Treatment Fidelity

USE THE ARTICLE TO ANSWER THESE QUESTIONS

Instructions:  Using the discussion and decisions your group has made during the Module 5 discussion board, write and submit a draft of the following portions of your final paper.  I suggest that you spread out the work among your team members or rotate the responsibility for each week.

A weekly drafts example is attached.  Module 4 DB/Module 5 Draft sample paragraphs are highlighted in yellow; Module 5 DB/Module 6 Draft sample paragraphs are highlighted in green; and Module 6 DB sample paragraphs are highlighted in blue (you will not submit a draft for the Module 6 DB work). Of course, the synopsis portion will be specific to your article, and the appraisal portion should include application of all concepts relevant to your article.

Synopsis:  Write a study synopsis that includes these main points.

  • how the study was conducted
    • describe the intervention and procedures for carrying it out
    • include measurement instruments and what they measured
    • procedures for collecting the data

Appraisal: Appraise the article in narrative format by answering the following questions.

  • Was treatment fidelity accomplished?  Why or why not?
  • Were the measurement instruments reliable and valid? Why or why not?
  • Were the conclusions of the study supported by the results?  Why or why not?
    • Include key statistical results and p-values, if provided, as part of your rationale.

Cardiovascular Critical Care
©2021 American Association of Critical-Care Nurses
doi:https://doi.org/10.4037/ajcc2021687
Background For women undergoing median sternotomy,
especially those with a bra cup size C or larger, breast
support can reduce pain, wound breakdown, and infection.
This study addressed a gap in research, identifying the
best bra after sternotomy in terms of patient satisfaction
and wear compliance.
Objectives To evaluate larger-breasted women’s satisfaction and compliance with wearing 3 commercially available
front-closure bras—with a hook-loop closure (the hospital’s
standard of care), a zipper closure, or a hook-eye closure—
after cardiac surgery.
Methods This study used a posttest-only, 3-group randomized controlled design. A convenience sample of participants were sized and randomly assigned a product that
was placed immediately postoperatively. Participants agreed
to wear the bra at least 20 h/d until the provider cleared them
for less wear. At inpatient day 5 or discharge, and at the
follow-up outpatient visit, subjects completed investigatordeveloped surveys. Data were analyzed from 60 participants
by using the r2
test and Kruskal-Wallis analysis of variance;
also, patterns were identified within written comments.
Results Participants were most satisfied with the hook-eye
front-closure product before (P = .05) and after (P = .02) discharge.
Participants recommended the hook-eye and zipper products over the hook-loop bra (H = 8.39, P = .02). Wear compliance was strongest in the group wearing the hook-eye bra.
Conclusions The hook-eye closure product had the most
satisfaction and greatest wear compliance, and it received
the highest recommendation. A practice change was made
to fit and place the hook-eye bra in the operating room
immediately after surgery. (American Journal of Critical
Care. 2021;30:21-26)
www.ajcconline.org AJCC AMERICAN JOURNAL OF CRITICAL CARE, January 2021, Volume 30, No. 1 21
1.0 Hour C E
This article has been designated for CE contact
hour(s). See more CE information at the end of
this article.
BRAS FOR BREAST
SUPPORT AFTER
STERNOTOMY: PATIENT
SATISFACTION AND
WEAR COMPLIANCE
By Kimberly Bolling, BSN, RN, CCRN, Takako Long, BSN, RN, Cathy D.
Jennings, DNP, RN, ACNS-BC, Francis C. Dane, PhD, and Kimberly Ferren
Carter, PhD, RN, NEA-BC
22 AJCC AMERICAN JOURNAL OF CRITICAL CARE, January 2021, Volume 30, No. 1 www.ajcconline.org
Previous research confirms that women, especially those with larger breasts, can benefit
from external breast support after cardiac surgery via median sternotomy.1
Normally,
breast tissue without support moves in all directions when a female participates in
minimal activity.2
Simple walking and running can displace the breast vertically,
mediolaterally, and anteroposteriorly.2,3
A midchest incision in a patient with large
breasts further increases the need for a supportive
garment to decrease wound tension. Tension at the
midline sternotomy incision site has been directly
linked to macromastia (defined as breasts large
enough to require a bra cup size C or larger),4
which
places the patient undergoing cardiac surgery at an
increased risk for both sternal wound infection4-7
and postoperative pain, especially during the early
recovery period.8,9 Use of a supportive bra may
reduce this risk.4-5,9
Many female patients undergoing cardiac surgery are reluctant to discuss their breast support and
breast pain issues with their care providers.10 In one
study, most women were surprised by and unprepared
for the breast pain they experienced after sternotomy
and did not know how to manage breast symptoms.10
Further, care providers may
not acknowledge or address
breast issues when teaching
women how to care for
themselves after discharge
from the hospital after cardiac surgery.10 Early during
the postoperative period,
the healing midchest incision site and drainage tubes
can also impact use of a bra. Care providers may
not advise these patients to wear a bra immediately
postoperatively because regular bras interfere with
nursing care11; however, King et al,2
in the Women’s
Recovery from Sternotomy-Extension (WREST-E) study,
suggested the importance of consistent education
about and reinforcement of the need for a comfortable
and supportive bra after surgery. Brocki et al12 suggested actually placing the bra on the patient at the
end of the surgery, which ensures breast support
soon after closure of the skin incision.
The optimal bra for wear after sternotomy closes
in the front, because moving both arms around the
back simultaneously can cause incisional (and sternal) tension.12 Second, and perhaps most important,
the optimal bra is both comfortable and supportive.
If a woman is dissatisfied with the bra, she may consciously decide not to wear the garment regardless of
its importance or necessity.
Although researchers have explored the effect of
a supportive bra on pain reduction, functional status,
infection at the surgical site, and sternal wound healing in this population,7,9,11 we found only 1 study that
elicited feedback from both patients and nurses regarding a particular postoperative bra—in this case, one
that aimed to help prevent pressure ulcers.13 In a bestevidence review of 6 randomized controlled trials of
postoperative external support devices,14 only 1 study
specifically evaluated the effectiveness of a postoperative bra in reducing pain and promoting sternal healing in female patients.11 We found no recent research
that focused on a patient’s satisfaction with a commercially available bra and compliance with the provider’s instructions for wear after sternotomy.
Consequently, we designed this study to answer
the question, Which of 3 commercially available
breast support products—standard-of-care hookloop bra (similar to Velcro brand ), zipper bra, or
hook-eye bra (Figure 1)—results in the greatest user
satisfaction and wear compliance? This study contributes to the limited knowledge base regarding the type
of product that will both satisfy larger-breasted women
after sternotomy and yield optimal wear compliance
among patients after sternotomy.
Methods
Design, Setting, and Participants
This study was approved by the institutional
review board at Carilion Clinic and was conducted in
accordance with that board’s standards and the ethical standards set forth in the Declaration of Helsinki.
The study used a 3-group, posttest-only randomized,
controlled, longitudinal design. It was conducted
About the Authors
Kimberly Bolling is a registered nurse in the cardiac surgery intensive care unit and Takako Long is a registered
nurse in the cardiovascular progressive care unit, Carilion
Roanoke Memorial Hospital, Roanoke, Virginia. Cathy D.
Jennings is a clinical nurse specialist, Carilion Roanoke
Memorial Hospital. Francis C. Dane is a professor of psychology, Radford University, Radford, Virginia, and a professor
of interprofessionalism, Virginia Tech Carilion School of
Medicine, Roanoke, Virginia. Kimberly Ferren Carter is senior
director, nursing research, Carilion Clinic, Roanoke, Virginia.
Corresponding author: Kimberly Bolling, BSN, RN, CCRN,
Carilion Roanoke Memorial Hospital, 1906 Belleview Ave,
Roanoke, VA 24014 (email: kabolling@carilionclinic.org).
Many women undergoing cardiac surgery are
reluctant to discuss
their breast issues with
their providers.
www.ajcconline.org AJCC AMERICAN JOURNAL OF CRITICAL CARE, January 2021, Volume 30, No. 1 23
from June 1, 2016, through June 8, 2017. The study
took place at a 703-bed academic medical center in
the southeastern United States; the center’s cardiovascular institute has been providing cardiac surgical
services since 1982 and performed more than 500
cardiac surgical procedures in 2017. During the study
period, the institute featured 4 cardiac surgery operating rooms, an 11-bed cardiac surgery intensive care
unit, and a 25-bed progressive care unit.
Eligible study participants were women (≥18 years
old) who were not pregnant and were undergoing
nonemergent cardiac surgery via median sternotomy.
They had no history of chest radiation, breast reduction, mastectomy, or median sternotomy; wore a minimum of a C-cup bra size; spoke English; and were able
to verbalize their understanding of the study. The product to which a participant was randomized had to be
available in her measured bra size (hook-loop bra
[Surgical Bra, DeRoyal Industries]: 36.0-55.0 in; zipper bra [Genie Zip bra; TriStar Products]: 39.0-52.5 in;
hook-eye bra [Carefi x Mary bra; Tytex]: 32.0-54.0 in).
The participants were asked to wear their bra for a
minimum of 20 h/d, removing it only to bathe or
to launder it.
Instruments
Outcome measures included satisfaction before
and after discharge and wear compliance after discharge. The literature we reviewed included no measures for these outcomes; therefore, we developed
measures for use. Satisfaction with the bra before
discharge was measured on postoperative day 4 or 5
by using a question about satisfaction (self-report);
results ranged from 1 to 10 (1 = completely dissatisfi ed, 10 = completely satisfi ed). The survey after discharge included the same satisfaction item, a question
about whether the participant would recommend
the bra to other women undergoing sternotomy
(rating scale, 1 = defi nitely would not recommend to
5 = defi nitely would recommend), a question about
the amount of time the bra was worn after discharge
(compliance), and an opportunity to provide any
comments about the product. The postdischarge
survey was administered at the follow-up offi ce
visit, which generally occurred between 20 and 40
days after surgery.
Protocol
We reviewed the daily surgery schedule to identify
potential study participants. We screened inpatients
who were currently hospitalized and outpatients
who were visiting the center’s presurgical testing clinic.
Then, study team members requested assistance from
each patient’s nurse to determine whether the patient
would be interested in receiving information about
the study. If the patient was interested, a study team
member met with her and provided both information about informed consent and a written study
information sheet.
After confi rming that all of the patients’ questions
had been addressed and obtaining their verbal consent
to participate (the institutional review board had
granted a waiver of signed consent), a member of
the research team measured the participant’s chest/
band and cup sizes. Participants were randomized to
1 of the 3 product groups (hook-loop bra [the hospital’s standard of care], zipper bra, or hook-eye bra)
through the use of a random numbers table. If a participant was randomized to wear a bra that was not
available in her size, she was excluded from the study
and was given the standard of care (the hook-loop
bra). If the selected product was available in the participant’s size (on the basis of the manufacturer’s
sizing recommendations), the appropriately sized
product was delivered to the cardiac surgery operating room on the day of the procedure. The staff in the
operating room applied the bra to the patient at the
end of surgery, before she was transferred to the cardiac surgery intensive care unit.
Sample Size
We calculated effect size using the estimation
approach described by O’Brien and Muller15 for
analysis of variance studies. On the basis of estimates of between-means variance (1/33) and
within-group SD (1.49), and using a rating of
satisfaction between 1 and 10 for 2-way analysis
of variance, we estimated an effect size of 0.6.
Using this estimated effect size, a power of 0.80,
Figure 1 Sample bra products (left to right): DeRoyal Industries
Surgical Bra (hook-loop closure; similar to Velcro brand), TriStar
Products Genie Zip (zipper closure), Tytex Carefi x Mary (hookeye closure).
24 AJCC AMERICAN JOURNAL OF CRITICAL CARE, January 2021, Volume 30, No. 1 www.ajcconline.org
and an _ of .05, we deemed a sample size of 20
participants per group to be sufficient.
Statistical Analysis
We used SPSS version 25 for statistical analysis.
Because none of the measures were normally distributed, we use the Kruskal-Wallis analysis of variance, and we report median values and interquartile
ranges for continuous variables. We used the r2
test
for categorical variables.
Analysis of Written Comments
We also analyzed participants’ comments about
the bra they received. Three independent coders (K.B.,
K.F.C., C.D.J.) categorized the qualitative data, and
discrepancies were resolved through discussion
among all coders until consensus was reached.
Results
Participants
Of the 97 patients assessed for eligibility for
inclusion in this study, 28 did not meet the inclusion criteria; 69 patients consented to participate
and were randomized (Figure 2). The zipper product
did not come in a large enough size for 3 patients,
who were removed from the study and given the
standard-of-care product. Six of the randomized
participants (1 in the hook-loop group, 2 in the zipper group, and 3 in the hook-eye group) were lost to
follow-up (they were intubated or sedated, which
affected their ability to communicate, or they died).
We included 60 participants in the final analysis; 20
participants were randomized to each group. The
study ran 53 weeks, ending when the 60th participant had been enrolled and had completed the postdischarge survey. No harm or unintended effects
occurred in any group. The 3 groups were demographically similar (Table 1).
Satisfaction With Bra
On postoperative day 5 or the day of discharge
(whichever occurred first), we found significant differences in patients’ satisfaction with the various
products (H = 5.88, P = .05). Participants were less
satisfied with the hook-loop bra (satisfaction score
8.5 out of 10.0) than with the zipper bra (10.0) and
the hook-eye bra (9.5). This pattern of satisfaction
continued after discharge (H = 7.7, P = .02): participants were significantly less satisfied with the hookloop bra (7.0) than with the hook-eye bra (8.0);
satisfaction with the zipper bra (7.5) fell between
the other 2 (Figure 3). Participants recommended
the standard-of-care product (hook-loop bra; recommendation score 4.0 out of 5.0) significantly
less (H = 8.39, P = .02) than they did both the zipper
(5.0) and the hook-eye (5.0) products. The recommendation rating varied most for the hook-loop bra
(interquartile range 4.0); for the other products, the
recommendation rating varied little (interquartile
range for both 1.0, P = .009).
Figure 2 CONSORT flow diagram for study enrollment.
Enrollment
Allocation
Follow-up
Analysis
Excluded (n = 28)
• Did not meet criteria (n = 28)
Patients assessed for eligibility (n = 97)
Randomized (n = 69)
Allocated to zipper front closure (n = 25)
• Received allocated intervention (n = 22)
• Did not receive allocated intervention
(bra not large enough; n = 3)
• Allocated to hook-eye front closure (n = 23)
• Received allocated intervention (n = 23)
• Did not receive allocated intervention
(n = 0)
Allocated to hook-loop front closure (site
standard; n = 21)
• Received allocated intervention (n = 21)
• Did not receive allocated intervention
(n = 0)
• Lost to follow-up (intubated/sedated;
n = 1)
• Discontinued intervention (n = 0)
• Lost to follow-up (intubated/ sedated;
mortality (n = 3)
• Discontinued intervention (n = 0)
• Lost to follow-up (intubated/sedated (n = 2)
• Discontinued intervention (n = 0)
• Analyzed (n = 20)
• Excluded from analysis (n = 0)
• Analyzed (n = 20)
• Excluded from analysis (n = 0)
• Analyzed (n = 20)
• Excluded from analysis (n = 0)
www.ajcconline.org AJCC AMERICAN JOURNAL OF CRITICAL CARE, January 2021, Volume 30, No. 1 25
Wear Compliance
We assessed participants’ compliance with wearing the bra during the postoperative period using
postdischarge reports of wear 7 days per week and
at least 20 hours per day. We found no significant
difference in wear compliance between the products
(r2
2
= 2.5, P = .29). The percentage of patients wearing the assigned bra as instructed, however, did vary
among the products (Table 2). The participants who
reported wearing the hook-eye product 7 days per
week also reported wearing it 24 hours per day. Four
participants—3 assigned the hook-loop bra and 1
assigned the zipper bra—did not wear the assigned
bra at all after discharge.
Qualitative Feedback
Respondents provided comments related to their
perceptions of the bra; the support it provided; malfunctions; and any rubbing, cutting, irritation, or comfort issues. The comments were consistent with the
results of the statistical analysis, indicating discomfort and rubbing with the hook-loop product and
malfunctions with the zipper product. Participants
also noted some rubbing with the hook-eye product.
Discussion
This study aimed to identify the best bra for
patients after sternotomy in terms of satisfaction and
wear compliance. The participants in this study were
least satisfied with the hook-loop front-closure bra, the
standard of care at the study site. They were most satisfied with the hook-eye closure bra and recommended
that bra and the zipper bra over the hook-loop bra.
The zipper product did not come in sizes for women
with very large breasts, and the zipper frequently
malfunctioned. With regard to wear compliance, none
of the participants wearing the hook-eye bra reported
not wearing the bra at all. Overall, wear compliance
was strongest in the group wearing the hook-eye bra.
On the basis of these findings, we have determined
that the hook-eye closure product yielded the most
satisfaction (it was given the highest recommendation)
and greatest wear compliance in this study.
The strengths of this study include the experimental design and the sample size, which is large
enough to provide sufficient statistical power. The
study contributes to the limited knowledge related to
bra selection to promote satisfaction and wear compliance. The limitations of the study include the lack
of availability of zipper products for women with very
large breasts (we had to exclude from the study such
women who had been randomized to the zipper product). The study was not powered to detect differences
in compliance. The findings supported a change in
practice: the hook-eye bra is now the product used
as the standard of care for this patient population
at the study site. In addition, the bra is placed immediately after surgery while the patient is still in the
operating room (a practice recommended by Rochon
et al7
), rather than later, after they have been moved to
the intensive care unit, which was the standard procedure at our site before the study.
This randomized trial is generalizable to samples
like the one used in this study. We did not include
in this study women with breasts smaller than a bra
cup size C; therefore, more work is needed in order
Variable
Table 1
Demographic variables by group
Chest size, mean
(SD), in
Cup size, %
C
D
DD
DDD
Body mass index,a
mean (SD)
PREVENA Incision
Management
System, % yes
.85
.21
.76
.36
39.9 (4.0)
60.0
35.0
5.0
0.0
28.6 (8.5)
42.1
0.15
(3.1)
0.56
(2.1)
39.0 (7.0)
38.9
50.0
11.1
0.0
30.2 (9.0)
30.0
39.4 (6.0)
66.7
27.8
0.0
5.6
28.1 (8.6)
52.6
Hook-eye H or (r P 2 Hook-loop Zipper )
a Calculated as weight in kilograms divided by height in meters squared.
Value in group
Figure 3 Satisfaction with bra before and after discharge. Satisfaction with bra
10
9
8
7
6
5
4
3
2
0
1
Hook-loop Hook-eye Zipper
Before discharge After discharge
Variable
Patients wearing product, %
Table 2
Wear compliance as a function of product
7 d/wk
24 h/d
(among those
wearing 7 d/wk)
.27
.17
89.5
100.0
2.59
3.53
70.0
85.0
84.2
94.7
Hook-eye r P 2 Hook-loop Zipper
26 AJCC AMERICAN JOURNAL OF CRITICAL CARE, January 2021, Volume 30, No. 1 www.ajcconline.org
to understand the best bra for women with smaller
breasts after sternotomy. Given that we used only 1
brand for each closure type, future investigations
should examine brand variability with regard to fit
and comfort. This study focused only on women,
but obese men with macromastia may require breast
support; this topic also warrants further study. Study
of new products would be beneficial as they emerge
on the market. Finally, more study is needed in order
to evaluate the approach of combining both a bra
and an external chest support device.
Conclusion
This study contributes to the currently limited
literature related to patients’ bra preference after
sternotomy. By promoting use of the bra that engenders the most satisfaction and wear compliance, nurses
can facilitate the availability and postsurgical application of the appropriate bra, thereby lessening a
patient’s risk for adverse effects—including infection,
healing issues, and pain—that are known to occur
when bras are not worn after sternotomy. Replication studies are warranted in different populations.
ACKNOWLEDGMENTS
This work was performed at the Cardiovascular Institute
of Carilion Roanoke Memorial Hospital. The study was
completed as a Carilion Nursing Research Fellowship.
The authors gratefully acknowledge the contributions
of Debra Pullen, BSN, RN, Sandy Wilson, RN, Sara Gill, BSN,
RN, Maria Cristofis, and Laura Kate Jennings, BA, all from
Carilion Clinic, Roanoke, Virginia.
SEE ALSO
For more about care after sternotomy, visit the Critical Care
Nurse website, www.ccnonline.org, and read the article
by Liu et al, “Topical Lidocaine Patch for Postthoracotomy
and Poststernotomy Pain in Cardiothoracic Intensive Care
Unit Adult Patients” (October 2019).
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Heart Lung. 1995;24(6):495-501.
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13. Cooper DN, Jones SL, Currie LA. Against all odds: preventing
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15. O’Brien R, Muller K. Unified power analysis for t-tests through multivariate hypotheses. In: Edwards L, ed. Applied Analysis of
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1.0 Hour Category B C E
Notice to CE enrollees:
This article has been designated for CE contact hour(s). The evaluation demonstrates your knowledge of the
following objectives:
1. Identify why bra selection and wear compliance is important for women after sternotomy.
2. Discuss strengths and limitations for various closure types of bras used for women after sternotomy.
3. Describe the type of bra closure that resulted in greatest user satisfaction and wear compliance for women
after sternotomy.
To complete the evaluation for CE contact hour(s) for this article #A21302, visit www.ajcconline.org and click
the “CE Articles” button. No CE evaluation fee for AACN members. This expires on January 1, 2023.
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