Journal of Pain and Symptom Management

A multicenter study involving six palliative care units in Italy was carried out on 159 terminal cancer patients seen at home or in hospital. The physician or the nurse completed independently from the patient the Therapy Impact Questionnaire (TIQ), a questionnaire devised for quality-of-life evaluation in terminal cancer patients. The patient's assessment was used as the valid reference measurement to compare with the health-care workers' evaluation to assess the validity of the latter. The results showed that percentages of agreement were higher for physical than for psychological and cognitive symptoms, and that there was a greater agreement on the absence rather than on the presence of a problem. None of the characteristics of the patient nor of the proxy showed any statistically significant relationship with the two disagreement indexes. The results suggest that caution is needed in the use of health-care workers as alternative sources of information regarding patients' quality of life.

The unpleasant smell of infected fungating tumors and benign cutaneous ulcers is a distressing clinical problem, known to be associated with anaerobic infection. Topical metronidazole 0.8% gel has been shown to decrease smell from fungating malodorous tumors. This study was conducted to assess prospectively the subjective and bacteriological response to 0.75% metronidazole gel to decrease smell from these lesions and to assess whether bacterial contamination of the tubes of gel occurs during use. Forty-seven patients with benign or malignant cutaneous lesions associated with a foul smell were assessed for smell, pain, appearance, and bacteriological profile before entry and at 7 and 14 days. Forty-one (95%) of the 43 patients assessed at 14 days reported decreased smell. Anaerobic infection was initially found in 25 (53%) of patients and was eliminated in 21 (84%) of these. At review after 7 days, patients reported less pain from the lesions. Discharge and associated cellulitis were also observed to decrease significantly.

Context: Breakthrough pain is common in patients with cancer and is a significant cause of morbidity in this group of patients. Objectives: The aim of this study was to characterize breakthrough pain in a diverse population of cancer patients. Methods: The study involved 1000 cancer patients from 13 European countries. Patients were screened for breakthrough pain using a recommended diagnostic algorithm and then questioned about the characteristics and management of their pain. Results: Of the 1000 patients, 44% reported incident pain, 41.5% spontaneous pain, and 14.5% a combination. The median number of episodes was three a day. The median time to peak intensity was 10 minutes, with the median for patients with incident pain being five minutes (P < 0.001). The median duration of untreated episodes was 60 minutes, with the median for patients with incident pain being 45 minutes (P = 0.001). Eight hundred six patients stated that pain stopped them doing something, 66 that it sometimes stopped them doing something, and only 107 that it did not interfere with their activities. Patients with incident pain reported more interference with walking ability and normal work, whereas patients with spontaneous pain reported more interference with mood and sleep. As well, 65.5% of patients could identify an intervention that improved their pain (29.5%, pharmacological; 23%, nonpharmacological; 12%, combination). Regarding medications, 980 patients were receiving an opioid to treat their pain, although only 191 patients were receiving a transmucosal fentanyl product licensed for the treatment of breakthrough pain. Conclusion: Breakthrough cancer pain is an extremely heterogeneous condition.

The many benefits of hospital palliative care teams (PCTs) are well known. However, their specific activities have not been fully clarified, and no standardized methods for reporting PCT activities are available. The aim of this study was to investigate, through the use of a standard format, the activities performed by hospital PCTs in Japan. This was a prospective observational study. A total of 21 hospital PCTs were included in this study, and each recruited approximately 50 consecutively referred patients. Participating PCTs filled in a standard form for reporting activities. We obtained data from 1055 patients who were referred to PCTs. Of the 1055 patients, 1005 patients (95%) had cancer. The median number of reasons for referral and problems identified by PCTs was two (0-22) and four (0-18), respectively. The two major reasons for referral were pain (63%) and anxiety/depression/grief/emotional burden (22%). The major recommendations were pharmacological treatment (74%), care for the patient's physical symptoms (49%), and support for patient's decision making (38%). The major activities performed by the PCTs were comprehensive assessment (90%), care for the patient's physical symptoms (77%), and pharmacological treatment (74%). The components of hospital PCT activities were successfully measured using the Standard Format for Reporting Hospital PCT Activity. The results of this study and the format for reporting hospital PCT activity could be effective in improving hospital PCT practice and for the education of new hospital PCT members.

Context: The efficacy and tolerability of once-daily hydromorphone extended release (ER) (OROS(®) hydromorphone ER, Exalgo(®), Mallinckrodt Brand Pharmaceuticals, Inc., Hazelwood, MO) in patients with chronic cancer and noncancer pain have been reported in previous studies. Objectives: The objective of this analysis was to assess the pooled safety data of OROS hydromorphone ER in opioid-tolerant patients with chronic cancer and noncancer pain. Methods: Safety results were pooled from 11 clinical studies in opioid-tolerant patients: one 12-week, double-blind, placebo-controlled study; three active-controlled studies; and seven uncontrolled studies (durations of three to 52 weeks). Patients were included in this analysis if they took ≥1 dose of study medication. Descriptive statistics were used to analyze baseline and demographic characteristics, supplemental analgesic use, and incidence of adverse events (AEs). Results: In total, 1251 opioid-tolerant patients received ≥1 dose of OROS hydromorphone ER. Mean (SD) duration of exposure was 43.1 (67.8) days (range 1-396 days), and mean (SD) daily dose was 43.4 (47.1) mg. Overall, 1081 patients (86.4%) used supplemental rescue analgesics. The overall incidence of AEs was 76.9%. The most frequently reported AEs were nausea (23.2%), constipation (22.4%), vomiting (14.4%), somnolence (12.9%), and headache (12.8%). Treatment-related constipation occurred in 20.5% of patients, nausea in 16.8%, somnolence in 11.8%, vomiting in 8.2%, and headache in 7.0%. Serious adverse events occurred in 13.5% of patients, with the most frequently reported serious adverse events being dehydration, nausea, and vomiting. No treatment-related deaths occurred. Conclusion: Once-daily OROS hydromorphone ER demonstrated a safety and tolerability profile in opioid-tolerant patients that is consistent with the known safety profiles of opioids.

The widespread need for palliative care has prompted the development of hospital-based palliative care consult services to provide a more interdisciplinary approach to managing advanced illness and end-of-life concerns. Establishing a successful consult service is a challenging task. This is a descriptive study of the development of a palliative care consult service (PCCS) within a non-profit, multi-hospital health system, and the five successful strategies used to optimize growth over the first five years. The PCCS is a mobile interdisciplinary team established to provide accessible, comprehensive end-of-life care and symptom management to patients with advanced illness within the health care system. Critical to its success, the team developed and maintained a database to document growth and ensure continuous quality improvement. A description of this database is provided, along with current performance outcomes. The program has prospered since its inception in 2002, with a 47% average annual growth over the first five years. The PCCS now averages 110 consults per month and has treated more than 3500 patients. This growth can be directly attributed to the five key strategies that have been used to plan, develop, and expand the program.

Little is known about the frequency, severity, and course of symptoms experienced by patients receiving radiotherapy (RT). For this descriptive study, 1129 patients with a variety of cancer diagnoses completed a 12-item Symptom Inventory (SI) at the start of RT; 419 of these patients also completed the SI weekly for an additional 4 weeks (five data points). Eighty-four percent of the 1129 patients were already experiencing symptoms when treatment began. All symptoms significantly increased in frequency over a typical 5 week RT course (all Ps<0.001). Skin problems showed the largest increase. The most common symptoms (fatigue, drowsiness, and sleep problems) were also the most severe. Female patients and patients younger than the median age (59 years) reported significantly more symptoms than males and those 59 years or older. Symptom frequency and severity varied significantly by cancer diagnosis. Improved understanding about the time course and dose response of radiation-induced toxicity will permit more accurate presentation of side effect risk at the time patient consent is obtained.

Death is often preceded by medical decisions that potentially shorten life (end-of-life decisions [ELDs]), for example, the decision to withhold or withdraw treatment. Respect for patient autonomy requires physicians to involve their patients in this decision making. The objective of this study was to examine the involvement of advanced lung cancer patients and their families in ELD making and compare their actual involvement with their previously stated preferences for involvement. Patients with Stage IIIb/IV non-small cell lung cancer were recruited by physicians in 13 hospitals and regularly interviewed between diagnosis and death. When the patient died, the specialist and general practitioner were asked to fill in a questionnaire. Eighty-five patients who died within 18 months of diagnosis were studied. An ELD was made in 52 cases (61%). According to the treating physician, half of the competent patients were not involved in the ELD making, one-quarter shared the decision with the physician, and one-quarter made the decision themselves. In the incompetent patients, family was involved in half of cases. Half of the competent patients were involved less than they had previously preferred, and 7% were more involved. Almost all of the incompetent patients had previously stated that they wanted their family involved in case of incompetence, but half did not achieve this. In half of the cases, advanced lung cancer patients-or their families in cases of incompetence-were not involved in ELD making, despite the wishes of most of them. Physicians should openly discuss ELDs and involvement preferences with their advanced lung cancer patients.

Chronic nonmalignant pain, persisting more than 6 months, affects 15%-30% of the United States population. The majority of chronic pain patients respond to a combination of physical modalities and non-opioid analgesics. However, approximately 20% do not derive sufficient pain relief from traditional measures (back surgery, oral drugs, etc.). An additional percentage of patients do not achieve a favorable balance between analgesia and side effects with systemic opioid therapy. For these patients, intraspinal delivery of opioids may improve pain relief, reduce suffering, and enhance quality of life and functional ability. Patient selection is a significant determinant of the success of this approach. Because pain is a biopsychosocial phenomenon, psychological and social assessment are essential along with adequate trials of opioid responsiveness. There are several valid approaches to conducting trials of intraspinal pain therapy including epidural and intrathecal trials. Other important issues concern trial length, the utility of placebo trials, and drug selection in cases where morphine alone provides insufficient analgesia.

We evaluated the reliability and validity of the Pediatric Functional Assessment of Cancer Therapy-Childhood Brain Tumor Survivor Questionnaire (pedsFACT-BrS, Version 2). This was specifically directed to patients aged 13 years and older (adolescents). The pedsFACT-BrS was translated and cross-culturally adapted into Korean, following standard Functional Assessment of Chronic Illness Therapy methodology. The psychometric properties of the pedsFACT-BrS in adolescents were evaluated in 161 brain tumor (BT) patients (mean age=15.53 years). Pretesting was performed in 30 patients, and the results indicated good symptom coverage and overall comprehensibility. In validating the pedsFACT-BrS for adolescents, we found high internal consistency, with Cronbach's α coefficients ranging from 0.76 to 0.91. The pedsFACT-BrS for adolescents also demonstrated good convergent and divergent validities when correlated with the Revised Children's Manifest Anxiety Scale and the Kovacs' Children's Depression Inventory. The pedsFACT-BrS for adolescents showed good clinical validity and effectively differentiated between clinically distinct patient groups according to Karnofsky score, type of treatment, and treatment on/off status. This reliable and valid instrument can now be used to properly evaluate the quality of life of Korean adolescent BT patients.

This paper reports the development and validation of a questionnaire assessing fatigue and anemia-related concerns in people with cancer. Using the 28-item Functional Assessment of Cancer Therapy-General (FACT-G) questionnaire as a base, 20 additional questions related to the symptoms and concerns of patients with anemia were developed. Thirteen of these 20 questions dealt with fatigue, while the remaining 7 covered other concerns related to anemia. Using semi-structured interviews with 14 anemic oncology patients and 5 oncology experts, two instruments were produced: The FACT-Fatigue (FACT-F), consisting of the FACT-G plus 13 fatigue items, and the FACT-Anemia (FACT-An), consisting of the FACT-F plus 7 nonfatigue items. These measures were, in turn, tested on a second sample of 50 cancer patients with hemoglobin levels ranging from 7 to 15.9 g/dL. The 41-item FACT-F and the 48 item FACT-An scores were found to be stable (test-retest r = 0.87 for both) and internally consistent (coefficient alpha range = 0.95-0.96). The symptom-specific subscales also showed good stability (test-retest r range = 0.84-0.90), and the Fatigue subscale showed strong internal consistency (coefficient alpha range = 0.93-0.95). Internal consistency of the miscellaneous nonfatigue items was lower but acceptable (alpha range = 0.59-0.70), particularly in light of their strong relationship to patient-rated performance status and hemoglobin level. Convergent and discriminant validity testing revealed a significant positive relationship with other known measures of fatigue, a significant negative relationship with vigor, and a predicted lack of relationship with social desirability. The total scores of both scales differentiated patients by hemoglobin level (p < 0.05) and patient-rated performance status (p < 0.0001). The 13-item Fatigue subscale of the FACT-F and the 7 nonfatigue items of the FACT-An also differentiated patients by hemoglobin level (p < 0.05) and patient-rated performance status (p < or = 0.001). The FACT-F and FACT-An are useful measures of quality of life in cancer treatment, adding more focus to the problems of fatigue and anemia. The Fatigue Subscale may also stand alone as a very brief, but reliable and valid measure of fatigue.

This study aimed to examine how symptoms vary in relation to demographic characteristics (age and sex), stage of disease, histology of lung cancer, and treatment type in Korean adults with lung cancer. Symptoms were measured with the Symptom Distress Scale. A total 106 patients with a mean age of 60.9 (SD = 10.38) years participated. The results indicated that 1) overall symptom distress was more severe (mean 32.74, SD 10.75) compared to the studies reported in Western countries, and 2) among the variables, only the stage of lung cancer showed a significant relationship with total symptom distress (P < 0.05). In analyses of the individual symptoms, bowel-related symptoms showed significant relationships with sex, age, and type of treatment. The results highlight the importance of symptom management as well as the need to tailor clinical interventions according to related factors in order to maximize effective symptom management in Korean patients with lung cancer.

A growing body of evidence is documenting the multidimensional nature of cancer-related fatigue. Although several multidimensional measures of fatigue have been developed, further validation of these scales is needed. To this end, the current study sought to evaluate the factorial and construct validity of the 30-item Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF). A heterogeneous sample of 304 cancer patients (mean age 55 years) completed the MFSI-SF, along with several other measures of psychosocial functioning including the MOS-SF-36 and Fatigue Symptom Inventory, following the fourth cycle of chemotherapy treatment. The results of a confirmatory factor analysis indicated the 5-factor model provided a good fit to the data as evidenced by commonly used goodness of fit indices (CFI 0.90 and IFI 0.90). Additional evidence for the validity of the MFSI-SF was provided via correlations with other relevant instruments (range -0.21 to 0.82). In sum, the current study provides support for the MFSI-SF as a valuable tool for the multidimensional assessment of cancer-related fatigue.

Pain beliefs as indexed by the Survey of Pain Attitudes (SOPA) have been consistently shown to predict pain adjustment outcomes in Western populations. However, its utility in non-Western populations is unclear. We evaluated the construct and predictive validity of the Chinese version of the 14-item SOPA (ChSOPA-14) in a sample of Chinese patients with chronic pain. A total of 208 Chinese patients with chronic musculoskeletal pain completed the ChSOPA-14, the Chronic Pain Grade questionnaire, the Pain Catastrophizing Scale, the Center for Epidemiological Studies-Depression Scale, and measures of sociodemographic characteristics. Except Medical Cure, all ChSOPA-14 scales were significantly correlated with validity criterion measures (all P<0.05) in expected directions. The present Chinese sample scored the highest on the Medical Cure scale (mean=2.98, standard deviation [SD]=1.05) but the lowest on the Disability scale (mean=1.75, SD=1.67). Results of hierarchical multiple regression analyses showed that the ChSOPA-14 scales predicted concurrent depression (F(7,177)=14.51, P<0.001) and pain disability (F(7,180)=8.77, P<0.001). Pain Control (stdβ [standardized beta coefficient]=-0.13; 95% confidence interval [CI]: -3.41, -0.13; P<0.05) and Emotion (stdβ=29; 95% CI: 1.76, 5.02; P<0.001) emerged as significant independent predictors of concurrent depression whereas Disability (stdβ=0.19; 95% CI: 1.33, 7.88; P<0.01), Emotion (stdβ=16; 95% CI: 0.08, 7.59; P<0.05), and Solicitude (stdβ=-0.14; 95% CI: -7.05, -0.04; P<0.05) significantly associated with concurrent disability. The findings offer preliminary evidence for the construct and concurrent predictive validity of the ChSOPA-14. This makes available a suitable instrument for chronic pain in the Chinese population and will facilitate future cross-cultural research on pain beliefs.

Literature on assessment of symptom distress has focused primarily on patients' and nurses' perceptions in the hospital setting. To date, no research has examined behavioral measurement and cues that primary family caregivers respond to when assessing patients' level of distress arising from individual symptoms in the home setting. The qualitative data obtained from 37 primary family caregivers of patients with lung cancer was designed to augment quantitative results discussed elsewhere. Content analysis was performed on written responses to an open-ended questionnaire in which family caregivers identified cues that they responded to when assessing patients' distress from symptom items. The results identified the categories of impaired functioning and verbal cues as the most frequent indices of symptom distress. This study documents that certain behavioral measures for assessing symptom distress may be clinically useful to observers. Primary family caregivers are shown in this study to take a limited multidimensional approach in the assessment of patients' distress from symptoms.

Data from 1413 outpatients in community-based clinical practices were collected in order to characterize the use and effectiveness of 5-HT(3) receptor antagonists for control of chemotherapy-induced nausea and vomiting (NV). Patients were divided by treatment starting date into six cohorts for trend analysis. In addition, NV symptoms were compared in 252 patients treated prior to the commercial introduction of the 5-HT(3) receptor antagonist antiemetics, and an equal number of patients treated after their introduction. A comparison of cohorts revealed a significant (P = 0. 027) downward trend over time for the frequency of post-treatment vomiting episodes, but not for frequency of post-treatment nausea (P = 0.69). The average duration of nausea following treatment increased significantly over time (P = 0.003). Although the introduction of 5-HT(3) receptor antagonist antiemetics has apparently led to a significant reduction in the frequency of post-treatment vomiting, there has been an accompanying increase in the duration of post-treatment nausea.

This article presents a synopsis of the psychosocial needs of patients and families in the terminal phase of malignant disease, as well as approaches to auditing the care of these clients. Recommendations for future research from the National Cancer Institute of Canada Workshop on Symptom Control and Supportive Care in Patients with Advanced Cancer are presented. These include recommendations on the need for more effective tools to measure the symptoms and burden of illness; an improved taxonomy to describe terminal illness; and studies to (1) measure the impact of interventions for improved symptom relief on the psychosocial distress of patients and families, (2) determine the impact of psychosocial interventions on the symptomatology associated with terminal illness, (3) operationalize "good palliative care" and the optimal delivery of palliative care, (4) assess the auditing of palliative care, (5) develop family typologies of adaptation to terminal illness, (6) describe high risk families, and (7) measure the impact of staff support programs on improving patient/family care.

In our previous work, we established interference-based cut-points to differentiate moderate from mild, and severe from moderate levels of severity for 16 symptoms as reported by cancer patients undergoing chemotherapy. This work examines how consistent the differentiation is over time. If the levels of severity successfully differentiate interference scores over time, then anchor-based categories can be developed to evaluate patients' responses to the intervention. To test the differentiation of the interference scores by the three severity categories, data from two symptom management trials were used. Five hundred and ninety-nine patients were queried at each of the six contacts that occurred over eight weeks as to the severity of each of the 16 symptoms on the scale from 0 (not present) to 10 and the extent to which each symptom interfered with enjoyment of life, relationships with others, general daily activities and emotions. Longitudinal models that related interference scores to severity levels of symptoms were used. Differences among adjusted mean interference scores for mild, moderate, and severe levels were tested at each contact. Differences among interference-based severity categories were consistent over time and clinically important, and thus can be used to anchor changes in symptom severity.

In a prospective study, the prevalence of 15 physical symptoms and symptom groups was evaluated in 1635 cancer patients referred to a pain clinic. In addition to pain, patients suffered an average of 3.3 symptoms: insomnia (59%), anorexia (48%), constipation (33%), sweating (28%), nausea (27%), dyspnea (24%), dysphagia (20%), neuropsychiatric symptoms (20%), vomiting (20%), urinary symptoms (14%), dyspepsia (11%), paresis (10%), diarrhea (6%), pruritus (6%), and dermatological symptoms (3%). While symptom prevalence was influenced by tumor site, pain intensity, and opioid treatment, only a minor relationship was seen between symptoms and gender, age, or tumor stage. The data emphasize that it is not sufficient to simply address pain during the treatment of patients with cancer pain; a more global approach to symptom management is necessary.

Context: Previous studies have revealed inconsistent findings about the longitudinal evolution of cancer-related symptoms. In addition, the contribution of medical factors (e.g., cancer site, and treatments) in explaining the changes in these symptoms is yet to be established. Objectives: This prospective study investigated longitudinal changes of five symptoms (i.e., depression, anxiety, insomnia, fatigue, and pain) in patients scheduled to undergo surgery for cancer (N=828). Methods: The patients completed the Hospital Anxiety and Depression Scale, the Insomnia Severity Index, the Multidimensional Fatigue Inventory, and a pain questionnaire at baseline and after 2, 6, 10, 14 and 18 months. Results: Several time changes were statistically significant but effect sizes only revealed one change of a medium magnitude, that is, a reduction of anxiety from T1 to T2 (d=-0.58). Women with breast or gynecological cancer were the only subgroups to exhibit significant changes (i.e., reduction of a small magnitude of anxiety symptoms from T1 to T2; ds=-0.27 and -0.30, respectively). However, numerous differences were found across adjuvant treatments, including greater variations in depression and insomnia scores in the chemotherapy group (ds=-0.71 to 0.20) and a transient increase in fatigue symptoms in patients receiving "all" adjuvant treatments (ds=-0.24 to 0.37). Conclusion: The severity of cancer-related symptoms varies during the cancer care trajectory, especially anxiety scores, which importantly decrease during the first few months after the surgery. This study also suggests that treatment regimens better account for individual differences than cancer site in the evolution of symptoms.

Breakthrough pain (BTP) is highly prevalent in patients with chronic cancer and noncancer pain, commonly requiring treatment with short-acting or rapid-onset opioids. This is the first report of an analysis of long-term safety from combined clinical trials of a rapid-onset transmucosal formulation of fentanyl, the fentanyl buccal tablet (FBT). This long-term (18-month), open-label study assessed the safety and tolerability of FBT for the treatment of BTP in a large cohort (n=646) of opioid-tolerant patients receiving around-the-clock (ATC) opioids for persistant noncancer pain. This was a long-term, multicenter, open-label safety study that accepted patients naïve to FBT (new patients) as well as rollover patients from one of two previous short-term, randomized, placebo-controlled studies involving opioid-tolerant adults with chronic noncancer pain. All patients gave written informed consent, and the study was conducted according to Good Clinical Practice and with Independent Ethics Committee or Institutional Review Board approval. During maintenance treatment, 70 of 646 patients (11%) discontinued because of adverse events (AEs), 69 of 646 (11%) because of withdrawn consent, and 57 of 646 (9%) because of noncompliance. A total of 571 of 646 patients (88%) had one or more AEs; most were mild to moderate in intensity and typical of AEs associated with opioid use in a noncancer chronic pain population. Serious AEs were seen in 118 of 646 patients (18%); most were considered by the investigators to be unrelated or unlikely to be related to FBT. There were six deaths (three myocardial infarction, two cardiac arrest, and one pneumonia) that were considered by investigators to be unrelated or unlikely to be related to FBT. There were two reports of accidental overdose contained within nine reports of nonfatal overdose (FBT and/or ATC and/or other medications). Four patients had AEs of abuse or drug dependence, two in association with FBT. Drug withdrawal syndrome occurred in 23 patients after discontinuation of FBT alone or in combination with other opioids. Secondary assessments showed that average pain ratings, as assessed by the Brief Pain Inventory, remained relatively stable throughout the study and that consistent improvements were noted in functional measures. FBT was generally safe and well tolerated, with self-reported functional improvement observed in most of the opioid-tolerant patients with BTP in association with chronic noncancer pain.

The purposes of this study were 1) to assess and describe the occurrence, frequency, severity, and distress of symptoms reported by Taiwanese pediatric cancer patients who were between 10 and 18 years of age, and 2) to use statistical analysis to determine whether the multiple dimensions (i.e., frequency, severity, or distress) of the Memorial Symptom Assessment Scale (MSAS) 10-18 alone can provide sufficient useful information for the assessment of symptoms that patients report as distressing. A total of 144 Taiwanese pediatric cancer patients and their mothers participated in this cross-sectional study. The frequency of symptoms for all patients ranged from 52% for "lack of energy" to 10% for "feeling nervous." The most common symptoms (occurrence >40%) were "lack of energy," "lack of appetite," "feeling drowsy," "sweating," "worrying," "nausea," "dry mouth," "pain," and "lack of concentration." Patients in the "on-treatment group" had more distressing symptoms than those in the "off-treatment group." The severity and distress subscales did provide the most information for symptom assessment and were the two best subscales to represent the impact of symptoms on quality of life, fatigue, and internalizing behaviors. The findings of this study suggest that revising the current format of the MSAS 10-18 into three separate instruments (one for each of the subscales) might provide more accurate data for assessments. Such a modification would change the scoring system and provide for more accurate data analysis.

Conceived as a World Health Organization demonstration project for public health initiatives at the end of life, the palliative care program in Catalonia illustrates the impact that similar initiatives may have in terms of cost savings for a regional health system. In a publicly funded and freely accessible health system, decreasing the number of hospital admissions, shortening the lengths of hospital stay, diminishing the frequency of emergency room consultations, shifting the use of acute hospital beds to palliative care beds for treating advanced disease inpatients, and substantially improving the use of opioids in the community are major determinants of the palliative care program's success. These features add to the opportunity the discipline offers to improve the quality of health care at the end of life. In this article, the information gathered over an 18-year trajectory of the program is summarized. Key features of the existing financial models used while developing palliative care in Catalonia are described, and the mechanisms by which palliative care may have contributed to increase savings for the health care system in end-of-life care, from euro3,000,000 in 1995 to euro8,000,000 in 2005, are discussed.

One hundred and ninety-one patients with postherpetic neuralgia (PHN) in whom treatment was begun 3 or more months after acute herpes zoster (HZ) were retrospectively considered. Relieved (> or = 75% fall in visual analogue score for worst pain within last 24 hr) and unrelieved groups were subdivided into those who had and those who had not received antiviral treatment for their acute shingles. More than 90% of all patients experienced allodynia with a clinically evident sensory deficit for temperature and/or pinprick sensation. The probability of relief is worst in patients with PHN of the isolated ophthalmic nerve and of the brachial plexus, and best when involving the jaw, neck, and trunk. The presence (90%) or absence of allodynia has no predictive significance; but the small number of patients without allodynia or sensory deficit (all of whom had had antiviral treatment for their acute shingles) all improved. The probability of pain relief was found to correlate very strongly with the brevity of the interval between rash onset and commencement of treatment with an adrenergically active antidepressant. Further, time to relief in patients treated with an antidepressant starting at the same interval after HZ is significantly shorter in patients who received acyclovir for their original HZ. With the possible exception of dextroamphetamine added to the antidepressant, other treatments (particularly analgesics, anticonvulsants, and sympathetic blockade) were found to be without value in most cases. Thirty percent of patients who recover from PHN and have had their original shingles treated with acyclovir subsequently suffer from severe itching. It is recommended that elderly patients be given low-dose antidepressant on diagnosis of shingles, and asked to report back in 6 weeks. If they are pain-free at this interval, low-dose antidepressant should be continued for another month or so and then stopped. If, however, pain is present at 6 weeks, the dose of antidepressant should be increased and the patient reviewed every 2 months.

Three strands of activity can be identified in the history of pain measurement. The first, psychophysics, dates back to the nineteenth century and measures the effect of analgesia by quantifying the noxious stimulation required to elicit pain, as well as the maximum stimulation tolerated. The second uses standardized questionnaires for patients, developed to categorize pain according to its emotional impact, distribution, character, and other dimensions. The third asks patients to report on pain intensity using rating scales, and is used in clinical trials where analgesics are evaluated and results can be combined to influence clinical guidelines and protocols. Although all three strands have found a place in modern clinical practice or drug development, it is the reporting of pain by patients undergoing treatment using simple scales of intensity which has emerged as the crucial method by which analgesic therapies can now be evaluated and compared.

We reviewed the charts of 48 consecutive patients treated by our Palliative Care Team (PCT) during 1984 and compared these results with 50 consecutive patients treated during 1987. The composition of the PCT did not change between 1984 and 1987. The median equivalent daily dose of parenteral morphine (MEDD) before referral, after initial treatment by the PCT, and at the maximum prescribed by the PCT were 43 mg, 48 mg, and 96 mg in 1984, respectively, versus 60 mg (p less than 0.03), 60 mg (p less than 0.03), and 120 mg (p less than 0.12) in 1987, respectively. Seventeen of 43 patients were receiving mild narcotics in 1984 versus 7 of 48 patients in 1987 (p less than 0.01). Parenteral narcotics were used initially in 2% of patients in 1984 versus 46% of patients in 1987 (p less than 0.001). Poor pain control after the initial treatment was observed in 42% of patients in 1984 versus 26% in 1987 (p less than 0.01). Our results suggest that patients are being treated more aggressively by their physicians before referral to the PCT in 1987, that our PCT is using more aggressive initial treatment than in 1984, and that, notwithstanding these changes, there is still a significant proportion of patients in whom pain cannot be controlled before death. These results suggest that more research is necessary to better define intractable pain syndromes and develop adequate treatments for them.

In the last few years, palliative care for advanced and terminal cancer patients has undergone considerable evolution. We determined the characteristics of patients admitted to the 4-bed Palliative Care Unit (PCU) of the National Cancer Institute (NCI) of Milan in 1987, 1993 and 2000 to evaluate how our diagnostic and therapeutic approaches have changed over the years. We reviewed the charts of every patient admitted to the PCU in 1987, 1993, and the first ten months of 2000. We recorded demographic data; the primary tumor sites; the main reason for admission; the types of therapies administered (oncologic, analgesic, surgical, neurosurgical analgesic procedures, and supportive therapy); the type and number of cardiological, radiological and endoscopic examinations, as well as specialist consultations; the duration of stay and eventual death on the Unit. There were no significant differences regarding gender, age, primary tumor site and death in hospital of the patients admitted during these years. The time spent in hospital increased over time (P = 0.006). A significant increase was observed in the percentage of patients admitted for supportive therapy (P < 0.001) and investigation concerning the stage of the disease (P < 0.001). There was a significant decrease in admission for invasive analgesic procedures (P < 0.001), as well as for pain diagnosis and/or uncontrolled pain. Uncontrolled pain remained the most frequent reason for admission. Over the years, during hospitalization, 7% to 12% of the patients underwent radiotherapy,1% to 9% had computerized tomography, and 4% to 8% had palliative surgery. More than 50% of the patients received intravenous hydration; a few patients received hypodermoclysis in 1987. Over time, there was a significant increase in "as needed" administration of nonsteroidal anti-inflammatory drugs and a significant reduction in their regular administration (from 24% in 1987 and 1993 to 3% in 2000) (P < 0.001). The use of codeine, tramadol and methadone increased (P < 0.001), whereas the use of oral morphine, buprenorphine and oxycodone decreased in 2000 (P < 0.001). There was a reduction in the use of antidepressants (no significant constant trend) and a significant increase in the use of anticonvulsants, laxatives and pamidronate (P < 0.001). Regularly administered hypnotics decreased in 1993 and increased in 2000 (P < 0.001). Over these years, no significant differences were found in the routes of opioid administration, in route switching and in the mean maximum oral opioid dose (ranging from 108 to 126 mg/day). The percentage of patients undergoing percutaneous cordotomy significantly decreased in 1993 and 2000 (P < 0.001). Over time, there was an increase in requests for specialist consultations, which was significant for neurological, cardiological and oncological consults (P < 0.001). Although the characteristics of the patients admitted to the PCU did not change over these years, there have been significant modifications in our therapeutic approaches, above all in the use of supportive therapy, adjuvant drugs, opioids and neurosurgical invasive procedures. Moreover, a major collaborative interaction with other specialists of the NCI took place with the aim to tailor treatment for each single patient.

Finland belongs to the group of countries in which the consumption of strong opioids is low. This seems to reflect the general quality of cancer pain treatment. During the last 10 years, many efforts have been made to improve the treatment of cancer pain in Finland. To assess one parameter of change, the present study compared the quantity of opioid and nonopioid analgesics used in the treatment of terminal cancer pain in a Finnish general hospital in 1987, 1991, and 1994. Specifically, the records of all patients who died of cancer in Kymenlaakso Central Hospital (KCH) in 1991 and in 1994 and during the last 6 months of 1987 were reviewed to acquire information about the use of analgesic medication. The total proportion of cancer patients receiving analgesic medication on a regular basis was 39% in 1987, 63% in 1991, and 52% in 1994. The mean daily dose of strong opioids changed from 24 mg in 1987 to 58 mg in 1991, and to 43 mg in 1994. These data suggest a possible backlash in prescribing practices during recent years. In spite of various efforts to improve the treatment of cancer pain, the medical records demonstrate a decline in prescribing of the drugs needed for this treatment.

Home care is greatly expanding because of the savings it offers by avoiding unnecessary hospitalization and also because patients benefit from being in their own home environments. Since 1988, Societa Assistenza Malato Oncologico Terminale (SAMOT) has organized a pain relief and home palliative care unit for terminal cancer patients. Objectives, difficulties, protocols, and achievements of 4 years of experience were examined, and the findings of the various years were compared. Our results suggest that considerable progress has been made in home palliative care. There are still social and cultural difficulties to overcome, however.

Palliative medicine is an emerging world-wide discipline. This article describes efforts at the Medical College of Wisconsin (MCW) to develop programs to enhance palliative medicine education and clinical care. New courses, seminars and clinical programs have been developed. Education and clinical care activities since 1990 have included a required course for second-year medical students, clinical electives for third- and fourth-year medical students, a clinical palliative care consultation service, a palliative care seminar series designed for housestaff, and a nurse preceptorship program. Palliative medicine activities have included both the academic medical center and community health agencies. MCW has integrated palliative medicine into its academic environment so that trainees at all education levels now have opportunities for didactic and clinical end-of-life care education.

A global, comprehensive, publicly planned and financed program to implement palliative care was designed by the Department of Health of Catalonia (6 million inhabitants. Planned in collaboration with the cancer unit of the WHO in 1989, the program was implemented in 1990-1995. It included specific services, measures general resources, education and training, organizational and educational standards, opioid availability, legislation and evaluation. The aims included coverage for cancer, AIDS, geriatric and other conditions, equity, quality, reference, and satisfaction for patients, families, and professionals. The results in 1995 include the implementation of 18 hospital support teams and 19 Units, with a total of 350 beds, 42 home-care teams. The coverage for cancer and AIDS is around 40%, and 44/55 (80%) districts have a specific team. Palliative care implementation has been completely publicly financed, with a total yearly investment of 2,200 million ptas. Eighty percent of this has been saved through radical changes in costs and the pattern of the use of resources. Palliative care implementation has demonstrated efficacy in the care of the patients and families, efficiency in the provision of care, and cost-benefit in the regional global approach. It adds qualitative and organizational values to the health-care system. Its implementation must be prioritized and planned by the health administration, not only to improve the quality of care for advanced and terminal patients, but also to improve the global efficiency and appropriate use of resources in the public health system.

Several studies have shown that place of death is affected by many parameters. Our objective was to describe for the first time where patients with cancer die in Greece and what has changed between 1993 and 2003. We acquired data on all deaths that were attributed to cancer in Greece in the years 1993 and 2003, and compared these data to the changes in the location of death in the total population. In 1993, approximately 50.7% of men and 50.9% of women cancer patients died in hospital, while in 2003, the respective percentages were 57.3% and 56.1%. The results indicate a trend toward a larger proportion of hospital deaths over this interval. This should be taken under consideration for future planning of end-of-life care in Greece.

This study sought to update national estimates of the use of alternative therapies, to improve the quality of those estimates, and to examine differences between users and nonusers of alternative medicine. Data were analyzed from the general probability sample (N = 3450) of the 1994 Robert Wood Johnson Foundation National Access to Care Survey. The results indicate that nearly 10% of the U.S. population, almost 25 million persons, saw a professional in 1994 for at least one of the following four therapies: chiropractic, relaxation techniques, therapeutic massage, or acupuncture. Even though users of alternative therapies made almost twice as many visits to conventional (or orthodox) medical providers as nonusers made, the former still reported much higher levels of unmet need for medical care. The growing emphasis on market-driven health care and consumer choice suggests that alternative therapies could have a larger role in the health-care system of the future.

This study updates a previous analysis of trends in medical use and abuse of opioid analgesics, and provides data from 1997 through 2002. Two research questions were evaluated: 1) What are the trends in the medical use and abuse of frequently prescribed opioid analgesics used to treat severe pain, including fentanyl, hydromorphone, meperidine, morphine, and oxycodone? 2) What is the abuse trend for opioid analgesics as a class compared to trends in the abuse of other drug classes? Results demonstrated marked increases in medical use and abuse of four of the five studied opioid analgesics. In 2002, opioid analgesics accounted for 9.85% of all drug abuse, up from 5.75% in 1997. Increase in medical use of opioids is a general indicator of progress in providing pain relief. Increases in abuse of opioids is a growing public health problem and should be addressed by identifying the causes and sources of diversion, without interfering with legitimate medical practice and patient care.

The aim of this review was to evaluate the methods of pain measurement in controlled clinical trials in oncology published between 1999 and 2002. An electronic literature search strategy was used according to established criteria applied to the Medline database and PubMed search engine. Articles were selected to include only studies that had chronic cancer pain as the primary or secondary objective of a controlled clinical trial. A specific evaluation scheme was used to examine how pain measurement methods were chosen and implemented in the study procedures. The search strategy identified 613 articles, and 68 were selected for evaluation. Most articles (69%) chose unidimensional pain measurement tools, such as visual analogue scales, numerical rating scales and verbal rating scales, whereas others used questionnaires. The implementation of the pain assessment method was problematic in many studies, especially as far as time frame of pain assessment (70%), administration modalities (46%), and use of non-validated measurement methods (10%). Design of study and data analysis were often unclear about the definition of pain outcome measure (40%), patient compliance with pain assessment (98%), and impact of missing data (56%). Statistical techniques were seldom appropriate to the type of data collected and often inadequate to describe the pain variable under study. It is clear from this review that most authors were aware of the need of valid pain measurement tools to be used in clinical trials. However, too often these tools were not appropriately used in the trial, or at least their use was not described with sufficient accuracy in the trial methods.

The Patient Care Monitor (PCM) is a review of systems survey delivered by means of an electronic patient-reported outcomes (ePRO) data capture system that uses wireless tablet computers. Although the PCM 1.0 is validated, the updated PCM 2.0 has not been validated nor tested in the academic setting. To validate and test the PCM 2.0 in three cancer populations. Two hundred seventy-five individuals participated in three clinical trials enrolling breast (n=65), gastrointestinal (n=113), and lung (n=97) cancer patients. Internal consistency was evaluated using Cronbach's alpha coefficients calculated for six PCM subscales (general physical symptoms, treatment side effects, distress, despair, impaired performance, and impaired ambulation) and a Quality-of-Life Index. Construct validity was evaluated through Pearson's correlation between PCM subscales and subscales of the Functional Assessment of Cancer Therapy--General (FACT-G), the M.D. Anderson Symptom Inventory (MDASI), and the Functional Assessment of Chronic Illness Therapy--Fatigue (FACIT-F). The participants had the following characteristics: mean age was 58 years (standard deviation: 11), 52% were females, 79% were whites, 17% were blacks, 62% had no college degree, and 78% had metastatic or recurrent disease. Raw and normalized scores for PCM 2.0 subscales were internally consistent across study cohorts. PCM 2.0 subscales correlated significantly (P<0.05) with the corresponding subscales on FACT-G, MDASI, and FACIT-F, with the exception of FACT-G social well-being, particularly for the lung cancer population. These correlations demonstrated construct validity. PCM 2.0 results followed expected patterns by cancer etiology. Prior reports demonstrate patient satisfaction with PCM 2.0. Within three unique academic oncology populations, PCM 2.0 is a valid ePRO instrument for assessing symptoms with seven patient-centered subscale or index domains.

Nineteen of 25 patients (14 female) with advanced malignant disease completed a randomized controlled trial of a new high-dose (200 mg) tablet formulation of controlled-release morphine. Compared with the currently available 100-mg tablets there were no differences in pain severity or adverse effects with the new formulation. In four patients, full 12-hr plasma morphine concentration profiles at steady state were obtained and showed no significant differences between the same dose provided as 100-mg and 200-mg tablets in Cmax, tmax, or other pharmacokinetic indices.

The analgesic efficacy of supplemental interligamentary fentanyl injection for management of endodontic debridement patients was investigated through a randomized, double-blind study. Forty patients who presented with acute symptomatic irreversible pulpitis of the upper first molar tooth participated in the study. Patients were scheduled for endodontic debridement, for which infiltration anesthesia with 1.8 ml of 2% mepivacaine with epinephrine 1:200,000 was the standard primary anesthetic technique. Patients were randomly divided into two equal groups. The first group received supplemental interligamentary injection with 0.4 ml fentanyl 0.05 mg/ml, while the second group received supplemental interligamentary injection with 0.4 ml mepivacaine with epinephrine 1:200,000. The intraligamental-injected drug was given as 0.2 ml on the mesial and 0.2 ml on the distal aspect of the tooth. Results indicated that fentanyl provided relatively greater analgesia, yielding satisfactory relief during different stages of the procedure, including access cavity preparation, pulpotomy, and pulp extirpation. Fentanyl is effective when used in conjunction with local anesthetics to provide adequate analgesia during endodontic debridement, and this finding provides strong evidence that peripheral actions are involved in the analgesia produced by opioid drugs in inflammatory pain.

To facilitate utilization of hospice services, Taiwan uses the National Health Insurance (NHI) as a major policy instrument. To evaluate the effect of this policy on hospice utilization by cancer patients during their final year of life, a retrospective cohort study was conducted by linking individual patient-level data from the National Register of Deaths Database and the NHI claims database to examine changes in the rates of hospice utilization, durations of patient survival (DOS) after enrollment, and the rates of late referrals to hospice care from 2000 to 2004. Among the 103,097 cancer patients who died between 2000 and 2004, the rate of hospice utilization during their final year of life grew substantially from 5.5% to 15.4%. However, Taiwanese cancer patients were enrolled in hospice care close to death (median DOS ranged from 14 to 47 days). Except for the small proportion of patients who received both inpatient hospice care and hospice home care, one-third to one-fourth of cancer decedents died within 7 days after being enrolled in hospice care. Although the rate of late referrals to hospice care did not vary much over time, the mean DOS for hospice care changed significantly. Many Taiwanese cancer patients who could potentially benefit from hospice care do not receive it in time. Further research is warranted to investigate factors influencing hospice use and the timing of hospice referrals to facilitate appropriate use of hospice care for cancer patients in Taiwan.

Palliative care patients are highly prothrombotic, yet there are no national guidelines for the prevention of venous thromboembolism (VTE). A survey was undertaken to explore thromboprophylaxis practice within British palliative care inpatient units and whether it changed over 5 years in keeping with emerging evidence. A descriptive semistructured telephone survey was conducted in April, 2000 and March, 2005 to explore current thromboprophylaxis practice. Seventy-four percent of units participated in 2000 and 91% participated in 2005. Units surveyed in 2000 revealed that 2% had thromboprophylaxis guidelines and up to 75% would stop ongoing low molecular weight heparin (LMWH) in a highly prothrombotic, good prognosis inpatient. The survey in 2005 indicated that thromboprophylaxis guidelines were being developed in 19% of units and only 18% of units surveyed would stop LMWH in a patient already receiving thromboprophylaxis (P < 0.001). There appears to be a growing awareness of the problem of VTE in British palliative care inpatients, as evidenced by changes in attitudes and practice. Reasons for this are discussed.

Consensus guidelines developed by an expert panel are helpful to clinicians when there is variation in practice and lack of a firm evidence base for an intervention, such as intraspinal therapy for pain. An internet-based survey of practitioners revealed remarkable variation in practice patterns surrounding intraspinal therapy. This prompted an interdisciplinary panel with extensive clinical experience in intraspinal infusion therapy to evaluate the results of the survey, the systematic reviews of the literature pertaining to this approach, and their own clinical experience with long-term spinal infusions. The panel proposed a scheme for the selection of drugs and doses for intraspinal therapy, and suggested guidelines for administration that would increase the likelihood of a successful outcome. These expert panel guidelines were designed to provide an initial structure for clinical decision making that is based on the best available evidence and the perspectives of experienced clinicians.

Context: In Korea, many health care professionals have shown increased concern about the management of cancer pain. Five years after a pain management guideline was distributed to Korean physicians, the Korean Society of Hospice and Palliative Care evaluated the change in cancer pain management. The period evaluated was between 2001 and 2006. Methods: We did a prospective, cross-sectional cancer pain survey on the change of the pain prevalence and pain intensity, its impact on daily activities and the adequacy of pain management between 2001 and 2006. Results: Overall, 7565 patients were enrolled from 72 cancer hospitals in the 2001 cancer pain survey and 7245 patients were enrolled from 63 cancer hospitals in the 2006 cancer pain survey. The overall prevalence of cancer pain and the percentage of patients reporting a negative pain management index were significantly decreased in the 2006 cancer pain survey compared with the 2001 cancer pain survey (44.9% vs. 52.1%, P<0.0001 and 41.6% vs. 45.0%, respectively, P=0.0005). However, in 2006, physicians did not prescribe analgesics to 25.8% of the patients with severe pain and they did not adjust the prescribed analgesics properly in 47.4% of the patients with severe pain. Conclusion: Some improvement in cancer pain management was noted during the five years between 2001 and 2006. However, all of the physicians who care for cancer patients should pay more attention to cancer pain management, and an educational program for cancer pain management should be distributed to all of the physicians who care for cancer patients.

Hospice care has increasingly been shown to affect quality of palliative care at both the individual and institutional levels. However, an institutional effect has only been addressed in single comprehensive cancer centers/selected community hospitals. To investigate the impact of an inpatient hospice unit on the parent hospital's quality of palliative care. This was a retrospective cohort study using administrative data from the entire population of 204,850 Taiwanese pediatric and adult cancer patients who died in 2001-2006. Outcome variables were adjusted by multivariate logistic regression for five groups of confounding variables: 1) patient demographics and disease characteristics, 2) primary hospital characteristics, 3) primary physician specialty, 4) health care resources at the hospital and regional levels, and 5) historical trend. Taiwanese cancer patients who received primary care in a hospital with an inpatient hospice unit (whether or not they received hospice care) were significantly less likely to be intubated (adjusted odds ratio [AOR]: 0.71; 95% confidence interval [CI]: 0.58, 0.86) and use mechanical ventilation support (AOR: 0.70; 95% CI: 0.56, 0.87) in their last month of life. They also were more likely to use hospice care before death (AOR: 3.51; 95% CI: 1.57, 7.86). Furthermore, if they used hospice care, they tended to be referred earlier than cancer patients being cared for in a hospital without an inpatient hospice unit. Integrating both acute care and palliative care approaches to caring for terminally ill cancer patients in the same hospital may influence the quality of palliative care throughout the hospital as evidenced by our findings that these patients have lower likelihood of being intubated with mechanical ventilation support in the last month of life, greater propensity to receive hospice care in the last year of life, and a trend toward earlier referral to hospice care. The generalizability of these results may be limited to patients who died of a noncancer cause and by the two groups not being exactly matched for patients' characteristics.

The discrepancy between patients' preferred and actual place of death highlights the dilemma inherent in achieving their preferences for home death. Research on determinants of home death has been limited largely by focusing on individual-level factors and somewhat on health care resources at the primary hospital and regional levels. To investigate factors associated with home death, specifically, services received by cancer patients at the end of life (EOL). This was a retrospective cohort study using administrative data from 201,201 Taiwanese cancer decedents in the period 2001-2006. Rates of home death decreased significantly over time (from 35.67% to 32.39%). Dying at home was associated with patient demographics (gender, age, and marital status) and disease characteristics (cancer type, metastatic status, postdiagnosis survival time, and comorbidity level). Taiwanese cancer patients were less likely to die at home if they received care from a medical oncologist and in hospitals or regions with abundant health care resources. Furthermore, Taiwanese cancer patients were less likely to die at home if they used life-sustaining treatments (intensive care unit care, cardiopulmonary resuscitation, intubation, and mechanical ventilation) in the last month of life. However, multiple emergency room visits in the last month of life and receiving hospice care increased Taiwanese cancer patients' propensity to die at home. Despite the causal ambiguity in interpreting our research findings, they indicate that using life-sustaining treatments at EOL not only exacts a substantial toll from patients, family members, and society, but also decreases the likelihood of dying at home.