Summary
Background: Two major issues in quality of life (QOL) research include the patients’ opinion as a contributing factor in QOL-assessments, and the lack of sensitivity of QOL-assessments.
Objectives: To review results from recent research by the Dutch Mononitrate Quality Of Life (DUMQOL) Study Group relevant to these issues.
Results: Using a test-battery including Stewart’s Short Form (SF)-36 Questionnaire and the DUMQOL-50 questionnaire, the DUMQOL Study Group tested the hypothesis that the patients’ opinion might be an independent determinant of QOL and performed for that purpose a stepwise multiple regression analysis of data from 82 outpatient clinic patients with stable angina pectoris. Psychological distress was the most important contributor to QOL (beta 0.43, P<0.0001). Also, the patients’ opinion significantly contributed to QOL (beta 0.22, P= 0.032). Physical health status according to the patients’ judgment only made a borderline contribution (beta 0.19, P=0.71), while the physicians’ judgment was not associated with QOL at all (beta 0.11, P=0.87). Using an Odds ratio approach of QOL scores in 1350 outpatient clinic patients with stable angina pectoris the DUMQOL Study Group assessed the question that relative scores might provide increased precision to estimate the effects of patient characteristics on QOL data. Increased QOL difficulties were observed in New York Heart Association Angina Class (NYHA) III-IV patients, in patients with comorbidity, as well as in females and elderly patients. Odds ratios can be used in these categories to predict the benefit from treatments.
Conclusions: Recent QOL-research of the DUMQOL Study Group allows for conclusions relevant to clinical practice. QOL should be defined in a subjective rather than objective way. The patients’ opinion is an important independent contributor to QOL. The comparison of absolute QOL-scores lacks sensitivity to truly estimate QOL. The odds ratio approach of QOL scores provides increased precision to estimate QOL.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
Preview
Unable to display preview. Download preview PDF.
9. References
Frieswijk N, Buunk BP, Janssen RM, Niemeyer MG, Cleophas TJ, Zwinderman AH. Social comparison and quality of life: evaluation in patients with angina pectoris. Cardiogram 2000; 16: 26–31.
Zwinderman AH, Niemeyer MG, Kleinjans HA, Cleophas TJ. Application of item response modeling for quality of life assessments in patients with stable angina pectoris. In: Clinical Pharmacology, EDS Kuhlman J, Mrozikiewicz A, Zuckschwerd Verlag, New York, 1999, pp 48–56.
Stewart AL, Hays RD, Ware JE. The MOS short form general health survey. Med Care 1988;26:724–735.
Brazier JE, Harper R, Jones NM, O’Cathain A, Thomas KJ, Usherwood T, Westlake L, Validating the SF-36 health survey questionnaire: new outcome measure for primary care. Br Med J 1992; 305: 160–164.
Gill TM, Feinstein AR. A critical appraisal of the quality of quality-of-life measurements. J Am Med Assoc 1994; 272: 619–626.
Marquis P, Fagol C, Joire JE. Quality of life assessment in patients with angina pectoris. Eur Heart J 1995; 16: 1554–1559.
Testa MA, Simonson DC. Assessment of quality-of-life outcomes. N Engl J Med 1996; 334: 835–840.
Thompson DR, Meadows KA, Lewin RJ. Measuring quality of life in patients with coronary heart disease. Eur Heart J 1998; 19: 693–695.
Niemeyer MG, Kleinjans HA, De Ree R, Zwinderman AH, Cleophas TJ, Van der Wall EE. Comparison of multiple dose and once-daily nitrate therapy in 1350 patients with stable angina pectoris. Angiology 1997; 48: 855–863.
Ware JE, Snow KK, Kosinski M, Gandek B. SF-36 Health survey: manual and interpretation guide. Boston. The Health Institute, New England Medical Center, 1993.
Albert SM, Frank L, Mrri R, Hylandt, Apolone G, Leplége A. Defining and measuring quality of life in medicine. J Am Med Assoc 1998; 279: 429–431.
Author information
Authors and Affiliations
Rights and permissions
Copyright information
© 2002 Springer Science+Business Media Dordrecht
About this chapter
Cite this chapter
Cleophas, T.J., Zwinderman, A.H., Cleophas, T.F. (2002). Quality-of-Life Assessments in Clinical Trials. In: Statistics Applied to Clinical Trials. Springer, Dordrecht. https://doi.org/10.1007/978-94-010-0337-7_15
Download citation
DOI: https://doi.org/10.1007/978-94-010-0337-7_15
Publisher Name: Springer, Dordrecht
Print ISBN: 978-1-4020-0570-1
Online ISBN: 978-94-010-0337-7
eBook Packages: Springer Book Archive