Trial Forge Guidance 1 : what is a Study Within A Trial (SWAT)?

Randomised trials are a central component of all evidence-informed health care systems and the evidence coming from them helps to support health care users, health professionals and others to make more informed decisions about treatment. The evidence available to trialists to support decisions on design, conduct and reporting of randomised trials is, however, sparse. Trial Forge is an initiative that aims to increase the evidence base for trial decision-making and in doing so, to improve trial efficiency.One way to fill gaps in evidence is to run Studies Within A Trial, or SWATs. This guidance document provides a brief definition of SWATs, an explanation of why they are important and some practical 'top tips' that come from existing experience of doing SWATs. We hope the guidance will be useful to trialists, methodologists, funders, approvals agencies and others in making clear what a SWAT is, as well as what is involved in doing one

Equipoise across the patient population: Optimising recruitment to a randomised controlled trial

© 2016 The Author(s). Background: This paper proposes a novel perspective on the value of qualitative research for improving trial design and optimising recruitment. We report findings from a qualitative study set within the OPEN trial, a surgical randomised controlled trial (RCT) comparing two interventions for recurrent bulbar urethral stricture, a common cause of urinary problems in men. Methods: Interviews were conducted with men meeting trial eligibility criteria (n = 19) to explore reasons for accepting or declining participation and with operating urologists (n = 15) to explore trial acceptability. Results: Patients expressed various preferences and understood these in the context of relative severity and tolerability of their symptoms. Accounts suggest a common trajectory of worsening symptoms with a particular window within which either treatment arm would be considered acceptable. Interviews with clinician recruiters found that uncertainty varied between general and specialist sites, which reflect clinicians' relative exposure to different proportions of the patient population. Conclusion: Recruitment post referral, at specialist sites, was challenging due to patient (and clinician) expectations. Trial design, particularly where there are fixed points for recruitment along the care pathway, can enable or constrain the possibilities for effective accrual depending on how it aligns with the optimum point of patient equipoise. Qualitative recruitment investigations, often focussed on information provision and patient engagement, may also look to better understand the target patient population in order to optimise the point at which patients are approached. Trial registration: ISRCTN Registry, ISRCTN98009168. Registered on 29 November 2012

Foxp3 and Treg cells in HIV-1 infection and immuno-pathogenesis

FoxP3+CD4+CD25+ regulatory T (Treg) cells are implicated in a number of pathologic processes including elevated levels in cancers and infectious diseases, and reduced levels in autoimmune diseases. Treg cells are activated to modulate immune responses to avoid over-reactive immunity. However, conflicting findings are reported regarding relative levels of Treg cells during HIV-1 infection and disease progression. The role of Treg cells in HIV-1 diseases (aberrant immune activation) is poorly understood due to lack of a robust model. We summarize here the regulation and function of Foxp3 in Treg cells and in modulating HIV-1 replication. Based on recent findings from SIV/monkey and HIV/humanized mouse models, a model of the dual role of Treg cells in HIV-1 infection and immuno-pathogenesis is discussed

Improving Students’ Sexual History Inquiry and HIV Counseling with an Interactive Workshop Using Standardized Patients

Sexual history and HIV counseling are essential clinical skills. Our project's purpose was to evaluate a standardized patient (SP) educational intervention teaching third-year medical students sexual history taking and HIV counseling. A 4-hour SP workshop was delivered to one-half of the class. Four weeks later, all students engaged in an SP examination including one station on assessing sexual history taking and HIV counseling. Workshop participants scored one standard deviation higher on sexual history and HIV counseling items than nonparticipants. Our sexual history and HIV counseling curriculum was associated with students asking more thorough sexual histories and providing more HIV counseling

The impact of globalisation on qualitative research in comparative and international education

This is a revised version of the 2003 British Association for International and Comparative Education (BAICE) Presidential Address delivered at the 7th Oxford International Conference on Education and Development. The processes of globalisation have been viewed by some as a major threat to the qualitative research tradition in education. Two main aspects of the impact of globalisation on qualitative research are addressed here. Firstly, it is argued that given the vital role of culture in mediating global policies at different levels, qualitative research still has a very important role to play. Secondly, it is argued that the knowledge and information revolution associated with globalisation has created an increasingly positivist climate that represents both a challenge for, and a challenge to, comparative education as it is currently conceived—particularly in the UK. This is illustrated by the growing international interest in systematic review methodology and its associated privileging of quantitative research strategies, such as randomised controlled trials, in evidence-based policy