Evidence map›Paper›PMID 24595104›Full record

SynthesisPloS one2014

Are Japanese randomized controlled trials up to the task? A systematic review.

Daisuke Yoneoka, Akinori Hisashige, Erika Ota, Karin Miyamoto, Shuhei Nomura, Miwako Segawa, Stuart Gilmour, Kenji Shibuya

Abstract readSystematic Review
In one paragraph

Synthesis in PloS one, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. Review
  2. 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

8 authors.

Daisuke YoneokaDepartment of Global Health Policy, Graduate School of Medicine, University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan.
Akinori HisashigeDepartment of Global Health Policy, Graduate School of Medicine, University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan; Institute of Healthcare Technology Assessment, 2-24-10, Shomachi, Tokushima, Japan.
Erika OtaDepartment of Global Health Policy, Graduate School of Medicine, University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan.
Karin MiyamotoDepartment of Global Health Policy, Graduate School of Medicine, University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan.
Shuhei NomuraDepartment of Global Health Policy, Graduate School of Medicine, University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan.
Miwako SegawaDepartment of Global Health Policy, Graduate School of Medicine, University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan.
Stuart GilmourDepartment of Global Health Policy, Graduate School of Medicine, University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan.
Kenji ShibuyaDepartment of Global Health Policy, Graduate School of Medicine, University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesDespite increasing numbers of RCTs done in Japan, existing international databases fail to capture them, and detailed information on the quality of Japanese RCTs is still missing. This study assessed the characteristics and quality of Japanese RCTs and analyzed factors related to their quality.

methodsAll RCTs conducted in Japan, and published as original articles that assessed the effect of healthcare interventions on humans in 2010, were included. We excluded study protocols, conference abstracts, and comments. In addition, quasi-RCTs were excluded. Data were independently abstracted and assessed by two of the authors and disagreements were resolved by consensus. The quality of Japanese RCTs randomly sampled was assessed using the method guidelines for systematic reviews from the Cochrane Back Review Group. The factors affecting RCT quality were analyzed using a logistic regression model.

resultsA total of 1013 RCTs conducted in Japan were published in 2010. The majority was small-scale (55% of RCTs with sample size less than 50). Eighty percent of RCTs had no information on the funding source and only 8% had been registered before their implementation. RCTs not indexed in international databases were a moderate number (118 RCTs: 37.7% of non-indexed RCTs were of high quality). Surgical intervention studies for external causes of morbidity and mortality with a large sample size, trial registration and a large number of arms were most likely to be of higher quality.

conclusionDespite a considerable number of RCTs conducted in Japan, their quality is not satisfactory in some domains. On the other hand, there are high-quality, non-indexed RCTs. The full disclosure of trial information and quality control of clinical trials are urgently needed in Japan.

Indexed as

Randomized Controlled Trials as TopicHumansJapan

Identifiers

PMID24595104
PMCPMC3940821

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.