AIM The study compared the duration of maintenance of treatment in patients with type 2 diabetes (T2D) using dual therapy with either metformin and sitagliptin (M-Sita) or metformin and a sulphonylurea (M-SU). MATERIALS AND METHODS This observational study included adult patients with T2D who had responded inadequately to metformin monotherapy and therefore had started de-novo treatment with ...

The Women's Health Initiative randomized controlled trial found a trend (p = 0.09) toward a lower breast cancer risk among women assigned to daily 0.625-mg conjugated equine estrogens (CEEs) compared with placebo, in contrast to an observational literature that mostly reports a moderate increase in risk with estrogen-alone preparations. In 1993-2004 at 40 US clinical centers, breast cancer haza...

Establishing, defining, collecting, and classifying outcomes are critical activities in clinical research. The Women’s Health Initiative (WHI) has both observational study (OS) and clinical trial (CT) components designed to examine simultaneously the impact of a number of factors on many of the major causes of morbidity and mortality in postmenopausal women. Thus, WHI outcomes cover a wide rang...

BACKGROUND CHRONOS was a large naturalistic study designed to evaluate the effectiveness and safety of agomelatine in the management of patients with major depression in routine clinical practice. METHODS Patients (n=6,276) with a moderate or severe major depressive episode without psychotic symptoms were treated initially as outpatients (80.2%) or in psychiatric facilities (19.8%) in 54 regi...

STUDY OBJECTIVES To determine whether the duration of sleep, sleep quality, insomnia, or sleep disturbance was associated with incident breast cancer in the Women's Health Initiative (WHI). DESIGN Prospective cohort study. SETTING Women enrolled in one of the Clinical Trial (CT) arms or the Observational Study (OS) from the WHI conducted in the United States. PARTICIPANTS This study inclu...

OBJECTIVE To quantify reporting errors, measure incidence of postpartum haemorrhage (PPH) and define risk factors for PPH (≥500 ml) and progression to severe PPH (≥1500 ml). DESIGN Prospective observational study. SETTING Two UK maternity services. POPULATION Women giving birth between 1 August 2008 and 31 July 2009 (n = 10 213). METHODS Weighted sampling with sequential adjustment by m...

OBJECTIVE A number of randomised controlled trials (RCT) have compared control groups with TLC-NOSF dressings (UrgoStart) on chronic wounds. Our aim was to determine whether the clinical trials' results translate into routine management of such wounds, by pooling the data from real-life observational studies. METHOD Observational studies, conducted in France and Germany, evaluating current pr...

Influenza vaccination is estimated to only be effective in 17-53% of older adults. Multiple patient behaviors and psychological factors have been shown to act as 'immune modulators' sufficient to influence vaccination outcomes. However, the relative importance of such factors is unknown as they have typically been examined in isolation. The objective of the present study was to explore the effe...

BACKGROUND Benchmarking Controlled Trial (BCT) is a concept which covers all observational studies aiming to assess impact of interventions or health care system features to patients and populations. AIMS To create and pilot test a checklist for appraising methodological validity of a BCT. METHODS The checklist was created by extracting the most essential elements from the comprehensive set...

BACKGROUND The effects of dietary protein on bone health are controversial. OBJECTIVE We examined the relation between protein intake with fracture and bone mineral density (BMD) within the Women's Health Initiative (WHI). DESIGN This prospective analysis included 144,580 women aged 50-79 y at baseline in the WHI clinical trials (CTs) and observational study (OS) that recruited participants...