The Functional Assessment of Cancer Therapy Scale: Development and Validation of the General Measure.

PURPOSE: We developed and validated a brief, yet sensitive, 33-item general cancer quality-of-life (QL) measure for evaluating patients receiving cancer treatment, called the Functional Assessment of Cancer Therapy (FACT) scale. METHODS AND RESULTS: The five-phase validation process involved 854 patients with cancer and 15 oncology specialists. The initial pool of 370 overlapping items for breast, lung, and colorectal cancer was generated by open-ended interview with patients experienced with the symptoms of cancer and oncology professionals. Using preselected criteria, items were reduced to a 38-item general version. Factor and scaling analyses of these 38 items on 545 patients with mixed cancer diagnoses resulted in the 28-item FACT-general (FACT-G, version 2). In addition to a total score, this version produces subscale scores for physical, functional, social, and emotional well-being, as well as satisfaction with the treatment relationship. Coefficients of reliability and validity were uniformly high. The scale's ability to discriminate patients on the basis of stage of disease, performance status rating (PSR), and hospitalization status supports its sensitivity. It has also demonstrated sensitivity to change over time. Finally, the validity of measuring separate areas, or dimensions, of QL was supported by the differential responsiveness of subscales when applied to groups known to differ along the dimensions of physical, functional, social, and emotional well-being. CONCLUSION: The FACT-G meets or exceeds all requirements for use in oncology clinical trials, including ease of administration, brevity, reliability, validity, and responsiveness to clinical change. Selecting it for a clinical trial adds the capability to assess the relative weight of various aspects of QL from the patient's perspective.

Validation of the NIH Toolbox in Individuals with Neurologic Disorders.

OBJECTIVE: Individuals with spinal cord injury (SCI), traumatic brain injury (TBI), and stroke experience a variety of neurologically related deficits across multiple domains of function. The NIH Toolbox for the Assessment of Neurological and Behavioral Function (NIHTB) examines motor, sensation, cognition, and emotional functioning. The purpose of this paper is to establish the validity of the NIHTB in individuals with neurologic conditions. METHODS: Community-dwelling individuals with SCI (n = 209), TBI (n = 184), or stroke (n = 211) completed the NIHTB. Relative risks for impaired performance were examined relative to a matched control groups. RESULTS: The largest group differences were observed on the Motor domain and for the Fluid Cognition measures. All groups were at increased risk for motor impairment relative to normative standards and matched controls. Fluid cognitive abilities varied across groups such that individuals with stroke and TBI performed more poorly than individuals with SCI; increased relative risks for impaired fluid cognition were seen for individuals in the stroke and TBI groups, but not for those in the SCI group. All three neurologic groups performed normally on most measures in the Sensation Battery, although TBI participants evidenced increased risk for impaired odor identification and the stroke group showed more vision difficulties. On the Emotion Battery, participants in all three groups showed comparably poor psychological well-being, social satisfaction, and self-efficacy, whereas the TBI group also evidenced slightly increased negative affect. CONCLUSIONS: Data provide support for the validity of the NIHTB in individuals with neurologic conditions.

Validation and clinical utility of the executive function performance test in persons with traumatic brain injury.

This study examined the relationships between the Executive Function Performance Test (EFPT), the NIH Toolbox Cognitive Function tests, and neuropsychological executive function measures in 182 persons with traumatic brain injury (TBI) and 46 controls to evaluate construct, discriminant, and predictive validity. Construct validity: There were moderate correlations between the EFPT and the NIH Toolbox Crystallized (r = -.479), Fluid Tests (r = -.420), and Total Composite Scores (r = -.496). Discriminant validity: Significant differences were found in the EFPT total and sequence scores across control, complicated mild/moderate, and severe TBI groups. We found differences in the organisation score between control and severe, and between mild and severe TBI groups. Both TBI groups had significantly lower scores in safety and judgement than controls. Compared to the controls, the severe TBI group demonstrated significantly lower performance on all instrumental activities of daily living (IADL) tasks. Compared to the mild TBI group, the controls performed better on the medication task, the severe TBI group performed worse in the cooking and telephone tasks. Predictive validity: The EFPT predicted the self-perception of independence measured by the TBI-QOL (beta = -0.49, p < .001) for the severe TBI group. Overall, these data support the validity of the EFPT for use in individuals with TBI.

Family caregivers of individuals with spinal cord injury: exploring the stresses and benefits.

STUDY DESIGN: Cross-sectional, focus group. OBJECTIVES: To explore positive and negative issues reported by family caregivers of people with spinal cord injury (SCI) to develop a relevant and valid tool to assess caregiver distress and benefit for this unique population. METHODS: Seventy-three family caregivers of people with SCI participated in 16 focus groups. We audio-recorded all focus group discussions and transcribed the recordings verbatim. Qualitative analysis of the transcripts was performed to identify major themes and subthemes relating to family caregiving activities. RESULTS: Positive themes were disproportionately limited in comparison with negative themes. Positives included changes in self-awareness, enhanced family cohesiveness and feeling appreciated. Negative themes included physical and emotional strain, dissatisfaction with hired carers and strain on family relationships. Health-related themes included fatigue and lack of sleep. Caregivers identified sources of strength that helped them manage stresses including faith and support from friends and co-workers. CONCLUSION: The numerous themes help lay the groundwork to develop a valid and reliable assessment tool to assist health-care providers in treatment planning and the provision of long-term assistance to people with SCI by enhancing areas of strengths and addressing factors that contribute to burden and distress for family caregivers.

Developing a contemporary functional outcome measure for spinal cord injury research.

STUDY DESIGN: This study used qualitative analysis of focus group discussions. OBJECTIVE: The primary objective was to select functional activities to include in an item pool, which is the first step in developing a spinal cord injury computer adaptive test (SCI-CAT). SETTING: This multisite study was conducted at six US National Spinal Cord Injury Model Systems Programs. METHODS: Focus group discussions, which included persons with tetraplegia and paraplegia and clinicians, were conducted. Transcripts were analyzed using a grounded theory approach. Functional activities were identified, binned, winnowed, written as functional items, and cognitively tested. RESULTS: Focus group discussion analysis identified 326 functional activity items that fit into categories outlined in the International Classification of Functioning, Disability and Health (ICF) framework: Mobility (193 items), including assessment of functioning in a manual (44 items) and power wheelchair (19 items); self-care (109 items); and communication (19 items). Items related to sexual function were also identified (5 items). CONCLUSION: The SCI-CAT item pool includes items that assess functional activities important to persons with SCI. Items cover a wide range of functional ability and reflect most ICF categories. The SCI-CAT pool is currently being field tested to develop a calibrated item bank. Further development will yield a CAT of functional activities appropriate for SCI research.

Outcome measures in spinal cord injury: recent assessments and recommendations for future directions.

STUDY DESIGN: Review by the spinal cord outcomes partnership endeavor (SCOPE), which is a broad-based international consortium of scientists and clinical researchers representing academic institutions, industry, government agencies, not-for-profit organizations and foundations. OBJECTIVES: Assessment of current and evolving tools for evaluating human spinal cord injury (SCI) outcomes for both clinical diagnosis and clinical research studies. METHODS: a framework for the appraisal of evidence of metric properties was used to examine outcome tools or tests for accuracy, sensitivity, reliability and validity for human SCI. RESULTS: Imaging, neurological, functional, autonomic, sexual health, bladder/bowel, pain and psychosocial tools were evaluated. Several specific tools for human SCI studies have or are being developed to allow the more accurate determination for a clinically meaningful benefit (improvement in functional outcome or quality of life) being achieved as a result of a therapeutic intervention. CONCLUSION: Significant progress has been made, but further validation studies are required to identify the most appropriate tools for specific targets in a human SCI study or clinical trial.

WAIS-III reliability data for clinical groups.

Reliability estimates for psychological tests are almost always reported for nonclinical populations (e.g., the normative samples). Such practice will no longer be sufficient as the new standards for testing call for an adequate assessment of psychometric properties within the specific population being tested. The purpose of this study was to provide internal consistency reliability estimates for clinical groups on the Wechsler Adult Intelligence Scale-Third Edition. The study included data from 403 clinical participants composed of 10 groups of adults recruited as part of the WAIS-III clinical validity studies. Split-half reliability coefficients were obtained for these groups replicating the procedure used in the WAIS-III. With 8 of the clinical groups, the split-half reliability coefficients were comparable to, or even higher than, those reported for the WAIS-III standardization sample. In general, the split-half coefficients for the Verbal subtests tended to be higher than the coefficients for the Performance subtests. The high magnitude and general pattern of these coefficients demonstrate that the WAIS-III scales do not include additional error variance above and beyond what is reported in the WAIS-III-WMS-III Technical Manual when it was used to assess certain clinical groups. For the ADHD/ADD and learning disabilities groups, however, the internal consistencies coefficients of some subtests were relatively lower, although not statistically significant, than the normative sample. These findings may reflect more heterogeneity within the groups. The implications for assessment and for using alternate methods of determining the psychometric properties in these populations are discussed.

The influence of IQ stratification on WAIS-III/WMS-III FSIQ-general memory index discrepancy base-rates in the standardization sample.

Since memory performance expectations may be IQ-based, unidirectional base rate data for IQ-Memory Score discrepancies are provided in the WAIS-III/WMS-III Technical Manual. The utility of these data partially rests on the assumption that discrepancy base rates do not vary across ability levels. FSIQ stratified base rate data generated from the standardization sample, however, demonstrate substantial variability across the IQ spectrum. A superiority of memory score over FSIQ is typical at lower IQ levels, whereas the converse is true at higher IQ levels. These data indicate that the use of IQ-memory score unstratified "simple difference" tables could lead to erroneous conclusions for clients with low or high IQ. IQ stratified standardization base rate data are provided as a complement to the "predicted difference" method detailed in the Technical Manual.

Criterion validity of new WAIS-II subtest scores after traumatic brain injury.

The criterion validity of the new subtests from the Wechsler Adult Intelligence Scale-Third Edition (WAIS-III; Wechsler, 1997) was evaluated in a sample of 100 patients with traumatic brain injury (TBI). Letter-Number Sequencing and Symbol Search, but not Matrix Reasoning, yielded statistically significant differences in performance between patients with moderate-severe TBI, patients with mild TBI, and demographically matched controls. Level of education accounted for a statistically significant amount of variance in the performance of patients with TBI, in addition to that explained by injury severity variables. It is concluded that Letter-Number Sequencing and Symbol Search have satisfactory criterion validity, but that they need to be supplemented with other measures in the context of neuropsychological evaluations. Matrix Reasoning, on the other hand, is not sensitive to the sequelae of TBI and more studies are needed to determine how it can be used for neuropsychological assessment purposes.

Development of a general ability index for the Wechsler Adult Intelligence Scale--Third Edition.

The Wechsler Adult Intelligence Scale--Third Edition (WAIS-III; D. Wechsler, 1997) permits the calculation of both traditional IQ and index scores. However, if only the subtests constituting the index scores are administered, especially those yielding the Verbal Comprehension and Perceptual Organization Indexes, there is no equivalent measure of Full Scale IQ. Following the procedure for calculating a General Ability Index (GAI; A. Prifitera, L. G. Weiss, & D. H. Saklofske, 1998) for the Wechsler Intelligence Scale for Children--Third Edition (D. Wechsler, 1991), GAI normative tables for the WAIS-III standardization sample are reported here.

WAIS-III and WMS-III profiles of mildly to severely brain-injured patients.

Wechsler Adult Intelligence Scale-III (WAIS-III) and Wechsler Memory Scale-III (WMS-III; The Psychological Corporation, 1997) scores of patients with mild traumatic brain injury (MTBI, n = 23) to moderate-severe traumatic brain injury (M-S TBI, n = 22) were compared to those of 45 matched normal control patients. WAIS-III results revealed that IQ and index scores of MTBI patients did not significantly differ from those of controls, whereas M-S TBI patients received significantly lower mean scores on all measures. All M-S TBI patients' WMS-III index scores also revealed significantly lower scores in comparison to those of control participants, with the exception of Delayed Auditory Recognition. MTBI patients showed significantly lower mean index scores compared to normal controls on measures of immediate and delayed auditory memory, immediate memory, visual delayed memory, and general memory. Eta-squared analyses revealed that WMS-III visual indexes and WAIS-III processing speed showed particularly large effect sizes. These results suggest that symptomatic MTBI patients obtain some low WMS-III test scores comparable to those of more severely injured patients.

Two-tailed versus one-tailed base rates of discrepancy scores in the WAIS-III.

Tables included in the WAIS-III report the frequency of discrepancies between IQ and index scores independent of the directionality of the score. If an examiner does not have any a priori hypothesis about which skill may be more developed and which skills may be weaknesses, it is appropriate to use these tables as they are. In this case the examiner would be looking for unusually large discrepancies between scores irrespective of direction. When an examiner has a hypothesis about which skills may be weaknesses and strengths for an individual, the frequencies that are based upon an absolute value of the discrepancy will cause examiners to overestimate the frequency of the occurrence of the discrepancy score in question. Sattler and Ryan (1998) and Tulsky, Zhu, and Vasquez (1998) suggested dividing the frequencies reported in the WAIS-III tables in half to obtain the correct base rate. This suggestion is tested in this paper. New observed frequency tables were derived from the WAIS-III and WMS-III standardization samples and these frequencies were compared against the estimated frequencies using the method described by Sattler and Ryan (1998) and Tulsky et al. (1998). The differences between these two methods were calculated and are, for the most part, insignificant. In light of the similarity between the methods, the implications of using observed frequencies versus estimated frequencies is discussed.

Co-norming the WAIS-III and WMS-III: Is there a test-order effect on IQ and memory scores?

Test-order effect on the WAIS-III and WMS-III scores was evaluated using the WMS-III standardization sample. Participants completed the standardization editions of the WAIS-III and WMS-III in one session, with the tests administered in roughly counterbalanced order. Repeated measure MANOVA analyses were conducted to determine if there was an overall test-order effect for subtest, index, or IQ scores. No significant test-order effects were found for either the WAIS-III index or IQ scores or for the WMS-III index scores. At the subtest level, the majority of the WAIS-III and WMS-III subtests did not show a significant test-order effect. The exceptions were Digit Span and Digit Symbol-Coding on the WAIS-III and Faces II and Logical Memory II on the WMS-III. Although statistically significant test-order effects were found on these subtests, the effect sizes were small. This study indicates that the test-order effect is not a potential threat to the internal validity of the WAIS-III and WMS-III normative data. The practical implications of the current study are discussed.

Could test length or order affect scores on letter number sequencing of the WAIS-III and WMS-III? Ruling out effects of fatigue.

The Letter Number Sequencing subtest of the WAIS-III and WMS-III was administered at the end of the standardization edition of the WMS-III. It was not administered as part of the WAIS-III standardization battery. Nevertheless, the subtest was included in the published version of the WAIS-III. This study examines differences between examinees administered the Letter Number Sequencing subtest at three different times during a psychological battery: (1) as part of the published battery, (2) as part of the WMS-III when the WMS-III was administered as the first test in a sequence, and (3) as part of the WMS-III standardization when the WAIS-III was administered immediately preceding the WMS-III. The participants were 372 examinees ( n = 124 in each condition) who were matched on key demographic variables. A repeated measures MANOVA yielded no difference in subtest scores when administered in any of these conditions. The results show no evidence of fatigue or ordering effects on the Letter Number Sequencing subtest.

Reliability and validity of the Functional Assessment of Cancer Therapy-Colorectal (FACT-C) quality of life instrument.

BACKGROUND: This paper describes the development of the Functional Assessment of Cancer Therapy-Colorectal (FACT-C)--a questionnaire assessing quality of life concerns pertinent to colorectal cancer patients. This self-report instrument combines specific concerns related to colorectal cancer with concerns that are common to all cancer patients as assessed with the FACT-General (FACT-G). METHOD: Three separate and distinct validation samples were used with different ethnic and stage of disease compositions. RESULTS: Results suggest that the FACT-C is a reliable and valid measure in both its English and Spanish language versions. Specifically, the FACT-C evidenced good internal consistency reliability and concurrent validity, as well as an ability to distinguish between groups based on functional status and extent of disease. The FACT-C was also found to be sensitive to changes in functional status. Colorectal cancer-specific items form the Colorectal Cancer Subscale (CCS) which was found to have adequate convergent and divergent validity. Internal consistency was adequate in most samples. In addition, the CCS was able to distinguish among groups that differed in functional status and was sensitive to change in functional status. CONCLUSION: It is recommended that the entire FACT-C (rather than simply the CCS) be used when studying patients with colorectal cancer in order to provide a comprehensive assessment of quality of life. Recommendations are offered concerning the appropriate use of these measures in clinical research and directions for future research with colorectal cancer patients.

Reliability and validity of the Functional Assessment of Cancer Therapy-Breast quality-of-life instrument.

PURPOSE: This is the first published report on the validation of the Functional Assessment of Cancer Therapy-Breast (FACT-B), a 44-item self-report instrument designed to measure multidimensional quality of life (QL) in patients with breast cancer. The FACT-B consists of the FACT-General (FACT-G) plus the Breast Cancer Subscale (BCS), which complements the general scale with items specific to QL in breast cancer. The FACT-B was developed with an emphasis on patients' values and brevity and is available in nine languages. METHODS AND RESULTS: Two validation samples were used for this report. The first (n = 47) was tested twice over a 2-month period to assess sensitivity to change. Significant sensitivity to change in performance status rating (PSR) was demonstrated for the FACT-B total score, the Physical Well-Being (PWB) subscale, the Functional Well-Being (FWB) subscale, and the BCS. Sensitivity to change in QL as measured by the Functional Living Index-Cancer (FLIC) was documented in the FACT-B total score, PWB, FWB, and Emotional Well-Being (EWB). Additional validity and reliability data were obtained from a larger sample (n = 295). The alpha coefficient (internal consistency) for the FACT-B total score was high (alpha = .90), with subscale alpha coefficients ranging from .63 to .86. Evidence supported test-retest reliability, as well as convergent, divergent, and known groups validity. CONCLUSION: The FACT-B is appropriate for use in oncology clinical trials, as well as in clinical practice. It demonstrates ease of administration, brevity, reliability, validity, and sensitivity to change.

Reliability and validity of the Functional Assessment of Cancer Therapy-Lung (FACT-L) quality of life instrument.

The FACT-L (version 3) is a 44-item self-report instrument which measures multidimensional quality of life. Available in eight languages, it is currently being used in several Phase II and III lung cancer clinical trials. Reliability and validity of the 33-item version 2 of the FACT-General (FACT-G) have previously been published. This paper reports further validation data on the FACT-G with a subsample of lung cancer patients from the original publication and, more importantly, presents data on the Lung Cancer Subscale (LCS). The nine LCS questions were administered along with the FACT-G to 116 patients with lung cancer. Internal consistency (coefficient alpha) was improved from 0.53 to 0.68 by dropping two questions which were uncorrelated with the others. A subset of 41 patients was tested again at 2 months to evaluate sensitivity to change in performance status rating (PSR) and to obtain estimates of a clinically meaningful change score for the FACT-G and the 7-item LCS. Using a linear test for trend, sensitivity to change in performance status rating (PSR) was obtained with the Total score (P = 0.03), the Physical Well Being (PWB) subscale (P = 0.02), the Functional Well Being (FWB) subscale (P = 0.05), and the LCS (P = 0.03). A 21-item Trial Outcome Index (TOI), combining scores on PWB, FWB and LCS, was highly reliable (coefficient a = 0.89) and sensitive to change in PSR F(1,38) = 4.84 (P = 0.01). This TOI is probably the most relevant and precise indicator of patient-reported quality of life available for lung cancer patients who complete the FACT-L while participating in an oncology clinical trial. The FACT-L may also be of benefit in evaluating quality of life in patients with lung diseases other than cancer.

The Functional Assessment of Cancer Therapy scale: development and validation of the general measure.

PURPOSE: We developed and validated a brief, yet sensitive, 33-item general cancer quality-of-life (QL) measure for evaluating patients receiving cancer treatment, called the Functional Assessment of Cancer Therapy (FACT) scale. METHODS AND RESULTS: The five-phase validation process involved 854 patients with cancer and 15 oncology specialists. The initial pool of 370 overlapping items for breast, lung, and colorectal cancer was generated by open-ended interview with patients experienced with the symptoms of cancer and oncology professionals. Using preselected criteria, items were reduced to a 38-item general version. Factor and scaling analyses of these 38 items on 545 patients with mixed cancer diagnoses resulted in the 28-item FACT-general (FACT-G, version 2). In addition to a total score, this version produces subscale scores for physical, functional, social, and emotional well-being, as well as satisfaction with the treatment relationship. Coefficients of reliability and validity were uniformly high. The scale's ability to discriminate patients on the basis of stage of disease, performance status rating (PSR), and hospitalization status supports its sensitivity. It has also demonstrated sensitivity to change over time. Finally, the validity of measuring separate areas, or dimensions, of QL was supported by the differential responsiveness of subscales when applied to groups known to differ along the dimensions of physical, functional, social, and emotional well-being. CONCLUSION: The FACT-G meets or exceeds all requirements for use in oncology clinical trials, including ease of administration, brevity, reliability, validity, and responsiveness to clinical change. Selecting it for a clinical trial adds the capability to assess the relative weight of various aspects of QL from the patient's perspective.

Quality of life in cancer: definition, purpose, and method of measurement.

Over the past 20 years, changes within medicine and society have encouraged an expansion in conceptualizing and evaluating the goals and important outcomes of medical treatments. In evaluating the care of people with cancer and other chronic illnesses, a major part of the expansion has been the inclusion of means to assess the quality of life in addition to the quantity of life associated with various treatments. This paper presents a review of the current literature on quality-of-life assessment in oncology research and practice. The review is organized around current thinking about the definition of quality of life, the purpose of quality-of-life measurement, the method of assessment, and the competing advantages and disadvantages of disease-specific versus general health outcome measurement. Recommendations for proceeding with quality-of-life measurement in oncology are provided to encourage increased attention to the need to remain closely tied to a theoretical construct.