Utilising benefit-risk assessments within clinical trials-a protocol for the BRAINS project.

BACKGROUND: Depending on the treatment to be investigated, a clinical trial could be designed to assess objectives of superiority, equivalence or non-inferiority. The design of the study is affected by many different elements including the control treatment, the primary outcome and associated relationships. In some studies, there could be more than one outcome of interest. In these situations, benefit-risk methodologies could be used to assess the outcomes simultaneously and consider the trade-off between the benefits against the risks of a treatment. Benefit-risk is used within the regulatory industry but seldom included within publicly funded clinical trials within the UK. This project aims to gain an expert consensus on how to select the appropriate trial design (e.g. superiority) and when to consider including benefit-risk methods. METHODS: The project will consist of four work packages: 1. A web-based survey to elicit current experiences and opinions, 2. A rapid literature review to assess any current recommendations, 3. A two-day consensus workshop to gain agreement on the recommendations, and 4. Production of a guidance document. DISCUSSION: The aim of the project is to provide a guideline for clinical researchers, grant funding bodies and reviewers for grant bodies for how to select the most appropriate trial design and when it is appropriate to consider using benefit-risk methods. The focus of the guideline will be on publicly funded trials however, the vision is that the work will be applicable across research settings and we will connect with other organisations and committees as appropriate.

Caring from a distance: the role of telehealth.

BACKGROUND: Telehealth is used to help people manage their heath and maintain independence, but has proved difficult to integrate into routine practice. AIM: To explore the barriers to telehealth and find out what helps to improve its adoption among nursing staff. METHOD: Case studies were compiled from four community health services in the Yorkshire and Humber region that were using telehealth to monitor patients. The case studies used interviews with 84 community nursing, technical and support staff, and 21 managers. Some 40 telehealth users and 12 carers were also interviewed. RESULTS: Factors serving as barriers to the use of telehealth, including lack of planning, insufficient training, lack of time and technological problems. Factors encouraging uptake included giving nurses time to experiment with the technology, a clear service pathway, establishing telehealth champions to troubleshoot and disseminate information, and successful care using telehealth. DISCUSSION: Factors improving the adoption of telehealth in community nursing include: better planning of how the service operates and installing appropriate technology, good communication with nurses and service users, establishing telehealth champions and providing ongoing training and support. CONCLUSION: Many of the barriers in using telehealth can be avoided with better planning and collaboration.