introduction to clinical research an interactive session · introduction to clinical research an...
Post on 11-Apr-2018
213 Views
Preview:
TRANSCRIPT
Introduction to Clinical research An interactive session
Prof Edward Janus
Director of Research Western Health
What area in the Hospital or University do you work in?
• What occupational group do you belong to?
• Have you done any research before?
• What sorts of questions do you want to address?
• Who do you know that you could work with?
• Who can mentor you?
• Learn by doing – enjoy the fun of discovery
• Make a difference
Research/Quality
• Research
– Generation of new knowledge
• Quality assurance
– Best practice - applying knowledge e.g from research
– Research translation/implementation science
– (vs. organisational risk, safety, standards, accreditation)
4
What is best practice?
Literature/systematic review
UNKNOWN KNOWN
Are we doing it? (Audit)
YES NO
What do we think is best practice?
SAFE? FEASIBLE?
DOES IT WORK? Pilot RCT
Other designs
QUALITY IMPROVEMENT
Research • Question
• Current knowledge- evidence
• Refine question
• Develop research protocol & refine it
• Hypothesis
• Aims
• Methods
• Carrying out the project – resources
• Ethics approval
Research outcomes
• Results
• Analysis
• Conclusions & implications
• Presentation
• Publication
• Dissemination & implementation in practice
• Evaluation – New research questions
Questions
• Are our myocardial infarction patients getting appropriate secondary prevention?
• Can we prevent falls?
• How much does osteomyelitis cost Western Health – How much does it cost Australia?
• Can we prevent diabetes?
• Any other Questions you can suggest?
Current Knowledge - Evidence
• Literature reviews, guidelines etc
• What is known?
• Are we doing it?
• How well?
• Can we do it better?
• What don’t we know?
• What do we want to find out?
• Could we do that here?
• What else?
Refining the questions
• What is the best available treatment for secondary prevention after myocardial infarction?
• What proportion of our patients get this?
in cardiology settings?
in general medical wards?
• Are they different – if so why?
• What else?
Refining the questions
• Can we prevent diabetes?
• Yes in expensive one on one interventions in randomised controlled trials using diet and lifestyle
• Would it work in groups of at risk subjects in an Australian setting
• How well would it work?
• Would it be cost effective?
• What else?
Develop and refine the research protocol
• Get your hypotheses and aims very clear
• Get help from experienced colleagues
• It’s an iterative process
• It helps you work out what you need to do in your project
• Subjects – numbers- expected effect size – power and statistics
• Intervention- duration- staff-costs- funds- analysis- what do you expect to find – do with what you find?
Hypothesis and aims
• Hypothesis – state what you want to test
Diabetes can be prevented in individuals at high risk of developing type 2 diabetes by a group program using diet and exercise
• Aims – to show
1. That diabetes risk is reduced more than by usual care
2. That the high risk identification process works
3. That group programs are feasible
4. That the program is cost effective
Hypotheses and Aims
• Hypothesis
Rounding by nurses and assisting patients to the bathroom reduces falls at Western Health
• Aims
1).Compare rounding and assistance in intervention vs matched control wards
2).Compare number of falls per bed days in intervention vs matched control wards
Methods
• Subjects - inclusions & exclusions- informed consent
• The intervention and or investigation
• The measurements you need to make lab and other
• The records you need to access
• The data collection forms & recording procedures
• The questionnaires – are they validated?
• Time lines for individual subjects & for the study
• What else?
Implementation & resources
• Do you have Time
Staff
Money
Support from your department – colleagues
• Ethics approval
QA – audits
Low risk – minor interventions – little risk of harm
High risk – new interventions – RCTs – possible harm
Why do we need Ethics approval?
• Protection of rights/privacy of human individuals involved in research
• Publication/dissemination
• Safeguard researchers and their organisation
• Why publish?
– Ethical requirement of people’s time and burden
– Global change, allow others to benefit
– History – if it is not recorded, was it done?
QUALITY
ASSURANCE
LOW RISK
RESARCH
HIGH RISK
RESEARCH Study Design Retrospective medical audit of
current practice Prospective study comparing
"standard of care“ or detailed
observational study
Prospective study comparing
"standard of care" vs
intervention
Questionnaire based
research Questionnaires/survey of
treatment group Patients group - survey of
patients outside "usual care"
Data Storage 12mths 5 years 5 years/ Clinical Trial 15 years Consent Consent or waiver of consent
Usually not required
Consent or waiver of consent
(data use related to purpose of
collection)
Participants able to consent for
themselves
Patients unable to consent for
themselves or waiver of
consent (data use not related
to purpose of collection)
Data Identifiability Data de-identified or non-
identifiable Collect and use identifiable
data Collect, use and release of
identifiable data. Databases.
Tissues and Genetics Intervention & Impact risk to
participants Minimal or none Minimal Participants - high impact,
unable to consent and/or
"vulnerable" group e.g.
Children; Pregnant women;
People with a cognitive
impairment, an intellectual
disability or a mental illness
RISK Negligible Inconvenience
Low Distress
High Harm
QA Protocol key points
• Literature review/background/justification
• Aims/questions to be answered
• Participant eligibility/data sources
• Procedure (how will patients be approached)
• Outcome measures (what, how measured)
• Planned data analysis
Research outcomes Discussion
• Results
• Analysis
• Conclusions & implications
• Presentation
• Publication
• Dissemination & implementation in practice
• Evaluation – New research questions
Prevalence of Diabetes and IGT in China
0
1
2
3
4
5
1980 1989 1994 1996
DM
IGT
DM
IGT%
1996: 11 provinces / cities; age 20 - 75 yrs; n = 40,000
1989: 3 provinces / cities in Northern China
Chen JL et al, CMA Reports 1999:289-293
Figure 1
Hong Kong Cardiovascular Risk Factor Prevalence Study
1995-1996
• 7730 Computer assisted telephone interviews CATI
• 2900 adults aged 25 - 74 years attended by invitation
• Representative population sample
• Fasting & 2 hour glucose - 75g OGTT
• Comprehensive demographic, social, dietary (1010), anthropometric & laboratory data
• 2748 complete data sets
Hong Kong Cardiovascular Risk Factor Prevalence Study
1995-1996
• 7730 Computer assisted telephone interviews CATI
• 2900 adults aged 25 - 74 years attended by invitation
• Representative population sample
• Fasting & 2 hour glucose - 75g OGTT
• Comprehensive demographic, social, dietary (1010), anthropometric & laboratory data
• 2748 complete data sets
HK Adult Dietary Survey
• Dietary and nutrient intake
• Dietary practice questionnaire based on Ministry of Health Food Consumption in Singapore in 1993
• Food Frequency Questionnaire using illustrated food items and serving sizes - seven categories
HK Adult Dietary Survey- Food Frequency Questionaire
• Rice/bread/pasta (16 items)
• Vegetables (64 items) & Fruits (26 items)
• Meat (39 items) & Fish (31 items)
• Eggs (7 items)
• Dimsum/snacks(42 items)
• Beverages (38 items) & soups (10 items)
• Oil/salt/sauces
HK Prevalence of Current Smokers
0
5
10
15
20
25
30
35
40
25-
29
30-
34
35-
39
40-
44
45-
49
50-
54
55-
59
60-
64
65-
69
70-
74
Females
Males
HK Diabetes Prevalence
0
5
10
15
20
25
30
25-34 35-44 45-54 55-64 65-74
Female
Male
HK IGT Prevalence
0
5
10
15
20
25
30
25-34 35-44 45-54 55-64 65-74
Females
Males
Topic Presenters Department Date Presenting Site
Footscray VC Site
Time
Introduction to Clinical Research
Prof Edward Janus General Medicine 12 Feb 15 Auditorium WCHRE, Sunshine
NONE 10:00AM-11:00AM
Research Ethics & Governance
Mr Bill Karanatsios Office for Research 26 Feb 15 Lecture Theatre WCHRE, Sunshine
Padua 10:30AM-11:30AM
Evaluating the literature TBC TBC 12 Mar 15 Auditorium WCHRE, Sunshine
Padua 10:30AM-11:30AM
Writing a research proposal
Dr Lizzie Skinner Physiotherapy, WH 02 Apr 15 Auditorium WCHRE, Sunshine
Mavis Mitchell 12:30PM-1:30PM
Beginners statistics: Study Design
Dr Emily Karahalios WH/UoM 16 Apr 15 Auditorium WCHRE, Sunshine
Mavis Mitchell 12:30PM-1:30PM
Using Excel for research Dr Lizzie Skinner Physiotherapy, WH 30 Apr 15 Auditorium WCHRE, Sunshine
Mavis Mitchell 12:30PM-1:30PM
Mixed Methods: Quantitative & Qualitative
Prof Paul Bennett Deakin School of Nursing
14 May 15 Auditorium WCHRE, Sunshine
Mavis Mitchell 12:30PM-1:30PM
Referencing and EndNote TBC (Referencing) Lynn Higgins (Endnote)
Office for Research / Library
28 May 15 Lecture Theatre WCHRE, Sunshine
NONE 12:30PM-1:30PM
Making Sense of your results
Dr Emily Karahalios WH/UoM 11 Jun 15 Auditorium WCHRE, Sunshine
NONE 10:30AM-11:30AM
Getting your work published
TBC TBC 02 Jul 15 Auditorium WCHRE, Sunshine
Padua 10:30AM-11:30AM
Writing Abstract for Research Week/ Conferences
TBC TBC 16 Jul 15 Auditorium WCHRE Mavis Mitchell 12:30PM-1:30PM
Western Health Research Training Workshops 2015 Please contact the Office for Research for any queries: Tel:(03) 8395 8073; E: research@wh.org.au
top related