What are minimal important changes for asthma measures in a clinical trial?

European Respiratory Journal

Volumn 14, Issue 1, 1999, Pages 23-27

  Santanello, N C ^a,c   Zhang, J ^a   Seidenberg, B ^a   Reiss, T F ^a   Barber, B L ^b  

^a MERCK RESEARCH LABORATORIES   (United States)

^b ELI LILLY AND COMPANY   (United States)

^c NONE   (United States)

Author keywords

Asthma; Epidemiology; Methods; Questionnaires

Indexed keywords

BETA ADRENERGIC RECEPTOR STIMULATING AGENT; MONTELUKAST;

ADULT; ARTICLE; ASTHMA; CLINICAL FEATURE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DISEASE COURSE; DISEASE SEVERITY; DRUG UTILIZATION; FEMALE; FORCED EXPIRATORY VOLUME; HUMAN; MAJOR CLINICAL STUDY; MALE; PEAK EXPIRATORY FLOW; PERCEPTION; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL;

ACETATES; ADMINISTRATION, INHALATION; ADOLESCENT; ADRENERGIC BETA-AGONISTS; ADULT; AGE FACTORS; AGED; ASTHMA; CIRCADIAN RHYTHM; DOUBLE-BLIND METHOD; EPIDEMIOLOGIC MEASUREMENTS; FEMALE; HUMANS; LEUKOTRIENE ANTAGONISTS; LUNG; MALE; MIDDLE AGED; QUINOLINES; RESPIRATORY FUNCTION TESTS; SEVERITY OF ILLNESS INDEX; SEX FACTORS; SINGLE-BLIND METHOD;

EID: 0032851785     PISSN: 09031936     EISSN: None     Source Type: Journal    
DOI: 10.1034/j.1399-3003.1999.14a06.x     Document Type: Article

References (15)

1. Busse WW, Reed CE. Asthma: definition and pathogenesis. In: Middleton E, Reed CE, Ellis EF, Adkinson HF, Yunginger JW, eds. Allergy: Principles and Practice. 3rd Edn. St. Louis, CV Mosby 1988; p. 969.
2. Santanello NC, Barber BL, Friedman B, Reiss TF, Zhang J. Measurement characteristics of two asthma symptom diaries validated in two separate clinical trials. Eur Respir J 1997; 10: 646-651.
3. Jaeschke R, Singer J, Guyatt GH. Measurement of health status. Control Clin Trials 1989; 10: 407-415.
4. Juniper EF, Guyatt GH, Willan A, Griffith LE. Determining a minimal important change in a disease-specific quality of life questionnaire. J Clin Epidemiol 1994; 47: 81-87.
5. Redelmeier DA, Guyatt GH, Goldstein RS. Assessing the minimal important difference in symptoms: a comparison of two techniques. J Clin Epidemiol 1996; 49: 1215-1219.
6. Noonan MJ, Chervinsky P, Brandon M, et al. Montelukast, a potent leukotriene receptor antagonist, causes dose-related improvements in chronic asthma. Eur Respir J 1998; 11: 1232-1239.
7. Spitzer RL, Cohen J, Fleiss JL, Endicott J. Quantification of agreement in psychiatric diagnosis. Arch Gen Psychiatry 1967; 17: 83-87.
8. Connolly MJ, Crowley JJ, Charan NB, Nielson CP, Vestal RE. Reduced subjective awareness of bronchoconstriction provoked by methacholine in elderly asthmatic and normal subjects as measured on a simple awareness scale. Thorax 1992; 47: 410-413.
9. Rubinfeld AR, Pain MC. Conscious perception of bronchospasm as a protective phenomenon in asthma. Chest 1977; 72: 154-158.
10. Rubinfeld AR, Pain MC. Perception of asthma. Lancet 1976; i: 882-884.
11. Lydick E, Epstein RS. Interpretation of quality of life changes. Qual Life Res 1993; 2: 221-226.
12. Juniper EF. Quality of life questionnaires: does statistically significant=clinically important? J Allergy Clin Immunol 1998; 102: 16-17.
13. Guyatt GH, Juniper EF, Walter SD, Griffith LE, Goldstein RS. Interpreting treatment effects in randomized trials. BMJ 1998; 316: 690-693.
14. Norman GR, Stratford P, Regehr G. Methodological problems in the retrospective computation of responsiveness to change: the lesson of Cronbach. J Clin Epidemiol 1997; 50: 869-879.
15. Barber BL, Santanello NC, Epstein RS. Impact of the global on patient perceivable change in an asthma specific QOL questionnaire. Qual Life Res 1996; 5: 117-122.