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At least 541 records · Page 30Linked to original sources
PubMed1997

Confirmatory interleukin-1 receptor antagonist trial in severe sepsis: a phase III, randomized, double-blind, placebo-controlled, multicenter trial. The Interleukin-1 Receptor Antagonist Sepsis Investigator Group.

OBJECTIVE: To determine the therapeutic efficacy and safety of recombinant human interleukin-1 receptor antagonist (rhIL-1ra) in the treatment of patients with severe sepsis. DESIGN: Prospective, randomized, double-blind, placebo-controlled, multicenter trial with a planned, midstudy, interim analysis. SETTING: Ninety-one academic medical center intensive care units in North America and Europe. PATIENTS: Patients with severe sepsis or septic shock (n = 696) received standard supportive care and antimicrobial therapy for sepsis, in addition to rhIL-1ra or placebo. INTERVENTIONS: Patients were randomized to receive either rhIL-1ra (100 mg) or placebo (vehicle) by intravenous bolus, followed by a 72-hr continuous intravenous infusion of either rhIL-1ra (2.0 mg/kg/hr) or placebo. MEASUREMENTS AND MAIN RESULTS: The study was terminated after an interim analysis found that it was unlikely that the primary efficacy end points would be met. The 28-day, all-cause mortality rate was 33.1% (116/350) in the rhIL-1ra treatment group, while the mortality rate in the placebo group was 36.4% (126/346), yielding a 9% reduction in mortality rate (p = .36). The patients were well matched at the time of study entry; 52.9% of placebo-treated patients were in shock while 50.9% of rhIL-1ra-treated patients were in shock at the time of study entry (p = .30). The mortality rate did not significantly differ between treatment groups when analyzed on the basis of site of infection, infecting microorganism, presence of bacteremia, shock, organ dysfunction, or predicted risk of mortality at the time of study entry. No excess number of adverse reactions or microbial superinfections were attributable to rhIL-1ra treatment in this study. CONCLUSIONS: A 72-hr, continuous intravenous infusion of rhIL-1ra failed to demonstrate a statistically significant reduction in mortality when compared with standard therapy in this multicenter clinical trial. If rhIL-1ra treatment has any therapeutic activity in severe sepsis, the incremental benefits are small and will be difficult to demonstrate in a patient population as defined by this clinical trial.

Adult↗
PubMed2004

Ginkgo biloba does not benefit patients with tinnitus: a randomized placebo-controlled double-blind trial and meta-analysis of randomized trials.

The objective was to ascertain if Ginkgo biloba benefits patients with tinnitus. The study design was: 1. Randomized double blind trial of Ginkgo biloba versus placebo; 2. A meta-analysis of randomized placebo controlled double blind trials. Participants included 66 adult patients with tinnitus and six (including our study) randomized placebo controlled double blind trials were meta-analysed. The main outcome measures were the Tinnitus Handicap Inventory (THI), Glasgow Health Status Inventory (GHSI) and average of hearing threshold at 0.5, 1, 2, 4 kHz. In the meta-analysis the proportion of patients gaining benefit and an overall odds ratio were determined. The results showed the mean difference in change of the THI, GHSI and hearing between Ginkgo biloba (n = 31) and placebo group (n = 29) was 2.51 (CI -10.1, 5.1, P = 0.51), 0.58 (CI-4.8, 3.6, P = 0.38) and 0.68 db (CI -4.13, 2.8, P = 0.69). Meta-analysis revealed 21.6% of Ginkgo biloba treated patients (n = 107/552) gained benefit versus 18.4% (n = 87/504) of placebo treated patients with an odds ratio of 1.24 (CI 0.89, 1.71). In conclusion, Ginkgo biloba does not benefit patients with tinnitus.

Adult↗
PubMed1989

Prevention of atherosclerotic complications: controlled trial of ketanserin. Prevention of Atherosclerotic Complications with Ketanserin Trial Group.

STUDY OBJECTIVE: To determine whether ketanserin, an antagonist at the serotonin receptor, prevents important vascular events such as death, myocardial infarction, major stroke, and amputation of a leg in patients with claudication. DESIGN: Double blind, randomised, placebo controlled trial after a single blind run in period of placebo treatment for one month. SETTING: One hundred and forty seven outpatient clinics in 14 countries. PATIENTS: Total of 3899 patients over 40 years old who had had documented intermittent claudication for at least two months and in whom the ratio of systolic blood pressure in the ankle to that in the arm was less than or equal to 0.85 in both arteries of at least one foot. INTERVENTION: After the one month placebo run in period patients were randomly allocated to take 20 mg ketanserin three times daily for the first month and 40 mg three times daily thereafter or to take the same number of placebo tablets. Five months after the onset of the trial, on the recommendation of the ethical and safety committee, four patients stopped taking ketanserin and two stopped taking placebo because they had a corrected QT interval greater than 500 ms. Four months later the committee recommended that all patients taking diuretics should stop receiving trial treatment (167 of those taking ketanserin and 144 of those taking placebo). END POINT: The first primary event after randomisation. Primary events were definite myocardial infarction, major stroke, amputation above the ankle, excision of ischaemic viscera, and death due to other vascular causes. MEASUREMENTS AND MAIN RESULTS: There were 136 study end points in the 1930 patients treated with ketanserin, who were followed up for 2063 patient years, and 132 study end points in the 1969 patients treated with placebo, who were followed up for 2129 patient years. A harmful interaction of ketanserin and potassium losing diuretics resulted in an increase in the number of deaths. After patients taking potassium losing diuretics or antiarrhythmic agents were excluded [corrected] a secondary analysis showed that there were 65 end points in 1514 patients taking ketanserin and 87 in 1557 patients taking placebo, a reduction of 23% in the number of study end points in those taking ketanserin. CONCLUSIONS: Ketanserin can prolong the corrected QT interval, and the combined use of ketanserin and potassium losing diuretics can be harmful. A secondary analysis suggested a protective effect of ketanserin against cardiovascular complications in patients with claudication.

Adult↗
PubMed1988

The pragmatic approach to stroke trial design: stroke register, pilot trial, assessment of neurological then functional outcome.

Assessment of the results of medical intervention in acute stroke presents particular difficulties. Firstly the condition is extremely variable both in its clinical presentation and in its underlying pathology. Secondly, extreme care must be taken over the methods used to assess outcome. A reduction in mortality is no indication of success if there is a consequent increase in the number of survivors with extreme disability. Nor is it valid to compare functional or neurological outcome in survivors, since differences in mortality between treatment groups may upset the balancing effect of initial randomisation. Furthermore, overall 'neurological scores' are of dubious validity when the progress of patients with different patterns of disability has to be compared. Despite these difficulties a pragmatic approach can be used in which the design and conduct of a stroke trial closely resemble the normal clinical situation. This requires a knowledge of the range and natural history of stroke cases seen, best obtained from a stroke register. A pilot trial is then needed to assess the extent of variation in outcome and thus to estimate the numbers needed for the main study. The latter should then be conducted in two stages. Initially 'neurological benefit' should be assessed by counting the number of individual neurological signs which show improvement or deterioration in patients in each treatment group. Finally, a simple functional end-point should be compared in large numbers of patients with death being treated as equivalent to the worst possible non-fatal outcome. These principles are now being applied in a large, double-blind, placebo-controlled trial of low-dose beta-blockers in conscious stroke victims.

Aged↗
PubMed2004

The Desmoteplase in Acute Ischemic Stroke Trial (DIAS): a phase II MRI-based 9-hour window acute stroke thrombolysis trial with intravenous desmoteplase.

BACKGROUND AND PURPOSE: Most acute ischemic stroke patients arrive after the 3-hour time window for recombinant tissue plasminogen activator (rtPA) administration. The Desmoteplase In Acute Ischemic Stroke trial (DIAS) was a dose-finding randomized trial designed to evaluate the safety and efficacy of intravenous desmoteplase, a highly fibrin-specific and nonneurotoxic thrombolytic agent, administered within 3 to 9 hours of ischemic stroke onset in patients with perfusion/diffusion mismatch on MRI. METHODS: DIAS was a placebo-controlled, double-blind, randomized, dose-finding phase II trial. Patients with National Institute of Health Stroke Scale (NIHSS) scores of 4 to 20 and MRI evidence of perfusion/diffusion mismatch were eligible. Of 104 patients, the first 47 (referred to as Part 1) were randomized to fixed doses of desmoteplase (25 mg, 37.5 mg, or 50 mg) or placebo. Because of an excessive rate of symptomatic intracranial hemorrhage (sICH), lower weight-adjusted doses escalating through 62.5 microg/kg, 90 microg/kg, and 125 microg/kg were subsequently investigated in 57 patients (referred to as Part 2). The safety endpoint was the rate of sICH. Efficacy endpoints were the rate of reperfusion on MRI after 4 to 8 hours and clinical outcome as assessed by NIHSS, modified Rankin scale, and Barthel Index at 90 days. RESULTS: Part 1 was terminated prematurely because of high rates of sICH with desmoteplase (26.7%). In Part 2, the sICH rate was 2.2%. No sICH occurred with placebo in either part. Reperfusion rates up to 71.4% (P=0.0012) were observed with desmoteplase (125 microg/kg) compared with 19.2% with placebo. Favorable 90-day clinical outcome was found in 22.2% of placebo-treated patients and between 13.3% (62.5 microg/kg; P=0.757) and 60.0% (125 microg/kg; P=0.0090) of desmoteplase-treated patients. Early reperfusion correlated favorably with clinical outcome (P=0.0028). Favorable outcome occurred in 52.5% of patients experiencing reperfusion versus 24.6% of patients without reperfusion. CONCLUSIONS: Intravenous desmoteplase administered 3 to 9 hours after acute ischemic stroke in patients selected with perfusion/diffusion mismatch is associated with a higher rate of reperfusion and better clinical outcome compared with placebo. The sICH rate with desmoteplase was low, using doses up to 125 microg/kg.

Acute Disease↗
PubMed2003

Randomized, controlled trial of an easy-to-read informed consent statement for clinical trial participation: a study of the Eastern Cooperative Oncology Group.

PURPOSE: Studies have documented that the majority of consent documents for medical diagnosis and treatment are written at a reading level above that of the majority of the U.S. population. This study hypothesized that use of an easy-to-read consent statement, when compared with a standard consent statement, will result in higher patient comprehension of the clinical treatment protocol, lower patient anxiety, higher patient satisfaction, and higher patient accrual. METHODS: A randomized controlled trial was conducted in 44 institutions that were members or affiliates of three cooperative oncology groups. Institutions were randomly assigned to administer either an easy-to-read consent statement or the standard consent statement to patients being recruited to participate in selected cancer treatment trials. Telephone interviews were conducted with a total of 207 patients to assess study outcomes. RESULTS: Patients in the intervention arm demonstrated significantly lower consent anxiety and higher satisfaction compared with patients in the control arm. Patient comprehension and state anxiety were not affected by the intervention. Accrual rates into the parent studies also did not differ significantly between the two study groups. CONCLUSION: Clinical trial informed consent statements can be modified to be easier to read without omitting critical information. Patient anxiety and satisfaction can be affected by the consent document. The generalizability of these study results is limited by the characteristics of the patient sample. Ninety percent of the sample were white women, and the mean Rapid Estimate of Adult Literacy in Medicine score was approximately 64, indicating a literacy level at or above the ninth grade.

Clinical Protocols↗
PubMed2006

Phase III Trial of an emulsion containing trolamine for the prevention of radiation dermatitis in patients with advanced squamous cell carcinoma of the head and neck: results of Radiation Therapy Oncology Group Trial 99-13.

PURPOSE: This multicentered phase III trial was designed to compare an emulsion containing trolamine against the usual supportive care within each participating institution for patients with head and neck cancer undergoing radiation therapy. PATIENTS AND METHODS: Patients with biopsy-proven squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx were randomly assigned to one of the following treatments: prophylactic trolamine emulsion, interventional trolamine emulsion, or declared institutional preference. The primary outcome was the reduction in grade 2 or higher skin toxicity, as per National Cancer Institute Common Toxicity Criteria version 2.0. Secondary outcomes included patient-reported quality of life (QOL). RESULTS: From October 2000 to April 2002, 547 patients from 51 institutions were entered onto the trial. The average age was 59 years. Patients were predominately male (79%) and most continued to use tobacco products (52%). The rates of grade 2 or higher radiation dermatitis were 79%, 77%, and 79% in the prophylactic, interventional, and institutional preference arms of the study, respectively. No significant differences in QOL were found. CONCLUSION: The results of this trial demonstrate no advantage for the use of trolamine in reducing the incidence of grade 2 or higher radiation dermatitis or improving patient-reported QOL. The use of 15 different local standards of care highlights the need to continue research that will result in evidence-based recommendations to reduce the burden of radiation dermatitis.

Carcinoma, Squamous Cell↗
PubMed2004

Study design for a prospective randomized trial of extracranial-intracranial bypass surgery for adults with moyamoya disease and hemorrhagic onset--the Japan Adult Moyamoya Trial Group.

This article summarizes the study design and organization of a multicenter, prospective randomized trial of extracranial-intracranial (EC-IC) bypass for treating adult patients with moyamoya disease who suffered episodes of intracranial bleeding. The Japan Adult Moyamoya Trial will determine whether the combination of EC-IC bypass with risk factor modifications affects the prognosis and the incidence of recurrent bleeding attacks. Direct bypass such as superficial temporal artery-middle cerebral artery anastomosis is essential and indirect bypass procedures alone such as encephalo-duro-arterio-synangiosis or encephalo-myo-synangiosis are not dealt with in this trial. Power calculations are based on an assumption of alpha=0.05 with an annual event rate of 8% significant morbidity and mortality per year in the non-surgical group and 4% in the surgical group. The study has an 80% rate of accuracy for detection of a 20% difference between the two groups in events in a 5-year follow up.

Adult↗
PubMed1990

The safety and efficacy of zidovudine (AZT) in the treatment of subjects with mildly symptomatic human immunodeficiency virus type 1 (HIV) infection. A double-blind, placebo-controlled trial. The AIDS Clinical Trials Group.

OBJECTIVE: To evaluate the efficacy and safety of zidovudine early in the treatment of human immunodeficiency virus type 1 (HIV) infection. DESIGN: A double-blind, randomized, placebo-controlled trial with subject stratification by pretreatment CD4 T lymphocyte counts. SETTING: Multicenter trial at AIDS Clinical Trial units. SUBJECTS: Seven hundred eleven subjects with mildly symptomatic HIV infection. INTERVENTION: Three hundred fifty-one subjects were assigned to placebo and 360 to zidovudine, 200 mg orally every 4 hours. The median duration of follow-up was 11 months. MEASUREMENTS AND MAIN RESULTS: Fifty-one subjects developed the acquired immunodeficiency syndrome (AIDS), advanced AIDS-related complex, or death as a first critical event. For the stratum of subjects with more than 200 but less than 500 CD4 T lymphocytes/mm3 before treatment, 34 events occurred in placebo recipients and 12 in zidovudine recipients (P = 0.0002; relative risk [RR] estimate, 3.23 [95% CI, 1.67 to 6.24]). For the stratum of subjects with 500 to 799 CD4 T lymphocytes/mm3 before treatment, 2 events occurred in placebo recipients and 3 in zidovudine recipients. Candidiasis at study entry independently increased the risk for having an event (P = 0.005; RR estimate, 2.3 [95% CI, 1.29 to 4.12]); HIV antigenemia at study entry also increased this risk (P = 0.01; RR estimate, 2.1 [95% CI, 1.2 to 3.8]). Significant differences between the treatment groups in CD4 T-lymphocyte counts occurred in subjects with more than 200 but less than 500 CD4 T lymphocytes/mm3 after 4 weeks of therapy (P = 0.002). Differences persisted through week 52. Less prominent changes occurred in subjects with 500 or more CD4 T lymphocytes/mm3. Serum levels of HIV antigen decreased significantly in zidovudine recipients. Serious anemia and neutropenia occurred in 5% and 4% of zidovudine recipients, respectively, and in 0% and 1% of placebo recipients, respectively. CONCLUSION: Zidovudine delayed progression of HIV disease and produced little toxicity in subjects with mildly symptomatic HIV disease and less than 500 CD4 T lymphocytes/mm3.

AIDS-Related Complex↗
PubMed1985

Controlled trial of tamoxifen as single adjuvant agent in management of early breast cancer. Analysis at six years by Nolvadex Adjuvant Trial Organisation.

A randomised controlled trial of tamoxifen as a single adjuvant agent after mastectomy for early breast cancer, reported on at an average follow-up of almost 2 years in 1983, has now been followed up to a maximum of 6 years. 1285 patients aged 75 or less were entered into the trial. Premenopausal women with positive axillary nodes and postmenopausal women with both positive and negative axillary nodes were randomised to receive either tamoxifen 10 mg twice daily for two years or to the untreated control group with systemic therapy reserved until the time of relapse. 46% of the trial population had primary tumour specimens assayed for oestradiol receptor (ER) content. There has been a highly significant prolongation of the disease-free interval in the tamoxifen-treated group followed by a highly significant reduction in death rate, with 45 (34%) fewer deaths observed in the treated group than in the control group. This benefit appeared to be independent of menopausal, nodal, or ER status.

Adult↗
PubMed1980

Double-blind trial comparing two dosage schedules of beclomethasone dipropionate aerosol with a placebo in the treatment of perennial rhinitis for twelve months. Brompton Hospital/medical research council collaborative trial.

A double-blind trial comparing two dosage schedules of beclomethasone dipropinate, 200 micrograms 400 micrograms, with a placebo in the treatment of perennial rhinitis for 12 months has been undertaken in 108 patients. Both schedules of beclomethasone dipropionate were therapeutically effective but the improvement in both the nasal and conjunctival symptoms was more marked with the higher dosage. Clinical candidiasis was not observed on inspection of the nose in any of the patients before or during the trial and in only one patient was clinical candidiasis observed on inspection of the throat. Epistaxes occurred in twelve of forty patients allocated to beclomethasone dipropionate and four of twenty-three allocated to placebo who had not had them before the trial. Most of the episodes were minor but four patients, all on beclomethasone dipropionate, reduced the aerosol dosage because of epistaxes.

Administration, Intranasal↗
PubMed1982

Multiple risk factor intervention trial. Risk factor changes and mortality results. Multiple Risk Factor Intervention Trial Research Group.

The Multiple Risk Factor Intervention Trial was a randomized primary prevention trial to test the effect of a multifactor intervention program on mortality from coronary heart disease (CHD) in 12,866 high-risk men aged 35 to 57 years. Men were randomly assigned either to a special intervention (SI) program consisting of stepped-care treatment for hypertension, counseling for cigarette smoking, and dietary advice for lowering blood cholesterol levels, or to their usual sources of health care in the community (UC). Over an average follow-up period of seven years, risk factor levels declined in both groups, but to a greater degree for the SI men. Mortality from CHD was 17.9 deaths per 1,000 in the SI group and 19.3 per 1,000 in the UC group, a statistically nonsignificant difference of 7.1% (90% confidence interval, -15% to 25). Total mortality rates were 41.2 per 1,000 (SI) and 40.4 per 1,000 (UC). Three possible explanations for these findings are considered: (1) the overall intervention program, under these circumstances, does not affect CHD mortality; (2) the intervention used does affect CHD mortality, but the benefit was not observed in this trial of seven years' average duration, with lower-than-expected mortality and with considerable risk factor change in the UC group; and (3) measures to reduce cigarette smoking and to lower blood cholesterol levels may have reduced CHD mortality within subgroups of the SI cohort, with a possibly unfavorable response to antihypertensive drug therapy in certain but not all hypertensive subjects. This last possibility was considered most likely, needs further investigation, and lends support to some preventive measures while requiring reassessment of others.

Adult↗
PubMed1995

Inter-Company Collaboration Combination Trials. Clinical Trial Subcommittee of the Inter-Company Collaboration for AIDS Drug Development.

The Inter-Company Collaboration for AIDS Drug Development (ICC) represents a collaborative effort among member companies to facilitate the conduct of clinical trials on AIDS drugs. One of the goals of the ICC is to expedite the development of combination antiretroviral therapy through data and compound sharing. Recently, the ICC formed a consensus master protocol to evaluate rapidly the safety and efficacy of triple-drug combinations of antiretroviral therapy for treatment of HIV-infected patients. This concept builds upon historical work with combination chemotherapy that resulted in treatments to successfully control chronic immunosuppressive, infectious or malignant diseases, such as tuberculosis, leprosy, childhood acute lymphoblastic leukemia, and Hodgkin's lymphoma. Because of limitations on potency and the continuing emergence of drug resistance seen with use of currently available antiretroviral agents in monotherapy and two-drug combination regimens, triple-combination regimens should represent a more promising approach to maximize antiviral activity, maintain long-term efficacy, and reduce the incidence of drug resistance. The ICC master protocol is a randomized, controlled, double-blind study with a treatment duration of 52 weeks. Patients eligible to enroll in this study must have documented HIV infection, with CD4 counts between 200 and 500 cells/mm3, and no history of antiretroviral therapy. The first four triple-drug combinations will be evaluated in two trials. These regimens have been selected based on encouraging data from laboratory and clinical studies. Each ICC trial will consist of three arms, with 75 patients per arm. Protocol ICC 001 will include AZT + zalcitabine (ddC) + saquinavir, AZT + ddC + nevirapine, and AZT + ddC as the control arm.(ABSTRACT TRUNCATED AT 250 WORDS)

Antiviral Agents↗
PubMed1985

Basal forebrain lesions produce a dissociation of trial-dependent and trial-independent memory performance.

The behavioral effects of lesions in the basal forebrain (BF) of rats were evaluated using two tasks. The BF lesions included both the nucleus basalis magnocellularis (NBM) and the medial septal area (MSA). The first task was a Stone maze, which has 14 consecutive choice points and is a task of complex, trial-independent memory. BF lesions did not impair choice accuracy in this task. The second task was a win-shift spatial discrimination in a radial arm maze, which requires trial-dependent memory. BF lesions produced a significant decrease in choice accuracy in this task. These results demonstrate that BF lesions impair trial-dependent (working) memory but not trial-independent reference memory, and that task difficulty is not the sole factor determining whether BF lesions produce behavioral impairments.

Animals↗
PubMed1991

Organizing multicenter trials: lessons from cardiovascular prevention trials.

Careful and thorough planning are essential aspects of a clinical trial that can make the difference and lead to a more successful trial. The value of feasibility studies should be recognized. The use of surrogate endpoints has justifiably come under increased scrutiny. The many complex issues of implementation demand experienced trial investigators. An openness to learn from lessons in previous trials is essential.

Cardiovascular Diseases↗
PubMed1998

Evaluation of bioequivalence of highly variable drugs using clinical trial simulations. II: Comparison of single and multiple-dose trials using AUC and Cmax.

PURPOSE: Evaluating of the effects of high intrasubject variability in clearance (CL) and volume of distribution (V), on 90% confidence intervals (CIs) for AUC (Area Under the concentration Curve) in single and multiple-dose bioequivalence studies. The main methodology was Monte Carlo simulation, and we also used deterministic simulation, and examination of clinical trials. The results are compared with those previously observed for Cmax (maximum concentration.) METHODS: The time course of drug concentration in plasma was simulated using a one-compartment model with log-normal statistical distributions of intersubject and intrasubject variabilities in the pharmacokinetic parameters. Both immediate-release and prolonged-release products were simulated using several levels of intrasubject variability in single-dose and multiple-dose studies. Simulations of 2000 clinical bioequivalence trials per condition (138 conditions) with 30 subjects in each crossover trial were carried out. Simulated data were compared with data from actual bioequivalence trials. RESULTS: The current simulations for AUC show similar probabilities of failure for single-dose and multiple-dose bioequivalence studies, even with differences in the rate of absorption or fraction absorbed. AUC values from prolonged-release scenario studies are more sensitive to changes in the first order absorption rate constant ka, and to variability in CL and V than AUC from studies of immediate-release studies. CONCLUSIONS: We showed that multiple-dose designs for highly variable drugs do not always reduce intrasubject variability in either AUC or Cmax, although the behavior of AUC differs from Cmax. Single dose AUC to the last quantifiable concentration was more reliable than either single dose AUC extrapolated to infinity, or multiple dose AUC during a steady-state interval. Multiple-dose designs may not be the best solution for assessing bioequivalence of highly variable drugs.

Area Under Curve↗
PubMed1997

Using British trial procedures in American cases: a more civil trial?

A number of attorneys, judges, and legal scholars have asserted that the overly combative nature of American trials may impact on the actual quality of justice and bring the legal system into disrepute. In contrast, many who witness criminal and civil trials conducted in Great Britain are struck by the greater apparent civility of the courtroom atmosphere. Closer examination of the English system reveals seven specific procedural differences that may contribute to this perceived change in atmosphere. In this study, these procedural differences were manipulated and their effect on verdict and on perceptions of trial participants measured. In addition, opinions about these differences were elicited. Results showed that while the trial was perceived as more civil, and the judge viewed more positively, participants tended to indicate preferences for the American style. Implications of these results are discussed.

Adult↗
PubMed2003

Flawed trial of micturition in cervical spinal cord injury patients: guidelines for trial of voiding in men with tetraplegia.

STUDY DESIGN: A retrospective study. OBJECTIVES: (1) To raise awareness of flawed trial of micturition (TOM) in male spinal cord injury (SCI) patients; and (2) to present guidelines for trial of voiding in male SCI patients. SETTING: Regional Spinal Injuries Centre, Southport, UK. METHODS: Trial of micturition in male SCI patients refers to discarding indwelling catheters and establishing them on balanced voiding with penile sheath drainage. We describe seven SCI patients, whose trial of micturition was flawed. RESULTS: Two patients (C-6 and C-4 tetraplegia respectively) developed severe autonomic dysreflexia (headache, sweating, and increase in blood pressure) 2-3 h after removal of urethral catheter. A C-4 tetraplegic developed severe urinary infection after TOM. Four patients with tetraplegia started retaining increasing amounts of urine and developed urinary infections/autonomic dysreflexia/hydronephrosis 1-21 months after they were established on sheath drainage after TOM. CONCLUSION: During TOM, patients with cervical SCI could develop autonomic dysreflexia, urinary infection, or hold progressively increasing volumes of residual urine. TOM should be guided by videourodynamics. SCI patients need alpha-blockers, and anticholinergics if voiding pressures are >40-50 cm H(2)O. If high urethral resistances are found, sphincterotomy and/or bladder neck incision will help the patients to void by triggering. SCI patients, who had undergone successful TOM, require meticulous follow-up including urodynamics. Intermittent catheterisation without adequate medications based on cystometrogram may be hazardous, and may result in upper tract damage. Facilities for supplementary catheterisation (three to four times a day) should be available in the community if a patient is unable to maintain complete, low-pressure, emptying of bladder.

Adolescent↗