THESIS HURS 1998 H647u c.2. _ Hill, Michael P. Utilization of clinical guidelines far 1998. Utilization of Clinical Guidelines for Laboratory Evaluation of Suspected Gallbladder or Pancreatic Pathology By Michael P. Hill Submitted in Partial Fulfillment of the Requirements for the Masters of Science in Nursing Degree Approved by: Judjfth Schilling, PhD, CRNP Committee Chairperson Edinboro University of Pennsylvania tertkieisel, PhD, RN mmittee Member dinboro University of Pennsylvania Ellen Pfadt, MSN, RN Committee Member Edinboro University of Pennsylvania Date Date Date Utilization of Clinical Guidelines for Laboratory Evaluation of Suspected Gallbladder or Pancreatic Pathology The purpose of this study was to evaluate whether emergency health care practitioners utilize diagnostic laboratory testing consistent with the guidelines promulgated by the American College of Emergency Physicians (ACEP). In 1994, the Clinical Policy for the Initial Approach to Patients Presenting With a Chief Complaint of Nontraumatic Acute Abdominal Pain was approved by the ACEP board. This policy statement provided suggested guidelines for the diagnostic work-up and treatment for patients presenting with acute abdominal pain. The utilization of established medical protocols for diagnostic testing is closely aligned to the general practice of family nurse practitioners (Murphy, 1997). This non-experimental, retrospective study involved the review of emergency department medical charts for adult patients with a discharge diagnosis related to cholelithiasis, cholecystitis, and/ or pancreatitis. Permission from the medical center nursing research approval committee was obtained prior to the initiation of data collection. Fifty charts were reviewed comparing the laboratory diagnostic evaluation of this sample with the established ACEP guidelines. This study found that diagnostic testing was consistent with the ACEP guide for gallbladder disease 70% of the time and 77% of the time for pancreatic disease, when excluding the requirement for serum calcium for the pancreatic evaluation. Strict adherence to the pancreatic policy produced an outcome of only 12% compliance with recommended testing. ii Acknowledgments First, I would like to thank Dr. Schilling for her editing, assistance and support as chairperson of my thesis committee. Next, I need to thank the other members of my committee, Dr. Geisel and Ms. Pfadt, for their assistance and input for this project. I thank my wife, Cathy, and my children, Aaron and Caitlin, for their patience and support throughout the time required for me to complete this study. iii Table of Contents Content Page Abstract ii Acknowledgments iii List of Tables Vll Chapter I. Introduction 1 Statement of the Research Problem 2 Theoretical Framework 2 Research Question Assumptions Definitions of Terms 4 Limitations 6 Summary 6 Chapter IL Review of the Literature Clinical Guidelines 8 Defensive Medicine 9 Cost Containment. 10 Objections to Guideline Use ACEP Guidelines Liver Function Tests . Complete Blood Count iv Amylase and Lipase 14 Other Laboratory Testing 15 Summary 15 Chapter III. Methodology 16 Hypothesis 16 Operational Definitions 16 Research Design 17 Procedures and Sample 17 Informed Consent 18 Data Analysis 18 Summary 18 Chapter IV. Results 19 Demographics 19 Gallbladder Disease Testing 21 Pancreatic Disease Testing Summary Chapter V. Discussion.... Summary Conclusions Recommendations References v Appendixes 36 A. ACEP Clinical Policy 36 B. Causes for Abnormal Liver Enzymes 37 C. Gallbladder Disease Data Sheet 39 D. Pancreatic Disease Data Sheet .40 vi List of Tables Table Page 1. Demographic Data .20 2. Liver Testing for Gallbladder Disease 22 3. Diagnostic Imaging for Gallbladder Disease .23 4. Liver Enzyme Testing for Pancreatic Disease 24 5. Diagnostic Imaging for Pancreatic Disease 25 vii 1 Chapter 1 Introduction The major concepts affecting reform of health care practices are access to care, quality, and cost (Buerhaus, 1996). Within the current managed care environment, medical care continues to be analyzed to insure that quality care is provided as cost effectively as possible. There are multiple reasons for the inflated costs of medical care today (Buerhaus, 1996). The practice of defensive medicine contributes significantly to higher costs. In 1989, American Medical Association (AMA) statisticians estimated that $15.1 billion was spent on physician-ordered defensive medicine (McCormick, 1993). Excessive laboratory diagnostic testing has been identified as a contributor to the high cost of defensive medical practice (Robinson, 1994). Standarized practice guidelines, also known as critical or clinical pathways, have been developed to help lower costs, improve quality, and standardize care (Adelman, 1996). They help to control costs by standardizing ordering practices and eliminating excesses in treatment. In addition to standardizing practice, adherence to such guidelines may also add an additional defense in medical malpractice situations (Costello & Murphy, 1995). Health care providers, such as nurse practitioners, are often held accountable to established practice guidelines when being evaluated for patient problems related to medical malpractice (Murphy, 1997). It is estimated that 5% to 10% of all emergency department visits are associated with the complaint of abdominal pain (American College of Emergency 2 Medicine, 1994). Many of those complaints are clinically related to the disease processes of the biliary and pancreatic organs. Some estimates indicate that 20 million people in the United States ha'ive gallstones (Rakel, 1996). The American College of Emergency Medicine (ACEP) established clinical policies for the evaluation of patients presenting with nontraumatic acute abdominal pain in 1994 (Appendix A). The intent of these guidelines was to improve patient care outcomes. These policy statements were afforded as general guides for the diagnostic work-up and treatment of these conditions. Adoptions of such guides for general practice may aid in controlling medical cost and potential liability while maintaining quality patient care practices (Adelman, 1996). Statement of the Research Problem It is not known whether emergency department health care practitioners follow established practice guidelines when evaluating patients with the suspected gallbladder (biliary) or pancreatic abdominal pain complaints. Are their diagnostic laboratory ordering practices consistent with the ACEP guidelines for evaluation of non-traumatic abdominal pain? Theoretical Framework Hesook Suzie Kim (1983) described a theoretical framework addressing “collaborative decision making in nursing practice” (p. 271). Her model described the relationship between the nurse and the patient involved in decisions related to healthcare practices. Kim also discussed seven essential elements of a collaborative decision making process. These are (a) elient, (b) nurse, (c) organization, (d) decision 3 type, (e) level of collaboration in decision making, (f) nature of the decision, and (g) client outcomes. Current literature looks to collaborative practice as a desirable model for nurse practitioners and physicians in the primary care setting (Arcangelo, Fitzgerald, Carroll, & Plumb, 1996). Collaboration involves a joint decision making process addressing the wellness and illness needs of the patient. Collaborative practice has been identified as interchange between the physician and the nurse practitioner to meet the needs of patients within the shared practice. Each medical practitioner makes a contribution based on his or her own level of expertise (Arcangelo, et al., 1996). The decision type central to this paper is what Dr. Kim (1983) termed “operational control decisions”. She defined these as decisions that require selecting particular action depending on the specific situation. When operational control decisions are involved, there are usually required actions and immediate choices. Organizational structures that may influence operational control decisions can be an ing established practice guidelines, the nurse existing system of protocols. In using practitioner may address the issues of defensive medicine, while maintaining quality healthcare and controlling costs. The last concept of the framework is related to patient outcomes (Kim, 1983). The level of collaboration and nature of decisions are primary outcomes of the process. The patient outcomes related to the mutually expected goal of treatment or testing. The expected patient outcome for the purposes of this paper is related to the 4 correlation between following established practice guidelines and making the correct diagnosis of gallbladder or pancreatic pathology. Research Question The purpose of this study was to answer the following question. How frequently do emergency department practitioners follow the Clinical Policyfor the Initial Approach to Patients Presenting With a Chief Complaint ofNontraumatic Acute Abdominal Pain established by the American College of Emergency Physicians (ACEP, 1994) when evaluating patients with suspected biliary or pancreatic abdominal pain? Assumptions This study was based on the following assumptions: 1. Adult patients in this study presenting with complaints consistent with biliary or pancreatic type abdominal pain were a representative sample of persons with these complaints. 2. Health care practitioners working in emergency services are knowledgeable about the ACEP clinical policy statement promulgated in 1994 that addresses the initial approach to patients presenting with a chief complaint of nontraumatic acute abdominal pain. 3. Health care practitioners are likely to follow consistent ordering practices when making a diagnosis of gallbladder and/or pancreatic disease. Definition of Terms The following terms are defined as they were used in this study: 5 1. Bihary pertains to the structures conveying bile; specifically, biliary ducts conveying bile from the liver to the hepatic ducts (Thomas, 1973). Biliary pain usually refers to the presence of symptoms and pathology associated with inflammation of the gallbladder (Andreoli, Bennett, Carpenter, & Plum, 1997). 2. Gallbladder refers to the pear-shaped saccular organ under the surface of the right lobe of the liver that contains bile until it is discharged via the cystic duct (Thomas, 1973). 3. Cholecystitis refers to the inflammation of the gallbladder (Thomas, 1973). 4. Cholelithiasis describes the formation or presence of calculi or bilestones in the gallbladder or common bile duct (Thomas, 1973). 5. Clinical practice guidelines attempt to translate common medical knowledge into decisions and algorithms for diagnosis and treatment of specific medical problems (Biscof & Nash, 1996). 6. Defensive medicine is referred to as care that does not benefit the patient, and is provided solely to avoid malpractice (Costello & Murphy, (1995). 7. Cost effectiveness refers to the economic analysis of the benefits or outcomes of a healthcare intervention (Biscof & Nash, 1996) 8. Hepatic pertains to the liver. 9. Case management is a systematic approach used to identify high-cost patient activities and opportunities to coordinate care while controlling costs and improving outcomes (Crummer & Carter, 1993). 6 10. Managed care is viewed as a cost effective approach to quality patient care. Some components of managed care may include case management plans, critical pathways, case consultation, and healthcare team meetings (Martich, 1993). 11. Murphy’s sign occurs when palpation of the epigastrium and right upper abdominal quadiant elicits marked tenderness, and an inspired breath is arrested (Rakel, 1996). 12. Pancreatitis pertains to an inflammatory condition of the pancreas (Thomas, 1973). Limitations The following limitations of this study were identified: 1. This study setting has medical practitioners with 35 or more years experience, as well as those who recently completed their residency programs. 2. The emergency physicians’ practices being evaluated may not be the same as a nurse practitioners’ in similar situations, although all health care practitioners are expected to operate under similar accountabilities (Buchanan, 1996). 3. This was a convenience sample of adult patients presenting to one emergency facility in northwest Pennsylvania with 35,000 total annual visits. Study data was collected over one 3 to 4 month time period. Summary Clinical practice guidelines have been gaining wider acceptance to control cost and insure quality outcomes (Costello & Moiphy, Diagnostic guidelines serve to direct medical practitioners through a chronological pathway of standard 7 testing and theiapy for patients with specific complaints (Crummer & Carter, 1993). Adherence to such guidelines may also provide protection in terms of liability when concerns about appropriateness of care are raised (Costello & Murphy, 1995). The use of the American College of Emergency Physicians clinical policy for evaluating adults with nontraumatic abdominal pain (1994) parallels Dr. Kim’s (1983) description of operational control decisions that may require the use of standard protocols. The use of such standards is being promoted to standardize practice as well as lower medical costs (Adelman, 1996). Nurse practitioners assessing clients with biliary or pancreatic problems may be evaluated by the same practice guidelines. The outcome of this study may identify opportunities for education related to the use of ACEP clinical guidelines for evaluation of patients with nontraumatic acute abdominal pain. 8 Chapter II Review of the Literature This chapter reviews the literature associated with using clinical guidelines for patient assessment. The primary issues considered are the general recommendations for use of clinical guidelines, the practice of defensive medicine, and cost containment. Also, a review of the laboratory testing related to the American College of Emergency Physicians (1994) diagnostic work-up for biliary and pancreatic disease is addressed. Clinical Guidelines Along with standardizing practice, clinical pathways or guidelines have been established to help lower costs (Adelman, 1996). Guidelines are generally established by expert opinion and provide the most effective and appropriate standard of care based on current knowledge (Murphy, 1997). Murphy wrote that using practice guidelines helps ensure that the practitioner is providing the patient with the best possible level of care. One strength of nationally recognized clinical practice guidelines is that they are supported by scientific evidence and rely less on tradition or intuition (Dracup, 1996). In a systematic review of research that involved the effect of clinical guidelines on patient care, Grimshaw and Russell (1993) found consistent evidence that their use improved medical practice. They performed a meta-analysis of 59 randomized trials that met scientific criteria for validity. Twenty-four trials investigated guidelines for specific clinical conditions, twenty-seven studied preventive care, and eight looked at guidelines for prescribing or for support services. 9 AU but four of these studies delected sigmficant improvements in the process pf care after introduction of clinical guidelines. The Agencyfor Health Care Policy and Research (AHCPR, 1997), a part of the Public Health Service in the U.S. Department of Health and Human Services, was established in December of 1989. The agency’s purpose was to review research-based information with the goal of improving the quality of care, reducing associated cost, and improving access to essential services. AHCPR staff work with the medical community to develop a national database of clinical practice guidelines. Currently, clinical practice guidelines have been published for common, treatable conditions. Defensive Medicine. One study evaluated the practice of defensive medicine among family practitioners in the Netherlands (Boven, Dijksterhuis, & Lamberts, 1997). These researchers defined defensive medicine as “clear deviation from the family physician’s usual behavior and from what is considered to be good practice in order to prevent complaints or criticism by the patient or the patient’s family” (p.468). They reviewed the practices of 16 family physicians and recorded 8897 episodes of care that required laboratory testing, diagnostic imaging, or both. They found that defensive medicine was associated with 27% of all tests ordered. The results of this study can be translated to the current primary care environment in the United States. A study by Boven et al. (1997) concluded that defensive testing is associated with a lower probability of finding abnormal results. They advised that medical practitioners use other measures to protect themselves 10 from malpractice rather than the excessive laboratory testing associated with defensive medicine. Clinical practice guidelines establish the most effective and appropriate standard of care based on current scientific evidence (Murphy, 1997). In medical malpractice cases, a relevant issue is whether the practitioner met the established standard of caie. Costello and Murphy (1995) wrote that malpractice cases usually question whethei adequate care was provided. That provision of care relates to national standards comparing similar cases. From a liability perspective, medical practitioners adhering to the established guidelines would be more protected than would those deviating from them (Murphy, 1997). Cost Containment. In 1992 an estimated $800 billion was spent on U.S. healthcare (Robinson, 1994). Costs of providing medical care are increasing annually at a rate of approximately 15%. Robinson also related that clinicians have control of up to 80% of these costs. Laboratory costs account for nearly 10% of the overall cost, and in 1985 that number exceeded $30 billion. The cost of operating laboratories has increased faster than the general inflation rate due to many factors (Starland & Brzys, 1990). Some of the increase in volume of testing is directly related to the advances in technology. Other factors contributing to increased volume of testing are easier access, liability concerns, and the increased disease acuity of our aging population. Practitioners’ increased utilization of laboratory services may be a result of insufficient knowledge of test Il characteristics, and reliance on technology rather than using clinical judgment for diagnosis of a clinical condition (Robinson, 1994). Cost control measures are aimed at decreasing the 20% to 95% excessive ordering piactices that are part of common diagnostic evaluations. Axt-Adam, Van Der Wouden, and Van Der Does (1993) published a literature review related to the behavior of physicians ordering laboratory tests. Some studies demonstrated a positive correlation between the use of laboratory test ordering guidelines and a reduction in laboratory utilization (1993). Another related study demonstrated a decrease in the number of tests ordered simply by showing the associated cost on the computer screen which was used for ordering (Tierney, Miller, & McDonald, 1990). This resulted in 14% fewer tests with an associated 13% reduction in charges. Another study demonstrated similar results utilizing a multidisciplinary approach. Directors of various inpatient units, information systems, laboratory, radiology, pharmacy, and nursing initiated a comprehensive cost-reduction program concentrating on laboratory and radiologic testing, blood products, nutritional and drug therapies (Barie & Hydo, 1996). They reduced laboratory testing frequency by up to 32%, and costs by nearly 28%, without compromising patient care. The use of established guidelines has been shown to help control costs in the hospital by reducing patients’ lengths of stay because they define appropriate interventions and reduce duplicate testing. They also help in eliminating the use of treatments of undocumented benefit (Dracup, 1996). 12 Objection to Guideline Use Guidelines cannot anticipate every possible complication that a practitioner may encounter with a given patient; they should be viewed as recommendations (Murphy, 1997). Implementation should be specific to each individual situation. The main objections to the use of clinical practice guidelines have been the concepts that this is cookbook medicine or that they may increase liability risk (Adelman, 1996). Dr. Adelman, a past president for the Michigan State Medical Society, went on to question the validity of pathways by stating that some may insult the skilled physicians who do not need them, while providing too much information to be useful for nonphysicians. Other objections included the questionable validity of clinical pathways as well as the notion that they may be too complex to be practical. The guideline must be evaluated and should note the pertinent characteristics in enough detail that practitioners can feel confident in matching their patient’s condition with the guide (Wilson, Hayward, Tunis, Bass, & Guyatt, 1995). To be clinically relevant, the benefits of following the practice guideline have to outweigh the associated potential for harm or additional cost. ACEP Guidelines Improving patient care was the main motivation for the development of the Clinical Policyfor the Initial Approach to Patients Presenting With a Chief Complaint ofNontraumallc Acute Abdominal Pain (ACEP, 1994) (Appendix A). The American College of Emergency Physictans obtained input from various specialist groups, such as the American Academy of Family Physicians and the American 13 College of Obstetricians and Gynecologists, for the creation of this policy statement. They developed this policy because an estimated 5% to 10 % of all emergency department visits are related to complaints of abdominal pain (ACEP, 1994). This study looked at the laboratory diagnostic evaluation of three separate discharge diagnoses related to the evaluation of acute nontraumatic abdominal pain. Those are acute cholecystitis/biliary obstruction, cholelithiasis/biliary colic, and/or panci eatitis. In addition to looking at the ACEP guide for testing, it was necessary to review why each test is indicated. This review is summarized in Appendix B. Hepatic enzymes (liver function tests), amylase or lipase, and a complete blood cell count are the laboratory tests recommended for patients with suspected gallbladder problems presenting to an ambulatory setting such as the emergency department. According to the ACEP policy, diagnostic imaging may be part of the evaluation for this condition though specific imaging tests are not delineated. Laboratory testing for suspected pancreatitis includes oximetry and/or arterial blood gases, serum calcium, hepatic enzymes, amylase and/or lipase, serum glucose and complete blood cell count (ACEP, 1994). Diagnostic imaging is not recommended as part of the initial testing when pancreatitis is suspected. Liver Function Tests. ACEP does not specify which tests are considered parts of liver function testing. In general it is essential to evaluate hepatocellular enzymes, biliary enzymes, liver excretion, and liver synthesis when testing liver function (Yoshida & Steinbrecher, 1997). The aminotransferases are enzymes normally present within liver parenchymal cells and may leak into the systemic circulation 14 when injury occurs to the hepatocyte plasma membrane. Aspartate aminotransferase (AST), formerly SGOT, and alanine aminotransferase (ALT), formerly SGPT, are the tests for hepatocellular damage (Andreoli, Bennett, Carpenter, & Plum, 1997). Bihary enzymes that may test for obstruction or impaired bile flow are serum alkaline phosphatase and gamma-glutamyl transpeptidase (GGTP) (Pagana & Pagana, 1997). The test for liver excretion is serum bilirubin. When testing for the liver’s ability for synthesis, serum albumin and the prothrombin time (PT) or the international normalized ratio (INR) are evaluated (Yoshida & Steinbrecher, 1997). Appendix B lists possible causes for abnormal liver function studies. Complete Blood Count (CBC). The complete blood count is evaluated because leukocytosis, elevated white blood cell count, may be seen with any inflammatory response of the pancreas or gallbladder (Kadakia, 1993). Because the white blood count may be elevated in other pathologic conditions, it is important to correlate the CBC with clinical findings (Pagana & Pagana, 1997). Amylase and Lipase. In uncomplicated pancreatitis, the serum amylase begins to increase within 12 hours and may remain elevated for 3 to 5 days (Moscati, 1996). Amylase may also be elevated for a variety of other problems such as bowel perforation, penetrating peptic ulcer, parotitis, ectopic pregnancy, and severe diabetic ketoacidosis (Pagana & Pagana, 1997). Lipase level more closely parallels the clinical course of acute or chronic pancreatitis and can remain elevated up to 10 days (Moscati, 1996). In addition to 15 pancreatitis, lipase may be elevated with acute cholecystitis, renal failure, and intestinal obstruction or infarction (Pagana & Pagana, 1997) Other. Laboratory Testing. In acute pancreatitis, other laboratory tests may correlate with the clinical findings. Specifically, hyperglycemia, hypocalcemia, hypoalbuminemia, and hypoxia may be seen with acute pancreatitis (Kadakia, 1993). Summary The three major types of biliary tract emergencies are acute cholecystitis, acute cholangitis, and acute pancreatitis. These conditions have the potential to be very serious and possibly lethal (Kadakia, 1993). Adequate laboratory evaluation is an essential component of the diagnostic work-up for these conditions (Moscati, 1996). Utilization of guidelines addresses both the cost and quality issues of patient care (Costello & Murphy, 1995). With an understanding of appropriate testing, health care practitioners evaluating clients with biliary type abdominal pain may be wise to follow clinical policy guidelines such as those promulgated by the American College of Emergency Physicians. 16 Chapter III Methodology This chapter describes the methodology utilized in this study to evaluate the extent to which emergency department healthcare practitioners followed established guidelines for the laboratory diagnostic evaluation of biliary or pancreatic abdominal pain. Included in this chapter are the operational definitions, research design, sample, procedures, instrumentation, and the data analysis utilized in this study. Hypothesis Health care practitioners working in an acute care emergency department use diagnostic testing, consistent with established practice guidelines, when ordering laboratory tests for adult patients with suspected biliary or pancreatic pathology. The type and frequency of laboratory testing for adults was compared with the Clinical Policy for the Initial Approach to Patients Presenting With a Chief Complaint of Nontraumatic Acute Abdominal Pain established by the American College of Emergency Physicians (1994) (Appendix A). Operational Definitions The following terms are defined as they were used in this study. 1. Subjects studied were adult patients, age 18 or older, who had an emergency department discharge diagnosis consistent with cholecystitis (acute biliary obstruction), cholelithiasis (biliary colic), and/or pancreatitis. 17 2. Liver function tests included AST (SCOT), ALT (SOFT), GGTP, alkaline phosphatase, serum total bilirubin, serum albumin, and PT/ INR (Yoshida & Steinbrecher, 1997). 3. Health care practitioners for the purposes of this study were emergency physicians and/or nurse practitioners working in a level II trauma/emergency department in a 500+ bed community based hospital in northwest Pennsylvania with an average annual total of 35,000 patient care visits. Research Design The study was conducted as a nonexperimental, retrospective review of emergency department charts of adult patients with the discharge diagnosis of cholecystitis (acute biliary obstruction), cholelithiasis (biliary colic) and/or pancreatitis. The laboratory tests ordered for these patients were compared to those recommended by the ACEP (1994) for that discharge diagnosis. Procedures and Sample The sample was adults who were discharged from a level II trauma/ emergency department in northwest Pennsylvania with the diagnosis ofcholecystitis (acute biliary obstruction), cholelithiasis (biliary colic), and/or pancreatitis. Charts were identified from the emergency department log, which contained the discharge diagnosis. Patients were considered discharged from the emergency depaitment whether they were admitted to the medical center or sent home. Those excluded for this study were patients under age 18, patients with pain related to previous trauma, and those in the last trimester of pregnancy or the first 18 month postpartum. Other patients not eous.dered for this study were those with extra­ abdominal causes of abdominal pain such as myoeardial infarction or pneumonia. Patients with toxic exposure or envenomation were also excluded for this study. A spreadsheet was utilized for the collection of the data from the patient medical records (see Appendix C). That information was entered into a computer for analysis. Informed Consent Patient consent was not necessary since there was not any manipulation of treatment or testing for the collection of these data. Compete anonymity was strictly maintained for all patients and healthcare practitioners involved. Permission from the medical center’s Nursing Research Approval Committee was obtained prior to review of charts or collection of data. Data Analysis Research findings were presented using frequencies and percentages for this descriptive study. Additional mean laboratory result data were presented when that information was pertinent to the conclusions of this study. Summary The goal of this study was to determine the extent to which emergency health care practitioners’ laboratory ordering practices were consistent with the American College of Emergency Physician guidelines for evaluating patients with biliary and/or pancreatic problems. This chapter delineated the hypothesis, operational definitions, research design, sample, and data analysis utilized for this s y 19 Chapter IV Results This chapter provides the results of the laboratory testing obtained for this sample of patients with the discharge diagnosis related to gallbladder or pancreatic pathology. A total of 50 charts, with related diagnoses, were reviewed over a 4 month period at a level II trauma/emergency department located in northwestern Pennsylvania. Frequencies and percentages have been used to describe the results of this study. These data were reported separately due to the different serum laboratory testing suggested by ACEP (1994) for gallbladder and pancreatic disease. Demographics Of the 50 charts reviewed, 33(66%) of them had a primary discharge diagnosis of biliary colic, cholecystitis, and/or cholelithiasis. The other 17(24%) patients had a primary diagnosis related to acute pancreatitis. Table 1 delineates the sex and ages of those patients’ charts reviewed in this study. The ages are further broken down under those with gallbladder disease and those with pancreatic disease. The age range for those patients with gallbladder disease was 16 to 74 years with the mean age being 42 years. Those patients with pancreatic pathology had a range of 33 to 84 years with the mean of 59 years. 20 Table 1 Demographic Data n Gender % (n=50) Male 18 36% Female 32 64% 33 66% 30 years 13 39% 31-59 years 12 36% 8 24% 17 34% 0 0% 8 47% 9 53% Gallbladder Disease Ages > 60 years Pancreatic Disease Ages <30 years 31-59 years > 60 years Note. Percentages rounded to the nearest whole number. 21 Gallbladder DiseaseTestinp Of the 33 patient charts reviewed with gallbladder pathology, 26 (79%) were discharged home. Seven patients (21%) of those evaluated required admission for further assessment and treatment. All laboratory test mean results reported are rounded to the nearest whole number when appropriate. Under laboratory testing done for this group with gallbladder disease, 100% had a complete blood count (CBC) with differential. The white blood cells were modestly elevated for 11 (33%) of these patients, with the overall mean of 10,000/mm3 for all 33 patients. This hospital laboratory referenced a normal white blood cell count range as 4,500 tol 1,000/mm3. A serum amylase was ordered for 30 (91%) of the 33 patients in this sample. The mean amylase value was 55 with the normal range referenced as 16 to 88 U/L (SI units). The serum lipase was ordered for 26 (79%) for this same group with a mean result of 103, the referenced normal range for lipase being 14 to 300 U/L (SI units). One or more liver enzymes were ordered for 25 (76%) of the 33 patients evaluated for gallbladder disease. Table 2 explains the breakdown of liver enzymes ordered for this group of patients. The mean value for the serum AST was 38 with the normal listed as 1 to 37 U/L. The ALT mean was 1S with the laboratory normal listed as 1 to 42 U/L. The mean value for GGTP tested was 109 with the laboratory normal listed as 1 to 60 U/L. Alkaline phosphatase had a mean of 107 (normal range 30 to 105 U/L). The serum total bilirubin mean was 0.9 (normal range 0.2 to 1.2 mg/dl). 22 Table 2 Liver Enzyme Testing for Gallbladder Disease Test n % Aspartate Aminotransferase (AST or SGOT) 16 48% Alanine Aminotransferase (ALT or SGPT) 10 30% Gamma-glutamyl Transpeptidase (GGTP) 9 27% Alkaline Phosphatase 21 64% Total Bilirubin 19 58% 1 3% Prothrombin Time Note. Percentages rounded to the nearest whole number. Under other testing, blood chemistry SMA-6 was ordered 76% (n=25) of the time. Serum glucose was also ordered for 73% (n=24) of this patient population. The mean value for the serum glucose was 120 with the normal range referenced at 65 110 mg/dl. A urinalysis was ordered for 14 (43%) of these patients. An electrocardiogram (ECG) was also ordered for 14 (43 /o) pati Diagnostic imaging is indicated under the ACEP (1994) guideline:s for this patient population though the recommended imaging is not delineated. Diagnostic imaging was performed 73% (n-24) of the lime for this group of patients with gallbladder pathology. An AP chest x-ray is included as part of the abdominal series radiographs at this medico! center location, though it was ordered separate!, for 6 23 (18%) of these patients. Twelve patients (36%) had an abdominal series ordered as part of their diagnostic work-up. Six patients (18%) had both an abdominal series and a gallbladder sonogram ordered. When a gallbladder sonogram was performed, it was found to be diagnostic for pathology for 11 (65%) of the 17 times it was ordered. Table 3 shows the breakdown of the diagnostic imaging for this population with gallbladder disease. Table 3 Diagnostic Imaging for Gallbladder Disease Image n Chest X-ray 6 18% Abdominal Series 12 36% Gallbladder Sonogram 17 52% 1 3% Computerized Tomography of the Abdomen % Note, Percentages rounded to the nearest whole number. Pancreatic Disease Testing Seventeen charts were reviewed with the primary discharge diagnosis of acute pancreatitis. Of this group 14 (82%) required admission for further treatment and 3 (18%) were discharged home. All mean laboratory results reported for this part study were rounded to the nearest whole number. 24 Again, 100% of this patient population with possible pancreatic pathology had a complete blood count with differential. The mean value for the white cell count was 11,000/mm3 with the normal referenced at 4,500 to 11,000/mm3. Serum amylase and lipase were ordered for 100% ofthe 17 patients with the dischaige diagnosis of acute pancreatitis. The mean amylase level for this group was 410 with the normal range listed by the medical center laboratory as 16 to 88 U/L. The serum lipase mean was 5471 with the normal listed as 14 to 300 U/L. Table 4 provides the frequency of the liver enzymes testing for this group. Table 4 Liver Enzyme Testing for Pancreatic Disease Test n % Aspartate Aminotransferase (AST or SGOT) 10 58% Alanine Aminotrasferase (ALT or SGPT) 8 47% Gamma-glutamyl Transpeptidase (GGTP) 4 24% 11 65% 4 24% 0 0% Alkaline Phosphatase Total Bilirubin Prothrombin Time Note, Percentages rounded to the nearest whole num One or more of the liver enzymes were ordered for 13 (77%) ofthe 17 patients in this group. The serum AST testing mean value was 172 wtth the normal 25 listed as 1 to 37 U/L. The mean value for the se.™ ALT was 173 „ith normal listed as 1 to 42 U/L. The GGTP mean fot this gra, was 15(, „ith the as 1 to 60 U/L. The serum alkaline phosphate mean was 123 with the normal referenced at 30-105 U/L. The serum total bilirubin mean was 1.7 (normal 0.2 to 1.2 mg/dl). Serum calcium was ordered twice (12%) for this group of seventeen pancreatitis patients. Serum glucose was ordered for 100% of this patient population with the mean value of 176 with the normal range reported as 65 to 110 mg/dl. Although diagnostic imaging is not referenced in the ACEP (1994) clinical policy for this group, the frequency of this testing was delineated in this study since it was performed for 15 (88%) of the 17 patients. Table 5 describes the diagnostic imaging performed. Table 5 Diagnostic Imaging for Pancreatitis Disease Image Chest X-ray Abdominal Series Gallbladder Sonogram Computerized Tomography of the Abdomen Note. Percentages rounded to the nearest whole n n % 7 41% 10 58% 1 6% 2 12% 26 Under other testing, basic serum electrolytes, were ordered for 100% of these patients. A urinalysis was ordered 5 (30%) ti: imes. An ECG was performed for 13 (76%) of the 17 patients. Summary This chapter presented the results of the testing performed for the diagnostic evaluation of adult patients presenting with nontraumatic acute abdominal pain related to gallbladder and/or pancreatic pathology. Although serum laboratory testing was the main focus of this study, diagnostic imaging results were delineated to provide a more complete overview of the testing performed for this patient population. 27 Chapter V Discussion This chaptei summarizes the results of this study. Conclusions are discussed and recommendations are made for future research. Summary The purpose of this study was to determine the extent that health care practitioners working in an emergency department followed the ACEP clinical policy for the evaluation of gallbladder or pancreatic disease. The clinical policy was the Clinical Policy for the Initial Approach to Patients Presenting With a Chief Complaint ofNontraumatic Acute Abdominal Pain (Appendix A). The results for the evaluation of gallbladder disease demonstrated that these practitioners’ ordering practices were consistent with the ACEP policy for 23 (70%) of the 33 patients with this complaint. That means that they ordered a complete blood count (CBC), amylase and/or lipase, and one or more liver enzymes 70% of the time. Of this group, no liver enzymes were ordered for 8 (24%) of the patients. No serum amylase or lipase enzymes were ordered for 3 (9%) of the 33 total patients. When evaluating patients for pancreatic pathology, this group followed the complete ACEP clinical policy for two (12%) of the 17 patients. This included testing for a CBC, amylase, lipase, one or more liver enzymes, serum calcium and plasma glucose. The ordering patterns associated with serum calcium affected the overall compliance since it was only ordered for 2 (12%) of the 17 patients. If the 28 requirement for serum calcium was excluded, then 13 (77%) of the 17 patients had testing consistent with the ACEP recommendations. The serum amylase and lipase mean laboratory results for the gallbladder disease patients were within normal limits. In contrast, the serum amylase and lipase with those patients diagnosed with pancreatitis provided important results. The overall serum amylase mean for that group was 4.6 times the upper limit of normal. The mean result of serum lipase for the same group was 18.2 times the upper limit of normal. With only 17 patients having the discharge diagnosis of pancreatitis, the results may be limited by the small number in this sample. Also, with 82% of the patients with pancreatic disease requiring admission, this group may have been sicker than other patient samples. Under other laboratory testing, these health care practitioners ordered a serum troponin-t enzyme test for 9 (18%) of the 50 patients in this study. This enzyme test becomes elevated within several hours of myocardial damage. Other cardiac related testing included electrocardiograms performed for 27 (54%) of the total patients. The frequency of this testing may indicate that the symptomatology of this patient population suggested heart disease as well as gallbladder or pancreatic pathology. The patients may have had other associated complaints in addition to epigastric, right upper abdominal pain, and/or a positive Murphy s sign. Pertinent radiologic testing for the group of patients with gallbladder disease demonstrated that when a gallbladder sonogram was done, it was diagnostic for 11 (65%) of the 17 times it was ordered. Though radiologic testing was not specifically 29 being evaluated as pan of this study, this flndil,g miy have relevan90% hepatic functional impairment. Prothrombin time/INR Exclude extrahepatic disorders (albumin loss, malnutrition, vitamin K deficiency, nephrotic syndrome). Adapted from sources: 1. Yoshida and Steinbrecher, 1997. 2. Pagana and Pagana, 1997. Appendix C 39 Gallbladder Disease Data Sheet A I B | C | D 1 Ga Ibladder Disease E F G H I J K ---------- . ----------Liver Enzymes Age Sex Diag CBC/WBC [Amylase Lipase AST ALT GGTP Aik Phos T. Bili x x 3 4 5 6 X 7 X 8 £ 9 X 10 X 11 X 12 X 13 X 14 X 15 X 16 X 17 X 18 X 19 X 20 X 21 X 22 X 23 X 24 X 25 X 26 X 27 X 28 X 29 X 30 X L PT Appendix D 40 Pancreatitis Data Collection Sheet 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 a I B I D I E I Pancreatic Disease F G H I J K L M N O Liver Enzymes Age Sex CB Amylase Lipase AST ALT GGTP Aik Phos T. Bili PT Ca BS Ox/ABG x__ X X X X__j___ X_______ X__ X _ X___ X X___________ X___________ X _ X_______ X___________ X X___________ X________ X________ X___________ X___________ X___________ X___________ X _______ X_________ X___________ X