Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2017;2(1):16.
doi: 10.1186/s41687-018-0039-4. Epub 2018 Mar 27.

Content validity and ePRO usability of the BPI-sf and "worst pain" item with pleural and peritoneal mesothelioma

Heather L Gelhorn  1 , Sonya Eremenco  1 , Anne M Skalicky  1 , Zaneta Balantac  1 , Tricia Cimms  2 , Katarina Halling  3 , Chris Sexton  1
Affiliations

Content validity and ePRO usability of the BPI-sf and "worst pain" item with pleural and peritoneal mesothelioma

Heather L Gelhorn et al. J Patient Rep Outcomes. 2017.

Abstract

Background: The Brief Pain Inventory-short form (BPI-sf) is widely used in self-reported pain assessment, incorporates pain numeric rating scales (NRS) and is commonly utilized in electronic format in clinical trials, however, there is no published information about its usability as an electronic patient-reported outcome (ePRO) measure. The objective of this qualitative study was threefold: 1) to better understand pain experiences among patients with pleural or peritoneal mesothelioma; 2) to assess the interpretability of the instructions, item stem, recall period, and response option of the "worst pain" item of the BPI-sf; and 3) to examine the usability of the TrialMax Touch™ (CRF Health, Inc., Plymouth Meeting, PA) screen-based handheld device and the electronic format of the BPI-sf in a sub-sample of pleural mesothelioma patients.

Methods: A cross-sectional qualitative study was conducted among participants with pleural and peritoneal mesothelioma recruited from 4 clinical sites in the US. Semi-structured telephone or in-person interviews were conducted consisting of concept elicitation, cognitive interviewing of the 11-item BPI-sf, and in-person interview evaluation of ePRO assessment usability in pleural mesothelioma patients.

Results: Twenty-one participants recruited from 4 clinical sites in the US were interviewed in-person (n = 9) and by telephone (n = 12); 71% male; mean age 68.7 ± 13.6 years. Pleural and peritoneal patients described pain as ranging from discomfort to intense pain and reported being able to distinguish tumor pain from treatment pain. The BPI-sf "worst pain" item was relevant to, and easily understood by, study participants with pleural and peritoneal mesothelioma. The ePRO version was found to be easy to use, but readability of small font may be an issue. Participants reported minimal differences between their responses on the paper and ePRO version for all of the pain severity and pain interference items.

Conclusions: Results support the relevance and ease of understanding of the "worst pain" item and provide support for its content validity in patients with pleural and peritoneal mesothelioma. Usability of the ePRO format of the BPI-sf was confirmed for use in clinical trials among patients with pleural mesothelioma.

Keywords: Brief pain inventory; HRQL; Mesothelioma; Pain; Patient reported outcome; Qualitative; Symptoms.

PubMed Disclaimer

Conflict of interest statement

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. This study was approved by MD Anderson 2013–0913; Roswll Park Cancer Institute 239,113; Scott & White 130,030; Moffitt Cancer Center 17,444.Not applicable.Dr. Halling is currently employed and Ms. Cimms formerly employed by AstraZeneca. Dr. Gelhorn, Ms. Skalicky, and Ms. Balantac are current salaried employees and Dr. Sexton and Ms. Eremenco are former employees of Evidera, a consulting company, which has received funding from AZ for conducting the study. They are precluded from receiving payment/honoraria directly from companies for which Evidera consults. The authors have no other relevant affiliations or financial involvement with any organization or entity with financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

References

    1. van Meerbeeck JP, Scherpereel A, Surmont VF, Baas P. Malignant pleural mesothelioma: The standard of care and challenges for future management. Crit Rev Oncol Hematol. 2011;78(2):92–111. doi: 10.1016/j.critrevonc.2010.04.004. - DOI - PubMed
    1. Lanphear BP, Buncher CR. Latent period for malignant mesothelioma of occupational origin. Journal of occupational medicine: official publication of the Industrial Medical Association. 1992;34(7):718–721. - PubMed
    1. Selikoff IJ, Hammond EC, Seidman H. Latency of asbestos disease among insulation workers in the United States and Canada. Cancer. 1980;46(12):2736–2740. doi: 10.1002/1097-0142(19801215)46:12<2736::AID-CNCR2820461233>3.0.CO;2-L. - DOI - PubMed
    1. Larson T, Melnikova N, Davis SI, Jamison P. Incidence and descriptive epidemiology of mesothelioma in the United States, 1999-2002. Int J Occup Environ Health. 2007;13(4):398–403. doi: 10.1179/oeh.2007.13.4.398. - DOI - PubMed
    1. Park EK, Takahashi K, Hoshuyama T, Cheng TJ, Delgermaa V, Le GV, Sorahan T. Global magnitude of reported and unreported mesothelioma. Environ Health Perspect. 2011;119(4):514–518. doi: 10.1289/ehp.1002845. - DOI - PMC - PubMed

LinkOut - more resources