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Results for “Randomized trial”

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PubMed1998

Low-dose aspirin and risk of cataract and subtypes in a randomized trial of U.S. physicians.

PURPOSE: To examine whether low-dose aspirin (325 mg on alternate days) reduces the risk of age-related cataract and subtypes. This report extends previous findings, including both subtypes and additional newly identified incident cases since the earlier report. METHODS: All 20,979 participants in the Physicians' Health Study, a randomized trial of aspirin and beta-carotene among U.S. male physicians age 40-84 in 1982, who did not report cataract at baseline were included. Average follow-up was five years. The main outcome measure was incident, age-related cataract responsible for a reduction in best-corrected visual acuity to 20/30 or worse, based on self-report confirmed by medical record review. RESULTS: 501 age-related cataracts were diagnosed during follow-up, including 416 with nuclear sclerosis and 212 with a posterior subcapsular component; 318 cataracts progressed to surgical extraction. Overall, there were 245 cataracts in the aspirin group and 256 in the placebo group (relative risk [RR], 0.94; 95% confidence interval [CI], 0.79 to 1.13; P = 0.52). Cataract extractions were 19% less frequent in the aspirin than in the placebo group (RR, 0.81; 95% CI, 0.65 to 1.01; P = 0.06). In subgroup analyses of subtypes, aspirin takers had a lower risk of posterior subcapsular cataract (RR, 0.74; 95% CI, 0.57 to 0.98; P = 0.03) but not nuclear sclerosis (RR, 0.96; 95% CI, 0.79 to 1.16; P = 0.65) cataract. CONCLUSIONS: Overall, these randomized trial data tend to exclude a large benefit of five years of low-dose aspirin therapy on cataract development and extraction. The data are compatible with a modest benefit on cataract extraction for this duration of aspirin therapy. Subgroup analyses raise the possibility of a modest, but potentially important, protective effect of aspirin on posterior subcapsular cataract, a particularly disabling subtype.

Adult↗

PubMed1993

Results of a prospective randomized trial with neoadjuvant chemotherapy in stage IB, bulky, squamous carcinoma of the cervix.

A prospective randomized trial was carried out in patients with squamous carcinoma of the cervix uteri, stage Ib bulky. The protocol considers two arms: the control group (75 patients) and the neoadjuvant one (76 patients). All the patients were classified according to the FIGO staging system and in order to determine the tumor size objectively, an ultrasound scanning was done. After this a Wertheim-Meigs operation followed by adjuvant whole-pelvis irradiation was performed. In the neoadjuvant group the same procedures were carried out but three courses of chemotherapy with the "quick" VBP scheme were given before the treatment. The new therapeutic strategy proved to be very useful in bulky tumors in which the clinical examination showed a cervix increased in size and the ultrasound scanning a volume larger than 60 c.c. (> 4 x 4 x 4 cm). In those cases statistically significant differences were found between both groups when free disease interval and survival were considered. These were due to the fact that operability has been improved and the parametrial extension has been decreased as well as other risk factors such as vascular embolism, lymph node involvement, tumor-cervix quotient, and tumor volume. The use of this new strategy is not justified in small tumors (< 3-4 cm in diameter) because in those cases, survival is not improved with neoadjuvant therapy.

Adult↗

PubMed2005

Intercostal muscle flap reduces the pain of thoracotomy: a prospective randomized trial.

BACKGROUND: Thoracotomy is associated with significant pain and morbidity. METHODS: We performed a prospective randomized trial over 4 months. Patients were randomized to a standard posterior-lateral thoracotomy or an identical procedure, except an intercostal muscle was harvested from the lower rib (to protect the intercostal nerve) before chest retraction. To ensure an equal distribution among both groups, patients were stratified by race, sex, and type of pulmonary resection. All patients received similar pain management. Pain was assessed by using multiple pain scores during hospitalization and after discharge. Outcomes assessed were pain scores, spirometric values, analgesic use, and activity level. RESULTS: There were 114 patients. The median time for intercostal muscle harvesting was 3.7 minutes. The numeric pain scores were lower for the intercostal muscle group on postoperative days 1 and 2 and at weeks 1, 2, 3, 4, 8, and 12 (P < .05 for all). In addition, patients in the intercostal muscle group had a smaller decrease in spirometric values, were less likely to be using analgesics, and were more likely to have returned to normal activity. CONCLUSIONS: The harvesting of an intercostal muscle flap before chest retraction decreases the pain of thoracotomy and leads to a lower decrease in spirometry. In addition, patients have less pain at 1, 2, 3, 4, 8, and 12 weeks postoperatively and are less likely to be using narcotics. Finally, it offers a pedicled muscle flap that takes little time to harvest and is able to buttress all bronchi after lobectomy.

Aged↗

PubMed1995

Results of a prospective randomized trial using DTIC and interferon as adjuvant therapy for stage I malignant melanoma.

This prospective randomized trial evaluated the effect of DTIC and interferon as adjuvant therapy for high risk stage 1 malignant melanoma in 26 patients. Both groups were well matched for depth of disease, site of melanoma and other prognostic criteria. Like other studies the findings of 2.6 times increased relative risk of mortality in the treatment arm do not support a rationale for adjuvant immuno-chemotherapy even in patients at high risk of recurrence.

Adult↗

PubMed2002

The role of nucleoside analogues in the treatment of chronic lymphocytic leukemia-lessons learned from prospective randomized trials.

The newer purine nucleoside analogues (PNA), fludarabine (FAMP) and cladribine (2-chlorodeoxyadenosine, 2-CdA) have been synthesized recently and introduced into the treatment of chronic lymphocytic leukemia (CLL). The results of large phase II studies indicate that FAMP and 2-CdA are similarly active in CLL. Unfortunately, no prospective randomized study comparing the results of the treatment of CLL patients with FAMP and 2-CdA has been published so far. Significantly higher overall response (OR) and complete remission (CR) in patients treated initially with PNA than with chlorambucil or cyclophosphamide based combination regimens has been recently confirmed in five prospective multicentre randomized trials. These studies have also shown longer response duration in patients treated with PNA than with conventional chemotherapy. Overall survival progression free and events free survival were similar in patients treated with PNA and with chlorambucil or other alkylating agent based regimens. However, the majority of randomized trials were designed as cross over studies and most patients, treated with conventional chemotherapy were given PNA when refractory or in early relapse, which may influence the survival time. The results of a randomized study have shown a higher incidence of neutropenia and infections in patients treated with PNA than with chlorambucil. However. the frequency of autoimmune hemolytic anemia, pure red cell aplasia, secondary neoplasms and Richter's syndrome seems to be similar in patients treated with PNA and standard alkylating agents based chemotherapy. In conclusion, alkylating agents still have an important place in the routine management of the majority of CLL patients. They are in general safe, given on an out patients basis and significantly cheaper than PNA. PNA should be routinely used as second line treatment, and possibly as first line therapy in younger patients, who are candidates for potentially curative treatment such as stem cell transplantation and/or monoclonal antibodies.

Antineoplastic Agents↗

PubMed2005

Surgical management of colorectal cancer in the laparoscopic era: a review of prospective randomized trials.

The benefits of laparoscopy in benign diseases are quite clear. Patients generally can expect smaller incisions, less narcotic usage, quicker return of bowel function, and shorter hospitalizations. The benefits of laparoscopy in oncologic surgery are less clear, and laparoscopic oncology surgery has many critics. Early reports of long surgical times, high operating room costs, and alarming rates of port-site recurrences after laparoscopic colectomy for colorectal cancer all but stopped this less-invasive approach outside the confines of clinical protocols. As the results of larger retrospective studies began to refute these earlier detrimental claims, prospective randomized trials began to take a foothold. In this article, we review these randomized trials with particular attention to the perioperative effects of laparoscopic colectomy and the short-term oncologic outcomes.

Adenocarcinoma↗

PubMed1999

A three-day course of dexamethasone therapy to prevent chronic lung disease in ventilated neonates: a randomized trial.

BACKGROUND: Although several trials of early dexamethasone therapy have been completed to determine if such therapy would reduce mortality and chronic lung disease (CLD) in infants with respiratory distress, optimal duration and side effects of such therapy remain unknown. PURPOSE: The purpose of this study was: 1) to determine if a 3-day course of early dexamethasone therapy would reduce CLD and increase survival without CLD in neonates who received surfactant therapy for respiratory distress syndrome and 2) to determine adverse effects associated with such therapy. DESIGN: This was a prospective multicenter randomized trial comparing a 3-day course of dexamethasone therapy beginning at 24 to 48 hours of life to placebo therapy. Two hundred forty-one neonates (dexamethasone n = 118, placebo n = 123), who weighed between 500 g and 1500 g, received surfactant therapy, and were at significant risk for CLD or death using a model to predict CLD or death at 24 hours of life, were enrolled in the trial. Infants randomized to receive early dexamethasone were given 6 doses of dexamethasone at 12-hour intervals beginning at 24 to 48 hours of life. The primary outcomes compared were survival without CLD and CLD. CLD was defined by the need for supplemental oxygen at the gestational age of 36 weeks. Complication rates and adverse effects of study drug therapy were also compared. RESULTS: Neonates randomized to early dexamethasone treatment were more likely to survive without CLD (RR: 1.3; 95% CI: 1.03, 1.7) and were less likely to develop CLD (RR: 0.6; CI: 0.3, 0. 98). Mortality rates were not significantly different. Subsequent dexamethasone therapy use was less in early dexamethasone-treated neonates (RR: 0.8; CI: 0.7, 0.96). Very early (</=7 days of life) intestinal perforations were more common among dexamethasone-treated neonates (8% vs 1%). CONCLUSION: We conclude that an early 3-day course of dexamethasone therapy increases survival without CLD, reduces CLD, and reduces late dexamethasone therapy in high-risk, low birth weight infants who receive surfactant therapy for respiratory distress syndrome. Potential benefits of early dexamethasone therapy at the dosing schedule used in this trial need to be weighed against the risk for early intestinal perforation.

Analysis of Variance↗

PubMed1998

Erythropoietin to minimize perioperative blood transfusion: a systematic review of randomized trials. The International Study of Peri-operative Transfusion (ISPOT) Investigators.

Our aim was to perform a systematic review to determine the efficacy and side-effects of erythropoietin, given with or without autologous predonation, to patients undergoing orthopaedic or cardiac surgery. A number of studies have been done to determine whether erythropoietin minimizes exposure to perioperative allogeneic red cell transfusion. A systematic review of all randomized trials will provide the best estimate of the efficacy and side-effects of erythropoietin therapy. All randomized trials of erythropoietin in cardiac or orthopaedic surgery that reported the proportion of patients receiving perioperative allogeneic transfusion were included. The efficacy of erythropoietin was evaluated in subgroups of patients depending upon the route of administration, dose of erythropoietin, the type of control and the methodological quality of the study report. The odds ratio for the proportion of patients transfused with allogeneic blood in studies of erythropoietin to augment autologous donation was 0.42 (95% confidence limits 0.28-0.62; P < 0.0001) for orthopaedic surgery and 0.25 (95% CI 0.08-0.82; P = 0.02) for cardiac surgery. The odds ratio for erythropoietin alone was 0.36 (95% CI 0.24-0.56; P = 0.0001) in orthopaedic surgery and 0.25 (95% CI 0.06-1.04; P < 0.06) in cardiac surgery. The route of administration, dose of erythropoietin, type of control and methodological quality of the study report had no statistically significant effect upon the odds ratios. Although there was no convincing evidence that erythropoietin used alone increased the frequency of thrombotic complications, some studies found an excess of events in erythropoietin-treated patients, and the number of patients studied was relatively small. Erythropoietin, when given alone or to augment autologous donation, decreased exposure to perioperative allogeneic transfusion in orthopaedic and cardiac surgery. Further studies are required to definitively establish the safety of erythropoietin alone, to determine the optimal dose of perioperative erythropoietin, and to compare its efficacy and cost-effectiveness with other methods of minimizing perioperative transfusion.

Blood Transfusion↗

PubMed1988

Cost-effectiveness of cancer chemotherapy: an economic evaluation of a randomized trial in small-cell lung cancer.

An economic evaluation of a randomized trial of cyclophosphamide, Adriamycin (doxorubicin; Adria Laboratories, Columbus, OH), and vincristine alone or alternating with etoposide (VP-16) and cisplatin in extensive small-cell lung cancer (SCLC) was undertaken. A survival benefit of 1.6 months in favor of alternating chemotherapy was associated with an additional cost of $450 (1984 Canadian dollars) per patient. This translated to a cost of $3,370 per year of life gained. Sensitivity analyses demonstrated that the cost-effectiveness (CEA) of alternating chemotherapy was greatest when treatment was given on an outpatient basis. The results of the evaluation were sensitive to hospitalization rates, but even the most unfavorable analyses revealed the CEA of alternating chemotherapy to be comparable to that of treatments of common nonmalignant diseases. It is concluded that the CEA of alternating chemotherapy for SCLC was favorable when compared with accepted treatments for nonmalignant diseases. The survival benefit seen with alternating chemotherapy was felt to be clinically significant and alternating chemotherapy is recommended as routine therapy for extensive SCLC.

Antineoplastic Combined Chemotherapy Protocols↗

PubMed2006

Improving empirical antibiotic treatment using TREAT, a computerized decision support system: cluster randomized trial.

BACKGROUND: Appropriate antibiotic treatment decreases mortality, while superfluous treatment is associated with antibiotic resistance. We built a computerized decision support system for antibiotic treatment (TREAT) targeting these outcomes. METHODS: Prospective cohort study comparing TREAT's advice to physician's treatment followed by a cluster randomized trial comparing wards using TREAT (intervention) versus antibiotic monitoring without TREAT (control). We included patients suspected of harbouring bacterial infections in three hospitals (Israel, Germany and Italy). The primary outcome, appropriate antibiotic treatment, was assessed among patients with microbiologically documented infections (MDI). Length of hospital stay, adverse events, mortality (interventional trial) and antibiotic costs (both studies), including costs related to future antibiotic resistance, were compared among all included patients. RESULTS: Among 1203 patients included in the cohort study (350 with MDI), TREAT prescribed appropriate empirical antibiotic treatment significantly more frequently than physicians (70% versus 57%, P < 0.001) using less broad-spectrum antibiotics at half physicians' antibiotic costs. The randomized trial included 2326 patients, 570 with MDI. The rate of appropriate empirical antibiotic treatment was higher in intervention versus control wards [73% versus 64%, odds ratio (OR): 1.48, 95% confidence interval (CI): 0.95-2.29, intention to treat, adjusted for location and clustering]. For patients treated according to TREAT's advice in intervention wards, the difference with controls was highly significant (OR: 3.40, 95% CI: 2.25-5.14). Length of hospital stay, costs related to future resistance and total antibiotic costs were lower in intervention versus control wards. CONCLUSIONS: TREAT improved the rate of appropriate empirical antibiotic treatment while reducing antibiotic costs and the use of broad-spectrum antibiotic treatment.

Adolescent↗

PubMed1986

Randomized trials of high-versus-low-dose steroids in renal transplantation. Does the evidence favor a consensus?

Published, randomized trials of high-versus-low-dose steroids in renal transplantation, individually and collectively, are too small (median trial size: 72 patients) to reach authoritative conclusions about mortality, graft failure, transplant failure, and the incidence of certain complications. The implications of this review for future therapeutic trials in renal transplantation are that randomization of 400 patients should be seen as minimum Phase III trial size, and that a research strategy is needed to encourage effective multicenter collaboration. One such strategy is described beginning with a single-center randomized Phase II trial to compare times to first rejection episode, thus rendering prior evidence on which the case for multicenter collaboration, effectively in an established trial, can be judged. Analysis by intention to treat and consistent reporting of the number of patients who experience certain classes of complication are two of four ground rules on which we assessed trials when combining evidence from similar studies. The other ground rules are randomization and common treatment theme. The statistical method of formally pooling results is outlined.

Clinical Trials as Topic↗

PubMedDate not supplied

Endoscopic ligation of esophageal varices compared with injection sclerotherapy: a prospective randomized trial.

Fifty cirrhotic patients with esophageal varices underwent endoscopic treatment in a prospective randomized trial carried out to compare variceal ligation with injection sclerotherapy, with respect to safety, efficacy, and complications in the initial session. Twenty-five patients each were treated using endoscopic variceal ligation or endoscopic injection sclerotherapy in the initial session and then only endoscopic injection sclerotherapy for all following sessions. Ligations numbered 4.1 at the initial session. The total number of sessions of endoscopic injection sclerotherapy was 4.0 +/- 1.3 in the endoscopic injection sclerotherapy group compared with 3.6 +/- 1.4 in the endoscopic variceal ligation group. The total volume of the sclerosant used by the end of all the sessions was 23.9 +/- 10.3 ml in the endoscopic variceal ligation group and 39.0 +/- 11.5 ml in the endoscopic injection sclerotherapy group (p < 0.0001). In all patients, complete eradication of the varices was achieved, and at 7 to 15 months follow-up no evidence of recurrence was seen. Adverse effects such as pyrexia, chest pain, and pleural effusion after the initial session were significantly lower in the endoscopic variceal ligation group (p < 0.05), and total bilirubin, serum creatinine, lactate dehydrogenase, and urinary beta 2-microglobulin were significantly increased and PaO2 decreased after endoscopic injection sclerotherapy (p < 0.05). This study shows that endoscopic variceal ligation significantly decreased the adverse effects associated with endoscopic injection sclerotherapy in the initial session, and it is recommended as an alternative to sclerotherapy.

Aged↗

PubMed1999

Efficacy of computerized decision support for mechanical ventilation: results of a prospective multi-center randomized trial.

200 adult respiratory distress syndrome patients were included in a prospective multicenter randomized trial to determine the efficacy of computerized decision support. The study was done in 10 medical centers across the United States. There was no significant difference in survival between the two treatment groups (mean 2 = 0.49 p = 0.49) or in ICU length of stay between the two treatment groups when controlling for survival (F(1df) = 0.88, p = 0.37.) There was a significant reduction in morbidity as measured by multi-organ dysfunction score in the protocol group (F(1df) = 4.1, p = 0.04) as well as significantly lower incidence and severity of overdistension lung injury (F(1df) = 45.2, p < 0.001). We rejected the null hypothesis. Efficacy was best for the protocol group. Protocols were used for 32,055 hours (15 staff person years, 3.7 patient years or 1335 patient days). Protocols were active 96% of the time. 38,546 instructions were generated. 94% were followed. This study indicates that care using a computerized decision support system for ventilator management can be effectively transferred to many different clinical settings and significantly improve patient morbidity.

Adult↗

PubMed2001

An open-label randomized trial to evaluate different therapeutic strategies of combination therapy in HIV-1 infection: design, rationale, and methods of the initio trial.

This article discusses the design of an ongoing open-label, randomized trial comparing three strategies of initial and subsequent HIV therapy in terms of long-term immunological and virological effect. The three treatment arms are (1) didanosine (ddI) plus stavudine (d4T) plus efavirenz (EFV) followed by zidovudine (ZDV) plus lamivudine (3TC) plus abacavir (ABC) plus nelfinavir (NFV); (2) ddI plus d4T plus NFV followed by ZDV plus 3TC plus ABC plus EFV; (3) ddI plus d4T plus EFV plus NFV followed by ZDV plus 3TC plus ABC plus saquinavir plus ritonavir. The primary objective is to determine whether it is best to start with a protease inhibitor (PI)-containing regimen, a non-nucleoside analogue reverse transcriptase inhibitor (NNRTI)-containing regimen, or with a regimen containing both a PI and an NNRTI. The aim is to recruit over 1000 patients followed for at least 3 years. The entry criteria are broad with no restriction on stage of disease, CD4 count, or HIV viral load. The criteria for therapeutic failure determining change of treatment are not defined and are left to the clinicians, but randomization is stratified by country and by the current criteria used for changing treatment. We describe the rationale behind various aspects of the design and discuss the complexities involved in undertaking such a large trial in HIV-infected patients from 180 clinical sites in 17 countries. Control Clin Trials 2001;22:160-175

Adult↗

PubMed2001

Prospective, randomized trial comparing laparoscopic vs. conventional surgery for refractory ileocolic Crohn's disease.

INTRODUCTION: Surgeons have been reluctant to apply laparoscopic techniques to Crohn's disease surgery because of concerns with evaluating and excising inflamed tissue using laparoscopic methods. Additionally in Crohn's disease surgery, laparoscopic techniques have not been demonstrated to have clear advantages over conventional ones. METHOD: We conducted a prospective, randomized trial in one surgical department comparing laparoscopic vs. conventional techniques in 60 patients (25 males), median age 34.4 (range, 10-60.1) years, undergoing elective ileocolic resection for refractory Crohn's disease. Postoperatively, all patients underwent measurement of pulmonary function tests every 12 hours, and were treated identically on a highly controlled protocol with regard to analgesic administration, feeding, and postoperative care. RESULTS: Of the 31 patients assigned to laparoscopic and 29 to the conventional group, all had isolated Crohn's disease of the terminal ileum plus or minus the cecum. Median length of the incision was 5 cm in the laparoscopic group and 12 cm in the conventional group. Overall recovery of 80 percent of forced expiratory volume (one second) and forced vital capacity was a median of 2.5 days for laparoscopic and 3.5 days for conventional (P = 0.03). There was no difference in the amount of morphine equivalents used between groups postoperatively. Flatus and first bowel movement returned a median of 3 and 4 days, respectively, after laparoscopic vs. 3.3 and 4 days, respectively, after conventional surgery (P = 0.21). Median length of stay was five (range, 4-30) days for laparoscopic, and six (range, 4-18) days for conventional surgery. Major complications occurred in one patient in each group. Minor complications occurred in four laparoscopic and eight conventional patients (P < 0.05). There were no deaths. Two laparoscopic patients were converted to conventional as a result of adhesions or inflammation. All patients recovered well and there were no clinical recurrences in the follow-up period (median, 20; range, 12-45 months). CONCLUSIONS: Within a single institution, single surgical team, prospective, randomized trial, laparoscopic techniques offered a faster recovery of pulmonary function, fewer complications, and shorter length of stay compared with conventional surgery for selected patients undergoing ileocolic resection for Crohn's disease.

Adolescent↗

PubMed1988

Short-term prophylaxis with cefotaxime in colorectal surgery. A prospective, randomized trial.

In a controlled, randomized study the effect of penicillin and streptomycin on postoperative septic complications in colorectal surgery (penicillin, 2 ml, IU, intramuscularly, three times daily for a period of six days and concomitantly streptomycin, 0.5 gm, intramuscularly, two times daily for a period of four days) was compared with the effect of cefotaxime, 2 gm, intravenously, three times on the day of surgery. One hundred patients completed the study: 48 were treated with penicillin and streptomycin (Group 1) and 52 with cefotaxime (Group 2). Wound infection occurred in one patient (2.1 percent) in Group 1, but not in Group 2 (0%, N.S.). Rupture of the wound occurred in one patient in each group (2.1 percent vs. 1.9 percent, N.S.). Insufficiency of the anastomosis occurred in four patients in Group 1 (8.3 percent) and in one patient in Group 2 (1.9 percent). It is concluded that short-term prophylaxis with cefotaxime is as effective as long-term prophylaxis with penicillin and streptomycin.

Adult↗

PubMed1996

The tension-free hernioplasty in a randomized trial.

BACKGROUND: The tension-free hernioplasty as introduced by Lichtenstein has gained increasing acceptance during the last decade although the technique has not been evaluated in a randomized trial. METHODS: This randomized study compares the 2-year follow-up results after 102 tension-free hernioplasties with implantation of a prolene mesh in all groin hernias to 53 Cooper ligament repairs in direct hernias and 53 abdominal ring repairs in indirect hernias. RESULTS: After tension-free repairs five hernias recurred (5%), and after either Cooper ligament or abdominal ring repair, 16 recurrences were found (15%) (P = 0.025). No indirect hernias recurred after a tension-free repair; 2 recurred after abdominal ring repair (4%; NS). The recurrence rate after tension-free repairs for primary direct inguinal hernias was 7% as compared with 30% after Cooper ligament repair (P = 0.0081). No difference in complication rate between the tested methods was found. CONCLUSION: Recurrence rate is reduced to one-third after tension-free herniotomies as compared with the conventionel herniotomies without increase in complication rate.

Absenteeism↗

PubMed2000

Use of a screen log to audit patient recruitment into multiple randomized trials in the intensive care unit. Canadian Critical Care Trials Group.

OBJECTIVE: To develop and evaluate a screen log for monitoring enrollment in multiple randomized clinical trials conducted in a single center. SETTING: University-affiliated 20-bed tertiary care medical-surgical intensive care unit (ICU). PATIENTS: Consecutive ICU patients admitted between April 1995 and March 1997. METHODS: We developed a screen log for multicentered studies conducted in our ICU. Using a multiple-project, unicenter perspective, we evaluated the screen log as a tool for monitoring eligibility and enrollment of patients in four multicentered randomized trials focused on stress ulcer prophylaxis, blood transfusion thresholds, immunotherapy for sepsis and mechanical ventilation strategies. RESULTS: The screen log was used as an instrument to monitor trial execution. We recorded all aspects of study enrollment and created a taxonomy of reasons for nonenrollment into each trial. We calculated enrollment efficiency rates and used these data to develop strategies to maximize accrual. The screen log became a communication tool that fostered research-oriented continuous quality improvement initiatives for the management of concurrently conducted randomized trials in our ICU. CONCLUSIONS: Intensivists participating in several clinical trials may be interested in monitoring and maximizing enrollment when conducting multiple studies and understanding the influence of each trial on enrollment into the others. The unicenter, multiple-project screen log is one tool that may help to achieve these goals.

Canada↗