Preferences for Use and Design of Electronic Patient-Reported Outcomes in Patients with Chronic Obstructive Pulmonary Disease
Collection of patient-reported outcome (PRO) measures is critical to fully understand chronic obstructive pulmonary disease (COPD) management and progression, as the impact on health-related quality of life is not well understood by objective measures alone. Electronic PROs (ePROs) are increasingly used because of their advantages over paper data collection, including elimination of transcription errors, increased accuracy and data quality, real-time data reporting, and increased compliance. The objective of this study was to characterize how patients with COPD prefer to use various types of technology to report disease symptoms, and their preferences for ePRO design and display.
The sample consisted of subjects with COPD (N = 103) who completed in-person surveys on their ePRO preferences.
The majority of subjects prefer to use a form of electronic media over paper to report their disease symptoms. Of these electronic methods, subjects most often prefer to use a smartphone provided by their physician. Subjects were also interested in ePRO features, such as knowing estimated PRO completion time at the outset, tracking their progress in real time as they complete a questionnaire, seeing the data that they report in order to track their health status, being encouraged to complete their diary if they fall behind by positive messaging, and being thanked for their completion of a daily diary.
Investigators should consider including these preferences when designing ePRO assessments. Incorporating patient preferences for ePRO design can ultimately help reduce patient burden and increase engagement, compliance, and improve data quality.
This work was supported by eResearch Technology (ERT). The authors would like to acknowledge the subjects who participated in the study.
Author KMD analyzed the data and wrote the manuscript. Authors ND, LK, and ST contributed to data analysis. Authors BW and CJE performed participant interviews and edited the manuscript. Author SMD contributed to study design and edited the manuscript.
Compliance with Ethical Standards
All procedures performed involving human participants were in accordance with the ethical standards of the national research committee (Copernicus Group IRB) and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. Informed consent was obtained from all individual participants included in the study.
This study was funded by eResearch Technology (ERT).
Conflict of Interest
Authors KMD, ND, LK, STG, and SMD are employees of eResearch Technology (ERT), which funded this research, and authors CE and BW are employees of Endpoint Outcomes, which performs services for ERT.
- 1.Burden of COPD. In: World Health Organization: chronic respiratory diseases: chronic obstructive pulmonary disease (COPD). http://www.who.int/respiratory/copd/burden/en/index.html. Accessed 15 May 2019.
- 2.Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global strategy for the diagnosis, management, and prevention of COPD. 2019. https://goldcopd.org/gold-reports/. Accessed 15 May 2019.
- 5.Chronic obstructive pulmonary disease: use of the St. George’s Respiratory Questionnaire as a PRO assessment tool: guidance for industry. 2018. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/chronic-obstructive-pulmonary-disease-use-st-georges-respiratory-questionnaire-pro-assessment-tool. Accessed 15 May 2019.
- 8.Shah SA, Velardo C, Gibson OJ, Rutter H, Farmer A, Tarassenko L. Personalized alerts for patients with COPD using pulse oximetry and symptom scores. Conf Proc IEEE Eng Med Biol Soc. 2014;2014:3164–7.Google Scholar
- 9.Kulich K, Keininger DL, Tiplady B, Banerji D. Symptoms and impact of COPD assessed by an electronic diary in patients with moderate-to-severe COPD: psychometric results from the SHINE study. Int J Chron Obstruct Pulmon Dis. 2015;10:79–94.Google Scholar
- 15.Patient-reported outcome measures: use in medical product development to support labeling claims: guidance for industry. 2009. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/patient-reported-outcome-measures-use-medical-product-development-support-labeling-claims. Accessed 15 May 2019.
- 16.Reflection paper on the regulatory guidance for the use of health-related quality of life (HRQL) measures in the evaluation of medicinal products. European Medicines Agency; 2005. Doc. Ref. EMEA/CHMP/EWP/139391/2004.Google Scholar
- 18.Coons SJ, Gwaltney CJ, Hays RD, Lundy JJ, Sloan JA, Revicki DA, et al. 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. Value Health. 2009;12(4):419–29.CrossRefGoogle Scholar
- 19.CDER patient-focused drug development. 2018. https://www.fda.gov/drugs/development-approval-process-drugs/cder-patient-focused-drug-development. Accessed 28 June 2019.
- 23.Jose N, Langel K. ePRO vs. paper. Appl Clin Trials Online. 2010. http://www.appliedclinicaltrialsonline.com/epro-vs-paper. Accessed 15 May 2019.
- 29.Bushnell DM, Reilly MC, Galani C, Martin ML, Ricci JF, Patrick DL, et al. Validation of electronic data capture of the irritable bowel syndrome-quality of life measure, the work productivity and activity impairment questionnaire for irritable bowel syndrome and the EuroQol. Value Health. 2006;9(2):98–105.CrossRefGoogle Scholar
- 30.Araujo L, Jacinto T, Moreira A, Castel-Branco MG, Delgado L, Costa-Pereira A, et al. Clinical efficacy of web-based versus standard asthma self-management. J Investig Allergol Clin Immunol. 2012;22(1):28–34.Google Scholar
- 31.Gwaltney C, Coons SJ, O’Donohoe P, O’Gorman H, Denomey M, Howry C, et al. “Bring Your Own Device” (BYOD): the future of field-based patient-reported outcome data collection in clinical trials? Ther Innov Regul Sci. 2015;49(6):783–91.Google Scholar