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Biomedical subjects

David Cella

Publications and source records attributed to David Cella.

At least 37 records · Page 2Linked to original sources
PubMed2006

Quality of life after iodine 125 brachytherapy vs enucleation for choroidal melanoma: 5-year results from the Collaborative Ocular Melanoma Study: COMS QOLS Report No. 3.

OBJECTIVE: To describe health- and vision-targeted quality of life following treatment with iodine 125 brachytherapy vs enucleation for choroidal melanoma in a subgroup of patients who were treated and observed prospectively as part of a large randomized clinical trial. MAIN OUTCOME MEASURES: Difficulty with driving, near vision activities, and activities using stereopsis or binocularity; anxiety; and depression. PARTICIPANTS: Two hundred nine patients who enrolled in the Collaborative Ocular Melanoma Study trial for medium-sized tumors between March 1995 and July 1998 and gave informed consent prior to randomization to participation in an ancillary study of quality of life. METHODS: Patients were interviewed by telephone by a trained interviewer from the Collaborative Ocular Melanoma Study Coordinating Center at baseline (prior to randomization), at 6 months, and on annual anniversaries of enrollment. The questionnaire battery included the Medical Outcomes Study Short Form 36, the Activities of Daily Vision Scale, the National Eye Institute Visual Function Questionnaire, and the Hospital Anxiety and Depression Scale. Additional questions concerning satisfaction with posttreatment appearance and concerns about cancer recurrence also were included in posttreatment interviews. RESULTS: There was a significant increase in both treatment groups in levels of reported difficulty for most vision-oriented activities, and in bodily and ocular pain, 6 months following treatment. Differences in visual function between treatment groups reported during follow-up were relatively small, but significant differences favoring brachytherapy-treated patients were observed for driving during the first year of follow-up and for peripheral vision during the first 2 years of follow-up. Anxiety levels in both groups decreased significantly following treatment, but patients treated with brachytherapy with symptoms of anxiety were less likely to report later resolution of symptoms than patients with symptoms of anxiety who were treated with enucleation. This study was unable to assess impact of treatment on satisfaction with appearance and concern about cancer recurrence during the first year after treatment, but no treatment-related differences were found on these measures at 2 years and later follow-up times. CONCLUSIONS: Patients treated with brachytherapy reported significantly better visual function than patients treated with enucleation with respect to driving and peripheral vision for up to 2 years following treatment. Differences between treatments in visual function diminished by 3 to 5 years posttreatment, paralleling decline in visual acuity in brachytherapy-treated eyes. Patients treated with brachytherapy were more likely to have symptoms of anxiety during follow-up than patients treated with enucleation. APPLICATION TO CLINICAL PRACTICE: Given that no significant differences in survival between enucleation and brachytherapy have been found, the differences demonstrated here for driving and anxiety will allow the individual patient and physician to make informed choices regarding treatment based on personal preferences.

Activities of Daily Living↗
PubMed2006

Giving meaning to measure: linking self-reported fatigue and function to performance of everyday activities.

Fatigue, a common symptom of cancer patients, particularly those on active treatment, is generally evaluated using self-report methods, yet it remains unclear how self-reported fatigue scores relate to performance of daily activities. This study examines the relationships among self-reported and performance-based measures of function in patients receiving chemotherapy (CT) to link self-reported fatigue measures to self-report and performance-based measures of function. Self-reported fatigue using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) and self-reported physical function using the physical function 10 subscale of the Short Form 36 (SF-36) (PF-10) were measured in 64 patients within 2 weeks of beginning CT (n=64) and after three cycles of CT (n=48). Motor and cognitive functions were captured using five self-reported and seven observed-performance measures at each time point. Significant correlations between self-reported and observed measures ranged from 0.30 to 0.71. Self-reported fatigue correlated (0.30-0.45) with performance-based function. FACIT-F scores in the range of 30 and below and PF-10 scores in the range of 50 and below were related to an increased difficulty performing everyday activities. Observed measures of physical performance correlate moderately with self-reported fatigue and self-reported physical function. These relationships enable one to begin linking fatigue scores directly to a person's ability to perform everyday activities.

Activities of Daily Living↗
PubMed2006

Measuring fatigue in Parkinson's disease: a psychometric study of two brief generic fatigue questionnaires.

This study evaluated and compared the measurement properties of the 13-item Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-F) and the 9-item Fatigue Severity Scale (FSS) in 118 consecutive Parkinson's disease (PD) patients, using traditional and Rasch measurement methodologies. Both questionnaires exhibited excellent data quality and reliability (coefficient alpha>or=0.9), and acceptable rating scale functionality, and both discriminated between fatigued and nonfatigued patients. Factor and Rasch analyses provided general support for unidimensionality of both FACIT-F and FSS, although they do not appear to measure identical aspects of fatigue. No signs of differential item functioning (DIF) were found for the FACIT-F, whereas potential age DIF was detected for two FSS items. These results support the measurement validity of both questionnaires in PD, although the FACIT-F displayed better measurement precision and modest psychometric advantages over the FSS. Availability of psychometrically sound fatigue measures that are applicable across disorders provides a sound basis for advancing the understanding of this common and distressing complaint.

Aged↗
PubMed2006

Quality of life considerations in gynecologic cancer. FIGO 26th Annual Report on the Results of Treatment in Gynecological Cancer.

Quality of life (QOL) is a fundamental consideration for patients with life threatening diseases. Major evolving paradigms are discussed: improved QOL with laparoscopic surgery, the impact on QOL of intraperitoneal chemotherapy for optimally cytoreduced ovarian cancer, combination therapy, sexuality, and survivorship. The goals of treatment for many patients with gynecologic tumors remain largely palliative, and patient reported QOL is the primary outcome determining the utility of treatment. Particularly in this area, QOL endpoints are increasingly important in clinical trials. The QOL issues facing gynecologic cancer patients, the use of validated QOL instruments, recent advances in the evaluation of interventions, and changes in concepts related to QOL are reviewed.

Adaptation, Psychological↗
PubMed2006

Item banks and their potential applications to health status assessment in diverse populations.

In the context of an ethnically diverse, aging society, attention is increasingly turning to health-related quality of life measurement to evaluate healthcare and treatment options for chronic diseases. When evaluating and treating symptoms and concerns such as fatigue, pain, or physical function, reliable and accurate assessment is a priority. Modern psychometric methods have enabled us to move from long, static tests that provide inefficient and often inaccurate assessment of individual patients, to computerized adaptive tests (CATs) that can precisely measure individuals on health domains of interest. These modern methods, collectively referred to as item response theory (IRT), can produce calibrated "item banks" from larger pools of questions. From these banks, CATs can be conducted on individuals to produce their scores on selected domains. Item banks allow for comparison of patients across different question sets because the patient's score is expressed on a common scale. Other advantages of using item banks include flexibility in terms of the degree of precision desired; interval measurement properties under most circumstances; realistic capability for accurate individual assessment over time (using CAT); and measurement equivalence across different patient populations. This work summarizes the process used in the creation and evaluation of item banks and reviews their potential contributions and limitations regarding outcome assessment and patient care, particularly when they are applied across people of different cultural backgrounds.

Aged↗
PubMed2006

Evaluating linguistic equivalence of patient-reported outcomes in a cancer clinical trial.

BACKGROUND: In order to make meaningful cross-cultural or cross-linguistic comparisons of health-related quality of life (HRQL) or to pool international research data, it is essential to create unbiased measures that can detect clinically important differences. When HRQL scores differ between cultural/linguistic groups, it is important to determine whether this reflects real group differences, or is the result of systematic measurement variability. PURPOSE: To investigate the linguistic measurement equivalence of a cancer-specific HRQL questionnaire, and to conduct a sensitivity analysis of treatment differences in HRQL in a clinical trial. METHODS: Patients with newly diagnosed chronic myelogenous leukemia (n = 1049) completed serial HRQL assessments in an international Phase III trial. Two types of differential item functioning (uniform and non-uniform) were evaluated using item response theory and classical test theory approaches. A sensitivity analysis was conducted to compare HRQL between treatment arms using items without evidence of differential functioning. RESULTS: Among 27 items, nine (33%) did not exhibit any evidence of differential functioning in both linguistic comparisons (English versus French, English versus German). Although 18 items functioned differently, there was no evidence of systematic bias. In a sensitivity analysis, adjustment for differential functioning affected the magnitude, but not the direction or interpretation of clinical trial treatment arm differences. LIMITATIONS: Sufficient sample sizes were available for only three of the eight language groups. Identification of differential functioning in two-thirds of the items suggests that current psychometric methods may be too sensitive. CONCLUSIONS: Enhanced methodologies are needed to differentiate trivial from substantive differential item functioning. Systematic variability in HRQL across different groups can be evaluated for its effect upon clinical trial results; a practice recommended when data are pooled across cultural or linguistic groups to make conclusions about treatment effects.

Clinical Trials, Phase III as Topic↗
PubMed2006

Future trends in patient-reported outcomes assessment for patients with advanced-stage lung cancer receiving targeted therapy.

Recent advances in cancer cell biology have led to the development of therapeutic agents that target pathways critical to the development and progression of disease. These so-called "targeted therapies" might offer patients a more tolerable alternative to traditional systemic chemotherapy that often achieves therapeutic benefit at the cost of debilitating side effects. Several targeted agents have been recently tested in clinical trials of advanced-stage lung cancer. As interest in these therapies grows, an understanding of their impact on the patient's well-being will be important. Patient-reported outcome measures such as formal assessments of health-related quality of life and disease symptoms provide a useful means for addressing the impact of therapy from the perspective of the patient. We summarize the most commonly used measures of health-related quality of life in clinical trials of advanced-stage lung cancer. Although existing measurement systems do provide adequate coverage of many important patient-related outcome issues, the advent of targeted therapies in advanced-stage lung cancer does expose several measurement gaps. We highlight some of these gaps by reviewing a representative sample of recently conducted clinical trials of targeted lung cancer therapy and offer insight as to how these gaps can be filled. We also briefly discuss a set of issues unique to patients receiving targeted therapy (eg, perceptions of treatment efficacy, treatment compliance, patient satisfaction, and treatment convenience) and consider a few methodologic concerns unique to patients with advanced cancer.

Clinical Trials as Topic↗
PubMed2006

Expansion of a physical function item bank and development of an abbreviated form for clinical research.

We expanded an existing 33-item physical function (PF) item bank with a sufficient number of items to enable computerized adaptive testing (CAT). Ten items were written to expand the bank and the new item pool was administered to 295 people with cancer. For this analysis of the new pool, seven poorly performing items were identified for further examination. This resulted in a bank with items that define an essentially unidimensional PF construct, cover a wide range of that construct, reliably measure the PF of persons with cancer, and distinguish differences in self-reported functional performance levels. We also developed a 5-item (static) assessment form ("BriefPF") that can be used in clinical research to express scores on the same metric as the overall bank. The BriefPF was compared to the PF-10 from the Medical Outcomes Study SF-36. Both short forms significantly differentiated persons across functional performance levels. While the entire bank was more precise across the PF continuum than either short form, there were differences in the area of the continuum in which each short form was more precise: the BriefPF was more precise than the PF-10 at the lower functional levels and the PF-10 was more precise than the BriefPF at the higher levels. Future research on this bank will include the development of a CAT version, the PF-CAT.

Activities of Daily Living↗
PubMed2006

Development and validation of the Functional Assessment of Cancer Therapy-Kidney Symptom Index (FKSI).

The Functional Assessment of Cancer Therapy (FACT)-Kidney Symptom Index (FKSI) was developed and validated to enhance treatment decision-making, practice guidelines, symptom management, and treatment efficacy for kidney cancer patients. Thirty-four symptoms related to the disease were identified and tested. An equal weighting of patient and clinician ratings of the relative importance of each of these items led to production of a 15-item index (FKSI-15) and a 10-item abbreviated option (FKSI-10). To assess psychometric properties, patients completed the FKSI, Functional Assessment of Cancer Therapy-General (FACT-G), Eastern Cooperative Oncology Group-Performance Status Rating (ECOG-PSR), and a Global Rating of Change Scale (GRCS). Patient responses to the FKSI were analyzed for internal consistency, test-retest reliability, convergent and discriminant validity, and responsiveness to change in clinical status. The FKSI-10 showed high internal consistency; correlations between both FKSI-10 and the physical and functional well being domains of the FACT-G were high. The FKSI-10 differentiated patients grouped by ECOG-PSR (all P < 0.001) and discriminated patients based on their GRCS rating. The minimally important difference (MID) range estimate for the FKSI-10 was 2-4 points; the psychometric properties of the FKSI-15 were very similar (MID range, 3-5 points).Thus, the FKSI-15 and FKSI-10 are reliable and valid symptom indices for evaluating kidney cancer patients.

Adult↗
PubMed2006

Quality of life and clinical decisions in chemotherapy-induced anemia.

Fatigue is common in cancer patients treated with chemotherapy, and it has detrimental effects on their quality of life. Chemotherapy-induced anemia, however, is often under-recognized and under-treated. There is a clear association between hemoglobin (Hgb) levels and fatigue, with fatigue being greater in patients with lower Hgb levels. Managing fatigue requires that its causes be determined and corrected, and it is important that patients report their fatigue. Patients, however, are unlikely to mention such adverse events unless they are asked about them. In addition, busy practitioners generally have very little time to discuss anemia-related fatigue with their patients. Many studies have used the validated quality-of-life instrument Functional Assessment of Cancer Therapy-Fatigue (FACT-F) to assess fatigue and quality of life in patients treated with chemotherapy; these studies have shown a relationship between chemotherapy-induced anemia, fatigue, and quality of life. Studies of erythropoiesis-stimulating proteins to treat chemotherapy-induced anemia have shown increases in patients' hemoglobin levels, improvement in their FACT-F and FACT-General scores, and improvements in their quality of life.

Anemia↗
PubMed2005

Anorexia/cachexia-related quality of life for children with cancer.

BACKGROUND: Anorexia is a common symptom in patients with cancer, which can lead to poor tolerance of treatment and can contribute to cachexia in extreme cases. Children with advanced-stage cancer are especially vulnerable to malnutrition resulting from anorexia and cachexia. Currently, there are no instruments that measure common concerns specifically associated with anorexia and cachexia in children with cancer. The purpose of the current article was to test the psychometric properties of a newly developed pediatric Functional Assessment of Anorexia and Cachexia Therapy (peds-FAACT) for children with cancer. METHODS: Ninety-six patients (ages 7-17 yrs) receiving cancer treatment and their parents were asked to complete the 12-item peds-FAACT. The authors implemented both classical test theory and item response theory to evaluate the agreement between parents and patients, internal consistency and unidimensionality of the scale, and stability of items across subgroups. RESULTS: As a result, a patient-reported six-item scale was recommended as the core measure for all pediatric patients with cancer and four additional peripheral items were recommended for adolescent patients. CONCLUSIONS: The peds-FAACT demonstrated good psychometric properties, differentiated patients with different functional performance status, and was determined to be a useful tool for future clinical trials.

Adolescent↗
PubMed2005

Quality-of-life comparisons in a randomized trial of interval secondary cytoreduction in advanced ovarian carcinoma: a Gynecologic Oncology Group study.

PURPOSE: To compare self-reported quality of life (QOL) in patients who did versus did not undergo interval secondary cytoreduction after initial surgery and combination chemotherapy for advanced ovarian cancer and to assess the association between baseline QOL scores and survival. PATIENTS AND METHODS: Consenting patients participating in a Gynecologic Oncology Group (GOG) phase III treatment trial (GOG 152) completed the Functional Assessment of Cancer Therapy-Ovarian (FACT-O) questionnaire and treatment-specific supplemental questions at the third and sixth chemotherapy cycles and at 6 and 12 months after starting treatment. RESULTS: For all patients, QOL decreased approximately 1 unit from the first to second assessment. Significant improvement observed at 6 months (P < .001) was sustained at 12 months, with no appreciable between-group difference. The baseline FACT-O score was associated with overall survival (P = .048) but not progression-free survival. Less neurotoxicity was reported among patients who did (38.4%) versus did not (54.0%) undergo interval secondary cytoreduction at the third assessment (P = .005), and older patients experienced more long-term effects. CONCLUSION: This is the first multicenter randomized trial in ovarian cancer to longitudinally examine self-reported QOL and establish a predictive value of baseline QOL on survival, attributed primarily to the lowest-scoring quartile. Although interval secondary cytoreduction resulted in no notable long-term difference, a clinically significant improvement was seen in both arms at 6 and 12 months after starting therapy. Interestingly, there were fewer complaints of neurotoxicity at 6 months among patients who did versus did not undergo interval secondary cytoreduction.

Adult↗
PubMed2005

Quality of life outcomes from a randomized phase III trial of cisplatin with or without topotecan in advanced carcinoma of the cervix: a Gynecologic Oncology Group Study.

PURPOSE: To prospectively assess the impact of treatment with cisplatin alone or in combination with topotecan (CT) on quality of life (QOL) in patients with advanced or recurrent cervical cancer, and to explore the prognostic value of baseline QOL scores. PATIENTS AND METHODS: Patients entered on Gynecologic Oncology Group (GOG) Protocol 179 were expected to complete QOL assessments at four time points using Functional Assessment of Cancer Therapy-General (FACT-G), Cervix subscale (Cx subscale), FACT/GOG-Neurotoxicity subscale (NTX subscale), Brief Pain Inventory (BPI), and UNISCALE (UNI). Adjusting for patient age, baseline scores, and effects of time, we longitudinally examined treatment effect on QOL during and after chemotherapy. RESULTS: Among patients randomly allocated to receive cisplatin (n = 146) or CT (n = 147), there were no statistically significant differences in QOL up to 9 months after randomization despite more hematologic toxicity in the combination arm. QOL assessments were completed at rates of 98%, 85%, 68%, and 59%, respectively, for the four time points, with similar rates and reasons for nonparticipation between regimens. Baseline FACT-G (P = .0016) and BPI (P = .0001) scores were significantly associated with patient age; older patients had better QOL and less pain. Baseline UNI was positively correlated with FACT-G (r = 0.66; P < .001) and Cx subscale (r = 0.29; P < .001), and negatively related to BPI (r = -0.41; P < .0001). Baseline FACT-Cx (FACT-G + Cx subscale) was associated with survival. CONCLUSION: Despite increased toxicity, CT did not significantly reduce patient QOL when compared with cisplatin alone. Patient-reported QOL measures may be an important prognostic tool in advanced cervix cancer.

Adult↗
PubMed2005

Clinically meaningful improvement in symptoms and quality of life for patients with non-small-cell lung cancer receiving gefitinib in a randomized controlled trial.

PURPOSE Evaluation of disease-related symptom improvement rate by the Lung Cancer Subscale (LCS) of the Functional Assessment of Cancer Therapy-Lung (FACT-L) questionnaire was a coprimary end point of the pivotal phase II trial of gefitinib (Iressa; AstraZeneca, Wilmington, DE) conducted in the United States. This report includes the results of analyses exploring the relationship between weekly LCS scores and radiographic response and survival, as well as detailed protocol-specified analysis of symptom and quality-of-life data. PATIENTS AND METHODS In this trial, 216 symptomatic patients with advanced non-small-cell lung cancer (NSCLC) who had at least two prior chemotherapy regimens received gefitinib 250 or 500 mg/d. Disease-related symptoms were assessed weekly and quality of life was assessed monthly by LCS and FACT-L, respectively. Results Symptom improvement was rapid and correlated with tumor response and survival. At the recommended gefitinib dose of 250 mg/d, median overall survival times were 13.6 and 4.6 months for patients with and without symptom improvement, respectively, and 9.7 months for patients with symptom improvement without tumor response. Among patients with stable disease or disease progression, those with symptom improvement had significantly better overall survival than those without improvement. At 250 mg/d, 30% of patients showed a quality-of-life improvement that was correlated with tumor response. CONCLUSION This triadic analysis of response, survival, and symptom data supports the hypothesis that tumor response and symptom response are related and that each predicts survival. Among these NSCLC patients treated with gefitinib, symptom improvement was complementary to and, for most patients, preceded evidence of radiographic regression.

Administration, Oral↗
PubMed2005

The price of pruritus: sleep disturbance and cosleeping in atopic dermatitis.

BACKGROUND: Atopic dermatitis is a common skin disorder that most often begins in infancy. Sleep disturbances in children with atopic dermatitis are likely due to itching and scratching and not only impact the afflicted child but may also affect the entire family. Sleep characteristics in young children with atopic dermatitis and their families have not been thoroughly investigated. OBJECTIVE: To evaluate sleep disturbance and cosleeping in young children with atopic dermatitis and evaluate the association between sleep characteristics and features of the disease. DESIGN AND METHODS: Parents of 300 children ranging in age from birth to 6 years with atopic dermatitis responded to 4 questions about sleep characteristics of their child and family. Analyses determined the prevalence of reported sleep disturbance and cosleeping, and their association with features of the patients and disease severity. RESULTS: Sleep disturbance attributed to atopic dermatitis was common; most parents (> 60%) reported that the dermatitis affected how well they or their child slept. Cosleeping because of the skin condition was reported by 30% of families, and most of these parents (66%) were bothered by the cosleeping. Sleep disturbance and cosleeping were directly associated with severity of atopic dermatitis and with the degree to which parents reported that the atopic dermatitis affected the child and family's happiness. CONCLUSIONS: Sleep disturbances were more common in children with atopic dermatitis than have been reported in children overall. These results demonstrate important sequelae of a very common childhood condition that warrant further investigation and the development of intervention strategies.

Adult↗