Designing trials for digital health solutions

Introduction

Despite the availability of evidence-based treatment guidelines and effective therapies for asthma, poor adherence to treatment^1,2 and lack of guideline implementation into daily practice³ remain significant barriers to asthma control. Telemedicine and other digital health solutions, such as mHealth applications, are increasingly seen as routes to better management of respiratory conditions such as asthma, especially to address poor adherence.⁴

However, despite their promise, there remains a lack of rigorous, high-quality evidence supporting the efficacy of such digital health solutions.⁵

Click the sections below to learn more about why we need improved studies for digital health solutions and how we can improve them.

Why do we need improved studies for novel digital health solutions?

Rapid advances in technology may lead to increased use of digital tools throughout respiratory care, but new tools need validation and evaluation to confirm they are effective. Guidelines that describe the key elements necessary in studies describing and evaluating new digital novel digital health solutions do exist,^5–7 but many studies do not measure up to these standards. Current studies often have to be interpreted with caution, as they may:^4,8

• Be of short duration (sometimes as little as 3 weeks) – longer follow-up periods are needed to assess medium to long-term benefits of digital health solutions and to determine if benefits are sustained over time
• Fail to describe in sufficient detail the features of the technologies or how they were evaluated
• Lack an appropriate control group

How can we improve studies involving novel digital health solutions?

Trials should incorporate the use of objective assessments of medication adherence via electronic monitoring devices, validated patient-reported outcomes such as Asthma Control Test (ACT) scores and objective outcome measures such as rescue medication use and spirometry where possible⁸

To avoid the restricted entry criteria that often characterise traditional trials of medications, studies of digital health solutions should reflect the user base and the usual clinical environment. They should not simply study early technology adopters using teaching hospitals⁴

Innovative trial designs such as randomised cluster site analysis (as used in the MAGNIFY trial⁹) may help provide data reflecting real-life situations and minimise bias, while the use of adaptive designs will better facilitate the evaluation of multiple solutions¹⁰

Collaborative design of trials to ensure technologies are both clinically effective and cost-effective will ensure digital approaches to disease management are supported by strong evidence,^4,8 and have the best chance of uptake to improve patient outcomes

Glossary

Early technology adopter

An early customer of a given technology or product, often before the product reaches mass market.

Collaborative trial design

Trial designs based on input and evidence from multiple parties, including primary care clinicians, healthcare organisations and digital technology stakeholders.

References

1. Global Initiative for Asthma (GINA 2020). Global strategy for asthma management and prevention. Last accessed September 2020. Available from: www.ginasthma.org.
2. Asthma UK. Connected asthma: how technology will transform care. Last accessed December 2019. Available from: https://www.asthma.org.uk/f29019fc/globalassets/get-involved/external-affairs-campaigns/publications/connected-asthma/connected-asthma---aug-2016.pdf
3. Chapman KR, Hinds D, Piazza P, et al. Physician perspectives on the burden and management of asthma in six countries: The Global Asthma Physician Survey (GAPS). BMC Pulm Med 2017;17:153.
4. Blakey JD, Bender BG, Dima AL, et al. Digital technologies and adherence in respiratory diseases: the road ahead. Eur Respir J 2018;52:1801147.
5. Agarwal S, LeFevre AE, Lee J, et al. Guidelines for reporting of health interventions using mobile phones: mobile health (mHealth) evidence reporting and assessment (mERA) checklist. BMJ 2016;352:i1174.
6. Murray E, Hekler EB, Andersson G, et al. Evaluating digital health interventions: key questions and approaches. Am J Prev Med 2016;51:843–51.
7. Eysenbach G, Group C-E. CONSORT-EHEALTH: improving and standardizing evaluation reports of web-based and mobile health interventions. J Med Internet Res 2011;13:e126.
8. Unni E, Gabriel S, Ariely R. A review of the use and effectiveness of digital health technologies in patients with asthma. Ann Allergy Asthma Immunol 2018;121:680–91.
9. MAGNIFY – Maximising Adherence and Gaining New Information for your COPD. Available from: https://opri.org.uk/magnify/ (accessed Sep 2020).
10. Costello RW, Dima AL, Ryan D et al. Effective deployment of technology-supported management of chronic respiratory conditions: a call for stakeholder engagement. Pragmatic and Observational Research 2017;8:119–28.