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Mirvetuximab Soravtansine in FRα-Positive, Platinum-Resistant Ovarian Cancer
No full textBackground: Mirvetuximab soravtansine-gynx (MIRV), a first-in-class antibody-drug conjugate targeting folate receptor α (FRα), is approved for the treatment of platinum-resistant ovarian cancer in the United States.
Methods: We conducted a phase 3, global, confirmatory, open-label, randomized, controlled trial to compare the efficacy and safety of MIRV with the investigator\u27s choice of chemotherapy in the treatment of platinum-resistant, high-grade serous ovarian cancer. Participants who had previously received one to three lines of therapy and had high FRα tumor expression (≥75% of cells with ≥2+ staining intensity) were randomly assigned in a 1:1 ratio to receive MIRV (6 mg per kilogram of adjusted ideal body weight every 3 weeks) or chemotherapy (paclitaxel, pegylated liposomal doxorubicin, or topotecan). The primary end point was investigator-assessed progression-free survival; key secondary analytic end points included objective response, overall survival, and participant-reported outcomes.
Results: A total of 453 participants underwent randomization; 227 were assigned to the MIRV group and 226 to the chemotherapy group. The median progression-free survival was 5.62 months (95% confidence interval [CI], 4.34 to 5.95) with MIRV and 3.98 months (95% CI, 2.86 to 4.47) with chemotherapy (P\u3c0.001). An objective response occurred in 42.3% of the participants in the MIRV group and in 15.9% of those in the chemotherapy group (odds ratio, 3.81; 95% CI, 2.44 to 5.94; P\u3c0.001). Overall survival was significantly longer with MIRV than with chemotherapy (median, 16.46 months vs. 12.75 months; hazard ratio for death, 0.67; 95% CI, 0.50 to 0.89; P = 0.005). During the treatment period, fewer adverse events of grade 3 or higher occurred with MIRV than with chemotherapy (41.7% vs. 54.1%), as did serious adverse events of any grade (23.9% vs. 32.9%) and events leading to discontinuation (9.2% vs. 15.9%).
Conclusions: Among participants with platinum-resistant, FRα-positive ovarian cancer, treatment with MIRV showed a significant benefit over chemotherapy with respect to progression-free and overall survival and objective response. (Funded by ImmunoGen; MIRASOL ClinicalTrials.gov number, NCT04209855.)
A Novel Algorithm for Improving the Prehospital Diagnostic Accuracy of ST-Segment Elevation Myocardial Infarction
No full textIntroduction: Early detection of ST-segment elevation myocardial infarction (STEMI) on the prehospital electrocardiogram (ECG) improves patient outcomes. Current software algorithms optimize sensitivity but have a high false-positive rate. The authors propose an algorithm to improve the specificity of STEMI diagnosis in the prehospital setting.
Methods: A dataset of prehospital ECGs with verified outcomes was used to validate an algorithm to identify true and false-positive software interpretations of STEMI. Four criteria implicated in prior research to differentiate STEMI true positives were applied: heart rate \u3c130, QRS \u3c100, verification of ST-segment elevation, and absence of artifact. The test characteristics were calculated and regression analysis was used to examine the association between the number of criteria included and test characteristics.
Results: There were 44,611 cases available. Of these, 1,193 were identified as STEMI by the software interpretation. Applying all four criteria had the highest positive likelihood ratio of 353 (95% CI, 201-595) and specificity of 99.96% (95% CI, 99.93-99.98), but the lowest sensitivity (14%; 95% CI, 11-17) and worst negative likelihood ratio (0.86; 95% CI, 0.84-0.89). There was a strong correlation between increased positive likelihood ratio (r2 = 0.90) and specificity (r2 = 0.85) with increasing number of criteria.
Conclusions: Prehospital ECGs with a high probability of true STEMI can be accurately identified using these four criteria: heart rate \u3c130, QRS \u3c100, verification of ST-segment elevation, and absence of artifact. Applying these criteria to prehospital ECGs with software interpretations of STEMI could decrease false-positive field activations, while also reducing the need to rely on transmission for physician over-read. This can have significant clinical and quality implications for Emergency Medical Services (EMS) systems.
Keywords: ECG; ST-segment elevation myocardial infarction; diagnostic accuracy; software interpretation
The Impact of a Web-Based Preintubation Preparation Module on the Knowledge, Confidence, and Behavior of Critical Care Fellows: A Single-Center Pilot Study
No full textObjectives: The objectives of this study were to standardize airway management among critical care fellows and to evaluate whether the completion of a web-based preintubation airway preparation module improves their knowledge and behaviors in the identification and preparation of difficult airways.
Methods: Critical care experts used international guidelines to develop the module, which contained mandatory readings, brief lectures, and a case-based activity. We measured learner satisfaction, improvements in fellows\u27 preintubation preparation knowledge, and safety-oriented behavior. The paired t-test was used to compare knowledge assessment scores and the chi-square test was used to compare the categorical variables in the evaluation of the behavior construct.
Results: All trainees (N = 14) completed the module and were satisfied with its contents and structure. Fellows logged 114 intubations during the study period. The mean score on the knowledge test increased (pre 79% vs post 90%, P = .02) postmodule and there was a significant increase in documentation of airway risk stratification in fellows\u27 procedure notes (65.9% vs 72.9%, P = .049). All respondents were confident that they would be able to apply what they learned in the module into clinical practice and that their patients would likely benefit from their new knowledge.
Conclusion: The implementation of an asynchronous web-based module on airway assessment and intubation preparation was feasible. The module was engaging, enhanced the knowledge of our trainees, and improved procedural documentation.
Keywords: Online learning; asynchronous learning; critical care; intensive care; intubation; medical education
Association Between Nil Per Os Status and Intubated Patients Undergoing Surgery
No full textIntroduction: Patient outcomes heavily rely on nutritional support. However, holding enteric feeds prior to surgical operations in critically ill patients is still a common practice in intensive critical units. Our objective is to describe the relationship between duration of nil per os (NPO) and respiratory outcomes in intubated, critically ill patients requiring operative intervention.
Methods: We conducted a retrospective analysis on intubated, critically ill patients who underwent operative intervention between January 1, 2016, and December 31, 2018, to investigate how the duration of NPO status may affect respiratory outcomes. We compared adverse respiratory events among patients who maintain NPO ≥6 h (NPO group) versus those who were NPO \u3c6 h (non-NPO group) prior to surgery.
Results: Two hundred patients met inclusion criteria: 104 for NPO and 96 for non-NPO. Aspiration event was found in 5.8% of NPO patients and 7.3% in non-NPO patients, P = 0.66. Desaturation event was found in 16.3% for NPO and 14.6% in non-NPO, P = 0.73. Pneumonia was found in 18.3% of NPO patients and 19.8% in non-NPO patients, P = 0.78. Reintubated rates were 13.5% for NPO and 16.7% for non-NPO, P = 0.57. Median (range) hours of NPO for non-NPO was 1.0 h (0-3.0) and 13.0 h (6.0-20.0) for NPO, P \u3c 0.05.
Conclusions: For intubated, critically ill patients requiring operative intervention, there was no difference observed in adverse respiratory events between those kept NPO for 6 h or greater compared to those kept NPO for less than 6 h. Patients were commonly without enteric nutrition for periods of time much greater than the American Society of Anesthesia\u27s recommended 6-h period.
Keywords: Critical care nutrition; Nil per os; Preprocedural fasting
Breaking Barriers: A Single-Center Real-World Experience With Recruitment and Administration of COVID-19 Monoclonal Antibodies and Opportunities for Improvement
No full textWe conducted a retrospective exploratory study evaluating factors associated with selection to receive and infusion with coronavirus disease 2019 monoclonal antibodies. While priority was given to high-risk patients, patients with increased Social Vulnerability Index scores were less likely to present for infusion, raising concern that social factors created barriers to treatment.
Keywords: COVID-19; Social Vulnerability Index (SVI); health disparities; monoclonal antibodies; pandemic
Childhood adversities and risk of posttraumatic stress disorder and major depression following a motor vehicle collision in adulthood
No full textAims: Childhood adversities (CAs) predict heightened risks of posttraumatic stress disorder (PTSD) and major depressive episode (MDE) among people exposed to adult traumatic events. Identifying which CAs put individuals at greatest risk for these adverse posttraumatic neuropsychiatric sequelae (APNS) is important for targeting prevention interventions.
Methods: Data came from n = 999 patients ages 18-75 presenting to 29 U.S. emergency departments after a motor vehicle collision (MVC) and followed for 3 months, the amount of time traditionally used to define chronic PTSD, in the Advancing Understanding of Recovery After Trauma (AURORA) study. Six CA types were self-reported at baseline: physical abuse, sexual abuse, emotional abuse, physical neglect, emotional neglect and bullying. Both dichotomous measures of ever experiencing each CA type and numeric measures of exposure frequency were included in the analysis. Risk ratios (RRs) of these CA measures as well as complex interactions among these measures were examined as predictors of APNS 3 months post-MVC. APNS was defined as meeting self-reported criteria for either PTSD based on the PTSD Checklist for DSM-5 and/or MDE based on the PROMIS Depression Short-Form 8b. We controlled for pre-MVC lifetime histories of PTSD and MDE. We also examined mediating effects through peritraumatic symptoms assessed in the emergency department and PTSD and MDE assessed in 2-week and 8-week follow-up surveys. Analyses were carried out with robust Poisson regression models.
Results: Most participants (90.9%) reported at least rarely having experienced some CA. Ever experiencing each CA other than emotional neglect was univariably associated with 3-month APNS (RRs = 1.31-1.60). Each CA frequency was also univariably associated with 3-month APNS (RRs = 1.65-2.45). In multivariable models, joint associations of CAs with 3-month APNS were additive, with frequency of emotional abuse (RR = 2.03; 95% CI = 1.43-2.87) and bullying (RR = 1.44; 95% CI = 0.99-2.10) being the strongest predictors. Control variable analyses found that these associations were largely explained by pre-MVC histories of PTSD and MDE.
Conclusions: Although individuals who experience frequent emotional abuse and bullying in childhood have a heightened risk of experiencing APNS after an adult MVC, these associations are largely mediated by prior histories of PTSD and MDE.
Keywords: Depression; Trauma; mental health; post traumatic stress disorder
Post hypoxic myoclonus: A tale of two minds
No full textPost hypoxic myoclonus (PHM) is considered a poor prognostic sign and may influence decisions regarding withdrawal of treatment. PHM is generally categorized in literature as either acute or chronic (also commonly referred to as Lance-Adams Syndrome) based on the onset of myoclonus. However, it may be more accurate to differentiate between the various presentations of PHM based on the clinical characteristics and electroencephalogram (EEG) findings for prognostication. Here, we describe a case of a 33-year-old female who presented after a cardiopulmonary arrest. MRI of the brain and cervical spine on admission were unremarkable. Twelve hours later, she developed generalized, stimulus-sensitive myoclonus suggestive of acute PHM. Various medications were trialed, and her symptoms eventually improved on clonazepam. On day 14, she started having resting and intention myoclonus, and dysarthria, consistent with LAS. Several adjustments were again made to her regimen, and she was eventually switched from clonazepam to baclofen which improved her resting myoclonus. This case highlights that PHM can present differently and have a markedly different outcome. It is important to develop a better understanding of the various types of PHM so as to avoid premature withdrawal of care.
Keywords: Lance-Adams syndrome; Myoclonus; Post hypoxic
SAGES/AHPBA guidelines for the use of minimally invasive surgery for the surgical treatment of colorectal liver metastases (CRLM)
No full textBackground: Colorectal liver metastases (CRLM) occur in roughly half of patients with colorectal cancer. Minimally invasive surgery (MIS) has become an increasingly acceptable and utilized technique for resection in these patients, but there is a lack of specific guidelines on the use of MIS hepatectomy in this setting. A multidisciplinary expert panel was convened to develop evidence-based recommendations regarding the decision between MIS and open techniques for the resection of CRLM.
Methods: Systematic review was conducted for two key questions (KQ) regarding the use of MIS versus open surgery for the resection of isolated liver metastases from colon and rectal cancer. Evidence-based recommendations were formulated using the GRADE methodology by subject experts. Additionally, the panel developed recommendations for future research.
Results: The panel addressed two KQs, which pertained to staged or simultaneous resection of resectable colon or rectal metastases. The panel made conditional recommendations for the use of MIS hepatectomy for both staged and simultaneous resection when deemed safe, feasible, and oncologically effective by the surgeon based on the individual patient characteristics. These recommendations were based on low and very low certainty of evidence.
Conclusions: These evidence-based recommendations should provide guidance regarding surgical decision-making in the treatment of CRLM and highlight the importance of individual considerations of each case. Pursuing the identified research needs may help further refine the evidence and improve future versions of guidelines for the use of MIS techniques in the treatment of CRLM.
Keywords: Colorectal cancer; Colorectal liver metastases; Minimally invasive hepatectomy; Open hepatectomy
Facilitators and barriers to collaboration between drug courts and community-based medication for opioid use disorder providers
No full textIntroduction: Access to medications for opioid use disorder (MOUD) is limited for individuals in drug courts - programs that leverage sanctions for mandatory substance use treatment. Drug courts rely on community agencies to provide MOUD. However, relationships with MOUD agencies, which impact access to treatment, are understudied. We examined barriers and facilitators from drug court staffs\u27 perspectives to understand how to enhance collaborations with MOUD providers.
Methods: Drug court staff (n = 21) from seven courts participated in semi-structured interviews about their experience in collaborating with MOUD providers. Interviews were informed by the Consolidated Framework for Implementation Research. Inductive (theory-based) and deductive (ground-up) approaches were used for analyses.
Results: Facilitator and barrier themes centered around the needs and resources of drug court participants, external policies such MOUD access in jails, networking with external agencies, and beliefs about MOUD providers. Drug court staff preferred working with agencies that offered MOUD alongside comprehensive services. Drug courts benefited when jails offered MOUD in-house and facilitated community referrals. Existing relationships with providers and responsive communication eased referrals and served to educate the courts about MOUD. Barriers included logistical limitations (limited hours, few methadone providers) and inadequate communication patterns between providers and drug court staff. A lack of confidence in providers\u27 prescribing practices and concerns around perceived overmedication of participants impacted referrals, interagency collaboration, and further burdened the participants.
Conclusions: Collaboration between drug courts and MOUD providers was driven by patient needs, external policies, communication patterns, and perceptions. Interventions to increase access MOUD for drug court participants will need to incorporate collaboration strategies while considering the unique features of drug courts.
Keywords: Barriers; Drug court; Facilitators; Legal; Medication assisted treatment; Medications for opioid use disorder; Opioid use disorder