INTRODUCTION TO CLINICAL RESEARCH FOR RESIDENTS

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Prepared by,Hani Tamim PhD, Associate Professor Department of Internal Medicine. Director Biostatistics Unit Clinical Research Institute. Director Fellowship and Residency Research Program. American University of Beirut Medical Center,Beirut Lebanon. Reviewed by,Haroutune Armenian MD DrPH,Professor in Residence at the UCLA. Professor Emeritus of Epidemiology at Johns Hopkins Bloomberg School of Public Health. Los Angeles USA,Mohammed Al Onazi MD, Consultant Pediatric Surgeon Department of Pediatric Surgery. Prince Sultan Military Medical City, Medical Education Consultant Saudi Commission for Health Specialties.
Riyadh Saudi Arabia,Saud Al Shanafey MD MSc MBA FRCSC. Deputy Executive Director Academic Training Affairs. Associate Professor Consultant Pediatric Surgeon,King Faisal Specialist Hospital Research Center. Medical Education Consultant Saudi Commission for Health Specialties. Riyadh Saudi Arabia,Edited formatted by,Vittoriana Crisera. Journal Manager Journal of Health Specialties,Saudi Commission for Health Specialties. Riyadh Saudi Arabia,Saudi Commission for Health Specialties 2014.
King Fahd National Library Cataloging in Publication Data. Saudi Commission for Health Specialties Riyadh 2014. Introduction to Clinical Research for Residents,92p 14 8cm 21cm. ISBN 978 9960 9832 9 5,1 Clinical medicine Diagnosis I Title. 616 075 dc 1435 9120,L D no 1435 9120,ISBN 978 9960 9832 9 5. Introduction to,Clinical Research,for Residents,Section 1 Overview of the research process 2. 1 What is research 2,2 Steps in conducting research 2.
Section 2 Formulating a research question 5,1 What is a research question 5. 2 Criteria of a good research question 5,3 Sources of research questions 5. 4 Elements of a research question 5,5 Criteria for a bad research question 6. 6 Example of a research question 6, Section 3 Conducting an effective literature review 7. 1 Definition of a literature review 7,2 The aim of a literature review 7.
3 Characteristics of a good literature review 7,4 Steps of a literature review 8. 5 Conclusion 14,Section 4 EndNote 15,1 What is EndNote 15. 2 Introduction to an EndNote library 16,3 To create a library 16. 4 Entering references into a library 16, 5 Inserting references and generating bibliographies in Microsoft Word 17. Section 5 Writing a proposal 19,1 Definition of a research proposal 19.
2 Aims of a research proposal 19,3 Sections of a research proposal 19. Section 6 Ethical issues and IRB 24,1 Ethical issues 24. Section 7 Data collection entry cleaning and management 27. 1 General terms 27,2 Data collection 28,3 Database structure 28. 4 Data entry 30,5 Data cleaning 31,6 Data management 32. Section 8 Descriptive statistics 33, 1 Descriptive statistics for categorical variables 33.
2 Descriptive statistics for continuous variables 35. Section 9 Inferential statistics 38,1 Definition 38. 2 Probability distributions 38,3 Types of inferential statistics 39. 4 General rule for normal distributions 41,5 Different statistical tests 41. 6 Sample size calculation 42,Section 10 Measures of effect 43. 1 Absolute risk 43,2 Relative risk 43,3 Risk difference 44.
Section 11 Overview of study designs 45,1 Observational studies 45. 2 Experimental studies 46,3 General terms 46,4 Biases in clinical research 48. Section 12 Cross sectional design 50,1 Definition 50. 2 Choosing a representative sample 51,3 Strengths and limitations 51. Section 13 Case control study designs 53,1 Definition 53.
2 Identifying cases 53,3 Identifying controls 54,4 Exposure assessment 54. 5 Matching 54,6 Analysis 55,7 Strengths and limitations 56. Section 14 Cohort design 57,1 Definition 57,2 Types of cohort studies 57. 3 Strengths and limitations 58,Section 15 Experimental studies 59. 1 Definition 59,2 Phases of clinical trials 59,3 Types of clinical trials 60.
4 Ethical consideration 60,5 Randomization 61,6 Blinding 61. 7 Analyses 62,8 Strengths and limitations 63,Section 16 Manuscript writing 65. 1 Overview 65,2 Manuscript preparation 65,3 Manuscript submission 68. 4 Submission response 69,Section 17 Evidence based medicine EBM 71. 1 What is EBM 71,2 Why we need EBM 71,3 EBM principles 72.
4 EBM steps 72,5 Limitations of EBM 74,6 Linking research to EBM 74. References 75,Appendices 79,I Research proposal 79. II Manuscript template 91, I would like to extend my gratitude to the Saudi Commission for Health. Specialties SCFHS and specifically Prof Dr Sulaiman Bin Omran Al Emran. the Deputy Secretary General of the SCFHS for his vision support and. guidance Moreover I would like to acknowledge Dr Mohammad Al Onazi. Medical Education and Postgraduate Training Department for his follow up. review and feedback, Moreover I would like to give special thanks to the team of Pragma RTS a. Research Training Services Company www pragma rts com for their support in. preparing this booklet specifically Dr Samaa Al Tabbah Their contribution was. at all the stages of the booklet preparation from the topic selection writing of. the different sections and final editing Their valuable guidance and advise was. much appreciated, Finally I would like to thank all those who provided their support in the.
preparation of this booklet specifically for editing proofreading and design. Hani Tamim PhD, Associate Professor Department of Internal Medicine. Director Biostatistics Unit Clinical Research Institute. Director Fellowship and Residency Research Program. American University of Beirut Medical Center,PO Box 11 0236 F15. Riad El Solh Beirut 1107 2020,Beirut Lebanon,E mail hani t hotmail com htamim aub edu lb. Section 1 Overview of the research process,Section 1 Overview of the research process. 1 What is research, Research is often viewed as the corner stone of scientific progress It is a.
systematic process based on scientific method that consists of testing hypotheses. careful observation and measurement systematic evaluation of data and. drawing valid conclusions 1, There are different research methods which are used in research all with specific. advantages and disadvantages Which one the scientist uses depends on the aims. of the study in addition to the nature of the phenomenon The main two types of. research designs used in medicine are the quantitative research design which. generates numerical data or information that can be converted into numbers. and the qualitative research design generates non numerical data that provides a. complete description of the research topic In this section we will focus on the. quantitative design 2,2 Steps in conducting research. The key steps of a research process start with a broad idea of the topic of interest. which is then focused on formulating a specific hypothesis or a question that. guides the following steps of data collection gathering interpretation and. analysis to reach a conclusion which can be generalized to clinical practice. The key steps in conducting research can be summarized as follows. a Identification of research problem It is the first statement made in any. research An example of a research problem which may be of a local concern. for the community is violence among children This is the problem to be. investigated At this stage the identified problem is still too broad in scope. Therefore the scope of the study needs to be narrowed down which can. only be done after a thorough literature review, b Carrying out a literature review A literature review is the process of. searching for information related to the research topic across multiple. databases and information resources reading evaluating and analyzing. them helps refine the topic and objectives of the overview to be written A. good literature review will help in finding gap s asking a good question. and accurately defining a problem as well as identifying a proper. methodology After doing a thorough literature review the focus can be. Section 1 Overview of the research process, narrowed down into violence among children who watch TV Programs. which needs parental guidance, c Formulating the research question research objective The next step in the.
research process after refining the objective through a thorough literature. review involves translating that research idea into an answerable question. A research question is the question that a researcher wishes to study or the. hypothesis he she wishes to test The most important part of the question is. to be researchable and answerable using established scientific methods and. procedures Otherwise the whole idea will have no point and will reach. nowhere Moreover the research question should attempt to fill a gap in. knowledge For example an answerable question could be Does watching. violent TV programs increase violence among children. d Proposal writing The main purpose of writing a research proposal is to. obtain ethical approval as well as funding A well written proposal provides. a structured outline guiding the researcher throughout each step of the. research process It is written to justify the postulated research question and. to present a detailed methodology in which the research should be best. conducted There is no universal format of the proposal Each institution. has their specific format, e Institutional Review Board IRB approval and ethical consideration IRB is. specific human subjects committees that review and determine the. ethicality of research IRBs exist in research institutions and consist of. academicians researchers clinicians and a representative from the. community The main task of the IRB is to protect the rights participants. in research being conducted IRBs have the authority to require. modifications on the proposal pertaining to all aspects of the research as. well as to disapprove a proposal Finally once the IRB grants the researcher. its approval he she can start conducting the research 1. f Data collection Data collection is the process of collecting the information. that will be used to answer the research question Its most important aspect. is to select the relevant information needed to answer the research question. The development of the data collection form is a time consuming process. and it should be given enough attention to ensure it is clear valid and. reliable It has to be piloted on a small sample of subjects to guarantee. applicability as well as identify any potential problems in the tool Finally. once the necessary fine tuning has been carried out data collection can be. done through surveys questionnaires interviews observations data. abstraction etc, g Data entry cleaning and management It is the process of entering the. information data into the computer There are many computer programs. Section 1 Overview of the research process, used for this purpose The most widely used is the Statistical Package for. Social Sciences SPSS Most of the time data entry is done manually After. finalizing data entry a data cleaning process is carried out to check for any. data errors or outliers Once data is clean data management starts which. includes creating new variables from the existing ones based on pre defined. h Data analyses Data analysis is the process of analyzing data using. statistical techniques in order to draw conclusions that support or reject the. hypothesis or answer the research question If the data were properly. entered cleaned and managed then the data analyses process should run. i Research dissemination Data analyses results should be organized into. tables and figures which serves multiple purposes such as understanding the. results identifying missing analyses comparing easily with other published. articles and preparing results for presentation Publishing the research. project is the final step of the research process which entails summarizing. the whole research findings in different forms such as an abstract. presentation report or a manuscript published in a journal 1 3 4. Section 2 Formulating a research question,Section 2 Formulating a research question. 1 What is a research question, A research question is a concise question which expresses what the research.
project aims to address it is the question the researcher wishes to answer The. first step in any research project is to clearly define the research question since it. will be the basis for developing and conducting the research project 5. 2 Criteria of a good research question, There are different criteria that define a good research question The best. research question is one that attempts to fill a knowledge gap in the literature. enough to be answerable and researchable should be relevant to the study s. objective should avoid duplication of previous work should be feasible and cost. effective and should be doable within a specified time frame allocated for the. research project Moreover it needs to meet the minimum ethical standards 6. 3 Sources of research questions, The researcher formulates a research question through different means. Literature reading might help a researcher identify the areas that need further. study and thus a hint towards a research question Another method is patients. observation through clinical experience which might pose different researchable. Introduction to Clinical Research for Residents 92p 14 8cm 21cm ISBN 978 9960 9832 9 5 1 Clinical medicine Diagnosis I Title 616 075 dc 1435 9120 L D no 1435 9120 ISBN 978 9960 9832 9 5 Introduction to Clinical Research for Residents Contents iii Preface 1 Section 1 Overview of the research process 2 1 What is research 2 2 Steps in conducting research 2 Section 2

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