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of absence (10%) will be deprived and the dr. allowed the .absence of two lectures and he will put lists of absence during this week . Now the lecture Slide2 We have different types of randomized control trial or randomized study or :design, we discuss each of these simple randomized design-1 cross over design-2 factorial study or design-3 Note: slides from (7-12) are not included and they are self reading --:(We will start from slide13 (type of observational studies Dr said it is very important to be able to distinguish between different types of randomized study and different types of observational study so in the exam dr. will bring questions and this questions are examples and you need to understand what this present and what the type of design this present thats why this coarse is very much based on understanding not on memorizing -:Types of observational studies * Cross-sectional studies-1 Prospective cohort studies2Case-control studies-3 Nested case-control studies-4 Ecologic studies -5 last two types will not be discussed and will be left as self reading# (Slide14 (cross sectional studies ???What dose cross section mean You examine the subject as one single time so when you in the lab you do cross sectional of specimen so what do you do here you cross section time ( (
It is easy and fast.1 Information is collected from subjects at a single point of time or at.2 single cross section time
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So you examine the patient once and you dont modify the way they live or you dont give them any thing like drug or medication so to study them you just cross section their time and examine them this is called cross section of study ( ( Used to answer descriptive questions-3 For example: - you want to see what the prevalence of a disease is? Or ?what is the frequency of certain disease So if you want to study this you have to bring a group of people once at single period of time, for example you want to study the frequency of Taurodontism it is when the pulp chamber is elongated so the tooth has very elongated pulp chamber so you want to study the prevalence of Taurodontism among group of people so what you do? At single point of time you take ex-ray for all these people, each one will have an ex-ray for his teeth and then you study those teeth with Taurodontism so by this we called this is cross section of study another example; you want to study the timing of tooth eruption and<< this study the dr. did in the last year so you examine the patients once so this is called cross section *Prevalence is the proportion of individuals in a population who have a specific disease or condition at a particular moment of time so it is: the proportion of people who have the disease to the percentage of all the people who check in a given time () Note: - you need to be able be to distinguish between prevalence and incidence so there are different for example if you want to study about class VI caries, you will examine group of people so you will come up with an outcome so you say that the prevalence of class VI caries is so and so by examining your group at a single point of time thats why this is the prevalence -Used to determine frequency of risk behavior, 4 . Also sometimes can use it to study risk factor, for example you want to study group of people with lung cancer you will see who are smokers among those people e.g.: fifty people with lung cancer you just need to make a quick study to ask questions (who among these people have been smoking) so you study the risk factor or you study smoking so may be the result of people who have lung cancer, 45 of 50 was heavy smoking and thus this is cross sectional study (( 05 54
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(Useful in estimating sample size (will be discussed later-5 Not good in answering analytical questions -6 So the only answer this scripted question so it's difficult to make analytical questions An association found may go in either direction, for example sometimes* the association between two factors goes two ways e.g.: alcohol causes depression but people who are depressed also they may consume alcohol Risk factor may cause the outcome or vice versa * So this type of study (cross section) is not useful to study the relationship between two factors when the effect and cause relationship is not clear or the direction of effect cause is not identified e.g.: alcohol and depression But sometimes in certain studies it is very impossible for association to go the other way e.g.: smoking & facial wrinkles So it is clear that smoking cause facial wrinkles but facial wrinkles cannot cause people to smoke (Slide 16 (Prospective cohort studies What does cohort mean? Is a group of people with certain characteristic for example you want to study dental students in the second year they have certain characteristics for example age 19 years and so ( they're named ( cohort What dose prospective mean? You study a group of people for along period of time not for across section of time Sample is assembled prior to development of the outcome and followed-1 over time So all people who are going to be included in your study should be free of condition that you are studying (( for example you study the incidence of breast cancer all of women should not have breast cancer and you will study this group for 20 year and you will record the number 50 women who developed breast cancer among these 50 women there were 5 women who developed breast cancer for example we say 5:50 or 10%have breast cancer 5 ( 02 01% ( 05
Subjects are evaluated to make sure that they do not already have-2 the outcome being studied So these people should be free of the disease or outcome because sometimes we study something does not necessary a disease
For example I want to study about fraud there is group of people I ask them (are you a cheater) so I have 300 students and thus the prevalence of cheaters for example is 90% or 250:300 but the incidence is different I have 100 students and I study them for 5 year and they shouldn't become cheaters and thus the outcome is not necessary that the outcome is a disease sometimes it is something else such as cheating, a social study Provide much stronger evidence in support of a causal relationship-3 Because you study people over long period of time you can not identify the cause and the effect, for example in the Dr.s study the timing of tooth eruption he couldn't study the effect of premature extraction of deciduous teeth because his study was cross section which was difficult (will divorce affect the eruption or not? for (example So it is difficult to study cause and effect but if he study a group of people over ten years to see the timing of tooth eruption it is very easy to know that this person has a number of teeth lost so he can next time detect the permanent will that emerge faster or slower
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Thats why I can study the occlusal relationship in much stronger way in prospective cohort study Reduce the possibility of reverse causality because it is always the-4 cause to go in one direction
(( Minimizing recall bias-5
What dose recall bias mean? It is bias or error in research because of there is a recall to something that happened to the patient but at the beginning the patient didnt remember thats happened to him or when a person remembers a pervious exposure to a disease
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For example, I have a number of people who are in my study; I will ask them (have you had colic pain like appendicitis?) if there a person 60 yrs old he will not remember but if the injury is painful during this research this is called recall bias
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Information about risk factor is collected ahead of disease * development Recall bias is a problem with case control studies developing * disease make subject remember an exposure So you make a study and there are people having a disease and others dont have disease and I study them over a long period of time and the people who didn't have the disease when they felt pain this
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pain isnt the first time but at the beginning they didnt remember so they dont give accurate information (Slide 17 (Prospective cohort studies Can be used to calculate incidence rate not prevalence -1
Incidence rate is the number of new cases of a particular condition in an-2 at-risk population per unit time So you have to identify the period of time not cross section of time and you have to study these over a long period of time -Longitudinal study3 Means over a long period of time() Length of follow up time is based on how long it takes to develop the-4 disease So you have to select the suitable time to allow disease to develop for example you want to study the incidence of breast cancer it isnt good to study women over 6 months because in this short period of time, you may not have results but you have to study women over 20 yrs by this you will ensure that the women have come in the stage of development of breast cancer of course some of them Remember: in prospective cohort the participants should be free of the outcome at the beginning of the study and all of them should have similar chance or the same possibility of developing the disease or outcome ( ( Slide 18 (Disadvantages: (of Prospective cohort studies* Take a long time to perform esp., when the disease develops slowly -1 For example, breast cancer develops slowly thats why women should be studied over a long period of time cross section) ( Costly and inefficient for studying uncommon diseases (fewer persons-2 (will develop the disease It isnt good in uncommon or rare disease because may be the disease doesnt happen Bias due to loss of subjects to follow up-3 Because this study take a long period of time, people will give up so when we study something longitudinally some of your subjects may drop this study, thats why loss of subjects is a possibility and it is a draw back
( ( Period of temporal changes may influence results-4 Temporal is time so temporal changes will impact on outcome (( *Introduction of new instruments Change in clinical practice * For example, acrylic fillings and now we have amalgam and composite fillings but in the 50th century they used acrylic fillings if someone made a study on acrylic over a long period of time this isnt good because the result is no longer important and this filling will be old fashion Other example about the implant it is important now rather than denture and if someone made a study on dentures so there sometimes a change in clinical practice And introduction of new instrument (( Answer of research question may become less relevant when the study-5 is complete So the studies are always renewed such as study of dentistry For example, when the dr. was a student they told them that the theory of tooth eruption is the attachment and reattachment of periodontal ligament now last year dr. told us that the most acceptable theory is contractility of the hyproplast and hydroststic pressure ( 02 ( (Slide 19 (case-control studies Subjects are assembled based on whether they have experienced the * (outcome (cases) or not (controls So you group people in two groups based on whether they have the outcome or not So one of them have outcome (case) and other doesnt have outcome ((control Not like prospective cohort study that should be free of conditions For example, I choose people with gingivitis (cases) and I choose people (without gingivitis (control And then I study them Frequencies of risk factors are compared between cases and controls * Slide 20 (advantage: (of Case-control studies*
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Efficient especially for studying uncommon diseases * So if you have uncommon disease the best way is to do the case here if you're in case-control studies >> I choose 5 people with disease (cases) (and 5 people without disease (control So they should belong to same population or the same range or same race :Disadvantages* -Cannot be used to determine prevalence and incidence1 !?!Because the cases have disease already so what I shall study Selection bias: loss of cases/controls prior to their selection (a case died-2 (prior to assembly of cases, then the sample wouldnt be representative So sometimes when you study there are loss of cases or control and sometimes this loss can be prior to their selection such as cases died prior to assembling sample so sample wouldnt be representative ( ( Recall bias-3 Cases are more likely to remember exposures than controls * () For example, we have cases with cancer may report previous exposures because they have been more aware about their health and subjected to many previous tests ) 5 5 , ( Slide 21 Case-control studies >>> *Can be matched and unmatched *Matching Individual matching -1 Each case is individually matched with one or more controls * So the person with a disease should be matched with a normal person both of them should be the same age and same population, for example: 45yrs old man as case matched with 45 yrs old man as a control ( ( -Frequency matching2 Controls are matched to cases as a group * Similar distribution of cases and controls on each matched variable * E.g., males with range of 20-40 yrs account for 30% in both groups () 02-04 03% Slide 22 :Advantage of matching * Eliminate confounding 8
The cases and control should be the same population and same age and same exposure to risk factor so this is eliminating confounding prostate cancer ) ( *Disadvantage of matching Increasing difficulty and cost of identifying controls esp., with limited-1 number of potential controls So sometimes it is very difficult to find a match of certain people E.g., 45 yrs old male with prostate cancer (( 54 Matching for a variable will not enable to study its impact on the-2 outcome E.g., matching for smoking to study the effect of diesel fumes on lung cancer ) ( disadvantage Best to avoid matching except in small studies where it is difficult to * adjust statistically for all possible confounders unless if matching is used So I always avoid the matching unless there was statistically I will use the matching because it is necessary \"Slide 23 /case-control cont How many controls per case to enroll * The best is for one case to select one control Greatest efficiency with equal number * But sometimes the disease is very rare and only I have 3 cases of this disease so may be it isnt wise to select 3 controls so I choose for each case a number of controls enough cases cannot be obtained such as in rare conditions * increase the power of the study So I choose for each case 3 controls, and thus I increase the capacity of study there are more than one variable/confounder to match on *
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So if you have more than one variable, you should choose 3 cases and 3 controls and each one have to study a particular variable *Maximum: 4 controls per case Slide 24 & 25 is self reading and not included# (Slide 26 (Specifying a hypothesis What are you hoping to prove before data collection (what are u* (?going to do So before you start, you have to put hypothesis for your research design For example, the study is prevalence of caries among dental students so the hypothesis will be (what is the prevalence of (?caries in dental students This is the research question is called hypothesis (( :it has two forms* null form-1 There is no difference or no association or no correlation, so when you study the effect of smoking on lung cancer you say (smoking is independent of lung cancer or doesnt cause the lung cancer?) this is called hypothesis Alternative form -2 There is a difference There is effect smoking on lung cancer you always put hypothesis in two forms (null & alternative) all# the time Study hypothesis is stated in both the null and alternative forms * Statistical analysis is based on inferential reasoningSo for example, you want to study effect of smoking on lung cancer you put hypothesis in null form (smoking is independent (of lung But in the end of the study you find that smoking cause lung cancer by 90% In this case you reject the null hypothesis and accept alternative form (Slide 27 (Inferential reasoning
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Assessing the probability that an association found in a sample * could have occurred by chance if there were no true association in the population If the probability that the association could have occurred by * chance falls below (p<0.05), null hypothesis is rejected and alternative hypothesis is accepted So if the ratio of chance of is less than 0.05 so null hypothesis will be rejected because the possibility is less than 0.05 chance isnt make real association# Slide 28 (A study with more than one question) is included but self reading Collecting data on more than one outcome * Collecting data on additional risk factors for the same outcome does not answer multiple questions *Multiple outcomes -Different stages of the same disease process Smoking on angina, MI and death Different disease processes influenced by the same risk factorSmoking on gingival health, lung cancer and heart disease -Outcomes unrelated to one another Smoking on health and cost Slide29 (sample size) discuss later (Slide 30 (Ethical approval *Human research committee Protect the rights of subjects-1 -Insures that the subjects fully informed2 Insures that subjects have consented to participate-3 Insures that the risks are reasonable an much less than the new-4 knowledge/ benefit that the study will provide -Insures that confidentiality is maintained5 Any study should be passed to ethical committee and accept it * ) ( The END Sorry for any mistake DONE BY: ARWA ODEH Special thank for duaa abu hamid, nada nammas ,sanaa qasem
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: Waad,Ruba,Sara,Dalia,Alaa,Amna Each of us has his way in life, but wherever we go every other part of the bears
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