Effects of weight loss interventions for adults who are obese on mortality, cardiovascular disease and cancer : a systematic review and meta-analysis

We thank Associate Professor Andrew Grey for helping to resolve discrepancies in data extraction and interpretation for cardiovascular events and cancer events. We thank trialists from 16 studies for clarifying or providing additional information for this review [Andrews 2011, Aveyard 2016, Bennett 2012, de Vos 2014, Finnish Diabetes Prevention Study 2009, Goodwin 2014, Green 2015, Horie 2016, Hunt (FFIT) 2014, Katula 2013, Li (Da Qing) 2014, Logue 2005, Ma 2013, O’Neil 2016, Rejeski (CLIP) 2011, Uusitupa 1993] and also others who provided information, but their trials were later found not to fulfil our inclusion criteria. Funding: The Health Services Research Unit is funded by the Chief Scientist Office of the Scottish Government Health and Social Care Directorate.Peer reviewedPublisher PD

Systematic review of perioperative and quality-of-life outcomes following surgical management of localised renal cancer

UCAN Cancer Charity (www.ucanhelp.org.uk) and MacMillan Cancer Charity (www.macmillan.org.uk) helped design and conduct the study.Peer reviewedPostprin

A core outcome set for localised prostate cancer effectiveness trials : protocol for a systematic review of the literature and stakeholder involvement through interviews and a Delphi survey

Acknowledgements We would like to thank Professor Craig Ramsay, Professor Luke Vale, and Professor Vikki Entwistle for their comments on earlier drafts of the protocol. This study is funded by the Cancer Research Aberdeen and North East Scotland (CRANES) charity. Paula Williamson would like to acknowledge funding from the European Union Seventh Framework Programme (FP7/2007-2013, FP7/2007-2011) under grant agreement number 305081 for the COMET initiative, which provided support for this work.Peer reviewedPublisher PD

Breast pumps as an incentive for breastfeeding: a mixed methods study of acceptability

Increasing breastfeeding rates would improve maternal and child health, but multiple barriers to breastfeeding persist. Breast pump provision has been used as an incentive for breastfeeding, although effectiveness is unclear. Women's use of breast pumps is increasing and a high proportion of mothers express breastmilk. No research has yet reported women's and health professionals' perspectives on breast pumps as an incentive for breastfeeding. In the Benefits of Incentives for Breastfeeding and Smoking cessation in pregnancy (BIBS) study, mixed methods research explored women's and professionals' views of breast pumps as an incentive for breastfeeding. A survey of health professionals across Scotland and North West England measured agreement with ‘a breast pump costing around£40 provided for free on the NHS’ as an incentive strategy. Qualitative interviews and focus groups were conducted in two UK regions with a total of 68 participants (pregnant women, new mothers, and their significant others and health professionals) and thematic analysis undertaken. The survey of 497 health professionals found net agreement of 67.8% (337/497) with the breast pump incentive strategy, with no predictors of agreement shown by a multiple ordered logistic regression model. Qualitative research found interrelated themes of the ‘appeal and value of breast pumps’, ‘sharing the load’, ‘perceived benefits’, ‘perceived risks’ and issues related to ‘timing’. Qualitative participants expressed mixed views on the acceptability of breast pumps as an incentive for breastfeeding. Understanding the mechanisms of action for pump type, timing and additional support required for effectiveness is required to underpin trials of breast pump provision as an incentive for improving breastfeeding outcomes

Mortality and quality of life in the five years after severe sepsis

Peer reviewedPublisher PD

The effectiveness and cost-effectiveness of resuscitative endovascular balloon occlusion of the aorta (REBOA) for trauma patients with uncontrolled torso haemorrhage : study protocol for a randomised clinical trial (the UK-REBOA trial)

Acknowledgements The UK-REBOA trial grantholders include Jan O. Jansen, University of Aberdeen, UK, and University of Alabama at Birmingham, USA; Marion K. Campbell, University of Aberdeen, UK; Chris Moran, Nottingham University Hospital Trust, UK; Karim Brohi, Queen Mary University of London, UK; Fiona Lecky, University of Sheffield, UK; Robbie Lendrum, Bart’s Health NHS Trust, UK; Graeme MacLennan, University of Aberdeen, UK; Jonathan J. Morrison, University of Maryland, USA; Nigel Tai, Academic Department of Military Surgery and Trauma, Royal Centre for Defence Medicine, UK; Tim Harris, Bart’s Health NHS Trust, UK; John Norrie, University of Edinburgh, UK; Dwayne Boyers, University of Aberdeen, UK; Alan Paterson, University of Strathclyde, UK; and Nick Welch. Funding {4} This study/project is funded by the National Institute for Health Research (NIHR) HTA Programme (reference 14/199/09). The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care. The funder has/had no role in the design of the study; the collection, analysis, and interpretation of data; or writing the manuscript. The Health Services Research Unit, Institute of Applied Health Sciences (University of Aberdeen), is core-funded by the Chief Scientist Office of the Scottish Government Health and Social Care Directorates.Peer reviewedPublisher PD

The ethics of future trials: qualitative analysis of physicians' decision making

Background: The decision to conduct a randomized controlled trial (RCT) in a field raises ethical as well as scientific issues. From the clinical equipoise literature, future trials are justifiable if there is ”honest, professional disagreement in the community of expert practitioners as to the preferred treatment”. Empirical data are sparse about how clinicians apply the principles of equipoise to the justification of future RCTs. For example, selective decontamination of the digestive tract (SDD) is not widely used in critical care practice despite the strength of the evidence base and therefore provides a unique opportunity to learn how clinicians think about the ethics of further RCTs in critical care. Methods: In an international interview study of views of healthcare professionals about SDD, we undertook a secondary analysis of qualitative data collected using a Theoretical Domains Framework of clinical behaviour. We adopted a general descriptive approach to explore how physicians determined whether another RCT of SDD is ethical. Following a constant comparison approach, three investigators reviewed 54 purposively chosen transcripts from three international regions. We interpreted the data using thematic analysis. Results: We grouped participants’ responses into four inter-related themes: 1) cultural norms about evidence and practice within healthcare; 2) personal views about what evidence is current or applicable; 3) the interpersonal and relational nature of professional decision making locally; and 4) an a priori commitment to future trials. The analysis also identified several unresolved tensions regarding when a future RCT should be pursued. These tensions focused on a clash between potential benefits to current individual patients and potential future harms to patients more broadly. Conclusions: Our study suggests that ethical decision making about future RCTs in the field of SDD does not rely strongly on appeals to evidence, even when the quality of the evidence is reasonably high. Rather, “extra-evidential” reasons, including social, professional, and relational factors, seem to influence opinions regarding the ethics of future trials. Further work is required to see if these conclusions are applicable to other clinical topics and settings

Surveillance mammography for detecting ipsilateral breast tumour recurrence and metachronous contralateral breast cancer: a systematic review

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Benefits of Incentives for Breastfeeding and Smoking cessation in pregnancy (BIBS): a mixed-methods study to inform trial design

Background: Smoking in pregnancy and/or not breastfeeding have considerable negative health outcomes for mother and baby. Aim: To understand incentive mechanisms of action for smoking cessation in pregnancy and breastfeeding, develop a taxonomy and identify promising, acceptable and feasible interventions to inform trial design. Design: Evidence syntheses, primary qualitative survey, and discrete choice experiment (DCE) research using multidisciplinary, mixed methods. Two mother-and-baby groups in disadvantaged areas collaborated throughout. Setting: UK. Participants: The qualitative study included 88 pregnant women/recent mothers/partners, 53 service providers, 24 experts/decision-makers and 63 conference attendees. The surveys included 1144 members of the general public and 497 health professionals. The DCE study included 320 women with a history of smoking. Methods: (1) Evidence syntheses: incentive effectiveness (including meta-analysis and effect size estimates), delivery processes, barriers to and facilitators of smoking cessation in pregnancy and/or breastfeeding, scoping review of incentives for lifestyle behaviours; (2) qualitative research: grounded theory to understand incentive mechanisms of action and a framework approach for trial design; (3) survey: multivariable ordered logit models; (4) DCE: conditional logit regression and the log-likelihood ratio test. Results: Out of 1469 smoking cessation and 5408 breastfeeding multicomponent studies identified, 23 smoking cessation and 19 breastfeeding studies were included in the review. Vouchers contingent on biochemically proven smoking cessation in pregnancy were effective, with a relative risk of 2.58 (95% confidence interval 1.63 to 4.07) compared with non-contingent incentives for participation (four studies, 344 participants). Effects continued until 3 months post partum. Inconclusive effects were found for breastfeeding incentives compared with no/smaller incentives (13 studies) but provider commitment contracts for breastfeeding show promise. Intervention intensity is a possible confounder. The acceptability of seven promising incentives was mixed. Women (for vouchers) and those with a lower level of education (except for breastfeeding incentives) were more likely to disagree. Those aged ≤ 44 years and ethnic minority groups were more likely to agree. Agreement was greatest for a free breast pump and least for vouchers for breastfeeding. Universal incentives were preferred to those targeting low-income women. Initial daily text/telephone support, a quitting pal, vouchers for > £20.00 per month and values up to £80.00 increase the likelihood of smoking cessation. Doctors disagreed with provider incentives. A ‘ladder’ logic model emerged through data synthesis and had face validity with service users. It combined an incentive typology and behaviour change taxonomy. Autonomy and well-being matter. Personal difficulties, emotions, socialising and attitudes of others are challenges to climbing a metaphorical ‘ladder’ towards smoking cessation and breastfeeding. Incentive interventions provide opportunity ‘rungs’ to help, including regular skilled flexible support, a pal, setting goals, monitoring and outcome verification. Individually tailored and non-judgemental continuity of care can bolster women’s capabilities to succeed. Rigid, prescriptive interventions placing the onus on women to behave ‘healthily’ risk them feeling pressurised and failing. To avoid ‘losing face’, women may disengage. Limitations: Included studies were heterogeneous and of variable quality, limiting the assessment of incentive effectiveness. No cost-effectiveness data were reported. In surveys, selection bias and confounding are possible. The validity and utility of the ladder logic model requires evaluation with more diverse samples of the target population. Conclusions: Incentives provided with other tailored components show promise but reach is a concern. Formal evaluation is recommended. Collaborative service-user involvement is importan

Project Soothe: A pilot study evaluating the mood effects of soothing images collected using a citizen science approach

Background: Mentally-generated soothing imagery is a therapeutic technique to support mental wellbeing, but some individuals may require support using externally presented stimuli. Project Soothe was launched to collect soothing images using a citizen science approach. This online pilot study evaluated the first 575 soothing images collected, examining: 1) if the images were perceived to be soothing; 2) if viewing the images had a positive impact on mood; and 3) if mood effects were influenced by individual differences in age, gender and depressive symptoms. Methods: We recruited 1152 participants (13 – 79 years, M = 35.62, SD = 14.60; 77% female). Participants were randomly allocated to one of 23 sets, each containing 25 images (n = 50 per set) and asked to rate their emotional response (soothed, excited, and anxious) to each image. Participants also reported their mood states pre- and post-viewing the images (using the International Positive and Negative Affect Schedule – Short Form). Results: Project Soothe images were rated to be significantly more soothing than anxiety- or excitement-inducing. Further, viewing 25 images was significantly associated with an increase in positive affect and decrease in negative affect. These effects were associated with age and depressive symptoms, with older individuals and those with lower depressive symptoms being associated with more positive changes in mood. Conclusions: This pilot study provides preliminary evidence that these soothing images can promote positive mood changes. Further work can now replicate these findings in larger-scale studies with comparison groups and extended outcome variables. The images and associated data have been made available in a data repository (OSF) as a free resource for researchers and practitioners. It is hoped that these images can be developed into useful therapeutic resources