Modification of existing patient-reported outcome measures: qualitative development of the MD Anderson Symptom Inventory for malignant pleural mesothelioma (MDASI-MPM)

Williams, Loretta A.; Whisenant, Meagan; Mendoza, Tito R.; Haq, Shireen; Keating, Karen; Cuffel, Brian J.; Cleeland, Charles S.

doi:10.1007/s11136-018-1982-5

Cited by 14 publications

(11 citation statements)

References 35 publications

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“…The results showed that within 7 days after surgery, symptom severity changed dramatically, which was consistent with the original study's ndings (6). Professionals should conduct effective symptom management based on patient-reported outcomes to improve their quality of life and outcomes ( [x], [xi]).…”

Section: Discussionsupporting

confidence: 75%

Translation and validation of the Chinese version of the MD Anderson Symptom Inventory for measuring perioperative symptom burden in patients with gynecologic cancer

Zhang

Zheng

Yang

et al. 2021

Preprint

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Background: Gynecologic cancers are among the most prevalent malignancies in China, and millions of gynecologic cancer patients are expected to undergo open abdominal surgery as initial treatment. The tumor- and surgery-related symptom burden are not well studied owing to a lack of a standardized and validated assessment tool in Chinese. The study was to translate and validate the MD Anderson Symptom Inventory for measuring perioperative symptom burden in gynecologic cancer patients (MDASI-PeriOp-GYN) and examine the utility of the Chinese version.Methods: The MDASI-PeriOp-GYN was translated in a stepwise manner. First, two native speakers independently translated the 9 PeriOp-GYN symptom items. Then the 9 items were translated back into English by another two bilingual translators. After discussion and revision, the four translators reached an agreement. The finalized Chinese version was administered to women with three common gynecologic cancer types (cervical, ovarian, and endometrial cancers) recruited from the gynecological oncology department of Sichuan Cancer Hospital & Institute between July and October 2019. Reliability and validity of the translated version were assessed. Results: Overall, 324 women with gynecologic cancers were enrolled. Cronbach’s α values were 0.826 and 0.735 for the symptom severity and interference scales, respectively. Test-retest reliability values were 0.885, 0.873, and 0.914 for the symptom severity, PeriOp-GYN, and interference scales, respectively. Significant correlations were found between the MDASI-PeriOp-GYN-C and EORTC QLQ-C30 along with the QLQ-OV28 module (-0.608–0.871, P<0.001). Known-group validity was supported by significant differences in the scores of the four scales grouped by time intervals, surgery type, and functional status (all P<0.01). Conclusions: The MDASI-PeriOp-GYN-C is a valid and reliable tool for measuring symptoms in Chinese patients undergoing surgery for gynecologic cancers. The tool could be used in clinical practice and clinical trials to instantly gather patients’ health and quality of life data.

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Section: Discussionsupporting

confidence: 75%

Translation and validation of the Chinese version of the MD Anderson Symptom Inventory for measuring perioperative symptom burden in patients with gynecologic cancer

Zhang

Zheng

Yang

et al. 2021

Preprint

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“…In this study, we tested a provisional MPM-specific version of the MD Anderson Symptom Inventory adapted to encompass major symptoms reported by patients with MPM over the duration of treatment. We adopted all of the MDASI-MPM items for psychometric testing on the basis of qualitative interviewing results that established the importance of each item [2]. This psychometric testing is a necessary step in the validation dossier of the MDASI-MPM.…”

Section: Discussionmentioning

confidence: 99%

“…The general principles expressed in the FDA’s guidance on the use of PROs in labeling claims [4] also recommends psychometric evaluation of the items and subscales in an early-phase study [2]. One of the criteria set forth in the FDA guidance is that a PRO instrument must be able to detect change over time.…”

Section: Discussionmentioning

confidence: 99%

“…The MDASI-MPM includes the 13 core MDASI symptoms and 6 MPM-specific items (feeling of malaise, coughing, muscle weakness, trouble with balance or falling, chest heaviness or tightness, and eye problems) that were developed using qualitative interviewing, a method favored by the FDA for item generation and development [4]. A summary of the item generation and development of the draft MDASI-MPM items on the basis of qualitative interviewing results is reported elsewhere [2]. For the psychometric analyses described in this paper, we included the additional symptoms identified during the qualitative development and evaluated psychometric evidence for their inclusion in the MDASI-MPM symptom severity subscale.…”

Section: Methodsmentioning

confidence: 99%

“…Building on our group’s extensive experience in developing symptom measures, we used a qualitative approach to adapt an existing multisymptom assessment questionnaire, the MD Anderson Symptom Inventory (MDASI), to include additional symptoms specific to the MPM experience. The resulting provisional version of the MDASI-MPM was based on a conceptual model of MPM-related symptom burden and was found to be content valid and amenable for further psychometric testing [2].…”

Section: Introductionmentioning

confidence: 99%

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

Mendoza

Williams

Keating

et al. 2019

J Patient Rep Outcomes

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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.

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New Developments in the Use of Patient-Reported Outcomes in Cancer Patients Undergoing Immunotherapies

Mendoza

2020

Advances in Experimental Medicine and Biology

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Modification of existing patient-reported outcome measures: qualitative development of the MD Anderson Symptom Inventory for malignant pleural mesothelioma (MDASI-MPM)

Abstract: The MDASI-MPM has established content validity and, with the addition of one symptom item, is ready for psychometric testing as fit-for-purpose for a clinical trial of an investigational agent.

Cited by 14 publications

References 35 publications

Translation and validation of the Chinese version of the MD Anderson Symptom Inventory for measuring perioperative symptom burden in patients with gynecologic cancer

Translation and validation of the Chinese version of the MD Anderson Symptom Inventory for measuring perioperative symptom burden in patients with gynecologic cancer

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

New Developments in the Use of Patient-Reported Outcomes in Cancer Patients Undergoing Immunotherapies

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