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A Symposium on Research Techniques

June 14, 2011, Albertus Magnus Auditorium, University of Santo Tomas

Organization of Med Tech Interns
Prof. Ernesto R. Gregorio, Jr. MPH UPM-College of Public Health

References
• A Guide for Research in Health, Nursing and the Social Sciences, Gregorio & mencias (2008), C & E Publishing
• Research Methods in Health & Medicine, Vol 1, Sanchez FS, et al. • Methods of Research, Thesis Writing, Zulueta & Costales (2005) • Foundations of Statistical Analysis for the Health Sciences (2000), Mendoza et al
Research Techniques - Prof. Jun Gregorio, MPH 2

• Epidemiologic Perspective • Will only cover techniques related to identifying research problem up to research designs

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Is doing research a difficult undertaking? • Which step/s in research is/are most difficult to do? Research Techniques . MPH 4 . Jun Gregorio.Prof.

Jun Gregorio. UP Manila Research Techniques .5 Most Difficult Steps in Research Process as Identified by selected UP-PGH Medical Residents . C.2001 • • • • • Designing Methodology Obtaining tools for data collection Identifying research topic Collecting data Writing report • Source: Mencias. et. Al. MPH 5 .Prof. UPM Journal July-Sep 2001.

Other Problems Identified • Time constraints • Competition with other duties and responsibilities • Lack knowledge and skills • Lack of resources Research Techniques .Prof. MPH 6 . Jun Gregorio.

Parallelisms bet Research and Food Preparation RESEARCH • Identify variables to be investigated & plan for data collection • Data Collection FOOD PREP • Determine what recipes to cook and where to buy the raw ingredients • Marketing • Wash.Prof. Jun Gregorio. MPH . pare and slice the ingredients 7 • Data Processing Research Techniques .

MPH .Parallelisms bet Research and Food Preparation RESEARCH • Data Analysis – Transform raw data into information FOOD PREP • Cooking process – Raw ingredients into something edible • Report Write Up so • Garnishing to whet up that users can appetite understand & appreciate the results • Dissemination & • Eating Utilization of ResultsTechniques . Jun Research 8 Gregorio.Prof.

MPH 9 .Research – defined: • A process of gathering data or information by a scientific or logical procedure in order to solve particular problem. Jun Gregorio.Prof. – Galicano-Adanza 2002 • A formal systematic and intensive process of carrying out an in-depth investigation subscribing to a definite format and language and style – unknown Research Techniques .

• Tool of human and environmental development • Sanchez.Prof.Research – Other definitions • A process that follows a careful. well-planned investigation of a problem using the scientific method of inquiry. MPH Jun 10 . organized. FS. • A scientific investigation to discover new knowledge and to test this knowledge. (1996) • MCU Dev’t and Res Center . Research Techniques Gregorio. • Orderly system of solving problem • Tool for growth of science. et. al. objective. MD.

Jun Gregorio. MPH 11 .Prof.Research – Purpose: New Knowledge Skills Improve practice & delivery of services Tools Research New Technology Better Health Research Techniques .

Prof. Applied – application of the results of pure research . According to Goal 1.Fox (1986) Research Techniques .testing the theories and principles . Jun Gregorio.Kinds/Types of Research 1. Basic or Pure – for dev’t of theories and principles 1.2. MPH 12 .1.

1. al. MPH 13 .3.Prof. Descriptive 2. FM. Jun Gregorio. According to level of investigation 2. et. Experimental – Source: Zulueta. Exploratory 2.Kinds/Types of Research 2. Methods of Research & Thesis Writing (2003) Research Techniques .2.

MPH 14 . • Epidemiological research – populations or groups of people. healthy and with disease as subjects – risk factors and causes of disease • Clinical Research – done on patients (phase III & IV) – efficacy and safety of an intervention Research Techniques .Prof.Classification of Research in Medicine • Basic research – healthy humans and experimental animals as subjects. Jun Gregorio.

Jun Gregorio. Design the Tools For Data Collection Design the Plan For Data Analysis Write the Research Report Process & Analyze the Data Data Collection Disseminate The results Utilize the results Research Techniques .Prof. MPH 15 .Steps in Research Process Identification & statement of the problem Review of Related Lit & Studies Define the Actual Problem for Investigation in Clear Specific Terms Formulate testable hypothesis & Define Basic Concepts and Variables Construct the Research Design.

Jun Gregorio.Prof. PCHRD research agenda Research Techniques . MPH 16 .Sources of the Research Problem • Intellectual curiosity or Experiences • Problems in work environment • Serendipity • Organized & systematic determination of research needs – DOH.

Sources of Research Problem • Analysis of needs and practices – Situational analysis – Needs assessment – Gaps in KAP. MPH 17 . Jun Gregorio. technology or skill • Classroom activities Research Techniques .Prof.

research. MPH . dissertation.Sources of Research Problem Discussion w/ KOL.Prof. thesis. Jun Gregorio. special studies Specialists Repetition or extension of investigation Compliance to certain therapy or intervention Evaluation studies 18 Research Techniques . workshops. conferences. health personnel Seminar. conventions Offshoots of other studies.

MPH 19 .Characteristics of a Good Research Problem 1. Feasibility Research Techniques . Significance 3. Jun Gregorio. Researchability 2.Prof.

Jun Gregorio.Characteristics of a Good Research Problem 1. MPH 20 .Prof. Researchability – – Resolved through research & empirical tests Value judgment cannot be tested Research Techniques .

Jun Techniques • Will improve the Gregorio.Characteristics of a Good Research Problem 2. Significance – The problem: • • • • Affects a large population Serious morbidity consequence Related to on-going projects Novel and not over-researched in the past – The answer: • Fills a gap in knowledge or technology • Has practical application Research practice Prof. MPHof the profession 21 .

Characteristics of a Good Research Problem 3. MPH 22 .Prof. Feasibility • • • • Subjects Procedures Resources Time Research Techniques . Jun Gregorio.

population involved. MPH 23 .Writing the Thesis Title • Descriptive. period when data were collected. Jun Gregorio.Prof. concise but comprehensive • Reflects the study variables and what the paper is all about • Includes main concepts (subject matter. the place. • No more than 15 substantive words Research Techniques .

Prof... MPH 24 ..” – “A Descriptive study of ..” – “An experimental investigation of .Writing the Thesis Title • Inverted pyramid • Avoid use of redundant words such as: – “A Study of ..” Research Techniques . Jun Gregorio.

incidence of stroke and age of a person? Research Techniques . • Can be in declarative or interrogative form • To determine the relationship between body mass index. incidence of stroke and the age of a person • What is relationship between body mass index. MPH 25 . Jun Gregorio.Prof.Research Objectives/Questions • Reflect the questions whose answers the investigator wants the study to yield.

Program and Research Objectives Program objective .Prof. MPH 26 . Jun Gregorio.reflects the purposes or the desired output of the intervention being considered To decrease the prevalence of severe malnutrition among preschoolers by 80% within a 2-year period Research Techniques .

with the corresponding value 2 years after program implementation Research Techniques . Jun Gregorio. MPH 27 . To compare the baseline level of prevalence of severe malnutrition among pre-schoolers.Program and Research Objectives Research Objective reflects the questions which need to be answered in order to determine whether or not the program objective has been attained.Prof.

Research Objectives General Objective a generic statement which describe in broad terms what the study wishes to accomplish To determine the effectiveness of nutrition education program for schoolchildren Research Techniques . Jun Gregorio.Prof. MPH 28 .

Prof. Jun Gregorio. logical and manageable components • To compare the level of nutrition knowledge among schoolchildren before and after the nutrition education program.Research Objectives Specific Objective Systematically address the different aspects of the project Break down what is to be accomplished into smaller . MPH indicator 29 . Research Techniques .

Prof. MPH 30 .Research Objectives indicator • To compare the level of nutrition knowledge among schoolchildren before and after the nutrition education program. Research Techniques . Jun Gregorio.

Action Words for Objectives To describe To compare To correlate To determine To establish To verify To identify To calculate Avoid: to understand. to study . to appreciate.

Prof. Jun Gregorio.Critique the ff: Objectives • To study diarrhea • To determine the impact of continuing education for health workers Research Techniques . MPH 32 .

Hypothesis Testing

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Some Definitions
• Statistical inference – concerned with the techniques applied when making conclusions about a population or observation based on results from a sample taken from the same population. • Parameter – a measure describing the population • Statistics - a measure obtained from a sample • Hypothesis testing – process of assessing evidence provided by the data in favor of a statement.
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Hypothesis Testing
• Hypothesis
– statement about the population – Suggested or tentative answer to the research question

• Hypothesis testing – comprises a set of procedures to come up with a decision to either reject or accept the hypothesis
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Schematic Diagram of the Concepts of Statistical Inference

Target Population

Draw conclusion

Unknown parameters
For estimation Or testing hyporegarding

Random Sample Data
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Statistics

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Framing the null and alternative hypothesis
1. The null hypothesis (Ho) is the hypothesis of “no difference” 2. H1 is usually the research hypothesis = hypothesis that the investigator believes in
3. Ho should always be framed in the hope of being rejected so that H1 could be accepted
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An intervention is not effective or more effective than another intervention Research Techniques . Jun Gregorio.Prof. The independent variable is not related/associated with the dependent variable. or 3.Null Hypothesis assumes that association DOES NOT exists 1. Sample is not different from the a population 2. MPH 38 .

Prof. MPH 39 .Examples of hypothesis/es • Null – Prevalence of STH among schoolchildren is not associated with their demographic profile (age. gender. Jun Gregorio. educational attainment of the mother) • Alternative – 2-tailed hypothesis – Prevalence of STH among schoolchildren is associated with their demographic profile • Alternative – 1-tailed hypothesis – Male schoolchildren have a higher prevalence of STH than females Research Techniques .

MPH . Jun 40 Gregorio.Prof. Research Techniques .Example 2 • Null – There is no significant difference between the efficacy of Drug A and Drug B • Alternative – 2 tailed – The efficacy of Drug A is equal to Drug B • Alternative – 1 tailed – The efficacy of Drug A is superior to Drug B (or vice versa).

Prof. Jun Gregorio. MPH B error or Type II error CORRECT DECISION 41 Fail to reject Ho What error will you prefer? .Statement of the Level of Significance Decision Null Ho is false Null Ho is true Reject Ho CORRECT DECISION Alpha error or Type 1 error Research Techniques .

MPH The Person is Guilty B error or Type II error CORRECT DECISION 42 Executed .Prof. Jun Gregorio.Statement of the Level of Significance Decision Released The Person is not Guilty CORRECT DECISION Alpha error or Type 1 error Research Techniques .

Jun Gregorio.Retrospective Observational studies Studies Case-control Descriptive studies Field trials Experimental studies Open-label studies Cross-sectional studies Randomized Analytical studies Cohort Studies Research Techniques . MPH 43 controlled trials .Prof.

MPH 44 .Ways of Categorizing Study Designs • Degree of control of the independent variables by the investigator – Observational/Non-experimental vs Experimental • Objectives of the study – Descriptive vs Analytical Research Techniques .Prof. Jun Gregorio.

Ways of Categorizing Study Designs • Whether or not the study outcome has already occurred – Prospective vs Restrospective • Whether or not the data has already been collected – Prospective vs retrospective Research Techniques . MPH 45 .Prof. Jun Gregorio.

Prof. Cross-sectional 1. Observational 1. Case Studies/Report/Case Series 1. Ecologic 2.3. Jun Gregorio. Cohort 1.Types of Epidemiologic Study Designs 1.1.2.5. Experimental Studies Research Techniques . Case-Control 1.4. MPH 46 .

3. Non-randomized.Prof. Jun Gregorio. MPH 47 2. Quasi-experimental designs O .2. Randomized Controlled Trial 2.1.Types of Experimental Designs 2. non-controlled Study Designs o o o o O “One-shot Case-Study” Design “One-Group Baseline Endline Design Extending design to include additional post-Tx measures Extending design to include additional baseline/pretreatment measures Extending design to include 2 or more experimental groups Non-equivalent control group design Research Techniques .

Prof. MPH 48 .Study Designs Descriptive Studies • case report • case series Observational Experimental Studies Quasi-Experimental Analytic Studies • case-control • cohort Test of Hypothesis Research Techniques . Jun Gregorio.

Prof. Expert Consensus Jun Gregorio.Hierarchy of Evidence • • • • • • • • RCTs Cohort studies Case-Control studies Case Reports Quasi-experimental studies Non-experimental studies Descriptive studies Research Techniques . MPH 49 .

MPH 50 .Case study/report • Study of only 1 case of an illness • Brief and detailed report of single patient’s profile • document rare disease or interesting/uncommon presentations of a common illness • Introduction gives the reason why the case is being reported.Prof. Jun Gregorio. backed by references Research Techniques .

MPH 51 .Prof.Case Series • Describes the interesting characteristics of a groups of patients w/ similar diagnosis (more than 3 cases) • The disease or condition is mainly described demographically and pathologically. Jun Gregorio. • Used as a means to identify the beginning of an epidemic • Leads to generation of hypothesis Research Techniques .

• Establish baseline data and for evaluation. overall or subgroups. • A random sample of population is taken. • Disease magnitude. Jun Gregorio. Research Techniques .Cross-sectional Study (Survey or Prevalence Study) • Determines the presence or absence of disease or exposure at a point in time or over specified period of time. • Prevalence of disease and exposure can be measured. MPH 52 . Hypothesis generation.Prof.

MPH 53 .Schematic diagram of a Cross-sectional Study Onset of study time Exposure Disease Exposure + + .Prof.Total Disease - Total Direction of Inquiry Research Techniques . Jun Gregorio.

Prof. MPH 54 .Prevalence vs Incidence Rate • Prevalence Rate = # with disease # examined • Or = # of existing cases w/in a given period of time # examined Incidence Rate = # of new cases within a given period of time # examined Research Techniques . Jun Gregorio.

MPH 55 . Jun Gregorio.Relationship bet incidence and prevalence Prevalence Rate = Incidence x Duration Prevalence Research Techniques .Prof.

Relationship bet incidence and prevalence Prevalence Research Techniques . Jun Gregorio.Prof. MPH 56 .

Jun Gregorio.Prof.Relationship bet incidence and prevalence Prevalence Death/Cures Research Techniques . MPH 57 .

Prof. • The proportion of cases and controls who have been exposed to a risk factor are determined and compared. Research Techniques . Jun Gregorio. MPH 58 .Case-Control Studies • The most popular observational study design • Persons with a given disease (cases) and persons w/o the a given disease (control) are selected.

MPH 59 .Schematic diagram of a Case-Control Study time Exposed Onset of study Cases Unexposed Exposed Unexposed Controls Direction of Inquiry Research Techniques . Jun Gregorio.Prof.

MPH (without diarrhea) Direction of Inquiry 60 .Prof. Jun Gregorio.Schematic diagram of a Case-Control Study time Exposed Onset of study % % % Cases Unexposed Exposed Unexposed (with diarrhea) Controls % Research Techniques .

Prof. Jun Gregorio. MPH 61 .Computation Disease Status Exposure Exposed Unexposed TOTAL Case a c % Control b d % OR or RR Research Techniques .

• Can evaluate disease with multiple etiologic factors/exposures.Advantages of CC Design • Feasible when investigating rare diseases and those with long latency (chronic). little problem w/ attrition • Relatively quick and inexpensive. • Require a smaller sample size.Prof. MPH 62 . Research Techniques . Jun Gregorio.

Jun Gregorio.Disadvantages • The disease status is likely to influence ascertainment of exposure • Temporal relationship maybe difficult to establish in some situations • Ascertaining exposures based on recall is difficult if the period is too long • Risk of disease cannot be estimated directly Research Techniques .Prof. MPH 63 .

MPH 64 . • Members of cohorts are followed up overtime • Usually prospective Research Techniques . Jun Gregorio.Prof.Cohort Studies • To compare the frequency of the disease among those with exposure and those without exposure.

Prof.Schematic diagram of a Cohort Study Onset of study time Exposed Disease No Disease Unexposed Disease No Disease Direction of Inquiry Research Techniques . MPH 65 . Jun Gregorio.

MPH 66 .Schematic diagram of a Cohort Study Onset of study Exposed (Radiation from X-ray Machine) Unexposed (None) time Malignant Tumor (MT) No Malignant tumor MT No MT Direction of Inquiry Research Techniques .Prof. Jun Gregorio.

MPH Case a c Control b d TOTAL a/ a+b c/ c+d RR 67 .Prof. Jun Gregorio.Computation Disease Status Exposure Exposed Unexposed TOTAL Research Techniques .

Jun Gregorio. MPH 68 .Prof.Advantages • Natural flow – clear temporal relationship • Strongest observational design to prove cause and effect • Useful in studies of rare exposures • Direct calculation of the risk of developing the disease (risk ratio) • Can compute for the incidence of disease Research Techniques .

MPH 69 .Disadvantages • Long period of data collection • Loss to follow-up • Large sample size • More expensive Research Techniques .Prof. Jun Gregorio.

Prof. Jun Gregorio. MPH 70 . • Provide the best evidence for testing any hypothesis and cause-effect relationship Research Techniques .Experimental Studies • Highest form of study design • The strongest of all the study designs since they provide the most control over a study situation. • The observed effect of the intervention is isolated.

MPH 71 .Experimental Studies • Similar to cohort. • Population without intervention/factor is chosen • Intervention/Randomization/manipulation of independent variables Research Techniques . Jun Gregorio.Prof.

Jun Gregorio.Prof. Non-randomized. non-controlled Study Designs o o o o O “One-shot Case-Study” Design “One-Group Baseline Endline Design Extending design to include additional post-Tx measures Extending design to include additional baseline/pretreatment measures Extending design to include 2 or more experimental groups Non-equivalent control group design Research Techniques . Quasi-experimental designs O .Types of Experimental Designs 1. Randomized Controlled Trial 3. MPH 72 2.

Prof.Example 1 99 Average Score 95 Average Score Research Techniques . MPH 73 . Jun Gregorio.

Prof. may not still really due to the intervention Techniques absence of control group 74 due to .1.1. MPH .2. Jun Research Gregorio. One-group pretest-post test (One group baseline-endline) O1 X O2 . Non Controlled) – Studies only one group which receives the treatment or intervention 1.change in measurement is compared. One-group posttest design (One-shot Case Study) X O Impossible to know if any change is due to intervention 1. Pre-experimental designs (Non-Randomized.

No randomization = quasi-experiment.Randomization is a process of ensuring that everyone.Treatment is given to 1 group while it is withheld to the other. . . has an equal chances of being assigned to treatment and control.Manipulation of the independent variables.subjects are assigned to 2 groups (treatment & control) by random allocation.Prof.subjects with disease (Phase 3) are selected. MPH 75 . . Research Techniques . Jun Gregorio. True experimental designs . .RCT .2. .

Schematic diagram of a True Experimental Design Onset of study Tx Inclusi on/ Exclusion Criteria time With Outcome Without Outcome R No Tx With Outcome Without Outcome Direction of Inquiry Research Techniques . MPH 76 .Prof. Jun Gregorio.

Prof. MPH 77 Steroid Inclusi on/ Exclusion Criteria R Baseline . Jun Gregorio.Example of a True Experimental Design Efficacy and Safety of Asthma Treatment time Improved Lung Function No Improvement Placebo Improved No Improvement Direction of Inquiry Research Techniques .

multinational Phase IIIB study in adult with persistent asthma • Inclusion Criteria: – – – – – – Provision of informed consent Out-patients of either sex. MPH 78 . >=12 years of age At 6 months documented history of asthma by ATS Pre-bronchodilatory FEV1 at least 50% of predicted Reversibility of 12% Etc…… Research Techniques . active controlled. randomized. parallelgroup. double-blind.Efficacy and Safety of Drug A compared to Drug B – A 6-month.Prof. Jun Gregorio.

MPH 79 .• Exclusion Criteria – Any significant disorder (cardio. breastfeeding – URTI as judged by the investigators – Participation in a clinical study within 30 days prior to visit 1 Research Techniques .Prof.) – A history of smoking >= 10 pack years (one pack-year = one pack/day for one year) – Pregnancy. Jun Gregorio. etc….

Flow Chart Blinding Drug A Run-in R Drug B Visit 1 2 5 10/20/2011 Research Designs . MPH 80 .Jun Gregorio.

Drug Development • Preclinical testing • Investigational New Drug Application • Phase I A P • Phase II P R • Phase III O • New Drug V Application A • Phase L IV Research Methods and Ethics 81 10/20/2011 .

Also an extremely risky undertaking For every 5.000 to 10.000 compounds being screened Only 2 will progress to large scale Clinical studies Only 1 will reach the market 10/20/2011 Research Methods and Ethics 82 .

Drug development is both timeconsuming and expensive 10/20/2011 Research Methods and Ethics 83 .

Prof. MPH O4 O4 84 .O3 Std Tx/Placebo Research Techniques .O4 • Extending design to include additional baseline measure R R O1.O3. Jun Gregorio.Variations in RCTs • Extending design to include additional posttreatment measures R R O1 O1 X Std Tx/Placebo O2.O4 O2.O3.O2.O2.O3 X O1.

Prof. Jun Gregorio.Research Techniques . MPH 85 .

1.Prof. Non-equivalent control group design . MPH .although control and expt groups may have same characteristics.3. they may still be different in unknown variables (there is no randomization) = O1 O3 X O2 O4 86 Research Techniques . Quasi-experimental designs – No randomization 3. Jun Gregorio.

Jun Gregorio.Prof.Some Definition of Terms Used in Clinical Trials • Blinding • Randomization • Control Group Research Techniques . MPH 87 .

Some Definition of Terms Used in Clinical Trials • Blinding – strategy used to enhance the objectivity of measurements and avoid/minimize biases resulting from subject expectation and observer bias – Involves concealing knowledge of treatment assignment as a means of reducing bias in reporting or measuring outcomes on the part of the: • patient • Those collecting the data • Those analyzing the data Research Techniques . Jun Gregorio.Prof. MPH 88 .

MPH 89 . and tends to create comparison that are similar. Research Techniques . based on chance. It is used to avoid bias on the part of the investigators or the patient. Jun Gregorio. by w/c study participants are assigned to treatment group.Some Definition of Terms Used in Clinical Trials • Randomization – a method.Prof.

Prof.Thank You! Research Techniques . Jun Gregorio. MPH 90 .