Evidence map›Paper›PMID 20547685›Full record

SynthesisBMJ (Clinical research ed.)2010

Modified intention to treat reporting in randomised controlled trials: systematic review.

Iosief Abraha, Alessandro Montedori

Registry-linked trialAbstract readSystematic Review
PubMed Full text at PMC Publisher
In one paragraph

Synthesis in BMJ (Clinical research ed.), 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03199937 (Behavioral and Neural Outcomes of a New Executive Function Treatment for Transition-age Youth With ASD), which is not on this map. Cited by 118 papers, 14 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
118citing papers in PubMed, 14 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.

NCT03199937 nacompletednot on this mapstarted 2015, after this paper: background citation

Behavioral and Neural Outcomes of a New Executive Function Treatment for Transition-age Youth With ASD

TypeinterventionalSponsorChildren's National Research InstituteRan2015 to 2019Enrolled68ConditionsAutism Spectrum DisorderArmsFlexible Futures, Current standard of care
3 · Its place in the literature

Who cites it

118 citing papers in PubMed, 14 syntheses or guidelines pooled it.

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  10. Methodological quality of behavioural weight loss studies: a systematic review.Obesity reviews : an official journal of the International Association for the Study of Obesity · 2016
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58 more citing papers are in PubMed but not listed here.

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.

Iosief AbrahaRegional Health Authority of Umbria, via Mario Angeloni 61, 06123 Perugia, Italy. iosief_a@yahoo.it
Alessandro Montedori

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo determine the incidence and characteristics of randomised controlled trials that report using the modified intention to treat approach, and how the approach is described.

designSystematic review. DATA SOURCES: PubMed, Embase, Cochrane central register of controlled trials, ISI Web of Knowledge, Ovid, HighWire Press, Science-Direct, Ingenta, Medscape, BioMed Central, Springer, and Wiley, from inception to December 2006.

main outcome measuresIncidence of trials in which use of modified intention to treat was reported, and how the approach was described (classified according to the type and number of deviations from the intention to treat approach).

results475 randomised controlled trials reported use of a modified intention to treat analysis. Of these, 76 (16%) were published in five highly cited general medical journals. The incidence of all trials that reported use of modified intention to treat published in journals indexed in Medline increased from 0.006% in 1982-6 to 0.5% in 2002-6 (P<0.001 for linear trend). When the description of the modified intention to treat was examined in each trial, 192 (40%) reported one type of deviation from the intention to treat approach, 261 (55%) reported two or more types, and 22 (5%) did not describe any type. In 266 (56%) of the trials the deviation was related to the treatment received, in 196 (41%) to a post baseline assessment, in 118 (25%) to a baseline assessment, in 108 (23%) to a target condition, and in 23 (5%) to follow-up. Post-randomisation exclusions occurred in 380 (80%) trials. The results reported by 270 of the 352 (77%) superiority trials favoured the drug under investigation. All of the 123 trials using equivalence or non-inferiority methods to investigate interventions reported results that favoured their assumptions.

conclusionsRandomised controlled trials that report using a modified intention to treat are increasingly being published in the medical literature. The descriptions of such an approach were ambiguous, and may cover any type of descriptions for exclusion, such as missing data and deviation from protocol. Explicit statements about post-randomisation exclusions should replace the ambiguous terminology of modified intention to treat.

Indexed as

Data CollectionIntention to Treat AnalysisRandomized Controlled Trials as Topic

Identifiers

PMID20547685
PMCPMC2885592

What OpenQuestion holds

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Registered trials

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.