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Results for “Randomized controlled trials”

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PubMedDate not supplied

A randomized controlled trial of alternative approaches to community follow-up for postpartum women.

This three-group randomized controlled trial assessed the effectiveness of a postpartum public health nurse telephone visit on infant-care behaviours of primiparous women in Ottawa-Carleton. The impact of a clerk call on recruiting mothers to parent-baby groups was also described. Low risk primiparas were randomized into telephone visit, clerk call and control groups. At three months postpartum, there were no significant differences in infant-care behaviour scores among the study groups. Women who received the telephone visit had the highest parent-baby group attendance rates and among attenders, the highest rates of smoking during pregnancy, the least education, and lowest incomes. Analysis of variance revealed a significant interaction term between attendance at parent-baby groups and assigned study group. This effect disappeared after adjusting for age and education. The telephone visit was no more effective in producing the desired infant-care behaviour changes than a mailed out information package with or without a clerk phone call. However, the intervention did increase the utilization of parent-baby support groups by women who were more socioeconomically disadvantaged.

Attitude to Health↗

PubMed1989

Views of mothers and midwives participating in the Bristol randomized, controlled trial of active management of the third stage of labor.

Mothers and midwives who had participated in the Bristol randomized controlled trial of active versus physiologic management of the Third Stage of Labor were asked for their views. One hundred ninety-one mothers (11% of the total randomized) and 49 midwives completed self-administered questionnaires. Both mothers and midwives commented adversely about the length of the third stage under physiologic management. In general, their views were in accord with the conclusions of the main trial (based on clinical data, including maternal blood loss, length of third stage, need for therapeutic oxytocic agents, and specified neonatal morbidity) in favor of continuing with the current practice of active management.

Attitude of Health Personnel↗

PubMed2006

Cognitive-behavioral intervention to enhance adherence to antiretroviral therapy: a randomized controlled trial (CCTG 578).

OBJECTIVE: We conducted a randomized, multi-site, controlled trial of a cognitive-behavioral adherence intervention for patients initiating or changing an antiretroviral (ART) regimen. DESIGN: A 3 x 2 factorial design was used with the primary randomization assigning patients (1: 1: 1) to one of two adherence interventions or usual care. METHODS: The five-session adherence interventions consisted of cognitive-behavioral and motivational components, with or without a 2-week pre-treatment placebo practice trial. Intent-to-treat analysis used probability weights and regression tree analysis to account for missing data. RESULTS: A total of 230 patients were randomized; 199 started ART, of whom 74% completed the 48-week study. Electronic monitored adherence outcomes between the two intervention groups did not differ significantly and were thus pooled in analyses. At week 4, 82% of intervention patients had taken at least 90% of their prescribed ART doses, compared with 65% of controls (P < 0.01); this group difference dropped to 12% at week 12 (72 versus 60%; P = 0.15) and 11% at week 24 (66 versus 55%; P = 0.28). Mean adherence in the intervention group was significantly higher than the control group at week 24 (89 versus 81%; P < 0.05) only. There were no group differences with respect to HIV-1 RNA throughout the study. CONCLUSIONS: The effects of the cognitive-behavioral intervention on adherence were modest and transient, and no effects were observed on viral load or CD4 cell count. More robust effects may require a more intense intervention that combines ongoing adherence monitoring and individualized intervention "dosage" that matches the need and performance of each patient.

Adult↗

PubMed2002

High-dose tamoxifen in the treatment of inoperable hepatocellular carcinoma: A multicenter randomized controlled trial.

In the Asia-Pacific region and elsewhere, almost 85% of patients with hepatocellular carcinoma (HCC) are inoperable at diagnosis and have a dismal prognosis. Tamoxifen (TMX) is believed to inhibit HCC positive for estrogen receptor (ER), but most HCCs are ER negative. Results of previous phase 3 trials in inoperable HCC have been conflicting and inconclusive. At higher doses, however, TMX inhibits HCC through ER-independent mechanisms. A multicenter randomized controlled trial was performed to assess the role of high-dose TMX versus placebo (P) in the treatment of patients with inoperable HCC with respect to survival and quality of life (QoL). A total of 329 patients from 10 centers in 9 countries in the Asia-Pacific region enrolled in a double-blind randomized controlled trial of TMX 120 mg/d (TMX120) against P as a control arm with an intermediate dosage of TMX 60 mg/d (TMX60) to assess possible dose response. An independent data monitoring committee reviewed all aspects of the trial. QoL was assessed using the European Organization for Research and Treatment of Cancer QLQ-C30 questionnaire. Three-month survival rates for the P, TMX60, and TMX120 groups were 44%, 41%, and 35%, respectively, with a statistically significant trend difference in survival across the 3 treatment regimens (P =.011). There was a significantly higher risk of death in the TMX120 group compared with the P group (hazard ratio, 1.39; 95% confidence interval, 1.07-1.81). Adverse drug reactions were reported in 3% (9 patients), and 8 patients were lost to follow-up. In conclusion, TMX does not prolong survival in patients with inoperable HCC and has an increasingly negative impact with increasing dose. No appreciable advantage to QoL with TMX was observed.

Adolescent↗

PubMedDate not supplied

Prophylactic granulocyte transfusions: results of a randomized controlled trial in patients with acute myelogenous leukemia.

A prospective randomized and controlled clinical trial of prophylactic granulocyte transfusions was conducted in an attempt to reduce the mortality from infection in newly diagnosed adults with acute myelogenous leukemia. Granulocytes were harvested from normal donors by cytapheresis, and transfused patients received a median of 1.45 x 10(10) granulocytes (range 0.28--3.45 x 10(10)) on alternate days during marrow aplasia caused by initial induction chemotherapy. Transfusion were started if the absolute peripheral granulocyte count was less than 500 microliters. Thirteen patients received from one to 12 granulocyte transfusions, and 11 control patients received no granulocytes. No significant advantage was demonstrated in the transfused patients compared with controls with regard to the following: 1) deaths due to infection, 2) reduction in the frequency of febrile episodes, 3) delay in the onset of fever, 4) reduction in the length of febrile episodes, or 5) reduction in the frequency of proven infection.

Adolescent↗

PubMed2006

Five years to the term breech trial: the rise and fall of a randomized controlled trial.

OBJECTIVE: On the basis of the end points of neonatal morbidity and death, the authors of the term breech trial concluded unequivocally that cesarean delivery was safer for breech babies. STUDY DESIGN: Analysis of the original and new data gives rise to serious concerns as far as study design, methods, and conclusions are concerned. In a substantial number of cases, there was a lack of adherence to the inclusion criteria. There was a large interinstitutional variation of standard of care; inadequate methods of antepartum and intrapartum fetal assessment were used, and a large proportion of women were recruited during active labor. In many instances of planned vaginal delivery, there was no attendance of a clinician with adequate expertise. RESULTS: Most cases of neonatal death and morbidity in the term breech trial cannot be attributed to the mode of delivery. Moreover, analysis of outcome after 2 years has shown no difference between vaginal and abdominal deliveries of breech babies. CONCLUSION: The original term breech trial recommendations should be withdrawn.

Breech Presentation↗

PubMed2001

A randomized controlled trial of motivational enhancement therapy (MET) for mild to moderate alcohol dependence.

OBJECTIVE: This study was designed to conduct a randomized controlled trial of motivational enhancement therapy (MET) with two control conditions: nondirective reflective listening (NDRL) and no further counseling (NFC); and to conduct this study in a sample of patients with a primary diagnosis of mild to moderate alcohol dependence, in a "real-life" clinical setting. METHOD: Patients with mild to moderate alcohol dependence were recruited, assessed and treated at the Community Alcohol and Drug Service of Christchurch, New Zealand. All patients received a feedback/education session before randomization to either four sessions of MET, four sessions of NDRL, or NFC. Outcome data on 122 subjects (57.4% men) were obtained 6 months following the end of treatment, by an interviewer who was blind to the treatment condition. The primary drinking outcome was unequivocal heavy drinking, defined as drinking 10 or more standard drinks six or more times in the follow-up period. Global assessment scale (GAS) measured general personal/social functioning. RESULTS: Of patients treated with MET, 42.9% showed unequivocal heavy drinking compared with 62.5% of the NDRL and 65.0% of the NFC groups (p = .04). No significant differences were found for GAS score according to treatment condition. CONCLUSIONS: In patients with mild to moderate alcohol dependence, MET is more effective for reducing unequivocal heavy drinking than either a feedback/education session alone or four sessions of NDRL. MET can be considered an effective "value added" counseling intervention in a real-life clinical setting. In patients with mild to moderate alcohol dependence, nondirective reflective listening provides no additional advantage over a feedback/education session alone.

Adolescent↗

PubMed1988

Amniotomy or oxytocin for induction of labor. Re-analysis of a randomized controlled trial.

A recently reported "prospective, randomized study into amniotomy and oxytocin as induction methods in a total unselected population" was examined for selection bias and bias after entry into the study. The null hypothesis that clinical attitudes to amniotomy as a means for inducing labor had no influence on the decision to enter women into the trial and allocate them to either amniotomy or oxytocin was rejected at p less than 0.00025. Clinical attitudes were further found to statistically significantly influence the prescribed assessments 4 h after entry into the trial and the selection of the second intervention that was required in the absence of acceptable progress (p less than 0.0005). Bias at the time of this prescribed assessment was large enough to result in an inverse relationship between "acceptable progress within 4 hours" and "delivery within 24 hours" after induction. A subanalysis of the nulliparae entered into the trial further substantiated both bias at entry and bias in following the prescribed protocol. As hypothesized, these biases reached a greater statistical significance in nulliparous than in parous women. The likelihood that all of these observations would be encountered in a truly randomized study of this size can be estimated to be less than one in a billion (or p less than 0.000,000,000,000,1). The study, therefore, provides a classical example of the dangers of non-blind allocation to different treatment groups in clinical trials. It is further concluded that no randomized controlled studies between amniotomy and oxytocin in a "total unselected population" are available.

Amnion↗

PubMed2001

Is drug treatment of hypertension in clinical practice as effective as in randomized controlled trials with regard to the reduction of the incidence of stroke?

The results from several nonexperimental studies suggest that drug treatment of hypertension in daily clinical practice may not be as effective as in randomized controlled trials. These nonexperimental studies had limitations with regard to the selection of an appropriate control group. The objective of our study was to assess the effect of drug treatment of hypertension under circumstances of everyday medical practice on the incidence of stroke by using a prognostically comparable untreated reference group. Within two prospective, population-based cohort studies among 45,000 men and women 20 years of age and older in the Netherlands, we selected a cohort of 2,301 hypertensive subjects who either received drug treatment for hypertension (N = 1,318) or were untreated for hypertension but were determined to be "candidates" for drug treatment on the basis of their level of blood pressure and the presence of other cardiovascular risk factors (N = 983). Follow-up averaged 4.6 years and was complete for 91% of the hypertensives. Compared with untreated hypertensive subjects who were "candidates" for drug treatment, subjects who received drug treatment for hypertension had, after adjustment for potential confounders, a 39% [95% confidence interval (CI) = 3-61%] reduced risk of stroke. About 46 (95% CI = 29-599) hypertensive patients need to be treated with antihypertensive drugs for 5 years to prevent one stroke in the general Dutch population. When a prognostically comparable reference group is used, the drug treatment of hypertension under circumstances of everyday medical practice appears to be effective in the reduction of the incidence of stroke. The relative risk reduction that we found was similar to those found in randomized controlled trials.

Aged↗

PubMed2002

Developmental outcome of preterm infants after surfactant therapy: systematic review of randomized controlled trials.

OBJECTIVES: To review neuro-developmental outcome at 1 and 2 years of age following randomized controlled trials (RCT) of neonatal surfactant therapy. METHODS: A systematic review of the MEDLINE, Embase and Cochrane Controlled Trial Register databases, searching for RCT of surfactant replacement therapy with follow-up outcomes, was carried out. The main outcome measures were severe and mild disability at 1 and 2 years plus composite adverse outcome of death and/or severe disability. RESULTS: A meta-analysis using odds ratios was carried out on 13 RCT. There were a total of 2218 treated and 2090 control infants who underwent follow up at 1 year of age. There were 303 treated and 292 control infants with follow up at between 18 months and 2 years of age. Surfactant therapy was associated with a lower rate of mild disability at 1 year (OR 0.79; 95% CI 0.66-0.95). There was a reduction in the combined adverse outcome (death or severe disability rate) at 1 year (OR 0.8; 95% CI 0.72-0.89). Neither the 1 year nor the 2 year follow-up examination showed a statistical difference in the severe disability rate between the control and treated group. CONCLUSION: Surfactant therapy increases survival without an increase in subsequent morbidity at 1 and 2 years of age.

Child, Preschool↗

PubMed2005

Randomized controlled trials of aprotinin in cardiac surgery: could clinical equipoise have stopped the bleeding?

BACKGROUND: Aprotinin is a serine protease inhibitor used to limit perioperative bleeding and reduce the need for donated blood transfusions during cardiac surgery. Randomized controlled trials of aprotinin evaluating its effect on the outcome of perioperative transfusion have been published since 1987, and systematic reviews were conducted in 1992 and 1997. METHODS: A systematic search was conducted for all RCTs of aprotinin that used placebo controls or were open-label with no active control treatment. Data collected included the primary outcome, objective of each study, whether a systematic review was cited or conducted as part of the background and/or rationale for the study and the number of previously published RCTs cited. Cumulative meta-analyses were performed. RESULTS: Sixty-four randomized, controlled trials of aprotinin were found, conducted between 1987 and 2002, reporting an endpoint of perioperative transfusion. Median trial size was 64 subjects, with a range of 20 to 1784. A cumulative meta-analysis indicated that aprotinin greatly decreased the need for perioperative transfusion, stabilizing at an odds ratio of 0.25 (p < 10 - 6) by the 12th study, published in June of 1992. The upper limit of the confidence interval never exceeded 0.65 and results were similar in all subgroups. Citation of previous RCTs was extremely low, with a median of 20% of prior trials cited. Only 7 of 44 (15%) of subsequent reports referenced the largest trial (N = 1784), which was 28 times larger than the median trial size. CONCLUSIONS: This study demonstrates that investigators evaluating aprotinin were not adequately citing previous research, resulting in a large number of RCTs being conducted to address efficacy questions that prior trials had already definitively answered. Institutional review boards and journals could reduce the number of redundant trials by requiring investigators to conduct adequate searches for prior evidence and conducting systematic reviews.

Aprotinin↗

PubMed2026

Effectiveness of a Web-Based Educational eHealth Platform on Women's Health Literacy About Phthalate Exposure: Randomized Controlled Trial.

BACKGROUND: Phthalates are environmental endocrine-disrupting chemicals widely used in plastics, cosmetics, food packaging, and personal care products. Women may experience frequent exposure through everyday consumer and household products. Improving phthalate-related health literacy may support informed exposure-reduction decisions; however, conventional health education provides limited opportunities for repeated, interactive, and individually tailored learning. OBJECTIVE: This randomized controlled trial evaluated the effectiveness of an eHealth educational intervention (Phthalates Free) in improving women's overall and domain-specific phthalate-related health literacy and examined the association between platform engagement and health literacy outcomes. METHODS: A double-blind randomized controlled trial was conducted in the outpatient department of a regional teaching hospital in Taipei, Taiwan. A total of 114 women were randomly assigned to an intervention group (n=58) receiving a 6-month eHealth platform-based education program and a control group (n=56) receiving conventional paper-based education. Assessments were conducted at baseline (T0), 3 months (T1), and 6 months (T2). The Phthalate Health Literacy Scale (10 items; α=.90, content validity index=0.93) measured overall and domain-specific literacy (health care, disease prevention, and health promotion). Longitudinal outcomes were analyzed using generalized estimating equations based on all available observations according to participants' original randomized assignments, with adjustment for waist circumference and pregnancy history. Analysis of covariance (ANCOVA) was used to compare 6-month outcomes after adjustment for baseline scores. Platform engagement and perceived usability were assessed using back-end analytics and the System Usability Scale (SUS). RESULTS: At 6 months, the intervention group showed a significantly greater increase in total health literacy than the control group (+9.93 points, Wald χ²1=17.74; P<.001). Domain analyses revealed significant improvements in health care (+1.52; P=.001), disease prevention (+1.32; P=.001), and health promotion (+1.12; P=.001) domains. ANCOVA confirmed the between-group difference at T2 after adjusting for baseline scores (F1,109=11.43; P=.001; adjusted mean difference=7.15, 95% CI 2.96-11.34). Engagement analysis showed that high-engagement users (n=10) scored significantly higher in overall health literacy (t55=-3.00; P=.004) and all domains than general users. The SUS results (mean 84.7, SD 5.2; n=46, 79.3%) indicated high perceived usability. CONCLUSIONS: The Phthalates Free eHealth educational intervention significantly improved women's overall and domain-specific health literacy over 6 months. Higher platform engagement was associated with better health literacy outcomes. The intervention may serve as a practical adjunct to nurse-led education in outpatient and community settings by providing accessible, continuous, and evidence-based guidance on reducing phthalate exposure.

Humans↗

PubMed2006

Stapled vs open hemorrhoidectomy: long-term outcome of a randomized controlled trial.

BACKGROUND AND AIMS: Stapled hemorrhoidectomy is a relatively new procedure, and studies on long-term outcomes are few. We present the results of a 5-year follow-up on patients recruited to a randomized controlled trial comparing stapled and Milligan-Morgan hemorrhoidectomy. PATIENTS AND METHODS: We performed telephone interviews and office visits between May and July 2005 on patients who had taken part in a randomized controlled trial from May 1999 to December 2000. RESULTS: Occasional pain and bleeding were referred by the patients with no difference between the two groups. The patients were also equally satisfied with both procedures. No recurrent hemorrhoidal prolapse or stenosis was detected at anorectal exploration and rigid sigmoidoscopy. CONCLUSION: Both stapled and Milligan-Morgan techniques guarantee satisfactory long-term results. Larger studies are needed to assess the durability of stapled hemorrhoidectomy.

Follow-Up Studies↗

PubMed1988

A randomized controlled trial of the effect on blood pressure of dietary non-meat protein versus meat protein in normotensive omnivores.

1. A randomized, controlled trial was carried out to examine whether changes in type and amount of dietary protein were responsible for earlier observations of blood-pressure-lowering effects of lacto-ovo-vegetarian diets. 2. Sixty-four subjects were pair-matched for sex, age, weight and sitting systolic blood pressure, and were randomly allocated to receive one of two types of protein supplement: one containing proteins from meat, the other proteins from non-meat sources. The supplements were balanced in terms of other nutrients. Consumption of other meat, poultry or fish was prohibited. 3. Sitting and standing blood pressures, weight, dietary intakes and plasma and urinary electrolytes were measured at regular intervals during the 12 weeks of trial. Urinary 3-methylhistidine was used as a measure of compliance. 4. Fifty subjects completed the trial. There were no statistically significant blood pressure differences between groups either at baseline or at end-of-trial, neither were there any substantive differences in mean blood pressure changes between baseline and end-of-trial. 3-Methyl-histidine excretion was significantly lower in subjects on the non-meat diet. 5. The results suggest that the protein components of the lacto-ovo-vegetarian diet are not responsible for the blood-pressure-lowering effects of that diet.

Adolescent↗

PubMed1993

A randomized controlled trial in a hospital population of ultrasound measurement screening for the small for dates baby.

Poor fetal growth is an important cause of perinatal mortality and morbidity. Based on the hypothesis that early diagnosis of fetal growth problems leads to more appropriate management and therefore, improved outcome, a randomized controlled trial of ultrasound measurement was performed on 1,528 women booked through a hospital antenatal clinic. This compared a number of perinatal outcomes between the group who had a routine 2-stage examination (early dating and 34-week scan) and a group who had only a dating scan and then additional scans as generated by their clinical situations. No significant differences could be found between the groups when these perinatal outcomes were considered. These results mirror previously published randomized controlled trials. Selection of women for third trimester ultrasound examination for suspected fetal growth problems should be based on careful clinical assessment and should not be routine.

Birth Weight↗

PubMed1992

The impact of clinical pharmacists' consultations on physicians' geriatric drug prescribing. A randomized controlled trial.

The impact of clinical pharmacists' consultations on geriatric drug prescribing was studied in a prospective randomized controlled trial of patients 65 years of age and over discharged on 3 or more medications for chronic conditions from a 450-bed community hospital. The pharmacists provided consultation to experimental patients and their physicians at hospital discharge and at periodic intervals for 3 months postdischarge. Using a standardized tool, a physician-pharmacist panel, blinded to study group assignment of patients, evaluated the appropriateness of prescribing for a random sample of 236 patients. Eighty-eight percent had at least one or more clinically significant drug problems, and 22% had at least one potentially serious and life-threatening problem. Drug-therapy problems were divided into six categories: 1) inappropriate choice of therapy; 2) dosage; 3) schedule; 4) drug-drug interactions; 5) therapeutic duplication; and 6) allergy. Experimental patients were less likely to have one or more prescribing problems in any of the categories (P = 0.05) or in the appropriateness (P = 0.02) or dosage (P = 0.05) categories. A summary score, measuring the appropriateness of the patient's total drug regimen, indicated that experimental patients' regimens were more appropriate than those of controls (P = 0.01). Results of this trial reveal that clinical pharmacists can improve the appropriateness of geriatric drug prescribing in outpatient settings.

Aged↗

PubMed2006

The effect of alpha-adrenergic antagonists in chronic prostatitis/chronic pelvic pain syndrome: a meta-analysis of randomized controlled trials.

The effectiveness of alpha-adrenergic antagonists on patients with chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) has not been supported by well-evaluated study. The meta-analysis was performed to supply the best evidence about use of this class of drugs in CP/CPPS. A fully recursive literature search to June 2005 was conducted in PubMed, EMBASE, the Cochrane Controlled Trials Register, and the Chinese Biomedicine Database to identify potentially relevant randomized controlled trials. RevMan4.2 was used for statistical analysis. Nine studies with 734 patients were included. Combined analysis showed a significant reduction of total NIH-CPSI or I-PSS in patients with treatment duration of more than 3 months. There were also valuable results in urinary symptom alleviation. Alpha-adrenergic antagonists did not show benefit in pain. The meta-analysis revealed that the use of alpha-adrenergic antagonists was warranted in CP/CPPS, and the treatment duration should be long enough (more than 3 months).

Adrenergic alpha-Antagonists↗

PubMed1991

Treatment of fulminant hepatic failure with insulin and glucagon. A randomized, controlled trial.

Insulin and glucagon are among the therapeutic modalities that have been investigated in the treatment of fulminant hepatic failure (FHF). We have completed a randomized, controlled trial of insulin and glucagon in 38 patients with FHF from either viral or toxin exposure. The control and treatment groups consisted of 21 and 17 patients, respectively, and did not differ significantly in etiology or admission laboratory values. Mortality was not significantly different between control and treatment groups and was 67% and 82%, respectively. Time from randomization to death or discharge was not significantly different between the two groups. Peak levels of alpha-fetoprotein were statistically higher in survivors than in nonsurvivors (P less than 0.01). We conclude that even though a type-2 error may exist, the combination of insulin and glucagon is not useful in the treatment of FHF.

Adult↗