Journal of Pain and Symptom Management - Articles in Press

Spontaneous Cervical (C1–C2) Cerebrospinal Fluid Leakage Repaired with Computed Tomography-Guided Cervical Epidural Blood Patch - Corrected Proof

2010-07-30

Intracranial hypotension syndrome (IHS) is often caused by persistent cerebrospinal fluid (CSF) leakage. IHS usually presents with orthostatic headache, exacerbated by an increase in intracranial pressure, but other symptoms can be present such as nausea, vomiting, dizziness, neck pain, and paresis of the VIth cranial nerve. It can be spontaneous or related to a trauma, such as dural puncture or surgery, or medical causes such as dehydration. Thanks to improvements in neuroradiological imaging quality, magnetic resonance imaging (MRI) diagnosis of IHS is now more common and easier.

A Review of the Literature on the Multiple Dimensions of Chronic Pain in Adults with Sickle Cell Disease - Corrected Proof

2010-07-26

Abstract: Sickle cell disease (SCD) is a major health care and societal problem that affects millions of people worldwide. In Nigeria, 45,000 to 90,000 babies are born each year with SCD. In the United States, SCD is the most common genetic disorder, affecting more than 80,000 people, the majority of whom are African American. Sickle cell pain is the hallmark feature of SCD. Most of the research on pain from SCD has focused on children with acute pain associated with sickle cell crisis. Consequently, very little is known about the occurrence and characteristics of chronic pain, especially in adults with SCD. Individuals with SCD who experience chronic pain are often underserved, and their pain is undertreated. This undertreatment may result in millions of dollars per year spent on emergency room visits, hospitalizations, and lost work productivity. The primary purpose of this literature review was to summarize the findings from studies that evaluated the characteristics of chronic pain in adults with SCD. Each of the studies included in this review was evaluated to determine if it provided data on the following multidimensional characteristics of chronic pain: occurrence, number of pain episodes, duration, pattern, quality, location, intensity, aggravating factors, relieving factors, and impact of pain on function. A secondary purpose was to identify gaps in knowledge and directions for future research on the multiple dimensions of chronic pain in adults with SCD.

State Medical Board Members' Attitudes About the Legality of Chronic Prescribing to Patients With Noncancer Pain: The Influence of Knowledge and Beliefs About Pain Management, Addiction, and Opioid Prescribing - Corrected Proof

Aaron M. Gilson — 2010-07-26

Abstract: Context: In the United States, physicians' practice is regulated at the state level, with medical board members distinguishing legitimate medical practice from unprofessional conduct. For this process to be effective, regulators should have knowledge and beliefs that conform to current standards of practice and medical understanding. Past research has demonstrated that some board members continue to view the prolonged prescribing of opioid analgesics to treat noncancer pain as being unlawful or unacceptable medical practice, especially when the patient with pain has a history of substance abuse.Objectives: This study was designed to determine whether relevant clinical or policy issues can adequately explain regulators' attitudes about the legality of opioid prescribing for patients with noncancer pain.Methods: A total of 277 questionnaires were obtained from a national sample of medical board members. Using binomial logistic regression procedures, the predictive significance of 12 factors related to four variable domains was explored: 1) beliefs about opioid addiction and diversion, 2) beliefs and knowledge about federal and state policy, 3) clinical beliefs about opioid prescribing, and 4) demographic characteristics.Results: Separate logistic regression models were computed to determine the extent that knowledge and beliefs contribute to attitudes about the legality of chronic opioid therapy for noncancer pain and for noncancer pain with a history of substance abuse. Three variables demonstrated statistical significance in both regression models: 1) characterizing addiction in terms of physiological phenomena, 2) believing regulatory policy is useful to improve pain relief, and 3) incorrectly believing that federal law limits amount of Schedule II medication that can be prescribed at one time. When considering the legality of prescribing opioids for patients with noncancer pain, the following additional factors had a notable influence: Viewing addiction as common when treating pain with opioids (P=0.030), considering it very important for a board to have regulatory policy about pain treatment (P=0.038), doubting the legitimacy of more than one opioid prescription for a single patient (P<0.0001), and being younger (P=0.038). Alternatively, for patients with noncancer pain and a history of abuse, only one other factor was significant: Reporting the adequacy of their training in pain management as “poor” (P=0.012).Conclusions: Study results showed that the parsimonious regression models used in this study reasonably explained such attitudes. Suggestions were offered for achieving more comprehensive insight about the factors that can shape regulators' attitudes about prescribing legality.

Re: NHPCO Position Statement on Palliative Sedation - Corrected Proof

David Muller — 2010-07-26

I thank Timothy Kirk, PhD, and Margaret Mahon, PhD, RN, FAAN, writing for the Palliative Sedation Task Force of the National Hospice and Palliative Care Organization (NHPCO) Ethics Committee, for their article providing clarity on the practice of palliative sedation. As a practitioner, I recognize the importance of eliminating confusion about this practice in the minds of the public and even among medical providers.

The Advanced Dementia Prognostic Tool: A Risk Score to Estimate Survival in Nursing Home Residents with Advanced Dementia - Corrected Proof

2010-07-12

Abstract: Context: Estimating life expectancy is challenging in advanced dementia.Objective: To create a risk score to estimate survival in nursing home (NH) residents with advanced dementia.Methods: This was a retrospective cohort study performed in the setting of all licensed U.S. NHs. Residents with advanced dementia living in U.S. NHs in 2002 were identified using Minimum Data Set (MDS) assessments. Mortality data from Medicare files were used to determine 12-month survival. Independent variables were selected from the MDS. Cox proportional hazards regression was used to model survival. The accuracy of the final model was assessed using the area under the receiver operating characteristic curve (AUROC). To develop a risk score, points were assigned to variables in the final model based on parameter estimates. Residents meeting hospice eligibility guidelines for dementia, based on MDS data, were identified. The AUROC assessed the accuracy of hospice guidelines to predict six-month survival.Results: Over 12 months, 40.6% of residents with advanced dementia (n=22,405) died. Twelve variables best predicted survival: length of stay, age, male, dyspnea, pressure ulcers, total functional dependence, bedfast, insufficient intake, bowel incontinence, body mass index, weight loss, and congestive heart failure. The AUROC for the final model was 0.68. The risk score ranged from 1 to 32.5 points (higher scores indicate worse survival). Only 15.9% of residents met hospice eligibility guidelines for which the AUROC predicting six-month survival was 0.53.Conclusion: A mortality risk score derived from MDS data predicted six-month survival in advanced dementia with moderate accuracy. The predictive ability of hospice guidelines, simulated with MDS data, was poor.

Evaluation of the FICA Tool for Spiritual Assessment - Corrected Proof

Tami Borneman, Betty Ferrell, Christina M. Puchalski — 2010-07-09

Abstract: Context: The National Consensus Project for Quality Palliative Care includes spiritual care as one of the eight clinical practice domains. There are very few standardized spirituality history tools.Objective: The purpose of this pilot study was to test the feasibility for the Faith, Importance and Influence, Community, and Address (FICA) Spiritual History Tool in clinical settings. Correlates between the FICA qualitative data and quality of life (QOL) quantitative data also were examined to provide additional insight into spiritual concerns.Methods: The framework of the FICA tool includes Faith or belief, Importance of spirituality, individual's spiritual Community, and interventions to Address spiritual needs. Patients with solid tumors were recruited from ambulatory clinics of a comprehensive cancer center. Items assessing aspects of spirituality within the Functional Assessment of Cancer Therapy QOL tools were used, and all patients were assessed using the FICA. The sample (n=76) had a mean age of 57, and almost half were of diverse religions.Results: Most patients rated faith or belief as very important in their lives (mean 8.4; 0–10 scale). FICA quantitative ratings and qualitative comments were closely correlated with items from the QOL tools assessing aspects of spirituality.Conclusions: Findings suggest that the FICA tool is a feasible tool for clinical assessment of spirituality. Addressing spiritual needs and concerns in clinical settings is critical in enhancing QOL. Additional use and evaluation by clinicians of the FICA Spiritual Assessment Tool in usual practice settings are needed.

Validation of the Pediatric Functional Assessment of Cancer Therapy Questionnaire (Version 2.0) in Brain Tumor Survivors Aged 13 Years and Older - Corrected Proof

2010-07-09

Abstract: 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.

Using Vital Sign Flow Sheets Can Help to Identify Neoplastic Fever and Other Possible Causes in Oncology Patients: A Retrospective Observational Study - Corrected Proof

2010-07-05

Abstract: Objective: To investigate neoplastic fever (NF) patterns from vital sign flow sheets.Methods: Between September 1997 and February 2009, data on 150 consecutive hospitalized patients with advanced or metastatic solid tumors documented to have NF were retrospectively collected. Sixty patients with sepsis were used as a comparison group.Results: All patients with NF demonstrated intermittent fever patterns. Peak body temperature was 39.0±0.6°C (38.0–40.8°C). Baseline pulse rates in 139 (93%) patients showed no increase except during febrile periods. The remaining 11 (7%) patients had transiently elevated baseline pulse rates at the time of cessation of postchemotherapy dexamethasone. Once-daily fever spike patterns occurred in 108 (72%) patients. Fever spikes were most commonly found at 9 am (42%) and 5 pm (37%). Twice-daily fever spike patterns were noted in the 42 (28%) remaining patients. In the comparison group, baseline pulse rate elevated in all patients during febrile periods and 20 (33%) showed intermittent fever patterns.Conclusion: We conclude that the NF pattern is characterized by intermittent fever without an obvious increase in baseline pulse rate except during febrile periods. Knowing NF patterns from vital sign flow sheets can help identify NF and other possible causes of fever in oncology patients.

Randomized Clinical Trial on the Effects of Adenosine 5'-Triphosphate Infusions on Quality of Life, Functional Status, and Fatigue in Preterminal Cancer Patients - Corrected Proof

2010-07-05

Abstract: Context: One potential agent to improve symptoms and quality of life (QoL) in advanced cancer patients is adenosine 5'-triphosphate (ATP). Several reports suggest that ATP may positively affect QoL and survival in patients with advanced non-small-cell lung cancer.Objectives: To investigate the effects of ATP infusions on QoL parameters in patients with preterminal cancer of mixed tumor types.Methods: Ninety-nine preterminal cancer patients were randomly allocated to receive either ATP intravenously weekly (8–10 hours/week, with maximum 50μg/kg.minute) for eight weeks or receive no ATP (control group). QoL parameters were assessed until eight weeks and analyzed by repeated-measures analysis of covariance.Results: Fifty-one patients were randomized to the ATP group and 48 to the control group. Unexpectedly, in the untreated control group, most of the outcome parameters did not deteriorate but remained stable or even significantly improved over time. Between the ATP and control groups, no statistically significant differences were observed for the large majority of outcome parameters, except for the strength of elbow flexor muscles in favor of the control group.Conclusion: ATP infusions, at the dose and schedule studied, did not have a significant effect on QoL, functional status, or fatigue in preterminal cancer patients of mixed tumor types.

Nonconvulsive Status Epilepticus in Palliative Care Patients - Corrected Proof

2010-07-01

Abstract: Altered mental status and reduced level of consciousness are common among patients admitted to palliative care units. However, nonconvulsive status epilepticus (NCSE) has rarely been considered as a possible cause, and electroencephalographic confirmation of the epileptic status is sparse. The clinical presentation of patients with NCSE varies from altered mental status to coma, with no or only minimal convulsions. We report a prospective evaluation of patients with altered mental status on admission to our palliative care unit in the year 2007. Of 290 patients admitted in 2007, 49 patients showed signs of confusion or delirium and/or a reduction in their level of consciousness. NCSE was suspected clinically in 22 of these patients, and epileptic activity could be confirmed in 15 (5.2%) of 290 patients. Nine of 15 patients could be effectively treated with anticonvulsants and regained communication ability before death. NCSE appears to be an important, often unrecognized, and potentially treatable cause of altered mental status in palliative care patients. Pharmacological treatment might restore communicative abilities even in severely ill patients.

Long-term Safety and Tolerability of Fentanyl Buccal Tablet for the Treatment of Breakthrough Pain in Opioid-Tolerant Patients With Chronic Pain: An 18-Month Study - Corrected Proof

Perry G. Fine, John Messina, Fang Xie, James Rathmell — 2010-07-01

Abstract: Context: 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).Objectives: 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.Methods: This was a long-term, multicenter, open-label safety study that accepted patients naive 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.Results: 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.Conclusion: 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.

Effects of Bereavement Life Review on Spiritual Well-Being and Depression - Corrected Proof

2010-07-01

Abstract: Context: Some bereaved families experience low spiritual well-being, such as lack of meaning of life or purpose and psychological distress like severe depression.Objectives: The primary aim of this study was to investigate the effects of the Bereavement Life Review on the spiritual well-being of bereaved family members. The secondary aim was to investigate the effects of this therapy on depression.Methods: Participants were 21 bereaved family members who lost loved ones in various palliative care units in Japan. They received the Bereavement Life Review, which consisted of two sessions for about 60 minutes each. In the first session, a bereaved family member reviewed memories with a clinical psychologist and answered some question. After the first session, the clinical psychologist made an album. In the second session, the family member and the clinical psychologist confirmed the accuracy of the contents of the album. The duration of the therapy was two weeks. The family member was assessed using the Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being (FACIT-Sp) scale and the Beck Depression Inventory®-II (BDI-II) pre- and postintervention.Results: FACIT-Sp scores increased from 19.9±5.8 to 22.8±5.1 (Z=−2.2, P=0.028 by Wilcoxon signed-rank test) and BDI scores decreased from 10.8±7.7 to 6.8±5.8 (Z=−3.0, P=0.003).Conclusions: The Bereavement Life Review has the potential to improve spiritual well-being and decrease depression of bereaved family members. A further study with more participants is required to confirm the present findings.

Meaning in Life in Palliative Care Patients - Corrected Proof

2010-07-01

Abstract: Context: The construct “meaning in life” (MiL) has recently raised the interest of clinicians working in psycho-oncology and end-of-life care and has become a topic of scientific investigation.Objective: The aim of this study was to compare MiL in palliative care (PC) patients with a representative sample of the German population.Methods: In this cross-sectional study, all PC patients treated in the PC inpatient unit and through the PC consult service at Ludwig-Maximilians-University hospital, Munich, from May 2005 to July 2007 were eligible to participate. Patients were interviewed by a doctoral student, psychologist, or physician, all previously trained to administer the Schedule for Meaning in Life Evaluation (SMiLE) in a standardized way. In the SMiLE, respondents first list individual areas that provide meaning to their life before rating their current level of importance and satisfaction with each area. Overall indices of weighting (IoW, range 20–100), satisfaction (IoS, range 0–100), and weighted satisfaction (IoWS, range 0–100) are calculated.Results: One hundred PC patients completed the SMiLE: the IoS was 70.2±19.7, the IoW was 84.7±11.5, and the IoWS was 72.0±19.4. The representative sample (n=977) scored significantly higher in the IoS (82.8±14.7) and IoWS (83.3±14.8) but not in the IoW (85.6±12.3). Compared with healthy individuals, PC patients are more likely to list partner, friends, leisure, spirituality, well-being, nature/animals, and pleasure as meaningful areas. Examining the satisfaction ratings, it is noteworthy that PC patients' satisfaction scores are fairly high (and not lower than their healthy counterparts') in a number of domains: family, partner, home/garden, spirituality, and finances. On the other hand, they score significantly lower in nature/animals, leisure, friends, well-being, altruism, work, pleasure, and health.Conclusion: These findings underscore the potential of the SMiLE for identifying areas that are particularly important to individuals, and that can be targeted by the PC team to improve overall life satisfaction at the end of life.

In-Clinic Use of Electronic Pain Diaries: Barriers of Implementation Among Pain Physicians - Corrected Proof

2010-06-28

Abstract: Objective: The aim of this study was to examine barriers to the use of electronic diaries within the clinic setting and determine outcome differences between patients who used electronic diaries to monitor their progress with summary data feedback and patients who monitored their progress with paper diaries without summary data feedback.Methods: One hundred thirty-four (n=134) chronic pain patients were asked to monitor their pain, mood, activity interference, medication use, and pain location on either a paper or electronic diary immediately before each monthly clinic visit for 10 months. Patients and their treating physicians in the electronic diary group (n=67) were able to observe changes in their ratings whereas patients using the paper diaries (n=67) had no feedback about their data entry.Results: Most participants believed that completing pain diaries was beneficial; yet, only 23% of patients in the experimental condition felt that the data from the electronic diaries improved their care and less than 15% believed that their doctor made a change in their treatment based on the summary diary information.Conclusion: In general, treating physicians were positive about the use of electronic diaries, although they admitted that they did not regularly incorporate the summary data in their treatment decision making because either they forgot or they were too busy. Future studies in understanding barriers to physicians' and patients' use of diary data to impact treatment outcome are needed to improve care for persons with chronic pain.

The Association of Depression and Pain with Health-Related Quality of Life, Disability, and Health Care Use in Cancer Patients - Corrected Proof

2010-06-28

Abstract: Context: Pain and depression are two of the most prevalent and treatable cancer-related symptoms, each present in at least 20%–30% of oncology patients.Objective: To determine the associations of pain and depression with health-related quality of life (HRQL), disability, and health care use in cancer patients.Methods: The Indiana Cancer Pain and Depression study is a randomized clinical trial comparing telecare management vs. usual care for patients with cancer-related pain and/or clinically significant depression. In this article, baseline data on patients enrolled from 16 urban or rural community-based oncology practices are analyzed to test the associations of pain and depression with HRQL, disability, and health care use.Results: Of the 405 participants, 32% had depression only, 24% pain only, and 44% both depression and pain. The average Hopkins Symptom Checklist 20-item depression score in the 309 depressed participants was 1.64 (on 0–4 scale), and the average Brief Pain Inventory (BPI) severity score in the 274 participants with pain was 5.2 (on 0–10 scale), representing at least moderate levels of symptom severity. Symptom-specific disability was high, with participants reporting an average of 16.8 of the past 28 days (i.e., 60% of their days in the past four weeks) in which they were either confined to bed (5.6 days) or had to reduce their usual activities by 50% (11.2 days) because of pain or depression. Moreover, 176 (43%) participants reported being unable to work because of health-related reasons. Depression and pain had both individual and additive adverse associations with quality of life. Most patients were currently not receiving care from a mental health or pain specialist.Conclusion: Depression and pain are prevalent and disabling across a wide range of types and phases of cancer, commonly co-occur, and have additive adverse effects. Enhanced detection and management of this disabling symptom dyad is warranted.

Propensity for Home Death Among Taiwanese Cancer Decedents in 2001–2006, Determined by Services Received at End of Life - Corrected Proof

2010-06-28

Abstract: Context: 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.Objectives: To investigate factors associated with home death, specifically, services received by cancer patients at the end of life (EOL).Methods: This was a retrospective cohort study using administrative data from 201,201 Taiwanese cancer decedents in the period 2001–2006.Results: 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.Conclusion: 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.

Symptoms in the Month Before Death for Stage 5 Chronic Kidney Disease Patients Managed Without Dialysis - Corrected Proof

2010-06-28

Abstract: Context: There is little evidence on the symptoms experienced by those with advanced (Stage 5) chronic kidney disease (CKD), managed without dialysis, as they approach death. As palliative care extends to noncancer illnesses, understanding symptom prevalence and severity close to death will clarify which symptom interventions are most needed and which elements of (largely cancer driven) models of palliative care best translate into end-of-life care for this population.Objectives: To determine symptom prevalence and severity in the last month of life for patients with Stage 5 CKD, managed without dialysis.Methods: Longitudinal symptom survey in three U.K. renal units, using the patient-completed Memorial Symptom Assessment Scale-Short Form (MSAS-SF). We calculated the prevalence of individual symptoms (with 95% confidence intervals [CI] to reflect sample size), plus MSAS-SF subscales, in the month before death. Comparison is made with previously published data on symptoms in last month of life in advanced cancer, also measured using MSAS-SF.Results: Seventy-four patients (mean age: 81 years; standard deviation [SD]: 6.8) were recruited (response rate: 73%); 49 (66%) died during follow-up (mean age: 81 years; SD: 5.7). “Month before death” symptom data were available for 43 (88%) of the 49 participants who died. Median time of data collection was 18 days from death (interquartile range: 12–26 days). More than half had lack of energy (86%; 95% CI: 73%–94%), itch (84%; 70%–93%), drowsiness (82%; 68%–91%), dyspnea (80%; 66%–90%), poor concentration (76%; 61%–87%), pain (73%; 59%–85%), poor appetite (71%; 57%–83%), swelling arms/legs (71%; 57%–83%), dry mouth (69%; 55%–82%), constipation (65%; 50%–78%), and nausea (59%; 44%–73%). Levels of distress correspond to prevalence, with the exception of dyspnea, which was disproportionately more distressing. The median number of symptoms reported was 16.6 (range: 6–27), rising to 20.4 (range: 7–34) if additional renal symptoms were included. On average, psychological distress was moderate (mean MSAS-PSYCH: 1.55) but with wide variation (SD: 0.50; range: 0.17–2.40), suggesting diverse levels of individual distress. The prevalence of both physical and psychological symptoms and the number reported were higher than those in advanced cancer patients in the month before death.Conclusion: Stage 5 CKD patients have clinically important physical and psychological symptom burdens in the last month of life, similar or greater than those in advanced cancer patients. Symptoms must be addressed through routine symptom assessment, appropriate interventions, and with pertinent models of end-of-life care.

Aberrant Drug-Related Behavior Observed During Clinical Studies Involving Patients Taking Chronic Opioid Therapy for Persistent Pain and Fentanyl Buccal Tablet for Breakthrough Pain - Corrected Proof

Steven D. Passik, John Messina, Anthony Golsorkhi, Fang Xie — 2010-06-28

Abstract: Context: Information on aberrant drug-related behaviors in the clinical study setting is limited.Objectives: This retrospective analysis was designed to identify the types and frequency of aberrant drug-related behaviors (including misuse and abuse) and associated patient characteristics in opioid-tolerant patients with chronic pain.Methods: Data from opioid-tolerant patients participating in clinical studies of fentanyl buccal tablet (FBT) for breakthrough pain (up to 18 months of clinical study case-report forms) were retrospectively reviewed and coded for abuse, overdose, and aberrant behavior. Aberrant behaviors were categorized as those involving FBT (overuse, lost or stolen study drug) and those not involving FBT (patients seeking prescriptions from other sources, not returning for follow-up).Results: Of the 1,160 patients evaluated, 10 (<1%) patients had an abuse-related event, 18 (<2%) had a positive urine drug screening (nonprescribed drug or illicit substance), and 12 (1%) had an event consistent with opioid overdose; 124 (11%) had aberrant behaviors related to FBT, and 68 (6%) had aberrant behaviors that were not. Aberrant behaviors were more frequent in men (odds ratio [OR]: 1.5; 95% confidence interval [CI]: 1.1, 2.1; P<0.01), in patients 42 years or younger (OR: 2.5; 95% CI: 1.6, 4.0; P<0.01), and in patients 43 years to 49 years (OR: 1.9; 95% CI: 1.2, 3.1; P<0.01).Conclusion: The incidence of drug abuse events and aberrant drug-related behaviors was relatively low, probably because of the implementation of universal precautions and the controlled clinical study setting. Even in this setting, events occurred, highlighting the limits of screening and the need for ongoing monitoring of aberrant behavior.

Does Recall Period Have an Effect on Cancer Patients' Ratings of the Severity of Multiple Symptoms? - Corrected Proof

2010-06-25

Abstract: Context: Choosing an appropriate recall period for symptom assessment in a clinical trial is dependent on the design and purpose of the trial.Objective: To examine the effects of recall on symptom severity ratings by comparing ratings made using 24 hour and seven day recall periods of the MD Anderson Symptom Inventory (MDASI).Methods: Forty-two patients in their third to eighth week of chemoradiation rated their symptoms using the MDASI on two separate occasions (T1 and T2), one week apart. At T1, patients were randomly assigned to rate symptoms using either a 24 hour or a seven day recall. At T2, patients rated symptoms using the recall period not used at their first visit.Results: Comparing the 24 hour and seven day recall periods, the correlation coefficient for total symptom severity was 0.888. All correlation coefficients for symptom severity items were >0.7 except for distress (r=0.67). The percentages of moderate to severe symptoms (rated ≥5) were consistent for both recall periods, with no significant difference between recall periods in the prevalence of moderate to severe symptoms. Cronbach α coefficients for both 24 hour and seven day recalls were >0.8. Symptoms from both recall periods were more severe for patients with poorer performance status. Twenty patients were cognitively debriefed; 70% thought that the seven day recall was “more appropriate” for the MDASI, but 85% did not think that recall period would influence their answers.Conclusion: This study demonstrated that the MDASI in a seven day recall format has psychometric properties consistent with the 24 hour recall version, which may promote its use in future cancer clinical trials and may inform the choice of recall period when symptoms are outcome measures.

An Analysis of Heavy Utilizers of Opioids for Chronic Noncancer Pain in the TROUP Study - Corrected Proof

2010-06-25

Abstract: Context: Although opioids are increasingly used for chronic noncancer pain (CNCP), we know little about opioid dosing patterns among individuals with CNCP in usual care settings, and how these are changing over time.Objectives: To investigate the distribution of mean daily dose and mean days supply among patients with CNCP in two disparate populations, one national and commercially insured population (HealthCore) and one state based and publicly insured (Arkansas Medicaid), for years 2000 and 2005.Methods: For individuals with any opioid use, we calculated the distribution of mean daily dose (in milligram morphine equivalents), mean days supply in a year, mean annual dose, and patient characteristics associated with heavy utilizers of opioids.Results: Between 2000 and 2005, across all percentiles, there was little change in the mean daily opioid dose. In HealthCore, mean days supply increased most rapidly at the top end of the days supply distribution, whereas in Arkansas Medicaid, the greatest increases were near the median of days supply. In HealthCore, the top 5% of users accounted for 70% of total use (measured in milligram morphine equivalents), and the top 5% of Arkansas Medicaid users accounted for 48% of total use. The likelihood of heavy opioid utilization was increased among individuals with multiple pain conditions, and in HealthCore, among those with mental health and substance use disorders.Conclusion: Opioid use is heavily concentrated among a small percent of patients. The characteristics of these high utilizers need to be further established, and the benefits and risks of their treatment evaluated.

Hope in the Context of Lung Cancer: Relationships of Hope to Symptoms and Psychological Distress - Corrected Proof

2010-06-25

Abstract: Context: Hope may be important in explaining the variability in how patients adjust to lung cancer.Objective: The aim of this study was to examine how hope, as conceptualized by Snyder et al., is associated with multiple indices of adjustment to lung cancer. This theoretical model of hope suggests that people with high levels of hope are able to think about the pathways to goals (pathways) and feel confident that they can pursue those pathways to reach their goals (agency).Methods: We hypothesized that higher levels of hope, as measured by Snyder et al.'s hope scale, would be related to lower levels of pain and other lung cancer symptoms (i.e., fatigue and cough) and lower psychological distress (i.e., depression). Participants in this study included patients with a diagnosis of lung cancer (n=51). All participants provided demographic and medical information and completed measures of hope, lung cancer symptoms, and psychological distress.Results: Data analyses found that hope was inversely associated with major symptoms of cancer (i.e., pain, fatigue, and cough) and psychological distress (i.e., depression), even after accounting for important demographic and medical variables (i.e., age and cancer stage).Conclusion: The findings of this cross-sectional study highlight the potential importance of hope in understanding adjustment to lung cancer. Future longitudinal research could help reveal how hope and adjustment interact over the course of cancer survivorship.

Validation of the Patient Care Monitor (Version 2.0): A Review of System Assessment Instrument for Cancer Patients - Corrected Proof

2010-06-25

Abstract: Context: 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.Objective: To validate and test the PCM 2.0 in three cancer populations.Methods: 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), M.D. Anderson Symptom Inventory (MDASI), and 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.Results: 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.Conclusion: 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.

The Costs of Treating Terminal Patients - Corrected Proof

2010-06-25

Abstract: Context: In addition to the effectiveness of terminal care, policy makers and health care payers are concerned about the costs of treating terminal patients in a context of spiraling health care costs and limited resources.Objectives: This article aims to review the international literature on the costs of treating terminal patients.Methods: Studies were identified by searching PubMed, Centre for Reviews and Dissemination databases, Cochrane Database, and EconLit, up to April 2009. Studies were included that contrasted costs in different health care settings and that compared palliative care with alternative therapeutic approaches for terminal patients.Results: The few studies that focused on treatment of terminal patients across health care settings showed that hospitalization costs represent the principal component of palliative care costs. In the hospital setting, palliative care tends to be cheaper than usual care or care delivered in units other than the palliative care unit. Palliative care costs depend on patient characteristics, such as diagnosis, status of disease, and age. Also, different care models appear to target different patient groups and offer varied packages of services. Finally, there is some evidence pointing to cost advantages of palliative care at home as compared with alternative care models, although this needs to be corroborated by further research.Conclusion: Different approaches to deliver palliative care are not substitutes of each other and, thus, have different costs. From a cost perspective, hospitals need to pay attention to admitting patients to the palliative care unit at the right time.

An Exploratory Study on the Effects of an Expectancy Manipulation on Chemotherapy-Related Nausea - Corrected Proof

2010-06-25

Abstract: Context: Previous research has shown that the effectiveness of acupressure bands in reducing chemotherapy-related nausea is related to patients' expectations of efficacy.Objective: To test whether an informational manipulation designed to increase expectation of efficacy regarding acupressure bands would enhance their effectiveness.Methods: We conducted an exploratory four-arm randomized clinical trial in breast cancer patients about to begin chemotherapy. All patients received acupressure bands and a relaxation CD. This report focuses on Arm 1(expectancy-neutral informational handout and CD) compared with Arm 4 (expectancy-enhancing handout and CD). Randomization was stratified according to the patient's level of certainty that she would have treatment-induced nausea (two levels: high and low). Experience of nausea and use of antiemetics were assessed with a five-day diary.Results: Our expectancy-enhancing manipulation resulted in improved control of nausea in the 26 patients with high nausea expectancies but lessened control of nausea in 27 patients having low nausea expectancies. This interaction effect (between expected nausea and intervention effectiveness) approached statistical significance for our analysis of average nausea (P=0.084) and reached statistical significance for our analysis of peak nausea (P=0.030). Patients receiving the expectancy-enhancing manipulation took fewer antiemetic pills outside the clinic (meanenhanced=12.6; meanneutral=18.5, P=0.003).Conclusion: This exploratory intervention reduced antiemetic use overall and also reduced nausea in patients who had high levels of expected nausea. Interestingly, it increased nausea in patients who had low expectancies for nausea. Confirmatory research is warranted.

Pain in Ehlers-Danlos Syndrome Is Common, Severe, and Associated with Functional Impairment - Corrected Proof

Nicol C. Voermans, Hans Knoop, Gijs Bleijenberg, Baziel G. van Engelen — 2010-06-25

Abstract: Objectives: The Ehlers-Danlos Syndrome (EDS) is a clinically and genetically heterogeneous group of heritable connective tissue disorders characterized by joint hypermobility, skin hyperextensibility, and tissue fragility. Musculoskeletal pain is mentioned in the diagnostic criteria and described as early in onset, chronic, and debilitating. However, systematic research on pain in EDS is scarce. Therefore, we investigated prevalence and impact of pain and associated features in a large group of EDS patients.Methods: We performed a study among members of the Dutch EDS patient organization (n=273) and included the McGill Pain Questionnaire to investigate various aspects of pain, the Sickness Impact Profile to study functional impairment, the Symptom Checklist subscale sleep to evaluate sleep disturbances, and the Checklist Individual Strength subscale fatigue to determine fatigue severity.Results: The results of this study show that 1) chronic pain in EDS is highly prevalent and associated with regular use of analgesics; 2) pain is more prevalent and more severe in the hypermobility type than in the classic type; 3) pain severity is correlated with hypermobility, dislocations, and previous surgery; 4) pain is correlated with low nocturnal sleep quality; and 5) pain contributes to functional impairment in daily life, independently of the level of fatigue.Conclusion: From this large cohort of EDS patients, we conclude that pain is common and severe in EDS. Pain is related to hypermobility, dislocations, and previous surgery and associated with moderate to severe impairment in daily functioning. Therefore, treatment of pain should be a prominent aspect of symptomatic management of EDS.

Sources of Emotional Distress Associated with Diarrhea Among Late Middle-Age and Older HIV-Infected Adults - Corrected Proof

2010-06-25

Abstract: Although the experience of physical symptoms can adversely influence emotional well-being, the specific emotional reactions experienced in response to specific symptoms are not well understood. The current report examines the emotional impact of diarrhea among HIV-positive late middle-age and older adults (i.e., age 50 years and older). In-depth interviews were conducted with 100 participants, of whom 29 had experienced diarrhea and spoke about the emotional impact it had had on them. Three principal themes emerged: 1) I don't control the diarrhea, the diarrhea controls me; 2) I feel ashamed, dirty, and tainted; and 3) I fear what the diarrhea is doing to me and what it means. Their inability to control when and where their diarrhea would occur was a great source of emotional distress for participants. Almost all feared the possibility of fecal incontinence while out in public and the humiliation it would bring. To avoid this, many greatly restricted their time outside the home or where they would go to ensure access to a restroom. Others felt shame and perpetually “dirty” even when not dealing with a bout of diarrhea. Many also worried about the effect the diarrhea would have on their health and whether it signaled progression to end-stage disease. The data strongly support the need to aggressively manage diarrhea in HIV-infected adults as the social and emotional consequences can be profound. When it cannot be effectively controlled, physicians and social service agencies should address the isolation by providing home-based opportunities for social support and interaction.

Efficacy of an Intervention for Fatigue and Sleep Disturbance During Cancer Chemotherapy - Corrected Proof

2010-06-21

Abstract: Context: Multiple complex symptoms from cancer treatment can interfere with functioning.Objectives: To evaluate the efficacy of an “energy and sleep enhancement” (EASE) intervention to relieve fatigue and sleep disturbance and improve health-related functional status.Methods: Individuals receiving chemotherapy (CTX) were randomized to the EASE (n=153) or a control intervention (n=139). The EASE intervention included information and behavioral skills taught by an oncology nurse in three telephone sessions. The primary outcomes of fatigue, sleep disturbance, and functional status were measured before CTX, Day 4 after first treatment (baseline), and 43–46 or 57–60 days later (follow-up), depending on the CTX cycle length.Results: The sample was primarily female (82%) and non-Hispanic white (89%), with mean age of 53.9 years. Fatigue and patient-reported sleep disturbance were elevated in both groups at baseline and follow-up. Actigraphy revealed that the total sleep time was almost eight hours, and sleep percent was greater than 85% for both groups at both time points (normal range). Physical functioning was diminished and at the same level as a sample with serious illness. Mental functioning was in normal range. A repeated-measures analysis of variance revealed no statistically significant group-by-time effects for fatigue, sleep disturbance, or functional status. Unemployed individuals showed greater benefit from the EASE intervention, reporting less pain and symptom interference.Conclusion: Potential explanations include high variability and/or floor effect for fatigue, incorrect timing of measures, insufficient amount or dose of the intervention, and confounding effects of gender. Future research should consider screening for symptom severity and tailoring interventions.

Clinical Trials Focusing on Cancer Pain Educational Interventions: Core Components to Include During Planning and Reporting - Corrected Proof

Carla R. Stiles, Patricia D. Biondo, Greta Cummings, Neil A. Hagen — 2010-06-14

Abstract: Context: Robust recommendations on the reporting of methods and results of clinical trials such as therapeutic intervention trials are widely used, such as the Consolidated Standards of Reporting Trials (CONSORT) recommendation. There has not been agreement on analogous publication standards for educational intervention trials, making interpretation of educational intervention studies difficult.Objective: The purpose of this report is to describe common deficiencies in reporting of educational intervention trials for cancer pain control, and to offer suggestions for authors to consider as they plan their studies, and report and publish research findings for educational interventions that use randomized controlled trials and other educational trial methodologies.Methods: A systematic review of published knowledge translation intervention trials intended to improve cancer pain was undertaken, of which most were educational interventions.Results: Many educational intervention clinical trials designed to improve management of cancer pain appeared methodologically weak, and their results were more difficult to interpret because of reporting deficiencies. In the course of the review, patterns of deficiencies in reporting of methods and trial results were documented. Deficiencies in reporting were compared with the CONSORT recommendations for reporting clinical trials, and parallel recommendations were drafted for educational intervention trials. Patterns of deficiency in reporting cancer pain educational intervention trials were synthesized into seven domains, generically applicable to a range of study designs. Draft recommendations intended to address these deficiencies were constructed to improve communication of educational research results.Conclusion: Development of a standardized reporting template for clinical trials in cancer pain educational interventions could advance knowledge transfer research and thereby increase effectiveness of national and international cancer control policy designed to support cancer pain control.

Content and Spiritual Items of Quality-of-Life Instruments Appropriate for Use in Palliative Care: A Review - Corrected Proof

2010-06-14

Abstract: Despite the importance of palliative care and quality of life (QoL) as an outcome measure, little research evaluated the QoL instruments that are used in end-of-life situations. We evaluated the content of and domains measured by QoL instruments that are suitable for use in palliative care and how the domain of spirituality was operationalized in these instruments. We conducted two literature reviews. One identified the domains that are most important for the QoL of incurably ill patients and resulted in a framework of QoL domains. The other review identified 29 instruments measuring (at least one domain of) QoL that are appropriate for use in palliative care. Most of the instruments covered only one or two QoL domains, and none of the instruments covered all QoL domains included in the framework. Among the 29 instruments, 15 included items on spirituality. We also categorized the spirituality items contained in the instruments into the spirituality aspects in the framework. Most spirituality items concerned the meaning or purpose of life. This study provides information about the domains-included QoL instruments that are suitable for use in palliative care and provides insights into the differences in content, which can be helpful when choosing an instrument for use in palliative care.

Exploring the Meaning of Chronic Rejection After Lung Transplantation and Its Impact on Clinical Management and Caregiving - Corrected Proof

2010-06-14

Abstract: Although the literature continues to portray chronic rejection after lung transplantation as ominous with no known treatment, no studies have examined family and clinician caregivers' perceptions of the diagnosis of chronic rejection and its impact on the course of clinical care. We explored the meaning and impact of chronic rejection from the perspective of family (n=10) and clinician (n=3) caregivers. We found that family caregivers considered the onset of chronic rejection to be inevitable, irreversible, unpredictable, and going back to pretransplant. Clinicians considered chronic rejection as a harbinger of deterioration and peril and expressed trepidation about informing recipients and their family caregivers about the diagnosis. Despite the heightened caregiving duties and challenges of treating chronic rejection, its unpredictable course and the prospect of retransplant instilled hope for stabilization or cure among most clinicians and caregivers, leading them to support recipients' wishes to pursue potentially futile treatments. Until recipients were no longer competent, caregivers believed all treatment options (including retransplant) had been exhausted, or suffering was prolonged, caregivers were reluctant to halt extraordinary treatment measures. Caregivers perceived that certainty regarding poor prognosis was required for palliative care and that palliative care was end-of-life care. Consequently, trials of aggressive treatment typically precluded palliative care.

Self-Perceived Burden in Terminally Ill Cancer Patients: A Categorization of Care Strategies Based on Bereaved Family Members' Perspectives - Corrected Proof

2010-06-14

Abstract: Context: Terminally ill cancer patients often experience a self-perceived burden that affects their quality of life; however, no standard care strategy for coping with this form of suffering has ever been established.Objectives: The objectives of this present study were 1) to investigate the prevalence of self-perceived burden among terminally ill cancer patients based on a survey of family members, 2) to assess the level of family perceived usefulness of expert-recommended care strategies, and 3) to categorize the care strategies.Methods: The subjects were bereaved family members of patients who had died in certified palliative care units throughout Japan. The Good Death Inventory was used to evaluate patients' self-perceived burden based on the proxy ratings of family members. The perceived usefulness of care was assessed using a 27-item questionnaire developed by a focus group of palliative experts and a systematic review.Results: A total of 429 responses (64%) received from a member of each of 666 bereaved families were analyzed. In their responses, 25% of the bereaved family members reported that the patient had experienced a mild self-perceived burden, whereas 25% reported that the patient had experienced a moderate to severe self-perceived burden. The family members recommended the following as particularly effective care strategies: “Eliminate pain and other symptoms that restrict patient activity (53%);” “Quickly dispose of urine and stools so that they are out of sight (52%);” and “Support patients' efforts to care for themselves (45%).” A factor analysis showed that the expert-recommended care strategies could be categorized into seven different components.Conclusion: Many terminally ill cancer patients suffer from a self-perceived burden. Family members recommended a variety of care strategies to alleviate patient-perceived burden. Palliative care specialists should have adequate knowledge of promising care strategies for alleviating patient-perceived burden.

Age-Associated Differences in Fatigue Among Patients with Cancer - Corrected Proof

2010-06-14

Abstract: Context: There has been some suggestion that the fatigue experienced by older cancer patients is more severe than that of younger cohorts; however, there is little empirical evidence to support this claim.Objective: The goal of the present study was to determine the differential impact of age and cancer diagnosis on ratings of fatigue using a validated self-report instrument.Methods: The Functional Assessment of Chronic Illness Therapy-Fatigue subscale consists of 13 items measuring fatigue experience and its impact on daily life, with scores ranging from 0 (severe fatigue) to 52 (no fatigue). Fatigue data were available from the U.S. general population (n=1075; 51.3% female, 45.9±16.5 years) and a sample of mixed-diagnosis cancer patients (n=738; 64.3% female, 58.7±13.6 years). General population participants were recruited using an Internet-based survey panel; patients with cancer were recruited from Chicago-area oncology clinics.Results: On average, the cancer patient group reported more severe fatigue than the general population group (36.9 vs. 46.6; F[1,1797]=271.95, P<0.001). There was evidence for increased fatigue with age (F[6,719]=2.56, P<0.02) among patients with cancer, but not in the general population (P=0.06). Furthermore, the group×age interaction was not significant (P=0.44). Hemoglobin (Hgb) was treated as a covariate for 430 patients with available data; there was no main effect for age in this analysis.Conclusion: Older adults, whether they had a cancer diagnosis, reported more fatigue than younger adults. These differences may be explained, in part, by Hgb level. Future research would be helpful to explore longitudinal changes in fatigue in the general population and guide fatigue management for the older cancer patient.

Sublingual Atropine Drops for the Treatment of Pediatric Sialorrhea - Corrected Proof

Adam Rapoport — 2010-06-14

Abstract: Excess oral secretions or sialorrhea is a common problem affecting children and adults with neurological disorders, as well as those approaching the end of life because of a variety of underlying illnesses. Systemic anticholinergic medications are often prescribed in an attempt to improve quality of life and reduce complications; yet, response rates are variable, and a sizable proportion of patients discontinue these drugs as a result of intolerable side effects. This report describes the successful use of a local treatment, sublingually delivered ophthalmic atropine drops, to reduce sialorrhea in a child receiving palliative care. In addition, medical evidence for the safety and efficacy of traditionally prescribed systemic medications for the treatment of pediatric sialorrhea is reviewed.

Determinants of Patient-Family Caregiver Congruence on Preferred Place of Death in Taiwan - Corrected Proof

Siew Tzuh Tang, Cheryl Chia-Hui Chen, Woung-Ru Tang, Tsang-Wu Liu — 2010-06-14

Abstract: Context: Patient-family caregiver congruence on preferred place of death not only increases the likelihood of dying at home but also contributes significantly to terminally ill cancer patients' quality of life.Objective: To examine the determinants of patient-family caregiver congruence on the preferred place of death in Taiwan.Methods: Patient-family caregiver dyads (n=1,108) were surveyed on preferences and needs for end-of-life (EOL) care. Determinants of congruence on preferences were identified by multivariate logistic regression.Results: Patient-caregiver dyads achieved 78.1% agreement on the preferred place of death. The kappa coefficient of congruence was 0.55 (95% confidence interval [CI]=0.50, 0.60). The extent of patient-family caregiver congruence on preferred place of death increased with the patient's higher functional dependence (adjusted odds ratio [AOR] and 95% CI=1.04 [1.02, 1.05]), higher patient-rated importance for dying at preferred place of death (AOR [95% CI]=1.60 [1.43, 1.79]), and having a spousal caregiver (AOR [95% CI]=1.62 [1.14, 2.31]). Other determinants of patient-family caregiver congruence included patient age (AOR [95% CI]=1.01 [1.00, 1.03]), patient-family concordance on preferred EOL care options (AOR=1.68–1.73), patient knowledge of prognosis (AOR [95% CI]=0.68 [0.48, 0.97]), and impact of caregiving on the family caregiver's life (AOR [95% CI]=0.98 [0.96, 0.99]).Conclusion: Increasing patient-family congruence on preferred place of death not only requires knowledge of the patient's prognosis and advance planning by both parties but also depends on family caregivers endorsing patient preferences for EOL care options and ensuring that supporting patients dying at home does not create an intolerable burden for family caregivers.

A Randomized, Double-Blind, Double-Dummy Comparison of the Efficacy and Tolerability of Low-Dose Transdermal Buprenorphine (BuTrans® Seven-Day Patches) With Buprenorphine Sublingual Tablets (Temgesic®) in Patients With Osteoarthritis Pain - Corrected Proof

Ian G.V. James, Catherine M. O'Brien, Chris J. McDonald — 2010-06-14

Abstract: Context: Osteoarthritis (OA) is a common cause of chronic pain, particularly in the older population. Modern approaches to the management of OA pain recommend tailoring treatment to the individual. This study examines treatment options for OA pain in the form of low-dose transdermal and sublingual opioid analgesia.Objectives: The aims of this trial were to compare the efficacy and tolerability of seven-day, low-dose transdermal buprenorphine patches (BuTrans®, Napp Pharmaceuticals Limited UK) with sublingual buprenorphine (Temgesic®, Schering-Plough Limited UK) in patients with moderate to severe pain caused by OA of the hip(s) and/or knee(s), and to establish analgesic equivalence of the two products.Methods: Two hundred forty-six patients with OA pain in the hip(s) and/or knee(s) were enrolled in this randomized, double-blind, parallel-group study; 110 completed the study. Patients were randomized to receive transdermal buprenorphine patches (5, 10, and 20μg/hour) or sublingual buprenorphine (200 and 400 μg tablets). Their medication was titrated to pain control and they were treated for up to seven weeks. The main outcome measures were pain intensity (primary outcome), sleep disturbance, quality of life, and safety assessments.Results: Patients' Box Scale-11 pain scores decreased between entry and assessment in both treatment groups. During the 28-day assessment period, the estimated mean treatment differences (95% confidence intervals) were 0.00 (−0.68,0.69), −0.11 (−0.85,0.63), and −0.13 (−0.95,0.68), for the morning, midday, and evening scores, respectively. All the confidence intervals were within the prespecified limits for equivalence (−1.5, 1.5). Use of escape medication was low. In both treatment groups, sleep disturbance caused by pain decreased between entry and assessment. Patients' quality of life improved during the study. Significantly fewer patients receiving the transdermal buprenorphine patches reported nausea (P=0.035), dizziness (P=0.026), and vomiting (P=0.039).Conclusion: In conclusion, seven-day, low-dose transdermal buprenorphine patches are as effective as sublingual buprenorphine, with a better tolerability profile.

Three Patients With Cancer Who Developed Rapid-Eye-Movement Sleep Behavior Disorder - Corrected Proof

2010-06-14

Abstract: This article discusses the clinical significance of differentiating parasomnia, such as rapid-eye-movement (REM) sleep behavior disorder (RBD), from delirium in patients with advanced cancer. We describe three patients with advanced cancer who presented with aberrant behavior at night. All three patients developed violent behaviors when they were administered opioids and/or chemotherapy. Polysomnography (PSG) showed REM sleep with tonic electromyography. Previous treatment with neuroleptics had failed to improve their problematic behaviors. Diagnosis was made using criteria for REM behavior disorder of the International Classification of Sleep Disorders, 2nd edition, and PSG. Clonazepam (0.5mg/day) was administered orally once at night. After treatment with clonazepam, aberrant and violent behaviors were improved. It should be noted that it is not rare for patients with advanced cancer to present with parasomnia, such as RBD, although organic brain syndrome, such as delirium, is more prevalent. Therefore, it is necessary to provide adequate assessment and treatment of aberrant behaviors in cancer patients.

Preliminary Evidence of an Association Between a Functional Interleukin-6 Polymorphism and Fatigue and Sleep Disturbance in Oncology Patients and Their Family Caregivers - Corrected Proof

2010-06-07

Abstract: Context: Fatigue and sleep disturbance are common problems in oncology patients and their family caregivers (FCs). However, little is known about factors that contribute to interindividual variability in these symptoms or to their underlying biologic mechanisms.Objectives: An evaluation was done on whether genetic variation in a prominent proinflammatory cytokine, interleukin-6 (IL-6 c.-6101A>T [rs4719714]), was associated with mean ratings of evening fatigue, morning fatigue, and sleep disturbance, as well as with the trajectories of these symptoms.Methods: Over six months, participants completed standardized measures of fatigue and sleep disturbance. Linear regression was used to assess the effect of the IL-6 genotype and other covariates on mean fatigue and sleep disturbance scores. Hierarchical linear modeling was used to determine the effect of IL-6 genotype on symptom trajectories.Results: Common allele homozygotes reported higher levels of evening fatigue (P=0.003), morning fatigue (P=0.09), and sleep disturbance (P=0.003) than minor allele carriers. Predictors of baseline level and trajectories of evening fatigue included age, gender, and genotype (intercepts) and baseline level of evening fatigue (slope). Predictors of baseline level and trajectories of morning fatigue included age and genotype (intercept) and age and baseline level of morning fatigue (slope). Predictors of baseline level and trajectories of sleep disturbance included age and genotype (intercept) and baseline level of sleep disturbance (slope).Conclusions: Findings provide preliminary evidence of a genetic association between a functional promoter polymorphism in the IL-6 gene and severity of evening fatigue, morning fatigue, and sleep disturbance in oncology patients and their FCs.

Breakthrough Pain in Oncology: A Longitudinal Study - Corrected Proof

2010-05-06

Abstract: Context: Existing studies on breakthrough pain (BP) have reported different prevalence rates because of different settings, populations, and assessment methods. These studies have used cross-sectional designs, and the relationship of BP with analgesic treatment has not been evaluated.Objective: The aim of this study was to longitudinally assess BP in cancer patients admitted to oncology units.Methods: A consecutive sample of patients admitted to oncology centers was selected. At admission (T0), three months after admission (T3), and six months after admission (T6) data on background pain and BP were recorded. BP was assessed in terms of its intensity, duration, number of episodes, onset with movement, spontaneous relief after stopping activity, limitation of physical activity, and effectiveness of analgesics.Results: Three hundred two patients completed the study. At T0, T3, and T6, 39%, 38%, and 33% patients, respectively, had continuous pain (P=0.294). Pain intensity significantly decreased (P=0.004 and 0.027 at T3 and T6, respectively). Most patients had BP at T0 (87.1%), T3 (80.9%), and T6 (73.2%), and there was a significant decrease in the prevalence of BP over time (P=0.016). Of 149 patients with BP, pain on movement was recorded in 43.6%, 43.4%, and 32.4% at T0, T3, and T6, respectively (P=0.228). Pain spontaneously decreased or ceased when stopping physical activity in 66%, 56%, and 62% at T0, T3, and T6, respectively (P=0.537). Pain on movement strongly limited physical activity in most patients.Conclusion: These data expand current information about BP and underline the need for a longitudinal assessment of a phenomenon that is invariably dependent on stage of disease, patient, and therapeutic factors.