中国临床研究协调员职业倦怠现状及应对措施探析

Current situation and countermeasures of job burnout of clinical research coordinators in China

目的了解临床研究协调员(clinical research coordinator,CRC)职业倦怠水平,提出相关应对措施,为促进CRC行业发展,保障临床试验的质量提供依据。方法采用方便抽样方法,于2019年11月通过中国CRC之家核心联络员对我国CRC进行线上问卷调查,并采用职业倦怠量表(中国版)测量CRC的职业倦怠水平。采用logistic回归模型分析职业倦怠的影响因素。结果发放问卷3139份,回收有效2840份,有效率90.5%。被调研对象大多为女性(占94.9%)、未婚(占64.2%)。职业倦怠量表中,情绪耗竭维度得分为(11.72±5.64)分,去人性化维度得分为(6.65±4.77)分,低个人成就感维度得分为(15.79±6.62)分。CRC职业倦怠检出率为51.4%,其中轻度758人(占26.7%),中度504人(占17.7%),重度199人(占7.0%)。logistic回归分析结果表明:相比≤25岁的CRC,26~30岁的CRC发生职业倦怠的可能性更低(OR=0.79,P<0.05)。工作年限为1~2年及>2年的CRC发生职业倦怠的可能性分别是工作<1年CRC的1.30、1.37倍(P<0.05)。每周工作时间48 h以上者发生职业倦怠风险是每周工作时间<40 h的1.96倍(P<0.05)。未婚、在一线城市工作、工作没有得到研究者的尊重和支持、对CRC的发展前景没有清晰认识、对隶属单位无归属感者发生职业倦怠的风险分别提高至1.37、1.70、1.88、1.81、2.36倍(P<0.05)。结论我国CRC人群职业倦怠检出率较高,推行CRC固定在一家研究中心工作的定点模式,增强对CRC的人文关怀,改善薪酬激励制度,加快建设CRC的职业认定和培训体系,可以提高CRC队伍综合素质和能力,减少CRC职业倦怠的发生,提高我国临床试验水平。

Objective To understand the job burnout levels of the clinical research coordinators(CRCs)in China and propose relevant coping strategies in order to promote the development of the CRC profession and ensure the quality of clinical trials.Methods Using convenient sampling,an online survey of CRCs in China was conducted in November 2019 through core liaisons of the China CRC Home with the job burnout scale(Chinese version)to measure CRC job burnout levels.Logistic regression models were used to analyze factors influencing job burnout.Results A total of 3139 questionnaires were distributed,and 2840 valid responses were received,for an effective response rate of 90.5%.The majority of respondents were female(94.9%)and unmarried(64.2%).The scores for dimensions of emotional exhaustion,depersonalization,and educed personal accomplishment were 11.72±5.64,6.65±4.77,and 15.79±6.62,respectively.The prevalence of job burnout in these CRCs was 51.4%,including 758 individuals with mild burnout(26.7%),504 individuals with moderate burnout(17.7%),and 199 individuals with severe burnout(7.0%).Logistic regression analysis showed that,compared to CRCs aged≤25 years old,those aged 26-30 were less likely to experience job burnout(OR=0.79,P<0.05).CRCs with work experience of 1-2 years or>2 years had 1.30 and 1.37 times higher odds of job burnout than those with less than 1 year of work experience(P<0.05).CRCs working≥48 hours per week had a 1.96-fold higher risk of job burnout compared to those working<40 hours per week(P<0.05).Being unmarried,working in a first-tier city,not receiving respect and support from researchers,having an unclear understanding of CRC career prospects,and lacking a sense of belonging to the affiliated organization increased the risk of work burnout by 1.37,1.70,1.93,1.81,and 2.36 times,respectively(P<0.05).Conclusions CRCs in China had a high prevalence of job burnout.The measures,including implementing a fixed-point working model for CRCs to work in one research center,enhancing humanistic care,improving salary and incentive systems,and accelerating the establishment of CRC certification and training systems,could improve the comprehensive quality and capacity of the CRC workforce,reduce job burnout,and increase the quality of clinical trials in China.