Evolving concepts in the measurement of treatment effects

Proceedings of the American Thoracic Society

Volumn 3, Issue 3, 2006, Pages 212-217

  Leidy, Nancy Kline ^a  

^a UNITED BIOSOURCE CORPORATION   (United States)

Author keywords

Chronic obstructive pulmonary disease; Issues; Outcomes; Strategies; Study design

Indexed keywords

ACCURACY; CHRONIC OBSTRUCTIVE LUNG DISEASE; CLINICAL RESEARCH; CONCEPT ANALYSIS; CONFERENCE PAPER; ENVIRONMENTAL FACTOR; HUMAN; MEDICAL ASSESSMENT; MEDICAL INFORMATION; OUTCOME ASSESSMENT; PRODUCTIVITY; RECALL; STATISTICAL SIGNIFICANCE;

BIOMEDICAL RESEARCH; FORCED EXPIRATORY VOLUME; HEALTH STATUS INDICATORS; HUMANS; OUTCOME ASSESSMENT (HEALTH CARE); PULMONARY DISEASE, CHRONIC OBSTRUCTIVE; TREATMENT OUTCOME;

EID: 33646356973     PISSN: 15463222     EISSN: 15463222     Source Type: Journal    
DOI: 10.1513/pats.200512-128SF     Document Type: Conference Paper

References (40)

1. U.S. National Library of Medicine Fact Sheet. Available from: http://www.nlm.nih.gov/pubs/factsheets/medline.html (accessed December 12, 2005).
2. U.S. National Institutes of Health. Policy on enhancing public access to archived publications resulting from NIH-funded research. Available from: http://grants2.nih.gov/grants/guide/notice-files/NOT-OD-05-022.html (accessed December 15, 2005).
3. PhRMA Clinical Study Results Database. Available from: http://www.clinicalstudyresults.org/ (accessed December 15, 2005).
4. COPD International 2005. Available from: http://www.copd-international.com/Library/statistics.htm (accessed December 13, 2005).
5. Hurd S. The impact of COPD on lung health worldwide: epidemiology and incidence. Chest 2000;117:1S-4S.
6. Vestbo J; TORCH Study Group. The TORCH (Towards a revolution in COPD Health) survival study protocol. Eur Respir J 2004;24:206-210.
7. Hopkinson NS, Toma TP, Hansell DM, Goldstraw P, Moxham J, Geddes DM, Polkey MI. Effect of bronchoscopic lung volume reduction on dynamic hyperinflation and exercise in emphysema. Am J Respir Crit Care Med 2005;171:453-460.
8. Leidy NK. Using functional status to assess treatment outcomes. Chest 1994;106:1645-1646.
9. Hlatky MA, Boineau RE, Higginbotham MB, Lee KL, Mark DB, Califf RM, Cobb FR, Pryor DB. A brief self-administered questionnaire to determine functional capacity (the Duke Activity Status Index). Am J Cardiol 1989;64:651-654.
10. Leidy NK. Psychometric properties of the functional performance inventory in patients with chronic obstructive pulmonary disease. Nurs Res 1999;48:20-28.
11. Lareau SC, Meek PM, Roos PJ. Development and testing of the modified version of the Pulmonary Functional Status and Dyspnea Questionnaire (PFSDQ-M). Heart Lung 1998;27:159-168.
12. Kobak K, Feiger A, Lipsitz J. Interview quality and signal detection in clinical trials. Am J Psychiatry 2005;162:628.
13. Leidy NK, Revicki D, Genesté B. Recommendations for evaluating the validity of quality of life claims for labeling and promotion. Value Health 1999;2:113-127.
14. Revicki D, Osoba D, Fairclough D, Barofsky I, Berzon R, Leidy N, Rothman M. Recommendations on health-related quality of life research to support labeling and promotional claims in the United States. Qual Life Res 2000;9:887-900.
15. Shiffman S, Hufford M, Paty J. Subject experience diaries in clinical research, Part 1: The patient experience movement. Appl Clin Trials 2001;10:46-56.
16. Leidy NK, Abbott R, Fedenko K. Sensitivity and reproducibility of the dual-mode actigraph under controlled levels of activity intensity. Nurs Res 1997;46:5-11.
17. Steele BG, Holt L, Belza B, Ferris S, Lakshminaryan S, Buchner DM. Quantitating physical activity in COPD using a triaxial accelerometer. Chest 2000;117:1359-1367.
18. Schmier JK, Halpern MT. Patient recall and recall bias of health state and health status. Expert Rev Pharmacoeconomics Outcomes Res 2004;4:159-163.
19. Gutek BA. On the accuracy of retrospective attitudinal data. Public Opin Q 1987;42:390-401.
20. Baker F. The basics of item response theory, 2nd ed. College Park, MD: ERIC Clearinghouse on Assessment and Evaluation; 2001.
21. Ware J, Snow K, Kosinski M, Gandek B. SF-36 Health Survey: manual and interpretation guide. Boston: The Health Institute, New England Medical Center; 1993.
22. Stahl E, Lindberg A, Jansson SA, Ronmark E, Svensson K, Andersson F, Lofdahl CG, Lundback B. Health-related quality of life is related to COPD disease severity. Health Qual Life Outcomes 2005;3:56.
23. Jones PW, Quirk FH, Baveystock CM, Littlejohns P. A self-complete measure of health status for chronic airflow limitation: the St. George's Respiratory Questionnaire. Am Rev Respir Dis 1992;145:1321-1327.
24. Jones PW, Quirk FH, Baveystock CM. The St. George's Respiratory Questionnaire. Respir Med 1991;85(B):25-31.
25. Guyatt GH, Berman LB, Townsend M, Pugsley SO, Chambers LW. A measure of quality of life for clinical trials in chronic lung disease. Thorax 1987;42:773-778.
26. Celli BR, Cote CG, Marin JM, Casanova C, Montes de Oca M, Mendez RA, Pinto Plata V, Cabral HJ. The body-mass index, airflow obstruction, dyspnea, and exercise capacity index in chronic obstructive pulmonary disease. N Engl J Med 2004;350:1005-1012.
27. Norman GR, Sloan JA, Wyrwich KW. Interpretation of changes in health-related quality of life: the remarkable universality of half a standard deviation. Med Care 2003;41:582-592.
28. Sloan J, Symonds T, Vargas-Chanes D, Fridley B. Practical guidelines for assessing the clinical significance of health-related quality of life changes within clinical trials. Drug Inf J 2003a;37:23-31.
29. Yost KJ, Cella D, Chawla A, Holmgren E, Eton DT, Ayanian JZ, West DW. Minimally important differences were estimated for the Functional Assessment of Cancer Therapy-Colorectal (FACT-C) instrument using a combination of distribution- and anchor-based approaches. J Clin Epidemiol 2005;58:1241-1251.
30. Leidy NK, Wyrwich KW. Bridging the gap: using triangulation methodology to estimate minimal clinically important differences (MCIDs). COPD: Journal of Chronic Obstructive Pulmonary Disease 2005;2:157-165.
31. Make B, Casaburi R, Leidy NK. Interpreting results from clinical trials: understanding minimal clinically important differences in COPD outcomes. COPD: Journal of Chronic Obstructive Pulmonary Disease 2005;2:1-5.
32. Donohue J. Minimal clinically important differences in COPD lung function. COPD: Journal of Chronic Obstructive Pulmonary Disease 2005;2:111-124.
33. Wise RJ, Brown CD. Minimal clinically important differences in the six-minute walk test and the incremental shuttle walking test. COPD: Journal of Chronic Obstructive Pulmonary Disease 2005;2:125-129.
34. Casaburi R. Factors determining constant work rate exercise tolerance in COPD and their role in dictating the MCID in response to interventions. COPD: Journal of Chronic Obstructive Pulmonary Disease 2005;2:131-136.
35. Sutherland ER, Make BJ. Maximum exercise as an outcome of COPD: minimal clinically important difference. COPD: Journal of Chronic Obstructive Pulmonary Disease 2005;2:137-141.
36. Butland RJ, Pang J, Gross ER, Woodcock AA, Geddes DM. Two-, six, and 12-minute walking tests of respiratory disease. BMJ 1982;284:1607-1608.
37. Redelmeier DA, Bayoumi AM, Goldstein RS, Guyatt GH. Interpreting small differences in functional status: the six minute walk test in chronic lung disease patients. Am J Respir Crit Care Med 1997;155:1278-1282.
38. American Thoracic Society. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med 2002;166:111-117.
39. Domingo-Salvany A, Lamarca R, Ferrer M, Garcia-Aymerich J, Alonso J, Felez M, Khalaf A, Marrades RM, Monso E, Serra-Batlles J, Anto JM. Health-related quality of life and mortality in male patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med 2002;166:680-685.
40. Oga T, Nishimura K, Tsukino M, Sato S, Hajiro T. Analysis of the factors related to mortality in chronic obstructive pulmonary disease: role of exercise capacity and health status. Am J Respir Crit Care Med 2003;167:544-549.