Evidence map›Paper›PMID 21842617›Full record

ReviewDialogues in clinical neuroscience2011

Effectiveness studies: advantages and disadvantages.

Hans-Jürgen Möller

Abstract readReview
In one paragraph

Review in Dialogues in clinical neuroscience, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers.

0numbers the graph read from it
0cells of the map it votes in
23citing 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

23 citing papers in PubMed.

  1. Trial
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  10. Kefir and the Gut-Skin Axis.International journal of environmental research and public health · 2022
    Article
  11. Evaluating the safety and effectiveness of PegaGenSupportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2022
    Article
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  16. Review
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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

1 author.

Hans-Jürgen MöllerDepartment of Psychiatry, Ludwig-Maximilians-University München, Munich, Germany. hans-juergen.moeller@med.uni-muenchen.de

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

In recent years, so-called "effectiveness studies," also called "real-world studies" or "pragmatic trials," have gained increasing importance in the context of evidence-based medicine. These studies follow less restrictive methodological standards than phase III studies in terms of patient selection, comedication, and other design issues, and their results should therefore be better generalizable than those of phase III trials. Effectiveness studies, like other types of phase IV studies, can therefore contribute to knowledge about medications and supply relevant information in addition to that gained from phase III trials. However, the less restrictive design and inherent methodological problems of phase IV studies have to be carefully considered. For example, the greater variance caused by the different kinds of confounders as well as problematic design issues, such as insensitive primary outcome criteria, unblinded treatment conditions, inclusion of chronic refractory patients, etc, can lead to wrong conclusions. Due to these methodological problems, effectiveness studies are on a principally lower level of evidence, adding only a complementary view to the results of phase III trials without falsifying their results.

Indexed as

Biomedical ResearchEvidence-Based MedicineAntipsychotic AgentsClinical Trials as TopicConfounding Factors, EpidemiologicHumansMental DisordersQuality of LifeTreatment OutcomeAntipsychotic Agents

Identifiers

PMID21842617
PMCPMC3181999

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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 OpenQuestion graph.