eSource for clinical trials: Implementation and evaluation of a standards-based approach in a real world trial

Éthier, Jean-François; Ćurčin, Vasa; McGilchrist, Mark; Keung, Sarah Niukyun Lim Choi; Zhao, Lei; Andréasson, Anna; Bródka, Piotr; Michalski, Radosław; Arvanitis, Theodoros N.; Mastellos, Nikolaos; Burgun, Anita; Delaney, Brendan

doi:10.1016/j.ijmedinf.2017.06.006

Cited by 29 publications

(25 citation statements)

References 30 publications

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“…Among the 11 studies that evaluated digital tools for both recruitment and retention, five (45%) used different digital tools for recruitment and for retention [79,80,97,104,162]. Four studies employed at least one digital tool that was common to both recruitment and retention, i.e.…”

Section: Characteristics Of the Studiesmentioning

confidence: 99%

“…However, the map shows that most of the studies (81%) have evaluated digital tools only for recruitment. Where studies did utilise digital tools both for recruitment and retention the tools that they used for recruitment and retention were different [73,79,80,97,104,106,126,139,162]. This is not surprising, since the approaches for recruitment were primarily to raise Fig.…”

Section: Links Between Recruitment Retention and Other Digital Aspects Of Trial Managementmentioning

confidence: 99%

“…However, according to the study publications, several of the studies in the map that evaluated digital tools for both recruitment and retention had included further digital methods for other purposes. These digital methods covered: online patient verification [79,80]; online randomisation [73,104]; allocation concealment [73]; automated data collection [73,104]; information dissemination from investigators to participants [104]; email and website options for participants to contact investigators [139]; data monitoring and tracing [97]; and dataquality checking [73]. A key question is whether the efficiency of clinical trials could be improved by developing a small set of compatible digital tools that would cover all of these aspects of trial management, rather than requiring trial investigators to select separate digital tools to cover recruitment, retention and other aspects of trial management.…”

Section: Links Between Recruitment Retention and Other Digital Aspects Of Trial Managementmentioning

confidence: 99%

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Digital tools for the recruitment and retention of participants in randomised controlled trials: a systematic map

Frampton

Shepherd

Pickett

et al. 2020

Trials

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Background: Recruiting and retaining participants in randomised controlled trials (RCTs) is challenging. Digital tools, such as social media, data mining, email or text-messaging, could improve recruitment or retention, but an overview of this research area is lacking. We aimed to systematically map the characteristics of digital recruitment and retention tools for RCTs, and the features of the comparative studies that have evaluated the effectiveness of these tools during the past 10 years. Methods: We searched Medline, Embase, other databases, the Internet, and relevant web sites in July 2018 to identify comparative studies of digital tools for recruiting and/or retaining participants in health RCTs. Two reviewers independently screened references against protocol-specified eligibility criteria. Included studies were coded by one reviewer with 20% checked by a second reviewer, using pre-defined keywords to describe characteristics of the studies, populations and digital tools evaluated.Results: We identified 9163 potentially relevant references, of which 104 articles reporting 105 comparative studies were included in the systematic map. The number of published studies on digital tools has doubled in the past decade, but most studies evaluated digital tools for recruitment rather than retention. The key health areas investigated were health promotion, cancers, circulatory system diseases and mental health. Few studies focussed on minority or under-served populations, and most studies were observational. The most frequently-studied digital tools were social media, Internet sites, email and tv/radio for recruitment; and email and text-messaging for retention. One quarter of the studies measured efficiency (cost per recruited or retained participant) but few studies have evaluated people's attitudes towards the use of digital tools.Conclusions: This systematic map highlights a number of evidence gaps and may help stakeholders to identify and prioritise further research needs. In particular, there is a need for rigorous research on the efficiency of the digital tools and their impact on RCT participants and investigators, perhaps as studies-within-a-trial (SWAT) research. There is also a need for research into how digital tools may improve participant retention in RCTs which is currently underrepresented relative to recruitment research.

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Section: Characteristics Of the Studiesmentioning

confidence: 99%

Section: Links Between Recruitment Retention and Other Digital Aspects Of Trial Managementmentioning

confidence: 99%

Section: Links Between Recruitment Retention and Other Digital Aspects Of Trial Managementmentioning

confidence: 99%

See 1 more Smart Citation

Digital tools for the recruitment and retention of participants in randomised controlled trials: a systematic map

Frampton

Shepherd

Pickett

et al. 2020

Trials

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“…and to be deployed on the TRANSFoRM platform. Study recruited over 600 patients in 4 countries (Poland, Greece, UK, Netherlands) and 5 different EHR Software suites …”

Section: The Transform Experiencementioning

confidence: 99%

The TRANSFoRm project: Experience and lessons learned regarding functional and interoperability requirements to support primary care

Éthier

McGilchrist

Barton

et al. 2017

Learning Health Systems

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“…The Translational Research and Patient Safety in Europe (TRANSFoRm) project aims to reduce barriers to conducting research using routine healthcare data across Europe 8 – 10. The European eHealth Action Plan prioritises interoperability between health records so that internationally comparable data can be collected on the quality of care and for research 11.…”

Section: Introductionmentioning

confidence: 99%

An instrument to identify computerised primary care research networks, genetic and disease registries prepared to conduct linked research: TRANSFoRm International Research Readiness (TIRRE) survey

Jennings

Lusignan²,

Michalakidis

et al. 2018

BMJ Health Care Inform

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PurposeThe Translational Research and Patients safety in Europe (TRANSFoRm) project aims to integrate primary care with clinical research whilst improving patient safety. The TRANSFoRm International Research Readiness survey (TIRRE) aims to demonstrate data use through two linked data studies and by identifying clinical data repositories and genetic databases or disease registries prepared to participate in linked research.MethodThe TIRRE survey collects data at micro-, meso- and macro-levels of granularity; to fulfil data, study specific, business, geographical and readiness requirements of potential data providers for the TRANSFoRm demonstration studies. We used descriptive statistics to differentiate between demonstration-study compliant and non-compliant repositories. We only included surveys with >70% of questions answered in our final analysis, reporting the odds ratio (OR) of positive responses associated with a demonstration-study compliant data provider.ResultsWe contacted 531 organisations within the Eurpean Union (EU). Two declined to supply information; 56 made a valid response and a further 26 made a partial response. Of the 56 valid responses, 29 were databases of primary care data, 12 were genetic databases and 15 were cancer registries. The demonstration compliant primary care sites made 2098 positive responses compared with 268 in non-use-case compliant data sources [OR: 4.59, 95% confidence interval (CI): 3.93–5.35, p < 0.008]; for genetic databases: 380:44 (OR: 6.13, 95% CI: 4.25–8.85, p < 0.008) and cancer registries: 553:44 (OR: 5.87, 95% CI: 4.13–8.34, p < 0.008).ConclusionsTIRRE comprehensively assesses the preparedness of data repositories to participate in specific research projects. Multiple contacts about hypothetical participation in research identified few potential sites.

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eSource for clinical trials: Implementation and evaluation of a standards-based approach in a real world trial

Cited by 29 publications

References 30 publications

Digital tools for the recruitment and retention of participants in randomised controlled trials: a systematic map

Digital tools for the recruitment and retention of participants in randomised controlled trials: a systematic map

The TRANSFoRm project: Experience and lessons learned regarding functional and interoperability requirements to support primary care

An instrument to identify computerised primary care research networks, genetic and disease registries prepared to conduct linked research: TRANSFoRm International Research Readiness (TIRRE) survey

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