A web based resource to facilitate the conduct of pragmatic RCTs in developing countries Health Services Research Unit University of Aberdeen HSRU is.

A web based resource to facilitate the A web based resource to facilitate the conduct of pragmatic RCTs in developing conduct of pragmatic RCTs in developing

countriescountries

Health Services Research UnitHealth Services Research Unit

University of AberdeenUniversity of Aberdeen

HSRU is funded by the Chief Scientist Office of the Scottish Executive Health Department.

The author accepts full responsibility for this talk.

1 4 9 5

Kirsty McCormack

PRAGMATIC RANDOMISED CONTROLLED TRIALS IN HEALTHCAREPRAGMATIC RANDOMISED CONTROLLED TRIALS IN HEALTHCARE

Other unit staffOther unit staff

•Marion Campbell•Craig Ramsay•Adrian Grant•And all of you!


What is Practihc?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 What is the purpose of the project? (1)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



• To develop the global science of pragmatic RCTs and promote inclusion of their findings as an element in health care decision making



• 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 institutionsPartner institutions


Specific scientific and Specific scientific and technological objectives technological objectives

(1)(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 Specific scientific and technological objectives technological objectives

(2)(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 contributionHSRUs contributionTo 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 strategySearch strategy

• WWW search• Ask known trialists and trial co-

ordinators• Practihc partners

NOTE: Not a comprehensive search


Evaluation criteriaEvaluation 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 templateTrial 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


GuidelinesGuidelines

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

PatientsGood Practice Guidelines


ChecklistsChecklists

• 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’


SoftwareSoftware

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 resourcesInformation 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


ExamplesExamples

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


PRACTiHC websitePRACTiHC 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


Web pageWeb page



Next Next PRACTiHC WorkshopPRACTiHC Workshop

Havana, Cuba9th-12th February 2003

A web based resource to facilitate the conduct of pragmatic RCTs in developing countries Health Services Research Unit University of Aberdeen HSRU is.

Documents

pragmatic trials relevant

design of pragmatic

conduct of trials

clinical trials

protocol slide

conduct of pragmatic

effective slide

healthcare software