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At least 577 records · Page 32Linked to original sources
PubMed2001

Helping patients decide about back surgery: a randomized trial of an interactive video program.

STUDY DESIGN: A randomized trial of 100 patients with low back pain who were potential surgical candidates. OBJECTIVES: To determine whether an interactive videodisc with a booklet is superior to a booklet alone for informing patients about back surgery. SUMMARY OF BACKGROUND DATA: Substantial geographic variation has been observed in lumbar spine surgery. Informed patient preferences should play an important role in decisions about surgery. However, little is known about optimal strategies for informing patients. METHODS: Subjects were randomized to receive an interactive videodisc (with a booklet) or a booklet alone. A knowledge test administered at baseline and follow-up was used to measure improvement in knowledge about treatment options for lumbar spine problems. Patients' reactions to the videodisc and booklet and preferences for treatment were also assessed. RESULTS: The patients' knowledge improved after exposure to either intervention. Multivariate analyses adjusted for baseline score, age, education, gender, and diagnosis showed a significant advantage for the videodisc with booklet over the booklet alone. The videodisc-booklet group showed significantly greater gains in knowledge among subjects with the worst baseline knowledge scores. A larger proportion of subjects in the videodisc-booklet group rated the materials easy to understand (93% vs.- 72%,P = 0.04), containing the right amount of information (93% vs.- 80%,P = 0.3), and adequate to assist in choice of treatment (75% vs.- 51%,P = 0.2). Those who viewed the videodisc expressed a somewhat lower preference for surgery than those who received the booklet alone (23% vs.- 42%,P = 0.4). CONCLUSIONS: Both the booklet alone and the combination of videodisc and booklet improved knowledge. The combination produced greater knowledge gains than the booklet alone for the subgroup with the least knowledge at baseline. Patients preferred the combination and had a slightly lower preference for surgery if they had viewed the video presentation. For some patients, the video may enhance involvement in clinical decisions.

Adult↗
PubMed1993

Effect of all transretinoic acid in newly diagnosed acute promyelocytic leukemia. Results of a multicenter randomized trial. European APL 91 Group.

We designed a multicenter randomized trial comparing chemotherapy with daunorubicin-Ara C (chemotherapy group) and all transretinoic acid (ATRA) combined to the same chemotherapy (ATRA group) in newly diagnosed APL patients aged 65 years or less. The major endpoint of the study was event-free survival (EFS) ("events" being defined as failure to achieve complete remission [CR], occurrence of relapse, or death in CR). Early termination of the trial was decided after the first interim analysis, as EFS was significantly higher in the ATRA group. At the time, 101 patients had been randomized (54 in the ATRA group and 47 in the chemotherapy group). In the ATRA group, 49 (91%) patients achieved CR, 5 (9%) had early death, and 0 had resistant leukemia, compared with 38 (81%), 4 (8%), and 5 (10%) patients, respectively, in the chemotherapy group. The difference in CR rate between the two groups was not significant. The duration of coagulopathy was significantly reduced in the ATRA group, compared with the chemotherapy group. In the ATRA group, six patients relapsed after 7 to 15.5 months. In the chemotherapy group, 12 patients relapsed after 1 to 16 months, and 2 died in CR. Kaplan-Meier EFS was estimated at 79% +/- 7% and 50% +/- 9% at 12 months, respectively, in the ATRA and the chemotherapy group (P = .001). Kaplan-Meier estimate of relapse was 19% +/- 8% and 40% +/- 12% at 12 months (P = .005). In conclusion, ATRA followed by chemotherapy increases EFS in newly diagnosed APL. These results strongly suggest that ATRA should be incorporated in the front line therapy of newly diagnosed APL.

Adolescent↗
PubMed1985

The coronary artery surgery study (CASS)--a randomized trial and a registry.

In 1973 the National Heart Lung and Blood Institute organized the Coronary Artery Surgery Study (CASS) including a patient registry and a randomized trial designed to compare medical and surgical therapy in patients with coronary artery disease. This study is discussed in detail and compared with two further large randomized trials of coronary artery bypass surgery, the US Veterans Administration Trial (VA) and the European Cooperative Surgical Study (ECSS). Although there are many differences between these three studies, their similarities warrant some conclusions on the improvement of survival in certain high risk patients, protection against myocardial infarction, the deterioration of graft patency, and the postponement of surgery in low risk patients.

Adrenergic beta-Antagonists↗
PubMed1996

Combined postoperative radiotherapy and weekly cisplatin infusion for locally advanced head and neck carcinoma: final report of a randomized trial.

PURPOSE: To report the final results of a prospective randomized trial that aimed to evaluate efficacy and toxicity of concomitant postoperative radiotherapy and Cisplatin infusion in patients with Stage III or IV squamous cell carcinoma of the head and neck and histological evidence of extracapsular spread of tumor in lymph node metastase(s). METHODS AND MATERIALS: Radiotherapy was delivered using a daily dose of 1.7 Gy for the first 54 Gy and 1.8 to 2 Gy until the completion of the treatment. Cisplatin 50 mg i.v. with forced hydratation was given or not every week (i.e., seven to nine cycles) concurrently with radiotherapy. A total of 44 patients were treated by irradiation only (RT group) and 39 by irradiation with chemotherapy (CM group). RESULTS: The RT group displayed a higher rate of loco-regional failures as compared to CM group (41 vs. 23%; p = 0.08). The overall survival, the survival corrected for deaths by intercurrent disease, and the disease-free survival were better in CM group as compared to RT group with statistically significant differences. Survival without loco-regional treatment failure was better in the CM group, the difference being close to the level of significance (p = 0.05). Survival without distant metastases were comparable in the two therapeutic groups. Ten severe late complications were observed, four in the RT group (17%) and six in the CM group (22%). Cox univariate analysis confirmed the importance of the therapeutic modality in predicting the overall survival, the survival corrected for deaths by intercurrent disease, and the disease-free survival. CONCLUSIONS: The present final report of this phase III study confirms preliminary results. The concomitant use of 50 mg weekly Cisplatin infusion and postoperative radiation improved loco-regional control and survival. No significant increase of late radiation complications was observed in the CM group.

Antineoplastic Agents↗
PubMed1998

A randomized trial comparing Arglaes (a transparent dressing containing silver ions) to Tegaderm (a transparent polyurethane dressing) for dressing peripheral arterial catheters and central vascular catheters.

The purpose of this trial was to prepare for a large randomized trial comparing Arglaes film dressing, a recent innovation containing silver ions, against Tegaderm, a transparent polyurethane dressing. Thirty-one patients admitted to the intensive care unit and requiring the insertion of an arterial line or central venous catheter were recruited into the study. Skin swabs were taken from the insertion sites prior to catheterization and on removal of the intravascular device to measure skin colonization rate between the two dressings. The catheter tips were also cultured on removal to establish if there was a difference between the two groups. No statistical differences were found in bacterial growth between the two dressings.

Adolescent↗
PubMed1998

Influence of airway management on ventilator-associated pneumonia: evidence from randomized trials.

OBJECTIVE: Ventilator-associated pneumonia (VAP) is a serious complication of critical illness, conferring increased morbidity and mortality. Many interventions have been studied to reduce the risk of VAP. We systematically reviewed the influence of airway management on VAP in critically ill patients. DATA SOURCES: Studies were identified through searching MEDLINE and EMBASE from 1980 through July 1997 and by searching SCISEARCH, the Cochrane Library, bibliographies of primary and review articles, personal files, and contact with authors of the randomized trials. STUDY SELECTION: We selected randomized trials evaluating ventilator circuit and secretion management strategies on the rate of VAP. DATA EXTRACTION: Two investigators independently abstracted key data on design features, the population, intervention, and outcome of the studies. DATA SYNTHESIS: The frequency of ventilator circuit changes and the type of endotracheal suction system do not appear to influence VAP rates (3 trials, none with significant difference; range of relative risks [RRs], 0.84-0.91). However, lower VAP rates may be associated with avoidance of heated humidifiers and use of heat and moisture exchangers (5 trials, only 1 showing a significant difference; range of RRs, 0.34-0.86), use of oral vs nasal intubation (1 trial; RR, 0.52; 95% confidence interval, 0.24-1.13), subglottic secretion drainage vs standard endotracheal tubes (2 trials, 1 showing a significant difference; range of RRs, 0.46-0.57), and kinetic vs conventional beds (5 trials, only 1 showing a significant difference; range of RRs, 0.35-0.78). CONCLUSIONS: Some ventilator circuit and secretion management strategies may influence VAP rates in critically ill patients. Whether these strategies are adopted in practice depends on several factors such as the magnitude and precision of estimates of benefit and harm, as well as access, availability, and costs.

Critical Illness↗
PubMed1994

Clinically useful measures of effect in binary analyses of randomized trials.

The results of a randomized clinical trial can be reported using relative and/or absolute estimators of treatment effect. These various measures convey different information, and the choice can influence the physician's appreciation of the size of treatment effect and, subsequently, treatment decisions. We compare the estimators with respect to the clinically relevant information conveyed to physicians, and identify which clinical questions can and cannot be answered directly by each. We also identify opportunities for misinterpretation when one estimator is substituted for another, or when an estimator is mislabeled. Clinically important questions are addressed most directly by reporting both relative and absolute effects using relative risk and its complement, relative risk reduction, and risk difference and its reciprocal, number needed to treat. This is true of estimates of treatment effect derived from a single trial and also from meta-analysis of a group of trials. Because the control group's risk affects the numerical value of the odds ratio, the odds ratio cannot substitute for the risk ratio in conveying clinically important information to physicians. This is especially important when large treatment effects are shown in trials carried out in populations at high baseline risk.

Humans↗
PubMed1989

A randomized trial of continuous intravenous versus hepatic intraarterial floxuridine in patients with colorectal cancer metastatic to the liver: the Northern California Oncology Group trial.

In 1983, the Northern California Oncology Group (NCOG) instituted a randomized trial of intravenous (IV) versus intraarterial (IA) floxuridine (FUDR) administered via an implantable pump for patients with colorectal cancer metastatic to the liver. The study objectives were to compare the hepatic response rate, time to hepatic progression, and toxicity for the two treatment arms. The study design, which allowed patients failing IV FUDR to crossover to the IA arm, prevents a meaningful comparative analysis of survival. Patients with liver-only metastases (N = 143) were randomized, 76 to the IV arm and 67 to the IA arm, and 115 patients (65 IV, 50 IA) were fully evaluable. Of the 65 patients in the IV arm, 28 crossed over to IA treatment after failing IV FUDR. The dose-limiting toxicity of IV FUDR was diarrhea, whereas biliary toxicity limited both the dose and duration of IA FUDR therapy. Of the first 25 patients treated with IA FUDR at a dose of .3 mg/kg/day, 10 developed radiographically evident biliary strictures, and three developed permanent jaundice. With reduction of the initial IA FUDR dose to .2 mg/kg/day, and adoption of a policy of early dosage reduction, treatment interruption, or termination of therapy for persistent elevations in alkaline phosphatase, only two further cases of serious biliary toxicity occurred. However, 26 of the 50 IA FUDR patients ultimately had therapy terminated because of drug toxicity rather than disease progression. When compared with systemic infusion, infusion into the hepatic artery greatly enhanced the antitumor activity of FUDR against colorectal liver metastases. Although biliary toxicity is the most serious limitation of this form of therapy, biliary stricture and jaundice usually can be averted through careful monitoring of liver enzymes and early dosage reduction.

Adult↗
PubMed2005

Premedication with orally administered midazolam in adults undergoing diagnostic upper endoscopy: a double-blind placebo-controlled randomized trial.

BACKGROUND: A double-blind placebo-controlled randomized trial was conducted to investigate the safety and the efficacy of orally administered midazolam as premedication for patients undergoing elective EGD. METHODS: A total of 130 patients were randomized to receive either 7.5 mg of midazolam orally (n = 65) or a placebo (n = 65) as premedication. Outcomes measures included the anxiety score (visual analog scale) during EGD, overall tolerance, extent of amnesia, overall satisfaction, patient willingness to repeat the procedure, recovery time, and hemodynamic changes after medication. RESULTS: The median (interquartile range) anxiety score during the procedure in the midazolam group was significantly lower than that in the control group (2.0 [0-4.9] vs. 3.8 [2.1-7.95], p < 0.001). A significantly greater number of patients in the midazolam group graded overall tolerance as "excellent or good" (70.8% vs. 49.2%, p = 0.012) and reported a partial to complete amnesia response (52.3% vs. 32.3%, p = 0.02) when compared with the control group. Patients in the midazolam group were more willing to repeat the procedure if necessary (89.2% vs. 69.2%, p = 0.005). The median (interquartile range) recovery time was significantly longer in the midazolam group than in the control group (5 [5-15] minutes vs. 5 [5-10] minutes, p = 0.014). There were no statistically significant differences in satisfaction score and hemodynamic changes between groups. CONCLUSIONS: Premedication by oral administration of midazolam is a safe and an effective method of sedation that significantly reduces anxiety and improves overall tolerance for patients undergoing EGD.

Administration, Oral↗
PubMed1979

A prospective randomized trial of vagotomy in chronic duodenal ulceration.

In a prospective, randomized trial, 76 patients with duodenal ulceration treated by truncal vagotomy and pyloroplasty were compared with 77 patients who underwent highly selective vagotomy. A total of 149 patients was followed up for from 1 to 4 years, the average follow-up period being 2.6 years. There was no operative mortality and no significant difference in postoperative morbidity between the two groups. The incidence of recurrent ulceration was greater after highly selective vagotomy, but this difference was not statistically significant. The clinical results were comparable in each group, and although the incidence of diarrhoea and dumping was greater after vagotomy and pyloroplasty, this difference was not statistically significant.

Adult↗
PubMed2001

Accounting for correlation and compliance in cluster randomized trials.

This paper discusses causal inference with survival data from cluster randomized trials. It is argued that cluster randomization carries the potential for post-randomization exposures which involve differentially selective compliance between treatment arms, even for an all or nothing exposure at the individual level. Structural models can be employed to account for post-randomization exposures, but should not ignore clustering. We show how marginal modelling and random effects models allow to adapt structural estimators to account for clustering. Our findings are illustrated with data from a vitamin A trial for the prevention of infant mortality in the rural plains of Nepal.

Cluster Analysis↗
PubMed2003

Conducting randomized trials in the electrophysiology laboratory: lessons from a randomized comparison of recording methods during pulmonary vein isolation by segmental ostial ablation.

Accurate identification of pulmonary vein (PV) potentials during segmental ostial ablation for PV isolation is very important to completely isolate the PVs and also to avoid unnecessary applications of radiofrequency energy. A prior post hoc analysis of unipolar and bipolar electrograms recorded from successful and unsuccessful ablation sites demonstrated that unipolar electrograms recorded at successful sites were more likely to have a rapid intrinsic deflection, larger amplitude, and earlier activation than electrograms recorded at unsuccessful sites. Moreover, unipolar electrograms recorded from the ablation and circular ostial mapping catheters were almost identical at successful sites. Based on these observations, a prospective, randomized study was conducted to test whether unipolar and bipolar electrograms would facilitate the ablation procedure when compared to bipolar electrograms alone during PV isolation in patients with atrial fibrillation (AF). In 44 consecutive patients with paroxysmal AF, 114 PVs were randomized to segmental ostial ablation guided by unipolar and bipolar electrograms (61) or by bipolar electrograms only (53). Segmental ostial ablation guided by unipolar and bipolar electrograms was associated with a approximately 20-30% decrease in the procedure and fluoroscopy times necessary for isolation of a PV and also in the duration of radiofrequency energy application required for complete isolation of a PV. Although the sample size was not sufficient to detect a 5% change, the success rate for complete electrical isolation and the risk of symptomatic PV stenosis were similar between the 2 groups. Online analysis of unipolar electrograms facilitated the PV isolation procedure and was incremental to the analysis of bipolar electrograms alone. However, because segmental ostial ablation has only modest efficacy in achieving long-term freedom from recurrent AF, alternative ablation strategies that may or may not target PVs will eventually evolve. The role of unipolar electrograms in these new methods remains to be determined.

Action Potentials↗
PubMed1996

Factors affecting sample selection in a randomized trial of balance enhancement: the FICSIT Study.

OBJECTIVE: To determine demographic, functional, and health-related factors that may have influenced the selection of older adults for a randomized trial of balance enhancement. DESIGN: Comparison of participants with nonparticipants at various stages of the recruiting process. SETTING: Northeastern suburban community. PARTICIPANTS: Registered voters aged 75 and older (n = 7191). MEASUREMENTS: Demographic, health-related, functional, balance, gait, and falling characteristics. RESULTS: The overall participation rate in the randomized trial was 1.5%. Compared with nonparticipants, participants were significantly more likely to be male, married, living with others, living in a house, highly educated, healthy, and physically active. CONCLUSION: Recruiting older subjects by mail to studies of rigorous interventions can produce significant selection biases that may limit the population to which results can be generalized.

Accidental Falls↗
PubMed1988

A clinician's guide for conducting randomized trials in individual patients.

In determining optimal treatment for a patient conventional trials of therapy are susceptible to bias. Large-scale randomized trials can provide only a partial guide and have not been or cannot be carried out for most clinical disorders. However, randomized controlled trials (RCTs) in individual patients (N of 1 RCTs) may in some circumstances provide a solution to this dilemma. In an N of 1 RCT a patient undergoes pairs of treatment periods (one period of each pair with the active drug and one with matched placebo, assigned at random); both the patient and the clinician are blind to allocation, and treatment targets are monitored. N of 1 RCTs are useful for chronic, stable conditions for which the proposed treatment, which has a rapid onset of action and ceases to act soon after it is discontinued, has shown promise in an open trial of therapy. The monitoring of treatment targets usually includes quantitative measurement of the patient's symptoms with the use of simple patient diaries or questionnaires. Pairs of treatment periods are continued until effectiveness is proved or refuted. The cooperation of a pharmacy is required for the preparation of matching placebos and conduct of the trial. Formal statistical analysis may be helpful for interpreting the results. The practical approach presented in this paper allows clinicians to conduct their own N of 1 RCTs.

Clinical Trials as Topic↗
PubMed2004

Intravenous iron optimizes the response to recombinant human erythropoietin in cancer patients with chemotherapy-related anemia: a multicenter, open-label, randomized trial.

PURPOSE: Recombinant human erythropoietin (rHuEPO) is the standard of care for patients with chemotherapy-related anemia. Intravenous (IV) iron improves hemoglobin (Hb) response and decreases dosage requirements in patients with anemia of kidney disease, but its effect has not been studied in randomized trials in cancer patients. METHODS: This prospective, multicenter, open-label, randomized trial enrolled 157 patients with chemotherapy-related anemia (Hb <or= 105 g/L, serum ferritin <or= 450 pmol/L or <or= 675 pmol/L with transferrin saturation <or= 19%) receiving subcutaneously rHuEPO 40000 U once weekly to: (1). no-iron; (2). oral iron 325 mg twice daily; (3) iron dextran repeated 100mg IV bolus; or (4) iron dextran total dose infusion (TDI). Hb and quality of life (QOL) were measured at baseline and throughout. RESULTS: All groups showed Hb (P <.0001) increases from baseline. Mean Hb increases for both IV iron groups were greater (P <.02) than for no-iron and oral iron groups. The percentage of patients with hematopoietic responses was higher (P <.01) in both IV iron groups (each case 68%) compared with no-iron (25%) and oral iron (36%) groups. IV iron groups showed increases in energy, activity, and overall QOL from baseline, compared with a decrease in energy and activity for no-iron group and no change in activity or overall QOL for oral iron group. CONCLUSION: rHuEPO increases Hb levels and improves QOL in patients with chemotherapy-related anemia. Magnitude of Hb increase and QOL improvement is significantly greater if IV iron is added.

Abnormalities, Drug-Induced↗
PubMed2002

Five-year follow-up of patients participating in a randomized trial of uterine balloon therapy versus rollerball ablation for treatment of menorrhagia.

STUDY OBJECTIVE: To collect long-term follow-up information from women who participated in a randomized trial comparing uterine balloon therapy (UBT; Gynecare, Somerville, NJ) with rollerball ablation for treatment of menorrhagia. DESIGN: Five-year contact of participants treated in a 1996 multicenter, randomized trial (Canadian Task Force classification I). SETTING: Twelve North American university and private practice centers. PATIENTS: Women treated with endometrial ablation for menorrhagia who were available for 5-year follow-up. INTERVENTION: Uterine balloon therapy or rollerball ablation. MEASUREMENTS AND MAIN RESULTS: Of 255 women treated under the original protocol, 147 were available to be interviewed 5 years after the procedure. Of these, 25 patients reported hysterectomy, repeat ablation, or dilatation and curettage (D&C) between years 3 and 5, leaving 122 eligible for analysis (61 UBT, 61 rollerball). Of these 122 patients, 58 (95%) having UBT and 59 (97%) having rollerball ablation reported normal or less bleeding. Similarly, 93% and 100%, respectively, were satisfied with the procedure. Among the total population of 255 women, 42 hysterectomies (21 UBT, 21 rollerball), 5 repeat ablations (3 UBT, 2 rollerball), and 1 D&C (rollerball) were reported by year 5. Thirty-five hysterectomies (83%) were performed because of bleeding and/or pelvic pain; one-third of them were associated with myomas. Nearly 7 of 10 women were cured of menorrhagia without additional intervention 5 years after ablation. CONCLUSION: UBT continues to be an effective, simple treatment of menorrhagia, with clinical outcomes similar to those of rollerball ablation at 5-year follow-up.

Adult↗