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Arvidson-Hawkins, Deborah M.
A comparison of systolic blood pressure in women with and without lymphedema following surgery for breast cancer
h [electronic resource] /
by Deborah M. Arvidson-Hawkins.
[Tampa, Fla] :
b University of South Florida,
ABSTRACT: There is no evidenced-based research on prevention of upper extremity lymphedema following breast cancer treatment. General guidelines have been identified from a basic understanding of the lymphatic system and are considered to be prudent advice for prevention. Cause of lymphedema is hypothesized to be multifactorial and time of onset is widely varied. Exogenous risk factors leading to lymphedema are the removal and destruction of lymph nodes; however, not all women develop lymphedema following axillary lymph node dissection. Co-morbid conditions such as obesity, diabetes, and hypertension are cited as possible endogenous risk factors. Several studies identify hypertension as a significance endogenous risk factor resulting in increased capillary filtration causing an increase in the fluid load on an already compromised lymph drainage system. This retrospective chart review was designed to compare systolic blood pressure in two matched groups to determine if there is a dif ference between groups. The study population included 147 stage ii and iii breast cancer patients. after receiving irb approval, charts of patients with a diagnosis code oflymphedema (n=19) were identified from the 147 possible charts. A matching sample of 18 women without lymphedema was assembled. Vital sign records were then reviewed and 3 measures of systolic blood pressure were used from a time period of two to 15 moths after lymph node dissection. Results revealed mean age and number of lymph nodes removed in the two groups were equivalent. No significant difference in systolic blood pressure was found between the two groups. However, he study was limited by the lack of chart data on the variables of lymphedema and systolic blood pressure. This pilot study pointed out adjustments needed to capture a more diverse sample. Other limitations such as missing demographic data on race, number of participants treated with radiation to the axilla and records of ambulatory blood pressure s hould be included in future studies.
Thesis (M.A.)--University of South Florida, 2006.
Includes bibliographical references.
Text (Electronic thesis) in PDF format.
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Adviser: Susan C. McMillan, Ph.D, ARNP.
t USF Electronic Theses and Dissertations.
4 0 856
A Comparison of Systolic Blood Pres sure in Women With and Without Lymphedema Following Surgery for Breast Cancer by Deborah M. Arvidson-Hawkins A thesis submitted in partial fulfillment of the requirements for the degree of Master of Science College of Nursing University of South Florida Major Professor: Susan C. McMillan, Ph.D., ARNP Cecile Lengacher, RN, Ph.D. Janine Overcash, Ph.D., ARNP Date of Approval July 18, 2006 Keywords: Co-morbidities, Hypertension, Microcirculation, Secondary Lymphedema, evidence-based research Copyright 2006, Deborah M. Arvidson-Hawkins
i Table of Contents List of Tables iii Abstract iv Chapter I: Introduction 1 Problem and Purpose 4 Research Question 5 Definition of Terms 5 Significance 6 Chapter II: Review of Literature 7 Incidence and Prevalence of Lymphedema 7 Diagnosis of Lymphedema 8 Subjective Measurements 8 Objective measurements 9 Time of Onset of Lymphedema 10 Risk Factors for Lymphedema 10 Surgery and Radiation Therapy 10 Co-morbidities 10 Elevated Blood Pressure as a Modifiable Risk Factor 11 Definition of Elevated Blood Pressure and Hypertension 12 Prevalence of Hypertension 12 Summary 13
ii Chapter III: Methods 15 Population, Sample and Setting 15 Inclusion Criteria 15 Exclusion Criteria 16 Study Variables 16 Procedures 16 Data Analysis 17 Chapter IV: Results, Discussion and Conclusions 18 Results 18 Sample 18 Stages of Hypertension Among Groups 19 Systolic Blood Pressure and Lymphedema 19 Discussion 20 Sample 20 Stages of Hypertension Among Groups 22 Systolic Blood Pressure and Lymphedema 22 Conclusions 23 Recommendations for Future Research 23 References 24 Appendix A: Letter of IRB Exempt Certific ation 29
iii List of Tables Table 1. Mean Age and Number of Nodes Removed 18 Table 2. Study GroupÂ’s Hypertensi on Classification By JNC VII Guidelines 19 Table 3. Independent t test Comparison of Mean Systolic Bl ood Pressure 20
iv A Comparison of Systolic Blood Pres sure in Women With and Without Lymphedema Following Surgery for Breast Cancer Deborah M. Arvidson-Hawkins ABSTRACT There is no evidenced-bas ed research on prevention of upper extremity lymphedema following breast cancer treatment. General guidelines have been identified from a basic understanding of the lymphatic system and are considered to be prudent advice for prevention. Cause of lymphedema is hypothesized to be multifactorial and time of onset is widely varied. Exogenous ri sk factors leading to lymphedema are the removal and destruction of lymph nodes; however, not all women develop lymphedema following axillary lymph node dissection. Co -morbid conditions such as obesity, diabetes, and hypertension are cited as possibl e endogenous risk factors. Several studies identify hypertension as a si gnificance endogenous risk fact or resulting in increased capillary filtration causing an increase in the fluid load on an already compromised lymph drainage system. This retrospective ch art review was designed to compare systolic blood pressure in two matched groups to de termine if there is a difference between groups. The study population included 147 stage II and III breast cancer patients. After receiving IRB approval, charts of pa tients with a diagnosis code of
v lymphedema (n=19) were identified from th e 147 possible charts. A matching sample of 18 women without lymphedema was assembled. Vital sign records were then reviewed and 3 measures of systolic blood pressure we re used from a time period of two to 15 moths after lymph node dissection. Results revealed mean age and number of lymph nodes removed in the two groups were equivale nt. No significant difference in systolic blood pressure was found between the two gr oups. However, he study was limited by the lack of chart data on the vari ables of lymphedema and systol ic blood pressure This pilot study pointed out adjustments needed to capture a more diverse sample. Other limitations such as missing demographic data on race, number of participants treated with radiation to the axilla and records of ambulatory blood pressure shou ld be included in future studies.
1 Chapter I Introduction As part of the surgical treatment and staging of br east cancer, axillary lymph nodes that drain the breast are removed. When choosing the best adjuvant treatment for individual patients, an impor tant factor to consider is the number of lymph nodes involved with cancer. Axillary lymph node stat us is an important prognostic factor for patients with breast cancer; however, this proc edure is associated with considerable morbidity (National Comprehensive Cancer Network [NCCN], 2005). Lymphedema is among the most visible side e ffects after treatment for br east cancer. Lymphedema can occur in any quadrant drained by the affected nodal bed leading to truncal edema, breast edema or upper extremity edema (Muscari, 2004 ). The surgical technique of sentinel lymph node biopsy has been shown to be an e ffective alternative to complete axillary lymph node dissection for stagi ng of breast cancer. However, if sentinel lymph nodes are found to be involved with cancer, a comple te axillary node dissection is necessary (NCCN, 2005). Lymphedema is a condition th at can be treated and managed over a lifetime but cannot be cured. Problems associated with lymphedema are pain, discomfort, disability, alteration in body im age, and difficulty fitting clothing (Ridner, 2002). The number of reported occurr ences of lymphedema varies widely; this may be due to the fact that definition and measurem ent vary substantially among studies. A study
2 done by Kwan et al. (2002) reported approxi mately 50% of patients screened were symptomatic and 12.5% of those screened ha d measurable lymphedema. Petrek, Senie, Peters, and Rosen (2001) reported that approximately 400,000 women cope with lymphedema on a daily basis. In another clin ical study on incidence a nd risk, one in five of the study sample developed lymphe dema. Of those women, 80% developed lymphedema by one year post surgery (Clark & Harlow, 2005). In a cohort study over a twenty-year time period, Petrek, et al. ( 2001) found that out of 263 women, 77% reported swelling within 3 years of dia gnosis, and the remaining women developed symptoms gradually over the subsequent 17 ye ars. Studies vary on the percentages of women who develop lymphedema, but they agree that in the majority of women lymphedema develops more often during the fi rst three years after surgery, and incidence tapers in years to come. Lymphedema occurs when ar terial capillary filtration exceeds lymphatic transport capacity. Fluid is continuously f iltered from the capillaries in to the interstitium. Ninety percent of the fluid is reabso rbed into the venous system; te n percent of that fluid is filtered and transported from the interstitium by the lymphatic system back to the vascular system (Ridner, 2002). Transpor t capacity is diminished by removal or destruction of lymph nodes. On ce there has been an excision a nd/or radiation to the nodal basin, the capacity to transport and filter the ly mphatic load is curtailed. This results in a reduced capacity to transpor t and filter protein, water, metabolic wastes, viruses and bacteria. Any further overloading of the trans port capacity has the poten tial to trigger the onset of chronic lymphedema (Schuch, 2001). Lymphedema is not simply lymphatic obstruction; it is a complex sequence of even ts, and research is needed throughout this
3 evolving process. Evidence suggests hemodynamic factors, if not causal, may contribute to lymphedema (Mortimer, 1998). In addition to diminished transport capacity, studies have shown that there is an increase in bl ood flow to the edematous arm when compared to the non-edematous arm. This may lead to in creased capillary filtration into an arm with impaired lymphatic transport capacity (Bates, Levick & Mo rtimer, 1994; Stanton, Levick & Mortimer,1996). Studies have identified hypertensi on as a possible contributing factor to lymphedema; and treatment for hyperten sion was found to be a protective factor (Bates, et al., 1994; Deo, et al., 2004; Engel, Kerr, Shlesinger-Raab, Sauer, & Holzel, 2003; Geller, Vecek, OÂ’Brien, & Secker-W aler, 2003; Herd-Smith, Russo, Grazia Muraca, Rosselli Del Turco, & Cardona, 2001). One limitation to thes e studies is that, like the definition of lymphedema, the defi nition of hypertension varies among studies. Consideration of the damage to the lymphatic system along with hemodynamic factors is an important step to understanding potential risk factors of lymphedema after treatment for breast cancer (Ridner, 2002). Published clinical practice guidelines for lymphedema offer suggestions to prevent lymphedema based on interventions that make clinical sense, although the evidence supporting their suggestio ns is limited and anecdotal (Harris, Hugi, Olivotto, & Levine, 2001). The National Lymphedema Network (NLN) has published prevention guidelines; these guidelines ar e a listing of prudent advice based on a basic understanding of the lymphatic system (Schuch, 2001). The NL N guidelines have been strengthened and updated since they were first published in 1990 to reflect the current level of knowledge in the world of lymphology. However, it is noted that the lack of evidence-based data continues to make it difficult to jus tify these guidelines (Thiadens, 2005).
4 There have been no randomized controlled trials or cohort studies to provide evidence based interventions designed specifi cally to prevent lymphedema after breast cancer treatment (Erickson, Pearson, Ganz, Adams & Kahn, 2001). In the absence of evidence-based prevention measures, NLNÂ’s ri sk reduction guidelines should be included in patient teaching when explaining precauti ons that may reduce risk of lymphedema (Ridner, 2002). Problem and Purpose After axillary lymph node dissection, s econdary upper extremity lymphedema may develop, once established, it is a chronic and incurable morbidity of treatment. It is imperative for patients to be aware of thei r lifelong risk of deve loping lymphedema to enable them to make informed decisions (R idner, 2002). There is a lack of evidencebased research and interventions to preven t lymphedema after breast cancer surgery. Prevention and physical therapy are the focu s when teaching patients about lymphedema (Muscari, 2004). Health care practitioners find it difficult to provide patients with estimates of their chances of developing ly mphedema or when lymphedema can most likely occur (Erickson et al., 2002). The presence of hypertension has been show n to be a signific ant factor in the development of lymphedema after treatment fo r breast cancer (Deo, et al., 2004; Engel, et al. 2003; Geller, et al., 2003). However, stan dards for the definition of hypertension are not consistent across studies. The purpose of this study was to explore the relationship between elevated blood pressure and the deve lopment of lymphedema in women treated for breast cancer.
5 Research Question The following question was the focus of this study: Is there a significant difference in the mean systolic blood pressure between two matched samples, one with and one without lymphedema, within the first 15 months following treatment for breast cancer? Hypothesis: Women with a diagnosis of lymphedema will experience an increased prevalence of elevated systolic blood pressure compared to a matched sample of women without lymphedema. Definition of Terms Secondary upper extremity lymphedema is defined as the accumulation of lymph fluid in the arm and/or hand after surgical removal of lymph n odes and/or radiation therapy as treatment for breast cancer. (Corni sh et al., 2000). For the purposes of this retrospective chart review, a documented diagnosis of lymphedema evidenced by a diagnosis code for lymphedema in the patien t chart defined the pr esence of lymphedema. Hypertension is defined by the Sevent h Report of the Joint National Committee on Prevention, Detection, Evaluation, and Tr eatment of High Blood Pressure in stages Pre hypertension is a systolic BP of 120-139 or a diasto lic BP of 80-89; stage 1 hypertension is a systolic BP of 140-159 or diastolic BP of 90-99; stage 2 hypertension is a systolic BP of > 160 or a diastolic BP of > 100. Blood pressure is considered elevated if systolic BP is increased by 20mmHg or if diastoli c BP is increased by 10mmHg based on the mean of two or more BP readings on each of two or more office visits (Chobanian et al., 2003).
6 Significance At this time, there is no evidenced-based re search available for clinicians to teach their patients on prevention of lymphedema Since lymphedema may occur immediately after surgery or later in life, there is a need to teach life-long precautions. These precautions require considerable lifestyle m odifications for an undefined amount of time. Clinicians struggle with standa rds of care that are not evid ence-based and the need to teach effective prevention measures (Muscari, 2004). This study may shed light on the importance of recognizing elevated blood pre ssure and controlling hypertension as one evidence-based method for preventing or controlling lymphedema.
7 Chapter II Review of Literature This chapter reviews and summarizes current knowledge of the incidence, prevalence, diagnosis, time of onset, and risk factors of secondary upper extremity lymphedema following treatment for breast cance r. This review of literature focuses on type of cancer treatment and co-morbidities which are risk factors for developing breast cancer related upper extremity lymphedema The chapter concludes by reviewing elevations in blood pressure as a possible modifiable risk factor in need of further study. Incidence and Prevalence of Lymphedema In a review of literature from 1985 to 1999, Erickson, Pearson, Ganz, Adams, and Kahn (2001) reported incidence of lymphedema varied with surgical procedure, breast cancer therapy, definition of lymphedema and time from surgery to onset of lymphedema. Estimates of the incidence of lymphedema range from 6% to 86 % (Clark, Sitzia, & Harlow, 2005). The American Cancer Society estimates that there will be 212,920 new cases of invasive breast cance r diagnosed in 2006 (American Cancer Society [ACS], 2005). At best, 12,775 of t hose women will develop lymphedema and at worst, 183,111 will develop lymphedema after treatment for breast cancer. In a retrospective analysis conduc ted over a 15 month time frame, Deo et al. (2004) found the prevalence of clinically signi ficant lymphedema was 13.4% for patients who were treated with surgery alone and 42.4% for patients treated with surgery and radiation.
8 Diagnosis of Lymphedema The diagnosis of lymphedema is genera lly made by medical history and physical exam. There are a wide range of subjec tive and objective evaluation methods; the methods most used are patient questionnaire, sequential circumferential measurement and volume measurement. A limitation of the re search reviewed is that there is no standardization of measurement or consiste ncy in methods of measurement (Erikson et al., 2001). Subjective Measurements Patient reported symptoms and questionna ires are often used to determine the presence and complications of lymphedema. Qu estionnaires were used by researchers in a study to assess the nature and se verity of arm complaints as well as to determine if they interfere with activities of daily life, ps ychosocial functioning, and quality of life (Ververs et al. 2001). Considerable t hought and planning to test and validate questionnaires is necessary (Norman, M iller, Erikson, Norman, & McCorkle, 2001). A number of studies have used questionnai res along with telepho ne interviews; comorbidities were not the focus of these met hods. Qualities of life, impact on daily life, and severity of symptoms ha ve been measured. Questions on co-morbidities present at the time of onset of lymphedema, specifically hypertension, were not analyzed in these questionnaires (Vevers et al., 2001; E ngle et al., 2003; Goffman et al., 2004). Objective Measurements Objective measures have varied as well, most studies have relied on sequential circumferential arm measurements because this is a simple, cost e ffective, reproducible and reliable method to define and determin e the presence of lymphedema. However,
9 quantification varies among studies. In one study the definition was determined to be a finding of greater than or equal to a two cen timeters difference in the circumference of the affected and non-affected arm (Armer & F u, 2005). In another, the difference of three centimeters between arms (Deo et al., 2004), an d still another considered a difference of greater than five percent be tween arms (Herd-Smith, 2001). Points of measurement also have varied, circumference measurements have been taken at various intervals from the hand to the shoulder. Some used anatomical points on the arm, others measured from anatomical points on the arm. The simplest method used the elbow as the point of reference and recorded three areas to be m easured at predetermined distances from the elbow (Petrek et al., 2001). Because of differences in the methods used to determine the presence of lymphedema, the numbers have varied wide ly, and prevalence of lymphedema after treatment for breast cancer is difficult to determine. In addition, distribution of swelling in the affected arm is often uneven and can develop anywhere be tween the shoulder and the hand (Stanton et al., 2001). The definition of secondary lymphedema after treatment for breast cancer varies among studies; in some studies subjective findings are enough while in others they are accompanied by objective findings. Time of Onset of Lymphedema Four patterns of acute lymphedema have been identified: the first, occurring within a few days of surgery; the second, si x to eight weeks postope ratively; the third, after insect bite or burn; and the fourth, is usually insidiou s having a variable onset about eighteen to twenty-four months after surger y (Lymphedema PDQ, 2005). In an effort to identify prevalence, time of onset, and a ssociated predictive factors related to
10 lymphedema, Petrek, Senie, Peter, and Ro sen (2001) conducted a cohort study spanning a 20 year time period. They found that the interv al to onset of lymphedema symptoms was reported by 77% of the cohort to have occu rred within the firs t three years after treatment. The subsequent rate was 1% per year. Herd-Smith, et al (2001) found that the cumulative probability of lymphedema reached 10% in the two years following surgery. Results of a cohort study conducted over an ei ght year time frame by Geller et al. (2003) estimated a cumulative incidence of lymphedema at one year to be 18% and 35% at two years. They compared their findings with those of Kiel and Rademaker who found a cumulative incidence of 8% at one y ear and 35% at 20 months follow-up. Risk Factors for Lymphedema Surgery and Radiation Therapy Surgery and radiation therapy are th e main known causative factors for lymphedema following treatment for breast can cer. A review of literature from 1985 to 1999 showed that axillary node dissection and/or axillary radiation therapy were found to carry the highest risk for lymphedema as well as pain, paresthe sias, weakness, and impaired shoulder function (Erickson, et al., 200 1). In a retrospective cohort study over a three year time period no patient with fe wer than five nodes removed developed arm edema (Goffman, et al., 2004). Co-morbidities Co-morbidities have emerged as signifi cant risk factor for lymphedema following treatment for breast cancer. Co-morbidities focused on by clinical studies have been obesity, diabetes, and hyperten sion; research has identified treatment for hypertension to be a protective factor. Geller et al. (2003) noted significant decr eased risk of arm
11 swelling among women who were on treatmen t for hypertension. Bohler et al. (1992) noted that the incidence of lymphedema after treatment with axillary surgery and irradiation was 35% among patients with normal blood pressure or controlled hypertension, and 61 percent for patients with hypertension (p<0.005). Engle et al. (2003) found that hypertension and diabetes we re significant contributors to lymphedema (p<0.003). Petrek et al. (2001) collected data on the presence or absence of comorbidities. The two most common chronic illn esses of the cohort were diabetes mellitus 11% and hypertension 17.5%; no mention of how chronic illness effects risk of lymphedema was made. Elevated Blood Pressure as a Modifiable Risk Factor Studies have shown that hypertension may be a risk factor for lymphedema and hypertension is a prevalent health probl em among women in the United States. Cardiovascular disease (CVD) claims the li ves of more women than breast cancer. A Harris poll commissioned by the American Hear t Association in 2003 revealed that only 13 percent of American women believed that C VD presents the greatest health threat to women (American Heart Association [AHA ], 2004). The pathophysiology of the development of lymphedema involves addi tional mechanisms other than lymphatic damage (Bates et al., 1994). Lymphedema depends on fluid capill ary filtration to the affected arm as well as the inability to tran sport fluid due to removal and/or destruction of lymph nodes. Studies have indicated that angiogenesis occurs in the skin of the affected arm after treatment for breast cancer and that increased capil lary surface area for filtration could result in an increase in fl uid load on an already compromised lymph drainage system (Stanton, Levick, & Mo rtimer, 1997). Angiogenesis has also been
12 hypothesized as a contributing factor (Sta nton et al., 2001) Consideration of the hemodynamic factors as well as the damage to the lymphatic system is key in understanding the pathophysiology of lymphedema (Ridner, 2002) Definition of Elevated Blood Pressure and Hypertension The Seventh Report of the Joint Natio nal Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pr essure (JNC VII) was commissioned in response to the need to update guideline s on hypertension. The new guideline added prehypertension as a category for the classi fication and management of hypertension. A systolic blood pressure of 120 to 139 mmHg or diastolic blood pressure of 80 to 89 mmHg are now considered pre-hyper tension. If blood pressure is > 20/10mmHg above goal blood pressure, consideration should be gi ven to initiating ther apy. It is estimated that among people age 18 to 74 years old, 30% are unaware they have hypertension (Chobanian, et. al, 2003). Prevalence of Hypertension In the United States hypertension (HTN) is the most common primary diagnosis comprising 35 million offices visits in the ye ar 2000. In 2003 CVD was the first listed diagnosis of 3,196,000 women discharged (bot h alive and dead) from short-stay hospitals. Of those women, 299,000 women were diagnosed with HTN and 31,065 women died from HTN. Before age 45 the incidence of HTN is greater in men than women; by age 45 to 54 this trend changes. In 2003, women repres ented 53.1 percent of deaths related to CVD in the United Stat es (AHA, 2004). Between the years of 1999 and 2002, the U.S. Department of Health and Huma n Services estimated the percentage of women with elevated blood pr essure or who are taking an tihypertensive medication by
13 age group as; 15.1% among ages 35-44, 31.8% among ages 45-54, 53.9% among ages 55-64, 72.7% among ages 65-74; and women age 75 and over have an 83.1% chance of having elevated blood pressure or will be taking antihypertensive medications(AHA, 2004). It is logical to assume that in many subjectsÂ’ elevatio ns in blood pressure and the diagnosis of true hypertension is missed by clinical blood pressure assessment alone. Studies show ambulatory blood pressure mon itoring to be effective in determining hypertension. Conversely, elevati ons in blood pressure and hear t rate during a clinic visit (white coat hypertension) may be misinterpreted (Paolo et al., 2004). A limitation of the studies reviewed was that am bulatory blood pressure (ABP) is not considered. In future prospective studies ABP should be evaluated to detect isolated ambulatory hypertension and effects of white coat hypertension. Summary Surgery and radiation therapy are the pr imary insults to the axillary lymphatic system and are presumably the root cau se of lymphedema by reducing the lymph transport capacity. The status of the axil lary lymph nodes is an important prognostic indicator and is used to direct choices of adjuvant therapy fo r patients with breast cancer. Since there is no cure for lymphedma, the combination of axillary dissection and radiotherapy should be avoided when feas ible. Although less extensive surgeries have been developed such as sentinel lymph node biopsy, if the sentin el nodes are involved with disease, complete axillary dissec tion often follows (NCCN, 2005). The wide variation in reported occurrenc es of lymphedema may be due to varied procedures for diagnosing lymphedema (Ridne r, 2002). Studies have chal lenged the assumption of a higher prevalence of lymphedema and re lated symptoms among older versus younger
14 breast cancer survivors. Armer and Fu (2005) found that the occurrence of lymphedema was 30.6% for women older than 60 and 41.2% for women younger than 60. Study findings suggest the po ssibility of hypertension as a modifiable risk factor, considering increased venous pressure and increa sed capillary filtration in an arm that has been compromised by the removal or destruct ion of lymph nodes. The studies reviewed showed four significant factors contributed to arm problems: extent of axillary surgery, radiation therapy to the axilla, younger age, and co-morbidities, specifically hypertension. New guidelines on the definition of hypertension tell us that we need to reevaluate which patients we consider to be hypertensive. A Harris poll tells us that women are not recognizing hypertension as a condition more dangerous than breast cancer (AHA, 2004). The presence of elevations in blood pressure or hypertension is often a secondary concern in the shadow of a diagnosis of cancer. Th e role that treatment for high blood pressure may play in protecting women from lymphedema needs further study. This study explored elevations in blood pr essure as a possible modifiable risk factor for secondary upper extremity lymphedema.
15 Chapter III Methods This was a retrospective case matche d study conducted by chart review. This section outlines the research methods used to explore the relationshi p between elevations in blood pressure and the development of secondary upper extremity lymphedema following treatment for breast cancer. First, population, sample, characteristics of the sample, inclusion and exclusion criteria are described. Second, procedures for collecting data are presented. Finally, the met hod of data analysis is discussed. Population, Sample and Setting The target population included medical records of patients treated for breast cancer at a National Cancer Institute-designat ed cancer center located in the southeastern United States. The sample consisted of medi cal records of Stage II and III breast cancer patients. All women who met study criteria were evaluate d. Those records were then matched with medical records of women who had not been diagnosed with lymphedema. A sample of 50 women was sought. Inclusion Criteria Data were collected from charts of patie nts who had been diagnosed with Stage II or III breast cancer and had a lymph node di ssection as part of treatment for breast cancer. Surgical procedures included were ; lumpectomy and/or mastectomy with node
16 dissection of 5 or more lymph nodes, wo men who had a contra-lateral prophylactic mastectomy without lymph node di ssection were al so included. Exclusion Criteria Patients who had had bilateral lymp h node sampling or dissection, a prior diagnosis of breast cancer, history of prio r surgery for breast can cer or benign breast disease with a lymph node dissection in the affected arm, metastatic cancer, or have developed metastasis during the first three ye ars were excluded from the chart review. Patients without complete medical records we re not included in th is chart review. Study Variables Data included pre-operative age, systo lic blood pressure, and number of lymph nodes removed. Interval systolic blood pre ssure was collected from 1 month up to 15 month time frame. Charts were matched by age and number of axillary nodes removed. Procedures The study plan was approved by the Co mprehensive Breast Cancer Program Leader and the Moffitt Scientific Review Committee. Following those approvals, the proposal was approved by the Institutional Re view Board (IRB) of the University of South Florida. Waiver of informed consen t was given (Appendix A). With the approval of the IRB, data collection began. A chart review was conducted by the prim ary investigator ov er a three week period. No patient names, da tes of birth, medical record numbers or other personally identifiable information was collected. All records were included that met the requirements for the group; within that gr oup, diagnosis codes were used to find women with a diagnosis of lymphedema and the group without the diagnos is of lymphedema.
17 Medical records were reviewed at a secure computer terminal at the Moffitt cancer research center. Biographic data was reviewed in Power Chart, collected and recorded on the bioform. Data were directly entered in to an Excel database and SPSS software was used in the analysis of the data. Data Analysis The two groups in this study were matc hed by key characteristics of age and number of lymph nodes removed. To determine if there is a difference in mean systolic blood pressure between the lymphedema gr oup and the non-lymphedema group a t-test was used to compare the means of the systolic blood pressures.
18 Chapter IV Results, Discussion and Conclusions This chapter presents study findings and disc ussion of the data. It begins with an initial discussion of demographic data and contin ues with analysis of data as it relates to the research questions. The chapter concl udes with recommendations for further study. Results Sample The sample consisted of 147 Stage II and III breast cancer patients who were surgically treated with axillary lymph node dissection from January 2000 to January 2003. From that sample 27 patients developed lymphedema within the first 36 months; 19 of the 27 met the lymphedema group inclusi on criteria, these were matched with 18 patients with no diagnosis of lymphedema. Mean age and number of lymph nodes dissected were equivalent between groups(Table 1). Table 1. Mean Age and Number of Nodes Removed Mean Mean Number of n Age SD Nodes Removed Range SD ________________________________________________________________________ Lymphedema 19 55.6 7.9 17.8 9-27 7.8 Non-Lymphedema 18 55.8 7.6 18.2 8-33 5.6 ________________________________________________________________________
19 Stages of Hypertension Among Groups The systolic blood pressures for both gr oups were evaluated for fit into the hypertension classifications set by the JNC V II guidelines. Although most patients fit into the Pre-HTN classification, some patients in ea ch group were classifi ed as having Stage 1 or 2 hypertension (Table 2). Table 2. Study Groups Hypertension Classi fication By JNC VII Guidelines Lymphedema Non-Lymphedema Frequency Percent Frequency Percent _______________________________________________________________________ Pre-HTN 17 89.4 14 77.7 Stage 1 HTN 1 5.3 2 11.1 Stage 2 HTN 1 5.3 2 11.1 Total 19 100 18 99.9 ________________________________________________________________________ Systolic Blood Pressure and Lymphedema To answer the research question, is ther e a significant difference in the mean of the systolic blood pressures between two matched samples, one with and one without lymphedema, systolic blood pressures were compared. Three systolic blood pressures documented during three clinic vi sits at least two months apar t were used were used to determine if there was a difference betw een groups. The time frame was from two months after lymph node dissection up to 15 months following treatment.
20 Independent t tests were performed to de termine the mean systolic blood pressure differences between groups. No significan t differences were found between the two groups (Table 3). Table 3. Independent t Test Comparison of Mean Systolic Blood Pressure Lymphedema Non-Lymphedema n Mean n Mean t p ________________________________________________________________________ Systolic #1 19 128.6 18 127.7 .16 .87 Systolic #2 19 125.4 18 126.5 .16 .87 Systolic #3 19 124.4 18 130.8 .91 .36 Mean Systolic 19 126.1 18 128.3 .41 .68 ________________________________________________________________________ Discussion Sample A limitation of the demographic data was that race was not taken into consideration. It is known that African-American women su ffer from higher rates of hypertension than women of other races ( AHA, 2004). The data collection process was complicated by the fact that vital signs were not completely documented in the charts and in some charts there was no documentation of vital signs at all. For this reason, after reviewing charts from the study population of 147 women only 19 out of the available 27 who qualified for the lymphedema group fit incl usion criteria for this study and only 18 out of the 110 of the non-lymphedema group ha d adequate documentation of vitals signs for inclusion in this study. Th e lack of documentation of vita l signs may indicate that this
21 is not an area that is scru tinized during patient visits. The assumption of white coat hypertension or problems of higher priority may have overshadowed these observations. Possibly, because of this the connection between lymphedema and elevated blood pressure is not an observation that can be ma de on a daily basis as a risk factor for lymphedema. This study is different from studies reviewed in that it relied on the presence of a diagnosis code for lymphedema to identify patients who were diagnosed as having developed lymphedema. Although it is a logical assumption that between physician documentation and physical thera py provided for lymphedema a diagnosis code would be generated; this retrosp ective method of determ ining presence of lymphedema is only as reliable as physician reports of an existence of lymphedema and may not be any more reliable for identifyi ng patients with lymphedema than patient questionnaire. Although this was a small sample of patients the two groups were very comparable in age and total number of nodes removed. This was a strength of this study. A larger sample with better representation ma y have had a different more generalizable outcome. Stages of Hypertension Among Groups Stages of hypertension were also very similar among groups. Both groups had the largest portion of patients in the Pre-HTN stage. It is estimated that among people age 18 to 74 years old, 30% are unaware they have hypertension and since the latest JCN VII guidelines were published many clinicians may not consider the new pre-HTN stage with a systolic range from 120 to 139 mmHg to be of concern during medical oncology clinic visits when taking patient anxiety into cons ideration. These two misconceptions may lead
22 to underestimating the significance of el evated blood pressure and hypertension in relation to the onset of lymphedema. Anothe r possible explanation for this finding could be that the women were taki ng antihypertensive medications A limitation of this study was that medication data were not available. Systolic Blood Pressure and Lymphedema The results show that there is no signif icant difference in systolic blood pressure between the two groups. Previous studies have indicated a relationship between hypertension and lymphedema (Bates, et al., 1994; Deo, et al., 2004; Engel, Kerr, Shlesinger-Raab, Sauer, & Holzel, 2003; Ge ller, Vecek, OÂ’Brien, & Secker-Waler, 2003; Herd-Smith, Russo, Grazia Muraca, Rosselli De l Turco, & Cardona, 2001). The lack of relationship in this study may be due to th e small sample size that was dictated by the availability of data on the variable of syst olic blood pressure. Th e two groups consisted of women between the ages of 55 and 56 year s old. This is a very narrow age group, and does not represent the spectrum of age groups in the study sample. This group is not generalizable to the study population of stage II and III breast cancer patients. The American Heart Association estima tes that among ages 55 to 64, 53.9% of women will have a problem with elevat ed blood pressure or will be taking antihypertensive medication. In this study 89% of the lymphedema groups were in the pre-HTN stage and there was one patient in Stage I and II HTN. In the non-lymphedema group 77% of the patients were in the pre-HTN group and 2 e ach had stage I and II HTN (Chobanian et al., 2003). This patient sample has a higher percent than estimated by the American Heart Association.
23 Conclusions The results show no difference in systolic blood pressures between groups however, this preliminary study had many limitati ons, such as adequate retrospective data availability. The ages of the women available for inclusion in the two groups were very similar; this was a strength of the stu dy. Further investigatio n into the hemodynamic factors as one of the modifiable risk factor for lymphedema is warranted. Recommendations for Future Research Future prospective studie s should include standardized measures for presence and severity of lymphedema, use of JNC V II stages of blood pressure, and better documentation to determine time of onset of ly mphedema so that it can be compared to the time of occurrence of elevated blood pr essure. Future prospec tive studies may help shed light on the relationship between elevated blood pressure and treatment for hypertension on the occurrence of lymphede ma after axillary lymph node dissection.
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29 Appendices A: Letter of I RB Exempt Certification June 21, 2006 Deborah M. Arvidson-Hawkins, RN College of Nursing 12011 Driver Lane Springhill, FL 34610 RE: Exempt Certification for Application for Exemption IRB#: 104758C Title: The Relationship Between Lymphe dema and Elevated Blood Pressure in Women Following Surgery for Breast Cancer MCC 14891 Dear Ms. Arvidson-Hawkins: On 06/20/2006, the Institutional Review Board (IRB) determined th at your Application for Exemption MEETS FEDERAL EXEMPTION CRITERIA Exemption 4 Existing data, documents, records, pathological specime ns, or diagnostic specimens publicly available or recorded without identifiers. It is your responsibility to ensure that this research is conducted in a manner consistent with the ethical principles outlined in th e Belmont Report and in compliance with USF IRB policies and procedures. Please note that changes to this protocol ma y disqualify it from exempt status. It is your responsibility to no tify the IRB prior to implementing any changes. The Division of Research Compliance will ho ld your exemption application for a period of five years from the date of this letter or until a Final Review Repor t is received. If you wish to continue this protocol beyond the five-year exempt certification period, you will need to submit an Exemption Certification Request form at least 30 days before this exempt certification expires. The IRB will send you a reminder notice prior to expiration of the certification; therefore, it is impor tant that you keep your contact information current. Should you complete this study prior to the end of the fi ve-year period, you must submit an Application for Final Review Please reference the above IRB protocol number in all correspondence to the IRB or the Division of Research Compliance. In addition, we have enclosed an Institutional Review Board (IRB) Quick Reference Guide providing guidelines and resources to assi st you in meeting your responsibilities when conducting human subjects research. Please read this guide carefully.