Artistic depiction of a melanoma cell targeted by shields, illustrating the cellular fight against skin cancer, emphasizing research and cure: © Татьяна Креминская – stock.adobe.com
A systemic review evaluating patient-reported outcomes (PROMs) commonly used in melanoma research and clinical practice revealed high heterogeneity as 124 studies used 110 unique PROMs, with only 17 PROMs (15%) using melanoma-specific validation data, according to a study published in JAMA Dermatology.1 The study underscores the need for standardized, validated tools to ensure accurate measurement of PROMs.
The findings illustrate the challenge to compare results across research or translate data to clinical practice. The most commonly measured outcomes included emotional and psychological well-being (25% of PROMs), health-related quality of life (19%), and self-functioning, efficacy, and coping strategies (18%).
A total of 18 studies were identified that reported melanoma-specific validation data for these 17 PROMs, of which 14 (78%) were specifically psychometric validation studies and only 7 (41%) had a validation score of 4 or greater. Although only the Functional Assessment of Cancer Therapy-Melanoma (FACT-M) questionnaire was fully validated, other tools such as the Melanoma Concerns Questionnaire, the Supportive Care Needs Survey-Melanoma Module (SCNS-MM), and the Fear of Cancer Recurrence Inventory were partially validated.
This lack of validation raises concerns about whether these tools accurately capture the experiences of melanoma patients, particularly in longitudinal studies where detecting meaningful changes over time is critical.
Study Details
A total of 30,895 abstracts were screened from 136 articles detailing 124 studies compiled from MEDLINE, Embase, Web of Science Index Medicus, CINAHL, the Cochrane Central Register of Controlled Trials, and PsychINFO databases, which totalled 32,784 patients.
Eligible study designs included individually and cluster randomized clinical trials, quasi-experimental trials, pre-post studies (controlled and uncontrolled), intermittent time series, cohort studies, and cross-sectional studies. Meta-analyses, systematic reviews, and Cochrane reviews were also reviewed to identify any individual studies missed by the search strategy. The full cohort of studies included 52 cross-sectional studies (41%), 31 randomized clinical trials (25%), 23 longitudinal studies (19%), 8 pre-post studies (6%),6 cohort studies (5%), 1 retrospective analysis (1%), 1 phase IV trial (1%), 1 protocol (1%), and 1 quasi-experimental trial (1%).
Ineligible studies included case series, case studies, case reports, opinion, editorial, and commentary articles, letters to the editor, and conference abstracts.
Male and female patients of any age with any-stage cutaneous melanoma were included. Patients with other cancer types were only included if outcomes were reported separately for patients affected by melanoma. Patients with ocular melanoma, mucosal melanoma, or patients at high for melanoma but who were not diagnosed were excluded.
Clinical Implications
The investigators identified a number of implications after conducting this review. Unvalidated tools may lead to measurement errors, misinforming treatment decisions or support strategies. The high heterogeneity makes study comparisons difficult and hinders efforts to consolidate the available evidence for meta-analysis.
As a result, it poses a challenge for clinical practice guidelines to recommend appropriate PROMs for a specific outcome in routine practice. The investigators recommend that PROMs that are validated for use in melanoma populations should be prioritized in future research.
Further, 85% of the identified PROMs did not have melanoma-specific validation data available. The review emphasizes the importance of core outcome tests and recommends using validated melanoma-specific PROMs where available. For example, to measure health-related quality of life, the FACT-M or Melanoma Concerns Questionnaire are suggested. For assessing unmet needs, the SCNS-MM is recommended, whereas the Fear of Cancer Recurrence Questionnaire-7 item is highlighted for evaluating recurrence anxiety.
The investigators concluded that although PROMs are important for capturing patients perspectives in their care, variability and lack of validation lack their utility. For now community oncologists should critically evaluate the PROMs they use, favoring melanoma-specific validated tools where available.