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IntroductionLarge-for-gestational age (LGA) fetuses have an increased risk of shoulder dystocia. This can lead to adverse neonatal outcomes and death. Early induction of labour in women with a fetus suspected to be macrosomic may mitigate the risk of shoulder dystocia. The Big Baby Trial aims to find if induction of labour at 38+0–38+4weeks’ gestation, in pregnancies with suspected LGA fetuses, reduces the incidence of shoulder dystocia.Methods and analysisThe Big Baby Trial is a multicentre, prospective, individually randomised controlled trial of induction of labour at 38+0to 38+4weeks’ gestation vs standard care as per each hospital trust (median gestation of delivery 39+4) among women whose fetuses have an estimated fetal weight >90th customised centile according to ultrasound scan at 35+0to 38+0weeks’ gestation. There is a parallel cohort study for women who decline randomisation because they opt for induction, expectant management or caesarean section. Up to 4000 women will be recruited and randomised to induction of labour or to standard care. The primary outcome is the incidence of shoulder dystocia; assessed by an independent expert group, blind to treatment allocation, from delivery records. Secondary outcomes include birth trauma, fractures, haemorrhage, caesarean section rate and length of inpatient stay. The main trial is ongoing, following an internal pilot study. A qualitative reporting, health economic evaluation and parallel process evaluation are included.Ethics and disseminationThe study received a favourable opinion from the South West—Cornwall and Plymouth Health Research Authority on 23/03/2018 (IRAS project ID 229163). Study results will be reported in the National Institute for Health Research journal library and published in an open access peer-reviewed journal. We will plan dissemination events for key stakeholders.Trial registration numberISRCTN18229892.

Background Assessing the long term effects of many surgical interventions tested in pragmatic RCTs may require extended periods of participant follow-up to assess effectiveness and use patient-reported outcomes that require large sample sizes. Consequently the RCTs are often perceived as being expensive and time-consuming, particularly if the results show the test intervention is not effective. Adaptive, and particularly group sequential, designs have great potential to improve the efficiency and cost of testing new and existing surgical interventions. As a means to assess the potential utility of group sequential designs, we re-analyse data from a number of recent high-profile RCTs and assess whether using such a design would have caused the trial to stop early. Methods Many pragmatic RCTs monitor participants at a number of occasions (e.g. at 6, 12 and 24 months after surgery) during follow-up as a means to assess recovery and also to keep participants engaged with the trial process. Conventionally one of the outcomes is selected as the primary (final) outcome, for clinical reasons, with others designated as either early or late outcomes. In such settings, novel group sequential designs that use data from not only the final outcome but also from early outcomes at interim analyses can be used to inform stopping decisions. We describe data from seven recent surgical RCTs (WAT, DRAFFT, WOLLF, FASHION, CSAW, FIXDT, TOPKAT), and outline possible group sequential designs that could plausibly have been proposed at the design stage. We then simulate how these group sequential designs could have proceeded, by using the observed data and dates to replicate how information could have accumulated and decisions been made for each RCT. Results The results of the simulated group sequential designs showed that for two of the RCTs it was highly likely that they would have stopped for futility at interim analyses, potentially saving considerable time (15 and 23 months) and costs and avoiding patients being exposed to interventions that were either ineffective or no better than standard care. We discuss the characteristics of RCTs that are important in order to use the methodology we describe, particularly the value of early outcomes and the window of opportunity when early stopping decisions can be made and how it is related to the length of recruitment period and follow-up. Conclusions The results for five of the RCTs tested showed that group sequential designs using early outcome data would have been feasible and likely to provide designs that were at least as efficient, and possibly more efficient, than the original fixed sample size designs. In general, the amount of information provided by the early outcomes was surprisingly large, due to the strength of correlations with the primary outcome. This suggests that the methods described here are likely to provide benefits more generally across the range of surgical trials and more widely in other application areas where trial designs, outcomes and follow-up patterns are structured and behave similarly.

The standard gear for the International Bottom Trawl Survey (IBTS), a fisheries-independent research survey originating from the 1960s, will be replaced. The long-term monitoring pro-vides data on commercial pelagic and demersal fish species for stock assessments and facili-tates examination of changes in fish distribution and abundance. The remit of this Workshop on the Further Development of the New IBTS Gear (WKFDNG) was to design a simple gear, as standardised as possible, robust, and easy to maintain. Additionally, the workshop was tasked to provide input for the roadmap towards implementation of the new gear.

OBJECTIVE: Typically, migraine prevention trials focus on reducing migraine days. This narrow focus may not capture all that is important to people with migraine. Inconsistency in outcome selection across trials limits the potential for data pooling and evidence synthesis. In response, we describe the development of core outcome set for migraine (COSMIG). DESIGN: A two-stage approach sought to achieve international, multistakeholder consensus on both the core domain set and core measurement set. Following construction of a comprehensive list of outcomes, expert panellists (patients, healthcare professionals and researchers) completed a three-round electronic-Delphi study to support a reduction and prioritisation of core domains and outcomes. Participants in a consensus meeting finalised the core domains and methods of assessment. All stages were overseen by an international core team, including patient research partners. RESULTS: There was a good representation of patients (episodic migraine (n=34) and chronic migraine (n=42)) and healthcare professionals (n=33) with high response and retention rates. The initial list of domains and outcomes was reduced from >50 to 7 core domains for consideration in the consensus meeting, during which a 2-domain core outcome set was agreed. CONCLUSION: International and multistakeholder consensus emerged to describe a two-domain core outcome set for reporting research on preventive interventions for chronic and episodic migraine: migraine-specific pain and migraine-specific quality of life. Intensity of migraine pain assessed with an 11-point Numerical Rating Scale and the frequency as the number of headache/migraine days over a specified time period. Migraine-specific quality of life assessed using the Migraine Functional Impact Questionnaire.

Environmental factors which influence reading performance of disabled readers are explored. The author first surveyed related literature and selected the following significant environmental factors: self-esteem, parental attitudes and behavior, and overt classroom behavior of children, ages 7 to 12. The Parent Attitude Research Instrument, Parent Interview Form, Self-Esteem Inventory, Soares and Soares Self-Concept Instruments, and Children's Behavior Questionnaire were then selected to measure each of these factors. The instruments were assessed, and it was found that they could be used within a reading improvement program to add to a diagnostic battery of tests to give evidence on environmental factors in influencing reading. The last part of the report deals with how these instruments could be used in a reading improvement program and how the use would change the present masters of science program in education-reading at Whitewater State University. A bibliography and appendixes of test forms are included. (AW)

The International Bottom Trawl Survey Working Group (IBTSWG) coordinates fishery-inde-pendent multispecies bottom-trawl surveys within the ICES area. These long-term monitoring surveys provide data for stock assessments and facilitate examination of changes in fish distri-bution and abundance. The group also promotes the standardization of fishing gears and meth-ods and survey coordination. This report summarizes the national contributions in 2020–2021 and plans for the 2021–2022 surveys coordinated by IBTSWG. In the North Sea, the surveys are performed in quarters (Q) Q1 and Q3 while in the Northeast Atlantic the surveys are conducted in Q1, Q3, and Q4 with a suite of 14 national surveys covering a large area of continental shelf that ranges from North of Scotland to the Gulf of Cádiz. Despite the COVID-measures and bad weather, most surveys were able to complete the majority of the planned hauls. The Portuguese survey (PT-GFS-Q4) was cancelled in 2020 due to issues associated with the new vessel and a COVID-outbreak. A COVID-related delay in submitting the cruise application form for the French CGFS20 survey resulted in no authorisation to trawl in UK waters and only 70% of the core stations were completed. Issues with the UK permits, were also experienced in the North Sea surveys, only being resolved at the last moment, expected to be a returning issue. Therefore, IBTSWG addressed the permit issue in further detail in order to better evaluate the impact and propose possible solutions. All surveys, except for the Spanish GCGF-Q1 21 which is cancelled due to a vessel refit, are planned to take place according to the manuals in the next year. The SCOROC Q3 20 survey recorded second highest recruitment of zero group haddock on the Rockall Bank since the start of the new survey series in 2011. The North Sea Q1 21 survey rec-orded good recruitment of haddock as well, and high recruitment of mackerel, while overall herring recruitment seemed low except for three exceptionally large catches in the Skager-rak/Kattegat bringing the index above average. Both North Sea surveys reported large amounts of target species outside their index areas, which may warrant a revision of the species-specific areas on which the standard abundance indices are calculated. IBTSWG will continue a number of collaborative activities later this year. The Workshop on the Further Development of the New IBTS Gear (WKFDN) will focus on updating results of gear trails with the potential new gears. The Workshop on the production of swept area estimates for all hauls in DATRAS for biodiversity assessments (WKSAE) will continue work on the North-eastern Atlantic Flexfile available via DATRAS, for which country specific algorithms are used to fill data gaps relevant for the calculation of the swept area. This and the already available North Sea Flexfile can be used to produces swept area indices. IBTSWG also met with members of the assessment groups, Working Group on the Assessment of Demersal Stocks in the North Sea and Skagerrak (WGNSSK) and Working Group on Elasmobranch Fishes (WGEF), to improve communication on for example circumstances affecting the execution of the surveys but also changes in survey design potentially impacting the indices.

This guide to terminology has been created to support staff and students in understanding helpful and appropriate ways to refer to people who have previously been convicted of a criminal offence. It has been put together with input from a survey of NTU Psychology staff, best practice guidance from the American Psychological Association, The Marshall (Language) Project, Her Majesty’s Prison and Probation Service, academic journals, research, and individuals with a vested interest in the use of language that supports rather than excludes.

Study designIndividual participant data (IPD) meta-analysis.ObjectiveThe aim of this study was to identify which participant characteristics moderate the effect of spinal manipulative therapy (SMT) on pain and functioning in chronic LBP.Summary of backgroundThe effects of SMT are comparable to other interventions recommended in guidelines for chronic low back pain (LBP); however, it is unclear which patients are more likely to benefit from SMT compared to other therapies.MethodsIPD were requested from randomized controlled trials (RCTs) examining the effect of SMT in adults with chronic LBP for pain and function compared to various other therapies (stratified by comparison). Potential patient moderators (n = 23) were a priori based on their clinical relevance. We investigated each moderator using a one-stage approach with IPD and investigated this interaction with the intervention for each time point (1, 3, 6, and 12 months).ResultsWe received IPD from 21 of 46 RCTs (n = 4223). The majority (12 RCTs, n = 2249) compared SMT to recommended interventions. The duration of LBP, baseline pain (confirmatory), smoking, and previous exposure to SMT (exploratory) had a small moderating effect across outcomes and follow-up points; these estimates did not represent minimally relevant differences in effects; for example, patients with ConclusionWe did not identify any moderators that enable clinicians to identify which patients are likely to benefit more from SMT compared to other treatments.Level of Evidence: 2.

Background Proven treatments for low back pain, at best, only provide modest overall benefits. Matching people to treatments that are likely to be most effective for them may improve clinical outcomes and makes better use of health care resources. Methods We conducted an individual participant data meta-analysis of randomised controlled trials of three types of therapist delivered interventions for low back pain (active physical, passive physical and psychological treatments). We applied two statistical methods (recursive partitioning and adaptive risk group refinement) to identify potential subgroups who might gain greater benefits from different treatments from our individual participant data meta-analysis. Results We pooled data from 19 randomised controlled trials, totalling 9328 participants. There were 5349 (57%) females with similar ratios of females in control and intervention arms. The average age was 49 years (standard deviation, SD, 14). Participants with greater psychological distress and physical disability gained most benefit in improving on the mental component scale (MCS) of SF-12/36 from passive physical treatment than non-active usual care (treatment effects, 4.3; 95% confidence interval, CI, 3.39 to 5.15). Recursive partitioning method found that participants with worse disability at baseline gained most benefit in improving the disability (Roland Morris Disability Questionnaire) outcome from psychological treatment than non-active usual care (treatment effects, 1.7; 95% CI, 1.1 to 2.31). Adaptive risk group refinement did not find any subgroup that would gain much treatment effect between psychological and non-active usual care. Neither statistical method identified any subgroups who would gain an additional benefit from active physical treatment compared to non-active usual care. Conclusions Our methodological approaches worked well and may have applicability in other clinical areas. Passive physical treatments were most likely to help people who were younger with higher levels of disability and low levels of psychological distress. Psychological treatments were more likely to help those with severe disability. Despite this, the clinical importance of identifying these subgroups is limited. The sizes of sub-groups more likely to benefit and the additional effect sizes observed are small. Our analyses provide no evidence to support the use of sub-grouping for people with low back pain.

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