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What to consider when designing smartphone patient centred studies?

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Date: 6/3/2017

Contributors: Angela Rylands and Catherine Bottomley


The use of a patients' own smartphone to collect patient centred data in studies is growing rapidly in popularity, however, the adoption of such a technique is not without its limitations.

The concept of BYOD (bring your own device) in studies potentially facilitates the collection of patient centred outcome data and offers an attractive alternative to paper based data collection. The question remains as to whether the BYOD method can be relied upon to produce data that is as valid and reliable as the data obtained from more traditional methods of patient reported (PRO) and clinician reported (ClinRO) outcome data collection studies.

Fortunately the ePRO Consortium (Critical Path Institute https://c-path.org/programs/epro/) has previously published an important review (Gwaltney et al. 2015) which has helped shape BYOD study design since its publication. The consortium's review paper outlines key considerations for field-based data collection in clinical trials, and thereby set the standard for broader patient centred BYOD data collection.

The authors describe the importance of considering operational issues in BYOD study design according to three main principles: first to identify the configuration and set-up needs required for a BYOD study. Second, the authors highlight the importance of considering issues regarding security and privacy of information when using personal devices. Finally, the authors emphasise the need to consider how regulators will perceive BYOD approaches and they also speculate how BYOD will compare to more established ePRO methods, an area that already has existing publications around equivalence and with considerations for study design (e.g. O'Donohoe et al. 2015, Fuller et al. 2015).

Given the data collection method of BYOD is growing so rapidly, when embarking upon a patient centred study design, it is important to carefully consider the recommendations outlined in the review paper described here, and most importantly stakeholders in embarking upon BYOD methodology should work to gather empirical evidence on BYOD and share that information in public forums.

Please contact us for more information: AngelaRylands@phassociates.com or CatherineBottomley@phassociates.com

References:

Gwaltney C, Coons SJ, O'Donohoe P, O'Gorman H, Denomey M, Howry C, Ross J, on behalf of the ePRO Consortium. "Bring Your Own Device" (BYOD): The Future of Field-Based Patient-Reported Outcome Data Collection in Clinical Trials? Therapeutic Innovation & Regulatory Science. 2015;49(6):783-91.http://journals.sagepub.com/doi/abs/10.1177/2168479015609104

O'Donohoe P, Lundy JJ, Gnanasakthy A, Greene A, on behalf of the Patient-Reported Outcome (PRO) Consortium and ePRO Consortium at the Critical Path Institute. Considerations for Requiring Subjects to Provide a Response to Electronic Patient-Reported Outcome Instruments. Therapeutic Innovation & Regulatory Science. 2015;49(6):792-6.http://journals.sagepub.com/doi/abs/10.1177/2168479015609647

Fuller, RLM, McNamara CW, Lenderking, WR, Edgar C, Rylands A, Feaster, T, Sabatino D, Miller, DS. Establishing equivalence of electronic clinician-reported outcome measures. Therapeutic Innovation & Regulatory Science. 2015; 50(1): http://dij.sagepub.com/content/early/2015/12/09/2168479015618693.abstract

 

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