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. 2022 Apr 5;30(3):349–361. doi: 10.1080/13218719.2022.2035840

Burnout among lawyers: effects of workload, latitude and mediation via engagement and over-engagement

Marion Nickum 1, Pascale Desrumaux 1,✉
PMCID: PMC10281412  PMID: 37346056

Abstract

The legal profession is subject to many stereotypes, and it is difficult to find figures in France on the reality of the psychological difficulties in this profession. Burnout is especially a significant problem among these professionals. Practicing as a lawyer may involve high levels of stress and burnout. This study aimed at testing how exhaustion was influenced by workload, latitude and engagement. A self-administered questionnaire was completed by 181 French lawyers. Based on the results, the level of burnout among lawyers decreased with decision latitude but increased with workload. Mediation analyses showed that work engagement and over-engagement had a total mediating role between latitude and burnout. Over-engagement played a partial mediating role between workload and burnout. Several practical implications were developed from these results.

Key words: burnout, engagement, latitude, lawyers, workaholism, workload

Introduction

Stereotypes about lawyers are quite strong and diverse, mainly because of movies and television shows. In reality, being a lawyer is a job with heavy workloads that require a high level of precision and may involve difficulties on many levels. Few figures are available on the various psychological problems that lawyers may encounter in France. According to Glomb et al. (2004), the lawyer ranks twelfth in the ranking of the professions with the highest emotional burden. International research has shown that lawyers are highly affected by problems related to their psychological health, sometimes more than the general population, including depression, anxiety, addiction problems (Bergin & Jimmieson, 2014) and suicide (Marcus, 2014). Lawyers are among the professionals most at risk of suffering from burnout (Carter, 2006; Morgillo, 2015).

Pines and Aronson (1988) consider three-dimensional burnout as a state of physical, emotional and mental exhaustion that is due to an overly long involvement in ‘emotionally demanding situations’. Emotional exhaustion refers to the feeling of no longer being able to respond effectively to the demands of the social environment; mental exhaustion refers to all complaints related to a feeling of weakening and ‘mental fatigue’; physical exhaustion is the set of complaints related to one’s physical state. In a study by Cadieux et al. (2019), the prevalence of burnout was 19% in their sample of Quebec lawyers. Moreover, certain categories of lawyers appear to be more affected (private sector) than others (public sector and businesses). Burnout is the consequence of organizational and dispositional factors (Desrumaux et al., 2018; Laschinger & Grau, 2012). The objective of the present work is to study the risk factors and protective factors of burnout among French lawyers.

Burnout, workload and decision latitude

Exposure to multiple psychosocial risks can jeopardize the psychological health of lawyers in the workplace (Cadieux et al., 2019). According to several authors (Brough & Boase, 2019; Tsai et al., 2009), lawyers run the highest risk of suffering from occupational stress, which is known to increase the risk of burnout (Truchot, 2016). Among lawyers, chronic occupational stress is reportedly associated with toxic work environments (Brough et al., 2016) and burnout (Tsai et al., 2009). Occupational stress can be explained on the basis of several models.

According to the Job Demands–Resources model (Bakker & Demerouti, 2007), high demands in conjunction with low resources produces the highest levels of stress and burnout (Bakker et al., 2005). Job demands refer to the physical, social or organizational aspects of a job that require sustained effort (e.g. workload) and are associated with costs (e.g. exhaustion). The concept of job resources refers to positive personal or organizational aspects that help in achieving work goals and stimulate well-being (e.g. job decision latitude). More specifically, Karasek’s (1979) Job Demands Control model allows us to understand occupational stress as depending on both workload (job demands) and decision latitude (job control). Workload corresponds to the demands and constraints imposed on the individual and the time available to satisfy them. Decision latitude corresponds to the individual’s capacity to control his or her work, role in decisions and use of skills.

Regarding lawyers, several studies (Brough & Boase, 2019; Seligman et al., 2005; Tsai et al., 2009) have found that workload increases psychological tension and decreases job satisfaction, while decision latitude is positively related to good psychological health. In general, the research has confirmed that workload and decision latitude are associated with burnout. Workload increases emotional exhaustion (Greenglass et al., 2003; Maslach et al., 2001) and burnout (Leroy-Frémont et al., 2014). By contrast, decision latitude is negatively correlated with burnout (Hatch et al., 2019; Maslach et al., 1986; Schaufeli et al., 2009). Crawford et al. (2010) extended the Job Demands–Resources model to account for inconsistencies in relationships between demands and engagement. Their revised theory states that demands and burnout are positively associated, whereas resources and burnout are negatively associated. A longitudinal study by Hatch et al. (2019) showed that job demands and job resources each predicted unique variance in burnout and depression symptoms over time. We therefore hypothesized that:

Hypothesis 1: Workload is positively related to burnout.

Hypothesis 2: Decisional latitude is negatively related to burnout.

Burnout, engagement and over-engagement

Litigation is, by nature, a high-stress occupation, demanding a high level of engagement from the contesting lawyers (Morgillo, 2015). Wallace (1997) explained that lawyers have a strong tendency to work ‘24 hours a day’ and that, according to surveys of lawyers, they work an average of more than 50 hours a week. In this professional context, there is a paradox: organizations promote intense work engagement (Tremblay & Mascova, 2013) while burnout issues are increasingly present and have increasingly higher costs on productivity and health (Desrumaux et al., 2018). The Job Demands–Resources model and the Job Demands Control model provide useful frameworks for understanding how job demands and job resources may lead to job strain and burnout, but questions remain about the roles played by mediating variables such as engagement. It is therefore very interesting to look at the concepts of work engagement and over-engagement because these more dispositional characteristics influence burnout.

Engagement is a psychological process resulting from the interaction of three ‘forces’ that enable the person to ‘maintain a line of action towards a social object’: emotional strength, behavioral strength and cognitive strength (Dubé et al., 1997). These three forces reflect the dynamic, cyclical and evolving nature of engagement. Emotional strength (i.e. enthusiasm) could be a trigger for engagement. Motivation, as part of emotional strength, is the combination of interest in an object and the energy of engagement to that object. Behavioral strength (i.e. perseverance) allows actions to continue despite obstacles. Cognitive strength is the ability to realize that getting involved can lead to difficulties that must be accepted to have other benefits (Brault-Labbé & Dubé, 2009).

Engagement protects health because it notably increases psychological well-being at work (Jodoin, 2000). Lee et al. (2000), for instance, found that emotional engagement in work decreased burnout. Van Beek et al. (2011) showed that engaged employees experienced lower levels of burnout. In the Job Demands–Resources model (Bakker & Demerouti, 2007), work engagement and burnout are linked (Bakker et al., 2014). Psychological, social and organizational job resources can protect a person from burnout by facilitating the achievement of work goals and reducing job demands and overload (Bakker & Demerouti, 2007).

Given these findings, we set forth the following hypothesis:

Hypothesis 3: Engagement is negatively related to burnout.

Choi (2013) insisted on differences between work engagement and workaholism. Various authors have found that ‘intense’ engagement is different from ‘excessive’ engagement (Brault-Labbé & Dubé, 2009). Many lawyers work long hours, which may be dangerous for achieving a balance in a person’s functioning. More specifically, over-engagement seems to be qualitatively different from high engagement because it involves different psychological components. More than a quantitative difference, it is mainly the qualitative psychological components of over-engagement that explain its negative association with subjective well-being and physical well-being (Jodoin, 2000). Thus, contrary to engagement, over-engagement (too much involvement in work) can be detrimental to well-being. Like engagement, over-engagement is composed of three dimensions: first, the person’s dominant interest is work, with a limited number of other life interests; second, the dimension of disinterest in personal life and a sense of neglect because of work; third, the compulsive persistence in work tasks (Brault-Labbé & Dubé, 2009). Over-engagement is reminiscent of what other authors refer to as workaholism, a term often associated with lawyers (Daicoff, 2004).

Moreover, the over-engagement of lawyers can be partially explained by the fact that professionals with a high level of education tend to have a higher level of over-engagement (Siegrist et al., 2004). The literature on this topic has shown that there is a relationship between high or excessive levels of engagement and burnout. For example, significant positive correlations between burnout and over-engagement have been found among students (Libert et al., 2019), among bank employees (Andreassen et al., 2007) and among employees working in all sectors (Van Beek et al., 2011). These studies suggest that the depletion of mental resources due to over-engagement leads to burnout, so we set forth the following hypothesis:

Hypothesis 4: Over-engagement is positively related to burnout.

The mediating role of engagement and over-engagement

Brault-Labbé and Dubé’s model (2009) is very interesting because its integrative nature makes it possible to understand the mechanisms at the origin of engagement in all of an individual’s activities. Previous studies have revealed various predictors of engagement. First, engagement depends on personal characteristics (Lambert et al., 1999) and attitudes towards work, such as work participation (Lambert, 2004). Second, engagement is related to organizational factors, which include organizational management, such as opportunities for advancement and organizational justice (Jiang et al., 2018; Lincoln & Kalleberg, 1990). Among judges, for example, job stress may gradually ‘wear down’ staff, leading them to see their work and the organization more negatively and thus reduce their engagement (Lambert et al., 2007). Among prison staff, previous research has shown that work stress is negatively associated with emotional engagement (Hogan et al., 2013). In contrast, decision latitude has been shown to play a motivating role and increase engagement (Hopkins & Gardner, 2012). Whereas the relationship between resources and engagement is consistently positive, the relationship between demands and engagement is highly dependent on the nature of the demand (Crawford et al., 2010).

Over-engagement is believed to be a product of organizational variables, personal variables and job characteristics. In terms of job stress, it can therefore both reduce ‘healthy’ engagement in the organization and create a risk of work addiction. Indeed, it has been found that the risk of over-engagement increases when there is a high workload (Machado et al., 2015) and little decision-making latitude (Andreassen et al., 2018). In their extended theory of Job Demands–Resources, Crawford et al. (2010) showed that demands that employees tend to appraise as hindrances were negatively associated with engagement, and demands that employees tended to appraise as challenges were positively associated with engagement.

Fernet et al. (2013) showed that the link between work characteristics and burnout was mediated by the satisfaction of needs. Moreover, work engagement is known to be a mediator between professional beliefs and job satisfaction (Balasubramanian & Lathabhavan, 2018). At the organizational level, engagement also mediates the relationships between perceived organizational support, interpersonal conflict at work and counterproductive behaviors at work (Sulea et al., 2012). In addition, engagement is a mediator between decision latitude, feedback, task variety and proactive behaviors (Salanova & Schaufeli, 2008). These studies justify the following hypotheses:

Hypothesis 5a: Engagement mediates the relationship between workload and burnout.

Hypothesis 5b: Engagement mediates the relationship between decision latitude and burnout.

Research has also pointed out a positive relationship between job demands and workaholism (Machado et al., 2015) and a negative relationship between job control and workaholism (Andreassen et al., 2018). The study by Molino et al. (2016) found a mediating role of over-engagement between workload and resources (security and opportunity for change), and between work–family conflict and burnout. Andreassen et al. (2018) showed that over-engagement played a mediating role between workload, decision latitude, effort-reward imbalance and health outcomes, including emotional exhaustion. The results of these various studies led us to the following hypotheses.

Hypothesis 6a: Over-engagement played a mediating role in the relationship between workload and burnout.

Hypothesis 6b: Over-engagement played a mediating role in the relationship between decision latitude and burnout.

In the present study, we used a multivariate approach (Figure 1) to verify our hypotheses. We tested for the respective effects of each type of predictor (workload, decision latitude) and each mediator (engagement, over-engagement) on burnout.

Figure 1.

Figure 1.

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Hypothetical model of burnout among lawyers.

Method

Participants

The sample consisted of 181 French lawyers (121 women, 60 men) from several bar associations. The average age of the lawyers was 40 years (M = 40.76, SD = 11.64), and the majority were in a partnership (148 in couples, 33 single). The average bar seniority was not very high (M = 13.38, SD = 11.57). In terms of professional background, the majority were either staff lawyers and associates (73) or self-employed (62). The lawyers’ areas of expertise were highly varied: 34 specific skills were identified and could be grouped into three areas (public law, private law, criminal law). However, 57 of the lawyers had more than one area of expertise: 19 lawyers had at least one area of competence in public law, 147 did so in private law, and 56 did so in criminal law. In addition, 21 of the lawyers were not specialized, and 33 did not respond. Finally, 156 of our lawyers estimated that they worked an average of 50 hours per week (M = 51.18, SD = 10.59), with some estimating as many as 90 hours per week.

Materials and procedure

The online questionnaire consisted of six scales and seven demographic questions (age, sex, seniority, etc.). Cronbach’s α for the study scales indicated satisfactory internal consistency for all scales (Table 1).

Table 1.

Means, standard deviations and correlations between the study variables.

Variable M SD 1 2 3 4 5
1. Workload 5.26/7 0.71 .66        
2. Decision latitude 5.81/7 0.61 .002 .67      
3. Engagement 5.71/8 1.13 .004 .45** .83    
4. Over-engagement 2.92/8 1.45 .33** −.17* –.11 .90  
5. Burnout 4.07/7 0.95 .47** –.16* –.33** .56** .87
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Note: N = 181 participants. Cronbach’s alphas are in boldface along the diagonal.

*p < .05. **p < .01.

The online questionnaire was self-administered on a voluntary basis. An informed consent form specified the objectives of the study, the nature of the participation, a guarantee of anonymity, the right to withdraw at any time, the management of confidentiality and the monitoring of data and publications. The consent form was filled out just before the questionnaire.

Workload

The workload scale of Karasek et al. (1998) consisted of nine items (e.g. My job requires me to work very fast). Each item was rated from 1 (strongly disagree) to 7 (strongly agree).

Decision latitude

Based on Karasek et al.’s scale (1998), decision latitude was measured by nine items (e.g. I have the possibility of influencing the way my work is done), ranging from 1 (strongly disagree) to 7 (strongly agree).

Engagement

The psychological engagement scale at work, developed by Jodoin (2000) based on Dubé et al. (1997), included 12 items. The items were reformulated to correspond to work over the last 6 months. Each item (e.g. I am enthusiastic about my work) was rated from 0 (does not characterize me at all) to 8 (characterizes me completely).

Over-engagement

The over-engagement scale, developed in Jodoin’s (2000) thesis, consisted of 16 items and covered the last 6 months of work. Each item (e.g. At work, I finish what I started, even if it must be detrimental to my physical health) was rated from 0 (does not characterize me at all) to 8 (characterizes me completely). This scale has been validated, and its psychometric properties were good, especially in terms of factor structure, internal consistency and validity.

Burnout

The Burnout Measure Short (BMS) by Malach-Pines (2005), translated and validated in French by Lourel et al. (2007), has been used. It measured burnout according to three dimensions: physical, mental and emotional. The scale had 10 items (e.g. did you feel tired) each item ranging from 1 (never) to 7 (always).

Results

Descriptive analyses and correlations

The means, standard deviations and bivariate correlations (calculated with SPSS, Version 20 software) are presented in Table 1. The mean burnout is high (M = 4.07/7, SD = 0.95), given that a score between 3.5 and 4.4 indicates the presence of burnout (Lourel et al., 2007). In addition, 92 of the 181 participants scored above this mean.

The correlations (Table 1) between burnout and workload (r = .47, p < .01) and between burnout and over-engagement (r = .56, p < .01) were significant. Having high work demands and being over-engaged was associated with an increased risk of burnout among lawyers. In addition, there were significant negative correlations between decision latitude and burnout (r = −.16, p < .05), and between engagement and burnout (r = −.33, p < .01). Among lawyers, being very engaged to one’s work and having strong control was linked to a decrease in the risk of burnout.

Mediation analysis

Hayes and Preacher’s (2014) SPSS macro was used to test the observed direct and indirect links, based on regression and non-parametric bootstrapping (10,000 alternative samples generated). This method (Hayes & Preacher, 2014) calculates the mediation effect (indirect effect) as the subtraction of the Link C’ (direct effect of an independant variable, IV, on the dependant variable, DV) from the Link C (total effect of an IV on the DV taking into account the indirect effect of the mediator, MV). Furthermore, Link A is the specific effect of an IV on a MV, while Link B is the specific effect of an MV on the dependent variable. The bootstrapping method is robust against potential biases resulting from non-normal data distributions (Hayes & Preacher, 2014).

The results (Table 2) pointed out the mediating effects of engagement and over-engagement between the different types of independent variables (workload and decision latitude), based on the Hayes and Preacher (2014) method. When the inducer is workload, over-engagement played an indirect role in the relationship between workload and burnout. The indirect effect mediated by over-engagement (β = .16, 95% confidence interval, CI [.09, .27], p < .05) was significant but the one mediated by engagement was not (β = .01, 95% CI [−.04, .07], p > .05). Plus, the mediating effect of over-engagement was partial between workload and burnout. Indeed, a direct link between workload and burnout was maintained for over-engagement (C ′ = .47, p < .001). These results validate Hypothesis 6a but do not validate Hypothesis 5a. When the predictor was latitude, engagement and over-engagement mediated the relationship between latitude and burnout. Significant indirect effects were found via engagement (β = −.26, 95% CI [−.40, −.14], p < .05) and over-engagement (β = −.19, 95% CI [−.32, −.07], p < .05). The mediating effects of engagement and over-engagement were total between latitude and burnout. Indeed, the direct links between latitude and burnout were not maintained simultaneously for both engagement (C ′ = .07, ns) and over-engagement (C ′ = .07, ns). Hypotheses 5b and 6b were therefore validated.

Table 2.

Mediation results with burnout as the dependent variable.

IV MV Total effect(Link C) Effect of IV on MV(Link A) Effect of MV on DV(Link B) Direct effect(Link C′) Indirect effect(Link C – Link C′) 95% CI
Workload Engagement .66** –.06 –.26** .47** .01 [–.04, .07]
Over-engagement .66** .64** .26** .47** .16a [.09, .27]
Decision latitude Engagement –.38** .95** –.27** .07 –.26a [–.40, .14]
Over-engagement –.38** –.57* .34** .07 –.19a [–.32, .07]
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Note: N = 181. IV = independent variable; MV = mediating variable; DV = dependent variable; CI = confidence interval. Bootstrapping N = 10,000.

ap < .05 (bootstrapping 95% CI does not include zero).

*p < .05; **p < .01.

Discussion

The aim of this study was to highlight the presence of positive and negative aspects in burnout among lawyers. As a whole, our findings are in line with previous research on the Job Demands Control model. We tested the ways in which workload, decision latitude, engagement and over-engagement affected burnout, as well as possible mediation through engagement and over-engagement. The results highlighted the relevance of our four variables and certain links with burnout. This is the first study to illustrate that burnout is significantly associated with engagement and over-engagement as mediators.

Our first two hypotheses concerned the link between the dimensions of Karasek’s model (1979) and burnout. As hypothesized (Hypothesis 1), our results indicated that workload was linked to burnout. The work of a lawyer is very demanding and can therefore cause burnout. As with executives (Leroy-Frémont et al., 2014), when lawyers are faced with a heavy workload, they may experience burnout. Their psychological health is impacted because stressful demands are exhausting (Bakker et al., 2005). Aligning with Hypothesis 2, our results confirmed the relationship between decision latitude and burnout.

For our analysis of the role of engagement and over-engagement as mediators between workload, decision latitude and burnout, we began by testing and confirming Hypotheses 3 and 4, whereby engagement and over-engagement are linked to burnout. As prior studies have shown for other occupations (Lee et al., 2000; Van Beek et al., 2011), our results confirmed, for lawyers, that engagement was negatively associated with burnout. In line with previous studies with students (Libert et al., 2019) and workers (Andreassen et al., 2007; Van Beek et al., 2011), our results also validated Hypothesis 4 for lawyers, showing that over-engagement was positively associated with burnout. Engaging too strongly in one’s work, while neglecting other spheres of life, can cause exhaustion. The transition from strong engagement to over-engagement therefore has many negative consequences on psychological health.

As a second step, we sought to find out whether engagement and over-engagement played a mediating role between resources, demands and burnout. We noticed, firstly, that job decision latitude increased engagement. This corresponds to the results found by Hopkins and Gardner (2012): control over one’s work encourages learning and the desire to improve, thus motivating the professional to achieve his or her objectives and commit to the work. Decision latitude also decreased over-engagement, which means that non-personal variables can affect over-engagement. Lastly, workload increased over-engagement, as in the literature (Machado et al., 2015).

Thus, our statistical analyses indicated that Hypotheses 6a, 6b and 5b were validated but Hypothesis 5a was not. As a whole, both variables played mediating roles. Confirming Hypothesis 5b, engagement played a mediating role in the relationship between decision latitude and burnout. Our results showed that engagement in work is related to need satisfaction and plays a central role in predicting burnout (Fernet et al., 2013). Hypothesis 6a, which predicted that over-engagement would play a mediating role in the relationship between workload and burnout, was validated. These results align with studies on the role of over-engagement as a mediator between workload and burnout (Molino et al., 2016) and health (Andreassen et al., 2018). Hypothesis 6b stating that over-engagement played a mediating role in the relationship between decision latitude and burnout was also validated. Our results are consistent with previous studies on role of over-engagement as a mediator between latitude and health (Andreassen et al., 2018). These results showed that engagement and over-engagement were a function of the work environment and predicted various health outcomes among lawyers.

Limitations and avenues for future research

One limitation of this study concerned the cross-sectional design and the use of a self-administered questionnaire, which can lead to biases (e.g. social desirability). We cannot draw any conclusions regarding the directionality and causality among the study variables. Further, the cross-sectional design may make the results vulnerable to a common methodological bias, since all data were based on self-report (Lindell & Whitney, 2001). Another limitation concerns the use of an online questionnaire, which can have effects such as distracting the respondent from his or her work. Consequently, in future studies, the model used should preferably be investigated using a longitudinal or experimental design to test for causal effects.

Next, we did not measure support. The Job Demands Control model (Karasek, 1979) considers that the combination of high psychological demands and low decision latitude will be less destructive if the person is supported. This model evolved into the Job Demands Control Support model proposed by Johnson and Hall (1988). In these two models, co-worker support and supervisor support were added as positive health variables (Truchot, 2016). Although supervisor support can decrease the risk of burnout (Desrumaux et al., 2018), it was not a relevant variable in our study where all professional categories of lawyers were examined. This is simply because supervisor support concerns only staff lawyers and associates. Support from colleagues is also known to be a relevant factor in decreasing burnout (Hatch et al., 2019). Also, colleague support could depend on the type of organization in which the lawyer works. In future studies, it would therefore be relevant to measure different categories of lawyers (according to the professional setting) and specifically control for sex and age, or to study other sources of social support (inter-professional, family). Also, the only the personal variables in the study were engagement and over-engagement, but many other variables such as self-efficacy and self-esteem (Dose et al., 2019) or optimism and resilience (Desrumaux et al., 2015) could be added because they affect psychological health at work. At the statistical level, workload did not have an impact on engagement, and mediation was partial between workload and burnout, through over-engagement. Also, there are other types of variables influencing engagement and over-engagement. Finally, it would also be interesting to study the positive side of health by choosing to study risk factors, protection factors and the mediating role of the level of engagement in psychological well-being.

Practical implications

This study offers an initial recognition of the reality and extent of the psychological health factors of lawyers. In terms of risk and protective factors, engagement and over-engagement are central because, in addition to directly influencing burnout, they play mediating roles between workload and decision latitude. It seems important to think about preventive measures aimed at promoting engagement and reducing over-engagement.

First, organizations that employ lawyers should try to ensure that the workload is in line with the lawyers’ resources. And they should provide opportunities for increasing decision latitude and social support. Second, with lawyers and their colleagues, various practices could be set up to increase engagement, particularly by encouraging a healthy work climate (Bergin & Jimmieson, 2013; Cadieux et al., 2019; Hopkins & Gardner, 2012). This could include fostering relationships among colleagues (Wallace, 1997) and developing team spirit, collaboration and recognition for work done (Lee et al., 2000). Moreover, given its role as a total mediator between decision latitude and burnout, implementing training or programs to promote worker autonomy would be useful.

Preventive measures to curb over-engagement must be taken because over-engagement can function as a central mechanism in the development of burnout. At the individual level, managers and employees need training to understand what over-engagement means, its causes and its consequences. Access to psychologists and training programs focusing on self-efficacy, time management and stress management could be crucial in preventing over-engagement and burnout (Schabracq, 2005). At the organizational level, where lawyers work in a team and have a supervisor, managing workload appears to be effective. Employees should be exposed to challenging but not exaggerated work demands (Bakker et al., 2009), and the work environment should ensure adequate resources, such as support (Hatch et al., 2019) and professional development opportunities (Molino et al., 2016).

Ethical standards

Declaration of conflicts of interest

Marion Nickum has declared no conflicts of interest.

Pascale Desrumaux has declared no conflicts of interest.

Ethical approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional research committee of the University of Lille who accepted the protocol, forms and anonymous questionnaire and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

Informed consent

Study participants signed an Informed Consent Handbook. Informed consent was obtained from all individual participants included in the study.

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