Randomized controlled trial

About: Randomized controlled trial is a research topic. Over the lifetime, 119828 publications have been published within this topic receiving 4861808 citations. The topic is also known as: RCT & randomized control trial.

Is guided self-help as effective as face-to-face psychotherapy for depression and anxiety disorders? A systematic review and meta-analysis of comparative outcome studies.

Abstract: Background. Although guided self-help for depression and anxiety disorders has been examined in many studies, it is not clear whether it is equally effective as face-to-face treatments. Method. We conducted a meta-analysis of randomized controlled trials in which the effects of guided self-help on depression and anxiety were compared directly with face-to-face psychotherapies for depression and anxiety disorders. A systematic search in bibliographical databases (PubMed, PsycINFO, EMBASE, Cochrane) resulted in 21 studies with 810 participants. Results. The overall effect size indicating the difference between guided self-help and face-to-face psychotherapy at post-test was d=-0.02, in favour of guided self-help. At follow-up (up to 1 year) no significant difference was found either. No significant difference was found between the drop-out rates in the two treatments formats. Conclusions. It seems safe to conclude that guided self-help and face-to-face treatments can have comparable effects. It is time to start thinking about implementation in routine care.

Effectiveness of the diabetes education and self management for ongoing and newly diagnosed (DESMOND) programme for people with newly diagnosed type 2 diabetes: cluster randomised controlled trial

Abstract: Objective To evaluate the effectiveness of a structured group education programme on biomedical, psychosocial, and lifestyle measures in people with newly diagnosed type 2 diabetes Design Multicentre cluster randomised controlled trial in primary care with randomisation at practice level Setting 207 general practices in 13 primary care sites in the United Kingdom Participants 824 adults (55% men, mean age 595 years) Intervention A structured group education programme for six hours delivered in the community by two trained healthcare professional educators compared with usual care Main outcome measures Haemoglobin A 1c levels, blood pressure, weight, blood lipid levels, smoking status, physical activity, quality of life, beliefs about illness, depression, and emotional impact of diabetes at baseline and up to 12 months Main results Haemoglobin A 1c levels at 12 months had decreased by 149% in the intervention group compared with 121% in the control group After adjusting for baseline and cluster, the difference was not significant: 005% (95% confidence interval −010% to 020%) The intervention group showed a greater weight loss: −298 kg (95% confidence interval −354 to −241) compared with 186 kg (−244 to −128), P=0027 at 12 months The odds of not smoking were 356 (95% confidence interval 111 to 1145), P=0033 higher in the intervention group at 12 months The intervention group showed significantly greater changes in illness belief scores (P=0001); directions of change were positive indicating greater understanding of diabetes The intervention group had a lower depression score at 12 months: mean difference was −050 (95% confidence interval −096 to −004); P=0032 A positive association was found between change in perceived personal responsibility and weight loss at 12 months (β=012; P=0008) Conclusion A structured group education programme for patients with newly diagnosed type 2 diabetes resulted in greater improvements in weight loss and smoking cessation and positive improvements in beliefs about illness but no difference in haemoglobin A 1c levels up to 12 months after diagnosis Trial registration Current Controlled Trials ISRCTN17844016

Effectiveness of collaborative care for older adults with Alzheimer disease in primary care: a randomized controlled trial.

Abstract: ContextMost older adults with dementia will be cared for by primary care physicians, but the primary care practice environment presents important challenges to providing quality care.ObjectiveTo test the effectiveness of a collaborative care model to improve the quality of care for patients with Alzheimer disease.Design, Setting, and PatientsControlled clinical trial of 153 older adults with Alzheimer disease and their caregivers who were randomized by physician to receive collaborative care management (n = 84) or augmented usual care (n = 69) at primary care practices within 2 US university-affiliated health care systems from January 2002 through August 2004. Eligible patients (identified via screening or medical record) met diagnostic criteria for Alzheimer disease and had a self-identified caregiver.InterventionIntervention patients received 1 year of care management by an interdisciplinary team led by an advanced practice nurse working with the patient's family caregiver and integrated within primary care. The team used standard protocols to initiate treatment and identify, monitor, and treat behavioral and psychological symptoms of dementia, stressing nonpharmacological management.Main Outcome MeasuresNeuropsychiatric Inventory (NPI) administered at baseline and at 6, 12, and 18 months. Secondary outcomes included the Cornell Scale for Depression in Dementia (CSDD), cognition, activities of daily living, resource use, and caregiver's depression severity.ResultsInitiated by caregivers' reports, 89% of intervention patients triggered at least 1 protocol for behavioral and psychological symptoms of dementia with a mean of 4 per patient from a total of 8 possible protocols. Intervention patients were more likely to receive cholinesterase inhibitors (79.8% vs 55.1%; P = .002) and antidepressants (45.2% vs 27.5%; P = .03). Intervention patients had significantly fewer behavioral and psychological symptoms of dementia as measured by the total NPI score at 12 months (mean difference, −5.6; P = .01) and at 18 months (mean difference, −5.4; P = .01). Intervention caregivers also reported significant improvements in distress as measured by the caregiver NPI at 12 months; at 18 months, caregivers showed improvement in depression as measured by the Patient Health Questionnaire-9. No group differences were found on the CSDD, cognition, activities of daily living, or on rates of hospitalization, nursing home placement, or death.ConclusionsCollaborative care for the treatment of Alzheimer disease resulted in significant improvement in the quality of care and in behavioral and psychological symptoms of dementia among primary care patients and their caregivers. These improvements were achieved without significantly increasing the use of antipsychotics or sedative-hypnotics.Trial Registrationclinicaltrials.gov Identifier: NCT00246896

Statin Safety: A Systematic Review

Abstract: A systematic review of cohort studies, randomized trials, voluntary notifications to national regulatory authorities, and published case reports was undertaken to assess the incidence and characteristics of adverse effects in patients treated with 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors, or statins. For statins other than cerivastatin, the incidence of rhabdomyolysis in 2 cohort studies was 3.4 (1.6 to 6.5) per 100,000 person-years, an estimate supported by data from 20 randomized controlled trials. Case fatality was 10%. Incidence was about 10 times greater when gemfibrozil was used in combination with statins. Incidence was higher (4.2 per 100,000 person-years) with lovastatin, simvastatin, or atorvastatin (which are oxidized by cytochrome P450 3A4 [CYP3A4], which is inhibited by many drugs) than pravastatin or fluvastatin (which are not oxidized by CYP3A4). In persons taking simvastatin, lovastatin, or atorvastatin, 60% of cases involved drugs known to inhibit CYP3A4 (especially erythromycin and azole antifungals), and 19% involved fibrates, principally gemfibrozil. The incidence of myopathy in patients treated with statins, estimated from cohort studies supported by randomized trials, was 11 per 100,000 person-years. For liver disease, randomized trials reported fewer hepatobiliary disorders in patients allocated statins than in those allocated placebo. The notification rate of liver failure to regulatory authorities was about 1 per million person-years of statin use. Randomized trials show no excess of renal disease or proteinuria in statin-allocated participants, and the decline in glomerular filtration rate was smaller with statins than with placebo. Evidence from 4 cohort studies and case reports suggests that statins cause peripheral neuropathy, but the attributable risk is small (12 per 100,000 person-years). No change in cognitive function was found in randomized trials of statins in elderly patients.