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How representative are clinical study patients with asthma or COPD for a larger "real life" population of patients with obstructive lung disease?

Herland, K; Akselsen, JP; Skjonsberg, OH and Bjermer, Leif LU (2005) In Respiratory Medicine 99(1). p.11-19
Abstract
Evidence-based medicine is a corner stone in treatment decision making and large randomised, clinical trials are usually designed in order-to provide highly significant results. This study was conducted in order to find out to what extend a "real life" patient population with obstructive lung disease could fit into criteria commonly used in clinical research trials. As a secondary aim of the study, eve wanted to compare the OLD population recruited from GP's and specialist outpatient clinics, respectively. Eight-hundred and seventy prospective OLD patients were included. Criteria's for selecting asthma patients to a clinical trial were, absence of co-morbidity, FEV 50-85% of predicted, present or historical reversibility 12% last year,... (More)
Evidence-based medicine is a corner stone in treatment decision making and large randomised, clinical trials are usually designed in order-to provide highly significant results. This study was conducted in order to find out to what extend a "real life" patient population with obstructive lung disease could fit into criteria commonly used in clinical research trials. As a secondary aim of the study, eve wanted to compare the OLD population recruited from GP's and specialist outpatient clinics, respectively. Eight-hundred and seventy prospective OLD patients were included. Criteria's for selecting asthma patients to a clinical trial were, absence of co-morbidity, FEV 50-85% of predicted, present or historical reversibility 12% last year, non-smoke or if ex-smoke a smoke burden less then 10 pack years. Only 5.4% of the study asthma patients met with these criteria. Additional criteria's as being symptomatic and regular use of inhaled corticosteroids reduced the numbers of eligible asthma patients to 3.3% representing 1.3% of the entire population. The same procedure was applied for the COPD patients, requesting a FEV1 < 70% of predicted normal, significant smoke history (> 15 pack years) and absence of atopy. This selected 17% of the COPD population, representing 7% of the entire population. We conclude that "evidence based" treatment decisions for OLD are based on studies which include a very small and highly selected fraction of this patient population. It is questionable whether such data can extrapolated to a larger, "real life" population of patients with obstructive lung disease. Moreover, eve found surprisingly minor differences between the Specialist and GP populations. (Less)
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author
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
clinical trial, feasibility, asthma, COPD, inclusion criterias
in
Respiratory Medicine
volume
99
issue
1
pages
11 - 19
publisher
Elsevier
external identifiers
  • pmid:15672843
  • wos:000226311100002
  • scopus:10944232455
ISSN
1532-3064
DOI
10.1016/j.rmed.2004.03.026
language
English
LU publication?
yes
id
d9434001-d80e-4df5-9589-70a1712a28df (old id 255541)
date added to LUP
2007-08-14 14:09:48
date last changed
2017-11-12 03:59:22
@article{d9434001-d80e-4df5-9589-70a1712a28df,
  abstract     = {Evidence-based medicine is a corner stone in treatment decision making and large randomised, clinical trials are usually designed in order-to provide highly significant results. This study was conducted in order to find out to what extend a "real life" patient population with obstructive lung disease could fit into criteria commonly used in clinical research trials. As a secondary aim of the study, eve wanted to compare the OLD population recruited from GP's and specialist outpatient clinics, respectively. Eight-hundred and seventy prospective OLD patients were included. Criteria's for selecting asthma patients to a clinical trial were, absence of co-morbidity, FEV 50-85% of predicted, present or historical reversibility 12% last year, non-smoke or if ex-smoke a smoke burden less then 10 pack years. Only 5.4% of the study asthma patients met with these criteria. Additional criteria's as being symptomatic and regular use of inhaled corticosteroids reduced the numbers of eligible asthma patients to 3.3% representing 1.3% of the entire population. The same procedure was applied for the COPD patients, requesting a FEV1 &lt; 70% of predicted normal, significant smoke history (&gt; 15 pack years) and absence of atopy. This selected 17% of the COPD population, representing 7% of the entire population. We conclude that "evidence based" treatment decisions for OLD are based on studies which include a very small and highly selected fraction of this patient population. It is questionable whether such data can extrapolated to a larger, "real life" population of patients with obstructive lung disease. Moreover, eve found surprisingly minor differences between the Specialist and GP populations.},
  author       = {Herland, K and Akselsen, JP and Skjonsberg, OH and Bjermer, Leif},
  issn         = {1532-3064},
  keyword      = {clinical trial,feasibility,asthma,COPD,inclusion criterias},
  language     = {eng},
  number       = {1},
  pages        = {11--19},
  publisher    = {Elsevier},
  series       = {Respiratory Medicine},
  title        = {How representative are clinical study patients with asthma or COPD for a larger "real life" population of patients with obstructive lung disease?},
  url          = {http://dx.doi.org/10.1016/j.rmed.2004.03.026},
  volume       = {99},
  year         = {2005},
}