In industry, findings from Pousette et al. (42) support the hypothesis that safety climate (conceptualized as "safety communication" in conjunction with other safety climate dimensions) predicted safety behavior in a longitudinal study. Additionally, findings from Hofmann and Stetzer (27) support the hypothesis that group processes and functioning (the interaction that takes place among employees for example, communication, and coordination) is negatively associated with the number of recordable accidents. Also, findings from Mearns et al. (40) support the hypothesis that safety climate (conceptualized as "communication about health and safety," in conjunction with other safety climate dimensions) was negatively associated with employees experiencing accidents and official accident reports.

In line with congruency theory, the following hypothesis is proposed:

1b. The higher the extent to which safety information flow is perceived as clear and unambiguous to the ICU's daily work demands and processes, the lower the ICU's clinical incidents.

#### **c) Managerial Safety Practices**

"Learning would be exceedingly laborious not to mention hazardous if people had to rely solely on the effects of their own actions to inform them what to do. Fortunately, most human behavior is learned observationally through modeling: from observing others, one forms an idea of how new behaviors are performed and on later occasions this coded information serves as a guide for action" [(43), p. 22]. This approach is known as Social Learning Theory and suggests that people learn through observing others' behaviors, attitudes, and outcomes of those behaviors (43). Therefore, observational learning is governed by four processes; attention, retention, reproduction, and motivation (43).

Managerial safety practices refer to the extent to which employees perceive their manager's behavior toward safety, which lets employees understand the extent to which the manager is committed to safety (17, 18). Zohar (35) argues that the essential dimension of safety climate is in fact, management commitment to safety and this solely suffices as a measure of safety climate. Zohar (22) indicated that in factories having successful safety programs there was a strong management commitment to safety. In low accident companies top management was personally involved in safety activities on a routine basis, whereas such commitment was conspicuously absent in high accident companies. In agreement with this, Zohar and Luria (26) contend that the most significant information is derived from episodes or occurrences that reveal management safety practices. Such episodes or occurrences serve as climate indicators that reveal the priority of key facets, which may differ from formal declarations (26).

#### Managerial Safety Practices as a Mediator Variable

Throughout the years, research studies have empirically explored safety climate (conceptualized as solely managerial safety practices or in conjunction with other safety climate dimensions) in terms of its mediating effects on relationships between various variables and safety related outcomes. However, six of the eight research studies identified, recruited participants from industry whereas two recruited participants from health care, one addressed occupational safety while the other addressed patient safety.

Findings from Zohar (44), McFadden et al. (45), Martinez-Córcoles et al. (46), and Clarke (47) support the hypothesis that safety climate (conceptualized as solely managerial safety practices or in conjunction with other safety climate dimensions) mediated the relationship between leadership style and safety related outcomes. Zohar (44) and Clarke (47) tested both a transformational and transactional leadership style. On other hand, in healthcare addressing specifically patient safety, McFadden et al. (45) simply tested a transformational leadership style. Similarly, Martinez-Córcoles et al. (46) tested a leadership style based on the Empowering Leadership Model. This model identifies five different behaviors empowered leaders must show: leading by example, participative decision making, coaching, informing, and showing concern or interacting with employees.

Despite this, leaders may be transformational in one aspect of the job (achieving high production levels) but passive in other areas (achieving safety standards) (48). Subsequently, transformational leaders are not necessarily safety leaders (48). This is in agreement with findings from Barling et al. (29). Findings support the hypothesis that safety climate (conceptualized as solely managerial safety practices) mediated the relationship between safety specific transformational leadership and occupational injuries. Also, safety climate, safety consciousness, and safety-related events mediated the relationship between safety specific transformational leadership, role overload, and occupational injuries.

Findings from Zacharatos et al. (49) support the hypothesis that safety climate (conceptualized as management values in conjunction with other safety climate dimensions) mediated the relationship between human resource management practices related to high performance work systems and safety performance. Moreover, findings also supported the hypothesis that safety climate and trust in management mediated the relationship between human resources management practices related to high performance work systems and safety incidents. Also, findings from Wallace et al. (50) support the hypothesis that safety climate (conceptualized as solely managerial safety practices) mediated the relationship between management employee relationships and rate of accidents. Additionally, findings also supported the hypothesis that safety climate mediated the relationship between organizational support and rate of accidents.

In line with Social Learning Theory, the following hypotheses are proposed:

2a. Management safety practices mediate the relationship between safety procedure suitability and the ICU's clinical incidents. 2b. Management safety practices mediate the relationship between safety information flow and the ICU's clinical incidents.

#### **d) Safety Priority**

The expectancy theory explains how an employee's behavior is determined by beliefs in three areas: expectancy (the extent to which increased effort will lead to improved performance), instrumentality (the extent to which improved performance will lead to a specified outcome), and valence (the extent to which that outcome is valued by the individual) (51). Performance is a function of skill and motivation. Skill relates to abilities (innate and acquired through, for example, safety procedures, and/or safety information flow) while motivation comprises the effort expended by the employee and the knowledge of what is expected by others (51). Effort is determined by the value to be derived as a result of the effort and the strength of the link between effort and the rewards. Expectancy theory leads employees to ask questions, such as: If I exert more effort is the safety goal attainable? Will the safety goal be rewarded? How much do I value the reward I will receive? Are alternative goals likely to be rewarded more highly? (52).

Safety priority refers to the extent to which employees' perceive safety as a top priority within the organization (17, 18). In other words, safety priority refers to the extent to which employees prioritize safety against work pace, workload, and pressures for production. Employees may base such priorities on their perception of probable consequences of safe or unsafe behavior (17, 18).

### Safety Priority as a Mediator Variable

Throughout the years, research studies have empirically explored safety priority as a mediator that influences the relationship between various variables and safety related outcomes. Griffin and Neal (32) argue that the value that individuals personally place on safety is an individual motivational construct rather that an aspect of safety climate. In view of this, the author included research studies that explored the dimension safety motivation to reflect the dimension safety priority as a mediator that influences the relationship between various variables and safety related outcomes. However, five of the eight research studies identified, recruited participants from industry whereas three recruited from healthcare, one addressed occupational safety, and two addressed patient safety.

In healthcare addressing occupational safety, Neal et al. (28) and in industry, Griffin and Neal (32) hypothesized that safety motivation and safety knowledge would mediate the relationship between safety climate (conceptualized as management values, safety communication, safety training, and safety systems) and safety performance. The researchers' model incorporated two dimensions of safety performance: compliance and participation. Safety compliance refers to core safety behaviors such as employees' adherence to safety rules, regulations, and procedures. Safety participation refers to employees' voluntary engagement or extra effort for safety that goes beyond formal role prescriptions such as participating in a safety committee, helping others with safety matters, or attending a voluntary safety meeting. This differentiation is based on an organizational model of task performance and contextual performance as components of job performance (53). Therefore, compliance activities are generally mandated while participatory activities are generally voluntary. Findings from both research studies indicated that safety motivation and safety knowledge mediated this relationship.

In a meta-analysis, Christian et al. (34) hypothesized that safety climate would positively influence safety performance (through safety knowledge and motivation) and to negatively influence outcomes. Safety climate was conceptualized as management commitment, human resource management practices, supervisor support, internal group processes, boundary management, risk, and work pressure. Findings indicated that safety knowledge and safety motivation mediated the relationship between safety climate and safety performance. A strong safety climate should encourage safe action either through reward or through principles of social exchange (32, 54, 55). Also, a strong safety climate should enhance safety knowledge due to an environment where safety information is communicated formally through training and informally through on-the-job discussions (34). Furthermore, the researchers hypothesized that safety climate would be more strongly related to safety participation than safety compliance, due to the voluntary nature of participation, and the motivational desire of employees to reciprocate manager actions regarding safety (34).

Also, findings from Clarke (56) indicated that perceived safety climate (safety priority and managerial safety practices) mediated the relationship between dimensions of psychological climate (job, role, group, leader, and organizational attributes) and safety behavior. As previously mentioned, finding from McFadden et al. (45) and Clarke (47) supported the hypothesis that safety climate (conceptualized as safety priority and managerial safety practices) mediated the relationship between leadership style and safety related outcomes. Similarly, findings from Zohar (44) supported the hypothesis that priority of safety mediated the relationship between leadership style and safety climate (conceptualized as managerial safety practices). Additionally, findings from Hofmann and Stetzer (27) supported the hypothesis that the tendency for employees to approach one another regarding safety activities (safety priority) mediated the relationship between group processes and functioning (the interaction that takes place among employees for example, communication and co-ordination; information flow) and safety related behavior.

In healthcare addressing patient safety, Naveh et al. (17) contend that, in addition to specific guidance on how to assure safety, safety procedure suitability, and safety information flow send a message about priority of safety. Additionally, the researchers argue that this has a significant role influencing treatment errors (17). Findings support the hypothesis that priority of safety mediated the relationship between safety procedure suitability and treatment errors. Furthermore, that priority of safety mediated the relationship between safety information flow and treatment errors.

In line with expectancy theory, the following hypotheses are proposed:

As previously discussed, Zohar (22) indicated that in factories having successful safety programs there was a strong management commitment to safety. In low accident companies, this commitment was also exhibited when safety matters were given high priority in company meetings and production scheduling based on the conviction that safety is integral part of production systems and accidents are faults in the system. In view of this, the author maintained that managerial safety practices would send a message about priority of safety and this, in turn, would have a significant role influencing treatment errors.

In line with expectancy theory, the following hypothesis is further proposed:

3c. Priority of safety mediates the relationship between managerial safety practices and ICU's clinical incidents.

### Participants and Procedures

This study is a retrospective cross-sectional descriptive and analytical survey. The target population was recruited from the three ICUs in the main tertiary level hospital in Malta: the Intensive Therapy Unit (ITU), the Cardiac Intensive Care Unit (CICU), and the Neonatal Pediatric Intensive Care (NPICU). Inclusion criteria included all full and part-time healthcare professionals (HCPs) working in the previously mentioned ICUs. HCPs include all staff directly involved in patient care and have been working for at least 1 month in the ICU prior to the investigation. HCPs included charge nurses/midwives, practice nurses/midwives, deputy charge nurses/midwives, senior staff nurses/midwives, staff nurses/midwives, consultants, specialist registrars, higher/basic specialist trainees, and physiotherapists. HCPs on maternity or emigration leave were also contacted. A consecutive sample of HCPs who fit the eligibility criteria were asked to participant. Given that this sample reflected the total population of HCPs working within Maltese ICUs, a sample size calculation was not required.

#### Measures

Data were collected through a structured self-administered questionnaire. The "Survey on Patient Safety Climate" was adopted from Naveh et al. (17). Permission to use the tool was sought and granted from Naveh et al. (17). Given that all HCPs either read their undergraduate course in English or were required to be fluent in English to work in Malta, it was deemed unnecessary to translate the questionnaire to Maltese. It was assumed that the English language allowed a good expression of ideas and experiences and prevented language barriers (57). The questionnaire was divided into seven sections: safety information flow, safety procedure suitability, priority of safety, managerial safety practices, clinical incidents observed, background information, and additional comments.

The dimension, safety procedure suitability, was assessed with five items statements originally adapted from Brusson and Jacobsson (58) while safety information flow, was also assessed with five items statements originally adapted from Hofmann and Stetzer (27) and O'Reilly (59). On the other hand, managerial safety practices were assessed with eight items originally adapted from Hofmann and Stetzer (27) and Zohar (54) while priority

3a. Priority of safety mediates the relationship between safety procedure suitability and the ICU's clinical incidents.

3b. Priority of safety mediates the relationship between safety information flow and ICU's clinical incidents.

of safety was assessed with seven items adapted from Zohar (54). Item statements pertaining to each dimension are listed in **Table 1**.

Also, HCPs reported observed clinical incidents over the past 12 months. Four groups of clinical incidents were presented. These included equipment related, such as equipment failure; clinical practice related, such as infection control incidents; pharmaceutical related, such as the administration of the incorrect drug; and administration related, such as delays in patient admission or discharge. The categories of clinical incidents were adopted from Welters et al. (60).

The "Survey on Patient Safety Climate" is a psychometric validated tool having been tested for, face validity, content validity, construct validity, and internal consistency. Naveh et al. (17) did not present evidence of face or content validity. However,

TABLE 1 | Item statements pertaining to each dimension.

#### SAFETY PROCEDURE SUITABILITY

#### SAFETY INFORMATION FLOW

#### MANAGERIAL SAFETY PRACTICES

#### PRIORITY OF SAFETY

the researchers did perform exploratory and confirmatory factor analysis supporting an acceptable degree of construct validity. On the other hand, the author achieved an acceptable degree of face validity through the pilot study. A charge nurse, a deputy charge nurse, a senior staff nurse, a midwife, a consultant, and a physiotherapist who fit the eligibility criteria were asked to complete the questionnaire. Questions and queries were raised and discussed. No modifications were made to the "Survey on Patient Safety Climate" (Sections A–D). However, with regards to Section E titled "Clinical Incidents Observed" the option "non-applicable" was added. Such a modification was deemed necessary as, for example, physiotherapists do not administer pharmaceutical treatment, and are not able to report the perceived pharmaceutical related treatment errors over the past 12 months. With regards to Section F: question 6, the options charge nurse/midwife, deputy charge nurse/midwife and practice nurse/midwife were grouped as charge/deputy charge or practice nurse/ midwife. Similarly, the options Postgraduate Diploma, Masters of Science and Doctor of Philosophy were grouped as postgraduate degrees. Such modifications were deemed necessary to ensure anonymity. The author also achieved an acceptable degree of content validity when a member of Patient Safety and Quality Improvement Team (expert on safety) expressed favorable feedback when asked to review the questionnaire. Also, Naveh et al. (17) and the author derived the coefficient alpha. The coefficient alphas (derived by the author) ranged from 0.847 to 0.867. Given that this is above 0.7, the instrument was deemed reliable as maintained by Nunnally (61).

Permission was sought and granted from the University of Malta Research Ethics Committee prior to data collection. Following ethical approval, permission from the Chief Executive Officer, Data Protection Officer, Director of Nursing and Midwifery Services, Chairman of the Anesthesia Department and the Intensive Care Unit Charge Nurses/Midwives was sought and granted. The participant letter clearly stated that completion and return of the questionnaire indicated willingness to participate and, subsequently a written informed consent was not provided.

#### Data Analysis

The data collected was inputted into the Statistical Package for the Social Sciences (IBM, SPSS) Version 23. For the purpose of this analysis, the scale pertaining to priority of safety was reversed as recommended by Naveh et al. (17). Given that in Malta there are only three ICUs, it was not feasible to analyze data at the work group level. Subsequently, relationships were tested at the individual level only. This was deemed appropriate as all three ICUs provide Level 2 (high dependency) and/or Level 3 (intensive care) care as defined by the Intensive Care Society document Levels of Critical Care for Adult Patients (62). Also, as specified by Luria (63), in order to understand the role of work group level and organizational level practices promoting safety behavior, it is necessary to start with the individual psychological processes of employees.

#### **a) Correlation Analyses**

At the individual level, the relationships between safety procedure suitability and clinical incidents observed (1a) and safety information flow and clinical incidents observed (1b) were investigated using Pearson product-moment correlation coefficient (r). Standard multiple linear regression was performed to identify the best predictor (safety procedure suitability or safety information flow) of clinical incidents observed (64). The F-test was utilized to assess whether the set of independent variables collectively predicted the dependent variable while R-squared, the multiple correlation coefficient of determination, was utilized to determine how much variance in the dependent variable can be accounted for by the set of independent variables (65). The t-test was utilized to determine the significance of each predictor while standardized coefficients beta were used to determine the extent of prediction for each independent variable (65).

#### **b) Mediation Analyses**

At the individual level, the relationships between safety procedure suitability and clinical incidents observed mediated by managerial safety practices (2a) and safety information flow and clinical incidents observed mediated by managerial safety practices (2b) were tested. Also, at the individual level, the relationships between safety procedure suitability and clinical incidents observed mediated by priority of safety (3a), safety information flow and clinical incidents observed mediated by priority of safety (3b) and managerial safety practices and clinical incidents observed mediated by priority of safety (3c) were also tested. As illustrated in **Figure 2**, X is causing the mediator M and M is causing Y.

To test such hypotheses, while the Baron and Kenny (66) approach was consulted, Guillaume (67) maintains that the Baron and Kenny (66) approach does not quantify the indirect effect but infers mediation from a set of hypothesis tests and is prone to Type II error (not detecting an effect when there is one). In view of this, the PROCESS macro approach was conducted, Model 4 was utilized [Simple Mediation Model; (68)] and bootstrapping was employed (67).

A series of regression models were fitted:

III. Finally, the dependent variable was predicted using the independent variables in the absence of the mediator variable (C-path). Therefore, the coefficient beta for A-path, B-path, C' and C-path, and the corresponding p-values were derived.

A measure for the indirect effect of X on Y was presented after the regression model. Therefore, the effect size was reported including limits of the 95% confidence intervals. Mediation occurred when the regression analysis of the independent variable on the dependent variable, controlling for the mediator, was statistically insignificant (67). On the other hand, mediation still occurred when the regression analysis of the independent variable on the dependent variable, controlling for the mediator, is still statistically significant. Some of the effect of the independent variable on the dependent variable would be through the mediator, but there would also be some direct effect (67). Subsequently, the coefficient beta for C' will be less than the coefficient beta for C-path. In view of this, the p-values of the coefficient beta for C' were reviewed. The Sobel's test was conducted to determine the significance of the indirect effect (69). Therefore, the z-values and the corresponding p-values were also derived.

### RESULTS

### Response Rate, Demographic Data and Mean Scores Pertaining to Each Dimension

A response rate of 82.7% was achieved (215/260). 58% of respondents worked in ITU, 32% in NPICU and 10% in CICU. 66.1% were female while 33.9% were male. 70.2% were between 30 and 49 years old, 20.9% were between 18 and 29 years old while only 8.8% were older than 50 years. 44.2% had between 6 and 15 years of experience, 35.8% had between 1 and 5 years of experience, 10.2% had over 15 years of experience while 9.8% had more than 1 month experience but <1 year experience. 86% of respondents worked full-time while 11.6% worked reduced and 2.3% worked part-time. 55.3% of respondents were staff nurses/midwives, 12.1% were specialist registrars, 10.2% were senior staff nurses/midwives, 7.4% were higher specialist trainees, 6.5% were charge nurses/midwives, deputy charge nurses/midwives or practices nurses/midwives, 4.7% were consultants while 1.9% were senior physiotherapists and also 1.9% were basic specialist trainees. Lastly, 55.3% of respondents hold an undergraduate degree while 23.3% hold a postgraduate degree and 21.4% hold a diploma. The mean scores pertaining to each safety climate dimension were as follows: safety procedure suitability: 14.8 (possible range 5–25), safety information flow: 14.3 (possible range 5–25), managerial safety practices: 26.31 (possible range 8–40), and priority of safety: 24.78 (possible range 7–35).

### Correlation Analyses

Findings from correlation analyses (**Table 2**) indicated a small negative correlation between safety procedure suitability and clinical incidents observed (r = −0.269, p ≤ 0.01), with high levels of safety procedure suitability associated with lower levels of clinical incidents observed. Additionally, findings indicated a

#### TABLE 2 | The correlation matrix (\*\**p* ≤ 0.01, \**p* ≤ 0.05).

TABLE 3 | Findings from standard multiple linear regression (\*\**p* ≤ 0.001; \**p* ≤ 0.05).

small negative correlation between safety information flow and clinical incidents observed (r = −0.295, p ≤ 0.01), with high levels of perceived safety information flow associated with lower levels of clinical incidents observed.

Findings from standard multiple linear regression (**Table 3**) indicated that safety procedure suitability and safety information flow collectively predicted clinical incidents observed (Ftest = 11.148, p ≤ 0.001). In the regression model, only safety information flow significantly predicted clinical incidents observed (safety procedure suitability t = −1.356, p = 0.177 vs. safety information flow t = −2.316, p ≤ 0.05).

#### Mediation Analyses

Findings from mediation analyses (**Table 4**) indicated that managerial safety practices mediate the relationship between safety procedure suitability/safety information flow and clinical incidents observed (p = 0.009, 0.014, respectively). Also, findings indicated that priority of safety mediates the relationship between safety procedure suitability/safety information flow/managerial safety practice and clinical incidents observed (p = 0.002, 0.002, 0.042, respectively).

 The tested theoretical framework is portrayed in **Figure 3**.

#### DISCUSSION

#### Safety Procedure Suitability and Safety Information Flow

Within Maltese ICUs, findings indicated that to a moderate extent, employees perceived safety rules and regulations suitable for the daily activities of the unit, available as written policies or procedures, relevant to the work, detailed enough, and practical (17). Also, to a moderate extent employees perceived safety rules and regulations are updated regularly and presented in a simple TABLE 4 | Findings from mediation analyses.

*1. The indirect effect of safety procedure suitability on clinical incidents through the mediator, managerial safety practices.*

*2. The indirect effect of safety information flow on clinical incidents through the mediator, managerial safety practices.*

*3. The indirect effect of safety procedure suitability on clinical incidents through the mediator, priority of safety.*

*4. The indirect effect of safety information flow on clinical incidents through the mediator, priority of safety.*

*5. The indirect effect of managerial safety practices on clinical incidents observed through the priority of safety.*

and understandable format. Additionally, to a moderate extent employees felt that they are informed about potential hazards, safety-training programs are available while information about safety is distributed regularly (17).

In agreement with previously mentioned research studies, findings indicated a small negative correlation between safety procedure suitability/safety information flow and clinical incidents observed (r = −0.269, p ≤ 0.01; r = −0.295, p ≤ 0.01, respectively), with high levels of safety procedure suitability/safety information flow associated with lower levels of clinical incidents observed. According to Goodwin and Leech (70), a number of factors may have possibly affected the size of the correlation. Factors include: the amount of variability in either variable, differences in the shapes of the two distributions, lack of linearity in the relationship, the presence of one or more "outliers" in the dataset, characteristics of the sample used and measurement error. Despite this, it is important to note that the correlations were strongly statistically significant.

Findings from standard multiple linear regression, indicated that safety procedure suitability, and safety information flow collectively predicted clinical incidents observed (F-test = 11.148, p ≤ 0.001). However, in the regression model, only safety information flow significantly predicted clinical incidents observed (safety procedure suitability t = −1.356, p = 0.177 vs. safety information flow t = −2.316, p ≤ 0.05). These findings may possibly reflect the large correlation between safety procedure suitability and safety information flow (r = 0.694, p ≤ 0.01). Therefore, the variables are said to be collinear (71). Collinearity may cause problems in fitting and interpreting regression models, because the inclusion of two highly correlated variables in a regression model may give the impression that neither is associated with the outcome, even when each exposure is associated (individually) with the outcome (71).

Findings support congruency theory. Within an intensive care setting, findings from Pronovost et al. (72) indicated that the implementation of the central venous catheter (CVC) care bundle resulted in a large reduction of CVC infections (up to 66%) during the 18-months study period. However, findings from this study indicated that it is not simply the implementation of safety procedures that results in safety performance but it is the fact that employees deem safety procedures as suitable and subsequently comply with safety procedures. This is supported by findings from Resar et al. (73), which indicated that ICUs with the highest level of bundle compliance had the highest rate of infection reduction. Findings from this study also indicated that safety procedures must be accompanied by safety information flow, which is deemed clear and unambiguous. This is supported by evidence from Hawe et al. (74) who, designed and implemented a ventilator-associated pneumonia (VAP) prevention bundle in a medical and surgical ICU. The bundle was implemented, first passively then actively. Active implementation involved education, feedback of process and outcome measurements amongst other interventions. Subsequently, the active (rather than passive) implementation was associated with a significant improvement in VAP bundle compliance and decreased incidence of VAP.

#### Managerial Safety Practices

Within Maltese ICUs, employees perceived that managers in their unit occasionally gave praise when s/he saw a job done according to safety rules, occasionally approached employees during work to draw attention to safety issues and occasionally approached employees who violate safety rules (17). Employees also perceived that managers in their unit occasionally committed to adhering to safety rules and procedures while occasionally considered safety when evaluating performance and/or in promotion considerations (17). Employees also perceived that managers in their unit occasionally got annoyed with workers who ignored safety rules and regulations and occasionally created an atmosphere in which people can say whatever they think (17).

In agreement with previously mentioned research studies, findings support the hypotheses that managerial safety practices mediate the relationship between safety procedure suitability/safety information flow and clinical incidents observed global (p = 0.009, p = 0.014, respectively). Findings support social learning theory. Such findings reflect the fact that when employees deem safety procedures as suitable and safety information flow as clear and unambiguous, managers receive messages that safety is important within the unit. This translates to managers' practices that emphasize safety. Therefore, the more employees perceive managerial safety practices as high, the more employees will learn about safety behavior (compliance and participation), and consequently less clinical incidents will occur. This is because managerial behavior provides cues regarding workplace norms and which kind of behavior is likely to be supported, valued or rewarded (75).

Interestingly, Zohar and Polachek (41) distinguish between sent and received role expectations and highlight the fact that this distinction is especially important when such expectations relate to priorities associated with competing role facets (41). Subsequently, when conflict arises between priority of safety and pressure for production, employees look at their managers for cues to guide their safety behavior (75). The assessment of priorities requires an interpretive sense making process on behalf of employees stemming largely from the difficulty of untangling and discriminating between espoused and enacted priorities (41). Espoused priorities refer to formal organizational safety policies by upper management while enacted priorities refer to the actual implementation and execution of safety procedures among employees (76). Therefore, employee perceptions essentially depend on received role expectations from enacted priorities rather than sent role expectation from espoused priorities (41). In addition to this, Zohar and Polachek (41) also emphasize the fact that changes in the content of received role expectations must remain stable and consistent offering sufficient opportunities for employees to experience and validate it as a real (rather than espoused) change (41). Changes in the content of received role expectations must be experienced in routine and daily leadermember exchanges rather than reserved to formal occasions, offering multiple opportunities for testing managerial enactment of espoused priorities (41). Consequently, a change of safety climate requires repetitive evidence indicative of sustained managerial prioritization of safe performance in the context of daily events or work situations presenting competing operational demands and it is this stability, which implicates genuine commitment to safety (41).

### Priority of Safety

Within Maltese ICUs, employees perceived that occasionally in order to get the work done, one must ignore some safety aspects, and whenever pressure builds up, the preference is to do the job as fast as possible even if it means less safety (17). Furthermore, employees perceived that occasionally human resource shortages undermine safety standards and occasionally safety rules and procedures are nothing more than a cover-up of lawsuits (17). Also, employees perceived that occasionally safety rules and procedures are ignored and occasionally ignoring safety is acceptable (17). In addition to this, employees perceived that occasionally it does not matter how the work is done as long as there are no accidents (17).

In agreement with previously mentioned research studies, findings support the hypotheses that priority of safety mediates the relationship between safety procedure suitability/safety information flow/managerial safety practices and clinical incidents observed (p = 0.002, p = 0.002, p = 0.042, respectively). Findings support expectancy theory. Findings reflect the fact that safety procedure suitability/safety information flow/managerial safety practices influence the priority of safety within the organization. Therefore, according to Naveh et al. (17), when safety procedures are deemed unsuitable employees deem priority of safety low within the unit. This is because complying with such procedures requires extra time and effort at the expense of speed and productivity. Subsequently, this situation calls for a trade-off between safety and productivity. Furthermore, according to Naveh et al. (17) an organization, which invests in safety training sessions and safety information distribution, sends the message to employees that not only productivity is important but that safety is also a central issue. Subsequently, employees should invest time and effort to maintain safety. Also, according to Naveh et al. (17), managers set the tone and tempo for the priority of safety by emphasizing specific safety behaviors and undermining others, by enforcing safety and by recognizing employee safety behavior.

### Under What Circumstances Are Managerial Safety Practices and Priority of Safety Critical for Safety Performance?

It is not only important to understand why managerial safety practices and priority of safety are critical for safety performance, but also under what circumstances are they critical for safety performance. Findings from Katz Navon et al. (18) and Bosak et al. (75) indicated that when priority of safety was high the impact of managerial commitment to safety on treatment errors or employees' risk behavior was nullified. Findings from Katz Navon et al. (18) indicated that employees received enough cues regarding the importance of safety within their unit via their understanding of priority of safety. However, Bosak et al. (75) found this effect only for conditions where employees experienced low levels of pressure for production. However, under conditions where employees experienced high levels of pressure for production, management commitment to safety was influential regardless of high vs. low priority of safety. Therefore, when conflict exists between pressure for production and priority of safety employees look at their manager for cues to guide their safety behavior. As managers have a direct bearing on the jobs and allocated rewards of employees, the likelihood of employees to engage in risk behavior is reduced when their manager is highly committed to safety despite a high demand for work place productivity.

Interestingly, findings from Hofmann and Stetzer (25) supported the hypothesis that role overload (pressure for production) was positively associated with the tendency to engage in unsafe acts (for example, adopting "short-cuts"). Also, findings from Hofmann and Mark (38) supported the hypothesis that patient complexity (pressure for production) moderated the relationship between safety climate (conceptualized as job duties allow for safe performance, social standing, management's attitude toward safety) and nurse back injuries and medication errors. In fact, the Francis Inquiry Report into the Mid-Staffordshire National Health Service Foundation Trust highlights the impact of staffing cuts on patient care (13). Inadequate staffing levels and staff workload (increased pressure for production) have been identified as key variables determining outcomes such as hospital mortality rates (77) and prolonged length of stay (78).

### Strengths and Limitations

This study adds value to patient safety literature. First, because the author did not simply measure the level of safety climate but approached the topic analytically. Second, because the author reviewed literature from various industries (for example metal processing plants, the food and beverage industry, the shipping industry) so as to gain "valuable insight about how to begin the process of improving the safety of healthcare" as advised by the Teuma Custo et al. Safety Climate and Performance

IOM report [(10), p. 159]. Third, findings are representative of Maltese ICUs because the sample included the total population of HCPs working within Maltese ICUs and achieved a high response rate. However, given that this study included ICUs from Malta only, the ability to extrapolate findings is limited. Other limitations must be given due consideration. First, a cross sectional design was adopted and therefore it is difficult to differentiate between cause and effect from simple association (79). Also, reverse causality cannot be ruled out (42, 80). Second, given that throughout the years different researchers have conceptualized safety climate differently (44), the theoretical framework hypothesized and tested may be more complex. Third, a test-retest reliability procedure was not conducted to establish the stability of the tool. This is important as findings are at risk of acquiescence response bias, mood bias, non-response bias, social desirability bias as well as recall bias (81).

#### Recommendations

Based on findings, health service managers are recommended to ensure employees perceive safety procedures as suitable and safety information as clear and unambiguous. This may be achieved by, for example, regularly assessing employees perceptions, regularly updating safety procedures in line with up-to-date evidence, encouraging discourse about safety, and/or using technology to improve access to safety information (for example: creating an app to easily access protocols or introducing clinical information systems to facilitate reminders and/or alerts). It is advisable that the managers receive safety training, which emphasizes their role as a safety referent (82), moving beyond safety policy formulation to that of a safety change agent (75). Also, managers are recommended to ensure safety is prioritized over work pace, workload and pressures for production. This may be achieved through the creation of a psychological contract between managers and employees which reflects the fact that safety behavior, is a behavior that is supported, valued, and rewarded (83). Essentially, managers must create good safety leaders who speak of safety, act safely at work, focus on maintaining safety standards, engage others in safety initiatives and recognize individual who adhere to safety (84). Along these lines, good safety leaders must engage in continuous quality improvement such as plan-do-study-act cycles and risk management (85).

Given that the cross-sectional design of this study makes it difficult to conclude whether safety climate is a lagging or leading variable, a longitudinal design is needed to strengthen the ability to infer causality. Future research should also identify and investigate other safety climate dimensions such as pressure for production (75), teamwork (86), non-punitive response of error (87), safety training (44), safety consciousness (29), and safetyspecific leadership (48). A qualitative design or even a mixed method approach, such as triangulation may be adopted in an attempt to measure safety culture rather than climate (24, 88, 89). Future research should extend this study to other healthcare settings and analyze data at the work group, rather than at the individual level. However, in order to aggregate data from the individual level, the work group must have a strong safety climate (homogeneity of safety climate perceptions) (9). Essentially, future research should test a multilevel model of safety climate (31). Future research should investigate safety performance expressed as objective reliable variables such as incidence of ICUacquired blood stream infections, ICU-acquired pressure ulcers and VAP. Lastly, future research should develop valid and reliable tools measuring safety behavior in terms of patient safety.

### CONCLUSION

This study enabled a better understanding of the relationships among patient safety climate dimensions and their impact on safety performance. This is important to gain better insight on how to manage in non-routine work environments (17) and shed light on the fact that managers need to move beyond formal aspects to ensure safety (18). This study emphasized the significance that employees perceive safety procedures as suitable, safety information flow as clear and unambiguous, managerial practices as emphasizing safety and safety is prioritized over work pace, workload, and pressure for production. Conclusively, this study adds value to patient safety literature, providing groundwork for future research.

### DATA AVAILABILITY STATEMENT

The datasets generated for this study are available on request to the corresponding author.

### ETHICS STATEMENT

Permission was sought and granted from the University of Malta Research Ethics Committee prior to data collection. The participant letter clearly stated that completion and return of the questionnaire indicated willingness to participate and subsequently a written informed consent was not provided.

### AUTHOR CONTRIBUTIONS

PT and SB developed the hypotheses and proposed theoretical framework, adopted the Survey on patient safety climate, PT recruited participants, collected data and conducted analysis including correlation and mediation analysis. SB supervised the research. PT, RT, and SB co-wrote the manuscript. All authors approved final manuscript.

### FUNDING

The publication of this article was possible due to the Frontiers Waiver Program. The authors would like to thank Frontiers for supporting this publication. No other funding can be reported.

### ACKNOWLEDGMENTS

We would like to acknowledge that this manuscript is based on the dissertation titled Patient safety climate in Maltese intensive care units completed by PTC (90). The dissertation was submitted in partial fulfillment of the requirements for the Masters of Science in Health Service Management, Department of Health Services Management, Faculty of Health Sciences, University of Malta. Also, we would like to thank all healthcare professionals working in the intensive care units who took time to participate in this study and the management who encouraged participation, helped coordinate the distribution, and collection of questionnaires. Lastly, expert advice by

#### REFERENCES

Vincent Cassar and Dorothy Gauci is greatly acknowledged and highly appreciated.

### SUPPLEMENTARY MATERIAL

The Supplementary Material for this article can be found online at: https://www.frontiersin.org/articles/10.3389/fpubh. 2019.00302/full#supplementary-material

**Conflict of Interest:** The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Copyright © 2019 Teuma Custo, Teuma Custo and Buttigieg. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

# The Impact of the Socio-Demographic Characteristics of Complementary and Alternative Medicine Users in Serbia on OTC Drug Consumption

#### Marina Luketina-Sunjka1 \*, Nemanja Rancic2 , Natasa Mihailovic3 and Mihajlo Jakovljevic4

*1 European Center for Peace and Development, University for Peace established by the United Nations, Belgrade, Serbia, 2 Faculty of Medicine of the Military Medical Academy, Centre for Clinical Pharmacology, University of Defense, Belgrade, Serbia, 3 Department of Biostatistics and Informatics, Institute of Public Health Kragujevac, Kragujevac, Serbia, 4 Division of Health Economics, Lund University, Lund, Sweden*

#### Edited by:

*Sandra C. Buttigieg, University of Malta, Malta*

#### Reviewed by:

*Ana Sabo, University of Novi Sad, Serbia Brian Godman, Karolinska Institute (KI), Sweden*

> \*Correspondence: *Marina Luketina-Sunjka<EMAIL_ADDRESS>
#### Specialty section:

*This article was submitted to Health Economics, a section of the journal Frontiers in Public Health*

Received: *19 July 2019* Accepted: *04 October 2019* Published: *24 October 2019*

#### Citation:

*Luketina-Sunjka M, Rancic N, Mihailovic N and Jakovljevic M (2019) The Impact of the Socio-Demographic Characteristics of Complementary and Alternative Medicine Users in Serbia on OTC Drug Consumption. Front. Public Health 7:303. doi: 10.3389/fpubh.2019.00303* The Aim of this research is to analyze how the socio-demographic characteristics of users of Complementary and Alternative Medicine (CAM) in Serbia influence and impact their consumption of OTC drugs. Respondents and methods: The study employed the third edition of the National Health Survey of the Republic of Serbia, published in 2013, as a data source covering the Serbian population. The sample comprised of 550 interviewed individuals who had been applying a variety of CAM treatments over the previous 12 months. Their socio-demographic characteristics were used as independent variables impacting the consumption of OTC drugs over the previous 2-week period, representing the dependent variable.

Results: Two thirds (65.3%) of the CAM users consumed OTC drugs at their own discretion, without recommendation by a physician or a relevant prescription. Users of OTC drugs were most often females whose ages ranged within the average interval of 49.16 ± 16.02, whose education level was to secondary school diploma, who were married and employed, lived in urban areas, mostly Belgrade, belonged to the middle-income group, and followed relevant headlines via public information channels (TV, the internet, radio, and print). Comparison of the results revealed, on the one hand, that 2/3 of respondents who had used and 1/3 of those who did not consume OTC drugs had undergone fecal occult blood tests over the past year (*p* < 0.05) and, on the other hand, that those respondents had been less frequently hospitalized in the previous year (*p* = 0.05). In addition, the same responders were found to access available health care services more frequently than did others (*p* < 0.05).

Conclusion: Since, according to the statistics, it is highly likely that respondents who were CAM- and OTC drug-users would be less frequently hospitalized and not use medical leave, these results provide a strong indication that this phenomenon should be investigated in more depth. Moreover, the areas to be considered when defining strategies for determining patient treatments should also include the influence of socio-demographic factors on the patient's consciousness that would enable easier understanding of the proper usage of OTC drugs.

Keywords: CAM, complementary and alternative medicine, OTC drugs, socio-demographic factors, national health survey, health care

#### INTRODUCTION

Complementary and Alternative Medicine (CAM) has attracted global interest in both developed and underdeveloped countries (1). During the past several decades, post-industrial societies have been characterized to have a "blooming" prevalence and incidence of so-called "prosperity diseases," i.e., chronic noninfectious diseases. In 2016, the WHO reported that out of 56.9 million deaths worldwide, one-third were caused by ischemic heart disease and stroke. In the past 15 years, cardiovascular diseases have been determined to be the leading cause of death globally (2). Moreover, chronic non-infectious diseases have also been recognized as causing the majority of deaths in Serbia (3). This phenomenon has seriously put to the test the availability and limits of so-called Conventional or Science Medicine. Facing such long-term challenges, in May 2009, the WHO Assembly adopted Resolution 62.13, which calls on all member states and governments to cooperate and share knowledge while simultaneously working on strengthening bonds between conventional and traditional practitioners (4). In most Balkan countries, the introduction of legislation for the development of medicine was interrupted by the civil war that took place in the 90s (5), and this continued through the country's transitional period (6). CAM development also suffered: only in 2007, rather late when compared to other European countries, did the Ministry of Health of the Republic of Serbia enable the introduction of Complementary and Alternative Medicine, to be practiced by health workers only (7).

The abbreviation "OTC" stands for "Over the Counter," and such drugs are medicines that require no prescription. Research shows that 81% of adults in the USA practice taking OTC drugs as a **first** reaction to a minor health condition (8). A household in the USA, on average, spends about 442 USD on OTC drugs per year (9). As per the results of a systematic review covering 27 studies aiming to calculate the proportion of CAM users within the population of cardiovascular patients, the prevalence of CAM consumption was recorded to be between 22 and 68%; 2–46% consumed herbal medicines, 3–54% consumed vitamins, minerals, and other dietetic supplements (mostly Vitamin B12 or Vitamin B complex, Vitamin C, Vitamin E, Chondroitin Glucosamine, Coenzyme Q10, Calcium, and Magnesium) (10).

Globally, CAM budgets vary significantly, and comparisons are complex firstly due to the different currencies used, secondly because there is no standardization, causing CAM definitions and categorizations to differ, and thirdly because different research time intervals have been used (11). For these reasons, the comparison of OTC use data among populations is complicated.

Based on a National Population-Based Survey in Australia conducted on CAM users, it was noted that 621 million AUD (12) was paid for CAM out-of-pocket in 1993, 1671 million AUD in 2000 (13), 1308 million AUD in 2004 (14), and 1860 million AUD in 2005 (15). In 1990, US citizens spent 10.3 billion USD out of their own pockets (16, 17), in 1997 they spent 34.4 billion USD (18, 19), in 2007, 33.9 billion USD (20, 21), and in 2012, 30.2 billion USD (22). In the UK, a systematic review of studies researching CAM usage prevalence determined that monthly expenses per patient amounted to 15.99 GBP (23). In 1999, the estimated expenses reached 1.6 billion GBP in the UK (24).

The Serbian health care system is funded by both public finances and private contributions (25). About 69% of total current health expenditure is financed by public sources, and more than 90% of public sources are financed through the Republican Health Insurance Fund (26, 27), with supplementary funding from budgetary sources (the Ministry of Finance Fund for the Unemployed, the Pension Fund, etc.) Private funding is completely based on out-of-pocket payments (28), and it is supplemented by contributions from companies that fund their own institutions that specialize in the treatment of occupational diseases and provide primary care services.

The aim of this particular research was to determine which factors impact the usage of OTC drugs among the CAMusing population, or in other words, besides considering health conditions, financial status, lifestyle, the presence of chronic illnesses, and other factors have been included in our observations, as these may contribute to the occurrence of simultaneous usage of CAM and OTC drugs.

#### MATERIALS AND METHODS

The most recent health research data on the population of the Republic of Serbia were used for this research. It is from a crosssectional study run by the Ministry of Health of the Republic of Serbia throughout 2013.

In the research, interviews were used, and a horizontal approach was taken, enabling the collection of more personalized data from a single individual (health condition, whether they accessed health care services, habits, and lifestyle). The questions and indicators used in the questionnaires were standardized to those adopted by the European Union, in addition to using indicators standardized to those in the "Health For All" database of the WHO or recommended to become EU indicators (29, 30).

Surveys were conducted as a cross-sectional study. The population presented in the research included adults aged 19 and over. Individuals living in care institutions (elderly care homes, prisons, and psychiatric institutions) and in Kosovo and Metohija were not included in the research. The research used a national representation sample, which is a stratified two-phase sample without repetition. The sample frame in the research included all the households listed in censuse to 2011. In order to obtain a random sample, two techniques were used: stratification and multiple-phase sampling. Stratification was conducted in such a way that each of four geographical areas (Vojvodina, Belgrade, Sumadija and west Serbia, and south and east Serbia) represented one main stratum in the sample. Each stratum was divided into cities and other regions. The total number of strata was eight. Two-phase sampling included local communities, selected on the basis of probability proportional to their size, and households as units of the second phase selected on the basis of the linear sampling method with a random start and uniform selection steps. All respondents that had used CAM (acupuncture, homeopathy, phytotherapy/herbal therapy, or chiropractic) over the previous 12 months and were living in the Republic of Serbia were extracted from this database, totaling 550.

Individuals living in care institutions (elderly care homes, prisons, and psychiatric institutions) and in Kosovo and Metohija were not included in the research. The principles of ICH Good Clinical Practice were followed strictly, and approval was obtained from the Ethics Committee of the Republic of Serbia. The research used data from the Third National Health Survey of Serbia, sponsored by the Ministry of Health's Batut Institute, which provided data to the faculty for the purpose of additional research. The Ethical Standards for Healthcare Research are aligned with the International Medical Association Declaration of Helsinki and legislation specific to the laws of Serbia. Aiming to align with GDPR policies to preserve the discretion of the respondent data collected, all steps were adopted that are stipulated by the law on the protection of personal data (Official Gazette of the Republic of Serbia No. 97/08, 104/09), the Official Statistics Law (Official Gazette of the Republic of Serbia No. 104/09), and Directive 95/46/EC of the European Parliament on the protection of individuals with regard to the processing of personal data and on the free movement of such data (31).

#### Statistical Methods

Continuous variables were presented as mean ± standard deviation, and categorical variables as frequency (n) and percentage (%). The Chi-square test, representing the univariant method, was used for categorial data, and the Students' ttest was used for continuous data. Factor analysis was applied as the multivariant technique. The following variables were analyzed through factor analysis: sex, age, education, region, accommodation, work status, well-being index, health selfevaluation, commitment to being healthy, record of chronic disease, medical leave, hospitalization, visits to day-care hospitals, home medical care and Emergency Room Assistance in the past 12 months, consumption of OTC drugs over the previous 2 weeks, risky behavior, routine checks and screening for colon cancer, and health care non-utilization (communalities higher than 0.2). All analyses were performed using SPSS, version 19.

#### RESULTS

In Serbia, two-thirds (65.3%) of CAM users consume OTC drugs at their own discretion, neither due to a physician's recommendation nor through prescription. OTC drug consumers are most frequently females with an average age of 49.16 ± 16.02, possessing a high-school diploma, married and employed, most frequently living in urban areas, mostly Belgrade, categorized as middle-income as per the "wellbeing index," and who follow health topics via publicly available information (TV, the internet, radio, and print).

By comparing the basic socio-demographic characteristics of respondents that consume and that do no consume OTC drugs, it is evident that the consumers are mostly females (Chi-square test = 9.87, df = 1, p < 0.05) and that OTC consumers are, on average, 4.5 years older than those that do not use OTC drugs (t = −3.06, df = 548, p < 0.05).

There was no statistically significant difference in the use of analgesics with respect to gender, educational attainment, region and place of residence, self-evaluation of health status, presence of chronic health disorders, and long-term illness. On the other hand, individuals falling into the middle-income category more often consume analgesics at their own discretion (Chi-square test = 8.72, df = 2, p < 0.05), while this practice is rarest among respondents living in the Belgrade region (Chi-square test = 8.68, df = 3, p < 0.05).

The consumers of OTC drugs mostly evaluate themselves as being in good health, i.e., average, and, even though they are in the habit of risky behavior, have usually never undergone screening tests for colon cancer. Of those respondents, 56% suffer from chronic health disorders and visit health care institutions more frequently than others. Mostly, the users of OTC drugs had not taken any medical leave, been hospitalized, or used day-care hospitals, emergency assistance, or home medical care over the preceding 12 months (**Table 1**).

Comparison revealed that two-thirds of respondents that had consumed and one-third of those that had not consumed OTC drugs had undergone fecal occult blood tests over the previous year (Chi-square test = 6.37, df = 2, p < 0.05) and that those respondents had less frequently been hospitalized over the previous 12 months (Chi-square test = 3.67, df = 1, p = 0.05) (**Table 1**).

One-third of OTC drug users who were not able to utilize the required healthcare services, which could be due to a number of factors, such as waiting lists, financial insolvency, or perhaps the distance to the required healthcare institution, were employed. Our research, as well as numerous other studies, showed that fear of losing an existing job could be one of the reasons why employed individuals consume OTC drugs (32).

OTC drug users most often rated their own health as good or average, but despite risky behavior, they had generally never undergone screening for colon cancer. Of those respondents, 56% had chronic health disorders and most often utilized the required form of health care. Most OTC users did not take sick leave and had less frequently been hospitalized or used a day hospital,

\**over previous 12 months;* # *Chi-square test.*

ambulance, or home treatment in the previous 12 months than had others (**Table 1**).

Most common drugs, herbal supplements, and/or vitamins that the respondents were taking on their own, without prior consultation with a physician, were bought in pharmacies and are presented in **Figure 1**.

Principal component analysis (KMO = 0.715, p < 0.01) isolated six factors that explain 53.79% of the variance: Health Condition (17.43% of the variance), Financial Status (10.16% of the variance), Age (7.89% of the variance), OTC Drugs (7.42% of the variance), Risk (6.21% of the variance), and Health Care Utilization (5.94% of the variance).

The health condition factor groups together the variables health self-evaluation, the existence of chronic disease, and limits to daily activities due to the disease, showing that individuals that suffer from chronic diseases that prevent them from undertaking daily activities evaluate their health as bad. The health condition factor included in the factor analysis also implied the presence of chronic disease (**Table 2**). There was no statistically significant difference in the use of OTC drugs with respect to the presence of a chronic health disorder, such that 64.4% of those who had and 67.3% of those who did not have a chronic illness used OTC products (Chi-square test = 0.29, df = 1, p > 0.05).

Similarly to our research, other studies have shown that the use of certain drugs reduces the rate of hospitalization in adults (33). Antiplatelet, diuretic, and non-steroidal antiinflammatory drugs and anticoagulants are medicines that reduce hospitalization rates (34).

The financial status factor groups five variables: region, accommodation, well-being index, education, and health care non-utilization. This factor shows that individuals living in urban areas in the Vojvodina area, possessing a higher/high degree of education, and classified as very rich as per the well-being index, have never managed to access required health care services due to long waiting lists.

The age factor groups the variables age and employment status and shows that the oldest respondents were retired.

The OTC drugs factor groups four variables: sex, awareness about health topics, OTC drug use, and hospitalization in the previous 12 months. This factor shows that women who were aware of topics related to health and that had consumed OTC drugs over the previous 12 months had not been hospitalized.

The emergency assistance factor, which groups variables related to using emergency assistance in the previous 12 months and risky behavior, showed that already ill patients had been using emergency medical services during the previous 12 months.

The factor explaining health care utilization groups variables such as the selection of a private practice physician and being a day-patient over the previous 12 months. This shows that respondents who had selected a private practice physician TABLE 2 | Principal component analysis.

were hospitalized fewer times for additional diagnosis/treatment ("Day patient") (**Table 2**).

• Analysis of female respondents aware of health topics via public information systems

The majority of females (71.1%) that followed health topics via public information systems had consumed OTC drugs over the past 2 weeks. Most commonly, they had a high-school diploma. However, 37.2% of females characterized as having a higher/high education level had also used such drugs, while 26.1% of those at the high-school education level had not (Chi-square test = 8.24, df = 2, p < 0.05). Every third female in the Vojvodina region had consumed OTC drugs over the previous 2 weeks, while every fourth female from the Sumadija and West Serbia regions had not (Chi-square test = 9.02, df = 3, p < 0.05). OTC drugs had been consumed by 56.7% of females following health topics in addition to having risky behavior. Simultaneously, 39.7%, though wellinformed on health issues and acting riskily, had not consumed such drugs (Chi-square test = 6.22, df = 2, p < 0.05). Further analysis of the female respondents that consumed OTC drugs and followed health-related topics via public information systems (the internet, TV, print, and radio) shows that these respondents had statistically significantly been hospitalized fewer times over the previous year when compared to respondents not using OTC drugs (Chi-square test = 7.98, df = 1, p < 0.05). Although those female respondents had not accessed any health care services, there was no significant statistical difference in the usage of OTC drugs among respondents following health topics.

• Analysis of male respondents following health topics via public information systems

Every second respondent (55.3%) following health topics had consumed OTC drugs over the previous 2-week period. The users of OTC drugs were mostly high-school graduates. No significant statistical difference was found among users of OTC drugs that followed health topics and had different levels of education (p > 0.05). OTC drugs were mostly used by males living in the Belgrade region (38.6%) and less so by males from the regions of Sumadija and West Serbia (8.8%) (Chi-square test = 8.13, df = 3, p < 0.05). No statistically significant difference was found between OTC usage and risky behavior (p > 0.05). Among the observed males, no statistically significant difference was found between the use of OTC drugs and hospitalization over the previous 12 months. Of male respondents, 47.8% had neither utilized health care services nor used OTC drugs.

#### DISCUSSION

In Serbia, as per our local research, two-thirds (65.3%) of CAM users consume OTC drugs at their own discretion, without either a recommendation from a physician or a prescription. These are mostly females of an average age of 49.16 ± 16.02 with a highschool diploma, married and employed, most frequently living in urban areas, mostly Belgrade, classified as of the middle-income class, and following health topics via public information systems (TV, the internet, radio, and print). Most studies that have been undertaken significantly predict that CAM users will be females and interpret this to be the result of their having more frequent communication with their friends and families about their health condition and having been given diagnoses that turned out to be a significant source of information (23, 35–43). However, there are some studies indicating situations where males turned out to be the majority of consumers in cases where they were suffering from, e.g., gout and arthritis (44).

Our data analyses show that the predominant OTC drug users were females with a high-school diploma and also 37.2% of females with a higher/high education diploma, though 19.2% of such females did not use OTC drugs. Globally, the significant predictors in the majority of studies conducted to date point to CAM users being characterized by a high income and vocations requiring a high level of education. The explanation made for this may lie either in the fact that they were financially able to use CAM or in the fact that CAM users are highly educated and hence question the efficiency of conventional medicine (11, 37– 40, 42–45). One study that covered Europe pointed out that the variables of being female and having a higher education level are significant socio-demographic characteristics in CAM usage, while other variables varied depending on the CAM type (36).

Worldwide, health condition and health perception, among selected socio-demographic factors, have been found to be significant in making a decision regarding whether an individual would use CAM and OTC, especially when the condition or the individual's perception of their health was described as bad (34, 36, 42). The OTC users in our research mostly perceived their health as good, i.e., average, and though practicing risky behavior, they had almost never undergone Ca colon cancer tests. Fifty-six percent of these types of respondents suffer from chronic diseases and mostly utilized the required health care services. Worldwide, as per different studies, patients suffering from chronic diseases or some form of disability (35) and other more challenging types of disease (40, 46, 47), decided to use CAM and OTC drugs very frequently due to a lack of expected effects from conventional medicinal treatments or due to the nonavailability of a General Practitioner (36). A systematic review of 18 studies in nine countries observing the use of CAM in the diabetic patient population, where prevalence varies from 17 to 72% (average 45%), determined that dietetic supplements, herbal medicines, nutrition consultations, spiritualism, and relaxing techniques were the methods most frequently applied (46). A review of six studies in Saudi Arabia showed the prevalence of CAM use among diabetic patients to be 32.18% and that herbal medicines were most commonly used (47). The most common types of medicines in our research were herbal medicines and/or vitamins that were consumed by the patients on their own, without previous consultation with a physician, and were bought in pharmacies.

In Serbia, according to the Medicines and Medical Devices Act, the advertisement of medicines and medical devices is prohibited, that is, the information that is advertised on a medicinal product or medical device must be true and scientifically proven, cannot mislead the professional and general public, and must be in accordance with the Regulation on the Advertising of Medicines and Medical Devices (48). However, advertising is allowed for OTC drugs. Based on research conducted among students in Poland, we learned that the advertising of OTC drugs is allowed there and is on the rise (49). Interestingly, in both Poland and our research, the largest portion of OTC consumers were females (49). The statistics show that females in Serbia follow health-related topics via the media (TV, the internet, radio, and print), like the females in Poland, but that females were more attentive and less influenced by advertising (49).

Thanks to the research undertaken in Serbia (January 2010– July 2011), pioneering efforts have been made that have resulted in an understanding of the weaknesses in the perceptions of the current and future health workforce toward CAM. It included a questionnaire based on the existing CAM Health Belief Questionnaire (CHBQ), using the Likert scale, where 797 health students and practitioners were interviewed. Students of Dentistry (54.65 ± 6.07) were better informed on CAM therapies than students of Medical Science (50.26 ± 7.92) and students of Pharmacy Science (51.16 ± 7.10). Physicians achieved better results than university professors (55.12 ± 6.55 vs. 50.29 ± 9.50). Furthermore, all of the respondents gave priority to the use of vitamins over any other CAM therapy. In general, consciousness of the use of CAM is increasing in the Balkans (50).

Systematic literature review (42 studies) has found that the prevalence of CAM use ranged from 8 to 90% in patients with prostate cancer (39). A systematic review of four studies on the population of patients with colorectal cancer showed that up to 75% of them used at least one CAM method (51). The most commonly used CAM methods were biologically based therapies: herbal remedies (48.7%), homeopathy (20.5%), vitamins/minerals (17.9%), medical teas (15.4%), and mind and body medicinal procedures such as spiritual techniques (15.4%) and relaxation techniques (12.8%) (51). According to the results of a systematic review of 49 studies on the use of CAM in patients with arthritis in 12 countries, dietary supplements and massage were the most frequently used (43). For Parkinson's patients, the estimated prevalence of CAM use was found to range from 25.7 to 76%, with the most commonly used CAM methods being massage in the United Kingdom, acupuncture in Sweden and Argentina, vitamins and herbal remedies in the United States, traditional medicine in Singapore, and oriental medicine in South Korea (44).

## CONCLUSION

The analysis of socio-demographic factors and their influence on the proper selection of OTC drugs should become a very significant part of the processes conducted in order to define strategies for determining the treatments for particular patients. The research statistics presented here strongly support OTC drugs correlates with an absence of hospitalization, absence of medical leaves, and absence of day-care hospital, emergency assistance, or home medical care usage in the previous 12 months. Furthermore, wider research focusing on the aforementioned factors should enable the improvement of treatment strategies for enhancing patients' well-being.

In addition, although global research indicates growing trends, the actual evidence for the use of CAM methods in Serbia is very poor. In order to enable a comparison of health care service utilization and CAM methods, it would be necessary to take a different approach. This new path would rely on the Ministry of Health of the Republic of Serbia taking a leading role, due to their better understanding of this matter.

### DATA AVAILABILITY STATEMENT

Publicly available datasets were analyzed in this study. This data can be found here: https://ec.europa.eu/health/indicators\_data/ indicators\_el; https://ec.europa.eu/health/indicators\_data/echi\_ en; http://www.healthpowerhouse.com.

### AUTHOR CONTRIBUTIONS

ML-S and MJ jointly designed the study and defined the research questions. NM and NR did most of the data mining and extraction, purification of files for missing data and artifacts, and statistical analysis. NM, NR, and ML-S contributed to table and figure creation and interpretation of data. ML-S, MJ, and NR drafted the working version manuscript. All authors contributed to the final version to the extent of important intellectual content.

### FUNDING

This work was supported the Ministry of Education, Science and Technological Development of the Republic of Serbia (Grant No. 175014).

### REFERENCES

among academic youth in Poland. Expert Rev Pharmacoecon Outcomes Res. (2016) 16:199–205. doi: 10.1586/14737167.2016. 1154790

**Conflict of Interest:** The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Copyright © 2019 Luketina-Sunjka, Rancic, Mihailovic and Jakovljevic. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

# Employee Acceptance of Use: A Precondition for Enhancing Therapy Effectiveness, Patient Safety, and Economic Efficiency

Maximilian C. von Eiff 1 , Wilfried von Eiff 2 \*, Andreas Roth3 and Mohamed Ghanem3,4

*1 St. Josef Hospital Hamm (Franziskus Stiftung Muenster), Hamm, Germany, 2 Center for Hospital Management, University of Muenster and Center for Health Care Management and Regulation, HHL Leipzig Graduate School of Management, Leipzig, Germany, 3 Department of Orthopedics, Traumatology and Plastic Surgery, University Clinic of Leipzig, Leipzig, Germany, 4 HHL Leipzig Graduate School of Management, Leipzig, Germany*

Introduction: From the workplace engineering sciences, it is evident that work efficiency, measured by the criteria efficiency and effectiveness of therapy, economy and patient safety, is determined mainly by staff acceptance of new technology and reengineered workflows. Accordingly, the aim of this study was to ascertain and assess differences in terms of the acceptance of alternative types of prosthesis instrument configurations, oriented around the research question: "Which product features and process effects determine a high level of employee acceptance of use?"

#### Edited by:

*Michael E. Otim, University of Sharjah, United Arab Emirates*

#### Reviewed by:

*Guenka Ivanova Petrova, Medical University, Sofia, Bulgaria Julie Abimanyi-Ochom, Deakin University, Australia*

> \*Correspondence: *Wilfried von Eiff<EMAIL_ADDRESS>
#### Specialty section:

*This article was submitted to Health Economics, a section of the journal Frontiers in Public Health*

Received: *16 July 2019* Accepted: *06 November 2019* Published: *05 December 2019*

#### Citation:

*von Eiff MC, von Eiff W, Roth A and Ghanem M (2019) Employee Acceptance of Use: A Precondition for Enhancing Therapy Effectiveness, Patient Safety, and Economic Efficiency. Front. Public Health 7:353. doi: 10.3389/fpubh.2019.00353* Materials and Methods: This study is designed as a before-and-after comparison, based on the usability engineering approach. In the first study phase, 46 employees participating in the process of providing instruments for a total knee arthroplasty (TKA) procedure were asked to examine the current working situation, using a standard instrumentation set, in terms of instrument handling, work burden, proneness to errors, patient risks, process efficiency, and effectiveness. In the second study phase, 20 weeks after having implemented a size-specific instrumentation set, the same 46 individuals were surveyed on the identical questions. Additionally, in both study phases the time needed to perform the sub-processes related to instrumentation logistics inside the operating room (OR) was measured, in order to identify process efficiency and cost-saving effects.

Results: By using standard sets only 30% perceived a need for improvement. After 20 weeks, only 8% of the employees were satisfied with the previous equipment and 69% regarded the standard set as being relatively error-prone, endangering patient safety. In addition, 85% regarded the effectiveness of the standard process as limited. Finally, 75% considered the effectiveness of the reengineered process to be significantly higher, and 69% drew attention to the reduction of handling disadvantages. Furthermore, the time needed for instrumentation logistics inside the OR estimated at about 13 min less when using size-specific sets. This effect on process efficiency cost savings or the generation of additional revenue by performing additional procedures. Based on these findings, an ergonomic decision-making model has been developed.

**58**

Conclusion: Innovative medical products such as size-specific instrumentation sets contribute to lower procedure costs and improved process efficiency in the operating room (OR). However, employee motivation to use a new technology as part of an optimized workflow organization, is crucial to achieving an enhanced level of effectiveness, efficiency and patient safety. Hence, it is advisable to enhance change-management efforts in order to reduce resistance to change and ensure the new technology is successful.

Keywords: change management, innovative technology, ergonomic model, patient safety, opportunity costs, theater workflow efficiency

#### INTRODUCTION

Innovative technologies, in combination with the optimization of clinical processes [e.g., introduction of surgical robots for radical prostatectomies; size-specific instrumentation sets in total knee arthroplasty (1–3)], is generally stated as the most effective way of gaining cost savings in hospitals (4) and simultaneously ensuring workplace effectiveness. We know from economic analysis and industrial ergonomic research (5) that there is a direct cause and effect correlation between a fatigue-proof work system design and productivity and quality. The same effects have also been demonstrated in various empirical studies in the field of behavioral work research [also refer to the "Hawthorne Effect" (6, 7)], as well as individual motivation theories [such as the "Dual Factor Theory" by Herzberg (8)].

Hospital research into the correlation between the design of the working environment and workplace equipment, on the one hand, and working effectiveness as well as patient risks, on the other hand, demonstrates that impairments due to stress factors from poor workplace equipment and related issues, have an adverse effect on the well-being of employees in clinical areas and lead to mistakes at work. This is the research focus of the "Healing Environment Approach" (9, 10). Empirical findingsinto the correlation between well-being in the workplace, on the one hand, and working efficiency and possible errors, on the other hand, are of particular importance. Distractions, which disturb ones' concentration exert a negative impact on working effectiveness and on the risk of employee errors. In this regard, various studies have examined a direct cause and effect correlation between the comfort of wearing OR (operating room) clothing and working efficiency, or the potential for errors to be made by OR personnel. For example the "Karmasin Study" (11) is based on the working hypothesis, that the comfort of surgical gowns (expressed by the quantifiable criterion "body temperature"), can influence the performance of surgeons to the extent that poor breathing of textile materials can trigger heat stress during longer surgical procedures (lasting more than 2 h), which can have an adverse impact on psychomotor characteristics (12).

A second aspect of acceptance research refers to the fact that innovative technologies are associated with changes in workflow organization and disruptions in interworking patterns. Many employees fear fulfilling the requirements of the new work environment and assume there is a risk of being burdened by additional tasks and responsibilities.

Acceptance of a new technology and the associated reorganization measures is more likely, particularly if the people affected by and those involved in a reorganization can be persuaded that:

Examples of the types of "improvements" which are typically requested by employees and which encourage acceptance are (13–16):

Despite these employee requirements with respect to bringing medical products with handling advantages into the working process, many hospitals prefer a price-driven procurement policy due to increasing financial pressure. Accordingly, for purchasing officers in hospitals, the price of a product is the dominant criterion when selecting and buying a medical product. Handling advantages, procedure time reduction and patient safety aspects play only a minor role in the purchasing criteria catalog. This restrictive purchasing philosophy in many hospitals is a major hurdle to bringing innovative products into practice (17).

### GOAL

The overall aim of the study was to determine the importance of employee acceptance-to-work on process efficiency in the OR, tested by a planned organizational change of instrumentation sets. It was thus intended to ascertain and assess differences in terms of the acceptance of alternative types of prosthesisinstrument configurations (standard vs. size-specific instrument trays) used in total knee arthroplasty (TKA). The guiding research question was: "Which product features and process effects caused by the instrument configuration determine a high level of acceptance of use?" Furthermore, the following research hypothesis was tested and confirmed: "Employee acceptance of standard instrumentation sets is significantly lower than that of size-specific sets."

Major objectives were to determine whether innovative medical products contribute to reducing procedure time in the OR, as well as leading to cost savings, and to determine whether handling complexity caused by medical products influences the acceptance-to-work of employees.

The study was conducted in two phases, whereby specific objectives were set for each phase.

The aim of the first study phase was to examine how satisfied employees are with the existing technical equipment, based on standard instrument sets used in a total knee arthroplasty procedure. The purpose of this first acceptance study was to establish whether and to what extent employees feel that there is a need to change the instrumentation-management process. The subsequent analysis of the organizational workflow of the instrument logistics aimed to:

The aim of the second study phase was to identify differences in the acceptance behavior of employees involved in the process of instrumentation management as surgeon, scrub nurse or technician in the central sterilization department (CSSD).

#### MATERIALS AND METHODS

This investigation is designed as a "structural study," a type oriented to the "Social System Approach" by Luhmann (20) and typically used in Human Relations Research represented for example by Sanders and Kianty (21). A structural study aims to identify the patterns, dynamics and stability of an organizational system (22–24) which is described by the design elements "task," "person," "device," "information," "space," "time," "relations" (25) and "institutions" (26). The term "institutions" refers to official rules, regulations, agreements and unwritten rules (27). Institutions are the driving factors of a socio-technical system. The productivity of a socio-technical system such as a hospital is measured by the variance in the output of this system (28).

Especially in the field of Industrial Ergonomics the "Usability Engineering Approach" of Backhaus (29), as well as the "Analytic Job Evaluation" via workload-stress-concept of Rohmert (30) are used for observational workplace research with the number of participants limited between 5 and 20. Furthermore, in lean management theory, especially in the area of patient safety through product design, standardization and work-cell design (31, 32), the generic structure of a process helps identify cause-and-effect relations as well as typical pitfalls in the process. The essence of the study is a "usability test" of an innovative size-specific instrumentation set configuration (sizespecific set). Usability tests as carried out in the present study are observational studies of work systems and workflows and are quite different to the study types normally used in clinical or epidemiological studies (cohort, case control, prevalence studies). These study types are common for testing innovative procedures (e.g., TAVI: Transapical Aortic Valve Implantation) or new drugs (e.g., Multiple Sclerosis treatment regime based on Rituximab) and require more participants (n > 500) for ensuring statistical validity and reliability. For usability tests a minimum cohort of 5–20 procedures is recommended (33–35).

This study was conducted in a university hospital, commencing in March 2017 with the study design and the documentation of results and findings was completed in September 2018. All data related to this study excluded patientspecific data. The staff council, as the legal representative of employees in Germany (participants), consented to support the study. According to both German and European regulations, performing and publishing this study does not require ethical approval (36). Furthermore, surgical departments in Europe are free to decide which surgical instruments they use for performing a procedure, provided these instruments have been approved by a notified body (37). In this study, only instruments such approved and certified with a CE mark (Conformité Européenne) and/or conformity assessment were employed. Finally, the medical products utilized all fulfill the requirements of German (38) and European Union Law (39).

The current acceptance analysis entails a before-and-after comparison between standard sets and size-specific instrument sets. Several implants and types of sets are available on the market. In our study as well as in our practice, we use a "tibia-first" system for performing a Total Knee Arthroplasty (TKA) procedure. We start by preparing the tibial plateau and adjust further operative technical steps accordingly. Further, we performed non-navigated TKA. In all cases, the patella was not everted, the posterior cruciate ligament was retained and the collateral ligaments remained intact.

Size-specific trays only contain size-related instruments e.g., cutting guides and trial implants. These instruments are only suitable for a defined implant size, so that the surgeon has to anticipate the size of the relevant components prior to starting the procedure, based on preoperative planning. The final decision is made intraoperatively, according to the local findings and intraoperative measurement. The size of a tibial component can be measured by referring to the size of the tibial plateau after superficial bony resection. The femoral component is measured prior to bony resection. The size of the inlay always corresponds to the size of the femoral component. The thickness (height) of the inlay is measured by referring to the extension- and flexiongap and must ensure stability as well as a sufficient range of motion. From the logistical point of view, the availability on call of different sterile trays containing possible sizes must be ensured in order to prevent any outcome risks to the patient.

In the survey, the employees involved in the sub-processes of "instrument preparation" and "cleaning up the OR," as well as the staff responsible for cleaning and reprocessing the sets and the surgeons performing the TKA procedure, were asked via questionnaire and interviewed on the following criteria:

After having delivered the completed questionnaire, all employees participating in the study were interviewed one-onone about the reasons underlying their evaluation of the current instrumentation setting.

The survey was conducted among 46 employees (8 surgeons, 20 scrub nurses, 18 CSSD technicians) in two study phases. The first study phase (starting situation with standard set configuration) aimed at determining to what extent from the viewpoint of employees, a change in the instrumentation organization is necessary. In the second study phase carried out 20 weeks after having implemented the size-specific set type, a second acceptance analysis was accomplished in order to determine changes in employee acceptance, especially referring to "process effectiveness" and "susceptibility to error."

In order to identify differences in process efficiency between the various instrument settings the time needed for performing the two sub-processes "preparation of all instruments" and "clearing up of used and unused instruments" was measured. "Duration" of a sub-process related to instrumentation logistics can validly be used as a proxy for process efficiency and cost savings. A reduced OR occupation time possibly allows performing an additional procedure, which yields additional revenue and contributes to avoiding higher payed overtime for the OR staff in the afternoon of a working day in the theater. Accordingly, 14 TKA procedures with standard sets and 18 TKA performed with a size-specific set were observed and the durations of the sub-processes relevant for instrumentation management were measured. Only procedures were observed in which the 46 selected employees were involved. By using this approach, confounding effects due to different learning curves and skill bases of employees, could largely be eliminated. All comparison figures and measures used are composed on **Table 1**.

## RESULTS

The results are segmented into five areas of appraisal criteria.

(1) Employee satisfaction with current situation

Nearly every third employee (31%) was dissatisfied with the original situation (standard instrument system) and expressed a need for change (see **Figure 1**). The initially high proportion (∼70%) of employees who were satisfied (more precisely: "not dissatisfied") is attributable, among other things, to two phenomena:

This is illustrated by the assessment of process effectiveness (see **Figure 2**), which is interpreted as the "contribution made by the organization of the process (including the use of technology) to shorter instrument cycle times, reduced risk of errors and lower costs."

According to that, only about 8% of the employees were really satisfied with the standard system. They were particularly critical of:

Furthermore, the employees addressed the fact that there is a direct cause and effect relationship between the "quantity of instruments," on the one hand, and "time pressure during the process workflow" and the "effectiveness of quality control," on the other hand.

(2) Process effectiveness

This is defined here as the contribution of the process organization to shorter turn-around-times, reduced workflow risks for staff and patient, and top lower costs.

The employees rated the effectiveness of the standard system as "effective to a limited extent" (69.2%) or "minimally effective" (15.4%). This assessment is shared by scrub nurses and CSSD personnel alike, as well as by surgeons, albeit for other reasons. The surgeons are critical of the lack of clarity as to what is in the trays, the CSSD personnel bemoan the weight of the trays, time pressure and complexity of the process, and the scrub nurses complain about a shortage of space to accommodate the trays in the OR.

(3) Proneness to error

The proneness of the standard system to errors, due to its complexity, is also regarded as significantly high at almost 70% (see **Figure 3**).

(4) Complexity of handling and clarity of arrangement of instruments on trays

TABLE 1 | Figures, definitions, and measures used to run the comparison between two medical products and the two types of process these products characterize.

#### Definitions of key figures and measures

#### Efficiency and effectiveness of a product (here: prosthesis and instrumentation system) are measured by selected and well-defined figures

All of the occupational groups involved feel that the overall working system would benefit greatly if there were a significant reduction in the number of trays and of instruments (see **Figure 4**). These advantages relate primarily to more convenient handling, greater clarity, less time pressure and a lighter workload, less error-proneness

as a result of simple instructions, as well as more effective quality control.

At this point, an important cause-and-effect relation emerges: complexity and handling comfortability are experienced in terms of the weight and number of trays, which have to be used in the theater. Furthermore, the number of instruments arranged on a tray is a complexity indicator. Another complexity measure is the percentage of instruments transported back to the CSSD for reprocessing, without having been used during the TKA procedure. The before-after comparison demonstrates the use of

TABLE 2 | The proportion of instruments placed on a tray, but not used during the procedure is a proxy indicator for work complexity and cost.

The complexity of a prosthesis and instrumentation system is an important cost driver as well as a hidden source of failures within the scope of the instrument cycle

standard instrumentation systems seems to be accompanied by a higher degree of complexity (see **Table 2**).

As a result of the first study phase, it is evident that the personnel is generally in favor of a reduction in the number of trays and instruments.

Some 20 weeks after the introduction of the size-specific system, a second acceptance study was conducted in order to gauge how satisfied the personnel were with the new instrument logistics solution. The before-and-after comparison reveals a marked rise in perceived process effectiveness, i.e., in the contribution of the process organization toward shorter turnaround times, reduced risks and lower costs (see **Figure 5**).

Obviously, there is a very tight cause-and-effect relationship between the acceptance of an instrumentation setting and the quantity of instruments and number of trays used. Acceptance of a care variant with OR trays is essentially determined by the number of trays and the number of instruments placed in the trays. The number of instruments, which are not used, but are reprocessed, has a particularly negative effect.

There was also a clear improvement in satisfaction in terms of being "error-prone" (see **Figure 6**). For instance, 69% of those questioned regarded the standard system in the original situation as error-prone, whereas the size-specific organization was only classed as error-prone by 25%.

(5) Process efficiency

In this context process efficiency is defined as the relation between an input of resources e.g., personnel, medical products as well as devices, and the result gained by combining these resources in a well-organized medical procedure. Process efficiency is measured by the duration of uniquely defined sub-processes, the number of instruments used in relation to the number of instruments placed on a tray when starting the procedure and the direct costs as well as the opportunity costs caused by a procedure.

Opportunity costs are understood as a benefit, gain or value of something that must be given up to acquire or achieve something

else (40, 41). Typical opportunity costs appear when for example an OR is blocked due to an extended procedure time as a consequence of non-availability of medical products needed for the procedure, or when a bed is occupied because a patient acquired a nosocomial infection.

In addition to these findings, using size-specific instrument sets contributes significantly to shortening the duration of the sub-processes for "preparing instrumentation equipment before starting operation" (incision time) and "cleaning up of used and unused instruments" after the surgeon has finished the procedure (suture time). "Process time" can be used as a proxy for process efficiency, because the time saved can be used alternatively for performing an additional procedure that yields additional revenue or for avoiding expensive overtime hours for the staff in the afternoon of a working day in the OR. In order to obtain evidence on this issue, a generic process model was constructed, which depicted the sub-processes performed in the context of a TKA procedure (see **Figure 7**).

The total process for the instrument handling was reduced from 28:45 to 15:08 min, which corresponds to a time gain and reduction of the occupancy time of the OR of 13:22 min (53%) for one TKA operated (see **Table 3**).

On premise that 4 TKA are performed over one working period per day, the theater is occupied for 08:35:00 h. A time reduction of 13:22 min per TKA procedure leads to a reduced occupancy time of the OR by 53:28 min on average. This time saved can be used to perform an additional procedure, e.g., an Arthroscopy (including biopsy). The procedure time is usually 30 min, so that two efficiency effects can be identified:

The total theater occupation time is reduced from 08:35 to 08:30 h.

TABLE 3 | Comparison of the durations of sub-processes related to instrumentation logistics.

#### Process efficiency

The duration of the sub-processes related to instrumentation logistics is significantly (53%) shorter when using size-specific instrument sets, a remarkable contribution to process efficiency and cost reduction.

#### TABLE 4 | Results according to selected criteria.

The table of results (see **Table 4**) summarizes the major findings of the study and indicates the superiority of size-specific instrument trays. Moreover, it is evident that the sustainable success of innovative medical technologies in practice e.g., new products, re-organized workflows or disruptive procedures, depends on the acceptance-to-work of the employees working in the re-organized process. And this acceptance is heavily influenced by the impact of the innovative technology on procedure handling, costs, workflow efficiency, and patient safety. All these aspects are a direct result of the nature of design of an innovative technology.

### DISCUSSION

This comparative analysis demonstrates a significant improvement in process effectiveness in terms of shortened turn-around times, reduced risks and lower costs. Also, the susceptibility to error caused by the complexity of the standard instrumentation set was originally rated significantly higher (70%).

This study also demonstrates that a lower number of instruments arranged on a tray contributes to a more stressfree and ergonomic work environment, to more effective quality control and a reduction in time pressure.

Another important finding concerns the change management organization, which is crucial for the economic success of a new implemented technology or workflow.

Moreover, it should be noted that the quality of changemanagement (key user support, help desk, training, tryout opportunities) contributes to shortening the learning phase and raising acceptance.

Furthermore, it is evident that the percentage of employees who class an instrument system as "error-prone" after a switchover is all the higher, the shorter the period of time between the system switchover and the acceptance study. The reason for this is that a short timeframe does not permit learning-curve effects so that personnel remain rather unsure about how to use the new and unfamiliar system.

Referring to the previously mentioned price-driven procurement philosophy, which guides many hospitals, and bearing all findings of this study in mind, it is highly advisable to change the procurement policy for purchasing medical products and devices used during surgical procedures from a price-driven management approach to a value-based philosophy.

The value of a medical procedure is defined as the relation between patient outcome, patient safety, procedure time, patient

pain level and patient length of stay on the one hand, and procedure costs on the other hand. Accordingly, the most important assessment criteria (45) for selecting the right medical product within the frame of a procurement decision-making process are "usability" (ease of use, avoidance of patient risks, low workload), learning-curve effects and reduced process time (see **Figure 8**).

From all these preliminary considerations, an ergonomic decision-making model (46) can be derived (see **Figure 9**) which establishes a relationship between

#### CONCLUSION

The design, ergonomics and functionality of innovative medical products have a tremendous impact via the ease of handling, on costs, therapy effective-ness, work environmental and patient safety.

Given that ease of handling directly influences employee acceptance of a re-engineered process or an innovative medical product or disruptive technology, this can be regarded as a crucial precondition for the efficiency and effectiveness of workflows.

### LIMITATIONS OF THIS STUDY

One limitation of the analysis is that clear recommendations pertaining successful change- management strategies and effective change management tools cannot be derived so far

#### REFERENCES

in this context. Further research and practical tests of selected organization-development interventions are needed.

A second limitation is that learning-curve effects could not identified and measured, due to a lack of robust criteria. Thus, the "time saved" in the sub-process of instrumentation logistics was used as a proxy for deriving information about process efficiency.

Thirdly, the analysis of opportunity costs is based on the premise that the department is working at full capacity. Yet, due to a lack of qualified staff in the German health care system, the number of hospitals working at only 70–75% capacity utilization is rising.

Furthermore, additional research aiming to identify differences in patient outcome in changing technology settings, should be intensified.

### DATA AVAILABILITY STATEMENT

The datasets generated are not available for third parties due to data security requirements of staff-related data. Requests to access the datasets should be directed to WE<EMAIL_ADDRESS>
### AUTHOR CONTRIBUTIONS

ME, WE, and MG developed the study design. ME designed the questionnaires, prepared the data analysis, wrote the first draft of the manuscript, integrated proposed revisions, and performed the manuscript revision. AR, WE, and MG wrote sections of the manuscript. AR and MG supported the data collection and obtained the permission of the work counsel. All authors read and approved the submitted version.

### ACKNOWLEDGMENTS

The authors thank Dr. Brian Bloch (University of Muenster, Germany) for his comprehensive editing of the revised version.

erweiterte Auflage. 2nd ed. Stuttgart: Kohlhammer Verlag (2016). p. 478–88.

**Conflict of Interest:** The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Copyright © 2019 von Eiff, von Eiff, Roth and Ghanem. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

# Trends in Shared Decision-Making Studies From 2009 to 2018: A Bibliometric Analysis

Cuncun Lu1,2, Xiuxia Li 1,2 and Kehu Yang1,2 \*

*1 Evidence-Based Medicine Center, School of Basic Medical Sciences, Lanzhou University, Lanzhou, China, 2 Evidence-Based Social Science Center, School of Public Health, Lanzhou University, Lanzhou, China*

Background: To systematically analyze the global development trends and research focuses of shared decision-making (SDM) studies as a reference for researchers.

Methods: We conducted a systematic search of the Web of Science (WoS) Core Collection on April 17, 2019, to retrieve studies related to SDM published from 2009 to 2018. VOSviewer (1.6.10), CiteSpace (5.4.R1) and Excel 2016 were used to analyze key features of SDM studies, including annual output, countries/regions, organizations, journals, authors, references, research hot-spots, and frontiers.

Results: Up to April 17, 2019, a total of 6,629 studies on SDM were identified as published between 2009 and 2018. The United States participated in the most studies (*n* = 3,118), with the University of California-San Francisco ranking first (*n* = 183). *Patient Education and Counseling* [impact factor (IF) 2017 = 2.785] published the most studies (*n* = 257). Legare F participated in the most studies (*n* = 101), and the paper "Charles C, 1997, Soc Sci Med, V44, P681" occupied the highest co-citation (*n* = 657) position. The research hotspots and frontiers included "Informed consent," "Surgery," "Depression," "Older adult," and "Patient-centered care."

Conclusion: The number of studies concerning SDM has continued to increase since 2009, with the United States leading the field. The landscape of the basis of SDM included mainly concept, practice framework and effect assessment of SDM. "Informed consent," "Surgery," "Depression," "Older adult," and "Patient-centered care" reflected the latest research focuses, and should receive more attention.

#### Keywords: shared decision-making, VOSviewer, CiteSpace, surgery, bibliometric analysis

## INTRODUCTION

Evidence-based medicine revolves around the concept that all decision-making regarding health should be based on best clinical evidence available, while emphasizing clinician experience and patient preferences and values (1, 2). When there are several alternatives, the patient's choice may determine the final treatment plan (3). Shared decision-making (SDM) is a new practical model applied to the field of healthcare that refers to clinicians working together with patients to make all decisions related to their health, including prevention, diagnosis, and treatment of conditions based on available evidence (4, 5). Several studies have showed SDM's advantages; for example, a Cochrane review (6) of more than 100 trials showed that SDM led to better outcomes in the decision-making and post-decision processes, as well as the intervention effect. In addition to

#### Edited by:

*Sandra C. Buttigieg, University of Malta, Malta*

#### Reviewed by:

*Afolaranmi Olumide Tolulope, Jos University Teaching Hospital, Nigeria Ranjeet Kumar Sinha, Patna Medical College, India*

\*Correspondence: *Kehu Yang<EMAIL_ADDRESS>
#### Specialty section:

*This article was submitted to Public Health Policy, a section of the journal Frontiers in Public Health*

Received: *20 August 2019* Accepted: *29 November 2019* Published: *18 December 2019*

#### Citation:

*Lu C, Li X and Yang K (2019) Trends in Shared Decision-Making Studies From 2009 to 2018: A Bibliometric Analysis. Front. Public Health 7:384. doi: 10.3389/fpubh.2019.00384*

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improving clinical outcomes, SDM can reduce medical costs (7). Therefore, close cooperation between clinicians and patients in the development of treatment options is highly beneficial (8).

Bibliometric analysis is a scientific method that combines statistical methods with information visualization technology to identify core entities, development trends and research focuses of specific subjects or research domains. A variety of software is available that can be used for bibliometric analysis, such as VOSviewer (9) and CiteSpace (10, 11). Recently, this method has been widely employed to conduct scientometric reviews (9, 10). For example, Qiu et al. (9) employed VOSviewer to review the evolutionary process of osteoporosis in post-menopausal women. This analysis showed a gradual shift in the research focus to precision medicine-orientated "basic research." Using CiteSpace to analyze the development trends and research frontiers in the field of Alzheimer's disease, Liu et al. (10) identified biomarkers and diagnostic criteria as the main focuses of Alzheimer's disease research.

In an analysis of publication trends of the top 15 high impact medical journals from 1996 to 2011 conducted in 2014, Blanc et al. (12) showed an exponential increase in SDM-related publications. However, this study had a number of limitations. First, the study focused on a relatively small number of high impact medical journals; therefore, important papers published in general journals may have been overlooked. Second, this study focused mainly on scientific outputs, which may limit the implications for researchers. Third, although this study was published in 2014, the analysis focused only on the period from 1996 to 2011, and so did not include any more recent findings that may have been available. Therefore, we employed the VOSviewer and CiteSpace to conduct a new bibliometric study of SDM articles and reviews indexed in the Web of Science (WoS) Core Collection as a dataset to map the global trends and research focuses in the field of SDM.

### MATERIALS AND METHODS

#### Data Sources

We conducted a comprehensive search of the WoS database on April 17, 2019, at Lanzhou University, Lanzhou, Gansu, China. To identify the recent developments, the timespan was set from January 1, 2009 to December 31, 2018. To ensure the representativeness of included studies, the types of publications were limited to "article" and "review." The search strategy was as follows: Topic = "shared decision making" OR "informed decision making" OR "shared medical decision making" OR "informed medical decision making." To avoid bias, all hits were downloaded as txt-format files from WoS on April 17, 2019 for further analysis.

#### Statistical Analyses

The WoS and VOSviewer (1.6.10) (9) were used to analyze key features (annual output, countries/regions, organizations, journals, impact factor (IF), authors, and references) of the SDMrelated studies retrieved on April 17, 2019. VOSviewer was used to construct a network map of countries/regions, organizations,

authors, and references, respectively. CiteSpace (5.4.R1) (10, 11) was used to construct dual-map overlay of journals and explore keywords with strong burst strength. Excel (Microsoft 2016, WA, USA) was used to manage data, create other charts and all data tables. The VOSviewer settings were as follows: counting method (full counting), while, thresholds (T) of items (countries/regions, organizations, authors, and references) were adopted based on special situations. The parameters of CiteSpace were as follows: link retaining factor (LRF = 2), look back years (LBY = −1), e for top N (e = 2), time span (2009–2018), years per slice (1), links (strength: cosine, scope: within slices), selection criteria (Top 50).

### RESULTS

#### Annual Output

In total, we retrieved 6,629 SDM-related studies published from 2009 to 2018; therefore, the average annual output was 662.9. In the 2009, only 229 studies were published; however, 10 years later in 2018, the annual output reached 1,199. As shown in **Figure 1**, the annual output related to SDM research showed an obvious upward trend during the period from 2009 to 2018.

#### Analysis of Countries and Organizations

The top 10 countries and organizations participating in SDM studies are presented in **Table 1**.

As shown in **Figure 2A**, each country participated in at least 144 studies related to SDM. Moreover, six (United States, England, Canada, Netherlands, Australia, and Germany) of these countries participated in at least 506 studies. Furthermore, close cooperation was observed between of these countries. Among them, the United States participated in the most studies (n = 3,118), followed by England (n = 742), Canada (n = 694), and Netherlands (n = 574).

As shown in **Figure 2B**, every organization participated in at least 118 studies related to SDM, with four (University of California-San Francisco, Mayo Clinic, University of Sydney and University of Washington) participated in at least 143 studies. Furthermore, close cooperation was observed between several organizations, such as the University of Ottawa and the University of Laval, McMaster University and the University of Toronto, Radboud University Nijmegen and Cardiff University, and the University of California-San Francisco and Mayo Clinic. Among them, the University of California-San Francisco ranked first, participating in 183 studies, followed by Mayo Clinic (n = 176) and the University of Sydney (n = 158).

### Analysis of Journals

The top 10 journals publishing SDM studies are presented in **Table 2**. These 10 journals totally published a combined total of 915 studies related to SDM, representing ∼14% of all 6,629 studies retrieved. Three journals (Patient Education and Counseling, Health Expectations and PLoS ONE) published at least 90 studies each (257, 115, and 90, respectively). In terms of IF, all 10 journals were ranked from 1.733 (Patient Preference and Adherence) to 4.345 (Implementation Science), with an average IF value of 2.721. **Figure 3** shows the four citation paths. The two green paths indicate, articles published in medicine/medical/clinical journals cited journals mainly in the fields of molecular/biology/genetics and health/nursing/medicine. The other two pale blue paths indicate, articles published in psychology/education/health journals cited journals mainly in the fields of health/nursing/medicine and psychology/education/social.

### Analysis of Authors and References

The top 10 authors and co-cited references of SDM studies are presented in **Table 3**. As shown in **Figure 4A**, every author participated in at least 26 studies related to SDM; with three (Legare F, Elwyn G and Stacey D) who participated in at least 59 studies. Furthermore, close cooperation was observed between several authors, such as Legare F and Stacey D, Labrecque M and Legare F, Montori VM and Leblanc A, and Elwyn G, and

TABLE 1 | The top 10 countries and organizations participating in shared decision-making studies.

TABLE 2 | The top 10 journals publishing shared decision-making studies.

*† IF, Impact Factor.*

FIGURE 2 | The distribution of countries (A, *T* = 51) and organizations (B, *T* = 94) participating in decision-making studies (The size of node represents the number of studies, and the thickness of line represents the degree of cooperation).

TABLE 3 | The top 10 authors and co-cited references of shared decision-making studies.

Edwards A. Among them, Legare F ranked first in terms of the number of studies contributed (n = 101), followed by Elwyn G (n = 84) and Stacey D (n = 59). In terms of co-cited references, each reference was cited at least 192 times, with five ["Charles C, 1997, Soc Sci Med, V44, P681" (13), "Charles C, 1999, Soc Sci Med, v49, P651" (14), "Elwyn G, 2012, J Gen Intern Med, V27, P1361" (4), "Barry MJ, 2012, New Engl J Med, V366, P780" (15), "Makoul G, 2006, Patient Educ Couns, V60, P301" (16)] being cited at least 312 times. Furthermore, several references, such as "Charles C, 1997, Soc Sci Med, V44, P681" (13), "Charles C, 1999, Soc Sci Med, v49, P651" (14), and "Makoul G, 2006, Patient Educ Couns, V60, P301" (16), were cited by other articles simultaneously (**Figure 4B**).

### Analysis of Keywords

The top 20 keywords with strong burst strength in SDM studies are presented in **Table 4**. The keywords with strong burst strength could represent research hotspots and frontiers (11). Using CiteSpace to explore keywords with strong burst strength, we found that these keywords covered many aspects of SDM, including "older adult" and "children;" "depression" and "schizophrenia;" "informed consent," "surgery," "patient participation" and "patient-centered care," and "scale," "framework" and "qualitative research." In terms of burst strength, "Informed consent," "Recommendation," "Surgery," "Patient participation" and "Depression" had higher (N > 15) burst strength. In terms of end-year, the five keywords comprised "Clinical practice" (2014–2018), "Surgery" (2015– 2018), "Recommendation" (2016–2018), "Decision-making" (2016–2018), "Implementation" (2016–2018), and all were published in 2018 (**Figure 5**).

## DISCUSSION

### General Information

In this study, we conducted a bibliometric analysis to identify the core entities and map global trends and research focuses of SDM studies to provide a reference for researchers in this field.

We found a rapidly increasing trend in SDM studies published between 2009 and 2018, which is consistent with the findings of Blanc et al. (12) Among the top 10 countries/regions, the United States (n = 3,118) participated in by far the most papers and had an absolute advantage in terms of the number of studies,

FIGURE 4 | The distribution of authors (A, *T* = 22) and co-cited references (B, *T* = 152) of shared decision-making studies (The size of node represents the number of studies or co-cited number, and the thickness of line represents the degree of cooperation or co-cited strength).

TABLE 4 | The top 20 keywords with strong burst strength in shared decision-making studies.

followed by several other countries from Western countries, such as England (n = 742) and Canada (n = 694). Meanwhile, there was also close cooperation between these countries. The possible reasons for this result are, their medical concepts and technology are often in the leading position in the world, and they have a profound knowledge accumulation. Among the top 10 organizations, the University of California-San Francisco (n = 183) and Mayo Clinic (n = 176) participated in the most papers, ranking first and second, respectively. Furthermore, among the top 10 organizations, two (University of Toronto, McMaster University) were from Canada, one (University of Sydney) was from Australia, and all the rest were located in the United States. There was also a high degree of cooperation between the organizations, such as McMaster University and the University of Toronto, and the University of California-San Francisco and Mayo Clinic. In relation to the top 10 journals, Patient Education and Counseling (n = 257, IF2017 = 2.785) and Health Expectations (n = 115, IF2017 = 2.173) published the most papers, ranking first and second. Implementation Science (n = 63, IF2017 = 4.345) had the highest IF, while the IFs of Patient Education and Counseling and Health Expectations ranked in only a medium position. Moreover, most of the journals focused on public health or medicine, and usually cited papers from the fields of health or social science. Among the top 10 authors, Legare F (n = 101), Elwyn G (n = 84), and Stacey D (n = 59) ranked first, second, and third, respectively, and we found close cooperation between Legare F and Stacey D. Moreover, Legare F and Elwyn G were authors of the most co-cited documents (4, 17, 19). These results can provide guidance for beginners in this field to cooperate with other entities, and submit their manuscripts.

#### Intellectual Base

A document co-citation network represents how frequently two studies are cited together by other papers (10, 11). These co-cited studies could be regarded as intellectual base of a special field or subject, which is also known as knowledge base (10, 11). Thus, we focused on the top 10 co-cited studies to evaluate the intellectual base related to SDM.

The most cited study with the highest number of co-citations (n = 657) was published in 1997 by Charles et al. (13). This study provided a clearer definition of SDM by identifying the following four key features: (1) two objects (clinician and patient) must be involved; (2) they should share information that they have; (3) they should reach a consensus based on treatment preference; and (4) reaching consensus on the treatment to practice. The second most cited paper received 334 co-citations, and also was published by Charles et al. (14), this paper revisited their framework on SDM, and raised decision-making approaches between three predominant models of SDM. The third most cited paper was published in 2012 by Elwyn et al. (4), with 319 co-citations. This paper proposed a specific three-step model of practice SDM, involving introduction of choice, description

of alternatives, and helping patients to explore their preference and aid in their decision-making. The fourth most cited study, with 312 co-citations, was published in 2012 by Barry et al. (15). These authors proposed that SDM as the central tenet of patient-centered care was long overdue, and recommended that clinicians should view the healthcare experience through their

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Lu et al. Trends in SDM Studies