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中国癌症疼痛治疗随机对照试验报告质量。

Quality of reporting in randomized controlled trials conducted in China on the treatment of cancer pain.

机构信息

Department of Oncology, First Affiliated Hospital, Guangzhou University of Chinese Medicine, Guangzhou 510405, China.

出版信息

Expert Rev Anticancer Ther. 2011 Jun;11(6):871-7. doi: 10.1586/era.10.236.

Abstract

BACKGROUND

Research in China has been rapidly gaining momentum, but as yet there is no systematic evaluation of quality of reporting in randomized controlled trials (RCTs) on the treatment of cancer pain conducted in China. Therefore, an assessment in this field is an imperative issue.

METHODS

A PubMed search of reports published between 1994 and 2009 followed by an examination and critical appraisal of reporting in RCTs on the treatment of cancer pain was conducted in China. All reports had been examined to describe their general characteristics and evaluate the quality of their reporting. Quality of reporting was assessed against a subset of criteria adapted from the Consolidated Standards of Reporting Trials (CONSORT) statement.

RESULTS

A total of 46 RCTs were included in full text. The frequency of RCTs was found to increase over time: from one (2.2%) in 1994-1997 to 28 (60.9%) in 2006-2009. There were fewer papers published in this field in foreign journals, as funding sources and opportunities for collaborative research with foreigners are still limited. Visual analogue scales were the main method of cancer pain evaluation (19 reports; 41.4%). Only 12 studies (26.1%) are deemed to have authentic randomization and 36 papers (78.3%) provided no information about blinding of either participants or investigators. In 22 papers (47.8%), there was no information about the length of time for which participants were followed. Only 15 (32.6%) of the included trials reported approval by an ethics committee and 17 (37.0%) adequately discussed informed consent.

CONCLUSION

The quality of reporting in RCTs on the treatment of cancer pain conducted in China needs to be improved. Three critical steps should be strictly conducted including randomization, blinding and follow-up. Reporting of RCTs in this field conducted in China should meet and keep up with the standards of CONSORT statement.

摘要

背景

中国的医学研究发展迅速,但目前仍缺乏对中国开展的癌症疼痛治疗的随机对照试验(RCT)报告质量的系统评价。因此,对该领域进行评估是当务之急。

方法

对 1994 年至 2009 年期间发表的报告进行 PubMed 检索,然后对中国开展的癌症疼痛治疗的 RCT 报告进行检查和批判性评估。对所有报告进行了检查,以描述其一般特征并评估其报告质量。报告质量评估采用了源自 CONSORT 声明的一组标准的子集。

结果

共纳入 46 项 RCT 全文。研究结果显示,RCT 的数量随时间推移而增加:1994-1997 年有 1 项(2.2%),2006-2009 年有 28 项(60.9%)。该领域在国外期刊上发表的论文较少,因为资金来源和与外国人合作研究的机会仍然有限。视觉模拟量表是评估癌症疼痛的主要方法(19 项研究;41.4%)。只有 12 项研究(26.1%)被认为是真实随机的,36 篇论文(78.3%)没有提供参与者或研究者盲法的信息。在 22 篇论文(47.8%)中,没有提供参与者随访时间的信息。只有 15 项(32.6%)纳入试验报告了伦理委员会的批准,17 项(37.0%)充分讨论了知情同意。

结论

中国开展的癌症疼痛治疗 RCT 的报告质量有待提高。随机化、盲法和随访这三个关键步骤应严格执行。中国开展的该领域 RCT 的报告应符合并跟上 CONSORT 声明的标准。

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