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. 2025 Apr 24;20(4):e0322215. doi: 10.1371/journal.pone.0322215

Psychological safety and patient safety: A systematic and narrative review

Anthony Montgomery 1,*, Vilma Chalili 2, Olga Lainidi 3, Christos Mouratidis 4, Ilias Maliousis 5, Konstantina Paitaridou 4, Alison Leary 6
Editor: Wen Wu7
PMCID: PMC12021220  PMID: 40273220

Abstract

Objectives

Various psychological concepts have been proposed over time as potential solutions to improving patient safety and quality of care. Psychological safety has been identified as a crucial mechanism of learning and development, and one that can facilitate optimal patient safety in healthcare. We investigated the quantitative evidence on the relationship between psychological safety and objective patient safety outcomes.

Methods

We searched 8 databases and conducted manual scoping to identify peer reviewed quantitative studies published up to February 2024. Objective patient safety outcomes of any type were eligible. The findings were analysed descriptively and discussed in a narrative synthesis.

Results

Nine papers were selected for inclusion which reported on heterogeneous patient safety outcomes. Five studies showed a significant relationship between psychological safety and patient safety outcomes (e.g., ventilator associated events, reported medical errors). The majority of studies reported on the experiences of nurses working in healthcare from the USA. Patient safety is consistently characterised as the absence of harm rather than a culture that creates a safe environment.

Conclusions

No clear conclusions can be extracted regarding the relationship between psychological safety and patient safety. For example, reporting patient safety problems in a team can be an indication of both high and low psychological safety. Patient safety may be contradictory to elements of psychological safety, as the absence of harm is not congruent with a safety environment approach. Systematic review registration: This systematic review is registered with the International Prospective Register of Systematic Reviews (PROSPERO CRD4202347829).

Introduction

Psychological safety (PS), which describes a work environment where people believe that candor is expected and possible, is particularly important for patient safety. PS has matured as a core concept in management and psychology, as the number and reach of studies have grown exponentially [12]. While PS has been linked to lower job burnout levels [3] and a supportive work context [4], Edmondson and colleagues [2] pinpoint the limitations, which include a significant lack of knowledge about creating PS and the role other team members play in this, measurement in non-Western countries, and lack of longitudinal research. In healthcare, a recent research synthesis found that substantial variations in PS were reported by healthcare workers across all studies, and evidence that there is an ongoing need to focus upon its improvement [5]. Moreover, there is evidence that PS doesn’t work in the expected way in healthcare [68], where figuring out what can be talked about (and not talked about) trumps the generic idea of PS per se. This results in a paradoxical phenomenon, whereby high PS teams appear to operate less safely due to their increased tendency to report more unsafe practices and the willingness to report incidents [9,10]; such facts raise questions about the role and function of PS within medical practice suggesting that it represents an organizational culture element rather than a straightforward determinant of patient safety culture. PS may seem to operate differently within healthcare, stressing the reconstruction of error management culture, where errors are viewed as ongoing learning and improvement in safety practices, fostering collective accountability, and mutual trust rather than the straightforward equation of the absence of reported errors with increased patient safety indicators. This perspective may challenge conventional organizational norms that equate fewer errors and mistakes with success [11]. To better understand why this is happening it is necessary to evaluate the existing evidence on the relationship between PS and patient safety outcomes, providing a deeper analysis that can delineate what elements of PS are linked with patient safety.

Psychological safety and patient safety

The relevance of PS to medical and clinical settings lies in its facilitation of intuitive processes/reasoning [12] such as fostering open team communication, trust, interpersonal evaluations, and goal-directed behaviour (e.g., intention to benefit patients and avoid harm) that can enhance social team interactions by removing barriers of reprisal and fear [13]. Traditionally, PS has been linked to positive outcomes that include learning [1415], creativity and proactivity [16], innovation [17], improved practice [18] and adaptation to changes [19]. Despite these more positive outcomes, there is emerging evidence that ‘too much’ PS has negative consequences [6,20], meaning that it is hard to know what psychological safety is NOT. For example, Eldor et al [6] in their research on professional actions among nurses found that when tasks are routine, high levels of PS climate can harm in-role performance potentially due to cognitive distraction or task experimentation. Interestingly, Jung et al [21] while exploring the relationship of PS and objective professional actions (e.g., the use of an incident and near-miss reporting system) from various professional groups involved in delivering care for radiation oncology found an ever more complex outcome. PS did not correspond to the use of the reporting system as professions with lower PS were more likely to use the reporting system compared to physicians who expressed the highest PS. A critical consideration regarding the challenges of in-role performance and identity on the commitment to learning from incidents and errors arises from this perspective. It can be also assumed that when systems fail to provide meaningful feedback or translate incident reports into actionable improvements, PS “loses” undermining its role in promoting a culture of continuous improvement and reciprocal communication. As a result, when talking about PS, more attention may have been given to healthcare professionals’ willingness to report errors and, thus neglect its impact on actual objective actions of reporting – while both subjective intentions and objective actions balance medical accountability [22]. In fact, it is well-established across decades of research on the links between intentions and behaviours that self-reported intentions do not always align with objective observable actions in clinical settings. However, as intentions are usually measured in a vacuum with generic questions (e.g., not linked to specific context), it should not be surprising that such theoretical predictions do not hold in practice. For example, while an increased amount of literature has subjectively measured reasons why healthcare workers do not speak up, so far interventions attempting to increase voice based on that evidence are not succeeding [23]. Within healthcare, safety culture highlights the importance of how subjective perceptions and beliefs could positively influence attitudes and objective actions related to safety [24,25]. However, considering the criterion of hospital safety – despite the well-meaning intentions – a plethora of error reporting rates may obscure critical safety signals in the health industry [26]. This emphasis on quantity (fewer errors reported) over quality (leveraging reported errors for ongoing learning, targeted analysis, and improvement) [27] conflicts with the core principles of PS within hospital safety frameworks. Defining the commitment to advancing safe care, patient safety—the most enduring and foundational principle of medicine—represents the core value of healthcare quality by emphasizing freedom from any harm associated with health care in clinical practices [28]. “An organisation with a memory” established the perspective beyond individual accountability recognising that errors in medication administration concerns an even more intricate and complex causation [29]. The field of patient safety has been informed by the area of safety compliance, which refers to following safety protocols meant to protect both employees and patients. Following protocols is associated with fewer occupational injuries [3031], however PS might mean that justifiable deviance is warranted, as recommended by the Safety II approach [32]. Medical errors translate into over three million deaths globally each year [33] and are a key contributor to provider depression, posttraumatic stress disorder, suicidality, impaired work performance, burnout, and turnover [34]. Sources of medical errors include the actions of health care professionals, safe care system failures (e.g., communication failures), or a combination of errors made by individuals, system failures, and patient characteristics [35].

PS, with its focus on high-quality communication, trust and decision-making is assumed to play an important role within workplace teams generally, and particularly in healthcare, with the notion that when healthcare teams are psychologically safe, they are more likely to engage in quality improvement and team learning initiatives [3637]. Moreover, effective working relationships have been tied to improved quality of patient care in a variety of clinical settings [3840]. According to the upward voice communication framework, in psychologically safe work environments, employees—regardless of their identity role (e.g., nurse, physician), seniority, or frontline status, whether first-line staff, middle management, or executives — shouldn’t hesitate to report safety concerns regardless of power differentials as speaking up should be seen as a contribution to safety rather than wrongdoing or personal failure [41]. However, regardless of the upward communication framework, a historical stigma is attached to error reporting in healthcare, as in highly complicated environments, this could lead to personal accountability [42]. The essential problem is that increasing PS in a team can lead to negative and opposite effects on positive risk-taking behaviours via fear of failure and decreased work motivation [43]. Therefore, the direction or existence of causality between patient safety and PS is not clear.

Study objectives

This systematic narrative review aims to summarize and clarify the existing evidence concerning PS and patient safety outcomes in healthcare to uncover the conceptual, theoretical and methodological challenges in linking the two. The review included only studies that used robust measures of patient safety outcomes linked to observable professional actions or/and reporting behaviours as opposed to self-report ratings of perceived patient safety, given the evidence that self-reports can artificially inflate the relationship between safety climate and safety outcomes [44].

The following research question was considered: What evidence supports the relationship between PS and actual patient safety outcomes? There is a bigger question to consider as to what extent increased reports of patient safety incidents and unsafe practices indicate a culture of transparency and learning rather than a true decline in safety performance. The review aimed to gain insights for interventions and policy in health and social care, aligning the concepts of learning and clinical performance to foster innovation in error management towards a high-quality multiperspective approach to safety culture.

Methods

The high heterogeneity of outcomes did not allow for meta-analytic synthesis; thus, a narrative approach was deemed most appropriate.

Search strategy

This review was developed following the PRISMA guidelines [45] and the accompanying PRISMA Checklist is available in S1 File.

This systematic review included only studies with robust quantitative indicators as they employ systematic and epidemiological methods to quantify specific aspects of objective patient safety measures, including the use of the reporting system and checklists, adverse events, harm to patients and providers, and risks associated with adverse events [46]. Time and country restrictions were not applied. The electronic databases consulted with language restrictions to English were PubMed, PsycINFO, Scopus, Embase, Cochrane Library, Web of Science, CINAHL and the search was supplemented by Google Scholar and manual scoping (S2 File). The review searched databases up until February 2024.

Eligibility criteria and study selection.

The exclusion/inclusion criteria are available in S3 File. Duplicate control and title and abstract review were conducted using Rayyan. Two authors independently first screened for inclusion by title & abstract (n = 573) and then conducted a full-text review (PRISMA flow diagram Fig 1, reasons for exclusion see S4 File). Cohen’s kappa indicated substantial inter-rater agreement for title & abstract screening (k = 0.95, 98.2%). Regular meetings with a third reviewer allowed discussion of article eligibility resulting in a total of eighty-nine articles for full-text screening. Low agreement (k = 0.36, 79%) was found for the full- text review due to the vastly heterogeneous outcomes related to patient safety measures (e.g., perceived level of patient safety versus metrics of patient-safety outcomes). A third reviewer reviewed all the 89 articles independently and a fourth reviewer examined conflicting decisions. Addressing the above-mentioned conflicts resulted in the final inclusion of nine articles for review [4755].

Fig 1. Prisma flow diagram.

Fig 1

Quality assessment and data extraction.

Two authors independently extracted all the collected data (see S5 File for extracted data) and conducted quality assessments for included studies using the Quality Assessment Tool for Observational Cohort and Cross-Sectional Studies [56]. Quality assessment was also independently reviewed by other two authors (k = 0.81, 90.5% almost perfect agreement;). Eight studies were rated as Fair (score > 7 < 11) and one as Good (for details per study see S6 File).

Results

Descriptive information on the studies

The total sample of participants was N = 17,926. Gender representation was noted in only 44% (4 out of 9) of the studies. Of the total sample, 88.4% were nurses. Detailed information on study characteristics is available in Table 1. Almost all included studies (8/9) were conducted in the USA and most were published between 2017–2023. Six of the studies used Edmondson’s PS questionnaires. Two studies used items from the Workgroup psychological safety questionnaire of the Veterans Health Administration’s “All Employee Survey”. One study used items from the Learning Organization Survey (LOS). The following patient safety outcomes were limited to objectively observable professional actions and reporting behaviours (i.e., reporting of medical errors, treatment errors, medication errors, incidents, near misses, occupational injuries, following protocol/checklist, the use of seclusion and physical restraining).

Table 1. Study Characteristics (n = 9).

Authors (Alphabetical) Country Participants (Total N, % Women) Design Measure of Psychological Safety Patient Safety Outcome Study Qualityb
Anderson et al. (2021) United States Mental health
(n = 797)
Registered Nurses
(n = 4331)
Licensed Practical Nurses
(n = 1518)
6646, NR Cross-sectional
Retrospective Database Analysis
Workgroup psychological safety
from the “All Employee Survey” within the Veterans Health Administration
The use of seclusion and physical restraining in inpatient psychiatric units. 9/14
Arnetz et al. (2019) United States Nurses in the hospital 432/95.1%
83 blood samples; 95.1%
Cross-sectional
Retrospective Analysis
Edmondson (1999) (1) pressure ulcers (2) patient falls
(3) central line-associated blood stream infections (CLABSI)
(4) catheter-associated urinary tract infections (CAUTI)
(5) ventilator-associated events (VAE) - All unit level
7/14
Brimhall et al. (2023) United States All employees of a non-profit hospital from various departments 318 employees from 47 workgroups; NR Cross-sectional Edmondson (1999) Reported medical errors 8/14
Gilmartin et al. (2018) United States Nurses working in a Veterans Health Administration hospital 2008
1,962; 78.19%
2009
1,926; 77.21%
2010
2,428; 76.89%
2011 1,973; 75.98%
Cohort Study - Retrospective Database Analysis One item from “All Employee Survey” Nonadherence rates to the central line checklist:
(1) hand hygiene
before central line insertion
(2) application of
chlorhexidine gluconate (prep)
(3) use of a cap
(4) mask,
(5) sterile gloves,
(6) sterile gown by the provider inserting the central line
(7) full-body drape to cover the patient
7/14
Halbesleben et al. (2013) United States Registered Nurses 658, 87% Cross-lagged study Edmondson’s (1999) adapted version (Nembhard & Edmondson, 2006) Occupational Injuries 9/14
Jung et al. (2021) United States Staff of a Radiation Oncology Department 78, NR Cross-sectional Learning Organization Survey (LOS) Willingness to report incidents (near misses and therapeutic incidents) 9/14
Leroy et al. (2012) Belgium Nurses and Head nurses from various specialty departments nurses = 580; 75%
head nurses = 54; 56%
Cross-lagged Safety For Nurses: Simons et al. (2007).
PS For Teams: Edmondson (1999)
Reported Treatment Errors that resulted in harm to a patient. 9/14
Raman & Green, (2017) United States Non-physician healthcare professionals 803, NR Cross-sectional Edmondson (1999) Medication administration processes in healthcare settings/ records 9/14
Ridley et al. (2020) United States Operating Rooms (ORs) Clinicians 73 at Baseline 6-month Follow-Up: 68
12-month Follow-Up: 68
NR
Cohort Study Edmondson (1999) Medical Errors Reported During Surgical Cases (defined as a preventable adverse event resulted OR NOT in harm to a patient) 11/14

a Data Extraction for included articles.

b Quality assessment is performed with the use of the Quality Assessment Tool for Observational Cohort and Cross-Sectional Studies (Feng et al., 2014). The tool contains 14 criteria, and the evaluator is asked to answer whether the study in question meets the criterion. The possible answers are Yes, No, Cannot determine, Not applicable, and Not reported. A score of > 11 corresponds to good quality, 7–10 to fair quality and < 7 to poor quality.The breakdown of individual scores can be found in S5 File.

*NR=Not Reported

Is there a relationship between psychological safety and patient safety?.

PS and positive objective patient safety outcomes are sometimes “difficult” to detect and resistant to linear interpretation, as PS seems to share contextual dependencies between objective reporting behaviour and patient safety. Additionally, high reporting rates may indicate high PS, where incidents are openly discussed and used as learning opportunities and protocol compliance. Conversely, low reporting rates might be interpreted as evidence of enhanced team performance, although this could also reflect underreporting or fear of disclosure. Of the nine studies, only five studies indicated a significant relationship between PS and patient safety [5052,54,55]. However, all five studies need further qualification to fully appreciate the complexity in linking PS and patient safety. The influence of PS on patient safety varies significantly depending on the specific outcomes measured, the context in which safety incidents/error occur, and the kind of incidents/error. Anderson et al, [51] in a sample of inpatient psychiatry clinicians, found that units with lower PS reported a greater use of restraints with patients, but also found that units with higher PS utilized seclusion more. This outcome is complex and somewhat paradoxical, as seclusion is considered a last-resort strategy to ensure safety [5758]. According to the results of the study feelings of PS—or the lack thereof—influence healthcare providers’ direct behaviour and, consequently, the kind of care (seclusion vs physical restraints) provided to patients.

Halbesleben et al,[50] in a sample of nurses, found that leader behavioural integrity and the reporting of medical errors was related when PS was high. These findings suggest that the degree to which employees feel psychologically safe directly impacts their willingness and ability to comply with safety protocols. Anderson et al, [51] and Halbesleben et al, [50] findings may indicate behavioural dynamics underlying PS and patient safety complex trade-offs. Brimhall et al, [55] in a sample of 318 healthcare employees, found a negative association between PS and reported medical errors, suggesting that high-PS teams may have open dialogue among team members about errors to learn from mistakes and improve systems to reduce future errors. Also, the idea that high-PS doesn’t lead to progress in the short term was reflected in Leroy et al, [52] who also found that PS had a negative relationship with the number of reported treatment errors, with the authors speculating that this relationship could be reversed in the long run. PS alone might increase the reporting of errors, which initially has an opposite effect on the safety records. However, when cultivating both a strong adherence to safety protocols (priority of safety) and a supportive error management where staff feel secure in voicing concerns and reporting errors (PS) it could point to a safety culture where errors are not just reported but also decreases over time.

Jung et al, [54] in a sample of radiation oncology department staff, presented five scenarios about a patient with a cardiac pacemaker (arranged in order of proximity to failure) and showed that PS is an important predictor of reporting incidents and selected near-miss types. However, the effect of PS on reporting near-miss events became stronger only with the events’ increasing proximity to a negative outcome. These results reflect the question of how safety protocols are placed regarding reporting incidents such as “actual harm” and “almost happened”, as it is indicated that PS appears to operate differently depending on the kind/type of incident. Overall, the evidence linking psychological and patient safety is equivocal.

In the remaining four studies, Arnetz et al, [47] in a sample of nurses, found that Unit-level PS was not significantly associated with Central Line-associated bloodstream infections, Catheter-associated urinary tract infections or Ventilator-associated events. Ridley et al, [48] examining a teamwork training program among cardiothoracic operating room members, found that while there was a trend towards lower error rates, the rates of positive PS measured at the group level did not change significantly during their study. Gilmartin et al, [49] in a sample of nurses, found no statistically significant differences in PS scores for units with 5% or less checklist nonadherence and units with more than 5% checklist nonadherence within any year of the data. Raman & Green, [53] in a sample of non-physician clinician workforce across 27 patient-care units, the relationship between employees’ perceived PS and their proportion of timely medication use was non-significant.

Methodology and sampling issues.

The majority of studies used the Edmondson questionnaire to assess PS (7/9). The use of a common metric is desirable and provides the opportunity for comparison. The Edmondson questionnaire prompts individuals to report on what is permissible in their team/workgroup. However, this begs the question as to what team do individuals have in mind when they fill in these questionnaires. We don’t know and this may explain the ambiguous relationship between PS and patient safety. As noted by Edmondson & Bransby [2], the literature on PS thus far provides relatively little insight on how interpersonal climates change over time and on how or when to intervene productively. Other unaccounted for factors may also influence the way that PS is understood by different members of the team. For example, Grailey et al, [5] in an evidence synthesis of PS in healthcare, concluded that many of the factors that contribute to PS are not malleable or easy to change (especially within a resource poor environment). Thus, knowing why PS is low may be as important as knowing if it is low. Meta-analytic evidence indicates that internal consistency can be low for PS measures (i.e., alpha <.70 or <.79) [59]. This may reflect the fact that not all elements of PS are necessarily present in the same team/organization or not all elements are experienced and perceived the same by all team members/employees, with implications for whether treating PS as a latent variables is wise or approrpaite

The representativeness of the nine studies reviewed was limited. The majority of the studies (8/9) were conducted in the US and reported on the experiences of nurses and women. Thus, even for the five studies that reported an association, our ability to generalise is extremely restricted, and review findings might be more representative of the research and experiences of nursing professionals and of women working in healthcare. To achieve a better understanding of the complex phenomena of PS and patient safety in healthcare, future research needs to address all involved professional groups. Additionally, the US centric character of the reviewed papers means that it not only suffers from the so-called “WEIRD” problem—meaning that the majority of research is usually carried out in western and developed countries – but we also can’t be sure whether the findings are generalizable outside the US.

Direction, timing and causality.

The review highlighted some contradictions about the timing and mechanisms of PS. Certain papers suggested that higher levels of PS should be associated with more error reporting (i.e., Leroy et al [52]), while others suggested the opposite (i.e., Anderson et al, [51]). The former was linked to the notion that increased feelings of PS should lead to more reporting, whereas the latter is linked to the idea that less error occurrence will be a consequence of a more “healthy” team/unit environment. The crucial issue is the development of PS over time – whether it’s at the beginning of the process or well established within the team. For example, in the study of Ridely et al [48] the rates of positive PS measured at the group level did not change significantly during their study, but satisfaction with teamwork and feeling comfortable to speak up measured on a daily basis did show improvement over the period of the training. Thus, PS appears to work differently comparing group and daily measures. Moreover, while the number of medical errors decreased, error reporting did not significantly increase, leading the authors to speculate that individuals no longer felt that it was helpful to report minor errors to the hospital system due to better communication between employees. It’s not clear what the causal mechanism linking feelings of safety and reporting is. The study of Anderson et al, [51] with inpatient psychiatry clinicians, found that units with lower PS made more use of physical restraint among patients, but those with higher PS reported greater use of seclusion strategies. Significantly, PS is considered a cognitive concept [60] thereby linked to emotional states that in healthcare providers could lead to biases in decision-making, impacting patient care practices related to safety and quality [61]. The authors attempted to explain these contradictory findings by reflecting on whether seclusion use is viewed as relatively noncoercive or a less coercive way of managing violent/disruptive behaviour. Thus, it could be the “lesser of two evils”. In the Leroy et al, [52] study of nurses, the authors suggest that higher levels of PS could result in the reverse results over time (i.e., less reported errors) because an environment supportive of reporting errors can help employees learn from mistakes in the long run. Jung et al, [54] in their scenario study, speculate that improving PS may not increase recognition of near misses, particularly those that more closely resemble standard care than an incident. The influence of PS on reporting is more pronounced in scenarios where near misses are perceived as more critical or dangerous.

In the Arnetz et al, [47] study, PS was associated with self-reported stress and competence development but not significantly with biological markers or objective patient outcomes. The Gilmartin et al, [49] study concludes that their data neither supported their hypothesis or previous research findings concerning the link between PS and error reporting. The reflection by the authors on the results is revealing of the confusion surrounding PS. Potential reasons for the lack of association include the presence of the observer producing an improvement in performance (i.e., Hawthorne Effect), reporting on nonadherence being perceived as risky and a fear that they may be personally blamed for not taking ownership which resulted in many nurse respondents selecting the neutral response, “neither satisfied nor dissatisfied” on the PS question. Overall, the discussion sections of the reviewed papers provided interesting speculations regarding the relationship between PS and patient safety. However, it’s not a healthy sign for the field that diverse speculations are so numerous.

Discussion

Overall, there is relatively little hard data to link PS and patient safety outcomes. Only nine studies fit the criteria that examined PS and objective measures of patient safety. This is stark contrast to literature that purports a clear link between the two phenomena [5,62,63]. The findings of the review imply a contradiction in patient safety practices: enhancing team dynamics through PS culture may improve immediate problem-solving within the team, but it does not automatically translate into improved objective patient safety measures.

Potential reasons for the lack of evidence

The simplest and initial point to accept is that we simply don’t have enough research yet to establish a link between PS and objective measures of patient safety. Absence of evidence is not evidence of absence. However, that caveat should not prevent us from discussing the potential factors influencing the relationship. For example, a line manager may espouse the importance of safety procedures while they fail to enact, enforce, and support the same safety procedures through their actions via monitoring and allocation of time and resources. As a result, employees may experience a double bind between these seemingly conflicting behaviours [64] (p. 117): “…when employees adhere to a norm that says, “hide errors,” they know they are violating another norm that says, “reveal errors””The employees are thus in a double bind.

As noted by Halbesleben et al, [63] looking at only one indicator (e.g., frequency) may not represent the whole picture of safety, whereby a low frequency of injuries may actually be an indication of low reporting rather than an indication that the organization scores high on safety. Congruently, severe injuries are usually more heavily controlled by protocols, meaning ‘less serious’ problems are less likely to be reported. Thus, we may need to examine which type of patient safety outcomes link with PS. Additionally, the timing of the patient safety events is critical. As noted by Hirak et al, [65] near misses that occur early in the process of care may be perceived as cognitively distal to the averted failure, thus underscoring resilience. In contrast, near misses that occur later in the process may be perceived as cognitively proximate to the averted failure, thus underscoring vulnerability. This distinction between what represents resilience and vulnerability is especially pertinent in the healthcare industry where risk is a constant concern. However, the definitions of patient safety in the literature reviewed, largely focus on the prevention of harm rather than creating a safety culture in which PS is an integral part.As noted by Reason, safety is more than the absence of harm [66].

Limitations concerning the present review centre around the fact that patient safety metrics and medical accountability represent concrete phenomena, while PS is an abstract psychological phenomenon. However as stated above, this narrow view of safety as absence of harm could be broadened. The current literature focuses on what can be measured in terms of healthcare performance (harm) and not what is perceived (safety). What can be measured then becomes the focus, and increasingly a performance target. When a measure becomes a target, it ceases to be a good measure and the change in focus may account for the discrepancy in findings [67]. Limitations on definitions and operationalizations also concern patient safety, given that patient safety outcomes are not universal and even basic definitions differ across countries – especially terms like “medical errors”, which concurrently function as legal terms [68]. According to Kaldjian et al, [69] even in teaching hospitals, a gap exists between the intention to report and the actual act of reporting medical errors, due to severe repercussions; thus, there might be scope for PS to be more important in predicting the expected/possible errors rather than the reported/occurred ones. Some common reasons that may lead to underreporting behaviour include fear of legal complications, fear of peer judgement/disapproval, negative attitudes toward reporting errors, lack of time, and the complex process of reporting [7073]. Nurses are often the most frequent reporters of incidents, compared to physicians [74], which means a more heterogeneous sample may produce different outcomes.

Conclusions

Ultimately, we are left with a paradox regarding PS in healthcare teams. Reporting patient safety problems in a team can be both an indication of high and low levels of PS. It’s difficult to know which without understanding the culture and history of the specific healthcare organization, as PS primarily impacts emotions and attitudes rather than patient safety metrics directly. The most reliable evidence concerning the benefits of PS relate to creative/learning activities, however it can be detrimental concerning routine tasks. The way that PS is assessed needs further exploration, as it’s not yet clear what individuals have in mind when reporting on the climate in their team for sharing information. Psychological and patient safety may not be easily aligned. The paradox between PS and patient safety lies in their contrasting definitions and goals. Patient safety aims to prevent harm in clinical settings, but this view may be too narrow to assert a relationship with PS in healthcare organisations. In contrast, PS promotes a culture of interpersonal risk-taking within teams. This inherent conflict arises because risk-taking, fundamental to PS, contradicts the principles of patient safety grounded in established medical protocols.

Supporting information

S1 File. PRISMA checklist.

(DOCX)

pone.0322215.s001.docx (32.1KB, docx)
S2 File. Search strings.

(DOCX)

pone.0322215.s002.docx (24.5KB, docx)
S3 File. Inclusion-exclusion criteria.

(DOCX)

pone.0322215.s003.docx (14.3KB, docx)
S4 File. Reasons for exclusion.

(PDF)

pone.0322215.s004.pdf (171.1KB, pdf)
S5 File. Extracted data.

(PDF)

pone.0322215.s005.pdf (241.7KB, pdf)
S6 File. Quality assessment.

(PDF)

pone.0322215.s006.pdf (88.9KB, pdf)

Acknowledgments

No acknowledgements.

Data Availability

All relevant data are within the manuscript and its Supporting Information files.

Funding Statement

The author(s) received no specific funding for this work.;

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Decision Letter 0

Anna Rachel Conolly

18 Dec 2024

PONE-D-24-42345Psychological safety and patient safety: a systematic and narrative reviewPLOS ONE

Dear Dr. Montgomery,

Thank you for submitting your manuscript to PLOS ONE. After careful consideration, we feel that it has merit but does not fully meet PLOS ONE’s publication criteria as it currently stands. Therefore, we invite you to submit a revised version of the manuscript that addresses the points raised during the review process.

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Additional Editor Comments:

Dear Authors,

Three thorough reviews of your work have be returned. I find reviewer the third reviewer's comments to be particularly helpful - i.e. reframe the research question in a manner which recognises the complexity of the link between high psych safety and the appearance of a greater number of patient safety incidents and unsafe practices. This could then be unpicked in great detail in the results section. I look forward to reading the revised paper.

[Note: HTML markup is below. Please do not edit.]

Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. Is the manuscript technically sound, and do the data support the conclusions?

The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented.

Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #3: Yes

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2. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #1: N/A

Reviewer #2: N/A

Reviewer #3: N/A

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3. Have the authors made all data underlying the findings in their manuscript fully available?

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified.

Reviewer #1: No

Reviewer #2: Yes

Reviewer #3: Yes

**********

4. Is the manuscript presented in an intelligible fashion and written in standard English?

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Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #3: Yes

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5. Review Comments to the Author

Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #1: Introduction:

- Major: The problem analysis does not fit the research question. Bade on the introduction, the reader expects the paper to focus on the complex relationship between PS and outcomes and especially the underlying mechanisms. In stead the paper focuses on the evidence of the relationship and its implications for interventions. Following the introduction, the research question should be wider and especially include the subjective patient safety outcomes in order to unravel this complex relationship. OR the introduction should be complete rewritten in order to focus on why we need a summary of evidence for this specific relationship, why is it so important to show the reader this overview of evidence. In addition, also argue why this overview does not include the subjective safety outcomes.

- Minor: Why is there a heading called “psychological safety and psychological safety”

Methods:

- In the future you might consider using tools to assist you in a systematic review, such as Ryyan or ASreview

- You might consider identifying other reviews on PS. What did and didn't they conclude. Did they also include your selection of papers. Have you identified new papers or was this review also be able to be conducted based on the present reviews?

Results:

- In the interpretation of the relationship there is a lack of nuanced. If a relationship between PS and medical errors is found, this means that people are more or less willing to report errors, it is not the same as the actual errors made. One could argue both ways: high PS could make the reporting of errors less urging and therefore lower OR high PS could make the reporting of errors more natural in an open and learning environment. This is somewhat later on discussed but not incorporated in the presentation of the results at the beginning of the Result section.

- There is a lack of insights presented in teamwork in healthcare. People that filled in the questionnaire of Edmondons are healthcare professionals. They are part of multiple teams; multi teammembership. What are the teams we are referring to in the result section. Are that the multidisciplinairy teams that provide care? Or the monodisciplinairy teams? That is a big difference in relation to PS. In multidisciplinairy teams the different disciplines are stables but not the people representing this discipline.

Discussion/conclusion:

- What is the answer to the second part of the research question?

- Not clear what this review adds. The paradoxes where already know prior to the research. Make clear what we did not know and after the review do know.

- After rewriting the introduction, have in mind that the introduction and discussion should cover other angles. Now they are too similar in their message.

Reviewer #2: This is a really interesting and important paper and congratulations to the authors. The comments made here are in the spirit of strengthening the paper.

The definition of psychological safety is important. Edmondson’s 1999 definition and measurement is not just about me being able to take risks (express vulnerability) in relation to what I do and do not know but also relates to me being able to question my colleagues on their actions and how correct/safe they are. E.g. it is an important point made in the introduction that in healthcare a lot of time is spent trying to figure out what is safe to talk about – but is this not what psychological safety is about?

There are more nuanced definitions of patient safety other than freedom from harm and as you argue this is not a good definition. I think these other definitions informed by Safety Management Systems work in aviation and other fields should also be included here?

Section – Psychological safety and should be ‘patient’ safety?

Line 80 - Medical errors third leading cause of death – needs to be nuanced

https://qualitysafety.bmj.com/content/26/5/423

Lines 85-90 Should psychological safety not also lead to increased reporting of adverse events and to increased challenges to each other on unsafe practices?

Methods

Search strategy

Line 112 – why were only quantitative studies included – needs justification

Results

Line 138 not sure why female participants pulled out in particular – would it be more appropriate to say ‘Only 4 out of 9 studies noted gender of participants’.

Line 142 needs more discussion on what tools other than Edmondson were used.

Discussion

Line 279 – or improved objective patient safety measures (rather than just formal reporting or errors?) and what are these?

Reviewer #3: This an important systematic review of the evidence linking psychological safety and patient safety. The results will be of great interest to specialists in the patient safety domain. I think the manuscript could be greatly improved if the authors were to present their review from a different stance. Rather than presenting a list of the findings of the nine studies, I suggest a more nuanced approach which recognises the complexity of the link between the two entities. We know already that healthcare teams with high psych safety can appear to be operating less safely because they tend to report more patient safety incidents and unsafe practices. This could be the main focus of the research rather than a straight forward yes/no research question. The sections towards the end of the manuscript nicely address this and they could be moved to the beginning of the manuscript as the background to the review.

I think the results section should tell a 'story' rather than a 'a laundry list' of study findings. The study findings could be used as evidence for the 'story'. This would address an issue in the content where the authors report the study findings and then make a conclusion. It would be more interesting to reverse this process.

In my view (a) and (b) in the research question are not necessary and take from the impact of the question itself.

I also have some typos and writing style issues spotted which I hope are helpful:

The 0-10 rule is inconsistently applied. i.e. numbers between 0-10 should be written in long hand (abstract and L139, 8/9 7/9 etc )

L57, Should 'of' be deleted ?

Ideally sentences that begin with XXXXX found/demonstrated ........are not ideal....Instead state the finding and include the author reference at the end where possible

L 151 inconsistent use of capital letters

L92 rewrite' Therefore the direction or existence of causality between patient and PS is not clear'

Psychological safety is shortened early on to PS but this is not then used consistently ie Lines 96,207,209,214,228,255,256,259,262,264,268,270,273,274,277,282,296,304,307,318,325,330,331,334,337,336,337,338. Personally I prefer the phrase rather than the acronym as its easier for the reader.

L 225 paper or papers ?

I would love to see this manuscript published as it would add value to the body of knowledge if it was to be rewritten more creatively.

**********

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Reviewer #1: No

Reviewer #2: No

Reviewer #3: Yes:  Eva Doherty

**********

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PLoS One. 2025 Apr 24;20(4):e0322215. doi: 10.1371/journal.pone.0322215.r003

Author response to Decision Letter 1


23 Jan 2025

Response to reviewers

Dear Dr. Connolly and Reviewers,

We want to thank you and the three reviewers for their constructive feedback on our paper. Their suggestions improved the paper. In the following letter, we address all three reviewers' comments in detail and provide a revised manuscript using ‘track changes’ to indicate where the paper has changed.

Reviewer #1

1. Major: The problem analysis does not fit the research question. Bade on the introduction, the reader expects the paper to focus on the complex relationship between PS and outcomes and especially the underlying mechanisms. Instead the paper focuses on the evidence of the relationship and its implications for interventions.

Our Response: We have rewritten the introduction section to better reflect the complex relationship between PS and various outcomes.

2. Following the introduction, the research question should be wider and especially include the subjective patient safety outcomes in order to unravel this complex relationship. OR the introduction should be complete rewritten in order to focus on why we need a summary of evidence for this specific relationship, why is it so important to show the reader this overview of evidence. In addition, also argue why this overview does not include the subjective safety outcomes.

Our response: Previous systematic reviews on psychological safety in healthcare (i.e., Grailey et al, 2021; O’Donovan & McAuliffe, 2020) have reviewed papers that reported on the relationship between psychological safety and self-reported outcomes. However, it is widely acknowledged that self-report survey measures are limited by self-report bias and response fatigue (Donaldson & Grant-Vallone, 2002: Newman et al, 2017). Moreover, there is evidence that self-reports can artificially inflate the relationship between safety climate and safety outcomes (Beus et al., 2010), whereas evaluations of hospital patient safety performance (as well as fines, suspensions and closures) are based on objectively reported metrics (e.g., medical errors, critical incidents). Our aim in this paper was to provide a new contribution to the field in line with the current literature highlighting the complexity of defining patient safety and the need for updated approaches to patient safety definitions. Thus, we focused on studies that reported the relationship between PS and objective/robust measures of patient safety. Recent reviews of the PS area report on the positive significant relationships between high levels of psychological safety with learning and creativity outcomes (e.g., Edmondson & Bransby, 2023). However, this trend is not observed in healthcare (we cite the relevant research in our introduction). Therefore, we believe that a review of the evidence on the relationship between psychological safety and objective measures of patient safety would provide a new and needed addition to the literature. We hope that the reviewer agrees with our sentiments. We would also like to add that our collective experiences of teaching healthcare professionals indicate a desire from healthcare workers to be informed of the evidence concerning the impact of psychological safety on patient safety ‘in practice’.

References

Beus JM, Payne SC, Bergman ME, Arthur Jr W. Safety climate and injuries: an examination of theoretical and empirical relationships. Journal of applied psychology. 2010 Jul;95(4):713.

Donaldson SI, Grant-Vallone EJ. Understanding self-report bias in organizational behavior research. J Bus Psychol 2002;17:245–60.

Edmondson AC, Bransby DP. Psychological safety comes of age: observed themes in an established literature. Annual Review of Organizational Psychology and Organizational Behavior. 2023 Feb 2;10(1).

Grailey KE, Murray E, Reader T, Brett SJ. The presence and potential impact of psychological safety in the healthcare setting: an evidence synthesis. BMC health services research. 2021 Dec;21:1-5.

Newman A, Donohue R, Eva N. Psychological safety: a systematic review of the literature. Hum Resour Manag Rev 2017;27:521–35.

O’donovan R, Mcauliffe E. A systematic review of factors that enable psychological safety in healthcare teams. International journal for quality in health care. 2020 May;32(4):240-50.

3. Minor: Why is there a heading called “psychological safety and psychological safety”

Our response: Thank you for pointing this out. Apologies, we have corrected this typo.

4. Methods: In the future you might consider using tools to assist you in a systematic review, such as Ryyan or ASreview

Our response: We agree with the point of the reviewer. However, please note that we did use Rayyan in our review process. See - “Eligibility Criteria and Study Selection,” “Duplicate control and title and abstract review were conducted using Rayyan”.

5. You might consider identifying other reviews on PS. What did and didn't they conclude. Did they also include your selection of papers. Have you identified new papers or was this review also be able to be conducted based on the present reviews?

Our response: We have cited and included a large number of reviews on PS in our paper (see list below). The papers were useful in identifying the gaps in the literature. We highlight in the introduction the added value of our paper – in that it addresses an area that has not been previously covered in the literature. As we have previously mentioned in point 2, review papers to date have highlighted the problem surrounding the overreliance on self-report measures in terms of common method variance.

Here is a list of the included review papers in our manuscript:

Edmondson AC, Lei Z. Psychological safety: The history, renaissance, and future of an interpersonal construct. Annual Review of Organizational Psychology and Organizational Behavior. 2014 Mar 21;1(1):23–43.

Edmondson AC, Bransby DP. Psychological safety comes of age: observed themes in an established literature. Annual Review of Organizational Psychology and Organizational Behavior. 2023 Feb 2;10(1).

Frazier ML, Fainshmidt S, Klinger RL, Pezeshkan A, Vracheva V. Psychological safety: A meta-analytic review and extension. Personnel Psychology. 2017 Oct 14;70(1):113–65.

Grailey KE, Murray E, Reader T, Brett SJ. The presence and potential impact of psychological safety in the healthcare setting: an evidence synthesis. BMC health services research [Internet]. 2021 Aug 5 [cited 2021 Nov 4];21(1):773.

Liu JW, Ein N, Plouffe RA, Gervasio J, St. Cyr K, Nazarov A, Richardson JD. Meta-Analysis and Systematic Review of the Measures of Psychological Safety. medRxiv. 2024:2024-02.

O’donovan R, Mcauliffe E. A systematic review of factors that enable psychological safety in healthcare teams. International Journal for Quality in Health Care. 2020 Mar 31;32(4):240–50.

6. Results: - In the interpretation of the relationship there is a lack of nuanced. If a relationship between PS and medical errors is found, this means that people are more or less willing to report errors, it is not the same as the actual errors made. One could argue both ways: high PS could make the reporting of errors less urging and therefore lower OR high PS could make the reporting of errors more natural in an open and learning environment. This is somewhat later on discussed but not incorporated in the presentation of the results at the beginning of the Result section.

Our response: We thank the reviewer for the opportunity to improve the quality of the Results section. We have now addressed the difficulties of a “straightforward interpretation” at the beginning of the Result section entitled - (“Is there a relationship between Psychological Safety and Patient Safety?) section”.

We have included the following text: “PS and positive objective patient safety outcomes are sometimes “difficult” to detect and resistant to linear interpretation, as PS seems to share contextual dependencies between objective reporting behavior and patient safety. Additionally, high reporting rates may indicate high PS, where incidents are openly discussed and used as learning opportunities and protocol compliance. Conversely, low reporting rates might be interpreted as evidence of enhanced team performance, although this could also reflect underreporting or fear of disclosure.”

7. There is a lack of insights presented in teamwork in healthcare. People that filled in the questionnaire of Edmondons are healthcare professionals. They are part of multiple teams; multi teammembership. What are the teams we are referring to in the result section. Are that the multidisciplinairy teams that provide care? Or the monodisciplinairy teams? That is a big difference in relation to PS. In multidisciplinairy teams the different disciplines are stables but not the people representing this discipline.

Our response: We agree with the point of the reviewer. We do mention this as one of the limitations of the Edmondson questionnaire (see our section on Methodology and Sampling Issues), in that it's not possible to know what ‘team’ respondents have in mind when they fill in the questionnaire. The teamwork element is an important factor in this story, but our review of the nine papers did not allow us to reach any substantive conclusions on this issue.

8. Discussion/conclusion: What is the answer to the second part of the research question? Not clear what this review adds. The paradoxes where already know prior to the research. Make clear what we did not know and after the review do know. After rewriting the introduction, have in mind that the introduction and discussion should cover other angles. Now they are too similar in their message.

Our response: We hope that our rewriting of the paper has illuminated more clearly what our review has contributed to the field. We agree with the reviewer that the paradoxes were already mentioned in the literature, however – we would argue that our paper is the first attempt to review the paradox between PS and patient safety in detail. Beyond this, we can provide a clearer description of what our paper contributes:

What is already known on this topic – High levels of psychological safety in healthcare teams has been advocated as an important mechanism by which patient safety can be improved. However, the majority of the research is based on self-report measures.

What this study adds – This is the first systematic review to assess the relationship between psychological safety and objectively measured patient safety. It identifies that commonly used definitions of patient safety as simply the absence of harm, might need to broaden to concepts of contemporary safety science.

How this study might affect research, practice or policy – High levels of psychological safety has been advocated as an important mechanism by which patient safety can be improved, but there is insufficient evidence to support this idea due to the framing of safety only as the absence of harm in the healthcare literature, rather than a safety science lens

Reviewer #2:

1. This is a really interesting and important paper and congratulations to the authors. The comments made here are in the spirit of strengthening the paper.

Our response: We appreciate the reviewer’s perspective, and we thank for the positive appraisal of the revised manuscript, as well as for the opportunity to further enhance the quality of the paper.

2. The definition of psychological safety is important. Edmondson’s 1999 definition and measurement is not just about me being able to take risks (express vulnerability) in relation to what I do and do not know but also relates to me being able to question my colleagues on their actions and how correct/safe they are. E.g. it is an important point made in the introduction that in healthcare a lot of time is spent trying to figure out what is safe to talk about – but is this not what psychological safety is about?

Our response: We agree with the point of the reviewer that the Edmondson approach is about taking risks but also relates to speaking up to colleagues. We acknowledge this problem in terms of our discussion of the inherent challenges in using the Edmondson questionnaire and what it means for the validity of psychological safety. For example, we mention the problem of what individuals have in mind when thinking about what ‘team’ the questionnaire refers to. Additionally, we note the reliability and unidimensional limitations of the Edmondson questionnaire. The point about speaking up is an important one, but the available research evidence in organizational behaviour literature tends to treat employee silence and employee voice as distinct constructs from psychological safety. However, this is a bigger problem concerning silence and voice in healthcare per se, with a recent integrative review indicating a need for further research regarding the distinction between what drives safety voice versus general employee voice, and how both voice and silence can operate in parallel in healthcare (Lainidi et al, 2023). We agree with the reviewer that a lack of psychological safety means either uncertainty on whether doing the right thing will be accepted or even certainty that other issues (e.g., the reputation of the unit/hospital) should be prioritised over doing the right thing by e.g., the patients. In that sense, speaking up can be included under the “taking a risk” umbrella. In practical terms, healthcare professionals might experience the high levels psychological safety in their team/unit, while also knowing there are certain topics that should not be voiced.

Lainidi O, Jendeby MK, Montgomery A, Mouratidis C, Paitaridou K, Cook C, Johnson J, Karakasidou E. An integrative systematic review of employee silence and voice in healthcare: what are we really measuring?. Frontiers in Psychiatry. 2023 May 25;14:1111579.

3. There are more nuanced definitions of patient safety other than freedom from harm and as you argue this is not a good definition. I think these other definitions informed by Safety Management Systems work in aviation and other fields should also be included here?

Our response: We thank the reviewer for this suggestion. We have now extended the definition to state: “Defining the commitment to advancing safe care, patient safety—the most enduring and foundational principle of medicine—represents the core value of healthcare quality by emphasizing freedom from any harm associated with health care in clinical practices.”

4. Section – Psychological safety and should be ‘patient’ safety?

Our response: Thank you for pointing this out. Apologies, we have corrected this typo.

5. Line 80 - Medical errors third leading cause of death – needs to be nuanced. https://qualitysafety.bmj.com/content/26/5/423

Our response: We thank the reviewer for this advice. We have now corrected the percentage to “Medical errors are translating into over three million deaths globally each year” as reported in Global patient safety report 2024. Geneva: World Health Organization; 2024.

6. Lines 85-90 Should psychological safety not also lead to increased reporting of adverse events and to increased challenges to each other on unsafe practices?

Our response: We thank the reviewer for raising this crucial point. In healthcare, where professionals are highly trained and educated, psychological safety should lead to increased reporting of adverse events/incidents/errors and more frequent challenges to unsafe practices only when healthcare professionals perceive reporting as a constructive action aimed at improving patient safety and delivering high-quality care, rather than as an admission of personal failure or accountability. However, this association seems to be quite complex as psychological safety could also lead to decreased reporting of adverse events/incidents/errors, while also there is not concrete evidence on “how much” psychological safety is needed or whether too much psychological safety can lead to unnecessary risks or aversion towards formal reporting. We agree with this point and it links to the reviewer’s earlier comment on what psychological safety is – and this point indirectly implies that academics and practitioners might need to think what is NOT psychological safety. To address this, in the Results section (at the beginning of - Is there a relationship b

Attachment

Submitted filename: Response to reviewers.docx

pone.0322215.s008.docx (34.1KB, docx)

Decision Letter 1

Wen Wu

16 Feb 2025

PONE-D-24-42345R1Psychological safety and patient safety: a systematic and narrative reviewPLOS ONE

Dear Dr. Montgomery,

Thank you for submitting your manuscript to PLOS ONE. After careful consideration, we feel that it has merit but does not fully meet PLOS ONE’s publication criteria as it currently stands. Therefore, we invite you to submit a revised version of the manuscript that addresses the points raised during the review process.

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We look forward to receiving your revised manuscript.

Kind regards,

Wen Wu, phd

Academic Editor

PLOS ONE

Additional Editor Comments:

Dear Authors,

Thanks for your effort in revising the last version of the manuscript. I have carefully read the whole submission. Generally, I agree with the feedback from three reviewers. Their comments are varied, ranging from major and minor revisions. I give you the opportunity to revise and resubmit the manuscript. They pointed out that this research project is interesting and significant (R 2 &3). However, they mentioned lots of weaknesses you have to solve. For instance, the introduction should be improved. And the significance of your research in healthcare context should be further shown. I hope you can respond to their comments one by one, and make detailed improvement in the manuscript in the next round.

Reviewer 1:

Introduction:

- Major: The problem analysis does not fit the research question. Bade on the introduction, the reader expects the paper to focus on the complex relationship between PS and outcomes and especially the underlying mechanisms. Instead the paper focuses on the evidence of the relationship and its implications for interventions. Following the introduction, the research question should be wider and especially include the subjective patient safety outcomes in order to unravel this complex relationship. OR the introduction should be complete rewritten in order to focus on why we need a summary of evidence for this specific relationship, why is it so important to show the reader this overview of evidence. In addition, also argue why this overview does not include the subjective safety outcomes.

- Minor: Why is there a heading called “psychological safety and psychological safety”

Methods:

- In the future you might consider using tools to assist you in a systematic review, such as Ryyan or ASreview

- You might consider identifying other reviews on PS. What did and didn't they conclude. Did they also include your selection of papers. Have you identified new papers or was this review also be able to be conducted based on the present reviews?

Results:

- In the interpretation of the relationship there is a lack of nuanced. If a relationship between PS and medical errors is found, this means that people are more or less willing to report errors, it is not the same as the actual errors made. One could argue both ways: high PS could make the reporting of errors less urging and therefore lower OR high PS could make the reporting of errors more natural in an open and learning environment. This is somewhat later on discussed but not incorporated in the presentation of the results at the beginning of the Result section.

- There is a lack of insights presented in teamwork in healthcare. People that filled in the questionnaire of Edmondons are healthcare professionals. They are part of multiple teams; multi teammembership. What are the teams we are referring to in the result section. Are that the multidisciplinairy teams that provide care? Or the monodisciplinairy teams? That is a big difference in relation to PS. In multidisciplinairy teams the different disciplines are stables but not the people representing this discipline.

Discussion/conclusion:

- What is the answer to the second part of the research question?

- Not clear what this review adds. The paradoxes where already know prior to the research. Make clear what we did not know and after the review do know.

- After rewriting the introduction, have in mind that the introduction and discussion should cover other angles. Now they are too similar in their message.

Reviewer 2:

This is a really interesting and important paper and congratulations to the authors. The comments made here are in the spirit of strengthening the paper.

The definition of psychological safety is important. Edmondson’s 1999 definition and measurement is not just about me being able to take risks (express vulnerability) in relation to what I do and do not know but also relates to me being able to question my colleagues on their actions and how correct/safe they are. E.g. it is an important point made in the introduction that in healthcare a lot of time is spent trying to figure out what is safe to talk about – but is this not what psychological safety is about?

There are more nuanced definitions of patient safety other than freedom from harm and as you argue this is not a good definition. I think these other definitions informed by Safety Management Systems work in aviation and other fields should also be included here?

Section – Psychological safety and should be ‘patient’ safety?

Line 80 - Medical errors third leading cause of death – needs to be nuanced

https://qualitysafety.bmj.com/content/26/5/423

Lines 85-90 Should psychological safety not also lead to increased reporting of adverse events and to increased challenges to each other on unsafe practices?

Methods

Search strategy

Line 112 – why were only quantitative studies included – needs justification

Results

Line 138 not sure why female participants pulled out in particular – would it be more appropriate to say ‘Only 4 out of 9 studies noted gender of participants’.

Line 142 needs more discussion on what tools other than Edmondson were used.

Discussion

Line 279 – or improved objective patient safety measures (rather than just formal reporting or errors?) and what are these?

Reviewer 3:

This an important systematic review of the evidence linking psychological safety and patient safety. The results will be of great interest to specialists in the patient safety domain. I think the manuscript could be greatly improved if the authors were to present their review from a different stance. Rather than presenting a list of the findings of the nine studies, I suggest a more nuanced approach which recognises the complexity of the link between the two entities. We know already that healthcare teams with high psych safety can appear to be operating less safely because they tend to report more patient safety incidents and unsafe practices. This could be the main focus of the research rather than a straight forward yes/no research question. The sections towards the end of the manuscript nicely address this and they could be moved to the beginning of the manuscript as the background to the review.

I think the results section should tell a 'story' rather than a 'a laundry list' of study findings. The study findings could be used as evidence for the 'story'. This would address an issue in the content where the authors report the study findings and then make a conclusion. It would be more interesting to reverse this process.

In my view (a) and (b) in the research question are not necessary and take from the impact of the question itself.

I also have some typos and writing style issues spotted which I hope are helpful:

The 0-10 rule is inconsistently applied. i.e. numbers between 0-10 should be written in long hand (abstract and L139, 8/9 7/9 etc )

L57, Should 'of' be deleted ?

Ideally sentences that begin with XXXXX found/demonstrated ........are not ideal....Instead state the finding and include the author reference at the end where possible

L 151 inconsistent use of capital letters

L92 rewrite' Therefore the direction or existence of causality between patient and PS is not clear'

Psychological safety is shortened early on to PS but this is not then used consistently ie Lines 96,207,209,214,228,255,256,259,262,264,268,270,273,274,277,282,296,304,307,318,325,330,331,334,337,336,337,338. Personally I prefer the phrase rather than the acronym as its easier for the reader.

L 225 paper or papers ?

I would love to see this manuscript published as it would add value to the body of knowledge if it was to be rewritten more creatively.

[Note: HTML markup is below. Please do not edit.]

Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. If the authors have adequately addressed your comments raised in a previous round of review and you feel that this manuscript is now acceptable for publication, you may indicate that here to bypass the “Comments to the Author” section, enter your conflict of interest statement in the “Confidential to Editor” section, and submit your "Accept" recommendation.

Reviewer #2: All comments have been addressed

Reviewer #3: (No Response)

**********

2. Is the manuscript technically sound, and do the data support the conclusions?

The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented.

Reviewer #2: (No Response)

Reviewer #3: Yes

**********

3. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #2: (No Response)

Reviewer #3: N/A

**********

4. Have the authors made all data underlying the findings in their manuscript fully available?

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified.

Reviewer #2: (No Response)

Reviewer #3: Yes

**********

5. Is the manuscript presented in an intelligible fashion and written in standard English?

PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here.

Reviewer #2: (No Response)

Reviewer #3: No

**********

6. Review Comments to the Author

Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #2: (No Response)

Reviewer #3: Thankyou for re-arranging the text of the manuscript and for your responses to the points made. Unfortunately I can see some pronouns are still missing (eg L 40 in the abstract 'are' is missing before the 'from the USA.) Psychological safety is writtenin full on L 84.'a' is missing on L86. there are others too numerous to list.In addition both american and English spelling is used. eg organizational vs characterised. There are commas missing in lots of sentences and many of the sentences in the introduction and elsewhere are too long and need to be broken up so that you bring the reader with you in your statements.

**********

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Reviewer #2: No

Reviewer #3: No

**********

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PLoS One. 2025 Apr 24;20(4):e0322215. doi: 10.1371/journal.pone.0322215.r005

Author response to Decision Letter 2


17 Feb 2025

Dear Dr. Wan and Reviewers,

We want to thank you and the three reviewers for their constructive feedback on our paper. Their suggestions improved the paper. In the following letter, we address all three reviewers' comments in detail and provide a revised manuscript using ‘track changes’ to indicate where the paper has changed.

Reviewer #1

1. Major: The problem analysis does not fit the research question. Bade on the introduction, the reader expects the paper to focus on the complex relationship between PS and outcomes and especially the underlying mechanisms. Instead the paper focuses on the evidence of the relationship and its implications for interventions.

Our Response: We have rewritten the introduction section to better reflect the complex relationship between PS and various outcomes.

2. Following the introduction, the research question should be wider and especially include the subjective patient safety outcomes in order to unravel this complex relationship. OR the introduction should be complete rewritten in order to focus on why we need a summary of evidence for this specific relationship, why is it so important to show the reader this overview of evidence. In addition, also argue why this overview does not include the subjective safety outcomes.

Our response: Previous systematic reviews on psychological safety in healthcare (i.e., Grailey et al, 2021; O’Donovan & McAuliffe, 2020) have reviewed papers that reported on the relationship between psychological safety and self-reported outcomes. However, it is widely acknowledged that self-report survey measures are limited by self-report bias and response fatigue (Donaldson & Grant-Vallone, 2002: Newman et al, 2017). Moreover, there is evidence that self-reports can artificially inflate the relationship between safety climate and safety outcomes (Beus et al., 2010), whereas evaluations of hospital patient safety performance (as well as fines, suspensions and closures) are based on objectively reported metrics (e.g., medical errors, critical incidents). Our aim in this paper was to provide a new contribution to the field in line with the current literature highlighting the complexity of defining patient safety and the need for updated approaches to patient safety definitions. Thus, we focused on studies that reported the relationship between PS and objective/robust measures of patient safety. Recent reviews of the PS area report on the positive significant relationships between high levels of psychological safety with learning and creativity outcomes (e.g., Edmondson & Bransby, 2023). However, this trend is not observed in healthcare (we cite the relevant research in our introduction). Therefore, we believe that a review of the evidence on the relationship between psychological safety and objective measures of patient safety would provide a new and needed addition to the literature. We hope that the reviewer agrees with our sentiments. We would also like to add that our collective experiences of teaching healthcare professionals indicate a desire from healthcare workers to be informed of the evidence concerning the impact of psychological safety on patient safety ‘in practice’.

References

Beus JM, Payne SC, Bergman ME, Arthur Jr W. Safety climate and injuries: an examination of theoretical and empirical relationships. Journal of applied psychology. 2010 Jul;95(4):713.

Donaldson SI, Grant-Vallone EJ. Understanding self-report bias in organizational behavior research. J Bus Psychol 2002;17:245–60.

Edmondson AC, Bransby DP. Psychological safety comes of age: observed themes in an established literature. Annual Review of Organizational Psychology and Organizational Behavior. 2023 Feb 2;10(1).

Grailey KE, Murray E, Reader T, Brett SJ. The presence and potential impact of psychological safety in the healthcare setting: an evidence synthesis. BMC health services research. 2021 Dec;21:1-5.

Newman A, Donohue R, Eva N. Psychological safety: a systematic review of the literature. Hum Resour Manag Rev 2017;27:521–35.

O’donovan R, Mcauliffe E. A systematic review of factors that enable psychological safety in healthcare teams. International journal for quality in health care. 2020 May;32(4):240-50.

3. Minor: Why is there a heading called “psychological safety and psychological safety”

Our response: Thank you for pointing this out. Apologies, we have corrected this typo.

4. Methods: In the future you might consider using tools to assist you in a systematic review, such as Ryyan or ASreview

Our response: We agree with the point of the reviewer. However, please note that we did use Rayyan in our review process. See - “Eligibility Criteria and Study Selection,” “Duplicate control and title and abstract review were conducted using Rayyan”.

5. You might consider identifying other reviews on PS. What did and didn't they conclude. Did they also include your selection of papers. Have you identified new papers or was this review also be able to be conducted based on the present reviews?

Our response: We have cited and included a large number of reviews on PS in our paper (see list below). The papers were useful in identifying the gaps in the literature. We highlight in the introduction the added value of our paper – in that it addresses an area that has not been previously covered in the literature. As we have previously mentioned in point 2, review papers to date have highlighted the problem surrounding the overreliance on self-report measures in terms of common method variance.

Here is a list of the included review papers in our manuscript:

Edmondson AC, Lei Z. Psychological safety: The history, renaissance, and future of an interpersonal construct. Annual Review of Organizational Psychology and Organizational Behavior. 2014 Mar 21;1(1):23–43.

Edmondson AC, Bransby DP. Psychological safety comes of age: observed themes in an established literature. Annual Review of Organizational Psychology and Organizational Behavior. 2023 Feb 2;10(1).

Frazier ML, Fainshmidt S, Klinger RL, Pezeshkan A, Vracheva V. Psychological safety: A meta-analytic review and extension. Personnel Psychology. 2017 Oct 14;70(1):113–65.

Grailey KE, Murray E, Reader T, Brett SJ. The presence and potential impact of psychological safety in the healthcare setting: an evidence synthesis. BMC health services research [Internet]. 2021 Aug 5 [cited 2021 Nov 4];21(1):773.

Liu JW, Ein N, Plouffe RA, Gervasio J, St. Cyr K, Nazarov A, Richardson JD. Meta-Analysis and Systematic Review of the Measures of Psychological Safety. medRxiv. 2024:2024-02.

O’donovan R, Mcauliffe E. A systematic review of factors that enable psychological safety in healthcare teams. International Journal for Quality in Health Care. 2020 Mar 31;32(4):240–50.

6. Results: - In the interpretation of the relationship there is a lack of nuanced. If a relationship between PS and medical errors is found, this means that people are more or less willing to report errors, it is not the same as the actual errors made. One could argue both ways: high PS could make the reporting of errors less urging and therefore lower OR high PS could make the reporting of errors more natural in an open and learning environment. This is somewhat later on discussed but not incorporated in the presentation of the results at the beginning of the Result section.

Our response: We thank the reviewer for the opportunity to improve the quality of the Results section. We have now addressed the difficulties of a “straightforward interpretation” at the beginning of the Result section entitled - (“Is there a relationship between Psychological Safety and Patient Safety?) section”.

We have included the following text: “PS and positive objective patient safety outcomes are sometimes “difficult” to detect and resistant to linear interpretation, as PS seems to share contextual dependencies between objective reporting behavior and patient safety. Additionally, high reporting rates may indicate high PS, where incidents are openly discussed and used as learning opportunities and protocol compliance. Conversely, low reporting rates might be interpreted as evidence of enhanced team performance, although this could also reflect underreporting or fear of disclosure.”

7. There is a lack of insights presented in teamwork in healthcare. People that filled in the questionnaire of Edmondons are healthcare professionals. They are part of multiple teams; multi teammembership. What are the teams we are referring to in the result section. Are that the multidisciplinairy teams that provide care? Or the monodisciplinairy teams? That is a big difference in relation to PS. In multidisciplinairy teams the different disciplines are stables but not the people representing this discipline.

Our response: We agree with the point of the reviewer. We do mention this as one of the limitations of the Edmondson questionnaire (see our section on Methodology and Sampling Issues), in that it's not possible to know what ‘team’ respondents have in mind when they fill in the questionnaire. The teamwork element is an important factor in this story, but our review of the nine papers did not allow us to reach any substantive conclusions on this issue.

8. Discussion/conclusion: What is the answer to the second part of the research question? Not clear what this review adds. The paradoxes where already know prior to the research. Make clear what we did not know and after the review do know. After rewriting the introduction, have in mind that the introduction and discussion should cover other angles. Now they are too similar in their message.

Our response: We hope that our rewriting of the paper has illuminated more clearly what our review has contributed to the field. We agree with the reviewer that the paradoxes were already mentioned in the literature, however – we would argue that our paper is the first attempt to review the paradox between PS and patient safety in detail. Beyond this, we can provide a clearer description of what our paper contributes:

What is already known on this topic – High levels of psychological safety in healthcare teams has been advocated as an important mechanism by which patient safety can be improved. However, the majority of the research is based on self-report measures.

What this study adds – This is the first systematic review to assess the relationship between psychological safety and objectively measured patient safety. It identifies that commonly used definitions of patient safety as simply the absence of harm, might need to broaden to concepts of contemporary safety science.

How this study might affect research, practice or policy – High levels of psychological safety has been advocated as an important mechanism by which patient safety can be improved, but there is insufficient evidence to support this idea due to the framing of safety only as the absence of harm in the healthcare literature, rather than a safety science lens

Reviewer #2:

1. This is a really interesting and important paper and congratulations to the authors. The comments made here are in the spirit of strengthening the paper.

Our response: We appreciate the reviewer’s perspective, and we thank for the positive appraisal of the revised manuscript, as well as for the opportunity to further enhance the quality of the paper.

2. The definition of psychological safety is important. Edmondson’s 1999 definition and measurement is not just about me being able to take risks (express vulnerability) in relation to what I do and do not know but also relates to me being able to question my colleagues on their actions and how correct/safe they are. E.g. it is an important point made in the introduction that in healthcare a lot of time is spent trying to figure out what is safe to talk about – but is this not what psychological safety is about?

Our response: We agree with the point of the reviewer that the Edmondson approach is about taking risks but also relates to speaking up to colleagues. We acknowledge this problem in terms of our discussion of the inherent challenges in using the Edmondson questionnaire and what it means for the validity of psychological safety. For example, we mention the problem of what individuals have in mind when thinking about what ‘team’ the questionnaire refers to. Additionally, we note the reliability and unidimensional limitations of the Edmondson questionnaire. The point about speaking up is an important one, but the available research evidence in organizational behaviour literature tends to treat employee silence and employee voice as distinct constructs from psychological safety. However, this is a bigger problem concerning silence and voice in healthcare per se, with a recent integrative review indicating a need for further research regarding the distinction between what drives safety voice versus general employee voice, and how both voice and silence can operate in parallel in healthcare (Lainidi et al, 2023). We agree with the reviewer that a lack of psychological safety means either uncertainty on whether doing the right thing will be accepted or even certainty that other issues (e.g., the reputation of the unit/hospital) should be prioritised over doing the right thing by e.g., the patients. In that sense, speaking up can be included under the “taking a risk” umbrella. In practical terms, healthcare professionals might experience the high levels psychological safety in their team/unit, while also knowing there are certain topics that should not be voiced.

Lainidi O, Jendeby MK, Montgomery A, Mouratidis C, Paitaridou K, Cook C, Johnson J, Karakasidou E. An integrative systematic review of employee silence and voice in healthcare: what are we really measuring?. Frontiers in Psychiatry. 2023 May 25;14:1111579.

3. There are more nuanced definitions of patient safety other than freedom from harm and as you argue this is not a good definition. I think these other definitions informed by Safety Management Systems work in aviation and other fields should also be included here?

Our response: We thank the reviewer for this suggestion. We have now extended the definition to state: “Defining the commitment to advancing safe care, patient safety—the most enduring and foundational principle of medicine—represents the core value of healthcare quality by emphasizing freedom from any harm associated with health care in clinical practices.”

4. Section – Psychological safety and should be ‘patient’ safety?

Our response: Thank you for pointing this out. Apologies, we have corrected this typo.

5. Line 80 - Medical errors third leading cause of death – needs to be nuanced. https://qualitysafety.bmj.com/content/26/5/423

Our response: We thank the reviewer for this advice. We have now corrected the percentage to “Medical errors are translating into over three million deaths globally each year” as reported in Global patient safety report 2024. Geneva: World Health Organization; 2024.

6. Lines 85-90 Should psychological safety not also lead to increased reporting of adverse events and to increased challenges to each other on unsafe practices?

Our response: We thank the reviewer for raising this crucial point. In healthcare, where professionals are highly trained and educated, psychological safety should lead to increased reporting of adverse events/incidents/errors and more frequent challenges to unsafe practices only when healthcare professionals perceive reporting as a constructive action aimed at improving patient safety and delivering high-quality care, rather than as an admission of personal failure or accountability. However, this association seems to be quite complex as psychological safety could also lead to decreased reporting of adverse events/incidents/errors, while also there is not concrete evidence on “how much” psychological safety is needed or whether too much psychological safety can lead to unnecessary risks or aversion towards formal reporting. We agree with this point and it links to the reviewer’s earlier comment on what psychological safety is – and this point indirectly implies that academics and practitioners might need to think what is NOT psychological safety. To address this, in the Results section (at the beginning of - Is there a relationship between Psychological Safety an

Attachment

Submitted filename: Response_to_reviewers_auresp_2.docx

pone.0322215.s009.docx (34.1KB, docx)

Decision Letter 2

Wen Wu

18 Mar 2025

Psychological safety and patient safety: a systematic and narrative review

PONE-D-24-42345R2

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Reviewer #1: Thank you for addressing all the comments. You have done a great job in commenting all comments and adjusting the manuscript accordingly.

Reviewer #2: (No Response)

Reviewer #3: There are still a number of grammatical issues and spelling inconsistencies which at the third phase of the review process should have been corrected. In the abstract, 8 databases should be eight databases.

L65 'not cover up' should be replaced with 'report/declare/expose. There is a full stop missing after [9,10]. This should be followed by a new sentence as the sentence is too long.

American and English spelling is still in evidence

L66 organisational

L35 analyzed

L79 behaviours vs L53 behaviors

L84 psychological safety rather than PS

L116 emphasizing

L118 recognising

L119 full stop missing after [29]

L145 summarize

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Acceptance letter

Wen Wu

PONE-D-24-42345R2

PLOS ONE

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Associated Data

    This section collects any data citations, data availability statements, or supplementary materials included in this article.

    Supplementary Materials

    S1 File. PRISMA checklist.

    (DOCX)

    pone.0322215.s001.docx (32.1KB, docx)
    S2 File. Search strings.

    (DOCX)

    pone.0322215.s002.docx (24.5KB, docx)
    S3 File. Inclusion-exclusion criteria.

    (DOCX)

    pone.0322215.s003.docx (14.3KB, docx)
    S4 File. Reasons for exclusion.

    (PDF)

    pone.0322215.s004.pdf (171.1KB, pdf)
    S5 File. Extracted data.

    (PDF)

    pone.0322215.s005.pdf (241.7KB, pdf)
    S6 File. Quality assessment.

    (PDF)

    pone.0322215.s006.pdf (88.9KB, pdf)
    Attachment

    Submitted filename: Response to reviewers.docx

    pone.0322215.s008.docx (34.1KB, docx)
    Attachment

    Submitted filename: Response_to_reviewers_auresp_2.docx

    pone.0322215.s009.docx (34.1KB, docx)

    Data Availability Statement

    All relevant data are within the manuscript and its Supporting Information files.


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