Japanese Journal of Clinical Oncology 34:37-42 (2004)
© 2004 Foundation for Promotion of Cancer Research
Adequacy of Cancer Pain Management in a Japanese Cancer Hospital
1 Department of Symptom Research, Division of Anesthesiology and Critical Care, University of Texas M. D. Anderson Cancer Center, Houston, TX, USA, 2 Psycho-Oncology Division and 3 Psychiatry Division, National Cancer Center Research Institute East, Kashiwa, Chiba, Japan, 4 Course of Specialized Clinical Care, Psychiatry, Tokai University School of Medicine, Isehara, Kanagawa, Japan
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ABSTRACT |
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 TOP ABSTRACT INTRODUCTIONPATIENTS AND METHODSRESULTSDISCUSSIONAcknowledgmentsREFERENCES |
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Background: Pain is one of the most frequent and deleterious symptoms in cancer patients. This study was carried out to investigate the adequacy of pain management at the National Cancer Center Hospital East, Japan.
Methods: The available data were obtained from 138 ambulatory cancer patients with pain. The data included pain severity, which patients reported using the Japanese version of the M. D. Anderson Symptom Inventory, along with such medical information as cancer and treatment information and currently prescribed analgesics. Adequacy of pain management was assessed using the Pain Management Index, which revealed whether prescribed analgesic drugs were congruent with pain severity.
Results: Physicians undertreated pain in 70% of patients. Patients with non-advanced cancer (local cancer or no evidence of any recurrent cancer) were more likely to receive inadequate treatment than those with advanced cancer [P = 0.009, odds ratio = 0.18, Exp (95% CI) lower = 0.05, higher = 0.64] in the exploratory logistic regression analysis. Additionally, we found significant differences among physicians in ability to manage cancer pain, unrelated to a physician’s years of experience as an oncologist.
Conclusions: This study suggests that cancer pain management is insufficient at the investigated institute. Remedial action should be taken, including increasing awareness of symptom management in medical staff and incorporating existing knowledge into routine clinical practice.
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INTRODUCTION |
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TOPABSTRACTINTRODUCTIONPATIENTS AND METHODSRESULTSDISCUSSIONAcknowledgmentsREFERENCES |
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Despite significant advances in past decades, cancer remains the primary cause of death in Japan. About 300 000 people die from cancer every year, representing a third of total deaths in Japan (1). Throughout their clinical course, cancer patients frequently suffer from a variety of symptoms, such as pain, dyspnea and fatigue (2,3), that impair their bodily functions and quality of life. Palliation of these symptoms has been recognized as crucial to improving the quality of life for cancer patients (4).
Pain remains one of the most common and deleterious symptoms suffered by cancer patients and is the critical theme in current cancer medicine (5). The Pain Management Index (PMI) is a well-validated method of assessing the adequacy of pain management. Developed by Cleeland (6), the PMI is based on cancer pain treatment guidelines established by the World Health Organization (7) and the Agency for Health Care Policy Research (8). Pain management is considered adequate when there is congruence between the patient’s reported level of pain and the appropriateness of the prescribed analgesic drug. The PMI provides a comparison of the most potent analgesics prescribed for a patient’s reported pain (detailed calculation method is described in the ‘Statistical method’ section). The PMI has been widely used and enables researchers to compare the adequacy of pain across countries, races and institutes (Table 1) (9–18).
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Few studies, however, have investigated the adequacy of cancer pain treatment in Japan. Uki et al. investigated cancer pain treatment at the Saitama Cancer Center in Japan and found that only 27% of cancer patients in their study had a negative PMI (9). This proportion was the lowest among PMI studies conducted in many countries, indicating that adequate cancer pain management was practiced in Saitama Cancer Center. However, these results may not be indicative of the status of cancer pain management in Japan as a whole. One suggestive indicator of poor pain management in Japan is the small amount of morphine consumed in Japan [3438 daily defined doses (DDD) per million inhabitants per day during 1994–1998, ranking 30th worldwide], which is only 18% of the amount consumed in the USA (20 585 DDD, ranking 7th worldwide) (19).
In the present study, we applied the PMI to investigate the adequacy of pain management at Japan’s National Cancer Center Hospital East. We also investigated the characteristics of patients at greater risk for under-medication with analgesic drugs. Furthermore, we examined whether there were differences among physicians in ability to manage cancer pain.
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PATIENTS AND METHODS |
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TOPABSTRACTINTRODUCTIONPATIENTS AND METHODSRESULTSDISCUSSIONAcknowledgmentsREFERENCES |
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In this study, we employed an existing database which has been developed to study fatigue. The subjects of this database were randomly selected cancer patients receiving treatment at the outpatient clinics of the National Cancer Center Hospital East, Japan. To be eligible, the patients: (i) had to have a pathological diagnosis of cancer, (ii) must have been informed of their cancer diagnosis, (iii) had to be able to understand and complete the questionnaires and (iv) could not be suffering from severe mental or cognitive disorders. Data from patients with pain [defined as patients who reported pain as 1 or greater on the pain item of the Japanese-language version of the M. D. Anderson Symptom Inventory (MDASI-J, described below)], were extracted from this database.
The study was approved by the Institutional Review Boards of the National Cancer Center, Japan. Written consent was given by each patient after being fully informed of the study.
Patient-reported Pain Severity
The subjects in the study were given the MDASI-J as their self-reporting instrument, with one pain item on this scale used as a pain measure. This questionnaire, developed by Cleeland et al., consists of 13 symptom items and six interference items with 0-to-10 numeric scale ratings (20). The symptom items asked the patient to identify the worst level of each symptom in the last 24 hours, with anchor points of 0 (not at all) to 10 (as bad as you can imagine). The validity and reliability of the MDASI-J is well established (21).
Analgesic Prescription and Other Medical Information
Information on prescribed analgesic drugs, cancer type and history of anticancer treatment were obtained from the patients’ medical records and from an electrical clinical management database, using a specific checklist.
Attending physicians were asked to determine the patient’s performance status as defined by the Eastern Cooperative Oncology Group (ECOG).
Statistical Methods
The PMI was calculated as follows. The most potent analgesic prescribed was classified at one of four levels: 0 = no analgesics, 1 = nonopioid analgesics, 2 = weak opioid, 3 = strong opioid. Patients’ self-reports of pain on the MDASI-J were classified into three groups based on how pain interferes with function (22): 0 = no pain, 1 = mild pain (1–4); 2 = moderate pain (5–6); and 3 = severe pain (7–10). The PMI, calculated by subtracting the pain level from the analgesic level, can thus range from –3 to 3, with the lower value representing greater undertreatment. Negative PMI scores are considered to be an indicator of underestimation regarding analgesics, and scores of 0 or more are considered to be very conservative indicators of acceptable treatment. The PMI does not account for dosage of analgesics, schedule, patients’ compliance or adjuvant pain medication.
Logistic regression analysis was used to clarify factors correlated with the PMI. The PMI was dichotomized as 1 (negative PMI or undertreatment of pain) or 0 (0 or greater PMI) and entered as a dependent variable. We performed regression analyses in two stages. First, we conducted confirmatory regression analysis to examine whether previously identified risk factors associated with pain undertreatment would hold in this sample. Second, we did an exploratory analysis to investigate factors associated with inadequate pain management, while controlling for the effect of the risk factors we identified in the first stage of the analysis.
Previous studies reported that gender (female) (9–11), age [older (11), younger (14)], education (low) (16), physical condition [better ECOG performance status (11,13,14), without metastasis (14)], race (minority) (11), discrepancy between patient and physician estimates of pain severity (greater) (9–11,14), patient reluctance to report pain (10) and lack of staff time (10) are significant predictors of inadequate cancer pain treatment. However, data collected for this study only included the first five variables. In the second stage, univariate analyses were used to screen possible correlates of the PMI. A predictor was considered a candidate if it had a marginal association (P 
0.25). The retained predictors and those extracted in the first step were gathered and entered into a multiple logistic regression analysis with stepwise selection.
Additionally, we investigated individual variation in PMI by physician. First we conducted the Fisher exact test to examine the relationship between patients having positive PMI and their physicians. Second, we calculated Pearson correlations to investigate whether an individual physician’s years of experience as an oncologist was correlated with the average PMI value for his or her patients.
All statistical tests were two-tailed. All statistical procedures were performed using SPSS 10.0 for Windows statistical software (SPSS Institute Inc., 1999).
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RESULTS |
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TOPABSTRACTINTRODUCTIONPATIENTS AND METHODSRESULTSDISCUSSIONAcknowledgmentsREFERENCES |
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Participant Characteristics
Patient sampling was conducted at the outpatient clinics of six oncology divisions (palliative care, thoracic oncology, gastrointestinal oncology, head and neck oncology, hepatobiliary and pancreatic oncology and chemotherapeutic oncology). A potential pool of 282 outpatients was identified for the study. The available data was obtained from 138 patients, whose sociodemographic and clinical characteristics are shown in Table 2. Male participants accounted for 58% of the sample; the mean age was 62.6 years (range 21–84 years, SD ± 11.3). The most frequent cancer sites were lung (24%), gastrointestinal (21%) and liver (13%). Twenty-four percent of patients were in severe condition, with an ECOG performance status score of 2 or more. Of the 144 patients who were excluded from the study, 19 (7% of identified patients) were ineligible for the following reasons: eight for cognitive disturbance, seven for illness and four for other reasons. Eight patients (3%) refused to participate and two (1%) were not able to complete the questionnaires. We were unable to contact one patient (<1%). One hundred and fourteen patients (40%) were excluded because of lack of pain.
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Patients were seen by a total of 18 oncologists, all of whom were male. The mean of the oncologists’ years of experience was 10.0 years (SD = 4.9, median = 8 years).
Pain severity in This Population
Using a previously validated pain severity classification (6), 22% of patients reported severe pain (7 or greater) on the MDASI-J, 19% reported moderate pain (5–6) and 59% reported mild pain (1–4).
Inadequacy of Analgesic Drug Therapy: the Negative PMI
Forty-one percent of the patients were prescribed analgesics. Eighteen percent were receiving opioid analgesic treatment: 14% were taking strong opioids and 4% were taking weak ones. Table 3 shows the association between pain intensity and prescribed analgesics. The proportion of patients with negative PMI was 70.3%, which indicated undertreatment of pain and less-than-adequate analgesics based on WHO guidelines.
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Factors Associated with a Negative PMI
The results of a confirmatory analysis showed that patients with better ECOG performance status scores and those without metastasis were undertreated more frequently than other patients in the study (Table 4). An exploratory univariate analysis of disease phase, job status and marital status revealed that disease phase and job status were significant factors. Since the concepts of metastasis and disease phase were similar and correlated significantly (P < 0.001, chi-squared test), metastasis was excluded from the final model. Thus, three variables (performance status, job status and disease phase) were entered in the final logistic regression analysis as independent variables. Results showed that disease phase was the only factor significantly associated with inadequate pain management, indicating that patients with non-advanced cancer (local cancer or no evidence of any recurrent cancer) were more likely to receive inadequate treatment than those with advanced cancer [P = 0.01, odds ratio = 0.18, Exp (95% CI) lower = 0.05, higher = 0.64] (Table 5).
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Difference in Ability of the Cancer Pain Management by Physicians
We found a significant difference in the proportion of patients having positive PMI by physician (P < 0.001, Fisher exact test). We did not find a significant correlation between years of experience as an oncologist and the average PMI by physician (r = –0.06, P = 0.83, Pearson correlation).
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DISCUSSION |
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TOPABSTRACTINTRODUCTIONPATIENTS AND METHODSRESULTSDISCUSSIONAcknowledgmentsREFERENCES |
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Pain is one of the most frequent and distressing symptoms experienced by cancer patients and affects their quality of life. Few studies have examined the adequacy of cancer pain management in Japan, either generally or at single institutes, since Dr Uki’s report in 1998 (9). Nonetheless, accumulating data regarding the adequacy of cancer pain management is crucial to improve symptom management. We believe this study will underscore the importance of cancer pain management and promote a nationwide study to investigate the true status of cancer pain management in Japan.
We found that 70% of ambulatory cancer patients with pain at the investigated institute received inadequate treatment for their pain. This rate was almost twice that reported by Uki (9) for the Saitama Cancer Center, Japan. Dr Takeda, the former president of the Saitama Cancer Center, was pioneering cancer pain management in Japan as early as the 1980s. Under his leadership, the Saitama Cancer Center has provided excellent pain management as a WHO Collaborating Center Cancer for Pain Relief and Quality of Life in Japan. Dr Takeda provided his staff with pain management manuals from the WHO, from a medical association and from the Ministry of Health and Welfare (currently the Ministry of Health, Labor and Welfare). He also vigorously gave in-hospital lectures and seminars promoted by the WHO, the Ministry of Health and Welfare and the Institute itself (personal communication with Dr Uki, Saitama Cancer Center). In comparison, few specific institutional efforts have been made to improve cancer pain management at the National Cancer Center Hospital East. This disparity in institutional effort may explain the difference in the quality of the pain management between these two hospitals.
Various health care system barriers, including the low priority given to cancer pain management, have been reported (8,23,24). The Joint Commission on Accreditation of Healthcare Organizations, an independent non-profit organization established to improve the safety and quality of medical care through the provision of health care accreditation and related services in the USA, developed a standard in 2001 that established new requirements for the assessment and management of pain in accredited hospitals and other healthcare settings (25). Key concepts include: (i) recognize the patient’s right to appropriate assessment and management of pain; (ii) assess the nature and intensity of pain in all patients; (iii) record the results of the assessment in a way that facilitates regular reassessment and follow-up; (iv) determine and ensure staff competency in pain assessment and management, and address pain assessment and management in new-staff orientation; (v) establish policies and procedures that support the appropriate prescription or ordering of effective pain medications; (vi) educate patients and their families about the importance of effective pain management; (vii) address patient needs for symptom management in the discharge planning process; and (viii) collect data to monitor the appropriateness and effectiveness of pain management. All healthcare institutes must address this standard to provide better pain management.
Pain should be actively treated even when the patient’s physical condition seems to be good and even when it is mild, since our previous study showed that pain rated as low as 2 on a 0-to-10-point numerical scale was severe enough to interfere with daily life activities (26). However, when we performed confirmatory analysis of better performance status and the absence of metastasis and exploratory analysis of non-advanced disease stages, our results indicated that patients in better condition were more likely to be inadequately treated, consistent with the previous pain studies (11,13,14). Unfortunately, we did not have information on physicians’ assessments of patients’ pain severity because we were using an existing data set. Nonetheless, previous studies have indicated that discrepancy in the assessment of pain severity between patients and physicians is a strong predictor of inadequate pain management (9–11,14). Inclusion of this factor in future studies would strengthen the findings.
Interestingly, we found differences among individual physicians in their ability to manage cancer pain, regardless of their years of oncology experience. We know of few studies that have investigated the characteristics of physicians who have difficulty controlling cancer pain. Such information would be useful in detecting those physicians who need some kind of educational training to increase their pain management skills.
Careful interpretation of the results must be made for the following reasons. First, the differences in patient characteristics between the Saitama Cancer Center study and our study of the National Cancer Center Hospital East may explain a part of the difference in the PMI. Patients in Uki’s Saitama study were in advanced condition: 80% had metastasis, 59% had recurrent cancer and 63% had performance scores of 2 or greater. In contrast, 62% of patients in our study had metastasis, 40% had recurrent cancer and 25% had performance scores of 2 or greater. All were significantly different in chi-squared tests. These characteristics indicate that the patients in our sample were in better condition. Previous studies, as well as this one, have consistently found that patients in better condition are more likely to be undertreated for pain (8,12). Another limitation of this study is the utilization of an existing database that had been developed to study fatigue. However, the sample was thought to be representative of ambulatory cancer patients at the investigated institute, because they were randomly selected and because they had not been excluded from the original study due to specific inclusion criteria for fatigue.
Despite these limitations, this study suggests that cancer pain management at the National Cancer Center Hospital East has been inadequate to fulfill the needs of patients. As the National Cancer Center Hospital is one of the leading cancer institutions in Japan, this could be even more true for other hospitals in Japan as well. It is thus mandatory to increase medical staff awareness of symptom management and to incorporate existing knowledge into routine clinical practice in this country. Further, multicenter study is essential to assess the status of current pain management and to investigate systemic barriers against it.
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Acknowledgments |
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TOPABSTRACTINTRODUCTIONPATIENTS AND METHODSRESULTSDISCUSSIONAcknowledgmentsREFERENCES |
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The authors gratefully acknowledge the anonymous patients who cooperated so willingly. They would like to acknowledge the attending physicians for their assistance in enrolling their patients into the study: Drs H. Fujii, J. Furuse, K. Gotoh, R. Hayashi, K. Ishizawa, K. Ito, R. Kakinuma, K. Kubota, Y. Maru, T. Matsumoto, H. Minami, M. Muto, F. Nagashima, H. Ohmatsu, A. Ohtu, M. Saikawa, Y. Sano, Y. Sasaki and Y. Shima at the National Cancer Center Hospital East, Japan (alphabetical). They also would like to thank: Dr T. Takeda and Dr T. Morita, Seirei Hospice, Seirei Mikatabara Hospital, Shizuoka, Japan and Dr M. Shimoyama, Division of Pain and Palliative Medicine of National Cancer Center Hospital for giving useful comments to improve this manuscript; and Ibrahima Gning and Jeanie Woodruff, Department of Symptom Research at The University of Texas M. D. Anderson Cancer Center, for data entry and editing, respectively. This work was supported in part by Grants-in-Aid for Cancer Research (9-31) and the Second Term Comprehensive 10-Year Strategy for Cancer Control from the Ministry of Health and Welfare, Japan. Toru Okuyama is a year-2000 awardee of the American Cancer Society International Fellowship for Beginning Investigators from the International Union Against Cancer.
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FOOTNOTES |
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+ For reprints and all correspondence: Yosuke Uchitomi, Psycho-Oncology Division, National Cancer Center Research Institute East, 6-5-1, Kashiwanoha, Kashiwa, Chiba 277-8577, Japan. E-mail: yuchitom{at}east.ncc.go.jp
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REFERENCES |
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TOPABSTRACTINTRODUCTIONPATIENTS AND METHODSRESULTSDISCUSSIONAcknowledgmentsREFERENCES |
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Received August 28, 2003; accepted December 2, 2003
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