Quality outcomes of reinterpretation of brain CT studies by subspecialty experts in stroke imaging.

OBJECTIVE: The purposes of this study were to determine the clinical importance and relative value of reinterpretation of brain CT studies by subspecialty experts by assessing the accuracy of interpretation by general radiologists at primary stroke centers and to assess interpretive quality outcomes as a function of change in the treatment of patients with stroke diagnoses or acute presentations of suspected stroke. MATERIALS AND METHODS: Computerized medical records for the years 2009-2010 at four major community hospitals were queried for primary interpretation of brain CT studies of stroke patients with an acute presentation of either stroke or suspected stroke as diagnosed by board-certified general radiologists (nonneuroradiologists). A central database was queried that allowed one to query by clinical history or symptoms. Secondary interpretation of images of the identified patient sample was then performed by three experienced neuroradiologists. Each case was initially interpreted as an emergency or urgent study by a general radiologist. The reinterpretations performed by a neuroradiologist were scored as concordant or discordant. The discordant studies were categorized as a major discordance if there was a change in clinical management or as a minor discordance if there was no effect on or change in clinical management. The assessment was limited to brain CT studies without contrast administration. CT angiography and perfusion CT studies were not included in the analysis. Patients with hemorrhagic stroke, brain tumors, abscesses, and AIDS or HIV infection were excluded to limit the assessment to ischemic nonhemorrhagic disease. RESULTS: Of the 560 studies reviewed, 14 studies (2.5%) were identified as discordant. Of those discordant studies, four (0.7% of the original 560) were categorized as major discrepancies necessitating a change in clinical management. Ten (1.78%) were categorized as minor discrepancies, for which there was no change in management. There were no permanent adverse outcomes with respect to morbidity and mortality as a result of a discrepant interpretation, as determined by chart review or communication with the attending or referring physician by the secondary reader. CONCLUSION: Most of the interpreted head CT cases read by board-certified general radiologists for patients presenting with stroke or stroke symptoms did not result in discordant interpretations as verified by subspecialty experts. Discordant interpretations did not result in changes in clinical management in most cases. Double reading of head CT scans for these patients by subspecialty experts appears to be an inefficient method of substantially improving imaging health quality outcomes in stroke.

A pilot study on the effects of S-equol compared to soy isoflavones on menopausal hot flash frequency.

BACKGROUND: S-equol, a metabolite of the soy isoflavone daidzein, has been proposed as having potential for relief of menopausal symptoms. This study compared the efficacy of the natural S-equol supplement, SE5-OH, with isoflavones for relieving hot flashes and other menopausal symptoms. METHODS: An 8-week randomized, double-blind, active comparator trial with SE5-OH was conducted in postmenopausal women (aged 45-65 years), who experienced ≥5 hot flashes/day. Participants (n=102) were assigned to one of four treatment groups: 10 (n=24), 20 (n=27), or 40 (n=25) mg S-equol/day or soy isoflavones (n=26). Participants recorded their hot flash frequency and rated their menopause symptom severity. RESULTS: Reductions in hot flash frequency at week 8 were similar for all treatment groups. However, based on analyses of the cumulative effect for the 8-week period, 40 mg/day S-equol had a greater reduction of hot flash frequency compared to isoflavones (p=0.021). A subgroup analysis further indicated that for subjects with >8 hot flashes/day at baseline, 20 and 40 mg/day S-equol were superior to isoflavones in reducing hot flash frequency (p=0.045 and p=0.001, respectively). In addition, 10 and 20 mg/day S-equol improved muscle and joint pain score compared with isoflavones (p=0.003 and p=0.005, respectively). CONCLUSIONS: S-equol, 10 mg/day, appears to be as effective as soy isoflavones at reducing hot flash frequency and more effective for relieving muscle and joint pain in postmenopausal women. S-equol, ≥20 mg/day, alleviates hot flashes to a greater extent than soy isoflavones in those women who experience >8 hot flashes/day.

The pharmacokinetics of S-(-)equol administered as SE5-OH tablets to healthy postmenopausal women.

The soy isoflavone metabolite, S-(-)equol, has selective affinity for estrogen receptor (ER)beta and also antagonizes in vivo the action of dihydrotestosterone. It is therefore of interest as a potential new therapeutic agent in hormone-dependent conditions and is under development as a nutraceutical. Our objective in this study was to define the pharmacokinetics of natural S-(-)equol after administration of SE5-OH, a newly developed S-(-)equol supplement made by incubation of the equol-producing bacterium Lactococcus garvieae with soy germ isoflavones. In a single-center, open-label, randomized, 2-period crossover design study, the pharmacokinetics of S-(-)equol administered as single-bolus oral doses of 10 and 30 mg in the form of SE5-OH tablets was determined in 12 healthy postmenopausal women. S-(-)equol was measured in plasma and urine collected at timed intervals over a 48-h period postdosing using tandem MS. Equol-producer status was also determined after a soymilk challenge conducted after the pharmacokinetic sampling was complete. S-(-)equol was rapidly absorbed after oral administration and attained high plasma concentrations, with a plasma elimination half-life of 8 h. The maximum plasma concentration/dose, area under the plasma concentration-time curve from time 0 to infinity/dose, and the fraction of dose excreted in urine (%f(e,u)) were similar for the 2 doses, indicating a dose-proportional response in total S-(-)equol pharmacokinetics. The systemic bioavailability of S-(-)equol was very high, as the %f(e,u) was 82% for both doses, which is greater than published data for the soy isoflavones daidzein and genistein. Three participants were determined to be equol-producers, representing a 25% frequency, and equol-producer status had no effect on natural S-(-)equol pharmacokinetics.