Abstract
The formally reported number of adverse events may be open to ambivalent interpretation – actual higher prevalence of adverse events versus a patient safety culture supporting reporting and learning. Many methods appearing in the literature that are not based on reporting systems struggle for adequately assess the precise level of prevalence of adverse events. Confronting this challenge in patient safety research, we suggest evaluating the perceived state of “almost no adverse events” in the ward, by using a short Likert- type scale we developed for this purpose. Some evidence for its reliability and validity are presented using two samples (99 head nurses, and 383 nurses). As was expected, leadership had a significant direct effect on the measured state of “almost no adverse events” as well as an indirect effect mediated successively by psychological safety, and safety behavior.
Keywords
Background
Improving patient safety, meaning the prevention of errors and adverse effects to patients associated with the provision of healthcare, is imperative in healthcare organizations (Kohn, Corrigan, & Donaldson, 2000; Makary & Daniel, 2016). Patient safety is ultimately reflected by the actual prevalence of adverse events, defined as injuries related to medical management in contrast to disease complications (Brennan et al., 1991). Much research has focused on the factors influencing the prevalence of adverse events. Nevertheless, we assert that the straightforward approach of using formally reported adverse events might be open to ambivalent interpretation.
Reporting adverse events is a major mean of learning about and improving patient safety (Vogus, Sutcliffe, & Weick, 2010). To continuously improve the system, adverse events must be analyzed, their root causes determined (to understand how ‘latent errors’ play a role in a chain of events that sets up the occurrence of an ‘active error’), and actions taken to implement the needed changes (Leape, 2002). Cumulative empirical findings, however, reveal that the reporting levels are still low (Mitchell et al., 2016; Wachter, 2010).
Several causes may explain the persistent gap between the actual and the reported prevalence of adverse events (Leape, 2002). These may be grouped into two main categories that rationalize why the prospective benefits of reporting an adverse event outweigh its price:
“It isn’t beneficial” – First, low levels of trust in management’s commitment to leading a change, and timely engagement in rectifying the underlying system shortcomings indicated by the reported incidents, make the time, and effort involved in reporting seem unjustified. Considering the heavy workloads typical of many healthcare settings, investing time in reporting that does not seem to lead to actual improvement in patient safety is a serious disincentive (e.g., Frankel, Leonard, & Denham, 2006; Mahajan, 2010; Ramírez et al., 2018).
“It isn’t safe” – The second obstacle is low psychological safety, meaning the belief that one is able to express oneself without fear of negative consequences (Liang, Farh, & Farh, 2012). Psychological safety might be especially low in healthcare cultures that emphasize professional accountability and lean on the assumption that “one must not be wrong” (e.g., Conchie, Taylor, & Donald, 2012; Mariner & Miller, 2001).
Thus, reporting an adverse event may be perceived not only as futile but also as risky and harmful.
Consequently, as has been previously recognized, the number of formally reported adverse events may have two contrary interpretations. On the one hand, lower reporting levels may indicate higher patient safety; yet, on the other hand, they may indicate low levels of psychological safety, learning, and patient safety (Vogus, Sutcliffe, & Weick, 2010).
This ambiguity calls for assessing the actual prevalence of adverse events by looking beyond the formally reported numbers. Prior research used various means to achieve this. Some studies
Other studies used the staff’s perception of the prevalence of adverse events. Team members used a Likert-type scale ranging from “never” to “frequently” to report their assessments regarding specific types of adverse events such as falls (Boamah, Laschinger, Wong et al., 2018). This less labor-intensive method, however, still suffers the disadvantage of excluding less common types of adverse events.
To meet, at least partially, the challenge of gauging the state of patient safety, meaning the degree to which the unit is approaching the goal of “almost no adverse events”, we developed a short Likert-type scale assessing the staff perception of their ward in terms of this ideal state.
Method
As a first step, we built, as recommended (Norman, 2010), a symmetric, seven-point scale, with a clear middle point: 1–very strongly disagree; 2–strongly disagree; 3–disagree; 4–neutral, 5–agree; 6–strongly agree, 7–very strongly agree.
As seen in Table 1, we wanted the scale to be comprehensive, to include all types of events, not only specific predetermined ones. It was also intended, by asking respondents to compare their ward to similar ones, to take into account features of the ward that are relevant to the prevalence of adverse events such as type, size and intensity of activity.
Frequencies, means, and standard deviations for nurses’ demographic characteristics for the two sample.
To test the scale’s reliability and validity, we, first, presented the items to a group comprising five head nurses and twenty nurses from different healthcare organizations. They confirmed the scale’s face validity.
The scale was thereafter administered to a sample of 99 head nurses (see Table 1), and an exploratory factor analysis (extraction method: principal component analysis) was conducted.
The results indicated that, as was expected, all the items were loaded on a single factor (see Table 2).
Principal component analysis of the scale items with two samples.
We then tested for construct validity with a sample of 383 nurses from a variety of healthcare organizations and wards (see Table 1).
Based on previous research, we expected that the construct measured by the scale, meaning the level to which the ward reaches the optimal state of “almost no adverse events”, would positively correlate with three variables. The first variable was nurse safety behavior, which includes safety compliance, as well as proactive safety behaviors such as engaging in quality improvement, and speaking up. We assessed this variable with Neal and Griffin’s six-item safety behavior scale (2006), and the ten-item voice scale by Liang, Farh, and Farh (2012). This scale’s Cronbach’s alpha was 0.96 (see Table 3).
Research variable means, standard deviations, inter-correlations, and scale reliabilities- Nurses sample (N = 383).
*Correlation is significant at the 0.05 level (2-tailed); **Correlation is significant at the 0.01 level (2-tailed).
The second variable was the head nurse’s leadership. We assessed this variable with Paglis and Green’s eight-item scale (2002). This scale’s Cronbach’s alpha was 0.95 (see Table 3).
The third variable was the nurse’s psychological safety. We assessed this variable with Liang, Farh, and Farh’s three-item scale (2012). Cronbach’s alpha for this scale was 0.82 (see Table 3).
We also expected that there would be a negative correlation between the construct measured by the scale and the estimated number of adverse events in the last six months as estimated by the nurse. Due to memory gaps and variance in the wards’ type, size, and workloads affecting the ability of the respondents to adequately note the exact number of adverse events, we expected that this correlation would be moderate.
Further, based on previous research, we also expected nurses’ safety behavior will mediate the effects of psychological safety (e.g. Liang, Farh, and Farh’s, 2012), and leadership style (e.g. Boamah, Laschinger, Wong et al., 2018; McFadden, Stock, & Gowen, 2015) on patient safety. Further, since leadership influences psychological safety (e.g. Walumbwa, & Schaubroeck, 2009), we anticipated finding that psychological safety mediates some of the effect of leadership on patient safety behavior and the resulting construct measured by the scale.
Results
As seen in Table 3, Cronbach’s alpha reliability of the scale was 0.89.
First, as was expected, and seen in Table 3, there were rather high positive significant correlations between the construct measured by the scale and the three predictors, patients safety behavior (r = 0.62, p < 0.01), psychological safety (r = 0.54, p < 0.01), and leadership (r = 0.62, p < 0.01). Further, as was expected, there was a significant moderate negative correlation between the construct measured by the scale, and the number of adverse events in the last six months as estimated by the nurse (r = –.219, p < 0.01).
Second, we conducted two mediation analyses using SPSS’s PROCESDS software package, following Hayes’ recommended three steps (2017). As expected, the results (see Table 4) of the first step showed that both predictors, nurse’s psychological safety (b = 0.21, [0.13 0.30]), and head nurse’s leadership (b = 0.63, [0.55 0.72]), made a significant positive contribution to the construct measured by the scale.
Mediation analyses – Indirect effects of psychological safety and leadership on the measured construct (“almost no adverse events”) mediated by safety behavior.
The second step showed that safety behavior significantly (b = 0.31, [0.17 0.44]) predicted this construct beyond the contribution of psychological safety and change initiating leadership.
The third step revealed that there were significant indirect effects of leadership (ab = 0.07, [0.02 0.12]), and psychological safety (ab = 0.07, [0.02 0.12]) on the construct via safety behavior. Last, as expected, there was also a significant direct effect (B = 0.34, [0.20, 0.49]) of leadership but not of psychological safety on the construct beyond their contribution via safety behavior.
Further, we conducted an analysis using SPSS PROCESS (Model 6) looking for the indirect effect of leadership on the construct mediated successively by psychological safety and safety behavior. As expected, this indirect effect was significant (ab = 0.05, [0.02, 0.09]).
Conclusions
It is important to be aware of the possibly ambiguous implication for the level of patient safety of formally reported adverse event occurrences. The results of our analyses imply that our proposed scale is adequate for use in future research seeking to establish the “bottom line” of patient safety, meaning the degree to which the ward is achieving the goal of “almost no adverse events”. The results indicate its reliability and provide initial support for its construct validity. Beyond the expected correlations of the construct measured by the scale with psychological safety, leadership, and safety behavior, the pattern of the direct and indirect effects are in congruence with previous research (Boamah, Laschinger, Wong et al., 2018; Liang, Farh, and Farh’s, 2012; Walumbwa, & Schaubroeck, 2009). These results show that leadership is an important determinant of psychological safety, which in its turn contributes to safety behaviors as voice. Further, leadership also contributed directly to safety behavior, and to the measured construct, while psychological safety had no direct effect on this construct. Yet, future research may add support to the scale construct validity by using data from different sources.
Previous measurement of safety culture relies on staff perception i.e. the Safety Attitudes Questionnaire (Sexston et al., 2006), and the AHRQ HSOPS (Sorra, & Dyer, 2010). These large- scale multi- dimensional measurements incorporate items about perceived safety. Relying on the front line providers' perception regarding the state of reaching “no adverse event” by their work unit cansimilarly contribute to patient safety research by providing a relatively efficient method for assessing the perceived pervasiveness of adverse events in the unit .
Footnotes
Declaration of conflicting interests
The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Funding
The author(s) received no financial support for the research, authorship, and/or publication of this article.
