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PubMed2006

Medicare program; rural health clinics: amendments to participation requirements and payment provisions; and establishment of a quality assessment and performance improvement program; suspension of effectiveness. Interim final rule with comment period; partial suspension of effectiveness.

This interim final rule with comment period revises the rural health clinic (RHC) regulations to revert to those provisions set forth in regulations before publication of the December 24, 2003 RHC final rule. That final rule implemented certain provisions of the Balanced Budget Act (BBA) of 1997 to establish a process and criteria for disqualifying from the RHC program clinics that no longer meet basic location requirements (rural and medically underserved), and to require RHCs to establish quality assessment and performance improvement programs. That rule also prohibited "commingling" (the use of the space, professional staff, equipment, and other resources) of an RHC with another entity. [In addition, it addressed comments on the February 28, 2000 proposed rule. Since the publication of the RHC final rule exceeded the 3-year timeline for finalizing proposed rules set by the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, we are suspending the effectiveness of the current provisions by removing the RHC provisions set forth in the December 2003 final rule and reverting to those RHC provisions previously in effect.] We intend to reissue new proposed and final RHC rules to reinstate the current provisions. However, these revisions do not impact the effectiveness of the self-implementing provisions of the BBA or any provisions we had previously implemented or enforced through program memoranda.

Ambulatory Care Facilities↗
PubMed2003

Assessment of the bioequivalence of two oxcarbazepine oral suspensions versus a film-coated tablet in healthy subjects.

Oxcarbazepine (trileptal) oral suspension has been reformulated and a study was performed to compare the bioavailability after single doses and at steady state of the current and former oral suspension versus the marketed film-coated tablets and to compare the bioavailability of the current and former oral suspension. The results support the switch from the former oral suspension to the current oral suspension and also from both oral suspensions to the film-coated tablet and vice versa. The study was an open-label, single-center, 3-way crossover trial. Each treatment period consisted of a single dose of 600 mg oxcarbazepine on Day 1, 600 mg oxcarbazepine b.i.d. repeated administration from Day 4 up to including Day 7, and a final dose of 600 mg oxcarbazepine administered on the morning of Day 8. Blood samples were taken on Day 1, Day 7 and Day 8 (pre-dose). Plasma concentrations of the main metabolite of oxcarbazepine (MHD) were determined using a validated HPLC assay. The 2 oral suspensions were compared with the film-coated tablet as reference formulation under fasted conditions. Also the current oral suspension was compared with the former oral suspension. These comparisons were made using data following single dose administration and under steady state conditions. Plasma AUC for single dose and AUC(0-12h) at steady state and plasma Cmax, log-transformed (natural base) were used for the assessment of bioequivalence. The 90% confidence interval (CI) approach was used for testing bioequivalence. Bioequivalence was accepted if CI was contained within the region (0.8, 1.25). At steady state, both the former and the current oral suspensions showed bioequivalence with the film-coated tablet with respect to AUC and Cmax. The current oral suspension was also bioequivalent when compared to the former oral suspension with respect to AUC and Cmax. After single dose, the former oral suspension was bioequivalent when compared to the film-coated tablet with respect to both AUC and Cmax. However, the current oral suspension was bioequivalent to both the film-coated tablet and the former oral suspension with respect to AUC but not to Cmax.

Adult↗
PubMed2006

Stability and viscosity of a flavored omeprazole oral suspension for pediatric use.

PURPOSE: The stability and viscosity of preparations of a commercially available, flavored, immediate-release powder for oral suspension (omeprazole-sodium bicarbonate) during refrigerator and room temperature storage were investigated. METHODS: Omeprazole-sodium bicarbonate 20-mg packets were suspended to initial omeprazole concentrations of 0.6 and 2 mg/mL, and omeprazole-sodium bicarbonate 40-mg packets were suspended to initial omeprazole concentrations of 1.2, 2, 3, and 4 mg/mL. Suspensions were stored at 4 degrees C in darkness (refrigerated) or 22-25 degrees C (room temperature) in light for one week. A third set of suspensions was stored refrigerated for one month. Omeprazole's stability was quantified after 0, 6, 12, 24, 48, and 168 hours in one-week samples and after 0, 7, 14, 21, and 28 days in one-month samples using high-pressure liquid chromatography. Viscosities of refrigerated suspensions were measured after 0, 1, and 7 days. RESULTS: Refrigerated suspensions retained >98% and >96% of their initial omeprazole concentrations after one week and one month, respectively. Stability of room temperature suspensions was concentration dependent. After one week, the 0.6- and 1.2-mg/mL suspensions retained 87.2% and 93.1% of their respective initial omeprazole concentrations, whereas the 2-, 3-, and 4-mg/mL suspensions retained >97% of their initial omeprazole concentrations. Suspension viscosities varied 10-fold over the concentrations studied, but all were within the viscosity ranges of other commercially available oral suspensions. Prolonged refrigeration did not increase the suspensions' viscosities. CONCLUSION: Omeprazole-sodium bicarbonate suspensions of 0.6-4 mg/mL omeprazole were stored at 4 degrees C in darkness for up to 28 days. The viscosities of refrigerated suspensions did not increase over 7 days. Except for the 0.6 mg/mL preparations, suspensions stored at room temperature in the light retained >90% of their initial omeprazole content after 7 days, despite turning yellow.

Administration, Oral↗
PubMed2001

Anterior or posterior sacrospinous vaginal vault suspension: long-term anatomic and functional evaluation.

OBJECTIVE: To compare vaginal anatomy and sexual function after the conventional posterior and anterior sacrospinous vault suspension. METHODS: A retrospective repeated measures cohort study included all 168 consecutive sacrospinous vault suspension procedures between July 1990 and February 1997. The posterior suspension (n = 92) used a posterior vaginal incision and pararectal dissection. Anterior suspension (n = 76) involved an anterior rather than posterior vaginal incision, retropubic perforation, and dissection of a paravaginal-paravesical rather than pararectal space to accommodate the vaginal vault. Two polytetrafluoroethylene (00) sutures anchored the anterior vaginal cuff (for the anterior sacrospinous suspension) or the posterior vaginal cuff (for the posterior sacrospinous suspension) to the ligament. Postoperative evaluation included an examination using the pelvic organ prolapse quantitative system, assessment of vaginal width and axis, and symptom questionnaire. RESULTS: Total vaginal length and apical suspension were slightly greater after the anterior suspension, and recurrent anterior vaginal relaxation was less likely. No differences were found in maximal dilator size or apical narrowing between the two groups. New onset dyspareunia was reported by two subjects in the anterior vault suspension group, and two in the posterior vault suspension group. Three of these four cases of de novo dyspareunia were attributable to either severe atrophy or recurrent prolapse, and none to vaginal narrowing or shortening. CONCLUSION: After anterior sacrospinous vault suspension, vaginal length and apical suspension were slightly increased, and recurrent anterior vaginal prolapse decreased compared with the posterior sacrospinous suspension technique. Upper vaginal caliber and sexual function appear well preserved using either technique.

Adult↗
PubMed2000

Oral pharmacokinetics of omeprazole and lansoprazole after single and repeated doses as intact capsules or as suspensions in sodium bicarbonate.

BACKGROUND: Omeprazole and lansoprazole can be given in sodium bicarbonate as, respectively, simplified omeprazole suspension and simplified lansoprazole suspension. We previously found the antisecretory effect of omeprazole 20 mg given as simplified omeprazole suspension to be lower than with intact capsules. However, lansoprazole 30 mg as simplified lansoprazole suspension produced an effect similar to that seen with intact capsules. AIM: To evaluate the absorption of both drugs when given orally as capsules or as suspensions in sodium bicarbonate. METHODS: In random order, we gave 5-day courses of omeprazole 20 mg and lansoprazole 30 mg as capsules and as suspensions in sodium bicarbonate to 12 healthy women. Serial blood samples were taken on days 1 and 5 of each course for pharmacokinetic measurements. RESULTS: There was impairment of omeprazole absorption when given as simplified omeprazole suspension. Maximum plasma concentration and area under the concentration/time curve were lower with simplified omeprazole suspension than with omeprazole capsules (P=0.034 and 0.013, respectively, on day 5). No differences were found in lansoprazole absorption when simplified lansoprazole suspension was compared with its standard capsule formulation. Relative bioavailability of omeprazole from simplified omeprazole suspension compared to the capsule was 58.4% on day 5. The corresponding value for lansoprazole was 84.7%. CONCLUSIONS: Simplified omeprazole suspension 20 mg does not supply adequate omeprazole for systemic absorption. Lansoprazole absorption from simplified lansoprazole suspension is maintained.

2-Pyridinylmethylsulfinylbenzimidazoles↗
PubMed2001

L-NAME, a nitric oxide synthase inhibitor, as a potential countermeasure to post-suspension hypotension in rats.

A large number of astronauts returning from spaceflight experience orthostatic hypotension. This hypotension may be due to overproduction of vasodilatory mediators, such as nitric oxide (NO) and prostaglandins. To evaluate the role of the NO synthase inhibitor NG-nitro-L-arginine methyl ester (L-NAME) as a countermeasure against the post-suspension reduction in mean arterial pressure (MAP), we assessed the cardiovascular responses and vascular reactivity to 7-day 30 degrees tail-suspension and a subsequent 6 hr post-suspension period in conscious rats. After a pre-suspension reading, direct MAP and heart rate (HR) were measured daily and every 2 hrs post-suspension. The NO synthase inhibitor L-NAME (20 mg/kg, i.v.), or saline, were administered after the 7th day reading prior to release from suspension and at 2 and 4 hrs post-suspension. At 6 hrs post-suspension, vascular reactivity was assessed. While MAP did not change during the suspension period, it was reduced post-suspension. Heart rate was not significantly altered. L-NAME administration reversed the post-suspension reduction in MAP. In addition, the baroreflex sensitivity for heart rate was modified by L-NAME. Thus, the post-suspension reduction in MAP may be due to overproduction of NO and altered baroreflex activity.

Animals↗
PubMed2001

Indomethacin attenuates post-suspension hypotension in Sprague-Dawley rats.

Orthostatic hypotension is a serious condition that is sometimes manifested in astronauts during standing postflight. These observations may be related to impairment of autonomic function and/or excessive production of endothelium-dependent relaxing factors. To evaluate the role of the cyclooxygenase inhibitor indomethacin as a countermeasure against the post-suspension reduction in mean arterial pressure (MAP), we examined the cardiovascular responses to 7-day 30 degrees tail-suspension and a subsequent 6-hr post-suspension period in conscious male Sprague-Dawley rats. Indomethacin (2 mg/kg) or saline were administered intravenously prior to release from suspension and at 2 and 4 hrs post-suspension. Direct MAP and heart rate were determined prior to suspension, daily and every 2 hrs post-suspension. During suspension, MAP did not change, in contrast, during post-suspension; it decreased compared to parallel non-suspended, untreated animals. There were no significant changes in heart rate. The reduction in MAP post-suspension was associated with significant increases in plasma prostacyclin. Indomethacin attenuated the observed post-suspension reduction in MAP and reduced plasma prostacyclin levels. Also, the baroreflex sensitivity for heart rate was modified by indomethacin--the MAP threshold for baroreflex activation was raised and the effective MAP range expanded. Thus, the post suspension reduction in mean arterial pressure may be due to overproduction of vasodilatory prostaglandins and/or other endothelium-dependent relaxing factors and alteration in baroreflex activity.

Animals↗
PubMed2002

Bladder neck needle suspension for urinary incontinence in women.

BACKGROUND: Bladder neck needle suspension is an operation traditionally used for moderate or severe stress urinary incontinence in women. About a third of adult women experience some urinary incontinence, and about a third of them have moderate or severe symptoms. OBJECTIVES: To determine the effects of needle suspension on stress or mixed urinary incontinence in comparison with other management options. SEARCH STRATEGY: We searched the Cochrane Incontinence Group specialised register and reference lists of relevant articles. Date of last search: December 2001. SELECTION CRITERIA: Randomised or quasi-randomised trials that included needle suspension for the treatment of urinary incontinence. DATA COLLECTION AND ANALYSIS: Trials were assessed and data extracted independently by at least two reviewers. One trial investigator was contacted for additional information. MAIN RESULTS: Eight trials were identified which included 327 women having six different types of needle suspension procedures and 407 who received comparison interventions. Needle suspensions were more likely to fail than open abdominal retropubic suspension (higher subjective failure rate after the first year (70/267, 26% failed vs 33/243, 14% failed after open abdominal retropubic suspension: RR 2.10, 95% CI 1.45 to 3.04) and there were more peri-operative complications (36/75, 48% vs 23/77, 30%; RR 1.51, 95% CI 1.06 to 2.15), but there were no significant differences for other outcome measures. This effect was confined to women with primary incontinence: too few women with recurrent incontinence were studied to draw conclusions about the effects of secondary operations. Needle suspensions may be as effective as anterior vaginal repair (46/128, 36% failed after needles vs 50/129, 39% after anterior repair; RR 0.93, 95% CI 0.68 to 1.26) but there was little information about morbidity. Data for comparison with suburethral slings were inconclusive because they came from a small and atypical population. No trials compared needle suspensions with conservative management, peri-urethral injections or sham or laparoscopic surgery. REVIEWER'S CONCLUSIONS: Bladder neck needle suspension surgery is probably not as good as open abdominal retropubic suspension for the treatment of primary genuine stress urinary incontinence in terms of lower cure rates and higher morbidity. However, the reliability of the evidence was limited by poor quality and small trials. There was not enough information to comment on secondary procedures or on comparisons with suburethral sling operations. Although cure rates were similar after needle suspension compared with after anterior vaginal repair, the data were insufficient to be reliable and inadequate to compare morbidity.

Female↗
PubMed2004

Bladder neck needle suspension for urinary incontinence in women.

BACKGROUND: Bladder neck needle suspension is an operation traditionally used for moderate or severe stress urinary incontinence in women. About a third of adult women experience some urinary incontinence, and about a third of them have moderate or severe symptoms. OBJECTIVES: To determine the effects of needle suspension on stress or mixed urinary incontinence in comparison with other management options. SEARCH STRATEGY: We searched the Cochrane Incontinence Group trials register (searched 18 September 2003). The reference lists of relevant articles were also searched. SELECTION CRITERIA: Randomised or quasi-randomised trials that included needle suspension for the treatment of urinary incontinence. DATA COLLECTION AND ANALYSIS: Trials were assessed and data extracted independently by at least two reviewers. Two trial investigators provided additional information. MAIN RESULTS: Nine trials were identified which included 347 women having six different types of needle suspension procedures and 437 who received comparison interventions. Needle suspensions were more likely to fail than open abdominal retropubic suspension (higher subjective failure rate after the first year (91/313, 29% failed versus 47/297, 16% failed after open abdominal retropubic suspension: the relative risk (RR) was 2.00 (95% confidence interval (CI) 1.47 to 2.72) although the difference in peri-operative complications was not significant (17/75, 23% versus 12/77, 16%; RR 1.44, 95% CI 0.73 to 2.83): there were no significant differences for other outcome measures. This effect was seen in both women with primary incontinence and women with recurrent incontinence after failed primary operations. Needle suspensions may be as effective as anterior vaginal repair (46/128, 36% failed after needles versus 50/129, 39% after anterior repair; RR 0.93, 95% CI 0.68 to 1.26) but there was little information about morbidity. Data for comparison with suburethral slings were inconclusive because they came from a small and atypical population. No trials compared needle suspensions with conservative management, peri-urethral injections, sham or laparoscopic surgery. REVIEWERS' CONCLUSIONS: Bladder neck needle suspension surgery is probably not as good as open abdominal retropubic suspension for the treatment of primary and secondary urodynamic stress incontinence because the cure rates were lower in the trials reviewed. However, the reliability of the evidence was limited by poor quality and small trials. There was not enough information to comment on comparisons with suburethral sling operations. Although cure rates were similar after needle suspension compared with after anterior vaginal repair, the data were insufficient to be reliable and inadequate to compare morbidity.

Female↗
PubMed2002

Experimental optimization of pivot point height for swing-arm type rear suspensions in off-road bicycles.

Towards the ultimate goal of designing dual suspension off-road bicycles which decouple the suspension motion from the pedaling action, this study focused on determining experimentally the optimum pivot point height for a swing-arm type rear suspension such that the suspension motion was minimized. Specific objectives were (1) to determine the effect of interaction between the front and rear suspensions on the optimal pivot point height, (2) to investigate the sensitivity of the optimal height to the pedaling mechanics of the rider in both the seated and standing postures, (3) to determine the dependence of the optimal height on the rider posture. Eleven experienced subjects rode a custom-built adjustable dual suspension off-road bicycle, [Needle, S., and Hull, M. L., 1997, "An Off-Road Bicycle With Adjustable Suspension Kinematics," Journal of Mechanical Design 119, pp. 370-375], on an inclined treadmill. The treadmill was set to a constant 6 percent grade at a constant velocity of 24.8 km/hr. With the bicycle in a fixed gear combination of 38 x 14, the corresponding cadence was 84 rpm. For each subject, the pivot point height was varied randomly while the motions across both the front and rear suspension elements were measured. Subjects rode in both the seated and standing postures and with the front suspension active and inactive. It was found that the power loss from the rear suspension at the optimal pivot point height was not significantly dependent on the interaction between the front and rear suspensions. In the seated posture, the optimal pivot point height was 9.8 cm on average and had a range of 8.0-12.3 cm. The average optimal pivot point height for the seated posture corresponded to an average power loss for the rear suspension that was within 10 percent of the minimum power loss for each subject for 8 of the 11 subjects. In the standing posture, the average height was 5.9 cm and ranged from 5.1-7.2 cm. The average heightfor the standing posture was within 10 percent of the minimum power loss for each subject for 9 of the 11 subjects. While the optimum height was relatively insensitive to pedaling mechanics in both the seated and standing postures, the choice of the optimal pivot point height in production bicycles necessitates some compromise in performance given the disparity in the averages between the seated and standing postures.

Adult↗
PubMed1999

Modified small-bowel follow-through: use of methylcellulose to improve bowel transradiance and prepare barium suspension.

PURPOSE: To evaluate the efficacy of barium suspension prepared in methylcellulose (MC) in modified small-bowel follow-through (SBFT). MATERIALS AND METHODS: The authors evaluated 155 patients who underwent modified SBFT with oral administration of MC after ingesting barium suspension. Of these patients, 52 received 40% suspension in MC, 46 received 40% suspension in water, and 57 received 70% suspension in water. Patients were divided into normal (n = 74) and abnormal (n = 81) groups according to the final results. The image quality, transit time to the cecum, and time to and frequency of flocculation were compared for both groups. RESULTS: In the normal group, the quality of the images in patients receiving 40% suspension in MC or 70% suspension in water was superior to that of images in patients receiving 40% suspension in water. In the abnormal group, the best image quality was achieved for the patients who received 40% suspension in MC. In the normal group, the difference in transit time between the three preparations was not substantial. In the abnormal group, however, the 40% suspension in MC showed the fastest transit time. Use of the 40% suspension in MC helped lower the frequency of flocculation in the normal group. CONCLUSION: Use of 40% barium suspension in MC is effective for improving the image quality in modified SBFT.

Barium Sulfate↗