(ncbi)national center for biotechnology informationradresidents.net/r1/q bank/part one q...

CD1+2+3 Introduction:

What is the important things in any articles ?

1) Title: has to have enough information in very few number of words about the article

2) Publication : journal . year. volume. pages3) Authors:

i. Corresponding authors: التواصل بامكانك اللي الناس البحث علشان معهم

4) Abstract : context , objective , design , outcome , result , conclusion

5) Introduction : it include i. Gab in knowledge

ii. The objective of study المقدمه اخر في تكون عاده محدد بشكل مكتوبه تكون والزم

6) Methods: i. Here you see is it good or bad study

ii. Include study designiii. In the outcome : you should have only 1 primary

outcome but you can have many 2nd outcomes7) Results:

i. First thing is descriptive (( baseline charactarstic))8) Discussion and comments9) Conclusion10) References

Process of research :

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1) First step : what is the question? تبيله اللي السؤال ايش اجابه

2) Find out what was published before3) Formulate a study design4) Write a proposal and apply for a grant from research

community 5) Collect data and analyse it6) Write a paper and then publish it

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Identifying a research hypothesis

Research question:

1) What area need further study? التسوي جديد شي تسوي يعني مثال بالسرطان التدخين عالقه

2) If so, is there a room for improvement?3) Could my study fill a gap ? والغير المعروف بين بالعلم الفراغ

معروف4) Is it a statement that identifies the problem , a situation or a

topic to be studied?5) Research question is the basis for the development of a

research proposal 6) Is it specific enough to be answerable and researchable ?

Component of a question:

1) Population ---- what specific Pt population will be studied?2) Intervention ------- what specific intervention or exposure of

interest will be studied3) Comparison intervention ------ to what alternative will

intervention be compared ?4) Outcome -------- what do you hope to accomplish?5) Time -------- when will the outcome be assessed in relation

to the intervention?

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Criteria of good research question :

1) Relevance 2) avoid duplication 3) feasibility 4) political acceptability 5) applicability 6) cost – effective 7) time line 8) ethics

-Relevance :

How big is the problem ? who is affected ? how sever is the problem? جيد بحثك يكون عويصه المشكله ماتكون قد يعني

-Avoid duplication:

Review previous study. Identify gaps in knowledge Address disadvantages and limitation of other study Not all duplication is bad تصلح الججديده الدراسه ممكن يعني

غلط كانت معلومه

- feasibility: (( resources needed to carry out the study))

1) Man power حجم على تاثر وهذي معك بيشتغل واحد كم العينه

2) Time 3) equipment 4) mony نقطه اهم-political acceptability :

1) Interest and support of the authorities : this will enhance the chance that the result will be implemented

2) If the study required to show that government policy needs adjustment , one should involve the policy makers concerned in an early stage

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-cost effective:

1) Are the resources of time , mony and manpower we are investigating in the study worthwhile given the result we expect ?

2) What difference or change will the findings of the study make to existing programs?

-time line :

1) Are findings available in time to be used for making the necessary decisions?

2) How urgently the result are needed in order to make a decisions?

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Literature review (( LR ))- it is consists of reading , analyzing , summarizing scholarly

materials about a specific topic- it is a classification and evaluation of what accredited

scholars and researchers have written on a topic , organized according to a guiding concept such as the research objective or the issue you wish to address

why do a LR ?

- reveal existing knowledge- identify areas of consensus and debate- identify the gap in knowledge- Provide a conceptual framework for your research- Identify approached to research design and methodology- Identify other researchers with similar interest- Clarify future direction for research

Characteristics of successful LR : 1- searching 2_ assessing 3_ integrating

1)searching:

1. Find the related articles2. Find the full text online when available3. Your favorite research engine will not find most of the

relevant literature

2)assessing:

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1) To determine whether their findings and conclusions should be relied upon or are likely to be misleading .

2) Some of the research literature on almost every topic is misleading or unimportant

3)integrating:

1) To identify promising future research2) To improve conceptual framework for research3) Determine the advantages and disadvantages of previously

used methods4) This is not easy because the available studies usually exhibit

apparent contradictions

Electronic databasesThe most used is PUBMED

What is pubmed? A world wide web database

(NCBI)National Center for Biotechnology Information

(NLM ) National Library of Medicine

- one of several databases under NCBI enter retrieval system- free access to MEDLINE database of over 16 million citation ,

from 1966 and recently extended from 1949

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http://www.nlm.nih.gov/

- links to the full text versions of articles at websites- over 5000 journals published and 80 countries

*PICO question: for LR “ " سيديات 3 اول في شي اهمPatient / population (characteristics of pt included in

study))

Intervention ( to see the effect of ….)

Comparison (some time you don’t have it)

Outcome ( what are you looking for )

*Boolean operations : 1) and 2) OR

OR : is wider range and better to start with

*PMID “pub med id number” البحث نتيجه تطلعلك كيف يعني بالصفحه

1) authers2) title3) journal, year of publication ,month , volume , issue , page

number4) identification number for pubmed publications “it is specific

for each article”

MESH : to tell pubmed search in all feiled in this topic يعني متشابهه اسماء في االبحاث كل يطلعلك

LR program: 1) End note software

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2) Reference manager software3) Procite software

These programs are bibliographic management software’s that allows you to collect and organize citation and insert the citation into a word processing program in formatted bibliographic styles.

You can search online bibliographic databases , organize your references and images and create bibliographic and figer lists instantly من تضبطك هي البرامج هذي بالعربي يعني

وترتبها تسويها هي الريفرينسيس ناحيه

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Clinical research methodology and introduction to biostatistics.

4-Study design

CD#4 "57 min"

Done by: Ibrahim AL-Omair

Types of research:1- Qualitative: involve interviews and observations – no formal

measurements.2- Quantitative: systematic measurements and quantification

of results. Use of statistics, like blood pressure can be for quality of life, because there is questionnaire that will give numbers.- Most common type in medical field.

Study design:A- Observational studies: two types based on the primary

objective of the study.1- Descriptive studies: has descriptive nature, like

prevalence of hypertension, incidence of myocardial infarction or average survival rate in ICU patients. Ex: case report, case series, cross – sectional study.

2- Analytic studies: like physical activity and hypertension, not only descriptive, it is analysis of association between two factors. Ex: case control studies, cohort studies.

B- Experimental studies: ex: clinical trials:

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Case report:Documents unusual medical occurrence that can represent the first clues in the identification of new diseases or adverse effect of exposures (based on one patient). It is not research because no analysis.

Case series:Collections of individual case reports (based on more than one patient). Not research, like case report.

Cross- sectional studies:Taking snap shot of community or description at point of time. No analysis only description. Cross – section for each patient means that each patient will be seen once over the study time. Also called surveys because most common method of date collection is filling the surveys.

Exposure and outcome are assessed simultaneously among individuals in a defined population, thus at one point of time.

Ex: you assessed the prevalence of HTN and was 25%, also you try to find predictors of HTN like gender, age, education. So, the prevalence is your only primary objective and the association of HTN with gender, or level of education are multiple, secondary objectives. Still its observational study and done at one point at time for each patient.

- Secondary objectives are more analytical in nature.- The samples are taken from the population, and it is not

related to exposure or outcome.- Ex: HTN in Saudi people.- The time is forward.

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- The best way to take a sample is random sample.

Two by two tables: it summarizes my results, can be used for any study type.

Exposure , age , gender

Outcome (HTN)Yes no

total

yes A b A+bno C d C+dtotal A +c B+d A+b+c+d

Prevalence of outcome in exposed = aa+b

Prevalence of outcome in non exposed = cc+d

Prevalence of rate << (PRR) = aa+bcc+d

(We calculate the prevalence)

Ex: prevalence of and factors associated with persistent pain following breast cancer surgery.

- Objective: to examine prevalence and factors associated with persistent pain after surgical treatment of breast cancer.

- Its descriptive nature.- The primary objective (prevalence) decides the study

design.

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- They chose the sample and send them questionnaire and collect it back.

chemo Outcome

Pain no pain

total

yes 664 556 1220

no 879 1088 1967

total 1543 1644 3187

Prevalence of pain with chemo: 6641220 = 54.4%

Prevalence of pain with no chemo: 8791967 = 44.7%

If PRR = 1 = no association

= > 1 = there is association, the pt has more chance to have pain

=<1 = less likely to have pain, so it is protective.

Advantages of cross – sectional study :1- Cheap , fast , simple

Disadvantages :1- You should make that sample represent the population

( random ) Failing to take time in consideration :

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Ex: association of depression with cancer since it is done at one point of time, we don’t know which come first cancer or depression. So cancer patient might have depression at point of time, and depressed patient might have cancer at point of time.

Vulnerability towards biases:

Biases: means error

Types of biases:

1- Selection bias: like selecting non representative group.2- Information bias: wrong way of data collection.3- Confounding bias: if there is other factor affecting the study

and wasn’t taken in consideration. Analytical studies :1- Case control study: study comparing one group with the

diseases and other group without the diseases.- The sample is taken according to their disease

( outcome), unlike cross – sectional (random)- The time is forward, but the directional of the study is

backward (retrospection)

Exposed

Case Not Exposed

Population sample

Control Exposed

Not Exposed

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The sample is not random, it is taken based on certain criteria, which is having the disease or not and based on that we divided them to case and control. Since it is backwards, we look to the history if they had exposure or not.

exposure OutcomeYes no

total

yes a b A+b

no c d C+d

total A+c B+d A+b+c+d

Odds of outcome in exposed:ab

Odds of outcome in none exposed: cd

Outcome odds ration = abcd

= a∗db∗c

Odds ratio: = 1= no association

>1 = associated

< 1 = no associated

Ex: Early life exposure to radiation and US and risked childhood cancer:

- Designs: case control study.

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- Setting : England and Wels - Participants: 2960 child with concerns and 4858 children

as controls.

radiation case control Totalyes 120 185 305no 2570 4672 7242total 2690 4857 7547

Odds of outcome in exposed = 120 / 185Odds of outcome in non exposed = 2570 / 4672

Outcome odds ratio: ab / cd = 1018

So the radiation can increase the risk of cancer in children.

Challenges in case control study:1- Selecting cases:

Should be very specific in your criteria (eligible cases) ex: if you choose very sick patient it will affect your results because you are comparing them with normal control. So your sample should represent its population.

2- Selecting controls: they should represent the population. They shouldn’t be very healthy or very sick.Ex: neighborhood control: you take a patient with cancer then compare him with his neighbor.

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3- Exposure assessment : accurate- The most challenging part - Because we ask people 10 years ago, what was happening

to you. The longer period the less quality. Case control study: ratio control

- Case control studies are not usually taken as one case to one control ration. So we can take more control. In fact, the more control you take the better your study is.

Pitman efficiency : (score) that indicate the strength of the studyIf you increase the number of controls, up to 4 controls: 1 case, it will score the highest on pitman score= strong study.

Advantages of case control study:1- Cheap (no follow up)2- Require short time when outcomes are delayed, It means

it give us an idea about what happened in the last 10 years.

3- We can study multiple exposures at same time, ex: radiation, smoking of the mother, drugs. So, one outcome and multiple exposures.

4- Appropriate for rare diseases.

Disadvantages of case control study:

1- Biases: selection, information ( recall), confounding ( incomplete information) ( other factor)

Cohort study :

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It starts with exposure and goes to the outcome

Defined population (based on exposure)

Outcome

Exposure No Outcome

Sample

No Exposure Outcome

No Outcome

- The time of the study is forward, the direction of the study is forward (prospective)

- Follow up period can be short and can be very long, ex: paracetamol and headache, smoking and cancer.

exp DiseaseYes no

total

yes a b A+bno c d C+dtotal A+c B+d A+b+c+d

Risk on outcome in exposed: aa+b

Risk on outcome in none exposed: cc+b

Relative risk: aa+b

/¿ cc+d

Here we are the incidence:

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(Prospective study)

Incidence : new cancer Prevalence: old cases.

Ex: physical activity and incident cognitive impairment in elderly persons.

Obj: examine whether the physical activity is associated with incident cognitive impairment

- Prospective cohort study.- Physical activity was the exposure.

Physical activity

Cog impairmentYes no

total

moderate 160 1363 1523none 125 459 584total 285 1822 2107

Risk of outcome in exposed: 1601523 = 10.5 %

Risk of outcome in none exposed: 125584 = 21.4%

Relative risk = 0.49

The physical activity is protective for cognitive impairment.

RR (relative risk) = 1 = no association

>1 = associated

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< 1 = protective

- Advantages of cohort study :1- Multiple outcomes: cognitive impairment, M1,

hypertension, obesity.2- Appropriate for rare exposures

- Disadvantages :1- Expensive2- Long follow up3- Loss of follow up

Summary:

1- Cross – sectional study:Exposure

same point of time.Outcome

2- Case control study :Exposure outcome

3- Cohort study:Exposure outcome

Experimental studies :Clinical trials:- Sample based on exposure

Outcome

Exposure No Outcome

Population sample

No Exposure Outcome

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No Outcome

Intervention

- In cohort study: the researcher only observes the people who are exposed and people didn’t get exposed. No intervention

- Individual trials: the researcher will decide who will take the exposure and how will not take the exposure. So the researcher isn’t observer only, he is also the investigator who apply the intervention

- Ex: vit C, E for prevention of preeclampsia in women with type 1 diabetes: randomized placebo – controlled study.

- The good journals required registration number for any clinical trial, before it starts. So you can't change the mythology later on.

Vit C,E PreeclampsiaYes no

total

yes 57 318 375No ( placebo ) 70 304 374total 127 622 744

Risk of outcome in exposed: 57/375 = 15.2% Risk of outcome in non exposed: 70/372 = 18.7%RR (relative risk ) : 0.81 So vit C,E are protective from preeclampsia .RR = 1: no association

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>1: increase risk <1: protective

Ethical Considerations : CD#5

1- Prior knowledge- Enough evidence of efficacy (so you will give the patients

drug that is having evidence to be effective such as previous animal study or clinical study phase 1 or 2) .

- Should not be superior (because if the drug is superior you will give the other group the inferior (control group) which is not ethical).

2- Informed Consent- It might be difficult around time of randomization (as pt.

may be sick and refuse ).

3- Early Stopping Rules- For beneficial and side effects ( so, you will not give a pt. a

drug and ask him to come after 2 years and you don’t know what is happening for him as it may increase mortality or having severe side effects ).

- Data monitoring and safety community (DMC) which is through it you can monitor and follow the pt.

- So. We have to have clear cut when to stop the study .

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Randomization

- Is very crucial as it eliminates the possibility of knowing what the assignment of next pt. will be ( for Ex. If I will choose as a researcher who will take the vit. C I will give it to the healthy group because I know they will get benefit which will affect the study results)

- The critical element in Randomization is the unpredictability of the next assignment .

# Advantages :

- Eliminates conscious bias( selection bias by investigator) it can be done by the computer that he will distribute the pt. as numbers so the investigator will not know what next pt. assignment .

- Averages out unconscious bias ( confounding bias ) like if I choose to assess lung Ca prevalence in association with drinking coffee this is will be biased as the drinking coffee is associated with smoking and increase age which both increase the risk of lung Ca but not drinking coffee itself .

- Groups are “ alike on average” so both groups having similar characteristics e.g. age .

# Disadvantages:- Ethical issues ( sometimes you can’t do a study for ethical

issues so you can’t do randomization)

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- Interferes with pt.-physician relationship ( as the physician is not the one who decide which pt. will take the drug or not but researcher he is the one ) .

- Administrative complexity .- “ alike on average “ does NOT guarantee balanced group .

So, randomization is- To assure equal distribution of confounders .- Each subjects will have same probability of taking the

intervention .- Done by hand(like using a coin probability with each pt.)

or computer .

To assess whether randomization was successful in having comparable groups : assess the quality of treatment groups with regards to baseline characteristics e.g. demographic, clinical and prognostic factors ( because of that usually the 1st table is comparison between age,gander …etc ) .

Randomized trials is superior to non- randomized trials .

Mechanism of Randomization

- Worst : Investigator performs randomization (there will be bias)

- Best : Central, independent randomization center, such as a clinical trial coordinating center ( so when I have a pt. I

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will call the center and they will tell either to give the drug or placebo) .

- Sequenced and sealed envelopes on site ( allocation concealment) so when you get the pt. in you will open the envelope and you will give the drug or placebo based on the information you found) .

- Phone call to central location .- Live response .- Voice response system .- Web – based ( especially in multicenter studies ) .

Types of Randomization :

1- Simple Randomization : use random number table .2- Block Randomization : Pt.s are randomized in blocks .3- Stratified Randomization : Pt.s are randomized within each

areas of risk factor .

Blinding :- It means that certain persons do not know the treatment

assignment ( so you hide the information from people).- Aim : Is to reduce participant and observer bias . This

particularly when the outcome is a subjective measure, such as headache ( so if pt. for example given a drug and he knows this is not placebo, he may feels better by knowing that ).

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# Who Could be blinded ?

- Single blinded : patients- Double blinded : patients + treating clinician\assessing

investigator - Triple blinded : patients + treating clinician\assessing

investigator + statistician .

- Clinical trial could be not-blinded (open labeled) (for example if we compare drug with surgery it is impossible to do it with blinding) .

Comparison Group :

1- Uncontrolled : we give a group of pt. the new drug .2- Controlled : we give a group of pt. the new drug and other

group either placebo or old drug ( better than uncontrolled ) .

Analysis

Relief of pain TotalYes No

Drug A 100Drug B 100

Drug A – 5 pt.s did not take any medications

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- 2 pt.s took drug B

Drug B – 3 pt.s did not take any medications

- 3 pt.s took drug A

So, in interpretation I can use the previous information by 2 ways:

1- Efficacy : here we want to see the real people who took the drug what happened to them ( only who took the drug )


Drug A 96Drug B 96

2- Effectiveness : he we make our calculation based on our distribution of medication ( irrespective how many of them take the drug really) .


Drug A 100Drug B 100

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So…

Efficacy is :

- Potential effect of treatment : whether treatment can have an effect on outcome .

- Compare subjects according to treatment actually received .

- Exclude subjects who complied poorly, switched over or withdrew .

Effectiveness is :

- Actual effect of treatment in the “real world” of people who comply poorly or change treatment .

- It is the same of what we called in research “Intent to treat” .

Advantages of Clinical Trial : Reduced of biases (selection, information and confounding ) .

Disadvantages of Clinical Trial :

- May be impractical or unethical .

- Expensive .- Generlaizability ( because usually we exclude by exclusion

criteria ) .

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Study Design Systematic Review

- Case repot\case series - Case control studies- Cross-sectional studies - Cohort studies

- Systematic review is used when you have conflicting information about certain issue and it means that I would like to combine different studies .

- Systematic review where you review the information from different studies in one topic in a systematic way While meta-analysis is called when you analyze the

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І -Observational study

Descriptive study Analytic study

ІІ - Experimental Studies

Clinical Trials

information from different studies in one topic (summarize the results) .

- Example of meta-analysis

The typical way of arrange the results of meta-analysis

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- Relative Risk > 1 increase risk- Relative Risk < 1 protective

So from previous data, it is conflicting information about Vitamin B6 and risk of Colorectal cancer .

- Because of that we can get the overall result from meta-analysis which will be the final result .

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Best

Internal Validity- Whenever you have bias the study will not be valid and

vice versa .

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Systematic

Review and Met

a-analysis

Randomaized controlled Double

Blind Studies

Cohort Studies

Case control Studies

Case Series

Case Reports

Ideas, Editorials,Opinions

Animal Research

In Vitro"test tube" Research

- Bias : is an error in epidemiologic study that results in an incorrect estimation of the association between exposure and outcome .

- Selection Bias : If sample is not representative of the population (non-response bias, detection bias, loss of follow up …etc). Why we consider “loss of follow up” is a bias ? because may be they didn’t follow up because they are sicker, so the researcher only will follow the healthy individuals .

- Information Bias: If information obtained is systematically inaccurate regarding exposure or outcome (recall bias) .

- Confounding Bias: Is present when the association between an exposure and outcome is distorted by extraneous third variable (factor that affect association).

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Bias

Selection Bias

Information Bias

Confounding Bias

- For Example, like if I choose to assess lung Ca prevalence in association with drinking coffee this is will be biased as the drinking coffee is associated with smoking and increase age which both increase the risk of lung Ca but not drinking coffee itself . So, the association between drinking coffee and lung Ca is masked by another factor i.e. smoking .

- Examples of common confounder are : age, gender, family history, life style and physical activity .

Questions and Answers :-

Q 1

- Odds ratio means proportional (dividing one No. by other)

Myocardial Infarction

No Myocardial Infarction(control)

+ve Physical Activity

20 10

-ve Physical Activity

80 90

100 100

RR = 20⋰3080⋰170 =

But if we double the control(200) RR = 20⋰4080⋰250

If we triple the control(300) RR = 20⋰5080⋰350

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So, we can observe that changing values by changing the No. of control and this conclude that RR is not a good tool for calculation for case control .

But in Odds ratio

Myocardial Infarction

No Myocardial Infarction(control)

+ve Physical Activity

20 A 10 B

-ve Physical Activity

80 C 90 D

100 100

In odds ratio the calculation will be perpendicular instead of horizontal ( like in RR) .

Odds ratio for +ve Physical Activity⋰MI = 2080 = AC

Odds ratio for +ve Physical Activity⋰noMI = 1090 = BD

A⋰CB⋰D → A DBC

Also we can say A⋰BC⋰D because the result will be the SAME = A DBC

So, the conclusion is “ In a case control study, the methodological aspect behind not being able to do RR is that because we are starting with the outcomes “.

Although we calculate perpendicular, we interpret it horizontally (because it doesn’t make sense to say who is having MI are having

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Hx of physical activity BUT we say who is doing physical activity are less likely to develop MI ) .

Q2

Regarding calculation of Meta-analysis, it not just a simple average because every study given a different “Wt.” such as clinical trial will be different from case control study and so on .

Q3

Case control study is appropriate for rare disease BUT

Cohort study is appropriate for rare exposure

For Example : If we want to do study for relation of Retinoblastoma (rare outcome) with using computer ( common exposure ) so it is better to do case control through collecting pt.s with Retinoblastoma and normal population and see how many of them were using computer BUT it is not logic to follow 2 groups, and one of them is using computer and follow them for long time and calculate how many of them got the tumor after 20 years because it is a rare disease and we amy end up with zero .

And vice versa regarding rare exposure for example : radiation exposure( rare exposure) and it’s relation to birth defects(outcome ) ( cohort is better here).

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( In case control, we will collect No. of pt. with birth defects and other group with no defects and see how many of them having radiation Hx and we may end up with zero as it is rare exposure BUT if we collect who exposed to radiation and see what will happen later it will be better “cohort”) .

writing Proposal CD#6

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Definition:

Summery of an idea the research will pursue. Not a detailed one

Should devote time & effort to organize it as it is the whole plan for your research ..so if you plan it bad it will be bad

Should contain all the key elements involved in research process in a concise way.

Should involve sufficient information for a reader to evaluate your study

Intended to convince the committee that your study is valid E.g : research like a trip ..proposal is your trip map as hard as

you plan your study the less surprises you will get in your study

Importance:

1. Draw the map of the study2. Obtain institutional approval3. Obtain institutional board review board "IRB" review4. Obtain funding

Content:

A proposal should address the following

What: what do you want to do ? "objective" Why do you want to do it ? "background i.e :literature

review" & purpose How are you going to do it? "methodology" When are you going to do it and for how long? "duration" How much is it going to cost? "cost"

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Background:

Should contain : Name of investigators, affiliation , contact info, amount of money needed & signature

Provide reader with background information Establish a framework of the study Create interest Lay the broad foundation that created the need for this

study (the gap ) Correlate this study to what already has been known Establish the need for this study Indicates the writer knowledge about the area..the better

proposal you write will indicate that you are sufficient to do this study

Statement of the problem :

The issue that exist in the literature , theory or practice that leads for the need of the study

Should be stated in a simple way so that some one who is not expert in that field can understand it

Should answer why does this research need to be conducted

If this answer is not clear this study is weak & not justified

Purpose:

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Should provide a specific synosis of the whole purpose ot the study

If it is not clear for the writer , it is not clear for the reader Should start with this phrase : the purpose of this study is

to ..… Should be very specific

Methodology:

As important as literature review as the final decision of approving a study is based on it (heart of the proposal)

Most important part of the proposal Should be detailed as much as possible Continuity should be evident & consistent Should correlate with the objective of the study Should contain the following in the same order:

Setting(time , person & place) Design Inclusion/exclusion criteria Sampling Data collection & instrument Data analysis Sample size collection

References:

Only cited references in the text are included Do not include everything you read but did not use

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Should be relevant & updated But not to reference than to refrence wrong Do not copy and paste from any paper without cautation

marks as this is considered as pleasurism

Format of research proposal: There is no universal format , instead there is each

institution has a specific format. Adhere with your institute format

Tips:

Plan the whole process ( co investigators , deadlines) Know what you want to do before doing it The proposal should contain a chain of coherent ideas Should be interesting and informative :

Use heading & subheadings Concise & precise Use simple language (not over simplistic) Check spelling & grammar

Include all the relevant forms Have your proposal read by others ..might show you

mistakes you didn’t pay attention to .

Data collection CD#7

Research process:

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-Planning

-Design

-Data collection

-Analysis:

Data entry Data cleaning Data management Data analysis

-Reporting.

Q- where statistics happen?

Answer> from the binging of planning eg(sample size) till the end of reporting you will use statistics.

-Sample size calculation : is where you statistically determine what is the sample size you need to include in your study in the planning stage .

-the way you analyze different study design is different so you have to know each study design analyzed different so you can plan it will.

Data collection :

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You need to use statistics eg:

If you want to collect information of age it can be measured by :

-date of birth

-how old are you?

-are you between 20-30 . 30-40 …….

Q what is statistics ?

Statistics is a field of science concerned with:

-collection , organization, summarization and analysis of data (descriptive)

-drawing of inferences ‘conclusion’ about a body of data when a part of the data is observer(inferential).

تمثل نتائج على الحصول و دراستها و مجتمع من عينة اخذ يعنيكامل المجتمع

-Biostatistics is the application of statistical method to biological and health related questions . It’s a component required for the completion of an epidemiological study.

Note>> all the previous is about quantitative research NOT qualitative research coz qualitative research has no statistics involved .

Type of variables :

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1- Categorical of variables :Variable in which people are placed or categorized in different group -Death : yes or no-Gender: M or F -Blood group-Education

2-Continuous variables: (there is a continuity of the variables)-Age: 21 y/o , 22 y/o ……….. but I can also make it categorical by making them like <50 y/o or >50 y/o -Blood pressure-weight

Note- all the analysis we do depend on the type of variable as the way we deal with a categorical variable is different way we deal with a continuous variable.

(note: concept of coding “although they are not number I will give them number so I can apply statistics on them ” statistics is not always number as the answer of gender is male or female so what you can do is coding so make it number eg Male will be 1 and Female 2)

Steps involved in a research project: Data collection

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Dataset structure Data entry Data cleaning Data management Data analysis

1- Data collection :Definition: collection of information that will be used to answer a research question .

(wt are the Q you are addressing eg: collect information about age, gender, FHx, QOL,…etc depend on the objective of your study , literature reviews and based on that you decide what information you collect )

Could be done through questionnaires, interviews , data abstraction …..

Regarding questionnaires it s very difficult and run through a long process if possible use a validated questionnaires already exist and tested.

2-Data structure:

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-Structure the database using (SPSS) into which the data will be enterd

>>>That mean informing the computer that when I enter 1 in this place that mean pt is a MALE & when I enter 2 that mean pt is FEMALE

Note>>SPSS(statistical package for social science ) most used program of statistical analysis

3-Data Entry:

-Entering the information (data) into the computer .

-Most of the time done manually but can be done electronically

Can be divided into :

Single data entry(most common) :

All data are entered into one computer

Double data entry:

2 computer and 2 different group are assigned to enter the data in 2 separated computer at the end you can compare between the data entered in the 2 computer so you can identify and small mistake in entry of the data , it’s done for verification of the entry so making sure no any mistakes .

4- Data cleaning :

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Identify any data entry mistakes Correct such mistakes

5-Data mangment :

Creation a new variable based on different criteria, we have 3 scenario

a- Calculation: eg BMI calculation based on 2 different variable you have already hight and wight other examples like MELT score

b- Recoding:

eg marital status : single . married, widow when you did the collection you found out the only 1 person is widow only so you can change the coding into like 1= married 2=single & widow

c-categorization: like when you have continues variable and you want to change it into categorical variable egBP <120 = 1120-140=2 >140=3

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Descriptive statistics

These are the ways for descripting the results :

1- catergorical variables : represented by either A- Tubullation : (tables) contain 1- numbers

2-perscents

always use numbers and percent together for being precise

B-Graphics : (graphics shapes)

1- bar chart : represented as columns

2-pie chart : divided circle

2 - continuous variables : represented by either

A – tabulation 1- central tendency (CT) : one number summarize data

- mean - median - mode

note : CT are not enough bcos they give you one number and may be it doesn’t represent all data

2- dispersion ( give you a range )

-standard deviation (SD)

- variance

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SD: measure difference from the mean , more SD means more variability in results

B- graphic 1- line charts : bcos data are continuous and no end

2- histogram

inferential statistic inference : drawing conclusion on a certain question about population from a sample from this population ( results of sample generalized on all )

Type of inferential statistic :

A : CONFIDENCE INTERVALE : is interval defined by 2 numbers and associated with confidence

CI : help you to generalized you results on population with confidence

( bcos u r going to generalized result of the sample on the population )

note : if you say you have 95 % CI means that 95 % probability that the true parameters are within the calculated range

B- P – VALUE : is related to hypothesis testing

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There are 2 types of hypothesis

1- null hypothesis : when you (of course hypothetically ) no relation between this and that ex : drug and disease or food and allergy

2-alternative hypothesis : when some body argue with you and say there is a relation ship

who is going to judge >>>>>>> p value

if relative risk equal to 1 mean no association >>>> support null hypothesis

if relative risk not equal to 1 meam there is association >>>>> support alternative hypothesis

p value : probability theat the observed difference is due to chance

if < 0.05 means it is not due to chance so reject null hypothesis and support alternative

if > 0.05 mean you don’t know is it due to chance or not so you cannt reject null hypothesis

is there a chance in error in p value >>>>>> yes

2 type of error

type 1 (called alpha error ) : when you reject null hypothesis and it is true

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type 2 ( called beta error ) when you don’t reject null hypothesis and it is false

power of the study = 1 – beta error

the higher the result the more stronger study

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Different statistical tests

CD#9

P- value = Calculated By ................

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If the variables Both CategoricalChi-squared test

If the variables one Categorical & the other Continuoust-test

If the variables one Categorical & the other Continuous (with 3 group or levels)ANOVA test

If the variables Both ContinuousCorrelation

Data Analyses

Univariate analyseswhen u analysing one variable at a time

Bivariate analysesanalysing two variables

Multivariate analyses

*Confounding could be controlled by: Randomization 2 group same characteristics Restrication controlling the population & variables Matching in case-control study Stratification analysing the data each variable alone Multivariate analyses

which is the most effective & the best way to control for confounding.used with two variables & control for other than these variables EX. coffee & lung cancer are variables with controlling for gender OR age

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*Form of research dissemination:

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-Report -Abstract

-Presentation -Poster

-Conference -Manuscript

First thing to be done when we are preparing paper is to prepare tables and figures which organize your finding and they highlight if anything is missing and you will be able to compare it more easily with other pappers

Usually, first table is study population

Second is characteristics of population

Third is major comparison

Then to do reflection which is going back again to literature and review it to compare your study with others and what it may add to previous studies and practise.

After reflection you may do further analysis and often you find many forgotten points

After that you will start writing plan where a lot of local studies stop here, so you need to organize your thoughts and write detailed outline or better give talk to your colleague and see what they will ask about.

Then decide to whome you will write it ( which journal)

Impact factor: is referring to how many people reading the journal or how many people refer to it, the highest number is the best journal (new England journal of medicine is highest)

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Note: you can go to journal website to get instructions about length, formatting, guidlines and better to read one or two papper from the same journal .

In writing is better to start with method section because you already wrote it for your protocol, it contains:

-Study design- prospective or retrospective

-Population- from where,inclusion and exclusion

-Data gathering- instruments and procedure

-Data analysis and sample size

-Ethics, conflict of interest, contributions and better to be detailed

#result section: short 300-500 words, it should be in different paragraphs and contains:

-Study population

-Comparison of main study group

-Main study result

-Secondary analysis

Also mention each table and figure with one key result per table

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#introduction: short 250-300 words contains importance of condition,clinical aspect of interest, identification of gaps in knowledge and objective of study

#discussion : be concise, less than 1000 words and be modest, it contains key message, comparison with other study, limitation, strength and implication

#conclusion: 100-150 words , contains major findings, how it would change practise and if more research is required

#abstract: either structured (which contains parts like objective , method, results etc..) or unstructured ( which is one paragraph together)

Don’t exceed word length which is mentioned by the journal .

#polishing: to re-read and re-write any missing points

Add all information required by your journal and meet their limits

Check references and ask your colleagues to read it

#submission: now mostly online and may require a letter from primary investigator which talks briefly about the study ( cover letter )

You may get response from journals after many months, if they reject just read their review carefully and fix what they need and re-submit

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The key to good research is team work

Good luck for all

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Done By : Dermatlogy Resident

Abulrahman AlJamal

Ibrahim Alomair

Saad Altalhab

Abrar Bukhari

Mohammad AlMeshali

Mana Alharbi

Areej Almazroua

Abdullah Alswied