POWERPOINTS TO ACCOMPANY

Research for Advanced Practice Nurses:

From Evidence to Practice, Fourth Edition
Beth A. Staffileno, PhD, FAHA
Marcia Pencak Murphy, DNP, ANP, FAHA, FPCNA
Susan Weber Buchholz, PhD, RN, FAANP, FAAN

Chapter 9: Quantitative Designs for Practice Scholarship

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 INTRODUCTION

• In a quantitative approach, research questions are explored using numerical data for analysis and
interpretation.
• Quantitative data provide an objective means to answer study questions and test hypotheses.
• Quantitative methods involve the following:
o Determining the purpose of the research that can be addressed with a measurable question
o Determining an appropriate study design
o Determining the study implementation (involves carrying out study procedures in a particular setting,
collecting study data, and data management)
o Determining how to perform a statistical analysis of data (enables the investigator to determine
whether findings were likely to occur by chance alone rather than because of the proposed
relationship between variables or the effect of an intervention)

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 STUDY VARIABLES

• Every quantitative research study begins with identification of a topic area that can be addressed with
a measurable study question.
• A clear question forms the foundation for study design, identifies the population that is being studied,
and identifies key variables of interest about that population.
• Studying different variables can help determine relationships and/or differences in a population.
• The research question can be easily transformed to a hypothesis, which predicts the relationship
between variables. It is also important to determine the null hypothesis.
• An independent variable is what the researcher manipulates and is the presumed cause in the study.
• A dependent variable is the presumed effect in the study and may also be termed the outcome
variable.

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 STUDY VARIABLES (CONT’D)

• A mediating variable is an intervening variable that affects the interaction between the independent
and dependent variables; it facilitates, augments, or reduces the effects of the independent variable.
• The moderating variable is a factor that affects the relationship between the independent and
dependent variables.
• Statistical analyses are used to analyze the effects of mediators and moderators on an intervention.
• Extraneous variables represent a condition that is not part of the study design and that the
researchers are not interested in measuring, but can still affect the outcome of the study.
• Confounding variables occur if extraneous variables are recognized prior to the study, but the
researchers are unable to control for them, or if these variables are not recognized until after the study
has been initiated.
• Randomization is useful in limiting the impact of confounding variables.
• Statistical techniques, such as analysis of covariance, can be used to account for the effect of
variables.
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 MEASUREMENT PROPERTIES

• Measurement is the process of assigning numbers to variables.

• Methods used for measurement are referred to as instrumentation.
• Data can be obtained through methods such as
o physical measurements
o biomedical data
o use of questionnaires
o use of patient rating scales, diaries, or responses in structured interviews

• In planning research, the objective is to select measurement methods that provide valid and reliable
results that are also sensitive and specific.
• Validity describes the degree to which the instrument used is truly measuring what the researcher
intends to measure.

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 MEASUREMENT PROPERTIES (CONT’D)
• Construct validity assesses how adequate an instrument is in measuring the main construct.
o Translational validity assesses how well the construct is translated and includes face validity and
content validity.
 Face validity is based on looking at an instrument and determining if it measures what it is
supposed to be measuring according to an expert in the field.
 Content validity assesses if the content adequately represents the “universe” of what is being
measured.
o Criterion validity assesses the correlation between what the instrument measures and other criteria.

 Methods that can be used to assess criterion validity include concurrent validity, predictive validity,
convergent validity, and discriminant validity.
 With concurrent validity, a researcher assesses the correlation between the instrument and a
criterion that is related.
 With predictive validity, a researcher assesses how well the scores predict a score on another
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future criterion.
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 MEASUREMENT PROPERTIES (CONT’D)

o Criterion validity, cont’d

 With convergent validity, a researcher uses different methods to measure the same attribute to
assess if they obtain the same results.
 With discriminant validity, a researcher assesses how easy or difficult it is to differentiate
between the construct being measured and a similar construct.
• Statistical conclusion validity assesses the accuracy of conclusions made about the relationships
and differences among variables based on the statistical evidence.
• Internal validity assesses if the independent variable actually was the cause of the observed effect in
the dependent variable.
• External validity evaluates to what degree the results of the study can be generalized to a specific
population.

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 MEASUREMENT PROPERTIES (CONT’D)

• Reliability assesses measurement consistency.

o It evaluates how dependable an instrument is in the measurement of a variable.
o If a measure is reliable, then it will report the same value for the same item being measured
successively.
o The type of reliability that matters most is related to the study design.
 For example, in a repeated-measures design, test–retest reliability is important.
 In a study plan in which multiple observers collect data, it is important to ensure that different
people using the same instrument in the same observation would obtain the same result, meaning
the tool has good inter-rater reliability.
o Stability assesses if the instrument measures the same results repeatedly.
 Test–retest reliability refers to whether or not the same person using the instrument would get the
same result with multiple uses.
 Parallel forms assess the consistency of the results of two tests that are constructed both in the
same way and with the same content domain. 8

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 MEASUREMENT PROPERTIES (CONT’D)

• Reliability, cont’d
o Internal consistency is applicable to instruments such as questionnaires and multiple item rating
scales. It shows the degree to which items on an instrument actually measure a single thing.
 If internal consistency is high, it suggests that the set of questionnaire items is measuring the
same concept or variable.
 If internal consistency is low, it suggests that individual items within a questionnaire may be
measuring different concepts.
 Although interpretation of internal consistency values can be somewhat arbitrary, it can be said
that higher values reflect greater reliability.
 Cronbach’s alpha is a correlation coefficient that estimates internal consistency. The higher the
value for alpha, the greater the internal consistency.
 Split-half assesses for consistency when a set is divided into two sets, administered separately,
and then compared.
 Kuder-Richardson assesses inter-item consistency by examining the adequacy of content
sampling and heterogeneity of the domain that is being sampled. 9

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 MEASUREMENT PROPERTIES (CONT’D)

• Reliability, cont’d
o Equivalence assesses how different observers rate an instrument.
 Inter-rater reliability is the degree to which different observers would achieve the same result
using the instrument.
 Kappa statistic assesses an index that compares the agreement against that which a researcher
might expect by chance. The value of kappa can be interpreted as the proportion of agreement in
results among raters that did not occur by chance alone.
 Intraclass correlation assesses consistency for a data set when there is more than one group
present.
• Sensitivity is defined as the number of true positive decisions divided by the number of actual positive
cases (the true positives plus the false negatives).
o Indicates the ability to identify positive results and the degree to which a measurement method is
responsive to changes in the variable of interest
o Also refers to the magnitude of a change that a measure will detect
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o The more sensitive a measure, the better it will reflect small changes and detect positive findings.
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 MEASUREMENT PROPERTIES (CONT’D)

• Specificity is the degree to which a result is indicative of a single characteristic and can accurately
detect negative results.
o Mathematically, specificity is the number of true negative decisions divided by the number of actual
negative cases (the true negatives plus the false positives).
o In clinical settings, a receiver operator curve (ROC) is often used to display sensitivity and
specificity.
• Feasibility of a measurement may include the following considerations:
o Assess the actual number of questions, including the length of the questions, to determine if there is
undue participant burden in answering questions.
o Assess the types of questions that are asked (e.g., multiple choice or open-ended) to determine if
the type of data received will be useful and meaningful in the analysis.
o Assess if the participant is able to complete the questionnaire or if someone else is required to
complete it, such as the researcher or a family member.
o Consider ease of administration and scoring, availability of the instrument, and potential costs
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associated with using the instrument.
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 MEASUREMENT PROPERTIES (CONT’D)

• Patient-reported outcomes (PROs) are patients’ direct report of their own condition, behavior, or
experience, without interpretation by a clinician or someone else.
o There are four key PRO domains, which include health-related quality of life, symptoms and
symptom burden that are experienced, how people experience care, and specific health
behaviors.
o These domains are measured by various tools that assess how a patient reports physical, mental,
and social well-being.
o A PROM is the instrument, tool, and/or single-item measure that is used to assess the outcome.
o PRO-PM is the PRO-based performance measure.
o In appraising research for application in the clinical setting, the quality of measurement methods
contributes to the confidence in overall results.

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 UNDERSTANDING DATA

• Data are the discrete values that result from measurement of study variables.
• Quantitative data are one of four types in terms of numerical scale: nominal, ordinal, interval, or ratio.
• These scales indicate a hierarchical structure, where the ratio scale is the highest scale level.
• Nominal scale data (lowest scale level) assign a “name” to each observation. Examples of nominal
scale variables encountered in the clinical setting include
o gender
o diagnosis-related group (DRG) designation
o diagnosis codes
o procedure codes
• Ordinal scales provide numerical data that have an “order.”
o The most common examples of ordinal scale data are Likert-type scales.
o Results from typical patient satisfaction questionnaires used in the clinical setting are examples of
ordinal scale data. 13

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 UNDERSTANDING DATA (CONT’D)

• Interval scales provide data in which distances on the numerical scale are equal.
o Interval scales refer to equal distances, not a mathematical relationship.
o Patient ratings on a standard numerical pain symptom distress scale and patient severity scoring
systems are examples of interval scales.
• Ratio scales (highest scale level) provide the same information as interval scales but also have an
absolute zero point.
o Mathematically, on a ratio scale, “20” is exactly twice “10,” and “30” is exactly three times “10.”
o Volume, length, weight, and time are examples of ratio scales.
• The higher the scale level, the broader the range of statistical procedures that can be used.
o The scale of measurement determines the need for nonparametric or parametric statistics.
o Nonparametric statistics are appropriate when dealing with nominal and ordinal data.
o Because the sampling distribution of means should produce a normal curve, interval and ratio scale
data can be analyzed with parametric statistical procedures.
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 SAMPLING

• Quantitative research is designed to control, reduce, or account for factors that can affect the
dependent variable. This can be done by
o establishing study sample inclusion and exclusion criteria, including measurement and analysis of
potential confounding variables
o overall study design to reduce threats to validity
• To select participants for their research, researchers may use simple randomization, where, for
example, participants can be selected using a random number table.
• Systematic sampling chooses every Kth case from a list of individuals within a population.
• Stratified sampling involves subdividing a population into homogeneous groups in respect to a
specific characteristic; from that group, participants are randomly selected.
• With primary cluster sampling, an inclusive unit of a population is determined, and a sample of those
units is then randomly selected.
• Sampling decisions can introduce bias into the study because the characteristics of patients included
can influence results.
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 STUDY DESIGN

• The study design is the structure of the research that defines the timing of observations and
interventions and strategies used to ensure objectivity.
• Study designs generally fall into one of three broad categories:
o With a nonexperimental design, the researcher is observing and measuring what is occurring for
participants without changing or controlling their situation.
o With a quasi-experimental design, a researcher manipulates an independent variable, but
cannot or does not use random assignment.
o With an experimental design, the researcher delivers an intervention and also uses
randomization in the assignment of participants to different groups.

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 NONEXPERIMENTAL DESIGNS

• In nonexperimental designs, the researcher does not intervene in manipulating the independent variable
for participants.
• Descriptive designs are used in studies where the researcher seeks to observe and describe what is
occurring within a sample from a population.
o Descriptive studies provide information about commonalities and differences within a defined group of
patients.
o These studies are used to identify the incidence or prevalence of conditions, describe a phenomenon,
or evaluate relationships among variables explored.
o In a cross-sectional design, data are collected at one specific point in time.
o In a retrospective design, information is collected from prior participant records or other preexisting
sources of data.
o In a prospective design, information is collected after the study starts.
o In a longitudinal design, data collection also occurs at time points in the future.

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 NONEXPERIMENTAL DESIGNS (CONT’D)

• Correlational designs are used to evaluate relationships or associations among variables.

• Observational designs are used in studies where the outcomes of interest are analyzed between
groups of patients that received different interventions.
o Interventions are not controlled, and patients may not be specifically sampled or assigned to
treatments.
o Patients, interventions, and results are described, and statistical analysis of data is used to
determine differences in outcomes.
o Cohort designs involve a group or groups of patients that have one or more common defined
characteristics; may be prospective or retrospective.
o Case-control designs examine outcomes from a group of patients who are exposed to an
intervention or are identified by an outcome of interest.
 This group is compared to a group of patients from the same source population who are not
exposed or do not have the same outcome.
 In a matched case-control study, study patients are individually matched with patients who
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have the same characteristics that may influence outcomes (e.g., disease, age, gender.)
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 QUASI-EXPERIMENTAL STUDIES

• Quasi-experimental designs can be constructed with single or multiple groups, and they may involve
pretest and posttest or posttest-only measurement.
• With a one-group pretest–posttest design, measurement of the dependent variable is done prior to
and then again after an intervention in the same subject or group.
o Changes in the dependent variable from pre- to post-intervention in each subject are compared.
o The difference between pre- and post-intervention measurement is analyzed to evaluate the impact
of the intervention.
• With a nonequivalent control group, posttest-only design, the intervention is provided, and the
dependent variable is measured only after the intervention.
• With a nonequivalent control group, pretest–posttest design, participants are assigned to study
groups by the researcher or by participant self-selection of the group in which they want to participate.
o A key limitation is that patients in the intervention or control groups may have different
characteristics that influence the outcome.
o This can be addressed to some extent in analysis by examination of the differences between the
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groups at the onset of the study.
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 EXPERIMENTAL DESIGNS

• Experimental designs allow researchers to examine a cause-and-effect relationship between the

independent and dependent variables.
• Participants are randomly assigned to a treatment or control group.
• Random assignment of participants in a randomized controlled design is the generally accepted way to
attempt to spread the effect of intervening and extraneous variables across study groups by chance
alone.
• Without random assignment, there is a potential for selection bias, resulting in selection of particular
types of patients to receive particular treatments.
• The basic pretest‒posttest design is used when change is being assessed.
o Participants are measured before and after delivery of an intervention and are assigned to either a
group that receives the intervention or a control group.
o This simple design allows the researcher to assess differences in both groups.
o This is a good design to use when usual care is adequate, but the researcher wants to test an
intervention that is hypothesized to be more effective than usual care.
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 EXPERIMENTAL DESIGNS (CONT’D)

• In a placebo-control trial, individuals in the control group receive an inactive treatment that appears
exactly like the intervention being tested.
• In an active-control trial, the control group receives a different intervention for the same problem,
and outcomes between the two groups are compared.
o Active controls may be a current standard treatment or “usual care” for the problem or a different
experimental intervention.
o Designs with active control conditions may be aimed at testing a new intervention or aimed at
comparing the effects of alternate treatments.
• Attentional control should be considered in studies that involve examination of psychosocial,
educational, and supportive types of interventions.
o For many patient outcomes, it can be expected that providing additional attention alone to the
patient can result in the patient feeling better.
o For valid comparison, the control group should be given similar time and attention as the
experimental group.
o Researchers can provide “neutral” time and attention to patients as a control condition. 21

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 MIXED METHODS

• Quantitative methods can be used alone or in combination with qualitative techniques for a mixed
methods approach.
• In a mixed methods study design, qualitative results are used to provide additional depth and context
to research findings.
• Qualitative and quantitative results can be triangulated to demonstrate whether or not findings from
both methods converge to support each other.

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 OTHER DESIGN CONCEPTS

Longitudinal Designs
• Longitudinal designs involve some duration of follow-up after an intervention to determine longer-term
effects over time.
Repeated-Measures Design
• Repeated-measures design refers to measurement of variables multiple times.
• This approach can be used within any type of descriptive or interventional research.
• Measurement of dependent variables at multiple points in time enables evaluation of trends and timing of
effects.
Adaptive Designs
• An adaptive design uses accumulating study findings to modify aspects of the study as it continues.
• Study modifications can include changes in randomization procedures, sample size re-estimation, and
adaptation of the intervention.

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 SOURCES OF BIAS IN QUANTITATIVE METHODS

• Bias includes any aspect of a study that produces systematic error in regard to the study findings.
• Bias can cause results that are inaccurate and distorted, and it can occur knowingly or unknowingly.
• When designing the study, the researcher needs to consider potential biases that can occur with the
researcher, measures, participant, and the intervention.
• Standardize how measurements are delivered. Examples include:
o With a measure that requires a research team to rate a variable, ensure the process is the same
with each participant.
o When using an objective measure, ensure that the instrument is calibrated.
• Consider how participants are recruited for a study so that all potential participants have an equal
opportunity to be enrolled.
• Measures need to be put in place to analyze differences between the intervention group and control
group and between those individuals who participate fully and those who drop out.

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 THREATS TO INTERNAL AND EXTERNAL VALIDITY

• Validity is the degree of confidence that changes seen in a dependent variable are the result of the
independent variable studied rather than some unknown extraneous variables.
• In purely descriptive studies, internal validity refers to the accuracy and quality of the study.
• In studies to evaluate effects of interventions, several specific threats to internal and external validity
have been described.
Internal Threats to Validity
• History refers to an event that occurs during the point of measurement of pretest to posttest because
of something other than the intervention and intervening or mediating variables.
o This threat involves an event that has an effect on what is being observed, the dependent variable.
o It is more common with longitudinal designs than those in which data are collected over shorter time
periods.

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 THREATS TO INTERNAL AND EXTERNAL VALIDITY (CONT’D)

Internal Threats to Validity (cont’d)

• Maturation results in natural changes over time as subjects change.
o This type of threat is associated with longitudinal designs, particularly those that involve children or
individuals with diseases that naturally progress over time.
o Analysis of potential covariates to illuminate maturation effects can be helpful.
• Testing can be an issue when measurement methods involve repeated use of the same patient
questionnaires, testing, and self-report measures.
o Familiarity with a test can enhance performance because “desired” answers can be learned.
o Effects of testing can be an issue in studies in which a large battery of questionnaires is administered
to patients, where patient fatigue can affect responses.
o Triangulation of results from several instruments and using alternative forms of a test can address this
threat.
o A mixed methods design can also be used to confirm quantitative results with qualitative findings.
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 THREATS TO INTERNAL AND EXTERNAL VALIDITY (CONT’D)

Internal Threats to Validity (cont’d)

• Instrumentation is a threat when there is a change in the measurement instrument or scoring
between pre- and post-intervention points.
o With biomedical and technical instrumentation, calibration and instrument reliability should be
confirmed.
o Instrumentation is an issue with measurement tools that perform differently at the ends of a scale
than they do at the midpoint.
 This situation results in what are termed “floor” or “ceiling” effects in measurement.
 With ceiling or floor effects, changes in the variable being measured may not be observable if
the value is already at the high or the low end of the possible scale.
o This type of threat is of concern when measurement is done by a single observer, when data are
collected in person, and in studies in which pretest values are already at extreme high or low
values.

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 THREATS TO INTERNAL AND EXTERNAL VALIDITY (CONT’D)

Internal Threats to Validity (cont’d)

• Statistical regression is a natural statistical phenomenon in which individuals who have extreme
results (either high or low) will have scores that move toward the mean on a repeated test, and the
resulting group mean will change.
• Attrition is a threat when individuals who drop out of a study or are lost to follow-up are different
from those who remained in the study in ways that influence results.
• Contamination occurs if treatment is diffused to subjects in different study groups because
participants interact with and learn from each other.
• Compensatory equalization of treatments can occur when staff or administrators feel that persons
who do not receive the intervention are lacking a benefit and compensate for this perceived lack.
o This threat is most likely in studies in which group assignment is known to others and no
placebo, active, or attentional controls are used.

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 THREATS TO INTERNAL AND EXTERNAL VALIDITY (CONT’D)

Internal Threats to Validity (cont’d)

• Compensatory rivalry for participants with the less desirable treatment is a situation in which
subjects in the control group feel neglected or see themselves as underdogs, and they are motivated
to compete or perform in an attempt to reverse expected effects of an intervention.
o This is most problematic with study designs in which subjects know they are in the control group
and where intact units of staff are assigned to interventions.
o Blinding study subjects to group assignment and provision of placebo, active, or attentional control
conditions can reduce this type of threat.
• Resentful demoralization of no-treatment groups can be an issue if individuals who are not
receiving what is seen as a more desirable treatment become discouraged and perform at a lower
level in retaliation or because they feel dejected.

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 THREATS TO INTERNAL AND EXTERNAL VALIDITY (CONT’D)

Internal Threats to Validity (cont’d)

• Selection can be a threat when there is a difference between participants in the study groups.
• Can occur because subjects choose to be in a certain group, or they are chosen for a certain
group.
• May occur when there is a lack of random assignment (e.g., in a quasi-experimental two-group
study), where there is a lack of equal probability for being chosen for the different study groups.
• Lack of treatment fidelity occurs when the intervention is not provided consistently to all study
subjects.
o Provider training, provision of clear guidelines, references, and treatment algorithms can enhance
performance of the intervention consistently.
o When the intervention is dependent on patient use, patient reminders and patient diaries or
posttest interviews can be used to assess patients’ adherence to interventions.

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 THREATS TO INTERNAL AND EXTERNAL VALIDITY (CONT’D)

External Threats to Validity

• External threats to validity refer to the extent to which findings can be generalized to and across
different people, time, settings, and conditions.
• Interaction of selection and treatment occurs when the researcher is recruiting participants for the
study.
o It may be challenging for the researcher to get a representative sample dependent on the nature of
the study and the mode of recruitment.
o One method of handling this threat is to ensure that taking part in the study is as convenient as
possible to be more inclusive of participants (e.g., those with limited time to participate in a study).
• Interaction of setting and treatment can be a threat to external validity if a limited number of settings
are used that limit generalizability to other settings.
• Interaction of history and treatment can be a threat when events that took place prior to and during
an intervention have an effect on study outcomes in an untended direction, with the intervention itself
not fully contributing to the results.
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 IMPLEMENTING RESEARCH IN THE CLINICAL SETTING

• Operationalizing a study in a clinical setting requires a design that is practical and well-constructed to
minimize threats to validity.
• Before conducting a large clinical trial in the clinical setting, it is valuable to
o obtain expert opinion
o perform a feasibility study to test the study plan, methods, and acceptability to patients
o consider patients, family members, healthcare providers, other hospital employees, environmental
resources, and how and when care delivery occurs when designing an intervention
• Clinical settings maintain computerized data sets for electronic health records, results reporting,
quality reporting, and billing.
o Many quality measures have been converted to e-measures, which can be collected as part of the
electronic health record.
o These data can be used for descriptive analysis and measurement of outcomes.
o Data can be incorporated into interventional studies to provide information about the characteristics
of the subjects. 32

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 DATA ANALYSIS

Descriptive Statistics
• Descriptive statistics are used whenever the researcher wants to describe the findings within a
sample of observations.
• The first step in organizing data is a frequency distribution, which provides a method to arrange
observed values from lowest to highest and note how often each value was counted.
• There are three important characteristics of frequency distributions:
o The shape of the distribution of values can occur in different configurations.
 If a distribution is symmetric, then the two halves are equal to each other.
 If a distribution is asymmetric, then the two halves are not equal to each other, and the data
are skewed, resulting in a longer tail on the right or the left of a pictorial representation of the
data.
 If a distribution has more than one peak, then it has a multimodal distribution.

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 DATA ANALYSIS (CONT’D)

Descriptive Statistics: Characteristics of Frequency Distribution (cont’d)

o Central tendency of the sample in a given attribute is one way to demonstrate what is common in
a set of scores—how things look on average.
 The mean is the sum of scores divided by the number of scores.
 The median is the 50% percentile of distribution—the point at which one half of the scores are
lower, and one half of the scores are higher.
 The mode is the score that occurs most frequently.

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 DATA ANALYSIS (CONT’D)

Descriptive Statistics: Characteristics of Frequency Distribution (cont’d)

o Variability in a set of scores includes the range, standard deviation, and variance.
 The range is the difference between the lowest and highest scores.
 The standard deviation and variance are calculated from the deviation (distance) of all
scores from the group mean. These provide a view of the overall dispersion of results.
 The standard deviation is a linear measure.
 The variance is calculated as the standard deviation squared, providing a more three-
dimensional picture of the overall difference in the variable being represented by the data.
 The standard deviation and variance can be compared between groups to evaluate the
magnitude of differences.
Inferential Statistics
• Inferential statistics are used to extrapolate findings beyond a single data set to determine the
probability that results are applicable beyond the individual sample.
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 HYPOTHESIS TESTING AND ERROR

• Inferential statistics use the scientific method, posing a hypothesis that is then tested using probability
theory.
o By convention, a researcher proposes a null hypothesis and then calculates a probability of error in
concluding that the null hypothesis is false.
o To support the researcher’s theory that there is some relationship between variables, the
researcher has to show that the opposite conclusion, the null hypothesis, is not true.
• In probability theory, there are two types of errors in hypothesis testing that can occur:
o A type I error occurs if one concludes that the null hypothesis is false when it is actually true.
o A type II error occurs if one concludes that the null hypothesis is true when it is actually false.
• The probability of a type I error is termed alpha (α), and the probability of a type II error is beta (β).
• Another approach for hypothesis testing is the use of a confidence interval (CI) rather than calculating
an actual p-value.
• To minimize the risk of a type II error, the researcher needs to choose the largest sample size
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 POWER

• Statistical power findings give further information about the reliability of conclusions.
o Power analysis is generally used to determine the sample size that is needed, at a specified level
of alpha, to have confidence in the findings.
o Power analysis can also be used in adaptive study design to make changes in sample size.
• Usually, researchers calculate sample sizes needed to achieve results at least at 80% power.
• Power at the level of 0.8 indicates that the researcher can expect that 80% of the time, the study
would yield the correct conclusion in terms of rejecting the null hypothesis.

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 EFFECT SIZE

• Effect size is a concept that indicates the magnitude of the relationship observed between variables.
• Strength of effect can be evaluated in research results from statistics such as the following:
o Pearson product–moment and other correlation coefficients: the Pearson product-moment
correlation, designated by r, has a possible effect size between +1 and ‒1.
 The correlation coefficient squared (r2) shows the proportion of the total variance in the
dependent variable that is explained by the independent variable.
o Standard mean difference (SMD): calculated as the difference between population means divided
by the variance.
o Odds ratio (OR): used when one of two possible outcomes is evaluated in response to an
intervention or exposure to some event. OR is a practical measure that can be calculated in a
clinical setting to determine the odds of a particular event or response for a patient or groups of
patients.
o Relative risk (RR) ratio: calculated as the incidence of an outcome in one group divided by the
incidence of that outcome in another group
o Statistics such as Cohen’s d and Hedges’ g 38

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 DATA MANAGEMENT AND USING CLINICAL RESEARCH

• Once research data are collected, they need to be stored and prepared for analysis. These processes
are generally referred to as data management.
• Data management needs to address the following:
o How and where raw data will be stored or accessed in study implementation and analysis to protect
subject confidentiality
o How data will be coded and computerized
o The software that will be used for analysis
• A research planning checklist can be used to both plan research and evaluate some aspects of
published research for clinical application.
• Considerations for the use of research in clinical practice include the following:
o Study design and implementation
o Appropriate variables
o Measurement
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o Sources of bias and validity threats
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