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Research for Better Health Outcomes

Research for Better Health Outcomes. John Baker. Research for Better Health Outcomes. Why do we need Research? How do I design a Research project? Give me an example? What else do I need to think about?. Background. CMDHB’s long history of innovation Plastics and Orthopaedics

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Research for Better Health Outcomes

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  1. Research for Better Health Outcomes John Baker

  2. Research for Better Health Outcomes • Why do we need Research? • How do I design a Research project? • Give me an example? • What else do I need to think about?

  3. Background CMDHB’s long history of innovation Plastics and Orthopaedics Information Services Integrated Care & Community initiatives Annual Science Meeting (Science Fest) 1998 Innovation Fund with $2,000 grants in 2000 CCRep (independent clinical trial unit) 2001 First DHB with a Research Strategy 2009

  4. CCRep Clinical Trial Activity

  5. “Good for patients” who participate Provides access to drugs not routinely available Keeps clinicians up to date with new developments Helps DHB budgets Doesn’t provide outcomes we seek Limited by lack of workforce development Regulatory approval process difficult & time-consuming Community consultation & participation limited Strengths/Weaknesses(of what we do now) We need more investigator-initiated research…

  6. Research for Better Health Outcomes • Why do we need Research? • How do I design a Research project? • Give me an example? • What else do I need to think about?

  7. How to plan a research project? Perform a Literature search A good idea... Hypothesis Write Research Protocol Find the money…. Biostatistics review – power calculation Develop a budget

  8. Research study design • Cohort study • Case-control study • Cross-sectional study • Community survey • Qualitative research • Randomised controlled clinical trial • Double-blind, single blind, open label Observational research

  9. Protocol development • Hypothesis & rationale • Literature review • Primary outcome variable • Secondary outcome variables • Study population (inclusion/exclusion criteria) • Study design • Number needed to study (power calculation) • Duration of study (DV time-dependent) • Schedule of activities (i.e. visits, tests, etc)

  10. Protocol development Hypothesis & rationale Literature review Primary outcome variable Secondary outcome variables Study population (inclusion/exclusion criteria) Study design Number needed to study (power calculation) Duration of study (DV time-dependent) Schedule of activities (i.e. visits, tests, etc) Qualitative Research

  11. Schedule of activities

  12. Develop hypothesis Study design Develop protocol Registration, Ethics, Maori/Pacific & Research Committee Data management & data analysis Consult biostatistician Consult biostatistician Consult biostatistician Consult CMDHB Research Officer Consult biostatistician Down to details… Resources CCRep Stats clinic 2-weekly

  13. Research for Better Health Outcomes • Why do we need Research? • How do I design a Research project? • Give me an example? • What else do I need to think about?

  14. Example... Q: Is participating in Randomised Controlled Trials beneficial to the individual in the short-term?

  15. Example... Braunholtz DA, Edwards SJL, Lilford LJ. Are randomized clinical trials good for us (in the short term)? Evidence for a “trial effect”. J Clin Epidemiol 2001;54:217-24.

  16. Example... • Subjects: 252 participants in the ADVANCE and ONTARGET trials recruited July 2001 to December 2003 and followed up until December 2007. • Control group: 504 age, gender, and ethnicity-matched subjects who meet the entry criteria for ONTARGET & ADVANCE selected from outpatients who attended Middlemore hospital between 2001 & 2003 (from Casemix).

  17. Example... Outcomes: • Primary: All-cause mortality 2003 to 2007 (from Casemix & NIHS). • Secondary: All-cause hospitalisation & CV mortality 2003 to 2007 (from NHIS).

  18. Example...

  19. Research for Better Health Outcomes • Why do we need Research? • How do I design a Research project? • Give me an example? • What else do I need to think about?

  20. Is the project feasible? • Observational research so expedited EC review applies? • Participants de-identified for data analysis so consent not required? • Do I have the time to complete the study? • How can I fund the study?

  21. Thank you

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