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整形手术中的随机对照试验:报告质量的系统评价

Randomised controlled trials in plastic surgery: a systematic review of reporting quality.

作者信息

Agha Riaz Ahmed, Camm Christian F, Doganay Emre, Edison Eric, Siddiqui Muhammed R S, Orgill Dennis P

机构信息

Department of Plastic Surgery, Stoke Mandeville Hospital, Aylesbury, Bucks UK.

Department of Trauma, Emergency, and Acute Medicine, King's College Hospital, London, UK.

出版信息

Eur J Plast Surg. 2014;37(2):55-62. doi: 10.1007/s00238-013-0893-5. Epub 2013 Oct 30.

Abstract

BACKGROUND

We recently conducted a systematic review of the methodological quality of randomised controlled trials (RCTs) in plastic surgery. In accordance with convention, we are here separately reporting a systematic review of the reporting quality of the same RCTs.

METHODS

MEDLINE® and the Cochrane Database of Systematic Reviews were searched by an information specialist from 1 January 2009 to 30 June 2011 for the MESH heading 'Surgery, Plastic'. Limitations were entered for English language, human studies and randomised controlled trials. Manual searching for RCTs involving surgical techniques was performed within the results. Scoring of the eligible papers was performed against the 23-item CONSORT Statement checklist. Independent secondary scoring was then performed and discrepancies resolved through consensus.

RESULTS

Fifty-seven papers met the inclusion criteria. The median CONSORT score was 11.5 out of 23 items (range 5.3-21.0). Items where compliance was poorest included intervention/comparator details (7 %), randomisation implementation (11 %) and blinding (26 %). Journal 2010 impact factor or number of authors did not significantly correlate with CONSORT score (Spearman rho = 0.25 and 0.12, respectively). Only 61 % declared conflicts of interest, 75 % permission from an ethics review committee, 47 % declared sources of funding and 16 % stated a trial registry number. There was no correlation between the volume of RCTs performed in a particular country and reporting quality.

CONCLUSIONS

The reporting quality of RCTs in plastic surgery needs improvement. Better education, awareness amongst all stakeholders and hard-wiring compliance through electronic journal submission systems could be the way forward. We call for the international plastic surgical community to work together on these long-standing problems.

摘要

背景

我们最近对整形手术中随机对照试验(RCT)的方法学质量进行了系统评价。按照惯例,我们在此单独报告对同一RCT报告质量的系统评价。

方法

2009年1月1日至2011年6月30日,信息专家在MEDLINE®和Cochrane系统评价数据库中检索了主题词“整形手术”。设定了英语语言、人体研究和随机对照试验的限制条件。在检索结果中手动搜索涉及手术技术的RCT。根据23项CONSORT声明清单对符合条件的论文进行评分。然后进行独立的二次评分,并通过协商解决差异。

结果

57篇论文符合纳入标准。CONSORT评分中位数为23项中的11.5分(范围5.3 - 21.0)。依从性最差的项目包括干预/对照细节(7%)、随机化实施(11%)和盲法(26%)。期刊2010年影响因子或作者数量与CONSORT评分无显著相关性(Spearman相关系数分别为0.25和0.12)。仅61%声明了利益冲突,75%获得了伦理审查委员会的许可,47%声明了资金来源,16%说明了试验注册号。在特定国家进行的RCT数量与报告质量之间没有相关性。

结论

整形手术中RCT的报告质量需要提高。更好的教育、所有利益相关者的意识以及通过电子期刊投稿系统强制合规可能是前进的方向。我们呼吁国际整形外科学界共同解决这些长期存在的问题。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7fbd/3971436/2629167a5014/238_2013_893_Fig1_HTML.jpg

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