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Patient adherence and response time in electronic patient-reported outcomes: insights from three longitudinal clinical trials

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Abstract

Purpose

Patient-reported outcome measures (PROMs) are used to collect data on disease symptoms in support of clinical trial endpoints. Clinical studies can last a year or more, and the patients’ adherence and response time to daily at-home questionnaires may vary significantly over time. The aim of this study was to understand patterns and changes in patients’ completion of daily PROMs during longitudinal clinical studies.

Methods

Data were collected from 1342 patients randomized into three respiratory clinical trials (NCT03401229, NCT03347279, and NCT03406078). PROMs were completed by patients using electronic handheld devices that collected the starting and completion times. A Bayesian generalized linear mixed-effects model was used to identify unbiased coefficients associated with PROM adherence and response time using patient, site, and calendar features as covariates.

Results

Adherence decreased over time after randomization, and the rate of decrease was higher in younger patients. The 14-day pre-randomization adherence was correlated with adherence throughout the study. Patients were also more adherent during working days compared to non-working days. Oldest patients took twice as long to complete PROMs throughout the study; however, the response time for all patients decreased during the first month of the study regardless of age. Response time increased 7 days before and after the date of a scheduled clinic visit and when a patient-reported higher symptom burden.

Conclusion

Detailed analyses of adherence and response time for daily PROMs in clinical trials can provide significant insights about trends of patient behavior in longitudinal clinical studies with high baseline adherence.

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Data availability

Data underlying the findings described in this manuscript may be obtained in accordance with AstraZeneca’s data sharing policy described at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Data for studies directly listed on Vivli can be requested through Vivli at www.vivli.org. Data for studies not listed on Vivli could be requested through Vivli at https://vivli.org/members/enquiries-about-studies-not-listed-on-the-vivli-platform/. AstraZeneca Vivli member page is also available outlining further details: https://vivli.org/ourmember/astrazeneca/.

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Acknowledgements

We are grateful to Romina Dennehy and Davorin Miletic of Clario (formerly ERT) for providing us the timestamped ePROM data on an ad hoc basis. We also appreciate Sean O’Quinn, William Dott, and Olga Elizarova of AstraZeneca as well as Priyanka Sen for proofreading and commenting on the manuscript.

Funding

AstraZeneca sponsored the clinical studies and also funded this work.

Author information

Authors and Affiliations

  1. Imaging & Data Analytics, Clinical Pharmacology & Safety Sciences, AstraZeneca, R&D BioPharmaceuticals, Cambridge, UK

    Andrzej Nowojewski & Richard Dearden

  2. BioPharmaceuticals Medical, AstraZeneca, Gothenburg, Sweden

    Erik Bark

  3. BioPharmaceuticals Medical, AstraZeneca, Gaithersburg, MD, USA

    Vivian H. Shih

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  1. Andrzej Nowojewski
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Contributions

AN, EB, VHS, and RD designed and directed the project. EB and VHS obtained the datasets. AN designed and executed the analysis. EB and VHS validated the results. AN wrote the manuscript with critical review and input from all authors. The final manuscript was reviewed and approved for submission by all authors.

Corresponding author

Correspondence to Andrzej Nowojewski.

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Competing interest

All authors are or were employees and shareholders of AstraZeneca at the time of study conduct.

Ethical approval

The details of the design and results of the OSTRO, NAVIGATOR, and SOURCE trials have been previously reported (ClinicalTrials.gov Identifiers: NCT03401229 [22], NCT03347279 [23], and NCT03406078 [24]). The protocols were approved by the independent ethics committee at each participating site, and all patients provided written informed consent. A review process was followed that ensured that the proposed analysis was within the scope of original approvals and signed informed consent forms (INT-20211208–893, 8 December 2021). This study used existing fully de-identified data and the investigators or patients could not be identified, directly or through identifiers linked to patients.

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Nowojewski, A., Bark, E., Shih, V.H. et al. Patient adherence and response time in electronic patient-reported outcomes: insights from three longitudinal clinical trials. Qual Life Res (2024). https://doi.org/10.1007/s11136-024-03644-w

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