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使用CONSORT清单对整脊疗法随机对照试验报告的质量

Quality of reporting of randomised controlled trials in chiropractic using the CONSORT checklist.

作者信息

Karpouzis Fay, Bonello Rod, Pribicevic Mario, Kalamir Allan, Brown Benjamin T

机构信息

PO Box 2108, Rose Bay, Nth 2030 NSW Australia.

School of Health Professions, Murdoch University, South St., Murdoch, 6150 WA Australia.

出版信息

Chiropr Man Therap. 2016 Jun 9;24:19. doi: 10.1186/s12998-016-0099-6. eCollection 2016.

Abstract

BACKGROUND

Reviews indicate that the quality of reporting of randomised controlled trials (RCTs) in the medical literature is less than optimal, poor to moderate, and require improving. However, the reporting quality of chiropractic RCTs is unknown. As a result, the aim of this study was to assess the reporting quality of chiropractic RCTs and identify factors associated with better reporting quality. We hypothesized that quality of reporting of RCTs was influenced by industry funding, positive findings, larger sample sizes, latter year of publication and publication in non-chiropractic journals.

METHODS

RCTs published between 2005 and 2014 were sourced from clinical trial registers, PubMed and the Cochrane Reviews. RCTs were included if they involved high-velocity, low-amplitude (HVLA) spinal and/or extremity manipulation and were conducted by a chiropractor or within a chiropractic department. Data extraction, and reviews were conducted by all authors independently. Disagreements were resolved by consensus.

OUTCOMES

a 39-point overall quality of reporting score checklist was developed based on the CONSORT 2010 and CONSORT for Non-Pharmacological Treatments statements. Four key methodological items, based on allocation concealment, blinding of participants and assessors, and use of intention-to-treat analysis (ITT) were also investigated.

RESULTS

Thirty-five RCTs were included. The overall quality of reporting score ranged between 10 and 33 (median score 26.0; IQR = 8.00). Allocation concealment, blinding of participants and assessors and ITT analysis were reported in 31 (87 %), 16 (46 %), 25 (71 %) and 21 (60 %) of the 35 RCTs respectively. Items most underreported were from the CONSORT for Non-Pharmacological Treatments statement. Multivariate regression analysis, revealed that year of publication (t32 = 5.17, p = 0.000, 95 % CI: 0.76, 1.76), and sample size (t32 = 3.01, p = 0.005, 95 % CI: 1.36, 7.02), were the only two factors associated with reporting quality.

CONCLUSION

The overall quality of reporting RCTs in chiropractic ranged from poor to excellent, improving between 2005 and 2014. This study suggests that quality of reporting, was influenced by year of publication and sample size but not journal type, funding source or outcome positivity. Reporting of some key methodological items and uptake of items from the CONSORT Extension for Non-Pharmacological Treatments items was suboptimal. Future recommendations were made.

摘要

背景

综述表明,医学文献中随机对照试验(RCT)的报告质量并非最佳,质量较差至中等,有待提高。然而,脊椎按摩疗法RCT的报告质量尚不清楚。因此,本研究的目的是评估脊椎按摩疗法RCT的报告质量,并确定与更好报告质量相关的因素。我们假设RCT的报告质量受行业资助、阳性结果、更大样本量、较晚发表年份以及在非脊椎按摩疗法期刊上发表的影响。

方法

2005年至2014年间发表的RCT来自临床试验注册库、PubMed和Cochrane系统评价。如果RCT涉及高速、低振幅(HVLA)脊柱和/或四肢手法治疗,且由脊椎按摩师或在脊椎按摩疗法科室进行,则纳入研究。所有作者独立进行数据提取和综述。分歧通过协商解决。

结果

制定了一份基于CONSORT 2010和非药物治疗CONSORT声明的39分报告总体质量评分清单。还调查了基于分配隐藏、参与者和评估者设盲以及意向性分析(ITT)使用的四个关键方法学项目。

结果

纳入了35项RCT。报告质量评分范围为10至33分(中位数为26.0;四分位间距 = 8.00)。在35项RCT中,分别有31项(87%)、16项(46%)、25项(71%)和21项(60%)报告了分配隐藏、参与者和评估者设盲以及ITT分析。报告最少的项目来自非药物治疗CONSORT声明。多变量回归分析显示,发表年份(t32 = 5.17,p = 0.000,95%CI:0.76,1.76)和样本量(t32 = 3.01,p = 0.005,95%CI:1.36,7.02)是与报告质量相关的仅有的两个因素。

结论

脊椎按摩疗法中RCT的报告总体质量从差到优不等,在2005年至2014年间有所提高。本研究表明,报告质量受发表年份和样本量影响,但不受期刊类型、资金来源或结果阳性性影响。一些关键方法学项目的报告以及非药物治疗CONSORT扩展项目的采用情况并不理想。提出了未来的建议。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c148/4899907/b2352e1f93b3/12998_2016_99_Fig1_HTML.jpg

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