Pii: s0885-3924(02)00598-5

Journal of Pain and Symptom Management Original Article
Rama Sapir, BScPharm, M Med Sci, Michael Patlas, MD, Shalom David Strano, MD, Irit Hadas-Halpern, MD, and Nathan I. Cherny, MB BS, FRACPDepartment of Medical Oncology (R.S., N.C.) and Department of Radiology (M.P., I.H.-H.),Shaare Zedek Medical Center; and HALA: The Rachel Nash Jerusalem Comprehensive Breast Clinic (S.D.S), Jerusalem, Israel Abstract
The documented incidence of pain associated with screening mammography varies from 1% to
62%. Some researchers suggest that pain may undermine compliance with screening
mammography. As a part of a quality improvement project, we have surveyed women
undergoing mammography in 2 centers in Jerusalem to identify the prevalence, severity, and
duration of mammography-associated pain, demographic risk factors, and the degree that this
may undermine compliance with breast cancer screening. A 23-item questionnaire was
administered to 399 women (32% at the Shaare Zedek Medical Center [SZMC] and 68% at
the Rachel Nash Comprehensive Breast Clinic [HALA]). Of the total, 77% of the women
reported that the procedure was painful. Of those reporting pain, 60% described pain intensity
as moderate or severe. In 67%, the pain resolved within 10 minutes. By univariate analysis,
the only significant predictor for pain during mammography was cyclic breast pain (
P ϭ
0.053). No significant correlation was identified for age, breast size, pre-mammography
counseling, and examination center (SZMC vs. HALA). The prevalence of pre-mammography
counseling or explanation was low (51%). Despite that, 61% of the respondents expected that
mammography would be painful. Indeed, most of those who anticipated pain reported that the
actual severity was not greater than the anticipated severity. Even among women who reported
pain of moderate or greater severity, less than 5% expressed preference to receive pre-emptive
analgesia prior to their next mammogram. A substantial minority of women acknowledged that
the experience of their mammography invoked reactions that may impend future compliance;
26% reported anxiety and 12% reported pain as factors that may interfere with ongoing
compliance with regular mammographic screening. These data serve to emphasize the need for
appropriate pre-test counseling and suggest a possible role for post-test debriefing to address those
factors which may interfere with future test compliance.

53–63. 2003 U.S. Cancer Pain Relief Committee. Published by Elsevier. All rights reserved. Key Words
Mammography, pain, discomfort

Breast cancer is the most common cancer in women and the leading cause of cancer related Address reprint requests to: Nathan I. Cherny, MBBS, FRACP, Director, Cancer Pain and Palliative Medi-cine, Department of Medical Oncology, Shaare Zedek Medical Center, Jerusalem, Israel 91031.
among women and the incidence rate is higher Accepted for publication: March 8, 2002. than in most European countries, but lower 2003 U.S. Cancer Pain Relief Committee Published by Elsevier. All rights reserved.
than in the US.2 Early detection of breast can- To date, controversy continues to cloud the cer is a major public health priority.
issue of mammography-associated pain. There remains no consensus as to the prevalence of most effective method for the early detection the problem, its severity, its duration, risk fac- of breast cancer. In most published studies, it tors for the development of pain, or the impact had been demonstrated that screening mam- on future compliance. We have attempted to ad- mography can significantly reduce mortality at- dress these issues in a survey of women undergo- ing mammography in 2 centers in Jerusalem.
older than 50 years of age.3–8 The efficacy ofthis approach remains controversial, however,and a recent study demonstrated that the addi- Methods
tion of annual mammographic screening to a at the Department of Radiology at the Shaare Zedek Medical Center (SZMC) and the Rachel 50–59 years.9 In particular, public health policy Nash Comprehensive Breast Clinic (HALA) in regarding mass screening with mammography Jerusalem during December 2000 and January for women younger than 50 remains controver- 2001 were asked to participate in a prospective sial, as the data for women of this age group is study of pain related to mammography. The participants were given a brief explanation on the survey by the mammography technician.
from community-based mammography programs, The survey questionnaire was administered to it is essential that eligible women in the commu- women after the procedure was completed, while nity attend initial baseline mammograms and waiting to be discharged. Completed question- annual or biennial re-screening mammography naires were referred to the radiologist who in- at least until age 70.1 Surveys evaluating the rate dicated the reason for performing the test: of adherence to mammographic screening in western countries show that in countries with so- were carried out using standard institutional cial health systems the rate of performance of procedures. At neither center was the level of then 50 is 70–90%.10,11 In the US, 33–63% of The survey tool was a structured self-com- women over the age of 40 had undergone at pleted 23-item questionnaire. It recorded pa- tient demographics, and evaluation of patient’s In Israel, mammographic screening for early experience with regards to physical pain, pre- detection of breast cancer among women over mammogram counseling, and general satisfac- 50 years of age is included in the basket of ser- tion. Pain severity was assessed using a 5-point vices provided under the Israeli National verbal descriptive scale. The questionnaire was Health Insurance Law since 1995.13 Despite this, compliance with screening mammogra- Response frequencies for each of the demo- phy is relatively low.14 Bentur et al., from the graphic, pain descriptive, and analytical items JDC-Brookdale Institute of Gerontology and were analyzed by actual percentage responses to each of the multiple-choice options. The in- that only 56% of women between the ages 50– fluence of site of examination on patient atti- 74 underwent at least one mammographic ex- tudes and preferences was evaluated by chi- amination during their lives and only 49% of them had undergone a test in the past 2 years.
It is important to identify barriers to compli- ance with screening mammography. Some re- Results
searchers suggest that pain associated with the A total of 399 women completed the survey, compliance with screening mammography.15–17 128 (32%) at SZMC and 272 (68%) at HALA.
It had been suggested that a painful mammog- A total of 84% of women were referred for and discourage the participation of peers.
nostic investigation of suspicious lesions. The major reason for not completing the survey questionnaire was language barrier. The ma- By univariate analysis, the only predictor for jority of women completed the questionnaire within 5 minutes of finishing the mammogram significance was the prior existence of cyclic (73%) and the rest within 5–10 minutes (25%).
breast pain (P ϭ 0.053). No significant correla- The demographic characteristics of women from tion was identified for age, breast size, pre- both centers were similar and are presented in Table 1. Twenty percent of women reported breast tenderness prior to the mammography;15% reported mild tenderness, and 5% reported moderate or greater severity, fewer than 5% expressed a preference to receive pre-emptive Seventy-seven percent of the women reported analgesia prior to their next mammogram. A that the procedure was painful. Of those re- substantial minority of women acknowledged porting pain, 31% described pain intensity as that the experience of their mammography in- moderate, and 34% described pain as severe.
voked reactions that may impede future com- In 67% of respondents, the pain resolved within pliance; 26% reported anxiety regarding the 10 minutes. The majority of women reported test and its outcome and 12% reported pain as pain as symmetric (Ͼ60%). The expectation of factors that may interfere with ongoing compli- ance with regular mammographic screening.
would be painful matched the actual pain.
Only half of the respondents reported that In prior studies, predictors of adherence with they received any explanation regarding the screening mammography have included demo- mammography they were to undergo. Of those graphic factors: younger age, higher level of in- who received prior counseling, 66% were told come, ownership of health insurance, higher that the procedure would be painful.
level of education, and Caucasian ethnicity.
Patient Demographics
Documented barriers to compliance include invalid.40 In the current study, the 5-point ver- women’s beliefs and attitudes with respect to bal rating scale was selected because it is a vali- screening mammography, a family history of dated scale and was appropriate for a large breast cancer and prior mammography experi- study of a heterogeneous population of women ence associated with embarrassment and un- involving a self-administrated questionnaire.41 pleasant interactions with the screening staff.18–24 The current study adds to the evolving pic- There are a few published studies addressing ture of mammography-related pain. Pain is com- the issue of barriers to compliance with screen- mon and it is reported by up to 77% of women.
ing mammography that relate to health behav- Pain is usually mild to moderate in severity iors in Israeli women.25–27 None of these stud- (66%), and is severe in about a one-third of ies addressed the issue of pain associated with women. The frequency of pain in this study is similar to that reported by previous researcherswho used a validated pain measure.19,20,30,34 Frequency and Degree of Reported Pain There is wide discrepancy in the reported rate of mammography-associated pain. The re- In studies to date, there has been no consis- ported incidence ranges from 1% in Stomper tency in the timing of pain assessment with re- et al.28 to 85% in the study conducted by Korn- lation to the mammogram. In some studies, guth et al.29,30 The documented incidence of pain assessment took place immediately after pain associated with screening mammography mammography, whereas in others women were varies from 1% to 62%.21,28,30–34 Methodologi- asked to provide retrospective assessment, hours cal problems appear to contribute to the varia- or days after mammography. Keefe et al. sug- tion in results. There is clear lack of consis- gest that time may play a significant role in bi- tency relating to the use of pain scales in these ases associated with retrospective reports of pain.40 In the current study, pain assessment In the studies summarized in Table 2, the was performed soon after examination. In this pain assessment instruments varied from a sim- way, the actual experience of pain was assessed ple 4-point verbal rating scale to the use of in real time rather than a recall of the event. By multiple assessment measures including Visual administrating the survey questionnaire soon Analog Scale, the Brief Pain Inventory, and the after the examination, we were also able to as- McGill Pain Questionnaire.35,36 Several studies sess the duration of mammography associated used an idiosyncratic univariate 6-point scale pain. This is important information that is not that sought to evaluate both discomfort and provided by many of the previous studies. Our pain, and in some studies, the pain assessment data confirm that pain caused by mammogra- instrument is not described at all.28,37–39 phy is an acute, transient, self-limiting pain In an analysis of these data, Kornguth et al.
that usually resolves within 10 minutes. Similar found that when well validated measured of findings were reported by Rutter et al.42 pain like the Visual Analog Scale (VAS) or theMcGill pain questionnaire (MPQ) are used, a Predictors and Risk Factors for Pain large proportion of women report having pain Demographic and technical factors predic- during mammography.30 The results of their tive of worse pain with mammography are com- study strongly suggest that the method used to plex and the data are characterized by many report pain can influence the proportion of contradictory findings (Table 3). In the cur- women reporting pain. In studies using unidi- rent study, the only significant predictor of mensional 6-point pain/discomfort scale, a pain was breast tenderness. This is consistent with the findings of a number of other re- found.30 The 6-point unidimensional scale in- corporates unpleasantness and the perceived Facility-specific features and staff attitude sensory intensity in a single item question. This may be a risk factor for pain prevalence. Dul- scale allows a limited set of response options regarding pain and it may not be sensitive enced pain in certain mammography centers enough to measure the incidence of pain. In- than others and that a belief that the technolo- deed, Keefe et al. suggest that this approach is gist was too rough was a significant predictor of Summary of Studies Examining Pain and Discomfort During Mammography, 1988–2001
magnitudeof painassociated withmammography expectationson theexperience ofpain duringmammography influencingattendancenon-attendanceandre-attendanceat a breast-screeningcenter Continued
discomfortexperiencedwas perceivedas a deterrentfor re-screening wouldprevent herfrom having afurthermammogram womenhaving a firstmammogramstatedthat theirmammogramexperienceaffected theirfuture plansfor havinganother.
experience and the sensationexperience inwomenundergoingmammography discomfort withsociodemo-graphics, personal history,psychologicalfactors Continued
quality andintensity ofmammography pain using avariety of painmeasures degree ofdiscomfortexperienced bywomenattending forfirst-timemammography Of 200 women who had received and declined an invitation for re-screening (n ϭ 81), the major reason (46%) was their previous mammogram being painful.
who have beenscreened oncein a breastscreeningprogrammeddecline aninvitation forfurtherscreening pain.43 In our study, no difference in pain fre- component of a successful mammogram exam- ination. Compression is necessary to separate overlapping structures, to improve detection accurately and to reduce the amount of radia- compression of the breast, which is a crucial tion absorbed by the breast tissue. There is no Continued
factors thatdetermine therisk of a painfulexperience associationswith personaland medicalhistory,sociodemo-graphics and/or situationalfactors of pain onintention toreturn forfuture breastcancerscreening N ϭ not indicated; VAS ϭ Visual Analog Scale; BPI ϭ Brief Pain Inventory; McGill ϭ The McGill Pain Questionnaire; STAI ϭ State-Trait and Anx- quantitative guideline to indicate the optimum pression and pain were inconclusive. With re- amount of force to use37,44 The suggested ac- gards to the image quality, the majority of tual amount of appropriate pressure force radiologists involved in this study perceived needed to obtain film quality and reduced ra- that the lower-compression view does not di- diation is probably in the range of 25–40 lbs.21 minish image quality. Their results suggest that Only 3 studies have addressed the issue of cor- the experience of discomfort in mammogra- relation between level of compression and phy may not be simply due to the level of pain during mammography. In 2 studies, Sulli- van et al.37,44 and Kimme-Smith et al.,45 a rela- other variables that interact with this variable.46 tionship between compression and pain sever-ity was observed. However, the results of the Intervention Strategies to Prevent/Manage Pain study reported by Poulus and Rickard46 regard- Strategies to address the issue of compres- ing the correlation between the level of com- Risk Factors Associated or Not Associated with Pain During Mammography
Underlying breast disease (usually fibrocystic disease) mography have been investigated by other re- mammography. The Kornguth et al. study re- searchers. Kornguth et al. tested the hypothesis ports that a total of 22% of women had taken that giving women control over the compres- either pain medication or a tranquilizer on the day of mammography.30 This study found that tion results in the perception of less painful ex- the use of medication did not appear to influ- ence pain rating. In the current study, only 3% The results of the study supported the hy- of the participants responded positively to the pothesis. Patient-controlled compression resulted question regarding their desire to receive a in less painful experience without detracting painkiller prior to their next mammography.
from the quality of the image produced.
The currently available data regarding the is- Nielsen et al. suggested that patient educa- sue of pre-emptive analgesia for mammography- tion by trained nursing counselors may reduce associated pain is not sufficient to indicate the mammography-related pain and discomfort.47 value of pre-medication as a preventive measure.
Another strategy to reduce pain associated withbreast cancer screening has been the develop-ment of new imaging techniques that do not Conclusions
require breast compression. At a recent confer- The results of this study add to the evidence ence of the Radiology Society of North Amer- ica, Rosenthal et al. reported a study evaluating with a transient pain experience of moderate Diffraction Enhanced Imaging (DEI) as an al- severity. Our data confirm that pain caused by ternative to standard mammography with im- mammography is acute, short-lasting pain that proved patient comfort and enhanced diagnos- resolves in most cases within not more than 10 tic performance.48 The authors of this study minutes. In our study, the only significant pre- conclude that DEI may allow breast imaging dictor of pain was breast tenderness. Despite without breast compression, but these are pre- the frequency of pain experienced by the re- liminary results of a small study performed on spondents, a substantial minority of women ac- human specimens and further research on this knowledged that the pain experience during their mammography invoked reactions that may In recent years, attention has been focused on procedural pain and its pharmacological collected in this study serve to emphasize the prevention. There is only one published study need for appropriate pre-test counseling and that evaluated medication intake on the day of suggest a possible role for post-test debriefing to address those factors which may interfere Screening Study. A questionnaire survey. Cancer 1990; 18. Thomas LR, Fox SA, Leake BG, et al. The effectsof health beliefs on screening mammography utili-zation among a diverse sample of older women.
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161l - answer and counterclaim

Case 3:05-cv-05553-GEB-TJB Document 3 Filed 01/30/2006 Page 1 of 22Robert G. Shepherd, Esq. (RGS-5946) Brooks R. Bruneau, Esq. (BRB-5523) MATHEWS, SHEPHERD, MCKAY & BRUNEAU, P.A. 100 Thanet Circle, Suite 306 Princeton, NJ 08540-3674 Telephone (609) 924-8555 Facsimile (609) 924-3036 Attorneys for Defendants and Counterclaimants, RANBAXY PHARMACEUTICALS, INC., RANBAXY INC. AND RANBA


Before the Federal Communications Commission Washington, D.C. 20554 Amendment of the Commission’s Rules with Regard to Commercial Operations in the 3550- ) REPLY COMMENTS OF EXELON CORPORATION Exelon Corporation (“Exelon”) hereby submits its Reply Comments in the above-referenced Docket.The Exelon companies – ComEd, PECO Energy, and Baltimore Gas and Electric (“BGE”

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