4 results on '"Smit, Amelia K."'
Search Results
2. Translating melanoma genomic risk information into prevention and early detection strategies: behavioural, psychosocial, ethical and implementation considerations
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Smit, Amelia K
- Subjects
Prevention ,Population ,Early detection ,Genomics ,Melanoma ,Risk communication - Abstract
Melanoma, the most life threatening form of skin cancer, is associated with significant morbidity and mortality. However, more than 80% of melanoma diagnoses could be prevented through reduced sun exposure and improved sun protection. Early detection through skin examination increases the likelihood of identifying melanoma at an early stage, when disease prognosis is better. But prevention and early detection behaviours are sub-optimal in Australia. Further improvements to strategies that encourage these behaviours are required. A novel approach is to personalise prevention and early detection strategies by taking into account a range of factors, including personal genomic (polygenic) risk, for individual risk assessment, and the provision of risk-specific (risk-stratified) recommendations. For melanoma, common genomic variants individually have small to moderate effect sizes for risk, and collectively have been shown to improve risk prediction models. Melanoma genomic risk variants also have a wide distribution, which would enable the stratification of risk in the wider population. There are several potential cross-cutting implications of personalising melanoma prevention and early detection strategies for the otherwise healthy population, which relate to individuals, families, ethical and implementation considerations. However, the evidence base for these implications is poor, and considerations of benefits and drawbacks are underdeveloped. This PhD thesis addresses major gaps in research by generating novel, mixed-methods (qualitative and quantitative) evidence on key implications of translating melanoma genomic risk information into personalised prevention and early detection. It includes evidence on individual impacts, communication with family, friends and health professionals, ethical and implementation considerations. These findings will inform future research and policy on personalised prevention and early detection efforts, such as risk-stratified screening.
- Published
- 2020
3. The Melanoma Genomics Managing Your Risk Study randomised controlled trial: statistical analysis plan.
- Author
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Lo, Serigne N., Smit, Amelia K., Espinoza, David, Cust, Anne E., on behalf of the Managing Your Risk Study Group, Newson, Ainsley J., Morton, Rachael L., Kimlin, Michael, Keogh, Louise, Law, Matthew H., Kirk, Judy, Dobbinson, Suzanne J., Kanetsky, Peter A., Mann, Graham J., Dawkins, Hugh, Savard, Jacqueline, Dunlop, Kate, Trevena, Lyndal, Jenkins, Mark, and Allen, Martin
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ULTRAVIOLET radiation , *STATISTICS , *CLINICAL trial registries , *GENOMICS , *MELANOMA , *PHARMACOGENOMICS , *BRAF genes , *ENVIRONMENTAL exposure prevention , *CLINICAL trials , *GENETIC testing , *SKIN tumors , *RISK assessment , *DISEASE susceptibility , *HEALTH behavior , *COST effectiveness , *RESEARCH funding , *DATA analysis - Abstract
Background: The Melanoma Genomics Managing Your Risk Study is a randomised controlled trial that aims to evaluate the efficacy of providing information on personal genomic risk of melanoma in reducing ultraviolet radiation (UV) exposure, stratified by traditional risk group (low or high phenotypic risk) in the general population. The primary outcome is objectively measured total daily Standard Erythemal Doses at 12 months. Secondary outcomes include UV exposure at specific time periods, self-reported sun protection and skin-examination behaviours, psychosocial outcomes, and ethical considerations surrounding offering genomic testing at a population level. A within-trial and modelled economic evaluation will be undertaken from an Australian health system perspective to assess the cost-effectiveness of the intervention.Objective: To publish the pre-determined statistical analysis plan (SAP) before database lock and the start of analysis.Methods: This SAP describes the data synthesis, analysis principles and statistical procedures for analysing the outcomes from this trial. The SAP was approved after closure of recruitment and before completion of patient follow-up. It outlines the planned primary analyses and a range of subgroup and sensitivity analyses. Health economic outcomes are not included in this plan but will be analysed separately. The SAP will be adhered to for the final data analysis of this trial to avoid potential analysis bias that may arise from knowledge of the outcome data.Results: This SAP is consistent with best practice and should enable transparent reporting.Conclusion: This SAP has been developed for the Melanoma Genomics Managing Your Risk Study and will be followed to ensure high-quality standards of internal validity and to minimise analysis bias.Trial Registration: Prospectively registered with the Australian New Zealand Clinical Trials Registry, ID: ACTR N12617000691347 . Registered on 15 May 2017. [ABSTRACT FROM AUTHOR]- Published
- 2020
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4. The melanoma genomics managing your risk study: A protocol for a randomized controlled trial evaluating the impact of personal genomic risk information on skin cancer prevention behaviors.
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Smit, Amelia K., Newson, Ainsley J., Morton, Rachael L., Kimlin, Michael, Keogh, Louise, Law, Matthew H., Kirk, Judy, Dobbinson, Suzanne, Kanetsky, Peter A., Fenton, Georgina, Allen, Martin, Butow, Phyllis, Dunlop, Kate, Trevena, Lyndal, Lo, Serigne, Savard, Jacqueline, Dawkins, Hugh, Wordsworth, Sarah, Jenkins, Mark, and Mann, Graham J.
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MELANOMA , *RANDOMIZED controlled trials , *CANCER prevention , *MELANOMA diagnosis , *PHYSIOLOGICAL effects of ultraviolet radiation , *GENETICS - Abstract
Background Reducing ultraviolet radiation (UV) exposure and improving early detection may reduce melanoma incidence, mortality and health system costs. This study aims to evaluate the efficacy and cost-effectiveness of providing information on personal genomic risk of melanoma in reducing UV exposure at 12 months, according to low and high traditional risk. Methods In this randomized controlled trial, participants (target sample = 892) will be recruited from the general population, and randomized (1:1 ratio, intervention versus control). Intervention arm participants provide a saliva sample, receive personalized melanoma genomic risk information, a genetic counselor phone call, and an educational booklet on melanoma prevention. Control arm participants receive only the educational booklet. Eligible participants are aged 18–69 years, have European ancestry and no personal history of melanoma. All participants will complete a questionnaire and wear a UV dosimeter to objectively measure their sun exposure at baseline, 1- and 12-month time-points, except 1-month UV dosimetry will be limited to ~250 participants. The primary outcome is total daily Standard Erythemal Doses at 12 months. Secondary outcomes include objectively measured UV exposure for specific time periods (e.g. midday hours), self-reported sun protection and skin-examination behaviors, psycho-social outcomes, and ethical considerations surrounding offering genomic testing at a population level. A within-trial and modelled economic evaluation will be undertaken from an Australian health system perspective to assess the intervention costs and outcomes. Discussion This trial will inform the clinical and personal utility of introducing genomic testing into the health system for melanoma prevention and early detection at a population-level. Trial registration. Australian New Zealand Clinical Trials Registry ACTRN12617000691347. [ABSTRACT FROM AUTHOR]
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- 2018
- Full Text
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