Evidence map›Paper›PMID 27701471›Full record

ArticlePloS one2016

Readability and Content Assessment of Informed Consent Forms for Phase II-IV Clinical Trials in China.

Gaiyan Wen, Xinchun Liu, Lihua Huang, Jingxian Shu, Nana Xu, Ruifang Chen, Zhijun Huang, Guoping Yang, Xiaomin Wang, Yuxia Xiang and 2 more

Abstract readComparative Study
PubMed Full text at PMC Publisher
In one paragraph

Article in PloS one, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing 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

11 citing papers in PubMed.

  1. Trial
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  5. 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

12 authors.

Gaiyan WenThe Ethics Committee, the 3rd Xiangya Hospital of Central South University, Changsha, Hunan, China.
Xinchun LiuClinical Pharmacology Center, the 3rd Xiangya Hospital of Central South University, Changsha, Hunan, China.
Lihua HuangCenter for Medical Experiments, the 3rd Xiangya Hospital of Central South University, Changsha, Hunan, China.
Jingxian ShuThe Ethics Committee, the 3rd Xiangya Hospital of Central South University, Changsha, Hunan, China.
Nana XuThe Ethics Committee, the 3rd Xiangya Hospital of Central South University, Changsha, Hunan, China.
Ruifang ChenClinical Pharmacology Center, the 3rd Xiangya Hospital of Central South University, Changsha, Hunan, China.
Zhijun HuangThe Ethics Committee, the 3rd Xiangya Hospital of Central South University, Changsha, Hunan, China.
Guoping YangThe Ethics Committee, the 3rd Xiangya Hospital of Central South University, Changsha, Hunan, China.
Xiaomin WangThe Ethics Committee, the 3rd Xiangya Hospital of Central South University, Changsha, Hunan, China.
Yuxia XiangClinical Pharmacology Center, the 3rd Xiangya Hospital of Central South University, Changsha, Hunan, China.
Yao LuThe Ethics Committee, the 3rd Xiangya Hospital of Central South University, Changsha, Hunan, China.
Hong YuanThe Ethics Committee, the 3rd Xiangya Hospital of Central South University, Changsha, Hunan, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo explore the readability and content integrity of informed consent forms (ICFs) used in China and to compare the quality of Chinese local ICFs with that of international ICFs.

methodsThe length, readability and content of 155 consent documents from phase II-IV drug clinical trials from the Third Xiangya Hospital Ethics Committee from November 2009 to January 2015 were evaluated. Reading difficulty was tested using a readability formula adapted for the Chinese language. An ICF checklist containing 27 required elements was successfully constructed to evaluate content integrity. The description of alternatives to participation was assessed. The quality of ICFs from different sponsorships were also compared.

resultsAmong the 155 evaluable trials, the ICFs had a median length of 5286 words, corresponding to 7 pages. The median readability score was 4.31 (4.02-4.41), with 63.9% at the 2nd level and 36.1% at the 3rd level. Five of the 27 elements were frequently neglected. The average score for the description of alternatives to participation was 1.06, and 27.7% of the ICFs did not mention any alternatives. Compared with Chinese local ICFs, international ICFs were longer, more readable and contained more of the required elements (P < 0.05).

conclusionThe ICFs used in China were difficult to read for most participants. These forms had poor description of alternatives to participation, and failed to provide a high degree of information disclosure, including an explanation of informed consent, follow-up processing of the data/sample, inclusion/exclusion criteria, double blinding, and unpredictable risks. International ICFs had better readability and content integrity than Chinese local ICFs. More efforts should thus be made to improve the quality of consent documents in China.

Indexed as

ComprehensionConsent FormsChinaClinical Trials, Phase II as TopicClinical Trials, Phase III as TopicClinical Trials, Phase IV as TopicHumansReading

Identifiers

PMID27701471
PMCPMC5049790

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.