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The objective of this study was to compare the health-related quality of life (HRQL) burden across different types of advanced cancer with the use of 2 widely used patient-reported outcome measures, the generic EQ-5D and the cancer-specific Functional Assessment of Cancer Therapy-General (FACT-G). Patients with advanced cancer of the bladder, brain, breast, colon/rectum, head/neck, hepatobiliary tract/pancreas, kidney, lung, lymphoma, ovary, or prostate completed the EQ-5D and FACT-G. HRQL domains and summary scores were compared across types of cancer, using regression models to adjust for age and sex. Approximately 50 patients with each type of cancer were recruited (total, 534 patients). According to EQ-5D dimensions, the highest proportion of problems was associated with prostate (mobility); prostate and kidney (self-care); head/neck, bladder, and lung (usual activities); breast, head/neck, and lung (pain/discomfort); and lymphoma and lung (anxiety/depression) cancers. EQ-5D visual analogue scale scores were lowest for breast and head/neck cancers; US index-based scores were lowest for breast and lung cancers and highest for brain cancer. For the FACT-G, physical well-being scores were lowest for head/neck, hepatobiliary, and kidney cancers; emotional well-being scores were lowest for hepatobiliary cancer, and functional well-being scores were lowest for head/neck, hepatobiliary, and bladder cancers. The overall and dimension-specific HRQL burden of advanced cancer depended on the type of cancer. Such results may aid clinicians and patients in better understanding of how cancer site can affect HRQL and functioning in different ways.

Background Although the use of patient-reported outcome measures (PROs) has increased markedly, clinical interpretation of scores remains lacking. We developed a method to identify clinical severity thresholds for pain, fatigue, depression, and anxiety in people with cancer. Methods Using available Patient-Reported Outcomes Measurement Information System (PROMIS) item bank response data collected on 840 cancer patients, symptom vignettes across a range of symptom severity were developed and placed on index cards. Cards represented symptom severity at five-point intervals differences on the T score metric [mean = 50; standard deviation (SD) = 10]. Symptom vignettes for each symptom were anchored on these standardized scores at 0.5 SD increments across the full range of severity. Clinical experts, blind to the PROMIS score associated with each vignette, rank-ordered the vignettes by severity, then arrived at consensus regarding which two vignettes were at the upper and lower boundaries of normal and mildly symptomatic for each symptom. The procedure was repeated to identify cut scores separating mildly from moderately symptomatic, and moderately from severely symptomatic scores. Clinician severity rankings were then compared to the T scores upon which the vignettes were based. Results For each of the targeted PROs, the severity rankings reached by clinician consensus perfectly matched the numerical rankings of their associated T scores. Across all symptoms, the thresholds (cut scores) identified to differentiate normal from mildly symptomatic were near a T score of 50. Cut scores differentiating mildly from moderately symptomatic were at or near 60, and those separating moderately from severely symptomatic were at or near 70. Conclusions The study results provide empirically generated PROMIS T score thresholds that differentiate levels of symptom severity for pain interference, fatigue, anxiety, and depression. The convergence of clinical judgment with self-reported patient severity scores supports the validity of this methodology to derive clinically relevant symptom severity levels for PROMIS symptom measures in other settings.

Objective: The objectives of this study were: 1) to determine whether expanding the number of levels (ie, response categories) on the standard 3 level EQ-5D (EQ-5D-3L) to 5-levels (EQ-5D-5L) would improve the descriptive richness and ability of the measure to discriminate among different levels of health, and 2) to examine the psychometric properties of each EQ-5D version in patients with cancer. Methods: U. S.-based cancer patients self-assessed their health using EQ-5D-3L and EQ-5D-5L. These versions were compared in terms of ceiling effects, convergent validity based on correlations with ECOG performance status and FACT-G, discriminative ability using Rasch analysis, and informational richness using Shannon's Evenness Index (J'). Results: A ceiling effect was observed among a greater proportion of respondents to EQ-5D-3L, n = 74/424 (17%), compared with EQ-5D-5L, n = 47/424 (11%). Within the midlevel of EQ-5D-3L (some problems), substantial partitioning of the sample into the 3 nonextreme levels of the EQ-5D-5L was observed across dimensions. EQ-5D-5L demonstrated a trend towards slightly stronger correlations with ECOG performance status compared with EQ-5D-3L for all dimensions of health, ie, ${\\rm{r}}_{\\rm{s}} \\left( {{\\rm{5L/3L}}} \\right){\\rm{:r}}_{{\\rm{mobility}}} {\\rm{ = 0}}{\\rm{.38/0}}{\\rm{.31;}}$ ${\\rm{r}}_{{\\rm{self - care}}} {\\rm{ = 0}}{\\rm{.35/0}}{\\rm{.31;}}$ ${\\rm{r}}_{{\\rm{usual}}\\,\\,{\\rm{activities}}} {\\rm{ = 0}}.{\\rm{55/0}}.{\\rm{47}};{\\rm{r}}_{{\\rm{pain/discomfort}}} {\\rm{ = 0}}.{\\rm{43/0}}.{\\rm{37}};$ ${\\rm{r}}_{{\\rm{pain/discomfort}}} {\\rm{ = 0}}{\\rm{.43/0}}{\\rm{.37;}}$ ${\\rm{r}}_{{\\rm{anxiety/depression}}} {\\rm{ = 0}}{\\rm{.23/0}}{\\rm{.16;}}$ ${\\rm{r}}_{{\\rm{crude}}\\,\\,{\\rm{summary}}\\,\\,{\\rm{score}}} {\\rm{ = 0}}{\\rm{.56/0}}{\\rm{.49}}{\\rm{.}}$ EQ-5D-5L demonstrated a greater relative efficiency and ability to discriminate different levels of health. Informational richness and evenness of EQ-5D-5L was slightly higher (J'5L = 0.75) than EQ-5D-3L (J'3L = 0.69). Conclusion: Evidence supported the validity of both EQ-5D-3L and EQ-5D-5L in cancer. However, results suggest a 5-level classifier system has less ceiling effect and greater discriminative ability with potentially more power to detect differences between groups compared with EQ-5D-3L.

Purpose Considerable research has demonstrated the negative psychosocial impact of cancer. Recent work has highlighted positive psychosocial outcomes. Research is now needed to evaluate the relationship between negative and positive impacts. This paper reports the development and validation of a measurement model capturing positive and negative psychosocial illness impacts. Methods The sample included 754 cancer patients on-or post-treatment. Item development was informed by literature review, expert input patient interviews and the results of a pilot study of 205 cancer patients, resulting in 43 positive and 46 negative items. Factor analyses were used to evaluate the dimensionality of the item pools. Analysis of variance (ANOVA) was used to examine relationships between psychosocial illness impact and other variables. Results Unidimensionality was demonstrated within but not across negative and positive impact items. ANOVA results showed differential relationships between negative and positive impacts, respectively, and patient sociodemographic and clinical variables. Conclusion Positive and negative psychosocial illness impacts are best conceptualized and measured as two independent factors. Computerized adaptive tests and short-form measures developed from this comprehensive psychosocial illness impact item bank may benefit future research and clinical applications.

Background: Expansion of the EQ-5D health state classifier to 5 levels (EQ-5D-5L) has been proposed to improve discriminative and evaluative properties, but current preference-based algorithms were developed for a 3-level (EQ-5D-3L) structure. The objectives were to examine equivalency of meaning between 3L and 5L response systems, and to psychometrically derive a system of weights that facilitate conversion of 3L preference-based algorithms to a 5L system. Methods: Rasch models were used to examine the equivalency of the 3L and 5L systems using 2 datasets where health status was assessed using the 3L and 5L: a Dutch study of primarily hypothetical health state assessments and a US-based multicenter study of 423 cancer patients. Category-specific mean values of latent person parameters (using maximum likelihood estimation) for the levels of the 3L and 5L systems were estimated. Results: Means on the latent continuum pertaining to level 3 in the 5L system and level 2 in the 3L (some problems) were similar for both datasets, suggesting equivalence of these levels. Extremes of the 5L response structure consistently broadened the measurement continuum. By anchoring \"no problems\" as 0 disutility, disutility weights from EQ-5D-3L were transformed into weights for EQ-5D-5L using ratios of logit distances between person means for 5L and 3L calibrated for each dimension using the Rasch model. Conclusions: This study illustrates the rich potential for modern psychometric techniques both to examine equivalency when health status measures are modified as well as to inform preference-based measurement systems using existing value sets.

Identifying health-related quality of life concerns is a priority when caring for people with cancer. Specific problem areas such as pain, fatigue, emotional distress, disease- and treatment-related symptoms, as well as physical functioning can be routinely assessed using applications that draw upon item response theory. Item response theory measurement models can improve on the classical approach to health-related quality of life assessment with advantages that include comparison of patients across diverse instruments, flexibility in degree of precision desired, availability of multiple short forms, interval measurement and capability for individual assessment (real-time clinical monitoring) using computerized adaptive testing. This review describes a model of health-related quality of life in oncology and the contribution of item response theory to assessment using that model.