Electronic case report forms and electronic data capture within clinical trials and pharmacoepidemiology

Rorie, David; Flynn, Robert; Grieve, Kerr; Doney, Alex S.F.; Mackenzie, Isla S.; MacDonald, Thomas M.; Rogers, Amy

doi:10.1111/bcp.13285

Cited by 29 publications

(21 citation statements)

References 63 publications

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“…Randomised controlled trials are the most reliable method of evaluating the efficacy or safety of a drug therapy [ 1 ]. Research and clinical studies have evolved to the use of the newest technologies and methodologies, with electronic data capture (EDC) now being commonplace and preferable [ 2 – 5 ]. In parallel, email use has quickly developed to replace face-to-face consultations [ 6 – 8 ] and study screening visits [ 9 ].…”

Section: Introductionmentioning

confidence: 99%

The Treatment In Morning versus Evening (TIME) study: analysis of recruitment, follow-up and retention rates post-recruitment

Rorie

Flynn

Mackenzie

et al. 2017

Trials

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BackgroundThe use of information technology (IT) is now the preferred method of capturing and storing clinical research data. The Treatment In Morning versus Evening (TIME) study predominantly uses electronic data capture and IT to compare morning dosing of hypertensive medication against evening dosing. Registration, consent, participant demographics and follow-up data are all captured via the study website. The aim of this article is to assess the success of the TIME methodology compared with similar studies.MethodsTo assess the TIME study, published literature on similar clinical trials was reviewed and compared against TIME recruitment, follow-up and email interaction data.ResultsThe TIME website registered 31,695 individuals, 21,116 of whom were randomised. Recruitment cost per randomised participant varied by strategy: £17.40 by GP practice, £3.08 by UK Biobank and £58.82 for GoShare. Twelve-month follow-up retention rates were 96%. A total of 1089 participants have withdrawn from their assigned time of dosing, 2% of whom have declined follow-up by record linkage or further contact. When the TIME data are compared with similar study data, study recruitment is very successful. However, TIME suffers difficulties with participant follow-up and withdrawal rates similar to those of conventional studies.ConclusionsThe TIME study has been successful in recruitment. Follow-up, retention rates and withdrawal rates are all acceptable, but ongoing work is required to ensure participants remain engaged with the study. Various recruitment strategies are necessary, and all viable options should be encouraged to maintain participant engagement throughout the life of studies using IT.

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Section: Introductionmentioning

confidence: 99%

The Treatment In Morning versus Evening (TIME) study: analysis of recruitment, follow-up and retention rates post-recruitment

Rorie

Flynn

Mackenzie

et al. 2017

Trials

Self Cite

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“…In this study, we designed the architecture for mHealth and verified the performance in a clinical study. Although mHealth is suitable for collecting medical data, such as patient reported outcomes [46], by changing the client device from patients’ mobile phone to computers in medical institutions, the system can also be applied to clinical trials that use electronic data capture [47]. In addition, we could deploy smart contract, which is called chaincode in Hyperledger Fabric, to each node of the blockchain network to execute transactions.…”

Section: Discussionmentioning

confidence: 99%

Secure and Scalable mHealth Data Management Using Blockchain Combined With Client Hashchain: System Design and Validation

et al. 2019

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Background Blockchain is emerging as an innovative technology for secure data management in many areas, including medical practice. A distributed blockchain network is tolerant against network fault, and the registered data are resistant to tampering and revision. The technology has a high affinity with digital medicine like mobile health (mHealth) and provides reliability to the medical data without labor-intensive third-party contributions. On the other hand, the reliability of the medical data is not insured before registration to the blockchain network. Furthermore, there are issues with regard to how the clients' mobile devices should be dealt with and authenticated in the blockchain network in order to avoid impersonation. Objective The aim of the study was to design and validate an mHealth system that enables the compatibility of the security and scalability of the medical data using blockchain technology. Methods We designed an mHealth system that sends medical data to the blockchain network via relay servers. The architecture provides scalability and convenience of operation of the system. In order to ensure the reliability of the data from clients' mobile devices, hash values with chain structure (client hashchain) were calculated in the clients' devices and the results were registered on the blockchain network. Results The system was applied and deployed in mHealth for insomnia treatment. Clinical trials for mHealth were conducted with insomnia patients. Medical data of the recruited patients were successfully registered with the blockchain network via relay servers along with the hashchain calculated on the clients' mobile devices. The correctness of the data was validated by identifying illegal data, which were made by simulating fraudulent access. Conclusions Our proposed mHealth system, blockchain combined with client hashchain, ensures compatibility of security and scalability in the data management of mHealth medical practice. Trial Registration UMIN Clinical Trials Registry UMIN000032951; https://upload.umin.ac.jp/cgi-open- bin/ctr_e/ctr_view.cgi?recptno=R000037564 (Archived by WebCite at http://www.webcitation.org/78HP5iFIw)

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“…The training of recording data with eCRFs/EDCS is an important factor for the success of a study. 20 Start-up meetings, personalised education and training visits assist in improving recruitment. 25 …”

Section: Discussionmentioning

confidence: 99%

“… 19 The training how to deal with eCRFs is a very important aspect; all participants should understand how to use the EDCS. 20 …”

Section: Introductionmentioning

confidence: 99%

Acceptability of a German multicentre healthcare research study: a survey of research personnels’ attitudes, experiences and work load

et al. 2018

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ObjectivesThe DACAPO study as a multicentre nationwide observational healthcare research study investigates the influence of quality of care on the quality of life in patients with acute respiratory distress syndrome. The aim of this study was to investigate the acceptability to the participating research personnels by assessing attitudes, experiences and workload associated with the conduct of the DACAPO study.Design, setting and participantsA prospective anonymous online survey was sent via email account to 169 participants in 65 study centres. The questionnaire included six different domains: (1) training for performing the study; (2) obtaining informed consent; (3) data collection; (4) data entry using the online documentation system; (5) opinion towards the study and (6) personal data. Descriptive data analysis was carried out.ResultsA total of 78 participants took part (46%) in the survey, 75 questionnaires (44%) could be evaluated. 51% were senior medical specialists. 95% considered the time frame of the training as appropriate and the presentation was rated by 93% as good or very good. Time effort for obtaining consent, data collection and entry was considered by 41% as a burden. Support from the coordinating study centre was rated as good or very good by more than 90% of respondents. While the DACAPO study was seen as scientifically relevant by 81%, only 45% considered the study results valuable for improving patient care significantly.ConclusionCollecting feedback on the acceptability of a large multicentre healthcare research study provided important insights. Recruitment and data acquisition was mainly performed by physicians and often regarded as additional time burden in clinical practice. Reducing the amount of data collection and simplifying data entry could facilitate the conduct of healthcare research studies and could improve motivation of researchers in intensive care medicine.Trial registration numberNCT02637011; Pre-results.

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Electronic case report forms and electronic data capture within clinical trials and pharmacoepidemiology

Cited by 29 publications

References 63 publications

The Treatment In Morning versus Evening (TIME) study: analysis of recruitment, follow-up and retention rates post-recruitment

The Treatment In Morning versus Evening (TIME) study: analysis of recruitment, follow-up and retention rates post-recruitment

Secure and Scalable mHealth Data Management Using Blockchain Combined With Client Hashchain: System Design and Validation

Acceptability of a German multicentre healthcare research study: a survey of research personnels’ attitudes, experiences and work load

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