© Springer-Verlag London 2014
Justin B. Dimick and Caprice C. Greenberg (eds.)Success in Academic Surgery: Health Services ResearchSuccess in Academic Surgery10.1007/978-1-4471-4718-3_1111. Studying What Happens in the OR
(1)
Wisconsin Surgical Outcomes Research Program, Department of Surgery, University of Wisconsin Hospitals and Clinics, 600 Highland Avenue H4/730, Madison, WI 53792-7375, USA
Abstract
Despite significant attention from both the healthcare community and the population at large, limited improvements have been made in patient safety over the last decade. Given the frequency with which adverse events occur in surgery, and in the operating room in particular, this is a critical area to target for improvements. Traditional quantitative retrospective approaches to research are limited in their ability to advance this field. For this reason, we must expand our armamentarium to include research at the point of care. In this chapter, we will present an overview of the available approaches to data collection and analysis as well as the critical steps to performing this type of research. We will also discuss several representative research studies focusing on point-of-care research in the operating room.
Keywords
Patient safetyPerformance improvementSystems engineeringHuman factors engineeringObservational field studiesFocus groups and interviews11.1 Introduction
It has been over a decade since the landmark Institute of Medicine reports To Err is Human and Crossing the Quality Chasm catapulted issues of quality and safety to center stage in healthcare. With the discovery that 44,000–98,000 patients die as a result of preventable medical errors each year in the United States, major emphasis has been placed on improving the quality and safety of health care.
Health-care adverse events cost our nation an estimated $393 billion to $958 billion dollars annually and represents up to 45 % of our health care expenditures [1]. For this reason, one approach has been to use financial incentives to decrease adverse events. For example, the Centers for Medicare and Medicaid (CMS) no longer reimburse hospitals for the additional costs related to “never events”, specific hospital-acquired conditions thought to represent an implicit error in the delivery of health care. Examples of CMS never events include retained foreign objects after surgery, catheter-associated blood stream infections, and stage III and IV decubitus ulcers.
Given the voluminous literature documenting a relationship between procedural volume and outcome, other policy initiatives aim to channel certain patients or procedures to high volume centers or designated centers of excellence that meet a defined set of criteria, with the aim of creating health care systems better suited to caring for complex conditions.
Regional initiatives such as the Pennsylvania Patient Safety Authority, which mandates reporting of adverse events across the state while providing protections against liability for reporters, have increased reporting and subsequently provided data available for analysis of the extent of the problem.
Finally, databases have been established to track quality-related outcomes for various patient populations. In 2004, the American College of Surgeons established the National Surgical Quality Improvement Project (ACS NSQIP), originally developed for the Veterans’ Affairs system, to track and report risk-adjusted outcomes reports on their performance relative to similar hospitals nationally. The goal is to use such bench-marked data to identify areas in quality and safety to target for quality improvement initiatives.
Unfortunately, evidence suggests that significant advances in patient safety remain unrealized despite these initiatives. An article published by Landrigan et al. failed to detect an improvement in the rate of adverse event or preventable adverse events across hospitals in North Carolina from 2002 to 2007 [2].
Contemporaneous to these policy and quality improvement initiatives that have been underway, the biomedical community has increased its efforts to better understand problems in quality and safety, and increased funding has been made available for relevant projects. For example, the Agency for Healthcare Research and Quality (AHRQ) funding portfolio for patient safety has increased and a new study section specific to this area was created in 2011.
A number of notable scientific advances have been made. The research community has developed increasingly sophisticated methodologies for analyzing large, complex data sets, and these methodologies have been applied to claims data and national databases. While such analyses can identify patterns, such as regional variations in care, and associations, such as the relationship between surgical volume and outcome, they cannot provide any real insight as to the etiology of these associations or cause and effect. “Big picture” quantitative analysis may help identify problems but are limited in their ability to inform methods for improvement.
Another analytic approach relies on retrospective analysis of adverse events and near misses, and seeks to identify contributing factors which, if addressed, could prevent future events. This type of retrospective or root cause analysis can be performed for a series of incidents identified from safety reporting systems and malpractice claims series, or for single, ‘sentinel’ events. While this method can predict both future problems and solutions, its retrospective nature can introduce significant recall bias and requires both the occurrence and detection of an adverse outcome. This reliance limits the researcher’s ability to detect, investigate, and better understand successful compensatory strategies and ‘near misses.’
Traditionally, very little health care research has taken place in real time at the point of care. Point-of-care work, also referred to as fieldwork due to the front-line nature of its investigation, offers an exciting and under-utilized approach to improving the delivery of healthcare.
In this chapter, we will provide an overview of research at the point of care, beginning with a discussion of various conceptual frameworks with an emphasis on the Systems Engineering Initiative in Patient Safety (SEIPS) model. [3]. We will explore the importance of strong collaboration, methodological approaches to data collection, discussing field observations, video analysis, and interviews, approaches to data analysis, and methods for optimal presentation and dissemination of research findings. Finally, we will provide examples of several seminal studies in surgery, with an emphasis on point-of-care research in the operating room (OR) and an aim to highlight the critical role of multi-disciplinary care in this type of research.
11.2 Key Steps in Point-of-Care Research
To successfully execute a point-of-care research project, the researcher must consider several aspects of project development. Careful attention to team development, identification of a conceptual model, and forethought regarding optimal presentation and dissemination of results will allow the researcher not only to collect relevant data but have a context in which to enact relevant change.
Six Key Steps in Point-of-Care Research
1.
Identify collaborators
2.
Develop or adapt a conceptual framework
3.
Decide on data collection and sampling strategies
4.
Determine approach to analysis
5.
Consider optimal presentation of results
6.
Disseminate results and implement change
11.2.1 Identify Collaborators
Other disciplines, including education, business, psychology, and engineering, have long been studying issues of quality and safety, and have therefore developed conceptual models and methodological tools useful for studying these problems in healthcare. By identifying collaborators in other fields and utilizing tools already developed for research purposes, researchers interested in studying quality and safety in healthcare can increase the pace of research and reduce redundancy and the need to ‘reinvent the wheel.’
Two closely-tied disciplines worth mentioning specifically are human factors and systems engineering and cognitive and organizational psychology. Human factors engineering seeks to optimize system performance (http://www.iea.cc/) and is commonly involved in safety projects. Human factors engineering principles have guided safety-reliability studies in other high-risk fields including aviation, transportation, and nuclear science, resulting in improvements in safety. Cognitive psychology focuses on aspects of human attention, memory, multi-tasking, and problem-solving and can be utilized to better understand how healthcare providers function within a work system, deal with competing responsibilities, and make decisions under high-stress circumstances. Many human factors and cognitive psychology analyses involve observational studies, and result in more qualitative/descriptive data than physicians may be accustomed to, but can provide critical information about how healthcare providers and/or patients function within a healthcare system.
Additionally, collaboration with key administrative and front-line personnel within the healthcare organization is vital to the success of a point-of-care research project. Early discussions with frontline personnel can identify practical concerns and potential flaws in a research plan which might lead to workflow disruptions and personnel/patient inconvenience. Identification of frontline ‘champions’ can help researchers deliver key information regarding the goals and importance of a proposed project. Buy-in from such stakeholders will provide support and legitimacy to a research project, and is vital to ensuring adequate provider participation.
11.2.2 Develop or Adapt a Conceptual Framework
In order to successfully understand the interactions between patients, providers, and the healthcare environment, we as practitioners must broaden our conceptualization of how care is delivered. In order to study the operating room using point-of-care research, we need to adjust the way we view the operating room: it must be thought of as a system. It is a complex assembly of people, information, resources, equipment and procedures working toward a common goal. In comparison, the traditional medical mindset has been that a patient’s physician is the sole determinant of outcome, and this culture has been slow to change. While we have been taught to feel personal responsibility for all aspects of care, it is critical to understand that even the best individual provider cannot provide totally safe care within a flawed system. All aspects of the healthcare system must be evaluated and understood in order to identify vulnerabilities.
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