Evidence map›Paper›PMID 32605576›Full record

ArticleTrials2020

The Melanoma Genomics Managing Your Risk Study randomised controlled trial: statistical analysis plan.

Serigne N Lo, Amelia K Smit, David Espinoza, Anne E Cust, Managing Your Risk Study Group

Open access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
0.8field-weighted citation impact, top 25% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 6 citations in OpenAlex.

  1. Impact of personal genomic risk information on melanoma prevention behaviors and psychological outcomes: a randomized controlled trial.Genetics in medicine : official journal of the American College of Medical Genetics · 2021
    Trial
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 1 institution in 1 country.

Serigne N LoThe University of Sydney, Melanoma Institute Australia, Sydney, NSW, Australia.
Amelia K SmitThe University of Sydney, Melanoma Institute Australia, Sydney, NSW, Australia.
David EspinozaThe University of Sydney, NHMRC Clinical Trials Centre, Sydney, NSW, Australia.
Anne E CustThe University of Sydney, Melanoma Institute Australia, Sydney, NSW, Australia. anne.cust@sydney.edu.au.
Managing Your Risk Study Group
The University of Sydney · AU

Funding

Melanoma Institute Australia Postgraduate Research ScholarshipNational Health and Medical Research Council 112822National Health and Medical Research Council 1147843The University of Sydney Research Training Program (RTP) Stipend Scholarship and a Merit Top Up Scholarship
6 · The paper itself

Abstract

backgroundThe 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.

objectiveTo publish the pre-determined statistical analysis plan (SAP) before database lock and the start of analysis.

methodsThis 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.

resultsThis SAP is consistent with best practice and should enable transparent reporting.

conclusionThis 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 registrationProspectively registered with the Australian New Zealand Clinical Trials Registry, ID: ACTR N12617000691347 . Registered on 15 May 2017.

Indexed as

Data Interpretation, StatisticalGenetic Predisposition to DiseaseAustraliaCost-Benefit AnalysisEnvironmental ExposureGenetic TestingGenomicsHealth BehaviorHumansMelanomaRandomized Controlled Trials as TopicRisk AssessmentSkin NeoplasmsUltraviolet RaysBehavioursBioethicsEarly detectionGenomic riskMelanomaPreventionPsycho-oncologyRandomised controlled trialSun exposureSun protection

Identifiers

PMID32605576
PMCPMC7329549
OpenAlexW3040064098

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.