This paper argues for more randomised controlled trials in educational research. Educational researchers have largely abandoned the methodology they helped to pioneer. This gold-standard methodology should be more widely used as it is an appropriate and robust research technique. Without subjecting curriculum innovations to a RCT then potentially harmful educational initiatives could be visited upon the nation's children.

In response to concern over the numeracy skills deficit displayed by student nurses, an online computer programme, ?Authentic World??, which aims to simulate a real-life clinical environment and improve the medication dosage calculation skills of users, was developed (Founded in 2004 Authentic World Ltd is a spin out company of Glarmorgan and Cardiff Universities, Cardiff, Wales UK.). Two randomised controlled trials were conducted, each at a UK University, in order to investigate the impact of Authentic World? on student nurses? general (...) numeracy abilities. All first year nursing students who gave consent were randomised equally into an intervention or control group. The intervention group were given access to Authentic World?. The primary outcome measure was the students? scores on a general numeracy test. The Intention to Treat (ITT) analysis in both trials revealed a small negative effect of Authentic World? on general numeracy, which was statistically significant in one trial. However, compliance with the intervention was very low in both trials, with only 24 and 12% of students allocated to the intervention groups spending more than 15 minutes using the programme. Providing nursing students with access to Authentic World? is not an effective use of resources since use of the programme appears to be very low. (shrink)

BackgroundRandomized controlled trials (RCTs) are often complex and expensive to perform. Less than one third achieve planned recruitment targets, follow-up can be labor-intensive, and many have limited real-world generalizability. Designs for RCTs conducted using cohorts and routinely collected health data, including registries, electronic health records, and administrative databases, have been proposed to address these challenges and are being rapidly adopted. These designs, however, are relatively recent innovations, and published RCT reports often do not describe important aspects of their methodology in (...) a standardized way. Our objective is to extend the Consolidated Standards of Reporting Trials (CONSORT) statement with a consensus-driven reporting guideline for RCTs using cohorts and routinely collected health data.MethodsThe development of this CONSORT extension will consist of five phases. Phase 1 (completed) consisted of the project launch, including fundraising, the establishment of a research team, and development of a conceptual framework. In phase 2, a systematic review will be performed to identify publications (1) that describe methods or reporting considerations for RCTs conducted using cohorts and routinely collected health data or (2) that are protocols or report results from such RCTs. An initial “long list” of possible modifications to CONSORT checklist items and possible new items for the reporting guideline will be generated based on the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) and The REporting of studies Conducted using Observational Routinely-collected health Data (RECORD) statements. Additional possible modifications and new items will be identified based on the results of the systematic review. Phase 3 will consist of a three-round Delphi exercise with methods and content experts to evaluate the “long list” and generate a “short list” of key items. In phase 4, these items will serve as the basis for an in-person consensus meeting to finalize a core set of items to be included in the reporting guideline and checklist. Phase 5 will involve drafting the checklist and elaboration-explanation documents, and dissemination and implementation of the guideline.DiscussionDevelopment of this CONSORT extension will contribute to more transparent reporting of RCTs conducted using cohorts and routinely collected health data. (shrink)

Randomised controlled trials (RCTs) are often seen as the 'gold standard' of evaluative research. However, whilst randomisation will ensure comparable groups, trials are still vulnerable to a range of biases that can undermine their internal validity. In this paper we describe a number of common threats to the internal validity of RCTs and methods of countering them. We highlight a number of examples from randomised trials in education and health care where problems of execution and analysis of the RCT has (...) undermined their internal validity. However, awareness of these potential biases can lead to careful planning to avoid or reduce their occurrence. If good quality randomised trials are to inform policy and practice in education then rigorous trials need to be designed that are the least susceptible to threats to their validity. (shrink)

Randomized controlled trials in educational research tend to be small. Small trials can have large, chance, imbalances in important covariates. For studies with sample sizes greater than 50, chance imbalances can be corrected using analysis of covariance; for small trials, however, statistical power is maximized if the trial is balanced and analysis of covariance is used in the analysis. The aim of the present study was to discuss methods of improving covariate balance in trial design and to demonstrate the method (...) of minimization. Using an exemplar of a cluster or class‐randomized trial with 29 classes, we employed minimization to achieve covariate balance. Minimization achieved good balance on four prognostic variables. Many trialists in education use restricted forms of allocation, including pairing or stratified randomization. These approaches have disadvantages. Another approach rarely used in educational research is minimization. Minimization uses a simple arithmetic algorithm to produce balanced groups across a number of important covariates and should be more widely used in educational and psychological research. (shrink)