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1. jamanetwork.com › journals › jamaInterpreting the Results of Intention-to-Treat, Per-Protocol ...

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   Interpreting the Results of Intention-to-Treat, Per-Protocol, and As-Treated Analyses of Clinical Trials | Research, Methods, Statistics | JAMA | JAMA Network. JAMA Guide to Statistics and Methods. August 3, 2021. Interpreting the Results of Intention-to-Treat, Per-Protocol, and As-Treated Analyses of Clinical Trials.

   • Original Investigation Effect of Catheter Ablation vs Antiarrhythmic Drugs on Mortality, Stroke, Bleeding, and Cardiac Arrest in Af

     The improvement in mortality or CV hospitalization outcomes,...

   • The Intention-to-Treat Principle

     The intention-to-treat (ITT) principle is a cornerstone in...

   • Do Not Abandon Significance

     For decades, statisticians and clinicians have debated the...

2. www.ncbi.nlm.nih.gov › pmc › articlesIntention-to-treat versus as-treated versus per-protocol ...

   www.ncbi.nlm.nih.gov › pmc › articles

   Nov 14, 2023 · Keywords: Data analysis, Intention to treat analysis, Intervention study, Randomized controlled trial, Statistics, Treatment outcome Gap between real and ideal A randomized controlled trial (RCT) is an experimental research design in which researchers introduce one or more interventions and subsequently observe the outcomes [ 1 ].

   • Author: EunJin Ahn, Hyun Kang
   • Published: 2023/12

   • DOI: 10.4097/kja.23278

3. People also ask

   What happens if an intention-to-treat analysis fails to reach statistical significance?

   • When an intention-to-treat analysis fails to reach statistical significance, arguments are advanced that nonadherence and treatment crossovers may have masked real treatment effects and that as-treated or per-protocol analyses may get closer to the truth.

   The Primary Outcome Fails — What Next? | NEJM

   www.nejm.org/doi/full/10.1056/NEJMra1510064

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   What should be considered when analyzing clinical trials?

   • The reasons for exclusion should be noted and the effects of all losses on the main analyses should be carefully considered. When both the ITT principle and the PP approach are used for analyzing the results of clinical trials and lead to similar conclusions, confidence in the trial results increases.

   Intention-to-treat versus as-treated versus per-protocol approaches to

   www.ncbi.nlm.nih.gov/pmc/articles/PMC10718629/

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   Why is an ITT analysis used in non-inferiority trials?

   • When the primary objective of a trial is to evaluate non-inferiority, an ITT analysis skews the data towards potentially showing non-inferiority. Because of this it is typical in non-inferiority trials to use an as-treated analysis as the primary analysis [ 39, 40 ].

   Clinical trials: design, endpoints and interpretation of outcomes

   www.nature.com/articles/s41409-021-01542-0

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   Why is regression analysis important in randomized trials?

   • Regression analyses are an important element of randomized trials analyses even when the primary analysis is not based on regression models. Regression models provide estimates of effect sizes (e.g., odds ratios or hazard ratios), which are important when interpreting the results of trials.

   Clinical trials: design, endpoints and interpretation of outcomes

   www.nature.com/articles/s41409-021-01542-0

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4. jamanetwork.com › collections › 44042JAMA Guide to Statistics and Methods | JAMA Network

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   This JAMA Guide to Statistics and Methods describes how intention-to-treat, per-protocol, and as-treated approaches to analysis differ with regard to the patient population and treatment assignments and their implications for interpretation of treatment effects in clinical trials.

5. www.ncbi.nlm.nih.gov › pmc › articlesInterpreting the Results of Intention-to-Treat, Per-Protocol ...

   www.ncbi.nlm.nih.gov › pmc › articles

   Aug 8, 2021 · The PP analysis suggested a potentially larger, but still not statistically significant, effect of catheter ablation (HR, 0.74 [95% CI, 0.54-1.01]). In the AT analysis, the resulting estimate of benefit of undergoing ablation reached statistical significance (HR, 0.67 [95% CI, 0.50-0.89]).

6. www.nejm.org › doi › fullThe Primary Outcome Fails — What Next? | New England Journal ...

   www.nejm.org › doi › full

   Sep 1, 2016 · When an intention-to-treat analysis fails to reach statistical significance, arguments are advanced that nonadherence and treatment crossovers may have masked real treatment effects...

   • Author: Stuart J. Pocock, Gregg W. Stone

   • Publish Year: 2016

7. www.nature.com › articles › s41409/021/01542-0Clinical trials: design, endpoints and interpretation of outcomes

   www.nature.com › articles › s41409/021/01542-0

   Jan 7, 2022 · Because of this it is typical in non-inferiority trials to use an as-treated analysis as the primary analysis [39, 40]. A critical element of a non-inferiority design is the non-inferiority margin ...

8. link.springer.com › referenceworkentry › 10Intention to Treat and Alternative Approaches | SpringerLink

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   Jul 20, 2022 · An as-treated (AT) analysis assigns subjects or patients to the treatment-taken group regardless of the randomized assignment. As Ellenberg ( 1996 ) points out, these AT analyses assign subjects to groups based on their compliance in the randomized trial.