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importance of safety case study

Injuries and Illness

Case studies in safety: a great training tool.

Updated: Nov 6, 2011

Case studies are a great safety training tool. It’s like CSI. Employees can really get involved examining the evidence and seeing why an accident occurred.

Safety case studies are fun, challenging, interactive, and a highly effective training method.

Armed with the knowledge they gain from examining the facts of real workplace accidents, workers can learn how to avoid similar incidents and injuries.

Here’s an example of such a case from BLR’s OSHA Accident Case Studies . This case is about a confined space incident.

The Incident

Two employees arrived at concrete pit at demolition site where they’d been working to salvage the bottom part of a cardboard baler imbedded in the pit. When the employees uncovered the pit, they both felt a burning sensation in their eyes.

Employee #1 climbed down into the pit to determine what might be causing their eyes to burn. He immediately climbed back out of the pit because it was hot. He decided to put a water hose into the pit to help cool it down.

The employees climbed down into the pit with the water hose. Both employees experienced chest tightness, difficulty breathing, and burning eyes. They decided to exit the pit because of the intolerable conditions.

Employee #2 climbed out first. As Employee #1 was climbing the ladder to get out, he was overcome by the fumes and fell back into the pit. He landed on his back, unconscious.

Employee #2 climbed down into the pit in an attempt to rescue employee #1, but was unable to lift him. Employee #2 exited the pit in order to get help. Unfortunately, by the time help arrived, Employee #1 had died of asphyxiation.

The accident investigation determined that employee #1 had attempted to extinguish a small cutting torch fire the day before by covering it with sand and dirt. Apparently the fire was not extinguished and smoldered overnight, which resulted in a build up of carbon monoxide inside the pit.

Try OSHA Accident Case Studies and give a boost to your safety training program with real-life case studies of actual industrial accidents from OSHA files. We have a great one on lifting. Get the details.

Discussion Questions

Once the case has been presented, some discussion questions can help kick off the analysis of the incident. For example:

  • What are the potential hazards of confined spaces?
  • What was the specific hazard in this case that cause a fatality?
  • Were these workers properly trained and equipped to enter a confined space?
  • What type of air monitoring should be done before entering a confined space?
  • Was this a permit-required confined space? If so, were the workers familiar with the safety requirements of the permit?
  • Was confined space rescue equipment readily accessible?
  • Training? There is no indication on the accident report that the employees were trained as authorized entrants of confined spaces. If they did receive any confined space entry training, they clearly didn’t apply what they learned. Authorized entrants are trained on the hazards of confined spaces, atmosphere testing procedures, symptoms of lack of oxygen or exposure to toxic chemicals, personal protective equipment (PPE), communication equipment, rescue retrieval equipment, etc.
  • Hazard warning? These employees entered the space despite experiencing "red flags," such burning eyes and unusual heat. An important part of training for confined space workers includes learning about hazards such as the symptoms of a lack of oxygen or exposure to toxic chemicals. Workers should never enter a space, and should immediately leave a space, in which they experience signs of hazardous conditions.

Even your most skeptical workers will see what can go wrong and become safety-minded employees with OSHA Accident Case Studies . They’ll learn valuable safety training lessons from real mistakes—but in classroom training meetings instead of on your shop floor. Get more info.

  • Permit-required? Most confined spaces require a permit before workers can enter the space. Permit-required confined spaces have the potential for hazards such as hazardous atmospheres, engulfment, entrapment, falls, heat, combustibility, etc. By reviewing a permit, entrants know they have obtained all the necessary equipment and the atmosphere has been monitored so they know the space is safe to enter.
  • Testing? This worker died of asphyxiation, or lack of oxygen. If the atmosphere in the pit had been tested prior to entry, this accident would not have occurred. Common monitoring practices require a check of the oxygen concentration, a check for flammable gases or vapors (especially important if welding is going to be done in the space), and finally, a check for any other toxic chemicals known to potentially be in the space. Monitoring is conducted before entering the space and periodically while workers are in the space.
  • Rescue procedures and equipment? The worker who collapsed back into the pit while climbing out could not be rescued because he was not wearing required rescue equipment. He should have been wearing a full-body harness attached to a retrieval line that was connected to a winch-type system that could have been used to pull the unconscious worker out of the pit. Of course, the other employee would have had to have been trained in confined space rescue procedures.

Tomorrow, we’ll introduce you to another case from OSHA Accident Case Studies, this one about a materials handling accident that resulted in a serious back injury.

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Case studies.

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Occupational and Environmental Safety and Health pp 757–764 Cite as

The Importance of Emergency Response Training: A Case Study

  • Ana Sofia Pinheiro 11 ,
  • Rui Gouveia 11 ,
  • Ângelo Jesus 12 ,
  • Joana Santos   ORCID: orcid.org/0000-0002-2777-3244 11 &
  • João S. Baptista   ORCID: orcid.org/0000-0002-8524-5503 13  
  • First Online: 28 February 2019

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Part of the Studies in Systems, Decision and Control book series (SSDC,volume 202)

The success of the Emergency Plan depends on the ability of its occupants to respond. For this reason, it is fundamental to develop an appropriate training strategy for each organization. This pilot study aimed to understand the influence of specific training program on the emergency response. This study included a total of twenty-two workers of a company. The workers were divided into three emergency response teams with four elements and one another group with ten elements. The emergency response team had specific training actions with theoretical and practical contents. Finally, all workers participated in an activity called emergency scenarios, where a moment of brainstorming was provided for the solve each scenario. The classifications obtained in different assessments moments (M1: after training and M2: after three weeks of training) revealed that knowledge had been acquired by participants. Additionally, it was verified that teams, with specific training, presented better results in their specific scenario. The emergency response training may have better results if it enhances teamwork and the involvement of all stakeholders.

  • Emergency response team

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Scientific Area of Environmental Health and Research Centre on Health and Environment (CISA), School of Health, Polytechnic Institute of Porto, Porto, Portugal

Ana Sofia Pinheiro, Rui Gouveia & Joana Santos

Research Centre on Health and Environment (CISA), School of Health, Polytechnic Institute of Porto, Porto, Portugal

Ângelo Jesus

Associated Laboratory for Energy, Transports and Aeronautics (PROA/LAETA), Faculty of Engineering, University of Porto, Porto, Portugal

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Patrício Cordeiro

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Pinheiro, A.S., Gouveia, R., Jesus, Â., Santos, J., Baptista, J.S. (2019). The Importance of Emergency Response Training: A Case Study. In: Arezes, P., et al. Occupational and Environmental Safety and Health. Studies in Systems, Decision and Control, vol 202. Springer, Cham. https://doi.org/10.1007/978-3-030-14730-3_79

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  • Published: 05 August 2021

The presence and potential impact of psychological safety in the healthcare setting: an evidence synthesis

  • K. E. Grailey 1 ,
  • E. Murray 2 ,
  • T. Reader 3 &
  • S. J. Brett 1  

BMC Health Services Research volume  21 , Article number:  773 ( 2021 ) Cite this article

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Introduction

Psychological safety is the shared belief that the team is safe for interpersonal risk taking. Its presence improves innovation and error prevention. This evidence synthesis had 3 objectives: explore the current literature regarding psychological safety, identify methods used in its assessment and investigate for evidence of consequences of a psychologically safe environment.

We searched multiple trial registries through December 2018. All studies addressing psychological safety within healthcare workers were included and reviewed for methodological limitations. A thematic analysis approach explored the presence of psychological safety. Content analysis was utilised to evaluate potential consequences.

We included 62 papers from 19 countries. The thematic analysis demonstrated high and low levels of psychological safety both at the individual level in study participants and across the studies themselves. There was heterogeneity in responses across all studies, limiting generalisable conclusions about the overall presence of psychological safety.

A wide range of methods were used. Twenty-five used qualitative methodology, predominantly semi-structured interviews. Thirty quantitative or mixed method studies used surveys.

Ten studies inferred that low psychological safety negatively impacted patient safety. Nine demonstrated a significant relationship between psychological safety and team outcomes.

The thematic analysis allowed the development of concepts beyond the content of the original studies. This analytical process provided a wealth of information regarding facilitators and barriers to psychological safety and the development of a model demonstrating the influence of situational context.

This evidence synthesis highlights that whilst there is a positive and demonstrable presence of psychological safety within healthcare workers worldwide, there is room for improvement. The variability in methods used demonstrates scope to harmonise this. We draw attention to potential consequences of both high and low psychological safety.

We provide novel information about the influence of situational context on an individual’s psychological safety and offer more detail about the facilitators and barriers to psychological safety than seen in previous reviews. There is a risk of participation bias - centres involved in safety research may be more aligned to these ideals. The data in this synthesis are useful for institutions looking to improve psychological safety by providing a framework from which modifiable factors can be identified.

Peer Review reports

Healthcare workers are required to operate in challenging and fast paced environments, where accurate decision making, error minimisation and innovation are essential in providing excellent patient care [ 1 , 2 ]. Psychological safety was originally defined in 1990 as an individual’s “sense of being able to show and employ oneself without fear of negative consequences to self-image, status or career” [ 3 ]. Psychological safety has been characterised further in the context of work teams as “a shared belief that the team is safe for interpersonal risk taking” [ 4 ].

An environment that is psychologically safe allows individuals to be their “true selves”. This can take the form of enhancing employee voice, commitment to the organisation and investment in patient care [ 5 ]. An individual that feels enabled to raise concerns, near misses and difficult issues can also help minimise the incidence of medical error [ 6 , 7 ].

The importance of psychological safety is not limited to the healthcare setting. Google explored this concept within “Project Aristotle” [ 8 ] – a 2-year project investigating the factors that made teams operate most effectively (exploring group dynamics, individual skill sets, personality traits and emotional intelligence). From this they developed a list of key dynamics making teams successful - with psychological safety at the top [ 8 ]. In industry, high levels of psychological safety can be associated with promoting moderate risk taking and creative breakthroughs – for example, during product development new ideas can be proposed without fear of criticism [ 9 , 10 , 11 ]. It is essential in maintaining safety (construction workers highlighting scenarios that may result in injury) and encouraging improvement [ 12 ]. Within the healthcare setting it promotes the ability to speak up - minimising poor practice and medical error [ 13 ]. There are additional benefits to a psychologically safe environment within the healthcare setting. These include an improvement in wellbeing, reduction in work related stress, an understanding of the importance of learning from failures and an increased engagement in quality improvement [ 14 ]. Psychological safety is an important antecedent to quality improvement as it allows the open sharing of operational failures [ 15 ] and facilitates productive discussion [ 16 ]. This enables the development of solutions that prevent repeated occurrences of errors through the creation of organisational memory, rather than individuals creating a work-around without communicating the issue to the rest of the team (leading to a risk that the error may be repeated) [ 17 , 18 ]. A recent systematic review [ 12 ] of the safety voice literature highlights that in healthcare workers, “employees report a hesitancy for raising safety concerns”. A 2014 review [ 19 ] makes three key conclusions about psychological safety (its “role in enabling performance”, its “relevance for understanding organisational learning” and its presence making individuals “more likely to speak up at work”). This review also highlights areas for future research – including exploring the factors that promote or reduce psychological safety.

Traditionally, healthcare teams have operated under a strict hierarchy [ 20 ]. The presence of a professional hierarchy is well established within the healthcare setting and has been recognised as a barrier to psychological safety - with those in higher positions having increased freedoms to speak and be themselves [ 21 ]. This can prevent individuals in lower positions from speaking across professional boundaries and may subsequently reduce the opportunity for collaborative learning and error reduction [ 22 ]. Whilst much work has been done to flatten this (through dedicated non-technical skills training [ 23 ] and improvement of communication skills [ 24 ]) it is still a contributing factor to medical error [ 25 ]. The importance of psychological safety within the healthcare setting should not be underestimated. Psychological safety is important because it allows those in junior positions within the professional hierarchy (often the individuals most acutely aware of potential safety issues) to speak up. A lack of psychological safety as a result of such a hierarchy can inhibit the communication of problems and creative solutions from those in junior positions who witness them to those higher up within the organisation. This limits the potential for organisational learning [ 17 ]. The presence of psychological safety fosters a culture where healthcare workers will raise safety concerns as they arise because they aren’t concerned about the potential consequences. In such a culture an individual will feel confident that the organisation will listen to and act upon such concerns, irrespective of who within the “hierarchy” raises it.

Medical error rates remain high both within the UK and worldwide [ 26 , 27 ]. In addition, healthcare staff report ongoing dissatisfaction with their working environment– a recurring theme within the annual NHS staff survey [ 28 ]. The delivery of exemplary healthcare requires multiple skill sets – as a result healthcare teams comprise individuals with specific roles and skills. Consequently, a good understanding of each other’s strengths and weaknesses is essential. It is known that a high proportion of medical errors have poor communication as a causative element (a 2015 report on malpractice claims in the US [ 29 ] implicated communication failure in 30% of all malpractice claims and 37% of high severity injury cases). Teams in the healthcare setting are interprofessional, relying upon a shared team identity and a collective understanding of each other’s roles and responsibilities [ 30 ]. The interprofessional nature of these teams can comprise of multiple differing interests and opinions that may create challenges in the absence of good communication [ 14 ]. Effective communication within the interprofessional team is facilitated by team psychological safety, allowing collaborative decision making [ 31 ]. Since high psychological safety is a promotor of good communication within teams [ 32 ] (allowing those with differing aims and working practices to communicate and work together successfully [ 19 ]), the benefit of this review lies in its potential to further understand how psychological safety has been explored within the clinical literature, looking at the importance of psychological safety by evaluating its role in shaping behaviour across multiple studies, the mechanisms through which psychological safety shapes behaviour and identifying future research needs. Namely – what is “normal”, how has it been measured, and whether psychological safety really is important. To address these aims, this study employs thematic analysis, content analysis and evidence synthesis (encompassing all research methodologies – quantitative, mixed methods and qualitative data) - techniques used in similar qualitative syntheses on quality in healthcare [ 33 ].

High levels of psychological safety have clear benefits for patient safety by improving the delivery of clinical care. In addition, it also improves the health of the workforce by promoting job satisfaction & well-being [ 34 , 35 ]. Previous studies into psychological safety tend to focus upon outcomes in terms of patient safety or organisational productivity, without looking at the experiences of the healthcare workers themselves. This study aimed to keep these staff experiences at the centre of the analysis.

There are widely used tools for the assessment of psychological safety [ 4 , 36 ], but it is unclear which ones are preferred and how frequently they are used in studies on healthcare workers.

There were three key objectives within this evidence synthesis:

Objective 1. Synthesise existing literature investigating psychological safety in healthcare workers and use qualitative research methods to explore the presence of psychological safety in this workforce.

Objective 2. Identify the methods used to assess psychological safety in healthcare workers.

Objective 3. Review the literature for evidence of consequences of high or low psychological safety.

The study protocol was developed using the EPOC (Cochrane Effective Practice and Organisation of Care Group) template [ 37 ] and registered on Prospero ( https://www.crd.york.ac.uk/prospero/ Registration Number: CRD42019120104).

The study protocol was initially designed as an evidence synthesis with a focus upon qualitative research methods. The study design was intended (in line with qualitative research methodology) to evolve as an iterative process and following preliminary searches the inclusion criteria were expanded to include all studies exploring psychological safety in healthcare workers. This expansion occurred as it became clear that whilst a qualitative thematic analysis would address the first objective of this study, incorporating quantitative and mixed methods studies would allow a more comprehensive answer to the second two objectives of this synthesis to be developed.

A pre-planned comprehensive search strategy was subsequently developed with the aim of identifying all available studies addressing the topic of psychological safety in healthcare workers, either as a specified aim of the study or as a theme which emerged within the study analysis.

This evidence synthesis used PRISMA as its principle guideline [ 38 ]. As it was anticipated that a significant proportion of the included studies would utilise qualitative or mixed research methodology the Cochrane Qualitative and Implementation Methods Groups Guidance Series [ 38 , 39 , 40 , 41 , 42 , 43 ] were used in addition to structure the project. It is presented in accordance with ENTREQ (Enhancing transparency in the reporting of syntheses of qualitative research), a well cited tool which is included in the EQUATOR (Enhancing the QUality And Transparency Of health Research) network [ 44 ].

The SPIDER Tool [ 45 ] was used to define the plan for conducting this evidence synthesis and as the basis for the electronic search strategy & inclusion criteria.

Healthcare workers (All members of the multidisciplinary team, all levels of seniority).

Phenomenon of interest

Psychological Safety.

All primary studies that used qualitative study designs including ethnography, phenomenology, case studies, grounded theory studies and qualitative process evaluations. Studies that used qualitative methods for data collection (interviews, focus groups, observations and open-ended survey questions) and data analysis (e.g. thematic analysis) were included. Given the prevalence of surveys as a tool used to assess psychological safety, studies which were quantitative in their design were included. Studies were included irrespective of their publication status and language of publication.

An exploration of the presence of psychological safety present in healthcare workers, the methods utilised to assess psychological safety, and the potential consequences of high or low psychological safety.

Research type

Qualitative, Quantitative and Mixed methods.

Data sources

It is acknowledged both within the literature and published guidelines on the synthesis of qualitative studies that the indexing of published papers may be less robust than within quantitative databases. In order to capture as many qualitative studies that addressed the issue of psychological safety in healthcare workers as possible the search terms were kept deliberately broad. Complementary search strategies including citation searching, author searching, and reference list checking were also employed.

Electronic searches

The following electronic databases were searched to identify eligible studies for inclusion. Databases were searched from their date of origin through December 2018 (MEDLINE Ovid, Embase Ovid, PubMed, CINHAIL EBSCO Complete, Cochrane Library, Web of Science, Conference Proceedings Citations Index – Science, Global Health, Ovid, Google Scholar).

Search strategy

S : “Healthcare worker*” OR “Physician” OR “Nurs*” OR “Doctor” OR “Medic*”.

PI : “Psychological Safety OR Interpersonal Risk” OR “Team*” OR “Communication” OR “speak* up”.

D : “questionnaire” OR “Survey” OR “interview” OR “focus group” OR “case stud*” OR “obser*”.

E : “experience*” OR “opinion” OR “outcome*” OR “satisfaction”.

R : “qualitative” OR “mixed method” OR “quantitative”.

Selection of studies

Studies were initially reviewed by title (the deliberately wide search criteria allowed for rejection of many papers at this stage, as despite addressing teamwork or psychological safety they were clearly not related to the topic of interest – namely papers that did not address psychological safety within the healthcare setting.). Abstracts of potential papers for inclusion were reviewed for evidence that they addressed the topic of psychological safety, safety within healthcare, speaking up, or teamwork. This review and study selection were performed by one researcher in the team (KG).

Full text of papers deemed suitable for inclusion were retrieved and reviewed in depth. The methods with which psychological safety was assessed and the robustness and validity of this assessment was explored (using both the CASP Qualitative Checklist tool [ 46 ] and published guidance on the assessment of survey quality [ 47 ]). This was performed primarily by one researcher (KG), with discussion regarding suitability of papers for inclusion and imposed criteria for selection within the wider research team.

Data extraction

The following data were extracted from the included papers and assembled within an Excel table (Table  1 ) (Microsoft, Redmond, Washington, USA) to facilitate cross comparison and analysis.

Assessment of the methodological limitations in included studies

Each qualitative study was reviewed for methodological limitations using the CASP Qualitative checklist tool [ 46 ]. The GRADE-CERQual (Confidence in the Evidence from Reviews of Qualitative Research) approach [ 40 ] was implemented to summarise our confidence in each finding. CERQual assesses confidence in the evidence based upon four key components: methodological limitations, coherence of the review finding, adequacy of the data contributing to a review finding and relevance of the included studies to the review question. It was anticipated a high proportion of quantitative or mixed methods studies would utilise surveys as a research strategy. The assessment of possible methodological limitations of these surveys was done in line with published guidance regarding survey quality [ 47 , 48 , 49 ].

Synthesis methodology

Objective 1.

Exploration of psychological safety within each study’s participant group and synthesis of subsequent extracted data. The thematic analysis was primarily undertaken by one researcher (KG), with ongoing discussion with the wider research team at each stage.

This thematic analysis was completed in a three-step approach:

Familiarisation with the data and extraction of data related to psychological safety. Data included key concepts as derived by study authors and verbatim participant data from published manuscripts.

Coding of data related to a participant’s experiences of psychological safety and development of descriptive themes. To address the study objective, data that reflected a study participant’s psychological safety were coded into “evidence of high psychological safety” or “evidence of low psychological safety”. All extracted data were analysed to identify commonalities and report patterns in the data associated with the psychological safety within each study participant group (whether low, moderate or high). These patterns were developed into a hierarchical code structure.

Generation of analytical themes beyond the content of the original studies

Objective 2

Identification of methods used to assess psychological safety.

Data regarding the tools used to assess psychological safety were extracted from the methods section of each included study. These were grouped according to whether they were quantitative, qualitative or used mixed methodology. Within this, details regarding the exact method of data collection and analysis were extracted and coded.

Objective 3

Identification of any consequences of low or high psychological safety.

A content analysis approach was employed to identify any patterns in conclusions made by each study regarding the observed presence of psychological safety and possible outcomes. Data presented in results and discussion of each included study were reviewed and any data suggesting an association between psychological safety and a linked outcome were extracted and coded. The data were reported as a frequency of each possible consequence and the level of psychological safety it was related to (low or high). It was also recorded whether the conclusions regarding the consequence of psychological safety as identified in each study were the opinion / inference of the study authors or derived from statistical study data.

The datasets supporting the conclusions of this article are included within the article and its additional files.

Reflexivity

During the data synthesis the authors were aware of their own positions and reflected on how these may influence the study design, search strategy, inclusion decisions, data extraction, analysis, synthesis and interpretation of the findings.

For reflexivity, the positions of the authors are as follows: KEG is a PhD student with a clinical background in anaesthesia and critical care, TR is an academic in organisational and safety culture, EJM is a former NHS manager and is now an academic in organisational studies and SJB is a clinical academic and consultant in intensive care. All have prior experience with the conduct and analysis of qualitative studies in the healthcare environment.

At the outset of this review, all authors believed that individuals with high psychological safety would have higher job satisfaction and be less affected by stress within the clinical environment. The authors also believed that high levels of psychological safety would confer better teamworking and ultimately better outcomes for both the patient and the organisation. The team maintained a reflexive position throughout all stages of the review to minimise the risk that these presumptions would skew the analysis and subsequent interpretation of findings.

As anticipated, by intentionally keeping the search strategy broad the number of papers retrieved by the initial database search was extensive with a total of 28,688 titles identified. This meant a huge number of studies (27,820) could be excluded at the title review stage as they were clearly unrelated to the research objectives. Abstracts of 868 papers addressing themes of teamwork, error reporting or psychological safety were reviewed and 173 were taken forward for full text review. Fourteen duplicates were removed, and 105 articles excluded following full text review. During data extraction a further 6 papers were excluded (these were either from the same research group and used data previously analysed in another study already included or did not provide sufficient data within the results section to use within a thematic analysis). Sixty-two papers were deemed eligible. The Prisma flow diagram for this process is illustrated in Fig.  1 .

figure 1

A PRISMA flow diagram demonstrating the search results and the process of screening and selection of studies for inclusion

Study characteristics

Study characteristics for each of the 62 included studies can be seen in Additional File  1 . Included studies originated from 19 countries, encompassing a total of 32,677 participants. Sixty were hospital-based studies, with 2 incorporating both primary & secondary care sites. Forty-four papers assessed psychological safety as one of their primary outcomes, 3 listed it as a secondary objective and 15 papers discussed the presence of psychological safety as a theme which emerged in the analysis of qualitative data.

The aims and objectives of all papers were coded and collapsed into themes. The most frequently studied aim relating to psychological safety was “assessing the perceived motivations and barriers to speaking up”. The coding categories for the aims of each study are summarised in Table  2 .

Research objectives

Experiences of psychological safety.

Each included study was reviewed with a focus upon qualitative data presented within the results (most frequently as interview/focus group transcript excerpts, or open-ended survey responses), and on the conclusions presented within discussion sections.

Data corresponding to experiences of psychological safety or impressions regarding a healthcare worker’s psychological safety were extracted and coded. These codes were organised into a framework including data corresponding to psychological safety, the factors which influenced its presence and associated themes such as error, teamwork and safety.

Data from each study were analysed to gain an overall impression of the psychological safety in each study’s participant group (whether that be “high”, “moderate” or “low”). Sixteen studies demonstrated predominantly low psychological safety (8 qualitative, 5 quantitative and 3 mixed methods). Examples of this included demonstrating nurses not challenging doctors’ practice [ 82 ] and that both fear of repercussion and unclear expectations limited an individual’s psychological safety [ 58 ]. Only 6 studies (2 qualitative and 4 quantitative) reported a predominance of high psychological safety within their study participants, highlighting that the importance of preventing harm to patients empowered individuals and improved psychological safety [ 92 ]. Seven studies demonstrated that they had observed an improvement in psychological safety after an intervention such as interpersonal team training [ 94 ]. Fifteen studies did not report homogenous finding for the psychological safety of their participants, with both high and low levels of psychological safety identified within their participant group. The assessment of psychological safety for each study and supporting themes are presented in Additional File  2 .

Qualitative data presented within each study in the form of verbatim quotes that related to an individual’s study participants psychological safety were identified and coded into two groups – “high” and “low”.

Examples of low psychological safety highlighted the importance of hierarchy and supportive seniors:

“a lot of people are still in awe of physicians and will not question physicians” [ 88 ].
“there is nowhere to turn. They [management] just laugh at you or look through you” [ 83 ]

Data indicating a higher level of psychological safety demonstrated the importance of supportive leadership and shared goals within the team:

“everyone’s view is listened to, even if it’s in the minority” [ 81 ].
“we’d done a timeout, we knew each other’s names, we were all focused on the same thing” [ 92 ]

Further examples of data coded into each category are presented in Additional File  3 .

The heterogeneity of the data around individual healthcare workers psychological safety across all 62 papers was such that it was not possible to draw an overall or generalisable conclusion about the psychological safety of healthcare workers as a collective. Whilst many of the included studies used quantitative methodology, the wide range of data collection tools and scales prevented an overall compilation of this data, and again assessing the overall presence of psychological safety in this subgroup was not feasible. The data extracted during this thematic analysis were used in the generation of analytical themes, as reported later in this paper.

Methods used to assess psychological safety

The 62 included studies utilised a number of different research methodologies, as outlined in Table  3 .

Within studies using quantitative surveys, 9 used existing survey formats - 3 utilised Edmonson’s safety tool [ 4 ], 3 used the safety attitudes questionnaire (SAQ) [ 111 ] and 3 used SUPS-Q (Speaking Up about Patient Safety – Questionnaire) [ 54 ]. There was an approximate 50:50 split between studies that used qualitative and quantitative methodology with a small proportion (6/62) using mixed methodology. A wide range of qualitative techniques were employed, the most frequent being semi-structured interviews allowing participants to explore their own previous experiences. A review of the available topic guides for studies that used interviews / focus groups showed concordance in the style of questions and topics addressed – including ease in voicing concerns and feelings around speaking up.

It became apparent that there were 4 different approaches to evaluating psychological safety:

Participants asked to reflect on their past experiences of psychological safety ( n  = 41)

Participants asked to predict how they feel they might behave in hypothetical clinical scenarios ( n  = 8)

Evaluation of the change in psychological safety after an intervention (teamworking exercise or structured ward rounds) ( n  = 9)

Participants observed during simulated scenarios as a technique to explore their psychological safety. ( n  = 4)

Evidence of consequences of high or low psychological safety

Eighteen of the included studies either investigated outcomes associated with psychological safety, or inferred consequences as a result of the climate of psychological safety identified.

Within this subgroup were 9 quantitative studies using surveys, 8 qualitative studies (6 utilised interviews and 2 used focus group) and 1 study using simulation and subsequent quantitative scoring of observed interactions.

Nine studies found a statistically significant relationship between the presence of psychological safety and a defined outcome measure – with high psychological safety positively related to creative performance and knowledge sharing [ 57 ], technical team performance [ 101 ], improving continuous quality improvement [ 70 ] and patient centred care [ 70 ]. Psychological safety was positively associated with learning from failure and performance [ 81 ]. Low psychological safety was negatively correlated with speaking up and withholding voice [ 54 ]. The remaining studies in this subgroup used data reported by participants about their experience in the clinical environment to infer correlations and associations between psychological safety and possible consequences. The most commonly inferred association by study authors was that low psychological safety had a negative impact on patient risk of harm, identified in 10 studies. Data extracted during the content analysis can be viewed in Additional File  4 .

Analytical themes

The thematic analysis led to the development of two themes which go beyond the content of the original studies. These themes were the presence of facilitators and barriers to psychological safety, and the influence of situational context on the psychological safety of healthcare workers.

Data extraction and coding of descriptive items captured within the thematic analysis provided detailed information regarding the facilitators and barriers to psychological safety within the workplace, as perceived by each individual participant. Discussion and analysis within the research team allowed this data to be organised into higher order categories. These categories included culture, workload, infrastructure, teamwork and motivation. These categories and data within each category relating to facilitators and barriers of psychological safety are demonstrated in Additional File  5 .

These categories were organised into a framework outlining the level within the workplace at which they were significant – individual, team or organisational (it was possible for a factor to be relevant at more than one level). This concept is illustrated in Fig.  2 .

figure 2

Diagram illustrating the barriers and facilitators to psychological safety and where they were significant within the workplace

The second analytical theme that emerged was surrounding the influence of situational context (as associated with every clinical scenario) on psychological safety. The influence of situational context (defined as “variables that influence or could influence the ‘independent’ and dependent variable directly under study” [ 112 ]) on psychological safety emerged as a recurrent theme within the thematic analysis. The analysis evolved into the development of a framework and subsequently a model outlining the dynamics associated with situational context and their potential impact on psychological safety and outcomes within the healthcare environment.

This thematic analysis had 3 stages. First the data were re-reviewed for evidence relating to situational context as defined. Subsequently the relationship of this data to the presence of psychological safety was explored. Thirdly we analysed how situational context might influence the healthcare worker or clinical situation through its effect on psychological safety.

Data within our model were again organised within a framework identifying the level within the workplace that each aspect of situational context was relevant (Fig.  3 ). The figure highlights some of the contextual factors at each level that are not frequently considered in other models of psychological safety, and their particular relevance to a healthcare setting.

figure 3

A model illustrating the influence of situational context on psychological safety within the healthcare environment

Quality appraisal

Twenty-eight of the included studies used a purposive sampling technique. This is a well utilised sampling technique within qualitative research and provides a representation of the sample population studied (rather than being generalisable across a wider population). It is possible that within each study population there are individuals who were not represented. It is also impossible to generalise the findings of one paper to the entire population of healthcare workers.

However, sampling for proportionality was not the main concern within these studies, therefore a potential bias in recruitment is unlikely to be detrimental to the overall conclusions of each study and this evidence synthesis.

Studies that were wholly qualitative in nature were less susceptible to selection bias than those who applied a stratified sampling technique (for example those who distributed surveys to entire departments and relied on individuals motivated to participate), given the fact they recruited until thematic saturation was achieved.

Given the desired outcomes of each study, and of this evidence synthesis, no study was rejected due to risk of bias or methodological limitations. Qualitative studies were not excluded on the basis of our assessment of their methodological limitations, but this information was used in the assessment of our confidence in the synthesis findings.

This evidence synthesis collates a broad range of worldwide data to provide information regarding psychological safety in healthcare workers, as well as being the largest collation of papers exploring the topic of psychological safety to date. This study found that there was substantial variation in the psychological safety reported by healthcare workers across all studies, and evidence that there is an ongoing need to focus upon its improvement. We highlight a huge variety in the methods used to evaluate psychological safety within the literature and demonstrate that there is evidence that the presence of psychological safety has an impact on the clinical environment, both for the healthcare workers themselves and their patients. The thematic analysis undertaken to address our original research objectives yielded two themes which go beyond the content of the included studies and provide a novel contribution to the existing literature.

Individuals possessing high levels of psychological safety are crucial to effective and safe healthcare delivery, and also in the promotion of organisational learning. Such individuals contribute by discussing risk and adapting to avoid error; consequently, the organisation can find new pathways and processes to facilitate future positive outcomes. This evidence synthesis corroborates existing themes (such as the importance of leader inclusiveness [ 19 ]) and builds on models created by previous reviews [ 19 , 113 , 114 , 115 ] about the relationships contributing to psychological safety at the individual, team and organisational level.

The data synthesised in this study is reassuring for healthcare leaders – we demonstrate that psychological safety is consistently shown to be present (often to high levels) within the populations of healthcare workers studied. However, the analysis demonstrated that there is consistently a number of individuals who report feelings and behaviours consistent with low psychological safety.

There was little consistency in the methods used to assess psychological safety. A large number of studies incorporated the use of quantitative surveys, but these were often developed by the authors themselves, as opposed to drawing on tools already available. As such there is scope to validate an existing assessment tool for psychological safety in the population of healthcare workers.

Several studies indicated that psychological safety had a significant benefit on the working environment, particularly when applied to teamwork, team creativity and quality improvement. Whilst no studies provided statistically significant evidence of correlations between low psychological safety and adverse outcomes (impossible in the case of the qualitative studies) there was a strong feeling that this had a negative impact on patient safety. This was predictable based upon prior research; but it was also interesting to observe some of the potential consequences for the individual worker – low self-esteem, increased intention to leave the profession and risk of moral distress. No studies were designed with this outcome in mind, and as such these are opinion at best, but the signal that low psychological safety is detrimental both to the service delivered and the individual healthcare worker is present and warrants further investigation.

A very clear theme regarding the facilitators and barriers to psychological safety experienced by individual healthcare workers worldwide emerged during this thematic analysis. Many of these barriers and facilitators are evidenced in existing literature – such as an individual’s confidence, supportive senior staff and management, feedback from previous episodes of speaking up and the presence of a strong hierarchy [ 21 ]. Barriers to speaking up less commonly acknowledged within the existing literature included the influence of an individual’s current workload, the reason itself for speaking up (patient safety was a big motivator, however if related to unprofessional behaviour individuals appeared less likely to speak up) and fear of conflict in front of patients. It is not surprising that effective reporting channels, all members of the team feeling enabled and high occupational self-efficacy were key in promoting psychological safety. These are examples of both organisational factors (the improvement of reporting channels and feedback to individuals), and individual factors – improving confidence and knowledge base.

We contribute to the existing literature by providing a detailed explanation about how situational context can influence psychological safety within the healthcare sector. We illustrate how the factors that contribute to this context are present at all levels – individual, team and organisation. This context can be precarious and will change depending upon the factors associated with each clinical event. For example, at the organisational level, within the category of infrastructure, we observed that the setting for speaking up had an impact on an individual’s psychological safety. An individual may feel confident to speak up in the context of a private setting but be constrained by the context of a public venue.

Organisational culture has an influence on situational context and the consequential perception of a psychologically safe environment. Changing the culture of an organisation, envisaged with a view to improving psychological safety, can be challenging due to the presence of multiple stakeholders and the complexities associated with the healthcare setting [ 14 ]. Team leaders have a crucial role in mitigating these challenges and promoting a psychologically safe environment through leadership behaviours such as inclusiveness and being change oriented [ 16 ]. Our model demonstrating the influence of situational context provides a framework for team leaders wanting to implement change that allows the understanding and subsequent management of the dynamics associated with situational context within the healthcare environment. The model also highlights how context can impact the perception of psychological safety by an individual, with certain contextual factors promoting either high or low psychological safety. In practice this understanding of context is related to a leader’s situational awareness [ 116 ]. If leaders understand where scenarios leading to low psychological safety may arise, they can use this framework to perceive potential issues within the workplace, identify them as relevant and project the potential impact. Through this, leaders may be able to modify the situational context and subsequently improve psychological safety.

There are limitations within this evidence synthesis. Whilst we intentionally kept the search strategy broad there is still the possibility that some qualitative papers did not appear within our search as a consequence of unreliable indexing. However, this is unlikely to have had a significant impact on the findings of this thematic analysis, as the large number of papers included allowed a point of thematic saturation to be achieved, in line with qualitative methodology [ 117 , 118 ].

We have addressed the possibility of selection bias within individual papers, or that entire populations may not be accurately represented (particularly in relation to quantitative surveys with lower response rates). Given the aim of this study was to explore psychological safety, the themes and concepts drawn from the data are still extremely useful, even if some surveys had the potential for a negative selection bias (i.e., only those who had conflict / dissatisfaction to report volunteered to participate). It is also possible that centres participating in studies investigating teamwork & safety were more aligned to these ideals in the first place, thereby introducing the possibly of some sampling bias.

Another consideration is the approach used to assess psychological safety. Forty-one papers required individuals to reflect on their previous behaviour – which assumes that their recollection is reliable. This also raises the question – is asking people to predict how they might behave an accurate reflection of real-life behaviour, given that people are unlikely to volunteer that they would behave in a way that may be detrimental to patient safety.

Several opportunities for future research are highlighted in this evidence synthesis. Firstly, there is scope to validate a tool specifically for the assessment of psychological safety within healthcare workers.

Many of the studies looking at psychological safety within the population of healthcare workers focus on how it relates to voicing concerns and the subsequent benefits for patient safety. This is one manifestation of a psychologically safe environment; however, it is important to explore other expressions of psychological safety such as innovation and organisational commitment [ 5 ], and to explore for links to staff satisfaction and career longevity.

This study is limited to exploring the presence of psychological safety within study participants and does not look at what may be contributing to different levels in different countries. It would be interesting to further explore how cultural factors may influence psychological safety, particularly within the context of a multi-cultural workplace environment.

At best this evidence synthesis highlights areas where situational context may influence an individual’s psychological safety and the variables which may be affected by this (such as patient safety). Further research is required, perhaps in the form of an ethnographic study to observe the impact of situational context on psychological safety and further analyse the determinant role of situational context on psychological safety.

This evidence synthesis provides positive data regarding the presence of psychological safety within healthcare workers, whilst illuminating areas for improvement. We add more detail to the current literature regarding the facilitators and barriers of psychological safety and highlight how situational context can influence the creation of a psychologically safe environment.

There are many factors which can oppose the presence of psychological safety – including the influence of the team leader, personalities of individual team workers, the responsibility associated with the decisions required of the team and the speed at which decisions need to be made. These are likely to be consistent across most healthcare environments, and as such the findings of this evidence synthesis are transferrable across different clinical environments and populations of healthcare workers.

Many of the factors that contribute to psychological safety are not malleable or easy to change (especially within the constraints of a resource poor environment). It is also likely to be the case that some factors promoting psychological safety will be unique to the team itself, and the individual personalities and stresses that are found within that particular environment [ 119 , 120 ]. Through improved understanding of the contributing factors to psychological safety and the areas in which situational context is especially important it is possible that some modifiable factors will be identified. This information can be used by team leaders and management to promote psychological safety within their clinical environment.

Availability of data and materials

The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.

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Acknowledgements

KG received a restricted educational grant from BUPA Cromwell Hospital. The funders played no role in the design of the study, data collection, analysis, interpretation or writing the manuscript. data collection, analysis, interpretation or writing the manuscript. Infrastructure support for this research was provided by the National Institute for Health Research Imperial Biomedical Research Centre.

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Additional file 1:.

Summary of Study Characteristics Table.

Additional file 2:

Results of Individual Studies.

Additional file 3:

Supporting Quotes: Experiences of Psychological Safety.

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Possible consequences of high or low psychological safety.

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Facilitators and Barriers to Psychological Safety.

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Grailey, K.E., Murray, E., Reader, T. et al. The presence and potential impact of psychological safety in the healthcare setting: an evidence synthesis. BMC Health Serv Res 21 , 773 (2021). https://doi.org/10.1186/s12913-021-06740-6

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Case Studies: Office Safety Success Stories

Ensuring a safe and secure workplace is of paramount importance for any organization. Office safety not only protects employees from accidents and injuries but also fosters a culture of well-being and productivity. In this article, we will explore two case studies that highlight successful office safety initiatives and how they have enhanced safety measures and cultivated a culture of workplace safety.

Case Study: Enhancing Office Safety Measures

In this case study, XYZ Corporation, a leading multinational company, took proactive measures to enhance office safety. They identified potential hazards through rigorous inspections and risk assessments. By conducting regular audits, they were able to identify areas that required improvement and promptly took necessary actions to address them. For instance, they installed safety signage, implemented ergonomic workstations, and organized training sessions on proper lifting techniques. Additionally, XYZ Corporation introduced a safety reporting system that encouraged employees to report any safety concerns or near misses, leading to prompt corrective actions.

Another key aspect of XYZ Corporation’s success in enhancing office safety measures was the implementation of a robust emergency response plan. They conducted thorough drills to ensure that all employees were familiar with evacuation procedures, assembly points, and emergency contacts. By involving employees in the planning process and assigning specific roles and responsibilities during emergencies, XYZ Corporation created a sense of ownership and preparedness amongst its workforce. This not only improved response times but also boosted employee confidence in handling critical situations.

Case Study: Achieving a Culture of Workplace Safety

In this case study, ABC Enterprises, a mid-sized company, focused on cultivating a culture of workplace safety by prioritizing employee engagement and empowerment. ABC Enterprises recognized that office safety is not just a set of rules and regulations, but a shared responsibility of every individual in the organization. To achieve this, they implemented a safety committee comprising representatives from different departments to regularly assess and review safety protocols.

Moreover, ABC Enterprises encouraged open communication channels, allowing employees to provide feedback, suggestions, and report potential hazards without fear of reprisals. They also organized regular safety training programs to educate employees about the importance of following safety protocols. By involving employees in decision-making processes and recognizing their contributions to office safety, ABC Enterprises successfully fostered a culture where employees felt safe, valued, and actively participated in maintaining a safe workplace.

The case studies of XYZ Corporation and ABC Enterprises demonstrate that enhancing office safety measures and achieving a culture of workplace safety require proactive and systematic approaches. By identifying potential hazards, implementing preventive measures, and engaging employees in safety initiatives, organizations can significantly reduce workplace accidents, injuries, and near misses. Moreover, a culture of workplace safety not only protects employees but also enhances productivity, morale, and overall well-being. Prioritizing office safety should be an integral part of every organization’s strategy to create a secure and thriving work environment.

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Psychological safety and the critical role of leadership development

When employees feel comfortable asking for help, sharing suggestions informally, or challenging the status quo without fear of negative social consequences, organizations are more likely to innovate quickly , unlock the benefits of diversity , and adapt well to change —all capabilities that have only grown in importance during the COVID-19 crisis. 1 Jonathan Emmett, Gunnar Schrah, Matt Schrimper, and Alexandra Wood, “ COVID-19 and the employee experience: How leaders can seize the moment ,” June 2020, McKinsey.com; Tera Allas, David Chinn, Pal Erik Sjatil, and Whitney Zimmerman, “ Well-being in Europe: Addressing the high cost of COVID-19 on life satisfaction ,” June 2020, McKinsey.com. Yet a McKinsey Global Survey conducted during the pandemic confirms that only a handful of business leaders often demonstrate the positive behaviors that can instill this climate, termed psychological safety , in their workforce. 2 The online survey was in the field from May 14–29, 2020, and garnered responses from 1,574 participants representing the full range of regions, industries, company sizes, functional specialties, and tenures. Of those respondents, we analyzed the results of 1,223 participants who said they were a member of a team that they did not lead, where a team is defined as two or more people who work together to achieve a common goal. CEOs were included in the findings if they said that a) their organization had a board of directors and b) they were not the board’s chair, so that they could think of their board when asked questions about their team.

As considerable prior research shows, psychological safety is a precursor to adaptive, innovative performance—which is needed in today’s rapidly changing environment—at the individual, team, and organization levels. 3 Amy C. Edmondson, The Fearless Organization: Creating Psychological Safety in the Workplace for Learning, Innovation, and Growth, first edition, Hoboken, NJ: John Wiley & Sons, November 2018; Shirley A. Ashauer and Therese Macan, “How can leaders foster team learning? Effects of leader-assigned mastery and performance goals and psychological safety,” Journal of Psychology, November–December 2013, Volume 147, Number 6, pp. 541–61, tandfonline.com; Anne Boon et al., “Team learning beliefs and behaviours in response teams,” European Journal of Training and Development, May 2013, Volume 37, Number 4, pp. 357–79, emerald.com; Daphna Brueller and Abraham Carmeli, “Linking capacities of high-quality relationships to team learning and performance in service organizations,” Human Resource Management, July–August 2011, Volume 50, Number 4, pp. 455–77, wileyonlinelibrary.com; M. Lance Frazier et al., “Psychological safety: A meta-analytic review and extension,” Personnel Psychology, February 2017, Volume 70, Number 1, pp. 113–65, onlinelibrary.wiley.com; Nikos Bozionelos and Konstantinos C. Kostopoulos, “Team exploratory and exploitative learning: Psychological safety, task conflict, and team performance,” Group & Organization Management, June 2011, Volume 36, Number 3, pp. 385–415, journals.sagepub.com; Rosario Ortega et al., “The emotional impact of bullying and cyberbullying on victims: A European cross-national study,” Aggressive Behavior, September–October 2012, Volume 38, Issue 5, pp. 342–56, onlinelibrary.wiley.com; Corinne Post, “Deep-level team composition and innovation: The mediating roles of psychological safety and cooperative learning,” Group & Organizational Management, October 2012, Volume 37, Number 5, pp. 555–88, journals.sagepub.com; Charles Duhigg, “What Google learned from its quest to build the perfect team,” New York Times, February 25, 2016, nytimes.com. Amy Edmondson’s 1999 research previously found—and our survey findings confirm—that higher psychological safety predicts a higher degree of boundary-spanning behavior, which is accessing and coordinating with those outside of an individual’s team to accomplish goals. For example, successfully creating a “ network of teams ”—an agile organizational structure that empowers teams to tackle problems quickly by operating outside of bureaucratic or siloed structures—requires a strong degree of psychological safety.

Fortunately, our newest research suggests how organizations can foster psychological safety. Doing so depends on leaders at all levels learning and demonstrating specific leadership behaviors that help their employees thrive. Investing in and scaling up leadership-development programs  can equip leaders to embody these behaviors and consequently cultivate psychological safety across the organization.

A recipe for leadership that promotes psychological safety

Leaders can build psychological safety by creating the right climate, mindsets, and behaviors within their teams. In our experience, those who do this best act as catalysts, empowering and enabling other leaders on the team—even those with no formal authority—to help cultivate psychological safety by role modeling and reinforcing the behaviors they expect from the rest of the team.

Our research finds that a positive team climate—in which team members value one another’s contributions, care about one another’s well-being, and have input into how the team carries out its work—is the most important driver of a team’s psychological safety. 4 Past research by Frazier et al. (2017) found three categories to be the main drivers of psychological safety: positive leader relations, work-design characteristics, and a positive team climate. We conducted multiple regression with relative-importance analysis to understand which category matters most, and our results show that a positive team climate has a significantly stronger direct effect on psychological safety than the other two. Based on these results, we tested a structural-equation model (SEM) in which the frequency with which team leaders displayed four leadership behaviors predicted psychological safety both directly and indirectly via positive team climate. Exploratory analyses were conducted to determine whether the effect of the leadership behaviors affected psychological safety at different levels of team climate. By setting the tone for the team climate through their own actions, team leaders have the strongest influence on a team’s psychological safety. Moreover, creating a positive team climate can pay additional dividends during a time of disruption. Our research finds that a positive team climate has a stronger effect on psychological safety in teams that experienced a greater degree of change in working remotely than in those that experienced less change during the COVID-19 pandemic. Yet just 43 percent of all respondents report a positive climate within their team.

Positive team climate is the most important driver of psychological safety and most likely to occur when leaders demonstrate supportive, consultative behaviors, then begin to challenge their teams.

During the pandemic, we have seen an accelerated shift away from the traditional command-and-control leadership style known as authoritative leadership, one of the four well-established styles of leadership behavior we examined to understand which ones encourage a positive team climate and psychological safety . The survey finds that team leaders’ authoritative-leadership behaviors are detrimental to psychological safety, while consultative- and supportive-leadership behaviors promote psychological safety.

The results also suggest that leaders can further enhance psychological safety by ensuring a positive team climate (Exhibit 1). Both consultative and supportive leadership help create a positive team climate, though to varying degrees and through different types of behaviors.

With consultative leadership, which has a direct and indirect effect on psychological safety, leaders consult their team members, solicit input, and consider the team’s views on issues that affect them. 5 The standardized regression coefficient between consultative leadership and psychological safety was 0.54. The survey measured consultative-leadership behaviors by asking respondents how frequently their team leaders demonstrate the following behaviors: ask the opinions of others before making important decisions, give team members the autonomy to make their own decisions, and try to achieve team consensus on decisions. Supportive leadership has an indirect but still significant effect on psychological safety by helping to create a positive team climate; it involves leaders demonstrating concern and support for team members not only as employees but also as individuals. 6 The survey measured supportive leadership behaviors by asking respondents how frequently their team leaders demonstrate the following behaviors: create a sense of teamwork and mutual support within the team, and demonstrate concern for the welfare of team members. These behaviors also can encourage team members to support one another.

Another set of leadership behaviors can sometimes strengthen psychological safety—but only when a positive team climate is in place. This set of behaviors, known as challenging leadership, encourages employees to do more than they initially think they can. A challenging leader asks team members to reexamine assumptions about their work and how it can be performed in order to exceed expectations and fulfill their potential. Challenging leadership has previously been linked with employees expressing creativity, feeling empowered to make work-related changes, and seeking to learn and improve. 7 Giles Hirst, Helen Shipton, and Qin Zhou, “Context matters: Combined influence of participation and intellectual stimulation on the promotion focus–employee creative relationship,” Journal of Organizational Behavior, October 2012, Volume 33, Number 7, pp. 894–909, onlinelibrary.wiley.com; Le Cong Thuan, “Motivating follower creativity by offering intellectual stimulation,” International Journal of Organizational Analysis, December 2019, Volume 28, Number 4, pp. 817–29, emerald.com; Jie Li et al., “Not all transformational leadership behaviors are equal: The impact of followers’ identification with leader and modernity on taking charge,” Journal of Leadership and Organizational Studies, August 2017, Volume 24, Number 3, pp. 318–34, journals.sagepub.com; Susana Llorens-Gumbau, Marisa Salanova Soria, and Israel Sánchez-Cardona, “Leadership intellectual stimulation and team learning: The mediating role of team positive affect,” Universitas Psychologica, March 2018, Volume 17, Number 1, pp. 1–16, revistas.javeriana.edu.co. However, the survey findings show that the highest likelihood of psychological safety occurs when a team leader first creates a positive team climate, through frequent supportive and consultative actions, and then challenges their team; without a foundation of positive climate, challenging behaviors have no significant effect. And employees’ experiences look very different depending on how their leaders behave, according to Amy Edmondson, the Novartis Professor of Leadership and Management at Harvard Business School (interactive).

What’s more, the survey results show that a climate conducive to psychological safety starts at the very top of an organization. We sought to understand the effects of senior-leader behavior on employees’ sense of safety and found that senior leaders can help create a culture of inclusiveness that promotes positive leadership behaviors throughout an organization by role-modeling these behaviors themselves. Team leaders are more likely to exhibit supportive, consultative, and challenging leadership if senior leaders demonstrate inclusiveness—for example, by seeking out opinions that might differ from their own and by treating others with respect.

The importance of developing leaders at all levels

Our findings show that investing in leadership development across an organization—for all leadership positions—is an effective method for cultivating the combination of leadership behaviors that enhance psychological safety. Employees who report that their organizations invest substantially in leadership development are more likely to also report that their team leaders frequently demonstrate consultative, supportive, and challenging leadership behaviors. They also are 64 percent more likely to rate senior leaders as more inclusive (Exhibit 2). 8 We measured investing in leadership development by asking about agreement with the following statements: “my organization places a great deal of importance on developing its leaders,” and “my organization devotes significant resources to developing its leaders.” However, the results suggest that the effectiveness of these programs varies depending upon the skills they address.

Reorient the skills developed in leadership programs

Organizations often attempt to cover many topics in their leadership-development programs . But our findings suggest that focusing on a handful of specific skills and behaviors in these learning programs can improve the likelihood of positive leadership behaviors that foster psychological safety and, ultimately, of strong team performance. Some of the most commonly taught skills at respondents’ organizations—such as open-dialogue skills, which allow leaders to explore disagreements and talk through tension in a team—are among the ones most associated with positive leadership behaviors. However, several relatively untapped skill areas also yield beneficial results (Exhibit 3).

Two of the less-commonly addressed skills in formal programs are predictive of positive leadership. Training in sponsorship—that is, enabling others’ success ahead of one’s own—supports both consultative- and challenging-leadership behaviors, yet just 26 percent of respondents say their organizations include the skill in development programs. And development of situational humility, which 36 percent of respondents say their organizations address, teaches leaders how to develop a personal-growth mindset and curiosity. Addressing this skill is predictive of leaders displaying consultative behaviors.

Development at the top is equally important

According to the data, fostering psychological safety at scale begins with companies’ most senior leaders developing and embodying the leadership behaviors they want to see across the organization. Many of the same skills that promote positive team-leader behaviors can also be developed among senior leaders to promote inclusiveness. For example, open-dialogue skills and development of social relationships within teams are also important skill sets for senior leaders.

In addition, several skills are more important at the very top of the organization. Situational and cultural awareness, or understanding how beliefs can be developed based on selective observations and the norms in different cultures, are both linked with senior leaders’ inclusiveness.

Looking ahead

Given the quickening pace of change and disruption and the need for creative, adaptive responses from teams at every level, psychological safety is more important than ever. The organizations that develop the leadership skills and positive work environment that help create psychological safety can reap many benefits, from improved innovation, experimentation, and agility to better overall organizational health and performance. 9 We define organizational health as an organization’s ability to align on a clear vision, strategy, and culture; to execute with excellence; and to renew the organization’s focus over time by responding to market trends.

As clear as this call to action may be, “How do we develop psychological safety?” and, more specifically, “Where do we start?” remain the most common questions we are asked. These survey findings show that there is no time to waste in creating and investing in leadership development at scale to help enhance psychological safety. Organizations can start doing so in the following ways:

  • Go beyond one-off training programs and deploy an at-scale system of leadership development. Human behaviors aren’t easily shifted overnight. Yet too often we see companies try to do so by using targeted training programs alone. Shifting leadership behaviors within a complex system at the individual, team, and enterprise levels begins with defining a clear strategy aligned to the organization’s overall aspiration and a comprehensive set of capabilities that are required to achieve it. It’s critical to develop a taxonomy of skills (having an open dialogue, for example) that not only supports the realization of the organization’s overall identity but also fosters learning and growth and applies directly to people’s day-to-day work. Practically speaking, while the delivery of learning may be sequenced as a series of trainings—and rapidly codified and scaled for all leaders across a cohort or function of the organization—those trainings will be even more effective when combined with other building blocks of a broader learning system, such as behavioral reinforcements. While learning experiences look much different now than before the COVID-19 pandemic , digital learning provides large companies with more opportunities to break down silos and create new connections across an organization through learning.
  • Invest in leadership-development experiences that are emotional, sensory, and create aha moments. Learning experiences that are immersive and engaging are remembered more clearly and for a longer time. Yet a common pitfall of learning programs is an outsize focus on the content—even though it is usually not a lack of knowledge that holds leaders back from realizing their full potential. Therefore, it’s critical that learning programs prompt leaders to engage with and shift their underlying beliefs, assumptions, and emotions to bring about lasting mindset changes. This requires a learning environment that is both conducive to the often vulnerable process of learning and also expertly designed. Companies can begin with facilitated experiences that push learners toward personal introspection through targeted reflection questions and small, intimate breakout conversations. These environments can help leaders achieve increased self-awareness, spark the desire for further growth, and, with the help of reflection and feedback, drive collective growth and performance.
  • Build mechanisms to make development a part of leaders’ day-to-day work. Formal learning and skill development serve as springboards in the context of real work; the most successful learning journeys account for the rich learning that happens in day-to-day work and interactions. The use of learning nudges (that is, daily, targeted reminders for individuals) can help learners overcome obstacles and move from retention to application of their knowledge. In parallel, the organization’s most senior leaders need to be the first adopters of putting real work at the core of their development, which requires senior leaders to role model—publicly—their own processes of learning. In this context, the concept of role models has evolved; rather than role models serving as examples of the finished product, they become examples of the work in progress, high on self-belief but low on perfect answers. These examples become strong signals for leaders across the organization that it is safe to be practicing, failing, and developing on the job.

The contributors to the development and analysis of this survey include Aaron De Smet , a senior partner in McKinsey’s New Jersey office; Kim Rubenstein, a research-science specialist in the New York office; Gunnar Schrah, a director of research science in the Denver office; Mike Vierow, an associate partner in the Brisbane office; and Amy Edmondson , the Novartis Professor of Leadership and Management at Harvard Business School.

This article was edited by Heather Hanselman, an associate editor in the Atlanta office.

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OSHA's most interesting cases

What happened – and lessons learned.

OSHA-cases.jpg

Every OSHA investigation offers an opportunity for using what comes to light to help prevent similar incidents.

At the 2022 NSC Safety Congress & Expo in September, OSHA staffers highlighted three investigations – and the lessons learned – during the agency’s “Most Interesting Cases” Technical Session.

OSHA speakers

  • Brian Elmore , an OSHA inspector based in Omaha, NE
  • Marie Lord , assistant area director of the OSHA office in Marlton, NJ
  • Peter Vo , safety engineer in OSHA’s Houston South area office

Here are the cases they presented.

  • Shelving collapse in a cold storage warehouse
  • Lockout/tagout-related amputation
  • Crane collapse  

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Patient safety and safety culture in primary health care: a systematic review

Muna habib al. lawati.

1 Faculty of Health Sciences, Discipline of Behavioral and Social Sciences in Health, The University of Sydney, Science Road, Sydney, NSW 2006 Australia

2 Department of Quality Assurance and Patient Safety, Ministry of Health, P.O.Box, 626, Wadi Al Kabir, 117 Muscat, PC Oman

Sarah Dennis

3 Ingham Institute for Applied Medical Research, Campbell Street, Liverpool, NSW 2170 Australia

4 Faculty of Health Sciences, Discipline of Physiotherapy, The University of Sydney, 71 East Street, Lidcombe, NSW 2141 Australia

Stephanie D. Short

Nadia noor abdulhadi.

5 Directorate General of Planning and Study, Ministry of Health, Muscat, Oman

Associated Data

The databases used to identify the articles were Medline, Embase, CINAHL and Scopus. Published literature were selected from 200o to 1014. The terms used in Medline search were Health System, Safety Culture, Patient Safety, Primary Health care, Adverse Event, Health Care Professionals and Health Care Managers .

Patient safety in primary care is an emerging field of research with a growing evidence base in western countries but little has been explored in the Gulf Cooperation Council Countries (GCC) including the Sultanate of Oman. This study aimed to review the literature on the safety culture and patient safety measures used globally to inform the development of safety culture among health care workers in primary care with a particular focus on the Middle East.

A systematic review of the literature. Searches were undertaken using Medline, EMBASE, CINAHL and Scopus from the year 2000 to 2014. Terms defining safety culture were combined with terms identifying patient safety and primary care.

The database searches identified 3072 papers that were screened for inclusion in the review. After the screening and verification, data were extracted from 28 papers that described safety culture in primary care. The global distribution of the articles is as follows: the Netherlands (7), the United States (5), Germany (4), the United Kingdom (1), Australia, Canada and Brazil (two for each country), and with one each from Turkey, Iran, Saudi Arabia and Kuwait. The characteristics of the included studies were grouped under the following themes: safety culture in primary care, incident reporting, safety climate and adverse events. The most common theme from 2011 onwards was the assessment of safety culture in primary care (13 studies, 46%). The most commonly used safety culture assessment tool is the Hospital survey on patient safety culture (HSOPSC) which has been used in developing countries in the Middle East.

Conclusions

This systematic review reveals that the most important first step is the assessment of safety culture in primary care which will provide a basic understanding to safety-related perceptions of health care providers. The HSOPSC has been commonly used in Kuwait, Turkey, and Iran.

Electronic supplementary material

The online version of this article (10.1186/s12875-018-0793-7) contains supplementary material, which is available to authorized users.

The World Health Organization (WHO) defines patient safety as “the prevention of errors and adverse effects to patients associated with health care” and “to do no harm to patients” [ 1 , 2 ]. There are millions of patients globally who suffer disabilities, injuries or death each year due to unsafe medical practices [ 3 ]. This has led to the wider recognition of the importance of patient safety, the incorporation of patient safety approaches into the strategic plans of health care organizations and a growing body of research in this field [ 4 ]. “To Err is Human: Building a Safer Health System” was published in 1999 by the Institute of Medicine (IOM), it emphasized that safety was the key fundamental concern. This was a landmark publication for patient safety and warned of errors in health care and the potential for patient harm [ 5 ]. Patient safety in primary care has not been explored to the same extent as in the hospital settings [ 6 ] however more recently there has been more research emerging in primary care [ 7 – 10 ]. Achieving a culture of safety requires an understanding of the values, attitudes, beliefs and norms that are important to health care organization and what attitudes and behaviors are appropriate and expected for patient safety [ 10 ].

This systematic review aimed to identify the patient safety measures used globally to assess the effectiveness of safety culture in primary care. The outcome of this study will help to inform strategies for patient safety for primary care in Oman in order to accomplish the 2050 vision. The specific research questions for this review were:

  • What processes or systems are in place to facilitate a safety culture in in primary care?
  • What are the measures used globally to assess the effectiveness of safety culture in primary care?
  • What is the impact of safety culture in primary care?

A systematic review of the published literature from 2000 to 2014 was conducted. This date range was chosen because it followed the publication of “To Err is Human” in 1999 [ 5 ]. The databases used to identify the articles were Medline, Embase, CINAHL and Scopus. The terms used in Medline search were Health System, Safety Culture, Patient Safety, Primary Health care, Adverse Event, Health Care Professionals and Health Care Managers .

There were several key definitions used to scope the review and inform the inclusion and exclusion criteria:

  • Patient Safety: WHO defines patient safety “as the absence of preventable harm to a patient during the process of health care” [ 1 ].
  • Safety Culture: Defined “as shared values, attitudes, perceptions, competencies and patterns of behaviors”.
  • Primary Care: WHO defined primary care “as socially appropriate, universally accessible, scientifically sound first level care provided by a suitably trained workforce supported by integrated referral systems (to secondary care or tertiary care) and in a way that gives priority to those most needed, maximizes community and individual self-reliance and participation and involves collaboration with other sectors. It includes the following: health promotion, illness prevention, care of the sick, advocacy and community development” [ 11 ].

Articles were included in the review if they were published in the year 2000 or later and met the following four inclusion criteria:

  • They reported on the use of patient safety tools or approaches or mechanisms or procedures used in primary health care with an impact on patient care (outcome) measured.
  • If they were contained any of the following methodologies; systematic review, intervention study (randomized controlled trials), descriptive study or qualitative design.
  • They discussed patient safety in primary care, or safety culture in primary care.
  • Published in English.

Articles were excluded if they were opinion papers/essays, editorial reviews, interviews, comments or narrative reviews.

After removal of the duplicates and papers with no abstracts, the titles and abstracts of 61 papers were screened by two researchers (MA and NN). The full text of all articles remaining were obtained and reviewed by two researchers (MA and NN). The full text articles were read and those that met the inclusion criteria were included in the review. The flow chart in Additional file  1 illustrates the selection process by using Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) flowchart [ 12 ].

The following information was extracted from the included articles: authors, year of publication, title and aims, objectives, methods, country and key findings. To assess the quality three different tools were used according to study design. Systematic reviews were evaluated by Assessing Methodological Quality of Systematic Review (AMSTAR), quantitative studies were assessed by Effective Public Health Practice Project (EPHPP) and cross sectional studies were evaluated by using Strengthening the Reporting of Observational studies in Epidemiology (STROBE) [ 13 ].

The database searches identified 3072 papers that were screened for inclusion in the review. After title and abstract screening there were 61 remaining papers that described interventions in safety culture in primary care. Following verification and data extraction there were a total number of 28 articles included in the systematic review (Additional file  1 ). The global distribution of the articles are as follows: the Netherlands (7), the United States (5), Germany (4), Australia, Canada and Brazil (two for each country), the United Kingdom (1), and with one each from Turkey, Iran, Saudi Arabia and Kuwait. The characteristics of the included studies grouped under the following themes: safety culture in primary care, incident reporting, safety climate and adverse events are specified in Table  1 .

Characteristics of the selected studies in the systematic review (studies categorized by themes)

Safety culture in primary care

Thirteen studies addressed safety culture and tools to assess safety culture in general practice and most (9/13) were cross sectional studies [ 7 , 8 , 10 , 14 – 19 ], the other studies were qualitative interviews [ 20 ], a systematic review [ 21 ], a retrospective audit [ 22 ], randomized control trial [ 22 ], mixed methods [ 23 ] and a case study [ 24 ].

The definition of patient safety culture varied among the articles. A common definition of safety culture was utilized in eight studies, which referred to shared values, perceptions, attitudes, competencies and behaviors within an organization [ 8 , 10 , 14 , 15 , 19 – 23 ]. The definition of safety culture was lacking in two articles but they defined patient safety and patient safety incidents respectively [ 18 ]. There was one study where patient safety culture was defined as acceptance and actions of patient safety as the first priority in the organization [ 7 ] and four articles did not define safety culture [ 17 , 24 – 26 ].

Two studies of safety culture utilized a qualitative approach, followed by a survey or an audit. The other eleven studies utililized quantitative tools to assess safety culture. The systematic review included a study by Gaal et al. in the Netherlands that explored the views of primary care doctors and nurses to identify aspects of care linked to patient safety in a qualitative study [ 16 ]. Medication safety was most frequently mentioned with incidents occurring in diagnosis and treatment, errors in communication and poor patient doctor relationship were the most common errors in primary care [ 25 ]. The aspects that were considered essential for patient safety were; the availability of medical instruments, telephone accessibility and safe electric sockets. General practitioners relied on the skills and knowledge of the practice nurses since most of the patients were seen by them. The GPs did not supervise the practice nurses when providing advice to patients over the phone which they felt was a threat to patient safety. The results of this qualitative study were used to develop a web-based survey, which was one of the first to assess the views of general practitioners (GPs) on patient safety [ 16 ] in the Netherlands. They found that GPs were concerned about the maintenance of medical records, prescription and monitoring of medication.

Another Dutch study identified that health care professionals who had a perception and understanding of patient safety had more incidents recorded [ 26 ]. All the health professionals surveyed felt that communication breakdown inside and outside the practice was a threat to patient safety and was associated with more incidents [ 26 ].

A systematic review on the use of interventions of patient safety that affect safety culture in primary care only included two studies [ 21 ]. One of the included studies described the implementation of an electronic medical records system in general practice using the safety attribute questionnaire as a part of patient safety improvements [ 21 ]. The authors facilitated two workshops for general practice on risk management and significant audit analysis. The authors concluded that further research was required to assess the effect of interventions on safety culture in primary care [ 21 ].

Two main tools were used to measure safety culture; the Manchester Patient Safety Framework (MaPSaF) and the Hospital Survey on Patient Safety Culture (HSOPSC). The Manchester Patient Safety Framework (MaPSaF) [ 23 ] was developed to measure the multidimensional and dynamic nature of safety culture and enabled recognition of subcultures within a single organization because subcultures act as a powerful influence on error detection and learning. In addition, the tool provided insights into patient safety culture, facilitated interactive self-reflection about safety culture of an organization, explored differences in perception among different staff categories, helped understand how mature an organization was in terms of safety culture and evaluated interventions which were aimed at improving safety culture. The MaPSaF is founded on Westrum’s typology of organizational communication from 1992, which defined how different types of organizations process information. This typology was expanded upon by Parker and Hudson to describe five levels of progressively maturing organizational safety culture. The MaPSaF measures ten dimensions of safety culture, derived from a literature review on patient safety in primary care and in-depth interviews and focus group discussions with health care professionals and managers. The dimensions are commitment to overall safety, priority given to safety; system errors and individual responsibility; recording incidents and best practice; evaluation incidents and best practice; learning and effecting change; communication about safety issues; staff education and training and team work approach. The tool helped to acknowledge that patient safety was multidimensional and complex, offered insights and demonstrated strengths and weaknesses of a patient safety culture, provided differences in perception among and helped the organization to understand what a mature safety culture in health care might look like. It should not be used to conduct performance management nor to divide or attribute blame when the organization’s safety culture is not sufficiently mature [ 27 ]. This tool is best used as a facilitative educational tool for health care providers and managers.

The Manchester Patient Safety Framework (MaPSaF) [ 14 , 22 ] has been adapted for use in different health systems. The MaPSaF was modified and tested in the New Zealand context to facilitate learning about safety culture and facilitate team communication mentioned in the systematic review [ 15 ]. The MaPSaF has been modified for use in the German health system and was renamed the Frankfurt Patient Safety Matrix (FraTix) [ 22 ]. This tool was validated and used in a randomized control trial of 60 general practices to determine safety culture at different levels. There were no differences between the general practice physicians’ groups but the intervention group showed improved reporting and management of patient safety incidents than the control group. FraTix appeared to be a good tool for self-assessments aimed at improving safety culture but did not lead to measurable improvements in error management.

The Hospital Survey on Patient Safety Culture (HSOPSC) was developed by the Agency of Health Care and Research for Hospitals in 2004, and has been adapted and modified for other health care settings. It measures healthcare professional’s perspectives towards safety culture at the individual, unit and organizational level. It was pilot tested with more than 1400 hospital employees from 21 hospitals across the USA [ 28 ]. The tool was developed after an extensive literature review on safety, accidents, medical errors, safety climate and culture and organizational climate and culture. There were also interviews with hospital staff and surveys. The instrument includes fourteen dimensions, twelve are multiple item dimensions (two safety culture dimensions and two outcome dimensions) and the last two are single item dimensions used to check the validity. This tool has a broad spectrum of applicability has been completed by all types of hospital staff from security guards to nurses, paramedical staff and physicians employed by the organization. In terms of reliability and validity the HSOPSC was found to be “psychometrically sound at the individual, unit and hospital level analysis” [ 29 ] in primary care settings. It has since been used in Kuwait, Turkey, the Netherlands and Iran [ 7 , 8 , 10 , 19 ]. The dimension most commonly scored among Kuwait, Turkey and Iran was teamwork within the units and the least was non-punitive response to errors. Similarly, the HSOPSC has since been adapted and validated for use in Dutch general practice, and was renamed SCOPE [ 19 ], a Dutch abbreviation for systematic culture on patient safety in primary care. Table  2 compares the characteristics of the MaPSaF and HSOPSC.

Comparision of Manchester Patient Safety Framework (MaPSaF) and Hospital Survey on Patient Safety Culture (HSOPSC)

Paese [ 15 ] used the Safety Attitudes Questionnaire (SAQ) to assess attitudes to safety culture in Brazilian primary care. The survey was conducted among community health agents, nursing technicians and nurses. The SAQ assesses the quality of safety and teamwork standards in a given time in a health care organization. Nine attributes are assessed which are: job satisfaction, teamwork climate, perception of work environment, communication, patient safety, ongoing education, management of the healthcare center, recognition of stress, error prevention by using preventive measures. Patient safety attribute was considered to be an important attribute among the respondents whereas prevention measures to avoid errors were viewed as being a less important attribute.

A case study in a primary care physician practice in the USA explored the impact of a comprehensive risk management program from 2003 to 2009. The program resulted in fewer insurance claims and considerable cost savings thereby enhancing patient safety culture in primary care by implementing risk management program, the program further provided the physicians’ a sense of control over the treatment of malpractice and encouraged them to provide the best care for their patients [ 24 ].

Incident reporting in primary care

Incident reporting to assess patient safety in primary care has grown in importance. There were two types of study under this theme; 1) studies that explored different approaches to incident reporting [ 6 , 30 – 34 ] and 2) different mechanism to report incidents [ 35 , 36 ].

A number of studies have looked at incident reporting mechanisms and no one method was found to be superior. A mixture of methods was required to identify adverse events in primary care. The feasibility of a locally implemented incident reporting procedure (IRP) in primary health centers was evaluated [ 33 ]. Introducing IRP in primary care to manage patient safety seemed to be less suitable for dealing with serious adverse events since it neglected the emotional needs of the healthcare workers involved in the medical error [ 33 ]. This study further compared the number and the nature of incident reports collected locally (IRP) and from the existing centralized incident reporting procedure. They found that the local incident reporting procedure enabled the health care professionals to control the assessments of their incident reports since the reports remained within the health center. This facilitated organizational learning and in turn increased the willingness to report and facilitated quicker implementation of improvement. The central procedure that collected reports from many settings, appeared to address common and recurrent safety issues more effectively. Therefore, they concluded that both approaches were necessary and should be combined [ 37 ].

A systematic review reported on the methodologies to evaluate incidents in primary care, types of incidents, contributing factors and solutions to make a safer primary care. There were 33 included articles and the most universally used method was incident analysis from incident reports (45%). The review did not report on the effectiveness of any specific method for incident reporting nor were specific tools mentioned. The most frequent types of incident were associated with medication and diagnosis errors and the most relevant contributing factor was communication failure among healthcare team [ 15 ]. Reviewing medical reports as an approach to incident reporting in primary healthcare was examined in a Dutch study mentioned in the systematic review. This retrospective review identified records with evidence of a potential patient safety incident in out-of-hours primary care and reviewed the type, causes and consequences of the incident. They found that incidents did occur in out-of-hours primary care but that most (70%) did not result in patient harm. The most frequent incident was treatment errors (56%). All incidents were attributed to failures in clinical reasoning because of lack of access to the patient’s medical history, insufficient medical knowledge, high workload, age and being high risk (patients with one or more conditions such as cardiac and vascular disease, asthma/COPD, diabetes, pregnancy, malignancy and immune disease). The mean age for patients with incidents was 52 years compared to 36 years for patients without incidents. Logistic regression analysis identified that the likelihood of an incident increased by 1.03 (95% confidence interval: 1.01 to 1.04) for each year increase in patient age the baseline age used was less or more then 50 [ 15 ].

Safety climate in primary care

Safety climate was assessed in three cross sectional studies using similar definitions of safety climate and safety culture [ 38 – 40 ]. Safety climate was defined as “shared employee perceptions of the priority of safety at their unit and organization at large” [ 38 ]. The safety climate was referred to as what was happening in an organization whereas; safety culture explained why it was happening [ 41 ].

There was no tool to assess safety climate so Hoffman et al. evaluated the use of the existing Safety Attribute Questionnaire, Ambulatory version which was piloted and modified to be used in general practice. It was renamed the Frankfurt patient safety climate questionnaire for general practice (FraSik) and was used to assess the safety climate in German general practice [ 38 ]. FraSik was further assessed in a survey which recongnises strengths and weaknesses of the safety climate of general practice and in addition too, individual and practical features that affect the safety climate perception of health care professionals in primary care [ 39 ]. Doctors and health care assistants perceived that safety climate in German general practice was positive and highlighted areas for improvement in patient safety, reporting incidents and cause of errors. A limitation of the study was a low response rate because those that responded to the survey might have an interest in patient safety and therefore more positive response and may not reflect the views other health professionals working in the system [ 39 ].

Interestingly, the terms safety climate and safety culture in the studies mentioned above have been used interchangeably although they mean different things. Safety climate is defined as “surface features of the safety culture from attitudes and perceptions of individuals at a given point in time” and “the measurable components of safety culture” [ 42 ]. Whereas, a safety culture is the “product of individual and group values, attitudes, competencies and patterns of behavior that determine the commitment to, and the style and proficiency of an organization’s health and safety programs” [ 14 ].

Adverse events in primary care

Two papers reported on adverse events with a focus on medication error [ 43 , 44 ]. Both the papers related to information technology to improve patient safety and quality of care. A systematic review, which reviewed literature on the use of drug interaction detection software (DIS) [ 43 ]. Only four studies met the inclusion criteria and they were not able to address the benefits and harms of drug interaction software for medication safety. There was no published evidence to supports these systems or policies.

An Australian study aimed to identify the features of e-prescribing software that best supported patient safety and quality of care in primary care. A list of 114 features was identified by literature review, key informant and expert groups (Delphi Process). These features could be used to develop software standards by policy makers and could be adapted in other settings and countries, but were not evaluated [ 44 ]. Another paper discussed the introduction of an electronic medical record system into primary care because of its impact to improve health care quality. The electronic medical system further includes current practice knowledge, which can support decision making, eventually leading to reduction to practice expenses and further increasing revenues by accurate billing and customer satisfaction [ 45 ].

The European Practice Assessment tool was used in a German study to assess the primary care practice focusing on the five domains in primary care practice (infrastructure, people, finance, quality and safety). Two groups where selected, the intervention group is the one which had a previous training in the tool and showed improvement in all the five domains compared to the comparative group which group which didn’t have any previous trainings. This highlighted that there is a benefit to quality improvement when accreditation tools are introduced as a benchmark assessment to improve the health care professional’s performance [ 46 ].

Patient safety is critical to health care quality and remains a developmental challenge in primary care in many countries. In addition interventions addressing patient safety culture in primary care are limited compared to secondary care [ 21 ].

To improve patient safety, an important first step is to address and understand the safety culture of an organization. Similarly assessment of safety culture helps health care organizations to assess areas for improvement and analyze changes over time [ 9 ]. This systematic review has recognized that the most common theme emerging from 2011 onwards was the assessment of safety culture in primary care. An important first strategy to improve all aspects of health care quality is creating a culture of safety within health care organizations [ 47 ].

An understanding of the safety culture is vital to improve the problematic practices or attitudes such as miscommunication, adverse events and a non-punitive response to errors, which can lead to an improvement in the safety culture of primary care. Likewise, the measurement of safety culture in primary care can help in the identification of areas for improvement which might cause adverse events and errors. Patient care follow-up, communication openness and work pressure were essential to improve patient safety in primary care [ 2 ]. Secondly, another key area for improvement seen in the systematic review was the issue of inadequate numbers of staff and providers to handle patients in primary care, highlighting this as an area that requires attention [ 7 , 8 , 10 ].

Communication breakdown, which affects both safety culture and acts as a contributing factor for incidents, needs to be emphasized and addressed to help strengthen patient safety culture in primary care [ 19 ]. Communication openness was seen in the Kuwaiti and Turkey studies as an area of concern [ 8 , 10 ] unlike in the Iranian and the Dutch studies [ 7 , 19 ]. The inconsistency between outcomes regarding communication openness might be associated with differences in cultural background where disparagement and disagreement is regarded as blame and thus can lead to loss of occupation or personal relationships among staff and therefore staff tend to avoid it. In general communication openness was found to be a problem in developing and Middle Eastern countries due to the blame culture [ 9 ]. Organizations with a positive safety culture constituted a communication policy, established the importance of safety in health care and developed preventive measures.

This systematic review brings to light an emerging literature on patient safety culture in primary care from middle to low income countries. As health care organizations attempt to improve, there is a need to establish a culture of safety an example seen in primary care in Oman.To to achive that, its essential to understand the culture of safety which requires an understanding of the values, beliefs, and norms about what is significant in an organization and what attitudes and behaviors related to patient safety are importand and suitable. Establishing an environment for patient safety may be challenging in Oman because no studies on patient safety have been undertaken in primary care, only hospital care. A further complication is that the health centers are scattered unlike hospitals which is a single unit and in addition the health care workforce includes many nationalities and backgrounds with varying understandings of patient safety from different health care systems.

The insight one may draw from the literature is that, the most reliable and effective strategy for improving the quality of care is in changing the perception of the frontline health care professionals towards patient safety which in-turn will result in reduced adverse events and communication breakdown [ 47 ].

The safety of the staff and patients in a health care organization was affected by the extent of safety perceived across the organization. This concept was assessed by two frequently used tools in the systematic review which assessed safety culture in primary care: the Manchester Patient Safety Framework (MaPSAF) and Hospital Survey on Patient Safety Culture (HSOPSC). The HSOPSC tool emerged as the most likely tool to be used in the GCC to assess the safety culture in primary care for the following reasons; firstly, it was used successfully in Kuwait and more recently in Yemen and both countries have a similar GCC primary health systems. Secondly, the same questionnaire has been used to assess the hospital safety culture in other countries in the GCC [ 48 ].

Incident reporting is an important aspect for achieving patient safety [ 6 ]. There is a need to develop an incident reporting system in primary care in the Middle East within the health centers, similar to hospitals, which is computerized and helps in tracking and following up the incidents. The findings from this systematic review suggest that the system developed should include a local incident reporting system which will record and monitor incidents within the health center along with a centralized reporting system at the ministry of health which can address and monitor incidents which are recurrent and common in primary care [ 49 ]. A local approach aids in willingness to report and facilitate quicker implementation whereas a central approach addresses the common and recurrent safety issues [ 49 ].

Patient safety in primary care is an emerging field of research in western countries but little has been published from Oman and the other Gulf Cooperation Council Countries (GCC). The Ministry of Health (MOH) in Oman has been working for many years at different levels to improve the quality of health care services and its safety.

Patient safety in primary care can be enhanced in the GCC by introducing 5 yrs plans across primary care. This such example was seen in Oman where they developed a “Vision 2050” which is updated every 5 yrs. Potential areas for improvement are introduced for the next 2020–2025 five-year plan for patient safety in primary care across all the regions of Oman. With the aid of these plans the Ministry of Health, in partnership with the Ministry of Information Technology, are working together to achieve information transfer, linkage of patient information between health centers, secondary care and hospitals so that the civil identification number can be used as a single identification number to access all patient health information across the health institutions.

This systematic review reveals that the most important first step is the assessment of safety culture in primary care which will provide basic understanding to safetyrelated perceptions of the health care providers. The most commonly used safety culture assessment tool is the HSOPSC which aids in identifying areas for improvement at the individual, unit and organizational level. This review recognized that safety culture in primary care should be assessed on a regular basis to evaluate the effectiveness of safety in health institutions.

Furthermore, results from this review will be used to inform an empirical study of safety culture in primary care in Oman using the Hospital Survey on Patient Safety Culture (HSOPSC) tool, with a view to developing a template for the development of safety culture in primary care in the context of rapid economic growth.

Additional file

PRISMA flowchart. The completed PRISMA flowchart for the systematic review. (DOC 57 kb)

Availability of data and materials

Abbreviations, authors’ contributions.

MA and NN screened the titles and abstracts of all remaining papers and the full text of all articles remaining were obtained and reviewed by two researchers MA and NN. All Authors participated in developing study method, definitions and criteria. All authors participated in the sequence in drafting the manuscript. All authors read and approved the final manuscript.

Authors information

PhD Student at the University of Sydney, Head of Quality and Patient Safety at the Directorate General of Health Services, Ministry of Health, Muscat, Oman.

Ethics approval and consent to participate

Ethical approval was obtained from Research and Ethical Review and Approval Committee in Oman.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Contributor Information

Muna Habib AL. Lawati, Email: moc.liamg@ilanumrd .

Sarah Dennis, Email: [email protected] .

Stephanie D. Short, Email: [email protected] .

Nadia Noor Abdulhadi, Email: moc.oohay@haroonaidan .

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Driving change: a case study of a dnp leader in residence program in a gerontological center of excellence.

View as pdf A later version of this article appeared in Nurse Leader , Volume 21, Issue 6 , December 2023 . 

The American Association of Colleges of Nursing (AACN) published the Essentials of Doctoral Education for Advanced Practice Nursing in 2004 identifying the essential curriculum needed for preparing advanced practice nurse leaders to effectively assess organizations, identify systemic issues, and facilitate organizational changes. 1 In 2021, AACN updated the curriculum by issuing The Essentials: Core Competencies for Professional Nursing Education to guide the development of competency-based education for nursing students. 1 In addition to AACN’s competency-based approach to curriculum, in 2015 the American Organization of Nurse Leaders (AONL) released Nurse Leader Core Competencies (updated in 2023) to help provide a competency based model to follow in developing nurse leaders. 2

Despite AACN and AONL competency-based curriculum and model, it is still common for nurse leaders to be promoted to management positions based solely on their work experience or exceptional clinical skills, rather than demonstration of management and leadership competencies. 3 The importance of identifying, training, and assessing executive leaders through formal leadership development programs, within supportive organizational cultures has been discussed by national leaders. As well as the need for nurturing emerging leaders through fostering interprofessional collaboration, mentorship, and continuous development of leadership skills has been identified. 4 As Doctor of Nursing Practice (DNP) nurse leaders assume executive roles within healthcare organizations, they play a vital role within complex systems. Demonstration of leadership competence and participation in formal leadership development programs has become imperative for their success. However, models of competency-based executive leadership development programs can be hard to find, particularly programs outside of health care systems.

The implementation of a DNP Leader in Residence program, such as the one designed for The Barbara and Richard Csomay Center for Gerontological Excellence, addresses many of the challenges facing new DNP leaders and ensures mastery of executive leadership competencies and readiness to practice through exposure to varied experiences and close mentoring. The Csomay Center , based at The University of Iowa, was established in 2000 as one of the five original Hartford Centers of Geriatric Nursing Excellence in the country. Later funding by the Csomay family established an endowment that supports the Center's ongoing work. The current Csomay Center strategic plan and mission aims to develop future healthcare leaders while promoting optimal aging and quality of life for older adults. The Csomay Center Director created the innovative DNP Leader in Residence program to foster the growth of future nurse leaders in non-healthcare systems. The purpose of this paper is to present a case study of the development and implementation of the Leader in Residence program, followed by suggested evaluation strategies, and discussion of future innovation of leadership opportunities in non-traditional health care settings.

Development of the DNP Leader in Residence Program

The Plan-Do-Study-Act (PDSA) cycle has garnered substantial recognition as a valuable tool for fostering development and driving improvement initiatives. 5 The PDSA cycle can function as an independent methodology and as an integral component of broader quality enhancement approaches with notable efficacy in its ability to facilitate the rapid creation, testing, and evaluation of transformative interventions within healthcare. 6 Consequently, the PDSA cycle model was deemed fitting to guide the development and implementation of the DNP Leader in Residence Program at the Csomay Center.

PDSA Cycle: Plan

Existing resources. The DNP Health Systems: Administration/Executive Leadership Program offered by the University of Iowa is comprised of comprehensive nursing administration and leadership curriculum, led by distinguished faculty composed of national leaders in the realms of innovation, health policy, leadership, clinical education, and evidence-based practice. The curriculum is designed to cultivate the next generation of nursing executive leaders, with emphasis on personalized career planning and tailored practicum placements. The DNP Health Systems: Administration/Executive Leadership curriculum includes a range of courses focused on leadership and management with diverse topics such as policy an law, infrastructure and informatics, finance and economics, marketing and communication, quality and safety, evidence-based practice, and social determinants of health. The curriculum is complemented by an extensive practicum component and culminates in a DNP project with additional hours of practicum.

New program. The DNP Leader in Residence program at the Csomay Center is designed to encompass communication and relationship building, systems thinking, change management, transformation and innovation, knowledge of clinical principles in the community, professionalism, and business skills including financial, strategic, and human resource management. The program fully immerses students in the objectives of the DNP Health Systems: Administration/Executive Leadership curriculum and enables them to progressively demonstrate competencies outlined by AONL. The Leader in Residence program also includes career development coaching, reflective practice, and personal and professional accountability. The program is integrated throughout the entire duration of the Leader in Residence’s coursework, fulfilling the required practicum hours for both the DNP coursework and DNP project.

The DNP Leader in Residence program begins with the first semester of practicum being focused on completing an onboarding process to the Center including understanding the center's strategic plan, mission, vision, and history. Onboarding for the Leader in Residence provides access to all relevant Center information and resources and integration into the leadership team, community partnerships, and other University of Iowa College of Nursing Centers associated with the Csomay Center. During this first semester, observation and identification of the Csomay Center Director's various roles including being a leader, manager, innovator, socializer, and mentor is facilitated. In collaboration with the Center Director (a faculty position) and Center Coordinator (a staff position), specific competencies to be measured and mastered along with learning opportunities desired throughout the program are established to ensure a well-planned and thorough immersion experience.

Following the initial semester of practicum, the Leader in Residence has weekly check-ins with the Center Director and Center Coordinator to continue to identify learning opportunities and progression through executive leadership competencies to enrich the experience. The Leader in Residence also undertakes an administrative project for the Center this semester, while concurrently continuing observations of the Center Director's activities in local, regional, and national executive leadership settings. The student has ongoing participation and advancement in executive leadership roles and activities throughout the practicum, creating a well-prepared future nurse executive leader.

After completing practicum hours related to the Health Systems: Administration/Executive Leadership coursework, the Leader in Residence engages in dedicated residency hours to continue to experience domains within nursing leadership competencies like communication, professionalism, and relationship building. During residency hours, time is spent with the completion of a small quality improvement project for the Csomay Center, along with any other administrative projects identified by the Center Director and Center Coordinator. The Leader in Residence is fully integrated into the Csomay Center's Leadership Team during this phase, assisting the Center Coordinator in creating agendas and leading meetings. Additional participation includes active involvement in community engagement activities and presenting at or attending a national conference as a representative of the Csomay Center. The Leader in Residence must mentor a master’s in nursing student during the final year of the DNP Residency.

Implementation of the DNP Leader in Residence Program

PDSA Cycle: Do

Immersive experience. In this case study, the DNP Leader in Residence was fully immersed in a wide range of center activities, providing valuable opportunities to engage in administrative projects and observe executive leadership roles and skills during practicum hours spent at the Csomay Center. Throughout the program, the Leader in Residence observed and learned from multidisciplinary leaders at the national, regional, and university levels who engaged with the Center. By shadowing the Csomay Center Director, the Leader in Residence had the opportunity to observe executive leadership objectives such as fostering innovation, facilitating multidisciplinary collaboration, and nurturing meaningful relationships. The immersive experience within the center’s activities also allowed the Leader in Residence to gain a deep understanding of crucial facets such as philanthropy and community engagement. Active involvement in administrative processes such as strategic planning, budgeting, human resources management, and the development of standard operating procedures provided valuable exposure to strategies that are needed to be an effective nurse leader in the future.

Active participation. The DNP Leader in Residence also played a key role in advancing specific actions outlined in the center's strategic plan during the program including: 1) the creation of a membership structure for the Csomay Center and 2) successfully completing a state Board of Regents application for official recognition as a distinguished center. The Csomay Center sponsored membership for the Leader in Residence in the Midwest Nurse Research Society (MNRS), which opened doors to attend the annual MNRS conference and engage with regional nursing leadership, while fostering socialization, promotion of the Csomay Center and Leader in Residence program, and observation of current nursing research. Furthermore, the Leader in Residence participated in the strategic planning committee and engagement subcommittee for MNRS, collaborating directly with the MNRS president. Additional active participation by the Leader in Residence included attendance in planning sessions and completion of the annual report for GeriatricPain.org , an initiative falling under the umbrella of the Csomay Center. Finally, the Leader in Residence was involved in archiving research and curriculum for distinguished nursing leader and researcher, Dr. Kitty Buckwalter, for the Benjamin Rose Institute on Aging, the University of Pennsylvania Barbara Bates Center for the Study of the History of Nursing, and the University of Iowa library archives.

Suggested Evaluation Strategies of the DNP Leader in Residence Program

PDSA Cycle: Study

Assessment and benchmarking. To effectively assess the outcomes and success of the DNP Leader in Residence Program, a comprehensive evaluation framework should be used throughout the program. Key measures should include the collection and review of executive leadership opportunities experienced, leadership roles observed, and competencies mastered. The Leader in Residence is responsible for maintaining detailed logs of their participation in center activities and initiatives on a semester basis. These logs serve to track the progression of mastery of AONL competencies by benchmarking activities and identifying areas for future growth for the Leader in Residence.

Evaluation. In addition to assessment and benchmarking, evaluations need to be completed by Csomay Center stakeholders (leadership, staff, and community partners involved) and the individual Leader in Residence both during and upon completion of the program. Feedback from stakeholders will identify the contributions made by the Leader in Residence and provide valuable insights into their growth. Self-reflection on experiences by the individual Leader in Residence throughout the program will serve as an important measure of personal successes and identify gaps in the program. Factors such as career advancement during the program, application of curriculum objectives in the workplace, and prospects for future career progression for the Leader in Residence should be considered as additional indicators of the success of the program.

The evaluation should also encompass a thorough review of the opportunities experienced during the residency, with the aim of identifying areas for potential expansion and enrichment of the DNP Leader in Residence program. By carefully examining the logs, reflecting on the acquired executive leadership competencies, and studying stakeholder evaluations, additional experiences and opportunities can be identified to further enhance the program's efficacy. The evaluation process should be utilized to identify specific executive leadership competencies that require further immersion and exploration throughout the program.

Future Innovation of DNP Leader in Residence Programs in Non-traditional Healthcare Settings

PDSA Cycle: Act

As subsequent residents complete the program and their experiences are thoroughly evaluated, it is essential to identify new opportunities for DNP Leader in Residence programs to be implemented in other non-health care system settings. When feasible, expansion into clinical healthcare settings, including long-term care and acute care environments, should be pursued. By leveraging the insights gained from previous Leaders in Residence and their respective experiences, the program can be refined to better align with desired outcomes and competencies. These expansions will broaden the scope and impact of the program and provide a wider array of experiences and challenges for future Leaders in Residency to navigate, enriching their development as dynamic nurse executive leaders within diverse healthcare landscapes.

This case study presented a comprehensive overview of the development and implementation of the DNP Leader in Residence program developed by the Barbara and Richard Csomay Center for Gerontological Excellence. The Leader in Residence program provided a transformative experience by integrating key curriculum objectives, competency-based learning, and mentorship by esteemed nursing leaders and researchers through successful integration into the Center. With ongoing innovation and application of the PDSA cycle, the DNP Leader in Residence program presented in this case study holds immense potential to help better prepare 21 st century nurse leaders capable of driving positive change within complex healthcare systems.

Acknowledgements

         The author would like to express gratitude to the Barbara and Richard Csomay Center for Gerontological Excellence for the fostering environment to provide an immersion experience and the ongoing support for development of the DNP Leader in Residence program. This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.

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  • Case report
  • Open access
  • Published: 10 February 2024

Detection of gene mutation in the prognosis of a patient with arrhythmogenic right ventricular cardiomyopathy: a case report

  • Dinh Phong Phan 1 , 2 ,
  • Tuan Viet Tran 1 , 2 ,
  • Vo Kien Le 1 &
  • Tuan Viet Nguyen 2  

Journal of Medical Case Reports volume  18 , Article number:  49 ( 2024 ) Cite this article

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Arrhythmogenic right ventricular cardiomyopathy (ARVC), or more recently known as arrhythmogenic cardiomyopathy (ACM), is an heritable disorder of the myocardium characterized by progressive fibrofatty replacement the heart muscle and risk of ventricular arrhythmias and sudden cardiac death (SCD). We report a case study to demonstrate the role of gene mutation detection in risk stratification for primary prevention of SCD in a young patient diagnosed with ARVC.

Case presentation

A 15-year-old Asian (Vietnamese) male patient with no history of documented tachyarrhythmia or syncope and a family history of potential SCD was admitted due to palpitations. Clinical findings and work-up including cardiac magnetic resonance imaging (MRI) were highly suggestive of ARVC. Gene sequencing was performed for SCD risk stratification, during which PKP2 gene mutation was found. Based on the individualized risk stratification, an ICD was implanted for primary prevention of SCD. At 6 months post ICD implantation, the device detected and successfully delivered an appropriate shock to terminate an episode of potentially fatal ventricular arrhythmia. ICD implantation was therefore proven to be appropriate in this patient.

Conclusions

While gene mutations are known to be an important factor in the diagnosis of ARVC according to the 2010 Task Force Criteria and recent clinical guidelines, their role in risk stratification of SCD remains controversial. Our case demonstrated that when used with other clinical factors and family history, this information could be helpful in identifying appropriate indication for ICD implantation.

Peer Review reports

Arrhythmogenic right ventricular cardiomyopathy (ARVC), or more recently known as arrhythmogenic cardiomyopathy (ACM), is an heritable disorder of the myocardium characterized by progressive myocardial changes and risk of ventricular arrhythmias and sudden cardiac death (SCD). First described in the late 1970s and early 1980s [ 1 ], histopathological characterization of the right ventricle (RV) identifies multiple changes, most notably the presence of progressive fibrofatty or fat replacement of the myocardium, leading to RV dilatation and dysfunction [ 2 ]. This process forms heterogeneous zones of the myocardium correlated with arrhythmogenic substrates, which trigger the occurrence of ventricular tachycardias (VT) and ventricular fibrillation (VF) that can lead to SCD [ 3 , 4 ]. However, recent studies have shown that biventricular involvement is more prevalent than previously thought and therefore, the term AVRC is being replaced by arrhythmogenic cardiomyopathy (ACM) [ 5 ] It has been reported that 73% of ARVC index patients carry mutations in genes encoding the desmosomal proteins [ 6 , 7 ] necessary for the maintenance of stable intercellular connections. The prevalence of these gene mutations ranges from 28 to 58% [ 8 , 9 ]. TGFB3, RYR2, TTN, TNEM43, DES, DSP, PKP2, DSG2, DSC2, JUP, PLN, LMNA, SCN5A , and CTNNA3 have all been identified as playing a role in the pathogenesis of ARVC in recent studies [ 10 ]. This finding provides the foundation for the latest recommendation in European Society of Cardiology (ESC) guidelines as well as Heart Rhythm Society (HRS) consensus to consider gene mutations as a criterion for ARVC diagnosis and risk stratification [ 11 , 12 ]. Nevertheless, the role of gene mutations in guiding treatment decisions remains controversial, particularly in the risk stratification of primary prevention of SCD [ 13 ]. We report a case study to demonstrate the role of gene mutation detection in risk stratification for treatment decisions.

A 15-year-old Asian (Vietnamese) male high school student as well as basketball player presented with the first-ever episode of palpitations. He had never had syncope or presyncope, documented arrhythmia or been diagnosed with cardiovascular diseases. His 27-year-old brother had died suddenly one year ago due to out of hospital cardiac arrest. Most likely cause of death was identified as arrhythmia by emergency physicians after other differentials such as cerebral vascular stroke, myocardial infarction, congenital and acquired cardiac disease were excluded by imaging, blood tests. On examination , his vital signs were normal with no clinical signs of heart failure. His electrocardiography (ECG) on admission (Fig.  1 ) showed frequent and various forms of premature ventricular complexes (PVC) with negative T waves in leads V1–V3.

figure 1

Electrocardiography on admission showing baseline rhythm was sinus rhythm, T wave inversion in leads V1–V3, with frequent and polymorphic premature ventricular complexes

Transthoracic echocardiography showed mildly dilated right ventricle with no other significant structural or functional abnormalities. The 24-h ECG ambulatory (Fig.  2 ) revealed significant PVC burden, accounting for 10.5% of the total number of heart beats. At least three distinct PVC morphologies were observed. There were occasionally coupled PVCs but no non-sustained or sustained VT was captured.

figure 2

24-h ambulatory Electrocardiography: two consecutive premature ventricular complexes variants were recorded

Electrophysiology (EP) study was indicated for two purposes: (1) to ablate the frequent PVCs, and (2) to conduct programmed electrical stimulation (PES) to induce sustained ventricular arrhythmias for risk stratification. During the procedure, frequent PVCs with various patterns were observed. These PVCs originated from the RV at different sites of the postero-lateral wall, proximal to the tricuspid annulus. Multiple attempts of mapping and radiofrequency ablation failed to terminate all PVCs. PES delivered at the RV apex with two extra stimuli induced non-sustained episodes of VT repeatedly (Fig.  3 ).

figure 3

Programmed electrical stimulation induced a non-sustained ventricular tachycardia

Cardiac Magnetic Resonance Imaging (MRI) showed enlarged RV with dyskinesia and reduced ejection fraction (RV ejection fraction 34.97%). An aneurysm close to the RV apex was also observed. Late-enhancement signal with Gadolinium showed diffused fatty infiltration in the RV free wall (Fig.  4 ). Left ventricular structure and function was normal (LV ejection fraction 62%).

figure 4

Cardiac Magnetic Resonance Imaging showed intramyocardial late gadolinium enhancement due to diffused fibrofatty scar involving the RV free wall

We then performed molecular-genetic analysis using next-generation sequencing (NGS) methods to identify gene mutations for further risk stratification. A mutation in the PKP2 gene which encodes Plakophilin-2 protein was identified (Fig.  5 ). The most prevalent cause of ARVC is a heterozygous mutation in this gene. So far, more than 200 mutations in the PKP2 gene have been documented, the majority of which are point mutations.

figure 5

The results of molecular-genetic analysis

Finally, patient was diagnosed with ARVC according to the Modified Task Force criteria for ARVC proposed by the International Task Force of ESC and International Society and Federation of Cardiology in 2010. The specific diagnostic criteria were:

Major criterion: cardiac MRI found RV dyskinesia and RVEF 34.97%.

Major criterion: T wave inversion in leads V1–V3 on ECG

Minor criterion: 9899 PVCs on Holter ECG.

Major criterion: the PKP2 gene mutation.

After a thorough consideration of all risk factors as well as careful discussion with the patient’s parents, we decided to implant an implantable cardioverter defibrillator (ICD) for primary prevention of SCD. Patient was initially discharged on beta-blocker (bisoprolol 5 mg daily). After one month, amiodarone 100 mg daily was started when ICD check found many episodes of non-sustained VT.

Follow-up and outcome

At 6 months follow-up, the patient experienced a spontaneous episode of fast VT or VF, a potentially fatal ventricular arrhythmia, which was successfully terminated by an ICD shock (Fig.  6 ).

figure 6

ICD detected ( A ) and delivered an appropriate shock ( C ) to terminate a fast VT or VF after a failed ATP (antitachycardia pacing) attempt ( B )

ARVC is a heritable cardiomyopathy which may cause life-threatening ventricular arrhythmias leading to SCD. Fibrofatty replacement of RV myocardium remains to be the main histopathological characteristic of the disease [ 1 , 2 ]. In 2010, the Task Force Criteria (TFC) for clinical diagnosis of the ARVC based on multiple factors was proposed by experts in the field of heart failure and cardiomyopathy. In 2019, HRS published an Expert Consensus Statement on Evaluation, Risk Stratification, and Management of Arrhythmogenic Cardiomyopathy, in which ACM is defined as the disease in heart muscle that involves the RV, left ventricle, or both [ 12 ]. The pathophysiological feature is fibrofatty infiltration of myocardium which may predispose patients to life-threatening arrhythmias and ventricular dysfunction. ACM are classified into 3 phenotypic variants including the classic ARVC, ALVC (arrhythmogenic left ventricular cardiomyopathy) and the disease involving both the ventricles. The diagnostic criteria for ARVC variant were based on major and minor criteria of the 2010 TFC [ 19 ]. Based on these diagnostic criteria, our patient met the diagnosis of definite ARVC.

In the 2010 TFC, gene mutation is considered as one of the major diagnostic criteria in the family history section. Specifically, identification of a pathogenic or likely pathogenic ACM mutation in the patient under evaluation is categorized as one of the major diagnostic criteria. Genetic analysis of our patient reveals the presence of a mutation of the PKP2 gene, which has been shown to be one of the mutations potentially related to ARVC.

The gene mutation in this patient changes a single nucleotide at the position NM_001005242.3: c.1379-2A > G belongs to the PKP2 gene’s intron region. We used Clinvar and Varsome tool to characterize the mutation and applied the American College of Medical Genetics and Genomics (ACMG) criteria to determine its pathogenicity [ 14 ]. Based on these databases, this mutation belongs to a category of mutations that have the potential to cause ARVC. PKP2  mutations are also the most common cause of ARVC in some populations. The  PKP2  gene encodes the synethis of a protein called plakophilin 2, which makes up structures called desmosomes. These structures form junctions that attach cells to one another. Abnormalities in the binding protein trigger myocardial remodeling and fat replacement process which may lead to arrthymia. PKP2 mutations play an important role in the pathogenesis and progression of ARVC [ 15 , 16 ].

According to the findings of Judith et al. the mutation detection prevalence in ARVC patients was 63%, with PKP2 mutations accounted for 46% of all mutations [ 17 ]. In addition, a study on 90 ARVC patients in China by Jingru Bao et al. [ 18 ] revealed 57 subjects (63%) having genetic mutations, 58% of which occurred in the PKP2 gene. Furthermore, the study’s findings demonstrated that ARVC patients with a gene mutation had a higher risk of VT than those without mutation. Similar finding was also observed in patients with and without PKP2 gene mutation. This suggests that gene mutations, even if occurring in a single-gene, especially the PKP2 gene, can be a predictor of the risk of cardiovascular events associated with ventricular arrhythmias and sudden death.

SCD due to ventricular arrhythmias can be prevented by ICD implantation [ 11 ]. Expert consensus has recommended that in ARVC patients, ICD is indicated for secondary prevention in patients with aborted cardiac arrest or hemodynamically unstable sustained VT, and for primary prevention in patients who have high risk of ventricular arrhythmias and SCD [ 12 ]. As our patient had no history of aborted SCD, ventricular arrhythmias associated syncope, sustained VT, or severely reduced LV ejection fraction on admission, risk factors for ventricular arrhythmias should be assessed to decide whether ICD implantation was necessary. According to the risk stratification guidelines recommended by the 2019 HRS Expert Consensus Statement on Evaluation, Risk Stratification, and Management of Arrhythmogenic Cardiomyopathy, our patient met only four minor risk factors for ventricular arrhythmias (male sex, > 1000 PVCs/24 h, RV dysfunction [34.97% on cardiac MRI] and proband status). Accordingly, the indication for primary prevention with an ICD for this patient was a class IIb recommendation with the level of evidence B. However, considering his family history with potential SCD in his older brother, the result of gene mutation and presuming that the disease’s severity may progress in the future, and with the family’s preference, a decision was made to implant an ICD for primary prevention of SCD. At 6 months post implantation, the patient experienced palpitations and near-syncope. A sustained fast VT or VF, a potentially fatal ventricular arrhythmia with an average cycle length of 229 ms, was detected and successfully terminated by an ICD shock. The decision of ICD implantation was finally proven to be appropriate for this patient.

Gene mutations are known to be an important factor in the diagnosis of ARVC according to TFC 2010 criteria and later clinical guidelines. Although the role of gene mutation in risk stratification remains controversial, it still plays an important role in individualized risk stratification and management. In this case, gene mutation, along with other clinical factors and family history, was proven to be helpful in guiding treatment decisions of ICD implantation for primary prevention of SCD in a young patient diagnosed with ARVC.

Availability of data and materials

The data supporting this study is with the author and has been included within the manuscript.

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Acknowledgements

We wish to thank the Vietnam National Heart Institute for providing us the opportunity to publish this case report.

The authors declare that they had no financial support for this case report.

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Dinh Phong Phan, Tuan Viet Tran & Vo Kien Le

Hanoi Medical University, 1 Ton That Tung St., Dong Da, Hanoi, Vietnam

Dinh Phong Phan, Tuan Viet Tran & Tuan Viet Nguyen

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Phong Phan Dinh was a major contributor in writing the manuscript. Tuan Viet Tran and Tuan Viet Nguyen coordinated the writing and managed the submission of the manuscript. Phong Phan Dinh, Vo Kien Le, Tuan Viet Tran were the main physicians in charge of providing care and implantation the ICD to the patient. All authors read and approved the final manuscript.

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Correspondence to Dinh Phong Phan .

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Phan, D.P., Tran, T.V., Le, V.K. et al. Detection of gene mutation in the prognosis of a patient with arrhythmogenic right ventricular cardiomyopathy: a case report. J Med Case Reports 18 , 49 (2024). https://doi.org/10.1186/s13256-023-04326-w

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Published : 10 February 2024

DOI : https://doi.org/10.1186/s13256-023-04326-w

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Reproductive rights in America

Research at the heart of a federal case against the abortion pill has been retracted.

Selena Simmons-Duffin

Selena Simmons-Duffin

importance of safety case study

The Supreme Court will hear the case against the abortion pill mifepristone on March 26. It's part of a two-drug regimen with misoprostol for abortions in the first 10 weeks of pregnancy. Anna Moneymaker/Getty Images hide caption

The Supreme Court will hear the case against the abortion pill mifepristone on March 26. It's part of a two-drug regimen with misoprostol for abortions in the first 10 weeks of pregnancy.

A scientific paper that raised concerns about the safety of the abortion pill mifepristone was retracted by its publisher this week. The study was cited three times by a federal judge who ruled against mifepristone last spring. That case, which could limit access to mifepristone throughout the country, will soon be heard in the Supreme Court.

The now retracted study used Medicaid claims data to track E.R. visits by patients in the month after having an abortion. The study found a much higher rate of complications than similar studies that have examined abortion safety.

Sage, the publisher of the journal, retracted the study on Monday along with two other papers, explaining in a statement that "expert reviewers found that the studies demonstrate a lack of scientific rigor that invalidates or renders unreliable the authors' conclusions."

It also noted that most of the authors on the paper worked for the Charlotte Lozier Institute, the research arm of anti-abortion lobbying group Susan B. Anthony Pro-Life America, and that one of the original peer reviewers had also worked for the Lozier Institute.

The Sage journal, Health Services Research and Managerial Epidemiology , published all three research articles, which are still available online along with the retraction notice. In an email to NPR, a spokesperson for Sage wrote that the process leading to the retractions "was thorough, fair, and careful."

The lead author on the paper, James Studnicki, fiercely defends his work. "Sage is targeting us because we have been successful for a long period of time," he says on a video posted online this week . He asserts that the retraction has "nothing to do with real science and has everything to do with a political assassination of science."

He says that because the study's findings have been cited in legal cases like the one challenging the abortion pill, "we have become visible – people are quoting us. And for that reason, we are dangerous, and for that reason, they want to cancel our work," Studnicki says in the video.

In an email to NPR, a spokesperson for the Charlotte Lozier Institute said that they "will be taking appropriate legal action."

Role in abortion pill legal case

Anti-abortion rights groups, including a group of doctors, sued the federal Food and Drug Administration in 2022 over the approval of mifepristone, which is part of a two-drug regimen used in most medication abortions. The pill has been on the market for over 20 years, and is used in more than half abortions nationally. The FDA stands by its research that finds adverse events from mifepristone are extremely rare.

Judge Matthew Kacsmaryk, the district court judge who initially ruled on the case, pointed to the now-retracted study to support the idea that the anti-abortion rights physicians suing the FDA had the right to do so. "The associations' members have standing because they allege adverse events from chemical abortion drugs can overwhelm the medical system and place 'enormous pressure and stress' on doctors during emergencies and complications," he wrote in his decision, citing Studnicki. He ruled that mifepristone should be pulled from the market nationwide, although his decision never took effect.

importance of safety case study

Matthew Kacsmaryk at his confirmation hearing for the federal bench in 2017. AP hide caption

Matthew Kacsmaryk at his confirmation hearing for the federal bench in 2017.

Kacsmaryk is a Trump appointee who was a vocal abortion opponent before becoming a federal judge.

"I don't think he would view the retraction as delegitimizing the research," says Mary Ziegler , a law professor and expert on the legal history of abortion at U.C. Davis. "There's been so much polarization about what the reality of abortion is on the right that I'm not sure how much a retraction would affect his reasoning."

Ziegler also doubts the retractions will alter much in the Supreme Court case, given its conservative majority. "We've already seen, when it comes to abortion, that the court has a propensity to look at the views of experts that support the results it wants," she says. The decision that overturned Roe v. Wade is an example, she says. "The majority [opinion] relied pretty much exclusively on scholars with some ties to pro-life activism and didn't really cite anybody else even or really even acknowledge that there was a majority scholarly position or even that there was meaningful disagreement on the subject."

In the mifepristone case, "there's a lot of supposition and speculation" in the argument about who has standing to sue, she explains. "There's a probability that people will take mifepristone and then there's a probability that they'll get complications and then there's a probability that they'll get treatment in the E.R. and then there's a probability that they'll encounter physicians with certain objections to mifepristone. So the question is, if this [retraction] knocks out one leg of the stool, does that somehow affect how the court is going to view standing? I imagine not."

It's impossible to know who will win the Supreme Court case, but Ziegler thinks that this retraction probably won't sway the outcome either way. "If the court is skeptical of standing because of all these aforementioned weaknesses, this is just more fuel to that fire," she says. "It's not as if this were an airtight case for standing and this was a potentially game-changing development."

Oral arguments for the case, Alliance for Hippocratic Medicine v. FDA , are scheduled for March 26 at the Supreme Court. A decision is expected by summer. Mifepristone remains available while the legal process continues.

  • Abortion policy
  • abortion pill
  • judge matthew kacsmaryk
  • mifepristone
  • retractions
  • Abortion rights
  • Supreme Court

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