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Biomedical subjects

D Cella

Publications and source records attributed to D Cella.

At least 73 records · Page 4Linked to original sources
PubMed1995

RTOG's first quality of life study--RTOG 90-20: a phase II trial of external beam radiation with etanidazole for locally advanced prostate cancer.

PURPOSE: To assess institutional and patient compliance with quality of life (QL) instruments in RTOG clinical trials. To assess feasibility of using the Functional Assessment Cancer Therapy (FACT), Sexual Adjustment Questionnaire (SAQ), and Changes in Urinary Function (CUF) QL instruments in a prostate clinical trial and to compare patient self-report of symptoms to medical professional ratings of the same symptoms using the RTOG acute toxicity rating scales. METHODS AND MATERIALS: Three self-assessment QL instruments, the FACT, the SAQ, and CUF, were to be administered to patients on a Phase II locally advanced prostate trial at specified time points. Specific instructions for both data managers and for patients on when, how, and why to fill out the questionnaires were included. RESULTS: Sixty-seven percent (24 out of 36) of patients accrued to RTOG 90-20 completed both the initial FACT and SAQ. Eighty-five percent completed FACT at end of RT and 73% at 3 months. Eighty-one percent completed SAQ at end of treatment, while 69% completed this form at 3 months. Compliance drops off thereafter. Seventy-five percent of patients who had their symptom of dysuria rated by a medical professional as 0 on the RTOG toxicity rating scale self-reported the same. Only 56% of patient self-reports on FACT regarding diarrhea were in agreement with the medical professional's RTOG rating of 0 toxicity. The measures were determined to be in moderate agreement when the patient evaluated a symptom as a 1 on the FACT and the medical professional rated the same symptom as a 0 on the RTOG toxicity rating scale. There was moderate agreement in 13% of patients with dysuria and 31% of patients with diarrhea. Low agreement occurred when the patient evaluated a symptom as a 2 or 3 on the FACT and the medical professional rated the same symptom as a 0 on the RTOG scale. Low agreement occurred in 13% of both patients reporting dysuria and diarrhea. Differences between how medical professionals and patients were able to rate erectile function make direct comparisons difficult, but the trend towards significant discrepancies is still noteworthy. CONCLUSIONS: Quality of life assessments are necessary and attainable in RTOG clinical trials. Compliance rates for both institutional and patient participation were acceptable at initial and 3 month follow-up. Reasons for noncompliance were predominantly institution related and not patient related. Strategies to address both institution and patient compliance have been developed and implemented within the RTOG. Serious disagreement between patient self-reports of symptoms on the FACT QL scale and medical professional ratings on the RTOG acute toxicity rating scales of the same symptoms was 13% at 3 months follow-up. This warrants continued use of QL self-assessments in clinical trials.

Adenocarcinoma↗
PubMed1993

Developing and evaluating cross-cultural instruments from minimum requirements to optimal models.

In the age of increased international collaboration in medical research, the necessity of having at hand cross-culturally applicable instruments for the assessment of health-related quality of life (HRQL) in clinical trials has been voiced. Several important theoretical bases leading to cultural bias in HRQL measurement include differences in definitions of HRQL across national and cultural contexts, levels of observation relied upon to indicate HRQL states, and the significance or weight placed upon the various HRQL states or dimensions measured. Despite a growing literature on the development and evaluation of existing HRQL measures in other cultures, comprehensive sets of procedures or requirements for the international part of development and evaluation are lacking. This paper reviews major approaches to developing international HRQL measures, and discusses various methods and criteria that have been recommended for evaluating measurement equivalence in comparisons of research across national and cultural contexts. A summary of recent trends and advances in international HRQL assessment is presented.

Bias↗
PubMed1992

[Changes in dynamic respiratory volumes in obese children and adolescents related to weight loss and sex].

Obesity is associated with various alterations in lung function in adults. These alterations appear to be proportional to the degree of EP and the beneficial effect of weight loss on respiratory function has been reported. Therefore, in 35 children and adolescents affected by essential obesity of medium-severe degree, we have evaluated the following parameters: FVC (forced vital capacity), PEF (peak expiratory flow), FEV1 (forced expiratory volume), FEV75, FEV50, FEV25, before and after six months of dieting. Twelve subjects (34%) showed at least a pathologic value of PEF and/or FEV50 before dieting. All the female patients normalized their parameters after six months of dieting, whilst 5 out of 7 males still showed pathologic respiratory indexes, although a similar weight loss was obtained in the two groups of patients. Our study enhances the presence of respiratory functions derangements in a significant percentage of children with medium-severe degree of obesity. A careful monitoring of these subjects is therefore necessary, in order to prevent further progression of the lung function damage. After dieting the pulmonary function improved in female patients only, suggesting that factors other than the EP are involved in the pathogenesis of the respiratory alterations.

Adolescent↗
PubMed1989

Interview assessment of critically Ill patients regarding resuscitation decisions. A case study in ethics research.

To examine how patients perceive and decide their resuscitation status, we monitored 113 admissions to a coronary care unit. We review the research process, including Institutional Review Board concerns, sampling bias and permission by physicians, informed consent, and the patient interview. In-depth psychiatric interviews on 16 patients demonstrated marked misperceptions about resuscitation procedures. Although standardized psychologic measures indicated distress in some of these critically ill patients, the interview itself induced no detected untoward physiologic or emotional reactions. This pilot study demonstrates the feasibility of assessing patients regarding resuscitation status and also identifies relevant methodologic problems to guide future research of resuscitation decision-making.

Behavioral Research↗
PubMed1986

Selection and change of specialties by medical school graduates.

Previous studies of reasons for choosing medical specialties have been restricted to one specialty or to surveys of medical students. Since some students change their specialties after medical school, the present authors surveyed the graduates of a medical college's classes of 1971 through 1982 in regard to their selection of a number of different specialties. Overall, factors related to the content of the specialty and to contact with patients were rated as the most important in choosing a specialty; the quality of the medical college educational program was rated as of intermediate importance and life-style and personal factors as of least importance. Thirteen percent of those surveyed made major changes in specialties after graduation, with more of them leaving than entering internal medicine, pediatrics, and family practice and more of them entering than leaving the hospital service specialties (such as radiology and pathology) and psychiatry. The reasons for these changes involved financial and life-style considerations, for example, working hours, location, and financial rewards of practice.

Career Choice↗
PubMedDate not supplied

Missing data in quality of life research in Eastern Cooperative Oncology Group (ECOG) clinical trials: problems and solutions.

Incorporation of quality of life (QOL) investigation into Eastern Cooperative Oncology Group (ECOG) multi-centre clinical trials has led to innovative strategies for protocol design and high quality data collection. A scientific advisory committee reviews protocol design components, measurement selection, timing of assessments and compliance issues. Extensive educational programmes provide information about the scientific and clinical relevance of QOL protocols, as well as practical strategies for data collection and management. Compliance with QOL data collection standards is prospectively monitored and evaluated. Preliminary results from eight ECOG-run protocols found overall compliance to be approximately 85 per cent (94 per cent at baseline and 73 per cent during treatment). Selected patient and institutional factors were evaluated for their association with compliance.

Adult↗
PubMedDate not supplied

Comparison of several model-based methods for analysing incomplete quality of life data in cancer clinical trials.

This paper considers five methods of analysis of longitudinal assessment of health related quality of life (QOL) in two clinical trials of cancer therapy. The primary difference in the two trials is the proportion of participants who experience disease progression or death during the period of QOL assessments. The sensitivity of estimation of parameters and hypothesis tests to the potential bias as a consequence of the assumptions of missing completely at random (MCAR), missing at random (MAR) and non-ignorable mechanisms are examined. The methods include complete case analysis (MCAR), mixed-effects models (MAR), a joint mixed-effects and survival model and a pattern-mixture model. Complete case analysis overestimated QOL in both trials. In the adjuvant breast cancer trial, with 15 per cent disease progression, estimates were consistent across the remaining four methods. In the advanced non-small-cell lung cancer trial, with 35 per cent mortality, estimates were sensitive to the missing data assumptions and methods of analysis.

Breast Neoplasms↗
PubMedDate not supplied

Telephone counseling of breast cancer patients after treatment: a description of a randomized clinical trial.

The Telephone Counseling Trial for Breast Cancer Survivors is a randomized, controlled study designed to test the impact of a telephone-based counseling intervention on quality of life of early-stage breast cancer patients who have completed adjuvant treatment. A psychoeducational counseling model is utilized to promote adaptive coping to re-entry stressors and survivorship issues. Adaptation is fostered through the exploration of thematic materials, application of active coping strategies, encouragement of a personal expression of the breast cancer experience and the provision of psychological support. Patients are being recruited in collaboration with two NCI-designated clinical cooperative oncology groups: the Eastern Cooperative Oncology Group (ECOG) and the Southwest Cooperative Oncology Group (SWOG). The recruitment goal is 400 breast cancer survivors with Stage 1, Stage 2 and Stage 3 disease (with no greater than 10 positive lymph nodes involved). Patients are being enrolled by data managers on-site during their last treatment visit. The intervention is being delivered by the Cancer Information and Counseling Line (CICL) of the AMC Cancer Research Center. It includes 16 telephone outcalls which are delivered over a 12-month period. Primary outcome measures are quality of life, mood, social support, self-efficacy, and sexual functioning, assessed at baseline, 3, 6, 12 and 18 months follow-up. This article provides a description of the intervention protocol and study design. It is argued that this study could provide a model for developing and testing other psychosocial interventions within clinical cooperative groups nationwide.

Adaptation, Psychological↗
PubMedDate not supplied

The impact of a brief coping skills intervention on adherence to breast self-examination among first-degree relatives of newly diagnosed breast cancer patients.

The present investigation sought to determine (1) the impact of a single session stress management/coping intervention (problem-solving training; PST) versus a general health counseling (GHC) control condition on breast self-examination (BSE) adherence among relatives of newly diagnosed breast cancer patients, and (2) whether women with heightened perceived risk of breast cancer and/or cancer specific distress at baseline were more likely to improve their BSE adherence following PST. The participants were 510 women age 20-75 who had at least one first-degree relative with breast cancer. All of the participants completed a baseline telephone interview, an intervention (PST versus GHC), and a 3-month follow-up telephone interview. The results revealed a 36% overall improvement in BSE adherence, with no significant between-group difference in improvement (chi 2 = 0.03, p = 0.87). The logistic regression analysis of improvement in BSE adherence revealed a statistically significant cancer-specific distress by treatment interaction (p = 0.04). Among women who received PST, those with high levels of cancer-specific distress were two times more likely to improve in BSE adherence than women low in cancer-specific distress. There was no effect of cancer-specific distress in the control condition. These results suggest that women with a family history of breast cancer who have high levels of distress may be most likely to benefit from behavioral coping skills intervention to promote adherence to breast cancer screening.

Adaptation, Psychological↗
PubMedDate not supplied

A case for including spirituality in quality of life measurement in oncology.

Most of the commonly used quality of life (QOL) instruments in oncology do not include spirituality as a core domain. However, previous research suggests that spirituality might be an important aspect of QOL for cancer patients and that it may, in fact, be especially salient in the context of life-threatening illness. This study used a large (n=1610) and ethnically diverse sample to address three questions relevant to including spirituality in QOL measurement: (1) Does spirituality demonstrate a positive association with QOL?; (2) Is this association unique?; and (3) Is there clinical utility in including spirituality in QOL measurement? Spirituality, as measured by the Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being (FACIT-Sp), was found to be associated with QOL to the same degree as physical well-being, a domain unquestioned in its importance to QOL. The significant association between spirituality and QOL was unique, remaining after controlling for core QOL domains as well as other possible confounding variables. Furthermore, spiritual well-being was found to be related to the ability to enjoy life even in the midst of symptoms, making this domain a potentially important clinical target. It is concluded that these results support the move to the biopsychosocialspiritual model for QOL measurement in oncology.

Adaptation, Psychological↗
PubMedDate not supplied

The effect of Epoetin alfa on quality of life in anemic cancer patients.

OBJECTIVES: The purpose of this paper is to review evidence on the use of Epoetin alfa in the treatment of anemia associated with cancer treatment through a discussion of clinical and quality-of-life considerations. MATERIALS AND METHODS: Cancer patients often experience fatigue, which leads to reduced quality of life. There are few effective treatments available to manage this potentially debilitating symptom, which can lead clinicians to become discouraged about treating fatigue. When cancer-related fatigue is due to anemia, there are viable treatment options. This paper reviews the current management of anemia in cancer patients, with an emphasis on the use of recombinant human erythropoietin (Epoetin alfa). CONCLUSIONS: Anemia can contribute to the reduced quality of life experienced by cancer patients. Blood transfusion, the traditional method of treating anemia, is effective and relatively inexpensive, but is associated with certain risks and is subject to limitations in blood supply. Epoetin alfa therapy provides healthcare providers with an effective alternative to blood transfusion, and trial results suggest that this intervention has a positive effect on patients' quality of life. The optimal starting and stopping points for therapy have not yet been determined. In practice, many physicians begin treatment when hemoglobin levels drop below 10 g/dL and stop when they rise above 13 g/dL, with a 75% dose reduction until completion of chemotherapy if hemoglobin again drops below 12 g/dL. Nonresponse (< 1 g/dL rise in hemoglobin) is met with dose increase at 4 weeks and discontinuation after 8 weeks. Controlled studies comparing anemia management via transfusion to the use of Epoetin alfa have not been done to date. Therefore, the relative cost-effectiveness of Epoetin alfa, an effective but expensive intervention, remains unknown.

Anemia↗
PubMedDate not supplied

Osteoporosis: a disease management opportunity.

Advances in the ability to detect and effectively treat osteoporosis lead to questions about when testing and treatment should be initiated. Disease management provides answers with the promise of both cost-effective use of resources and improved health outcomes. Applying the characteristics and principles of disease management to osteoporosis provides a powerful rationale for a population-based approach to this disease. Disease management makes it possible to systematically identify persons at risk, intervene with prevention and treatment programs, and measure clinical, quality of life, and economic outcomes. Clinical guidelines are a critical element in disease management. This article presents clinical guidelines developed recently by national medical and public health experts based on a review of available research and clinical evidence.

Aged↗
PubMedDate not supplied

Vulvar cancer patients' quality of life: a qualitative assessment.

To develop a vulvar cancer-specific quality of life (QOL) subscale to accompany the Functional Assessment of Cancer-General (FACT-G) questionnaire, semistructured interviews were performed with 15 patients treated for vulvar cancer (FIGO stage 0-3). All but one patient, who received chemoradiotherapy, were treated by radical vulvectomy and six patients received a groin lymph node dissection. Patients experienced reductions in several aspects of QOL including emotional functioning, physical functioning, social functioning, sexuality, and body image. Six patients suffered from lymphedema of the legs with a mean severity of 3.5 on a 10-point scale. Four patients reported pruritus (severity rating 8.5). Seven patients expressed a need for more information about the illness and treatment. Only four patients returned to employment after treatment, and all of these patients reported work-related problems. Reductions in sexual functioning were a major concern for five patients, all younger than 65 years. Other topics were groin discomfort after removal of the lymph nodes and disturbance by odor from the vulva. Results of this study revealed vulvar cancer-specific reductions in QOL for inclusion in the newly developed vulvar cancer-specific subscale.

Age Factors↗
PubMedDate not supplied

Psychometric evaluation of the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (Fact/GOG-Ntx) questionnaire for patients receiving systemic chemotherapy.

The purpose of this study was to validate the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx) questionnaire. The FACT/GOG-Ntx is the FACT-G plus an eleven-item subscale (Ntx subscale) that evaluates symptoms and concerns associated specifically with chemotherapy-induced neuropathy. Two groups of women with ovarian cancer completed the FACT/GOG-Ntx: one group with known neurotoxicities and one group of chemotherapy-naive women newly diagnosed with ovarian cancer. Levels of patient neuropathy, severity of toxicity, and patient quality of life from diagnosis of ovarian cancer to 12 months post-diagnosis were assessed. The Ntx subscale significantly differentiated the two groups at baseline and 3- and 6-month follow-ups, demonstrating significantly fewer problems among chemotherapy-naive patients than among patients with known neuropathy. The FACT/GOG-Ntx is a reliable and valid instrument for assessing the impact of neuropathy on health-related quality of life. The Ntx subscale demonstrated sensitivity to meaningful clinical distinctions and change over time.

Aged↗
PubMedDate not supplied

Measurement of vaginal length: Reliability of the vaginal sound--a Gynecologic Oncology Group study.

A decrease in vaginal length associated with treatments for gynecological malignancies, particularly pelvic radiotherapy, negatively impacts sexuality. Research into this important problem has been hampered by a lack of instrumentation to measure vaginal length. The Gynecologic Oncology Group recently evaluated the reliability of an instrument, the "vaginal sound," designed to measure vaginal length. Eighty-eight physicians and nurses attended a training session in the use of the vaginal sound that included a clinical practicum with live models. Reliability was assessed at the time of the practicum. The instrument performed well, with vaginal lengths in models without cancer in the upper range of normal as documented by Masters and Johnson. The vaginal sound also appeared to be sensitive to hypothesized changes in vaginal length. Interrater reliability was high with intraclass correlation coefficients of 0.88 among instructors and 0.76 among trainees. In conclusion, the vaginal sound is a simple, yet reproducible measure and adds methodologic rigor to studies of vaginal length.

Adult↗
PubMedDate not supplied

Outpatient taxol and carboplatin chemotherapy for suboptimally debulked epithelial carcinoma of the ovary results in improved quality of life: an Eastern Cooperative Oncology Group Phase II Study (E2E93).

PURPOSE: The combination of a platinum compound and paclitaxel is a standard treatment for ovarian cancer. In this cooperative group trial, paclitaxel and carboplatin were combined in an outpatient schedule to determine the clinical benefit, toxicities, and effect on quality of life. PATIENTS AND METHODS: Women with International Federation of Gynecology and Obstetrics stage II to IV epithelial ovarian cancer with suboptimal residual disease (> 1 cm) were eligible. Paclitaxel, 150 mg/m2, was given over 3 hours, followed by carboplatin (area under the curve, 5). This was repeated every 4 weeks for six cycles. Quality of life was assessed using the Functional Assessment of Cancer Therapy-Ovarian Cancer scale. Fifty-nine patients were enrolled, 38 with measurable disease and 21 with evaluable disease. RESULTS: The response rate (complete response + partial response) was 72%. The progression-free interval for patients with measurable disease was 17.5 months and for patients with evaluable disease was 11.1 months. Median survivals were 30.1 months (measurable) and 25.7 months (evaluable). Toxicities were modest. Quality-of-life scores improved significantly during therapy. DISCUSSION: This regimen is ideal for most women with advanced ovarian cancer because it is convenient and well tolerated, with response and survival comparable to those of more aggressive regimens. Overall quality-of-life scores and physical well-being scores improved throughout this outpatient treatment regimen for most patients.

Adult↗
PubMedDate not supplied

The promise of PROMIS: using item response theory to improve assessment of patient-reported outcomes.

PROMIS (Patient-Reported-Outcomes Measurement Information System) is an NIH Roadmap network project intended to improve the reliability, validity, and precision of PROs and to provide definitive new instruments that will exceed the capabilities of classic instruments and enable improved outcome measurement for clinical research across all NIH institutes. Item response theory (IRT) measurement models now permit us to transition conventional health status assessment into an era of item banking and computerized adaptive testing (CAT). Item banking uses IRT measurement models and methods to develop item banks from large pools of items from many available questionnaires. IRT allows the reduction and improvement of items and assembles domains of items which are unidimensional and not excessively redundant. CAT provides a model-driven algorithm and software to iteratively select the most informative remaining item in a domain until a desired degree of precision is obtained. Through these approaches the number of patients required for a clinical trial may be reduced while holding statistical power constant. PROMIS tools, expected to improve precision and enable assessment at the individual patient level which should broaden the appeal of PROs, will begin to be available to the general medical community in 2008.

Diagnosis, Computer-Assisted↗