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Results for “Randomized trial”

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At least 253 records · Page 14Linked to original sources

PubMed2001

Cefepime versus cefotaxime for empirical treatment of bacterial pneumonia in HIV-infected patients: an open, randomized trial.

An open, randomized, multicentre clinical trial was conducted to compare the efficacy and safety of cefepime 2 g iv bd (2 g tds daily in cases of Pseudomonas aeruginosa pneumonia) with cefotaxime 2 g iv tds, in the empirical treatment of bacterial pneumonia in HIV-infected patients. The primary end-point was effectiveness after 3-5 days of treatment, taking success to be when the study drug was continued during this period of time. Clinical and bacteriological responses at end of treatment (EOT) were also evaluated. Analyses of the intention-to-treat population (n = 160) and the as-per-protocol groups (n = 150) were carried out. Treatment groups were comparable with regard to sex, age, HIV status and degree of severity of pneumonia. The primary end-point for cefepime was considered successful for the intention-to-treat and as-per-protocol groups in 85.7% and 93.5% of cases, respectively, and for cefotaxime, in 77.6% and 80.8% of cases, respectively (P = 0.22 and P = 0.02). In the as-per-protocol group, cefotaxime treatment was independently related to failure at the primary end-point. A satisfactory clinical response in the intention-to-treat population was observed in 83.3% of cefepime and 82.9% of cefotaxime patients. Bacteriological cure was obtained in 100% of evaluable cefepime and 93.4% of evaluable cefotaxime patients at EOT. Safety of the study drugs was comparable in both treatment groups. Cefepime 2 g iv bd was at least as effective and as well tolerated as cefotaxime 2 g iv tds in the treatment of bacterial pneumonia in HIV-infected patients.

Adult↗

PubMed1996

Anterior cervical discectomy with or without fusion with acrylate. A randomized trial.

STUDY DESIGN: A prospective randomized trial with assessment of treatment results by an independent observer and by patient questionnaire. OBJECTIVES: This study evaluated whether implantation of polymethylmethacrylate after anterior cervical discectomy improved clinical results and whether polymethylmethacrylate provided a solid bony union with preservation of anatomical relations of the cervical spine. SUMMARY OF BACKGROUND DATA: Discectomy without fusion disturbs anatomical relations of the cervical spine. Use of an autologous bone graft frequently causes donor-site complications. Therefore, synthetic materials such as polymethylmethacrylate have been used instead of bone to obtain spinal fusion. Whether these implants improve the clinical results of anterior discectomy is unknown. In addition, the radiological follow-up of discectomy with polymethylmethacrylate has hardly been investigated. METHODS: Between April, 1986, and April, 1990, all patients with radiologically proven cervical disc pathology and a radicular syndrome were eligible for this study. The primary endpoint of the study was the clinical result after 2 years. Assessment of the result was rated both by an independent observer using Odom's criteria and by the patient using a written questionnaire. Before surgery and during follow-up, radiographs were obtained. RESULTS: Two patients died during follow up. A good result was obtained in 28 of 42 patients (70%) treated with polymethylmethacrylate and in 30 of 39 patients (77%) of patients treated with discectomy only. Pre-operative neck pain subsided earlier if polymethylmethacrylate was used, but the difference was temporary and clinically insignificant. The use of polymethylmethacrylate resulted in a significant lower bony union rate. Polymethylmethacrylate frequently migrated into adjacent vertebrae. CONCLUSIONS: No relevant clinical differences between treatments were found. The radiological results of anterior discectomy with polymethylmethacrylate were inferior to those of discectomy only. Based on these results, the use of polymethylmethacrylate to obtain fusion after anterior discectomy is not recommended.

Acrylates↗

PubMed2001

Type-II error rates (beta errors) of randomized trials in orthopaedic trauma.

BACKGROUND: Although an investigator may limit bias through randomization, concealment of patient allocation, and blinding, the results of randomized trials may be less convincing when the sample size is not sufficiently large to reveal a true difference between treatment groups. When the sample size is small, randomized trials are subject to beta errors (type-II errors)--that is, the probability of concluding that no difference between treatment groups exists when, in fact, there is a difference. The purpose of this study of randomized trials involving fracture care published between 1968 and 1999 was twofold: (1) to evaluate type-II error rates and study power (1 - beta) for the primary outcomes and (2) to identify whether investigators clearly identified the primary and secondary outcomes. METHODS: To be eligible, studies were required to (1) be published in English, (2) be described as a randomized trial, (3) involve the care of adult patients with fractures, treated either operatively or nonoperatively, and (4) contain sufficient outcome information to enable study power to be calculated. Computer database searches were performed independently by two investigators to identify all potentially relevant study titles. Additional strategies to identify articles included (1) hand searches of selected orthopaedic journals from 1989 to 1999, (2) searches of the bibliographies of potentially relevant articles, and (3) review by content experts to identify missing studies. For each study, a standard power calculation was performed on the primary and secondary outcomes. For those studies in which the primary outcome was not explicitly reported, the most clinically relevant measure was chosen by consensus. Acceptable study power was agreed a priori to be > or = 80% (type-I error of < or = 0.20). RESULTS: We identified 620 potentially relevant citations from MEDLINE, of which only 187 were potentially eligible. We identified nine more articles with other searches, and application of the eligibility criteria to the 196 articles eliminated seventy-nine. Thus, we analyzed 117 studies in which a total of 19,942 patients with orthopaedic trauma had been randomized. Sample sizes ranged from ten to 662 patients (mean and standard deviation, 95 79 patients). The majority (34%) of trials involved the treatment of hip fractures. The mean overall study power among the 117 trials was 24.65% (range, 2% to 99%). The type-II error rate for primary outcomes was 90.52%. CONCLUSIONS: Mean type-II error rates in the orthopaedic trauma trials that we analyzed exceeded accepted standards. Investigators can reduce type-II error rates by performing power and sample-size calculations prior to conducting a trial.

Fractures, Bone↗

PubMed2004

Conventional vs endobronchial ultrasound-guided transbronchial needle aspiration: a randomized trial.

STUDY OBJECTIVE: Our group performed a randomized trial to assess whether the addition of endobronchial ultrasound (EBUS) guidance will lead to better results than standard transbronchial needle aspiration (TBNS). EBUS guidance seems to be beneficial in increasing the yield of TBNA but has not been proven to be superior to conventional procedures in a randomized trial. METHODS: Consecutive patients who were referred for TBNA were randomized to an EBUS-guided and a conventional TBNA arm. Patients with subcarinal lymph nodes were randomized and analyzed separately (group A) from all other stations (group B). A positive result was defined as either lymphocytes or a specific abnormality on cytology. RESULTS: Two hundred patients were examined (100 patients each in groups A and B). Half of the patients underwent EBUS-guided TBNA rather than conventional TBNA. In group A, the yield of conventional TBNA was 74% compared to 86% in the EBUS group (difference not significant). In group B, the overall yields were 58% and 84%, respectively. This difference was statistically highly significant (p < 0.001). The average number of passes was four. CONCLUSION: EBUS guidance significantly increases the yield of TBNA in all stations except in the subcarinal region. It should be considered to be a routine adjunct to TBNA. On-site cytology may be unnecessary, and the number of necessary needle passes required is low.

Biopsy, Needle↗

PubMedDate not supplied

Endoscopic sclerosis and esophageal balloon tamponade in acute hemorrhage from esophagogastric varices: a prospective controlled randomized trial.

A prospective randomized controlled clinical trial was performed in 43 consecutive histologically proved cirrhotic patients with endoscopically proved actively bleeding esophageal varices. Twenty-two were randomly selected to have esophageal tamponade with the Sengstaken-Blakemore tube, and 21 were selected to have endoscopic sclerosis of the esophageal wall. The two groups were similar in demographic, clinical and laboratory data. Bleeding was controlled by the Sengstaken-Blakemore tube in 16 of 22 patients (73%) and by endoscopic sclerosis in 20 of 21 (95%). Among those controlled by the Sengstaken-Blakemore tube, seven (44%) rebled and three (43%) were again controlled by the Sengstaken-Blakemore tube; in the endoscopic sclerosis group, four (20%) rebled and three (75%) were controlled. Thus, hemorrhage was definitively controlled in 52% of patients and 66% of bleeding episodes in the Sengstaken-Blakemore tube group and in 90% of patients and 92% of bleeding episodes in the endoscopic sclerosis group. The definite control of hemorrhage was significantly better in the endoscopic sclerosis group (p less than 0.01). The Sengstaken-Blakemore tube patients received no definitive therapy after bleeding had been controlled. Within 30 days, six patients (27%) in the Sengstaken-Blakemore tube group had died compared to 2 (10%) in the endoscopic sclerosis group which is statistically significant (p less than 0.01) in favor of endoscopic sclerosis. The frequency of complications was similar in the two groups. Endoscopic sclerosis patients received serial endoscopic sclerosis after bleeding had been stopped during the whole period of follow-up.(ABSTRACT TRUNCATED AT 250 WORDS)

Clinical Trials as Topic↗

PubMed2006

Paediatric home care: a systematic review of randomized trials on costs and effectiveness.

OBJECTIVE: To review systematically randomized trials (RCTs) on the effectiveness and costs of paediatric home care. METHODS: National Health Service (NHS) Centre for Reviews and Dissemination guidelines were followed. In all, 20 electronic and other sources were searched, using specially designed strategies. Economic studies and other selected designs were included, but only RCT findings--on service use, clinical outcomes, costs, and impact on the family--are reported here. Analysis is descriptive, with pooled standard mean differences used where meta-analysis was possible. RESULTS: About 1730 identified records up to August 2001 were potentially relevant. In all, 10 RCTs (24 papers) were finally included, covering five types of paediatric home care--for very low birth weight or medically 'fragile' infants, for asthma or diabetes, for technology-dependent children, for mental health, and generic home care. Paediatric home care may enhance physical and mental development for very low birth weight infants and may be cheaper but the evidence is not strong. Home care for diabetes or asthma may reduce parents' costs with some clinical but no social differences noticeable. No randomized trials for technologically dependent children were found. Home care for mental health may increase parental satisfaction with services and reduce some health service and residential care costs. Generic home care showed no clinical effects at early follow-up. Partial follow-up after five years suggested improved psychological adjustment. No cost data were available for this care model. CONCLUSIONS: Despite recent expansion, research evidence from randomized trials for paediatric home care is slight, and methods used are weak in places. Paediatric home care poses practical and ethical questions that cannot be addressed by RCTs.

Costs and Cost Analysis↗

PubMed2004

A systematic review of randomized trials in localized prostate cancer.

INTRODUCTION: Most treatment studies of localized prostate cancer are observational in nature. The recent publication of a large randomized trial of radical prostatectomy (RP) versus watchful waiting (WW) has focused increased attention on the treatment of localized prostate cancer. We reviewed all published randomized trials that compared different primary treatment modalities for localized prostate cancer. MATERIALS AND METHODS: We performed a comprehensive Medline search from 1966 to March 2003 to identify all English-language randomized trials of RP, external-beam radiotherapy (EBRT), brachytherapy, watchful waiting, and primary androgen-deprivation therapy in localized prostate cancer. RESULTS: Nine publications dealing with four separate randomized trials were identified. Two studies examined RP and WW; one study examined RP and EBRT; one study examined RP and EBRT, with both groups receiving neoadjuvant and adjuvant androgen-deprivation therapy. WW, in both studies, refers to no treatment until palliative therapy is required. Two of the four trials, conducted in Veterans Administration medical centers, had small sample sizes and were plagued by several methodological limitations. Neither trial was able to convincingly demonstrate an advantage of RP over WW or RP over EBRT. One trial of RP versus EBRT included patients with both localized and locally advanced disease. The fourth trial demonstrated statistically significant reduction in disease-specific mortality, local progression, and development of metastases in patients with primarily clinically detected, well- or moderately well differentiated prostate cancer who underwent RP as compared to WW. CONCLUSIONS: There is high-quality evidence from one randomized trial in favor of surgery over watchful waiting with palliative intent for non-high grade localized prostate cancer. However, most tumors in this study were clinically diagnosed rather than screen-detected. Further randomized trials examining the treatment of screen-detected, localized prostate cancer are needed; several are currently underway.

Adult↗

PubMed2006

N-acetylcysteine and contrast-induced nephropathy: a meta-analysis of 13 randomized trials.

BACKGROUND: Contrast-induced nephropathy (CIN) following coronary angiography increases morbidity and mortality. Randomized trials of small sample size have evaluated whether N-acetylcysteine (NAC) prevents CIN in patients with renal dysfunction. METHODS: To conduct a meta-analysis of the randomized trials the following databases were searched: MEDLINE (1966-2003), Cochrane Controlled Trials Register, ACP Journal Club online, published abstracts presented at the major cardiology and nephrology meetings, references from reviews. Two authors independently evaluated all relevant randomized trials. Eligibility criteria were (1) randomized placebo controlled trials of NAC, (2) patients with impaired renal function (creatinine >1.2 mg/dL) undergoing coronary angiography, (3) patients receiving intravenous fluids and low-osmolarity nonionic contrast media, (4) the primary outcome was CIN (increases in creatinine of either at least 0.5 mg/dL or 25% from baseline to 48 hours). Of 589 trials reviewed 3 disagreements were easily resolved by mutual discussion and 13 were selected. Data extraction included patient characteristics, intravenous fluid regimen, type and dose of contrast media, dosing regimen, creatinine at baseline and 48 hours and CIN requiring dialysis. RESULTS: Four of the 13 trials reported statistically significant results. In meta-analysis of the 13 trials, which included 1892 patients, the RR was 0.68 (95%CI, 0.46-1.01). The addition of the trial of patients undergoing computerized tomography, which had formulated the hypothesis, yielded a statistically significant reduction (RR 0.64 [95%CI 0.42-0.96]) as did an earlier meta-analysis of 7 trials. CONCLUSIONS: Our meta-analysis of the most currently available randomized data concerning NAC before coronary angiography to prevent CIN in patients with impaired renal function is neither conclusive nor provides proof beyond a reasonable doubt to influence clinical practice and public policy. The intervention has minimal toxicity but the width of the 95% CI remains compatible with a range from a large benefit to none at all. In addition, the trials used change in creatinine as the measure of outcome. Further randomized trials of large sample size and with clinical outcomes will add importantly relevant information to the totality of evidence and allow the most rational clinical decisions for individual patients as well as policy decisions for the health of the general public.

Acetylcysteine↗

PubMed1991

Use of leukocyte-depleted platelet concentrates for the prevention of refractoriness and primary HLA alloimmunization: a prospective, randomized trial.

Compared with conventional transfusion regimes a strong reduction in HLA alloimmunization and refractoriness to platelet transfusions is obtained when both red blood cell concentrates (RBCs) and platelet concentrates (PCs) are depleted of leukocytes by filtration. Because most of the leukocyte contamination is introduced by transfusion of RBCs, filtration of RBCs appears rational, but uncertainty exists regarding the degree of leukocyte-depletion of PCs needed for the prevention of HLA alloimmunization and refractoriness. We conducted a prospective trial and randomized patients with acute leukemia to receive leukocyte-depleted PCs prepared either by centrifugation (mean leukocyte count 35 x 10(6)/PC of 6 U) or by filtration (mean leukocyte count less than 5 x 10(6)/PC of 6 U). Both groups received RBCs that were filtered after prior removal of the buffy coat. Clinical refractoriness occurred in 46% (12 of 26) of the evaluable patients that were transfused with centrifuged PCs and only in 11% (3 of 27) in the filtered group (P less than .005). De novo anti-HLA antibodies were detected in 42% (11 of 26) patients in the centrifuged group and only in 7% (2 of 27) of the patients receiving filtered PCs (P less than .004). In 8 of 11 alloimmunized patients in the centrifuged group antibodies were detected in the first 4 weeks of transfusion therapy while none of the patients in the filtered group became immunized against HLA antigens during that period. We conclude that for the prevention of HLA alloimmunization and refractoriness to platelet transfusions from random donors, both RBCs and PCs have to be leukocyte-depleted by filtration.

Acute Disease↗

PubMed1985

Randomized trials of coronary artery bypass surgery: impact on clinical practice at Duke University Medical Center.

Trends in practice patterns at Duke University Medical Center were assessed in patient groups comparable to those enrolled in the three major randomized trials of coronary artery bypass grafting (CABG). In addition, changes in practice patterns that appeared unrelated to the randomized trials were examined. Most patients with 75% or greater left main stenosis have been treated surgically after publication of the Veterans Administration Cooperative Study, but little change was noted in the proportion of patients with 50% left main stenosis who have been treated surgically. A trend towards selection of surgical therapy for patients with three-vessel disease and normal left ventricular function was evident before the publication of the European Coronary Surgery Study, although one-third of patients in this category continue to be treated nonsurgically after publication of the results of the trial. For the past decade, most patients who would have been eligible for the Coronary Artery Surgery Study have been treated nonsurgically. We have also documented trends in practice patterns that are independent of the results of randomized trials. The advent of percutaneous transluminal angioplasty has provided another therapeutic alternative that has been used increasingly. In addition, growing numbers of patients with advanced age, unstable angina, or markedly depressed left ventricular ejection fraction are being evaluated with cardiac catheterization despite the lack of supporting randomized trials. Randomized trials have placed our understanding of the effects of CABG on a sound foundation, but it is evident that clinicians continue to consider many other factors when therapeutic decisions are made.

Academic Medical Centers↗

PubMed2006

Impact of on-site initiation visits on patient recruitment and data quality in a randomized trial of adjuvant chemotherapy for breast cancer.

PURPOSE: To provide empirical evidence on the impact of on-site initiation visits on the following outcomes: patient recruitment, quantity and quality of data submitted to the trial coordinating office, and patients' follow-up time. PATIENTS AND METHODS: This methodological study was performed as part of a randomized trial comparing two combination chemotherapies for adjuvant treatment of breast cancer. Centers participating to the trial were randomized to either receive systematic on-site visits (Visited group), or not (Non-visited group). RESULTS: The study was terminated after two years, while the main randomized trial continued. Of the 135 centers that had expressed an interest in the trial, only 69 randomized at least one patient (35/68 in the Visited group, 34/67 in the Non-visited group). Almost two-thirds of the patients were entered by 17 centers (10 in the Visited group, seven in the Non-visited group) that accrued more than 10 patients each. None of the prespecified outcomes favored the group of centers submitted to on-site initiation visits (ie, mean number of queries par patient: 6.1 +/- 9.7 versus 5.4 +/- 6.4, respectively for the Visited and Non-visited groups). Spontaneous transmittal of case report forms, although required by protocol, was low in both randomized groups (mean number of pages per patient: 1.5 +/- 2.0 versus 2.1 +/- 2.3, respectively), with investigators submitting about one-third of the expected forms on time (29% and 39%, respectively). LIMITATIONS: This study could not evaluate the impact of repeated on-site visits on clinical outcomes. CONCLUSION: Systematic on-site initiation visits did not contribute significantly to this clinical trial.

Antineoplastic Agents, Phytogenic↗

PubMed2002

Intraclass correlation coefficients for cluster randomized trials in primary care: data from the MRC Trial of the Assessment and Management of Older People in the Community.

The cluster randomized trial, in which groups rather than individuals are allocated to different interventions, is an increasingly popular design. In cluster trials observations on individuals within the same cluster may be correlated, and this lack of independence must be taken into account when designing a new trial. We present intraclass correlation coefficients derived from the Medical Research Council Trial of the Assessment and Management of Older People in the Community. This is a UK-based randomized trial comparing different methods of multidimensional screening for people aged 75 years and over. One hundred six general practices and over 30,000 individuals are taking part. Estimates of the intraclass correlation coefficients were obtained using one-way analysis of variance. This is by far the broadest collection of intraclass correlation coefficients for older people at the level of the primary care clinic published to date. The intraclass correlation coefficients presented will be useful in calculating sample sizes for cluster randomized trials and surveys at the primary care clinic level. In conjunction with other papers presenting collections of intraclass correlation coefficients, this paper should help to improve the quality of cluster randomized trials and hence help lead to more reliable estimates of the effectiveness of health care interventions.

Activities of Daily Living↗

PubMed2000

Laparoscopic hernioplasty versus conventional hernioplasty (Shouldice): results of a prospective randomized trial.

The results of our randomized trial of 176 patients comprising primary hernias [Shouldice versus transabdominal preperitoneal approach (TAPP)] showed only slight advantages for the laparoscopically operated group compared to the conventionally operated group: less subjective pain (significant only on fifth postoperative day, p < 0.05), reduced analgesic requirement (significant only on third postoperative day, p < 0.05), significantly shorter duration of hospitalization (4 days vs. 6 days, p < 0.05) and faster return to work (27 days vs. 34 days, NS). Regarding the incidence of recurrences, there was no significant difference between the groups (two recurrences vs. one recurrence) within a follow-up period of 2 years. Postoperative morbidity was similar and the total cost was less for the TAPP group.

Female↗

PubMed2003

Evidence for efficacy without increased toxicity of hypofractionated radiotherapy for prostate carcinoma: early results of a Phase III randomized trial.

PURPOSE: We performed a randomized trial to compare the GI and urogenital toxicity of radiotherapy (RT) for localized (confined to the organ), early-stage (T1-T2N0M0, TNM classification) carcinoma of the prostate, using a conventional (64 Gy in 32 fractions within 6.5 weeks) vs. a hypofractionated (55 Gy in 20 fractions within 4 weeks) schedule and to determine the efficacy of the respective treatment schedules. METHODS AND MATERIALS: This report is based on an interim analysis of the first 120 consecutive patients in this Phase III trial after a median follow-up of 43.5 months (range 23-62). RT planning was based on two-dimensional CT data, and the treatment was delivered using a three- or four-field 6-23-MV photon technique. GI and urogenital toxicity (symptom questionnaires incorporating the subjective elements of the late effects of normal tissues-subjective, objective, management, analytic classification of late effects and the European Organization for Research and Treatment of Cancer sexual function questionnaire) were evaluated before RT and 1 month, 1 year, and 2 years after RT completion. The efficacy of RT was assessed clinically (digital rectal examination and radiologic imaging) and biochemically (prostate-specific antigen assay) at baseline, and every 3 months for 2 years after RT and every 6 months subsequently. RESULTS: RT, whether conventional or hypofractionated, resulted in an increase in all six symptom categories used to characterize GI toxicity and in four of five symptom categories used to document urinary morbidity 1 month after therapy completion. Sexual dysfunction (based on limited data), which existed in more than one-third of patients before RT, also increased to just more than one-half of patients 1 month after RT. The increase in urinary toxicity after RT was not sustained (diurnal urinary frequency had decreased significantly at 2 years). In contrast, all six symptom categories of GI toxicity remained increased 1 year after RT. Four of the six GI symptom categories (rectal pain, mucous discharge, urgency of defecation, and rectal bleeding) were still increased at 2 years compared with baseline. Except for a slightly greater percentage of patients experiencing mild rectal bleeding at 2 years among those who received hypofractionated RT, no differences were noted in toxicity between the conventional and hypofractionated RT schedule. The mean prostate-specific antigen level was 14.0 +/- 1.0 ng/mL at baseline and declined to a nadir of 1.3 +/- 0.2 ng/mL at a median of 16.8 months (range 0.8-28.3) after RT completion. However, it then rose in 17 patients (8 in the hypofractionated and 9 in the conventional treatment group). Only 8 of these 17 patients were found to have signs of clinical relapse (5 local, 1 regional lymph node, and 2 systemic [bony metastases]) after histopathologic and radiologic reassessment). The remaining 9 patients had biochemical relapse only (defined as three consecutive rises in prostate-specific antigen after nadir). The 4-year biochemical relapse-free survival rate was 85.8% for all patients and did not differ significantly between the two radiation dose schedules (86.2% for the hypofractionated and 85.5% for the conventional fractionation group). CONCLUSION: RT for prostate carcinoma, using a three- or four-field 6-23-MV photon technique without posterior shielding of the lateral fields, is an underestimated cause of persistent GI morbidity. The incidence of clinically significant GI and urogenital toxicity after conventional and hypofractionated RT appears to be similar. Hypofractionated RT for carcinoma of the prostate seems just as effective as conventional RT after a median follow-up approaching 4 years.

Adult↗

PubMedDate not supplied

Digital radiography in pediatric orthopaedics: a prospective, controlled, and randomized trial.

A prospective, controlled, and randomized trial of digital radiography was conducted to evaluate its advantages in children. Matched pairs of radiographs of the feet were taken in 20 children, and pelvic radiographs were taken in another 20 children. Each pair comprised a digital and conventional film. Half of the digital films were made with a 50% radiation dose reduction. The films were scored for quality. Statistically significant advantages were seen for the digital radiographs as compared with the conventional technique. Visualization of soft tissue and bony detail was enhanced in both foot and pelvic radiographs. This was true even with a 50% dose reduction in many of the parameters scored. We conclude that digital radiography offers advantages over conventional radiography, and recommend its use.

Child↗

PubMed1988

The effectiveness of a worksite self-help smoking cessation program: a randomized trial.

A 2 x 2 randomized, factorial pretest/posttest group design was used to evaluate the effectiveness of self-help smoking cessation methods at the worksite. The study investigated the effect of a multicomponent health education and skill intervention versus the effect of a monetary incentive to the employee for quitting. All employees received, in addition, a standardized self-help smoking cessation manual and maintenance manual. Following agreement to participate and a baseline smoking history, all participants were followed for 6 weeks, 6 months, and 12 months. Saliva was obtained for thiocyanate (SCN) analysis of smoking status. Of the estimated 2000 smokers at the site, 387 smokers were recruited. Employees were randomly assigned to one of four groups. Results of this random trial indicate that those employees receiving a multicomponent program were most successful in quitting and remaining abstinent. The monetary incentive appears to have no effect on quit rate.

Adult↗

PubMed2002

Westeinde sciatica trial: randomized controlled study of bed rest and physiotherapy for acute sciatica.

OBJECT: The authors conducted a study to compare the efficacies of three nonsurgical treatment strategies in patients with sciatica. Their hypothesis was that bed rest, physiotherapy, and continuation of activities of daily living (ADLs) (control treatment) are each of equivalent efficacy. METHODS: This randomized controlled trial was designed for comparison of bed rest, physiotherapy, and continuation of ADLs. The setting was an outpatient clinic. General practitioners were asked to refer patients for treatment as soon as possible. The authors enrolled 250 patients (< 60 years of age) with sciatica of less than 1-month's duration and who had not yet been treated with bed rest or physiotherapy. Primary outcome measures were radicular pain (based on a visual analog pain scale [VAPS]) and hampered ADLs (Quebec Disability Scale [QDS]). Secondary outcome measures were the rates of treatment-related failure and surgical treatment. Measures were assessed at baseline and during follow up at 1, 2, and 6 months. Mean differences in VAPS and QDS scores between bed rest and control treatment were 2.5 (95% confidence interval [CI] -6.4 to 11.4) and -4.8 (95% CI -10.6 to 0.9) at 1 month and 0.9 (95% CI -8.7 to 10.4) and -2.7 (95% CI -9.9 to 4.4) at 2 months, respectively. The respective differences between physiotherapy and control treatment were 0.8 (95% CI -8.2 to 9.8) and -0.5 (95% CI -6.3 to 5.3) at 1 month and -0.3 (95% CI -9.4 to 10) and 0.0 (95% CI -7.2 to 7.3) at 2 months. The respective odds ratios for treatment failure and surgical treatment of bed rest compared with control treatment were 1.6 (95% CI 0.8-3.5) and 1.5 (95% CI 0.7-3.6) at 6 months. When physiotherapy was compared with control treatment, these ratios were 1.5 (95% CI 0.7-3.2) and 1.2 (95% CI 0.5-2.9) at 6 months, respectively. CONCLUSIONS: Bed rest and physiotherapy are not more effective in acute sciatica than continuation of ADLs.

Activities of Daily Living↗

PubMed1999

Chemotherapeutic options in chronic lymphocytic leukemia: a meta-analysis of the randomized trials. CLL Trialists' Collaborative Group.

BACKGROUND: The randomized trials that evaluate the timing and intensity of initial chemotherapy for chronic lymphocytic leukemia (CLL) have, in general, been too small to provide separately reliable results. We compared the effects on survival of the following: a) immediate versus deferred chemotherapy for early-stage CLL and b) combination chemotherapy (e.g., cyclophosphamide and vincristine plus prednisone/prednisolone [COP] or COP plus doxorubicin [CHOP]) versus single-agent chlorambucil as first-line treatment for more advanced disease. METHODS: All relevant randomized trials, whether published or not, were sought for a collaborative meta-analysis involving centralized review of the data for each patient. RESULTS: There were 2048 patients with early disease in six trials of immediate versus deferred chemotherapy (chlorambucil or chlorambucil plus prednisone/prednisolone). The 10-year survival was slightly worse (but not statistically significantly so) with immediate chemotherapy (44% versus 47% survival; difference = -3%; 95% confidence interval [CI] = -10% to 4%). There were another 2022 patients in 10 trials of combination chemotherapy versus chlorambucil, with or without prednisone/prednisolone. The 5-year survival was 48 % in both cases (difference = 0%; 95% CI = -6% to 5%). A subgroup of six of these 10 trials involved an anthracycline-containing regimen but again overall survival appeared no better than with chlorambucil (anthracycline-based regimen: 325 deaths among 627 patients; chlorambucil: 306 deaths among 636 patients; death rate ratio = 1.07; 95% CI = 0.91-1.25; not statistically significant). CONCLUSIONS: In terms of survival, these trials support a conservative treatment strategy for CLL, i.e., no chemotherapy for most patients with early-stage disease, and single-agent chlorambucil as the first line of treatment for most patients with advanced disease, with no evidence of benefit from early inclusion of an anthracycline. This strategy will, however, need to be reconsidered as mature results become available from trials of other agents.

Antineoplastic Combined Chemotherapy Protocols↗