Recommendations on recording harms in randomised controlled trials of behaviour change interventions.

Harms are possible from behaviour change interventions, such as the worsening of a health behaviour intended for change (rebound effect), improving a health behaviour but with subsequent worsening of another behaviour (risk compensation), and participants feeling targeted or stigmatised by an intervention. The processes and definitions originally designed to record harms within drug trials are typically followed to record harms in trials of behaviour change interventions owing to the lack of alternative guidance. Therefore, important harms could be missed in the evaluations of behaviour change interventions or irrelevant harms data may be recorded, leading to inefficiency.

Inequalities in access to and outcomes of cardiac surgery in England: retrospective analysis of Hospital Episode Statistics (2010-2019).

Background: We aimed to characterise the variation in access to and outcomes of cardiac surgery for people in England.

Methods: We included people >18 years of age with hospital admission for ischaemic heart disease (IHD) and heart valve disease (HVD) between 2010 and 2019. Within these populations, we identified people who had coronary artery bypass graft (CABG) and/or valve surgery, respectively.

Effectiveness and cost-effectiveness of a sustainable obesity prevention programme for preschool children delivered at scale 'HENRY' (Health, Exercise, Nutrition for the Really Young): protocol for the HENRY III cluster randomised controlled trial.

Introduction: One-fifth of children start school already overweight or living with obesity, with rates disproportionately impacting those living in the most deprived areas. Social, environmental and biological factors contribute to excess weight gain and programmes delivered in early years settings aim to support families to navigate these in order to prevent obesity. One of these programmes (Health, Exercise and Nutrition for the Really Young, HENRY) has been delivered in UK community venues (hereon named 'centres') in high deprivation areas since 2008 and aims to help families to provide a healthy start for their preschool children.

Supporting people with Motor Neuron Disease (MND) to make decisions about gastrostomy feeding tube placement: a survey of UK healthcare professionals' practice and beliefs.

Objective: Understand the practice and beliefs of healthcare professionals (HCPs) supporting the decision-making of people with MND (pwMND) about gastrostomy placement, including identifying differences between professions.

Methods: An online cross-sectional survey disseminated to HCPs who support the decision-making of pwMND about gastrostomy placement.

Results: A total of 139 participants completed the survey including representation from a range of healthcare professions.

Recording harms in randomized controlled trials of behavior change interventions: a scoping review and map of the evidence.

Objectives: Randomized controlled trials evaluate diverse interventions. This can include medical interventions such as drugs or surgical procedures, or behavior change interventions (BCIs) that aim to change a habit, belief, or attitude to improve health, for example, healthy eating, psychological wellbeing. Harms are often recorded poorly or inconsistently within randomized controlled trials of BCIs.

Outpatient paracentesis for the management of ovarian hyperstimulation syndrome: study protocol for the STOP-OHSS randomised controlled trial.

Introduction: Ovarian hyperstimulation syndrome (OHSS) is the most significant short-term complication of pharmacological ovarian stimulation. Symptoms range from mild abdominal discomfort to rare complications such as renal failure, thromboembolism and respiratory distress syndrome.Currently, clinical practice typically involves monitoring the patient until the condition becomes severe, at which point they are admitted to hospital, where drainage of ascitic fluid (paracentesis) may take place.

Factors influencing decisions people with motor neuron disease make about gastrostomy placement and ventilation: A qualitative evidence synthesis.

Background: People with motor neuron disease (pwMND) are routinely offered gastrostomy feeding tube placement and (non-invasive and invasive) ventilation to manage the functional decline associated with the disease. This study aimed to synthesise the findings from the qualitative literature to understand how individual, clinical team and organisational factors influence pwMND decisions about these interventions.

Methods: The study design was guided by the enhancing transparency in reporting the synthesis of qualitative research (ENTREC) statement.

Managing ovarian hyperstimulation syndrome: A qualitative interview study with women and healthcare professionals.

Aim: To explore the experiences of women who have had ovarian hyperstimulation syndrome, and healthcare professionals who care for them.

Background: Ovarian hyperstimulation syndrome is a side effect of fertility treatment. Little research exists internationally that explores the experiences of women who have had this condition, or the healthcare professionals who manage it.

The role of socioeconomic deprivation in explaining neighborhood and clinic effects in the effectiveness of psychological interventions.

Objective: Treatment outcomes are known to vary according to therapist and clinic/organization (therapist effect, clinic effect). Outcomes may also vary according to the neighborhood where a person lives (neighborhood effect), but this has not previously been formally quantified. Evidence suggests that deprivation may contribute to explaining such cluster effects.

Using co-production to implement patient reported outcome measures in third sector organisations: a mixed methods study.

Background: Third sector organisations such as charities and community groups are using Patient Reported Outcome Measures (PROMs) at an aggregated service level to demonstrate their impact to commissioners to generate or retain funding. Despite this motivation, organisations can struggle with implementing PROMs. Previous studies have identified facilitators including organisations using an appropriate measure, co-producing the PROMs process with staff, and investing resources to support the use of measures.

The use of co-production, co-design and co-creation to mobilise knowledge in the management of health conditions: a systematic review.

Background: Knowledge mobilisation is a term used in healthcare research to describe the process of generating, sharing and using evidence. 'Co'approaches, such as co-production, co-design and co-creation, have been proposed as a way of overcoming the knowledge to practice gap. There is a need to understand why researchers choose to adopt these approaches, how they achieve knowledge mobilisation in the management of health conditions, and the extent to which knowledge mobilisation is accomplished.

Learning from COVID-19 related trial adaptations to inform efficient trial design-a sequential mixed methods study.

Background: Many clinical trial procedures were often undertaken in-person prior to the COVID-19 pandemic, which has resulted in adaptations to these procedures to enable trials to continue. The aim of this study was to understand whether the adaptations made to clinical trials by UK Clinical Trials Units (CTUs) during the pandemic have the potential to improve the efficiency of trials post-pandemic.

Methods: This was a mixed methods study, initially involving an online survey administered to all registered UK CTUs to identify studies that had made adaptations due to the pandemic.

Objective Nebuliser Adherence Data as "Proof" of Adherence in the Management of Cystic Fibrosis: A Qualitative Interview Study.

Purpose: Low adherence to medication via nebulisers is linked to poor clinical outcomes for people with Cystic Fibrosis (PWCF). Advances in technology allow electronic monitoring of nebuliser usage and feedback of objective adherence data to PWCF and clinical teams caring for them. CFHealthHub is a new intervention that collects and displays objective adherence data in easy-to-read formats with the aim of improving nebuliser adherence and health.

Tendency to call an ambulance or attend an emergency department for minor or non-urgent problems: a vignette-based population survey in Britain.

Background: There are concerns about high levels of demand for emergency health services. The aim was to identify the characteristics of the British population with a tendency to contact emergency medical services and EDs for minor or non-urgent problems.

Methods: A survey of the British adult population in 2018.

Socioeconomic Deprivation and Dropout from Contemporary Psychological Intervention for Common Mental Disorders: A Systematic Review.

Dropout during psychological intervention is a significant problem. Previous evidence for associations with socioeconomic deprivation is mixed. This study aimed to review the evidence for associations between deprivation and dropout from contemporary adult psychological interventions for common mental disorders (CMDs).

Self-management intervention to reduce pulmonary exacerbations by supporting treatment adherence in adults with cystic fibrosis: a randomised controlled trial.

Introduction: Recurrent pulmonary exacerbations lead to progressive lung damage in cystic fibrosis (CF). Inhaled medications (mucoactive agents and antibiotics) help prevent exacerbations, but objectively measured adherence is low. We investigated whether a multi-component (complex) self-management intervention to support adherence would reduce exacerbation rates over 12 months.

Constellations of pain: a qualitative study of the complexity of women's endometriosis-related pain.

Introduction: Prior research into endometriosis-related pain has focused on specific aspects of the pain experience such as cyclical pain, emotional aspects of pain and certain types of pain such as dysmenorrhea and dyspareunia. However, research has paid less attention to the diversity and complexity of women's pain experiences, which can lead to failure to recognise some symptoms as part of endometriosis and poor symptom management.

Methods: We conducted qualitative semi-structured face-to-face interviews with 20 women in the United Kingdom recruited from an endometriosis self-help group with a diagnosis of endometriosis via laparoscopy.

Adapting interventions to new contexts-the ADAPT guidance.

Implementing interventions with a previous evidence base in new contexts might be more efficient than developing new interventions for each context. Although some interventions transfer well, effectiveness and implementation often depend on the context. Achieving a good fit between intervention and context then requires careful and systematic adaptation.

Understanding young adults' reasons for seeking 'clinically unnecessary' urgent and emergency care: A qualitative interview study.

Background: Studies have identified young adults as more likely to use emergency departments for 'clinically unnecessary' problems, with limited similar evidence for emergency ambulance use. Media portrayals depict young adults as motivated by 'convenience', but little research has explored the reasons for their help-seeking behaviour.

Methods: Qualitative interviews with 16 young adults (18-30) considered by clinicians to have made unnecessary use of emergency ambulance, emergency department or an urgent GP appointment.

Health literacy levels of British adults: a cross-sectional survey using two domains of the Health Literacy Questionnaire (HLQ).

Background: A person's health literacy determines whether they are able to make appropriate health decisions and are able to follow treatment instructions. This is important because low health literacy is associated with mortality and extra costs to the healthcare system. Our aim was to describe the health literacy levels of British adults using a nationally representative population survey, and show how health literacy levels vary by population characteristics.

Feasibility study for supporting medication adherence for adults with cystic fibrosis: mixed-methods process evaluation.

Objectives: To undertake a process evaluation of an adherence support intervention for people with cystic fibrosis (PWCF), to assess its feasibility and acceptability.

Setting: Two UK cystic fibrosis (CF) units.

Participants: Fourteen adult PWCF; three professionals delivering adherence support ('interventionists'); five multi-disciplinary CF team members.

How do third sector organisations or charities providing health and well-being services in England implement patient-reported outcome measures (PROMs)? A qualitative interview study.

Objectives: To identify the facilitators and barriers to implementing patient-reported outcome measures (PROMs) in third sector organisations (TSOs) delivering health and well-being services.

Design: A qualitative interview study. Participants were recruited using purposive, opportunistic and snowballing methods.

Mechanisms of Action of a Web-Based Intervention With Health Professional Support to Increase Adherence to Nebulizer Treatments in Adults With Cystic Fibrosis: Qualitative Interview Study.

Background: Adherence to nebulizer treatments in adults with cystic fibrosis (CF) is often low. A new complex intervention to help adults with CF increase their adherence to nebulizer treatments was tested in a pilot randomized controlled trial (RCT) in 2 UK CF centers. Patients used a nebulizer with electronic monitoring capabilities that transferred data automatically to a digital platform (CFHealthHub) to monitor adherence over time and to a tailored website to display graphs of adherence data and educational and problem-solving information about adherence.