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Results for “randomized controlled trials”

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PubMed2003

Application of the Fertilase-laser system versus the conventional mechanical method to immobilize spermatozoa for intracytoplasmic sperm injection. A randomized controlled trial.

A randomized controlled trial was set up to test the hypothesis that the fertilization rate of oocytes after intracytoplasmic sperm injection (ICSI) is higher after immobilization of the spermatozoa with the Fertilase-laser system technology than after immobilization of the spermatozoa with the conventional mechanical method. Metaphase II oocytes were injected with spermatozoa that were immobilized with the conventional mechanical method (group A, n=177) or with spermatozoa that were immobilized with the Fertilase-laser system technology (group B, n=179). The fertilization rate per successfully injected oocyte was comparable in group A (62.6%; 92/147) and in group B (56.3%; 89/158)(p=0.3). No difference could be observed in fertilization rates of oocytes injected with spermatozoa that were immobilized with the Fertilase-laser system technology compared to spermatozoa immobilized with the conventional mechanical method.

Adult↗

PubMed1985

The effectiveness of continuing medical education in changing the behavior of physicians caring for patients with acute myocardial infarction. A controlled randomized trial.

A randomized controlled trial was done to assess the ability of continuing medical education to change physicians' knowledge and behavior in the care of patients with acute myocardial infarction. Patient care practices on eight objectives were audited 6 months before and after physicians completed a 2-hour educational program. Sixty-three physicians from eight randomly selected communities constituted the experimental group and 40 physicians from four similar communities served as controls. The average score for desired care practices over all objectives increased from 48.5% to 60% (p less than 0.001). Three objectives showed significantly greater gains for physicians in the experimental group. The generalizability of these effects was also studied in two additional educational contexts: a multitopic and a unitopic university-based continuing medical education program. Similar significant changes in behavior resulted in both contexts. Significant overall increases in knowledge occurred and persisted for all groups. Continuing medical education can effect changes in physicians' knowledge and care practices that can persist for at least 6 months.

Cardiology↗

PubMedDate not supplied

Accelerated rehabilitation after proximal femoral fracture: a randomized controlled trial.

This randomized controlled trial compared accelerated rehabilitation after surgical treatment of proximal femoral fracture with conventional care and was conducted in a general hospital in an outer urban area. Participating were 261 sequentially admitted patients over the age of 50 years who met predetermined inclusion criteria and all were followed up until death or 4 months after fracture. Patients who were treated with the accelerated rehabilitation programme had a 20% reduction in length of hospital stay. Improved physical independence (as measured by Barthel Index) was observed after fracture in accelerated rehabilitation programme patients with limited pre-existing disability. Non-nursing-home patients receiving accelerated rehabilitation were also less likely to be discharged to nursing-home care or die in hospital. Accelerated rehabilitation led to a substantial reduction in length of hospital stay with a modest short-term improvement in level of physical independence and accommodation status after discharge.

Activities of Daily Living↗

PubMed1999

Patient cost-benefit analysis of teledermatology measured in a randomized control trial.

A randomized controlled trial of the costs and benefits of teledermatology consultations compared with traditional hospital consultations was carried out. Over a nine-month period, 197 patients were referred from general practice for a dermatological opinion, 98 for a teledermatology consultation and 99 for a hospital consultation. Eighty patients required an additional subsequent hospital appointment. Patients were asked to complete an economic questionnaire after each consultation, and 164 questionnaires were returned: 62% of those randomized to the teledermatology consultation responded compared with 58% of those randomized to the hospital consultation. Patients seen by teledermatology at their own health centre had shorter distances to travel and spent less time overall attending the appointment compared with those seen at the hospital. However, the teledermatology consultations were more time-consuming for the general practitioner and dermatologist. These findings indicate that teledermatology has more benefits for the patient than for the health-care delivery team.

Adolescent↗

PubMed1990

Surgical staples in cesarean section: a randomized controlled trial.

This randomized controlled trial compares the use of the Auto Suture Poly CS 57 disposable surgical stapler (n = 98) with standard hysterectomy (n = 102) in low transverse cesarean sections. Subjective assessment of blood loss by the surgeon resulted in lower mean (+/- SEM) total blood loss estimates in the stapled group (492 +/- 24 ml) than in the nonstapled group (579 +/- 38 ml) (p = 0.05). However, surgeon's estimation of blood loss as a result of the hysterotomy and blood loss estimated by the hemoglobin deficit measured on the second postoperative day did not significantly differ between the two groups. The use of the stapling device tended to lengthen the total operating time, which averaged 42.5 minutes in the group with the staples and 39.2 minutes in the group with the standard hysterotomy (p = 0.05). The risk of febrile morbidity, the frequency of endometritis, and the length of hospitalization were similar in the two groups. Our results do not support the routine use of the Auto Suture Poly CS 57 disposable surgical stapler in low transverse cesarean sections.

Adult↗

PubMed1992

Comparative efficacy of spiramycin and erythromycin in acute exudative tonsillitis in adults: a randomized controlled trial.

A randomized control trial was designed to compare the efficacies of spiramycin given one gram twice daily and erythromycin given 500 mg thrice or four times daily in the treatment of acute exudative tonsillitis in adults whose ages were over 13 years old from January 1989 to January 1991 at a community clinic. A total of 120 cases were enrolled in the study. Fifty-three patients received spiramycin while 67 received erythromycin. Group A beta-hemolytic streptococci (GABHS), S. aureus, and positive titer of Mycoplasma pneumoniae were detected in 19, 47 and 8 per cent in spiramycin group and 21, 36 and 11 per cent in erythromycin group respectively. GABHS were totally eradicated on day 3 of treatment in both groups through eradication of S. aureus was slightly slower initially in the spiramycin group. Marked improvement was similarly achieved in both groups after 3 days of therapy. Dyspepsia was felt in 34.4 and 8.2 per cent of erythromycin and spiramycin groups respectively but was tolerable by most patients. We concluded that spiramycin given twice daily was as effectively as conventional erythromycin but spiramycin is more convenient to administer and causes much less gastro-intestinal side-effect.

Acute Disease↗

PubMed1998

Nutrient absorption from a fat-enriched diet in young malnourished children: a randomized controlled trial.

A randomized, controlled trial was undertaken to compare nutrient absorption from low fat (22.2% energy as fat) and high fat (48% energy as fat)-containing mixed diets in 39 (26M, 13F) malnourished children aged < 2 y. Subjects of both dietary groups, standard (SDG, n = 18) and experimental (EDG, n = 21), were offered 184.5 ml of feeds/kg body weight/24 h that provided 146 kcal with the low fat diet and 216 kcal with the high fat diet, respectively. The baseline clinical and biochemical parameters and the volume of feeds consumed by the patients in the two groups were comparable. Thus, the subjects in the EDG were ingesting a mean (95% CI) of 50% (23.8%, 76.2%) extra energy than that eaten by the SDG. Coefficients of absorption of energy, nitrogen and carbohydrate were similar in the two dietary groups (p = 0.08-0.98). Median (binomial exact 95% CI) fat absorption among subjects receiving the high fat diet (96.3; 92.9, 98.6) was 7% more than in those consuming the low fat diet (89.3; 86.7, 94.1) (p = 0.01). Subjects of the EDG thus, retained almost 50% additional energy as compared to that by SDG.

Chi-Square Distribution↗

PubMed1990

Recombinant human interferon alfa-2a in community-acquired non-A, non-B chronic active hepatitis. Preliminary results of a randomized, controlled trial.

A randomized, controlled trial was undertaken to evaluate the response to recombinant interferon alfa-2a in patients with hepatitis B surface antigen negative chronic active hepatitis of unknown aetiology (community-acquired non-A, non-B hepatitis). Thirty patients were treated with thrice weekly interferon in a dose of 6 million units for 1 month, followed by 3 million units for 3 months and 1 million units maintenance therapy for 8 months. Patients who relapsed were returned to the previously effective dose. A control group of 30 patients received no treatment and were followed up for 12 months. Overall, 21/30 (70%) of treated patients had a complete response, with normalization of serum aminotransferase levels, and a further three (10%) had a partial response (a decrease to less than 50% of baseline levels). No significant changes were observed in the control patients. Five (24%) of the 21 complete responders relapsed during months 2-4 and 8/21 (38%) relapsed during maintenance therapy. Three (23%) of these 13 patients had a return to normal serum aminotransferase levels when the dose was increased and 7/13 (54%) demonstrated a significant decrease. In a retrospective analysis of patients' sera for antibody to hepatitis C virus, 23/26 patients testing positive were treatment responders compared to 1/4 antibody negative patients. Our results suggest that interferon alfa-2a is an effective treatment for community-acquired non-A, non-B hepatitis, but reactivation during treatment occurred in 62% of patients. We recommend use of a higher dose of interferon for at least 1 year with long-term follow up in order to exclude early or late reactivation after treatment withdrawal.

Alanine Transaminase↗

PubMed2005

Cluster randomized controlled trials.

Cluster randomized controlled trial (RCT), in which groups or clusters of individuals rather than individuals themselves are randomized, are increasingly common. Indeed, for the evaluation of certain types of intervention (such as those used in health promotion and educational interventions) a cluster randomized trial is virtually the only valid approach. However, cluster trials are generally more difficult to design and execute than individually randomized studies, and some design features of a cluster trial may make it particularly vulnerable to a range of threats that can introduce bias. In this paper we discuss the issues that can lead to bias in cluster randomized trials and conclude with some suggestions for avoiding these problems.

Cluster Analysis↗

PubMed2004

Is fresh frozen plasma clinically effective? A systematic review of randomized controlled trials.

Summary Randomized controlled trials of good quality are a recognized means to robustly assess the efficacy of interventions in clinical practice. A systematic identification and appraisal of all randomized trials involving fresh frozen plasma (FFP) has been undertaken in parallel to the drafting of the updated British Committee for Standards in Haematology guidelines on the use of FFP. A total of 57 trials met the criteria for inclusion in the review. Most clinical uses of FFP, currently recommended by practice guidelines, are not supported by evidence from randomized trials. In particular, there is little evidence for the effectiveness of the prophylactic use of FFP. Many published trials on the use of FFP have enrolled small numbers of patients, and provided inadequate information on the ability of the trial to detect meaningful differences in outcomes between the two patient groups. Other concerns about the design of the trials include the dose of FFP used, and the potential for bias. No studies have taken adequate account of the extent to which adverse effects might negate the clinical benefits of treatment with FFP. There is a need to consider how best to develop new trials to determine the efficacy of FFP in different clinical scenarios to provide the evidence base to support national guidelines for transfusion practice. Trials of modified FFP (e.g. pathogen inactivated) are of questionable value when there is little evidence that the standard product is an effective treatment.

Blood Transfusion↗

PubMed2000

Impact of pharmacy counseling on compliance and effectiveness of combination lipid-lowering therapy in patients undergoing coronary artery revascularization: a randomized, controlled trial.

This randomized, controlled trial evaluated the impact of personalized follow-up on compliance rates in high-risk patients receiving combination lipid-lowering therapy over 2 years. A random sample of 30 patients 7-30 days after cardiac surgery had baseline fasting low-density lipoprotein levels higher than 130 mg/dl. All patients received lovastatin 20 mg/day and colestipol 5 g twice/day. Weekly telephone contact was made with each patient for 12 weeks. Short- and long-term compliance was assessed by pill and packet counts and refill records. Compliance and lipid profile results were significantly better in the intervention group (p<0.05) up to 2 years after the start of therapy than in the control group for all parameters except high-density lipoprotein. However, this effect was not apparent during the first 12 weeks of therapy. Short-term telephone follow-up favorably affected compliance and lipid profile results up to 2 years after start of therapy.

Aged↗

PubMed2005

Extraoral vs intraoral appliance for distal movement of maxillary first molars: a randomized controlled trial.

Using randomized controlled trial methodology, the aim of this study was to evaluate and compare the treatment effects of an extraoral appliance (EOA) and an intraoral appliance (IOA) for distal movement of maxillary first molars. A total of 40 patients (mean 11.5 years, SD 1.29) at the Orthodontic Clinic, National Health Service, Skane County Council, Malmö, Sweden, were randomized to receive treatment with either extraoral traction (cervical headgear) or an IOA using superelastic coils for distal movement of maxillary first molars. The inclusion criteria were a nonextraction treatment plan, a Class II molar relationship and maxillary first molars in occlusion with no erupted maxillary second molars. The outcome measures to be assessed in the trial were treatment time, cephalometric analysis of distal molar movement, anterior movement of maxillary central incisors, ie, anchorage loss and sagittal and vertical skeletal positional changes of the maxilla and mandible. In the IOA group, the molars were distalized during an average time of 5.2 months, whereas in the EOA group the corresponding time was 6.4 months (P < .01). The mean amount of distal molar movement was significantly higher in the IOA than in the EOA group, three mm vs 1.7 mm (P < .001). Moderate anchorage loss was produced with the IOA implying increased overjet (0.9 mm) whereas the EOA created decreased overjet (0.9 mm). It can be concluded that the IOA was more effective than the EOA to create distal movement of the maxillary first molars.

Cephalometry↗

PubMed1997

Benefit of screening mammography in women aged 40-49: a new meta-analysis of randomized controlled trials.

Eight randomized controlled trials (RCTs) of screening mammography have been conducted involving women aged 40-49 at entry. Current data are now available from these trials at 10.5 to 18 years of follow-up (average follow-up time: 12.7 years). Meta-analysis has been performed using a Mantel-Haenszel estimator method to combine current follow-up data from the eight RCTs of mammography that included women aged 40-49 at entry, including new follow-up data presented at the NIH Consensus Development Conference held January 21-23, 1997. Combining the most recent follow-up data on women aged 40-49 at entry into all eight RCTs yields a statistically significant 18% mortality reduction among women invited to screening mammography (relative risk: 0.82; 95% confidence interval: 0.71-0.95). Combining all current follow-up data on women aged 40-49 at entry into the five Swedish RCTs yields a statistically significantly 29% mortality reduction among women invited to screening (relative risk: 0.71; 95% confidence interval: 0.57-0.89). Meta-analysis including the most recent follow-up data from all eight RCTs involving women aged 40-49 at entry demonstrates for the first time a statistically significant mortality reduction due to regular screening mammography in women of this age group.

Adult↗

PubMed2006

Seeking safety therapy for adolescent girls with PTSD and substance use disorder: a randomized controlled trial.

This randomized, controlled trial evaluated a manualized psychotherapy, Seeking Safety (SS), for posttraumatic stress disorder (PTSD) and substance use disorder (SUD) in adolescent females. To our knowledge, no prior study has evaluated any psychotherapy designed for this population. SS was compared to treatment as usual (TAU) for 33 outpatients, at intake, end-of-treatment, and 3 months follow-up. SS evidenced significantly better outcomes than TAU in a variety of domains at posttreatment, including substance use and associated problems, some trauma-related symptoms, cognitions related to SUD and PTSD, and several areas of pathology not targeted in the treatment (e.g., anorexia, somatization). Effect sizes were generally in the moderate to high range. Some gains were sustained at follow-up. SS appears a promising treatment for this population, but needs further study and perhaps additional clinical modification.

Adaptation, Psychological↗

PubMed2026

Comparing the efficacy of chlorhexidine and povidone-iodine for surgical site disinfection: a systematic review and meta-analysis from randomized controlled trials.

BACKGROUND: Randomized controlled trials report conflicting evidence on the efficacy of different skin disinfectants for preventing surgical site infection (SSI). METHODS: We systematically searched PubMed, Web of Science, Cochrane Library, and Embase for RCTs published up to February 2025 comparing preoperative skin disinfection with povidone-iodine (PVI) versus chlorhexidine (CH). Primary outcomes were overall, superficial, deep, and organ/space SSI rates. Secondary outcomes included hospital stay, readmission, and reoperation. RESULTS: CH was superior to PVI in preventing overall SSI (26 studies, n = 29,356; RR: 0.89; 95% confidence interval [CI]: 0.80 to 0.99). The overall SSI incidence rate in the CH group was 7.1% (1,045/14,677), compared with 7.8% (1,152/14,679) in the PVI group, equating to an 11% reduction in relative risk and a 0.7% reduction in absolute risk. The number needed to treat to prevent one SSI was 143. CH demonstrated superiority over PVI in preventing superficial SSI (13 studies, n = 16,867; RR: 0.77; 95% CI: 0.64 to 0.92), but not for deep SSI (11 studies, n = 15,842; RR: 1.00; 95% CI: 0.77 to 1.29) or organ SSI (9 studies, n = 9,471; RR: 1.17; 95% CI: 0.89 to 1.53). No significant differences were found in hospital stay, readmission, or reoperation rates between the two groups. CONCLUSION: CH demonstrates statistical superiority over PVI in preventing overall and superficial SSI, though the absolute clinical benefit is modest. No significant differences were observed for deep or organ/space SSI, nor for secondary outcomes including hospital length of stay, readmission, or reoperation rates.

Humans↗

PubMed2002

Evaluation of a sexual health approach to prevent HIV among low income, urban, primarily African American women: results of a randomized controlled trial.

This randomized controlled trial evaluated an innovative culturally specific sexual health intervention-targeting, but not limited to, low-income African American women-in which HIV and sexually transmitted disease prevention strategies were combined with comprehensive sexuality education. The intervention was delivered and evaluated in community-based settings to 218 participants randomly assigned to treatment or a no-treatment control group. Participants were interviewed at pretest and 3 and 9 months after the intervention to assess changes in both sexuality and HIV risk variables. The intervention was effective in improving sexual anatomy knowledge at both 3- and 9-month follow-up. For a subset of women engaging in unprotected sex at pretest, the intervention group reported an increase in positive attitudes toward the female condom at 9-month follow-up. Reasons for the weak treatment effect are discussed in the context of challenges inherent in conducting community-based research with high-risk populations and sensitive topics. Recommendations are provided for improving sample attrition, statistical power, and response bias and for altering the intervention so as to strengthen its impact.

Adolescent↗

PubMed2001

Effects of physical activity counseling in primary care: the Activity Counseling Trial: a randomized controlled trial.

CONTEXT: Physical activity is important for health, yet few studies have examined the effectiveness of physical activity patient counseling in primary care. OBJECTIVE: To compare the effects of 2 physical activity counseling interventions with current recommended care and with each other in a primary care setting. DESIGN: The Activity Counseling Trial, a randomized controlled trial with recruitment in 1995-1997, with 24 months of follow-up. SETTING: Eleven primary care facilities affiliated with 3 US clinical research centers. PARTICIPANTS: Volunteer sample of 395 female and 479 male inactive primary care patients aged 35 to 75 years without clinical cardiovascular disease. INTERVENTIONS: Participants were randomly assigned to 1 of 3 groups: advice (n = 292), which included physician advice and written educational materials (recommended care); assistance (n = 293), which included all the components received by the advice group plus interactive mail and behavioral counseling at physician visits; or counseling (n = 289), which included the assistance and advice group components plus regular telephone counseling and behavioral classes. MAIN OUTCOME MEASURES: Cardiorespiratory fitness, measured by maximal oxygen uptake (VO(2)max), and self-reported total physical activity, measured by a 7-day Physical Activity Recall, compared among the 3 groups and analyzed separately for men and women at 24 months. RESULTS: At 24 months, 91.4% of the sample had completed physical activity and 77.6% had completed cardiorespiratory fitness measurements. For women at 24 months, VO(2)max was significantly higher in the assistance group than in the advice group (mean difference, 80.7 mL/min; 99.2% confidence interval [CI], 8.1-153.2 mL/min) and in the counseling group than in the advice group (mean difference, 73.9 mL/min; 99.2% CI, 0.9-147.0 mL/min), with no difference between the counseling and assistance groups and no significant differences in reported total physical activity. For men, there were no significant between-group differences in cardiorespiratory fitness or total physical activity. CONCLUSIONS: Two patient counseling interventions differing in type and number of contacts were equally effective in women in improving cardiorespiratory fitness over 2 years compared with recommended care. In men, neither of the 2 counseling interventions was more effective than recommended care.

Adult↗

PubMed1988

Fine catheter peritoneal cytology for the acute abdomen: a randomized, controlled trial.

A randomized, controlled clinical trial, of sequential design, was undertaken to determine whether fine catheter aspiration cytology of the peritoneal cavity, using the percentage of neutrophils in the sample as the main test marker, reduces errors about urgent laparotomy in patients admitted to a surgical unit with acute abdominal pain. One hundred and forty-four patients with acute abdominal pain were studied. Of these, 26 were excluded because the test was unlikely to be useful and 20 did not consent. Conventional clinical assessment was undertaken and then the subjects were randomly allocated to have a peritoneal cytology test or not. After the test result was made available, the surgeon(s) decided whether to operate or continue conservative treatment. The correct decision was later ascertained by a blinded clinical referee. With the entry of the 98th patient the difference between the groups achieved the 5% significance level. The groups were well-matched in regard to demographic and other variables. The decision about urgent laparotomy was incorrect in only 8.2% of the test patients, compared with 28.6% of the others. It is concluded that fine catheter aspiration cytology of the peritoneal cavity is likely to reduce the numbers of unnecessary or delayed laparotomies when used in most patients admitted with acute abdominal pain.

Abdomen, Acute↗