Abstract
BackgroundSingle-item assessments have been the most often-used measures in National Cancer Institute (NCI) cancer control clinical trials, but normative data are not available. Our objective was to examine the normative data and clinically significant effect sizes for single-item numerical linear analogue self-assessment (LASA) scale for overall quality of life (QOL).MethodsWe analyzed baseline data from 36 clinical trials and 6 observational studies with various populations, including healthy volunteers, cancer trial patients (patients with advanced incurable cancer or patients receiving treatment with curative intent) and hospice patients as well as their caregivers. The overall QOL LASA was rated 0 (as bad as it can be) to 10 (as good as it can be). We calculated the summary statistics and the proportion of patients reporting a clinically meaningful deficit (CMD) of a score equal to 5 or less on the 0–10 scale.ResultsIn total, for the collective sample of 9,295 individuals, the average overall QOL reported was 7.39 (SD = 2.11) with a markedly skewed distribution with roughly 17% reporting a score of 5 or below indicating a clinically significant deficit in overall QOL. Hospice patients report a much worse average score of 5.7 upon entry to hospice; hospice caregivers average 7.4. Cancer patients vary within these two extremes with most patients averaging in the 7’s on the 0–10 scale (range, 0 to 10 p-value < 0.0001). Men and women’s QOL distributions were virtually identical (with average of 7.6 vs. 7.5, p-value = 0.046). Overall QOL was weakly related to performance status with a Spearman correlation coefficient of −0.29 (p-value < 0.0001). Overall QOL was related to tumor response (p-value = 0.0094), i.e. patients with a full or partial response reported a CMD in 11.4% of cases compared to 14.4% among those with stable disease and 18.5% among those with disease progression. Data missingness was high for performance status and tumor response associations.ConclusionsThis study provides the normative data for cancer patients and healthy volunteers for overall QOL using the LASA. These can serve as benchmarks for future studies and inform clinical practice decision-making.Electronic supplementary materialThe online version of this article (doi:10.1186/s12955-014-0187-z) contains supplementary material, which is available to authorized users.
Highlights
Single-item assessments have been the most often-used measures in National Cancer Institute (NCI) cancer control clinical trials, but normative data are not available
This paper presents a series of normative data for overall quality of life (QOL) linear analogue self-assessment (LASA) scale (Additional file 1) drawn from different populations ranging from healthy volunteers to hospice patients
Hospice patients report a much worse average score of 5.7 upon entry to hospice, it has been seen that their QOL will improve after hospice care has been initiated [25]
Summary
LASA only refers to the type of response scale, but has come to be associated with simple single-item PRO measures in clinical research This is partially due to the wide application of these simple measures and the ready acceptance by clinical researchers and clinicians. Single-item tools are in widespread use, for example JCAHO has mandated that single-item pain assessments be completed at the time of every clinical intake for institutions to maintain accreditation [14] The incorporation of these requirements into clinical practice presumes patient care has improved the evidence is inconsistent [15]. A PRO Outcome Measurement System (PROMIS) paper compared a single-item pain measure to a longer assessment and indicated that the two were psychometrically similar but complimentary [16] This would seem to indicate that there is a place for both in the clinical trials armamentarium
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