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 Access to routinely collected health data for clinical trials – review of successful data requests to UK registries

2020 ◽  
Author(s):  
Sarah Lensen ◽  
Archie Macnair ◽  
Sharon B Love ◽  
Victoria Yorke-Edwards ◽  
Nurulamin M Noor ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Data Extraction ◽  
Health Data ◽  
Lack Of Information ◽  
Routinely Collected Health Data ◽  
Long Term Follow Up ◽  
Randomised Controlled ◽  
The Uk

ABSTRACTBackgroundClinical trials generally each collect their own data despite routinely-collected health data (RCHD) increasing in quality and breadth. Our aim is to quantify UK-based randomised controlled trials (RCTs) accessing RCHD for participant data, characterise how these data are used and thereby recommend how more trials could use RCHD.MethodsWe conducted a systematic review of RCTs accessing RCHD from at least one registry in the UK between 2013-2018, for the purposes of informing or supplementing participant data. A list of all registries holding RCHD in the UK was compiled. In cases where registries published release registers, these were searched for RCTs accessing RCHD. Where no release register was available, registries were contacted to request a list of RCTs. For each identified RCT, information was collected from all publicly available sources (release registers, websites, protocol etc.). The search and data extraction was undertaken between Jan-2019 and May-2019.ResultsWe identified 160 RCTs accessing RCHD between 2013 and 2018 from a total of 22 registries; this corresponds to only a very small proportion of all UK RCTs (approximately 3%). RCTs accessing RCHD were generally large (median sample size 1590), commonly evaluating treatments for cancer or cardiovascular disease. Most of the included RCTs accessed RCHD from NHS Digital (68%), and the most frequently accessed datasets were mortality (76%) and hospital visits (55%). RCHD was used to inform the primary trial (82%) and long-term follow-up (57%). There was substantial variation in how RCTs used RCHD to inform participant outcome measures. A limitation was the lack of information and transparency from registries and RCTs with respect to which datasets have been accessed and for what purposes.ConclusionsIn the last five years, only a small minority of UK-based RCTs have accessed RCHD to inform participant data. We ask for improved accessibility, confirmed data quality and joined up thinking between the registries and the regulatory authorities.RegistrationPROSPERO CRD42019123088

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.

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 Are some feasibility studies more feasible than others? A review of the outcomes of feasibility studies on the ISRCTN registry

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Ben Morgan ◽  
Jennie Hejdenberg ◽  
Kasia Kuleszewicz ◽  
David Armstrong ◽  
Sue Ziebland
Keyword(s):  
Randomised Controlled Trials ◽  
Controlled Trial ◽  
Feasibility Studies ◽  
Research Setting ◽  
Topic Area ◽  
Published Evidence ◽  
Randomised Controlled ◽  
The Uk ◽  
Keyword Searches ◽  
Full Trial

Abstract Background Feasibility studies are often conducted before committing to a randomised controlled trial (RCT), yet there is little published evidence to inform how useful feasibility studies are, especially in terms of adding or reducing waste in research. This study attempted to examine how many feasibility studies demonstrated that the full trial was feasible and whether some feasibility studies were inherently likely to be feasible or not feasible, based on the topic area and/or research setting. Methods Keyword searches were conducted on the International Standard Randomised Controlled Trials Number (ISRCTN) registry to identify all completed feasibility studies which had been conducted in the UK. Results A total of 625 records from the 1933 identified were reviewed before it became evident that it would be futile to continue. Of 329 feasibility studies identified, 160 had a known outcome (49%), 133 (83%) trials were deemed to be feasible and only 27 (17%) were reported to be non-feasible. There were therefore too few studies to allow the intended comparison of differences in non-feasible studies by topic and/or setting. Conclusions There were too few studies reported as non-feasible to draw any useful conclusions on whether topic and/or setting had an effect. However, the high feasibility rate (83%) may suggest that non-feasible studies are subject to publication bias or that many feasible studies are redundant and may be adding waste to the research pathway.

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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