Biomedical subjects
Publications and source records attributed to David Cella.
We assessed the reliability, validity, and responsiveness to change of the 6-item Functional Assessment of Cancer Therapy-Breast Symptom Index (FBSI) in a sample of 615 metastatic breast cancer patients. The FBSI is a brief, clinically relevant, and psychometrically sound instrument that can be used to measure symptoms in patients with breast cancer.
OBJECTIVE: Our objective was to develop a pilot measure of subjective outcomes of complementary and alternative medicine (CAM). Current options for assessing subjective outcomes in CAM are either too burdensome or fail to represent diverse outcomes. A single measure specifying common, patient-reported outcomes of CAM would be of value. DESIGN: We conducted a three-phase instrument development study. In phase I, 30 CAM-receiving patients and 12 CAM practitioners completed a battery of standardized measures. Participants identified those standardized items relevant to CAM outcome and suggested additional outcome issues. In phase II, 20 CAM-receiving patients completed a Q-sort to determine which items from phase I were most relevant to CAM outcome. In phase III, five experts reviewed the items from phase II for content validity. SETTING: An integrative medicine clinic at a private, Midwest US hospital. PARTICIPANTS: CAM patients, practitioners, and researchers and an outcomes measurement specialist. RESULTS: In phase I, 30 standardized items were judged relevant to CAM outcome, and 8 additional items were suggested. In phase II, 29 of the 38 phase I items were deemed at least "moderately relevant" to CAM outcome. In phase III, experts added 15 items, dropped 9 items, and altered 3 items. The 35 resulting items were classified into content domains, forming a testable, pilot version of the instrument.
This article discusses quality of life in lung cancer: the validity and cross-cultural applicability of the Functional Assessment of Cancer Therapy-Lung scale.
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.
Cancer-related pain is often under-recognized and undertreated. This is partly due to the lack of appropriate assessments, which need to be comprehensive and precise yet easily integrated into clinics. Computerized adaptive testing (CAT) can enable precise-yet-brief assessments by only selecting the most informative items from a calibrated item bank. The purpose of this study was to create such a bank. The sample included 400 cancer patients who were asked to complete 61 pain-related items. Data were analyzed using factor analysis and the Rasch model. The final bank consisted of 43 items which satisfied the measurement requirement of factor analysis and the Rasch model, demonstrated high internal consistency and reasonable item-total correlations, and discriminated patients with differing degrees of pain. We conclude that this bank demonstrates good psychometric properties, is sensitive to pain reported by patients, and can be used as the foundation for a CAT pain-testing platform for use in clinical practice.
OBJECTIVES: To assess the reliability and validity of the Functional Assessment of Cancer Therapy-Vulvar (FACT-V). METHODS: Seventy-seven patients treated between January 1996 and January 2001 for cancer of the vulva completed the FACT-V, the Eastern Cooperative Oncology Group Performance Status Rating (ECOG-PSR) and the Hospital Anxiety and Depression Scale (HADS) once, 20 consecutive patients treated between February 2001 and October 2001 completed the questionnaires twice, once before surgery and at 2 months follow-up. The FACT-V scores were compared by patients' performance status, FIGO stage, recurrence, and age, and correlated to the HADS scores. Changes in the FACT-V from baseline to 2 months follow-up were evaluated to establish FACT-V's responsiveness to change. RESULTS: The FACT-V's internal consistency was adequate (Chronbach's alpha range, 0.75 to 0.92). Patients with lower performance status, higher FIGO-stage or recurrent disease received lower FACT-V scores, indicating discriminant validity. The correlation between the FACT-V and the HADS were in the expected direction, indicating convergent and divergent validity. From pre- to post-surgery, scores in nine out of fifteen items of the vulvar cancer-specific subscale improved, while those of five items declined, indicating sensitivity of the vulvar cancer specific items to changes in patients' well-being. CONCLUSIONS: The newly developed FACT-V provides a reliable and valid assessment of the quality of life of women with vulvar cancer. It can be used as a short measure of quality of life within research studies, and to facilitate communication about quality of life issues in clinical practice.
Although women diagnosed with cancer during their childbearing years are at significant risk for infertility, we know little about the relationship between infertility and long-term quality of life (QOL). To examine these relationships, we assessed psychosocial and reproductive concerns and QOL in 231 female cancer survivors. Greater reproductive concerns were significantly associated with lower QOL on numerous dimensions (P<.001). In a multiple regression model, social support, gynecologic problems, and reproductive concerns accounted for 63% of the variance in QOL scores. Women who reported wanting to conceive after cancer, but were not able to, reported significantly more reproductive concerns than those who were able to reproduce after cancer (P<.001). These preliminary data suggest that at least for vulnerable subgroups, the issue of reproductive concerns is worthy of additional investigation to assist cancer survivors living with the threat or reality of infertility.
To measure the effects of atopic dermatitis (AD) on the quality of life of affected young children and their families, we developed a prototype 62-item instrument, the Childhood Atopic Dermatitis Impact Scale (CADIS). The prototype CADIS was developed from a comprehensive conceptual framework based on data from parents and clinicians. The instrument had eight subscales (four each for child and parent): physical health, emotional health, physical functioning, and social functioning. The goal of this work was to test the validity of and to refine the prototype of CADIS. Two hundred seventy parents of children under the age of 6 y with AD responded to the instrument. Content validity was demonstrated by expert and parent reviews of the drafted and refined instrument, and by analyzing parents' responses to open-ended questions about their children's skin disease. Construct validity was assessed in exploratory factor analyses which supported a refinement in the conceptual framework to consist of two dimensions with five domains: child dimensions (symptoms and activity limitation/behavior), and parent dimensions (family/social function, sleep, and emotions). Seventeen items were eliminated, yielding a 45-item refined version of CADIS (score 0-180) with evidence of content and construct validity and suggested use in clinical research.
We illustrate a method for understanding the extent to which a pool of fairly diverse health status questions can be examined for their dimensionality, by first fitting the data to a unidimensional measurement model, then examining item fit and residual factor analysis to determine the pattern of deviations from unidimensionality. We simultaneously administered five questionnaires to 1,714 people with cancer and HIV disease and combined all responses into one analysis. Item responses were cocalibrated onto one presumed underlying construct, often referred to as health-related quality of life (HRQOL). To identify significant, higher order substructures in the data, we then conducted a factor analysis of the data residuals, revealing two definable higher order dimensions: physical well-being and mental well-being. These results agree with other research and provide direction for further studies defining these dimensions within an item response theory (IRT) tradition.
Assessing bowel function (BF) in prostate cancer can help determine therapeutic trade-offs. We determined the components of BF commonly assessed in prostate cancer studies as an initial step in creating an item bank for clinical and research application. We analyzed six archived data sets representing 4,246 men with prostate cancer. Thirty-one items from validated instruments were available for analysis. Items were classified into domains (diarrhea, rectal urgency, pain, bleeding, bother/distress, and other) then subjected to conventional psychometric and item response theory (IRT) analyses. Items fit the IRT model if the ratio between observed and expected item variance was between 0.60 and 1.40. Four of 31 items had inadequate fit in at least one analysis. Poorly fitting items included bleeding (2), rectal urgency (1), and bother/distress (1). A fifth item assessing hemorrhoids was poorly correlated with other items. Our analyses supported four related components of BF: diarrhea, rectal urgency, pain, and bother/distress.
Given the number of new cancer cases diagnosed each year and the increases in survival rates, the importance of having a clinically useful health-related quality of life (HRQOL) instrument has increased. The Functional Assessment of Cancer Therapy-General (FACT-G) is one such instrument that has been used worldwide to assess HRQOL. Previously, the use of the FACT-G had been limited because of a lack of published normative data. Normative data are useful for consumers to place their results in an appropriate context by comparing their scores of individuals or group of individuals to a reference group. Here, we present normative data for the FACT-G for two reference groups: (a) a sample of the general U.S. adult population and (b) a large, heterogeneous sample of adult patients with cancer. In addition, we demonstrate various uses of the normative data.
The FACIT (Functional Assessment of Chronic Illness Therapy) translation methodology has been in use for nearly 10 years and, during the course of that time, has emphasized a universal translation approach that includes multicountry review, the use of qualitative and quantitative methods in testing, and the exploration of new methods such as differential item functioning (DIF) analysis using item response theory to evaluate item equivalence. The FACIT translation methodology aims to establish equivalence of meaning and measurement between different country versions through the use of the decentered model of translation and advanced statistical methods.
To make meaningful cross-cultural comparisons of health-related quality of life (HRQOL) or to pool international research data, it is essential to create culturally unbiased measures that detect clinically important differences between patients. We evaluated the measurement properties of the Functional Assessment of Cancer Therapy-Breast (FACT-B) in 111 Austrian and 144 U.S. patients with breast cancer using item response theory (IRT) methods. A small number of items were identified as displaying statistically significant differential item functioning (DIF), suggesting possible measurement bias. The majority of the items functioned similarly between the two cultural groups. U.S. patients reported lower (worse) physical function and well-being compared with Austrian patients, higher (better) social/family well-being and similar emotional well-being, before and after adjustment for DIF. IRT and related measurement models provide useful methods for assessing cross-cultural equivalence and determining which items can be pooled across languages before analyzing HRQOL data. Determination of clinically significant cross-cultural differences will require additional investigation.
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OBJECTIVE: This study validated a brief measure of fatigue in rheumatoid arthritis (RA), the Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale. METHODS: The FACIT Fatigue was tested along with measures previously validated in RA: the Multidimensional Assessment of Fatigue (MAF) and Medical Outcomes Study Short-Form 36 (SF-36) Vitality. The sample included 636 patients with RA enrolled in a 24 week double blind, randomized clinical trial (RCT) of adalimumab versus placebo. RESULTS: The FACIT Fatigue showed good internal consistency (alpha = 0.86 to 0.87), strong association with SF-36 Vitality (r = 0.73 to 0.84) and MAF (r = -0.84 to -0.88), and the ability to differentiate patients according to clinical change using the American College of Rheumatology (ACR) response criteria (ACR 20/50/70). Psychometric performance of the FACIT Fatigue scale was comparable to that of the other 2 fatigue measures. A minimally important difference in FACIT Fatigue change score of 3-4 points was confirmed in a separate sample of 271 patients with RA enrolled in a second double blind RCT of adalimumab versus placebo. CONCLUSION: The FACIT Fatigue is a brief, valid measure for monitoring this important symptom and its effects on patients with RA.
While there has not been a dramatic improvement in the cure rate of ovarian cancer, >40% of women survive longer than 5 years, with what is commonly considered a "chronic" cancer. In each phase of the illness (diagnosis, surgery and chemotherapy with curative intent, remission and survivorship, relapse and sequential chemotherapy, bowel obstruction and end of life), quality of life (QOL) is one of the most important considerations. There has recently been a large increase in studies reporting the assessment of QOL; that has changed the field from descriptive reporting to quantitative science. There are well-validated, standardized scales, and approximately 10% of randomized cancer trials include health-related QOL as one of the main end points. This article reviews the history and development of QOL evaluation and the 2 main approaches to QOL assessment (psychometric based and utility based) and describes strategies for meaningful interpretation of QOL profiles. While the humanities perhaps teach us much about the value of QOL, the science of the study of QOL will be the foundation and confirmation of many of the anticipated advances for patients.
PURPOSE: To determine the quality of life (QoL) of women participating in the Arimidex, Tamoxifen, Alone or in Combination (ATAC) Adjuvant Breast Cancer Trial during the first 2 years of treatment. PATIENTS AND METHODS: A total of 1,021 women were enrolled onto the QoL subprotocol. All had completed primary treatment (surgery +/- radiotherapy +/- chemotherapy) and were to receive 5 years of adjuvant treatment with anastrozole (n = 335), tamoxifen (n = 347), or a combination (n = 339) of both. Patients completed the Functional Assessment of Cancer Therapy-Breast (FACT-B) plus endocrine subscale (ES) at baseline and 3, 6, 12, 18, and 24 months, or until disease recurrence. The primary end point was the FACT-B Trial Outcome Index (TOI). The secondary end point was the ES total score. Analyses of individual endocrine symptoms were also explored. RESULTS: Questionnaire completion approximated 85% of assessments available for analysis. Overall QoL for all groups improved from baseline during the 2-year period. There were no significant differences in TOI or ES scores across treatment groups. Endocrine symptoms increased between baseline and 3 months for all groups and stabilized thereafter. There were some small differences in side effect profiles. Compared with patients receiving tamoxifen only, patients receiving anastrozole only reported significantly fewer cold sweats and vaginal discharge, yet more vaginal dryness, painful intercourse, and loss of sexual interest. CONCLUSION: Two years of treatment with anastrozole, tamoxifen, or the combination had a similar overall QoL impact, showing gradual improvement over time. Endocrine-related symptoms for all three arms worsened initially and recovered partially during 2 years. The different symptoms experienced may assist in decision making about treatment and supportive care needs.
PURPOSE: To determine whether cisplatin plus paclitaxel (C+P) improved response rate, progression-free survival (PFS), or survival compared with cisplatin alone in patients with stage IVB, recurrent, or persistent squamous cell carcinoma of the cervix. PATIENTS AND METHODS Eligible: patients with measurable disease, performance status (PS) 0 to 2, and adequate hematologic, hepatic, and renal function received either cisplatin 50 mg/m2 or C+P (cisplatin 50 mg/m2 plus paclitaxel 135 mg/m2) every 3 weeks for six cycles. Tumor measurements and quality-of-life (QOL) assessments were obtained before each treatment cycle. RESULTS: Of 280 patients entered, 6% were ineligible. Among 264 eligible patients, 134 received cisplatin and 130 received C+P. Groups were well matched with respect to age, ethnicity, PS, tumor grade, disease site, and number of cycles received. The majority of all patients had prior radiation therapy (cisplatin, 92%; C+P, 91%). Objective responses occurred in 19% (6% complete plus 13% partial) of patients receiving cisplatin versus 36% (15% complete plus 21% partial) receiving C+P (P = .002). The median PFS was 2.8 and 4.8 months, respectively, for cisplatin versus C+P (P < .001). There was no difference in median survival (8.8 months v 9.7 months). Grade 3 to 4 anemia and neutropenia were more common in the combination arm. There was no significant difference in QOL scores, although a disproportionate number of patients (cisplatin, n = 50; C+P, n = 33) dropped out of the QOL component, presumably because of increasing disease, deteriorating health status, or early death. CONCLUSION C+P is superior to cisplatin alone with respect to response rate and PFS with sustained QOL.