Can patient-led surveillance detect subsequent new primary or recurrent melanomas and reduce the need for routinely scheduled follow up? Statistical analysis plan for the MEL-SELF randomised controlled trial
Field | Value | Language |
dc.contributor.author | Medcalf, Ellie | |
dc.contributor.author | Taylor, Aiya | |
dc.contributor.author | Turner, Robin M | |
dc.contributor.author | Espinoza, David | |
dc.contributor.author | Bell, Katy J.L. | |
dc.date.accessioned | 2023-02-21T04:27:17Z | |
dc.date.available | 2023-02-21T04:27:17Z | |
dc.date.issued | 2022 | en_AU |
dc.identifier.uri | https://hdl.handle.net/2123/30075 | |
dc.description.abstract | 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. Objective: 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. Methods/design: 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. Results: 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. | en_AU |
dc.language.iso | en | en_AU |
dc.publisher | Elsevier | en_AU |
dc.relation.ispartof | Contemporary Clinical Trials | en_AU |
dc.rights | Creative Commons Attribution 4.0 | en_AU |
dc.subject | Statistical analysis plan | en_AU |
dc.subject | Randomised controlled trial | en_AU |
dc.subject | Melanoma | en_AU |
dc.subject | Patient-led surveillance | en_AU |
dc.title | Can patient-led surveillance detect subsequent new primary or recurrent melanomas and reduce the need for routinely scheduled follow up? Statistical analysis plan for the MEL-SELF randomised controlled trial | en_AU |
dc.type | Article | en_AU |
dc.subject.asrc | 1112 Oncology and Carcinogenesis | en_AU |
dc.subject.asrc | 1117 Public Health and Health Services | en_AU |
dc.identifier.doi | 10.1016/j.cct.2022.106761 | |
dc.type.pubtype | Author accepted manuscript | en_AU |
dc.relation.nhmrc | 1163054 | |
dc.relation.nhmrc | 1174523 | |
dc.rights.other | This research was funded in whole or part by the National Health and Medical Research Council Project (#1163054) and Investigator (#1174523) grants. For the purposes of open access, the author has applied a CC BY public copyright licence to any Author Accepted Manuscript version arising from this submission | en_AU |
usyd.faculty | SeS faculties schools::Faculty of Medicine and Health::Sydney School of Public Health | en_AU |
usyd.citation.volume | 117 | en_AU |
workflow.metadata.only | No | en_AU |
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