MelaNostrum: a consensus questionnaire of standardized epidemiologic and clinical variables for melanoma risk assessment by the melanostrum consortium

Abstract

Background: Many melanoma observational studies have been carried out across different countries and geographic areas using heterogeneous assessments of epidemiologic risk factors and clinical variables.

Aim: To develop a consensus questionnaire to standardize epidemiologic and clinical data collection for melanoma risk assessment.

Methods: We used a stepwise strategy that included: compilation of variables from case-control datasets collected at various centres of the MelaNostrum Consortium; integration of variables from published case-control studies; consensus discussion of the collected items by MelaNostrum members; revision by independent experts; addition of online tools and image-based charts; questionnaire testing across centres and generation of a final draft.

Results: We developed a core consensus questionnaire (MelanoQ) that includes four separate sections: A. general and demographic data; B. phenotypic and ultraviolet radiation exposure risk factors and lifestyle habits; C. clinical examination, medical and family history; and D. diagnostic data on melanoma (cases only). Accompanying online tools, informative tables, and image-based charts aid standardization. Different subsections of the questionnaire are designed for self-administration, patient interviews performed by a physician or study nurse, and data collection from medical records.

Conclusions: The MelanoQ questionnaire is a useful tool for the collection and standardization of epidemiologic and clinical data across different studies, centres, cultures and languages. This will expedite ongoing efforts to compile high-quality data for pooled analyses or meta-analyses and offer a solid base for the design of clinical, epidemiologic and translational studies on melanoma.

Figure 1. Open in figure viewerPowerPoint

Stepwise strategy used to develop the MelanoQ. *one meeting including patient examination to define criteria for pigmented lesion assessment and nevus count. **The expert panel consisted of M. Tucker (USA), V. Bataille (UK) and D. Whiteman (Australia). Step 1: compilation of variables from case–control datasets collected by the MelaNostrum centres. Step 2: distribution of the variable list to MelaNostrum members, initial evaluation of differences and similarities across centres and categorization of the items in sections. This step also included enrichment of the variables based on published case–control studies. Step 3: two face-to-face meetings of the MelaNostrum clinical core of investigators, during which each variable in the list was discussed. The first meeting also involved physical examination of patients to achieve consensus on criteria for nevus count and (other) pigmented skin lesion diagnosis. As a result, a draft of the MelanoQ was generated (Barcelona, Spain) and subsequently improved (Athens, Greece). Step 4: review of the draft questionnaire by an independent expert panel (MT, DW, VB) and implementation of the suggested modifications. Step 5: addition of (i) online tools to ease recording of residency and occupations, (ii) tables with lists of ethnicities, outdoor occupations and recreational activities, and (iii) image-based charts for data standardization pertaining to eye and hair colour, tanning ability, freckles and nevi number. Step 6: questionnaire testing across centres, using different languages and recording the time required for completion. Step 7: establishment of the final draft after consensus discussion through email exchange by the MelaNostrum team.