Journal of Evidence-Based Medicine ISSN 1756-5391
ORIGINAL ATRICLE
Evidence-based medicine in plastic surgery: where did it come from and where is it going? Joseph A. Ricci1 and Naman S. Desai2 1 2
The Department of Surgery, Division of Plastic Surgery, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA The Department of Radiology, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA, USA
Keywords Cochrane database; evidence-based medicine; levels of evidence; plastic surgery; randomized controlled trial. Correspondence Joseph A Ricci, Department of Surgery, Division of Plastic Surgery, Massachusetts General Hospital, WACC 435, 55 Fruit Street, Boston, MA 02114, USA. Tel: 917-626-1979; Fax: 917-626-1979; Email: [email protected] Received 1 November 2013; accepted for publication 18 April 2014. doi: 10.1111/jebm.12096
Abstract Objectives: Evidence-based medicine, particularly randomized controlled trials, influence many of the daily decisions within plastic surgery as well as nearly every other medical specialty, and will continue to play a larger role in medicine in the future. Even though it is certainly not a new idea, evidence-based medicine continues to remain a hot topic among members of the healthcare community. As evidence-based medicine continues to grow and evolve, it is becoming more important for all physicians to understand the fundamentals of evidence-based medicine: how evidence-based medicine has changed, and how to successfully incorporate it into the daily practice of medicine. Results: Admittedly, the wide acceptance and implementation of evidence-based medicine has been slower in surgical fields such as plastic surgery given the difficulty in performing large scale blinded randomized controlled trials due to the inherent nature of a surgical intervention as a treatment modality. Despite these challenges, the plastic surgery literature has recently begun to respond to the demand for more evidence-based medicine. Conclusions: Today’s plastic surgeons are making a concerted embrace evidencebased medicine by increasing the amount of out of high-level clinical evidence and should be encouraged to continue to further their endeavors in the field of evidence-based medicine in the future.
Introduction The notion of practicing Evidence-Based Medicine (EBM) is believed by many to have been first conceived in the 1970’s; however, its origins can be traced even further back to Paris in the mid 19th century (1). Even though it is not a new idea, EBM continues to remain a hot topic among members of the healthcare community, including physicians, hospital administrators, public health practitioners, as well as the general public and the media (1). Although the concept of EBM has been widely embraced by many physicians, not all share a similar enthusiasm. Early critics of EBM often claimed it to be a tool used to cut costs and suppress a clinician’s autonomy to practice the art of medicine (1). Despite these detractors, EBM has become increasingly incorporated into the daily lives of physicians and will continue to play an even larger role in the day-to-day practice of medicine. As EBM continues to grow and evolve, it is becoming more important 68
for all physicians to understand the fundamentals of EBM, how EBM has changed, and how to successfully incorporate it into the daily practice of medicine.
What is EBM? EBM aims to apply the best available evidence gained from the scientific method to clinical decision-making (2). It seeks to assess the strength of evidence, weighing the risks and benefits of treatments (including the lack of treatment) or diagnostic tests (3). When applied to fields other than medicine, such as dentistry or nursing, EBM is referred to as evidencebased practice (EBP). According to Sackett, EBM or EBP can be defined as the sensible and judicious use of the best available evidence derived from systematic research to make decisions about the care of individual patients (1). The practice of EBM involves more than just utilizing the best
C 2014 Chinese Cochrane Center, West China Hospital of Sichuan University and Wiley Publishing Asia Pty Ltd JEBM 7 (2014) 68–71
J. A. Ricci and N. S. Desai
available systematic research to make decisions about patient care. It is the assimilation of the best available external research with an individual physician’s experience with the goal of solidifying the scientific foundation of medicine and to reduce uncertainties in medical decision-making (1, 4). From this definition of EBM, it is important to garner that clinical research and clinical experience are not mutually exclusive, but rather need to work together for patients to receive the full benefit of EBM; a subtle point about EBM that was missed by its early critics. Additionally, EBM is designed to deliver the best possible care to an individual patient, a tradition deeply rooted in the historical foundations of medicine. Therefore, it is important for physicians to utilize clinical judgment to assess the course and effects of an intervention and make adjustments as necessary, regardless of the treatment course initially dictated by EBM (4). The search for the best available research to support an EBM patient care decision is itself as difficult of a task as utilizing EBM in the everyday practice of medicine (4). A large impediment to physicians locating the best research is the time investment required to perform such comprehensive research. Many physicians have schedules that are busy enough without trying to search for evidence upon which they will base each patient care decision (5). Additionally, with the development and growth of the internet and online publications, the search is further complicated by the vast number of articles which need to be reviewed to determine which the best resource is (5). Even for a conscientious physician with ample free time, these problems can be cumbersome and difficult to overcome. However, the use of systematic reviews can help address these issues since unlike traditional reviews they adhere to reproducible methods and recommended guidelines (6). The Cochrane Database of Systematic Reviews, maintained by the Cochrane Collaboration, is an example of perhaps the most well known catalog of systematic reviews utilized by physicians. Widely available around the world via the internet, the Cochrane Database Reviews are meta-analysis of all available RCTs performed to evaluate an intervention with a recommendation on the use of that intervention at the end of the review (4, 7). The Cochrane Collaboration, one of the leaders in the field of EBM is named for the 20th century British epidemiologist, Archie Cochrane (4, 7). In 1971, Cochrane published his now famous monograph entitled “Effectiveness and Efficiency. Random reflections on Health Services” which gained him more international acclaim than his achievements as an epidemiologist (7). Throughout his career, which led him from a medical director and prisoner of a German prisoner-of-war camp to a researcher studying prisoners with tuberculosis, Cochrane was continually disturbed by the absence of evidence on the effectiveness of treatments used by physicians at the time (7). In order to find that evidence, Cochrane became a staunch supporter of the randomized control trial (RCT) and
Evidence-based medicine in plastic surgery
was one of the first major promoters of using RCTs in medical research (4, 7). In his monograph, Cochrane proposed that a medical intervention be considered effective only if it has been demonstrated, preferably by a RCT, that the intervention does more good than harm (7). He further wrote that these criteria should be applied to older established treatments as well as the newer ones and, in addition, applied to diagnostic tests and screening procedures as well (7).
EBM in Clinical Practice Cochrane was a believer in creating an efficient healthcare system, which would utilize all its available resources to maximize the delivery of useful interventions to patients. As a result, he became a champion among physicians for the RCT, which was able to delineate medical interventions as effective or ineffective (7). In its simplest form, an RCT assigns patients arbitrarily to either the experimental group or the control group randomly. Among all known types of study design, RCTs form the heart of the research upon which EBM is based, because they provide the best evidence supporting or rejecting the use of a particular intervention. Because of the strong evidence they provide, the Center for EvidenceBased Medicine (CEBM) has designated RCTs a Level 1 piece of clinical evidence (the highest level) on their Level of Evidence Scale (8). The level of evidence approach is an explicit way of ranking evidence. It is not only used in making clinical practice recommendations but also as a research tool. Most systems put the highest value on randomized controlled clinical trials, especially those that have sufficient statistical power to support negative findings. The most widely accepted level of evidence scale comes from the CEBM. This scale organizes research studies into categories that range from Level 1, the highest level of evidence, to Level 5, the lowest level of evidence, based on the strength, reliability and reproducibility of the results (8). Each level of evidence can then be further broken down into several subtypes as well (8). Table 1 outlines the various levels of evidence as defined by the CEBM as well as which type of studies comprise each level (8). Based on the level of evidence available for a given treatment option, the CEBM assigns a grade summarizing the strength of their recommendation for the use of that intervention in the treatment of a patient (8). These grades range from Grade A, which is the most strongly recommended treatment option because it is backed up by several Level 1 studies with consistent results, to Grade D, which is the weakest level of recommendation for a particular treatment (8). Table 2 below provides a summary of these grades summarizing treatment recommendations cumulatively based on the available evidence for that intervention (8).
C 2014 Chinese Cochrane Center, West China Hospital of Sichuan University and Wiley Publishing Asia Pty Ltd JEBM 7 (2014) 68–71
69
Evidence-based medicine in plastic surgery
Table 1 Levels of evidence and corresponding research studies Level
Description
1a 1b 1c 2a 2b
Systematic reviews of RCTs Individual RCTs (with narrow confidence interval) All or none randomized controlled trials Systematic reviews of cohort studies Individual cohort study (including low quality RCTs, e.g.,
ORIGINAL ATRICLE
Evidence-based medicine in plastic surgery: where did it come from and where is it going? Joseph A. Ricci1 and Naman S. Desai2 1 2
The Department of Surgery, Division of Plastic Surgery, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA The Department of Radiology, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA, USA
Keywords Cochrane database; evidence-based medicine; levels of evidence; plastic surgery; randomized controlled trial. Correspondence Joseph A Ricci, Department of Surgery, Division of Plastic Surgery, Massachusetts General Hospital, WACC 435, 55 Fruit Street, Boston, MA 02114, USA. Tel: 917-626-1979; Fax: 917-626-1979; Email: [email protected] Received 1 November 2013; accepted for publication 18 April 2014. doi: 10.1111/jebm.12096
Abstract Objectives: Evidence-based medicine, particularly randomized controlled trials, influence many of the daily decisions within plastic surgery as well as nearly every other medical specialty, and will continue to play a larger role in medicine in the future. Even though it is certainly not a new idea, evidence-based medicine continues to remain a hot topic among members of the healthcare community. As evidence-based medicine continues to grow and evolve, it is becoming more important for all physicians to understand the fundamentals of evidence-based medicine: how evidence-based medicine has changed, and how to successfully incorporate it into the daily practice of medicine. Results: Admittedly, the wide acceptance and implementation of evidence-based medicine has been slower in surgical fields such as plastic surgery given the difficulty in performing large scale blinded randomized controlled trials due to the inherent nature of a surgical intervention as a treatment modality. Despite these challenges, the plastic surgery literature has recently begun to respond to the demand for more evidence-based medicine. Conclusions: Today’s plastic surgeons are making a concerted embrace evidencebased medicine by increasing the amount of out of high-level clinical evidence and should be encouraged to continue to further their endeavors in the field of evidence-based medicine in the future.
Introduction The notion of practicing Evidence-Based Medicine (EBM) is believed by many to have been first conceived in the 1970’s; however, its origins can be traced even further back to Paris in the mid 19th century (1). Even though it is not a new idea, EBM continues to remain a hot topic among members of the healthcare community, including physicians, hospital administrators, public health practitioners, as well as the general public and the media (1). Although the concept of EBM has been widely embraced by many physicians, not all share a similar enthusiasm. Early critics of EBM often claimed it to be a tool used to cut costs and suppress a clinician’s autonomy to practice the art of medicine (1). Despite these detractors, EBM has become increasingly incorporated into the daily lives of physicians and will continue to play an even larger role in the day-to-day practice of medicine. As EBM continues to grow and evolve, it is becoming more important 68
for all physicians to understand the fundamentals of EBM, how EBM has changed, and how to successfully incorporate it into the daily practice of medicine.
What is EBM? EBM aims to apply the best available evidence gained from the scientific method to clinical decision-making (2). It seeks to assess the strength of evidence, weighing the risks and benefits of treatments (including the lack of treatment) or diagnostic tests (3). When applied to fields other than medicine, such as dentistry or nursing, EBM is referred to as evidencebased practice (EBP). According to Sackett, EBM or EBP can be defined as the sensible and judicious use of the best available evidence derived from systematic research to make decisions about the care of individual patients (1). The practice of EBM involves more than just utilizing the best
C 2014 Chinese Cochrane Center, West China Hospital of Sichuan University and Wiley Publishing Asia Pty Ltd JEBM 7 (2014) 68–71
J. A. Ricci and N. S. Desai
available systematic research to make decisions about patient care. It is the assimilation of the best available external research with an individual physician’s experience with the goal of solidifying the scientific foundation of medicine and to reduce uncertainties in medical decision-making (1, 4). From this definition of EBM, it is important to garner that clinical research and clinical experience are not mutually exclusive, but rather need to work together for patients to receive the full benefit of EBM; a subtle point about EBM that was missed by its early critics. Additionally, EBM is designed to deliver the best possible care to an individual patient, a tradition deeply rooted in the historical foundations of medicine. Therefore, it is important for physicians to utilize clinical judgment to assess the course and effects of an intervention and make adjustments as necessary, regardless of the treatment course initially dictated by EBM (4). The search for the best available research to support an EBM patient care decision is itself as difficult of a task as utilizing EBM in the everyday practice of medicine (4). A large impediment to physicians locating the best research is the time investment required to perform such comprehensive research. Many physicians have schedules that are busy enough without trying to search for evidence upon which they will base each patient care decision (5). Additionally, with the development and growth of the internet and online publications, the search is further complicated by the vast number of articles which need to be reviewed to determine which the best resource is (5). Even for a conscientious physician with ample free time, these problems can be cumbersome and difficult to overcome. However, the use of systematic reviews can help address these issues since unlike traditional reviews they adhere to reproducible methods and recommended guidelines (6). The Cochrane Database of Systematic Reviews, maintained by the Cochrane Collaboration, is an example of perhaps the most well known catalog of systematic reviews utilized by physicians. Widely available around the world via the internet, the Cochrane Database Reviews are meta-analysis of all available RCTs performed to evaluate an intervention with a recommendation on the use of that intervention at the end of the review (4, 7). The Cochrane Collaboration, one of the leaders in the field of EBM is named for the 20th century British epidemiologist, Archie Cochrane (4, 7). In 1971, Cochrane published his now famous monograph entitled “Effectiveness and Efficiency. Random reflections on Health Services” which gained him more international acclaim than his achievements as an epidemiologist (7). Throughout his career, which led him from a medical director and prisoner of a German prisoner-of-war camp to a researcher studying prisoners with tuberculosis, Cochrane was continually disturbed by the absence of evidence on the effectiveness of treatments used by physicians at the time (7). In order to find that evidence, Cochrane became a staunch supporter of the randomized control trial (RCT) and
Evidence-based medicine in plastic surgery
was one of the first major promoters of using RCTs in medical research (4, 7). In his monograph, Cochrane proposed that a medical intervention be considered effective only if it has been demonstrated, preferably by a RCT, that the intervention does more good than harm (7). He further wrote that these criteria should be applied to older established treatments as well as the newer ones and, in addition, applied to diagnostic tests and screening procedures as well (7).
EBM in Clinical Practice Cochrane was a believer in creating an efficient healthcare system, which would utilize all its available resources to maximize the delivery of useful interventions to patients. As a result, he became a champion among physicians for the RCT, which was able to delineate medical interventions as effective or ineffective (7). In its simplest form, an RCT assigns patients arbitrarily to either the experimental group or the control group randomly. Among all known types of study design, RCTs form the heart of the research upon which EBM is based, because they provide the best evidence supporting or rejecting the use of a particular intervention. Because of the strong evidence they provide, the Center for EvidenceBased Medicine (CEBM) has designated RCTs a Level 1 piece of clinical evidence (the highest level) on their Level of Evidence Scale (8). The level of evidence approach is an explicit way of ranking evidence. It is not only used in making clinical practice recommendations but also as a research tool. Most systems put the highest value on randomized controlled clinical trials, especially those that have sufficient statistical power to support negative findings. The most widely accepted level of evidence scale comes from the CEBM. This scale organizes research studies into categories that range from Level 1, the highest level of evidence, to Level 5, the lowest level of evidence, based on the strength, reliability and reproducibility of the results (8). Each level of evidence can then be further broken down into several subtypes as well (8). Table 1 outlines the various levels of evidence as defined by the CEBM as well as which type of studies comprise each level (8). Based on the level of evidence available for a given treatment option, the CEBM assigns a grade summarizing the strength of their recommendation for the use of that intervention in the treatment of a patient (8). These grades range from Grade A, which is the most strongly recommended treatment option because it is backed up by several Level 1 studies with consistent results, to Grade D, which is the weakest level of recommendation for a particular treatment (8). Table 2 below provides a summary of these grades summarizing treatment recommendations cumulatively based on the available evidence for that intervention (8).
C 2014 Chinese Cochrane Center, West China Hospital of Sichuan University and Wiley Publishing Asia Pty Ltd JEBM 7 (2014) 68–71
69
Evidence-based medicine in plastic surgery
Table 1 Levels of evidence and corresponding research studies Level
Description
1a 1b 1c 2a 2b
Systematic reviews of RCTs Individual RCTs (with narrow confidence interval) All or none randomized controlled trials Systematic reviews of cohort studies Individual cohort study (including low quality RCTs, e.g.,
