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Results for “randomized crossover trial”

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PubMedDate not supplied

Evidence for the optimal management of acute and chronic phantom pain: a systematic review.

OBJECTIVES: The objective was to examine the evidence to determine the optimal management of phantom limb pain in the preoperative and postoperative phase of amputations. METHODS: Trials were identified by a systematic search of MEDLINE, review articles, and references of relevant trials from the period 1966-1999, including only English-language articles. Included trials involved a control group, any intervention, and reported phantom pain as an outcome. RESULTS: Twelve trials were identified, including 375 patients whose follow-ups ranged in duration from 1 week to 2 years. Only three randomized, controlled studies with parallel groups and three randomized crossover trials were identified. Eight trials examined treatment of acute phantom pain, including epidural treatments (three trials), regional nerve blocks (three trials), treatment with calcitonin (one trial), and transcutaneous electrical nerve stimulation (one trial). Three trials demonstrated a positive impact of the intervention on phantom limb pain, but the remainder demonstrated no difference between the intervention and control groups. Four trials examined late postoperative interventions, including transcutaneous electrical nerve stimulation (two trials) and the use of Farabloc (a metal threaded sock) and ketamine (one trial each). With regard to late postoperative interventions, three of the four trials showed modest short-term reduction of phantom limb pain. There was no relation between the quality of the trial and a positive result of the intervention. CONCLUSIONS: Although up to 70% of patients have phantom limb pain after amputation, there is little evidence from randomized trials to guide clinicians with treatment. Evidence on preemptive epidurals, early regional nerve blocks, and mechanical vibratory stimulation provides inconsistent support for these treatments. There is currently a gap between research and practice in the area of phantom limb pain.

Acute Disease↗

PubMed1999

Health aspects of partially defatted flaxseed, including effects on serum lipids, oxidative measures, and ex vivo androgen and progestin activity: a controlled crossover trial.

BACKGROUND: Currently there is considerable interest in the potential health benefits of oil seeds, such as soy and flaxseed, especially in relation to cardiovascular disease and cancer. OBJECTIVE: We therefore evaluated health aspects of partially defatted flaxseed in relation to serum lipids, indicators of oxidative stress, and ex vivo sex hormone activities. DESIGN: Twenty-nine hyperlipidemic subjects (22 men and 7 postmenopausal women) completed two 3-wk treatment periods in a randomized, crossover trial. Subjects were given muffins that contributed approximately 20 g fiber/d from either flaxseed (approximately 50 g partially defatted flaxseed/d) or wheat bran (control) while they consumed self-selected National Cholesterol Education Program Step II diets. Both muffins had similar macronutrient profiles. Treatment phases were separated by > or = 2 wk. RESULTS: Partially defatted flaxseed reduced total cholesterol (4.6+/-1.2%; P = 0.001), LDL cholesterol (7.6+/-1.8%; P < 0.001), apolipoprotein B (5.4+/-1.4%; P = 0.001), and apolipoprotein A-I (5.8+/-1.9%; P = 0.005), but had no effect on serum lipoprotein ratios at week 3 compared with the control. There were no significant effects on serum HDL cholesterol, serum protein carbonyl content, or ex vivo androgen or progestin activity after either treatment. Unexpectedly, serum protein thiol groups were significantly lower (10.8+/-3.6%; P = 0.007) at week 3 after the flaxseed treatment than after the control, suggesting increased oxidation. CONCLUSIONS: These data indicate that partially defatted flaxseed is effective in lowering LDL cholesterol. No effects on lipoprotein ratios, ex vivo serum androgen or progestin activity, or protein carbonyl content were observed. The significance of increased oxidation of protein thiol groups with flaxseed consumption requires further investigation.

Adult↗

PubMed1990

Testing nicotine gum for ulcerative colitis patients. Experience with single-patient trials.

Epidemiologic studies have documented an association between nonsmoking and ulcerative colitis and case reports have demonstrated that symptoms improve with smoking and worsen with removal of a nicotine source. A double-blind randomized crossover trial for individual ulcerative colitis patients (single-patient trial, or N of 1 clinical trial) was designed to study the safety, patient acceptance, and the effectiveness of nicotine gum in improving patient symptoms and proctoscopic appearance of involved colon. Seven nonsmoking patients chewed up to 10 squares/day (20 mg) of nicotine gum or placebo gum for two weeks. Therapy was crossed-over every two weeks over the eight-week trial. Effectiveness was judged from comparisons between nicotine-gum and placebo-gum periods of patient self-reported symptoms at the conclusion of each two-week period using visual analog scales and proctoscopic appearance using ordered categorical scales. Three of seven patients, all three of whom were former smokers, demonstrated sufficient improvement without adverse effects to warrant institution of nicotine gum into their drug treatment regimens. Three patients demonstrated an uncertain response, despite tolerating the drug, and have not had nicotine gum added to their regimens. One patient could not tolerate the medication and was withdrawn from the study. No serious side effects were noted. We conclude that a randomized trial for an individual patient is a useful method for evaluating treatment regimens for ulcerative colitis and that nicotine gum may be effective therapy for individual patients with ulcerative colitis who demonstrate an objective response with few adverse effects.

Adult↗

PubMed2005

The "BURP" maneuver worsens the glottic view when applied in combination with cricoid pressure.

PURPOSE: The purpose of this study was to determine if the application of a BURP maneuver to the cricoid cartilage would combine the benefits of both the BURP and the Sellick maneuvers, resulting in an improved glottic view and offer the potential of protection against passive gastric regurgitation. METHODS: This was a double-blind, prospective, randomized, crossover trial. Forty-three patients scheduled for elective surgery participated in this study. General anesthesia was induced using fentanyl, propofol and rocuronium. In a random sequence for each case and blinded to the laryngoscopist, one of three maneuvers was carried out. Direct vertical pressure, using 30 newtons, a BURP maneuver with cricoid pressure, or no pressure was applied to the cricoid and the laryngoscopic view was ascertained. A separate laryngoscopy was conducted for each maneuver and the views were graded as good (part of the glottis seen), poor (only the arytenoids were seen) or no view (only the epiglottis was seen). Endotracheal intubation was then performed in each case. RESULTS: The results showed that the combination of the BURP maneuver and cricoid pressure worsened the view obtained at laryngoscopy in 30% of cases (P = 0.007). Cricoid pressure alone worsened the view in 12.5% of cases (P = 0.279). No difference was seen in 65% of cases. All patients but one were intubated easily. CONCLUSION: There is no benefit to routinely applying a modified "BURP" maneuver to the cricoid cartilage during rapid sequence induction of anesthesia.

Adult↗

PubMed2004

Intravenous insulin decreases protein breakdown in infants on extracorporeal membrane oxygenation.

BACKGROUND/PURPOSE: Infants requiring extracorporeal membrane oxygenation (ECMO) have the highest rates of protein catabolism ever reported. Recent investigations have found that such extreme protein breakdown is refractory to conventional nutritional management. In this pilot study, the authors sought to use the anabolic hormone insulin to reduce the profound protein degradation in this cohort. METHODS: Four parenterally fed infants on ECMO were enrolled in a prospective, randomized, crossover trial. Subjects were administered an insulin infusion using a 4-hour hyperinsulinemic euglycemic clamp followed by a control saline infusion on consecutive days in random order. Whole-body protein flux and breakdown were quantified using a primed continuous infusion of the stable isotope L-[1-13C]leucine. Statistical analyses were performed using paired t tests. RESULTS: Serum insulin levels were increased 15-fold during the insulin clamp compared with the saline control (407 +/- 103 v 26 +/- 12 microU/mL; P <.05). During the insulin infusion, infants had decreased rates of total leucine flux (214 +/- 25 v 298 +/- 38 micromol/kg/h; P <.05) and leucine flux derived from protein breakdown (156 +/- 40 v 227 +/- 54 micromol/kg/h; P <.05) when compared with saline control. Overall, insulin administration produced a 32% reduction in protein breakdown (P <.05). CONCLUSIONS: In this pilot study, the anabolic hormone insulin markedly reduced protein breakdown in critically ill infants on ECMO. Because elevated protein breakdown correlates with mortality and morbidity, the administration of intravenous insulin may ultimately have broad applicability to the metabolic management of critically ill infants.

Blood Glucose↗

PubMed1993

The treatment of inclusion body myositis: a retrospective review and a randomized, prospective trial of immunosuppressive therapy.

We have sought to examine the response to immunosuppressive therapeutic intervention in inclusion body myositis (IBM) in a retrospective review of prior responses to therapy and in an open, randomized crossover trial. We collected information on the response to prior therapy on 25 patients, and for prospective therapy on 11 of these patients. All met criteria for a definite idiopathic inflammatory myopathy and had biopsy-proven IBM. Clinical and laboratory results were assessed by interviews of patients and by chart review in the retrospective trial. Manual muscle strength was assessed by a single trained observer; the patients' activities of daily living were assessed by questionnaire; and serum tests of muscle-associated enzymes were measured in the prospective trial. In the retrospective review, prednisone appeared to have been of some, albeit modest, clinical benefit in 10 of 25 (40%) patients. Other therapies, primarily azathioprine and methotrexate, also appeared to have halted the progression of weakness in 8 of 35 trials (23%). In the prospective study, combination therapy of oral azathioprine and methotrexate and a biweekly infusion of high-dose intravenous methotrexate with leucovorin rescue were given for 3 to 6 months in an open, crossover design. Both the oral and the intravenous regimens were clinically effective in some patients. There was clinical improvement in 3 trials, stabilization in 11 trials, and worsening in 5 trials, out of a total of 19 completed (22 intended) trials. The presence of active inflammation at entry into the prospective therapeutic protocol, either directly observed on muscle biopsy or indirectly indicated by serum creatine kinase level, may have been associated with clinical improvement. A complete laboratory response with normalization of creatine kinase and other muscle-associated enzymes did not, however, significantly predict clinical responsiveness in the prospective trial. In this first report, to our knowledge, of a prospective trial of immunosuppressive therapy for this disease, stabilization and even slight improvement of strength and functional abilities appeared to be achieved in some patients. We believe that prednisone and other immunosuppressive therapies were of modest benefit in about half of patients with inclusion body myositis, especially those with some evidence of active inflammation. Stabilization of an otherwise inexorably deteriorating course appears, therefore, to be an attainable goal in some patients with IBM.

Adult↗

PubMedDate not supplied

Effects of chromium and yeast supplements on carbohydrate and lipid metabolism in diabetic men.

Diabetes mellitus has been shown to develop as a consequence of chromium (Cr) deficiency in experimental animals and in humans sustained by prolonged total parenteral nutrition. Prior limited trials in humans had indicated that Cr supplements, in either inorganic or organic form, may improve carbohydrate utilization. We report here a clinical double-blind, random crossover trial of inorganic Cr trichloride, a brewer's yeast that contained Cr as glucose tolerance factor (GTF), a brewer's yeast extract without GTF, and a placebo. Forty-three outpatient diabetic men received three of these supplements for 4 mo each. Subgroups included 21 ketosis-prone men; 7 ketosis-resistant, nonobese men; and 15 ketosis-resistant obese men. Chromium levels were followed pre- and posttreatment in hair, red blood cells, plasma, and urine. Response of carbohydrate metabolism to treatment was assessed in terms of change in insulin requirements, fasting plasma glucose, plasma cholesterol, and triglycerides, as well as change in plasma glucose, glucagon, and insulin or C-peptide levels in response to a standard meal. In some men, these parameters were also measured after i.v. tolbutamide. Both the inorganic and organic oral Cr supplements increased measurable body pools of Cr in hair and red blood cells by about 25%. However, fasting plasma glucose and lipids and the glucose response to either the standard meal or to tolbutamide were not significantly altered by any of the treatments. Despite this lack of effect on carbohydrate levels, the ketosis-resistant subgroups demonstrated a significant increase in postprandial insulin after treatment with the brewer's yeast that contained GTF.

Blood Glucose↗

PubMed1988

Randomized surgical adjuvant trial of interferon alfa-n1 in recurrent papillomatosis.

Sixty-six patients with recurrent respiratory papillomatosis of juvenile onset were treated for six months with interferon alfa-n1 (Wellferon) in a randomized crossover trial. Half received interferon alfa-n1 intramuscularly at a dosage of 5 megaunits per square meter daily for 28 days and then thrice weekly for five months, followed by six months of observation. The other half were observed for six months and then treated. Operations were performed every two months to assess disease extent by a scale developed for this purpose. The score for the patients during the first observation period was stable. There was a statistically significant lowering of score in patients receiving interferon alfa-n1 during both periods of drug administration. Eight of 57 patients with assessable airway disease achieved complete remission, as did one additional patient with disease limited to the nasopharynx. No patients achieved complete remission during six months of observation alone. This difference was statistically significant. Patients without tracheostomy were significantly more likely to achieve remission than those with a tracheostomy. The patients who were observed after discontinuation of the drug therapy showed a significant rise in score within four months. Symptoms of toxicity included transient fever, fatigue, nausea, and headache. Elevations in serum aspartate aminotransferase levels occurred in 64% of the patients. There was an inverse correlation between age and the ability to tolerate the medication. The dose studied may be close to the maximum tolerated dose. It appears that interferon alfa-n1 as an adjuvant to routine surgical management is effective in slowing the growth of respiratory papillomas.

Clinical Trials as Topic↗

PubMedDate not supplied

Glutamine does not prevent paclitaxel-associated myalgias and arthralgias.

Myalgias and arthralgias are prominent toxicities associated with paclitaxel. Pursuant to pilot information suggesting that glutamine could markedly alleviate this toxicity, we developed a placebo-controlled, double-blind, randomized crossover trial to test this hypothesis. This trial studied 36 patients who had experienced myalgias/arthralgias related to a prior paclitaxel-containing regimen and who were then randomized to receive oral glutamine (10 grams three times a day, starting on the day of chemotherapy) x 5 days or an identical-appearing placebo. For the subsequent cycle of chemotherapy, patients were crossed over, again in a double-blind manner, to receive the alternative treatment. Patients recorded daily myalgia/arthralgia scores on numerical scales. Physicians recorded patient-reported myalgias/arthralgias using National Cancer Institute common toxicity criteria at baseline and after each course of therapy. The results of this study revealed that glutamine had no effect on the development or severity of paclitaxel-induced myalgias/arthralgias, as recorded either by the patients' daily logs or by physician-reported information. Glutamine was well tolerated, with no suggestion of more toxicity compared to placebo. Upon completion of the two cycles, patients were asked to indicate which of the two blinded courses they preferred. Of those patients indicating a preference, 29% preferred the glutamine cycle, compared with 33% who preferred the placebo cycle (P = 0.96). Thus this trial did not suggest any role for oral glutamine, compared with placebo, for preventing the development, or alleviating the severity, of paclitaxel-induced myalgias/arthralgias.

Administration, Oral↗

PubMed2000

Effects of cervical spine immobilization technique and laryngoscope blade selection on an unstable cervical spine in a cadaver model of intubation.

STUDY OBJECTIVE: Orotracheal intubation (OTI) is commonly used to establish a definitive airway in major trauma victims, with several different cervical spine immobilization techniques and laryngoscope blade types used. This experimental, randomized, crossover trial evaluated the effects of manual in-line stabilization and cervical collar immobilization and 3 different laryngoscope blades on cervical spine movement during OTI in a cadaver model of cervical spine injury. METHODS: A complete C5-C6 transection was performed by using an osteotome on 14 fresh-frozen cadavers. OTI was performed in a randomized crossover fashion by using both immobilization techniques and each of 3 laryngoscope blades: the Miller straight blade, the Macintosh curved blade, and the Corazelli-London-McCoy hinged blade. Intubations were recorded in real time on fluoroscopy and then transferred to video and color still images. Outcome measures included movement across C5-C6 with regard to angulation expressed in degrees of rotation and axial distraction and anteroposterior displacement with values expressed as a proportion of C5 body width. Cormack-Lehane visualization grades were also recorded as a secondary outcome measure. Data were analyzed by using multivariate analysis of variance to test for differences between immobilization techniques and between laryngoscope blades and to detect for interactions. Significance was assumed for P values of less than.05. RESULTS: Manual in-line stabilization resulted in significantly less movement than cervical collar immobilization during OTI with regard to anteroposterior displacement. Use of the Miller straight blade resulted in significantly less movement than each of the other 2 blades with regard to axial distraction. The Cormack-Lehane grade was significantly better with manual in-line stabilization versus cervical collar immobilization; no differences were observed between blades. CONCLUSION: Manual in-line stabilization results in less cervical subluxation and allows better vocal cord visualization during OTI in a cadaver model of cervical spine injury. The Miller laryngoscope blade allowed less axial distraction than the Macintosh or Corzelli-London-McCoy blades. The clinical significance of this degree of movement is unclear.

Cadaver↗

PubMed1992

Identifiability and exchangeability for direct and indirect effects.

We consider the problem of separating the direct effects of an exposure from effects relayed through an intermediate variable (indirect effects). We show that adjustment for the intermediate variable, which is the most common method of estimating direct effects, can be biased. We also show that even in a randomized crossover trial of exposure, direct and indirect effects cannot be separated without special assumptions; in other words, direct and indirect effects are not separately identifiable when only exposure is randomized. If the exposure and intermediate never interact to cause disease and if intermediate effects can be controlled, that is, blocked by a suitable intervention, then a trial randomizing both exposure and the intervention can separate direct from indirect effects. Nonetheless, the estimation must be carried out using the G-computation algorithm. Conventional adjustment methods remain biased. When exposure and the intermediate interact to cause disease, direct and indirect effects will not be separable even in a trial in which both the exposure and the intervention blocking intermediate effects are randomly assigned. Nonetheless, in such a trial, one can still estimate the fraction of exposure-induced disease that could be prevented by control of the intermediate. Even in the absence of an intervention blocking the intermediate effect, the fraction of exposure-induced disease that could be prevented by control of the intermediate can be estimated with the G-computation algorithm if data are obtained on additional confounding variables.

Algorithms↗

PubMed2002

Comparison of deferral rates using a computerized versus written blood donor questionnaire: a randomized, cross-over study [ISRCTN84429599].

BACKGROUND: Self-administered computer-assisted blood donor screening strategies may elicit more accurate responses and improve the screening process. METHODS: Randomized crossover trial comparing responses to questions on a computerized hand-held tool (HealthQuiz, or HQ), to responses on the standard written instrument (Donor Health Assessment Questionnaire, or DHAQ). Randomly selected donors at 133 blood donation clinics in the area of Hamilton, Canada participated from 1995 to 1996. Donors were randomized to complete either the HQ or the DHAQ first, followed by the other instrument. In addition to responses of 'yes' and 'no' on both questionnaires, the HQ provided a response option of 'not sure'. The primary outcome was the number of additional donors deferred by the HQ. RESULTS: A total of 1239 donors participated. Seventy-one potential donors were deferred as a result of responses to the questionnaires; 56.3% (40/71) were deferred by the DHAQ, and an additional 43.7% (31/71) were deferred due to risks identified by the HQ but not by the DHAQ. Fourteen donors self-deferred; 11 indicated on the HQ that they should not donate blood on that day but did not use the confidential self-exclusion option on the DHAQ, and three used the self-exclusion option on the DHAQ but did not indicate that they should not donate blood on the HQ. The HQ identified a blood contact or risk factor for HIV/AIDS or sexually transmitted infection that was not identified by the DHAQ in 0.1% to 2.7% of donors. CONCLUSION: A self-administered computerized questionnaire may increase risk reporting by blood donors.

Anonymous Testing↗

PubMed1994

A prospective randomized crossover comparison of zygote intrafallopian transfer and in vitro fertilization-embryo transfer in unexplained infertility.

60 couples aged under 38 with unexplained infertility were recruited in this prospective randomized crossover study to compare the efficacy of treatment between ZIFT and IVF-ET. A total of 150 stimulation cycles were commenced and 132 proceeded to successful egg collection (88%). Fertilization successfully occurred in 114 cycles (86.36%). A total of 110 embryo replacements were carried out, (52 uterine transfer and 58 tubal transfer). This prospective randomized cross over trial demonstrated the trend for higher implantation rate, pregnancy rate, and ongoing pregnancy rate with ZIFT over IVF-ET for patients with unexplained infertility. The actual implantation rate, pregnancy rate, and ongoing pregnancy rate with ZIFT were 13.7, 34.5, 31.0 per cent respectively compared to the results from IVF-ET which were 12.1, 26.9, 25.0 per cent respectively. However, the difference was not statistically significant. Although this study showed a 5 per cent ectopic pregnancy rate with ZIFT and none with IVF-ET, the difference was not statistically significant. Similarly, there was no difference in the overall miscarriage rate and multiple pregnancy rate between the two protocols. In conclusion, this prospective randomized crossover trial demonstrated the trend for higher reproductive outcomes in term of implantation rate, pregnancy rate, and ongoing pregnancy rate with ZIFT over IVF-ET in unexplained infertility but the difference was not statistically significant.

Adult↗

PubMed1984

Comparative efficacy of nicardipine, a new calcium antagonist, versus nifedipine in stable effort angina.

The relative efficacy of nicardipine and nifedipine was examined in a double-blind placebo-controlled randomized crossover trial. We studied 12 patients with chronic effort angina involving reproducible angina and greater than or equal to 1.5 mm of ST-segment depression on exercise treadmill test performed before and after a 1-week control period of single-blind placebo administration. Subsequently, indistinguishably prepared nicardipine 20 mg, nifedipine 10 mg, or placebo, four times a day, was administered in a randomized double-blind crossover fashion for 3 weeks (total study period 9 weeks). Exercise treadmill test was performed at the end of each 3-week period. Both nicardipine and nifedipine significantly reduced the frequency of anginal attacks and nitroglycerin consumption. Compared with placebo both drugs caused a comparable increase of the duration of exercise, of the time to angina and to the appearance of 1.5 mm ST-segment depression (P less than 0.05 placebo versus nicardipine; P less than 0.01 placebo versus nifedipine respectively). No significant side effects were observed with either drug. We conclude that nicardipine and nifedipine produce similar hemodynamic and clinical effects in patients with stable effort angina.

Aged↗

PubMed1998

Prospective, randomized trial of Doppler-assisted subclavian vein catheterization.

OBJECTIVE: To examine the rate of success and complications of Doppler-guided subclavian vein catheter insertion compared with standard insertion in patients considered at high risk for failure. DESIGN: Prospective, randomized, crossover trial. SETTING: University-affiliated tertiary care medical center. PATIENTS: Two hundred forty patients were enrolled in the study. Patients were stratified for 3 known risk factors: (1) prior surgery in the subclavian vein region, (2) prior radiotherapy at the attempted catheterization site, and (3) an abnormal weight-height ratio. INTERVENTIONS: Subclavian vein catheterization was performed either in standard or Doppler-guided fashion using the Smart Needle (Peripheral Systems Group, Mountain View, Calif), which is a Doppler probe at the tip of a cannulating needle. If subclavian vein catheterization was unsuccessful after 2 attempts, patients were crossed over to the other technique. MAIN OUTCOME MEASURE: Successful cannulation of the subclavian vein. RESULTS: The success rate, either as an initial technique or as a salvage technique, and complication rate were not significantly different with use of the Smart Needle. A subgroup of physicians had a significantly lower success rate using the Smart Needle. CONCLUSIONS: Doppler guidance did not increase the success rate or decrease the complication rate of subclavian vein catheterization when compared with the standard technique in high-risk patients. Doppler guidance was not more useful than the standard technique as a salvage technique following a previous failure of catheterization. Furthermore, real-time Doppler guidance of subclavian vein catheterization is a technique that is highly operator dependent.

Adolescent↗

PubMed1998

A randomized crossover study of disposable thermometers for prevention of Clostridium difficile and other nosocomial infections.

OBJECTIVE: To test the hypothesis that use of disposable thermometers would result in lower rates of nosocomial Clostridium difficile diarrhea and of total nosocomial infections, compared with electronic thermometers. DESIGN: Prospective randomized crossover trial. SETTING: A 700-bed university hospital providing primary and tertiary care. PATIENTS: All patients admitted to a group of 20 inpatient nursing units. INTERVENTIONS: 20 nursing units were randomized into two groups. One group randomly was assigned exclusive use of single-use disposable thermometers for patient temperature measurement, and the other group was assigned exclusive use of electronic thermometers. After 6 months, the assignments were reversed. MAIN OUTCOME MEASURES: Rates of C difficile infections, total nosocomial diarrheal episodes, and total nosocomial infections were prospectively followed in each study unit over 11 months. RESULTS: 26,350 patients were admitted to the study units and hospitalized for 120,529 patient days. There were 947 nosocomial infections (7.86 per 1,000 patient days). Nosocomial C difficile-associated diarrhea defined by positivity to both toxin B (titer > or = 1:10) and toxin A was detected in 32 patients (3.4% of all nosocomial infections). A significantly lower rate of nosocomial C difficile-associated diarrhea was observed with disposable thermometer use (0.16 per 1,000 patient days) compared with electronic thermometer use (0.37 per 1,000 patient days, relative risk [RR] = 0.44; 95% confidence interval [CI95], 0.21-0.93, P = .026). There was no difference in overall rates of nosocomial infection between the disposable and electronic groups (8.03 and 7.68 infections per 1,000 patient days, respectively; RR, 1.04; CI95, 0.92-1.19; P = .52) or in the overall rate of nosocomial diarrhea (3.34 and 3.40 per 1,000 patient days, respectively; RR, .98; CI95, 0.81-1.19; P = .87). CONCLUSIONS: The incidence of nosocomial C difficile diarrhea was reduced significantly by using single-use, disposable thermometers as compared with electronic thermometers, but there was no effect on either the overall rate of nosocomial diarrhea or the rate of total nosocomial infections.

Clostridioides difficile↗

PubMed2005

Hyperinsulinemia provokes synchronous increases in central inflammation and beta-amyloid in normal adults.

BACKGROUND: Inflammation has been implicated as a pathogenetic factor in Alzheimer disease, possibly via effects on beta-amyloid (Abeta). Hyperinsulinemia induces inflammation and is a risk factor for Alzheimer disease. Thus, insulin abnormalities may contribute to Alzheimer disease pathophysiology through effects on the inflammatory network. OBJECTIVES: To determine the effects of induced hyperinsulinemia with euglycemia on Abeta, transthyretin, and inflammatory markers and modulators in plasma and cerebrospinal fluid (CSF). DESIGN: Randomized crossover trial. SETTING: Veterans Affairs hospital clinical research unit. PARTICIPANTS: Sixteen healthy adults ranging from 55 to 81 years of age (mean age, 68.2 years). INTERVENTIONS: On separate mornings, fasting participants received randomized infusions of saline or insulin (1.0 mU.kg(-1).min(-1)) with variable dextrose levels to maintain euglycemia, achieving plasma insulin levels typical of insulin resistance. Plasma and CSF were collected after an approximately 105-minute infusion. MAIN OUTCOME MEASURES: Plasma and CSF levels of interleukin 1alpha, interleukin 1beta, interleukin 6, tumor necrosis factor alpha, F2-isoprostane (CSF only), Abeta, norepinephrine, transthyretin, and apolipoprotein E. RESULTS: Insulin increased CSF levels of F2-isoprostane and cytokines (both P<.01), as well as plasma and CSF levels of Abeta42 (both P<.05). The changes in CSF levels of Abeta42 were predicted by increased F2-isoprostane and cytokine levels (both P<.01) and reduced transthyretin levels (P = .02). Increased inflammation was modulated by insulin-induced changes in CSF levels of norepinephrine and apolipoprotein E (both P<.05). CONCLUSION: Moderate hyperinsulinemia can elevate inflammatory markers and Abeta42 in the periphery and the brain, thereby potentially increasing the risk of Alzheimer disease.

Age Factors↗

PubMed2002

Unilateral versus bilateral sacral neuromodulation in patients with chronic voiding dysfunction.

PURPOSE: Bilateral sacral nerve neuromodulation has been proposed as a more effective treatment for chronic voiding dysfunction. However no comparison with the unilateral approach has been performed. We investigated the possible advantage of bilateral sacral neuromodulation. MATERIALS AND METHODS: In a prospective randomized crossover trial we investigated 33 patients who underwent bilateral implantation of a temporary test lead. Unilateral and bilateral test stimulation was continued for 4 to 6 days in all patients. Patients were randomly assigned to start with bilateral or unilateral stimulation. Between the stimulation episodes a 2-day washout interval was scheduled. Voiding diaries were completed at baseline and during the entire stimulation period. Sacral x-rays were taken to confirm lead positioning or possible migration after implantation and at the end of the test stimulation period. After 10 days the temporary leads were removed and voiding diaries were analyzed. RESULTS: After stimulation sacral x-ray revealed test lead migration in 8 patients, leaving 12 patients with urge incontinence and 13 with voiding difficulty and urinary retention available for review. A statistically significant improvement in voiding parameters was seen during the test stimulation period. However no statistically significant improvement was seen due to bilateral stimulation compared to unilateral stimulation. Two patients with urinary retention only started voiding to completion during bilateral stimulation. CONCLUSIONS: Bilateral is in general not superior to unilateral sacral neuromodulation. However, in some individuals bilateral stimulation may be more effective in relieving symptoms. Therefore, if unilateral percutaneous nerve evaluation fails, a bilateral test should be considered.

Adult↗