Group Design

Dr. Sidra Majeed; PT

Assumption of group experimental Design
• Variability is intrinsic to human subjects, rather than
coming from sources external to the people involved.
• The myriad factors —age differences, intelligence,
motivation, health status, and so on.
• if an experimenter uses a large enough sample and the
sample is randomly drawn from the population and
randomly assigned to the groups in the research, all those
intrinsic factors will be balanced out between
experimental and control groups, and the only effects left
(aside from experimental errors) will be those of the
independent variable or treatment.
RANDOMIZED CONTROLLED TRIALS
• RCTs are prospective and experimental
• (1) the independent (treatment) variable is subject
to the controlled manipulation of the investigator
and
• (2) the dependent (measurement or outcome)
variables are collected under controlled conditions.
• The independent variable consists of at least two
levels, including a treatment group and comparison,
or control, group.
• RCT refers to random allocation
 RCT
• By definition then, all RCTs are experimental
designs. However, not all experimental designs
are RCTs, in that there are many non-random
ways of placing participants into groups.

• RCTs comparing body-weight–supported

treadmill training to traditional gait training
have been published, similar to phase III trials.
 Cautions About RCTs
• For example, if one wanted the strongest
possible evidence about whether cigarette
smoking causes lung cancer, one would design
and implement an RCT comparing a smoking
group to a non-smoking group.
 CON…

• practically impossible to obtain a true random

sample of a population.
• Hegde notes that, in random selection,
“All members of the defined population are
available and willing to participate in the
study.” (Not all population in clinic)
• All members of a population have an equal
chance of being selected for a study. (Ethical
consent not obtained)
 CON…

• In RCTs, patients are (perhaps) randomly

assigned to fixed treatment conditions.
However, intervention is individualized.
• There is no assumption that results of a group-
design experiment are generalizable to any
particular individual,
• Because results are based on averages and the
“average” person probably does not exist.
 SINGLE-FACTOR EXPERIMENTAL
DESIGNS
• In 1963, Campbell and Stanley published what
was to become a classic work on single-factor
experimental design:
• Experimental and Quasi-Experimental Designs
for Research.
• 16 different experimental designs
 Typology of experimental design

• Campbell and Stanley (1966) developed the typology

of design explored here

• R= Random allocation to group

• O= Observation or measurement
• C= Control Group
• E= Experimental group
• X= exposure of the group to the experimental variable
Pretest–Posttest Control-Group Design
• The design calls for at least two groups
randomly selected (as well as possible) from
the population of interest and randomly
assigned to one group or another
• Performance on the dependent variable(s) is
measured and, often, equivalence on the
dependent variable(s) is determined
statistically.
 Example
• Runeson and Haker used the classic design to study the effect of
iontophoresis with cortisone on the treatment of lateral epicondylitis, or
tennis elbow.
• They compared two groups: a treatment group that received cortisone
iontophoresis
• and a passive control group that received sham iontophoresis.
• They were treated four times over 2 weeks and were measured at the
conclusion of the treatment and at 3 and 6 months following the
completion of the treatment.
• Both groups improved during the study and follow-up period, and there
was no statistically significant difference in the response between the two
groups, leading the authors to question the use of cortisone iontophoresis
in the treatment of tennis elbow.
 CON…
• In clinical research, the pretest–posttest control group design is often altered slightly, as
follows:
R O X1 O
R O X2 O
when the researcher does not believe it is ethical to withhold treatment or when two treatments
for comparison. A control group receiving a standard treatment can be referred to as an active
control group.
• Pulvermuller and colleagues used a pretest–posttest control-group design with an
active control group in their study of constraint-induced therapy for chronic
aphasia after stroke. The treatment group received constraint-induced therapy
with intense practice over 10 days. The control group received conventional
therapy for aphasia over 4 weeks. Treatment showed significant improvement
in a number of communication variables compared with the conventional
group.
 Additional variation
• Include taking more than two measurements
and using more than two treatment groups.
The general notation for this design would be
as follows, with the appropriate number of
groups and measurement periods:
R O O X1 O O
ROO X2 O O
ROO OO
 Posttest-Only Control-Group Design

• Researchers use this design when they are not able to

take pretest measurements.
• judgments about the effect of the independent
variable on the dependent variable.
• Like the pretest–posttest control-group design, this
design is an RCT and a between-groups design. The
Campbell and Stanley10(p25) notation for this design
is as follows:
RXO
RO
 CON…
• Baty et al used this design to compare the effects of a
carbohydrate-protein supplement (CHO-PRO) versus a
placebo on resistance exercise performance of young,
healthy men.
• The study was double-blind. The 34 participants were
randomly assigned and asked to perform a set of eight
resistance exercises.
• Performance of the exercises did not vary significantly
between groups, although the researchers concluded that
the CHO-PRO inhibited muscle damage to a greater degree
than did the placebo based on posttreatment measures of
myoglobin and creatine kinase.
 Single-Group Pretest–Posttest Design

• The Campbell and Stanley notation for the

single group pretest–posttest design is as
follows:
OXO
• Unlike the above mentioned designs, the
single-group design is neither an RCT nor a
between-groups design.
 EXAMPLE
• In a pilot study, Novack et al examined the effects of an in-
home occupational therapy program on 20 children with
spastic hemiplegic cerebral palsy.
• Dependent variables were changes in the Goal Attainment
Scaling (GAS), the Pediatric Evaluation of Disability Inventory
(PEDI), and the Quality of Upper Extremity Skills Test
(QUEST).
• They also measured participation amount through a parent
self-report. They found that significant changes on the
published scales occurred after implementing the home
program but found no relationship between participation
amount and outcome using the same measures.
 Nonequivalent Control-Group Design

• Used when a nonrandom control group is available

for comparison.
• The Campbell and Stanley notation for this design
is as follows:
O XO
-----------
O O
• The dotted line between groups indicates that
participants were not randomly assigned to groups.
 Example
• Case-Smith’s study of the effectiveness of a school-based occupational
therapy intervention on handwriting.
• In this study, occupational therapists in five school districts identified
potential participants for the intervention group from among those who
had been referred to them for occupational therapy to improve
handwriting skills. Then, teachers in those same districts identified
potential participants for the comparison group from among students with
poor handwriting who had not been referred to occupational therapy.
• There were some differences between the two groups that probably
resulted from this nonrandom allocation to groups: several children in the
occupational therapy group but none in the comparison group were
receiving speech language therapy and physical therapy and higher
proportions of children in the occupational therapy group were diagnosed
with learning or developmental disabilities.
 Time Series Design

• Used to establish a baseline of measurements

before initiation of treatment to either a group or
an individual.
• When a comparison group is not available, it
becomes important to either establish the stability
of a measure before implementation of treatment
• The Campbell and Stanley notation for the time
series design is as follows:
OOOOXOOOO
 CON…
• Ulione used a time series approach to study the impact of a
health promotion and injury prevention program at a child
development center. Data on the upper respiratory illnesses,
diarrhea, and injuries of the children in the development
center were collected once a week for 4 weeks before and
after the health promotion program.
• The four measurements taken before and after the
intervention provide a fuller picture of the health status of the
children than would single pretest and posttest measures.
• Although the time series approach can be applied to group
designs, as it was in Ulione’s work, in rehabilitation research it
is commonly used with a single-subject approach
 Repeated Measures or Repeated
Treatment Designs
• Repeated measures designs are widely used in health science
research.
• The term repeated measures means that the same
participants are measured under all the levels of the
independent variable.
• In this each participant receives more than one actual
treatment. The repeated measures designs are also referred
to as with in subjects or within-group designs because the
effect of the independent variable is seen within participants
in a single group rather than between the groups. When the
order in which participants receive the interventions is
randomized, this design is considered an RCT with a cross-
over design.
 There are two basic strategies for selecting treatment
orders in a repeated measures design with several levels
of the independent variable.
 MULTIPLE-FACTOR EXPERIMENTAL
DESIGNS
• we wanted to conduct a study to determine the effects of different
rehabilitation programs on swallowing function after cerebral vascular
accident.
• start by selecting 60 patients for study and randomly assigning them to
one of the three groups (posture program, oral-motor program, and a
feeding cues program). The first independent variable would type of
treatment, or group.
• Then assume that two different therapists—perhaps a speech-language
pathologist and an occupational therapist—are going to provide the
treatments. A second independent variable, then, is therapist.
• a third question must also be asked in this design: Is one therapist more
effective with one type of treatment and the other therapist more
effective with another type of treatment? (interaction).
3 × 2 factorial design
 Completely Randomized Versus
Randomized-Block Designs
• The Treatment × Therapist
• example of a completely randomized design
• a randomized-block design is used, in which
one of the factors of interest is not
manipulable
• one of the independent variables is active
(manipulable); the other is very often an
attribute variable, such as age, or clinical status
• Participants would be placed into blocks based on
gender and then randomly assigned to treatments.
• This arrangement is also known as a mixed design and is
extremely common in rehabilitation research.
• Most often, the within-subjects factor is the
manipulable, active independent variable; all
participants receive all the levels of treatment. The
within-subjects factor is usually the groups in the
research, very often based on an attribute variable (e.g.,
typically developing versus hearing-impaired children).
 Mixed design
• A mixed, or split-plot, design contains a combination of between-subjects
and within-subject factors.