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?

Registries

www.anzctr.org.au

Publishing your protocol

Journals

Funding

http://www.anzctr.org.au/

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

mailto:research@wh.org.au