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PubMedDate not supplied

Does a mailed continuing education program improve physician performance? Results of a randomized trial in antihypertensive care.

Evidence is sparse concerning the value of the "educational" materials that physicians receive in the mail. We conducted a randomized trial of a mailed continuing education program on hypertension for primary care physicians. Although formal pretesting documented that the program led to significant improvements in physician knowledge over the short term, the current study showed no lasting effect on physician knowledge (mean scores on an end-of-study questionnaire were 50% and 52% for study and control physicians, respectively) and no influence on performance in lowering the blood pressures of patients referred from screening (mean blood pressure drop for study patients, 12.2/10.4 mm Hg vs 13.0/10.6 mm Hg for control patients). The chance that we missed a difference in diastolic blood pressure as great as 3 mm Hg is less than 5%. Resources spent on instructional materials mailed to physicians may be wasted.

Adult↗

PubMed1985

A comparative randomized trial of vinca alkaloids in patients with metastatic breast carcinoma.

The therapeutic efficacy of vincristine, vinblastine, and vindesine were evaluated in a prospective randomized trial in patients with metastatic breast carcinoma. All patients were refractory to doxorubicin-containing chemotherapy. Vincristine was administered at 0.4 mg/m2/1/day by continuous infusion (CI), vinblastine at 1.7 mg/M2/1/day by CI, and vindesine at 1.2 mg/M2/1/day by CI or intermittent bolus (IB) over 5 days. The courses were administered at 2-week intervals for vincristine and 3-week intervals for vinblastine and vindesine. Ninety-nine patients were evaluable for response. The 15 patients treated with vincristine had no objective response. Of 23 patients treated with vinblastine, there were 2 complete responses (9%) and 5 partial responses (22%). Of 31 patients treated with CI vindesine, there were 6 partial responses (19%). Of 30 patients treated with IB vindesine, there were 5 partial responses (17%). The median duration of disease control was 13 weeks (range, 8-140+) for vinblastine, 18 weeks (range, 8-34) for CI vindesine, and 20 weeks (range, 12-47) for IB vindesine. These data illustrate that vinblastine (CI) and vindesine (CI or IB) have significant antitumor activity in patients with refractory metastatic breast carcinoma and that vincristine has not antitumor activity in similar patients.

Adult↗

PubMed1993

Double-blind placebo controlled randomized trial of indomethacin on urodynamic values measured by radionuclide imaging.

The effect of the prostaglandin synthetase inhibitor, indomethacin on urodynamic values measured by radionuclide imaging was studied in 17 men in a double-blind placebo controlled randomized trial. Measurements were made of voiding time, time for 50% emptying, average flow rate, ejection fraction, post-void residual urine volume, voided volume, and total bladder volume. Statistical analyses indicated no placebo-indomethacin differences between the two groups. Although prostaglandins are thought to contribute to the act of micturition by maintenance of bladder tone and contractility, our studies indicate that a standard dose of the prostaglandin inhibitor, indomethacin, did not affect the voiding component of bladder function. Patients need not discontinue prostaglandin inhibitors and other non-steroidal anti-inflammatory drugs with such effects prior to urodynamic testing.

Aged↗

PubMed2005

Long-term results of a prospective randomized trial comparing tacrolimus versus cyclosporine in African-American recipients of primary cadaver renal transplant.

The ideal immunosuppressive treatment for African-American kidney transplant recipients has not been established. We performed a long-term prospective randomized trial comparing the results of tacrolimus (TAC) and cyclosporine (CSA) in the African-American population. Thirty-five African-American primary cadaveric renal transplant (CRT) recipients were enrolled in the study. Group I (n = 14) received TAC and group II (n = 21) received CSA; mean follow up was 78 months. We found no difference in patient/graft survival rates between the groups. Twelve patients in the CSA group were converted to TAC, mostly because of hypercholesterolemia or as a rescue for an acute rejection episode. Significant lower creatinine and cholesterol levels were seen at 1 year post-transplant, but this difference lost significance at 3 and 5 years, possibly because of conversion of most patients from CSA to TAC. In conclusion, African-American recipients of primary CRTs can achieve excellent long-term results with TAC-based immunosuppression.

Acute Disease↗

PubMed2005

An assessment of willingness to participate in a randomized trial of arthroscopic knee surgery in patients with osteoarthritis.

Identifying barriers to recruitment into a randomized clinical trial can help researchers adjust recruitment strategies to maximize enrollment. To determine barriers to enrollment of patients in trials of knee osteoarthritis treatments, we recruited from three centers patients over age 45 who had both knee osteoarthritis and a meniscal tear. We described a hypothetical randomized trial of arthroscopic partial meniscectomy versus non-operative management and assessed patients' willingness to participate in such a trial. We elicited preferences for treatment along with information on age, sex, education level, race, work status, and pain. We examined the association between these factors and willingness to participate in the trial. Orthopedic surgeons identified 106 eligible osteoarthritis patients, of whom 12 could not be reached, 6 refused and 88 (83%) completed interviews. 63% were female, 55% were college graduates, 23% were non-white and mean age was 60+/-8. The mean WOMAC pain score was 56+/-23. 22% of patients stated that they were definitely willing to participate in the hypothetical trial, and 24% stated they were probably willing. Subjects lacking strong preferences for treatment stated a greater willingness to participate than those with strong preferences (36-14% definitely willing, chi(2) for trend, p=0.005). WOMAC pain score, age, education, work status and race were not associated with willingness to participate. Males were more likely than females to state a willingness to participate (39-11% definitely willing, p=0.005). Since OA affects females disproportionately, a better understanding of barriers to females' participation in trials may enhance future research on treatment of osteoarthritis. Effectively addressing a priori treatment preferences through patient education about the advantages and drawbacks of treatments may increase willingness to participate in trials.

Aged↗

PubMed2005

Comparison of large versus smaller randomized trials for mental health-related interventions.

OBJECTIVE: The extent of disagreement between large and smaller randomized, controlled trials on mental health issues is unknown. The authors aimed to compare the results of large versus smaller trials on mental health-related interventions. METHOD: The authors screened 161 Cochrane and 254 Database of Abstracts of Reviews of Effectiveness systematic reviews on mental health-related interventions. They identified 16 meta-analyses with at least one "large" randomized trial with sample size >800 and at least one "smaller" trial. Effect sizes were calculated separately for large and smaller trials. Heterogeneity was assessed between all studies, within each group (large and smaller studies), and between large and smaller studies. RESULTS: Significant between-study heterogeneity was seen in five meta-analyses. By random-effects calculations, the results of large and smaller trials differed beyond chance in four meta-analyses (25%). In three of these disagreements (effect of day care on IQ, discontinuation of antidepressants, risperidone versus typical antipsychotics for schizophrenia), the smaller trials showed greater effect sizes than the large trials. The inverse was seen in one case (olanzapine versus typical antipsychotics for schizophrenia). With fixed-effects models, disagreements beyond chance occurred in five cases (31%). In four meta-analyses, the effect size differed over twofold between large and smaller trials. Various quality and design parameters were identified as potential explanations for some disagreements. CONCLUSIONS: Large trials are uncommon in mental health. Their results are usually comparable with the results of smaller studies, but major disagreements do occur. Both large and smaller trials should be scrutinized as they offer a continuum of randomized evidence.

Adult↗

PubMedDate not supplied

Prospective, randomized trial of steroid withdrawal in kidney recipients treated with mycophenolate mofetil and cyclosporine.

UNLABELLED: Our transplant centre began a prospective, randomized trial of steroid withdrawal in low risk renal transplant recipients on triple immunosuppression consisting of mycophenolate mofetil (MMF), microemulsion cyclosporine (CSA), and prednisone. One hundred and twenty patients were randomized either to discontinue or remain on steroids (60 patients per group). Study design consisted of analyses of 1-yr outcomes after study entry. This report includes the 1-yr results plus results at last follow-up (mean follow-up 3.7 yr). There were no significant differences in rates of patient and graft survival at 1 yr or at last follow-up. Additionally, the incidences of acute and chronic rejection as well as graft function were the same at 1 yr and at last follow-up. Significant improvement was noted in total serum cholesterol and bone density at 1 yr and last follow-up. Initial improvement in patient weight at 1 yr was not sustained at last follow-up. No significant impact of steroid withdrawal on serum triglycerides, blood pressure, or post-transplant diabetes mellitus was observed. To date, we have observed no immunologic risk, and some significant benefit in regards to side effects, of steroid withdrawal between 6 and 36 months after transplantation in low risk renal transplant recipients maintained on prednisone, MMF, and microemulsion CSA. CONCLUSION: Steroid withdrawal in low risk kidney transplant recipients is safe and ameliorates many of the unwanted sides effects of steroid use.

Adolescent↗

PubMed1990

The effects of blinding on the quality of peer review. A randomized trial.

Peer reviewers are blinded sometimes to authors' and institutions' names, but the effects of blinding on review quality are not known. We, therefore, conducted a randomized trial of blinded peer review. Each of 127 consecutive manuscripts of original research that were submitted to the Journal of General Internal Medicine were sent to two external reviewers, one of whom was randomly selected to receive a manuscript with the authors' and institutions' names removed. Reviewers were asked, but not required, to sign their reviews. Blinding was successful for 73% of reviewers. Quality of reviews was higher for the blinded manuscripts (3.5 vs 3.1 on a 5-point scale). Forty-three percent of reviewers signed their reviews, and blinding did not affect the proportion who signed. There was no association between signing and quality. Our study shows that, in our setting, blinding improves the quality of reviews and that research on the effects of peer review is possible.

Double-Blind Method↗

PubMed1999

Percutaneous versus surgical tracheostomy: a double-blind randomized trial.

OBJECTIVE: To compare surgical (SgT) and percutaneous (PcT) tracheostomies. BACKGROUND: Percutaneous tracheostomy has been said to provide numerous advantages over classical SgT. METHODS: A prospective randomized trial with a double-blind evaluation was used to compare SgT and PcT. SgT and PcT were performed according to established techniques (n = 70). The procedure was performed at the bedside in the intensive care unit in 21 cases (30%). The outcome measures were divided into procedure-related variables, perioperative complications, and postoperative complications. The procedure-related variables (location, duration, and difficulty) were evaluated by the surgeon. The perioperative and postoperative complications were divided into serious, intermediate, and minor. Perioperative and early postoperative (14 days) complications were evaluated daily by an intensive care unit nurse blinded to the technique used. Long-term postoperative complications were evaluated 3 months after decannulation by a surgeon blinded to the surgical technique. RESULTS: There were no major complications in either group. Most variables studied were not statistically different between the PcT and SgT groups. The only variables to reach statistical significance were the size of the incision (smaller with PcT, p < 0.0001), minor perioperative complications (greater with PcT, p = 0.02), and difficult cannula changes (greater with PcT; p < 0.05). Among nonsignificant differences, difficult procedures and false passages were more frequent with PcT, whereas long-term unesthetic scars were more frequent with SgT. CONCLUSIONS: Both techniques are associated with a low rate of serious or intermediate complications when performed by experienced surgeons. There were more minor perioperative complications with PcT and more minor long term complications with SgT.

Double-Blind Method↗

PubMed1983

Metastatic colorectal carcinoma. A prospective randomized trial of Methyl-CCNU, 5-Fluorouracil (5-FU) and vincristine (MOF) versus MOF plus streptozotocin (MOF-Strep).

A prospective randomized trial evaluated semustine (Methyl CCNU) 5-Fluorouracil (5-FU) and vincristine (MOF) versus MOF plus streptozotocin (MOF-Strep) in 75 patients with advanced, measurable colorectal carcinoma. The complete and partial remission rate with MOF-Strep was significantly better, 34 versus 5% with MOF (P = 0.003). Gastrointestinal toxicity was increased with the addition of streptozotocin. Initial patient characteristics such as age, sex, performance status, time from diagnosis to metastatic disease, site of metastatic disease, and most initial laboratory values were not predictive of response. However, certain initial laboratory values (lactic dehydrogenace and leukocyte count) and one tumor site pulmonary metastases did influence survival regardless of response.

Adult↗

PubMed2001

Distribution of the probability of survival is a strategic issue for randomized trials in critically ill patients.

BACKGROUND: Many randomized clinical trials in trauma have failed to demonstrate a significant improvement in survival rate. Using a trauma patient database, we simulated what could happen in a trial designed to improve survival rate in this setting. METHODS: The predicted probability of survival was assessed using the TRISS methodology in 350 severely injured trauma patients. Using this probability of survival, the authors simulated the effects of a drug that may increase the probability of survival by 10-50% and calculated the number of patients to be included in a triad, assuming alpha = 0.05 and beta = 0.10 by using the percentage of survivors or the individual probability of survival. Other distributions (Gaussian, J shape, uniform) of the probability of survival were also simulated and tested. RESULTS: The distribution of the probability of survival was bimodal with two peaks (< 0.10 and > 0.90). There were major discrepancies between the number of patients to be included when considering the percentage of survivors or the individual value of the probability of survival: 63,202 versus 2,848 if the drug increases the probability of survival by 20%. This discrepancy also occurred in other types of distribution (uniform, J shape) but to a lesser degree, whereas it was very limited in a Gaussian distribution. CONCLUSIONS: The bimodal distribution of the probability of survival in trauma patients has major consequences on hypothesis testing, leading to overestimation of the power. This statistical pitfall may also occur in other critically ill patients.

Adolescent↗

PubMed1999

Prospective, double-blind, placebo-controlled randomized trial of cimetidine in gastric cancer. British Stomach Cancer Group.

Cimetidine is thought to inhibit suppressor T-lymphocyte function and preliminary evidence from a randomized trial indicated that it might prolong survival for patients with operable and inoperable gastric cancer. The British Stomach Cancer Group conducted a randomized, double-blind, placebo-controlled trial examining the effects of cimetidine (400 mg or 800 mg twice a day) on the survival of patients with early (stages I, II and III: n = 229) and advanced (stages IVa and IVb: n = 201) gastric cancer. The primary end point was death. A total of 442 patients were randomized by 59 consultants in 39 hospitals between February 1990 and March 1995. Log-rank survival analysis was used to assess differences between the groups. Three hundred and forty patients died during the study: 166 (49%) in the cimetidine treatment groups and 174 (51%) in the placebo groups. Median survival for patients receiving cimetidine was 13 months (95% confidence interval (CI) 9-16 months) and 11 months in the placebo arm (95% CI 9-14 months). There was no significant difference in survival between the two treatment groups (P = 0.42) or between different doses of cimetidine tablets (P = 0.46). Five-year survival of those patients randomized to cimetidine was 21% compared to 18% for those patients randomized to placebo. Cimetidine at a dose of 400 mg or 800 mg twice a day does not have a significant influence on the survival of patients with gastric cancer compared to placebo.

Adult↗

PubMed2003

Randomized Trial of Telephone Intervention in Chronic Heart Failure (DIAL): study design and preliminary observations.

BACKGROUND: In the last few years different approaches based on comprehensive patient care and close surveillance by multidisciplinary teams have shown promising results in heart failure. However, current evidence mainly derives from small and often nonrandomized studies performed at a single center, with selected populations, using dissimilar and complex strategies. We designed a large randomized study to test the hypothesis that a single program, based on a centralized telephone intervention performed by trained nurses, could reduce morbidity and mortality in chronic heart failure. METHODS: The Randomized Trial of Telephone Intervention in Chronic Heart Failure (DIAL) is a randomized, controlled, open trial designed to compare frequent telephone follow-up intervention versus control. We enrolled 1518 patients with stable chronic heart failure and optimal treatment from 51 centers in Argentina. DIAL trial intervention strategy is based on frequent telephone follow-up provided by nurses trained in heart failure and performed from a single surveillance center, assuring a homogeneous and high quality intervention. The primary objective is to determine the effect of the intervention as compared with the usual follow-up on the combined endpoint of all-cause mortality or hospitalization for worsening heart failure. The objectives of the intervention are education, counseling, and monitoring to enhance self-control mechanisms, timely medical visits, diet, and drug therapy compliance. Telephone call frequency was determined according to preestablished criteria of clinical status severity assessed at each phone contact. The study ended in August 2002. CONCLUSION: The results of this study may provide information about mortality, hospitalizations, and quality of life contributing to set standards for management programs in the current treatment of chronic heart failure.

Female↗

PubMed2006

Health-related quality of life and self-reported ability concerning ADL and IADL after hip fracture: a randomized trial.

BACKGROUND: It is not known whether postoperative occupational therapy is of value for hip fracture patients. In this randomized trial we evaluated the effects of an individualized, postoperative, occupational training (OT) program on the patient's self-reported health-related quality of life (HRQL) and self-reported abilities to perform activities of daily living (ADL) and instrumental activities of daily living (IADL). PATIENTS AND METHODS: 100 eligible patients (aged >or= 65 years) were randomized 50:50 to an OT or control group (termed the C group: conventional care). The OT group received individualized OT from day 3 or 4 after surgery and until discharge, and also a home visit. The patients answered the Swedish Health-Related Quality of Life questionnaire (SWED-QUAL) and the modified Disability Rating Index (DRI) three times: 3-4 days after surgery, at discharge, and at follow-up after 2 months. RESULTS: We found no statistically significant differences between the groups at discharge and at follow-up regarding mean SWED-QUAL scores. However, on comparing each group over time, 2 months after the fracture the OT group had regained their self-reported pre-fracture HRQL status in 10 of 12 SWED-QUAL subscales, and the C group in 6 subscales. Statistically significant differences (p < 0.05) were found between the groups after 2 months regarding self-reported IADL (moving around indoors, performance of light housework, and getting in and out of a car). INTERPRETATION: Our findings indicate that the individualized occupational training improved the ability to perform IADL and appeared to speed up the recovery in some HRQL areas.

Activities of Daily Living↗

PubMed2003

Prevention of immediate reinitiation of atrial tachyarrhythmias by high-rate overdrive pacing: results from a prospective randomized trial.

INTRODUCTION: Immediate reinitiation of atrial tachyarrhythmia (IRAT) is an important cause of failure to maintain sinus rhythm. IRAT prevention by overdrive pacing has not been evaluated in a prospective randomized trial. METHODS AND RESULTS: Patients with a DDDRP pacemaker offering temporary atrial overdrive pacing after AT termination (Post Mode Switching Overdrive Pacing [PMOP]) were enrolled into the prospective PIRAT (Prevention of IRAT) trial if paroxysmal AT episodes occurred after implantation. PMOP was randomly activated (120 beats/min for 2 min) or inactive. After 3 months, device memory was interrogated, symptoms and quality of life assessed, and patients crossed over to the alternative treatment arm for another 3 months. Primary study endpoint was the number of AT episodes; secondary endpoints were the cumulative time in AT (AT burden), percentage of AT episodes with IRAT, symptoms, and quality of life with PMOP active versus inactive. In 37 patients (21 men; 69 +/- 9 years), there was no difference in the median number of AT episodes (0.37 vs 0.34 per day), AT burden (both 1%), percentage of episodes with IRAT (30%vs 28%), symptoms, and quality of life during PMOP off versus on. With PMOP active, 29% of 439 ATs restarted during and 18% before PMOP intervention. The PMOP-induced rate increase appeared to be associated with IRAT in 9% of AT episodes. CONCLUSION: Automatic overdrive pacing after AT termination did not prevent IRAT, mainly due to insufficient overdrive suppression even at 120 beats/min and the delay between AT termination and PMOP intervention.

Aged↗

PubMed2006

Active for Life After Cancer: a randomized trial examining a lifestyle physical activity program for prostate cancer patients.

BACKGROUND: Active for Life After Cancer is a randomized trial evaluating the efficacy of a 6-month group-based lifestyle physical activity program (Lifestyle) for prostate cancer patients to improve quality of life (QOL) including physical and emotional functioning compared to a group-based Educational Support Program and a Standard Care Program (no group). METHOD: A total of 134 prostate cancer patients receiving continuous androgen-ablation were randomly assigned to one of the three study conditions. RESULTS: Results indicated no significant improvements in QOL at 6 or 12 months. Both group-based programs were positively received and yielded good attendance and retention. Lifestyle participants demonstrated significant improvements in most theoretical mediators proposed by the Transtheoretical Model and Social Cognitive Theory to affect physical activity. Despite these improvements, no significant changes were found for most physical activity measures. CONCLUSIONS: Results suggest a lifestyle program focusing on cognitive-behavioral skills training alone is insufficient for promoting routine physical activity in these patients.

Adaptation, Psychological↗

PubMed2003

[Evaluation of stent-protected angioplasty for theray of symptomatic stenoses of the carotid artery. SPACE and other randomized trials].

During recent years, stent-protected angioplasty of the carotid artery (SPAC) has become an alternative to endartectomy (CEA) in many centers. Despite many case reports, case series, and open records, it has not been proven that these therapeutical regimens are comparable regarding complication rates and long-term outcome. Until now, only three randomized trials were published on this theme, two of them only as abstracts. This is not sufficient for answering the question of whether SPAC is a good alternative to CEA. At present, four major, randomized, multicenter trials are being run (EVA3S in France, CREST in the US, ICSS in Great Britain and several other countries, and SPACE in Germany and Austria). About 7,300 patients will be included in these trials. At present, 24 centers are participating in the SPACE trial, recruiting about 350 patients. It has been prospectively agreed that EVA-3S, ICSS, and SPACE will combine their results after completion of initial randomization and follow-up to conduct a combined European meta-analysis of the data. Three to 5 years are needed until these trials' final results will be published. Until then, stent-protected angioplasty should be done only under the consideration that it has not been scientifically evaluated.

Angioplasty, Balloon↗

PubMed2002

Cisplatin-based therapy for elderly patients with advanced non-small-cell lung cancer: implications of Eastern Cooperative Oncology Group 5592, a randomized trial.

BACKGROUND: Older patients, even if fit, are often considered incapable of tolerating platinum-based systemic therapy. We performed a retrospective analysis of Eastern Cooperative Oncology Group (ECOG) 5592, a phase III randomized trial of platinum-based chemotherapy regimens for non-small-cell lung cancer (NSCLC), and compared outcomes in enrollees 70 years of age and older with those in younger patients. METHODS: ECOG carried out a randomized phase III trial of cisplatin plus either etoposide or paclitaxel in chemotherapy-naïve NSCLC patients with stages III(B) or IV disease. Toxic effects, response rates, and survival rates were compared between age groups. All P values were two-sided. RESULTS: A total of 574 patients enrolled from August 1993 through December 1994 were evaluable. Eighty-six (15%) were 70 years old or older. Older patients had a higher incidence of cardiovascular (P =.009) and respiratory (P =.04) comorbidities and nonanalgesic medication use (P =.02). Leukopenia (P<.001) and neuropsychiatric toxicity (P =.002) were more common in elderly men than in younger men. Elderly women lost more weight than younger women (P =.006). Other toxic effects were similar in older and younger patients. The proportions with clinical partial or complete response (21.5% versus 23.3%; Fisher's exact test, P =.66), median time to progression (4.37 versus 4.30 months; log-rank test, P =.29), and survival distribution (log-rank test, P =.29; median survival, 9.05 versus 8.53 months; 1-year survival, 38% versus 29%; and 2-year survival, 14% versus 12%) were similar in patients younger than 70 years and 70 years old or older. Baseline quality-of-life and treatment-outcome indices were similar. Equivalent declines over time in functional well-being occurred in both groups. CONCLUSION: Response rate, toxicity, and survival in fit, elderly NSCLC patients receiving platinum-based treatment appear to be similar to those in younger patients, although patients 70 years old or older have more comorbidities and can expect more leukopenia and neuropsychiatric toxicity. Advanced age alone should not preclude appropriate NSCLC treatment.

Aged↗