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      Comparability of a provisioned device versus bring your own device for completion of patient-reported outcome measures by participants with chronic obstructive pulmonary disease: qualitative interview findings

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          Abstract

          Background

          There is interest in participants using their own smartphones or tablets (“bring your own device”; BYOD) to complete patient-reported outcome (PRO) measures in clinical studies. Our study aimed to qualitatively evaluate participants’ experience using a provisioned device (PD) versus their own smartphone (BYOD) for this purpose.

          Methods

          Participants with chronic obstructive pulmonary disease (COPD) were recruited for this observational, cross-over study and completed PRO measures daily on one device type for 15 days, then switched to the other device type to complete the same measures for another 15 days. After each 15-day period, semi-structured interviews were conducted about their experience with the device.

          Results

          Of 64 participants enrolled, the final qualitative analysis populations comprised those who participated in an interview without protocol violations. Thus, the qualitative longitudinal population (LP) included n = 57 (89%), while the qualitative cross-sectional population (CSP) included n = 60 (94%). CSP participants found both device types easy to use. Twenty CSP participants (33%) reported missing data entry on at least one day when using PD, and 24 (40%) reported missing at least one day when using BYOD. In the LP, preference for one of the device types was somewhat evenly split; 45.6% (n = 26) preferred PD and 50.9% (n = 29) preferred BYOD. The most common reason for preferring PD was that it was “dedicated” to the study; the “convenience” of carrying a single device was the main reason for preferring BYOD.

          Conclusion

          The findings from the interviews demonstrated few differences in participants’ experience completing PRO measures on a PD versus BYOD. Our study supports the use of BYOD as a potential addition to PD for collecting PRO data and contributes evidence that BYOD may be employed to collect PRO data in demographically diverse patient populations.

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          Utilizing a Personal Smartphone Custom App to Assess the Patient Health Questionnaire-9 (PHQ-9) Depressive Symptoms in Patients With Major Depressive Disorder

          John Torous, Patrick Staples, Meghan Shanahan … (2015)
          Background Accurate reporting of patient symptoms is critical for diagnosis and therapeutic monitoring in psychiatry. Smartphones offer an accessible, low-cost means to collect patient symptoms in real time and aid in care. Objective To investigate adherence among psychiatric outpatients diagnosed with major depressive disorder in utilizing their personal smartphones to run a custom app to monitor Patient Health Questionnaire-9 (PHQ-9) depression symptoms, as well as to examine the correlation of these scores to traditionally administered (paper-and-pencil) PHQ-9 scores. Methods A total of 13 patients with major depressive disorder, referred by their clinicians, received standard outpatient treatment and, in addition, utilized their personal smartphones to run the study app to monitor their symptoms. Subjects downloaded and used the Mindful Moods app on their personal smartphone to complete up to three survey sessions per day, during which a randomized subset of PHQ-9 symptoms of major depressive disorder were assessed on a Likert scale. The study lasted 29 or 30 days without additional follow-up. Outcome measures included adherence, measured by the percentage of completed survey sessions, and estimates of daily PHQ-9 scores collected from the smartphone app, as well as from the traditionally administered PHQ-9. Results Overall adherence was 77.78% (903/1161) and varied with time of day. PHQ-9 estimates collected from the app strongly correlated (r=.84) with traditionally administered PHQ-9 scores, but app-collected scores were 3.02 (SD 2.25) points higher on average. More subjects reported suicidal ideation using the app than they did on the traditionally administered PHQ-9. Conclusions Patients with major depressive disorder are able to utilize an app on their personal smartphones to self-assess their symptoms of major depressive disorder with high levels of adherence. These app-collected results correlate with the traditionally administered PHQ-9. Scores recorded from the app may potentially be more sensitive and better able to capture suicidality than the traditional PHQ-9.
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            Recommendations on evidence needed to support measurement equivalence between electronic and paper-based patient-reported outcome (PRO) measures: ISPOR ePRO Good Research Practices Task Force report.

            Stephen Coons, Chad J Gwaltney, Ron D Hays … (2009)
            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, biological 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 end points 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. The task force was composed of the leadership team of ISPOR's ePRO Working Group and members of another group (i.e., ePRO Consensus Development Working Group) that had already begun to develop recommendations regarding ePRO good research practices. The resulting task force membership reflected a broad array of backgrounds, perspectives, and expertise that enriched the development of this report. The prior work became the starting point for the Task Force report. A subset of the task force members became the writing team that prepared subsequent iterations of the report that were distributed to the full task force for review and feedback. In addition, review beyond the task force was sought and obtained. Along with a presentation and discussion period at an ISPOR meeting, a draft version of the full report was distributed to roughly 220 members of a reviewer group. The reviewer group comprised individuals who had responded to an emailed invitation to the full membership of ISPOR. This Task Force report reflects the extensive internal and external input received during the 16-month good research practices development process. RESULTS/RECOMMENDATIONS: An ePRO questionnaire that has been adapted from a paper-based questionnaire ought to produce data that are equivalent or superior (e.g., higher reliability) to the data produced from the original paper version. Measurement equivalence is a function of the comparability of the psychometric properties of the data obtained via the original and adapted administration mode. This comparability is driven by the amount of modification to the content and format of the original paper PRO questionnaire required during the migration process. The magnitude of a particular modification is defined with reference to its potential effect on the content, meaning, or interpretation of the measure's items and/or scales. Based on the magnitude of the modification, evidence for measurement equivalence can be generated through combinations of the following: cognitive debriefing/testing, usability testing, equivalence testing, or, if substantial modifications have been made, full psychometric testing. As long as only minor modifications were made to the measure during the migration process, a substantial body of existing evidence suggests that the psychometric properties of the original measure will still hold for the ePRO version. Hence, an evaluation limited to cognitive debriefing and usability testing only may be sufficient. However, where more substantive changes in the migration process has occurred, confirming that the adaptation to the ePRO format did not introduce significant response bias and that the two modes of administration produce essentially equivalent results is necessary. Recommendations regarding the study designs and statistical approaches for assessing measurement equivalence are provided. The electronic administration of PRO measures offers many advantages over paper administration. We provide a general framework for decisions regarding the level of evidence needed to support modifications that are made to PRO measures when they are migrated from paper to ePRO devices. The key issues include: 1) the determination of the extent of modification required to administer the PRO on the ePRO device and 2) the selection and implementation of an effective strategy for testing the measurement equivalence of the two modes of administration. We hope that these good research practice recommendations provide a path forward for researchers interested in migrating PRO measures to electronic data collection platforms.
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              Capturing Patient-Reported Outcome (PRO) Data Electronically: The Past, Present, and Promise of ePRO Measurement in Clinical Trials

              Stephen Coons, Sonya Eremenco, J. Jason Lundy … (2014)
              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 paper-based 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 device-based 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.
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                Author and article information

                Contributors
                Louise Newton:
                ORCID: http://orcid.org/0000-0003-3036-2021
                louise.newton@clinoutsolutions.com
                Journal
                Journal ID (nlm-ta): J Patient Rep Outcomes
                Journal ID (iso-abbrev): J Patient Rep Outcomes
                Title: Journal of Patient-Reported Outcomes
                Publisher: Springer International Publishing (Cham )
                ISSN (Electronic): 2509-8020
                Publication date (Electronic): 4 August 2022
                Publication date PMC-release: 4 August 2022
                Publication date Collection: December 2022
                Volume: 6
                Electronic Location Identifier: 86
                Affiliations
                [1 ]Clinical Outcomes Solutions, Folkestone, UK
                [2 ]Broughton Life Sciences, Earby, UK
                [3 ]GRID grid.417621.7, Critical Path Institute, ; Tucson, USA
                [4 ]Clinical Outcomes Solutions, Tucson, USA
                [5 ]GRID grid.134563.6, ISNI 0000 0001 2168 186X, College of Public Health, , University of Arizona, ; Tucson, AZ USA
                [6 ]Imbria Pharmaceuticals, Boston, MA USA
                [7 ]Signant Health, London, UK
                [8 ]Medidata Solutions, London, UK
                [9 ]GRID grid.418424.f, ISNI 0000 0004 0439 2056, Novartis Pharmaceuticals, ; East Hanover, NJ USA
                Author information
                http://orcid.org/0000-0003-3036-2021
                Article
                Publisher ID: 492
                DOI: 10.1186/s41687-022-00492-5
                PMC ID: 9352826
                PubMed ID: 35925498
                SO-VID: 9409d189-c69a-423f-b90e-3aed97099f1f
                Copyright © © The Author(s) 2022
                License:

                Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.

                History
                Date received : 12 April 2022
                Date accepted : 24 July 2022
                Funding
                Funded by: Critical Path Institute's Patient-Reported Outcome (PRO) Consortium and Electronic Outcome Assessment (eCOA) Consortium
                Funded by: Additional contributions were made from the following PRO Consortium member firms: Amgen Inc.; Bayer Pharma AG; Daiichi Sankyo, Inc.; GlaxoSmithKline; Ironwood Pharmaceuticals, Inc.; Janssen Pharmaceutical Companies of Johnson and Johnson; Eli Lilly and Co
                Categories
                Subject: Research
                Custom metadata
                issue-copyright-statement © The Author(s) 2022

                Keywords: byod,epro,pro measure,bring your own device,patient-reported outcome,provisioned device,qualitative,equivalence,comparability
                Data availability:
                Keywords: byod, epro, pro measure, bring your own device, patient-reported outcome, provisioned device, qualitative, equivalence, comparability

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