Health technology assessment : HTA
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Health Technol Assess · Oct 2019
Randomized Controlled Trial Clinical TrialGroup cognitive-behavioural programme to reduce the impact of rheumatoid arthritis fatigue: the RAFT RCT with economic and qualitative evaluations.
Fatigue is a major problem in rheumatoid arthritis (RA). There is evidence for the clinical effectiveness of cognitive-behavioural therapy (CBT) delivered by clinical psychologists, but few rheumatology units have psychologists. ⋯ Given the paucity of RA fatigue interventions, rheumatology teams might investigate the pragmatic implementation of the RAFT programme, which is low cost.
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Health Technol Assess · Oct 2019
Randomized Controlled Trial Multicenter Study Clinical TrialIntravenous co-amoxiclav to prevent infection after operative vaginal delivery: the ANODE RCT.
Sepsis is a leading cause of direct and indirect maternal death in both the UK and globally. All forms of operative delivery are associated with an increased risk of sepsis, and the National Institute for Health and Care Excellence's guidance recommends the use of prophylactic antibiotics at all caesarean deliveries, based on substantial randomised controlled trial evidence of clinical effectiveness. A Cochrane review, updated in 2017 (Liabsuetrakul T, Choobun T, Peeyananjarassri K, Islam QM. Antibiotic prophylaxis for operative vaginal delivery. Cochrane Database Syst Rev 2017;8:CD004455), identified only one small previous trial of prophylactic antibiotics following operative vaginal birth (forceps or ventouse/vacuum extraction) and, given the small study size and extreme result, suggested that further robust evidence is needed. ⋯ This trial has shown clear evidence of benefit of a single intravenous dose of prophylactic co-amoxiclav after operative vaginal birth. These results may lead to reconsideration of official policy/guidance. Further analysis of the mechanism of action of this single dose of antibiotic is needed to investigate whether earlier, pre-delivery or repeated administration could be more effective. Until these analyses are completed, there is no indication for administration of more than a single dose of prophylactic antibiotic, or for pre-delivery administration.
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Health Technol Assess · Oct 2019
A support package for parents of excessively crying infants: development and feasibility study.
Around 20% of 1- to 4-month-old infants cry for long periods without an apparent reason. Traditionally, this was attributed to gastrointestinal disorder ('colic'), but evidence shows that just 5% of infants cry a lot because of organic disturbances; in most cases, the crying is attributable to normal developmental processes. This has led to a focus on the impact of the crying on parents. Parental vulnerabilities influence how parents evaluate and respond to the crying and predict adverse outcomes. By developing evidence-based services that support parents, this study was designed to take the first steps towards national health services that enhance the coping and well-being of parents whose babies excessively cry. Related aims were to improve these infants' outcomes and how NHS money is spent. ⋯ Parents and HVs/SCPHNs recognise the need for NHS provisions that support parents of excessively crying babies and consider the materials developed to meet that need. A full-scale randomised controlled trial is feasible and desirable.
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Health Technol Assess · Oct 2019
Randomized Controlled Trial Multicenter Study Clinical TrialThe AMBER care bundle for hospital inpatients with uncertain recovery nearing the end of life: the ImproveCare feasibility cluster RCT.
Patients admitted to hospital with a terminal illness and uncertain recovery often receive inconsistent care and do not have the opportunity to die in their preferred place of death. Previous end-of-life care packages, such as the Liverpool Care Pathway for the Dying Patient, have sometimes been badly implemented. The AMBER (Assessment; Management; Best practice; Engagement; Recovery uncertain) care bundle was developed to remedy this. It has not been evaluated in a randomised trial, but a definitive trial would face many hurdles. ⋯ This feasibility trial has demonstrated that an evaluation of the AMBER care bundle among an acutely unwell patient population, although technically possible, is not practical or feasible. The intervention requires optimisation.
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Health Technol Assess · Oct 2019
Clinical Trial Observational StudyAn intervention to improve outcomes of falls in dementia: the DIFRID mixed-methods feasibility study.
Fall-related injuries are a significant cause of morbidity and mortality in people with dementia. There is presently little evidence to guide the management of such injuries, and yet there are potentially substantial benefits to be gained if the outcomes of these injuries could be improved. This study aimed to design an appropriate new health-care intervention for people with dementia following a fall and to assess the feasibility of its delivery in the UK NHS. ⋯ The study has highlighted the feasibility of delivering a creative, tailored, individual approach to intervention for people with dementia following a fall. Although the intervention required greater investment of time than usual practice, many staff valued the opportunity to work more closely with people with dementia and their carers. We conclude that further research is now needed to refine this intervention in the context of a pilot randomised controlled trial.