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Results for “Randomized trial”

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PubMed1977

Chemotherapy for mustard-resistant ovarian adenocarcinoma: a randomized trial for CCNU and methyl-CCNU.

In view of the need for drugs which have antitumor activity in alkylating agent-resistant ovarian cancer or which might be more potent than standard agents, a randomized trial of two nitrosoureas, CCNU and methyl-CCNU, has been conducted. Of 31 evaluable patients who received at least one dose of CCNU (100 mg/m2 orally every 6 weeks), there were only two patients who experienced even transient improvement; 18 of these patients had two or more doses over a trial period of greater than or equal to 12 weeks. Of 26 evaluable patients who received at least one dose of methyl-CCNU (150 mg/m2 orally every 6 weeks), there was one patient who experienced transient improvement; this group included 14 patients receiving at least two doses and whose trial lasted greater than or equal 12 weeks. All patients had been previously treated with mustard-type alkylating agents. None of the responses were clinically useful. Thus, women with ovarian adenocarcinoma who have a history of prior chemotherapy are not likely to benefit from treatment with these nitrosoureas.

Adenocarcinoma↗

PubMed1986

An analysis of the radiation related morbidity observed in a randomized trial of neutron therapy for bladder cancer.

This report is an analysis of the morbidity in the bladder and bowel observed in a randomized trial of d(15)+Be neutrons versus megavoltage photons in the treatment of bladder cancer. Acute reactions in the bladder and bowel were significantly worse after photon therapy. Of the patients treated with photons 45.7% had severe reactions in the bladder compared with 10.6% after neutron therapy (p less than 0.001). Severe acute bowel reactions were observed in 8.5% of the patients after photon therapy compared with 3.8% after neutron therapy (p less than 0.05). Late reactions were significantly worse after neutrons. Severe late reactions in the bladder were seen in 58.5% of patients after neutron therapy and in 40.5% after photon therapy (p less than 0.05). In the bowel they were observed in 53.3% of patients after neutron therapy compared with 8% after photon therapy (p less than 0.0001). The disparity in the degree of early and late complications makes assessment of RBE values difficult. It is estimated that for bladder morbidity the RBE value, for photon dose fractions of 2.75 Gy, is less than 3.3 for early reactions and equal to 3.4 for late effects. The respective RBE values for early and late effects in the bowel are less than 3.4 and 3.8.

Clinical Trials as Topic↗

PubMed1989

Treatment of reflux esophagitis with H2-blockers, antacids and prokinetic drugs. An analysis of randomized clinical trials.

Randomized clinical trials comparing H2-receptor antagonists, antacids, antacid/alginate and prokinetic drugs with placebo and other substances were analyzed. Symptomatic improvement has been shown for H2-receptor antagonists, antacids in very high doses and prokinetic drugs. H2-receptor antagonists, the present mainstay of reflux therapy, improve esophagitis, but they are insufficient in the treatment of severe esophagitis where omeprazole may become the therapy of choice. The evidence is weak that antacids, antacid/alginate, metoclopramide and domperidone heal esophagitis.

Antacids↗

PubMed1994

Ondansetron versus granisetron in the prevention of chemotherapy-induced nausea and vomiting. Results of a prospective randomized trial.

BACKGROUND: A single-institution, prospective, randomized open trial was performed to compare ondansetron and granisetron in the prevention of chemotherapy-related nausea and vomiting. The effect of antemetic drugs was analyzed indipendently for patients treated with highly emetogenic chemotherapy (Study 1), and those treated with moderately emetogenic regimens (Study 2). METHODS: In Study 1, 182 patients treated with chemotherapeutic regimens containing high dose cisplatin (more than 70 mg/m2) were randomized to receive 24 mg of ondasentron intravenously (i.v.) or 3 mg of granisetron i.v. for the control of acute emesis. Patients treated with fractionated chemotherapy and those followed-up for delayed emesis also received 8 mg of ondansetron orally twice a day or 3 mg of granisetron i.v. on the days after Day 1. In Study 2, 164 patients were randomized to receive either 16 mg of ondansetron i.v. or 3 mg of granisetron i.v. to prevent emesis in the first 24 hours. RESULTS: In the ondansetron group in Study 1, a complete response (CR) (i.e., no vomiting, nausea possible) from acute emesis was achieved in 52% of cases, a major response (MR) in 29%, and a minor response (MiR) in 14%. In the granisetron group in Study 1, a CR was seen in 49% of patients, an MR in 24%, and an MiR in 12%. Failure was recorded in 5% and 15% of cases in the ondansetron and granisetron groups, respectively. No statistically significant difference in any response category was seen between the two groups. In the ondansetron group, a complete protection from delayed emesis was recorded in 39% of cases, an MR in 32%, an MiR in 21%, and failure in 16%. In the granisetron arm, 36% of the patients had a CR, 22% had an MR, 14% had an MiR, and 14% experienced treatment failure. Again, these differences did not reach statistical significance. In Study 2, no statistical significant difference was observed between the ondansetron arm and the granisetron arm, both for acute and delayed emesis. Both ondansetron and granisetron were tolerated very well by most patients, with no severe side effects. In the group of patients treated with ondansetron, however, the incidence of headache (9%) was higher than in the group treated with granisetron (4%). CONCLUSIONS: These data suggest that although both ondansetron and granisetron are very effective drugs for the control of acute emesis, their efficacy against delayed emesis is still not entirely satisfactory.

Acute Disease↗

PubMed1994

A randomized trial comparing triple-drug and double-drug therapy in renal transplantation. Analysis at 7 years.

This is the 7-year update of a randomized trial comparing triple (TT) and double (DT) immunosuppressive therapy in renal transplantation. At 7 years, patient survival rate was 85% in DT vs. 87% in TT (P = NS); graft survival rate was 73% in DT and 68% in TT (P = NS); pure graft survival was 86% in DT vs. 77% in TT (P = 0.096). The 7-year graft survival rate was 67% for cadaver graft recipients vs. 92% for living-related graft recipients (P = 0.044). No difference in the slopes of plasma creatinine between the two groups was observed. Ten DT and 13 TT patients changed their original therapy: statistical analysis, however, was carried out according to intention to treat. Both CsA levels and doses were significantly higher in DT than in TT group (P < 0.001) at any time point up to the 7th year. At univariate analysis, a living-related donor kidney (P = 0.044) and immediate recovery of renal function (P < 0.001) were the only two parameters associated with graft survival at 7 years. At multivariate analysis, only early graft function recovery was correlated with late graft survival (RR = 10.480). Thus, even in the longterm, there is no difference between DT and TT, either in patient or in graft survival: at the doses we used, TT had a lower prevalence of late side effects than DT, however, long-term pure graft survival was better, although not significantly, in DT than in TT. The possibility of a safe shift from one regimen to the other one makes the two treatments complementary rather than alternatives.

Adult↗

PubMed1988

A prospective randomized trial of outpatient versus inpatient cardiac catheterization.

To evaluate the safety and cost of outpatient cardiac catheterization, we conducted a randomized trial at three hospitals of outpatient (n = 192) as compared with inpatient (n = 189) cardiac catheterization in low-risk patients. Outpatients had the following complication rates as compared with inpatients: hematoma, 12 versus 8.5 percent; numbness or weakness of extremity, 0.5 versus 1.6 percent; cold or blue extremity, 1.6 versus 1.1 percent; and acute myocardial infarction, 1.6 versus 0.5 percent. None of these differences were statistically significant. No deaths or strokes occurred in either group. Twenty-three patients (12 percent) assigned to the outpatient group required hospitalization because of complications of catheterization. In the outpatient group, the relative risk for hematoma was 1.42 (95 percent confidence interval, 0.77 to 2.29), and the relative risk for myocardial infarction within one week was 2.95 (95 percent confidence interval, 0.3 to 28.1). There were no significant differences between the two groups in whether they resumed normal activities or in the rates of rehospitalization within one week of the procedure. Total catheterization-related charges per patient were $679 lower for outpatients, with a savings in total hospital charges (including charges for subsequent therapeutic procedures) of $885 per patient. We conclude that elective cardiac catheterization as an outpatient procedure for selected patients is feasible and safe. Given the small size of our sample, however, we urge caution in interpreting these findings, since they do not exclude a small increase in complication rates with outpatient cardiac catheterization.

Ambulatory Care↗

PubMed1997

The Edinburgh Randomized Trial of Breast Cancer Screening.

This article presents additional follow-up analysis of women aged 45-49 from the Edinburgh Randomized Trial of Breast Cancer Screening. The screening protocol included four mammographic examinations at two-year intervals and seven annual clinical examinations. Altogether, 21,774 women aged 45-49 were recruited from 1978 to 1985 using cluster randomization. After 10-14 years of follow-up, breast cancer mortality has been reduced by 12% to 18% (rate ratios, with and without adjustment for socio-economic status, are 0.88 and 0.82 respectively, with 95% confidence intervals [CIs] of 0.55-1.41 and 0.51-1.32). These benefits are smaller than that reported previously with shorter follow-up. This article also presents data from an observational study that compared survival beyond baseline (50-52 years) of women first offered screening before and after age 50. Based on six-year data, the results suggest that earlier screening confers follow-up benefit (hazard ratio for later screening = 1.60; 95% CI: 0.96-2.67), but these findings are not statistically significant. The trial is too small to yield statistically significant results by itself, but can make useful contributions to overview and meta-analyses.

Adult↗

PubMed1998

A randomized trial comparing cyclosporine and steroids with cyclosporine, azathioprine, and steroids in cadaveric renal transplantation.

BACKGROUND: In renal transplantation, triple-drug therapy (low-dose cyclosporine [CsA] combined with azathioprine plus steroids) has been replacing double-drug therapy (CsA plus steroids) in clinical practice without much evidence in favor of either therapy. Previous trials comparing the two immunosuppressive regimens gave conflicting results. We attempted to determine whether triple therapy is at least equivalent to double therapy. METHODS: A randomized trial was performed in 250 adult cadaveric renal transplant recipients, comparing double therapy (CsA [10 mg/kg/day] plus prednisone) with triple therapy (CsA [6 mg/kg/day] plus azathioprine plus prednisone). The median follow-up time was 930 days. RESULTS: The incidence of acute rejection episodes refractory to treatment was 11% in double therapy and 4% in triple therapy (relative risk reduction: 64%; 95% confidence interval: 5-100%; P=0.035). Patients in the double therapy group required more intensive antirejection treatment, and their pathologic lesions were more severe. The proportion of patients with acute rejection was similar (double therapy: 45% vs. triple therapy: 40%) as was the incidence of chronic renal dysfunction (double therapy: 17% vs. triple therapy: 15.5%), the 4-year graft survival (double therapy: 71% vs. triple therapy: 83%, P=0.089), and patient survival (double therapy: 94% vs. triple therapy: 93%). In 29 patients (23%), 35 episodes of azathioprine-induced leukopenia were recorded, and in 9 of them azathioprine had to be discontinued. The incidence of other adverse events did not differ between the groups. CONCLUSIONS: Triple therapy caused fewer episodes of refractory acute rejection episodes and was as efficacious and safe as double therapy.

Acute Disease↗

PubMed1998

Six-month angiographic and clinical follow-up of patients prospectively randomized to receive either tirofiban or placebo during angioplasty in the RESTORE trial. Randomized Efficacy Study of Tirofiban for Outcomes and Restenosis.

OBJECTIVES: This study sought to investigate the effects of tirofiban versus placebo on the incidence of adverse cardiac outcomes and coronary artery restenosis at 6 months. BACKGROUND: Tirofiban is a highly selective, short-acting inhibitor of fibrinogen binding to platelet glycoprotein IIb/IIIa. In a recent clinical study, tirofiban reduced the incidence of adverse cardiovascular events at both 2 and 7 days after coronary angioplasty or directional coronary atherectomy. This reduction persisted but was no longer statistically significant at 30 days. METHODS: The Randomized Efficacy Study of Tirofiban for Outcomes and Restenosis (RESTORE) trial was a randomized, double-blind, placebo-controlled trial of tirofiban in patients undergoing balloon angioplasty or directional atherectomy within 72 h of presentation with either unstable angina pectoris or acute myocardial infarction. All patients received an initial bolus (10 microg/kg body weight over 3 min), followed by a 36-h infusion (0.15 microg/kg per min) of either tirofiban or placebo. RESULTS: At 6 months the composite end point (either death from any cause, new myocardial infarction, bypass surgery for angioplasty failure or recurrent ischemia, repeat target vessel angioplasty or stent insertion for actual or threatened abrupt closure) occurred in 1,070 placebo group patients (27.1%) and 1,071 tirofiban group patients (24.1%, p = 0.11). Analysis of 6-month coronary arteriograms by means of quantitative coronary arteriography showed no significant difference between placebo- and tirofiban-treated patients in either the incidence of a > or =50% diameter stenosis (57% vs. 51%, p = NS), a loss of > or =50% of lumen diameter gained (50% vs. 50%, p = NS) or a loss of > or =0.72 mm of lumen diameter (44% vs. 42%, p = NS). CONCLUSIONS: The 3% absolute reduction in the incidence of the composite end point at 6 months (27.1% placebo vs. 24.1% tirofiban) was similar to that previously reported at 2 days (8.7% vs. 5.4%, p < 0.005), and there does not appear to be any late effect of tirofiban on clinical end points between day 2 and 6 months. Tirofiban did not reduce the incidence of restenosis at 6 months when defined in a number of ways.

Adult↗

PubMed2000

Reducing adolescents' aggressive and hostile behaviors: randomized trial effects of a brief family intervention 4 years past baseline.

OBJECTIVE: To examine the long-term effects of a brief family intervention on aggressive and hostile behaviors of adolescents in the general population. DESIGN: Randomized trial including 22 public schools assigned to the Iowa Strengthening Families Program or a control condition. Analyses supported sample representativeness and failed to show differential attrition effects 4 years after baseline. INTERVENTION: Seven-session intervention for parents and their sixth-grade children. MEASURES: The multi-informant, multimethod measures included independent observer ratings of adolescent aggressive and hostile behaviors in adolescent-parent interactions, family-member report of aggressive and hostile behaviors in those interactions, and adolescent self-report of aggressive and destructive conduct across settings. Data were collected during the 6th (preintervention and postintervention), 7th, 8th, and 10th grades. RESULTS: All measures showed a generally positive trend in intervention-control group differences over time. During 10th grade, significant intervention-control differences were found for adolescent self-report of aggressive and destructive conduct (P =. 01), with relative reduction rates ranging from 31.7% to 77.0%. Significant differences were shown for observer-rated aggressive and hostile behaviors in adolescent-parent interactions (P =.01); differences in family member reports of those behaviors were not significant. Supplemental analyses of both interactional behavior measures, specific to parent sex, indicated significant experimental group differences in interactions with mothers (P =.04 for both measures) but not with fathers. CONCLUSIONS: Brief family competency-training interventions designed for general populations can reduce aggressive and hostile behaviors in adolescents' interactions with parents and adolescent aggressive behaviors outside of the home setting. Thus, this type of intervention has important public health implications. Arch Pediatr Adolesc Med. 2000;154:1248-1257.

Adolescent↗

PubMed2005

Effect of nutritional supplements on wound healing in home-nursed elderly: a randomized trial.

OBJECTIVE: The objective was to determine whether provision of oral nutritional supplements, delivered by community nurses, could improve nutritional status and wound healing in home-nursed elderly. METHODS: This was a double-blind, randomized trial in 50 elderly patients referred for wound management. Patients received 237 mL/d of 4 or 8 kJ/mL of an oral nutritional supplement for 4 wk. Nutritional status was measured with the Subjective Global Assessment and the Mini-Mental State Examination questionnaire to determine cognitive function and wound characteristics to assess healing. Differences between variables were examined with the Mann-Whitney or Student's t test for comparing two groups, one-way analysis of variance when there was more than two groups, and chi-square analysis for comparing two categorical variables. Associations between variables were examined with Pearson's correlation and regression analysis. RESULTS: At baseline, 34% subjects were moderately malnourished and 8% were severely malnourished. In both groups, there was significantly greater improvement in Mini-Mental State Examination scores at week 4 (95% confidence interval -2.0 to -0.001, P = 0.04) and a greater decrease in the wound effusion score (95% confidence interval -2.0 to 0.0, P = 0.045). Median length of stay did not differ between groups (P > 0.05). CONCLUSIONS: Malnutrition is common in elderly patients who are nursed at home for wound management. Provision of energy- and protein-dense oral supplements by community nurses is effective in improving some indices of wound healing and cognitive function in this group. Although further study is needed to determine the effect on length of stay, the nutritional needs of this vulnerable group should not be overlooked.

Administration, Oral↗

PubMed2000

Epidural analgesia for cephalic version: a randomized trial.

OBJECTIVE: To determine if epidural analgesia improves the success rate of external cephalic version. METHODS: Women with singleton fetuses in breech or transverse presentation of at least 37 weeks' gestation were offered enrollment in a randomized trial. Inclusion criteria included maternal age of 18 years or older, nonvertex presentation confirmed by ultrasound, intact membranes, reactive fetal nonstress test, and estimated fetal weight (EFW) between 2000 and 4000 g. Women in the epidural group had lumbar epidural catheters inserted, through which 2% lidocaine and 100 microg of fentanyl were infused. External cephalic version attempts were done with ultrasound guidance in a standard fashion for both groups. The primary outcome variable was the successful version of the fetus to a cephalic presentation. RESULTS: There were no statistically significant differences between groups in gestation at time of procedure, placental location, fetal lie, gravity, parity, EFW, or amniotic fluid index. External cephalic version was successful in 32 of 54 women (59%) with epidural anesthesia compared with 18 of 54 (33%) with no anesthesia (relative risk [RR] 1.8, 95% confidence interval [CI] 1.2, 2.8, P <.05). Vaginal delivery occurred in 29 of 54 women (54%) in the epidural group and 16 of 54 women (30%) in the control group (RR 1.9, 95% CI 1.2, 2.9, P <.05). CONCLUSION: Epidural analgesia increased the success rate of external cephalic version and the likelihood of subsequent vaginal delivery.

Adult↗

PubMed2004

Early consolidation by myeloablative radiochemotherapy followed by autologous stem cell transplantation in first remission significantly prolongs progression-free survival in mantle-cell lymphoma: results of a prospective randomized trial of the European MCL Network.

Mantle-cell lymphoma (MCL) is characterized by poor prognosis with a median survival of only 3 to 4 years. To improve clinical outcome, the European MCL Network initiated a randomized trial comparing consolidation with myeloablative radiochemotherapy followed by autologous stem cell transplantation (ASCT) to alpha-interferon maintenance (IFN alpha) in first remission. Patients 65 years of age or younger with advanced-stage MCL were assigned to ASCT or IFN alpha after achievement of complete or partial remission by a cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP)-like induction therapy. According to the International Prognostic Index (IPI), 43% of patients had a low-risk, 41% a low-intermediate, 11% a high-intermediate, and 6% a high-risk profile. Sixty-two of 122 patients proceeded to ASCT and 60 received IFN alpha. Patients in the ASCT arm experienced a significantly longer progression-free survival (PFS) with a median of 39 months compared with 17 months for patients in the IFN alpha arm (P = .0108). The 3-year overall survival (OS) was 83% after ASCT versus 77% in the IFN group (P = .18). Early consolidation by myeloablative radiochemotherapy followed by ASCT is feasible and results in a significant prolongation of PFS in advanced-stage MCL. Longer follow-up is needed to determine the effect on OS.

Adult↗

PubMed1984

Randomized trial of low- versus high-dose medroxyprogesterone acetate in the induction treatment of postmenopausal patients with advanced breast cancer.

In a randomized trial, 210 postmenopausal women with advanced measurable breast cancer were allocated to two different schedules of medroxyprogesterone acetate (MPA). In the induction phase they received either 1,000 mg intramuscular (IM) MPA (high dose) daily or 500 mg IM MPA (low dose) twice weekly for four weeks. The maintenance treatment consisted of 500 mg MPA IM once weekly for all patients. In total, 184 patients were considered evaluable. The response rate was significantly higher (p = 0.004) for patients receiving high-dose MPA (30 [33%] of 91) as compared to the women receiving the low-dose regimen (14 [15%] of 93) and was consistent across all prognostic subgroups. These prognostic subgroups included soft-tissue and osseous metastases, two metastatic sites, patients greater than 60 years, disease-free interval greater than 60 months, no prior chemotherapy, patients with a response to the last hormonal treatment before MPA, unknown estrogen receptors, and positive progestin receptors. The two different schedules of MPA did not influence the time to progression and the survival. Toxicity was similar in both regimens. These results confirm that a higher response rate can be achieved with a more intensive MPA schedule. This treatment may represent an ideal second-line choice in the endocrine therapy of advanced breast cancer; however, its role as a first-line treatment remains to be defined.

Age Factors↗

PubMed1995

Randomized trials of myocardial revascularization.

Over the past two decades there has been considerable refinement in randomized cardiovascular clinical trials. The common aim of randomized clinical trials of myocardial revascularization has been to understand the relative benefits of each technique on survival and nonfatal end points. The bypass surgery versus medicine trials that began in the 1970s provided evidence that the patients with advanced ischemic heart disease--three-vessel disease and/or substantially impaired LV function--have the most to gain from aggressive therapy (i.e., bypass surgery). In these cases, surgical revascularization provides survival benefit and has emerged as the reference standard for providing the most definitive revascularization. In long-term follow-up, however, surgery does not reduce the occurrence of myocardial infarction or angina compared with medical therapy. For patients with less extensive atherosclerosis and/or preserved ventricular function, trials comparing medical therapy, percutaneous coronary interventions, and bypass surgery have shown similar medium-term rates of death and infarction. In general, patients undergoing bypass surgery require the fewest subsequent antianginal medications, whereas patients undergoing PTCA require a moderate amount of antianginal medications, and patients treated solely with medical therapy require the most antianginal medications. Regardless, during long-term follow-up a similarly high number of patients are angina-free, although patients in the PTCA group require reintervention more often. Among patients treated percutaneously, techniques such as balloon angioplasty, directional atherectomy, stenting, rotablation, and laser may be considered. Compared with balloon angioplasty, greater acute gains in angiographic lumen have been obtained after directional atherectomy and stenting, but at the expense of increased periprocedural infarction after atherectomy, increased peripheral vascular complications after stenting, and increased late loss of lumen after both. Elective stenting has been associated with improved clinical outcome, whereas laser and rotational atherectomy have not, in comparison to balloon angioplasty. Restenosis remains the major limitation of all percutaneous approaches. Guidance for the individual patient is often less straightforward. Although general conclusions can be derived from patients cohorts in randomized trials, only a "gestalt" can be provided for the individual patient. For example, we have poor predictive capacity for restenosis, especially when this is recurrent despite repeated intervention. Only the demographic criteria of severe unstable angina and insulin-dependent diabetes mellitus are helpful in categorizing patients as "restenosis-prone." A substantial number of patients do not fit into the criteria adopted for entry into the revascularization trials--a point that is all too frequently forgotten.(ABSTRACT TRUNCATED AT 400 WORDS)

Coronary Disease↗

PubMed1987

Large fraction irradiation with or without misonidazole in advanced non-oat cell carcinoma of the lung: a phase III randomized trial of the RTOG. Radiation Therapy Oncology Group.

The Radiation Therapy Oncology Group (RTOG) investigated the use of misonidazole as an hypoxic cell sensitizer in a Phase III prospective randomized trial employing radiotherapy, 600 cGy twice weekly to a total of 3600 cGy with and without misonidazole in the treatment of locally advanced non-metastatic squamous cell, adeno, or large cell carcinoma of the lung. Between January 1980 and July 1983, 117 patients from 21 institutions were enrolled. One-hundred eight patients were evaluable; 53 in the combined treatment arm and 55 in the radiation alone arm. Grade 3 or worse complications associated with radiation occurred in 17% of patients. Esophageal toxicity accounted for the majority of complications. Two (4%) patients in the radiotherapy plus misonidazole group experienced grade 3 peripheral neurotoxicity. Complete or partial responses were produced in 58% of the patients with radiotherapy alone and 36% of those treated with radiotherapy plus misonidazole (p = 0.08). At the time of first progression, over 50% of the patients had persistent local disease. Median survival was 7 months regardless of treatment. Misonidazole in the dose and schedule employed did not enhance the effect of radiotherapy on either local tumor control or overall survival in patients with advanced lung cancer.

Adolescent↗

PubMed2004

Design and analysis of group-randomized trials: a review of recent methodological developments.

We review recent developments in the design and analysis of group-randomized trials (GRTs). Regarding design, we summarize developments in estimates of intraclass correlation, power analysis, matched designs, designs involving one group per condition, and designs in which individuals are randomized to receive treatments in groups. Regarding analysis, we summarize developments in marginal and conditional models, the sandwich estimator, model-based estimators, binary data, survival analysis, randomization tests, survey methods, latent variable methods and nonlinear mixed models, time series methods, global tests for multiple endpoints, mediation effects, missing data, trial reporting, and software. We encourage investigators who conduct GRTs to become familiar with these developments and to collaborate with methodologists who can strengthen the design and analysis of their trials.

Cluster Analysis↗

PubMed2000

Psychiatric hospitalizations, arrests, emergency room visits, and homelessness of clients with serious and persistent mental illness: findings from a randomized trial of two ACT programs vs. usual care.

OBJECTIVE: This investigation examined several adverse outcomes in clients with serious mental illness in a randomized trial of Assertive Community Treatment (ACT) versus usual care. METHOD: 163 subjects were randomized to one of two ACT experimental conditions (staffed by consumers or non-consumers) or usual community care. Conditions were compared on psychiatric hospitalization, emergency room visit, arrest, and homelessness, within the two-year study period. Demographic, program, and client variables were examined for significant associations with outcomes. RESULTS: Significant differences were found between ACT and usual care in time to first arrest, but not hospitalization, homelessness or ER visits. Shorter time to first hospitalization was associated with male gender, diagnoses other than schizophrenia, high psychiatric symptomatology and lower provider case load. ER visits were associated with increased client symptomatology. Shorter times to homelessness were predicted by poorer therapeutic alliance between case manager and clients. Shorter time to first arrest was predicted by client minority status and enrollment in usual care. CONCLUSIONS: The paucity of significant main effects may have been due to a prolonged "start-up" phase of the ACT programs, poor ACT implementation, restricted availability of psychiatric hospital beds, or changes in usual care services delivered over the study period.

Adult↗