Seminars may increase recruitment to randomised controlled trials: lessons learned from WISDOM

Paine, Bronwen J; Stocks, Nigel; MacLennan, Alastair H.

doi:10.1186/1745-6215-9-5

Cited by 9 publications

(5 citation statements)

References 8 publications

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“…The overall acceptance rate in the UKCTOCS was similar to that seen in the colorectal cancer screening trial at Dundee and the WISDOM trial involving estrogen use after the menopause. 24 25 These rates were substantially higher than the 4.3% acceptance rate reported after a mass mailing of more than 3.4 million in the US systolic hypertension (SHEP) trial. 13 However, they were much lower than the 55% achieved in the UK FLEXISIG trial.…”

Section: Discussionmentioning

confidence: 90%

Recruitment to multicentre trials--lessons from UKCTOCS: descriptive study

Menon

Gentry‐Maharaj

Ryan

et al. 2008

BMJ

145

176

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Objective To describe the factors that contributed to successful recruitment of more than 200 000 women to the UK Collaborative Trial of Ovarian Cancer Screening, one of the largest ever randomised controlled trials. Design Descriptive study. Setting 13 NHS trusts in England, Wales, and Northern Ireland. Participants Postmenopausal women aged 50-74; exclusion criteria included ovarian malignancy, bilateral oophorectomy, increased risk of familial ovarian cancer, active non-ovarian malignancy, and participation in other ovarian cancer screening trials. Main outcome measures Achievement of target recruitment, acceptance rates of invitation, and recruitment rates. Results The trial was set up in 13 centres with 27 adjoining local health authorities. The coordinating centre team was led by one of the senior investigators, who was closely involved in planning and day to day trial management. Of 1 243 282 women invited, 23.2% (288 955) replied that they were eligible and would like to participate. Of those sent appointments, 73.6% (205 090) attended for recruitment. The acceptance rate varied from 19% to 33% between trial centres. Measures to ensure target recruitment included named coordinating centre staff supporting and monitoring each centre, prompt identification and resolution of logistic problems, varying the volume of invitations by centre, using local nonattendance rates to determine the size of recruitment clinics, and organising large ad hoc clinics supported by coordinating centre staff. The trial randomised 202 638 women in 4.3 years.

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Section: Discussionmentioning

confidence: 90%

Recruitment to multicentre trials--lessons from UKCTOCS: descriptive study

Menon

Gentry‐Maharaj

Ryan

et al. 2008

BMJ

145

176

View full text Add to dashboard Cite

show abstract

“…Although numbers are too small to draw conclusions, we do not have indications that the participation rate is higher in the hospitals that had a research nurse explaining the trial to the patient and her parent(s). Group seminars with potential participants may be a useful strategy for maximising recruitment (at least from general practices) [19]. For our trial, however, this would have been too complicated to carry out in practice, because there were only a couple of eligible patients per month, and they lived scattered over the whole country.…”

Section: Level Of the Patientmentioning

confidence: 99%

A randomised controlled trial on the effectiveness of bracing patients with idiopathic scoliosis: failure to include patients and lessons to be learnt

2010

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Trials often do not succeed in including as many patients as anticipated beforehand. The aim of this paper was to describe why we were not able to include more than a few patients in our randomized controlled treatment trial on the effectiveness of bracing patients with idiopathic scoliosis, and to describe which lessons can be learnt. A pilot study on the willingness to participate in such a trial was conducted amongst 21 patients and their parents. A description of how we prepared and designed this trial, the problems we faced and how we tried to improve the inclusion are given. A total of four patients were included, and 14 refused to participate in an 18-month period. There were a lot less eligible patients than anticipated (40 instead of 100 per year), and the patients' participation rate was much lower than we had found in our pilot study (21% instead of 70%). The trial failed to include more than a few patients because of an overestimation of the number of eligible patients and because a lot less eligible patients were willing to participate compared to our pilot study. One reason for a low participation rate could be that this trial evaluated a frequently used existing treatment instead of a new treatment, and patients and parents might be afraid of not being treated (despite an intensive secure system for the control arm).

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“…Recruitment to clinical trials in primary care can be challenging [ 1 ]. Recent papers in Trials have reported a variety of strategies to improve trial recruitment [ 2 - 4 ]. Drawing on the expanding field of health informatics, we report on a strategy to identify potential trial participants using routinely collected anonymised data that complements other approaches to this question [ 5 ].…”

Section: Introductionmentioning

confidence: 99%

The Health Informatics Trial Enhancement Project (HITE): Using routinely collected primary care data to identify potential participants for a depression trial

McGregor

Brooks

Chalasani

et al. 2010

Trials

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BackgroundRecruitment to clinical trials can be challenging. We identified anonymous potential participants to an existing pragmatic randomised controlled depression trial to assess the feasibility of using routinely collected data to identify potential trial participants. We discuss the strengths and limitations of this approach, assess its potential value, report challenges and ethical issues encountered.MethodsSwansea University's Health Information Research Unit's Secure Anonymised Information Linkage (SAIL) database of routinely collected health records was interrogated, using Structured Query Language (SQL). Read codes were used to create an algorithm of inclusion/exclusion criteria with which to identify suitable anonymous participants. Two independent clinicians rated the eligibility of the potential participants' identified. Inter-rater reliability was assessed using the kappa statistic and inter-class correlation.ResultsThe study population (N = 37263) comprised all adults registered at five general practices in Swansea UK. Using the algorithm 867 anonymous potential participants were identified. The sensitivity and specificity results > 0.9 suggested a high degree of accuracy from the algorithm. The inter-rater reliability results indicated strong agreement between the confirming raters. The Intra Class Correlation Coefficient (Cronbach's Alpha) > 0.9, suggested excellent agreement and Kappa coefficient > 0.8; almost perfect agreement.ConclusionsThis proof of concept study showed that routinely collected primary care data can be used to identify potential participants for a pragmatic randomised controlled trial of folate augmentation of antidepressant therapy for the treatment of depression. Further work will be needed to assess generalisability to other conditions and settings and the inclusion of this approach to support Electronic Enhanced Recruitment (EER).

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Seminars may increase recruitment to randomised controlled trials: lessons learned from WISDOM

Abstract: Background: Recruiting patients to large randomised controlled trials (RCTs) in the primary care setting can be challenging. Research teams need to identify and utilise strategies that both maximise the efficiency of recruitment and minimise the burden on general practitioners.

Cited by 9 publications

References 8 publications

Recruitment to multicentre trials--lessons from UKCTOCS: descriptive study

Recruitment to multicentre trials--lessons from UKCTOCS: descriptive study

A randomised controlled trial on the effectiveness of bracing patients with idiopathic scoliosis: failure to include patients and lessons to be learnt

The Health Informatics Trial Enhancement Project (HITE): Using routinely collected primary care data to identify potential participants for a depression trial

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