Montané Eva, Vallano Antoni, Vidal Xavier, Aguilera Cristina, Laporte Joan-Ramon
Fundació Institut Català de Farmacologia, Clinical Pharmacology Service, Hospital Universitari Vall d'Hebron, Pg Vall d'Hebron, no 119-129, 08035 Barcelona, Universitat Autònoma de Barcelona, Spain.
BMC Clin Pharmacol. 2010 Jan 12;10:2. doi: 10.1186/1472-6904-10-2.
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.
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.
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).
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.
已有多项关于创伤或骨科手术后疼痛（TOS）的镇痛药随机临床试验（RCT）发表，但尚无研究评估这些报告的质量。我们旨在检验TOS术后疼痛的镇痛药RCT报告质量。
从电子数据库中系统检索评估TOS术后疼痛的镇痛药RCT报告。使用CONSORT清单（评分范围0至22）评估报告质量。评分小于或等于12分时认为质量较差。记录发表年份和期刊影响因子。
共确定92篇RCT报告，69篇（75%）在CONSORT清单中的得分小于或等于12分（范围5至17）。所有报告的平均（标准差）CONSORT评分为10.6（2.7）。缺失的CONSORT项目包括主要和次要结局指标（11%）、具体目标和假设定义（12%）、样本量计算（12%）、定义招募期的日期（12%）、研究结果外部有效性的讨论（14%）、分配序列产生（24%）以及对结果潜在偏倚或不精确性的解释（25%）。CONSORT评分随时间有小幅改善（r = 0.62；p < 0.001），且与期刊影响因子有关（r = 0.30；p < 0.001）。
TOS术后镇痛药RCT报告质量较差。未来几年应根据方法学标准清单改进这些RCT的报告。
