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Kirsty McCormack

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

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Kirsty McCormack

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  1. Kirsty McCormack

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

  3. What is Practihc? • Pragmatic Randomised Trials in Health Care Systems • Funded by theEuropean 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

  4. 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

  5. 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

  6. 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.

  7. Partner institutions

  8. 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

  9. 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

  10. 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

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

  12. 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.

  13. 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

  14. 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

  15. 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’

  16. 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

  17. 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

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

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

  20. Web page

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

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