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Vol. 38. Issue 12.
Pages 574-579 (December 2002)
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Vol. 38. Issue 12.
Pages 574-579 (December 2002)
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Calidad de los ensayos clínicos publicados en España sobre el asma: comparación con los ensayos clínicos publicados en revistas anglosajonas
Quality of clinical trials published in Spain on asthma in comparison to trials in English language journals
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D. Quiñonesa, J. Llorcaa,
Corresponding author
llorcaj@unican.es

Correspondencia: Medicina Preventiva y Salud Pública. Facultad de Medicina. Avda. Cardenal Herrera Oria, s/n. 39011 Santander. España
, D. Prieto-Salcedaa, M. Delgado-Rodrígueza,b
a Medicina Preventiva y Salud Pública. Facultad de Medicina. Universidad de Cantabria. Santander. España
b Medicina Preventiva y Salud Pública. Universidad de Jaén. España
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Objetivos

Evaluar la calidad de los ensayos clínicos sobre asma publicados en revistas españolas y compararla con los publicados en revistas anglosajonas.

Método

Los ensayos clínicos se obtuvieron por búsqueda en Medline e Índice Médico Español, completando con búsqueda manual a partir de los artículos previamente seleccionados. La calidad se evaluó mediante la escala propuesta por Detsky et al (J Clin Epidemiol 1992;45:255-65).

Resultados

Los artículos publicados en revistas españolas tuvieron menor calidad media que los aparecidos en otras revistas europeas o norteamericanas. Los ensayos publicados en España detallaban con menos frecuencia algunos aspectos metodológicos, incluyendo la aprobación del estudio por un comité de ética, la descripción del método de aleatorización o del flujo de pacientes y el enmascaramiento. Dentro de los ensayos publicados en España, los que tenían autor extranjero tuvieron menor calidad media.

Conclusión

Los ensayos clínicos publicados en España sobre el tratamiento del asma son de menor calidad que los publicados en revistas anglosajonas. Los editores deberían considerar el uso de listas de marcas en el proceso de revisión por pares de los ensayos clínicos para aumentar los estándares de calidad de los trabajos publicados.

Palabras clave:
Asma
Ensayo clínico controlado
Método epidemiológico
Objectives

To evaluate the quality of clinical trials on asthma published in Spanish journals in comparison with those published in European or North American English-language journals.

Method

Clinical trials were identified by searching MEDLINE and the Spanish Medical Index (Índice Médico Español), and by manual searches for trials mentioned in the bibliographies of the previously identified trials. Quality was assessed by the method proposed by Detsky and colleagues in their 1992 article in Journal of Clinical Epidemiology.

Results

The articles published in Spanish journals had lower mean quality scores than those in European or North American English-language journals. Trials published in Spain were less likely to give certain details of methodology, including ethics committee approval, details of randomization or patient enrollment and blinding. Among trials published in Spain, those with non-Spanish authors had lower mean quality scores.

Conclusions

Clinical trials published in Spain on asthma treatments are of poorer quality than those published in English-language journals. Editors should consider using clinical trial quality checklists during the peer review process to raise the standards for published articles.

Keywords:
Asthma
Controlled clinical trial
Epidemiological methodology
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Bibliografía
[1.]
Centers for Disease Control and Prevention.
Asthma mortality – Illinois: 1979-1994.
Morb Mortal Wkly Rep, 47 (1998), pp. 522-525
[2.]
C.K. Lai, J.K. Chan, A. Chan, G. Wong, A. Ho, D. Choy, et al.
Comparison of the ISAAC video questionnaire (AVQ3.0) with the ISAAC written questionnaire for estimating asthma associated with bronchial hyperreactivity.
Clin Exp Allergy, 27 (1997), pp. 540-545
[3.]
J.K. Peat, B.G. Toelle, E.J. Gray, M.M. Haby, E. Belousova, C.M. Mellis, et al.
Prevalence and severity of childhood asthma and allergic sensitisation in seven climatic regions of New South Wales.
Med J Aust, 163 (1995), pp. 22-26
[4.]
A.H. Rimpelÿa, B. Savonius, M.K. Rimpelÿa, T. Haahtela.
Asthma and allergic rhinitis among Finnish adolescents in 1977-1991.
Scand J Soc Med, 23 (1995), pp. 60-65
[5.]
D.P. Strachan, H.R. Anderson, E.S. Limb, A. O'Neill, N. Wells.
A national survey of asthma prevalence, severity and treatment in Great Britain.
Arch Dis Child, 70 (1994), pp. 174-178
[6.]
D. Charpin, C. Raherison, H. Dutan, A. Taytard.
Epidemiologie des maladies allergiques respiratoires: donées actuelles.
Rev Mal Respir, 17 (2000), pp. 139-158
[7.]
European Community Respiratory Health Survey.
Variation in the prevalence of respiratory symptoms, self-reported asthma attacks, and use of asthma medication in the European Community Respiratory Health Survey (ECHRS).
Eur Respir J, 9 (1996), pp. 687-695
[8.]
Gabinete de Estudios Sociológicos Bernard Krief.
Programa Zyterigon- Data: libro blanco. La alergia en la práctica diaria del médico de asistencia primaria y en la farmacia.
Patologías alérgicas de mayor alcance social,
[9.]
C.W. Burt, D.E. Knapp.
Ambulatory care visits for asthma: United States, 1993-1994.
Advanced Data Report, 27 (1996), pp. 1
[10.]
J.A. Ojeda Casas.
Asma infantil: presente y futuro.
Rev Esp Alergol Inmunol Clin, 14 (1999), pp. 179-182
[11.]
W.H.W. Inman, A.M. Adelstein.
Rise and fall of asthma mortality in England and Wales in relation to use of pressurised aerosols.
Lancet, 2 (1969), pp. 280-285
[12.]
F.E. Speizer, R. Doll, P. Heaf, L.B. Strang.
Investigation into use of drugs preceding death from asthma.
cBMJ, 1 (1968), pp. 339-343
[13.]
British Thoracic Association.
Death from asthma in two regions of England.
Bmj, 285 (1982), pp. 1251-1255
[14.]
R.T. Jackson, R. Beaglehole, H.H. Rea, D.F. Sutherland.
Mortality from asthma: a new epidemic in New Zealand.
Bmj, 285 (1982), pp. 771-774
[15.]
H.H. Rea, R. Scragg, R. Jackson, R. Beaglehole, J. Fenwick, D.C. Sutherland.
A case-control study of deaths from asthma.
Thorax, 41 (1986), pp. 833-839
[16.]
D.A. Campbell, G. McLennan, J.R. Coates, P.A. Frith, P.A. Gluyas, K.M. Latimer, et al.
A comparison of asthma deaths and near fatal asthma attacks in South Australia.
Eur Respir J, 7 (1994), pp. 490-497
[17.]
A. De Diego Damiá.
Nuevos fármacos en el tratamiento del asma.
Arch Bronconeumol, 32 (1996), pp. 357-365
[18.]
C. Begg, M.K. Cho, S. Eastwood, R. Horton, D. Moher, I. Olkin, et al.
Improving the quality of reporting of randomized controlled trials. The CONSORT Statement.
Jama, 276 (1996), pp. 637-640
[19.]
T.C. Chalmers, J.r. Smith H, B. Balckburn, B. Silverman.
A method for assessing the quality of a randomized control trial.
Control Clin Trials, 2 (1981), pp. 31-49
[20.]
M.K. Cho, L.A. Bero.
Instruments for assessing the quality of drug studies published in the Medical Literature.
Jama, 272 (1994), pp. 101-105
[21.]
R. DerSimonian, L.J. Charette, B. McPeek, F. Mosteller.
Reporting on methods in clinical trials.
N Engl J Med, 306 (1982), pp. 1332-1337
[22.]
A.S. Detsky, C.D. Naylor, K. O'Rourke, A.J. McGeer, K.A. L'Abbé.
Incorporating variations in the quality of individual randomized trials into meta-analysis.
J Clin Epidemiol, 45 (1992), pp. 255-265
[23.]
R.W. Evans, A.V. Pollock.
A score system for evaluating random control clinical trials of prophylaxis of abdominal surgical wound infections.
Br J Surg, 72 (1985), pp. 256-260
[24.]
F.G.R. Fowkes, P.M. Fulton.
Critical appraisal of published research: introductory guidelines.
Bmj, 302 (1991), pp. 1136-1140
[25.]
F.J. García López.
Impacto de la normativa legal en la calidad de los ensayos clínicos realizados en España.
Med Clin (Barc), 100 (1993), pp. 770-777
[26.]
A.R. Jadad, R.A. Moore, D. Carroll, C. Jenkinson, D.J. Reynolds, D.J. Gavaghan, et al.
Assessing the quality of reports or randomized clinical trials: is blinding necessary?.
Control Clin Trials, 17 (1996), pp. 1-12
[27.]
K. Linde, N. Clausius, G. Ramirez, D. Melchart, F. Eitel, L.V. Hedges, et al.
Are the clinical effects of homoeopathy placebo effects? A meta-analysis of placebo-controlled trials.
Lancet, 350 (1997), pp. 834-843
[28.]
J.A. Sacristán, J. Soto, I. Galende.
Evaluación crítica de ensayos clínicos.
Med Clin (Barc), 100 (1993), pp. 780-787
[29.]
The Standards of Reporting Trials Group.
A proposal for structured reporting of randomized controlled trials.
Jama, 272 (1994), pp. 1926-1932
[30.]
D. Moher, P. Fortin, A.R. Jadad, P. Jüni, T. Klassen, J. Le Lorier, et al.
Completeness of reporting of trials published in languages other than English: implications for conduct and reporting of systematic reviews.
Lancet, 347 (1996), pp. 363-366
[31.]
L.L. Kjaergard, D. Nikolova, C. Gluud.
Randomized clinical trials in Hepatology: predictors of quality.
Hepatology, 30 (1999), pp. 1134-1138
Copyright © 2002. Sociedad Española de Neumología y Cirugía Torácica
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