We define artefacts as the implements, notes, or materials that are used in the daily workflow of patient care. Artefact analysis is the study of these implements.  Cognitive artefacts are man-made implements that seem to aid or enhance our cognitive abilities. Some examples include calendars, to-do lists, electronic mails, phone texts, phone messages, computer screen printouts, or simply tying a string around your finger as a reminder.

Cognitive artefacts are widely used in healthcare and include items such as an operating theatre whiteboard, end-of-shift sign-out sheet, surgery schedule or a written sign-out that are used as reminders of what needs to be completed for patient care. Study artefacts can help one better understand how clinicians perceive and actually do their work.  

Ref: Johnson, J, Arora V, Barach P. What can artefact analysis tell us about patient transitions between the hospital and primary care? Lessons from the HANDOVER project. European Journal of General Practice, 2013; 19: 185–193.

The Aristotle risk assessment scoring system stratifies patient risk based on the potential for morbidity, mortality and the anticipated technical difficulty of a given procedure. Assessing quality of care by assigning surgical operations a risk score or grouping operations of similar risk into categories. The Aristotle Basic Complexity (ABC) score methodologic details of developed the ABC score. The score includes potential for mortality, potential for morbidity, and technical difficulty for each operation contribute up to 5 points each to this continuous score (range 1.5 to 15). The score was used by its authors to group the procedures as follows: level 1, scores 1.5 to 5.9; level 2, scores 6 to 7.9; level 3, scores 8 to 9.9; and level 4, scores 10 to 15.

Ref: Karamichalis J, Barach P, Henaine R, Nido del P. Bacha E. Assessment of Surgical Competency in Pediatric cardiac surgery. Progress in Pediatric Cardiology – January 2012;Vol. 33; 1 15-20, DOI: 20110.1016/j.ppedcard.2011.12.003.

Barach, P., Johnson, J., Ahmed, A., Galvan, C., Bognar, A., Duncan, R., Starr, J., Bacha, E. Intraoperative Adverse Events and their impact on Pediatric Cardiac Surgery: A Prospective Observational Study. Journal of Thoracic and Cardiovascular Surgery 2008 Dec; 136 (6): 1422-1428.

Cognitive task analysis  (CTA) is used to explore complex decision making in healthcare. Cognitive task analysis focuses on the operator’s mental representation of the knowledge and skills required to perform tasks and is also a tool for exploring how operators’ cognitive processes come into play during task performance. Probes are used to explore cues, goals, strategies, and information needs during each step of the work action being studied.

Ref: Militello L, Gordon H, Flanagan M, Rattray N, Frankel R, Rehman S, Franks Z, Barach P. “Workin’ on Our Night Moves”: How residents prepare for shift handoffs. The Joint Commission Journal on Quality and Patient Safety, 2018, https://doi.org/10.1016/j.jcjq.2018.02.005

Rattray N, Militello L, Gordon H, Flanagan M,, Barach P Frankel R, Rehman S, Franks Z. Content Counts, but the Context Makes a Difference in Developing Expertise: A Qualitative Study of How Residents Learn End of Shift Handoffs. BMC Medial Educat, 2018.doi.org/10.1186/s12909-018-1350-8.

Aviation distinguishes between ‘normal’, ‘non-normal’ and ‘emergency’ checklists. ‘Normal’ checklists are used as part of standard operating procedures. They include lists used for preparation of a flight or technical checks by maintenance staff. Emergency’ checklists deal with uncommon, and unexpected crisis situations likely to have catastrophic outcomes.

Ref: Subbe, C, Kellet J, Barach P. et al. Crisis checklists for in-hospital emergencies: expert consensus, simulation testing and recommendations for a template determined by a multi-institutional and multi- disciplinary learning collaborative. BMC Health Services Research (2017) 17:334 DOI 10.1186/s12913-017-2288-y.

Ethnography is a qualitative research study looking at the social interaction of users in a given environment. This research provides an in-depth insight into the user’s views and actions along with the sights and sounds they encounter during their day. It provides the researcher with an understanding of how those users see the world and how they interact with everything around them.

Ethnography methods include direct observation, diary studies, video recordings, photography and artefact analysis such as devices that a person uses throughout the day. Observations can be made anywhere from the user’s workplace, their home or while they are out with family and friends. The length of the studies can vary depending on the research that is being conducted. They can range from a couple of hours of observation, to studies that last several months.

Ethnographic studies are a good way to really understand your users and the challenges they may face while going about their everyday lives. The research will give you insights to your users that you may not have seen if they were in a lab being asked to complete a task.

Ref: Schraagen JM, Schouten A, Smit M, van der Beek D, Van de Ven J. Barach P. Improving methods for studying teamwork in cardiac surgery. Qual Saf Health Care 2010;19:1-6 doi:10.1136/qshc.2009.040105

Barach, P., Johnson, J., Ahmed, A., Galvan, C., Bognar, A., Duncan, R., Starr, J., Bacha, E. Intraoperative Adverse Events and their impact on Pediatric Cardiac Surgery: A Prospective Observational Study. Journal of Thoracic and Cardiovascular Surgery 2008 Dec; 136 (6): 1422-1428.

Galvan, C., Bacha, B., Mohr, J., Barach, P. A Human Factors Approach to Understanding Patient  Safety during Pediatric Cardiac Surgery. Progress in Pediatric Cardiology 2005;20:13– 20.

GCM is an integrated mixed method, including both qualitative and quantitative measures. It uses a structured approach to identify an expert group’s understanding about the types, methods and characteristics of healthcare work and

Multivariate statistical techniques of multidimensional scaling and hierarchical cluster analysis (HCA) are used to translate complex qualitative data into conceptual maps. A group concept map shows all the specific ideas about a particular topic (eg, handover educational interventions). The map also indicates how ideas are related to other ideas. In addition, the map indicates how much emphasis should be placed on a particular idea or cluster relative to other ideas (eg, how relatively important or feasible to implement a given intervention is, vis-a-vis other proposed approaches).

Ref: Stoyanov S, Bouschizen E, Groene O, M, W Hendrick H, Barach P. Mapping handover educational interventions. British Medical Journal Quality and Safety, 10.1136/bmjqs-2012-001169.

The method of Human Reliability Analysis aims to identify and surface the potential failures of the system resulting from human errors, analyze causes and identify appropriate countermeasures to prevent and reduce the linked risk and resultant patient harm. These methods are well-accepted and integrated into the safety management process in most industries. These methods allow the investigation of medical error and patient harm and to develop the applications of these methods to the problem of adverse reactions to treatment and other associated risks in healthcare.

Ref: Barach P, Levashenko V, Zaitseva E. Application of Fuzzy Decision Trees in Medical Decision-Making Support Systems, Human Factors and Ergonomics Society, March 21-24, Chicago, 2019.

The Influence Diagram demonstrates how the interplay of some of the issues associated with human characteristics and work context, and help explore the factors that can contribute to the tendency for a false assumption by providers. The arrows in this diagram represent influences, these diagrams are often referred to as influence diagrams, which represent a type of modeling framework. Similarly, influence diagrams could also be constructed to model omissions in the communication of patient information during sign-out reporting (for example, stemming from interruptions during work activities).

Ref: Sharit J, McCane L, Thevenin DM, Barach P. Examining Links Between Sign-Out Reporting During Shift Changeovers and Patient Management Risks. Risk Anal. 2008;28(4):983-1001.

IM is a systematic, iterative six-step process that helps to develop an intervention, based on theoretical, empirical and practical information

Step 1: Problem analysis

Structure the problem analysis by using the PRECEDE PROCEED model to analyse and describe the scale, causes, and consequences of the health problem and to identify the target population.

Step 2: Identify intervention outcomes, performance objectives and change objectives

Identify the desired outcomes of the intervention and formulated specific performance objectives for the target population, such as writing a complete, accurate and timely discharge letter by the hospital physician.

It is important to identify what steps need to be tweaked in order to affect the performance objective, and ultimately the intervention outcome. We identified the most important determinants (e.g., lack of knowledge and understanding between hospital and primary care providers) that need to be changed and combined these with performance objectives to formulate our change objectives. These change objectives specified who and what will change as a result of the intervention.

Step 3: Selection of theory-based methods and strategies

Selecte theory-based methods that relate to the change objectives in step 2. These methods are required to change the behavioural and environmental determinants of ineffective hospital discharge. Subsequently, these methods were translated into practical strategies.

Step 4: Develop an intervention

Provide suggestions for the design of the intervention by considering the target group and local setting.

Steps 5 and 6: Implementation and Evaluation

Make suggestions for developing an implementation plan for accomplishing program adoption, and for evaluating the effects and feasibility of the intervention program. The suggestions were based on literature regarding effective implementation strategies, existing implementation toolboxes, and a literature review on methods to evaluate complex interventions in health care.

Ref: Hesselink G, Zegers M, Vernooij-Dassen M, Barach P, et al: European HANDOVER Research Collaborative. Improving patient discharge and reducing hospital readmissions by using Intervention Mapping. BMC Health Services Research 2014 Sep 13;14:389. doi: 10.1186/1472-6963-14-389.

Ref: Johnson, Barach P, Vernooij-Dassen, M, Conducting a multicenter and multinational qualitative study on patient transitions, BMJ Qual & Safety 2012;0:1–7. doi:10.1136/bmjqs-2012-001197.

Sharit J, McCane L, Thevenin DM, Barach P. Examining Links Between Sign-Out Reporting During Shift Changeovers and Patient Management Risks. Risk Anal. 2008;28(4):983-1001.

The clinical Microsystems is centered around the needs of the patient and provides a service. To succeed, the microsystem must: (1) do the work; (2) meet both patient and staff needs; and, (3) maintain themselves as a functioning clinical unit.

The clinical microsystem, as an organizational construct, is a systems approach for

providing healthcare based on theories from organizational development, leadership,

and improvement.  The success characteristics reflect what people working in high-performing practices say about their work and how they go about achieving their work. The characteristics of a clinical microsystem are summarized below. The MAT Survey tool assesses all critical aspects of the processes with targeted questions and with open-ended questions.

Ref:

Göbel B, Zwart D, Hesselink G, Pijnenborg L, Barach P, Kalkman C, Johnson JK. Stakeholder perspectives on handovers between hospital staff and general practitioners: an evaluation through the microsystems lens. BMJ Qual Saf. 2012 Dec;21 Suppl 1:i106-13. doi: 10.1136/bmjqs-2012-001192. Epub 2012 Nov 1.

Mohr, J., Barach, P., Cravero, J., Blike, G., Godfrey, M., Batalden, P., & Nelson, E. Microsystems in Health Care. Joint Commission Journal on Quality and Safety 2003;29:401-408.

A process map or flowchart is a visual representation of the care process that is created with information provided by team members. The process mapping exercise can help clinicians clarify through visualization what they know about their environment and determine what they want to improve about it. The process maps use common flowchart symbols and can describe the current state or baseline, the improved state in transition, and the optimal state. The exercise helps clinicians make assumptions and expectations explicit and can provide insights into reflecting on their current state and, importantly, into how to improve the process of care or

to overcome barriers they perceive to its improvement. Visualizing the process can also help identify inefficiencies (e.g., parallel or redundant processes that have emerged for whatever reason), clarify roles, and reduce ambiguity among team members, all of which can help coordinate patient care.

Ref:

Johnson J, Barach P. Tools and Strategies for Continuous Quality Improvement and Patient Safety. In Sanchez J, Barach P, Johnson H, Jacobs J (eds.). Perioperative Patient Safety and Quality: Principles and Practice, Springer, 2017, ISBN 978-3-319-44010-1.

Ref: Barach, P., Johnson, J., Ahmed, A., Galvan, C., Bognar, A., Duncan, R., Starr, J., Bacha, E. Intraoperative Adverse Events and their impact on Pediatric Cardiac Surgery: A Prospective Observational Study. Journal of Thoracic and Cardiovascular Surgery 2008 Dec; 136 (6): 1422-1428

Root cause analysis (RCA) is a systematic process for identifying “root causes” of problems or events and an approach for responding to them. RCA is based on the basic idea that effective management requires more than merely “putting out fires” for problems that develop, but finding a way to prevent them.

A root cause is defined as a factor that caused a nonconformance and should be permanently eliminated through process improvement. The root cause is the core issue—the highest-level cause—that sets in motion the entire cause-and-effect reaction that ultimately leads to the problem(s).

Root cause analysis (RCA) is defined as a collective term that describes a wide range of  approaches, tools, and techniques used to uncover causes of problems. Some RCA approaches are geared more toward identifying true root causes than others, some are more general problem-solving techniques, and others simply offer support for the core activity of root cause analysis.

APPROACHES TO ROOT CAUSE ANALYSIS

There are many methodologies, approaches, and techniques for conducting root cause analysis, including:

1. Events and causal factor analysis:Widely used for major, single-event problems, such as a refinery explosion, this process uses evidence gathered quickly and methodically to establish a timeline for the activities leading up to the accident. Once the timeline has been established, the causal and contributing factors can be identified. 
2. Change analysis:This approach is applicable to situations where a system’s performance has shifted significantly. It explores changes made in people, equipment, information, and more that may have contributed to the change in performance.
3. Barrier analysis:This technique focuses on what controls are in place in the process to either prevent or detect a problem, and which might have failed.
4. Management oversight and risk tree analysis:One aspect of this approach is the use of a tree diagram to look at what occurred and why it might have occurred. 
5. Kepner-Tregoe Problem Solving and Decision Making:This model provides four distinct phases for resolving problems:
   1. Situation analysis
   2. Problem analysis
   3. Solution analysis
   4. Potential problem analysis

Ref:

Cassin B, Barach P. Making sense of root cause analysis investigations of surgery-related adverse events. Surg Clin North Am. 2012;92:101-15.

Culture can be defined as the collection of individual and group values, attitudes, and practices that guide the behavior of group members. Characteristics of a strong safety culture include a commitment to discuss and learn from errors, recognition of the inevitability of errors, proactive identification of latent threats, and incorporating nonpunitive systems for reporting and analyzing adverse events. Studies of safety culture have focused mainly on discovering deficits in organization, communications, or personal skills.

We designed a Questionnaire based on scaled questions e taken from validated studies to explore areas of known importance described in the safety culture literature. In addition, new areas were described, and scaled questions were formulated based on the clinical experience of our research team members. A clinical scenario and a set of open-ended questions were added to the scaled questions to increase the validity and interpretability of the study.

Ref: Bognar A, Barach P, Johnson J, Duncan R. Woods D, Holl J, Birnbach D, Bacha E. Errors and the Burden of Errors: Attitudes, Perceptions and the Culture of Safety in Pediatric Cardiac Surgical Teams. Ann Thoracic Surgery 2008;(4);1374-1381.

A scoping literature review can be used to identify the gaps in research. Scoping reviews are a traceable method of ‘mapping’ areas of research and highlighting gaps in the literature for future research. Scoping reviews are a useful tool to identify gaps in evidence synthesis approaches and require rigorous and transparent methods to ensure that the results are trustworthy. This methodology summarizes the evidence available on a topic in order to convey the breadth and depth of that topic by mapping the existing literature in a field of interest in terms of the volume, nature and characteristics of the primary research and identify gaps in the existing literature.

Ref:

Subbe C, Barach P. Impact of Electronic Health Records on Pre-defined Safety Outcomes in Patients Admitted to Hospital. A Scoping Review, BMJ Open, 2021;11:e047446. doi:10.1136/bmjopen-2020-047446

The pre-surgial miniSTAR consisted of the following questions:

1. Did you receive, in your opinion, sufficient information about the child scheduled for the operation?
2. Did you sleep well last night?
3. Are you troubled or distracted by any physical or mental stress that could possibly affect your performance during the operation?
4. Are you concerned about the performance of other team members during this operation?

The scores of the four questions were collapsed into one score, with a minimum of 0 (indicating optimal preparation) and a maximum of 7 (indicating serious concerns about team preparedness and readiness).

The post-operation miniSTAR was completed immediately after the operation. It consisted of the following questions:

1. Did you do anything that should not have been done or done differently, even though this may not at all have led to patient harm?
2. Did you notice that other team members did something that had better not been done or done differently, even though this may not at all have led to patient harm?
3. Did you notice that you or others had done anything that should not have been done or done differently, and which has occurred before?
4. Was the operation carried out in a pleasant and harmonious atmosphere?
5. Did you notice any conflicts among team members and how were they resolved?

Ref: Schraagen JM, Schouten A, Smit M, van der Beek D, Van de Ven J. Barach P. A prospective study of paediatric cardiac surgical microsystems: assessing the relationships between non-routine events, teamwork and patient outcomes. BMJ Qual Saf 2011. doi:10.1136/ bmjqs .2010.048983.

Non technical skills (NTS) encompass a range of competencies, including communication, teamwork, leadership, decision making, situational awareness, managing stress, and coping with fatigue. In contrast to methods of evaluating technical skills, the assessment of NTS almost exclusively relies on rating scales and checklists that include specific definitions and examples of behaviors representing superior or substandard performance at each measured NTS.

These tools can be used in both the simulated and actual clinical environment, and rely on direct observation of subjects.  Several instruments have been created to evaluate NTS with considerable overlap, demonstrating the importance of some of these competencies to a number of academic surgical teams. Some of these instruments are discussed below.

To achieve high reliability and consistent performance, each team member must be able to (1) anticipate the needs of the others; (2) adjust to each other’s actions and to the changing environment; (3) monitor each other’s activities and distribute workload dynamically; and (4) have a shared understanding of accepted processes, and how events and actions should proceed (shared mental model).

Ref: Schraagen JM, Schouten T Barach P. Assessing and improving teamwork in cardiac surgery. Qual Saf Health Care. 2010;19:e29.

Baker, D. Battles J, King H, Salas, E., Barach, P. The Role of Teamwork in the Professional Education of Physicians: Current Status and Assessment Recommendations. Joint Commission Journal on Quality and Safety 2005; 31:4:185-202.

Schraagen JM, Schouten A, Smit M, van der Beek D, Van de Ven J. Barach P. A prospective study of paediatric cardiac surgical microsystems: assessing the relationships between non-routine events, teamwork and patient outcomes. BMJ Qual Saf 2011. doi:10.1136/ bmjqs 2010.048983.

The Electronic Team Survey (ETS) is designed to collect information about the roleof the patient and the culture of reporting that might influence team members’ dailywork and subsequent outcomes. It is a mixed methods survey, combining qualitative and quantitative methods.

The first section of the ETS asks participants to: “Briefly describe ONE event from today that stands out in your mind from your work related to patients. Describe your feelings about this work, your experience of this work, or your team’s experience of this work. The event you describe can be positive, negative, or neutral.”

The ETS gives participants the opportunity to reflect, in real time, on their role in creating value, and upon the work culture process by which safety is created or undermined.

High-reliability organizational theory posits that organizational features including psychological safety, leadership involvement and a relentless culture of quality measurement are needed to sustain reliable improvements in care. We defined the work system to include the persons,

organization, tools and technologies, tasks and their work environment. Work environment is the physical and organizational culture under which healthcare professionals perform their tasks.

Ref: Brubakk K, Svendsen MV, Hofoss D, Barach P, Tjomsland O. Associations between work satisfaction, engagement and 7-day patient mortality: a cross-sectional survey. BMJ Open 2019;9:e031704. doi:10.1136/