Research Fundamentals Question and Protocol Development Associate Professor Sue Skull Head, CAHS Research Education Program Deputy Director, Department of Child Health Research, CAHS 14 February 2020 Research Skills Seminar Series | CAHS Research Education Program Research support, development and governance
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Research Fundamentals Question and Protocol Development
Associate Professor Sue Skull Head, CAHS Research Education Program
Deputy Director, Department of Child Health Research, CAHS
14 February 2020
Research Skills Seminar Series | CAHS Research Education Program
“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 harm to the cause of science”22
General Ethical Principles
Justice• Fair selection of participants
Beneficence• Consider welfare and interest of participants
• Risk vs Benefit, equipoise
• Awareness of social implications
Respect• 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 22
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Research Merit• Important question
– After appropriate literature review
– Potential benefit
– Contribution to knowledge/wellbeing
– High risk, high volume, high cost
– Aligned with research priorities*
• Appropriate methods*
• Appropriate skills
“It seems to never occur to fools that merit and good fortune are closely united”Johann Wolfgang von Goethe
23
This is NOT your research team
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Feasibility
7
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Feasibility
• Clear question, objectives, outcome measures
• Appropriate study design
• Adequate number of subjects
• Appropriate expertise
• Adequate resources
• � Useful/complete/high quality data
25 26
Clinical Relevance
• Who cares?
• Is this an important problem: personally,
locally, internationally?
• What would your research add?
• Has it been done before?
• What is the likely impact on policy and
practice?
“It is a good morning exercise for a research scientist to discard a pet hypothesis every day before breakfast.It keeps him young.” Konrad Lorenz
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Importance of a good review
Further Reading
Discussion with Experts/Peers/Community
Review Logistics/Resources etc.
Can lead to a whole new question!
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Literature Review
• Constantly evolving technology
• Informationists / medical librarians can assist with:
– Literature review
– Automated searches, alerts
– Critical appraisal
– Reference packages e.g. EndNote
• Do a course, update regularly
• Depth depends on project scope, resources
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8
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Basic Critical Appraisal Skills – Essential
Your goal? To determine:
1. Existing knowledge � your project’s contribution
2. Is there a definitive study out there already?
3. Find the “highest level” studies first
4. Ideas for design, data
Critical appraisal is the process of carefully and systematically examining research
to judge its trustworthiness, its value and relevance in a particular context.
(Burls, 2009)
Relevant Seminars 2020:16 Oct – Critical Appraisal of Scientific Literature
23 Oct – Statistical Tips for Interpreting Scientific Claims30
Peer Review
• No excuses! Email, skype, phone
• Generally others are pleased to be asked
• Pay-off…
– Incomplete studies
– Unpublished papers
– Abstracts at recent conferences
– Personal experience
– Insight on implications
– Collaboration
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Community Engagement
• Essential and required
• Pay-off huge…
– Personal experience
– Insights ++ on
• Relevance, Practicalities
• Implications, Data for collection
• Interpretation of results, Plain language
– Advocacy: funding, dissemination
– Collaboration31
Community Engagement Seminar
Fri June 26th or
https://pch.health.wa.gov.au/Research/Fo
r-researchers/ResearchEducationProgram
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Research Idea Development Support
• Early input � meaningful, well-designed projects
• Get 1:1 advice wherever possible
• Research support
– Research support officers
– Epidemiologists
– Statisticians etc
• Idea development forums
Ensure fit with site research agenda32
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So assuming your idea is a good one…
�Clarify and Develop your Research Question
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PICOT: Clearly Define a Question• Simple evidence-based Clinical Practise tool
• Provides structure with 5 key components
• Idea � answerable research question � design, protocol
Copyright to this material produced by the CAHS Research EducationProgram, Department of Child Health Research, Child and AdolescentHealth Service, Western Australia, under the provisions of the CopyrightAct 1968 (C’wth Australia). Apart from any fair dealing for personal,academic, research or non-commercial use, no part may be reproducedwithout written permission. The Department of Child Health Research isunder no obligation to grant this permission. Please acknowledge theCAHS Research Education Program, Department of Child HealthResearch, Child and Adolescent Health Service when reproducing orquoting material from this source.
2 RESEARCH BASICS – ADDITIONAL NOTES AND RESOURCES
2.1 FORMULATING A RESEARCH QUESTION
Aslam S, Emmanuel P. Formulating a researchable question: A critical step for facilitating good clinical research. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3140151/
PICO: Formulate an answerable question. Cochrane Collaboration. http://learntech.physiol.ox.ac.uk/cochrane_tutorial/cochlibd0e84.php
Asking Focused Questions. Centre for Evidence‐Based Medicine, University of Oxford. http://www.cebm.net/index.aspx?o=1036
2.2 LITERATURE REVIEW
Approaches to your Literature Review ‐ E‐Learning Research Methods BMJ. http://www.erm.ecs.soton.ac.uk/theme3/approaches_to_your_literature_review_evaluation.html
Accessing the PubMed database (and other health resources): http://www.ncbi.nlm.nih.gov/pubmed
PubMed tutorials are at: – http://www.nlm.nih.gov/bsd/disted/pubmed.html – https://learn.nlm.nih.gov/rest/training‐packets/T0042010P.html
Finding the Evidence. Centre for Evidence‐Based Medicine, University of Oxford. http://www.cebm.net/finding‐the‐evidence/
Levels of Evidence. Centre for Evidence‐Based Medicine, University of Oxford. http://www.cebm.net/index.aspx?o=5653
Critical Appraisal Tools. University of South Australia. http://www.unisa.edu.au/Research/Sansom‐Institute‐for‐Health‐Research/Research/Allied‐Health‐Evidence/Resources/CAT/
2.3 STUDY DESIGN
Ioannidis JPA, Greenland S, Hltaky MA et al. Increasing value and reducing waste in research design, conduct, and analysis. Lancet 383: 166‐75. Jan 14 http://www.thelancet.com/journals/lancet/article/PIIS0140‐6736(13)62227‐8/fulltext
Aslam S, Georgiev H, Mheta K, Kumar A. Matching research design to clinical research questions. Indian J Sex Transm Dis. 2012 Jan‐Jun; 33(1): 49–53. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3326852/
Checkoway H, Pearce N, Kriebel D. Selecting appropriate study designs to address specific research questions in occupational epidemiology. Occup Environ Med. 2007 September; 64(9): 633–638. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2092571/
Study designs: strengths and weaknesses. Centre for Evidence‐Based Medicine, University of Oxford. http://www.cebm.net/?o=1039 http://www.cebm.net/blog/2014/04/03/study‐designs/
Epidemiological research: the six types of study design you need to know. Student BMJ 2001;09:261‐304 August ISSN 0966‐6494 http://www.vhpharmsci.com/decisionmaking/Therapeutic_Decision_Making/Intermediate_files/Epidemiological%20research‐studentBMJ.pdf
2.4 PROJECT PLANNING
Eston RG, Rowlands AV. Stages in the development of a research project: putting the idea together. http://bjsm.bmj.com/content/34/1/59.full
Developing a project plan: Flinders University Planning and Evaluation Wizard. – http://som.flinders.edu.au/FUSA/SACHRU/PEW/pep_intro.htm – http://www.flinders.edu.au/medicine/sites/pew/developing‐a‐project‐and‐evaluation‐
plan/planning‐zone/
2.5 WRITING A RESEARCH PROTOCOL
Guide for writing a Research Protocol for research involving human participation. WHO. http://hub.ucsf.edu/protocol‐development
Recommended Format for Writing a Research Protocol. WHO http://www.who.int/rpc/research_ethics/format_rp/en/
Writing an Effective Research Proposal. Verheof MJ, Hilsden RJ. University of Calgary, Alberta, Canada. 2004 http://www.ais.up.ac.za/health/blocks/block2/researchproposal.pdf
2.6 DATA MANAGEMENT
Note: The Research Skills Seminar Series has a seminar on Data Management for which materials are available. Data Collection and Management seminar will be presented 31st July 2020.
WA Health Research. Governance Policy and Procedures Handbook. http://www.health.wa.gov.au/CircularsNew/attachments/724.pdf Also see the Research Governance Service website for WA for additional information: https://rgs.health.wa.gov.au/Pages/Home.aspx
Souhami R. Governance of research that uses identifiable personal data. http://www.bmj.com/content/333/7563/315
2.7 TRANSLATING RESULTS INTO ACTION
Note: The Research Skills Seminar Series will present a seminar on Knowledge Translation on 22 May 2020.
How to put the evidence into practice: implementation and dissemination strategies NHMRC 2000 CP71 http://www.nhmrc.gov.au/_files_nhmrc/publications/attachments/cp71.pdf
How to use the evidence: assessment and application of scientific evidence. NHMRC 2000 CP69. http://www.nhmrc.gov.au/guidelines/publications/cp69
Research Skills Seminar Series 2020CAHS Research Education Program
Research GovernancePrinciples and Practical GuidanceFriday, 21 February 2020 | 12:30 – 1:30PM
Want to understand better how your
Governance applications go through the
Research Governance office for review?
Confused as to what they are looking for?
This seminar will focus on the general
principles and responsibilities related to
research governance, and provide
practical guidance for preparation of
governance applications. It will also
update you on recent changes and
upcoming developments relevant to this
process.
*Online access via Scopia available
*Hosted VC Sites Include:CAHS – Community Health (WASON)
W: pch.health.wa.gov.au/Research/Go to “For Researchers”then “Research Education Program”https://pch.health.wa.gov.au/Research/For-researchers/ResearchEducationProgram
The Research Skills Seminar Series is part of the Research Education Program, Department of Child Health Research,Child and Adolescent Health Service, WA Department of Health. Seminars are hosted by WA Department of Health.
Perth Children’s HospitalPCH Auditorium
Level 5(Pink or Yellow lifts)
15 Hospital Ave, Nedlands
Register Online
ResearchEducationProgram.eventbrite.com
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.
Introduction to Good Clinical PracticeFriday, 6 March 2020 | 12:30 – 1:30PM
All researchers conducting human research must have undertaken Good Clinical Practice (GCP) training. With regular updates to GCP, it is ideal to take refresher training to aid in keeping up to date with current requirements.
This seminar is for those unsure what GCP entails and would like to learn more or just wanting a refresher. The seminar will provide a basic understanding of GCP and will cover: responsibilities, approvals, informed consent, document and data management, safety reporting, andreporting adverse effects.
Natalie Barber is the Head of Research Governance and Platforms at Telethon Kids Institute. Before moving to Australia 6 years ago, Natalie worked within the Pharmaceutical Industry and the NHS in the UK.
Natalie Barber
She is an experience teacher of GCP and has vastexperience in running clinical trials and human researchwithin multiple disciplines of research and has a breadthof knowledge of the Australian Regulatory landscape.
CAHS Research Education Program | Research Skills Seminar Series
Online access via Scopia available
Hosted VC Sites Include:
CAHS – Community Health (WASON)
Fiona Stanley Hospital
Joondalup Health Campus
Lions Eye Institute
Royal Perth Hospital
Further information: E: ResearchEducationProgram
@health.wa.gov.au
W: cahs.health.wa.gov.au/Research/Go to “For Researchers”Then “Research Education Program”