Understanding decision-making for and against oncoplastic breast-conserving surgery as an alternative to a mastectomy in early breast cancer: UK ANTHEM qualitative study.

BACKGROUND: Oncoplastic breast-conserving surgery may allow women with early breast cancer to avoid a mastectomy, but many women undergo more extensive surgery, even when breast-conserving options are offered. The aim of the ANTHEM qualitative study was to explore factors influencing women's surgical decision-making for and against oncoplastic breast-conserving surgery. METHODS: Semi-structured interviews were conducted with a purposive sample of women who had received either oncoplastic breast-conserving surgery or a mastectomy with or without immediate breast reconstruction to explore their rationale for procedure choice. Interviews were transcribed verbatim and analysed thematically. Trial registration number: ISRCTN18238549. RESULTS: A total of 27 women from 12 centres were interviewed. Out of these, 12 had chosen oncoplastic breast-conserving surgery and 15 had chosen a mastectomy with or without immediate breast reconstruction. Overwhelmingly, women's decisions were guided by their surgical teams. Decision-making for and against oncoplastic breast-conserving surgery was influenced by three key inter-related factors: perceptions of oncological safety; the importance of maintaining/restoring femininity and body image; and practical issues. Oncological safety was paramount. Women who reported feeling reassured that oncoplastic breast-conserving surgery was oncologically safe were happy to choose this option. Those who were not reassured were more likely to opt for a mastectomy, as a perceived 'safer' option. Most women wished to maintain/restore femininity, with the offer of immediate breast reconstruction essential to make a mastectomy an acceptable option. Practical issues such as the perceived magnitude of the surgery were a lesser concern. CONCLUSION: Decision-making is complex and heavily influenced by the surgical team. High-quality, accurate information about surgical options, including appropriate reassurance about the short- and long-term oncological safety of oncoplastic breast-conserving surgery is vital if women are to make fully informed decisions.

Quality improvement interventions to increase the uptake of magnesium sulphate in preterm deliveries for the prevention of cerebral palsy (PReCePT study): a cluster randomised controlled trial.

OBJECTIVE: To compare two quality improvement (QI) interventions to improve antenatal magnesium sulphate (MgSO4 ) uptake in preterm births for the prevention of cerebral palsy. DESIGN: Unblinded cluster randomised controlled trial. SETTING: Academic Health Sciences Network, England, 2018. SAMPLE: Maternity units with ≥10 preterm deliveries annually and MgSO4 uptake of ≤70%; 40 (27 NPP, 13 enhanced support) were included (randomisation stratified by MgSO4 uptake). METHODS: The National PReCePT Programme (NPP) gave maternity units QI materials (clinical guidance, training), regional support, and midwife backfill funding. Enhanced support units received this plus extra backfill funding and unit-level QI coaching. MAIN OUTCOME MEASURES: MgSO4 uptake was compared using routine data and multivariable linear regression. Net monetary benefit was estimated, based on implementation costs, lifetime quality-adjusted life-years and societal costs. The implementation process was assessed through qualitative interviews. RESULTS: MgSO4 uptake increased in all units, with no evidence of any difference between groups (0.84 percentage points lower uptake in the enhanced group, 95% CI -5.03 to 3.35). The probability of enhanced support being cost-effective was <30%. NPP midwives gave more than their funded hours for implementation. Units varied in their support needs. Enhanced support units reported better understanding, engagement and perinatal teamwork. CONCLUSIONS: PReCePT improved MgSO4 uptake in all maternity units. Enhanced support did not further improve uptake but may improve teamwork, and more accurately represented the time needed for implementation. Targeted enhanced support, sustainability of improvements and the possible indirect benefits of stronger teamwork associated with enhanced support should be explored further.

Graded exercise therapy compared to activity management for paediatric chronic fatigue syndrome/myalgic encephalomyelitis: pragmatic randomized controlled trial.

The MAGENTA pragmatic parallel groups randomized controlled trial compared graded exercise therapy (GET) with activity management (AM) in treating paediatric myalgic encephalomyelitis or chronic fatigue syndrome (ME/CFS). Children aged 8-17 years with mild/moderate ME/CFS and presenting to NHS specialist paediatric services were allocated at random to either individualised flexible treatment focussing on physical activity (GET, 123 participants) or on managing cognitive, school and social activity (AM, 118 participants) delivered by NHS therapists. The primary outcome was the self-reported short-form 36 physical function subscale (SF-36-PFS) after 6 months, with higher scores indicating better functioning. After 6 months, data were available for 201 (83%) participants who received a mean of 3.9 (GET) or 4.6 (AM) treatment sessions. Comparing participants with measured outcomes in their allocated groups, the mean SF-36-PFS score changed from 54.8 (standard deviation 23.7) to 55.7 (23.3) for GET and from 55.5 (23.1) to 57.7 (26.0) for AM giving an adjusted difference in means of -2.02 (95% confidence interval -7.75, 2.70). One hundred thirty-five participants completed the mean SF-36-PFS at 12 months, and whilst further improvement was observed, the difference between the study groups remained consistent with chance. The two study groups showed similar changes on most of the secondary outcome measures: Chalder Fatigue, Hospital Anxiety and Depression Scale: Depression, proportion of full-time school attended, a visual analogue pain scale, participant-rated change and accelerometer measured physical activity, whether at the 6-month or 12-month assessment. There was an isolated finding of some evidence of an improvement in anxiety in those allocated to GET, as measured by the Hospital Anxiety and Depression Scale at 6 months, with the 12-month assessment, and the Spence Children's Anxiety scale being aligned with that finding. There was weak evidence of a greater risk of deterioration with GET (27%) than with AM (17%; p = 0.069). At conventional UK cost per QALY thresholds, the probability that GET is more cost-effective than AM ranged from 18 to 21%. Whilst completion of the SF-36-PFS, Chalder Fatigue Scale and EQ-5D-Y was good at the 6-month assessment point, it was less satisfactory for other measures, and for all measures at the 12-month assessment.  Conclusion: There was no evidence that GET was more effective or cost-effective than AM in this setting, with very limited improvement in either study group evident by the 6-month or 12-month assessment points.  Trial registration: The study protocol was registered at www.isrctn.com (3rd September 2015; ISRCTN 23962803) before the start of enrolment to the initial feasibility phase.

'Does it matter how old I feel?' The role of subjective age in a psychosocial intervention for improving depressive symptomatology among older adults in Brazil (PROACTIVE).

OBJECTIVES: Depression is a prevalent mental health condition that also often affects older adults. The PROACTIVE psychosocial intervention was developed to reduce depressive symptomatology among older adults within primary care settings in Brazil. An important psychological marker that affects individuals' aging experience relates to how old people feel. Known as subjective age, this marker has been shown to be a risk factor for experiencing greater depressive symptoms if individuals report feeling older than their (chronological) age. In this study, we perform secondary analyses of the PROACTIVE cluster-randomized controlled trial to examine the role of subjective age. METHOD: The sample included 715 Brazilian older adults (74% female, Mage 68.6, SD = 6.9, age range: 60-94 years) randomized to intervention (n = 360, 74% female, Mage 68.4, SD = 6.6, age range: 60-89 years) or control (n = 355, 74% female, Mage 68.9, SD = 7.2, age range: 60-94 years) arms. Here our primary outcome was depressive symptoms at the 8-month follow-up assessed with the 9-item Patient Health Questionnaire (PHQ-9) as a continuous variable. Our previous analyses demonstrated improved recovery from depression at follow-up in the intervention compared with the control arm. RESULTS: Relevant main effects and interactions in regression models for PHQ-9 presented here found that those reporting older subjective age had worse depressive symptoms at follow-up but that they benefitted more from the intervention when initial levels of depression were high. For participants who reported younger subjective ages the intervention showed positive effects that were independent of initial levels of depression. CONCLUSION: Our findings emphasize the importance of investigating possible underlying mechanisms that can help clarify the impact of mental health interventions.

Secondary healthcare costs after mastectomy and immediate breast reconstruction for women with breast cancer in England: population-based cohort study.

BACKGROUND: Immediate breast reconstruction after mastectomy can improve the quality of life for women with breast cancer and rates are increasing. Long-term inpatient costs of care were estimated to understand the impact of different immediate breast reconstruction procedures on healthcare expenditure. METHODS: Hospital Episode Statistics Admitted Patient Care data were used to identify women undergoing unilateral mastectomy and immediate breast reconstruction in English National Health Service hospitals (1 April 2009 to 31 March 2015) and any subsequent procedures performed to revise, replace, or complete the breast reconstruction. Costs were assigned to Hospital Episode Statistics Admitted Patient Care data using the Healthcare Resource Group 2020/21 National Costs Grouper. Generalized linear models were used to estimate mean cumulative costs for five immediate breast reconstruction procedures over 3 and 8 years, adjusting for covariates (age/ethnicity/deprivation). RESULTS: A total of 16 890 women underwent mastectomy and immediate breast reconstruction: implant (5192; 30.7 per cent), expander (2826; 16.7 per cent), autologous latissimus dorsi flap (2372; 14.0 per cent), latissimus dorsi flap with expander/implant (3109; 18.4 per cent), and abdominal free-flap reconstruction (3391; 20.1 per cent). The mean (95 per cent c.i.) cumulative cost was lowest for latissimus dorsi flap with expander/implant reconstruction (€20 103 (€19 582 to €20 625)) over 3 years and highest for abdominal free-flap reconstruction (€27 560 (€27 037 to €28 083)). Over 8 years, expander (€29 140 (€27 659 to €30 621)) and latissimus dorsi flap with expander/implant (€29 312 (€27 622 to €31 003)) reconstructions were the least expensive, while abdominal free-flap reconstruction (€34 536 (€32 958 to €36 113)) remained the most expensive, despite having lower costs for revisions and secondary reconstructions. This was driven primarily by the cost of the index procedure (€5435 (expander reconstruction) to €15 106 (abdominal free-flap reconstruction)). CONCLUSION: Hospital Episode Statistics Admitted Patient Care Healthcare Resource Group data provided a comprehensive longitudinal cost assessment of secondary care. Although abdominal free-flap reconstruction was the most expensive option, higher costs of the index procedure need to be balanced against ongoing long-term costs of revisions/secondary reconstructions, which are higher after implant-based procedures.

Long-term patient-reported outcomes of immediate breast reconstruction after mastectomy for breast cancer: population-based cohort study.

BACKGROUND: Breast reconstruction is offered to improve quality of life for women after mastectomy for breast cancer, but information regarding the long-term patient-reported outcomes of different reconstruction procedures is currently lacking. The Brighter study aimed to evaluate long-term patient-reported outcomes after immediate breast reconstruction (IBR) in a population-based cohort. METHODS: Women who underwent mastectomy with IBR for breast cancer in England between 1 January 2008 and 31 March 2009 were identified from National Health Service Hospital Episode Statistics. Surviving women were invited to complete the BREAST-Q, EQ-5D-5L™, and ICECAP-A at least 12 years after the index procedure. Questionnaires were scored according to developers' instructions and compared by IBR type. RESULTS: Some 1236 women underwent IBR; 343 (27.8 per cent) had 2-stage expander/implant, 630 (51.0 per cent) latissimus dorsi, and 263 (21.3 per cent) abdominal flap reconstructions, with a mean(s.d.) follow-up of 13.3(0.5) years. Women who underwent abdominal flap reconstruction reported higher scores in all BREAST-Q domains than those who had other procedures. These differences remained statistically significant and clinically meaningful after adjusting for age, ethnicity, geographical region, socioeconomic status, smoking, BMI, and complications. The greatest difference was seen in scores for satisfaction with breasts; women who had abdominal flap reconstructions reported scores that were 13.17 (95 per cent c.i. 9.48 to 16.87) points; P < 0.001) higher than those among women who had two-stage expander/implant procedures. Women who underwent latissimus dorsi reconstruction reported significantly more pain/discomfort on the EQ-5D-5L™, but no other differences between procedures were seen. CONCLUSION: Long-term patient-reported outcomes are significantly better following abdominal flap reconstruction than other traditional procedure types. These findings should be shared with women considering IBR to help them make informed decisions about their surgical options.

Short and medium-term effects of the COVID-19 lockdowns on child and parent accelerometer-measured physical activity and sedentary time: a natural experiment.

BACKGROUND: The COVID-19 pandemic has resulted in marked impacts on children's physical activity, with large reductions in moderate-to-vigorous physical activity (MVPA) reported during lockdowns. Previous evidence showed children's activity levels were lower and sedentary time higher immediately post-COVID lockdown, while there was little change in parental physical activity. We need to know if these patterns persist. METHODS: Active-6 is a natural experiment using repeated cross-sectional data conducted in two waves. Accelerometer data were collected on 393 children aged 10-11 and their parents from 23 schools in Wave 1 (June 2021-December 2021), and 436 children and parents from 27 schools in Wave 2 (January 2022-July 2022). These were compared to a pre-COVID-19 comparator group (March 2017-May 2018) of 1,296 children and parents in the same schools. Mean minutes of accelerometer-measured MVPA and sedentary time were derived for week- and weekend-days and compared across waves via linear multilevel models. We also analysed the date of data collection as a time series, to explore temporal patterns via generalised additive mixed models. RESULTS: There was no difference in children's mean MVPA in Wave 2 (weekdays: -2.3 min; 95% CI: -5.9, 1.3 and weekends: 0.6 min; 95% CI: -3.5, 4.6) when compared to the pre-COVID-19 data. Sedentary time remained higher than pre-pandemic by 13.2 min (95% CI:5.3, 21.1) on weekdays. Differences compared to pre-COVID-19 changed over time, with children's MVPA decreasing over winter, coinciding with COVID-19 outbreaks, and only returning to pre-pandemic levels towards May/June 2022. Parents' sedentary time and weekday MVPA was similar to pre-COVID-19 levels, with MVPA higher than pre-pandemic by 7.7 min (95% CI: 1.4, 14.0) on weekends. CONCLUSION: After an initial drop, children's MVPA returned to pre-pandemic levels by July 2022, while sedentary time remained higher. Parents' MVPA remained higher, especially at weekends. The recovery in physical activity is precarious and potentially susceptible to future COVID-19 outbreaks or changes in provision, and so robust measures to protect against future disruptions are needed. Furthermore, many children are still inactive, with only 41% meeting UK physical activity guidelines, and so there is still a need to increase children's physical activity.

The status of active after-school clubs among primary school children in England (UK) after the COVD-19 lockdowns: implications for policy and practice.

BACKGROUND: Children's physical activity in England is more dependent on active clubs after the COVID-19 pandemic. However, it is unclear how the COVID-19 pandemic and related cost-of-living crisis have impacted on active club participation, costs and provision. This mixed-methods natural experiment explored school-based and community-based active clubs after lockdowns, using a unique combination of data sources to highlight implications for policy and practice post-COVID-19. METHODS: Cross-sectional questionnaire data on school and community active clubs were collected from 10-11-year-old children pre-COVID-19 in 2017-18 (N = 1,296; 50 schools), in 2021 (N = 393; 23 schools), and 2022 (N = 463; 27 schools). Club participation and attendance frequency were modelled using logistic and Poisson mixed effects models, adjusted for child age, gender and household education. In 2021 and 2022, parents reported expenditure on community-based clubs and schools provided data on school-based club provision, with data summarised descriptively. Qualitative data were collected in 2021 and 2022, with one-to-one interviews with school staff (N = 18) and parents (N = 43), and twelve child focus groups (N = 92), and analysed using the framework method. RESULTS: School-based active club participation was higher in 2022 compared to pre-pandemic (50% /43%), while community-based club participation was lower (74%/80%). Children attended 0.3 fewer clubs per week. Those from lower education households were less likely to participate in both types of active clubs, and girls less likely to attend community clubs. In 2022, the median cost of community and school club sessions were £6.67 and £3.88 respectively, with 52% of school-based clubs free to parents. Schools offered an average of 3.4 active clubs per week for 10-11-year-olds in 2022, with 34% partly/wholly subsidised. Qualitative analysis highlighted the impact of the cost-of-living crisis and COVID-19 pandemic on family resources, encouraging a shift to more affordable and convenient school-based active clubs, which negatively impacted the community-based active club environment. However, many schools struggled to meet this increased demand. CONCLUSIONS: Findings emphasise the importance for policymakers to support schools to meet increased demand for clubs and community clubs to increase affordable and convenient physical activity opportunities. Targeted support is needed to prevent socioeconomic and gender inequalities.

Screen-viewing behaviours of children before and after the 2020-21 COVID-19 lockdowns in the UK: a mixed methods study.

BACKGROUND: Restrictions during the COVID-19 pandemic have led to increased screen-viewing among children, especially during strict periods of lockdown. However, the extent to which screen-viewing patterns in UK school children have changed post lockdowns is unclear. The aim of this paper is to examine how screen-viewing changed in 10-11-year-old children over the 2020-21 COVID-19 pandemic, how this compares to before the pandemic, and the influences on screen-viewing behaviour. METHODS: This is a mixed methods study with 10-11-year-olds from 50 schools in the Greater Bristol area, UK. Cross-sectional questionnaire data on minutes of weekday and weekend television (TV) viewing and total leisure screen-viewing were collected pre-COVID-19 in 2017-18 (N = 1,296) and again post-lockdowns in 2021 (N = 393). Data were modelled using Poisson mixed models, adjusted for age, gender, household education and seasonality, with interactions by gender and household education. Qualitative data were drawn from six focus groups (47 children) and 21 one-to-one parent interviews that explored screen-viewing behaviour during the pandemic and analysed using the framework method. RESULTS: Total leisure screen-viewing was 11% (95% CI: 12%-18%) higher post-lockdown compared to pre-COVID-19 on weekdays, and 8% (95% CI: 6%-10%) on weekends, equating to around 12-15 min. TV-viewing (including streaming) was higher by 68% (95% CI: 63%-74%) on weekdays and 80% (95% CI: 75%-85%) on weekend days. Differences in both were higher for girls and children from households with lower educational attainment. Qualitative themes reflected an unavoidable increase in screen-based activities during lockdowns, the resulting habitualisation of screen-viewing post-lockdown, and the role of the parent in reducing post-2020/21 lockdown screen-viewing. CONCLUSIONS: Although screen-viewing was higher post-lockdown compared to pre-COVID-19, the high increases reported during lockdowns were not, on average, sustained post-lockdown. This may be attributed to a combination of short-term fluctuations during periods of strict restrictions, parental support in regulating post-lockdown behaviour and age-related, rather than COVID-19-specific, increases in screen-viewing. However, socio-economic differences in our sample suggest that not all families were able to break the COVID-19-related adoption of screen-viewing, and that some groups may need additional support in managing a healthy balance of screen-viewing and other activities following the lockdowns.

The new normal for children's physical activity and screen viewing: a multi-perspective qualitative analysis of behaviours a year after the COVID-19 lockdowns in the UK.

BACKGROUND: The COVID-19 pandemic significantly impacted children's physical activity. Recent evidence indicated children's accelerometer-measured physical activity levels have, on average, returned to near pre-pandemic levels in 2022, though sedentary behaviour remains higher. However, insufficient physical activity levels among children continues to be a critical public health issue in the UK, with only 41% meeting physical activity guidelines. This study aimed to provide in-depth analysis of how the pandemic has shaped children's physical activity patterns beyond the short-term periods following lockdowns and identify the new challenges to engaging children in physical activity. METHODS: One-to-one interviews with parents (n = 22), school staff (n = 9), and six focus groups with children aged 10-11 years (n = 45) were conducted between February and July 2022. Topics explored changes to children's physical activity and sedentary behaviour patterns, including screen-viewing, and factors influencing any changes. The framework method was used for analysis. RESULTS: Five themes were generated. Theme 1 described residual lockdown habits, including increased screen-viewing within the home, while activities outside the home continued to feel less spontaneous. Theme 2 highlighted an interrupted development of social, emotional, and physical skills among children compared to what would be expected pre-pandemic. This coincided with Theme 3 which reflected increased mental health challenges among families, creating complex barriers to children's physical activity. A new normal for child physical activity was evoked and explored in Theme 4, with greater dependence on structured and organised activities. However, Theme 5 highlighted that girls and children with lower socio-economic position may be especially at risk of decreased physical activity. CONCLUSIONS: There is a new normal for children's physical activity that is characterised by increased dependence on structured and organised physical activities, such as active clubs, and less on unstructured and spontaneous physical activities, such as physical play. While this may suit many children, girls and children from lower socio-economic households face barriers to participating in the new normal. It is important that affordable and equitable opportunities are provided to all children to prevent physical activity and health inequalities.

Protocol to evaluate the effectiveness and cost-effectiveness of an environmental nutrition and physical activity intervention in nurseries (Nutrition and Physical Activity Self Assessment for Child Care - NAP SACC UK): a multicentre cluster randomised controlled trial.

BACKGROUND: One in seven UK children have obesity when starting school, with higher prevalence associated with deprivation. Most pre-school children do not meet UK recommendations for physical activity and nutrition. Formal childcare settings provide opportunities to deliver interventions to improve nutritional quality and physical activity to the majority of 3-4-year-olds. The nutrition and physical activity self-assessment for childcare (NAP SACC) intervention has demonstrated effectiveness in the USA with high acceptability in the UK. The study aims to evaluate the effectiveness and cost-effectiveness of the NAP SACC UK intervention to increase physical activity, reduce sedentary time and improve nutritional intake. METHODS: Multi-centre cluster RCT with process and economic evaluation. Participants are children aged 2 years or over, attending UK early years settings (nurseries) for ≥ 12 h/week or ≥ 15 h/week during term time and their parents, and staff at participating nurseries. The 12-month intervention involves nursery managers working with a Partner (public health practitioner) to self-assess policies and practices relating to physical activity and nutrition; nursery staff attending one physical activity and one nutrition training workshop and setting goals to be achieved within 6 months. The Partner provides support and reviews progress. Nursery staff receive a further workshop and new goals are set, with Partner support for a further 6 months. The comparator is usual practice. Up to 56 nurseries will be stratified by area and randomly allocated to intervention or comparator arm with minimisation of differences in level of deprivation. PRIMARY OUTCOMES: accelerometer-assessed mean total activity time on nursery days and average total energy (kcal) intake per eating occasion of lunch and morning/afternoon snacks consumed within nurseries. SECONDARY OUTCOMES: accelerometer-assessed mean daily minutes of moderate-to-vigorous physical activity and sedentary time per nursery day, total physical activity on nursery days compared to non-nursery days, average serving size of lunch and morning/afternoon snacks in nursery per day, average percentage of core and non-core food in lunch and morning/afternoon snacks, zBMI, proportion of children who are overweight/obese and child quality-of-life. A process evaluation will examine fidelity, acceptability, sustainability and context. An economic evaluation will compare costs and consequences from the perspective of the local government, nursery and parents. TRIAL REGISTRATION: ISRCTN33134697, 31/10/2019.

The identification of economically relevant health and social care services for mental disorders in the PECUNIA project.

BACKGROUND: Health economic research is still facing significant problems regarding the standardization and international comparability of health care services. As a result, comparative effectiveness studies and cost-effectiveness analyses are often not comparable. This study is part of the PECUNIA project, which aimed to improve the comparability of economic evaluations by developing instruments for the internationally standardized measurement and valuation of health care services for mental disorders. The aim of this study was to identify internationally relevant services in the health and social care sectors relevant for health economic studies for mental disorders. METHODS: A systematic literature review on cost-of-illness studies and economic evaluations was conducted to identify relevant services, complemented by an additional grey literature search and a search of resource use measurement (RUM) questionnaires. A preliminary long-list of identified services was explored and reduced to a short-list by multiple consolidation rounds within the international research team and an external international expert survey in six European countries. RESULTS: After duplicate removal, the systematic search yielded 15,218 hits. From these 295 potential services could be identified. The grey literature search led to 368 and the RUM search to 36 additional potential services. The consolidation process resulted in a preliminary list of 186 health and social care services which underwent an external expert survey. A final consolidation step led to a basic list of 56 services grouped into residential care, daycare, outpatient care, information for care, accessibility to care, and self-help and voluntary care. CONCLUSIONS: The initial literature searches led to an extensive number of potential service items for health and social care. Many of these items turned out to be procedures, interventions or providing professionals rather than services and were removed from further analysis. The resulting list was used as a basis for typological coding, the development of RUM questionnaires and corresponding unit costs for international mental health economic studies in the PECUNIA project.

Accelerometer-measured physical activity and sedentary time among children and their parents in the UK before and after COVID-19 lockdowns: a natural experiment.

BACKGROUND: Restrictions due to the coronavirus disease 2019 (COVID-19) pandemic reduced physical activity provision for both children and their parents. Recent studies have reported decreases in physical activity levels during lockdown restrictions, but these were largely reliant on self-report methods, with data collected via unrepresentative self-report surveys. The post-pandemic impacts on children's activity levels remain unknown. A key question is how active children become once lockdown restrictions are lifted. METHODS: Active-6 is a repeated cross-sectional natural experiment. Accelerometer data from 1296 children aged 10-11 and their parents were collected in 50 schools in the Greater Bristol area, UK in March 2017-May 2018 (pre-COVID-19 comparator group), and compared to 393 children aged 10-11 and parents in 23 of the same schools, collected in May-December 2021. Mean minutes of accelerometer-measured moderate-to-vigorous physical activity (MVPA) were derived for weekdays and weekend and compared pre- and post-lockdown via linear multilevel models. RESULTS: After adjusting for seasonality, accelerometer wear time and child/parent demographics, children's mean weekday and weekend MVPA were 7.7 min (95% CI: 3.5 to 11.9) and 6.9 min (95% CI: 0.9 to 12.9) lower in 2021 than in 2018, respectively, while sedentary time was higher by 25.4 min (95% CI: 15.8 to 35.0) and 14.0 min (95% CI: 1.5 to 26.5). There was no evidence that differences varied by child gender or household education. There was no significant difference in parents' MVPA or sedentary time, either on weekdays or weekends. CONCLUSIONS: Children's MVPA was lower by 7-8 min/day in 2021 once restrictions were lifted than before the pandemic for all groups, on both weekdays and weekends. Previous research has shown that there is an undesirable age-related decline in children's physical activity. The 8-min difference reported here would be broadly comparable to the decline that would have previously been expected to occur over a three-year period. Parents' physical activity was similar to pre-pandemic levels. Our results suggest that despite easing of restrictions, children's activity levels have not returned to pre-pandemic levels. There is an urgent need to understand why these changes have occurred and how long they are maintained.

A multi-perspective qualitative exploration of the reasons for changes in the physical activity among 10-11-year-old children following the easing of the COVID-19 lockdown in the UK in 2021.

BACKGROUND: Active-6 is exploring how the COVID-19 pandemic has impacted physical activity behaviour among Year 6 children (aged 10-11 years) and their parents in Southwest England. Initial findings from the Active-6 project have shown a 7-8 min decrease in moderate-to-vigorous physical activity and an increase in sedentary behaviour among children following the easing of restrictions in the UK in latter half of 2021. This finding suggests that the pandemic has had a persistent impact on child physical activity behaviour. This paper explored the possible mechanisms behind these changes. METHODS: Interviews with parents (n = 21), members of school staff (n = 9) and focus groups with children aged 10-11 years (n = 47) were conducted between August and December 2021 to discuss the impact of the pandemic on child physical activity behaviour. The framework method was used for analysis. RESULTS: Five themes spanning two key stages of the pandemic were described. Three themes related to the period of lockdowns and fluctuating restrictions (March 2020 - April 2021). These included: Theme 1) Lockdown: A short-lived adventure; Theme 2) Access to facilities during restrictions; and Theme 3) The importance of the parent. A further two themes were identified related to the period following the gradual easing of restrictions in April 2021. These included: Theme 4) An overwhelming return to normal; and Theme 5) Reopening fatigue. CONCLUSIONS: The analysis suggested that feelings of novelty experienced during the initial stages of lockdown waned as restrictions were prolonged, creating an increasingly challenging period for parents and their children. However, during periods of restrictions, the importance of parental encouragement and access to appropriate facilities in the local and home environment helped facilitate physical activity. Following the easing of COVID-19 restrictions, emotional overwhelm and physical fatigue among children, stemming from a sedentary and socially isolated life in lockdown and other restrictions, were key contributors to the decreased moderate to vigorous physical activity and increased sedentary behaviour that was observed in a related quantitative study.

Depressive and subthreshold depressive symptomatology among older adults in a socioeconomically deprived area in Brazil.

Depressive and subthreshold depressive symptomatology are common but often neglected in older adults. OBJECTIVE: This study aimed to assess rates of depressive and subthreshold depressive symptomatology, and the characteristics associated, among older adults living in a socioeconomically deprived area of Brazil. METHODS: This study is part of the PROACTIVE cluster randomised controlled trial. 3356 adults aged 60+ years and registered in 20 primary health clinics were screened for depressive symptomatology with the Patient Health Questionnaire-9 (PHQ-9). Depressive status was classified according to the total PHQ-9 score and the presence of core depressive symptoms (depressed mood and anhedonia) as follows: no depressive symptomatology (PHQ-9 score 0-4, or 5-9 but with no core depressive symptom); subthreshold depressive symptomatology (PHQ-9 score 5-9 and at least one core depressive symptom); and depressive symptomatology (PHQ-9 score ≥ 10). Sociodemographic information and self-reported chronic conditions were collected. Relative risk ratios and 95% CIs were obtained using a multinomial regression model. RESULTS: Depressive and subthreshold depressive symptomatology were present in 30% and 14% of the screened sample. Depressive symptomatology was associated with female gender, low socioeconomic conditions and presence of chronic conditions, whereas subthreshold depressive symptomatology was only associated with female gender and having hypertension. CONCLUSIONS: Depressive and subthreshold depressive symptomatology is highly prevalent in this population registered with primary care clinics. Strategies managed by primary care non-mental health specialists can be a first step for improving this alarming and neglected situation among older adults.

An intervention to improve teacher well-being support and training to support students in UK high schools (the WISE study): A cluster randomised controlled trial.

BACKGROUND: Teachers are at heightened risk of poor mental health and well-being, which is likely to impact on the support they provide to students, and student outcomes. We conducted a cluster randomised controlled trial, to test whether an intervention to improve mental health support and training for high school teachers led to improved mental health and well-being for teachers and students, compared to usual practice. We also conducted a cost evaluation of the intervention. METHODS AND FINDINGS: The intervention comprised (i) Mental Health First Aid training for teachers to support students; (ii) a mental health awareness session; and (iii) a confidential staff peer support service. In total 25 mainstream, non-fee-paying secondary schools stratified by geographical area and free school meal entitlement were randomly allocated to intervention (n = 12) or control group (n = 13) after collection of baseline measures. We analysed data using mixed-effects repeated measures models in the intention-to-treat population, adjusted for stratification variables, sex, and years of experience. The primary outcome was teacher well-being (Warwick-Edinburgh Mental Well-being Scale). Secondary outcomes were teacher depression, absence, and presenteeism, and student well-being, mental health difficulties, attendance, and attainment. Follow-up was at months 12 (T1) and 24 (T2). We collected process data to test the logic model underpinning the intervention, to aid interpretation of the findings. A total of 1,722 teachers were included in the primary analysis. Teacher well-being did not differ between groups at T2 (intervention mean well-being score 47.5, control group mean well-being score 48.4, adjusted mean difference -0.90, 95% CI -2.07 to 0.27, p = 0.130). The only effect on secondary outcomes was higher teacher-reported absence among the intervention group at T2 (intervention group median number of days absent 0, control group median number of days absent 0, ratio of geometric means 1.04, 95% CI 1.00 to 1.09, p = 0.042). Process measures indicated little change in perceived mental health support, quality of relationships, and work-related stress. The average cost of the intervention was £9,103 per school. The study's main limitations were a lack of blinding of research participants and the self-report nature of the outcome measures. CONCLUSIONS: In this study, we observed no improvements to teacher or student mental health following the intervention, possibly due to a lack of impact on key drivers of poor mental health within the school environment. Future research should focus on structural and cultural changes to the school environment, which may be more effective at improving teacher and student mental health and well-being. TRIAL REGISTRATION: www.isrctn.com ISRCTN95909211.

Effectiveness and cost-effectiveness of the PLAN-A intervention, a peer led physical activity program for adolescent girls: results of a cluster randomised controlled trial.

BACKGROUND: Physical activity is associated with improved health. Girls are less active than boys. Pilot work showed that a peer-led physical activity intervention called PLAN-A was a promising method of increasing physical activity in secondary school age girls. This study examined the effectiveness and cost-effectiveness of the PLAN-A intervention. METHODS: We conducted a cluster randomised controlled trial with Year 9 (13-14 year old) girls recruited from 20 secondary schools. Schools were randomly assigned to the PLAN-A intervention or a non-intervention control group after baseline data collection. Girls nominated students to be peer leaders. The top 18 % of girls nominated by their peers in intervention schools received three days of training designed to prepare them to support physical activity. Data were collected at two time points, baseline (T0) and 5-6 months post-intervention (T1). Participants wore an accelerometer for seven days to assess the primary outcome of mean weekday minutes of moderate-to-vigorous physical activity (MVPA). Multivariable mixed effects linear regression was used to estimate differences in the primary outcome between the two arms on an Intention-to-Treat (ITT) basis. Resource use and quality of life were measured and a within trial economic evaluation from a public sector perspective was conducted. RESULTS: A total of 1558 girls were recruited to the study. At T0, girls in both arms engaged in an average of 51 min of MVPA per weekday. The adjusted mean difference in weekday MVPA at T1 was - 2.84 min per day (95 % CI = -5.94 to 0.25) indicating a slightly larger decline in weekday MVPA in the intervention group. Results were broadly consistent when repeated using a multiple imputation approach and for pre-specified secondary outcomes and sub-groups. The mean cost of the PLAN-A intervention was £2817 per school, equivalent to £31 per girl. Economic analyses indicated that PLAN-A did not lead to demonstrable cost-effectiveness in terms of cost per unit change in QALY. CONCLUSIONS: This study has shown that the PLAN-A intervention did not result in higher levels of weekday MVPA or associated secondary outcomes among Year 9 girls. The PLAN-A intervention should not be disseminated as a public health strategy. TRIAL REGISTRATION: ISRCTN14539759 -31 May, 2018.

Content of Health Economics Analysis Plans (HEAPs) for Trial-Based Economic Evaluations: Expert Delphi Consensus Survey.

OBJECTIVES: Health economics analysis plans (HEAPs) currently lack consistency, with uncertainty surrounding appropriate content. We aimed to develop a list of essential items that should be included in HEAPs for economic evaluations conducted alongside randomized trials. METHODS: A list of potential items for inclusion was developed by examining existing HEAPs. An electronic Delphi survey was conducted among professional health economists. Respondents were asked to rate potential items from 1 (least important) to 9 (most important), suggest additional items, and comment on proposed items (round 1). A second survey (round 2) was emailed to participants, including the participant's own scores from round 1 along with summary results from the whole panel; participants were asked to rerate each item. Consensus criteria for inclusion in the final list were predefined as >70% of participants rating an item 7-9 and <15% rating it 1-3 after round 2. A final item selection meeting was held to scrutinize the results and adjudicate on items lacking consensus. RESULTS: 62 participants completed round 1 of the survey. The initial list included 72 potential items; all 72 were carried forward to round 2, and no new items were added. 48 round 1 respondents (77.4%) completed round 2 and reached consensus on 53 items. At the final meeting, the expert panel (n = 9) agreed that 58 items should be included in the essential list, moved 9 items to an optional list, and dropped 5 items. CONCLUSIONS: Via expert consensus opinion, this study identified 58 items that are considered essential in a HEAP.

Use of prophylactic mesh during initial stoma creation to prevent parastomal herniation: a systematic review and meta-analysis of randomised controlled trials.

AIM: Parastomal hernia (PSH) is a common complication following stoma creation. Previous reviews found mesh reinforcement during initial stoma creation beneficial in reducing PSH incidence. Since then, several multicentre randomised controlled trials (RCTs) produced widely ranging results rendering previous findings debatable. This current review assessed whether combining the latest larger multicentre RCTs would alter the previous findings. METHODS: The Cochrane Library, MEDLINE and Embase were searched from the respective dates of inception until 15 January 2021. RCTs were included if they compared mesh with no mesh during initial stoma creation in adult patients to prevent PSH. Included RCTs were summarised narratively and meta-analysed to estimate the relative risk (RR) of PSH incidence (primary analysis), peristomal complications and PSH repair (secondary analyses). Several subgroup analyses were performed, including mesh type (synthetic/biologic), surgical technique (open/laparoscopic) and mesh position (sublay/intraperitoneal). RESULTS: Thirteen RCTs were included in the primary meta-analysis (1070 patients); PSH incidence was reduced in patients with mesh compared with patients without mesh at maximal follow-up (RR = 0.54; 95% CI 0.39-0.77; I2  = 67%; P < 0.01). The number of PSH repairs was fewer in patients who had mesh (RR = 0.63; 0.35-1.14; I2  = 6%; P = 0.39), with no difference in peristomal complications (RR = 0.96; 0.55-1.70; I2  = 0%; P = 0.71), comparing with no mesh. Subgroup analyses suggested that placing synthetic mesh using an open sublay technique might be more beneficial. CONCLUSIONS: Prophylactic mesh reinforcement during initial stoma creation reduces PSH incidence and potentially its repair, without an increase in peristomal complications. However, substantial heterogeneity among included RCTs limits confidence in the results.

A semi-Markov model comparing the lifetime cost-effectiveness of mesh prophylaxis to prevent parastomal hernia in patients undergoing end colostomy creation for rectal cancer.

AIM: Parastomal hernia (PSH) is a common problem following colostomy. Using prophylactic mesh during end colostomy creation may reduce PSH incidence, but concerns exist regarding the optimal type of mesh, potential long-term complications, and cost-effectiveness of its use. We evaluated the cost-effectiveness of mesh prophylaxis to prevent PSH in patients undergoing end colostomy creation for rectal cancer. METHODS: We developed a decision-analytical model, stratified by rectal cancer stages I-IV, to estimate the lifetime costs, quality-adjusted life-years (QALYs) and net monetary benefits (NMBs) of synthetic, biologic and no mesh from a UK NHS perspective. We pooled the mesh-related relative risks of PSH from 13 randomised controlled trials (RCTs) and superimposed these on the baseline (no mesh) risk from a population-based cohort. Uncertainty was assessed in sensitivity analyses. RESULTS: Synthetic mesh was less costly and more effective than biologic and no mesh to prevent PSH for all rectal cancer stages. At the willingness-to-pay threshold of £20,000/QALY, the incremental NMBs (95% CI) ranged between £1,706 (£1,692 to £1,720) (stage I) and £684 (£678 to £690) (stage IV) for synthetic versus no mesh, and £2,038 (£1,997 to £2,079) (stage I) and £1,671 (£1,653 to £1,689) (stage IV) for synthetic versus biologic mesh. Synthetic mesh was more cost-effective than no mesh unless the relative risk of PSH was ≥0.95 for stages I-III and ≥0.93 for stage IV. [Correction added on 05 October 2021 after first online publication: The estimation of health outcomes (QALYs) for all three interventions evaluated (synthetic mesh; biologic mesh; no mesh) have been corrected in this version.] CONCLUSIONS: Synthetic mesh was the most cost-effective strategy to prevent the formation of PSH in patients after end colostomy for any rectal cancer stage; however, conclusions are dependent on which subset of RCTs are considered to provide the most robust evidence.