Coronavirus disease 2019 pandemic: staged management of surgical services for gynecology and obstetrics.

The coronavirus disease 2019 pandemic warrants an unprecedented global healthcare response requiring maintenance of existing hospital-based services while simultaneously preparing for high-acuity care for infected and sick individuals. Hospitals must protect patients and the diverse healthcare workforce by conserving personal protective equipment and redeployment of facility resources. While each hospital or health system must evaluate their own capabilities and surge capacity, we present principles of management of surgical services during a health emergency and provide specific guidance to help with decision making. We review the limited evidence from past hospital and community responses to various health emergencies and focus on systematic methods for adjusting surgical services to create capacity, addressing the specific risks of coronavirus disease 2019. Successful strategies for tiered reduction of surgical cases involve multidisciplinary engagement of the entire healthcare system and use of a structured risk-assessment categorization scheme that can be applied across the institution. Our institution developed and operationalized this approach over 3 working days, indicating that immediate implementation is feasible in response to an unforeseen healthcare emergency.

Challenges and lessons learned from clinical pharmacogenetic implementation of multiple gene-drug pairs across ambulatory care settings.

PURPOSE: Incorporating a patient's genotype into the clinical decision-making process is one approach to precision medicine. The University of Florida (UF) Health Precision Medicine Program is a pharmacist-led multidisciplinary effort that has led the clinical implementation of six gene-drug(s) pairs to date. This study focuses on the challenges encountered and lessons learned with implementing pharmacogenetic testing for three of these: CYP2D6-opioids, CYP2D6/CYP2C19-selective serotonin reuptake inhibitors, and CYP2C19-proton pump inhibitors within six pragmatic clinical trials at UF Health and partners. METHODS: We compared common measures collected within each of the pharmacogenetic implementations as well as solicited feedback from stakeholders to identify challenges, successes, and lessons learned. RESULTS: We identified several challenges related to trial design and implementation, and learned valuable lessons. Most notably, case discussions are effective for prescriber education, prescribers need clear concise guidance on genotype-based actions, having genotype results available at the time of the patient-prescriber encounter helps optimize the ability to act on them, children prefer noninvasive sample collection, and study participants are willing to answer patient-reported outcomes questionnaires if they are not overly burdensome, among others. CONCLUSION: The lessons learned from implementing three gene-drug pairs in ambulatory care settings will help shape future pharmacogenetic clinical trials and clinical implementations.

CYP2D6-guided opioid therapy improves pain control in CYP2D6 intermediate and poor metabolizers: a pragmatic clinical trial.

PURPOSE: CYP2D6 bioactivates codeine and tramadol, with intermediate and poor metabolizers (IMs and PMs) expected to have impaired analgesia. This pragmatic proof-of-concept trial tested the effects of CYP2D6-guided opioid prescribing on pain control. METHODS: Participants with chronic pain (94% on an opioid) from seven clinics were enrolled into CYP2D6-guided (n = 235) or usual care (n = 135) arms using a cluster design. CYP2D6 phenotypes were assigned based on genotype and CYP2D6 inhibitor use, with recommendations for opioid prescribing made in the CYP2D6-guided arm. Pain was assessed at baseline and 3 months using PROMIS® measures. RESULTS: On stepwise multiple linear regression, the primary outcome of composite pain intensity (composite of current pain and worst and average pain in the past week) among IM/PMs initially prescribed tramadol/codeine (n = 45) had greater improvement in the CYP2D6-guided versus usual care arm (-1.01 ± 1.59 vs. -0.40 ± 1.20; adj P = 0.016); 24% of CYP2D6-guided versus 0% of usual care participants reported ≥30% (clinically meaningful) reduction in the composite outcome. In contrast, among normal metabolizers prescribed tramadol or codeine at baseline, there was no difference in the change in composite pain intensity at 3 months between CYP2D6-guided (-0.61 ± 1.39) and usual care (-0.54 ± 1.69) groups (adj P = 0.540). CONCLUSION: These data support the potential benefits of CYP2D6-guided pain management.

Patient satisfaction with extended-interval warfarin monitoring.

Extended-interval monitoring of warfarin has been proposed to reduce follow-up burden and improve patient satisfaction. We aimed to make an initial assessment of anticoagulation satisfaction before and after an extended-interval warfarin monitoring intervention. We conducted a translational prospective single-arm pilot study of extended-interval warfarin monitoring in five pharmacist-managed anticoagulation clinics. Patients meeting CHEST guideline criteria for extended-interval warfarin monitoring began progressive extended-interval follow-up (6, 8, and 12 weeks thereafter). The Duke Anticoagulation Satisfaction Scale (DASS) was administered at baseline and at end-of-study or study removal (in patients no longer appropriate for extended interval follow-up). Forty-six patients had evaluable pre- and post-intervention DASS survey data. Mean age of patients was 66.5 years, 74 % were non-Hispanic whites, and 48 % were men. Patients completed a mean ± SD of 34 ± 22 weeks of follow-up. Mean ± SD total DASS score at baseline was 45.2 ± 14.2 versus 49.1 ± 14.9 at end-of-study (mean change, +3.9 [95 % CI -0.6-8.4; p = 0.09]), indicating no benefit-and trending toward decrement-to anticoagulation satisfaction. Change in anticoagulation satisfaction varied substantially following extended-interval monitoring, with no evidence of improved satisfaction. Plausible reasons for patients not preferring extended-interval monitoring include increased anxiety and disengagement from self-management activities, both potentially related to less frequent feedback and reassurance during extended interval-monitoring. Additional research is needed to identify who is likely to benefit most from extended-interval monitoring. Anticoagulation satisfaction should be considered with clinical factors and shared-decision making when implementing extended-interval warfarin monitoring.

Arriving at correct conclusions: the importance of association, causality, and clinical significance.

Declaring that a causal and not solely a correlative relation exists between a risk factor and a disease creates significant implications for patients and physicians. No matter the forum, when investigators or clinicians make such a claim, it is essential to explain how this determination was made so that appropriate recommendations are made in all areas of our professional practice. When we review the medical literature it is similarly crucial to understand this distinction between causality and association. The Bradford Hill criteria of strength of association, consistency, temporality, biological gradient, biological plausibility, coherence, experimental evidence, and analogy can be used to help establish causality. It is also important to understand the distinction between clinical and statistical significance to complete our appraisal of the implications of a clinical study. Statistically significant results, although not the result of chance, may be clinically insignificant. Statistically insignificant results, conversely, may not exclude the possibility of a clinically important relation. This article reviews the concepts of causality and association and clinical versus statistical significance and provides examples from the literature.

Transforming the Culture of Peer Review: Implementation Across Three Departments in an Academic Health Center.

OBJECTIVES: Although many health care institutions believe that clinical peer review is vital for identifying and improving quality of care, peer review is perceived by many clinicians as variable and inherently punitive. Successful peer review requires institutional leadership and adoption of a just culture approach to investigating and determining accountability for medical errors that result in harm. METHODS: We describe how an academic medical center implemented and adapted its clinical peer review processes to be consistent with just culture theory and provide a roadmap that other institutions may follow. Specific examples of peer review are highlighted to show how the process improved patient safety in the departments of emergency medicine, internal medicine, and pediatrics. RESULTS: The most significant process improvement was shifting from a tradition of assigning letter grades of "A," "B," or "C" to determine whether preventable adverse events were caused by "human error," "at-risk behavior," or "reckless behavior." This categorization of human behaviors enabled patient safety officers within 3 departments to develop specific interventions to protect patients and enlist physician support for improving clinical systems. CONCLUSIONS: Each department's success was due to recognition of different patient and provider cultures that offer unique challenges. The transformation of peer review was a crucial first step to shift perceptions of peer review from a punitive to a constructive process intended to improve patient safety. Our experience with reengineering clinical peer review shows the importance of focusing on just culture as a key method to prevent patient harm.

Implementing Delirium Prevention in the Era of COVID-19.

Patients admitted with COVID-19 can develop delirium due to predisposing factors, isolation, and the illness itself. Standard delirium prevention methods focus on interaction and stimulation. It can be challenging to deliver these methods of care in COVID settings where it is necessary to increase patient isolation. This paper presents a typical clinical vignette of representative patients in a tertiary care hospital and how a medical team modified an evidence-based delirium prevention model to deliver high-quality care to COVID-19 patients. The implemented model focuses on four areas of delirium-prevention: Mobility, Sleep, Cognitive Stimulation, and Nutrition. Future studies will be needed to track quantitative outcome measures.

Design and Early Implementation Successes and Challenges of a Pharmacogenetics Consult Clinic.

Pharmacogenetic testing (PGT) is increasingly being used as a tool to guide clinical decisions. This article describes the development of an outpatient, pharmacist-led, pharmacogenetics consult clinic within internal medicine, its workflow, and early results, along with successes and challenges. A pharmacogenetics-trained pharmacist encouraged primary care physicians (PCPs) to refer patients who were experiencing side effects/ineffectiveness from certain antidepressants, opioids, and/or proton pump inhibitors. In clinic, the pharmacist confirmed the need for and ordered CYP2C19 and/or CYP2D6 testing, provided evidence-based pharmacogenetic recommendations to PCPs, and educated PCPs and patients on the results. Operational and clinical metrics were analyzed. In two years, 91 referred patients were seen in clinic (mean age 57, 67% women, 91% European-American). Of patients who received PGT, 77% had at least one CYP2C19 and/or CYP2D6 phenotype that would make conventional prescribing unfavorable. Recommendations suggested that physicians change a medication/dose for 59% of patients; excluding two patients lost to follow-up, 87% of recommendations were accepted. Challenges included PGT reimbursement and referral maintenance. High frequency of actionable results suggests physician education on who to refer was successful and illustrates the potential to reduce trial-and-error prescribing. High recommendation acceptance rate demonstrates the pharmacist's effectiveness in providing genotype-guided recommendations, emphasizing a successful pharmacist-physician collaboration.

Teaching Students How to Improve Safety and Quality in Two Children's Hospitals: Building a Pediatric Clerkship Patient Safety and Quality Experience.

This report describes a novel method to enhance medical student understanding of systems-based practice and patient safety through experiential learning, assessing the perceived value of student-identified patient safety and systems vulnerabilities, and their proposed interventions at academic children's hospitals.

Complementary and alternative medicine use by primary care patients with chronic pain.

OBJECTIVES: To describe the characteristics and attitudes toward complementary and alternative medicine (CAM) use among primary care patients with chronic pain disorders and to determine if CAM use is associated with better pain control. DESIGN: Cross-sectional survey. SUBJECTS: Four hundred sixty-three patients suffering from chronic, nonmalignant pain receiving primary care at 12 U.S. academic medical centers. OUTCOME MEASURE: Self-reported current CAM usage by patients with chronic pain disorders. RESULTS: The survey had an 81% response rate. Fifty-two percent reported current use of CAM for relief of chronic pain. Of the patients that used CAM, 54% agreed that nontraditional remedies helped their pain and 14% indicated that their individual alternative remedy entirely relieved their pain. Vitamin and mineral supplements were the most frequently used CAM modalities. There was no association between reported use of CAM and pain severity, functional status, or perceived self-efficacy. Patients who reported having at least a high school education (odds ratio [OR] 1.1, 95% confidence interval [CI] 1.02-1.19, P = 0.016) and high levels of satisfaction with their health care (OR 1.47, 95% CI 1.13-1.91, P = 0.004) were significantly more likely to report using CAM. CONCLUSIONS: Complementary and alternative therapies were popular among patients with chronic pain disorders surveyed in academic primary care settings. When asked to choose between traditional therapies or CAM, most patients still preferred traditional therapies for pain relief. We found no association between reported CAM usage and pain severity, functional status, or self-efficacy.

A 3-minute test of cardiorespiratory fitness for use in primary care clinics.

BACKGROUND: Cardiorespiratory fitness (CRF) is the only major risk factor that is not routinely assessed in the clinical setting, for preventive medicine. A valid and practical CRF test is needed for use in the clinics. The objective of this study is to demonstrate the validity of a 3-minute squat test to assess CRF in primary care. METHODS: A cross-sectional study in which the participants performed both the Ruffier squat test and the Balke maximal treadmill test. The study was conducted in a clinical setting from September 2016 to March 2017. We recruited a convenient sample of 40 adults between 18 and 64 years from the general U.S. population. Participants completed 30 squats in 45 seconds, paced by a metronome. Heart rate was measured at rest (P1), immediately after the test (P2), one minute after the test (P3). [Formula: see text] was measured using the Balke maximal treadmill fitness test. RESULTS: Of the 40 participants, there were 18 men and 22 women. Mean age was 31.2 years (SD = 9.9). We found that the best [Formula: see text] predictors were HR features P1/height and (P2-P3)/age3. Our best-performing model using these two features predicted individuals' CRF levels with an adjusted R2 of 0.637, sensitivity of 0.79, and specificity of 0.56. CONCLUSIONS: The study provided strong evidence for the validity of the squat test in the clinical setting. Further, the equation of our model along with [Formula: see text] normative tables provides an efficient and easy way to assess CRF in a primary care setting.

Sodium chloride pica causing recurrent nephrolithiasis in a patient with iron deficiency anemia: a case report.

BACKGROUND: Iron deficiency anemia is a common finding in women of child-bearing age. Pica, or the ingestion of non-food or non-nutritive items, is a well-known manifestation of iron deficiency. A high sodium diet increases risk for nephrolithiasis. We describe the case of a 31-year-old woman with recurrent calcium nephrolithiasis and anemia who ate ice chips as well as spoons of salt daily. Treatment of pica may prove effective in preventing recurrent nephrolithiasis. CASE PRESENTATION: A 31-year-old white woman with a past medical history of menorrhagia, anemia, and recurrent calcium nephrolithiasis presented for preoperative evaluation prior to ureterolithotomy. She described a daily pattern of eating continually from a cup of ice chips accompanied by multiple spoons of salt directly out of a salt shaker. These cravings had been present for many years, were bothersome to her, and interfered with her daily life. Laboratory findings revealed hemoglobin of 10.9 g/dL with ferritin of 3 ng/mL. History, physical, and laboratory data were consistent with pica secondary to iron deficiency anemia. She was prescribed orally administered ferrous sulfate 325 mg three times a day with meals. She continues to struggle with the symptoms of pica and orally administered supplementation. CONCLUSIONS: It is important that clinicians consider the possible diagnosis of sodium chloride pica in patients with iron deficiency anemia and recurrent nephrolithiasis. Treatment of anemia and resolution of pica may prove effective in preventing future nephrolithiasis. Specific questioning about pica symptoms in patients with iron deficiency anemia and recurrent nephrolithiasis may be helpful diagnostically and therapeutically.

Feasibility of Extended-interval Follow-up for Patients Receiving Warfarin.

AIMS: The 2012 American College of Chest Physician Evidence-Based Management of Anticoagulant Therapy guidelines suggest an international normalized ratio (INR) testing interval of up to 12 weeks, rather than every 4 weeks, for patients with consistently stable INRs while taking vitamin K antagonists. We aimed to examine the feasibility of extended-interval follow-up in a real-world setting. METHODS: Patients receiving stable warfarin therapy for ≥ 12 weeks at baseline began extended-interval follow-up with visits occurring at 6 weeks, 14 weeks, and every 12 weeks thereafter to a maximum of 68 weeks or until they were no longer suitable for extended-interval follow-up. A single INR excursion >0.3 from goal was permitted if a reversible precipitating factor was identified and the INR was expected to return to goal without dose adjustment. The primary outcome was the proportion of patients completing all study follow-up visits. RESULTS: Of 48 patients enrolled, 47 had evaluable data. The most common indication for anticoagulation was atrial fibrillation/flutter (53.2%). At baseline, mean prior warfarin treatment duration was 6.7 ± 6 years and median number of weeks on a stable regimen was 24 weeks (IQR, 19-37.5). Eleven patients (23%) completed all study follow-up visits, whereas 17 (36%) did not maintain a stable INR past the 14-week follow-up. CONCLUSION: A large proportion of patients with previously stable (≥ 3 months) INRs were not able to maintain stable INRs during extended-interval follow-up. More research is needed to identify patient characteristics predictive of success with extended-interval follow-up prior to broad implementation.

Angiotensin-converting enzyme inhibitor-induced isolated visceral angioedema in a liver transplant recipient.

Isolated visceral angioedema is an extremely rare complication of angiotensin-converting enzyme inhibitors (ACEIs). We report the first known case of ACEI-associated visceral angioedema occurring in a liver transplant recipient who presented with acute-onset abdominal pain, nausea, vomiting, diarrhea, radiologic findings of small bowel edema, and ascites. Heightened awareness of the phenomenon of isolated ACEI-associated visceral angioedema is necessary given the increasing use of these medications for treating hypertension related to calcineurin inhibitors and the need to avoid unnecessary surgical or diagnostic interventions in solid-organ transplant recipients.

Nature and causes of clinically significant medication errors in a tertiary care hospital.

PURPOSE: Medication errors identified through solicited error reports in general medicine and specialty units of a major tertiary care teaching hospital were studied to identify prevalent patterns and causes. METHODS: Medication error reports by a multidisciplinary team of eight clinicians at adult medical and surgical, hematology and oncology, bone marrow transplantation, and medical and cardiac intensive care units were collected prospectively over a three-month period. The reports were validated in terms of clinical significance, causality, and true presence of an error by two independent reviewers. Cluster analysis of valid reports (reports accepted by both reviewers) was used to identify prominent error patterns. RESULTS: Of 321 medication error reports, 240 were included in the analysis. Of these, 95 represented manifested errors and the rest near misses (not manifested [94] or averted [51]). Most manifested errors involved uncontrolled infections associated with prescribed underdoses of antiinfectives (23%), renal failure associated with prescribed overdoses of antiinfectives (4%), central-nervous-system drug intoxication following prescribed overdoses (4%), or uncontrolled pain associated with prescribed underdoses (4%). Most errors were initiated during prescribing (72%) and were associated with deficits in pharmacotherapy knowledge (39%) or with failure to consider critical patient information (18%). Errors initiated during dispensing and administration were mostly associated with performance deficits (e.g., accidental slips and lapses). CONCLUSION: A limited number of prevalent medication-error patterns described more than half of all reported errors in a hospital and suggested excellent areas for quality improvement. Error causes varied with the node of the medication-use process where they arose and suggested the need for tailored interventions to improve clinicians' performance.

Perioperative medication errors in otolaryngology.

OBJECTIVES/HYPOTHESIS: Medication errors are a common cause of poor clinical outcomes. Information on perioperative medication errors is scarce. This study was aimed at identifying the nature, cause, and potential remedies for medication errors in otolaryngologic surgery. STUDY DESIGN: Prospective and descriptive. METHODS: Clinicians were incentivized for reporting possible medication errors that occurred from the preoperative through the first postoperative clinic visit over a 2-month period. Each report was investigated by an expert panel to determine validity, preventability, contributing factors, and potential preventative measures. A random sample of procedures and clinic visits were monitored for compliance with safe medication practices and information flow. RESULTS: From 589 surgeries, 20 medication errors were reported (two preoperative, four operative, five during hospital admission, two in transition between services, four during discharge, and three postoperative). Errors included wrong dose (seven), omitted dose (six), wrong drug (five), wrong site (two), and unnecessary drug (one). Causes included failure to consider weight-based dosing, use accurate drug references, calculate the total medication supply needed, verify the administration site, consider pertinent patient information (e.g., allergies), reconcile medications upon transfers, and document medication histories. Use of preprinted order forms was flawed, and discharge instructions were insufficient to guide patients postoperatively. CONCLUSIONS: Failure to adhere to safe medication-use practices occurred throughout perioperative care. Improvement in medication documentation, following established safe practices, integration of patient information in prescribing decisions, and use of clinical decision support systems appear necessary to prevent perioperative medication errors in otolaryngology.

Patient safety education at U.S. and Canadian medical schools: results from the 2006 Clerkship Directors in Internal Medicine survey.

PURPOSE: To describe current patient safety curricula at U.S. and Canadian medical schools and identify factors associated with adoption of these programs. METHOD: A survey was mailed to institutional members of the Clerkship Directors in Internal Medicine at U.S. and Canadian academic medical schools in 2006. Respondents self-reported implementation of patient safety curricula and associated methods of instruction at the institution level. RESULTS: The survey had a 76% response rate (83/110). Only 25% of institutional members reported that their schools had explicit patient safety curricula. All respondents that reported having curricula use lectures and small-group instruction, and these were more likely to occur in preclinical settings. Topics and methods of instruction included reporting adverse incidents and analysis of medical errors; improvement of physician order writing to prevent medication errors; core measures; national patient safety goals; and standardization of medical care through the use of clinical guidelines and order set templates. Although only 25% of respondents reported having explicit curricula, 72% agreed that patient safety instruction should occur during medical school. CONCLUSIONS: Despite calls from regulatory, medical, and educational organizations to increase patient safety training of medical students, internal medicine clerkship directors report that few schools in the United States and Canada have implemented specific patient safety curricula. Most existing patient safety curricula use lecture and small-group discussion as preferred methods of instruction.

Diabetic myonecrosis in an orthotopic heart transplant recipient.

Diabetic myonecrosis or muscle infarction (DMI) is a rare cause of lower extremity pain that usually occurs in patients with poorly controlled diabetes. Although most patients recover with opiate analgesics and anti-inflammatory medications, this type of myonecrosis is associated with the presence of serious vascular disease. Consideration of this diagnosis and use of soft-tissue imaging are especially important in diabetic organ transplant recipients to prevent erroneous treatment for presumed infection. We describe what we believe is the first reported case of diabetic myonecrosis occurring in a patient with iatrogenically induced diabetes after orthotopic heart transplantation.