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Page 293
A
Strategies For Gathering Information: Adverse Effects of Pertussis
and Rubella Vaccines
LITERATURE SEARCHES
Electronic Data Bases
Because an important aspect of this study was to examine
available information about specific adverse effects of pertussis
and rubella vaccines, the committee undertook an extensive search
of relevant data bases. Searches were conducted in data bases
available through Dialog, a data base vendor. Eighteen data bases
were searched in all. Six of these were primarily biomedical:
Medline, EMBase, BIOSIS, Life Sciences Collection, Clinical
Abstracts, and De Haen Drug Data. Two were industry oriented:
Pharmaceutical News Index and International Pharmaceutical
Abstracts. Two others were primarily agricultural but included
world health materials: AGRICOLA and Agris International. Six were
either business or general news data bases: ABI/Inform, Trade &
Industry Index, Magazine Index, Courier Plus, Newspaper Index, and
Newsearch. The final two data bases covered legal and regulatory
material: Diogenes and the Legal Resource Index. Each data base was
searched in its entirety.
The first step was a broad, but targeted, search of the National
Library of Medicine's Medline. A simple combination of the
descriptors (subject headings) pertussis vaccine or
rubella vaccine and the subheading adverse effects
produced 589 articles on pertussis vaccine and 363 articles on
rubella vaccine. Comparable searches were then done in the other 17
data bases, using
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OCR for page 293
Page 293
A
Strategies For Gathering Information: Adverse Effects of Pertussis
and Rubella Vaccines
LITERATURE SEARCHES
Electronic Data Bases
Because an important aspect of this study was to examine
available information about specific adverse effects of pertussis
and rubella vaccines, the committee undertook an extensive search
of relevant data bases. Searches were conducted in data bases
available through Dialog, a data base vendor. Eighteen data bases
were searched in all. Six of these were primarily biomedical:
Medline, EMBase, BIOSIS, Life Sciences Collection, Clinical
Abstracts, and De Haen Drug Data. Two were industry oriented:
Pharmaceutical News Index and International Pharmaceutical
Abstracts. Two others were primarily agricultural but included
world health materials: AGRICOLA and Agris International. Six were
either business or general news data bases: ABI/Inform, Trade &
Industry Index, Magazine Index, Courier Plus, Newspaper Index, and
Newsearch. The final two data bases covered legal and regulatory
material: Diogenes and the Legal Resource Index. Each data base was
searched in its entirety.
The first step was a broad, but targeted, search of the National
Library of Medicine's Medline. A simple combination of the
descriptors (subject headings) pertussis vaccine or
rubella vaccine and the subheading adverse effects
produced 589 articles on pertussis vaccine and 363 articles on
rubella vaccine. Comparable searches were then done in the other 17
data bases, using
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using search strategies most appropriate for each. The exact
choice of terms depended on the particular data base, but all terms
related to the concepts of vaccines and adverse effects. For
example, ''whooping cough" might have been used instead of (or in
addition to) "pertussis," or "reactions" might have been used
instead of (or in addition to) "adverse effects."
To further ensure inclusion of relevant material, the two
medical files (Medline and EMBase) were searched using combinations
of the vaccine terms with various specific medical terms or
conditions. For pertussis vaccine, these terms were anemia,
hemolytic; spasms, infantile; Reye syndrome; peripheral nerve
disease; sudden infant death; meningitis, aseptic; diabetes
mellitus; autism; learning disorders or dyslexia;
hyperkinesis; brain; convulsions; encephalitis; and
epilepsy. For rubella vaccine, the specific terms used were
polyradiculoneuritis and arthritis.
Searches were later conducted for the adverse events added to
the committee's charge after the project was under way. For
pertussis vaccine, the added adverse events were anaphylaxis;
erythema multiforme or other rash; Guillain-Barrè
syndrome, including mononeuropathy and
polyneuropathy; protracted inconsolable crying or
screaming; thrombocytopenia; and shock or "unusual
shock-like state" with hypotonicity, hyporesponsiveness,
and short-lived convulsions, usually febrile. For
rubella vaccine, the additional adverse event was
thrombocytopenic purpura. These searches were conducted in a
manner similar to those described above.1
For the searches in the two medical data bases, where the
structure of the data base makes it possible, items found were
sorted according to whether they dealt with human or animal
subjects. Review articles were also noted.
As lists of citations were generated by computer literature
searches, staff, committee members, or both examined them and
ordered abstracts of any that concerned the issues or conditions
being examined by the committee. Upon receiving the abstracts, a
further determination was made by staff and committee as to whether
a particular article might contain information pertinent to the
committee's task. Articles were then obtained for each selected
abstract, and copies were distributed to the appropriate committee
members.
OTHER SOURCES
Other sources of information were used by the committee. These
included reference lists; presentations to the committee at its
public meeting,
1 A more
detailed document entitled "Searches of Electronic Data Bases:
Adverse Events Following Pertussis and Rubella Vacination" is
available from the National Technical Information Service, 5285
Port Royal Road, Springfield, Virginia 22161 (703-487-4650).
Resumès of the librarian who carried out the searches and of
the manager of the National Research Council Library are
included.
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workshop, and committee meetings; and individuals representing
organizations with a special interest in the committee's task.
Reference Lists
Additional information sources included the reference lists of
the articles obtained by the committee and staff. The procedures
for obtaining abstracts and subsequent pertinent articles was the
same as that described above. Particular attention was paid to
citations in review articles, in books and reports with extensive
reference lists (e.g., DPT: A Shot in the Dark [Coulter and
Fisher, 1985, New York: Harcourt Brace Jovanovich] and Vaccine
Supply and Innovation [Institute of Medicine, 1985, Washington,
DC: National Academy Press]) and in papers submitted by presenters
at the committee's public meeting on January 10, 1990, and its
workshop on May 14, 1990 (see boxes).
Presentations
Public Meeting (January 10, 1990)
The committee held a public meeting, Adverse Consequences of
Pertussis and Rubella Vaccines, on January 10, 1990, in Washington,
D.C. Notices of the meeting were sent to more than 800 people.
Fifteen individuals made presentations at the public meeting (see
box), which was attended by approximately 150 people.
Workshop (May 14, 1990)
The committee held a workshop, Possible Adverse Consequences of
Pertussis and Rubella Vaccines, on May 14, 1990, in Washington,
D.C. Approximately 100 people attended. Eleven invited speakers
made presentations at the workshop (see box).
Committee Meeting (May 15, 1990)
On May 15, 1990, the committee heard a presentation from
Jeanette Wilkins, Professor of Pediatrics and Orthopedics,
University of Southern California School of Medicine, entitled "Is
Pertussis Whole-Cell Vaccine a Direct Toxin?" Dr. Wilkins followed
up her presentation by sending the committee an extensive
bibliography of citations on pertussis vaccine and its possible
adverse effects.
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BOX 1
Presentations Made to the Committee, Public
Meeting, January 10, 1990.
Phillip S. Berry, attorney,
Oakland, California. Statement of Phillip S. Berry and Ralph A.
Cohen to Committee to Review the Adverse Consequences of Pertussis
and Rubella Vaccines.
Richard V. Colan, Wauwatosa, Wisconsin.
Presentation to the National Academy of Sciences, Institute of
Medicine Committee on the Nature and Rates of Adverse Reactions to
Pertussis and Rubella Vaccines.
Harris L. Coulter. On Ascertaining the Prevalence
of Vaccine Damage (statement submitted to committee prior to public
meeting but not presented in person).
Charles A. Dinarello, Tufts University School of
Medicine, Boston. Biological Effects of Endotoxin.
Mark R. Geier, medical/legal consultant, Silver
Spring, Maryland. Endotoxin in DPT Vaccines.
Marjorie Grant, Determined Parents to Stop Hurting
Our Tots (DPTSHOT), Beaver Dam, Wisconsin. Statement at Public
Meeting for Comments on Pertussis and Rubella Vaccines.
Rajesh K. Gupta, National Institute of Child
Health and Human Development, Bethesda, Maryland. Adverse Reactions
After Injection of Adsorbed Diphtheria-Pertussis-Tetanus (DPT)
Vaccine Are Not Due Only to Pertussis Organisms or Pertussis
Components in the Vaccine.
Erik L. Hewlett, University of Virginia,
Charlottesville. Pertussis Vaccine Encephalopathy.
Michael Hugo, attorney, Boston. Statement at
Institute of Medicine Public Meeting, January 10, 1990.
Edward A. Mortimer, Jr., Case Western Reserve
University School of Medicine, Cleveland. The Epidemiologic
Evidence Relating DTP to Acute Encephalopathy, Infantile Spasms and
the Sudden Infant Death Syndrome.
Georges Peter, Rhode Island Hospital, Providence.
Possible Adverse Consequences of Pertussis Vaccine: Seizures and
Epilepsy.
Stanley A. Plotkin, Children's Hospital of
Philadelphia. Presentation at Institute of Medicine, January 10,
1990.
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Jeffrey H. Schwartz, attorney,
Washington, D.C. Testimony on Behalf of Dissatisfied Parents
Together (DPT) before the Institute of Medicine Committee on
Adverse Consequences of Childhood Vaccines, January 10,
1990.
Mark E. Thoman, Iowa Poison Control Center, Des
Moines. The Clinical Composite of Severe Pertussis Vaccine
Reactions Following DPT Vaccine Inoculation(s).
Arthur C. Zahalsky, Southern Illinois University,
Edwardsville. Scientific Basis for Including Tests of Acute Phase
Reaction Products in Clinical Protocols Designed to Investigate the
Cause of Adverse Reactions Following Inoculation(s) in Infants with
DTP (ads.) Vaccine.
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BOX 2
Presentations Made to the Committee Workshop, May 14, 1990
Thomas P. Bleck, Rush Memorial
Hospital, Chicago. Time Course of Adverse Events Following Exposure
to Known Neurotoxic and Immunotoxic Agents.
Marie Valdes Dapena, School of Medicine,
University of Miami. Evidence Linking Pertussis Vaccines to Sudden
Infant Death Syndrome (SIDS).
Darryl DeVivo, Columbia Presbyterian Medical
Center. Evidence Linking Pertussis Vaccines to Irreversible
Encephalopathy (Permanent Brain Damage).
Ronald Gabriel, University of California, Los
Angeles. School of Medicine, Evidence Linking Pertussis Vaccines to
Irreversible Encephalopathy (Permanent Brain Damage).
Mark R. Geier, medical/legal consultant, Silver
Spring, Maryland. Implications for Evaluating Possible Neurotoxic
Consequences of Pertussis or Rubella Vaccination.
Stanley Plotkin, Children's Hospital of
Philadelphia. Evidence Linking Rubella Vaccines to Chronic
Arthritis.
Keith Redhead, National Institute for Biologic
Standards and Control, United Kingdom. Variations in Pertussis and
Rubella Vaccine Composition and Implications for Evaluating Adverse
Events Following Vaccination.
Noel R. Rose, Johns Hopkins School of Hygiene and
Public Health. Implications for Evaluating Possible Immunotoxic
Consequences of Pertussis or Rubella Vaccination.
John Sladky, Children's Hospital of Philadelphia.
Evidence Linking Rubella Vaccines to Radiculoneuritis/Peripheral
Neuropathy.
Aubrey Tingle, British Columbia Children's
Hospital, Vancouver. Evidence Linking Rubella Vaccines to Chronic
Arthritis.
Alexander Walker, Harvard School of Public Health.
Evidence Linking Pertussis Vaccines to Sudden Infant Death Syndrome
(SIDS).
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Additional Individuals and
Organizations Who Provided Information
In addition to the formal literature searches and presentations,
evidence on adverse events following pertussis or rubella
vaccination was received from the following sources or
individuals:
Bell of Atri, Inc., College Park, Maryland. Letter from J.
Anthony Morris to Dean A. Blumberg, October 19, 1990; and Comments
on published material.
Center for Empirical Medicine, Washington, D.C. Contribution to
the discussion of a connection between childhood vaccinations and
neurologic disease.
Centers for Disease Control. Selected reported adverse events
following immunization, U.S., 1978-1990; and Case reports from the
Monitoring System for Adverse Events Following Immunization
(MSAEFI).
Chronic Rubella Viremia Support, Cataldo, Idaho. Newsletters and
informational material.
Determined Parents to Stop Hurting Our Tots, Beaver Falls,
Wisconsin. Case reports and published material.
Dissatisfied Parents Together, Vienna, Virginia. Comments on
proposed vaccine information materials on
diphtheria-tetanus-pertussis vaccine (letters and attachments to
the Centers for Disease Control).
Mr. and Mrs. Donny Epps, Athens, Georgia. Case report.
Mark R. Geier, Silver Spring, Maryland. Articles and unpublished
material on pertussis vaccine.
Joanne M. Hatem, York Gastroenterology, York, Pennsylvania.
Review of prelicensing studies of RA 27/3 vaccine.
Institute of Medicine. Background materials and presentations
for a Workshop on the National Childhood Encephalopathy Study,
November 1989.
National Vaccine Information Center, Vienna, Virginia. Case
reports submitted to Dissatisfied Parents Together between May 1990
and October 1990; and Newsletters dated Spring 1990, November 1990,
and March 1991.
Study of Neurologic Illness in Children, Seattle, Washington.
Case reports provided by James Gale.
Dirk Teuwin, SmithKline Biologicals, Rixensart, Belgium
Aubrey Tingle, University of British Columbia, Vancouver
Jeanette Wilkins, University of Southern California, Los
Angeles. Bibliographic material on pertussis vaccine.
Arthur Zahalsky, Southern Illinois University, Edwardsville.
Unpublished papers on pertussis toxin and pertussis vaccine.
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Review of Interim Bibliography
Midway through the project (December 1990), an interim
bibliography of more than 1,000 citations bearing on the topics
under examination by the committee was circulated to 17 individuals
representing a range of views on the topic of adverse events
following pertussis and rubella vaccination. These individuals were
asked to identify the pertinent sources of information missing from
the bibliography to ensure that no important information was
overlooked by the committee.
ABSTRACTION OF DATA FROM CASE REPORTS,
CASE SERIES, AND CONTROLLED STUDIES
Rationale
The committee decided early in the project to abstract key data
from two general sources: (1) case series and case reports
published in the peer-reviewed literature or obtained from parents
or other sources and (2) controlled studies in humans published in
the peer-reviewed literature. Abstracted data were used to evaluate
both the extent and completeness of current case series, case
report, and controlled study data. In addition, controlled study
data were used to characterize the quality of individual controlled
studies, to assess the feasibility of pooling study data for
meta-analysis, and to identify gaps in knowledge.
Procedures for Abstraction and
Adjudication of Study Data
Case series and case reports were identified from a variety of
sources: the published literature; parents or affected individuals;
organizations such as Dissatisfied Parents Together and its
National Vaccine Information Center; reports from the Centers for
Disease Control's Monitoring System for Adverse Events Following
Immunization (MSAEFI); and reports from the Study of Neurologic
Illness in Children (SONIC), sponsored by the Centers for Disease
Control at the University of Washington in Seattle. The form used
for abstracting case reports and case series was developed by the
committee and was pretested by Bennett Shaywitz of the committee.
Case series and case reports were abstracted by John Bailey,
Michael Katz, or Bennett Shaywitz of the committee. (The Case
Report Review Form appears later in this appendix.)
The form used for abstracting data from reports of controlled
studies in humans was developed and pretested by Linda Cowan and
Darwin Labarthe of the committee, who also evaluated the
evidentiary base to identify appropriate studies for abstracting.
Data from each controlled study were ab-
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stracted independently by two upper-level doctoral students
under the supervision of Linda Cowan and Darwin Labarthe. Completed
pairs of questionnaires were then reviewed by Darwin Labarthe,
Linda Cowan, or Christopher Howson (project director) for
consistency of response. In the case of discordant responses, the
original article was checked and the response was adjudicated by
the reviewer. (The Controlled Study Review Form appears later in
this appendix.)
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Representative terms from entire chapter:
pertussis vaccine
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