THESIS HURS 1998 H647u
c.2.
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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 relevan
radiologic studies performed for this group.
Conclusions

The focus of clinical practice guidelines is to address the issues of cost,

quality, and liability. The utilization of such guidelines in practice is described in

Hesook Suzie Kim’s (1983) concept of operational control decisions. The use of

established protocols for practice is encouraged in an attempt to control costs and
address quality of care.

Clinical policy guides are meant to provide input for suggested testing and

treatment for clinical conditions. To utilize all of the serum laboratory testing without
addressing individual concerns would most likely add additional costs without

additional benefits. The practitioner must evaluate each case, keeping in mind the
testing that is recommended for each specific complaint. The nature of the complaint

and the patients’ clinical condition should dictate the level of testing performed.
The overall compliance with the ACEP clinical policy of 70% for diagnostic

laboratory evaluation for patients with gallbladder disease is significant since there is
no current departmental requirement to follow such guidelines. Though the overall
compliance for diagnostic evaluation of pancreatic disease was not as good as the one

for gallbladder disease. When the requirement for serum calcium was excluded for
the evaluation of pancreatic pathology, tire compliance improves to 77%. These

findings are also significant since there has been no formal educational process in

30

place to ensure that these health care practitioners are aware of such
recommendations.
Recommendations

The utilization of clinical practice guidelines is generally recommended for
nurse practitioners whether they work in an independent or collaborative practice.

Adoption of clinical policies such as the ACEP one reviewed in this study would be
appropriate for any ambulatory care practice setting where patients are evaluated for

pancreatic or gallbladder disease.
There are several recommendations for future research relative to this topic.

First, a comparative study looking at the ordering practices of nurse practitioners and
physicians working in similar practice locations may be useful. Research examining
the laboratory testing patterns before and after practice guideline educational

programs are provided would be recommended to evaluate impact of such programs.
Other research might include the review of adherence to established

guidelines and comparing the utilization of the guide to patient outcomes. A separate

review of radiologic studies performed for this patient population may be able to
demonstrate which diagnostic imaging study is most appropriate for the specific

complaints of gallbladder or pancreatic disease.
A larger sample size in other institutions and locations could provide more
reliable information about adherence to similar practice policies. Future scientific

research needs to address clinical patient outcomes related to the utilization of

established practice protocols.

31

The intent of maintaining quality of care and controlling costs associated with

the medical evaluation of patients with specific disease conditions cannot be

overlooked. The utilization of clinical practice guidelines is a valid attempt at

accomplishing those goals for health care practioners.

32

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36

Appendix A
ACEP Clinical Policy

ED Diagnosis
1. Cholecystitis

Recommended testing

Hepatic enzymes (liver function tests)

(acute)Zbiliary obstruction

Amylase or lipase, complete blood count

Cholelithiasis/biliary' colic

Diagnostic imaging

2. Pancreatitis

Amylase/lipase

Hepatic enzymes (liver function tests)
Complete blood count, calcium, glucose,

Oximetry / Consider arterial blood

37

Appendix B
Causes for Abnormal Liver Test

Test

Possible causes of abnormal results

1. Hepatocellular enzymes

AST (SGOT) or

Hepatitis, cirrhosis, cholestasis, hepatic ischemia or

ALT (SGPT)

necrosis, drugs, alcohol, pancreatitis, tumor or myositis.

2. Biliary enzymes

Alkaline phosphatase

Cirrhosis, biliary obstruction, liver tumor, intestinal

ischemia, osteoblastic activity (bone tumor or fracture).

GGTP

Hepatitis, cirrhosis, hepatic ischemia or necrosis,

cholestasis, hepatotoxic drugs or excessive alcohol,
pancreatitis, liver tumor, resolving MI or congestive

heart failure.
3. Liver excretion
Unconjugated bilirubin

Hemolysis, hepatitis, sepsis, large-volume transfusion,
cirrhosis, sickle cell anemia, Gilbert or Crigler-Najjar

syndromes.
Conjugated bilirubin

Gallstones, both hepatocellular and cholestatic disease,
genetic metabolic defects, liver metastasis.

38

Appendix B continued.

4. Liver synthetic function
Serum albumin

Hypoalbuminemia and coagulopathy imply >90%

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