A Satisfaction Survey on Cancer Pain Management Using a Self ...

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Background: Pain is one of the most common and distressing symptoms in patients with cancer, with a high prevalence of 90%. Appropriate pain assessment is ...
JOURNAL OF PALLIATIVE MEDICINE Volume 18, Number 3, 2015 ª Mary Ann Liebert, Inc. DOI: 10.1089/jpm.2014.0021

A Satisfaction Survey on Cancer Pain Management Using a Self-Reporting Pain Assessment Tool Sung-Nam Lim, MD,1 Hye-Sook Han, MD,2 Ki-Hyeung Lee, MD,2 Sang-Cheol Lee, MD,3 JungHan Kim, MD,4 JiNa Yun, MD,5 SongGon Park, MD,6 MinJae Park, MD,7 YoonHee Choe, MD,8 Hun-Mo Ryoo, MD,9 KyungHee Lee, MD,10 DoYeun Cho, MD,11 Dae Young Zang, MD,12 and JinHo Choi, MD13

Abstract

Background: Pain is one of the most common and distressing symptoms in patients with cancer, with a high prevalence of 90%. Appropriate pain assessment is very important in managing cancer pain. Objective: The aims of this study were to (1) evaluate patient satisfaction with pain control therapy using a selfreporting pain assessment tool, (2) explore the usefulness of a self-reporting assessment tool for patients and physicians, and (3) evaluate patient perception of pain management and opioid analgesics. Methods: We enrolled a total of 587 South Korean adult cancer patients hospitalized for five days or more. Pain assessment using a self-reporting pain assessment tool was performed by patients themselves from Day 1 to Day 5. The average pain intensity on a numeric rating scale (NRS) and the frequency of breakthrough pain between Day 1 and Day 5 were recorded with a self-reporting pain assessment tool. We evaluated patient satisfaction with pain control and the usefulness of a self-reporting pain assessment tool for patients and physicians on Day 5. Results: Among the 587 enrolled patients, 551, excluding 36 patients who violated inclusion criteria, were analyzed. The pain satisfaction rate was 79.5%, and only 6.2% of assessed patients had a negative pain management index (PMI). However, symmetry analysis for pain intensity between patient and physician showed low agreement (kappa = 0.21). The patients with dissatisfaction for cancer pain control expressed negative attitudes toward using opioid analgesics and misconceptions regarding pain management. The satisfaction for using a selfreporting pain assessment tool was 79.2% in patients and 86.4% in physicians, respectively. Conclusion: The use of a self-reporting pain assessment tool as a communication instrument provides an effective foundation for evaluating pain intensity in cancer pain management. A more individualized approach to patient education about pain management may improve patient outcome. Introduction

I

n patients with cancer, the overall prevalence of clinically significant chronic pain ranges from 15% to more than 75%, depending on the type and extent of disease as well as various other factors.1 Many treatment

guidelines have been published during the past quarter of a century,2–7 and extensive clinical experience and data suggest that adherence to these guidelines yields satisfactory pain relief for most patients (see online Supplementary Materials at www.liebertpub.com/jpm).8 However, due to many barriers to effective treatment, optimal outcome is rarely

1

Department of Internal Medicine, Haeundae-Paik Hospital, College of Medicine Inje University, Busan, South Korea. Department of Internal Medicine, Chungbuk-National University Hospital, Cheungju, South Korea. Department of Internal Medicine, Soonchunhyang University College of Medicine, Cheonan, South Korea. 4 Department of Internal Medicine, Hallym University College of Medicine, Seoul, South Korea. 5 Department of Internal Medicine, Soonchunhyang University Hospital, Bucheon, South Korea. 6 Department of Internal Medicine, Chosun University Hospital, Gwangju, South Korea. 7 Department of Internal Medicine, Pusan National University Yangsan Hospital, Yangsan, South Korea. 8 Department of Internal Medicine, Dongnam Institute of Radiological & Medicine Science, Busan, South Korea. 9 Department of Internal Medicine, Daegu Catholic University Medical Center, Daegu, South Korea. 10 Department of Internal Medicine, Yeungnam University College of Medicine, Daegu, South Korea. 11 Department of Internal Medicine, College of Medicine, Konyang University, Daejeon, South Korea. 12 Department of Internal Medicine, Hallym University Kangdong Sacred Heart Hospital, Hallym University College of Medicine, Seoul, South Korea. 13 Department of Internal Medicine, Sun Medical Center, Daejeon, South Korea. Accepted July 9, 2014. 2 3

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achieved.9 A previously reported review suggested that an average of 43% of cancer patients receive inappropriate care for pain.10 One of the major barriers to effective pain management is the patients’ lack of knowledge of the basic principles of pain management, as well as their negative attitudes toward using opioid analgesics. Knowledge and attitude surveys performed in two studies examining cancer pain management in patients given medication showed that only 60% of patients had adequate knowledge of cancer pain management.11,12 Research suggests that failure to implement evidence-based therapies stems from hesitancy and lack of knowledge by the patients, health professionals, as well as the health care system.13–19 A deeper understanding of these barriers is needed to inform implementation strategies aimed at ensuring evidence-based assessment and management that will improve therapy outcomes.16 For these reasons, reliable and comprehensive pain assessment is an essential first step for ideal cancer pain management. Various pain measurement scales can be used to measure pain intensity.1,20,21 We previously evaluated the effectiveness of a selfreporting bedside pain assessment tool.22 The result showed that using a self-reporting pain board increased the reliability of the patient’s self-reported pain in the eyes of the medical staff. However, this finding was derived from a relatively small number of cases (50 patients) enrolled at a single center. In this study we investigated cancer patients’ level of satisfaction with cancer pain management. At the same time we evaluated the effectiveness of a self-reporting bedside pain assessment tool by validating the reliability of pain intensity reporting among patients and physicians. Methods Eligibility

All enrolled patients were 18 years of age or older with cancer, experienced pain due to cancer, had normal cognitive function with ability to understand the South Korean language, and were hospitalized for five days or more. Patients with an altered level of consciousness were excluded. Cancer pain was defined as pain in people with cancer not caused by treatment (e.g., postsurgical pain or chemotherapy-induced pain), injury, or another health condition. The protocol was approved by the institutional review board of each participating institution. All enrolled patients gave written informed consent. Study design

We educated patients regarding the general principles of cancer pain and pain management on the first day of study participation. To evaluate the effectiveness of a self-reporting bedside pain assessment tool, pain assessment was performed by patients themselves. They were asked to record the mean pain score using a numeric rating scale (NRS) (range from 0 to 10, 0 indicating no pain and 10 the most severe pain) from Day 1 to Day 5. Over the five days of self-assessment, a selfreporting pain board was given to each patient, and they were instructed on how to use the board to rule out input from the investigator. This self-reporting bedside pain assessment tool had movable indicators representing 0–10 on the NRS. The average pain intensity by NRS and the frequency of breakthrough pain during the whole day were recorded. We asked

LIM ET AL.

physicians several questions about the usefulness of the selfreporting pain assessment tool, and reliability of the pain score reported by that on Day 5. In addition to exploring patient-related barriers to effective treatment such as a misconception of pain management and opioid analgesics, we investigated the perception of the enrolled patients on cancer pain and opioid therapy. All patients completed a seven-item cancer pain knowledge questionnaire.22 Patient medical record review

We obtained the following data from examining patients’ medical record: demographic data, performance status, diagnosis, disease stage, current treatment, pain intensity, and analgesic doses. The analgesic strength was categorized as 0 (no analgesic), 1 (non-opioid analgesic), 2 (weak opioid), and 3 (strong opioid). Weak opioids were considered to be codeine and tramadol. The maximum dose of the weak opioids was 400 mg/day for tramadol and 360 mg/day for codeine, respectively. If a cancer patient with pain needed more than the maximum dose of weak opioids to relieve cancer pain, we switched to the strong opioids, which included morphine, oxycodone, hydromorphone, and fentanyl. Patient pain levels, based on the modified brief pain inventory, were classified as 0 (no pain), 1 (mild pain; NRS 1 to 3), 2 (moderate pain; NRS 4 to 6), and 3 (severe pain; NRS 7 to 10). The pain management index (PMI) was used to evaluate the adequacy of analgesic use. PMI values were calculated by subtracting the pain score from the analgesic score. Scores of 0 or above indicated adequate analgesia, whereas a negative score indicated inadequate analgesia. Statistical analysis

The primary endpoint was to evaluate the patients’ satisfaction with cancer pain management. We used simple random sampling to calculate the sample size. The 2006 cancer pain survey23 in South Korea showed that 42% of cancer patients were satisfied with their pain management. We hypothesized the satisfaction rate for cancer pain management to be 45% based on the selfreporting assessment tool. A sample size of 777 produced by a simple random sampling under condition of absolute precision d = 3.5% with a two-sided 95% confidence interval. Descriptive statistics of mean and standard deviation were used to evaluate cancer pain intensity and usefulness of the self-reporting pain assessment tool. The difference of satisfaction using the self-reporting assessment tool was compared between cancer patients and physicians using the chi-square test. The agreement between patient pain score and medical staff pain score was evaluated with Cohen’s kappa coefficient. Correlation analysis was performed to evaluate interrelationship of pain intensity and effectiveness of the self-reporting pain assessment tool. The Wilcoxon signed-rank test was used to compare the relationship between usefulness of the selfreporting pain assessment tool and the pain management satisfaction rate between the satisfied group and unsatisfied group. All statistical analyses were performed using statistical software SAS (SAS version 9.2; SAS Institute Inc., Cary, NC). Results Patient characteristics

Between June and July 2012, 587 cancer patients in 29 hospitals throughout South Korea were enrolled in this study;

CANCER PAIN MANAGEMENT BY PATIENT SELF-REPORTING PAIN ASSESSMENT TOOL

36 patients were not assessed due to violation of inclusion criteria: 28 patients hospitalized < 5 days, 2 patients < 18 years, and 6 patients failed to complete the survey. The demographic and disease characteristics of the remaining 551 patients are summarized in Table 1. Patients’ satisfaction with cancer pain control

Patient satisfaction rate with pain control was 79.5% after cancer pain management, reported using a self-reporting pain assessment tool. Patient cancer pain intensity on the NRS (mean – standard deviation) decreased from 3.67 – 2.29 on Day 1 to 2.82 – 1.89 on Day 4, however it increased to 3.61 – 2.23 on Day 5. The frequency of breakthrough pain recorded on the patient’s questionnaire more significantly increased from 1.69 – 2.04 on Day 1 to 3.67 – 2.29 on Day 5 (P = 0.0286), while that on the medical record decreased to 1.41 – 1.71 on Day 5. Only 34 patients (6.2%) had negative PMI. The number of patients treated with a strong opioid was 469 (85.1%) on Day 1 and 484 (87.8%) on Day 5, respectively. The mean dose of morphine used for continuous cancer pain control increased from 175.0 – 344.3 mg on Day 1 to 201.0 – 363.0 mg on Day 5. Among painkillers, strong opioids, especially transdermal fentanyl patch, were the most commonly used analgesics to

Table 1. Basic Characteristics of the Patients Number Age (years) Median (range) 60 Sex Male (%) 303 Performance status (ECOG) 0–2 474 3–4 61 Stage of disease I 8 II 37 III 76 IV 397 Unknown 6 Pain intensity at Day 1 (NRS) Mean – SD 3.67 – 2.29 None (0) 45 Mild (1–3) 217 Moderate 199 Severe 65 Analgesics consumption at Day 1 None 33 Non-opioid 7 Weak opioid 37 Strong opiod 469 Adjuvant medication 5 Current anticancer treatment Chemotherapy 253 Radiation therapy 61 Surgery 11 Immunotherapy 4 None 236

% (27–90) 55.0 83.9 16.1 1.5 7.1 14.5 75.8 1.2 8.6 41.3 37.8 12.4 6.0 1.3 6.7 85.1 0.9 48.8 11.8 2.1 0.8 45.6

ECOG, Eastern Cooperative Oncology Group; NRS, numeric rating scale; SD, standard deviation.

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control cancer pain. The total percentage of strong opioid use to treat cancer pain increased by 3.3%, while usage of weak opioid and non-opioid analgesics decreased from 22.1% on Day 1 to 11.8% on Day 5. The proportion with transdermal fentanyl patch increased from 51.7% on Day 1 to 56.6% on Day 5. This study showed that there was a difference in cancer pain intensity assessed by patients and physicians. The pain intensity recorded by patients was 3.61 – 2.23, while the pain intensity recorded by physicians was 3.12 – 1.88 (P < 0.001). The simple kappa coefficient was 0.21, showing a low degree of agreement. The difference in the NRS values reported by patients and those reported by medical staff was greater when medical staff could not trust patients’ self-reported pain. However, regardless of that, a total of 493 (89.5%) members of the medical staff answered, ‘‘I believe the cancer pain intensity expressed by the patient.’’ Subgroup analysis of patients with moderate to severe pain intensity

Two hundred sixty-four (47.9%) patients had cancer pain of NRS 4 or more at Day 1. Among these, the pain intensity was moderate in 199 (37.8%) and severe in 65 (12.4%). After pain management, cancer pain decreased from 5.54 – 1.53 on Day 1 to 3.96 – 2.17 on Day 5, and the difference was statistically significant (P < 0.0001). The gap between NRS pain scores reported by patients and the medical staff was 0.44 – 1.85, and this was confirmed by Bowker’s test for symmetry (P = 0.5290), including that pain intensity evaluated by patients and the medical staff was identical. The mean difference in NRS scores was higher in patients who answered that the self-reporting pain assessment tool (0.74 – 1.99) was useful compared to patients unsatisfied with the self-reporting pain assessment tool (0.37 – 1.67), but the difference was not statistically significant. The effectiveness of the self-reporting pain assessment tool

The effectiveness of the self-reporting pain assessment tool was assessed in both the patients and medical staff. The rate of patients and medical staff who answered that the selfreporting pain assessment tool was useful was 79.2% and 86.4%, respectively. Higher satisfaction with the self-reporting pain assessment tool was significantly associated with less severe pain (satisfied group 3.36 – 2.08 versus unsatisfied group 4.59 – 2.53, P < 0.0001), and the same association was observed among the medical staff (satisfied group 3.00 – 1.83 versus unsatisfied group 3.93 – 1.98, P = 0.0018). Patients’ perception of cancer pain and pain management

There was a difference in the perception of cancer pain and pain management according to satisfaction with cancer pain management. The percentage of patients who answered ‘‘most pain is relieved sufficiently by painkillers’’ was 70.6% in the satisfied group and 47.7% in the unsatisfied group, respectively (P < 0.0001). The unsatisfied group (56.3%) for cancer pain management worried more about opioid addiction than the satisfied group (34.5%) (P = 0.0259). The

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Table 2. Relation Between Pain Intensity and Usefulness of Self-Reporting Pain Assessment Tool in Patient and Medical Staff Patient

Satisfied group Unsatisfied group

Medical staff

N

Pain intensity (mean – SD)

P-value

N

Pain intensity (mean – SD)

P-value

433 114

3.36 – 2.08 4.59 – 2.53

< 0.0001

476 75

3.00 – 1.83 3.93 – 1.98

0.0018

SD, standard deviation.

percentages of patients who believed that pain caused by cancer can be effectively controlled by painkillers also differed significantly: 71.2% in the satisfied group and 47.3% in the unsatisfied group (P < 0.0001). The number of patients who thought that medical staff tended to underestimate their pain was greater in the unsatisfied group, and the difference between the two groups (15.7% in satisfied versus 50% in unsatisfied) was statistically significant (P < 0.0001). Discussion

Pain is one of the most frequent and distressing symptoms of cancer. Pain is present in 36%–61% of patients depending on the cancer type, disease stage, and patient setting.24–26 The optimal control of cancer pain relies on an understanding of the underlying pathophysiology and molecular mechanisms involved. For such reasons, management of cancer pain is considered to be complicated. In the previous large, prospective, cross-sectional cancer pain study conducted in South Korea between 2001 and 2006, the satisfaction rate for cancer pain management was 42%, and more than 40% of patients reported a negative PMI.23 It can be said that based on the PMI alone, more than 40% of patients are receiving inadequate pain management. Although almost half of the patients are treated inadequately in reality,27 it has been proposed that effective treatment of pain is feasible in 70%–90% of cancer paints.28 However, numerous barriers that prevent patients from receiving effective pain treatment and physicians from providing adequate pain management have been documented. The most frequently mentioned barriers for both patients and medical professionals were knowledge deficits, inadequate pain assessment, and misconceptions regarding pain. Among these barriers, we paid attention to inadequate pain assessment. We thought that adequate pain assessment might be the first step to manage cancer pain, and a self-reporting assessment board was the effective tool to evaluate appropriate

cancer pain intensity. When an appropriate assessment of cancer pain is made by using the tool, it could help more effective cancer pain management. As another concept of pain assessment, Dalal et al.29 suggested the patient personalized goal (PPG), desired level for pain relief on a 0–10 scale, with median PPG of 3. In this study, the satisfaction rate with cancer pain management was 79%. This rate is 37% higher than that reported in 2006. The pain assessment system using a self-reporting bedside pain assessment tool provided a reliable and effective means of assessing cancer pain. The percentage of patients and medical professionals who answered that ‘‘a selfreporting bedside pain assessment tool is useful’’ was 79% and 86%, respectively. Breuer et al. reported that inadequate assessment of pain and pain management was the most significant barrier to pain management.30 Generally, in clinical situations, medical professionals are not able to accurately measure cancer pain severity due to patients’ reluctance to report their pain or to give a pain score.23,31 Medical professionals, including physicians and nurses, could use more time and effort to obtain more accurate information on patients’ pain. The selfreporting pain assessment tool could allow patients to express pain severity and medical professionals to assess pain intensity more accurately. This pain measurement tool significantly reduced the gap between pain intensity reported by patients and that reported by medical professionals and increased the patient’s satisfaction with pain management. In this study, we found a difference of reported cancer pain intensity between patients and medical staff. Considering this difference, an assessment tool to accurately evaluate the patient’s pain is needed. Such a discrepancy between perception of pain between patients and physicians was also reported in a previous small group study.22 In spite of the encouraging sign of rising satisfaction level with cancer pain management (from 42% to 79%), we faced a

Table 3. Changes of Pain Intensity between Day 1 and Day 5 Mean change from Day 5

Day Day Day Day Day

5 4 3 2 1

Number

Mean – SD

Min–Max

Mean – SD

P-value

551 526 525 527 526

3.61 – 2.23 2.82 – 1.89 3.07 – 1.97 3.25 – 1.93 3.67 – 2.29

0–10 0–8 0–9 0–9 0–10

- 0.74 – 2.20 - 0.49 – 2.32 - 0.31 – 2.38 0.11 – 2.78

< 0.001 < 0.001 0.0097 0.1932

Min, minimum; Max, maximum; SD, standard deviation.

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Table 4. Number of Breakthrough Pain from Day 1 to Day 5 (Survey Day) Mean change from Day 5

Day 5 Retrospective data in medical record Data from patient’s questionnaire Day 4 Day 3 Day 2 Day 1

Number

Mean

– SD

375 526 381 383 390 387

1.41 3.67 1.56 1.63 1.71 1.69

– – – – – –

1.71 2.29 1.86 1.86 1.99 2.04

Min–Max

Mean

– SD

P-value

0–10 0–10 0–12 0–12 0–12 0–10

0.15 0.22 0.32 0.28

– – – –

0.0398 0.0059 0.0006 0.0286

1.30 1.40 1.68 2.00

Min, minimum; Max, maximum; SD, standard deviation.

few problems in this study. First, patients often impede their own treatment due to their misconceptions about analgesics and their side effects, nonadherence to treatment regimens, poor communication of their pain, and their concerns about reporting pain to health care providers. In this study, misconceptions were more prevalent in patients unsatisfied with cancer pain management compared to satisfied patients. The patient who thought that ‘‘a good patient should endure pain as much as possible’’ endured more cancer pain and did not trust medical staff and painkillers. Considering these results, patient education on pain and pain management is important for implementing effective cancer pain control. A previous study22 showed changes in perception of cancer pain and pain management after performing patient education with a self-

reporting pain assessment tool. Palliative care teams could better educate cancer patients on cancer pain and pain management. It is necessary not to deviate from recommendations for cancer pain management. Second, painkillers were given less frequently, although patients requested breakthrough pain control. The frequency of breakthrough pain in the medical record was 1.41 – 1.71 times; however, breakthrough pain on the self-reporting pain assessment by patients was 3.67 – 2.29 times. The difference in frequency of breakthrough pain between patients and the medical record was a contributing factor for inadequate pain management. Inadequate knowledge of pain management of medical professionals was one of the physician- and nurserelated barriers reported in several studies.23–27 Fife et al.28

Table 5. Perception of Cancer Pain and Opioid Analgesics as Determined by Patient Questionnaire Number of patients (n = 547) Satisfied with self-reported pain scoring tool (N = 433)

Unsatisfied with self-reported pain scoring tool (N = 114)

Absolutely No or I don’t Absolutely No or I don’t yes or yes absolutely no know yes or yes absolutely no know N (%) N (%) N (%) N (%) N (%) N (%) Q1. Perception of pain and narcotic analgesic 1. A good patient should endure 113 (26.2) pain as much as possible 2. Most pain is relieved sufficiently 294 (68.4) by painkillers 3. The use of a painkiller can easily 195 (45.2) result in addiction 4. It is easier to endure pain than to 72 (16.9) endure the side effects of painkillers 5. Painkillers should be saved for 201 (46.6) severe pain 6. I wish to be free from pain 388 (90.0) regardless of cure 7. Medical staff tend to 84 (19.5) underestimate my pain 8. I think it is better to have less 315 (73.4) pain than to live longer 9. Pain caused by cancer can be 306 (70.8) controlled effectively by painkillers 390 (90.3) 10. I want to talk to medical staff about my pain in detail

P-value

304 (70.5)

14 (3.3)

45 (40.2)

61 (54.5)

6 (5.4)

0.0054

117 (27.2)

19 (4.4)

65 (57.5)

43 (38.1)

5 (4.4)

0.0756

187 (43.4)

49 (11.4) 56 (50.0)

42 (37.5)

14 (12.5)

0.5316

334 (78.2)

21 (4.9)

27 (24.1)

70 (62.5)

15 (13.4)

0.0006

224 (52.0)

6 (1.4)

47 (42.0)

61 (54.5)

4 (3.6)

0.2438

36 (8.4)

7 (1.6)

95 (84.1)

13 (11.5)

5 (4.4)

0.1039

311 (72.3)

35 (8.1)

40 (35.7)

59 (52.7)

13 (11.6)

0.0003

84 (19.6)

30 (7.0)

75 (67.0)

25 (22.3)

12 (10.7)

0.2967

64 (14.8)

62 (14.4) 61 (54.0)

41 (36.3)

11 (9.7)

< 0.0001

31 (7.2)

11 (2.6) 101 (89.4)

10 (8.9)

2 (1.8)

0.7528

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showed that the majority of physicians and nurses believed that patient requests for increased doses of analgesics were a result of drug tolerance, as opposed to increased pain. In this study, 36% of physicians and 41% of nurses reported that analgesics use should be limited based on the patient’s prognosis. Because of these misconceptions for cancer pain management, it is difficult to adequately treat cancer pain. Physicians32 and nurses33 often create barriers to effective pain management. There are some limitations in this study. First, the sample size was insufficient. The number of patients initially planned was 777, but we enrolled only 587 patients. Cancer pain management satisfaction increased from 42% to 79% compared to the previous result, although this study did not have enough power to confirm the result. Second, in this study we failed to show a significant decrease in pain intensity after using the self-reporting pain assessment tool. The pain intensity described by patients decreased gradually between Day 1 and Day 4; however, on Day 5 it increased to the same level as the baseline pain score. Considering the decrease of pain intensity among the patients with NRS 4 or more, the increased pain score in Day 5 was attributed to the increase of pain score in patients with lower pain scores in Day 1. In addition, the frequency of breakthrough pain increased from 1.56 on Day 4 to 3.67 on Day 5. Due to greater breakthrough pain in patients with mild cancer pain, the pain score on Day 5 assessed by patients might have increased compared to that of Day 4. Although the patient’s pain increased, pain management was performed appropriately using the self-reporting pain assessment tool. The use of a self-reporting pain assessment tool for facilitating communication between patients and medical professionals provides an effective foundation for removing the barrier to appropriate cancer pain management. Lack of formal assessment procedures is a major barrier to effective cancer pain management in patients and health care providers. The self-reporting pain assessment tool is a reliable instrument for evaluating cancer pain intensity and improving communication between patients and physicians. In addition, in agreement with the results of previous studies, this study also confirmed that one of the major barriers to effective pain management is the patient’s lack of knowledge of the basic principles of pain management, as well as their negative attitudes toward using opioid analgesics. Individualized and continuous approach to patient education about cancer pain management is necessary to eliminate misconceptions about the use and effects of drugs commonly used to treat cancer pain. It may help to reduce treatment duration and improve patient outcomes. Acknowledgments

In addition to the authors listed in the manuscript, the following investigators participated in the study: Drs. WanGu Uh (Kyung Hee University Hospital at Gangdong), GeunDoo Jang (Hallym University Medical Center), Dong-Hoi Goo (Kangbuk Samsung Hospital), So-Yeung Yoon (Konkuk University Medical Center), Hoon-Gu Kim (Gyeongsang National University Hospital), Yoong-Yeung Jo (Dongguk University Medical Center), Yoon-Sun Choi (South Korea University Guro Hospital), Do-Heung Im (Dankook University Hospital), So-Yeung Jung (Bundang Cha Medical

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Center), Min-Seung Kim (Sam Hospital), So-Yeon Oh (Seoul Medical Center), Keung-Eun Lee (Ewha Woman’s University Mokdong Hospital), Heung-Kyeu Lee (Inha University Hospital), Joon-Cheul Lee (Presbyterian Medical Center), In-Kyeu Hwang (Chung-Ang University Hospital), Duk-Seung Shon (The Cheongju St. Mary’s Hospital), and Heun-Sik Jung (Sunlin Hospital Handong University). Author Disclosure Statement

The authors declare no conflicts of interest. The study was supported by Janssen Pharmaceuticals Inc., whose role was restricted to providing assistance to the investigators in data collection and analysis. References

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Address correspondence to: Hye-Suk Han, MD Chungbuk National University Hospital Department of Internal Medicine 766, 1 Sunhwan-ro, Seowon-gu Cheongju, South Korea 362-711 E-mail: [email protected]