-
Article
Open AccessUsing healthcare systems data for outcomes in clinical trials: issues to consider at the design stage
Healthcare system data (HSD) are increasingly used in clinical trials, augmenting or replacing traditional methods of collecting outcome data. This study, PRIMORANT, set out to identify, in the UK context, iss...
-
Article
Open AccessFurther considerations for placebo controls in surgical trials
The use of invasive placebo controls in surgical trials can be challenging. The ASPIRE guidance, published in the Lancet in 2020, provided advice for the design and conduct of surgical trials with an invasive ...
-
Article
Open AccessThe effectiveness and cost-effectiveness of resuscitative endovascular balloon occlusion of the aorta (REBOA) for trauma patients with uncontrolled torso haemorrhage: study protocol for a randomised clinical trial (the UK-REBOA trial)
Haemorrhage is the most common cause of preventable death after injury. REBOA is a novel technique whereby a percutaneously inserted balloon is deployed in the aorta, providing a relatively quick means of temp...
-
Article
Open AccessBehavioural optimisation to address trial conduct challenges: case study in the UK-REBOA trial
Clinical trials comprise multiple processes at various stages of the trial lifecycle. These processes often involve complex behaviours such as recruiting vulnerable patient populations and clinicians having to...
-
Article
Open AccessHow can behavioural science help us design better trials?
-
Article
Open AccessProviding trial results to participants in phase III pragmatic effectiveness RCTs: a sco** review
There is an ethical imperative to offer the results of trials to those who participated. Existing research highlights that less than a third of trials do so, despite the desire of participants to receive the r...
-
Article
Open AccessDevelopment of a behaviour change workplace-based intervention to improve nurses’ eating and physical activity
There is a critical need for an intervention to improve nurses’ eating and physical activity behaviours. As nurses spend a substantial proportion of their waking hours at work, concerted efforts to deliver suc...
-
Article
Open AccessDevelopment and evaluation of decision aids for people considering taking part in a clinical trial: a conceptual framework
Ethical requirements of informed consent stipulate that patients approached to participate in a clinical trial be provided with written information that must cover key aspects of the trial. For consent to be d...
-
Article
Open AccessStakeholder views regarding ethical issues in the design and conduct of pragmatic trials: study protocol
Randomized controlled trial (RCT) trial designs exist on an explanatory-pragmatic spectrum, depending on the degree to which a study aims to address a question of efficacy or effectiveness. As conceptualized b...
-
Article
Open AccessProtocol for the development of a CONSORT extension for RCTs using cohorts and routinely collected health data
Randomized 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 gener...
-
Article
Open AccessDevelo** a framework for the ethical design and conduct of pragmatic trials in healthcare: a mixed methods research protocol
There is a widely recognized need for more pragmatic trials that evaluate interventions in real-world settings to inform decision-making by patients, providers, and health system leaders. Increasing availabili...
-
Article
Open AccessSurgeons’ and methodologists’ perceptions of utilising an expertise-based randomised controlled trial design: a qualitative study
Randomised controlled trials (RCTs) are widely recognised to be the most rigorous way to test new and emerging clinical interventions. When the interventions under study are two different surgical procedures, ...
-
Article
Open AccessUnderstanding perceived determinants of nurses’ eating and physical activity behaviour: a theory-informed qualitative interview study
Unhealthy eating and physical activity behaviours are common among nurses but little is known about determinants of eating and physical activity behaviour in this population. The present study used a theoretic...
-
Article
Open AccessSubversion of allocation concealment in a randomised controlled trial: a historical case study
If the randomisation process within a trial is subverted, this can lead to selection bias that may invalidate the trial’s result. To avoid this problem, it is recommended that some form of concealment should b...
-
Article
Open AccessExploring the role and function of trial steering committees: results of an expert panel meeting
The independent oversight of clinical trials, which is recommended by the Medical Research Council (MRC) Guidelines for Good Clinical Practice, is typically provided by an independent advisory Data Monitoring ...
-
Article
Open AccessEvaluation of interventions for informed consent for randomised controlled trials (ELICIT): protocol for a systematic review of the literature and identification of a core outcome set using a Delphi survey
The process of obtaining informed consent for participation in randomised controlled trials (RCTs) was established as a mechanism to protect participants against undue harm from research and allow people to re...
-
Article
Open AccessA core outcome set for localised prostate cancer effectiveness trials: protocol for a systematic review of the literature and stakeholder involvement through interviews and a Delphi survey
Prostate cancer is a growing health problem worldwide. The management of localised prostate cancer is controversial. It is unclear which of several surgical, radiotherapeutic, ablative, and surveillance treatm...
-
Article
Open AccessPerceived difficulty and appropriateness of decision making by General Practitioners: a systematic review of scenario studies
Health-care quality in primary care depends largely on the appropriateness of General Practitioners’ (GPs; Primary Care or Family Physicians) decisions, which may be influenced by how difficult they perceive d...
-
Article
Open AccessEffects of workplace-based dietary and/or physical activity interventions for weight management targeting healthcare professionals: a systematic review of randomised controlled trials
The prevalence of overweight and obesity is high amongst healthcare professionals and there is growing interest in delivering weight loss interventions in the workplace. We conducted a systematic review to (i)...
-
Article
Open AccessStrengthening the ethical assessment of placebo-controlled surgical trials: three proposals
Placebo-controlled surgical trials can provide important information about the efficacy of surgical interventions. However, they are ethically contentious as placebo surgery entails the risk of harms to recipi...
