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Responsiveness of a Single-Item Indicator Versus a Multi-Item Scale: Assessment of Emotional Well-Being in an International Adjuvant Breast Cancer Trial

HÜRNY, CHRISTOPH MD*; BERNHARD, JÜRG PHD; COATES, ALAN MD; PETERSON, HARRIET F. MS§; CASTIGLIONE-GERTSCH, MONICA MD; GELBER, RICHARD D. PHD§; RUDENSTAM, CARL-MAGNUS MD; COLLINS, JOHN MD; LINDTNER, JURIJ MD#; GOLDHIRSCH, ARON MD††; SENN, HANS-JÖRG MD‡‡

Original Article

A single-item linear analogue self-assessment scale for mood was compared with a 28-item adjective checklist for emotional well-being. To confirm its concurrent validity and responsiveness to treatment and recurrence in patients with breast cancer, emotional well-being was assessed every 3 months for 2 years and at 1 and 6 months after recurrence in 1,169 patients who were premenopausal and 960 patients who were postmenopausal. These patients were enrolled in two International Breast Cancer Study Group randomized clinical trials in operable breast cancer conducted from 1986 to 1993. To assess concurrent validity, Pearson's correlations between the linear analogue self-assessment scale and the adjective checklist were calculated for each time-point within each treatment group and for the two assessments after recurrence. Responsiveness to treatment and recurrence were analyzed using paired t tests and the squared ratio of these t tests, an estimate of relative efficiency. Concurrent validity of the mood linear analogue self-assessment was consistently confirmed across four language groups. Both measures were responsive; out of 24 changes over time, 19 were in the expected direction for the linear analogue self-assessment scale (P ≤ 0.05 for 9 of 19) and 17 for the adjective checklist (P ≤ 0.05 for 10 of 17). The linear analogue self-assessment scale was less but sufficiently efficient for detection of treatment effects, with relative efficiency estimates ranging from 0.16 to 2.45 and a median of 0.66 among the comparisons with relatively stable estimates (|t| ≥ 1.0) and more efficient for recurrence than the adjective checklist. The mood linear analogue self-assessment scale is a valid indicator of emotional well-being in patients with breast cancer in large multicenter, multicultural trials in which comprehensive scales are less feasible. This investigation supports the clinical relevance of linear analogue self-assessment scales as indicators of components of quality of life in cancer clinical trials.

*From the Medical Division Lory, Inselspital, Bern, Switzerland.

From the IBCSG Coordinating Center, Bern, Switzerland.

From the Department of Medical Oncology, Royal Prince Alfred Hospital, Camperdown, Australia.

§From the IBCSG Statistical Center, Dana-Farber Cancer Institute, Division of Biostatistics and Epidemiology, Boston, Massachusetts.

From the Department of Surgery, Sahlgrenska Hospital, Göteborg, Sweden.

From the Royal Melbourne Hospital, Victoria, Australia.

#From the Department of Surgery, Institute of Oncology, Ljubljana, Slovenija.

††From the Servizio Oncologico, Ospedale Civico, Lugano, Switzerland.

‡‡From the Medizinische Klinik C, Kantonsspital, St. Gallen, Switzerland.

This study was supported by the Swiss Cancer League, Cancer League of Ticino, Swiss Group for Clinical Cancer Research, Australian-New Zealand Breast Cancer Trials Group, (grant numbers 880513 and 910420) Australian Cancer Society, Frontier Science, and Technology Research Foundation and a grant (PBR-53) from the American Cancer Society.

Part of these data was presented at Psycho-Oncology V Conference at the Memorial Sloan-Kettering Cancer Center, New York, October 2-4, 1993.

Address correspondence to: Christoph Hürny, MD, Medical Division Lory, Inselspital, CH-3010 Bern, Switzerland.

© Lippincott-Raven Publishers