grade 4 physiotherapist (icu/research) elizabeth.skinner ...€¦ · research proposal structured...
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Dr. Elizabeth Skinner
Grade 4 Physiotherapist (ICU/Research)
elizabeth.skinner@wh.org.au
Honorary Research Fellow
The University of Melbourne
Monash University
Keep It Simple, pleaSe
If you can treat patients, you can write a research proposal Structured assessment
Structured proposal
If you do it properly you can get another
publication
6-10 A4 pages
We are too busy to reinvent the wheel
Experience = done it before
Access them!
All disciplines
WH Office for Research
Quality or research? Not everything may require a formal proposal
Seek help early Ask the right questions
Study design Appropriate for your question
Reporting checklists Cheat sheets
Moher et al., 2010, BMJ 340:c869
Vandenbroucke et al., 2007, PloS Medicine: 4:1628-1654
Liberati et al., 2009, BMJ 339:b2700
Tong, Sainsbury and Craig, 2007: Int J for Qual Health Care 19:349-357
Title/topic
Investigators
Rationale
Research Questions/Aims/Hypotheses/Objectives
Design and Methodology
Study design, participants, setting, procedure, groups (if any), outcome measures, analyses
Operational requirements
Feasibility, timelines, budget
Ethical Considerations (not covered today)
Designate a project leader
Data
Already available
Part of your role (or that of your team)
Multi-disciplinary/multi-site involvement
Cross-over with research questions (PICO)
Patient/population
Intervention
Comparator/Control
Outcome
(T)ime/timing
Include study design in the title
Informative titles with publication
Have you ever:
Supervised a student or junior staff member?
Discussed best patient management?
Been unsure about your treatment choice?
Noticed clinical patterns?
Wondered about patient progression (or lack of)?
Wondered about other clinician choice of
treatment?
Been questioned about your treatment choice?
When should we refer patients to you after
they aspirate oral intake?
What’s the difference in the role of physio
between ICU and GEM?
You should focus on passive range of motion
rather than treating the patient’s lungs.
How quickly should we progress cuff
deflation in a patient with tracheostomy?
Build your team Complementary skills
Collaboration
Complementary resources
Role definition and allocation of tasks
Interest and time availability
Engagement from management
Open discussion about authorship (criteria)
At least one investigator with research experience
Identify and develop your topic
Find background information
Systematic/literature review; evaluate
Catherine Shore-Lorenti (slides online)
Find the gap
What do we know?
What don’t we know?
Introduce the health problem/area
Why is it important?
What is the burden?
Is this a strategic priority?
What has previously been done to address the problem and what are the limitations?
Why might the current intervention/approach work
SEMANTICS
Questions
Aims (primary and secondary)
Hypotheses (including the null)
Objective
PICO(T) format useful
Aim/Objective
The aim/objective is to establish whether mobilisation compared to usual care in ventilated critically ill patients reduces the duration of ventilation
Hypotheses
The primary hypothesis is that mobilisation will shorten the duration of ventilation in ventilated critically ill patients compared to usual care
Null = no difference
Some common designs Phases of clinical trials
▪ Phase I - Safety, feasibility
▪ Phase II - Efficacy (can it work? Pilot RCT)
▪ Phase III - Efficacy/Effectiveness (large-scale)
▪ Phase IV - Monitor effectiveness in real-world
Observational cohort/case-control study
Cross-sectional survey
Feasibility, safety, pilot study
Randomised controlled trial
Consider the levels of evidence and hierarchy
Data collection
Prospective
Retrospective
Observational/intervention
Longitudinal, cross-sectional
Careful consideration/answer the question
Can it work?
Efficacy
Does it work?
Effectiveness
Real-world
How much does it cost and is it worth it?
Cost-effectiveness
Common sources of bias
Randomization sequence, allocation
(concealment)
Lack of blinding of patients, providers,
outcome measures, outcome adjudicators
Group contamination
Progression of standard care
Lack of adherence to the protocol
Proportion of outcome data (missing)
Setting
Participants
Procedure
Screening
Recruitment
Groups/intervention
Outcomes
Planned analyses
Sample size
Location
Clinical
University
Dates
Recruitment
Data collection
Population
Inclusion and exclusion criteria
Consider number
More robust the research findings
Less generalizable the results
Sample size
Convenience, existing data
Patient flow through the study
Screening and recruitment Consecutive
Randomization Next slide
Outcome measure assessment
Time periods, follow-up
Allocation
Sequence generation
Allocation concealment
Implementation
CONSORT 2010 Flow Diagram
Assessed for eligibility (n= )
Excluded (n= )
Not meeting inclusion criteria (n= )
Declined to participate (n= )
Other reasons (n= )
Analysed (n= )
Excluded from analysis (give reasons) (n= )
Lost to follow-up (give reasons) (n= )
Discontinued intervention (give reasons) (n= )
Allocated to intervention (n= )
Received allocated intervention (n= )
Did not receive allocated intervention (give
reasons) (n= )
Lost to follow-up (give reasons) (n= )
Discontinued intervention (give reasons) (n= )
Allocated to intervention (n= )
Received allocated intervention (n= )
Did not receive allocated intervention (give
reasons) (n= )
Analysed (n= )
Excluded from analysis (give reasons) (n= )
Allocation
Analysis
Follow-Up
Randomized (n= )
Enrollment
Intervention (TIDieR)
Describe in detail
Remember school science – repeatable!
Use figures/flow-charts
Protocols of administration
Training of staff
May need piloting
Comparator/Control/Usual care
Also known as “standard care”
Describe in detail
Ensure sufficient “separation” between groups
Consider documenting as part of pre-trial audit
Don’t assume you know what it is
Primary (powered for) Secondary
Measurement properties
Reliable
Valid
Sensitive, responsive (measuring change)
Clinical important differences
Protocols for administration
Assessor blinding
Critically important especially for large-scale
clinical trials or randomised trials
Can be difficult to achieve in clinical research
Worth seeking funds for this component
Utilising other team members not involved in
the project
Feasibility
Record compliance/unblinding
Process measures
Compliance
Acceptability to consumers
Adherence
Protocol/Intervention
Adverse events
Must be reported to the HREC
Organisational risk reporting
Focus on primary outcome measure
Description of approach
Access to statistical programs
Consider funding or accessing external expertise
Statistician as part of the research team
Screening and cleaning the data
Normality of your distributions
Planned comparisons (a priori)
Number of groups (dependent, independent)
Change over time
Regression (logistic, simple, multiple)
Parametric and non-parametric
Between-group, within-group
Feasibility
Can the trial be performed?
Staffing, resources, equipment, burden
Timelines
It always takes longer than you think!
Plan for HREC
Training
Required? Process?
Budget
Map out requirements
Map existing resources
Research team planning
In-kind support
Internal grants
External competitive grants (seed)
External competitive grants (NHMRC)
Per milestone can be a helpful strategy
Give time to get money
Align with ethical considerations
Genetics
Radiological exposure
Drug trials
Ethical considerations
Other considerations?
YOUR
PATIENTS
(and your profession)
NEEDS YOU!
Consider existing
Templates
Materials
Checklists
Manuscripts
Structure is the key
Must be replicable
Contact
0419 101708
elizabeth.skinner@wh.org.au
@lizzieskinner (Twitter)
Elizabeth Skinner (ResearchGate)
Western Health Researchers join
ResearchGate!
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 Miss Catherine Shore-Lorenti
UoM
19 Mar 15 Lecture Theatre WCHRE, Sunshine
Mavis Mitchell
12:30PM-1:30PM
Writing a research proposal
Dr Lizzie Skinner Physiotherapy, WH Wednesday 01 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 Bill Karanatsios (Referencing) Eve Hutcheon (Endnote)
Office for Research / Library
28 May 15 PBL 6, Level 1, 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
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