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Results for “Randomized controlled trials”

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At least 1,135 records · Page 63Linked to original sources

PubMed2002

Next-day care for emergency department users with nonacute conditions. A randomized, controlled trial.

BACKGROUND: Because of overcrowding and cost-control efforts, emergency departments are under pressure to refer patients with nonacute conditions to other settings. However, no validated systematic methods exist for safely performing such referrals. OBJECTIVE: To determine the effects on health status and access to care of systematically referring patients with nonacute conditions to next-day primary care. DESIGN: Randomized, controlled trial. SETTING: An emergency department in a public hospital. PATIENTS: 156 adults who used the emergency department on weekdays from 7:00 a.m. to 3:00 p.m. and met criteria for deferred care. The criteria applied to three symptom complexes that account for 33% of U.S. emergency department visits by adults. INTERVENTION: Next-day care at the study site's primary care center or usual same-day care. MEASUREMENTS: Self-reported health status and use of health services during 1-week follow-up. RESULTS: Patients assigned to next-day care did not demonstrate clinically important disadvantages in health status or physician visits compared with usual care patients. In each group, more than 95% of patients were evaluated at least once by a physician, 4% sought health services after their initial evaluation, and no patients were hospitalized or died. At follow-up, both groups reported improved health status and fewer days in bed or with disability, although the deferred care group reported less improvement on all three measures. The 95% CIs were sufficiently narrow to exclude a clinically significant difference in self-reported health status. However, the possibility of 1 additional day in bed or with disability in the deferred care group could not be excluded. CONCLUSIONS: Clinically detailed standardized screening criteria can safely identify patients at public hospital emergency departments for referral to next-day care. However, larger studies are needed to assess the possibility of adverse effects.

Adult↗

PubMed2004

Effects of high-impact exercise on bone mineral density: a randomized controlled trial in premenopausal women.

INTRODUCTION: The purpose of this randomized controlled study was to assess the effects of high-impact exercise on the bone mineral density (BMD) of premenopausal women at the population level. MATERIALS AND METHODS: The study population consisted of a random population-based sample of 120 women from a cohort of 5,161 women, aged 35 to 40 years. They were randomly assigned to either an exercise or control group. The exercise regimen consisted of supervised, progressive high-impact exercises three times per week and an additional home program for 12 months. BMD was measured on the lumbar spine (L1-L4), proximal femur, and distal forearm, by dual-energy X-ray absorptiometry at baseline and after 12 months. Calcaneal bone was measured using quantitative ultrasound. RESULTS: Thirty-nine women (65%) in the exercise group and 41 women (68%) in the control group completed the study. The exercise group demonstrated significant change compared with the control group in femoral neck BMD (1.1% vs -0.4%; p=0.003), intertrochanteric BMD (0.8% vs -0.2%; p=0.029), and total femoral BMD (0.1% vs -0.3%; p=0.006). No exercise-induced effects were found in the total lumbar BMD or in the lumbar vertebrae L2-L4. Instead, L1 BMD (2.2% vs -0.4%; p=0.002) increased significantly more in the exercise group than in the control group. Calcaneal broadband ultrasound attenuation showed also a significant change in the exercise group compared with the control group (7.3% vs -0.6%; p=0.015). The changes were also significant within the exercise group, but not within the control group. There were no significant differences between or within the groups in the distal forearm. CONCLUSIONS: This study indicates that high-impact exercise is effective in improving bone mineral density in the lumbar spine and upper femur in premenopausal women, and the results of the study may be generalized at the population level. This type of training may be an efficient, safe, and inexpensive way to prevent osteoporosis later in life.

Adult↗

PubMed1994

Promoting screening mammography in inner-city settings: a randomized controlled trial of computerized reminders as a component of a program to facilitate mammography.

In a one-year randomized controlled trial, we assessed the effectiveness of a computerized mammography reminder system as a component of a program to increase the use of screening mammography in three health care organizations serving inner-city women in Detroit, Michigan (two sites of a health department, one HMO site, and two sites of a private hospital). Four thousand four hundred and one women older than 40 who had visited a study site in the preceding year were randomly assigned to one of two treatment groups. Limited intervention (LI) included physician and staff breast cancer control education, facilitated mammography appointment scheduling procedures, and elimination of out-of-pocket patient cost for mammography (at three of five sites). Full intervention (FI) included all components of limited intervention plus an additional series of "cues-to-action." These included a mammography reminder form inserted in the medical record of women who were due to have mammography, intended to increase physician referral for mammography appointments, and patient reminders intended to increase completion of mammography among referred women. During the one-year intervention period 2,725 randomized women visited a study site. The 6-month mammography appointment rates among FI women vary from 38% to 65% and the FI rate exceeds the LI rate at each site with differences from 13% (95% CI, 6 to 20) to 29% (21 to 38). The annual completed mammography rate among FI women extends from 43% to 64% and exceeds the LI rate at each site by 12% (5 to 19) to 25% (16 to 34). After age-adjustment, the mammography intervention effect sizes among the five sites were not significantly different. The average increase in FI compared to LI was 18%. The computerized reminder system is effective in increasing the use of mammography in each of the study institutions and the major effect is on physician referral for mammography.

Adult↗

PubMed1990

Self-help materials for anxiety: a randomized controlled trial in general practice.

The efficacy of a self-help package in treating chronic anxiety was evaluated in a randomized controlled trial in which the intervention group received self-help materials in the form of an audiotape and booklet, in addition to their current treatment. The intervention was successful in terms of mean depression scores (P = 0.01), anxiety scores (P = 0.04) and general health questionnaire scores (P = 0.02) which were significantly lower for the intervention group than for the controls. In addition, the depression scores fell faster for the intervention group than for the controls. The overall mean reduction in three months in adjusted depression scores was approximately two points greater for the intervention group than for the controls (P = 0.02). Clinicians welcomed the package as a valuable addition to the therapies available for managing chronic anxiety problems. Further studies should include larger sample sizes, taking into account the non-response to postal questionnaires over time.

Adolescent↗

PubMed1998

Postoperative adjuvant chemotherapy after curative resection of hepatocellular carcinoma: a randomized controlled trial.

OBJECTIVE: To study the effect of adjuvant chemotherapy after curative hepatic resection in patients with hepatocellular carcinoma. DESIGN: A randomized controlled trial. SETTING: A tertiary referral center. PATIENTS: During a 54-month period, 142 patients with hepatocellular carcinoma underwent hepatic resection at 1 institution. Sixty-six patients who survived the operation and had no demonstrable evidence of residual disease on ultrasonographic examination and hepatic angiographic testing at 1 month after surgery agreed to participate in the study. The median follow-up time was 28.3 months. INTERVENTION: Thirty patients received a combination of intravenous epirubicin hydrochloride (8 doses of 40 mg/m2 each at 6-week intervals) and transarterial chemotherapy using an emulsion of iodized oil and cisplatin (3 courses with a maximum dose of 20 mL each at 2-month intervals). Thirty-six patients had no adjuvant treatment. MAIN OUTCOME MEASURES: Recurrence rate and disease-free survival. RESULTS: A total of 138 courses of intravenous epirubicin was given to the 30 patients. Sixty-one courses of transarterial chemotherapy were given to only 29 of the 30 patients assigned to the treatment group, because the hepatic artery in 1 patient was thrombosed. Six patients (20%) had chemotherapy-related complications with no mortality. Twenty-three of 30 patients in the treatment group and 17 of 36 patients in the control group had recurrences (P=.01). Patients who received adjuvant chemotherapy had a higher incidence of extrahepatic metastases (11 patients vs 5 patients; P=.03). The respective disease-free survival rates at 1, 2, and 3 years were 50%,36%, and 18% for the treatment group and 69%, 53%, and 48% for the control group (P=.04). CONCLUSION: In a group of patients who underwent curative resection of hepatocellular carcinoma, postoperative adjuvant chemotherapy using the present regimen was associated with more frequent extrahepatic recurrences and a worse outcome.

Antineoplastic Agents↗

PubMed2000

Paracetamol as a prophylactic analgesic for hysterosalpingography: a double blind randomized controlled trial.

AIM: To evaluate the effectiveness of paracetamol as a prophylactic analgesic for hysterosalpingography (HSG). DESIGN: A prospective double blind randomized controlled trial comparing one 1 g of paracetamol (SmithKline Beecham, Brentford, U.K.) to placebo taken 30 min before HSG. One hundred consecutive out-patients were studied prospectively. The analgesic effectiveness during the procedure and at 24 h and 1 week post procedure was analysed by a postal pain score questionnaire. Additional data on the ethnicity of the patient, sex and level of experience of the radiologist performing the hysterosalpingogram, the parity of the patient, the ease of the procedure, and whether pathology was identified were also recorded. RESULTS: Eighty-eight patients (88%) replied, 39 (44%) received paracetamol and 49 placebo (56%). During the procedure 3/39 (7%) of women in the paracetamol group were pain-free compared to 9/49 (18%) in the placebo group, which was not significant (P = 0.11). At 24 h, 15/39 (38%) of women in the paracetamol group were pain-free compared to 20/49 (41%) in the placebo group, which was not significant (P = 0.82). At 1 week, 27/39 (69%) of women in the paracetamol group were pain-free compared to 29/49 (59%) in the placebo group, which was not significant (P = 0.33). No significant difference in mean pain scores was determined during the procedure (P = 0.91), or at 24 h post procedure (P = 0.94). Similarly, no difference in mean pain scores was identified with regard to the ethnicity of the patient, the sex of the radiologist performing the procedure, the level of experience of the radiologist performing the procedure, or whether pathology was present or not. Difficult cannulations were associated with higher mean pain scores, however, there was no difference in mean pain scores between the paracetamol or placebo groups for both easy and difficult cannulations. CONCLUSION: Paracetamol is not effective as a prophylactic analgesic for HSG. If a prophylactic analgesic is considered necessary for pain relief during HSG we recommend that a non-steroidal anti-inflammatory drug (NSAID) is used.

Acetaminophen↗

PubMed1992

Guideline-based consultation to prevent anticoagulant-related bleeding. A randomized, controlled trial in a teaching hospital.

OBJECTIVE: To test the efficacy of consultation designed to prevent anticoagulant-related bleeding. DESIGN: Randomized, controlled trial. SETTING: A large teaching hospital. PATIENTS: A total of 101 patients at increased (greater than 15%) risk for major, in-hospital bleeding while starting long-term anticoagulant therapy who were identified using a validated prediction rule. INTERVENTIONS: Fifty-five patients received usual care under the direction of the attending physician who had initiated anticoagulant therapy. Forty-six patients received guideline-based consultation in addition to usual care. Guideline-based consultation included individualized review of the risks and benefits of anticoagulant therapy and, on the basis of current practice guidelines, recommendations for daily management. MEASUREMENTS: The main outcome was in-hospital bleeding, which was classified using a reliable, explicit index. RESULTS: Major or minor bleeding occurred in 17 of 55 patients (31%) receiving usual care alone, compared with 6 of 46 patients (13%) receiving consultation in addition to usual care (P = 0.03). The protective efficacy of consultation was 58% (95% CI, 3% to 82%). Consultation was associated with similar reductions in the frequencies of major bleeding (from 13% to 4%) and minor bleeding (from 18% to 9%). Consultative recommendations had an 84% compliance rate and directly affected anticoagulant management: In the consult group, nonsteroidal anti-inflammatory agents were stopped in six patients (13%), and therapeutic ranges were achieved more often for activated partial thromboplastin times (52% compared with 45% in the usual care group, P = 0.08) and for prothrombin times (47% compared with 27% in the usual care group, P less than 0.001). Nearly all housestaff and attending physicians (91%) for patients receiving consultation also reported that consultation improved housestaff learning. The consult group had a somewhat lower rate of thromboembolism in the 90 days after discharge (5% compared with 17%, P = 0.06). Death rates and mean lengths of stay were similar in the two groups. CONCLUSION: Guideline-based consultation was associated with reduction in the frequency of anticoagulant-related bleeding in patients at increased risk for major in-hospital bleeding.

Aged↗

PubMed1995

Streptokinase and Heparin versus Heparin Alone in Massive Pulmonary Embolism: A Randomized Controlled Trial.

To test the efficacy of thrombolytic therapy in massive pulmonary embolism, we conducted a prospective randomized controlled trial. Eight patients were randomized to receive either 1,500,000 IU of streptokinase in 1 hour through a peripheral vein followed by heparin or heparin alone. All patients had major risk factors for deep vein thrombosis (DVT) and were considered to have high clinical suspicion for pulmonary embolism (PE). At baseline all patients had a similar degree of systemic arterial hypotension, pulmonary arterial hypertension, and right ventricular dysfunction. The time of onset of cardiogenic shock in both groups was comparable (2.25 +/- 0.5 hours in the streptokinase group and 1.75 +/- 0.96 hours in the heparin group). The four patients who were randomized to streptokinase improved in the first hour after treatment, survived, and in 2 years of follow-up are without pulmonary arterial hypertension. All four patients treated with heparin alone died from 1 to 3 hours after arrival at the emergency room (p = 0.02). Post-thrombolytic therapy the diagnosis of PE was sustained in the streptokinase group by high probability V/Q lung scans and proven DVT. A necropsy study performed in three patients in the heparin group showed massive pulmonary embolism and right ventricular myocardial infarction, without significant coronary arterial obstruction. The results indicate that thrombolytic therapy reduces the mortality rate of massive acute pulmonary embolism.

Journal Article↗

PubMedDate not supplied

A randomized controlled trial of a decision aid for women at increased risk of ovarian cancer.

PURPOSE: To carry out a randomized controlled trial of a decision aid for women at increased risk of developing ovarian cancer to facilitate decision making regarding risk management options. METHODS: This randomized trial, conducted through 6 familial cancer centers, compared the efficacy of tailored decision aid to that of a general educational pamphlet in preparing women for decision making. PARTICIPANTS: 131 women with a family history of breast and/or ovarian cancer or of hereditary nonpolyposis colorectal cancer. OUTCOME MEASURES: Decisional conflict, knowledge about ovarian cancer risk management options, and psychological adjustment were reassessed at 3 time points. RESULTS: Compared to those who received the pamphlet (control), women who received the decision aid (intervention) were significantly more likely to report a high degree of acceptability of the educational material at both follow-up assessment time points. Findings indicate neither group experienced significant increases in psychological distress at either follow-up assessment time points relative to baseline. Two weeks postintervention, the intervention group demonstrated a significant decrease in decisional conflict compared to the control group (t = 2.4, P < 0.025) and a trend for a greater increase in knowledge about risk management options (t = 2.1, P = 0.037). No significant differences were found 6 months postintervention. CONCLUSION: This form of educational material is successful in increasing knowledge about risk management options and in reducing decisional conflict in the shorter term. The decision aid is an effective and acceptable strategy for patient education to facilitate an inclusive and informed decision-making process about managing ovarian cancer risk.

Anxiety↗

PubMed2006

A 2-arm, randomized, controlled trial of a motivational interviewing-based intervention to improve adherence to antiretroviral therapy (ART) among patients failing or initiating ART.

RATIONALE AND PURPOSE: Motivational interviewing (MI) is a counseling technique that has been used effectively to change a number of health-related behaviors. We sought to assess the impact on patients' antiretroviral therapy (ART) adherence of a multicomponent, MI-based ART adherence intervention compared with that of an HIV informational control program. STUDY DESIGN: Two-arm, randomized, controlled trial. SAMPLE: One hundred forty adult HIV-infected patients attending a large, academic center infectious diseases clinic who were either failing or newly initiating an ART regimen. STUDY ENDPOINTS: (1) Mean adherence level (% of prescribed doses take in the prior month) at the week 12 visit, (2) change in mean adherence, (3) percentage of patients achieving >95% adherence in the third 4-week block, and (4) change in viral load. MAIN FINDINGS: The MI group's mean adherence improved by 4.5% compared with a decrease in the control group's adherence by 3.83% (P = 0.10). In the treatment group, 29% achieved >95% adherence compared with only 17% in the control group (P = 0.13). When we controlled for ethnicity, the intervention group had 2.75 times higher odds of achieving more than 95% adherence than did the controls (P = 0.045; 95% confidence interval: 1.023, 7.398). Although a number of mediating variables (beliefs about ART, coping style, social support, and goals set) had statistically significant changes in the expected direction in the MI group compared with controls, in the intent-to-treat analysis, the mean adherence at study exit for the intervention group was 76% (SD = 27%) and 71% (SD = 27%) for the control group (P = 0.62). CONCLUSION: Although not definitive, this study provides some evidence that MI offers an effective approach to improving adherence. Future studies able to build MI into the intervention for longer than 3 months may have a greater impact.

Academic Medical Centers↗

PubMed2004

Impact of highly purified urinary FSH and recombinant FSH on haemostasis: an open-label, randomized, controlled trial.

BACKGROUND: It has recently been suggested that recombinant FSH administration may result in an increased risk of venous thrombosis. An open-label, randomized, controlled trial was carried out to compare the impact of urinary and recombinant FSH on haemostasis. METHODS: Fifty infertile women were randomized, using a random number generator on a personal computer, to receive either highly purified urinary FSH (u-hFSH) or recombinant human FSH (r-hFSH); a starting dose of 150 IU. Human chorionic gonadotrophin 10000 IU was administered once there was at least one follicle > or =18 mm. The luteal phase was supported with progesterone 50 mg/day for at least 15 days. Fifty normally menstruating women were recruited as controls. Repeated measurements of estradiol, progesterone, prothrombin time (PT) expressed as INR, activated partial thromboplastin time (APTT) ratio, fibrinogen (FBG), factor VIII (FVIII), normalized activated protein C ratio (nAPC ratio), antithrombin III activity (AT), protein C activity (PC), protein S activity (PS), tissue-type plasminogen activator antigen (t-PA), type 1 plasminogen activator inhibitor (PAI), prothrombin fragments 1+2 (F1+2), were performed during both hyperstimulated and natural cycles, and at onset of the following menstruation or at 8 weeks of pregnancy. RESULTS: At the end of gonadotrophin administration PT INR increased in the u-hFSH group, while AT and t-PA significantly decreased. In the patients treated with r-hFSH, only F1+2 significantly decreased. No significant changes were observed in the control group. In the luteal phase FBG increased significantly in all groups. In the u-hFSH group no other significant changes were noted compared to pre-ovulatory values, while compared to baseline values AT, PS and t-PA significantly decreased. In the r-hFSH group during the luteal phase PT INR significantly decreased, but did not differ from baseline levels. Other parameters such as FBG, FVIII, t-PA, rose significantly, but only FVIII and FBG values were significantly higher than baseline levels. In the women who became pregnant a significant increase in t-PA and a significant decrease in PS at the midluteal phase were observed. After one month all the haemostatic parameters returned to baseline value if pregnancy failed to occur, while in the pregnant women a significant increase in FVIII and a significant decrease in PS were observed. CONCLUSIONS: Ovarian stimulation with recombinant FSH does not influence coagulation and fibrinolysis significantly, as already reported for urinary gonadotrophins. The moderate changes induced by both treatments are no longer detectable after 4 weeks.

Adult↗

PubMed2002

A randomized controlled trial of two strategies to implement active sick leave for patients with low back pain.

STUDY DESIGN: Cluster randomized controlled trial. OBJECTIVE: To evaluate the effectiveness of two strategies to improve the use of active sick leave (ASL) for patients with low back pain. SUMMARY OF BACKGROUND DATA: ASL is a public sickness benefit scheme offered to promote early return to modified work for temporarily disabled workers. It was poorly used, and the authors designed two community interventions to strengthen the implementation of ASL based on the results of a study of barriers to use among back pain patients, employers, general practitioners (GPs), and local National Insurance Administration staff. METHODS: Sixty-five municipalities in three counties in Norway, randomly assigned to a passive intervention, a proactive intervention, or a control group. The interventions were targeted at patients on sick leave for low back pain for more than 16 days (n = 6176), their GPs, employers, and local insurance officers. The passive intervention included reminders about ASL on the sick leave form that GPs must complete, a standard agreement to facilitate ASL, targeted information, and a desktop summary for GPs of clinical practice guidelines for low back pain, emphasizing the importance of advice to stay active. The proactive intervention included these elements plus a resource person to facilitate the use of ASL and a continuing education workshop for GPs. The main outcome measure reported here is the proportion of eligible patients that used ASL. RESULTS: ASL was used significantly more in the proactive intervention municipalities (17.7%) compared with the passive intervention and control municipalities (11.5%, P = 0.018). CONCLUSIONS: A passive intervention that addressed identified barriers to the use of ASL did not increase its use. Although modest, a proactive intervention did increase its use. The main impact of the intervention was through direct contact and motivating telephone calls to patients. To the extent that GPs' practice was changed, it was either patient mediated or by patients bypassing their GP.

Cluster Analysis↗

PubMed2003

A randomized controlled trial evaluating the efficacy of tetracaine gel for pain relief from peripherally inserted central catheters in infants.

BACKGROUND: Insertion of peripherally inserted central catheters (PICC) is a commonly performed procedure in both preterm and term infants. Tetracaine 4% gel (Ametop; Smith & Nephew Inc, St. Laurent, Quebec), a topical anesthetic, although reported to be effective for reducing the pain of venipuncture in neonates, has not been investigated for the management of pain associated with the PICC procedure. PURPOSE: To determine the efficacy of tetracaine gel for managing the pain associated with the PICC procedure in preterm and term infants. METHODS: A double-blind, placebo-controlled, randomized controlled trial (RCT) design was used. Infants undergoing nonurgent PICC insertion were randomized to receive either the treatment (1.0 g of tetracaine 4% gel) or placebo control (1.0 g of eucerin-plus cream) applied to the skin under occlusion for 30 minutes before the procedure. Data on the behavioral (facial expression) and physiologic (heart rate and oxygen saturation) indicators of pain were collected via videotaping and computer monitoring throughout the procedure. Data then were coded and measured by independent observers using the Premature Infant Pain Profile (PIPP; Stevens et al, 1996), and analyzed using descriptive statistics and repeated-measures analyses of variance. RESULTS: Forty-nine infants, gestational age 27 to 41 weeks (mean = 33; SD = 4.2) and age at time of insertion 2 to 85 days (mean = 18; SD = 22.5) participated. No differences were found between the groups at the time of randomization. There were no adverse cardiorespiratory events or local skin reactions in either group. There was a significant within-subjects main effect of time across the procedure (F[48,3] = 11.03; P < 0.0001). There was no significant between-subjects main effect of group (F[48,1] = 0.11; P = 0.74) and no (group x time) interaction (F[48,3] = 0.45; P = 0.72). CONCLUSION: Tetracaine gel was not effective for pain relief for PICC insertion in infants. Its use for pain relief cannot be recommended based on the results of this study. Other pharmacologic, behavioral, and physical interventions should be investigated for safety and relief of procedural pain in this population of infants.

Anesthetics, Local↗

PubMed2005

Gait outcomes after additional backward walking training in patients with stroke: a randomized controlled trial.

OBJECTIVE: To examine the effectiveness of additional backward walking training on gait outcome of patients post stroke. DESIGN: Randomized controlled trial. SETTING: Medical centre. SUBJECTS: Twenty-five subjects with stroke, who were lower extremity Brunnstrom motor recovery stage at 3 or 4 and were able to walk 11 m with or without a walking aid or orthosis, randomly allocated to two groups, control (n = 12) and experimental (n = 13). INTERVENTIONS: Subjects in both groups participated in 40 min of conventional training programme three times a week for three weeks. Subjects in experimental group received additional 30 min of backward walking training for three weeks at a frequency of three times per week. MAIN MEASURES: Gait was measured using the Stride Analyzer. Gait parameters of interest were walking speed, cadence, stride length, gait cycle and symmetry index. Measures were made at baseline before commencement of training (pre-training) and at the end of the three-week training period (post-training). RESULTS: After a three-week training period, subjects in experimental group showed more improvement than those in control group for walking speed (change score: 8.60 +/- 6.95 versus 3.65 +/- 2.92, p-value = 0.032), stride length (change score: 0.090 +/- 0.076 versus -0.0064 +/- 0.078, p-value = 0.006), and symmetry index (change score: 44.07 +/- 53.29 versus 5.30 +/- 13.91, p-value = 0.018). CONCLUSIONS: This study demonstrated that asymmetric gait pattern in patients post stroke could be improved from receiving additional backward walking therapy.

Female↗

PubMed2004

Facilitated lipid management using interactive e-mail: preliminary results of a randomized controlled trial.

We describe the design and implementation of a clinical decision support system for ambulatory hyperlipidemia management. Despite readily available and evidence-based guidelines, cholesterol control remains persistently sub-optimal in clinical practice. "FastTrack" is an integrated, multi-faceted informatics tool to reduce barriers to effective cholesterol management by proactively integrating pertinent clinical information, evidence-based decision support and a simple means to act via a single FastTrack e-mail. We tested the intervention in a randomized, controlled trial involving 14 physicians and 276 patients. In an interim analysis, we found that physicians on average were able to review and act upon 9 patient e-mails in less than 15 minutes. Significantly more intervention patients were initiated on a statin therapy or had their dose increased (15.3% vs. 2.3%, p < 0.001). Impact of the intervention on LDL levels will be assessed at trial completion.

Aged↗

PubMed2001

Ultrasound-guided embryo transfer: a prospective randomized controlled trial.

BACKGROUND: Recent reports suggested that ultrasound guidance during embryo transfer might improve the pregnancy rate. METHODS: A prospective randomized controlled trial was performed to compare embryo transfer under ultrasound guidance versus the clinical touch method. A total of 800 embryo transfers was studied; 400 were randomized to ultrasound-guided transfers and 400 were randomized to the clinical touch group. Of these, 441 were fresh cycles and 359 were frozen-thawed cycles. RESULTS: The clinical pregnancy rate was 26.0% in the ultrasound-guided group and 22.5% in the clinical touch group; the difference was not statistically significant. The ongoing pregnancy rate was 23.5% in the ultrasound-guided group compared with 19.0% in the clinical touch group and the difference was again not statistically significant. The implantation rate was slightly higher in the ultrasound-guided group (15.3%) than the clinical touch group (12.0%) (P = 0.048). There were no differences in the incidences of ectopic pregnancy, miscarriage and multiple pregnancy between the two groups. CONCLUSIONS: A significant improvement in implantation rate was observed following the use of ultrasound guidance during embryo transfer. The extent of improvement in the pregnancy rate may depend on the specific techniques and methods of embryo transfer used in individual centres.

Abortion, Spontaneous↗

PubMed1991

Failure of exercise to reduce blood pressure in patients with mild hypertension. Results of a randomized controlled trial.

OBJECTIVE: --To assess the effects of physical exercise training on blood pressure in patients with mild hypertension. DESIGN: --Randomized controlled trial. SETTING: --Hospital-based cardiac rehabilitation program. PATIENTS: --Ninety-nine men and women with untreated mild hypertension (systolic blood pressure, 140 to 180 mm Hg; diastolic blood pressure, 90 to 105 mm Hg) were included in the volunteer sample. INTERVENTIONS: --Subjects were randomly assigned to a 4-month program of aerobic exercise training, strength and flexibility training, or to a waiting list control group. MAIN OUTCOME MEASURES: --The main outcome measures were systolic and diastolic blood pressures measured four times with a random zero sphygmomanometer on 3 separate days in a clinic setting. RESULTS: --After 4 months of exercise training, subjects in the aerobic exercise group did not exhibit greater reductions in blood pressure than subjects in the control group. We expected a differential decline of 5 mm Hg between the aerobic exercise and waiting list control groups and found a difference of -1.0 +/- 16 mm Hg and -1.2 +/- 10 mm Hg at alpha = .05 for systolic and diastolic blood pressure, respectively. CONCLUSIONS: --Moderate aerobic exercise alone should not be considered a replacement for pharmacologic therapy in nonobese patients with mild hypertension.

Adult↗

PubMedDate not supplied

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

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

Attitude to Health↗