Independent Physician Reviewers Research Articles

37 Adverse events associated with paediatric emergency medicine virtual clinic visits

Abstract Background Emergency medical care inherently carries a potential for adverse events. With the increase in virtual medical care due to its ease of access and ability to limit the spread of infection, there is a need to evaluate the safety of paediatric emergency medicine virtual clinics. Objectives To elucidate the frequency of adverse events occurring within 7 days of accessing medical care provided by a Paediatric Emergency Medicine Virtual Clinic. We then seek to characterize the severity, nature, and preventability of the adverse events and to provide a knowledge base for future work related to patient safety in the virtual emergency care domain. Design/Methods This study was a prospective cohort study where the primary outcome was the proportion of patients who experienced an adverse event within 7 days of accessing care through a virtual emergency clinic. Data was collected through telephone interviews and chart analysis with the use of a validated adverse events trigger tool to determine which charts required independent physician review. The final data was categorized using descriptive statistics, and logistic regression analysis was conducted to examine potential predictors of adverse events. Results Of 593 eligible families, 232 (39%) consented to participate and completed the interview process. Of these families, 89 were flagged for further review, and subsequent analysis concluded that 5 (2.2%) had experienced an adverse event. Of the adverse events, 4 (80%) were considered preventable and the most common type of adverse event was sub-optimal follow up (60%). The median patient age was 3.0 years (IQR 1.0-5.0). There were no clinically significant differences between the patients who experienced an adverse event and those that did not across the parameters studied (age, sex, gender, medical complexity, length of symptoms, language of fluency, and self-identification of visible minority status). Conclusion 2.2% of patients, approximately 1 in 45, experienced adverse events related to the care they received at the virtual clinic. The majority of these adverse events were preventable. That said, the rates of events were within the published norm, suggesting the virtual clinic provides a viable option in paediatric emergency medicine.

Should I See You Again Soon? Multispecialty Assessment of Impact and Burden of Preoperative History and Physical Update Visits.

Federal regulations require a history and physical (H&P) update performed 30 days or less before a planned procedure. We evaluated the use and burdens of H&P update visits by determining impact on operative management, suitability for telehealth, and visit time and travel burden. We identified H&P update visits performed in our health system during 2019 for 8 surgical specialties. As available, up to 50 visits per specialty were randomly selected. Primary outcomes were interval changes in history, examination, or operative plan between the initial and updated H&P notes, and visit suitability for telehealth, as determined by 2 independent physician reviewers. Clinic time was captured, and round-trip driving time and distance between patients' home and clinic ZIP codes were estimated. We identified 8,683 visits and 362 were randomly selected for review. Documented changes were most commonly identified in histories (60.8%), but rarely in physical examinations (11.9%) and operative plans (11.6%). Of 362 visits, 359 (99.2%) visits were considered suitable for telehealth. Median clinic time was 52 minutes (interquartile range 33.8 to 78), driving time was 55.6 minutes (interquartile range 35.5 to 85.5), and driving distance was 20.2 miles (interquartile range 8.5 to 38.4). At the health system level, patients spent an estimated aggregate 7,000 hours (including 4,046 hours of waiting room and travel time) and drove 142,273 miles to attend in-person H&P update visits in 2019. Given their minimal impact on operative management, regulatory requirements for in-person H&P updates should be reconsidered. Flexibility in update timing and modality might help defray the substantial burdens these visits impose on patients.

The prognostic value of HEART score in patients with known heart failure evaluated at the emergency department for acute chest pain

Abstract Funding Acknowledgements Type of funding sources: Public grant(s) – National budget only. Main funding source(s): National Heart Lung and Blood Institute (United States). Background Chest pain is a common and concerning symptom in emergency care, often necessities further risk stratification for adverse cardiovascular events on short-term follow up. Patients with known heart failure (HF) constitutes a unique sub-population that would greatly benefit from short-term risk stratification to guide appropriate clinical interventions and optimize resource allocation. HEART (History, ECG, Age, Risk factors, Troponin) is a well-validated risk score that has been shown to outperform other clinical risk scores in patients with chest pain. It remains unknown if HEART score can be safely used in patients with known HF presenting to the emergency department with chest pain. Purpose We sought to evaluate the prognostic value of HEART score in patients with known HF compared to their counterparts. Method This was a prospective observational cohort study of consecutive adult patients evaluated at the emergency department for non-traumatic chest pain. HEART score was computed from charts by independent physician reviewers. The primary study outcome was major adverse cardiac events (MACE) defined as acute coronary syndrome, invasive revascularization, reinfarction, death, cardiac arrest, ventricular tachyarrhythmia, or acute exacerbation within 30 days of indexed admission. Outcomes were adjudicated by two independent reviewers (Kappa = 0.908). Classification performance between groups was compared using area under receiver operator characteristic curve (AUROC), sensitivity, and negative predictive value (NPV). Results Our cohort included 4,132 patients (age 59±16, 47% female, 33% Black). Overall, 921 patients (22.3%) experienced 30-day MACE. The classification performance of HEART score in those without HF (n = 3,329, 81%) was AUROC of 0.831 (95% CI 0.813-0.848), compared to only 0.633 (95% CI 0.592-0.673) in those with known HF (n = 803, 19%) (z score = 8.771, p < 0.001, Figure). The sensitivity and NPV of HEART score among those without HF were 87.4% and 95.3%, compared to 81.2% and 73.3%, respectively, among those with known HF. Conclusion Our findings suggest that the prognostic value of HEART score for predicting 30-day MACE is inferior and suboptimal in patients with known HF evaluated for chest pain at the emergency department compared to their counterparts. These findings emphasize the need for more tailored risk assessment and management strategies in this specific patient population. Further research is warranted to better understand the limitations and potential enhancements of the HEART score in patients with HF.Classification Performance of HEART score

Natural language processing identification of adverse events on immunotherapy clinical trials: Accuracy compared to trial reporting and physician review.

571 Background: Adverse event (AE) assessment is an important component of clinical trials and routine clinical care. Natural language processing (NLP) approaches may facilitate automated methods to identify AEs, potentially allowing both early intervention and streamlined trial AE documentation. We previously demonstrated that an NLP pipeline had high accuracy for identifying toxicities associated with radiotherapy from clinical notes compared to physician reviewers. This study aims to evaluate this pipeline in comparison with clinical trial reporting and physician reviewers. Methods: We identified a total of 53 encounters across 20 patients enrolled over four immunotherapy trials with both corresponding notes and associated AEs. Two independent physician reviewers (DK & LN) identified symptoms documented in notes using a National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0 reporting tool. Likewise, a previously described NLP pipeline based on Apache clinical Text Analysis Knowledge Extraction System was used on the notes to identify CTCAE symptoms. NLP-extracted symptoms and physician reviewer identification were assessed for sensitivity and specificity compared to trial-reported AEs. Cohen kappa score was used to assess inter-rater reliability between physician reviewers. Results: The five most reported trial AEs were diarrhea (17%), fever (17%), fatigue (15%), constipation (13.2%), and nausea (11.3%) (Table).Except for anorexia, NLP had greater or equal sensitivity for reported AEs compared to both reviewers (R1, R2). However, both reviewers had greater specificity than NLP. Between the reviewers, vomiting and anorexia had the highest Cohen kappa scores (1, 0.88), while fever and constipation had the lowest (0.31, 0.47, Table). Conclusions: NLP can detect toxicity symptoms from clinical notes with higher or equal sensitivity than physician reviewers, while physician reviewers had greater specificity. These results indicate that our NLP approach over-identifies symptoms while manual reviewers are more conservative in their approach. Therefore, NLP may best be served in the screening setting. NLP may also help reduce reviewer inter-rater variability, particularly in fever, constipation, and fatigue symptoms.[Table: see text]

Bridging the Gap Between Urological Research and Patient Understanding: The Role of Large Language Models in Automated Generation of Layperson's Summaries.

This study assessed ChatGPT's ability to generate readable, accurate, and clear layperson summaries of urological studies, and compared the performance of ChatGPT-generated summaries with original abstracts and author-written patient summaries to determine its effectiveness as a potential solution for creating accessible medical literature for the public. Articles from the top 5 ranked urology journals were selected. A ChatGPT prompt was developed following guidelines to maximize readability, accuracy, and clarity, minimizing variability. Readability scores and grade-level indicators were calculated for the ChatGPT summaries, original abstracts, and patient summaries. Two MD physicians independently rated the accuracy and clarity of the ChatGPT-generated layperson summaries. Statistical analyses were conducted to compare readability scores. Cohen's κ coefficient was used to assess interrater reliability for correctness and clarity evaluations. A total of 256 journal articles were included. The ChatGPT-generated summaries were created with an average time of 17.5 (SD 15.0) seconds. The readability scores of the ChatGPT-generated summaries were significantly better than the original abstracts, with Global Readability Score 54.8 (12.3) vs 29.8 (18.5), Flesch Kincade Reading Ease 54.8 (12.3) vs 29.8 (18.5), Flesch Kincaid Grade Level 10.4 (2.2) vs 13.5 (4.0), Gunning Fog Score 12.9 (2.6) vs 16.6 (4.1), Smog Index 9.1 (2.0) vs 12.0 (3.0), Coleman Liau Index 12.9 (2.1) vs 14.9 (3.7), and Automated Readability Index 11.1 (2.5) vs 12.0 (5.7; P < .0001 for all except Automated Readability Index, which was P = .037). The correctness rate of ChatGPT outputs was >85% across all categories assessed, with interrater agreement (Cohen's κ) between 2 independent physician reviewers ranging from 0.76-0.95. ChatGPT can create accurate summaries of scientific abstracts for patients, with well-crafted prompts enhancing user-friendliness. Although the summaries are satisfactory, expert verification is necessary for improved accuracy.

Abnormalities on baseline chest imaging are risk factors for immune checkpoint inhibitor associated pneumonitis

BackgroundChronic lung disease is a proposed risk factor for immune checkpoint inhibitor pneumonitis (ICI-pneumonitis); however, data is sparse regarding the impact of pre-existing lung disease and baseline chest imaging abnormalities on the risk of developing ICI-pneumonitis. MethodsWe conducted a retrospective cohort study of patients with ICI treatment for cancer from 2015 to 2019. ICI-pneumonitis was determined by the treating physician with corroboration via an independent physician review and exclusion of alternative etiologies. Controls were patients treated with ICI without a diagnosis of ICI-pneumonitis. Fisher's exact tests, Student's t-tests, and logistic regression were used for statistical analysis. ResultsWe analyzed 45 cases of ICI-pneumonitis and 135 controls. Patients with abnormal baseline chest CT imaging (emphysema; bronchiectasis; reticular, ground glass and/or consolidative opacities) had increased risk for ICI-pneumonitis (OR 3.41, 95%CI: 1.68–6.87, p = 0.001). Patients with gastroesophageal reflux disease (GERD) (OR 3.83, 95%CI: 1.90–7.70, p = < 0.0001) also had increased risk for ICI-pneumonitis. On multivariable logistic regression, patients with abnormal baseline chest imaging and/or GERD remained at increased risk for ICI-pneumonitis. Eighteen percent of all patients (32/180) had abnormal baseline chest CT consistent with chronic lung disease without a documented diagnosis. ConclusionPatients with baseline chest CT abnormalities and GERD were at increased risk for developing ICI-pneumonitis. The large proportion of patients with baseline radiographic abnormalities without a clinical diagnosis of chronic lung disease highlights the importance of multidisciplinary evaluation prior to ICI initiation.

Evaluation of insertable cardiac monitor placement and safety in the LUX-Dx PERFORM study

Abstract Funding Acknowledgements Type of funding sources: Private company. Main funding source(s): Boston Scientific Corporation Background The LUX-Dx PERFORM Study is designed to evaluate safety and performance of the LUX-Dx insertable cardiac monitor (ICM) in a general patient population. Enrollment and device insertions are complete, and all patients have completed 30 days of follow-up. This abstract describes the study population, characterizes device insertion, and reports on preliminary data for ICM system-related complications. Methods The LUX-Dx PERFORM study is a prospective, multi-center, single arm, post-market, observational study. The ICM system-related complication-free rate (CFR) at 30 days post-insertion was calculated using Kaplan-Meier methodology and the 97.5% one-side lower confidence limit (LCL) was compared to the prespecified performance target of 94%. All ICM system-related adverse events were adjudicated by independent physician reviewers. Results 727 patients were enrolled at 24 centers in the United States from March 2021 to May 2022. The study population was 49% male, 91% white and 66+/-14 years old. 717 patients had device insertions and were successfully registered in the LATITUDE Clarity data management system. There were 9 withdrawals prior to insertion and 1 aborted procedure due to deployment difficulty. ICM insertion was performed in-hospital 76% of the time (N=547) and in-clinic 24% of the time (N=171). 96% were de novo device insertions. A variety of closure techniques were used including surgical glue (62%), adhesive strips (45%), sutures (42%), and staples (9%). Median procedure time was 4 minutes (range 1 - 37). There were 4 ICM system-related complications in the first 30 days (CFR 99%, LCL 99%) which meets the acute safety performance goal. The system-related complications include 1 case of ICM deployment difficulty, 1 case of device expulsion three days post insertion, and 2 infections that were treated with oral antibiotics and resolved without further mitigation. Conclusion The LUX-Dx ICM can be inserted quickly, in both hospital and clinic settings, with a very low complication rate.

Abstract 10532: Physician Interpretation and Characterization of Intracardiac Electrograms at the Time of Non-Cardiac Death

Introduction: Electrograms (EGMs) generated by implantable cardiac devices at the time of non-cardiac death may have artifact from non-arrhythmic sources, such as coagulated blood and air bubbles. While few studies have described the nature of terminal EGMs in non-cardiac death, it is clinically and medicolegally important to characterize these EGMs to elucidate events that may otherwise be misinterpreted as device failure. Here we investigated terminal EGM features that may aid clinicians in discerning cardiac from non-cardiac death. Methods: Terminal EGMs were analyzed by independent physician reviewers. Deaths were adjudicated as non-cardiac based on direct clinical data at the time of death using a modified Cardiac Arrhythmia Suppression Trial approach. In total, 16 non-cardiac terminal EGMs were identified and compared to a control cohort of true arrhythmic events. Using a subset of identified EGMs, an 8-question survey was administered to electrophysiologists blinded to cause of death. Several variables were identified as important for the correct classification of EGMs. The statistical performance of each variable for detecting non-cardiac death and true arrhythmias in our sample was evaluated. These results were shared, and the survey was readministered. Results: In our sample, absence of organized atrial activity had a sensitivity (SN) of 78.5%, specificity (SP) of 100%, and positive predictive value (PPV) of 100% for non-cardiac terminal EGMs. Cycle length &lt;130 ms and absence of discernible deflections both had SPs and PPVs of 100% for non-cardiac death but were less sensitive (60% and 20%, respectively). An abrupt change following therapy and response to therapy both had SNs, SPs, and PPVs of 100% for true arrhythmias. Survey response rate was 68.8% and 62.5% for the pre- and post-survey, respectively. Pre-survey scores ranged from 50 – 87.5% correct with a mean of 72.7%. Post-survey scores ranged from 75 – 100% with a mean of 86.3% (p&lt; 0.01). Conclusions: There is variability and inaccuracy among expert physicians' interpretation of EGMs during non-cardiac death. The variables identified in this study will aid in the development of a clinical risk score used to discern non-cardiac death and true device malfunction based on terminal EGMs.

Atrial fibrillation associated with heart failure treated by a 2-lead CRT-DX system (BIO-AffectDX): Study design and clinical protocol.

BackgroundEvidence to support use of cardiac resynchronization therapy (CRT) among patients with both heart failure (HF) and atrial fibrillation (AF) is largely limited to retrospective or post hoc subanalyses. Data from a prospectively enrolled and contemporary cohort are needed.ObjectiveWe aim to better characterize the changes from baseline in HF patients with concomitant AF subsequently implanted with a 2-lead CRT-DX system capable of sensing in the atrium, aggregating diagnostics, and delivering CRT therapy. The primary objective of this study is to evaluate the percentage of all HF subjects with an improvement in a clinical composite score from pre-CRT implant to 12 months.MethodsThe study is a US-based, prospective, observational multicenter clinical trial conducted at up to 50 sites and enrolling approximately 400 subjects with a follow-up period of 1 year. Multiple subject assessments, atrial rhythm status, and device interrogation will be collected at follow-up visits occurring at 3, 6, and 12 months postimplant.ResultsA Clinical Events Committee will adjudicate subject HF events, arrhythmia events, death events, and all device-classified ventricular tachycardia and ventricular fibrillation episodes with treatment that are collected throughout the follow-up period. Their decisions are based on independent physician review of the data from sites and device interrogation.ConclusionThe BIO-AffectDX study aims to provide further insight into the expected outcomes from CRT treatment in patients with HF and AF.

Assessment of primary prevention patients receiving an ICD - Systematic evaluation of ATP: APPRAISE ATP.

BackgroundThe value of antitachycardia pacing (ATP) in the overall cohort of primary prevention patients who receive implantable cardioverter-defibrillators (ICDs) remains uncertain. ATP success reported in prior trials potentially included a large number of patients receiving unnecessary ATP for arrhythmias that may have self-terminated owing to the prematurity of the intervention. Although some patients derive benefit from initial ATP in terminating rapid ventricular arrhythmias and thereby preventing shocks, there are limited data allowing us to identify those patients a priori.ObjectiveThe purpose of APPRAISE ATP is to understand the role of ATP in primary prevention patients currently indicated for ICD therapy in a large prospective randomized controlled trial with modern programming parameters.MethodsThe study is a global, prospective, randomized, multicenter clinical trial conducted at up to 150 sites globally, enrolling approximately 2600 subjects The primary endpoint of the trial is time to first all-cause shock in a 2-arm study with an equivalent study design in which the incidence of all-cause shocks will be compared between primary prevention subjects programmed with shocks only vs subjects programmed to standard therapy (ATP and shock).ResultsAn Electrogram and Device Interrogation Core Laboratory will review interrogation data to determine primary endpoints that occur in APPRAISE ATP. Their decisions are based on independent physician review of the data from device interrogation.ConclusionThe ultimate purpose of the study is to aid clinicians in the selection of ICD technologies based on hard endpoint evidence across the spectrum of indications for primary prevention implantation.

Assessing the International Transferability of a Machine Learning Model for Detecting Medication Error in the General Internal Medicine Clinic: Multicenter Preliminary Validation Study.

BackgroundAlthough most current medication error prevention systems are rule-based, these systems may result in alert fatigue because of poor accuracy. Previously, we had developed a machine learning (ML) model based on Taiwan’s local databases (TLD) to address this issue. However, the international transferability of this model is unclear.ObjectiveThis study examines the international transferability of a machine learning model for detecting medication errors and whether the federated learning approach could further improve the accuracy of the model.MethodsThe study cohort included 667,572 outpatient prescriptions from 2 large US academic medical centers. Our ML model was applied to build the original model (O model), the local model (L model), and the hybrid model (H model). The O model was built using the data of 1.34 billion outpatient prescriptions from TLD. A validation set with 8.98% (60,000/667,572) of the prescriptions was first randomly sampled, and the remaining 91.02% (607,572/667,572) of the prescriptions served as the local training set for the L model. With a federated learning approach, the H model used the association values with a higher frequency of co-occurrence among the O and L models. A testing set with 600 prescriptions was classified as substantiated and unsubstantiated by 2 independent physician reviewers and was then used to assess model performance.ResultsThe interrater agreement was significant in terms of classifying prescriptions as substantiated and unsubstantiated (κ=0.91; 95% CI 0.88 to 0.95). With thresholds ranging from 0.5 to 1.5, the alert accuracy ranged from 75%-78% for the O model, 76%-78% for the L model, and 79%-85% for the H model.ConclusionsOur ML model has good international transferability among US hospital data. Using the federated learning approach with local hospital data could further improve the accuracy of the model.

347. Etiologies in a Cohort of Pediatric Patients Who Underwent CSF Metagenomic Next Generation Sequencing

BackgroundThe differential diagnosis in pediatric patients presenting with concern for CNS infections and/or autoimmune disorders is broad. Despite recent advances in diagnostic modalities, many cases may remain undiagnosed. For example, approximately 50% of pediatric patients with encephalitis do not have an identified etiology. Use of metagenomic next-generation sequencing (mNGS) may improve the diagnostic yield. This study evaluated etiologies in a cohort of pediatric patients who underwent CSF mNGS.MethodsRetrospective cohort study of all hospitalized patients < 21-years-old who underwent CSF mNGS at a tertiary pediatric hospital from June, 2017 - February, 2020. Final diagnosis was assigned by two independent study physician reviewers (pediatric infectious disease and neurologist) based on documentation including discharge summaries, consult notes, and subsequent clinic notes where available.ResultsThirty-seven patients (59% female, median age 9 (1–17) years) were identified (21 with encephalitis). Twenty-six (70%) had a definite diagnosis – 10 (27%) infectious, 11 (30%) autoimmune, 5 (14%) other. The most common etiology was anti-MOG antibody associated meningoencephalitis (n=4, 11%). Among infections, Powassan virus encephalitis (n=3, 8%) was most common; other infectious etiologies included EBV, neuroborreliosis, rubella, and Eastern Equine encephalitis. Eight (22%) had a positive result on CSF mNGS; 7 were clinically significant including change in management in 5 of 8 (63%) patients.ConclusionIn this cohort of pediatric patients who underwent CSF mNGS, an etiology was identified in 70%. Eight patients had a positive result on mNGS which resulted in change in management for the majority of patients. These data suggest that CSF mNGS is high-yield and impacts clinical care. However, given the significant cost of mNGS, future directions include cost analyses to determine when and in whom CSF mNGS should be sent.DisclosuresAsim A. Ahmed, MD, Karius (Employee)

Evaluating YouTube as a Source of Patient Information for Functional Endoscopic Sinus Surgery.

To evaluate the quality of information presented on YouTube regarding functional endoscopic sinus surgery (FESS) for patients. YouTube was searched using FESS-specific keywords under the setting of "relevance." The first 50 videos from each keyword were reviewed and analyzed by 2 independent physician reviewers. Videos not related to FESS and duplicates were excluded. Outcome measures included the modified DISCERN score (range 0-5), the Journal of the American Medical Association (JAMA) benchmark criteria (range: 0-4), a novel scoring checklist for FESS assessing usefulness (range: 0-16), and the Video Power Index (VPI). Intraclass correlation coefficient (ICC) was calculated. Of the 200 videos identified, 95 videos were analyzed after exclusions. Videos had an average VPI of 40.8 and SD 133.2. Average scores from the 3 objective checklists among all videos were low: modified DISCERN: 1.91, SD: 1.15; JAMA benchmark: 1.91, SD: 0.76; and FESS score: 3.54, SD: 1.77. The ICC between the 2 independent reviewers was excellent for all 3 checklists. We noted significant positive Pearson correlation between all 3 checklist scores (P < .001). In between-group comparisons of mean scores, there was significantly higher DISCERN and JAMA scores for videos from university/professional organizations, as compared to videos from medical advertising/for-profit companies and independent users. There were no significant differences in FESS scores noted between the 3 groups. There were overall low scores across the modified DISCERN, JAMA benchmark criteria, and FESS scoring checklists, reflecting the poor quality of YouTube videos as a source of patient information for FESS.

A Meta-Analysis on the Effects of Hydroxychloroquine on COVID-19.

IntroductionSince December 2019, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has rapidly spread throughout the world with a large medical and economic impact. On March 12, 2020, the World Health Organization (WHO) classified SARS-CoV-2 as a pandemic. As a result of this worldwide public health crisis, politicians, elected officials, and healthcare professionals emergently began trialing hydroxychloroquine (HCQ) in efforts to treat and prevent the transmission of the virus. This meta-analysis was performed to assess the effects of HCQ on patients with COVID-19.Methods This meta-analysis adheres to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRIMA) guidelines. Selected articles published between December 2019 and July 2020 were found utilizing the following search engines: PubMed, Google Scholar, Cochrane Library, DisasterLit, Clinicaltrials.gov, Medrxiv, and Embase. Two independent physician reviewers screened eligible articles that met the inclusion and exclusion criteria of the analysis. The outcome measures analyzed were mortality rate, rate of disease progression/improvement, rate of disease severity, and adverse effects of treatment. Six out of 14 studies that met the study’s eligibility criteria were selected and further analyzed, with a total of 381 participants (n= 381).ConclusionFrom the studies analyzed, it was found that groups treated with HCQ had an overall mortality rate that was 2.5 times greater than that of the control group. HCQ treated patients had higher rates of adverse clinical outcomes and side effects compared with the control populations. Lastly, there was a 1.2 times higher rate of improvement in the group of HCQ treated patients with mild to moderate symptoms as compared to the control group.

Real-World Experience With 100 Consecutive Patients Undergoing Neck Contouring With ATX-101 (Deoxycholic Acid): An Updated Report With A 2-Year Analysis.

BACKGROUNDDeoxycholic acid (DCA; ATX-101) injection was approved for the treatment of mild-to-moderate convexity associated with submental fat in 2015.OBJECTIVETo evaluate the experience with DCA injections in a clinical practice setting.MATERIALS AND METHODSThis ongoing, prospective, single-center, single-arm, observational study evaluated 100 consecutive patients treated with subcutaneous DCA (2 mg/cm2) injections (maximum 6 sessions at ≥1-month intervals). Treatment response was assessed using the clinician-reported submental fat rating scale (CR-SMFRS) and confirmed by independent physician review of photographs at 1 and 5 to 7 weeks after treatment.RESULTSSince the previous published report, 17 patients have undergone additional treatment sessions, with a total of 100 patients having undergone 195 treatment sessions: 41, 36, 14, 6, 2, and 1 patient underwent 1, 2, 3, 4, 5, and 6 sessions, respectively. Overall, 91.7% of patients in the single treatment session group and 100% in the multiple treatment session group had an improvement of ≥1 point on the CR-SMFRS. The mean (SD) duration of local edema, numbness, and tenderness after treatment was 7.1 (5.1), 27.9 (11.3), and 3.5 (3.5) days, respectively.CONCLUSIONDeoxycholic acid injections were generally well tolerated, and ≥2 treatment sessions were required to achieve the desired aesthetic goal in a private practice setting.

A Medical Incapacity Hold Policy Reduces Inappropriate Use of Involuntary Psychiatric Holds While Protecting Patients From Harm

The use of involuntary psychiatric holds (IPH) to detain patients who lack the capacity to make health care decisions due to nonpsychiatric conditions is common. While this practice prevents patient harm, it also deprives civil liberties, risks liability for false imprisonment, and may hinder disposition. Medical incapacity hold (MIH) policies, which establish institutional criteria and processes for detaining patients who lack capacity but do not meet criteria for an IPH, provide a potential solution. A retrospective chart review was conducted on adult medical/surgical inpatients placed on an IPH or MIH over the 1-year periods before and after implementation of a MIH policy at an academic medical center. The primary outcome was frequency of IPH utilization in patients who did not qualify for an IPH as determined by 2 independent physician reviewers. A Cohen's kappa was calculated to determine inter-rater reliability. Differences in patient demographics and outcomes were compared using a Student's t-test, Wilcoxon rank-sum test, and Pearson chi-square test (α = 0.05). The Cohen's kappa was 0.72 indicating substantial agreement. Seventy MIHs were placed after implementation (mean duration 4.3 days). Before MIH implementation, 17.6% of IPHs were placed on non-qualifying patients, which decreased to 3.9% following MIH implementation (p < 0.01). The average length of stay for patients on an IPH or MIH did not change following MIH implementation. No instances of patient elopement, grievances, or litigation were found. MIH policies benefit both patients lacking capacity and the health care systems seeking to protect them while avoiding inappropriate use of IPHs.

Abstract 67: Real-World Experience with 100 Consecutive Patients Undergoing Injection Adipocytolysis for Neck Contouring with ATX-101 (Deoxycholic Acid): An Updated Report with 2-Year Analysis

PURPOSE: In 2015, deoxycholic acid (DCA) injection was approved for treatment of mild-to-moderate convexity associated with submental fat. The efficacy and safety of submental DCA injection have been demonstrated in four phase 3 randomized controlled trials (RCTs), however, critical assessment of DCA injection in conventional clinical practice is lacking. In a previous report, we presented initial findings from our experience with 100 consecutive patients administered submental DCA. This study describes and evaluates real-world experience with submental DCA injection in a clinical practice setting, and provides an update to our previous report, accounting for additional treatment sessions during long-term follow-up. METHODS: This prospective, single-arm, observational study was conducted at a single clinic (private practice) between June 2015 and June 2017. Experience through February 2016 was previously published. The study involved 100 consecutive patients, aged between 18 and 80 years, seeking improvement in convexity/fullness associated with submental fat. Treatment involved DCA injection to the preplatysmal submental fat using an area-adjusted DCA dose of 2 mg/cm2, with up to 75 injections (0.2 mL per injection [maximum, 15 mL]) per treatment session for a maximum of 6 sessions. Treatment response was assessed using the clinician-reported submental fat rating scale CR-SMFRS (0 = absent; 1 = mild; 2 = moderate; 3 = severe; and 4 = extreme) and confirmed by independent physician review of photographs at 1 and 5 to 7 weeks posttreatment. Treatment response was defined as an improvement of ≥1 point. AEs, including injection-site AEs such as local edema, numbness, and tenderness were monitored at each follow-up visit. Patient demographics, response, and safety were compared between patients who underwent single versus multiple treatment sessions. RESULTS: Since the prior published report, 17 patients have undergone additional treatment sessions. Overall, one hundred patients have had 195 treatment sessions: 41, 36, 14, 6, 2, and 1 patient had 1, 2, 3, 4, 5, and 6 sessions, respectively. In the multiple-treatment-session (MTS) group, most (36/59 [61.0%]) patients had 2 sessions; 14 (23.7%) had 3 sessions, 6 (10.2%) had 4 sessions, 2 (3.4%) had 5 sessions, and 1 (1.7%) had 6 sessions. A mean (SD) of 6.7 (2.3) mL of DCA was administered per treatment session, with significantly more DCA administered to the MTS than single-treatment-session (STS) group (6.8 [2.3] vs 6.1 [2.2] mL/session; p = .049). Overall, 33 of 36 (91.7%) patients in the STS group and all 59 (100.0%) patients in the MTS group had an improved CR-SMFRS score by ≥1 point. Local edema, numbness, and tenderness were reported for a mean (SD) of 7.1 (5.1), 27.9 (11.3), and 3.5 (3.5) days post-treatment, respectively. CONCLUSIONS: Longer-term follow-up of submental DCA injections demonstrated that patients will likely require ≥2 sessions to achieve the desired aesthetic goal in a private practice setting. Both single- and multiple-treatment sessions were generally well tolerated. S.M. Shridharani:; Allergan.; Galderma.; Merz.; Sientra. G.M. Tisch: None.

The Impact of Automated Notification on Follow-up of Actionable Tests Pending at Discharge: a Cluster-Randomized Controlled Trial.

Follow-up of tests pending at discharge (TPADs) is poor. We previously demonstrated a twofold increase in awareness of any TPAD by attendings and primary care physicians (PCPs) using an automated email intervention OBJECTIVE: To determine whether automated notification improves documented follow-up for actionable TPADs DESIGN: Cluster-randomized controlled trial SUBJECTS: Attendings and PCPs caring for adult patients discharged from general medicine and cardiology services with at least one actionable TPAD between June 2011 and May 2012 INTERVENTION: An automated system that notifies discharging attendings and network PCPs of finalized TPADs by email MAIN MEASURES: The primary outcome was the proportion of actionable TPADs with documented action determined by independent physician review of the electronic health record (EHR). Secondary outcomes included documented acknowledgment, 30-day readmissions, and adjusted median days to documented follow-up. Of the 3378 TPADs sampled, 253 (7.5%) were determined to be actionable by physician review. Of these, 150 (123 patients discharged by 53 attendings) and 103 (90 patients discharged by 44 attendings) were assigned to intervention and usual care groups, respectively, and underwent chart review. The proportion of actionable TPADs with documented action was 60.7 vs. 56.3% (p = 0.82) in the intervention vs. usual care groups, similar for documented acknowledgment. The proportion of patients with actionable TPADs readmitted within 30days was 22.8 vs. 31.1% in the intervention vs. usual care groups (p = 0.24). The adjusted median days [95% CI] to documented action was 9 [6.2, 11.8] vs. 14 [10.2, 17.8] (p = 0.04) in the intervention vs. usual care groups, similar for documented acknowledgment. In sub-group analysis, the intervention had greater impact on documented action for patients with network PCPs compared with usual care (70 vs. 50%, p = 0.03). Automated notification of actionable TPADs shortened time to action but did not significantly improve documented follow-up, except for network-affiliated patients. The high proportion of actionable TPADs without any documented follow-up (~ 40%) represents an ongoing safety concern. NCT01153451.

Evaluating Atypical Features of Femur Fractures: How Change in Radiological Criteria Influenced Incidence and Demography of Atypical Femur Fractures in a Community Setting.

Identification of atypical femoral fractures (AFFs) can be challenging. To assist in the radiological assessment, an American Society for Bone and Mineral Research (ASBMR) Task Force developed a case definition for AFFs in 2010, revising it in 2013. How the revised definition performs in a community setting compared with the 2010 definition is unknown. We applied the 2013 criteria to 372 femoral fractures that occurred between January 1, 1996, and June 30, 2009, employing two independent expert physician reviewers. We used radiographs that had been categorized in a previous study on the incidence of atypical fractures using 2010 ASMBR criteria (BEAK1). In this follow-up study (BEAK2), the same reviewers reviewed all previously identified femoral shaft fractures (FSFs) (n = 197) and distal femur fractures (n = 131) plus a 15% random sample of intertrochanteric fractures (n = 49). After initial review, agreement between the two reviewers ranged from 63% to 100% for specific features, and 84% of radiographs received the same overall classification. Fewer fractures met the 2013 compared with 2010 ASMBR case definition of AFFs (37 per 2013 criteria versus 74 per 2010 criteria). Forty-three radiographs (58%) categorized as AFFs according to 2010 criteria were no longer AFFs when 2013 criteria were applied, and an additional 12 non-atypical FSFs according to 2010 criteria were reclassified as AFFs according to 2013 criteria. The major cause of AFF reclassification was the change in the definition of transverse configuration. The modification of the comminution, non-traumatic, and periosteal/endosteal thickness criteria resulted in the reclassification of non-atypical FSFs to AFFs. Incidence rate of AFFs according to 2013 ASBMR criteria was lower overall during the 13 years of observation than when the 2010 ASBMR criteria were applied, although we saw a slight increase starting in 2000. As in BEAK1, we found that those with AFFs were younger, more often female, and had a higher exposure rate to bisphosphonates than those with non-atypical FSFs. As we continue to unravel the demographics of those who suffer from AFFs, our study adds information about how the change in criteria influences epidemiological work. © 2017 American Society for Bone and Mineral Research.

Important role of physicians in addressing psychological aspects of interstitial cystitis/bladder pain syndrome (IC/BPS): a qualitative analysis

Interstitial cystitis/bladder pain syndrome (IC/BPS) is a poorly understood source of chronic pain causing significant morbidity, with variable treatment success. Despite the need to understand patient perspectives in chronic pain, there is a paucity of qualitative data for IC/BPS. We aimed to acquire information regarding patient experience with IC/BPS symptoms and with their medical care to elicit suggestions to improve patient satisfaction with that care. Fifteen women with IC/PBS participated in a total of four focus groups. Sessions were recorded and transcribed and information deidentified. Focus groups were conducted until thematic saturation was reached. All transcripts were coded and analyzed by a minimum of three independent physician reviewers. Investigators identified emergent themes and concepts using grounded-theory methodology. Participant's mean age was 52.6years, with an average IC/BPS duration of 6.3years. Thematic saturation was reached after four focus groups. We identified three emergent patient experience concepts: IC/PBS is debilitating, the disease course is unpredictable and unrelenting, and patients experience significant isolation. Importantly, suicidal ideation was expressed in each group. Patients voiced strong preference for physicians who provided education regarding the condition, an array of treatment options, organized treatment plans, and optimism and hope regarding treatment outcomes. Our study presents novel findings of the importance of patient-physician interaction in IC/BPS and reinforces the tremendous disability and burden of this disease, which frequently manifests in suicidal ideation. Patients preferred organized treatment plans with diverse choices and providers who offered hope in dealing with their condition.