Objective measures in randomized control trials of

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Introduction
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Chronic Inflammatory disorder
(Bateman E et al. Global Initiave for Asthma 2009)
300 million people affected worldwide
(Bateman E et al. Global Initiave for Asthma 2009)
Its prevalence has been increasing
(Braman S. The Global Burden of Asthma 2006)
Inflammatory reaction
 Causes
wheezing,
breathlessness,
tightness and coughing
chest
(Bateman E et al. Global Initiave for Asthma 2009)
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Asthma is a heterogeneous condition
(Reddel H et al. American Thoracic Society Documents 2008)
There is still no clear definition of asthma
control: the criteria used in its evaluation
varies from study to study (Reddel H et al. American Thoracic
Society Documents 2008)
American Thoracic Society – 2006
 List of outcome measures:
- Baseline
- During the study
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Asthma cannot be cured but it can be efficiently
treated (Bateman E et al. Global Initiave for Asthma 2009)
○ Inhaled medication – deliver drugs directly to the
source of the problem
 Fewer side effects
Drug groups :
 Controllers: avoid inflammatory reactions
 Relievers: alleviate the effects of an asthma
exacerbation
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Controllers: Inhaled corticosteroids (ICSs):
 Beclomethasone
dipropionate, budesonide,
ciclesonide, flunisolide, fluticasone propionate,
mometasone
furoate
and
triamcinolone
acetonide
Relievers: Beta-2 Agonists:
 Short-acting beta-2 Agonists:
○ Albuterol/salbutamol, fenoterol, levalbuterol,
metaproterenol, pirbuterol and terbutaline.
(Bateman E et al. Global Initiave for Asthma 2009)
 Long-acting beta-2 agonists: used daily in
combination with ICSs to improve lung function
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On
both
baseline
characteristics
and
assessment of the treatment effect on current
clinical control:




Symptom free days
Relievers use
Composite scores (He Q. Ofqual 2009)
Quality of life
(LJ Bilingham et al, Health Technology Assessment 1999)
Baseline characteristics:
 Pre-BD Fev 1 (Spirometry for health care providers)
 Pos-BD Fev 1 (Spirometry for health care providers)
A assessment of the treatment effect on current
clinical control:
 Exacerbation within last 1-4 weeks
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Research question
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Are randomized controlled trials that
assess inhaled asthma therapy drugs
using the minimum outcome measures
recommended by the American Thoracic
Society both on baseline and during the
trial?
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Aims
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 Determinate
if RCTs are using the
minimum set of outcome measures
recommended
Analyze which measures are used the
most
 Understand the evolution of measures
taken

 Through time
 Before and after the ATS’ guideline (2006)
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Methods
and
Participants
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Final query

"Asthma"[Majr] AND ("Beclomethasone dipropionate"[tiab]
OR "Budesonide"[tiab] OR "Ciclesonide"[tiab] OR
"Flunisolide"[tiab] OR "Fluticasone propionate"[tiab] OR
"Mometasone furoate "[tiab] OR "Triamcinolone acetonide
"[tiab] OR "Terbutaline"[tiab] OR "Pirbuterol"[tiab] OR
"Metaproterenol"[tiab] OR "Levalbuterol"[tiab] OR
"Fenoterol"[tiab] OR "Albuterol"[tiab] OR
"salbutamol"[tiab] OR "Short-acting Beta-2 agonists"[tiab]
OR "Inhaled corticosteroids"[tiab]) AND
"Therapeutics"[Mesh] AND ("humans"[MeSH Terms] AND
Randomized Controlled Trial[ptyp] AND (English[lang])
AND ("1970/1/1"[PDAT] : "3000"[PDAT])) NOT ("Child"[All
Fields] OR "Children"[All Fields] OR "childhood"[All
Fields])
 1158
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Inclusion criteria:
It has to be a RCT;
 It has to be in english;
 It has to be pos 1970 (included);
 Study’s participants have to be adults;
 Medicine used can only be beta-2agonists and inhaled corticosteroids.

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Exclusion criteria:
Can’t include cohort studies or any kind
of article besides RCTs
 Can’t be experienced in children
 Can’t be used any medicine besides
beta-2-agonists
and
inhaled
corticosteroids

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Variables to exam

Measures taken

Citation’s number

Sponsoring by Pharmaceutical Industry
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Expected Results
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We don´t expect all articles to fulfill all
the outcome standardized measures
 Increasing of measures taken throughout
time;
 Especcially after ATS’ guideline.
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Influence of pharmaceutical industry
sponsorship
Relation with number of citations
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References
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
[1] - Bateman E, B.L., Cruz A, FitzGerald M, Haahtela T, Levy M, O'Byrne P,
Ohta K, Paggario P, Pedersen S, Soto-Quiroz M, Wong G, executive
committee. Becker A, Lemanske R, Pedersen S, Sly P, Soto-Quiroz M, Wong
G, Zar H, pediatric writting group. Pocket Guide for Asthma Management and
Prevention in Children 5 years and younger. GINA - Global Initiative for
Asthma . 2009.

[2] - Masoli M, Fabian D, Holt S, Beasley R. Global Burden of Asthma. GINA Global Initiative for Asthma . 2006.

[3] - Frampton GK, Shepherd J. Patient-reported outcomes in clinical trials of
inhaled asthma medications: systematic review and research needs. Qual Life
Res. 2010 Oct 14.

[4] - Reddel HK, Taylor DR, Bateman ED, Boulet LP, Boushey HA, Busse WW,
Casale TB, Chanez P, Enright PL, Gibson PG, de Jongste JC, Kerstjens HA,
Lazarus SC, Levy ML, O'Byrne PM, Partridge MR, Pavord ID, Sears MR, Sterk
PJ, Stoloff SW, Sullivan SD, Szefler SJ, Thomas MD, Wenzel SE. An official
American Thoracic Society/European Respiratory Society statement: asthma
control and exacerbations: standardizing endpoints for clinical asthma trials and
clinical practice. American Journal of Respiratory and Critical Care Medicine.
2009 Jul 1;180(1): 59-99
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[5] - Fromer L. Managing asthma: an evidence-based approach to optimizing
inhaled corticosteroid treatment. Department of Family Medicine, UCLA School
of Medicine (Los Angeles, USA). Souther Medical Journal. 2010 Oct; 103(10):
2-3

[6] – The Diagnosis and Treatment of Adult Asthma. Best Practice Evidencebased Guideline (Wellington, New Zealand). New Zealand Guidelines Group
(NZGG).2002 Sep. 1-3.

[7] Asthma Management Handbook. National Asthma Council Australia(South
Melbourne). 2006

[8] - He Q. Estimating the Reliability of Composite Scores. Ofqual. 2009 Dec.
10: 1.

[9] - Billingham LJ, Abrams KR, Jones DR. Methods for the analysis of qualityof-life and survival data in health technology assessment. Health Technology
Assessment (Winchester, England). 1999;3(10):1-152.

[10] - Spirometry for health care providers. Global Initiative for Chronic
Obstructive Lung Disease (GOLD). 1-2
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Workgroup
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Ana Rita Melo
Cláudia Pinto
Fernanda Alves
João Pereira
Maria Garcia
Pedro Gouveia
Ricardo Pinto
Tânia Cavaco
Tiago Valente
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