Publications by authors named "Janis E Blair"

105 Publications

Mild to moderate COVID-19 illness in adult outpatients: Characteristics, symptoms, and outcomes in the first 4 weeks of illness.

Medicine (Baltimore) 2021 Jun;100(24):e26371

Division of Infectious Diseases.

Abstract: Most patients with coronavirus disease 2019 (COVID-19) have mild to moderate illness not requiring hospitalization. However, no study has detailed the evolution of symptoms in the first month of illness.At our institution, we conducted remote (telephone and video) visits for all adult outpatients diagnosed with COVID-19 within 24 h of a positive nasopharyngeal polymerase chain test for SARS-CoV-2. We repeated regular video visits at 7, 14, and 28 days after the positive test, retrospectively reviewed the prospective data collected in the remote visits, and constructed a week by week profile of clinical illness, through week 4 of illness.We reviewed the courses of 458 symptomatic patients diagnosed between March 12, 2020, and June 22, 2020, and characterized their weekly courses. Common initial symptoms included fever, headache, cough, and chest pain, which frequently persisted through week 3 or longer. Upper respiratory or gastrointestinal symptoms were much shorter lived, present primarily in week 1. Anosmia/ageusia peaked in weeks 2 to 3. Emergency department visits were frequent, with 128 visits in the 423 patients who were not hospitalized and 48 visits among the 35 outpatients (7.6%) who were eventually hospitalized (2 subsequently died). By the fourth week, 28.9% said their illness had completely resolved. After the 4-week follow up, 20 (4.7%) of the 423 nonhospitalized patients had further medical evaluation and management for subacute or chronic COVID-19 symptoms.Mild to moderate outpatient COVID-19 is a prolonged illness, with evolving symptoms commonly lasting into the fourth week of illness.
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http://dx.doi.org/10.1097/MD.0000000000026371DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8213280PMC
June 2021

COVID-19 Dysautonomia.

Front Neurol 2021 13;12:624968. Epub 2021 Apr 13.

Department of Neurology, Mayo Clinic, Scottsdale, AZ, United States.

To report a case series of dysautonomia associated with COVID-19 infection. This is a retrospective review of patients evaluated in the autonomic clinic at our institution with suspected signs and symptoms of dysautonomia who underwent formal evaluation, including autonomic testing. Six patients were identified with signs and symptoms suggestive of dysautonomia who underwent autonomic testing. All patients had symptoms typical of COVID-19 infection, though none were hospitalized for these or other symptoms. All patients reported symptoms of postural lightheadedness and near-syncope, fatigue, and activity intolerance. Five patients reported the onset of autonomic symptoms concomitant with other COVID-19 symptoms, with the other patient reporting symptom onset 6 weeks following initial COVID-19 symptoms. Autonomic testing demonstrated an excessive postural tachycardia in 4 patients, a hypertensive response with head-up tilt in 3 patients, orthostatic hypotension in 1 patient, and sudomotor impairment in 1 of the patients with excessive postural tachycardia. We present clinical features and results of autonomic testing in 6 patients with a history COVID-19 infection. While all patients reported typical features of orthostatic intolerance, fatigue, and activity intolerance, the results of autonomic testing were heterogenous, with orthostatic hypotension in 1 patient, excessive postural tachycardia typical of postural tachycardia syndrome in 4 patients, and postural hypertension in 3 patients.
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http://dx.doi.org/10.3389/fneur.2021.624968DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8076737PMC
April 2021

Coccidioidomycosis in Allogeneic Stem Cell Transplant Recipients: Case Series and Review of the Literature.

J Fungi (Basel) 2021 Apr 27;7(5). Epub 2021 Apr 27.

Division of Infectious Diseases, Mayo Clinic, Phoenix, AZ 85054, USA.

is an endemic fungus of the Southwest United States that causes the disease coccidioidomycosis. Immunocompromised persons are at increased risk for severe infection and dissemination. One such population is allogeneic bone marrow transplant (allo-HCT) recipients, but accounts of coccidioidal infection in these patients have rarely been documented. We present two cases of in allo-HCT recipients with good outcomes: one patient who developed pulmonary coccidioidomycosis in the late post-engraftment phase and another with known controlled disseminated infection at the time of transplant. A review of the literature identified 19 allo-HCT recipients with coccidioidomycosis. Due to the limited published literature, no guidelines have yet been established regarding optimal prophylaxis and treatment of infection in allo-HCT recipients. Candidates for transplantation should undergo a rigorous pre-transplant assessment to identify evidence of prior or active coccidioidomycosis. In our experience, patients who visit or live in -endemic areas should receive primary prophylaxis for at least the first 100 days post-transplant, and duration should be extended as long as the patient remains on immunosuppression. Those with prior infection should receive secondary prophylaxis while immunosuppressed. Patients with active infection should have treatment and stabilization of infection and continue anti-fungal treatment through immunosuppression.
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http://dx.doi.org/10.3390/jof7050339DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8145758PMC
April 2021

Program and patient characteristics for the United States Expanded Access Program to COVID-19 convalescent plasma.

medRxiv 2021 Apr 10. Epub 2021 Apr 10.

Background: The United States (US) Expanded Access Program (EAP) to COVID-19 convalescent plasma was initiated in response to the rapid spread of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the causative agent of coronavirus disease-2019 (COVID-19). While randomized clinical trials were in various stages of development and enrollment, there was an urgent need for widespread access to potential therapeutic agents particularly for vulnerable racial and ethnic minority populations who were disproportionately affected by the pandemic. The objective of this study is to report on the demographic, geographic, and chronological access to COVID-19 convalescent plasma in the US via the EAP.

Methods And Findings: Mayo Clinic served as the central IRB for all participating facilities and any US physician could participate as local physician-principal investigator. Registration occurred through the EAP central website. Blood banks rapidly developed logistics to provide convalescent plasma to hospitalized patients with COVID-19. Demographic and clinical characteristics of all enrolled patients in the EAP were summarized. Temporal trends in access to COVID-19 convalescent plasma were investigated by comparing daily and weekly changes in EAP enrollment in response to changes in infection rate on a state level. Geographical analyses on access to convalescent plasma included assessing EAP enrollment in all national hospital referral regions as well as assessing enrollment in metropolitan and less populated areas which did not have access to COVID-19 clinical trials.From April 3 to August 23, 2020, 105,717 hospitalized patients with severe or life-threatening COVID-19 were enrolled in the EAP. A majority of patients were older than 60 years of age (57.8%), male (58.4%), and overweight or obese (83.8%). There was substantial inclusion of minorities and underserved populations, including 46.4% of patients with a race other than White, and 37.2% of patients were of Hispanic ethnicity. Severe or life-threatening COVID-19 was present in 61.8% of patients and 18.9% of patients were mechanically ventilated at time of convalescent plasma infusion. Chronologically and geographically, increases in enrollment in the EAP closely followed confirmed infections across all 50 states. Nearly all national hospital referral regions enrolled patients in the EAP, including both in metropolitan and less populated areas.

Conclusions: The EAP successfully provided widespread access to COVID-19 convalescent plasma in all 50 states, including for underserved racial and ethnic minority populations. The efficient study design of the EAP may serve as an example framework for future efforts when broad access to a treatment is needed in response to a dynamic disease affecting demographic groups and areas historically underrepresented in clinical studies.
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http://dx.doi.org/10.1101/2021.04.08.21255115DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8043472PMC
April 2021

Cavitary Coccidioidomycosis: Impact of azole antifungal therapy.

Med Mycol 2021 Mar 16. Epub 2021 Mar 16.

Division of Infectious Diseases, Department of Internal Medicine, Mayo Clinic Hospital, Phoenix, Arizona, 85054, USA.

Approximately 5 to 15% of patients with pulmonary coccidioidomycosis subsequently develop pulmonary cavities. These cavities may resolve spontaneously over a number of years; however, some cavities never close, and a small proportion causes complications such as hemorrhage, pneumothorax or empyema. The impact of azole antifungal treatment on coccidioidal cavities has not been studied. Because azoles are a common treatment for symptomatic pulmonary coccidioidomycosis, we aimed to assess the impact of azole therapy on cavity closure. From January 1, 2004, through December 31, 2014, we retrospectively identified 313 patients with cavitary coccidioidomycosis and excluded 42 who had the cavity removed surgically, leaving 271 data sets available for study. Of the 271 patients, 221 (81.5%) received azole therapy during 5-year follow-up; 50 patients did not receive antifungal treatment. Among the 271 patients, cavities closed in 38 (14.0%). Statistical modeling showed that cavities were more likely to close in patients in the treated group than in the nontreated group (hazard ratio, 2.14 [95% CI: 1.45-5.66]). Cavities were less likely to close in active smokers than nonsmokers (11/41 [26.8%] vs 97/182 [53.3%]; P = 0.002) or in persons with than without diabetes (27/74 [36.5%] vs 81/149 [54.4%]; P = 0.01).We did not find an association between cavity size and closure. Our findings provide rationale for further study of treatment protocols in this subset of patients with coccidioidomycosis.

Lay Summary: Coccidioidomycosis, known as valley fever, is a fungal infection that infrequently causes cavities to form in the lungs, which potentially results in long-term lung symptoms. We learned that cavities closed more often in persons who received antifungal drugs, but most cavities never closed completely.
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http://dx.doi.org/10.1093/mmy/myab011DOI Listing
March 2021

Convalescent Plasma Antibody Levels and the Risk of Death from Covid-19.

N Engl J Med 2021 03 13;384(11):1015-1027. Epub 2021 Jan 13.

From the Departments of Anesthesiology and Perioperative Medicine (M.J.J., J.W.S., S.A.K., C.C.W., A.M.K., M.A.S., J.C.D.S., S.E.B., J.R.A.S., V.H., A.J.C., J.G.R., K.J.A., M.N.P.V., J.J.D., R.J.R.), Laboratory Medicine and Pathology (J.R.M., E.S.T., C.M.B., J.L.W., J.R.S.), and Cardiovascular Medicine (R.F.R., K.F.L., R.S.W.), the Human Research Protection Program (R.S.W.), and the Department of Internal Medicine, Division of Pulmonary and Critical Care Medicine (P.R.B.), Mayo Clinic, Rochester, MN; the Departments of Health Sciences Research (R.E.C., P.W.J., E.R.L., D.O.H.) and Cardiovascular Medicine (K.A.B., E.R.W., D.F.), Mayo Clinic, Jacksonville, FL; the Department of Health Sciences Research (K.L.K., M.R.B.) and the Department of Internal Medicine, Division of Infectious Diseases (J.E.B.), Mayo Clinic, Phoenix, AZ; the Department of Anesthesiology, Cooper Medical School of Rowan University, Cooper University Health Care, Camden, NJ (N.H.); the Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring (N.C.V., P.M.), and the Department of Molecular Microbiology and Immunology, Johns Hopkins Bloomberg School of Public Health, Baltimore (A.C.) - both in Maryland; and the Departments of Epidemiology and Biostatistics and of Pediatrics and Human Development, College of Human Medicine, Michigan State University, East Lansing (N.S.P.).

Background: Convalescent plasma has been widely used to treat coronavirus disease 2019 (Covid-19) under the presumption that such plasma contains potentially therapeutic antibodies to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) that can be passively transferred to the plasma recipient. Whether convalescent plasma with high antibody levels rather than low antibody levels is associated with a lower risk of death is unknown.

Methods: In a retrospective study based on a U.S. national registry, we determined the anti-SARS-CoV-2 IgG antibody levels in convalescent plasma used to treat hospitalized adults with Covid-19. The primary outcome was death within 30 days after plasma transfusion. Patients who were enrolled through July 4, 2020, and for whom data on anti-SARS-CoV-2 antibody levels in plasma transfusions and on 30-day mortality were available were included in the analysis.

Results: Of the 3082 patients included in this analysis, death within 30 days after plasma transfusion occurred in 115 of 515 patients (22.3%) in the high-titer group, 549 of 2006 patients (27.4%) in the medium-titer group, and 166 of 561 patients (29.6%) in the low-titer group. The association of anti-SARS-CoV-2 antibody levels with the risk of death from Covid-19 was moderated by mechanical ventilation status. A lower risk of death within 30 days in the high-titer group than in the low-titer group was observed among patients who had not received mechanical ventilation before transfusion (relative risk, 0.66; 95% confidence interval [CI], 0.48 to 0.91), and no effect on the risk of death was observed among patients who had received mechanical ventilation (relative risk, 1.02; 95% CI, 0.78 to 1.32).

Conclusions: Among patients hospitalized with Covid-19 who were not receiving mechanical ventilation, transfusion of plasma with higher anti-SARS-CoV-2 IgG antibody levels was associated with a lower risk of death than transfusion of plasma with lower antibody levels. (Funded by the Department of Health and Human Services and others; ClinicalTrials.gov number, NCT04338360.).
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http://dx.doi.org/10.1056/NEJMoa2031893DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7821984PMC
March 2021

Coccidioidomycosis in patients with various inflammatory disorders treated with tumor necrosis factor α inhibitors.

Med Mycol 2021 Jul;59(7):720-727

Division of Infectious Diseases, Mayo Clinic Hospital, Phoenix, Arizona.

Coccidioides fungi are found primarily in the southwestern United States and are the cause of coccidioidomycosis. Tumor necrosis factor α inhibitors (TNFIs) are therapies for autoimmune and inflammatory conditions; their association with coccidioidomycosis is not well characterized. We aimed to determine the prevalence and characteristics of coccidioidomycosis among TNFI recipients with different inflammatory disorders at a tertiary care center. We retrospectively reviewed the electronic health records of patients at our institution from April 4, 2010 to December 17, 2017, who received TNFIs (infliximab, etanercept, adalimumab, certolizumab pegol, or golimumab) and had positive culture, pathologic, and/or serologic results for coccidioidomycosis. Among 1770 patients identified who received TNFIs, 49 (2.8%) had proven or probable coccidioidomycosis. Of these 49, 28 (57%) were men, 47 (96%) were White, and 42 (86%) had pulmonary coccidioidomycosis. The most common TNFIs used were adalimumab, infliximab, and etanercept. Coccidioidomycosis was identified in 25 of 794 patients with rheumatologic disorders (3.1%), 18 of 783 patients with inflammatory bowel disease (IBD) (2.3%), and six of 193 patients with dermatologic disorders (3.1%) (P = .34). There was no difference in coccidioidal infections among recipients of any particular TNFI agents. A minority of patients (7/49, 14%) had an extrapulmonary infection, and the majority of these (6/7) had IBD. Our study shows a low prevalence of coccidioidomycosis in TNFI recipients, even within the Coccidioides-endemic area. Persons with IBD were disproportionately represented among those with extrapulmonary coccidioidomycosis. Treatment with azoles was effective.

Lay Summary: Among 1770 patients who received tumor necrosis factor α inhibitors, 49 (2.8%) had newly acquired coccidioidomycosis over a 7-year period. Dissemination occurred in 14.3%, but disproportionately among those with underlying inflammatory bowel disease. All patients recovered with medical management.
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http://dx.doi.org/10.1093/mmy/myaa109DOI Listing
July 2021

Safety Update: COVID-19 Convalescent Plasma in 20,000 Hospitalized Patients.

Mayo Clin Proc 2020 09 19;95(9):1888-1897. Epub 2020 Jul 19.

Department of Anesthesiology, Cooper Medical School of Rowan University, Cooper University Health Care, Camden, NJ.

Objective: To provide an update on key safety metrics after transfusion of convalescent plasma in hospitalized coronavirus 2019 (COVID-19) patients, having previously demonstrated safety in 5000 hospitalized patients.

Patients And Methods: From April 3 to June 2, 2020, the US Food and Drug Administration Expanded Access Program for COVID-19 convalescent plasma transfused a convenience sample of 20,000 hospitalized patients with COVID-19 convalescent plasma.

Results: The incidence of all serious adverse events was low; these included transfusion reactions (n=78; <1%), thromboembolic or thrombotic events (n=113; <1%), and cardiac events (n=677, ~3%). Notably, the vast majority of the thromboembolic or thrombotic events (n=75) and cardiac events (n=597) were judged to be unrelated to the plasma transfusion per se. The 7-day mortality rate was 13.0% (12.5%, 13.4%), and was higher among more critically ill patients relative to less ill counterparts, including patients admitted to the intensive care unit versus those not admitted (15.6 vs 9.3%), mechanically ventilated versus not ventilated (18.3% vs 9.9%), and with septic shock or multiple organ dysfunction/failure versus those without dysfunction/failure (21.7% vs 11.5%).

Conclusion: These updated data provide robust evidence that transfusion of convalescent plasma is safe in hospitalized patients with COVID-19, and support the notion that earlier administration of plasma within the clinical course of COVID-19 is more likely to reduce mortality.
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http://dx.doi.org/10.1016/j.mayocp.2020.06.028DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7368917PMC
September 2020

Effect of Convalescent Plasma on Mortality among Hospitalized Patients with COVID-19: Initial Three-Month Experience.

medRxiv 2020 Aug 12. Epub 2020 Aug 12.

Importance: Passive antibody transfer is a longstanding treatment strategy for infectious diseases that involve the respiratory system. In this context, human convalescent plasma has been used to treat coronavirus disease 2019 (COVID-19), but the efficacy remains uncertain.

Objective: To explore potential signals of efficacy of COVID-19 convalescent plasma.

Design: Open-label, Expanded Access Program (EAP) for the treatment of COVID-19 patients with human convalescent plasma.

Setting: Multicenter, including 2,807 acute care facilities in the US and territories.

Participants: Adult participants enrolled and transfused under the purview of the US Convalescent Plasma EAP program between April 4 and July 4, 2020 who were hospitalized with (or at risk of) severe or life threatening acute COVID-19 respiratory syndrome.

Intervention: Transfusion of at least one unit of human COVID-19 convalescent plasma using standard transfusion guidelines at any time during hospitalization. Convalescent plasma was donated by recently-recovered COVID-19 survivors, and the antibody levels in the units collected were unknown at the time of transfusion. Main Outcomes and Measures: Seven and thirty-day mortality.

Results: The 35,322 transfused patients had heterogeneous demographic and clinical characteristics. This cohort included a high proportion of critically-ill patients, with 52.3% in the intensive care unit (ICU) and 27.5% receiving mechanical ventilation at the time of plasma transfusion. The seven-day mortality rate was 8.7% [95% CI 8.3%-9.2%] in patients transfused within 3 days of COVID-19 diagnosis but 11.9% [11.4%-12.2%] in patients transfused 4 or more days after diagnosis (p<0.001). Similar findings were observed in 30-day mortality (21.6% vs. 26.7%, p<0.0001). Importantly, a gradient of mortality was seen in relation to IgG antibody levels in the transfused plasma. For patients who received high IgG plasma (>18.45 S/Co), seven-day mortality was 8.9% (6.8%, 11.7%); for recipients of medium IgG plasma (4.62 to 18.45 S/Co) mortality was 11.6% (10.3%, 13.1%); and for recipients of low IgG plasma (<4.62 S/Co) mortality was 13.7% (11.1%, 16.8%) (p=0.048). This unadjusted dose-response relationship with IgG was also observed in thirty-day mortality (p=0.021). The pooled relative risk of mortality among patients transfused with high antibody level plasma units was 0.65 [0.47-0.92] for 7 days and 0.77 [0.63-0.94] for 30 days compared to low antibody level plasma units.

Conclusions And Relevance: The relationships between reduced mortality and both earlier time to transfusion and higher antibody levels provide signatures of efficacy for convalescent plasma in the treatment of hospitalized COVID-19 patients. This information may be informative for the treatment of COVID-19 and design of randomized clinical trials involving convalescent plasma.

Trial Registration: ClinicalTrials.gov Identifier: NCT04338360.
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http://dx.doi.org/10.1101/2020.08.12.20169359DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7430623PMC
August 2020

Coccidioidomycosis in Patients Treated With Ruxolitinib.

Open Forum Infect Dis 2020 Jun 19;7(6):ofaa167. Epub 2020 May 19.

Division of Infectious Diseases, Mayo Clinic in Arizona, Phoenix, Arizona, USA.

We report 8 cases of coccidioidomycosis associated with ruxolitinib treatment. Among 135 patients living in the coccidioidal-endemic region receiving ruxolitinib, 5 cases were diagnosed after starting and 4 had extrathoracic dissemination. Periodic serological screening while on ruxolitinib is warranted for patients residing in the coccidioidal-endemic region.
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http://dx.doi.org/10.1093/ofid/ofaa167DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7284005PMC
June 2020

Early safety indicators of COVID-19 convalescent plasma in 5000 patients.

J Clin Invest 2020 09;130(9):4791-4797

Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, Minnesota, USA.

BACKGROUNDConvalescent plasma is the only antibody-based therapy currently available for patients with coronavirus disease 2019 (COVID-19). It has robust historical precedence and sound biological plausibility. Although promising, convalescent plasma has not yet been shown to be safe as a treatment for COVID-19.METHODSThus, we analyzed key safety metrics after transfusion of ABO-compatible human COVID-19 convalescent plasma in 5000 hospitalized adults with severe or life-threatening COVID-19, with 66% in the intensive care unit, as part of the US FDA expanded access program for COVID-19 convalescent plasma.RESULTSThe incidence of all serious adverse events (SAEs), including mortality rate (0.3%), in the first 4 hours after transfusion was <1%. Of the 36 reported SAEs, there were 25 reported incidences of related SAEs, including mortality (n = 4), transfusion-associated circulatory overload (n = 7), transfusion-related acute lung injury (n = 11), and severe allergic transfusion reactions (n = 3). However, only 2 of 36 SAEs were judged as definitely related to the convalescent plasma transfusion by the treating physician. The 7-day mortality rate was 14.9%.CONCLUSIONGiven the deadly nature of COVID-19 and the large population of critically ill patients included in these analyses, the mortality rate does not appear excessive. These early indicators suggest that transfusion of convalescent plasma is safe in hospitalized patients with COVID-19.TRIAL REGISTRATIONClinicalTrials.gov NCT04338360.FUNDINGMayo Clinic, Biomedical Advanced Research and Development Authority (75A50120C00096), National Center for Advancing Translational Sciences (UL1TR002377), National Heart, Lung, and Blood Institute (5R35HL139854 and R01 HL059842), National Institute of Diabetes and Digestive and Kidney Diseases (5T32DK07352), Natural Sciences and Engineering Research Council of Canada (PDF-532926-2019), National Institute of Allergy and Infectious Disease (R21 AI145356, R21 AI152318, and AI152078), Schwab Charitable Fund, United Health Group, National Basketball Association, Millennium Pharmaceuticals, and Octapharma USA Inc.
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http://dx.doi.org/10.1172/JCI140200DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7456238PMC
September 2020

Pulmonary Coccidioidomycosis.

Semin Respir Crit Care Med 2020 02 30;41(1):42-52. Epub 2020 Jan 30.

Division of Infectious Diseases, Mayo Clinic Hospital, Phoenix, Arizona.

Coccidioidomycosis is an infection caused by the geographically restricted dimorphic fungus, . Coccidioidomycosis occurs endemically in the southwestern and western United States, mainly in focused regions of Arizona and California where the incidence is highest, and in Central and South America. Patients with impaired immunity, especially those with impaired cellular immunity, are at higher risk of severe and disseminated disease. In this review, we describe the fungal ecology and mycology, epidemiology, pathophysiology, and normal immune defenses to as well as address current concepts in diagnosis, treatment, and continued care of patients with pulmonary coccidioidomycosis. We also present and answer our most frequently asked questions regarding patients with primary pulmonary coccidioidomycosis.
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http://dx.doi.org/10.1055/s-0039-3400998DOI Listing
February 2020

Coccidioides (spherulin) skin testing in patients with pulmonary coccidioidomycosis in an endemic region†.

Med Mycol 2020 Jul;58(5):626-631

Division of Infectious Diseases, Mayo Clinic Hospital, Phoenix, Arizona.

Coccidioidomycosis is an endemic fungal infection of the desert southwestern United States. Intact cellular immunity is critical to the control of this infection. A recently released reformulated spherulin antigen (Spherusol; Nielsen BioSciences, Inc.) was approved to detect delayed-type hypersensitivity, which implies the presence of cellular immunity, to Coccidioides species. We aimed to summarize our experience with this test in patients with primary pulmonary coccidioidomycosis. We retrospectively reviewed clinical data for all patients with primary pulmonary coccidioidomycosis who had a Coccidioides (spherulin) skin test (CST) placed at our institution between January 1, 2015, and August 31, 2017. During the study period, 172 patients had a CST placed, and 122 met our inclusion criteria for proven or probable pulmonary coccidioidomycosis. Of these 122, 88 (72.1%) had a positive CST result and 34 (27.9%) had a negative result. In the positive CST group, 74 of the 79 treated patients (93.7%) had antifungal treatment stopped, 1 of whom (1.4%) had relapsed infection. In contrast, 27 of the 33 treated patients in the negative CST group (81.8%) had their antifungal treatment stopped, and none had a relapse. Seven patients overall (5.7%), all of whom had a positive CST, experienced mild local adverse reactions to the CST. Although previous controlled studies of CST showed sensitivity and specificity greater than 98%, our real-world experience with the CST showed lower rates of positivity. Negative CST results did not predict relapse with antifungal agent withdrawal.
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http://dx.doi.org/10.1093/mmy/myz099DOI Listing
July 2020

Treatment for Early, Uncomplicated Coccidioidomycosis: What Is Success?

Clin Infect Dis 2020 04;70(9):2008-2012

Division of Infectious Diseases, Department of Internal Medicine, University of California, Davis Medical Center, Sacramento, California, USA.

The care of primary pulmonary coccidioidomycosis remains challenging. Such infections produce a variety of signs, symptoms, and serologic responses that cause morbidity in patients and concern in treating clinicians for the possibility of extrapulmonary dissemination. Illness may be due to ongoing fungal growth that produces acute inflammatory responses, resulting in tissue damage and necrosis, and for this, administering an antifungal drug may be of benefit. In contrast, convalescence may be prolonged by other immunologic reactions to infection, even after fungal replication has been arrested, and in those situations, antifungal therapy is unlikely to yield clinical improvement. In this presentation, we discuss what findings are clinical indicators of fungal growth and what other sequelae are not. Understanding these differences provides a rational management strategy for deciding when to continue, discontinue, or reinstitute antifungal treatments.
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http://dx.doi.org/10.1093/cid/ciz933DOI Listing
April 2020

Pregnancy and Parenting During Cardiology Fellowship.

J Am Heart Assoc 2019 07 9;8(14):e012137. Epub 2019 Jul 9.

1 Department of Internal Medicine Mayo Clinic Jacksonville FL.

Background An increasing number of residents and fellows have children during training. However, little is known about the specific experience of cardiology fellows who become parents during training. Methods and Results A 66-question Internet-based survey about experiences of pregnancy during graduate medical training was administered between May 1 and July 15, 2013, to all trainees (N=1516) in the Mayo School of Graduate Medical Education across 3 academic sites. Questions explored the experiences of new mothers, fathers, and their fellow trainees. There were 644 survey respondents overall (response rate, 42%), and of 73 cardiovascular trainees, 29 (10 women [35%]) completed the survey. Of those surveyed, 59% reported having children. All trainee mothers reported making alterations to their training schedule due to pregnancy and maternity leave. Twenty percent of trainee fathers also reported changing their training because of their partner's pregnancy. Of trainees with children, 41% reported difficulty completing research because of pregnancy and childcare obligations. Nontrainee mothers were significantly more likely to breastfeed beyond 6 months compared with trainee mothers ( P=0.018). A perceived stigma attached to pregnancy was reported by 62% of trainees. Both male and female trainees felt that their programs did not promote pregnancy-related schedule flexibility. Conclusions Our study shows that both men and women entering parenthood during cardiology training often have to change their schedule, research, and career path. Cardiology training programs should focus on curriculum design and supportive parenthood policies to both avoid negative stigma and optimize fellowship training during this time period.
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http://dx.doi.org/10.1161/JAHA.119.012137DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6662139PMC
July 2019

Central Nervous System Infections Due to Coccidioidomycosis.

J Fungi (Basel) 2019 Jun 28;5(3). Epub 2019 Jun 28.

Division of Infectious Diseases, Mayo Clinic in Arizona, Phoenix, AZ 85054, USA.

Coccidioidomycosis is a common infection in the western and southwestern United States as well as parts of Mexico and Central and South America and is due to the soil-dwelling fungi . Central nervous system (CNS) infection is an uncommon manifestation that is nearly always fatal if untreated. The presentation is subtle, commonly with headache and decreased mentation. The diagnosis should be considered in patients with these symptoms in association with a positive serum coccidioidal antibody test. The diagnosis can only be established by analysis of cerebrospinal fluid (CSF), which typically demonstrates a lymphocytic pleocytosis, hypoglycorrhachia, elevated protein, and positive CSF coccidioidal antibody. Cultures are infrequently positive but a proprietary coccidioidal antigen test has reasonable sensitivity. Current therapy usually begins with fluconazole at 800 mg daily but other triazole antifungals also have efficacy and are often used if fluconazole fails. Triazole therapy should be lifelong. Intrathecal amphotericin B, the original treatment, is now reserved for those in whom triazoles have failed. There are several distinct complications of CNS coccidioidal infection, the most common of which is hydrocephalus. This is nearly always communicating and requires mechanical shunting in addition to antifungal therapy. Other complications include cerebral vasculitis, brain abscess, and arachnoiditis. Management of these is difficult and not well established.
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http://dx.doi.org/10.3390/jof5030054DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6787616PMC
June 2019

De novo coccidioidomycosis among solid organ transplant recipients 1 or more years after transplant.

Am J Transplant 2019 09 26;19(9):2517-2524. Epub 2019 Mar 26.

Division of Infectious Diseases, Banner University Medical Center, University of Arizona, Tucson, Arizona.

Solid organ transplant recipients who contract coccidioidomycosis are at risk for complicated, protracted, disseminated, and severe disease. To date, no studies have described outcomes for patients who develop coccidioidomycosis only after the first posttransplant year. This study was a joint project of Mayo Clinic Hospital, Phoenix, Arizona, and the University of Arizona/Banner University Medical Center, Tucson, Arizona. We retrospectively reviewed electronic health records for patients with a history of solid organ transplant between January 1, 1998, and October 11, 2014, who developed coccidioidomycosis after the first transplant year. We identified 91 patients. Of those, 37/91 (40.7%) had pulmonary coccidioidomycosis (29/37 [78.4%] were symptomatic); and 5/91 (5.5%) had extrapulmonary disease (all were symptomatic). One patient (1.1%) died. Coccidioidomycosis was evident in 2/91 (2.2%) patients within 3 months of antirejection treatment. Many of the patients (51/91 [56.0%]) had asymptomatic coccidioidomycosis, 27 (27.9%) of whom were followed up closely but did not receive antifungal medication and had no sequelae. Although solid organ recipients taking low-level immunosuppression after the first posttransplant year appeared to have less symptomatic, disseminated, or fatal coccidioidal infection than historical cohorts, this remains an important infection with morbidity and mortality even after the first posttransplant year.
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http://dx.doi.org/10.1111/ajt.15324DOI Listing
September 2019

Comparison of two FDA-cleared EIA assays for the detection of Coccidioides antibodies against a composite clinical standard.

Med Mycol 2018 Oct 16. Epub 2018 Oct 16.

Division of Infectious Diseases, Department of Medicine, Mayo Clinic in Arizona, Phoenix, Arizona, USA.

Coccidioidomycosis is a disease endemic to the southwestern United States, parts of Mexico, and Central and South America. Diagnosis of the disease is commonly delayed because of the lack of prompt testing and the dearth of reliable diagnostic tests. Culture and nucleic acid testing require a specimen, yet the typical patient presents with a dry cough and no sputum. Serologic methods depend on an effective antibody response by the patient, but antibody production may be unreliable or delayed until several weeks after initial symptom onset. Most published reports of serologic assays compare them to traditional serologic tests such as complement fixation and immunodiffusion. We sought to characterize the performance of two commercially available serologic tests, Meridian Premier and IMMY Omega, against a composite clinical reference standard to determine the sensitivity and specificity of these tests in detecting whether antibody is likely present in clinical specimens. The composite reference standard included symptoms, radiologic findings, and serologic results from complement fixation and immunodiffusion. For the Meridian test, sensitivity and specificity respectively were 69.4% and 95.4% for immunoglobulin G (Ig G) and 57.1% and 70.4% for immunoglobulin M (IgM). For the IMMY assay, sensitivity and specificity respectively were 53.1% and 96.7% for IgG and 34.7% and 85.5% for IgM.
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http://dx.doi.org/10.1093/mmy/myy094DOI Listing
October 2018

Cutaneous effects associated with fluconazole in patients treated for coccidioidomycosis.

Int J Dermatol 2019 Feb 19;58(2):250-253. Epub 2018 Sep 19.

Division of Infectious Diseases, Mayo Clinic Hospital, Phoenix, AZ, USA.

Background: Fluconazole is the most commonly used antifungal treatment for various forms of coccidioidomycosis. Although we had anecdotally observed a high proportion of patients reporting cutaneous adverse effects associated with fluconazole treatment, this observation was not well described in the medical literature, and we were unsure of the additional effect of the arid desert environment of Arizona.

Methods: We performed a one-time, voluntary survey of patients with coccidioidomycosis and compared the responses of patients treated with fluconazole with those of untreated patients.

Results: From January 1, 2015, to August 22, 2017, 62 fluconazole-treated and 35 untreated patients with coccidioidomycosis provided consent and were enrolled in the study; demographics were similar between the two groups. Among the 62 fluconazole-treated patients, daily dosages ranged from 200 mg to 800 mg. However, most (44/62, 71%) took 400 mg daily, the typical dose for the treatment of coccidioidomycosis. The median fluconazole treatment duration at the time of study participation was 6 months. When compared with untreated patients, those taking fluconazole had more moderate to severe dry lips (74.2% [46/62] vs. 23.5% [8/34]; P < 0.001), dry skin (45.8% [27/59] vs. 22.9% [8/35]; P = 0.03), and alopecia (31.1% [19/61] vs. 11.4% [4/35]; P = 0.004).

Conclusions: For the treatment of coccidioidomycosis, patients receiving fluconazole reported significantly more severe cutaneous effects, including dry lips, dry skin, and alopecia, than untreated patients. Our findings identify an association but do not prove causality.
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http://dx.doi.org/10.1111/ijd.14238DOI Listing
February 2019

The Utility of Screening for Coccidioidomycosis in Recipients of Inhibitors of Tumor Necrosis Factor α.

Clin Infect Dis 2019 03;68(6):1024-1030

Division of Infectious Diseases, Mayo Clinic, Scottsdale, Arizona.

Background: Tumor necrosis factor α inhibitors (TNFi) are commonly used to treat immune-mediated disorders, but they are associated with an increased risk of mycobacterial and fungal infections. We compared the outcomes of TNFi recipients screened for asymptomatic coccidioidomycosis with those of unscreened patients to compare the development of symptomatic coccidioidomycosis and to describe its outcomes for patients with abnormal coccidioidal screenings.

Methods: We searched electronic health records from 4 September 2010 through 26 September 2016 for all patients receiving a TNFi for dermatologic, rheumatologic, or gastroenterologic diagnoses, then categorized patients by whether or not they had undergone coccidioidal serologic testing for screening or diagnostic purposes.

Results: A total of 2793 patients had a TNFi prescribed. Of those, 1951 met the inclusion criteria: 1025/1951 (52.5%) never had coccidioidal screening; 925/1951 (47.4%) had serologic screening either before beginning TNFi therapy or annually, or both after beginning a TNFi. Symptomatic coccidioidomycosis developed in 35/1025 (3.4%) unscreened patients. Of those screened, 861/925 (93.1%) had negative serologic tests, of which 11/861 (1.3%) subsequently developed symptomatic coccidioidomycosis; 36/925 (3.9%) had coccidioidomycosis at screening (7, probable infection; 11, possible infection; 18, asymptomatic seropositive result); and 17 had only positive findings for immunoglobulin M antibodies and did not meet the definition for coccidioidomycosis. The unscreened cohort was more likely to have symptomatic coccidioidomycosis than the screened cohort (35/1025 vs 11/861, P < .01).

Conclusions: Screening for asymptomatic coccidioidomycosis within a Coccidioides-endemic area allowed for identifying and managing asymptomatic coccidioidomycosis before patients began TNFi therapy. Less symptomatic infection developed in the screened than the unscreened cohort.
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http://dx.doi.org/10.1093/cid/ciy620DOI Listing
March 2019

Coccidioidomycosis in selected immunosuppressed hosts.

Med Mycol 2019 Feb;57(Supplement_1):S56-S63

Division of Infectious Diseases, Sanford Health, Sioux Falls, South Dakota, USA.

After contracting coccidioidomycosis, persons with impaired cellular immunity are more likely than healthy persons to have severe infection, disseminated infection, and higher mortality rates. In this brief review, we summarize the clinical manifestations, diagnosis, treatment, and prevention of coccidioidomycosis in persons infected with human immunodeficiency virus (HIV), recipients of solid organ or hematopoietic stem cell transplants, and recipients of biologic response modifiers. Among individuals infected with HIV, a diagnosis of acquired immunodeficiency syndrome (AIDS) and a CD4 T-lymphocyte count <250 cells/μl were associated with more severe coccidioidomycosis, whereas less severe disease occurred among those with undetectable HIV-RNA and higher CD4 T-lymphocyte counts, indicating that controlled HIV viremia and improved cellular immune status are important in limiting disease. For transplant recipients whose immunosuppression typically peaks in the first 3 to 6 months and tapers thereafter, the greatest risk of acute coccidioidomycosis occurs 6 to 12 months after transplantation. Relapses of recent coccidioidomycosis may occur during ongoing immunosuppression when patients are not taking suppressive antifungal medication. Recipients of biologic agents, especially those that impair tumor necrosis factor α (TNF-α), may be at increased risk for poorly controlled coccidioidomycosis; however, the best way to prevent and treat such infections has yet to be defined.
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http://dx.doi.org/10.1093/mmy/myy019DOI Listing
February 2019

Single-center experience of antifungal prophylaxis for coccidioidomycosis in heart transplant recipients within an endemic area.

Transpl Infect Dis 2017 Oct 7;19(5). Epub 2017 Aug 7.

Division of Infectious Diseases, Mayo Clinic Hospital, Phoenix, AZ, USA.

In endemic regions, coccidioidomycosis causes substantial morbidity and mortality for patients receiving solid organ transplants. We aimed to demonstrate the effect of antifungal coccidioidal prophylaxis in heart transplant (HT) recipients. We retrospectively reviewed the electronic health records of all patients who received HTs between October 19, 2005, and December 13, 2014. We collected information regarding antifungal regimens and determined whether patients subsequently developed infections. Our 174-person cohort all received antifungal prophylaxis for at least 6 months (mean follow-up, 53.8 months). One proven and one probable coccidioidal infection (each, 0.6%) occurred during the study period. The incidence of coccidioidomycosis was 0.6% at 1 year and 2.3% at 5 years. No cases of proven coccidioidomycosis occurred within 2 years after transplantation. No patients developed disseminated disease, and no sentinel events were attributed to coccidioidomycosis. Both fluconazole and voriconazole were well tolerated. In the absence of intolerance or contraindication, we suggest continuing a universal antifungal prophylactic regimen with fluconazole for at least 6-12 months in HT recipients residing in a coccidioidomycosis-endemic area.
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http://dx.doi.org/10.1111/tid.12744DOI Listing
October 2017

Oxygen Consumption Deficits in Patients With Residual Fatigue After Primary Coccidioidomycosis.

Open Forum Infect Dis 2017 26;4(3):ofx136. Epub 2017 Jun 26.

Valley Fever Center for Excellence, University of Arizona College of Medicine, Tucson.

Patients with coccidioidomycosis often report prolonged and debilitating fatigue after other evidence of infection has resolved. In this study, we quantify fatigue, muscle weakness, and impaired aerobic capacity in 5 such individuals. A closer examination of the cardiorespiratory system may contribute to a better understanding of underlying mechanisms and potential interventions.
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http://dx.doi.org/10.1093/ofid/ofx136DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6300302PMC
June 2017

Divergence in the approach to tumor necrosis factor α-inhibitor recipients with coccidioidomycosis.

Infection 2017 Aug 2;45(4):539-543. Epub 2017 Jun 2.

Division of Infectious Diseases, Mayo Clinic Hospital, 5777 E Mayo Blvd, Phoenix, AZ, 85054, USA.

Background: Tumor necrosis factor α-inhibitors (TNFIs) have been associated with increased risk of certain fungal infections, including coccidioidomycosis. The optimal treatment approach to coccidioidomycosis in TNFI recipients is unknown.

Methods: We constructed an anonymous, voluntary survey for practicing pulmonary and infectious disease physicians in the state of Arizona regarding approach to TNFI patients with coccidioidomycosis.

Results: There is no current consensus on managing these patients.

Conclusions: Further research is necessary to determine the optimal approach to TNFI recipients with coccidioidomycosis.
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http://dx.doi.org/10.1007/s15010-017-1029-9DOI Listing
August 2017

Culture-Proven Thorn-Associated Infections in Arizona: 10-Year Experience at Mayo Clinic.

Open Forum Infect Dis 2017 10;4(1):ofx017. Epub 2017 Feb 10.

Division of Infectious Diseases.

Background: Thorn injuries are common in the desert Southwest; however, the frequency and microbiology of thorn-associated infections have not been systematically described. Most information comes from case reports describing infections from atypical or environmental microorganisms. Our aim was to summarize the spectrum of thorn-associated infections.

Methods: We conducted a retrospective review of electronic health records for patients presenting to our institution from January 1, 2005 to December 31, 2014 for treatment of thorn-associated injuries and then focused on the patients with cultures.

Results: Of 2758 records reviewed, 1327 patients had thorn-associated injuries; however, only 58 (4.4%) had cultures. Of these patients, 37 (64%) had positive findings; 5 had polymicrobial infection. The most commonly identified organisms were (n = 22, 59.0%) and coagulase-negative species (n = 8, 21.6%). Other pathogens included species (n = 3, 8.1%), species (n = 2, 5.4%), Gram-negative bacteria (n = 2, 5.4%), species (n = 2, 5.4%), (n = 1, 2.7%), and species (n = 1, 2.7%). There were no infections caused by , , or spp.

Conclusions: In contrast to most published case reports, we found that typical cutaneous microorganisms, such as species, caused the majority of culture-positive, thorn-related infections.
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http://dx.doi.org/10.1093/ofid/ofx017DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5414025PMC
February 2017

Adjunctive Corticosteroid Therapy in the Treatment of Coccidioidal Meningitis.

Clin Infect Dis 2017 Jul;65(2):338-341

David Geffen School of Medicine, University of California, Los Angeles.

Coccidioidal meningitis (CM) has high morbidity, and adjunctive measures to improve outcomes are needed. Using an established multicenter retrospective cohort study of CM (N = 221), we found that patients receiving adjunctive corticosteroids had a significant reduction in secondary cerebrovascular events (P = .0049). Those with CM-associated cerebrovascular events (8%) may benefit from short-term corticosteroids.
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http://dx.doi.org/10.1093/cid/cix318DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5850006PMC
July 2017

Treatment considerations in pulmonary coccidioidomycosis.

Expert Rev Respir Med 2016 10 22;10(10):1079-91. Epub 2016 Sep 22.

a Division of Infectious Diseases , Mayo Clinic Hospital , Phoenix , AZ , USA.

Introduction: Coccidioidomycosis is an endemic fungal infection caused by the soil-dwelling fungi, Coccidioides species. Coccidioidal infections may be asymptomatic in up to two-thirds of infected persons. Pulmonary coccidioidomycosis is the most common form of symptomatic infection. Fluconazole is the antifungal agent typically used to treat pulmonary coccidioidomycosis. Other azoles and amphotericin B products may be prescribed to treat nuanced aspects of coccidioidomycosis.

Areas Covered: This review discusses current literature regarding medical treatment options, including the various triazoles and amphotericin B products. In addition, we discuss uncomplicated and complicated pulmonary infections and their sequelae and the approach to managing coccidioidomycosis in certain populations of patients, such as pregnant women, transplant recipients, individuals infected with human immunodeficiency virus, and recipients of tumor necrosis factor-α inhibitors. Expert commentary: Symptomatic coccidioidomycosis can present physicians with a number of challenges, including the lack of sensitivity and specificity of diagnostic tests and lack of a standard treatment approach for all patients with the infection. Ongoing and future clinical trials will determine the optimal diagnostic, therapeutic, and prophylactic approaches, particularly for patients with comorbid conditions.
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http://dx.doi.org/10.1080/17476348.2017.1234378DOI Listing
October 2016

Executive Summary: 2016 Infectious Diseases Society of America (IDSA) Clinical Practice Guideline for the Treatment of Coccidioidomycosis.

Clin Infect Dis 2016 09;63(6):717-22

Department of Neurosurgery, Barrow Neurological Institute, Phoenix, Arizona.

It is important to realize that guidelines cannot always account for individual variation among patients. They are not intended to supplant physician judgment with respect to particular patients or special clinical situations. Infectious Diseases Society of America considers adherence to these guidelines to be voluntary, with the ultimate determination regarding their application to be made by the physician in the light of each patient's individual circumstances.Coccidioidomycosis, also known as San Joaquin Valley fever, is a systemic infection endemic to parts of the southwestern United States and elsewhere in the Western Hemisphere. Residence in and recent travel to these areas are critical elements for the accurate recognition of patients who develop this infection. In this practice guideline, we have organized our recommendations to address actionable questions concerning the entire spectrum of clinical syndromes. These can range from initial pulmonary infection, which eventually resolves whether or not antifungal therapy is administered, to a variety of pulmonary and extrapulmonary complications. Additional recommendations address management of coccidioidomycosis occurring for special at-risk populations. Finally, preemptive management strategies are outlined in certain at-risk populations and after unintentional laboratory exposure.
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http://dx.doi.org/10.1093/cid/ciw538DOI Listing
September 2016

Integrative Medicine Preferences Among Coccidioidomycosis (Valley Fever) Patients.

J Altern Complement Med 2017 Feb 24;23(2):135-139. Epub 2016 Aug 24.

4 Division of Women's Health Internal Medicine & Integrative Medicine Program, Mayo Clinic Arizona , Scottsdale, AZ.

Objectives: To understand the extent and modalities of integrative medicine strategies that patients with coccidioidomycosis (valley fever) have incorporated into their treatment regimens.

Design: A direct patient survey was distributed, with 100 unique responses, at a single infectious diseases clinic at an academic medical center in Arizona. Eligible patients, defined as those with confirmed coccidioidomycosis or currently under evaluation, were polled on their personal use of 36 integrative medicine modalities. Patients were also asked to indicate their level of fatigue on a 10-point scale in an attempt to correlate levels of fatigue to use of specific integrative medicine modalities.

Results: Of the patients surveyed, 64% had used at least one integrative medicine modality, and 53% used two or more, along with conventional medical therapy. The top three modalities were nutrition (39%), massage (27%), and breathing exercises (26%). The mean reported fatigue level was 4.7 on a 10-point scale, with a standard deviation of 3.0. There was no statistically significant association between use of a specific modality and reported level of fatigue.

Conclusions: Nearly two thirds of patients (64%) surveyed had used at least one integrative medicine modality throughout the course of their therapy. Clinicians are probably unaware of the extent to which many patients, including this population, have embraced integrative medicine. Awareness of patients' goal and preferences is valuable in shared clinical decision making.
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http://dx.doi.org/10.1089/acm.2016.0139DOI Listing
February 2017
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