SEARCH · PubMed Health

Results for “randomised controlled trial”

Explore indexed PubMed citations for clinical trials, systematic reviews and public health research. Read source abstracts and follow each citation to its original PubMed record.

Quote a phrase for an exact phrase match. Source license links do not imply unrestricted reuse.

At least 91 records · Page 5Linked to original sources

PubMed2000

Treatment of warfarin-associated coagulopathy with oral vitamin K: a randomised controlled trial.

BACKGROUND: Warfarin-associated coagulopathy is a frequent clinical complication. We aimed to assess whether treatment with vitamin K is safe and more effective than placebo in rapidly lowering the international normalised ratio (INR) into the therapeutic range in over anticoagulated patients receiving warfarin. METHODS: We did a multicentre, double-blind, placebo-controlled, randomised trial in five tertiary care hospitals. In this study, patients receiving warfarin who had an INR value between 4.5 and 10.0, and who did not have an indication for the immediate normalisation of their INR, had their warfarin withheld, and were randomly allocated to receive either 1 mg of vitamin K or placebo orally. The primary outcome measure was the INR value on the day after treatment. Secondary outcome measures included INR values on subsequent days, and the risk of haemorrhage and recurrent thrombosis over a 3 month follow-up period. FINDINGS: Patients given vitamin K had a more rapid decrease in the INR than those given placebo (25 of 45 (56%] vs nine of 44 [20%] patients with INR values of 1.8-3.2 on the day after treatment, respectively, p=0.001; odds ratio [OR] 0.21, 95% CI 0.07-0.57). Fewer patients given vitamin K had bleeding episodes during the follow-up period than those given placebo (two [4%] vs eight [17%] patients, respectively, p=0.050; OR 0.87, 95% CI 0.019-0.999). INTERPRETATION: Low dose oral vitamin K is more effective than placebo for the rapid lowering of raised INR values in patients taking warfarin.

Administration, Oral↗

PubMed2006

Glucose tolerance and lipid profile in longterm exogenous subclinical hyperthyroidism and the effects of restoration of euthyroidism, a randomised controlled trial.

OBJECTIVE: The impact of prolonged subclinical hyperthyroidism on glucose and lipid metabolism is unclear. Therefore, we evaluated glucose and lipid metabolism in patients with differentiated thyroid carcinoma (DTC) on TSH suppressive thyroxine therapy as a model for subclinical hyperthyroidism and investigated whether restoration to euthyroidism affects metabolism. DESIGN: We performed a prospective, single-blinded, placebo-controlled, randomised trial of 6 months duration with 2 parallel groups. PATIENTS: Twenty-five subjects with a history of differentiated thyroid carcinoma with > 10 years TSH-suppressive therapy with l-thyroxine completed the study. l-thyroxine dose was replaced by study medication containing l-thyroxine or l-thyroxine plus placebo. Medication was titrated to establish continuation of TSH suppression (low-TSH group, 13 patients) and euthyroidism (euthyroidism group, 12 patients). MEASUREMENTS: We evaluated glucose metabolism by glucose tolerance test and HOMA (IR) and lipid metabolism by lipid profile. In addition, we measured plasma concentrations of glucoregulatory hormones. RESULTS: At baseline, glucose tolerance, HOMA (IR), lipid profile and plasma concentrations of glucoregulatory hormones were within the normal range. No significant differences between the low TSH and euthyroidism group were observed. After 6 months, neither glucose nor lipid metabolism in the low TSH group were different from baseline values. CONCLUSION: In summary, glucose and lipid metabolism in patients with DTC and long-term subclinical hyperthyroidism in general are not affected. Restoration of euthyroidism in general does not affect glucose and lipid metabolism.

Adult↗

PubMed2004

Fortuitous phenomena: on complexity, pragmatic randomised controlled trials, and knowledge for evidence-based practice.

CONTEXT: Many of the interventions that nurses develop and implement are in themselves complex and have to operate in situations of irreducible complexity and uncertainty. MAIN ARGUMENT: This article argues that the primary means of generating knowledge for the evidence-based deployment of complex interventions should be the pragmatic randomised controlled trial. Randomised controlled trials represent the only research design to adequately deal with that which we know and (far more importantly) that which we do not. LITERARY METHOD: Using the example of practice development as an exemplar for complexity, and drawing on the objections often voiced as a response to calls to make use of randomised controlled trials in nursing and nursing research, the article presents a developmental framework and some methodological solutions to problems often encountered. CONCLUSION: Randomised controlled trials, whilst undoubtedly methodologically and strategically challenging, offer the most robust basis for developing primary research knowledge on the effects of complex interventions in nursing and their active components.

Benchmarking↗

PubMed1995

Controlled randomised trial of visual biofeedback versus muscle training without a visual display for intractable constipation.

Training to contract the abdominal muscles effectively and to relax the pelvic floor during defecation straining helps some patients with severe constipation. Hitherto all such training has used a visible or audible signal of sphincter muscle activity as a biofeedback method to assist in relaxation. A randomised controlled trial comparing the outcome of muscular training without any biofeedback device with the same training supplemented by an electromyographic (EMG) record visible to the patient is reported. Significant symptomatic improvement was noted and electromyographic measurements confirmed a decrease in pelvic floor muscle activity during defecation straining after treatment in both groups. The outcome was similar in the two treatment groups. Muscular coordination training using personal instruction and encouragement without a visual display is thus a potentially successful treatment suitable for outpatient use by paramedical personnel.

Adult↗

PubMed2004

Can foods with added soya-protein or fish-oil reduce risk factors for coronary disease? A factorial randomised controlled trial.

BACKGROUND AND AIMS: To develop functional foods which are capable of reducing key risk factors for coronary heart disease in an at risk population. The specific hypothesis tested here was that providing bread, cracker biscuits and snack bars fortified with DHA (long-chain omega 3) and soya-protein would havd a positive impact on cholesterol and blood pressure. METHODS AND RESULTS: A pragmatic, double-blind, factorial placebo-controlled randomised trial recruiting 213 middle-aged men and women with untreated elevated total cholesterol or blood pressure. The factors examined were the effect of giving supplies of bread, cereal bars and cracker biscuits fortified with 2 g fish oils (DHA, 22: 6n-3), or 25 g soya-protein (containing 50 mg of isoflavonoids) for five weeks. Primary and secondary outcomes included total, low-density and high-density cholesterol (HDL-C), and systolic and diastolic blood pressure. Compliance was assessed using biomarkers and food intake histories. DHA enriched foods increased HDL-C by 6.0% (95% CI 2.5%, 9.6%) but had no effect on total or low-density cholesterol or blood pressure. Overall, soya-protein did not influence any of the outcomes assessed. However, in women only, soya-protein increased systolic blood pressure by 5.9% (95% CI 1.73, 9.9%). CONCLUSIONS: Adding DHA (fish-oils) to staple foods might supplement existing methods to help reduce CVD morbidity and mortality. However, these findings highlight the importance of ensuring that functional foods do not present any harms to particular subgroups within a general population, if they are to be made freely available to consumers. This latter point requires further attention by the research community in relation to soya-protein.

Blood Pressure↗

PubMed2005

A randomised controlled trial assessing the efficacy and safety of repeated tegaserod therapy in women with irritable bowel syndrome with constipation.

BACKGROUND: It has been proposed that treatments for irritable bowel syndrome with constipation (IBS-C) should provide rapid symptomatic relief, be intermittent, and effective upon repeated use. AIMS: To evaluate the efficacy and safety of tegaserod on IBS symptoms, and its impact on quality of life and health economic measures. PATIENTS: Women (> or = 18 years of age) with IBS-C according to the Rome II criteria. METHODS: Prospective, double blind, placebo controlled, randomised trial. Women with IBS-C either received tegaserod 6 mg twice daily or placebo for one month. Patients with at least a partial response entered a treatment free interval. Upon symptom recurrence, tegaserod treated patients were re-randomised to tegaserod or placebo for an additional month. Primary efficacy variables were response (overall IBS symptoms and abdominal discomfort/pain) to first and repeated treatment. Analysis was by intention to treat. RESULTS: 2660 patients and 1191 patients were randomised for first and repeated treatment respectively. Tegaserod was superior to placebo for each primary efficacy variable (first treatment: 33.7% v 24.2% responders respectively for relief of IBS symptoms and 31.3% v 22.1% for relief of abdominal discomfort/pain; repeated treatment: 44.9% v 28.7%, and 42.4% v 27.1%, all p < 0.0001). Tegaserod was superior to placebo for every secondary efficacy variable (relief of abdominal discomfort/pain, bloating and constipation; stool frequency and consistency). A response to tegaserod was observed within the first treatment week. Tegaserod produced greater satisfaction, work productivity, and improved quality of life than placebo (p < 0.05). CONCLUSION: Tegaserod provides rapid and sustained relief of IBS-C symptoms both during first and repeated treatment.

Adolescent↗

PubMed2000

Randomised controlled trials of staged teaching for basic life support. 1. Skill acquisition at bronze stage.

We have investigated a method of teaching community CPR in three stages instead of in a single session. These have been designated bronze, silver, and gold stages. The first involves only opening of the airway and chest compression with back blows for choking, the second adds ventilation in a ratio of compressions to breaths of 50:5, and the third is a conversion to conventional CPR. In a controlled randomised trial of 495 trainees we compared the performance in tests immediately after instruction of those who had received a conventional course and those who had had the simpler bronze level tuition. The tests were based on video recordings of simulated resuscitation scenarios and the readouts from recording manikins. Differences occurred as a direct consequence of ventilation being required in one group and not the other, some variation probably followed from unforeseen minor changes in the way that instruction was given, whilst others may have followed from the greater simplicity in the new method of training. A careful approach was followed by slightly more trainees in the conventional group whilst appreciably more in the bronze group remembered to shout for help (44% vs. 71%). A clear advantage was also seen for bronze level training in terms of those who opened the airway as taught (35% vs. 56%), for checking breathing (66% vs. 88%), and for mentioning the need to phone for an ambulance (21% vs. 32%). Little difference was observed in correct or acceptable hand position between the conventional group who were given detailed guidance and the bronze group who were instructed only to push on the centre of the chest. The biggest differences related to the number of compressions given. The mean delay to first compression was 63 s and 34 s, and the mean duration of pauses between compressions was 16 s and 9 s, respectively. Average performed rates were similar in the two groups, but more in the conventional group compressed too slowly whereas more in the bronze group compressed too rapidly. Observations were made for only three cycles of compression, but extrapolating these to the 8 min often considered a watershed for chances of survival for victims of cardiac arrest, an average of 308 compressions would be expected from those using conventional CPR compared with 675 for those using bronze level CPR. The implications of this difference are discussed.

Adult↗

PubMedDate not supplied

Cardiovascular risk factors after antenatal exposure to betamethasone: 30-year follow-up of a randomised controlled trial.

BACKGROUND: Antenatal betamethasone treatment is widely used for the prevention of neonatal respiratory distress syndrome in preterm infants and substantially reduces neonatal mortality and morbidity. Fetal exposure to excess glucocorticoids has been proposed as one of the core mechanisms of the fetal origins of adult disease hypothesis. We assessed whether antenatal exposure to betamethasone for the prevention of neonatal respiratory distress syndrome affects cardiovascular risk factors at 30 years of age. METHODS: We followed up at age 30 years 534 individuals whose mothers participated in a double-blind, placebo-controlled, randomised trial of antenatal betamethasone for the prevention of neonatal respiratory distress syndrome. Mothers received two doses of betamethasone or placebo given by intramuscular injection 24 h apart. Follow-up assessments included anthropometry; measurement of blood pressure, blood lipids (after overnight fasting), and early morning cortisol levels; and a 75 g oral glucose tolerance test. FINDINGS: There were no differences between those exposed to betamethasone and to placebo in body size, blood lipids, blood pressure, plasma cortisol, prevalence of diabetes, or history of cardiovascular disease. After a 75 g oral glucose tolerance test, participants exposed to betamethasone had higher plasma insulin concentrations at 30 min (60.5 vs 52.0 mIU/L; ratio of geometric means 1.16 [95% CI 1.03 to 1.31], p=0.02) and lower glucose concentrations at 120 min (4.8 vs 5.1 mmol/L; difference -0.26 mmol/L [-0.53 to 0.00], p=0.05) than did those exposed to placebo. INTERPRETATION: Antenatal exposure to betamethasone might result in insulin resistance in adult offspring, but has no clinical effect on cardiovascular risk factors at 30 years of age. Thus, obstetricians should continue to use a single course of antenatal betamethasone for the prevention of neonatal respiratory distress syndrome.

Adult↗

PubMed1997

Improving uptake of breast screening in multiethnic populations: a randomised controlled trial using practice reception staff to contact non-attenders.

OBJECTIVES: To determine whether a two hour training programme for general practice reception staff could improve uptake in patients who had failed to attend for breast screening, and whether women from different ethnic groups benefited equally. DESIGN: Controlled trial, randomised by general practice. SETTING: Inner London borough of Newham. SUBJECTS: 2064 women aged 50-64 years who had failed to attend for breast screening. Women came from 26 of 37 eligible practices, 31% were white, 17% were Indian, 10% Pakistani, 14% black, 6% Bangladeshi, 1% Chinese, 4% were from other ethnic groups, and in 16% the ethnic group was not reported. MAIN OUTCOME MEASURES: Attendance for breast screening in relation to ethnic group in women who had not taken up their original invitation. RESULTS: Attendance in the intervention group was significantly better than in the control group (9% v 4%). The response was best in Indian women--it was 19% in the intervention group and 5% in the control group. CONCLUSIONS: This simple, low cost intervention improved breast screening rates modestly. Improvement was greatest in Indian women--probably because many practice staff shared their cultural and linguistic background. This intervention could be effective as part of a multifaceted strategy to improve uptake in areas with low rates.

Asia↗

PubMed2002

Efficacy of acupuncture in asthma: systematic review and meta-analysis of published data from 11 randomised controlled trials.

Contradictory results from randomised controlled trials of acupuncture in asthma suggest both a beneficial and detrimental effect. The authors conducted a formal systematic review and meta-analysis of all randomised clinical trials in the published literature that have compared acupuncture at real and placebo points in asthma patients. The authors searched for trials published in the period 1970-2000. Trials had to measure at least one of the following objective outcomes: peak expiratory flow rate, forced expiratory volume in one second (FEV1) and forced vital capacity. Estimates of the standarised mean difference, between acupuncture and placebo were computed for each trial and combined to estimate the overall effect. Hetereogeneity was investigated in terms of the characteristics of the individual studies. Twelve trials met the inclusion criteria but data from one could not be obtained. Individual patient data were available in only three. Standardised differences between means ranging from 0.071 to 0.133, in favour of acupuncture, were obtained. The overall effect was not conventionally significant and it corresponds to an approximate difference in FEV1 means of 1.7. After exploring hetereogenenity, it was found that studies where bronchoconstriction was induced during the experiment showed a conventionally significant effect. This meta-analysis did not find evidence of an effect of acupuncture in reducing asthma. However, the meta-analysis was limited by shortcomings of the individual trials, in terms of sample size, missing information, adjustment of baseline characteristics and a possible bias against acupuncture introduced by the use of placebo points that may not be completely inactive. There was a suggestion of preferential publication of trials in favour of acupuncture. There is an obvious need to conduct a full-scale randomised clinical trial addressing these limitations and the prognostic value of the aetiology of the disease.

Acupuncture Therapy↗

PubMed2002

Local warming and insertion of peripheral venous cannulas: single blinded prospective randomised controlled trial and single blinded randomised crossover trial.

OBJECTIVE: To determine whether local warming of the lower arm and hand facilitates peripheral venous cannulation. DESIGN: Single blinded prospective randomised controlled trial and single blinded randomised crossover trial. SETTING: Neurosurgical unit and haematology ward of university hospital. PARTICIPANTS: 100 neurosurgical patients and 40 patients with leukaemia who required chemotherapy. INTERVENTIONS: Neurosurgical patients' hands and forearms were covered for 15 minutes with a carbon fibre heating mitt. Patients were assigned randomly to active warming at 52 degrees C or passive insulation (heater not activated). The same warming system was used for 10 minutes in patients with leukaemia. They were assigned randomly to active warming or passive insulation on day 1 and given alternative treatment during the subsequent visit. MAIN OUTCOME MEASURES: PRIMARY: success rate for insertion of 18 gauge cannula into vein on back of hand. SECONDARY: time required for successful cannulation. RESULTS: In neurosurgical patients, it took 36 seconds (95% confidence interval 31 to 40 seconds) to insert a cannula in the active warming group and 62 (50 to 74) seconds in the passive insulation group (P=0.002). Three (6%) first attempts failed in the active warming group compared with 14 (28%) in the passive insulation group (P=0.008). The crossover study in patients with leukaemia showed that insertion time was reduced by 20 seconds (8 to 32, P=0.013) with active warming and that failure rates at first attempt were 6% with warming and 30% with passive insulation (P<0.001). CONCLUSIONS: Local warming facilitates the insertion of peripheral venous cannulas, reducing both time and number of attempts required. This may decrease the time staff spend inserting cannulas, reduce supply costs, and improve patient satisfaction.

Arm↗

PubMed1999

Early mobilisation versus immobilisation of surgically treated ankle fractures. Prospective randomised control trial.

In a randomised prospective controlled trial of 52 patients aged 16 to 65 we compared early non-weightbearing ankle mobilisation with ankle immobilisation following surgical treatment of bimalleolar ankle fractures. At 3 months there was no significant difference between the two groups in the range of ankle movements or pain. There was however a significant difference in the gait pattern with a higher proportion of cases in the early ankle mobilisation group having a symmetrical gait (P = 0.0001).

Adolescent↗

PubMed2002

Early and midterm outcome after off-pump and on-pump surgery in Beating Heart Against Cardioplegic Arrest Studies (BHACAS 1 and 2): a pooled analysis of two randomised controlled trials.

BACKGROUND: Although no randomised controlled trial has assessed the midterm effects of coronary-artery bypass surgery on the beating heart, this technique is being used in more and more patients. We did two randomised trials to compare the short-term morbidity associated with off-pump and on-pump myocardial revascularisation. Our aim was to pool the results to assess midterm outcomes. METHODS: From March, 1997, to November, 1999, we randomly allocated 200 patients to off-pump and 201 to on-pump coronary surgery. In Beating Heart Against Cardioplegic Arrest Study (BHACAS) 1, we excluded patients who had had myocardial infarction in the past month or who required grafting of the circumflex artery distal to the first obtuse marginal branch. In BHACAS 2, we included such patients. Primary outcomes were all-cause mortality and cardiac-related events at midterm follow-up (1-3 years). Analysis was by intention to treat. FINDINGS: Analyses of combined data from both trials showed the following risk differences with off-pump compared with on-pump surgery: atrial fibrillation -25% (95% CI -33% to -16%); chest infection -12% (-19% to -5%); inotropic requirement -18% (-25% to -10%); transfusion of red blood cells -31% (-41 to -21); and hospital stay longer than 7 days -13% (-21 to -5). Mean follow-up was 25 0 months (SD 9.1) for BHACAS 1 and 13.7 months (5 5) for BHACAS 2. Four (2%) of 200 patients in the off-pump groups died from any cause, compared with seven (3%) of 201 in the on-pump group (hazard ratio 0.57, 95% CI 0.17-1.96). 33 (17%) of 200 patients in the off-pump group died or had a cardiac-related event, compared with 42 (21%) of 201 in the on-pump group (0.78, 0 49-1.22). INTERPRETATION: Off-pump coronary surgery significantly lowers in-hospital morbidity without compromising outcome in the first 1-3 years after surgery compared with conventional on-pump coronary surgery.

Angina, Unstable↗

PubMed2005

Do early quadriceps exercises affect the outcome of ACL reconstruction? A randomised controlled trial.

A prospective, blinded, randomised controlled trial investigated the effectiveness of quadriceps exercises following anterior cruciate ligament reconstruction. A treatment group (Quadriceps exercise group) performed straight leg raises and isometric quadriceps contractions throughout the first two postoperative weeks, and a second group (No quadriceps exercise group) did not. A battery of outcome measures assessed subjects postoperatively at day one, two weeks, and one, three and six months. A total of 103 patients (Quadriceps exercise n = 48, No quadriceps exercise n = 55) commenced the study with 91 subjects available at final follow up (Quadriceps exercise n = 47, No quadriceps exercise n = 44). Performance of quadriceps exercises significantly improved a number of knee flexion and extension range of motion measurements (p = 0.01 to 0.04). No significant differences were found between the two groups at any postoperative period for quadriceps lag (p = 0.36), functional hop testing (p = 0.49 to 0.51), isokinetic quadriceps strength (p = 0.70 to 0.72), the majority of numerical analogue scores (p = 0.1 to 0.94) and Cincinnati scores (p = 0.10 to 0.84). Subjects performing quadriceps exercises reported significantly higher pain scores with exercise on the first postoperative day (p = 0.02). At six months postoperatively, the Quadriceps exercise subjects reported significantly more favourable Cincinnati scores for symptoms (p = 0.005) and problems with sport (p = 0.05). While average knee laxity was not significantly different between treatment groups over time (p = 0.27 to 0.94), quadriceps exercise performance was associated with a significantly lower incidence of abnormal knee laxity. Isometric quadriceps exercises and straight leg raises can be safely prescribed during the first two postoperative weeks and confer advantages for faster recovery of knee range of motion and stability. It remains to be proven whether the magnitude of differences between groups is clinically significant.

Adolescent↗

PubMed2002

The value of risks scores for predicting postoperative nausea and vomiting when used to compare patient group in a randomised controlled trial.

Whilst conducting a randomised controlled trial into the effects of combination anti-emetics, we endeavoured to confirm that our patient groups were matched using the predictive scoring systems for postoperative nausea and vomiting (PONV) and postoperative vomiting (POV) reported in the literature. One hundred and seventy-seven female patients attending for day case gynaecological surgery were studied and their individual risks of PONV and POV were calculated using four predictive models for PONV and two predictive models for POV. The scoring systems were then evaluated to see if agreement existed between them using the method described by Bland and Altman. Bias and 95% limits of agreement were calculated for each combination. Agreement between scoring systems was poor. As the scoring systems gave widely divergent predictions, we concluded that the predictive risk for PONV or POV would be dependent upon the scoring system chosen, thus limiting their usefulness in this role.

Adult↗

PubMed2004

Reducing utilisation of hospital services by case management: a randomised controlled trial.

A 12-month randomised controlled trial was conducted in Hong Kong to evaluate the effectiveness of case management provided to a group of home-dwelling, frail elderly patients (control group: n = 47; intervention group: n = 45) in terms of utilisation of hospital services by these patients. Significant reductions (significance at P </= 0.05) in mean total number of hospital bed-days (P < 0.001), mean total episodes of hospital admissions (P < 0.001), and mean total number of attendances at the outpatient department (P < 0.05) were observed when the baseline and post-intervention differences between the intervention and control groups were compared. The study demonstrated that utilisation of hospital services could be significantly reduced when a group of elderly patients and their caregivers received timely interventions and appropriate services through case management services.

Caregivers↗

PubMed1999

Pragmatic randomised controlled trials in psychiatry.

BACKGROUND: Randomised controlled trials (RCTs) are the most important method of evaluating new treatments and treatment policies. Despite this, there are relatively few large pragmatic RCTs in psychiatry. AIMS: To explore the main advantages of large pragmatic RCTs and the obstacles to performing them in psychiatry. METHOD: A narrative review of literature on pragmatic RCTs with examples drawn from psychiatry and other medical specialities. RESULTS: Obstacles to performing pragmatic RCTs in psychiatry include the complexity of psychiatric interventions, the complexity of outcomes used in psychiatry and the difficulties of blinding subjects and investigators to some psychiatric interventions. CONCLUSIONS: Researchers need to frame questions in a form that is relevant to clinicians and to convince clinicians to cooperate in simple large pragmatic trials.

Cluster Analysis↗

PubMed2002

Management of completely displaced metaphyseal fractures of the distal radius in children. A prospective, randomised controlled trial.

In a prospective, randomised controlled trial, 68 children who had a completely displaced metaphyseal fracture of the distal radius were treated either by manipulation (MUA) and application of an above-elbow cast alone or by the additional insertion of a percutaneous Kirschner (K-) wire. Full radiological follow-up to union was obtained in 65 children and 56 returned for clinical evaluation three months after injury. Maintenance of reduction was significantly better in the K-wire group and fewer follow-up radiographs were required. There was no significant difference in the clinical outcome measured three months after injury. Seven of 33 patients in the MUA group had to undergo a second procedure because of an unacceptable position compared with none of the 35 in the K-wire group (chi-squared test, p < 0.01). One patient in the K-wire group required exploration for recovery of a migrated wire. We conclude that the use of a percutaneous K-wire to augment the reduction of the fracture in children who have a completely displaced metaphyseal fracture of the distal radius is a safe and reliable way of maintaining alignment of the fracture.

Adolescent↗