Subjective well-being is a major aspect of quality of life and is therefore increasingly used as an endpoint in clinical trials. It is influenced to a great extent by the complex process of coping with the disease and its treatment. Assessment of coping is methodologically demanding, especially in large clinical trials. We therefore developed a single-item measure, the Perceived Adjustment to Chronic Illness Scale (PACIS), as an indicator of coping, complementary to other scales related to quality of life. We sought to validate this instrument in a subgroup of 121 Swiss patients participating in the International Breast Cancer Study Group (IBCSG) adjuvant trials. At months 3 and 6 of adjuvant treatment PACIS showed a distinct pattern of highly significant rank correlations with several disease- and treatment-related problem areas from the Herschbach coping inventory (FBBK); 42% of the variance of PACIS at month 3 was explained by the FBBK (P = .0001). The portion of explained variance was considerably higher for the Italian- (70%) than for the German-speaking (30%) subgroups. Patients who rated more effort to cope with their disease on PACIS indicated more frequent use of 3 of 15 coping strategies in relation to psychological distress. These were "crying and becoming desperate", "taking tranquillizers and alcohol" and "other people are far worse off". These three coping strategies may define a high-risk group for poor psychosocial outcome. Patients whose PACIS scores showed that it required less effort to cope tended to use the strategy "seeing a positive side of the problem". We conclude that PACIS can be used as a global indicator of the coping process in large multicultural clinical trials of adjuvant therapy for breast cancer.
The informed consent procedure applied was satisfactory from a quantitative point of view, and the main items of information were acceptable to the patients. Meerweins's model proved to be applicable and useful for identifying pitfalls in communication. Greater attention should be paid to the indirect messages and implied criticisms of the patients to improve their participation in decision making. Physicians should become more skillful in providing adequate information and improve their methods of communication.
Informing patients on the option of receiving an investigational treatment within a phase I study is feasible and can be done in a way felt appropriate by patients and relatives, nursing and medical professionals. Providing information in an appropriate manner does not increase patients' anxiety and depression. Divergence between the aims and interests of the investigators and patients might explain the difference in the evaluation of physician, a problem which could perhaps be partially overcome by the application of innovative phase I designs.
The awareness of the diagnostic difficulty and the documented high mortality risk of perioperative myocardial infarction (PMI) has led to the wide use of work up to rule out PMI after major noncardiac operations. This has caused stable postoperative patients to be kept in monitored hospital beds for extended periods of time and to be subjected to additional tests. We hypothesized that the mortality of PMI is high and, therefore, the wide use of postoperative work up to identify these patients is justifiable. We performed the following study to prove our hypothesis. All patients in the recovery room after major noncardiac operations who underwent work up to rule out PMI were identified and followed. The PMI work up included care in an electronically monitored unit, physical assessment, continuous ECG monitoring, and three 12-lead electrocardiograms and cardiac enzymes obtained at six to eight hour intervals. Data collection included patient demographics; preoperative cardiac risk factors; incidence of intraoperative hypotension, hemorrhage and ECG changes; type of anesthesia and operative procedures and their durations; postoperative ECG and cardiac enzyme results; the incidence of PMI and patient outcome.Two hundred patients were studied; 85 males and 115 females. Their mean age was 62.9 years. Preexisting conditions included hypertension in 162 patients, peripheral arterial disease in 102, diabetes mellitus in 97, angina in 30, previous myocardial infarction in 41, and smoking in 107. Of 200 patients, 164 had an abnormal preoperative ECG. Vascular operations were performed in 104 patients, nonvascular abdominal operations in 48, and other operations in the remaining 48. Intraoperatively, hypotension occurred in 29 patients, blood loss of >500 ml in 25 and ECG changes in 10. There were no deaths. PMI occurred in 5/200 (2.5%) patients. Four had undergone vascular operations and one had had an abdominal operation. The mean age of the patients with PMI was 64.2 years. The duration of operation and blood loss were similar to those of patients without PMI. None of these patients developed cardiac failure or cardiogenic shock and none of them died.
Conclusion:The incidence of PMI among patients undergoing noncardiac surgery is low and its mortality is negligible. Physicians should become more selective in the use of monitored beds and in the ordering of a work up to rule out PMI. Technology, Pauwelsstrasse. 30, D-52057, Aachen, Germany Aims: To study the relationship between myocardial release of cTnI and myocardial cell death as assessed by the amount of apoptosis and necrosis after cardiac surgery.
Methods:Eighteen young pigs were operated on with standardized cardiopulmonary bypass (CPB). Release of cTnI in the cardiac lymph (CL), coronary sinus (CS), and arterial blood (A) was related to postoperative myocardial cell death by both necrosis and apoptosis. Apoptotic cells were detected by a TUNEL detection kit. Necrotic cells were counted by light microscopy.
Results:In all animals, cTnI was significantly relea...
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