Severe Insulin Pump-Related Adverse Events: Potential Root Causes and Impact of the COVID-19 Pandemic.

OBJECTIVE: To explore insulin pump-associated severe adverse events (SAEs) involving intensive care unit (ICU) admissions and deaths and examine the impact of the COVID-19 pandemic on these SAEs. METHODS: Qualitative template analysis of narrative data in reported insulin pump-associated SAEs occurring between May 1, 2019, and January 31, 2021, involving MiniMed 670G, MiniMed 630G, Omnipod, Omnipod DASH, and t:slim X2 insulin pumps. RESULTS: Over the 21-month measurement period, 460 SAEs involving an ICU admission and 288 SAEs involving a death were reported to the Food and Drug Administration. Problems with the pump or pod reservoir/cartridge were among the most frequently cited potential root causes in SAEs involving ICU admissions and deaths overall. However, problems with the infusion set or site and the pump battery or power emerged in the top three potential root causes of SAEs involving an ICU admission, whereas the patient sleeping at the time of the event and the tasks of changing the pod/infusion set, including reservoir/cartridge and programming the pump emerged in the top three for SAEs involving a death. The median monthly number of reported SAEs involving ICU admissions and deaths decreased during the pandemic, but their potential root causes were unchanged. CONCLUSIONS: Although insulin pumps are generally safe, SAEs related to their components and external factors can and do occur. By learning from the potential root causes of insulin pump-associated SAEs, providers and patients can implement corrective actions to prevent future events, thereby reducing harm.

"And Does That Necessarily Mean Absolutely Alzheimer's?" An Analysis of Questions Raised Following Amyloid PET Results Disclosure.

INTRODUCTION: Amyloid PET scans provide individuals with mild cognitive impairment (MCI) information about their risk of progressing to Alzheimer's dementia (AD). Given the wide-ranging implications of this information, best practice guidelines are needed to support researchers and clinicians disclosing these high-stakes test results. To inform the development of such guidelines, this analysis aims to describe questions and concerns raised during the disclosure of amyloid PET results in the context of MCI. METHODS: Qualitative description was performed to analyze (n = 34) transcripts of audio-recorded amyloid PET results disclosure sessions involving MCI care dyads. The analysis focused on characterizing the frequency and nature of questions raised during an open question-and-answer (Q&A) period following the return of scan results using a standardized protocol. RESULTS: Nearly all (n = 32/34) dyads posed questions during Q&A. Questions fell within six main categories with the most common being requests for clarification regarding AD/MCI, and next steps given the result. Questions were interspersed with comments reflecting the need for emotional support. Independently administered assessments of comprehension of results showed that, following the disclosure and Q&A, 31/32 participants with MCI and 31/31 care partners scored ≥4 on a 5-point scale. The number of questions asked by care partners during Q&A positively correlated with their level of comprehension (n = 31, Spearman's r = 0.370, p = 0.040). DISCUSSION: This analysis highlights the value of providing opportunities for patients and their family members to ask questions upon learning patients' brain amyloid status. Disclosing clinicians should be prepared to provide clarification, resources, and support to patients and families during the return of amyloid PET results.

Patient-level factors associated with the self-report of trouble sleeping to healthcare providers in adults at high risk for obstructive sleep apnea.

INTRODUCTION: In adults at risk for obstructive sleep apnea, it is unclear what patient-level factors and symptoms may influence communication with healthcare providers regarding sleep difficulties. This analysis examined associations between sociodemographic characteristics, comorbidities, and obstructive sleep apnea-related symptoms and whether adults at high risk for obstructive sleep apnea reported trouble sleeping to an healthcare provider. METHODS: The sample included participants from the 2015-2018 National Health and Nutrition Examination Survey determined by a modified STOP-Bang to be at high risk for obstructive sleep apnea (n = 2009). Participants were asked if they had ever reported trouble sleeping to an healthcare provider. Self-reported comorbidities and obstructive sleep apnea-related symptoms (ie, snoring, snorting, gasping, or breathing cessation during sleep, daytime sleepiness, fatigue, insomnia, and nocturia) were assessed. RESULTS: Half of the sample (50.8%) never reported trouble sleeping to an healthcare provider. Factors associated with an increased likelihood of reporting trouble sleeping included female sex, former smoker, and prediabetes or diabetes, obstructive lung disease, daytime sleepiness, insomnia, nocturia, and symptoms of snorting, gasping, and/or breathing cessation during sleep. Factors associated with a decreased likelihood of reporting trouble sleeping included Mexican American background or Asian race and having less than a high school education. CONCLUSION: Differences in sex, race, education, comorbidities, and obstructive sleep apnea-related symptoms exist between adults at high risk for obstructive sleep apnea who have and have not reported trouble sleeping to an healthcare provider. It is important for healthcare providers to ask all adults about sleep problems, recognizing that men, minorities, and persons with lower educational attainment may be less likely to report trouble sleeping.

Perioperative management of obstructive sleep apnea in lower extremity orthopedic procedures: A review of evidence to inform the development of a clinical pathway.

Obstructive sleep apnea (OSA) is unrecognized in as high as 80% of patients before surgery. When untreated, OSA increases a surgical patient's propensity for airway collapse and sleep deprivation lending to a higher risk for emergent re-intubation, prolonged recovery time, escalation of care, hospital readmission, and longer length of stay. We have reviewed the evidence regarding diagnostic performance of OSA screening methods and the impact of perioperative management strategies on postoperative complications among patients with diagnosed or suspected OSA who are undergoing orthopedic surgery. We then integrated the data and recommendations from professional society guidelines to develop an evidence-based clinical care pathway to optimize the perioperative management of this surgical population. Successful management of patients with diagnosed or suspected OSA encompass five facets of care: screening, education, airway management, medications, and monitoring. This narrative review revealed two gaps in the evidence to inform management of patients undergoing orthopedic surgery 1) during the perioperative setting to include evidence-based interventions that reduce postoperative complications and 2) after discharge to an unmonitored environment. The clinical care pathway as well as perspectives for future research are discussed.

Ethical Considerations in Communicating Alzheimer's Disease Neuroimaging Biomarker Test Results to Symptomatic Individuals.

This article examines ethical issues associated with the return of AD neuroimaging results to cognitively symptomatic individuals. Following a review of research on patient and study partner reactions to learning the results of biomarker testing for AD, we examine ethical issues that will be of increasing significance as the field transitions to an era wherein disease-modifying treatments for AD become available. We first review the ethical justification for returning AD biomarker results to individuals who desire them. We then address a more novel question: whether, and to what extent, clinicians or clinical researchers should influence the decisions of individuals who are potentially reluctant to learn their AD imaging results. We argue that in many cases, it is ethically correct to explore, and sometimes alter, factors that may be inhibiting one's desire to know these test results. Our argument is grounded in the premise that having more complete information about changes that may be happening in one's brain will generally yield more informed participation in decisions about one's own care, thereby promoting autonomy. Finally, on the assumption that we have established that it is frequently ethically correct to try to communicate testing information, we examine considerations regarding (not whether but) how this is best accomplished, discussing the concept of responsible transparency. We suggest that both (1) explorations of why one may or may not want to learn results of AD biomarker imaging and (2) the responsible return of such test results is best accomplished using a transactional model of communication.