Normative data and clinically significant effect sizes for single-item numerical linear analogue self-assessment (LASA) scales

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.

The level of association between functional performance status measures and patient-reported outcomes in cancer patients: a systematic review

“…Over half of the studies ( k =10) used ECOG PS to assess FPS [15–24], with four using KPS [5, 25–27], one using a modified version of KPS known as the Palliative Performance Status (PPS; [28]) [29], one making use of the patient-reported National Comprehensive Cancer Network-Functional Assessment of Cancer Therapy–Kidney Symptom Index (NFKSI) [30], one using the patient-reported Performance Status Scale–Head and Neck Cancer (PSS-HNC; [31]) [32], and one cooperative group study that used a variety of FPS measures, including ECOG PS and KPS [33]. Basch and colleagues [5], in addition to using KPS to assess patient FPS, administered a patient-reported version of KPS scaled from 0 to 100.…”

“…Other PRO measures administered included the Hospital Anxiety and Depression Scale (HADS; [38]), the MD Anderson Symptom Assessment Inventory (MDASI; [39]), the Brief Pain Inventory (BPI; [40, 41]), linear analogue self assessment (LASA; [33]), and Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29 [42]). The SF-36 and FACT-G/FACIT assessment tools are widely used measures of global QoL, including emotional, physical, social, and functional well-being.…”

“…These included two studies that specifically captured patient-reported fatigue via the FACIT-F (i.e., r =0.43 [26] and r =−0.55 [16]), as well as a study that examined the level of association between FPS and PROs in patients undergoing treatment with biological response modifiers (i.e., ECOG PS vs. patient global rating of change for emotional well-being [ r range 0.11–0.24], emotional-well being [ r range 0.09–0.23], and change in physical functioning and well being [ r range 0.25–0.37] [23]. A multicenter study that consisted of healthy volunteers and cancer trial patients, as well as hospice patients and their caregivers ( N =9295) reported a significantly negative association between FPS and overall QoL, as measured by LASA ( r =−0.29, p <0.0001) [33]. …”

Healthy immigrant families: Participatory development and baseline characteristics of a community-based physical activity and nutrition intervention

“…Blood pressure was measured twice, with 1 minute between readings, and averaged readings were used in the analysis. Health-related quality of life was measured by single-item linear analog scale assessments of physical, emotional, and overall health (52,53). …”

A randomized comparison of once weekly epoetin alfa to extended schedule epoetin or darbepoetin in chemotherapy‐associated anemia

“…Secondary endpoints included RBC transfusion requirements, adverse events (AEs), and Patient Reported Outcomes (PROs). PROs were measured using several validated tools: the Symptom Distress Scale (SDS) [18], Brief Fatigue Inventory (BFI) [19], Functional Assessment of Cancer Therapy Anemia (FACT-An) [20], and Linear Analog Self Assessment (LASA) [21]. Adverse events were reported using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 3.0.…”