Showing papers on "Randomized controlled trial published in 1995"

Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trials.

Abstract: Objective. —To determine if inadequate approaches to randomized controlled trial design and execution are associated with evidence of bias in estimating treatment effects. Design. —An observational study in which we assessed the methodological quality of 250 controlled trials from 33 meta-analyses and then analyzed, using multiple logistic regression models, the associations between those assessments and estimated treatment effects. Data Sources. —Meta-analyses from the Cochrane Pregnancy and Childbirth Database. Main Outcome Measures. —The associations between estimates of treatment effects and inadequate allocation concealment, exclusions after randomization, and lack of double-blinding. Results. —Compared with trials in which authors reported adequately concealed treatment allocation, trials in which concealment was either inadequate or unclear (did not report or incompletely reported a concealment approach) yielded larger estimates of treatment effects ( P P =.01), with odds ratios being exaggerated by 17%. Conclusions. —This study provides empirical evidence that inadequate methodological approaches in controlled trials, particularly those representing poor allocation concealment, are associated with bias. Readers of trial reports should be wary of these pitfalls, and investigators must improve their design, execution, and reporting of trials. ( JAMA . 1995;273:408-412)

A controlled trial to improve care for seriously ill hospitalized patients: The study to understand prognoses and preferences for outcomes and risks of treatments (SUPPORT)

Abstract: Objectives. —To improve end-of-life decision making and reduce the frequency of a mechanically supported, painful, and prolonged process of dying. Design. —A 2-year prospective observational study (phase I) with 4301 patients followed by a 2-year controlled clinical trial (phase II) with 4804 patients and their physicians randomized by specialty group to the intervention group (n=2652) or control group (n=2152). Setting. —Five teaching hospitals in the United States. Patients. —A total of 9105 adults hospitalized with one or more of nine life-threatening diagnoses; an overall 6-month mortality rate of 47%. Intervention. —Physicians in the intervention group received estimates of the likelihood of 6-month survival for every day up to 6 months, outcomes of cardiopulmonary resuscitation (CPR), and functional disability at 2 months. A specially trained nurse had multiple contacts with the patient, family, physician, and hospital staff to elicit preferences, improve understanding of outcomes, encourage attention to pain control, and facilitate advance care planning and patient-physician communication. Results. —The phase I observation documented shortcomings in communication, frequency of aggressive treatment, and the characteristics of hospital death: only 47% of physicians knew when their patients preferred to avoid CPR; 46% of do-not-resuscitate (DNR) orders were written within 2 days of death; 38% of patients who died spent at least 10 days in an intensive care unit (ICU); and for 50% of conscious patients who died in the hospital, family members reported moderate to severe pain at least half the time. During the phase II intervention, patients experienced no improvement in patient-physician communication (eg, 37% of control patients and 40% of intervention patients discussed CPR preferences) or in the five targeted outcomes, ie, incidence or timing of written DNR orders (adjusted ratio, 1.02; 95% confidence interval [Cl], 0.90 to 1.15), physicians' knowledge of their patients'preferences not to be resuscitated (adjusted ratio, 1.22; 95% Cl, 0.99 to 1.49), number of days spent in an ICU, receiving mechanical ventilation, or comatose before death (adjusted ratio, 0.97; 95% Cl, 0.87 to 1.07), or level of reported pain (adjusted ratio, 1.15; 95% Cl, 1.00 to 1.33). The intervention also did not reduce use of hospital resources (adjusted ratio, 1.05; 95% Cl, 0.99 to 1.12). Conclusions. —The phase I observation of SUPPORT confirmed substantial shortcomings in care for seriously ill hospitalized adults. The phase II intervention failed to improve care or patient outcomes. Enhancing opportunities for more patient-physician communication, although advocated as the major method for improving patient outcomes, may be inadequate to change established practices. To improve the experience of seriously ill and dying patients, greater individual and societal commitment and more proactive and forceful measures may be needed. (JAMA. 1995;274:1591-1598)

A Multidisciplinary Intervention to Prevent the Readmission of Elderly Patients with Congestive Heart Failure

Abstract: Background Congestive heart failure is the most common indication for admission to the hospital among older adults. Behavioral factors, such as poor compliance with treatment, frequently contribute to exacerbations of heart failure, a fact suggesting that many admissions could be prevented. Methods We conducted a prospective, randomized trial of the effect of a nurse-directed, multidisciplinary intervention on rates of readmission within 90 days of hospital discharge, quality of life, and costs of care for high-risk patients 70 years of age or older who were hospitalized with congestive heart failure. The intervention consisted of comprehensive education of the patient and family, a prescribed diet, social-service consultation and planning for an early discharge, a review of medications, and intensive follow-up. Results Survival for 90 days without readmission, the primary outcome measure, was achieved in 91 of the 142 patients in the treatment group, as compared with 75 of the 140 patients in the control...

Overview of randomized trials of angiotensin-converting enzyme inhibitors on mortality and morbidity in patients with heart failure

Abstract: Objective. —To evaluate the effect of angiotensin-converting enzyme (ACE) inhibitors on mortality and morbidity in patients with symptomatic congestive heart failure. Data Sources and Study Selection. —Data were obtained for all completed, published or unpublished, randomized, placebo-controlled trials of ACE inhibitors that were at least 8 weeks in duration and had determined total mortality by intention to treat, regardless of sample size. Trials were identified based on literature review and correspondence with investigators and pharmaceutical firms. Data Extraction. —Using standard tables, data were extracted by one author and confirmed where necessary by the other author or the principal investigator of the trial. Unpublished data were obtained by direct correspondence with the principal investigator of each study or pharmaceutical firm. Data Synthesis. —The data for each outcome were combined using the Yusuf-Peto adaptation of the Mantel-Haenszel method. Overall, there was a statistically significant reduction in total mortality (odds ratio [OR], 0.77; 95% confidence interval [CI], 0.67 to 0.88;P Conclusions. —Total mortality and hospitalization for congestive heart failure are significantly reduced by ACE inhibitors with consistent effects in a broad range of patients. (JAMA. 1995;273:1450-1456)

A prospective randomized trial

Abstract: Objective: This study compares outcomes following open and laparoscopic partial posterior fundoplication for gastroesophageal reflux disease concerning perioperative course, postoperative complications, symptomatic relief, recurrent disease, and the need for reinterventional surgery. Methods: A prospective randomized trial was performed. Pre- and postoperative testing included endoscopy, esophageal function testing, patient questionnaire, and clinical assessment. Patients were followed for three years. Materials: Ninety-three patients were randomized to open and 99 to laparoscopic surgery. Results: Complication rates were higher, and length of stay (LOS) [5 (3–36) vs 3 (1–12) days] and time off work [42 (12–76) vs 28 (0–108) days] was longer in the open group (p < 0.01). Early side effects and recurrences were more common (p < 0.05) in the laparoscopic group. One patient in the open group and 8 patients in the laparoscopic group required surgery for recurrent disease and 7 patients required surgery for incisional hernias after open surgery. Overall, at one and three years, there were no differences in patientassessed satisfactory outcome (93.5/93.5 vs 88.8/ 90.8%) or reflux control (p = 0.53) between the open and laparoscopic groups. Conclusions: The finding of fewer general complications, shorter length of stay and recovery, similar need for reoperations, and comparable 3-year outcomes, makes the laparoscopic approach the primary choice when considering surgical options for the treatment of gastroesophageal reflux disease (GERD).

Collaborative management to achieve treatment guidelines : impact on depression in primary care

Abstract: Objective. —To compare the effectiveness of a multifaceted intervention in patients with depression in primary care with the effectiveness of "usual care" by the primary care physician. Design. —A randomized controlled trial among primary care patients with major depression or minor depression. Patients. —Over a 12-month period a total of 217 primary care patients who were recognized as depressed by their primary care physicians and were willing to take antidepressant medication were randomized, with 91 patients meeting criteria for major depression and 126 for minor depression. Interventions. —Intervention patients received increased intensity and frequency of visits over the first 4 to 6 weeks of treatment (visits 1 and 3 with a primary care physician, visits 2 and 4 with a psychiatrist) and continued surveillance of adherence to medication regimens during the continuation and maintenance phases of treatment. Patient education in these visits was supplemented by videotaped and written materials. Main Outcome Measures. —Primary outcome measures included short-term (30-day) and long-term (90-day) use of antidepressant medication at guideline dosage levels, satisfaction with overall care for depression and antidepressant medication, and reduction in depressive symptoms. Results. —In patients with major depression, the intervention group had greater adherence than the usual care controls to adequate dosage of antidepressant medication for 90 days or more (75.5% vs 50.0%;P Conclusion. —A multifaceted intervention consisting of collaborative management by the primary care physician and a consulting psychiatrist, intensive patient education, and surveillance of continued refills of antidepressant medication improved adherence to antidepressant regimens in patients with major and with minor depression. It improved satisfaction with care and resulted in more favorable depressive outcomes in patients with major, but not minor, depression. (JAMA. 1995;273:1026-1031)

Predictors of 30-Day Mortality in the Era of Reperfusion for Acute Myocardial Infarction Results From an International Trial of 41 021 Patients

Abstract: Background Despite remarkable advances in the treatment of acute myocardial infarction, substantial early patient mortality remains. Appropriate choices among alternative therapies and the use of clinical resources depend on an estimate of the patient's risk. Individual patients reflect a combination of clinical features that influence prognosis, and these factors must be appropriately weighted to produce an accurate assessment of risk. Prior studies to define prognosis either were performed before widespread use of thrombolysis or were limited in sample size or spectrum of data. Using the large population of the GUSTO-I trial, we performed a comprehensive analysis of relations between baseline clinical data and 30-day mortality and developed a multivariable statistical model for risk assessment in candidates for thrombolytic therapy. Methods and Results For the 41 021 patients enrolled in GUSTO-I, a randomized trial of four thrombolytic strategies, relations between clinical descriptors routinely collected at initial presentation, and death within 30 days (which occurred in 7% of the population) were examined with both univariable and multivariable analyses. Variables studied included demographics, history and risk factors, presenting characteristics, and treatment assignment. Risk modeling was performed with logistic multiple regression and validated with bootstrapping techniques. Multivariable analysis identified age as the most significant factor influencing 30-day mortality, with rates of 1.1% in the youngest decile ( 75 (adjusted chi(2)=717, P<.0001). Other factors most significantly associated with increased mortality were lower systolic blood pressure (chi(2)=550, P<.0001), higher Killip class (chi(2)=350, P<.0001), elevated heart rate (chi(2)=275, P<.0001), and anterior infarction (chi(2)=143, P<.0001). Together, these five characteristics contained 90% of the prognostic information in the baseline clinical data. Other significant though less important factors included previous myocardial infarction, height, time to treatment, diabetes, weight, smoking status, type of thrombolytic, previous bypass surgery, hypertension, and prior cerebrovascular disease. Combining prognostic variables through logistic regression, we produced a validated model that stratified patient risk and accurately estimated the likelihood of death. Conclusions The clinical determinants of mortality in patients treated with thrombolytic therapy within 6 hours of symptom onset are multifactorial and the relations complex. Although a few variables contain most of the prognostic information, many others contribute additional independent prognostic information. Through consideration of multiple characteristics, including age, medical history, physiological significance of the infarction, and medical treatment, the prognosis of an individual patient can be accurately estimated.

Long-term follow-up results of a randomized drug abuse prevention trial in a white middle-class population

Abstract: Objective. —To evaluate the long-term efficacy of a school-based approach to drug abuse prevention. Design. —Randomized trial involving 56 public schools that received the prevention program with annual provider training workshops and ongoing consultation, the prevention program with videotaped training and no consultation, or "treatment as usual" (ie, controls). Follow-up data were collected 6 years after baseline using school, telephone, and mailed surveys. Participants. —A total of 3597 predominantly white, 12th-grade students who represented 60.41% of the initial seventh-grade sample. Intervention. —Consisted of 15 classes in seventh grade, 10 booster sessions in eighth grade, and five booster sessions in ninth grade, and taught general "life skills" and skills for resisting social influences to use drugs. Measures. —Six tobacco, alcohol, and marijuana use self-report scales were recoded to create nine dichotomous drug use outcome variables and eight polydrug use variables. Results. —Significant reductions in both drug and polydrug use were found for the two groups that received the prevention program relative to controls. The strongest effects were produced for individuals who received a reasonably complete version of the intervention—there were up to 44% fewer drug users and 66% fewer polydrug (tobacco, alcohol, and marijuana) users. Conclusions. —Drug abuse prevention programs conducted during junior high school can produce meaningful and durable reductions in tobacco, alcohol, and marijuana use if they (1) teach a combination of social resistance skills and general life skills, (2) are properly implemented, and (3) include at least 2 years of booster sessions. ( JAMA . 1995;273:1106-1112)

Patient Empowerment: Results of a randomized controlled trial

Abstract: OBJECTIVE The purpose of this study was to determine if participation in a patient empowerment program would result in improved psychosocial self-efficacy and attitudes toward diabetes, as well as a reduction in blood glucose levels. RESEARCH DESIGN AND METHODS This study was conducted as a randomized, wait-listed control group trial. The intervention group received a six-session (one session per week) patient empowerment education program; the control group was assigned to a wait-list. At the end of 6 weeks, the control group completed the six-session empowerment program. Six weeks after the program, both groups provided follow-up data. RESULTS The intervention group showed gains over the control group on four of the eight self-efficacy subscales and two of the five diabetes attitude subscales. Also, the intervention group showed a significant reduction in glycated hemoglobin levels. Within groups, analysis of data from all program participants showed sustained improvements in all of the self-efficacy areas and two of the five diabetes attitude subscales and a modest improvement in blood glucose levels. CONCLUSIONS This study indicated that patient empowerment is an effective approach to developing educational interventions for addressing the psychosocial aspects of living with diabetes. Furthermore, patient empowerment is conducive to improving blood glucose control. In an ideal setting, patient education would address equally blood glucose management and the psychosocial challenges of living with diabetes.

The efficacy of bacillus Calmette-Guérin vaccination of newborns and infants in the prevention of tuberculosis : meta-analyses of the published literature

Abstract: Objective. To quantify the efficacy of vaccination of infants with bacillus Calmette-Guerin (BCG) against tuberculosis. Data sources. MEDLINE with index terms BCG vaccine, tuberculosis, and human; lists of all known studies provided by experts at the Centers for Disease Control and Prevention, the World Health Organization, and other organizations. Study selection. A total of 1264 articles and abstracts were reviewed for details on BCG vaccination, the availability of concurrent vaccinated and unvaccinated groups, and a tuberculosis outcome. Seventy articles were reviewed in depth for method of vaccine allocation used to create comparable groups, age at vaccination of study participants, comparability of surveillance and follow-up of recipient and concurrent control groups in trials, an appropriately defined control group in case-control studies, and outcome measures (tuberculosis cases and/or deaths). Five prospective trials and eleven case-control studies of vaccination during infancy were included in the present analyses. Data extraction. We recorded study design, age range of study population, number of patients enrolled, efficacy of vaccine, location of the study, and a series of items to assess the potential for bias in study design, follow-up, and diagnosis. We extracted or computed vaccine efficacy by years since vaccination wherever possible. At least two readers independently extracted data and evaluated data validity. Data synthesis. The relative risk (RR) or odds ratio (OR) for tuberculosis in vaccinated versus unvaccinated infants was the measure of vaccine efficacy analyzed. A random-effects method estimated a weighted average RR or OR from data extracted from the trials and case-control studies. The protective effect was then computed by 1 - RR or 1 - OR. Overall, the protective effect of vaccination against cases of tuberculosis was 0.74 (95% confidence interval [95% CI], 0.62 to 0.83) when estimated from four randomized controlled trials, and 0.52 (95% CI, 0.38 to 0.64) when estimated from nine case-control studies. Five trials reporting deaths from tuberculosis showed a BCG protective effect of 0.65 (95% CI, 0.12 to 0.86), five studies reporting on meningitis showed a protective effect of 0.64 (95% CI, 0.30 to 0.82), and three studies of disseminated tuberculosis showed a protective effect of 0.78 (95% CI, 0.58 to 0.88). Three case-control studies included separate results for laboratory-confirmed cases of tuberculosis. These studies documented a protective effect of 0.83 (95% CI, 0.58 to 0.93). In a random-effects regression model of the nine case-control studies, study validity score explained 15% of the heterogeneity among study-estimated protective effects, suggesting that better studies reported greater efficacy. Three trials and six case-control studies provided some age-specific information that allowed us to examine the duration of BCG efficacy. Most of this evidence suggested that BCG efficacy may persist through 10 years after infant vaccination. Conclusion. BCG vaccination of newborns and infants significantly reduces the risk of tuberculosis—by over 50%, on average. Protection has been observed across many populations, study designs, and forms of tuberculosis. Rates of protection against cases that are confirmed by laboratory tests, reflecting reduced error in disease classification and consequently more accurate estimates of BCG efficacy, are highest at 83%.

Targeted prevention of unipolar depressive disorder in an at-risk sample of high school adolescents: a randomized trial of a group cognitive intervention.

Abstract: Objective This investigation attempted to prevent unipolar depressive episodes in a sample of high school adolescents with an elevated risk of depressive disorder. Method Adolescents at risk for future depressive disorder by virtue of having elevated depressive symptomatology were selected with a two-stage case-finding procedure. The Center for Epidemiologic Studies-Depression Scale (CES-D) was administered to 1,652 students; adolescents with elevated CES-D scores were interviewed with the Schedule for Affective Disorders and Schizophrenia for School-Age Children. Subjects with current affective diagnoses were referred to nonexperimental services. The remaining 150 consenting subjects were considered at risk for future depression and randomized to either a 15-session cognitive group prevention intervention or an “usual care” control condition. Subjects were reassessed for DSM-III-R diagnostic status after the intervention and at 6− and 12-month follow-up points. Results Survival analyses indicated a significant 12-month advantage for the prevention program, with affective disorder total incidence rates of 14.5% for the active intervention, versus 25.7% for the control condition. No differences were detected for nonaffective disorders across the study period. Conclusion Depressive disorder can be successfully prevented among adolescents with an elevated future risk.

Early enteral administration of a formula (Impact) supplemented with arginine, nucleotides, and fish oil in intensive care unit patients: results of a multicenter, prospective, randomized, clinical trial.

Abstract: OBJECTIVE To determine if early enteral feeding, in an intensive care unit (ICU) patient population, using a formula supplemented with arginine, dietary nucleotides, and fish oil (Impact), results in a shorter hospital stay and a reduced frequency of infectious complications, when compared with feeding a common use enteral formula (Osmolite.HN). DESIGN A prospective, randomized, double-blind, multicenter trial. SETTING ICUs in eight different hospitals. PATIENTS Of 326 patients enrolled in the study, 296 patients were eligible for analysis. They were admitted to the ICU after an event such as trauma, surgery, or sepsis, and met a risk assessment screen (Acute Physiology and Chronic Health Evaluation II [APACHE II] score of > or = 10, or a Therapeutic Intervention Scoring System score of > or = 20) and study eligibility requirements. Patients were stratified by age ( or = 60 yrs of age) and disease (septic or systemic inflammatory response syndrome). INTERVENTIONS Patients were enrolled and full-strength tube feedings were initiated within 48 hrs of the study entry event. Enteral feedings were advanced to a target volume of 60 mL/hr by 96 hrs of the event. One hundred sixty-eight patients were randomized to receive the experimental formula, and 158 patients were randomized to receive the common use control formula. MEASUREMENTS AND MAIN RESULTS Both groups tolerated early enteral feeding well, and the frequency of tube feeding-related complications was low. There were no significant differences in nitrogen balance between groups on study days 4 and 7. Patients receiving the experimental formula had a significant (p = .0001) increase in plasma arginine and ornithine concentrations by study day 7. Plasma fatty acid profiles demonstrated higher concentrations of linoleic acid (p < .01) in the patients receiving the common use formula and higher concentrations of eicosapentaenoic and docosahexaenoic acid (p < .01) in the patients receiving the experimental formula. The mortality rate was not different between the groups and was significantly (p < .001) lower than predicted by the admission severity scores in both feeding groups. In patients who received at least 821 mL/day of the experimental formula, the hospital median length of stay was reduced by 8 days (p < .05). In patients stratified as septic, the median length of hospital stay was reduced by 10 days (p < .05), along with a major reduction in the frequency of acquired infections (p < .01) in the patients who received the experimental formula. In the septic subgroup fed at least 821 mL/day, the median length of stay was reduced by 11.5 days, along with a major reduction in acquired infections (both p < .05) in the patients who received the experimental formula. CONCLUSIONS Early enteral feeding of the experimental formula was safe and well tolerated in ICU patients. In patients who received the experimental formula, particularly if they were septic on admission to the study, a substantial reduction in hospital length of stay was observed, along with a significant reduction in the frequency of acquired infections.

A randomized controlled trial of chronic vagus nerve stimulation for treatment of medically intractable seizures: The Vagus Nerve Stimulation Study Group*

Abstract: Article abstract—Preliminary reports have suggested that chronic, intermittent stimulation of the vagus nerve (VNS) is an alternative treatment for patients with medically refractory seizures. We performed a multicenter, randomized, controlled trial to evaluate the efficacy and safety of adjunctive VNS in patients with poorly controlled partial seizures. An implanted, programmable pacemaker-like device was connected to two stimulating electrodes wrapped around the left vagus nerve. One hundred fourteen patients were randomized to receive 14 weeks of high-level stimulation (presumed therapeutic dose) or low-level stimulation (presumed subtherapeutic dose) using a blinded, parallel study design. Seizure frequency was compared with a 12–week baseline. Mean reduction in seizure frequency was 24.5% for the “high stimulation group versus 6.1% for the 9low” stimulation group ( p = 0.01). Thirty-one percent of patients receiving high stimulation had a seizure frequency reduction of ≤50%, versus 13% of patients in the low group ( p = 0.02). Treatment emergent side effects were largely limited to a transient hoarseness occurring during the stimulation train. One patient with no previous history of cardiac disease experienced a myocardial infarction during the third month of vagal stimulation. VNS may be an effective alternative treatment for patients who have failed antiepileptic drug therapy and are not optimal candidates for epilepsy surgery.

Antibiotics in chronic obstructive pulmonary disease exacerbations. A meta-analysis.

Abstract: Objective. —A meta-analysis of randomized trials was performed to estimate the effectiveness of antibiotics in treating exacerbations of chronic obstructive pulmonary disease (COPD). Data Sources. —English-language studies published from 1955 through 1994 were retrieved using MEDLINE,Index Medicus, bibliographies, and consultation with experts. MEDLINE search terms included "COPD," "chronic bronchitis," and "antibiotic(s)." Study Selection. —Only randomized trials that enrolled patients having an exacerbation of COPD, used an antibiotic in the treatment group and placebo in the control group, and provided sufficient data to calculate an effect size were included in the meta-analysis. Data Extraction. —Descriptive and outcome data from each study were independently abstracted by two authors. Data Synthesis. —Overall summary effect size of the nine trials satisfying all inclusion criteria was 0.22 (95% confidence interval [CI], 0.10 to 0.34), indicating a small benefit in the antibiotic-treated group. Similar analysis of the six studies that provided data on peak expiratory flow rate changes revealed a summary effect size of 0.19 (95% CI, 0.03 to 0.35) and a summary change in peak expiratory flow rate of 10.75 L/min (95% CI, 4.96 to 16.54 L/min) in favor of the antibiotic-treated group. Sensitivity analyses did not significantly affect these results. Conclusions. —These analyses suggest a small but statistically significant improvement due to antibiotic therapy in patients with exacerbations of COPD. This antibiotic-associated improvement may be clinically significant, especially in patients with low baseline flow rates. (JAMA. 1995;273:957-960)

Preventing escalation in problem behaviors with high-risk young adolescents: immediate and 1-year outcomes.

Abstract: The study tested alternative intervention strategies to reduce escalation in problem behaviors among high-risk young adolescents (11 to 14 years old). A total of 158 families with young adolescents (male and female) participated in this study. Of these, 119 families were randomly assigned to 1 of the following intervention conditions: (a) parent focus, (b) teen focus, (c) parent and teen focus, (d) self-directed change (materials only). In addition, 39 families of young adolescents were recruited as a quasi-experimental control. Parent focus and teen focus interventions resulted in immediate beneficial effects in observed and reported family conflict. The parent intervention conditions showed immediate beneficial effects on behavior problems at school. Longitudinal trends suggest that the parent focus condition may reduce subsequent tobacco use, compared with all other approaches. Interventions that aggregated high-risk youths into groups, however, showed the highest escalations in tobacco use and problem behavior at school, beginning at termination and persisting to follow-up. These findings are discussed with respect to the need to re-evaluate strategies that aggregate high-risk youths into intervention programs and focus more on strategies to engage parents in prevention.

Long-term Effects of Varying Intensities and Formats of Physical Activity on Participation Rates, Fitness, and Lipoproteins in Men and Women Aged 50 to 65 Years

Abstract: Background Although exercise parameters such as intensity and format have been shown to influence exercise participation rates and physiological outcomes in the short term, few data are available evaluating their longer-term effects. The study objective was to determine the 2-year effects of differing intensities and formats of endurance exercise on exercise participation rates, fitness, and plasma HDL cholesterol levels among healthy older adults. Methods and Results Higher-intensity, group-based exercise training; higher-intensity, home-based exercise; and lower-intensity, home-based exercise were compared in a 2-year randomized trial. Participants were 149 men and 120 postmenopausal women 50 to 65 years of age who were sedentary and free of cardiovascular disease. Recruitment was achieved through a random digit-dial community telephone survey and media promotion. All exercise occurred in community settings. For higher-intensity exercise training, three 40-minute endurance training sessions per week wer...

Multiple-family groups and psychoeducation in the treatment of schizophrenia.

Abstract: Objective: To compare outcomes in psychoeducational multiple-family group treatment vs psychoeducational single-family treatment. Method: A total of 172 acutely psychotic patients, aged 18 to 45 years, withDSM-III-Rschizophrenic disorders were randomly assigned to single- or multiple-family psychoeducational treatment at six public hospitals in the state of New York. Psychotic relapse, symptom status, medication compliance, rehospitalization, and employment were assessed independently during 2 years of supervised treatment. Results: The multiple-family groups yielded significantly lower 2-year cumulative relapse rates than did the single-family modality (16% vs 27%) and achieved markedly lower rates in patients whose conditions had not remitted at index hospital discharge (13% vs 33%). The relapse hazard ratio between treatments was 1:3. The relapse rate for both modalities was less than half the expected rate (65% to 80% for 2 years) for patients receiving individual treatment and medication. Rehospitalization rates and psychotic symptoms decreased significantly, and medication compliance was high, to an equal degree in both modalities. Psychoeducational multiple-family groups were more effective than single-family treatment in extending remission, especially in patients at higher risk for relapse, with a cost-benefit ratio of up to 1:34. Conclusion: Psychoeducational multiple-family groups were more effective than single-family treatment in extending remission, especially in patients at higher risk for relapse, with a cost-benefit ratio of up to 1:34.

A controlled double blind study of azathioprine in the management of Crohn's disease.

Abstract: While immunosuppressive agents are used widely in the management of Crohn's disease, their efficacy has not been well established in randomised controlled trials. This study was designed to examine whether azathioprine increases remission rate when used in conjunction with a diminishing dose regimen of prednisolone over a period of 12 weeks. It further examined whether azathioprine offers any therapeutic advantage over placebo in the maintenance of remission in Crohn's disease over a period of 15 months. Sixty three patients with active Crohn's disease were treated with a 12 weeks diminishing dose of prednisolone and at the same time entered into a randomised, double blind 15 month trial of either azathioprine (2.5 mg/kg) or placebo. Remission rates between the two groups were compared at 12 weeks and at 15 months. There was no significant difference in the proportion of patients who had achieved and maintained remission by week 12 but at 15 months there was a highly significant difference in the proportion of patients in remission (42% receiving azathioprine v 7% receiving placebo), p = 0.001. Using life tables this beneficial effect was reflected as the difference in the median number of days on the trial (p = 0.02). There were significantly greater decreases over the trial period in the median erythrocyte sedimentation rate, C reactive protein, and leucocyte count in the azathioprine group. There were no cases of severe bone marrow suppression or clinical pancreatitis. In conclusion, azathioprine offers a therapeutic advantage over placebo in the maintenance of remission in Crohn's disease.

The effect of a 12-month exercise trial on balance, strength, and falls in older women: A randomized controlled trial.

Abstract: OBJECTIVE: To determine whether a 12-month program of regular exercise can improve balance, reaction time, neuromuscular control, and muscle strength and reduce the rate of falling in older women. DESIGN: A randomized, controlled trial of 12 months duration. SETTING: Conducted as part of the Randwick Falls and Fractures Study in Sydney, Australia. PARTICIPANTS: One hundred ninety-seven women aged 60 to 85 years (mean age 71.6, SD = 5.4) who were randomly recruited from the community. OUTCOME MEASURES: Accidental falls, postural sway, reaction time, neuromuscular control, and lower limb muscle strength. MAIN RESULTS: Exercise and control subjects were tested before, midway through, and at the end of the trial. At initial testing, exercisers and controls performed similarly in all tests and were well matched in relevant health and lifestyle factors. The mean number of classes attended for the 75 exercise subjects who completed the program was 60.0 (range 26–82). At the end of the trial, the exercise subjects showed improved performance in all five strength measures, in reaction time, neuromuscular control, body sway on a firm surface with the eyes open, and body sway on a compliant surface with the eyes open and closed. In contrast, there were no significant improvements in any of the test measures in the controls. In one test measure, hip flexion strength, the exercisers showed continued improvement throughout the study year. There was no significant difference in the proportion of fallers between the exercise and control subjects. Interesting trends were evident, however, between falls frequency and adherence to the exercise program. CONCLUSIONS: These findings show that exercise can produce long-term benefits with regard to improving sensorimotor function in older persons. The findings also suggest that high compliance to an exercise program may reduce falls frequency, although further studies are required to conclusively demonstrate that exercise offers an effective means of preventing falls.

A randomized controlled trial of an HIV sexual risk-reduction intervention for young African-American women.

Abstract: Objective. —To evaluate the efficacy of a community-based social skills human immunodeficiency virus (HIV) prevention intervention to enhance consistent condom use. Design. —A randomized, single-blind controlled trial. Setting. —Bayview-Hunter's Point neighborhood of San Francisco, Calif, a predominantly African-American community that is economically disadvantaged. Participants. —A sample of 128 sexually active, heterosexual, African-American women 18 through 29 years of age was recruited using street outreach techniques. Participants completed a structured baseline interview; 100 women (78.1%) completed 3-month follow-up interviews. Intervention. —Women randomized to the social skills intervention completed five sessions that emphasized ethnic and gender pride, HIV risk—reduction information, sexual self-control, sexual assertiveness and communication skills, proper condom use skills, and developing partner norms supportive of consistent condom use. Women randomized to the HIV education condition participated in a single session that provided HIV risk—reduction information. Women randomized to the delayed HIV education control condition received no HIV risk—reduction information until all follow-up interviews were completed. Main Outcome Measures. —Consistent condom use, HIV risk—reduction knowledge, sexual self-control, sexual assertiveness, sexual communication, and partner norms supportive of consistent condom use. Results. —Compared with the delayed HIV education control condition, women in the social skills intervention demonstrated increased consistent condom use (adjusted odds ratio [OR], 2.1; 95% confidence interval [CI], 1.03 to 4.15;P=.04), greater sexual self-control (adjusted OR, 1.9; 95% CI, 1.00 to 3.60;P=.05), greater sexual communication (adjusted OR, 4.1; 95% CI, 1.67 to 10.01;P=.002), greater sexual assertiveness (adjusted OR, 1.8; 95% CI, 1.01 to 3.27;P=.05), and increased partners' adoption of norms supporting consistent condom use (adjusted OR, 2.1; 95% CI, 1.08 to 3.87;P=.03). No statistically significant differences in outcome variables were observed between the HIV education condition relative to the delayed HIV education control condition. Conclusion. —Community-based HIV risk—reduction programs that are gender relevant and culturally sensitive and provide social skills training can effectively enhance consistent condom use. (JAMA. 1995;274:1271-1276)

Randomised controlled trial comparing problem solving treatment with amitriptyline and placebo for major depression in primary care

Abstract: Objective: To determine whether, in the treatment of major depression in primary care, a brief psychological treatment (problem solving) was (a) as effective as antidepressant drugs and more effective than placebo; (b) feasible in practice; and (c) acceptable to patients. Design: Randomised controlled trial of problem solving treatment, amitriptyline plus standard clinical management, and drug placebo plus standard clinical management. Each treatment was delivered in six sessions over 12 weeks. Setting: Primary care in Oxfordshire. Subjects: 91 patients in primary care who had major depression. Main outcome measures: Observer and self reported measures of severity of depression, self reported measure of social outcome, and observer measure of psychological symptoms at six and 12 weeks; self reported measure of patient satisfaction at 12 weeks. Numbers of patients recovered at six and 12 weeks. Results: At six and 12 weeks the difference in score on the Hamilton rating scale for depression between problem solving and placebo treatments was significant (5.3 (95% confidence interval 1.6 to 9.0) and 4.7 (0.4 to 9.0) respectively), but the difference between problem solving and amitriptyline was not significant (1.8 (−1.8 to 5.5) and 0.9 (−3.3 to 5.2) respectively). At 12 weeks 60% (18/30) of patients given problem solving treatment had recovered on the Hamilton scale compared with 52% (16/31) given amitriptyline and 27% (8/30) given placebo. Patients were satisfied with problem solving treatment; all patients who completed treatment (28/30) rated the treatment as helpful or very helpful. The six sessions of problem solving treatment totalled a mean therapy time of 3 1/2 hours. Conclusions: As a treatment for major depression in primary care, problem solving treatment is effective, feasible, and acceptable to patients. Key messages Key messages Patient compliance with antidepressant treatment is often poor, so there is a need for a psychological treatment This study found that problem solving is an effective psychological treatment for major depression in primary care—as effective as amitriptyline and more effective than placebo Problem solving is a feasible treatment in primary care, being effective when given over six sessions by a general practitioner Problem solving treatment is acceptable to patients

An Analysis of the Effectiveness of Interventions Intended to Help People Stop Smoking

Abstract: In a systematic review of the efficacy of interventions intended to help people stop smoking, data have been analyzed from 188 randomized controlled trials. Following personal advice and encouragement to stop smoking given by physicians during a single routine consultation, an estimated 2% (95% confidence limits, 1%, 3%; P P =.05) but no greater than simple advice by a physician (2%); yet, these techniques are several times more expensive. The effect of hypnosis is unproved (no trials have used biochemical markers). Nicotine replacement therapy is effective in an estimated 13% of smokers who seek help in cessation; the effect is greater in those who are nicotine-dependent. Other pharmacological treatments are not of proven efficacy, and acupuncture is ineffective. Sudden cessation or gradual reduction in smoking are similar in their efficacy on average. Physicians should take time to advise all their patients who smoke to quit. Smokers who are intent on stopping should be given additional support and encouraged to use nicotine replacement therapy. (Arch Intern Med. 1995;155:1933-1941)

Subverting Randomization in Controlled Trials

Abstract: Recent empirical evidence supports the importance of adequate randomization in controlled trials. Trials with inadequate allocation concealment have been associated with larger treatment effects compared with trials in which authors reported adequate allocation concealment. While that provides empirical evidence of bias being interjected into trials, trial investigators rarely document the sensitive details of subverting the intended purpose of randomization. This article relates anonymous accounts of deciphering assignment sequences before allocation based on experiences acquired from epidemiologic workshops for physicians. These accounts run the gamut from simple to intricate operations, from transillumination of envelopes to searching for code in the office files of the principal investigator. They indicate that deciphering is something more frequent than a rare occurrence. These accounts prompt some methodological recommendations to help prevent deciphering. Randomized controlled trials appear to annoy human nature—if properly conducted, indeed they should. ( JAMA . 1995;274:1456-1458)

Large group community-based parenting programs for families of preschoolers at risk for disruptive behaviour disorders: utilization, cost effectiveness, and outcome.

Abstract: A significant percentage of children with disruptive behavior disorders do not receive mental health assistance. Utilization is lowest among groups whose children are at greatest risk. To increase the availability, accessibility, and cost efficacy of parent training programs, this prospective randomized trial compared a large group community-based parent training program to a clinic-based individual parent training (PT) programs. All families of junior kindergartners in the Hamilton public and separate school boards were sent a checklist regarding problems at home. Those returning questionnaires above the 90th percentile were block randomly assigned to: (1) a 12-week clinic-based individual parent training (Clinic/Individual), (2) a 12-week community-based large group parent training (Community/Group), or (3) a waiting list control condition. Immigrant families, those using English as a second language, and parents of children with severe behaviour problems were significantly more likely to enroll in Community/Groups than Clinic/Individual PT. Parents in Community/Groups reported greater improvements in behaviour problems at home and better maintenance of these gains at 6-month follow-up. A cost analysis showed that, with groups of 18 families, Community/Groups are more than six times as cost effective as Clinic/Individual programs.