Post-conference session: Experience with patient self-management of oral anticoagulation

Long-term oral anticoagulation requires careful patient monitoring in order to optimize results and to limit hemorrhagic or thromboembolic complications of treatment. For this reason, any improvement in anticoagulant control and management can be expected to have far-reaching consequences in extending longevity and decreasing complications in anticoagulated patients after heart valve surgery. Because one attractive means of improving anticoagulant management is to give patients a share of the responsibility, a program was designed to encourage patients to take an active role in monitoring their own prothrombin time (PT) and managing their own oral anticoagulation. During the period from August 1986 to February 1992, 600 patients requiring long-term anticoagulation, mainly after heart valve replacement, were trained to measure their own PT at the Cardiac Rehabilitation Center (Herz-Krauslauf-Klinik, Bad Berleburg, Germany) and to manage their own therapy: 216 patients could be followed with regard to their self-determined prothrombin times. The results were within the target range in 83.1% of the PT determinations (n=12,306 measurements) taken by the patients themselves. Neither major bleeding nor thromboembolic complications were observed in 205 patient-years of self-monitoring of PT and self-management of oral anticoagulation.     

A prospective evaluation of changes in neuropsychological and liver function tests following transjugular intrahepatic portosystemic stent-shunt

Background/Aims: This study was designed to assess changes in: (a) neuropsychological tests, measures of memory, quality of life and scores for anxiety and depression; (b) liver function tests; and (c) the relationship between these following transjugular intrahepatic portosystemic stent-shunt.Methods: Twenty-nine patients undergoing transjugular intrahepatic portosystemic stent-shunt for recurrent variceal haemorrhage, 12 matched patients with cirrhosis and variceal haemorrhage manage with variceal band ligation and 16 normal controls were studied. Patients in any of the groups who were clinically encephalopathic were excluded from the study. Serial changes in the conventional liver function tests and Indocyanine green clearance, and psychometric function (Hospital Anxiety Depression Scale, Rivermead Behavioral Memory Test, Quality of Life and the memory and reaction sub-tests of the Cambridge Automated Neuropsychological Test Assessment Battery) were measured prior to and 1, 3, 9 and 15 months following transjugular intrahepatic portosystemic stent-shunt.Results: Over a mean follow up of 9.1 months in the transjugular intrahepatic portosystemic stent-shunt group (range 3–28), one patient (3%) developed clinically detectable encephalopathy. Sixty-seven percent of patients with cirrhosis showed evidence of subclinical encephalopathy as compared with the control population. Significant deterioration occurred in the reaction sub-tests of the Cambridge Automated neuropsychological Test Assessment Battery in patients, both in the transjugular intrahepatic portosystemic stent-shunt group and the controls with cirrhosis, during follow up. Transjugular intrahepatic portosystemic stent-shunt was followed by significant deterioration in levels of anxiety and psychological component of the quality of life. The Rivermead Behavioural Memory Test and the memory sub-test of the Cambridge Automated Neurpsychological Test Assessment Battery did, however, improve significantly at 1 and 15 months after transjugular intrahepatic portosystemic stent-shunt, respectively. Serum alanine aminotransferase, bilirubin and indocyanine green clearance deteriorated significantly following transjugular intrahepatic portosystemic stent-shunt (p<0.001, p<0.001 and p<0.0001, respectively). Significant correlation was observed between changes in the indocyanine green clearance and changes in the complex and simple reaction time subtests of the Cambridge Automated Neuropsychological Test Assessment Battery (r=0.6 and r=0.66, respectively).Conclusions: The results of this study showed that about 67% of patients with cirrhosis were subclinically encephalopathic and that temporary deterioration occurred in the Cambridge Automated Neuropsychological Test Assessment Battery during follow up, both in patients having transjugular intrahepatic portosystemic stent-shunt and in the controls with cirrhosis. These parallel the changes in the liver function tests and indocyanine green clearance. Temporary deterioration was also observed in the Quality of Life and Hospital Anxiety Depression Scale in the transjugular intrahepatic portosystemic stent-shunt group, although the measures of memory improved. Further studies should address the biochemical mechanisms of these changes and the role of prophylactic measures.     

Abnormal behavior of elderly people residing in institutions of medical and social welfare systems

Abstract We investigated factors correlated with abnormal behavior in the elderly residing in a special nursing home (group A) and a psychiatric hospital (group B) using the dementia behavior disturbance scale, the mini mental state examination, the Japanese version of the Philadelphia Geriatric Center morale scale, and the ADL assessment scale. The cognitive function of group B was decreased compared with that of group A, but most activities of daily living (ADL) in the latter group were disrupted compared with those in the former. Only a few categories of ADL correlated with abnormal behavior in group A, whereas cognitive function, quality of life, and most categories of ADL correlated with abnormal behavior in group B. These results suggest that factors correlated with abnormal behavior in the elderly differ within institutions of medical and social welfare systems.     

An Intrapleural Lung Prosthesis: Rationale, Design, and Testing

Abstract: Extracorporeal life support (ECLS or ECMO) is standard treatment for severe respiratory failure but poses many contraindications to future lung transplantation. The solution to this dilemma is the implantable gas exchange device (IGED) or artificial lung. Preliminary efforts to create such an artificial lung have been made since 1970 and include designs involving single devices, intravascular devices (i. e., IVOX), and combination heart–lung devices, Stringent requirements govern the design of such a device, the most important of which are high gas exchange efficiency, low resistance to blood flow, and size. This paper describes such a device. It incorporates large diameter inflow and outflow ports in close proximity and a low resistance wound hollow fiber core encapsulated in a compliant outer shell which conserves the work of the right ventricle. In a large animal model (adult sheep) this device was connected in line with the main pulmonary artery in series with the native lungs. This configuration has the advantages of using the lungs as an embolic filter, perfusing the lungs with fully oxygenated blood, and maintaining the integrity of the anatomy necessary for transplant. Laboratory experiments have run >8 h. Preliminary data show that the animals have remained hemodynamically stable while the devices have supported the animals completely by supplying 100% O₂ saturation with PO₂ values ranging from 250–350 mm Hg. Additionally, this model makes possible the study of respiratory failure without introducing other variables such as extracorporeal circuits or pumps. The other metabolic, endocrine, and reticuloendothelial functions of normal and injured lungs can now be studied more precisely by excluding these variables. Further studies are needed to evaluate this device in chronic (long–term implantation) experiments before clinical application.     

Met and unmet nursing care needs in men with prostate cancer. An explorative study. Part II

Men with prostate cancer ( n = 11) were interviewed during an in-patient period at a urological clinic, about their experiences of met and unmet needs from health professionals. Their perception of quality of life and sense of coherence were also assessed. The findings were analysed from a phenemenological-hermeneutic perspective and interpreted within the concept of transition. It was interpreted that objective functional health needs were mostly met by health professionals and subjective existential needs were mostly not met. The analysis revealed patients as passive or active receivers of care. Passive receivers were explicitly and implicitly stating unmet needs, or explicitly stating satisfaction with nursing care at the same time as implicitly contradicting, referring to their needs as bagatelles, unimportant, whereas active receivers talked about their needs explicitly with the staff and did not state implicit unmet needs. This suggests that nurses need to be aware of and have sensitive ears to undertones in statements and actively seek for patients' needs. The most important nursing care areas seemed to be to provide solutions to physical problems together with staff support including information, and acting to increase confidence in staff and staff availability. This encourages patients, wives and families, in co-operation, towards a healthy exit of transition.     

Changes over 6-months in health-related quality of life in a matched sample of hispanics and non-hispanics with heart failure

Hispanics are a growing ethnic minority in the United States and one at significant risk for heart failure. Health-related quality of life (HRQL) is poor in individuals with heart failure, especially during and immediately following hospitalization. No prior research into the HRQL of Hispanics with heart failure was located. A sample of 80 individuals with heart failure, evenly divided by primary language and matched on functional status using the New York Heart Association classification system and age, was studied for 6 months following hospital discharge. Data on HRQL were collected using Spanish and English versions of the Minnesota Living with Heart Failure Questionnaire. Scores improved over time in both groups but significantly more so in the Hispanics when compared to the non-Hispanics. Group differences in HRQL could not be explained by demographics, clinical characteristics, treatment received, perceived support, or instrument response characteristics. Further exploration of this naturally occurring phenomenon may provide insight into how HRQL can be improved in the general heart failure population.     

Quality of life research in patients with rectal cancer: traditional approaches versus a problem-solving oriented perspective

The present paper critically appraises two recent overviews of the literature on rectal cancer and quality of life (QL). These reviews focus on the Anglo-American literature, largely neglect research from other countries, and provide little stimulus regarding future research directions. As an alternative perspective we propose the concept of problem-solving oriented QL research. The major theme is that the QL concept must be integrated into the clinical arena. To begin with, QL researchers must make themselves understandable. We outline several ways in which this can be achieved: (a) placing QL in a broader concept together with outcomes that are more familiar to clinicians; (b) depicting individual patients in the form of QL profiles; (c) clarifying the psychosocial/clinical correlates of particular QL scores of interest; and (d) conducting studies with a definitive practical goal in mind and integrating practitioners and patients into the study group. We illustrate the feasibility of such a research program by performance data from our Marburg-Biedenkopf field trial. Pursuing an ambitious research strategy that integrates experimental and applied research, the QL movement will have the chance to show that it is not merely l'art pour l'art, but indeed is beneficial to society. Received: 28 September 1998 / Accepted: 14 October 1998     

Intellectual property considerations in the development and use of HRQL measures for clinical trial research

As a result of the expanded use of health-related quality of life (HRQL) measures in clinical trial research, a variety of legal and ethical issues have surfaced. These issues can be put in the form of the following questlons: (1) Under what circumstances should access to HRQL measures be restricted? (2) Under what circumstances is it appropriate for the developers of HRQL measures to assert their intellectual property rights to the instruments? (3) Under what circumstances is personal profit from the sale and use of HRQL measures legally and socially appropriate? Access to HRQL research is to be encouraged since this is necessary for this field to progress. However, the need for protection against misuse of ongoing work is real and may justify the assertion of intellectual property rights. HRQL measures developed entirely with public monles should remain in the public domain or be managed for the public good. Instruments developed with private funds or with a mix of public and private funds should be treated in a manner that refiects a fair balance between the rights of the private developer and those of the scientific community and the public. HRQL questionnaires are regularly being refined; such work is costly. Investigators continuing research directly related to instrument refinement might reasonably ask for compensation from those who wish to use their work.