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. We aim to establish the effectiveness and cost-effectiveness of HENRY, including its potential role from a wider systems perspective. METHODS AND ANALYSIS: This is a multicentre, open-labelled, two-group, prospective, cluster randomised controlled trial, with cost-effectiveness analysis, systems-based process evaluation and internal pilot. Primary analysis will compare body mass index (BMI) z-score at 12 months in children (n=984) whose parents have attended HENRY to those who have not attended. Secondary outcomes include parent and staff BMI and waist circumference, parenting efficacy, feeding, eating habits, quality of life, resource use and medium term (3 years) BMI z-scores (child and siblings). 82 centres in ~14 local authority areas will be randomised (1:1) to receive HENRY or continue with standard practice. Intention-to-treat analysis will compare outcomes using mixed effects linear regression. Economic evaluation will estimate a within-trial calculation of cost-per unit change in BMI z-score and longer-term trajectories to determine lifelong cost savings (long-term outcomes). A systems process evaluation will explore whether (and how) implementation of HENRY impacts (and is impacted by) the early years obesity system. An established parent advisory group will support delivery and dissemination. ETHICS AND DISSEMINATION: Ethical approval has been granted by the University of York, Health Sciences' Research Governance Committee (HSRGC/2022/537/E). Dissemination includes policy reports, community resources, social media and academic outputs. TRIAL REGISTRATION NUMBER: ISRCTN16529380.

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. A third (36/101, 36%) initiated discussions about gastrostomy later in practice than they believed was ideal. In relation to the outcome of declining compared to accepting gastrostomy, participants were more likely to discuss aspiration (80% vs. 68%), choking (76% vs. 58%) and prognosis (36% vs. 22%). Participants believed gastrostomies should be placed after a mean 8.1% weight loss since symptom-onset. More participants favored gastrostomy placement before pwMND presented with respiratory symptoms (45%) compared to onset of dysphagia (11%). Half believed pwMND placed gastrostomies too late. Participants were more likely to 'often'/'always' recommend pwMND to have a gastrostomy (23%) than continue without (7%) or decline (4%) gastrostomy, when believing these were the best option for pwMND. Nurses and dietitians discussed the broadest range of information, while doctors were more likely to discuss mortality risk and prognosis. CONCLUSION: There is variation in HCPs practice and beliefs about initiating discussions, the sharing of information and recommendations, and timing, about gastrostomy placement. The information shared varies by profession and there is evidence of sub-optimal communication between HCPs. Further research is required to understand how these findings may impact on the decision-making of pwMND about gastrostomy.

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. This scoping review aimed to collate and describe literature on categories, definitions, and mechanisms of harms from BCIs; methods of identifying plausible harms; and recommendations for recording harms. STUDY DESIGN AND SETTING: A scoping review was conducted. Three databases (MEDLINE, PsycINFO, and CINAHL) were searched. Reference list checking and citation searching were performed. Articles were included if they discussed (1) interventions that aimed to modify behavior, (2) categories or mechanisms of harms, and (3) methods or recommendations for recording harms. All research designs were included. One reviewer reviewed titles, abstracts, and full texts; queries were checked with another reviewer. Data were extracted and synthesized descriptively by one reviewer and checked by another reviewer. A thematic map was constructed to summarize the review findings. Harms described from specific BCIs were identified, and examples were selected and summarized. RESULTS: The review included 37 articles. Nineteen of 37 articles contributed to a thematic review. Three articles described categories of harms; categories of harm included physical, psychological, group and social interactions, cultural, equity, opportunity cost, environmental, and economic. Seven articles included mechanisms or underlying factors for harms including feelings of failure leading to shame or stigma, and group interventions enabling knowledge exchange on unhealthy behaviors. Twelve articles provided recommendations for recording harms, including taking a proportionate approach by focusing on the most plausible and important harms, collecting different perspectives on whether harms had occurred (eg, caregivers and family members), and using qualitative research methods to identify harms. One article described a three-step method to identify plausible harms from an intervention, and six articles supported aspects of the method. Eighteen of 37 articles contributed to a review which collated harms arising from specific interventions, for example, a peer support intervention in inflammatory bowel disease caused distressing conversations which might lead to anxiety and confrontation with a possible negative future. CONCLUSION: BCIs can cause harm. This review identified categories and proposed mechanisms of harms, as well as methods and recommendations for identifying and recording harms in BCIs for inclusion in forthcoming recommendations.

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. Preliminary studies have indicated that earlier outpatient paracentesis may reduce the progression of OHSS and prevent hospitalisation in women. METHODS AND ANALYSIS: This UK, multicentre, pragmatic, two-arm, parallel-group, adaptive (group sequential with one interim analysis), open-label, superiority, confirmatory, group sequential, individually randomised controlled trial, with internal pilot will assess the clinical and cost-effectiveness and safety of outpatient paracentesis versus conservative management (usual care) for moderate or severe OHSS. 224 women from 20 National Health Service and private fertility units will be randomised (1:1) and followed up for up to 13.5 months. The primary outcome is the rate of OHSS related hospital admission of at least 24 hours within 28 days postrandomisation. The primary analysis will be an intention to treat with difference in hospitalisation rates as measure of treatment effect. Secondary outcomes include time to resolution of symptoms, patient satisfaction, adverse events and cost-effectiveness. A qualitative substudy will facilitate the feasibility of recruitment. Participant recruitment commenced in June 2022. ETHICS AND DISSEMINATION: London-Southeast Research Ethics Committee approved the protocol (reference: 22/LO/0015). Findings will be submitted to peer-reviewed journals and abstracts to relevant national and international conferences, as well as being disseminated to trial participants and patient groups. TRIAL REGISTRATION NUMBER: ISRCTN71978064.

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. The search of five bibliography databases and an extensive supplementary search strategy identified 27 papers that included qualitative accounts of pwMND, caregivers and healthcare professionals' (HCPs) experiences of making decisions about gastrostomy and ventilation. The findings from each study were included in a thematic synthesis. FINDINGS: Making decisions about interventions is an emotional rather than simply a functional issue for pwMND. The interventions can signal an end to normality, and increasing dependence, where pwMND consider the balance between quality of life and extending survival. Interactions with multiple HCPs and caregivers can influence the process of decision-making and the decisions made. These interactions contribute to the autonomy pwMND are able to exert during decision-making. HCPs can both promote and threaten pwMND perceived agency over decisions through how they approach discussions about these interventions. Though there is uncertainty over the timing of interventions, pwMND who agree to interventions report reaching a tipping point where they accept the need for change. CONCLUSION: Discussion of gastrostomy and ventilation options generate an emotional response in pwMND. Decisions are the consequence of interactions with multiple external agents, including HCPs treading a complex ethical path when trying to improve health outcomes while respecting pwMND right to autonomy. Future decision support interventions that address the emotional response and seek to support autonomy have the potential to enable pwMND to make informed and timely decisions about gastrostomy placement and ventilation. PATIENT OR PUBLIC CONTRIBUTION: The lead author collaborated with several patient and participant involvement (PPI) groups with regards to the conceptualisation and design of this project. Decisions that have been influenced by discussions with multiple PPI panels include widening the scope of decisions about ventilation in addition to gastrostomy placement and the perceptions of all stakeholders involved (i.e., pwMND, caregivers and HCPs).

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. DESIGN: Qualitative study using semi-structured interviews. METHODS: Eighteen interviews with women who had experienced ovarian hyperstimulation syndrome (n = 10) and healthcare professionals (n = 8) in six UK fertility centres. Framework analysis was used. This paper is reported following COREQ guidelines. RESULTS: Women described a range of symptoms and severity, sometimes experiencing worrying physical health problems such as abdominal swelling and shortness of breath. The combination of the symptoms, and their management, on delaying future fertility treatment could cause emotional distress. Healthcare professionals at different centres described variation in practice, which generally involved 'active monitoring' until symptoms became severe, when women would be hospitalised. Women expressed feeling 'left in limbo' while waiting for symptoms to improve or worsen, and described a lack of control during this waiting period. Healthcare professionals felt they provided adequate information about ovarian hyperstimulation syndrome and its management. This, however, did not align with women's perceptions that information, including potential delays to their fertility treatment, was missing. There was similar mismatch between women's and healthcare professionals' views of decision-making about fertility treatment following ovarian hyperstimulation syndrome, including women's concerns about having to make rushed, unplanned decisions about their fertility treatment when they did not feel adequately informed to do so. CONCLUSION: Ovarian hyperstimulation syndrome and its management can have a significant physical and emotional impact on women, and influence their fertility treatment. Improvements could be made to the information women receive about this condition, its management and its implications for wider fertility treatment. IMPLICATIONS FOR THE PROFESSION AND/OR PATIENT CARE: Nurses have the skills and knowledge to support women through the physical and emotional stresses of fertility treatment. Therefore, they are well placed to provide specialist information and support for OHSS and ensure women are fully informed about all aspects of the condition, including how its management might delay fertility treatment.

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. This study aimed to (a) simultaneously quantify neighborhood, clinic, and therapist effects on intervention effectiveness and (b) determine the extent to which deprivation variables explain neighborhood and clinic effects. METHOD: The study used a retrospective, observational cohort design with a high intensity psychological intervention sample (N = 617,375), and a low intensity (LI) psychological intervention sample (N = 773,675). Samples each included 55 clinics, 9,000-10,000 therapists/practitioners, and over 18,000 neighborhoods in England. Outcomes were postintervention depression and anxiety scores and clinical recovery. Deprivation variables included individual employment status, domains of neighborhood deprivation, and clinic-level mean deprivation. Data were analyzed using cross-classified multilevel models. RESULTS: Unadjusted neighborhood effects of 1%-2% and unadjusted clinic effects of 2%-5% were detected, with proportionally larger effects for LI interventions. After controlling for predictors, adjusted neighborhood effects of 0.0%-0.1% and clinic effects of 1%-2% remained. Deprivation variables were able to explain a significant proportion of the neighborhood effect (80%-90% of neighborhood variance) but not clinic effect. The majority of neighborhood variance could only be explained by a shared effect of baseline severity and socioeconomic deprivation variables. CONCLUSIONS: People in different neighborhoods respond differently to psychological intervention, and this clustering effect was mainly explained by socioeconomic factors. People also respond differently according to the clinic they access, but this could not be completely explained by deprivation in the present study. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

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. METHODS: Studies that explicitly used the terms co-production, co-design or co-creation to mobilise knowledge in the management of health conditions were included. Web of Science, EMBASE via OvidSP, MEDLINE via OvidSP and CINHAL via EBSCO databases were searched up to April 2021. Quality assessment was carried out using the Joanna Briggs Institute qualitative quality assessment checklist. Pluye and Hong's seven steps for mixed studies reviews were followed. Data were synthesised using thematic synthesis. RESULTS: Twenty four international studies were included. These were qualitative studies, case studies and study protocols. Key aspects of 'co'approaches were bringing people together as active and equal partners, valuing all types of knowledge, using creative approaches to understand and solve problems, and using iterative prototyping techniques. Authors articulated mechanisms of action that included developing a shared understanding, identifying and meeting needs, giving everyone a voice and sense of ownership, and creating trust and confidence. They believed these mechanisms could produce interventions that were relevant and acceptable to stakeholders, more useable and more likely to be implemented in healthcare. Varied activities were used to promote these mechanisms such as interviews and creative workshops. There appeared to be a lack of robust evaluation of the interventions produced so little evidence in this review that 'co'approaches improved the management of health conditions. CONCLUSION: Those using 'co'approaches believed that they could achieve knowledge mobilisation through a number of mechanisms, but there was no evidence that these led to improved health. The framework of key aspects and mechanisms of 'co'approaches developed here may help researchers to meet the principles of these approaches. There is a need for robust evaluation to identify whether 'co'approaches produce improved health outcomes. TRIAL REGISTRATION: PROSPERO CRD42020187463 .

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. However, to date no studies have applied this learning to third sector organisations to evaluate whether taking an evidence-informed implementation approach improves the use of PROMs. METHODS: A Community-Based Participatory Research approach was used which involved university-based researchers supporting two third sector organisations to implement PROMs. The researchers provided evidence-informed advice and training. The organisations were responsible for implementing PROMs. The researchers evaluated implementation through a mixed methods approach including five key informant interviews, four evaluation groups and analysis of collected PROMs data (n = 313). RESULTS: Both third sector organisations faced considerable constraints in incorporating known facilitators and addressing barriers. The organisations involved staff in choosing an acceptable measure. However, competing priorities including external pressures to use specific PROMs, busy workloads and staff opinions created challenges to using measures. Investment of time and energy into developing an outcomes-based organisational culture was key to enable the prioritisation of PROMs. For example, discussing PROMs in supervision so that they were viewed as part of people's job roles. Organisations found that implementation took several years and was disrupted by other pressures. CONCLUSIONS: Whilst organisations were motivated to implement PROMs to obtain or retain funding, they faced considerable practical and ideological challenges. Consequently, some stakeholders felt that alternative methods to measuring impact could potentially be more feasible than PROMs.

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. Representatives from selected studies were qualitatively interviewed to explore the adaptations made and their potential to improve the efficiency of future trials. A literature review was undertaken to locate published evidence concerning the investigated adaptations. The findings from the interviews were reviewed by a group of CTU and patient representatives within a workshop, where discussions focused on the potential of the adaptations to improve the efficiency of future trials. RESULTS: Forty studies were identified by the survey. Fourteen studies were selected and fifteen CTU staff were interviewed about the adaptations. The workshop included 15 CTU and 3 patient representatives. Adaptations were not seen as leading to direct efficiency savings for CTUs. However, three adaptations may have the potential to directly improve efficiencies for trial sites and participants beyond the pandemic: a split remote-first eligibility assessment, recruitment outside the NHS via a charity, and remote consent. There was a lack of published evidence to support the former two adaptations, however, remote consent is widely supported in the literature. Other identified adaptations may benefit by improving flexibility for the participant. Barriers to using these adaptations include the impact on scientific validity, limitations in the role of the CTU, and participant's access to technology. CONCLUSIONS: Three adaptations (a split remote-first eligibility assessment, recruitment outside the NHS via a charity, and remote consent) have the potential to improve clinical trials but only one (remote consent) is supported by evidence. These adaptations could be tested in future co-ordinated 'studies within a trial' (SWAT).

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. There is little understanding of how objective adherence data is perceived by PWCF and healthcare professionals (HCPs). Patients and Methods: A qualitative study using semi-structured interviews with 22 PWCF and 31 HCPs who had used the CFHealthHub intervention. Results: Objective adherence data was welcomed by the majority of PWCF in the sample, and HCP delivering the intervention, because the data allowed PWCF to reflect on patterns of adherence or non-adherence. Ease of use and characteristics of data display were important, particularly the use of a "traffic light" system to allow PWCF to easily see if they were meeting their adherence targets. For PWCF objective adherence data was used as "proof to self", offering reassurance to high adherers, and a wake-up call to those with lower levels of adherence. It could also provide 'proof to others' where PWCF had higher levels of adherence than HCP or family members believed. The data could sometimes change HCP perceptions of PWCF's identities as poor adherers. Where adherence was not high, data was used to facilitate honest discussions between PWCF and HCPs about how to increase adherence. HCPs perceived that it was important to use the data positively to motivate, rather than criticise, PWCF. Conclusion: Objective nebuliser adherence data in CFHealthHub can offer proof of adherence to PWCF and HCPs. It is important to use it constructively to facilitate discussions on how to improve adherence.

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. Six vignettes were constructed about illness in adults (cough/sore throat or diarrhoea/vomiting), injury in adults (sore rib or back pain) and fever in children (occurring weekday or weekend). RESULTS: The response rate was 42%, with 2906 respondents. 11% (319/2716) of respondents selected to contact an ambulance and 43% ED, mainly for the vignettes about fever in children and sore rib. Males, people from ethnic minority communities and older people had a tendency to contact emergency services for minor problems. Tendency to call an ambulance was also characterised by 'low resources' (manual or unskilled occupations, no car, low health literacy), worry that a symptom might be serious, distress (feeling overwhelmed by health problems) and frequent use of EDs. For EDs, there was an attraction to EDs because of availability of tests. CONCLUSION: Whereas use of emergency ambulances for minor or non-urgent problems appeared to be driven by people's lack of resources, including lack of transport, use of EDs appeared to be driven by their attractive characteristic of offering tests quickly.

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. METHODS: Between October 2017 and May 2018, adults with CF (aged ≥16 years; 19 UK centres) were randomised to the intervention (data-logging nebulisers, a digital platform and behavioural change sessions with trained clinical interventionists) or usual care (data-logging nebulisers). Outcomes included pulmonary exacerbations (primary outcome), objectively measured adherence, body mass index (BMI), lung function (FEV1) and Cystic Fibrosis Questionnaire-Revised (CFQ-R). Analyses were by intent to treat over 12 months. RESULTS: Among intervention (n=304) and usual care (n=303) participants (51% female, median age 31 years), 88% completed 12-month follow-up. Mean exacerbation rate was 1.63/year with intervention and 1.77/year with usual care (adjusted ratio 0.96; 95% CI 0.83 to 1.12; p=0.64). Adjusted mean differences (95% CI) were in favour of the intervention versus usual care for objectively measured adherence (9.5% (8.6% to 10.4%)) and BMI (0.3 (0.1 to 0.6) kg/m2), with no difference for %FEV1 (1.4 (-0.2 to 3.0)). Seven CFQ-R subscales showed no between-group difference, but treatment burden reduced for the intervention (3.9 (1.2 to 6.7) points). No intervention-related serious adverse events occurred. CONCLUSIONS: While pulmonary exacerbations and FEV1 did not show statistically significant differences, the intervention achieved higher objectively measured adherence versus usual care. The adherence difference might be inadequate to influence exacerbations, though higher BMI and lower perceived CF treatment burden were observed.

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). Systematic review, narrative synthesis and random effects meta-analysis of peer-reviewed English language journal articles published June 2010-June 2020 was conducted. Data sources included medline, PsycInfo, databases indexed by web of science, ProQuest social science database and sociology collection, and the Cochrane Library, supplemented by forward and backward citation searching. Five studies were eligible for inclusion (mean N = 170, 68% female, 60% White Caucasian, 32% dropout rate, predominantly cognitive behaviour therapy/cognitive processing therapy). Narrative synthesis indicated an overall non-significant effect of deprivation on dropout. Meta-analytic significance of controlled (k = 3) and uncontrolled (k = 4) effects depended on the measure of deprivation included for those studies using more than one measure (controlled OR 1.21-1.32, p = 0.019-0.172, uncontrolled OR 1.28-1.76, p = 0.024-0.423). The low number of included studies meant sub-group comparisons were limited, despite some tentative indications of potential differential effects. A comparator set of excluded studies showed similar uncertainty. There was limited evidence that did not overall suggest a clear significant effect of deprivation on dropout from contemporary individual CMD interventions. However, more contemporary research is needed, as effects may vary according to clinical and methodological factors, and for dropout versus non-initiation.

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. A topic guide framed questions around experiences of pain. Interviews were audio-recorded and transcribed verbatim. Transcripts were analysed using inductive thematic analysis. RESULTS: Women experienced multiple types of pain that they felt were caused by endometriosis and affected many different parts of the body including bowel, bladder, lungs, kidneys, nerves, upper body, lower limbs and head. These pains consisted of different conceptual categories: type, pattern and intensity. These categories came together to create a complex, interrelated experience for each individual that we termed 'constellations of pain' because each woman had a complex set of pain categories and no two individuals appeared to have the same pain experience. CONCLUSION: The complexity and diversity of endometriosis-related pain found in this study has implications for improving diagnosis, medical and non-medical pain management and improving the clinical encounter between women and healthcare professionals.

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. Data analysis was informed by interpretive phenomenological analysis. FINDINGS: A number of interrelated factors contributed to participants' decisions. They were anxious about the seriousness of their symptoms, sometimes exacerbated by reduced coping capacity due to poor mental health or life stresses. They looked to others to facilitate their decision making, who sometimes encouraged urgent contact. They wanted to avoid impact on existing day-to-day commitments including work or study. They had strong views about different health services, sometimes based on frustration with lack of resolution of on-going health problems. Convenience was not identified as a significant factor, although some actions could be interpreted in this light if the context was not considered. CONCLUSIONS: Young adults make 'clinically unnecessary' use of urgent and emergency care for more than convenience. Their decisions need to be understood in relation to the complexity of their experience, including lack of confidence in making health-related decisions, lowered coping capacity and concern to maintain normal daily life.

Influences of Extended Family on Intimate Partner Violence: Perceptions of Pakistanis in Pakistan and the United Kingdom.

Limited research has been undertaken on the role of extended family members in Intimate Partner Violence (IPV). This study uniquely explores the perspective of Pakistani men and women about the role of a husband and wife's families in relation to marital conflict and IPV. For this qualitative study, data were collected through 41 individual interviews, including 20 from Pakistan and 21 from the United Kingdom. The findings are presented in four themes, including "privacy and personal space," "interference and instigation of problems," "conflicting and uncommunicated expectations," and "adjustment facilitation." A lack of privacy and personal space within a family home shared with extended family on the husband's side, interference in terms of mothers-in-law and sisters-in-law making complaints about the wife, and the couple's differing expectations of the husband's responsibility for his extended family could cause tension and conflict that could lead to IPV. The husband's family could also have a positive effect by minimizing conflict through offering the couple personal time and helping the wife to adjust to her new family. The wife's family was perceived as having a much more passive role in terms of not interfering, but instead allowing her to adjust to her new extended family. In conclusion, the husband's extended family can have a considerable impact on conflict within couples. Public health prevention initiatives for IPV in Pakistani people should address the role of the husband's extended family. The findings of the study are not only important for the population studied, which is part of an international diaspora, but also for other communities worldwide that value close family structure due to cultural and religious preferences.

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. METHODS: A population based cross-sectional survey including questions from two domains from the Health Literacy Questionnaire™: 1) Understanding health information well enough to know what to do, and 2) Ability to actively engage with health care providers. Both domains are made up of 5 Likert style questions with 5 levels ranging from 'cannot do or always difficult' (1) to 'always easy' (5). The survey was conducted by NatCen in Britain (2018) as part of the annual British Social Attitudes survey. We used weighted descriptive analyses and regression to explore the relationship between population characteristics and health literacy. Weighted analyses were used to ensure the sample was representative of the British population. RESULTS: A total of 2309 responded to the questionnaire. The mean score for 'understanding information' was 3.98 (95% CI: 3.94, 4.02) and for 'ability to engage' was 3.83 (95% CI: 3.80, 3.87), where 5 is the highest score. 19.4% had some level of difficulty reading and understanding written health information, and 23.2% discussing health concerns with health care providers. The adjusted logistic regression for 'understanding information' showed that those with lower health literacy were more likely to be in the most socially deprived quintile (OR 2.500 95% CI: 1.180, 5.296), have a limiting health condition or disability (OR 4.326 95% CI: 2.494, 7.704), and have no educational qualifications (OR 7.588 95% CI: 3.305, 17.422). This was similar for the 'ability to engage' domain. CONCLUSIONS: This study described the distribution of health literacy levels for the British population in 2018. Interventions to improve health literacy will best be targeted at those with lower levels of education, those living in the most deprived areas, and those with a limiting health condition or disability.

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. Framework analysis was used. SETTING: TSOs including charities, community groups and not-for-profit organisations in England, UK. PARTICIPANTS: Thirty interviewees including service users, TSO front-line workers and managers, commissioners of TSOs and other stakeholders such as academic researchers. RESULTS: TSOs primarily used PROMs because of pressures arising from the external funding context. However, organisations often struggled to implement PROMs, rarely getting the process right first time. Facilitators for implementation included having an implementation lead committed to making it work, investing resources in data management systems and support staff and taking a collaborative approach to designing the PROMs process. The latter helped to ensure an appropriate PROMs process for the specific TSO including choosing a suitable measure and planning how data would be collected, processed and used. There was a dilemma about whether TSOs should use standardised well-being measures (eg, the Warwick-Edinburgh Mental Well-being Scale) or design their own PROM. Not all TSOs sustained the collection and reporting of PROMs over time because this required a change in organisational culture to view PROMs as beneficial for the TSO and PROMs becoming part of front-line workers' job specifications. CONCLUSIONS: TSOs are trying to use PROMs because they feel they have no choice but often struggle with implementation. Having an implementation lead, designing an appropriate process, investing resources, training staff and taking mitigating action to address potential barriers can facilitate implementation. Some of the findings are consistent with the experiences of more clinical services so appear relevant to the implementation of PROMs irrespective of the specific context.