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 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

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Guidelines and checklists should be evidence based and not superceded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 www.practihc.org
The collaboration will make all tools and resources accessible to people planning evaluations of health care interventions via the PRACTiHC website

20. Web page

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