Surgical versus non-surgical management for patients with malignant bowel obstruction (S1316): a pragmatic comparative effectiveness trial.

BACKGROUND: Malignant small bowel obstruction has a poor prognosis and is associated with multiple related symptoms. The optimal treatment approach is often unclear. We aimed to compare surgical versus non-surgical management with the aim to determine the optimal approach for managing malignant bowel obstruction. METHODS: S1316 was a pragmatic comparative effectiveness trial done within the National Cancer Trials Network at 30 hospital and cancer research centres in the USA, Mexico, Peru, and Colombia. Participants had an intra-abdominal or retroperitoneal primary cancer confirmed via pathological report and malignant bowel disease; were aged 18 years or older with a Zubrod performance status 0-2 within 1 week before admission; had a surgical indication; and treatment equipoise. Participants were randomly assigned (1:1) to surgical or non-surgical treatment using a dynamic balancing algorithm, balancing on primary tumour type. Patients who declined consent for random assignment were offered a prospective observational patient choice pathway. The primary outcome was the number of days alive and out of the hospital (good days) at 91 days. Analyses were based on intention-to-treat linear, logistic, and Cox regression models combining data from both pathways and adjusting for potential confounders. Treatment complications were assessed in all analysed patients in the study. This completed study is registered with ClinicalTrials.gov, NCT02270450. FINDINGS: From May 11, 2015, to April 27, 2020, 221 patients were enrolled (143 [65%] were female and 78 [35%] were male). There were 199 evaluable participants: 49 in the randomised pathway (24 surgery and 25 non-surgery) and 150 in the patient choice pathway (58 surgery and 92 non-surgery). No difference was seen between surgery and non-surgery for the primary outcome of good days: mean 42·6 days (SD 32·2) in the randomised surgery group, 43·9 days (29·5) in the randomised non-surgery group, 54·8 days (27·0) in the patient choice surgery group, and 52·7 days (30·7) in the patient choice non-surgery group (adjusted mean difference 2·9 additional good days in surgical versus non-surgical treatment [95% CI -5·5 to 11·3]; p=0·50). During their initial hospital stay, six participants died, five due to cancer progression (four patients from the randomised pathway, two in each treatment group, and one from the patient choice pathway, in the surgery group) and one due to malignant bowel obstruction treatment complications (patient choice pathway, non-surgery). The most common grade 3-4 malignant bowel obstruction treatment complication was anaemia (three [6%] patients in the randomised pathway, all in the surgical group, and five [3%] patients in the patient choice pathway, four in the surgical group and one in the non-surgical group). INTERPRETATION: In our study, whether patients received a surgical or non-surgical treatment approach did not influence good days during the first 91 days after registration. These findings should inform treatment decisions for patients hospitalised with malignant bowel obstruction. FUNDING: Agency for Healthcare Research and Quality and the National Cancer Institute. TRANSLATION: For the Spanish translation of the abstract see Supplementary Materials section.

Is This ACP? A Focus Group Study of Patient Experiences of Advance Care Planning.

BACKGROUND: To date, most research on patients' experiences with advance care planning (ACP) focuses on motivations to engage in discussions and how patients prepare. Gaps remain in understanding how non-critically ill Medicare patients perceive ACP encounters, including how they characterize positive and negative experiences with ACP. OBJECTIVES: Understanding these patients' perceptions is imperative as Medicare has sought to incentivize provision of ACP services via two billing codes in 2016. DESIGN: Qualitative focus group study. Thematic analysis was performed to assess participants ACP experience. PARTICIPANTS: Medicare beneficiaries who had engaged in or were billed for ACP. KEY RESULTS: Seven focus groups were conducted with 34 Medicare beneficiaries who had engaged in ACP across 5 US health systems. Participants described a spectrum of perceptions regarding ACP, and a range of delivery approaches, including group ACP, discussions with specialists during serious illness, and ACP in primary care settings during wellness visits. Despite being billed for ACP or having ACP services noted in their medical record, many did not recognize that they had engaged in ACP, expressed lack of clarity over the term "ACP," and were unaware of the Medicare billing codes. Among participants who described quality patient-centered ACP experiences, three additional themes were identified: trusted and established patient/clinician relationships, transparent communication and documentation, and an understanding that ACP is revisable. Participants offered recommendations for clinicians and health systems to improve the patient ACP experience. CONCLUSIONS: Findings include actionable steps to promote patient-centered ACP experiences, including clinician training to support improved communication and facilitating shared decision-making, allocating sufficient clinical time for discussions, and ensuring that documentation of preferences is clear and accessible. Other approaches such as group ACP and ACP navigators may help to support patient interests within clinical constraints and need to be further explored.

Understanding The Use Of Medicare Procedure Codes For Advance Care Planning: A National Qualitative Study.

In 2016 Medicare introduced advance care planning Current Procedural Terminology (CPT) codes to reimburse clinicians for time spent providing the service. Despite recent increases, use of these codes remains low for reasons incompletely captured by quantitative research. To further identify barriers and facilitators to code use for Medicare fee-for-service enrollees, we conducted case studies at eleven health systems, including 272 interviews with clinicians, administrators, and key leadership. Five themes related to use of the new codes emerged: code-based constraints to billing, burdening patients with unexpected charges, ethical concerns with billing for discussion of advance care plans, incentives to signal the importance of their use in billing, and increasing both workflow burden and the need for institutional supports and training. Respondents also observed that use was facilitated by health systems' investment in clinician training and in processes to audit the codes' use. Our findings suggest that increased reimbursement, strong institutional commitment and support, and streamlined workflow could improve the use of the new CPT codes to document receipt of and ensure access to Medicare advance care planning.

Speaker Introductions at Grand Rounds: Differences in Formality of Address by Gender and Specialty.

Background: Despite increasing representation of women in medicine, gender bias remains pervasive. The authors sought to evaluate speaker introductions by gender in the grand rounds of multiple specialties at a large academic institution to understand the cultural context of this behavior and identify predictors of formality. Materials and Methods: The authors reviewed grand rounds recordings of speakers with doctorates presenting to the departments of family medicine, general surgery, internal medicine, obstetrics and gynecology, and pediatrics at one institution from 2014 to 2019. The primary outcome was whether a speaker's professional title was used as the first form of address. The authors assessed factors correlated with professional introduction using multivariable logistic regression. Results: Speakers were introduced professionally in 346/615 recordings (56.3%). Female introducers were more likely to introduce speakers professionally (odds ratio [OR]: 2.52). A significant interaction existed between speaker gender and home institution: female speakers visiting from an external institution were less likely than male external speakers to be introduced professionally (OR: 0.49), whereas female speakers internal to the institution were more likely to be introduced professionally than male internal speakers (OR: 1.75). Use of professional titles varied by specialty and was higher than average for family medicine (83.2%), surgery (75.8%), and pediatrics (64.0%) and lower for internal medicine (37.5%) and obstetrics and gynecology (50.7%). Conclusions: These findings suggest a complex relationship between gender and formality of introduction that merits further investigation. Understanding differences in culture across specialties is important to inform efforts to promote equity.

Specialty Palliative Care in COVID-19: Early Experiences from the Palliative Care Quality Collaborative.

Background: The COVID-19 pandemic has spurred unprecedented need for specialty palliative care. The Palliative Care Quality Collaborative (PCQC) provides unique infrastructure for rapid data collection and analysis. Objectives: To capture and describe real-time, real-world experiences of specialty palliative care professionals caring for patients with COVID-19 through a rapid reporting tool and registry. Setting: Palliative care clinicians consulted for patients either positive for COVID-19, under investigation for COVID-19, or recovered from COVID-19. Design: The PCQC created a 13-item COVID-19 case report form (CRF), modeled after the PCQC core dataset for specialty palliative care quality measurement. Twelve items offered discrete answer choices and one was open-ended. The CRF was publicized widely (e.g., social media, e-mail list serves) and completed through a link on the PCQC website. Results: Three hundred six reports (298 adult, 8 pediatric) were submitted between April 6, 2020 and October 7, 2020. The majority of patients (83%) were 50 years or older; 25% were 80 or older, and 78% were COVID-19 positive. Male gender identity was significantly more prevalent than female (58% vs. 40%, p < 0.002). The most common comorbidity was cardiovascular disease (23%). Of adult hospital-based patients, 69% were full code before palliative care consultation versus 28% after (p < 0.05). All pediatric patients were full code before and after palliative care consult. Qualitative themes were strained communication with patients, family visitation challenges, communication barriers between clinicians and families, rapid changes in palliative care medical management, community care options difficult to find, lack of testing in community-based settings, and guardianship and legal challenges. Conclusion: Preliminary data from the first 306 patients reported to the PCQC COVID-19 Registry describe palliative care use concentrated among older and higher risk patients and challenges to the provision of palliative care during this pandemic.

End-of-Life Care: Serious Illness Progression, Prognostication, and Advance Care Planning.

Because of their longstanding relationships with patients, family physicians often are in the best position to identify signs of serious illness progression, provide support and guidance to patients and caregivers, and tailor care plans to individual needs and preferences at the end of life. Significant signs of illness progression include worsening of one or more conditions, decline in function, and increase in the number of emergency department visits or hospitalizations. Prognostication refers to estimation of the remaining life expectancy. Several tools are available to inform such estimates. Prognostication should include discussion of the expected illness progression to help patients and family members prepare, plan, and cope. Advance care planning, ideally started before or early in the course of illness, should include identification of patient surrogate decision-makers as well as a discussion of patient values, priorities, and care preferences. Planning should continue and evolve to inform care plans that match patient and family member priorities at each stage of illness. Family physicians should be familiar with resources available in their communities to support care plans, including palliative care subspecialists, home- and facility-based palliative care teams, and hospice physicians.

Comparing Methadone Rotation to Consensus Opinion.

CONTEXT: Methadone is a complex but useful medication for pain management in palliative care. Recent expert opinions have been published on the safe and effective use of methadone. OBJECTIVES: To determine the success of methadone rotations and evaluate concordance with consensus recommendations by a palliative care consult service. METHODS: A retrospective study of methadone rotation practice by a palliative care consult service and outcomes for patients hospitalized between January 1, 2012 and December 31, 2018 at a single academic medical center. A successful rotation was defined as a 30% reduction in pain or as-needed medication use sustained for at least three consecutive days. Patient outcomes were compared with expert consensus recommendations. RESULTS: About 59 patients met the inclusion criteria. The study population was mostly Caucasian men and women of equal proportions who were started on methadone for inadequate pain control. Sixty-eight percent of patients were successfully rotated. Subjects who were rotated using a standardized protocol were six times more likely to have a successful rotation (odds ratio 6.28 [1.25-30.92]; P = 0.0238). CONCLUSION: The utilization of a standardized protocol was associated with better patient outcomes.

Intellectual Equipoise and Challenges: Accruing Patients With Advanced Cancer to a Trial Randomizing to Surgical or Nonsurgical Management (SWOG S1316).

BACKGROUND: Prospective, randomized trials are needed to determine optimal treatment approaches for palliative care problems such as malignant bowel obstruction (MBO). Randomization poses unique issues for such studies, especially with divergent treatment approaches and varying levels of equipoise. We report our experience accruing randomized patients to the Prospective Comparative Effectiveness Trial for Malignant Bowel Obstruction (SWOG S1316) study, comparing surgical and nonsurgical management of MBO. METHODS: Patients with MBO who were surgical candidates and had treatment equipoise were accrued and offered randomization to surgical or nonsurgical management. Patients choosing nonrandomization were offered prospective observation. Trial details are listed on www.clinicaltrials.gov (NCT #02270450). An accrual algorithm was developed to enhance enrollment. RESULTS: Accrual is ongoing with 176 patients enrolled. Most (89%) patients chose nonrandomization, opting for nonsurgical management. Of 25 sites that have accrued to this study, 6 enrolled patients on the randomization arm. Approximately 59% (20/34) of the randomization accrual goal has been achieved. Patient-related factors and clinician bias have been the most prevalent reasons for lack of randomization. An algorithm was developed from clinician experience to aid randomization. Using principles in this tool, repeated physician conversations discussing treatment options and goals of care, and a supportive team-approach has helped increase accrual. CONCLUSIONS: Experience gained from the S1316 study can aid future palliative care trials. Although difficult, it is possible to randomize patients to palliative studies by giving clinicians clear recommendations utilizing an algorithm of conversation, allotment of necessary time to discuss the trial, and encouragement to overcome internal bias.

Policy Changes Key To Promoting Sustainability And Growth Of The Specialty Palliative Care Workforce.

Specialized palliative care teams improve outcomes for the steadily growing population of people living with serious illness. However, few studies have examined whether the specialty palliative care workforce can meet the growing demand for its services. We used 2018 clinician survey data to model risk factors associated with palliative care clinicians leaving the field early, and we then projected physician numbers from 2019 to 2059 under four scenarios. Our modeling revealed an impending "workforce valley," with declining physician numbers that will not recover to the current level until 2045, absent policy change. However, sustained growth in the number of fellowship positions over ten years could reverse the worsening workforce shortage. There is an immediate need for policies that support high-value, team-based palliative care through expansion in all segments of the specialty palliative care workforce, combined with payment reform to encourage the deployment of sustainable teams.

Provider Perspectives on Topical Analgesics.

Topical analgesics are effective and alternative means to systemic therapy, often minimizing the adverse drug effects and complications of systemic analgesic use. Despite the number of available topical analgesics, there is little direction provided in practice guidelines on their appropriate use and little is known about patterns of their prescribing. To begin understanding these knowledge gaps, we sought provider perspectives on topical analgesic use at a large academic medical center. This electronic survey seeks to explore the perceptions and prescription patterns of topical analgesics among prescribers in a large academic medical center, where the availability of topical analgesics varies. Among topical analgesics, lidocaine (78%) is prescribed more frequently than nonsteroidal anti-inflammatory drugs (NSAIDs; 41%) or morphine (3%). Formulations and indications of use varied between faculty physicians and nonfaculty providers. Reasons for prescribing were largely based on anecdotal experience. Based on the survey results, it is clear that more topical agents are needed to manage pain; however, so too is guidance on appropriate prescribing.

Guidelines of care for the management of basal cell carcinoma.

Basal cell carcinoma (BCC) is the most common form of human cancer, with a continually increasing annual incidence in the United States. When diagnosed early, the majority of BCCs are readily treated with office-based therapy, which is highly curative. In these evidence-based guidelines of care, we provide recommendations for the management of patients with BCC, as well as an in-depth review of the best available literature in support of these recommendations. We discuss biopsy techniques for a clinically suspicious lesion and offer recommendations for the histopathologic interpretation of BCC. In the absence of a formal staging system, the best available stratification based on risk for recurrence is reviewed. With regard to treatment, we provide recommendations on treatment modalities along a broad therapeutic spectrum, ranging from topical agents and superficially destructive modalities to surgical techniques and systemic therapy. Finally, we review the available literature and provide recommendations on prevention and the most appropriate follow-up for patients in whom BCC has been diagnosed.

Guidelines of care for the management of cutaneous squamous cell carcinoma.

Cutaneous squamous cell carcinoma (cSCC) is the second most common form of human cancer and has an increasing annual incidence. Although most cSCC is cured with office-based therapy, advanced cSCC poses a significant risk for morbidity, impact on quality of life, and death. This document provides evidence-based recommendations for the management of patients with cSCC. Topics addressed include biopsy techniques and histopathologic assessment, tumor staging, surgical and nonsurgical management, follow-up and prevention of recurrence, and management of advanced disease. The primary focus of these recommendations is on evaluation and management of primary cSCC and localized disease, but where relevant, applicability to recurrent cSCC is noted, as is general information on the management of patients with metastatic disease.

Linking Quality and Spending to Measure Value for People with Serious Illness.

BACKGROUND: Healthcare payment is rapidly evolving to reward value by measuring and paying for quality and spending performance. Rewarding value for the care of seriously ill patients presents unique challenges. OBJECTIVE: To evaluate the state of current efforts to measure and reward value for the care of seriously ill patients. DESIGN: We performed a PubMed search of articles related to (1) measures of spending for people with serious illness and (2) linking spending and quality measures and rewarding performance for the care of people with serious illness. We limited our search to U.S.-based studies published in English between January 1, 1960, and March 31, 2017. We supplemented this search by identifying public programs and other known initiatives that linked quality and spending for the seriously ill and extracted key program elements. RESULTS: Our search related to linking spending and quality measures and rewarding performance for the care of people with serious illness yielded 277 articles. We identified three current public programs that currently link measures of quality and spending-or are likely to within the next few years-the Oncology Care Model; the Comprehensive End-Stage Renal Disease Model; and Home Health Value-Based Purchasing. Models that link quality and spending consist of four core components: (1) measuring quality, (2) measuring spending, (3) the payment adjustment model, and (4) the linking/incentive model. We found that current efforts to reward value for seriously ill patients are targeted for specific patient populations, do not broadly encourage the use of palliative care, and have not closely aligned quality and spending measures related to palliative care. CONCLUSIONS: We develop recommendations for policymakers and stakeholders about how measures of spending and quality can be balanced in value-based payment programs.

Dexmedetomidine as adjuvant therapy for acute postoperative neuropathic pain crisis.

BACKGROUND: Dexmedetomidine is a potent α2-adrenergic agonist U.S. Food and Drug Administration (FDA) approved for sedation. While its use as an analgesic has been described in the palliative medicine literature, its use for managing an acute neuropathic pain episode is less well known. METHODS: Here we describe the use of adjuvant dexmedetomidine in a patient with metastatic sarcoma suffering from an acute postoperative neuropathic pain crisis. CONCLUSION: Among patients with acute neuropathic pain for whom additional opioids raises respiratory-related concerns, the use of dexmedetomidine should be considered as a viable treatment alternative.

Rational use of opioids for management of chronic nonterminal pain.

Opioid prescribing for chronic nonterminal pain has increased in recent years, although evidence for its long-term effectiveness is weak and its potential for harm is significant. Nonmedical use of prescription opioids, diversion, and overdose deaths have also increased sharply, sparking concern about the safety of these medications. Physicians considering initiation or continuation of opioid therapy for a patient with chronic nonterminal pain should first use a structured approach that includes a biopsychosocial evaluation and a treatment plan that encourages patients to set and reach functional goals. There should be a comprehensive evaluation for the cause of pain, assessment for risk of opioid complications (including misuse and addiction), and a detailed treatment history, including a review of medical records and data from the state prescription monitoring program. Opioids should be prescribed on a trial basis, to be continued only if progress toward functional goals is demonstrated. Long-acting morphine is the preferred initial drug, although several alternatives are available. Ongoing monitoring for safety and effectiveness is essential, including regular review of functional progress or maintenance, urine drug testing, and surveillance of data from the state prescription monitoring program. Ineffective, unsafe, or diverted opioid therapy should be promptly tapered or stopped.

A call for guidance in the use of left ventricular assist devices in older adults.

Left ventricular assist devices (LVADs) are approved as "destination therapy" (permanent use without plans for transplantation) in individuals with advanced heart failure who are not candidates for a cardiac transplant; as such, these devices are increasingly being used in older adults. Although LVADs have been shown to increase quality of life and survival, the associated treatment burdens and complications deserve careful consideration. The current study illustrates myriad clinical challenges that can arise during long-term mechanical support using an older adult case history. Current data on LVAD use in older adults is reviewed, and a discussion of relevant points to consider before LVAD implantation in older adults, including advance care planning, assessment of gait and cognition, and the potential for substantial caregiver burden, is undertaken.

Antimicrobial use among patients receiving palliative care consultation.

BACKGROUND: We sought to characterize antimicrobial use among patients receiving palliative care consultation. METHODS: Retrospective review of patients seen by the Palliative Care Service at the University of Michigan Health System from January 2008 to May 2008. RESULTS: Of 131 patients seen in consultation, 70 received antimicrobials. We identified 92 infections among these 70 patients; therapy for 54 (58.7%) was empiric. Empiric therapy was most commonly prescribed for respiratory infection and urinary tract infection. Piperacillin/tazobactam (P/T) was the most frequently used agent, with 26 patients receiving P/T (37.1%); 22 of 26 received this agent empirically (84.6%, P = .005). Vancomycin was prescribed to 23 patients (32.9%). Sixteen patients (22.9%) died in hospital; another 31 were enrolled in hospice care. CONCLUSIONS: Our results suggest significant use of empiric, broad-spectrum antimicrobial therapy among hospitalized patients near the end of life. We advocate for careful assessment of potential benefits and treatment burdens of antimicrobial therapy, especially when palliation is the goal.