Understanding the causes of missingness in primary care: a realist review.

BACKGROUND: Although missed appointments in healthcare have been an area of concern for policy, practice and research, the primary focus has been on reducing single 'situational' missed appointments to the benefit of services. Little attention has been paid to the causes and consequences of more 'enduring' multiple missed appointments in primary care and the role this has in producing health inequalities. METHODS: We conducted a realist review of the literature on multiple missed appointments to identify the causes of 'missingness.' We searched multiple databases, carried out iterative citation-tracking on key papers on the topic of missed appointments and identified papers through searches of grey literature. We synthesised evidence from 197 papers, drawing on the theoretical frameworks of candidacy and fundamental causation. RESULTS: Missingness is caused by an overlapping set of complex factors, including patients not identifying a need for an appointment or feeling it is 'for them'; appointments as sites of poor communication, power imbalance and relational threat; patients being exposed to competing demands, priorities and urgencies; issues of travel and mobility; and an absence of choice or flexibility in when, where and with whom appointments take place. CONCLUSIONS: Interventions to address missingness at policy and practice levels should be theoretically informed, tailored to patients experiencing missingness and their identified needs and barriers; be cognisant of causal domains at multiple levels and address as many as practical; and be designed to increase safety for those seeking care.

Adolescents' interactive electronic device use, sleep and mental health: a systematic review of prospective studies.

Optimal sleep, both in terms of duration and quality, is important for adolescent health. However, young people's sleeping habits have worsened over recent years. Access to and use of interactive electronic devices (e.g., smartphones, tablets, portable gaming devices) and social media have become deep-rooted elements of adolescents' lives and are associated with poor sleep. Additionally, there is evidence of increases in poor mental health and well-being disorders in adolescents; further linked to poor sleep. This review aimed to summarise the longitudinal and experimental evidence of the impact of device use on adolescents' sleep and subsequent mental health. Nine electronic bibliographical databases were searched for this narrative systematic review in October 2022. Of 5779 identified unique records, 28 studies were selected for inclusion. A total of 26 studies examined the direct link between device use and sleep outcomes, and four reported the indirect link between device use and mental health, with sleep as a mediator. The methodological quality of the studies was generally poor. Results demonstrated that adverse implications of device use (i.e., overuse, problematic use, telepressure, and cyber-victimisation) impacted sleep quality and duration; however, relationships with other types of device use were unclear. A small but consistent body of evidence showed sleep mediates the relationship between device use and mental health and well-being in adolescents. Increasing our understanding of the complexities of device use, sleep, and mental health in adolescents are important contributions to the development of future interventions and guidelines to prevent or increase resilience to cyber-bullying and ensure adequate sleep.

Social network interventions to support cardiac rehabilitation and secondary prevention in the management of people with heart disease.

BACKGROUND: Globally, cardiovascular diseases (CVD, that is, coronary heart (CHD) and circulatory diseases combined) contribute to 31% of all deaths, more than any other cause. In line with guidance in the UK and globally, cardiac rehabilitation programmes are widely offered to people with heart disease, and include psychosocial, educational, health behaviour change, and risk management components. Social support and social network interventions have potential to improve outcomes of these programmes, but whether and how these interventions work is poorly understood.  OBJECTIVES: To assess the effectiveness of social network and social support interventions to support cardiac rehabilitation and secondary prevention in the management of people with heart disease. The comparator was usual care with no element of social support (i.e. secondary prevention alone or with cardiac rehabilitation).  SEARCH METHODS: We undertook a systematic search of the following databases on 9 August 2022: CENTRAL, MEDLINE, Embase, and the Web of Science. We also searched ClinicalTrials.gov and the WHO ICTRP. We reviewed the reference lists of relevant systematic reviews and included primary studies, and we contacted experts to identify additional studies.  SELECTION CRITERIA: We included randomised controlled trials (RCTs) of social network or social support interventions for people with heart disease. We included studies regardless of their duration of follow-up, and included those reported as full text, published as abstract only, and unpublished data. DATA COLLECTION AND ANALYSIS: Using Covidence, two review authors independently screened all identified titles. We retrieved full-text study reports and publications marked 'included', and two review authors independently screened these, and conducted data extraction. Two authors independently assessed risk of bias, and assessed the certainty of the evidence using GRADE. Primary outcomes were all-cause mortality, cardiovascular-related mortality, all-cause hospital admission, cardiovascular-related hospital admission, and health-related quality of life (HRQoL) measured at > 12 months follow-up.  MAIN RESULTS: We included 54 RCTs (126 publications) reporting data for a total of 11,445 people with heart disease. The median follow-up was seven months and median sample size was 96 participants. Of included study participants, 6414 (56%) were male, and the mean age ranged from 48.6 to 76.3 years. Studies included heart failure (41%), mixed cardiac disease (31%), post-myocardial infarction (13%), post-revascularisation (7%), CHD (7%), and cardiac X syndrome (1%) patients. The median intervention duration was 12 weeks. We identified notable diversity in social network and social support interventions, across what was delivered, how, and by whom.  We assessed risk of bias (RoB) in primary outcomes at > 12 months follow-up as either 'low' (2/15 studies), 'some concerns' (11/15), or 'high' (2/15). 'Some concerns' or 'high' RoB resulted from insufficient detail on blinding of outcome assessors, data missingness, and absence of pre-agreed statistical analysis plans. In particular, HRQoL outcomes were at high RoB. Using the GRADE method, we assessed the certainty of evidence as low or very low across outcomes. Social network or social support interventions had no clear effect on all-cause mortality (risk ratio (RR) 0.75, 95% confidence interval (CI) 0.49 to 1.13, I2 = 40%) or cardiovascular-related mortality (RR 0.85, 95% CI 0.66 to 1.10, I2 = 0%) at > 12 months follow-up. The evidence suggests that social network or social support interventions for heart disease may result in little to no difference in all-cause hospital admission (RR 1.03, 95% CI 0.86 to 1.22, I2 = 0%), or cardiovascular-related hospital admission (RR 0.92, 95% CI 0.77 to 1.10, I2 = 16%), with a low level of certainty. The evidence was very uncertain regarding the impact of social network interventions on HRQoL at > 12 months follow-up (SF-36 physical component score: mean difference (MD) 31.53, 95% CI -28.65 to 91.71, I2 = 100%, 2 trials/comparisons, 166 participants; mental component score MD 30.62, 95% CI -33.88 to 95.13, I2 = 100%, 2 trials/comparisons, 166 participants).  Regarding secondary outcomes, there may be a decrease in both systolic and diastolic blood pressure with social network or social support interventions. There was no evidence of impact found on psychological well-being, smoking, cholesterol, myocardial infarction, revascularisation, return to work/education, social isolation or connectedness, patient satisfaction, or adverse events.  Results of meta-regression did not suggest that the intervention effect was related to risk of bias, intervention type, duration, setting, and delivery mode, population type, study location, participant age, or percentage of male participants.  AUTHORS' CONCLUSIONS: We found no strong evidence for the effectiveness of such interventions, although modest effects were identified in relation to blood pressure. While the data presented in this review are indicative of potential for positive effects, the review also highlights the lack of sufficient evidence to conclusively support such interventions for people with heart disease. Further high-quality, well-reported RCTs are required to fully explore the potential of social support interventions in this context. Future reporting of social network and social support interventions for people with heart disease needs to be significantly clearer, and more effectively theorised, in order to ascertain causal pathways and effect on outcomes.

A peer-led, school-based social network intervention for young people in the UK, promoting sexual health via social media and conversations with friends: intervention development and optimisation of STASH.

BACKGROUND: The quality of school-based sex and relationships education (SRE) is variable in the UK. Digitally-based interventions can usefully supplement teacher-delivered lessons and positively impact sexual health knowledge. Designed to address gaps in core SRE knowledge, STASH (Sexually Transmitted infections And Sexual Health) is a peer-led social network intervention adapted from the successful ASSIST (A Stop Smoking in Schools Trial) model, and based on Diffusion of Innovation theory. This paper describes how the STASH intervention was developed and refined. METHODS: Drawing on the Six Steps in Quality Intervention Development (6SQuID) framework, we tested a provisional programme theory through three iterative stages -: 1) evidence synthesis; 2) intervention co-production; and 3) adaptation - which incorporated evidence review, stakeholder consultation, and website co-development and piloting with young people, sexual health specialists, and educators. Multi-method results were analysed in a matrix of commonalities and differences. RESULTS: Over 21 months, intervention development comprised 20 activities within the three stages. 1) We identified gaps in SRE provision and online resources (e.g. around sexual consent, pleasure, digital literacy), and confirmed critical components including the core ASSIST peer nomination process, the support of schools, and alignment to the national curriculum. We reviewed candidate social media platforms, ruling out all except Facebook on basis of functionality restrictions which precluded their use for our purposes. 2) Drawing on these findings, as well as relevant behaviour change theories and core elements of the ASSIST model, we co-developed new content with young people and other stakeholders, tailored to sexual health and to delivery via closed Facebook groups, as well as face-to-face conversations. 3) A pilot in one school highlighted practical considerations, including around peer nomination, recruitment, awareness raising, and boundaries to message sharing. From this, a revised STASH intervention and programme theory were co-developed with stakeholders. CONCLUSIONS: STASH intervention development required extensive adaptation from the ASSIST model. Although labour intensive, our robust co-development approach ensured that an optimised intervention was taken forward for feasibility testing. Evidencing a rigorous approach to operationalising existing intervention development guidance, this paper also highlights the significance of balancing competing stakeholder concerns, resource availability, and an ever-changing landscape for implementation. TRIAL REGISTRATION: ISRCTN97369178.

Environmental and practice factors associated with children's device-measured physical activity and sedentary time in early childhood education and care centres: a systematic review.

BACKGROUND: Early childhood education and care (ECEC) settings offer a potentially cost-effective and sustainable solution for ensuring children have opportunities to meet physical activity (PA) and sedentary time (ST) guidelines. This paper systematically reviewed the association between childcare environment and practice and children's PA and ST. METHODS: Three electronic databases were searched, and citation tracking of eligible studies performed between June-July 2020 (updated March 2022). Studies were eligible when (i) participants attended ECEC settings, (ii) they reported the association between use of outdoor space, including factors of time, availability, play, size and equipment, and children's device-measured PA and ST, and (iii) where applicable, they compared the exposure to use of indoor space. Risk of bias was assessed using the Critical Appraisal Skills Program (CASP) tools. A synthesis was performed using effect direct plots and charts to visualise effect sizes. RESULTS: Of 1617 reports screened, 29 studies met the inclusion criteria. Studies provided data on outdoor versus indoor time (n = 9; 960 children), outdoor versus indoor play (n = 3; 1104 children), outdoor play space (n = 19; 9596 children), outdoor space use external to ECEC (n = 2; 1148 children), and portable (n = 7; 2408 children) and fixed (n = 7; 2451 children) outdoor equipment. Time spent outdoors versus indoors was associated with increased moderate-to-vigorous PA (MVPA), light PA (LPA) and total PA, while the association with ST was inconclusive. The mean (standard deviation) levels of outdoor MVPA (4.0 ± 3.2 to 18.6 ± 5.6 min/h) and LPA (9.9 ± 2.6 to 30.8 ± 11.8 min/h) were low, and ST high (30.0 ± 6.5 to 46.1 ± 4.3 min/h). MVPA levels doubled when children played outdoors versus indoors. Outdoor play space, and outdoor portable equipment, were associated with increased MVPA. A dose-response relationship for outdoor play area size was observed, demonstrating increased MVPA with areas ≥505m2 (5436 ft2), but no further increases when areas were > 900m2 (9688 ft2). No studies reported on injuries in outdoor settings. CONCLUSIONS: ECEC policies and practices should promote not only outdoor time but also the availability of resources such as portable play equipment and sufficient size of outdoor play areas that enable children to be physically active for sustained periods while outdoors. SYSTEMATIC REVIEW REGISTRATION: International prospective register of systematic reviews (PROSPERO) Registration Number: CRD42020189886.

Loneliness and personal well-being in young people: Moderating effects of individual, interpersonal, and community factors.

INTRODUCTION: Loneliness is prevalent among young people. But, there is little work exploring the association between loneliness with well-being among this age group. Framed by social-ecological theory, we examined demographic, interpersonal, and community factors associated with personal wellbeing and, critically, identified malleable moderators of the relationship between loneliness and well-being that could be targeted in intervention efforts. METHODS: We used cross-sectional, secondary data from 965 young people (aged 16-24) from the Community Life Survey in England. Loneliness was measured using a single-item direct measure; personal wellbeing was measured through a composite measure containing items assessing happiness, life satisfaction, and a sense that life is worthwhile (α = 0.88). Regression techniques were used to assess associations between individual, interpersonal, and community factors and well-being, and to identify moderators of the relationship between loneliness and well-being. RESULTS: Loneliness was negatively associated with well-being. Chatting with neighbors and having people to provide help moderated the relationship between loneliness and well-being. Full-time students and those with good physical health had higher well-being while being a carer was predictive of lower well-being. All community variables were strongly associated with increased well-being. Of all interpersonal variables investigated, only having people to count on was associated with increased well-being. CONCLUSIONS: Our results demonstrate that supportive relationships and close community ties are important for reducing the negative impact of loneliness on youth well-being. Interventions to improve well-being could benefit from targeting these aspects of young people's social and community lives, while acknowledging individual vulnerabilities, such as poor physical health.

Parents' perceptions of children's emotional well-being during spring 2020 COVID-19 restrictions: A qualitative study with parents of young children in England.

BACKGROUND: During COVID-19 restrictions in England in spring 2020, early years settings for young children were closed to all but a small percentage of families, social contact was limited and play areas in parks were closed. Concerns were raised about the impact of these restrictions on young children's emotional well-being. The aim of this study was to explore parents' perceptions of young children's emotional well-being during these COVID-19 restrictions. METHODS: We interviewed 20 parents of children 3-4 years due to begin school in England in September 2020. Interviews were conducted via telephone (n = 18) and video call (n = 2), audio-recorded and transcribed verbatim. Interviews focused on childcare arrangements, children's behaviour and transition to school. A sample of transcripts were coded line by line to create a coding framework, which was subsequently applied to the remaining transcripts. Coded data were then analysed using a nurture lens to develop themes and further understanding. RESULTS: Participants were predominantly mothers (n = 16), White British (n = 10) and educated to degree level (n = 13), with half the sample living in the highest deprivation quintile in England (n = 10). Five were single parents. Three themes developed from nurturing principles were identified: creating age-appropriate explanations, understanding children's behaviour and concerns about school transition. Parents reported that their children's emotional well-being was impacted and described attempts to support their young children while looking ahead to their transition to primary school. CONCLUSIONS: This study is one of the first to examine in-depth perceptions of COVID-19 restrictions on young children's emotional well-being. The longer term impacts are not yet understood. Although young children may be unable to understand in detail what the virus is, they undoubtedly experience the disruption it brings to their lives. The well-being of families and children needs to be nurtured as they recover from the effects of the pandemic to allow them to thrive.

Healthy eating and lifestyle in pregnancy (HELP): a cluster randomised trial to evaluate the effectiveness of a weight management intervention for pregnant women with obesity on weight at 12 months postpartum.

OBJECTIVE: To assess whether a weight management intervention for pregnant women with obesity was effective in reducing body mass index (BMI) 12 months after giving birth. METHODS: Pragmatic, cluster randomised controlled trial (RCT) with embedded cost-effectiveness analysis. 598 women with a BMI of ≥30 kg/m2 (between 12 and 20 weeks gestation) were recruited from 20 secondary care maternity units in England and Wales. BMI at 12 months postpartum was the primary outcome. A range of clinical and behavioural secondary outcomes were examined. INTERVENTIONS: Women attending maternity units randomised to intervention were invited to a weekly weight management group, which combined expertise from a commercial weight loss programme with clinical advice from midwives. Both intervention and control participants received usual care and leaflets on diet and physical activity in pregnancy. RESULTS: Mean (SD) BMI at 12 months postpartum was 36.0 kg/m2 (5.2) in the control group, and 37.5 kg/m2 (6.7) in the intervention group. After adjustment for baseline BMI, the intervention effect was -0.02 (95% CI -0.04 to 0.01). The intervention group had an improved healthy eating score (3.08, 95% CI 0.16 to 6.00, p < 0.04), improved fibre score (3.22, 1.07 to 5.37, p < 0.01) and lower levels of risky drinking at 12 months postpartum compared to the control group (OR 0.45, 0.27 to 0.74, p < 0.002). The net incremental monetary benefit was not statistically significantly different between arms, although the probability of the intervention being cost-effective was above 60%, at policy-relevant thresholds. CONCLUSIONS: There was no significant difference between groups on the primary outcome of BMI at 12 months. Analyses of secondary outcomes indicated improved healthy eating and lower levels of risky drinking. TRIAL REGISTRATION: Current Controlled Trials ISRCTN25260464.

Effectiveness of social network interventions to support cardiac rehabilitation and secondary prevention in the management of people with heart disease.

This is a protocol for a Cochrane Review (intervention). The objectives are as follows: To assess the effectiveness of social network and social support interventions to support cardiac rehabilitation and secondary prevention in the management of people with heart disease. As a secondary output of this review, and to assist in conceptualising future research focused on social network and social support interventions, we aim to develop a logic model theorising the relationship between social networks or social support and heart disease outcomes. We will draw on existing models of social support for health (e.g. Berkman 2000), as well as established approaches to theorising and implementing behaviour change (e.g. Michie 2011).

Definition and Characteristics of Behavioral Medicine, and Main Tasks and Goals of the International Society of Behavioral Medicine-an International Delphi Study.

BACKGROUND: In the past decades, behavioral medicine has attained global recognition. Due to its global reach, a critical need has emerged to consider whether the original definition of behavioral medicine is still valid, comprehensive, and inclusive, and to reconsider the main tasks and goals of the International Society of Behavioral Medicine (ISBM), as the umbrella organization in the field. The purpose of the present study was to (i) update the definition and scope of behavioral medicine and its defining characteristics; and (ii) develop a proposal on ISBM's main tasks and goals. METHOD: Our study used the Delphi method. A core group prepared a discussion paper. An international Delphi panel rated questions and provided comments. The panel intended to reach an a priori defined level of consensus (i.e., 70%). RESULTS: The international panel reached consensus on an updated definition and scope of behavioral medicine as a field of research and practice that builds on collaboration among multiple disciplines. These disciplines are concerned with development and application of behavioral and biomedical evidence across the disease continuum in clinical and public health domains. Consensus was reached on a proposal for ISBM's main tasks and goals focused on supporting communication and collaboration across disciplines and participating organizations; stimulating research, education, and practice; and supporting individuals and organizations in the field. CONCLUSION: The consensus on definition and scope of behavioral medicine and ISBM's tasks and goals provides a foundational step toward achieving these goals.

Practitioner review: Co-design of digital mental health technologies with children and young people.

BACKGROUND: There is increasing interest in digital technologies to help improve children and young people's mental health, and the evidence for the effectiveness for these approaches is rising. However, there is concern regarding levels of user engagement, uptake and adherence. Key guidance regarding digital health interventions stress the importance of early user input in the development, evaluation and implementation of technologies to help ensure they are engaging, feasible, acceptable and potentially effective. Co-design is a process of active involvement of stakeholders, requiring a change from the traditional approaches to intervention development. However, there is a lack of literature to inform the co-design of digital technologies to help child and adolescent mental health. METHODS: We reviewed the literature and practice in the co-design of digital mental health technologies with children and young people. We searched Medline, PsycInfo and Web of Science databases, guidelines, reviews and reference lists, contacted key authors for relevant studies, and extracted key themes on aspects of co-design relevant to practice. We supplemented this with case studies and methods reported by researchers working in the field. RESULTS: We identified 25 original articles and 30 digital mental health technologies that were designed/developed with children and young people. The themes identified were as follows: principles of co-design (including potential stakeholders and stages of involvement), methods of involving and engaging the range of users, co-designing the prototype and the challenges of co-design. CONCLUSIONS: Co-design involves all relevant stakeholders throughout the life and research cycle of the programme. This review helps to inform practitioners and researchers interested in the development of digital health technologies for children and young people. Future work in this field will need to consider the changing face of technology, methods of engaging with the diversity in the user group, and the evaluation of the co-design process and its impact on the technology.

Acceptability and Feasibility of Implementing Accelorometry-Based Activity Monitors and a Linked Web Portal in an Exercise Referral Scheme: Feasibility Randomized Controlled Trial.

BACKGROUND: Exercise referral schemes (ERSs) are recommended for patients with health conditions or risk factors. Evidence points to the initial effectiveness and cost-effectiveness of such schemes for increasing physical activity, but effects often diminish over time. Techniques such as goal setting, self-monitoring, and personalized feedback may support motivation for physical activity and maintenance of effects. Wearable technologies could provide an opportunity to integrate motivational techniques into exercise schemes. However, little is known about acceptability to exercise referral populations or implementation feasibility within exercise referral services. OBJECTIVE: To determine the feasibility and acceptability of implementing an activity-monitoring device within the Welsh National ERS to inform a decision on whether and how to proceed to an effectiveness trial. METHODS: We conducted a feasability randomized controlled trial with embedded mixed-methods process evaluation and an exploratory economic analysis. Adults (N=156) were randomized to intervention (plus usual practice; n=88) or usual practice only (n=68). Usual practice was a 16-week structured exercise program. The intervention group additionally received an accelerometry-based activity monitor (MyWellnessKey) and associated Web platform (MyWellnessCloud). The primary outcomes were predefined progression criteria assessing acceptability and feasibility of the intervention and proposed evaluation. Postal questionnaires were completed at baseline (time 0:T0), 16 weeks (T1), and 12 months after T0 (T2). Routine data were accessed at the same time-points. A subsample of intervention participants and scheme staff were interviewed following the initiation of intervention delivery and at T2. RESULTS: Participants were on average aged 56.6 (SD 16.3) years and mostly female (101/156, 64.7%) and white (150/156, 96.2%). Only 2 of 5 progression criteria were met; recruitment and randomization methods were acceptable to participants, and contamination was low. However, recruitment and retention rates (11.3% and 67.3%, respectively) fell substantially short of target criteria (20% and 80%, respectively), and disproportionally recruited from the least deprived quintile. Only 57.4% of intervention participants reported receipt of the intervention (below the 80% progression threshold). Less than half reported the intervention to be acceptable at T2. Participant and staff interviews revealed barriers to intervention delivery and engagement related to the device design as well as context-specific technological challenges, all of which made it difficult to integrate the technology into the service. Routinely collected health economic measures had substantial missing data, suggesting that other methods for collecting these should be used in future. CONCLUSIONS: To our knowledge, this is the first study to evaluate short- and long-term feasibility and acceptability of integrating wearable technologies into community-based ERSs. The findings highlight device- and context-specific barriers to doing this in routine practice, with typical exercise referral populations. Key criteria for progression to a full-scale evaluation were not met. TRIAL REGISTRATION: ISRCTN Registry ISRCTN85785652; http://www.isrctn.com/ISRCTN85785652.

Eligibility for interventions, co-occurrence and risk factors for unhealthy behaviours in patients consulting for routine primary care: results from the Pre-Empt study.

BACKGROUND: Smoking, excessive drinking, lack of exercise and a poor diet remain key causes of premature morbidity and mortality globally, yet it is not clear what proportion of patients attending for routine primary care are eligible for interventions about these behaviours, the extent to which they co-occur within individuals, and which individuals are at greatest risk for multiple unhealthy behaviours. The aim of the trial was to examine 'intervention eligibility' and co-occurrence of the 'big four' risky health behaviours - lack of exercise, smoking, an unhealthy diet and excessive drinking - in a primary care population. METHODS: Data were collected from adult patients consulting routinely in general practice across South Wales as part of the Pre-Empt study; a cluster randomised controlled trial. After giving consent, participants completed screening instruments, which included the following to assess eligibility for an intervention based on set thresholds: AUDIT-C (for alcohol), HSI (for smoking), IPAQ (for exercise) and a subset of DINE (for diet). The intervention following screening was based on which combination of risky behaviours the patient had. Descriptive statistics, χ2 tests for association and ordinal regressions were undertaken. RESULTS: Two thousand sixty seven patients were screened: mean age of 48.6 years, 61.9 % female and 42.8 % in a managerial or professional occupation. In terms of numbers of risky behaviours screened eligible for, two was the most common (43.6 %), with diet and exercise (27.2 %) being the most common combination. Insufficient exercise was the most common single risky behaviour (12.0 %). 21.8 % of patients would have been eligible for an intervention for three behaviours and 5.9 % for all four behaviours. Just 4.5 % of patients did not identify any risky behaviours. Women, older age groups and those in managerial or professional occupations were more likely to exhibit all four risky behaviours. CONCLUSION: Very few patients consulting for routine primary care screen ineligible for interventions about common unhealthy behaviours, and most engage in more than one of the major common unhealthy behaviours. Clinicians should be particularly alert to opportunities to engaging younger, non professional men and those with multi-morbidity about risky health behaviour. TRIAL REGISTRATION: ISRCTN22495456.

Healthy eating and lifestyle in pregnancy (HELP): a protocol for a cluster randomised trial to evaluate the effectiveness of a weight management intervention in pregnancy.

BACKGROUND: Approximately 1 in 5 pregnant women in the United Kingdom are obese. In addition to being associated generally with poor health, obesity is known to be a contributing factor to pregnancy and birth complications and the retention of gestational weight can lead to long term obesity.This paper describes the protocol for a cluster randomised trial to evaluate whether a weight management intervention for obese pregnant women is effective in reducing women's Body Mass Index at 12 months following birth. METHODS/DESIGN: The study is a cluster randomised controlled trial involving 20 maternity units across England and Wales. The units will be randomised, 10 to the intervention group and 10 to the control group. 570 pregnant women aged 18 years or over, with a Body Mass Index of +/=30 (kg/m2) and between 12 and 20 weeks gestation will be recruited. Women allocated to the control group will receive usual care and two leaflets giving advice on diet and physical activity. In addition to their usual care and the leaflets, women allocated to the intervention group will be offered to attend a weekly 1.5 hour weight management group, which combines expertise from Slimming World with clinical advice and supervision from National Health Service midwives, until 6 weeks postpartum.Participants will be followed up at 36 weeks gestation and at 6 weeks, 6 months and 12 months postpartum. Body Mass Index at 12 months postpartum is the primary outcome. Secondary outcomes include pregnancy weight gain, quality of life, mental health, waist-hip ratio, child weight centile, admission to neonatal unit, diet, physical activity levels, pregnancy and birth complications, social support, self-regulation and self-efficacy. A cost effectiveness analysis and process evaluation will also be conducted. DISCUSSION: This study will evaluate the effectiveness of a theory-based intervention developed for obese pregnant women. If successful the intervention will equip women with the necessary knowledge and skills to enable them to make healthier choices for themselves and their unborn child. TRIAL REGISTRATION: Current Controlled Trials: ISRCTN25260464 Date of registration: 16th April 2010.

A preoperative package of care for osteoarthritis, consisting of weight loss, orthotics, rehabilitation, and topical and oral analgesia (OPPORTUNITY): a two-centre, open-label, randomised controlled feasibility trial.

BACKGROUND: Osteoarthritis of the knee is a major cause of disability worldwide. Non-operative treatments can reduce the morbidity but adherence is poor. We hypothesised that adherence could be optimised if behavioural change was established in the preoperative period. Therefore, we aimed to assess feasibility, acceptability, and recruitment and retention rates of a preoperative package of non-operative care in patients awaiting knee replacement surgery. METHODS: We did an open-label, randomised controlled, feasibility trial in two secondary care centres in the UK. Eligible participants were aged 15-85 years, on the waiting list for a knee arthroplasty for osteoarthritis, and met at least one of the thresholds for one of the four components of the preoperative package of non-operative care intervention (ie, weight loss, exercise therapy, use of insoles, and analgesia adjustment). Participants were randomly assigned (2:1) to either the intervention group or the standard of care (ie, control) group. All four aspects of the intervention were delivered weekly over 12 weeks. Participants in the intervention group were reviewed regularly to assess adherence. The primary outcome was acceptability and feasibility of delivering the intervention, as measured by recruitment rate, retention rate at follow-up review after planned surgery, health-related quality of life, joint-specific scores, and adherence (weight change and qualitative interviews). This study is registered with ISRCTN, ISRCTN96684272. FINDINGS: Between Sept 3 2018, and Aug 30, 2019, we screened 233 patients, of whom 163 (73%) were excluded and 60 (27%) were randomly assigned to either the intervention group (n=40) or the control group (n=20). 34 (57%) of 60 participants were women, 26 (43%) were men, and the mean age was 66·8 years (SD 8·6). Uptake of the specific intervention components varied: 31 (78%) of 40 had exercise therapy, 28 (70%) weight loss, 22 (55%) analgesia adjustment, and insoles (18 [45%]). Overall median adherence was 94% (IQR 79·5-100). At the final review, the intervention group lost a mean of 11·2 kg (SD 5·6) compared with 1·3 kg (3·8) in the control group (estimated difference -9·8 kg [95% CI -13·4 to -6·3]). A clinically significant improvement in health-related quality o life (mean change 0·078 [SD 0·195]) were reported, and joint-specific scores showed greater improvement in the intervention group than in the control group. No adverse events attributable to the intervention occurred. INTERPRETATION: Participants adhered well to the non-operative interventions and their health-related quality of life improved. Participant and health professional feedback were extremely positive. These findings support progression to a full-scale effectiveness trial. FUNDING: Versus Arthritis.

Evidence for exercise-based interventions across 45 different long-term conditions: an overview of systematic reviews.

Background: Almost half of the global population face significant challenges from long-term conditions (LTCs) resulting in substantive health and socioeconomic burden. Exercise is a potentially key intervention in effective LTC management. Methods: In this overview of systematic reviews (SRs), we searched six electronic databases from January 2000 to October 2023 for SRs assessing health outcomes (mortality, hospitalisation, exercise capacity, disability, frailty, health-related quality of life (HRQoL), and physical activity) related to exercise-based interventions in adults (aged >18 years) diagnosed with one of 45 LTCs. Methodological quality was assessed using AMSTAR-2. International Prospective Resister of Systematic Reviews (PROSPERO) ID: CRD42022319214. Findings: Forty-two SRs plus three supplementary RCTs were included, providing 990 RCTs in 936,825 people across 39 LTCs. No evidence was identified for six LTCs. Predominant outcome domains were HRQoL (82% of SRs/RCTs) and exercise capacity (66%); whereas disability, mortality, physical activity, and hospitalisation were less frequently reported (≤25%). Evidence supporting exercise-based interventions was identified in 25 LTCs, was unclear for 13 LTCs, and for one LTC suggested no effect. No SRs considered multimorbidity in the delivery of exercise. Methodological quality varied: critically-low (33%), low (26%), moderate (26%), and high (12%). Interpretation: Exercise-based interventions improve HRQoL and exercise capacity across numerous LTCs. Key evidence gaps included limited mortality and hospitalisation data and consideration of multimorbidity impact on exercise-based interventions. Funding: This study was funded by the National Institute for Health and Care Research (NIHR; Personalised Exercise-Rehabilitation FOR people with Multiple long-term conditions (multimorbidity)-NIHR202020).

Association of latent class analysis-derived multimorbidity clusters with adverse health outcomes in patients with multiple long-term conditions: comparative results across three UK cohorts.

Background: It remains unclear how to meaningfully classify people living with multimorbidity (multiple long-term conditions (MLTCs)), beyond counting the number of conditions. This paper aims to identify clusters of MLTCs in different age groups and associated risks of adverse health outcomes and service use. Methods: Latent class analysis was used to identify MLTCs clusters in different age groups in three cohorts: Secure Anonymised Information Linkage Databank (SAIL) (n = 1,825,289), UK Biobank (n = 502,363), and the UK Household Longitudinal Study (UKHLS) (n = 49,186). Incidence rate ratios (IRR) for MLTC clusters were computed for: all-cause mortality, hospitalisations, and general practice (GP) use over 10 years, using <2 MLTCs as reference. Information on health outcomes and service use were extracted for a ten year follow up period (between 01st Jan 2010 and 31st Dec 2019 for UK Biobank and UKHLS, and between 01st Jan 2011 and 31st Dec 2020 for SAIL). Findings: Clustering MLTCs produced largely similar results across different age groups and cohorts. MLTC clusters had distinct associations with health outcomes and service use after accounting for LTC counts, in fully adjusted models. The largest associations with mortality, hospitalisations and GP use in SAIL were observed for the "Pain+" cluster in the age-group 18-36 years (mortality IRR = 4.47, hospitalisation IRR = 1.84; GP use IRR = 2.87) and the "Hypertension, Diabetes & Heart disease" cluster in the age-group 37-54 years (mortality IRR = 4.52, hospitalisation IRR = 1.53, GP use IRR = 2.36). In UK Biobank, the "Cancer, Thyroid disease & Rheumatoid arthritis" cluster in the age group 37-54 years had the largest association with mortality (IRR = 2.47). Cardiometabolic clusters across all age groups, pain/mental health clusters in younger groups, and cancer and pulmonary related clusters in older age groups had higher risk for all outcomes. In UKHLS, MLTC clusters were not significantly associated with higher risk of adverse outcomes, except for the hospitalisation in the age-group 18-36 years. Interpretation: Personalising care around MLTC clusters that have higher risk of adverse outcomes may have important implications for practice (in relation to secondary prevention), policy (with allocation of health care resources), and research (intervention development and targeting), for people living with MLTCs. Funding: This study was funded by the National Institute for Health and Care Research (NIHR; Personalised Exercise-Rehabilitation FOR people with Multiple long-term conditions (multimorbidity)-NIHR202020).

Pilot study of a ketogenic diet in bipolar disorder.

BACKGROUND: Recent evidence from case reports suggests that a ketogenic diet may be effective for bipolar disorder. However, no clinical trials have been conducted to date. AIMS: To assess the recruitment and feasibility of a ketogenic diet intervention in bipolar disorder. METHOD: Euthymic individuals with bipolar disorder were recruited to a 6-8 week trial of a modified ketogenic diet, and a range of clinical, economic and functional outcome measures were assessed. Study registration number: ISRCTN61613198. RESULTS: Of 27 recruited participants, 26 commenced and 20 completed the modified ketogenic diet for 6-8 weeks. The outcomes data-set was 95% complete for daily ketone measures, 95% complete for daily glucose measures and 95% complete for daily ecological momentary assessment of symptoms during the intervention period. Mean daily blood ketone readings were 1.3 mmol/L (s.d. = 0.77, median = 1.1) during the intervention period, and 91% of all readings indicated ketosis, suggesting a high degree of adherence to the diet. Over 91% of daily blood glucose readings were within normal range, with 9% indicating mild hypoglycaemia. Eleven minor adverse events were recorded, including fatigue, constipation, drowsiness and hunger. One serious adverse event was reported (euglycemic ketoacidosis in a participant taking SGLT2-inhibitor medication). CONCLUSIONS: The recruitment and retention of euthymic individuals with bipolar disorder to a 6-8 week ketogenic diet intervention was feasible, with high completion rates for outcome measures. The majority of participants reached and maintained ketosis, and adverse events were generally mild and modifiable. A future randomised controlled trial is now warranted.

Internet-based psychoeducation for bipolar disorder: a qualitative analysis of feasibility, acceptability and impact.

BACKGROUND: In a recent exploratory randomised trial we found that a novel, internet-based psychoeducation programme for bipolar disorder (Beating Bipolar) was relatively easy to deliver and had a modest effect on psychological quality of life. We sought to explore the experiences of participants with respect to feasibility, acceptability and impact of Beating Bipolar. METHODS: Participants were invited to take part in a semi-structured interview. Thematic analysis techniques were employed; to explore and describe participants' experiences, the data were analysed for emerging themes which were identified and coded. RESULTS: The programme was feasible to deliver and acceptable to participants where they felt comfortable using a computer. It was found to impact upon insight into illness, health behaviour, personal routines and positive attitudes towards medication. Many participants regarded the programme as likely to be most beneficial for those recently diagnosed. CONCLUSIONS: An online psychoeducation package for bipolar disorder, such as Beating Bipolar, is feasible and acceptable to patients, has a positive impact on self-management behaviours and may be particularly suited to early intervention. Alternative (non-internet) formats should also be made available to patients.