A physical activity, nutrition and oral health intervention in nursery settings: process evaluation of the NAP SACC UK feasibility cluster RCT.

BACKGROUND: The nutrition and physical activity self-assessment for childcare (NAP SACC) intervention has demonstrated effectiveness in the USA. A feasibility randomised controlled trial was conducted in England to adapt the intervention to the UK context. An embedded process evaluation focused on three key questions. 1. Was it feasible and acceptable to implement the intervention as planned? 2. How did the intervention affect staff and parent mediators? 3. Were the trial design and methods acceptable? METHODS: Twelve nurseries in south-west England were recruited and randomised to intervention or control. The intervention comprised: NAP SACC UK Partner (Health Visitor) support to nurseries to review practice and policies against best practice, and then set goals to improve physical activity, nutrition and oral health; two staff training workshops; and a web-based parent support element. The process evaluation comprised: observations of Partner training (n = 1), Partner/manager meetings (n = 5) and staff workshops (n = 10); semi-structured interviews with Partners (n = 4), managers (n = 12), staff (n = 4) and parents (n = 20); analysis of self-assessment forms, goal setting forms and Partner logbooks; and assessment of staff and parent knowledge, motivation and self-efficacy mediators. RESULTS: Overall, NAP SACC UK was feasible to implement and acceptable to nursery staff, managers, Partners and parents. The intervention was implemented as planned in five of the six intervention nurseries. Partners and managers appreciated the opportunity to review and improve nursery practices and valued the relationship forged between them. Staff rated the training workshops highly, despite attending outside of working hours. Most goals set by nurseries were achieved. However, Partners raised concerns about Health Visitors' capacity to deliver the intervention in any subsequent roll out. Mediator scores improved in all but two areas in intervention staff and parents, with decreases or minimal changes in the control group. The web-based parent element was not well used and should be removed from any subsequent trial. The trial methods were acceptable to managers, staff, Partners and parents. CONCLUSIONS: Implementing and evaluating a physical activity and nutrition intervention in nursery settings is feasible and acceptable. A full RCT of NAP SACC UK (with appropriate modifications) is warranted. TRIAL REGISTRATION: ISRCTN16287377 (10 Apr 2015).

Association of diet in nurseries and physical activity with zBMI in 2-4-year olds in England: a cross-sectional study.

BACKGROUND: Childhood obesity tracks into adulthood with detrimental effects on health. We aimed to examine the relationships of diet in childcare settings and daily physical activity (PA) of preschoolers with body mass index z-score (z-BMI). METHODS: We conducted a cross-sectional study of 150 children aged 2-4-years participating in the Nutrition and Physical Activity Self-Assessment for Child Care (NAP SACC) UK study to examine the associations of their diet in childcare settings and daily PA with z-BMI. Dietary intake was observed and recorded by fieldworkers using a validated tick-list food questionnaire and diet quality was assessed based on adherence to Children's Food Trust (CFT) guidelines. PA was measured using accelerometers. We derived z-BMI scores using the UK 1990 and International Obesity Taskforce growth reference charts. Multilevel regression models were used to estimate associations between diet and PA with z-BMI separately, adjusted for age, gender, ethnicity, parental education level and clustering. RESULTS: Among children who consumed one main meal or snack at childcare, 34.4% and 74.3% met the standards on fruits and vegetables and high sugar or fat snacks, respectively. Adherence to CFT guidelines was not associated with zBMI. Only 11.4% of children met recommended UK guidelines of three hours per day of physical activity. Minutes spent in light PA (ß = 0.08, 95% CI = 0.01, 0.15) and active time (ß = 0.07, 95% CI = 0.01, 0.12) were positively associated with UK 1990 zBMI scores. CONCLUSIONS: The low proportion of children meeting the standards on fruits and vegetables and high sugar or fat snacks and recommended physical activity levels highlight the need for more work to support nurseries and parents to improve preschool children's diet and activity. In our exploratory analyses, we found children with higher zBMI were more physically active which could be attributed to fat-free mass or chance finding and so requires replication in a larger study. TRIAL REGISTRATION: ISRCTN16287377 . Registered 12 June 2014.

The Active for Life Year 5 (AFLY5) school-based cluster randomised controlled trial: effect on potential mediators.

BACKGROUND: Active for life year 5 (AFLY5) is a school-based intervention, based on social cognitive theory, which aims to promote healthy levels of physical activity and healthy eating by improving a child's self-efficacy to make healthy choices, their knowledge of how to make such choices and prompting parents to support their children to make healthy choices. Previously published results showed no effect on the three primary outcomes and beneficial effects on three of nine secondary outcomes (time spent screen-viewing at weekends, consumption of snacks and of high energy drinks). This paper aims to determine the effect of the intervention on potential mediators. METHODS: We conducted a cluster RCT of a school-based intervention, with allocation concealed by use of a remote system. The study was undertaken in the South West of England between 2011 and 2013. Participants were school children who were age 8-9 years at baseline assessment and 9-10 years during the intervention. Potential mediators were assessed at the end of the intervention. The intervention consisted of teacher training, provision of all materials required for lessons and homeworks and written materials for school newsletters and parents. The ten potential mediators were child-reported self-efficacy for physical activity and fruit and vegetable consumption, perceived parental logistic support and modelling for their child's physical activity, parental efforts to limit their child's sedentary behaviour and modelling of healthy fruit and vegetable consumption, together with a knowledge assessment. RESULTS: We successfully recruited 60 schools with over 2,221 children; valid data for the 10 mediators were available for 87 % to 96 % of participants. Three of the ten potential mediators were greater in the intervention, compared with the control group: fruit and vegetable self-efficacy 2.2 units (95 % CI: 0.7 to 3.8), assessed on a scale 26 to 130; child-reported maternal limitation of sedentary behaviour 0.5 (0.1 to 0.8), scale 4 to 16; and knowledge 0.5 (0.2, 0.7) scale 0 to 9. Reported maternal limitation of sedentary behaviour and the child's knowledge explained 23 % of the effect of the intervention on reducing time spent on sedentary behaviour at the weekend. There was no effect on other mediators. CONCLUSIONS: Our findings suggest that the effect of the AFLY5 intervention on reducing screen-viewing at weekends was partially mediated by an effect on mothers limiting their child's time spent sedentary and on increasing the child's knowledge about healthy behaviour. However, overall our findings suggest that theory driven interventions, like AFLY5, can fail to influence most potential mediators and this may explain the failure of the intervention to improve most primary and secondary outcomes. TRIAL REGISTRATION: Current Controlled Trials ISRCTN50133740. Registered 17/03/2011.

Intervention fidelity in a school-based diet and physical activity intervention in the UK: Active for Life Year 5.

BACKGROUND: Active for Life Year 5 (AFLY5) is an educational programme for Year 5 children (aged 9-10) designed to increase children's physical activity, decrease sedentary behaviour and increase fruit and vegetable intake. This paper reports findings from a process evaluation embedded within a randomised controlled trial evaluating the programme's effectiveness. It considers the fidelity of implementation of AFLY5 with a focus on three research questions: 1. To what extent was the intervention delivered as planned? 2. In what ways, if any, did the teachers amend the programme? and 3. What were the reasons for any amendments? METHODS: Mixed methods were used including data collection via observation of the intervention delivery, questionnaire, teacher's intervention delivery log and semi-structured interviews with teachers and parents. Qualitative data were analysed thematically and quantitative data were summarised using descriptive statistics. RESULTS: Following training, 42 of the 43 intervention school teachers/teaching staff (98%) were confident they could deliver the nutrition and physical activity lessons according to plan. The mean number of lessons taught was 12.3 (s.d. 3.7), equating to 77% of the intervention. Reach was high with 95% of children in intervention schools receiving lessons. A mean of 6.2 (s.d. 2.6) out of 10 homeworks were delivered. Median lesson preparation time was 10 min (IQR 10-20) and 28% of lessons were reported as having been amended. Qualitative findings revealed that those who amended the lessons did so to differentiate for student ability, update them for use with new technologies and to enhance teacher and student engagement. Teachers endorsed the aims of the intervention, but some were frustrated with having to adapt the lesson materials. Teachers also a reported tendency to delegate the physical activity lessons to other staff not trained in the intervention. CONCLUSIONS: Fidelity of intervention implementation was good but teachers' enthusiasm for the AFLY5 programme was mixed despite them believing that the messages behind the lessons were important. This may have meant that the intervention messages were not delivered as anticipated and explain why the intervention was found not to be effective. TRIAL REGISTRATION: ISRCTN50133740.

'Everyone has heard of it, but no one knows what it is': A qualitative study of patient understandings and experiences of herpes zoster.

BACKGROUND: Shingles (herpes zoster), caused by reactivation of the varicella-zoster virus, is usually diagnosed and managed in primary care. The lifetime risk of shingles in the general population is approximately 30%, and it can have a detrimental effect on quality of life. There has been little qualitative research about patient experience and understanding of shingles. DESIGN AND SETTING: Qualitative interviews with people recruited from primary care in England. METHOD: Qualitative semi-structured remote interviews were undertaken with 29 participants in a randomised controlled trial in primary care in England (ATHENA, ISRCTN14490832). Participants were aged >49 and were diagnosed within six days of shingles rash onset. Interviewees were sampled for diversity in terms of pain, intervention adherence, age, gender, and ethnicity. Data were analysed using reflexive thematic analysis. FINDINGS: Participants' understanding of shingles was limited, particularly pre-diagnosis. Television campaigns about the shingles vaccination programme helped some to recognise the rash. Shingles was understood as a disease with a variable prognosis, resulting in a sense of uncertainty about the significance when diagnosed. Participants reported a range of symptoms which impacted on everyday life. Some people thought their diagnosis was caused by poor mental health or challenging life circumstances, a perception sometimes reinforced by healthcare professionals. Many participants sought meaning in their diagnosis, reflecting upon, and sometimes changing, their life and circumstances. CONCLUSION: Primary care practitioners should be aware of the broad spectrum of patient knowledge, and the potential for better understanding to promote early attendance and treatment, to reduce the impact of shingles.

Comparison of lotions, creams, gels and ointments for the treatment of childhood eczema: the BEE RCT.

Background: Emollients are recommended for children with eczema (atopic eczema/dermatitis). A lack of head-to-head comparisons of the effectiveness and acceptability of the different types of emollients has resulted in a 'trial and error' approach to prescribing. Objective: To compare the effectiveness and acceptability of four commonly used types of emollients for the treatment of childhood eczema. Design: Four group, parallel, individually randomised, superiority randomised clinical trials with a nested qualitative study, completed in 2021. A purposeful sample of parents/children was interviewed at ≈ 4 and ≈ 16 weeks. Setting: Primary care (78 general practitioner surgeries) in England. Participants: Children aged between 6 months and 12 years with eczema, of at least mild severity, and with no known sensitivity to the study emollients or their constituents. Interventions: Study emollients sharing the same characteristics in the four types of lotion, cream, gel or ointment, alongside usual care, and allocated using a web-based randomisation system. Participants were unmasked and the researcher assessing the Eczema Area Severity Index scores was masked. Main outcome measures: The primary outcome was Patient-Oriented Eczema Measure scores over 16 weeks. The secondary outcomes were Patient-Oriented Eczema Measure scores over 52 weeks, Eczema Area Severity Index score at 16 weeks, quality of life (Atopic Dermatitis Quality of Life, Child Health Utility-9 Dimensions and EuroQol-5 Dimensions, five-level version, scores), Dermatitis Family Impact and satisfaction levels at 16 weeks. Results: A total of 550 children were randomised to receive lotion (analysed for primary outcome 131/allocated 137), cream (137/140), gel (130/135) or ointment (126/138). At baseline, 86.0% of participants were white and 46.4% were female. The median (interquartile range) age was 4 (2-8) years and the median Patient-Oriented Eczema Measure score was 9.3 (SD 5.5). There was no evidence of a difference in mean Patient-Oriented Eczema Measure scores over the first 16 weeks between emollient types (global p = 0.765): adjusted Patient-Oriented Eczema Measure pairwise differences - cream-lotion 0.42 (95% confidence interval -0.48 to 1.32), gel-lotion 0.17 (95% confidence interval -0.75 to 1.09), ointment-lotion -0.01 (95% confidence interval -0.93 to 0.91), gel-cream -0.25 (95% confidence interval -1.15 to 0.65), ointment-cream -0.43 (95% confidence interval -1.34 to 0.48) and ointment-gel -0.18 (95% confidence interval -1.11 to 0.75). There was no effect modification by parent expectation, age, disease severity or the application of UK diagnostic criteria, and no differences between groups in any of the secondary outcomes. Median weekly use of allocated emollient, non-allocated emollient and topical corticosteroids was similar across groups. Overall satisfaction was highest for lotions and gels. There was no difference in the number of adverse reactions and there were no significant adverse events. In the nested qualitative study (n = 44 parents, n = 25 children), opinions about the acceptability of creams and ointments varied most, yet problems with all types were reported. Effectiveness may be favoured over acceptability. Parents preferred pumps and bottles over tubs and reported improved knowledge about, and use of, emollients as a result of taking part in the trial. Limitations: Parents and clinicians were unmasked to allocation. The findings may not apply to non-study emollients of the same type or to children from more ethnically diverse backgrounds. Conclusions: The four emollient types were equally effective. Satisfaction with the same emollient types varies, with different parents/children favouring different ones. Users need to be able to choose from a range of emollient types to find one that suits them. Future work: Future work could focus on how best to support shared decision-making of different emollient types and evaluations of other paraffin-based, non-paraffin and 'novel' emollients. Trial registration: This trial is registered as ISRCTN84540529 and EudraCT 2017-000688-34. Funding: This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (HTA 15/130/07) and will be published in full in Health Technology Assessment; Vol. 27, No. 19. See the NIHR Journals Library website for further project information.

One in five children in the UK have eczema, a long-term, itchy, dry skin condition. It can significantly affect both the child and their family. Most children are diagnosed and looked after by their family doctor (general practitioner) and are prescribed moisturisers (also called emollients) to relieve skin dryness and other creams (topical corticosteroids) to control flare-ups. However, there are many different types of emollients and, to our knowledge, limited research to show which is better. In the Best Emollients for Eczema clinical trial, we compared the four main types of moisturisers ­ lotions, creams, gels and ointments. These types vary in their consistency, from thin to thick. We recruited 550 children (most of whom were white and had moderate eczema) and randomly assigned them to use one of the four different types as their main moisturiser for 16 weeks. We found no difference in effectiveness. Parent-reported eczema symptoms, eczema severity and quality of life were the same for all the four types of moisturisers. However, overall satisfaction was highest for lotions and gels. Ointments may need to be used less and cause less stinging. We interviewed 44 parents and 25 children who took part. Opinions of all four types of moisturisers varied. What one family liked about a moisturiser was not necessarily the same for another and preferences were individual to each user. Sometimes there was a tension between how well a moisturiser worked (effectiveness) and how easy it was to use (acceptability). In these cases, effectiveness tended to decide whether or not parents kept using it. People found moisturisers in pumps and bottles easier to use than those in tubs. A number of participants valued the information they were given about how to use moisturisers. Our results suggest that the type of moisturiser matters less than finding one that suits the child and family.

Effectiveness and safety of lotion, cream, gel, and ointment emollients for childhood eczema: a pragmatic, randomised, phase 4, superiority trial.

BACKGROUND: To our knowledge, there are no trials comparing emollients commonly used for childhood eczema. We aimed to compare the clinical effectiveness and safety of the four main emollient types: lotions, creams, gels, and ointments. METHODS: We did a pragmatic, individually randomised, parallel group, phase 4 superiority trial in 77 general practice surgeries in England. Children aged between 6 months and 12 years with eczema (Patient Orientated Eczema Measure [POEM] score >2) were randomly assigned (1:1:1:1; stratified by centre and minimised by baseline POEM score and age, using a web-based system) to lotions, creams, gels, or ointments. Clinicians and parents were unmasked. The initial emollient prescription was for 500 g or 500 mL, to be applied twice daily and as required. Subsequent prescriptions were determined by the family. The primary outcome was parent-reported eczema severity over 16 weeks (weekly POEM), with analysis as randomly assigned regardless of adherence, adjusting for baseline and stratification variables. Safety was assessed in all randomly assigned participants. This trial was registered with the ISRCTN registry, ISRCTN84540529. FINDINGS: Between Jan 19, 2018, and Oct 31, 2019, 12 417 children were assessed for eligibility, 550 of whom were randomly assigned to a treatment group (137 to lotion, 140 to cream, 135 to gel, and 138 to ointment). The numbers of participants who contributed at least two POEM scores and were included in the primary analysis were 131 in the lotion group, 137 in the cream group, 130 in the gel group, and 126 in the ointment group. Baseline median age was 4 years (IQR 2-8); 255 (46%) participants were girls, 295 (54%) were boys; 473 (86%) participants were White; and the mean POEM score was 9·3 (SD 5·5). There was no difference in eczema severity between emollient types over 16 weeks (global p value=0·77), with adjusted POEM pairwise differences of: cream versus lotion 0·42 (95% CI -0·48 to 1·32), gel versus lotion 0·17 (-0·75 to 1·09), ointment versus lotion -0·01 (-0·93 to 0·91), gel versus cream -0·25 (-1·15 to 0·65), ointment versus cream -0·43 (-1·34 to 0·48), and ointment versus gel -0·18 (-1·11 to 0·75). This result remained unchanged following multiple imputation, sensitivity, and subgroup analyses. The total number of adverse events did not significantly differ between the treatment groups (lotions 49 [36%], creams 54 [39%], gels 54 [40%], and ointments 48 [35%]; p=0·79), although stinging was less common with ointments (12 [9%] of 138 participants) than lotions (28 [20%] of 137), creams (24 [17%] of 140), or gels (25 [19%] of 135). INTERPRETATION: We found no difference in effectiveness between the four main types of emollients for childhood eczema. Users need to be able to choose from a range of emollients to find one that they are more likely to use effectively. FUNDING: National Institute for Health and Care Research.

Identification of novel testing matrices for African swine fever surveillance.

African swine fever (ASF) is a devastating viral disease of pigs and wild boar, and it threatens global food security. We aimed to identify suitable sample matrices for use in ASF surveillance programs. Six pigs inoculated with ASFV were sampled at postmortem. Blood, bone marrow, ear biopsies, and oral, nasal, and rectal swabs were taken from all pigs. All samples were analyzed using 3 real-time PCR (rtPCR) assays and a LAMP assay. ASFV was detected at > 107 genome copies/mL in blood; bone marrow was found to provide the highest viral load. Ct values provided by the rtPCR assays were correlated, and ASFV was detected in all oral, nasal, and rectal swabs and in all ear biopsy samples irrespective of the location from which they were taken. The LAMP assay had lower sensitivity, and detected ASFV in 54 of 66 positive samples, but delivered positive results within 17 min. We identified additional sample matrices that can be considered depending on the sampling situation: bone marrow had a high probability of detection, which could be useful for decomposed carcasses. However, ear biopsies provide an appropriate, high-throughput sample matrix to detect ASFV and may be useful during surveillance programs.

Preoperative VolumE Replacement therapy in DIabetic patients undergoing coronary artery bypass grafting surgery: results from an open parallel group randomized Controlled Trial (VeRDiCT).

OBJECTIVES: To investigate the effect of preoperative volume replacement therapy (VRT) on renal function, health outcome and time to fitness for discharge in diabetic patients undergoing coronary artery bypass grafting (CABG). METHODS: In 2 parallel randomized controlled trials, diabetic patients were allocated to preoperative VRT (1 ml/kg/h of Hartmann's solution for 12 h) or usual care. Primary outcome was time to fitness for discharge. Secondary outcomes included acute kidney injury, postoperative complications, patient-reported quality of life (QoL), hospital resource use and markers of renal, cardiac and inflammatory injury. RESULTS: In total, 169 patients were randomized (84 VRT, 85 usual care; mean age 64 years; 88% male). Time to fitness for discharge was similar between groups [median 6 days; interquartile range 5.0-9.0 in both groups; hazard ratio 0.95, 95% confidence interval (CI) 0.65-1.38; P = 0.78]. Postoperative acute kidney injury was not statistically different (VRT: 27.7% vs usual care: 18.8%, odds ratio 1.72, 95% CI 0.82-3.59; P = 0.15). Estimated glomerular filtration rate (mean difference -0.92, 95% CI -4.18 to 2.25; P = 0.56), microalbumin/creatinine ratio [geometric mean ratio (GMR) 1.16, 95% CI 0.94-1.42; P = 0.16], N-acetyl-beta-d-glucosaminidase (GMR 1.08, 95% CI 0.83-1.40; P = 0.57), C-reactive protein (GMR 1.00, 95% CI 0.88-1.13; P = 0.94), troponin T (Trop-T; GMR 1.18, 95% CI 0.78-1.79; P = 0.39) and other secondary health outcomes were similar between groups. QoL improved in both groups at 3 months with no difference observed. CONCLUSIONS: The use of preoperative VRT is not superior to usual care in diabetic patients undergoing CABG. CLINICAL TRIAL REGISTRATION NUMBER: ISRCTN02159606.

Best emollients for eczema (BEE) - comparing four types of emollients in children with eczema: protocol for randomised trial and nested qualitative study.

INTRODUCTION: Atopic dermatitis/eczema affects around 20% of children and is characterised by inflamed, dry, itchy skin. Guidelines recommend 'leave-on' emollients that are applied directly to the skin to add or trap moisture and used regularly, they can soothe, enhance the skin barrier and may prevent disease 'flares'. However, the suitability of the many different emollients varies between people and there is little evidence to help prescribers and parents and carers decide which type to try first. METHODS AND ANALYSIS: Design: pragmatic, multicentre, individually randomised, parallel group superiority trial of four types of emollient (lotions, creams, gel or ointments). SETTING: general practitioner surgeries in England. PARTICIPANTS: children aged over 6 months and less than 12 years with mild-to-severe eczema and no known sensitivity to study emollients. INTERVENTIONS: study-approved lotion, cream, gel or ointment as the only leave-on emollient for 16 weeks, with directions to apply twice daily and as required. Other treatments, such as topical corticosteroids, used as standard care. FOLLOW-UP: 52 weeks. PRIMARY OUTCOME: validated patient-orientated eczema measure measured weekly for 16 weeks. SECONDARY OUTCOMES: eczema signs (Eczema Area Severity Index) by masked researcher, treatment use, parent satisfaction, adverse events, child and family quality of life (Atopic Dermatitis Quality of Life, Child Health Utility 9D and Dermatitis Family Impact). SAMPLE SIZE: 520 participants (130 per group). ANALYSIS: intention-to-treat using linear mixed models for repeated measures.Nested qualitative study: audio-recording of sample of baseline appointments and up to 60 interviews with participants at 4 and 16 weeks, interviews to be transcribed and analysed thematically. ETHICS AND DISSEMINATION: Ethics approval granted by the NHS REC (South West - Central Bristol Research Ethics Committee 17/SW/0089). Findings will be presented at conferences, published in open-access peer-reviewed journals and the study website; and summaries shared with key stakeholders. TRIAL REGISTRATION NUMBER: ISRCTN84540529.

Long-term effects of the Active for Life Year 5 (AFLY5) school-based cluster-randomised controlled trial.

OBJECTIVE: To investigate the long-term effectiveness of a school-based intervention to improve physical activity and diet in children. DESIGN: Cluster-randomised controlled trial. SETTING: 60 primary schools in the southwest of England. PARTICIPANTS: Primary school children who were aged 8-9 years at recruitment, 9-10 years during the intervention and 10-11 years at the long-term follow-up assessment. INTERVENTION: Teacher training, provision of lesson and child-parent interactive homework plans and teaching materials. MAIN OUTCOME MEASURES: Primary outcomes were accelerometer-assessed minutes of moderate to vigorous physical activity (MVPA) per day, accelerometer-assessed minutes of sedentary behaviour per day and reported daily consumption of servings of fruit and vegetables. RESULTS: 60 schools with 2221 eligible children were recruited. As in the previously published assessment immediately after the end of the intervention, none of the three primary outcomes differed between children in schools allocated to the intervention, compared with those in control schools at the end of the long-term follow-up (1 year after the end of the intervention). Differences in secondary outcomes were consistent with those at the immediate follow-up, with no evidence that these had diminished over time. Comparing intervention with control schools, the difference in mean child-reported screen viewing at the weekend was -16.03 min (95% CI -32.82 to 0.73), for servings of snacks per day, the difference was -0.11 (95% CI -0.39 to 0.06), in servings of high-energy drinks per day -0.20 (95% CI -0.39 to -0.01) and in servings of high-fat foods per day -0.12 (95% CI -0.39 to 0.00). None of these reached our predefined level of statistical significance, especially after accounting for multiple testing. CONCLUSIONS: School-based curriculum interventions alone are unlikely to have a major public health impact on children's diet and physical activity. TRIAL REGISTRATION NUMBER: ISRCTN50133740, Post-results.

Coronary artery bypass grafting in high-RISk patients randomised to off- or on-Pump surgery: a randomised controlled trial (the CRISP trial).

BACKGROUND: Coronary artery bypass grafting (CABG) is the treatment of choice for patients with multivessel coronary artery disease (CAD). Evidence from randomised controlled trials (RCTs) in low-risk populations shows that 'off-pump' CABG is at least as safe as 'on-pump' CABG, but high-quality trial data in high-risk populations are lacking. OBJECTIVES: To test the hypothesis that, in high-risk patients, off-pump coronary artery bypass grafting (OPCABG) reduces mortality and morbidity without causing a higher risk of reintervention compared with on-pump coronary artery bypass grafting (ONCABG). DESIGN: Open parallel-group RCT with a 1 : 1 allocation ratio and expertise-based randomisation. SETTING: Eight specialist cardiac surgery centres in the UK and one specialist centre in Kolkata, India. PARTICIPANTS: Patients with an additive European system for cardiac operative risk evaluation score (EuroSCORE) of ≥ 5, undergoing non-emergency isolated CABG via a median sternotomy. INTERVENTIONS: CABG without cardiopulmonary bypass (CPB), i.e. OPCABG on the beating heart, or CABG with CPB, i.e. ONCABG on a chemically arrested heart. MAIN OUTCOME MEASURES: Primary outcome - a composite of death or serious morbidity [all-cause mortality, myocardial infarction (MI), stroke, prolonged initial ventilation, sternal wound dehiscence] within 30 days of surgery. Secondary outcomes - quality of life (QoL) [Rose Angina Questionnaire, Canadian Cardiovascular Society (CCS) angina class, European QoL-5 Dimensions (EQ-5D), Coronary Revascularisation Outcome Questionnaire (CROQ)] and resource utilisation. RESULTS: The organisation of a tertiary cardiac surgery service in the UK presented several barriers to recruitment. Referral information was often inadequate to confirm eligibility. Limited surgeon participation at a centre, the need to meet referral-to-treatment performance targets and complex referral pathways did not support an expertise-based allocation. Urgent patients waiting for surgery in local 'feeder' hospitals were often not transferred until late the night before surgery, which limited the time available to take consent and organise the surgery on an expertise basis. Several elective patients declined to take part because they wanted the surgeon they had met when the surgery was first discussed in clinic to operate. Several initiatives were explored to boost recruitment. After 10 months of recruitment, the trial design was modified to permit both within-surgeon and expertise-based randomisation within a centre. However, this did not have sufficient impact and the trial was stopped on the grounds of futility after 106 patients (< 2% of the target sample size) had been recruited in 18 months. Ninety-eight patients were included in the trial analyses, six patients were withdrawn and two died before surgery. In both groups, 6% of patients experienced the primary outcome [adjusted odds ratio (OR) (OPCABG to ONCABG) 1.07; 95% confidence interval (CI) 0.27 to 4.14]. QoL scores at 4-8 weeks post surgery were similar in the two groups. Patients randomised to OPCABG had a shorter stay in the intensive care unit and in hospital after surgery (median 26.0 vs. 27.7 hours in intensive care and 7 vs. 8 days in hospital). CONCLUSIONS: The Coronary artery bypass grafting in high-RISk patients randomised to off- or on-Pump surgery (CRISP) trial was not successful for a range of logistical reasons. However, the experience gained is of value for the design and conduct of future trials. The surgical community have polarised views. A qualitative evaluation of the reasons behind the views held by the advocates of the two techniques is an area for future research. TRIAL REGISTRATION: Current Controlled Trials ISRCTN29161170. FUNDING: This project was funded by the Medical Research Council/National Institute for Health Research (NIHR) Efficacy and Mechanism Evaluation programme and will be published in full in Health Technology Assessment; Vol. 18, No. 44. See the NIHR Journals Library website for further project information.

Effect of intervention aimed at increasing physical activity, reducing sedentary behaviour, and increasing fruit and vegetable consumption in children: active for Life Year 5 (AFLY5) school based cluster randomised controlled trial.

OBJECTIVE: To investigate the effectiveness of a school based intervention to increase physical activity, reduce sedentary behaviour, and increase fruit and vegetable consumption in children. DESIGN: Cluster randomised controlled trial. SETTING: 60 primary schools in the south west of England. PARTICIPANTS: Primary school children who were in school year 4 (age 8-9 years) at recruitment and baseline assessment, in year 5 during the intervention, and at the end of year 5 (age 9-10) at follow-up assessment. INTERVENTION: The Active for Life Year 5 (AFLY5) intervention consisted of teacher training, provision of lesson and child-parent interactive homework plans, all materials required for lessons and homework, and written materials for school newsletters and parents. The intervention was delivered when children were in school year 5 (age 9-10 years). Schools allocated to control received standard teaching. MAIN OUTCOME MEASURES: The pre-specified primary outcomes were accelerometer assessed minutes of moderate to vigorous physical activity per day, accelerometer assessed minutes of sedentary behaviour per day, and reported daily consumption of servings of fruit and vegetables. RESULTS: 60 schools with more than 2221 children were recruited; valid data were available for fruit and vegetable consumption for 2121 children, for accelerometer assessed physical activity and sedentary behaviour for 1252 children, and for secondary outcomes for between 1825 and 2212 children for the main analyses. None of the three primary outcomes differed between children in schools allocated to the AFLY5 intervention and those allocated to the control group. The difference in means comparing the intervention group with the control group was -1.35 (95% confidence interval -5.29 to 2.59) minutes per day for moderate to vigorous physical activity, -0.11 (-9.71 to 9.49) minutes per day for sedentary behaviour, and 0.08 (-0.12 to 0.28) servings per day for fruit and vegetable consumption. The intervention was effective for three out of nine of the secondary outcomes after multiple testing was taken into account: self reported time spent in screen viewing at the weekend (-21 (-37 to -4) minutes per day), self reported servings of snacks per day (-0.22 (-0.38 to -0.05)), and servings of high energy drinks per day (-0.26 (-0.43 to -0.10)) were all reduced. Results from a series of sensitivity analyses testing different assumptions about missing data and from per protocol analyses produced similar results. CONCLUSION: The findings suggest that the AFLY5 school based intervention is not effective at increasing levels of physical activity, decreasing sedentary behaviour, and increasing fruit and vegetable consumption in primary school children. Change in these activities may require more intensive behavioural interventions with children or upstream interventions at the family and societal level, as well as at the school environment level. These findings have relevance for researchers, policy makers, public health practitioners, and doctors who are involved in health promotion, policy making, and commissioning services. Trial registration Current Controlled Trials ISRCTN50133740.

Characteristics associated with requested and required accelerometer wear in children.

OBJECTIVE: To investigate characteristics associated with wearing an accelerometer for the required and requested time among 8-year-old to 10-year-old children. DESIGN: Cross-sectional. SETTING: 60 Bristol and North Somerset primary schools taking part in the 'Active for Life Year 5' randomised controlled trial (RCT) in 2011. PARTICIPANTS: 2048 children, aged 8-10 years, invited to wear an accelerometer for 5 days of recording. PRIMARY OUTCOME MEASURE: Numbers meeting required wear-time for inclusion in main RCT analysis (≥8 h/day ≥3 days) and numbers meeting requested wear-time (≥8 h/day for all 5 days). RESULTS: 817 (40%) of the children wore the accelerometer for the requested time and 1629 (80%) for the required time. In adjusted multivariable analyses the odds of wearing the accelerometer for the required time were greater in females as compared with males (OR 1.76 (1.42-2.18)), those with higher scores for reporting their mother restricted time on sedentary behaviours (1.26 (1.04-1.52) per increase of 1 on a 1-4 scale) and in children from schools with larger year group sizes (1.01 (1.00-1.02) per additional child). Living in a neighbourhood with higher levels of deprivation (0.49 (0.33-0.72) comparing highest to lowest third of the deprivation score) or reporting higher levels of weekday outdoor play (0.97 (0.94, 1.00) per 30 min more) were associated with reduced odds of meeting required time. Results were essentially the same for requested wear-time. Other characteristics, including child body mass index, were not associated with required or requested wear-time. CONCLUSIONS: Only 40% of children wore the accelerometer for the requested time but 80% fulfilled the required criteria to be included in the main study analyses. Knowing which characteristics are associated with accelerometer wear could help target interventions to increase wear-time.