Title abc123 version x1week 5 programmatic assessment

Title
ABC/123 Version X
1
Week 5 Programmatic Assessment
PSY/410 Version 6
University of Phoenix Material
Week Five Programmatic Assessment
Scenario
Abby is a 20-year-old female college student. For at least the
last 3 months, Abby has experienced ongoing anxiety and worry
without a specific cause for these feelings. She has been restless
and has noticed that her muscles feel tense and that these
symptoms are beginning to affect her behavior in a way that is
causing her to become distressed and that is preventing her from
being able to complete her normal tasks. Abby correctly
believed that it was normal to feel a little anxious sometimes;
however, as the semester has progressed, she has not begun to
feel significantly more comfortable.
On the recommendation of a friend, Abby visited the
university’s counseling center and talked to Dr. Smith. Dr.
Smith was warm and welcoming and, after discussing the limits
of confidentiality with Abby and obtaining informed consent,
encouraged Abby to describe her concerns. Dr. Smith listened
attentively and asked Abby a few questions. They both agreed
on an appointment date and time for the next week. Dr. Smith
gave Abby a homework assignment to keep a written log of the
negative thoughts or assumptions she has during the week and
the circumstances under which those thoughts occurred. Abby

was asked to bring the log with her to her next
appointment.Short-Answer Questions
Answer the following questions based on the scenario above.
Answers should be short and concise.
1. Which DSM-5 disorder matches the symptoms Abby is
reporting?
2. Which theoretical model does the homework assigned by Dr.
Smith match?
3. If Dr. Smith recommended medications only, which
theoretical model would this match?
4. If Dr. Smith recommended medications in addition to
therapy, which theoretical model would this match?
5. If Dr. Smith completed a free association exercise with Abby,
which theoretical model would this match?
6. If Dr. Smith used unconditional positive regard in the
treatment, which theoretical model would this match?
7. If instead of the symptoms listed in the scenario, Abby
reported the following:
She had been in a car accident where she feared for her life. She
had sleep disturbances including nightmares and became
uncomfortable at the thought of driving, to the point that she
avoided driving. She now believes she is a horrible driver,
although her friends assure her this is not true. If these
symptoms have lasted for longer than a month, which DSM-5
disorder label might match her symptoms?

Every day for the past 2 weeks she felt down or sad for most of
the day, had noticed an increase in her appetite, had been unable
to sleep or concentrate, and felt tired. Additionally, this was
interfering with her goals and tasks, and she reported that she
had never felt manic or hypomanic. Which DSM-5 disorder
label might match her symptoms?
Every day for at least the past week she felt irritable with
persistently increased energy and talkativeness, was easily
distracted, did not seem to need sleep, and noticed that this
behavior was interfering with her job. She reported that she has
felt these symptoms before in her past and that she has also felt
depressed sometimes. Which DSM-5 disorder label might match
her symptoms?
Throughout her life, she has always been suspicious of others.
She reports that she really would like to have good
relationships, but even as a child she knew that others,
including family members, could not be trusted. She feels that
she needs to stay on guard to protect herself. Which DSM-5
disorder label might match her symptoms?
She began drinking when she was 18 and now needs to drink
more or higher concentrations of alcohol to continue to
function. She reports that she has lost her part-time job because

of her drinking and is in danger of failing out of college. She
was hospitalized last weekend due to experiencing delirium
tremens during withdrawal, and the doctor explained to her that
she could die from this disorder. Abby recognized that her
drinking was interfering with her life, and she knew that she did
not want to die. Which DSM-5 disorder label might match her
symptoms?
12. If instead of the symptoms listed in the scenario, Abby’s
former roommate reported the following:
During a significant portion of the past month, Abby had talked
to herself out loud and told her roommate that she had heard
voices telling her to harm herself. Her roommate reported that
Abby had told her that she occasionally stated that she was Joan
of Arc and that the school mascot was stalking her. Her
roommate asked to change rooms, and now that Abby was living
alone, she did not appear to have bathed in more than a week.
This was not typical behavior for Abby, as she had been known
to be meticulous with her appearance and hygiene. The
roommate expressed her concern for Abby and stated that
although she had noticed some of these behaviors since she first
met Abby more than 6 months ago, the behaviors seem to have
increased over the past month. Which DSM-5 disorder label
might match her symptoms?
13. If Abby were 5 years old and, instead of the symptoms
listed in the scenario, her symptoms included nightmares,
physical complaints, recurrent separation-related fear, and a
refusal to leave home, what DSM-5 disorder label might match
her symptoms?
14. If Abby were 67 years old, and instead of the sympto ms
listed in the scenario, had no major medical issues, had never
been diagnosed with a neurocognitive disorder, and her
symptoms included a substantial decline in the cognitive

functioning areas of memory and attention that interfere with
her independence, what DSM-5 disorder label might match her
symptoms?
15. Dr. Smith discussed the limits of confidentiality and
required Abby to sign an informed consent form before
treatment. These are examples of items used to protect the
patient’s ______________.
Copyright © XXXX by University of Phoenix. All rights
reserved.
Copyright © 2018 by University of Phoenix. All rights reserved.
NEPHROLOGY NURSING JOURNAL ■ November-December
2007 ■ Vol. 34, No. 6 635
edge that is said to be universal.
Counter this with an evaluation of
how a program worked within your
institution; for instance, your unit
wants to assess whether instituting a
self-medication program is effective
on your renal floor. You found that
the program or part of the program
worked and now you want to write it
up as research. Before the project can
be categorized as research, several
questions need to be answered. For
example, has the project undergone
the scrutiny of controlling the vari-
ables that may influence the out-
come? Has the project followed the
research process? Were the subjects

aware that data was being collected
on them? A key question to ask: was
the data collected in a systematic
manner? Did you get good outcomes
because the sample only included
those who successfully completed
your program (thus introducing bias
into the outcomes by the way that you
chose your subjects)? Once these
questions have undergone this type of
scrutiny, can you then say that the
outcomes were based on the interven-
tion (self-medication)? These ques-
tions can then determine if your out-
comes can be applied outside your
individual organization and be a part
of the body of universal knowledge. If
so, then the project can be called a
research study.
Research studies are not usually
determined after the data is collected;
however retrospective reviews of
process. Don’t let it be daunting, as
there are nurses out there who are
professional researchers. Just like we
go to medical experts when we have
a medical concern, we can turn to our
nurse research experts when we have
a research concern.
The first concept that we need to
clarify is ‘systematic.’ Our approach
to data collection is methodical and
organized in such a way as to answer

the clinical question posed. There are
sections in nursing research textbooks
devoted to principles of systematic
data collection and sampling strate-
gies; key components of a research
study. It is advisable for any nurse
researcher (the authors included) to
have on hand a general research text-
book (LoBiondo-Wood & Haber,
2002; Polit & Beck, 2004). Referring
to a textbook often helps clarify
threats to your systematic collection
of information. All researchers, clini-
cal or basic, must determine the best
way to collect study data so that the
outcomes can be generalizable. If
there is not enough attention paid to
how the data is collected, the out-
come is not reliable and thus not
applicable to a larger population.
The second concept to clarify is
‘universal knowledge.’ What is uni-
versal knowledge? You can say that if
your research adds new understand-
ing for a given problem that helps
broaden what we know for a popula-
tion at large, then the new idea
becomes part of the body of knowl-
The Nursing Research Process
Rebecca P. Winsett
Ann K. Cashion
Rebecca P. Winsett, PhD, is Associate Professor,

College of Nursing, University of Tennessee Health
Science Center, Memphis, TN.
Ann K. Cashion, PhD, RN, FAAN, is Associate
Professor and Chair, Department of Acute and
Chronic Nursing, College of Nursing, University of
Tennessee Health Science Center, Memphis, TN.
She is a member of ANNA’s Memphis Blues
Chapter.
The federal government definesresearch as the systematic col -
lection of information in orderto increase universal knowl -
edge (Department of Health &
Human Services, 1991). There are
several complex concepts imbedded
into that definition, but before we dis-
cuss the concepts we need to clarify
the word ‘research.’ The use of the
noun ‘research’ implies a systematic
investigation to increase universal
knowledge; one that is thoughtfully
planned and executed. The noun
‘research’ is not to be confused with
the verb ‘research,’ where one might
state, “I researched this and found….”
Our day is full of researching infor-
mation and using that information to
assist us in our work. But for the pur-
poses of this chapter, we speak only to
the noun ‘research’ and the system of
inquiry that surrounds our investiga-
tions to answer clinical questions. It is
the noun ‘research’ that often intimi-
dates the clinical nurse. We hope to
dispel some of the intimidating factors
and light the flame of inquiry. To help us

understand research, let’s explore the
This chapter on research in nursing was included in ANNA’s
Career Fulfillment in Nephrology Nursing: Your Guide to
Professional Development (2nd edition), which was published in
September 2007. This chapter encourages nurses to participate
in
the research process by providing an overview of the nursing
research process, including the steps to designing a research
project,
and answers to frequently asked questions. The objectives of the
chapter are to: (a) define the nursing research process, including
the systematic and universal knowledge concepts along with
overviews of process improvement and evidence-based practice;
(b)
identify the steps to designing a research project, including
identifying a clinical problem and formulating a research
questions,
conducting a review of the literature, and providing an overview
of the research design; (c) provide an overview of the study
methodology, including data analysis and protecting human
subjects; (d) discuss available funding opportunities and the
profes-
sional obligations that go with these opportunities; and (e)
provide answers to frequently asked questions regarding nursing
research to help demystify the process.
To order your
copy, visit the
ANNA Web site at
www.annanurse.org
2007 ■ Vol. 34, No. 6636

large databases have been done and
do have scientific merit. It goes back
to the importance of the research
question. Some questions are ade-
quately answered by a “look back” at
data, but most will require a prospec-
tive inquiry. The research question
and number or amount of data need-
ed to answer the question will dictate
the design. Research is a process in
which the investigator actively deter-
mines the question to answer, creates
a data collection and analysis plan as
well as a plan to control for events
(known as threats) that would influ-
ence the outcome (Burns & Grove,
2005). Evaluating a system or a pro-
gram on the unit is still an excellent
way to focus on clinical outcomes.
Here you have to distinguish process
improvement from research. To a
novice this may be difficult because
these two methodologies overlap in
some ways, but by and large, process
improvement serves the institution
and is not considered to increase gen-
eralizable knowledge. The informa-
tion gleaned from evaluating your
practice is no less important; however
the label of research sets the standards
for a different guiding body. Once we
move into the realm of research,
oversight by an institutional review
board and human subject protection
are required.

Research questions and the study
methodology do not have to be
grand; we just stretch what we know
so that it is available to others “to
know.” Once we clarify the defini-
tions of process improvement and
then evidence-based practice
methodologies, understanding the
research process will be much clearer.
Process Improvement
Process improvement is a method
to recognize and prioritize problems
on your clinical unit or within the
institution (Davidoff & Batalden,
2005). The goal of process improve-
ment is to fix problems that can
improve patient service or outcomes.
There are methodologies developed
just for process improvement and you
may be familiar with a few of these;
for example: FOCUS PDCA, rapid
cycle PDCA, Six Sigma, or Lean
(Medical Risk Management Asso-
ciates, 2006; Pyzdek, 2003; Zidel,
2006). These methodologies provide
guidelines to help improve the sys-
tematic collection of data for process
improvement projects, and can, in
some instances, be considered
research, but by-in-large, do not meet
the scrutiny to be considered
research. Process improvement is

very important and is not to be con-
sidered less valuable than nursing
research. Even though the processes
are similar, it is important to remem-
ber that some questions need a
process improvement methodology
and other questions require a nursing
research methodology. Successful
process improvement strategies may
warrant publication, but these are not
generally publishable in nursing
research journals.
Evidence-Based Practice
In nursing, we also search for best
practices by using evidence to guide
our clinical practices. Evidence-based
practice differs from research in that
we are examining the published liter-
ature about a given topic in order to
help make decisions about patient
care (Sackett, Rosenberg, Gray,
Haynes, & Richardson, 1996). The
methodology of determining and
evaluating the evidence starts with a
question and proceeds to a thorough
search of the published literature. The
literature or evidence is ranked and
critiqued, and determinations of
whether practice changes are needed
are based on the conclusions of the
evidence reviewed. Using evidenced-
based practice is a sophisticated use of
the published research. Having a
solid evidence-based practice text-

book helps to clarify the processes
that are needed to acquire and cri-
tique the evidence (Malloch & Porter-
O’Grady, 2006; Melnyk & Fineout-
Overholt, 2005).
Both process improvement and
critiquing evidence to modify practice
are important for nurses, and each has
some overlap with the nursing
research process. One is not more
important than the other – whatever
question that you ask requires that
you use the methodology that best
answers the question. This chapter
focuses on the nursing research
process, and if you are a skilled user
of process improvement or evidence-
based practice, you will recognize
many of the steps of the nursing
research process. Understanding the
research process may help you to
identify and clarify a researchable
question and provide the guidelines
for you to institute a research study in
your unit. Not all nurses are required
to conduct nursing research, but part
of our professional obligation is to
understand and critique the research
published in our field and participate
in determining if findings are applica-
ble to our settings. The American
Nurses Association (ANA) asserts that
participating in research is critical to
provide the knowledge needed for

practice, and that the educational
level of the practicing nurse deter-
mines how the nurse can best con-
tribute to nursing research (Council of
Nurse Researchers & Council of
Nursing Practice, 1993). The research
educational standards differ for each
nursing degree level. For example,
the associate degree nurse may not
have a formal research course but is
taught the importance of constructing
and following policy and procedures
within each setting. The baccalaure-
ate nurse has preparation to read and
critique the published literature to
develop the culture of inquiry. The
educational standards for the master’s
level nurse has changed from design-
ing and implementing a small
research project to developing a
sophisticated approach to synthesiz-
ing the research literature to modify
nursing practice. No matter the level
of education, your role in following
the protocols of a nursing research
project being done on your unit is just
as important as those who participat-
ed in the design of the study. Not
every nurse needs to lead a research
team; however, if the desire is there,
use your resources around you to
help you be successful.

2007 ■ Vol. 34, No. 6 637
Novice researchers may gain
expertise by participating as study
coordinators or research assistants.
Teaming up with a well-seasoned
nurse investigator is another way of
gaining experience. Most principal
investigators wet their research
appetites as study team members
prior to taking the lead position.
Research Process - The Steps to
Design a Research Project
Identifying a Clinical Problem
and Formulating a Research
Question
Identifying the practice problem
and crafting the research questions
are the most important steps of the
research process. The steps we discuss
are listed in Table 1. No one is better
at identifying a practice problem than
a practicing nurse (Council of Nurse
Researchers & Council of Nursing
Practice, 1993). This process begins
with the nurse asking the question
“what would happen if…?” or “does
this always happen when…?” One of
the best ways to identify a problem of
interest is to think about what bothers
you at work; oftentimes, this creates

passion for investigation. Realize that
as a novice investigator, it will take
perseverance and attention to detail
to complete the research process.
Narrow your focus; there is no better
advice to give to a novice researcher
than those 3 words. Once you identi-
fy a problem area, write down sever-
al questions of interest and seek
advice on what is feasible to pursue.
As we discussed earlier, relying on
research experts to help guide you
through the research process is sug-
gested. Discussing the importance of
your question helps identify the sig-
nificance of the problem and purpose
of your study. The results of the study
need to have the potential to con-
tribute to a larger body of knowledge
and specifically to patient care.
One significant roadblock for
novice researchers is identifying a
problem that is too large and too
unfocused. For example, a large
problem would be “Determine why
hemodialysis patients become septic.”
Renal nurses can think of lots of rea-
sons why patients become septic and
want to explore each and every one
of them – and then see that the ques-
tion is far beyond their ability to
answer. This global problem appears
monumental so that it is easy to con-
sider dropping the investigation all

together. If you take a more narrow
approach and state the problem as
“identifying the clinical characteristics
associated with septicemia in
hemodialysis patients,” this question
seems feasible. The authors highly
recommend that the problem and
research questions err on the side of a
narrow focus of interest. One does not
have to cure world hunger to add to uni-
versal knowledge.
Formulating the research question
that is narrow in scope, with clearly
identified variables to study creates
the guide for the rest of the process.
Spend your energy in creating a
researchable question. The attention
that you pay to the research question
will set in motion how you will
accomplish the research project. The
question drives the ‘so what’ and thus
your review of the literature. The
research question drives the study
design, thus determining the choice of
your methodology and data collec-
tion. If your research question is
unclear, then you will feel lost in the
rest of the process.
You will also need to focus on the
practical issues related to resources
needed to accomplish your project.
Resources such as money, time, abili-
ty to collect data, and statistical sup-

port will need to be explored with
your administrators as well as your
medical, nursing and other colleagues
who may be asked to help recruit
patients or administer the interven-
tions. There may be other issues that
you will have to address as you move
further in the planning stages, but
most feasibility issues can be over-
come if identified and addressed prior
to starting the study.
Review of the Literature
You may have started with reading
the scientific literature that led to your
clinical question or you may have
asked the clinical question and then
went to the literature to see what has
already been published on your topic.
Either way, using published research
can help you as you finalize your
research question. You can focus on
particular topics once you have:
• obtained a clearer picture of what
you would like to study,
• evaluated the literature to substan-
tiate that the study needs to be
done,
• identified a unifying conceptual
framework, and
• gathered ideas for study design.

Replicating a study that has
already been published can be a good
way to determine if findings are appli-
cable in a different setting or with a
different population, fostering valida-
Table 1
The Steps in the Research Process
Problem formulation-research question
Review of the Literature
Methodology
Choose the appropriate design
Prepare the procedural steps
Assess validity threats
Data collection and data processing
Data analysis
Interpreting the data
Writing the results
2007 ■ Vol. 34, No. 6638
tion and strengthening the overall

body of evidence.
There are several methods that can
be used to find published articles.
Commonly, researchers conduct an
internet search using online access to
medical databases such as MEDLINE
or the Cumulative Index to Nursing
and Allied Health Literature
(CINAHL). Search engines like Pub-
MED or OVID are user-friendly and
nurses can easily obtain printed
abstracts and publications on any
medical topic of interest. Other
sources for information include web-
sites that collect, analyze, or distribute
information about diseases such as the
United States Renal Data System
(USRDS) and United Network for
Organ Sharing (UNOS). For exam-
ple, if you are interested in the rate of
end stage renal disease by age in your
region, this information may be found
on the USRDS website (http://
www.usrds.org).
While we often are more con-
cerned with published research stud-
ies, other sources for relevant informa-
tion include integrated reviews or clin-
ical expert opinions. These types of
articles often can help refine the signif-
icance and the feasibility of a research
problem and questions. Do not hesi-
tate to include a medical librarian in
your search for relevant literature.

Experienced librarians not only have
access to numerous search engines,
but librarians in academic centers usu-
ally are very good at phrasing search
words and topics in order to obtain
the best possible results.
The Research Design
Experimental vs. Quasi-experi-
mental. There are many types of
research designs, but all have the
same purpose…to provide a frame-
work and plan for answering the
research question (LoBiondo-Wood &
Haber, 2002). Most of us are familiar
with the classic double blinded, ran-
domized controlled experimental
design frequently used in clinical drug
trials. Experimental designs have
three characteristics:
• Randomization. Subjects are dis-
tributed to either the experimental
or the control group by a system
that gives each subject an equal
chance of landing in one group or
the other.
• Control. A control group is formed
where no intervention is conduct-
ed.
• Manipulation. An intervention is
given to only some of the subjects.

Most nursing studies are not true
experimental studies because of the
nature of the clinical questions and
the inability of having a true con-
trolled environment. Frequently nurs-
es employ quasi-experimental
designs. Quasi-experimental designs
can be similar to experimental
designs, however, not all three char-
acteristics are present. For instance,
there may be no control group or the
subjects are not randomized to study
groups. Limitations of experimental
designs are that they may be expen-
sive to carry out and can involve
many months of follow-up (Hulley et
al., 2001). However, sampling tech-
niques are important even in quasi-
experimental studies. Outcomes are
strengthened by the sampling strategy
(Winsett et al., 2007).
Non-experimental designs. Non-
experimental research designs are fre-
quently used by practicing nurses
when they need to document that a
problem exists. Types of non-experi-
mental designs include descriptive,
comparative, or correlational designs.
For example, many of us have read
descriptive or exploratory studies
where the purpose was to describe a
phenomenon such as the depression
level of a patient group. We may also
be exploring the association between

two clinical outcomes, such as the
relationship between blood pressure
and depression in hemodialysis
patients. Usually, once the phenome-
non is described and there is an
agreement that a problem exists, an
intervention study can be conducted
to examine ways to alleviate the prob-
lem and provide better health care. In
this case, the research question is
often best served by a quasi-experi-
mental study design.
Non-experimental designs can be
prospective (following subjects for-
ward) or retrospective (reviewing his-
torical records). Using retrospective
data can be effective and less threat-
ening to a novice investigator.
Descriptive or correlational designs
using retrospective methodology
would use information already col-
lected in a database (or patient med-
ical record) and characterize a prob-
lem or determine if a relationship
exists. A significant limitation of retro-
spective research studies is that the
researcher is restricted to the data that
was collected at that time. For exam-
ple, if weight or blood pressure was
not entered into the record or a crea-
tinine level was not drawn and you
needed that data, the nurse researcher
cannot go back and recreate those
data points.

What Design Should You Use?
While this chapter is not consid-
ered to be an exhaustive discussion of
research design, the most important
determinant of your research design
is your research question. The ques-
tion itself drives the design. Let’s take
the example of our hemodialysis
depression/blood pressure phenome-
non. Suppose you ask the question:
What is the blood pressure of
hemodialysis patients who are being
treated for depression? What type of
study design would be used? This
could be a retrospective non-experi-
mental design where you review
medical records and explore the phe-
nomenon of blood pressure in
patients who are or are not on antide-
pressants.
Suppose you ask the question:
What is the relationship between
depression treatment and blood pres-
sure during dialysis for patients who
are treated with anti-depressants?
This study could be prospective non-
experimental where you assess blood
pressure during dialysis (at points you
determine are important) and com-
pare the blood pressures between
those treated with anti-depressants
with a group that is not on anti-
depressants.

Let’s take that question one step
further. You know that there is a dif-
ference in blood pressure for those on
2007 ■ Vol. 34, No. 6 639
anti-depressants and now you want to
know if you can impact the blood
pressure. So you ask the question,
“What is the impact of cognitive ther-
apy on blood pressure during
hemodialysis in patients who are
treated for depression with anti-
depressants?” This study could be
quasi-experimental where you ran-
domize those under treatment for
depression into control and experi-
mental groups. The control group
receives standard care and the exper-
imental group receives cognitive ther-
apy at some point during (or before)
hemodialysis. As you can see, the
question itself defines what type of
design that is used.
Internal and External Validity
Two important concepts when dis-
cussing research design are internal
and external validity. Internal validi-

ty is the extent to which study results
are truly the results of the study and
not a product of influences outside
the study. External validity is the
extent to which study findings can be
generalized to other groups of
patients (Burns & Grove, 2005). Of
course, the researcher would want
few, if any, external influences on the
study; and the more the study results
can be generalized to other patient
groups the more relevant and impor-
tant the study. Tables 2 and 3 provide
a list of common threats to internal
and external validity.
Study Methodology
Once the problem has been identi-
fied and described, the research ques-
tions conceived and the design cho-
sen, it is time to outline your method-
ology. The study design is the map of
how the study will be conducted,
while the study methodology is the spe-
cific instructions on how you will go
about completing your specific study.
The study methodology has a some-
what standard format that includes
sections describing the study design,
methods for selecting subjects, proce-
dures to the study, instruments to be
used, and the analysis plan. The study
methodology is often referred to as

the study protocol.
You should initially focus on the
procedures, including all of those lit-
tle steps that the investigator and the
subject will do in order to collect the
data. This is an important step in
study validity, so it is critical to be
very detailed in identifying each step
of the procedures. It is beneficial to
break down the recruitment of sub-
jects into multiple steps, such as iden-
tifying potential subjects from chart
review, approaching potential sub-
jects prior to initiating dialysis (for
example), and following-up with two
phone calls during the evening hours
made by their assigned nurse, etc. As
you create a list of all the tasks to be
completed in the study protocol,
Note: Used with permission from Progress in Transplantation
(Winsett et al., 2007).
Table 2
Threats to Internal Validity
Internal Validity - The extent that the effects of the study are
related to the study and not extraneous events
Historical events Events or interactions with life outside of the
study environment that may influence
subjects responses
Maturation Effects of learning during the course of the study
Does history or events impact one group over another?

Testing effects Subjects altering responses based on previous
testing or providing socially acceptable
responses
Instrumentation Are the instruments or questionnaires used in a
study reliable and valid for the popula-
tion? Is data collected the same across the entire study period?
Statistical regression Did the treatment effect the change (Type
1 error)? Was there sufficient variability in the
data and adequate sample size to detect a change if present
(Type 2 error)?
Selection bias Did the sampling plan assure equal opportunity to
participate in the study? If nonproba-
bility sample was used, are there safeguards in place to
generalize from the sample?
Mortality The effect of drop out in the study (by any means)
and how does the investigator
address study mortality?
Diffusion of treatment The controls over the intervention group
and how the investigator assures that the con-
trol group and the intervention group are not contaminated
Compensatory equalization/rivalry Acts from others or from
subjects that alter the participation in the assigned group.
Resentful demoralization Subjects perceived that they are
receiving less than desirable treatment and opt to
withdraw from the study.

2007 ■ Vol. 34, No. 6640
threats to study validity are often
identified.
Planned sample size and subject
inclusion and exclusion criteria are
described in the methodology. Deter-
mining appropriate sample size is an
important part of the study. A proce-
dure known as power analysis is con-
ducted in order to determine sample
size. A power analysis tells the inves-
tigator how many subjects are needed
in order to detect if a significant rela-
tionship exists between the study vari-
ables. A biostatistician may be need-
ed to determine a power analysis.
We are often reminded as we begin
to develop our inclusion criteria that
there is a phenomenon known as the
“disappearing subject.” This means
that we created the perfect subject
inclusion criteria so that we can mini-
mize threats to study validity, but find
once the study is started, all of a sud-
den there are no subjects that meet the
inclusion criteria. So, our advice is to
be as broad as possible when develop-
ing inclusion criteria. It may be possi-
ble that the threats you had identified
earlier can be controlled in other ways.
Other important items to be

addressed in the methodology
include identifying and describing
proposed instruments such as sur-
veys, questionnaires (i.e., depression
or quality of life) and clinical tools
(i.e., thermometers, blood pressure
cuffs). Using previously validated
tools can save a tremendous amount
of time and also gives your study
credibility. Once you have the proce-
dure clearly outlined, take the time to
map out a timeline for completion.
Planning for each part of your study
can help you set realistic goals. Your
study methodology will also describe
your intended data analysis plan,
including the variables to be collected
and how you will protect the data.
Data analysis. The type of design
chosen for the study will determine
the statistical analyses conducted. For
example, a study characterizing
depression levels may use descriptive
statistics to answer the research ques-
tion, while a study with a quasi-exper-
imental design may use inferential
statistics to examine associations and
identify predictors of risk among the
variables. Deciding the data analysis
plan is important before you begin to
collect data. If you do not have access
to a biostatistician, at least discuss this
very important issue with a veteran
nurse researcher. Your quality depart-

ment in your hospital may have
someone experienced in data analy-
sis. While they may …

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