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 1,801 records · Page 100Linked to original sources

PubMed1996

A randomised controlled trial of different intensities of physiotherapy and different goal-setting procedures in 44 children with cerebral palsy.

Forty-four children aged 3 to 11 years with quadriplegic cerebral palsy were prospectively stratified and randomised into four treatment groups. The acquisition of motor skills was assessed in a 2 x 2 factorial design using the Gross Motor Function Measure. The two factors were conventional amounts of physiotherapy vs intensive amounts of physiotherapy, and the use of broad, generalised aims vs the use of specific measurable goals directed at motor skill acquisition. 82% of the children improved. Over the two-week period, intensive physiotherapy produced a slightly greater effect than conventional physiotherapy but the factor more strongly associated with increased motor skill acquisition was the use of specific measurable goals.

Adolescent↗

PubMed1997

Influence of fine-bore catheter length on infusion thrombophlebitis in peripheral intravenous nutrition: a randomised controlled trial.

Previous studies indicated that the risk of thrombophlebitis associated with continuous infusion of intravenous nutrition (IVN) via peripheral veins was reduced when fine-bore catheters, inserted to 15 cm, were used in place of standard intravenous cannulas. An explanation has not been identified, but may be owing to the greater length of the catheters. A randomised controlled study was performed in which a standard nutritional solution was infused via 22G polyurethane catheters inserted to a length of either 5 cm or 15 cm. Catheters were reviewed twice each day and removed when complications occurred, or when IVN was no longer required. There was no significant difference in median time to thrombophlebitis or extravasation, or in daily risk of thrombophlebitis, between insertion lengths. Survival proportions were similar for each length at all times. Catheters inserted into cephalic veins were more prone to thrombophlebitis or extravasation (nine episodes, 14 catheters) than catheters inserted into basilic veins (five episodes, 24 catheters, P = 0.009). The survival proportion was at all times greater when catheter tips lay in basilic veins. Thus, the risk of thrombophlebitis or extravasation was not influenced by the length of catheter within the vein. However, the vein in which the catheter tip lay appeared to influence the development of morbidity.

Adult↗

PubMed2001

Involving consumers in designing, conducting, and interpreting randomised controlled trials: questionnaire survey.

OBJECTIVE: To assess the extent to which consumers are involved in the work of clinical trial coordinating centres in the United Kingdom and the nature of consumers' involvement in randomised trials coordinated by these centres. DESIGN: National surveys using structured questionnaires with some open ended sections. SETTING: 103 clinical trial coordinating centres in the United Kingdom identified through a database assembled in 1997 by the NHS clinical trials adviser. PARTICIPANTS: Named contacts at 62 coordinating centres and investigators in 60 trials that were identified as involving consumers. MAIN OUTCOME MEASURES: Number of coordinating centres and number of trials in which consumers were involved and the nature of consumers' involvement. RESULTS: Of the 62 eligible centres, 23 reported that consumers had already been involved in their work, and most respondents were positive about this involvement. 17 centres planned to involve consumers. 15 centres had no plans to involve consumers, but only four of these considered such involvement irrelevant. Responses from investigators about the 48 individual trials were mostly positive, with respondents commenting that input from consumers had helped refine research questions, improve the quality of patient information, and make the trial more relevant to the needs of patients. CONCLUSIONS: Consumer involvement in the design and conduct of controlled trials seems to be growing and seems to be welcomed by most researchers. Such involvement seems likely to improve the relevance to consumers of the questions addressed and the results obtained in controlled trials.

Humans↗

PubMed2001

Results of a 10 week community based strength and balance training programme to reduce fall risk factors: a randomised controlled trial in 65-75 year old women with osteoporosis.

OBJECTIVE: To test the efficacy of a community based 10 week exercise intervention to reduce fall risk factors in women with osteoporosis. METHODS: Static balance was measured by computerised dynamic posturography (Equitest), dynamic balance by timed figure of eight run, and knee extension strength by dynamometry. Subjects were randomised to exercise intervention (twice weekly Osteofit classes for 10 weeks) or control groups. RESULTS: The outcome in 79 participants (39 exercise, 40 control) who were available for measurement 10 weeks after baseline measurement is reported. After confounding factors had been controlled for, the exercise group did not make significant gains compared with their control counterparts, although there were consistent trends toward greater improvement in all three primary outcome measures. Relative to the change in control subjects, the exercise group improved by 2.3% in static balance, 1.9% in dynamic balance, and 13.9% in knee extension strength. CONCLUSIONS: A 10 week community based physical activity intervention did not significantly reduce fall risk factors in women with osteoporosis. However, trends toward improvement in key independent risk factors for falling suggest that a study with greater power may show that these variables can be improved to a level that reaches statistical significance.

Accidental Falls↗

PubMed2004

High dose caffeine citrate for extubation of preterm infants: a randomised controlled trial.

OBJECTIVE: To compare two dosing regimens for caffeine citrate in the periextubation period for neonates born at less than 30 weeks gestation in terms of successful extubation and adverse effects. DESIGN: A multicentre, randomised, double blind, clinical trial. SETTING: Four tertiary neonatal units within Australia. PATIENTS: Infants born less than 30 weeks gestation ventilated for more than 48 hours. INTERVENTIONS: Two dosing regimens of caffeine citrate (20 v 5 mg/kg/day) for periextubation management. Treatment started 24 hours before a planned extubation or within six hours of an unplanned extubation. MAIN OUTCOME MEASURE: Failure to extubate within 48 hours of caffeine loading or reintubation and ventilation or doxapram within seven days of caffeine loading. RESULTS: A total of 234 neonates were enrolled. A significant reduction in failure to extubate was shown for the 20 mg/kg/day dosing group (15.0% v 29.8%; relative risk 0.51; 95% confidence interval (CI) 0.31 to 0.85; number needed to treat 7 (95% CI 4 to 24)). A significant difference in duration of mechanical ventilation was shown for infants of less than 28 weeks gestation receiving the high dose of caffeine (mean (SD) days 14.4 (11.1) v 22.1 (17.1); p = 0.01). No difference in adverse effects was detected in terms of mortality, major neonatal morbidity, death, or severe disability or general quotient at 12 months. CONCLUSIONS: This trial shows short term benefits for a 20 mg/kg/day dosing regimen of caffeine citrate for neonates born at less than 30 weeks gestation in the periextubation period, without evidence of harm in the first year of life.

Caffeine↗

PubMed2002

A randomised controlled trial of endoscopic sphincterotomy in acute cholangitis without common bile duct stones.

BACKGROUND: Biliary decompression with endoscopic sphincterotomy (EPT) is beneficial in patients with biliary obstruction due to common bile duct (CBD) stones. However, it is not known whether EPT with decompression of the bile duct is beneficial in patients with acute cholangitis and gall bladder stones but without evidence of CBD stones. AIM: A randomised controlled study to assess the effect of EPT on the outcome of patients suffering from acute cholangitis with gall bladder stones but with no CBD stones on initial endoscopic retrograde cholangiopancreatography. PATIENTS: A total of 111 patients were recruited into the study. METHODS AND RESULTS: Fifty patients were randomised to receive EPT while 61 patients received no endoscopic intervention. There was a significant difference in the duration of fever in the EPT and non-EPT groups (mean (SD): 3.2 (2.2) days v 4.3 (2.1) days; p<0.001). Duration of hospital stay was also shorter in the EPT group than in the non-EPT group (mean (SD): 8.1 (3.0) v 9.1 (3.2) days; p=0.04). Patients were followed up for a mean (SD) of 42.4 (11.1) months. Twenty three patients (20.3%) developed recurrent acute cholangitis (RAC): 14 patients (12.6%) in the EPT group and nine patients (8.1%) in the non-EPT group (p=0.09). CONCLUSION: EPT in patients with acute cholangitis without CBD stones decreased the duration of acute cholangitis and reduced hospital stay but it did not decrease the incidence of RAC.

Acute Disease↗

PubMed2006

Autologous bone marrow-derived stem-cell transfer in patients with ST-segment elevation myocardial infarction: double-blind, randomised controlled trial.

BACKGROUND: The benefit of reperfusion therapies for ST-elevation acute myocardial infarction (STEMI) is limited by post-infarction left-ventricular (LV) dysfunction. Our aim was to investigate the effect of autologous bone marrow-derived stem cell (BMSC) transfer in the infarct-related artery on LV function and structure. METHODS: We did a randomised, double-blind, placebo-controlled study in 67 patients from whom we harvested bone marrow 1 day after successful percutaneous coronary intervention for STEMI. We assigned patients optimum medical treatment and infusion of placebo (n=34) or BMSC (n=33). Our primary endpoint was the increase in LV ejection fraction and our secondary endpoints were change in infarct size and regional LV function at 4 months' follow-up, all assessed by MRI. We assessed changes in myocardial perfusion and oxidative metabolism with serial 1-[11C]acetate PET. Analyses were per protocol. This study is registered with , number NCT00264316. FINDINGS: Mean global LV ejection fraction 4 days after percutaneous coronary intervention was 46.9% (SD 8.2) in controls and 48.5% (7.2) in BMSC patients, and increased after 4 months to 49.1% (10.7) and 51.8% (8.8; OR for treatment effect 1.036, 95% CI 0.961-1.118, p=0.36). Compared with placebo infusion, BMSC transfer was associated with a significant reduction in myocardial infarct size (BMSC treatment effect 28%, p=0.036) and a better recovery of regional systolic function. Myocardial perfusion and metabolism increased similarly in both groups. We noted no complications associated with BMSC transfer and all but one patient in the BMSC group completed the 4 months' follow-up. INTERPRETATION: Intracoronary transfer of autologous bone marrow cells within 24 h of optimum reperfusion therapy does not augment recovery of global LV function after myocardial infarction, but could favourably affect infarct remodelling.

Angioplasty, Balloon, Coronary↗

PubMed2002

Guideline-based early rehabilitation after myocardial infarction. A pragmatic randomised controlled trial.

OBJECTIVES: To determine the effectiveness of individualised educational behavioural treatment delivered by cardiac nurses in hospital compared to usual care for patients following acute myocardial infarction. METHODS: One hundred and fourteen consecutive patients were randomised to receive the intervention or usual care. Outcome assessment was by self-report questionnaire (the Hospital Anxiety and Depression Scale and Dartmouth COOP Health Status), interview at 1 month, and self-report at 3 and 12 months. The primary outcome was improvement in the Dartmouth COOP total score from baseline to 3 months. RESULTS: Four patients needed to be treated to give an additional patient with improvement in health status at 3 months (number needed to treat [NNT] 4, 95% confidence intervals [CIs] 3 to 12). The intervention group were more confident about returning to activities 1 month after discharge from hospital. Treated patients had fewer further treatment needs. CONCLUSIONS: An individualised educational behavioural treatment delivered by cardiac nurses in hospital may have substantial benefits. A large-scale pragmatic RCT is needed.

Activities of Daily Living↗

PubMedDate not supplied

Screening of lung cancer with low dose spiral CT: results of a three year pilot study and design of the randomised controlled trial ''Italung-CT''.

PURPOSE: To report the results of a three-year observational pilot study of lung cancer screening with low dose computed tomography (CT) and to present the study design of a randomised clinical trial named as ''Italung-CT''. MATERIALS AND METHODS: Sixty (47 males and 13 females, mean age 64+/-4.5 years) heavy smokers (at least 20 packs-year) underwent three low-dose spiral CT screening tests one year apart on a single slice or multislice CT scanner. Indeterminate nodules were managed according to the recommendations of the Early Lung Cancer Action Project. RESULTS: and Indeterminate nodules were observed in 33 (55%) of the subjects (60% at the baseline screening test, 24% at the first annual test and 16% at the second annual test). The size of the largest indeterminate nodule was <5 mm in diameter in 20 subjects, 10 of whom showed the nodule at the baseline test. Forty-five subjects (75%) completed the first annual test and 42 (70%) the second annual test. One (1.6%) prevalent lung cancer (adenosquamous carcinoma) and one (2.2%) incident lung cancer (small cell cancer at the first annual examination) were observed, as well as a pulmonary localisation of Hodgkin's lymphoma (at the second annual test). In addition, one subject underwent lung surgery for a chondromatous hamartoma. CONCLUSIONS: The results of the pilot study are substantially in line with those of other observational studies of greater sample size. This justifies optimism about the reliability of the results in the screened arm of the ''Italung CT'' trial which has just begun.

Female↗

PubMed2006

Immediate computed tomography or admission for observation after mild head injury: cost comparison in randomised controlled trial.

OBJECTIVE: To compare the costs of immediate computed tomography during triage for admission with those of observation in hospital in patients with mild head injury. DESIGN: Prospective cost effectiveness analysis within a multicentre, pragmatic randomised trial. SETTING: 39 acute hospitals in Sweden PARTICIPANTS: 2602 patients (aged > or = 6) with mild head injury. INTERVENTIONS: Immediate computed tomography or admission for observation. MAIN OUTCOME MEASURES: Direct and indirect costs related to the mild head injury during the acute and three month follow-up period. RESULTS: Outcome after three months was similar for both strategies (non-significantly in favour of computed tomography). For the acute stage and complications, the cost was 461 euros (314 pounds sterling, 582 dollars) per patient in the computed tomography group and 677 euros (462 pounds sterling, 854 dollars) in the observation group; an average of 32% less in the computed tomography group (216 euros, 95% confidence interval -272 to -164; P < 0.001). Sensitivity analysis showed that computed tomography was the most cost effective strategy under a broad range of assumptions. After three months, total costs were 718 euros and 914 euros per patient-that is, 196 euros less in the computed tomography group (- 281 to - 114; P < 0.001). The lower cost of the computed tomography strategy at the acute stage thus remained unchanged during follow-up. CONCLUSION: Patients with mild head injury attending an emergency department can be managed more cost effectively with computed tomography rather than admission for observation in hospital. TRIAL REGISTRATION: ISRCTN81464462.

Adolescent↗

PubMed1997

Randomised controlled trial of growth effect of hydrocortisone in congenital adrenal hyperplasia.

The influence of 15 or 25 mg/m2 of daily oral hydrocortisone with fludrocortisone 0.1 mg/day on growth and laboratory findings was evaluated in a prospective randomised crossover trial over 12 months in 26 children with 21-hydroxylase deficiency. Nine non-salt losers had fludrocortisone stopped for a further six month period. Height velocity was significantly decreased during treatment with 25 mg/m2 as compared with 15 mg/m2. This was the most sensitive indicator of corticosteroid treatment excess. A dose dependent effect upon plasma concentrations of 17-hydroxyprogesterone, testosterone, and androstenedione was found but increased values were still detected in more than half of the determinations made during the 25 mg/m2 period. Height velocity and 17-hydroxyprogesterone concentrations were positively correlated. Growth hormone response to clonidine stimulation and insulin-like growth factor-1 concentrations were both within reference values and there was no difference between treatment periods. Withdrawal of fludrocortisone did not result in any difference for the non-salt losers. It was concluded that 25 mg/m2 of hydrocortisone depressed growth in children with congenital adrenal hyperplasia, and that full suppression, or even normalisation, of plasma concentrations of 17-hydroxyprogesterone and androgens should not be considered a treatment goal, but instead an indication of corticosteroid treatment excess.

17-alpha-Hydroxyprogesterone↗

PubMed2005

Falls and health status in elderly women following first eye cataract surgery: a randomised controlled trial.

BACKGROUND/AIM: A third of elderly people fall each year. Poor vision is associated with increased risk of falls. The authors aimed to determine if first eye cataract surgery reduces the risk of falling, and to measure associated health gain. METHODS: 306 women aged over 70, with cataract, were randomised to expedited (approximately 4 weeks) or routine (12 months wait) surgery. Falls were ascertained by diary, with follow up every 3 months. Health status was measured after 6 months. RESULTS: Visual function improved in the operated group (corrected binocular acuity improved by 0.25 logMAR units; 8% had acuity worse than 6/12 compared with 37% of controls). Over 12 months of follow up, 76 (49%) operated participants fell at least once, and 28 (18%) fell more than once. 69 (45%) unoperated participants fell at least once, 38 (25%) fell more than once. Rate of falling was reduced by 34% in the operated group (rate ratio 0.66, 95% confidence interval 0.45 to 0.96, p = 0.03). Activity, anxiety, depression, confidence, visual disability, and handicap all improved in the operated group compared with the control group. Four participants in the operated group had fractures (3%), compared with 12 (8%) in the control group (p = 0.04). CONCLUSION: First eye cataract surgery reduces the rate of falling, and risk of fractures and improves visual function and general health status.

Accidental Falls↗

PubMed2000

Effect of community-based peer counsellors on exclusive breastfeeding practices in Dhaka, Bangladesh: a randomised controlled trial [see commments].

BACKGROUND: Most mothers breastfeed in Bangladesh, but they rarely practise exclusive breastfeeding. Hospital-based strategies for breastfeeding promotion cannot reach them because about 95% have home deliveries. We postulated that with the intervention of trained peer counsellors, mothers could be enabled to breastfeed exclusively for the recommended duration of 5 months. METHODS: 40 adjacent zones in Dhaka were randomised to intervention or control groups. Women were enrolled during the last trimester of pregnancy between February and December, 1996. In the intervention group, 15 home-based counselling visits were scheduled, with two visits in the last trimester, three early postpartum (within 48 h, on day 5, between days 10 and 14), and fortnightly thereafter until the infant was 5 months old. Peer counsellors were local mothers who received 10 days' training. FINDINGS: 363 women were enrolled in each group. Peer counselling significantly improved breastfeeding practices. For the primary outcome, the prevalence of exclusive breastfeeding at 5 months was 202/228 (70%) for the intervention group and 17/285 (6%) for the control group (difference=64%; 95% CI 57%-71%, p>0.0001). For the secondary outcomes, mothers in the intervention group initiated breastfeeding earlier than control mothers and were less likely to give prelacteal and postlacteal foods. At day 4, significantly more mothers in the intervention group breastfed exclusively than controls. INTERPRETATION: Peer counsellors can effectively increase the initiation and duration of exclusive breastfeeding. We recommend incorporation of peer counsellors in mother and child health programmes in developing countries.

Adolescent↗

PubMed1998

Evaluation of adjuvant psychological therapy in patients with testicular cancer: randomised controlled trial.

OBJECTIVE: To determine the efficacy of adjuvant psychological therapy in patients with testicular cancer and to compare the characteristics and psychosocial outcomes of men who agreed to participate with those who declined to participate in a randomised trial of psychological intervention. DESIGN: Newly diagnosed patients were asked to participate in a randomised trial of psychological support compared with standard medical care. Participants and non-participants completed self assessment questionnaires at baseline and at 2, 4 and 12 months. SETTING: Testicular Tumour Unit of the Royal Marsden Hospital. SUBJECTS: 73 of 184 (40%) eligible patients agreed to enter the randomised trial (participants) and 81 (44%) declined to participate but agreed to complete further assessments (non-participants). 30 patients wanted no further contact with the researchers. OUTCOME MEASURES: Hospital anxiety and depression scale, psychosocial adjustment to illness scale, Rotterdam symptom checklist, mental adjustment to cancer scale. Only scores on the hospital anxiety and depression scale are reported for evaluating treatment efficacy. RESULTS: 111 of 184 (60%) eligible men declined to participate in the trial. Patients with stage I disease were most likely to refuse to participate. A patient was less likely to participate if he had low volume disease and was receiving no further treatment. Likelihood of participation was associated with stage of disease and with type of primary treatment (P < 0.001 for heterogeneity). Patients with early stage disease (P < 0.001) and fewer physical symptoms (P < 0.001) were less likely to participate. Psychosocial factors associated with participation included anxious preoccupation regarding disease (P = 0.01). There were no differences in outcome between participants and non-participants during follow up. Patients seemed to gain little benefit from adjuvant psychological therapy. At 2 months change from baseline favoured the treated group in the anxiety subscale (mean difference between groups -1.41 (95% confidence interval -2.86 to 0.03)). This was not sustained when adjusted for factors related to the disease. By 12 months change from baseline seemed to favour the control group (mean difference between groups 1.66 (-0.18 to 3.50)). CONCLUSIONS: Patients with testicular cancer seem to have considerable coping abilities. Those who declined to participate in the trial differed from those who participated. Those who agreed to participate may comprise the clinical group who perceive a need for psychological support. No evidence was found to indicate a need for routinely offering adjuvant psychological therapy.

Adolescent↗

PubMed2004

Cure of Helicobacter pylori infection in patients with reflux oesophagitis treated with long term omeprazole reverses gastritis without exacerbation of reflux disease: results of a randomised controlled trial.

BACKGROUND: Helicobacter pylori gastritis may progress to glandular atrophy and intestinal metaplasia, conditions that predispose to gastric cancer. Profound suppression of gastric acid is associated with increased severity of H pylori gastritis. This prospective randomised study aimed to investigate whether H pylori eradication can influence gastritis and its sequelae during long term omeprazole therapy for gastro-oesophageal reflux disease (GORD). METHODS: A total of 231 H pylori positive GORD patients who had been treated for > or =12 months with omeprazole maintenance therapy (OM) were randomised to either continuation of OM (OM only; n = 120) or OM plus a one week course of omeprazole, amoxycillin, and clarithromycin (OM triple; n = 111). Endoscopy with standardised biopsy sampling as well as symptom evaluation were performed at baseline and after one and two years. Gastritis was assessed according to the Sydney classification system for activity, inflammation, atrophy, intestinal metaplasia, and H pylori density. RESULTS: Corpus gastritis activity at entry was moderate or severe in 50% and 55% of the OM only and OM triple groups, respectively. In the OM triple group, H pylori was eradicated in 90 (88%) patients, and activity and inflammation decreased substantially in both the antrum and corpus (p<0.001, baseline v two years). Atrophic gastritis also improved in the corpus (p<0.001) but not in the antrum. In the 83 OM only patients with continuing infection, there was no change in antral and corpus gastritis activity or atrophy, but inflammation increased (p<0.01). H pylori eradication did not alter the dose of omeprazole required, or reflux symptoms. CONCLUSIONS: Most H pylori positive GORD patients have a corpus predominant pangastritis during omeprazole maintenance therapy. Eradication of H pylori eliminates gastric mucosal inflammation and induces regression of corpus glandular atrophy. H pylori eradication did not worsen reflux disease or lead to a need for increased omeprazole maintenance dose. We therefore recommend eradication of H pylori in GORD patients receiving long term acid suppression.

Adult↗

PubMed2004

Individualised unsupervised exercise training in adults with cystic fibrosis: a 1 year randomised controlled trial.

BACKGROUND: Short term studies of exercise training have shown benefits in cystic fibrosis. Transferring exercise programmes to the community and sustaining them long term is a challenge for the patient. The effectiveness of an individualised unsupervised home based exercise programme was examined in adults with cystic fibrosis over a 1 year period. METHODS: Subjects were randomised to undertake three sessions per week of upper and lower body exercise based on individualised preferences (n = 30) or to a control group (n = 18). They were evaluated at baseline and at 12 months. The primary outcome measure was improved fitness as assessed by change in blood lactate concentration at the end of an identical constant work rate for both arm and leg ergometric testing. Secondary outcome measurements were heart rate and pulmonary function. RESULTS: For leg exercise, significant differences were seen at 12 months between the active and control groups in the mean (SE) change in blood lactate levels (-0.38 (0.23) mmol/l v 0.45 (0.25) mmol/l, p<0.05) and heart rate (-4.8 (2.5) bpm v 3.4 (2.5) bpm, p<0.05), confirming a training effect. For arm ergometry there was no change in lactate levels at 12 months but there was a significant difference in forced vital capacity (46 (72) ml v -167 (68) ml, p<0.05). CONCLUSIONS: A training effect, as measured by a reduction in lactate levels and heart rate, can be achieved with unsupervised individualised home exercise in adults with cystic fibrosis. A benefit to pulmonary function was observed and together these findings suggest that exercise programmes should be encouraged as an important component of care in cystic fibrosis.

Adult↗

PubMed2004

Strategies for the introduction and implementation of a guideline for the treatment of type 2 diabetics by general practitioners (GPs) of the Lazio region of Italy (IMPLEMEG study): protocol for a cluster randomised controlled trial [ISRCTN80116232].

BACKGROUND: Despite broad agreement on the necessity to improve quality of diabetic care through implementation of clinical guidelines, in Italy many people with diabetes still lack adequate care in general practice. In addition there is little evidence to support the choice of implementation strategies, especially in the Lazio region (central Italy), where comparative studies among general practitioners (GPs) are uncommon. The primary objective of the study is to assess the effectiveness of different strategies for the implementation of an evidence-based guideline for the management of non-complicated type 2 diabetes mellitus (DM) among GPs of the Lazio region. METHODS/DESIGN: Three-arm cluster-randomised trial (C-RCT). 252 GPs were randomised either to arm 1 (comprising a training module and administration of the guideline), or to arm 2 (administration of guideline without training), or to arm 3 (control arm), continuing current practice. Arm 1 participants attended a two-day course with CME credits. Data collection will be performed using current information systems. Patients' health data was also collected to describe diabetic populations cared for by GP participants. Process outcomes will be measured at the patient level and at the cluster level one year after the intervention. We will assess GPs' adherence to guideline recommendations for diabetes management relative to: 1) pharmacological management of diabetes; 2) pharmacological management of cardiovascular risk factors (hypertension and dislypidaemia); 3) measurement of glycosilated haemoglobin as the principal indicator of glycaemic control; 4) micro- and macrovascular complications assessment tests. Outcomes will be expressed as proportions of patients cared for by GPs who will have prescriptions of drugs, requests for tests and for outpatient appointment visits. To estimate the efficiency of resource use associated with the intervention a cost-effectiveness analysis will be carried out. The design of the study is based on three Cochrane and one Health Technology Assessment systematic reviews of guideline dissemination and implementation strategies.

Age Factors↗

PubMed2005

Effectiveness of systematic monitoring of rheumatoid arthritis disease activity in daily practice: a multicentre, cluster randomised controlled trial.

OBJECTIVE: To test the efficacy of standardised monitoring using the disease activity index DAS28 versus usual care on disease modifying antirheumatic drug (DMARD) prescription and disease activity in rheumatoid arthritis. METHODS: A 24 week cluster randomised trial. Rheumatology outpatient centres were randomised to systematic monitoring of disease activity using the DAS28 (12 centres, 205 patients) or usual care (12 centres, 179 patients). The aim for the DAS group was to reach a DAS28 score of < or =3.2 by changes in DMARD treatment, at the discretion of the rheumatologist and the patient. RESULTS: At baseline, disease activity was the same in both groups, with an overall mean (SD) DAS28 of 4.5 (1.2); 13% of the patients had a DAS28 of < or =3.2. At 24 weeks, 31% of patients in the DAS group had a DAS28 < or =3.2, while in the usual care centres this was 16% (p = 0.028). DMARDs were changed on average in 18% of visits in the DAS centres; in the 12 usual care centres they were changed on 8% of the visits (p = 0.013). The doses of methotrexate, sulfasalazine, and corticosteroids appeared to be higher in the DAS centres than in the usual care centres, but the differences were not significant. CONCLUSIONS: In daily practice, systematic monitoring of disease activity in rheumatoid arthritis may lead to more changes in DMARD treatment, resulting in a larger number of patients with low disease activity.

Adrenal Cortex Hormones↗

Refine your search to explore more results.