Evidence map›Paper›PMID 28900858›Full record

ReviewAdvances in therapy2017

Methodological Aspects in Studies Based on Clinical Routine Data.

Lieven Nils Kennes

Abstract readReview
In one paragraph

Review in Advances in therapy, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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

4 citing papers in PubMed.

  1. Trial
  2. Article
  3. Article
  4. Tapentadol: an overview of the safety profile.Journal of pain research · 2019
    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

1 author.

Lieven Nils KennesDepartment of Economics and Business Administration, University of Applied Sciences Stralsund, Stralsund, Germany. lieven.kennes@hochschule-stralsund.de.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Randomized controlled clinical trials are regarded as the gold standard for comparing different clinical interventions, but generally their conduct is operationally cumbersome, time-consuming, and expensive. Studies and investigations based on clinical routine data on the contrary utilize existing data acquired under real-life conditions and are increasingly popular among practitioners. In this paper, methodological aspects of studies based on clinical routine data are discussed. Important limitations and considerations as well as unique strengths of these types of studies are indicated and exemplarily demonstrated in a recent real-case study based on clinical routine data. In addition two simulation studies reveal the impact of bias in studies based on clinical routine data on the type I error rate and false decision rate in favor of the inferior intervention. It is concluded that correctly analyzing clinical routine data yields a valuable addition to clinical research; however, as a result of a lack of statistical foundation, internal validity, and comparability, generalizing results and inferring properties derived from clinical routine data to all patients of interest has to be considered with extreme caution.

fundingGrünenthal GmbH.

Indexed as

Clinical ProtocolsBiomedical ResearchData CollectionFemaleHumansResearch DesignBiasBlindingClinical routine dataInternal validityRandomization

Identifiers

PMID28900858
PMCPMC5656724

What OpenQuestion 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 OpenQuestion graph.