Current cannabis use and pain management among US cancer patients.

BACKGROUND: National studies reporting the prevalence of cannabis use have focused on individuals with a history of cancer without distinction by their treatment status, which can impact symptom burden. While pain is a primary motivation to use cannabis in cancer, the magnitude of its association with cannabis use remains understudied. METHODS: We examined cannabis use and pain management among 5523 respondents of the Behavioral Risk Factor Surveillance System with a cancer history. Survey-weighted prevalence proportions of respondents' cannabis use are reported, stratified on cancer treatment status. Regression models estimated odds ratios (ORs) and 95% confidence intervals (CIs) of cancer-related pain and cannabis use. RESULTS: Cannabis use was slightly more prevalent in those undergoing active treatment relative to those who were not undergoing active treatment (9.3% vs. 6.2%; P=0.05). Those under active treatment were more likely to use cannabis medicinally (71.6% vs. 50.0%; P=0.03). Relative to those without cancer-related pain, persons with pain under medical control (OR 2.1, 95% CI, 1.4-3.2) or uncontrolled pain were twice as likely to use cannabis (OR 2.0, 95% CI, 1.1-3.5). CONCLUSIONS: Use of cannabis among cancer patients may be related to their treatment and is positively associated with cancer-related pain. Future research should investigate the associations of cannabis use, symptom burden, and treatment regimens across the treatment spectrum to facilitate interventions.

Use of patient-reported outcome measures for oncology drugs receiving accelerated approval.

Patient-reported outcomes (PROs) represent an important evaluation of health-related quality of life that has become more commonly incorporated into oncology drug clinical trials. The frequency of PRO inclusion as an endpoint in oncology drug clinical trials leading to the initial accelerated approval of a new therapy is not yet known. We conducted a cross-sectional study evaluating all new drug applications submitted to the FDA over the past 10 years (2013-2022) that led to the initial approval of an oncology drug through the accelerated approval process. The objective was to assess whether the trials leading to such an approval included PROs. Between 2013 and 2022, the FDA approved 59 unique drugs for an oncology indication via the accelerated approval pathway, and 35 (59%) included a PRO assessment in the clinical trial. A median of 1 PRO measurement was used in each trial, with 23 different types of PRO assessment tools were used across the 59 new drug applications. In summary, we found that PRO measurements are inconsistently utilized in trials leading to initial accelerated approval of oncology drugs, and there seems to be a lack of harmonization of different PRO measurement tools used across trials.

Transfer Status and 90-Day Mortality in Intensive Care Unit Patients With Sepsis: A Propensity Matched Analysis.

BACKGROUND: Timely identification and management of sepsis in surgical patients is crucial, and transfer status may delay optimal treatment of these patients. The objective of this study was to compare in-house and 90-day mortality between patients primarily admitted or transferred into the surgical ICU (SICU) at a tertiary referral center. MATERIAL AND METHODS: All patients admitted to the SICU with a diagnosis of sepsis (Sepsis III) were reviewed at a single institution between 2014 to 2019 (n = 1489). Demographics, comorbidities, and sepsis presentation were compared between transferred (n = 696) and primary patients (n = 793). Primary outcomes evaluated were in-house and 90 day mortality in an unmatched and propensity score matched cohorts. A P value < 0.05 was considered statistically significant. RESULTS: Transfer patients were more likely to have obesity (60% versus 49%, P < 0.005), a higher median SOFA (6 (4-8) versus 5 (3-8), P = 0.007), and require vasopressors on admission (42% versus 35%, P = 0.004). Compared to primary patients, transfer patients exhibited higher rates of respiratory failure (76% versus 69%, P = 0.003), in-house (30% versus 17%, P < 0.005), and 90 day mortality (36% versus 24%, P < 0.005). After matching, transferred patients were associated with 75% and 83% increased odds of in-house and 90 day mortality after controlling for age, sex, race, comorbidities, BMI, and sepsis severity. CONCLUSIONS: Transfer status is associated with an over 80% increase in the odds of 90 day mortality for patients admitted to the SICU with sepsis. Aggressive patient identification and earlier transfer of those at higher risk of death may reduce this effect.

The Need for Accurate Risk Assessment in a High-Risk Patient Population: A NSQIP Study Evaluating Outcomes of Cholecystectomy in the Patient With Cancer.

BACKGROUND: Cholecystectomy is considered a low-risk procedure with proven safety in many high-risk patient populations. However, the risk of cholecystectomy in patients with active cancer has not been established. METHODS: The American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) database was queried to identify all patients with disseminated cancer who underwent cholecystectomy from 2005 to 2016. Postcholecystectomy outcomes were defined for patients with cancer and those without by comparing several outcomes measures. A multivariate model was used to estimate the odds of 30-d mortality. RESULTS: We compared outcomes in 3097 patients with disseminated cancer to a matched cohort of patients without cancer. Patients with cancer had more comorbidities at baseline: dyspnea (10.5% versus 7.0%, P < 0.0001), steroid use (10.1% versus 3.0%, P < 0.0001), and loss of >10% body weight in 6-mo prior (9.3% versus 1.6%, P < 0.0001). Patients with cancer sustained higher rates of wound (2.3% versus 5.6%, P < 0.0001), respiratory (1.4% versus 3.9%, P < 0.0001), and cardiovascular (2.0% versus 6.8%, P < 0.0001) complications. In addition, patients with disseminated cancer experienced a longer length of stay and higher 30-d mortality. Multivariate modeling showed that the odds of 30-d mortality was 3.3 times greater in patients with cancer. CONCLUSIONS: Compared to patients without cancer, those with disseminated cancer are at higher risk of complication and mortality following cholecystectomy. Traditional treatment algorithms should be used with caution and care decisions individualized based on the patient's disease status and treatment goals.

Leaving Against Medical Advice After Emergency General Surgery: Avoiding a Two-Hit Effect.

BACKGROUND: Emergency general surgery has higher adverse outcomes than elective surgery. Patients leaving the hospital against medical advice (AMA) have a greater risk for readmission and complications. We sought to identify clinical and demographic characteristics along with hospital factors associated with leaving AMA after EGS operations. METHODS: A retrospective review of the Nationwide Inpatient Sample was performed. All patients who underwent an EGS procedure accounting for >80% of the burden of EGS-related inpatient resources were identified. 4:1 propensity score analysis was conducted. Regression analyses determined predictive factors for leaving AMA. RESULTS: 546,856 patients were identified. 1085 (0.2%) patients who underwent EGS left AMA. They were more likely to be men (59% versus 42%), younger (median age 51 y, IQR [37.61] versus 54, IQR [38.69]), qualify for Medicaid (26% versus 13%) or be self-pay (17% versus 9%), and be within the lowest quartile median household income (40% versus 28%) (all P < 0.05). After applying 4:1 propensity score matching, individuals who were self-pay (OR 3.15, 95% CI 2.44-4.06) or insured through Medicare (OR 2.75, 95% CI 2.11-3.57) and Medicaid (OR 3.58, 95% CI 2.83-4.52) had increased odds of leaving AMA compared with privately insured patients. In addition, history of alcohol (OR 2.21, 95% CI 1.65-2.98), drug abuse (OR 4.54, 95% CI 3.23-6.38), and psychosis (OR 2.31, 95% CI 1.65-3.23) were associated with higher likelihood for leaving AMA. CONCLUSIONS: Patients undergoing EGS have a high risk of complications, and leaving AMA further increases this risk. Interventions to encourage safe discharge encompassing surgical, psychiatric, and socioeconomic factors are warranted to prevent a two-hit effect and compound postoperative risk.

Analyzing Outcomes Among Older Adults With Necrotizing Soft-Tissue Infections in the United States.

BACKGROUND: Necrotizing soft-tissue infections (NSTIs) encompass a group of severe, life-threatening diseases with high morbidity and mortality. Evidence suggests advanced age is associated with worse outcomes. To date, no large data sets exist describing outcomes in older individuals, and risk factor identification is lacking. METHODS: Retrospective data were obtained from the 2015 Medicare 100% sample. Included in the analysis were those aged ≥65 y with a primary diagnosis of an NSTI (gas gangrene, necrotizing fasciitis, cutaneous gangrene, or Fournier's gangrene). Risk factors for in-hospital mortality and discharge disposition were examined. Continuous variables were assessed using central tendency, t-tests, and Wilcoxon rank-sum tests. Categorical variables were assessed using the chi-squared and Fisher's exact tests. Statistical significance was defined as P < 0.05. RESULTS: 1427 patient records were reviewed. 59% of patients were male, and the overall mean age was 75.4±8.6 y. 1385 (97.0%) patients required emergency surgery for their NSTI diagnosis. The overall mortality was 5.3%. Several underlying comorbidities were associated with higher rates of mortality including cancer (OR: 3.50, P = 0.0009), liver disease (OR: 2.97, P = 0.03), and kidney disease (OR: 2.15, P = 0.01). While associated with high in-hospital mortality, these diagnoses were not associated with a difference in the rate of discharge to home compared with skilled nursing or rehab. Overall, patients discharged to skilled nursing facilities or rehab had higher rates of underlying comorbidities than patients who were discharged home (3 or more comorbid illness 84.3% versus 68.6%, P < 0.0001); however, no individual comorbid illness was associated with discharge location. CONCLUSIONS: In our Medicare data set, we identified several medical comorbidities that are associated with increased rates of in-hospital mortality. Patients with underlying cancers had the highest odds of increased mortality. The effect on outcomes of the potentially immunosuppressive cancer treatments in these patients is unknown. These data suggest that patients with underlying illnesses, especially cancer, kidney disease, or liver disease have higher mortalities and are more likely to be discharged to skilled nursing facilities or rehab. It is unclear why these illnesses were associated with these worse outcomes while others including diabetes and heart disease were not. These data suggest that these particular comorbid illnesses may have special prognostic implications, although further analysis is necessary to identify the causative factors.

Importance of Radiologists in Optimizing Outcomes for Older Americans with Acute Abdomen.

BACKGROUND: Patients presenting with acute abdominal pain often undergo a computed tomography (CT) scan as part of their diagnostic workup. We investigated the relationship between availability, timeliness, and interpretation of CT imaging and outcomes for life-threatening intra-abdominal diseases or "acute abdomen," in older Americans. METHODS: Data from a 2015 national survey of 2811 hospitals regarding emergency general surgery structures and processes (60.1% overall response, n = 1690) were linked to 2015 Medicare inpatient claims data. We identified beneficiaries aged ≥65 admitted emergently with a confirmatory acute abdomen diagnosis code and operative intervention on the same calendar date. Multivariable regression models adjusted for significant covariates determined odds of complications and mortality based on CT resources. RESULTS: We identified 9125 patients with acute abdomen treated at 1253 hospitals, of which 78% had ≥64-slice CT scanners and 85% had 24/7 CT technicians. Overnight CT reads were provided by in-house radiologists at 14% of hospitals and by teleradiologists at 66%. Patients were predominantly 65-74 y old (43%), white (88%), females (60%), and with ≥3 comorbidities (67%) and 8.6% died. STAT radiology reads by a board-certified radiologist rarely/never available in 2 h was associated with increased odds of systemic complication and mortality (adjusted odds ratio 2.6 [1.3-5.4] and 2.3 [1.1-4.8], respectively). CONCLUSIONS: Delays obtaining results are associated with adverse outcomes in older patients with acute abdomen. This may be due to delays in surgical consultation and time to source control while waiting for imaging results. Processes to ensure timely interpretation of CT scans in patients with abdominal pain may improve outcomes in high-risk patients.

Opioid and Other Medication Use and General Health Status in a Cohort of Older Adults.

OBJECTIVE: The aim of this study was to determine whether the use of opioids and other medications in a cohort of older adults was associated with self-reported health status. METHODS: Among participants in the Prostate, Lung, Colorectal, and Ovarian (PLCO) Screening Trial linked to Medicare Part D claims data and answering a quality-of-life questionnaire, we examined the relationship between medication use over a 5-year period and various self-reported health status variables assessed several years later, including overall health status (STATUS) and trouble with activities of daily living (TADL). Multivariable logistic regression was used to estimate odds ratios (ORs) for the health status variables and metrics of medication use, including >60-day use, and for opiates, chronic use, with models controlling for demographics (model I), additionally for chronic conditions (model II), and additionally for other medication use (model III). RESULTS: The study cohort included 22,844 PLCO participants (56% women, 90% non-Hispanic whites); 4.2% had chronic opioid use and 12.5% used for >60 days. Fair-poor STATUS was reported in 37.9% of participants with chronic opioid use versus 15.0% of participants without (p < 0.001). ORs for chronic opioid use for fair-poor STATUS (compared to good-excellent) were significantly elevated in all models but decreased from model I (OR = 3.6; 95% CI :3.1-4.1) to model II (OR = 2.7; 95% CI :2.3-3.1) to model III (OR = 2.1; 95% CI :1.8-2.5). ORs for TADL were generally similar to those for STATUS. Other drug classes also had significantly elevated model III ORs for fair-poor versus good-excellent STATUS (range 1.1-1.6). CONCLUSION: Frequent use of various medication classes correlated with measures of future health status in an elderly population, with opioids having the strongest association. The magnitude of the association decreased after controlling for concurrent chronic conditions but remained elevated. Future research should consider how the use of opioids and other medications impact measures of health-related quality of life.

Hospital Admissions Associated With Cancer Pain in Older Adults With and Without Dementia.

BACKGROUND: Neoplasm-related pain is often suboptimally treated, contributing to avoidable suffering and increased medical resource use and costs. We hypothesized that dementia may contribute to increased resource use and costs in patients hospitalized for neoplasm-related pain in the United States. AIMS: To examine how persons with cancer and dementia use medical resources and expenditures in US hospitals compared to ondividuals without dementia. DESIGN: This study examined a retrospective cohort. SETTING: Admissions to US hospitals for neoplasm-related pain from 2012-2016 PARTICIPANTS/SUBJECTS: METHODS: Data were obtained from the 2012-2016 National Inpatient Sample (NIS). The sample included hospital admissions of individuals aged 60 or older with a primary diagnosis of neoplasm-related pain. Dementia was defined using the International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM), and ICD-10-CM diagnosis codes. Primary outcomes were number of admissions, costs, and length of stay (LOS). Descriptive statistics and multivariable regression models were used to examine the relationships among dementia, costs, and LOS. RESULTS: Of 12,034 admissions for neoplasm-related pain, 136 (1.1%) included a diagnosis of dementia and 11,898 (98.9%) did not. Constipation was present in 13.2% and 24.5% of dementia and nondementia admissions, respectively. The median LOS was 4 days in persons with dementia and three in those without. Mean costs per admission were higher in persons without dementia ($10,736 vs. $9,022, p = .0304). In adjusted regression results, increased costs were associated with nonelective admissions and longer LOS, and decreased costs with age above the mean. In contrast, decreased LOS was associated with age above the mean and nonelective admissions. Dementia was associated with neither endpoint. CONCLUSION: This study provides nurses and other health care professionals with data to further explore opportunities for improvement in cancer pain management in patients with and without dementia that may optimize use of medical resources.

Identifying the fundamental structures and processes of care contributing to emergency general surgery quality using a mixed-methods Donabedian approach.

BACKGROUND: Acute Care Surgery (ACS) was developed as a structured, team-based approach to providing round-the-clock emergency general surgery (EGS) care for adult patients needing treatment for diseases such as cholecystitis, gastrointestinal perforation, and necrotizing fasciitis. Lacking any prior evidence on optimizing outcomes for EGS patients, current implementation of ACS models has been idiosyncratic. We sought to use a Donabedian approach to elucidate potential EGS structures and processes that might be associated with improved outcomes as an initial step in designing the optimal model of ACS care for EGS patients. METHODS: We developed and implemented a national survey of hospital-level EGS structures and processes by surveying surgeons or chief medical officers regarding hospital-level structures and processes that directly or indirectly impacted EGS care delivery in 2015. These responses were then anonymously linked to 2015 data from the American Hospital Association (AHA) annual survey, Medicare Provider Analysis and Review claims (MedPAR), 17 State Inpatient Databases (SIDs) using AHA unique identifiers (AHAID). This allowed us to combine hospital-level data, as reported in our survey or to the AHA, to patient-level data in an effort to further examine the role of EGS structures and processes on EGS outcomes. We describe the multi-step, iterative process utilizing the Donabedian framework for quality measurement that serves as a foundation for later work in this project. RESULTS: Hospitals that responded to the survey were primarily non-governmental and located in urban settings. A plurality of respondent hospitals had fewer than 100 inpatient beds. A minority of the hospitals had medical school affiliations. DISCUSSION: Our results will enable us to develop a measure of preparedness for delivering EGS care in the US, provide guidance for regionalized care models for EGS care, tiering of ACS programs based on the robustness of their EGS structures and processes and the quality of their outcomes, and formulate triage guidelines based on patient risk factors and severity of EGS disease. CONCLUSIONS: Our work provides a template for team science applicable to research efforts combining primary data collection (i.e., that derived from our survey) with existing national data sources (i.e., SIDs and MedPAR).

Variability in Opioid Equivalence Calculations.

OBJECTIVE: Equianalgesic conversion methods are commonly used to switch patients from one opioid to another due to suboptimal pain relief or adverse events. There is no universally accepted opioid conversion method, however, and there is often significant variability between conversion resources. As a result, patients are at risk for undertreated pain and serious adverse events. The purpose of this survey was to compare the equianalgesic conversion estimates between nurse practitioners, pharmacists, and physicians for commonly prescribed opioids. METHODS: A survey form was developed using Survey Monkey. Participation was solicited by providing a link to the survey via social media (e.g., Facebook, Twitter, LinkedIn, etc.) and emailing professional organizations for sharing with their members and followers. Data collected included demographics and estimated morphine equivalents (MEQs) of hydrocodone 80 mg, fentanyl transdermal patches 1,800 mcg (as 75 mcg/hour), methadone 40 mg, oxycodone 120 mg, and hydromorphone 48 mg. Participants were also asked to provide their choice of reference utilized to complete the conversions, including personal knowledge. Descriptive analyses were performed using measures of central tendency. Hypothesis testing was performed using Pearson's chi-squared and Fisher's Exact Test for categorical data and the Kruskal-Wallis equality of populations rank test for continuous data to assess differences between median opioid doses by professional groups. RESULTS: The total number of respondents included in the analysis was 319. Physicians, pharmacists, and nurse practitioners/physician assistants comprised 25.4%, 56.7%, and 16.3%, respectively, of respondents. The overall mean (± standard deviation) MEQ doses for fentanyl, hydrocodone, hydromorphone, methadone, and oxycodone were: 176 (±117) mg, 88 (±42) mg, 192 (±55) mg, 193 (±201) mg, and 173 (±39) mg, respectively. For fentanyl, the mean (±standard deviation) MEQ doses were 180 (±122) mg, 178 (±128) mg, and 157 (±68) mg, for physicians, pharmacists, and nurse practitioners/physician assistants, respectively. For all three groups of clinicians, the median MEQ dose for fentanyl was 150 mg. The mean (±standard deviation) MEQ doses of methadone for physicians, pharmacists, and nurse practitioners/physician assistants were: 214 (±142) mg, 171 (±107) mg, and 185 (±129) mg, respectively. The median MEQ dose for methadone was 160 mg for each of the clinician groups. CONCLUSIONS: As evidenced by large standard deviations, there was significant variation in mean opioid conversions to MEQ doses within each profession type, particularly for fentanyl and methadone. The median MEQ doses provided for opioid conversions were the same among each profession. No universal method exists that allows each of the five studied opioids to be accurately and consistently converted to another opioid (i.e., morphine).

Codeine, alone and with paracetamol (acetaminophen), for cancer pain.

BACKGROUND: Pain is very common in patients with cancer. Opioid analgesics, including codeine, play a significant role in major guidelines on the management of cancer pain, particularly for mild to moderate pain. Codeine is widely available and inexpensive, which may make it a good choice, especially in low-resource settings. Its use is controversial, in part because codeine is not effective in a minority of patients who cannot convert it to its active metabolite (morphine), and also because of concerns about potential abuse, and safety in children. OBJECTIVES: To determine the efficacy and safety of codeine used alone or in combination with paracetamol for relieving cancer pain. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL; The Cochrane Library 2014, Issue 2), MEDLINE and EMBASE from inception to 5 March 2014, supplemented by searches of clinical trial registries and screening of the reference lists of the identified studies and reviews in the field. SELECTION CRITERIA: We sought randomised, double-blind, controlled trials using single or multiple doses of codeine, with or without paracetamol, for the treatment of cancer pain. Trials could have either parallel or cross-over design, with at least 10 participants per treatment group. Studies in children or adults reporting on any type, grade, and stage of cancer were eligible. We accepted any formulation, dosage regimen, and route of administration of codeine, and both placebo and active controls. DATA COLLECTION AND ANALYSIS: Two review authors independently read the titles and abstracts of all studies identified by the searches and excluded those that clearly did not meet the inclusion criteria. For the remaining studies, two authors read the full manuscripts and assessed them for inclusion. We resolved discrepancies between review authors by discussion. Included studies were described qualitatively, since no meta-analysis was possible because of the small amount of data identified, and clinical and methodological between-study heterogeneity. MAIN RESULTS: We included 15 studies including 721 participants with cancer pain due to diverse types of malignancy. All studies were performed on adults; there were no studies on children. The included studies were of adequate methodological quality, but all except for one were judged to be at a high risk of bias because of small study size, and six because of methods used to deal with missing data or high withdrawal rates. Three studies used a parallel group design; the remainder were cross-over trials in which there was an adequate washout period, but only one reported results for treatment periods separately.Twelve studies used codeine as a single agent and three combined it with paracetamol. Ten studies included a placebo arm, and 14 included one or more of 16 different active drug comparators or compared different routes of administration. Most studies investigated the effect of a single dose of medication, while five used treatment periods of one, seven or 21 days. Most studies used codeine at doses of 30 mg to 120 mg.There were insufficient data for any pooled analysis. Only two studies reported our preferred responder outcome of 'participants with at least 50% reduction in pain' and two reported 'participants with no worse than mild pain'. Eleven studies reported treatment group mean measures of pain intensity or pain relief; overall for these outcome measures, codeine or codeine plus paracetamol was numerically superior to placebo and equivalent to the active comparators.Adverse event reporting was poor: only two studies reported the number of participants with any adverse event specified by treatment group and only one reported the number of participants with any serious adverse event. In multiple-dose studies nausea, vomiting and constipation were common, with somnolence and dizziness frequent in the 21-day study. Withdrawal from the studies, where reported, was less than 10% except in two studies. There were three deaths, in all cases due to the underlying cancer. AUTHORS' CONCLUSIONS: We identified only a small amount of data in studies that were both randomised and double-blind. Studies were small, of short duration, and most had significant shortcomings in reporting. The available evidence indicates that codeine is more effective against cancer pain than placebo, but with increased risk of nausea, vomiting, and constipation. Uncertainty remains as to the magnitude and time-course of the analgesic effect and the safety and tolerability in longer-term use. There were no data for children.

Pharmacists' training, perceived roles, and actions associated with dispensing controlled substance prescriptions.

OBJECTIVES: To examine situations that prompt pharmacists to access a prescription drug monitoring program (PDMP) database and management of opioid abuse/addiction; assess pharmacists' actions when abuse is suspected; describe pharmacists' tasks when dispensing controlled substance prescriptions (CSPs); and their continuing pharmacy education (CPE). DESIGN Cross-sectional mail survey of 1,000 randomly selected pharmacists. SETTING: Texas from February 2012 to April 2012. PARTICIPANTS: 1,000 Texas community pharmacists. INTERVENTION: Mail survey instrument. MAIN OUTCOME MEASURES: Prompts to use a PDMP and pharmacists' views actions, and related CPE programs. RESULTS The usable response rate was 26.2%. Pharmacists were more supportive of mandated PDMP use by physicians than by pharmacists (mean ± SD 4.1 ± 1.2 versus 3.2 ± 1.5; P <0.001), based on a 5-point Likert scale (1, strongly disagree, to 5, strongly agree). Most pharmacists would be prompted to use a PDMP if the prescription contains mistakes (68.1%) or the patient requests an early refill (66.3%). Bivariate statistics showed that men pharmacists, those with BSPharm degrees, and pharmacists ≥50 years of age reported a greater number of CPE hours related to prescription opioid abuse and pain management. An analysis of variance showed that pharmacy owners reported significantly more (P <0.05) CPE compared with manager and staff pharmacists. CONCLUSION: Older pharmacists with a BSPharm degree may be more willing to provide counseling to patients with opioid addiction based on their work experience and additional CPE related to controlled substances. As PDMP use becomes more prevalent, pharmacists should be prepared to interact and counsel patients identified with aberrant controlled prescription drug use and properly deliver pain management care. Additionally, schools of pharmacy curricula must prepare new pharmacists to prevent abuse and diversion, as well as intervene when aberrant use is identified.

Alpelisib-Induced Diabetic Ketoacidosis: A Pharmacovigilance Analysis of the FDA Adverse Event Reporting System and Review of the Literature.

BACKGROUND: Alpelisib is a PI3K inhibitor indicated with fulvestrant for treatment of advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated breast cancer. In the phase III SOLAR-1 trial, grade 3/4 hyperglycemic events were reported in 36.6% of patients receiving alpelisib-fulvestrant compared to 0.7% receiving placebo-fulvestrant. As case reports of diabetic ketoacidosis (DKA) have been associated with alpelisib use, the goal of this study was to characterize the FAERS reported cases of this severe adverse effect. METHODS: A retrospective disproportionality analysis was performed using the FAERS database by calculating the reporting odds ratio (ROR) of DKA events with alpelisib from 2019 to 2022. A PubMed literature review of case reports characterizing alpelisib-induced DKA was performed. RESULTS: Pharmacovigilance database analysis revealed significance in reporting among 87 DKA cases with alpelisib (ROR 9.84, 95% confidence interval 7.3-13.2), including hospitalization and death as reported outcomes. Review of 11 published case reports reveals median onset of DKA at 14 days with successful rechallenge possible. CONCLUSION: Significant association with reporting exists between DKA and alpelisib exposure. We observed similar median time to onset of hyperglycemia between our analysis compared to that reported in SOLAR-1. Considering early onset of this toxicity, it is imperative that patients be closely monitored when initiating alpelisib. Addition of a preemptive antihyperglycemic or escalation in those previously on antihyperglycemic medications is beneficial in decreasing the severity of hyperglycemia with alpelisib. Further study investigating risk factors is warranted to better elucidate which patients require preemptive therapy.

Associations of Cancer Patients' Demographic and Clinical Characteristics With Cannabis-Related Interest and Behaviors.

Background: Cannabis interest and use is increasing in the United States, yet research on its use among cancer patients is limited. Methods: Individuals with cancer completed an anonymous cross-sectional questionnaire. Multivariable logistic regressions estimated odds ratios (OR) between patients' demographic and clinical characteristics with cannabis-related interest, current use, and provider recommendation. Results: Participants (n = 943) were, on average, 61.7 years old. Older patients were less likely to use cannabis products (OR = 0.42, confidence interval [95% CI]: 0.26-0.69) and less likely to be interested in cannabis (OR = 0.60, 95% CI: 0.44-0.84) than younger patients. Those with higher education were less likely to be using cannabis (OR = 0.41, 95% CI: 0.25-0.67) and less likely to have received a provider recommendation of cannabis use than the least educated (OR = 0.38, 95% CI: 0.19-0.76). Cancer spread and type were significant correlates of provider recommendation of cannabis use. Conclusions: Additional research is warranted to better understand cancer patients' motivations for cannabis use and interest.

Testing the feasibility of mobile ecological momentary assessment for symptom burden and management among metastatic cancer patients.

Background: Individuals who have metastatic cancer experience substantial physical and psychological distress (e.g., pain, depression, anxiety) from their disease and its treatment compared to patients with less advanced disease. As the burden of symptoms varies over time, ecological momentary assessment (EMA) may be used to better understand patients' symptom trajectories, complimenting traditional longitudinal data collection methods. However, few have used EMA in patients with metastatic disease. The current study adds to the existing literature by exploring interrelated, common cancer-related symptoms of pain, anxiety, and depression and use of cannabis-based products, opioid medications, other (nonopioid) pain medications, and medications for anxiety or depression. Methods: An eight-day prospective observational feasibility study was conducted among 50 patients with metastatic cancer recruited from seven solid cancer clinics at The Ohio State University Comprehensive Cancer Center. Participants completed a week of interval-contingent mobile EMA, administered daily at 9 a.m., 3 p.m., and 8 p.m., and a comprehensive interviewer-administered questionnaire on Day 8. Participants were queried on their symptom burden and management strategies (i.e., use of medications and cannabis). We considered EMA to be feasible if a priori retention (80%) and adherence goals (75%) were met. Results: Seventy-nine percent of eligible patients contacted enrolled in the study (n = 50 of 63). Among those enrolled, 92% were retained through Day 8 and 80% completed >90% of EMAs, exceeding a priori objectives. Participants' average pain, anxiety, and depressive symptoms across the week of EMA ranged from 1.7 to 1.8 (1 to 5 scale). Symptoms varied little by day or time of administration. On Day 8, significant proportions of participants reported past-week use of medications and cannabis for symptom management. Conclusions: Participants exceeded a priori adherence and retention objectives, indicating that mobile EMA is feasible among metastatic cancer patients, addressing a gap in the existing literature and informing future research. Restricting eligibility to participants with a minimum cutoff of symptom burden may be warranted to increase observations of symptom variability and provide opportunities for future health interventions. Future research is needed to test the acceptability and quality of data over a longer study period in this patient population.

Does pain score in response to a standardized subcutaneous local anesthetic injection predict epidural steroid injection outcomes in patients with lumbosacral radiculopathy? A prospective correlational study.

OBJECTIVE: Epidural steroid injections (ESI) are the most commonly performed pain procedures. Despite numerous studies, controversy continues to surround their effectiveness. The purpose of this study is to determine whether a standard, clinical local anesthetic injection can predict outcomes for ESI. STUDY DESIGN: In this multicenter study, 103 patients received two ESI 2 weeks apart. Prior to their first injection, subjects rated the pain intensity of a standardized subcutaneous (SQ) injection of lidocaine prior to the full dose. Numerical rating scale pain scores were correlated with leg and back pain relief, and functional improvement, through 3-month follow-up. OUTCOME MEASURES: A composite successful outcome was predetermined to be a ≥2-point decrease in leg pain score, coupled with a positive global perceived effect. RESULTS: A small but significant relationship was found between SQ pain score and reduction in leg (r = -0.21, 95% CI -0.38 to -0.04; P = 0.03) and back pain (r = -0.22, 95% CI -0.36 to -0.07; P = 0.03). Subjects with a positive outcome at 1 month had a mean SQ pain score of 2.5 (SD 1.9) vs 4.1 (SD 2.7) in those with a negative outcome (P = 0.04). Subjects with SQ pain scores <4/10 had lower leg and back pain scores than those with pain scores ≥4 at 1-month (mean 3.2, SD 2.6 vs 5.1, SD 2.7 for leg, P < 0.01; mean 3.7, SD 2.6 vs 5.0, SD 3.0 for back, P = 0.02) and 3-month (mean 3.8, SD 2.7 vs 5.2, SD 3.1 for leg, P = 0.01; mean 4.0, SD 2.6 vs 4.9, SD 3.1 for back; P = 0.14) follow-up. CONCLUSIONS: The results of this study found a weak positive correlation between SQ pain scores and treatment results. Further research should consider whether pain perception in conjunction with other variables might prove to be a reliable predictor for ESI and other procedural outcomes.