Health technology assessment : HTA
-
Health Technol Assess · Jul 2014
Death, bereavement and randomised controlled trials (BRACELET): a methodological study of policy and practice in neonatal and paediatric intensive care trials.
Researchers have seldom included bereaved parents in studies of participants' views of randomised controlled trials (RCTs); hence our understanding of the impact of trials is based on skewed and incomplete samples. Little is known about parental experiences of the death of a child subsequent to their enrolment in a trial or of provision made for this experience by clinicians and trial teams. The Bereavement and RAndomised ControlLEd Trials (BRACELET) study was funded to consider bereavement in the context of paediatric intensive care (PIC) and neonatal intensive care (NIC) trials. ⋯ Funding for this study was provided by the Health Technology Assessment programme of the National Institute for Health Research.
-
Health Technol Assess · Jul 2014
The opportunities and challenges of pragmatic point-of-care randomised trials using routinely collected electronic records: evaluations of two exemplar trials.
Pragmatic trials compare the effects of different decisions in usual clinical practice. ⋯ EHR point-of-care trials are feasible, although the recruitment of clinicians is a major challenge owing to the complexity of trial approvals. These trials will provide substantial evidence on clinical effectiveness only if trial interventions and participating clinicians and patients are typical of usual clinical care and trials are simple to initiate and conduct. Recommendations for research include the development of evidence and implementation of risk proportionality in trial governance and conduct.
-
Health Technol Assess · Jul 2014
Randomized Controlled Trial Multicenter Study Comparative StudyCoronary artery bypass grafting in high-RISk patients randomised to off- or on-Pump surgery: a randomised controlled trial (the CRISP trial).
Coronary artery bypass grafting (CABG) is the treatment of choice for patients with multivessel coronary artery disease (CAD). Evidence from randomised controlled trials (RCTs) in low-risk populations shows that 'off-pump' CABG is at least as safe as 'on-pump' CABG, but high-quality trial data in high-risk populations are lacking. ⋯ The Coronary artery bypass grafting in high-RISk patients randomised to off- or on-Pump surgery (CRISP) trial was not successful for a range of logistical reasons. However, the experience gained is of value for the design and conduct of future trials. The surgical community have polarised views. A qualitative evaluation of the reasons behind the views held by the advocates of the two techniques is an area for future research.
-
Health Technol Assess · Jul 2014
ReviewVitamin D supplementation in pregnancy: a systematic review.
It is unclear whether or not the current evidence base allows definite conclusions to be made regarding the optimal maternal circulating concentration of 25-hydroxyvitamin D [25(OH)D] during pregnancy, and how this might best be achieved. ⋯ The National Institute for Health Research Health Technology Assessment programme.
-
Health Technol Assess · Jul 2014
Randomized Controlled Trial Multicenter StudyFolate Augmentation of Treatment--Evaluation for Depression (FolATED): randomised trial and economic evaluation.
Folate deficiency is associated with depression. Despite the biological plausibility of a causal link, the evidence that adding folate enhances antidepressant treatment is weak. ⋯ The FolATED trial generated no evidence that folic acid was clinically effective or cost-effective in augmenting ADM. This negative finding is consistent with improving understanding of the one-carbon folate pathway suggesting that methylfolate is a better candidate for augmenting ADM. Hence the findings of FolATED undermine treatment guidelines that advocate folic acid for treating depression, and suggest future trials of methylfolate to augment ADM.