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Software for Administering the National Cancer Institute's Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events: Usability Study.

Publication ,  Journal Article
Schoen, MW; Basch, E; Hudson, LL; Chung, AE; Mendoza, TR; Mitchell, SA; St Germain, D; Baumgartner, P; Sit, L; Rogak, LJ; Shouery, M ...
Published in: JMIR Hum Factors
July 16, 2018

BACKGROUND: The US National Cancer Institute (NCI) developed software to gather symptomatic adverse events directly from patients participating in clinical trials. The software administers surveys to patients using items from the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) through Web-based or automated telephone interfaces and facilitates the management of survey administration and the resultant data by professionals (clinicians and research associates). OBJECTIVE: The purpose of this study was to iteratively evaluate and improve the usability of the PRO-CTCAE software. METHODS: Heuristic evaluation of the software functionality was followed by semiscripted, think-aloud protocols in two consecutive rounds of usability testing among patients with cancer, clinicians, and research associates at 3 cancer centers. We conducted testing with patients both in clinics and at home (remotely) for both Web-based and telephone interfaces. Furthermore, we refined the software between rounds and retested. RESULTS: Heuristic evaluation identified deviations from the best practices across 10 standardized categories, which informed initial software improvement. Subsequently, we conducted user-based testing among 169 patients and 47 professionals. Software modifications between rounds addressed identified issues, including difficulty using radio buttons, absence of survey progress indicators, and login problems (for patients) as well as scheduling of patient surveys (for professionals). The initial System Usability Scale (SUS) score for the patient Web-based interface was 86 and 82 (P=.22) before and after modifications, respectively, whereas the task completion score was 4.47, which improved to 4.58 (P=.39) after modifications. Following modifications for professional users, the SUS scores improved from 71 to 75 (P=.47), and the mean task performance improved significantly (4.40 vs 4.02; P=.001). CONCLUSIONS: Software modifications, informed by rigorous assessment, rendered a usable system, which is currently used in multiple NCI-sponsored multicenter cancer clinical trials. TRIAL REGISTRATION: ClinicalTrials.gov NCT01031641; https://clinicaltrials.gov/ct2/show/NCT01031641 (Archived by WebCite at http://www.webcitation.org/708hTjlTl).

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Published In

JMIR Hum Factors

DOI

ISSN

2292-9495

Publication Date

July 16, 2018

Volume

5

Issue

3

Start / End Page

e10070

Location

Canada

Related Subject Headings

  • 4609 Information systems
  • 4203 Health services and systems
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Schoen, M. W., Basch, E., Hudson, L. L., Chung, A. E., Mendoza, T. R., Mitchell, S. A., … Abernethy, A. P. (2018). Software for Administering the National Cancer Institute's Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events: Usability Study. JMIR Hum Factors, 5(3), e10070. https://doi.org/10.2196/10070
Schoen, Martin W., Ethan Basch, Lori L. Hudson, Arlene E. Chung, Tito R. Mendoza, Sandra A. Mitchell, Diane St Germain, et al. “Software for Administering the National Cancer Institute's Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events: Usability Study.JMIR Hum Factors 5, no. 3 (July 16, 2018): e10070. https://doi.org/10.2196/10070.
Schoen MW, Basch E, Hudson LL, Chung AE, Mendoza TR, Mitchell SA, et al. Software for Administering the National Cancer Institute's Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events: Usability Study. JMIR Hum Factors. 2018 Jul 16;5(3):e10070.
Schoen, Martin W., et al. “Software for Administering the National Cancer Institute's Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events: Usability Study.JMIR Hum Factors, vol. 5, no. 3, July 2018, p. e10070. Pubmed, doi:10.2196/10070.
Schoen MW, Basch E, Hudson LL, Chung AE, Mendoza TR, Mitchell SA, St Germain D, Baumgartner P, Sit L, Rogak LJ, Shouery M, Shalley E, Reeve BB, Fawzy MR, Bhavsar NA, Cleeland C, Schrag D, Dueck AC, Abernethy AP. Software for Administering the National Cancer Institute's Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events: Usability Study. JMIR Hum Factors. 2018 Jul 16;5(3):e10070.

Published In

JMIR Hum Factors

DOI

ISSN

2292-9495

Publication Date

July 16, 2018

Volume

5

Issue

3

Start / End Page

e10070

Location

Canada

Related Subject Headings

  • 4609 Information systems
  • 4203 Health services and systems