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Results for “Randomized trial”

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At least 1,081 records · Page 60Linked to original sources

PubMed1979

Randomized trial of empiric antibiotic therapy with ticarcillin in combination with gentamicin, amikacin or netilmicin in febrile patients with granulocytopenia and cancer.

A randomized trial of ticarcillin plus gentamicin (group 1), ticarcillin plus amikacin (group 2) and ticarcillin plus netilmicin (group 3) as empiric antibiotic therapy in patients with granulocytopenia and cancer was carried out at the Baltimore Cancer Research Center. The response rate for all infections was 97 per cent in group 1, 91 per cent in group 2 and 95 per cent in group 3. Patients with bacteremias showed improvement in 93 per cent (group 1), 78 per cent (group 2) and 82 per cent (group 3) of cases. All failures were among patients with gram-negative bacteremias. Both antibiotic susceptibility of the bacteremic organism and granulocyte recovery correlated with patient improvement. Nephrotoxicity and ototoxicity were rare and were not significantly different in three groups of patients. Therefore, ticarcillin plus gentamicin, ticarcillin plus amikacin and ticarcillin plus netilmicin appear to be equally efficacious and minimally toxic in this patient population. Excellent over-all results can be expected with these combinations provided the etiologic agent is susceptible.

Adolescent↗

PubMed2000

Adherence to protein restriction in patients with type 2 diabetes mellitus: a randomized trial.

OBJECTIVE: To describe the extent to which diet counselling can decrease protein intake, and to identify predictors of adherence. DESIGN: (1) Randomized trial; (2) observational longitudinal study. SUBJECTS: (1) 125 type 2 diabetic patients in primary care; (2) 59 patients in the experimental group. INTERVENTION: For a period of 12 months, dieticians provided guidance on protein restriction (experimental group, n=59) or the usual dietary advice (control group, n=66). OUTCOME MEASURES: Adherence was estimated primarily from urinary urea excretion (UUE), but also from food-frequency questionnaires (FFQ). RESULTS: After 6 months protein intake was, according to the UUE and the FFQ, respectively, 8 g/day (95% CI -2, 13) (8%) and 15 g/day (95%-CI 9, 22) (16%) lower in the experimental than in the control group. After 12 months these differences were smaller. Linear regression analysis indicated that protein restriction was greater in patients who were well satisfied with their pre-existing diet (r=0.32, bper 1/10=3.6 (1, 6) g), in patients who were less overweight (r=0.32, bper kg.m-2=1.1 (0.2, 2. 0) g), and in patients living alone (r=0.22, b=7.7 (-2, 17) g). These combined factors explained only 11% of variation in adherence. Adherence was not predicted by the number of barriers reported by the patients or by coinciding changes in diet satisfaction. CONCLUSIONS: The diet counselling resulted in a very moderate degree of protein restriction only. Predictors of adherence could be identified, but only a few, and their predictive power was limited.

Aged↗

PubMed1996

Randomized trial of vinorelbine compared with fluorouracil plus leucovorin in patients with stage IV non-small-cell lung cancer.

PURPOSE: This prospective randomized trial was performed to compare the effectiveness of intravenous vinorelbine tartrate with intravenous fluorouracil and leucovorin (5-FU/LV) on the primary end points of survival, quality of life (QOL), and relief of cancer-related symptoms in patients with advanced non-small-cell lung cancer (NSCLC). Secondary end points included tumor response rates and time to treatment failure. In addition, the safety of both treatment regimens was evaluated in this multicenter study. PATIENTS AND METHODS: Two hundred sixteen patients with stage IV NSCLC were enrolled onto this study from 18 centers. Vinorelbine was administered at a dose of 30 mg/m2/wk. 5-FU/LV was administered at a dose of 425 mg/m2 and 20 mg/m2, respectively, for 5 consecutive days every 4 weeks. Patients with progressive disease or toxicity were removed from study while responding and stable patients were continued on therapy. RESULTS: The median survival time of patients who received vinorelbine was 30 weeks, with 25% of patients alive at 1 year, compared with a median survival time of 22 weeks and 16% of patients alive at 1 year for those treated with 5-FU/LV (P = .03, log-rank test). This improvement in survival was associated with a higher objective response rate (12% v 3%) and time to treatment failure (10 weeks v 8 weeks) for vinorelbine versus 5-FU/LV. The dose-limiting toxicity of vinorelbine was granulocytopenia, with 54% of patients experiencing grade 3/4 granulocytopenia. Nonhematologic toxicity of vinorelbine was generally grade 1 or 2. The most common grade 3 toxicities were related to injection-site reactions. CONCLUSION: This trial confirms the efficacy of vinorelbine in patients with advanced NSCLC. The clinical activity and relatively favorable toxicity profile of this agent make it a reasonable and useful treatment option in the management of patients with this disease.

Adult↗

PubMed2006

Simvastatin improves biochemical parameters in women with polycystic ovary syndrome: results of a prospective, randomized trial.

OBJECTIVE: To test the hypothesis that statins improve hyperandrogenemia in women with polycystic ovary syndrome (PCOS). DESIGN: Prospective, randomized trial. SETTING: Academic medical center. PATIENT(S): Forty-eight women with PCOS. INTERVENTION(S): Subjects were randomized to a statin group (simvastatin, 20 mg daily plus oral contraceptive pill [OCP]; n = 24) or an OCP group (OCP alone; n = 24). MAIN OUTCOME MEASURE(S): Serum T. RESULT(S): Baseline parameters of both groups were comparable. After 12 weeks of treatment, serum T levels declined by 41% in the statin group and by 14% in the OCP group. In the statin group, there was a greater decrease of LH (43% decrease vs. 9% in the OCP group) and a greater decline of LH/FSH ratio (44% vs. 12%). In the statin group, total cholesterol declined by 10% and low-density lipoprotein (LDL) by 24%. In the OCP group, total cholesterol increased by 8%, and LDL was unchanged. CONCLUSION(S): This is the first study demonstrating that statin decreases T levels and normalizes gonadotropin levels in women with PCOS. Statin therapy might offer a novel approach, providing endocrine and cardiovascular benefits.

Adult↗

PubMedDate not supplied

A randomized trial of team care following stroke.

A randomized controlled trial was conducted to examine the effects of interdisciplinary team care on acute hospitalized stroke patients. After obtaining baseline information on 42 stroke victims receiving conventional care in a general hospital, 130 stroke patients were stratified and randomly assigned either to Traditional or Team care. Assessments by independent evaluators permitted comparisons between Team and Traditional groups with reference to patient survival, motor performance and functional abilities. Data obtained prospectively from charts and treatment logs allowed the care process across groups to be compared. Results demonstrated that Team and Traditional patients fared similarly in survival. However there was an unexpected difference in survival depending upon sex. For motor performance, male survivors performed better with Team care and female survivors with the Traditional method. In terms of functional abilities, male patients receiving Team care again performed better than their Traditional counterparts, whereas in women there was no difference between the treatment groups.

Activities of Daily Living↗

PubMedDate not supplied

Adjuvant chemotherapy in gastric cancer: a meta-analysis of randomized trials and a comparison with previous meta-analyses.

AIMS AND BACKGROUND: Up to now adjuvant chemotherapy after curative resection for gastric cancer (GC) has been considered an experimental approach. The results of existing phase III randomized trials comparing chemotherapy with control after surgery are controversial. Three meta-analyses have been published in recent years. It is likely that each of them presents a theoretical bias, mainly as regards the inclusion criteria of the trials. In this article we re-examine this potential bias, highlighting the differences between the present and past meta-analyses on adjuvant chemotherapy for GC. METHODS: Only randomized controlled clinical trials comparing systemic adjuvant chemotherapy with control after radical resection of GC were eligible. Total mortality was assessed as outcome measure of the treatment effect and a pooled odds ratio was calculated using the Peto-Mantel-Haenszel method. RESULTS: After the selection process 17 papers (18 comparisons) proved eligible for inclusion in the meta-analysis with a total of 3118 patients, of whom 1546 randomized to the treatment arms and 1572 to the control arms; 762 and 871 deaths occurred in the treatment and control arms, respectively. Statistical analysis suggests an absence of significant heterogeneity between the trials and a significant advantage in survival for adjuvant chemotherapy (pooled odds ratio, 0.72, 95% Cl, 0.62-0.84). CONCLUSIONS: Our meta-analysis would seem to indicate that adjuvant chemotherapy results in a significant survival advantage in patients with GC. However, this observation undoubtedly requires confirmation in large randomized controlled trials including cisplatin before adjuvant chemotherapy after curative resection for GC can be proposed for use in clinical practice.

Antineoplastic Combined Chemotherapy Protocols↗

PubMed2002

A randomized trial of systematic nodal dissection in resectable non-small cell lung cancer.

PURPOSE: We conducted a randomized trial to investigate whether systematic nodal dissection (SND) is superior to mediastinal lymph nodal sampling (MLS) in surgical treatment of non-small cell lung cancer (NSCLC). METHODS: The patients resectable clinical Stage I-IIIA NSCLC were randomly assigned to lung resection combined with SND or lung resection combined with MLS. After postoperative pathological re-staging, eligible cases were followed up until 30 November 2000. The Kaplan-Meier method was used for survival analysis. COX proportional hazards model was used for prognostic analysis. RESULTS: Of the 532 patients who were enrolled in the study, 268 patients were assigned to lung resection combined with SND and 264 were assigned to lung resection combined with MLS. After surgical restaging only 471 cases were eligible for follow-up. The median survival was 59 months in the group given SND and 34 months in the group given MLS (P=0.0000 by the log rank test). There was significant difference in survival in Stage I (5-year survival 82.16 vs. 57.49%) and Stage IIIA (26.98 vs. 6.18%) by the log rank test and Breslow test. There was no significant yet marginal difference in survival by log rank test (10-year survival 32.04 vs. 26.92%, P=0.0523) but significant difference in survival by Breslow test (5-year survival 50.42 vs. 34.05%, P=0.0284) in Stage II. Types of mediastinal lymph node dissection, pTNM stage, tumor size and number of lymph node metastasis were four factors that influenced long-term survival rate by multivariate analysis. CONCLUSIONS: As compared with MLS, lobectomy (pneumonectomy) combined with SND can improve survival in resectable NSCLC.

Adult↗

PubMed2001

Pragmatic randomized trial of home visits by a nurse to elderly people with hypertension in Mexico.

BACKGROUND: In Mexico, hypertension is a major cause of disability and death in the elderly, but the most effective way to promote behaviour change in old people is unknown. Low resource interventions that are effective in normal healthcare settings are urgently needed. We report the results of a randomized trial of nurse-provided health and lifestyle advice during home visits to elderly people with hypertension in Mexico City. METHODS: Subjects were 718 people with hypertension aged > or =60 years, who were residents of Mexico City and were registered with the Family Medicine Clinics of the Mexican Institute of Social Security (IMSS). A randomized controlled trial was carried out in which the intervention group was offered nurse visits over 6 months with blood pressure checks and negotiated lifestyle changes. The control group continued to receive usual care. RESULTS: After 6 months, 36.5% of the intervention versus 6.8% of the control group had a blood pressure of <160/90 mmHg. The difference in the mean change in systolic blood pressure was 3.31 mmHg (P = 0.03, 95% CI : 6.32, 0.29) and the same difference in diastolic blood pressure was 3.67 mmHg (P = 0.00, 95% CI : 5.22, 2.12). Weight and sodium excretion fell more in the intervention group, but the difference was not significant. CONCLUSIONS: Nurse home visits are effective in reducing blood pressure in hypertensive patients aged > or =60 years.

Aged↗

PubMedDate not supplied

Cyclosporine and azathioprine immunosuppression without maintenance steroids: a prospective randomized trial.

Since the commencement of the St. Vincent's Transplant Programme, 41 patients have undergone orthotopic heart transplantation, with low-dose cyclosporine and prednisolone as maintenance immunosuppression. An actuarial survival rate of 75% at 1 year resulted. To reduce early rejection-related death, azathioprine was chosen as an augmenting immunosuppressive agent to be administered as a prospective randomized trial. Sixty patients were randomized; 29 received low-dose cyclosporine plus azathioprine plus prednisolone (group A). Thirty-one patients received cyclosporine and azathioprine alone (group B). Both groups received a 7-day course of antithymocyte gamma globulin. One group B patient who underwent retransplantation was not analyzed. Actuarial survival for group A was 92% and group B 93%. The overall incidence of rejection for group A was 1.1 per patient and group B, overall, 2.3 episodes per patient. Group B patients who had persistent rejections were converted to group A protocol. Nine group B patients (30%) required conversion to maintenance steroids (group C). The overall incidence of infection was 1.6 episodes per patient and 1.3 episodes per patient for group A and group B, respectively. Two early deaths in group B and one in group A were unrelated to immunosuppressive protocol. One group A patient died at day 280 of multiorgan failure. There were no rejection- or infection-related deaths in the series. Hypertension occurred with equal frequency in both study groups. The cyclosporine and azathioprine protocol produces actuarial survival and morbidity rates comparable to those of a matched triple-therapy group. Thirty percent of patients in this protocol, however, will require maintenance steroids.

Actuarial Analysis↗

PubMed2001

Randomized trial of the quantitative and functional antibody responses to a 7-valent pneumococcal conjugate vaccine and/or 23-valent polysaccharide vaccine among HIV-infected adults.

In a double-blinded, randomized trial, human immunodeficiency virus (HIV)-infected adults with > or = 200 CD4 cells/microl received placebo (PL), 7-valent conjugate, or 23-valent pneumococcal polysaccharide (PS) vaccine in one of the following two-dose combinations given 8 weeks apart: conjugate-conjugate, conjugate-polysaccharide, placebo-polysaccharide, placebo-placebo. A total of 67 persons completed the study. Neither significant increases in HIV viral load nor severe adverse reactions occurred in any group. After controlling for confounders, when compared with persons receiving placebo-polysaccharide, persons receiving conjugate-conjugate and conjugate-polysaccharide had higher antibody concentrations (serotypes 4, 6B, 9V and serotype 23F, respectively) and opsonophagocytic titers (functional antibody assay, serotypes 9V, 23F and serotypes 4, 6B, 9V, respectively) after the second dose (P<0.05). The second dose with either conjugate or polysaccharide following the first conjugate dose, however, produced no further increase in immune responses.

Adult↗

PubMed2003

Treatment of Trichomonas in pregnancy and adverse outcomes of pregnancy: a subanalysis of a randomized trial in Rakai, Uganda.

OBJECTIVE: The purpose of this study was to assess the association of presumptive Trichomonas vaginalis treatment during pregnancy and birth outcomes. STUDY DESIGN: A community-randomized trial of presumptive sexually transmitted disease treatment during pregnancy was conducted between 1994 and 1999 in Rakai district, Uganda. A subanalysis of a trial of presumptive therapy with azithromycin, cefixime, and metronidazole assessed Trichomonas vaginalis treatment in pregnant women. RESULTS: Children of 94 women with Trichomonas who were treated had increased low birth weight (relative risk, 2.49; 95% CI, 1.12-5.50), preterm birth rate (relative risk, 1.28; 95% CI, 0.81-2.02), and 2-year mortality rate (relative risk, 1.58; 95% CI, 0.99-2.52), compared with children of 112 women with Trichomonas who were not treated. CONCLUSION: Treatment of Trichomonas vaginalis during pregnancy may be deleterious, and we infer that this may be due to metronidazole. This is consistent with a National Institute for Child Health and Human Development trial that found an excess of preterm births in children of women with Trichomonas vaginalis infection who were treated with metronidazole.

Animals↗

PubMed1998

A prospective randomized trial of blastocyst culture and transfer in in-vitro fertilization.

The effectiveness of blastocyst culture and transfer in human in-vitro fertilization (IVF) was evaluated in a prospective randomized trial in patients having a moderate to good response to gonadotrophin stimulation. Embryos were transferred either on day 3 after culture to around the 8-cell stage in Ham's F-10 medium supplemented with fetal cord serum, or on day 5 after culture to the blastocyst stage in the sequential serum-free media G 1.2 and G 2.2. The pregnancy rates after transfer on day 3 or day 5 were equivalent, 66 and 71% respectively; however, significantly more embryos were transferred on day 3 (3.7) than on day 5 (2.2). The number of blastocysts transferred did not affect the implantation rate, and pregnancy rates when either two or three blastocysts were transferred were 68 and 87% respectively. The implantation rate of the blastocysts (50.5% fetal heart beat) was significantly higher compared to the cleavage stage embryos transferred on day 3 (30.1%). The percentage of blastocyst development was not affected by the number of 2-pronuclear embryos, or by maternal age. Irrespective of the number of blastocysts formed, pregnancy rates were similar. Furthermore, the pregnancy rate following blastocyst transfer in patients with 10 or more follicles at the time of human chorionic gonadotrophin administration was not affected by patient age. More than 60% of patients having blastocyst culture and transfer had supernumerary embryos for cryopreservation. The establishment of a pregnancy following thaw and transfer confirmed the viability of cryopreserved blastocysts cultured in the absence of serum or co-culture. The ability to transfer just two blastocysts while maintaining high pregnancy rates will therefore help to eliminate high order multiple gestations and improve the overall efficiency of human IVF.

Adult↗

PubMed1983

Randomized trial of truncal vagotomy with either pyloroplasty or pyloric dilatation in the surgical management of chronic duodenal ulcer.

A randomized trial of 41 patients undergoing truncal vagotomy with pyloroplasty (TV + P) or truncal vagotomy with graded pyloric dilatation (TV + PD) for chronic duodenal ulcer is reported after mean follow-up of 34 months. There was no evidence of gastric stasis in patients who did not have a pyloroplasty. Liquid gastric emptying studies showed an increased rate of gastric emptying postoperatively in patients both with and without pyloroplasty. Overall clinical gradings at review were similar in both groups although there were more patients who were completely symptom free in the group with pyloric dilatation accompanying vagotomy.

Adult↗

PubMed2003

5-year outcome of a prospective randomized trial to compare transurethral electrovaporization of the prostate and standard transurethral resection.

OBJECTIVES: To update our prospective randomized trial comparing the safety, efficacy, and durability of transurethral electrovaporization of the prostate (TUVP) using the VaporTrode with standard transurethral resection of the prostate (TURP). METHODS: A total of 104 patients, taken from the waiting list for surgery for benign prostatic hyperplasia were randomized to TUVP (52 patients, mean age 67.5 years) or TURP (52 patients, mean age 70.2 years). In each group, 51, 47, and 40 patients completed 1, 2, and 3 years of follow-up, respectively. Of the 104 patients, 27 TURP and 26 TUVP patients completed 5 years of follow-up. RESULTS: Both groups were comparable in terms of the mean preoperative International Prostate Symptom Score, quality-of-life score, maximal urinary flow rate, and postvoid residual volume. The follow-up data at 5 years showed a significant and maintained improvement in the mean International Prostate Symptom Score (TUVP: 5.9 +/- 6.3 versus TURP: 8.6 +/- 7.1, P = 0.16), quality-of-life score (TUVP: 1.1 +/- 1.2 versus TURP: 1.7 +/- 1.4, P = 0.09), and mean maximal urinary flow rate (TUVP: 21 +/- 9 mL/s versus TURP: 17.9 +/- 13.1 mL/s, P = 0.17), with decreases in the mean postvoid residual volume (TUVP: 27.3 +/- 44.3 mL versus TURP: 10.7 +/- 13.1 mL, P = 0.08). Two patients in each group (4%) developed urethral strictures. Two TURP patients (4%) developed bladder neck strictures compared with one TUVP patient (2%). In each arm, 7 patients (13%) underwent reoperation during a 5-year period (approximate reoperation rate: 3% in each arm per year). Postoperatively and during 3 years of follow-up, impotence was reported in 17% of the TUVP group and 11% of the TURP group (P = 0.49); retrograde ejaculation was reported in 72% of the TUVP group and 89% of the TURP group (P = 0.47). CONCLUSIONS: Our 5-year follow-up results confirm that TUVP is as effective as standard TURP in the treatment of moderate-size benign prostatic hyperplasia. The reoperation rate and long-term complication rate are comparable and the initial improvement has been maintained during a 5-year period for most patients in both groups.

Adenocarcinoma↗

PubMed1994

Temporal trends in breast cancer surgery in Ontario: can one randomized trial make a difference?

OBJECTIVE: To assess the effect of a single randomized clinical trial, the National Surgical Adjuvant Breast Project (NSABP) B-06, on the surgical management of breast cancer in women. DESIGN: Retrospective cohort study. SETTING: All hospitals in Ontario. PATIENTS: A consecutive sample of 37,447 women with breast cancer newly diagnosed from Jan. 1, 1980, to Dec. 31, 1989, linked to a surgical procedure record in the Ontario Cancer Registry. MAIN OUTCOME MEASURE: The most invasive surgical procedure used within 90 days of diagnosis. RESULTS: Unilateral breast-ablative surgery (BAS) was performed in 57.3% of the women and breast-conserving surgery (BCS) in 31.6%. The annual rate of BAS declined from 77.5% in 1980 to 44.2% in 1989 and the rate of BCS rose from 12.5% in 1980 to 43.5% in 1989. The decline was linear from 1980 to 1984 and then accelerated significantly in 1985 (p < 0.0001), after the results of the NSABP B-06 trial were published. CONCLUSION: One randomized clinical trial can have an immediate and profound effect on medical practice.

Age Distribution↗

PubMedDate not supplied

Prophylactic sclerotherapy in nonalcoholic liver cirrhosis: preliminary results of a prospective controlled randomized trial.

Between June, 1984 and December, 1985, a total of 41 patients were enrolled in a prospective controlled randomized trial comparing prophylactic sclerotherapy and medical treatment for the prevention of the first esophageal variceal bleeding. All patients had nonalcoholic liver cirrhosis, fourth degree varices, and no past history of gastrointestinal bleeding. The patients were randomly assigned to the control group (20 patients) or to the sclerotherapy group (21 patients); most of the patients belonged to Child's classes A and B. After a mean follow-up of 16.8 months, there were 3 variceal bleeding episodes and a 10% mortality rate in the control group whereas neither hemorrhage nor death was observed in the sclerotherapy group. In the latter group, severe complications occurred in 9.5% of the patients; the rate of recurrence after eradication of esophageal varices was 40%. Although there were no statistically significant results, the favorable trend toward a lower bleeding risk and better survival observed in the treated patients suggests that a longer trial in a larger population of cirrhotic patients with a longer follow-up should be considered.

Aged↗

PubMed2006

A prospective, randomized trial evaluating the safety and efficacy of fibrin sealant in tubeless percutaneous nephrolithotomy.

PURPOSE: We performed a prospective, randomized trial to assess the safety and efficacy of fibrin sealant in tubeless percutaneous nephrolithotomy. MATERIALS AND METHODS: A total of 63 patients undergoing tubeless percutaneous nephrolithotomy were randomized to receive Tisseel vapor heated sealant at the end of the procedure. Fibrin sealant was instilled under direct vision in the nephrostomy tract at the end of the procedure. Patients younger than 14 years and those undergoing staged percutaneous nephrolithotomy or bilateral simultaneous percutaneous nephrolithotomy were excluded from study. Patients needing greater than 2 percutaneous tracts, those with significant bleeding or associated pyonephrosis and those with a residual stone burden were also excluded from study. The perioperative outcome in these patients (experimental group) was compared with the outcome in those undergoing tubeless percutaneous nephrolithotomy without fibrin sealant (control group). RESULTS: Fibrin sealant was instilled in 32 patients. There was no difference in the hematocrit decrease and blood transfusion requirement in the 2 groups. Patients in the experimental group experienced less postoperative pain and required less analgesia. They were discharged home 5 hours earlier than patients in the control group. However, this difference was not statistically significant. Complete stone clearance was achieved in 87.5% of patients in the experimental group and in 90.32% of controls. CONCLUSIONS: The instillation of Tisseel fibrin glue is safe for tubeless percutaneous nephrolithotomy. It is associated with less postoperative pain and a lower analgesic requirement. Additional prospective, randomized studies are required to better define its clinical role in the future.

Adult↗

PubMed2001

The revised CONSORT statement for reporting randomized trials: explanation and elaboration.

Overwhelming evidence now indicates that the quality of reporting of randomized, controlled trials (RCTs) is less than optimal. Recent methodologic analyses indicate that inadequate reporting and design are associated with biased estimates of treatment effects. Such systematic error is seriously damaging to RCTs, which boast the elimination of systematic error as their primary hallmark. Systematic error in RCTs reflects poor science, and poor science threatens proper ethical standards. A group of scientists and editors developed the CONSORT (Con solidated S tandards o f R eporting T rials) statement to improve the quality of reporting of RCTs. The statement consists of a checklist and flow diagram that authors can use for reporting an RCT. Many leading medical journals and major international editorial groups have adopted the CONSORT statement. The CONSORT statement facilitates critical appraisal and interpretation of RCTs by providing guidance to authors about how to improve the reporting of their trials. This explanatory and elaboration document is intended to enhance the use, understanding, and dissemination of the CONSORT statement. The meaning and rationale for each checklist item are presented. For most items, at least one published example of good reporting and, where possible, references to relevant empirical studies are provided. Several examples of flow diagrams are included. The CONSORT statement, this explanatory and elaboration document, and the associated Web site ( http://www.consort-statement.org ) should be helpful resources to improve reporting of randomized trials. Throughout the text, terms marked with an asterisk are defined at end of text.

Algorithms↗