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患者招募和后勤问题是临床研究中困难的首要问题:一项横断面调查。

Patient enrollment and logistical problems top the list of difficulties in clinical research: a cross-sectional survey.

机构信息

Division of Clinical Epidemiology, Geneva University Hospitals, University of Geneva, Rue Gabrielle Perret-Gentil 6, CH-1211, Geneva 14, Switzerland.

Division of Anesthesia, Department of Anesthesiology, Pharmacology and Intensive Care, Geneva University Hospitals, Geneva, Switzerland.

出版信息

BMC Med Res Methodol. 2016 May 4;16:50. doi: 10.1186/s12874-016-0151-1.

Abstract

BACKGROUND

Many medical research projects encounter difficulties. The objective of this study was to assess the self-reported frequency of difficulties encountered by medical researchers while conducting research and to identify factors associated with their occurrence.

METHODS

The authors conducted a cross-sectional survey in 2010 among principal investigators of 996 study protocols approved by the Research Ethics Committee in Geneva, Switzerland, between 2001 and 2005. The authors asked principal investigators to rate the level of difficulty (1: none, to 5: very great) encountered across the research process.

RESULTS

588 questionnaires were sent back (participation rate 59.0 %). 391 (66.5 %) studies were completed at the time of the survey. Investigators reported that the most frequent difficulties were related to patient enrollment (44.3 %), data collection (26.7 %), data analysis and interpretation (21.5 %), collaboration with caregivers (21.0 %), study design (20.4 %), publication in peer-reviewed journal (20.2 %), hiring of competent study personnel (20.2 %), and getting funding (19.2 %). On average, investigators reported 2.8 difficulties per project (SD 2.8, range 0 to 12). In multivariable analysis, the number of difficulties was higher for studies initiated by public sponsors (vs. private), single center studies (vs. multicenter), and studies about treatment, diagnosis or prognosis (i.e., clinical vs. other studies).

CONCLUSIONS

Medical researchers reported substantial logistical difficulties in conducting clinical research.

摘要

背景

许多医学研究项目都遇到了困难。本研究旨在评估医学研究人员在开展研究时报告的困难频率,并确定与这些困难发生相关的因素。

方法

作者于 2010 年对瑞士日内瓦研究伦理委员会在 2001 年至 2005 年期间批准的 996 项研究方案的主要研究者进行了横断面调查。作者要求主要研究者对整个研究过程中遇到的困难程度(1:无,至 5:非常大)进行评分。

结果

共寄出 588 份问卷(参与率为 59.0%)。在调查时,有 391 项(66.5%)研究已完成。调查人员报告说,最常见的困难与患者入组(44.3%)、数据收集(26.7%)、数据分析和解释(21.5%)、与护理人员的合作(21.0%)、研究设计(20.4%)、在同行评议期刊上发表(20.2%)、雇用有能力的研究人员(20.2%)以及获得资金(19.2%)有关。平均而言,每位研究者报告每个项目有 2.8 个困难(SD 2.8,范围 0 至 12)。多变量分析显示,公共赞助商(vs. 私人赞助商)启动的研究、单中心研究(vs. 多中心研究)以及关于治疗、诊断或预后的研究(即临床研究与其他研究)的困难数量更多。

结论

医学研究人员在开展临床研究时报告存在大量的后勤困难。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4a8f/4855713/1c8ac59a34ed/12874_2016_151_Fig1_HTML.jpg

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