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dc.contributor.authorMedcalf, Ellie
dc.contributor.authorTaylor, Aiya
dc.contributor.authorTurner, Robin M
dc.contributor.authorEspinoza, David
dc.contributor.authorBell, Katy J.L.
dc.date.accessioned2023-02-21T04:27:17Z
dc.date.available2023-02-21T04:27:17Z
dc.date.issued2022en_AU
dc.identifier.urihttps://hdl.handle.net/2123/30075
dc.description.abstractThe 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.isoenen_AU
dc.publisherElsevieren_AU
dc.relation.ispartofContemporary Clinical Trialsen_AU
dc.rightsCreative Commons Attribution 4.0en_AU
dc.subjectStatistical analysis planen_AU
dc.subjectRandomised controlled trialen_AU
dc.subjectMelanomaen_AU
dc.subjectPatient-led surveillanceen_AU
dc.titleCan 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 trialen_AU
dc.typeArticleen_AU
dc.subject.asrc1112 Oncology and Carcinogenesisen_AU
dc.subject.asrc1117 Public Health and Health Servicesen_AU
dc.identifier.doi10.1016/j.cct.2022.106761
dc.type.pubtypeAuthor accepted manuscripten_AU
dc.relation.nhmrc1163054
dc.relation.nhmrc1174523
dc.rights.otherThis 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 submissionen_AU
usyd.facultySeS faculties schools::Faculty of Medicine and Health::Sydney School of Public Healthen_AU
usyd.citation.volume117en_AU
workflow.metadata.onlyNoen_AU


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