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THESIS HURS 1998 K656w
c.2
Kolpien-Bugaj, Karen.
White blood cells on
gram stain as a
1998.
White Blood Cells on Gram Stain as a
Treatment Indicator for Chlamydial Infection
by
Karen Kolpien-Bugaj, BA, BSN, RNC
Submitted in Partial Fulfillment of the Requirements
for the Master of Science in Nursing Degree
Approved by:
Jy^ith S. Schilling; CRNP, PhEjZ
Committee Chairperson
Edinboro University of Pennsylvania
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Jeanne M. Weber, EdD, CRNP
Committee Member
Edinboro University of Pennsylvania
Date
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Nancy Rea, MHSA
Committee Member
Erie County Department of Health
______
Date
c- A
Abstract
Chlamydia infection in the United States has the highest incidence of
all infectious diseases tracked by the Centers for Disease Control and
Prevention. It is often without symptoms and there is no rapid, cost-effective
test method that provides both high sensitivity and specificity. Consequently,
the spread of the disease often occurs by patients who are unaware that they
are infected. Gram stain is one test which can be performed relatively quickly
and inexpensively. Although not able to directly detect chlamydia, it is
capable of detecting the presence of white blood cells (WBCs) indicative of
infection.
This study sought to examine what relationship may exist between
either the presence or absence of WBCs on Gram stain and chlamydia
infection. It also sought to identify other clinical factors with relationships to
chlamydia infection.
The clinic charts from 54 patients of a public health sexually
transmitted diseases clinic in northwestern Pennsylvania, were reviewed. A
matched groups design comparing the Gram stain WBC results of patients
who tested DNA chlamydia-positive and DNA chlamydia-negative was
performed. Other clinical factors were also compared between the two
groups.
ii
The Gram stain detected 93% (P=0.00014) of the chlamydia infections
present. In the group without chlamydia it erroneously predicted infection in
44% of the patients. No other factors were identified as more specific
indicators of chlamydial infection.
The author concluded that of the factors studied, the Gram stain was
the best clinical tool for prescribing presumptive treatment for chlamydia. The
data also support the literature by indicating that Gram stain is neither highly
sensitive nor specific for chlamydia, and further research and better tests are
needed for rapid effective detection of chlamydial infection.
iii
Table of Contents
Chapter
Page
Chapter 1. Introduction
1
Background of the Problem
2
Conceptual Framework
5
Statement of the Problem
16
Assumptions
17
Definition of Terms
18
Limitations
21
Summary
22
Chapter 2. Review of Literature
24
Goals and Guidelines for Screening and Treatment
24
Diagnostic Tests
26
Screening Characteristics
29
Treatment Characteristics
34
Treatment before test results
34
Treatment after test results
35
Nurse Practitioner Role
38
Summary
41
iv
Chapters. Methodology
44
Hypothesis
44
Operational Definitions
44
Research Design
46
Procedures
46
Sample
47
Informed Consent
49
Instrumentation
49
Demographics
49
Independent Variables
49
Dependent Variable
50
Data Analysis
51
Summary
51
52
Chapter 4. Results
Demographic Data
52
Clinical Indicators and DNA Probe Results
52
Gram Stain Versus Other Clinical Indicators
56
Gonorrhea Versus Chlamydia Results
57
59
Chapters. Discussion
59
Conclusions
v
Recommendations
61
References
64
Appendixes
69
A. Application for Access to Protected Data
70
B. User’s Guide to Access to Protected Data
86
C. Erie County Department of Health STD Clinic
92
Patient Consent Form
93
D. Data Collection Spreadsheet
vi
List of Tables
Table
Page
1. Chlamydia Infection in Heterosexual Men in a Study
Reported by Rietmeijer et. al. (1991)
31
2. Gram Stain Urethral Smear Results in 219 Men With
and Without Urethral Discharge from a Study Reported
by Janier et al
33
3. Patients With Positive Screening Tests Who Were
Not Treated at Initial Visit, and Time Intervals Until
Treatment Was Received, in a Study of 24,823 Patients
36
by Schwebke et. al
4. Criteria For Presumptive Treatment for chlamydia as
Reported by Nurse Practitioners in a Survey Performed
by Alexander et. al
40
5. Demographic Data for Study Sample Groups
53
6. DNA Probe Chlamydia Results and Results of Other
Clinical Indicators in Patients From the STD Clinic in this
54
Study
vii
List of Figures
Figure
Page
6
1. The Epidemiologic Triangle
2. The Dever Epidemiologic Model
10
3. The Epidemiologic Prevention Process Model
13
4. The Holistic Epidemiologic Prevention Process
15
Model for Advanced Practice Nursing
viii
1
Chapter One
Introduction
In this chapter, the history of sexually transmitted diseases (STDs) and
their impact on the health of individuals and communities will be examined
utilizing models of epidemiology as they are applied to public health and
advanced practice nursing. Specifically, the need for more consistent testing
and treatment guidelines for screening and treatment of patients with
Chlamydia trachamatis (chlamydia) will be reviewed. The use of Gram stain
and its clinical indications for the presence or absence of chlamydia are a
focus.
Historically, Hippocrates described syphilitic-type sores as early as 460
B.C. (Hippocrates, -460 B.C./1972). By 1953, penicillin was being heralded
as “the drug which would eradicate venereal disease” (Commonwealth of
Pennsylvania Department of Health [CPDH], 1970, p.17). The incidence of
syphilis fell from 106,539 cases in 1947, to a low of 6,516 in 1955. With
these dramatic results, funding that had supported a nationwide venereal
disease program was drastically decreased. The consequences were
evidenced by a rebound to more than 100,000 new cases of syphilis in 1962
(CPDH, 1970).
Richard D. Lamm, former governor of Colorado and director of
2
the Center for Public Policy and Contemporary Issues at the University of
Denver, has written “The Ten Commandments of Health Care” (Lamm,
1990). In it he cautions, “We must. . . establish norms and standards for
diagnostic and therapeutic practice that encompass both costs and medicine”
(p. 129). With chlamydia having pushed into the forefront as the leading
infectious disease in the United States (Eng & Butler, 1997), the domain of
public health has a challenge in effectively combating a 1990s compliment to
the syphilis of the past. Additionally, it comes at a time when limited
resources and increased competition within health care are mandating that
financial costs be examined more closely than ever before (U.S. Department
of Health & Human Services [HHS], 1994). For these reasons, it is
paramount that all primary health care providers judiciously strive to identify
patients at risk for chlamydia (Eng & Butler, 1997) in order to examine, test,
and appropriately treat them utilizing both valid and cost-effective means.
Background of the Problem
Tracked for the first time in 1995, chlamydia was the most common
infectious disease in the United States (Centers for Disease Control and
Prevention [CDC], 1996b). The 477,638 reported cases cited in the annual
report from the Centers for Disease Control and Prevention (CDC) showed
the incidence of chlamydia exceeded not just other sexually transmitted
3
diseases (STDs), but all other infectious diseases as well (CDC, 1996b). The
State of Pennsylvania counted 22,828 cases of chlamydia in 1995, with 825
of those being from Erie County (Erie County Department of Health, 1998).
In October 1997 the report of statistics for 1996 revealed that chlamydia
retained its position as the leading infectious disease (CDC, 1997d). In PA
and Erie County the 1996 cases numbered 18,445 and 624, respectfully (Erie
County Department of Health, 1998). Additionally, at the close of the 40th
week in 1997 when the 1996 report was released, the year-to-date national
case total for chlamydia in 1997, exceeded those for 1996 by 10,325 cases
(CDC, 1997e).
Screening for chlamydia has been deemed a priority by the CDC
because 75% of infected women and 50% of infected men are asymptomatic
(CDC, 1997c). In women, untreated chlamydia can progress to pelvic
inflammatory disease, infertility, or potential ectopic pregnancy. The cost of
treating these complications exceeds $2 billion annually (CDC, 1997c). The
CDC estimated that one-half of all chlamydia cases occurred in teens ages
15 to 19, and predicted that the impact to both lives and cost could be greatly
reduced by expanded screening for the disease. Although less likely to suffer
from untreated complications, men have rarely been included in routine
screenings. They can, however, develop sequelae such as epididymitis or
4
proctitis and their untreated chlamydial infections become a risk to female
sexual partners who, if pregnant, may pass that risk onto an unborn fetus
(CDC, 1996a). Because chlamydia is sexually transmitted, decreasing the
incidence of this disease and its complicating sequelae must include
screening and appropriate treatment for both men and women (CDC, 1996a).
Traditionally, consistent guidelines for screening have been lacking
due to the large number of screening tests available (Schachter et. al.,
1992). Additionally, once screened, patients are often unable to be located
or refuse to return for treatment. (Schwebke, Sadler, Sutton, & Hook, 1997).
This has created a need for tests that provide immediate results and, in the
absence of such tests, clear guidelines or indicators for presumptive
chlamydia treatment (Schachter et. al., 1992).
As of 1994, major medical authorities including the American Academy
of Pediatrics, the American Academy of Family Practice, the American
College of Obstetricians and Gynecologists, the American Medical
Association, the Centers for Disease Control and Prevention, and the United
States Preventive Services Task Force have advocated routine screening for
STDs (Eng & Butler, 1994). Criteria for identifying patients at risk and in
need of screening include all patients in STD, family planning, or
adolescent clinics, as well as anyone under the age of 20 who admits to
5
multiple sex partners. They added that prostitutes, patients with a past
history of STDs, or those who are untreated since sexual contact with an
infected partner, should also be screened.
Conceptual Framework
In developing the conceptual framework for this study, three existing
conceptual frameworks were reviewed. They were; a) The Epidemiologic
Triangle, b) The Dever Epidemiologic Model, and c) The Epidemiologic
Prevention Process Model. These models were then integrated to form The
Holistic Epidemiological Prevention Process Model for Advanced Practice
Nursing, used in this study.
Screening has been encouraged for the identification of infection and
for risk factors that, when appropriately acted upon, will prevent disease
(Mausner & Bahn, 1974). Historically, the theory of epidemiology originated
with Hippocrates in the 5th century B. C., in his writings titled “On Airs,
Waters, and Places” (Hippocrates, -460 B. C./1972). Utilizing this premise,
in 1958, Leavell and Clark (1979) developed an epidemiological concept that
depicts the natural history of disease in man. It states that disease begins via
a stimulus generated by interrelations between the agent, host, and
environment. These three factors are depicted in The Epidemiologic Triangle
(Figure 1) as the three points of the triangle. Epidemiology theory seeks to
6
ENVIRONMENT
AGENT
FIGURE 1
HOST
The Epidemiologic Triangle
(Adapted from Mausner, J. S., & Bahn, A. K.: Epidemiology An
Introductory Text. W. B. Saunders Company, Philadelphia, 1974, p. 33.)
7
identify, then remove or interrupt, interrelations between these factors as a
means of disease prevention and control (Mausner & Bahn, 1974). For
epidemiological purposes Mausner and Bahn defined these three factors.
The first, the host, is the organism whose health is being focused upon.
There are conditions which must be true of the host for disease to occur. In
this study the hosts were the STD patients, and sexual activity of the host
would be a condition necessary for the disease of chlamydia to occur.
The second factor is the agent and is something which may be present
or absent, but alone is not sufficient to cause disease without certain
conditions within the other two factors being met. Chlamydia is the agent that
was examined in this study. The third factor is the environment. This is the
surroundings of the host and contains conditions that impact the host. Often
these surroundings are separated into the three categories of biological,
social, and physical environments. STD patients had biologic environments
(ie: individual immune status), social environments (ie: peer pressure), and
physical environments (ie: accessibility to a location conducive for sexual
activity to occur) as potential catalysts for chlamydia infection.
As primary care providers, nurse practitioners need to be aware of
which patients (potential hosts) to screen for chlamydia. They must have
adequate knowledge of which testing methods will provide optimal accuracy
8
for the diagnosis and effective treatment of chlamydia (the agent).
Additionally, they must be aware of methods for prevention of reinfection,
spread of the disease, and complicating sequelae (environmental influences).
Leavell and Clark’s (1979) model defined the point at which
interrelations between the host, agent, and environment first generate a
stimulus for disease as a period of “Prepathogenesis.” During this phase
they cite two components of possible intervention termed “health promotion”
and “specific protection.” Preventive measures implemented within this
phase are called “primary prevention.” The second period of disease
according to Leavell and Clark (1979), is that of “Pathogenesis.” In this
phase the host produces a response to the stimulus from phase one. They
listed the following three components of possible prevention within this
period: a) early diagnosis and prompt treatment, b) disability limitation, and
c) rehabilitation. Measures of prevention implemented in the first two they
called “secondary prevention.” Any preventive measures instituted during the
rehabilitation phase they termed “tertiary prevention.
Primary prevention measures such as educational campaigns that
focus on sexuality, condom use, disease education, and esteem building, are
all utilized within the scope of public health. Secondary prevention is
9
accomplished through early diagnosis and effective treatment and has three
objectives that are: a) to prevent and cure disease processes, b) to prevent
the spread of communicable diseases and, c) to prevent complications and
sequelae of communicable diseases (Leavell and Clark, 1979).
These basic definitions of primary, secondary, and tertiary prevention
continue to be utilized within epidemiology today, but have been broadened
to accommodate science and medicine by taking diseases far beyond the
confines of the “germ theory” (Phillips, 1986). Expounding upon the three
factors of The Epidemiologic Triangle Alan Dever, health-policy analyst,
created The Dever Epidemiological Model (Figure 2) (Clark, 1992). Dever
identified four determinants of health status and listed three comprising
components within each. They are: a) human biology comprised of genetics,
physiological function and maturation, b) environment comprised of physical,
psychological and social elements, c) life-style comprised of employment,
consumption, and leisure, and d) health-care system comprised of
availability, accessability, and utilization.
Dever’s model was relevant to the STD patients in this study as
follows:
1
Biology. Each patient’s genetics were individual and although
patients were matched for age, gender, and race physiologic function and
10
human biology
Genetics
Physiologic Function
Maturation
ENVIRONMENT
Physical
Psychological
Social
LIFE-STYLE
Employment
Consumption
Leisure
HEALTH-CARE SYSTEM
Availability
Accessibility
Utilization
FIGURE 2
The Dever epidemiologic model
(From Clark, M. J.: Nursing In The Community. Appleton &
Lange, Norwalk, Connecticut, 1992, p. 114.)
11
maturation levels were unique to each patient. The numbers of white blood
cells seen on each patient’s Gram stain was the biologic indicator used in the
study.
2. Environment. The physical environment included the surroundings
where the patient lives. The psychological and social encompassed
dynamics of interpersonal relationships, values, and emotions that all
influenced the choices surrounding the patients’ sexual activities. Whether
the patient had contact to a sexual partner infected with chlamydia, and other
sexual history of the patient were environmental indicators for infection.
3. Life-style. Whether the patients were employed or in school, and
whether or not they used alcohol or recreational drugs is data that was
included on the patients’ charts but not recorded as part of this study.
Leisure time activities often are largely influenced by the above. The
combination of these factors influenced patient choices that were
determinants of patients’ health status (ie: decisions to be sexually active,
have multiple sex partners, condom use etc.) As an indicator of lifestyle,
patients in the study were matched as either “established" or “first visit”
clients.
4 Health-care system. Patients can only utilize health care that is
accessible and available to them. The clinic studied provided anonymity and
12
provided testing and treatment at no charge and offered various clinic
schedules as a means of heightening availability and client accessability.
T. S. Eliot wrote, “The whole earth is our hospital” (1943, p. 30). This
premise has traditionally separated community or public health from other
forms of health care. Specifically, in community nursing the principles of
epidemiology are utilized as a foundation for practice which is geared not just
to the individual but to the “whole earth,” the community. By combining the
levels of prevention identified by Leavell and Clark (1979) with Dever’s
Epidemiological Model, the Epidemiologic Prevention Process Model
(Figure 3), utilized in community health nursing, was developed (Clark, 1992).
In this model, the above four components make up “Step 111 or the “client
assessment” phase of the nursing process. In “Step 2" a “nursing diagnosis”
is derived from the assessment. Steps 3 through 5 utilize the three levels of
prevention; primary, secondary and tertiary. Using these, in “Step 3" a
nursing plan of intervention is decided upon. In “Step 4" the plan is
implemented and in “Step 5" an evaluation of the outcome completes the
nursing process.
By building upon the epidemiologic prevention process from nursing
and combining it with the holisitic approach characteristic of advanced
practice nursing, The Holistic Epidemiologic Prevention Process for
13
Nursing Process
Step 1
Client
assessment
Epidemiologic perspective
Human Biology
Environment
Life-style
Health System
Step 2
Nursing
diagnosis
Step 3
Planning
intervention
Step 4
Implementing
the plan
Levels of prevention
Primary prevention
Secondary prevention
Tertiary prevention
Step 5
Evaluating
FIGURE 3
The epidemiologic prevention
process model
(From Clark, M. J.: Nursing In The Community. Appleton &
Lange, Norwalk, Connecticut, 1992, p. 119.)
14
Advanced Practice Nursing Model (Figure 4) can be derived (Chinn &
Kramer, 1995). The components of this model are as follows:
Step 1. The performance of a holistic client history, assessment, and
examination.
Step 2. Determination of a clinical diagnosis based upon the
assessment data.
Step 3. Development of a plan of treatment and/or therapy.
Step 4. Execution of the plan via order, prescription, or referral. This
plan may combine the various levels of prevention and may include
medications, behavior modification, and lifestyle changes. It also may
incorporate ancillary or alternative health care providers as needed to provide
a holistic plan of care.
Step 5. Evaluation of the plan, and a holistic client reassessment.
The medical community has traditionally been one that is disease
focused, not patient focused (Keeling, 1996). Assessment for appropriate
treatment, patient education, and contact notification for communicable
diseases such as chlamydia were historically referred to public health nurses
and officials, who retrospectively applied principles of epidemiology to
medical diagnoses and treatments already rendered. Nurse practitioners are
educated to see patients holistically and provide care that incorporates
15
Advanced Practice
Nursing Process
Step 1
Holistic client
examination &
assessment
Epidemiologic perspective
Human Biology
Environment
Life-style
Health System
Step 2
Formulation
of a clinical
diagnosis
Step 3
Developing a
plan of care
& prevention
Step 4
Ordering &
prescribing
the plan
Levels of prevention
Primary prevention
Secondary prevention
Tertiary prevention
Step 5
Evaluation
& holistic
reassessment
FIGURE 4
The holistic epidemiologic
prevention process model
for advanced practice nursing
(Developed by Kolpien-Bugaj, K. 1998)
16
health promotion through disease prevention and patient education, as well
as to diagnose and treat the disease process (Keeling, 1996). The nurse
practitioner role incorporates elements of both medicine and traditional public
health which may make it one of the best suited to combat diseases such as
chlamydia. To effectively do so requires that the most reliable assessment
tools be utilized. If the number of WBCs on Gram stain is a valid predictor for
chlamydia diagnosis, NPs could be trained to do them. If it is not a reliable
indicator, are there other clinical characteristics that could be obtained using
a holistic examination and assessment which would more reliably predict
infection? Identifying such indicators could assist the screening and
treatment of individuals with chlamydia seen in clinical practice.
Statement of the Problem
Documented cases of chlamydia occur in the United States more
frequently than any other infectious disease (CDC, 1997c). An estimated 3.5
million cases go undetected and unreported each year with consequent lack
of screening, diagnosis, and treatment largely attributed to its asymptomatic
nature. There are no consistent guidelines for the detection of chlamydia.
The testing methods most often used do not provide results at the time of the
patient’s office visit. Once a positive result is received, patient compliance
17
with treatment follow-up is often difficult to obtain.
A method for detection of chlamydia, or clinical indicators with a high
positive predictive value for infection, could facilitate immediate treatment and
improve the prevention and control of further disease. Because a
concentration of WBCs is a biologic response to inflamation, and since an
infection such as chlamydia should evoke the inflammatory response, WBCs
should be present in biologic tissues infected with chlamydia. This study
sought to answer the following research question: What relationship is there
between the presence of white blood cells on female cervical and male
urethral Gram stains, and chlamydial infection?
Assumptions
This study was based upon the following assumptions:
1. Guidelines for the diagnosis and treatment of chlamydia,
nongonococcol urethritis, and mucopurulent cervicitis, as designated by the
CDC, were valid.
2. Generally accepted performance standards had been met and
maintained by all medical and laboratory personnel who performed testing,
diagnosis, and treatment of patients at risk for chlamydia and related sexually
transmitted diseases.
3 Patient records provided accurate information regarding medical
18
history, physical examination findings, appropriate laboratory test specimens,
patient contact information, test results, medical diagnosis, and treatments
prescribed.
4. Testing supplies were uncontaminated, unexpired, and capable of
accurately assessing for the presence or absence of infection.
5. The presence of white blood cells on Gram stain was indicative
of inflammation and/or infection due to some underlying agent of pathology,
and chlamydia as an agent stimulates the presence of WBCs.
6. Untreated chlamydia could result in complicating sequelae and an
increased risk of infection with the human immunodeficiency virus, (CDC,
1997c).
7. Treatment indicated that a patient received either medication, or a
prescription for medication, approved by CDC guidelines for treatment of
chlamydia.
Definition of Terms
The succeeding terms were defined for this study as follows:
1
Chlamydia trachomatis are nonmotile, obligate, intracellular
parasites that were once thought to be viruses. They now are known to more
closely resemble bacteria because they contain both Deoxyribonucleic acid
(DNA) and ribonucleic acid (RNA) genetic material, and have a cell wall
19
similar to the one seen in Gram-negative bacteria. They are transmitted
between human hosts via the contact and exchange of infected genital body
fluids. They are generally vulnerable to specific macrolide and tetracycline
antibiotic treatments.
2. Nongonococcal urethritis is an inflammation of the urethra with an
etiology other than Neisseria gonorrhoeae or Trichomonas vaginalis (CDC,
1997a).
3. Mucopurulent cervicitis is an inflammation of the cervix with an
etiology other than Neisseria gonorrhoeae or Trichomonas vaginalis (CDC,
1997a).
4. Gram stain is a laboratory test used to look for evidence of the
presence of microorganisms by examination of the number and type of blood
and tissue cells observed, and/or the evidence of various bacteria, following a
specified staining process (Laboratory Corporation of America [Lab Corp],
1997-1998). When observed under a microscope, Gram-positive organisms
will appear blue, and Gram-negative organisms will appear red (Lennette et.
al., 1980). The test is useful for identifying the presence of Neisseria
gonorrhoeae in genital specimens due to the distinct Gram-positive diplococci
bacteria evident in gonorrhea infection. Gram stain is also a screening tool
for the presence or absence of other infections, as determined
20
by the number of polymorphonuclear (PMN) white blood cells viewed per
microscopic field (Lab Corp, 1997-1998). Because Chlamydia trachamatis is
an intracellular organism it cannot be detected on Gram stain. Therefore, the
absence of Gram-positive diplococci, and the presence of PMN-WBCs
indicate an infectious process from an agent other than Neisseria
gonorrhoeae. Because chlamydia has the highest incidence of all STDs,
WBCs on Gram stain, in the absence of Gram-positive diplococci, may be
due to chlamydial infection.
5. Transcription Mediated Amplification (TMA) is a laboratory test
utilizing a Hybridization Protection Assay method. It uses specimen DNA
probes that are acidinium ester-labeled, and specific to the target organism’s
amplified sequence. The organism is released by either chemical or
mechanical means. The TMA targets ribosomal RNA (rRNA) with the
breakdown of a single bacterial cell resulting in up to 10,000 copies of rRNA
being made. This gives the test an assay sensitivity of less than one cell (Hill,
1996).
6. White Blood Cells (WBCs) are immune cells that can kill many
pyogenic bacteria and fungi. They are a defense mechanism of the human
body, mobilized by the inflammatory response to the infection of the host by a
foreign (or biologically perceived foreign) agent (Groer & Shekleton, 1989).
21
7. A specimen is a sample from a potential host of cells, tissues, or
fluids known to act as a reservoir for an agent of disease (Fischbach, 1988).
8. A wet mount is a cervical mucous specimen added to 5-7 drops of
normal saline on a glass slide. It is covered with a coverslip and viewed
under a microscope for the presence of yeast buds or hyphae, Trichomonas
vaginalis organisms, or large WBCs known as “clue cells” present in bacterial
vaginosis (Carr, Freund, & Somani, 1995)
9. Presumptive treatment is any patient who received a CDC
approved treatment regime for chlamydia prior to the availability of results
from a laboratory test specific for chlamydia.
Limitations
This examination of the research question was limited by the following
factors:
1. The data collected had an optimum accuracy equivalent to that
which is reasonably attainable with those tests being utilized because all
available methods of testing for chlamydia can give false-negative results
(Eng & Butler, 1994).
2. Only data from one clinic site was utilized which decreases the
generalization of the results obtained to other populations and types of
medical sites.
22
3. Laboratory results were derived from male urethral or female
cervical specimens and were obtained by multiple practitioners who, while
following clinical guidelines, may still have some variability in clinical
technique.
4. Race, gender, age, and visit status as a new patient or established
patient, were all controlled for to limit bias from any of these confounding
variables.
Summary
Chlamydia is currently being reported with a greater incidence than
any other infectious disease (CDC, 1997c). It is often asymptomatic and, left
untreated, can lead to costly, complicating sequelae (CDC, 1997c). Certain
groups have been targeted by leading medical organizations for screening of
chlamydia, in an attempt to decrease its spread by utilizing principles of
epidemiology. Tests used for screening often give false-negative results, and
no consistent guidelines for screening and presumptive treatment have been
firmly established (Schachter, et. al., 1992). Knowledge of which patients to
screen, and accurate diagnosis and appropriate treatment for chlamydia, fall
within the scope of practice of nurse practitioners. With the knowledge that
white blood cells are mobilized by the immune system to the site of invasion
by foreign agents, it can be concluded that they would be
23
directed to the mucous membranes of the genital tracts of human hosts
infected by the agent of chlamydia. Patients who exhibit symptoms related to
the inflammatory response of infection, such as pain or evidence of infectious
exudate in the form of cervical or urethral discharge, would be assumed to
have white blood cells present as a part of this bodily response. But, what
about patients who have no complaint of symptoms and no clinical signs of
inflammation upon exam? Are signs and symptoms absent due to a lack of
an inflammatory response or, in a Gram stain of a specimen from the site,
would evidence of infection and inflammatory response be detectable by the
presence of white blood cells? If so, then a Gram stain with white blood cells
in the absence of any Gram-positive diplococci indicative for gonorrheal
infection, could be a valid predictor of chlamydial infection. If a lack of signs
and symptoms coincides with a lack of white blood cells on Gram stain in
patients with confirmed chlamydia infection, then it may be a poor diagnostic
indicator.
24
Chapter 2
Review of Literature
In this review of literature, studies focusing on patient screening
strategies, diagnostic laboratory tests utilized for screening, and approaches
to treatment for chlamydia have been examined. Changes in laboratory
technology and requirements, and their effect on the screening process, are
discussed. The role of the nurse practitioner in effectively screening, testing,
and treating patients for chlamydia is also reviewed.
Goals and Guidelines for Screening and Treatment.
Ideally, decreasing the incidence of sexually transmitted diseases
requires that many variables be competently addressed (Eng & Butler, 1997).
These include assessment of risk; laboratory testing and screening; physical
examination; appropriate diagnosis and treatment; partner notification and
follow-up; and patient education and counseling regarding the disease, its
method of transmission, consequences of nontreatment, and behavioral
change for future risk reduction. The degree to which these goals are met is
often directed by the availability of resources. Traditionally, assessments of
the quality of public health measures to address these variables have been
limited (Eng & Butler, 1997). In a recent report, the Institute of Medicine
found that, upon conducting on-;■site visits and in personal work with public
25
health STD clinics, that there was little emphasis placed
on quality indicators
for screening and treatment of chlamydia. Emphasis was on the number of
patients screened, not upon the number that tested positive and who were
adequately or appropriately treated (Eng & Butler, 1997). This finding
correlated with the CDC’s (1993a) recommendations for chlamydial program
evaluation. The CDC suggested that information should be gathered to
provide quantitative estimates about diseases, and follow trends. This should
include any interventions that are performed, and an evaluation of their
impact. They further recommended that such data be analyzed from an
epidemiologic perspective and be used as the basis for decisions regarding
future allocation of resources and evaluation of chlamydia prevention
programs.
In Healthy People 2000, Health Status Objective 19.2 states, “Reduce
Chlamydia trachamatis infections, as measured by a decrease in the
incidence of nongonococcal urethritis, to no more than 170 cases per
100,000 people (Baseline: 215 per 100,000 in 1988)” (HHS, 1991, pp. 498).
In it’s most recent treatment guidelines for sexually transmitted diseases, the
CDC defined nongonococcal urethritis (NGU) in men as urethral inflammation
not caused by Neisseria gonorrhoeae. The diagnosis of urethral
inflammation is based upon the presence of urethral discharge, the presence
26
of white blood cells (WBCs) on a Gram stain smear, or a positive urine
leukocyte esterase test (for any man under 60, who has no history of
urogenital diseases). A diagnosis of NGU also requires that no laboratory
evidence of N. gonorrhoeae be detected (CDC, 1997a).
Women may also get urethritis from various agents, including
chlamydia, but they are more often tested and evaluated via endocervical
specimen. The CDC defines mucopurulent cervicitis (MPC) in women as
cervical inflammation that is not the result of Neisseria gonorrhoeae or
Trichomonas vaginalis. Any mucopurulent secretion noted from the
endocervix that is yellow or green when viewed on a white cotton swab
(positive swab test) is considered diagnostically positive. In addition, any
induced endocervical bleeding that results when the swab is first introduced
into the endocervical canal is also criteria for diagnosis of MPC. Laboratory
tests must also show no evidence of either Neisseria gonorrhoeae or
Trichomonas vaginalis (CDC, 1997a).
Diagnostic Tests
In 1995, a group of researchers from the CDC performed a national
survey of STD testing sites across the United States. The purpose was to
evaluate laboratory testing being used for sexually transmitted diseases.
What Consuelo M. Beck-Sague (1996) and her colleagues discovered was
27
that, when asked what test, or tests, had been added within the past 2 years,
nonculture tests for chlamydia were most often sited by survey respondents
(34 of 81 [42%]). When asked to specify why that particular test had been
recently included at their site, the most frequent response was that of
available funding specifically targeted for chlamydia testing (25 of 81
[30.9%]), (Beck-Sague, et. al.).
Of the sites using the nonculture chlamydia tests, 51.4% reported that
they were using either enzyme immunoassays (ElAs), (55 of 254 [21.6%]),
deoxyribonucleic acid probes (nucleic acid probes or DNA probes), (51
[20.1%]), direct flourescent antibody (DFA), (20 [7.9%]), or polymerase chain
reaction (PCR), (2 [<1%]) tests (Beck-Segue, et. al., 1996). The remaining
126 of 254 (49.6%) of respondents failed to designate which nonculture test
was utilized at their site.
In the same study, when asked to list any test, or tests, that their site
had ceased using within the past 2 years, the tests most often listed were the
Gram stain or culture for gonorrhea (Beck-Sague, et. al., 1996). The number
of facilities that performed stat Gram stains decreased from 170 in 1992 to
111 by the time of this study's 1994 survey (Beck-Sague, et. al.). When
asked the reason for dropping that particular test, 91.9% of respondents cited
their inability to comply with the more
stringent requirements implemented by
28
the Clinical Laboratory Improvement Act as the reason for the discontinuation
(Beck-Sague et. al.).
Another test for chlamydia, which was not mentioned at all in the study
by Beck-Segue et. al., (1996), is the ligase chain reaction (LOR) urine test. A
study performed at Johns Hopkins University (Gaydos et. al., 1995),
compared the sensitivity and specificity of the LCR to the EIA for chlamydia.
Their results showed the LCR to be both highly sensitive (100% for males
and 100% for females tested) and specific (99.6% for men and 98.5% for
women) in its detection of chlamydia. By comparison, the EIA was found to
be far less sensitive (10% for men and 15.2% for women); its specificity was
also less, but not as dramatically ( 99.6% for men and 98.9% in women),
(Gaydos et. al.). The LCR is still a relatively new test. It is a more expensive
test than the other methods currently available and, therefore, not yet as
widely used (Gaydos et. al.). To perform this test, urine specimens need to
be centrifuged, then supernatant aspirated by pipet and a urine buffer added.
This mixture is then heated to 100°C, cooled, frozen and shipped to a
research laboratory. There, a probe amplification of the chlamydial DNA is
performed by target-dependent ligation of complementary oligonucleotide
probes by DNA ligase, after they have annealed to the gene target sequence.
The specimens are then thermocycled after being added to hapten-
29
conjugated probes, buffer, and ligase, the thermostable enzyme. Once
thermocycling is completed, amplified chlamydial DNA is detected by using
an automated EIA test.
Part of the problem in effectively combating chlamydia is the fact that
there is no test for chlamydia which has been established as the “gold
standard” (Schachter et. al., 1992). Newer nonculture tests for chlamydia
have been developed with sensitivities and specificities exceeding those of
the chlamydia culture. Schachter and colleagues concluded that due to the
variety of tests that are available, and the characteristics of chlamydia, there
is a need for a comprehensive control program that sets criteria for diagnosis
and treatment of both symptomatic and asymptomatic individuals.
Screening Characteristics
Although high risk women are often screened through routine health
care sought for birth control or illness, women with chlamydia are more likely
to be asymptomatic (75%) than are men (50%) (CDC, 1997c). Conversely,
CDC research found that although men may more often be symptomatic,
they often have fewer screening opportunities. In one study of untreated,
symptomatic heterosexual men, 45% spontaneously became asymptomatic
within 1 month of testing (Rietmeijer, Judson, Boele Van Hensbroek, Ehret, &
Douglas, 1991). This lead the researchers to conclude that, while there has
30
been less attention to screening and follow-up of men in the past, it may be
worth increasing emphasis on men, as an indirect means of lowering the
incidence of chlamydia infection in women.
In a total of over 4500 clinic visits, Rietmeijer et. al. (1991) found that
42% of the men met the traditional treatment criteria for chlamydia. Twenty
seven percent were diagnosed with NGU based upon the presence of
> 4 PMN/HPF on Gram stain. There were 11% who were treated because of
their diagnosis of gonorrhea and almost 4% who had had sexual contact with
a female partner who had been diagnosed with, or was suspected of having,
chlamydia. Men who remained asymptomatic comprised almost 41% of the
total. The final 17% presented with complaints consistent with urethritis, but
were not diagnosed or treated because they had not met any of the above
criteria (Reitmeijer et. al., 1991). The results revealed that using the 1989
screening and testing recommendations of the CDC had failed to detect and
promote treatment in 23.4% of the infected population. Table 1 contains the
data from this Reitmeijer et. al. study.
In an attempt to increase the sensitivity of the Gram stain as a
screening tool, Rietmeijer et. al. (1991) used successively decreasing
numbers of PMNs, down to a low of > 1 PMN/HPF, as the criteria for
diagnosis of NGU. Even at that lowest level, they found that 45% of
31
Table 1
Chlamydial Infection in Heterosexual Men in a Study Reported by Rietmeijer et. al.
(1991).
Diagnostic Category
Infected with Gonorrhea
Total Tested
Total Positive
n
(%)
n
(%)
516
(11-0)
62
(8-1)
1266 (27.0)
494
(64.9)
179
(3.8)
27
(3-5)
803
(17.1)
52
(6.8)
Infected with NGU by > 4
PMN/HPF on Gram Stain
Contact to Infected Partner
Symptomatic but without
Objective Evidence
Asymptomatic
1917 (40.9)
126
(16.6)
Total
4681
761
(100.0)
(100.0)
Note. NGU=Nongonococcal Urethritis, PMN=Polymorphonucleocyte, HPF=High Power
Field.
32
infections still would have been missed by the Gram stain. Based upon this
finding, these researchers concluded that the best method for detecting
chlamydial infection and the need for treatment at the time of the initial clinic
visit is not clear. They further indicated that additional research is needed to
determine the most effective, expedient, and economic approach towards
maximizing treatment at initial patient visits (Rietmeijer et. al., 1991).
Another group of researchers did a comparison of overall STD testing
results for men with and without presenting symptoms (Janier et. al., 1995).
They utilized Gram stain, but with >5 PMN/HPF as the cut-off criteria for
diagnosis of NGU (Table 2).
In their conclusions, Janier et. al. (1995) emphasized the low
sensitivity that a Gram stain smear had for indicating chlamydial infection in
patients who reported no symptoms. They also pointed out that even in
patients with symptoms, the sensitivity of the Gram stain was still only 86%.
They concluded that every patient who presents with urethral symptoms
should have a PGR for chlamydia performed, regardless of whether
discharge is noted or PMNs are present on Gram stain. They noted that
when discharge was present, Gram stain remained a valuable tool for the
exclusion of N. gonorrhoeae.
33
Table 2
Gram Stain Urethral Smear Results in 219 Men With and Without Urethral Discharge from
a Study Reported by Janier et. al. (1995).
With Discharge (n=122)
Pathogen Category
Without Discharge (n=97)
Smear +
Smear -
Smear+
Smear -
n
(%)
n
(%)
n
(%)
n
(%)
Chlamydia
18
(19)
3
(11)
2
(7)
5
(7)
Gonorrhea
23
(24)
2
(8)
0
(0)
0
(0)
Ureaplasma
9
(9)
3
(11)
1
(4)
2
(3)
Mycoplasma
25
(26)
4
(15)
4
(15)
4
(6)
Trichomonas
3
(3)
0
(0)
0
(0)
Indeterminate results
7
7
23
0
(0)
23
Patients with > 1
67
(70)
12
(46)
7
(26)
11
(16)
Pathogens
9
(9)
6
(23)
7
(26)
23
(33)
No Pathogen
20
(21)
8
(31)
13
(48)
36
(51)
Total Patients
96
Pathogen
Patients with Only
Indeterminate
26
27
70
34
Treatment Characteristics.
Once a patient has completed the screening and testing processes,
the question of treatment arises. In a recent study, clinical records covering
an 18 month period from over 35,000 patients of a county health department
STD clinic were reexamined (Schwebke et. al., 1997). This study was one of
the first to question how many patients with positive test results were actually
treated.
Treatment Before Test Results. The study by Schwebke et. al. (1997)
revealed that only 1% of men who had positive cultures for gonorrhea had not
been treated at their initial clinic visit, while the rate of untreated chlamydia at
initial visit was 11%. For women, the rates were 12% and 44%, respectively.
Of all the patients who reported no symptoms at their initial clinic visit, and left
without receiving any kind of treatment, 12% had tests that showed they were
infected with N. gonorrhoeae and 44% had tests showing they were infected
with chlamydia. This rate was only 1% below the 45% failure rate of Gram
stain screening that was found by Rietmeijer et. al. (1991).
In the same study, Schwebke et. al. (1997) also discovered that
screening detection rates for women were higher than for men. Patients’
charts from an STD clinic were reviewed for a designated 18 month interval.
35
The numbers of patients who tested positive for gonorrhea and chlamydia
were compared to those who received presumptive treatment for these
infections. They found that chlamydia went untreated at a much higher rate
than did gonorrhea, and that women were more likely to go untreated than
were men (Table 3).
Treatment After Test Results. Once notified of infection, 20% of
patients in the Schwebke et. al. (1997) study had not returned for treatment
30 days later. An additional 30% who returned to be treated did not do so
until 2 or more weeks after their initial visit (Table 3). From an epidemiologic
perspective, this 2 or more weeks of untreated time was viewed as a
facilitator of disease spread due to the characteristics of the sexual practices
among high risk populations. It allowed others to become infected by those
who never returned for treatment, or during the 2-week interval between the
visits of those who did return.
With the discovery that high screening numbers did not assure
treatment of patients who tested positive, Schwebke et. al. (1997) suggested
that future emphasis needs to be placed on evaluating and identifying the
best indicators for initial visit treatment. They further concluded that failing to
treat patients deemed infected nullifies the value of the screening process.
Based upon the constructs of epidemiology, Schwebke et. al. (1997)
36
Table 3
Patients With Positive Screening Tests Who Were Not Treated at Initial Visit, and Time
Intervals Until Treatment Was Received, in a Study of 24,823 patients by Schwebke et.
al. (1997).
Patients
No Treatment
Treatment
Within 30 Days
Treatment
In < 13 Days
In 14-30 Days
n / total
(%)
n / total
(%)
n / total
(%)
GC
95 / 530
(18)
286 / 530
(54)
149/530
(28)
CT
125/634
(20)
286 / 634
(45)
223 / 634
(35)
GC
20/34
(59)
8/34
(23)
6/34
(18)
CT
11/43
(26)
20/43
(46)
12/43
(28)
GC
115/564
(20)
294 / 564
(52)
155/564
(28)
CT
136/677
(20)
306 / 677
(45)
235 / 677
(35)
Females
Males
Totals
Note. GC=gonorrhea, CT=chlamydia.
37
concluded that one method of increased treatment compliance among
infected individuals may be through direct observation therapy, fashioned
after the tuberculosis model for treatment, and by utilizing single-dose
therapy. They further determined that the data from their study had important
implications for future efforts to control and prevent sexually transmitted
diseases.
In the studies previously sited, Rietmeijer et. al. (1991) studied only
Gram stain as it applied to men; Schwebke, et. al. (1997) found that
screening cultures for both gonorrhea and chlamydia detected infection in
women far more often than in men. Neither of these studies looked at Gram
stain as a screening tool for women. This researcher found no data on
women for comparison to the data Rietmeijer et. al. collected for men. If
other indicators of chlamydial infection that occur simultaneously with positive
Gram stain in women can be identified, they could facilitate future criteria for
chlamydia treatment in the private health sector.
Beck-Segue et. al. (1996) found that most primary care settings did not
have the capability to maintain the requirements necessary for a laboratory
certified to perform Gram stains. They also identified the fact that, while
screening numbers and positive tests in private sector offices may be far
fewer than in large public clinics, their role or value in the total picture of
38
combating STDs is still important.
Nurse Practitioner Role
As nurse practitioners (NPs) become more common in primary care
offices, they will increasingly be in settings where on-site laboratory facilities
may be less accessible than in the past. A national survey sought to examine
NPs’ knowledge levels and treatment practices concerning chlamydia in their
female patients (Alexander, Treiman, & Clarke, 1996). Of over 1600
questionnaires mailed, a response rate of 38% was obtained resulting in over
600 respondents.
Of those, 49% identified their work site as a family
planning or public health clinic. Overall, 88% of respondents had a scope of
practice which included family planning, STDs, or gynecology. This study
revealed that chlamydia was the most common STD identified in the tests of
their patients. Fifty-five percent felt “very knowledgeable” and 40%
“knowledgeable” about STDs, while 60% to 80% answered questions
regarding chlamydia accurately. The only NP knowledge deficits identified
by the study were related to appropriate screening and treatment of pregnant
patients with chlamydia (Alexander et. al., 1996).
When questioned about the type of diagnostic testing their facility
utilized, 72% of the NPs reported that tests were performed at an off-site
laboratory (Alexander et. al., 1996). The types of tests varied, with enzyme
39
immunoassay (EI A), direct flourescent antibody (DFA), nucleic acid
hybridization (DNA), and culture all being named. Only 3% reported use of a
rapid diagnostic test, which takes less than 30 minutes for on-site results.
This study echoed previous ones by Schachter et. al. (1992) and Janier et. al.
(1995) by declaring that “no single test has yet emerged as simple,
noninvasive, inexpensive, specific and sensitive” (p. 51).
The most frequently cited reason for delayed or absent treatment, was
the lag time between the screening tests and the availability of the results
(Alexander, et. al., 1996). The rates of presumptive treatment reported in the
survey were compared to the current CDC guidelines (Table 4).
Of all the survey treatment scenarios, patients were most likely to be
presumptively treated for chlamydia (by 93% of the NPs) when they reported
a sex partner infected with chlamydia (Alexander et. al., 1996). Conversely,
they were least likely to be presumptively treated for chlamydia (by only 39%
of the NPs) if they reported that a sex partner had acute urethral syndrome.
Of all of the patients who did receive presumptive treatment reported in the
survey, 24% of the nonpregnant and 34% of pregnant patients received either
inappropriate or inadequate treatment according to the CDC guidelines.
These data, obtained from NPs working predominantly (88%) in family
planning, STD, and gynecology settings, reinforce the need for more
40
Table 4
Criteria For Presumptive Treatment for Chlamydia as Reported by Nurse
Practitioners in a Survey Performed by Alexander et. al, (1996).
Treatment Circumstance
NPs (n=611)
Patient says partner has CT*
93%
Patient has signs and systems of PID*
88%
Patient has MPC**
84%
Patient says partner has NGU
72%
Patient says partner has GC*
68%
Patient has signs / symptoms of GC*
66%
Wet prep shows high WBC count
61%
Patient says partner has epididymitis
40%
Patient has acute urethral syndrome**
39%
Never presumptively treat
0%
Notes. ‘Conditions which indicate presumptive treatment based upon CDC
recommendations. **Conditions which may indicate presumptive treatment
depending upon other risk factors, based upon CDC recommendations.
CT=Chlamydia, GC=Gonorrhea, PID=Pelvic Inflammatory Disease, MPC=Mucopurulent
Cervicitis, NGU=Nongonococcal Urethritis, NP=Nurse
Practitioner, WBC=White Blood Cell.
41
specific guidelines and criteria regarding which patients to screen, what tests
to use, and whom to treat.
Is this study reflective of all NPs, or would the knowledge level and
treatment deficits of NPs who work in family practice differ at all from those
whose practice is primarily with women, reproduction, and public health? If
NPs must play a role in the fight against chlamydia and its sequelae, what
screening criteria, and testing data will best equip them? What role, if any,
could use of Gram stain play in screening and presumptive treatment for
chlamydia? Alexander et. al. (1996) concluded that nurse practitioners do
need continuing education to perform adequate management of all sexually
transmitted diseases within their patient populations.
Summary
The literature supports the application of the Epidemiologic Model with
regard to chlamydial infection and barriers to its successful control. The
“host” factors of variances between men and women, pregnant versus
nonpregnant, symptomatic versus asymptomatic, have been examined.
Characteristics of the “agent” that promote the of spread of chlamydia, while
simultaneously making development of a single reliable test difficult, have
also been reviewed. The “environment” has been viewed by factors such as
a social climate of risk and noncompliance, a biologic risk from other STD
42
co-infections which may be present, or as physical risks where results of tests
simply are not available on-site or in a timely manner. All of these
epidemiologic factors have been reviewed in an attempt to learn what can be
done differently, in a better attempt to control chlamydial infection. Gram
stain has been identified as one component within the matrix of chlamydia
control.
In this review of literature, studies that identified the lack of current,
consistent guidelines for screening and treatment of chlamydia, were
examined. Various diagnostic testing methods, and comparisons of their
effectiveness, have been mentioned. Screening methods and criteria for
presumptive treatment, as well as lack of treatment and difficulty of patient
compliance, have also been reviewed. The role of the nurse practitioner in
the screening, testing, and treatment of chlamydia was discussed because
their increasing numbers as primary care providers necessitate adequate
knowledge for management and control of all sexually transmitted diseases,
including chlamydia.
Because of the holistic approach that nurse practitioners bring to
primary care, they are well equipped to focus on the epidemiology of
chlamydia control and may be able to serve as a bridge between the medical
and public health communities. This could result in a positive impact on
43
chlamydia control efforts.
44
Chapter 3
Methodology
If presumptive gonorrheal infection can be ruled out using a Gram
stain, but white blood cells (WBCs) are still present, perhaps their presence is
due to chlamydial infection. If their presence is a reliable positive predictor of
patients infected with chlamydia, even in the absence of signs or symptoms,
utilizing Gram stain would be a relatively simple, inexpensive, and immediate
test for infection. These are all attributes of a desirable screening or
diagnostic test for chlamydia. However, since the Gram stain may identify
WBCs associated with conditions other than chlamydia, it is not a specific
test. This chapter presents the hypothesis, operational definitions, research
design, procedures, sample, informed consent, instrumentation, and data
analysis that were utilized to execute this study.
Hypothesis
Patients with chlamydia infection will have white blood cells on Gram
stain with or without clinical signs or symptoms. White blood cells on Gram
stain, in patients with or without clinical signs or symptoms, will not empirically
indicate chlamydia infection.
Operational Definitions
The following terms were operationally defined for this study.
45
1. White blood cells (WBCs) refer to polymorphonuclear (PMN) white
blood cells, as identified by Gram stain laboratory testing.
2. Nongonococcal urethritis (NGU), a diagnosis for any male patient,
is defined by a Gram stain smear without Gram positive diplococci indicative
of gonorrhea that exhibits > 5 WBCs per oil immersion field (oim) (CDC,
1993b).
3. Mucopurulent cervicitis (MPC), a diagnosis for any female patient,
is defined by a Gram stain smear without Gram positive diplococci indicative
of gonorrhea that exhibits >10 WBC/oim (CDC, 1993b).
4. Chlamydial infection or chlamydia refers to genital Chlamydia
trachamatis infection of adults and adolescents who have sought testing and
treatment, and who were tested using transcription mediated amplification
(TMA) obtained via male urethral or female cervical DNA probes.
5. Gram stain refers to either a male urethral or female cervical slide
smear prepared as follows: After the slide is fixed by heating with a flame, it
is flooded with a crystal violet solution which is left on for 1 minute. It is
washed briefly with tap water, and drained. It is then flooded with iodine
which is allowed to stand for 1 minute. It is then washed with tap water
again. Next it is decolorized with a mixture of 95% ethyl alcohol and 5%
acetone, until it runs clear. The slide is then counterstained with safranine
46
for 10 seconds, washed with tap water, and blotted dry (C. Cancilla, personal
communication, November 12, 1997).
Research Design
This study was conducted utilizing a quantitative, matched groups
design. It was implemented through a retrospective examination of clinical
patients’ charts from the Erie County, PA Health Department’s sexually
transmitted diseases (STD) clinic.
Procedures
Charts of patients seen in clinics conducted over a 6 month time
period from July 1, 1997 through December 31, 1997, were reviewed. These
months were chosen to coincide with the health department’s contracts for
the chlamydia test method, and laboratory analysis of the tests, both of which
began on July 1, 1997.
Only those charts indicating that a nurse assigned to the STD division
saw the patient and obtained the specimens fortesting, were considered.
Any records indicating that nurses from another division obtained the clinical
data were excluded due to what could be a lower level of experience and
proficiency.
The data to be examined were from patients who presented during
sessions consistently staffed by one physician who had extensive experience
M
with STD patients. Additionally, the same laboratory technician was also
present and had experience performing Gram stains.
Sample
The sample of 54 patients was derived from the population of patients
who sought testing and treatment for STDs over a six month period in 1997,
at the Erie County, PA Health Department. A second case control sample
matched by race, gender, age, and clinic status as either a new patient or
established patient, was chosen from the same population and same six
month time period. Patients were included regardless of race, sex, religion,
ethnicity, age, income, or health insurance status. Permission for use of the
sample population data was obtained utilizing a written Access to Protected
Data contract between the researcher and the Erie County Department of
Public Health (Appendix A). It was completed according to the standards set
by the Division of Health Statistics, Pennsylvania Department of Health,
User’s Guide for Access to Protected Data (Appendix B). All patients signed
a dated written consent for testing and treatment (Appendix C).
The patients were referred to by an assigned clinic number whenever
addressed outside of a clinic room. They were assured of confidentiality and
were not required to produce any type of identification. No billing was
conducted, so no insurance cards or social security information was
48
obtained. Although a patient’s address and phone number were recorded, if
patients requested no calls or mail, they were not contacted unless there was
an emergency.
Prior to leaving the clinic, patients were issued a code number to use if
they called the clinic in regards to their visit or to obtain any test results. If
they called without the number, no information was given until they appeared
in person and produced identification. This prevented parents, sex partners,
spouses, friends, or any other medical establishment from accessing
information without written consent. Medical information from charts was
never sent over a FAX, unless a clear threat to the patient’s life or well-being
had been established and the patient’s permission to release information
had been received.
From the population of patients as described, seen within the
designated time period for this study, two matched sample groups were
chosen for inclusion. The first group was comprised of any patient who
tested positive for chlamydia. The second was comprised of patients who
tested negative for chlamydia. The groups were matched for age, gender,
race, and whether they were first time attenders to the STD clinic, or had
been seen on previous visits in the past.
49
Informed Consent
Due to the security, anonymity, and confidentiality regarding all patient
clinical records, any follow-up contact with patients regarding the information
reviewed for this study was prohibited by the policies and procedures of the
health department’s medical division. Because individuals whose chart
information was utilized were never identified, informed consents from the
patients whose records were reviewed, were not required fortheir inclusion in
the study. The Access to Protected Data included consent to utilize the
records in a confidential manner on-site, with the agreement that no
identifying information be recorded or utilized in the study.
Instrumentation
In accordance with the study design a spreadsheet was used to record
the data from each patient’s chart (Appendix D). The following data were
collected:
1. Demographic Characteristics . The age, gender, race, and the
patient’s status as a “first visit” or “established patient” were recorded.
2. Independent Variables. Several independent variables were
recorded and included:
a. Was there a patient complaint of urethral or vaginal discharge?
b. Were any signs of urethral or cervical discharge recorded by the
50
nurse who performed the patient’s examination and testing?
c. Was urethral or cervical bleeding recorded by the nurse when the
test specimen was obtained?
d. The results of the Gram stain to include: 1) Gram-positive
diplococci, indicating gonorrheal infection, 2) WBCs sufficient to meet criteria
for diagnosis of NGU or MPC, 3) the presence of both Gram-positive
diplococci and WBCs sufficient to meet the criteria for diagnosis of NGU or
MPC and gonorrhea.
e. Wet mount results (female patients only), for detection of: 1) yeast,
2) Trichomonas, 3) clue cells indicative of bacterial vaginosis.
f. Any medications prescribed for the presumptive treatment of
chlamydia on the date of the clinic visit.
g. Whether the patient returned for chlamydia treatment at a later date.
h. The nurse who performed the examination and testing.
3. Dependent Variable
Results of any laboratory tests sent to an off-site lab for Transcription
Mediated Amplification (TMA) chlamydia and gonorrhea testing:
a. TMA/DNA probe gonorrhea result.
b. TMA/DNA probe chlamydia result.
51
Data Analysis
The data from each patient’s chart were tabulated utilizing the
Statistical Package for Social Scientists (SPSS) for Windows Base System
User’s Guide Release 6.0 version. They were statistically analyzed using
frequency tables, and T-tests for continuous variables. Pearson uncorrected
chi square analysis and Fisher’s two-tailed test were used for categorical
variables. Differences between groups were considered statistically
significant if P< 0.05. These statistical analyses were then reviewed as a
basis for either accepting or rejecting the hypothesis of the study.
Summary
This chapter has outlined the methods of the study. The hypothesis
was defined and the operational definitions, the research design, and
procedures to be used in the testing of the hypothesis were detailed. The
sample was discussed, as was the instrumentation used for data collection,
and the statistical analysis of the data.
52
Chapter 4
Results
In this chapter, the statistical analysis of the data collected from 54
patient charts are discussed. It includes comparisons of clinical indicators
and Gram stain results to DNA probe results. Additionally, a comparison of
gonorrhea and chlamydia results are reviewed.
Demographic Data
There were 22 (40.7%) white and 32 (59.3%) black patients included
in the study. Thirty-six (66.7%) were male and 18 (33.3%) were female.
Patients who had been to the clinic on at least one other occasion numbered
12 (22.2%), while those who were there for the first time were 42 (77.8%).
The mean age of the clients was 19.6 years, with a range from 16 to 30 years
of age. However, 36 (66.6%) of the 54 patients included in the study were
aged 16 to 19 years (Table 5).
Clinical Indicators and DNA Probe Chlamydia Results
The results of the Gram stains for WBCs and the DNA probes for
chlamydia did show a statistically significant relationship (P=0.00014). These
results and those of the other clinical indicators examined, and their
corresponding DNA test results are shown in Table 6. Thirty-seven (69%) of
the 54 patients were diagnosed with either nonspecific cervicitis (NSC) or
53
Table 5
Demographic Data for Study Sample Groups
Patients
Chlamydia Positive
Chlamydia Negative
n=27
n=27
18
18
9
9
White
11
11
Black
16
16
Age 16-19
18
18
Age 20 - 30
8
8
Age > 30
1
1
21
21
6
6
Males
Females
First patient visit
Established patient
54
Table 6
DNA Probe Chlamydia Results and Results of Other Clinical Indicators in Patients From the STD Clinic in
This Study.
DNA Probe Chlamydia +
DNA Probe Chlamydia -
P (chi-squared
n=27 No.(%)
n=27 No.(%)
Patients
Yes
No
Yes
No
Totals
27
0
27
0
25(93) 2(7)
12(44)
15(55)
P=0.00014
Patient Reports Discharge
10(37)
17(63)
10(37) 17(63)
P=1.0 NS
Gram+ Diplococci on GS
5(19)
22(81)
5(19)
22(81)
P=1.0 NS
14(52)
13(48)
P=0.09087 NS
6(22)
21(78)
P=0.75026 NS
test)**
WBCs on GS
Diagnosed as NSC/NGU
Nurse Reported Discharge
Observed on Exam
20(74) 7(26)
20(74)
DNA+ for Gonorrhea
7(26)
First Visit to the Clinic
20(74) 7(26)
22(81) 5(19)
P=0.51269 NS
Note. DNA Deoxyribonucleic acid, GS=Gram stain, NSC=Nonspecific cervicitis, NGU=Nongonococcal
urethritis, WBCs=White blood cells. **P=The probability as computed by using the Pearson chi square two-
tailed level of significance value < 0.05.
55
nongonococcal urethritis (NGU) based upon their Gram stain results. All of
them were presumptively treated for chlamydia except for one, whose results
were inadvertently misinterpreted by the physician. One patient was not
diagnosed with NSC or NGU but was treated presumptively for chlamydia
based upon sexual contact to a partner infected with chlamydia.
Ten
patients (19%) had Gram-positive diplococci present on the Gram stain and
were presumptively diagnosed with gonorrhea as a result. All ten of these
also had white blood cells (WBCs) sufficient on Gram stain to be diagnosed
with either NSC or NGU. They were treated for chlamydia based upon either
of those criteria as, designated by the Centers for Disease Control and
Prevention treatment guidelines (CDC, 1993b).
When the laboratory results of the DNA probes were received they
revealed that 13 patients (24%) had been treated presumptively for
chlamydia who tested negative for chlamydia by DNA probe. Conversely,
only two patients (<1%) without sufficient WBCs on Gram stain had positive
chlamydia results. Of the ten patients diagnosed with gonorrhea based upon
the Gram stain, five (9%) had DNA probe results positive for gonorrhea, while
the remaining five had negative results.
Two patients who had no Gram-positive diplococci, but did have
WBCs on Gram stain, had DNA probe results positive for both gonorrhea and
56
chlamydia. Two patients had WBCs and Trichomonas when initially seen but
were also DNA-positive for chlamydia. One patient had yeast, Gram-positive
diplococci, and WBCs all present when first seen with a DNA probe positive
for both chlamydia and gonorrhea.
Gram Stain Versus Other Clinical Indicators
Comparing other data to Gram stain as indicators for chlamydia
infection revealed that 20 (37%) of the 54 patients complained of either a
vaginal or urethral discharge. Of these, ten (19%) were chlamydia-positive
and the other ten were chlamydia-negative (P=1.0), from study totals of 27
chlamydia-positive and 27 chlamydia-negative patients. When clinical data
recorded by the nurses who performed the physical examinations and testing
were compared, they reported that discharge was observed from 19 (35%) of
the patients who also exhibited WBCs on gram stain and were subsequently
DNA-positive for chlamydia. One patient who had discharge recorded, as
observed by the nurse who performed the exam, did not exhibit WBCs on the
Gram stain, but had DNA results positive for chlamydia. The nurses were
able to identify 20 of 27 (74%) of the patients infected with chlamydia in
comparison to the Gram stain identifying 25 of 27 ([93%] P=0.09).
Where the WBCs on Gram stain indicated presumptive treatment of
chlamydia in 12 of 27 (44%) patients who tested DNA probe negative, the
57
nurses observed urethral or cervical discharge in 14 of 27 (52%) patients who
tested DNA probe chlamydia negative. In patients not observed to have any
discharge the nurses missed 7 of 27 (26%) patients who tested
DNA-positive, while the absence of WBCs on Gram stain missed just 2 of 27
(7%) positive patients.
Gonorrhea Versus Chlamydia Results
Overall, there were 8 patients the nurses reported as having no
discharge who had WBCs on the Gram stain. Six of these were DNApositive for chlamydia and 2 were DNA-positive for gonorrhea. Both of the
patients reported by the nurses as having no discharge, who later were
confirmed to have gonorrhea by the DNA probe, had also both lacked
Gram-positive diplococci on the Gram stain. In contrast to the two patients
who were chlamydia-positive but exhibited no WBCs on the Gram stain, all
ten of the patients who tested positive for gonorrhea also were positive for
WBCs on the Gram stain, even in the two cases where the Gram-positive
diplococci were absent.
None of the other clinical indicators were statistically significant in this
study besides the relationship between Gram stain WBCs and DNA probe
chlamydia results. Due to possible interrelations between the other clinical
factors there may be other relationships present that, if isolated, would be
58
clinically and statistically significant to chlamydia infection.
59
Chapter 5
Discussion
The relationship between the presence of white blood cells (WBCs) on
Gram stain and chlamydia infection was studied in 54 patients who attended
a public health clinic for sexually transmitted diseases (STDs). Other clinical
indicators were also examined for their relationship to chlamydia. Although a
relationship between the Gram stain and DNA chlamydia results was found,
the presence of multiple other infections within both the sample groups made
other relationships difficult to isolate. This chapter will review conclusions
that were drawn and recommendations for future studies that may provide a
clearer look at other clinical indicators for chlamydia.
Conclusions
A Gram stain with an absence of WBCs had a higher predictive value
of a DNA chlamydia-negative test than did a Gram stain with the presence of
WBCs of a DNA chlamydia-positive test. This supports the research
hypothesis being studied. The Centers for Disease Control and Prevention
give criteria for presumptive treatment for chlamydia (CDC 1993b). The data
of this study support the literature with the conclusion that there is no clear
indicator concerning which patients may be infected with chlamydia, and
60
which ones are not. Two patients infected with chlamydia left the clinic
without medicine to treat it, based upon their Gram stain results. Conversely,
there were twelve patients given medication for chlamydia based on their
Gram stains, who didn’t need it because they were actually chlamydia-
negative.
When compared to the other indicators for infection that were
collected, no others were more accurate than the WBCs on Gram stain in
predicting which patients might be infected. Urethral or cervical discharge
observed by the examining nurse was the closest, but 14 patients (26%) with
observed discharge tested DNA-negative for chlamydia, and seven patients
(13%) without observed discharge tested DNA-positive for chlamydia.
Therefore, the nurses’ observations were not consistent as positive predictors
of chlamydial infection. However, of the 54 patient charts reviewed, there
were only three patients with discharge observed by the nurse who did not
test positive for some type of genital infection and, if studied further may hold
statistical significance. One of these three had already tested positive for
chlamydia at another facility, and one had a sexual partner infected with
gonorrhea.
Since all ten patients who were DNA-positive for gonorrhea had
WBCs on Gram stain (including the two who lacked any Gram-positive
61
diplococci), in this study the WBCs had a higher positive predictive value for
gonorrheal infection than did the presence of Gram-positive diplococci, even
though preliminary diagnosis of gonorrhea was based upon the diplococci,
not the WBCs being present. Since one-half of those patients with gonorrhea
also had chlamydia, it isn’t clear which infection was more or less directly
associated with the WBCs present.
In the study by Janier et. al. (1995), urethral smears had a sensitivity
of 86% for detection of chlamydia in patients with discharge. Comparatively,
the data collected in this study had a sensitivity of 68%. The research by
Janier et. al. and others that studied the indications of WBCs on Gram stain,
have only looked at men. This study included both men and women. It is not
clear what differences this may have made in the overall results obtained, but
since women with yeast, Trichomonas, and gonorrhea were all identified and
any of the three can cause discharge, part of the answer may lie here.
Recommendations
Due to the small sample size, generalizations cannot be readily made
from the data which were obtained. Some interesting questions for future
research, however, are raised. Although this study sought to examine testing
for chlamydia, one of the most interesting findings was that all patients who
tested DNA-positive for gonorrhea had WBCs present on the Gram stain,
62
while two were lacking the Gram-positive diplococci traditionally used as the
Gram stain criteria for preliminary gonorrhea diagnosis. A study comparing
the WBCs and Gram-positive diplococci for gonorrhea infection is a possible
indication for future research. Additionally, while the nurses’ reports of
discharge in patients was not as reliable as the Gram stain in predicting
chlamydial infection, it was clearly more predictable than the report of
discharge by the patients. Due to the multiple possible pathogens with which
patients may be infected, it is likely that some patients the nurses reported as
having discharge may well have had pathogens other than chlamydia as the
source. A future study which used a sample population of patients found to
be infected with chlamydia only may be a more specific method of assessing
the value of both WBCs on Gram stain, and nurses reports of discharge, as
chlamydial indicators. Due to the physiological differences between men and
women, and the effects these differences may play in the biological
manifestations of infection, studying the relationship of WBCs and discharge
to chlamydial infection may be better carried out in studies that examine just
men or just women.
This study does show that in the interests of public health, and the
control of the spread of chlamydia, the presence of WBCs on the Gram stain,
and the presence of either urethral or cervical discharge, are both strong
63
enough indicators of infection to treat the patient presumptively. In a private
practice where Gram stain is likely to be unavailable, signs of discharge
indicative of infection warrant treatment. If wet mount for females is available
and is free from Trichomonas, yeast, and clue cells, the presence of WBCs
may be an indicator of either a chlamydial or gonorrhea infection. Research
to correlate WBCs from Gram stain to wet mount could be valuable in
assessing the wet mount as a tool for detection of these two infections.
With medications such as azithromycin now available for single-dose
therapy for both gonorrhea and chlamydia, and with the health maintenance
organizations (HMOs) putting pressure on primary care providers to reduce
costs, treating patients who have observable discharge or who exhibit signs
of infection using a wet mount, may well be more efficacious than the cost of
DNA tests. Using a 2 gram dose of azithromycin would effectively treat both
gonorrhea and chlamydia in a single dose not only eliminating the cost of the
DNA testing, but also the wait which often results in treatment failure, or the
opportunity for disease spread in the interim.
64
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of nurse practitioner chlamydia knowledge and treatment practices of female
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Beck-Sague, C. M., Cordts, J. R., Brown, K., Larsen, S. A., Black, C.
M., Knapp, J. S., Ridderhof, J. C., Barnes, F. G., & Morse, S. A. (1996).
Laboratory diagnosis of sexually transmitted diseases in facilities within the
United States. Sexually Transmitted Diseases, 23, 342-349.
Carr, P. L., Freund, K. M., & Somani, S. (1995). The medical care of
women. Philadelphia: W. B. Saunders Company.
Centers for Disease Control and Prevention (1993a).
Recommendations for the prevention and management of Chlamydia
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41.
Centers for Disease Control and Prevention (1993b). 1993 Sexually
transmitted diseases treatment guidelines. Morbidity and Mortality Weekly
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Centers for Disease Control and Prevention (1996a). What we have
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Centers for Disease Control and Prevention (1996b). 1996 (October)
annual report. Atlanta: Author.
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Centers for Disease Control and Prevention (1997a). Case
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Morbidity and Mortality Weekly Review 46 (RR-10), 1 -38.
Centers for Disease Control and Prevention (1997c). Chlamydia
screening and treatment programs for young women. Atlanta: Author.
Centers for Disease Control and Prevention (1997d). 1997 (October)
annual report. Atlanta: Author.
Centers for Disease Control and Prevention (1997e). Provisional
cases of selected notifiable diseases, United States. Morbidity and Mortality
Weekly Report 46 (40), 954-955.
Chinn, P. L., & Kramer, M. K. (1995). Theory and nursing: A
systematic approach (4lh ed.). St. Louis: Mosby-Year Book, Inc.
Clark, M. J. (1992). Nursing in the community. Norwalk, CT:
Appleton & Lange.
Commonwealth of Pennsylvania Department of Health (1970).
History of V. D. (Schwartz, W. F., H502.510P, 4/70). Atlanta, GA:
Communicable Disease Center, U. S. Department of Health, Education and
Welfare.
Eliot, T. S. (1943). Four guartets. New York: Harcourt, Brace &
World, Inc.
Eng, T. R., & Butler, W. T. (Eds.) (1997). The hidden epidemic:
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Confronting sexually transmitted diseases. Washington, DC: National
Academy Press.
Erie County Department of Health (1997). Communicable disease
statistics. Erie, PA: Author.
Fischbach, F. (1988). A manual of laboratory diagnostic tests.
Philadelphia: J. B. Lippincott Company.
Gaydos, C. A., Ngeow, Y. F., Lee, H. H., Canavaggio, M., Welsh, L.
E., Johanson, J., & Quinn, T. C. (1996). Urine as a diagnostic specimen for
the detection of Chlamydia trachamatis in Malaysia by ligase chain reaction.
Sexually Transmitted Diseases, 23, 402-406.
Groer, M. W., & Shekleton, M. E. (1989). Basic pathophysiology: A
holistic approach. St. Louis: The C. V. Mosby company.
Hill, C. S. (1996, November). Gen-Probe transcription-mediated
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LL. D., Surgeon, Trans.). Huntington, NY: Robert E. Krieger Publishing
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Janier, M., Lassau, F., Casin, I., Grillot, P., Scieux, C., Zavaro, A.,
Chastang, C., Bianchi, A., & Morel, P. (1995). Male urethritis with and
without discharge: A clinical microbiological study. Sexually Transmitted
Diseases, 22, 244-252.
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Keeling, A. W. (1996). Care versus cure-examining the dichotomy
through a historical lens. Journal of Professional Nursing, 12, 131.
Laboratory Corporation of America (1997-1998). Director/ of services
& interpretive guide. Burlington, NC: Author.
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Lee, & C. L. Estes (Eds.), The nation's health (3rd ed., pp. 124-133).
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doctor in his community, an epidemiologic approach (3rd ed.). Huntington,
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ed.). Washington, DC: American Society for Microbiology.
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text. Philadelphia: W. B. Saunders Company.
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11). New York: Funk & Wagnells Publishing.
Rietmeijer, C. A. M., Judson, F. N., Boele Van Hensbroek, M., Ehret,
J. M., & Douglas, J. M. (1991). Unsuspected Chlamydia trachamatis infection
in heterosexual men attending a sexually transmitted disease clinic:
Evaluation of risk factors and screening methods. Sexually Transmitted
Diseases, 18, 28-35.
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Schachter, J., Stamm, W. E„ Chernesky, M. A., Hook, E. W., Jones,
R. B„ Judson, F. N., Kellogg, J. A., LeBar, B„ Per-Anders, M., McCormack,
W. M., Quinn, T. C., Ridgway, G. L, & Taylor-Robinson, D. (1992).
Nonculture tests for genital tract chlamydial infection. Sexually Transmitted
Diseases, 20, 243-244.
Schwebke, J. R., Sadler, R., Sutton, J. M., & Hook, E. W. (1997).
Positive screening tests for gonorrhea and chlamydial infection fail to lead
consistently to treatment of patients attending a sexually transmitted disease
clinic. Sexually Transmitted Diseases, 24,181-184.
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496-510. (Publication No. PHS-91-50212.)
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69
Appendixes
Appendix A
70
OOOO1
APPLICATION FOR ACCESS
TO PROTECTED DATA
ERIE COUNTY DEPARTMENT OF HEALTH
606 WEST SECOND STREET
ERIE, PA 16507
(814) 451-6700
January, 1998
71
app^tiT^ USER’S GU'DEF°R ACCESS TO PROTECTED DATA before completing this
I.
ORGANIZATION ORT INDIVIDUAL REQUESTING ACCESS
A.
Project Directon
B.
Title:
C.
Organization:
D.
Street Address
or P.O. Box:
E.
City, State, Zip Code:
F.
Telephone:
(Area code)
G.
H.
n.
Other persons who should be contracted if more information is needed:
1.
Name:
2.
Telephone:
3.
Address (if different than above):
1.
Name:
2.
Telephone:
3.
Address (if different than above):
Name and address of sponsor(s) or funding organization(s) for this project:
TITLE OF STUDY OR PROJECT
72
in.
OTHER ORGANIZATIONS PARTICIPATING IN THIS STUDY OR PROJECT
List the names of organizations and/or individuals who will obtain identifiable information or individ
ual case record data from Erie County Department of Health files and describe their roles in this study
Include consultants, outside nosologists, contractors, data processing vendors, subcontractors, and
sponsoring or participat
ing agencies or organizations. A “Supplemental Assurances Form” (see pages 12-15) must be com
pleted by EACH organization (or individual) listed below and must be signed by responsible officials of
that organization. The completed forms must be submined as an attachment(s) to this application form.
IV.
INSTITUTIONAL REVIEW BOARD FOR THE PROTECTION OF HUMAN SUBJECTS
Has this research project been reviewed and approved by an Institutional Review Board (IRB) for the
Protection of Human Subjects? (An IRB approval is required if this study or project involved any
“followback” activities to families, next-of-kin, or the study subject based on information provided by
Erie County Department of Health records.)
YES:
NO:
V.
Give the name of the review board and date of approval below and attach
a copy of the approval to this application.
Indicate reason.
SUMMARY OF STUDY PROTOCOL OR PROJECT ACTTVITIES
You may append a copy of your complete study protocol (or selected sections) to this application; how
ever, the abstract that you provide in response to these questions should be self-contained so that it
can serve as a complete and accurate description of the project though separate from any appended
document. Include the following information (A-F) in the description of your research plan or project
activities.
It is understood that some requestors might only be indirectly involved in research or statistical
activities (e.g., preparing and maintaining data files to be used in the research efforts of other organiza
tions) or for government agency projects. If any of these situations apply, you should first describe
your own activities and then indicate how the identifiable data released to you will be provided to and
used by other organizations.
IN RESPONDING TO THE FOLLOWING QUESTIONS, BE AS CLEAR AND AS SUCCINCT
AS POSSIBLE USING THE SPACE AVAILABLE. If you require additional space for answers,
insert a separate page(s) and number each answer.
73
A.
Describe the health or medical problem addressed by your study or activities.
B.
List the primary objectives, and include a description of the hypotheses to be
tested.
C.
Summarize the project’s data collection methods, indicating specific followback procedures,
if they •'■oply.
D.
Summarize the project’s analysis, indicating how the data will be used.
Describe any data files that will be linked with the data provided and specify the source of
these data files.
F.
In what form and to whom will the results of your study or activities be released?
74
VI.
EMPLOYEE REGISTRY DESCRIPTION
This section (pages 5-6) should be completed only if you are planning to include Erie County
Department of Health records
in an Employee Registry.
The following information is required to provide the Department of Health with assurances that Erie
County Department of Health records included in an Employee Registry will be used solely for
statistical purposes in medical or health research.
A.
What is the date that the Registry was founded?
B.
What is the purpose of the Registry?
C.
What is the eligibility criteria for including persons in the Registry?
D.
Will ±e records be flagged to identify them as Erie County Department of Health records?
YES
E.
Will the records be stored separately from the administrative records?
YES
F.
NO
NO
Is your organization OSHA regulated?
YES
NO
If yes, can you guarantee that Erie County Department of Health death records will not be released to
OSHA?
YES
NO
75
G.
List below each study which used records from the Employee Registry. All current studies
should be included as well as anticipated studies.
A summary protocol for each study listed above must be attached to this application form.
The summary should include the following information.
1.
Title of Study.
2.
Description of the health or medical problem addressed by your study.
3.
List of the primary study objectives and a description of the hypotheses to be tested.
4.
Summary of the project’s data collection methods, indicating specific followback
procedures, if they apply. Refer to the User’s Guide for the guidelines which must be
followed when using Erie County Department of Health records for followback
activities.
5.
Summary of the project’s analysis and how the data will be used.
6.
Description of any data files that will be linked with the data provided and the
sources of these data files.
7.
The form in which the results of the study will be released. Copies of any reports that
are published externally should be forwarded to the Erie County Department of
Health.
If the complete protocol is sent in lieu of this summary, the sections from the protocol which
contain the above requested information should be highlighted.
If Erie County Department of Health records are released for inclusion in your Employee
Registry, summary protocols of any future studies (which are not included in this
application) must be forwarded to the Erie County Department of Health for written
approval prior to using any Erie County Department of Health records in the study.
Amy changes to study protocols, particularly with respect to followback and additional uses
of the data, must be submitted to the Erie County Department of Health.
76
VIH. RECORDS AND/OR IDENTIFIABLE DATA REQUIRED
A.
In the matrix below, indicate the type and form of records, identifiable data, and/or individual
case record data requested. Provide an “X” in EACH box that is applicable:
Review
of
Records
Copies
of
Records
Facsimiles/
Computer
Listings
Computer
Data
Tapes
Diskettes
Death
Records
Birth
Records
Fetal Death
Records
Cancer
Records
Other
(Specify)
B.
Complete this section only if you are requesting review of records or copies ofrecords.
1.
How many names do you expect to submit to the Department?
2.
Is year of birth, death and/or date of diagnosis known for each name?
YES
NO
If yes, please specify range of years involved:
3.
How many future searches do you expect to request?
4.
Name the organization(s), including your own, which will be requesting review of records
or copies of records (itemize your responses if more than one organization will be involved).
77
C.
vm.
Complete this section only if you are requesting cancer facsimiles, computer listings, or
computer data tapes.
1.
Please list below the specific data items that you expect to obtain from each data file
and/or those items that are specifically needed for your study.
2.
How many future requests for this data do you expect to make?
MAINTAINING THE CONFIDENTIALITY AND SECURITY OF IDENTIFIABLE DATA
A.
How will you maintain the confidentiality and security of identifiable data obtained from
Department of Health records? (Identifiable data refers to any information which could
permit the identification of any individual. This is not only name and address, but also
individual case record data where other demographic items such as age, sex, race, and place of
residence could possibly be used to identify subjects.)
B.
Disposition of identifiable data:
1.
How long will you store copies of records or other identifiable data?
2.
How will you dispose of copies of records or other identifiable data?
3.
If there are no plans to dispose of some or all of the identifiable data, please explain
why.
78
C.
Approximate date of study completion:
D.
Will you require followback investigations based on information provided by Erie County
Department of Health records to obtain additional information from decedent’s next-of-kin,
study subjects, physicians, hospitals, and/or other individuals or facilitates mentioned in the
records?
YES
NO
If YES, briefly describe the following:
1.
Types of followback respondents to be contacted. (If the answer to this question
includes families, next-of-kin, or the study subject, please answer the following
questions 2 and 3.)
2.
Information to be obtained from respondents. (A copy of the survey form or ques
tionnaire must also be attached and labelled appropriately).
3.
Methods to be used in conducting such investigations. (A copy of consent form
and initial contact letter to be mailed to followback individual must also be
attached and labelled appropriately.)
19
E.
Will any of the identifiable data obtained from the records and/or followback investigations
be used as a basis for legal, administrative, or other actions which may directly affect
particular individuals as a result of their specific identification in this project?
YES
NO
If YES, Please explain.
F.
Will the identifiable data obtained from the records or followback investigations be used
either directly or indirectly for any project or purpose other than the one described in Pan
V?
YES
NO
If YES, briefly describe the other research project(s) or purpose(s) for which the data will be
used. A separate application form must be submitted for each project which will be using
protected data obtained from Erie County Department of Health records.
80
IX.
applicant assurances
The undersigned hereby agrees to the following terms and conditions related to this application and
to the use of information obtained from the Erie County Department of Health.
A.
The identifiable data obtained following written approval from the Department of Health
shall be used only for the study proposed and the purposes described in the “Summary of
Study Protocol or Project Activities” (Part V) and in the “Employee Registry Description”
(Part VI). Use of the information for a project or purpose other than that described in Parts
V and VI shall not be undertaken unless a separate application form for the subsequent
project has been submitted to, and approved by, the Erie County Department of Health.
B.
No individually identifiable data shall be released without prior written approval by the Erie
County Department of Health.
c.
If data extracted from Erie County Department of Health records are used in any
publication, the following statement must be included in such publication or any other
release of the data:
These data were supplied by the Erie County Department of Health, Erie County
Department of Health, Harrisburg, Erie County Department of Health. The Erie
County Department of Health specifically disclaims responsibility for any analyses,
interpretations or conclusions.
A copy of any published materials or study results should be made available to the Erie
County Department of Health upon request.
D.
I have thoroughly reviewed the contents of the User's Guide for Access to Protected Data
dated October, 1996, which are incorporated herein by reference, and I shall adhere to the
guidelines set forth therein.
E.
All statements entered in this application are true, complete, and correct to the best of my
knowledge and belief.
Project Director’s Name
Project Director’s Title
Organization
Signature
Date
81
ATTACHMENT A
ERIE COUNTY DEPARTMENT OF HEALTH
APPLICATION FOR ACCESS TO PROTECTED DATA
SUPPLEMENTAL ASSURANCES FORM
A separate Supplemental Assurances Form (pages 12-15) must be completed and signed by EACH organization listed
on page 3 of the application form as participating in this study. The Supplemental Assurances Form(s) must then be
submitted as an attachment to the application form. Additional copies of pages 12-15 may be made as required.
Name:
Title:
Organization:
Street Address or P.O. Box:
City, State, Zip Code:
Telephone:
(area code)
A.
How will you maintain the confidentiality and security of identifiable data obtained from the
Department of Health records? (Identifiable data refers to any information which could permit the
identification of any individual. This is not only name and address, but also individual case record
data where other demographic items such as age, sex, race, and place of residence could possible be
used to identify subjects.)
B.
Disposition of identifiable data:
1.
How long will you store copies of records or other identifiable data?
2.
How sill you dispose of copies of records or other identifiable data?
3.
If there are no plans to dispose of some or all of the identifiable data, please explain why.
82
C.
Approximate date of study completion:
D.
Will you require followback investigations to obtain additional information from decedent’s next-of-kin,
study subjects, physicians, hospitals, and/or other individuals or facilities mentioned on the records?
YES
NO
If YES, briefly describe the following:
1.
Types of followback respondents to be contacted. (If the answer to this question includes
families, next-of-kin, or the study subject, please answer the following questions 2 and 3.)
2.
Information to be obtained from respondents. (A copy of the survey form or questionnaire
must also be attached and labelled appropriately.)
3.
Methods to be used in conducting such investigations. (A copy of consent form and initial
contact letter to be mailed to followback individual must also be attached and labelled
appropriately.)
83
E.
Will any of the identifiable data obtained from the records and/or followback investigations
be used as a basis for legal, administrative, or other actions which may directly affect
particular individuals as a result of their specific identification in this project?
YES
NO
If YES, please explain.
F.
Will the identifiable data obtained from the records or followback investigations be used
either directly or indirectly for any project or purpose other than ;the one described in Part
V of the Application for Access to protected Data?
YES
NO
If YES, briefly describe the other research project(s) or purpose(s) for which the data will be
used. A separate application form must be submitted for each project which will be using
protected data obtained from Erie County Department of Health records.
84
APPLICANT ASSURANCES
The undersigned hereby agrees to the following terms and conditions related to this application and to the use of
information obtained from ±e Erie County Department of Health.
A.
The identifiable data obtained following written approval from the Department of Health shall be used only for the
study proposed and the purposed described in the "Summary of Study Protocol or Project Activities” and “Em
ployee Registry Description: (Parts V and VI of the Application for Access to Protected Data). Use of the infor
mation for a project or purpose other than that described in Parts V and VI shall not be undertaken unless a separat
application form for the subsequent project has been submitted to, and approved by, the Erie County Department or
Health Department
of Health.
B.
No individually identifiable data shall be released without prior written approval by the Erie County Department or
Health.
C.
If data extracted from Erie County Department of Health records are used in any publication, the following
statement must be included in such publication or any other release of the data:
These data were supplied by the Erie County Department of Health, Erie County Department of Health,
Harrisburg, Erie County Department of Health. The Erie County Department of Health specifically
disclaims responsibility for any analyses, interpretations or conclusions.
A copy of any published materials or study results should be made available to the Erie County Department of
Health upon request.
D.
I have thoroughly reviewed the contents of the User’s Guide for Access to Protected Data dated October, 1996,
which are incorporated herein by reference, and I shall adhere to the guidelines set forth therein.
E.
All the statements entered in this application are true, complete, and correct to the best of my knowledge
and belief.
Name
Title
Organization
Signature
applic-doc l/!3/98/»k
Date
85
COUNTY OF ERIE
Department of Health
JuChn M. Lyncn
Ccxjnty Executtve
606 West Second Street
Erie. Pennsytvcnia 16507
814/451-6700
Fax: 814/451-6767
Jo*eon IrzyoruJa
Ontcror
ERIE COUNTY BOARD Of HEALTH
SnxwyJ-Zogor>d
V*nc*nri_ Jonco. D.O.
^0*00 A Noowomy. M.O.
0. Zum
Bonrra K. Book*
Application Review Committee
The following committee members have reviewed and approved the contents of the
attached application. The committee reviewed the application for the proper and secure
use of identifiable data and assure proper disposal of data as stated in the proposal at the
end of the study . No identifiable data will be released. The principal investigator has
signed the applicant assurance statement of the application.
The Erie County Deparment of Health and Review Committee specifically disclaim
responsibility for any analyses, interpretations or conclusions. A copy of any published
material or study results will be made available to the Erie County Department of Heal±.
The review committee and principal investigator has reviewed the Users Guide for
Access to Protected Data which are incorporated herein by reference, and shall adhere to
the guidelines set forth therein.
Title of Study:.
Principal Investigator:.
Signature:
Reason for Study:.
Date of Review by Committee:.
.*
Approved by:
Signature
t
Date
/
Charlotte Berringer, Director
Personal Health Services
Erie County Department of Health
__ f
/.
Nancy K. Rea, Public Health Administrator
Administration
Erie County Department of Health
I
Joseph Trzybinski, Director
Administration
Erie County Department of Health
Signature
Date
Signature
__ /_
Date
Public Health is an Organized Community Effort Aimed at Preventing Disease,
Prolonging Ute, and Improving Emotional and Physical Efficiency.
Appendix B
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Appendix C
92
ERIE COUNTY DEPARTMENT OF HEALTH
STD CLINIC PATIENT CONSENT FORM
I
___________________ grant permission to the ERIE COUNTY DEPARTMENT
OF HEALTH to obtain specimens, perform treatments and share information about
myself, or my child
______ as may be necessary for proper medical care,
so long as I understand the procedures.
Date
Patient Signature
Witness
Date
Patient Signature
Witness
Date
Patient Signature
Witness
Date
Patient Signature
Witness
Date
Patient Signature
Witness
Date
Patient Signature
Witness
Date
Patient Signature
Witness
Date
Patient Signature
Witness
Date
Patient Signature
Witness
Date
Patient Signature
Witness
Date
Patient Signature
Witness
c:klsidcon.96
Z X ct
u;
Appendix D
93
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c.2
Kolpien-Bugaj, Karen.
White blood cells on
gram stain as a
1998.
White Blood Cells on Gram Stain as a
Treatment Indicator for Chlamydial Infection
by
Karen Kolpien-Bugaj, BA, BSN, RNC
Submitted in Partial Fulfillment of the Requirements
for the Master of Science in Nursing Degree
Approved by:
Jy^ith S. Schilling; CRNP, PhEjZ
Committee Chairperson
Edinboro University of Pennsylvania
bate
kip
7 4?
Jeanne M. Weber, EdD, CRNP
Committee Member
Edinboro University of Pennsylvania
Date
'ta
Nancy Rea, MHSA
Committee Member
Erie County Department of Health
______
Date
c- A
Abstract
Chlamydia infection in the United States has the highest incidence of
all infectious diseases tracked by the Centers for Disease Control and
Prevention. It is often without symptoms and there is no rapid, cost-effective
test method that provides both high sensitivity and specificity. Consequently,
the spread of the disease often occurs by patients who are unaware that they
are infected. Gram stain is one test which can be performed relatively quickly
and inexpensively. Although not able to directly detect chlamydia, it is
capable of detecting the presence of white blood cells (WBCs) indicative of
infection.
This study sought to examine what relationship may exist between
either the presence or absence of WBCs on Gram stain and chlamydia
infection. It also sought to identify other clinical factors with relationships to
chlamydia infection.
The clinic charts from 54 patients of a public health sexually
transmitted diseases clinic in northwestern Pennsylvania, were reviewed. A
matched groups design comparing the Gram stain WBC results of patients
who tested DNA chlamydia-positive and DNA chlamydia-negative was
performed. Other clinical factors were also compared between the two
groups.
ii
The Gram stain detected 93% (P=0.00014) of the chlamydia infections
present. In the group without chlamydia it erroneously predicted infection in
44% of the patients. No other factors were identified as more specific
indicators of chlamydial infection.
The author concluded that of the factors studied, the Gram stain was
the best clinical tool for prescribing presumptive treatment for chlamydia. The
data also support the literature by indicating that Gram stain is neither highly
sensitive nor specific for chlamydia, and further research and better tests are
needed for rapid effective detection of chlamydial infection.
iii
Table of Contents
Chapter
Page
Chapter 1. Introduction
1
Background of the Problem
2
Conceptual Framework
5
Statement of the Problem
16
Assumptions
17
Definition of Terms
18
Limitations
21
Summary
22
Chapter 2. Review of Literature
24
Goals and Guidelines for Screening and Treatment
24
Diagnostic Tests
26
Screening Characteristics
29
Treatment Characteristics
34
Treatment before test results
34
Treatment after test results
35
Nurse Practitioner Role
38
Summary
41
iv
Chapters. Methodology
44
Hypothesis
44
Operational Definitions
44
Research Design
46
Procedures
46
Sample
47
Informed Consent
49
Instrumentation
49
Demographics
49
Independent Variables
49
Dependent Variable
50
Data Analysis
51
Summary
51
52
Chapter 4. Results
Demographic Data
52
Clinical Indicators and DNA Probe Results
52
Gram Stain Versus Other Clinical Indicators
56
Gonorrhea Versus Chlamydia Results
57
59
Chapters. Discussion
59
Conclusions
v
Recommendations
61
References
64
Appendixes
69
A. Application for Access to Protected Data
70
B. User’s Guide to Access to Protected Data
86
C. Erie County Department of Health STD Clinic
92
Patient Consent Form
93
D. Data Collection Spreadsheet
vi
List of Tables
Table
Page
1. Chlamydia Infection in Heterosexual Men in a Study
Reported by Rietmeijer et. al. (1991)
31
2. Gram Stain Urethral Smear Results in 219 Men With
and Without Urethral Discharge from a Study Reported
by Janier et al
33
3. Patients With Positive Screening Tests Who Were
Not Treated at Initial Visit, and Time Intervals Until
Treatment Was Received, in a Study of 24,823 Patients
36
by Schwebke et. al
4. Criteria For Presumptive Treatment for chlamydia as
Reported by Nurse Practitioners in a Survey Performed
by Alexander et. al
40
5. Demographic Data for Study Sample Groups
53
6. DNA Probe Chlamydia Results and Results of Other
Clinical Indicators in Patients From the STD Clinic in this
54
Study
vii
List of Figures
Figure
Page
6
1. The Epidemiologic Triangle
2. The Dever Epidemiologic Model
10
3. The Epidemiologic Prevention Process Model
13
4. The Holistic Epidemiologic Prevention Process
15
Model for Advanced Practice Nursing
viii
1
Chapter One
Introduction
In this chapter, the history of sexually transmitted diseases (STDs) and
their impact on the health of individuals and communities will be examined
utilizing models of epidemiology as they are applied to public health and
advanced practice nursing. Specifically, the need for more consistent testing
and treatment guidelines for screening and treatment of patients with
Chlamydia trachamatis (chlamydia) will be reviewed. The use of Gram stain
and its clinical indications for the presence or absence of chlamydia are a
focus.
Historically, Hippocrates described syphilitic-type sores as early as 460
B.C. (Hippocrates, -460 B.C./1972). By 1953, penicillin was being heralded
as “the drug which would eradicate venereal disease” (Commonwealth of
Pennsylvania Department of Health [CPDH], 1970, p.17). The incidence of
syphilis fell from 106,539 cases in 1947, to a low of 6,516 in 1955. With
these dramatic results, funding that had supported a nationwide venereal
disease program was drastically decreased. The consequences were
evidenced by a rebound to more than 100,000 new cases of syphilis in 1962
(CPDH, 1970).
Richard D. Lamm, former governor of Colorado and director of
2
the Center for Public Policy and Contemporary Issues at the University of
Denver, has written “The Ten Commandments of Health Care” (Lamm,
1990). In it he cautions, “We must. . . establish norms and standards for
diagnostic and therapeutic practice that encompass both costs and medicine”
(p. 129). With chlamydia having pushed into the forefront as the leading
infectious disease in the United States (Eng & Butler, 1997), the domain of
public health has a challenge in effectively combating a 1990s compliment to
the syphilis of the past. Additionally, it comes at a time when limited
resources and increased competition within health care are mandating that
financial costs be examined more closely than ever before (U.S. Department
of Health & Human Services [HHS], 1994). For these reasons, it is
paramount that all primary health care providers judiciously strive to identify
patients at risk for chlamydia (Eng & Butler, 1997) in order to examine, test,
and appropriately treat them utilizing both valid and cost-effective means.
Background of the Problem
Tracked for the first time in 1995, chlamydia was the most common
infectious disease in the United States (Centers for Disease Control and
Prevention [CDC], 1996b). The 477,638 reported cases cited in the annual
report from the Centers for Disease Control and Prevention (CDC) showed
the incidence of chlamydia exceeded not just other sexually transmitted
3
diseases (STDs), but all other infectious diseases as well (CDC, 1996b). The
State of Pennsylvania counted 22,828 cases of chlamydia in 1995, with 825
of those being from Erie County (Erie County Department of Health, 1998).
In October 1997 the report of statistics for 1996 revealed that chlamydia
retained its position as the leading infectious disease (CDC, 1997d). In PA
and Erie County the 1996 cases numbered 18,445 and 624, respectfully (Erie
County Department of Health, 1998). Additionally, at the close of the 40th
week in 1997 when the 1996 report was released, the year-to-date national
case total for chlamydia in 1997, exceeded those for 1996 by 10,325 cases
(CDC, 1997e).
Screening for chlamydia has been deemed a priority by the CDC
because 75% of infected women and 50% of infected men are asymptomatic
(CDC, 1997c). In women, untreated chlamydia can progress to pelvic
inflammatory disease, infertility, or potential ectopic pregnancy. The cost of
treating these complications exceeds $2 billion annually (CDC, 1997c). The
CDC estimated that one-half of all chlamydia cases occurred in teens ages
15 to 19, and predicted that the impact to both lives and cost could be greatly
reduced by expanded screening for the disease. Although less likely to suffer
from untreated complications, men have rarely been included in routine
screenings. They can, however, develop sequelae such as epididymitis or
4
proctitis and their untreated chlamydial infections become a risk to female
sexual partners who, if pregnant, may pass that risk onto an unborn fetus
(CDC, 1996a). Because chlamydia is sexually transmitted, decreasing the
incidence of this disease and its complicating sequelae must include
screening and appropriate treatment for both men and women (CDC, 1996a).
Traditionally, consistent guidelines for screening have been lacking
due to the large number of screening tests available (Schachter et. al.,
1992). Additionally, once screened, patients are often unable to be located
or refuse to return for treatment. (Schwebke, Sadler, Sutton, & Hook, 1997).
This has created a need for tests that provide immediate results and, in the
absence of such tests, clear guidelines or indicators for presumptive
chlamydia treatment (Schachter et. al., 1992).
As of 1994, major medical authorities including the American Academy
of Pediatrics, the American Academy of Family Practice, the American
College of Obstetricians and Gynecologists, the American Medical
Association, the Centers for Disease Control and Prevention, and the United
States Preventive Services Task Force have advocated routine screening for
STDs (Eng & Butler, 1994). Criteria for identifying patients at risk and in
need of screening include all patients in STD, family planning, or
adolescent clinics, as well as anyone under the age of 20 who admits to
5
multiple sex partners. They added that prostitutes, patients with a past
history of STDs, or those who are untreated since sexual contact with an
infected partner, should also be screened.
Conceptual Framework
In developing the conceptual framework for this study, three existing
conceptual frameworks were reviewed. They were; a) The Epidemiologic
Triangle, b) The Dever Epidemiologic Model, and c) The Epidemiologic
Prevention Process Model. These models were then integrated to form The
Holistic Epidemiological Prevention Process Model for Advanced Practice
Nursing, used in this study.
Screening has been encouraged for the identification of infection and
for risk factors that, when appropriately acted upon, will prevent disease
(Mausner & Bahn, 1974). Historically, the theory of epidemiology originated
with Hippocrates in the 5th century B. C., in his writings titled “On Airs,
Waters, and Places” (Hippocrates, -460 B. C./1972). Utilizing this premise,
in 1958, Leavell and Clark (1979) developed an epidemiological concept that
depicts the natural history of disease in man. It states that disease begins via
a stimulus generated by interrelations between the agent, host, and
environment. These three factors are depicted in The Epidemiologic Triangle
(Figure 1) as the three points of the triangle. Epidemiology theory seeks to
6
ENVIRONMENT
AGENT
FIGURE 1
HOST
The Epidemiologic Triangle
(Adapted from Mausner, J. S., & Bahn, A. K.: Epidemiology An
Introductory Text. W. B. Saunders Company, Philadelphia, 1974, p. 33.)
7
identify, then remove or interrupt, interrelations between these factors as a
means of disease prevention and control (Mausner & Bahn, 1974). For
epidemiological purposes Mausner and Bahn defined these three factors.
The first, the host, is the organism whose health is being focused upon.
There are conditions which must be true of the host for disease to occur. In
this study the hosts were the STD patients, and sexual activity of the host
would be a condition necessary for the disease of chlamydia to occur.
The second factor is the agent and is something which may be present
or absent, but alone is not sufficient to cause disease without certain
conditions within the other two factors being met. Chlamydia is the agent that
was examined in this study. The third factor is the environment. This is the
surroundings of the host and contains conditions that impact the host. Often
these surroundings are separated into the three categories of biological,
social, and physical environments. STD patients had biologic environments
(ie: individual immune status), social environments (ie: peer pressure), and
physical environments (ie: accessibility to a location conducive for sexual
activity to occur) as potential catalysts for chlamydia infection.
As primary care providers, nurse practitioners need to be aware of
which patients (potential hosts) to screen for chlamydia. They must have
adequate knowledge of which testing methods will provide optimal accuracy
8
for the diagnosis and effective treatment of chlamydia (the agent).
Additionally, they must be aware of methods for prevention of reinfection,
spread of the disease, and complicating sequelae (environmental influences).
Leavell and Clark’s (1979) model defined the point at which
interrelations between the host, agent, and environment first generate a
stimulus for disease as a period of “Prepathogenesis.” During this phase
they cite two components of possible intervention termed “health promotion”
and “specific protection.” Preventive measures implemented within this
phase are called “primary prevention.” The second period of disease
according to Leavell and Clark (1979), is that of “Pathogenesis.” In this
phase the host produces a response to the stimulus from phase one. They
listed the following three components of possible prevention within this
period: a) early diagnosis and prompt treatment, b) disability limitation, and
c) rehabilitation. Measures of prevention implemented in the first two they
called “secondary prevention.” Any preventive measures instituted during the
rehabilitation phase they termed “tertiary prevention.
Primary prevention measures such as educational campaigns that
focus on sexuality, condom use, disease education, and esteem building, are
all utilized within the scope of public health. Secondary prevention is
9
accomplished through early diagnosis and effective treatment and has three
objectives that are: a) to prevent and cure disease processes, b) to prevent
the spread of communicable diseases and, c) to prevent complications and
sequelae of communicable diseases (Leavell and Clark, 1979).
These basic definitions of primary, secondary, and tertiary prevention
continue to be utilized within epidemiology today, but have been broadened
to accommodate science and medicine by taking diseases far beyond the
confines of the “germ theory” (Phillips, 1986). Expounding upon the three
factors of The Epidemiologic Triangle Alan Dever, health-policy analyst,
created The Dever Epidemiological Model (Figure 2) (Clark, 1992). Dever
identified four determinants of health status and listed three comprising
components within each. They are: a) human biology comprised of genetics,
physiological function and maturation, b) environment comprised of physical,
psychological and social elements, c) life-style comprised of employment,
consumption, and leisure, and d) health-care system comprised of
availability, accessability, and utilization.
Dever’s model was relevant to the STD patients in this study as
follows:
1
Biology. Each patient’s genetics were individual and although
patients were matched for age, gender, and race physiologic function and
10
human biology
Genetics
Physiologic Function
Maturation
ENVIRONMENT
Physical
Psychological
Social
LIFE-STYLE
Employment
Consumption
Leisure
HEALTH-CARE SYSTEM
Availability
Accessibility
Utilization
FIGURE 2
The Dever epidemiologic model
(From Clark, M. J.: Nursing In The Community. Appleton &
Lange, Norwalk, Connecticut, 1992, p. 114.)
11
maturation levels were unique to each patient. The numbers of white blood
cells seen on each patient’s Gram stain was the biologic indicator used in the
study.
2. Environment. The physical environment included the surroundings
where the patient lives. The psychological and social encompassed
dynamics of interpersonal relationships, values, and emotions that all
influenced the choices surrounding the patients’ sexual activities. Whether
the patient had contact to a sexual partner infected with chlamydia, and other
sexual history of the patient were environmental indicators for infection.
3. Life-style. Whether the patients were employed or in school, and
whether or not they used alcohol or recreational drugs is data that was
included on the patients’ charts but not recorded as part of this study.
Leisure time activities often are largely influenced by the above. The
combination of these factors influenced patient choices that were
determinants of patients’ health status (ie: decisions to be sexually active,
have multiple sex partners, condom use etc.) As an indicator of lifestyle,
patients in the study were matched as either “established" or “first visit”
clients.
4 Health-care system. Patients can only utilize health care that is
accessible and available to them. The clinic studied provided anonymity and
12
provided testing and treatment at no charge and offered various clinic
schedules as a means of heightening availability and client accessability.
T. S. Eliot wrote, “The whole earth is our hospital” (1943, p. 30). This
premise has traditionally separated community or public health from other
forms of health care. Specifically, in community nursing the principles of
epidemiology are utilized as a foundation for practice which is geared not just
to the individual but to the “whole earth,” the community. By combining the
levels of prevention identified by Leavell and Clark (1979) with Dever’s
Epidemiological Model, the Epidemiologic Prevention Process Model
(Figure 3), utilized in community health nursing, was developed (Clark, 1992).
In this model, the above four components make up “Step 111 or the “client
assessment” phase of the nursing process. In “Step 2" a “nursing diagnosis”
is derived from the assessment. Steps 3 through 5 utilize the three levels of
prevention; primary, secondary and tertiary. Using these, in “Step 3" a
nursing plan of intervention is decided upon. In “Step 4" the plan is
implemented and in “Step 5" an evaluation of the outcome completes the
nursing process.
By building upon the epidemiologic prevention process from nursing
and combining it with the holisitic approach characteristic of advanced
practice nursing, The Holistic Epidemiologic Prevention Process for
13
Nursing Process
Step 1
Client
assessment
Epidemiologic perspective
Human Biology
Environment
Life-style
Health System
Step 2
Nursing
diagnosis
Step 3
Planning
intervention
Step 4
Implementing
the plan
Levels of prevention
Primary prevention
Secondary prevention
Tertiary prevention
Step 5
Evaluating
FIGURE 3
The epidemiologic prevention
process model
(From Clark, M. J.: Nursing In The Community. Appleton &
Lange, Norwalk, Connecticut, 1992, p. 119.)
14
Advanced Practice Nursing Model (Figure 4) can be derived (Chinn &
Kramer, 1995). The components of this model are as follows:
Step 1. The performance of a holistic client history, assessment, and
examination.
Step 2. Determination of a clinical diagnosis based upon the
assessment data.
Step 3. Development of a plan of treatment and/or therapy.
Step 4. Execution of the plan via order, prescription, or referral. This
plan may combine the various levels of prevention and may include
medications, behavior modification, and lifestyle changes. It also may
incorporate ancillary or alternative health care providers as needed to provide
a holistic plan of care.
Step 5. Evaluation of the plan, and a holistic client reassessment.
The medical community has traditionally been one that is disease
focused, not patient focused (Keeling, 1996). Assessment for appropriate
treatment, patient education, and contact notification for communicable
diseases such as chlamydia were historically referred to public health nurses
and officials, who retrospectively applied principles of epidemiology to
medical diagnoses and treatments already rendered. Nurse practitioners are
educated to see patients holistically and provide care that incorporates
15
Advanced Practice
Nursing Process
Step 1
Holistic client
examination &
assessment
Epidemiologic perspective
Human Biology
Environment
Life-style
Health System
Step 2
Formulation
of a clinical
diagnosis
Step 3
Developing a
plan of care
& prevention
Step 4
Ordering &
prescribing
the plan
Levels of prevention
Primary prevention
Secondary prevention
Tertiary prevention
Step 5
Evaluation
& holistic
reassessment
FIGURE 4
The holistic epidemiologic
prevention process model
for advanced practice nursing
(Developed by Kolpien-Bugaj, K. 1998)
16
health promotion through disease prevention and patient education, as well
as to diagnose and treat the disease process (Keeling, 1996). The nurse
practitioner role incorporates elements of both medicine and traditional public
health which may make it one of the best suited to combat diseases such as
chlamydia. To effectively do so requires that the most reliable assessment
tools be utilized. If the number of WBCs on Gram stain is a valid predictor for
chlamydia diagnosis, NPs could be trained to do them. If it is not a reliable
indicator, are there other clinical characteristics that could be obtained using
a holistic examination and assessment which would more reliably predict
infection? Identifying such indicators could assist the screening and
treatment of individuals with chlamydia seen in clinical practice.
Statement of the Problem
Documented cases of chlamydia occur in the United States more
frequently than any other infectious disease (CDC, 1997c). An estimated 3.5
million cases go undetected and unreported each year with consequent lack
of screening, diagnosis, and treatment largely attributed to its asymptomatic
nature. There are no consistent guidelines for the detection of chlamydia.
The testing methods most often used do not provide results at the time of the
patient’s office visit. Once a positive result is received, patient compliance
17
with treatment follow-up is often difficult to obtain.
A method for detection of chlamydia, or clinical indicators with a high
positive predictive value for infection, could facilitate immediate treatment and
improve the prevention and control of further disease. Because a
concentration of WBCs is a biologic response to inflamation, and since an
infection such as chlamydia should evoke the inflammatory response, WBCs
should be present in biologic tissues infected with chlamydia. This study
sought to answer the following research question: What relationship is there
between the presence of white blood cells on female cervical and male
urethral Gram stains, and chlamydial infection?
Assumptions
This study was based upon the following assumptions:
1. Guidelines for the diagnosis and treatment of chlamydia,
nongonococcol urethritis, and mucopurulent cervicitis, as designated by the
CDC, were valid.
2. Generally accepted performance standards had been met and
maintained by all medical and laboratory personnel who performed testing,
diagnosis, and treatment of patients at risk for chlamydia and related sexually
transmitted diseases.
3 Patient records provided accurate information regarding medical
18
history, physical examination findings, appropriate laboratory test specimens,
patient contact information, test results, medical diagnosis, and treatments
prescribed.
4. Testing supplies were uncontaminated, unexpired, and capable of
accurately assessing for the presence or absence of infection.
5. The presence of white blood cells on Gram stain was indicative
of inflammation and/or infection due to some underlying agent of pathology,
and chlamydia as an agent stimulates the presence of WBCs.
6. Untreated chlamydia could result in complicating sequelae and an
increased risk of infection with the human immunodeficiency virus, (CDC,
1997c).
7. Treatment indicated that a patient received either medication, or a
prescription for medication, approved by CDC guidelines for treatment of
chlamydia.
Definition of Terms
The succeeding terms were defined for this study as follows:
1
Chlamydia trachomatis are nonmotile, obligate, intracellular
parasites that were once thought to be viruses. They now are known to more
closely resemble bacteria because they contain both Deoxyribonucleic acid
(DNA) and ribonucleic acid (RNA) genetic material, and have a cell wall
19
similar to the one seen in Gram-negative bacteria. They are transmitted
between human hosts via the contact and exchange of infected genital body
fluids. They are generally vulnerable to specific macrolide and tetracycline
antibiotic treatments.
2. Nongonococcal urethritis is an inflammation of the urethra with an
etiology other than Neisseria gonorrhoeae or Trichomonas vaginalis (CDC,
1997a).
3. Mucopurulent cervicitis is an inflammation of the cervix with an
etiology other than Neisseria gonorrhoeae or Trichomonas vaginalis (CDC,
1997a).
4. Gram stain is a laboratory test used to look for evidence of the
presence of microorganisms by examination of the number and type of blood
and tissue cells observed, and/or the evidence of various bacteria, following a
specified staining process (Laboratory Corporation of America [Lab Corp],
1997-1998). When observed under a microscope, Gram-positive organisms
will appear blue, and Gram-negative organisms will appear red (Lennette et.
al., 1980). The test is useful for identifying the presence of Neisseria
gonorrhoeae in genital specimens due to the distinct Gram-positive diplococci
bacteria evident in gonorrhea infection. Gram stain is also a screening tool
for the presence or absence of other infections, as determined
20
by the number of polymorphonuclear (PMN) white blood cells viewed per
microscopic field (Lab Corp, 1997-1998). Because Chlamydia trachamatis is
an intracellular organism it cannot be detected on Gram stain. Therefore, the
absence of Gram-positive diplococci, and the presence of PMN-WBCs
indicate an infectious process from an agent other than Neisseria
gonorrhoeae. Because chlamydia has the highest incidence of all STDs,
WBCs on Gram stain, in the absence of Gram-positive diplococci, may be
due to chlamydial infection.
5. Transcription Mediated Amplification (TMA) is a laboratory test
utilizing a Hybridization Protection Assay method. It uses specimen DNA
probes that are acidinium ester-labeled, and specific to the target organism’s
amplified sequence. The organism is released by either chemical or
mechanical means. The TMA targets ribosomal RNA (rRNA) with the
breakdown of a single bacterial cell resulting in up to 10,000 copies of rRNA
being made. This gives the test an assay sensitivity of less than one cell (Hill,
1996).
6. White Blood Cells (WBCs) are immune cells that can kill many
pyogenic bacteria and fungi. They are a defense mechanism of the human
body, mobilized by the inflammatory response to the infection of the host by a
foreign (or biologically perceived foreign) agent (Groer & Shekleton, 1989).
21
7. A specimen is a sample from a potential host of cells, tissues, or
fluids known to act as a reservoir for an agent of disease (Fischbach, 1988).
8. A wet mount is a cervical mucous specimen added to 5-7 drops of
normal saline on a glass slide. It is covered with a coverslip and viewed
under a microscope for the presence of yeast buds or hyphae, Trichomonas
vaginalis organisms, or large WBCs known as “clue cells” present in bacterial
vaginosis (Carr, Freund, & Somani, 1995)
9. Presumptive treatment is any patient who received a CDC
approved treatment regime for chlamydia prior to the availability of results
from a laboratory test specific for chlamydia.
Limitations
This examination of the research question was limited by the following
factors:
1. The data collected had an optimum accuracy equivalent to that
which is reasonably attainable with those tests being utilized because all
available methods of testing for chlamydia can give false-negative results
(Eng & Butler, 1994).
2. Only data from one clinic site was utilized which decreases the
generalization of the results obtained to other populations and types of
medical sites.
22
3. Laboratory results were derived from male urethral or female
cervical specimens and were obtained by multiple practitioners who, while
following clinical guidelines, may still have some variability in clinical
technique.
4. Race, gender, age, and visit status as a new patient or established
patient, were all controlled for to limit bias from any of these confounding
variables.
Summary
Chlamydia is currently being reported with a greater incidence than
any other infectious disease (CDC, 1997c). It is often asymptomatic and, left
untreated, can lead to costly, complicating sequelae (CDC, 1997c). Certain
groups have been targeted by leading medical organizations for screening of
chlamydia, in an attempt to decrease its spread by utilizing principles of
epidemiology. Tests used for screening often give false-negative results, and
no consistent guidelines for screening and presumptive treatment have been
firmly established (Schachter, et. al., 1992). Knowledge of which patients to
screen, and accurate diagnosis and appropriate treatment for chlamydia, fall
within the scope of practice of nurse practitioners. With the knowledge that
white blood cells are mobilized by the immune system to the site of invasion
by foreign agents, it can be concluded that they would be
23
directed to the mucous membranes of the genital tracts of human hosts
infected by the agent of chlamydia. Patients who exhibit symptoms related to
the inflammatory response of infection, such as pain or evidence of infectious
exudate in the form of cervical or urethral discharge, would be assumed to
have white blood cells present as a part of this bodily response. But, what
about patients who have no complaint of symptoms and no clinical signs of
inflammation upon exam? Are signs and symptoms absent due to a lack of
an inflammatory response or, in a Gram stain of a specimen from the site,
would evidence of infection and inflammatory response be detectable by the
presence of white blood cells? If so, then a Gram stain with white blood cells
in the absence of any Gram-positive diplococci indicative for gonorrheal
infection, could be a valid predictor of chlamydial infection. If a lack of signs
and symptoms coincides with a lack of white blood cells on Gram stain in
patients with confirmed chlamydia infection, then it may be a poor diagnostic
indicator.
24
Chapter 2
Review of Literature
In this review of literature, studies focusing on patient screening
strategies, diagnostic laboratory tests utilized for screening, and approaches
to treatment for chlamydia have been examined. Changes in laboratory
technology and requirements, and their effect on the screening process, are
discussed. The role of the nurse practitioner in effectively screening, testing,
and treating patients for chlamydia is also reviewed.
Goals and Guidelines for Screening and Treatment.
Ideally, decreasing the incidence of sexually transmitted diseases
requires that many variables be competently addressed (Eng & Butler, 1997).
These include assessment of risk; laboratory testing and screening; physical
examination; appropriate diagnosis and treatment; partner notification and
follow-up; and patient education and counseling regarding the disease, its
method of transmission, consequences of nontreatment, and behavioral
change for future risk reduction. The degree to which these goals are met is
often directed by the availability of resources. Traditionally, assessments of
the quality of public health measures to address these variables have been
limited (Eng & Butler, 1997). In a recent report, the Institute of Medicine
found that, upon conducting on-;■site visits and in personal work with public
25
health STD clinics, that there was little emphasis placed
on quality indicators
for screening and treatment of chlamydia. Emphasis was on the number of
patients screened, not upon the number that tested positive and who were
adequately or appropriately treated (Eng & Butler, 1997). This finding
correlated with the CDC’s (1993a) recommendations for chlamydial program
evaluation. The CDC suggested that information should be gathered to
provide quantitative estimates about diseases, and follow trends. This should
include any interventions that are performed, and an evaluation of their
impact. They further recommended that such data be analyzed from an
epidemiologic perspective and be used as the basis for decisions regarding
future allocation of resources and evaluation of chlamydia prevention
programs.
In Healthy People 2000, Health Status Objective 19.2 states, “Reduce
Chlamydia trachamatis infections, as measured by a decrease in the
incidence of nongonococcal urethritis, to no more than 170 cases per
100,000 people (Baseline: 215 per 100,000 in 1988)” (HHS, 1991, pp. 498).
In it’s most recent treatment guidelines for sexually transmitted diseases, the
CDC defined nongonococcal urethritis (NGU) in men as urethral inflammation
not caused by Neisseria gonorrhoeae. The diagnosis of urethral
inflammation is based upon the presence of urethral discharge, the presence
26
of white blood cells (WBCs) on a Gram stain smear, or a positive urine
leukocyte esterase test (for any man under 60, who has no history of
urogenital diseases). A diagnosis of NGU also requires that no laboratory
evidence of N. gonorrhoeae be detected (CDC, 1997a).
Women may also get urethritis from various agents, including
chlamydia, but they are more often tested and evaluated via endocervical
specimen. The CDC defines mucopurulent cervicitis (MPC) in women as
cervical inflammation that is not the result of Neisseria gonorrhoeae or
Trichomonas vaginalis. Any mucopurulent secretion noted from the
endocervix that is yellow or green when viewed on a white cotton swab
(positive swab test) is considered diagnostically positive. In addition, any
induced endocervical bleeding that results when the swab is first introduced
into the endocervical canal is also criteria for diagnosis of MPC. Laboratory
tests must also show no evidence of either Neisseria gonorrhoeae or
Trichomonas vaginalis (CDC, 1997a).
Diagnostic Tests
In 1995, a group of researchers from the CDC performed a national
survey of STD testing sites across the United States. The purpose was to
evaluate laboratory testing being used for sexually transmitted diseases.
What Consuelo M. Beck-Sague (1996) and her colleagues discovered was
27
that, when asked what test, or tests, had been added within the past 2 years,
nonculture tests for chlamydia were most often sited by survey respondents
(34 of 81 [42%]). When asked to specify why that particular test had been
recently included at their site, the most frequent response was that of
available funding specifically targeted for chlamydia testing (25 of 81
[30.9%]), (Beck-Sague, et. al.).
Of the sites using the nonculture chlamydia tests, 51.4% reported that
they were using either enzyme immunoassays (ElAs), (55 of 254 [21.6%]),
deoxyribonucleic acid probes (nucleic acid probes or DNA probes), (51
[20.1%]), direct flourescent antibody (DFA), (20 [7.9%]), or polymerase chain
reaction (PCR), (2 [<1%]) tests (Beck-Segue, et. al., 1996). The remaining
126 of 254 (49.6%) of respondents failed to designate which nonculture test
was utilized at their site.
In the same study, when asked to list any test, or tests, that their site
had ceased using within the past 2 years, the tests most often listed were the
Gram stain or culture for gonorrhea (Beck-Sague, et. al., 1996). The number
of facilities that performed stat Gram stains decreased from 170 in 1992 to
111 by the time of this study's 1994 survey (Beck-Sague, et. al.). When
asked the reason for dropping that particular test, 91.9% of respondents cited
their inability to comply with the more
stringent requirements implemented by
28
the Clinical Laboratory Improvement Act as the reason for the discontinuation
(Beck-Sague et. al.).
Another test for chlamydia, which was not mentioned at all in the study
by Beck-Segue et. al., (1996), is the ligase chain reaction (LOR) urine test. A
study performed at Johns Hopkins University (Gaydos et. al., 1995),
compared the sensitivity and specificity of the LCR to the EIA for chlamydia.
Their results showed the LCR to be both highly sensitive (100% for males
and 100% for females tested) and specific (99.6% for men and 98.5% for
women) in its detection of chlamydia. By comparison, the EIA was found to
be far less sensitive (10% for men and 15.2% for women); its specificity was
also less, but not as dramatically ( 99.6% for men and 98.9% in women),
(Gaydos et. al.). The LCR is still a relatively new test. It is a more expensive
test than the other methods currently available and, therefore, not yet as
widely used (Gaydos et. al.). To perform this test, urine specimens need to
be centrifuged, then supernatant aspirated by pipet and a urine buffer added.
This mixture is then heated to 100°C, cooled, frozen and shipped to a
research laboratory. There, a probe amplification of the chlamydial DNA is
performed by target-dependent ligation of complementary oligonucleotide
probes by DNA ligase, after they have annealed to the gene target sequence.
The specimens are then thermocycled after being added to hapten-
29
conjugated probes, buffer, and ligase, the thermostable enzyme. Once
thermocycling is completed, amplified chlamydial DNA is detected by using
an automated EIA test.
Part of the problem in effectively combating chlamydia is the fact that
there is no test for chlamydia which has been established as the “gold
standard” (Schachter et. al., 1992). Newer nonculture tests for chlamydia
have been developed with sensitivities and specificities exceeding those of
the chlamydia culture. Schachter and colleagues concluded that due to the
variety of tests that are available, and the characteristics of chlamydia, there
is a need for a comprehensive control program that sets criteria for diagnosis
and treatment of both symptomatic and asymptomatic individuals.
Screening Characteristics
Although high risk women are often screened through routine health
care sought for birth control or illness, women with chlamydia are more likely
to be asymptomatic (75%) than are men (50%) (CDC, 1997c). Conversely,
CDC research found that although men may more often be symptomatic,
they often have fewer screening opportunities. In one study of untreated,
symptomatic heterosexual men, 45% spontaneously became asymptomatic
within 1 month of testing (Rietmeijer, Judson, Boele Van Hensbroek, Ehret, &
Douglas, 1991). This lead the researchers to conclude that, while there has
30
been less attention to screening and follow-up of men in the past, it may be
worth increasing emphasis on men, as an indirect means of lowering the
incidence of chlamydia infection in women.
In a total of over 4500 clinic visits, Rietmeijer et. al. (1991) found that
42% of the men met the traditional treatment criteria for chlamydia. Twenty
seven percent were diagnosed with NGU based upon the presence of
> 4 PMN/HPF on Gram stain. There were 11% who were treated because of
their diagnosis of gonorrhea and almost 4% who had had sexual contact with
a female partner who had been diagnosed with, or was suspected of having,
chlamydia. Men who remained asymptomatic comprised almost 41% of the
total. The final 17% presented with complaints consistent with urethritis, but
were not diagnosed or treated because they had not met any of the above
criteria (Reitmeijer et. al., 1991). The results revealed that using the 1989
screening and testing recommendations of the CDC had failed to detect and
promote treatment in 23.4% of the infected population. Table 1 contains the
data from this Reitmeijer et. al. study.
In an attempt to increase the sensitivity of the Gram stain as a
screening tool, Rietmeijer et. al. (1991) used successively decreasing
numbers of PMNs, down to a low of > 1 PMN/HPF, as the criteria for
diagnosis of NGU. Even at that lowest level, they found that 45% of
31
Table 1
Chlamydial Infection in Heterosexual Men in a Study Reported by Rietmeijer et. al.
(1991).
Diagnostic Category
Infected with Gonorrhea
Total Tested
Total Positive
n
(%)
n
(%)
516
(11-0)
62
(8-1)
1266 (27.0)
494
(64.9)
179
(3.8)
27
(3-5)
803
(17.1)
52
(6.8)
Infected with NGU by > 4
PMN/HPF on Gram Stain
Contact to Infected Partner
Symptomatic but without
Objective Evidence
Asymptomatic
1917 (40.9)
126
(16.6)
Total
4681
761
(100.0)
(100.0)
Note. NGU=Nongonococcal Urethritis, PMN=Polymorphonucleocyte, HPF=High Power
Field.
32
infections still would have been missed by the Gram stain. Based upon this
finding, these researchers concluded that the best method for detecting
chlamydial infection and the need for treatment at the time of the initial clinic
visit is not clear. They further indicated that additional research is needed to
determine the most effective, expedient, and economic approach towards
maximizing treatment at initial patient visits (Rietmeijer et. al., 1991).
Another group of researchers did a comparison of overall STD testing
results for men with and without presenting symptoms (Janier et. al., 1995).
They utilized Gram stain, but with >5 PMN/HPF as the cut-off criteria for
diagnosis of NGU (Table 2).
In their conclusions, Janier et. al. (1995) emphasized the low
sensitivity that a Gram stain smear had for indicating chlamydial infection in
patients who reported no symptoms. They also pointed out that even in
patients with symptoms, the sensitivity of the Gram stain was still only 86%.
They concluded that every patient who presents with urethral symptoms
should have a PGR for chlamydia performed, regardless of whether
discharge is noted or PMNs are present on Gram stain. They noted that
when discharge was present, Gram stain remained a valuable tool for the
exclusion of N. gonorrhoeae.
33
Table 2
Gram Stain Urethral Smear Results in 219 Men With and Without Urethral Discharge from
a Study Reported by Janier et. al. (1995).
With Discharge (n=122)
Pathogen Category
Without Discharge (n=97)
Smear +
Smear -
Smear+
Smear -
n
(%)
n
(%)
n
(%)
n
(%)
Chlamydia
18
(19)
3
(11)
2
(7)
5
(7)
Gonorrhea
23
(24)
2
(8)
0
(0)
0
(0)
Ureaplasma
9
(9)
3
(11)
1
(4)
2
(3)
Mycoplasma
25
(26)
4
(15)
4
(15)
4
(6)
Trichomonas
3
(3)
0
(0)
0
(0)
Indeterminate results
7
7
23
0
(0)
23
Patients with > 1
67
(70)
12
(46)
7
(26)
11
(16)
Pathogens
9
(9)
6
(23)
7
(26)
23
(33)
No Pathogen
20
(21)
8
(31)
13
(48)
36
(51)
Total Patients
96
Pathogen
Patients with Only
Indeterminate
26
27
70
34
Treatment Characteristics.
Once a patient has completed the screening and testing processes,
the question of treatment arises. In a recent study, clinical records covering
an 18 month period from over 35,000 patients of a county health department
STD clinic were reexamined (Schwebke et. al., 1997). This study was one of
the first to question how many patients with positive test results were actually
treated.
Treatment Before Test Results. The study by Schwebke et. al. (1997)
revealed that only 1% of men who had positive cultures for gonorrhea had not
been treated at their initial clinic visit, while the rate of untreated chlamydia at
initial visit was 11%. For women, the rates were 12% and 44%, respectively.
Of all the patients who reported no symptoms at their initial clinic visit, and left
without receiving any kind of treatment, 12% had tests that showed they were
infected with N. gonorrhoeae and 44% had tests showing they were infected
with chlamydia. This rate was only 1% below the 45% failure rate of Gram
stain screening that was found by Rietmeijer et. al. (1991).
In the same study, Schwebke et. al. (1997) also discovered that
screening detection rates for women were higher than for men. Patients’
charts from an STD clinic were reviewed for a designated 18 month interval.
35
The numbers of patients who tested positive for gonorrhea and chlamydia
were compared to those who received presumptive treatment for these
infections. They found that chlamydia went untreated at a much higher rate
than did gonorrhea, and that women were more likely to go untreated than
were men (Table 3).
Treatment After Test Results. Once notified of infection, 20% of
patients in the Schwebke et. al. (1997) study had not returned for treatment
30 days later. An additional 30% who returned to be treated did not do so
until 2 or more weeks after their initial visit (Table 3). From an epidemiologic
perspective, this 2 or more weeks of untreated time was viewed as a
facilitator of disease spread due to the characteristics of the sexual practices
among high risk populations. It allowed others to become infected by those
who never returned for treatment, or during the 2-week interval between the
visits of those who did return.
With the discovery that high screening numbers did not assure
treatment of patients who tested positive, Schwebke et. al. (1997) suggested
that future emphasis needs to be placed on evaluating and identifying the
best indicators for initial visit treatment. They further concluded that failing to
treat patients deemed infected nullifies the value of the screening process.
Based upon the constructs of epidemiology, Schwebke et. al. (1997)
36
Table 3
Patients With Positive Screening Tests Who Were Not Treated at Initial Visit, and Time
Intervals Until Treatment Was Received, in a Study of 24,823 patients by Schwebke et.
al. (1997).
Patients
No Treatment
Treatment
Within 30 Days
Treatment
In < 13 Days
In 14-30 Days
n / total
(%)
n / total
(%)
n / total
(%)
GC
95 / 530
(18)
286 / 530
(54)
149/530
(28)
CT
125/634
(20)
286 / 634
(45)
223 / 634
(35)
GC
20/34
(59)
8/34
(23)
6/34
(18)
CT
11/43
(26)
20/43
(46)
12/43
(28)
GC
115/564
(20)
294 / 564
(52)
155/564
(28)
CT
136/677
(20)
306 / 677
(45)
235 / 677
(35)
Females
Males
Totals
Note. GC=gonorrhea, CT=chlamydia.
37
concluded that one method of increased treatment compliance among
infected individuals may be through direct observation therapy, fashioned
after the tuberculosis model for treatment, and by utilizing single-dose
therapy. They further determined that the data from their study had important
implications for future efforts to control and prevent sexually transmitted
diseases.
In the studies previously sited, Rietmeijer et. al. (1991) studied only
Gram stain as it applied to men; Schwebke, et. al. (1997) found that
screening cultures for both gonorrhea and chlamydia detected infection in
women far more often than in men. Neither of these studies looked at Gram
stain as a screening tool for women. This researcher found no data on
women for comparison to the data Rietmeijer et. al. collected for men. If
other indicators of chlamydial infection that occur simultaneously with positive
Gram stain in women can be identified, they could facilitate future criteria for
chlamydia treatment in the private health sector.
Beck-Segue et. al. (1996) found that most primary care settings did not
have the capability to maintain the requirements necessary for a laboratory
certified to perform Gram stains. They also identified the fact that, while
screening numbers and positive tests in private sector offices may be far
fewer than in large public clinics, their role or value in the total picture of
38
combating STDs is still important.
Nurse Practitioner Role
As nurse practitioners (NPs) become more common in primary care
offices, they will increasingly be in settings where on-site laboratory facilities
may be less accessible than in the past. A national survey sought to examine
NPs’ knowledge levels and treatment practices concerning chlamydia in their
female patients (Alexander, Treiman, & Clarke, 1996). Of over 1600
questionnaires mailed, a response rate of 38% was obtained resulting in over
600 respondents.
Of those, 49% identified their work site as a family
planning or public health clinic. Overall, 88% of respondents had a scope of
practice which included family planning, STDs, or gynecology. This study
revealed that chlamydia was the most common STD identified in the tests of
their patients. Fifty-five percent felt “very knowledgeable” and 40%
“knowledgeable” about STDs, while 60% to 80% answered questions
regarding chlamydia accurately. The only NP knowledge deficits identified
by the study were related to appropriate screening and treatment of pregnant
patients with chlamydia (Alexander et. al., 1996).
When questioned about the type of diagnostic testing their facility
utilized, 72% of the NPs reported that tests were performed at an off-site
laboratory (Alexander et. al., 1996). The types of tests varied, with enzyme
39
immunoassay (EI A), direct flourescent antibody (DFA), nucleic acid
hybridization (DNA), and culture all being named. Only 3% reported use of a
rapid diagnostic test, which takes less than 30 minutes for on-site results.
This study echoed previous ones by Schachter et. al. (1992) and Janier et. al.
(1995) by declaring that “no single test has yet emerged as simple,
noninvasive, inexpensive, specific and sensitive” (p. 51).
The most frequently cited reason for delayed or absent treatment, was
the lag time between the screening tests and the availability of the results
(Alexander, et. al., 1996). The rates of presumptive treatment reported in the
survey were compared to the current CDC guidelines (Table 4).
Of all the survey treatment scenarios, patients were most likely to be
presumptively treated for chlamydia (by 93% of the NPs) when they reported
a sex partner infected with chlamydia (Alexander et. al., 1996). Conversely,
they were least likely to be presumptively treated for chlamydia (by only 39%
of the NPs) if they reported that a sex partner had acute urethral syndrome.
Of all of the patients who did receive presumptive treatment reported in the
survey, 24% of the nonpregnant and 34% of pregnant patients received either
inappropriate or inadequate treatment according to the CDC guidelines.
These data, obtained from NPs working predominantly (88%) in family
planning, STD, and gynecology settings, reinforce the need for more
40
Table 4
Criteria For Presumptive Treatment for Chlamydia as Reported by Nurse
Practitioners in a Survey Performed by Alexander et. al, (1996).
Treatment Circumstance
NPs (n=611)
Patient says partner has CT*
93%
Patient has signs and systems of PID*
88%
Patient has MPC**
84%
Patient says partner has NGU
72%
Patient says partner has GC*
68%
Patient has signs / symptoms of GC*
66%
Wet prep shows high WBC count
61%
Patient says partner has epididymitis
40%
Patient has acute urethral syndrome**
39%
Never presumptively treat
0%
Notes. ‘Conditions which indicate presumptive treatment based upon CDC
recommendations. **Conditions which may indicate presumptive treatment
depending upon other risk factors, based upon CDC recommendations.
CT=Chlamydia, GC=Gonorrhea, PID=Pelvic Inflammatory Disease, MPC=Mucopurulent
Cervicitis, NGU=Nongonococcal Urethritis, NP=Nurse
Practitioner, WBC=White Blood Cell.
41
specific guidelines and criteria regarding which patients to screen, what tests
to use, and whom to treat.
Is this study reflective of all NPs, or would the knowledge level and
treatment deficits of NPs who work in family practice differ at all from those
whose practice is primarily with women, reproduction, and public health? If
NPs must play a role in the fight against chlamydia and its sequelae, what
screening criteria, and testing data will best equip them? What role, if any,
could use of Gram stain play in screening and presumptive treatment for
chlamydia? Alexander et. al. (1996) concluded that nurse practitioners do
need continuing education to perform adequate management of all sexually
transmitted diseases within their patient populations.
Summary
The literature supports the application of the Epidemiologic Model with
regard to chlamydial infection and barriers to its successful control. The
“host” factors of variances between men and women, pregnant versus
nonpregnant, symptomatic versus asymptomatic, have been examined.
Characteristics of the “agent” that promote the of spread of chlamydia, while
simultaneously making development of a single reliable test difficult, have
also been reviewed. The “environment” has been viewed by factors such as
a social climate of risk and noncompliance, a biologic risk from other STD
42
co-infections which may be present, or as physical risks where results of tests
simply are not available on-site or in a timely manner. All of these
epidemiologic factors have been reviewed in an attempt to learn what can be
done differently, in a better attempt to control chlamydial infection. Gram
stain has been identified as one component within the matrix of chlamydia
control.
In this review of literature, studies that identified the lack of current,
consistent guidelines for screening and treatment of chlamydia, were
examined. Various diagnostic testing methods, and comparisons of their
effectiveness, have been mentioned. Screening methods and criteria for
presumptive treatment, as well as lack of treatment and difficulty of patient
compliance, have also been reviewed. The role of the nurse practitioner in
the screening, testing, and treatment of chlamydia was discussed because
their increasing numbers as primary care providers necessitate adequate
knowledge for management and control of all sexually transmitted diseases,
including chlamydia.
Because of the holistic approach that nurse practitioners bring to
primary care, they are well equipped to focus on the epidemiology of
chlamydia control and may be able to serve as a bridge between the medical
and public health communities. This could result in a positive impact on
43
chlamydia control efforts.
44
Chapter 3
Methodology
If presumptive gonorrheal infection can be ruled out using a Gram
stain, but white blood cells (WBCs) are still present, perhaps their presence is
due to chlamydial infection. If their presence is a reliable positive predictor of
patients infected with chlamydia, even in the absence of signs or symptoms,
utilizing Gram stain would be a relatively simple, inexpensive, and immediate
test for infection. These are all attributes of a desirable screening or
diagnostic test for chlamydia. However, since the Gram stain may identify
WBCs associated with conditions other than chlamydia, it is not a specific
test. This chapter presents the hypothesis, operational definitions, research
design, procedures, sample, informed consent, instrumentation, and data
analysis that were utilized to execute this study.
Hypothesis
Patients with chlamydia infection will have white blood cells on Gram
stain with or without clinical signs or symptoms. White blood cells on Gram
stain, in patients with or without clinical signs or symptoms, will not empirically
indicate chlamydia infection.
Operational Definitions
The following terms were operationally defined for this study.
45
1. White blood cells (WBCs) refer to polymorphonuclear (PMN) white
blood cells, as identified by Gram stain laboratory testing.
2. Nongonococcal urethritis (NGU), a diagnosis for any male patient,
is defined by a Gram stain smear without Gram positive diplococci indicative
of gonorrhea that exhibits > 5 WBCs per oil immersion field (oim) (CDC,
1993b).
3. Mucopurulent cervicitis (MPC), a diagnosis for any female patient,
is defined by a Gram stain smear without Gram positive diplococci indicative
of gonorrhea that exhibits >10 WBC/oim (CDC, 1993b).
4. Chlamydial infection or chlamydia refers to genital Chlamydia
trachamatis infection of adults and adolescents who have sought testing and
treatment, and who were tested using transcription mediated amplification
(TMA) obtained via male urethral or female cervical DNA probes.
5. Gram stain refers to either a male urethral or female cervical slide
smear prepared as follows: After the slide is fixed by heating with a flame, it
is flooded with a crystal violet solution which is left on for 1 minute. It is
washed briefly with tap water, and drained. It is then flooded with iodine
which is allowed to stand for 1 minute. It is then washed with tap water
again. Next it is decolorized with a mixture of 95% ethyl alcohol and 5%
acetone, until it runs clear. The slide is then counterstained with safranine
46
for 10 seconds, washed with tap water, and blotted dry (C. Cancilla, personal
communication, November 12, 1997).
Research Design
This study was conducted utilizing a quantitative, matched groups
design. It was implemented through a retrospective examination of clinical
patients’ charts from the Erie County, PA Health Department’s sexually
transmitted diseases (STD) clinic.
Procedures
Charts of patients seen in clinics conducted over a 6 month time
period from July 1, 1997 through December 31, 1997, were reviewed. These
months were chosen to coincide with the health department’s contracts for
the chlamydia test method, and laboratory analysis of the tests, both of which
began on July 1, 1997.
Only those charts indicating that a nurse assigned to the STD division
saw the patient and obtained the specimens fortesting, were considered.
Any records indicating that nurses from another division obtained the clinical
data were excluded due to what could be a lower level of experience and
proficiency.
The data to be examined were from patients who presented during
sessions consistently staffed by one physician who had extensive experience
M
with STD patients. Additionally, the same laboratory technician was also
present and had experience performing Gram stains.
Sample
The sample of 54 patients was derived from the population of patients
who sought testing and treatment for STDs over a six month period in 1997,
at the Erie County, PA Health Department. A second case control sample
matched by race, gender, age, and clinic status as either a new patient or
established patient, was chosen from the same population and same six
month time period. Patients were included regardless of race, sex, religion,
ethnicity, age, income, or health insurance status. Permission for use of the
sample population data was obtained utilizing a written Access to Protected
Data contract between the researcher and the Erie County Department of
Public Health (Appendix A). It was completed according to the standards set
by the Division of Health Statistics, Pennsylvania Department of Health,
User’s Guide for Access to Protected Data (Appendix B). All patients signed
a dated written consent for testing and treatment (Appendix C).
The patients were referred to by an assigned clinic number whenever
addressed outside of a clinic room. They were assured of confidentiality and
were not required to produce any type of identification. No billing was
conducted, so no insurance cards or social security information was
48
obtained. Although a patient’s address and phone number were recorded, if
patients requested no calls or mail, they were not contacted unless there was
an emergency.
Prior to leaving the clinic, patients were issued a code number to use if
they called the clinic in regards to their visit or to obtain any test results. If
they called without the number, no information was given until they appeared
in person and produced identification. This prevented parents, sex partners,
spouses, friends, or any other medical establishment from accessing
information without written consent. Medical information from charts was
never sent over a FAX, unless a clear threat to the patient’s life or well-being
had been established and the patient’s permission to release information
had been received.
From the population of patients as described, seen within the
designated time period for this study, two matched sample groups were
chosen for inclusion. The first group was comprised of any patient who
tested positive for chlamydia. The second was comprised of patients who
tested negative for chlamydia. The groups were matched for age, gender,
race, and whether they were first time attenders to the STD clinic, or had
been seen on previous visits in the past.
49
Informed Consent
Due to the security, anonymity, and confidentiality regarding all patient
clinical records, any follow-up contact with patients regarding the information
reviewed for this study was prohibited by the policies and procedures of the
health department’s medical division. Because individuals whose chart
information was utilized were never identified, informed consents from the
patients whose records were reviewed, were not required fortheir inclusion in
the study. The Access to Protected Data included consent to utilize the
records in a confidential manner on-site, with the agreement that no
identifying information be recorded or utilized in the study.
Instrumentation
In accordance with the study design a spreadsheet was used to record
the data from each patient’s chart (Appendix D). The following data were
collected:
1. Demographic Characteristics . The age, gender, race, and the
patient’s status as a “first visit” or “established patient” were recorded.
2. Independent Variables. Several independent variables were
recorded and included:
a. Was there a patient complaint of urethral or vaginal discharge?
b. Were any signs of urethral or cervical discharge recorded by the
50
nurse who performed the patient’s examination and testing?
c. Was urethral or cervical bleeding recorded by the nurse when the
test specimen was obtained?
d. The results of the Gram stain to include: 1) Gram-positive
diplococci, indicating gonorrheal infection, 2) WBCs sufficient to meet criteria
for diagnosis of NGU or MPC, 3) the presence of both Gram-positive
diplococci and WBCs sufficient to meet the criteria for diagnosis of NGU or
MPC and gonorrhea.
e. Wet mount results (female patients only), for detection of: 1) yeast,
2) Trichomonas, 3) clue cells indicative of bacterial vaginosis.
f. Any medications prescribed for the presumptive treatment of
chlamydia on the date of the clinic visit.
g. Whether the patient returned for chlamydia treatment at a later date.
h. The nurse who performed the examination and testing.
3. Dependent Variable
Results of any laboratory tests sent to an off-site lab for Transcription
Mediated Amplification (TMA) chlamydia and gonorrhea testing:
a. TMA/DNA probe gonorrhea result.
b. TMA/DNA probe chlamydia result.
51
Data Analysis
The data from each patient’s chart were tabulated utilizing the
Statistical Package for Social Scientists (SPSS) for Windows Base System
User’s Guide Release 6.0 version. They were statistically analyzed using
frequency tables, and T-tests for continuous variables. Pearson uncorrected
chi square analysis and Fisher’s two-tailed test were used for categorical
variables. Differences between groups were considered statistically
significant if P< 0.05. These statistical analyses were then reviewed as a
basis for either accepting or rejecting the hypothesis of the study.
Summary
This chapter has outlined the methods of the study. The hypothesis
was defined and the operational definitions, the research design, and
procedures to be used in the testing of the hypothesis were detailed. The
sample was discussed, as was the instrumentation used for data collection,
and the statistical analysis of the data.
52
Chapter 4
Results
In this chapter, the statistical analysis of the data collected from 54
patient charts are discussed. It includes comparisons of clinical indicators
and Gram stain results to DNA probe results. Additionally, a comparison of
gonorrhea and chlamydia results are reviewed.
Demographic Data
There were 22 (40.7%) white and 32 (59.3%) black patients included
in the study. Thirty-six (66.7%) were male and 18 (33.3%) were female.
Patients who had been to the clinic on at least one other occasion numbered
12 (22.2%), while those who were there for the first time were 42 (77.8%).
The mean age of the clients was 19.6 years, with a range from 16 to 30 years
of age. However, 36 (66.6%) of the 54 patients included in the study were
aged 16 to 19 years (Table 5).
Clinical Indicators and DNA Probe Chlamydia Results
The results of the Gram stains for WBCs and the DNA probes for
chlamydia did show a statistically significant relationship (P=0.00014). These
results and those of the other clinical indicators examined, and their
corresponding DNA test results are shown in Table 6. Thirty-seven (69%) of
the 54 patients were diagnosed with either nonspecific cervicitis (NSC) or
53
Table 5
Demographic Data for Study Sample Groups
Patients
Chlamydia Positive
Chlamydia Negative
n=27
n=27
18
18
9
9
White
11
11
Black
16
16
Age 16-19
18
18
Age 20 - 30
8
8
Age > 30
1
1
21
21
6
6
Males
Females
First patient visit
Established patient
54
Table 6
DNA Probe Chlamydia Results and Results of Other Clinical Indicators in Patients From the STD Clinic in
This Study.
DNA Probe Chlamydia +
DNA Probe Chlamydia -
P (chi-squared
n=27 No.(%)
n=27 No.(%)
Patients
Yes
No
Yes
No
Totals
27
0
27
0
25(93) 2(7)
12(44)
15(55)
P=0.00014
Patient Reports Discharge
10(37)
17(63)
10(37) 17(63)
P=1.0 NS
Gram+ Diplococci on GS
5(19)
22(81)
5(19)
22(81)
P=1.0 NS
14(52)
13(48)
P=0.09087 NS
6(22)
21(78)
P=0.75026 NS
test)**
WBCs on GS
Diagnosed as NSC/NGU
Nurse Reported Discharge
Observed on Exam
20(74) 7(26)
20(74)
DNA+ for Gonorrhea
7(26)
First Visit to the Clinic
20(74) 7(26)
22(81) 5(19)
P=0.51269 NS
Note. DNA Deoxyribonucleic acid, GS=Gram stain, NSC=Nonspecific cervicitis, NGU=Nongonococcal
urethritis, WBCs=White blood cells. **P=The probability as computed by using the Pearson chi square two-
tailed level of significance value < 0.05.
55
nongonococcal urethritis (NGU) based upon their Gram stain results. All of
them were presumptively treated for chlamydia except for one, whose results
were inadvertently misinterpreted by the physician. One patient was not
diagnosed with NSC or NGU but was treated presumptively for chlamydia
based upon sexual contact to a partner infected with chlamydia.
Ten
patients (19%) had Gram-positive diplococci present on the Gram stain and
were presumptively diagnosed with gonorrhea as a result. All ten of these
also had white blood cells (WBCs) sufficient on Gram stain to be diagnosed
with either NSC or NGU. They were treated for chlamydia based upon either
of those criteria as, designated by the Centers for Disease Control and
Prevention treatment guidelines (CDC, 1993b).
When the laboratory results of the DNA probes were received they
revealed that 13 patients (24%) had been treated presumptively for
chlamydia who tested negative for chlamydia by DNA probe. Conversely,
only two patients (<1%) without sufficient WBCs on Gram stain had positive
chlamydia results. Of the ten patients diagnosed with gonorrhea based upon
the Gram stain, five (9%) had DNA probe results positive for gonorrhea, while
the remaining five had negative results.
Two patients who had no Gram-positive diplococci, but did have
WBCs on Gram stain, had DNA probe results positive for both gonorrhea and
56
chlamydia. Two patients had WBCs and Trichomonas when initially seen but
were also DNA-positive for chlamydia. One patient had yeast, Gram-positive
diplococci, and WBCs all present when first seen with a DNA probe positive
for both chlamydia and gonorrhea.
Gram Stain Versus Other Clinical Indicators
Comparing other data to Gram stain as indicators for chlamydia
infection revealed that 20 (37%) of the 54 patients complained of either a
vaginal or urethral discharge. Of these, ten (19%) were chlamydia-positive
and the other ten were chlamydia-negative (P=1.0), from study totals of 27
chlamydia-positive and 27 chlamydia-negative patients. When clinical data
recorded by the nurses who performed the physical examinations and testing
were compared, they reported that discharge was observed from 19 (35%) of
the patients who also exhibited WBCs on gram stain and were subsequently
DNA-positive for chlamydia. One patient who had discharge recorded, as
observed by the nurse who performed the exam, did not exhibit WBCs on the
Gram stain, but had DNA results positive for chlamydia. The nurses were
able to identify 20 of 27 (74%) of the patients infected with chlamydia in
comparison to the Gram stain identifying 25 of 27 ([93%] P=0.09).
Where the WBCs on Gram stain indicated presumptive treatment of
chlamydia in 12 of 27 (44%) patients who tested DNA probe negative, the
57
nurses observed urethral or cervical discharge in 14 of 27 (52%) patients who
tested DNA probe chlamydia negative. In patients not observed to have any
discharge the nurses missed 7 of 27 (26%) patients who tested
DNA-positive, while the absence of WBCs on Gram stain missed just 2 of 27
(7%) positive patients.
Gonorrhea Versus Chlamydia Results
Overall, there were 8 patients the nurses reported as having no
discharge who had WBCs on the Gram stain. Six of these were DNApositive for chlamydia and 2 were DNA-positive for gonorrhea. Both of the
patients reported by the nurses as having no discharge, who later were
confirmed to have gonorrhea by the DNA probe, had also both lacked
Gram-positive diplococci on the Gram stain. In contrast to the two patients
who were chlamydia-positive but exhibited no WBCs on the Gram stain, all
ten of the patients who tested positive for gonorrhea also were positive for
WBCs on the Gram stain, even in the two cases where the Gram-positive
diplococci were absent.
None of the other clinical indicators were statistically significant in this
study besides the relationship between Gram stain WBCs and DNA probe
chlamydia results. Due to possible interrelations between the other clinical
factors there may be other relationships present that, if isolated, would be
58
clinically and statistically significant to chlamydia infection.
59
Chapter 5
Discussion
The relationship between the presence of white blood cells (WBCs) on
Gram stain and chlamydia infection was studied in 54 patients who attended
a public health clinic for sexually transmitted diseases (STDs). Other clinical
indicators were also examined for their relationship to chlamydia. Although a
relationship between the Gram stain and DNA chlamydia results was found,
the presence of multiple other infections within both the sample groups made
other relationships difficult to isolate. This chapter will review conclusions
that were drawn and recommendations for future studies that may provide a
clearer look at other clinical indicators for chlamydia.
Conclusions
A Gram stain with an absence of WBCs had a higher predictive value
of a DNA chlamydia-negative test than did a Gram stain with the presence of
WBCs of a DNA chlamydia-positive test. This supports the research
hypothesis being studied. The Centers for Disease Control and Prevention
give criteria for presumptive treatment for chlamydia (CDC 1993b). The data
of this study support the literature with the conclusion that there is no clear
indicator concerning which patients may be infected with chlamydia, and
60
which ones are not. Two patients infected with chlamydia left the clinic
without medicine to treat it, based upon their Gram stain results. Conversely,
there were twelve patients given medication for chlamydia based on their
Gram stains, who didn’t need it because they were actually chlamydia-
negative.
When compared to the other indicators for infection that were
collected, no others were more accurate than the WBCs on Gram stain in
predicting which patients might be infected. Urethral or cervical discharge
observed by the examining nurse was the closest, but 14 patients (26%) with
observed discharge tested DNA-negative for chlamydia, and seven patients
(13%) without observed discharge tested DNA-positive for chlamydia.
Therefore, the nurses’ observations were not consistent as positive predictors
of chlamydial infection. However, of the 54 patient charts reviewed, there
were only three patients with discharge observed by the nurse who did not
test positive for some type of genital infection and, if studied further may hold
statistical significance. One of these three had already tested positive for
chlamydia at another facility, and one had a sexual partner infected with
gonorrhea.
Since all ten patients who were DNA-positive for gonorrhea had
WBCs on Gram stain (including the two who lacked any Gram-positive
61
diplococci), in this study the WBCs had a higher positive predictive value for
gonorrheal infection than did the presence of Gram-positive diplococci, even
though preliminary diagnosis of gonorrhea was based upon the diplococci,
not the WBCs being present. Since one-half of those patients with gonorrhea
also had chlamydia, it isn’t clear which infection was more or less directly
associated with the WBCs present.
In the study by Janier et. al. (1995), urethral smears had a sensitivity
of 86% for detection of chlamydia in patients with discharge. Comparatively,
the data collected in this study had a sensitivity of 68%. The research by
Janier et. al. and others that studied the indications of WBCs on Gram stain,
have only looked at men. This study included both men and women. It is not
clear what differences this may have made in the overall results obtained, but
since women with yeast, Trichomonas, and gonorrhea were all identified and
any of the three can cause discharge, part of the answer may lie here.
Recommendations
Due to the small sample size, generalizations cannot be readily made
from the data which were obtained. Some interesting questions for future
research, however, are raised. Although this study sought to examine testing
for chlamydia, one of the most interesting findings was that all patients who
tested DNA-positive for gonorrhea had WBCs present on the Gram stain,
62
while two were lacking the Gram-positive diplococci traditionally used as the
Gram stain criteria for preliminary gonorrhea diagnosis. A study comparing
the WBCs and Gram-positive diplococci for gonorrhea infection is a possible
indication for future research. Additionally, while the nurses’ reports of
discharge in patients was not as reliable as the Gram stain in predicting
chlamydial infection, it was clearly more predictable than the report of
discharge by the patients. Due to the multiple possible pathogens with which
patients may be infected, it is likely that some patients the nurses reported as
having discharge may well have had pathogens other than chlamydia as the
source. A future study which used a sample population of patients found to
be infected with chlamydia only may be a more specific method of assessing
the value of both WBCs on Gram stain, and nurses reports of discharge, as
chlamydial indicators. Due to the physiological differences between men and
women, and the effects these differences may play in the biological
manifestations of infection, studying the relationship of WBCs and discharge
to chlamydial infection may be better carried out in studies that examine just
men or just women.
This study does show that in the interests of public health, and the
control of the spread of chlamydia, the presence of WBCs on the Gram stain,
and the presence of either urethral or cervical discharge, are both strong
63
enough indicators of infection to treat the patient presumptively. In a private
practice where Gram stain is likely to be unavailable, signs of discharge
indicative of infection warrant treatment. If wet mount for females is available
and is free from Trichomonas, yeast, and clue cells, the presence of WBCs
may be an indicator of either a chlamydial or gonorrhea infection. Research
to correlate WBCs from Gram stain to wet mount could be valuable in
assessing the wet mount as a tool for detection of these two infections.
With medications such as azithromycin now available for single-dose
therapy for both gonorrhea and chlamydia, and with the health maintenance
organizations (HMOs) putting pressure on primary care providers to reduce
costs, treating patients who have observable discharge or who exhibit signs
of infection using a wet mount, may well be more efficacious than the cost of
DNA tests. Using a 2 gram dose of azithromycin would effectively treat both
gonorrhea and chlamydia in a single dose not only eliminating the cost of the
DNA testing, but also the wait which often results in treatment failure, or the
opportunity for disease spread in the interim.
64
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Diseases, 20, 243-244.
Schwebke, J. R., Sadler, R., Sutton, J. M., & Hook, E. W. (1997).
Positive screening tests for gonorrhea and chlamydial infection fail to lead
consistently to treatment of patients attending a sexually transmitted disease
clinic. Sexually Transmitted Diseases, 24,181-184.
U. S. Department of Health and Human Services, Public Health
Services (1991). Healthy people 2000: National health promotion and
disease prevention objectives. Washington, DC: Public Health Service, 1991:
496-510. (Publication No. PHS-91-50212.)
U. S Department of Health and Human Services Staff, Office of
Disease Prevention and Health Promotion (1994). Clinician's handbook of
preventive services: Put Prevention Into Practice, McLean, VA: International
Medical Publishing.
69
Appendixes
Appendix A
70
OOOO1
APPLICATION FOR ACCESS
TO PROTECTED DATA
ERIE COUNTY DEPARTMENT OF HEALTH
606 WEST SECOND STREET
ERIE, PA 16507
(814) 451-6700
January, 1998
71
app^tiT^ USER’S GU'DEF°R ACCESS TO PROTECTED DATA before completing this
I.
ORGANIZATION ORT INDIVIDUAL REQUESTING ACCESS
A.
Project Directon
B.
Title:
C.
Organization:
D.
Street Address
or P.O. Box:
E.
City, State, Zip Code:
F.
Telephone:
(Area code)
G.
H.
n.
Other persons who should be contracted if more information is needed:
1.
Name:
2.
Telephone:
3.
Address (if different than above):
1.
Name:
2.
Telephone:
3.
Address (if different than above):
Name and address of sponsor(s) or funding organization(s) for this project:
TITLE OF STUDY OR PROJECT
72
in.
OTHER ORGANIZATIONS PARTICIPATING IN THIS STUDY OR PROJECT
List the names of organizations and/or individuals who will obtain identifiable information or individ
ual case record data from Erie County Department of Health files and describe their roles in this study
Include consultants, outside nosologists, contractors, data processing vendors, subcontractors, and
sponsoring or participat
ing agencies or organizations. A “Supplemental Assurances Form” (see pages 12-15) must be com
pleted by EACH organization (or individual) listed below and must be signed by responsible officials of
that organization. The completed forms must be submined as an attachment(s) to this application form.
IV.
INSTITUTIONAL REVIEW BOARD FOR THE PROTECTION OF HUMAN SUBJECTS
Has this research project been reviewed and approved by an Institutional Review Board (IRB) for the
Protection of Human Subjects? (An IRB approval is required if this study or project involved any
“followback” activities to families, next-of-kin, or the study subject based on information provided by
Erie County Department of Health records.)
YES:
NO:
V.
Give the name of the review board and date of approval below and attach
a copy of the approval to this application.
Indicate reason.
SUMMARY OF STUDY PROTOCOL OR PROJECT ACTTVITIES
You may append a copy of your complete study protocol (or selected sections) to this application; how
ever, the abstract that you provide in response to these questions should be self-contained so that it
can serve as a complete and accurate description of the project though separate from any appended
document. Include the following information (A-F) in the description of your research plan or project
activities.
It is understood that some requestors might only be indirectly involved in research or statistical
activities (e.g., preparing and maintaining data files to be used in the research efforts of other organiza
tions) or for government agency projects. If any of these situations apply, you should first describe
your own activities and then indicate how the identifiable data released to you will be provided to and
used by other organizations.
IN RESPONDING TO THE FOLLOWING QUESTIONS, BE AS CLEAR AND AS SUCCINCT
AS POSSIBLE USING THE SPACE AVAILABLE. If you require additional space for answers,
insert a separate page(s) and number each answer.
73
A.
Describe the health or medical problem addressed by your study or activities.
B.
List the primary objectives, and include a description of the hypotheses to be
tested.
C.
Summarize the project’s data collection methods, indicating specific followback procedures,
if they •'■oply.
D.
Summarize the project’s analysis, indicating how the data will be used.
Describe any data files that will be linked with the data provided and specify the source of
these data files.
F.
In what form and to whom will the results of your study or activities be released?
74
VI.
EMPLOYEE REGISTRY DESCRIPTION
This section (pages 5-6) should be completed only if you are planning to include Erie County
Department of Health records
in an Employee Registry.
The following information is required to provide the Department of Health with assurances that Erie
County Department of Health records included in an Employee Registry will be used solely for
statistical purposes in medical or health research.
A.
What is the date that the Registry was founded?
B.
What is the purpose of the Registry?
C.
What is the eligibility criteria for including persons in the Registry?
D.
Will ±e records be flagged to identify them as Erie County Department of Health records?
YES
E.
Will the records be stored separately from the administrative records?
YES
F.
NO
NO
Is your organization OSHA regulated?
YES
NO
If yes, can you guarantee that Erie County Department of Health death records will not be released to
OSHA?
YES
NO
75
G.
List below each study which used records from the Employee Registry. All current studies
should be included as well as anticipated studies.
A summary protocol for each study listed above must be attached to this application form.
The summary should include the following information.
1.
Title of Study.
2.
Description of the health or medical problem addressed by your study.
3.
List of the primary study objectives and a description of the hypotheses to be tested.
4.
Summary of the project’s data collection methods, indicating specific followback
procedures, if they apply. Refer to the User’s Guide for the guidelines which must be
followed when using Erie County Department of Health records for followback
activities.
5.
Summary of the project’s analysis and how the data will be used.
6.
Description of any data files that will be linked with the data provided and the
sources of these data files.
7.
The form in which the results of the study will be released. Copies of any reports that
are published externally should be forwarded to the Erie County Department of
Health.
If the complete protocol is sent in lieu of this summary, the sections from the protocol which
contain the above requested information should be highlighted.
If Erie County Department of Health records are released for inclusion in your Employee
Registry, summary protocols of any future studies (which are not included in this
application) must be forwarded to the Erie County Department of Health for written
approval prior to using any Erie County Department of Health records in the study.
Amy changes to study protocols, particularly with respect to followback and additional uses
of the data, must be submitted to the Erie County Department of Health.
76
VIH. RECORDS AND/OR IDENTIFIABLE DATA REQUIRED
A.
In the matrix below, indicate the type and form of records, identifiable data, and/or individual
case record data requested. Provide an “X” in EACH box that is applicable:
Review
of
Records
Copies
of
Records
Facsimiles/
Computer
Listings
Computer
Data
Tapes
Diskettes
Death
Records
Birth
Records
Fetal Death
Records
Cancer
Records
Other
(Specify)
B.
Complete this section only if you are requesting review of records or copies ofrecords.
1.
How many names do you expect to submit to the Department?
2.
Is year of birth, death and/or date of diagnosis known for each name?
YES
NO
If yes, please specify range of years involved:
3.
How many future searches do you expect to request?
4.
Name the organization(s), including your own, which will be requesting review of records
or copies of records (itemize your responses if more than one organization will be involved).
77
C.
vm.
Complete this section only if you are requesting cancer facsimiles, computer listings, or
computer data tapes.
1.
Please list below the specific data items that you expect to obtain from each data file
and/or those items that are specifically needed for your study.
2.
How many future requests for this data do you expect to make?
MAINTAINING THE CONFIDENTIALITY AND SECURITY OF IDENTIFIABLE DATA
A.
How will you maintain the confidentiality and security of identifiable data obtained from
Department of Health records? (Identifiable data refers to any information which could
permit the identification of any individual. This is not only name and address, but also
individual case record data where other demographic items such as age, sex, race, and place of
residence could possibly be used to identify subjects.)
B.
Disposition of identifiable data:
1.
How long will you store copies of records or other identifiable data?
2.
How will you dispose of copies of records or other identifiable data?
3.
If there are no plans to dispose of some or all of the identifiable data, please explain
why.
78
C.
Approximate date of study completion:
D.
Will you require followback investigations based on information provided by Erie County
Department of Health records to obtain additional information from decedent’s next-of-kin,
study subjects, physicians, hospitals, and/or other individuals or facilitates mentioned in the
records?
YES
NO
If YES, briefly describe the following:
1.
Types of followback respondents to be contacted. (If the answer to this question
includes families, next-of-kin, or the study subject, please answer the following
questions 2 and 3.)
2.
Information to be obtained from respondents. (A copy of the survey form or ques
tionnaire must also be attached and labelled appropriately).
3.
Methods to be used in conducting such investigations. (A copy of consent form
and initial contact letter to be mailed to followback individual must also be
attached and labelled appropriately.)
19
E.
Will any of the identifiable data obtained from the records and/or followback investigations
be used as a basis for legal, administrative, or other actions which may directly affect
particular individuals as a result of their specific identification in this project?
YES
NO
If YES, Please explain.
F.
Will the identifiable data obtained from the records or followback investigations be used
either directly or indirectly for any project or purpose other than the one described in Pan
V?
YES
NO
If YES, briefly describe the other research project(s) or purpose(s) for which the data will be
used. A separate application form must be submitted for each project which will be using
protected data obtained from Erie County Department of Health records.
80
IX.
applicant assurances
The undersigned hereby agrees to the following terms and conditions related to this application and
to the use of information obtained from the Erie County Department of Health.
A.
The identifiable data obtained following written approval from the Department of Health
shall be used only for the study proposed and the purposes described in the “Summary of
Study Protocol or Project Activities” (Part V) and in the “Employee Registry Description”
(Part VI). Use of the information for a project or purpose other than that described in Parts
V and VI shall not be undertaken unless a separate application form for the subsequent
project has been submitted to, and approved by, the Erie County Department of Health.
B.
No individually identifiable data shall be released without prior written approval by the Erie
County Department of Health.
c.
If data extracted from Erie County Department of Health records are used in any
publication, the following statement must be included in such publication or any other
release of the data:
These data were supplied by the Erie County Department of Health, Erie County
Department of Health, Harrisburg, Erie County Department of Health. The Erie
County Department of Health specifically disclaims responsibility for any analyses,
interpretations or conclusions.
A copy of any published materials or study results should be made available to the Erie
County Department of Health upon request.
D.
I have thoroughly reviewed the contents of the User's Guide for Access to Protected Data
dated October, 1996, which are incorporated herein by reference, and I shall adhere to the
guidelines set forth therein.
E.
All statements entered in this application are true, complete, and correct to the best of my
knowledge and belief.
Project Director’s Name
Project Director’s Title
Organization
Signature
Date
81
ATTACHMENT A
ERIE COUNTY DEPARTMENT OF HEALTH
APPLICATION FOR ACCESS TO PROTECTED DATA
SUPPLEMENTAL ASSURANCES FORM
A separate Supplemental Assurances Form (pages 12-15) must be completed and signed by EACH organization listed
on page 3 of the application form as participating in this study. The Supplemental Assurances Form(s) must then be
submitted as an attachment to the application form. Additional copies of pages 12-15 may be made as required.
Name:
Title:
Organization:
Street Address or P.O. Box:
City, State, Zip Code:
Telephone:
(area code)
A.
How will you maintain the confidentiality and security of identifiable data obtained from the
Department of Health records? (Identifiable data refers to any information which could permit the
identification of any individual. This is not only name and address, but also individual case record
data where other demographic items such as age, sex, race, and place of residence could possible be
used to identify subjects.)
B.
Disposition of identifiable data:
1.
How long will you store copies of records or other identifiable data?
2.
How sill you dispose of copies of records or other identifiable data?
3.
If there are no plans to dispose of some or all of the identifiable data, please explain why.
82
C.
Approximate date of study completion:
D.
Will you require followback investigations to obtain additional information from decedent’s next-of-kin,
study subjects, physicians, hospitals, and/or other individuals or facilities mentioned on the records?
YES
NO
If YES, briefly describe the following:
1.
Types of followback respondents to be contacted. (If the answer to this question includes
families, next-of-kin, or the study subject, please answer the following questions 2 and 3.)
2.
Information to be obtained from respondents. (A copy of the survey form or questionnaire
must also be attached and labelled appropriately.)
3.
Methods to be used in conducting such investigations. (A copy of consent form and initial
contact letter to be mailed to followback individual must also be attached and labelled
appropriately.)
83
E.
Will any of the identifiable data obtained from the records and/or followback investigations
be used as a basis for legal, administrative, or other actions which may directly affect
particular individuals as a result of their specific identification in this project?
YES
NO
If YES, please explain.
F.
Will the identifiable data obtained from the records or followback investigations be used
either directly or indirectly for any project or purpose other than ;the one described in Part
V of the Application for Access to protected Data?
YES
NO
If YES, briefly describe the other research project(s) or purpose(s) for which the data will be
used. A separate application form must be submitted for each project which will be using
protected data obtained from Erie County Department of Health records.
84
APPLICANT ASSURANCES
The undersigned hereby agrees to the following terms and conditions related to this application and to the use of
information obtained from ±e Erie County Department of Health.
A.
The identifiable data obtained following written approval from the Department of Health shall be used only for the
study proposed and the purposed described in the "Summary of Study Protocol or Project Activities” and “Em
ployee Registry Description: (Parts V and VI of the Application for Access to Protected Data). Use of the infor
mation for a project or purpose other than that described in Parts V and VI shall not be undertaken unless a separat
application form for the subsequent project has been submitted to, and approved by, the Erie County Department or
Health Department
of Health.
B.
No individually identifiable data shall be released without prior written approval by the Erie County Department or
Health.
C.
If data extracted from Erie County Department of Health records are used in any publication, the following
statement must be included in such publication or any other release of the data:
These data were supplied by the Erie County Department of Health, Erie County Department of Health,
Harrisburg, Erie County Department of Health. The Erie County Department of Health specifically
disclaims responsibility for any analyses, interpretations or conclusions.
A copy of any published materials or study results should be made available to the Erie County Department of
Health upon request.
D.
I have thoroughly reviewed the contents of the User’s Guide for Access to Protected Data dated October, 1996,
which are incorporated herein by reference, and I shall adhere to the guidelines set forth therein.
E.
All the statements entered in this application are true, complete, and correct to the best of my knowledge
and belief.
Name
Title
Organization
Signature
applic-doc l/!3/98/»k
Date
85
COUNTY OF ERIE
Department of Health
JuChn M. Lyncn
Ccxjnty Executtve
606 West Second Street
Erie. Pennsytvcnia 16507
814/451-6700
Fax: 814/451-6767
Jo*eon IrzyoruJa
Ontcror
ERIE COUNTY BOARD Of HEALTH
SnxwyJ-Zogor>d
V*nc*nri_ Jonco. D.O.
^0*00 A Noowomy. M.O.
0. Zum
Bonrra K. Book*
Application Review Committee
The following committee members have reviewed and approved the contents of the
attached application. The committee reviewed the application for the proper and secure
use of identifiable data and assure proper disposal of data as stated in the proposal at the
end of the study . No identifiable data will be released. The principal investigator has
signed the applicant assurance statement of the application.
The Erie County Deparment of Health and Review Committee specifically disclaim
responsibility for any analyses, interpretations or conclusions. A copy of any published
material or study results will be made available to the Erie County Department of Heal±.
The review committee and principal investigator has reviewed the Users Guide for
Access to Protected Data which are incorporated herein by reference, and shall adhere to
the guidelines set forth therein.
Title of Study:.
Principal Investigator:.
Signature:
Reason for Study:.
Date of Review by Committee:.
.*
Approved by:
Signature
t
Date
/
Charlotte Berringer, Director
Personal Health Services
Erie County Department of Health
__ f
/.
Nancy K. Rea, Public Health Administrator
Administration
Erie County Department of Health
I
Joseph Trzybinski, Director
Administration
Erie County Department of Health
Signature
Date
Signature
__ /_
Date
Public Health is an Organized Community Effort Aimed at Preventing Disease,
Prolonging Ute, and Improving Emotional and Physical Efficiency.
Appendix B
86 ’
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Appendix C
92
ERIE COUNTY DEPARTMENT OF HEALTH
STD CLINIC PATIENT CONSENT FORM
I
___________________ grant permission to the ERIE COUNTY DEPARTMENT
OF HEALTH to obtain specimens, perform treatments and share information about
myself, or my child
______ as may be necessary for proper medical care,
so long as I understand the procedures.
Date
Patient Signature
Witness
Date
Patient Signature
Witness
Date
Patient Signature
Witness
Date
Patient Signature
Witness
Date
Patient Signature
Witness
Date
Patient Signature
Witness
Date
Patient Signature
Witness
Date
Patient Signature
Witness
Date
Patient Signature
Witness
Date
Patient Signature
Witness
Date
Patient Signature
Witness
c:klsidcon.96
Z X ct
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Appendix D
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