aligning with National Health Service (NHS) objectives and realising benefits in a wider public health context. This research uses a local COVID-19 public health volunteering programme case study to explore the volunteer's journey and perspective using volunteers' reported experiences to consider the potential for volunteer retention and role expansion into other public health issues beyond the COVID-19 pandemic.

Development and usability testing of an electronic patient-reported outcome (ePRO) solution for patients with inflammatory diseases in an Advanced Therapy Medicinal Product (ATMP) basket trial.

Background: Electronic patient-reported outcome (ePRO) systems are increasingly used in clinical trials to provide evidence of efficacy and tolerability of treatment from the patient perspective. The aim of this study is twofold: (1) to describe how we developed an electronic platform for patients to report their symptoms, and (2) to develop and undertake usability testing of an ePRO solution for use in a study of cell therapy seeking to provide early evidence of efficacy and tolerability of treatment and test the feasibility of the system for use in later phase studies.

Methods: An ePRO system was designed to be used in a single arm, multi-centre, phase II basket trial investigating the safety and activity of the use of ORBCEL-C™ in the treatment of patients with inflammatory conditions.

Development of a core outcome set for use in adult primary glioma phase III interventional trials: A mixed methods study.

Background: Glioma interventional studies should collect data aligned with patient priorities, enabling treatment benefit assessment and informed decision-making. This requires effective data synthesis and meta-analyses, underpinned by consistent trial outcome measurement, analysis, and reporting. Development of a core outcome set (COS) may contribute to a solution.

Extended brief interventions for weight management and obesity prevention in children: A rapid evidence review.

Uptake of child weight management (CWM) support is typically low, and services are not available in all areas. Extended brief interventions (EBIs) have been proposed as an affordable way to provide enhanced support, at a level between one-off brief advice and intensive CWM programs. This rapid systematic review sought to synthesize evidence on the efficacy of EBIs for weight management and obesity prevention in children (2-18 years).

Identifying patient-valued outcomes for use in early phase trials of ocular surface disease interventions.

Background: Patient-reported outcomes (PROs) can be used to evaluate the impact of dry eye symptoms (DES) on daily life. Early-phase clinical trials provide an opportunity to evaluate PRO strategies. Existing measures identified through systematic review omitted important concepts that mattered to patients.

Feasibility of a new electronic patient-reported outcome (ePRO) system for an advanced therapy clinical trial in immune-mediated inflammatory disease (PROmics): protocol for a qualitative feasibility study.

Introduction: The use of electronic patient-reported outcome (ePRO) systems to capture PRO data in clinical trials is increasing; however, their feasibility, acceptability and utility in clinical trials of advanced therapy medicinal products (ATMPs) are not yet well understood. This protocol describes a qualitative study that aims to evaluate the feasibility and acceptability of ePRO data capture using a trial-specific ePRO system (the PROmics system) within an advanced therapy trial involving patients with immune-mediated inflammatory disease (rheumatoid arthritis, lupus, primary sclerosing cholangitis (PSC) and Crohn's disease).

Methods And Analysis: This protocol for a remote, qualitative, interview-based feasibility study is embedded within the POLARISE trial, a single-arm, phase II, multisite ATMP basket trial in the UK.

Development of a core outcome set and identification of patient-reportable outcomes for primary brain tumour trials: protocol for the COBra study.

Introduction: Primary brain tumours, specifically gliomas, are a rare disease group. The disease and treatment negatively impacts on patients and those close to them. The high rates of physical and cognitive morbidity differ from other cancers causing reduced health-related quality of life.

Real-time remote outpatient consultations in secondary and tertiary care: A systematic review of inequalities in invitation and uptake.

Background: Health policies in most high income countries increasingly recommend provision of routine outpatient care via remote (video and/or telephone) appointments, especially due to the pandemic. This is thought to improve access to care and promote efficiency within resource-constrained health services. There is limited evidence about the impact on existing inequalities in the invitation and uptake of health services when remote outpatient care is offered.

Outcome selection for tissue-agnostic drug trials for immune-mediated inflammatory diseases: a systematic review of core outcome sets and regulatory guidance.

Background: Tissue-agnostic drug development provides a paradigm shift in precision medicine and requires innovative trial designs. However, outcome selection for such trials can prove challenging. The objectives of this review were to: (i) Identify and map core outcome sets (COS), across 11 immune-mediated inflammatory diseases (IMIDs) in order to facilitate the selection of relevant outcomes across the conditions for innovative trials of tissue-agnostic drug therapies.

International perspectives on suboptimal patient-reported outcome trial design and reporting in cancer clinical trials: A qualitative study.

Purpose: Evidence suggests that the patient-reported outcome (PRO) content of cancer trial protocols is frequently inadequate and non-reporting of PRO findings is widespread. This qualitative study examined the factors influencing suboptimal PRO protocol content, implementation, and reporting, and use of PRO data during clinical interactions.

Methods: Semi-structured interviews were conducted with four stakeholder groups: (1) trialists and chief investigators; (2) people with lived experience of cancer; (3) international experts in PRO cancer trial design; (4) journal editors, funding panelists, and regulatory agencies.

'Give Us The Tools!': development of knowledge transfer tools to support the involvement of patient partners in the development of clinical trial protocols with patient-reported outcomes (PROs), in accordance with SPIRIT-PRO Extension.

Objectives: (a) To adapt the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT)-patient-reported outcome (PRO) Extension guidance to a user-friendly format for patient partners and (b) to codesign a web-based tool to support the dissemination and uptake of the SPIRIT-PRO Extension by patient partners.

Design: A 1-day patient and public involvement session.

Participants: Seven patient partners.

Development of a core outcome set for use in community-based bipolar trials-A qualitative study and modified Delphi.

Background: A core outcome set (COS) is a standardised collection of outcomes to be collected and reported in all trials within a research area. A COS can reduce reporting bias and facilitate evidence synthesis. This is currently unavailable for use in community-based bipolar trials.

A Factorial Survey Investigating the Effect of Disclosing Parental Intellectual Disability on Risk Assessments by Children's Social Workers in Child Safeguarding Scenarios.

Literature suggests that, as parents, people with intellectual disabilities experience disproportionately high rates of child removal compared to other groups. A factorial survey of 191 children's social workers investigated the effect of disclosing parental intellectual disability (ID) upon risk assessments in a range of hypothetical child safeguarding scenarios. The case scenarios depicted a range of child safeguarding situations and parents' ID status was randomly included as an additional item of information.

Care providers' and patients' attitudes toward using electronic-patient reported outcomes to support patients with traumatic brain injury: a qualitative study (PRiORiTy).

To (a) identify residual symptoms and deficits resulting from a traumatic brain injury (TBI) and impact on patients' and their families' quality of life; (b) explore views and experience of care providers, researchers, patients, and carers of using PROMs; and (c) explore their attitudes toward reporting symptoms and impacts on an electronic platform. Methods: Qualitative semi-structured interviews with people with TBI and their carers; health-care professionals, researchers, and third sector staff members working with people with TBI. Results: Symptoms and long-term impacts of TBI included cognitive problems, difficulties functioning, anxiety, and depression.

Systematic Evaluation of Patient-Reported Outcome Protocol Content and Reporting in Cancer Trials.

Background: Patient-reported outcomes (PROs) are captured within cancer trials to help future patients and their clinicians make more informed treatment decisions. However, variability in standards of PRO trial design and reporting threaten the validity of these endpoints for application in clinical practice.

Methods: We systematically investigated a cohort of randomized controlled cancer trials that included a primary or secondary PRO.

Electronic patient reported outcomes to support care of patients with traumatic brain injury: PRiORiTy study qualitative protocol.

Introduction: Traumatic brain injury (TBI) represents a major health and socioeconomic problem internationally. The expansive nature of injuries results in a heterogeneous population. The degree and type of long-term impacts following TBI and improvement following injury are highly variable.