Experimental research allows researchers to test cause-and-effect relationships by manipulating independent variables and observing their effects on dependent variables. Key aspects of experimental research include identifying independent and dependent variables, using control groups, random assignment, and controlling for extraneous variables. Researchers must also consider issues of internal and external validity when designing and interpreting experiments. Common experimental designs include pre-experimental, true experimental, quasi-experimental, single-subject, and factorial designs. Proper data analysis and replication of results are important for validating experimental findings.
Jonas Ranstam MedicReS World Congress 2013MedicReS
Practical and statistical aspects of randomization
and blinding in clinical trials
Jonas Ranstam PhD
Department of Clinical Sciences
Lund University
Sweden
Jonas Ranstam MedicReS World Congress 2013MedicReS
Practical and statistical aspects of randomization
and blinding in clinical trials
Jonas Ranstam PhD
Department of Clinical Sciences
Lund University
Sweden
Experimental Epidemiology
1st Clinical trial
Basic steps in RCT
Randomization & its method
Manipulation/ Intervention
Types of RCT
Phases in Clinical trial
Hierarchy of epidemiological study
Critical appraisal is the process of carefully and systematically analyze the research paper to judge its trustworthiness, its value and relevance in a particular context. (Amanda Burls 2009)
A critical review must identify the strengths and limitations in a research paper and this should be carried out in a systematic manner.
The Critical Appraisal helps in developing the necessary skills to make sense of scientific evidence, based on validity, results and relevance.
Experimental Epidemiology
1st Clinical trial
Basic steps in RCT
Randomization & its method
Manipulation/ Intervention
Types of RCT
Phases in Clinical trial
Hierarchy of epidemiological study
Critical appraisal is the process of carefully and systematically analyze the research paper to judge its trustworthiness, its value and relevance in a particular context. (Amanda Burls 2009)
A critical review must identify the strengths and limitations in a research paper and this should be carried out in a systematic manner.
The Critical Appraisal helps in developing the necessary skills to make sense of scientific evidence, based on validity, results and relevance.
Steps in conducting a RCT
1. Drawing up a protocol
2. Selecting Reference & Experimental population
3. Randomization
4. Manipulation or Intervention
5. Follow up
6. Assessment of outcome
1. Drawing up a protocol
Aims and objectives of the study
Questions to be answered
Criteria for the selection of study and control groups
Size of the sample & allocation of subjects in both groups
Treatment to be applied - when, where, how
Standardization of working procedures and
Schedules as well as responsibilities of persons involved in the trial up to the stage of evaluation of outcome of the study.
2. Selecting Reference and Experimental Populations
Reference or target population - Population to which the findings of the trial, if found successful, are expected to be applicable (Eg: drugs, vaccines, etc.)
Experimental or Study population
Derived from the Reference population
Has same characteristics as the Reference population
Actual population that participates in the experimental study
Must give informed consent - Should be qualified or eligible for the trial
3. Randomization
Heart of the control trial
Procedure:
Participants are allocated into study and control groups
Eliminates bias and allows comparability
By random allocation every individual gets an equal chance for being allocated in to either groups.
4. Manipulation/ Intervention
Having formed the study and control group, the next step is to intervene or manipulate the study (experimental) group by deliberate application or withdrawal or reduction of a suspected causal factor
Eg: Drug, Vaccine, Dietary component, a habit
5. Follow up
Implies examination of the experimental and control group subjects at defined intervals of time in a standard manner, with equal intensity, under the same given circumstances in the same time frame till final assessment of outcome.
Attrition:
Inevitable losses to follow up (death, migration, loss of interest)
6. Assessment
a. Positive results:
Reduced incidence or severity of disease
Reduced cost to health service
Appropriate outcome in the study
b. Negative results:
Increased severity or frequency of side effects
Complications
Deaths
BIAS:
Any systematic error in the determination of association and outcome.
Bias may arise from errors of assessment of outcome due to human element
Subjective bias
Observer bias
Evaluation bias
1. Subjective Bias:
Participants, subjectively feel better or report improvement if they knew they were receiving a new form of treatment. This is known as “Subject variation”.
2. Observer Bias:
Investigator measuring the outcome of a therapeutic trial may be influenced if he knows beforehand the particular procedure or therapy to which the patient has been subjected.
3. Evaluation Bias:
Investigator may subconsciously give a favorable report of the outcome of the trial.
Blinding:
1. Single Blind Trial: Participant
2. Double Blind: Partcipant + Investigator
3. Triple Blind: Participant + Investigator + Data Analyzer
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International Cancer Survivors Day is celebrated during June, placing the spotlight not only on cancer survivors, but also their caregivers.
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This conference will delve into the intricate intersections between mental health, legal frameworks, and the prison system in Bolivia. It aims to provide a comprehensive overview of the current challenges faced by mental health professionals working within the legislative and correctional landscapes. Topics of discussion will include the prevalence and impact of mental health issues among the incarcerated population, the effectiveness of existing mental health policies and legislation, and potential reforms to enhance the mental health support system within prisons.
DECODING THE RISKS - ALCOHOL, TOBACCO & DRUGS.pdfDr Rachana Gujar
Introduction: Substance use education is crucial due to its prevalence and societal impact.
Alcohol Use: Immediate and long-term risks include impaired judgment, health issues, and social consequences.
Tobacco Use: Immediate effects include increased heart rate, while long-term risks encompass cancer and heart disease.
Drug Use: Risks vary depending on the drug type, including health and psychological implications.
Prevention Strategies: Education, healthy coping mechanisms, community support, and policies are vital in preventing substance use.
Harm Reduction Strategies: Safe use practices, medication-assisted treatment, and naloxone availability aim to reduce harm.
Seeking Help for Addiction: Recognizing signs, available treatments, support systems, and resources are essential for recovery.
Personal Stories: Real stories of recovery emphasize hope and resilience.
Interactive Q&A: Engage the audience and encourage discussion.
Conclusion: Recap key points and emphasize the importance of awareness, prevention, and seeking help.
Resources: Provide contact information and links for further support.
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The global veterinary diagnostics market size reached US$ 6.6 Billion in 2023. Looking forward, IMARC Group expects the market to reach US$ 12.6 Billion by 2032, exhibiting a growth rate (CAGR) of 7.3% during 2024-2032.
More Info:- https://www.imarcgroup.com/veterinary-diagnostics-market
COVID-19 PCR tests remain a critical component of safe and responsible travel in 2024. They ensure compliance with international travel regulations, help detect and control the spread of new variants, protect vulnerable populations, and provide peace of mind. As we continue to navigate the complexities of global travel during the pandemic, PCR testing stands as a key measure to keep everyone safe and healthy. Whether you are planning a business trip, a family vacation, or an international adventure, incorporating PCR testing into your travel plans is a prudent and necessary step. Visit us at https://www.globaltravelclinics.com/
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TEST BANK For Accounting Information Systems, 3rd Edition by Vernon Richardson, Verified Chapters 1 - 18, Complete Newest Version
2. Experimental Research vs. Other Methods
2
❖
❖
Cantest for cause/effect relationships
Manipulation of independent variable(s)
Simply put:
Decisions about the forms and values of the IV, as
well as about which group receives which treatment
are at the solediscretion of the researcher
3. Variables in Experimental Research
3
❖ IndependentVariable:
❖
❖
Experimental Variable, Cause, or Treatment
The activity or characteristic the researcher believes
makes a difference
❖ DependentVariable:
❖
❖
❖
❖
Criterion Variable, Effect, or Posttest
Outcome of the study
Difference in group(s) that occurs as a result of the
manipulation of the IV
Only constraint: must represent a measurable
outcome
4. Characteristics of Experimental Research
4
❖ Demanding & Productive, but...
❖ Produce the soundest evidence of hypothesized cause-effect
relationships
❖ Difference between Correlational & Experimental
Research:
❖
❖ Correlational can be used to predict a specific score for a
specific individual
Experimental predicts more global results*
5. Steps in Experimental Research Study
5
1. Select and define problem.
2.Select subjects and [measurement] instruments.
3.Select design.
4.Execute procedures.
5.Analyze data.
6.Formulate conclusions.
6. Role of the Researcher
6
❖
❖
❖
❖
Forms or selects groups
Decides what will happen to each group
Attempts to control all variables and factors
Observes and measures effect on the groups
Every effort is made to make sure the 2groups have
equivalent variables—except for the independent variable.
7. Two Groups
7
❖
❖
Experimental Group
❖ Receives the new treatment being investigated
Control Group
❖
❖
Receives a different treatment; or
Receives same treatment as usual (i.e. is left alone)
The Control Group is needed in order to identify/measure any
differences observed as a result of the differing treatments
8. Potential Issues in Experimental Research
8
❖ Experimental treatment not given adequate time to
take effect
❖ Experimental group should be exposed to treatment for a long
enough period of time for the treatment to work
❖ Treatments received by the 2groups are not
“different enough”
❖ No difference between the groups will be found if the
experimental treatment and the control treatment are too
similar
9. Experimental Validity
9
❖ Experiments are considered valid if:
❖ The results obtained are only due to the manipulation
of the independent variable
❖ Two conditions must be met:
❖ Experiment has internal validity
❖ Experiment has external validity
10. Internal Validity
10
❖ Observed differences on the dependent variable are the direct result of the
researcher’s manipulation of the independent variable.
❖ Campbell & Stanley (1971) identified 8threats to internal validity:
❖
❖
❖
❖
❖
❖
❖
❖
History - becomes more likely the longer a study is; caused by external events.
Maturation - physical/mental changes occurring in subjects over time; more likely to occur when study is extended over a
long period of time.
Testing (pretest sensitization) - result of higher scores on a posttest due to participants having taken a pretest; unlike
above, more likely to occur when there are short intervals between testing.
Instrumentation - lack of consistency between measuring instruments; data collection leads to unreliable/invalid results.
Statistical Regression - tendency for some scores to move towards the mean score; participants who score the highest and
lowest on a pretest are more likely to score lower and higher (respectively) on a posttest.
Differential Selection of Subjects - differences already present between two pre-formed groups could account for
differences in posttest results.
Mortality (attrition) - occurs most often in long-term studies; refers to participants who drop out of a group potentially
sharing some characteristic that affects the significance of the study.*
Selection-Maturation Interaction, Etc. - if pre-formed groups are used, one group may be at an (dis)advantage due to
factors of maturation; the “etc.” refers to the fact that selection can also interact in this way with other factors such as
history, testing, instrumentation, etc.
11. External Validity
11
❖ Results of the experiment are generalizable to groups and environments outside of the experiment;
results of the study can be reconfirmed with other groups, in other settings, and at other times (if
the conditions are similar to those present in the experiment).
❖ Bracht & Glass (1968)identified 6 threats to external validity:
❖ Pretest-Treatment Interaction - participants react differently to a treatment because they have been pretested; pretests may alert
participants to the make-up of the treatment; therefore, results can only be generalized to other pretested groups.
❖ Multiple-Treatment Interference - the same participants receive the same treatment in succession; effects are carried-over from the first
treatment making it hard to determine the effectiveness of the second treatment.
❖ Selection-Treatment Interaction - occurs when participants are not randomly selected for the treatments they receive; can occur when
participants are a pre-formed group or an individual; limits the generalizability of the results.
❖ Specificity of Variables - does not depend on the experimental design chosen; threatens validity when a study is conducted:
❖
❖
❖
❖
❖
with a specific kind of subject;
based on a particular definition of the independent variable;
using specific measuring instruments;
at a specific time; and
under a specific set of circumstances.
❖ Experimenter Effects - experimenter unintentionally affects the implementation of the study’s procedures, the behavior of the participants,
or the assessment of participant behavior, thereby affecting the results of the study.
❖ Reactive Arrangements - factors associated with how a study is conducted effectively influence the feelings and attitudes of the
participants; affects generalizability of the results.
12. Extraneous Variables
12
❖ The control of extraneous variables is vital to the success of
an experiment.
❖ Extraneous variables can be controlled through:
❖
❖
❖
❖
❖ Randomization - subjects should be randomly selected for participation and randomly assigned to groups; randomizing
selection should be attempted whenever possible
Matching - researcher pairs up participants with matching (similar) scores or characteristics (gender, IQ, location), then
randomly assigns each participant to a different group than their counterpart; this ensures that the pair with matching
IQ scores are not in the same group
Comparing homogenous groups or subgroups - group participants according to their similarity/fit into a variable
subgroup (IQ, SAT score); randomly assign half of the subgroup to the experimental group, and the other half of the
subgroup to the control group
Using subjects as their own controls - the same participants get both treatments (one treatment at a time); controls for
participant differences; can result (negatively) in carry-over effects between the treatments
Analysis of covariance - statistically equate randomly formed groups on a particular variable; can be used to adjust for
large differences in pretest scores between groups
13. Group Designs
13
❖ Two classes of experimental designs:
❖ Single-Variable: one independent variable; IV is manipulated
❖ Three types—
❖
❖
❖
Pre-experimental
True experimental*
Quasi-experimental
❖ Factorial: two or more independent variables; at least one IV
is manipulated
❖
❖
❖ Elaborate on single-variable designs;
Investigates each variable independently and in interaction
with other variables;
Sky’s the limit**
14. Pre-Experimental Designs
14
❖ One-Shot Case Study —
❖ One group exposed to one treatment then given posttest
❖
❖
Don’t know level of group knowledge before the treatment!
Sources of invalidity are not controlled!
❖ One-Group Pretest-Posttest Design —
❖ One group pretested, exposed to one treatment, then posttested
❖
❖
Still a number of factors affecting validity that are not controlled!
Other factors may influence any differences observed between the pretest and posttest
❖ Static-Group Comparison —
❖ At least two groups; first receives new treatment; second receives usual
treatment; both posttested
❖
❖
Purpose of control group is to show how the experimental (first) group would have performed had
they not received the new treatment
Effective only to the degree that the two groups are equal to each other
15. True Experimental Designs
15
❖ Pretest-Posttest Control Group Design —
❖ At least two randomly-assigned groups; both pretested for dependent variable;
one group then receives the new treatment; then both groups are posttested.
❖
❖
Internal invalidity fully controlled by: random assignment, pretesting, & inclusion of a control group
Potential risk of interaction between the pretest and the treatment*
❖ Posttest-Only Control Group Design —
❖ Same as pretest-posttest design, except there is no pretest
❖
❖
Subjects randomly assigned; exposed to independent variable; then posttested
Mortality is not controlled for (no pretest), but may not be a problem anyway
❖ Solomon Four-Group Design —
❖ Random assignment of participants to one of four groups
❖
❖
❖
❖
Two groups are pretested; two groups are not pretested
One pretested group & one unpretested group receive the experimental treatment
All four groups are posttested
Combination of the two designs (above) - eliminates both sources of internal invalidity!
16. Quasi-Experimental Designs
16
❖ Nonequivalent Control Group Design —
❖ Two or more existing groups pretested; administered treatment; and posttested.
❖
❖
Participants’ assignment to groups is not random; assignment of treatments to groups is random
Invalidity sources include: regression, selection-treatment interactions (maturation, history, and testing)
❖ Time-Series Design —
❖ One group repeatedly pretested; administered treatment; repeatedly posttested.
❖
❖
Elaboration of the one-group pretest-posttest design; involves testing (pre- and post-) more than once
Advantage lies in confidence gained through significant improvement of group scores between pretests and posttests
❖ Counterbalanced Designs —
❖ All groups received all treatments; each group receives treatment in a different
order than others.
❖
❖
❖
❖
Any number of groups can be involved; limited only by the number of treatments; # of groups =# of treatments
Order of each groups’ receipt of treatment is determined randomly; each group is posttested following each treatment
Pretest usually not possible and/or feasible; often used on existing groups
Weakness lies in potential for multiple-treatment interference; thus, should only be used when this is not a concern
17. Factorial Designs
17
❖
❖
Two or more independent variables; at least one is
manipulated by researcher
Term “factorial” comes from the use of multiple variables
with multiple levels
❖
❖
2x 2factorial design*
Can get very complicated (2 x 3, 3x 2, etc.)!
❖
❖
Often employed after using a single-variable design;
❖ “Variables do not operate in isolation”
Studies how variables behave at different levels**
18. Single-Subject Experimental Designs
18
❖
❖
❖
Also referred to as “single-case experimental designs”
Used when sample size =1; or for multiple individuals
considered as 1 group
❖ Variation of the time-series design
Typically used asastudy of behavioral change in an
individual
❖ Participant is own control; exposed to both nontreatment &
treatment phases;
❖ Individual’s performance measured repeatedly during all phases
❖ Nontreatment phase =A; Treatment phase =B
19. Validity in Single-Subject Experiments
19
❖ ExternalValidity
❖
❖
Frequent criticism due to lack of generalizability
Can be counteracted through replication
❖ InternalValidity
❖ Repeated and Reliable Measurement
❖ If results are to be trusted, treatment must follow exact same procedures every time
❖ Baseline Stability
❖ Provides basis for assessing the effectiveness of the treatment; must do enough
baseline measurements to establish a pattern*
❖ The Single Variable Rule
❖ Only one variable should be manipulated at any one time!
20. Types of Single-Subject Designs
20
❖ A-B-AWithdrawal Designs --
❖ The A-B* Design
❖
❖
Establishment of baseline stability; treatment given
Improvement during treatment =effectiveness of treatment
❖ The A-B-A Design
❖
❖
Adds a second baseline measurement to the A-B design
Improves validity IF behavior improves during the B phase, and subsequently
deteriorates during the second A phase
❖ The A-B-A-B Design
❖
❖
❖
Adds a second treatment phase to the A-B-A design
Could add strength to experiment IF behavior improves during treatment twice!
Eliminates ethical concerns from A-B-A design (ending with participant not
receiving potentially effective treatment)
21. Types of Single-Subject Designs (cont’d)
21
❖ Multiple-Baseline Designs
❖
❖
❖
Alternative to the A-B design
Used when unable to withdraw the treatment, or when it would be unethical to do so
Three basic types: across behaviors, across subjects, and across settings*
❖ AlternatingTreatments Design
❖
❖
❖
Only valid design for assessing effectiveness of 2+treatments in a single-subject
context
Rapid alternation of treatments for a single subject
Treatments are alternated randomly
❖
❖
❖
Notice: no withdrawal phase, no baseline phase.
Allows for the study of multiple treatments quickly and efficiently
Could introduce multiple-treatment interference
22. Data Analysis/Interpretation
22
❖ Typically involves graphically-represented results
❖ Design must be evaluated for adequacy; then
treatment effectiveness is assessed
❖ Clinical Significance vs. Statistical Significance
❖ t and F tests can be used to test for statistical
significance
23. Replicating Results
23
❖ As results are replicated, confidence in the procedures used grows
❖ Direct replication
❖
❖
Replication by the same investigator in the same setting
[Note] the same or different participants may be used
❖
❖
Simultaneous replication
❖ Same problem; same location; and same time
Systematic replication
❖ Direct replication with different investigators, behaviors, or settings
❖ Clinical replication
❖
❖
Treatment package with 2+treatments.*
Designed for participants with complex behavior disorders
24. Example of Experimental Research
24
❖ Brain-Computer Interface Project
❖ University of Illinois at Urbana-Champaign
❖
❖
❖
Collected brain signals through EEG
Used one group of 9 individuals
Allowed “practice” session before testing, but no
pretest was conducted
25. Infamous Cases of Unethical Research
❖ Tuskegee Syphilis Study (1932-1972)
❖ Nearly 400 African-American men were infected with syphilis
❖ Study conducted by Public Health Service
❖ Led to the 1979 Belmont Report (modern foundation for ethical research of
human subjects)
❖ Milgram Obedience toAuthority Study (began 1961;
made public 1963)
❖ Residents of New Haven, CT recruited to participate in astudy of “memory and
learning”
❖ Participants asked to inflict electric shocks in increasing voltages based on
“learner’s” incorrect answers (maximum voltage of 450 volts)
❖ Study conducted at Yale University; intended to determine whether ordinary
people would follow orders they considered immoral (i.e. Nazi Holocaust/Adolf
Eichmann)
❖ Stanford Prison Experiment (1971)
❖
❖
❖
24 students chosen as “prisoners,” while 9 “guards” were assigned to 3shifts
Shut down after 6 days (originally intended to take 2weeks) due to a
deterioration of the experiment’s conditions and structure
Both prisoners and guards adapted to their given roles--guards becoming
authoritarian and prisoners becoming passive
25
26. References
26
Gay, L. R. (1996). Educational research : competencies for analysis and application /L.R. Gay (5th
ed.): Englewood Cliffs, N.J. : Merrill, 1996.
Milgram experiment. (2011, February 7). In Wikipedia, The Free Encyclopedia. Retrieved from http://
en.wikipedia.org/w/index.php?title=Milgram_experiment&oldid=412574744.
Stanford prison experiment. (2011, February 11). In Wikipedia, The Free Encyclopedia. Retrieved
from http://en.wikipedia.org/w/index.php?title=Stanford_prison_experiment&oldid=413232983.
Omar, C., Akce, A., Johnson, M., Bretl, T., Rui, M., Maclin, E. (2011).A Feedback Information-
Theoretic Approach to the Design of Brain-Computer Interfaces. [Article]. International Journal of
Human-Computer Interaction, 27(1), 5-23. doi: 10.1080/10447318.2011.535749.
Tuskegee syphilis experiment. (2011, February 3). In Wikipedia, The Free Encyclopedia. Retrieved
from http://en.wikipedia.org/w/index.php?title=Tuskegee_syphilis_experiment&oldid=411791432.