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Highlights90 documents were included: 79% (n=71) had data on definitions, 77% (n=69) on acceptability, 72% (n=65) on limitations and challenges, and 61% (n=55) on guidance for design/reporting of surrogate endpoints in trials.There was heterogeneity in how surrogate endpoints were defined.Key recommendation identified was the need to justify use of a surrogate endpoint using evidence of validation.Another key recommendation of this review was increased involvement of patients and public in trials that use surrogate endpoints.Synthesised items on the use of surrogate endpoints in trials from the review will inform the SPIRIT-SURROGATE and CONSORT-SURROGATE extensions.

Background: The purpose was to synthesize evidence on the association between nature-based Early Childhood Education (ECE) and children’s physical activity (PA) and motor competence (MC). Methods: A literature search of 9 databases was concluded in August 2020. Studies were eligible if (1) children were aged 2–7 years old and attending ECE, (2) ECE settings integrated nature, and (3) assessed physical outcomes. Two reviewers independently screened full-text articles and assessed study quality. Synthesis was conducted using effect direction (quantitative), thematic analysis (qualitative), and combined using a results-based convergent synthesis. Results: 1370 full-text articles were screened and 39 (31 quantitative and 8 qualitative) studies were eligible; 20 quantitative studies assessed PA and 6 assessed MC. Findings indicated inconsistent associations between nature-based ECE and increased moderate to vigorous PA, and improved speed/agility and object control skills. There were positive associations between nature-based ECE and reduced sedentary time and improved balance. From the qualitative analysis, nature-based ECE affords higher intensity PA and risky play, which could improve some MC domains. The quality of 28/31 studies was weak. Conclusions: More controlled experimental designs that describe the dose and quality of nature are needed to better inform the effectiveness of nature-based ECE on PA and MC.

Using a surrogate endpoint as a substitute for a primary patient relevant outcome enables randomised controlled trials (RCTs) assessing the efficacy/effectiveness of a variety of interventions to be conducted more efficiently, i.e., with shorter follow up, smaller sample size, and lower cost. However, there is currently no consensus-driven guideline for the reporting of RCTs using a surrogate endpoint as a primary outcome, therefore we seek to develop SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) and CONSORT (Consolidated Standards of Reporting Trials) extensions to improve the design and reporting of these trials. As an initial step, scoping and targeted reviews will identify potential items to be included in the extensions and trial and surrogate content authors to contribute to a Delphi consensus process.

In recent decades, the use of conditionality backed by benefit sanctions for those claiming unemployment and related benefits has become widespread in the social security systems of high-income countries. Critics argue that sanctions may be ineffective in bringing people back to employment or indeed harmful in a range of ways. Existing reviews largely assess the labour market impacts of sanctions but our understanding of the wider impacts is more limited. We report results from a scoping review of the international quantitative research evidence on both labour market and wider impacts of benefit sanctions. Following systematic search and screening, we extract data for 94 studies reporting on 253 outcome measures. We provide a narrative summary, paying attention to the ability of the studies to support causal inference. Despite variation in the evidence base and study designs, we found that labour market studies, covering two thirds of our sample, consistently reported positive impacts for employment but negative impacts for job quality and stability in the longer term, along with increased transitions to non-employment or economic inactivity. Although largely relying on non-experimental designs, wider-outcome studies reported significant associations with increased material hardship and health problems. There was also some evidence that sanctions were associated with increased child maltreatment and poorer child well-being. Lastly, the review highlights the generally poor quality of the evidence base in this area, with few studies employing research methods designed to identify the causal impact of sanctions, especially in relation to wider impacts.

Background:\ud Summer learning loss has been the subject of longstanding concern among researchers, the public and policy makers. The aim of the current research was to investigate inequality changes in children’s mental health and cognitive ability across the summer holidays.\ud \ud Methods:\ud We conducted linear and logistic regression analysis of mental health (borderline-abnormal total difficulty and prosocial scores on the strengths and difficulties questionnaire (SDQ)) and verbal cognitive ability (reading, verbal reasoning or vocabulary) at ages 7, 11 and 14, comparing UK Millennium Cohort Study members who were interviewed before and after the school summer holidays. Inequalities were assessed by including interaction terms in the outcome models between a discrete binary variable with values representing time periods and maternal academic qualifications. Coefficients of the interaction terms were interpreted as changes from the pre- to post-holiday period in the extent of inequality in the outcome between participants whose mothers had high or low educational qualifications. Separate models were fitted for each age group and outcome. We used inverse probability weights to allow for differences in the characteristics of cohort members assessed before and after the summer holidays.\ud \ud Results:\ud Mental health (borderline/abnormal SDQ total and prosocial scores) at ages 7 and 14 worsened and verbal cognitive ability scores at age 7 were lower among those surveyed after the summer holidays. Mental health inequalities were larger after the holidays at age 7 ([OR = 1.4; 95%CI (0.6, 3.2) and 14: [OR = 1.5; 95%CI (0.7, 3.2)], but changed little at age 11 (OR = 0.9; 95%CI (0.4, 2.6)]. There were differences in pro-social behaviours among those surveyed before/after the school holidays at age 14 [OR = 1.2; 95%CI (0.5, 3.5)] but not at age 7 or 11. There was little change in inequalities in verbal cognitive ability scores over the school holidays [Age 7: b = 1.3; 95%CI (− 3.3, 6.0); Age 11: b = − 0.7; 95%CI (− 4.3, 2.8); Age 14: b = − 0.3; 95%CI (− 1.0, 0.4)].\ud \ud Conclusion:\ud We found inequalities in mental health and cognitive ability according to maternal education, and some evidence or worsening mental health and mental health inequalities across school summer holidays. We found little evidence of widening inequalities in verbal cognitive ability. Widespread school closures during the COVID-19 restrictions have prompted concerns that prolonged closures may widen health and educational inequalities. Management of school closures should focus on preventing or mitigating inequalities that may arise from differences in the support for mental health and learning provided during closures by schools serving more or less disadvantaged children.

Additional file 1.

Background Behavioural weight management programmes are effective in assisting people with overweight or obesity to lose excess body weight. Yet, many still struggle to attain their weight loss goals in such programmes. Little is understood about the factors which impact success in these programmes. Synthesising this data will allow for theory to be developed on how to improve success in such programmes. The main aim of this review will be to extract and synthesise the barriers and facilitators of successful weight loss during participation of behavioural weight loss programmes in adults living with overweight and obesity. Methods A systematic search of MEDLINE, Embase, PsycINFO, The Cochrane Library and CINAHL will be performed from inception onwards. Studies will also be sought by contacting experts in the field, reference and website searching. Studies will be eligible if the participants are adults living with obesity (population) undertaking or recently completed behavioural weight loss programmes (intervention) with the primary focus of weight loss (outcome). The primary outcomes will be amount of weight lost and information on barriers and/or facilitators to success. The secondary outcomes will be reasons or factors related to attrition and adherence and behaviour change techniques used in programmes. Two reviewers will screen citations and full-text data. Reviewer 1 will screen all, and reviewer 2 will screen a random 50% of articles. Data extraction will be completed by reviewer 1, and 10% will be checked by the research team. Potential conflicts will be resolved through discussion. Data will be synthesised and described narratively to show the characteristics of each study, levels of success and barriers and facilitators during programme participation. A thematic approach will be taken, and themes will be coded against the levels of the socioecological model. Quantitative data will be extracted and categorised according to these themes and presented alongside the qualitative data. Discussion Our findings can be used to inform how weight loss programmes can be improved to facilitate success in those at risk of failure. Results will be published in a peer-reviewed journal. Systematic review registration (PROSPERO CRD42019148158 )

Additional file 1. PRISMA P checklist.

Additional file 2. Example search strategy for Medline.

Additional file 1. PRISMA Checklist.

Additional file 2. MEDLINE Search Strategy.

Additional file 3. Data extraction template – Quantitative and Qualitative

Additional file 4. Modified Effective Public Health Practice Project 444 (EPHPP) Quality Assessment Tool and Dixon-Woods (2004) Checklist.

PRISMA-P checklist. (DOCX 29 kb)

We have used mRNA differential display PCR to search for genes induced in activated T cells and have found the LGALS1 (lectin, galactoside-binding, soluble) gene to be strongly up-regulated in effector T cells. The protein coded by the LGALS1 gene is a beta-galactoside-binding protein (betaGBP), which is released by cells as a monomeric negative growth factor but which can also associate into homodimers (galectin-1) with lectin properties. Northern blot analysis revealed that ex vivo isolated CD8+ effector T cells induced by a viral infection expressed high amounts of LGALS1 mRNA, whereas LGALS1 expression was almost absent in resting CD8+ T cells. LGALS1 expression could be induced in CD4+ and CD8+ T cells upon activation with the cognate peptide antigen and high levels of LGALS1 expression were found in concanavalin A-activated T cells but not in lipopolysaccharide-activated B cells. Gel filtration and Western blot analysis revealed that only monomeric betaGBP was released by activated CD8+ T cells and in vitro experiments further showed that recombinant betaGBP was able to inhibit antigen-induced proliferation of naive and antigen-experienced CD8+ T cells. Thus, these data indicate a role of betaGBP as an autocrine negative growth factor for CD8+ T cells.

The purpose of this protocol is to describe the rationale, aims, research questions and planned methodology of the scoping review. Broadly in line with Tricco et al. (2018) we have developed a detailed plan of action with a view to follow a clear, consistent and transparent process. The scoping review is envisaged as an exploratory exercise aimed at identifying and mapping existing national and international quantitative evidence on the intended and unintended impacts of benefit sanctions for people on unemployment and related benefits. This review is intended to identify the nature of the evidence base and key characteristics of studies which investigate the impacts of benefit sanctions. Furthermore, this review aims to investigate features of the research designs and methodological approaches adopted by the selected studies.