ESSENTIAL ELEMENTS of RESEARCH

PROF.1 JUDITH M. SISON, MD, MPH, FPOGS

Epidemiologic Process
Researchers:  Define the problem: ask a well focused question  hypothesis statement  Identify the cause: test the hypothesis  is there an association between exposure and outcome  Interpret the results:  threats to validity (bias, confounding),  role of chance

RESEARCH


Quest for knowledge thru diligent search/ investigation/experimentation Search 1st for existing answer/s available data in literature if there is no satisfactory answer RESEARCH

RESEARCH
Types based on broad objectives SUBJECTS AIMS ENDENDPOINTS
BASIC EPIDEMIOLO- CLINICAL EPIDEMIOLOGICAL populations, healthy or w/ disease identify risk factors & causes of disease

healthy humans & experimental animals develop better understanding of the nature and relationships of normal events basis for future application in Medicine

patients
understand disease process including determinants of illness outcome devpt of technology for dx & tx of disease

devpt of preventive measures

RESEARCH PROBLEM/QUESTION
   

No available satisfactory answer Beginning of research ProblemProblem-solving activity Research ? does not justify proceeding to research

CHARACTERISTICS of a GOOD RESEARCH PROBLEM



Researchable: data can be collected to resolve/answer the problem

A PROBLEM THAT REQUIRES VALUE JUDGMENT CAN NOT BE TESTED  e.g. Is induced abortion immoral? Is in-vitro fertilization acceptable? in

What percent of the people think or believe that induced abortion is immoral?

CHARACTERISTICS of a GOOD RESEARCH PROBLEM



Significant: Significant: potential answer is worth the effort, time & resources; it matters
ProblemProblem-affects a large population has serious morbidity consequences related to on-going projects on Answer-fills a gap in knowledge or technology Answerhas practical application improves the professional practice


CHARACTERISTICS of a GOOD RESEARCH PROBLEM

Feasible: practical
adequate subjects can be gathered for the study information needed can be collected technically possible procedures available resources can be completed w/in a reasonable time frame

Novel concepts & ideas No available satisfactory answer currently Not over-researched in the past over-

CHARACTERISTICS of a GOOD RESEARCH PROBLEM



Ethical
No form of harm should be inflicted on anyone at any stage of the research  Includes securing informed consent from the subjects  Treatment options are also impt in cases wherein there may some signs of failure during the process.


CHARACTERISTICS of a GOOD RESEARCH PROBLEM



Relevant
To scientific knowledge  To clinical & health policy  To future research direction


Interesting to the investigator

SOURCES of RESEARCH PROBLEMS in MEDICINE

 

 

Intellectual curiosity SerendipitySerendipity-chance occurrence or accidental discovery Analysis of needs & practices Organized & systematic determination of research needs

SOURCES of RESEARCH PROBLEMS in MEDICINE

       

Medical literature Journal clubs National meetings Teaching or academic affiliation Community health concerns Mortality/morbidity cases in the locality Discussion w/ colleagues, students, friends, media Presence of new technologies

     

Skepticism Careful observation of patients Unresolved problems Creativity Problems encountered in field work or clinical practice Interesting occurrences w/c need explanations or reporting Personal experiences

CLINICAL QUESTIONS


Issues:
        

Abnormality healthy/sick Diagnosis - accuracy Frequency Risk Prognosis consequences Treatment - change course of disease Prevention Cause Cost

FORMULATING a RESEARCH PROBLEM



Topic of interest: who? where? what? why? when? how?

General area: health problem in a factory  Specific: exposure to chemicals & effects


Deals with:
Characteristics of event: What are the adverse effects of working in a chemical factory?  Relationship between factor & event: Does exposure to chemicals in the factory produce adverse effects?


FORMULATING a RESEARCH PROBLEM

Write in question form clear & specific e.g. Clear terms: effectiveness instead of benefits accuracy instead of useful Specific: Does long-term exposure to lead longresult in infertility?  Use measurable & operational terms


Elements of a well-built clinical wellquestion

1. Patient or problem
Among low-birth weight neonates...

2. Intervention
Would adding corn oil to their milk formula

3. Comparison intervention
Compared to placebo...

4. Outcome
Lead to faster weight gain?

RESEACH (?) FORMAT for a COMPARATIVE STUDY



Essential elements:


1. Biologic/theoretical rationale
whether there is scientific basis for the issues addressed in the (?)  Is there a logical/reasonable basis for the answer to the (?)


2. Study population  3. Study Intervention /maneuver/exposure  4. Outcome of interest  5. Comparison to be made  6. Study design


RESEACH (?) FORMAT for a COMPARATIVE STUDY

e.g. Among UST-FMS 1st year students, AY2008 (#2P), UST(#2P), is the proportion (#4O) of students w/ passing grades after the 1st semester the same (#5C) for graduates of private versus those of public colleges (#3E) ? #1 (implied)-subsequent academic performance is not (implied)affected by the type of college the student graduated from #6 (implied)-all students classified into graduates of (implied)private colleges & graduates of public colleges


CLARIFICATION of the RESEARCH PROBLEM

Breakdown the problem into smaller components or sub-problems sube.g. What is the magnitude and pattern of coronary artery disease in Manila?



Prevalence & mortality rates by:

a. Geographic distribution in Manila  b. personal characteristics: age, gender, marital status, social class, occupation


Monthly mortality rate

CLARIFICATION of the RESEARCH PROBLEM



Provide state of the art information, what has been done, & the methods used in resolving related/similar problems:
Literature review  Consultation with experts


HYPOTHESIS
Tentative answer to the research problem e.g. The morbidity & mortality rates of coronary artery disease in Manila are moderately high.  Statement about the population w/c is being tested in the light of the current data


HYPOTHESIS


Types: Null (Ho) & Alternative (Ha)  Null (Ho)-assumes that association does NOT exist (Ho) Sample is not different from a population  Independent variable (suspected cause) is NOT associated w/ the dependent variable (outcome)  An intervention is NOT effective or more effective than another intervention

e.g. Coffee drinking does not cause coronary artery disease.

Metoproterenol & theophylline have equal efficacy in the treatment of asthma

NULL HYPOTHESIS (Ho)

No difference, no association, no relationship  Contains a statement of equality, either =, , e  Needed in statistical testing  e.g. Research problem: Dept. of Health selection of employees for management training (males vs females) P1 = proportion of males selected for training P2 = proportion of females selected for training Ho: P1eP2 P1e


HYPOTHESIS


Alternative (Ha)-opposite of Ho (Ha)assumes that an association exists

Types: 1-tailed & 2-tailed 12

1-tailed Ha (directional): gives the direction of the relationship states w/c is greater when 2 samples are being compared e.g. Metoproterenol is more efficacious than theophylline in the treatment of asthma. SocioSocio-economic conditions & drug abuse are inversely associated.

1-TAILED HYPOTHESIS

Appropriate for testing intervention



e.g. The percentage response w/ drug A >B

 

More specific Sample required is smaller

ALTERNATIVE HYPOTHESIS (Ha)

Of interest to the investigators usually  Useful in testing risk & prognostic factors  Research problem: Dept. of Health selection of employees for management training (males vs females) P1 = proportion of males selected for training P2 = proportion of females selected for training
 

Ha: P1>P2 This is the claim w/c the women are trying to prove

HYPOTHESIS


2-tailed Ha (non-directional/positive): (non Does NOT indicate direction of association such as whether it is direct or inverse or w/c is greater when 2 samples are being compared  Interest is to detect a association /difference regardless of direction e.g. Metoproterenol & theophylline differ in efficacy in the treatment of asthma. SocioSocio-economic conditions & drug abuse are associated.

HYPOTHESIS


Researcher usually conducts hypothesis testing to gauge the amount of support for Ha = research hypothesis


Ho may also be the hypothesis of interest=research hypothesis

 

Ho & Ha are complimentary Formulated before collecting or analyzing data

HYPOTHESIS


Importance:  provides the basis for the testing of the statistical significance of study findings  Essential in sample size determination to produce statistical data of adequate reliability Formulation:  Valuable to include information on the degree of relationship if available e.g. The incidence of coronary artery disease is five times greater in cigarette smokers than in nonnonsmokers. The efficacy of metaproterenol in the treatment of asthma is 50% greater than that of theophylline.

EPIDEMIOLOGIC HYPOTHESIS


ELEMENTS:
    

Population Environmental exposure cause Expected effect disease DoseDose-response relationship TimeTime-response relationship

e.g. Among adults w/o previous exposure to typhoid fever (TF), the ingestion of 10 million viable typhoid bacilli will result in an attack rate of TF of 50% w/in a period of 30days.

EPIDEMIOLOGIC HYPOTHESIS


A well-developed hypothesis describes each of wellthese elements w/ a high degree of specificity to be testable & therefore useful by providing basis for further investigation In practice, the components of an epidemiologic hypothesis are often less well-specified & may wellbe no more than implied


e.g. Dirty water causes diarrhea.

RESEARCH OBJECTIVE
  

  

Aim/goal of an action Target outcome/Defines the expectations Gives direction  Indicates relevant variables to be considered  Guides the choice of research design & methods  Indicates what data to collect  Influences how data should be analyzed  Serves as bases for the interpretation of results Solution to the research problem Essentially a statement of the hypothesis as expected outcome Types: General & Specific

GENERAL OBJECTIVE
States the overall purpose of the study  Declarative expression of an intended action addressing the research question usually introduced by the phrase to determine or similar phrases  Derived from the research ?/problem & H e.g. To establish the magnitude & pattern of coronary artery disease in Manila. To determine the adverse effects of working in a chemical factory. To determine if there is a relationship between sociosocioeconomic background & drug abuse.


SPECIFIC OBJECTIVE/S
 

Clearly state the specific expected outcomes Contain the specific hypothesis & corresponding variables Mention the measurement tools & quantifiable outcomes preferably in terms of indicators

SPECIFIC OBJECTIVE/S
e.g. Gen. obj: To determine the effectiveness & safety of vaccine A against meascles. Specific objs: 1. To determine how long it takes for the vaccine to take effect. 2. To determine the duration of effectiveness of the vaccine. 3. To determine if the incidence rate of meascles in the vaccinated grp is lower than in the controls. 4. To determine if the frequency & severity of advere reactions are more in the vaccinated grp than in the controls.
 

If these specific objs are achieved, the investigator would be able to conclude if the vaccine is effective and safe.

CONCEPTUAL FRAMEWORK
High Ampalaya 1g BID & Diabetics Type2 Non-pregnant No co-morbidities FBS & OGTT Age BMI Lifestyle Dibenclamide 500mg BID & Placebo ampalaya Low Normal R High Placebo Dibenclamide Normal Low

SIMILARITIES between a RESEARCHER & PRACTITIONER

RESEARCHER  Concerns w/ impt scientific (?)  Formulates H from scientific (?)  Tests H by experimentation  conclusion

PRACTITIONER  Concerns w/health problems  Formulates/explains the observation & lists down ddx  Examines patient, utilizes lab tests  confirm dx determines effects /outcome of Rx