Introdução à MedicinaTurma 12

Authors: Melo AR, Pinto C, Alves FC, Pereira JP, Garcia M, Gouveia P, Pinto RJ, Cavaco TC, Valente TAuthor’s contact: intromed1011turma12@gmail.comAdviser: Professor Tiago Jacinto

IntroductionIntroduction

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There is still no clear definition of asthma control: the criteria used in its evaluation the criteria used in its evaluation varies from study to study 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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Both on baseline characteristics baseline characteristics and on the assessment of the treatment effect on current assessment of the treatment effect on current clinical controlclinical control: Symptom free daysRelievers useComposite scores (He Q. Ofqual 2009)

Quality of life (LJ Bilingham et al, Health Technology Assessment 1999)

Baseline characteristicsBaseline characteristics: Pre-BD Fev 1 (Spirometry for health care providers)Pos-BD Fev 1 (Spirometry for health care providers)

Assessment of the treatment effect on current Assessment of the treatment effect on current clinical controlclinical control:Exacerbation within last 1-4 weeks

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Research questionResearch question

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MAIN RESEARCH QUESTION - 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?

Is there any relation between pharmaceutical industry sponsorship and outcome measures taken?

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AimsAims

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Determine 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’s guideline (2006).

Determine if there is a relation between pharmaceutical industry sponsorship and outcome measures taken.

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Methods and ParticipantsMethods and Participants

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Data collection

"Asthma” - clinicaltrials.gov databaseInterventional studies phase IIIClosed studies with results12 years and older participants

○ 61 articles

"Asthma” - clinicaltrialsregister.eu databaseInterventional studies phase IIICompleted studies12 years and older participants

○ 81 articles

Total of 142 articles foundTurma 12

Eligibility criteria:

Randomized controlled trial phase III; Asthma; English language; Pos 1980 (included); 12 years and older; Medication: beta-2-agonists and inhaled

corticosteroids.

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Flowchart

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n=61 n=81

Inclusions

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17 trials included5 from clinicaltrials.gov12 from clinicaltrialsregister.eu

Variables to exam

Measures taken

Sponsoring by pharmaceutical industry

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ResultsResults

• Articles’ Graphs

-Number of Recommended Outcome Measures used by each article according to time and database it was searched

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American DatabaseEuropean Database

n =17

The line represent the Cut-off

-Recommended Outcome Measures’ Frequency in articles included

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n=11

• Pharmaceutical Industry Sponsorship

There is not enough data to analyse the influence of pharmaceutical industry.Only 2 in 17 articles were not sponsored

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Statistical Analysis

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Variable examined: number of recommended outcome measures used

T-test to compare databases○ p= 0,002 (µ=5 , µ=2)

T-test to compare before/after 2007○ p= 0,018 (µ=5 , µ=2)

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Discussion and ConclusionDiscussion and Conclusion

Discussion and Conclusion

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There is no evidence that the number of recommended outcome measures taken by articles has increased after 2007.

It seems that the ATS guideline is not being followed

No conclusions concerning the influence of pharmaceutical industry sponsoring

ReferencesReferences

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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] - 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

  [5] – The Diagnosis and Treatment of Adult Asthma. Best Practice Evidence-

based Guideline (Wellington, New Zealand). New Zealand Guidelines Group (NZGG).2002 Sep. 1-3.

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[6] - Asthma Management Handbook. National Asthma Council Australia(South Melbourne). 2006

[7] - 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

  [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 quality-of-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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