Evidence map›Paper›PMID 38031328›Full record

ArticleKorean journal of anesthesiology2023

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

EunJin Ahn, Hyun Kang

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Korean journal of anesthesiology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 45 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
45citing papers in PubMed, 2 pooled it
–field-weighted citation impact
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

45 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
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  11. Testing the Efficacy of RESPONSIBLEPLAYInternational journal of environmental research and public health · 2025
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  13. Pragmatic O-Positive Whole-blood RandoMizaTion in male trauma Patients (POWeR-MTP).European journal of trauma and emergency surgery : official publication of the European Trauma Society · 2025
    Trial
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  17. Observational
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  19. BMJ open · 2026
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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

2 authors.

EunJin AhnDepartment of Anesthesiology and Pain Medicine, Chung-Ang University College of Medicine, Seoul, Korea.
Hyun KangDepartment of Anesthesiology and Pain Medicine, Chung-Ang University College of Medicine, Seoul, Korea.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Randomized controlled trials (RCTs) are considered the most rigorous study design for testing hypotheses and the gold standard for evaluating intervention effectiveness. However, RCTs are often conducted under the assumption of ideal conditions that may differ from real-world scenarios in which various issues, such as loss to follow-up, mistakes in participant enrollment or intervention, and low subject compliance or adherence, may occur. There are various group-defining strategies for analyzing RCT data, including the intention-to-treat (ITT), as-treated, and per-protocol (PP) approaches. The ITT principle involves analyzing all participants according to their initial group assignments, regardless of study completion and compliance or adherence to treatment protocols. This approach aims to replicate real-world clinical settings in which several anticipated or unexpected conditions may occur with regard to the study protocol. For the PP approach, only participants who meet the inclusion criteria, complete the interventions according to the study protocols, and have primary outcome data available are included. This approach aims to confirm treatment effects under optimal conditions. In general, the ITT principle is preferred for superiority and inequality trials, whereas the PP approach is preferred for equivalence and non-inferiority trials. However, both analytical approaches should be conducted and their results compared to determine whether significant differences exist. Overall, using both the ITT and PP approaches can provide a more complete picture of the treatment effects and ensure the reliability of the trial results.

Indexed as

Research DesignHumansIntention to Treat AnalysisTreatment OutcomeData analysisIntention to treat analysisIntervention studyRandomized controlled trialStatisticsTreatment outcome.

Identifiers

PMID38031328
PMCPMC10718629

What Socratic holds

Textmetadata
LicenceCC BY-NC
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 Socratic graph.