Clinical Guidelines, Defensive Medicine, and the Physician Between the Two Asaf Toker, MD,*† Shifra Shvarts, PhD,* Zvi H. Perry, BMed,* Yariv Doron, MD,† and Haim Reuveni, MD*† Purpose: In this article, we study the use of the American Academy of Otolaryngology–Head and Neck Surgery recommendations regarding coagulation screening tests before tonsillectomy and adenoidectomy by ear, nose, and throat (ENT) physicians in Israel and offer insights into the reasons for accepting/declining this recommendation. Materials and Methods: During April and May 2002, 309 self-administered questionnaires were sent to all ENT physician members of the Israeli Society of Otolaryngology–Head and Neck Surgery. Physicians answered questions regarding demographic data, their habits of preoperative laboratory and imaging tests before tonsillectomy and adenoidectomy, and the reasons for performing these tests. Results: One hundred ninety-six (63.4% compliance rate) physicians responded to the survey. One hundred fifty-four (78.6% of the responding physicians) do not follow guideline recommendations and ask their otherwise healthy patients to undergo prothrombin time/ partial thromboplastin time (PT/PTT) tests before tonsillectomy and adenoidectomy. Common practice in their departments was the leading reasoning for preoperative PT/PTT testing for 101 (51.5%) physicians. Eighty-nine physicians (45.4%) specifically stated that the reason for this behavior is defensive medicine, thirty-two physicians (16.3%) stated that the reason for those tests is hospital requirements, and literature recommendation was the reason in 24 (12.2%), followed by personal experience for 11 physicians (5.6%). Conclusions: Most ENT physicians in Israel do not follow clinical guidelines and perform unnecessary coagulation tests before tonsillectomy and adenoidectomy. More studies are needed to find ways to change physicians’ behavior regarding preoperative tests. (Am J Otolaryngol 2004;25:245-250. © 2004 Elsevier Inc. All rights reserved.)
Defensive use of diagnostic tests in order to avoid malpractice suits is common behavior of physicians worldwide.1,2 Defensive medicine is defined as a physician’s deviation from what is considered to be good practice to prevent complaints from patients or their families. In 1999, the American Academy of Otolaryngology–Head and Neck Surgery recommended that coagulation screening tests for healthy children before tonsillectomy and adenoidectomy (T&A) are warranted only for patients whose medical history or current
From the *Department of Health Systems Management, Ben-Gurion University of the Negev, Beer-Sheva, Israel; and †Soroka University Medical Center, BeerSheva, Israel. Address correspondence to Asaf Toker, MD, Soroka University Medical Center, Pediatric Division, BeerSheva 84101, Israel. E-mail:
[email protected] © 2004 Elsevier Inc. All rights reserved. 0196-0709/$ - see front matter doi:10.1016/j.amjoto.2004.02.002
physical examination indicated coagulation problems.3 T&A are the most common elective surgeries among children in the United States.4 The majority of children undergoing elective T&A are generally healthy, but postoperative bleeding occurs in 2% to 4% of cases.5 Since 1999, the American Academy of Otolaryngology– Head and Neck Surgery has recommended performing a coagulation screening test only for those patients whose medical history or physical examination may indicate coagulation problems.3 In contrast to this recommendation, physicians continue to perform coagulation screening tests before T&A surgery,6 even though no correlation has been found between normal or abnormal preoperative coagulation tests and bleeding tendency during and after T&A surgery. As a result of this last study, one HMO in Israel (Clalit Health Care Services, the largest HMO in Israel) adopted these recommendations by publishing a guideline letter to all its ear, nose, and throat (ENT) surgeons and med-
American Journal of Otolaryngology, Vol 25, No 4 (July-August), 2004: pp 245-250
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ical directors stating that “pre-operative coagulation tests in otherwise healthy children undergoing T&A are not warranted and therefore should not be performed.” The Israeli Society of Otolaryngology–Head and Neck Surgery has not yet published any guidelines regarding this issue. In this research, we describe Israeli ENT physicians’ practice regarding their habits and reasons for performing or not performing preoperative coagulation tests before T&A surgery in healthy children.
study since because no longer perform T&As. One hundred sixty (83.3%) of the physicians were men. One hundred fifty-one of 185 (81.6%) were board-certified ENT specialists, and 34 of 185 (18.4%) were residents in the last 2 years of their residency program before their national board examinations. Ninety-one of 179 (50.8%) of the responding ENTs are on salary, working in hospitals, whereas 49 (27.4%) work in the community (salary fee per patient) and 39 (21.8%) are working in the community and in the hospital. The average years experience as an ENT specialist was 15.9 (range 0-46 years). One hundred eight of 192 (56.2%) studied in Israel, 46 (24%) in Western Europe and North America, 34 (17.7%) completed their training in Eastern European countries, and 4 (2.1%) graduated elsewhere and then retrained and board certified in Israel.
METHODS A descriptive study was conducted during April and May 2002. After the approval of chairman of the Israeli Society of Otolaryngology–Head and Neck Surgery, 309 self-administered questionnaires were sent by mail to all physicians that are members of this society. This study population includes residents and board-certified ENT physicians operating in Israel. The self-administered questionnaire (Appendix 1) was reviewed and validated by 3 ENTs. These 3 physicians did not participate in the survey. The questionnaire contained 3 parts: physician personal and demographic details, preoperative workup, and reasons for performing coagulation tests before T&A. Confidentiality was maintained by numbering the names of the physicians in the questionnaires. In cases in which no answer was received, a second questionnaire was sent by mail 2 months later to increase the response rate. The data were collected and analyzed using SPSS 11 software (SPSS Inc, Chicago, IL) and analyzed by descriptive statistics such as mean and standard deviation and then analyzed by using Student t test.
Preoperative Workup One hundred fifty-four of 194 physicians (79.4%) asked their patients to undergo prothrombin time/partial thromboplastin time (PT/PTT) tests before T&A (Table 2). One hundred sixty-nine of 194 (87.1%) requested a complete blood count, 26 of 194 (13.4%) asked for bleeding time results, 8 of 194 (4.1%) asked for a chest radiograph, and 4 of 194 (2.1%) asked for an electrocardiograph. Only 4 of 194 physicians (2.1%) did not ask for any preoperative tests before T&A. Reasons for Preoperative Testing
RESULTS Common practice in their departments was the leading reasoning for preoperative PT/ PTT testing in 101 of 194 physicians (52.1%); 89 of 194 (45.9%) physicians specifically
Study population (Table 1) included 196 of 309 physicians (63.4% compliance rate). Two retired physicians were excluded from the TABLE 1. Study Population (n ⫽ 194)* Gender (n ⫽ 192)
Personal Stage (n ⫽ 185)
M
F
ENT Specialists
160 (83.3%)
32 (16.7%)
151 (81.6%)
Major Work Place (n ⫽ 179)
Resident
H
C
H&C
34 (18.4%)
91 (50.8%)
49 (27.4%)
39 (21.8%)
Years Since Boards 15.9 years (0-46)
Country of Medical School (n ⫽ 192) Israel
OECD Countries
Eastern European
108 (56.3%)
46 (24%)
34 (17.7%)
*Totals can be less than 194 since not all physicians answered all demographic questions.
CLINICAL GUIDELINES AND DEFENSIVE MEDICINE
TABLE 2. Pre-Operative Laboratory and Imaging Test
Test Study Population ⫽ 194* Complete blood count (CBC) PT/PTT Bleeding time (BT) Chest X-ray Electrocardiograph (ECG) Other tests No tests
Number of Physicians Who Ask for this Test
Number of Physicians Who Do Not Ask for this Test
169 (87.1%)
25 (12.9%)
154 (79.4%) 26 (13.4%) 8 (4.1%) 4 (2.1%) 9 (4.6%) 4 (2.1%)
40 (20.6%) 168 (86.6%) 186 (95.9%) 190 (97.9%) 185 (95.4%) 185 (97.9%)
*Totals exceed 194 as more than one response was possible for each question.
stated that the reason for performing unnecessary preoperative tests is defensive medicine (Table 3). Thirty-two (16.5%) physicians stated that the reason for those tests is hospital policy. Literature recommendations were the reason in 24 of 194 (12.5%) followed by personal experience 11 of 194 physicians (5.7%). When comparing ordering habit and reasons for preoperative PT/PTT for different professional status, gender, work place, and country of medical studies, we found no statistical significances between the groups. Years in practice influences the type of test requested before T&A. Older physicians (25.78 years) asked for more (P ⬍ .001) bleeding time tests before T&A than younger physicians (14.29 years). In contrast, younger physicians (15.09 years) asked for more (P ⬍ .05) Complete blood counts before surgery than older physicians (21.48 years). DISCUSSION Two thirds of the ENT physicians in Israel participated in the study. This group is similar to the profile of all ENT surgeons practicing in the country: most are well-experienced (15.9 years) male specialists, trained in Israel, and working in a hospital as well as in community settings. Eighty percent of these doctors did not comply with clinical practice guideline (CPG) recommendations by reporting that they perform unnecessary blood coagulation tests in otherwise healthy children before T&A.
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Clinical Guidelines CPGs are systematically developed statements that assist practitioner and patient decisions about appropriate health care in specific clinical circumstances.7 Such a tool, when built on knowledge, experience, and evaluations by an expert board, may set the point of standard of care for practicing good medicine and creating standardization of care in the overall treatment. CPGs may influence physicians’ behavior,8 guiding them through evidence-based information to a consensus of an optimal treatment strategy. Among the noteworthy reasons given by physicians for lack of adherence to clinical practice guidelines are a lack of awareness of, familiarity with, and agreement with the guidelines9,10; continuing previous practice habits9; avidity for using new drugs11; and the strong influence of pharmaceutical company representatives.12 All ENT surgeons practicing in the health care arena in Israel are expected to follow guideline recommendations when managing patients in the preoperative stage before T&A. CPGs for T&A in children clearly state that once the patient’s history and physical examination turn out to be flawless, additional blood coagulation tests would yield nothing in the vast majority of the cases, thus creating unnecessary burdens to the child and his family, as well as to the economy of the health care system. Deviations from the CPG recommendations were found to have 2 leading causes: common practice in the department (52.1%) and practicing defensive medicine (45.9%). TABLE 3. Reasons for Requesting Pre-Operative Coagulation Tests in Healthy Children Before T&A Reason Study Population ⫽ 194*
Number of Physicians Who Answered Yes
Number of Physicians Who Answered No
Hospital policy Common practice in my department Defensive medicine Professional literature Personal experience Other reasons
32 (16.5%) 101 (52.1%)
162 (83.5%) 93 (47.9%)
89 (45.9%) 24 (12.5%) 11 (5.7%) 12 (6.2%)
105 (54.1%) 170 (87.5%) 183 (94.3%) 182 (93.8%)
*Totals exceed 194 as more than one response was possible for each question.
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Defensive medicine is described as “a clear deviation from the doctor’s usual behavior or from what is considered to be good practice, in order to prevent complaints or criticism by the patient.”1 Or in other words, “You’ll never get sued for doing too much. You’ll get nailed for doing too little. . .”13 The fear of law suits is explained by the head of the American College of Internal Medicine, saying “Society has an enormous appetite for health care, but little willingness to accept very low probability for adverse outcomes. . .”13 Departmental habits are usually based on individual/collective preferences and experience, including the habits of practicing defensive medicine because of the increase in number of lawsuits in the past. Thus, defensive behavior is embedded in the departmental habitual practice of medicine, creating an economic burden to the health care system because of the rise in medical insurance premiums accordingly. Specialists in general, and ENT physicians in particular, when facing the risk of being sued for every action they make, protect themselves by taking extraprotective measures and partially ignore the CPG recommendations (ie, performing blood coagulation tests before a T&A). When multiplying the number of T&As done each year by the cost of a single PT/PTT test, a substantial cost emerges because of these extra measures. In today’s reality, facing the never-ending demand for efficiency, these tests erode the limited resources of the health care systems worldwide. In late 1998, an Australian committee set several recommendations14 regarding the process of establishing CPG acceptance and legal status. A CPG must not be declared as legally binding, thus allowing the physician to keep his autonomy in cases that demand special considerations. Nevertheless, the legal status of CPG should be defined (should it be a Hearsay status v an Expert-witness’s status). A wellestablished ratification board of experts should be set up to be used as a senior approval board for CPGs. Endorsement of a CPG by such a board may add weight to the evidentiary value of the CPG in the court of law. This board will also set quality standards for CPG approval and updating procedures, therefore serving as proof of quality once its authorization was given to a CPG. Once the
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physician chooses to deviate from an established CPG, he/she should clearly document the circumstances for doing so. Thus, he/she preserves the standard of care and minimizes the chances of being sued in the court of law. In the United States, when charges were made in cases in which the physician followed an accepted CPG,13 25% of the cases were dropped before they even reached the courtroom because the lawyers refused to take the cases in the first place. Of those cases that reached the court room, in about one third, guidelines played an important role in the case, 22% were solved solely based on the CPG (ie, by presenting the accepted CPG to the judge without any further debate), and 27% used the CPG to reach settlements. Not following CPG recommendations is not unique only for unnecessary coagulation blood tests before a T&A.15 No single action can change a physician’s behavior toward greater adherence with a CPG.9,16,17 Only a process that creates a supportive environment (both legal and professional) for the practicing physician will alleviate the threatening burden of being sued, allowing a physician to practice in a better and less defensive mode. To achieve this goal, the HMOs, Ministry of Health, and expert physicians have to define local and consensus CPGs and embed them in the health care system.18 Furthermore, they need to determine and promote the legal status of CPGs in the court of law; promote educational activities, reminder systems, and performance feedback to physicians18; and update systems, all of which may improve medical practice.19-21 The cost-effectiveness outcome of these activities to support physicians’ practice environment needs further studies. CONCLUSION Old practice habits of ENT surgeons in Israel, as well as practicing defensive medicine, are the main causes of not following CPG recommendations and performing unnecessary blood coagulation tests in otherwise healthy children before T&A. Further studies are needed to explore the best way to change physician habits to better comply with Guideline recommendations.
CLINICAL GUIDELINES AND DEFENSIVE MEDICINE
APPENDIX 1: THE QUESTIONNAIRE
Dear Colleagues, Following the debate that developed around the issue of “Pre-operative coagulation tests in otherwise healthy children undergoing elective T&A,” we have received the approval of the Chairman of the Israeli Society for Otolaryngology–Head and Neck Surgery to conduct a survey regarding your views of preoperative tests and reasons for performing coagulation tests in healthy children undergoing T&A. The results of this survey will be forwarded to the society and will help establish policy regarding this issue. The questionnaire is anonymous. WE THANK YOU FOR YOUR COOPERATION! A. Physician personal and demographic details 1. Professional stage: Board certified/ Prior to board exam (step B)/Prior to Board exam (Step A) 2. Major work place (more than 50%): community/hospital/hospital & community 3. Years after boards: ____________ 4. In what country did you study medicine? _____________ 5. If you studied in Israel, which medical school? Tel Aviv/Jerusalem/ Haifa/Beer-Sheva 6. Gender: Male/Female B. Preoperative workup 1. Indicate laboratory and imaging tests that you usually request otherwise healthy children to perform prior to elective T&A. a. PT/PTT b. Bleeding time c. CBC d. ECG e. Chest X-ray f. Other __________ g. No tests
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C. Preoperative workup reasoning 1. If you perform coagulation tests (PT/ PTT) before T&A, please specify your reason(s) for those tests: a. This is hospital policy b. Professional literature c. This is the common practice in my department d. Defensive medicine e. Personal experience f. Other reasons: ______________ ACKNOWLEDGMENT The authors wish to thank Miss Lina Kanterovich for her valuable contribution to this paper. REFERENCES 1. Van Boven K, Dijksterhuis P, Lamberts H: Defensive testing in Dutch family practice. Is the grass greener on the other side of the ocean? J Fam Pract 44:468-472, 1997 2. Summerton N: Positive and negative factors in defensive medicine: A questionnaire study of general practitioners. BMJ 310:27-29, 1995 3. American Academy of Otolaryngology–Head and Neck Surgery: Clinical Indicators Compendium. Alexandria, VA, American Academy of Otolaryngology–Head and Neck Surgery Inc, 1999 4. Derkay CS: Pediatric otolaryngology procedures in the United States: 1977-1987. Int J Pediatr Otorhinolaryngol 24:1-12, 1993 5. Bolger WE, Parsons DS, Potempa L: Preoperative hemostatic assessment of the adenotonsillectomy patient. Otolaryngol Head Neck Surg 103:396-405, 1990 6. Toker A, Reuveni H, Yermiahu T, et al: The need for routine pre-operative coagulation screening tests (prothrombin time PT/partial thromboplastin time PTT) for healthy children undergoing elective tonsillectomy and/or adenoidectomy. Int J Pediatr Otorhinolaryngol 61: 217-222, 2001 7. Hyams AL, Brandenburg JA, Lipsitz SR, et al: Practice guidelines and malpractice litigation: A two-way street. Ann Intern Med 122:450-455, 1995 8. Vail Z. “Defensive Medicine”—Defensive approach or operative approach? Israeli Medical Association (Letter to Members). February 2000, pp 43-44 9. Cabana MD, Rand CS, Powe NR, et al: Why don’t physicians follow clinical practice guidelines? A framework for improvement. JAMA 282:1458-1465, 1999 10. Lomas J, Anderson GM, Domnick-Pierre K, et al: Do practice guidelines guide practice? The effect of a consensus statement on the practice of physicians. N Engl J Med 321:1306-1311, 1989 11. James PA, Cowan TM, Graham RP, et al: Family physicians’ attitudes about and use of clinical practice guidelines. J Fam Pract 45:341-347, 1997 12. Jones MI, Greenfield SM, Bradley CP: Prescribing new drugs: Qualitative study of influences on consultants and general practitioners. BMJ 323:378-381, 2001 13. Crane M: Managed Care 1999. Clinical guidelines: A malpractice safety net? Med Econ 76:236-243, 1999
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14. Pelly JE, Newby L, Tito F, et al: Clinical practice guidelines before the law: Sword or shield? Med J Aust 169:330-333, 1998 15. Crim C: Clinical practice guidelines vs actual clinical practice: The asthma paradigm. Chest 118:62S-64S, 2000 (suppl 2) 16. Greco PJ, Eisenberg JM: Changing physicians’ practices. N Engl J Med 329:1271-1273, 1993 17. Putnam W, Burge F, Tatemichi S, et al: Asthma in primary care: Making guidelines work. Can Respir J 8:29A-34A, 2001 (suppl A) 18. Israeli A, Peterburg I: Clinical guidelines and their implications [Hebrew]. Harefuha 141:362-363, 2002
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19. Weingarten SR, Henning JM, Badamgarav E, et al: Interventions used in disease management programmes for patients with chronic illness—Which ones work? Meta-analysis for published reports. BMJ 325:925-942, 2002 20. Thomson O’Brien MA, Freemantle N, et al. Continuing medical education and workshops: Effects of professional practice and health care outcomes. In The Cochrane Library [CD-ROM]. Oxford, Update Software Ltd., 2002 21. Demakis JG, Beauchamp C, Cull WL, et al: Improving residence’ compliance with standards of ambulatory care: Results from the VA Cooperative Study on Computerized Reminders. JAMA 284:1411-1416, 2000