The influence of blood volume-controlled ultrafiltration on hemodynamic stability and quality of life.

Dialysis hypotension occurs frequently and is associated with increased morbidity, mortality, and may influence quality of life. We investigated the influence of blood volume (BV)-controlled ultrafiltration on hemodynamic stability and quality of life in a prospective multiple crossover study. Nineteen patients were consecutively treated with standard hemodialysis (HD), BV-controlled ultrafiltration, and again with standard ultrafiltration during 3-week phases, during which different hemodynamic parameters, ultrafiltrate quantities, dry weight, and quality of life were measured. Blood volume-controlled ultrafiltration resulted in increased hemodynamic stability: systolic blood pressure was significantly higher after treatment with BV-controlled HD compared with both standard treatments (p=0.018 and 0.043, respectively). Also, systolic blood pressure reduction, as a measure of blood pressure stability, was significantly smaller during the BV-controlled phase (-3.9 mmHg) compared with both standard phases (-13.7 and -11.0 mmHg): p=0.003 and 0.035, respectively. No difference was found in the occurrence of large decreases of blood pressure (>30 mmHg), decreases below 90 mmHg systolic pressure, or subjective complaints during treatment or after treatment between both treatment modalities. During the course of the study, the dry weight decreased significantly from mean 73.3 to mean 70.9 kg, and the amount of ultrafiltrate was significantly larger using BV-controlled HD compared with standard treatment (mean 2407 vs. mean 2266 mL; p=0.035). Quality of life, measured by visual analog scales (VAS), showed discrete but no consistent differences between study phases. We conclude that BV-controlled HD increases hemodynamic stability and ultrafiltrate amount compared with a standard treatment. No consistent change in quality of life is found between both treatment modalities.

The impact of diagnosis and treatment of rectal cancer on paid and unpaid labor.

PURPOSE: This study was designed to describe the consequences of diagnosis and treatment of rectal cancer for paid and unpaid labor over time and to identify sociodemographic-related factors, treatment-related factors, and quality of life-related factors associated with paid and unpaid labor. METHODS: Data were assessed prospectively in two samples of patients with primary rectal cancer, participating in a multicenter clinical trial, who were randomized to receive surgery with or without 5 x 5-Gy preoperative radiotherapy. For paid labor, 292 patients who indicated paid labor before treatment filled out quality of life questionnaires, which included questions on paid labor at 3, 6, 12, 18, and 24 months after surgery. For unpaid labor, another sample of 92 patients also filled out the Health and Labor questionnaire, which included questions on unpaid labor, before treatment, and at 3 and 12 months after treatment. RESULTS: From 3 to 18 months after surgery, paid labor resumption increased from 19 to 63 percent (P < 0.001). At 24 months after surgery, paid labor resumption was 61 percent. In a multivariate analysis, age older than 55 years (P

Self-reports of health-care utilization: diary or questionnaire?

OBJECTIVES: The feasibility and convergent validity of a cost diary and a cost questionnaire was investigated. METHODS: Data were obtained as part of a cost-utility analysis alongside a multicenter clinical trial in patients with resectable rectal cancer. A sample of 107 patients from 30 hospitals was asked to keep a weekly diary during the first 3 months after surgery, and a monthly diary from 3 to 12 months after surgery. A second sample of seventy-two patients from twenty-eight hospitals in the trial received a questionnaire at 3, 6, and 12 months after surgery, referring to the previous 3 or 6 months. Format and items of the questions were similar and included a wide range of medical and nonmedical items and costs after hospitalization for surgery. RESULTS: Small differences were found with respect to nonresponse (range, 79 to 86 percent) and missing questions (range, 1 to 6 percent between the diary and questionnaire). For most estimates of volumes of care and of costs, the diary and questionnaire did not differ significantly. Total 3-month nonhospital costs were 1,860 Euros, 1,280 Euros, and 1,050 Euros in the diary sample and 1,860 Euros, 1,090 Euros, and 840 Euros in the questionnaire sample at 3, 6, and 12 months after surgery, respectively (p = .50). However, with respect to open questions, the diary sample tended to report significantly more care. CONCLUSIONS: For the assessment of health-care utilization in economic evaluations alongside clinical trials, a cost questionnaire with structured closed questions may replace a cost diary for recall periods up to 6 months.

Impact of short-term preoperative radiotherapy on health-related quality of life and sexual functioning in primary rectal cancer: report of a multicenter randomized trial.

BACKGROUND: Few prospective studies have been performed about the impact of preoperative radiotherapy (PRT) or total mesorectal excision (TME) on health-related quality of life (HRQL) and sexual functioning in patients with resectable rectal cancer. This report describes the HRQL and sexual functioning of 990 patients who underwent TME and were randomly assigned to short-term PRT (5 x 5 Gy). PATIENTS AND METHODS: The Rotterdam Symptom Check List supplemented with additional items was used with questionnaires before treatment and at 3, 6, 12, 18, and 24 months after surgery. Patients without a recurrence the first 2 years were analyzed (n = 990). RESULTS: Few differences were found in HRQL between patients treated with or without PRT. Daily activities were significantly less for PRT patients 3 months postoperatively. Irradiated patients recovered slower from defecation problems than TME-only patients (P = .006). PRT had a negative effect on sexual functioning in males (P = .004) and females (P < .001). Irradiated males had more ejaculation disorders (P = .002), and erectile functioning deteriorated over time (P < .001). PRT had similar effects in patients who underwent a low anterior resection (LAR) versus an abdominoperineal resection (APR). Patients with an APR scored better on the physical (P = .004) and psychologic dimension (P = .007) than LAR patients, but worse on voiding (P = .0007). CONCLUSION: Short-term PRT leads to more sexual dysfunction, slower recovery of bowel function, and impaired daily activity postoperatively. However, this does not seriously affect HRQL. The comparison between LAR and APR patients demonstrates that the existence of a permanent stoma is not the only determinant of HRQL.

Clinical nature and prognosis of locally recurrent rectal cancer after total mesorectal excision with or without preoperative radiotherapy.

PURPOSE: To document the clinical nature and prognosis of locally recurrent rectal cancer after total mesorectal excision (TME) with or without 5 x 5 Gy preoperative radiotherapy (PRT) and to identify patient-, disease-, and treatment-related factors associated with differences in prognosis after local recurrence. PATIENTS AND METHODS: For 96 Dutch patients with a local recurrence who participated in a multicenter randomized clinical trial, data on treatments and follow-up were gathered from surgeons and radiation and medical oncologists. Twenty-three patients (24%) had previously been treated with PRT plus TME, and 73 patients (76%) had been treated with TME alone. Eighty-one patients (84%) were followed until death; median follow-up time of the alive patients after local recurrence was 21 months (range, 5 to 48 months). RESULTS: Survival after local recurrence in the PRT + TME group was significantly shorter than in the TME group (median survival, 6.1 v 15.9 months; hazard ratio for death, 2.1; P =.008). Patients with a local recurrence in the PRT + TME group had distant metastases more often (74% v 40%; P =.004), underwent surgical resection of local recurrence less often (17% v 35%; P =.11), and received radiotherapy for local recurrence at a total dose >/= 45 Gy less often (4% v 42%; P =.001) than patients without PRT. In a multivariate analysis, the difference in survival after local recurrence between randomization groups was no longer statistically significant (hazard ratio for death of PRT, 1.53; P =.16). CONCLUSION: The clinical nature and prognosis of patients with locally recurrent rectal cancer has changed since the introduction of PRT. The majority of patients who present with a local recurrence after previous PRT have simultaneous distant metastases, and median survival has decreased to 6 months.

Cost measurement in economic evaluations of health care: whom to ask?

PURPOSES: The purposes of this study were 1) to investigate the feasibility of using providers' administrative systems for the assessment of healthcare utilization in economic evaluations performed alongside multicenter studies, 2) to assess the convergent validity of patients' and providers' reports of care, and 3) to investigate whether differences between providers' and patients' reports are related to age, gender, health, recall period, and volumes of care. METHODS: Data were obtained as part of a cost-utility analysis alongside a multicenter clinical trial in patients with rectal cancer. For a sample of 179 patients from 49 hospitals, data on hospitalizations, outpatient visits, medications, and care products during the first year after treatment were obtained from the patients by questionnaire or diary. For all patients, hospitals were contacted for information on hospitalizations and outpatient visits. For a subsample of 94 patients, 86 pharmacists and 10 suppliers of stoma care products were contacted for information on medications and care products. RESULTS: Response by providers of care was high, ranging from 84% to 100%. With respect to hospital days and outpatient visits, we found no significant differences between patients' and providers' reports. For medications and care products, agreement was lower, with providers reporting up to 2 times more product types and costs than patients. Providers failed to report 20% to 25% of all products, whereas patients failed to report 50% to 60% of all products. CONCLUSIONS: Patients' reports seem as valid as providers' reports for hospital days and outpatient visits. For medications and care products, we recommend the use of reports from providers of care, whenever feasible, because they much less underestimate volumes and costs than patients.

Cost-utility analysis of preoperative radiotherapy in patients with rectal cancer undergoing total mesorectal excision: a study of the Dutch Colorectal Cancer Group.

PURPOSE: To compare the societal costs and the (quality-adjusted) life expectancy of patients with rectal cancer undergoing total mesorectal excision (TME) with or without short-term preoperative radiotherapy (5 x 5 Gy). PATIENTS AND METHODS: We used a Markov model to project the clinical and economic outcomes of preoperative radiotherapy. Data on local recurrence rates, quality of life, and costs were obtained from the patients of a multicenter randomized clinical trial. In this trial, 1,861 patients with resectable rectal cancer from 108 hospitals were randomly assigned for TME surgery with or without preoperative radiotherapy. Outcome measures of the model were life expectancy, quality-adjusted life expectancy, lifetime costs per patient, and the incremental cost-effectiveness ratio. RESULTS: The base case model estimates that the loss of quality of life due to preoperative radiotherapy is outweighed by the gain in life expectancy. Life expectancy increases by 0.67 years; quality-adjusted life expectancy, by 0.39 years; and costs, by $9,800 per patient. The corresponding cost-effectiveness ratio is $25,100 per quality-adjusted life year. Sensitivity analyses indicate that the cost-effectiveness ratio remains acceptable under a wide range of assumptions. CONCLUSION: Assuming that the reduced local recurrence rate does lead to a survival advantage, the cost-utility analysis estimates that the improved survival outweighs the impaired quality of life and the increased costs. We conclude that short-term preoperative radiotherapy in patients with rectal cancer undergoing TME is both effective and cost-effective.