The use of patient-reported outcome measures (PROMs) in the management of malignant pleural mesothelioma: a descriptive literature survey
Original Article

The use of patient-reported outcome measures (PROMs) in the management of malignant pleural mesothelioma: a descriptive literature survey

Youssef Ben Bouazza1, Jan P. Van Meerbeeck1,2,3

1Faculty of Medicine and Health Care, Antwerp University, Antwerpen, Belgium;2Department of Pulmonology, Department of Thoracic Oncology, Antwerp University Hospital, Edegem, Belgium;3Multidisciplinary Oncological Center Antwerp (MOCA), Antwerp University Hospital, Edegem, Belgium

Contributions: (I) Conception and design: All authors; (II) Administrative support: Y Ben Bouazza; (III) Provision of study materials or patients: Y Ben Bouazza; (IV) Collection and assembly of data: Y Ben Bouazza; (V) Data analysis and interpretation: All authors; (VI) Manuscript writing: All authors; (VII) Final approval of manuscript: All authors.

Correspondence to: Youssef Ben Bouazza, BaM. Faculty of Medicine and Health Care, Antwerp University, Universiteitsplein 1, 2610 Antwerpen, Belgium. Email: youssef.benbouazza@student.uantwerpen.be.

Background: Malignant pleural mesothelioma (MPM) remains a highly symptomatic and aggressive malignancy. The treatment options are for most patients limited to palliative chemotherapy and best supportive care. Therefore, the use of patient-reported outcome measures (PROMs) is recommended for the improvement of the quality of care. The aim of this literature survey is to provide an up to date review of the use of PROMs in mesothelioma. A concise comparison is made of the identified instruments.

Methods: We searched PubMed, Web of Science and Google Scholar for the use of PROMs in MPM. Quality of the study and risk of bias were assessed using the appraisal tools recommended by the Dutch Cochrane Center.

Results: A total of 31 articles on PROMs in MPM were identified that met the inclusion criteria and a total of 14 instruments. The instruments are categorized in generic (n=2), cancer-specific (n=4), lung cancer-specific (n=3), mesothelioma-specific (n=2) and symptom-specific (n=3). They were mostly used in clinical trials.

Conclusions: PROMs have the potential to improve the management of MPM. No particular instrument is specifically recommended, although there is a preference for patient-reported disease-specific instruments encompassing the concept of health-related quality of life (hrQoL) and relevant symptoms. Such instruments are the EORTC QLQ-LC13, LCSS-Meso and FACT-L, which measure the impact of malignant mesothelioma and its treatment on patients. Assessments should be made on baseline and post-treatment. The frequency of assessments should be further evaluated in this population.

Keywords: Malignant pleural mesothelioma (MPM); patient-reported outcome measures (PROMs); health-related quality of life (hrQoL); questionnaires; quality improvement

Submitted Jan 01, 2018. Accepted for publication Jul 17, 2018.

doi: 10.21037/tlcr.2018.07.08

Introduction

Malignant pleural mesothelioma (MPM) is an aggressive malignancy arising from the mesothelial surfaces of the pleural cavity. This tumor was once rare, but its incidence is increasing worldwide (1). Overall survival is poor with an median survival of seven to 11 months after diagnosis (2).

Whereas most patients experience symptoms, the disease is already at an advanced stage. Up to 60% present with dyspnea, chest wall pain and pleural effusion. Other frequent symptoms are coughing, night sweats, weight loss, fatigue and a mass on the chest wall, all which have a significant impact on the health-related quality of life (hrQoL) (3). The treatment options are for most patients limited to palliative chemotherapy and best supportive care (BSC) (1).

Therefore, it is recommended to evaluate and preserve the symptoms and hrQoL. This can be achieved with patient-reported outcome measures (PROMs), which measure outcomes regarding the health of the patient and are directly reported by the patient. They can range from simple symptomatic to more complex concepts, such as hrQoL (4).

The aim of this literature survey is to provide an up to date review of the use of PROMs in mesothelioma. In line with a former review of PROMs in lung cancer (5), a concise comparison is made of the identified instruments.

Methods

This survey was conducted in accordance with the guideline Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) (6). The latest database search is conducted on 02 January 2018 in PubMed, Web of Science and Google scholar using the following search terms: (((“patient reported“ OR “patient related” OR “patient based” OR “patient centered” OR “self-reported”) AND (outcome OR outcomes OR measure*)) OR (prom OR proms OR pro OR pros) OR quality of life [MeSH Terms]) AND mesothelioma [MeSH Terms]. The Risk of Bias in included studies was assessed using the appraisal tools recommended by the Cochrane Netherlands (7). PROMs were included if they showed good psychometric properties (validity, reliability and responsiveness).

Results

The search yielded a total of 286 hits. After removing the duplicates, screening the titles and abstracts 216 articles were excluded. The remaining 72 articles were evaluated for full text, which led to the exclusion of an additional 45 articles. Therefore, a total of 31 articles on PROMs in MPM were identified that met the inclusion criteria (Figure 1).

Figure 1 Flowchart of study selection.

Most of these reports (Table 1) present the results of phase II (n=12) or III (n=8) clinical trials. PROMs are the primary outcome in 11 (34%) articles, and a secondary endpoint in the remaining 21 (66%). Of all 31 studies’ interventions, 22 (71%) assessed chemotherapy alone, 8 (26%) surgery with or without chemo/radiotherapy and 2 (7%) radiotherapy alone. Tables S1-S4 shows the risk of bias with poor quality of data in the phase II studies and descriptive series.

Table 1
Table 1 Identified literature overview
Full table
Table S1
Table S1 Risk of bias
Full table
Table S2
Table S2 Risk of bias
Full table
Table S3
Table S3 Risk of bias
Full table
Table S4
Table S4 Risk of bias
Full table

PROMs need good psychometric properties to be accepted as a scientific measure. Overall, 14 instruments were identified and included in this survey (in total online: http://tlcr.amegroups.com/public/system/tlcr/supp-tlcr.2018.07.08-6.pdf) (20,21,39-56). The instruments can be categorized in generic (n=2), cancer-specific (n=4), lung cancer-specific (n=3), mesothelioma-specific (n=2) and symptom-specific (n=3). The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-core module (EORTC QLQ-C30) was the most frequently used [in 19 (61%) of 31 studies]. In nine of the 19 studies, the EORTC QLQ-C30 was supplemented with the EORTC QLQ-lung cancer module (EORTC QLQ-LC13). The Rotterdam Symptom Checklist (RSCL) was used in four studies, like the Lung Cancer Symptom Scale (LCSS) of which in three studies the modified version for mesothelioma was used (LCSS-meso) (57-65).

Additional instruments used included Brief Pain Inventory (BPI), European Quality of Life-five dimensions (EQ-5D), Fatigue Severity Scale (FSS), Functional Assessment of Cancer Therapy-Lung (FACT-L), Hospital Anxiety and Depression Scale (HADS), Quality of Life Questionnaire for Cancer Patients Treated with Anti-Cancer Drugs (QOL-ACD), Medical Outcome Study 36-item Short-Form Health Survey (SF-36) and Symptom Distress Scale (SDS). Seventeen studies (55%) used more than one instrument. Furthermore, seven (23%) studies combined generic with disease-specific instruments.

Discussion

MPM remains a highly symptomatic and aggressive malignancy. The PROMs are of great importance for the improvement of the quality of care. PROMs were mostly included in clinical trials assessing chemotherapy, which is encouraged by the Food and Drug Administration (FDA) for labeling claims (66). Although the popularity of PROMs is still growing, they were already the primary endpoint in one third of all included studies. If PROMs were not the primary endpoint then they have become an important secondary endpoint in numerous studies. Since the clinical effectiveness of treatments in mesothelioma is still limited, their impact on the patient is considered crucial.

The phase II studies and descriptive series showed poor quality of data, which are the majority of the papers included in this review. The high rate of drop-outs was not even mentioned. Furthermore, the interpretation of the PROMs has not been described in the majority of the studies as reflected by Tables S1-S4. Based on these data it seems justified not to use PROMs in single arm studies.

In general, PROMs were measured by using well-known instruments with adequate psychometric properties. However, preference was given to disease-specific instruments as they are more sensitive for subtle changes. The EORTC QLQ-C30 in conjunction with the QLQ-LC13 is most frequently used. Besides the dominant EORTC instruments, a broad variety of other instruments were used (in total online: http://tlcr.amegroups.com/public/system/tlcr/supp-tlcr.2018.07.08-6.pdf). Despite being the only instrument available specific for the mesothelioma population, the LCSS-Meso was not used as frequently.

Because this malignancy is similar to lung cancer in terms of symptoms and survival, an entirely new instrument specific for mesothelioma is not considered necessary. Most lung cancer-specific instruments (EORTC QLQ-LC13, FACT-L and LCSS) have been validated in MPM showing good results (20,26,30). Still a new mesothelioma-specific instrument, the MD Anderson Symptom Inventory Malignant Pleural Mesothelioma (MDASI-MPM), is under development and has not yet been psychometrically validated. So there is a wide range of options for assessing PRO’s in MPM.

With no established instrument for measuring PROMs in MPM there are several aspects one should consider when choosing an instrument. The specific or more comprehensive instruments are more suited for routine use in the clinical practice. Brief and generic instruments such as the EQ-5D on the other hand put less of a burden on the patient. But the coarseness of the system with only three levels per item limits the responsiveness. In studies of patients undergoing therapy, ceiling effect problems may not be serious. In long-term follow up ceiling effect issues may be more problematic (67). Although most included instruments are suited for both routine care as clinical trials. The clinician/researcher should consider the domains, comprehensiveness/sensitivity/burden, psychometric properties, cost and aim when choosing the right instrument.

Conclusions

PROMs should not be used in single arm studies (grade 2C).

PROMs have the potential to improve the management of MPM. No particular instrument is specifically recommended, although there is a preference for patient-reported disease-specific instruments encompassing the concept of hrQoL and relevant symptoms. Such instruments are the EORTC QLQ-LC13, LCSS-Meso and FACT-L, which measure the impact of malignant mesothelioma and its treatment on patients (grade 1C).

Assessments should be made on baseline and post-treatment. The frequency of assessments should be further evaluated in this population (grade 2C).

Appendix: inclusion criteria

Studies that meet all inclusion criteria, without any exclusion criterion, were included. The criteria are: English language of publication; participants are MPM patients regardless of stage or treatment; PROMs are the primary or secondary endpoint of the study; evidence is available for the validity, reliability and responsiveness of PROMs. Exclusion criteria are: full-text not available; data is not patient-reported; studies about patient-reported experience measures (PREMs) instead of PROMs; protocols or case-reports.

Acknowledgements

None.

Footnote

Conflicts of Interest: The authors have no conflicts of interest to declare.

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Cite this article as: Ben Bouazza Y, Van Meerbeeck JP. The use of patient-reported outcome measures (PROMs) in the management of malignant pleural mesothelioma: a descriptive literature survey. Transl Lung Cancer Res 2018;7(5):507-515. doi: 10.21037/tlcr.2018.07.08

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