A comprehensive clinical validation of the nuclear stethoscope

Five studies were conducted to examine the degree of variability to be expected during the use of the non-imaging nuclear probe (BIOS Inc.) under a variety of clinical conditions. Comparison of the ejection fraction (EF) readings between the nuclear probe and a gamma camera showed good agreement, with the nuclear probe tending to underestimate lower, and overestimate higher camera EF values [mean (S.D.) difference, 0.84% (6.06)]. A comparison of two nuclear probes showed a small mean (S.D.) difference of EF readings of 0.063% (2.26). EF readings obtained in normal subjects 6 weeks apart were reproducible and differed by a mean (S.D.) of 0.23% (4.42). The administration of placebo to 10 normal subjects followed by sequential measurements for 4 h produced EF changes large enough to mimic a clinical effect, the largest hourly change observed being 5.4%, indicating the need for strict placebo control in interventional experiments. Data on four patients with heart failure showed small non-significant EF changes in the 1 h after placebo administration but a wide intra-subject range of ejection time and time to peak filling measurements. This highlights the problem of accurate, reproducible cursor placement in such patients. The nuclear probe is a portable, low cost instrument which produces accurate EF measurements when compared with the gamma camera.     

Blood pool ventriculography with a new technetium-labelled complex (99mTc-DEPIC) : a clinical evaluation

A new, single bolus method of in vivo blood pool imaging using a technetium Tc99m phosphine isocyanide complex (DEPIC) which binds to pre-albumin was evaluated in volunteers (n=4) and patients (n=20). DEPIC was assessed for its safety and possible drug interactions. Its duration of action and quality of ventriculography were compared with imaging using standard in vivo red cell labelling (PYP) during two 3-h scanning periods 1 week apart. DEPIC had a mean plasma halflife of 3.3 h. The count rate over the left ventricle was initially 42% higher with DEPIC than with PYP. However, removal of DEPIC by the liver resulted in equivalent count rates by 1 h, and by 3 h PYP count rates were 22% higher than DEPIC. Immediately post injection mean (SD) difference in the left ventricular ejection fraction between the two methods was 2.4% (7.7%). Satisfactory DEPIC scans were obtained up to 2 h post injection, but by 3 h there was a mean difference of 13% (11.3%). DEPIC was found to be a safe alternative to red all labelling for blood pool angiography, suitable for routine work. The single bolus methodology and high initial count rates offer improved efficiency and a capability for truly emergency scanning.     

An assessment of intrarenal hydrostatic pressure measurements in the diagnosis of acute renal allograft rejection

Postoperative intrarenal pressure measurements may be an aid to the diagnosis of acute renal transplant rejection, especially in patients treated with cyclosporine. Serial measurements of intrarenal pressure were made in 38 recipients using a fine-needle technique. Thirty-two intraoperative and 207 postoperative measurements were made, and 39 clinical rejection episodes (23 confirmed by biopsy) monitored. Intraoperative pressures in grafts with immediate function (37.4 +/- 4.0 mmHg, mean +/- SEM) were not significantly different from those with delayed function (30.9 +/- 4.8 mmHg), whereas postoperative pressures were greater (P less than 0.01) in kidneys with acute tubular necrosis (29.4 +/- 1.9 mmHg) than in functioning grafts (20.4 +/- 0.9 mmHg). Pressures recorded during clinical rejection episodes (44.3 +/- 2.3 mmHg) exceeded (P less than 0.001) those during quiescent periods (23.6 +/- 1.0 mmHg). During rejection episodes, higher pressures (P less than 0.01) were recorded from tender or palpably enlarged grafts (52.5 +/- 3.0 mmHg) than in the absence of these signs (36.3 +/- 3.1 mmHg), and patients whose transplants biopsies showed cellular rejection tended to have greater pressures (50.1 +/- 4.1 mmHg) than those with concomitant vasculopathy (36.4 +/- 3.9 mmHg), but the latter did not reach statistical significance. In 7 cases of cyclosporine toxicity the intrarenal pressure was 17.8 +/- 4.2 mmHg. Using a diagnostic cut off point of 40 mmHg, the investigation failed to recognize 26% of acute rejection episodes--and, in the presence of acute tubular necrosis, it wrongly categorized 21% of nonrejectors. While its predictive capacity was limited, the test may occasionally be helpful in the differentiation of cyclosporine toxicity and rejection in functioning kidneys.     

The ST segment of the ambulatory electrocardiogram in a normal population.

The behaviour of the ST segment in everyday life was studied by ambulatory electrocardiography in 111 normal volunteers. Fifteen were excluded because of abnormal exercise responses (10 subjects) and significant postural ST segment shifts (five subjects). This left 62 men and 34 women, mean (SD) age 40.5 (12.6) years (range 20-67 years). Ambulatory monitoring of leads CM5 and CC5 for 24 hours was followed by a maximal treadmill exercise test. The tapes of the ambulatory monitoring were analysed by a computer aided system. The computer printed trend plots of the ST segment (measured both at the J point and at J + 60 ms) to detect episodes of ST segment elevation and depression, which were confirmed by visual analysis of real time printouts. Twelve subjects showed "ischaemic" ST segment depression and nine subjects showed ST segment elevation. Eight people with ambulatory ST segment changes were studied during exercise by radionuclide ventriculography and thallium-201 imaging scans. Although seven of the eight thallium studies were normal, radionuclide ventriculography showed functional impairment in five cases. Seven of the 10 subjects with abnormal exercise tests were similarly investigated and their results followed the same pattern, with normal thallium images in six and functional impairment in four. Ambulatory electrocardiography was repeated in 20 people after a median of 20 days. The ST segment changes were reproducible. ST segment changes of an apparently ischaemic nature occur even in a carefully defined normal population but they do not necessarily represent latent clinically significant coronary artery disease. This indicates that ST segment changes seen in patients with known obstructive coronary artery disease should be interpreted with caution.     

Case mix measurement in English hospitals: an evaluation of five methods for predicting resource use

OBJECTIVES: The introduction of an internal market in the British National Health Service (NHS) has highlighted the importance of developing appropriate, valid and timely measures of hospital activity, both for the purposes of specifying and monitoring contracts and for evaluating the success of the NHS reforms in general. This paper compares the validity of five case mix methods (Diagnosis Related Groups (DRGs); Healthcare Resource Groups (HRGs) versions 1 and 2; specialty classification; a simple age categorization) in predicting resource use. METHODS: Two data sets were used to compare different case mix methods. A 3% random sample (n approximately equal to 300,000) of the 1992/3 Hospital Episodes Statistics was used to test their ability to predict variation in length of stay, and a second set of individually costed patient episodes from two hospitals (n approximately equal to 40,000) was used to test their ability to explain cost variation. Analysis of variance models were used to assess the fit of each of the case mix systems to test data and a simple significance test of differences in mean squared error between models was applied. RESULTS: All case mix methods performed poorly on untrimmed data. When lengths of stay greater than 29 days were excluded, version 2 of HRGs explained 31% of total variance in length of stay and 25% of cost variation. DRGs explained less variance but performed better than HRGs version 1. For a typical hospital patient population consisting of a range of specialties, the difference in explanatory power between HRGs V2 and DRGs was statistically significant at the 5% level for sample sizes of approximately 2000 or greater. For individual specialties, the minimum sample size required for the difference between the groupers to be significant ranged from around 300 to over 2000. CONCLUSIONS: The locally developed HRGs version 2 system appears to offer superior performance in terms of resource homogeneity to other currently available approaches. It is also more adaptable and cheaper than imported alternatives and has been formally endorsed by the UK medical Royal Colleges.     

24-hour blood pressure control with the once-daily calcium antagonist amlodipine

The efficacy and toleration of once-daily amlodipine (5-10 mg) was studied in 11 patients with mild to moderate hypertension. Continuous intra-arterial blood pressure monitoring was used to study the effects of amlodipine over a 24-h period. Following a 2-week placebo run-in period, amlodipine was given initially as a single-blind 5-mg dose for 2 weeks and increased to 10 mg if required to control blood pressure for a further 4 weeks. Twenty-four-hour intra-arterial blood pressure recordings made after 6 weeks of treatment with amlodipine revealed that amlodipine effectively reduced blood pressure throughout the whole 24-h period without altering the normal circadian pattern. The mean daytime blood pressure was reduced from 165/103 to 147/89 mm Hg (p < 0.05) and the mean nighttime blood pressure was reduced from 137/79 to 121/69 mm Hg (p < 0.05). There was no significant change in heart rate. The mean supine blood pressure measured sphygmomanometrically was reduced from 169/103 mm Hg after placebo to 153/98 mm Hg after 2 weeks of treatment and to 145/92 mm Hg at the end of the study. The results of isometric and dynamic exercise testing showed that amlodipine decreased blood pressure, with no postural decrease on tilting and no change in the proportional increase in blood pressure at peak exercise. Amlodipine was well tolerated although one patient developed ankle edema that would have required discontinuation had she not already completed the study. This study has shown that amlodipine effectively reduced blood pressure for 24 h after once-daily dosing and was well tolerated.