Patient selection and the assessment of blood pressure in clinical trials

A new method for selecting patients with mild-to-moderate hypertension who are appropriate for entry into clinical trials and a technique for assessing small but statistically significant decreases in diastolic blood pressure resulting from drug therapy are described. In this method, mild-to-moderate hypertension is defined to exclude subjects whose diastolic blood pressure decreases while they are taking placebo and to exclude subjects with highly variable diastolic blood pressure. A subject receives placebo for four weeks, during which time diastolic blood pressure while supine is measured three times on a single day of each week, the time between measurements not being less than 30 minutes. With the 12 measurements obtained during the four-week placebo period, the following calculations are made: an average of the 12 measurements; and average of the three measurements obtained on a given day, yielding the average diastolic blood pressure per week; and the range of the 12 measurements. Subjects are selected for study if their average diastolic blood pressure per week for the four-week placebo period is neither below 95 nor above 115 mmHg, if their average diastolic blood pressure per week does not decrease successively from week 1 to week 4, and if the range of the 12 measurements of diastolic blood pressure recorded over the four-week placebo period does not exceed 28 mmHg (equivalent to a standard deviation of 8.5). Use of the method is demonstrated in the selection of 63 patients for a double-blind study of two antihypertensive drugs.(ABSTRACT TRUNCATED AT 250 WORDS)     

Influence of nifedipine on cyclosporin A nephrotoxicity after unilateral nephrectomy in the spontaneously hypertensive rat.

1. Nifedipine ameliorates cyclosporin A-induced renal impairment in surgically intact (two-kidney) rats. This study investigates the effect of nifedipine on cyclosporin A nephrotoxicity in spontaneously hypertensive rats after either uninephrectomy or uninephrectomy with contralateral renal denervation. 2. Fourteen days after uninephrectomy pair-fed rats were injected for 14 days with cyclosporin A (25 mg/kg body weight) via the subcutaneous route and with nifedipine (0.1 mg/kg body weight) via the intraperitoneal route. Renal and systemic haemodynamics were measured in conscious unrestrained rats. 3. Whole-blood levels of cyclosporin A did not differ between groups (overall 352 +/- 22 ng/ml, means +/- SEM). After uninephrectomy, cyclosporin A decreased the glomerular filtration rate (olive oil versus cyclosporin A: 0.96 +/- 0.04 versus 0.70 +/- 0.06 ml min-1 100 g body weight, P less than 0.02) and effective renal plasma flow (1.94 +/- 0.10 versus 1.38 +/- 0.13, P less than 0.01), and increased renal vascular resistance [(20.2 +/- 1.8) x 10(4) versus (31.6 +/- 3.3) x 10(4) kPa l-1 s [(20.2 +/- 1.8) x 10(3) versus (31.6 +/- 3.3) x 10(3) dyn s cm-5], P less than 0.02] and mean arterial pressure (146.7 +/- 6.7 versus 167.3 +/- 2.9 mmHg, P less than 0.05). Neither renal denervation nor nifedipine prevented the reduction in glomerular filtration rate or effective renal plasma flow induced by cyclosporin A. 4. This study infers that the sympathetic nervous system does not play an active role in cyclosporin A nephrotoxicity and demonstrates that the concomitant administration of nifedipine to rats with reduced renal mass does not ameliorate cyclosporin A-induced renal impairment.     

Objective Versus Subjective Assessment of Functional Status in Candidates for Liver Transplantation

Introduction

and aim. Poor functional status is associated with increased mortality in cirrhosis patients awaiting liver transplantation (LT); however, the optimal assessment of functional status remains unknown. This study sought to determine the relationship between 6-minute walk distance (6MWD) and Karnofsky Performance Status (KPS) and their association with waitlist mortality in LT candidates.

Adult education program in palliative care for nursing facility physicians: design and pilot test

Nursing facilities (NF) are important sites for the care of dying patients. Curricula likely to improve end-of-life care are needed for NF physicians. To this end, a model medical school palliative care curriculum was modified for experienced NF physicians. Adult learning techniques were emphasized, as well as interactions likely to change physician behavior. Inclusion of the opinion leader, audit with feedback, use of consensus guidelines, and other techniques for changing physician behavior were included. Written materials to supplement the course were identified. This new program was pilot tested and improved. An initial audit of physician practices and survey of the NF staff, a half-day adult educational session, and follow-up with the NF medical director is suggested. This intervention should be tested to determine if it improves patient end-of-life care outcomes in this setting.     

Improving organizational and individual performance through coaching: A case study

Organizational change occurs when a critical mass of people within an organization begin to experience one another and the world in which they work differently—a shift of minds.     

Cognitive processing of trauma cues in rape victims with post-traumatic stress disorder

Rape victims with post-traumatic stress disorder (PTSD) (n =12), rape victims without PTSD (n =12), and nontraumatized control subjects (n =12) performed a computerized Stroop color-naming task in which they named the colors of high-threat words (e.g., RAPE), moderate-threat words (e.g., CRIME), positive words (e.g., LOYAL), and neutral words (e.g., TYPICAL). In contrast to rape victims without PTSD and to nontraumatized control subjects, those with PTSD were slower to color-name high-threat words than moderate-threat, positive, and neutral words. Rape victims without PTSD nevertheless exhibited greater Stroop interference for high-threat words than did nontraumatized subjects. Interference for high-threat words was correlated with scores on the Impact of Events Scale —Intrusion subscale, but not with scores on the Avoidance subscale. These findings suggest that interference for trauma cues may provide a nonintrospective index of intrusive cognitive activity. Preparation of this article was supported, in part, by grants from the Henry and Ramsey Pevsner Fund in Neuropsychology and Behavioral Medicine and the American Association of University Women — Aurora, Illinois, Chapter awarded to Karen Lynn Cassiday, and National Institute of Mental Health grant MH43809 awarded to Richard J. McNally.This study was part of the first author's doctoral dissertation, conducted under the supervision of the second author. It was conducted when the authors were at the Department of Psychology, University of Health Sciences/The Chicago Medical School. A shorter version of this paper was presented at the annual meeting of the Association for Advancement of Behavior Therapy, San Francisco, November, 1990.     

The management of solitary tumours of Hoffa's fat pad

Hoffa's fat pad (HFP) of the knee is affected by a variety of tumours and tumour-like conditions. HFP can be affected by diffuse or solitary, focal disease.This paper reports a consecutive series of 19 cases of solitary symptomatic HFP tumours. The commonest presenting symptom was anterior knee pain. All patients underwent open excision after diagnostic magnetic resonance imaging (MRI). Histology revealed varied diagnoses with the commonest being pigmented villonodular synovitis (PVNS) and ganglia. American Knee Society scores improved from 76 pre-operatively to 96 post-operatively with an improvement in functional scores from 92 to 100.In conclusion the majority of solitary HFP tumours are benign and may be either cystic or solid. MRI and plain radiographs are the imaging of choice. The definitive treatments of both cystic and solid tumours should be selective arthrotomy and excision biopsy. All patients in this series reported substantial improvement in symptoms following surgery.