Evidence map›Paper›PMID 33319119›Full record

ArticleContemporary clinical trials communications2020

Intention-to-treat analysis when only a baseline value is available.

Jos Wr Twisk, Judith Jm Rijnhart, Trynke Hoekstra, Noah A Schuster, Marieke M Ter Wee, Martijn W Heymans

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Article in Contemporary clinical trials communications, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 34 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
34citing papers in PubMed, 1 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

34 citing papers in PubMed, 1 synthesis or guideline pooled it.

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  11. Functional improvement by behavioural activation for depressed older adults.European psychiatry : the journal of the Association of European Psychiatrists · 2023
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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

6 authors.

Jos Wr TwiskDepartment of Epidemiology and Biostatistics, Amsterdam Public Health Research Institute, UMC Amsterdam, the Netherlands.
Judith Jm RijnhartDepartment of Epidemiology and Biostatistics, Amsterdam Public Health Research Institute, UMC Amsterdam, the Netherlands.
Trynke HoekstraDepartment of Health Science, Amsterdam Public Health Research Institute, Faculty of Science, VU University, Amsterdam, the Netherlands.
Noah A SchusterDepartment of Epidemiology and Biostatistics, Amsterdam Public Health Research Institute, UMC Amsterdam, the Netherlands.
Marieke M Ter WeeDepartment of Epidemiology and Biostatistics, Amsterdam Public Health Research Institute, UMC Amsterdam, the Netherlands.
Martijn W HeymansDepartment of Epidemiology and Biostatistics, Amsterdam Public Health Research Institute, UMC Amsterdam, the Netherlands.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesHow to perform an intention to treat (ITT) analysis when a patient has a baseline value but no follow-up measurements is problematic. The purpose of this study was to compare different methods that deal with this problem, i.e. no imputation (standard and alternative mixed model analysis), single imputation (i.e. baseline value carried forward), and multiple imputation (selective and non-selective). STUDY DESIGN AND

settingWe used a simulation study with different scenarios regarding 1) the association between missingness and the baseline value, 2) whether the patients did or did not receive the treatment, and 3) the percentage of missing data, and two real life data sets.

resultsBias and coverage were comparable between the two mixed model analyses and multiple imputation in most situations including the real life data examples. Only in the situation when the patients in the treatment group were simulated not to have received the treatment, selective imputation using this information outperformed all other methods.

conclusionsIn most situations a standard mixed model analysis without imputation is appropriate as ITT analysis. However, when patients with missing follow-up data allocated to the treatment group did not received treatment, it is advised to use selective imputation, using this information, although the results should be interpreted with caution.

Indexed as

Intention to treat analysisMixed model analysisMultiple imputationRandomised controlled trialSelective imputationSingle imputation

Identifiers

PMID33319119
PMCPMC7726664

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Registered trials

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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.