 Hello all, welcome to my channel. In this video, I am going to explain about how to prepare a good research protocol. Writing a good research protocol is important for three things. Firstly, protocol preparation is mandatory to get institutional ethical committee clearance. Secondly, a well-written protocol will make you plan and execute your research study very well. Thirdly, protocol will help you in writing the paper. In fact, a well-written protocol is half-written scientific article. So, protocol preparation is exactly the first step in research where you want to address a problem in research which will make you discover a new idea which leads to gathering and analyzing of data, writing and publishing the article, sharing the research through various platforms and getting cited by other researchers and this research cycle continues. While selecting the topic, we should keep this acronym finer in our mind. That is, your research should be feasible, interesting, novel, ethical and relevant. Now, the preparation of research protocol includes two key components. One, a good thorough review of literature. Secondly, a well-written methodology. After the research protocol gets approved or modified, collection and entry of data should be done followed by data analysis followed by writing the research either in the form of thesis or scientific paper. This slide shows the anatomy of a scientific paper. In introduction, we answer three questions. That is, what is known, what is not known and what are all the gaps and how and why we should fill the gap. In methods, we answer one question that is what we have done. In results, we answer our research question. In discussion, we will make the results fill in the gap between known and unknown. In conclusion, we try to convey what does this study mean for us going forward. This style of writing a research paper is called as IMRAD style, IMRB, IMRAD, Introduction, Consisting of Need for the Study, Objectives and Review of Literature. M stands for methodology, R stands for results, D stands for discussion, which includes limitations and recommendations followed by conclusion, references and annexes if we need. In introduction, we need to introduce the general topic explaining the burden and impact of the problem. This will make us understand the importance of the topic and should create interest in the topic. We should follow a sequence while writing the paper as if we are telling a story. Through a thorough review of literature, we should explain what is known and what is unknown and what are the gaps. This will automatically lead to the justification or the need for the study. While writing introduction and review of literature, we should keep in mind two things, number one, plagiarism and number two, referencing. Plagiarism is using someone's idea, thoughts, language without proper citation. This happens as a result of the cut copy paste. It can be avoided by writing our own sentence and referencing others, ideas, thoughts and language. The second thing in introduction and review of literature is referencing. When we refer our site source, which may be a journal article, book, website, most commonly a journal article. Each university or journal has for a specific referencing type, most commonly Vancouver style. The difference between each style is the order of details, number of authors you mention and the punctuation marks between the details. If you prepare manually the references in one style and the journal wants in different style, your work will get complicated. To address this issue, you should use a reference manager. The most commonly used reference manager are Zotiro and Menly. Both are equally good, has its own advantages and disadvantages. You can choose anyone among these two reference managers. We now move on to objectives. If a good researcher or reviewer wants to read your protocol, out of all sections of the research, they choose objectives first. While writing objectives, we should keep these acronyms in mind. That is picket and smart. Picket P stands for population in which the study is done. I stands for intervention. C stands for the comparison group. O stands for the outcome we are expecting and T stands for the time. The objectives also should be smart. S stands for it should be specific, it should be measurable, it should be achievable, it should be relevant and also it should be time bound. With this, we are moving to the second half of the presentation methodology. Methodology comprises of these 10 headings, about each of them we will discuss in the coming slides. So, the number one on this list is study population. While knowing study population, we should understand what is target population, study population and sample. Suppose if we do a study on diabetic food in patients coming to our hospital, the target population will be all diabetic food patients, whom we want to generalize our findings. But the diabetic patients coming to our hospital will be study population, among them whom you are including in the study is called as sample. And the process by which you select your sample from the population is called as sampling. But the inference will be for the study population. There are various types of sampling methods. On the left is the probability sampling methods, where you give equal chance to each and every single person in the study population to be the part of the study. There are various types of probability sampling methods. Probability sampling methods are most commonly used in community based studies. In simple random sampling, sample will be selected from the list of population using random generated numbers from random table or computed generated numbers. In systematic random sampling, every nth number of the study population will be included in the study. In stratified random sampling, there will be a stratification with any factor, most commonly age and gender. In cluster sampling, groups among the study population will be included as a sample. On your right is the non-probability sampling methods. This will be the most commonly used method in hospital based studies. The most common method is convenience sampling. The convenience here will be any factor for convenience, most commonly time. Judgmental or purposive sampling is the one where the sample is selected for a particular purpose or a character. In quota sampling, we include certain number of the study population based on the certain characteristics. Snowball sampling is a type of non-probability sampling method, where the previous person identifies the next person from the study population to be included in the sample. This is most commonly used in stigmatic diseases like HIV and leprosy. The second component here is the sample size. While deciding the sample size, the researcher should be clear about their objective, study design, and should have a similar study or a reference study. Then sample size can be calculated using simple formula. Software and online websites also can help in this. If you are not able to calculate of your own, then you can ask for help always. Number 3 in methodology is the study setting. Basically, you need to explain where the study population is from and where the study is conducted. Next is the study period, which should mandatorily includes the data collection period, apart from other time period required before and after the data collection. You can use GAN charts to represent the timelines of research. Next on the list is study design. To name the study design correctly, we can use this algorithm. Start from here. Ask yourself whether you assign any intervention or not. If yes, it is an experimental study. You have to ask the next question whether the intervention is allocated randomly or not. If yes, it is a randomized control trial. If no, it is a non-randomized control trial. If you are not assigning any intervention, then that will be called as observational study. Then you should ask the next question whether you have a comparison group or not. If you don't have, then that is called as a descriptive study. If you have a comparison group, then that is called as analytical study. In analytical study, the next question is, what is the direction of exposure? If you start from exposure to outcome, then that is called as cohort study. If you start from outcome to exposure, then that is called as case control study. And if you are measuring exposure and outcome at the same time, then that is called as cross-sectional studies. Cross-sectional studies are otherwise called as prevalence studies. Next on the list is the most important thing, the ethics. Remember the committee which gives you approval to conduct the research is called institutional ethical committee. The four cardinal principles of ethics are autonomy, beneficence, non-maleficence, and justice. Autonomy is respecting the right of the participant. Beneficence is doing good for the participant. Non-maleficence is not harming the participants. Justice is doing the right thing or the fair thing. When submitting the research proposal, consent and patient information sheets are the two important annexures required for approval. The difference between the consent form and patient information sheet, consent form is for the researcher, patient information sheet is for the study participant. But the components are same. It should mention the main purpose of the study, procedures followed in data collection, potential risks associated with participation, potential benefits associated with participation, statements about protecting the confidentiality of the participants, and the participation is voluntary and the participants can withdraw at any time and it should include signature of the participant and researcher. Here is the example of the patient information sheet. Next on the list is inclusion and exclusion criteria. The rationale for inclusion criteria is that you include a participant who will yield better results for the study and can be defined easily. They should match better with the target population. In exclusion criteria, the participants with the factors which cause bias in results, patients with comorbidities, patients who have risk to participate in the study should be excluded. Remember bias should be excluded but not confounding factors. Confounding factors should be matched between the groups and should not be excluded. We should remember one more thing that the same variable should not be present in inclusion and exclusion criteria. You imagine a situation where gender is present in both inclusion and exclusion criteria which means you are including males in your study and from which we are going to exclude females from the study. So, the same variable should not be present in inclusion and exclusion criteria. Next on the list is the operational definitions and the study tool. Operational definitions should clearly define not only your disease of study but also the factors considered under the study. For example, if you are studying diabetes, you should define diabetes and also the factors associated with it like smoking, alcoholism, etc. Based on your study tool, your research will be categorized into primary and secondary research. Primary research includes surveys, polls, interviews, focus group discussions, observations. Secondary research includes online research, literature research and case study research. The last on this list is the statistical plan for the research. For any research, you have descriptive statistics and inferential statistics. In descriptive statistics, we describe the variables based on the type. That is, categorical variables will be summarized using tables with frequencies and percentage and visualized using pie charts or bar charts. Numerical variables are summarized using mean and standard deviation, visualized using histograms. In inferential statistics, if your study objective is estimation of parameters from the sample, by using confidence intervals, we try to estimate the true values present in the study population. If your objective is look for association between two factors, then we try to test the hypothesis wherein we apply statistical tests and we calculate p-value. If the p-value is less than 0.05, then we call the test results as statistically significant. To summarize, a well-written research protocol is half-written research paper. Research paper comprises of IMRAD, that is introduction, methodology, results and discussion. In methodology, we need to understand this 10 checklist. Thank you for watching this video. If you haven't subscribed to our channel, please subscribe. If you like this video, please click the like button and share the video. Thank you all.