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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
RESEARCH PROBLEM/QUESTION
No available satisfactory answer Beginning of research ProblemProblem-solving activity Research ? does not justify proceeding to research
What percent of the people think or believe that induced abortion is immoral?
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
Novel concepts & ideas No available satisfactory answer currently Not over-researched in the past over-
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.
Relevant
To scientific knowledge To clinical & health policy To future research direction
Intellectual curiosity SerendipitySerendipity-chance occurrence or accidental discovery Analysis of needs & practices Organized & systematic determination of research needs
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
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?
2. Intervention
Would adding corn oil to their milk formula
3. Comparison intervention
Compared to placebo...
4. Outcome
Lead to faster weight gain?
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
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
HYPOTHESIS
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
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
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
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
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