Content validity and electronic PRO (ePRO) usability of the Lung Cancer Symptom Scale-Mesothelioma (LCSS-Meso) in mesothelioma patients

Our plain-English summary of Content validity and electronic PRO (ePRO) usability of the Lung Cancer Symptom Scale-Mesothelioma (LCSS-Meso) in mesothelioma patients, by H.L. Gelhorn, A.M. Skalicky, Z. Balantac, et al (Supportive Care in Cancer, 2018).

The study

• Authors: H.L. Gelhorn, A.M. Skalicky, Z. Balantac, S. Eremenco, T. Cimms, K. Halling, P.J. Hollen, R.J. Gralla, M.C. Mahoney, C. Sexton
• Journal: Supportive Care in Cancer
• Published: 2018;26(7):2229-2238
• Cited by: 6 articles, as counted by NIH iCite
• Read it: PubMed · Publisher

Abstract

Purpose: Obtaining qualitative data directly from the patient perspective enhances the content validity of patient-reported outcome (PRO) instruments. The objective of this qualitative study was to evaluate the content validity of the Lung Cancer Symptom Scale for Mesothelioma (LCSS-Meso) and its usability on an electronic device.

Methods: A cross-sectional methodological study, using a qualitative approach, was conducted among patients recruited from four clinical sites. The primary target population included patients with pleural mesothelioma; data were also collected from patients with peritoneal mesothelioma on an exploratory basis. Semi-structured interviews were conducted consisting of concept elicitation, cognitive interviewing, and evaluation of electronic patient-reported outcome (ePRO) usability.

Results: Participants (n = 21) were interviewed in person (n = 9) or by telephone (n = 12); 71% were male with a mean age of 69 years (SD = 14). The most common signs and symptoms experienced by participants with pleural mesothelioma (n = 18) were shortness of breath, fluid build-up, pain, fatigue, coughing, and appetite loss. The most commonly described symptoms for those with peritoneal mesothelioma (n = 4) were bloating, changes in appetite, fatigue, fluid build-up, shortness of breath, and pain. Participants with pleural mesothelioma commonly described symptoms assessed by the LCSS-Meso in language consistent with the questionnaire and a majority understood and easily completed each of the items. The ePRO version was easy to use, and there was no evidence that the electronic formatting changed the way participants responded to the questions.

Conclusions: Results support the content validity of the LCSS-Meso and the usability of the electronic format for use in assessing symptoms among patients with pleural mesothelioma.

In plain English

This study tested whether a symptom questionnaire, the Lung Cancer Symptom Scale for Mesothelioma (LCSS-Meso), reflects what patients describe and works electronically. It did not study asbestos exposure. The authors interviewed 21 patients at four US clinical sites: 17 with pleural mesothelioma, three with peritoneal mesothelioma and one with both. Among the 18 with pleural disease, the most reported signs and symptoms were shortness of breath (16), fluid build-up (14), coughing (12) and fatigue (11). The article classes fluid build-up as a sign, not a symptom. Among the 4 with peritoneal disease, appetite changes, fatigue and bloating were each reported by 3, and none reported cough even when asked. Peritoneal patients found some items less relevant. Eight of nine pleural patients who tried the electronic version gave positive impressions, though some had trouble marking answers on the touch screen. The authors concluded the results support the questionnaire, on paper and electronically, for pleural mesothelioma. They wrote that their findings suggest it is not suitable for peritoneal mesothelioma. They noted the sample was small, highly selected, and from the USA only.

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 methodological study using semi-structured interviews (symptom description, cognitive interviewing about the questionnaire, and usability testing of an electronic version)
• Who was studied: 21 adults with mesothelioma recruited from four clinical sites in the USA (Florida, New York, and two in Texas), interviewed between 11 September 2013 and 19 June 2014. 17 had pleural mesothelioma, three had peritoneal mesothelioma and one had both, giving 18 pleural and 4 peritoneal in the analyses. Mean age was 68.7 years, and 71% were male.
• Exposure: No asbestos exposure was studied. The study examined the LCSS-Meso, an eight-item symptom questionnaire developed for pleural mesothelioma. All participants completed it on paper, and a subgroup of 9 pleural participants also used an electronic touch-screen diary.
• Main results:
  • Pleural mesothelioma participants reported shortness of breath (16/18), fluid build-up (14/18), coughing (12/18), fatigue (11/18), pain (8/18), weight loss (6/18) and appetite changes (5/18).
  • The article classes fluid build-up and weight loss as signs rather than symptoms, and the questionnaire does not capture them.
  • Peritoneal mesothelioma participants reported appetite changes (3/4), fatigue (3/4), bloating (3/4), pain (2/4), swelling (2/4), fluid build-up (2/4) and weight loss (2/4).
  • Peritoneal participants did not report cough, even when asked about it directly.
  • Of 15 pleural participants who gave overall impressions of the questionnaire, 11 appraised it favorably.
  • 6 of 18 pleural participants named impacts the questionnaire does not cover: psychological functioning (for example depression), sleep disturbances and stressed relationships.
  • Peritoneal participants found some questionnaire items less relevant to their experience.
  • Of 9 pleural participants who used the electronic version, 8 reported positive impressions. The other 1 had a negative impression, saying the font was too small.
  • Some participants had difficulty marking their answer in the exact place on the touch-screen scale. The authors found no evidence that the electronic format changed how participants responded.
  • The authors stated that their findings suggest the LCSS-Meso is not suitable for patients with peritoneal mesothelioma.
• The authors' conclusion: The authors concluded that the results support the content validity of the LCSS-Meso, and the usability of its electronic format, for assessing symptoms in patients with pleural mesothelioma.
• Limitations the authors state:
  • Only patients with good performance status (ECOG 0 or 1) were included. Patients with more severe, active disease were not.
  • Participants were selected with criteria similar to clinical trial eligibility, which made the sample highly selected and limited its generalizability.
  • Telephone interviews may have been less effective for training participants on how to complete the questionnaire.
  • Only participants from the USA took part.
  • Because the peritoneal sample was small, saturation of symptom concepts was not reached for that group.
  • The small overall sample size may limit the conclusions.

Topics

The National Library of Medicine indexes this study under subjects our site covers: Lung cancer, Mesothelioma.

Medical terms in this study, explained in our Lexicon: Lung Cancer, Mesothelioma, Pleural Mesothelioma, Peritoneal Mesothelioma.

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