Transferability of the NHS low-calorie diet programme: A qualitative exploration of factors influencing the programme's transfer ahead of wide-scale adoption.

INTRODUCTION: Although behavioural interventions have been found to help control type 2 diabetes (T2D), it is important to understand how the delivery context can influence implementation and outcomes. The NHS committed to testing a low-calorie diet (LCD) programme designed to support people living with excess weight and T2D to lose weight and improve diabetes outcomes. Understanding what influenced implementation during the programme pilot is important in optimising rollout. This study explored the transferability of the NHS LCD Programme prior to wider adoption. METHODS: Twenty-five interviews were undertaken with stakeholders involved in implementing the LCD programme in pilot sites (health service leads, referring health professionals and programme deliverers). Interviews with programme participants (people living with T2D) were undertaken within a larger programme of work, exploring what worked, for whom and why, which is reported separately. The conceptual Population-Intervention-Environment-Transfer Model of Transferability (PIET-T) guided study design and data collection. Constructs of the model were also used as a deductive coding frame during data analysis. Key themes were identified which informed recommendations to optimise programme transfer. RESULTS: Population: Referral strategies in some areas lacked consideration of population characteristics. Many believed that offering a choice of delivery model would promote acceptability and accessibility of the eligible population. INTERVENTION: Overall, stakeholders had confidence in the LCD programme due to the robust evidence base along with anecdotal evidence, but some felt the complex referral process hindered engagement from GP practices. ENVIRONMENT: Stakeholders described barriers to accessing the programme, including language and learning difficulties. Transferability: Multidisciplinary working and effective communication supported successful implementation. CONCLUSION: Referral strategies to reach underrepresented groups should be considered during programme transfer, along with timely data from service providers on access and programme benefits. A choice of delivery models may optimise uptake. Knowledge sharing between sites on good working practices is encouraged, including increasing engagement with key stakeholders.

Debridement for surgical wounds.

BACKGROUND: Surgical wounds that become infected are often debrided because clinicians believe that removal of this necrotic or infected tissue may expedite wound healing. There are numerous methods of debridement available, but no consensus on which one is most effective for surgical wounds. OBJECTIVES: To assess the effects of different methods of debridement on the rate of debridement and healing of surgical wounds. SEARCH METHODS: In October 2021, we searched the Cochrane Wounds Specialised Register, CENTRAL, MEDLINE, Embase, and CINAHL. To identify additional studies, we searched clinical trials registries for ongoing and unpublished studies, and scanned reference lists of relevant included studies, reviews, meta-analyses, and health technology reports. There were no restrictions on language, date of publication, or study setting. SELECTION CRITERIA: We included randomised controlled trials (RCTs) that enrolled people with a surgical wound that required debridement, and reported time to complete wound debridement or time to wound healing, or both. DATA COLLECTION AND ANALYSIS: Two review authors independently performed study selection, risk of bias assessment using the RoB 1 tool, data extraction, and GRADE assessment of the certainty of evidence. MAIN RESULTS: In this fourth update, we identified one additional study for inclusion. The review now includes six studies, with 265 participants, aged three to 91 years. Five studies were published between 1979 and 1990 and one published in 2014. The studies were carried out in hospital settings in China, Denmark, Belgium, and the UK. Six studies provided six comparisons. Due to the heterogeneity of studies, it was not appropriate to conduct meta-analyses. Four studies evaluated the effectiveness of dextranomer beads/paste; however, each study used a different comparator (Eusol-soaked dressings, 10% aqueous polyvinylpyrrolidone, 0.1% chloramine-soaked packs, and silicone foam elastomer dressing). One study compared streptokinase/streptodornase with saline-soaked dressings, and one compared endoscopic surgical debridement with conventional 'open' surgical debridement. Five studies reported time to complete debridement (reported as time to a clean wound bed) and three reported time to complete healing. One study reported effect estimates (surgical debridement via endoscopy versus surgical debridement) for time to a clean wound bed and time to complete wound healing, and it was possible to calculate effect estimates for one other study (dextranomer paste versus silicone foam elastomer) for time to complete wound healing. For the other four studies that did not report effect estimates, it was not possible to calculate time to a clean wound bed or time to complete wound healing due to missing variance and participant exclusions. None of the included studies reported outcomes pertaining to proportion of wounds completely healed, rate of reduction in wound size, rate of infection, or quality of life. All studies had unclear or high risk of bias for at least one key domain. Dextranomer paste/beads (autolytic debridement) compared with four different comparators Four studies compared dextranomer paste or beads with Eusol-soaked gauze (20 participants), 10% aqueous polyvinylpyrrolidone (40 participants), 0.1% chloramine-soaked dressings (28 participants), or silicone foam elastomer (50 participants). There is very low-certainty evidence that there may be no clear difference in time to a clean wound bed between dextranomer beads and Eusol gauze. The study did not report adverse events. There is very low-certainty evidence that there may be no difference in time to a clean wound bed between dextranomer paste and 10% aqueous polyvinylpyrrolidone gauze. There was low-certainty evidence that there may be no difference in deaths and serious adverse events. There may be a difference in time until the wounds were clinically clean and time to complete wound healing between dextranomer paste and 0.1% chloramine favouring 0.1% chloramine, but we are very uncertain. There is low-certainty evidence that there may be no difference in deaths and serious adverse events. There is very low-certainty evidence that there may be no difference in time to complete healing between dextranomer beads and silicone foam elastomer. The study did not report adverse events. Streptokinase/streptodornase solution (enzymatic) compared with saline-soaked dressings One study (21 participants) compared enzymatic debridement with saline-soaked dressings. There is low-certainty evidence that there may be no difference in time to a clean wound bed or secondary suture between streptokinase/streptodornase and saline-soaked dressings. There is very low-certainty evidence that there may be no difference in deaths and serious adverse events. Surgical debridement via endoscopic ('keyhole') surgery compared with surgical debridement by 'open' surgery (the wound is opened using a scalpel) One study (106 participants) reported time to complete wound healing and time to a clean wound bed. There is low-certainty evidence that there may be a reduction in time to complete wound healing and very low-certainty evidence that there may be no difference in time to a clean wound bed with surgical debridement via endoscopy compared to 'open' surgical debridement. The study did not report adverse events. Overall, the evidence was low to very low-certainty for all outcomes. Five included studies were published before 1991 and investigated treatments that are no longer available. Worldwide production of dextranomer products has been discontinued, except for dextranomer paste, which is currently only available in South Africa. Furthermore, Eusol, used in one study as the comparator to dextranomer, is rarely used due to risk of harmful effects on healthy tissue and the enzymatic agent streptokinase/streptodornase is no longer available worldwide. AUTHORS' CONCLUSIONS: Evidence for the effects of different methods of debridement on complete wound debridement and healing of surgical wounds remains unclear. Adequately powered, methodologically robust RCTs evaluating contemporary debridement interventions for surgical wounds are needed to guide clinical decision-making.

Is the NHS low-calorie diet programme delivered as planned? An observational study examining adherence of intervention delivery to service specification.

Obesity and Type 2 Diabetes Mellitus (T2DM) are chronic conditions with significant personal, societal, and economic impacts. Expanding on existing trial evidence, the NHS piloted a 52-week low-calorie diet programme for T2DM, delivered by private providers using total diet replacement products and behaviour change support. This study aimed to determine the extent to which providers and coaches adhered to the service specification outlined by NHS England. An observational qualitative study was conducted to examine the delivery of both one-to-one and group-based delivery of programme sessions. Observations of 122 sessions across eight programme delivery samples and two service providers were completed. Adherence to the service specification was stronger for those outcomes that were easily measurable, such as weight and blood glucose, while less tangible elements of the specification, such as empowering service users, and person-centred delivery were less consistently observed. One-to-one sessions were more successful in their person-centred delivery, and the skills of the coaches delivering the sessions had a strong impact on adherence to the specification. Overall, the results show that there was variability by provider and delivery mode in the extent to which sessions of the NHS Low-Calorie Diet Programme reflected the intended service specification. In subsequent programmes it is recommended that one-to-one sessions are used, with accompanying peer support, and that providers improve standardised training and quality assurance to ensure specification adherence.

Pharmacological interventions for the management of children and adolescents living with obesity-An update of a Cochrane systematic review with meta-analyses.

IMPORTANCE: The effectiveness of anti-obesity medications for children and adolescents is unclear. OBJECTIVE: To update the evidence on the benefits and harms of anti-obesity medication. DATA SOURCES: Cochrane CENTRAL, MEDLINE, ClinicalTrials.gov and WHO ICTRP (1/1/16-17/3/23). STUDY SELECTION: Randomized controlled trials ≥6 months in people <19 years living with obesity. DATA EXTRACTION AND SYNTHESIS: Screening, data extraction and quality assessment conducted in duplicate, independently. MAIN OUTCOMES AND MEASURES: Body mass index (BMI): 95th percentile BMI, adverse events and quality of life. RESULTS: Thirty-five trials (N = 4331), follow-up: 6-24 months; age: 8.8-16.3 years; BMI: 26.2-41.7 kg/m2. Moderate certainty evidence demonstrated a -1.71 (95% confidence interval [CI]: -2.27 to -1.14)-unit BMI reduction, ranging from -0.8 to -5.9 units between individual drugs with semaglutide producing the largest reduction of -5.88 kg/m2 (95% CI: -6.99 to -4.77, N = 201). Drug type explained ~44% of heterogeneity. Low certainty evidence demonstrated reduction in 95th percentile BMI: -11.88 percentage points (95% CI: -18.43 to -5.30, N = 668). Serious adverse events and study discontinuation due to adverse events did not differ between medications and comparators, but medication dose adjustments were higher compared to comparator (10.6% vs 1.7%; RR = 3.74 [95% CI: 1.51 to 9.26], I2 = 15%), regardless of approval status. There was a trend towards improved quality of life. Evidence gaps exist for children, psychosocial outcomes, comorbidities and weight loss maintenance. CONCLUSIONS AND RELEVANCE: Anti-obesity medications in addition to behaviour change improve BMI but may require dose adjustment, with 1 in 100 adolescents experiencing a serious adverse event.

Commercial provider staff experiences of the NHS low calorie diet programme pilot: a qualitative exploration of key barriers and facilitators.

BACKGROUND: The National Health Service Type 2 Diabetes Path to Remission programme in England (known as the NHS Low Calorie Diet programme when piloted) was established to support people living with excess weight and Type 2 Diabetes to lose weight and improve their glycaemic control. A mixed method evaluation was commissioned to provide an enhanced understanding of the long-term cost effectiveness of the pilot programme, its implementation, equity and transferability across broad and diverse populations. This study provided key insights on implementation and equity from the service providers' perspective. METHODS: Thirteen focus groups were conducted with commercial providers of the programme, during the initial pilot rollout. Participants were purposively sampled across all provider organisations and staff roles involved in implementing and delivering the programme. Normalisation Process Theory (NPT) was used to design the topic schedule, with the addition of topics on equity and person-centredness. Data were thematically analysed using NPT constructs with additional inductively created codes. Codes were summarised, and analytical themes generated. RESULTS: The programme was found to fulfil the requirements for normalisation from the providers' perspective. However, barriers were identified in engaging GP practices and receiving sufficient referrals, as well as supporting service users through challenges to remain compliant. There was variation in communication and training between provider sites. Areas for learning and improvement included adapting systems and processes and closing the gap where needs of service users are not fully met. CONCLUSIONS: The evaluation of the pilot programme demonstrated that it was workable when supported by effective primary care engagement, comprehensive training, and effective internal and external communication. However, limitations were identified in relation to programme specifications e.g. eligibility criteria, service specification and local commissioning decisions e.g. pattern of roll out, incentivisation of general practice. A person-centred approach to care is fundamental and should include cultural adaptation(s), and the assessment and signposting to additional support and services where required.

The efficacy of sleep lifestyle interventions for the management of overweight or obesity in children: a systematic review and meta-analysis.

BACKGROUND: Childhood obesity remains a significant public health concern. Sleep duration and quality among children and youth are suboptimal worldwide. Accumulating evidence suggests an association between inadequate sleep and obesity risk, yet it is unclear whether this relationship is causal. This systematic review examines the efficacy of sleep interventions alone or as a part of lifestyle interventions for the management of overweight or obesity among children and adolescents. METHODS: A keyword/reference search was performed twice, in January 2021 and May 2022 in MEDLINE/PubMed, EMBASE/Ovid, PsycINFO/EBSCO, The Cochrane Library, Web of Science Core Collection/Web of Science, SciELO/Web of Science, and CINAHL/EBSCO. Study eligibility criteria included youth with overweight or obesity between 5 and 17, were RCTs or quasi-randomized, and focused on the treatment of overweight and obesity with a sleep behavior intervention component. Risk of bias was assessed using the Cochrane Risk of Bias assessment tool (RoB2). A Meta-analysis was conducted to estimate the effect of interventions with a sleep component on BMI. The study protocol was registered in PROSPERO (CRD42021233329). RESULTS: A total of 8 studies (2 quasi-experiments, 6 RCTs) met inclusion criteria and accounted for 2,231 participants across 7 countries. Only one study design isolated the effect of sleep in the intervention and reported statistically significant decreases in weight and waist circumference compared to control, though we rated it at high risk of bias. Our meta-analysis showed no significant overall effect on children's BMI as a result of participation in an intervention with a sleep component (Cohen's d = 0.18, 95% CI= -0.04, 0.40, Z = 1.56, P = .11), though caution is warranted due to substantial heterogeneity observed across studies (Tau2 = 0.08; X2 = 23.05, df = 7; I2 = 83.73%). CONCLUSIONS: There were mixed results on the effect of sleep interventions across included studies on BMI, other weight-related outcomes, diet, physical activity, and sleep. Except for one study at low risk of bias, three were rated as 'some concerns' and four 'high risk of bias'. Findings from this study highlight the need for additional RCTs isolating sleep as a component, focusing on children and adolescents living with overweight and obesity.

Mini-AFTERc: a controlled pilot trial of a nurse-led psychological intervention for fear of breast cancer recurrence.

OBJECTIVES: To determine the feasibility and acceptability of implementing the Mini-AFTERc intervention. DESIGN: Non-randomised cluster-controlled pilot trial. SETTING: Four NHS out-patient breast cancer centres in Scotland. PARTICIPANTS: Ninety-two women who had successfully completed primary treatment for breast cancer were screened for moderate levels of fear of cancer recurrence (FCR). Forty-five were eligible (17 intervention and 28 control) and 34 completed 3-month follow-up (15 intervention and 21 control). INTERVENTION: Mini-AFTERc, a single brief (30 min) structured telephone discussion with a specialist breast cancer nurse (SBCN) trained to target the antecedents of FCR. OUTCOMES: Feasibility and acceptability of Mini-AFTERc and the study design were assessed via recruitment, consent, retention rates, patient outcomes (measured at baseline, 2, 4, and 12 weeks), and post-study interviews with participants and SBCNs, which were guided by Normalisation Process Theory. RESULTS: Mini-AFTERc was acceptable to patients and SBCNs. SBCNs believe the implementation of Mini-AFTERc to be feasible and an extension of discussions that already happen routinely. SBCNs believe delivery, however, at the scale required would be challenging given current competing demands for their time. Recruitment was impacted by variability in the follow-up practices of cancer centres and COVID-19 lockdown. Consent and follow-up procedures worked well, and retention rates were high. CONCLUSIONS: The study provided invaluable information about the potential challenges and solutions for testing the Mini-AFTERc intervention more widely where limiting high FCR levels is an important goal following recovery from primary breast cancer treatment. TRIAL REGISTRATION: ClinicalTrials.gov, NCT0376382 . Registered on 4 December 2018.

Associations between anxiety, depression, and weight status during and after pregnancy: A systematic review and meta-analysis.

Previous work has found adverse mental health symptomology in women living with obesity, compared with those of healthy weight, around the time of pregnancy. This meta-analysis aimed to explore the association between anxiety, depression, and weight status in women living with obesity before, during, and after pregnancy. Bibliographic databases were systematically searched, and 14 studies were included, which aimed to assess the association between excess weight and anxiety or depression outcomes in women before, during, or after pregnancy. Data were analyzed via narrative synthesis and random effects multi-level meta-analyses. Scores on mental health indices were significantly greater (indicative of worse anxiety/depression) in women with obesity compared to women of a healthy weight, around the time of pregnancy (SMD = 0.21 [95% CI: 0.11-0.31; 95% prediction intervals: 0.13-0.56], I2  = 73%, p < 0.01). Depressive symptoms were greater during and after pregnancy (SMD = 0.23 [95% CI: 0.13-0.34; 95% prediction intervals: -0.12 to 0.59], I2  = 75.0%, p < 0.01), and trait anxiety symptoms were greater during pregnancy (SMD = 0.24 [95% CI: 0.01-0.47; 95% prediction intervals: -0.25 to 0.72], I2  = 83.7%, p = 0.039) in women living with obesity, compared to those of healthy weight. Narrative evidence suggests that socioeconomic status and ethnicity may modify the relationship between obesity and mental health symptomology. The findings indicate that maternal obesity is associated with greater anxiety and depression symptoms. These findings may inform the design of maternal weight management interventions.

Cell salvage for minimising perioperative allogeneic blood transfusion in adults undergoing elective surgery.

BACKGROUND: Concerns regarding the safety and availability of transfused donor blood have prompted research into a range of techniques to minimise allogeneic transfusion requirements. Cell salvage (CS) describes the recovery of blood from the surgical field, either during or after surgery, for reinfusion back to the patient. OBJECTIVES: To examine the effectiveness of CS in minimising perioperative allogeneic red blood cell transfusion and on other clinical outcomes in adults undergoing elective or non-urgent surgery. SEARCH METHODS: We searched CENTRAL, MEDLINE, Embase, three other databases and two clinical trials registers for randomised controlled trials (RCTs) and systematic reviews from 2009 (date of previous search) to 19 January 2023, without restrictions on language or publication status. SELECTION CRITERIA: We included RCTs assessing the use of CS compared to no CS in adults (participants aged 18 or over, or using the study's definition of adult) undergoing elective (non-urgent) surgery only. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures expected by Cochrane. MAIN RESULTS: We included 106 RCTs, incorporating data from 14,528 participants, reported in studies conducted in 24 countries. Results were published between 1978 and 2021. We analysed all data according to a single comparison: CS versus no CS. We separated analyses by type of surgery. The certainty of the evidence varied from very low certainty to high certainty. Reasons for downgrading the certainty included imprecision (small sample sizes below the optimal information size required to detect a difference, and wide confidence intervals), inconsistency (high statistical heterogeneity), and risk of bias (high risk from domains including sequence generation, blinding, and baseline imbalances). Aggregate analysis (all surgeries combined: primary outcome only) Very low-certainty evidence means we are uncertain if there is a reduction in the risk of allogeneic transfusion with CS (risk ratio (RR) 0.65, 95% confidence interval (CI) 0.59 to 0.72; 82 RCTs, 12,520 participants). Cancer: 2 RCTs (79 participants) Very low-certainty evidence means we are uncertain whether there is a difference for mortality, blood loss, infection, or deep vein thrombosis (DVT). There were no analysable data reported for the remaining outcomes. Cardiovascular (vascular): 6 RCTs (384 participants) Very low- to low-certainty evidence means we are uncertain whether there is a difference for most outcomes. No data were reported for major adverse cardiovascular events (MACE). Cardiovascular (no bypass): 6 RCTs (372 participants) Moderate-certainty evidence suggests there is probably a reduction in risk of allogeneic transfusion with CS (RR 0.82, 95% CI 0.69 to 0.97; 3 RCTs, 169 participants). Very low- to low-certainty evidence means we are uncertain whether there is a difference for volume transfused, blood loss, mortality, re-operation for bleeding, infection, wound complication, myocardial infarction (MI), stroke, and hospital length of stay (LOS). There were no analysable data reported for thrombosis, DVT, pulmonary embolism (PE), and MACE. Cardiovascular (with bypass): 29 RCTs (2936 participants) Low-certainty evidence suggests there may be a reduction in the risk of allogeneic transfusion with CS, and suggests there may be no difference in risk of infection and hospital LOS. Very low- to moderate-certainty evidence means we are uncertain whether there is a reduction in volume transfused because of CS, or if there is any difference for mortality, blood loss, re-operation for bleeding, wound complication, thrombosis, DVT, PE, MACE, and MI, and probably no difference in risk of stroke. Obstetrics: 1 RCT (1356 participants) High-certainty evidence shows there is no difference between groups for mean volume of allogeneic blood transfused (mean difference (MD) -0.02 units, 95% CI -0.08 to 0.04; 1 RCT, 1349 participants). Low-certainty evidence suggests there may be no difference for risk of allogeneic transfusion. There were no analysable data reported for the remaining outcomes. Orthopaedic (hip only): 17 RCTs (2055 participants) Very low-certainty evidence means we are uncertain if CS reduces the risk of allogeneic transfusion, and the volume transfused, or if there is any difference between groups for mortality, blood loss, re-operation for bleeding, infection, wound complication, prosthetic joint infection (PJI), thrombosis, DVT, PE, stroke, and hospital LOS. There were no analysable data reported for MACE and MI. Orthopaedic (knee only): 26 RCTs (2568 participants) Very low- to low-certainty evidence means we are uncertain if CS reduces the risk of allogeneic transfusion, and the volume transfused, and whether there is a difference for blood loss, re-operation for bleeding, infection, wound complication, PJI, DVT, PE, MI, MACE, stroke, and hospital LOS. There were no analysable data reported for mortality and thrombosis. Orthopaedic (spine only): 6 RCTs (404 participants) Moderate-certainty evidence suggests there is probably a reduction in the need for allogeneic transfusion with CS (RR 0.44, 95% CI 0.31 to 0.63; 3 RCTs, 194 participants). Very low- to moderate-certainty evidence suggests there may be no difference for volume transfused, blood loss, infection, wound complication, and PE. There were no analysable data reported for mortality, re-operation for bleeding, PJI, thrombosis, DVT, MACE, MI, stroke, and hospital LOS. Orthopaedic (mixed): 14 RCTs (4374 participants) Very low- to low-certainty evidence means we are uncertain if there is a reduction in the need for allogeneic transfusion with CS, or if there is any difference between groups for volume transfused, mortality, blood loss, infection, wound complication, PJI, thrombosis, DVT, MI, and hospital LOS. There were no analysable data reported for re-operation for bleeding, MACE, and stroke. AUTHORS' CONCLUSIONS: In some types of elective surgery, cell salvage may reduce the need for and volume of allogeneic transfusion, alongside evidence of no difference in adverse events, when compared to no cell salvage. Further research is required to establish why other surgeries show no benefit from CS, through further analysis of the current evidence. More large RCTs in under-reported specialities are needed to expand the evidence base for exploring the impact of CS.

Psychometric testing of the Rheumatoid Arthritis Work Instability Scale in employed people with fibromyalgia.

OBJECTIVE: The aim of the study was to establish whether the Rheumatoid Arthritis Work Instability Scale (RA-WIS), in its current form, is applicable for use with employed people with fibromyalgia (FM) to identify the risk of work disability and need for work rehabilitation. METHODS: Content validity was first investigated using cognitive debriefing interviews. Participants completed a postal questionnaire. Construct validity was assessed using Rasch analysis. Concurrent validity included testing between the RA-WIS and work (e.g., Workplace Activity Limitations Scale) and health (FM Impact Questionnaire-Revised (FIQ-R) scales. Two weeks later, participants were mailed a second questionnaire to measure test-retest reliability. RESULTS: Interviews were conducted with 13 participants with FM. All RA-WIS items were considered very or extremely relevant by almost all participants, with only one suggesting other items (anxiety and brain fog). Questionnaire responses were analysed from 156 employed participants: 94% women; 45.71 (SD 10.05) years of age; with time since FM diagnosis 2.99 (4.17) years (symptom duration 8.36 (SD 7.16) years). The RA-WIS mostly satisfied Rasch model requirements and a Rasch transformation scale was created. Concurrent validity was generally good (rs = 0.55-0.66) with work scales and the FIQ-R. Internal consistency (Person Separation Index values) was consistent with group use in FM, not individual level use. Test-retest reliability was excellent, with intraclass coefficient (2, 1) = 0.90. DISCUSSION: The RA-WIS is valid and reliable for group use in employed people with FM. However, further work is needed to develop a WIS for individual use in FM.

Work limitations and associated factors in rheumatoid arthritis, axial spondyloarthritis, osteoarthritis and fibromyalgia.

INTRODUCTION: Rheumatic and musculoskeletal diseases (RMD) impact on work participation. The aims of this study were to: examine work limitations of working people with: rheumatoid arthritis, axial spondyloarthritis (axSpA), osteoarthritis, or fibromyalgia using the Workplace Activity Limitations Scale (WALS, a measure of presenteeism); and identify personal, functioning and disability, and work contextual factors associated with presenteeism. METHODS: Secondary analysis was conducted of a cross-sectional survey including work outcome measures (WORK-PROM study). A literature review identified variables (coded to ICF) to include in multivariable regressions examining factors associated with presenteeism. RESULTS: Moderate to high WALS scores were identified in: 93.60% with FM; 69.90% OA; 65.20% RA; and 46.80% axSpA (n = 822). Similarities in work limitations were noted across conditions, although some more problematic in specific RMD. Participants received help with about a quarter of activities (27%RA; 25%FM; 23%OA; 17%axSpA) and work adaptations for less than a fifth causing difficulty (18%FM; 14%RA; 14%OA; 9%axSpA). Literature review identified 33 variables in the WORK-PROM dataset to include in multivariable regressions. Factors associated with higher WALS scores were worse: functional limitations, job strain, pain, difficulties with mental-interpersonal job demands, perceived health status, work-life balance, greater need for work accommodations and lack of perceived work support. DISCUSSION: This study extends understanding of work limitations of working people with these four RMD, the extent of help and adaptations received, need for more work accommodation support, and focus on work support, work rehabilitation, and healthy workplace practices to help keep people working.

Effectiveness of interventions to improve employment for people released from prison: systematic review and meta-analysis.

BACKGROUND: People released from prison experience complex health challenges in addition to challenges resettling into the community. Consequently, employment rates are low. Participating in good quality employment can support good health and is protective against future reoffending. Multiple interventions are provided to support people into employment on release. The effectiveness of interventions for improving employment outcomes has not previously been evaluated in a meta-analysis. AIM: Our objective was to examine the effectiveness of interventions to improve employment following release from prison. METHOD: We searched seven databases and three trial registries for peer reviewed randomised controlled trials (RCTs), published since 2010, that included adults and measured an employment outcome(s). We conducted meta-analysis using random effects models with sub-group and sensitivity analyses. We appraised bias risk per outcome, and incorporated this into an assessment of the certainty estimates for each outcome. A group of people with experience of imprisonment met with us throughout the project to inform our search strategy and interpretation of results. RESULTS: We included 12 RCTs (2,875 participants) which were all conducted in the USA. Few outcomes were of low risk of bias. Intervention participants were 2.5 times more likely to work at least one day (95% CI:1.82-3.43) and worked more days over 12 months (MD = 59.07, 95% CI:15.83-102.32) compared to controls. There was no effect on average employment status or employment at study end. There is moderate certainty in these estimates. CONCLUSION: Interventions can improve some employment outcomes for people released from prison. More evidence is required to establish effective interventions for sustaining quality employment, particularly outside the USA, and which consider outcomes for different groups of people released, such as women or those with health or substance use needs.

Social, health and economic impact of COVID-19: Healthy Ageing In Scotland (HAGIS) - a protocol for a mixed-methods study.

INTRODUCTION: Public health responses to the COVID-19 pandemic have reaped adverse physical, psychological, social and economic effects, with older adults disproportionally affected. Psychological consequences of the pandemic include fear, worry and anxiety. COVID-19 fear may impact individuals' mitigation behaviours, influencing their willingness to (re)engage in health, social and economic behaviours. This study seeks (1) to develop a robust and evidence-based questionnaire to measure the prevalence of COVID-19 fear among older adults (aged ≥50) in Scotland and (2) to examine the impact of COVID-19 fear on the willingness of older adults to (re)engage across health, social and economic domains as society adjusts to the 'new normal' and inform policy and practice. METHODS AND ANALYSIS: This mixed-method study includes a large-scale multimodal survey, focus groups and interviews with older adults (aged ≥50) living in Scotland, and an email-based 'e-Delphi' consultation with professionals working with older adults. The COVID-19 fear scale was developed and validated using exploratory and confirmatory factor analyses. Survey data will be analysed using descriptive and inferential statistics. Thematic analysis will be used to analyse qualitative data. Survey and qualitative findings will be triangulated and used as the starting point for an 'e-Delphi' consensus consultation with expert stakeholders. ETHICS AND DISSEMINATION: Ethical approval has been obtained from the University of Stirling for multimodal survey development, fieldwork methodology and data management. Anonymised survey data will be deposited with the UK Data Service, with a link provided via the Gateway to Global Ageing. Qualitative data will be deposited with the University of Stirling online digital repository-DataSTORRE. A dedicated work package will oversee dissemination via a coproduced project website, conference presentations, rapid reports and national and international peer-reviewed journal articles. There is planned engagement with Scottish and UK policy makers to contribute to the UK government's COVID-19 recovery strategy.

Psychological support within tier 2 adult weight management services, are we doing enough for people with mental health needs? A mixed-methods survey.

Depression and obesity are two of the most highly prevalent global public health concerns. Obesity and poor mental health are strongly associated, and it is likely that mental health needs are common in people seeking weight management services. The aim was to identify what psychological support is provided and required in tier 2 adult weight management services (T2 WMS). Online survey was conducted: quantitative data were summarized, and open-ended free-text questions were coded and thematically analysed. Participants were current or recent service users with self-reported mental health needs (n = 27), commissioners (n = 9) or providers (n = 17). Over half of service users did not feel their mental health needs were met and 60% said they would like additional psychological support within T2 WMS. Findings highlight the lack of psychological and emotional support. Psychological support and behaviour change techniques are conflated, with a lack of clear understanding or definition of what psychological support is, either between or within service users, providers, and commissioners. Moving towards more person-centred care, better identification and triaging of those living with mental health issues, together with improved resources and training of providers, is crucial to improve outcomes for people living with obesity and poor mental health.

EASO and EFAD Position Statement on Medical Nutrition Therapy for the Management of Overweight and Obesity in Children and Adolescents.

INTRODUCTION: This position statement on medical nutrition therapy in the management of overweight or obesity in children and adolescents was prepared by an expert committee convened by the European Association for the Study of Obesity (EASO) and developed in collaboration with the European Federation of the Associations of Dietitians (EFAD). METHODS: It is based on the best evidence available from systematic reviews of randomized controlled trials on child and adolescent overweight and obesity treatment and other relevant peer-reviewed literature. RESULTS: Multicomponent behavioural interventions are generally considered to be the gold standard treatment for children and adolescents living with obesity. The evidence presented in this position statement confirms that dietary interventions can effectively improve adiposity-related outcomes. Dietary strategies should focus on the reduction of total energy intake through promotion of food-based guidelines that target modification of usual eating patterns and behaviours. These should target increasing intakes of nutrient-rich foods with a lower energy density, specifically vegetables and fruits, and a reduction in intakes of energy-dense nutrient-poor foods and beverages. In addition, higher intensity, longer duration treatments, delivered by interventionists with specialized dietetic-related skills and co-designed with families, are associated with greater treatment effects. DISCUSSION: Such interventions should be resourced adequately so that they can be implemented in a range of settings and in different formats, including digital or online delivery, to enhance accessibility.

European Association for the Study of Obesity Position Statement on Medical Nutrition Therapy for the Management of Overweight and Obesity in Adults Developed in Collaboration with the European Federation of the Associations of Dietitians.

INTRODUCTION: Obesity affects nearly 1 in 4 European adults increasing their risk for mortality and physical and psychological morbidity. Obesity is a chronic relapsing disease characterized by abnormal or excessive adiposity with risks to health. Medical nutrition therapy based on the latest scientific evidence should be offered to all Europeans living with obesity as part of obesity treatment interventions. METHODS: A systematic review was conducted to identify the latest evidence published in the November 2018-March 2021 period and to synthesize them in the European guidelines for medical nutrition therapy in adult obesity. RESULTS: Medical nutrition therapy should be administered by trained dietitians as part of a multidisciplinary team and should aim to achieve positive health outcomes, not solely weight changes. A diverse range of nutrition interventions are shown to be effective in the treatment of obesity and its comorbidities, and dietitians should consider all options and deliver personalized interventions. Although caloric restriction-based interventions are effective in promoting weight reduction, long-term adherence to behavioural changes may be better supported via alternative interventions based on eating patterns, food quality, and mindfulness. The Mediterranean diet, vegetarian diets, the Dietary Approaches to Stop Hypertension, portfolio diet, Nordic, and low-carbohydrate diets have all been associated with improvement in metabolic health with or without changes in body weight. In the November 2018-March 2021 period, the latest evidence published focused around intermittent fasting and meal replacements as obesity treatment options. Although the role of meal replacements is further strengthened by the new evidence, for intermittent fasting no evidence of significant advantage over and above continuous energy restriction was found. Pulses, fruit and vegetables, nuts, whole grains, and dairy foods are also important elements in the medical nutrition therapy of adult obesity. DISCUSSION: Any nutrition intervention should be based on a detailed nutritional assessment including an assessment of personal values, preferences, and social determinants of eating habits. Dietitians are expected to design interventions that are flexible and person centred. Approaches that avoid caloric restriction or detailed eating plans (non-dieting approaches) are also recommended for improvement of quality of life and body image perceptions.

The impact of Allied Health Professionals on the primary and secondary prevention of obesity in young children: A scoping review.

Allied Health Professionals (AHPs) have the capacity to promote healthy behaviours in young children through routine 'contact points', as well as structured weight management programmes. This scoping review aims to evaluate the impact of AHPs in the prevention of obesity in young children. Databases were searched for relevant evidence between 1st January 2000 and 17th January 2022. Eligibility criteria included primary evidence (including, but not limited to; randomized controlled trials, observational studies, service evaluations) evaluating the impact of AHPs on the primary and secondary prevention of obesity in young children (mean age under 5 years old). AHP-related interventions typically demonstrated improvements in outcomes such as nutritional behaviour (e.g. lower sweetened drink intake), with some reductions in screen time. However, changes in weight outcomes (e.g. body mass index (BMI) z-score, BMI) in response to an AHP intervention were inconsistent. There was insufficient data to determine moderating effects, however tentative evidence suggests that those with a lower socioeconomic status or living in an underprivileged area may be more likely to lose weight following an AHP intervention. There was no evidence identified evaluating how AHPs use routine 'contact points' in the prevention of obesity in young children. AHP interventions could be effective in optimizing weight and nutritional outcomes in young children. However, more research is required to determine how routine AHP contact points, across the range of professional groups may be used in the prevention of obesity in young children.

Interventions for health-related physical fitness and overweight and obesity in children with intellectual disability: Systematic review and meta-analysis.

BACKGROUND: Poor health-related physical fitness (HRPF) and overweight and obesity are common health problems for children with intellectual disability. This study aimed to review existing lifestyle intervention studies, and identify effective strategies for this population. METHODS: A systematic search was undertaken in three databases. The random-effects model was used to pool the weighted results by inverse variance methods, and the I2 statistic was applied to assess heterogeneity among the included studies. RESULTS: Most of the identified interventions (27/29) adopted physical activity (PA). For obesity-related outcomes, the results showed no significant effect of PA studies on reducing obesity. For HRPF outcomes, significant effects were found on 6-min walk distance (51.86 m, 95% CI [16.49, 87.22], p < .05). CONCLUSIONS: PA is the predominant intervention component adopted and may contribute to improving cardiopulmonary fitness; but the lack of research limits our ability to draw any confirmed conclusion on obesity-related outcomes and other HRPF outcomes.

Surgery for deep venous insufficiency.

BACKGROUND: Chronic deep venous insufficiency is caused by incompetent vein valves, blockage of large-calibre leg veins, or both; and causes a range of symptoms including recurrent ulcers, pain and swelling. Most surgeons accept that well-fitted graduated compression stockings (GCS) and local care of wounds serve as adequate treatment for most people, but sometimes symptoms are not controlled and ulcers recur frequently, or they do not heal despite compliance with conservative measures. In these situations, in the presence of severe venous dysfunction, surgery has been advocated by some vascular surgeons. This is an update of the review first published in 2000. OBJECTIVES: To assess the effects of surgical management of deep venous insufficiency on ulcer healing and recurrence, complications of surgery, clinical outcomes, quality of life (QoL) and pain. SEARCH METHODS: The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase and CINAHL databases, and the WHO ICTRP and ClinicalTrials.gov trials registries to 23 June 2020. SELECTION CRITERIA: We considered randomised controlled trials (RCTs) of surgical treatment versus another surgical procedure, usual care or no treatment, for people with deep venous insufficiency. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trials for inclusion, extracted data and assessed the risk of bias with the Cochrane risk of bias tool. We evaluated the certainty of the evidence using GRADE. We were unable to pool data due to differences in outcomes reported and how these were measured. Outcomes of interest were ulcer healing and recurrence, complications of surgery, clinical changes, QoL and pain. MAIN RESULTS: We included four RCTs (273 participants) comparing valvuloplasty plus surgery of the superficial venous system with surgery of the superficial venous system for primary valvular incompetence. Follow-up was two to 10 years. All included studies investigated primary valve incompetence. No studies investigated other surgical procedures for the treatment of people with deep venous insufficiency or surgery for secondary valvular incompetence or venous obstruction. The certainty of the evidence was downgraded for risk of bias concerns and imprecision due to small numbers of included trials, participants and events. None of the studies reported ulcer healing or ulcer recurrence. One study included 27 participants with active venous ulceration at the time of surgery; the other three studies did not include people with ulcers. There were no major complications of surgery, no incidence of deep vein thrombosis and no deaths reported (very low-certainty evidence). All four studies reported clinical changes but the data could not be pooled due to different outcome measures and reporting of the data. Two studies assessed clinical changes using subjective and objective measurements, as specified in the clinical, aetiological, anatomical and pathophysiological (CEAP) classification score (low-certainty evidence). One study reported mean CEAP severity scores and one study reported change in clinical class using CEAP. At baseline, the mean CEAP severity score was 18.1 (standard deviation (SD) 4.4) for limbs undergoing external valvuloplasty with surgery to the superficial venous system and 17.8 (SD 3.4) for limbs undergoing surgery to the superficial venous system only. At three years post-surgery, the mean CEAP severity score was 5.2 (SD 1.6) for limbs that had undergone external valvuloplasty with surgery to the superficial venous system and 9.2 (SD 2.6) for limbs that had undergone surgery to the superficial venous system only (low-certainty evidence). In another study, participants with progressive clinical dynamics over the five years preceding surgery had higher rates of improvement in clinical condition in the treatment group (valvuloplasty plus ligation) compared with the control group (ligation only) (80% versus 51%) after seven years of follow-up. Participants with stable preoperative clinical dynamics demonstrated similar rates of improvement in both groups (95% with valvuloplasty plus ligation versus 90% with ligation only) (low-certainty evidence). One study reported disease-specific QoL using cumulative scores from a 10-item visual analogue scale (VAS) and reported that in the limited anterior plication (LAP) plus superficial venous surgery group the score decreased from 49 to 11 at 10 years, compared to a decrease from 48 to 36 in participants treated with superficial venous surgery only (very low-certainty evidence). Two studies reported pain. Within the QoL VAS scale, one item was 'pain/discomfort' and scores decreased from 4 to 1 at 10 years for participants in the LAP plus superficial venous surgery group and increased from 2 to 3 at 10 years in participants treated with superficial venous surgery only. A second study reported that 'leg heaviness and pain' was resolved completely in 36/40 limbs treated with femoral vein external valvuloplasty plus high ligation and stripping of the great saphenous vein (GSV) and percutaneous continuous circumsuture and 22/40 limbs treated with high ligation and stripping of GSV and percutaneous continuous circumsuture alone, at three years' follow-up (very low-certainty evidence). AUTHORS' CONCLUSIONS: We only identified evidence from four RCTs for valvuloplasty plus surgery of the superficial venous system for primary valvular incompetence. We found no studies investigating other surgical procedures for the treatment of people with deep venous insufficiency, or that included participants with secondary valvular incompetence or venous obstruction. None of the studies reported ulcer healing or recurrence, and few studies reported complications of surgery, clinical outcomes, QoL and pain (very low- to low-certainty evidence). Conclusions on the effectiveness of valvuloplasty for deep venous insufficiency cannot be made.

Specialist breast care nurses for support of women with breast cancer.

BACKGROUND: Interventions by specialist breast cancer nurses (SBCNs) aim to support women and help them cope with the impact of the disease on their quality of life. OBJECTIVES: To assess the effects of individual interventions carried out by SBCNs on indicators of quality of life, anxiety, depression, and participant satisfaction. SEARCH METHODS: In June 2020, we searched MEDLINE, Embase, CENTRAL (Trials only), Cochrane Breast Cancer Group's Specialist Register (CBCG SR), CINAHL, PsycINFO, World Health Organization International Clinical Trials Registry Platform (WHO ICTRP) and Clinicaltrials.gov. SELECTION CRITERIA: We selected randomised controlled trials (RCTs) of interventions carried out by SBCNs for women with breast cancer, which reported indicators of quality of life, anxiety, depression, and participant satisfaction. DATA COLLECTION AND ANALYSIS: The certainty of the evidence was evaluated using the GRADE approach. A narrative description of the results including structured tabulation was carried out. MAIN RESULTS: We included 14 RCTs involving 2905 women. With the exception of one study (women with advanced breast cancer), all the women were diagnosed with primary breast cancer. Mean age ranged from 48 to 64 years. Psychosocial nursing interventions compared with standard care for women with primary breast cancer Eight studies (1328 women, low-quality evidence) showed small improvements in general health-related quality of life or no difference in effect between nine weeks and 18 months. Six studies (897 women, low-quality evidence) showed small improvements in cancer-specific quality of life or no difference in effect between nine weeks and 18 months. Six studies (951 women, low-quality evidence) showed small improvements in anxiety and depression between nine weeks and 18 months. Two studies (320 women, low-quality evidence) measured satisfaction during survivorship; one study measured satisfaction only in the intervention group and showed high levels of satisfaction with care; the second study showed equal satisfaction with care in both groups at six months. Psychosocial nursing interventions compared with other supportive care interventions for women with primary breast cancer Two studies (351 women, very-low quality evidence) measured general health-related quality of life. One study reported that psychological morbidity reduced over the 12-month period; scores were consistently lower in women supported by SBCNs alone compared to support from a voluntary organisation. The other study reported that at six months, women receiving psychosocial support by either SBCNs or psychologists clinically improved from "higher levels of distress" to "lower levels of distress". One study (179 women, very-low quality evidence) showed no between-group differences on subscales at all time points up to six months measured using cancer-specific quality of life questionnaires. There were significant group-by-time changes in the global quality of life, nausea and vomiting, and systemic therapy side effects subscales, for women receiving psychosocial support by either SBCNs or psychologists at six months. There were improvements in other subscales over time in both groups. Systemic therapy side effects increased significantly in the psychologist group but not in the SBCN group. Sexual functioning decreased in both groups. Two studies (351 women, very-low quality evidence) measured anxiety and depression. One study reported that anxiety subscale scores and state anxiety scores improved over six months but there was no effect on depression subscale scores in the SBCN group compared to the psychologist group. There was no group-by-time interaction on the anxiety and depression or state anxiety subscales. The other study reported that anxiety and depression scores reduced over the 12-month post-surgery period in the SBCN group; scores were consistently lower in women supported by SBCNs compared to support from a voluntary organisation. SBCN-led telephone interventions delivering follow-up care compared with usual care for women with primary breast cancer Three studies (931 women, moderate-quality evidence) reported general health-related quality of life outcomes. Two studies reported no difference in psychological morbidity scores between SBCN-led follow-up care and standard care at 18 to 24 months. One trial reported no change in feelings of control scores between SBCN-led follow-up care and standard care at 12 months. Two studies (557 women, moderate-quality evidence) reported no between-group difference in cancer-specific quality of life at 18 to 24 months. A SBCN intervention conducted by telephone, as a point-of-need access to specialist care, did not change psychological morbidity compared to routine clinical review at 18 months. Scores for both groups on the breast cancer subscale improved over time, with lower scores at nine and 18 months compared to baseline. The adjusted mean differences between groups at 18 months was 0.7 points in favour of the SBCN intervention (P = 0.058). A second study showed no differences between groups for role and emotional functioning measured using cancer-specific quality of life questionnaires in a SBCN-led telephone intervention compared with standard hospital care, both with and without an educational group programme at 12 months. At 12 months, mean scores were 78.4 (SD = 16.2) and 77.7 (SD = 16.2) respectively for SBCN-led telephone and standard hospital follow-up. The 95% confidence interval difference at 12 months was -1.93 to 4.64. Three studies (1094 women, moderate-quality evidence) reported no between-group difference in anxiety between 12 and 60 months follow-up. One of these studies also measured depression and reported no difference in depression scores between groups at five years (anxiety: RR 1.8; 95% CI 0.6 to 5.1; depression: RR 1.7 95% CI 0.4 to 7.2). Four studies (1331 women, moderate-quality evidence) demonstrated high levels of satisfaction with SBCN-led follow-up care by telephone between 12 and 60 months. Psychosocial nursing interventions compared with usual care for women with advanced breast cancer One study (105 women, low-quality evidence) showed no difference in cancer-specific quality of life outcomes at 3 months. AUTHORS' CONCLUSIONS: Evidence suggests that psychosocial interventions delivered by SBCNs for women with primary breast cancer may improve or are at least as effective as standard care and other supportive interventions, during diagnosis, treatment and survivorship. SBCN-led telephone follow-up interventions were equally as effective as standard care, for women with primary breast cancer.