Hepatitis B Seronegative
Commonalties in Health Care Workers
University of Detroit
Mercy
Running Head: Seronegative
Commonalties
Statement of Problem
Purpose
Background / Significance of Study
Summary
Hypothesis
Definitions
Review of Literature
Theoretical Framework / Rationale
Study and Analysis of Data
General Design and Procedures
Sample
Test Instrument
Procedures for Data Collection
Procedures for Data Analysis
Limitations
Style Manual
References
Appendix I
Appendix II
Appendix II - With Sample Data
Statement of Problem
Purpose
The purpose of this research is to
determine which commonalties exist among healthcare workers (HCW/S)
who failed to become seropositive following the initial series
of hepatitis B virus (HBV) immunizations. Seropositivity, for
the purposes of this research, will be defined as a measurable
antibody titer of greater than 10 mIU per milliliter, Collier,
A.C., Corey, L., Murphy, V.L., Handsfield, H.H., (1988), 30 -
60 days post final injection. The initial series of immunizations
will be defined as 20 micrograms of recombinant hepatitis B vaccine
injected into the deltoid muscle at intervals of 0, 1, and 6
months.
These research data will be analyzed
and used to construct new dynamic treatment protocols that will
take into consideration the differences in age, body mass index,
and several other factors. Body mass index is the person's weight
in kilograms divided by the square of their height in meters.
Studies have shown that patients whose BMI exceeds 29 are less
likely to seroconvert during the first round than those whose
BMI is equal to 28 or less, Craven, D.E., Awdeh, Z.L., Kunches,
L.M., Yunis, E.J., Dienstag, J.L., Werner, B.J. et al (1986).
Employing this type of preemptive treatment will reduce the costs
incurred with reimmunization by preventing unscheduled return
visits, minimize the delay that the HCW experiences in attaining
seropositivity, and therefore, provide a safer environment for
patients.
A personal health history with demographic
and age information, and a complete description of the immunization
regime, will be compiled from the questionnaire or their immunization
histories and will be included in the results.
Background and Significance of
Study
Hepatitis B as an occupational hazard
is well documented (Iserson, 1985). The prevalence of serologic
markers for this disease in the general population is less than
5 %. However, in medical and dental
workers it is significantly higher: 16 % in general dentists,
28 % in surgeons, 23 % in anesthesia personnel, and 30 % in emergency
department nurses, Wood, R.C., Macdonald, K.L., White, K.E.,
Hedberg, C.W., Hanson, M., Osteoholm, M.T., (1993). The risk
of transmission of HBV to nonimmune health care workers after
exposure is proportional to the level of the virions in the contaminant
and correlates with the presence or absence of hepatitis B e
antigen (HBeAg) in the source patient. (Wood et al, 1993) reported
that the recommended series of three intramuscular doses of hepatitis
B vaccine illicits a positive seroconversion rate in 90 % of
healthy adults and 95 % of infants, children and healthy adolescents,
(Wood et al, 1993).
Hepatitis B is caused by a DNA virus,
and the intact virus is called the Dane
particle. The
virus has three major structural antigens: surface antigen [
HBsAg]; core antigen [HBcAg] and e antigen [HBeAg]. Transmission
of hepatitis B occurs primarily as a result of parenteral exposure,
sexual contact, and perinatal exposure (ACOG Technical Bulletin,1992).
Additionally, certain population groups have an increased prevalence
of hepatitis B such as Asians, Eskimos, drug addicts, transfusion
recipients, dialysis patients, residents and employees of chronic
care facilities, prisoners, and recipients of tattoos (ACOG Technical
Bulletin,1992).
Patients with acute and chronic hepatitis
B infection pose a major threat to transmission to other household
members, especially their sexual partner. In addition, infected
women may transmit infection to their fetus. Perinatal transmission
occurs primarily as a result of the infant's exposure to infected
blood and genital secretions during delivery. In the absence
of immunoprophylaxis for the neonate, perinatal transmission
occurs in 10-20 % of women who are seropositive for both HBsAg
and HBeAg (CDC:MMWR, 1990).
A combination of passive and active
immunity is highly effective in preventing both horizontal and
vertical transmission of hepatitis B infection. All individuals
who have household or sexual exposure to another person with
hepatitis B infection should be tested to determine if they have
the antibody to the virus. If they are seronegative, they should
immediately receive immunoprophylaxis with hepatitis B immunoglobulin
[ HBIG] 0.06 ml/kg IM. They should also receive the hepatitis
B vaccination series. Additionally, infants who are delivered
to seropositive mothers should receive HBIG, 0.5 ml IM, immediately
after birth. Then they should begin the hepatitis B series within
12 hours of birth.
Neonatal prophylaxis is 85 to 95
% effective in preventing neonatal hepatitis B infection. The
Center for Disease Control and Prevention (CDC) recently recommended
universal hepatitis B vaccination for all infants. Dosage recommendations
vary depending on the mother's serostatus. Infants born to seronegative
mothers require only the vaccine. Infants born to seropositive
mothers should receive both the vaccine and HBIG. Therefore,
obstetricians must continue to screen all of their patients for
hepatitis B at some point during pregnancy. Selective screening
on the basis of acknowledged risk factors will fail to identify
30 to 50 % of seropositive women. (ACOG Technical Bulletin,1992).
Patients infected with hepatitis B virus also may transmit infection
to medical and nursing personnel who care for them. Each year
approximately 12,000 American health care workers contract hepatitis
B as a result of an occupational injury such as a needle stick
or splash to a mucous membrane. Of these, approximately 200 develop
fulminant hepatitis and subsequently die. Jagger, J., Hunt, E.H,
Brand-Elnaggar, J. (1988).
Health care workers can protect themselves
from hepatitis in three principal ways. First, they should be
vaccinated for hepatitis B. Second, they should encourage all
young adults and other individuals who have a specific risk factor
to receive the hepatitis B vaccine. Third, they should consistently
follow universal precautions to prevent sharp injuries and splashes
to exposed mucous membrane or skin surfaces.
This information is particularly
important for physician assistants because of their emerging
role in the delivery of invasive health care services and performance
of invasive procedures. For example, suturing in the Emergency
Room setting and "first assisting" in Surgery. I would
estimate that their eventual level of infection would lie somewhere
in between that of the nursing and physician personnel.
Conversely, health care workers who
are infected with hepatitis B also pose a risk to others. They
must observe safeguards to prevent horizontal transmission of
infection to their patients. Infection is most likely to occur
as a consequence of direct blood-to-blood exposure during invasive
surgical procedures. Unless the patient has documented immunity
to hepatitis B, the infected health care worker has an ethical
obligation to inform that some risk of transmission exists. The
provider should then perform the procedure only if the patient
explicitly consents. During the actual procedure, the provider
must take every precaution, including double gloving, to ensure
that a sharp injury does not occur.
The purpose of this research is to:
1. Determine existing commonalties
between nonconverters.
2. Allow the providers of the vaccine
to customize the immunization protocols to compensate for the
commonalities and make the appropriate changes in immunization
regime to convert the healthcare workers with the first round
of immunizations.
It is possible that although these
nonconverters exhibit less than the 10 mIU per milliliter of
HBsAg, they may still be immune to the effects of the hepatitis
B virus. Craven and colleagues (1986) reported that no increased
frequency of chronic infection was seen among vaccine nonresponders
who became infected with hepatitis B virus. This may be due to
the their own "super-efficient" immune system's ability
to protect them from the virus and to reduce the levels of the
antibody to nonmeasurable levels or specific human leukocyte
characteristics. It has also been suggested by Craven that persons
who initially convert and then demonstrate nonmeasurable levels
of the antibody may still be protected due to an anamnestic response.
An anamnestic response is one that is also described as immunologic
memory. Further discussion of these theories is beyond the scope
of this proposal and should be studied at a later time.
Summary
Many efforts have been made to qualify
and quantify the basis for seronegative responses to hepatitis
B immunization. Studies that have been done have been broken
down into two primary categories: those that study the vaccine
and the injection methodology and those that study individual
patient characteristics. The purpose of this research is to compile
information so that health care providers can design and implement
hepatitis B immunization programs that improve the success rate
from its current 90 % for adults on the initial attempt to 95
% within 2 years of implementation.
Hypothesis
The objective of this proposal is
to obtain data that enables the members of the academies of the
individual disciplines to make recommendations and to design
immunization protocols to improve the existing 90 % initial seroconversion
rate to 95 % within two years of implementation. The various
academies could include, but not be limited to, the American
Academy of Pediatrics and the American College of Obstetricians
and Gynecologists.
1. Commonalities exist between serial
nonconverters. Providers of the vaccine will customize the immunization
protocols to compensate for the commonalities and make the appropriate
changes in immunization regime to convert the healthcare workers
with the first round of immunizations.
2. 95% of the health care workers
vaccinated will seroconvert during the first round of immunization
if four 20 microgram doses are injected into the deltoid on a
schedule of 0,1, 6 and 7 months instead of 0,1, and 6.
Definitions
The following operational definitions
describe terms used in this research:
1) Seroconversion and Seropositivity
- for the purposes of this research, will be defined as a measurable
antibody titer of greater than 10 mIU per milliliter (Collier
et al, 1988), 30 - 60 days post final injection.
2) Initial Immunization Series -
The initial series of immunizations will be defined as 20 micrograms
of recombinant hepatitis B vaccine injected into the deltoid
muscle at intervals of 0, 1, and 6 months.
3) Body Mass Index - Body Mass Index
is equal to the weight of the person in kilograms divided by
the square of their height in meters.
Chapter II
Review of the Literature
Theoretical Framework and Rationale
The seriousness of hepatitis B (HBV)
as an occupational hazard to health care workers is well documented
(Iserson, 1985). The prevalence of serologic markers for this
disease in the general US population is less than 5 %. However
in medical and dental workers it is significantly higher: 16
% in general dentists, 28 % in surgeons, 23 % in anesthesia personnel,
and 30 % in emergency department nurses (Wood et al, 1993).
At the October 1983 American College
of Emergency Physicians (ACEP) Scientific Assembly attendees
were given an opportunity to participate in a hepatitis B serosurvey.
Those physicians who had already received hepatitis B vaccine
were excluded from participation. A total of 1,252 emergency
physicians and emergency medicine residents attended the three-day
conference. Nearly 25 % of the attendees (316) participated in
the voluntary screening.
Each participant was asked to complete
a short questionnaire prior to having a 15-cc blood specimen
drawn. Information gathered on the questionnaire included type
of staff position (teaching, community physician, resident),
age, sex, and years of practice in emergency medicine. Participants
also were asked to provide information about the number of
hours worked per week, the number of emergency department visits
annually, geographic location (inner city vs suburban) and classification
of their institutions (community vs university).
Due to the variety of physicians
present, information was sought on country of birth, and the
type of institution worked. A nationwide laboratory service (MetPath,
Inc) performed the on-site phlebotomy and processing of blood
samples.
Frequency distributions were established
for all questionnaire and laboratory results, and were then crosstabulated
to provide more specific information regarding past exposure,
risk factors, type of position, and serologic markers. A chi
square test was applied to all results as a test of significance.
Of the 316 physicians participating
in the serostudy, 99 (31 %) were emergency department teaching
faculty, 184 (58 %) were community emergency physicians, and
33 (11 %) were emergency medicine residents. A majority of the
participants (59 %) were between 30 and 39 years of age; (89)
% were male; and 54 % had been in practice for six or more years.
Only 6 % of the participants indicated a history of any type
of hepatitis.
Of the group indicating no prior
hepatitis infection (n=297), 20 (6.8 %) had serologic evidence
of anti-HBs, three (1 %) had anti-HBc only, 15 (5 %) had both
anti-HBs and anti-HBc, and one (0.3 %) had HBsAg alone. The overall
prevalence of HBV markers in this group was 13 % (39/297). No
statistically significant difference was found among teaching
faculty, community physicians, and emergency medicine residents.
No statistically significant differences
were obtained from analyzing the following variables: age, sex,
years in emergency medicine, years in other medical specialties,
hours worked per week, number of emergency department patient
visits annually, and type of hospital (suburban vs inner city,
community vs university. An analysis was done on each group separately
and the entire group of participants together. Data obtained
from questions regarding country of birth (US, Canada, other)
and type of institution (hospital vs free-standing clinic) were
incomplete and therefore were not analyzed. In addition, no useful
information was derived from analysis of risk factors; homosexuality,
use of "street' drugs, blood transfusions, etc.
Currently the United States contains
a pool of HBV chronic carriers estimated to be between 400,000
and 800,000. The majority of these persons are completely unaware
of their condition with no recognizable symptoms. Because these
people, as well as those with known or suspected HBV infections,
are in the pool of potential emergency department patients, establishing
the risk status of the emergency physician becomes important.
The 15.5 % overall prevalence of
HBV serologic markers found in emergency physicians is approximately
half that of the nurses with whom these physicians work, yet
it was nearly equal to that of paramedical personnel and was
five times that of the general population. The higher levels
of nursing infection are perhaps due to the increasing role of
nursing staff in triage situations with blood and body fluids
in the emergency departments. With this in mind, HBV should
be considered an occupational hazard for emergency physicians,
paramedic personnel and nursing staff, and evidence of active
immunization against HBV should be considered by all members
of the specialty.
In a related study, (Craven et al,
1986), twenty-eight health care workers who had a poor antibody
response when initially vaccinated with hepatitis B vaccine were
revaccinated with three additional 20-microgram doses. Eight
of the twenty nonresponders, who had levels of antibody to hepatitis
B surface antigen (anti-HBs) of less than 8 estimated radioimmunoassay
(RIA) units, and all 8 of the hyporesponders, who had anti-HBs
levels of 8 or 16 RIA units, attained anti-HBs levels of 36 RIA
units or more after revaccination. Tests for HLA-A, B, C, and
DR; for complement proteins C2, C4A, C4B, and BF; and for the
erythrocyte enzyme glyoxalase I were done in 17 nonresponders
and 3 hyporesponders. Nine (45 %) had HLA-DR7 and 8 (40 %) had
HLA-DR3, compared with an expected rate of 23 % in the general
population. At least one of two extended haplotypes (B44, DR7,
FC31 or B8, DR3, SC01) were detected in 6 of the 9 who did not
respond to revaccination, compared with 2 of 11 who responded
to a second course of vaccine.
The proper functioning of the immune
system depends on its ability to recognize "self" from
"nonself". The distinction is achieved by the major
histocompatibility complex, (MHC), or Human Leukocyte Antigen,
(HLA) as it is known in humans. These HLA types are important
because there presence or deficit may provide a foundation for
research into nonresponsiveness to hepatitis B vaccine. Additionally,
their presence may be a highly specific indicator for certain
diseases. For example, there is an 88% risk factor for developing
anklylosing spondylitis in individuals that are found to have
the HLA-B27 antigen.
Because HBV infection is. an occupational
hazard for health care workers who have long-term or continuous
exposure to human blood and many of the infections caused by
hepatitis B virus are subclinical and not associated with an
easily identifiable source of infection, efforts have been directed
at active immunization with hepatitis B vaccine before exposure.
Studies of hepatitis B vaccine in
health care personnel and other high-risk groups indicate
that the vaccine is safe, effective, and immunogenic. In each
of the controlled trials of plasma-derived hepatitis B vaccine
in the United States, a small group of participants have
either failed to respond or responded poorly (achieving low levels
of antibody) (Szmuness, et al., 1982)
In the Boston Inter-Hospital Hepatitis
B Vaccine Study, 666 health care workers were vaccinated, and
28 (4.2 %) had absent or poor antibody responses (Dienstag, et
al, 1984). This study examined factors related to vaccine nonresponsiveness
in health care workers. Demographic characteristics, response
to revaccination, indicators of immune responsiveness, and genetic
markers were evaluated. These findings suggest that genes present
in the major histocompatibility complex may modulate the immune
response to hepatitis B vaccine and that health care personnel
who have low antibody levels or no response to initial course
of hepatitis B vaccine may benefit from revaccination.
All the volunteers in this study
were health care workers that had been vaccinated with three
20-ug doses of hepatitis B vaccine intramuscularly in the deltoid
region at 0, 1, and 6 months. Nonresponders and hyporesponders
were defined by the level of antibody achieved. Each person was
revaccinated with three 20-ug doses of vaccine intramuscularly
in the deltoid region (doses four to six) at 0, 1, and 6 months.
The mean (+ SD) interval between primary vaccination and
revaccination was 18 + 4 months. Informed consent was
obtained for each participant, and the protocol was approved
by the Institutional Review Board at Boston City Hospital.
The 631 responders to the initial three doses of hepatitis B
vaccine did not differ significantly in age, sex, or race from
the 8 hyporesponders and the 20 nonresponders. In addition, there
were no significant differences between the three groups in
country of origin, time in occupation, recent identified
exposure to HBV, recent transfusions or occupational category
in the hospital.
This Hepatitis B vaccine is composed
of purified hepatitis B surface antigen (HBsAg) prepared from
the plasma of persons who are chronic HBsAg carriers. Several
factors are known to be associated with diminished antibody responsiveness
to vaccination. The immune response is excellent in infants,
children, and young adults but decreases with advancing age (Mclean
et al., 1984). Patients with renal failure or immunosuppression
have a poor humoral response to vaccination ,Stevens, C.E., Alter,
H.J., Taylor, P.E., Zang, E.A, Harley, E.J., Szmuness, (1984).
Nonresponsiveness has also been attributed to freezing the vaccine
before administration, Francis, D.P., Hadler, S.C., Thompson,
S.E., (1982) and to injection of the vaccine into the buttock
rather than the gluteal region (CDC:MMWR: 1985). Vaccine nonresponders
in this study were healthy health care workers who originally
had participated in the Boston Inter-Hospital Hepatitis B Vaccine
Study, in which the overall response rate was 96 % and the geometric
mean titer of anti-HBs was 6300 RIA units. More than 79 % of
the responders to hepatitis B vaccine developed levels of anti-HBs
of 10000 RIA units and more than 43 % had levels that exceeded
100,000 estimated RIA units (Dienstag et al, 1984). Although
responders to the vaccine in this study were younger than nonresponders
and hyporesponders, the differences were not statistically significant.
All injections of vaccine were given intramuscularly in the deltoid
region, and the vaccine was stored according to the manufacturer's
instructions. All of the subjects with poor responses to hepatitis
B vaccine had no obvious defect in delayed skin test hypersensitivity
or altered ratios of T-cell phenotypes.
All 8 hyporesponders and 9 of the
20 nonresponders in the study developed levels of anti-HBs of
36 RIA units or more after revaccination. Because 6 nonresponders
follow-up after receiving dose six, the response rate to revaccination
could range from 45 % to 65 %.
By comparison, Kalish in his 1985 study reported a 20 % rate
of hyporesponsiveness among 200 homosexual men initially vaccinated
with hepatitis B vaccine. As noted in this study, the response
rate was higher for hyporesponders than nonresponders. However,
Kalish found that the poor responses to vaccination in homosexual
men were coorelated with a higher frequency of IgM antibody against
cytomegalovirus, as well as increased numbers of sexual contacts
and more sexually transmitted diseases, than in homosexual men
who responded.
In conclusion, hepatitis B is a serious
problem for healthcare workers. The data suggest that its virulence
is directly related to length of exposure and types of exposure
to seropositive patients. Health care workers may also present
a serious hazard to patients. However, patients' serostatus is
a variable that cannot be controlled preemptively. All healthcare
workers that come into contact with blood, blood products, sera
or genital secretions of potentially serpositive patients should
be immunized against the virus.
Healthcare workers that are immunized
will generally respond on average 90 % of the time to the first
round of immunizations. Approximately five additional % shall
respond to an additional 20 microgram injection into the deltoid
muscle. The data also suggest that those healthcare workers that
do not respond may have a genetic predisposition or physical
reason for not doing so, including, but not limited to, age,
weight, and BMI. Tests for HLA-A, B, C, and DR; for complement
proteins C2, C4A, C4B, and BF; and for the erythrocyte enzyme
glyoxalase I were done in 17 nonresponders and 3 hyporesponders.
Nine (45 %) had HLA-DR7 and 8 (40 %) had HLA-DR3, compared with
an expected rate of 23 % in the general population. At least
one of two extended haplotypes (B44, DR7, FC31 or B8, DR3, SC01)
were detected in 6 of the 9 who did not respond to revaccination,
compared with 2 of 11 who responded to a second course of vaccine.
Chapter III
General Design and Procedures
The general design of this research
project will be a retrospective-cohort questionnaire. It will
be completed by Infection Control Staff. The questionnaire will
consist of approximately twenty-five (25) multiple choice questions
referring to age, occupation, ethnic, social and demographic
data. The results of these questions will be used to determine
the seronegative commonalities of the participants. The questions
will be arranged in the following order; vaccine and technique
related questions and patient related questions. Respondents
will choose the single most appropriate answer to the question.
Open-ended questions shall be avoided when possible.
This study is retrospective-cohort
in nature because it derives its data from preexisting sources
and does not control specific variables.
Sample
The data will be generated from the medical records of two-hundred
(200) health care workers who received the first series of 0,1,6
month immunizations and failed to become seropositive when tested
30-60 days post final injection.. They participants shall range
in age from twenty one to sixty five years of age. Notice will
be given to the participants that all data generated and used
are confidential and will be used only for the purposes of this
study. ( See Appendix I for questionnaire )
To be included within the studied
group, the individuals must:
1. Be willing to participate in the study.
2. Have been employed in the direct contact of patients for the
previous 12 months.
3. Have failed to become seropositive after the initial series
of hepatitis B immunizations.
Informed Consent
Informed consent shall be obtained from the survey participants
and shall be obtained by the survey facilitator when the serial
nonresponders have been identified.
To be excluded from the study group, participants must:
1. Decline to participate in writing once notified
2. Be less that sixteen years of age.
Test Instrument
The Seronegative Commonalities Questionnaire was designed for
this study by the author of this research. The questionnaire
will be experimental in nature. Contained within this questionnaire
is a general background information questionnaire.
Procedures for Data Collection
Questionnaires will be mailed to Infection Control Directors
/ Nurses who had previously consented to participate and the
data shall be compiled from the records of those participants
who failed to convert during the initial immunization process.
The questionnaires shall be sent in three groups. The hospitals
in Group I shall have from 500 - 1000 beds; and receive 67 questionnaires,
Group II, 250 - 500 beds; 67 questionnaires; and Group III, 50
- 250 beds; 66 questionnaires (n=200). Questionnaires shall be
completed and returned to the facilitator via insured mail. Returned
questionnaires will be logged and assigned a random identification
number (RID), and filed until all of them are returned or until
the allocated time period is over. The total time period for
the study will not exceed 365 days. All data will be summarily
analyzed.
Procedures for Data Analysis
Upon receipt of completed questionnaires
identification numbers will be recorded and logged.
Data from questionnaires will be
compiled as follows:
Type of Vaccine Recombinant ¨ vs Plasma
derived ¨
Vaccine Storage Fresh ¨ vs Frozen virus ¨
Lot Number ____________
Injection Site Deltoid ¨ vs Gluteal injection ¨
Dosage 10 ul ¨ 20 ul ¨
Other ¨
______
Verification of Doses 0 ¨ 1 ¨ 6 ¨ month intervals
Kidney function (If Available) Serum Creatinine______
HIV status Positive ¨
Negative ¨
IVDA Positive ¨ Negative ¨
Sexual Preference Heterosexual ¨
Homosexual ¨
Blood Type a ¨
b ¨
ab ¨
o ¨
- ¨
+ ¨
Health Care Occupation __________________________
Number of years in Occupation _______years
Recent exposures to hepatitis B Positive ¨
Negative ¨
Number of Days since exposure __________________
Cytomegalo Virus? Positive ¨
Negative ¨
Age ______years
Weight _____pounds / _______kgs
Height ___ft ___inches / _meters __cm
Gender Male ¨ Female
¨
Inhalants Nonsmoker ¨ Smoker ¨
Countries of National Origin ____________________________________
Comments ________________________________________________________________________________________________________________________________________________________________
Presenting data shall be compiled
using the seronegative commonalties worksheet, (see Appendix
II.) Factors that negatively or positively influence the seroconversion
rate shall be trended and then compensated for during the initial
immunization protocols for new vaccinees. For example, if the
data support the assumption that a majority (>50 %) of male
smokers older than 45, whose BMI exceeds 29 fail to become seropositive;
then future patients with the same profile should be a candidate
for four injections of the hepatitis B vaccine instead of the
usual three. This additional injection would consist of a single
20 microgram dose be given in the deltoid muscle. The complete
schedule would be an injection given at 0,1,6 and 7 months.
Limitations
Since this is a self-designed instrument,
no claims are made for its reliability or validity. If the questions
are answered accurately it will address the underlying question
of the seronegative commonalities questionnaire, namely, what
common traits do health care workers have that fail the initial
round of immunization for hepatitis B?
As the sample size increases, the sampling distribution of the
mean can be approximated by the "normal or bell-shaped distribution".
This is true regardless of the distribution of the individual
values in the population. Statisticians have found that regardless
of how nonnormal the population distribution is, once the sample
size is at least 30, the distribution of the mean will be approximately
normal. General assumptions can then be made about the sample
relative to the overall population.
The style manual for this proposal
is
The Publication Manual
of the American Psychological
Association.
Fourth Edition, Pridemark Press,
Inc.
Baltimore, 1994
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Appendix I
Questionnaire for Infection Control
follow-up of Serial nonconvertors
Please indicate with the appropriate
response the answer to the following questions, use a checkmark
or fill in the blank with the appropriate information.
RID NUMBER___________________
1. Type of Vaccine Recombinant ¨ vs Plasma
derived ¨
2. Vaccine Storage Fresh ¨ vs Frozen
virus ¨
3. Lot Number ____________
4. Injection Site Deltoid ¨ vs Gluteal
injection ¨
5. Dosage 10 ul ¨
20 ul ¨
Other ¨
______
6. Verification of Doses 0 ¨ 1 ¨ 6 ¨ month
intervals
7. Kidney function(if available)
Serum Creatinine______
8. HIV status Positive ¨ Negative
¨
9. IVDA Positive ¨
Negative ¨
10. Sexual Preference Heterosexual
¨ Homosexual
¨
11. Blood Type a ¨
b ¨
ab ¨
o ¨
- ¨
+ ¨
12. Health Care Occupation __________________________
13. Number of years in Occupation
_______years
14. Recent exposures to hepatitis
B Positive ¨ Negative
¨
15. Number of Days since exposure
__________________
16. Cytomegalo Virus? Positive ¨ Negative
¨
17. Age ______years
18. Weight ______pounds / _______kgs
19. Height ___ft ___inches / _meters
__cm
20. Gender Male ¨
Female ¨
21. Inhalants Nonsmoker ¨ Smoker
¨
22. Countries of National Origin
__________________________
23. Comments ___________________________________________________________