A Randomized Study of Electronic Diary versus Paper and Pencil Collection of Patient-Reported Outcomes in Patients with Non-Small Cell Lung Cancer
- PMID: 22272807
- DOI: 10.2165/01312067-200801020-00006
A Randomized Study of Electronic Diary versus Paper and Pencil Collection of Patient-Reported Outcomes in Patients with Non-Small Cell Lung Cancer
Abstract
Background: Hand-held electronic devices may provide a simple reproducible means by which quality of life (QOL) may be documented in patients with cancer. However, the QOL scales that are routinely used were originally validated when used with paper and pencil data collection. Patient-reported outcomes acquired using hand-held electronic devices (electronic patient-reported outcomes [e-PRO]) may not be the same as those acquired using paper and pencil, so validation of this method of data collection is needed.
Objectives: This study aimed to compare the results of e-PRO and paper and pencil collection of Functional Assessment of Cancer Therapy-Lung (FACT-L) and EuroQol-5 Dimension (EQ-5D) QOL data in patients with advanced non-small cell lung cancer (NSCLC), and to ascertain patients' preferences for the different modes of collection.
Methods: This randomized, single-cohort, crossover study was performed in a tertiary referral hospital cancer center. Fifty patients with previously treated locally advanced or metastatic NSCLC were randomized in a 1 : 1 ratio to complete either paper versions of the questionnaires (FACT-L and EQ-5D) followed by the e-PRO versions, or the e-PRO questionnaire followed by the paper versions.
Results: The majority (88%) of the FACT-L and all (100%) of the EQ-5D individual question responses were within ±1 point of each other when data collection via e-PRO and via pencil and paper were compared. There was no significant difference between the mean total FACT-L scores obtained using the two methods; however, 29% of patients had a difference between FACT-L total scores obtained with the two methods that was greater than ±6 points. The mean completion time was shorter for the paper and pencil method than the e-PRO method (p < 0.0001). However, most patients stated that they preferred the e-PRO method over paper and pencil (60% vs 12%).
Conclusion: This study suggests that the mode of administration of the FACT-L and EQ-5D had a relatively small effect on the mean responses given to the questionnaires in patients with advanced NSCLC. However, at the individual patient level, data varied considerably between the different modes of administration. Therefore, the group results obtained using the e-PRO should be similar to the originally validated paper method, with the advantages of improved patient acceptability and ease of reliable interfacing with trial databases.
Similar articles
-
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 Mar-Apr;9(2):98-105. doi: 10.1111/j.1524-4733.2006.00087.x. Value Health. 2006. PMID: 16626413 Clinical Trial.
-
Analysis of patient-reported outcomes from the LUME-Lung 1 trial: a randomised, double-blind, placebo-controlled, Phase III study of second-line nintedanib in patients with advanced non-small cell lung cancer.Eur J Cancer. 2015 Feb;51(3):317-26. doi: 10.1016/j.ejca.2014.11.015. Epub 2014 Dec 17. Eur J Cancer. 2015. PMID: 25534294 Clinical Trial.
-
Electronic versus paper-pencil methods for assessing chemotherapy-induced peripheral neuropathy.Support Care Cancer. 2017 Nov;25(11):3437-3446. doi: 10.1007/s00520-017-3764-y. Epub 2017 Jun 2. Support Care Cancer. 2017. PMID: 28577231
-
Mapping the FACT-P to the preference-based EQ-5D questionnaire in metastatic castration-resistant prostate cancer.Value Health. 2014 Mar;17(2):238-44. doi: 10.1016/j.jval.2013.12.005. Value Health. 2014. PMID: 24636382 Clinical Trial.
-
Comparison of FACT- and EQ-5D-based utility scores in cancer.Value Health. 2012 Mar-Apr;15(2):305-11. doi: 10.1016/j.jval.2011.11.029. Epub 2012 Feb 2. Value Health. 2012. PMID: 22433762
Cited by
-
Applying Rasch analysis to evaluate measurement equivalence of different administration formats of the Activity Limitation scale of the Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR).Health Qual Life Outcomes. 2016 Apr 9;14:57. doi: 10.1186/s12955-016-0462-2. Health Qual Life Outcomes. 2016. PMID: 27062133 Free PMC article.
-
A comparison of brief versus explicit descriptors for verbal rating scales: interrupted time series design.Health Qual Life Outcomes. 2023 Sep 13;21(1):105. doi: 10.1186/s12955-023-02184-0. Health Qual Life Outcomes. 2023. PMID: 37705045 Free PMC article.
-
Equivalence of electronic and paper-based patient-reported outcome measures.Qual Life Res. 2015 Aug;24(8):1949-61. doi: 10.1007/s11136-015-0937-3. Epub 2015 Feb 22. Qual Life Res. 2015. PMID: 25702266 Review.
-
Choosing the right survey: the lung cancer surgery.J Thorac Dis. 2020 Nov;12(11):6892-6901. doi: 10.21037/jtd.2019.12.131. J Thorac Dis. 2020. PMID: 33282392 Free PMC article. Review.
-
Preferences for Use and Design of Electronic Patient-Reported Outcomes in Patients with Chronic Obstructive Pulmonary Disease.Patient. 2019 Dec;12(6):621-629. doi: 10.1007/s40271-019-00376-9. Patient. 2019. PMID: 31313271
References
LinkOut - more resources
Full Text Sources