Specific statistical considerations relevantto the design and analysis of gingivitis trials demonstrating

Simulation studies were conducted to address specific statistical issues which arise in the design and analysis of gingivitis studies whose principal aim is the demonstration of superiority or equivalence of one product to another. The effects of measurement scale, using differences or ratios of group means, particular statistical test produces and specific rules demonstrating superiority or equivalence were investigated. An alternative concept to equivalence—denoted “least as good”—was also defined and evaluated. For a wide class of possible distributions of gingivitis scores, characterized by specific gamma distributions, the student-t test applied to means of subject GI gingivitis scores proved to be the most powerful of the test produces considered, having statistical properties quite similar to the randomization or permutation test procedure. Transformations of subject GI mean gingivitis scores did not produce an advantage in demonstrating either superiority or equivalence, and in some cases made it more difficult. Little difference was observed in test results when using the difference in group means as compared with using the ratio of group means for demonstrating either equivalence or superiority. The clinically significant rule produced the lowest false-positive rates for products slightly better than the active control, and similar false-positive and -negative rates as the statistically significant rule for products clearly superior to the active control. Demonstration of product equivalence will require more subjects per group than demonstrating product superiority, the size of this difference being a function of the definition of superiority that is accepted. Showing that the 90% confidence interval for 100*R is completely contained within the [90%, 110%] interval is the preferred method of demonstrating equivalence today, although much more research needs to be done to improve methods for demonstrating product equivalence. The “least as good” alternative to “equivalence” makes it easier to demonstrate “equivalence” for products slightly better than the active control product, but both experience great difficulty in demonstrating equivalence for lest products not quite as good as the active control.     

Direct carotid sinus approach to treatment of bilateral carotid-cavernous fistulas. Case report

The authors present a patient with a complex vascular malformation composed of bilateral spontaneous carotid-cavernous fistulas (CCF's). The abnormality was supplied on the right side by the right external carotid artery (ECA) and the right internal carotid artery (ICA), and on the left side only by the left ICA. There was also an arteriovenous communication between the right ECA and the lateral sinus. Surgical embolization of both cavernous sinuses with oxidized cellulose was achieved on one side by direct puncture and on the other through one of its venous affluents, successfully occluding both CCF's and preserving the patency of both ICA's without any neurological deficit. The arteriovenous communication between the right ECA and the lateral sinus was occluded by embolization of the occipital artery and ligation of the right ECA.     

Myocardial perfusion imaging: clinical experience and recent progress in radionuclide scintigraphy and magnetic resonance imaging

In the past 20 years, radionuclide scintigraphy has proven to be a sensitive clinical tool in the assessment of myocardial perfusion abnormalities. Magnetic resonance imaging may also be used to study myocardial perfusion, but its potential value still has to emerge in the clinical setting. This review addresses the potential and achievements of both methods in clinical cardiology.     

The value of ventilation scintigraphy after single lung transplantation.

BACKGROUND: A decrease in forced expiratory volume in 1 second (FEV(1)) as a diagnostic criterion for bronchiolitis obliterans syndrome (BOS) after single lung transplantation may be influenced significantly by the presence of the native lung. To quantify and to discriminate between the relative contribution of graft and native lung to the FEV(1), we retrospectively investigated the diagnostic value of combined FEV(1) measurements and ventilation scintigraphy in pulmonary dysfunction after single lung transplantation in 11 recipients with pulmonary vascular disease, 3 with obstructive lung disease, and 3 with restrictive lung disease. METHODS: We assessed function of the native lung and the graft, and subsequently calculated an adjusted grading of BOS by correcting routine FEV(1) measurements using linear interpolation of bi-annual lung ventilation scans. RESULTS: The contribution of the native lung to the total FEV(1) was slight (median, 9%) in recipients with obstructive disease compared with recipients with vascular (38%) or restrictive lung diseases (27%). Adjusted BOS grading was not useful in patients with obstructive disease. In the other patient groups, the onset of adjusted BOS Grade 1 and standard BOS Grade 1 was at a median of 220 days (range, 127-1146 days) and 836 days (184-3065 days), respectively. CONCLUSION: Ventilation scintigraphy is a useful adjunct in the (early) diagnosis of BOS in recipients of single lung transplants who have vascular and restrictive lung diseases.     

Older adults’ preferences for exercising alone versus in groups: Considering contextual congruence

Background: A growing body of research suggests that older exercisers prefer to exercise alone rather than in group-based settings. One limitation of these studies, however, has been that researchers have failed to take into account the age-related characteristics of groups when asking adults about their preferences for exercise settings.Purpose: The overall purpose of this study was to examine the exercise preferences of 947 adults for involvement in standard exercise classes populated by participants from various categories across the age spectrum.Results: The results revealed that when faced with the prospect of exercising with considerably older or younger exercisers, participants found such an exercise context to be largely unappealing. However, in accordance with the basic tenets of self-categorization theory, the results revealed that older and younger adults alike express a positive preference for exercising in standard exercise classes comprised of similarly aged participants.Conclusions: The findings of this study challenge a growing call for exercise interventions for older adults to be primarily directed at the individual-level, and suggest that group-related intervention strategies may indeed be attractive to older exercisers.     

New digital method for quantitative assessment of nasal morphology.

Our aim was to develop and validate a new method to assess objectively and quantitatively the morphology of the nostrils after nasal or nasolabial surgery. We used digital analysis using specific mathematical algorithms to assess several geometric measurements, particularly of facial asymmetry, expressed in adimensional units. Forty-five patients with no facial anomalies (control group) were used initially to evaluate the method and to obtain variables for statistical reference. Thirty-five patients operated on for unilateral cleft lip and palate (cleft group) were then analysed and compared with the control group. Individual scores were obtained for each patient, computed, and correlated with those established by a lay panel. Statistical analysis showed good sensitivity and reliability (R>0.8).     

US and UK versions of the EQ-5D preference weights: Does choice of preference weights make a difference?

Background Most US studies that estimate EQ-5D index score generally apply the UK preference weights. We compared the validity of a newly-developed US weights to the UK weights for use of EQ-5D as a measure of health-related quality of life. Methods Data were collected from a randomized clinical trial for patients with HIV (n = 1,126) in the US. Convergent validity was examined by comparing Pearson correlations of EQ-5D index scores with the MOS-HIV Health Survey scale scores and Physical and Mental Health Summary (PHS, MHS) scores using the US and UK weights. Known-groups validity of EQ-5D US versus UK index scores was compared using clinical variables (CD4+ cell count and HIV viral load), and the MOS-HIV PHS and MHS. Score changes in the EQ-5D index from baseline to week 50 were examined using effect size (ES) estimates. Results The mean EQ-5D index scores was slightly higher using US weights than UK weights (0.87 vs. 0.84, respectively). The correlation coefficient for EQ-5D utilities using the US and UK weights was 0.98. The correlations of EQ-5D index scores with the MOS-HIV scores were moderate and similar using the US and UK weights. The EQ-5D index scores discriminated equally well for both versions between levels of CD4+ count, HIV viral load, and PHS and MHS scores (P < 0.05), suggesting equivalent known-groups validity. The changes in EQ-5D index scores from baseline to week 50 were similar for both versions (ES: 0.21 vs. 0.22 for US and UK, respectively), suggesting equivalent responsiveness to score changes. Conclusions EQ-5D index scores generated using UK and US preference weights showed equivalent psychometric properties. For assessing treatment benefit in a single population, the use of either the UK or US weights as a measure of HRQOL will not change inferences. However, for comparisons across US and UK populations, the choice between these two weights should be based on their relevance to the study population.     

Effects of 4-deoxypyridoxine on the isovolumic perfused rat heart: influence of oxygenation and glucose availability

The study was performed with isolated perfused isovolumic rat hearts. After a 40 min stabilization period, the effect of 4-deoxypyridoxine (DOP) 10(-5) M was studied with 3 Glc concentrations: 0, 3.3 and 11 mM. DOP was perfused during a 20 min normoxic or anoxic period followed by 40 min of normal perfusion. During normoxia with 11 mM Glc, DOP decreased the contracture observed in the control group. With 0 mM Glc, DOP improved developed pressure and dP/dt+ without a decrease in glycogen stores. During anoxia followed by reoxygenation, a partial protection towards CK release was observed with DOP (3.3 mM Glc). Intracellular PLP levels were higher in the 11 mM Glc group than in the other groups with and without DOP, and DOP with 11 mM Glc increased PLP levels (DOP N2 vs. DOP O2). Glycogen stores increased with 11 mM Glc without DOP (O2 vs. N2), whereas they decreased with DOP without Glc (DOP N2 vs. N2). DOP could improve the yield in glycogenolysis in normoxia and might activate mitochondrial anaerobic metabolism during anoxia.