Study Protocol

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Preparing Study Protocol : 

Preparing Study Protocol Lecture Notes Santoso Cornain MD, DSc Faculty of Medicine, University of Indonesia

Old SayingOld Saying : 

Old SayingOld Saying What people hear, they forget What people hear, they forget What people see, they remember What people see, they remember What people do, they learn What people do, they learn If you emphasize everything, you emphasize nothing If you emphasize everything, you emphasize nothing

The Elements of Science : 

The Elements of Science Creation of science as a process, consisting of / acc. to 5 elements of science : A. Identification of problem  Scientific problem  Evaluation/accounts for available information B. Formulation of Hypothesis C. Planning / designing & performing the investigation (research) to test the hypothesis D. Evaluation of results & drawing the conclusion E. Summarizing the whole process in an official form (report)

Hypothesis testing: Classical approach : 

Hypothesis testing: Classical approach According to 5 Elements of Science 1. Identification of sc. problem 2. Formulation of Hypothesis Research / Experimentaion 4. Analysis / Evaluation Summing up & Report writing

Preparing STUDY PROTOCOL : 

Preparing STUDY PROTOCOL Title Statement of Problem Objective of study Methods A. Design: sample size, Selection eligibility, sequence of procedure, Inherent problems B. Procedures: Laboratory or clinical study, Epidemiological study C. Data collection procedures Proposed statistical techniques

Starting Research Process : 

Starting Research Process Planning the Project Literature Review Project proposal Operationalize Research question Org’l access Design study

Slide 7: 

Ad 1. Title: - short and descriptive; - reflects the hypothesis; - no general inference beyond the scope of the study; Ad 2. Statement of problem: - introduced by background of the work of others leading to the idea for the present investigation; - state the identification of scientific problem including related variables to be analyzed; Ad 3. Objectives of the study: - formulate the hypothesis (es) to be tested; - focus the study on restricted, one or two, objectives.

Ad 4. Methods : 

Ad 4. Methods A. Design: Describe the planning and organization of the study investigation, with the outline of the approaches to analyze the problem and its related variables. Clarify the following items: sample size: small enough to complete work, large enough to detect differences; selection eligibility: details of criteria for inclusion and exclusion of subjects; sequence of procedures: time schedule and order of each part; inherent problems: - any inherent problems that may effect the design; - reasons for choosing the method rather than the different one.

Research process (con’d) : 

Research process (con’d) Org’l access Design study Obtain sample Select methods Collect data Analyze data Reporting & Presentation of Findings

Ad 4. Methods : 

Ad 4. Methods B. Procedures: Laboratory or clinical study dosage, route of administration; devices for reasoning responses: analytic procedures criteria for classifying patients: specific ranges for laboratory results for classifying stage of disease or group; Epidemiological study description of instruments for collection of information (questionnaire or interview form); description of dimension of instruments; C. Data collection procedures Forms for recording data: easy to use and to obtain information; 2. Data entry and data processing / EDP

Ad 5. Proposed statistical techniques: : 

Ad 5. Proposed statistical techniques: A. Preliminary tables and graphs of expected results: to insure that the questions are answerable by information collected B. Specific statistical methods: - tentative data analyzes, selected statistical procedures.

Criteria of research report (Master’s degree) : 

Criteria of research report (Master’s degree) Evidence of an original investigation or the testing ideas Competence in independent work or experimentation An understanding of appropriate techniques Ability to make critical use of published work and source materials Appreciation of the relationship of the special theme to the wider field of knowledge Worthy, in part, of publication

Reporting research findings : 

Reporting research findings Reporting to academic audience: * Academic format Writing up for academic publication: * Manuscript for publication * Thesis writing The client report: * Feedback to institution, grant agency etc. * Executive summary 4. Presenting of research findings: * Academic, scientific forum * Institutional, grant agency

Research Project (Progress) Report : 

Research Project (Progress) Report Research title Abstract (100-150 words) List of contents List of symbols and abbreviation List of figures and tables 1. Introduction * Survey of prior research * Background and objectives 2. Questions and hypotheses 3. Methods * Description of research design * Sample and organizational details * Materials and measures * Procedure 4. Results * Analysis * Significant findings 5. Discussion * Description of important / highlighted results * Interpretation / explanation * Limitations of study * Implications of study * Further research 6. Summary and conclusion 7. References 8. Appendices

The client report : 

The client report Executive summary ( 1 page ) Background to the research ( 1 page ) Method and procedure ( 1 page ) Results ( 5 pages maximum ) Interpretation / practical significance ( 1 page ) Recommendations ( 1 page ) References

Executive summary : 

Executive summary Spell out what was done How it was done When it was done Who and how many were involved What was found What the implications are of what was found What is recommended

Presenting research findings : 

Presenting research findings Prepare the format: 1). Introduction, 2). Development, 3). Consolidation / conclusion; Produce the content: 1) What will they need to know ?, 2). What will they need to do ?, 3). What do I need to demonstrate ?. Standard presentation format * e.g. use Power Point style

Presenting research findings (con’d) : 

Presenting research findings (con’d) Use Visual aids to provide: * structure, outline, ‘signposts’; * simplified explanation, clarified inter-relationships; * illustration of a point; * explanation of unfamiliar / complex ideas; * change of pace; * lasting impression. Appropriate use of visual aids: * CLEAR, * MEMORABLE, * LEGIBLE, * TO THE POINT.

Criteria of research report (Doctoral degree) : 

Criteria of research report (Doctoral degree) Evidence of an original investigation or the testing ideas Competence in independent work or experimentation An understanding of appropriate techniques Ability to make critical use of published work and sources materials Appreciation of the relationship of the special theme to the wider field of knowledge Worthy, in part, of publication Originality as shown by the topic researched or the methodology employed Distinct contribution to knowledge

Applying for Research Grant : 

Applying for Research Grant Proposal writing Answer Questions: Why do I want to do this? The Need What do I want to do? The Plan How am I going to do it? The Method What do I need? The Resources (Calman, 1976) Application is studied for several respects: Is the idea important ? Can it be done ? Is the applicant competent to do the work ? Can it be done with the specified time ? Are the costs realistic ?

Writing Research Proposal : 

Writing Research Proposal Title Introduction Material & Methods Facilities available The site of activities Finances needed Reference

Reasons for an application being rejected : 

Reasons for an application being rejected Scientific merit of the idea is not worthwhile; Applicant has not taken sufficient trouble to plan or think about the project; Too much reliance is being placed on others to do most of the work; Too much money is being asked for.

References : 

References Hawkins C, Sorgi M (Ed). Research: How to plan, speak and write about it. Narosa Publ. House, Toppan Co. Pte. Ltd. Singapore,1992. Sharp JA, Howard K. The Management of a Student Research Project. 2nd ed. Gower Publ. Ltd., England, 1996. Brewerton P, Milward L. Organizational Research Methods. Sage Publ., London, 2001. Levine RJ. Ethics and Regulation of Clinical Research. 2nd Ed. Yale Univ. Press, London, 1986. The Nuremberg Code: Permissible Medical Experiments. Gov. Printing Office, Washington DC, 1949, pp.181-2. World Medical Association Declaration of Helsinki: Recommendations Guiding Medical Doctors in Biomedical Research Involving Human Subjects. 18th World Medical Assembly, Helsinki, 1964 and revised by 29th World Medical Assembly, Tokyo, 1975.