Are the barriers of patients using their own mobile devices, myth or reality?

It is unclear whether “Bring your own device”  BYOD, will lead to significant cost savings, but reducing logistics is likely to make study management less complex. More importantly, BYOD promises greater patient-centricity by enabling patients to conduct assessments using the convenience and familiarity of their own hardware devices. BYOD is a topic often discussed in the context of electronic clinical outcome assessments (eCOA) but there has been limited use of BYOD in regulatory studies to date and common perception is that delay in uptake is from two main concerns: 

  • Measurement equivalence: The differences in the eCOA instrument display due to device screen size and resolution might adversely affect its measurement properties.
  • Technical and practical issues: Lack of control of the patient’s hardware, for example being unable to prevent operating system upgrades mid-study, or having no control over the device storage space availability.


BYOD Survey

In order to identify and assess the perceived barriers and challenges with the use of BYOD for eCOA, ICON in association with Medidata and mProve Health decided to conduct a survey. This comprehensive survey, of industry clinical trial and outcomes research specialists, highlighted how commonly-cited concerns around the use of patients’ own devices are not as great a deterrent to adoption as originally thought.  

Seventy-nine respondents, from a range of organisations including biopharma companies (18%), CROs (23%) and eCOA vendors (34%), completed our survey in autumn 2015. 

Attitudes towards measurement equivalence

Less than half the respondents (44%) agreed or strongly agreed that equivalence should be demonstrated on all possible devices used in a BYOD study; and a third (33%) disagreed or strongly disagreed that demonstration of equivalence on a single device was acceptable if access using devices of a smaller screen size or resolution could be prevented. 

This echoes the growing body of evidence that equivalence across modalities and screen sizes is less problematic than previously thought, especially if eCOA design best practices are employed [1].  For example, a recent meta-analysis by ICON eCOA experts has demonstrated strong evidence of the equivalence of paper and electronic over multiple instruments, patient populations and electronic media [2].  If patients respond consistently with COA instruments, whether in paper or electronic form, then it seems a reasonable inference that the subtle changes across different mobile phones should not present a significant equivalence challenge.

Attitudes towards perceived technical and practical issues

Of the 21 perceived practical/technical challenges and issues associated with BYOD use for eCOA that we considered, few appeared of significant concern to the respondents in this survey.  In all cases, over half of the respondents were either “not at all concerned” or “a little concerned” on the 4-point verbal response scale.  Those reporting slightly more concern included:

  • The ability of patients to disable in-app notifications, such as diary reminders (53%:  “not at all concerned” or “a little concerned”)
  • The ability of patients to pair their phone with a BlueTooth device when required by the study (32%: “very concerned” or “extremely concerned”)
  • Patient training and technical troubleshooting by the site personnel (Training burden on sites – 27% “very concerned” or “extremely concerned”; Site troubleshooting technical issues – 33% “very concerned” or “extremely concerned”).

While some concerns explored are tangible situations that could occur in a clinical trial, many can be mitigated or balanced against the benefits of enabling patients to use their own familiar and convenient devices, which may actually lead to greater compliance and engagement. For example, it is possible to identify when push notification tokens indicate that in-app notifications have been disabled on the patient’s device, and this could enable other actions to contact the patient if their compliance with the diary schedule is an issue.

Conclusion

The results of this survey are encouraging and indicate a greater comfort in BYOD, and with it the opportunity for patient convenience and centricity – enabling subjects to utilise their own smartphone to maintain their symptom diaries and instrument entries – the device they already carry with them and refer to over the course of each day. With BYOD, subjects will use a device they are familiar with and know how to use, and will not be inconvenienced by needing to carry and keep charged a separate device solely for the purposes of their eCOA entries. Previous patient preference studies have shown that the majority of patients prefer to have a single device, and this can only benefit PRO convenience, completion and compliance.

The FDA’s request for public input on the scope and direction of the use of technologies and innovative methods in the conduct of clinical investigations [3], closed in December 2015, includes a specific question concerning the use of BYOD eCOA. This is a positive signal from the regulators and can only help to provide better understanding of FDAs position and what additional research and development work might be needed to make BYOD a fully endorsed approach.

At ICON, we believe that we are about to enter the age of BYOD eCOA. We continue to drive research and development activity and share our findings around the use of BYOD, to help to turn the tide and improve patient engagement in clinical trials. 


References

[1] C-PATH Institute ePRO Consortium (2014). Best Practices for Electronic Implementation of Patient-Reported Outcome Response Scale Options.  http://c-path.org/wp-content/uploads/2014/05/BestPracticesForElectronicImplementationOfPROResponseScaleOptions.pdf).

[2] Muehlhausen W. et al. (2015). Equivalence of electronic and paper administration of  patient-reported outcome measures: a systematic review and meta-analysis of studies conducted between 2007 and  2013.  Health and Quality of Life Outcomes; 13: 167-187. http://hqlo.biomedcentral.com/articles/10.1186/s12955-015-0362-x

[3] Federal Register (2015).  Using Technologies and Innovative Methods to Conduct Food and Drug Administration-Regulated Clinical Investigations of Investigational Drugs; Establishment of a Public Docket. https://www.federalregister.gov/articles/2015/10/29/2015-27581/using-technologies-and-innovative-methods-to-conduct-food-and-drug-administration-regulated-clinical