Dataset Information

European active surveillance study of women taking HRT (EURAS-HRT): study protocol [NCT00214903].

ABSTRACT: The post marketing safety surveillance program for a drug containing a new chemical entity should assess both, the safety outcomes that relate specifically to the targeted population, as well as those that could potentially be related to special pharmacological characteristics of the drug. Active safety surveillance using valid epidemiological study designs has been proven to be a pertinent and reliable method to approach this endeavor.The primary objective of the study is to compare incidence rates of serious adverse events in users of all types of newly prescribed oral HRT products. This active surveillance study will assess pertinent cardiovascular outcomes--in particular venous and arterial thromboembolism--and other serious adverse events (SAEs) in new HRT users over a period of several years. One product under surveillance is Angeliq, which contains the novel progestagen drospirenone (DRSP) combined with estradiol. In addition, all other oral combined HRT products with a novel progestagen or estrogen that will be newly marketed during the study period will be studied. These new HRT products will be compared with established HRT products. The combined cohort will include at least 30,000 women recruited in several European countries. At least 90,000 years of observation are expected from the field work which started in early 2002 and will end around 2008. The participating women will complete a baseline survey using a self-administered questionnaire to describe the baseline risk. After 6 months, 12 months, and then on an annual basis, they will fill out a questionnaire in which they record complaints and events during the use of the prescribed HRTs. All adverse outcomes occurring during the observational period will be evaluated.A complete lifetime medical history, individually validated SAEs over time, and a low loss to follow-up rate are essential for a robust safety assessment. Therefore, the lifetime history of diseases and relevant medications will be documented. Reported SAEs will be validated and analyzed. A four level, multi-faceted follow-up process was established to ensure low loss to follow-up rates (e.g., 3-5% after three years of follow up). Multivariate methods will be used to adjust for confounding.

SUBMITTER: Dinger JC

PROVIDER: S-EPMC1351171 | biostudies-literature | 2006 Jan

REPOSITORIES: biostudies-literature

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European active surveillance study of women taking HRT (EURAS-HRT): study protocol [NCT00214903].

Dinger Juergen C JC Heinemann Lothar A J LA

BMC women's health 20060117

<h4>Background</h4>The post marketing safety surveillance program for a drug containing a new chemical entity should assess both, the safety outcomes that relate specifically to the targeted population, as well as those that could potentially be related to special pharmacological characteristics of the drug. Active safety surveillance using valid epidemiological study designs has been proven to be a pertinent and reliable method to approach this endeavor.<h4>Methods/design</h4>The primary object ...[more]

PMID: 16417621

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Project description:IntroductionOne in five men is likely to receive a diagnosis of prostate cancer (PCa) by the age of 85 years. Men diagnosed with low-risk PCa may be eligible for active surveillance (AS) to monitor their cancer to ensure that any changes are discovered and responded to in a timely way. Communication of risk in this context is more complicated than determining a numerical probability of risk, as patients wish to understand the implications of risk on their lives in concrete terms. Our study will examine how risk for PCa is perceived, experienced and communicated by patients using AS with their health professionals, and the implications for treatment and care.Methods and analysisThis is a proof of concept study, testing out a multimethod, qualitative approach to data collection in the context of PCa for the first time in Australia. It is being conducted from November 2016 to December 2017 in an Australian university hospital urology clinic. Participants are 10 men with a diagnosis of localised PCa, who are using an AS protocol, and 5 health professionals who work with this patient group (eg, urologists and Pca nurses). Data will be collected using observations of patient consultations with health professionals, patient questionnaires and interviews, and interviews with healthcare professionals. Analysis will be conducted in two stages. First, observational data from consultations will be analysed thematically to encapsulate various dimensions of risk classification and consultation dialogue. Second, interview data will be coded to derive meaning in text and analysed thematically. Overarching themes will represent patient and health professional perspectives of risk communication.Ethics and disseminationEthical approval for the study has been granted by Macquarie University Human Research Ethics Committee, approval 5201600638. Knowledge translation will be achieved through publications, reports and conference presentations to patients, families, clinicians and researchers.

Project description:INTRODUCTION:The epidemiology, pathogenesis, management and outcomes of cerebral palsy (CP) in low-income and middle-income countries including Vietnam are unknown because of the lack of mechanisms for standardised collection of data. In this paper, we outline the protocol for developing a hospital-based surveillance system modelled on the Paediatric Active Enhanced Disease Surveillance (PAEDS) system in Australia. Using PAEDS-Vietnam we will define the aetiology, motor function and its severity, associated impairments, and nutritional and rehabilitation status of children with CP in Hanoi, Vietnam. These essential baseline data will inform future health service planning, health professional education and training, and family support. METHODS AND ANALYSIS:This is a hospital-based prospective surveillance of children with CP presenting to the rehabilitation, neurology and general paediatric services at the National Children's Hospital and St Paul Hospital in Hanoi. We will use active, prospective daily case-finding for all children with CP aged <18 years who are hospitalised or present to outpatient departments. Following parental consent, data will be collected using a modified version of the Australian Cerebral Palsy Register questionnaire. The data collection form has been developed in consultation with local and international experts and translated into Vietnamese. Information collected will include demographics, maternal health and birth history, type and severity of CP, known risk factors for CP, and nutrition, immunisation, education and rehabilitation status. ETHICS AND DISSEMINATION:This study was approved by the Hanoi Medical University Institutional Review Board (decision no 1722) and The University of Sydney Human Research Ethics Committee (approval no 2016/456). Establishment of PAEDS-Vietnam will enable hospital-based surveillance of CP for the first time in Vietnam. It will identify preventable causes of CP, patient needs and service gaps, and facilitate early diagnosis and intervention. Study findings will be disseminated through local and international conferences and peer-reviewed publications.

Project description:BACKGROUND:Sub-Saharan Africa (SSA) has the highest number of people living with HIV/AIDS, with Nigeria, South Africa, and Uganda accounting for 48% of new infections. A systematic review of the HIV burden among women engaged in sex work (WESW) in 50 low- and middle-income countries found that they had increased odds of HIV infection relative to the general female population. Social structural factors, such as the sex work environment, violence, stigma, cultural issues, and criminalization of sex work are critical in shaping sexually transmitted infection (STI)/HIV risks among WESW and their clients in Uganda. Poverty is the most commonly cited reason for involvement in sex work in SSA. Against this backdrop, this study protocol describes a randomized controlled trial (RCT) that tests the impact of adding economic empowerment to traditional HIV risk reduction (HIVRR) to reduce new incidence of STIs and HIV among WESW in Rakai and the greater Masaka regions in Uganda. METHODS:This three-arm RCT will evaluate the efficacy of adding savings, financial literacy and vocational training/mentorship to traditional HIVRR on reducing new incidence of STI infections among 990 WESW across 33 hotspots. The three arms (n?=?330 each) are: 1) Control group: only HIVRR versus 2) Treatment group 1: HIVRR plus Savings plus Financial Literacy (HIVRR + S?+?FL); and 3) Treatment group 2: HIVRR plus S plus FL plus Vocational Skills Training and Mentorship (V) (HIVRR + S?+?FL?+?V). Data will be collected at baseline (pre-test), 6, 12, 18 and 24-months post-intervention initiation. This study will use an embedded experimental mixed methods design where qualitative data will be collected post-intervention across all conditions to explore participant experiences. DISCUSSION:When WESW have access to more capital and/or alternative forms of employment and start earning formal income outside of sex work, they may be better able to improve their skills and employability for professional advancement, thereby reducing their STI/HIV risk. The study findings may advance our understanding of how best to implement gender-specific HIV prevention globally, engaging women across the HIV treatment cascade. Further, results will provide evidence for the intervention's efficacy to reduce STIs and inform implementation sustainability, including costs and cost-effectiveness. TRIAL REGISTRATION:ClinicalTrials.gov , ID: NCT03583541 .

Dataset Information

European active surveillance study of women taking HRT (EURAS-HRT): study protocol [NCT00214903].

Publications

European active surveillance study of women taking HRT (EURAS-HRT): study protocol [NCT00214903].

Similar Datasets

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