Evidence map›Paper›PMID 30461608›Full record

ArticleMedicine2018

Improve the ethical review of clinical trials on traditional medicine: A cross-sectional study of clinical trial registration, ethical review, and informed consent in clinical trials of Traditional Chinese Medicine.

Hongjie Zhao, Junhua Zhang, Fengwen Yang, Lizi Tan

Abstract read
In one paragraph

Article in Medicine, 2018. 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. Article
  2. Article
  3. Article
  4. Article
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

4 authors.

Hongjie ZhaoEvidence-Based Medicine Center.
Junhua ZhangEvidence-Based Medicine Center.
Fengwen YangEvidence-Based Medicine Center.
Lizi TanTianjin University of Traditional Chinese Medicine, Tianjin, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Recently, there is an increasing number of clinical trials on Traditional Chinese medicine (TCM) published, but the implementation of Clinical Trial Registration (CTR), Ethical Review (ER), and Informed Consent (IC) in clinical trials of TCM is unclear. This study aims to investigate the status of CTR, ER, and IC in clinical trials of TCM.Clinical trials of TCM published in 10 high-quality Chinese journals in 2016 were selected as a sample. Information of clinical trial registration, ethical review, and informed consent of clinical trials was extracted for analysis. Two authors independently screened the literature and extracted the relevant information.A total of 659 clinical trials met the criteria and were included for analysis. Only 9 clinical trials reported information of clinical trial registration (1.4%). The number for ethical review and informed consent were 156 (23.7%) and 502 (76.2%).Trial registration, protocol approval, and informed consent were not well executed. Especially registration and ethical review of clinical trials in TCM should be carefully concerned by researchers, clinicians, and journal editors. Training on methodology of clinical trial should be strengthened.

Indexed as

Ethical ReviewInformed ConsentRegistriesAccess to InformationClinical Trials as TopicCross-Sectional StudiesHumansMedicine, Chinese TraditionalQuality ImprovementResearch Support as Topic

Identifiers

PMID30461608
PMCPMC6392775

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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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.