Linking research questions & design MEDI6302 Session 2 Linking research questions & design Sydney Broome Fremantle

Research Question Hypothesis Design Scientific Method Research ‘Materials & Methods’ © Eric J. Visser 2017 UNDA. All rights reserved

Your research question(s) should state the… …of your study. © Eric J. Visser 2017 UNDA. All rights reserved

Research Design (methods) Your research design (‘methods’) should also state the… …of your study. © Eric J. Visser 2017 UNDA. All rights reserved

Research Design A systematic plan that investigates your research question (hypothesis) as accurately & efficiently as possible. Research design is outlined in the ‘methods’ section of your paper. Outlines the ‘HOW’ (‘who’, ‘what’, ‘where’, ‘when’) of your study. Outlines the science, feasibility & logistics of your study. Important part of proposal, grant or ethics submissions. © Eric J. Visser 2017 UNDA. All rights reserved

Design is based on your research question Use the PICOT approach POPULATION (what group of people are you studying?) -Person, cohort, sample, population, database? INTERVENTION (are you making a change or intervention in your study group?) YES = Experimental trial. -Random allocation of intervention? = randomised trial. NO = Observational study. © Eric J. Visser 2017 UNDA. All rights reserved

Design is based on your research question Use the PICOT approach CONTROLS (are you controlling the research variables?) YES = Controlled trial. -(randomised) controlled trial (RCT). COMPARISONS (are you comparing groups? [but not as an RCT]) YES = Analytical study. -cohort study. -case-comparison [control] study. -cross-sectional study. © Eric J. Visser 2017 UNDA. All rights reserved

Design is based on your research question PICOT approach OUTCOMES (how will you analyse & present your data?) -Quantitatively? (using comparative statistics). -Are you using data from other studies or databases? -YES: Meta-analysis or systematic review. -Qualitatively? (using ‘descriptive’ statistics, writing a narrative report). -Mixed-methods? TIMELINES -Prospective, retrospective, longitudinal, snap-shot. © Eric J. Visser 2017 UNDA. All rights reserved

Design Classification Narrative Review Trial Case Report Case Series https://irb.research.chop.edu/sites/default/files/documents/classificationclinicalresearch_large.jpg © Eric J. Visser 2017 UNDA. All rights reserved

https://image. slidesharecdn https://image.slidesharecdn.com/3-researchdesign-120907044702-phpapp01/95/3research-design-7-728.jpg?cb=1346993283 © Eric J. Visser 2017 UNDA. All rights reserved

Research Design Hierarchy https://upload.wikimedia.org/wikipedia/commons/thumb/3/36/Research_design_and_evidence.svg/707px-Research_design_and_evidence.svg.png © Eric J. Visser 2017 UNDA. All rights reserved

© Eric J. Visser 2017 UNDA. All rights reserved https://www.health.qld.gov.au/__data/assets/pdf_file/0022/435703/lvl-of-evidence.pdf © Eric J. Visser 2017 UNDA. All rights reserved

Human Research Design WHO: population, cohort, sample, data-base, individual? WHAT: clinical or non-clinical? (e.g. social sciences). HOW: observational (study) or experimental (trial). HOW: in-vivo or in-vitro (laboratory). HOW: qualitative (descriptive) or quantitative data analysis. HOW: meta-analysis, trial, survey, narrative-review, case-based. WHERE: single centre, multi-centre. © Eric J. Visser 2017 UNDA. All rights reserved

Logistics & Feasibility WHAT resources are available for your research? WHO: research staff (expertise) & subjects (availability). WHO: cultural considerations, special groups. WHAT: equipment, facilities. WHERE: venues. HOW (much): funding, cost. HOW (long): time. © Eric J. Visser 2017 UNDA. All rights reserved

Research Design Tips Adapt (already proven) research design methods in published studies that are similar to yours (based on your literature review). Are there are research design guidelines you can use? -e.g. International Headache Society for migraine research. Look at ‘methods’ & ‘instructions for authors’ sections in journals. Outline feasibility, logistics, equipment & special skills (staff). Get advice from a statistician BEFORE designing your study. POWER your study properly. © Eric J. Visser 2017 UNDA. All rights reserved

Learning task 1 Define & understand the following terms… Glossary of terms Define & understand the following terms… Experiment Trial versus study Survey Audit Convenience sample Qualitative research Observational study Descriptive study Mixed-methods design Meta-analysis Comparator study Cohort study Narrative review Controlled trial Dependent variable Independent variable © Eric J. Visser 2017 UNDA. All rights reserved

Learning task 2 Write down your research question (session 1). Outline your research design, based on PICOT headings. -Population -Intervention -Control or Comparison group -Outcomes -Timeline © Eric J. Visser 2017 UNDA. All rights reserved

Research design statement Learning task 3 Research design statement Write a one paragraph ‘research design statement’ based on PICOT. Example The current study is a prospective randomised, controlled trial investigating the analgesic effects of ibuprofen versus placebo in a convenience sample 76 post-operative patients. Timeline Randomised Controlled Outcome Intervention Population © Eric J. Visser 2017 UNDA. All rights reserved

Writing your ‘methods’ Learning task 4 Writing your ‘methods’ section Draft a template of the main headings & sub-headings of your ‘materials & methods’ section (see similar papers, instructions for authors). Add your ‘hypothesis statement’ (from session 1) & ‘research design statement’ at the beginning of this template. List five strengths & weaknesses of your research design. © Eric J. Visser 2017 UNDA. All rights reserved

End © Eric J. Visser 2017 UNDA. All rights reserved