Research Proposal PDF

PART 1: RESEARCH PROPOSAL 249  Lecture (1): Writing Research Proposal Learning Objectives: Define a research proposal. Recognize the purpose of writing a research proposal. Outline the core components of the research proposal. Mention the...

PART 1: RESEARCH PROPOSAL 249  Lecture (1): Writing Research Proposal Learning Objectives: Define a research proposal. Recognize the purpose of writing a research proposal. Outline the core components of the research proposal. Mention the characteristics of effective titles. State the information that should be included in the statement of a problem. Formulate research aim, objectives, research questions and hypothesis. Identify types of variables in research. List the various components of the methods section in a research proposal. State what is meant by operationalization. Select the appropriate study design. Mention factors considered in selection of study population Name important documents that should be submitted to ethics committee for proposal approval. Mention components of informed consent forms. State data collection methods and tools. Describe components of data analysis plan. State what is meant by a pilot study. What its purpose. State what is meant by Gantt chart. Recognize what should be included in the budget plan. Mention the appropriate appendixes that should be included in the proposal. Introduction: Research is the systematic collection, analysis, and interpretation of data to answer a certain question or solve a problem. Research is a creative process. Research supplies answers to solve problems, so to get useful answers or outcomes, it is vital to ask the correct research question. 250 Steps of conducting health research: I- Selecting a research topic II- Review of literature for existing information III- Development of a research proposal IV- Implementation of study: Data collection Data management (processing and analysis) Interpretation of results Final report writing Presenting (Disseminating) the results: Scientific publication, presentation at meetings, seminars, workshops or conferences, and presentation for administrators and policymakers. Criteria for selection a research question or problem: FINER Feasible Interesting Novel Ethical Relevant Good research question or problem: Feasible o Subjects o Resources o Manageable o Data available? Interesting Novel o In relation to previous findings o Confirm or disprove? o New setting, new population Ethical o Social or scientific value o Safe 251  Relevant o Advance scientific knowledge? o Influence clinical practice? o Impact health policy? o Guide future research? What is research proposal? A research proposal is your PLAN. It describes in details your study. Approvals to proceed the study by the reviewers, Institutional Review Board and funding agency are based on the quality of the proposal. A research proposal is a detailed description of a proposed study designed to investigate a given problem. Every research study SHOULD HAVE a written research proposal. A well- developed research proposal is a critical first step for researchers needing to seek approval, support or funding. It is intended to convince others that you have a useful research project and that you have the competence and the work-plan to complete it. Regardless of the type of proposal, the area of research, or the methodology, all research proposals should describe: ▪ What you plan to accomplish? ▪ Why you want to do it? ▪ How are you going to do it? Questions that proposal answer: Question to be asked Steps to be taken What is the problem? The problem Statement of the problem Why should be studied? Rationale What information is already Literature available/existing? Unanswered review/background question 252 Why do conduct research? (What is the achievement of the research)? Formulation of aim and objectives How to carry out the research? Research methodology The process Who will carry out and when? Work plan How will be monitored? Research administration plan How the research findings will be used? The resources What and how much resources are Budget plan needed? Funding organizations Who will provide the resources? What is the purpose of a research proposal? States the research question to be answered Provides a detailed structured written working plan of the study before you begin Provides reviewers with a document for early reviewing prior to its completion (peer reviewing) Allows other research staff, whether at the same location or at other locations to carry out the study in exactly the same way. Acts as a guide for the research team of the initial project aims, procedures and researchers’ duties and responsibilities It provides the basis for funding and/or human research ethics applications. Gain permission to access participants or sources of data. CORE COMPONENTS OF A PROPOSAL 1. Title of the research 2. An introduction: problem statement, literature review 3. Objectives of the study/ Research questions or hypotheses to be tested 4. Variables 253  5. Methodology ▪ Study design ▪ Research subjects or participants ▪ Research setting ▪ Sampling design and sample size ▪ Ethical issues ▪ Data collection methods & instrument(s) ▪ Data analysis plan 6. Pilot study 7. Proposed time-frame for the project (Gantt chart) 8. Budget 9. References 10. Appendixes 1-TITLE The title summarizes the main idea of the study. An effective title not only prick’s the readers interest (catchy), but also predisposes him/her favorably towards the proposal. A good title contains the fewest possible words (concise) that adequately describe the contents (study variables) and/or purpose of the research paper. Characteristics of effective titles 1.Answers what, among whom, where and when 2.Avoid using abbreviations. 3.Interesting (reader gabber), catchy. 4.Include key variables (dependent and independent). 254  5.Predict the relationship between variables which supports the major hypothesis. 6.Titles are usually in the form of a phrase but can also be in the form of a question. 7.Limited to 10 to 15 basic words. 8. Use correct grammar and capitalization. ▪ Do not include "study of", "analysis of" or similar constructions. ▪ It is best NOT to write the title until you have finished writing the rest of the research proposal. Example of a title Impact of Fast-Food consumption on Health of Medical Students in Alexandria University, (academic year 2019-2020) 2. INTRODUCTION After the title, the introduction is the next to be read. It is an opportunity to show the readers why the research topic is worth to read about. It includes statement of the problem and review of literature What information should be included in the statement of the problem? 1.A concise description of the nature of the problem (the discrepancy between what is and what should be) 2.Time frame (is it currently problem=exists now) 3.Magnitude (size) (illustrative statistics, incidence, prevalence, severity of the problem) 4.Distribution: who (characteristics of population affected), where (geographic area) 5.Problem analysis? The major contributing factors that may cause the problem and its consequences. 255 6.State efforts done previously to solve the problem and their effects: What untried solutions might there be? 7.Unanswered questions/research gap in existing knowledge/debate/limitations: What parts of the problem need further research if the problem is to be fully understood? 8.A description of the type of information expected to result from the project, and how this information will be used to help in solving the problem. (Expected benefits/outcomes) 9.Rationale for your research (establish the need, the importance, the urgency, the necessity for this proposed study) Review of related literature (work done by others) It refers to reviewing of all sources of scientific evidence pertaining to the topic in interest Demonstrate& update your knowledge The common structure is usually chronological ie arranged by date to analyze the progression of something overtime Literature should include supporting data, disagreements and controversies. Avoid Plagiarism Reference immediately after mentioning Not end of paragraph ALWAYS identify source (in-text citation) Summarize useful points Paraphrasing 256 3. OBJECTIVES/RESEARCH QUESTIONS/HYPOTHESES Term Definition Research aim/ general A statement indicating the general purpose of a research. objective Usually, a research will have ONLY ONE broad aim Research objectives Specific statements indicating the key issues to be focused on in research. Usually, research will have several specific objectives Research questions An alternative or with to research objectives, where the key issues to be focused on in research are stated in the form of questions. Exploratory and descriptive studies may pose research questions. Research hypotheses A prediction of a relationship between two or more variables, usually predicting the effect of an independent variable on a dependent variable. The independent variable is the variable assumed to have causal influence on the outcome of interest, which is the dependent variable. Used in analytical research to test the hypothesis Formulation of aim and specific research objectives Objectives should be closely related to the statement of the problem. For example: The problem: delay in diagnosis of leprosy in country (X). The general objective: to determine factors that contribute to delay in diagnosis of leprosy in country (X) If we break down this general objective into smaller and logically connected parts, then we get specific objectives (problem analysis). 1.To identify patients-related factors of delay such as demographic variables, stigma, 257 traditional healers preference 2.To identify health care system related factors of delay health center funding, symptoms at presentation, number of symptoms, misdiagnosis and clinical examinations. 3.To determine the association between patient delay and selected patients and heath system factors N.B - Limit to only 3-5 specific objectives. How should you state your specific objective? (SMART Objective ) Specific (addressing one action/activity only) Measurable (can be evaluated, using action verb) Attainable (reasonable, given the resources available) Relevant (provide answer to research question) Time-bound (can be achieved in study period) o Objectives should be stated using “action verbs” that are specific enough to be measured: o e.g. To determine …, To assess, To establish, To compare…, To verify…, To calculate…, To describe…, To explore, To identify, To find out etc. o DO NOT USE vague non-action verbs such as: To appreciate …To study…… To understand… To believe 4. VARIABLES ▪ During the planning stage, it is necessary to identify the key variables of the study and their method of measurement and unit of measurement must be clearly indicated. 258 TWO types of variables are important in research: a. Independent variables: The different synonyms for the term ‘independent variable’ which are used in literature are: cause, input, predisposing factor, risk factor, determinant, antecedent, characteristic and attribute. b. Dependent variables: variables in which changes are results of the level or amount of the independent variable or variables. Synonyms: effect, outcome, consequence, result, condition, disease. ▪ The objective of research is usually to determine the effect of one or more independent variables on one or more dependent variables. For example: Research question: "Will alcohol intake (independent variable) have an effect on development of gastric ulcer among adolescents (dependent variable)"? ▪ Operational definition of different study variables should be clearly phrased. ▪ Operationalizing of variables means that you make them ‘measurable.’ ▪ It is important to determine the method of measurement and the unit of measurement. ▪ The same variable can be measured by different levels (nominal, ordinal, interval) Variable: participants were asked about level of knowledge in a specific issue (10 questions scored as 0=don't know, 1=know ▪ Nominal: Know, don’t know ▪ Ordinal: poor (0-3 correct answers), reasonable (4-6 correct answers), good (7-10 correct answers) ▪ Interval: total score of knowledge 5.METHODOLOGY ▪ The heart of the proposal ‘Where’, ‘Who’, “when” ‘How?’ ▪ The methodology section has to be thought out carefully and written in full detail. ▪ It is the most important part of the proposal. 259  ▪ The methodology should consider the study design and the techniques and procedures used to achieve the proposed objectives. Core components of methodology section A. Study design B. Research setting C. Research subjects or participants D. Sampling design and sample size E. Proposed intervention F. Ethical issues G. Data collection methods and instrument(s) H. Data analysis plan A. Study design ▪ The type of study design should be decided based on: The basis of its proposed objectives The availability of resources In addition to ethical considerations. ▪ The investigator should clearly state the type of study that will be conducted and provide a detailed explanation of selection. Purpose: to investigate the causes of disease and to establish links between risk factors and health outcomes. We have a lot of resources in term of manpower, time and money. All ethical issues will be followed in selection and designing the study................. Cohort study 260  Epidemiological study designs Experimental Observational (intervention studies studies) Descriptive Analytic studies Preventive trials studies Case control Therapeutic Ecological study Case report Surveys study (Clinical trials) Case series Cross sectionl Cohort study report study Figure 1: classification of epidemiological studies B. Research setting ▪ The location(s) of where the study will be conducted. ▪ You need to mention whether the study is going to be a single-site study (e.g a hospital) or a multi-sites study (i.e. conducted in more than one location eg. private, public sectors, rural, urban locals). C. Research subjects or participants ▪ The target/theoretical population is the entire group of people (or objects) you wish to generalize the study findings to. o For example: your theoretical population may be adolescents aged 18 years in the Northern Province. ▪ The study population is the entire collection of people that you will have access to. o The study population could be defined as all Grade 11 students registered at schools in the Northern Province. ▪ Sampling: the process of selecting a portion of the population to represent the entire population of interest (study population) 261 The following questions should be answered:.What are the criteria for inclusion or selection? Allow for participation demographic, clinical, and geographic characteristics. 1.What are the criteria for exclusion? Eligible individuals, disallow their participation Common exclusion criteria include lost to follow-up, miss scheduled appointments to collect data, provide inaccurate data, have comorbidities that could bias the results of the study, or increase their risk for adverse events 2.What is the sample size and sampling procedure you will use so as to ensure representativeness of the sample? Calculation of sample size has been made easy by computer software programs, but the principles underlying the estimation should be well understood. The prevalence of the major coronary diseases in adult males in the rural areas of the North Carolina. Inclusion criteria: 1.Adult male above 40 years of age 2.Definitely diagnosed with major heart diseases 3.Their geographical location should be rural areas of North Carolina. Exclusion criteria: 1.Individuals have other medical, or psychological conditions that can influence the results of the study 2.Those who are unable to read and complete a questionnaire (self-administered questionnaire) ▪ Students being absent on the day of data collection and/or unwillingness to participate from the start are not exclusion criteria and are accounted for by the non-response rate in the sample size calculation. 262 D. TYPES OF SAMPLING 1.Probability: each member in the population has an equal, independent chance of being selected. The goal is to obtain a sample representative of the target population. Examples: ∗Simple random sampling *Systematic random sample ∗Stratified random sampling ∗Cluster sampling 2.Non-probability: may differ in important ways from the target population because of how they were selected (selection bias). Examples: ∗Convenience sampling ∗Purposive/judgmental sampling *Quota sample * Snowball sample E. PROPOSED INTERVENTION ▪ In experimental research, the experimental treatment or manipulation should be described. ▪ The literature review: should have provided a justification for the use of this intervention, including information on dosing, expected benefits and the risk of side effects. ▪ In the methods section: how intervention should be described in terms of when and how it will be administered, dosing, etc. F. ETHICAL ISSUES ▪ Ethical considerations apply to all types of health research. 263  ▪ Before the proposal is submitted to the Ethics Committee for approval, two important documents must be developed and attached to the proposal. ▪ In additions, there is another vital issue of Conflict of Interest, wherein the researchers should furnish a statement regarding the same. First document: the informed consent form (informed decision – making) 1.It should be written in the subjects’ mother tongue and in simple language which can be easily understood by the subject. 2.The use of medical terminology should be avoided as far as possible. 3.It should explain why the study is being done and why the subject has been asked to participate. It should describe, in sequence, what will happen in the course of the study, giving enough detail for the subject to gain a clear idea of what to expect. 4.It should clarify whether or not the study procedures offer any benefits to the subject or to others, and explain the nature, likelihood and treatment of anticipated discomfort or adverse effects, including psychological and social risks, if any. 5.It should indicate that the subject has the right to withdraw from the study at any time without, in any way, affecting his/her further medical care. 6.It should assure the participant of confidentiality of the findings. Second document: Ethics checklist The proposal must describe the measures that will be undertaken to ensure that the proposed research is carried out in accordance with the World Medical Association Declaration of Helsinki on Ethical Principles for Medical research involving Human Subjects. It must answer the following questions: 1.Is the research design adequate to provide answers to the research question? It is unethical to expose subjects to research that will have no value. 2.Is the method of selection of research subjects justified? The use of vulnerable subjects as research participants needs special justification. 264  Vulnerable subjects include those in prison, minors and persons with mental disability. In international research it is important to mention that the population in which the study is conducted will benefit from any potential outcome of the research and the research is not being conducted solely for the benefit of some other population. 3.Are the interventions justified, in terms of risk/benefit ratio? Risks are not limited to physical harm. Psychological and social risks must also be considered. 4. For observations made, have measures been taken to ensure confidentiality? G. DATA COLLECTION METHODS AND INSTRUMENT(S) There are a variety of techniques and tools that can be used to collect data in a research study. Technique (method) of data collection: the means of gathering data with the use of specific tools e.g observation of selected behavior Tools for data collection: A research instrument that the researcher uses to collect the data e.g observation checklist Selection of method of data collection Nature of the research problem (sensitive issue X face to face interview) Purpose of the research study (to assess practices X administrating questionnaire) Type of the study design (survey X observation checklist) Literacy level of the study participants (illiterate X administrating written questionnaire) Size of the sample (small X administrating questionnaire) Time frame of the study (limited time X Interviewing) 265  Availability of resources and manpower (Lack of resources X Interviewing, observation) Types of data collection methods Data collection falls under two broad categories: qualitative and quantitative data collection methods. Qualitative Method Method: Unstructured interview(open- ended questions) Tool: Interview guide/opinionnaire The qualitative research methods of data collection DOES NOT involve the collection of data that involves numbers or a need to be gathered through a mathematical calculation, rather it is based on the nonquantifiable elements like the feelings, emotions, reactions, opinions, views of the study participants. Quantitative Method Method: Administering Questionnaire Tool: Questionnaire Quantitative methods are presented in numbers and require a mathematical calculation to deduce. H. DATA ANALYSIS PLAN Formulate your data analysis plan at the proposal stage, and include it in your research proposal. The description should include: The statistical software that will be used for data entry and analysis Plans for processing and coding the data The choice of the statistical method to be applied to each data. 266 Planned data analysis Dummy tables are useful for planning your analysis. Dummy tables do not contain any numbers. Dummy tables should address both descriptive and analytical components of the study, and should include tables/charts/graphs, cross tabulations for associations, including the tests to be used to assess statistical significance. 6. PILOT STUDY A small scale trail study carried out before the research design on a sample recruited from study population. You must collect data and analyze them as part of your pilot study. 267  The pilot study is extremely important because it enables you to make adjustments in both your study design and study instruments (improve quality of final study). 7.PROPOSED TIME-FRAME FOR THE PROJECT (GANTT CHART) A Gantt chart is a useful graphical tool which shows activities or tasks performed against time. You put weeks, days or months at one side, and the tasks at the other. The Gantt chart shows ✓ The specific activities for the study ✓ The point each activity should start ✓ The length of time allotted for each activity ✓ Any overlap of activities leading up to the end of the study. 268 8.BUDGET This should include a detailed costing of the study. All resources necessary to undertake the project research should be included, eg. salaries, travel, accommodation, equipment and other incidentals. Each specific cost for the research needs to be justified The budget has to relate directly to your timescale. It is pointless asking for funding for three months if your research is likely to last a year. It is also a good idea to include quotes from companies for any equipment that is needed. 9.REFERENCES The proposal should end with relevant references on the subject. References should be written in Vancouver style. For web based search include the date of access for the cited website For example: add the sentence "accessed on June 10, 2008". 269 10.APPENDIXES The following are the appropriate appendixes that should be included in the proposal. 1.Interview guide/ self designed questionnaire form 2.Sample of informed consent forms 3.Cover letters sent to appropriate stakeholders 4.official letters for permission to conduct research 5.Regarding original scales or questionnaires, if the instrument is copyrighted then permission in writing to reproduce the instrument from the copyright holder or proof of purchase of the instrument must be submitted. 270  Tutorial (1): Writing a research proposal Intended Learning Outcomes: By the end of the tutorial students will be able to: 1. Assess knowledge gained in the previous chapter 2. Describe the effective title of a research 3. Mention information that should be included in the introduction section. 4. Identify the two types of variables that are important in research 5. Mention factors considered in selection of the study design 6. Mention the contents of informed consent form 7. Mention methods of data collection and the instrument used for each 8. Mention the appropriate appendixes that may be included in the research proposal ❖ What is a research proposal? A research proposal is your PLAN. It describes in details your study. ▪ A research proposal is a detailed description of a proposed study designed to investigate a given problem. ▪ A well-developed research proposal is a critical first step for researchers needing to seek approval, support or funding. ▪ It is intended to convince others that you have a useful research project and that you have the competence and the work-plan to complete it. ❖ Questions that a proposal answer: ▪ Regardless of the type of proposal, the area of research, or the methodology, all research proposals should describe: ▪ What you plan to accomplish? ▪ Why you want to do it? ▪ How are you going to do it? 271  Question to be asked Steps to be taken What is the problem? The problem Statement of the problem Why should be studied? Rationale What information is already Literature review/background available/existing? Unanswered question Why do conduct research? Formulation of aim and (What is the achievement of the objectives research)? How to carry out the research? Research methodology The process Who will carry out and when? Work plan How will be monitored? Research administration plan How the research findings will be used? The resources What and how much resources are Budget plan needed? Funding organizations Who will provide the resources? CORE COMPONENTS OF A PROPOSAL 1. Title of the research 2. An introduction: problem statement, literature review 3. Objectives of the study/ Research questions or hypotheses to be tested 4. Variables 5. Methodology ▪ Study design ▪ Research subjects or participants ▪ Research setting ▪ Sampling design and sample size ▪ Ethical issues ▪ Data collection methods & instrument(s) 272  ▪ Data analysis plan 6. Pilot study 7. Proposed time-frame for the project (Gantt chart) 8. Budget 9. References 10. Appendixes What is the purpose of a research proposal? 1. States the research question to be answered. 2. Provides a detailed structured written working plan of the study before you begin. 3. Provides reviewers with a document for early reviewing prior to its completion (peer reviewing). 4. Acts as a guide for the research team of the initial project aims, procedures and researchers’ duties and responsibilities. 5. It provides the basis for funding and/or human research ethics applications. 1. Title Of The proposal It should: Answers what, Describe the purpose among whom, where of the research and when Avoid using Interesting (reader abbreviations. gabber), catchy. Include key variables Use correct grammar (dependent and and capitalization independent). 273 Title: “Prevalence and associated factors of depression among medical students in Alexandria University 2022” What do you think about the title? Q1: Is the title of the proposal effective? Items of criticism Yes No Answers what, who, where and when Describe the purpose of the research Avoid using abbreviations. Use words stimulate reader interest. Include key variables, both dependent and independent. Suggest a relationship between variables which supports the major hypothesis. Limited to 12 to 15 substantive words. Use correct grammar and capitalization. 2. Introduction Introduction should provide: 1. A concise description of the nature of the problem 2. Magnitude (size) 3. Distribution: who (characteristics of population affected), where (geographic area) 4. The major contributing factors that may cause the problem and its consequences. 5. Unanswered questions/research gap in existing knowledge/debate/limitations: 6. Rationale for your research (establish the need, the importance, the urgency, the necessity for this proposed study) 274  Prevalence and associated factors of depression among medical students in Alexandria University 2022 Introduction Depression is a common health problem among medical students and its burden is on the rise. 1, 2 The proportion of the global population with depression in 2015 was estimated by the World Health Organization (WHO) to be 4.4%. The WHO ranked depression as the single largest contributor to global disability (7.5% of all years lived with disability in 2015), with more than 80% of the disease burden occurred in low- and middle-income countries. In Egypt (2015), the prevalence of depression was estimated to be 3.5%. 1 High rates of depression were reported among medical students as compared to the general population. 3 In 2013, a systemic review reported that the prevalence rates of depression among medical students ranged from 10% to 85% with a weighted mean prevalence of 30.6%. 4 From 2009 to 2014, studies reported that the prevalence of depression among medical and university students in the UAE, Saudi Arabia and Oman ranged from 22.2% to 48.2%. 5–9 Several studies were conducted in Egypt. In 2010, Amr and El Gillany reported that 28.3% of medical students, from all six academic years, in Mansoura University had depressive symptomatology. 10 In Alexandria (2015), the prevalence of depression among first academic year medical and pharmaceutical students was reported to be 57.9% and 51.1%, respectively.11 Depression was detected in 60% of medical students in the 1st to 4th academic years as reported by a study carried out in Al-Fayoum (2017).12 In addition to the everyday stresses that contribute to the development of depression, medical students are more prone to depression than the general population due to the presence of additional academic, personal life, and social factors. Medical education is perceived as stressful due to academic demands, frequent exams, time pressure, too much work load in the form of big content and wide scope syllabus that needs to be covered, increased psychological pressure, getting behind in work and inability to cope.13–16 Other factors include stigma associated with poor academic performance, and pressures due to competitive nature of medical education in students with excellent academic performance.17 Also, some students might be moving away from family home, losing the adult supervision and the traditional social and financial support for the first time in their lives.18, 19 Depression has a massive impact on the student's quality of life. On the personal level, it causes college dropout, impaired ability to work efficiently, deterioration in relationships, substance abuse, attrition from the profession and increased suicidal tendency.20 Depression adversely affects patient care, relationship with the staff members and eventually the culture of the medical profession.20 Although the prevalence of depression among medical students was studied in Alexandria, Egypt 11 but the results related to the 1st year medical students were alarming and calling for further studies among the senior students. 6 275 Therefore, studying depression on medical students is vital to investigate the problem thoroughly and come up with important recommendations. Furthermore, the results of this study can aid in the planning and development of more effective intervention and prevention programs and in the implementation of more balanced medical curricula. This study will be conducted to estimate the prevalence of depression among Alexandria medical students and to identify the demographic, socio economic, academic, health status factors associated with depression among medical students in Alexandria. Q 2: state the problem. Q 3: Mention the criteria for selection of a research problem. 276 Q 4: Describe the magnitude of the problem. Q 5: What is the person distribution of the problem? (Who is more affected by the problem?) Q 6: Where does the problem occur? Q7: What is meant by literature review? 277 Q8: Analyze underlying causes of the problem. Q9: Mention the consequences of the problem? 278 Q 10: What parts of the problem need further research if the problem is to be fully understood? (Rationale/ research gap) Q 11: What type of information expected to result from the study, and how this information will be used to help in solving the problem? (Outcome) 3. OBJECTIVES/RESEARCH QUESTIONS/HYPOTHESES Term Definition Research questions An alternative or with to research objectives, where the key issues to be focused on in research are stated in the form of questions. Exploratory and descriptive studies may pose research questions. Research aim/ general A statement indicating the general purpose of a research. objective Usually, a research will have ONLY ONE broad aim Research specific Specific statements indicating the key issues to be focused on in objectives research. Usually a research will have several specific objectives 279 Q12: State the research questions. Q13: What are the differences between a general objective (Aim) and research specific objective? Q 14: What is the general objective of this study? 280 Q 15: State the specific objectives. Q 16: Apply SMART criteria on the stated objectives 281  4. Methodology Part (2): Methodology A cross-sectional study design will be used. The study will be conducted from May 2022 till August 2022. Study population will be medical students at the Faculty of Medicine, Alexandria University, Egypt. Inclusion criteria are students (both males and females), from the 4th, 5th and 6th academic years, and those who currently studying in Alexandria University for at least six months. Students on long leave (>1 month) due to health/personal issues and students whose admission has been cancelled and is no longer part of the regular batch were excluded from study. Students being absent on the day of data collection and/or unwillingness to participate are not exclusion criteria, and are accounted for by the non-response rate in the sample size calculation. The sample size was calculated using Epi-Info 7 based on a prevalence of depression among medical 11 students of 57.9%, and a confidence limit of 5%. The minimum required sample size at 95% confidence level was 374, and was rounded to 390. A 10% will added for non-response. A multistage stratified random sampling technique was used. Students were 1st classified according to their academic year. An equal number of students was selected from the 4th, 5th and 6th academic years (130 students from each year) with equal numbers of males and females (65 each). From each academic year, students were selected from the departments in which they were studying. Students of the 4 th academic year were selected from the Community medicine, ENT, and Ophthalmology Departments, and 6th year students were selected from Internal Medicine and General Surgery Departments. Students of 5th academic year were selected from Pediatrics Department only as students from the other Departments were having exams. Clinical rounds or practical sections were randomly selected and a systematic random sampling technique was used to select the students from these settings. A pilot testing self-administered structured questionnaire was used to collect the data. The Questionnaire consisted of socio-demographic, economic, social, and environmental variables. The tool was developed after an extensive review of the literature on the topic area. The 2nd was the Arabic version of the Beck Depression Inventory-2nd edition (BDI-II)21 which is a validated tool. The BDI-II is a screening tool used to assess the intensity of depressive symptoms. It consists of 21 items on a 4-point scale from 0 to 3. Scoring is achieved by adding the highest ratings for all 21 items. Scores of 0–13 indicate minimal depression, 14–19 indicate mild depression, 20–28 indicate moderate depression and 29–63 indicate severe depression. Data entry was performed using Statistical Package for the Social Sciences (SPSS) version 23, followed by processing and analysis. Categorical data were expressed as number and percentage, and quantitative data was presented by mean (X) and standard deviation (SD). Chi - square (X2) test was used for analysis of categorical data. Level of significance was set as p value