CAHS Research Education Program Research Skills Seminar Series (08) 6456 4585 [email protected]https://cahs.health.wa.gov.au/ResearchEducationProgram CAHS Research Education Program Research Skills Seminar Research Fundamentals 5 th February, 2021 Presented by Associate Professor, Sue Skull Head, Research Education Program Deputy Director, Department of Research, CAHS
This document is posted to help you gain knowledge. Please leave a comment to let me know what you think about it! Share it to your friends and learn new things together.
Research Education Program | Research Skills Semi nar Series
Research FundamentalsQuestion and Protocol Development
5th February, 2021
Presented by Associate Professor, Sue SkullHead – Research Education Program
2
"Research is the process of going up alleys to see if they are blind.”- Marston Bates
1. Why do research and how to we approach it?
2. The research team and responsibilities
3. Developing ideas ���� a clear question ����
4. Developing a high quality protocol
OVERVIEW
3
Why do research?How do we approach it?
“Research is to see what everybody else has seen, and to think what nobody else has thought”
- Albert Szent-Gyorgyi (Nobel Prize for Medicine, 1893-1986)
4
Why do research?
• To obtain quality evidence
• To answer questions that matter
• To make a difference
“Really, I’m fine. It was just
a fleeting sense of purpose –
I’m sure it will pass.”
5
Next Steps
How do we approach research?
6
• Background Review• Research Question• Specify Objectives• Methodology• Pilot Testing• Approvals• Budget
• Data Collection• Data cleaning• Analysis• Critical interpretation• Report Results
• Make a difference!
Time spent here is time well spent
The Research Pathway
21/01/2021
2
7
The Research Pathway – “Before” • Background review• Stakeholder involvement• Clarify research question• Specify objectives• Develop methods• Pilot test• Approvals• Budget
Involvement may start at any phase.“I’ve got some great data”Get help as early as possible – and often 8
The Research Pathway – “During”• Data collection
• Refine processes – if needed - and resubmit to ethics
• Study monitoring: procedures, training, data management
• Ongoing dialogue with participants, stakeholders
• Data cleaning
• Interim data analysis - sometimes
9
The Research Pathway – “After”• Data cleaning++
• Data analysis
• Critically interpret and summarise findings
• Communicate findings
• Change policy/practice
• New directions?
• Save the World!
10
The Research Team• Investigators• Key stakeholders• Community members*• Cultural advisors• Epidemiologist• Project manager• Data manager• Biostatistician• Communications team
“Scientists who publish their research have an ethical responsibility to ensure the highest standards of research design, data collection, data analysis, data reporting, and interpretation of findings; there can be no compromises because any error, any deceit, can result in harm to patients as well as harm to the cause of science”
General Ethical PrinciplesJustice• Fair selection of participantsBeneficence• Consider welfare and interest of participants• Risk vs Benefit, equipoise• Awareness of social implicationsRespect• Autonomy of individuals• Protection of vulnerable groups
“In matters of truth and justice, there is no difference between large and small problems, for issues concerning the treatment of people are all the same” - Albert Einstein 20
Research Merit• Important question
– e.g. high risk, high volume, high cost– Aligned with research priorities*– Potential benefit– Contribution to knowledge/wellbeing– After throrough literature review
• Appropriate methods*• Appropriate skills
“It seems to never occur to fools that merit and good fortune are closely united”- Johann Wolfgang von Goethe
Example – A prediction question[Population]In adults with a previous seizure…
[Indicator]…what risk factors
[Comparator]…
[Outcome]…predict seizure recurrence
[Time]…over a 1 year period
35
Example – An intervention question[Population]In children with otitis media…
[Indicator]…does antibiotic therapy delayed by 48h
[Comparator]…compared with usual therapy
[Outcome]…increase duration of pain or bulging of the ear drum
[Time]…within 10 days of onset of symptoms
36
Example – A qualitative question[Population]In families with a child with rare disease X…
[Indicator]…what are the barriers and facilitators
[Comparator]…
[Outcome]…for obtaining a timely diagnosis
[Time]…
21/01/2021
7
37
Choosing the right study design
38
Broad approaches
• Qualitative Methods
• Quantitative Methods
• “Mixed” Methods
39
Features of different methodsQuantitative• Specify expected outcome• Meticulously study design• Numbers, statistics• Objective: precise measurement
• Classify, count, statistically explained• Distilled information , can miss context• Potentially larger numbers• Test and generate hypotheses• Efficient
Qualitative• General idea of outcome• Design options or can emerge• Words, pictures, objects• Subjective: interpret observations
• Complete detailed descriptions• Rich information• Small numbers• Generate hypotheses• Time consuming
Relevant Seminar 202126 Nov – Qualitative Research
https://20211126.eventbrite.com.au40
Which method?
Qualitative vs Quantitative vs Mixed?
What to use depends on your question…
41
Choosing the right Study Design
• Certain questions lend themselves to certain designs
• A clear question will then provide the options
• Balance “best” design with feasibility, resources, ethics
Example – A prediction question[Population]In adolescents with a previous seizure…
[Indicator]…what risk factors
[Comparator]…
[Outcome]…predict seizure recurrence
[Time]…over a 1 year period
46
Example – An intervention question[Population]In children with otitis media…
[Indicator]…does antibiotic therapy delayed by 48h
[Comparator]…compared with usual therapy
[Outcome]…increase duration of pain or bulging of the ear drum
[Time]…within 10 days of onset of symptoms
47
Example – A qualitative question[Population]In families with a child with rare disease X…
[Indicator]…what are the barriers and facilitators
[Comparator]…
[Outcome]…for obtaining a timely diagnosis
[Time]…
48
Protocol Development
21/01/2021
9
49
The Study Protocol…• A plan or roadmap outlining everything you will do
– What, why, who, how
• For study team, funders, ethics..
• Background including question, justification
• Methods
• Budget
• Ethics
• More…
50
Putting together a Protocol – Basics• Outline 1-2 pages of headings � expand
• Get advice – not just for the statistics – early and often
• Be prepared to make this an iterative process
• Remember you have a team
• Can you cut any corners? Standard approaches?‒ Data collection forms
‒ Data management
‒ Study monitoring
‒ Community involvement
• Must be a joy to read ☺
51
BackgroundOrder of key areas is important
• Problem – why are we here
• Evidence – what we know / don’t
• Justification – impact
• Clear statement of research question
• Objectives / Aim / Hypotheses
Who can help? Librarian/Informationist, Content Experts, Epidemiologist
52
Specific Objectives• Primary objectives
• Secondary objective(s)
• Must clearly match your research question
• Become the basis of 1o and 2o analyses
53
Methods
Garbage in = Garbage outGarbage in = Garbage outGarbage in = Garbage outGarbage in = Garbage out
Who can help? Epidemiologists, other researchers, data managers, biostatisticians, community experts
54
Methods Overview• Study design• Stakeholder involvement• Setting• Participants• Definitions – exposure, outcomes, tests• Analysis plan, statistical methods, sample size• Data collection plan and instruments• Data management plant• Monitoring and management plan including training• Piloting• Timelines, budget, communications / translation plan• Ethical considerations and application
21/01/2021
10
55
Community/Site Involvement and Support
• Include key stakeholders – why?• Consult early eg prior to finalising Q, data, study sites etc• Information sessions• Seek input to design• Obtain site support• Ethics / Governance requirements
– Site specific assessment form, or– Health access request form
Who can help? Other researchers,community leaders,communications team
56
Analysis Plan• No idea?
– Write your paper titles
– Write abstracts
– Identify key variables
– � Collect the data you need
• Answer the research question(s)!• Consistency with study design• Outline tables/graphs• Use appropriate statistical tests and models• Sample size calculations
Who can help?
Epidemiologist, Biostatistician
57
The Analysis Plan (Quantitative)
Simple Descriptive Data• Participant/case profile
• Denominator Data
• Baselines Tables
Univariate Analysis• 1o & 2o Outcomes
• Subgroup Analyses
Multivariate
Analyses
58
Data Collection and Entry
Who can help? Epidemiologist, Audit Specialist,
Data Manager, other Researchers
Relevant Seminars 2021
14 May – Survey Designhttps://20210514.eventbrite.com.au
06 Aug – Data Managementhttp://20210806.eventbrite.com.au
Instrument Design• Multiple iterations usual
• Unique identifiers
• Simplify: skips, codes,
pre-set categories
Database• Unique identifiers
• Compulsory fields
• Ranges, validation
• Security
Pilot!!
59
Data Management• Good Clinical Practice requirements• Data Management Plan (monitor)
– Collection– Recording– Security– Filing, version control– Backup– De-identification– Variable names, data dictionaries– Storage
• Define data entry and analysis packages– E.g. REDCap, Qualtrix, Epi Info, Stata, R etc, NOT Excel
Who can help? Data Manager, Epidemiologist, other researchers
• Include in protocol if feasible• Iron out unforeseen issues• Streamline processes• Improve data collection instruments• Estimate sample size• Improve funding chances• Revise and resubmit to ethics
"There are no secrets to success. It is the result of preparation, hard work, and learning from failure." - Colin Powell
Absolutely Essential
Who can help?
Other researchers
62
Timelines• Study design including revisions• Ethics processes• Site negotiation / community consultation• Staff hiring and training• Database development• PILOTING• Subject recruitment• Data collection period• Data entering, cleaning, analysis• Report writing and feedback• Policy development/changes in practice
Use flow diagrams, Gantt charts, Project management software
Be realistic!
63
The BudgetAn incomplete budget will mean your project is unlikely to be successfully completed. This has implications for your participants, you as a researcher, and your institution.
Communication Planning• During and after the project
• Written and oral
• Outline papers and authorship upfront
• Summary reports
• Conferences, seminars
• Community feedback
“The single biggest problem in communication is the illusion that it has taken place.”
- George Bernard Shaw
Who can help?
Experienced Researchers,
Media Training Officers,
Communications Team
68
Policy and Practice Implications• May not be what was originally assumed• Must be budgeted for and followed through
MAKEa difference
Not to be forgotten as time and resources run out!
Who can help?Key stakeholders,
Policy experts
69
Take home messages• Be kind to ideas• Have a clear, worthwhile question• Put a good team together• Be aware of your responsibilities• Choose a research design that fits• Protocol detail matters – refine, refine, refine• Effort early = effort saved• Pilot (everything)• Seek help early and often
70
Enjoy your research!
And remember…
Be efficient and avoid the pitfalls through good design and planning
71
Questions? Comments?
72
19 Feb Scientific Writing with Sue Skull
05 Mar Good Clinical Practice with Natalie Barber
19 Mar Research Governance with Sunalene Devadason
Child and Adolescent Health Service Department of Re searchDepartment of Health, Government of Western Austral ia
Copyright to this material produced by the CAHS Research Education Program, Department ofResearch, Child and Adolescent Health Service, Western Australia, under the provisions of theCopyright Act 1968 (C’wth Australia). Apart from any fair dealing for personal, academic,research or non-commercial use, no part may be reproduced without written permission. TheDepartment of Research is under no obligation to grant this permission. Please acknowledgethe CAHS Research Education Program, Department of Research, Child and AdolescentHealth Service when reproducing or quoting material from this source.
All seminars are held from 12:30-1:30pm in the Auditorium on Level 5 at Perth Children’s Hospital and topics may be subject to change - email notice will be provided. All corresponding handouts are regularly revised and updated with attendance certificates available upon request.
2021 Research Skills Seminar Series Schedule Date Topic Presenter
S1 Feb 5 Research Fundamentals A/Prof Sue Skull
S2 Feb 19 Scientific Writing A/Prof Sue Skull
S3 Mar 5 Introduction to Good Clinical Practice Natalie Barber
S4 Mar 19 Research Governance Sunalene Devadason
S5 Apr 30 Building Your Personal Brand As A Researcher Dr Kenneth Lee
S6 May 7 Using REDCap for Data Capture and Management Telethon Kids Biometrics Team
S7 May 14 Survey Design and Techniques A/Prof Sue Skull
S8 May 28 Getting the most out of Research Supervision Prof Jonathan Carapetis AM
S9 Jun 18 Introductory Biostatistics Dr Julie Marsh
S10 Jun 25 Sample Size Calculations Dr Julie Marsh
S11 Jul 23 Knowledge Translation Fenella Gill
S12 Jul 30 Consumer and Community Involvement Anne McKenzie AM
S13 Aug 6 Data Collection and Management A/Prof Sue Skull
S14 Aug 13 Media and Communications in Research Elizabeth Chester
S15 Aug 27 Oral Presentation of Research Results A/Prof Sue Skull
Writing is the most used channel for communication of ideas, research, and findings. Being able to have quality and effective scientific writing is a fundamental part of successful research translation. This seminar provides a practical overview of scientific writing; including principles of good writing, how to get started, article structure and organisation, how to negotiate authorship, and the publication process.
The Research Skills Seminar Series is part of the Research Education Program presented by the
Child and Adolescent Health Service, Department of Research. Seminars are hosted by WA Department of Health.
Good Clinical Practice (GCP) provides the ethical and scientific standards and guidelines by which all research is conducted, and is a requirement for all researchers to know and apply. This seminar covers key components of GCP including responsibilities, approvals, informed consent, document and data management, and reporting of adverse effects.
The Research Skills Seminar Series is part of the Research Education Program presented by the
Child and Adolescent Health Service, Department of Research. Seminars are hosted by WA Department of Health.
Natalie Barber is the Head of Research Governance and Platforms at the Telethon Kids Institute. She has vast experience in running of clinical trials and human research from the Pharmaceutical Industry and the NHS in the UK. She is an experienced teacher of GCP and is looking forward to the challenge of covering this topic.
All new research project applications must cover requirements for both ethics and governance. This seminar focuses on the general principles and responsibilities related to research governance, and provide practical tips for preparation of governance applications. It also covers recent changes to state and national governance frameworks and implications for researchers.
The Research Skills Seminar Series is part of the Research Education Program presented by the
Child and Adolescent Health Service, Department of Research. Seminars are hosted by WA Department of Health.
Associate Professor Sunalene Devadason is the Coordinator of Graduate Research at the UWA School of Paediatrics and Child Health (SPACH). She has extensive experience on both sides of research governance process as a reviewer and a researcher.