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Background: Survivors of childhood brain tumors experience persistent health concerns across their lifespan. In the current study, the authors evaluated changes in symptom burden over the course of 12 months using pediatric Patient-Reported Outcomes Measurement Information System (PROMIS) measures., Methods: Data from 202 survivors aged 8 to 21 years and 262 parents of survivors who were aged 5 to 21 years were analyzed. All completed a PROMIS Cognition short form and computerized adaptive tests of pediatric Anxiety, Depressive Symptoms, Fatigue, Mobility, Upper Extremity Function, and Peer Relationships. Approximately one-half of participants (223 participants: 97 survivors of childhood brain tumors and 126 parents) completed the 12-month follow-up. Linear mixed-effects models evaluated group-level symptoms over time. Cox proportional hazard models explored whether symptoms predicted survival, and latent class growth analysis investigated patterns of individual-level symptom changes over time., Results: Linear mixed-effects models demonstrated that patient-reported Cognition and parent-reported Anxiety worsened over time. Latent class growth analysis results indicated that patient and parent reports diverged, both with regard to the number of classes identified and in the trends of these classes. Parents and patients reported similar patterns of depression over time. For the other areas, parents either were more likely to observe different patterns (Peer Relationships and Mobility) or less likely to observe different patterns (Upper Extremity Function, Cognition, Anxiety, and Fatigue). Baseline patient-reported Mobility and Upper Extremity Function were found to be associated with survival., Conclusions: Survivors of childhood brain tumors demonstrated different trajectory patterns of symptom burden. Along with baseline functioning status and days since treatment, patient-reported Mobility and Upper Extremity Function were associated with survival, suggesting a possible role for patient-reported outcomes in clinical care, especially individualized, tailored assessments such as PROMIS., (© 2020 American Cancer Society.)

Purpose: Evidence has shown that cancer-related fatigue (CRF) may be a treatment-limiting symptom and often impairs health-related quality of life. Accurate assessment of the multidimensional nature of CRF could help drive interventions to mitigate this debilitating symptom. Currently, there are no clinical tools to effectively and efficiently assess the multidimensionality of CRF. The purpose of this paper is to introduce a CRF-specific short form that can assess the multidimensional nature of CRF for use in the clinical setting., Methods: The CRF-specific short form was developed using the 95-item PROMIS® fatigue bank. Bi-factor analysis was used to evaluate dimensionality of the alternative model using fatigue for the general factor and physical, cognitive, affective, global, and motivational for the local factors. After unidimensionality was confirmed (loading factor > 0.3), one item from each local factor was selected using discrimination power for inclusion in the CRF-specific short form., Results: The Research Assessment and Clinical Tool-Fatigue (ReACT-F) was created from the 95-item PROMIS fatigue bank using established item parameters. The ReACT-F assesses five common dimensions of CRF as well as perceived burden of the fatigue dimensions., Conclusions: The ReACT-F is a CRF-specific self-report short form that addresses the need for a brief, clinically useful tool to quickly assess the multidimensional nature of CRF. We anticipate that the ReACT-F can be completed in the clinical setting in approximately 3 minutes, providing clinicians with meaningful data to drive personalized interventions. Further validation of the ReACT-F is highly encouraged.

Background: Children with brain tumors can experience symptom burden throughout their disease continuum. The aim of the study was to evaluate symptom burden reported by children with brain tumors and factors that potentially were associated with their symptoms., Methods: Data from 199 children with brain tumors aged 7-22 (mean age = 14 years; 52% males; 76% white) were analyzed. Symptom burden was assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) via computerized adaptive testing (CAT)-anxiety, depression, fatigue, mobility, upper extremity function, peer relationship, and cognition. Patients and parents completed Symptom Distress Scales (SDS). Test statistics and ANOVA were used to evaluate relationships between PROMIS measures and potentially influential variables., Results: Significant results (P < 0.01) showing impact of symptom burden included: PROMIS measures correlated with SDSs reported by patients and parents on all comparisons. Fatigue, mobility, and upper extremity function were associated with Karnofsky functional performance status, number of treatment modalities (0-3), and time since last treatment (≤1 year, >1 year). Fatigue and cognition were associated with educational program (regular classroom without an individualized education plan vs those that had an individualized education plan); mobility and upper extremity function were associated with time since last radiation. Mobility, upper extremity function, and anxiety were associated with time since last chemotherapy., Conclusions: Significant associations were found between PROMIS and SDS as well as clinical and demographic characteristics. Brief-yet-precise PROMIS CATs can be used to systematically assess symptom burden experienced by children with brain tumors., (© 2018 Wiley Periodicals, Inc.)

Purpose: Survivors of pediatric Hodgkin's lymphoma (HL) are at risk for a number of debilitating late effects. Excessive fatigue and poor sleep quality are primary complaints of HL survivors. Understanding the emotional and physical factors that influence fatigue and sleep quality may provide opportunities for intervention to improve health-related quality of life for HL survivors., Methods: Data from 751 adult survivors of childhood HL who participated in the Childhood Cancer Survivor Study (CCSS) from 2000-2002 were analyzed. Multivariable logistic regression analyses investigated the demographic, psychological, and physical variables that predicted clinically significant levels of poor sleep quality, fatigue, and excessive daytime sleepiness., Results: Survivors' self-reported level of emotional distress, pain, and physical functioning limitations did not differ from population norms. Clinically elevated levels of emotional distress (OR 8.38, 95% CI 4.28-16.42) and pain (OR 3.73, 95% CI 2.09-6.67) increased the risk for endorsing elevated levels of fatigue. Survivors with elevated levels of emotional distress (OR 6.83, 95% CI 2.71-15.90) and pain (OR 5.27, 95% CI 1.78-15.61) were more likely to report poor sleep quality. Pain (OR 2.11, 95% CI 1.39-3.34) was related to excessive daytime sleepiness., Conclusions: Emotional and physical factors are associated with elevated levels of fatigue, excessive daytime sleepiness, and poor sleep quality in survivors of pediatric HL. This is consistent with findings from research conducted with non-cancer survivors., Implications for Cancer Survivors: These results suggest that interventions designed to target sleep and fatigue difficulties in the general population may be well suited for pediatric HL survivors as well.

Systemic lupus erythematosus (SLE) is a multi-organ chronic autoimmune disease that can negatively affect patients' health-related quality of life (HRQOL). This study evaluated HRQOL of SLE patients using questionnaires from the Patient-Reported Outcomes Measurement Information System (PROMIS) and Quality of Life in Neurological Disorders (Neuro-QoL). Individuals with SLE completed an online survey consisting of the PROMIS-29 health profile, PROMIS Psychosocial Illness Impact-Negative, and Neuro-QoL Applied Cognition. PROMIS and Neuro-QoL scores have a mean of 50 in the US general population. Patients self-rated SLE disease severity as negligible, mild, moderate, or severe. Of the 333 participants (mean age 45 years; 92% female; 26% Black; mean SLE disease duration 12 years, 56% with SLE disease severity as moderate or severe), mean HRQOL scores were worse than those of the general population by ≥0.5 SD with the greatest deficits observed in the domains of fatigue, applied cognition, psychosocial illness impact-negative, pain interference, and physical function. Greater SLE disease severity was associated with worse mean HRQOL scores (all p < 0.05). Pain severity was also associated with worse HRQOL scores on all domains (p < 0.05) except for satisfaction with social role. Test-retest reliability exceeded 0.70 for all PROMIS and Neuro-QoL scores. PROMIS-29 and Neuro-QoL are valid tools to assess HRQOL in patients with SLE. These patients reported substantial deficits that correlated with their SLE disease severity, with pain being an important independent contributor. These deficits should be monitored in SLE patients during their routine clinical care and evaluated when investigating new therapies.

Objective: To evaluate the comparability and responsiveness of Patient-Reported Outcomes Measurement Information System (PROMIS) fatigue item bank across six chronic conditions., Study Design and Setting: Individuals (n = 1,430) with chronic obstructive pulmonary disease (n = 125), chronic heart failure (n = 60), chronic back pain (n = 218), major depressive disorder (n = 196), rheumatoid arthritis (n = 521), and cancer (n = 310) completed assessments from the PROMIS fatigue item bank at baseline and a clinically relevant follow-up. The cancer and arthritis samples were followed in observational studies; the other four groups were enrolled immediately before a planned clinical intervention. All participants completed global ratings of change at follow-up. Linear mixed-effects models and standardized response means were estimated to examine clinical validity and responsiveness to change., Results: All patient groups reported more fatigue than the general population (range = 0.2-1.29 standard deviation worse). The four clinical groups with pretreatment baseline data experienced significant improvement in fatigue at follow-up (effect size range = 0.25-0.91). Individuals reporting better overall health usually experienced larger fatigue changes than those reporting worse overall health., Conclusion: The results support the PROMIS fatigue measures's responsiveness to change in six different chronic conditions. In addition, these results support the ability of the PROMIS fatigue measures to compare differences in fatigue across a range of chronic conditions, thereby enabling comparative effectiveness research., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Purpose: Carnitine deficiency has been found in cancer patients and has been associated with fatigue. This study aimed to explore the prevalence of carnitine deficiency in pediatric cancer patients and its relationship with fatigue and other potential contributing factors., Methods: Children with cancer or Langerhans cell histiocytosis who were receiving treatment or had completed therapy were eligible. Patients completed the Pediatric Functional Assessment of Chronic Illness-Fatigue, the Pediatric Quality of Life Inventory Multidimensional Fatigue Scale, a numeric fatigue rating, and had carnitine levels obtained. Carnitine deficiency was defined as a total and/or free carnitine level less than normal for age or an acylcarnitine value higher than normal for age., Results: Data from 142 children aged 8-17 were analyzed. Twenty-eight of 142 (19.7 %) had decreased total and 42.8 % (12/28) had decreased free carnitine levels. No patients had elevated acylcarnitine levels or elevated ratios. Patients with versus without carnitine deficiency differed by age (p = 0.043), treatment (p = 0.037), duration since last chemotherapy (p = 0.020), and body mass index (p = 0.010), but not fatigue, when all data were analyzed together. Yet, a negative relationship between fatigue and carnitine levels was found on a subgroup (off-therapy; fatigue worse than the norm)., Conclusion: No significant association between fatigue and carnitine level was demonstrated when data from all patients were analyzed together; however, a significant yet unexpected relationship was found for patients who completed therapy and reported elevated fatigue. Given the small sample size, these results should be interpreted with caution. Future studies to explore impact upon excessive carnitine levels are warranted.

Background: This study evaluated the feasibility of implementing a patient-centered, technology-based symptom monitoring and reporting system (SyMon-SAYS) in pediatric oncology clinics using fatigue as a prototypic symptom. Timely identification of symptoms related to multi-modal therapy for children with cancer is fundamental to the overall success of cancer treatment. SyMon-SAYS was developed to address this need., Procedure: Patients with a cancer diagnosis, ages 7-21 years, currently on treatment, or off treatment within 6 months, were eligible. Patients/parents completed weekly fatigue assessments over 8 weeks via the internet or interactive voice response (IVR) by phone. Alert emails were generated when pre-defined fatigue score thresholds were met, and fatigue reports were forwarded to clinicians accordingly. Clinicians and parents/patients received cumulative graphic reports of fatigue scores prior to clinic visits at 4 and 8 weeks post-baseline to facilitate discussion. Parents/patients completed an exit survey at their last visit., Results: Fifty-seven patients/parents completed the study. The majority of patients (93%) and parents (78%) felt it was very/extremely easy to complete SyMon-SAYS; 95% of parents were satisfied with the system; 60% reported it helped deal with their child's fatigue; 70% reported that clinicians didn't discuss fatigue with them; 81% would be willing to use SyMon-SAYS to manage fatigue and other symptoms. Clinicians reported insufficient time to review reports, yet 71% were willing to receive the report on a monthly basis., Conclusion: SyMon-SAYS is feasible and acceptable to patients and parents. Future efforts should focus on better integrating the system into the clinical workflow to improve clinicians' acceptance., (© 2015 Wiley Periodicals, Inc.)

Context: Fatigue is one of the most common and debilitating symptoms experienced by patients living with chronic conditions and is also commonly experienced in the general U.S. population. Linking fatigue scores from some of the most widely used measure of fatigue to the same metric will facilitate interpretation of fatigue outcomes., Objectives: The goal of this study is to report the methods used to develop linking (crosswalk) tables to enable the direct comparison of Patient-Reported Outcomes Measurement Information System-Fatigue with fatigue scores on the Functional Assessment of Chronic Illness Therapy-Fatigue Scale, the Medical Outcomes Study Short Form-36 four-item Vitality Scale, and the Quality of Life in Neurological Disorders Fatigue Scale., Methods: Participants were recruited from two data sets (n=1120 and n=803). Two item response theory-based linking methods, the Stocking-Lord calibration and fixed-parameter calibration, were used to establish linking between measures. The item response theory calibrations were derived using the graded response model., Results: Both the Stocking-Lord calibration and fixed-parameter calibration linking methods produced comparable results. Final crosswalk tables are reported for the fixed-parameter calibration., Conclusion: Findings can facilitate comparison of scores across some of the most widely used fatigue measures and assist in comparing patient-reported fatigue outcomes in clinical trials, comparative effectiveness research, and clinical practice., (Copyright © 2014 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.)

Purpose: This paper reports on the development and psychometric properties of self-reported pediatric fatigue item banks as part of the Patient-Reported Outcomes Measurement Information System (PROMIS)., Methods: Candidate items were developed by using PROMIS qualitative methodology. The resulting 39 items (25 tiredness related and 14 energy related) were field tested in a sample that included 3,048 participants aged 8-17 years. We used confirmatory factor analysis (CFA) to evaluate dimensionality and differential item functioning (DIF) analysis to evaluate parameter stability between genders and by age; we examined residual correlations to evaluate local dependence (LD) among items and estimated the parameters of item response theory (IRT) models., Results: Of 3,048 participants, 48 % were males, 60 % were white, and 23 % had at least one chronic condition. CFA results suggest two moderately correlated factors. Two items were removed due to high LD, and three due to gender-based DIF. Two item banks were calibrated separately using IRT: Tired and (Lack of) Energy, which consisted of 23 and 11 items, respectively; 10- and 8-item short-forms were created., Conclusion: The PROMIS assessment of self-reported fatigue in pediatrics includes two item banks: Tired and (Lack of) Energy. Both demonstrated satisfactory psychometric properties and can be used for research settings.

Over the past decades, some scientific progress has been made in understanding and treating cancer-related fatigue (CRF). However, three major problems have limited further progress: lack of agreement about measurement, inadequate understanding of the underlying biology, and problems in the conduct of clinical trials for CRF. This commentary reports the recommendations of a National Cancer Institute Clinical Trials Planning Meeting and an ongoing National Cancer Institute working group to address these problems so that high-priority research and clinical trials can be conducted to advance the science of CRF and its treatment. Recommendations to address measurement issues included revising the current case definition to reflect more rigorous criteria, adopting the Patient Reported Outcomes Measurement Information System fatigue scales as standard measures of CRF, and linking legacy measures to the scales. With regard to the biology of CRF, the group identified the need for longitudinal research to examine biobehavioral mechanisms underlying CRF and testing mechanistic hypotheses within the context of intervention research. To address clinical trial issues, recommendations included using only placebo-controlled trial designs. setting eligibility to minimize sample heterogeneity or enable subgroup analysis, establishing a CRF severity threshold for participation in clinical trials, conducting dissemination trials of efficacious interventions (such as exercise), and combining nonpharmacologic and pharmacologic interventions to exploit the potential synergy between these approaches. Accomplishing these goals has the potential to advance the science of CRF and improve the clinical management of this troubling symptom.

Objective: To examine the relationships among pediatric fatigue, health-related quality of life (HRQOL), and family impact among children with special health care needs (CSHCNs), specifically whether HRQOL mediates the influence of fatigue on family impact., Methods: 266 caregivers of CSHCNs were studied. The Pediatric Quality of Life Inventory Multidimensional Fatigue Scale, Pediatric Quality of Life Inventory Generic Scale, and Impact on Family Scale were used to measure fatigue, HRQOL, and family impact, respectively. Linear regressions were used to analyze the designated relationships; path analyses were performed to quantify the mediating effects of HRQOL on fatigue-family impact relationship., Results: Although greater fatigue was associated with family impact (p < .05), the association was not significant after accounting for HRQOL. Path analyses indicated the direct effect of fatigue on family impact was not significant (p > .05), whereas physical and emotional functioning significantly mediated the fatigue-family impact relationship (p < .001)., Conclusion: Fatigue is related to family impact among CSHCNs, acting through the impairment in HRQOL.

Objective: Given the importance of fatigue in cancer, stroke and HIV, we sought to assess the measurement properties of a single, well-described fatigue scale in these populations. We hypothesized that the psychometric properties of the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) subscale would be favorable and that the scale could serve as a useful indicator of fatigue in these populations., Methods: Patients were eligible for the study if they were outpatients, aged 18 or older, with a diagnosis of cancer (n=297), stroke (n=51), or HIV/AIDS (n=51). All participants were able to understand and speak English. Patients answered study-related questions, including the FACIT-F using a touch-screen laptop, assisted by the research assistant as necessary. Clinical information was abstracted from patients' medical records., Results: Item-level statistics on the FACIT-F were similar across the groups and internal consistency reliability was uniformly high (α>0.91). Correlations with performance status ratings were statistically significant across the groups (range r=-0.28 to -0.80). Fatigue scores were moderately to highly correlated with general quality of life (range r=0.66-0.80) in patients with cancer, stroke, and HIV. Divergent validity was supported in low correlations with variables not expected to correlate with fatigue., Conclusions: Originally developed to assess cancer-related fatigue, the FACIT-F has utility as a measure of fatigue in other populations, such as stroke and HIV. Ongoing research will soon allow for comparison of FACIT-F scores to those obtained using the fatigue measures from the Patient-Reported Outcomes Measurement Information System (PROMIS®; www.nihpromis.org) initiative., (Copyright © 2012 Elsevier Inc. All rights reserved.)

Objective: To illustrate how measurement practices can be advanced by using as an example the fatigue item bank (FIB) and its applications (short forms and computerized adaptive testing [CAT]) that were developed through the National Institutes of Health Patient Reported Outcomes Measurement Information System (PROMIS) Cooperative Group., Design: Psychometric analysis of data collected by an Internet survey company using item response theory-related techniques., Setting: A U.S. general population representative sample collected through the Internet., Participants: Respondents used for dimensionality evaluation of the PROMIS FIB (N=603) and item calibrations (N=14,931)., Interventions: Not applicable., Main Outcome Measures: Fatigue items (112) developed by the PROMIS fatigue domain working group, 13-item Functional Assessment of Chronic Illness Therapy-Fatigue, and 4-item Medical Outcomes Study 36-Item Short Form Health Survey Vitality scale., Results: The PROMIS FIB version 1, which consists of 95 items, showed acceptable psychometric properties. CAT showed consistently better precision than short forms. However, all 3 short forms showed good precision for most participants in that more than 95% of the sample could be measured precisely with reliability greater than 0.9., Conclusions: Measurement practice can be advanced by using a psychometrically sound measurement tool and its applications. This example shows that CAT and short forms derived from the PROMIS FIB can reliably estimate fatigue reported by the U.S. general population. Evaluation in clinical populations is warranted before the item bank can be used for clinical trials., (Copyright © 2011 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.)

Objective: To investigate demographic correlates of fatigue in the US general population using a new instrument developed by the Patient-Reported Outcome Measurement Information System (PROMIS). First, we examined correlations between the new PROMIS instrument and the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) and the SF-36v2 Vitality subscale. Based on prior findings, we further examined several demographic correlates of fatigue: whether women would report higher levels of fatigue compared to men, and whether married people would experience lower levels of fatigue compared to unmarried people. We also explored the relationship between age, education, and fatigue., Methods: Analyses were based on fatigue ratings by 666 individuals from the general population. Fatigue was assessed with the new PROMIS instrument, the FACIT-F, and the SF-36v2 Vitality subscale. Differences in fatigue were examined with independent samples t-tests and univariate ANOVAs., Results: The three fatigue instruments were highly intercorrelated. Confirming prior reports, women reported higher levels of fatigue than men. Married participants reported significantly less fatigue than their unmarried counterparts. Univariate ANOVAs yielded a main effect for participants' age; younger participants gave significantly higher fatigue ratings. We also found a main effect for participants' education. Participants with a masters or doctoral degree had significantly lower ratings of fatigue than participants with some college education and education up to high school., Conclusion: Female gender, not being married, younger age and lower educational attainment were each associated with increased fatigue in the general population and the three fatigue instruments performed equally well in detecting the observed associations., (Copyright © 2011. Published by Elsevier Inc.)

Across two general population (total n=1,878) and two cancer (total n=3,140) samples, we evaluated the dimensionality of self-reported fatigue as measured by the Functional Assessment of Chronic Illness Therapy--Fatigue (FACIT-F) instrument. After evaluating dimensionality of the FACIT-F, we compared the conceptually distinct fatigue experience versus fatigue impact scores in each sample. Confirmatory factor analysis of the 13-item scale showed very good fit to a single dimension ("unidimensional") model for each sample (comparative fit index range=0.92-0.97). Using a bifactor model to compare the loading of each item with the general fatigue factor versus the identified sub-domain (experience or impact), we found the item-general loading to be higher than that of the item-sub-domain factor in 52 of 52 comparisons (13 items; four samples). When scored separately, experience and impact scores were correlated highly (range=0.80-0.88), yet their difference relative to one another was significant (p<0.001). Consistently across samples, experience scores were systematically higher (more endorsement) than impact scores, by a margin of 0.21-0.46 SD units. This suggests that the fatigue experience and the impact of fatigue upon function are reported along a single dimensional continuum, but that experience is more likely than impact upon function to be endorsed at lower levels of fatigue. Fatigue as an outcome or trial endpoint can be expressed as a single number, and the experience of the symptom is more likely to be endorsed at mild levels of fatigue, presumably before the symptom exerts an adverse impact upon function.

Objective: Fatigue is a common symptom of systemic lupus erythematosus (SLE). Our objective was to validate the 13-item Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue scale in patients with SLE., Methods: The FACIT-Fatigue, Medical Outcomes Study Short-Form-36 (SF-36) questionnaire, Brief Pain Inventory (BPI), and Patient Global Assessment Visual Analog Scale (Patient-GA) were completed at baseline and at Weeks 12, 24, and 52 by patients with moderately to severely active extrarenal SLE. The patients were participating in a rituximab clinical trial. The British Isles Lupus Assessment Group (BILAG) disease activity index and the Physician Global Assessment Visual Analog Scale (Physician-GA) were completed by physicians at the same visits., Results: At baseline, 254 patients completed the FACIT-Fatigue scale. Cronbach's α was > 0.95 at all visits. In cross-sectional analyses, FACIT-Fatigue scores differentiated between groups defined by BILAG General domain ratings. FACIT-Fatigue had moderate-high correlations (r = 0.5-0.8) with SF-36, BPI, and Patient-GA, but poor correlations with BILAG total score and Physician-GA (r = 0.1-0.3). At Weeks 12, 24, and 52, mean FACIT-Fatigue scale improvement was higher in patients who improved versus those who remained unchanged on the BILAG General domain. FACIT-Fatigue scale scores remained stable for patients with worsened BILAG General domain ratings compared to baseline. Distribution and anchor-based estimates suggested a minimally important difference (MID) range of 3-6 points., Conclusion: The FACIT-Fatigue scale is a valid and responsive measure of fatigue in patients with SLE. MID in this SLE sample is similar to that derived previously in other populations. Since few patients experienced worsening BILAG General and Musculoskeletal domains in this study, further research is warranted to evaluate the responsiveness of FACIT-Fatigue to worsening of these domains.

Context: There has been some suggestion that the fatigue experienced by older cancer patients is more severe than that of younger cohorts; however, there is little empirical evidence to support this claim., Objectives: The goal of the present study was to determine the differential impact of age and cancer diagnosis on ratings of fatigue using a validated self-report instrument., Methods: The Functional Assessment of Chronic Illness Therapy-Fatigue subscale consists of 13 items measuring fatigue experience and its impact on daily life, with scores ranging from 0 (severe fatigue) to 52 (no fatigue). Fatigue data were available from the U.S. general population (n=1075; 51.3% female, 45.9+/-16.5 years) and a sample of mixed-diagnosis cancer patients (n=738; 64.3% female, 58.7+/-13.6 years). General population participants were recruited using an Internet-based survey panel; patients with cancer were recruited from Chicago-area oncology clinics., Results: On average, the cancer patient group reported more severe fatigue than the general population group (36.9 vs. 46.6; F[1,1797]=271.95, P<0.001). There was evidence for increased fatigue with age (F[6,719]=2.56, P<0.02) among patients with cancer, but not in the general population (P=0.06). Furthermore, the group x age interaction was not significant (P=0.44). Hemoglobin (Hgb) was treated as a covariate for 430 patients with available data; there was no main effect for age in this analysis., Conclusion: Older adults, whether they had a cancer diagnosis, reported more fatigue than younger adults. These differences may be explained, in part, by Hgb level. Future research would be helpful to explore longitudinal changes in fatigue in the general population and guide fatigue management for the older cancer patient., (Copyright (c) 2010 U.S. Cancer Pain Relief Committee. Published by Elsevier Inc. All rights reserved.)

The shared goal of all clinical disciplines is to optimize the well-being of people who become patients and find themselves diminished by illness and recovery. This goal relies on sound tools to evaluate both real and perceived deficits in a way that can be used for a particular patient over time and also across medical disciplines and patient populations. Fatigue is a critical and notoriously subjective aspect of many illnesses. Although the soundness of research is often correlated with the objectivity of data, certain clinical measures must, by definition, be patient centered, with all the complexities and challenges of patient-reported evaluations. Measurement of fatigue has been an important and evolving component of symptom management in the field of oncology. The Functional Assessment of Chronic Illness Therapy Fatigue Scale is a self-administered fatigue-assessment tool that has found wide application across diverse medical fields and that has demonstrated validity and utility across a broad range of populations. The Functional Assessment of Chronic Illness Therapy Fatigue Scale has become one in a repository of tools in the item banks that are accumulating under the auspices of The Patient-Reported Outcomes Measurement Information System, a National Institutes of Health initiative to deploy the most clinically relevant and technologically agile tools that we have to advance research in medicine and patient care. As much as with any other discipline, physical medicine and rehabilitation stands to gain from the collective knowledge and creative horizons in the assessment and treatment of fatigue., (Copyright (c) 2010 American Academy of Physical Medicine and Rehabilitation. Published by Elsevier Inc. All rights reserved.)

Objective: This study compared self-reported fatigue between 7-day and 4-week time frames and explored factors that affect patients' responses., Study Design and Setting: Two hundred and sixteen cancer patients completed either 7-day or 4-week version of the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F). Cochran-Mantel-Haenszel statistics and Cochran-Armitage trend tests were used to assess the association between time frame and item scores. Information function curves at both item and scale levels were depicted to evaluate the precision along the fatigue continuum. Differential item functioning (DIF) was used to examine the stability of the psychometric properties between time frames., Results: Time frame did not influence patients' item responses. Examination of information function curves at item level did not clearly favor either time frame. At the scale level, the 7-day time frame was slightly more precise overall than the 4-week time frame. No item demonstrated DIF between time frames. Neither gender nor fatigue severity had an impact on above results., Conclusion: This study suggests 7-day and 4-week time frame are equally appropriate in measuring fatigue, preference might be given to the more informative 7-day time frame. However, substantive considerations regarding the appropriate time frame should outweigh statistical ones.

Goals of Work: Fatigue is the most common symptom associated with cancer and its treatment. The present study measured patient and provider perceptions of the feasibility and acceptability of conducting computerized fatigue assessments during routine follow-up outpatient clinic visits., Materials and Methods: A subset of 64 patients from a larger study, testing items for inclusion in a fatigue item bank, completed two computerized fatigue assessments at 2- to 3-month intervals. After the second assessment, patients completed a questionnaire about the usefulness of the assessments and the understandability of graphic reports depicting the fatigue scores. They were also asked about the optimal frequency for conducting fatigue assessments. Providers were asked similar feasibility questions., Main Results: Providers thought displays of fatigue scores would be more useful than patients did. Patients and providers also differed on the frequency with which fatigue assessments should be conducted. Interestingly, of the 37% of patients who reported that assessments should be conducted at a different frequency than the choices that were offered, 50% reported that the assessments should be conducted according to their treatment schedule. The majority of providers thought fatigue assessments should be administered at each MD visit., Conclusion: Patients and providers differed about the perceived usefulness of displaying fatigue scores and the frequency with which routine assessments should be conducted. However, both patients and providers appeared to endorse the notion that routine assessments would be beneficial. Integration of routine assessments of commonly experienced symptoms such as fatigue may have important implications for improving symptom management in the future, ultimately resulting in better overall patient care.

Fatigue is a major concern for cancer patients of all ages. The lack of an appropriate assessment tool has impeded our understanding of its prevalence and significance, specifically in the pediatric cancer population. This paper documents the reliability and validity of the pediatric Functional Assessment of Chronic Illness Therapy-Fatigue (pedsFACIT-F) in a comprehensive manner. The 11-item PedsFACIT-F was developed via literature review, feedback from patient/parent/clinician, and a face-to-face consensus meeting. Its reliability and validity were examined on the basis of data from 159 pediatric patients with cancer via classical test theory and Rasch analysis. Results showed that the pedsFACIT-F demonstrated good internal consistency (Cronbach alpha), acceptable item-total correlations, and met the unidimensionality assumption set by confirmatory factor analysis. All items had acceptable fit statistics in the Rasch analysis and demonstrated stable measurement properties by age, sex, and cancer type. Scores on the pedsFACIT-F significantly discriminated between patients with and without anemia and among patients with different functional status; clinically relevant minimally important differences were estimated accordingly. The pedsFACIT-F was significantly correlated to the PedsQL Multidimensional Fatigue Scale. In conclusion, the pedsFACIT-F demonstrates satisfactory reliability and validity and can be a useful tool in clinical trials and other research.

Although fatigue is an unpleasant symptom commonly experienced by pediatric oncology patients, it also tends to be under-recognized and under-treated. A conceptual understanding of how patients perceive fatigue is beneficial for better identification and treatment planning. The purpose of this study was to understand how adolescents with cancer perceive their fatigue and to explore potential factors influencing their perceptions by using Q-methodology. The sample included 15 patients (ages 12-18 years) from the Chicago metropolitan area who were receiving cancer treatment. All participants completed a 37-statement Q-sort task. Data were analyzed by using PQMethod computer software. Results identified three descriptors of perceived fatigues reported by adolescents: energy and related capacity for physical functioning, psychosocial effects, and anemia-specific concerns. Appropriate referral for patients with the latter two descriptors of fatigue was recommended.

Background: Fatigue is the most common unrelieved symptom experienced by people with cancer. The purpose of this study was to examine whether cancer-related fatigue (CRF) can be summarized using a single score, that is, whether CRF is sufficiently unidimensional for measurement approaches that require or assume unidimensionality. We evaluated this question using factor analysis techniques including the theory-driven bi-factor model., Methods: Five hundred and fifty five cancer patients from the Chicago metropolitan area completed a 72-item fatigue item bank, covering a range of fatigue-related concerns including intensity, frequency and interference with physical, mental, and social activities. Dimensionality was assessed using exploratory and confirmatory factor analysis (CFA) techniques., Results: Exploratory factor analysis (EFA) techniques identified from 1 to 17 factors. The bi-factor model suggested that CRF was sufficiently unidimensional., Conclusions: CRF can be considered sufficiently unidimensional for applications that require unidimensionality. One such application, item response theory (IRT), will facilitate the development of short-form and computer-adaptive testing. This may further enable practical and accurate clinical assessment of CRF.

Objective: Cancer-related fatigue (CRF) is one of the most common unrelieved symptoms experienced by patients. CRF is underrecognized and undertreated due to a lack of clinically sensitive instruments that integrate easily into clinics. Modern computerized adaptive testing (CAT) can overcome these obstacles by enabling precise assessment of fatigue without requiring the administration of a large number of questions. A working item bank is essential for development of a CAT platform. The present report describes the building of an operational item bank for use in clinical settings with the ultimate goal of improving CRF identification and treatment., Study Design and Setting: The sample included 301 cancer patients. Psychometric properties of items were examined by using Rasch analysis, an Item Response Theory (IRT) model., Results and Conclusion: The final bank includes 72 items. These 72 unidimensional items explained 57.5% of the variance, based on factor analysis results. Excellent internal consistency (alpha=0.99) and acceptable item-total correlation were found (range: 0.51-0.85). The 72 items covered a reasonable range of the fatigue continuum. No significant ceiling effects, floor effects, or gaps were found. A sample short form was created for demonstration purposes. The resulting bank is amenable to the development of a CAT platform.

Fatigue is a common symptom among cancer patients and the general population. Due to its subjective nature, fatigue has been difficult to effectively and efficiently assess. Modern computerized adaptive testing (CAT) can enable precise assessment of fatigue using a small number of items from a fatigue item bank. CAT enables brief assessment by selecting questions from an item bank that provide the maximum amount of information given a person's previous responses. This article illustrates steps to prepare such an item bank, using 13 items from the Functional Assessment of Chronic Illness Therapy Fatigue Subscale (FACIT-F) as the basis. Samples included 1022 cancer patients and 1010 people from the general population. An Item Response Theory (IRT)-based rating scale model, a polytomous extension of the Rasch dichotomous model was utilized. Nine items demonstrating acceptable psychometric properties were selected and positioned on the fatigue continuum. The fatigue levels measured by these nine items along with their response categories covered 66.8% of the general population and 82.6% of the cancer patients. Although the operational CAT algorithms to handle polytomously scored items are still in progress, we illustrated how CAT may work by using nine core items to measure level of fatigue. Using this illustration, a fatigue measure comparable to its full-length 13-item scale administration was obtained using four items. The resulting item bank can serve as a core to which will be added a psychometrically sound and operational item bank covering the entire fatigue continuum.

Magnitude differences in scores on a measure of quality of life that correspond to differences in function or clinical course are called clinically important differences (CIDs). Anchor-based and distribution-based methods were used to provide ranges of CIDs for five targeted scale scores of the Functional Assessment of Cancer Therapy-Anemia (FACT-An) questionnaire. Three samples of cancer patients were used: Sample 1 included 50 patients participating in a validation study of the FACT-An; Sample 2 included 131 patients participating in a longitudinal study of chemotherapy-induced fatigue; sample 3 included 2,402 patients enrolled in a community-based clinical trial evaluating the effectiveness and safety of a treatment for anemia. Three clinical indicators (hemoglobin level; performance status; response to treatment) were used to determine anchor-based differences. One-half of the standard deviation and 1 standard error of measurement were used as distribution-based criteria. Analyses supported the following whole number estimates of a minimal CID for these five targeted scores: Fatigue Scale = 3.0; FACT-G total score = 4.0; FACT-An total score = 7.0; Trial Outcome Index-Fatigue = 5.0; and Trial Outcome Index-Anemia = 6.0. These estimates provide a basis for sample size estimation when planning for a clinical trial or other longitudinal study, when the purpose is to ensure detection of meaningful change over time. They can also be used in conjunction with more traditional clinical markers to assist investigators in determining treatment efficacy.

Background: Although fatigue is a common symptom among cancer patients, it is also a common experience in the general, healthy population. Its universality has made it difficult to appreciate whether the fatigue experienced by patients with cancer is distinguishable from the fatigue experienced by the general population. Because the etiology of fatigue is multifactorial, it also has been difficult to appreciate fully the relative contribution of anemia to cancer-related fatigue., Methods: To address this issue, responses to a brief, standardized set of 13 questions from the Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System were compared across three groups: anemic cancer patients (n = 2369 patients), nonanemic cancer patients (n = 113 patients), and the general United States population (n = 1010 persons)., Results: Fatigue scores of the anemic cancer patients (at both baseline and upon completion of anemia therapy) were significantly worse compared with the scores of nonanemic cancer patients that, in turn, were worse compared with the scores of the general United States population (P < 0.001). Score distributions were quite distinct for these three groups. Within the group of anemic cancer patients, the degree of anemia (mild, moderate, or severe) also was predictive of the degree of fatigue (P < 0.001), although the distributions were not dramatically distinct., Conclusions: Although anemia is clearly a factor that contributes to the severity of disease-related fatigue among cancer patients, hemoglobin levels explain only part of the difference compared with fatigue among the general United States population. The distinct distributions of fatigue scores of anemic cancer patients compared with the general United States population and the substantial sample sizes of these two groups enabled a discriminant analysis approach that allowed the differentiation of anemic cancer patients from the general population with high sensitivity (0.92) and reasonable specificity (0.69). Thus, although fatigue is a symptom most anyone can relate to, the fatigue of cancer patients, particularly those who are anemic, is decidedly worse. Interventions targeting this common and life-disrupting symptom likely would be of considerable value to patients with cancer.

Purpose: This paper reports on the development and psychometric properties of self-reported pediatric fatigue item banks as part of the Patient-Reported Outcomes Measurement Information System (PROMIS). Methods: Candidate items were developed by using PROMIS qualitative methodology. The resulting 39 items (25 tiredness related and 14 energy related) were field tested in a sample that included 3,048 participants aged 8–17 years. We used confirmatory factor analysis (CFA) to evaluate dimensionality and differential item functioning (DIF) analysis to evaluate parameter stability between genders and by age; we examined residual correlations to evaluate local dependence (LD) among items and estimated the parameters of item response theory (IRT) models. Results: Of 3,048 participants, 48 % were males, 60 % were white, and 23 % had at least one chronic condition. CFA results suggest two moderately correlated factors. Two items were removed due to high LD, and three due to gender-based DIF. Two item banks were calibrated separately using IRT: Tired and (Lack of) Energy, which consisted of 23 and 11 items, respectively; 10- and 8-item short-forms were created. Conclusion: The PROMIS assessment of self-reported fatigue in pediatrics includes two item banks: Tired and (Lack of) Energy. Both demonstrated satisfactory psychometric properties and can be used for research settings. [ABSTRACT FROM AUTHOR]