[对发表于家庭医学期刊的临床试验的方法学和伦理质量评估]

[Assessment of the methodological and ethical quality of clinical trials published in family medicine journals].

作者信息

Castaño-García Alberto, Guillén-Grima Francisco, León-Sanz Pilar

机构信息

Centro de Salud de Corella, Servicio Navarro de Salud, Corella, Navarra.

Servicio de Medicina Preventiva, Clínica Universitaria de Navarra, Pamplona, Navarra; Instituto de Investigación Sanitaria de Navarra (IdiSNA), Pamplona, Navarra.

出版信息

Gac Med Mex. 2018;154(1):92-104. doi: 10.24875/GMM.17002699.

DOI:10.24875/GMM.17002699

PMID:29420528

Abstract

OBJECTIVE

To evaluate some methodological and ethical quality variables of clinical trials (CTs) published in 10 family medicine journals.

METHODS

Quality descriptive study of 10 family medicine journals including CTs in humans published since 2010 to 2013. We obtained 141 CT and 2447 were excluded.

RESULTS

CTs parallels controlled in 92.9% (95% confidence interval [95% CI]: 92.0-93.9). Masked randomization in 72.3% (95% CI: 71.7-73.1), decentralized in 51.8% (95% CI: 51.4-52.4) and using as control an active treatment in 82.2% (95% CI: 81.5-83.1). Wrote informed consent in 48.9% (95% CI: 48.5-49.5) and it was not withdrawn in 56.0% of cases (95% CI: 55.5-56.7). Approval by clinical research ethics committee (CREC) in 134, and there was no conflict of interest in 117 CTs. Average κ was 0.96 (95% CI: 0.93-0.99).

CONCLUSIONS

We observe an increase in some quality variables like masked randomization (19.6%) and approval by CREC (75%) post CONSORT, in CTs published in 10 family medicine journals (2010-2013).

摘要

目的

评估在10种家庭医学期刊上发表的临床试验（CTs）的一些方法学和伦理质量变量。

方法

对10种家庭医学期刊进行质量描述性研究，包括2010年至2013年发表的人体CTs。我们获取了141项CTs，排除了2447项。

结果

CTs采用平行对照的占92.9%（95%置信区间[95%CI]：92.0 - 93.9）。采用盲法随机分组的占72.3%（95%CI：71.7 - 73.1），采用分散式的占51.8%（95%CI：51.4 - 52.4），使用活性治疗作为对照的占82.2%（95%CI：81.5 - 83.1）。撰写知情同意书的占48.9%（95%CI：48.5 - 49.5），且在56.0%的病例中未撤回（95%CI：55.5 - 56.7）。134项获得临床研究伦理委员会（CREC）批准，117项CTs不存在利益冲突。平均κ值为0.96（95%CI：0.93 - 0.99）。