Abstract Background Fibromyalgia (FM) is a chronic pain disorder associated with financial burden, decreased work productivity and absenteeism. Occupational stressors and specific employment factors may contribute to the severity of FM. Aims To determine if occupation type or employment status correlates with FM diagnostic and severity parameters, as assessed via validated instruments including tender points (TP), Widespread Pain Index (WPI), Symptom Severity (SS) and pain regions. Methods We performed a cross-sectional study of 200 adult patients diagnosed with FM at a single-centre FM clinic. Demographic and clinical data were extracted from the electronic medical records. Occupations were manually grouped in an iterative modified-Delphi approach and participants were grouped by employment status (Working, Not Working/Disabled or Retired) for analysis. Results In our cohort, 61% were employed and 24% were not working/disabled, while the remainder were students, homemakers or retired. SS score was significantly higher (P < 0.001) in not working/disabled patients compared to those employed. Business owners had the lowest TP count (median = 14) and the lowest median SS score (median = 7). WPI was highest for Others (Arts/Entertainment, Driver/Delivery and Housekeeper/Custodian workers; median=16) and the lowest for Retail/Sales/Wait Staff (median = 11). Conclusions Work-related factors, occupation type and employment status correlate with diagnostic and severity parameters of FM. Employed participants had significantly lower SS scores suggesting that work loss correlates with SS. Participants employed in entry-level jobs or jobs with higher physical or financial stressors may experience greater FM symptoms. Further studies are required to explore work-related factors and their impact on the diagnostic and severity parameters of FM.
Comorbid extra‐intestinal central sensitization conditions worsen irritable bowel syndrome in primary care patients
AbstractBackgroundIrritable 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.MethodsWe 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 ResultsSeven 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 & InferencesPatients 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.
Patient Perspectives on Anti-spike Monoclonal Antibody Therapy for Mild to Moderate Coronavirus Disease-2019
Anti-spike monoclonal antibodies emerged as effective early treatment of high-risk individuals with mild-to-moderate COVID-19. Although their clinical and safety outcomes have been reported, patient perspectives of these experimental therapies have not been evaluated. In this survey participated by 644/2412 (26.7% response) individuals evaluated for anti-spike monoclonal antibody therapies, the majority of 523 patients who received the antibody infusion were very satisfied with their overall patient experience, the quality of care provided, and various aspects of medical care. They voiced satisfaction with the communication with providers before and during treatment, including education provided about monoclonal antibody treatment, the potential benefits and adverse effects, detailed instructions on the process of infusion, and safety protocols employed at the infusion facilities. Nearly a quarter (23.6%) of 121 patients who declined therapy indicated they would accept treatment should it be offered again. These patient perspectives may be used to guide healthcare facilities and providers in optimizing the care provided to high-risk outpatients with COVID-19.
Provider Perspectives and Clinical Outcomes with Inpatient Telenephrology
Background and objectives Despite the dramatic increase in the provision of virtual nephrology care, only anecdotal reports of outcomes without comparators to usual care exist in the literature. This study aimed to provide objective determination of clinical noninferiority of hybrid (telenephrology plus face-to-face) versus standard (face-to-face) inpatient nephrology care. Design, setting, participants, & measurements This retrospective study compares objective outcomes in patients who received inpatient hybrid care versus standard nephrology care at two Mayo Clinic Health System community hospitals. Outcomes were then additionally compared with those patients receiving care at another Mayo Clinic Health System site where only standard care is available. Hospitalized adults who had nephrology consults from March 1, 2020 to February 28, 2021 were considered. Regression was used to assess 30-day mortality, length of hospitalization, readmissions, odds of being prescribed dialysis, and hospital transfers. Sensitivity analysis was performed using patients who had ≥50% of their care encounters via telenephrology. Structured surveys were used to understand the perspectives of non-nephrology hospital providers and telenephrologists. Results In total, 850 patients were included. Measured outcomes that included the number of hospital transfers (odds ratio, 1.19; 95% confidence interval, 0.37 to 3.82) and 30-day readmissions (odds ratio, 0.97; 95% confidence interval, 0.84 to 1.06), among others, did not differ significantly between controls and patients in the general cohort. Telenephrologists ( n =11) preferred video consults (82%) to phone for communication. More than half (64%) of telenephrologists spent less time on telenephrology compared with standard care. Non-nephrology hospital providers ( n =21) were very satisfied (48%) and satisfied (29%) with telenephrology response time and felt telenephrology was as safe as standard care (67%), while providing them enough information to make patient care decisions (76%). Conclusions Outcomes for in-hospital nephrology consults were not significantly different comparing hybrid care versus standard care. Non-nephrology hospital providers and telenephrologists had favorable opinions of telenephrology and most perceived it is as safe and effective as standard care. Podcast This article contains a podcast at https://www.asn-online.org/media/podcast/CJASN/2022_04_11_CJN13441021.mp3
Abstract Background Bamlanivimab and casirivimab-imdevimab are authorized for treatment of mild to moderate coronavirus disease 2019 (COVID-19) in high-risk patients. We compared the outcomes of patients who received these therapies to identify factors associated with hospitalization and other clinical outcomes. Methods Adult patients who received monoclonal antibody from 19 November 2020 to 11 February 2021 were selected and divided into those who received bamlanivimab (n = 2747) and casirivimab-imdevimab (n = 849). The 28-day all-cause and COVID-19–related hospitalizations were compared between the groups. Results The population included 3596 patients; the median age was 62 years, and 50% were female. All had ≥1 medical comorbidity; 55% had multiple comorbidities. All-cause and COVID-19–related hospitalization rates at 28 days were 3.98% and 2.56%, respectively. After adjusting for medical comorbidities, there was no significant difference in all-cause and COVID-19–related hospitalization rates between bamlanivimab and casirivimab-imdevimab (adjusted hazard ratios [95% confidence interval], 1.4 [.9–2.2] and 1.6 [.8–2.7], respectively). Chronic kidney, respiratory and cardiovascular diseases, and immunocompromised status were associated with higher likelihood of hospitalization. Conclusions This observational study on the use of bamlanivimab and casirivimab-imdevimab in high-risk patients showed similarly low rates of hospitalization. The number and type of medical comorbidities are associated with hospitalizations after monoclonal antibody treatment.
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.
Influence of Social and Cultural Factors on the Decision to Consent for Monoclonal Antibody Treatment among High-Risk Patients with Mild-Moderate COVID-19
Background The clinical outcomes of patients who decline anti-spike monoclonal antibody therapies for coronavirus disease-2019 (COVID-19) is not known. Factors associated with the decision to accept or decline the offer for anti-spike monoclonal antibody therapies are not established. This study aimed to identify factors impacting the decision to consent for monoclonal antibody therapies and assess the differences in clinical outcomes of patients who accepted compared to those who declined these therapies. Methods This retrospective cohort study enrolled 2820 adult patients who were offered monoclonal antibody therapies, bamlanivimab and casirivimab-imdevimab, for COVID-19 at Mayo Clinic in the Midwest between 11/19/2020 and 12/31/2020. The primary endpoint is the decision to accept or decline monoclonal antibody treatment. Secondary endpoints were patient-level factors that could have impacted the decision to accept treatment (age, gender, race, ethnicity, primary language spoken, and medical comorbidities). The main clinical endpoint was hospitalization within 28 days of COVID-19 diagnosis. Results 59.1% (n = 1669) chose to accept monoclonal antibody therapy, and 40.9% (n = 1151) chose to decline the offer for treatment. Patients were more likely to accept treatment if they were non-Hispanic White, English speaking, identified a spouse or life partner, had a religious affiliation, and possessed more medical comorbidities. Overall, 28-day hospitalization rate was 2.6% (n = 72/2820) and was higher among those who declined (3.3%) than those who accepted monoclonal antibody therapy (2.0%; Rate Ratio = 0.62, 95% Confidence Interval, 0.39-0.98). Conclusions Despite having more comorbidities, patients who accepted monoclonal antibody treatments had a lower rate of hospitalization compared to patients who declined treatment. Several social and cultural factors were associated with the decision to decline therapy, including race, language, ethnicity, and lack of social support. These findings can inform public health efforts to reduce social disparities in the treatment of COVID-19 and increase utilization of monoclonal antibody therapies in high risk populations.
Improving Time to Palliative Care Review With Predictive Modeling: Study Protocol for a Stepped-wedge, Pragmatic Randomized Controlled Trial
Abstract 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, Mayo Clinic, Rochester, 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 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 whilst retaining scientific rigor.Trial registration NCT03976297 (ClinicalTrials.gov), registered on June 6, 2019 prior to trial start.