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

Gelhorn, Heather L.; Skalicky, Anne; Balantac, Zaneta; Eremenco, Sonya; Cimms, Tricia; Halling, Katarina; Hollen, Patricia J.; Gralla, Richard J.; Mahoney, Martin C.; Sexton, Chris C.

doi:10.1007/s00520-018-4061-0

Cited by 10 publications

(10 citation statements)

References 12 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Fatigue is common, with up to 86% of participants in the intervention arm of our study reporting such (from the SPARC tool), and at least 27% reporting "tiredness" in the overall cohort (from the QLQ-C30). This is consistent with other studies, reporting rates between 61-94% 2,29 . Fatigue is a difficult symptom to manage and is perhaps related to pro-inflammatory cytokines which are themselves related to the neutrophil-lymphocyteratio and vascular endothelial growth factor 16 .…”

Section: Independence and Support/familysupporting

confidence: 94%

See 1 more Smart Citation

Symptom Burden and Unmet Needs in Malignant Pleural Mesothelioma: Exploratory Analyses From the RESPECT-Meso Study

Hoon

Lawrie

et al. 2020

J Palliat Care

View full text Add to dashboard Cite

Objective: Malignant Pleural Mesothelioma (MPM) has a poor prognosis and high symptom burden. RESPECT-Meso was a multicenter randomized study examining the role of early specialist palliative care (SPC) on quality of life (QoL) with MPM. This is a post-hoc exploratory analysis of the symptom burden and unmet needs identified from RESPECT-Meso participants. Methods: Exploratory analysis from 174 participants using the General Health Status (GHS) measure (from the EORTC QLQ-C30 QoL questionnaire) and 87 participants using validated assessment questionnaires in those randomized to SPC. Eligibility for the study included confirmed MPM with diagnosis <6 weeks prior, performance score (PS) 0 or 1, no significant physical or psychological comorbidity. Cox proportional hazards models were derived to examine for relationships with survival. Free text was assessed using content analysis, looking for common themes and words. Results: Participants were predominantly male (79.9%), mean age 72.8 years, PS was 0 in 38%, 78% of MPM was epithelioid. At least 3 symptoms were reported in 69.8% of participants, including fatigue (81%), dyspnea (73.3%), pain (61.2%), weight loss (59.3%). Anxiety was reported by 54.7% of participants, 52.3% low mood and 48.8% anhedonia symptoms. After multivariable adjustment, only pain remained statistically significant with a hazard ratio (HR) 2.9 (95% CI 1.3-6.7; p = 0.01). For each 1 unit increase in GHS score, the HR for death was 0.987 (0.978-0.996; p = 0.006), indicating a worse reported QoL is related to shorter survival. Unmet needs were common: 25.9% wanted more information about their condition, 24.7% about their care and 21.2% about their treatment. 79.1% were concerned about the effect of their illness on family. Conclusion: There is a high symptom burden in mesothelioma despite good baseline performance status. A worse QoL is associated with a worse survival. Unmet needs are common, perhaps highlighting a need for improved communication and information sharing.

show abstract

Section: Independence and Support/familysupporting

confidence: 94%

“…Fatigue was also a prominent physical symptom in our study, in common with other reports 28,29 . It is a key physical symptom predictive of survival and an established unmet need within the cancer population 9,17 .…”

Section: Independence and Support/familysupporting

confidence: 92%

Symptom Burden and Unmet Needs in Malignant Pleural Mesothelioma: Exploratory Analyses From the RESPECT-Meso Study

Hoon

Lawrie

et al. 2020

J Palliat Care

View full text Add to dashboard Cite

show abstract

“…The MDASI-MPM was developed according to the general principles expressed in the FDA’s guidance on the use of PROs in labeling claims [4], including qualitative generation of items. While none of the HRQOL measures validated for use in patients with MPM were developed with qualitative input from patients with MPM, a recent paper [5] evaluated the content validity of the LCSS-Meso in qualitative interviews with patients with MPM, although an expert panel evaluation of the relevance of these symptoms was not done. This study found that the symptoms reported by 20% or more of the 18 patients with MPM interviewed were shortness of breath, fluid build-up, coughing, fatigue, pain, weight loss, and appetite changes.…”

Section: Discussionmentioning

confidence: 99%

“…The LCSS-Meso is a valid and reliable QOL measure that was designed for patients with non-small cell lung cancer and that has been modified for use in patients with MPM. A recent paper [5] presents cognitive debriefing of the LCSS-Mesothelioma. One of the 8 items in the LCSS-Meso is a global QOL rating (rated using a visual analogue scale on a 0–100 scale).…”

Section: Methodsmentioning

confidence: 99%

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

View full text Add to dashboard Cite

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.

show abstract

“…Patients managing chronic conditions have reported satisfaction in web-based reporting systems that facilitate effective communication of biomedical metrics (eg, blood pressure and weight) [ 11 ]. Recent studies have demonstrated the usability and implementation of HIT platforms to collect electronic patient-reported outcomes (ePROs), such as biomedical metrics for disease management [ 12 - 14 ].…”

Section: Introductionmentioning

confidence: 99%

Using Electronic Data Collection Platforms to Assess Complementary and Integrative Health Patient-Reported Outcomes: Feasibility Project

Haun¹,

Alman²,

Melillo³

et al. 2020

JMIR Med Inform

View full text Add to dashboard Cite

Background The Veteran Administration (VA) Office of Patient-Centered Care and Cultural Transformation is invested in improving veteran health through a whole-person approach while taking advantage of the electronic resources suite available through the VA. Currently, there is no standardized process to collect and integrate electronic patient-reported outcomes (ePROs) of complementary and integrative health (CIH) into clinical care using a web-based survey platform. This quality improvement project enrolled veterans attending CIH appointments within a VA facility and used web-based technologies to collect ePROs. Objective This study aimed to (1) determine a practical process for collecting ePROs using patient email services and a web-based survey platform and (2) conduct analyses of survey data using repeated measures to estimate the effects of CIH on patient outcomes. Methods In total, 100 veterans from one VA facility, comprising 11 cohorts, agreed to participate. The VA patient email services (Secure Messaging) were used to manually send links to a 16-item web-based survey stored on a secure web-based survey storage platform (Qualtrics). Each survey included questions about patient outcomes from CIH programs. Each cohort was sent survey links via Secure Messaging (SM) at 6 time points: weeks 1 through 4, week 8, and week 12. Process evaluation interviews were conducted with five primary care providers to assess barriers and facilitators to using the patient-reported outcome survey in usual care. Results This quality improvement project demonstrated the usability of SM and Qualtrics for ePRO collection. However, SM for ePROs was labor intensive for providers. Descriptive statistics on health competence (2-item Perceived Health Competence Scale), physical and mental health (Patient-Reported Outcomes Measurement Information System Global-10), and stress (4-item Perceived Stress Scale) indicated that scores did not significantly change over time. Survey response rates varied (18/100, 18.0%-42/100, 42.0%) across each of the 12 weekly survey periods. In total, 74 of 100 participants provided ≥1 survey, and 90% (66/74) were female. The majority, 62% (33/53) of participants, who reported the use of any CIH modality, reported the use of two or more unique modalities. Primary care providers highlighted specific challenges with SM and offered solutions regarding staff involvement in survey implementation. Conclusions This quality improvement project informs our understanding of the processes currently available for using SM and web-based data platforms to collect ePROs. The study results indicate that although it is possible to use SM and web-based survey platforms for ePROs, automating scheduled administration will be necessary to reduce provider burden. The lack of significant change in ePROs may be due to standard measures taking a biomedical approach to wellness. Future work should focus on identifying ideal ePRO processes that would include standardized, whole-person measures of wellness.

show abstract

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

Abstract: 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.

Cited by 10 publications

References 12 publications

Symptom Burden and Unmet Needs in Malignant Pleural Mesothelioma: Exploratory Analyses From the RESPECT-Meso Study

Symptom Burden and Unmet Needs in Malignant Pleural Mesothelioma: Exploratory Analyses From the RESPECT-Meso Study

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

Using Electronic Data Collection Platforms to Assess Complementary and Integrative Health Patient-Reported Outcomes: Feasibility Project

Contact Info

Product

Resources

About