The term “burnout” was coined by psychologist Herbert Freudenberger in 1974 in the article “Staff Burnout,” in which he discussed job dissatisfaction caused by professional stress [1].
There is no standard definition of burnout, but, currently, the most accepted and widespread is the one given by Maslach and Jackson, describing burnout as a tridimensional psychological syndrome, in which professionals who provide human services display emotional exhaustion, depersonalization in client attention and feelings of low personal accomplishment. Put more simply, a job-related state of physical and mental exhaustion, where coping methods are not sufficient [2].
The first burnout dimension is the emotional exhaustion, which refers to stress feelings as depression, hopelessness, anger, loneliness, irritability, impatience, tension, decreased empathy, a sense of lack of energy, and worry. The second dimension, defined as depersonalization, is the tendency to put distance from the recipients of the service, accompanied by a sense of alienation, as well as callousness and indifference towards others, which in turn gives way to cynicism; consequently, working with other people is often considered unpleasant and undesirable. Finally, the feeling of low professional achievement or low job satisfaction (third dimension) can be described as the awareness that very little has been attained and what is accomplished is worthless [2, 3].
Burnout syndrome is responsible for undesirable consequences, both in personal and professional spheres, affecting not only workers themselves, but also their families, the work environment, and the organizations [4]. A variety of psychosomatic and organic health issues are influenced by burnout [5].
Furthermore, burnout has been associated with substance abuse, depression and suicide, as well as medical errors, professional misconduct, departure from the oncology profession, and early retirement [6,7,8,9,10,11].
Burnout is considered one of the most important occupational health problems in various professions involving working with other people [12] and it is listed in the International Statistical Classification of Diseases and Related Health Problems, 10th revision (ICD-10), under the category “Problems related to life-management difficulty” [13].
The phenomenon of burnout syndrome among health care professionals has been extensively investigated, predominantly focusing on physicians [7, 8, 14,15,16,17,18,19,20] and nurses [21,22,23,24,25,26,27,28,29,30]. However, literature concerning burnout in clinical research, with particular regard to the professional figures dedicated to its coordination and management, including Clinical Research Coordinators (CRCs), is poor and often referred to a work environment far away from the Italian one.
Mueller and Mamo in 2002 reported three major critical areas faced by CRCs: work autonomy/control, relationship with patients and physicians, and clinical or technical skills and knowledge [31]. Höglund et al. [32] showed CRCs’ ethical dilemmas, such as conflict between their obligations to clinical trials and those to participants. Other studies highlighted issues with multitasking, feeling of isolation, job control, workload, working with patients, collaboration with other healthcare professionals, and uncertainty towards career development [33,34,35,36]. Furthermore, Gwede et al. [37] compared burnout levels in CRCs to those reported by other healthcare professionals and Matsumoto et al. [38] tried to validate a psychometric testing for a CRCs Stressor Scale.
However, at the time and place in which these studies were conducted, the figures of the research nurse and the CRC were overlapping to a certain extent, while nowadays in Europe, especially in the field of oncology research, these are two distinct professional figures, with very different duties and stressors.
In most of the Italian trial centers, CRC’s daily work involves close interaction with principal investigators, sub-investigators, nursing staff, sponsors, contract research organizations, ethical committees, and national competent authorities, to ensure that clinical trials are carried out correctly in terms of patient compliance, study procedures, collection of the data, and administrative and other study-related issues. CRC activities are wide ranging and include administrative and regulatory compliance, protocol management, data collection, case report form (CRF) completion and query resolution, serious adverse event reporting, and activity monitoring. However, CRC workload varies substantially among Italian and European institutions, mainly because of the lack of common guidelines on the role and duties of this professional figure. Few articles on the activities of a CRC and on the number of studies in which CRCs are involved are available on MEDLINE, and all vary substantially in the information they provide [39].
Due to this substantial lack of knowledge, the Italian Group of Clinical Research Coordinators (GIDM) conducted the present study, based on a survey among its associates aimed at investigating the prevalence of self-reported stress and burnout symptoms in CRCs working in clinical research, as well as evaluating the applicability of a standardized tool such as the Maslach Burnout Inventory (MBI) in this population.