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Results for “Randomized controlled trials”

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PubMed2006

Effects of self-management intervention on health outcomes of patients with heart failure: a systematic review of randomized controlled trials.

BACKGROUND: Heart failure is the most common cause of hospitalization among adults over 65. Over 60% of patients die within 10 years of first onset of symptoms. The objective of this study is to determine the effectiveness of self-management interventions on hospital readmission rates, mortality, and health-related quality of life in patients diagnosed with heart failure. METHODS: The study is a systematic review of randomized controlled trials. The following data sources were used: MEDLINE (1966-11/2005), EMBASE (1980-11/2005), CINAHL (1982-11/2005), the ACP Journal Club database (to 11/2005), the Cochrane Central Trial Registry and the Cochrane Database of Systematic Reviews (to 11/2005); article reference lists; and experts in the field. We included randomized controlled trials of self-management interventions that enrolled patients 18 years of age or older who were diagnosed with heart failure. The primary outcomes of interest were all-cause hospital readmissions, hospital readmissions due to heart failure, and mortality. Secondary outcomes were compliance with treatment and quality of life scores. Three reviewers independently assessed the quality of each study and abstracted the results. For each included study, we computed the pooled odds ratios (OR) for all-cause hospital readmission, hospital readmission due to heart failure, and death. We used a fixed effects model to quantitatively synthesize results. We were not able to pool effects on health-related quality of life and measures of compliance with treatment, but we summarized the findings from the relevant studies. We also summarized the reported cost savings. RESULTS: From 671 citations that were identified, 6 randomized trials with 857 patients were included in the review. Self-management decreased all-cause hospital readmissions (OR 0.59; 95% confidence interval (CI) 0.44 to 0.80, P = 0.001) and heart failure readmissions (OR 0.44; 95% CI 0.27 to 0.71, P = 0.001). The effect on mortality was not significant (OR = 0.93; 95% CI 0.57 to 1.51, P = 0.76). Adherence to prescribed medical advice improved, but there was no significant difference in functional capabilities, symptom status and quality of life. The reported savings ranged from 1300 to 7515 dollars per patient per year. CONCLUSION: Self-management programs targeted for patients with heart failure decrease overall hospital readmissions and readmissions for heart failure.

Health Status↗

PubMed1996

A randomized controlled trial of the cost-effectiveness of a district co-ordinating service for terminally ill cancer patients.

The objective of this paper is to compare the cost effectiveness of a co-ordination service with standard services for terminally ill cancer patients with a prognosis of less than one year. We designed a randomized controlled trial, with patients randomized by the general practice with which they were registered. Co-ordination group patients received the assistance of two nurse coordinators whose role was to ensure that patients had access to appropriate services. The setting was in a South London health authority. Complete service use and outcome data were collected on 167 patients, 86 in the co-ordination group, and 81 in the control group. Our results, as previously reported, show that no differences in outcomes were detected between the co-ordination and control groups; the mean total costs incurred by the co-ordination group were significantly less than those of the control group. The co-ordinated group used significantly fewer inpatient days (mean 24 versus 40 inpatient days; t = 2.4, p = 0.002) and nurse home visits (mean 14.5 versus 37.5 visits; t = 0.3, p = 0.01). Mean cost per co-ordinated patient was almost half that of the control group patients 4774 pounds versus 8034 pounds, t = 2.8, p = 0.006). Although the unit cost data were relatively crude, these cost reductions were insensitive to a wide range of unit costs. These differences persisted when, in order to control for any putative differences in severity between the two groups, the analysis was restricted to patients who had died by the end of the study. The ratio of potential cost savings to the cost of co-ordination service was between 4:1 and 8:1. In conclusion, the co-ordination service for cancer patients who were terminally ill with a prognosis of less than one year was more cost effective than standard services, due to achieving the same outcomes at lower service use, particularly inpatient days in acute hospital. Assuming that the observed effects are real, improved co-ordination of palliative care offers the potential for considerable savings. Further research is needed to explore this issue.

Adolescent↗

PubMed2001

Perinatal depression: a randomized controlled trial of an antenatal education intervention for primiparas.

BACKGROUND: Depression can be an unexpected and distressing companion for a woman during the major life transition of becoming a mother for the first time. Researchers now demonstrate that approximately 50 percent of women will experience perinatal distress. Therefore, the etiology and management of perinatal depression is essential for a quality care of childbearing women. The objectives of this study were to develop an education intervention tailored to the information needs of primiparous women about perinatal depression, to deliver this intervention antenatally, and to conduct a randomized controlled trial to determine the effect of the antenatal education intervention in the reduction of postnatal depression. METHOD: A prospective, randomized controlled trial of the education intervention (n = 206) was conducted at three sites in Australia. The outcome of changes in mood state was measured by the Profile of Mood States questionnaire once antenatally (12-28 wk), and twice postnatally (8-12 and 16-24 wk); social support and demographic data were also collected. The education package was administered to the intervention group at the antenatal assessment of mood. RESULTS: A significant and steady reduction in scores (overall and on the subscales) was observed over time for both groups that showed significant improvement in symptoms of depression. No difference was detected when comparing the intervention group with the control group. Additional multivariate regression analyses revealed no relevant influence of social support or demographic variables. CONCLUSIONS: Women in both the study and control groups were more depressed antenatally than postnatally. The finding that the education intervention made no difference challenges the two strongly held tenets of health education in childbearing women-that depression can be reduced through education and that antenatal education interventions can endure into the postnatal period.

Adult↗

PubMed2003

Efficacy of exercise counselling as an aid for smoking cessation: a randomized controlled trial.

AIM: To examine whether exercise counselling increases smoking abstinence and reduces tobacco withdrawal and gains in weight and body fat. DESIGN: A randomized controlled trial. SETTING: A community-based stop smoking clinic. PARTICIPANTS: Two hundred and ninety-nine male and female smokers. INTERVENTION: Participants were assigned randomly to a 7-week smoking cessation programme, including nicotine replacement therapy plus either (i) exercise counselling, or (ii) health education advice with equal contact time as for the exercise counselling condition. MEASUREMENTS: Six weeks of smoking abstinence was confirmed by expired carbon monoxide. FINDINGS: There was no significant difference in smoking abstinence between the exercise group (n = 154) and the controls (n = 145) at 6 weeks (39.6% versus 38.6%), nor was there any difference in gains in weight or body fat, although those in the exercise group increased their exercise levels. Exercise participants reported less tension, anxiety and stress than the controls during the first week of smoking abstinence (P = 0.03, 0.01 and 0.04, respectively), less irritability throughout 2 weeks of abstinence (P = 0.03), and less restlessness throughout 3 weeks of abstinence (P = 0.04). CONCLUSIONS: Adding brief exercise counselling to a smoking cessation programme did not increase smoking abstinence or reduce gains in weight or body fat significantly, although exercise levels were raised and there were some beneficial effects on psychological symptoms.

Adult↗

PubMed2005

Spinal cord stimulation electrode design: a prospective, randomized, controlled trial comparing percutaneous with laminectomy electrodes: part II-clinical outcomes.

OBJECTIVE: Spinal cord stimulation, in use for more than 30 years, has evolved into an easily implemented technique involving percutaneous or laminectomy electrode placement. In a randomized comparison of four-contact percutaneous and four-contact insulated laminectomy electrodes placed at the same level in the dorsal, epidural midline, quantitative measures of stimulator performance revealed significant technical advantages for the laminectomy electrodes. Our prospective, randomized, controlled trial compares clinical results in these same patients. METHODS: Impartial third parties followed our series of 24 patients with failed back surgery syndrome to gather clinical outcome data. We defined "success" as at least 50% sustained relief of pain and patient satisfaction with the result of treatment. RESULTS: At a mean follow-up of 1.9 years, 10 of 12 patients receiving the laminectomy electrode and 5 of 12 patients receiving the percutaneous electrode reported a successful outcome (P < 0.05). Follow-up at a mean of 2.9 years showed that this result was maintained in 5 of 12 patients with the laminectomy electrode and 3 of 12 with the percutaneous electrode (not statistically significant). Many patients reported improvements in most activities of daily living, and loss of function was rare. In addition, 9 patients with laminectomy electrodes and 4 with percutaneous electrodes reducted or eliminated analgesic intake (P < 0.05), and 2 returned to work. No electrode migration was observed. CONCLUSION: Laminectomy electrode placement, although more invasive than percutaneous placement, yields significantly better clinical results in patients with failed back surgery syndrome at mean 1.9 years follow-up. In our small sample, however, the statistical significance of this advantage disappeared at mean 2.9 years follow-up.

Adult↗

PubMed2006

Comparison of a technique using a new percutaneous osteosynthesis device with conventional open surgery for displaced patella fractures in a randomized controlled trial.

OBJECTIVE: To compare the percutaneous patellar osteosynthesis system (PPOS) technique with open surgery for patella fractures. DESIGN: Randomized controlled trial. SETTING: Referral orthopedic and trauma center. PATIENTS: Fifty-three patients with displaced patellar fractures. INTERVENTION: Stabilization and fixation of patellar fractures with PPOS or open surgery. MAIN OUTCOME MEASUREMENTS: Knee-flexion and -extension angles, pain, surgical time, and assessment of knee function based on the Knee Society Clinical Rating Scale (KSCRS). RESULTS: Comparison of PPOS and open-surgery groups at 4 weeks showed the following: pain, 3.7 +/- 1.6 versus 6.2 +/- 1.4 arbitrary units, P < 0.001; flexion angle, 46 +/- 20.7 versus 12.7 +/- 6.0 degrees, P < 0.001; extension angle, -2.5 versus -3.8 degrees, P < 0.001. At 8 weeks, the following was demonstrated: pain, 1.3 +/- 1.6 versus 4.1 +/- 2.1 arbitrary units, P < 0.001; flexion angle, 87 +/- 17.3 versus 34 +/- 26 degrees, P < 0.001; extension angle, 0 versus -3 degrees, P < 0.001. Surgical time was 35.3 +/- 7.8 versus 66.2 +/- 14.1 minutes, P < 0.001. KSCRS assessment was 84 +/- 4 versus 70 +/- 8, P < 0.001 at 8 weeks; 85 +/- 2 versus 73 +/- 8, P < 0.001 at 12 months; and 85 +/- 1 versus 82 +/- 7, P = 0.246 at 24 months. Frequency of total complications (infections, fragment displacement, and wire-related pain) was significantly lower in the PPOS than in the open-surgery group (P < 0.02). CONCLUSIONS: PPOS for patella fractures was associated with shorter surgical time, less pain, better mobility angles, higher functional score up to 2 years, and a lower incidence of complications than open surgery.

Adolescent↗

PubMed2002

A randomized controlled trial of resistance exercise training to improve glycemic control in older adults with type 2 diabetes.

OBJECTIVE: To determine the efficacy of high-intensity progressive resistance training (PRT) on glycemic control in older adults with type 2 diabetes. RESEARCH DESIGN AND METHODS: We performed a 16-week randomized controlled trial in 62 Latino older adults (40 women and 22 men; mean +/- SE age 66 +/- 8 years) with type 2 diabetes randomly assigned to supervised PRT or a control group. Glycemic control, metabolic syndrome abnormalities, body composition, and muscle glycogen stores were determined before and after the intervention. RESULTS: Sixteen weeks of PRT (three times per week) resulted in reduced plasma glycosylated hemoglobin levels (from 8.7 +/- 0.3 to 7.6 +/- 0.2%), increased muscle glycogen stores (from 60.3 +/- 3.9 to 79.1 +/- 5.0 mmol glucose/kg muscle), and reduced the dose of prescribed diabetes medication in 72% of exercisers compared with the control group, P = 0.004-0.05. Control subjects showed no change in glycosylated hemoglobin, a reduction in muscle glycogen (from 61.4 +/- 7.7 to 47.2 +/- 6.7 mmol glucose/kg muscle), and a 42% increase in diabetes medications. PRT subjects versus control subjects also increased lean mass (+1.2 +/- 0.2 vs. -0.1 +/- 0.1 kg), reduced systolic blood pressure (-9.7 +/- 1.6 vs. +7.7 +/- 1.9 mmHg), and decreased trunk fat mass (-0.7 +/- 0.1 vs. +0.8 +/- 0.1 kg; P = 0.01-0.05). CONCLUSIONS: PRT as an adjunct to standard of care is feasible and effective in improving glycemic control and some of the abnormalities associated with the metabolic syndrome among high-risk older adults with type 2 diabetes.

Aged↗

PubMed2005

[Gastric lavage in healthy term newborns: a randomized controlled trial].

INTRODUCTION: Gastric lavage is still used in Mexico and other countries without evidence to support this practice. We performed a randomized controlled trial to test the hypothesis that elimination of amniotic fluid from the stomach of the newborn reduces nausea and vomiting and improves tolerance on the first feedings of breast or formula milk. PATIENTS AND METHODS: A randomized, single-blind, controlled trial was conducted in a rural general hospital in the north of Mexico. Eligible healthy term newborns were randomly allocated to receive gastric lavage (n = 63) or observation (n = 61). The primary outcome measures were the presence of nausea and/or emesis in the first 24 hours of life and the breastfeeding failure rate, evaluated by a nurse blinded to the group assignment. RESULTS: Of the 63 patients in the gastric lavage group, 13 had at least one episode of nausea or vomiting compared with 15 out of 61 patients in the control group (relative risk: 0.84; 95 % CI: 0.43 to 1.61). Breastfeeding failure occurred in seven mother-child pairs in the gastric lavage group compared with five in the control group (P = 0.8; relative risk: 0.96; 95 % CI: 0.86 to 1.08). Other variables such as sex or cesarian section rate were unrelated to outcome. There were no complications that could be attributed to the procedure. All the newborn infants were discharged without problems. CONCLUSIONS: Gastric aspiration or lavage in the healthy full-term newborn is a common procedure that should be abandoned as it confers no advantages.

Breast Feeding↗

PubMed2003

Acupressure and quality of sleep in patients with end-stage renal disease--a randomized controlled trial.

The purpose of the study is to test the effectiveness of acupressure on sleep quality of end-stage renal disease patients. The study was a randomized controlled trial; qualified patients in the dialysis centers of four major hospitals were randomly assigned into an acupressure group, a sham acupressure group, and a control group. A total of 98 participants were included in the study. The main outcomes measured were the Pittsburgh sleep quality index (PSQI) and the sleep log. Data were collected at pretreatment and following treatment. Primary statistical analysis was by means of Analysis of Covariance, the Kruskal-Wallis Test and repeated measure ANOVA. The results indicated that PSQI scores of the acupressure group have a significantly greater improvement (p < 0.01) than the control group. However, there were no differences between the acupressure group and the sham group or the sham group and the control group (p > 0.05). Subscales of PSQI were further analyzed. Results demonstrated significant differences between the acupressure group and the control group in subjective sleep quality (p = 0.009), sleep duration (p = 0.004), habitual sleep efficiency (p = 0.001), and sleep sufficiency (p = 0.004). Significant differences in the subscale of subjective sleep quality (p = 0.003) between the sham acupressure group and the control group were also observed. Sleep log data showed that the acupressure group significantly decreased awake time and improved quality of sleep over time more than the control group (p < 0.01). The improvement could be seen as soon as the acupoints massage was implemented, and it was maintained through the post intervention.

Acupressure↗

PubMed2003

Nutritional interventions during pregnancy for the prevention or treatment of maternal morbidity and preterm delivery: an overview of randomized controlled trials.

This overview assesses the effectiveness of nutritional interventions to prevent or treat maternal morbidity, mortality and preterm delivery. Cochrane systematic reviews and other up-to-date systematic reviews and individual randomized controlled trials were sought. Searches were carried out up to July 2002. Iron and folate supplements reduce anemia and should be included in antenatal care programs. Calcium supplementation to women at high risk of hypertension during pregnancy or low calcium intake reduced the incidence of both preeclampsia and hypertension. Fish oil and vitamins E and C are promising for preventing preeclampsia and preterm delivery and need further testing. Vitamin A and beta-carotene reduced maternal mortality in a large trial; ongoing trials should provide further evaluation. No specific nutrient supplementation was identified for reducing preterm delivery. Nutritional advice, magnesium, fish oil and zinc supplementation appear promising and should be tested alone or together in methodologically sound randomized controlled trials. Anema in pregnancy can be prevented and treated effectively. Considering the multifactorial etiology of the other conditions evaluated, it is unlikely that any specific nutrient on its own, blanket interventions or magic bullets will prevent or treat preeclampsia, hemorrhage, obstructed labor, infections, preterm delivery or death during pregnancy. The few promising interventions for specific outcomes should be tested or reconsidered when results of ongoing trials become available. Until then, women and their families should receive support to improve their diets as a general health rule, which is a basic human right.

Clinical Trials as Topic↗

PubMed2006

Effect of vitamin C on common cold: randomized controlled trial.

OBJECTIVE: To investigate the relationship between the common cold and vitamin C supplementation. DESIGN: A double-blind, 5-year randomized controlled trial. SETTING: A village in Akita prefecture, one of the regions in Japan with the highest mortality from gastric cancer. SUBJECTS: Participants in annual screening programs for circulatory diseases conducted under the National Health and Welfare Services Law for the Aged, and diagnosed as having atrophic gastritis. Of the 439 eligible subjects, 144 and 161 were assigned to receive 50 or 500 mg of vitamin C, respectively, after protocol amendment. During the supplementation phase, 61 dropped out, and 244 completed the trial. INTERVENTION: Daily vitamin C supplementation of 50 mg (low-dose group) or 500 mg (high-dose group). RESULTS: Total number of common colds (per 1000 person-months) was 21.3 and 17.1 for the low- and high-dose groups, respectively. After adjustment for several factors, the relative risks (95% confidence interval (CI)) of suffering from a common cold three or more times during the survey period was 0.34 (0.12-0.97) for the high-dose group. No apparent reduction was seen for the severity and duration of the common cold. CONCLUSION: A randomized, controlled 5-year trial suggests that vitamin C supplementation significantly reduces the frequency of the common cold but had no apparent effect on the duration or severity of the common cold. However, considering several limitations due to protocol amendment, the findings should be interpreted with caution.

Adult↗

PubMed2004

Effects of intravenous prostaglandin E1 on arterial compliance: a randomized controlled trial.

BACKGROUND: Prostanoids are in widespread use for the treatment of critical limb ischemia and are suggested to improve arterial compliance. However, dose- and time-dependency of these drug effects are indeterminate. We investigated the influence of intravenous application of prostanoids on arterial compliance parameters in patients with critical limb ischemia due to peripheral artery disease (PAD). PATIENTS AND METHODS: We included 82 consecutive patients with PAD Fontaine stage III and IV in a patient-blinded, randomized controlled trial. Patients were randomly assigned to either single dose intravenous treatment with 40 microg (n = 29) or 60 microg (n = 27) of Alprostadil (PGE1) in 250 ml 0.9% saline over 2 hours, or 250 ml 0.9% saline solution as a placebo group (n = 26). Large and small artery compliance was measured by peripheral pulse contour analysis at baseline, at one hour during intravenous infusion of Alprostadil, immediately after and 24 hours after the end of the infusion. For study purposes the patients received Alprostadil only once during the observation period of 2 days. RESULTS: Large artery compliance, blood pressure, heart rate and cardiac output were unaffected by PGE1 administration irrespectively of drug-dosage or time interval. Small artery compliance increased at 1 hour during intravenous application of Alprostadil (40 microg Alprostadil p = 0.001; 60 microg Alprostadil p < 0.0001) compared to placebo and increased median +47% (IQR +5% to +100%) after administration of 40 microg Alprostadil and median +32% (IQR -11% to +88%) after 60 microg Alprostadil (p = 0.5). Immediately after the end of Alprostadil infusion small artery compliance decreased to baseline levels. CONCLUSIONS: Prostaglandin E1 causes a significant improvement of small artery compliance during the time of intravenous application. However, this effect rapidly diminishes after the end of administration and no dose-dependency between 40 microg and 60 microg Alprostadil is observed.

Adaptation, Physiological↗

PubMed2004

Reliance on visual information after stroke. Part II: Effectiveness of a balance rehabilitation program with visual cue deprivation after stroke: a randomized controlled trial.

OBJECTIVE: To test the hypothesis that balance rehabilitation with visual cue deprivation improves balance more effectively than rehabilitation with free vision. DESIGN: Single-blind, randomized controlled trial. SETTING: Public rehabilitation center in France. PARTICIPANTS: Twenty patients with hemiplegia after a single-hemisphere stroke that occurred at least 12 months before the study. INTERVENTION: Patients were randomly assigned to 1 of 2 balance rehabilitation programs-with and without visual cue deprivation. In all other respects, the programs were identical. Each lasted for 1 hour and was implemented 5 days a week for 4 weeks. All patients completed the program. Mean outcome measures Balance under 6 sensory conditions was assessed by computerized dynamic posturography (EquiTest), gait velocity, timed stair climbing, and self-assessment of ease of gait before and after program completion. RESULTS: After completing the program, balance, gait velocity, and self-assessment of gait improved significantly in all patients. The improvements in gait velocity (P= .03) and timed stair climbing (P= .01) correlated significantly with improved balance. Balance improved more in the vision-deprived group than in the free-vision group. CONCLUSIONS: Balance improved more after rehabilitation with visual deprivation than with free vision. Visual overuse may be a compensatory strategy for coping with initial imbalance exacerbated by traditional rehabilitation.

Cues↗

PubMed2005

A cognitive behavioral group approach to enhance adherence to hemodialysis fluid restrictions: a randomized controlled trial.

BACKGROUND: Adhering to fluid restrictions represents one of the most difficult aspects of the hemodialysis treatment regimen. This report describes a randomized controlled trial of a group-based cognitive behavioral intervention aimed at improving fluid-restriction adherence in patients receiving hemodialysis. It was hypothesized that the intervention would improve adherence, measured by means of interdialytic weight gain (IWG), without impacting negatively on psychosocial functioning. METHODS: Fifty-six participants receiving hemodialysis from 4 renal outpatient settings were randomly assigned to an immediate-treatment group (ITG; n = 29) or deferred-treatment group (DTG; n = 27). Participants were assessed at baseline, posttreatment, and follow-up stages. Treatment consisted of a 4-week intervention using educational, cognitive, and behavioral strategies to enhance effective self-management of fluid consumption. RESULTS: No significant difference in mean IWGs was found between the ITG and DTG during the acute-phase analysis (F(1,54) = 0.03; P > 0.05). However, in longitudinal analysis, there was a significant main effect for mean IWG (F(1.76,96.80) = 9.10; P < 0.001) and a significant difference between baseline and follow-up IWG values (t55 = 3.85; P < 0.001), reflecting improved adherence over time. No adverse effects of treatment were indicated through measures of psychosocial functioning. Some significant changes were evidenced in cognitions thought to be important in mediating behavioral change. CONCLUSION: The current study provides evidence for the feasibility and effectiveness of applying group-based cognitive behavior therapy to enhance adherence to hemodialysis fluid restrictions. Results are discussed in the context of the study's methodological limitations.

Adult↗

PubMed2005

Effect of resistance training on resting blood pressure: a meta-analysis of randomized controlled trials.

OBJECTIVE: To assess the influence of resistance training on resting blood pressure in healthy sedentary adults. METHODS: A comprehensive literature search with the MEDLINE computerized database was conducted and reference lists of published articles and reviews on the topic were checked. Inclusion criteria were as follows: the study involved a randomized, controlled trial; resistance training was the sole intervention; participants were sedentary normotensive and/or hypertensive adults with no other concomitant disease; the article was published in a peer-reviewed journal up to December 2003. We identified nine randomized controlled trials, involving 12 study groups and 341 participants. A standard protocol was used to extract information on sample size, participant characteristics, study design, training method and duration, and study outcomes. Pooled blood pressure estimates were obtained, weighted by either the number of participants in the training group or the inverse of the variance for blood pressure change. RESULTS: The weighted net changes of blood pressure, after adjustment for control observations, averaged -3.2 [95% confidence limits (CL) -7.1 to +0.7]/-3.5 (95% CL -6.1 to -0.9) mmHg when weighted for the number of trained participants, and -6.0 (95% CL -10.4 to -1.6)/ -4.7 (95% CL -8.1 to -1.4) mmHg, when weighted by the reciprocal of the variance for the blood pressure change. CONCLUSIONS: Our results suggest that moderate intensity resistance training is not contraindicated and could become part of the non-pharmacological intervention strategy to prevent and combat high blood pressure. However, additional studies are needed, especially in the hypertensive population.

Adult↗

PubMed2001

Maternal satisfaction with active management of labor: a randomized controlled trial.

BACKGROUND: Active management of labor reduces the length of labor and rate of prolonged labor, but its effect on satisfaction with care, within a randomized controlled trial, has not previously been reported. The study objectives were to establish if a policy of active management of labor affected any aspect of maternal satisfaction, and to determine the independent explanatory variables for satisfaction with labor care in a low-risk nulliparous obstetric population. METHODS: Nulliparous women at National Women's Hospital in Auckland, New Zealand, in spontaneous labor at term with singleton pregnancy, cephalic presentation, and without fetal distress were randomized after the onset of labor to active management (n = 320) or routine care (n = 331). Active management included early amniotomy, two-hourly vaginal assessments, and early use of high dose oxytocin for slow progress in labor. Routine care was not prespecified. Maternal satisfaction with labor care was assessed by postal questionnaire at 6 weeks postpartum. Sensitivity analyses were performed, and logistic regression models were developed to determine independent explanatory variables for satisfaction. RESULTS: Of the 651 women randomized in the trial, 482 (74%) returned the questionnaires. Satisfaction with labor care was high (77%) and did not significantly differ by treatment group. This finding was stable when sensitivity analysis was performed. The first logistic regression model found independent associations between satisfaction and adequate pain relief, one-to-one midwifery care, adequate information and explanations by staff, accurate expectation of length of labor, not having a postpartum hemorrhage, and fewer than three vaginal examinations during labor. The second model found fewer than three vaginal examinations and one-to-one midwifery care as significant explanatory variables for satisfaction with labor care. CONCLUSIONS: Active management did not adversely affect women's satisfaction with labor and delivery care in this trial. Future studies should concentrate on measurement of potential predictors before and during labor.

Adult↗

PubMed2001

Are the results of randomized controlled trials on anticoagulation in patients with atrial fibrillation generalizable to clinical practice?

BACKGROUND: Randomized trials demonstrate a clear benefit of anticoagulation in patients with atrial fibrillation at risk of stroke, but the proportion of eligible patients who are treated with anticoagulants remains low. The reluctance to treat all eligible patients with anticoagulants may be due to studies in clinical practice showing variable risk-benefit, raising concerns about application to general medical practice. METHODS: A systematic review of published medical literature was performed to identify studies of patients with atrial fibrillation who were treated with warfarin in actual clinical practice. Data from these studies were compared with pooled data from randomized controlled trials. RESULTS: Three studies met the predefined criteria, each in a different health care setting, totaling 410 patients with 842 patient-years of follow-up. Patients in clinical practice were older and had more comorbid conditions compared with trial participants. However, the ischemic stroke rate was similar between clinical practice and randomized studies (1.8% [95% confidence interval (CI), 0.9%-2.7%] vs 1.4% [95% CI, 0.9%-2.0%]). Intracranial hemorrhage (0.1% [95% CI, 0%-0.3%] vs 0.3% [95% CI, 0.06%-0.5%]) and major bleeding (1.1% [95% CI, 0.4%-1.8%] vs 1.3% [95% CI, 0.8%-1.8%]) rates were also similar. There was a higher rate of minor bleeding in clinical practice than in trials (12.0% [95% CI, 9.7%-14.3%] vs 7.9% [95% CI, 6.6%-9.2%]). CONCLUSIONS: Patients who undergo anticoagulation for atrial fibrillation in actual clinical practice differ from those in randomized trials, but have similar rates of stroke and major bleeding. The risk of minor bleeding is higher and may require more intensive monitoring in practice.

Aged↗

PubMed2005

Are randomized controlled trials (RCTs) redundant for testing the efficacy of homeopathy? A critique of RCT methodology based on entanglement theory.

INTRODUCTION: Randomized controlled trials (RCTs) have yet to deliver unequivocal results demonstrating the efficacy (or otherwise) of homeopathic remedies and individualized homeopathic prescribing. This could be caused by an implicit assumption inherent in RCT methodology that specific effects of a remedy and any nonspecific effects of consultation are independent of each other. Reported here is a theoretical investigation of the consequences arising from this assumption proving to be false. METHODS: A previously developed theoretical model of entanglement in homeopathy between patient, practitioner, and remedy (called PPR entanglement) was used in this investigation. RESULTS: The adherence to RCT methodology could result in such trials completely disrupting the formation or survival of any three-way PPR entangled state. CONCLUSIONS: Assuming the PPR entangled state is a necessary condition for therapeutic interaction, alternatives to RCTs are urgently required that can take into account possible entangled specific and nonspecific effects during trials of homeopathy. That RCTs sometimes deliver positive results for the use of homeopathic remedies may be caused by residual entanglement arising from homeopathic remedy manufacture.

Homeopathy↗