Search results for "Study Design"
showing 10 items of 51 documents
Peer Support for People Living With HIV: A Scoping Review
2021
Peer support for people living with HIV has gained increasing traction and is considered a way to take an active role in self-management. The existing research examining peer support interventions has reported promising evidence of the benefits of peer support. The purpose of our scoping review was to describe research on peer support for people living with HIV. We included 53 studies and sorted them into analytic categories and conducted descriptive analyses. The studies that were published between November/December 2000 and May 2021, had a range of study designs and heterogeneous priority groups, and included 20,657 participants from 16 countries. We identified 43 evaluations of the effe…
Study design of Heart failure Events reduction with Remote Monitoring and eHealth Support (HERMeS)
2020
Aims: The role of non‐invasive telemedicine (TM) combining telemonitoring and teleintervention by videoconference (VC) in patients recently admitted due to heart failure (HF) (‘vulnerable phase’ HF patients) is not well established. The aim of the Heart failure Events reduction with Remote Monitoring and eHealth Support (HERMeS) trial is to assess the impact on clinical outcomes of implementing a TM service based on mobile health (mHealth), which includes remote daily monitoring of biometric data and symptom reporting (telemonitoring) combined with VC structured, nurse‐based follow‐up (teleintervention). The results will be compared with those of the comprehensive HF usual care (UC) strateg…
The German COPD cohort COSYCONET: Aims, methods and descriptive analysis of the study population at baseline
2016
Abstract Background The German COPD cohort study COSYCONET (" CO PD and SY stemic consequences- CO morbidities NET work") investigates the interaction of lung disease, comorbidities and systemic inflammation. Recruitment took place from 2010 to 2013 in 31 study centers. In addition to the baseline visit, follow-up visits are scheduled at 6, 18, 36 and 54 months after baseline. The study also comprises a biobank, image bank, and includes health economic data. Here we describe the study design of COSYCONET and present baseline data of our COPD cohort. Methods Inclusion criteria were broad in order to cover a wide range of patterns of the disease. In each visit, patients undergo a large panel …
Bayesian subcohort selection for longitudinal covariate measurements in follow‐up studies
2022
We propose an approach for the planning of longitudinal covariate measurements in follow-up studies where covariates are time-varying. We assume that the entire cohort cannot be selected for longitudinal measurements due to financial limitations, and study how a subset of the cohort should be selected optimally, in order to obtain precise estimates of covariate effects in a survival model. In our approach, the study will be designed sequentially utilizing the data collected in previous measurements of the individuals as prior information. We propose using a Bayesian optimality criterion in the subcohort selections, which is compared with simple random sampling using simulated and real follo…
Systematic handling of missing data in complex study designs : experiences from the Health 2000 and 2011 Surveys
2016
We present a systematic approach to the practical and comprehensive handling of missing data motivated by our experiences of analyzing longitudinal survey data. We consider the Health 2000 and 2011 Surveys (BRIF8901) where increased non-response and non-participation from 2000 to 2011 was a major issue. The model assumptions involved in the complex sampling design, repeated measurements design, non-participation mechanisms and associations are presented graphically using methodology previously defined as a causal model with design, i.e. a functional causal model extended with the study design. This tool forces the statistician to make the study design and the missing-data mechanism explicit…
Intervention studies to foster resilience – A systematic review and proposal for a resilience framework in future intervention studies
2017
Psychological resilience refers to the phenomenon that many people are able to adapt to the challenges of life and maintain mental health despite exposure to adversity. This has stimulated research on training programs to foster psychological resilience. We evaluated concepts, methods and designs of 43 randomized controlled trials published between 1979 and 2014 which assessed the efficacy of such training programs and propose standards for future intervention research based on recent developments in the field. We found that concepts, methods and designs in current resilience intervention studies are of limited use to properly assess efficacy of interventions to foster resilience. Major pro…
Rationale and Design of the Efficacy of a Standardized Diuretic Protocol in Acute Heart Failure Study
2021
AIMS: Although acute heart failure (AHF) with volume overload is treated with loop diuretics, their dosing and type of administration are mainly based upon expert opinion. A recent position paper from the Heart Failure Association (HFA) proposed a step-wise pharmacologic diuretic strategy to increase the diuretic response and to achieve rapid decongestion. However, no study has evaluated this protocol prospectively. METHODS AND RESULTS: The Efficacy of a Standardized Diuretic Protocol in Acute Heart Failure (ENACT-HF) study is an international, multicentre, non-randomized, open-label, pragmatic study in AHF patients on chronic loop diuretic therapy, admitted to the hospital for intravenous …
Particulate Matter Exposure and Attention-Deficit/Hyperactivity Disorder in Children: A Systematic Review of Epidemiological Studies
2019
Attention-deficit/hyperactivity disorder (ADHD) is the most common cognitive and behavioural disorder affecting children, with a worldwide-pooled prevalence of around 5%. Exposure to particulate matter (PM) air pollution is suspected to be associated with autism spectrum disorders and recent studies have investigated the relationship between PM exposure and ADHD. In the absence of any synthesis of the relevant literature on this topic, this systematic review of epidemiological studies aimed to investigate the relationship between the exposure of children to PM and ADHD and identify gaps in our current knowledge. In December 2018, we searched the PubMed and EMBASE databases. We only included…
Comparing the use of patient-reported outcomes in clinical studies in Europe in 2008 and 2018: a literature review
2021
Abstract Purpose Several guidelines for the use of patient-reported outcomes (PROs) in clinical studies have been published in the past decade. This review primarily aimed to compare the number and compliance with selected PRO-specific criteria for reporting of clinical studies in Europe using PROs published in 2008 and 2018. Secondarily, to describe the study designs, PRO instruments used, patient groups studied, and countries where the clinical studies were conducted. Methods A literature search was conducted in MEDLINE to identify eligible publications. To assess the number of publications, all abstracts were screened for eligibility by pairs of reviewers. Compliance with PRO-specific cr…
Diuretic Strategies in Acute Heart Failure and Renal Dysfunction: Conventional vs Carbohydrate Antigen 125-guided Strategy. Clinical Trial Design
2017
Abstract Introduction and objectives The optimal treatment of patients with acute heart failure (AHF) and cardiorenal syndrome type 1 (CRS-1) is far from being well-defined. Arterial hypoperfusion in concert with venous congestion plays a crucial role in the pathophysiology of CRS-I. Plasma carbohydrate antigen 125 (CA125) has emerged as a surrogate of fluid overload in AHF. The aim of this study was to evaluate the clinical usefulness of CA125 for tailoring the intensity of diuretic therapy in patients with CRS-1. Methods Multicenter, open-label, parallel clinical trial, in which patients with AHF and serum creatinine ≥ 1.4 mg/dL on admission will be randomized to: a) standard diuretic str…