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