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Comparison · NCT02721082-deaths

Opt Out vs Opt In: deaths from any cause

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

2 sourcestrial-comparisons-2026-03-23-0.1.0

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ConductScience Library. Opt Out vs Opt In: deaths from any cause. Trial comparisons, record NCT02721082-deaths. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02721082-deaths

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 10.04120.02850.0593wilson
Risk in group 20.05510.03550.0844wilson
Risk difference, group 1 minus group 2-0.0139-0.04580.0128newcombe hybrid score
Risk ratio, group 1 over group 20.7480.4221.33log
Odds ratio, group 1 over group 20.7380.4041.35log
Number needed to treat, for one fewer death from any cause on Opt Out than on Opt In72.2from the risk difference intervalthe interval includes no difference

Groups2

Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Opt Out
Participants in this arm will be first enrolled to receive cessation treatment and will only not receive it by opting out. Participant will receive a Opt Out treatment program. Participants will receive counseling and nicotine replacement therapy.~Opt Out Treatment Program: Tobacco Treatment (UKanQuit) staff will complete a treatment plan for all participants.~Nicotine Replacement Therapy: Unless they Opt Out all participants will be provided with a 14 day supply of the nicotine patch and nicotine mini-lozenges or nicotine gum, depending on study related criteria.
27655EG000
Group 2Opt In
Traditional approach to tobacco treatment program. Participants must first indicate they are ready to quit smoking by opting in to receive Opt In treatment program.~Opt In Treatment Program: Tobacco Treatment (UKanQuit) staff will complete a treatment plan for participant's who are ready to quit smoking. For patient's not ready to quit, motivational counseling will be provided to participants based on principles of Motivational Interviewing.~Nicotine Replacement Therapy: Participants ready to quit will be provided with a 14 day supply of the nicotine patch and nicotine mini-lozenges or nicotine gum, depending on study related criteria.
19345EG001

Harm

What it counts
Total, all-cause mortality
Time frame
Adverse event data were collect for 6 months following randomization

Source ClinicalTrials.gov

Trial

Title
Changing the Default for Tobacco Treatment
NCT number
NCT02721082
Phases
PHASE4
Conditions
Tobacco Use Cessation
Interventions
Opt Out Treatment Program, Nicotine Replacement Therapy, Opt In Treatment Program, Nicotine Replacement Therapy
Lead sponsor
University of Kansas Medical Center
Results first posted
2022-12-01

Source ClinicalTrials.gov

Source

Release
trial-comparisons-2026-03-23-0.1.0
Release manifest SHA-256
f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
AACT copy
2026-03-23
Tables read
outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet

Source ClinicalTrials.gov

Sources 2

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.

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