Research for Better Health Outcomes

1. Research for Better Health Outcomes John Baker Clinical Director

2. Research for Better Health Outcomes How do I design a Research project? Give me some examples? What else do I need to think about?

3. 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

4. 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

5. 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

6. Schedule of activities

7. Down to details… Develop hypothesis Study design Develop protocol Registration, Ethics, Maori/Pacific & Research Committee Data management & data analysis Consult biostatistician Consult biostatistician Consult biostatistician Consult Research Officer Consult biostatistician Resources

8. Research for Better Health Outcomes How do I design a Research project? Give me some examples? What else do I need to think about?

9. Example 1 Q: Is participating in Randomised Controlled Trials beneficial to the individual in the short-term?

10. 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. Example 1

11. 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). Example 1

12. Outcomes: Primary: All-cause mortality 2003 to 2007 (from Casemix & NIHS). Secondary: All-cause hospitalisation & CV mortality 2003 to 2007 (from NHIS). Example 1

13. Example 1

14. Example 2 Q: What is the clinical information value of the EDS?

15. Alderton, M., Callen, J. Are general practitioners satisfied with electronic discharge summaries? Health Information Management Journal. 2007;36:7-12 Example 2

16. Subjects: 26 patients with T2DM, 8 GPs, and 4 DNS consented. Method: Qualitative research study:- patients had a semi-structured telephone interview; GPs were interviewed by telephone; and DNS had a face-to-face interview. Interviews were transcribed and analysed using a general inductive approach (NVivo Qualitative analysis software). Example 2

17. Outcomes: The EDS is an effective tool to communicate with GPs and diabetes nurses. Improvements could be made to make it more useful to patients attending Middlemore hospital. Health literacy is low for these patient groups…more emphasis should be given to clearer, oral communication, particularly about treatment changes, prior to their discharge from hospital. Example 2

18. Example 2

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

20. Feasibility Regulatory approval Ethics approval Maori consultation Institutional approval Good Clinical Practice (GCP) Guidelines What else do I need to think about?

21. Feasibility Do I have adequate funding? Do I have time to complete the study? Am I sure that I can complete recruitment on time & within budget?

22. Regulatory approval - ethics Full ethics versus expedited approval. Full ethics applications require “locality” & Maori consultation. Ethics approval must be obtained before the study commences!!!

23. Regulatory approval - ethics Forms (http://www.ethicscommittees.health.govt.nz/) Full Ethics Review Full Ethics Review Application Form Completion Guidelines for Full Ethics Review Application Approximately 8 weeks from submission deadline Expedited Ethics Review Expedited Ethics Review Application Form. Completion and Process Guidelines for Expedited Ethics Review Application Approximately 3 weeks from submission. Participant Information Sheet and Consent Form When writing information sheets and consent forms for both Full & Expedited Applications, please follow the guidelines, from page 21-28 of the Completion Guidelines for Full Ethics Review.

24. Regulatory approval - institutional Processes vary between institutions. May require project registration & sign-off by clinical head & service manager. Usually requires study protocol, budget, & evidence of ethics approval Institutional approval must be obtained before the study commences.

25. Maori consultation Maori Consultation is required under the NZ National Ethic’s Committee process for all health research conducted in New Zealand Outline the context and the relevance of the research to Maori (e.g. data about incidence of research issue for Maori). This helps to determine the scope of the consultation required.

26. Example A new drug for treating diabetic nephropathy How common is diabetic nephropathy in Maori? What is known about outcomes for Maori who have diabetic nephropathy (i.e. are there disparities)? Is there any DHB specific data? But also is this drug specific to diabetes or might it be useful for other forms of kidney disease?

27. Section F of the NAF-2009v1 How many Maori do you expect to be recruiting? What do you know about the ethnicity mix of population from which you are recruiting participants (e.g. 32% of CKD4 patients at CMDHB are Maori)? If you were the researcher, explain how you would ensure that at least 30% of study participants were Maori? You must provide evidence of consultation

28. Maori consultation Collecting ethnicity – NZ Health and Disability Sector standards (MoH website) What might ‘being Maori’ mean in relation to this study? Engaging whaanau Wairua, whaanau and mental health Te Reo Maaori

29. GCP - Historical Perspective Nuremberg Code (1948) Kefauver-Harris Amendment (1962) Declaration of Helsinki (1964) International Conference on Harmonization (ICH) – (1990’s)

30. ICH definition - GCP "A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected" ICH E6 1.24

31. GCP - Informed Consent A process by which a subject voluntarilyconfirms his/her willingness to participate in a trial having been informed of all aspects of the trial Informed consent is documented by means of a written, signed and dated informed consent form

32. Thank you