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Results for “Randomized controlled trials”

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PubMed2003

Antioxidant vitamin supplementation in Crohn's disease decreases oxidative stress. a randomized controlled trial.

OBJECTIVE: We showed previously that patients with Crohn's disease (CD) had increased oxidative stress and lower antioxidant vitamins compared with healthy controls. This is despite inactive or mildly active disease and maintenance therapy. The aim of this study was to evaluate in these patients the effects of antioxidant vitamin supplementation on oxidative stress. METHODS: This is a randomized controlled trial where stable but oxidatively stressed CD subjects (n = 57) were supplemented with vitamins E (800 IU) and C (1000 mg) or their placebo for 4 wk. Oxidative stress measured by breath pentane and ethane output, plasma lipid peroxides, and F2-isoprostane was assessed at baseline and at 4 wk. Disease activity was also monitored by measuring CD activity index and plasma orosomucoid. RESULTS: During supplementation, plasma vitamin C and alpha-tocopherol increased and all indices of oxidative stress decreased significantly. Disease activity remained stable. CONCLUSIONS: In this population, vitamin E and C supplementation resulted in a significant reduction in oxidative stress. This suggests that patients with inactive or mildly active CD can be oxidatively stressed and have increased requirement in antioxidant vitamins.

Adult↗

PubMed2004

Slow versus fast enteral feed advancement in very low birth weight infants: a randomized control trial.

OBJECTIVE: To evaluate the tolerance of rapid advancement of enteral feeds in VLBW babies. SETTING: Tertiary teaching hospital. DESIGN: Randomized controlled trial. METHODS: All stable neonates with birth weight less than 1250 grams were included in the study. The primary outcome variable was the time taken to achieve full enteral feeds (defined as 180 ml/kg/day). The secondary outcome variables were incidence of Necrotizing enterocolitis (NNEC) and incidence of apnea. At 48 hours, the infants were randomized into the slow advancement group (enteral feeds advanced by increments of 15 ml/kg/day) or fast advancement group (enteral feeds advanced by increments of 30 ml/kg/day). The monitoring during feeding included daily weight record, two hourly abdominal girth charting, gastric aspirates, apnea, time taken to reach full enteral feedings and for NNEC. RESULTS: There were 53 infants who were enrolled for the study (27 in the fast advancement group and 26 in the slow advancement group). In the fast advancement group, 20 percent completed the trial; whereas 14 (53.8 percent;) in the slow advancement group completed the study. The two groups were comparable for birth weights, gestational age, sex, intrauterine growth status, Apgar and CRIB scores. The infants in the fast group reached full enteral intake of 180 ml/kg/day significantly earlier (10 +/- 1.8 days) than in the slow group (14.8 +/- 1.5 days). The two groups were comparable for episodes of feed intolerance, apnea, NNEC. Infants in the fast group regained birth weight significantly earlier (median 18 days) than in the slow advancement group (median 23 days). CONCLUSIONS: Stable VLBW neonates can tolerate rapid advancements of enteral feeding without increased risk of adverse effects.

Apnea↗

PubMed2004

Reported use of data monitoring committees in the main published reports of randomized controlled trials: a cross-sectional study.

BACKGROUND: We describe a review of published main reports of randomized controlled trials (RCTs), in order to measure the frequency of reported use of data monitoring committees (DMCs) and factors associated with reported DMC use. METHODS: Twenty-four higher impact general and specialist medical journals were handsearched for main reports of RCTs in order to provide a cross-sectional sample of trials published in the year 2000. Additionally, the same general medical journals were handsearched for 1990 to allow a comparison across time. RESULTS: Of 662 RCTs published in 2000, 120 (18%) explicitly reported using a DMC, while 107 (16%) reported planned interim analyses. Overall, about a quarter (24%) reported at least one of these. A higher proportion of trials reported using a DMC in 2000 than 1 990 (70/282, 25% versus 21/204, 10%) in the general medical journals. Logistic regression models suggested the more important variables associated with increased reported DMC use were: later year of publication, publication in general medical journal, survival-based endpoint, multicentre trial, increasing number of patients recruited, at least one arm involving a placebo, at least one arm involving a drug, factorial design and USA involvement in the trial. CONCLUSIONS: In 2000, about a quarter of main RCT reports mention use of a DMC. Actual use of DMCs is likely to be somewhat greater. Reporting use of a DMC was more likely for larger and longer trials among other factors. We believe the factors affecting reported use affect actual use. It is recommended that when a DMC oversees a trial, brief details should be explicitly included in the main trial paper. Standard nomenclature for DMCs is recommended.

Clinical Trials Data Monitoring Committees↗

PubMed1989

Randomized controlled trial of anti-smoking advice by nurses in general practice.

Practice nurses are playing an increasingly prominent role in preventive care, including the provision of anti-smoking advice during routine health checks. A randomized controlled trial was designed to assess the effectiveness of anti-smoking advice provided by nurses in helping smokers to stop smoking. A total of 14,830 patients aged 16-65 years from 11 general practices completed a brief questionnaire on general health, including smoking status, at surgery attendance. The doctor identified 4330 smokers and randomly allocated 4210 to control or intervention groups. The doctor asked those in the intervention group to make an appointment with the practice nurse for a health check. The attendance rate at the health check was 26%. Smokers were sent follow-up questionnaires at one month and one year, and those who did not respond to two reminders were assumed to have continued to smoke. There was no significant difference in reported cessation between the intervention and control groups at one month or one year. However, there was a significant difference in the proportion of patients who reported giving up within one month and who had not lapsed by one year--0.9% in controls and 3.6% in the intervention group (P less than 0.01). Nevertheless, the effect of the nurse intervention itself may be small as the sustained cessation rate in attenders was only 42.4% higher than in non-attenders. The deception rate in reporting cessation, as measured by urinary cotinine, was of the order of 25%.

Adolescent↗

PubMedDate not supplied

The uncertain consultation and patient satisfaction: the impact of patients' illness perceptions and a randomized controlled trial on the training of physicians' communication skills.

OBJECTIVE: To identify predictors of patient satisfaction among a range of patient and practitioner variables. In particular, to focus on patients' illness perceptions and the impact of a randomized controlled trial on the training of physicians in general communication skills and how to treat patients presenting with poorly defined illness. METHODS: A randomized controlled follow-up study conducted in 28 general practices in Aarhus County, Denmark. Half of the physicians were randomized into an educational program on treatment of patients presenting with medically unexplained symptoms (somatization). One thousand seven hundred eighty-five general practice attenders presenting a new health problem completed questionnaires on illness perceptions, physical functioning, and mental distress before the consultation. After the consultation, a questionnaire including relational and communicative domains of patient satisfaction with the current consultation was completed. The physicians completed a questionnaire for each patient on diagnostics and prognostics. Predictors of patient satisfaction were determined by logistic regression. RESULTS: A large number of patient and practitioner variables predicted satisfaction in univariate logistic regression models. Results from a multivariate logistic model showed that the illness perceptions "uncertainty" (patient not knowing what is wrong) and "emotional representations" (the complaint making the patient feel worried, depressed, helpless, afraid, hopeless) predicted dissatisfaction at OR (CI) = 1.8 (1.3-2.4), p < .001 and OR (CI) = 1.5 (1-2.3), p = .03 respectively. Trained physicians were associated with dissatisfaction at OR (CI) 0.7 (0.5-1), p = .06 in the multivariate model. Furthermore, uncertain patients consulting a trained physician were less likely to be dissatisfied OR (CI) = 0.6 (0.3-1), p = .04. CONCLUSIONS: A randomized controlled trial on the training of general practitioners' communication skills improved patient satisfaction. Illness perceptions predict satisfaction. In particular, patients feeling uncertain and negatively emotionally involved in their health problem were more inclined to being dissatisfied with the consultation.

Adolescent↗

PubMed2003

Rehabilitation after critical illness: a randomized, controlled trial.

OBJECTIVE: To evaluate the effectiveness of a rehabilitation program following critical illness to aid physical and psychological recovery. DESIGN: Randomized controlled trial, blind at follow-up with final assessment at 6 months. SETTING: Two district general hospitals and one teaching hospital. PATIENTS: Patients were 126 consecutively admitted intensive care patients meeting the inclusion criteria. INTERVENTIONS: Control patients received ward visits, three telephone calls at home, and clinic appointments at 8 wks and 6 months. Intervention patients received the same plus a 6-wk self-help rehabilitation manual. MEASUREMENTS AND MAIN RESULTS: We measured levels of depression and anxiety (Hospital Anxiety and Depression Scale), phobic symptoms (Fear Index), posttraumatic stress disorder (PTSD)-related symptoms (Impact of Events Scale), and scores on the Short-Form Health Survey physical dimension 8 wks and 6 months after intensive care unit (ICU) treatment. Memory for ICU was assessed at 2 wks post-ICU discharge using the ICU Memory Tool.The intervention group improved, compared with the control patients, on the Short-Form Health Survey physical function scores at 8 wks and 6 months (p =.006), and there was a trend to a lower rate of depression at 8 wks (12% vs. 25%). However, there were no differences in levels of anxiety and PTSD-related symptoms between the groups. The presence of delusional memories was correlated significantly with both anxiety and Impact of Events Scale scores. CONCLUSIONS: A self-help rehabilitation manual is effective in aiding physical recovery and reducing depression. However, in those patients recalling delusional memories from the ICU, further psychological care may be needed to reduce the incidence of anxiety and PTSD-related symptoms.

Adolescent↗

PubMed2005

Conversion to on pump from OPCAB is associated with increased mortality: results from a randomized controlled trial.

OBJECTIVE: Recent developments in cardiac stabilization devices, have made OPCAB feasible. However, there is conflicting evidence to date regarding the rate and adverse events associated with conversion from OPCAB to CABG with CPB. The objective of the present study was to review all conversions in the setting of a randomized controlled trial comparing CABG with or without CPB. METHODS: Three hundred patients requiring CABG surgery at a single institution were prospectively randomized to have the procedure performed with CPB (n=150) or OPCAB (n=150). Patients that could not be performed OPCAB were defined as conversion group (cross over). RESULTS: Twenty patients were converted from OPCAB to CABG with CPB because of hemodynamic instability (14/20), small target vessel (5/20), or inadequate visualization (1/20). Seventeen were converted during attempts at coronary anastomosis: LAD/diagonal (7/20), circumflex (8/20), or right coronary (2/20). The overall in hospital mortality rate for the trial was 1% but was significantly higher in converted patients (10 vs. 0%; P=0.01). Converted patients required significantly more inotropes (P=0.001) and blood transfusions (P=0.05). An elevated BMI was the only pre-operative variable that appeared to be associated with conversion. CONCLUSIONS: In the setting of a randomized controlled trial the overall conversion rate associated with OPCAB reached 13% and was associated with an increased risk of mortality.

Adult↗

PubMed2004

Impact of a national rural youth health and safety initiative: results from a randomized controlled trial.

OBJECTIVES: We conducted a comprehensive evaluation of a rural youth health and safety initiative implemented in 4000 National FFA (formerly Future Farmers of America) chapters across the United States. METHODS: Data were collected from high school students and their FFA advisers at 3 time intervals (preintervention, immediate postintervention, and 1 year postintervention) with a 3-group (standard, enhanced, and control), cluster-randomized, controlled trial design. RESULTS: Matched data from 3081 students and 81 advisers revealed no significant effect of this initiative on agricultural health and safety knowledge, safety attitudes, leadership, self-concept, and self-reported injuries of project participants. Data from 30 public health nurses following the intervention confirmed the program's failure to develop sustainable community partnerships. CONCLUSIONS: This nationally coordinated initiative was funded with more than $1 million donated by agribusinesses. Program implementation was inconsistent, and desired outcomes were not achieved. Future efforts should better guide effective use of private sector resources aimed at reducing agricultural disease and injury among rural youths.

Accident Prevention↗

PubMed1990

The effects of comprehensive home physiotherapy and supervision on patients with ankylosing spondylitis--a randomized controlled trial.

Fifty-three patients with ankylosing spondylitis (AS) were randomly allocated; 26 experimental patients received physiotherapy and disease education, 27 control patients received neither. The primary treatment outcome was change in spinal mobility measured at 4 months by fingertip-to-floor distance. Experimental patients had more improvement in fingertip-to-floor distance (p2 less than 0.004) and in function (p2 less than 0.001) than control patients. Physiotherapy with disease education is effective in the treatment of patients with AS.

Adolescent↗

PubMed2001

A randomized controlled trial assessing the health economics of realtime teledermatology compared with conventional care: an urban versus rural perspective.

A randomized controlled trial was carried out to measure the cost-effectiveness of realtime teledermatology compared with conventional outpatient dermatology care for patients from urban and rural areas. One urban and one rural health centre were linked to a regional hospital in Northern Ireland by ISDN at 128 kbit/s. Over two years, 274 patients required a hospital outpatient dermatology referral--126 patients (46%) were randomized to a telemedicine consultation and 148 (54%) to a conventional hospital outpatient consultation. Of those seen by telemedicine, 61% were registered with an urban practice, compared with 71% of those seen conventionally. The clinical outcomes of the two types of consultation were similar--almost half the patients were managed after a single consultation with the dermatologist. The observed marginal cost per patient of the initial realtime teledermatology consultation was 52.85 Pounds for those in urban areas and 59.93 Pounds per patient for those from rural areas. The observed marginal cost of the initial conventional consultation was 47.13 Pounds for urban patients and 48.77 Pounds for rural patients. The total observed costs of teledermatology were higher than the costs of conventional care in both urban and rural areas, mainly because of the fixed equipment costs. Sensitivity analysis using a real-world scenario showed that in urban areas the average costs of the telemedicine and conventional consultations were about equal, while in rural areas the average cost of the telemedicine consultation was less than that of the conventional consultation.

Adolescent↗

PubMed2004

A randomized controlled trial of weight-bearing versus non-weight-bearing exercise for improving physical ability after usual care for hip fracture.

OBJECTIVE: To compare the effects of weight-bearing and non-weight-bearing home exercise programs and a control program on physical ability (strength, balance, gait, functional performance) in older people who have had a hip fracture. DESIGN: Randomized controlled trial with 4-month follow-up. SETTING: Australian community-dwellers (82%) and residents of aged care facilities who had completed usual care after a fall-related hip fracture. PARTICIPANTS: One hundred twenty older people entered the trial, 40 per group (average age +/- standard deviation, 79+/-9y) and 90% completed the 4-month retest. INTERVENTION: Home exercise prescribed by a physical therapist. MAIN OUTCOME MEASURES: Strength, balance, gait, and functional performance. RESULTS: At the 4-month retest, there were differences between the groups in the extent of improvement since the initial assessment for balance (F(10,196)=2.82, P<.001) and functional performance (F(6,200)=3.57, P<.001), but not for strength (F(12,190)=1.09, P=.37) or gait (F(8,200)=.39, P=.92). The weight-bearing exercise group showed the greatest improvements in measures of balance and functional performance (between-group differences of 30%-40% of initial values). CONCLUSIONS: A weight-bearing home exercise program can improve balance and functional ability to a greater extent than a non-weight-bearing program or no intervention among older people who have completed usual care after a fall-related hip fracture.

Activities of Daily Living↗

PubMed1994

Randomized, controlled trial of nasopharyngeal continuous positive airway pressure in the extubation of very low birth weight infants.

We conducted a prospective, randomized controlled trial to determine whether extubation of very low birth weight infants was facilitated by the use of nasopharyngeal continuous positive airway pressure (CPAP). Eligible infants included patients weighing 600 to 1500 gm at birth who required tracheal intubation within 48 hours of birth and who met specific predetermined criteria for extubation by day 14 of life. We also sought to determine whether varying the duration of nasopharyngeal CPAP influenced the likelihood of successful extubation. Infants underwent random assignment to receive nasopharyngeal CPAP until resolution of lung disease (n = 40), 6 hours of nasopharyngeal CPAP (n = 42), or oxygen supplementation delivered by hood (n = 42). Extubation failure was predefined as a requirement for > or = 80% oxygen, pH < or = 7.20, severe apnea, or predefined clinical deterioration, and extubation success was predefined as the ability to remain free of a requirement for mechanical ventilation for 7 days and a 66% reduction in the need for supplemental oxygen. Each group was similar with regard to race, sex, and birth weight. Extubation was successful in 62%, 61%, and 60% of infants. After stratification by birth weight, there were no significant differences in the rates of successful extubation among the treatment groups. We conclude that nasopharyngeal CPAP does not improve the likelihood of successful extubation of very low birth weight infants who are ready for extubation within the first 2 weeks of life.

Female↗

PubMed2001

Randomized controlled trial of sheaths in diagnostic neuroangiography.

PURPOSE: To determine the value of arterial sheaths in diagnostic neuroangiography in a randomized controlled trial. MATERIALS AND METHODS: A total of 842 patients (411 men, 431 women; mean age, 59.4 years; age range, 29.5-94.3 years) undergoing diagnostic neuroangiography were randomly assigned to groups in which a sheath was introduced immediately after puncture of the femoral artery (sheath group) or in which a diagnostic catheter was introduced without a sheath (control group). Two hundred twenty-four (26.7%) of 839 patients were receiving anticoagulants immediately prior to the procedure. RESULTS: Complications (mostly small hematomas of the groin) occurred in 106 (12.6%) of 842 patients, with no difference between groups (53 [12.6%] of 421 patients in both; P >.99). Ease of catheter manipulation was greater in the sheath group than in the control group. Incidence of bleeding at the femoral puncture site during the procedure was less in the sheath group (seven [1.7%] of 421 patients) versus the control group (150 [35.6%] of 421 patients), with a P value less than.001. Because of bleeding, sheath insertion was necessary in 165 (39.2%) of 421 patients in the control group. This crossover group also had a higher rate of local complications (28 [17.0%] of 165 patients) than the sheath and control groups. Serious complications, such as stroke (one [0.12%] of 842 patients) and transient ischemic attacks (five [0.60%] of 842 patients), occurred with equal frequency in both the sheath and control groups. CONCLUSION: Use of arterial sheaths lessens the incidence of intraprocedural bleeding at the femoral puncture site and increases ease of catheter manipulation without increasing the number of groin complications.

Adult↗

PubMed1999

[Efficacy and safety of thrombolytic therapy in pulmonary embolism: meta-analysis of randomized controlled trials].

BACKGROUND: The role of thrombolytic agents in the treatment of pulmonary thromboembolism (PTE) remains a controversial issue. The objective of this study is to assess the efficacy and safety of thrombolytic therapy in the treatment of PTE by means of a meta-analysis of randomized controlled trials (RCT). METHODS: A bibliographic search of the main biomedical bibliographic databases was carried out and eight randomized controlled trials that fulfilled the inclusion criteria were found. Two blinded and independent evaluators assessed the quality of RCT according to Jadad scale, and selected the necessary data to fulfill the objective of this study. RESULTS: The selected trials were heterogeneous regarding the type of thrombolytic agent, the administration schedule, and the efficacy measures used. The methodological quality was 2 points in the Jadad scale as an average. No statistically significant differences in mortality nor in risk of PTE relapse were found between the group of patients receiving thrombolytic agents and the group not receiving them. Significant differences were found, however, between these two groups as regards the risk of bleeding events (OR = 2.62; CI 95%: 1.56-4.38). CONCLUSION: The results of these meta-analyses do not suggest the use of thrombolytic therapy in PTE in everyday clinical practice since measurable risks overcome potential benefits.

Fibrinolytic Agents↗

PubMed1999

Bias and precision in visual analogue scales: a randomized controlled trial.

Various types of visual analogue scales (VAS) are used in epidemiologic and clinical research. This paper reports on a randomized controlled trial to investigate the effects of variations in the orientation and type of scale on bias and precision in cross-sectional and longitudinal analyses. This trial was included in the pilot study of the SU.VI.MAX (supplementation by antioxidant vitamins and minerals) prevention trial in France in 1994. Six types of VAS (simple, middle-marked, graphic rating, graduated, graduated-numbered, and numerical rating) and two orientations (horizontal and vertical) were used to measure three symptoms of ear, nose, and throat infection at 2-month intervals in 870 subjects. Differences between scales were analyzed by comparing variances (Levene's test) and means (variance-covariance analysis for repeated measures). Scale characteristics were shown to influence the proportion of zero and low values (i.e., there was a floor effect), but not mean scores. The precision of measurements varied cross-sectionally according to the type of scale, but no differences were observed in the precision of measurement of change over time. In conclusion, the characteristics of VAS seem to be important in cross-sectional studies, particularly when symptoms of low or high intensity are being measured. Researchers should try to reach a consensus on what type of VAS to use if studies are to be compared.

Adult↗

PubMed2003

Cognitive behavioral psychotherapy for depression following stroke: a randomized controlled trial.

BACKGROUND AND PURPOSE: There is inconclusive evidence of the effectiveness of psychological interventions for depression after stroke. We report the results from a randomized controlled trial of cognitive behavioral therapy (CBT). METHODS: Stroke patients admitted to hospital were invited to complete mood questionnaires 1, 3 and 6 months after stroke. Patients who were depressed were invited to take part in a trial and randomly allocated to receive CBT (n=39), an attention placebo intervention (n= 43), or standard care (n=41). Outcome assessments were undertaken at 3 and 6 months after recruitment, on the Beck Depression Inventory, Wakefield Depression Inventory, Extended Activities of Daily Living scale, London Handicap Scale, and a rating of satisfaction with care. RESULTS: There were no significant differences between the groups in patients' mood, independence in instrumental activities of daily living, handicap, or satisfaction with care. CONCLUSIONS: CBT in the treatment of depression following stroke was found to be ineffective in this study. However, because of the small sample size, method of recruitment, and selection criteria, further randomized trials are required.

Aged↗

PubMed2004

A multicenter randomized controlled trial comparing patient-controlled epidural with intravenous analgesia for pain relief in labor.

In this multicenter, randomized, controlled trial, we sought to determine whether patient-controlled epidural analgesia (PCEA) for labor affected the incidence of cesarean delivery when compared with patient-controlled IV opioid analgesia (PCIA). Healthy, term nulliparous patients in 4 Canadian institutions were randomly assigned to receive PCIA with fentanyl (n = 118) or PCEA with 0.08% bupivacaine and fentanyl 1.6 microg/mL (n = 124). There was no difference in the incidence of cesarean delivery-10.2% (12 of 118) versus 9.7% (12 of 124)-or instrumental vaginal delivery-21.2% (25 of 118) versus 29% (36 of 124)-between groups. The duration of the second stage of labor was increased in the PCEA group by a median of 23 min (P = 0.02). Fifty-one patients (43%) in the PCIA group received epidural analgesia: 39 (33%) because of inadequate pain relief and 12 (10%) to facilitate operative delivery. Patients in the PCIA group required more antiemetic therapy (17% versus 6.4%; P = 0.01) and had more sedation (39% versus 5%; P < 0.001). Maternal mean pain and satisfaction with analgesia scores were better in the PCEA group (P < 0.001 and P = 0.02, respectively). More neonates in the PCIA group required active resuscitation (52% versus 31%; P = 0.001) and naloxone (17% versus 3%; P < 0.001). These observations support the hypothesis that PCEA does not result in an increased incidence of obstetrical intervention compared with PCIA. PCEA provides superior analgesia and less maternal and neonatal sedation compared with PCIA.

Adult↗

PubMed2004

Episiotomy and perineal tears presumed to be imminent: randomized controlled trial.

BACKGROUND: The indication of the restricted use of episiotomy at tears presumed to be imminent is not clear. METHODS: Randomized controlled trial with two perineal management policies. Use of episiotomy: (a). only for fetal indications and (b). in addition at a tear presumed to be imminent. PARTICIPANTS: 146 primiparous women with an uncomplicated singleton pregnancy at >34 weeks of gestation. For the intention-to-treat analysis those 109 women were included who vaginally delivered a live full-term baby between January 1999 and September 2000: 49 women in group a, 60 in group b. OUTCOME MEASURES: Reduction of episiotomies, increase of intact perinea or only minor perineal trauma (intact perineum and first-degree tears), third-degree tears, anterior perineal trauma, perineal pain in the postpartum period, pH of the umbilical artery, Apgar scores, maternal blood loss. RESULTS: Episiotomy rates were 41% in group a and 77% in group b (p < 0.001). Women in the restrictive policy group had a greater chance of an intact perineum (29% vs. 10%; p = 0.023) or only minor perineal trauma (39% vs. 13%; p = 0.003) and had significant lower pain scores postpartum at different activities. There were no statistically significant differences with regard to third-degree tears, anterior trauma, pre- and postpartum hemoglobin concentrations, Apgar scores and pH of the umbilical artery. CONCLUSIONS: Avoiding episiotomy at tears presumed to be imminent increases the rate of intact perinea and the rate of only minor perineal trauma, reduces postpartum perineal pain and does not have any adverse effects on maternal or fetal morbidity.

Clinical Protocols↗