Comparison of a single global item and an index of a multi-item health status measure among persons with and without diabetes in the US.

This study examined the hypothesis that a single global item can be substituted for an index of a multi-item assessment and lead to equivalent interpretative outcomes. Substitutability would be demonstrated if: (1) the two measures were strongly correlated, and regression analysis showed that the same variables accounted for variation in each measure, and (2) difference scores between multi-item and global scores were close to zero and remained so as socio-demographic and co-morbid conditions varied. A multi-item assessment was constructed by mapping items from the NHANES I Epidemiologic Follow-up Study (NHEFS), using available data for persons with and without diabetes, onto the health-status classification system of the Health Utilities Index Mark 1 (HUI), creating the NHEFS-HUI. NHEFS-HUI data, when correlated to the self-assessed health status (SAHS) item, revealed a coefficient of 0.55. Regression analyses identified 9 of 14 variables contributed to the variability of each health status index, but differences existed in which variables were significant for which measure. Five of the possible 14 difference scores for persons with diabetes and non-diabetics approached zero. Persons with diabetes had lower NHEFS-HUI scores than non-diabetics. These data were considered insufficient for demonstrating substitutability. Suggestions were made on how optimal substitutability could be achieved.

Elective discontinuation of life-sustaining mechanical ventilation on a chronic ventilator unit.

Withdrawal of medical interventions has become common in the hospital for patients with terminal disease. Despite the widespread feeling that medical interventions may be futile in certain patients, many patients, families, and medical staff find withdrawal of care difficult and withdrawal of mechanical ventilation to be the most disturbing secondary to the close proximity of withdrawal and death. Presented is a 6-year retrospective review of elective withdrawal of life-sustaining mechanical ventilation on a chronic ventilator unit (CVU) in an academic nursing home. Of the 98 patients admitted to the 19-bed CVU during this period, only 13 underwent terminal weaning (TW). Statistically, these 13 patients did not differ significantly in age, gender, race, route of nutrition, decisional capacity, or length of stay on the unit compared with the 85 patients who were not terminally weaned (t-test P > .05). Stepwise logistic regression found that patients who were more alert at admission were more likely to have participated in TW (chi2 = 5.22, coefficient for alertness P < .036). The decision to terminate mechanical ventilation was made by patients in eight cases and by family in five cases. The first step in the process leading to TW was a discussion with the patient and family about plan of care, including the patient's desires for attempted resuscitation, rehospitalization, advance directives, and family contacts. Plan of care was reviewed informally in a weekly multidisciplinary round and formally, to address each patient's care plan, in a multidisciplinary family meeting on a regular basis. The second step was to address TW when brought up by the patient, family, or medical staff. A request for TW by a patient or surrogate was referred to the medical staff, who screened the patient for depression or other remediable symptoms. The third step was to refer the patient and family to another formal meeting to discuss the request for TW and, if needed, in the case of multiple family members, to allow questions to be answered and consensus to be formed. Additional meetings were scheduled as needed. The next step occurred once a consensus was reached to proceed with TW; a date and time was set to reconvene the patient, family, and anyone else who wanted to be present at the TW. The TW process began when a peripheral intravenous catheter was placed and the patient was premedicated with low doses of morphine sulfate and a benzodiazepine. After premedication, the patient was removed from the ventilator. The physician, nurse, family, and physician assistant remained at the bedside and additional morphine or benzodiazepine was given, as needed, for symptom management. Death from TW occurred in all patients, at times ranging from 2 minutes to 10.5 hours (average 6.2 hours). A mean total dose of 115 mg morphine and 14 mg diazepam was given for symptom control. There was no correlation between dose of these medications and duration of survival off the ventilator.

Obesity and health-related quality of life.

Although it is well documented that obesity is strongly associated with morbidity and mortality, less is known about the impact of obesity on functional status and health-related quality of life (HRQL). However, in recent years research has been conducted to estimate the impact of obesity on HRQL, and to determine the effects of weight reduction on HRQL. The majority of published studies indicate that obesity impairs HRQL, and that higher degrees of obesity are associated with greater impairment. Obesity-associated decrements on HRQL tend to be most pronounced on physical domains of functioning. Studies of the effect of obesity surgery among morbidly obese patients indicate that this procedure produces significant and sustained improvements in the majority of HRQL indices; among mild-to-moderately obese persons, modest weight reduction derived from lifestyle modification also appears to improve HRQL, at least in the short term. Additional research is needed to (1) further characterize the effect that obesity has on HRQL; (2) estimate the short- and long-term effects of various methods of weight reduction (e.g. surgery, lifestyle modification) on HRQL; (3) improve both the conceptualization and measurement of HRQL to incorporate the personal preferences and values of the patient; and (4) develop ways to enhance and sustain positive changes in HRQL, even if weight maintenance is elusive.

Health-related quality of life: methods of assessment.

Developing a health-related quality of life (HRQOL) assessment requires both a conceptual model and an extended plan whereby the assessment can continue to be developed with repeated applications. While generic HRQOL assessments exist and can be readily applied, it is when the assessment is integrated into the treatment development process that it is of most value, and to do this optimally requires either disease or study-specific assessments. Investigators were encouraged to view the assessment task as an information processing activity, and to be as concerned about how a person generates an HRQOL assessment as much as what they state their HRQOL to be. The added value of doing an HRQOL assessment is also discussed.

Recommendations on health-related quality of life research to support labeling and promotional claims in the United States.

Health-related quality of life (HRQL) outcomes evaluation is becoming an important component of clinical trials of new pharmaceuticals and medical devices. HRQL research provides patients, providers, and decision makers with important information on the impact of disease and treatment on physical, psychological, and social functioning and well-being. These outcomes are also useful to the pharmaceutical and device industries as they attempt to understand and communicate product value to physicians, patients, health insurers and others. HRQL labeling and promotional claims in the US are likely to increase over the next few years. The evidentiary requirements to make such a claim should be based on accepted scientific standards of HRQL evaluation and consistent with the regulatory requirements for clinical efficacy. This report outlines the scientific practices that should be considered in the evaluation of evidence for an HRQL claim, including the selection of appropriate domains, evidence to support the reliability and validity of HRQL measurement, considerations in research design and statistical analyses, and the issue of clinical significance. Representatives from the pharmaceutical and device industries, regulatory agencies, and the HRQL scientific community should work together to make certain the use of HRQL in labeling and promotion are based on sound scientific evidence, and that these messages are clearly and accurately reported to the consumers.

Health-related quality of life among obese persons seeking and not currently seeking treatment.

OBJECTIVE: To compare sociodemographic characteristics and health-related quality of life (HRQL) between groups of obese persons who sought and did not seek university-based treatment for overweight. METHOD: Three-hundred twelve consecutive obese persons sought outpatient university-based weight management treatment. The sample of obese persons (N = 89) who indicated that they were not currently trying to lose weight was derived from a larger convenience sample (N = 232) of persons surveyed in a hospital setting. Both groups completed sociodemographic and brief medical history questionnaires and the HRQL as measured by the Medical Outcomes Study Short-Form-36 Health Survey (SF-36). RESULTS: Obese persons who had sought treatment tended to be heavier, older, Caucasian, married, in white collar employment, and reported a higher prevalence of diabetes, hypertension, and pain. In multivariate analyses, both adjusted and unadjusted for these differences, obese persons who had sought treatment were significantly more impaired on the bodily pain, general health, and vitality HRQL domains than those who were not trying to lose weight. DISCUSSION: Although differences on sociodemographic and medical variables between the two groups may attenuate the obesity-HRQL relationship somewhat, obesity appears to have a pronounced impact on important dimensions of HRQL independent of whether or not the person is attempting to lose weight

Impact of weight loss on health-related quality of life.

To examine the effect of treatment-induced weight loss on Health-Related Quality of Life (HRQL), 38 mildly-to-moderately overweight persons recruited to participate in a study to examine the efficacy of a lifestyle modification treatment program completed a sociodemographic questionnaire, the Beck Depression Inventory (BDI), the Medical Outcomes Study Short-Form Health Survey (SF-36, as an assessment of HRQL), and underwent a series of clinical evaluations prior to treatment. After baseline evaluations, participants were randomly assigned to either a program of lifestyle physical activity or a program of traditional aerobic activity. Participants again completed the SF-36 and BDI after the 13-week treatment program had ended. Weight loss averaged 8.6 +/- 2.8 kg over the 13-week study. We found that weight loss was associated with significantly higher scores (enhanced HRQL), relative to baseline, on the physical functioning, role-physical, general health, vitality and mental health domains of the SF-36. The largest improvements were with respect to the vitality, general health perception and role-physical domains. There were no significant differences between the lifestyle and aerobic activity groups on any of the study measures. These data indicate that, at least in the short-term, weight loss appears to profoundly enhance HRQL.

Do psychogenic dysphagia patients have an eating disorder?

Patients who report dysphagia, but have no detectable physical defect, have often been diagnosed as having an eating disorder. This diagnosis was evaluated by administering the Eating Disorders Inventory-2 (EDI-2) and a measure of distress, the Symptom Checklist-90 (SCL-90R), to a sample of 21 adult psychogenic dysphagia patients (PDPs). Their EDI-2 responses were then compared with samples of anorexics, college men, and college women, and their SCL-90R responses were compared with published data of patients with dysphagia due to a motility disorder, an obstruction, or neither. Relative to the anorexics, the PDPs scored significantly lower on all EDI-2 dimensions except maturity fears. For the SCL-90R, PDPs scored significantly higher on the interpersonal sensitivity, depression, anxiety, and general severity index than did the dysphagia comparison groups. Moreover, PDP scores on the anxiety and interpersonal sensitivity dimensions were indicative of clinically significant distress. These findings suggest that PDPs do not appear to have an eating disorder, but that they report clinically significant levels of psychological distress, particularly anxiety.

Pain in the obese: impact on health-related quality-of-life.

Obesity is a major public health problem associated with increased health risks, chronic pain, and decrements in functional health status and subjective well-being. To examine the impact of pain on Health-Related Quality-of-Life (HRQL). 312 consecutive persons seeking medically-supervised weight loss treatment completed a sociodemographic questionnaire, the Medical Outcomes Study Short-Form Health Survey (SF-36), and underwent a series of clinical evaluations. Forty-eight percent of the patients when asked to rate "How much pain have you had in the last four weeks?" reported at least moderate pain in the four weeks prior to treatment. In analyses adjusted for sociodemographic factors, body-mass index (BMI) (kg/m2), and depression, obese patients reporting pain scored significantly lower on all SF-36 domains than those not reporting pain. Findings indicate that the pain itself is independently associated with impaired HRQL in nearly half of obese persons seeking treatment. These data demonstrate that pain is a strong covariate of obesity and, therefore, may need to be considered in the design and development of obesity treatments.

Health-related quality of life in obese persons seeking treatment.

BACKGROUND: The relationship between obesity and increased risks of morbidity and mortality is well established. Less is known about the impact of obesity on functional health status and subjective well-being. METHODS: We examined health-related quality of life (HRQL), measured by the Medical Outcomes Study Short Form-36 Health Survey (SF-36), and clinical characteristics of 312 consecutive persons seeking outpatient treatment for obesity at a university-based weight management center. SF-36 scores were adjusted for sociodemographic factors and various comorbidities, including depression, to better estimate the effect of obesity on HRQL. Health-related quality of life of the obese patients was then compared with that of the general population and with a sample of patients who have other chronic medical conditions. RESULTS: Compared with general population norms, participants who had a mean body-mass index (BMI) of 38.1 reported significantly lower scores (i.e., more impairment) on all eight quality-of-life domains, especially bodily pain and vitality. The morbidly obese (mean BMI, 48.7) reported significantly worse physical, social, and role functioning, worse perceived general health, and greater bodily pain than did either the mildly (mean BMI, 29.2) or moderately to severely obese (mean BMI, 34.5). The obese also reported significantly greater disability due to bodily pain than did patients with other chronic medical conditions. CONCLUSIONS: Obesity profoundly affects quality of life. Bodily pain is a prevalent problem among obese persons seeking weight loss and may be an important consideration in the treatment of this population.

Physiological tests to predict long-term outcome of total abdominal colectomy for intractable constipation.

OBJECTIVE: Total abdominal colectomy (TAC) for intractable constipation has a variable reported success rate that decreases to 50% beyond 2 yr. We hypothesize that this inconsistent outcome can be explained by a more extensive intestinal involvement in some patients. DESIGN: A consecutive sample of patients with intractable constipation had preoperative evaluations that included both upper and lower GI studies. Stool frequency, constipation, diarrhea, abdominal pain, and laxative or enema requirements were compared before and after operation. The study took place in an academic referral center and included 37 consecutive referred patients with severe intractable constipation and colonic dysmotility documented by radiopaque marker studies. INTERVENTIONS: TAC, with ileoproctostomy in 34 patients and ileostomy in three. MAIN OUTCOME MEASURES: Patients with motility abnormalities only of the lower GI tract were diagnosed as having colonic inertia (CI). Those with motility disorders of both the upper and the lower GI tracts were considered to have generalized intestinal dysmotility (GID) with colon predominance. RESULTS: Twenty-one patients had CI, and 16 had GID. Ninety percent of CI patients undergoing TAC had a successful outcome with a mean of 23 bowel movements (BMs)/wk at a mean follow-up of 7.5 yr. Although 88% of GID patients had initial improvement, with a mean of 19 BMs/wk at 6 months, only 13% had prolonged relief. After 2 yr, nine of the GID patients had recurrent constipation, and three had severe diarrhea. CONCLUSIONS: This study has identified two distinct types of colonic dysmotility, CI and GID. It has demonstrated the long-term success of TAC for CI and the importance of upper GI physiological studies to identify colon-predominant GID, which has a poor long-term response to TAC.

The status of psychosocial research in the rehabilitation of the cancer patient.

This article has tried to describe the current status of psychosocial research in the rehabilitation of the cancer patient. It attempted to weave together the author's perspective of how decisions early in the history of sponsored research programs, particularly by the National Cancer Institute, combined with a limited knowledge base led to limited growth of the Rehabilitation Program. Thus, the current status of psychosocial cancer rehabilitation can be reasonably attributed to the decision at the National Cancer Institute to encourage the development of cancer rehabilitation services, rather than to aggressively expand the knowledge base. Although, in retrospect, it is possible to criticize these decisions, in fact, they were legitimate choices among a wide range of options. It was also not possible in this article to discuss many topics in psychosocial cancer rehabilitation, particularly differences in psychosocial adjustment as a function of type of cancer. What the study attempted to do was to confront the impression that cancer rehabilitation, in general, and psychosocial cancer rehabilitation, in particular, are ancillary activities that can receive a secondary level of resource allocation and support. The point was made that determining if psychosocial rehabilitation is possible raises as many basic research questions as does understanding how chemotherapy works or how a malignancy develops. All three areas ask legitimate basic research questions on how the body works and how behavior changes. Today, 10 years after the start of the original Rehabilitation Program, psychosocial cancer rehabilitation is an established field of study and an integral part of most major oncology services. Now, as stated, what is needed is an expansion of its knowledge base. Some of the issues that are deserving of support include studies on cosmesis, to what extent voluntary processes can compensate loss in speech and swallowing functions, functional evaluation following alternative surgical procedures, what is the quality of life following long-term survival of cancer, what are the group dynamics following return of a cancer patient to a work site, and so on. Each of these research questions can be guided by the same model developed for cancer control research by Greenwald and Cullen. Other more general approaches include recognizing and promoting the preventative dimension of cancer rehabilitation and developing the art and practice of psychometric assessment of psychosocial aspects of cancer rehabilitation, just to name two such areas. The American Cancer Society also recently sponsored a meeting to review and set new directions for psychosocial rehabilitation research.(ABSTRACT TRUNCATED AT 400 WORDS)

Definition and measurement of fatigue.

Although fatigue is a key component of the chronic fatigue syndrome, its definition and measurement remain relatively undeveloped. Most research on fatigue has been oriented towards work or performance of tasks and has involved laboratory studies of healthy individuals, while the study of fatigue as encountered in clinical settings has received minimal attention from investigators. This paper recommends that the natural history of chronic fatigue in its various clinical presentations be studied and that standardized assessment tools be used in this process. An investigation of the tools available for the assessment of fatigue yielded single-item, unidimensional, and multidimensional instruments. Additionally, the apparent association between affective illness and the chronic fatigue syndrome is addressed, and the fact that this relationship depends on issues of measurement is explored.

Toxicity studies of adjuvant intravenous versus intraperitoneal 5-FU in patients with advanced primary colon or rectal cancer.

Clinical studies were prospectively conducted to quantitate the toxic side-effects of 5-FU administered by either the intravenous (i.v.) or intraperitoneal (i.p.) route. Sixty-six patients were treated following resection of a primary large bowel cancer after randomization to receive 5-FU by i.p. or i.v. routes. In both groups of patients, the dose of drug was increased a fixed amount until a toxic response occurred. At this point, the dose of drug was maintained or reduced in an attempt to complete 12 monthly treatment cycles of chemotherapy. The overall mean dose of drug administered by the i.p. route (1,479 mg) was significantly greater than given i.v. (1,019 mg), as it was for each treatment cycle. The primary adverse side-effect, resulting in drug dose stabilization or reduction, was leukocyte suppression of i.v. 5-FU or physical symptoms (abdominal pain or discomfort) for i.p. 5-FU (p2 = 0.0006 and p2 = 0.0318, respectively). The most frequent symptom reported by all patients was fatigue. Even though i.v. 5-FU dose was titrated to reduce toxicity, the nadir leukocyte count was suppressed over all cycles. The total numbers of immediate and delayed serious complications that resulted from i.v. or i.p. 5-FU were similar, although the nature of these complications differed markedly between the two routes of drug administration. Failure to complete 5-FU chemotherapy was significantly more common if patients received i.v. 5-FU plus pelvic irradiation. These studies indicate that intraperitoneal 5-FU administration decreases systemic drug effects even when the i.p. drug dose is increased to cause local toxicity.

5-Fluorouracil chemotherapy and pelvic radiation in the treatment of large bowel cancer. Decreased toxicity in combined treatment with 5-fluorouracil administration through the intraperitoneal route.

Multimodality cancer therapy commonly involves the interactions of surgeon, radiation therapist, and medical oncologist. This prospective study was undertaken to record possible adverse effects of surgery, external beam radiation therapy, and 5-fluorouracil (5-FU) chemotherapy in the treatment of large bowel cancer. The dose of 5-FU by the intraperitoneal (IP) or intravenous (IV) routes was diminished when pelvic radiation therapy was given. The reduction in drug dose that was required was much greater when 5-FU was given IV as compared to IP. The proportion of patients remaining on IV 5-FU chemotherapy was significantly reduced when the patient received pelvic radiation. There was a significant increase in leukopenia and thrombocytopenia when patients received pelvic radiation. Hematologic toxicity was more severe when there was IV compared with IP administration of 5-FU. Pelvic radiation therapy diminished the patient's capacity to receive chemotherapy because of hematologic toxicity. The locoregional administration of 5-FU chemotherapy was better tolerated as part of a multimodality treatment regimen than was systemic administration.

Prospective randomized trial of intravenous v intraperitoneal 5-FU in patients with advanced primary colon or rectal cancer.

No new chemotherapy agents have been developed in the recent past that present hope for improving survival in patients with colon or rectal cancer. This study was undertaken to investigate a new route of administering an old drug, 5-fluorouracil (5-FU). When 5-FU is delivered by the intraperitoneal (IP) route the tolerable dose of drug was markedly increased without an increase in adverse side effects. The natural history of surgically treated disease was changed by reducing the incidence of peritoneal carcinomatosis, but time to relapse and survival was not improved. Intraperitoneal 5-FU may be recommended for investigation in patients with perforated colon cancer, peritoneal implants, or as one part of a multimodality treatment protocol for colorectal cancer. If 5-FU is given to patients with gastrointestinal malignancy, the IP route should be strongly considered.

Prospective, randomized trial of intravenous versus intraperitoneal 5-fluorouracil in patients with advanced primary colon or rectal cancer.

No new chemotherapy agents have been developed recently that present hope for improving survival in patients with colon or rectal cancer. We undertook this study to investigate a new route of administering an old drug, 5-fluorouracil (5-FU). Sixty-six patients with advanced primary colon or rectal cancer were randomized to receive 12 cycles with increasing dosages of intravenous (IV) or intraperitoneal (IP) 5-FU; the mean follow-up time was three years. The maximal tolerable dose and objective adverse side effects were prospectively recorded. The mean daily dose of 5-FU given by the IV route was 904 mg; for the IP route it was 1361 mg (p2 less than 0.0001). Two of ten patients had recurrent peritoneal carcinomatosis when treated with IP 5-FU; ten of eleven patients treated with IV 5-FU developed peritoneal implants (p2 less than 0.003). The incidence of serious complications was the same, but hematologic toxicity and hepatic toxicity were significantly reduced in patients who received IP 5-FU. When 5-FU is delivered by the IP route, the tolerable dose of drug was markedly increased without an increase in adverse side effects. The natural history of surgically treated disease was changed by reducing the incidence of peritoneal carcinomatosis but time to relapse and survival was not improved. IP 5-FU may be recommended for investigation in patients with perforated colon cancer, peritoneal implants, or as one part of a multimodality treatment protocol for colorectal cancer. If 5-FU is given to patients with gastrointestinal malignancy, the IP route should be strongly considered.