Results of European post-marketing surveillance of bosentan in pulmonary hypertension.

After the approval of bosentan for the treatment of pulmonary arterial hypertension (PAH), European authorities required the introduction of a post-marketing surveillance system (PMS) to obtain further data on its safety profile. A novel, prospective, internet-based PMS was designed, which solicited reports on elevated aminotransferases, medical reasons for bosentan discontinuation and other serious adverse events requiring hospitalisation. Data captured included demographics, PAH aetiology, baseline functional status and concomitant PAH-specific medications. Safety signals captured included death, hospitalisation, serious adverse events, unexpected adverse events and elevated aminotransferases. Within 30 months, 4,994 patients were included, representing 79% of patients receiving bosentan in Europe. In total, 4,623 patients were naïve to treatment; of these, 352 had elevated aminotransferases, corresponding to a crude incidence of 7.6% and an annual rate of 10.1%. Bosentan was discontinued due to elevated aminotransferases in 150 (3.2%) bosentan-naïve patients. Safety results were consistent across subgroups and aetiologies. The novel post-marketing surveillance captured targeted safety data ("potential safety signals") from the majority of patients and confirmed that the incidence and severity of elevated aminotransferase levels in clinical practice was similar to that reported in clinical trials. These data complement those from randomised controlled clinical trials and provide important additional information on the safety profile of bosentan.

An intervention to increase patients' trust in their physicians. Stanford Trust Study Physician Group.

PURPOSE: To investigate the effect of a one-day workshop in which physicians were taught trust-building behaviors on their patients' levels of trust and on outcomes of care. METHOD: In 1994, the study recruited 20 community-based family physicians and enrolled 412 consecutive adult patients from those physicians' practices. Ten of the physicians (the intervention group) were randomly assigned to receive a one-day training course in building and maintaining patients' trust. Outcomes were patients' trust in their physicians, patients' and physicians' satisfaction with the office visit, continuity in the patient-physician relationship, patients' adherence to their treatment plans, and the numbers of diagnostic tests and referrals. RESULTS: Physicians and patients in the intervention and control groups were similar in demographic and other data. There was no significant difference in any outcome. Although their overall ratings were not statistically significantly different, the patients of physicians in the intervention group reported more positive physician behaviors than did the patients of physicians in the control group. CONCLUSIONS: The trust-building workshop had no measurable effect on patients' trust or on outcomes hypothesized to be related to trust.

Maintaining communication in a time of uncertainty.

Today, the move to managed care and ever-ballooning technology have created new challenges for communication between physician and patient. Good communication involves a set of acquired skills that medical schools and continuing medical education programs are finally beginning to teach. One model for mastering these skills is known as the four Es: engage, empathize, educate, and enlist. The four-E model, created by the Bayer (formerly Miles) Institute for Health Care Communication in West Haven, Conn, includes techniques that can help improve a physician's ability to communicate with patients.

The determinants of successful self-catheterization programs in children with myelomeningoceles.

Myelomeningocele is a birth defect that results in lifelong consequences for the child and family. One of the abnormalities that results from the defect is a neurogenic bladder. Most children with myelomeningoceles will require a clean intermittent catheterization (CIC) program for continence. Yet, many children do not have success with these programs. The purpose of this report is to identify in the literature components of a successful self-catheterization program. The importance of proper urinary management in children with myelomeningoceles will be discussed. Physiological, developmental, and motivational qualities that are present in successful self-catheterization programs will be identified. The importance of knowing when the child is ready to learn, how to know when the child is ready to learn, and different styles of teaching self-catheterization will be discussed. Finally, nursing implications for children on CIC programs will be described.