BACKGROUND: Reunion Island, a French overseas department, is located in the southern hemisphere, close to the Capricorn tropic. This island has a multicultural and multiethnic population of 860 000 inhabitants, a quarter of whom are at high risk of developing skin cancer due to intense ultraviolet radiation. Melanoma is responsible for the majority of skin cancer deaths. The early prevention of melanoma is based on sun protection in childhood, but French regulations are not adapted to the environmental conditions of this tropical region.The main objective of our study is to evaluate the effectiveness of three sun protection programs conducted in Reunionese primary schools through a pupil knowledge questionnaire.
METHODS: PRESOLRE is an interventional, open-label, cluster-randomised controlled trial, in four parallel arms, that is being conducted throughout 2022-2023 on Reunion Island. The trial design assumes an escalation interventional effect using: first, a control arm without proposed intervention (arm 1); second, an arm whose classes are encouraged to use the validated educational programme \'Living With the Sun\' (LWS) (arm 2); third, an arm whose classes are encouraged to use both \'LWS\' combined with \'Mission Soleil Réunion\'s sun protection awareness programme (arm 3); fourth, an arm benefiting from an intervention similar to arm 3, combined with the distribution of hats, sunglasses and sun creams (arm 4). In all, 1780 pupils from 18 classes of 20 pupils, on average, will be included. Randomisation applies to the classes of pupils (so defined as clusters). The primary outcome is based on the proportion of correct answers to the knowledge questions after the awareness programme, compared between the four arms using a linear mixed model with random intercept.
BACKGROUND: The study obtained ethics approval in 2022 (ID: 2022-A00350-43). Results will be published in peer-reviewed journals.
BACKGROUND: NCT05367180.

BACKGROUND: Inflammation is a hallmark of cancer and is involved in tumour growth and dissemination. However, the hallmarks of cancer are also the hallmarks of wound healing, and modulating the wound inflammatory response and immune contexture in relation to cancer surgery may represent effective targets of therapies.Repurposing anti-inflammatory drugs in a cancer setting has gained increasing interest in recent years. Interestingly, the known and thoroughly tested antifibrinolytic drug tranexamic acid reduces the risk of bleeding, but it is also suggested to play important roles in anti-inflammatory pathways, improving wound healing and affecting anti-carcinogenic mechanisms.As a novel approach, we will conduct a randomised controlled trial using perioperative treatment with tranexamic acid, aiming to prevent early relapses by >10% for patients with melanoma.
METHODS: Design: investigator-initiated parallel, two-arm, randomised, blinded, Danish multicentre superiority trial.
METHODS: ≥T2 b melanoma and eligible for sentinel lymph node biopsy (n=1204).Project drug: tranexamic acid or placebo.
METHODS: before surgery (intravenous 15 mg/kg) and daily (peroral 1000 mg x 3) through postoperative day 4.
METHODS: relapse within 2 years after surgery.Primary analysis: risk difference between the treatment arms (χ2 test).
RESULTS: postoperative complications, adverse events and survival.Inclusion period: summer 2023 to summer 2026.
BACKGROUND: The trial will be initiated during the summer of 2023 and is approved by the National Committee on Health Research Ethics, the Danish Medicine Agency, and registered under the Data Protection Act. The study will be conducted in accordance with the principles of the Declaration of Helsinki and Good Clinical Practice. Patients included in the study will adhere to normal Danish treatment protocols and standards of care, and we expect only mild and temporary side effects. Positive and negative results will be published in peer-reviewed journals, with authorships adhering to the Vancouver rules.
BACKGROUND: NCT05899465; ClinicalTrials.gov Identifier.

Diagnosing invasive cutaneous melanoma (CM) can be challenging due to subjectivity in distinguishing equivocal nevi, melanoma in situ and thin CMs. The underlying molecular mechanisms of progression from nevus to melanoma must be better understood. Identifying biomarkers for treatment response, diagnostics and prognostics is crucial. Using biomedical data from biobanks and population-based healthcare data, translational research can improve patient care by implementing evidence-based findings. The BioMEL biobank is a prospective, multicentre, large-scale biomedical database on equivocal nevi and all stages of primary melanoma to metastases. Its purpose is to serve as a translational resource, enabling researchers to uncover objective molecular, genotypic, phenotypic and structural differences in nevi and all stages of melanoma. The main objective is to leverage BioMEL to significantly improve diagnostics, prognostics and therapy outcomes of patients with melanoma.
The BioMEL biobank contains biological samples, epidemiological information and medical data from adult patients who receive routine care for melanoma. BioMEL is focused on primary and metastatic melanoma, but equivocal pigmented lesions such as clinically atypical nevi and melanoma in situ are also included. BioMEL data are gathered by questionnaires, blood sampling, tumour imaging, tissue sampling, medical records and histopathological reports.
The BioMEL biobank project is approved by the national Swedish Ethical Review Authority (Dnr. 2013/101, 2013/339, 2020/00469, 2021/01432 and 2022/02421-02). The datasets generated are not publicly available due to regulations related to the ethical review authority.
NCT05446155.

To identify prognostic models for melanoma survival, recurrence and metastasis among American Joint Committee on Cancer stage I and II patients postsurgery; and evaluate model performance, including overall survival (OS) prediction.
Systematic review and narrative synthesis.
Searched MEDLINE, Embase, CINAHL, Cochrane Library, Science Citation Index and grey literature sources including cancer and guideline websites from 2000 to September 2021.
Included studies on risk prediction models for stage I and II melanoma in adults ≥18 years. Outcomes included OS, recurrence, metastases and model performance. No language or country of publication restrictions were applied.
Two pairs of reviewers independently screened studies, extracted data and assessed the risk of bias using the CHecklist for critical Appraisal and data extraction for systematic Reviews of prediction Modelling Studies checklist and the Prediction study Risk of Bias Assessment Tool. Heterogeneous predictors prevented statistical synthesis.
From 28 967 records, 15 studies reporting 20 models were included; 8 (stage I), 2 (stage II), 7 (stages I-II) and 7 (stages not reported), but were clearly applicable to early stages. Clinicopathological predictors per model ranged from 3-10. The most common were: ulceration, Breslow thickness/depth, sociodemographic status and site. Where reported, discriminatory values were ≥0.7. Calibration measures showed good matches between predicted and observed rates. None of the studies assessed clinical usefulness of the models. Risk of bias was high in eight models, unclear in nine and low in three. Seven models were internally and externally cross-validated, six models were externally validated and eight models were internally validated.
All models are effective in their predictive performance, however the low quality of the evidence raises concern as to whether current follow-up recommendations following surgical treatment is adequate. Future models should incorporate biomarkers for improved accuracy.
CRD42018086784.

Skin cancer is Australia\'s most common and costly cancer. We examined the frequency of Australian general practice consultations for skin cancer-related conditions, by patient and general practitioner (GP) characteristics and by time period.
Nationally representative, cross-sectional survey of general practice clinical activity.
Patients aged 15 years or older having a skin cancer-related condition managed by GPs in the Bettering the Evaluation And Care of Health study between April 2000 and March 2016.
Proportions and rates per 1000 encounters.
In this period, 15 678 GPs recorded 1 370 826 patient encounters, of which skin cancer-related conditions were managed 65 411 times (rate of 47.72 per 1000 encounters, 95% CI 46.41 to 49.02). Across the whole period, \'skin conditions\' managed were solar keratosis (29.87%), keratinocyte cancer (24.85%), other skin lesion (12.93%), nevi (10.98%), skin check (10.37%), benign skin neoplasm (8.76%) and melanoma (2.42%). Over time, management rates increased for keratinocyte cancers, skin checks, skin lesions, benign skin neoplasms and melanoma; but remained stable for solar keratoses and nevi. Skin cancer-related encounter rates were higher for patients aged 65-89 years, male, living in Queensland or in regional or remote areas, with lower area-based socioeconomic status, of English-speaking background, Veteran card holders and non-healthcare card holders; and for GPs who were aged 35-44 years or male.
These findings show the spectrum and burden of skin cancer-related conditions managed in general practice in Australia, which can guide GP education, policy and interventions to optimise skin cancer prevention and management.

暂无摘要。

The COVID-19 pandemic has changed aspects of patient care in the many scheduled medical activities, restricted access to healthcare facilities, and affected the diagnosis and organisation of patients with other health problems, specifically skin cancer. Skin cancer, the uninhibited progress of atypical skin cells, happens with unrepaired DNA genetic faults that lead them to multiply and create malignant tumours. Currently, dermatologists perform skin cancer diagnosis based on their specialised experience using the results of pathological tests from the skin biopsy. Sometimes, some specialists advise sonography imaging to check the skin tissue as a non-invasive method. The outbreak has led to postponements in the treatment and diagnosis of patients with skin cancer, including diagnostic delays because of limitations of diagnostic capacities and delays in referring patients to the physician. The purpose of this review is to improve our understanding of the impact of the COVID-19 outbreak on the diagnosis of patients with skin cancer and conduct a scoping review to identify whether routine skin cancer diagnoses are affected by the persistent incidence of COVID-19.
The structure of research was compiled using Population/Intervention/Comparison/Outcomes/Study Design and Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. First, we will find the main keywords to capture scientific studies related to the impact of the COVID-19 pandemic on the diagnosis of skin cancer: COVID-19 and skin neoplasms. To warrant sufficient coverage and identify potential articles, we will search the combination of four electronic databases PubMed/MEDLINE, Scopus, Web of Science and EMBASE, and ProQuest from 1 January 2019 until 30 September 2022. The screening, selection and data extraction of studies will be performed by two independent authors, who will then assessed the quality of the included studies according to Newcastle-Ottawa Scale.
As this study will be a systematic review without human participants\' involvement, no formal ethical assessment is required. Findings will be presented at conferences related to this field and will be disseminated in a peer-reviewed journal.
CRD42022361569.

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.
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.
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).

The benefits of patient-reported feedback, using questionnaires that allow patients to report how they feel and function without any interpretation from healthcare professionals, are well established. However, patient-reported outcomes measures (PROMs) are not routinely collected in patients with melanoma in Australia. The aim of this study is to evaluate the feasibility and acceptability of implementing electronic PROMs (ePROMs) into routine care from the perspectives of patients with stage III melanoma and their treating clinical team.
A minimum of 50 patients and 5 clinicians will be recruited to this prospective, longitudinal pilot study (ePROMs-MELanoma). The study uses a mixed-methods approach (quantitative PROMs questionnaires and end-of-study surveys with qualitative interviews) and commenced in May 2021 in surgical and medical melanoma clinics at two sites in metropolitan Sydney, Australia. The primary outcomes are measures of feasibility and acceptability, comprising descriptive questionnaire completion statistics, and proportion of patients who reported that these PROMs were easy to complete and measured items they considered important. Clinician and clinic staff views will be canvassed on the appropriateness of these PROMs for their patients, change in referral practice and uptake and incorporation into routine practice. Secondary aims include measurement of improvements in patients\' emotional and physical health and well-being, and utility of real-time data capture and clinician feedback. All participants will complete the Distress Thermometer and EQ-5D-5L questionnaires in the clinic using a tablet computer at baseline and two to three subsequent follow-up appointments. Participants who report a score of 4 or higher on the Distress Thermometer will be triaged to complete an additional three questionnaires: the QLQ-C30, Depression, Anxiety and Stress Scale and Melanoma Concerns Questionnaire-28. Results will be generated in real time; patients with psychosocial distress or poor quality of life will discuss possible referral to appropriate allied health services with their clinician. Thematic analysis of interviews will be conducted.
Ethics approval obtained from St Vincent\'s Hospital Human Research Ethics Committee on 19 September 2019 (2019/ETH10558), with amendments approved on 8 June 2022. Patient consent is obtained electronically prior to questionnaire commencement. Dissemination strategies will include publication in peer-reviewed journals and presentation at international conferences, tailored presentations for clinical societies and government bodies, organisational reporting through multidisciplinary meetings and research symposia for local clinicians and clinic staff, and more informal, lay reports and presentations for consumer melanoma representative bodies and patient participants and their families.
ACTRN12620001149954.

A prerequisite for patient-centredness in healthcare organisations is offering patients access to adequate health information, which fits their needs. A personalised digital care pathway (PDCP) is a tool that facilitates the provision of tailored and timely information. Despite its potential, barriers influence the implementation of digital tools in healthcare organisations. Therefore, we investigated the perceived barriers and facilitators for implementation of the PDCP among stakeholders.
A qualitative study was conducted to acquire insight into perceptions of the stakeholders involved in the implementation of a digital care pathway in three diverse patient groups.
This study is part of the PDCP research project in a large academic hospital in the Netherlands.
Purposive sampling was used to recruit internal stakeholders (eg, healthcare professionals, employees of the supporting departments) and external stakeholders (eg, employees of the external PDCP supplier). In addition, existing semistructured interviews with patients involved in pilot implementation (n=24) were used to verify the findings.
We conducted 25 semistructured interviews using the Consolidated Framework for Implementation Research. Content analyses yielded four themes: (1) stakeholders\' perceptions of the PDCP (eg, perceived usefulness); (2) characteristics of the individuals involved and the implementation process (eg, individuals express resistance to change); (3) organisational readiness (eg, lack of resources); and (4) collaboration within the organisation (eg, mutual communication, multidisciplinary codesign). The main barriers mentioned by patients were duration of first activation and necessity for up-to-date content. In addition, the most facilitating factor for patients was user-friendliness.
Our findings emphasise the importance of gaining insights into the various perspectives of stakeholder groups, including patients, regarding the implementation of the PDCP. The perceived barriers and facilitators can be used to improve the PDCP implementation plan and tailor the development and improvement of other digital patient communication tools.