Clinical Research Project Design and Guidelines: Choosing a Research Ques8on

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1 Clinical Research Project Design and Guidelines: Choosing a Research Ques8on Odunayo M. Oluwatosin, FMCS (Nig) Department of Plas?c Surgery University College Hospital Ibadan 1

2 Learning outcome: by the end of this short talk, you should be able to: Describe the types of research embarked upon in the clinical sciences Discuss the stages of involvement in planning a research. Design a clinical research 2

3 Clinical Research Clinical research is a branch of medical science that determines the safety and effec?veness of treatment regimen including surgical procedures; appliances and diagnos?c mechanisms intended for humans. Pa?ent oriented involves studies: of mechanisms of human disease, of therapies of interven?ons for disease to develop new technology that is related to disease Epidemiological study to examine the distribu?on of disease and factors that affect health. 3

4 4

5 Study designs: Research in Clinical Science Non- experimental or Observa?onal Quasi- Experimental Experimental Basis for classifying study design subject manipula?on, randomiza?on and control 5

6 Research in Clinical Science Types of Observa?onal study Descriptive Study Analytical study Case report and case series Cross sectional study Cohort study Cross sectional study Retrospec2ve study Prospec2ve study 6

7 Research in Clinical Science Non- interven2onal study researcher describes and analyses researchable objects or situa?ons but does not intervene - exploratory research, descrip?ve research and compara?ve or analy?cal studies Interven2onal study researcher manipulates objects or situa?ons and measures the outcome - experimental studies and quasi- experimental studies. 7

8 Research in Clinical Science Types of Quasi- experimental study One- group pre- test, post- test Non equivalent control group design Case- control design Types of Experimental study Simple experimental design Randomized blocked experiment Cross- over design 8

9 Choose a research ques8on Brainstorm to get research topic ideas. Origin of research ques?ons: personal clinical experience recogni?on of gaps when engaged in audit or guideline development reading the literature, where a s?mula?ng editorial or a par?cularly arres?ng original paper immediately suggests further research involvement in policy development, when evalua?on of new services or methods of working becomes par?cularly important. Jones R. Choosing a research ques?on. Asia Pacific Family Medicine 2003; 2:

10 Choose a research ques8on Brainstorm to get research topic ideas. The first step in the research process is iden?fying a research problem which leads to brainstorming to get research topic ideas. Be specific and do not overgeneralize. The topic must be narrow and focused enough to be interes?ng, yet broad enough to obtain enough informa?on. hdp:// 10

11 Choose a research ques8on Read general background informa2on. hdp:// 11

12 Choose a research ques8on Focus in on your topic. Any topic will be difficult to research if it is too broad or too narrow. A great way to fine- tune a topic is to use the method tradi?onally used by newspaper reporters Who?- What?- Where?- When?- Why? Who is involved? What is the problem? Where is it happening? When is this happening? Why is it happening / Why is this a problem? hdp:// 12

13 Choose a research ques8on Iden2fy key concepts. This will assist in choice of keywords, conceptual framework and in literature search. Research Idea Concept 1 Concept 2 Concept 3 I want to know about body image. body image Is knowledge or percep8on of body image relevant to sa8sfac8on aher cosme8c surgery? To what extent do residents know that body image is relevant to sa8sfac8on aher cosme8c surgery? body image cosme8c surgery body image cosme8c surgery residents hdp:// 13

14 Choose a research ques8on Restate your topic as a focused research ques>on. Example: if your topic was in line with the foregoing, a possible research ques?on could be: Does the percep?on of body image influence the outcome of cosme?c surgery: a resident doctors perspec?ve at Ibadan 14

15 Choose a research ques8on Research and read more about your topic. hdp:// 15

16 Choose a research ques8on Formulate a thesis statement. Write your topic as a thesis statement. The thesis statement is usually one or two sentences that state precisely what will be proved, answered. The development of a thesis assumes there is sufficient evidence to support the thesis statement. The thesis statement or hypothesis will assist you in the decision on your method of sta>s>cal analysis hdp:// 16

17 Develop a Proposal The next thing aler formula?ng a ques?on is to develop a proposal which should consist of a good introduc?on or background to the study, jus?fica?on/significance of study as well as methods of sta?s?cal analysis. hdp:// 17

18 Consult partners Once a research idea has been developed, you should liaise with poten?al research partners. Discussing the research with poten?al partners will ensure that poten?al issues are iden?fied at an early stage. Where confiden?al informa?on may be exchanged with a poten?al partner, a confiden?ality agreement should be in place prior to discussing the study in detail with that poten?al partner. Once ini?al discussions are complete, you will need to formalize rela?onships via a contract. Contracts may only be signed by authorized signatories at the Hospital or University. 18

19 Algorithym for treatment of scalp and skull defects Direct closure No defect eg laceration Surgically created wound small defect Resuscitate patient Intact periosteum Large defect Defect No skull fracture No periosteal covering (bone exposure) Skull fracture Full thickness skin graft FLAP TRANSFER Split skin graft Primary replacement with rib, iliac bone and serratus anterior musculoperiosteal free flap Undisplaced Elevate fracture Depressed skull fracture No dural defect Bone loss Dural defect Defect less than 36cm 2 calp rotation flap ith direct closure of onor defect Defect less than 150cm 2 Large scalp rotation flap with skin graft Defect up to 175cm 2 Orticochea s three or four flap scalp transposition Possibility of distortion of hair line Galeal pericranial flap plus split skin graft Scalp Salvageable (not crushed) Total scalp loss Replantation (microvascular anastomosis) Temporal fascia or fascia lata graft Secondary Scalp not replacement wit salvageable split rib, iliac bone, acrylic Free latissimus dorsi muscle flap with skin graft 19

20 Pan African Congress on Cleft Lip and Palate, February

21 University of Ibadan/University of Connecticut Genetic Study of Keloid Group 21

22 Obtain ethical approval All Clinical studies require a favourable opinion from the Research Ethics Commidee. The Principal Inves?gator is responsible for obtaining ethics approval. The request for ethical approval should contain in addi?on to the ini?al proposal, a consent form that contains the following details: What is the purpose of this research study? Will I find out the results of this research study? How many other people do you think will par>cipate? Is par>cipa>on voluntary and how long will my par>cipa>on in this study last? What are the costs to me for par>cipa>ng in this study? What types of risk are involved if I choose to par>cipate? How will my personal informa>on be protected? What are the benefits of par>cipa>ng in this study? What happens to the sample if I withdraw from the study? 22

23 Fundability and publishability Contributors to fundability: Intellectual content as well as the presenta?on should be above average. The level of research interest in the topic must be aroused Research relevant to current clinical challenges and government policy. Contributors to publishability: Posi?ve answers to the who cares? test the so what? test. Clinically or policy- relevant, well- conducted research will usually find a home in the literature 23

24 CONCLUSION 24

25 CONCLUSION It is hoped that colleagues will be challenged to spend more?me on the bench and in the field to give us a clearer picture of what our prac?ce involves This will invariably translate to beder care. 25

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