Evidence map›Paper›PMID 17906335›Full record

SynthesisSchizophrenia bulletin2008

A composite approach that includes dropout rates when analyzing efficacy data in clinical trials of antipsychotic medications.

Jonathan Rabinowitz, Ori Davidov

Abstract readSystematic Review
In one paragraph

Synthesis in Schizophrenia bulletin, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–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

3 citing papers in PubMed.

  1. Article
  2. Article
  3. Review
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.

Jonathan RabinowitzBar Ilan University, Ramat Gan, Israel. jr827@columbia.edu
Ori Davidov

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundOften, outcomes in clinical trials of antipsychotic medications are examined using last observation carried forward (LOCF). One limitation of LOCF and other common approaches is that they overlook the meaning underpinning trial completion and noncompletion. Noncompletion often relates to lack of drug tolerability. Because long-term treatment is often indicated, noncompletion is an important outcome. An alternative approach is to test the composite hypothesis of the difference between (a) completion rates and (b) efficacy of complete cases. Studies to date have not applied this relatively new method.

objectiveTo illustrate the composite approach, we applied it to a systematic review of studies and compared the results with the reported LOCF analysis.

methodsA systematic search of the Schizophrenia Module of the Cochrane Library and Medline was conducted that identified 127 relevant randomized clinical trials of antipsychotic medications conducted since 1995. Extracted from study reports were the P values of a difference in dropout and the P value of a difference in improvement among complete cases. These P values were combined using standard approaches.

resultsWe identified 11 trials with 5339 participants that provided the necessary information to adequately apply the composite approach. In 2 trials, (18.2%) in which the LOCF results were not significant, the composite results were significant.

conclusionsThe composite approach was more sensitive to change than LOCF and conceptually answers a more relevant question. It is likely that applying the composite approach would change how results of many trials are interpreted.

Indexed as

Antipsychotic AgentsBiasData CollectionHumansPatient DropoutsRandomized Controlled Trials as TopicResearch DesignSchizophreniaTreatment OutcomeAntipsychotic Agents

Identifiers

PMID17906335
PMCPMC2632491

What OpenQuestion holds

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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.