What is worse? The Per-Protocol PP principle. Usually, this applies to patients fulfilling any of the following criteria:. Errot type I and II. To answer this, consider the essential difference between the two cases: Case A means that a statistically proven result is actually wrong — a result that might cause dangerous effects. What is the consequence for the choice of a patient analysis set? Sign up now! More information. By Dr.
About the Author: Dr. Michael Obermeier. Related Posts. June 15th, June 5th, May 19th, May 27th, September 20th, Bahnson, MD; Jeanne E. Poole, MD; Peter A. Noseworthy, MD; Yves D.
Kowey, MD; Gerald V. Naccarelli, MD; James A. Reiffel, MD; Jonathan P. Silverstein, MS; Hussein R. Access through your institution. Add or change institution. Save Preferences. This may make the treatment look better than it actually is Exclusion of participants in one or both groups, particularly if their number is large, may lead to a significant reduction in sample size and hence in study power Exclusions can introduce a bias. Often the decision to exclude a particular participant is controlled, at least to some extent, by the investigator, who may be tempted to exclude patients who are not doing well in a particular arm The purpose of a trial is to assess the proportion of persons in a group who may be expected to benefit from a particular treatment.
Conflicts of interest There are no conflicts of interest. Gupta SK. Intention-to-treat concept: A review. Intention to treat in clinical trials. In: Peace KE, editor. Statistical Issues in Drug Research and Development. New York: Marcel Dekker; PLoS Med.
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Guideline on the evaluation of medicinal products indicated for treatment of bacterial infections. Methodological and reporting quality of non-inferiority randomized controlled trials comparing antibiotic therapies: a systematic review. Clin Infect Dis. Ann Intern Med. Food and Drug Administration. Accessed 20 Mar Agresti A, Caffo B. Simple and effective confidence intervals for proportions and differences of proportions result from adding two successes and two failures.
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ADB and GT performed the analysis. ADB wrote a first draft of the manuscript. All authors reviewed and revised the manuscript. All authors approved the final manuscript to be submitted. Correspondence to Anthony D. Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material.
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Reprints and Permissions. Bai, A. Intention-to-treat analysis may be more conservative than per protocol analysis in antibiotic non-inferiority trials: a systematic review. Download citation. Received : 25 September Accepted : 26 March Published : 19 April Anyone you share the following link with will be able to read this content:.
Sorry, a shareable link is not currently available for this article. Provided by the Springer Nature SharedIt content-sharing initiative. Skip to main content. Search all BMC articles Search. Download PDF. Research article Open Access Published: 19 April Intention-to-treat analysis may be more conservative than per protocol analysis in antibiotic non-inferiority trials: a systematic review Anthony D.
Komorowski 3 , Carson K. Lo 1 , Pranav Tandon 4 , Xena X. Abstract Background In non-inferiority trials, there is a concern that intention-to-treat ITT analysis, by including participants who did not receive the planned interventions, may bias towards making the treatment and control arms look similar and lead to mistaken claims of non-inferiority. Methods In a secondary analysis of a systematic review, we included non-inferiority trials that compared different antibiotic regimens, used absolute risk reduction ARR as the main outcome and reported both ITT and PP analyses.
Results The analysis included comparisons from studies. Conclusions Contrary to common belief, ITT analysis was more conservative than PP analysis in the majority of antibiotic non-inferiority trials. Data extraction Six reviewers screened abstracts after a training session to identify potentially relevant studies and extract full texts for reading. Variables collected We extracted the following data from each journal article: journal, year of study, sample size, inclusion and exclusion criteria for ITT as well as PP population, treatment of missing data, and the primary outcome including the absolute numbers successes and total number of patients in each arm and reported CI.
Primary outcome The co-primary outcomes were the point estimate and lower CI. Full size image. Results Studies included Of the antibiotic non-inferiority trials, 41 Flow diagram of study selection process. Table 1 Study characteristics Full size table.
Table 2 Risk of bias assessment Full size table. Discussion In this systematic review of antibiotic non-inferiority trials, ITT analysis was more conservative than PP analysis in the majority of cases.
Conclusions Our systematic review of antibiotic non-inferiority trials showed that ITT analysis on average produced wider CIs and was more conservative than PP analysis.
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