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十本印度学术牙科期刊中随机对照试验的报告质量

Quality of reporting of randomized controlled trials in ten academic Indian dental journals.

作者信息

Vundavalli Sudhakar, Naidu Guntipalli M, Bhargav A S K, Praveen B H, Pavani B, Babburi Suresh

机构信息

Department of Public Health Dentistry, Dr. SNR Siddhartha Institute of Dental Sciences, Gannavaram, Andhra Pradesh, India.

Department of Public Health Dentistry, Sri Sai College of Dental Surgery, Hyderabad, Telangana, India.

出版信息

Indian J Dent Res. 2016 Mar-Apr;27(2):116-20. doi: 10.4103/0970-9290.183132.

Abstract

BACKGROUND

Biased results from poorly reported trials can mislead decision-making in health care at all levels, from treatment decisions for the individual patient to formulation of national public health policies.

OBJECTIVE

To evaluate the quality of reporting of randomized controlled trials (RCTs) in ten Indian dental journals over the period 2011-2012.

MATERIALS AND METHODS

This study included all RCTs published as full-text articles reported in ten Indian dental journals over the period from 2011 to 2012. The relevant trials were identified by searching Medline. Hand searching of the journals was also carried out by three of the authors to check if any potential trial was missing. Each article was assessed against the Consolidated Standards of Reporting Trials criteria tool, as described by Schulz et al. (2010).

RESULTS

The mean number of criteria present per article was 12.2 (standard deviation [SD] =2.2) and only 5 of 106 articles got total possible score. Most of the articles (69%) did not mention about justification for sample size calculation, 89% of the articles did not mention about allocation concealment, 86% of the articles did not mention about funding and 63% of the articles did not mention about limitations of the study.

CONCLUSION

The quality of reporting of Randomized clinical trials in ten Indian academic journals was poor.

摘要

背景

报告不充分的试验所产生的有偏差结果可能会误导各级医疗保健中的决策,从个体患者的治疗决策到国家公共卫生政策的制定。

目的

评估2011 - 2012年期间十本印度牙科杂志中随机对照试验(RCT)的报告质量。

材料与方法

本研究纳入了2011年至2012年期间在十本印度牙科杂志上发表的所有作为全文文章报告的随机对照试验。通过检索Medline识别相关试验。三位作者还对这些杂志进行了手工检索,以检查是否遗漏了任何潜在试验。根据Schulz等人(2010年)描述的《试验报告统一标准》标准工具对每篇文章进行评估。

结果

每篇文章符合标准的平均数量为12.2(标准差[SD]=2.2),106篇文章中只有5篇获得了总分。大多数文章(69%)未提及样本量计算的理由,89%的文章未提及分配隐藏,86%的文章未提及资金情况,63%的文章未提及研究的局限性。

结论

十本印度学术期刊中随机临床试验的报告质量较差。

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