Jokstad Asbjørn, Esposito Marco, Coulthard Paul, Worthington Helen V
Institute of Clinical Dentistry, Faculty of Dentistry, University of Oslo, PO Box 1109 Blindern, N-0317 Oslo, Norway.
Int J Prosthodont. 2002 May-Jun;15(3):230-42.
This article evaluates the reporting of randomized controlled trials (RCT) in prosthodontics, excluding endosseous implant-based prosthetics.
Reports of RCTs published to the end of 2000 in any language were identified using a multilayered search strategy. The Cochrane Oral Health Group specialized register, Medline, and personal libraries were searched. Three researchers appraised the articles independently using guidelines following Jadad and CONSORT, complemented with an evaluation of the appropriateness of the reported statistics.
Ninety-two reports of RCTs were evaluated, covering a wide spectrum of study hypotheses, topics, and issues within various prosthodontic domains. The interrater agreements on appraisal criteria were relatively high, with median kappa values ranging between 0.65 and 0.79. The reports were in general of poor methodologic quality. Randomization and procedures for concealment allocation were not described in 70% of the articles. The methods used to generate the random allocation sequence were not mentioned in 82%. The methods used to implement the random allocation sequence, clarifying whether it was concealed until all interventions were assigned, was not mentioned in 94%. Reporting who generated allocation sequence, who enrolled patients, and who assigned participants to groups was not reported in 7%. Reasons for withdrawals were not given in 23% of the reports. No attempt at blinding was reported in 72%. Statistical analysis was not described in 6% of the papers, while these analyses were assessed as appropriate for 75%, unclear in 12%, and inappropriate in 7%.
Few RCTs in prosthodontics are reported in accordance with contemporary guidelines for adequate reporting of trials.
本文评估口腔修复学中随机对照试验（RCT）的报告情况，但不包括基于骨内种植体的修复学。
采用多层搜索策略识别截至2000年底以任何语言发表的RCT报告。检索了Cochrane口腔健康小组专业注册库、Medline和个人图书馆。三名研究人员按照Jadad和CONSORT指南独立评估文章，并对报告统计数据的适当性进行评估。
评估了92篇RCT报告，涵盖了各种口腔修复领域的广泛研究假设、主题和问题。评估标准的评分者间一致性相对较高，中位数kappa值在0.65至0.79之间。这些报告的方法学质量总体较差。70%的文章未描述随机化和隐藏分配程序。82%的文章未提及用于生成随机分配序列的方法。94%的文章未提及用于实施随机分配序列的方法，即未说明在所有干预分配之前是否隐藏该序列。7%的文章未报告谁生成分配序列、谁招募患者以及谁将参与者分配到各组。23%的报告未给出退出的原因。72%的文章未报告任何盲法尝试。6%的论文未描述统计分析，而这些分析被评估为适当的占75%，不清楚的占12%，不适当的占7%。
口腔修复学中很少有RCT按照当代充分报告试验的指南进行报告。
