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Clinical research ( intro and research question)

M
Mohamed Fahmy Dehim

This document provides an overview of the clinical research process. It discusses what research is, the purposes of research, and the typical steps involved. These steps include prioritizing a research topic, reviewing existing literature, developing a proposal, obtaining approval, collecting and analyzing data, writing reports, and presenting results. The document also covers generating research questions using techniques like critical thinking and observation. It introduces frameworks for formulating good research questions, including PICO/PECO for structuring questions and FINER for testing question feasibility. Finally, it discusses formulating hypotheses for the research.

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1 Clinical Research Basics Mohamed Fahmy Doheim M.B.B.Ch Candidate
Science Vs. Pseudoscience!
What is research? Systematic investigation to establish facts or principles or to collect information on a subject. Research is the systematic collection, analysis and interpretation of data to answer a certain question or solve a problem.
Research, why?
Citable documents in Medicine
Purposes of research Exploration Description Explanation
7 What are the Steps? Prioritizing and selecting a research topic (Idea, question) Review of literature and other existing information Development of a research proposal Getting formal institutional approval Data collection (field work) Data processing and analysis Final report writing Presenting the results in Scientific publications, presentation at meetingsetc.
8 What are the Steps? Prioritizing and selecting a research topic (Idea, question) Review of literature and other existing information Development of a research proposal Getting formal institutional approval Data collection (field work) Data processing and analysis Final report writing Presenting the results in Scientific publications, presentation at meetingsetc.
Topics of the series Research question or idea: generating and formulating Medical literature : What, where and how? Study designs and pyramid of evidence. Medical statistics How to read a paper? How to write a paper? Publication process
!Lets start Formulation of Research Question
Our Aim Good Idea Answerable research question
Research idea Research idea provides the very basic foundation of research work Good idea ---- good research
1- Picking up the research idea A) Reading literature B) Clinical practice and observation
A) Reading literature: When we read the literature, we usually will find some gaps and questions that need to be answered and some results that need to be confirmed. That's usually will come from the discussion part and the "recommendations" which the authors have proposed for further research. Here, the most important thing u will need is caring reading and critical thinking to generate your question.
Critical thinking 17+18 (is/are) 26? IS or ARE?
B) Clinical practice and observation: During clinical practice, you may find a case or cases admitted with some manifestations and passed many stages to reach the diagnosis and u may report as it is not classical (Case report or series). Moreover, you may observe something and generate and test your hypothesis (Finding a correlation)
Useful Techniques Rational thinking Creative thinking Searching the literature Scanning the media Brainstorming Exploring past projects Discussion Keeping an ideas notebook
Ranking of research topics Rating Sheet For Group Work Total Criteria for selection of research topic Proposed topic Ethical acceptability Urgency of data needed ApplicabilityPolitical acceptability FeasibilityAvoidance of duplication Relevance 1. 2. 3. 4. 5. Rating scale: 1 = low, 2 = medium, 3 = high.
2-Formulating your question PICO Principle
PICO Population, Patient, Problem P Intervention or Indicator I Comparator or Control C Outcome O
PECO Population, Patient, Problem P Exposure E Comparator or Control C Outcome O
PICO Example In mild to moderate adult asthmatics (P), does the regular use of salbutamol (I) compared to as needed use (C) result in worse asthma control (O)
Testing your question FINER method
FINER Feasible: adequate subject, expertise, affordable Interesting: to the investigator Novel: confirm, extend or refute previous findings and provide new findings Ethical: fulfill guidelines for the protection Relevant: to scientific knowledge
Broad or narrow? Research question could be broad, intermediate or narrow question: Broad: Efficacy of treatments of spinal muscular atrophy. Intermediate: Efficacy of VPA for spinal muscular atrophy. Narrow: Efficacy of VPA for spinal muscular atrophy type 2.
Formulating a hypothesis Adopted by the researcher is referred to as (Alternative Hypothesis; H1) The opposite event is referred to as (Null hypothesis; H0). Directional or not?
Clinical research ( intro and research question)

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Clinical research ( intro and research question)

  • 1. 1 Clinical Research Basics Mohamed Fahmy Doheim M.B.B.Ch Candidate
  • 3. What is research? Systematic investigation to establish facts or principles or to collect information on a subject. Research is the systematic collection, analysis and interpretation of data to answer a certain question or solve a problem.
  • 6. Purposes of research Exploration Description Explanation
  • 7. 7 What are the Steps? Prioritizing and selecting a research topic (Idea, question) Review of literature and other existing information Development of a research proposal Getting formal institutional approval Data collection (field work) Data processing and analysis Final report writing Presenting the results in Scientific publications, presentation at meetingsetc.
  • 8. 8 What are the Steps? Prioritizing and selecting a research topic (Idea, question) Review of literature and other existing information Development of a research proposal Getting formal institutional approval Data collection (field work) Data processing and analysis Final report writing Presenting the results in Scientific publications, presentation at meetingsetc.
  • 9. Topics of the series Research question or idea: generating and formulating Medical literature : What, where and how? Study designs and pyramid of evidence. Medical statistics How to read a paper? How to write a paper? Publication process
  • 11. Our Aim Good Idea Answerable research question
  • 12. Research idea Research idea provides the very basic foundation of research work Good idea ---- good research
  • 13. 1- Picking up the research idea A) Reading literature B) Clinical practice and observation
  • 14. A) Reading literature: When we read the literature, we usually will find some gaps and questions that need to be answered and some results that need to be confirmed. That's usually will come from the discussion part and the "recommendations" which the authors have proposed for further research. Here, the most important thing u will need is caring reading and critical thinking to generate your question.
  • 16. B) Clinical practice and observation: During clinical practice, you may find a case or cases admitted with some manifestations and passed many stages to reach the diagnosis and u may report as it is not classical (Case report or series). Moreover, you may observe something and generate and test your hypothesis (Finding a correlation)
  • 17. Useful Techniques Rational thinking Creative thinking Searching the literature Scanning the media Brainstorming Exploring past projects Discussion Keeping an ideas notebook
  • 18. Ranking of research topics Rating Sheet For Group Work Total Criteria for selection of research topic Proposed topic Ethical acceptability Urgency of data needed ApplicabilityPolitical acceptability FeasibilityAvoidance of duplication Relevance 1. 2. 3. 4. 5. Rating scale: 1 = low, 2 = medium, 3 = high.
  • 20. PICO Population, Patient, Problem P Intervention or Indicator I Comparator or Control C Outcome O
  • 21. PECO Population, Patient, Problem P Exposure E Comparator or Control C Outcome O
  • 22. PICO Example In mild to moderate adult asthmatics (P), does the regular use of salbutamol (I) compared to as needed use (C) result in worse asthma control (O)
  • 24. FINER Feasible: adequate subject, expertise, affordable Interesting: to the investigator Novel: confirm, extend or refute previous findings and provide new findings Ethical: fulfill guidelines for the protection Relevant: to scientific knowledge
  • 25. Broad or narrow? Research question could be broad, intermediate or narrow question: Broad: Efficacy of treatments of spinal muscular atrophy. Intermediate: Efficacy of VPA for spinal muscular atrophy. Narrow: Efficacy of VPA for spinal muscular atrophy type 2.
  • 26. Formulating a hypothesis Adopted by the researcher is referred to as (Alternative Hypothesis; H1) The opposite event is referred to as (Null hypothesis; H0). Directional or not?