Kirsty McCormack

Other unit staff Marion Campbell Craig Ramsay Adrian Grant And all of you!

What is Practihc? Pragmatic Randomised Trials in Health Care Systems Funded by the European Commission's 5th Framework Programme for international collaboration with Developing Countries An international research and technology development (RTD) network to facilitate information for action on priority health problems

What is the purpose of the project? (1) To improve partner countries health systems by increasing their capacity to evaluate health care delivery systems, specific health policy, public health and clinical choices and identify those options which are effective

What is the purpose of the project? (2) To develop the global science of pragmatic RCTs and promote inclusion of their findings as an element in health care decision making

What is the purpose of the project? (3) To promote RTD co-operation internationally by consolidating a network of established centres with expertise in RCTs, and to extend this network to support the achievement of scientific excellence and real world health system decision making relevance in neighbouring countries.

Partner institutions

Specific scientific and technological objectives (1) To locate or develop tools and resources to support development and use of pragmatic RCTs To study up to 100 partner experiences in pragmatic RCTs To systematically review the published literature on conduct of RCTs in developing countries

Specific scientific and technological objectives (2) To develop and pilot a programme of workshops on the design and conduct of trials To promote the science of pragmatic randomised trials To reinforce scientific and technological co-operation between researchers in developing countries and in the European Community

HSRUs contribution To locate or develop research tools and resources to aid the design of pragmatic trials e.g. Trial protocol template Guidelines Checklists Software Information resources Examples

Search strategy WWW search Ask known trialists and trial co-ordinators Practihc partners NOTE: Not a comprehensive search

Evaluation criteria Relevant to pragmatic trials Relevant to developing countries Guidelines and checklists should be evidence based and not superceded Software should be free, user friendly, can be downloaded, can be packaged, and works.

Trial protocol template A trial protocol template has been developed using a variety of resources including: A web search for existing protocol templates Review of existing trial protocols Consultation with trial-co-ordinators

Guidelines Declaration of Helsinki ICH GCP EU Data Protection Act Consort Statement Guidelines for clinical trials in South Africa Developing Written Information for Patients Good Practice Guidelines

Checklists Initial search concludes that many checklists located are too specific and not relevant Will need to develop checklists for the purposes of practihc Checklists for each section of the protocol template have been developed within the context of ‘things to consider when writing a protocol’

Software Software located: Randomisation programs Sample size calculator (HSRU) Data management and analysis tool (EpiInfo) Software to be commissioned: Budgeting tool Project management tools e.g. Gantt chart and monitoring tool

Information resources Resource Centre for Randomised Trials (RCRT) TrialsCentral MRC Trials Managers’ Network The Cochrane library Directory of randomisation software and services UK Clearing House on Health Outcomes

Examples Participants information leaflets Informed consent forms Recruitment strategies Participant retention strategies Dummy tables Sample size justifications Progress and final reports

PRACTiHC website www.practihc.org The collaboration will make all tools and resources accessible to people planning evaluations of health care interventions via the PRACTiHC website www.practihc.org

Web page

Next PRACTiHC Workshop Havana, Cuba 9th-12th February 2003