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Results for “Randomized controlled trials”

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PubMed2006

Women's evaluations of their experience in a multicenter randomized controlled trial of intrapartum fetal pulse oximetry (The FOREMOST Trial).

BACKGROUND: Fetal pulse oximetry improves the assessment of fetal well-being during labor. The objective of this study was to evaluate women's satisfaction with their experience with this additional technology. METHODS: We surveyed women participating in the FOREMOST trial, a randomized controlled trial comparing the addition of fetal pulse oximetry (FPO) to conventional cardiotocograph (CTG) monitoring (intervention group), versus CTG-only (control group), in the presence of nonreassuring fetal status during labor. Our survey evaluated 3 aspects of women's experience: labor, fetal monitoring, and participation in the research. The survey was administered within a few days of giving birth and repeated 3 months later. RESULTS: No differences were found between the intervention and control groups for women's evaluations of their labor, fetal monitoring, research, or overall experiences when surveyed on both occasions. Within each study group, a small but statistically significant decline occurred in women's scores for their experience of labor and overall experience from the initial survey close to the time of giving birth, to 3 months later. The magnitude of differences in responses over time was similar for the both groups. Women were more satisfied after a spontaneous or assisted vaginal birth than after cesarean section. Length of time the research midwife was present had a significant positive effect on women's ratings of their experience several days after giving birth (p = 0.006), but no effect at 3 months. CONCLUSIONS: The addition of fetal pulse oximetry for the assessment of fetal well-being during labor did not affect childbearing women's perceptions of fetal monitoring or their labor. Women evaluated their experience in the research process positively overall. Small changes occurred in women's perception of their satisfaction over time.

Adult↗
PubMed1990

Intravenous recombinant tissue-type plasminogen activator in patients with unstable angina pectoris. Results of a placebo-controlled, randomized trial.

Because thrombus formation may contribute to coronary obstruction in patients with unstable angina pectoris, we performed a pilot investigation to determine whether thrombolytic therapy can relieve coronary narrowing in this acute ischemic syndrome. Sixty-seven patients with rest angina and angiographic evidence of coronary stenosis were randomly assigned to receive either low-dose intravenous recombinant tissue-type plasminogen activator (rt-PA) (0.75 mg/kg over 1 hour), high-dose intravenous rt-PA (0.75 mg/kg over 1 hour; total dose, 100 mg over 6 hours), or intravenous placebo followed by repeat coronary angiography at 24-48 hours to assess change in the severity of coronary narrowing. Each patient also received oral aspirin and intravenous heparin. Mean values of coronary stenosis severity (percent of diameter reduction) declined to a similar extent in each group: placebo, 75 +/- 14% to 72 +/- 14% (p = 0.07); low-dose rt-PA, 75 +/- 16% to 71 +/- 18% (p = 0.03), and high-dose rt-PA, 82 +/- 11% to 77 +/- 17% (p = 0.18), with only the low-dose rt-PA group achieving statistical significance. Resolution of intracoronary filling defects, increase in antegrade flow grade, or both also occurred equally among the three groups. There was considerable variation in individual patient response. Between 29% and 50% of patients within each group demonstrated a decrease in stenosis severity, whereas 50% to 57% noted either improvement in antegrade flow or resolution of intracoronary thrombus. There was no difference in incidence of major bleeding events among the three groups.(ABSTRACT TRUNCATED AT 250 WORDS)

Aged↗
PubMedDate not supplied

Factors affecting patient recruitment in an acute rehabilitation randomized controlled trial.

OBJECTIVE: To evaluate factors associated with randomized controlled trial patient recruitment by therapists. METHOD: Survey of 18 (of a possible 26) therapists who had agreed to recruit patients for a randomized controlled trial (78% response rate). RESULTS: Sixteen respondents had enrolled at least one patient. The site at which the therapist worked neither influenced the likelihood that a therapist would contact the researcher nor influenced the recruitment rate. Seventeen respondents reported that they contacted the researcher to discuss one or more of their patients for potential inclusion in the trial. Factors reported by therapists as reasons why they did not recommend the trial to eligible patients were not specific to study inclusion or exclusion criteria, rather were linked to personal judgments about patient suitability for the study. Regression analysis indicated that being enrolled or having completed master's level postgraduate studies, and choosing not to refer patients because of concern for their poor medical prognosis were the only factors that significantly influenced recruitment rate (p < 0.001). CONCLUSION: Recruitment practices vary amongst therapists. Selection of therapists with postgraduate qualifications as recruiters may be an effective way to enhance recruitment rate.

Attitude of Health Personnel↗
PubMed1989

Quality assessment of randomized controlled trials of contrast media.

Numerous randomized controlled trials (RCTs) have been conducted to define the relative benefits of low-osmolality contrast media (LOM) and high-osmolality contrast media (HOM). Because of the clinical and economic significance of the conclusions drawn from these RCTs, the authors used a standardized instrument to evaluate the quality of study design and data analysis of 100 RCTs published between 1982 and 1987 that compared LOM and HOM. The mean quality score (+/- standard deviation) was 39 +/- 12 (maximum possible score, 100). The largest number of patients studied in any RCT was 435; the smallest was five. A majority of the RCTs received high scores on three attributes of quality, intermediate scores on seven, and low scores on nine. These results underscore the difficulty of designing, performing, analyzing, and reporting high-quality RCTs. Nevertheless, limitations in study design and data analysis need to be considered when interpreting results of these RCTs. Future RCTs comparing LOM and HOM should be performed with greater attention to basic elements of good study design and data analysis.

Clinical Trials as Topic↗
PubMedDate not supplied

The development of a register of randomized controlled trials in prehospital trauma care.

OBJECTIVES: To establish a register of randomized controlled trials of interventions in the prehospital care of trauma patients. METHODS: A systematic search was conducted for all randomized controlled trials of interventions in the prehospital care of trauma patients. The search included the Cochrane Controlled Trial Register, the Cochrane Injuries Group Specialised Register, Medline, EMBASE, the Cumulative Index to Nursing & Allied Health Literature (CINAHL), Science Citation Index, National Research Register, Dissertation Abstracts, and PubMed for the time period 1966-2000. There were no language restrictions. In addition, full-text hand searching of a range of relevant journals was done, and the authors of included trials were contacted. RESULTS: The combined search strategy identified 16,037 potentially eligible records, of which 28 were reports of randomized controlled trials evaluating prehospital trauma care interventions. After excluding duplicate reports, there were 24 separate randomized controlled trials including 6,806 patients. The largest and smallest trials involved 1,309 and 30 trauma patients, respectively. CONCLUSIONS: This register will facilitate the conduct of systematic reviews of the effectiveness of interventions in prehospital trauma care. However, despite the extensive searching, very few randomized trials in this area were found. In view of the absence of evidence for the effectiveness of many of the interventions that are used in the prehospital care of trauma patients, further randomized controlled trials are required.

Emergency Medical Services↗
PubMed2000

Lack of effect of supplementation with essential fatty acids on bone mineral density in healthy pre- and postmenopausal women: two randomized controlled trials of Efacal v. calcium alone.

Randomized controlled trials of the effects of the dietary supplement Efacal (Scotia Pharmaceuticals Plc, Guildford, Surrey, UK) v. Ca only on total body bone mineral density (BMD) and markers of bone turnover were conducted in healthy pre- and postmenopausal women separately. Total daily dose for 12 months for the Efacal groups was: Ca 1.0 g, evening primrose oil 4.0 g and marine fish oil 440 mg; and for the control groups was: Ca 1.0 g. Reported compliance was better than 90% in both age groups. For the forty-three premenopausal women (age range 25-40 years), initial mean total body BMD values were similar for Efacal and control groups and both groups showed highly significant mean increases of about 1%; however, there were no significant between-group differences for the changes in BMD or markers of bone turnover. For the forty-two postmenopausal women (age range 50-65 years), initial mean total body BMD values were again well-matched across treatment groups. Both Efacal and control groups showed highly significant decreases in total body BMD of about 1%, but again there were no significant between-group differences in total body BMD or markers of bone turnover. Possible confounding variables such as initial total body BMD were explored but had no effect on the outcome in either age group. Nail quality improved in both age groups and in both Efacal and control groups. Again, there was no significant difference between treatment groups. No evidence was found to support a beneficial effect of Efacal on BMD in these women.

Adult↗
PubMed1997

Promoting screening mammography in inner-city settings. The sustained effectiveness of computerized reminders in a randomized controlled trial.

OBJECTIVES: The authors conducted a randomized controlled trial to evaluate the sustained effectiveness of a computerized reminder system in promoting mammography during a second year of continuing intervention at three primary care practices of a Health Department and a health maintenance organization in Detroit, Michigan. METHODS: Out-of-pocket mammography cost was eliminated for all participants (limited intervention). Computer-generated reminders promoting physician referral for mammography were placed in the medical records of women due for mammography 1 month in advance of their due date (full intervention). RESULTS: Among 1,225 year 2 visitors, mammography rates were 44% for full intervention versus 28% for limited intervention at the health department (adjusted odds ratio [OR] for effect of full intervention 1.84; 95% confidence interval [CI]: 1.40-2.40) and 45% for full versus 46% for limited at the health maintenance organization (adjusted OR 1.06; 95% CI 0.80-1.42). These second year results contrasted with those observed for year 1, during which a significant effect of full intervention was demonstrated for both organizations. After controlling for patient characteristics and site, the effect sizes of full intervention were reduced significantly in the second year compared with the first year (P = 0.05). CONCLUSIONS: The effect of computerized mammography reminders can be sustained in a second year of continued intervention, but individual practice sites and organizations vary in their responsiveness to the intervention. Strategies to promote periodic and repetitive procedure use must identify and address time-varying barriers to their effectiveness.

Adult↗
PubMed2003

Effect of alendronate and exercise on bone and physical performance of postmenopausal women: a randomized controlled trial.

In this randomized, double-blind, placebo-controlled 12-month trial we evaluated effects of weight- bearing jumping exercise and oral alendronate, alone or in combination, on the mass and structure of bone, risk factors for falling (muscle strength and power, postural sway, and dynamic balance), and cardiorespiratory fitness in postmenopausal women. A total of 164 healthy, sedentary, early postmenopausal women were randomly assigned to one of four experimental groups: (1) 5 mg of alendronate daily plus progressive jumping exercise, (2) 5 mg alendronate, (3) placebo plus progressive jumping exercise, or (4) placebo. The primary endpoint was 12-month change in bone mass and geometry (measured with dual-energy X-ray absorptiometry and peripheral computed tomography at several axial and limb sites) and physical performance; the secondary endpoint was change in biochemical markers of bone turnover. The jumping exercise was conducted an average 1.6 +/- 0.9 (mean +/- SD) times a week. Alendronate daily was effective in increasing bone mass at the lumbar spine (alendronate vs placebo 3.5%; 95% CI, 2.2-4.9%) and femoral neck (1.3%; 95% CI, 0.2-2.4%) but did not affect other bone sites. Exercise alone had no effect on bone mass at the lumbar spine or femoral neck; it had neither an additive nor an interactive effect with alendronate at these bone sites. However, at the distal tibia the mean increase of 3.6% (0.3-7.1%) in the section modulus (that is, bone strength) and 3.7% (0.1-7.3%) increase in the ratio of cortical bone to total bone area were statistically significant in the exercise group compared to the nonexercise group, indicating exercise-induced thickening of the bone cortex. Bone turnover was reduced in alendronate groups only. Alendronate had no effect on physical performance while the jumping exercise improved leg extensor power, dynamic balance, and cardiorespiratory fitness. As conclusion Alendronate is effective in increasing bone mass at the lumbar spine and femoral neck, while exercise is effective in increasing the mechanical properties of bone at some of the most loaded bone sites, as well as improving the participants' muscular performance and dynamic balance. Together alendronate and exercise may effectively decrease the risk of osteoporotic fractures.

Alendronate↗
PubMed1999

Effects of female relative support in labor: a randomized controlled trial.

BACKGROUND: This study was a randomized controlled trial of primigravidas in Botswana to determine the effectiveness of the presence of a female relative as a labor companion on labor outcomes. METHODS: One hundred and nine primigravidas in uncomplicated spontaneous labor were randomly distributed into a control group who labored without family members present, and an experimental group who had a female relative with them during labor. RESULTS: Significantly more mothers in the experimental group had a spontaneous vaginal delivery (91% vs 71%), less intrapartum analgesia (53% vs 73%), less oxytocin (13% vs 30%), fewer amniotomies to augment labor (30% vs 54%), fewer vacuum extractions (4% vs 16%), and fewer cesarean sections (6% vs 13%) than in the control group. These differences were all significant at p < 0.05. Epidural analgesia was not used in the hospital at the time of the study. The only analgesics used were intramuscular pethidine or hyoscine N-butylbromide (Buscopan). CONCLUSIONS: The presence in labor of a female relative was shown to be associated with fewer interventions and a higher frequency of normal delivery compared with the outcomes of those without family member support. The presence of a female relative as a labor companion is a low-cost, preventative intervention that is consistent with the traditional cultural practices in Botswana. In the light of this and previous studies, all women giving birth in a hospital should be offered the choice of a female relative as a companion to give support during labor.

Adult↗
PubMed2004

Prevention of central venous line-related thrombosis by continuous infusion of low-dose unfractionated heparin, in patients with haemato-oncological disease. A randomized controlled trial.

We have conducted a prospective randomized controlled trial to evaluate the role of low-dose unfractionated heparin prophylaxis in preventing central venous line-related thrombosis in patients with haemato-oncological disease. Patients were randomly assigned to receive either prophylactic intravenous unfractionated heparin (continuous infusion of 100 IU/kg/daily) or 50 ml/daily of normal saline solution as a continuous infusion. CVLs were externalized, non tunneled, double lumen catheters. All CVLs were placed percutaneously by the same physician in the subclavian vein. Upper limb veins were systematically examined by ultrasonography just before, or <24 hours after, catheter removal, and in case of clinical signs of thrombosis. One hundred and twenty-eight CVLs were inserted. Catheter-related thrombosis occurred in 1.5% of the catheters inserted in patients of the heparin group, and in 12.6% in the control group (p = 0.03). No other risk factors were found for the development of catheter-related thrombosis. Two and three patients experienced severe bleeding in the heparin group, and in the control group, respectively (p = 0.18). There were no other side-effects clearly ascribable to the use of unfractionated heparin. This is the first prospective, randomized study, which shows that low-dose of unfractionated heparin is safe and effective to prevent catheter-related thrombosis in patients with haemato-oncological disease.

Adolescent↗
PubMed2006

Randomize, then consent: a strategy for improving patient acceptance of participation in randomized controlled trials.

When arthroscopic surgeons are attempting to resolve questions of a therapeutic or clinical nature, randomized controlled trials (Level I evidence) are most helpful. However, patients may be reluctant or unwilling to participate in randomized controlled trials. To improve the feasibility of conducting a randomized controlled trial, a strategy for improving patients' willingness to participate is proposed. The strategy is simple: randomize, then consent. This strategy allows for an informed consent process more specifically focused on the specific treatment to which the patient has been assigned. This may be less confusing, daunting, and frightening to patients, who thus may be more willing to participate in the randomized controlled trial. A disadvantage of randomization before consent is that randomization, temporally, is more distant from the actual treatment or intervention. However, randomization before consent may represent a compromise promoting both better quality consent and increased patient willingness to participate in randomized controlled trials.

Arthroscopy↗
PubMed1997

Assessing social work effectiveness in child care practice: the contribution of randomized controlled trials.

This article discusses the role of randomized controlled trials (RCTs) in evaluating the impact of social work interventions with children. While recognizing the difficulties of applying RCTs to all aspects of practice, we argue that controlled trials can provide the most convincing evidence of the impact of social work activities on the welfare of children and families. Accumulating evidence of the effectiveness of interventions, we propose, should constitute the core business of social work research. To this end, it is necessary to recognize the primacy of the randomized controlled trial in exploring the relationship between social work activities and client outcomes.

Child↗
PubMed2004

Randomized controlled trials of socially complex nursing interventions: creating bias and unreliability?

BACKGROUND: The randomized controlled trial is viewed by many researchers as the 'gold standard' research design. It is used increasingly to evaluate the effectiveness of socially complex activities such as nursing interventions. This use is seen by many commentators as problematic, while others are concerned about the quality of many published trial reports. One area of concern is that of intervention bias: the impact that a sentient intervention, such as a nursing one, may have consciously or unconsciously on study outcomes. This paper reports on an analysis of intervention definitions and possible intervention bias in 47 reports of randomized controlled trials of nursing interventions published in 2000 or 2001. AIMS: This study evaluates four characteristics of the included reports: intervention sample size, intervention definition, involvement of intervention nurses in other aspects of the trial, and the claimed generalizability of results. METHODS: Reports of randomized controlled trials published in 2000 or 2001 were identified. Full-text versions of 47 papers were obtained and information about the four characteristics was extracted and analysed. RESULTS: Problems relating to possible intervention bias were identified in each of the papers. Inadequate intervention definition was the commonest problem, leading to difficulties in calculating the 'intervention dose' and in replicating or generalizing from the studies. DISCUSSION: None of the included studies met the requirements of the Consolidated Standards of Reporting Trials. Four types of intervention bias were identified, and their possible implications for the reporting of trials of nursing interventions are discussed. This was a small-scale study, limited by time and resources. Its results are suggestive of a major problem of intervention bias but larger-scale investigations are necessary to quantify its extent. CONCLUSIONS: Intervention bias is potentially a problem in randomized controlled trials. Lack of detail about interventions in published papers could be corrected by stricter adherence to guidelines such as the Consolidated Standards of Reporting Trials, but this will not correct the underlying problem of inadequate study design that appears to be widespread in randomized controlled trials of nursing interventions.

Bias↗
PubMed2006

Single- versus two- layer intestinal anastomosis: a meta-analysis of randomized controlled trials.

BACKGROUND: To compare single- with two- layer intestinal anastomosis after intestinal resection: a meta-analysis of randomized controlled trials. METHODS: Randomized controlled trials comparing single- with two-layer intestinal anastomosis were identified using a systematic search of Medline, Embase and the Cochrane Library Databases covering articles published from 1966 to 2004. Outcome of primary interest was postoperative leak. A risk ratio for trial outcomes and weighted pooled estimates for data were calculated. A fixed-effect model weighted using Mantel-Haenszel methods and a random-effect model using DerSimonian-Laird methods were employed. RESULTS: Six trials were analyzed, comprising 670 participants (single-layer group, n = 299; two-layer group, n = 371). Data on leaks were available from all included studies. Combined risk ratio using DerSimonian-Laird methods was 0.91 (95% CI = 0.49 to 1.69), and indicated no significant difference. Inter-study heterogeneity was significant (chi2 = 10.5, d.f. = 5, p = 0.06). CONCLUSION: No evidence was found that two-layer intestinal anastomosis leads to fewer post-operative leaks than single layer. Considering duration of the anastomosis procedure and medical expenses, single-layer intestinal anastomosis appears to represent the optimal choice for most surgical situations.

Anastomosis, Surgical↗
PubMed1992

Dexamethasone and bacterial meningitis. A meta-analysis of randomized controlled trials.

A meta-analysis of 5 randomized, controlled trials using dexamethasone as adjunctive therapy in the treatment of bacterial meningitis in children was done to assess the efficacy in reducing sequelae. A 6th study including both children and adults was analyzed separately. Results of the 5 pediatric studies indicated no significant difference in case-fatality rate between the placebo and dexamethasone groups. Significantly more neurologic sequelae were found in the placebo group during the period from discharge from hospital to 6 weeks after discharge (relative risk [RR] = 1.99, 95% confidence interval [CI] 1.13 to 3.53) and during the period beginning 6 months after discharge (RR = 3.90, 95% CI 1.72 to 8.85). The incidence of neurologic sequelae from 6 weeks to 6 months after discharge, though less with dexamethasone administration, did not reach statistical significance. The frequency of bilateral hearing loss was significantly greater in the placebo group (RR = 4.12, 95% CI 1.74 to 9.79), but unilateral loss was not statistically different in the two groups. Dexamethasone administration in addition to antimicrobial therapy appears to be effective in reducing neurologic sequelae and bilateral hearing loss associated with bacterial meningitis in children.

Adult↗
PubMed2005

Day treatment programme for patients with eating disorders: randomized controlled trial.

AIM: This paper reports a randomized controlled trial to compare the effects of day treatment programmes for patients with eating disorders with those of traditional outpatient treatment. BACKGROUND: Eating disorders are common, especially in adolescents, and their worldwide prevalence is increasing. Treatment interventions for patients with eating disorders have traditionally been offered on an outpatient or inpatient basis, but the recent introduction of day hospital programmes offers the possibility of greater cost-effectiveness and relapse-prevention for this population. METHODS: Volunteers from an outpatient clinic for eating disorders were randomly assigned either to a treatment group (n = 21), participating in a modified day treatment programme based on the Toronto Day Hospital Program, or to a control group (n = 22) receiving a traditional outpatient programme of interpersonal psychotherapy, cognitive behaviour therapy and pharmacotherapy. Data were collected from January to December 2002 using the Eating Disorder Examination, Eating Disorder Inventory-2, Beck Depression Inventory, and Rosenberg Self-Esteem Scale. RESULTS: Participants in the day treatment programme showed significantly greater improvements on most psychological symptoms of the Eating Disorder Inventory-2, frequency of binging and purging, body mass index, depression and self-esteem scores than the control group. They also showed significant improvement in perfectionism, but the group difference was not significant. CONCLUSION: Nurses in day treatment programmes can play various and important roles establishing a therapeutic alliance between patient and carer in the initial period of treatment. In addition, the cognitive and behavioural work that is vital to a patient's recovery, that is, dealing with food issues, weight issues and self-esteem, is most effectively provided by a nurse therapist who maintains an empathic involvement with the patient.

Adult↗
PubMed2005

[Direct costs of acute day hospital care: results from a randomized controlled trial].

OBJECTIVE: So far only five randomized controlled trials on acute day hospital care have assessed direct health care costs and compared these with costs of conventional inpatient treatment. This paper aims to close this research gap for German speaking countries. METHOD: Another trial was conducted at the Department of Psychiatry and Psychotherapy, Dresden University of Technology. Using the Client Service Receipt Inventory interviews with patients at three time-points (admission, discharge, three months after discharge) assessed their utilization of health care services. Based on the results of a separate regional cost-calculation project, costs of individual care packages could be calculated. 144 patients (day care: n = 75, inpatient care: n = 69) with complete data sets for all time-points of assessment were included in the intention-to-treat-analysis. Means of direct costs (given in Euro and referred to Deutsche Mark prices in 2000) were computed, and t-tests and bootstrap-procedures were used for group comparison. Furthermore, missing and sensitivity analyses were conducted. RESULTS: Patients in the acute day hospital caused mean direct health care costs of 12 401 per person within the entire period assessed. Thus, their cost level falls below the mean costs of inpatient care (15,924 euro per person) by 22.1 %. Missing analyses showed no selection effects on cost results caused by patients who could not be assessed at all defined time-points. Costs for inpatient and day care services were the most sensitive parameters for maintaining the statistically significant differences of cost means demonstrated between the two study groups. CONCLUSION: For German-speaking countries, this study shows for the first time that acute day care -- which has been demonstrated to be clinically at least as effective as inpatient care - is the less expensive option if these two settings are comparatively assessed.

Acute Disease↗