With the need to measure the effect of treatments on the quality of life of patients in Phase II/III clinical trials, the objectives of the protocol need to be defined operationally in clinically relevant terms; the measure used must be appropriate to the protocol and population including an appropriate range; duplicate information should not be collected; and direct, less expensive measures could be used, often more effectively.
KarnofskyDAAblemanWHCraverLFThe use of nitrogen mustards in the palliative treatment of carcinoma. Cancer. 1948;1: 634–656.
2.
Criteria Committee of the New York Heart Association, Inc.Nomenclature and criteria for diagnosis. In: Diseases of the Heart and Blood Vessels. 6th Ed.Boston MA: Little, Brown; 1964:110–114.
3.
ShoemakerDBurkeGDorrATempleR.FriedmanM. A regulatory perspective. In SpilkerB, ed. Quality of Life Assessment in Clinical Trials. New York: Raven Press, Ltd; 1990;16:193–201.
4.
JohnsonJ. FDA perspective on quality of life measurement instruments in cancer drug clinical trials. Presentation at the American Association of Pharmaceutical Scientists Meeting, Atlanta, GA, Oct. 23, 1989.
5.
WareJSherbourneCD. The MOS 36-item short form health survey (SF-36). Med Care. 1992;30: 6.
6.
Minnesota Multiphasic Personality Inventory. Minneapolis: University of Minnesota: 1966.
7.
Hutchinson TA, Boyd NF, Feinstein AR.Scientific problems in clinical scales, as demonstrated in the Karnofsky Index of Performance Status. J Chron Dis. 1979;32:661–666.
8.
MorVLaliberteLMorrisJNThe Karnofsky Performance Status Scale: An examination of its reliability and validity in a research setting. Cancer. 1984;53: 2002–2007.
9.
SchipperHClinchJMcMurrayALevittM. Measuring the quality of life of cancer patients: The Functional Living Index—Cancer. Development and validation. J Clin Oncology. 1984;2: 472–483.
10.
GanzPAHaskellCMFiglinRAEstimating the quality of life in a clinical trial of patients with metastatic lung cancer using the Karnofsky Performance Status and the Functional Living Index—Cancer. Cancer. 1988;61: 849–856.
11.
JetteAMDaviesARClearyPDThe Functional Status Questionnaire: Reliability and validity when used in primary care. J Gen Int Med.1986;1: 143–149.
12.
GoldmanLHashimotoBCookFLoscalzoA. Comparative reproducibility and validity of systems for assessing cardiovascular functional class: Advantages of a new Specific Activity Scale. Circulation. 1981;64: 1227–1234.
13.
HlatkyMABoineauREHigginbothamMA brief self-administered questionnaire to determine functional capacity (the Duke Activity Status Index). Am J Cardiology. 1989;64: 651–654.
14.
KnausWDraperEWagnerDAPACHE II: A severity of disease classification system. Critical Care Med.1985;13: 818.
15.
GelberRDGoldhirschA. A new endpoint for the assessment of adjuvant therapy in postmenopausal women with operable breast cancer. J Clin Oncology. 1986;4: 1772–1779.
16.
BergnerMBobbittRAPollardWE. Sickness Impact Profile: Validation of a health status measure. Med Care. 1976;14: 57–61.
17.
StewartALHaysRDWareJE. The MOS short form general health survey: Reliability and validity in a patient population. Med Care. 1988;26: 724–735.
18.
HuntSMcKennaSPMcEwenJWilliamsJPappE. The Nottingham Health Profile: Subjective health status and medical consultations. Soc Science Med.1981;15A: 221–229.