In recent decades, the expansion of health services research has created an opportunity to crate salient, evidence-based guidelines for diagnosis, treatment, and prognosis. However, for many aspects of care, incorporation of new scientific knowledge into clinical practice often lags, particularly among the surgical subspecialties. This article highlights the development of evidence-based medicine, the principles of innovation diffusion, and successes and challenges in developing plastic surgery quality initiatives.
Key points
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The diversity of plastic surgery creates a unique and challenging opportunity to develop quality initiatives.
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Close attention to the principles of innovation dissemination can improve the adoption of quality initiatives.
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Innovative research with rigorous methodology is the cornerstone of developing quality initiatives that ensure patient safety and surgical quality.
Overview: the evolution of the quality of care movement
In recent decades, the accelerating cost of health care has sparked scrutiny of the quality of medical and surgical care delivered in the United States. For example, in the 1990s, evidence-based medicine (EBM) evolved to integrate clinical expertise, research evidence, and patient preferences to create the most appropriate evidence for clinical decision making. In 1996, Sackett and colleagues defined EBM as “the conscientious and judicious use of current best evidence from clinical care research in the management of individual patients.’’ Furthermore, in 1999 and 2001, the Institute of Medicine published 2 landmark reports, “To Err is Human: Building a Safer Health System” and “Crossing the Quality Chiasm,” which highlighted disparities in health care throughout the United States and the financial and societal implications of these variations. These efforts underscored a national interest in using high-quality data to drive quality improvement efforts and create equal and accessible health care for all Americans.
Variation in health care may signal overuse, underuse, or misuse of health care resources, depending on the clinical context. Understanding the mechanisms that underlie variation has been the focus of a large proportion of health care policy and research. For example, when scientific knowledge is unused or inadequately disseminated, variation may occur because of the inappropriate use of therapies and medical tests. Therefore, a quality initiative program can be designed to improve the process of delivering health care by using scientific evidence to identify and minimize variation, develop relevant benchmarks, and create strategies to achieve these goals. Quality initiatives have been developed by federal and professional organizations to measure physician and hospital performance and adherence to recommended guidelines. For example, the US Centers for Medicare & Medicaid Services (CMS) collaborated with the Hospital Quality Alliance and the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) to make measures of hospital performance publically available through the Hospital Compare program. This program has resulted in improvement in patient outcomes, such as declines in mortality, hospital length of stay, and readmission rates. Therefore, developing effective quality initiative programs can measurably enhance the efficiency and quality of health care in the United States.
Creating and implementing quality initiatives
Although disparities and variations in care have been widely studied, the development and implementation of effective quality initiatives is challenging and often elusive. However, the process of information diffusion throughout a community has been well described in the social sciences, and the principles can be applied to health care. As outlined by Berwick in 2003, the factors that influence dissemination can be categorized in the following way: perceptions of the initiative, characteristics of the community, and characteristics of the environment ( Table 1 ).
| Factor | Involved Participants | Examples | Strategies |
|---|---|---|---|
| Perceptions | Clinicians Patients Policy makers Payers | Benefit Risk Costs Consequences (short and long term; positive and negative) | Education Transparent communication |
| Population | Initiative developers, leaders, executors, adopters of the initiative | Administrators, researchers, academic and community physicians | Foster early innovators, communicate with skeptics, facilitate uptake across most |
| Context | Leadership style Organizational structure and stability | Hierarchical structure Financial stability Ancillary support Patient population | Financial incentives Creating leadership roles within the organizational structure |
| Initiative | Compatibility Complexity Testability Observability | Community needs Simplicity of the initiative Ability to assess before and after effects Clarity of outcomes | Periodic efficiency and effectiveness checks Simple, easily implemented initiatives |
Perception of the Initiative
For a quality initiative to be adopted, physicians, patients, and policy makers must have full understanding of the risks, benefits, and consequences of the initiative. For example, many aesthetic and reconstructive procedures can be safely performed in office-based ambulatory care facilities. However, in response to several patient deaths in office-based facilities, more stringent regulations were introduced by state and federal licensure committees to ensure patient safety. Despite the increased cost and restrictions of these accreditation procedures, most outpatient plastic surgery procedures continue to be performed in office-based settings, and surgeons have recognized the need for more rigorous safety policies. Quality initiatives must also be perceived as congruent with the needs of the population. For example, in 2011, the US Food and Drug Administration recognized the potential association between breast implants and anaplastic large cell lymphoma (ALCL) among patients who present with late periprosthetic seromas. In response to this concern, the American Society of Plastic Surgeons (ASPS) created a prospective registry of patients presenting with ALCL. Given the vast number of women with breast implants for augmentation or reconstruction, this registry can define the natural history of periprosthetic seromas, elucidate risk factors for ALCL, and better inform women of the long-term risks of breast implants. In addition, the initiative must be perceived as simple and cost-effective. For example, in 2002, the ASPS launched a national clinical outcomes registry, Tracking Operations and Outcomes in Plastic Surgery (TOPS) in order for surgeons to submit sociodemographic, clinical, and outcomes data for benchmarking and evaluation. This dataset currently includes information for more than 500,000 cases and 1 million procedures, and allows surgeons readily to track and evaluate their patient outcomes.
Characteristics of the Community
In addition to perception, the characteristics of the population that will implement the initiative influence its adoption. In 1943, a classic study of the rate of adoption of hybrid corn seed among Iowa farmers showed the principles of how innovation is incorporated throughout a community. This analysis revealed a sinusoidal diffusion of the use of hybrid seed corn among farmers over time. Early adoption of hybrid corn is slow, and limited to a few farmers. However, a rapid phase of adoption then occurs, with a large number of farmers quickly changing their practice. The final phase is marked by most farmers using hybrid corn, and only a small minority failing to adopt it ( Fig. 1 ). Each phase has characteristic features of the adopters. The innovators are the first to incorporate new changes, and are more tolerant of risk. In contrast, the laggards or skeptics are the last to introduce the initiative into their clinical practice, and tend to be more risk averse or traditionalists. In general, initiatives gain momentum and more widespread acceptance when approximately 15% to 20% of the initiative has been adopted. Therefore, the ability of innovators to initiate change within their environment is critical to initiate diffusion.
Characteristics of the Environment
In addition to how the intervention is perceived and the characteristics of the adopters, environmental factors also influence the diffusion of initiatives. For example, the leadership and dynamics of the organization may be more or less favorable toward adopting new innovations. There may be external incentives readily available to those who adopt the initiative. For example, the use of information technology is higher among physicians who receive financial incentives compared with physicians who do not.
Within this framework, several principles emerge for developing successful quality initiatives ( Fig. 2 ). First, a successful quality initiative relies on sound, high-quality evidence that is relevant to the patient population of interest. In addition, strong leadership by key stakeholders is needed to champion the initiative and spark interest and investment from the community. Furthermore, innovators are needed who will adopt the initiative early. Transparency and communication between policy makers and adopters can provide continuous feedback and optimization of the initiative. Examples of quality initiatives in plastic surgery are discussed later in this article.
Creating and implementing quality initiatives
Although disparities and variations in care have been widely studied, the development and implementation of effective quality initiatives is challenging and often elusive. However, the process of information diffusion throughout a community has been well described in the social sciences, and the principles can be applied to health care. As outlined by Berwick in 2003, the factors that influence dissemination can be categorized in the following way: perceptions of the initiative, characteristics of the community, and characteristics of the environment ( Table 1 ).
| Factor | Involved Participants | Examples | Strategies |
|---|---|---|---|
| Perceptions | Clinicians Patients Policy makers Payers | Benefit Risk Costs Consequences (short and long term; positive and negative) | Education Transparent communication |
| Population | Initiative developers, leaders, executors, adopters of the initiative | Administrators, researchers, academic and community physicians | Foster early innovators, communicate with skeptics, facilitate uptake across most |
| Context | Leadership style Organizational structure and stability | Hierarchical structure Financial stability Ancillary support Patient population | Financial incentives Creating leadership roles within the organizational structure |
| Initiative | Compatibility Complexity Testability Observability | Community needs Simplicity of the initiative Ability to assess before and after effects Clarity of outcomes | Periodic efficiency and effectiveness checks Simple, easily implemented initiatives |
Perception of the Initiative
For a quality initiative to be adopted, physicians, patients, and policy makers must have full understanding of the risks, benefits, and consequences of the initiative. For example, many aesthetic and reconstructive procedures can be safely performed in office-based ambulatory care facilities. However, in response to several patient deaths in office-based facilities, more stringent regulations were introduced by state and federal licensure committees to ensure patient safety. Despite the increased cost and restrictions of these accreditation procedures, most outpatient plastic surgery procedures continue to be performed in office-based settings, and surgeons have recognized the need for more rigorous safety policies. Quality initiatives must also be perceived as congruent with the needs of the population. For example, in 2011, the US Food and Drug Administration recognized the potential association between breast implants and anaplastic large cell lymphoma (ALCL) among patients who present with late periprosthetic seromas. In response to this concern, the American Society of Plastic Surgeons (ASPS) created a prospective registry of patients presenting with ALCL. Given the vast number of women with breast implants for augmentation or reconstruction, this registry can define the natural history of periprosthetic seromas, elucidate risk factors for ALCL, and better inform women of the long-term risks of breast implants. In addition, the initiative must be perceived as simple and cost-effective. For example, in 2002, the ASPS launched a national clinical outcomes registry, Tracking Operations and Outcomes in Plastic Surgery (TOPS) in order for surgeons to submit sociodemographic, clinical, and outcomes data for benchmarking and evaluation. This dataset currently includes information for more than 500,000 cases and 1 million procedures, and allows surgeons readily to track and evaluate their patient outcomes.
Characteristics of the Community
In addition to perception, the characteristics of the population that will implement the initiative influence its adoption. In 1943, a classic study of the rate of adoption of hybrid corn seed among Iowa farmers showed the principles of how innovation is incorporated throughout a community. This analysis revealed a sinusoidal diffusion of the use of hybrid seed corn among farmers over time. Early adoption of hybrid corn is slow, and limited to a few farmers. However, a rapid phase of adoption then occurs, with a large number of farmers quickly changing their practice. The final phase is marked by most farmers using hybrid corn, and only a small minority failing to adopt it ( Fig. 1 ). Each phase has characteristic features of the adopters. The innovators are the first to incorporate new changes, and are more tolerant of risk. In contrast, the laggards or skeptics are the last to introduce the initiative into their clinical practice, and tend to be more risk averse or traditionalists. In general, initiatives gain momentum and more widespread acceptance when approximately 15% to 20% of the initiative has been adopted. Therefore, the ability of innovators to initiate change within their environment is critical to initiate diffusion.
Characteristics of the Environment
In addition to how the intervention is perceived and the characteristics of the adopters, environmental factors also influence the diffusion of initiatives. For example, the leadership and dynamics of the organization may be more or less favorable toward adopting new innovations. There may be external incentives readily available to those who adopt the initiative. For example, the use of information technology is higher among physicians who receive financial incentives compared with physicians who do not.
Within this framework, several principles emerge for developing successful quality initiatives ( Fig. 2 ). First, a successful quality initiative relies on sound, high-quality evidence that is relevant to the patient population of interest. In addition, strong leadership by key stakeholders is needed to champion the initiative and spark interest and investment from the community. Furthermore, innovators are needed who will adopt the initiative early. Transparency and communication between policy makers and adopters can provide continuous feedback and optimization of the initiative. Examples of quality initiatives in plastic surgery are discussed later in this article.
Related posts:
Patient-Reported Outcomes Instruments
The Outcomes Movement and Evidence-Based Medicine in Plastic Surgery
Development and Psychometric Evaluation of the FACE-Q Satisfaction with Appearance Scale
Measuring Outcomes in Craniofacial and Pediatric Plastic Surgery
Measuring Outcomes in Hand Surgery
Measuring Outcomes in Lower Limb Surgery
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