Developing an Australian Melanoma Clinical Outcomes Registry (MelCOR): a protocol paper

Introduction
Australia has the highest incidence of melanoma in the world with variable care provided by a diverse range of clinicians. Clinical quality registries aim to identify these variations in care and provide anonymised, benchmarked feedback to clinicians and institutions to improve patient outcomes. The Australian Melanoma Clinical Outcomes Registry (MelCOR) aims to collect population-wide, clinical-level data for the early management of cutaneous melanoma and provide anonymised feedback to healthcare providers.

Methods and analysis
A modified Delphi process will be undertaken to identify key clinical quality indicators for inclusion in the MelCOR pilot. MelCOR will prospectively collect data relevant to these quality indicators, initially for all people over the age of 18 years living in Victoria and Queensland with a melanoma diagnosis confirmed by histopathology, via a two-stage recruitment and consent process. In stage 1, existing State-based cancer registries contact the treating clinician and provide an opportunity for them to opt themselves or their patients out of direct contact with MelCOR. After stage 1, re-identifiable clinical data are provided to the MelCOR under a waiver of consent. In stage 2, the State-based cancer registry will approach the patient directly and invite them to opt in to MelCOR and share identifiable data. If a patient elects to opt in, MelCOR will be able to contact patients directly to collect patient-reported outcome measures. Aggregated data will be used to provide benchmarked, comparative feedback to participating institutions/clinicians.

Ethics and dissemination
Following the successful collection of pilot data, the feasibility of an Australia-wide roll out will be evaluated. Key quality indicator data will be the core of the MelCOR dataset, with additional data points added later. Annual reports will be issued, first to the relevant stakeholders followed by the public. MelCOR is approved by the Alfred Ethics Committee (58280/127/20).

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Settembre 2022

Melanoma Overdiagnosis Is Not the Key Problem—Reply

In Reply We are pleased that Paiva and Weinstock agree that overdiagnosis occurs in melanoma (and other cancers), as the evidence for its existence is overwhelming. As we indicated in our article, part of the rise in melanoma represents true disease, which is mostly concentrated among White men, the only demographic group for whom melanoma mortality was increasing before the advent of immunotherapy and targeted therapy for metastatic melanoma. However, true increases in melanoma mortality must be placed in the proper context; while melanoma mortality increased slightly from 1975 to 2013 (about 1 per 100 000; from 2.3 to 3.1 per 100 000), melanoma incidence increased markedly (about 45 per 100 000; from 9.2 to 55.1 per 100 000).

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Settembre 2022

Melanoma Overdiagnosis Is Not the Key Problem

To the Editor We read with interest the article by Adamson et al regarding overdiagnosis of malignant melanoma (MM). The authors attribute to overdiagnosis the increasing incidence of MM in non-Hispanic White patients, which is not accompanied by an increase in mortality after adjusting for the incidence to mortality ratios in Black patients. We do not dispute that overdiagnosis occurs, as has been shown in randomized clinical trials of life-saving screening with computed tomography scans or mammography for other cancers. Rather, we contend that for melanoma, there is a real increase in incidence, and that the morbidity and costs associated with overdiagnosis do not outweigh the potential reduction in morbidity and death of melanoma primary prevention and early detection.

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Settembre 2022

Describing, predicting and explaining adherence to total skin self-examination (TSSE) in people with melanoma: a 12-month longitudinal study

Objectives
To describe trajectories in melanoma survivors’ adherence to monthly total skin self-examination (TSSE) over 12 months, and to investigate whether adherence trajectories can be predicted from demographic, cognitive or emotional factors at baseline.

Design
A longitudinal observational study nested within the intervention arm of the ASICA (Achieving Self-Directed Integrated Cancer Aftercare) randomised controlled trial.

Setting
Follow-up secondary care in Aberdeen and Cambridge UK.

Participants
n=104 adults (48 men/56 women; mean age 58.83 years, SD 13.47, range 28–85 years; mean Scottish Index of Multiple Deprivation score 8.03, SD 1.73, range 2–10) who had been treated for stage 0–IIC primary cutaneous melanoma in the preceding 60 months and were actively participating in the intervention arm of the ASICA trial.

Interventions
All participants were using the ASICA intervention—a tablet-based intervention designed to support monthly TSSE.

Primary and secondary outcome measures
The primary outcome was adherence to guideline recommended (monthly) TSSE over 12 months. This was determined from time-stamped TSSE data recorded by the ASICA intervention app.

Results
Latent growth mixture models identified three TSSE adherence trajectories (adherent –41%; drop-off –35%; non-adherent –24%). People who were non-adherent were less likely to intend to perform TSSE as recommended, intending to do it more frequently (OR=0.21, 95% CI 0.06 to 0.81, p=0.023) and were more depressed (OR=1.31, 95% CI 1.06 to 1.61, p=0.011) than people who were adherent. People whose adherence dropped off over time had less well-developed action plans (OR=0.78, 95% CI 0.63 to 0.96, p=0.016) and lower self-efficacy about TSSE (OR=0.92, 95% CI 0.86 to 0.99, p=0.028) than people who were adherent.

Conclusions
Adherence to monthly TSSE in people treated for melanoma can be differentiated into adherent, drop-off and non-adherent trajectories. Collecting information about intentions to engage in TSSE, depression, self-efficacy and/or action planning at outset may help to identify those who would benefit from additional intervention.

Trial registration number
ClinicalTrials.gov Registry (NCT03328247).

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Agosto 2022

To identify the association between dietary vitamin D intake and serum levels and risk or prognostic factors for melanoma-systematic review and meta-analysis

Objective
To evaluate the association of serum vitamin D levels and dietary intake with melanoma risk and prognostic factors.

Methods
Two independent investigators systematically searched PubMed, Embase and ISI Web of Knowledge (Thomson Scientific Technical Support, New York) databases for eligible studies published between January 1992 and September 2020 using the following combinations of search terms: (vitamin D, or 25-hydroxyvitamin D) AND (melanoma, malignant melanoma, cutaneous melanoma, or cutaneous malignant melanoma). Articles not written in English but with English titles and abstracts were also checked. We obtained the full text of all potentially eligible articles, and reference lists of all studies retrieved at the first stage were also checked to identify other eligible papers. Review articles not reporting original data were excluded, but their reference lists were inspected.

Results
Six studies including 212 723 cases reported the association between dietary intake of 25(OH) D serum levels and melanoma risk. The total relative risk for the comparison between the highest and lowest quantiles of the distribution of vitamin D intake was 1.10 (95% CI 0.96 to 1.26) with I2=56%. Another six studies including 12 297 cases evaluated the association between serum vitamin D levels and melanoma risk. The total relative risk for the comparison of serum vitamin D levels between the highest and lowest quantiles was 1.12 (95% CI 0.53 to 2.35) with I2=91%. Four studies with 2105 cases investigated the association between serum 25(OH)D (nmol/L) and Breslow thickness, three of which found an inverse association between serum 25(OH)D (nmol/L) and melanoma thickness.

Conclusions
Vitamin D intake and serum 25(OH)D levels were not closely related with melanoma risk, but an inverse association between serum 25(OH)D levels with melanoma thickness was discovered. As the positive correlation between melanoma thickness and melanoma mortality has been recognised, hence it is concluded that a moderate dietary vitamin D supplement to avoid the serum 25(OH)D deficient might be beneficial to the long-term survival of patients with melanoma.

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Agosto 2022