Nationally Automated Colonoscopy Performance Feedback Increases Polyp Detection: the NED APRIQOT Randomised Controlled Trial.

BACKGROUND AND AIMS: Post-colonoscopy colorectal cancer incidence and mortality rates are higher for endoscopists with low polyp detection rates. Using the UK's National Endoscopy Database (NED), which automatically captures real-time data, we assessed if providing feedback of case-mix-adjusted Mean Number of Polyps (aMNP), as a key performance indicator, improved endoscopists' performance. Feedback was delivered via a theory-informed evidence-based audit and feedback intervention. METHODS: This multicentre, prospective, NED Automated Performance Reports to Improve Quality Outcomes Trial (NED-APRIQOT) randomised NHS endoscopy centres to intervention or control. Intervention-arm endoscopists were emailed tailored monthly reports automatically generated within NED, informed by qualitative interviews and behaviour change theory. The primary outcome was endoscopists' aMNP during the 9-month intervention. RESULTS: From November 2020-July 2021, 541 endoscopists across 36 centres (19 intervention; 17 control) performed 54,770 procedures during the intervention, and 15,960 procedures during the 3-months post-intervention period. Comparing intervention-arm to control-arm endoscopists during the intervention period: aMNP was non-significantly higher (7%, 95% confidence interval (CI) -1% to 14%; p=0·08). Unadjusted MNP (10%, 95%CI 1-20%) and polyp detection rate (PDR) (10%, 95%CI 4-16%) were significantly higher. Differences were not maintained in the post-intervention period. In the intervention-arm, endoscopists accessing NED-APRIQOT webpages had higher aMNP than those who did not (118 vs 102 aMNP, p=0.03). CONCLUSION: Although our automated feedback intervention did not increase aMNP significantly in the intervention period; MNP and PDR did significantly improve. Engaged endoscopists benefited most and improvements were not maintained post-intervention; future work should address engagement in feedback and consider the effectiveness of continuous feedback. www.isrctn.org ISRCTN11126923.

The role of constraints and information gaps in driving risky medicine purchasing practices in four African countries.

Substandard and falsified (SF) medical products pose a major threat to public health and socioeconomic development, particularly in low- and middle-income countries. In response, public education campaigns have been developed to alert consumers about the risks of SF medicines and provide guidance on 'safer' practices, along with other demand- and supply-side measures. However, little is currently known about the potential effectiveness of such campaigns while structural constraints to accessing quality-assured medicines persist. This paper analyses survey data on medicine purchasing practices, information and constraints from four African countries (Ghana, Nigeria, Sierra Leone and Uganda; n > 1000 per country). Using multivariate regression and structural equation modelling, we present what we believe to be the first attempt to tease apart, statistically, the effects of an information gap vs structural constraints in driving potential public exposure to SF medicines. The analysis confirms that less privileged groups (including, variously, those in rural settlements, with low levels of formal education, not in paid employment, often women and households with a disability or long-term sickness) are disproportionately potentially exposed to SF medicines; these same demographic groups also tend to have lower levels of awareness and experience greater levels of constraint. Despite the constraints, our models suggest that public health education may have an important role to play in modifying some (but not all) risky practices. Appropriately targeted public messaging can thus be a useful part of the toolbox in the fight against SF medicines, but it can only work effectively in combination with wider-reaching reforms to address higher-level vulnerabilities in pharmaceutical supply chains in Africa and expand access to quality-assured public-sector health services.

Investigating health and social outcomes of the Big Local community empowerment initiative in England: a mixed method evaluation.

Background: Most research on community empowerment provides evidence on engaging communities for health promotion purposes rather than attempts to create empowering conditions. This study addresses this gap. Intervention: Big Local started in 2010 with £271M from the National Lottery. Ending in 2026, it gives 150 relatively disadvantaged communities in England control over £1M to improve their neighbourhoods. Objective: To investigate health and social outcomes, at the population level and among engaged residents, of the community engagement approach adopted in a place-based empowerment initiative. Study design, data sources and outcome variables: This study reports on the third wave of a longitudinal mixed-methods evaluation. Work package 1 used a difference-in-differences design to investigate the impact of Big Local on population outcomes in all 150 Big Local areas compared to matched comparator areas using secondary data. The primary outcome was anxiety; secondary outcomes included a population mental health measure and crime in the neighbourhood. Work package 2 assessed active engagement in Big Local using cross-sectional data and nested cohort data from a biannual survey of Big Local partnership members. The primary outcome was mental well-being and the secondary outcome was self-rated health. Work package 3 conducted qualitative research in 14 Big Local neighbourhoods and nationally to understand pathways to impact. Work package 4 undertook a cost-benefit analysis using the life satisfaction approach to value the benefits of Big Local, which used the work package 1 estimate of Big Local impact on life satisfaction. Results: At a population level, the impacts on 'reporting high anxiety' (-0.8 percentage points, 95% confidence interval -2.4 to 0.7) and secondary outcomes were not statistically significant, except burglary (-0.054 change in z-score, 95% confidence interval -0.100 to -0.009). There was some effect on reduced anxiety after 2017. Areas progressing fastest had a statistically significant reduction in population mental health measure (-0.053 change in z-score, 95% confidence interval -0.103 to -0.002). Mixed results were found among engaged residents, including a significant increase in mental well-being in Big Local residents in the nested cohort in 2018, but not by 2020; this is likely to be COVID-19. More highly educated residents, and males, were more likely to report a significant improvement in mental well-being. Qualitative accounts of positive impacts on mental well-being are often related to improved social connectivity and physical/material environments. Qualitative data revealed increasing capabilities for residents' collective control. Some negative impacts were reported, with local factors sometimes undermining residents' ability to exercise collective control. Finally, on the most conservative estimate, the cost-benefit calculations generate a net benefit estimate of £64M. Main limitations: COVID-19 impacted fieldwork and interpretation of survey data. There was a short 4-year follow-up (2016/20), no comparators in work package 2 and a lack of power to look at variations across areas. Conclusions: Our findings suggest the need for investment to support community organisations to emerge from and work with communities. Residents should lead the prioritisation of issues and design of solutions but not necessarily lead action; rather, agencies should work as equal partners with communities to deliver change. Funding: This project was funded by the National Institute for Health and Care Research (NIHR) Public Health Research Programme (16/09/13) and will be published in full in Public Health Research; Vol. 11, No. 9. See the NIHR Journals Library website for further project information.

The Communities in Control study is looking at the health impacts of the Big Local community empowerment programme, funded by the National Lottery Community Fund and managed by Local Trust (a national charitable organisation). Residents of 150 English areas have at least £1M and other support to improve the neighbourhoods. There have been three phases of the research. This report shares findings from their third phase, which began in 2018. First, we used data from a national survey and data from national health and welfare services to compare changes in mental health between people living in Big Local areas and those in similar areas that did not have a Big Local partnership. Furthermore, we also used publicly available data on crime in the neighbourhoods. We found weak evidence that Big Local was linked with improved mental health and a reduction in burglaries. Second, we used data from a survey conducted by Local Trust to look at health and social impacts on the most active residents. We found an increase in mental well-being in 2018 but this was not maintained in 2020, probably due to the COVID-19 pandemic. Third, we did interviews and observations in 14 Big Local areas to understand what helps and what does not help residents to improve their neighbourhoods. We found that partnerships need to have legitimacy, the right balance of support, and learning opportunities. Residents suggested that creating social connections and welcoming social spaces, improving how people view the area and tackling poverty contributed to health improvements. Direct involvement in Big Local was both stressful and rewarding. Finally, we did a cost­benefit analysis by putting a monetary value on residents' increase in life satisfaction due to Big Local and comparing it with the costs of Big Local. We found that the benefits exceed the costs by at least £60M, suggesting that Big Local provides good value for money.

Basket trials in oncology: a systematic review of practices and methods, comparative analysis of innovative methods, and an appraisal of a missed opportunity.

Background: Basket trials are increasingly used in oncology drug development for early signal detection, accelerated tumor-agnostic approvals, and prioritization of promising tumor types in selected patients with the same mutation or biomarker. Participants are grouped into so-called baskets according to tumor type, allowing investigators to identify tumors with promising responses to treatment for further study. However, it remains a question as to whether and how much the adoption of basket trial designs in oncology have translated into patient benefits, increased pace and scale of clinical development, and de-risking of downstream confirmatory trials. Methods: Innovation in basket trial design and analysis includes methods that borrow information across tumor types to increase the quality of statistical inference within each tumor type. We build on the existing systematic reviews of basket trials in oncology to discuss the current practices and landscape. We conceptually illustrate recent innovative methods for basket trials, with application to actual data from recently completed basket trials. We explore and discuss the extent to which innovative basket trials can be used to de-risk future trials through their ability to aid prioritization of promising tumor types for subsequent clinical development. Results: We found increasing adoption of basket trial design in oncology, but largely in the design of single-arm phase II trials with a very low adoption of innovative statistical methods. Furthermore, the current practice of basket trial design, which does not consider its impact on the clinical development plan, may lead to a missed opportunity in improving the probability of success of a future trial. Gating phase II with a phase Ib basket trial reduced the size of phase II trials, and losses in the probability of success as a result of not using innovative methods may not be recoverable by running a larger phase II trial. Conclusion: Innovative basket trial methods can reduce the size of early phase clinical trials, with sustained improvement in the probability of success of the clinical development plan. We need to do more as a community to improve the adoption of these methods.

Minithoracotomy vs Conventional Sternotomy for Mitral Valve Repair: A Randomized Clinical Trial.

Importance: The safety and effectiveness of mitral valve repair via thoracoscopically-guided minithoracotomy (minithoracotomy) compared with median sternotomy (sternotomy) in patients with degenerative mitral valve regurgitation is uncertain. Objective: To compare the safety and effectiveness of minithoracotomy vs sternotomy mitral valve repair in a randomized trial. Design, Setting, and Participants: A pragmatic, multicenter, superiority, randomized clinical trial in 10 tertiary care institutions in the UK. Participants were adults with degenerative mitral regurgitation undergoing mitral valve repair surgery. Interventions: Participants were randomized 1:1 with concealed allocation to receive either minithoracotomy or sternotomy mitral valve repair performed by an expert surgeon. Main Outcomes and Measures: The primary outcome was physical functioning and associated return to usual activities measured by change from baseline in the 36-Item Short Form Health Survey (SF-36) version 2 physical functioning scale 12 weeks after the index surgery, assessed by an independent researcher masked to the intervention. Secondary outcomes included recurrent mitral regurgitation grade, physical activity, and quality of life. The prespecified safety outcomes included death, repeat mitral valve surgery, or heart failure hospitalization up to 1 year. Results: Between November 2016 and January 2021, 330 participants were randomized (mean age, 67 years, 100 female [30%]); 166 were allocated to minithoracotomy and 164 allocated to sternotomy, of whom 309 underwent surgery and 294 reported the primary outcome. At 12 weeks, the mean between-group difference in the change in the SF-36 physical function T score was 0.68 (95% CI, -1.89 to 3.26). Valve repair rates (≈ 96%) were similar in both groups. Echocardiography demonstrated mitral regurgitation severity as none or mild for 92% of participants at 1 year with no difference between groups. The composite safety outcome occurred in 5.4% (9 of 166) of patients undergoing minithoracotomy and 6.1% (10 of 163) undergoing sternotomy at 1 year. Conclusions and relevance: Minithoracotomy is not superior to sternotomy in recovery of physical function at 12 weeks. Minithoracotomy achieves high rates and quality of valve repair and has similar safety outcomes at 1 year to sternotomy. The results provide evidence to inform shared decision-making and treatment guidelines. Trial Registration: isrctn.org Identifier: ISRCTN13930454.

Modeling the positive testing rate of COVID-19 in South Africa using a semi-parametric smoother for binomial data.

Identification and isolation of COVID-19 infected persons plays a significant role in the control of COVID-19 pandemic. A country's COVID-19 positive testing rate is useful in understanding and monitoring the disease transmission and spread for the planning of intervention policy. Using publicly available data collected between March 5th, 2020 and May 31st, 2021, we proposed to estimate both the positive testing rate and its daily rate of change in South Africa with a flexible semi-parametric smoothing model for discrete data. There was a gradual increase in the positive testing rate up to a first peak rate in July, 2020, then a decrease before another peak around mid-December 2020 to mid-January 2021. The proposed semi-parametric smoothing model provides a data driven estimates for both the positive testing rate and its change. We provide an online R dashboard that can be used to estimate the positive rate in any country of interest based on publicly available data. We believe this is a useful tool for both researchers and policymakers for planning intervention and understanding the COVID-19 spread.

Prehabilitation in elective patients undergoing cardiac surgery: a randomised control trial (THE PrEPS TRIAL) - a study protocol.

INTRODUCTION: Prehabilitation prior to surgery has been shown to reduce postoperative complications, reduce length of hospital stay and improve quality of life after cancer and limb reconstruction surgery. However, there are minimal data on the impact of prehabilitation in patients undergoing cardiac surgery, despite the fact these patients are generally older and have more comorbidities and frailty. This trial will assess the feasibility and impact of a prehabilitation intervention consisting of exercise and inspiratory muscle training on preoperative functional exercise capacity in adult patients awaiting elective cardiac surgery, and determine any impact on clinical outcomes after surgery. METHODS AND ANALYSIS: PrEPS is a randomised controlled single-centre trial recruiting 180 participants undergoing elective cardiac surgery. Participants will be randomised in a 1:1 ratio to standard presurgical care or standard care plus a prehabilitation intervention. The primary outcome will be change in functional exercise capacity measured as change in the 6 min walk test distance from baseline. Secondary outcomes will evaluate the impact of prehabilitation on preoperative and postoperative outcomes including; respiratory function, health-related quality of life, anxiety and depression, frailty, and postoperative complications and resource use. This trial will evaluate if a prehabilitation intervention can improve preoperative physical function, inspiratory muscle function, frailty and quality of life prior to surgery in elective patients awaiting cardiac surgery, and impact postoperative outcomes. ETHICS AND DISSEMINATION: A favourable opinion was given by the Sheffield Research Ethics Committee in 2019. Trial findings will be disseminated to patients, clinicians, commissioning groups and through peer-reviewed publication. TRIAL REGISTRATION NUMBER: ISRCTN13860094.

Preventing cardiotoxicity in patients with breast cancer and lymphoma: protocol for a multicentre randomised controlled trial (PROACT).

INTRODUCTION: Anthracyclines are included in chemotherapy regimens to treat several different types of cancer and are extremely effective. However, it is recognised that a significant side effect is cardiotoxicity; anthracyclines can cause irreversible damage to cardiac cells and ultimately impaired cardiac function and heart failure, which may only be evident years after exposure. The PROACT trial will establish the effectiveness of the ACE inhibitor enalapril maleate (enalapril) in preventing cardiotoxicity in patients with breast cancer and non-Hodgkin's lymphoma (NHL) receiving anthracycline-based chemotherapy. METHODS AND ANALYSIS: PROACT is a prospective, randomised, open-label, blinded end-point, superiority trial which will recruit adult patients being treated for breast cancer and NHL at NHS hospitals throughout England. The trial aims to recruit 106 participants, who will be randomised to standard care (high-dose anthracycline-based chemotherapy) plus enalapril (intervention) or standard care alone (control). Patients randomised to the intervention arm will receive enalapril (starting at 2.5 mg two times per day and titrating up to a maximum dose of 10 mg two times per day), commencing treatment at least 2 days prior to starting chemotherapy and finishing 3 weeks after their last anthracycline dose. The primary outcome is the presence or absence of cardiac troponin T release at any time during anthracycline treatment, and 1 month after the last dose of anthracycline. Secondary outcomes will focus on cardiac function measured using echocardiogram assessment, adherence to enalapril and side effects. ETHICS AND DISSEMINATION: A favourable opinion was given following research ethics committee review by West Midlands-Edgbaston REC, Ref: 17/WM/0248. Trial findings will be disseminated through engagement with patients, the oncology and cardiology communities, NHS management and commissioning groups and through peer-reviewed publication. TRIAL REGISTRATION NUMBER: NCT03265574.

Non-anemic iron deficiency predicts prolonged hospitalisation following surgical aortic valve replacement: a single-centre retrospective study.

BACKGROUND: Iron deficiency has deleterious effects in patients with cardiopulmonary disease, independent of anemia. Low ferritin has been associated with increased mortality in patients undergoing cardiac surgery, but modern indices of iron deficiency need to be explored in this population. METHODS: We conducted a retrospective single-centre observational study of 250 adults in a UK academic tertiary hospital undergoing median sternotomy for non-emergent isolated aortic valve replacement. We characterised preoperative iron status using measurement of both plasma ferritin and soluble transferrin receptor (sTfR), and examined associations with clinical outcomes. RESULTS: Measurement of plasma sTfR gave a prevalence of iron deficiency of 22%. Patients with non-anemic iron deficiency had clinically significant prolongation of total hospital stay (mean increase 2.2 days; 95% CI: 0.5-3.9; P = 0.011) and stay within the cardiac intensive care unit (mean increase 1.3 days; 95% CI: 0.1-2.5; P = 0.039). There were no deaths. Defining iron deficiency as a plasma ferritin < 100 µg/L identified 60% of patients as iron deficient and did not predict length of stay. No significant associations with transfusion requirements were evident using either definition of iron deficiency. CONCLUSIONS: These findings indicate that when defined using sTfR rather than ferritin, non-anemic iron deficiency predicts prolonged hospitalisation following surgical aortic valve replacement. Further studies are required to clarify the role of contemporary laboratory indices in the identification of preoperative iron deficiency in patients undergoing cardiac surgery. An interventional study of intravenous iron targeted at preoperative non-anemic iron deficiency is warranted.

Community health workers and health equity in low- and middle-income countries: systematic review and recommendations for policy and practice.

BACKGROUND: The deployment of Community Health Workers (CHWs) is widely promoted as a strategy for reducing health inequities in low- and middle-income countries (LMIC). Yet there is limited evidence on whether and how CHW programmes achieve this. This systematic review aimed to synthesise research findings on the following questions: (1) How effective are CHW interventions at reaching the most disadvantaged groups in LMIC contexts? and (2) What evidence exists on whether and how these programmes reduce health inequities in the populations they serve? METHODS: We searched six academic databases for recent (2014-2020) studies reporting on CHW programme access, utilisation, quality, and effects on health outcomes/behaviours in relation to potential stratifiers of health opportunities and outcomes (e.g., gender, socioeconomic status, place of residence). Quantitative data were extracted, tabulated, and subjected to meta-analysis where appropriate. Qualitative findings were synthesised using thematic analysis. RESULTS: One hundred sixty-seven studies met the search criteria, reporting on CHW interventions in 33 LMIC. Quantitative synthesis showed that CHW programmes successfully reach many (although not all) marginalized groups, but that health inequalities often persist in the populations they serve. Qualitative findings suggest that disadvantaged groups experienced barriers to taking up CHW health advice and referrals and point to a range of strategies for improving the reach and impact of CHW programmes in these groups. Ensuring fair working conditions for CHWs and expanding opportunities for advocacy were also revealed as being important for bridging health equity gaps. CONCLUSION: In order to optimise the equity impacts of CHW programmes, we need to move beyond seeing CHWs as a temporary sticking plaster, and instead build meaningful partnerships between CHWs, communities and policy-makers to confront and address the underlying structures of inequity. TRIAL REGISTRATION: PROSPERO registration number CRD42020177333 .

Early life, life course and gender influences on levels of C-reactive protein among migrant Bangladeshis in the UK.

BACKGROUND AND OBJECTIVES: Humans co-evolved with pathogens, especially helminths, that educate the immune system during development and lower inflammatory responses. The absence of such stimuli in industrialized countries is associated with higher baseline levels of C-reactive protein (CRP) among adults who appear at greater risk for inflammatory disorders. This cross-sectional study examined effects of early life development on salivary CRP levels in 452 British-Bangladeshis who spent varying periods growing up in Bangladesh or UK. We also analyzed how gender and central obesity modulate effects on CRP. We hypothesized that: (i) first-generation Bangladeshis with higher childhood exposure to pathogens would have chronically lower CRP levels than second-generation British-Bangladeshis; (ii) effects would be greater with early childhoods in Bangladesh; (iii) effects by gender would differ; and (iv) increasing obesity would mitigate early life effects. METHODOLOGY: Saliva samples were assayed for CRP using ELISAs, and anthropometric data collected. Participants completed questionnaires about demographic, socioeconomic, lifestyle and health histories. Data were analyzed using multiple linear regression. RESULTS: First-generation migrants who spent early childhoods in mostly rural, unhygienic areas, and moved to UK after age 8, had lower salivary CRP compared to the second-generation. Effects differed by gender, while waist circumference predicted higher CRP levels. CRP increased with years in UK, alongside growing obesity. CONCLUSIONS AND IMPLICATIONS: Our study supports the hypothesis that pathogen exposure in early life lowers inflammatory responses in adults. However, protective effects differed by gender and can be eroded by growing obesity across the life course which elevates risks for other inflammatory disorders. Lay Summary: Migrants to the UK who spent early childhoods in less hygienic environments in Bangladesh that help to educate their immune systems had lower levels of the inflammatory marker, C-reactive protein (CRP) compared to migrants who grew up in UK. Both gender and increasing obesity were associated with increased levels of CRP.

Formalising 'informal' mHealth in Ghana: Opportunities and challenges for Universal Health Coverage (UHC).

While mobile phones promise to be an important tool for bridging the healthcare gaps in resource-poor areas in developing countries, scalability and sustainability of mobile phones for health (mhealth) interventions still remain a major challenge. Meanwhile, health workers are already using their own mobile phones (referred to as 'informal mhealth') to facilitate healthcare delivery in diverse ways. Therefore, this paper explores some strategies for integrating 'informal mHealth' in the healthcare delivery of Ghana, by highlighting some opportunities and challenges. The study mainly employed a combination of literature review, focus group discussions and key informant interviews with community health nurses (CHNs) and other stakeholders, who were purposively selected from the three ecological zones in Ghana. The study found that, while scale-up of 'formal mhealth' remains challenging in Ghana, almost all CHNs in our study are using their personal mobile phones 'informally' to bridge healthcare gaps, thereby promoting universal health coverage. This provides opportunities for promoting (or formalising) 'informal' mhealth in Ghana, in spite of some practical challenges in the use of personal mobile phones that need to be addressed to ensure sustainable healthcare delivery in the country.

Local Inequalities in Health Behaviours: Longitudinal Findings from the Stockton-On-Tees Cohort Study.

This paper provides a longitudinal examination of local inequalities in health behaviours during a period of austerity, exploring the role of 'place' in explaining these inequalities. Data from the Stockton-on-Tees prospective cohort study of 836 individuals were analysed and followed over 18 months (37% follow-up). Generalised estimating equation models estimated the deprivation gap in health behaviours (smoking status, alcohol use, fruit and vegetable consumption and physical activity practices) between the 20% most- and least-deprived neighborhoods (LSOAs), explored any temporal changes during austerity, and examined the underpinning role of compositional and contextual determinants. All health behaviours, except for frequent physical activity, varied significantly by deprivation (p ≤ 0.001). Smoking was lower in the least-deprived areas (OR 0.21, CI 0.14 to 0.30), while alcohol use (OR 2.75, CI 1.98 to 3.82) and fruit and vegetable consumption (OR 2.55, CI 1.80 to 3.62) were higher in the least-deprived areas. The inequalities were relatively stable throughout the study period. Material factors (such as employment, education and housing tenure) were the most-important and environmental factors the least-important explanatory factors. This study suggests that material factors are the most important 'place' determinants of health behaviours. Health promotion activities should better reflect these drivers.

Mobile phone use and the welfare of community health nurses in Ghana: An analysis of unintended costs.

The use of mobile phones is fast transforming the healthcare delivery landscape in Ghana. A substantial number of health facilities are now dependent on mobile phones to facilitate their work. Evidence of the use of mobile phones in Ghana's healthcare is however limited. In order to contribute to the evidence of the value of using mobile phones to promote healthcare, we interrogated and highlighted unexpected costs imposed on community health nurses who use their personal mobile phones for healthcare delivery in the country. Data for the study were derived from 598 completed questionnaires and extracts from focus group discussions with community health nurses who were sampled from three regions across the three main ecological zones of Ghana. The results show that over 90% of nurses bear the cost of paying for airtime, bundles and chargers used for work-related activities, yet less than 10% of them receive direct compensation. This costly burden has the potential to demotivate the nurses and threaten the country's progress towards the achievement of universal health coverage. More significantly, the data strongly suggest that physical distance, regional location and gender are the main factors triggering extra costs incurred by the nurses. We conclude that the use of personal mobile phones for healthcare delivery imposed huge financial burden on community health workers in Ghana. A suggested intervention to forestall negative consequences on performance is to offer incentive packages to nurses as a compensation for the financial and non-physical costs of using personal mobile phones for work-related activities.

Impact of prehabilitation on objectively measured physical activity levels in elective surgery patients: a systematic review.

OBJECTIVE: To systematically review the impact of prehabilitation on objectively measured physical activity (PA) levels in elective surgery patients. DATA SOURCES: Articles published in Web of Science Core Collections, PubMed, Embase (Ovid), CINAHL (EBSCOHost), PsycInfo (EBSCOHost) and CENTRAL through August 2020. STUDY SELECTION: Studies that met the following criteria: (1) written in English, (2) quantitatively described the effect(s) of a PA intervention among elective surgery patients prior to surgery and (3) used and reported objective measures of PA in the study. DATA EXTRACTION AND SYNTHESIS: Participant characteristics, intervention details, PA measurement, and clinical and health-related outcomes were extracted. Risk of bias was assessed following the revised Cochrane risk of bias tool. Meta-analysis was not possible due to heterogeneity, therefore narrative synthesis was used. RESULTS: 6533 unique articles were identified in the search; 21 articles (based on 15 trials) were included in the review. There was little evidence to suggest that prehabilitation is associated with increases in objectively measured PA, but this may be due to insufficient statistical power as most (n=8) trials included in the review were small feasibility/pilot studies. Where studies tested associations between objectively measured PA during the intervention period and health-related outcomes, significant beneficial associations were reported. Limitations in the evidence base precluded any assessment via meta-regression of the association between objectively measured PA and clinical or health-related outcomes. CONCLUSIONS: Additional large-scale studies are needed, with clear and consistent reporting of objective measures including accelerometry variables and outcome variables, to improve our understanding of the impact of changes in PA prior to surgery on surgical and health-related outcomes. PROSPERO REGISTRATION NUMBER: CRD42019151475.

Fecal glucocorticoids and gastrointestinal parasite infections in wild western lowland gorillas (Gorilla gorilla gorilla) involved in ecotourism.

Wildlife ecotourism can offer a source of revenue which benefits local development and conservation simultaneously. However, habituation of wildlife for ecotourism can cause long-term elevation of glucocorticoid hormones, which may suppress immune function and increase an animal's vulnerability to disease. We have previously shown that western lowland gorillas (Gorilla gorilla gorilla) undergoing habituation in Dzanga-Sangha Protected Areas, Central African Republic, have higher fecal glucocorticoid metabolite (FGCM) levels than both habituated and unhabituated gorillas. Here, we tested the relationship between FGCM levels and strongylid infections in the same gorillas. If high FGCM levels suppress the immune system, we predicted that FGCM levels will be positively associated with strongylid egg counts and that gorillas undergoing habituation will have the highest strongylid egg counts, relative to both habituated and unhabituated gorillas. We collected fecal samples over 12 months in two habituated gorilla groups, one group undergoing habituation and completely unhabituated gorillas. We established FGCM levels and fecal egg counts of Necator/Oesophagostomum spp. and Mammomonogamus sp. Controlling for seasonal variation and age-sex category in strongylid infections we found no significant relationship between FGCMs and Nectator/Oesophagostomum spp. or Mammomonogamus sp. egg counts in a within group comparison in either a habituated group or a group undergoing habituation. However, across groups, egg counts of Nectator/Oesophagostomum spp. were lowest in unhabituated animals and highest in the group undergoing habituation, matching the differences in FGCM levels among these gorilla groups. Our findings partially support the hypothesis that elevated glucocorticoids reduce a host's ability to control the extent of parasitic infections, and show the importance of non-invasive monitoring of endocrine function and parasite infection in individuals exposed to human pressure including habituation process and ecotourism.

A clinical and cost-effectiveness trial of a parent group intervention to manage challenging restricted and repetitive behaviours in young children with autism spectrum disorder: study protocol for a randomised controlled trial.

BACKGROUND: Restricted and repetitive behaviours vary greatly across the autism spectrum, and although not all are problematic some can cause distress and interfere with learning and social opportunities. We have, alongside parents, developed a parent group based intervention for families of young children with autism, which aims to offer support to parents and carers; helping them to recognise, understand and learn how to respond to their child's challenging restricted repetitive behaviours. METHODS: The study is a clinical and cost-effectiveness, multi-site randomised controlled trial of the Managing Repetitive Behaviours (MRB) parent group intervention versus a psychoeducation parent group Learning About Autism (LAA) (n = 250; 125 intervention/125 psychoeducation; ~ 83/site) for parents of young children aged 3-9 years 11 months with a diagnosis of autism. All analyses will be done under intention-to-treat principle. The primary outcome at 24 weeks will use generalised estimating equation (GEE) to compare proportion of children with improved RRB between the MRB group and the LAA group. The GEE model will account for the clustering of children by parent groups using exchangeable working correlation. All secondary outcomes will be analysed in a similar way using appropriate distribution and link function. The economic evaluation will be conducted from the perspective of both NHS costs and family access to local community services. A 'within trial' cost-effectiveness analysis with results reported as the incremental cost per additional child achieving at least the target improvement in CGI-I scale at 24 weeks. DISCUSSION: This is an efficacy trial to investigate the clinical and cost-effectiveness of a parent group based intervention designed to help parents understand and manage their child's challenging RRB. If found to be effective, this intervention has the potential to improve the well-being of children and their families, reduce parental stress, greatly enhance community participation and potential for learning, and improve longer-term outcomes. TRIAL REGISTRATION: Trial ID: ISRCTN15550611 Date registered: 07/08/2018. Sponsor and Monitor: Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust R&D Manager Lyndsey Dixon, Address: St Nicholas Hospital, Jubliee Road, Gosforth, Newcastle upon Tyne NE3 3XT, lyndsey.dixon@cntw.nhs.uk , Tel: 0191 246 7222.

Informal mhealth at scale in Africa: Opportunities and challenges.

The extraordinary global growth of digital connectivity has generated optimism that mobile technologies can help overcome infrastructural barriers to development, with 'mobile health' (mhealth) being a key component of this. However, while 'formal' (top-down) mhealth programmes continue to face challenges of scalability and sustainability, we know relatively little about how health-workers are using their own mobile phones informally in their work. Using data from Ghana, Ethiopia and Malawi, we document the reach, nature and perceived impacts of community health-workers' (CHWs') 'informal mhealth' practices, and ask how equitably these are distributed. We implemented a mixed-methods study, combining surveys of CHWs across the three countries, using multi-stage proportional-to-size sampling (N = 2197 total), with qualitative research (interviews and focus groups with CHWs, clients and higher-level stake-holders). Survey data were weighted to produce nationally- or regionally-representative samples for multivariate analysis; comparative thematic analysis was used for qualitative data. Our findings confirm the limited reach of 'formal' compared with 'informal' mhealth: while only 15% of CHWs surveyed were using formal mhealth applications, over 97% reported regularly using a personal mobile phone for work-related purposes in a range of innovative ways. CHWs and clients expressed unequivocally enthusiastic views about the perceived impacts of this 'informal health' usage. However, they also identified very real practical challenges, financial burdens and other threats to personal wellbeing; these appear to be borne disproportionately by the lowest-paid cadre of health-workers, especially those serving rural areas. Unlike previous small-scale, qualitative studies, our work has shown that informal mhealth is already happening at scale, far outstripping its formal equivalent. Policy-makers need to engage seriously with this emergent health system, and to work closely with those on the ground to address sources of inequity, without undermining existing good practice.

Minimally invasive versus conventional sternotomy for Mitral valve repair: protocol for a multicentre randomised controlled trial (UK Mini Mitral).

INTRODUCTION: Numbers of patients undergoing mitral valve repair (MVr) surgery for severe mitral regurgitation have grown and will continue to rise. MVr is routinely performed via median sternotomy; however, there is a move towards less invasive surgical approaches.There is debate within the clinical and National Health Service (NHS) commissioning community about widespread adoption of minimally invasive MVr surgery in the absence of robust research evidence; implementation requires investment in staff and infrastructure.The UK Mini Mitral trial will provide definitive evidence comparing patient, NHS and clinical outcomes in adult patients undergoing MVr surgery. It will establish the best surgical approach for MVr, setting a standard against which emerging percutaneous techniques can be measured. Findings will inform optimisation of cost-effective practice. METHODS AND ANALYSIS: UK Mini Mitral is a multicentre, expertise based randomised controlled trial of minimally invasive thoracoscopically guided right minithoracotomy versus conventional sternotomy for MVr. The trial is taking place in NHS cardiothoracic centres in the UK with established minimally invasive mitral valve surgery programmes. In each centre, consenting and eligible patients are randomised to receive surgery performed by consultant surgeons who meet protocol-defined surgical expertise criteria. Patients are followed for 1 year, and consent to longer term follow-up.Primary outcome is physical functioning 12 weeks following surgery, measured by change in Short Form Health Survey (SF-36v2) physical functioning scale. Early and 1 year echo data will be reported by a core laboratory. Estimates of key clinical and health economic outcomes will be reported up to 5 years.The primary economic outcome is cost effectiveness, measured as incremental cost per quality-adjusted life year gained over 52 weeks following index surgery. ETHICS AND DISSEMINATION: A favourable opinion was given by Wales REC 6 (16/WA/0156). Trial findings will be disseminated to patients, clinicians, commissioning groups and through peer reviewed publication. TRIAL REGISTRATION NUMBER: ISRCTN13930454.

Inequalities and Inclusion in Exercise Referral Schemes: A Mixed-Method Multi-Scheme Analysis.

Physical activity prescription, commonly through exercise referral schemes, is an established disease prevention and management pathway. There is considerable heterogeneity in terms of uptake, adherence, and outcomes, but because within-scheme analyses dominate previous research, there is limited contextual understanding of this variance. Both the impact of schemes on health inequalities and best practices for inclusion of at-risk groups are unclear. To address this, we modelled secondary data from the multi-scheme National Referral Database, comprising 23,782 individuals across 14 referral schemes, using a multilevel Bayesian inference approach. Scheme-level local demographics identified over-sampling in uptake; on the basis of uptake and completion data, more inclusive schemes (n = 4) were identified. Scheme coordinators were interviewed, and data were analyzed using a grounded theory approach. Inequalities presented in a nuanced way. Schemes showed promise for engaging populations at greater risk of poor health (e.g., those from more deprived areas or of an ethnic minority background). However, the completion odds were lower for those with a range of complex circumstances (e.g., a mental health-related referral). We identified creative best practices for widening access (e.g., partnership building), maintaining engagement (e.g., workforce diversity), and tailoring support, but recommend changes to wider operational contexts to ensure such approaches are viable.