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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.

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.

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)