ePRO: Enhancing Patient Compliance and Product Safety

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CRF Health

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ePRO: Enhancing Patient Compliance and Product Safety

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About half of all adults in the US—117 million people—have one or more chronic health conditions, and the number is on the rise.1 In order to address this growing challenge, the Care Beyond Walls and Wires (CBWW) program was created to increase access to care and improve outcomes for patients suffering from chronic disease. A collaboration between Qualcomm® Wireless Reach™, Northern Arizona Healthcare (NAH), Qualcomm Life, Inc., and Entra Health Systems, CBWW began as a congestive heart failure remote monitoring program. Started in 2011, CBWW utilizes 3G/4G mobile broadband with connected home-use medical devices to enable nursing care coordinators to remotely monitor patients. As of 2017 the program is expanding to cover more patients with other chronic or high-risk conditions such as sepsis (blood poisoning from infection). The program aims to extend the delivery of care beyond the walls of hospitals by giving patients the tools to stay connected to providers – anytime, anywhere.

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Patient-reported outcomes (PROs) are an important means of evaluating the treatment benefit of new medical products. It is recognized that PRO measures should be used when assessing concepts best known by the patient or best measured from the patient’s perspective. As a result, there is growing emphasis on well defined and reliable PRO measures. In addition, advances in technology have significantly increased electronic PRO (ePRO) data collection capabilities and options in clinical trials. The movement from paperbased to ePRO data capture has enhanced the integrity and accuracy of clinical trial data and is encouraged by regulators. A primary distinction in the types of ePRO platforms is between telephone-based interactive voice response systems and screen-based systems. Handheld touchscreen-based devices have become the mainstay for remote (i.e., off-site, unsupervised) PRO data collection in clinical trials. The conventional approach is to provide study subjects with a handheld device with a devicebased proprietary software program. However, an emerging alternative for clinical trials is called bring your own device (BYOD). Leveraging study subjects’ own Internet-enabled mobile devices for remote PRO data collection (via a downloadable app or a Web-based data collection portal) has become possible due to the widespread use of personal smartphones and tablets. However, there are a number of scientific and operational issues that must be addressed before BYOD can be routinely considered as a practical alternative to conventional ePRO data collection methods. Nevertheless, the future for ePRO data collection is bright and the promise of BYOD opens a new chapter in its evolution.

Capturing Patient-Reported Outcome (PRO) Data Electronically: The Past, Prese...

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Objective To conduct a systematic review and meta-analysis of the equivalence between electronic and paper administration of patient reported outcome measures (PROMs) in studies conducted subsequent to those included in Gwaltney et al’s 2008 review. Methods A systematic literature review of PROM equivalence studies conducted between 2007 and 2013 identified 1,997 records from which 72 studies met pre-defined inclusion/exclusion criteria. PRO data from each study were extracted, in terms of both correlation coefficients (ICCs, Spearman and Pearson correlations, Kappa statistics) and mean differences (standardized by the standard deviation, SD, and the response scale range). Pooled estimates of correlation and mean difference were estimated. The modifying effects of mode of administration, year of publication, study design, time interval between administrations, mean age of participants and publication type were examined.

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Patient-reported outcomes (PROs) are the consequences of disease and/or its treatment as reported by the patient. The importance of PRO measures in clinical trials for new drugs, biologic agents, and devices was underscored by the release of the US Food and Drug Administration’s draft guidance for industry titled "Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims." The intent of the guidance was to describe how the FDA will evaluate the appropriateness and adequacy of PRO measures used as effectiveness endpoints in clinical trials. In response to the expressed need of ISPOR members for further clarification of several aspects of the draft guidance, ISPOR’s Health Science Policy Council created three task forces, one of which was charged with addressing the implications of the draft guidance for the collection of PRO data using electronic data capture modes of administration (ePRO). The objective of this report is to present recommendations from ISPOR’s ePRO Good Research Practices Task Force regarding the evidence necessary to support the comparability, or measurement equivalence, of ePROs to the paper-based PRO measures from which they were adapted.

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This guidance provides recommendations to sponsors, Contract Research Organizations (CROs), clinical investigators, and others involved in the capture, review, and retention of electronic source data in FDA-regulated clinical investigations.2 In an effort to streamline and modernize clinical investigations this guidance promotes capturing source data in electronic form, and it is intended to assist in ensuring the reliability, quality, integrity, and traceability of data from electronic source to electronic regulatory submission.

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