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Results for “randomized crossover trial”

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PubMed2005

Randomized controlled trial of transdermal secretin on behavior of children with autism.

Previous trials of secretin for the treatment of autism have utilized a single or double dose administered intravenously. This is a report of a double-blind, randomized, controlled crossover trial of transdermally applied secretin in 15 children diagnosed with autism or pervasive developmental delay. Secretin or placebo was applied daily, in ointment form, to the backs of the children in randomized, successive 4 week periods with an intermediate 6 week washout period. Behavioral outcomes were measured by parents and teachers using the Autism Treatment Evaluation Checklist. Overall, there were no statistically significant differences in speech, sociability, sensory, and health scores for treatment versus placebo periods. In addition, there were no differences in such scores for children with a history of diarrhea. Severity of autism was significantly greater at baseline in children receiving concomitant medications. Improvement in speech was found during the treatment phase of the trial (p=0.0479 for secretin versus placebo) only in children not using other medications.

Administration, Cutaneous↗

PubMed1988

Activity of a new antiemetic agent: alizapride. A randomized double-blind crossover controlled trial.

Alizapride is a methoxy-2-benzamide derivative three times more potent than its parent compound, metoclopramide, as an antagonist of apomorphine-induced emesis in dogs. The antiemetic activity of alizapride plus dexamethasone (DXM) was compared with that of placebo plus DXM in a randomized, double-blind, crossover study in cancer patients receiving cisplatin (DDP). Alizapride, given at the maximally tolerated dose of 4 mg/kg x 5, or placebo was given in a sequence determined by randomization during two successive, identical courses of antitumor chemotherapy. The antiemetic treatment was given 30 min before and 1.5, 3.5, 5.5, and 7.5 h after starting. DXM, in a dose of 12 mg, was given IV with the first administration of alizapride or placebo. A total of 39 patients completed the two courses of chemotherapy. The severity of gastrointestinal symptoms was influenced by previous treatment but not by the treatment sequence. Although our overall results suggest that alizapride does not add to the activity of DXM against DDP-induced amesis, a statistically significant difference favoring alizapride plus DXM was found among patients with the lowest gastrointestinal tolerance to DDP: women, patients under 50 years of age, and patients pretreated with chemotherapy including DDP and non-DDP agents. Side effects consisted of orthostatic hypotension, which was symptomatic in two patients, and a single occurrence of severe extrapyramidal syndrome. We conclude that alizapride is more active than placebo when combined with DXM for DDP-induced emesis in patients at high risk of severe nausea and vomiting. The severity of the side effects in this study indicates that a dose reduction of alizapride might be appropriate for further studies.

Adolescent↗

PubMed2002

Effects of moderate alcohol intake on fasting insulin and glucose concentrations and insulin sensitivity in postmenopausal women: a randomized controlled trial.

CONTEXT: Epidemiologic data demonstrate that moderate alcohol intake is associated with improved insulin sensitivity in nondiabetic individuals. No controlled-diet studies have addressed the effects of daily moderate alcohol consumption on fasting insulin and glucose concentrations and insulin sensitivity. OBJECTIVE: To determine whether daily consumption of low to moderate amounts of alcohol influences fasting insulin and glucose concentrations and insulin sensitivity in nondiabetic postmenopausal women. DESIGN, SETTING, AND PARTICIPANTS: Randomized controlled crossover trial of 63 healthy postmenopausal women, conducted at a clinical research center in Maryland between 1998 and 1999. INTERVENTIONS: Participants were randomly assigned to consume 0, 15, or 30 g/d of alcohol for 8 weeks each as part of a controlled diet. All foods and beverages were provided during the intervention. An isocaloric beverage was provided in the 0-g/d arm. Energy intake was adjusted to maintain constant body weight. MAIN OUTCOME MEASURES: Fasting insulin, triglyceride, and glucose concentrations, measured at the end of each dietary period; insulin sensitivity, estimated with a published index of glucose disposal rate corrected for fat-free mass based on fasting insulin and fasting triglyceride concentrations, compared among treatments with a mixed-model analysis of variance. RESULTS: A complete set of plasma samples was collected and analyzed for 51 women who completed all diet treatments. Consumption of 30 g/d of alcohol compared with 0 g/d reduced fasting insulin concentration by 19.2% (P =.004) and triglyceride concentration by 10.3% (P =.001), and increased insulin sensitivity by 7.2% (P =.002). Normal-weight, overweight, and obese individuals responded similarly. Only fasting triglyceride concentration was significantly reduced when comparing 0 and 15 g/d of alcohol (7.8%; P =.03), and no difference was found between consumption of 15 and 30 g/d of alcohol; however, there was a significant linear trend (P =.001). Fasting glucose concentrations were not different across treatments. CONCLUSIONS: Consumption of 30 g/d of alcohol (2 drinks per day) has beneficial effects on insulin and triglyceride concentrations and insulin sensitivity in nondiabetic postmenopausal women.

Aged↗

PubMedDate not supplied

A randomized controlled trial of the effect of alcohol consumption on blood pressure.

Forty-six healthy normotensive male drinkers participated in a randomized, controlled, crossover trial to study the effects of varying alcohol intake on blood pressure. Alcohol consumption (calculated from weekly diaries) was reduced from 336.3 (s.e.m. = 20.2) to 64.5 (s.e.m. = 5.6) ml ethanol/week by drinking low alcohol content beer alone. Systolic blood pressure fell significantly during reduction of alcohol intake and rose again when normal drinking habits were resumed, the mean difference during the last 2 weeks of normal or low alcohol intake being 3.8 mmHg. This effect of alcohol on blood pressure was independent of a small but significant decrease in weight following reduction of alcohol intake. The change in blood pressure correlated with change in alcohol consumption (r = 0.53, P less than 0.001) with a 1 mmHg fall predicted for each 100 ml of reduction in ethanol intake/week. We conclude that regular moderate alcohol consumption has a direct (but reversible) pressor effect in normotensive men.

Adult↗

PubMed2026

Acute pre-exercise oral intake of cacao polyphenols attenuates central fatigue development during sustained low-intensity ankle dorsiflexion exercise in healthy young male adults.

This double-blind, randomized, crossover study investigated whether acute cacao polyphenol (CP) ingestion attenuates neuromuscular fatigue in 19 healthy young male adults. After consuming CP or placebo, participants performed sustained isometric ankle dorsiflexion at 25% of maximal voluntary isometric contraction (MVIC) torque until task failure. Neuromuscular function (MVIC torque, voluntary activation [VA%], doublet torque) and electromyographic activity were assessed before, immediately after, and during recovery (1 and 5 min). Salivary chromogranin A and α-amylase were measured at baseline and 1 min post-task. Only VA% and chromogranin A showed significant condition × time interactions (p = 0.027-0.039). VA% significantly decreased from before to immediately after the task and 1 min post-task in both conditions (p ≤ 0.002), with significantly higher values in the CP condition than in placebo immediately after and 1 min post-task (p ≤ 0.037). Chromogranin A significantly increased from baseline to 1 min post-task in the placebo condition (p < 0.001) but not in the CP condition (p = 0.083). These findings suggest that acute CP ingestion attenuates the decline in central motor drive and autonomic stress responses following strenuous exercise, without altering performance or peripheral recovery, supporting its potential as a nutritional strategy for modulating central fatigue.

Humans↗

PubMed2002

Preliminary findings from a prospective, randomized trial of two palatal operations for sleep-disordered breathing.

OBJECTIVES: We compared the efficacy of 2 palatal surgical procedures in the treatment of patients with mild sleep-disordered breathing (SDB). STUDY DESIGN AND SETTING: We conducted a prospective, randomized, crossover surgical trial at a university hospital. METHODS: Twenty patients with mild SDB for whom conservative treatment failed were identified and consecutively enrolled into an institutional review board-approved surgical protocol. They were randomly assigned to undergo either radiofrequency ablation of the palate (RFAP) for a planned 3-stage treatment or laser-assisted uvulopalatoplasty (LAUP), also for 3 stages of treatment, using a CO(2) laser. Parameters assessed included severity of SDB (polysomnography), subjective and objective loudness of snoring (visual analog scale and SNAP recording), sleepiness (Epworth Sleepiness Scale), and anatomic changes (upper airway endoscopy), as well as demographic factors. Patients not achieving satisfactory improvement in their condition were crossed over to the alternative surgical therapy for attempted salvage. RESULTS: Seventeen of the enrolled patients have completed the protocol. Ten of these were randomized to the RFAP group, and 7 to the LAUP group. Six of the RFAP patients (60%) achieved a satisfactory resolution of their snoring, and 4 failed and were salvaged with LAUP. Six of the LAUP patients (86%) achieved a satisfactory resolution of their snoring, and 1 patient failed and was salvaged with nasal surgery. One patient who was initially cured had a relapse after 9 months and was successfully salvaged with RFA. CONCLUSION: Prospective, randomized trials of surgery for SDB are possible. Preliminary findings from the current protocol reveal a slight advantage of LAUP over RFAP but with a greater degree of discomfort postoperatively.

Adult↗

PubMed2001

Intravenous pyridoxine-induced metabolic acidosis.

STUDY OBJECTIVE: Pyridoxine hydrochloride, the antidote for isonicotinic acid hydrazide (INH)--induced seizures, is available in solution at a concentration of 100 mg/mL at a pH of less than 3. Pyridoxine is often infused rapidly in large doses for INH-induced seizures. Effects of pyridoxine infusion on base deficit in amounts given for INH poisoning have not been studied in human subjects. We hypothesized that this infusion would result in transient worsening of acidosis. METHODS: We conducted a randomized, controlled crossover trial in human volunteers. Five healthy volunteers (mean age, 35 years; range, 29 to 43 years) were randomized to receive intravenous placebo (50 mL of normal saline solution) or 5 g of pyridoxine (50 mL) over 5 minutes. A peripheral intravenous catheter was established in each arm, and a heparinized venous blood sample was obtained for base deficit at baseline and 3, 6, 10, 20, and 30 minutes after infusion. After at least a 1-week washout period, the volunteers were assigned to the alternate arms of the experiments, thus acting as their own control subjects. Data were analyzed by using the 2-tailed paired t test, controlling for multiple comparisons. RESULTS: No difference was noted between groups at baseline. A statistically significant increased base deficit was noted after the pyridoxine infusion versus control at 3 to 20 minutes but not at 30 minutes (P =.1). Maximal mean increase in base deficit (2.74 mEq/L) was noted at 3 minutes. CONCLUSION: A transient increase in base deficit occurs after the infusion of 5 g of pyridoxine in normal volunteers.

Acidosis↗

PubMed2002

Effects of diet and simvastatin on serum lipids, insulin, and antioxidants in hypercholesterolemic men: a randomized controlled trial.

CONTEXT: Limited information exists on the interaction between diet and 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors (statins) and the interaction's effect on serum lipid and lipoprotein levels, insulin sensitivity, and circulating antioxidant vitamin and provitamin levels. OBJECTIVE: To evaluate the separate and combined effects of diet and simvastatin therapy on serum levels of lipids, lipoproteins, antioxidants, and insulin. DESIGN, SETTING, AND PARTICIPANTS: Randomized, controlled crossover trial conducted from August 1997 to June 1998 in 120 previously untreated hypercholesterolemic men aged 35 to 64 years who were recruited from the community in Turku, southwestern Finland. INTERVENTIONS: After a 4- to 6-week placebo run-in period, participants were randomly allocated to a habitual diet (n = 60) or dietary treatment group (n = 60), and each of these groups was further randomized in a double-blind crossover fashion to receive simvastatin (20 mg/d) or placebo, each for 12 weeks (n = 30 in each group). The main goals of the dietary treatment were to reduce energy intake from saturated plus trans-unsaturated fats to no more than 10% by replacing them partly with monounsaturated and polyunsaturated fats rich in omega-3 fatty acids and to increase intake of fruits, vegetables, and dietary fiber. MAIN OUTCOME MEASURES: Changes in levels of total, low-density lipoprotein (LDL), and high-density lipoprotein (HDL) cholesterol; triglycerides; apolipoprotein B; insulin; glucose; and antioxidants at week 12 of each treatment period, compared among the 4 groups. RESULTS: Dietary treatment decreased levels of total cholesterol by 7.6% (P<.001), LDL cholesterol by 10.8% (P<.001), HDL cholesterol by 4.9% (P =.01), apolipoprotein B by 5.7% (P =.003), serum insulin by 14.0% (P =.02), and alpha-tocopherol by 3.5% (P =.04). Simvastatin decreased levels of total cholesterol by 20.8%, LDL cholesterol by 29.7%, triglycerides by 13.6%, apolipoprotein B by 22.4%, alpha-tocopherol by 16.2%, beta-carotene by 19.5%, and ubiquinol-10 by 22.0% (P<.001 for all) and increased levels of HDL cholesterol by 7.0% (P<.001) and serum insulin by 13.2% (P =.005). Glucose levels remained unchanged in all groups. The effects of dietary treatment and simvastatin were independent and additive. CONCLUSIONS: A modified Mediterranean-type diet rich in omega-3 fatty acids efficiently potentiated the cholesterol-lowering effect of simvastatin, counteracted the fasting insulin-elevating effect of simvastatin, and, unlike simvastatin, did not decrease serum levels of beta-carotene and ubiquinol-10.

Adult↗

PubMed1991

Use of isosorbide dinitrate for the symptomatic treatment of patients with Chagas' disease achalasia. A double-blind, crossover trial.

1. A randomized, double-blind, placebo-controlled trial was carried out to determine the efficacy of isosorbide dinitrate (ISD) on dysphagia in patients with Chagasic achalasia. 2. Twenty-three patients with Chagas' disease and dysphagia entered the study and 20 (87%) completed the two 7-day treatment periods. Subjects were given either 5 mg ISD (12 patients) or placebo (11 patients) by the sublingual route for the first 7 days. On the 8th day, patients crossed over and began another 7-day period during which they received the opposite, identical-appearing tablets. 3. Scores attributed by uninformed investigators for the frequency and severity of dysphagia were significantly lower (P less than 0.05) following ISD treatment than after the placebo period or for the pretreatment condition. A significantly higher degree of improvement of dysphagia was experienced by the patients during ISD treatment than during the placebo period. Fourteen patients experienced meal-related headaches during ISD, but not placebo treatment. The extent of improvement in general well-being due to ISD was the same when the drug was given in the first or second test period. 4. Our results indicate that ISD, 5 mg by the sublingual route, is effective in alleviating dysphagia in patients with Chagasic achalasia but its usefulness is limited by the high rate of headache as a side effect.

Adolescent↗

PubMed2004

Oral appliance therapy reduces blood pressure in obstructive sleep apnea: a randomized, controlled trial.

STUDY OBJECTIVE: To investigate the short-term effect (4 weeks) of oral appliance therapy for obstructive sleep apnea on blood pressure. DESIGN: Randomized, controlled, crossover trial. SETTING: Multidisciplinary sleep disorders clinic in a university teaching hospital. PATIENTS: Sixty-one patients diagnosed with obstructive sleep apnea on polysomnography (apnea hypopnea index > or = 10 per hour and at least 2 of the following symptoms--daytime sleepiness, snoring, witnessed apneas, fragmented sleep; age > 20 years; and minimum mandibular protrusion of 3 mm). INTERVENTION: A mandibular advancement splint (MAS) and control oral appliance for 4 weeks each. MEASUREMENTS AND RESULTS: Polysomnography and 24-hour ambulatory blood pressure monitoring were carried out at baseline and following each 4-week intervention period. Patients showed a 50% reduction in mean apnea hypopnea index with MAS compared with the control and a significant improvement in both minimum oxygen saturation and arousal index. There was a significant reduction with the MAS in mean (+/- SEM) 24-hour diastolic blood pressure (1.8 +/- 0.5 mmHg) compared with the control (P = .001) but not in 24-hour systolic blood pressure. Awake blood-pressure variables were reduced with the MAS by an estimated mean (+/- SEM) of 3.3 +/- 1.1 mmHg for systolic blood pressure (P = .003) and 3.4 +/- 0.9 mmHg for diastolic blood pressure (P < .0001). There was no significant difference in blood pressure measured asleep. CONCLUSION: Oral appliance therapy for obstructive sleep apnea over 4 weeks results in a reduction in blood pressure, similar to that reported with continuous positive airway pressure therapy.

Adult↗

PubMed2001

The effect of two different dosages of intravenous immunoglobulin on the incidence of recurrent infections in patients with primary hypogammaglobulinemia. A randomized, double-blind, multicenter crossover trial.

BACKGROUND: In patients with hypogammaglobulinemia, substitution with immunoglobulin is the treatment of choice to reduce both frequency and severity of bacterial infections. Even with treatment, however, infections still occur in these patients. OBJECTIVE: To determine whether doubling the standard dose of intravenous immunoglobulin would affect the incidence and duration of infections. DESIGN: Multicenter, double-blind, randomized, crossover study. SETTING: 15 outpatient clinics in the Netherlands. PATIENTS: 43 patients with primary hypogammaglobulinemia, 41 of whom completed the protocol. INTERVENTION: Patients received standard-dose immunoglobulin therapy for 9 months, followed by a 3-month washout period, and high-dose intravenous immunoglobulin therapy for 9 months, or vice versa. MEASUREMENTS: The primary outcome measures were total number and duration of infections. Other measures were periods of fever, hospital admissions, use of antibiotics, absence from school or work, and trough levels of serum immunoglobulin. Side effects from the study medication were also recorded. RESULTS: Compared with the standard dose of intravenous immunoglobulin (adults, 300 mg/kg of body weight every 4 weeks; children, 400 mg/kg every 4 weeks), high-dose therapy (adults, 600 mg/kg every 4 weeks; children, 800 mg/kg every 4 weeks) significantly reduced the number (3.5 vs. 2.5 per patient; P = 0.004) and duration (median, 33 days vs. 21 days; P = 0.015) of infections. Trough levels of IgG increased significantly during high-dose therapy. The incidence and type of side effects did not differ significantly for the two dosages. CONCLUSION: In patients with hypogammaglobulinemia, doubling the standard dose of intravenous immunoglobulin significantly reduced the number and duration of infections.

Adolescent↗

PubMed2003

Preliminary findings from a prospective, randomized trial of two tongue-base surgeries for sleep-disordered breathing.

OBJECTIVES: This study compares the efficacy of 2 tongue-base surgical procedures in the treatment of patients with moderate to severe sleep-disordered breathing. STUDY DESIGN AND SETTING: We conducted a prospective, randomized crossover surgical trial at a university hospital. METHODS: Seventeen patients with moderate to severe sleep-disordered breathing and Fujita type II upper airway collapse for whom conservative treatment failed were enrolled into an institutional review board-approved surgical protocol. They were randomly assigned to undergo palatopharyngoplasty combined with either tongue advancement (mandibular osteotomy) or tongue suspension. Parameters assessed included severity of sleep-disordered breathing (polysomnography), sleepiness (Epworth Sleepiness Scale), and anatomic changes (upper airway endoscopy), as well as demographic factors. Patients not achieving satisfactory improvement in their condition were offered nonsurgical management or additional surgical treatment that varied based on the postoperative assessment but included crossing over to the other tongue surgical procedure. RESULTS: Nine of the 17 patients were randomized to the tongue suspension group, and 8 to the tongue advancement group. In the 9 tongue suspension patients, Epworth Sleepiness Scale scores fell from 12.1 to 4.1 (P = 0.007). Airway collapse for all 9 patients measured on Müller maneuver improved, by a mean of 64% (P = 0.0006) at the palate and 83% (P = 0.0003) at the base of the tongue. In the 8 tongue advancement patients, Epworth Sleepiness Scale scores fell from a mean of 13.3 to 5.4 (P = 0.004). Airway collapse for 5 of 8 patients measured on Müller maneuver improved by a mean of 31% (P = 0.1) at the palate and 75% (P = 0.03) at the base of the tongue. CONCLUSION: Prospective, randomized trials of tongue-base surgery for sleep-disordered breathing are possible. Preliminary findings from the current protocol reveal a slight advantage of tongue suspension over tongue advancement.

Adolescent↗

PubMed2005

Comparison of plain ice and flavoured ice for preventing oral mucositis associated with the use of 5 fluorouracil.

AIMS AND OBJECTIVES: The study aimed to compare the use of plain ice, flavoured ice and standard care, to evaluate the effect on mucositis and to determine patients' perceptions of the two forms of oral cryotherapy. BACKGROUND: Despite evidence that oral cryotherapy is useful in preventing mucositis in patients receiving 5-fluorouracil, concerns have been expressed about its clinical utility, due to potential side effects and negative perceptions. DESIGN: A randomized, controlled, crossover trial was conducted in the outpatient chemotherapy department of an acute care teaching hospital in Perth, Western Australia. Patients were randomized to receive each of three interventions across three cycles of chemotherapy: standard care alone; standard care plus plain ice; and standard care plus flavoured ice. METHODS: Oral mucositis was assessed by nurses prior to each of the three chemotherapy cycles and 15 days after each intervention. Two assessment tools were used, the Oral Assessment Guide, and the Western Consortium Cancer Nursing Research Scale. Participants completed a questionnaire to determine their comfort and satisfaction with oral cryotherapy, as well as factors affecting compliance. RESULTS: Findings from 67 patients revealed that when participants used standard care alone, they were significantly more likely to experience symptoms of mucositis than when they used either plain or flavoured ice. Odds ratios were at least threefold higher for standard care alone, varying according to the instrument used. The two main concerns reported were the taste of flavoured ice and the time required to complete the cryotherapy interventions. Side effects such as nausea, sensitivity and headache were reported more frequently for flavoured ice (n = 11) compared with plain ice (n = 5) and standard care (n = 1). CONCLUSIONS: Both forms of oral cryotherapy were effective in reducing the severity of oral mucositis after chemotherapy and were more effective than standard care alone. Flavoured ice was associated with the highest frequency of side effects. RELEVANCE TO CLINICAL PRACTICE: The benefits of cryotherapy appear to outweigh the problems in this sample of patients. The intervention should be tailored to individual patients, based on preferences for plain versus flavoured ice and small chips vs. larger blocks. Unsweetened frozen fruit juices should be evaluated. Time constraints could be addressed by providing transportable containers of ice.

Antimetabolites, Antineoplastic↗

PubMed1994

A placebo-controlled trial of trihexyphenidyl in unmedicated patients with schizophrenia.

Seventeen patients with schizophrenia who had been free of medication for at least 2 months entered a placebo-controlled, random-order crossover trial of 5 mg of trihexyphenidyl twice daily for 4 weeks. Ten patients completed trials of both drug and placebo. Ratings of anticholinergic symptoms and of feeling the effects of the drug, controlled for order effects, were significantly higher at week 4 of the trihexyphenidyl trial than at week 4 of the placebo trial. Measures of psychosis, negative symptoms, depression, and liking the drug did not differ between trihexyphenidyl and placebo trials.

Adult↗

PubMed2005

Comparative effects of hydroxocobalamin and cyanocobalamin on plasma homocysteine concentrations in end-stage renal disease.

End-stage renal disease (ESRD) is associated with marked hyperhomocysteinemia which is only partially corrected by folic acid and pyridoxine supplementation. We and others have reported that various forms of parenteral cobalamin reduce plasma total homocysteine (tHcy) concentrations of patients with ESRD substantially below the lowest levels attainable with folic acid. We here report a 16-week randomized controlled crossover trial which directly compared the Hcy-lowering effect of intravenous hydroxocobalamin (HC) with that of cyanocobalamin (CC). Folic acid- and vitamin B12-replete maintenance hemodialysis patients were randomly assigned to receive either 1 mg intravenous HC weekly for 8 weeks followed by CC for a further 8 weeks, or CC for 8 weeks followed by HC for 8 weeks. Hydroxocobalamin increased serum cobalamin concentrations 40-fold, whereas CC increased them only 10-fold, but both treatments reduced plasma tHcy concentrations similarly by 33% (P < .001). Crossover to the alternate form of the vitamin greatly affected the serum cobalamin concentration but was without further effect on the plasma tHcy concentration. These results confirm that weekly cobalamin injections lower plasma tHcy concentrations of hemodialysis patients well below the level attainable with folic acid. Hydroxocobalamin and CC are equipotent despite producing very different serum cobalamin concentrations.

Cross-Over Studies↗

PubMed2001

Impact of the Edmonton Labeled Visual Information System on physician recall of metastatic cancer patient histories. a randomized controlled trial.

The Edmonton Labeled Visual Information System (ELVIS) is a novel method of documenting clinical information because it is a pictorial method of representing cancer burden and treatment. This randomized, crossover, multiperiod trial involved 16 physicians who each reviewed two ELVIS and two control (text) cancer patient cases (total 32 ELVIS and 32 text cases). Short-answer questionnaires were administered immediately and 18--24 hours following. Mean (+/- SD) recall of basic disease and treatment information was superior immediately following the ELVIS cases (83% +/- 14%) versus text cases (60% +/- 14%, P < 0.0001) and 18--24 hours later (ELVIS cases 65% +/- 21% versus text cases 43% +/- 21%, P < 0.0001). Mean (+/- SD) time required to memorize information was reduced in the ELVIS cases (4 +/- 2 min) versus text cases (13 +/- 6 min, P < 0.0001). Ratings of overall physician preference strongly favored the ELVIS over text. The data indicate that ELVIS aids the process of learning complex cancer patient histories.

Audiovisual Aids↗

PubMedDate not supplied

Functional Incidental Training: applicability and feasibility in the Veterans Affairs nursing home patient population.

OBJECTIVE: To examine the applicability and feasibility of an intervention directed at improving continence, endurance, and strength (Functional Incidental Training [FIT]), for older patients in Veterans Administration (VA) nursing homes. DESIGN: Data were collected during a randomized, controlled, crossover trial. SETTING: Four VA nursing homes. PARTICIPANTS: All 528 patients in the nursing homes were screened, 178 were eligible, and 107 were randomized into the trial. A total of 64 participants completed the intervention phase of the trial. INTERVENTION: Trained research staff provided the FIT intervention, which included prompted voiding combined with individualized, functionally oriented endurance and strength training exercises offered four times per day, 5 days per week, for 8 weeks. MEASURES: Descriptive data were collected relevant to the translation of the FIT intervention into everyday practice, including number of patients eligible and reasons for ineligibility, attrition rates and reasons for attrition, participant adherence to and satisfaction with FIT, and the costs of FIT relative to usual care. RESULTS: One third of the 528 patients met the eligibility criteria. The major reasons for ineligibility were being continent, age under 60, and a short anticipated length of stay. Of the 146 patients enrolled in the trial, 85 (58%) dropped out during the 9- to 10-month project. Deterioration in health status, death, and discharge accounted for two thirds of the attrition. Adherence to FIT was in general high but variable. Participants completed prompted voiding plus at least one exercise in 75% of the FIT rounds offered. Of the 60 participants who completed the protocol and who could answer simple questions, 75% indicated they enjoyed FIT, but 62% indicated that the exercise was too frequent, and 28% indicated they were offered opportunities to toilet too often. Based on timed observations, the costs of FIT are about four times as high as usual continence care. CONCLUSIONS: FIT is applicable to a substantial number of patients in VA nursing homes. The FIT protocol tested in this trial can be further refined and individualized based on patient preferences and adherence to various components of FIT in order to make it more feasible, efficient, and cost-effective in practice. The costs of maintaining an intervention such as FIT in all VA nursing home patients who may benefit, however, are high and must be justified largely by potential positive effects on function and quality of life, as opposed to cost savings resulting from the intervention.

Aged↗

PubMed2005

Randomized, controlled trial on the effect of a 20% mannitol solution and a 7.5% saline/6% dextran solution on increased intracranial pressure after brain injury.

OBJECTIVE: The aim of this pilot study was to compare the effects of equimolar doses of hypertonic saline and dextran solution (HSD, Rescueflow) with 20% mannitol solution for reduction of increased intracranial pressure. DESIGN: Prospective, randomized, controlled, crossover trial in the intensive care unit of a large teaching hospital. SETTING: Academic hospital and tertiary referral center for neuroscience. PATIENTS: Nine patients with an intracranial pressure of >20 mm Hg were recruited and received two treatments of each, HSD and 20% mannitol, in a randomized order. INTERVENTION: Equimolar, rapid intravenous infusions of either 200 mL of 20% mannitol or 100 mL of 7.5% saline and 6% dextran-70 solution (HSD) over 5 mins. MEASUREMENTS: Intracranial pressure, blood pressure, serum and urine sodium and osmolality, and urine output. MAIN RESULTS: Treatments reduced intracranial pressure with both mannitol (median decrease, 7.5 mm Hg, 95% confidence interval, 5.8-11.8) and HSD (median decrease, 13 mm Hg; 95% confidence interval, 11.5-17.3). HSD caused a significantly greater decrease in intracranial pressure than mannitol (p = .044). HSD had a longer duration of effect than mannitol (p = .044). CONCLUSION: When given in an equimolar, rapid, intravenous infusion, HSD reduces intracranial pressure more effectively than mannitol.

Adolescent↗