Distinguishing benign and malignant pelvic masses: the value of different diagnostic methods in everyday clinical practice.

OBJECTIVE: To optimize referral to specialized gynaecologists for surgical treatment of ovarian cancer by improving preoperative discrimination between benign and malignant pelvic tumours. STUDY DESIGN: In a prospective multicentre study 143 patients with a pelvic mass were included. At several occasions during the diagnostic work-up the gynaecologist estimated the chance of malignancy (educated guess/expert opinion). MRI in the local setting was suggested for uncertain cases. All MRI images were reviewed by an expert radiologist. The datasheet designed for the study further allowed for determining the risk of malignancy index (RMI). RESULTS: The diagnostic accuracy of the gynaecologist's final estimation of the chance of malignancy and the calculated RMI were comparable (area under the ROC curve of 0.87 and 0.86). MRI did not improve the accuracy of the diagnostic work-up for the study population as a whole. Subgroup analysis did however show improved diagnostic accuracy in cases with an estimated chance of malignancy between 20 and 80% when the MRI was read by an expert radiologist. CONCLUSION: Patient selection for surgery of a pelvic mass should be based on the chance of malignancy as assigned by the referring gynaecologists. In case of uncertainty MRI improves diagnostic accuracy, when judged by an expert.

Prospective study of long-term impact of adjuvant high-dose and conventional-dose chemotherapy on health-related quality of life.

PURPOSE: To evaluate and compare health-related quality of life (HRQOL) after conventional- and high-dose adjuvant chemotherapy in patients with high-risk breast cancer. PATIENTS AND METHODS: Patients were randomly assigned to either a conventional or high-dose chemotherapy regimen; both regimens were followed by radiotherapy and tamoxifen. HRQOL was evaluated until disease progression using the Short Form-36 (SF-36), Visual Analog Scale, and Rotterdam Symptom Checklist and assessed every 6 months for 5 years after random assignment. For the SF-36, data from healthy Dutch women with the same age distribution served as reference values. RESULTS: Eight hundred four patients (conventional-dose chemotherapy, n = 405; high-dose chemotherapy, n = 399) were included. Median follow-up time was 57 months. Directly after high-dose chemotherapy, HRQOL decreased more compared with conventional chemotherapy for all SF-36 subscales. After 1 year, the reference value of healthy women was reached in both groups. Small differences were observed between the two groups in the role-physical and role-emotional subscales, but 1 year after treatment, these differences were minor and not clinically relevant. During follow-up, patients with a lower educational level and many complaints before chemotherapy experienced a worse HRQOL. CONCLUSION: Shortly after high-dose chemotherapy, HRQOL was more affected than after conventional-dose chemotherapy. One year after random assignment, differences were negligible. Identifying patients who have a higher chance of persistent impaired quality of life after treatment (which, in the present study, included patients with a lower educational level and many complaints before chemotherapy) is important and may open the way for better patient-tailored prevention strategies.

Fatigue and relating factors in high-risk breast cancer patients treated with adjuvant standard or high-dose chemotherapy: a longitudinal study.

PURPOSE: Determine whether standard or high-dose chemotherapy leads to changes in fatigue, hemoglobin (Hb), mental health, muscle and joint pain, and menopausal status from pre- to post-treatment and to evaluate whether fatigue is associated with these factors in disease-free breast cancer patients. PATIENTS AND METHODS: Eight hundred eighty-five patients were randomly assigned between two chemotherapy regimens both followed by radiotherapy and tamoxifen. Fatigue was assessed using vitality scale (score < or = 46 defined as fatigue), poor mental health using mental health scale (score < or = 56 defined as poor mental health) both of Short-Form 36, muscle and joint pain with Rotterdam Symptom Checklist, and Hb levels were assessed before and 1, 2, and 3 years after chemotherapy. RESULTS: Fatigue was reported in 20% of 430 assessable patients (202 standard-dose, 228 high-dose) with at least a 3-year follow-up, without change over time or difference between treatment arms. Mean Hb levels were lower following high-dose chemotherapy. Only 5% of patients experienced fatigue and anemia. Mental health score was the strongest fatigue predictor at all assessment moments. Menopausal status had no effect on fatigue. Linear mixed effect models showed that the higher the Hb level (P = .0006) and mental health score (P < .0001), the less fatigue was experienced. Joint (P < .0001) and muscle pain (P = .0283) were associated with more fatigue. CONCLUSION: In 3 years after treatment, no significant differences in fatigue were found between standard and high-dose chemotherapy. Fatigue did not change over time. The strongest fatigue predictor was poor mental health.

Reliability and validity of the (modified) Amsterdam Inventory for Auditory Disability and Handicap.

This study investigated the psychometric adequacy of the (modified) Amsterdam Inventory for Auditory Disability and Handicap ((m)AIAD). The original version of the AIAD was developed by Kramer et al in 1995. Special emphasis was placed on the statistical aspects of the scores, because these properties place limits on the clinical utility of the instrument. The AIAD is a self-assessment questionnaire that consists of 30 questions covering all the relevant factors of disability in individual hearing functioning in daily life. This paper reports data from 94 subjects, aged 17-65 years, with different hearing abilities, who completed a modified version of the AIAD and the Hearing Disability Questionnaire (HDQ), on two occasions 1 month apart. The psychometric adequacy of the AIAD was determined by measuring its reliability and validity. Factor analysis was performed, and the reliability was tested by measuring internal consistency, split-half correlation, and test-retest reproducibility. The validity was tested by measuring construct and criterion validity. The results showed that the reliability of the (m)AIAD was highly satisfactory, with good internal consistency, high split-half correlations, and high test-retest correlations. Construct validity showed a high correlation between scores on the (m)AIAD and scores on the HDQ. Criterion validity showed a moderate but significant correlation between scores on the (m)AIAD and hearing thresholds in dB HL.

The cost effectiveness of lung transplantation compared with that of heart and liver transplantation in the Netherlands.

This study was performed to assess the main reasons for the unfavorable cost effectiveness of lung transplantation compared with that of heart and liver transplantation. Costs, effects, and cost-effectiveness ratios of Dutch lung, heart, and liver transplantation programs were compared. The data are based on three Dutch technology assessments of transplantation, with minor adjustments for time and methods. In result, mainly follow-up costs of lung transplantation are higher than costs of heart and liver transplantation-- 50,300 US dollars, 121,500 US dollars, and 95,300 US dollars, respectively--in the first 3 years after transplantation. The survival gain realized by lung transplantation is small (4.4 years) compared with heart (8.8 years) and liver (14.7 years) transplantation. Costs per life-year gained were 77,000 US dollars, 38,000 US dollars, and 26,000 US dollars for lung, heart, and liver transplantation, respectively. The unfavorable cost effectiveness of lung transplantation is largely related to a relatively small survival gain and high follow-up costs.

Selective decontamination of the digestive tract to prevent postoperative infection: a randomized placebo-controlled trial in liver transplant patients.

OBJECTIVE: To determine the efficacy of selective decontamination of the digestive tract (SDD) in patients undergoing elective transplantation of the liver. DESIGN: Randomized, double-blind, placebo-controlled study. SETTING: Two academic teaching hospitals. PATIENTS: Adult patients undergoing elective liver transplantation: 26 patients receiving SDD and 29 patients receiving a placebo. INTERVENTIONS: Patients undergoing SDD were administered 400 mg of norfloxacin once daily as soon as they were accepted for transplantation. Postoperative treatment for this group consisted of 2 mg of colistin, 1.8 mg of tobramycin, and 10 mg of amphotericin B, four times daily, combined with an oral paste containing a 2% solution of the same drugs until postoperative day 30. Prophylactic intravenous administration of antibiotics was not part of the SDD regimen in this study. Control patients were given a similar regimen with placebo drugs. MEASUREMENTS: The mean number of postoperative bacterial and fungal infections in the first 30 days after transplantation was the primary efficacy end point. Days on a ventilator, days spent in the intensive care unit, and medical costs were registered as secondary outcome variables. MAIN RESULTS: Of the 26 patients undergoing SDD, 22 (84.5%) developed an infection in the postoperative study period; in the placebo group (n = 29), these numbers were not significantly different (25 patients, 86%). The mean number of postoperative infectious episodes per patient was also not significantly different: 1.77 (SDD) vs. 1.93 (placebo). Infections involving Gram-negative aerobic bacteria and Candida species were significantly less frequent in patients receiving SDD (p <.001 and p <.05). Total costs were higher in the group receiving SDD. CONCLUSIONS: Selective decontamination of the digestive tract does not prevent infection in patients undergoing elective liver transplantation and increases the cost of their care. It does, however, affect the type of infection. Infections with Gram-negative bacilli and with Candida species are replaced by infections with Gram-positive cocci.