中国全科医学 ›› 2024, Vol. 27 ›› Issue (07): 773-783.DOI: 10.12114/j.issn.1007-9572.2023.0751

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2021年中国基层卫生和全科医学方法学质量评价报告:定量研究、系统综述和指南/共识部分

《中国全科医学》定量研究、系统综述和指南/共识质量评价小组   

  • 收稿日期:2023-10-11 修回日期:2023-11-06 出版日期:2024-03-05 发布日期:2023-12-19

Report on Methodological Quality Assessment of Primary Care and General Practice Research in China in 2021: Quantitative Research, Systematic Review and Guidelines/Consensus Section

Quality Assessment Group for Quantitative Research,Systematic Review and Guidelines/Consensus of Chinese General Practice   

  • Received:2023-10-11 Revised:2023-11-06 Published:2024-03-05 Online:2023-12-19

摘要: 背景 在新时期医疗卫生改革正在实施的当下,我国全科医学和基层卫生领域的科研产出近年来增长迅速,但文献的方法学质量尚不清楚。目的 对我国学者2021年发表的全科医学和基层卫生领域具有代表性的定量研究、系统综述和指南类文献进行方法学质量评价,以呈现该领域科研论文总体的方法学质量特征。方法 自《2021年中国基本保健和全科医学科研论文生产力研究》中收集的3 122篇论文中选取449篇论文,组织由22位来自不同机构的公共卫生和全科医学领域研究人员组成方法学质量评价小组,以2人1组的形式,在1位循证医学方法学专家的培训和指导下,使用6种适用于不同研究设计(横断面研究、队列研究、干预前后研究、随机对照试验、系统综述、临床指南/共识)的质量评价工具,对其中的320篇论文(71.3%)进行质量评价,并运用描述性统计方法,报告质量评价结果。结果 114篇横断面研究论文质量问题主要为研究人群是否代表目标人群(41.2%)、调查工具的可靠性和有效性是否可以确证(32.5%)、该调查是否具有临床意义(26.3%)3个条目;25篇队列研究论文质量问题在是否对队列进行了充分随访(44.0%)和各组之间的共同干预是否相似(56.0%)两个条目较为集中;34篇干预前后研究质量问题主要存在于是否在干预前后多次测量目标结局(97.1%),样本量是否足够大、足以对研究结果产生信心(82.4%)以及研究参与者能否代表符合条件的人群(61.8%)3个条目;122篇随机对照试验质量问题多集中于对不同的利益相关者实施盲法(25.4%~61.5%),对随机分配的充分隐藏(41.8%)及其他偏倚风险(72.1%)3个条目;19篇系统综述质量问题主要存在于是否报告了纳入研究的资助来源(100.0%)、综述方法是否在综述开始前制定(94.7%)、是否合理的讨论和解释了异质性(84.2%)和是否考虑了个别研究的偏倚风险(84.2%)4个条目;6篇临床指南/共识的质量均评价较低。结论 我国基本保健和全科医学领域近年的科研成果在总体上方法学质量仍有限,在横断面研究、干预前后研究、随机对照试验、临床指南/共识等类别的研究中表现得尤为严重。这凸显了在我国这一研究领域加强系统性的基础科研培训、增强对科研和循证报告规范的重视,以及开发务实的制订指南的方法学规范的迫切性和重要性。

关键词: 全科医学, 定量研究, 系统评价, 方法学质量, 研究设计, 指南

Abstract:

Background

At a time when healthcare reforms are being implemented in the new era, the scientific research output in the field of general practice and primary care in China has grown rapidly in recent years. However, the methodological quality of the literature is unclear.

Objective

To evaluate the methodological quality of representative quantitative studies and systematic reviews/guidelines in the field of general practice and primary care in China in 2021, to reveal the overall methodological quality characteristics of scientific papers in this field.

Methods

A sample of 449 papers was selected from a total of 3 122 papers collected in the Primary Care and General Practice Research Paper Productivity Report in China in 2021. A methodological quality assessment group consisting of 22 researchers in the field of public health and general practice from different institutions was organized to evaluate the quality of 320 of these papers (71.3%) using six different quality assessment tools for different study designs (cross-sectional studies, cohort studies, pre- and post-intervention studies, randomized controlled trials, systematic reviews, guidelines and consensus) by working in pairs and under the training and guidance of an expert in evidence-based medical methodology. Descriptive statistics method was used to report the overall quality assessment results of the various types of research papers.

Results

Of the 114 cross-sectional research papers, quality issues were prevalent in the areas of "whether the source population was representative of the study's target population" (41.2%) , "whether the reliability and validity of the survey instrument could be conclusively demonstrated" (32.5%) , "whether the survey is clinically meaningful" (26.3%) ; of the 25 cohort study papers, quality issues were more concentrated in the areas of "whether the cohort was adequately followed up" (44.0%) and "whether the co-intervention was similar among groups" (56.0%) ; of the 34 pre- and post-intervention studies, quality issues were mostly found in the areas of "whether the target outcome was measured multiple times before and after the intervention" (97.1%) , "whether the sample size was large enough to generate confidence in the study results" (82.4%) , and "whether the study participants were representative of the eligible population" (61.8%) ; of the 122 randomized controlled trials, quality concerns were mostly in the areas of "blinding of different stakeholders" (25.4%-61.5%) , "adequate concealment of random allocation" (41.8%) , and "other risks of bias" (72.1%) ; of the 19 systematic reviews, quality issues were mostly found in the areas "is the source of funding for the included studies reported" (100.0%) , "were the methods of the review developed before the start of the review" (94.7%) , "was heterogeneity reasonably discussed and explained" (84.2%) , and "was the risk of bias of individual studies considered" (84.2%) . Finally, the quality of all six clinical guidelines/consensus was rated low.

Conclusion

The scientific research output of recent years in the field of primary care and general practice in China is still of limited quality in general, which is particularly evident in the categories of cross-sectional studies, pre- and post-intervention studies, randomized controlled trials, guidelines and consensus. This highlights the urgency and importance of strengthening systematic training in basic research in this area of research in China, increasing the importance of research and evidence-based reporting standards, and developing pragmatic methodological specifications for the development of guidelines.

Key words: General practice, Quantitative research, Systematic review, Methodological quality, Research design, Guidebooks