报告创伤或骨科手术后镇痛药的随机临床试验是不充分的:一项系统综述。

Eva Montané, Antoni Vallano, Xavier Vidal, Cristina Aguilera, Joan-Ramon Laporte
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引用次数: 34

摘要

背景:已经发表了几项关于创伤或骨科手术(TOS)术后镇痛的随机临床试验(RCTs),但没有研究评估这些报告的质量。我们的目的是检查关于TOS术后镇痛药的随机对照试验报告的质量。方法:系统检索电子数据库中评价TOS术后镇痛药物的随机对照试验报告。使用CONSORT检查表评估报告的质量(评分范围从0到22)。当得分为12分或更低时,则认为质量较差。记录期刊的出版年份和影响因子。结果:共纳入92份rct报告,其中69份(75%)在CONSORT检查表中得分为12分及以下(范围5-17)。所有报告的CONSORT平均(SD)评分为10.6(2.7)。缺失的CONSORT项目包括主要和次要结果测量(11%)、特定目标和假设定义(12%)、样本量计算(12%)、确定招募期的日期(12%)、研究结果外部效度的讨论(14%)、分配序列生成(24%)以及对潜在偏差或结果不精确的解释(25%)。随时间推移,CONSORT评分略有改善(r = 0.62;P < 0.001),并与期刊影响因子有关(r = 0.30;P < 0.001)。结论:TOS术后镇痛药的rct报告质量较差。这些随机对照试验的报告应在未来几年内根据方法学标准清单进行改进。
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Reporting randomised clinical trials of analgesics after traumatic or orthopaedic surgery is inadequate: a systematic review.

Background: Several randomised clinical trials (RCTs) of analgesics in postoperative pain after traumatic or orthopaedic surgery (TOS) have been published, but no studies have assessed the quality of these reports. We aimed to examine the quality of reporting RCTs on analgesics for postoperative pain after TOS.

Methods: Reports of RCTs assessing analgesics in postoperative pain after TOS were systematically searched from electronic databases. The quality of reports was assessed using the CONSORT checklist (scoring range from 0 to 22). The quality was considered poor when scoring was 12 or lesser. The publication year and the impact factor of journals were recorded.

Results: A total of 92 reports of RCTs were identified and 69 (75%) scored 12 or lesser in CONSORT checklist (range 5-17). The mean (SD) CONSORT score of all reports was 10.6 (2.7). Missing CONSORT items included primary and secondary outcome measures (11%), the specific objectives and hypothesis definition (12%), the sample size calculation (12%), the dates defining the periods of recruitment (12%), the discussion of external validity of findings (14%), the allocation sequence generation (24%), and the interpretation of potential bias or imprecision of results (25%). There was a little improvement in CONSORT scores over time (r = 0.62; p < 0.001) and with impact factor of journals (r = 0.30; p < 0.001).

Conclusion: Quality of reporting RCTs on analgesics after TOS is poor. Reporting of those RCTs should be improved according to methodological standard checklists in the next years.

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