Showing papers on "Randomized controlled trial published in 1993"
TL;DR: The SAPS II, based on a large international sample of patients, provides an estimate of the risk of death without having to specify a primary diagnosis, and is a starting point for future evaluation of the efficiency of intensive care units.
Abstract: Objective. —To develop and validate a new Simplified Acute Physiology Score, the SAPS II, from a large sample of surgical and medical patients, and to provide a method to convert the score to a probability of hospital mortality. Design and Setting. —The SAPS II and the probability of hospital mortality were developed and validated using data from consecutive admissions to 137 adult medical and/or surgical intensive care units in 12 countries. Patients. —The 13 152 patients were randomly divided into developmental (65%) and validation (35%) samples. Patients younger than 18 years, burn patients, coronary care patients, and cardiac surgery patients were excluded. Outcome Measure. —Vital status at hospital discharge. Results. —The SAPS II includes only 17 variables: 12 physiology variables, age, type of admission (scheduled surgical, unscheduled surgical, or medical), and three underlying disease variables (acquired immunodeficiency syndrome, metastatic cancer, and hematologic malignancy). Goodness-of-fit tests indicated that the model performed well in the developmental sample and validated well in an independent sample of patients (P=.883 andP=.104 in the developmental and validation samples, respectively). The area under the receiver operating characteristic curve was 0.88 in the developmental sample and 0.86 in the validation sample. Conclusion. —The SAPS II, based on a large international sample of patients, provides an estimate of the risk of death without having to specify a primary diagnosis. This is a starting point for future evaluation of the efficiency of intensive care units. (JAMA. 1993;270:2957-2963)
5,836 citations
TL;DR: The MRI results demonstrate that IFNB has made a significant impact on the natural history of MS in these patients and support the clinical results in showing a significant reduction in disease activity as measured by numbers of active scans and appearance of new lesions.
Abstract: We performed yearly MRI analyses on 327 of the total 372 patients in a multicenter, randomized, double-blind, placebo-controlled trial of interferon beta-1b (IFNB). Clinical results are presented in the preceding companion paper. Baseline MRI characteristics were the same in all treatment groups. Fifty-two patients at one center formed a cohort for frequent MRIs (one every 6 weeks) for analysis of disease activity. The MRI results support the clinical results in showing a significant reduction in disease activity as measured by numbers of active scans (median 80% reduction, p = 0.0082) and appearance of new lesions. In addition, there was an equally significant reduction in MRI-detected burden of disease in the treatment as compared with placebo groups (mean group difference of 23%, p = 0.001). These results demonstrate that IFNB has made a significant impact on the natural history of MS in these patients.
1,974 citations
TL;DR: Carotid endarterectomy reduced the overall incidence of ipsilateral neurologic events in a selected group of male patients with asymptomatic carotid stenosis, and overall mortality was primarily due to coronary atherosclerosis.
Abstract: Background The efficacy of carotid endarterectomy in patients with asymptomatic carotid stenosis has not been confirmed in randomized clinical trials, despite the widespread use of operative intervention in such patients. Methods We conducted a multicenter clinical trial at 11 Veterans Affairs medical centers to determine the effect of carotid endarterectomy on the combined incidence of transient ischemic attack, transient monocular blindness, and stroke. We studied 444 men with asymptomatic carotid stenosis shown arteriographically to reduce the diameter of the arterial lumen by 50 percent or more. The patients were randomly assigned to optimal medical treatment including antiplatelet medication (aspirin) plus carotid endarterectomy (the surgical group; 211 patients) or optimal medical treatment alone (the medical group; 233 patients). All the patients at each center were followed independently by a vascular surgeon and a neurologist for a mean of 47.9 months. Results The combined incidence of ipsilatera...
1,324 citations
TL;DR: Psychiatric interventions that enhance effective coping and reduce affective distress appear to have beneficial effects on survival but are not proposed as an alternative or independent treatment for cancer or any other illness or disease.
Abstract: Objectives: We evaluated recurrence and survival for 68 patients with malignant melanoma who participated in a 6-week structured psychiatric group intervention 5 to 6 years earlier, shortly after their diagnosis and initial surgical treatment. We also explored the role of several factors as possible predictors of outcome. Design: This was a randomized controlled experimental study. The Cox proportion hazards regression model was used to quantify the relationship between treatment and the outcomes adjusted by the covariates (age, sex, Breslow depth, tumor site, baseline Profile of Mood States Total Mood Disturbance, baseline active-behavioral coping, baseline natural killer cell activity, and treatment [ie, group intervention]). The stepwise procedure was used for covariate selection. Results: For control patients, there was a trend for recurrence (13/34) and a statistically significant greater rate of death (10/34) than for experimental patients (7/34 and 3/34, respectively). We found that being male and having a greater Breslow depth predicted greater recurrence and poorer survival. Analysis of multiple covariates found that only Breslow depth and treatment (ie, group intervention) were significant. Adjusting for Breslow depth, treatment effect remained significant. Finally, baseline affective distress and baseline coping were significant psychobehavioral predictors for recurrence and survival. Surprisingly, higher levels of baseline distress as well as baseline coping and enhancement of active-behavioral coping over time were predictive of lower rates of recurrence and death. Conclusion: Psychiatric interventions that enhance effective coping and reduce affective distress appear to have beneficial effects on survival but are not proposed as an alternative or independent treatment for cancer or any other illness or disease. However, the exact nature of this relationship warrants further investigation.
1,026 citations
TL;DR: Findings support the recommendations of the new fifth Joint National Committee report regarding treatment choices for people with stage 1 ("mild") hypertension, as an initial regimen was more effective in preventing cardiovascular and other clinical events than was nutritional-hygienic treatment alone.
Abstract: Objective. —To compare six antihypertensive interventions for the treatment of mild hypertension. Design. —Randomized, double-blind, placebo-controlled clinical trial. Setting. —Four hypertension screening and treatment centers in the United States. Participants. —Hypertensive men and women, aged 45 to 69 years, with diastolic blood pressure less than 100 mm Hg. Intervention. —Sustained nutritional-hygienic advice to all participants to reduce weight, dietary sodium intake, and alcohol intake, and increase physical activity. Participants were randomly allocated to take (1) placebo (n=234); (2) chlorthalidone (n=136); (3) acebutolol (n=132); (4) doxazosin mesylate (n=134); (5) amlodipine maleate (n=131); or (6) enalapril maleate (n=135). Main Outcome Measures. —Blood pressure, quality of life, side effects, blood lipid levels and analysis of other serum components, echocardiographic and electrocardiographic changes, and incidence of cardiovascular events over an average of 4.4 years of follow-up. Results. —Blood pressure reductions were sizable in all six groups, and were significantly greater for participants assigned to drug treatment than placebo ( — 15.9 vs — 9.1 mm Hg for systolic blood pressure and — 12.3 vs —8.6 mm Hg for diastolic blood pressure;p Conclusions. —As an initial regimen, drug treatment in combination with nutritional-hygienic intervention was more effective in preventing cardiovascular and other clinical events than was nutritional-hygienic treatment alone. Drug-treatment group differences were minimal. Pending results from large-scale clinical trials to evaluate drug treatments for their effect on cardiovascular clinical events, these findings support the recommendations of the new fifth Joint National Committee report regarding treatment choices for people with stage 1 ("mild") hypertension. (JAMA. 1993;270:713-724)
970 citations
TL;DR: Perioperative increase of oxygen delivery with dopexamine hydrochloride significantly reduces mortality and morbidity in high-risk surgical patients.
Abstract: Objective —To assess the effect of deliberate perioperative increase in oxygen delivery on mortality and morbidity in patients who are at high risk of both following surgery Design —Prospective, randomized clinical trial Setting —A teaching hospital general intensive care unit, London, England Patients —A total of 107 surgical patients, who were assessed as high risk from previously identified criteria, were studied during an 18-month period Interventions —Patients were randomly assigned to a control group (n=54) that received best standard perioperative care, or to a protocol group (n=53) that, in addition, had deliberate increase of oxygen delivery index to greater than 600 mL/min per square meter by use of dopexamine hydrochloride infusion Outcome Measures —Mortality and complications were assessed to 28 days postoperatively Results —Groups were similar with respect to demographics, admission criteria, operation type, and admission hemodynamic variables Groups were treated similarly to maintain blood pressure, arterial saturation, hemoglobin concentration, and pulmonary artery occlusion pressure; however, once additional treatment with dopexamine hydrochloride had been given, the protocol group had significantly higher oxygen delivery preoperatively (median, 597 vs 399 mL/min per square meter;P Conclusion —Perioperative increase of oxygen delivery with dopexamine hydrochloride significantly reduces mortality and morbidity in high-risk surgical patients (JAMA 1993;270:2699-2707)
934 citations
TL;DR: The addition of basic counseling was associated with major increases in efficacy; and the addition of on-site professional services was even more effective.
Abstract: Objective. To examine whether the addition of counseling, medical care, and psychosocial services improves the efficacy of methadone hydrochloride therapy in the rehabilitation of opiate-dependent ...
792 citations
TL;DR: For women aged 40-49, randomized controlled trials consistently demonstrated no benefit from screening in the first 5-7 years after study entry, and only one trial (Health Insurance Plan) has data beyond 12 years of follow-up, and results showed a 25% decrease in mortality at 10-18 years.
Abstract: Background Over the past 30 years, eight major randomized controlled trials of breast cancer screening--with mammography and/or clinical breast examination--have been conducted. Results from several trials have been updated during the past year, and initial results of three other trials have been reported. Purpose The National Cancer Institute held an International Workshop on Screening for Breast Cancer in February 1993 to conduct a thorough and objective critical review of the world's most recent clinical trial data on breast cancer screening, consider the new evidence, assess the current state of knowledge, and identify issues needing further research. Methods Investigators representing the eight randomized controlled trials of breast cancer screening in women aged 40-74 presented published and unpublished data. Evidence relating to the effectiveness of breast cancer screening in different age groups, especially women aged 40-49, was presented. Results For women aged 40-49, randomized controlled trials consistently demonstrated no benefit from screening in the first 5-7 years after study entry. A meta-analysis of six trials found a relative risk of 1.08 (95% confidence interval = 0.85-1.39) after 7 years' follow-up. After 10-12 years of follow-up, none of four trials have found a statistically significant benefit in mortality; a combined analysis of Swedish studies showed a statistically insignificant 13% decrease in mortality at 12 years. Only one trial (Health Insurance Plan) has data beyond 12 years of follow-up, and results show a 25% decrease in mortality at 10-18 years. Statistical significance of this result is disputed, however. In women aged 50-69, all studies show mortality reductions; three of four studies show reductions of about 30% at 10-12 years after study entry. Results from two of these trials were statistically significant. Too few women over age 70 have been included in studies for adequate analysis. Conclusions For women aged 40-49, randomized controlled trials of breast cancer screening show no benefit 5-7 years after entry. At 10-12 years, benefit is uncertain and, if present, marginal; thereafter, it is unknown. For women aged 50-69, screening reduces breast cancer mortality by about a third. Currently available data for women age 70 or older are inadequate to judge the effectiveness of screening. Implications Randomized trials have provided stronger scientific evidence regarding the effectiveness of screening for breast cancer than for any other cancer. However, much still needs to be learned. Periodic gatherings of scientists in the field should speed the process.
782 citations
TL;DR: Regular use of sunscreens prevents the development of solar keratoses and, by implication, possibly reduces the risk of skin cancer in the long-term.
Abstract: Background The incidence of and mortality from skin cancer are increasing in many countries. In view of the added concern about ozone depletion, many organizations are promoting the regular use of sunscreens to prevent skin cancer, despite the absence of evidence that these products have this effect. Solar (actinic) keratosis is a precursor of squamous-cell carcinoma of the skin. Methods We conducted a randomized, controlled trial of the effect on solar keratoses of daily use of a broad-spectrum sunscreen cream with a sun-protection factor of 17 in 588 people 40 years of age or older in Australia during one summer (September 1991 to March 1992). The subjects applied either a sunscreen cream or the base cream minus the active ingredients of the sunscreen to the head, neck, forearms, and hands. Results The mean number of solar keratoses increased by 1.0 per subject in the base-cream group and decreased by 0.6 in the sunscreen group (difference, 1.53; 95 percent confidence interval, 0.81 to 2.25). The sunscr...
708 citations
TL;DR: Use of LOCM may be beneficial in patients with existing renal failure, and the pooled odds of a rise in SCr level of more than 44 mumol/L with LOCM was three times that after HOCM.
Abstract: To determine whether low-osmolality contrast media (LOCM) are less nephrotoxic than high-osmolality contrast media (HOCM), the authors searched MEDLINE and EMBASE databases and other sources to find randomized trials with data collected on changes in glomerular filtration rate or serum creatinine (SCr) level with LOCM and HOCM. Forty-five trials were found. Data were unavailable from 14 trials. When the P values from the other 31 trials were pooled, an overall P value of .02 was found. Among 24 trials with available data, the mean change in SCr was 0.2-6.2 mumol/L less with LOCM than HOCM. Among 25 trials with available data, the pooled odds of a rise in SCr level of more than 44 mumol/L with LOCM was 0.61 (95% confidence interval [CI], 0.48-0.77) times that after HOCM. For patients with existing renal failure, this odds ratio was 0.5 (CI, 0.36-0.68), while it was 0.75 (CI, 0.52-1.1) in patients without prior renal failure. Greater changes in SCr level occurred only in those with existing renal failure and were less common with LOCM (odds ratio, 0.44; CI, 0.26-0.73). Use of LOCM may be beneficial in patients with existing renal failure.
679 citations
TL;DR: There was no improvement in outcome associated with initiating treatment before hospital arrival; however, treatment within 70 minutes of symptom onset--whether in the hospital or in the field--minimized the infarct process and its complications.
Abstract: Objective. —To determine the effect of prehospital-initiated vs hospital-initiated treatment of myocardial infarction on clinical outcome. Design. —Randomized, controlled clinical trial. Setting. —Multicenter study involving 19 hospitals and all paramedic systems in the Seattle, Wash, metropolitan area. Patients. —A total of 360 patients with symptoms for 6 hours or less, no risk factors for serious bleeding, and ST-segment elevation were selected by paramedics and a remote physician for inclusion into the trial. They represented 4% of patients with chest pain who were screened and 21% of those with acute infarction. Interventions. —Patients were allocated to have aspirin and alteplase treatment initiated before or after hospital arrival. Intravenous sodium heparin was administered to both groups in the hospital. Main Outcome Measure. —The primary endpoint was a ranked composite score (combining death, stroke, serious bleeding, and infarct size). The relation between time to treatment and outcome (composite score, infarct size, ejection fraction, and mortality) was also assessed. Results. — Initiating treatment before hospital arrival decreased the interval from symptom onset to treatment from 110 to 77 minutes (P Conclusion. —There was no improvement in outcome associated with initiating treatment before hospital arrival; however, treatment within 70 minutes of symptom onset—whether in the hospital or in the field—minimized the infarct process and its complications. (JAMA. 1993;270:1211-1216)
TL;DR: In this sample of patients with disseminated colorectal cancer the chemotherapy regimen was an effective form of palliative treatment and in patients with abnormal scores before treatment, quality of life seemed better in the chemotherapy arm.
Abstract: OBJECTIVES--To compare the length of survival and quality of life in patients given combination chemotherapy in addition to supportive care and in patients given only supportive care. DESIGN--Randomised study. SETTING--Gastrointestinal oncology departments. PATIENTS--40 previously untreated patients with histologically confirmed, measurable colorectal cancer that was locally recurrent or metastatic. INTERVENTIONS--Patients were allocated randomly to receive chemotherapy or only supportive care in a ratio of 2:1 according to performance status, metastatic disease of the liver, and weight loss in the six months before entering the study. Chemotherapy consisted of four week cycles of intravenous leucovorin (200 mg/m2/day) followed by 5-fluorouracil (550 mg/m2/day) and cisplatin (20 mg/m2/day), each drug being given on the first four days of the cycle. MAIN OUTCOME MEASURES--Length of survival and quality of life score with an optimised functional living index-cancer scale. RESULTS--Overall survival was significantly longer for patients given chemotherapy (11.0 months) than for those receiving supportive care alone (5.0 months; p = 0.006). Despite common association of chemotherapy with mild to moderate gastrointestinal symptoms, there was no significant difference between the two groups in global or subgroup quality of life scores. In patients with abnormal scores before treatment, quality of life seemed better in the chemotherapy arm. CONCLUSIONS--In this sample of patients with disseminated colorectal cancer the chemotherapy regimen was an effective form of palliative treatment.
TL;DR: It is indicated that external hip protectors can prevent hip fractures in nursing-home residents.
TL;DR: The routine use of class I antiarrhythmic agents after myocardial infarction is associated with increased mortality and the limited data on amiodarone appear promising.
Abstract: Objective. —To investigate the effects of prophylactic therapy with antiarrhythmic agents on mortality in patients with myocardial infarction. Data Sources and Study Selection. —Data were obtained from all completed, published or unpublished, randomized, parallel controlled trials of antiarrhythmic agents, regardless of sample size. Investigators were contacted for data on patients excluded after randomization. Data Extraction. —Data on mortality were extracted by one author and confirmed where necessary by the others. Data Synthesis. —Mortality data from 138 trials on 98 000 patients were combined by the Yusuf-Peto adaptation of the Mantel-Haenszel method. There were 660 deaths among 11 712 patients allocated to receive class I agents and 571 deaths among 11 517 corresponding control patients (51 trials: odds ratio [OR], 1.14;95% confidence interval [Cl], 1.01 to 1.28;P=03). Of 26 973 patients allocated to receive β-blockers (class II agents), 1464 died compared with 1727 deaths among 26 295 control patients (55 trials: OR, 0.81; 95% CI, 0.75 to 0.87;P=.00001). Of 778 patients allocated to receive amiodarone (a class III agent), 77 died compared with 101 deaths in 779 control patients (eight trials: OR, 0.71; 95% Cl, 0.51 to 0.97;P=.03). There were 982 deaths in 10 154 patients allocated to receive a class IV agent (calcium channel blockers) and 949 deaths in 10 188 control patients (24 trials: OR, 1.04; 95% CI, 0.95 to 1.14;P=.41). Conclusions. —The routine use of class I antiarrhythmic agents after myocardial infarction is associated with increased mortality. β-Blockers have been conclusively demonstrated to reduce mortality. The limited data on amiodarone appear promising. Data on calcium channel blockers remain unpromising. (JAMA. 1993;270:1589-1595)
TL;DR: The results confirm the common opinion that the adjuvant chemotherapy regimens prescribed in these trials, although effective in phase II studies, do not improve survival and indicate that postoperative chemotherapy in general offers no additional survival benefit for patients with curatively resected gastric cancer.
Abstract: PURPOSEAn overview is presented of reports published since 1980, in which postoperative adjuvant chemotherapy is compared with surgery alone for patients with gastric cancer. A MEDLINE literature review yielded 123 reports, 14 of which were relevant randomized trials; data from 11 of these trials were (or became) available for analysis of crude mortality odds. These 11 trials included 2,096 patients.METHODSOdds ratios were calculated by comparing the adjuvant treatment arm with the observation-only arm. Those odds ratios that could be considered homogeneous yielded an estimated common odds ratio of 0.88 (95% confidence interval [CI], 0.78 to 1.08), which was slightly, but far from significantly, in support of adjuvant treatment.RESULTSThe results confirm the common opinion that the adjuvant chemotherapy regimens prescribed in these trials, although effective in phase II studies, do not improve survival. Furthermore they indicate that postoperative chemotherapy in general offers no additional survival bene...
TL;DR: It is concluded that the addition of strontium-89 is an effective adjuvant therapy to local field radiotherapy reducing progression of disease as evidenced by new sites of pain and the requirement of further radiotherapy and improving quality-of-life and need for analgesic support in this group of patients.
Abstract: Purpose : A large proportion of the practice of radiotherapy in the management of metastatic adenocarcinoma of the prostate is associated with palliation of pain from osseous metastases and improving quality of life. Radiation therapy is well known to be effective in treating painful sites and may also be effective in reducing the propensity for adjuvantly treated disease to become symptomatic. Strontium-89 is a systemic radionuclide that has clinical efficacy in the palliation of pain from bony metastases. Methods and Materials : The study was a Phase-III randomized placebo control trial performed in eight Canadian Cancer Centers to evaluate the effectiveness of strontium-89 as an adjunct to local field radiotherapy. Patients with endocrine refractory metastatic prostate cancer received local field radiotherapy and either strontium-89 as a single injection of 10.8 mCi or placebo. Results : One hundred twenty-six patients were recruited. No significant differences in survival or in relief of pain at the index site where noted. Intake of analgesics over time demonstrated a significant reduction in the arm treated with strontium-89. Progression of pain as measured by sites of new pain or the requirement for radiotherapy showed statistically significant differences between the arms in favor of strontium-89. Tumor markers including prostate specific antigen, acid phosphatase, and alkaline phosphatase were also reduced in patients receiving strontium-89. A Quality-of-Life analysis was performed as a multivariate data set and demonstrated an overall superiority of strontium-89 with alleviation of pain and improvement in physical activity being statistically significant. Toxicity was evaluated and demonstrated increased hematological toxicity in the group receiving strontium-89. Conclusions : It is concluded that the addition of strontium-89 is an effective adjuvant therapy to local field radiotherapy reducing progression of disease as evidenced by new sites of pain and the requirement of further radiotherapy and improving quality-of-life and need for analgesic support in this group of patients.
TL;DR: This multicomponent behavioral treatment appears to be an effective intervention for retaining outpatients in treatment and establishing cocaine abstinence.
Abstract: Objective The authors compared the efficacy of a multicomponent behavioral treatment and drug abuse counseling for cocaine-dependent individuals. Method The 38 patients were enrolled in outpatient treatment and were randomly assigned to the two treatments. Counseling in the behavioral treatment was based on the community reinforcement approach, while the drug abuse counseling was based on the disease model of dependence and recovery. Patients in the behavioral, but not the drug counseling, treatment also received incentives contingent on submitting cocaine-free urine specimens. Results Of the 19 patients who received behavioral treatment, 58% completed 24 weeks of treatment, versus 11% of the patients who received counseling. In the behavioral treatment group 68% and 42% of the patients achieved at least 8 and 16 weeks of documented continuous cocaine abstinence, respectively, versus 11% and 5% in the drug abuse counseling group. Conclusions This multicomponent behavioral treatment appears to be an effective intervention for retaining outpatients in treatment and establishing cocaine abstinence.
TL;DR: A controlled trial of two cognitive-behavioural treatments to alleviate residual hallucinations and delusions in schizophrenic patients showed significant reductions in pyschotic symptoms compared with those in the waiting period, who showed no improvement.
Abstract: Despite neuroleptic medication, many schizophrenic patients continue to experience residual positive psychotic symptoms. These residual symptoms cause distress and disability. We report a controlled trial of two cognitive-behavioural treatments to alleviate residual hallucinations and delusions. Forty-nine patients were recruited into the trial, of whom 27 entered the trial and completed post-treatment assessment, and 23 were reassessed at six-month follow-up. Patients were randomly allocated to either coping strategy enhancement (CSE) or problem solving (PS). Half the patients were allocated to a high-expectancy positive demand condition and half to a counter-demand condition to evaluate expectation of improvement. Patients receiving either cognitive-behavioural treatment showed significant reductions in psychotic symptoms compared with those in the waiting period, who showed no improvement. There was some evidence, although equivocal, that patients receiving CSE improved more than those receiving PS. There was no evidence that improvements generalised to negative symptoms or social functioning, nor was there evidence that expectancy of treatment benefit contributed to the treatment effect.
TL;DR: In this article, the authors evaluated the effect of a patient, health care provider, and systems intervention on the prevalence of risk factors for lower extremity amputation in patients with non-insulin-dependent diabetes.
Abstract: OBJECTIVE To evaluate the effect of a patient, health care provider, and systems intervention on the prevalence of risk factors for lower extremity amputation in patients with non-insulin-dependent diabetes. DESIGN Blinded, randomized, controlled trial. SETTING Academic general medicine practice. PARTICIPANTS Of the 395 patients with non-insulin-dependent diabetes who underwent the initial patient assessment, 352 completed the study. INTERVENTION The 12-month intervention was multifaceted. Patients received foot-care education and entered into a behavioral contract for desired self-foot care, which was reinforced through telephone and postcard reminders. Health care providers were given practice guidelines and informational flow sheets on foot-related risk factors for amputation in diabetic patients. In addition, the folders for intervention patients had special identifiers that prompted health care providers to: 1) ask that patients remove their footwear, 2) perform foot examinations, and 3) provide foot-care education. RESULTS Patients receiving the intervention were less likely than control patients to have serious foot lesions (baseline prevalence, 2.9%; odds ratio, 0.41 [95% CI, 0.16 to 1.00]; P = 0.05) and other dermatologic abnormalities. Also, they were more likely to report appropriate self-foot-care behaviors, to have foot examinations during office visits (68% compared with 28%; P < 0.001), and to receive foot-care education from health care providers (42% compared with 18%; P < 0.001). Physicians assigned to intervention patients were more likely than physicians assigned to control patients to examine patients' feet for ulcers, pulses, and abnormal dermatologic conditions and to refer patients to the podiatry clinic (10.6% compared with 5.0%; P = 0.04). CONCLUSIONS An intervention designed to reduce risk factors for lower extremity amputations positively affected patient self-foot-care behavior as well as the foot care given by health care providers and reduced the prevalence of lower extremity clinical disease in patients with diabetes.
Journal Article•
TL;DR: Regular aspirin use, at a dose adequate for preventing myocardial infarction, was not associated with a substantial reduction in the incidence of colorectal cancer during 5 years of randomized treatment and follow-up.
Abstract: Background Laboratory, clinical, and epidemiologic studies have recently suggested that regular use of aspirin can reduce colorectal cancer incidence or mortality. However, observational epidemiologic analyses have had limited opportunity to control for confounding bias or to specify aspirin doses used. Purpose Our purpose was to examine the relationship between regular use of low-dose aspirin and incidence of invasive and noninvasive colorectal tumors by utilizing data from the Physicians' Health Study, a randomized, double-blinded, placebo-controlled trial of aspirin and beta carotene. We also attempted to determine whether invasive cancers among aspirin users were associated with rectal bleeding and early stage at diagnosis. Methods The Physicians' Health Study includes 22071 U.S. male physicians. The aspirin arm was terminated in 1988 after a mean follow-up of 5 years. Stage at diagnosis and signs and/or symptoms during presentation were abstracted from medical records. Cox proportional hazards models were used to estimate relative risk (RR), 95% confidence intervals (CIs), and the association between aspirin and bleeding. Differences between aspirin and placebo groups in tumor risk over time were visualized with Kaplan-Meier curves. We assessed the association between aspirin and stage at diagnosis with a Mann-Whitney rank sum statistic for non-parametric comparison of two ordinal distributions. Results The RR of developing colorectal cancer for aspirin compared with placebo was 1.15 (95% CI = 0.80-1.65). For in situ cancers and polyps, the RR was 0.86 (95% CI = 0.68-1.10). There was no significant trend for decreasing RR by year of follow-up for invasive cancers (P = .09) or noninvasive tumors (P = .96). Aspirin and placebo groups did not differ in stage or prevalence of rectal bleeding at diagnosis. Conclusions Regular aspirin use, at a dose adequate for preventing myocardial infarction, was not associated with a substantial reduction in the incidence of colorectal cancer during 5 years of randomized treatment and follow-up. A small decrease in polyps in the aspirin group could not be reliably distinguished from a chance association. Our results suggest that among low-dose aspirin users, (a) colorectal cancer mortality is not likely to be reduced by earlier detection and (b) incidence is not likely to be increased due to aspirin-induced gastrointestinal bleeding. Implications The potential for a benefit from higher doses of aspirin or longer duration of use should be addressed by more detailed observational epidemiologic studies and prevention trials with longer follow-up of randomized participants.
TL;DR: A placebo-controlled, double-blind, randomized trial of prophylactic ganciclovir in CMV-seropositive allogeneic bone marrow transplants was initiated to prevent GVHD.
Abstract: Objective: To evaluate the efficacy and safety of ganciclovir for prevention of cytomegalovirus (CMV) infection and disease. Design: A randomized, placebo-controlled, double-blind trial. Setting: U...
TL;DR: The highly conditioned elderly women in this study had superior NK and T cell function when compared with their sedentary counterparts, despite no differences in circulating levels of lymphocyte subpopulations.
Abstract: The relationship between cardiorespiratory exercise, immune function, and upper respiratory tract infection (URTI) was studied in elderly women utilizing a randomized controlled experimental design with a follow-up of 12 wk. Thirty-two sedentary, elderly Caucasian women, 67-85 yr of age, who met specific selection criteria, were randomized to either a walking or calisthenic group; 30 completed the study. Twelve highly conditioned elderly women, 65-84 yr of age, who were active in endurance competitions, were recruited at baseline for cross-sectional comparisons. Intervention groups exercised 30-40 min, 5 d.wk-1, for 12 wk, with the walking group training at 60% heart rate reserve and the calisthenic group engaging in mild range-of-motion and flexibility movements that kept their heart rates close to resting levels. At baseline, the highly conditioned subjects exhibited superior NK (119 +/- 13 vs 77 +/- 8 lytic units, P < 0.01) and T (33.3 +/- 4.9 vs 21.4 +/- 2.1 cpm x 10(-3) using PHA, P < 0.05) cell function, despite no differences in circulating levels of lymphocyte subpopulations. Twelve weeks of moderate cardiorespiratory exercise improved the VO2max of the sedentary subjects 12.6%, but did not result in any improvement in NK cell activity or T cell function. Incidence of URTI was lowest in the highly conditioned group and highest in the calisthenic control group during the 12-wk study, with the walkers in an intermediate position (chi-square = 6.36, P = 0.042). In conclusion, the highly conditioned elderly women in this study had superior NK and T cell function when compared with their sedentary counterparts.(ABSTRACT TRUNCATED AT 250 WORDS)
TL;DR: Meta-analyses performed using data from four prospective investigations in which a total of 997 initiated studies were followed to learn of study results, publication status, and reasons for nonpublication indicate that there is a positive association between "significant" study results and publication.
Abstract: Conclusions about the efficacy and safety of medical interventions are based on data presented in the scientific literature. The validity of these conclusions is threatened if publication bias results from investigators or editors making decisions about publishing study results on the basis of the direction or strength of the study findings. This paper reports meta-analyses performed using data from four prospective investigations in which a total of 997 initiated studies were followed to learn of study results, publication status, and reasons for nonpublication. The analysis indicates that there is a positive association between "significant" study results and publication (OR = 2.88; 95% confidence interval [CI] 2.13 to 3.90). When the analysis was restricted to controlled trials (n = 280), an even stronger relationship between "significant" results and publication was observed (OR = 6.15; 95% CI 2.24 to 16.92), with randomized trials (n = 200) apparently no less susceptible to publication bias than controlled trials in general (OR = 8.72; 95% CI 1.91 to 39.81). In every case, failure to publish was investigator-based, and not due to editorial decisions. The results of clinical trials should not be suppressed in this way. Development of registration systems for randomized trials is essential if this problem is to be minimized in future.
TL;DR: Patient preference strongly favors PCA over conventional analgesia, and patients using PCA also obtain better pain relief than those using conventional analgesIA, without an increase in side effects.
TL;DR: This article evaluated the effectiveness of group cognitive-behavioral treatment (CBT) and group interpersonal psychotherapy (IPT) for binge eating in women with nonpurging bulimia.
Abstract: This study evaluated the effectiveness of group cognitive-behavioral treatment (CBT) and group interpersonal psychotherapy (IPT) for binge eating. Fifty-six women with nonpurging bulimia were randomly assigned to 1 of 3 groups: CBT, IPT, or a wait-list control (WL). Treatment was administered in small groups that met for 16 weekly sessions. At posttreatment, both group CBT and group IPT treatment conditions showed significant improvement in reducing binge eating, whereas the WL condition did not. Binge eating remained significantly below baseline levels for both treatment conditions at 6-month and 1-year follow-ups. These data support the central role of both eating behavior and interpersonal factors in the understanding and treatment of bulimia.
TL;DR: Findings suggest that nurses can intervene to maintain or restore attentional capacity in women after surgery for localized breast cancer and suggest the theoretical basis for further development of attention-restoring interventions in patients with cancer is discussed.
Abstract: Developing interventions to maintain or restore attentional capacity during demanding phases of illness will help promote effective functioning in people with cancer. This study tested the effects of an experimental intervention aimed at maintaining or restoring attentional capacity in 32 women during the 3 months after surgery for localized (Stage I or II) breast cancer. The intervention was designed to minimize or prevent attentional fatigue through regular participation in activities that engage fascination and have other restorative properties. Attentional capacity was assessed using objective and subjective measures at four time points, approximately 3, 18, 60, and 90 days after breast cancer surgery. After the first observation, subjects were randomly assigned to receive the intervention (n = 16) or not to receive intervention (n = 16). Repeated measures ANOVA showed a significant interaction of experimental intervention and time on attentional capacity. Specifically, subjects in the intervention group showed significant improvement in attentional capacity over the four time points, while the nonintervention group showed a pattern of inconsistent performance over time. Findings suggest that nurses can intervene to maintain or restore attentional capacity in women after surgery for localized breast cancer. The theoretical basis for further development of attention-restoring interventions in patients with cancer is discussed.
TL;DR: It is suggested that long-term adjuvant treatment with tamoxifen may result in substantial reduction of cardiac morbidity in patients with low risk of death from breast cancer as well as in women in chemopreventive studies who have high risk of developing breast cancer.
Abstract: BACKGROUND Tamoxifen, which binds to estrogen receptors, is widely used as adjuvant therapy after surgery for early-stage breast cancer. Our previous randomized trial of adjuvant tamoxifen therapy for breast cancer showed a significant decrease of new, contralateral breast cancers in patients who received tamoxifen. Tamoxifen may also influence risk factors for cardiac and thromboembolic disease (e.g., serum cholesterol and antithrombin III). PURPOSE The purpose of this study was to assess morbidity from cardiac and thromboembolic disease among 2365 postmenopausal patients with early-stage breast cancer in the Stockholm randomized trial of adjuvant tamoxifen (40 mg daily for 2 or 5 years) versus no adjuvant endocrine therapy. Patients were entered in the study from November 1976 through December 1988. METHODS In our retrospective study, the analysis of morbidity was based on data from a computerized, population-based register of hospital admissions and discharge diagnoses. Mortality data were obtained from the Swedish National Central Bureau of Statistics. In the Stockholm study, treatment with tamoxifen was initiated within 4-6 weeks of modified radical mastectomy or breast-conserving surgery including axillary lymph node dissection and postoperative radiation therapy to the breast. In that randomized trial, 755 patients at low risk of death from breast cancer received adjuvant tamoxifen only; 760 received no treatment. In addition, 628 high-risk patients were randomly assigned to receive adjuvant chemotherapy plus tamoxifen (173 patients) or postoperative radiotherapy plus tamoxifen (151) or, as a control, to receive chemotherapy (171) or postoperative radiation therapy (133), both without tamoxifen or other endocrine therapy. Median follow-up was 6 years. RESULTS Tamoxifen therapy resulted in a statistically significant reduced incidence of hospital admissions due to cardiac disease. The relative hazard (tamoxifen for 2 or 5 years versus control) was 0.68 (95% confidence interval [CI] = 0.48-0.97; P = .03). In the randomized comparison of 5 versus 2 years of tamoxifen, there was a statistically significant difference favoring the longer treatment (relative hazard = 0.37; 95% CI = 0.15-0.92; P = .03). There was little difference between the tamoxifen and control groups in terms of admissions due to thromboembolic disease. CONCLUSIONS These findings suggest that long-term adjuvant treatment with tamoxifen may result in substantial reduction of cardiac morbidity in patients with low risk of death from breast cancer as well as in women in chemopreventive studies who have high risk of developing breast cancer. IMPLICATIONS Our results support continuation of ongoing trials of tamoxifen therapy in these two groups of subjects.
TL;DR: In this paper, a prospective, randomized, clinical trial comparing 20-Gy intraoperative radiotherapy in combination with postoperative low-dose (35- to 40-Gy) external-beam radiotherapy with post-operative high-dose external beam radiotherapy alone was conducted for surgically resected sarcomas.
Abstract: • Thirty-five patients with surgically resected sarcomas of the retroperitoneum were enrolled in a prospective, randomized, clinical trial comparing 20-Gy intraoperative radiotherapy in combination with postoperative low-dose (35- to 40-Gy) external-beam radiotherapy with postoperative high-dose (50- to 55-Gy) external-beam radiotherapy alone. Chemotherapy with doxorubicin hydrochloride, cyclophosphamide (anhydrous), and methotrexate sodium was used for a portion of the trial. Fifteen patients who received intraoperative radiotherapy and 20 control patients were followed up for a minimum of 5 years (median follow-up, 8 years). Median survival times were similar for the group that received intraoperative radiotherapy (45 months) and the control group (52 months). There were no indications of benefit from adjunctive chemotherapy. The number of locoregional recurrences was significantly lower among those who received intraoperative radiotherapy (six of 15) than control patients (16 of 20). Patients who received intraoperative radiotherapy had fewer complications of disabling radiation-related enteritis (two of 15) than control patients (10 of 20), but radiation-related peripheral neuropathy was more frequent among those who received intraoperative radiotherapy (nine of 15) than among control patients (one of 20). ( Arch Surg. 1993;128:402-410)
Journal Article•
TL;DR: Arginine supplementation for 2 weeks significantly enhanced wound catheter hydroxyproline accumulation and total protein content and Serum insulin-like growth factor-1 levels were significantly elevated in the arginine group.