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

Our plain-English summary of Content validity and ePRO usability of the BPI-sf and "worst pain" item with pleural and peritoneal mesothelioma, by H.L. Gelhorn, S. Eremenco, A.M. Skalicky, et al (Journal of Patient-reported Outcomes, 2017).

The study

• Authors: H.L. Gelhorn, S. Eremenco, A.M. Skalicky, Z. Balantac, T. Cimms, K. Halling, C. Sexton
• Journal: Journal of Patient-reported Outcomes
• Published: 2017;2(1):16
• Cited by: 3 articles, as counted by NIH iCite
• Read it: PubMed · Publisher · Free full text

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.

In plain English

This qualitative interview study examined a pain questionnaire, not asbestos exposure. The authors interviewed 21 adults with mesothelioma from four US clinical sites between September 2013 and June 2014: 17 with pleural mesothelioma, three with peritoneal mesothelioma and one with both. They asked about pain and tested how patients understood the "worst pain" question of the Brief Pain Inventory short form (BPI-sf). Nine pleural participants also tried an electronic handheld version. Nine of the 21 described pain from their mesothelioma, in words ranging from "discomfort" to "intense". Participants could tell this pain apart from treatment pain. No one had trouble with the 24-hour recall period. Most device users found it easy to use, though one found the font too small and one did not understand the electronic body-diagram question. Most gave the same answers on paper and screen. The authors concluded that their findings support the questionnaire's content validity in pleural and peritoneal mesothelioma. As limitations, they noted that only patients with ECOG performance status 0 or 1 were included, few had peritoneal disease, and paper always came first.

We wrote this plain-English summary from the full article with the help of AI, and a second AI model checked each sentence against the article. It is not the authors' wording; the abstract and the article are their own account.

What the study did and found

• Design: Cross-sectional qualitative study using semi-structured interviews (concept elicitation and cognitive interviewing), with usability testing of an electronic version of the questionnaire
• Who was studied: 21 adults with mesothelioma recruited from 4 US clinical sites, interviewed in person (n = 9) or by telephone (n = 12) between September 2013 and June 2014. The group was 17 with pleural mesothelioma, 3 with peritoneal mesothelioma and 1 with both. 71% were male and the mean age was 68.7 years. All had ECOG performance status 0 or 1 and previous or current chemotherapy.
• Exposure: No asbestos exposure was studied. The study evaluated the Brief Pain Inventory short form (BPI-sf), especially its 'worst pain' item, on paper and on an electronic TrialMax Touch handheld device. The electronic version was tested in pleural mesothelioma participants interviewed in person.
• Main results:
  • 9 of 21 participants (43%) in the overall sample described pain resulting from their mesothelioma.
  • Participants described their pain with words ranging from 'discomfort' and 'twinge' to 'sharp' and 'intense'.
  • Participants could distinguish mesothelioma pain from treatment pain.
  • No participant had comprehension problems with the 24-hour recall period.
  • A majority of pleural participants and all peritoneal participants found the 'worst pain' item easy to answer.
  • Nine pleural participants (including the one with both pleural and peritoneal mesothelioma) took part in the electronic usability testing.
  • Nearly all of the nine usability participants reported positive impressions of the handheld device.
  • One usability participant had a negative impression of the electronic format because the font was too small to read easily. Three participants said a larger font would make the items easier to read.
  • One usability participant reported difficulty entering answers. This participant did not understand how to answer the body-diagram question on the electronic version and would have liked more explanation. Because it was not clear to him how to select more than one pain location on the device, his answer on this item differed from his paper answer. The authors recommended training on selecting multiple pain locations.
  • Most of the 9 usability participants gave the same answer on paper and on the device for each pain severity and pain impact question. For the 'worst pain' item, 6 gave the same response, 0 gave a different response, and 3 were not asked. One participant gave a different answer on the body-diagram item (item 2).
• The authors' conclusion: The authors concluded that their findings provide strong support for the content validity of the BPI-sf, on paper and in electronic format, in patients with pleural and peritoneal mesothelioma. They also concluded that the findings add to existing support for the 'worst pain' item as a key outcome measure in clinical trials with pleural mesothelioma patients.
• Limitations the authors state:
  • Only patients with ECOG performance status 0 or 1 were included. Whether the results apply to patients with more severe disease is unknown.
  • Pain was described less often than may be expected for this disease: by 44% of those with pleural mesothelioma and 50% of those with peritoneal mesothelioma.
  • Only a small number of participants with peritoneal mesothelioma were interviewed.
  • The paper version was always given before the electronic version, which may have introduced systematic bias.

Topics

Medical terms in this study, explained in our Lexicon: Peritoneal Mesothelioma, Clinical Trial, STEM, Pleural Mesothelioma.

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