How informed is consent in vulnerable populations? Experience using a continuous consent process during the MDP301 vaginal microbicide trial in Mwanza, Tanzania. [PDF]
BACKGROUND: HIV prevention trials conducted among disadvantaged vulnerable at-risk populations in developing countries present unique ethical dilemmas. A key concern in bioethics is the validity of informed consent for trial participation obtained from ...
Soteli, Selephina +44 more
core +1 more source
The Women's international study of long-duration oestrogen after menopause (WISDOM): a randomised controlled trial [PDF]
Background: At the time of feasibility work and final design of the trial there was no randomised control trial evidence for the long-term risks and benefits of hormone replacement therapy.
Knott, C. +31 more
core +1 more source
MObile Technology for Improved Family Planning: update to randomised controlled trial protocol. [PDF]
BACKGROUND: This update outlines changes to the MObile Technology for Improved Family Planning study statistical analysis plan and plans for long-term follow-up.
Free, Caroline +7 more
core +1 more source
Impact of dual antiplatelet therapy after coronary artery bypass surgery on 1-year outcomes in the Arterial Revascularization Trial [PDF]
OBJECTIVES: There is still little evidence to boldport routine dual antiplatelet therapy (DAPT) with P2Y12 antagonists following coronary artery bypass grafting (CABG).
(the ART (Arterial Revascularization Trial) Investigators) +7 more
core +1 more source
A posture and mobility training package for care home staff: results of a cluster randomised controlled feasibility trial (the PATCH trial) [PDF]
Background: provision of care for care home residents with complex needs is challenging. Physiotherapy and activity interventions can improve well-being but are often time-limited and resource intensive.
Hull, K +44 more
core +1 more source
Do baseline characteristics predict response to treatment for low back pain? Secondary analysis of the UK BEAM dataset [ISRCTN32683578] [PDF]
Objectives. To identify characteristics of randomized controlled trial participants which predict greater benefits from physical treatments for low back pain. If successful, this would allow more appropriate selection of patients for different treatments.
Farrin, Amanda +5 more
core +1 more source
BackgroundBreast cancer therapy improved significantly, allowing for different surgical approaches for the same disease stage, therefore offering patients different aesthetic outcomes with similar locoregional control. The purpose of the CINDERELLA trial
Rosa Di Micco (2590996) +23 more
core +1 more source
Modelling the rate of change in a longitudinal study with missing data, adjusting for contact attempts [PDF]
The Collaborative Ankle Support Trial (CAST) is a longitudinal trial in which interest lies in the rate of improvement, the effectiveness of reminders and potentially informative missingness.
Mouna Akacha +3 more
core +1 more source
Recruitment to randomised trials : Strategies for Trial Enrolment and Participation Study. The STEPS study [PDF]
Objectives: To identify factors associated with good and poor recruitment to multicentre trials. Data sources: Part A: database of trials started in or after 1994 and were due to end before 2003 held by the Medical Research Council and Health Technology
Snowdon, Claire +35 more
core +1 more source
Aims This study sought to provide estimates for the different rates of deep surgical site infection as measured by the Centres for Disease Control definition after hip fracture surgery between patients treated with either incisional Negative Pressure ...
Cook, J +3 more
core +1 more source

