Ya3teekom 2l 3afye, menra77eb fiku marra 2o5ra and first of all I am VERYY happy to see you again and

to have the honor to teach you this course in your third year (its an honor for us dr.), I was happy to teach you three of the most important courses that are needed basically for each dentist student; oral histology, dental anatomy and oral physiology. Congratulation for those how could pass the second year and are now studying in the third year, I will teach you another course which has a different topic, it is related to create from you a Researcher and this course is called Research Methodology or Research Design in this curse we will teach you how to have the ability or how to handle the basic principles of research methodology, because we dont want you just to practice dentistry we also want these dentist to do researches, and it is because of research that developing takes place, without research, believe it or not, the dentistry profession will stop at some stages! As a university lecturer, I am not only a lecturer, I am also a researcher, but unfortunately a lecturer in the developing countries like Jordan are more lecturers than researchers, but in fact if you go to any lecturer in any western country, you will find that this lecturer is also to fifty percent a researcher, but we are trying our best to do researches.

I am doing now a number of researches, and actually we are achieving big success in researches, the biggest success of my researches was while I was teaching you, it was about the Chronology of tooth eruption, so last year we studied the timing of tooth eruption according to studies found in Europe and America but we didnt have any studies done in Jordan so I did the first one, this will be available soon inshalla, so those who are now in the second year will learn the chronology of eruption according to the Jordanian population.

Slide (2): Research fields in medicine

In medicine we have different sciences; we have biological sciences, clinical sciences, population sciences, and health service sciences Biological sciences: like anatomy and physiology and etc Those sciences, which are related to diseases, focus on the basic knowledge and information in a specific field, for example when I tough you dental anatomy I was providing you every information that you need to know about the shape of the teeth. And you will learn the information about how a disease occurs in the field of oral pathology; these are examples of biological science.

Clinical sciences: is when you start to apply the information that we toughed you in the clinics. For example the science of making a filling (restorative dentistry) or

the science of treating an inflamed gingiva (periodontics) are clinical sciences, they will serve individual patients and you are trying to benefit that particular patient. Among the clinical science is what we call clinical epidemiology; epidemiology, in general, is the study of disease occurring in human population, for example AIDS, H1N1, gingivitisetc, IF the disease that I am studying will serve individual patients it will be called clinical epidemiology. Health services: it is the Study of how nonbiological factors affect the patients health. An example of non-biological factors is the lack of health services, for example if an ambulance needs two hours to take a patient and bring him to the hospital the patient may die. So studying the effect of the lack of services on the health of the patient is called health services science.

Slide (3): Clinical epidemiology

Clinical epidemiology: It is the science of making predictions about individual patients; we want to study the progress of a disease in an individual patient.

It is done by counting clinical events of similar patients; for example I will examine people having gingivitis and I will study the clinical events, and I will try to count these events by using strong scientific methods, so I cant just study and give estimation and thats it! After collecting data from the people I am examining, I have to build good analysis and good statistics which are based on
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scientific methodology, it cannot be done haphazardly! Because the information that this research give, will benefit the individual patient, we do that because we want to ensure that the predictions are accurate. So depending on the information provided by this examination we can predict what will happen for another patient suffering from the same disease, so if we are treating another group of patients with gingivitis, we can predict that they will be healthy for example in three month of treatment. For any field to be considered as clinical science, the final outcomes have to be applied to individual patience.

Slide (4): Purpose of clinical epidemiology

Purpose of clinical epidemiology is to:

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Develop and apply methods of clinical observation that will lead to valid conclusions, by avoiding being misled by systematic error and the play of chance. All the time as any researcher you have enemies, the enemy of any researcher is the error and chance, we dont want the chance and the systematic error to play a role in our analysis of data, all the time we try to minimize the role of them as much as possible, and eliminating them will be the best, by avoiding this you will get true results.

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To obtain the kind of information that the clinicians need to make good decision in the care of patients. After doing a research on the treatment of gingivitis we could say that people suffering from gingivitis will be healthy after three month of treatment, this piece of information is important, it is a conclusion that will be used by another dentist working by another place, because he will know that in a previous research that people undergoing gingival treatment will become healthy in three month, so he will try to apply this conclusion on his patient. So clinical epidemiology is important for helping the clinicians in making good decisions in the care of their patients.

Example

Slide (5): Clinical epidemiology

Why is clinical epidemiology clinical? Because it answers clinical questions, and it guides clinicians for making decisions.

Slide (6): Evidence-based medicine

Evidence-based medicine: is a term that we use when we apply clinical epidemiology to the care of the patient. Evidence-based means that we need to have evidence, we cannot build a conclusion without evidence.
Example

It has been already proved that smoking is the cause of lung cancer, we cannot say that just because we note that people who smoke have lung cancer, they may have lung cancer because of another cause, so we took samples and we tried to isolate all the other factors and we studied the effect of smoking particularly in the effect of lung cancer, and we proved by strong methodological evidence that smoking causes lung cancer, so it has to be evidence based, you cannot provide a conclusion of a research without an evidence.

Slide (7): Basic principles

The basic principles of any clinical research include first of all the (1) clinical questions, you have to ask a question before you start any research, and then you have to identify the (2) variables.
Example

In my research The chronology of tooth eruption in Jordanian population the question that was needed is Do we need to know the timing of eruption in the Jordanian population? and the answer was YES,
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because we dont have any data for the eruption in the Jordanian population, the variables that we have are for example the age, because we will examine people belonging to different ages, gender is another example because we will examine females and males, we may want to target for example the private schools only, this is a variable too, so we have generally two types of variable, dependent and independent, I dont want to discuss the difference between these two now, but it will be covered in one of the coming lectures 2nshalla .

Now after the question and identifying the variables you will see the (3) outcomes of the research, are the outcomes important? Are you doing a significant research?
Example

Is it important to know who is taller, the males or females?? No, because we already know that males are taller than females (HE3 :P), so any research about this topic is not important! It doesnt need all this amount of money and all that effort to do, so this is a stupid research and has no outcomes on the health at all. But in my research (the timing of eruption) does it have any health outcomes? For example if a patient comes to you and say my son is one year old and no teeth came out till now! When I referred to the European data we discovered that this is abnormal, but referring to the Jordanian data this was normal, so by knowing your data in specific, you will check if the child is having a problem or not, so this is a significant research.
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Then we have to look at the (4) numbers that we have in the research, and the probabilities, we will discuss this soon.

Slide (8): Clinical question

Each research has at least one question, what question can be asked?

Is the patient sick or well, is he abnormal or normal?

How accurate are tests used to diagnose disease (diagnosis) How often does a disease occur (frequency) What factors are associated with an increased risk of disease (risk) What are the consequences of having a disease (prognosis) How does treatment change the course of disease (treatment) Does an intervention on well people keep disease from arising (prevention)
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 What lead to disease (cause) To make this clear, I am now supervising master students, when the master student finishes his theses, I need to read and discover the research question, if I found that this is without a clear research question, the work will be rejected!

Slide (9): Health outcomes

Here we will see the effect of a research, or the events that can be studied, and it include Disease, Discomfort, Dissatisfaction, Disability, Death, these are the five Ds that are considered as the health outcomes that can be studied, it can only be studied on intact human; we cannot study this on human parts! For example we cannot see the disability in a dead patient which is already in pieces!!! Slide (10): Numbers and probability

Clinical science depends on quantitative measures, all the time try, if possible, to get numbers, because numbers are more accurate.

Example

If your marks were in the A, B, C system, there may be a student which get the top of the A+ and another student which get the bottom of the A+, but both will be A+, therefore numbers will be more accurate, because if I give a student 95 he will be better than another student with the mark of 92.
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So in clinical research we depend on quantitative methods, now Impressions, instincts and beliefs are also important but only when they are added to solid grounds of numerical information.
Example

If I want to study the severity of pain in some patient, I can ask: how do you feel? Is it severe or mild? But a better approach is when I ask him: Can you give me a number between zero and ten describing your pain? Zero means no pain, 10 means maximum pain. So a quantitative approach is much better than qualitative. This allows for better confirmation and estimation of error, when your research is based on numbers, it is very easy to apply this number to certain equations and to calculate or estimate the error. Prediction of treatment outcomes or disease sequence, for example a patient having lever cancer, this patient is interested in knowing the prognosis, and the chance of surviving, so we say to this patient your chance to survive is 10 percent, we are converting the qualitative measures into quantities, it is always good to give numbers in the treatment outcomes, so it is all the time better to be expressed as percentages.

Probability needs to be expressed quantitatively, Estimated by referring to past experience with groups of similar patients.

How could we know if a patient with a liver cancer will have 10 percent survival rate? because somebody else
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did a study on people suffering from liver cancers, isolating all the others factors, and then he notes that 90 percent of these people died, we built the probability on a clinical study done previously, thats why we need researches to help us in treating our patients.

Slide (11): Population and samples

Population: All people in a defined setting with certain defined characteristics. for example if we want to study the Jordanian population without any specific characteristics we say the Jordanian population, it includes anybody who live in the Jordanian population, but lets say I dont want to study only the Jordanian population, I want to study a specific population, I want to study those Jordanians who are living in irbeT (:P), so this is a specific population so you have to define the settings, if you dont define it, this may mean the whole population of the universe!

Examples are general population (all the population) or hospitalized population (people in a hospital), or if I want to study those who have a clicky TMJ, this is a population with a specific disease or observation.

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Slide (12): Population and samples

Sample: Is a subset of people in the defined population, not the whole population, it is not practical to test all the population. In my research, the ideal situation was to examine all the Jordanians whose teeth are in the erupting process, but can I study three million people!!! Impossible, so I selected a sample from this population and this sample needs to be represented in the research. Selection should not be haphazard; it has to be based on scientific method, thats why clinical research is all the time carried out on samples. The samples make inference about the population So when we study the sample, the conclusion that we get from that sample can be applied to that population, and in my research (the chronology of eruption) I studied all the schools in Jordan, HOW? I selected randomly fife schools from Irbed, Zarqa, Ammanetc, so I select certain number of schools, and then for each school I dont examine the whole school, I took three students from each class, so this is a sample, and a sample has to be randomized and has to be represented, so a good research is the one whose sample is 100 percent representative of the population.

Slide (13): Population and samples Two important points in selecting the sample (1) Are the conclusions of the research correct for the people in the
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sample?? This is important, first of all the conclusions that I have, have to be correct for that sample, now if actually the results are correct for that sample then I ask the second question(2)Does the sample represent fairly the population of interest? If yes, then the conclusion of that sample will be the same as the conclusion of the whole population. Slide (14): A sample is representative A sample is representative: that Depends on how a sample was selected, if I for example selected just people in Irbed, I cannot say that this represent the whole population, because the sample was not properly selected, there should be equal chance for all members to be selected. Computerized programs now are available for giving you the principles of how to select a sample.

Slide (15): Bias

Bias: A process at any stage of inference tending to produce results that depart systematically from the true values; so any factor during the conducting of a research that leads to give untrue values is called bias, for example in my research about the timing of eruption, if I only included males, and then I published my research as it was based on males and females, this is bias, because it is not true, females may have different eruption time than males, this leads to the lack of truth.
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Or it can be defined as any trend in the collection, analysis, interpretation, publication, or review of the data that can lead to conclusions that are systematically different from the truth. Categories of bias: Selection bias Measurement bias Confounding bias

Slide (17): Selecting bias

Selection bias: Occurs when comparisons are made between groups of patients that differ in ways other than the main factors under study. For example if you are examining dental caries among dental age groups, it is not correct to examine caries among different age groups together, and then publish the results, because the rate of caries in children is different from the rate of caries in the old people, so I have to study caries in the young people, and I have to specify an age group. Another example is if you are examining the periodontal tissue without adjustment for smoking, or the gingival health without looking for smoking, smoking is important!!! (the doctor said that I swear :D ), so if I want to study the gingival health I have to isolate
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smokers from non smoker, I cant mix them, because smoking affect the health of the gingiva, so it has to be considered. So any bias based on the methodology in selecting is called selecting bias.

Slide (18): Measurement bias

Measurement bias: you have already selected the sample, and now you want to measure that sample, this bias Occurs when the methods of measurement are not similar among different groups of patient.
Example

How do we examine dental caries? We examine it either clinically (looking to the patients mouth), or we can take radiographs, it is wrong to do research were actually you have examine one group clinically, and another group radiographically, you have to isolate this factor. Another example is when you are examining the working length of the roots using different techniques. in root canal treatment we have to measure the length of the root, we call it the working length, so we have different methodology in estimating the working length, if you want for example to study the working length in some tooth, you have to use only one methodology, or you can use two methodology but you have finally to compare the results.

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Slide (19): Confounding bias

Confounding bias: Occurs when two factors or processes are associated or "travel together and the effect of one is confused with or distorted by the effect of the other, here we have a factor that has been studied and you didnt pay attention to another factor which is important and can affect your results. Example: triglycerides (TG) and cholesterol levels are associated with risk for coronary heart disease, so if we want to study the effect of cholesterol on coronary heart disease it is important to remember that TG can affect the level of cholesterol, so we cannot study only the cholesterol on heart disease without studying the TG. Another Example: Education and/or income with good health, generally educated people have good health, but why do they have this good health? Is it because they have better income and they can look after their body? Or is it because the income allows them to be educated, to become aware about their health? So we cannot study the effect of education on good health without studying the role of income, so we cannot ignore the important role of income when you study the significance of education on good health.

Another good example is the effect of the people taking folic acid to lower the rates of colon cancer, we actually ignore an important thing, people who take folic acid usually take multivitamin, so these are people who are aware about their health, because of that those people
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actually eat properly, do exercise, and know how to look after their body, so here we ignore the health awareness because we only study folic acid and know that it lower the rates of colon cancer without looking that these people are already educated, so it is one of the confounding bias.

Slide (20): Confounding bias

A variable is not confounded if it is directly along the path from cause to effect, if you get a variable that is directly from cause to effect and no other factors affect this pass then it will not be confounded, but if there is any variable that will affect the pass it will be confounded. A confounding variable is not necessarily a cause itself, it can be an effect, for example the healthy people look after their body, and thats why the take folic acid and have lower rates of cancer, now the health awareness has nothing to do with colon cancer but it Is associated with it, so it is not necessarily the cause of avoiding the colon cancer.

Slide (21-22-23-24)

Selection bias is an issue in patients selection for an observation, and so it is important in the design of a study.
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Confounding bias is an issue in analysis of the data, and measurement bias is an issue when you are measuring in your patients. So each bias is related to some stages in a research, the first stage which is the selection of samples or research design deals with the selection bias, the second stage which is the collecting of data and measuring this data this is measurement bias, and the final stage of interpretation of the results is the confounding bias. Often in the same study more than one bias operates, sometimes we have more than one bias not necessarily just one of them, in some cases you may have the three bias together. A distinction must be made between the potential for bias and the actual presence of bias in a particular study; we need to be able to say if there is an actual bias in your study or there is a possibility of a bias in your study, you need to be able to distinguish between these two things. Dealing with bias: as a good researcher you have to be able to identify the presence of bias, and then you have to measure the effect of the bias on your conclusion, if you think that the effect is very small you change the conclusions in a clinically meaningful way, BUT if you think that the effect of this bias is huge than you have to modify the research design.

THE END
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This work is dedicated for our amazing dof3a And especially for the medicine student mo7ammad ziad darabseh DONE BY: AMMAR ANAGREH

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