BACKGROUND There is growing interest in conducting clinical and cluster randomized trials through electronic health records. This paper reports on the methodological issues identified during the implementation of two cluster randomized trials using the electronic health records of the Clinical Practice Research Datalink (CPRD). METHODS Two trials were completed in primary care: one aimed to r...

BACKGROUND Many patients with diabetes mellitus (DM) require a combination of antidiabetic drugs with complementary mechanisms of action to lower their hemoglobin A1c levels to achieve therapeutic targets and reduce the risk of cardiovascular complications. Linagliptin is a novel member of the dipeptidyl peptidase-4 (DPP-4) inhibitor class of antidiabetic drugs. DPP-4 inhibitors increase incret...

OBJECTIVE To evaluate the reports' qualities which are about randomized controlled trials (RCTs) of acupuncture treatment on Mild Cognitive Impairment (MIC). METHODS Nine databases including the Cochrane Central Register of Controlled Trials (CENTRAL,2010), PUBMED (1984-5/2010), EMbase (1984-5/2010), MEDLINE (1984-5/2010), CINAL (1984-5/2010), China National Knowledge Infrastructure (CNKI, 19...

BACKGROUND To test the reliability, sensitivity to change in biomarkers associated with disease progression and response to treatment, and clinical meaningfulness of the Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) in patients with hepatobiliary carcinoma. PATIENTS AND METHODS One hundred and fifty-eight patients diagnosed with hepatobiliary carcinoma were prospectively st...

UNLABELLED Haemodialysis is a form of renal replacement therapy but is a catabolic process that not only filters toxins but is also known to lead to amino acid losses. Patients with chronic kidney disease often have a poor appetite and this in combination with limited dietary intake and the detrimental effects of haemodialysis can lead to the development of malnutrition. Between 20% and 50% of ...

INTRODUCTION Infective endocarditis (IE) is among the most serious infectious diseases in the western world. Treatment requires lengthy hospitalisation, high-dosage antibiotic therapy and possible valve replacement surgery. Despite advances in treatment, the 1-year mortality remains at 20-40%. Studies indicate that patients experience persisting physical symptoms, diminished quality of life and...

BACKGROUND The study was done to assess the feasibility of conducting a trial evaluating the use of an intradialytic oral nutritional supplement (ONS) on nutritional status. METHODS The study design is a single centre, parallel group, external pilot randomised controlled trial (RCT). The setting was at a haemodialysis unit in Sheffield, UK. The aim was to recruit 30 trial participants to allo...

Most informed consent documents for randomized controlled trials implicitly or explicitly promise the prospective participant that the trial has a reasonable chance of answering a medically important question. The medical literature, however, is replete with descriptions of trials that provided equivocal answers to the questions they addressed. Papers describing the results of such studies may ...

BACKGROUND The Pre-Consultation Educational Group INTERVENTION pilot study seeks to assess the feasibility and inform the optimal design for a definitive randomized controlled trial that aims to improve the quality of decision-making in postmastectomy breast reconstruction patients. METHODS/DESIGN This is a mixed-methods pilot feasibility randomized controlled trial that will follow a single-...

BACKGROUND Pregnant women with depression and/or anxiety prior to pregnancy are at higher risk of preterm birth, breastfeeding problems, postpartum depression, and disruption of the mother-infant attachment. It is well documented that exercise improves psychological well-being in nonpregnant subjects with symptoms of depression. However, in only a few small studies have researchers examined the...