Measuring clients' satisfaction with self-help agencies

OBJECTIVE: Clients' satisfaction with their involvement in treatment decisions has been largely overlooked in the formulation of satisfaction measures. The authors describe the development of a scale that assesses clients' satisfaction with services and with their involvement in treatment decisions. METHODS: Long-term users of four client-operated mental health self-help agencies were interviewed at baseline (N=310) and six months (N=248) using the 11-item Self-Help Agency Satisfaction Scale (SHASS). The scale was developed on the basis of consumers' input about their satisfaction with services and their involvement in treatment decisions. To explore the relationship between satisfaction as measured by the SHASS and outcomes, the six-month interview included four outcome measures-independent and assisted social functioning, symptom severity, and a sense of personal empowerment. Internal consistency, stability, and discriminant validity were evaluated. RESULTS: Factor analyses confirmed that the SHASS has two subscales, one assessing service satisfaction and the other assessing satisfaction with involvement in treatment decisions. The scale and its subscales showed high internal consistency, moderate stability, and discriminant validity. The SHASS subscales showed modest associations with two of four outcome measures-assisted and independent social functioning. CONCLUSIONS: The SHASS is a brief instrument that can be used to measure clients' satisfaction with their involvement in treatment in mental health self-help agencies.     

Risk management strategies in the postmarketing period : safety experience with the US and European bosentan surveillance programmes.

In view of the shortcomings of the current system for postmarketing drug surveillance that is based on voluntary spontaneous adverse drug reaction (ADR) reporting, new approaches are needed.We describe an approach involving a combination of limited distribution, patient and physician education, as well as a novel pharmaco-vigilance system that is capable of promoting the safe and adequate use of a new drug. Importantly, it provides the possibility of calculating true ADR occurrence rates, as the exposed population (denominator) and the number of patients with events (numerator) are known. These measures were taken for the oral dual endothelin ET(A)/ET(B) antagonist bosentan (Tracleer). In recent guidelines issued by the European Society of Cardiology, American College of Chest Physicians and the WHO, this drug is considered as first-line oral treatment for the treatment of pulmonary arterial hypertension, a devastating orphan disease associated with a poor prognosis. Bosentan was approved in 2001/2 on the basis of two pivotal studies that showed improved exercise capacity and haemodynamic parameters while delaying time to clinical worsening. Elevations in serum liver aminotransferase levels of >3 times the upper limit of normal were noted in 10.2% of patients (placebo-subtracted incidence). Therefore, liver function tests have to be performed on a regular basis. In addition, bosentan has potential as a teratogen.In the US, a controlled distribution network for bosentan (Tracleer) Access Program [T.A.P.]) and the development of a patient database to follow patients was set up. Accompanied by comprehensive physician and patient education programmes, T.A.P. was developed to provide a mechanism to assist with the primary risk management goals for bosentan therapy, namely pregnancy prevention and liver enzyme monitoring and prevention of hepatic injury.In Europe, the Tracleer) Excellence (TRAX PMS) database is a novel European non-interventional, prospective, internet-based surveillance system initiated by the manufacturer in cooperation with the European Medicines Agency. It collected potential safety signals associated with bosentan use including adverse events, elevations of liver aminotransferase levels, other abnormal laboratory values, death and hospitalisation. TRAX PMS has accrued 79% of all known patients in the EU and the data provide supportive 'real-life' evidence on the long-term safety of bosentan.The two different systems had similar goals and outcomes. The data received concerning thousands of patient-years of use have confirmed the clinical trial results regarding product safety and the favourable benefit/risk ratio of bosentan, especially with regard to known type A adverse events. The clinical monitoring algorithm has also been confirmed. In addition, no rare type B events were uncovered despite the increased reporting rate. These systems might serve as templates for future pharmaco-vigilance efforts regarding drugs that require particular safety attention.     

The experience of application of peritoneal dialysis in cardiosurgery of an early age children

The experience of the peritoneal dialysis (PD) successful application in 16 children of an early age was summarized. In all the patients the terminal state with an acute cardiac and renal insufficiency was noted after cardiosurgical operation conduction using artificial blood circulation. The improvement of hemodynamical indices, renal and pulmonary function as well, were promoted by an early application of PD.     

Further observations on social factors associated with duodenal ulcer in Soweto

It has been postulated that urbanisation is an important factor in the genesis of duodenal ulcer. This study of 100 duodenal ulcer patients, and 100 hospital controls, matched according to sex, age, education and occupation, and an additional 50 unmatched endoscopically negative controls, confirmed that duodenal ulcer patients were mainly young men who were more likely to have been born in an urban area than the controls. Furthermore, a significant number of duodenal ulcer patients were born and reared in the smaller towns of South Africa and then moved to Soweto. It is suggested that frustrated aspirations in these towns might even be greater than in Soweto. In the context of the Soweto population where occupational and educational status is generally low, duodenal ulcer patients were of a higher educational and occupational category than Sowetans and unselected controls. Thus factors associated with urbanisation such as education and occupation and the pattern of urbanisation play key roles in duodenal ulcer. Investigation into particular aspects of the work situation such as the degree of autonomy exercised at work, authority over others and attitudes to supervision yielded no significant results.     

Low endometrial volume may predict early pregnancy loss in women undergoing in vitro fertilization

PURPOSE: To evaluate the role of 3-D US measurement of the endometrium during early IVF-pregnancy and before the appearance of gestational sac in the prediction of pregnancies outcome. METHODS: 60 pregnant women following IVF treatment were included in the study. The women underwent transvaginal 3D US measurements of endometrial volume and thickness on day 15-17 post ET. Patients were followed and classified according to pregnancy outcome into 2 further groups. The group with early pregnancy loss and the group with ongoing pregnancy. RESULTS: While no differences were observed between those who miscarried and those who did not in gestational age, endometrial thickness or volume, spontaneous early pregnancy loss was significantly higher in patients with endometrial volume <2 mL as compared to those with endometrial volume >2 mL. CONCLUSIONS: 3-D US measurement of endometrial volume of less than 2 mL during early IVF pregnancy and prior to the appearance of gestational sac is a powerful predictor of pregnancy loss.     

The effect of thyroid status on the calmodulin content of several tissues in the rat

The present studies represent an initial effort to evaluate a possible relationship between thyroid status and calmodulin and were undertaken because of evidence that some actions of the thyroid hormones are calmodulin mediated. To this end, the effects of hypothyroidism and of thyroid hormone excess on the concentration of calmodulin in several tissues of the rat were evaluated. In thymocytes, liver, heart, and brain, but not in skeletal muscle, calmodulin concentrations were markedly increased in the thyrotoxic rat (140-203% of values in normal controls); values were unchanged in hypothyroid animals. These changes were evident regardless of whether calmodulin concentrations were expressed per cell (thymocytes), or in relation to either the wet wt or protein content of the tissues. These findings are apparently the first to demonstrate that thyroid hormone, unlike other hormones tested thus far, can influence tissue calmodulin content. In view of the fact that many metabolic systems that are influenced by calmodulin are similarly affected by thyroid hormones, the findings support the possibility that some actions of thyroid hormone are calmodulin mediated.     

Avascular necrosis after treatment of DDH: the protective influence of the ossific nucleus

We retrospectively reviewed the results of open or closed reduction for developmental dysplasia of the hip (DDH) in 49 children younger than 12 months old, who had 57 hip dislocations. Group A (18 hips) developed partial or complete avascular necrosis (AVN), and group B (39 hips) did not develop AVN. Thirty-eight hips were treated by closed reduction, and 17 had open reduction. One patient with bilateral hip dislocation initially had closed reductions followed by bilateral open reduction 3 months later. With the numbers available for study, there was no significant difference in the occurrence of AVN with respect to variables such as preliminary traction, closed versus open reduction, Pavlik harness use, and age at the time of operative intervention. However, the presence of the ossific nucleus before reduction, detected either by radiographs (p < 0.001) or ultrasonography (p = 0.033) was statistically significant in predicting AVN. Only one (4%) of 25 hips with an ossific nucleus developed AVN, whereas 17 (53%) of 32 hips without an ossific nucleus before reduction developed AVN. Our results suggest that the presence of the ossific nucleus before closed or open reduction for DDH may decrease the risk of AVN.