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Overall survival and indices of disease progression will be measured as the secondary outcomes.
Ethical approval has been obtained from the ethics committee of Peking University Third Hospital (M2019388). Informed written consent will be obtained from each participant. Dissemination of the study protocol and data will take place primarily through a specially designed online data system (http//www.chalsr.net/). The collective results of the study will be published in peer-reviewed journals and shared in scientific presentations.
NCT04328675.
NCT04328675.
Breast cancer-related lymphoedema (BCRL) is a common phenomenon. When lymphoedema is diagnosed late, options for treatment are diminished. Therefore, early diagnosis and treatment are very important to alter the potential deleterious evolution. Lymphofluoroscopy visualises the superficial lymphatic architecture in detail, giving the opportunity to detect a disturbance in the lymphatic transport (ie, dermal backflow) before the lymphoedema is clinically visible.The main objective is to investigate if there is an additional effect of a compression garment on top of the usual care (ie, information and exercises) in patients with early disturbance of the lymphatic transport after breast cancer treatment. Development of clinical lymphoedema and/or deterioration of the dermal backflow visualised by lymphofluoroscopy is investigated.
All patients scheduled for breast cancer surgery with unilateral axillary lymph node dissection or sentinel node biopsy in the Multidisciplinary Breast Clinic of the University Hosptocol has been approved by the Ethical Committee of the University Hospitals Leuven. Results will be disseminated by peer-reviewed scientific journals and presentation at international congresses.
NCT03210311 CONCLUSION The investigators hypothesise that development of clinical BCRL can be prevented and/or the dermal backflow can be stabilised or improved, if a preventive treatment with compression garment is started in the early phase of disturbance.
NCT03210311 CONCLUSION The investigators hypothesise that development of clinical BCRL can be prevented and/or the dermal backflow can be stabilised or improved, if a preventive treatment with compression garment is started in the early phase of disturbance.
Performing randomised controlled trials (RCTs) in neonatal intensive care is challenging in many ways. While restrictive inclusion criteria or busy study protocols are obvious barriers, external barriers leading to termination of a study are seldom discussed. selleck chemicals The aim of this study was to describe barriers for inclusion of families in neonatal intensive care in an RCT aiming to evaluate the effects of continuous skin-to-skin contact on mood and sleep quality in parents of preterm infants, as well as the quality of parent-infant interaction and salivary cortisol concentrations at the time of discharge.
A descriptive study.
Three out of seven tertiary neonatal intensive care units in Sweden participated in a two-arm RCT that was terminated because of low inclusion rate.
Before termination of the study, 11 out of 242 families assessed for eligibility were included for participation.
The major barriers for inclusion in this RCT were external due to (1) lack of intensive care beds in the neonatal ward, causing medically stable infants to be transferred back to the referring hospital quicker than expected, (2) moving directly from the delivery room to a family room without passing an open bay intensive care room or (3) transferring from one neonatal ward to another with the same care level to increase availability of intensive care beds where needed. Other barriers were the inclusion criteria ‘single-birth’ and ‘Swedish-speaking parent’.
The major barriers for including participants were external constituted by transferals between neonatal wards and cities due to lack of intensive care beds. This is a multifactorial issue related to organisational structures. However, since this affects the possibilities to perform research this study highlights some suggestions to consider when planning prospective intervention studies within a neonatal setting.
NCT03004677.
NCT03004677.
Despite evidence that cardiac rehabilitation (CR) is an essential component of care for people with heart failure, uptake is low. A centre-based format is a known barrier, suggesting that home-based programmes might improve accessibility. The aim of SCOT Rehabilitation EnAblement in CHronic Heart Failure (REACH-HF) is to assess the implementation of the REACH-HF home-based CR intervention in the context of the National Health Service (NHS) in Scotland.This paper presents the design and protocol for this observational implementation study. Specific objectives of SCOTREACH-HF are to (1) assess service-level facilitators and barriers to the implementation of REACH-HF; (2) compare real-world patient and caregiver outcomes to those seen in a prior clinical trial; and (3) estimate the economic (health and social) impact of implementing REACH-HF in Scotland.
The REACH-HF intervention will be delivered in partnership with four ‘Beacon sites’ across six NHS Scotland Health Boards, covering rural and urban areas. Hthe University of Glasgow’s Research Governance Framework. Findings will be reported to the funder and shared with Beacon Sites, to facilitate service evaluation, planning and good practice. To broaden interest in, and understanding of REACH-HF, we will seek to publish in peer-reviewed scientific journals and present at stakeholder events, national and international conferences.
The global opioid-related disease burden is significant. Opioid agonist treatment (OAT) can be effective in reducing illicit opioid use and fatal overdose, and improving multiple health and social outcomes. Despite evidence for its effectiveness, there are significant deficits in OAT globally. COVID-19 has required rapid adaptation of remote models of healthcare. Telemedicine is not used routinely in OAT, and little is known about the current levels of use and effectiveness. The objective of this review is to describe models of telemedicine and their efficacy.
This scoping review uses the review methodology described by Arksey and O’Malley and adapted by Levac
. The search strategy developed by the medical librarian at the Irish College of General Practitioners in conjunction with the research team will involve five databases (PubMed, EMBASE, the Cochrane Library, PsycInfo and OpenGrey) and the hand searching of reference lists. A limited initial search of two databases will be completed to refine search terms, followed by a second comprehensive search using newly refined search terms of all databases and finally hand searching references of included studies.