scholarly journals Randomised evaluation of assertive community treatment: 3-year outcomes

2009 ◽  
Vol 195 (1) ◽  
pp. 81-82 ◽  
Author(s):  
Helen Killaspy ◽  
Stella Kingett ◽  
Paul Bebbington ◽  
Robert Blizard ◽  
Sonia Johnson ◽  
...  
Keyword(s):  
Assertive Community Treatment ◽  
Service Use ◽  
Controlled Trial ◽  
Community Treatment ◽  
Short Period ◽  
Randomised Controlled ◽  
The Uk ◽  
Patient Service ◽  
React Study

SummaryThe only randomised controlled trial to test high-fidelity assertive community treatment (ACT) in the UK (the Randomised Evaluation of Assertive Community Treatment (REACT) study) found no advantage over usual care from community mental health teams in reducing the need for inpatient care and in other clinical outcomes, but participants found ACT more acceptable and engaged better with it. One possible reason for the lack of efficacy of ACT might be the short period of follow-up (18 months in the REACT study). This paper reports on participants' service contact, in-patient service use and adverse events 36 months after randomisation.

scholarly journals Why are feasibility studies accessing routinely collected health data? A systematic review

F1000Research ◽  
2021 ◽  
Vol 10 ◽  
pp. 815
Author(s):  
Aziza Mirza ◽  
Victoria Yorke-Edwards ◽  
Sarah Lensen ◽  
Macey L. Murray ◽  
Carlos Diaz-Montana ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Feasibility Studies ◽  
Health Data ◽  
Patient Recruitment ◽  
Research And Innovation ◽  
Routinely Collected Health Data ◽  
Randomised Controlled ◽  
The Uk ◽  
National Databases

Background: Feasibility trials are often undertaken to determine whether a larger randomised controlled trial (RCT) is achievable. In a recent review, 15 feasibility trials accessed routinely collected health data (RCHD) from UK national databases and registries. This paper looks at attributes of these trials and the reasons why they accessed RCHD.  Methods: We extracted data from all publicly available sources for the 15 feasibility studies found in a previous review of trials successfully accessing RCHD in the UK between 2013–2018 for the purpose of informing or supplementing participant data. We extracted trial characteristics, the registry accessed, and the way the RCHD was used.  Results: The 15 feasibility RCTs were conducted in a variety of disease areas, and were generally small (median sample size 100, range 41–4061) and individually randomised (60%, 9/15). The primary trial outcome was predominantly administrative (non-clinical) (80%, 12/15) such as feasibility of patient recruitment. They were more likely to recruit from secondary care (67%, 10/15) settings than primary (33%, 5/15).  NHS Digital was the most commonly accessed registry (33% (5/15)) with SAIL databank (20% (3/15)), electronic Data Research and Innovation Service (eDRIS) and Paediatric Intensive Care Audit Network (PICANET) (each 13% 2/15) also being accessed. Where the information was clear, the trials used RCHD for data collection during the trial (47%, 7/15), follow-up after the trial (27%, 4/15) and recruitment (13%, 2/15).  Conclusions: Between 2013 and 2018, 15 feasibility trials successfully accessed UK RCHD. Feasibility trials would benefit, as with other trials, from guidance on reporting the use of RCHD in protocols and publications.

scholarly journals Community treatment orders: background and implications of the OCTET trial

2014 ◽  
Vol 38 (1) ◽  
pp. 3-5 ◽  
Author(s):  
Tom Burns ◽  
Andrew Molodynski
Keyword(s):  
Controlled Trial ◽  
Community Treatment ◽  
Community Treatment Orders ◽  
International Evidence ◽  
Obvious Benefit ◽  
Evaluation Trial ◽  
Randomised Controlled ◽  
The Uk ◽  
Treatment Order ◽  
Community Treatment Order

SummaryCommunity treatment orders (CTOs) were introduced into the UK despite unconvincing international evidence for their effectiveness. The Oxford Community Treatment Order Evaluation Trial (OCTET) is a multisite randomised controlled trial of 333 patients with psychosis conducted in the UK. It confirms an absence of any obvious benefit in reducing relapse despite significant curtailment of liberty. Community mental health teams need to seriously consider whether they should continue using CTOs or shift their clinical focus to strengthening the working alliance.

scholarly journals Individualised screening for diabetic retinopathy: the ISDR study—rationale, design and methodology for a randomised controlled trial comparing annual and individualised risk-based variable-interval screening

BMJ Open ◽  
2019 ◽  
Vol 9 (6) ◽  
pp. e025788 ◽  
Author(s):  
Deborah M Broadbent ◽  
Christopher J Sampson ◽  
Amu Wang ◽  
Lola Howard ◽  
Abigail E Williams ◽  
...  
Keyword(s):  
Diabetic Retinopathy ◽  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Screening Programme ◽  
Controlled Trial ◽  
Randomised Trial ◽  
Variable Interval ◽  
Randomised Controlled ◽  
The Uk

IntroductionCurrently, all people with diabetes (PWD) aged 12 years and over in the UK are invited for screening for diabetic retinopathy (DR) annually. Resources are not increasing despite a 5% increase in the numbers of PWD nationwide each year. We describe the rationale, design and methodology for a randomised controlled trial (RCT) evaluating the safety, acceptability and cost-effectiveness of personalised variable-interval risk-based screening for DR. This is the first randomised trial of personalised screening for DR and the largest ophthalmic RCT in the UK.Methods and analysisPWD attending seven screening clinics in the Liverpool Diabetic Eye Screening Programme were recruited into a single site RCT with a 1:1 allocation to individualised risk-based variable-interval or annual screening intervals. A risk calculation engine developed for the trial estimates the probability that an individual will develop referable disease (screen positive DR) within the next 6, 12 or 24 months using demographic, retinopathy and systemic risk factor data from primary care and screening programme records. Dynamic, secure, real-time data connections have been developed. The primary outcome is attendance for follow-up screening. We will test for equivalence in attendance rates between the two arms. Secondary outcomes are rates and severity of DR, visual outcomes, cost-effectiveness and health-related quality of life. The required sample size was 4460 PWD. Recruitment is complete, and the trial is in follow-up.Ethics and disseminationEthical approval was obtained from National Research Ethics Service Committee North West – Preston, reference 14/NW/0034. Results will be presented at international meetings and published in peer-reviewed journals. This pragmatic RCT will inform screening policy in the UK and elsewhere.Trial registration numberISRCTN87561257; Pre-results.

Economic evaluation of a crisis resolution service: A randomised controlled trial

2009 ◽  
Vol 18 (1) ◽  
pp. 54-58 ◽  
Author(s):  
Paul McCrone ◽  
Sonia Johnson ◽  
Fiona Nolan ◽  
Stephen Pilling ◽  
Andrew Sandor ◽  
...  
Keyword(s):  
Mental Health ◽  
Service Use ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Cost Effective ◽  
Primary Outcome Measure ◽  
Crisis Resolution ◽  
Randomised Controlled ◽  
The Impact

SummaryAims – The use of specialised services to avoid admission to hospital for people experiencing mental health crises is seen as an integral part of psychiatric services in some countries. The aim of this paper is to assess the impact on costs and costeffectiveness of a crisis resolution team (CRT). Methods – Patients who were experiencing mental health crises sufficient for admission to be considered were randomised to either care provided by a CRT or standard services. The primary outcome measure was inpatient days over a six-month follow-up period. Service use was measured, costs calculated and cost-effectiveness assessed. Results – Patients receiving care from the CRT had non-inpatient costs £768 higher than patients receiving standard care (90% CI, £153 to £1375). With the inclusion of inpatient costs the costs for the CRT group were £2438 lower for the CRT group (90% CI, £937 to £3922). If one less day spent as an inpatient was valued at £100, there would be a 99.5% likelihood of the CRT being costeffective. Conclusion – This CRT was shown to be cost-effective for modest values placed on reductions in inpatient stays.

scholarly journals Effects of canagliflozin are mostly observed at first follow-up, within 6 months of commencement: results for the ABCD canagliflozin audit

2020 ◽  
Vol 20 (2) ◽  
pp. 113-116
Author(s):  
Thomas SJ Crabtree ◽  
Peter Winocour ◽  
Ken Darzy ◽  
Suzanne Phillips ◽  
Alison Evans ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Trial Data ◽  
Randomised Control Trial ◽  
Baseline Hba1c ◽  
Beneficial Effects ◽  
Randomised Controlled ◽  
The Uk ◽  
Minimum Dataset ◽  
Trial Evidence

Introduction: Canagliflozin was initially approved for use in the UK in March 2013. Randomised control trial evidence has demonstrated multiple beneficial effects. Many of these are present at initial follow-up and within 26 weeks of randomised control trial data. Our aim was to assess whether the beneficial effects of canagliflozin on multiple clinical and biochemical parameters occurred prior to first follow-up and, if so, whether these continued to improve or simply persisted at second follow-up.Methods: Data were extracted from the ABCD nationwide canagliflozin audit to include a minimum dataset of a baseline value and one (or two) follow-ups for each value.Results: A total of 1,214 patient datasets were identified and used in the analysis: mean±SD age 60.1±10.6 years; median duration of diabetes 8 (IQR 2.4–12.6 years); baseline HbA1c 75.1±17.4 mmol/mol (9.0±1.59%) and weight 97.8±22.0 kg. 68.3% of the patients were Caucasian where this was known (n=183). At first follow-up (median 0.7 years) from baseline: change in HbA1c −9.3 mmol/mol (95% CI −8.2 to −10.4; p<0.0001), weight −2.3 kg (95% CI −1.9 to −2.5; p<0.0001); BMI −0.7 kg/m2 (95% CI −0.6 to −0.8; p<0.0001); alanine aminotransferase −2 U/L (95% CI −1.3 to −2.7; p<0.0001); eGFR −0.9 mL/min/1.73 m2 (95% CI −0.4 to −1.4; p<0.001); systolic blood pressure (BP) −2.6 mmHg (95% CI −1.6 to −3.5; p<0.0001) and diastolic BP −0.9 mmHg (95% CI −0.2 to −1.6; p<0.001). Significant differences persisted comparing second follow-up (median 1.2 years) to baseline, but no further significant changes were noted between first follow-up and second follow-up other than in weight and BMI with further change in weight −0.65 kg (95% CI −0.2 to −1.1; p=0.047).Conclusion: The improvements following canagliflozin in this real-world cohort seem to occur within the first 0.7 years of treatment, which is similar to randomised controlled trial data. These improvements seem to be maintained over the next 6 months, with significant further weight loss occurring between 0.7 years and 1.2 years, although the mechanism of this is unclear and might be due to confounders. More evidence on this point is needed.

scholarly journals Evaluating the effectiveness of the smartphone app, Drink Less, compared with the NHS alcohol advice webpage, for the reduction of alcohol consumption among hazardous and harmful adult drinkers in the UK at six-month follow-up: protocol for a randomised controlled trial

2020 ◽  
Author(s):  
Claire Garnett ◽  
Melissa Oldham ◽  
Colin Angus ◽  
Emma Beard ◽  
Robyn Burton ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Alcohol Consumption ◽  
Large Scale ◽  
Controlled Trial ◽  
Economic Evaluations ◽  
Intention To Treat ◽  
Randomised Controlled ◽  
The Uk

AbstractBackground and AimsDigital interventions are effective for reducing alcohol consumption but evidence is limited regarding smartphone apps. Drink Less is a theory- and evidence-informed app to help people reduce their alcohol consumption that has been refined in terms of its content and design for usability across the socio-demographic spectrum. We aim to evaluate the effectiveness and cost-effectiveness of recommending Drink Less at reducing alcohol consumption compared with usual digital care.DesignTwo-arm individually randomised controlled trial.SettingOnline trial in the UK.ParticipantsHazardous or harmful drinkers (Alcohol Use Disorders Identification Test score >=8) aged 18+, and want to drink less alcohol (n=5,562). Participants will be recruited from July 2020 to May 2022 using multiple strategies with a focus on remote digital methods.Intervention and comparatorParticipants will be randomised to receive either an email recommending that they use Drink Less (intervention) or view the NHS webpage on alcohol advice (comparator).MeasurementsThe primary outcome is change in self-reported weekly alcohol consumption between baseline and 6-month follow-up. Secondary outcomes include the proportion of hazardous drinkers; alcohol-related problems and injury; health-related quality of life, and use of health services assessed at 6-month follow-up. Effectiveness will be examined with one-way ANCOVAs, adjusting for baseline alcohol consumption, and using an intention-to-treat approach. A mixed-methods process evaluation will assess engagement, acceptability and mechanism of action. Economic evaluations will be conducted using both a short- and longer-term time horizon.CommentsThis study will establish the effectiveness and cost-effectiveness of the Drink Less app at reducing alcohol consumption among hazardous and harmful adult drinkers and will be the first RCT of an alcohol reduction app for the general population in the UK. This study will inform the decision on whether it is worth investing resources in large-scale implementation.

scholarly journals Long term effects of once-only flexible sigmoidoscopy screening after 17 years of follow-up: the UK Flexible Sigmoidoscopy Screening randomised controlled trial

The Lancet ◽  
2017 ◽  
Vol 389 (10076) ◽  
pp. 1299-1311 ◽  
Author(s):  
Wendy Atkin ◽  
Kate Wooldrage ◽  
D Maxwell Parkin ◽  
Ines Kralj-Hans ◽  
Eilidh MacRae ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Flexible Sigmoidoscopy ◽  
Controlled Trial ◽  
Long Term Effects ◽  
Randomised Controlled ◽  
The Uk
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