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The NIDDK Takes on the Complications of Type 1 Diabetes: The Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) Study
No full textIn the Diabetes Control and Complications Trial (DCCT) (1983-1993), intensive therapy aimed at near-normal glycemia was compared with conventional therapy in 1,441 adolescent and adult participants with type 1 diabetes (T1D) over a mean follow-up of 6.5 years. The primary DCCT results, reported in 1993, demonstrated the benefits of intensive therapy (mean HbA1c ∼7%) compared with conventional therapy (HbA1c ∼9%) in reducing the risk of development and progression of microvascular complications by 35%-76%. HbA1c \u3c7% was adopted worldwide as the therapeutic target for T1D. Subsequently, the Epidemiology of Diabetes Interventions and Complications (EDIC) study (1994-present) was initiated as the observational follow-up of the DCCT cohort. EDIC has shown that the early beneficial effects of intensive versus conventional therapy on complications persisted for ∼10 years after the convergence of HbA1c levels in the two groups during EDIC-a novel concept termed metabolic memory. During EDIC, prior intensive therapy was also shown to reduce the risk of severe microvascular complications, cardiovascular disease, mortality, and, recently, of age-related outcomes including cognitive impairment, bone loss, and reduced mobility. The DCCT/EDIC cohort is the most extensively studied T1D cohort in history. The participants have been followed and deeply phenotyped for 95% of their diabetes durations and 65% of their lifespans. Throughout its 40+ years, funded by and in close collaboration with the National Institute of Diabetes and Digestive and Kidney Diseases, DCCT/EDIC has generated results that have guided treatment priorities in T1D and led to improved survival and quality of life for millions of people with T1D worldwide
Aetiologies, neuroradiological features, and risk factors for mortality and long-term neurosequelae of febrile coma in Malawian children: a prospective cohort study
No full textBACKGROUND: Children in febrile coma in Africa are frequently hospitalised, with poorer outcomes than those in high-income settings. Cerebral malaria is historically the most common cause of febrile coma. Due to limited diagnostic and radiological resources and a decrease in malaria prevalence, there might be under-recognition of non-malarial coma. However, prospective data are scarce. We aimed to determine causes, neuroradiological features, risk factors for mortality, and neurosequelae of children in febrile coma in Malawi. METHODS: In this prospective cohort study, we enrolled children in a coma (Blantyre Coma Scale score ≤2) who were aged between 3 months and 15 years at Queen Elizabeth Central Hospital, Blantyre, Malawi. We used pathogen-specific PCR analysis of blood and cerebrospinal fluid for 15 pathogens including Streptococcus pneumoniae, Neisseria meningitidis, Haemophilus influenzae, Salmonella spp, non-typhoidal Salmonella, Salmonella enterica serotype Typhi (S Typhi), Klebsiella spp, Escherichia coli, Mycobacterium tuberculosis (also using GeneXpert), Streptococcus agalactiae, herpes simplex virus (types 1 and 2), varicella zoster virus, cytomegalovirus, enteroviruses, and SARS-CoV-2; microscopy for malaria; admission brain MRI to enhance the diagnosis of cause and identify brain injury, swelling, and any other complications; and electroencephalography tracings were used identify subclinical seizures or non-convulsive status epilepticus. Assessment of malarial retinopathy was performed by a trained ophthalmologist. We used regression models to estimate risk factors for (and the difference in) 30-day mortality and 180-day neurosequelae (outcome assessed in-person) between children with non-malarial coma and cerebral malaria. FINDINGS: Between Jan 31, 2018, and June 30, 2021, we recruited 352 children with febrile coma. Cerebral malaria was the most common cause (in 231 [66%] of 352 children). Pathogenic diagnosis was possible in 289 (82%) of 352 children. Co-infection was identified in 63 (27%) of 231 children with cerebral malaria, of which 49 (78%) were bacterial. The most common non-malarial causes of coma were meningitis (48 [14%] of 352 children) and encephalitis (24 [7%] of 352); 32 (9%) cases had an unknown cause. Compared with standard cultures, PCR significantly increased pathogen diagnosis (p\u3c0·0001), with the highest yield in patients with meningitis (seven [15%] of 48 vs 30 [63%] of 48). S pneumoniae (n=44) and non-typhoidal salmonella or S Typhi (n=24) were the most frequently detected bacterial pathogens. Brain parenchymal abnormalities were identified on MRI in most children with febrile coma (165 [92%] of 178), and were significantly more common in children with non-malarial coma (68 [100%] of 68]) than cerebral malaria (98 [89%] of 110; p\u3c0·0001). Overall, at 30 days after discharge, death (69 [21%] of 323) or any neurological impairment (163 [50%] of 323) were common, but poorer long-term outcomes were more frequent following non-malarial coma than cerebral malaria (death at 30 days: 32 [28%] of 114 vs 37 [18%] of 209, p=0·029; severe neurological impairment at 180 days: 19 [17%] of 114 vs 15 [7%] of 209, p=0·0079). Children who had cerebral malaria with CNS co-infection had higher mortality (ten [37%] of 27) than those with cerebral malaria alone (19 [12%] of 154, p=0·0033). INTERPRETATION: Despite malaria control efforts, cerebral malaria remains the most common cause of febrile coma in Malawi. However, non-malarial coma causes a greater disease burden (death and disability), and a higher case-fatality rate was observed in non-malarial coma and cerebral malaria with non-malarial co-infection than cerebral malaria alone. To adequately treat severe invasive bacterial infections, that are frequently not detected in routine clinical practice, commencing empirical antimicrobials in all children in febrile coma, including those with cerebral malaria, could and should be rapidly implemented across Africa and must be considered. The study highlights the value of molecular diagnostics and imaging to guide diagnosis. The frequent findings of brain abnormalities from imaging at admission emphasises the need for earlier escalation of children with febrile coma to specialist care. Further work is needed to develop feasible molecular and radiological diagnostics for their successful deployment across the continent. Implementation of these methods could improve diagnosis and outcomes for children with febrile coma in Africa. FUNDING: Wellcome Trust TRANSLATIONS: For the Chichewa, French and Portuguese translations of the abstract see Supplementary Materials section
Anorectal Malformation Fistula Evaluation May Aid in Hirschsprung Diagnosis
No full textINTRODUCTION: Concurrence of Hirschsprung disease (HD) and anorectal malformation (ARM) is rare, but early diagnosis is important for proper management. The aim of this study was to define the expected histological findings of rectal fistulae in ARM and to identify findings that may raise suspicion for concurrent HD. METHODS: Eighty-six patients with ARM from a single institution were studied. Pathology reports as well as randomly selected fistula specimens were evaluated for the presence of ganglion cells at a single institution. An additional query of the Pediatric Colorectal and Pelvic Learning Consortium database was performed to examine clinical features of patients with HD and ARM. RESULTS: Patients represented the spectrum of ARM, with perineal fistula being the most common. Ganglion cells were present in 78 of 86 (91%) specimens, hypoganglionosis in 5 of 86 specimens (6%), and absent in 3 of 86 (4%) specimens. Of the patients with absence of ganglion cells in their fistula specimens, 2 of 3 (66%) also carried a diagnosis of Trisomy 21. Within the Pediatric Colorectal and Pelvic Learning Consortium database, we identified 12 patients with both ARM and HD out of 1726 ARM subjects (0.7% of ARM patients). Among this group of patients, 33% (n = 4) had chromosomal anomalies. CONCLUSIONS: The majority of fistula specimens from patients with ARMs contain ganglion cells. Absence of ganglion cells in patients with ARM should prompt suspicion for HD. This association may be more common in patients with chromosomal anomalies
Remote presentation of nivolumab-induced bullous pemphigoid in hepatocellular carcinoma
No full textA man in his 70s with a history of unresectable hepatocellular carcinoma (HCC) treated with nivolumab presented with a blistering rash 14 months after nivolumab initiation. Biopsies and direct immunofluorescence confirmed the diagnosis of bullous pemphigoid (BP). BP is an autoimmune skin disorder in which autoantibodies bind to the dermal-epidermal junction. It is a rare sequela of programmed cell death protein-1 (PD-1) inhibitors that can develop after treatment initiation and typically resolve soon after discontinuation. Most cases are reported in melanoma and non-small cell lung cancers, and rarely in HCC irrespective of the timing of onset. We describe a rare presentation of remote BP with PD-1 inhibitor use in HCC. PD-1 inhibitor-induced BP is a rare cutaneous immune-related adverse event, and this case highlights the variability in onset and chronicity
The effect of ridesharing services on motor vehicle crash outcomes: A systematic review and practice management guideline from the Eastern Association for the Surgery of Trauma
No full textBACKGROUND: In addition to their convenience, ridesharing applications (apps) have the potential to offer a safer transportation alternative, especially in situations involving intoxication. Their use may lead to reductions in crash-related injuries and deaths, particularly due to alcohol-impaired driving. Several observational studies have aimed to assess the impact of ridesharing on alcohol-impaired driving, crashes, and deaths. Our goal was to systematically review the literature to inform policy makers and public health practitioners on the use of ridesharing apps in the reduction of crash injuries and deaths. METHODS: We performed an evidence-based systematic review using the Grading of Recommendations Assessment, Development, and Evaluation methodology to answer the following population, intervention, comparator, outcomes questions: (1) For the general population, should the presence of ridesharing services compared with no ridesharing be recommended for reducing motor vehicle crash (MVC)-related harms? (2) In the general population, should more versus less use of ridesharing services be recommended for reducing MVC-related harm? Our project was registered with the PROSPERO registry of systematic reviews and meta-analyses (CRD42023407489). We searched literature published from January 1, 2009 (first ridesharing app available), through December 31, 2022, using PubMed, web of science, and Scopus. RESULTS: Fifteen studies met the criteria for inclusion, covering a variety of geographies, populations, and methodological approaches. All evidence was observational, and overall quality of evidence was low. However, most studies (N = 11) showed benefit of ridesharing services for specific outcomes, with only one study indicating harm (increased total MVCs). CONCLUSION: Based on the available evidence, ridesharing may have a valuable role to play in reducing MVC-related harm. Public policy should consider ridesharing apps in the broader scheme of efforts to reduce driving-related morbidity and mortality. LEVEL OF EVIDENCE: Systematic Review; Level III
Reducing the Morbidity Associated With Incorrect Pediatric Tracheostomy Tube Placement: A Quality Improvement Initiative
No full textINTRODUCTION: Despite an increase in pediatric patients being discharged with a tracheostomy tube (TT), morbidity and mortality rates remain considerable. The aim of this quality improvement (QI) project is to reduce the proportion of tracheostomy documentation errors per 1000 tracheostomy patients by 50% or more, and sustain this for six months. METHODS: Using the Model for Improvement and a Plan-Do-Study-Act (PDSA) cycle, a key driver diagram (KDD) identified challenges in accessing accurate TT information within the electronic medical record (EMR). EMR representatives created an alert for any patient with a TT diagnosis code to provide immediate access to tracheostomy information. Assessment of this intervention was conducted using descriptive statistics and QI control charts. RESULTS: Prior to intervention, an average of 56 different tracheostomy patients per year were evaluated, and 15 events were recorded. Upon implementation of the alert, there was one safety event in the 180-day pilot period. Since the initial PDSA cycle, there have been two TT documentation events, improving the average from one error in every 40 patients seen over a 28-month period to one error in every 137 patients seen over a 24-month period (and counting). CONCLUSION: Increased access to accurate TT information in the EMR demonstrated an increased interval between events. Future work includes routinely tracking events as a new metric to follow and implementing other interventions from the KDD for a multi-interventional approach to the global aim. We recommend that organizations implement this straightforward approach to dramatically reduce untoward outcomes with catastrophic potential
Perspectives on Obesity Management and the Use of Anti-Obesity Medicine from US Employees and Employers: Results from the OBSERVE Study
No full textPersonal health factors and direct and indirect costs of obesity affect employers and employees. This research aimed to understand perceptions of obesity management and anti-obesity medications (AOMs) among employers and employees. In 2022, people with obesity and employers completed cross-sectional surveys about perceptions of obesity and its management, including AOMs. Data were analyzed with descriptive statistics. Data from 461 employed people with obesity (EwO) and 51 employer representatives (ER) were analyzed. Both EwO and ER acknowledged the impact of obesity on future health problems (88.3%; 100.0%) and perceived obesity as a disease (60.5%; 80.4%) to varied degrees. Both groups perceived an incremental value in combining self-directed lifestyle changes and AOMs (57.5%; 66.7%) and perceived healthcare provider-guided lifestyle change alongside AOMs as the most effective approach for maintaining long-term weight reduction (56.4%; 66.6%). More than two-thirds (68.6%) of ER expressed willingness to revisit their AOM coverage decisions, though cost of medication coverage (72.5%) and affordability of medications for employees (68.7%) were identified as barriers. ER believed that data showing reductions in premiums and claims at their organizations (78.4%) would be helpful in supporting the coverage of AOMs. While EwO and ER were receptive toward AOMs, organization-level barriers existed with AOM coverage. Evidence demonstrating the benefits of evidence-based obesity care, direct/indirect cost reductions, and the impact of obesity may address barriers to AOM coverage and improve obesity care and outcomes of their workforces
The evolution of teaching and learning regional anesthesia at every career stage: The U.S. perspective
No full textRegional anesthesia and analgesia are integral to modern perioperative medicine and contribute to multimodal analgesia and enhanced recovery protocols. Over the past two decades, regional anesthesia practice has changed dramatically with the incorporation of real-time ultrasound guidance. Anesthesiologists in the U.S. who completed residency training in the early 2000s were not routinely taught how to use ultrasound for regional anesthesia, and subspecialty fellowships in regional anesthesia at that time were relatively few and varied widely in terms of educational experience. Today, the state of regional anesthesia education in the U.S. is completely different and has embraced a multipronged, multigenerational approach that addresses the needs of anesthesiologists in training, as well as anesthesiologists in practice throughout the career lifecycle. This review will cover the current state of regional anesthesia education for residents, fellows, and practicing anesthesiologists and will note important historical advances, as well as future trends that may shape the curricula for regional anesthesia learners in formal training and continuing education
Six-Week Problem Area-Concordant vs 8-Week Problem Area-Discordant Group Interpersonal Psychotherapy: A Randomized Clinical Trial
No full textIMPORTANCE: Depression is a prevalent mental health condition contributing to morbidity worldwide. The World Health Organization (WHO) recommends group-based interpersonal psychotherapy (IPT-G) for first-line depression treatment in resource-constrained settings. Standard of care in the study context is 8 to 12 weekly sessions in groups with a mix of depression problem areas (eg, grief, life changes, loneliness, conflict). OBJECTIVE: To investigate whether grouping participants with a common depression problem area (problem area-concordant) using shortened IPT-G (6 sessions) is noninferior to grouping participants with a mix of problem areas (problem area-discordant) using standard IPT-G (8 sessions) in Uganda. DESIGN, SETTING, AND PARTICIPANTS: This noninferiority randomized clinical trial included adults 18 years or older in central Uganda with 9-item Patient Health Questionnaire (PHQ-9) scores of 10 or greater, indicating symptoms consistent with probable depression. Assessors were masked to treatment arm. Data were accrued from October 31, 2022, to March 24, 2023. INTERVENTIONS: Participants were randomized 1:1 to 6-session problem area-concordant or 8-session problem area-discordant IPT-G. MAIN OUTCOME AND MEASURES: The primary outcome was PHQ-9 score reduction at 3 months. Secondary outcomes were treatment response (PHQ-9 5-point, 10-point, and 50% score reduction), reduction in disability (WHO Disability Assessment Schedule 2.0), and improvement in subjective quality of life (WHO Quality of Life tool). RESULTS: Among 328 enrolled participants (303 [92.4%] female; mean [SD] age, 42.3 [15.2] years), retention was high, with 321 [97.9%] undergoing assessment at the end of therapy and 292 [89.0%] at 3-month follow-up. From baseline to the end of therapy, PHQ-9 scores dropped a mean (SD) of 15.2 (5.1) points in the problem area-concordant arm and 13.3 (5.3) points in the problem area-discordant arm. Problem area-concordant 6-week IPT-G was noninferior (P \u3c .001) at end of therapy and 3 months post therapy. Compared with the 8-week problem area-discordant arm, posttherapy PHQ-9 scores in the 6-week problem area-concordant arm were 1.86 (95% CI, 0.74-3.00) points lower (P = .001). At 3 months, PHQ-9 scores were 1.98 (95% CI, 0.60-3.36) points lower (P = .005). Disability score reduction was significantly larger post therapy in the 6-week arm compared with the 8-week arm (2.70 [95% CI, 0.95-4.44] points) but not significantly different between arms after 3 months. Quality of life scores across all domains were not significantly different between arms at end of therapy and 3 months post therapy. CONCLUSIONS AND RELEVANCE: In this randomized clinical trial, 6-week problem area-concordant IPT-G was noninferior to 8-week problem area-discordant IPT-G for reducing depression symptoms, with similar to larger improvements in disability and quality of life. Problem area-concordant group therapy appears to be a promising approach to increase efficiency and scalability of depression treatment. TRIAL REGISTRATION: Pan African Clinical Trials Registry Identifier: PACTR202306771120632
Preferences for Communication About Prognosis Among Children With Cancer, Parents, and Oncologists
No full textIMPORTANCE: Pediatric oncologists infrequently ask patients and parents about their preferences for receiving information about prognosis prior to initiating difficult conversations. The willingness of patients, parents, and oncologists to engage in discussions about prognostic disclosure preferences and their perceptions of best practices in these discussions remain understudied. OBJECTIVE: To explore and characterize recommendations from patients with pediatric cancer, as well as parents and oncologists, for if or how oncologists should elicit communication preferences regarding prognosis in advanced pediatric cancer. DESIGN, SETTING, AND PARTICIPANTS: This qualitative study used responses from patients with pediatric cancer, parents, and oncologists in single interviews conducted between 2022 and 2023. Eligible patients were aged 12 years or older and recruited from an academic pediatric cancer center and 5 affiliated referring centers across 5 states. Interviews were conducted at different time points in the advancing illness course. A framework for patient-clinician communication domains was used to organize interviews and summarize data, with rapid analysis conducted to generate themes. EXPOSURES: Poor prognosis pediatric cancer at different time points across the illness course: diagnosis, relapse or disease progression, phase 1 or 2 trial enrollment, and bereavement. MAIN OUTCOMES AND MEASURE: Identification of themes regarding patient, parent, and oncologist preferences for eliciting and disclosing prognostic information. RESULTS: The 85 participants surveyed included 25 patients (13 patients aged 12-14 years [52%]; 14 male [56%]; 6 Black [30%], 18 White [65%]), 40 parents (32 female [80%]; 14 Black [35%], 24 White [60%]), and 20 oncologists (14 female [70%]; 6 Asian [30%], 13 White [65%]), nearly all wanted to receive prognostic disclosure. Some patients, most parents, and most oncologists advocated for prognostic disclosure even if not requested or desired by patients or their parents, with 2 themes driving this recommendation: placing trust in medical experts and needing to stay informed. Most patients and parents, and some oncologists, emphasized the benefits of eliciting communication preferences before disclosing prognosis, generating 2 main themes: the value of individualized information and protecting mental and emotional well-being of patients and parents. Participants recommended targeted strategies to elicit prognostic communication preferences guided by 3 themes: ask questions, give options, and consider delivery or tone. CONCLUSIONS AND RELEVANCE: In this qualitative study of prognostic communication preferences, patients, parents, and oncologists recommended eliciting patient and parent preferences for prognostic disclosure in advance and provided advice for achieving this goal. Future work will integrate these recommendations in the development of targeted interventions to support individualized prognostic disclosure in advanced pediatric cancer