pre-surgical localization 1 running head: pre-surgical localization

Pre-Surgical Localization 1

Running head: PRE-SURGICAL LOCALIZATION

Pain Associated with Pre-Surgical Localization

of Non-Palpable Breast Lesions

William Lodrigues MS, WHNP-BC

Texas Woman’s University


Table of Contents

Page

Abstract ………………………………………………………………………………..….5

Introduction …………………………………………………………………………..…..7

Scope of Problem ………………………………………………………………....7

Population and Setting ……………………………………………………………9

Expected Outcomes ………………………………………………………..….….9

Definition of Terms …………………………………………………….…...…….9

Purpose …………………………………………………………………………………..10

Research Question ……………………………………………………………....11

Null Hypothesis …………………………………………………………………11

Theoretical Framework …………………………………………………………………11

Pain ……………………………………………………………………………...12

Lidocaine Hydrochloride ………………………………………………………..12

Review of Literature ………………………………………………………………….…13

Diagnostic Technologies ………………………………………………………..14

Wire Localization ……………………………………………………………….14

Pain Perception ……………………………………………………………….....15

Seed Localization ……………………………………………………………….17

Project Implementation and Results …………………………………………………….22

Objectives ……………………………………………………………………….22

Time Line ……………………………………………………………………….23

Setting……………………………………………………………………………23


Project Requirements ……………………………………………………………24

Sample………………………………………………………………………..…..24

Inclusion and Exclusion Criteria…………………………………………………25

Informed Consent Process……………………………………………………….25

Methodology………………………………………………………………….….25

Visual Analog Scale …………………………………………………..…………26

Evaluation of Objectives ……………………………………………………………...…27

Expected Results and End Products …………………………………………….28

Project Evaluation and Recommendations ……………………………………………...29

Plan for Evaluating Data …………………………………..…………………….29

Statistical Analysis ………………………………………………………………30

Discussion ……………………………………………………………………….32

Project Limitations ………………………………………………………………33

Future Recommendations ……………………………………………………….34

Conclusion ………………………………………………………………………………35

References ……………………………………………………………………………….36

Appendix

A University of Texas IRB Application........................................................41

B University of Texas IRB Approval Letter………………..…...…………53

C Texas Women’s University IRB Application.……………………….…..56

D Texas Women’s University IRB Approval Letter..........……….…....…..58

E Project Timeline.........................................................................................60

F Tool (English)……………………………………………………………62


G Tool (Spanish)………….………………………………………………...64

H Informed Consent……………………………………………………...…66

I Pain Scale…………...………………………………………………...….70

J Statistical Tables……………………………………………………...….72

1 Descriptive Statistics for Age and Pain Analyses…………….…73

2 Statistical Correlation....................................................................74

3 Statistical Correlation……………………………………………75


Abstract

Background

Pre-surgical localization of a non-palpable breast lesion has evolved through advances in

new technologies since the first documented wire localization in 1965. Several new methods of

pre-surgical localization of non-palpable breast lesions have shown great potential to improve

diagnosis and treatment of breast cancer. One new procedure developed at the Moffitt Cancer

Center utilizes a radioactive titanium seed to localize a non-palpable breast lesion. Radioactive

Seed Localization (RSL) has shown a significant reduction in re-excision rates, decreased

operative and anesthesia time, and decreased need for specimen radiographs. There is modest

data related to the pain perception associated with RSL in comparison to the traditional wire

localization and a lack of data comparing breast size in relation to pain perception during pre-

surgical localization procedures.

Method

A prospective study was conducted of 25 consecutive patients undergoing pre-surgical

localization of a non-palpable breast lesion utilizing RSL or wire localization at a large

Midwestern teaching hospital from October 30, 2009 to February 24, 2010. The surgical

oncology schedule was accessed to identify patients scheduled for pre-surgical localization of a

non-palpable breast lesion. All pre-surgical localization procedures were conducted by two

fellow trained radiologists utilizing identical protocols and local anesthesia. Patients completed

a one-page questionnaire after the localization procedure and prior to surgery. Data collected

included demographics, brassiere size, prior localization experience, pain history, and pain

perception. A visual analog pain scale measured perceived pain experienced. Statistical analysis


of pain between two localization procedures was conducted as well as statistical correlation

analysis of pain of the localization procedure and breast size.

Results

The average pain perception of patients post wire localization was 3.86 compared to 2.27

of patients post RSL and was non-significant (p = 0.158). The correlation between pre-surgical

pain and brassiere size was non-significant (p = 0.874).

Conclusion

The average pain perception score for RSL (2.27) was consistent with pain perception

scores in the literature utilizing similar visual analog scales. Although not significant, the mean

pain scores for RSL were lower than the pain scores of wire localization (2.27 versus 3.86; p =

0.158), consistent with the literature. The correlation between breast size and pain perception

was non-significant (p = 0.874). There was no indication that breast size or method of

localization should alter the amount of anesthesia administered prior to a localization procedure.

In comparison to wire localization, RSL exhibits no statistical difference in pain during

implantation and is proving to be a superior method to localize non-palpable breast lesions.


Pain Associated with Pre-Surgical Localization

of Non-Palpable Breast Lesions

Scope of Problem

In 2009 there were 194,280 new cases of breast cancer and over 40,000 deaths related to

breast cancer in the United States (National Cancer Institute, [NCI] 2009). Over 15,000 new

cases of breast cancer were reported in Texas in 2008, and breast cancer is the second leading

cause of cancer death of females (NCI, 2009; Cancer, 2009). The National Cancer Institute

(NCI) and the Surveillance, Epidemiology, and End Results (SEER) predict a 12.7% lifetime risk

of women to develop breast cancer (National Cancer Institute).

During the last 20 years, there have been great strides in mammographic technologies and

techniques to identify non-palpable breast lesions. Mammography can now detect 85% of

asymptomatic breast cancers, which include those cancers that are not palpated and noted only

through sonography or mammography. (Kerlikowske & Barclay, 1997; United States Food and

Drug Administration, 2009). These technological advances have resulted in earlier diagnoses of

breast lesions before they can be detected through clinical examination and the subsequent need

for more women to require pre-surgical localization of these non-palpable breast lesions.

Traditionally radiologists marked a non-palpable breast lesion through insertion of a thin

guide wire through the breast parenchyma into the breast lesion the morning of surgery and

removed the wire with the lesion during the partial mastectomy (Hughes et al., 2008). With wire

localizations, the surgeon must first speculate, then estimate, the amount of tissue to be removed

in relation to the wire and lesion on the post wire implantation mammogram. If cancer is noted

at or near the margin by the pathologist’s assessment of the specimen, the patient will require

additional surgery to confirm no cancer was retained in the breast. This procedure is known as a


“re-excision of the margin” (Smith & Host, 2007). A margin is the area of normal tissue that

surrounds the malignant mass. Although controversial, the most commonly accepted cancer-free

margin for a partial mastectomy is 2mm (Horst, Smitt, Goffinet, & Carlson, 2005; Jacobs, 2008).

The margin evaluation is a major factor linked with risk of breast cancer recurrence (Ceilley,

Goldberg, Jagsi, Mohiuddin, & Taghian, 2005; Pleijhuis et al., 2009). Re-excision rates

associated with wire localization range from 20% to 70% nationally (Smith & Host, 2007). Re-

excision is indicated if the margin is inadequate or if cancer cells are present or close to normal

breast tissue (Smith & Host, 2007). Experiencing additional surgery is emotionally, physically,

and financially draining to the patient and the medical system. As a result of this burden, several

new pre-surgical techniques have been developed to reduce the unacceptable rate of partial

mastectomy re-excisions due to inadequate margins.

One new technique used at the Mayo Clinics and at Parkland Health and Hospital

System’s Surgical Oncology Program is to place a small radioactive titanium seed into the breast

lesion rather than the traditional wire. In small studies the seeds have shown a 65% reduction in

positive margins allowing for fewer re-excision surgeries (Hughes et al., 2008). The seed can

also be placed 1 to 4 days prior to surgery for increased patient and staff convenience (Hughes et

al.). In addition, two recent studies found no increase in breast pain during the implantation of

the radioactive titanium seed when compared to the pain associated with the implantation of a

traditional wire (Hughes et al.; Gray, Pockaj, Karstaedt, & Roarke, 2004). These findings need to

be explored further to determine risks and benefits of new procedures to treat breast cancer and

factors associated with pain perception associated with breast cancer surgery. Resulting

knowledge will enhance health care providers’ ability to provide anticipatory guidance


concerning pain perception associated with pre-surgical localization procedures for non-palpable

breast lesions.

Population and Setting

The target population for this study was women 18 years of age and older who were

diagnosed with a non-palpable breast lesion undergoing a pre-surgical breast localization (RSL

or wire localization.) This prospective study was conducted at a large university hospital

associated with a medical college, which is an academic center for research.

Expected Outcomes

Although limited, the data on pain perception in respect to RSL and wire localization has

shown no difference in reported pain perception. It is expected that RSL will produce no increase

in pain perception when compared to wire localization. It could be possible that aggregate pain

perception as measured by pain visual analog scales could be less with RSL. There is no

literature correlating breast size in relation to pain experienced during pre-surgical localization

procedures. Physiologically, when using a standard dose of lidocaine hydrochloride, women

with larger breasts could be less anesthetized than women with smaller breasts then increasing

the pain perceived.

Definition of Terms

Margin. A margin is the amount of normal breast tissue surrounding a cancer once

removed from its origin. If cancer cells are close (less than 2 mm) or at the edge of the

specimen, the margin is stated to be inadequate (Horst, Smitt, Goffinet, & Carlson, 2005).

Partial Mastectomy. A partial mastectomy is a method of breast surgery utilized to

remove a breast mass. It is the process of removing only the breast mass with a small rim of

normal breast tissue around the targeted mass (Cancer, 2009).


Wire Localization. Prior to a partial mastectomy, a non-palpable breast lesion must be

localized for the surgeon to remove the targeted lesion. One technique to localize the lesion is to

insert a thin wire through the breast parenchyma into the lesion with the aid of sonography or

mammography prior to surgery. This process is completed by a radiologist (Gray et al., 2004).

The wire and lesion are removed together during the partial mastectomy

Radioactive Seed Localization. Prior to a partial mastectomy, a non-palpable breast

lesion must be localized for the surgeon to remove the targeted lesion. One technique to localize

the lesion is to insert a radioactive titanium seed through the breast parenchyma into the lesion

with aid of sonography or mammography prior to surgery. This process is completed by a

radiologist. The radioactive titanium seed is removed with the lesion during the partial

mastectomy (Gray et al., 2001).

Pain. The signal sent by nociceptors to the brain for interpretation initiated from damage

to nerve cells at the anatomical site of injury (Waddell, 2004). These signals are interpreted by

the brain as pain (International Association for the Study of Pain, 2009).

Brassiere Size. For this study, the stated cup size of the brassiere served as an empirical

indicator for breast size. The cup size is determined by the difference in the measurement of the

rib cage immediately below the breast and the largest measurement around the breast. The

following coding was used for analyses of brassiere size: 1 = A cup or smaller, 2 = B cup, 3 = C

cup, 4 = D cup, 5 = larger than a D cup.

Purpose

The purpose of the capstone project was to measure and compare overall pain perception

associated with the implantation of a radioactive titanium seed and the implantation of a wire for

the pre-surgical localization of non-palpable breast lesion. The second purpose of the capstone


project was to investigate the relationship between breast size and perceived pain associated with

the pre-surgical localization of a non-palpable breast lesion.

Research Question

The following research questions were addressed:

1. In women receiving pre-surgical localization of a non-palpable breast lesion, will

a radioactive titanium seed or a thin wire create less perceived pain?

2. Is there any relationship to perceived pain and breast size with two breast

localization techniques, radioactive titanium seed or wire?

Null Hypothesis

This capstone project addressed two null hypotheses.

1. There will be no significant difference in pain perception with pre-surgical radioactive

titanium seed localization and wire localization of non-palpable breast lesions.

2. There will be no significant correlation in perceived breast pain and breast size with two

pre-surgical localization techniques for non-palpable breast lesion: titanium seed

localization and wire localization.

Theoretical Framework

The theoretical framework that formed the foundation of this project was physiologic

pain theory, including the theoretical and physiological basis of how lidocaine hydrochloride

controls local pain. Pain has been described as a “multidimensional phenomenon that is

subjective in nature with physiological and psychological components” (Zalon, 1999, p. 135).

The International Association for the Study of Pain (IASP) defines pain as “an unpleasant

sensory and emotional experience associated with actual or potential tissue damage, or described

in terms of such damage” (International Association for the Study of Pain, 2009, definition


section, para. 19). Using anesthesia prior to surgical procedures is characterized as “an

antinociceptive treatment that prevents establishment of altered central processing of afferent

input from injuries” (Shen et al., 2008, p. 417).

Pain

Pain is sensed by receptor nerve cells in and under the skin (Waddell, 2004).

Nociceptors, pain receptor neurons centrally located in the spine, send fine thread like

projections to the entire body (International Association for the Study of Pain, 2009). The

receptor cells send messages along nerves into the spinal cord and to the brain, which interprets

the signals as pain (Waddell, 2004). Local anesthesia blocks this pathway or reduces the

efficiency of the signal to the brain.

The upper intercostal nerves and the supraclavicular nerves are the main supply of

innervations to the breast (Sarhadi, Dunn, Lee, & Soutar, 1996). The nerve supply for the nipple

and areola complex is supplied by anterior cutanious nerves of the intercostal nerves (Sarhadi et

al.). When surgery or invasive procedures are performed on the breast, the transection or

puncture of tissue damages the nerve endings of the breast (Sarhadi et al.). The injured nerves

are sensed by receptors and send messages along the nerves to the brain (Waddell, 2004). The

brain interprets these messages as pain.

Lidocaine Hydrochloride

The drug of choice for local control of pain in breast localization procedures is lidocaine

hydrochloride (Zagouri et al., 2007; Stojadinovic et al., 2009). The mechanism of action of

lidocaine hydrochloride is to “stabilize the neuronal membrane by inhibiting the ionic fluxes

required for the initiation and conduction of impulses, thereby affecting local anesthetic action”

(McCaffery & Pasero, 1999, p. 27). Physiological onset of lidocaine hydrochloride is within 2


minutes and the half life is 0.5 to 2 hours (McCaffery & Pasero). The peak anesthetic effects

occur between 2 and 5 minutes after subcutaneous infiltration, with anesthetic duration of 30

minutes to 1 hour (McCaffery & Pasero). The use of lidocaine hydrochloride for local anesthesia

in these procedures has been well established. Currently at Parkland Hospital, a standard dose of

2.5 ml of l% lidocaine hydrochloride, without epinephrine, is administered for all wire and

radioactive titanium seed localizations (S. Aymond, personal communication, September 5,

2009). The amount of lidocaine hydrochloride needed for sufficient local anesthesia

effectiveness is 2 ml per dermatome (Lidocaine hydrochloride, 2010). A dermatome is defined

as “the area of skin supplied with afferent nerve fibers by a single posterior spinal root”

(Dermatome, 2010, para. 1). This project assessed the possible need for increased or decreased

use of lidocaine hydrochloride for certain procedures that occur in a well-defined subset of

patients. This project was designed to determine if one pre-surgical procedure created an

increased perception of pain or if breast size would impact the need for increased or decreased

local anesthesia.

Review of Literature

The literature review was conducted through access of Pubmed and Cinahl data bases via

the Texas Woman’s University Library. The data search consisted of eight specific terms: (a)

breast cancer, (b) partial mastectomies, (c) wire localization of breast lesions, (d) seed

localization of breast lesions, (e) breast pain, (f) lidocaine hydrochloride, (g) visual analog scale

and (f) radioisotope occult lesion localization. The mesh function was utilized with Pubmed to

further refine the search. The articles were limited to English and the time period accessed

ranged from 1965 to 2010. Due to the historical data of breast surgery and wire localization


procedures, articles dating back to 1965 were accepted for the purposes of this literature review

and enhanced understanding about historical advances in breast cancer treatments.

Diagnostic Technologies

Mammography and sonography technologies are currently diagnosing over 85% of breast

cancers prior to tumor progression to a size large enough for the lesion to be clinically palpable

(Kerlikowske & Barclay, 1997; United States Food and Drug Administration, 2009).

Technological advances have spurred development of new procedures that assist the surgeon to

locate the non-palpable breast lesion. New localization procedures include uses of radioisotopes

or radioactive titanium seeds. Traditionally, surgeons used wire localization to identify the non-

palpable breast lesions prior to surgical removal (Rampaul et al., 2004).

Wire Localization

The traditional method to mark a non-palpable breast lesion is to advance a thin guide

wire into the breast through the breast parenchyma, in or near the lesion, by a radiologist the

morning of surgery. The first breast wire localization was documented in 1965 by Dodd and

associates (Dodd, Fry, & Delany, 1965). The wire localization process, with the aid of enhanced

mammography, has been greatly improved since Dodd pioneered the procedure. A local

anesthetic is administered prior to advancing the wire into the breast to aid in limiting or

eliminating the pain of the procedure. The standard drug of choice for this procedure is lidocaine

hydrochloride (S. Aymond, personal communication, January 10, 2010). After successful

localization of a non-palpable breast lesion with the thin wire, a post localization mammogram is

commonly taken to document the relationship of the wire to the lesion. The guide wire and

lesion are removed during the partial mastectomy by the surgeon (Hughes et al., 2008). The

surgeon must speculate about the amount of breast tissue that needs to be removed in relation to


the wire and lesion on the post-wire implantation mammogram. If cancer is noted at or near the

margin by the pathologist, the woman will require an additional operation to confirm no cancer

was retained in the surgical cavity. This procedure is known as a re-excision of margins (Smith

& Host, 2007). The re-excision rate for wire localized partial mastectomies ranges from 20% to

70% (Smith & Host). Even with the documented unacceptable re-excision rates, for decades the

wire localization procedure has remained the standard procedure for localizing non-palpable

breast lesions prior to partial mastectomies. In the past ten years there have been several new

attempts to improve the pre-surgical breast localization process.

Pain Perception

There are several articles that examine pain perception associated with pre-surgical wire

localization of a non-palpable breast lesion (Helvie, Ikeda, & Adler, 1991; Kelly & Winslow,

1996; Rampaul et al., 2004; Moreno, Wiltgen, Bodanese, Schmitt, Gutfilen, & Fonseca, 2008).

Helvie and associates (1991) reviewed 203 complications secondary to localization of non-

palpable breast lesions. The report stated only two of the wire localization complications were

associated with significant pain. The authors do not give details regarding the methodology used

to evaluate the patient’s pain but did state that lidocaine hydrochloride 1% was administered for

pain control. There amount of lidocaine hydrochloride used for the procedures was not

documented in these publications. The majority of the complications were due to a vasovagal

response, and the researchers proposed that the use of lidocaine hydrochloride did not attribute to

reported complications.

Kelly and Winslow (1996) researched wire localizations of non-palpable breast lesions to

evaluate what sensations women experienced during a wire localization procedure of a non-

palpable breast lesion. The researchers used a non-probability sample of 56 women with an


average age of 57 years. The patients were asked to rate pressure, stinging, and pain on an 11-

point numeric rating scale. Following the wire localization procedure, all study participants were

interviewed with a standardized questionnaire. The results indicated an average pain score of 7

on the 11 point Likert scale (0-10). Lidocaine hydrochloride was the anesthetic used during the

wire-localization procedure, but the amount and time of administration were not specified in the

study. The results of the research provided support that education of patients by nursing staff

decreases the amount of anxiety and pain the patient may experience with pre-localization

procedures. Probability scores were not provided.

Rampaul and associates (2004) conducted a clinical trial comparing traditional wire

localization to radioisotope occult lesion localization procedure (ROLL). The randomized trial

was conducted to compare radiological accuracy, surgical margins, ease of surgery, and pain

between the ROLL procedure and the wire localization procedure for non-palpable breast lesion

localization. A total of 95 women were randomized to either the ROLL procedure or a wire

localization procedure. The number of women randomized to the ROLL procedure was 48, and

47 women were assigned to the wire localization procedure. Pain was assessed on a 1-10 Likert

scale. Analysis of pain perception indicated that there was a decrease in pain associated with the

ROLL procedure in comparison to the wire localization procedure (2.7 verses 3.6, p = 0.012).

The final results of the study concluded that the ROLL procedure and wire localization

procedure were comparable regarding breast biopsies but the ROLL procedure was vaguely

superior to the wire localization procedure in regards to accuracy of localizing the lesion,

clearing surgical margins, ease of surgery, and decreased pain perception. . The authors did not

document the amount or type of local anesthesia used for these procedures. The use of differing


amounts or types of anesthesia could confound interpretation of the results regarding pain

perception.

In 2008, Moreno and associates repeated the research of Rampaul (2004), comparing the

ROLL procedure to the traditional wire localization procedure. The study randomized 120

participants with a mean age of 51.3 years into two groups, 59 patients into the wire localization

group and 61 patients into the ROLL group. No range was give for age. Using a 0 to10 Likert

pain scale, with zero meaning no pain and ten relating to the worst pain ever experienced, the

women were asked to rate the pain associated with the ROLL procedure and the wire localization

procedure on the first postoperative day. Analyses of pain perception indicated the ROLL

procedure created less pain. The mean pain score of the ROLL procedure and wire localization

procedure was 1.62 and 2.2 respectively. Probability results for pain scores were not stated. The

researchers did not document the amount of local anesthesia used during the wire localization.

The authors did monitor the amount of lidocaine with epinephrine administered during the

ROLL procedure and calculated a mean of 16 ml per patient. The range of lidocaine dosage used

was not provided. The data was calculated the day after the procedure. Delayed timing in

assessment of pain perception could skew results regarding perceived pain prior to surgery.

Seed Localization

The RSL procedure for non-palpable breast lesions was introduced at the Moffitt Cancer

Center in 1999 (Dauway, Sanders, & Freidland, 1999). The pilot study consisted of 25 patients.

All 25 patients had a non-palpable breast lesion removed with the aid of a radioactive titanium

seed implanted into the lesion prior to surgery. The radioactive seed was placed in an 18 gauge

needle, which was occluded with sterile bone wax on the distal end. A stilette was placed in the

proximal end of the needle to prevent unwanted expulsion of the seed during the placement.


After local anesthetic was infused into the skin and breast parenchyma, the needle was then

inserted into the breast and forwarded towards the location of the targeted breast lesion. The

needle was guided through the breast parenchyma with the aid of sonography or mammography,

which is the same technology utilized for wire localizations of non-palpable breast lesions. A

stilette was used to advance the seed through the bone wax, out of the needle, and into the breast

at the location of the lesion. The needle and stiletto were then removed from the breast with the

seed in situ. There was no pain measurement during this pilot study or documented type or

amount of anesthesia used. The pilot study did demonstrate the safety and efficiency of the

radioactive titanium seed localization procedure.

In 2001, the results of the first prospective randomized trial comparing wire localization

to RSL were published by Grey and associates. The trial randomized 97 women with non-

palpable breast lesions to pre-surgical wire localization or RSL. The participants who were

randomized to the RSL had 21% (26% to 57%, p = .02) fewer re-excisions than the participants

who received the wire localization. Study participants were asked to grade the ease of the

procedure, but specific pain documentation was not obtained. There was no description of the

amount or type of anesthesia used in these procedures. The mean ease of procedure score of the

RSL was 2.59 and wire localization procedure was 2.61 (p = 0.97). There was no statistical

difference between the two randomized groups.

Seed localization research continued at the Mayo Clinics. In 2003, Cox and associates

(2003) published the next study comparing RSL to wire localization. The researchers performed

100 wire localization procedures at the Mayo Clinic in Arizona followed by 134 seed

localizations dispersed from multiple Mayo Clinics. The research did not elicit any pain data

from the patients and focused on (a) decreasing the need for post-surgical specimen radiographs,


(b) reduction in operating time, (c) superior localization of the non-palpable lesion, and (d) fewer

resections to clear margins. The results indicated a decrease in the need for specimen

radiographs, 79% in 124 patients (p < .02). The RSL allowed for fewer specimen radiographs,

which reduced operating room time, decreased the time a patient is under anesthesia, and

lowered re-excision rates.

In March of 2004, Gray and associates presented an update of the RSL program at the

Mayo Clinics for localizing non-palpable breast lesions at the Fifth Annual Meeting of the

American Society of Breast Surgeons. The authors conducted a nonrandomized prospective

study comparing wire localization to RSL for non-palpable breast lesions. The first 100

participants underwent wire localizations at the Mayo Clinic in Arizona. The next 100 women

with non-palpable breast lesions were localized with a RSL prior to surgery. Analysis of results

indicated a 35% reduction in positive margins with the RSL in comparison to wire localization (p

= 0.01). The re-excision rate was reduced by 62% (p = 0.01). A visual analog scale, 0 to 10,

was utilized to measure the pain associated with radioactive seeds and wires. Although the

researchers only evaluated the last 32 patients receiving wire localization for pain perception,

they evaluated all 100 of the RSL patients. There was no explanation for the exemption of the

first 68 wire localization patients. The mean pain score of both RSL group and the wire group

was 2.0 (p = 0.43). There was no documentation of the type or amount of anesthesia

administered for the localization procedures. Due to the lack of data from the first 68 wire

localization patients, the mean scores obtained from the last 32 patient may not reflect the mean

of the entire sample of 100 patients. The research demonstrated that RSL was: (a) superior to the

wire localization in reducing close or positive margins, (b) safer, and (c) more efficient for the


surgeons and radiologists. There was no conclusive data on participant pain perception related to

the two procedures.

In 2008, the Mayo Clinics continued to study RSL in comparison to wire localization for

non-palpable breast lesions using multiple sites for the study. . Hughes and associates (2008)

conducted a prospective, nonrandomized study recruiting eligible participants in a sequential

manner at three Mayo Clinic locations. Although the first 100 patients underwent wire

localizations at the Mayo Clinic in Arizona, the 303 RSL patients were recruited from all three

Mayo Clinics. The majority (262 RSL procedures) was completed at the Arizona Clinic; 64 at

the Mayo Clinic in Rochester; and 57 procedures were performed at the Mayo Clinic of

Jacksonville. Mocking the pain assessment tool utilized in the 2004 research, a visual analog

scale (0-10) was used to measure perceived pain of the two localization procedures. As in 2004,

only the last 32 participants of the 100 who underwent wire localizations completed the visual

analog pain scale and 371 of the 383 RSL patients completed the pain scale. No explanation was

given for exclusion of the first 68 wire localization patients. The wire localization mean pain

score was 2.3 compared to the RSL mean pain score of 2.2 (p = 0.9). There were no details for

the type or amount of local anesthesia administered for either localization procedures. The re-

excision rate for participants who were localized through RSL was 19% less than participants

experiencing wire localization procedures (p < 0.001). The RSL was again proven to be superior

to wire localization in relation to decreased re-excision rates. The quality of the pain research did

not increase the body of knowledge about pain perception in these two populations because of

these design flaws. .

In 2009, Jakub and associates at the Mayo clinic reviewed the data collect for the past 10

years, beginning with the initial pilot study of 1999. These four studies were analyzed


individually and collectively. There have been 565 RSL procedures performed by the Mayo

Clinics during these four studies, and 204 wire localizations were performed for comparison.

The re-excision rate for all studies ranged from 26% to 41% for the RSL procedure and 46% to

57% for the wire localization procedure. The pain scores for RSL procedures ranged from 2.0 to

2.2 and wire localizations ranged from 2.0 to 2.3 on an 11 point scale. The article described the

profound reduction in re-excision rates, safety of use, and reduction of operating and anesthesia

time with the RSL procedure. The authors explained the need for further research on RSL but

concluded that this new technique had much potential to improve care and accurately localize

non-palpable breast lesions.

In summary, four research articles and one summary article have been published

comparing RSL and wire localizations since the initial RSL pilot study in 1999. Each study

concluded that the RSL procedure is safe, effective, and could reduce re-excision rates in

comparison to wire localization procedure (Cox et al., 2003; Gray et al. 2001; Gray, Pockaj,

Karstaedt, & Roarke, 2004; Hughes et al., 2008; Jakub et al., 2009). Only two of the studies

gathered data specific to pain experienced by the participants in relation to the two localization

procedures (RSL and wire localization) (Jakub et al.). Of these two, a significant number (130 of

200 participants) of wire localization patients were omitted from assessing perceived pain via the

visual analog pain scale. No explanation was given. Due to the lack of data collected from the

first 65 wire localization procedures of both studies, the value of the research conducted on the

pain associated with these two pre-surgical procedures has been weakened. (Jakub et al.). The

probability scores of pain (p = 0.43, p = 0.9) were not consistent and not significant. There was

no documentation of the amount or type of anesthesia administered for the localization

procedures. With the addition of multiple sites comparing to previous findings from one site, the


documentation of the type, amount, and technique utilized for local anesthesia would have added

significant strength to the findings of pain perception. To date, there have been no documented

reports of a correlation of breast pain and breast size during a wire localization procedure or a

radioactive titanium seed localization procedure.

Project Implementation and Results

Objectives and Planned Evaluation of Objectives

The vision statement of Parkland Hospital states: “By our actions, we will define the

standards of excellence for public academic health systems” (Parkland, 2010, para. 3). Parkland

Hospital treats over 250 new cases of breast cancer each year and hundreds of benign breast

lesions (Parkland, 2010). Localizing non-palpable lesions prior to breast surgery is a common

procedure at Parkland’s Breast Imaging Center (S. Aymond, personal communication,

September 5, 2009).

The first objective of this project was to increase the knowledge and understanding of

breast pain associated with pre-surgical localization of non-palpable breast lesions with relation

to traditional wire localization and radioactive titanium seed localization utilizing a visual analog

scale. To date, only two studies, with small populations of patients, have directly compared pain

experienced during RSL procedures and wire localization procedures. Evaluation of obtained

data was calculated using Mann Whitney U statistical analysis.

The second objective of this project was to explore any association of breast size to

participant’s pain perception of pre-surgical localization of non-palpable breast lesions using

either RSL or wire localization. This data was captured on a one page questionnaire gathering

the patient’s brassiere sizes and perceived pain after a pre-surgical breast localization procedure.

Evaluation of data obtained for the second objective was calculated using Kendall’s tau-b. There


are no reports in the literature correlating breast pain with breast size in relation to RSL and wire

localization procedures. With additional knowledge relating to pain associated with pre-surgical

localization techniques, better control techniques can be established for specific patients and

procedures. The ultimate goal of this project is to provide better care to the patient’s diagnosed

with breast cancer by increasing understanding of pain associated with pre-surgical localization

of non-palpable breast lesions.

Time Line

The timeline consisted of the initial application to the Institutional Review Board (IRB)

of the University of Texas Medical Center at Dallas (see Appendix A). The IRB application was

submitted to the University of Texas Medical Center at Dallas on September 12, 2009. On

September 24, 2009, the University of Texas Medical Center at Dallas IRB granted approval for

this project (see Appendix B). The IRB number provided by the University of Texas IRB is

092009-058. Successful defense of the Capstone project was completed at Texas Woman’s

University October 5, 2009. The IRB application to Texas Woman’s University was submitted

on October 6, 2009 (see Appendix C). IRB approval was granted by Texas Woman’s University

on October 20, 2009 (see Appendix D). The data collection was initiated on October 30, 2009

and concluded February 24, 2010. Statistical analysis was initiated on February 24, 2010 and

concluded on March 1, 2010. The final paper was completed March 22, 2010. Refer to

Appendix E for the complete time line.

Setting

The site of this project was Parkland Hospital, which is part of an academic health care

setting associated with University of Texas Southwestern Medical College. The Breast Center at


Parkland Hospital performs all pre-surgical breast localizations, over 150 per year (S. Aymond,

personal communication, September 5, 2009).

Project Requirements

Overall support was needed from Parkland Health and Hospital System’s Breast Center

and surgical oncology team. The personnel who contributed to this study included three master’s

prepared nurse practitioners who were currently employed by Parkland Health and Hospital

System. These nurse practitioners participated in data collection at no cost to the project. All

materials needed for the project were supplied by the principal investigator. A one page

questionnaire, provided in English and Spanish, was used to collect data (see Appendices F and

G). The one page questionnaire was translated from English to Spanish by a certified Spanish

translator of Parkland Health and Hospital System. The Spanish questionnaire was translated

back to English by a second certified translator at Parkland Health and Hospital System. There

was no inconsistency in the translation from English to Spanish or Spanish to English. Both

translators have been certified by the Michigan Certification Exam for Spanish.

Sample

A convenience sample was obtained consisting of women who were diagnosed with non-

palpable breast lesions and scheduled for pre-operative localization of this lesion. The surgical

oncology operating schedule was accessed to identify patients who met inclusion criteria. The

number of participants was determined by the types of procedures that were scheduled during the

research time period. Nevertheless, this convenience sample was fairly evenly distributed

between women who were scheduled for RSL and women who were scheduled for wire

localization procedures. Planned statistical analyses involved selection of nonparametric tests

appropriate for small samples.


Inclusion and Exclusion Criteria. After the patients were identified, the principal

investigator reviewed the patient’s chart for eligibility. The inclusion criteria consisted of any

female patient of 18 years of age or older who was scheduled for pre-surgical localization of a

non-palpable breast lesion at Parkland Hospital between October 29, 2009 and February 24,

2010. The exclusion criteria consisted of patients with chronic pain, unable to read English or

Spanish or patients with altered mental status. There were no exclusions based on race, ethnic

background, life expectancy, nutritional status or performance status.

Informed Consent Process. During the preoperative appointment, 1 week prior to surgery,

all qualified and eligible patients were invited to participate in the study by the principle

investigator. The study process was explained to the patients in detail by the principle

investigator. Once the patient elected to participate in the study, a written informed consent was

obtained (see Appendix H). No patient refused to sign the consent. The consent was collected

and stored by the principle investigator in a locked, secure file cabinet.

Methodology

Two radiologists performed all pre-operative localization procedures for all research

participants. Both radiologists were board certified radiologist with a specialty in

mammographic radiology and certified in all procedures that are indicated. Both physicians used

the same protocols and technique for wire localization and RSL. All pre-surgical localization

patients, RSL and wire localization, were given identical local anesthesia, 1% lidocaine

hydrochloride without epinephrine. A standard of 2.5 ml of 1% lidocaine hydrochloride without

epinephrine was injected into the breast to be localized with a one and a half inch 25 gauge

syringe (S. Aymond, personal communication, September 5, 2009). All radioactive seeds and

wires were introduced into the breast with an 18 gauge trocar.


The morning of surgery, after the localization procedure had been completed, prior to

surgery, the patient was given the one page questionnaire to answer. Once collected, the data

was transferred into an Excel® data base for statistical analysis with no identifiable human

subject information linked to the final database. The original consent form with the patient’s

questionnaire was stored by the principle investigator. The information provided by the patient

was moved into a database, with access restricted to the primary investigator only. Final

analyses of data were conducted with statistician consultation using SPSS® to assess the pain

associated with two pre-surgical procedures and possible correlation of pain to breast size.

Instrument: Visual Analog Scale.

The tool that was utilized to assess pain associated with the patient’s localization

procedure was an 11 point visual analog pain scale (see Appendix I). Visual analog scales have

been used in many research studies, with consistent reports of content, construct validity and

reliability (Breivik, Bjornsson, Skovlund, 2000; Dalton & McNaull, 1998; Jones et al., 2008;

Williamson & Hoggart, 2005). Research by Jones and associates (2008) calculated a Cronbach’s

alpha of 0.88 on a 0 to 10 visual analog scale utilized to measure pain with patients diagnosed

with fibromyalgia.

The pain scale for this study was an 11 point numeric scale from 0 to 10. Zero was

defined as no pain; five was defined as distressing pain; and ten was defined as unbearable pain.

The tool was available in English and Spanish. Permission was granted for use of the 0-10 visual

analog scale for this project (M. McCaffery, personal communication, September 18, 2009).

Other information collected on the one page questionnaire included (a) age, (b) race, (c) number

of prior breast biopsies, (d) brassiere size, (e) prior history of wire localization and/or seed

localization, and (f) use of chronic pain medication.


Evaluation of Objectives

On a weekly basis the surgical oncology schedule was obtained from the care coordinator

and reviewed for potential participants in the research project. A list of patients scheduled for

pre-operative breast localization was collected by the principle investigator. A note was placed

into the electronic record of each eligible patient requesting a staff member to page the principle

investigator upon the patient’s arrival to the oncology clinic for the pre-operative appointment.

The day of the pre-operative appointment, once the patient was in a treatment room, the

patient was approached by the principle investigator for participation in the study. If

participation was desired, an informed consent was signed by the patient and retained by the

investigator. The informed consent was stored in an office with access to only the principle

investigator. If participation was declined, the patient was shown gratitude for considering the

study and no further action was taken.

The day of the localization procedure, the investigator would meet the consented patient

after the localization procedure but prior to surgery for the completion of the questionnaire. This

conference would take place in a pre-operative room in the day surgery unit. Once the

questionnaire was completed, the patient was shown appreciation for participation in the study.

The questionnaire was matched with the consent and stored in a private office at Parkland Health

and Hospital by the primary investigator.

At the completion of data collection, all data was placed into an Excel® spreadsheet and

exported to SPSS®. The data was then sent to a statistician for final analysis. Demographic

variables were analyzed using descriptive statistics appropriate to the level of measure of the

variable. The first objective was to compare pain perceived during RSL procedures and wire

localization procedures. Evaluation of this obtained data was calculated using Mann Whitney U


statistical analysis. The second objective, assessing the relationship between breast size and pain

perception during a pre-surgical breast localization procedure was evaluated using Kendall’s tau-

b.

Once the analysis was completed the results were obtained by the principle investigator

for review. The signed consents and completed questionnaires are stored by the primary

investigator for duration of five years in a secure, locked file cabinet. At the end of this period,

paper documents will be shredded and aggregate digital files destroyed.

Expected Results/End Products

Parkland Health and Hospital System is a large county hospital with limited resources.

Due to the overwhelming health needs of the residents of Dallas County, the system often

functions at capacity. Parkland Health and Hospital System medical and administrative

leadership are constantly striving to improve patient care while controlling healthcare cost.

Seldom does innovative technology both improve patient care and control or decrease the cost.

The breast center of Parkland Health and Hospital performs hundreds of breast

localization procedures yearly for pre-surgical localization of non-palpable breast lesions (S.

Aymond, personal communication, January 21, 2010). There has been a trend to utilize the RSL

procedure over the wire localization procedure due to the reduction in operative time, anesthesia

time, and most importantly, reduction in re-excisions (S. Aymond, personal communication,

January 21, 2010). The RSL procedure has shown to decrease the re-excision rate of patients

with non-palpable breast lesions by as much as 68% (Gray et al., 2004). This decrease in re-

excision rates has a dramatic effect on the next available operative day for the surgical oncology

team, while driving down the overall cost of treating patients for the hospital.


Parkland Health and Hospital System has a vision to be at the forefront of innovative

medical care and a leader in public health (Parkland, 2010). A new technological innovation,

such as the RSL procedure, has great potential to fulfill the mission. Increasing the knowledge

of pain associated with the RSL procedure in comparison to the wire localization procedure will

improve the ability to provide anesthetic control and provide anticipatory guidance for the

patient. Particularly with innovative procedures such as the RSL, it is essential to not create

undue pain or harm to the patient. This research provided evidence to understand the pain

involved with two pre-surgical localization techniques. The end result will facilitate processes to

decrease the perceived pain associated with breast localization procedures and compare two

localization procedures in relation to pain. Although there was no direct benefit to patients

included in this study, future patients will gain from an enhanced understanding of the pain

experienced with the breast localization process.

After statistical analysis of the data has been completed, the outcomes will be presented

to Texas Woman’s University Doctor of Nursing Practice staff and the surgical oncology and

radiology teams of Parkland Health and Hospital System. This information will initiate

improved confidence in the RSL procedure and increase the knowledge of anesthetic control for

perceived pain in the localization process of non-palpable breast lesion prior to surgery.

Project Evaluation and Recommendations

Plan for Data Evaluation

Statistical analysis for data collected included application of Mann Whitney U test,

Fisher’s Exact Test, and Kendall’s tau-b test. Data was recorded in an Excel® file and

downloaded into SPSS® for analyses. Statistical consultation was obtained from a

biostatistician with doctoral preparation. Results and conclusions from these analyses will guide


future research and contribute to knowledge about possible changes needed to decrease pain

perception in women who will experience the pre-surgical localization process.

For comparing the two mean scores of pain in relation to RSL and wire localization, the

Mann Whitney U test was performed via SPSS®. The Mann Whitney U test is the appropriate

statistic for nonparametric significance testing between two independent samples (Pallant, 2007).

Data analysis indicated there was no statistical difference in pain perception in relation to RSL

and wire localization procedures in this sample. These results will guide future protocols and

procedure techniques to possibly decrease the amount of pain perceived during a pre-surgical

breast localization procedure. The mean pain scores will provide insight in relation to the

potential benefits of the RSL program at Parkland Health and Hospital System.

To evaluate the possible correlation of breast pain to breast size during a pre-surgical

breasts localization procedure, a Kendall’s tau-b test was performed on the data with the aid of

SPSS®. Kendall’s tau-b test is a statistical evaluation of a correlation between two ordinal level,

nonparametric, measurements (Pallant, 2007). No statistically significant correlation between

breast size and pain was noted. This information provided evidence that equal amounts of

anesthesia are appropriate for all patients, irrelevant to breast sizes, during a pre-surgical breast

localization procedure.

Statistical Analyses

There were 25 participants in this study with 11 patients in the seed localization type

group and 14 patients in the wire localization type group. The percentage of Hispanic women

was 72.7% (8/11) in the seed group and 50% (7/14) in the wire group. Self-identified race for

the 7 other patients in wire group was 5 (35.7%) Blacks, 1 (7.1%) Asian, and 1 (7.1%) Other.


The 3 other patients in the seed group were 1 (9.1%) Black, 1 (9.1%) White, and 1 (9.1%) Other.

The percentage of Hispanic women that utilized the Spanish questionnaire was 53.3% (8/15).

The average age in the seed group was 56.6 (SD = 13.79, Mdn = 53, Range: 40-82) and

47.6 in the wire group (SD = 14.89, Mdn = 43, Range: 22-77). Age was not statistically

significant between these two groups (t (25) = 1.53, p = 0.139).

The number of breast biopsies was similar between the 2 groups; 72.7% (8/11) had 1

biopsy in the seed group and 78.6% (11/14) in the wire group. Brassiere size was similar

between the 2 groups. The median size in both groups was a 3 (C cup) with 45.5% (5/11) of the

patients in the seed group and 57.1% (8/14) of the patients in the wire group with a size of 3 (C

cup). The Mann-Whitney U test for breast size differences between these two groups was non-

significant (p = 0.551)

The percentage of patients with a previous wire procedure was similar in both groups,

18.2% (2/11) in the seed group and 7.1% (1/14) in the wire group (Fisher’s exact test p = 0.565).

None of the patients had undergone a prior seed localization procedure.

Only one (9.1%) patient in the seed group reported taking pain medication daily. The

Fisher’s exact test was non-significant (p = 0.440). The average rating of pre-surgical pain was

2.27 (SD = 1.68, Mdn = 2, Range: 0-5) in the seed group and 3.86 (SD = 2.93, Mdn = 4, Range:

0-9) in the wire group; the Mann-Whitney U test comparing these groups was non-significant (p

= 0.158).

The correlation between pain pre-surgical and brassiere size was non-significant

(Kendall’s tau-b, p = 0.794). Due to the small sample size in the study, the brassiere variables

(cup size) were collapsed into three categories for further analysis of correlation between pre-


surgical pain and brassiere size. The correlation results combining close categories between pain

pre-surgical and brassiere size was non-significant (Kendall’s tau-b, p = 0.874).

Discussion

Although not statistically significant, the RSL procedure produced a lower mean pain

score than the wire localization procedure (2.7 versus 3.86, p = 0.158). There was no attrition;

all 25 participants who signed the consent completed the questionnaire. The mean pain scores of

this project were similar to the mean pain scores found in the literature when comparing RSL to

wire localization using a similar pain assessment tool (Gray, Pockaj, Karstaedt, & Roarke, 2004;

Hughes et al., 2008). Only one patient in the seed group reported daily pain medication

consumption, and this was a non-significant finding (p = 0.44). All 25 patients had previously

experienced at least one breast biopsy, creating a similar history of invasive breast procedures.

There were no participants who had experienced a RSL procedure, and only three patients had a

past experience of wire localization. Statistical analyses of these data from this sample

supported the null hypothesis; there was no statistical difference in perceived breast pain in the

two groups, RSL and wire localization.

Brassiere size was non-significant in both groups (RSL and wire localization) in relation

to the perceived pain experienced (p = 0.874). Due to limited subjects, the variable of brassiere

size was collapsed into three separate categories, small brassiere sized (A & B cup), medium

brassiere sized (C cup), and large brassiere sized (D or larger cup). The results of the collapsed

categories concluded a non-significant relationship between breast size and perceived breast pain

during a pre-surgical localization procedure, RSL or wire localizations (p = 0.794). The null

hypothesis was supported; there was no statistical difference between breast size and pain


perception in RSL and wire localization. This is the first study to examine these two variables in

a population of women experiencing RSL or wire localization surgery.

Results from this study supported the proposition that RSL has great potential to be a

superior method to wire localization in localizing a non-palpable breast lesion creating no

increase in pain for the patient (Gray, 2004). This procedure, RSL, has consistently shown lower

re-excision rates, less operative time, and no increase in pain perception for the patient during

implantation in direct comparison to wire localization. Reductions in re-excision rates of the

RSL are reported to be as high as 64%. The cost reduction for treating women with non-palpable

breast lesions is significant (Gray, 2004). A reduction of re-excisions will also increase

availability of scarce operating room time. As in many large county hospitals, Parkland Hospital

has a greater need for operating time than can be accommodated in the present facility with

current case loads. The dwell time for a patient with breast cancer to receive a localized partial

mastectomy is four weeks as of the writing of this paper (T. Jones, Personal communication,

February 25, 2010). Reducing the need for a re-excision without creating an increase in patient

discomfort is an innovation that must be further explored.

Project Limitations

The breast surgeons at Parkland Health and Hospital System choose the type of breast

localization procedure (RSL or wire localization) based on the patient’s specific needs. With the

inability to randomize the subjects, a convenience sample was utilized for this project

diminishing the extrapolation of the data to the general population. Nevertheless, the risk of

sample bias was minimal secondary to the patient’s powerlessness to choose the type of breast

localization procedure.


The number of participants was a limiting factor. Of the 25 participants, only one patient

described her cup size as A or smaller and only one patient described her breast as larger than a

D cup. The small sample size reduces the external validity and generalizability of the study.

Previous research comparing RSL and wire localization lacks information about the relationship

of breast size to pain perception during the localization procedure.

Another limitation that could possible affect the pain involved with a pre-surgical

localization procedure is the location of the breast lesion. There was no documentation of the

depth, size, or location of the lesion in the breast or the approximation to the nipple, where many

nerve endings are located. A standard size needle (1.5 inch, 25 gauge) was used for all

procedures, with no consideration for the position of the lesion in the breast or breast size. The

location of the lesion may influence the ability to effectively achieve anesthesia.

Future Recommendations

Of the four published articles comparing RSL and wire localization, only two explored

pain perception. In these two studies, the sample sizes of patient’s pain perception receiving

wire localizations were greatly reduced in comparison with the sample sizes of patients receiving

RSL. An increase in sample size is needed to strengthen the current findings of breast pain

during a RSL in comparison to wire localization. Continued use of a bilingual questionnaire

would aid in increasing sample sizes.

This study found no relationship between breast size and perceived pain during a pre-

surgical localization procedure. Future research should include the specific location, depth, and

size of the lesion in the breast when evaluating the pain perceived during a pre-surgical

localization. Also needed are women with various breast sizes, small to large. The location of


the lesion may impact the amount of local anesthesia needed or the size of the needle to dispense

the anesthesia.

Conclusion

Wire localization has been the traditional method to localize non-palpable breast lesions

for decades, with well-documented limitations associated with this procedure (Smith & Host,

2007; Jakub et al., 2009). With any advances in medicine, new innovation must be compared to

the standard of care. This project compared pain of RSL to wire localization and found no

increase in pain perception to the patient. The literature consistently reports RSL as a superior

method to localize non-palpable breast lesions when compared to wire localization in relation to

re-excision rates, efficiency, operating time, overall cost to treat, and convenience (Gray, Jakub

et al., 2004; Hughes et al., 2008). This research has added to increasing data that RSL causes no

increase in pain to the patient. Additional evaluation must be documented before the medical

community accepts RSL as the standard, but the mounting evidence supporting the superiority of

this procedure is persuasive.


References

Breivik, E.K., Bjornsson, G.A., & Skovlund, E. (2000). A comparison of pain rating scales by

sampling from clinical trial data. Clinical Journal of Pain, 16(1), 22-28.

Cancer (2009). Texas cancer facts and figures. Retrieved February 3, 2010 from

http://www.acsf2f.com/Docs/TxCC_F&FBrch08.pdf

Ceilley, E., Goldberg, S., Jagsi, R., Mohiuddin, M. & Taghian, A. (2005). Current perceptions

regarding surgical margin status after breast-conserving therapy. Annals of Surgery, 241,

4, 629-639.

Cox, E.C., Furman, B., Nicholas, S., Ebert, M., Clark, J., Dupont, E., et al. (2003). Radioactive

seed localization breast biopsy and lumpectomy: Can specimen radiographs be

eliminated? Annals of Surgical Oncology, 10(9), 1039-1047.

Dalton, J. & McNaull, F. (1998). A call for standardizing the clinical rating of pain intensity

using a 0 to 10 rating scale. Cancer Nursing, 21 (1), 46-49.

Dauway, E.L., Sanders, R., Freidland, J. (1999). Innovative diagnosis for breast cancer: New

frontiers for the new millennium using radioactive seed localization. Presented at: 85th

Annual American College of Surgeons Clinical Congress; Chicago, IL.

Dermatome. (2010). In Merriam-Webster Online Dictionary. Retrieved February 21, 2010, from

http://www.merriam-webster.com/dictionary/dermatome

Dodd, G. D., Fry, K. & Delany, W. (1965). Management of the patient with cancer.

Philadelphia: Saunders.


Gray, R. J., Salud, C., Nguyen, K., Dauway, E., Friedland, J., Berman, C. et al. (2001).

Randomized prospective evaluation of a novel technique for biopsy or lumpectomy of

nonpalpable breast lesions: Radioactive seed verses wire localization. Annals of Surgical

Oncology, 8(9), 711-715.

Gray, R.J., Pockaj, B.A., Karstaedt, P.J., & Roarke, M.C. (2004) Radioactive seed localization of

nonpalpable breast lesions is better than wire localization. The American Journal of

Surgery, 188, 377-380.

Helvie, M.,A., Ikeda, D.M., & Adler, D.,D. (1991). Localization and needle aspiration of breast

lesions: complications in 370 cases. American Journal of Roentgenology, 157(4), 711-

714.

Horst, K.C., Smitt, M.C., Goffinet, D.R., Carlson, R.W. (2005). Predictors of local recurrence

after breast-conservation therapy. Clinical Breast Cancer, 5(6), 425-438.

Hughes, J.H., Mason, M.C., Gray, R.J., McLaughlin, S.A., Degnim, A.C., Fulmer, et al. (2008).

A multi-site validation trial of radioactive seed localization as an alternative to wire

localization. The Breast Journal, 14(2), 153-157.

International Association for the Study of Pain. (2009). IASP pain terminology. Retrieved

September 23, 2009 fromhttp://www.iasp-

pain.org/AM/Template.cfm?Section=Home&Template=/CM/HTMLDisplay.cfm&Conte

ntID=1728#Pain

Jakub, J.W., Gray, R.J., Degnim, A.C., Boughey, J.C., Gardner, M., Cox, C.E. (2009). Current

status of radioactive seed for localization of non palpable breast lesions. American

Journal of Surgery, 188(4), 377-380.


Jacobs, L. (2008). Positive margins: the challenge continues for breast surgeons. Annals of

Surgical Oncology, 15, 1271-1272.

Jones, K.D., Burckhardt, A., Deodhar, N., Perrin, A., Hanson, M. & Bennett, R. (2008). A six-

month randomized controlled trial of exercise and pyridostigmine in the treatment of

fibromyalgia. Arthritis Rheumatology, 58 (2), 612-622.

Kelly, P. & Winslow, E.H. (1996). Needle wire localization for nonpalpable breast lesions:

sensations, anxiety levels, and information needs. Oncology Nursing Forum, 23 (4), 639-

645.

Kerlikowske, K., & Barclay, J. (1997). Outcomes of modern screening mammography. Journal

of National Instituted of Cancer Monographs, 22, 105-111.

Lidocaine hydrochloride. (2010). Lidocaine hydrochloride. Retrieved February 21, 2010, from

http://www.drugs.com/ppa/lidocaine-hcl-epinephrine.html

McCaffery, M., & Pasero, C. (1999). Pain: Clinical manual. St. Louis: Mosby.

Moreno, M., Wiltgen, J.E., Bodanese, B., Schmitt, R.L., Gutfilen, B., & Fonseca, L.M. (2008).

Radioguided breast surgery for occult lesion localization – correlation between two

methods. Journal of Experimental and Clinical Cancer, 15(27), 29.

National Cancer Institute (2009). Breast Cancer. Retrieved February 23, 2009 From

http://www.cancer.gov/cancertopics/types/breast

Pallant, J.E. (2007). SPSS survivor manual. (3rd ed.). Crows Nest, Australia: Allen and Unwin.

Parkland Hospital, (2010). At a glance. Retrieved February 21, 2010, from

http://www.parklandhospital.com/index.html


Pleijhuis, R.G., Graafland, M., Vries, J., Bart, J., Jong, J.S., & VanDam, G.M. (2009). Obtaining

adequate surgical margins in breast-conserving therapy for patients with early-stage

breast cancer: Current modalities and future directions. Annuals of Surgical Oncology,

16(10), 2717-2730.

Rampaul,R.S., Bagnall, M., Burrell, H., Pinder, S. E., Evans, A.J., & Macmillan, R.D.(2004).

Randomized clinical trial comparing radioisotope occult lesion localization and wire-

guided excision for biopsy of occult breast lesions. British Journal of Surgery, 91 (12),

1575-1577.

Sarhadi, N.S., Dunn, D., Lee, F.D., & Soutar, D.S. (1996). An anatomical study of the nerve

supply of the breast, including the nipple and areola. British Journal of Plastic Surgery,

49(3), 156-164.

Shen, X., Wang, F., Xu, S., Ma, L., Lui, Y., Feng, S.,…Guan, X. (2008). Comparison of the

analgesic efficacy of preemptive and preventive tramadol after lumpectomy.

Pharmacology Reports, 60(3), 415-421.

Smith, M., Host, K. (2007). Association of clinical and pathologic variables with lumpectomy

surgical margin status after preoperative diagnosis or excisional biopsy of invasive breast

cancer. Annals of Surgical Oncology, 14, 4040-4044.

Stojadinovic, A., Peoples, G.E., Jurgens, J.S., Howard, R.S., Schuyler, B, Kwon, K.H., Henry, L.

R. (2009). Standard verses pH-adjusted and lidocaine supplemented radiocolloid for

patients undergoing sentinel-lymph-node mapping and biopsy for early breast cancer

(PASSION-P trial): a double-blind, randomized controlled trial. Lancet Oncology, 10 (9),

838.


United States Food and Drug Administration (2009). An effective defense against breast cancer:

FDA’s mammography quality standards program. Retrieved March 16, 2009 from

http://www.fda.gov/opacom/factsheets/justthefacts/20mammo.html

Waddell, G. (2004). The back pain revolution. United Kingdom: Elsevier.

Williamson, A., Hoggart, B. (2005). Pain: A review of three commonly used pain rating

scales. Journal of Clinical Nursing, 14(7), 798-804.

Zagouri, F., Sergentanis, T. N., Gounaris, A., Kouolocheri, D., Nonni, A., Domeyer, P., et al.

(2007). Pain in different methods of breast biopsy: emphasis on vacuum-assisted breast

biopsy. Breast, 71 (5), 71-75.

Zalon, M. (1999). Comparison of pain measures in surgical patients. Journal of Nursing

Measurement, 7, 135-152.


Appendix A

University Of Texas IRB Form


The University of Texas Southwestern Medical Center at Dallas Institutional Review Board1

IRB Form NR1 EXP: Application for Review of Expedited Research (Revised April 2005)

Title of Research2

An assessment of pain associated with two pre-surgical localization techniques for nonpalpable breast lesions, wire localization and radioactive titanium seed localization.

Sponsor and Grant Number3

William Lodrigues MS, WHCNP-BC

Assurances of the Principal Investigator and Sub-investigators

• To safeguard human subjects involved in this research, I agree to use procedures that conform to the policies of the University of Texas Southwestern Medical Center at Dallas and the regulations of the Department of Health and Human Services and the Food and Drug Administration.

• Unless it is necessary to eliminate apparent immediate hazard to a human subject, I shall seek prior approval from the Institutional Review Board (IRB) for substantive changes in the investigative procedures involving human subjects that may be called for during the research covered by this application.

• I shall agree to follow the advice of the IRB.

• I agree to report immediately to the IRB any unanticipated, life-threatening, or fatal complications with respect to human subjects.

• My signature certifies that I assure compliance with the ethical principles and institutional policies regarding the protection of human subjects in research as stated in Title 45 Code of Federal Regulations Part 46 (revised June 18, 1991; reprinted April 2, 1996) and the Federal Wide Assurance.4

1The IRB reviews all research involving human subjects for Children’s Medical Center, Parkland Health & Hospital System, Texas Scottish Rite Hospital for Children, and the University of Texas Southwestern Medical Center at Dallas. The Board also reviews all research conducted at the Presbyterian Hospital of Dallas, The Retina Foundation of the Southwest and the Veteran’s Affairs Medical Center of Dallas for which a member of the faculty at UT Southwestern serves as principal investigator. 2Title printed on the cover of the protocol, including the sponsor’s protocol number, version, and date 3Complete name of the organization(s) funding the research 4Available as an electronic file at http://www8.utsouthwestern.edu/utsw/cda/dept31018/files/41623.html


Assurances of Department and Collaborating Chairmen

• I understand that responsibility for assessing the quality of research must be shared by both the department and the IRB.

• My signature certifies that I assure compliance with the ethical principles and institutional policies regarding the protection of human subjects in research as stated in Title 45 Code of Federal Regulations Part 46 (revised June 18, 1991; reprinted April 2, 1996) and the Federal Wide Assurance, and that I have reviewed the proposed research for the proper use of human subjects.

• This review encompassed experimental design, scientific merit, and accuracy of the proposed research.

Date of Application: September 13, 2009


Investigators’ and Chairmen’s Signatures Name (printed) Dept Degree Rank Phone Mail E-mail Signature

Principal Investigator (PI)5 William Lodrigues MS WHCNP-BC

Oncology MS NP 214-590-1551 7208 wlodri@ parknet.pmh.org

(Faculty Sponsor)6 Roshni Rao

Surgical oncology MD Ass Prof 214-648-7573 9155 roshni.rao@

utsouthwestern.edu

Research Coordinator7 William Lodrigues MS WHCNP-BC


Primary Administrative Contact8 William Lodrigues MS, WHCNP-BC


Co-Investigator Julie Dreadin MS, WHCNP-BC

Oncology MS NP 214-590-5582 7208 jdread@ parknet.pmh.org

Co-Investigator Lisa Lilley MS, WHCNP-BC

Oncology MS NP 214-590-5582 7208 lbill@ parknet.pmh.org

Consultant

Peggy Mancuso PHD OB/GYN Phd Ass Prof.

TWU 214-689-6552 7208 [email protected]

Department Chairperson9 Robert Rege MD

Surgery Oncology MD Prof 214-648-3050 9031 robert.rege@

utsouthwestern .edu

Please note that to qualify for expedited review, the research must present no more than minimal risk to human subjects and cannot explore sensitive topics. Designate below the category that qualifies this proposal for expedited review, and justify this designation by responding to the statements below each category.

5Investigator responsible for the global aspects of the research. The IRB acknowledges one PI for a study. 6If the PI is not a member of the University faculty, a faculty member is required to serve as “faculty sponsor” of the research. Leave blank if the PI is a member of the University faculty. 7Person designated by the PI to report information about the research to the IRB and the person to whom all correspondence from the IRB will be sent. 8Optimal: Person designated to receive IRB correspondence in addition to the PI and RC. 9Chairman of the PI’s or faculty sponsor’s department (or center director).


(Click on, http://www8.utsouthwestern.edu/vgn/images/portal/cit_56417/13/61/69669expcategories.pdf for a list of “Expedited Categories.) The IRB will review your justification and decide if this study can be approved on an expedited basis. If it is decided that it doesn’t meet expedited criteria completely, then you will be informed and submission of an NR1 form will be necessary. Category #: Information Required for Justification (specific information in attachments):

1. Fast Fact Sheet

2. Protocol Summary 1. PROBLEM UNDER INVESTIGATION: Medical condition or scientific problem to be studied: Pain associated with pre-surgical localization of a nonpalpable breast lesion. Describe the research in simple language by attaching a project summary (template available on the IRB web-site). If this is a retrospective chart review (Category 5) (health records research) all of the following must be addressed: a) describe specifically what data (variables) will be extracted from each medical record, whether or not subject identifiers (name, medical record number, social security number, etc.) will be present, and at what point in time identifiers (if used) will be destroyed. Clarify how subject confidentiality will be protected. b) State why the research could not practicably be carried out without access to and use of the protected health information.


2. SUBJECTS: a) General Inclusion: Any female patient that is 18 years of age or older and scheduled for pre-surgical localization of a nonpalpable breast lesion at Parkland Hospital between October 1, 2009 and February 28, 2010 may be included in the study. Approximate number of subjects: 50 Age range (indicate whether months or years): 18 years and older Gender: Male ( ) Female (x ) Explain below if either gender is excluded: This study will exclude male subjects due to the focus on female pain associated with presurgical localization of a nonpalpable breast lesion of the female breast. Will all racial/ethnic groups be included? Yes (x) No ( ) (If no, explain in project summary) Please note that a consent document in the subject’s own language will need to be provided. Expected time to completion of enrollment or conclusion of study: The time to completion of enrollment will be between October 1, 2009 and March 28, 2010. b) Protocol inclusion criteria: Any female patient that is 18 years of age or older and scheduled for pre-surgical localization of a nonpalpable breast lesion at Parkland Hospital c) Protocol exclusion criteria: The exclusion criteria consist of patients with chronic pain, currently on narcotics, unable to read English or Spanish or patients with altered mental status. There are no exclusions based on race, ethnic background, life expectancy, nutritional status or performance status. Specify all classes of subjects included in the research: Healthy volunteers: Medical students ( ), Center employees ( x ), Minors (<18 yrs) ( ), Men ( ), Women ( x ) Patients: Outpatients ( x ), Inpatients ( ) Vulnerable Subjects: Pregnant women ( ), Minors (<18 yrs) ( ), Men ( ), Women ( x ) Cognitively impaired ( ), Terminally ill ( ), etc. Other: Other class ( ) please explain below 3. RECRUITMENT:


Specify procedures for recruiting subjects: This is a prospective nonrandomized research study utilizing a one page questionnaire. Patients will be asked to participate in the study during the pre-operative visit one week prior to the procedure. Informed consent will be obtained when the patients agrees to participate in the study by filling out the questionnaire, the day of the procedure. Patients will be identified by the Parkland Hospital surgical oncology operating room schedule. After the patients are identified, William Lodrigues MS, WHCNP-BC, Lisa Lilley MS, WHCNP-BC or Julie Dreadin MS, WHCNP-BC will review patient’s chart for information in the standard of care; no treatment decisions will be made based on this data. This information provided by the patient will be collected and moved into a database that only William Lodrigues MS, WHCNP-BC will have access to. 4. CONSENT OF SUBJECTS: Describe the method used to obtain informed consent. Prospective research ordinarily requires written informed consent. If any special subject classes are eligible to participate, discuss how the consent process will differ. Inclusion of children in minimal risk research requires permission of at least one parent and the assent of the child. Informed consent will be explained during the pre-operative process. If a patient agrees to participate in the study, she would sign the informed consent and take the one page questionnaire home. If participation is declined, the process would stop.


If requesting a waiver or alteration of informed consent, justify such in accordance with the following four criteria established under 45CFR46.116(d)(1-4): 1) The research involves no more than minimal risk* to the subjects? Yes (x ) No ( ) AND 2) The waiver or alteration will not adversely affect the rights and welfare of the subjects? Yes (x ) No ( ) AND 3) The research could not practicably be carried out without the waiver or alteration? Yes ( x ) No ( ) AND 4) Whenever appropriate, the subjects will be provided with additional pertinent information after participation? Yes ( x ) No ( ) *“Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests” (45 CFR 46). Please note that the IRB will make the final determination if waiver of consent is appropriate. 5. RISKS AND BENEFITS: Specify the risks and benefits to the subjects and/or society: There is minimal risk with respect to loss of patient confidentiality, although all efforts will be made to minimize risk. There is no direct benefit to patients included in this study. There may be a benefit to society, by identifying pain associated with the pre-surgical localization of nonpalpable breast lesions. This information may help lead to improved control measures for pain associated with the procedures for future patients. 6. RESEARCH PERSONNEL: Is there a conflict of interest between any investigator and the sponsor? Yes ( ) explain below and notify the Conflict of Interest Office No (x) Have all research personnel completed the required human subject protection training?

(x) yes ( ) no

(name(s) and completion date(s) under Comments) (enclosed with current submission)

Have all research personnel (x) yes (name(s) and completion date(s) under


completed the required HIPAA training?

( ) no

Comments) (enclosed with current submission)

Is this study industry sponsored? ( ) yes

(x) no (please skip the next question)

Have all research personnel completed the required Good Clinical Practice training?

( ) yes ( ) no

(name(s) and completion date(s) under Comments) (enclosed with current submission)


7. PERFORMANCE SITES: Specify the sites where (1) study procedures will be conducted, (2) patients will be seen, and (3) resources (equipment, supplies, personnel, etc.) will be utilized. Indicate whether Form NR3 has been sent to the appropriate authority at the performance site.

Performance Site Recruitment Resources Form NR3 sentAston Ambulatory Care Center

Children’s Medical Center

Dallas County Mental Health

Dallas Veteran’s Affairs Medical Center

General Clinical Research Center

Parkland Health & Hospital System x x

Presbyterian Hospital of Dallas

Sprague Clinical Sciences Center

Texas Scottish Rite Hospital for Children

UT Southwestern Medical Center

UT Southwestern Moncrief Cancer Center

UT Southwestern University Hospital-St. Paul

UT Southwestern University Hospital-Zale Lipshy

Other (specify below)

Other approvals needed: Environmental Health & Safety Committee

Radiation Safety Committee

IRB at the Veteran’s Affairs Medical Center

IRB at Presbyterian Hospital of Dallas

Grants Management (UT Southwestern)

General Clinical Research Center

Form NR3

Other (specify below)

Have all approvals been x Yes

requested? no (explain below)


8. OTHER PAPERWORK REQUIRED: a) Project summary including any questionnaires, surveys, telephone scripts, etc. Also, when applicable: b) Complete grant application, with budget (when project is federally funded). Block out confidential salary information and total dollar amount. c) Consent form, information sheet, brochure, and/or letter, script for verbal consent. d) Recruitment materials (e.g., posted notices, advertisements, telephone script, letters, etc.) COMMENTS:


For IRB office use only: Expedited Review: Approved As Submitted Reviewer: IRB Chair or Designee Date: ____________________________ Approved - Minor Changes Reviewer: (may be verified by designee) IRB Chair or Designee Date: ____________________________ Deferred – Substantive Issues Reviewer: (needs IRB Chair approval) IRB Chair or Designee Date: Refer for Full Board Review Reviewer: IRB Chair or Designee Date:


Appendix B

University of Texas IRB Approval Letter


Appendix C

Texas Woman’s University IRB Application


Appendix D

Texas Woman’s University Approval Letter


Appendix E

Project Timeline


Projected Timeline

September 12, 2009 IRB application submitted to the University of Texas, Dallas Medical

Center

September 24, 2009 IRB approval granted from University of Texas, Dallas Medical

Center

October 5, 2009 Successful defense of Capstone project

October 6, 2009 Submission of application for capstone project to Texas Woman’s

University IRB

October 20, 2009 IRB approval granted from Texas Woman’s University

October 30, 2009 Started data collection

February 24, 2010 Conclude data collection and start statistical analysis of data

March 1, 2010 Continue data analysis

March 22, 2010 Completed Capstone project with submission of final paper


Appendix F

Tool (English)


An assessment of pain associated with two pre-surgical localization techniques for non-palpable breast lesions; wire localization and radioactive titanium seed

localization. You are being asked to participate in a research study. This is a voluntary research study and you are not required to complete this questionnaire. The information will not be used for your plan of care. By responding to the questions below, you are consenting to this survey. If you choose to participate in this study please fill out the questions below and bring the questionnaire with you to your post-operative appointment. Thank you for your participation. What is your age? ______ What is your race? Please circle only one answer. Hispanic African American Caucasian Asian Indian Other ______ How many breast biopsies have you had in the past? Please circle only one answer. 1 2 3 4 5 or more Circle the cup size of your bra?

1. A or smaller 2. B 3. C 4. D 5. Larger than D Have you had a wire localization prior to this? Yes No Have you had a seed localization prior to this? Yes No Do you take pain medication on a daily basis? Yes No

Please circle a number below that describes your pain associated with your pre-surgical localization procedure.

________________________________________________________________________ No Pain Distressing Pain Unbearable Pain

0 1 2 3 4 5 6 7 8 9 10 ________________________________________________________________________ McCaffery, M., & Beebe, A. (1993). Pain: clinical manual for nursing practice. Baltimore: V. V. Mosby Company.


Appendix G

Tool (Spanish)


Una evaluación de dolor asociado con dos técnicas de localización pre-quirúrgicas para lesiones de seno no palpables; localización con alambre

y localización con semilla radioactiva de titanio. Se le ha pedido tomar parte en un estudio de investigación. Esto es un estudio de investigación voluntario y usted no necesita completar este cuestionario. La información no será utilizada para su plan de cuidado. Al responder a las siguientes preguntas, usted consiente a esta encuesta. Si usted elige tomar parte en este estudio por favor conteste las preguntas de abajo y preséntese con el formulario completo a su cita posoperativa. Gracias por su participación. ¿Cuál es su edad? _______ ¿De qué origen es? Por favor marque sólo una respuesta con un círculo. Hispano Afro-Americano Caucásico Asiático Indio Otro________ ¿Cuántas biopsias de seno ha tenido en el pasado? Por favor marque sólo una respuesta con un círculo.

1 2 3 4 5 o más

Marque el tamaño de la copa de su sostén / brassiere con un círculo.

1. A o más pequeño 2. B 3. C 4. D 5. Más grande que D ¿Ha tenido una localización de alambre antes de esto?

Sí No ¿Ha tenido una localización de semilla radioactiva antes de esto?

Sí No ¿Toma medicina para el dolor diariamente?

Sí No Por favor indique con un círculo un número de abajo cual describa su dolor

asociado con su procedimiento de localización pre-quirúrgico. ______________________________________________________________________________ Sin dolor Dolor agobiante Dolor insoportable

0 1 2 3 4 5 6 7 8 9 10 ______________________________________________________________________________


Appendix H

Informed Consent


The University of Texas Southwestern Medical Center at Dallas Children’s Medical Center of Dallas, Parkland Health & Hospital System

Retina Foundation of the Southwest, Texas Scottish Rite Hospital for Children The University of Texas Southwestern Moncrief Cancer Center

Authorization for Use and Disclosure of

Health Information for Research Purposes NAME OF RESEARCH PARTICIPANT: _______________________________________________ What is the purpose of this form? This authorization describes how information about you and your health will be used and shared by the researcher(s) when you participate in the research study: Assessment of pain between two presurgical localization techniques for a nonpalpable breast lesion, to compare the pain associated with these two types of breast localization techniques.(“Research Project”). Health information is considered “protected health information” when it may directly identify you as an individual. By signing this form you are agreeing to permit the researches and other others (described in detail below) to have access to and share this information. If you have questions, please ask a member of the research team. Who will be able to use or share my health information? UT Southwestern Medical Center and Parkland Hospital may use or share your health information with William Lodrigues and his staff at UT Southwestern Medical Center (“Researchers”) for the purpose of this research study. Will my protected health information be shared with someone other than the Researchers? Yes, the Researchers may share your health information with others who may be working with the Researchers on the Research Project (“Recipients”) for purposes directly related to the conduct of this research study or as required by law. These other people or entities include:

The UT Southwestern Institutional Review Board (IRB). This is a group of

people who are responsible for assuring that the rights of participants in research are respected. Members and staff of the IRB at UT Southwestern may review the records of your participation in this research. A representative of the IRB may contact you for information about your experience with this research. If you do not want to answer their questions, you may refuse to do so.

Representatives of the Food and Drug Administration (FDA). The FDA may

oversee the Research Project to confirm compliance with laws and regulations.


The FDA may photocopy your health information to verify information submitted to the FDA by the Sponsor.

Representatives of domestic and foreign governmental and regulatory agencies

may be granted direct access to your health information for oversight, compliance activities, and determination of approval for new medicines, devices, or procedures.

How will my health information be protected? Whenever possible your health information will be kept confidential as required by law. Federal privacy laws may not apply to other institutions, companies or agencies collaborating with UT Southwestern on this research project. UT Southwestern cannot guarantee the confidentiality of your health information after it has been shared with the Recipients. Why is my personal contact information being used? Your personal contact information is important for the UT Southwestern Medical Center research team to contact you during the study. However, your personal contact information will not be released without your permission. What health information will be collected, used and shared (disclosed)? The Researchers will collect information about prior biopsies, current pain status, any chronic pain, and demographics. Will my health information be used in a research report? Yes, the research team may fill out a research report. (This is sometimes called “a case report”.) The research report will not include your name, address, or telephone or social security number. The research report may include your date of birth, initials, dates you received medical care and a tracking code. The research report will also include information the research team collects for the study. Will my health information be used for other purposes? Yes, the Researchers and Recipients may use your health information to create research data that does not identify you. Research data that does not identify you may be used and shared by the Researchers and Recipients in a publication about the results of the Research Project or for other research purposes not related to the Research Project. Do I have to sign this authorization? No, this authorization is voluntary. Your health care providers will continue to provide you with health care services even if you choose not to sign this authorization. However, if you choose not to sign this authorization, you cannot take part in this Research Project. How long will my permission last?


This authorization has no expiration date. You may cancel this authorization at any time. If you decide to cancel this authorization, you will no longer be able to take part in the Research Project. The Researchers may still use and share the health information that they have already collected before you canceled the authorization. To cancel this authorization, you must make this request in writing to: William Lodrigues MS, WHCNP-BC Breast Oncology Clinic 5201 Harry Hines BLVD Dallas, TX 75235 214-590-1551 Will I receive a copy of this authorization? Yes, a copy of this authorization will be provided to you. Signatures: By signing this document you are permitting UT Southwestern Medical Center to use and disclose health information about you for research purposes as described above. Signature of Research Participant Date For Legal Representatives of Research Participants (if applicable): Printed Name of Legal Representative: Relationship to Research Participant: _________________________ I certify that I have the legal authority under applicable law to make this Authorization on behalf of the Research Participant identified above. The basis for this legal authority is: _______________________________________________________________________________________. (e.g. parent, legal guardian, person with legal power of attorney, etc.) Signature of Legal Representative Date


Appendix I

Pain Scale


Please circle a number below that describes your pain associated with your pre-surgical localization procedure.

________________________________________________________________________ No Pain Distressing Pain Unbearable Pain

0 1 2 3 4 5 6 7 8 9 10 ________________________________________________________________________ McCaffery, M., & Beebe, A. (1993). Pain: clinical manual for nursing practice. Baltimore: V. V. Mosby Company.


Appendix J

Statistical Tables


Table J1 Descriptive Statistics for Age and Pain with Pre-Surgical Localization Procedure by

Localization Type

Localization Type Age Pain Pre-Surgical

Seed N 11 11

Mean 56.55 2.27

Std. Deviation 13.794 1.679

Minimum 40 0

Maximum 82 5

Percentiles 25 46.00 1.00

50 53.00 2.00

75 65.00 3.00

Wire N 14 14

Mean 47.64 3.86


Minimum 22 0

Maximum 77 9

Percentiles 25 39.75 .75

50 43.00 4.00

75 55.25 5.50

Groups Combined N 25 25

Mean 51.56 3.16


Minimum 22 0

Maximum 82 9

Percentiles 25 41.50 1.00

50 50.00 3.00

75 61.50 5.00


Table J2 Correlation Between Pre-Surgical Pain and Brassiere Size

The correlation between pain pre-surgical and brassiere size was non-significant

(Kendall’s tau-b, p=0.794).

Value Error Approx. T Approx. Sig.

Nominal by Nominal Cramer's V .600 .284

Ordinal by Ordinal

Kendall's tau-b .048 .181 .261 .794

Kendall's tau-c .044 .168 .261 .794

Gamma .061 .233 .261 .794

Somers' d .047 .179 .261 .794

N of Valid Cases 25


Table J3 Categories for Brassiere Size Collapsed Categories

Brassiere Size Pain

Total 0-2 3-5 6-10

1-2 2 5 0 7

3 7 5 1 13

4-5 2 1 2 5

Total 11 11 3 25

Correlation between Pain Pre-Surgical and Collapsed Categories of Brassiere Size

Correlations

(Kendall’s tau-b, p=0.874)

Value Error Approx. T Approx. Sig.

Nominal by

Nominal Cramer's V .372 .139

Ordinal by Ordinal

Kendall's tau-b .032 .199 .159 .874

Kendall's tau-c .029 .181 .159 .874

Gamma .049 .307 .159 .874

Somers' d .032 .199 .159 .874

N of Valid Cases 25

pre-surgical localization 1 running head: pre-surgical localization

Documents