Improving participant representation in the era of digital clinical studies.

Traditional clinical research relies on conventional strategies to invite and enroll research participants. However, these strategies often fail to reach potential participants from marginalized communities or that reflect the diversity of the nation, such as race, ethnicity, or geography. As we discuss here, the digital clinical study model sets the stage for improved and equitable participation in biomedical research.

Mobile Health-Collected Biophysical Markers in Children with Serious Illness-Related Pain.

Context: There is an ongoing established need to develop engaging pain assessment strategies to provide more effective individualized care to pediatric patients with serious illnesses. This study explores the acceptability of wireless devices as one option. Objective: To evaluate the ability of wrist-wearable technology to collect physiological data from children with serious illnesses. Methods: Single-site prospective observational study conducted between September 2017 and September 2018 at Rady Children's Hospital, San Diego, California, inpatient wards. Pediatric patients with diagnoses of cancer and sickle cell disease admitted to the hospital for acute-on-chronic pain and taking opioid pain medications were asked to complete two 24-hour continuous monitoring periods with the Empatica E4 wristband. Results: Data collected from the device correlated with manually obtained vital signs. Children responded favorably to wearing the device. Participants with reported subjective pain versus no pain had average heart rate increased by 16.4 bpm, skin temperature decreased by 3.5°C, and electrodermal activity decreased by 0.27. Conclusions: This study shows the possibility of collecting continuous biophysical data in a nonobtrusive manner in seriously ill children experiencing acute-on-chronic pain using wearable devices. It provides the framework for larger studies to explore the utility of such data in relation to metrics of pain and suffering in this patient population.

Clinical Tolerability and Safety of Tramadol in Hospitalized Patients.

Tramadol is a schedule IV, monoaminergic and µ-opioid-receptor analgesic with unique pharmacology properties. Though it is well established and widely utilized, there is little guidance on tramadol's place in therapy, including tolerability, safety and monitoring guidelines. Retrospective chart review of 250 patients who received oral tramadol during their hospitalization from January 1, 2018 to December 31, 2018. Of the 250 patients, 10.8% had cancer as their primary diagnosis while 8.8% were admitted for hematologic reasons. 79.1% of patients had acute pain. Palliative care consult or ICU admission resulted in significant discontinuation of tramadol (p < 0.05 odds ratio 6.88, 2.39). There was no significant relationship of hypoglycemia when evaluating days on tramadol, total number of doses on tramadol, and MEDD start and end (p = 0.36, 0.88, 0.15, 0.23 consecutively). The longer that patients were on tramadol and the more doses they received during their inpatient stay, the greater risk of a severe drug-drug interaction (p < 0.05; R 0.29). In hospitalized patients, the risk of major and severe drug-drug interactions with tramadol increased with dose and duration. Hospital medicine, bone marrow transplant, and emergency medicine teams predominantly used tramadol.

Emerging Challenges to the Safe and Effective Use of Methadone for Cancer-Related Pain in Paediatric and Adult Patient Populations.

Methadone continues to be an important medication for the treatment of paediatric and adult cancer-related pain. Appropriate patient selection to ensure safe and effective treatment by a team of clinicians who appreciate and are familiar with methadone and its unique pharmacology is crucial. Unlike morphine and other more common opioids, methadone is purported to have involvement with delta-opioid receptor and higher affinity as an N-methyl-D-aspartate-receptor antagonist. Clinically this gives it the advantage of being effective for both nociceptive and neuropathic pain, but also may be useful in the setting of tolerance to other opioids. Methadone also comes in multiple available formulations that can be administrated through a variety of routes beyond the oral route. Challenges with methadone in treating cancer-related pain include drug interactions specifically as it relates to new targeted cancer therapies. Recent guidelines recommend electrocardiogram monitoring with methadone and there is potential for additive cardiac toxicity in the oncology setting. Appropriate dosing of methadone for pain management given age, organ dysfunction, and patients who are on methadone maintenance therapy are also key factors. This article aims to provide clinicians with evidence and clinical practice guidelines for safe and appropriate use of methadone including indication, initiation, and monitoring given its complexity for management of pain in the dynamic oncology setting.

Do We Know What We Mean? An Examination of the Use of the Phrase "Goals of Care" in the Literature.

Background: There is no consensus approach to describe the process or components of goals of care (GOC) conversations. Objective: The objective was to review the utilization of the phrase "GOC" in PubMed-indexed literature to contextualize the use of the phrase. Secondary aim was to describe the use of this phrase within journals focused on palliative care. Methods: A review of articles in the PubMed-indexed literature published during a single year utilizing the phrase "goals of care." Results: A total of 191 articles were reviewed after exclusions. Few articles included an operant definition for GOC (n = 27, 14%). It was often used to describe conversations focused on determining intent for treatment (n = 57, 30%), talks about death or dying (n = 52, 27%), or simply vague discussions (n = 39, 20%). The agenda was focused on the outcomes of the conversation (n = 169, 88%) compared with factors such as hopes, worries, values, and personhood (n = 22, 12%). The majority did not utilize the phrase "palliative care" (n = 77, 40%); those who did frequently used "palliative care" incorrectly (n = 72, 38%). Conclusions: The definition of the phrase GOC is most often assumed with its context centered on the needs of the health care system and linked to a specific medical topic. It is most commonly used to describe determinations of the patient's therapy intent, second most commonly to describe end-of-life conversations. The use of the phrase GOC within the palliative literature does not differ notably from its use in the broader literature.

Results of a Naloxone Screening Quality-Improvement Project in an Academic Emergency Department.

BACKGROUND: The Emergency Department (ED) is a medical setting increasingly utilized by opioid users. In January 2016, our health system initiated a take-home naloxone education and distribution program. From July to August 2016, screening was performed in the ED to identify patients for take-home naloxone. OBJECTIVE: To evaluate the outcomes of routine screening for take-home naloxone in the ED setting and to determine key screening questions. Secondary analysis of Electronic Health Records for discrete elements that could help identify individuals for naloxone. METHODS: This is a single-center, retrospective cohort study conducted at two EDs within an academic health system. A screening tool was verbally administered to a convenience sample of ED patients as part of a pilot project to identify patients for overdose education and naloxone. Patient charts were reviewed retrospectively for pre-determined historical elements, medications prescribed, and substance use history. Descriptive and comparative analysis using Fisher two-tailed tests were performed with regard to historical elements, naloxone recommendation and prescription. RESULTS: A total of 182 patients were included. Following screening, 58 (31.9%) were identified as candidates for take-home naloxone. Of those, 36 (62.1%) accepted naloxone recommendation and 19 (32.8%) were prescribed naloxone. Individuals not prescribed naloxone despite recommendation either declined naloxone 22 (37.9%) or were not prescribed naloxone 17 (29.3%). Subanalysis of questions with binary yes/no answers (N = 171) demonstrated significant prediction of both naloxone recommendation (ROC = 0.944) and prescription (ROC = 0.897). CONCLUSIONS: Routine screening for take-home naloxone can help identify patients at-risk for opioid overdose and increase naloxone access in the ED.

Feasibility and Effectiveness of a Mnemonic Approach to Teach Residents How to Assess Goals of Care.

Background: Shared decision making is a collaborative process that allows patients, or their surrogates, and clinicians to make health care decisions together. There is an imperative to teach young physicians early in their training the importance of engaging in a shared decision-making process to define overall goals of care (GOC). The PERSON mnemonic proposes a structured format that allows providers to evaluate GOC across the spectrum of serious illnesses, outside of breaking bad news or end-of-life planning. Objectives: This study evaluated the utility of the PERSON mnemonic in training residents to have GOC with their patients, and investigated if these skills translated to the bedside with real patient encounters. Methods: First-year residents were divided into groups to participate in an in-depth education session. A pre-/postbaseline survey was administered immediately after the education intervention and approximately seven months later to assess retention and utility. Results: Thirty first-year residents were eligible for this study; 30 attended the educational sessions and completed the immediate baseline pre-/postsurvey and the seven-month follow-up survey, resulting in 100% retention rate throughout study. Residents found sustained utility in the mnemonic. It was significantly successful in increasing the knowledge and confidence level in exploring GOC. Patient-centered outcomes could not be analyzed due to low response rates and limited granularity of hospital-level data. Conclusion: The PERSON mnemonic is a feasible and useful format for teaching residents how to have a GOC discussion.

Prescribing Trends of Palliative Care Team's Use of Dexamethasone for Cancer-Related Pain.

Opioids are first-line therapy for cancer-related pain. In addition, corticosteroids are commonly utilized as adjuvant analgesics for pain and other symptoms in the oncology setting with limited supporting data. A retrospective analysis was conducted evaluating adult hospitalized patients receiving opioids who received once-daily dexamethasone on the recommendation of a specialty palliative care team during their hospitalization from January 1, 2015, to January 1, 2016. Primary end point was to describe prescribing patterns of dexamethasone in this patient population and secondarily examining any effect on oral morphine equivalent daily dose (MEDD), numeric pain score (NPS), and unwanted effects at 24 and 48 hours after the first dose of dexamethasone. Fifty-nine patients received an average dose of 13 mg (SD = 10) of dexamethasone for cancer-related pain, primarily acute pain (n = 36, 61%). Many died before hospital discharge or soon thereafter (n = 28, 47.5%). Although not statistically significant, our study shows a decrease of 23% and 19% in MEDD and NPS, respectively, without change in WBC after dexamethasone. A specialty palliative care team most often used once-daily dexamethasone for cancer-related pain in patients near the end of life. There were trends toward lower MEDD and NPS, but more robust studies are needed for validation.

Methadone Dose Selection for Treatment of Pain Compared with Consensus Recommendations.

BACKGROUND: Many factors make methadone an appealing option for treatment of pain in patients seen by palliative care; however, complex drug-related properties and variable patient response complicate appropriate conversion ratios from other opioids to methadone. Currently, there is no consensus regarding one accepted conversion method. OBJECTIVE: Current patterns of prescribing for clinicians at a three-hospital academic health system on initial rotation to methadone for the management of pain were compared with a series of consensus recommendations for methadone dose calculation. DESIGN: Retrospective chart review of 98 hospital patients. Settings/Participants: Adult subjects hospitalized in an academic medical center between January 1, 2013, and January 1, 2015, who were initiated on oral methadone for pain during the same admission. MEASUREMENTS: Final target daily dose of methadone was calculated using End of Life/Palliative Education Resource Center (EPERC) and Friedman conversion methods based on opioids provided in the prior 24 hours. This was then compared with actual dosing as ordered by clinicians and received by the patient. RESULTS: Average range of final daily methadone dose for new starts was 18.1 ± 16.7 mg. Final methadone dose as received by two-thirds of patients was below the dosing target calculated by EPERC and Friedman guidelines by an average of 35 mg. In addition, more than 80% of patients' final methadone doses fell below the range recommended by these two methods. No patients received opioid reversal agents during their index hospitalization. CONCLUSIONS: These findings may question the best approach to clinical application of EPERC and Friedman methods and call for more research to determine the safest, lowest, and most effective methadone target dosing selection. Final methadone dosing as received by patients compared favorably with a conservative methadone dosing method that recommends starting doses no higher than 30-40 mg per day.

Palliative Care Teams as Advocates for Adults with Sickle Cell Disease.

Medical advances have improved the overall life expectancy of patients with sickle cell disease (SCD). Unfortunately, the quality of life for patients with SCD remains a struggle. As the goal of palliative care (PC) is to improve quality of life for patients with serious illnesses, many PC teams are now asked to be involved in the care of these patients and may have variable levels of experience with SCD. Caring for patients with SCD is a complex and difficult task that often causes a reflexive "groan" from health care providers, which usually signifies a negative health care provider attitude stemmed from feeling uncomfortable in treating this complex patient population. It is important to be aware of these implicit biases and to overcome these feelings by becoming more familiar with the lives and experiences of those with SCD. This report provides an overview of SCD, context for the complexity of caring for this patient population, and areas for partnering in care.

Adolescents and young adults with life-threatening illness: special considerations, transitions in care, and the role of pediatric palliative care.

This article will cover the special considerations, challenges, and opportunities presented by caring for adolescents and young adults with life-threatening illnesses when the possibility of transition to an adult care setting arises.

Palliative care answers the challenges of transitioning serious illness of childhood to adult medicine.

Advances in the field of medicine have improved the overall life expectancy in children. Consequently, many children with previously lethal diseases now live into adulthood. There is an urgent need to develop approaches that assist with the transition of care from pediatrics to adult medicine. Palliative care, by virtue of its unique skills, is ideally positioned to play a part in this transition. This report will summarize the urgency for proper transition modalities and then introduce palliative care as a proposed solution for current challenges in transition. Along the way, it will touch on financial and workforce obstacles to this solution and will offer a potential funding option.