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The MEL-SELF trial is a randomised controlled trial of patient-led surveillance compared to clinician-led surveillance in people treated for localised cutaneous melanoma (stage 0, I, II). The primary trial aim is to determine if patient led-surveillance compared to clinician-led surveillance increases the proportion of participants who are diagnosed with a new primary or recurrent melanoma at a fast-tracked unscheduled clinic visit. The secondary outcomes include time to diagnosis of any skin cancer, psychosocial outcomes, acceptability, and resource use.The objective of this report is to outline and publish the pre-determined statistical analysis plan before the database lock and the start of analysis.The statistical analysis plan describes the overall analysis principles, including how participants will be included in each analysis, the presentation of the results, adjustments for covariates, the primary and secondary outcomes, and their respective analyses. In addition, we present the planned sensitivity and subgroup analyses. A separate analysis plan will be published for health economic outcomes.The MEL-SELF statistical analysis plan has been designed to minimize bias in estimating effects of the intervention on primary and secondary outcomes. By pre-specifying analyses, we ensure the study's integrity and believability while enabling the reproducibility of the final analysis.This detailed statistical analysis plan will help to ensure transparency of reporting of results from the MEL-SELF trial.Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12621000176864. Registered 18 February 2021, https://www.anzctr.org.au/ACTRN12621000176864.aspx.

Background: It is unclear how many incident patients with stage 5 chronic kidney disease (CKD) referred to nephrologists are presented with information about conservative care as a treatment option and how many plan not to dialyze. Study Design: National observational survey study with random-effects logistic regression. Setting & Participants: Incident adult and pediatric pre-emptive transplant, dialysis, and conservative-care patients from public and private renal units in Australia, July to September 2009. Predictors: Age, sex, health insurance status, language, time known to nephrologist, timing of information, presence of caregiver, unit conservative care pathway, and size of unit. Outcomes & Measurements: The 2 main outcome measures were information provision to incident patients about conservative care and initial treatment regardless of planned conservative care. Results: 66 of 73 renal units (90%) participated. 10 (15%) had a formal conservative-care pathway. Of 721 incident patients with stage 5 CKD, 470 (65%) were presented with conservative care as a treatment option and 102 (14%) planned not to dialyze; median age was 80 years. Multivariate analysis for information provision showed that patients older than 65 years (OR, 3.40; 95% CI, 1.97-5.87) and those known to a nephrologist for more than 3 months (OR, 6.50; 95% CI, 3.18-13.30) were more likely to receive information about conservative care. Patients with conservative care as planned initial treatment were more likely to be older than 65 years (OR, 4.71; 95% CI, 1.77-12.49) and women (OR, 2.23; 95% CI, 1.23-4.02) than those who started dialysis therapy. Those with private health insurance were less likely to forgo dialysis therapy (OR, 0.40; 95% CI, 0.17-0.98). Limitations: Cross-sectional design prohibited longer term outcome measurement. Excluded patients with stage 5 CKD managed in the community. Conclusions: 1 in 7 patients with stage 5 CKD referred to nephrologists plans not to dialyze. Comprehensive service provision with integrated palliative care needs to be improved to meet the demands of the aging population. Refereed/Peer-reviewed

Purpose To develop more evidence-based guidelines for the frequency of patient follow-up after treatment of localized (American Joint Committee on Cancer [AJCC] stage I or II) melanoma. Methods We used data from Melanoma Institute Australia on an inception cohort of 3,081 consecutive patients first diagnosed with stage I or II melanoma between January 1985 and December 2009. Kaplan-Meier curves and Cox models were used to characterize the time course and predictors for recurrence and new primaries. We modeled the delay in diagnosis of recurrence or new primary as well as the number of monitoring visits required using two monitoring schedules: first, according to 2008 Australian and New Zealand guidelines and, second, with fewer visits, especially for those at lowest risk of recurrence. Results For every 1,000 patients beginning follow-up, 229 developed recurrence and 61 developed new primary within 10 years. There was only a small difference in modeled delay in diagnosis (extra 44.9 and 9.6 patients per 1,000 for recurrence and new primary, respectively, with delay greater than 2 months) using a schedule that requires far fewer visits (3,000 fewer visits per 1,000 patients) than recommended by current guidelines. AJCC substage was the most important predictor of recurrence, whereas age and date of primary diagnosis were important predictors of developing new primary. Conclusion By providing less intensive monitoring, more efficient follow-up strategies are possible. Fewer visits with a more focused approach may address the needs of patients and clinicians to detect recurrent or new melanoma.