A Cross-Sectional Survey Study of Cannabis Use for Fibromyalgia Symptom Management.

OBJECTIVE: To assess the use of cannabis as a symptom management strategy for patients with fibromyalgia. PATIENTS AND METHODS: An electronic, cross-sectional survey was conducted among patients diagnosed with fibromyalgia and treated in Integrative Medicine & Health at Mayo Clinic, Rochester, Minnesota. The survey was constructed with the Symptom Management Theory tool and was sent anonymously via web-based software to patients with a diagnosis of fibromyalgia. RESULTS: Of 5234 patients with fibromyalgia sent the online survey, 1336 (25.5%) responded and met the inclusion criteria. Survey respondents had a median age of 48 (Q1-Q3: 37.5-58.0) years, and most identified as female. Nearly half of respondents (49.5%, n=661) reported cannabis use since their fibromyalgia diagnosis. The most common symptoms for which respondents reported using cannabis were pain (98.9%, n=654); fatigue (96.2%; n=636); stress, anxiety, or depression (93.9%; n=621); and insomnia (93.6%; n=619). Improvement in pain symptoms with cannabis use was reported by 82.0% (n=536). Most cannabis-using respondents reported that cannabis also improved symptoms of stress, anxiety, and depression and of insomnia. CONCLUSION: Considering that cannabis is a popular choice among patients for managing fibromyalgia symptoms, clinicians should have adequate knowledge of cannabis when discussing therapeutic options for fibromyalgia with their patients.

Effect of an Artificial Intelligence Decision Support Tool on Palliative Care Referral in Hospitalized Patients: A Randomized Clinical Trial.

CONTEXT: Palliative care services are commonly provided to hospitalized patients, but accurately predicting who needs them remains a challenge. OBJECTIVES: To assess the effectiveness on clinical outcomes of an artificial intelligence (AI)/machine learning (ML) decision support tool for predicting patient need for palliative care services in the hospital. METHODS: The study design was a pragmatic, cluster-randomized, stepped-wedge clinical trial in 12 nursing units at two hospitals over a 15-month period between August 19, 2019, and November 17, 2020. Eligible patients were randomly assigned to either a medical service consultation recommendation triggered by an AI/ML tool predicting the need for palliative care services or usual care. The primary outcome was palliative care consultation note. Secondary outcomes included: hospital readmissions, length of stay, transfer to intensive care and palliative care consultation note by unit. RESULTS: A total of 3183 patient hospitalizations were enrolled. Of eligible patients, A total of 2544 patients were randomized to the decision support tool (1212; 48%) and usual care (1332; 52%). Of these, 1717 patients (67%) were retained for analyses. Patients randomized to the intervention had a statistically significant higher incidence rate of palliative care consultation compared to the control group (IRR, 1.44 [95% CI, 1.11-1.92]). Exploratory evidence suggested that the decision support tool group reduced 60-day and 90-day hospital readmissions (OR, 0.75 [95% CI, 0.57, 0.97]) and (OR, 0.72 [95% CI, 0.55-0.93]) respectively. CONCLUSION: A decision support tool integrated into palliative care practice and leveraging AI/ML demonstrated an increased palliative care consultation rate among hospitalized patients and reductions in hospitalizations.

Comorbid extra-intestinal central sensitization conditions worsen irritable bowel syndrome in primary care patients.

BACKGROUND: Irritable bowel syndrome (IBS) is characterized as a central sensitization syndrome (CSS), a group of conditions including fibromyalgia, chronic fatigue, and restless leg syndrome (RLS) among others with frequent comorbidities of anxiety, depression, and chemical sensitivity. The prevalence of comorbid conditions and their impact on IBS symptom severity and quality of life in rural community populations has not been described. METHODS: We administered a cross-sectional survey to patients with a documented CSS diagnosis in rural primary care practices to evaluate the relationship between CSS diagnoses, quality of life, symptom severity, and interactions with healthcare providers utilizing validated questionnaires. Subgroup analysis was performed on the IBS cohort. Mayo Clinic IRB approved the study. KEY RESULTS: Seven hundred seventy-five individuals out of 5000 completed the survey (15.5% response rate) with 264 (34%) reporting IBS. Only 3% (n = 8) of IBS patients reported IBS alone without comorbid CSS condition. Most respondents reported overlapping migraine (196, 74%), depression (183, 69%), anxiety (171, 64%), and fibromyalgia (139, 52%). IBS patients with more than two comorbid CS condition showed significantly higher symptom severity with linear increase. Quality of life was lower in IBS with comorbid conditions, particularly in patients with IBS and RLS (mean EQ5-D 0.36 vs. 0.8 in IBS only, p < 0.01). Quality of life declined as number of comorbid conditions increased. CONCLUSIONS & INFERENCES: Patients with IBS often have multiple CS disorders which increases symptom severity and lowers quality of life. Understanding the impact of multiple CSS diagnoses and treating these as a global condition may improve patient experience.

Cannabis in Cancer Survivors Who Report High Impact Chronic Pain: Findings from a 1500+ Patient Survey.

BACKGROUND: Chronic pain in cancer survivors negatively impacts quality of life. This study sought to investigate the relationship between high-impact chronic pain (HICP) -- defined as chronic pain that limits life or work activities on most days or every day in the past 3 months -- and cannabis in cancer survivors. METHODS: An electronic survey was developed in conjunction with the National Cancer Institute Comprehensive Cancer Centers in the United States. This survey was distributed to cancer survivors within a multi-site, single institution setting. RESULTS: The survey response rate was 23.0% (2304/10,000); 72.7% of these patients (1676/2304) did in fact have a confirmed cancer diagnosis. Among these cancer survivors, 16.5% (unweighted 278/1676) had HICP, and 12.4% (208/1676) reported cannabis use since their cancer diagnosis. The prevalence of past 30-day cannabis use was 12.3% (206/1676). Compared to cancer survivors without pain, those with HICP were more likely to believe in the benefits of cannabis (unweighted 92.1% vs. 74.7%; age-adjusted odds ratio [OR] = 3.1; 95% CI: 1.9-5.1) and less likely to believe in its risks (unweighted 48.2% vs. 58.4%; age-adjusted OR = 0.6; 95% CI: 0.4-0.7). CONCLUSIONS: Cancer survivors with HICP have a higher prevalence of cannabis use compared to those patients without pain. More research is needed to advance pain and symptom management among cancer survivors and to identify clinical scenarios in which benefit is greater than potential harm.

Creation of a Multispecialty Clinic for Patients with Central Sensitization-Based Chronic Pain Conditions.

OBJECTIVE: To design and evaluate, through a human-centered design approach, a multispeciality clinic for patients with central sensitization syndromes that combined virtual previsit consultations, traditional face-to-face appointments, and technology-enabled educational programming. PATIENTS AND METHODS: Patients with suspected fibromyalgia and chronic abdominal pain were seen in a multispecialty practice, and the performance of the clinic was evaluated against a contemporary cohort. Quantitative and qualitative evaluation measures included team estimates of time spent on care-related tasks, physician rank of alignment of patient need with clinic design, major appointment changes, and nonvisit care tasks. Members of the care team also evaluated strengths, weaknesses, opportunities, and threats to the success of the clinic. RESULTS: The pilot clinic was operated from April 1, 2020, to April 30, 2021, and included 34 patients with suspected fibromyalgia/chronic abdominal pain. During the pilot period, physicians ranked the value of the virtual previsit consultations in providing care as 7.5 on a scale of 0 to 10 and reported an average of 50 minutes in preparation for the appointment, execution of the appointment, and postvisit documentation. We did not observe substantial differences in the number of added appointments or messages received within the patient portal when compared with a comparison cohort. Patients who participated in the combination nurse educator-led and digital education program provided positive feedback about their experience. CONCLUSION: Our clinic model provides a framework for the treatment of patients with debilitating centrally sensitized conditions and future expansion of virtual care delivery models to better meet patient care and educational needs.

Improving time to palliative care review with predictive modeling in an inpatient adult population: study protocol for a stepped-wedge, pragmatic randomized controlled trial.

BACKGROUND: Palliative care is a medical specialty centered on improving the quality of life (QOL) of patients with complex or life-threatening illnesses. The need for palliative care is increasing and with that the rigorous testing of triage tools that can be used quickly and reliably to identify patients that may benefit from palliative care. METHODS: To that aim, we will conduct a two-armed stepped-wedge cluster randomized trial rolled out to two inpatient hospitals to evaluate whether a machine learning algorithm accurately identifies patients who may benefit from a comprehensive review by a palliative care specialist and decreases time to receiving a palliative care consult in hospital. This is a single-center study which will be conducted from August 2019 to November 2020 at Saint Mary's Hospital & Methodist Hospital both within Mayo Clinic Rochester in Minnesota. Clusters will be nursing units which will be chosen to be a mix of complex patients from Cardiology, Critical Care, and Oncology and had previously established relationships with palliative medicine. The stepped wedge design will have 12 units allocated to a design matrix of 5 treatment wedges. Each wedge will last 75 days resulting in a study period of 12 months of recruitment unless otherwise specified. Data will be analyzed with Bayesian hierarchical models with credible intervals denoting statistical significance. DISCUSSION: This intervention offers a pragmatic approach to delivering specialty palliative care to hospital patients in need using machine learning, thereby leading to high value care and improved outcomes. It is not enough for AI to be utilized by simply publishing research showing predictive performance; clinical trials demonstrating better outcomes are critically needed. Furthermore, the deployment of an AI algorithm is a complex process that requires multiple teams with varying skill sets. To evaluate a deployed AI, a pragmatic clinical trial can accommodate the difficulties of clinical practice while retaining scientific rigor. TRIAL REGISTRATION: ClinicalTrials.gov NCT03976297 . Registered on 6 June 2019, prior to trial start.

Central Sensitization Symptom Severity and Patient-Provider Relationships in a Community Setting.

INTRODUCTION: Central sensitization syndromes (CSS) comprise an overlapping group of clinical conditions with the core feature of "pain arising as a direct consequence of a lesion or disease affecting the somatosensory system." Patients with CSS are known to have challenging interactions with healthcare providers contributing to psychological distress and increased healthcare utilization. CSS symptom severity has been associated with psychologic comorbidities, but little is known about how symptom severity relates to provider interactions. METHODS: We performed a cross-sectional survey among patients with CSS in our primary care practices to examine the relationship between CSS symptom severity and experiences with doctors. RESULTS: A total of 775 respondents completed the survey (775/5000; 15.5%) with 72% reporting high CSS symptom severity. About 44% of respondents had a prior diagnosis of fibromyalgia, 72% had migraines, and 28% had IBS. Patients with high CSS symptom severity were more likely to report that doctor(s) had often/always told them that they don't need treatment when they feel like they do (OR = 3.6, 95% CI 1.9-7.5), that doctor(s) often/always don't understand them (OR = 3.1, 95% CI 1.9-5.4), and that doctor(s) often/always seem annoyed with them when compared with respondents with low-moderate CSS symptom severity (OR = 4.8, 95% CI 2.2-12.5). Patients with high CSS symptom severity were at greater than 5 times odds of reporting being told that their symptoms were "all in their head" when compared to patients with low-moderate symptom severity (OR = 5.4, 95% CI 3.3-9.0). CONCLUSION: Patients with CSS spectrum disorders experience frequent pain and decreased quality of life. A high degree of CSS symptom severity is associated with negative experiences with healthcare providers, which deters the establishment of a positive provider-patient relationship. Further research is needed to help understand symptom severity in CSS and harness the power of the therapeutic alliance as a treatment modality.

Effect of Integrated Gastroenterology Specialists in a Primary Care Setting: a Retrospective Cohort Study.

BACKGROUND: Gastrointestinal (GI) complaints are common in primary care practices. The patient-centered medical home (PCMH) may improve coordination and collaboration by facilitating coordination across healthcare settings and within the community, enhancing communication between providers, and focusing on quality of care delivery. OBJECTIVE: To investigate the effect of integrated community gastroenterology specialists (ICS-GI) model within a large primary care practice. DESIGN: Retrospective cohort with propensity-matched historic controls. PATIENTS: We identified 265 patients who had a visit with one of our ICS-GI specialists and matched them (1:2) to 530 similar patients seen prior to the implementation of the ICS-GI model. MAIN MEASURES: Frequency of diagnostic testing for GI indications, visits to our outpatient GI referral practice, emergency department and hospital utilization, and time to access of specialty care for the whole population and by GI condition group. KEY RESULTS: Patients seen in our ICS-GI model had similar outpatient care utilization (OR = 1.0, 95% CI 0.7-1.4, p = 0.90), were more likely to have visits in primary care (OR OR=1.5, 95% CI 1.1-2.2, p = 0.02), and were less likely to have visits to our GI outpatient referral practice (OR = 0.3, 95% CI 0.2-0.7, p < 0.0001). Condition-specific analyses show that all GI conditions experienced decreased visits to the outpatient GI referral practice outside of patients with GI neoplasm. Populations did not differ in emergency department, hospital, or diagnostic utilization. CONCLUSIONS: We observed that an embedded specialist in primary care model is associated with improved care coordination without compromising patient safety. The PCMH could be extended to include subspecialty care.

Electronic Vaping Product Use among Young Adults Who Receive Care at a Major Medical Institution.

Background: National estimates of electronic vaping product (EVP) use exist, but little is known about young adult EVP users who interact with the healthcare setting. Methods: Cross-sectional survey of 18-25 year olds receiving care in our ambulatory medical practice. Population differences were evaluated with the chi square test reporting unadjusted odds ratios (ORs). Results: Response rate was 16.6% (n = 1,017/6,119). The prevalence of ever EVP use was 46.0% of whom 13.9% used every day. Each additional day of alcohol use (past 30 days) was associated with increased odds of being an EVP user (OR = 1.06, 95% CI 1.02-1.09), and cannabis use (past 30 days) was associated with a higher odds of being an EVP user compared to non-cannabis users (OR = 40.0, 95% CI 17.4 - 111.8). Observing a biological parent (OR = 2.89, 95% CI 1.98-4.24), step parent (OR = 2.03, 95% CI 1.02-4.19) and full sibling (OR = 2.31, 95% CI 1.78-3.00) using inhaled substances (past 30 days) was associated with increased odds of being an ever EVP user. Ever EVP users had lower odds than never users to report that EVPs with nicotine are "a little" or "a lot" more harmful than smoking "regular" tobacco cigarettes (OR = 0.53, 95% CI 0.37 - 0.76). Conclusion: Our survey is limited by a low response rate but confirms observed associations between EVP use and substance use and social influences. Our data also suggest that professionals should regularly screen for EVP use among young people, especially those with exposure to family members who used inhaled substances.

Changes in substance use among young adults during a respiratory disease pandemic.

BACKGROUND: News articles, commentaries, and opinion articles have suggested that ongoing social distancing measures coupled with economic challenges during COVID-19 may worsen stress, affective state, and substance use across the globe. We sought to advance our understanding of the differences between individuals who change their substance use patterns during a public health crisis and those who do not. METHODS: Cross-sectional survey of young adults (18-25 years of age) assessing respondent characteristics and vaping, tobacco, alcohol, and/or marijuana use. We calculated prevalence estimates, prevalence changes, and prevalence ratios with associated 95% confidence intervals and looked for differences with the chi-square test. RESULTS: Of the total sample, 53.2% (n = 542/1018) young adults reported vaping or using tobacco, alcohol, and/or marijuana. Among the 542 respondents reporting use, 34.3% reported a change in their use patterns. Among respondents reporting changes in substance use patterns during the pandemic (n = 186), 68.8% reported an increase in alcohol use, 44.0% reported a decrease in vaping product use, and 47.3% reported a decrease in tobacco product use due to COVID-19. Substance use changed significantly for respondents with increasing degree of loneliness (continuous loneliness score: prevalence ratio = 1.12, 95% confidence interval = 1.01-1.25), anxiety (prevalence ratio = 1.45, 95% confidence interval = 1.14-1.85), and depression (prevalence ratio = 1.44, 95% confidence interval = 1.13-1.82). CONCLUSION: Self-reported substance use among young adults was observed to change during a pandemic, and the degree of loneliness appears to impact these changes. Innovative strategies are needed to address loneliness, anxiety, depression, and substance use during global health crises that impact social contact.

A survey of the attitudes, beliefs and knowledge about medical cannabis among primary care providers.

BACKGROUND: Healthcare providers play a critical role in facilitating patient access to medical cannabis. However, previous surveys suggest only a minority of providers believe that medical cannabis confers benefits to patients. Significant new knowledge about the potential benefits and harms of medical cannabis has recently emerged. Understanding current attitudes and beliefs of providers may provide insight into the ongoing challenges they face as states expand access to medical cannabis. METHODS: We conducted an electronic survey of primary care providers in a large Minnesota-based healthcare system between January 23 and February 5, 2018. We obtained information about provider characteristics, attitudes and beliefs about medical cannabis, provider comfort level in answering patient questions about medical cannabis, and whether providers were interested in receiving additional education. RESULTS: Sixty-two providers completed the survey (response rate 31%; 62/199). Seventy-six percent of respondents were physicians and the average age was 46.3 years. A majority of providers believed ("strongly agree" or "somewhat agree") that medical cannabis was a legitimate medical therapy (58.1%) and 38.7% believed that providers should be offering to patients for managing medical conditions. A majority (> 50%) of providers believed that medical cannabis was helpful for treating the qualifying medical conditions of cancer, terminal illness, and intractable pain. A majority of providers did not know if medical cannabis was effective for managing nearly one-half of the other state designated qualifying medical conditions. Few believed that medical cannabis improved quality of life domains. Over one-third of providers believed that medical cannabis interacted with medical therapies. One-half of providers were not ready to or did not want to answer patient questions about medical cannabis, and the majority of providers wanted to learn more about it. CONCLUSIONS: Healthcare providers generally believe that medical cannabis is a legitimate medical therapy. Provider knowledge gaps about the effectiveness of medical cannabis for state designated qualifying conditions need to be addressed, and accurate information about the potential for drug interactions needs to be disseminated to address provider concerns. Clinical trial data about how medical cannabis improves patient quality of life domains is desperately needed as this information can impact clinical decision-making.

Risk Factors Associated With Health Care Utilization and Costs of Patients Undergoing Lower Extremity Joint Replacement.

BACKGROUND: The Comprehensive Care for Joint Replacement program implemented by the Centers for Medicare and Medicaid Services did not incorporate risk adjustment for lower extremity joint replacement (LEJR). Lack of adjustment places hospitals at financial risk and creates incentives for adverse patient selection. OBJECTIVE: To identify patient-level risk factors associated with health care utilization and costs of patients undergoing LEJR. METHODS: A comprehensive search of research databases from January 1, 1990, through January 31, 2016, was conducted. The databases included Ovid MEDLINE In-Process & Other Non-Indexed Citations, Ovid MEDLINE, Ovid EMBASE, Ovid Cochrane Central Register of Controlled Trials, Ovid Cochrane Database of Systematic Reviews, and SCOPUS and is reported according to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) statement. The search identified 2020 studies. Eligible studies focused on primary unilateral and bilateral LEJR. Independent reviewers determined study eligibility and extracted utilization and cost data. RESULTS: Seventy-nine of 330 studies (24%) were included and were abstracted for analysis. Comorbidities, age, disease severity, and obesity were associated with increased costs. Increased number of comorbidities and age, presence of specific comorbidities, lower socioeconomic status, and female sex had evidence of increased length of stay. We found no significant association between indication for surgery and the likelihood of readmission. CONCLUSION: Developing a risk adjustment model for LEJR that incorporates clinical variables may serve to reduce the likelihood of adverse patient selection and enhance appropriate reimbursement aligned with procedural complexity.

Controlled Substance Agreements for Opioids in a Primary Care Practice.

BACKGROUND: Opioids are widely prescribed for chronic non cancer pain (CNCP). Controlled substance agreements (CSAs) are intended to increase adherence and mitigate risk with opioid prescribing. We evaluated the demographic characteristics of and opioid dosing for patients with CNCP enrolled in CSAs in a primary care practice. METHODS: We conducted a retrospective cohort study of 1066 patients enrolled in CSAs between May 9, 2013 and August 15, 2016 for CNCP in a Midwest primary care practice. RESULTS: Patients were prescribed an average of 40.8 (SD ± 57.0) morphine milligram equivalents per day (MME/day), and 21.5% of patients were receiving ≥50 MME/day and 9.7% were receiving ≥90 MME/day. Patients who were younger in age (≥ 65 vs. < 65 years, P < 0.0001), male gender (P = 0.0001), and used tobacco (P = 0.0002) received significantly higher MME/day. Patients with more co-morbidities (Charlson Comorbidity Index, CCI) received higher MME/day (CCI > 3 vs. CCI ≤ 3, P = 0.03), and reported higher average pain (CCI > 3 mean 5.8 [SD ± 2.1] vs. CCI ≤ 3 mean 5.3 [SD ± 2.0], P = 0.0011). Patients on an identified tapering plan (6.9%) had higher MME/day than patients not on a tapering plan (P = 0.0002). CONCLUSIONS: CSAs present an opportunity to engage patients taking higher doses of opioids in discussions about opioid safety, appropriate dosing and tapering. CSAs could be leveraged to develop a population health management approach to the care of patients with CNCP.

Nonhematologic toxicity of imatinib mesylate in pediatric patients with chronic myelogenous leukemia: a predominance of musculoskeletal pain.

Therapy with the tyrosine kinase inhibitor imatinib mesylate has become standard initial treatment for adult and pediatric patients with chronic myelogenous leukemia. Long-term follow-up data are now available in the adult population, and the toxicity profile of imatinib mesylate among adults has been extensively studied and reported. Despite its increasing use in the pediatric population, there are limited data regarding adverse event profiles of imatinib mesylate in children, and few reports exist in the literature focusing on nonhematologic toxicity in this population. We reviewed our institutional experience with imatinib therapy for chronic myelogenous leukemia over an 8-year period of time. Nine pediatric patients began therapy with imatinib mesylate and were included in this review. We reviewed the occurrence of nonhematologic toxicity in this cohort and the impact of that toxicity on continuation of therapy. Eight patients experienced nonhematologic toxicity, including nausea/vomiting (44.4%) and musculoskeletal pain (88.9%). Three patients (33.3%) required discontinuation of imatinib therapy due to grade 3/4 musculoskeletal pain, a rate that is significantly higher than that seen in the adult population. As imatinib therapy becomes increasingly widespread in the treatment of pediatric malignancies, there may be different patterns of clinically significant nonhematologic toxicity, including higher grade musculoskeletal pain.

Totally Thoracoscopic Surgical Ablation or Catheter Ablation of Atrial Fibrillation: A Systematic Review and Preliminary Meta-Analysis.

This article provides results of a preliminary meta-analysis of the stand-alone atrial fibrillation (AF) surgical publications from 2009 to 2011. In 6 studies with postoperative freedom from AF as primary end point, the meta-analysis indicated an overall success rate of 84% (95% confidence interval [CI], 80.0-88.0). For the 7 studies with the primary end point of postoperative return to normal sinus rhythm, the success rate was 83% (95% CI, 79.0-87.0). These data are compared with 3 comprehensive meta-analyses of catheter ablation. Based on comparison, it is recommended that initial treatment of long-standing persistent atrial fibrillation be minimal access surgery.