Donna S. Zhukovsky

Unmet Analgesic Needs in Cancer Patients

This study was designed to characterize unmet analgesic needs in a group of cancer patients. One hundred one inpatients were surveyed to document pain prevalence and intensity, satisfaction with pain control and factors associated with unmet analgesic needs during the week prior to admission. Forty-four percent had unmet analgesic needs, defined as pain of moderate or greater than moderate intensity. These patients had a significantly greater prevalence of bone and axillary node involvement, higher than pain intensity, and less satisfaction with pain control. Fifty-nine percent were satisfied with pain control. Dissatisfaction was associated with higher usual pain intensity, less satisfaction with physician information about pain etiology, less frequent attribution of pain to disease, sharp pain, constant and intermittent pain, patient perceptions of less physician concern about pain, patient and physician belief that the patient is receiving insufficient analgesic, and patient wanting more control over analgesic regimen. Patients may benefit from improved treatment of specific syndromes and by attention to communication.

The Human Side of Cancer: By Jimmie C. Holland and Sheldon Lewis Published by HarperCollins, New York, USA, 2000 340 pages,

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Importance The use of benzodiazepines to control agitation in delirium in the last days of life is controversial. Objective To compare the effect of lorazepam vs placebo as an adjuvant to haloperidol for persistent agitation in patients with delirium in the setting of advanced cancer. Design, Setting, and Participants Single-center, double-blind, parallel-group, randomized clinical trial conducted at an acute palliative care unit at MD Anderson Cancer Center, Texas, enrolling 93 patients with advanced cancer and agitated delirium despite scheduled haloperidol from February 11, 2014, to June 30, 2016, with data collection completed in October 2016. Interventions Lorazepam (3 mg) intravenously (n = 47) or placebo (n = 43) in addition to haloperidol (2 mg) intravenously upon the onset of an agitation episode. Main Outcomes and Measures The primary outcome was change in Richmond Agitation-Sedation Scale (RASS) score (range, −5 [unarousable] to 4 [very agitated or combative]) from baseline to 8 hours after treatment administration. Secondary end points were rescue neuroleptic use, delirium recall, comfort (perceived by caregivers and nurses), communication capacity, delirium severity, adverse effects, discharge outcomes, and overall survival. Results Among 90 randomized patients (mean age, 62 years; women, 42 [47%]), 58 (64%) received the study medication and 52 (90%) completed the trial. Lorazepam + haloperidol resulted in a significantly greater reduction of RASS score at 8 hours (−4.1 points) than placebo + haloperidol (−2.3 points) (mean difference, −1.9 points [95% CI, −2.8 to −0.9]; P < .001). The lorazepam + haloperidol group required less median rescue neuroleptics (2.0 mg) than the placebo + haloperidol group (4.0 mg) (median difference, −1.0 mg [95% CI, −2.0 to 0]; P = .009) and was perceived to be more comfortable by both blinded caregivers and nurses (caregivers: 84% for the lorazepam + haloperidol group vs 37% for the placebo + haloperidol group; mean difference, 47% [95% CI, 14% to 73%], P = .007; nurses: 77% for the lorazepam + haloperidol group vs 30% for the placebo + haloperidol group; mean difference, 47% [95% CI, 17% to 71%], P = .005). No significant between-group differences were found in delirium-related distress and survival. The most common adverse effect was hypokinesia (3 patients in the lorazepam + haloperidol group [19%] and 4 patients in the placebo + haloperidol group [27%]). Conclusions and Relevance In this preliminary trial of hospitalized patients with agitated delirium in the setting of advanced cancer, the addition of lorazepam to haloperidol compared with haloperidol alone resulted in a significantly greater reduction in agitation at 8 hours. Further research is needed to assess generalizability and adverse effects. Trial Registration clinicaltrials.gov Identifier: NCT01949662

Effect of Lorazepam With Haloperidol vs Haloperidol Alone on Agitated Delirium in Patients With Advanced Cancer Receiving Palliative Care: A Randomized Clinical Trial

Background: Limited information is available on the symptomatic complications that occur in the last days of life. Aim: We documented the frequency, clinical course, and survival for 25 symptomatic complications among patients admitted to acute palliative care units. Design: Prospective longitudinal observational study. Measurements: Their attending physician completed a daily structured assessment of symptomatic complications from admission to discharge or death. Setting/participants: We enrolled consecutive advanced cancer patients admitted to acute palliative care units at MD Anderson Cancer Center, USA, and Barretos Cancer Hospital, Brazil. Results: A total of 352 patients were enrolled (MD Anderson Cancer Center = 151, Barretos Cancer Hospital = 201). Delirium, pneumonia, and bowel obstruction were the most common complications, occurring in 43%, 20%, and 16% of patients on admission, and 70%, 46%, and 35% during the entire acute palliative care unit stay, respectively. Symptomatic improvement for delirium (36/246, 15%), pneumonia (52/161, 32%), and bowel obstruction (41/124, 33%) was low. Survival analysis revealed that delirium (p < 0.001), pneumonia (p = 0.003), peritonitis (p = 0.03), metabolic acidosis (p < 0.001), and upper gastrointestinal bleed (p = 0.03) were associated with worse survival. Greater number of symptomatic complications on admission was also associated with poorer survival (p < 0.001). Conclusion: Symptomatic complications were common in cancer patients admitted to acute palliative care units, often do not resolve completely, and were associated with a poor prognosis despite active medical management.

Acute symptomatic complications among patients with advanced cancer admitted to acute palliative care units: A prospective observational study

CONTEXT The difference in patient-reported outcomes between study arms can often be difficult to ascertain in randomized controlled trials (RCTs) using a parallel design because of wide interindividual variations in baseline characteristics and how patients interpret the outcome measures. Furthermore, the minimal clinically significant difference is often not available for many outcomes, and even when available, not individualized for each patient. Crossover RCTs are designed for intraindividual comparisons, which can address these issues by asking patients to directly compare the interventions with regard to effectiveness, adverse effects, and ease of use and to provide an overall choice. OBJECTIVES We discuss the key design elements for crossover trials, their advantages and disadvantages relative to parallel designs, and their utility in palliative care research using a number of case examples. METHODS This is a narrative review. RESULTS Crossover studies randomize patients to a sequence of treatments. In addition to facilitating intraindividual comparisons, they often require a smaller sample size for the same statistical power compared with parallel designs and are thus less costly. However, crossover studies are only feasible when the condition being studied is relatively stable and the intervention has a short-term effect. Crossover studies with inadequate washout periods may be difficult to interpret. The risk of attrition also may increase because of prolonged study duration. CONCLUSION By facilitating intraindividual comparisons and eliciting patient preferences, crossover studies can provide unique information on the superior intervention. Crossover designs should be considered for selected palliative care studies.

Which Treatment Is Better? Ascertaining Patient Preferences With Crossover Randomized Controlled Trials

INTRODUCTION In the United States, opioid regulations have become increasingly stringent in recent years. Increased regulatory scrutiny, in part, is related to heightened awareness through literature and a recent media blitz on the opioid prescription epidemic. These regulations have the potential to impact prescription trends by health care providers. Our objective was to evaluate changes in the type and dose of opioid prescriptions among patients who are referred by oncologists to an outpatient palliative care clinic. MATERIALS AND METHODS We reviewed the electronic health records of 750 patients who were seen as new consultations at MD Anderson Cancer Centers outpatient palliative care clinic between January 1 and April 30 each year from 2010 through 2015. Data collected included demographics, cancer type and stage, symptom assessment, performance status, opioid type, and opioid dose defined as the morphine equivalent daily dose (MEDD). RESULTS Median age was 59 years (interquartile range [IQR], 51 to 67), 383 (51%) were female, 529 (70%) were white, and 654 (87%)of patients had advanced cancer. In 2010, median MEDD before referral was 78 mg/d (IQR, 30 to 150); however, by 2015, the MEDD had progressively decreased to 40 mg/d (IQR, 19 to 80; P = .001). Hydrocodone was the most common opioid prescribed between 2010 and 2015; however, after its reclassification as a schedule II opioid in October 2014, the use of tramadol, a schedule IV opioid, increased ( P < .001). CONCLUSION During the past several years, the MEDD prescribed by referring oncologists has decreased. After hydrocodone reclassification, the use of tramadol with less stringent prescription limits has increased.

Opioid Prescription Trends Among Patients With Cancer Referred to Outpatient Palliative Care Over a 6-Year Period

ABSTRACT.  Timely and important studies are reviewed and commentaries provided by leading palliative care clinicians. Symptoms, interventions, and treatment-related adverse events addressed in this issue are haloperidol for nausea and vomiting; transdermal fentanyl and cachexia; drugs impact on opioid efficacy; denosumab for bone metastases; and cognitive behavioral insomnia therapy.

HALOPERIDOL FOR NAUSEA AND VOMITING

PC-FACS(FastArticleCriticalSummaries for Clinicians inPalliativeCare) provides hospice and palliative care clinicians with concise summaries of the most important findings from more than 100 medical and scientific journals. If you have colleagues who would benefit from receiving PC-FACS, please encourage them to join the AAHPM at aahpm.org. Comments from readers are welcomed at pc-facs@aahpm.org.

PC-FACSPC-FACS

106 Background: Opioid prescriptions are regulated at both federal and state levels. Examples of such regulations include use of risk evaluation and mitigation strategies (REMS), mandatory sharing of prescription data with state prescription drug monitoring programs and the reclassification of hydrocodone as schedule II opioid in October 2014. One possible consequence of such changes would be earlier referral to palliative care (PC) for opioid management. Alternatively, primary oncologist may treat patients with weak opioids or use strong opioids with lower daily dose. We hypothesized that during the last six years, the number of referrals to outpatient PC has increased and the morphine equivalent daily dose (MEDD) has decreased. METHODS We reviewed 750 randomly selected patients who were seen as a new consultation from the year 2010 to 2015. Data was collected on demographics, cancer type and stage, referring specialty, symptom assessment, cancer pain classification, performance status, opioid type and MEDD. Data were also collected on first subsequent PC visit among eligible patients. MEDD over the 6 years was evaluated using general linear regression method, adjusted for covariates. RESULTS Hydrocodone was the most common opioid prescribed by the referring team throughout the six-year period. After reclassification, its use declined from 43% in 2014 to 33% in 2015. Tramadol use increased from 9% in 2014 to 19% in 2015 (p < 0.0001). Median MEDD upon referral was 78mg/day in 2010 and progressively decreased to 40mg/day in 2015 (p < 0.0001). Year to year referral increased 24% in the first quarter of 2015 (after hydrocodone rescheduling), compared to 17% in 2014 (p 0.0014). CONCLUSIONS Over the past 6 years, there has been an increase in number of referrals to PC and a decline in MEDD upon referral. Likewise, an increase in weak opioids like tramadol has also been observed. These findings suggest oncologists are sending early referrals before further opioid dose titration and rotations are considered. Further opioid regulations will likely impact the integration of PC services in comprehensive cancer care.

Changes in opioid type and dose among cancer patients referred to outpatient palliative care.

Objectives Discuss PC-FACS processes and “vital statistics.” Discuss implications of cutting-edge research of clinical value to AAHPM members. PC-FACS (Fast Article Critical Summaries for Clinicians in Palliative Care), one of the highest-rated member benefits of AAHPM, offers busy clinicians an efficient way to stay on top of pertinent literature in a rapidly evolving field. In its 10th year, PC-FACS provides electronic summaries of just-published research from more than 100 non–hospice and palliative care journals that might not otherwise be regularly reviewed by our readership. Editorial Board members, peer experts selected from the Academy membership, write succinct, thought-provoking commentaries that have practical implications for practice and for the field as a whole. Monthly issues offer commentaries on topics including basic science; bioethics, humanities, and spirituality; geriatrics and care transitions; hospice, hospice and palliative medicine interface, and regulatory issues; pediatrics; psychosocial issues; and symptom assessment and management. PC-FACS also offers special issues that provide more in-depth coverage of timely topics. In this session, Editor-in-Chief Donna Zhukovsky and Associate Editor-in-Chief Mellar Davis will provide an inside line to PC-FACS