Pragmatic cluster randomised controlled trial of contextualised grammar teaching and small group teaching to improve the writing skills of 11 year old children

Introduction: We evaluated two interventions: a contextualised grammar teaching intervention – Grammar for Writing - to assess whether it improved 11 year old children’s writing skills; and a small group literacy intervention to assess whether or not this was effective. Design and method: We used a pragmatic cluster randomised trial with partial split plot design. Independent concealed randomisation was undertaken at the class level, and, within the intervention group, children were also individually randomised to receive the whole class intervention plus a small group intervention or to receive the intervention in a whole class setting only. The main outcomes were writing and reading assessed by the Progress in English 11 (Long Form) test (GL Assessment). Results: In 2013, 55 schools in England, each with two classes, were recruited and randomised. Within each school, the two classes were randomly allocated to receive either the intervention or the control condition. After randomisation, 2 schools withdrew, leaving 53 schools, 106 classes and 2510 pupils. We observed an effect size (ES) of 0.10 favouring the Grammar for Writing classes; however, this was not statistically significant (95% confidence interval (CI) -0.10 to 0.31). Pupils randomised to the small groups had an increased literacy score when compared with the control classes (ES = 0.24, 95% CI 0.00 to 0.49) and when compared with the intervention children taught in the whole class (ES = 0.21, 95% CI 0.04 to 0.38). Conclusion: There is little evidence that this form of contextualised grammar teaching had an effect on 11 year old children’s writing skills. There was some evidence of an effect for small group teaching

Support and follow-up needs of patients discharged from intensive care after severe COVID-19: a mixed-methods study of the views of UK general practitioners and intensive care staff during the pandemic’s first wave

Objectives To identify follow-up services planned for patients with COVID-19 discharged from intensive care unit (ICU) and to explore the views of ICU staff and general practitioners (GPs) regarding these patients’ future needs and care coordination.Design This is a sequential mixed-methods study using online surveys and semistructured interviews. Interview data were inductively coded and thematically analysed. Survey data were descriptively analysed.Setting GP surgeries and acute National Health Service Trusts in the UK.Participants GPs and clinicians leading care for patients discharged from ICU.Primary and secondary outcomes Usual follow-up practice after ICU discharge, changes in follow-up during the pandemic, and GP awareness of follow-up and support needs of patients discharged from ICU.Results We obtained 170 survey responses and conducted 23 interviews. Over 60% of GPs were unaware of the follow-up services generally provided by their local hospitals and whether or not these were functioning during the pandemic. Eighty per cent of ICUs reported some form of follow-up services, with 25% of these suspending provision during the peak of the pandemic and over half modifying their provision (usually to provide the service remotely). Common themes relating to barriers to provision of follow-up were funding complexities, remit and expertise, and communication between ICU and community services. Discharge documentation was described as poor and lacking key information. Both groups mentioned difficulties accessing services in the community and lack of clarity about who was responsible for referrals and follow-up.Conclusions The pandemic has highlighted long-standing issues of continuity of care and complex funding streams for post-ICU follow-up care. The large cohort of ICU patients admitted due to COVID-19 highlights the need for improved follow-up services and communication between specialists and GPs, not only for patients with COVID-19, but for all those discharged from ICU

No difference found in time to publication by statistical significance of trial results: a methodological review

Objective: Time-lag from study completion to publication is a potential source of publication bias in randomised controlled trials. This study sought to update the evidence base by identifying the effect of the statistical significance of research findings on time to publication of trial results.Design: Literature searches were carried out in four general medical journals from June 2013 to June 2014 inclusive (BMJ, JAMA, the Lancet and the New England Journal of Medicine). Setting: Methodological review of four general medical journals. Participants: Original research articles presenting the primary analyses from phase 2, 3 and 4 parallel-group randomised controlled trials were included. Main outcome measures: Time from trial completion to publication.Results: The median time from trial completion to publication was 431 days (n ¼ 208, interquartile range 278–618). A multivariable adjusted Cox model found no statistically significant difference in time to publication for trials reporting positive or negative results (hazard ratio: 0.86, 95% CI 0.64 to 1.16, p ¼ 0.32). Conclusion: In contrast to previous studies, this review did not demonstrate the presence of time-lag bias in time to publication. This may be a result of these articles being published in four high-impact general medical journals that may be more inclined to publish rapidly, whatever the findings. Further research is needed to explore the presence of time-lag bias in lower quality studies and lower impact journals

Remote or on-site visits were feasible for the initial setup meetings with hospitals in a multicenter surgical trial : an embedded randomized trial

Objectives To investigate the effects, costs and feasibility of providing on-site compared with remote meetings to set-up hospital sites in a multi-centre, surgical randomised controlled trial. Study Design and Setting Hospitals were randomised to receive the initial trial set-up meetings on-site (i.e. face-toface) or remotely (i.e. via teleconference). Data were collected on site set-up, recruitment, follow-up and costs for the two methods. The hospital staff experience of trial set-up was also surveyed. Results Thirty-nine sites were randomised and 33 sites set-up to recruit (19 on-site and 14 remote). For sites randomised to an on-site meeting compared with remote meeting respectively, the time from first contact to first recruit was a median of 246 days [interquartile range (IQR) 196 to 346] vs 212 days [IQR 154 to 266], mean recruitment was 10 participants [median 10, IQR 2 to 17] vs 11 participants [median 6, IQR 5 to 23] and participant follow-up at 12 months was 81% vs 82%. Sites allocated to an initial on-site visit cost on average 289.83 more to set-up. Conclusion Remote or on-site visits are feasible for the initial set-up meetings with hospitals in a multicentre surgical trial. This embedded trial should be replicated to improve generalisability and increase statistical power using meta-analysis. ISRCTN78899574. Keywords: Study Within a Trial; Randomised Controlled Trial; Recruitment; Response rate; Costs; Feasibility A running title: Remote and on-site visits were feasible for the initial set-up meetings with hospitals in a multi-centre surgical tria

A randomized, embedded trial of pre-notification of trial participation did not increase recruitment rates to a falls prevention trial

Objectives: To design and evaluate the effectiveness of a pre-notification leaflet about research to increase recruitment to a randomised controlled trial (RCT). Methods: A methodological, two arm, randomised controlled trial was conducted, embedded within an existing cohort RCT (REFORM). Participants were randomised for the embedded trial, using a 1:2 (intervention:control) allocation ratio, prior to being randomised for the REFORM RCT. Controls received a trial recruitment pack. The intervention group received an additional pre-notification leaflet 2 to 3 weeks before the recruitment pack. Primary and secondary analyses were conducted using relative risk, the Cox Proportional Hazards Model and Incremental Cost Effectiveness Ratios. Results: Of the 1,436 intervention group participants, 73 (5.1%) were randomised into the REFORM trial compared to 126 (4.4%) of the 2,878 control group participants. The associated relative risk (1.16) was not statistically significant (95% CI 0.88 - 1.56). The leaflet did not significantly increase return rate (RR 1.10, 95% CI 0.92 -1.28) or decrease time to return (Hazard Ratio: 1.11, 95% CI 0.93 -1.33). Incremental Cost Effectiveness Ratios indicated that the intervention may be cost-effective if the true estimate of effect were close to the upper bound of the associated 95% CI. Conclusion: A pre-notification leaflet to potential trial participants demonstrated a small difference in favour of the intervention with regards randomisation (0.7% difference) and return rates (1.1% difference).Results should however be interpreted with caution as confidence intervals for these estimates cross the point of no effect. Nevertheless, this research enhances existing evidence for pre-notification to increase recruitment rates, with further development and assessment of this potentially cost-effective intervention being recommended