University
Medical Centre Utrecht (UMCU) , Department of General Practice , PO BOX 80045 ,
3508 TA Utrecht
Study on
Prevention of
Influenza in
Copd
and
Asthma
|
|
Title
SPICA (Study on Prevention of Influenza in COPD and Asthma)
Subtitle
Effectiveness and costs of influenza vaccination in COPD and
asthma patients aged 18 to 64 years: a nested case-control study
Proposal Abstract
Background
According to Dutch immunisation guidelines, all asthma
and COPD patients are indicated for influenza vaccination, regardless of age.
Approximately three-quarter of these patients is between 18 and 64 years of age
and the majority can be classified as asthmatics. In current practice less than
50% of these patients are being immunised. Future improvement of immunisation
coverage will require much effort by GPs. Two small-scale studies in selected
adult asthmatics suggested a relatively small role for influenza virusses in
causing exacerbations. As no information on clinical effectiveness of influenza
vaccination in this patient group is currently available and additional annual
costs associated with both the organisation and the vaccination itself exceed
several million guilders, (cost-) effectiveness studies in the Dutch setting are
urgently needed.
Aim
We aim to assess the clinical effectiveness and associated
costs of a general practice-based influenza immunisation program in asthma and
COPD patients aged 18-64 years.
Methods
As an experiment is regarded unethical and not feasible
due to low attack rates of complications, a nested case-control study is being
proposed. In 100 computerised general practices, all asthma/COPD patients are
tracked on the basis of relevant tags, coded diagnoses and medications by using
a standard search module. Patients classified as asthma or COPD patient
according to the consensus statements of the European Respiratory Society (ERS)
and the National Heart, Lung and Blood Institute (NHLBI), have an indication for
vaccination and will be enrolled in the study cohort. Patients with heart
failure or who do not master the Dutch language will not be admitted. All
patients will be invited for vaccination by their GP in a standardised way.
Cases are asthma/COPD patients who develop at least one of the following
non-fatal complications, verified by clinical tests, during the influenza
period: severe asthma/COPD exacerbation, pneumonia, congestive heart failure and
myocardial infarction. For every case, four age-matched control patients (cohort
members without such a complication at that time) will be selected at random.
Because of yearly changes in impact of influenza, cohort members will be
followed during two consecutive seasons. Data collected include: (1) date of
vaccination, (2) complications, (3) prognostic indicators for severity of
illness and extraneous interventions that may act as confounders: e.g. age, lung
function, medication use, treatment by a pulmonologist, comorbidity, smoking
behaviour, GP visits in preceding 12 months, gender, health insurance, previous
infectious diseases, (4) nose/throat swabs will be taken and frozen, so that the
presence of the influenza virus can be detected by PCR at the end of the study
period in a sample of cases and matched controls, (5) economical data, e.g.
production loss, medical treatment, hospitalisation and intensive care.
Analysis
Clinical vaccine effectiveness of the immunisation
program in both seasons is assessed after adjustment for confounding prognostic
indicators using multivariable conditional logistic regression. In the
economical analysis (in)direct savings due to reduced medication use, hospital
stay or intensive care, and reduced production loss will be related to
(in)direct immunisation costs.
Study period
April 1998 till december 2000.
Research Program
Infectious disease in General Practice,
part of
UMCU Graduate
School for Infection and Immunity
Participating Institutes
University Medical Centre Utrecht
(UMCU)
Department of General Practice
Julius Centre for Patient Oriented
Research
Division of Pulmonary Disease
Division of Virology
Projectleaders
A.W. Hoes, PhD, professor of Clinical Epidemiology in
General Practice
Th.J.M. Verheij, PhD, professor of General Practice
PhD student
E. Hak, MSc, epidemiologist
e-mail: E.Hak@med.uu.nl
Research Committee
E. Buskens, PhD, MTA-expert
G.A. van Essen, PhD,
general practitioner
J-W.J. Lammers, PhD, professor of Pulmonary
Disease
A.M. van Loon, PhD, virologist
A.P.E. Sachs, PhD, general
practitioner
W.A.B. Stalman, PhD, general practitioner
SPICA datamanagement
Ir. F.C. Leffers, IT specialist
Mrs. D. Balk,
secretary
Mrs. M. van den Haak, secretary
telephone: +31 30 253
8191/8195
fascimile:+31 30 253 8757
e-mail:SPICA@med.uu.nl
Funding
Asthma Foundation, grant
number 97-51
telephone: +31 33 4941814
Current Status
Study status: currently underway
Expected completion
date: recruitment first season completed 1 april 1999
Expected publication
date: first publications are to be expected autumn 1999
Further Information
For further details on this multicenter project
please contact:
SPICA@med.uu.nl
Related publications
Sachs APE, Van der Waay D, Groenier KH, Koeter GH,
Schiphuis J. Oropharyngeal flora in asthma and in chronic obstructive pulmonary
disease. Indigenous oropharyngeal microorganisms in outpatients with asthma and
COPD. Am Rev Respir Dis 1993;148:1302-7
Hak E, Essen GA
van, Stalman W, Stoutenbeek Y, Kuijvenhoven MM, Melker RA de. Een griepmodule in
een huisartsinformatiesysteem: Een onderzoek naar de doeltreffendheid bij
selectie, oproep en monitoring van risicopatiënten. Huisarts Wet
1996;39:449-52
Essen GA van, Kuyvenhoven MM, Melker RA de.
Implementing Dutch College of General Practitioners (NHG) guidelines for
influenza vaccination. Br J Gen Pract 1997;47:25-9
Hak E,
Hermens RPMG, Essen GA van, Kuijvenhoven MM, Melker RA de. Population-based
prevention of influenza in Dutch general practice. Br J Gen Pract
1997;47:363-6
Hak E, Essen GA van, Buskens E, et al. Is immunising
all patients with chronic lung disease in the community against influenza cost
effective? J Epidemiol Community Health 1998;52:120-5
Hak
E, Essen GA van, Stalman W, RA de Melker. Improving influenza vaccination
coverage among high-risk patients: the role of computerised medical records.
Fam Pract 1998;15:138-43
Hak E, Essen GA van, Grobbee DE,
Verheij ThJM. Effectiveness of pneumococcal vaccine [letter]. Lancet
1998;351:1283
Hak E Grobbee DE, Verheij Th. Kosten-effectiviteit
van pneumokokkenvaccinatie van ouderen [reactie]. Ned Tijdschr Geneeskd
1998;142:201-2
Hak E, Essen GA van, Grobbee DE, Buskens E,
Hoepelman IM, Verheij ThJM. Hoe doelmatig is pneumokokkenvaccinatie in de
huisartspraktijk? Een literatuuronderzoek. Huisarts Wet
1998;41:470-5
Links
Centers for Disease Control and Prevention: Influenza Prevention
and Control
http://www.cdc.gov/ncidod/diseases/flu/fluvirus.htm
NEW Cursus Literatuuronderzoek op Internet NEW
http://www.med.uu.nl/HAG/Cursus/literatuuronderzoek.htm
Eijkman-Winkler Institute for Microbiology, Infectious Diseases and
Inflammation, University Hospital Utrecht
http://www.accu.nl/ewi-enare/
Last modified: 8 february 1999 / WebMaster@med.uu.nl
