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please see annotated paper and make corrections please. Please revise the paper as needed and keep it the 10 page limit (except appendicies and references) (sample is included) I think the title on all should be my picot question. Please see rubric attached, please add 2 background question to the introduction (section 1) and make sure to answer those background questions in the literature review section.Please modify poster as appropriate (attached)
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1
The Impact of Oral Contraceptives and IUDs as Contraceptive Methods for Obese Women
Ages 25-40
AN ASSIGNMENT
SUBMITTED IN PARTIAL FULFILLMENT OF THE REQUIREMENTS FOR THE
DEGREE OF MASTER OF SCIENCE IN NURSING
IN THE GRADUATE SCHOOL OF THE
TEXAS WOMAN’S UNIVERSITY
COLLEGE OF NURSING
BY
DANIELLE MITCHELL
NURS 5695: PRECEPTORSHIP II
DR. JANET WHEAT
OCTOBER 1, 2023
2
The Impact of Oral Contraceptives and IUDs as Contraceptive Methods for Obese
Women Ages 25-40
Although women using contraceptive methods have relatively successful rates, many
develop complications in their adult lives. The debate on the impact of obesity on women using
contraception continues to invoke various options across the board. Understanding the extent to
which hormonal and non-hormonal contraceptive devices contribute to complications in obese
women is integral to developing measures that act as interventions for the most adverse methods.
This paper aims to critically compare the impact of oral contraceptives and IUDs as
contraceptive methods for obese women ages 25-40, assessing which of the two groups is at
higher risk of developing blood clots.
Significance
Researchers widely acknowledge the association between obesity and the excess estrogen
in hormonal contraceptive methods to pose cardiovascular risks. While even moderately healthy
women suffer the risk of being affected by cardiovascular complications, obese women often
have underlying issues that enhance the probability of the risks manifesting much earlier in their
lives (Manrique-Acevedo et al., 2020). This research is necessary to establish the connection
between the oral contraceptive pill and blood clot formation in obese women.
Background
While exploring the connection between contraceptives, obesity, and chronic blood clots,
it is important to understand whether oral contraceptive pills and IUDs are responsible for the
same results. In this case, the major issues are the relationship between contraception in obesity
and the formation of blood clots. In addition, obese women can prevent the cardiovascular risks
associated with contraceptive methods if there is clear evidence of these risks. The purpose of the
Commented [LN1]: This needs to be re-centered
3
study is to establish the etiology of blood clots in obese women who are under specific
contraceptive treatments.
PICOT Question
Are obese women ages 25 to 40 (P) who take oral contraceptives at greater risk (I) for
developing blood clots (O) compared with obese women ages 25 to 40 (P) who use IUDs for
contraception (C) over a 5-year time frame (T)?
ACE Theoretical Model
The ACE theoretical model allows researchers to perform research in five critical stages:
discovery, evidence summary, translation, integration, and evaluation. The evidence-based
project (EBP) would require a qualitative approach to determine whether obese women under
various contraception methods are at risk of having blood clots. In this case, using unstructured
interviews as a qualitative research methodology, women would be assessed to determine the
truth in this hypothesis. Evidence summary would allow the researchers to record all primary
evidence condensing the information into meaningful syntheses (Khialani et al., 2020). The
research would synthesize the raw data on obese women and the contraception indications,
where new findings could be plausible. Translation of the material aims to provide the
practitioners with a document they can implement. Integration requires that practitioners
implement the findings and mitigation procedures they find as they perform the study (Khialani
et al., 2020). The researchers in the study would be inclined to suggest clinical practices that
prevent obese women from experiencing heightened risks in using contraceptive methods meant
to help them. Evaluating the material ensures that the EBP outcomes are desirable, or
implementation can positively change the quality of care and improve patient and provider
satisfaction.
4
Search Strategy and Levels of Evidence
The search strategy started with defining the research question, which was “Are obese
women ages 25 to 40 (P) who take oral contraceptives at greater risk (I) for developing blood
clots (O) compared with obese women ages 25 to 40 (P) who use IUDs for contraception (C)
over a 5-year time frame (T)?” The population included obese women of reproductive age. The
intervention studied was contraceptive use, and the comparison was oral or IUD use. The
outcome was a blood clot, and the study design was either randomized controlled trials,
observational studies, or reports published in English. A search for relevant keywords then
followed this. Keywords used included contraceptive, obesity, blood clot, deep vein thrombosis,
and pulmonary embolism. The search was done in different databases, including MEDLINE,
EMBASE, Cochrane Library, PubMed, CINAHL, Web of Science, and Scopus.
Through an online database search, 21 studies were obtained. It is also important to note
that some of these studies were obtained by searching through the reference lists of the already
obtained studies. After excluding all the duplicates and those not perfectly aligned with the
research topic, 12 studies remained. With further screening, including a full-text review of each
article, 6 studies were finally considered for review in this project (See Appendix). The Johns
Hopkins Nursing Evidence-Based Practice (JHNEBP) rating scale was adopted in evaluating the
references.
Literature Review
Current literature has indicated a connection between formation of blood clots and oral
contraception use. Rambaran and Alzghari (2020) have explored this topic extensively. This
systematic review was carried out by searching PubMed from inception to April 2018 for
relevant articles published in English. The results herein showed that obese women who used
5
oral contraceptives were at a higher risk than nonusers of developing blood clots (Rambaran &
Alzghari, 2020). This study explained the current statistics showing that over 400 women in the
US die every year related to their use of oral contraception (Rambaran & Alzghari, 2020).
The results are similar to findings by Khialani et al. (2020) who explored the relationship
between combined oral contraception and the risk of venous thromboembolism. The study is a
systematic review of 86 articles. The result of this study indicated that even though venous
thromboembolism is a considerably rare condition, the risk of obese women developing it
significantly increases when they use oral contraceptives (Khialani et al., 2020). Nonetheless,
different from other studies, the researchers assert that the benefits of the different oral
contraceptives in preventing pregnancies outweigh the risks for obese women (Khialani et al.,
2020). This study included a review of different studies, and for this reason, it was assigned a
rate of one on the JHNEBP rating scale.
Another study was carried out to update current knowledge on the relationship between
oral contraceptive pills and cerebral venous sinus thrombosis risk. The study also aimed to
examine the impact of other forms of hormonal contraceptives, duration, type, and health
condition of the woman on this relationship (Abdalhabib et al., 2022). This study was a
systematic review and meta-analysis in which a search was performed to identify a series of
published articles on the relationship between the use of hormonal contraceptives and the risk of
blood clots among obese women between 15 and 50 years of age (Abdalhabib et al., 2022). The
researchers reviewed only 11 of the 861 studies identified from the search. The results of this
review show that using oral contraceptive pills significantly increases the risk of obese women of
reproductive age developing cerebral venous sinus thrombosis (Abdalhabib et al., 2022).
However, the researchers quickly note that the available data remains inadequate to draw
6
definitive conclusions regarding how the duration of the use of contraceptives affects this
relationship. On the JHNEBP rating scale, this study was rated one since it extensively reviewed
data from other studies.
LaVasseur et al. (2022) conducted a study to examine the differences in the risk of
thrombosis in different methods of contraception and their interaction with different patientcentered factors. This study was based on the understanding that different methods of
contraception have been closely linked to venous thromboses. This study involved conducting a
narrative review of a series of studies regarding contraceptives and the risk of blood clots
(LaVasseur et al., 2022). The study results indicated that different contraceptive types have
different risk levels of blood clots for obese women. This is based on the idea that these women
have a higher body mass index while alone is a risk factor for blood clots (LaVasseur et al.,
2022). However, the risk even increases because oral contraceptives contain hormones that
increase the risk of blood clots, more so in women with other risk factors such as a family history
of blood clots, smoking, or obesity. Since this study was a systematic review, it was assigned a
score of one on the JHNEBP rating scale.
Analysis of Literature
Abdalhabib, E. K., Jackson, D. E., Alzahrani, B., Elfaki, E., Hamza, A., Alanazi, F., Ali, E.
I., Algarni, A., & Ibrahim, I. (2022). Assessment of risk factors for deep vein
thrombosis associated with natural anticoagulants and fibrinolytic regulatory
proteins. Blood Coagulation & Fibrinolysis, 33(3), 149–152.
https://doi.org/10.1097/mbc.0000000000001116
The article investigates deep vein thrombosis (DVT) as a critical disease in Africa by
investigating its risk factors paying attention to its natural anticoagulants and fibrinolytic
regulatory proteins. The study is designed to understand the specific roles these regulatory
proteins play in the development of the disease among the Sudanese. A case-control study was
utilized which is level II on the JHNEBP rating scale and a suitable design when investigating
7
this kind of problem. The findings presented would have been more convincing if data had been
collected from more than one facility for the indicated year. The researchers also investigated
the right parameters descriptive of deep vein thrombosis in terms of its regulatory proteins. In
this study, 5.5% of the participants were determined to have Protein C deficiency and 8.5% of
participants were victims of protein S deficiency. 3% were diagnosed with antithrombin III
deficiency. The findings also demonstrate that early assessment of risk factors is important in
improving treatment outcomes of DVT. Overall, the article is straightforward and precise in the
way information is presented.
LaVasseur, C., Neukam, S., Kartika, T., Bannow, B. S., Shatzel, J., & DeLoughery, T. G.
(2022). Hormonal therapies and venous thrombosis: Considerations for prevention
and management. Research and Practice in Thrombosis and Haemostasis, 6(6),
e12763. https://doi.org/10.1002/rth2.12763
The article by LaVasseu et al., 2022, seeks to investigate venous thrombosis as one
complication of hormonal therapy. The study pays attention to the risk of developing thrombosis
in persons using hormonal contraceptive agents. The researchers used a narrative review is data
collection which is an ideal method considering that challenges experienced when collecting data
on hormone-related thrombosis risks. The results indicate that thrombosis risk tends to increase
with an increment in oestrogen dosage. Thrombosis rates increase with age in women aged
above 30 years with an incidence rate of 2–3.7 events/10 000 women using oestrogen and
increases 10.2 times in women using third generation contraceptives. However, the study does
not identify effective management of complications of hormone therapy in patients diagnosed
with prothrombotic illnesses. Also, the article is a narrative review, placing it a level V, the
lowest on the JHNEBP rating scale which is very low quality of evidence.
Rambaran, K., & Alzghari, S. K. (2020). Gamer’s thrombosis: A review of published
reports. Ochsner Journal, 20(2), 182–186. https://doi.org/10.31486/toj.19.0058
8
This article investigates thrombosis as a common condition reported in elderly people
that develops in healthy adolescents. Published articles were reviewed to collect relevant data on
the relationship of immobility and increased risk of developing the VT. 12 out of the 26 articles
used in this study revealed instances where immobility led to the development of venous
thromboembolism, where 2 were fatalities reported. 15 patients were also determined to have
recurrent VT. The risk of developing VT was identified to be 2.33 for obesity which represents a
confidence interval of 95%. These results obtained confirm that immobile people are at a high
risk of developing thrombosis. Obesity, use of birth control and cigarette smoking are some risk
factors identified that can easily be modified. The recommendation for screening for venous
thromboembolism in gamers is justifiable owing to the prolonged sitting hours. The main
limitation of the study is that it is a level V evidence literature review, presenting low quality of
evidence.
Rosano, G. M., Rodriguez‐Martinez, M. A., Spoletini, I., & Regidor, P. A. (2022). Obesity
and contraceptive use: Impact on cardiovascular risk. ESC Heart Failure, 9(6),
3761-3767. https://doi.org/10.1002/ehf2.14104
The article considers obesity and contraceptives containing oestrogen as confirmed risk
factors for cardiovascular disease. The study uses a narrative review making it possible to
identify the latest research, current research and contentious issues about overweight and
cardiovascular risk. The results confirm that overweight women using oral contraceptives are 1224 times more likely to have venous thromboembolism comparing them with non-obese women
that are not on contraceptives. Specifically women using combined oral contraceptives with a
BMI index above 25 had the VT risk increased by 12-fold. These findings reveal the importance
of clinicians considering the body weight and BMI indexes of a person when administrating
contraceptives containing estrogen. Overall, the article is specific in its highlight of the dangers
9
of oral contraceptives for obese women but is a narrative review (Level V evidence rating) which
makes it low quality evidence.
Sultanmuratova, G. U., Babadjanova, G. S., Nazarbayev, J. B., & Kerimova, N. M. (2022).
A safe and effective contraceptive method for women with obesity in the postpartum
period. American Journal of Medicine and Medical Sciences 12(8): 836-839.
https://doi.org /10.5923/j.ajmms.20221208.15
This article investigates the safety levels of using drospirenone-containing combined oral
contraceptive in women of reproductive age determined to be overweight. The study used an
appropriate inclusion criterion in selecting sixty five obese women participants on
contraceptives. 39 participants were diagnosed with polycystic ovary syndrome. These are fertile
women who cannot ovulate. 32 people showed clinical signs indicating that they were infertile
while 22 had functional hyperprolactinemia. The study indicates that oral contraceptives pose a
major risk in complications of young women’s reproductive system. This study is a high
evidence rating (level II) as it is a quasi-experimental study.
Khialani, D., Rosendaal, F., & van Hylckama Vlieg, A. (2020, November). Hormonal
contraceptives and the risk of venous thrombosis. In Seminars in Thrombosis and
Hemostasis 46(8), 865-871. https://doi.org/10.1055/s-0040-1715793
The article by Khialani et al. (2020), seeks to reveal how the risk of developing venous
thrombosis (VT) is influenced by the kind of progestogen contained in oral contraceptives. The
study considers that the component ethinyl estradiol has counteracting effects that minimize the
chances of developing VT. The findings create a good understanding of how novel oestrogens
are developed and determined to have a reduced risk of VT. The study succeeds to reveal the
VT risk of combined oral contraceptives but fails to identify the risks associated with other
methods such as injectable contraceptives and vaginal rings. Other risk factors were identified.
Inherited thrombophilia is an underlying condition indicated to increase the susceptibility to VT
in women using combined oral contraceptives. The incidence rate of VT is 0.36% in cases of
10
mild thrombophilia and 0.64% in severe cases. It is unfortunate that the authors did not research
VT risk in women who switch combined oral contraceptives. The article is a narrative review of
the literature and hence a low level (level V) of evidence. In general, the researchers are justified
by suggesting the importance of identifying high-risk women to recommend alternative
contraception methods.
PICO Solution
Current evidence has highlighted a connection between oral contraception and the risk of
blood clots in obese women. All the studies included in the review have reported a statistically
significant correlation between oral contraception and blood clots such as venous
thromboembolism. The most reliable study is by Khialani et al. (2020) who conducted a
systematic review of 86 articles and reported a positive correlation. These findings indicate that
women of child-bearing age who have obesity and use oral contraception are at higher risks of
blood clots and cardiovascular events. Therefore, the evidence confirms the hypothesized
relationship in the PICO question.
The findings indicate the need for clinical changes in how contraception options are
presented to women. The proposed approach is a clinical guideline for contraception in
considering cardiovascular risks. In women seeking contraception assistance, providers should
assess their BMI to determine whether they are overweight or obese. If they fit in that category,
then the provider should advise on using non-hormonal contraception options such as IUDs. The
ultimate decision on the contraception to use will be made by the patients but providers should
provide education on risks associated and provide alternative contraception methods.
In line with the ACE Star model, the proposed solution reflects the translation to practice
and implementation stages. The proposed solution is a clinical practice guideline for providers
11
working with women in reproductive health. Summary of the evidence (step 2) has shown the
importance of prioritizing non-hormonal methods for obese women and this can be translated to
practice as a guideline (step 3) and implemented through patient education and counselling (step
4). The PICO solution and proposed implementation have been reached through a systematic
process for evaluating the evidence and reaching a conclusion for changes in practice. The
proposed solution, therefore, reflects the EBP process in line with the ACE star model.
Conclusion
The risk of cardiovascular events in people with obesity has long been identified but
other factors may aggravate this risk. The EBP project sought to explore the literature on
hormonal oral contraception and cardiovascular risks in women with obesity. To accomplish the
task, the research was based on the ACE star EBP model and a literature review conducted. Six
articles were included in the review focusing on blood clots risks for oral and IUD contraception.
The evidence shows that women experiencing obesity have a higher risk of blood clots if they
use oral hormonal contraceptives compared to IUDs. These findings confirm the hypothesized
relationship of hormonal contraceptives being associated with increased cardiovascular risks.
This project and findings present significant implications for reproductive healthcare.
Providers and nurses in reproductive care should consider the health risks associated with
contraception methods for their patients. Specifically, professionals should assess patients’ BMI
to determine if they are obese and for obese women, recommendations should be made on
appropriate contraception methods. Healthcare professionals have a responsibility to promote
patients’ safety and best health outcomes. Considering potential health effects of contraception
on the patients is important in ensuring this responsibility is met.
12
References
Abdalhabib, E. K., Jackson, D. E., Alzahrani, B., Elfaki, E., Hamza, A., Alanazi, F., Ali, E. I.,
Algarni, A., & Ibrahim, I. (2022). Assessment of risk factors for deep vein thrombosis
associated with natural anticoagulants and fibrinolytic regulatory proteins. Blood
Coagulation & Fibrinolysis, 33(3), 149–152.
https://doi.org/10.1097/mbc.0000000000001116
Khialani, D., Rosendaal, F., & van Hylckama Vlieg, A. (2020, November). Hormonal
contraceptives and the risk of venous thrombosis. In Seminars in Thrombosis and
Hemostasis 46(8), 865-871. https://doi.org/10.1055/s-0040-1715793
LaVasseur, C., Neukam, S., Kartika, T., Bannow, B. S., Shatzel, J., & DeLoughery, T. G. (2022).
Hormonal therapies and venous thrombosis: Considerations for prevention and
management. Research and Practice in Thrombosis and Haemostasis, 6(6), e12763.
https://doi.org/10.1002/rth2.12763
Manrique-Acevedo, C., Chinnakotla, B., Padilla, J., Martinez-Lemus, L. A., & Gozal, D. (2020).
Obesity and cardiovascular disease in women. International Journal of Obesity, 44(6),
1210-1226. https://doi.org/10.1038/s41366-020-0548-0
Rambaran, K., & Alzghari, S. K. (2020). Gamer’s thrombosis: A review of published reports.
Ochsner Journal, 20(2), 182–186. https://doi.org/10.31486/toj.19.0058
Rosano, G. M., Rodriguez‐Martinez, M. A., Spoletini, I., & Regidor, P. A. (2022). Obesity and
contraceptive use: Impact on cardiovascular risk. ESC Heart Failure, 9(6), 3761-3767.
https://doi.org/10.1002/ehf2.14104
Sultanmuratova, G. U., Babadjanova, G. S., Nazarbayev, J. B., & Kerimova, N. M. (2022). A
safe and effective contraceptive method for women with obesity in the postpartum
13
period. American Journal of Medicine and Medical Sciences 12(8): 836-839.
https://doi.org /10.5923/j.ajmms.20221208.15
14
Appendix
Citation of
Objective,
Search
Inclusion/Exc
Data
SR
Aim, Purpose
Strategy
lusion
Criteria
Results
Recommenda
Level of
Extraction
tion/
Evidence
and Analysis
Implication
LaVasseur, C., the differences Large
Thematic
Different
When
Neukam, S.,
in thrombosis
pharmacy
analysis
types of
contemplating
Kartika, T.,
risk of the
databases,
contraceptives
contraception,
Bannow, B.
many
biomarker
have different
clinicians
S., Shatzel, J.,
hormonal
studies,
levels of risk
must factor in
&
preparations
centralized
of blood clots
different
DeLoughery,
available and
hospital
for obese
prothrombotic
T. G. (2022).
their
registries,
women.
risk factors to
Hormonal
interaction
cohort studies,
make more
therapies and
with patient‐
and case-
informed
venous
specific
control studies
decisions
thrombosis:
factors.
Level 1
15
Consideration
s for
prevention
and
management.
Research and
Practice in
Thrombosis
and
Haemostasis,
6(6), e12763
Khialani, D.,
from inception of objectively
Switching
It is important
Rosendaal, F.,
Understanding to April 2018
confirmed
COCs, even
to identify
& van
hormonal
venous
when
women at risk
Hylckama
contraceptives
thrombosis in
switching
of VT and
Vlieg, A.
and the risk of
healthy
from a high-
advise them
Level 1
16
(2020,
venous
women taking
to a low-risk
on alternative
November).
thrombosis
oral
COC,
contraception
contraceptives
increases the
methods.
Hormonal
contraceptives
and the risk of
venous
thrombosis. In
Seminars in
thrombosis
and
hemostasis
(Vol. 46, No.
08, pp. 865871). Thieme
Medical
risk of VT
17
Publishers,
Inc…
Abdalhabib,
To assess the
A search
Factors for
Thematic
The early
Risk factors
E. K.,
roles of
through PMC
deep vein
analysis
assessment of
should be
Jackson, D.
natural
thrombosis
risk factors,
assessed early
E., Alzahrani,
anticoagulants
associated
including the
enough to
B., Elfaki, E.,
and
with natural
measurements
prevent
Hamza, A.,
fibrinolytic
anticoagulants
of natural
occurrence of
Alanazi, F.,
regulatory
inhibitors, can
DVT
Ali, E. I.,
factors in the
predict the
Algarni, A., &
development
occurrence of
Ibrahim, I.
of DVT in
DVT before it
(2022).
Sudanese
is actually
Assessment of
patients.
detected in
risk factors for
patients.
LevelI
18
deep vein
thrombosis
associated
with natural
anticoagulants
and
fibrinolytic
regulatory
proteins.
Blood
Coagulation &
Fibrinolysis,
33(3), 149–
152.
https://doi.org/
10.1097/mbc.
19
00000000000
01116
Rambaran, K.,
To explore the
PubMed,
Thematic
Modifiable
Strongly
& Alzghari, S.
relationship
Scopus, Web
analysis
risk factors
encourage
K. (2020).
between
of Science,
included
screening
Gamer’s
combined oral
and EBSCO
cigarette use,
gamers for
thrombosis: A
contraception
for articles
being
possible VTEs
review of
and the risk of
overweight,
if clinically
published
venous
birth control
warranted.
reports.
thromboembol
use, and
Ochsner
ism
prolonged
Journal, 20(2),
immobility.
182–186.
Anticoagulatio
https://doi.org/
n was the
principal
Level 1
20
10.31486/toj.1
treatment
9.0058
modality in
patients
presenting
with gaming
thrombosis
Rosano, G.
Discuss the
The electronic
Cardiovascula
Exercise
M.,
latest
database
r risks, mainly
caution with
Rodriguez‐
evidence,
search in
VTE risks,
the use of
Martinez, M.
ongoing
PubMed
increase
COCs in
A., Spoletini,
research, and
between 12
patients with
I., & Regidor,
controversial
and 24 times
overweight
P. A. (2022).
issues on the
compared
and obesity,
Obesity and
synergistic
with non-
choosing the
contraceptive
effect of
obese non-
safest
use: impact on
obesity and
COC users.
alternatives
Level II
21
cardiovascular
contraceptive
when
risk. ESC
use in terms of
prescribing
heart failure.
cardiovascular
hormonal
risk
contraception
due to the
rising global
prevalence of
obesity.
Sultanmuratov This study
The electronic
The study
According to
Additional
a, G. U.,
aims to
database
included 65
the study
control should
Babadjanova,
determine the
search in
women of
results, a
be carried out
G. S.,
safety of
PubMed
reproductive
favorable
in patients
Nazarbayev, J. drospirenone-
age who were
effect of low-
with impaired
B., &
containing
prescribed OC
dose OC pills
carbohydrate
Kerimova, N.
combined oral
with 30 µg of
on body
metabolism.
M. (2022). A
contraceptives
ethinyl
weight and
Level II
22
safe and
(OC) in
estradiol and 3 lipid profile
effective
overweight/ob
mg of
was revealed
contraceptive
ese women of
drospirenone
without
method for
reproductive
for 3 months
significant
women with
age.
for therapeutic
changes in
obesity in the
and preventive carbohydrate
postpartum
purposes. The
metabolism. C
period.
main
onclusion. Th
American
parameters
erefore, this
Journal of
evaluated
method of
Medicine and
were lipid and
contraception
Medical
carbohydrate
may be
Sciences
metabolism
recommended
2022, 12(8):
for
836-839.
overweight/ob
https://doi.org
ese patients to
23
/10.5923/j.ajm
control
ms.20221208.
fertility in the
15
postpartum
period.
1
[Insert Title here]
[Insert Names of Author(s) here]
Texas Woman’s University
As a student you are responsible for utilizing the appropriate TWU coversheet, rubric and
current APA edition at the time of your submission. This paper is only a sample and not all
inclusive, but to be used as a guide.
2
[Insert Title here]
This paragraph should be your Introduction. Your introduction follows the title of your
paper (note that title is not bolded). You should start your introduction with a powerful statement
or two to stimulate interest.
You should identify the purpose of your paper and provide a preview of what the paper
will include. Remember that formal papers are in third person. In setting up your paper, you
should introduce the clinical question in PICO or PICOT format. You should define each of
these (Population, Intervention, Comparison, Outcome, Timeframe).
Significance of the Problem (FNP I)
This section should answer the question “why is this important?” You may support this
problem through examples from your own experience and clinical practice. It may be beneficial
to include incidence/prevalence or other appropriate data in order to establish relevance and
urgency. Be sure to add any supportive clinical guidelines or references as appropriate. Review
rubric for specifics.
Theoretical Model (FNP I)
ACE Star Model. See Rubric for a more thorough explanation of what is needed here
Search Strategy and Results (FNP II)
This section should include your search words and terms, the databases used along with
the results in those databases for each word or term, and inclusion and exclusion criteria. The
reason for exclusion of a study that meets your inclusion criteria needs to be explained either by
your exclusion criteria (e.g., English, adults, humans) or your inability to obtain the article
despite your best efforts. You should summarize the final result by identifying the number of
studies in each category (e.g., # of RCTs, # of qualitative studies, # of cohort studies, # of
3
systematic reviews, etc.). This can be achieved through the use of a figure so you can provide a
brief summary and then refer the reader to the figure.
Level of Evidence (FNP II)
Level of evidence hierarchy that is used for this paper.
Literature Review (FNP II)
Evaluate the chosen literature as a whole in relation to your stated problem, grouping
the articles into similar categories and examining the strengths and weaknesses of the literature
review and how it either supports or does not support your stated problem. Keep in mind that
the articles in this section should be research studies or systematic reviews, not summary
articles. This is all about the evidence rather than someone else’s opinion of the evidence. Do
not use secondary sources; you need to get the article, read it, and make your own decision
about quality and applicability to your question even if you did find out about the study in a
systematic review. You will need to define what evidence rating scale you are using (SORT,
Johns Hopkins Nursing Evidence-Based Practice Rating Scale, American Medical Association
(AMA), etc.)
When writing about a study you should include at minimum the study design, setting,
sample, and evidence rating. Do NOT address each study and give a summary. Your summary
table of evidence (Appendix A/B) will do that. Discuss the “high points” in this review. Call out
the most significant data that helped or that you think will help you decide whether or not to
change a practice.
Finally, the studies in this section MUST relate directly to your PICOT question.
Conclude with a summary statement regarding the strength of your evidence. So. . . what is the
answer to your question?
4
Analysis of Literature (FNP III)
Evaluate the chosen literature as a whole in relation to your stated problem. DO NOT
simply restate the information in your table or from the previous review. You should group
articles into similar categories examining overall strength and weakness. This section should
support your conclusion. This is the “So what” part of the paper. Is there enough information
to suggest/enact a change? If not, what can/should be done?
Clinical Implication (PREC II)
Clearly interpret the answer and outcome to your PICO question by utilizing your
research findings. How or in what ways is your PICO and solution relevant in clinical practice?
How will your solution be implemented in clinic (must be specific and integrate theoretical
model you chose)?
Conclusion
The conclusion should start with a statement regarding the intention of the paper and
your achievement toward that intention. Also, it should briefly say what was included in the
paper. The outcome of the literature review and analysis should clearly be linked to the problem.
Discuss how you plan to use the results of this review of literature in relation to your stated
problem. Remember that the introduction is a preview, and this section should contain a
summary. This section should logically “set up” your implementation plan which is part of the
Clinical Project Paper required next semester.
5
References
[Insert Reference List here]
Remember that this is a reference list rather than a bibliography. A bibliography is everything
you read to prepare the paper, but a reference list is only what you cited. If there is not a citation
for a reference, it should not be here.
6
Appendix A (FNP II)
Summary of Primary Sources of Evidence
Citation of
Evidence
Legend:
Study Question or Study Design
Hypothesis
Sample/Setting
Independent and Data Collection & Findings
Dependent
Analysis
Variables & Tools
Used
Recommendation/ Level of
Implications
Evidence
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Appendix B
