Preoperative Testing for Urethral Sling Surgery for Stress Urinary Incontinence: Overuse, Underuse and Cost Implications Tom S. Feng,* Colby E. Perkins,* Lauren N. Wood,* Karyn S. Eilber,† Jerome K. Wang,* Catherine Bresee* and Jennifer T. Anger*,‡ From the Division of Urology (TSF, LNW, KSE, JTA) and Department of Internal Medicine (JKW), Cedars-Sinai Medical Center, David Geffen School of Medicine at UCLA (CEP), and Cedars-Sinai Biostatistics & Bioinformatics Research Center (CB), Los Angeles, California
Abbreviations and Acronyms AAFP ¼ American Academy of Family Physicians BMP ¼ basic metabolic panel CBC ¼ complete blood count CXR ¼ chest x-ray ECG ¼ electrocardiogram FPMRS ¼ Female Pelvic Medicine and Reconstructive Surgery MUS ¼ mid urethral sling NSQIP ¼ National Surgical Quality Improvement Program UA ¼ urinalysis
Purpose: We identify areas of overuse and underuse in the preoperative evaluation of patients undergoing mid urethral sling surgery. We also estimate the effect of overuse of preoperative testing on health care costs. Materials and Methods: We conducted a retrospective review of women who underwent sling surgery with or without concomitant prolapse repair between 2012 and 2013. Physician orders for preoperative electrocardiogram, chest x-ray, basic metabolic panel, complete blood count, coagulation studies and urinalysis were classified as appropriate or inappropriate based on summary guidelines from the American Academy of Family Physicians. The additional costs of inappropriate tests were estimated using the 2014 Medicare clinical laboratory and physician fee schedules. Results: A total of 101 women who underwent mid urethral sling surgery were identified and 346 preoperative tests were ordered. Overall 76% of coagulation profiles, 73% of complete blood counts, 47% of basic metabolic panels, 39% of chest x-rays and 21% of electrocardiograms ordered did not have an appropriate clinical indication. In addition, 6% of electrocardiograms, 22% of chest x-rays and 10% of urinalyses were not ordered despite an appropriate indication. The estimated charges of overused tests were $1,844.15 for the cohort, or $18 per patient. Conclusions: Preoperative testing is overused as well as underused in patients undergoing sling surgery. The greatest variation occurred with the use of electrocardiograms, chest x-rays and urinalysis. Poor adherence to national guidelines leads to increased health care costs and warrants increased awareness in following evidence-based guidelines. Key Words: preoperative period, suburethral slings, health care costs Accepted for publication August 5, 2015. The corresponding author certifies that, when applicable, a statement(s) has been included in the manuscript documenting institutional review board, ethics committee or ethical review board study approval; principles of Helsinki Declaration were followed in lieu of formal ethics committee approval; institutional animal care and use committee approval; all human subjects provided written informed consent with guarantees of confidentiality; IRB approved protocol number; animal approved project number. * No direct or indirect commercial incentive associated with publishing this article. † Financial interest and/or other relationship with American Medical Systems and Boston Scientific. ‡ Correspondence: Cedars-Sinai Medical Center, Department of Surgery, Division of Urology, 99 N. La Cienega Blvd., Suite 307, Beverly Hills, California 90211 (telephone: 310-385-2992; FAX: 310-385-2973).
Editor’s Note: This article is the fifth of 5 published in this issue for which category 1 CME credits can be earned. Instructions for obtaining credits are given with the questions on pages 232 and 233.
0022-5347/16/1951-0120/0 THE JOURNAL OF UROLOGY® Ó 2016 by AMERICAN UROLOGICAL ASSOCIATION EDUCATION AND RESEARCH, INC.
http://dx.doi.org/10.1016/j.juro.2015.07.110 Vol. 195, 120-124, January 2016 Printed in U.S.A.
PREOPERATIVE TESTING PATTERNS FOR SLING SURGERY
PHYSICIANS use a range of preoperative tests to evaluate patient health status and anesthetic risk before surgery. Considering the significant cost of preoperative testing and the poor correlation of preoperative testing with patient outcomes,1,2 efforts have been made to make preoperative testing more targeted to appropriate patient populations undergoing specific types of procedures.3 To support this effort several professional societies have published risk based guidelines and algorithms to assist providers in identifying appropriate preoperative tests for at risk patient populations and procedures.3 Despite these guidelines, significant variability remains among providers ordering these tests.1,4 Evaluation of the adherence to evidence-based recommendations has been published in the general surgery literature and that of surgical subspecialties, including plastic, ophthalmologic and gynecologic surgery.5e8 However, to date there is a paucity of evidence addressing adherence to preoperative testing guidelines in Female Pelvic Medicine and Reconstructive Surgery. Specifically we sought to identify areas of overuse and underuse in the preoperative evaluation of patients undergoing MUS surgery with or without concomitant prolapse repair. The impact of preoperative testing on health care costs was also evaluated.
history and medication list were reviewed to determine whether a preoperative test was ordered with or without clinical indication. The appendixes show the recommendations from the source guidelines that the AAFP evaluated from numerous specialty societies, including the American College of Cardiology/American Heart Association, American Society of Anesthesiologists, Institute for Clinical Systems Improvement, American College of Physicians, and American College of Radiology. For simplicity, international guidelines in the AAFP article were not included as part of this evaluation. If the preoperative tests ordered by a physician were consistent with any 1 of the national clinical guidelines listed in the appendixes of the AAFP article, then that particular provider was considered guideline adherent. A summary of the guidelines used in this study is provided in the supplementary Appendix (http://jurology.com/). To explore the economic impact of preoperative testing, cost estimates were performed using the California Medicare Administrative Contractor billing prices from the Medicare clinical laboratory fee schedule and Medicare physician fee schedule for calendar year 2014.9 The relevant Healthcare Common Procedure Coding System and CPT codes were identified for the laboratory studies, procedures and imaging, as was their interpretation. These codes were then used to identify the associated Medicare and institutional prices. For CXR and ECG the cost of interpretation was included in the analysis. For each test requiring a blood draw the cost of venipuncture was also included. However, if a patient underwent 2 blood tests, such as a BMP and CBC, the cost of venipuncture was only counted once.
MATERIALS AND METHODS The institutional review board approved this retrospective chart review of women who underwent MUS surgery with or without concomitant prolapse repair between May 2012 and May 2013. All cases were performed by FPMRS faculty at Cedars-Sinai Medical Center and identified using CPT code 57288 (sling operation for stress incontinence: fascia or synthetic). Demographic data (patient age, race, comorbidities) and type of procedure were recorded. Physician orders (included orders by internal medicine providers and surgeons) for preoperative electrocardiograms, chest x-rays, basic metabolic panels, complete blood counts, coagulation profiles and urinalyses were abstracted from medical records by 2 investigators. The initial 10 patient charts were reviewed by both researchers and were then compared to ensure inter-rater reliability in the data abstraction. Patients who were tested for any component of a grouping of tests, ie prothrombin time but not partial thromboplastin time, were classified as having undergone that group of tests. Each of the previously mentioned tests and procedures was classified as appropriate or inappropriate based on guidelines from multiple specialty societies compiled by the American Academy of Family Physicians.3 The purpose of the AAFP article, published in March 2013, was to evaluate and synthesize existing clinical guidelines into a brief and user-friendly set of recommendations for preoperative evaluation of patients undergoing noncardiac surgery. Each patient’s active problem list, medical
RESULTS A total of 101 women who underwent MUS surgery were identified and of these women 57 had concomitant prolapse repair. Patient demographics are shown in table 1. A total of 346 preoperative tests were ordered. The most frequently ordered tests were UA, conducted for 97% of patients, ECG for 63%, CBC for 63%, BMP for 59% and coagulation profiles for 41%. Of all patients 62% had at least 1 nonindicated test, and 133 tests ordered (38%) were not guideline based. Only 24% of coagulation profiles and 27% of CBCs ordered were clinically indicated based on guidelines (table 2). In addition, 47% of BMPs, 39% of CXRs and 21% of ECGs ordered did not meet guideline criteria. There were 6 UAs that were duplicate orders, and 3 ECGs, 4 CXRs and 10 UAs were not ordered when indicated. All ECGs and CRXs were ordered by medical internists or cardiologists from preoperative consultation visits. All UAs were ordered by surgeons. Medical internists ordered 88% of BMPs, 87% of CBCs and 93% of coagulation profiles, while surgeons ordered 12% of BMPs, 13% of CBCs and 7% of coagulation profiles. The estimated charges of the overused tests to the health care system are $1,844
PREOPERATIVE TESTING PATTERNS FOR SLING SURGERY
Table 1. Patient demographics
Table 3. Cost estimates of nonguideline based preoperative testing No.
Age: Less than 40 40e65 Greater than 65 Race: Caucasian African-American Hispanic Other Procedure: MUS only MUS þ anterior/posterior colporrhaphy MUS þ robotic sacrocolpopexy MUS þ vaginal hysterectomy Comorbidities: Heart disease Peripheral vascular disease Cerebrovascular disease Hypertension Obesity Hyperlipidemia Smoker Diabetes Asthma/chronic obstructive pulmonary disease Liver disease Kidney disease Hematologic disorder Anemia
6 58 37 71 2 21 7 38 48 9 6 16 2 3 28 12 21 18 13 13 5 4 3 15
by Medicare reimbursement rates, with most of the costs accrued from excessive CXRs, CBCs, coagulation studies and ECGs (table 3).
DISCUSSION Historically, adult preoperative evaluation included a history and physical examination, accompanied by laboratory studies, imaging, electrocardiography and cardiopulmonary evaluation, often without regard to risk factors.3 Proper preoperative evaluation allows for the assessment of preexisting conditions as well as new medical conditions with the goal of minimizing perioperative risk.3,10 Despite the potential clinical impact made by preoperative testing, multiple studies have suggested that much of preoperative testing obtained is not clinically Table 2. Adherence to guideline based testing No. Tests Overall ECG CXR BMP CBC UA Coagulation profiles Totals
63 23 59 63 97 41 346
No./Total No. Underuse (%)* 3/53 4/18 0 0 10/101 0
No. Appropriate Use (%)
(5.7) (22) (0) (0) (9.9) (0)
50 (79.4) 14 (60.9) 31 (52.5) 17 (27) 97 (100)‡ 10 (24.4) 219
* Number of indicated tests that were not ordered. † Number of tests ordered that were not indicated. ‡ Six UAs were duplicate orders.
No. Overuse (%)† 13 9 28 46 0 31
(20.6) (39.1) (47.5) (73) (0) (75.6)
ECG CXR BMP CBC UA Coagulation profile Venipuncture
No. Tests Overused
2014 Medicare Fees Los Angeles, CA
13 9 28 46 6 31 28
$18.52 $26.77 $11.54 $10.61 $7.82 $13.56 $3.00
Total Medicare fees
Estimated Medicare Cost $240.76 $240.93 $323.12 $488.06 $46.92 $420.36 $84.00 $1,844.15
indicated.1,5e7,11 Our findings demonstrate that adherence to national guidelines on preoperative testing in low risk FPMRS cases is poor. In our study a significant number of patients had tests performed that were not guideline compliant. We demonstrated that 62% of patients had at least 1 test ordered that was not guideline based, a finding similar to other reports. A population based analysis using the American College of Surgeons NSQIP database examined patterns of preoperative testing in patients undergoing elective hernia repair, and showed that 54% of patients had at least 1 test despite no clear indication for testing.5 A similar study using NSQIP data found that 59% of patients undergoing ambulatory plastic surgery had preoperative testing without clear indications.6 Poor adherence to evidence-based recommendations on preoperative testing is also reflected in a large retrospective study of more than 1,400 women undergoing gynecologic surgery.7 The authors found that 90% of women had at least 1 nonindicated preoperative test whereas 5% did not undergo the recommended testing. While the authors reported a similar rate of CBCs being appropriately obtained (29%), they reported higher rates of inappropriate testing for ECGs, CXRs and coagulation profiles. Furthermore, it has been demonstrated that neither testing nor abnormal results are associated with postoperative outcomes. The NSQIP analysis of more than 5,300 cases of plastic surgery revealed no association between abnormal laboratory testing and postoperative complications (p¼0.178).6 Another analysis of 2,000 elective surgical cases showed that 60% of routinely ordered tests were performed without clinical indication and only 0.22% of these test results were abnormal.2 The authors also showed that these few abnormal tests did not change management nor did they lead to adverse surgical or anesthetic events. In addition, a randomized, controlled trial comparing 9,408 patients who did not have any preoperative testing to 9,411 who had testing showed no difference in the overall rates of complications, intraoperative or
PREOPERATIVE TESTING PATTERNS FOR SLING SURGERY
postoperative, after cataract surgery.8 These data suggest that eliminating routine medical testing for low risk ambulatory surgery does not compromise patient safety and that the tests may not be necessary. However, our 10% rate of missed UA does pose a potential infectious risk to patients undergoing MUS procedures. The 4 CXRs that were considered underused were for patients with a clear history of chronic obstructive pulmonary disease/asthma, but none of these patients had an intraoperative or postoperative complication. In addition, the overuse of preoperative testing in women undergoing sling surgery has led to an increased economic burden. Based on Medicare fees the estimated cost of the overused tests to the health care system was $1,844 for the cohort, or $18 per patient. While the cost of individual tests may be low, the aggregate costs can be substantial. The estimated cost of preoperative testing is $3 billion annually in the United States,12,13 and the number of annual ambulatory surgery procedures, including MUS for stress urinary incontinence, is increasing. The number of mid urethral sling surgeries performed in 2007 was estimated to be 71,180, which equates to an estimated cost of approximately $1.3 million for the noncompliant preoperative tests ordered.14 In addition to decreasing costs, increased awareness and better adherence to national guidelines may lead to better quality of care. For instance, avoiding excessive venipuncture could preclude unnecessary discomfort. In our study 28% of patients would have been spared from unnecessary venipuncture. Moreover, one has to consider patient discomfort and anxiety related to falsepositive or abnormal but clinically insignificant test results, and the subsequent followup diagnostic tests and procedures. Given this heavy financial and clinical burden, several strategies have been developed to improve adherence to national guidelines. In an observational study Barazzoni et al reported a 57% reduction in the number of CXRs ordered and a 43% reduction in ECGs after the implementation of institution based practice guidelines to reduce the number of inappropriate tests.15 The reductions in preoperative tests ordered corresponded to a cost savings of $42,000 during the first 2 years after implementation of the new guidelines and more than $650,000 if extrapolated to include all ambulatory surgery cases during that period. Similarly, in a review of patterns of preoperative testing by orthopedic surgeons and a medical consultant, the establishment of new hospital guidelines decreased the number of tests ordered from a mean of 8.0 to 5.6 in 2 years (p <0.001).16 In addition, preoperative evaluation clinics have also been shown to improve the appropriate use of
preoperative tests and to reduce cancellations or delay of surgeries, thereby reducing health care costs and improving the quality of patient care.17e19 In our study the majority of preoperative tests were ordered by internists. This is not surprising, given that most patients had preoperative clearance consultations by their internists. Surgeons were responsible for a small fraction of the tests, except in the case of UA, which is under the direct purview of the surgeon. Therefore, the implementation of preoperative evaluation clinics under the supervision of anesthesiologists may improve adherence to testing guidelines and reduce rates of overuse. To our knowledge, this study is the first to evaluate patterns of preoperative testing for MUS surgeries. We demonstrate that even with relatively low risk FPMRS procedures there is significant overuse of preoperative tests. We based our study on the appendixes from the American Academy of Family Physicians summary guidelines and recognize that adherence rates differ based on the guidelines chosen. However, the summary appendixes were chosen because they were some of the most comprehensive and would bias the results toward more appropriate ordering of tests. For instance, if a patient’s condition met at least 1 of the guideline criteria for obtaining an ECG, it was documented as appropriate use of this preoperative test. We do acknowledge that the guidelines use nondirective wording such as “usually appropriate,” “may be considered” or “may be recommended” and, therefore, accurate assessment of the overuse and underuse of testing can be difficult. Our use of more lenient inclusion criteria may explain the lower percentage of patients found to have a nonguideline based test performed compared to the gynecologic literature, which used the National Institute for Health and Clinical Excellence guidelines.7 We acknowledge that current national guidelines on preoperative testing are merely recommendations, and not based on high quality evidence with assessments of the risks and burdens of noncompliant testing. Furthermore, these guidelines do not take into account individual patient characteristics from the history and physical examination that may warrant testing. We recognize that several limitations exist in our current study. We analyzed the use of preoperative testing before a MUS procedure, which did not account for any surgeries that were cancelled based on missing or abnormal tests in our retrospective analysis. However, when this study was conducted no cases were cancelled due to clinically significant abnormal preoperative testing. Thus, while we did not specifically study the impact of abnormal preoperative testing on patient outcomes and adverse
PREOPERATIVE TESTING PATTERNS FOR SLING SURGERY
events, we can infer that abnormal test results were uncommon and rarely affected surgical management. Another limitation is the possibility of incomplete data capture that may confound the underuse rates of preoperative testing reported in our study. Moreover our cost analysis was based on the California state Medicare reimbursement fee schedules. As costs vary widely from region to region, we acknowledge the economic costs of preoperative testing may vary significantly. Finally, this is a retrospective study based at a single institution and may not be representative of regional/national practice patterns. Nevertheless, we achieved our goal of providing a descriptive analysis of the patterns of preoperative testing and
the impact on health care costs. We recognize that our current study is limited by sample size and that a study powered to detect the impact of nonadherence to preoperative testing guidelines would be of value.
CONCLUSIONS Preoperative testing is overused as well as underused in patients undergoing sling surgery, with the greatest variation occurring with the use of ECGs, CXRs and UA. Poor adherence to national guidelines leads to increased health care costs and warrants the awareness of health care providers in following evidence-based guidelines.
REFERENCES 1. Bryson GL, Wyand A and Bragg PR: Preoperative testing is inconsistent with published guidelines and rarely changes management. Can J Anaesth 2006; 53: 236.
7. St Clair CM, Shah M, Diver EJ et al: Adherence to evidence-based guidelines for preoperative testing in women undergoing gynecologic surgery. Obstet Gynecol 2010; 116: 694.
2. Kaplan EB, Sheiner LB, Boeckmann AJ et al: The usefulness of preoperative laboratory screening. JAMA 1985; 253: 3576.
8. Schein OD, Katz J, Bass EB et al: The value of routine preoperative medical testing before cataract surgery. Study of Medical Testing for Cataract Surgery. N Engl J Med 2000; 342: 168.
3. Feely MA, Collins CS, Daniels PR et al: Preoperative testing before noncardiac surgery: guidelines and recommendations. Am Fam Physician 2013; 87: 414.
9. Centers for Medicare & Medicaid Services: Medicare Clinical Laboratory Fee Schedule and Medicare Physician Fee Schedule, 2014. Available at www.cms.gov.
4. Bass EB, Steinberg EP, Luthra R et al: Do ophthalmologists, anesthesiologists, and internists agree about preoperative testing in healthy patients undergoing cataract surgery? Arch Ophthalmol 1995; 113: 1248.
10. Kumar A and Srivastava U: Role of routine laboratory investigations in preoperative evaluation. J Anaesthesiol Clin Pharmacol 2011; 27: 174.
5. Benarroch-Gampel J, Sheffield KM, Duncan CB et al: Preoperative laboratory testing in patients undergoing elective, low-risk ambulatory surgery. Ann Surg 2012; 256: 518. 6. Fischer JP, Shang EK, Nelson JA et al: Patterns of preoperative laboratory testing in patients undergoing outpatient plastic surgery procedures. Aesthet Surg J 2014; 34: 133.
11. Garcia AP, Pastorio KA, Nunes RL et al: Indication of preoperative tests according to clinical criteria: need for supervision. Braz J Anesthesiol 2014; 64: 54. 12. Richman DC: Ambulatory surgery: how much testing do we need? Anesthesiol Clin 2010; 28: 185. 13. Fischer SP: Cost-effective preoperative evaluation and testing. Chest 1999; 115: 96S.
14. Wu JM, Gandhi MP, Shah AD et al: Trends in inpatient urinary incontinence surgery in the USA, 1998-2007. Int Urogynecol J 2011; 22: 1437. 15. Barazzoni F, Grilli R, Amicosante AM et al: Impact of end user involvement in implementing guidelines on routine pre-operative tests. Int J Qual Health Care 2002; 14: 321. 16. Mancuso CA: Impact of new guidelines on physicians’ ordering of preoperative tests. J Gen Intern Med 1999; 14: 166. 17. Lemmens LC, Kerkkamp HE, van Klei WA et al: Implementation of outpatient preoperative evaluation clinics: facilitating and limiting factors. Br J Anaesth 2008; 100: 645. 18. Ferschl MB, Tung A, Sweitzer B et al: Preoperative clinic visits reduce operating room cancellations and delays. Anesthesiology 2005; 103: 855. 19. Fischer SP: Development and effectiveness of an anesthesia preoperative evaluation clinic in a teaching hospital. Anesthesiology 1996; 85: 196.