MODULE 4 Flashcards
is the basic research or applied research conducted to aid the body of knowledge in the field of medicine
MEDICAL RESEARCH
TYPES OF RESEARCH
- presents data in the form of NUMBERS and STATISTICAL RESULTS
- variables are clearly uderstood & defined in advamce by the researcher
- Reality is objective, “out there”, and independent of the researcher
- determines the “WHAT”
QUANTITATIVE RESEARCH
TYPES OF RESEARCH
- presents data in the form of NARRATION with WORDS
- Researcher may have only rough idea about variable in advance
- Reality is subjective; multiple realities exist in any given situation ( these realities are seen by the participants in the study)
- determines the “WHY & HOW”
QUALITATIVE RESEARCH
it is the basic research, applied research or translational researches conducted to aid and support the body of knowledge in the field of Clinical Practice
BIOMEDICAL RESEARCH
it is the process of reading and evaluating article, journal, literature and scientific study in a systemic way to reach at a conclusion that one can interpret itseld whether the study results are scientifically proved and applicable to clinical practice
LITERATURE EVALUATION
is reading already an evaluation
yes
a FRAMEWORK, or the set of METHODS and PROCEDURES used to collect and analyze data on variables specified in a particular research problem
STUDY DESIGN
a fast but expensive type of research
EXPERIMENTAL STUDY
cheap but time consuming type of research
OBSERVATIONAL STUDY
these type of studies requires a lot of time (years)
cohort
case control
cross-sectional
focus on NOVEL or UNSUAL signs, symptoms, or events
DESCRIPTIVE RESEARCH DESIGNS
DESCRIPTIVE RESEARCH DESIGNS
- a description of an INDIVIDUAL with a novel or unusal condition
- describe an individual case
CASE STUDY
DESCRIPTIVE RESEARCH DESIGNS
- a SUMMARY of the health status of SEVERAL individuals who all display similar novel clinical finding or condition
- describe a number of (CONSECUTIVE) cases
CASE SERIES
DESCRIPTIVE RESEARCH DESIGNS
- uses SURVEYS to gather data about varying subjects.
- the data aims to know the extent to which different conditions can be obtained among these subjects
DESCRIPTIVE SURVEY
investigator assesses the STATUS OF THE EXPOSURE and the OUTCOME
OBSERVATIONAL RESEARCH DESIGNS
OBSERVATIONAL RESEARCH DESIGNS
present - present
CROSS-SECTIONAL study
OBSERVATIONAL RESEARCH DESIGNS
present - future
prospective cohort study
OBSERVATIONAL RESEARCH DESIGNS
present - past
retrospective cohort study
case-control study
retro
past
pro
future
- an observational study in which subjects are sampled based upon presence or absence of disease and then their prior exposure status is determined
- both exposure and outcome (disease) have occured BEFORE the start of the study
- the study proceeds BACKWARDS from effect to cause
- uses CONTROL or COMPARISON group
CASE-CONTROL STUDY
CASE-CONTROL STUDY
subjects are sampled based upon ____
presence or absence of disease and then prior exposure
CASE-CONTROL STUDY
both exposure and outcome have occured ____ the start of the study
BEFORE
CASE-CONTROL STUDY
the study proceeds ____ from effect to cause
BACKWARDS
CASE-CONTROL STUDY
uses ____ or ____ group
control or comparison
drawback of CASE-CONTROL design
BIAS
- a systematic error in the design, conduct, or analysis of a study that results in a mistaken estimates of effect of the exposure on disease
- data cannot be used to calculate the incidence or prevalanec of the condition under the study
- do not constitue a random sample
- consequence: measures of risk
BIAS / selection bias
Case-control studies are particularly advantageous for studying ____
outbreaks of diseases
advantageous for studying OUTBREAKS of diseases
case-control studies
- defined with respect to their exposure to a particular variable and a relationship is sought between this factor and several outcome variables
- groups are distinguished based on an event NOT arranged by the investigator within a defined time period (age, occupation, exposure)
COHORT STUDY
COHORT STUDY
are those in which both the exposure and the outcome have occured BEFORE the investigation begins
RETROSPECTIVE COHORT DESIGN
____ design is efficient when a disease is relatively COMMON and when the interval between the event and the outcome is SHORT
COHORT STUDY DESIGN
the ____ design is also valuable in estimating the INCIDENCE of the disease under study
COHORT STUDY DESIGN
COHORT STUDY
potential difficulty
outcome may occur many years after exposure
- used to determine the PREVALENCE of an exposure, an outcome, or an exposure outcome assocaition at a single point in time or during a brief time interval
- useful in porviding a snapshot of the number of individuals who exhibit the variable in question
CROSS-SECTIONAL STUDY DESIGN
most important in conducting a study
TIME
outcome =
disease
- studies that are designed to ANSWER question or a hypothesis in a prospective manner
- involves a measurement of an intervention
EXPERIMENTRAL RESEARCH DESIGNS
- a study in which people are allocated at random (by chance alone) to receive one of several clinical interventions
- one of these interventions is the standard of comparison or control
- the control may be a standard practice, a placebo, or no intervention at all
- this seeks to measure and compare the outcomes after the participants receive the interventions
- a QUANTITATIVE study
RANDOMIZED CLINICAL TRIAL
RANDOMIZED CLINICAL TRIAL
someone who takes part in a RCT is called a
participant / subject
RANDOMIZED CLINICAL TRIAL
what type of study
QUANTITATIVE
RANDOMIZED CLINICAL TRIAL
already available in the market
POSITIVE control
RANDOMIZED CLINICAL TRIAL
placebo
NEGATIVE control
- may be either qualitative or quantitative
SYSTEMATIC REVIEW
SYSTEMATIC REVIEW
Researchers conducting QUALITATIVE systemic reviews use ____ and ____ to evaluate and synthesize the results of individual investigations
rigorous logic and critical thinking
SYSTEMATIC REVIEW
Researchers conducting QUANTITATIVE systematic reviews, use ____ to ddescribe the magnitude and ocnsistency of the experimental effect
STATISTICAL METHODS
QUANTITATIVE systematic reviews is also termed as
meta-analysis
____ answers a DEFINED RESEARCH QUESTION by collecting and summarizing all empirical evidence that fits pre-specified eligibility criteria
SYSTEMATIC REVIEW
____ is the use of statistical methods to summarize results of these studies
meta-analysis
determine the EXPOSURE variables associated with an outcome
CASE CONTROL
determine OUTCOMES associated with exposure variables
COHORT
Obtain evidence of exposures, outcomes, or their association
CROSS-SECTION
establish cause & effect relationships between interventions and outcomes
RANDOMIZED CONTROLL TRIAL
synthesize findings from individual studies to provide a coherent, integrated answer to a focused research question
SYSTEMATIC REVIEWS
- assemble groups that differ only in EXHIBITING OUTCOME
- determine if groups differ with respect to suspected antecedent EXPOSURE FACTORS
CASE CONTROL
- assemble groups that differ only in EXPOSURE
- determine if groups differ with respect to SUSPECTED OUTCOMES
COHORT
- gather information on exposure and outcome at a single point in time
CROSS-SECTION
- examine differences in OUTCOMES among groups receiving intervention compared to a placebo or active control group
RANDOMIZED CONTROLLED TRIAL
- use critical thinking approach to gather, evaluate, and synthesize information from individual research studies to address a question of clinical relevance
SYSTEMATIC REVIEWS
- study group selected based on the exhibiting OUTCOME of interest
- control group matched on all relevant variables except the outcome of interest
CASE CONTROL
- study group selected on the basis of exhibiting EXPOSURE of interest
- control group mathced on all relevant vaariables excpet EXPOSURE of interest
COHORT
- group membership may be determined before or after data are gathered
CROSS-SECTION
- assignment to an intervention or control group is result of a RANDOM process
RANDOMIZED CONTROLLED TRIAL
- study results are weighted with respect to methodologic quality
SYSTEMATIC REVIEWS
- rare outcomes, long exposure outcome intervals
- inexpensive and easy to conduct
- can be completed quickly
CASE CONTROL
- can be used to study HARMFUL exposures
- can establish incidence of outcome
- exposure effects can be examined retrospectively or prospectively
- best with RARE exposures
COHORT
- can be used to study many potential exposure-outcome associations
- can be used to examine many subgroup variables
- subgroups can be oversampled
- can be used to study harmful exposures
- data can be obtained easily, rapidly, and cost-effectively
CROSS-SECTION
- minimizes bias
- control group change in response to variables over time
- can examone more than one intervention; more than one outcome
- can be used to establish cause & effect relationships
RANDOMIZED CLINICAL TRIAL
- methodologic guidelines, focused, transparent, and obejctive
- can detect intervention-outcome relationships that may be obscured in individual studies
- can explore differences among studies
- EXTREMELY COST-EFFECTIVE
- study is quickly completed
SYSTEMATIC REVIEW
- susceptible for many different forms of BIAS
- groups cannot be matched on all variables except EXPOSURE
- may be difficult to determine time relationship between exposure and outcome
- at best, evidence indicates an association between exposure and outcome
CASE CONTROL
- susceptible to CONFOUNDING
- groups cannot be matched on all variables except outcome
- inefficient for long exposure-outcome intervals
- may be EXPENSIVE
- requires more patients than case-control study
COHORT
SYSTEMATIC REVIEW
- susceptible to BIASES, especially recall bias and volunteer bias
- often relied on non-verified, self-reported information
- susceptible to cause & effect conclusions
CROSS SECTION
- cannot be used to study effects of hamrful interventions
- can be expensivve and LABOR INTENSIVE
- participants who drop our can compromise advantages of randomization
- multicenter patient group may not be similar to an individual clinician’s patient group
- must consider role of commercial sponsors who have a vested interested in study outcome
RANDOMZIED CLINICAL TRIAL
- WEAKNESS of any observational study, notably selection bias
- studies with larger samples, or higher quality, count more
- studies with methodologic flaws are included
- the data summary methods obscure fine points of subject, setting, and methods that are essence of clinical practice
- meta-analysis of observational studies is not recommended
SYSTEMATIC REVIEW
investigates relationship between two variables (or more) without the researcher controlling or manipulating any of them
CORRELATION
asses the bioequivalency of two or more products
BIOEQUIVALENCE STUDY
evaluate uses and adverse effects associated with newly approved drug therapies
POST MARKETING SURVEILLANCE
report observation on SINGLE patient
CASE REPORT
evaluate stability of drugs in various preparations
STABILITY STUDY
report observatin on SERIES of patiens
CASE SERIES
HIERARCHY OF EVIDENCE
top to bottom
Systematic Reviews
Randomized Control Trials
Cohort studies
Case-control studies
Case series, Case reports
Editorials, expert opinion
- use of current BEST EVIDENCE in making clinical decisions about the care of individual patients
- it involves integrating the clinician’s expertise with the best available external clinical evidence derived from systematic research to maximize the benefit for the patient
EVIDENCE-BASED MEDICINE
____ is part of EBM
crtical appraisal
CRITICAL APPRAISAL
____ the best evidence
find
CRITICAL APPRAISAL
____ its quality
appraise
CRITICAL APPRAISAL
____ the findings to the practice
apply
the process of carefully and systematically examining research to judge its trustworthiness, and its value and relevancec in a particular context
CRITICAL APPRAISAL
two broad questions that critical appraisal generally seeks to answer
- is this study likely to be accurate (validity)
- can we use its findings (relevance)
BASIC ELEMENTS OF A SCIENTIFIC PAPER
a brief desccription on the article’s subject
TITLE
BASIC ELEMENTS OF A SCIENTIFIC PAPER
informs the reader who conducted the study
AUTHORS
BASIC ELEMENTS OF A SCIENTIFIC PAPER
- condensed summary
- background and purpose
- methods
- results
- conclusion
ABSTRACT
PARTS OF ABSTRACT
Background
methods
results
conclusion
BASIC ELEMENTS OF A SCIENTIFIC PAPER
objectives/hypothesis
background and purpose
BASIC ELEMENTS OF A SCIENTIFIC PAPER
type of study design, brief description of study group/animals/test organisms/test materials
methods
BASIC ELEMENTS OF A SCIENTIFIC PAPER
highlights
results
BASIC ELEMENTS OF A SCIENTIFIC PAPER
based on the findings
conclusion
BASIC ELEMENTS OF A SCIENTIFIC PAPER
- what the study was all about and why it was done
- gives a background of the study/problem/disease state in question
- adequately state why the study was done (clearly stated objectives and significance of the study)
INTRODUCTION
BASIC ELEMENTS OF A SCIENTIFIC PAPER
- detailed methods employed
- research design and reason for using
- description of the study group and how these were chosen
- detailed laboratory measurements & procedures
- detailed description of measuring devices/analytic equipment
METHODOLOGY
BASIC ELEMENTS OF A SCIENTIFIC PAPER
- what was found
- presentation of findings, no discussion or evaluation
- use of tables, graphs, schemes, or pictures to clarify findings that are diffcult to describe with words
- data presented should be summarized
- statistical analysis are presented starting with a descriptive statistics
RESULTS
BASIC ELEMENTS OF A SCIENTIFIC PAPER
- what do the data mean?
- interpret findings from the study thru comparison or contrasts with findings from other studies
- limitations and strengths of the study should be discussed
DISCUSSION
BASIC ELEMENTS OF A SCIENTIFIC PAPER
- answer the objectives based on findings
- should be stated based on the results of the study or should be supported by the data
CONCLUSION
BASIC ELEMENTS OF A SCIENTIFIC PAPER
other contributors, assistants, funding agency
acknowledgement
BASIC ELEMENTS OF A SCIENTIFIC PAPER
list of publications used in the study
References / Bibliography
