Evaluation of the psychometric properties and minimally important difference of the MD Anderson Symptom Inventory for malignant pleural mesothelioma (MDASI-MPM)

Our plain-English summary of Evaluation of the psychometric properties and minimally important difference of the MD Anderson Symptom Inventory for malignant pleural mesothelioma (MDASI-MPM), by T.R. Mendoza, L.A. Williams, K.N. Keating, et al (Journal of Patient-reported Outcomes, 2019).

The study

• Authors: T.R. Mendoza, L.A. Williams, K.N. Keating, J. Siegel, C. Elbi, A.K. Nowak, R. Hassan, B. Cuffel, C.S. Cleeland
• Journal: Journal of Patient-reported Outcomes
• Published: 2019;3(1):34
• Cited by: 10 articles, as counted by NIH iCite
• Read it: PubMed · Publisher · Free full text

Abstract

Background: Symptom assessment requires psychometrically validated questionnaires that are easy to use, relevant to the disease, and quick to administer. The MD Anderson Symptom Inventory for malignant pleural mesothelioma (MDASI-MPM) was adapted from the general (core) MDASI to assess the severity of cancer-related and treatment-related symptoms specific to patients with this condition. The MDASI-MPM includes the 13 core MDASI symptoms, which are experienced by most cancer patients, and 6 MPM-specific items developed via qualitative interviewing, a method favored by the US Food and Drug Administration for instrument item generation and development. Qualitative interviewing that summarizes the item generation and development for the MDASI-MPM is detailed in a separate report. The psychometric study reported here was the next step in developing the validation dossier for the MDASI-MPM.

Results: In this secondary analysis of data from a Phase II trial, 248 patients provided MDASI-MPM data at multiple timepoints during therapy. Over time, fatigue, pain, shortness of breath, feeling of malaise, and muscle weakness were consistently the worst symptoms reported; symptoms interfered most with work and general activity and least with relations with others. Cronbach coefficient alpha values for all MDASI-MPM subscales were at least 0.88 at baseline and 0.91 during treatment, indicating good internal consistency reliability. Intraclass correlations of at least 0.86 for all MDASI-MPM subscales administered a cycle apart (n = 82) were indicative of good test-retest reliability. Correlations between MDASI-MPM subscales and LCSS-Meso scores were at least 0.70 (P < 0.001 for all comparisons). Patients with good performance status had significantly lower scores than did patients with poor performance status (all P < 0.05), supporting evidence for known-group validity and sensitivity. Effect-size differences were 0.69 and higher, indicating medium-to-large effects. The minimally important difference in the MDASI-MPM subscales ranged from 1.0 to 1.5 points on a 0-10 scale.

Conclusions: Symptoms specific to a particular cancer, treatment method, or treatment site can be added to the core MDASI to create a tailored, "fit for purpose" instrument. We found the MDASI-MPM to be a valid, reliable, and responsive (sensitive) instrument for assessing the severity of symptoms of patients with MPM and their interference in patients' daily functioning.

In plain English

This study tested a symptom questionnaire, the MD Anderson Symptom Inventory for malignant pleural mesothelioma (MDASI-MPM). It adds 6 mesothelioma-specific items to 13 general cancer symptoms and asks about interference with daily life. The authors reanalyzed data from 248 patients with advanced or metastatic malignant pleural mesothelioma in a Phase II drug trial. These patients answered the questionnaire repeatedly during second-line treatment. The study did not examine asbestos exposure. At baseline, 47% of patients rated fatigue moderate to severe. The questionnaire's items gave consistent results. Among 82 patients with relatively stable quality-of-life ratings, scores were similar when repeated one treatment cycle apart. Scores correlated above 0.70 with another mesothelioma questionnaire, the LCSS-Meso. Through Cycle 3 Day 1, fully active patients scored lower than less active patients. Among 50 patients whose performance status worsened, average symptom scores rose from 2.2 to 3.2 (out of 10). Measured against a quality-of-life question, a meaningful improvement was about 1 point. The authors concluded the questionnaire was valid, reliable and responsive. They noted they could not tell whether it detects drug benefits, because treatment groups were not in their dataset.

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: Secondary analysis of questionnaire data from a randomized, open-label Phase II drug trial (psychometric validation study); analysis was blind to treatment arm
• Who was studied: 248 patients with advanced or metastatic malignant pleural mesothelioma (MPM) that overexpressed mesothelin and had progressed on first-line treatment. Ages 42 to 84 (median 66), 26% women, 94% white. 239 completed the questionnaires at baseline. Location and dates are not stated.
• Exposure: No asbestos exposure was studied. Patients received intravenous anetumab ravtansine or vinorelbine in the trial, but the treatment arm was not in the analyzed dataset. The study evaluated the MDASI-MPM questionnaire (19 severity items, 6 interference items) against the LCSS-Meso and clinician-rated ECOG performance status.
• Main results:
  • At baseline, 47% of patients had moderate to severe fatigue (20% severe), and 39% had moderate to severe shortness of breath
  • Internal consistency (Cronbach alpha) at baseline was at least 0.88 for the severity subscale and 0.90 for the interference subscale; both were 0.91 or higher during treatment
  • Test-retest intraclass correlations one cycle apart were 0.86 (severity) and 0.88 (interference). These were calculated only for the 82 patients whose quality-of-life ratings showed relative stability.
  • Correlations between the two MDASI-MPM subscales and the LCSS-Meso score were higher than 0.70 at every assessment (0.73 to 0.80 in Table 3), P < 0.001
  • From baseline to Cycle 3 Day 1, fully active patients (ECOG PS 0) had significantly lower scores on both subscales than patients with poorer performance status (all P < 0.05). The confidence intervals in Table 4 include zero at Cycle 4, Cycle 5 and safety follow-up.
  • Among 50 patients whose performance status worsened from baseline to safety follow-up, mean symptom score rose from 2.2 to 3.2 (effect size 0.69) and mean interference from 2.8 to 5.0 (effect size 0.92)
  • Symptoms were more severe at the safety follow-up, about 21 weeks from baseline, than at baseline (2.1 vs 2.9, P < 0.001; n = 103)
  • Using the LCSS-Meso global quality-of-life item as anchor, meaningful improvement corresponded to about 1 point on the 0 to 10 scale (1.05 for symptoms, 1.07 for interference)
• The authors' conclusion: The authors concluded that the MDASI-MPM is a valid, reliable and responsive instrument for assessing the severity of symptoms in patients with MPM and how they interfere with daily functioning
• Limitations the authors state:
  • The authors could not determine whether the MDASI-MPM detects drug-related treatment benefits, because the treatment arm was not in the analytic dataset

Topics

Medical terms in this study, explained in our Lexicon: Pleural Mesothelioma, Performance Status.

Related studies

• Modification of existing patient-reported outcome measures: qualitative development of the MD Anderson Symptom Inventory for malignant pleural mesothelioma (MDASI-MPM) — L.A. Williams, M.S. Whisenant, et al. (2018)
• Satisfactory results of a psychometric analysis and calculation of minimal clinically important differences of the World Health Organization quality of life-BREF questionnaire in an observational cohort study with lung cancer and mesothelioma patients — M. de Mol, S. Visser, et al. (2018)
• Developing a fit-for-purpose composite symptom score as a symptom burden endpoint for clinical trials in patients with malignant pleural mesothelioma — C.S. Cleeland, K.N. Keating, et al. (2024)
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• Multifactorial Evaluation following Cytoreductive Surgery for Malignant Pleural Mesothelioma in Patients with High Symptom-Burden — R. Tajè, R. Fiorito, et al. (2022)
• Observer variability in mesothelioma tumor thickness measurements: defining minimally measurable lesions — S.G. Armato, A.K. Nowak, et al. (2014)

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