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Results for “Randomized controlled trials”

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PubMed2001

Efficacy of a nurse-led multidimensional preventive programme for older people at risk of functional decline. A randomized controlled trial.

OBJECTIVE: To verify the efficacy of a multidimensional preventive programme on functional decline of older people. DESIGN: Randomized controlled trial. SETTING: Community of Sherbrooke City, Quebec, Canada. SUBJECTS: A representative sample of individuals aged over 75 living at home and identified to be at risk of functional decline by postal questionnaire (n = 503). INTERVENTION: Subjects randomized to the study group (n = 250) were assessed at home by a nurse on 12 dimensions (including medication, depressive mood, risk of falls, hearing). A report of the assessment was sent to the general practitioner with recommendations for interventions. A monthly telephone contact was carried out by the nurse for surveillance and to verify if the recommendations had been applied. METHODS: The primary outcome--functional decline--was defined as either death, admission to an institution or increase of > or = 5 points on the disability score of the Functional Autonomy Measurement System (SMAF) scale during the reference year. Secondary outcomes were functional autonomy (on the SMAF), well-being (General Well-being Schedule), perceived social support (Social Provisions Scale) and use of health care services. RESULTS: Of the 494 subjects who completed the study, 48 (19.6%) of 245 in the study group and 49 (19.7%) of 249 in the control group had functional decline (relative risk 1.00; 95% confidence interval 0.82-1.23). There were no differences between the groups in all secondary outcomes. CONCLUSIONS: This study confirms the inefficacy of multidimensional programmes for preventing functional decline in the older population. More effort should be devoted to improving the efficacy of specific interventions for conditions causing functional decline.

Aged↗

PubMed1997

A randomized controlled trial of strict glycemic control and tertiary level obstetric care versus routine obstetric care in the management of gestational diabetes: a pilot study.

OBJECTIVES: The purpose of this study was to determine whether strict maternal glycemic control for the treatment of gestational diabetes lessened the risk of fetal macrosomia, birth trauma, neonatal hypoglycemia, and operative delivery. The aim of the pilot study was to prepare for a multicenter trial by assessing patient acceptance of the study, by determining realistic accrual rates, and by detecting any major adverse outcomes in the control group that received routine obstetric care. STUDY DESIGN: The study was a prospective randomized controlled trial comparing fetal-neonatal and maternal outcomes in 300 women with gestational diabetes. Women randomized to the treatment arm were managed by strict glycemic control and tertiary level obstetric care, and women in the control arm received routine obstetric care. RESULTS: Three hundred women with gestational diabetes mellitus were studied. There was no difference in maternal age, weight, or length of gestation between groups. The treatment mean birth weight was 3437 +/- 575 gm compared with 3544 +/- 601 gm in the control group, a difference of 107 gm (not significant). Macrosomia rates were similar. There was no birth trauma in either group. The frequency of neonatal hypoglycemia and other metabolic complications was the same. The mode of delivery also showed similar patterns. The treatment group had significantly lower preprandial and postprandial glucose levels by 32 weeks' gestation, which continued to term. CONCLUSION: This pilot study suggests that intensive treatment of gestational diabetes mellitus may have little effect on birth weight, birth trauma, operative delivery, or neonatal metabolic disorders. It has demonstrated the safety of proceeding to a multicenter trial of sufficient sample size to confirm these findings.

Adult↗

PubMed1998

Are results of randomized controlled trials useful to psychotherapists?

Two clinicians provided opposite answers to the title question: Persons argued that information from randomized controlled trials (RCTs) is vital to clinicians, and Silberschatz argued that information from RCTs is irrelevant to clinicians. Persons argued that clinicians cannot provide top quality care to their patients without attending to findings of RCTs and that clinicians have an ethical responsibility to inform patients about, recommend, and provide treatments supported by RCTs before informing patients about, recommending, and providing treatments shown to be inferior in RCTs or not evaluated in RCTs. Silberschatz argued that RCTs do not and cannot answer questions that concern practicing clinicians. He advocates alternative research approaches (effectiveness studies, quasi-experimental methods, case-specific research) for studying psychotherapy.

Humans↗

PubMed1996

A randomized controlled trial of salmon calcitonin to prevent bone loss in corticosteroid-treated temporal arteritis and polymyalgia rheumatica.

Patients treated with high-dose or long-term corticosteroids are at risk of accelerated osteoporosis and spontaneous vertebral and traumatic fractures. To assess the efficacy of salmon calcitonin in preventing corticosteroid- induced osteoporosis, 48 patients with newly diagnosed polymyalgia rheumatica, temporal arteritis, and other vasculitides were enrolled in a 2-year, double-blind, randomized, controlled trial. Patients were randomized to receive subcutaneous injections t.i.w. of either 100 IU of salmon calcitonin (25 patients) or placebo (23 patients). After 2 years, 19 and 21 patients, respectively, were evaluable. All patients also received supplemental calcium carbonate (1500 mg daily in divided doses) and vitamin D3 (400 IU daily). Baseline and serial radiologic assessments included dual-energy X-ray absorptiometry (DXA) of the lumbar spine and hip, and spine radiographs to detect vertebral fractures. There were no significant baseline differences between the two study groups. The mean within-subject percentage change in DXA lumbar spine density in the two groups over the 2-year period of the study was only -0.1% (calcitonin plus calcium) versus -0.2% (placebo plus calcium) a nonsignificant difference despite the high mean cumulative corticosteroid doses of 5371 mg and 4680 mg, respectively (NS). The incidence of vertebral fracture was 12.5% (calcitonin plus calcium: 11%, versus placebo plus calcium: 14%, NS), with four fractures in the first year and one fracture in the second year. Higher cumulative cortico-steroid dose was associated with a greater loss in bone density. In rheumatic disease patients starting high-dose, long-term corticosteroids, salmon calcitonin with calcium and vitamin D3 provided no greater bone preservation than that observed with calcium and vitamin D3 alone.

Absorptiometry, Photon↗

PubMed2006

Intensive community pharmacy intervention had little impact on triptan consumption: a randomized controlled trial.

OBJECTIVE: To evaluate the impact of an intensive pharmaceutical care campaign targeting inappropriate use of triptans. DESIGN: Randomized controlled trial. SETTING: 22 community pharmacies in the County of Funen, Denmark. SUBJECTS: A total of 1123 triptan users at intervention pharmacies and 1340 at control pharmacies. INTERVENTION: Intervention pharmacy staff received information on migraine and other types of headache, detection of inappropriate triptan use and other drug-related problems, and techniques for establishing a dialogue with patients. Intervention consisted of a folder and a structured dialogue with the pharmacy staff. The folder included questions aimed at detecting overuse and inappropriate triptan use. MAIN OUTCOME MEASURES: Change in average triptan consumption in doses per month measured by means of a prescription database with information on all purchases of reimbursed drugs at the level of the individual patient. RESULTS: Overall, intervention had no statistically significant short-term impact on patients' consumption of triptans either among incident users (intervention/control ratio 1.02; 95% confidence interval 0.95 to 1.12), or among prevalent users (1.02; 0.97 to 1.08). No effects were observed after 6 and 9 months, apart from a possible borderline effect after 9 months among prevalent users with intermediate triptan consumption (0.93; 0.87 to 1.00). CONCLUSION: The pharmaceutical care campaign did not reduce the use of triptans.

Adult↗

PubMed1999

Distilling the literature: a randomized, controlled trial testing an intervention to improve selection of medical articles for reading.

PURPOSE: To test whether an academic detailing intervention would improve journal reading among residents. METHOD: In 1995-96, the authors conducted a randomized controlled trial at two family medicine residencies in Missouri. Fifty-nine family practice residents were randomized into two groups identical in baseline characteristics; 29 received individual 15-minute educational presentations, based on academic detailing, that emphasized careful selection of medical journal articles for reading. The authors measured the percentage of important journal articles of which the residents were aware, the percentage of those they had read (either abstract only or the whole article), and the percentage of correctly answered knowledge questions. RESULTS: Despite randomization, the residents in the control group indicated on the pretest that they were more likely than were the residents in the intervention group to be aware of and to have read abstracts from selected articles. However, when comparing pretest with posttest results, the intervention group recalled 18.2% (95% CI, 2.0, 34.0) more articles and correctly answered 16.6% (95% CI 3.0, 29.9) more knowledge questions than did the control group. CONCLUSION: A brief intervention increased residents' recall of important articles and knowledge of those articles' conclusions.

Decision Making↗

PubMed2000

Effect of infection control measures on the frequency of upper respiratory infection in child care: a randomized, controlled trial.

BACKGROUND: Acute upper respiratory infections are common in children who attend child care, and preventing transmission of disease in this setting depends on actions by child care staff. We set out to discover whether transmission of respiratory infections in child care could be reduced by improved infection control procedures. METHODS: We performed a cluster, randomized, controlled trial of an infection control intervention conducted in child care centers in 1 city in Australia. The intervention was training of child care staff about transmission of infection, handwashing, and aseptic nosewiping technique. Implementation of the intervention was recorded by an observer. Illness was measured by parent report in telephone interviews every 2 weeks. RESULTS: There were 311 child-years of surveillance for respiratory symptoms. By multivariable analysis, there was no significant reduction in colds in intervention center children across the full age range. However, a significant reduction in respiratory illness was present in children 24 months of age and younger. When compliance with infection control practices was high, colds in these children were reduced by 17%. CONCLUSIONS: This trial supports the role of direct transmission of colds in young children in child care. The ability of infection control techniques to reduce episodes of colds in children in child care was limited to children 24 months of age and under.

Australian Capital Territory↗

PubMed2005

A randomized controlled trial of an individualized motivational intervention on smoking cessation for parents of sick children: a pilot study.

This is a pilot study of a randomized controlled trial of an individualized motivational intervention (IMI) provided by nurses to help smoking parents of sick children quit smoking. Eighty parents who brought their sick children to the hospital were entered into the study. The intervention group received an IMI from a trained nurse counselor and telephone reminders were given 1 week after the intervention. The quit rate at 1 month was 7.5% (95% CI, 0-21) in the intervention group and 2.5% (95% CI, 0-7) in the control group. Preliminary results indicated that the IMI provided by nurses seemed to be effective in helping resistant parents of sick children stop smoking. They also suggested that it was acceptable and feasible to implement such intervention in a pediatric outpatient clinic/ward in Hong Kong.

Adult↗

PubMed1989

Effect of external cephalic version in late pregnancy on presentation at delivery: a randomized controlled trial.

The effect of repeated external cephalic version, performed at between 33 and 40 weeks gestation, on presentation at delivery was studied in a randomized controlled trial comprising 180 pregnant women with breech presentation. No tocolysis, analgesia or anaesthesia was used. Approximately 25% of all attempts in the study group of 90 women were successful; repeated external version resulted in cephalic presentation at delivery in 48% of patients. Spontaneous version to cephalic presentation occurred in 23 (26%) of the 90 women in the control group in whom version was not attempted, indicating a therapeutic gain from the procedure of 22%, with a 95% confidence interval of 8 to 35%. No severe complications of external cephalic version were noted. We conclude that external cephalic version reduces the frequency of breech presentation at delivery. This mainly benefits the mother because of the decrease in the number of caesarean sections and their inherent maternal morbidity.

Adult↗

PubMed1998

Treatment of children with autism: a randomized controlled trial to evaluate a caregiver-based intervention program in community day-care centers.

This study reports on the results of a randomized controlled trial that evaluated a caregiver-based intervention program for children with autism in community day-care centers. Thirty-five preschool children with a DSM III-R diagnosis of autism or pervasive developmental disorder were randomized to an experimental or control group. Children in the experimental group were enrolled in day care and their parents and child care workers received a 12-week intervention consisting of lectures and on-site consultations to day-care centers. In addition, supportive work was undertaken with families. Control subjects received day care alone. In the experimental group, there were greater gains in language abilities, significant increases in caregivers' knowledge about autism, greater perception of control on the part of mothers, and greater parent satisfaction. We conclude that this research design demonstrated that the intervention was significantly superior to day care alone.

Autistic Disorder↗

PubMed2002

General practitioners' use of magnetic resonance imaging: an open randomized trial comparing telephone and written requests and an open randomized controlled trial of different methods of local guideline dissemination.

AIM: To determine the impact and cost-effectiveness of telephone versus written access to magnetic resonance imaging (MRI), and of different strategies for disseminating locally produced guidelines, upon requests by general practitioners (GPs) for knee and lumbar spine investigation. MATERIAL AND METHODS: Two sequential pragmatic open cluster-randomized trials were conducted within 39 general practices. The outcome measure in each trial was concordance of request with local guidelines. Trial 1: practices requested MRI by telephone or in writing. Trial 2: all practices received guidelines, plus either: a practice-based seminar, practice-specific audit feedback, both seminar and feedback, or neither. RESULTS: A total of 414 requests were assessed in the two trials. Trial 1: telephone access cost pound4.86 more per request but rates of concordant requests were equivalent (65%/64%: telephone/written). Trial 2: compared to the control group, costs per practice were pound1911 higher in seminar group, pound1543 higher in feedback group and pound3578 higher for those receiving both. Concordance was greater following the intervention (74% vs 65%; P < 0.05), but there was no difference between the four study groups. CONCLUSIONS: Method of access did not affect concordance. Written access was more cost-effective. Seminars and feedback were no more effective in modifying practice than guidelines alone, which was thus the most cost-effective option.

Chi-Square Distribution↗

PubMed1997

Randomized controlled trial of cyclosporine for treatment of perianal fistulas in dogs.

OBJECTIVE: To evaluate efficacy of cyclosporine for treatment of perianal fistulas in dogs. DESIGN: Randomized, controlled trial. ANIMALS: 20 German Shepherd Dogs with naturally developing perianal fistulas. PROCEDURE: 10 dogs were treated with cyclosporine; the other 10 dogs were given a placebo. Overall improvement and change in total surface area of involvement and depth of the deepest fistula were determined after 4 weeks. Thereafter, cyclosporine-group dogs were treated for an additional 12 weeks and control-group dogs were treated with cyclosporine for 16 weeks. RESULTS: All cyclosporine-group dogs, but none of the control-group dogs, were subjectively improved after 4 weeks. Mean total surface area and mean fistula depth decreased 78 and 62%, respectively, in the cyclosporine-group dogs but increased 29 and 11%, respectively, in the control-group dogs. After 16 weeks of cyclosporine treatment, fistulas had healed in 17 (85%) dogs. However, fistulas recurred in 7 of 17 dogs, and additional cyclosporine treatment or anal sacculectomy and surgical excision of fistulas was necessary. CLINICAL IMPLICATIONS: Cyclosporine appeared to be effective in dogs with perianal fistulas. Even in dogs in which fistulas were not completely healed, cyclosporine administration appeared to be beneficial, because the surgical procedures that were required were less extensive than those that would have been necessary if cyclosporine had not been given.

Animals↗

PubMed1998

A randomized controlled trial of two methods for collection of sterile urine in neonates.

OBJECTIVE: To test whether urethral catheterization (UC) is better than suprapubic bladder aspiration (SPA) as a method for collection of sterile urine in neonates. METHODS: Thirty-three babies, requiring sterile collection of urine, were randomly assigned to either urethral catheterization (n=16), median gestation 28+/-3.9 weeks, median birth weight 968 g (range 650-4100) or SPA (n=17), median gestation 26+/-5.6 weeks, median birth weight 926 g (range 771-4070). The primary outcome was success in obtaining urine. Secondary outcomes were complications and urine culture results. RESULTS: Some urine was obtained in 11 (64.7%) babies in the SPA group and in 13 (81.2%) babies in the catheter group. Sufficient urine for analysis (>0.5 ml) was obtained in 10 (58.8%) in the SPA group versus 5 (31.2%) babies in the catheter group. There were more contaminated specimens in the catheter group but this was not significant in this small study. CONCLUSIONS: In this small randomized controlled trial urethral catheterization offered no significant advantage over SPA.

Cystostomy↗

PubMedDate not supplied

Listening to music decreases need for sedative medication during colonoscopy: a randomized, controlled trial.

BACKGROUND: Music played during endoscopic procedures may alleviate anxiety and improve patient acceptance of the procedure. A prospective randomized, controlled trial was undertaken to determine whether music decreases the requirement for midazolam during colonoscopy and makes the procedure more comfortable and acceptable. METHODS: Patients undergoing elective colonoscopy between October 2003 and February 2004 were randomized to either not listen to music (Group 1; n=40) or listen to music of their choice (Group 2; n=38) during the procedure. All patients received intravenous midazolam on demand in aliquots of 2 mg each. The dose of midazolam, duration of procedure, recovery time, pain and discomfort scores and willingness to undergo a repeat procedure using the same sedation protocol were compared. RESULTS: Patients in Group 2 received significantly less midazolam than those in Group 1 (p=0.007). The pain score was similar in the two groups, whereas discomfort score was lower in Group 2 (p=0.001). Patients in the two groups were equally likely to be willing for a repeat procedure. CONCLUSION: Listening to music during colonoscopy helps reduce the dose of sedative medications and decreases discomfort experienced during the procedure.

Adult↗

PubMed2001

Economic analysis of randomized, controlled trials.

To facilitate the comparison of different treatment strategies, measures have been developed that bring together clinical, quality-of-life, and economic outcomes into summary measures such as the quality-adjusted life year, cost-effectiveness, and cost-utility ratios. A number of different types of economic evaluations have been developed, including cost-minimization, cost-effectiveness, and cost-utility analyses. Performance of economic analyses in association with randomized, controlled trials (RCT) has gained increasing enthusiasm in recent years. However, economic measures in RCTs are often outcomes of secondary interest and associated with frequent missing data and inadequate sample size. Variability in the cost measures used and the lack of agreement on clinically meaningful cost differences further limit the conclusions derived from such studies. Economic analyses should be limited to large trials with important trade-offs between efficacy and cost. The strengths and limitations of such analyses are discussed, and guidelines are offered for proper economic analyses in randomized, controlled trials.

Costs and Cost Analysis↗

PubMed2001

A randomized controlled trial of a community-based consultation service to prevent falls.

BACKGROUND: Multifaceted programs that combine assessment with interventions have been shown to reduce subsequent falls in some clinical trials. We tested this approach to see whether it would be effective if offered as a consultation service using existing health care resources. METHODS: The subjects of this randomized controlled trial had to be aged 65 years or more and had to have fallen within the previous 3 months. They were randomly assigned to receive either usual care or the intervention, which consisted of in-home assessment in conjunction with the development of an individualized treatment plan, including an exercise program for those deemed likely to benefit. The primary outcomes were the proportion of participants who fell and the rate of falling during the following year. Visits to the emergency department and admissions to hospital were secondary outcomes. RESULTS: One hundred and sixty-three subjects were randomly assigned to either the control or the intervention group, and 152 provided data about their falls. There were no significant differences between the control and intervention groups in the cumulative number of falls (311 v. 241, p = 0.34), having one or more falls (79.2% v. 72.0%, p = 0.30) or in the mean number of falls (4.0 v. 3.2, p = 0.43). Analysis of secondary outcomes (health care use) also showed no significant differences between the intervention group and the control group. In the Cox regression analysis, there was no significant difference between the groups in the proportion of subjects having one or more falls (p = 0.55), but there was a significantly (p < 0.001) longer time between falls in the intervention group. In a post hoc subgroup analysis, subjects with more than 2 falls in the 3 months preceding study entry who had been assigned to the intervention group were less likely to fall (p = 0.046) and had a significantly longer time between falls (p < 0.001), when compared with the group who received usual care. INTERPRETATION: The intervention did not decrease significantly the cumulative number of falls, the likelihood of participants having at least one fall over the next year or the mean number of falls. It did increase significantly the time between falls in a survival analysis when age, sex and history of falling were used as covariates.

Accidental Falls↗

PubMed2004

Effect of training on postural control in figure skaters: a randomized controlled trial of neuromuscular versus basic off-ice training programs.

OBJECTIVES: To compare the effect of a neuromuscular training program and a basic exercise program on postural control in figure skaters. DESIGN: Two groups; parallel design; prospective, randomized controlled trial. SETTING: Postural control laboratory, arenas, September 2001 to December 2002. PARTICIPANTS: Forty-four young, healthy figure skaters (18 years +/- 3 years). INTERVENTIONS: Participants were randomly assigned to receive a neuromuscular training program (n = 22) or a basic exercise training program (n = 22). Both programs were completed 3 times per week for 4 weeks, and each session was supervised. MAIN OUTCOME MEASUREMENTS: Participants completed baseline and postintervention measures of postural control on a force plate. Postural control was quantified as the center of pressure (CoP) path length during tests of single-limb standing balance that mimicked figure skating skills and challenged the postural control system to varying degrees. The primary outcome measure was the CoP path length observed during a landing jump test completed with eyes closed. RESULTS: The post intervention CoP path lengths during the more challenging tests were significantly (P < 0.05) lower (indicating better postural control) for the neuromuscular trained group than for the basic exercise-trained group. For the landing jump test completed with eyes closed, the percent improvement in the neuromuscular trained group was significantly greater (mean = 21.0 +/- 22.0%) than the basic exercise trained group (mean = -4.9 +/- 24.9%; P < 0.05). The magnitude of improvement in the neuromuscular-trained group ranged from approximately 1% to 21%, depending on the specific postural control test used. CONCLUSIONS: The results suggest that off-ice neuromuscular training can significantly improve postural control in figure skaters, whereas basic exercise training does not.

Adolescent↗

PubMed1993

A program to enhance clinical use of MEDLINE. A randomized controlled trial.

OBJECTIVE: To determine if a preceptor and individualized feedback improves the performance of physicians in searching MEDLINE in clinical settings. DESIGN: Randomized controlled trial with 2 to 10 months follow-up. SETTING: A 300-bed teaching hospital. PARTICIPANTS: All 392 physicians and physicians-in-training from 6 major clinical departments were invited to participate if they made patient-care decisions during the study period; 79.4% agreed. INTERVENTIONS: All participants were given 2 hours of basic training, then randomized to a control group (no further intervention) or an intervention group in which each person chose a clinical preceptor experienced in MEDLINE searching and received individualized feedback from a study librarian on each of their 1st 10 searches. MAIN OUTCOME MEASURES: The number and proportion of relevant and irrelevant references retrieved for 1st, 4th, and 8th searches of participants were compared with independent librarian searches on the same topics. RESULTS: Intervention group members did not search more often than controls (5.9 searches per month versus 4.7, respectively; P = 0.26) and there were no significant differences in the quality of searches. Rather, search performance for both groups improved, with the average number of relevant references retrieved per search increasing from 4.5 to 7.4 (P < 0.01). The librarian retrieved more relevant citations than participants for the 1st search (P = 0.001) but not for the 4th (P = 0.60) or 8th (P = 0.76) searches. CONCLUSIONS: A program of assigning preceptors and providing feedback on individual searches did not enhance the quantity or quality of searches. Soon after a basic introduction to searching, however, clinicians in both groups improved their search performance.

Clinical Medicine↗