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骨科外科期刊中报告规范和临床试验注册要求的评估。

An Evaluation of Reporting Guidelines and Clinical Trial Registry Requirements Among Orthopaedic Surgery Journals.

机构信息

Oklahoma State University Center for Health Sciences, Tulsa, Oklahoma.

Department of Orthopaedics, Oklahoma State University Medical Center, Tulsa, Oklahoma.

出版信息

J Bone Joint Surg Am. 2018 Feb 7;100(3):e15. doi: 10.2106/JBJS.17.00529.

Abstract

BACKGROUND

The responsibility for ensuring that studies are adequately reported is primarily that of those conducting the study; however, journal policies may influence how thoroughly authors choose to report their research. The use of reporting guidelines and prospective trial registration are promising avenues for ensuring that published studies adhere to the highest methodological standards. The purpose of this study is to evaluate orthopaedic surgery journal policies regarding reporting guidelines and trial registration, and to evaluate the effects that these policies have on adherence to reporting.

METHODS

We conducted a cross-sectional survey of journal policies and "Instructions for Authors" to determine the journals' policies and guidance regarding use of reporting guidelines and study registration. We also examined whether trials published in journals referencing CONSORT (Consolidated Standards of Reporting Trials) had higher rates of compliance with publishing a CONSORT flow diagram and whether journals with trial registration policies were more likely to contain registered trials than journals without these requirements.

RESULTS

Of the 21 orthopaedic surgery journals, 6 (29%) did not mention a single guideline, and clinical trial registration was required by 11 (52%) orthopaedic surgery journals and recommended by 2 (10%). Of the 21 general medical journals, 3 (14%) did not mention a single guideline, and trial registration was required by 13 (62%) general medical journals and recommended by 5 (24%) others. Furthermore, journals that referenced CONSORT were more likely to publish trials with a CONSORT flow diagram. Journals with trial registration policies were more likely to publish registered trials.

CONCLUSIONS

Reporting guidelines and trial registration are suboptimally required or recommended by orthopaedic surgery journals. These 2 mechanisms may improve methodology and quality, and should be considered for adoption by journal editors in orthopaedic surgery.

CLINICAL RELEVANCE

Because orthopaedic surgeons rely on high-quality research to direct patient care, measures must be taken to ensure that published research is of the highest quality. The use of reporting guidelines and prospective clinical trial registration may improve the quality of orthopaedic research, thereby improving patient care.

摘要

背景

确保研究得到充分报告的责任主要在于进行研究的人员;然而,期刊政策可能会影响作者选择报告其研究的详尽程度。使用报告准则和前瞻性试验注册是确保已发表研究符合最高方法学标准的有希望的途径。本研究的目的是评估骨科手术期刊关于报告准则和试验注册的政策,并评估这些政策对报告依从性的影响。

方法

我们对期刊政策和“作者须知”进行了横断面调查,以确定期刊关于使用报告准则和研究注册的政策和指导。我们还检查了在提到 CONSORT(临床试验报告统一标准)的期刊上发表的试验是否具有更高的遵守发布 CONSORT 流程图的比率,以及具有试验注册政策的期刊是否比没有这些要求的期刊更有可能包含已注册的试验。

结果

在 21 种骨科手术期刊中,有 6 种(29%)没有提到单一准则,有 11 种(52%)骨科手术期刊需要临床试验注册,有 2 种(10%)推荐临床试验注册。在 21 种普通医学期刊中,有 3 种(14%)没有提到单一准则,有 13 种(62%)普通医学期刊需要临床试验注册,有 5 种(24%)推荐临床试验注册。此外,参考 CONSORT 的期刊更有可能发表带有 CONSORT 流程图的试验。有试验注册政策的期刊更有可能发表已注册的试验。

结论

骨科手术期刊对报告准则和试验注册的要求或推荐不理想。这两种机制可能会提高方法学和质量,并且应该考虑由骨科手术期刊编辑采用。

临床相关性

由于骨科医生依靠高质量的研究来指导患者护理,因此必须采取措施确保已发表的研究具有最高质量。使用报告准则和前瞻性临床试验注册可以提高骨科研究的质量,从而改善患者护理。

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