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Glossary of Terms
A
Adsorbed vaccine. See Vaccine, pertussis v., adsorbed
[USP].
Anaphylaxis. Generalized anaphylaxis is an acute, often
explosive, systemic reaction characterized by pruritus, generalized
flush, hives, respiratory distress, and vascular collapse and,
occasionally, by seizures, vomiting, abdominal cramps, and
incontinence. It occurs in a previously sensitized person who again
receives the sensitizing antigen.
Arthralgia. Pain in a joint or joints.
Arthritis. Inflammation of a joint or joints detectable
as swelling, redness, and tenderness.
Arthropathy. Any joint disease.
Aseptic meningitis. An inflammation of the meninges with
typical changes in the cerebrospinal fluid, including increased
numbers of white blood cells, normal glucose, and absence of
bacteria on examination and culture. The most common causes include
viral infection and noninfectious causes such as lead
poisoning.
Attention deficit disorder (ADD). ADD is a
neurobehavioral disorder in children characterized by three
cardinal symptoms: inattention, hyperactiv
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ity, and impulsivity. Many children with ADD also exhibit
symptoms of a learning disability, and many children with reading
disabilities also exhibit evidence of ADD.
Attributable fraction (exposed). The attributable
fraction among exposed individuals is the proportion by which the
incidence rate of the outcome among those exposed would be reduced
if the exposure were eliminated. It is assumed that causes other
than the one under investigation have had equal effects on exposed
and unexposed groups and that the effects of exposures are
additive.
Attributable fraction (population). The attributable
fraction in the population is the proportion by which the incidence
rate of the outcome in the entire population would be reduced if
the exposure were eliminated. It is assumed that causes other than
the one under investigation have had equal effects on the exposed
and unexposed groups and that the effects of exposure are
additive.
Attributable risk (exposed). The rate of a disease or
other outcome in exposed individuals that can be attributed to the
exposure. This measure is estimated by subtracting the rate of the
outcome (usually incidence or mortality) among unexposed
individuals from the rate among exposed individuals. It is assumed
that causes other than the one under investigation have had equal
effects on exposed and unexposed groups and that the effects of
different causes are additive. This term is often used,
incorrectly, to denote the attributable fraction among exposed
individuals and in the population.
Autism. The condition of being dominated by subjective,
self-centered trends of thought or behavior that are not subject to
correction by external information. One form, infantile
autism, is a condition of the early years of life characterized
by failure to relate in the usual way to people and situations and
by repetitive activities, developmental language disorders, and a
marked inability to adjust socially.
B
Bias. Deviation of results or inferences from the truth,
or processes leading to such deviation. Any trend in the
collection, analysis, interpretation, publication, or review of
data that can lead to conclusions that are systematically different
from the truth. Not to be confused with prejudice or
partisan point of view, as is the conventional usage.
C
Case-comparison study. (Syn: case-control study). A study
that starts with the identification of persons with the disease or
condition (adverse event) of interest and a suitable control
(comparison) group of persons
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without the disease. The relation of an attribute (e.g.,
immunization) to the disease is examined by comparing the diseased
and nondiseased groups with regard to how frequently the attribute
is present, or if quantitative, the levels of the attribute, in
each of the groups.
Cohort study. (Syn: prospective, follow-up study). A
study in which subsets of a defined population can be identified
who are, have been, or in the future may be exposed or not exposed,
or exposed in different degrees, to a factor or factors
hypothesized to influence the probability of occurrence of a given
disease (adverse event) or other outcome. The essential feature of
the cohort design is observation of the population for a sufficient
length of time to generate reliable incidence or mortality
rates.
Controlled study. Controlled studies are studies that use
a comparison group that differs from the subjects of the study in
either disease experience (outcome) or allocation to a regimen
(exposure). Allocation to a regimen can be random, as in a
randomized clinical trial or study, or nonrandom, as in an
observational cohort study or a case-control study.
D
DPT vaccine. See Vaccine, DPT v.
DTP vaccine. See Vaccine, DTP v.
E
Encephalopathy. Refers to a variety of conditions
affecting the brain resulting in alterations in the level of
consciousness, ranging from stupor to coma. At times, febrile
seizures, afebrile seizures, and epilepsy have been considered
components of encephalopathy (see Chapter 4).
Erythema multiforme. An inflammatory eruption
characterized by symmetrical erythematous, edematous, or bullous
lesions of the skin or mucous membranes.
Experimental study. A study in which a population is
selected for a planned trial of a regimen (e.g, immunization) whose
effects are measured by comparing the outcome of the regimen in the
experimental group with the outcome of another regimen in a control
group. Allocation of individuals to experimental or control groups
is ideally by randomization.
G
Guillain-Barrè syndrome. An acute, usually rapidly
progressive form of polyneuropathy characterized by muscular
weakness and mild distal sensory loss.
H
Hemolytic anemia. Anemia caused by lysis of red blood
cells, which leads
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to shortened in vivo survival of red blood cells, and an
inability of the bone marrow to compensate for their decreased life
span.
Hyperactivity (hyperkinesis). See Attention deficit
disorder (ADD).
Hypotonicity, hypotonia. Decreased muscle tone.
Hypsarrhythmia. An electroencephalographic (EEG)
abnormality observed in infants, with random, high-voltage slow
waves and spikes that arise from multiple foci and spread to all
cortical areas. This abnormal EEG pattern may be manifested
clinically by spasms or quivering spells (myoclonus) and may be
associated with mental retardation.
I
Immunization. The process of rendering a subject immune
or of becoming immune. In this report the term has been accepted to
be synonymous with vaccination. See Vaccination.
active i. Inoculation with a specific antigen to induce
an immune response.
passive i. The conferral of specific immunity by the
administration of sensitized lymphoid cells or serum from immune
individuals.
Infantile spasms. A condition characterized by sudden
flexion of the arms, forward flexion of the trunk, and extension of
the legs. The attacks last only a few seconds but may be repeated
many times a day. They are restricted to the first 3 years of life,
often to be replaced by other forms of seizures.
J
Juvenile diabetes. An autoimmune disease characterized
most frequently by low or absent levels of circulating endogenous
insulin (more properly called insulin-dependent diabetes
mellitus).
L
Learning disability. A developmental disability defined
by the discrepancy between a child's ability and his or her
achievement. Learning disability may occur in any domain, but it is
most commonly observed in reading. The terms reading
disability and dyslexia are often used
interchangeably.
M
Masked study. (Syn: blind or blinded study). A study in
which an observer(s) and/or subjects are kept ignorant of the group
to which subjects are assigned, as in an experiment, or of the
population from which the subjects come, as in a nonexperimental
study. When both observer and subjects are kept ignorant, the study
is referred to as a double-masked study. The intent
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of masking is to keep subjects and/or investigators unaware of
knowledge that might introduce bias and, thus, eliminate the
possible effects of bias.
Monitoring System for Adverse Events Following Immunization
(MSAEFI). A passive surveillance system designed and monitored
by the Centers for Disease Control for the purpose of collecting
nationwide data on adverse events temporally associated with
receipt of vaccines purchased with federal, state, or local
government funds.
MSAEFI. See Monitoring System for Adverse Events
Following Immunization.
N
Noncontrolled study. Noncontrolled studies are those that
do not use a comparison group that differs from the subjects of the
study in either disease experience (outcome) or allocation to a
regimen (exposure). Examples include individual and comparative
case series, case reports, and anecdotes.
O
Odds ratio (OR). In studies of adverse events following
immunization, the OR generally refers to the exposure-odds ratio,
which, for a set of case-comparison data, is the ratio of the odds
in favor of exposure among the cases to the odds in favor of
exposure among noncases. Under certain circumstances, usually met
in the study of vaccine-related adverse events, the OR is
considered a good estimate of the relative risk.
P
Parapertussis. An infectious disease caused by
Bordetella parapertussis, a coccobacillus closely
resembling Bordetella pertussis. Parapertussis is clinically
indistinguishable from pertussis, but it is usually milder and less
often fatal.
Peripheral mononeuropathy. A syndrome of sensory, motor,
reflex, and vasomotor symptoms, singly or in any combination,
produced by disease of a single peripheral nerve.
Pertussis (whooping cough). An infectious disease caused
by Bordetella pertussis, a small, nonmotile, gram-negative
coccobacillus. The disease is characterized by catarrh of the
respiratory tract and peculiar paroxysms of cough, ending in a
prolonged crowing, or whooping, respiration. The disease is most
frequently encountered in children, is much more prevalent in cold
weather, and is very contagious.
R
Radiculoneuritis. A combination of peripheral neuropathy
with dorsal root (spinal nerve) pain.
Relative risk (RR). The ratio of the risk of disease or
death among the
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exposed to the risk among the unexposed. Generally derived from
cohort studies.
Reye syndrome. An acute and often fatal childhood
syndrome of encephalopathy and fatty degeneration of the liver,
marked by rapid development of brain swelling, hepatomegaly, and
altered levels of consciousness.
Rubella (German measles). A mild viral infection caused
by an RNA virus classified as a togavirus. The infection is
characterized by a pink, discrete, and confluent macular exanthem
and is usually preceded by rhinorrhea, sore throat, and bulbar and,
occasionally, palpebral conjunctivitis. Arthralgia is common, and
monarticular arthritis occurs in 20 percent of patients, more so
adults than children. Transplacental infection of the fetus in the
first trimester produces developmental abnormalities of the heart,
eyes, brain, bone, and ears in up to 40 percent of cases.
S
Sudden infant death syndrome (SIDS). The unexpected and
unexplained death of an apparently well, or virtually well, infant.
SIDS is the most common cause of death of infants between ages 2
weeks and 1 year, accounting for one-third of all deaths in this
age group.
T
Thrombocytopenia. A decrease in the number of platelets,
the cells involved in clotting. Thrombocytopenia may stem from
failure of platelet production, splenic sequestration of platelets,
increased platelet destruction, increased platelet utilization, or
dilution of platelets.
Thrombocytopenic purpura. Severe thrombocytopenia
characterized by mucosal bleeding and bleeding into the skin in the
form of multiple petechiae, most often evident on the lower legs,
and scattered small ecchymoses (bruises) at sites of minor trauma.
In children, idiopathic thrombocytopenic purpura is usually
self-limiting and follows a viral infection.
V
Vaccination. Inoculation with a vaccine for the purposes
of inducing immunity. In this report the term has been accepted to
be synonymous with immunization. See Immunization.
Vaccine. A material containing live attenuated or killed
microorganisms, or constituents of microorganisms, capable of
eliciting protection against infection.
DPT v. A trivalent vaccine containing diphtheria,
pertussis, and tetanus.
DTP v. See DPT vaccine.
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MMR v. A sterile, lyophilized trivalent vaccine
containing attenuated measles (rubeola), mumps, and rubella
viruses.
pertussis v. [USP]. A sterile bacterial fraction or
suspension, in a sodium chloride solution or other suitable
diluent, of killed pertussis bacilli of a strain or strains
selected for high antigenic efficiency. It is an active immunizing
agent against pertussis.
pertussis v., adsorbed [USP]. A sterile bacterial
fraction or suspension, in a suitable diluent, of killed pertussis
bacilli of a strain or strains selected for high antigenic
efficiency and precipitated or adsorbed by the addition of aluminum
hydroxide or aluminum phosphate and resuspended. It is an active
immunizing agent against pertussis.
rubella v. A sterile preparation of live attenuated
rubella virus.
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Appendixes
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Representative terms from entire chapter:
attributable fraction
