- Email: [email protected]
Measuring Outcomes in Ambulatory Surgery
Measuring Outcomes in Ambulatory Surgery Todd Francone, MD,* and Rocco Ricciardi, MD, MPH†,‡ The list of ambulatory procedures has grown considerably in the last half century. Colorectal procedures are particularly amenable to the ambulatory setting because of the volume of cases, minimally invasive techniques employed, and relatively quick recovery. Although we know that colon and rectal surgeons perform an increasing number of anorectal and endoscopic procedures in ambulatory surgery centers, useful metrics for outcomes assessment are lacking in this arena. In this review, we have summarized the data regarding outcomes assessment in ambulatory colorectal surgery, delineated the complexities of outcomes measurement, and suggested strategies for future assessment. Semin Colon Rectal Surg 22:217-221 © 2011 Elsevier Inc. All rights reserved.
A
ccording to the Centers for Disease Control and Prevention’s National Center for Health Statistics, the number of visits to freestanding ambulatory surgery centers increased about 300% from 1996 to 2006, whereas the rate of visits to hospital-based surgery centers remained largely unchanged during that time.1 A total of 57.1 million ambulatory procedures were performed as a component of 34.7 million patient visits in 2006.1 The list of ambulatory procedures has grown considerably spanning surgical and medical specialties, including endoscopy, lens extraction, and spinal canal injections.1 Colorectal procedures are particularly amenable to the ambulatory setting because of the volume of cases, minimally invasive techniques employed, and quick recovery. The most commonly used definition for ambulatory surgery includes those surgical interventions that are more complex than office-based procedures performed under local anesthesia but less complex than major procedures requiring at least an overnight stay.2 Today this definition has expanded to include a long list of short stay procedures that surgeons as well as other clinicians perform. Given the proposed advantages of ambulatory surgery, such as more rapid return to the comforts of a home environment, decreased potential for nosocomial complications, and diminished cost,3 these techniques have grown in acceptance. In addition, it is assumed that the number of ambulatory surgery procedures will continue to grow as new technologies convert inpatient cases to the outpatient setting.
*Department of Surgery, University of Rochester, Rochester, NY. †Department of Colon and Rectal Surgery, Lahey Clinic, Burlington, MA. ‡Tufts University, Boston, MA. Address reprint requests to: Rocco Ricciardi, MD, MPH, Department of Colon and Rectal Surgery, Lahey Clinic, 41 Mall Road, Burlington, MA 01805. E-mail: [email protected]
1043-1489/$-see front matter © 2011 Elsevier Inc. All rights reserved. doi:10.1053/j.scrs.2011.06.005
Given the increasing number of ambulatory surgical procedures, the assessment of outcomes has become more and more critical to assess and assure high-quality care. However, much of the current published literature focuses in on outcomes and quality of care at the inpatient level, evaluating more traditional outcomes, such as morbidity and mortality, or cost considerations. Nevertheless, it has become apparent that most colorectal procedures performed in an ambulatory setting have low rates of adverse events.4-8 Thus, surgeons and other interested stakeholders question whether traditional outcomes measures are pertinent to improving quality of care in the outpatient setting. Nontraditional outcomes, such as long-term complications, bowel and genitourinary function, quality of life, and other more patient-centered outcomes, may provide more suitable data needed to improve the quality of care in the outpatient setting. Although we know that colon and rectal surgeons perform an increasing number of anorectal and endoscopic procedures in ambulatory surgery centers, useful metrics for outcomes assessment are lacking in this arena. A review of the literature reveals few studies, lack of standardized definitions, and poor or inconsistent follow-up as contributing to the complexity and current lack of outcomes data in ambulatory surgery. In this review, we have summarized the data regarding outcomes assessment in ambulatory colon and rectal surgery, delineated the complexities of outcomes measurement, and suggested strategies for future work.
Present-Day Knowledge Much of the outcomes literature in the ambulatory care setting has come from small cases series and large administrative databases. Each type of database has strengths and weaknesses that limit generalizability while containing varying 217
218 levels of medical detail. Fleisher et al used outpatient surgical encounter data from the Agency for Healthcare Research and Quality (AHRQ) to report the rates of inpatient hospital admission and death rates following ambulatory surgery.9 AHRQ provided data based on New York State discharges with information on patient’s age, medical diagnosis, type of anesthesia, and procedure code. Over 783,539 patients were evaluated in the study. The study revealed that hospital admissions following outpatient surgery were low. Further analysis showed patients with extended operating time longer than 120 minutes, cardiovascular comorbidity diagnoses, malignancy, human immunodeficiency virus, and regional or general anesthesia were at higher risk of hospital admission.9 An outpatient surgery admission index was proposed as a guide to assist in identifying patients at a higher risk of immediate hospital admissions. Recognizing that clinical data were needed to evaluate outcomes in more detail, Mezei and Chung established a prospective database of preoperative, intraoperative, and postoperative data from a single ambulatory surgery center in Toronto.10 In this study of 17,638 consecutive patients, longterm follow-up was reported to adequately assess overall safety in a range of ambulatory surgery procedures. The authors reported intraoperative adverse events on standardized event sheets and postoperative follow-up was recorded at 30 days. Admissions following outpatient surgery were identified using the Canadian Institute of Health Information database. The authors reported an admission rate of 1.1% within 30 days and a complication-related readmission rate of 0.15%. Only 1 procedure was shown to predict inpatient admission from a long list of outpatient procedures, transurethral resection of bladder tumor.10 This study provided longer term follow-up data to help guide quality improvement strategies at the local and global level. In the area of ambulatory colon and rectal surgery, a large number of anorectal and endoscopic procedures are performed by colon and rectal surgeons as well as gastroenterologists and general surgeons. At this time, outcomes assessment in ambulatory colon and rectal surgery have focused on traditionally collected measures of morbidity and mortality, and a growing body of evidence evaluating costs. It should be of no surprise that most studies of ambulatory colorectal surgery identify few if any complications or postoperative sequelae.4-8 For example, in 1 study using a prospective quality tracking tool, investigators identified infrequent complications after common anorectal procedures, such as pilonidal cystectomy, hemorrhoidectomy, sphincterotomy, abscess drainage, and/or fistulotomy.6 In this study of over 900 index anorectal procedures, an overall complication rate of ⬍5% was noted with only 1 major complication related to the procedure.6 The authors also identified few minor complications, such as urinary retention, minor bleeding, wound infection, and urinary tract infection. Although the data are useful in documenting complications, when 1 considers these results in their context, an argument that traditional outcome metrics are of little importance in guiding clinical management can be made.
T. Francone and R. Ricciardi Similar to the findings with anorectal procedures, the incidence of complications following lower gastrointestinal endoscopy is also relatively low, despite serious complications, such as colonic perforation.7,8,11 Levin et al attempted to address the quality and magnitude of colonoscopy complications by identifying colonoscopy morbidity within 30 days from procedure. Of the 16,318 procedures identified by review of the Kaiser Permante integrated electronic medical record system, 183 complications were identified (1.1%).12 Similarly, in another study of 43,609 colonoscopies performed at the Carolinas Medical Center, 14 perforations (1 in 3115 procedures) were identified with few other complications.7 In addition to colonic perforations, immediate postpolypectomy bleed is relatively underreported, while data regarding delayed postpolypectomy bleed is absent.13 A study of 1354 polypectomies revealed procedural bleeding in 17 patients (1.3%), while 1 patient experienced perforation.8 These data reveal that endoscopic procedures are relatively safe with infrequent yet serious complications. There has been an effort to standardize colonoscopy reporting by the Quality Assurance Task Group of the National Colorectal Cancer Roundtable.14 This effort developed in response to the growing body of literature documenting variation in the quality of colonoscopy. The group developed key quality indicators for both reporting of procedures and the proper use of data generated by the system. Key data elements include preoperative (bowel preparation quality), intraoperative (cecal intubation rates, withdrawal times, adverse events), and postoperative procedural factors (hospitalization, complications, and documentation of follow-up).14 Basic auditing is then recommended to monitor quality and to identify specific elements for continuous quality improvement.
Cost Considerations Cost-effectiveness is an important consideration in the provision of medical care. While the determination of effectiveness following ambulatory surgery has been largely superficial, cost has been studied intensely. In addition to the cost of technology, the single greatest component of increased health care expenditures is in the cost of inpatient hospital care.15 Thus, a reduction in hospital charges of 25-50% has been described3 when an inpatient surgical procedure is transferred to the ambulatory setting. Nevertheless, there are data to suggest that although hospital costs are reduced with ambulatory procedures, much of this savings is due to shifting of costs to the patient and family in the form of home care.16 These data point to the importance of efforts to return patients to their preoperative functional level more quickly to reduce cost shifting from the hospital to the patient or family.17 An increased effort to transition many procedures to the ambulatory setting has led many to raise the concern for inpatient admission after outpatient surgery and its associated additional costs. Readmission and costs were evaluated in outpatients undergoing same day surgery in 1 retrospective study at an academic, tertiary-care institution. The au-
Measuring outcomes in ambulatory surgery thors found a higher than expected rate of inpatient admissions contributing substantially to overall costs, which they deemed both unnecessary and avoidable.18 Given these data, one can conclude that complications following ambulatory surgery are uncommon, and if inpatient admission is avoided, outpatient procedures can lead to cost savings for hospitals. It should be clear, however, that a firm grasp of cost-effectiveness requires a more detailed understanding of procedural effectiveness than is currently appreciated.
Difficulty in Assessment The current anorectal ambulatory surgery data are based on retrospective analyses or small prospective case-series leading to a limited knowledge base. Investigators interested in evaluating ambulatory surgery outcomes have encountered several difficulties. One of the greatest limitations in outcomes assessment for colorectal ambulatory procedures is requirement for minimal follow-up. Endoscopic procedures, such as screening colonoscopy, typically require no followup. Shortcomings in patient follow-up are due to the generally less complex nature of the operations performed in ambulatory surgery centers. This lack of follow-up is in sharp contrast with prospectively designed inpatient studies that report close follow-up. In addition, the interval of follow-up has also been variable with ambulatory surgery procedures varying from as little as 48-72 hours to several days.19,20 Given the poor follow-up, an assessment of readmission and complications is difficult following ambulatory surgery. Lack of validated datasets poses another limitation for those who wish to study outcomes in ambulatory surgery. The present-day surgical databases have been derived for inpatient investigations and are not well suited for answering specific questions pertaining to ambulatory surgery. These datasets that include ambulatory procedures are often incomplete and lack details regarding disease severity, comorbidity, and surgical indications. Critical medical information is often lacking or absent, adding to the relative doubt in validity of the conclusions. Given the difficulty identified with retrospective analyses of ambulatory surgery, a validated, risk-adjusted and complete data reporting mechanism is needed to evaluate outcomes following outpatient procedures. Unfortunately, maintaining a prospective database is labor-intensive, time-consuming, and very expensive. High volumes and lack of standardized data entry add to an already difficult task. A larger issue with outcome assessment in ambulatory surgery is the lack of standardized metrics, which are more commonly available in other settings (ie, American College of Surgeons National Surgical Quality Improvement Project).21 This dataset provides specific diagnoses as well as providing a defined period of follow-up. Most importantly, the National Surgical Quality Improvement Project provides validated metrics that have been developed to detect and characterize adverse events using a risk-adjusted, outcomes-based program.21 Unfortunately, in the area of ambulatory surgery, similar pertinent and validated metrics are lacking; optimal follow-up is not clear, and interest has been lacking. In the
219 future, data must be developed specifically to evaluate outcomes following outpatient surgery and patient-centered metrics to accurately assess effectiveness.
Patient-Centered Outcomes Several criteria should be considered when selecting appropriate outcome measures. The measure must be (1) clearly definable, (2) accurately and reliably measured, (3) important to the patient, and (4) lead to actionable process measures to improve care. In the setting of ambulatory surgery, traditional metrics of morbidity and mortality, such as urinary retention, postoperative bleeding, and inpatient admission, have met these criteria. As detailed previously, however, traditional outcome metrics have demonstrated few serious complications after ambulatory surgery, leading to few changes in care and a lack of ability to discern differences in varying interventions. Nevertheless, these outcome measures do represent a good start in the assessment of outcomes. To move forward in the area of quality assessment and outcomes analysis in ambulatory surgery, patient-centered outcomes may be of more value in distinguishing differences in interventions and identifying value of care to the individual patient. Patient-centered outcomes are classified as generic or disease-specific and are specifically designed to capture factors that influence outcome and define health from the patient perspective.22 Generic patient-centered outcomes are independent of the actual disease and consider overall impact of treatment on the patient.22 Disease-specific patient-centered outcomes evaluate symptoms or other characteristics that can be attributed to the presenting condition. The selection of clinically appropriate “outcomes” varies based on the question that we are asking; however, an assessment of both generic and disease-specific measures is ideal when evaluating the efficacy of treatment. In the area of ambulatory colorectal procedures, disease-specific patient-centered outcomes, such as continence and function, as well as more generic outcomes evaluating quality of life and patient satisfaction, may have more value to the patient when it is time for decision-making. After ambulatory colorectal surgery, disease-specific measures, such as fecal incontinence, pain, and bowel function, are likely to be of considerable value in assessing outcomes. One of the most valuable patient-centered metrics is fecal incontinence, which has been relatively overlooked by investigators despite its importance to patients. Scoring systems determine patient-reported incontinence severity and frequency through the Wexner incontinence score and the fecal incontinence quality-of-life score. Incontinence scoring has been used in prospective studies of hemorrhoidectomy23 and in the treatment of chronic anal fissures.24 A poor incontinence score is associated with a significant impairment of quality of life and can be particularly helpful in decisionmaking.25 Generic patient-centered outcomes include health-related quality of life, patient satisfaction, decision regret, and patient preference.22 A number of general and validated quality-
220 of-life questionnaires are available to assess health well-being before and following surgery. These surveys assess the patients’ overall physical, psychosocial, and general well-being. The Short Form Health Survey, Sickness Impact Profile, and the Nottingham Health Profile are commonly used generic patient-centered outcome measures. Despite the relative mainstreaming of these metrics in the medical literature, at this time few studies define health-related quality of life before or after ambulatory colorectal surgery procedures. There is a paucity of data evaluating quality of life in ambulatory colorectal surgery following anal fissure surgery. Data do reveal that minor incontinence has been associated with minor changes in quality of life before and after fissure therapy.26 Little detailed quality-of-life information is found in most other areas of ambulatory colorectal surgery. Patient satisfaction is a critical element of outcomes assessment but is rarely measured in ambulatory colorectal surgery. In 1 study of minor anorectal conditions treated in a day surgery setting, most patients found day surgery to be convenient and preferable to inpatient surgery.27 However, 11% of patients indicated that day surgery was inconvenient and would have preferred conventional inpatient surgery.27 These data may indicate that some patients lack the social support or medical understanding to complete their postoperative course at home. Thus, some patients may be best served with outpatient visiting nurse care or inpatient admission after particular interventions. Identification of those high-risk patients or high-risk procedures would be of considerable value to the clinician involved in ambulatory care. Despite the embryonic status of outcomes measurement in surgery, there have been some recent efforts to advance the field of patient-centered outcomes evaluation. Over the past 10 years, the Agency for Healthcare Research and Quality has funded and administered the Consumer Assessment of Healthcare Providers and Systems (CAHPS) program, a joint public and private initiative to develop standardized surveys of patients’ experiences with ambulatory and facility-level care.28 CAHPS surveys provide information about patients’ care experiences rather than traditional clinical performance indicators.28 Patients’ experiences, as measured by CAHPS surveys, thus provide complementary outcomes information to add to the traditional outcomes measures of cured of disease or morbidity and mortality. CAHPS surveys were originally developed to meet the need of consumers for usable, relevant information on quality of care from the patient’s perspective. However, they also play an important role as a quality improvement tool for health care organizations, which can use the standardized data to identify relative strengths and weaknesses in their performance, determine where they need to improve, and track their progress over time.28
Future Strategies Our hope with this review is to both summarize the data on ambulatory colorectal surgery outcomes and emphasize the critical need for more patient-centered outcomes assessment following these procedures. Given that approximately 60-
T. Francone and R. Ricciardi 70% of all surgical procedures are now performed in the outpatient setting, the time is right for more “patient-centered” measures of outcome. Although both complex and challenging because of the lack of standardized central databases, we are at an opportune time for this major shift in focus. Although there have been efforts to standardize preoperative, intraoperative, and postsurgical outcomes reporting;29,30 this effort has been hampered by the lack of uniformity and completeness in ambulatory records. Recent efforts to mainstream electronic medical records may help resolve some of the issues in organization and completeness. Our review is timely, given the focus on assessing quality in health care by physicians and other stakeholders. Nevertheless, a shift of focus to more patient-centered outcomes (ie, functional results, quality of life, or recurrence) following ambulatory surgery poses many challenges given our early stage of outcomes understanding. To carry us forward in this endeavor, we might start by asking our patients what is important to them and what their goals are for recovery. The long-term goals may be disease-specific; for example, goals and expectations are likely different for a patient with a chronic anal fistula compared with symptomatic hemorrhoidal disease. However, generic patient-centered metrics, such as patient satisfaction or quality of life, would also be meaningful to the clinician or patient who wishes to understand postoperative outcome before offering or choosing a particular procedure over alternative techniques or no intervention. In addition, the evaluation of long-term outcomes is also likely to be more pertinent to a population of patients whose conditions may not be lethal but may be associated with considerable suffering and disability. As addressed earlier, there is a clear need for researchers to identify important elements of traditional assessment metrics, as well as generic and disease-specific patient-centered outcomes following ambulatory surgery. The National Institutes of Health have initiated development of a national resource for accurate and efficient measurement of patientreported symptoms and other health outcomes in clinical practice.31 In addition, the Agency for Healthcare Research and Quality has also developed the Consumer Assessment of Healthcare Providers and Systems program to develop standardized patient surveys reflecting patient experiences with health care. These surveys provide information regarding ease of appointment scheduling, availability of information, communication with clinicians, responsiveness of clinic staff, and coordination between care providers.32 Data do support the theory that patient experiences correlate with clinical processes of disease management and with better health outcomes.33,34 The future of patient-centered outcomes became brighter on June 9, 2009, when President Obama signed into legislation the Patient Protection and Affordable Care Act, leading to the establishment of a private, nonprofit group, the Patient-Centered Outcomes Research Institute.35 Although this new institute conducts no research itself, the Patient-Centered Outcomes Research Institute funds comparative effectiveness research and generates evidence on the effectiveness of health care interventions and services. The Institute will
Measuring outcomes in ambulatory surgery form several internal advisory panels to set research priorities and oversee clinical trials.35 The effort includes a movement toward understanding the importance of, including the patients as a decision-maker, rather than a more paternalistic approach to medicine.
Conclusions In the USA, many strategies have been developed to improve inpatient care through the measurement and reporting of outcomes and quality data. Unfortunately, at this time, outcomes measurement following ambulatory surgery has been slow to develop and the traditional metrics used have failed to adequately measure that which is valued by the patient. Given that the number of outpatient procedures has increased substantially, there is a clear need for new metrics that address traditional outcomes as well as more patientcentered outcomes. To move forward in ambulatory surgery outcomes assessment, we first need to understand the critical components of ambulatory surgery care and identify outcomes that are truly valued by the patient. The addition of patient-centered outcomes with traditional disease-specific metrics will move us forward in the overall assessment of quality of care in ambulatory colorectal surgery.
References 1. Cullen KA, Hall MJ, Golosinskiy A: Ambulatory Surgery in the United States, 2006. Natl Health Stat Report 11:1-25, 2009 2. Detmer DE: Sounding board. Ambulatory surgery. N Engl J Med 305: 1406-1409, 1981 3. Hyman N, Simmang C, Simmang C, et al, The Standards Task Force, the American Society of Colon and Rectal Surgeons: Practice Parameters for Ambulatory anorectal Surgery. Dis Colon Rectum 46:573-576, 2003 4. Chung F, Mezei G: Adverse outcomes in ambulatory anesthesia. Can J Anaesth 46:R18-R34, 1999 5. Chung F, Mezei G, Tong D: Adverse events in ambulatory surgery. A comparison between elderly and younger patients. Can J Anaesth 46: 309-321, 1999 6. Hyman NH, Cataldo PA, Trevisani GT, et al: Tracking outcomes of anorectal surgery: The need for a disease-specific quality assessment tool. Dis Colon Rectum 51:1221-1224, 2008 7. Cobb WS, Heniford BT, Sigmon LB, et al: Colonoscopic perforations: Incidence, management, and outcomes. Am Surg 70:750-757, 2004 8. Consolo P, Luigiano C, Strangio G, et al: Efficacy, risk factors and complications of endoscopic polypectomy: Ten year experience at a single center. World J Gastroenterol 14:2364-2369, 2008 9. Fleisher LA, Pasternak LR, Lyles A: A novel index of elevated risk of inpatient hospital admission immediately following outpatient surgery. Arch Surg 142:263-268, 2007 10. Mezei G, Chung F: Return hospital visits and hospital readmissions after ambulatory surgery. Ann Surg 230:721-727, 1999 11. Misra T, Lalor E, Fedorak RN: Endoscopic perforation rates at a Canadian university teaching hospital. Can J Gastroenterol 18:221-226, 2004 12. Levin TR, Zhao W, Conell C, et al: Complications of colonoscopy in an integrated health care delivery system. Ann Intern Med 145:880-886, 2006
221 13. Pignone M, Rich M, Teutsch SM, et al: Screening for colorectal cancer in adults at average risk: A summary of the evidence for the U.S. Preventive Services Task Force. Ann Intern Med 137:132-141, 2002 14. Rex DK, Bond JH, Winawer S, et al: Quality in the technical performance of colonoscopy and the continuous quality improvement process for colonoscopy: Recommendations of the U.S. Multi-Society Task Force on Colorectal Cancer. Am J Gastroenterol 97:1296-1308, 2002 15. Davis JE, Detmer DE: The ambulatory surgical unit. Ann Surg 175:856862, 1972 16. Shnaider I, Chung F: Outcomes in day surgery. Curr Opin Anaesthesiol 19:622-629, 2006 17. Swan BA, Conway-Phillips R, Griffin KF: Demonstrating the value of the RN in ambulatory care. Nurs Econ 24:315-322, 2006 18. Coley KC, Williams BA, DaPos SV, et al: Retrospective evaluation of unanticipated admissions and readmissions after same day surgery and associated costs. J Clin Anesth 14:349-353, 2002 19. Duncan PG, Cohen MM, Tweed WA, et al: The Canadian four-centre study of anaesthetic outcomes: III. Are anaesthetic complications predictable in day surgical practice? Can J Anaesth 39:440-448, 1992 20. Osborne GA, Rudkin GE: Outcome after day-care surgery in a major teaching hospital. Anaesthesiol Intensive Care 21:822-827, 1993 21. Khuri SF, Daley J, Henderson W, et al: The Department of Veterans Affairs’ NSQIP: The first national, validated, outcome-based, risk-adjusted, and peer-controlled program for the measurement and enhancement of the quality of surgical care. National VA Surgical Quality Improvement Program. Ann Surg 228:491-507, 1998 22. Oliver A, Greenberg CC: Measuring outcomes in oncology treatment: The importance of patient-centered outcomes. Surg Clin North Am 89:17-25, 2009 23. Kanellos I, Angelopoulos S, Zacharakis E, et al: Stapled Haemorrhoidopexy for Haemorrhoids in Combination with Lateral Internal sphincterotomy for Fissure-in-Ano. Eur Surg Res 37:317-320, 2005 24. Arroyo A, Pérez F, Serrano P, et al: Surgical versus chemical (botulinum toxin) sphincterotomy for chronic anal fissure: Long-term results of a prospective randomized clinical and manometric study. Am J Surg 189:429-434, 2005 25. Rothbarth J, Bemelman WA, Meijerink WJ, et al: What is the impact of fecal incontinence on quality of life? Dis Colon Rectum 44:67-71, 2001 26. Nelson R: A systematic review of medical therapy for anal fissure. Dis Colon Rectum 47:422-431, 2004 27. Prasad J, Kyle SM, Isbister WH: Day case anorectal surgery. Aust NZ J Surg 62:866-870, 1992 28. Consumer Assessment of Healthcare Providers and Systems; Agency for Healthcare Research and Quality Available at: https://www. cahps.ahrq.gov/default.asp. 29. Lieberman D, Nadel M, Smith RA, et al: Standardized colonoscopy reporting and data system: Report of the Quality Assurance Task Group of the National Colorectal Cancer Roundtable. Gastrointest Endosc 65:757-766, 2007 30. Frezza EE, Girnys RP, Silich RJ, et al: Commentary: Quality of care and cost containment are the hospital-based ambulatory surgery challenges for the future. Am J Med Qual 15:114-118, 2000 31. National Institutes of Health: Patient-Reported Outcomes Measurement Information System Available at: http://www.nihpromis.org/ default.aspx. 32. Davies E, Shaller D, Edgman-Levitan S, et al: Evaluating the use of a modified CAHPS survey to support improvements in patient-centered care: Lessons from a quality improvement collaborative. Health Expect 11:160-176, 2008 33. Greenfield S, Kaplan S, Ware JE, Jr: Expanding patient involvement in care. Effects on patient outcomes. Ann Intern Med 102:520-528, 1985 34. Sequist TD, Schneider EC, Anastario M, et al: Quality monitoring of physicians: Linking patients’ experiences of care to clinical quality and outcomes. J Gen Intern Med 23:1784-1790, 2008 35. Center for Medical Technology Policy: Comparative Effectiveness Research Available at: http://www.cmtpnet.org/comparative-effectiveness.
A
ccording to the Centers for Disease Control and Prevention’s National Center for Health Statistics, the number of visits to freestanding ambulatory surgery centers increased about 300% from 1996 to 2006, whereas the rate of visits to hospital-based surgery centers remained largely unchanged during that time.1 A total of 57.1 million ambulatory procedures were performed as a component of 34.7 million patient visits in 2006.1 The list of ambulatory procedures has grown considerably spanning surgical and medical specialties, including endoscopy, lens extraction, and spinal canal injections.1 Colorectal procedures are particularly amenable to the ambulatory setting because of the volume of cases, minimally invasive techniques employed, and quick recovery. The most commonly used definition for ambulatory surgery includes those surgical interventions that are more complex than office-based procedures performed under local anesthesia but less complex than major procedures requiring at least an overnight stay.2 Today this definition has expanded to include a long list of short stay procedures that surgeons as well as other clinicians perform. Given the proposed advantages of ambulatory surgery, such as more rapid return to the comforts of a home environment, decreased potential for nosocomial complications, and diminished cost,3 these techniques have grown in acceptance. In addition, it is assumed that the number of ambulatory surgery procedures will continue to grow as new technologies convert inpatient cases to the outpatient setting.
*Department of Surgery, University of Rochester, Rochester, NY. †Department of Colon and Rectal Surgery, Lahey Clinic, Burlington, MA. ‡Tufts University, Boston, MA. Address reprint requests to: Rocco Ricciardi, MD, MPH, Department of Colon and Rectal Surgery, Lahey Clinic, 41 Mall Road, Burlington, MA 01805. E-mail: [email protected]
1043-1489/$-see front matter © 2011 Elsevier Inc. All rights reserved. doi:10.1053/j.scrs.2011.06.005
Given the increasing number of ambulatory surgical procedures, the assessment of outcomes has become more and more critical to assess and assure high-quality care. However, much of the current published literature focuses in on outcomes and quality of care at the inpatient level, evaluating more traditional outcomes, such as morbidity and mortality, or cost considerations. Nevertheless, it has become apparent that most colorectal procedures performed in an ambulatory setting have low rates of adverse events.4-8 Thus, surgeons and other interested stakeholders question whether traditional outcomes measures are pertinent to improving quality of care in the outpatient setting. Nontraditional outcomes, such as long-term complications, bowel and genitourinary function, quality of life, and other more patient-centered outcomes, may provide more suitable data needed to improve the quality of care in the outpatient setting. Although we know that colon and rectal surgeons perform an increasing number of anorectal and endoscopic procedures in ambulatory surgery centers, useful metrics for outcomes assessment are lacking in this arena. A review of the literature reveals few studies, lack of standardized definitions, and poor or inconsistent follow-up as contributing to the complexity and current lack of outcomes data in ambulatory surgery. In this review, we have summarized the data regarding outcomes assessment in ambulatory colon and rectal surgery, delineated the complexities of outcomes measurement, and suggested strategies for future work.
Present-Day Knowledge Much of the outcomes literature in the ambulatory care setting has come from small cases series and large administrative databases. Each type of database has strengths and weaknesses that limit generalizability while containing varying 217
218 levels of medical detail. Fleisher et al used outpatient surgical encounter data from the Agency for Healthcare Research and Quality (AHRQ) to report the rates of inpatient hospital admission and death rates following ambulatory surgery.9 AHRQ provided data based on New York State discharges with information on patient’s age, medical diagnosis, type of anesthesia, and procedure code. Over 783,539 patients were evaluated in the study. The study revealed that hospital admissions following outpatient surgery were low. Further analysis showed patients with extended operating time longer than 120 minutes, cardiovascular comorbidity diagnoses, malignancy, human immunodeficiency virus, and regional or general anesthesia were at higher risk of hospital admission.9 An outpatient surgery admission index was proposed as a guide to assist in identifying patients at a higher risk of immediate hospital admissions. Recognizing that clinical data were needed to evaluate outcomes in more detail, Mezei and Chung established a prospective database of preoperative, intraoperative, and postoperative data from a single ambulatory surgery center in Toronto.10 In this study of 17,638 consecutive patients, longterm follow-up was reported to adequately assess overall safety in a range of ambulatory surgery procedures. The authors reported intraoperative adverse events on standardized event sheets and postoperative follow-up was recorded at 30 days. Admissions following outpatient surgery were identified using the Canadian Institute of Health Information database. The authors reported an admission rate of 1.1% within 30 days and a complication-related readmission rate of 0.15%. Only 1 procedure was shown to predict inpatient admission from a long list of outpatient procedures, transurethral resection of bladder tumor.10 This study provided longer term follow-up data to help guide quality improvement strategies at the local and global level. In the area of ambulatory colon and rectal surgery, a large number of anorectal and endoscopic procedures are performed by colon and rectal surgeons as well as gastroenterologists and general surgeons. At this time, outcomes assessment in ambulatory colon and rectal surgery have focused on traditionally collected measures of morbidity and mortality, and a growing body of evidence evaluating costs. It should be of no surprise that most studies of ambulatory colorectal surgery identify few if any complications or postoperative sequelae.4-8 For example, in 1 study using a prospective quality tracking tool, investigators identified infrequent complications after common anorectal procedures, such as pilonidal cystectomy, hemorrhoidectomy, sphincterotomy, abscess drainage, and/or fistulotomy.6 In this study of over 900 index anorectal procedures, an overall complication rate of ⬍5% was noted with only 1 major complication related to the procedure.6 The authors also identified few minor complications, such as urinary retention, minor bleeding, wound infection, and urinary tract infection. Although the data are useful in documenting complications, when 1 considers these results in their context, an argument that traditional outcome metrics are of little importance in guiding clinical management can be made.
T. Francone and R. Ricciardi Similar to the findings with anorectal procedures, the incidence of complications following lower gastrointestinal endoscopy is also relatively low, despite serious complications, such as colonic perforation.7,8,11 Levin et al attempted to address the quality and magnitude of colonoscopy complications by identifying colonoscopy morbidity within 30 days from procedure. Of the 16,318 procedures identified by review of the Kaiser Permante integrated electronic medical record system, 183 complications were identified (1.1%).12 Similarly, in another study of 43,609 colonoscopies performed at the Carolinas Medical Center, 14 perforations (1 in 3115 procedures) were identified with few other complications.7 In addition to colonic perforations, immediate postpolypectomy bleed is relatively underreported, while data regarding delayed postpolypectomy bleed is absent.13 A study of 1354 polypectomies revealed procedural bleeding in 17 patients (1.3%), while 1 patient experienced perforation.8 These data reveal that endoscopic procedures are relatively safe with infrequent yet serious complications. There has been an effort to standardize colonoscopy reporting by the Quality Assurance Task Group of the National Colorectal Cancer Roundtable.14 This effort developed in response to the growing body of literature documenting variation in the quality of colonoscopy. The group developed key quality indicators for both reporting of procedures and the proper use of data generated by the system. Key data elements include preoperative (bowel preparation quality), intraoperative (cecal intubation rates, withdrawal times, adverse events), and postoperative procedural factors (hospitalization, complications, and documentation of follow-up).14 Basic auditing is then recommended to monitor quality and to identify specific elements for continuous quality improvement.
Cost Considerations Cost-effectiveness is an important consideration in the provision of medical care. While the determination of effectiveness following ambulatory surgery has been largely superficial, cost has been studied intensely. In addition to the cost of technology, the single greatest component of increased health care expenditures is in the cost of inpatient hospital care.15 Thus, a reduction in hospital charges of 25-50% has been described3 when an inpatient surgical procedure is transferred to the ambulatory setting. Nevertheless, there are data to suggest that although hospital costs are reduced with ambulatory procedures, much of this savings is due to shifting of costs to the patient and family in the form of home care.16 These data point to the importance of efforts to return patients to their preoperative functional level more quickly to reduce cost shifting from the hospital to the patient or family.17 An increased effort to transition many procedures to the ambulatory setting has led many to raise the concern for inpatient admission after outpatient surgery and its associated additional costs. Readmission and costs were evaluated in outpatients undergoing same day surgery in 1 retrospective study at an academic, tertiary-care institution. The au-
Measuring outcomes in ambulatory surgery thors found a higher than expected rate of inpatient admissions contributing substantially to overall costs, which they deemed both unnecessary and avoidable.18 Given these data, one can conclude that complications following ambulatory surgery are uncommon, and if inpatient admission is avoided, outpatient procedures can lead to cost savings for hospitals. It should be clear, however, that a firm grasp of cost-effectiveness requires a more detailed understanding of procedural effectiveness than is currently appreciated.
Difficulty in Assessment The current anorectal ambulatory surgery data are based on retrospective analyses or small prospective case-series leading to a limited knowledge base. Investigators interested in evaluating ambulatory surgery outcomes have encountered several difficulties. One of the greatest limitations in outcomes assessment for colorectal ambulatory procedures is requirement for minimal follow-up. Endoscopic procedures, such as screening colonoscopy, typically require no followup. Shortcomings in patient follow-up are due to the generally less complex nature of the operations performed in ambulatory surgery centers. This lack of follow-up is in sharp contrast with prospectively designed inpatient studies that report close follow-up. In addition, the interval of follow-up has also been variable with ambulatory surgery procedures varying from as little as 48-72 hours to several days.19,20 Given the poor follow-up, an assessment of readmission and complications is difficult following ambulatory surgery. Lack of validated datasets poses another limitation for those who wish to study outcomes in ambulatory surgery. The present-day surgical databases have been derived for inpatient investigations and are not well suited for answering specific questions pertaining to ambulatory surgery. These datasets that include ambulatory procedures are often incomplete and lack details regarding disease severity, comorbidity, and surgical indications. Critical medical information is often lacking or absent, adding to the relative doubt in validity of the conclusions. Given the difficulty identified with retrospective analyses of ambulatory surgery, a validated, risk-adjusted and complete data reporting mechanism is needed to evaluate outcomes following outpatient procedures. Unfortunately, maintaining a prospective database is labor-intensive, time-consuming, and very expensive. High volumes and lack of standardized data entry add to an already difficult task. A larger issue with outcome assessment in ambulatory surgery is the lack of standardized metrics, which are more commonly available in other settings (ie, American College of Surgeons National Surgical Quality Improvement Project).21 This dataset provides specific diagnoses as well as providing a defined period of follow-up. Most importantly, the National Surgical Quality Improvement Project provides validated metrics that have been developed to detect and characterize adverse events using a risk-adjusted, outcomes-based program.21 Unfortunately, in the area of ambulatory surgery, similar pertinent and validated metrics are lacking; optimal follow-up is not clear, and interest has been lacking. In the
219 future, data must be developed specifically to evaluate outcomes following outpatient surgery and patient-centered metrics to accurately assess effectiveness.
Patient-Centered Outcomes Several criteria should be considered when selecting appropriate outcome measures. The measure must be (1) clearly definable, (2) accurately and reliably measured, (3) important to the patient, and (4) lead to actionable process measures to improve care. In the setting of ambulatory surgery, traditional metrics of morbidity and mortality, such as urinary retention, postoperative bleeding, and inpatient admission, have met these criteria. As detailed previously, however, traditional outcome metrics have demonstrated few serious complications after ambulatory surgery, leading to few changes in care and a lack of ability to discern differences in varying interventions. Nevertheless, these outcome measures do represent a good start in the assessment of outcomes. To move forward in the area of quality assessment and outcomes analysis in ambulatory surgery, patient-centered outcomes may be of more value in distinguishing differences in interventions and identifying value of care to the individual patient. Patient-centered outcomes are classified as generic or disease-specific and are specifically designed to capture factors that influence outcome and define health from the patient perspective.22 Generic patient-centered outcomes are independent of the actual disease and consider overall impact of treatment on the patient.22 Disease-specific patient-centered outcomes evaluate symptoms or other characteristics that can be attributed to the presenting condition. The selection of clinically appropriate “outcomes” varies based on the question that we are asking; however, an assessment of both generic and disease-specific measures is ideal when evaluating the efficacy of treatment. In the area of ambulatory colorectal procedures, disease-specific patient-centered outcomes, such as continence and function, as well as more generic outcomes evaluating quality of life and patient satisfaction, may have more value to the patient when it is time for decision-making. After ambulatory colorectal surgery, disease-specific measures, such as fecal incontinence, pain, and bowel function, are likely to be of considerable value in assessing outcomes. One of the most valuable patient-centered metrics is fecal incontinence, which has been relatively overlooked by investigators despite its importance to patients. Scoring systems determine patient-reported incontinence severity and frequency through the Wexner incontinence score and the fecal incontinence quality-of-life score. Incontinence scoring has been used in prospective studies of hemorrhoidectomy23 and in the treatment of chronic anal fissures.24 A poor incontinence score is associated with a significant impairment of quality of life and can be particularly helpful in decisionmaking.25 Generic patient-centered outcomes include health-related quality of life, patient satisfaction, decision regret, and patient preference.22 A number of general and validated quality-
220 of-life questionnaires are available to assess health well-being before and following surgery. These surveys assess the patients’ overall physical, psychosocial, and general well-being. The Short Form Health Survey, Sickness Impact Profile, and the Nottingham Health Profile are commonly used generic patient-centered outcome measures. Despite the relative mainstreaming of these metrics in the medical literature, at this time few studies define health-related quality of life before or after ambulatory colorectal surgery procedures. There is a paucity of data evaluating quality of life in ambulatory colorectal surgery following anal fissure surgery. Data do reveal that minor incontinence has been associated with minor changes in quality of life before and after fissure therapy.26 Little detailed quality-of-life information is found in most other areas of ambulatory colorectal surgery. Patient satisfaction is a critical element of outcomes assessment but is rarely measured in ambulatory colorectal surgery. In 1 study of minor anorectal conditions treated in a day surgery setting, most patients found day surgery to be convenient and preferable to inpatient surgery.27 However, 11% of patients indicated that day surgery was inconvenient and would have preferred conventional inpatient surgery.27 These data may indicate that some patients lack the social support or medical understanding to complete their postoperative course at home. Thus, some patients may be best served with outpatient visiting nurse care or inpatient admission after particular interventions. Identification of those high-risk patients or high-risk procedures would be of considerable value to the clinician involved in ambulatory care. Despite the embryonic status of outcomes measurement in surgery, there have been some recent efforts to advance the field of patient-centered outcomes evaluation. Over the past 10 years, the Agency for Healthcare Research and Quality has funded and administered the Consumer Assessment of Healthcare Providers and Systems (CAHPS) program, a joint public and private initiative to develop standardized surveys of patients’ experiences with ambulatory and facility-level care.28 CAHPS surveys provide information about patients’ care experiences rather than traditional clinical performance indicators.28 Patients’ experiences, as measured by CAHPS surveys, thus provide complementary outcomes information to add to the traditional outcomes measures of cured of disease or morbidity and mortality. CAHPS surveys were originally developed to meet the need of consumers for usable, relevant information on quality of care from the patient’s perspective. However, they also play an important role as a quality improvement tool for health care organizations, which can use the standardized data to identify relative strengths and weaknesses in their performance, determine where they need to improve, and track their progress over time.28
Future Strategies Our hope with this review is to both summarize the data on ambulatory colorectal surgery outcomes and emphasize the critical need for more patient-centered outcomes assessment following these procedures. Given that approximately 60-
T. Francone and R. Ricciardi 70% of all surgical procedures are now performed in the outpatient setting, the time is right for more “patient-centered” measures of outcome. Although both complex and challenging because of the lack of standardized central databases, we are at an opportune time for this major shift in focus. Although there have been efforts to standardize preoperative, intraoperative, and postsurgical outcomes reporting;29,30 this effort has been hampered by the lack of uniformity and completeness in ambulatory records. Recent efforts to mainstream electronic medical records may help resolve some of the issues in organization and completeness. Our review is timely, given the focus on assessing quality in health care by physicians and other stakeholders. Nevertheless, a shift of focus to more patient-centered outcomes (ie, functional results, quality of life, or recurrence) following ambulatory surgery poses many challenges given our early stage of outcomes understanding. To carry us forward in this endeavor, we might start by asking our patients what is important to them and what their goals are for recovery. The long-term goals may be disease-specific; for example, goals and expectations are likely different for a patient with a chronic anal fistula compared with symptomatic hemorrhoidal disease. However, generic patient-centered metrics, such as patient satisfaction or quality of life, would also be meaningful to the clinician or patient who wishes to understand postoperative outcome before offering or choosing a particular procedure over alternative techniques or no intervention. In addition, the evaluation of long-term outcomes is also likely to be more pertinent to a population of patients whose conditions may not be lethal but may be associated with considerable suffering and disability. As addressed earlier, there is a clear need for researchers to identify important elements of traditional assessment metrics, as well as generic and disease-specific patient-centered outcomes following ambulatory surgery. The National Institutes of Health have initiated development of a national resource for accurate and efficient measurement of patientreported symptoms and other health outcomes in clinical practice.31 In addition, the Agency for Healthcare Research and Quality has also developed the Consumer Assessment of Healthcare Providers and Systems program to develop standardized patient surveys reflecting patient experiences with health care. These surveys provide information regarding ease of appointment scheduling, availability of information, communication with clinicians, responsiveness of clinic staff, and coordination between care providers.32 Data do support the theory that patient experiences correlate with clinical processes of disease management and with better health outcomes.33,34 The future of patient-centered outcomes became brighter on June 9, 2009, when President Obama signed into legislation the Patient Protection and Affordable Care Act, leading to the establishment of a private, nonprofit group, the Patient-Centered Outcomes Research Institute.35 Although this new institute conducts no research itself, the Patient-Centered Outcomes Research Institute funds comparative effectiveness research and generates evidence on the effectiveness of health care interventions and services. The Institute will
Measuring outcomes in ambulatory surgery form several internal advisory panels to set research priorities and oversee clinical trials.35 The effort includes a movement toward understanding the importance of, including the patients as a decision-maker, rather than a more paternalistic approach to medicine.
Conclusions In the USA, many strategies have been developed to improve inpatient care through the measurement and reporting of outcomes and quality data. Unfortunately, at this time, outcomes measurement following ambulatory surgery has been slow to develop and the traditional metrics used have failed to adequately measure that which is valued by the patient. Given that the number of outpatient procedures has increased substantially, there is a clear need for new metrics that address traditional outcomes as well as more patientcentered outcomes. To move forward in ambulatory surgery outcomes assessment, we first need to understand the critical components of ambulatory surgery care and identify outcomes that are truly valued by the patient. The addition of patient-centered outcomes with traditional disease-specific metrics will move us forward in the overall assessment of quality of care in ambulatory colorectal surgery.
References 1. Cullen KA, Hall MJ, Golosinskiy A: Ambulatory Surgery in the United States, 2006. Natl Health Stat Report 11:1-25, 2009 2. Detmer DE: Sounding board. Ambulatory surgery. N Engl J Med 305: 1406-1409, 1981 3. Hyman N, Simmang C, Simmang C, et al, The Standards Task Force, the American Society of Colon and Rectal Surgeons: Practice Parameters for Ambulatory anorectal Surgery. Dis Colon Rectum 46:573-576, 2003 4. Chung F, Mezei G: Adverse outcomes in ambulatory anesthesia. Can J Anaesth 46:R18-R34, 1999 5. Chung F, Mezei G, Tong D: Adverse events in ambulatory surgery. A comparison between elderly and younger patients. Can J Anaesth 46: 309-321, 1999 6. Hyman NH, Cataldo PA, Trevisani GT, et al: Tracking outcomes of anorectal surgery: The need for a disease-specific quality assessment tool. Dis Colon Rectum 51:1221-1224, 2008 7. Cobb WS, Heniford BT, Sigmon LB, et al: Colonoscopic perforations: Incidence, management, and outcomes. Am Surg 70:750-757, 2004 8. Consolo P, Luigiano C, Strangio G, et al: Efficacy, risk factors and complications of endoscopic polypectomy: Ten year experience at a single center. World J Gastroenterol 14:2364-2369, 2008 9. Fleisher LA, Pasternak LR, Lyles A: A novel index of elevated risk of inpatient hospital admission immediately following outpatient surgery. Arch Surg 142:263-268, 2007 10. Mezei G, Chung F: Return hospital visits and hospital readmissions after ambulatory surgery. Ann Surg 230:721-727, 1999 11. Misra T, Lalor E, Fedorak RN: Endoscopic perforation rates at a Canadian university teaching hospital. Can J Gastroenterol 18:221-226, 2004 12. Levin TR, Zhao W, Conell C, et al: Complications of colonoscopy in an integrated health care delivery system. Ann Intern Med 145:880-886, 2006
221 13. Pignone M, Rich M, Teutsch SM, et al: Screening for colorectal cancer in adults at average risk: A summary of the evidence for the U.S. Preventive Services Task Force. Ann Intern Med 137:132-141, 2002 14. Rex DK, Bond JH, Winawer S, et al: Quality in the technical performance of colonoscopy and the continuous quality improvement process for colonoscopy: Recommendations of the U.S. Multi-Society Task Force on Colorectal Cancer. Am J Gastroenterol 97:1296-1308, 2002 15. Davis JE, Detmer DE: The ambulatory surgical unit. Ann Surg 175:856862, 1972 16. Shnaider I, Chung F: Outcomes in day surgery. Curr Opin Anaesthesiol 19:622-629, 2006 17. Swan BA, Conway-Phillips R, Griffin KF: Demonstrating the value of the RN in ambulatory care. Nurs Econ 24:315-322, 2006 18. Coley KC, Williams BA, DaPos SV, et al: Retrospective evaluation of unanticipated admissions and readmissions after same day surgery and associated costs. J Clin Anesth 14:349-353, 2002 19. Duncan PG, Cohen MM, Tweed WA, et al: The Canadian four-centre study of anaesthetic outcomes: III. Are anaesthetic complications predictable in day surgical practice? Can J Anaesth 39:440-448, 1992 20. Osborne GA, Rudkin GE: Outcome after day-care surgery in a major teaching hospital. Anaesthesiol Intensive Care 21:822-827, 1993 21. Khuri SF, Daley J, Henderson W, et al: The Department of Veterans Affairs’ NSQIP: The first national, validated, outcome-based, risk-adjusted, and peer-controlled program for the measurement and enhancement of the quality of surgical care. National VA Surgical Quality Improvement Program. Ann Surg 228:491-507, 1998 22. Oliver A, Greenberg CC: Measuring outcomes in oncology treatment: The importance of patient-centered outcomes. Surg Clin North Am 89:17-25, 2009 23. Kanellos I, Angelopoulos S, Zacharakis E, et al: Stapled Haemorrhoidopexy for Haemorrhoids in Combination with Lateral Internal sphincterotomy for Fissure-in-Ano. Eur Surg Res 37:317-320, 2005 24. Arroyo A, Pérez F, Serrano P, et al: Surgical versus chemical (botulinum toxin) sphincterotomy for chronic anal fissure: Long-term results of a prospective randomized clinical and manometric study. Am J Surg 189:429-434, 2005 25. Rothbarth J, Bemelman WA, Meijerink WJ, et al: What is the impact of fecal incontinence on quality of life? Dis Colon Rectum 44:67-71, 2001 26. Nelson R: A systematic review of medical therapy for anal fissure. Dis Colon Rectum 47:422-431, 2004 27. Prasad J, Kyle SM, Isbister WH: Day case anorectal surgery. Aust NZ J Surg 62:866-870, 1992 28. Consumer Assessment of Healthcare Providers and Systems; Agency for Healthcare Research and Quality Available at: https://www. cahps.ahrq.gov/default.asp. 29. Lieberman D, Nadel M, Smith RA, et al: Standardized colonoscopy reporting and data system: Report of the Quality Assurance Task Group of the National Colorectal Cancer Roundtable. Gastrointest Endosc 65:757-766, 2007 30. Frezza EE, Girnys RP, Silich RJ, et al: Commentary: Quality of care and cost containment are the hospital-based ambulatory surgery challenges for the future. Am J Med Qual 15:114-118, 2000 31. National Institutes of Health: Patient-Reported Outcomes Measurement Information System Available at: http://www.nihpromis.org/ default.aspx. 32. Davies E, Shaller D, Edgman-Levitan S, et al: Evaluating the use of a modified CAHPS survey to support improvements in patient-centered care: Lessons from a quality improvement collaborative. Health Expect 11:160-176, 2008 33. Greenfield S, Kaplan S, Ware JE, Jr: Expanding patient involvement in care. Effects on patient outcomes. Ann Intern Med 102:520-528, 1985 34. Sequist TD, Schneider EC, Anastario M, et al: Quality monitoring of physicians: Linking patients’ experiences of care to clinical quality and outcomes. J Gen Intern Med 23:1784-1790, 2008 35. Center for Medical Technology Policy: Comparative Effectiveness Research Available at: http://www.cmtpnet.org/comparative-effectiveness.