JAMA. 2023 Jan 23. doi: 10.1001/jama.2022.25080. Online ahead of print.
NO ABSTRACT
PMID:36689237 | DOI:10.1001/jama.2022.25080
Category: Nevin Manimala
JAMA Netw Open. 2023 Jan 3;6(1):e2251182. doi: 10.1001/jamanetworkopen.2022.51182.
ABSTRACT
IMPORTANCE: While research has identified racial and ethnic disparities in access to autism services, the size, extent, and specific locations of these access gaps have not yet been characterized on a national scale. Mapping comprehensive national listings of autism health care services together with the prevalence of autistic children of various races and ethnicities and evaluating geographic regions defined by localized commuting patterns may help to identify areas within the US where families who belong to minoritized racial and ethnic groups have disproportionally lower access to services.
OBJECTIVE: To evaluate differences in access to autism health care services among autistic children of various races and ethnicities within precisely defined geographic regions encompassing all serviceable areas within the US.
DESIGN, SETTING, AND PARTICIPANTS: This population-based cross-sectional study was conducted from October 5, 2021, to June 3, 2022, and involved 530 965 autistic children in kindergarten through grade 12. Core-based statistical areas (CBSAs; defined as areas containing a city and its surrounding commuter region), the Civil Rights Data Collection (CRDC) data set, and 51 071 autism resources (collected from October 1, 2015, to December 18, 2022) geographically distributed into 912 CBSAs were combined and analyzed to understand variation in access to autism health care services among autistic children of different races and ethnicities. Six racial and ethnic categories (American Indian or Alaska Native, Asian, Black or African American, Hispanic or Latino, Native Hawaiian or other Pacific Islander, and White) assigned by the US Department of Education were included in the analysis.
MAIN OUTCOMES AND MEASURES: A regularized least-squares regression analysis was used to measure differences in nationwide resource allocation between racial and ethnic groups. The number of autism resources allocated per autistic child was estimated based on the child’s racial and ethnic group. To evaluate how the CBSA population size may have altered the results, the least-squares regression analysis was run on CBSAs divided into metropolitan (>50 000 inhabitants) and micropolitan (10 000-50 000 inhabitants) groups. A Mann-Whitney U test was used to compare the model estimated ratio of autism resources to autistic children among specific racial and ethnic groups comprising the proportions of autistic children in each CBSA.
RESULTS: Among 530 965 autistic children aged 5 to 18 years, 83.9% were male and 16.1% were female; 0.7% of children were American Indian or Alaska Native, 5.9% were Asian, 14.3% were Black or African American, 22.9% were Hispanic or Latino, 0.2% were Native Hawaiian or other Pacific Islander, 51.7% were White, and 4.2% were of 2 or more races and/or ethnicities. At a national scale, American Indian or Alaska Native autistic children (β = 0; 95% CI, 0-0; P = .01) and Hispanic autistic children (β = 0.02; 95% CI, 0-0.06; P = .02) had significant disparities in access to autism resources in comparison with White autistic children. When evaluating the proportion of autistic children in each racial and ethnic group, areas in which Black autistic children (>50% of the population: β = 0.05; <50% of the population: β = 0.07; P = .002) or Hispanic autistic children (>50% of the population: β = 0.04; <50% of the population: β = 0.07; P < .001) comprised greater than 50% of the total population of autistic children had significantly fewer resources than areas in which Black or Hispanic autistic children comprised less than 50% of the total population. Comparing metropolitan vs micropolitan CBSAs revealed that in micropolitan CBSAs, Black autistic children (β = 0; 95% CI, 0-0; P < .001) and Hispanic autistic children (β = 0; 95% CI, 0-0.02; P < .001) had the greatest disparities in access to autism resources compared with White autistic children. In metropolitan CBSAs, American Indian or Alaska Native autistic children (β = 0; 95% CI, 0-0; P = .005) and Hispanic autistic children (β = 0.01; 95% CI, 0-0.06; P = .02) had the greatest disparities compared with White autistic children.
CONCLUSIONS AND RELEVANCE: In this study, autistic children from several minoritized racial and ethnic groups, including Black and Hispanic autistic children, had access to significantly fewer autism resources than White autistic children in the US. This study pinpointed the specific geographic regions with the greatest disparities, where increases in the number and types of treatment options are warranted. These findings suggest that a prioritized response strategy to address these racial and ethnic disparities is needed.
PMID:36689227 | DOI:10.1001/jamanetworkopen.2022.51182
JAMA Netw Open. 2023 Jan 3;6(1):e2251974. doi: 10.1001/jamanetworkopen.2022.51974.
ABSTRACT
IMPORTANCE: The COVID-19 pandemic has caused millions of infections and deaths and resulted in unprecedented international public health social and economic crises. As SARS-CoV-2 spread across the globe and its impact became evident, the development of safe and effective vaccines became a priority. Outlining the processes used to establish and support the conduct of the phase 3 randomized clinical trials that led to the rapid emergency use authorization and approval of several COVID-19 vaccines is of major significance for current and future pandemic response efforts.
OBSERVATIONS: To support the rapid development of vaccines for the US population and the rest of the world, the National Institute of Allergy and Infectious Diseases established the COVID-19 Prevention Network (CoVPN) to assist in the coordination and implementation of phase 3 efficacy trials for COVID-19 vaccine candidates and monoclonal antibodies. By bringing together multiple networks, CoVPN was able to draw on existing clinical and laboratory infrastructure, community partnerships, and research expertise to quickly pivot clinical trial sites to conduct COVID-19 vaccine trials as soon as the investigational products were ready for phase 3 testing. The mission of CoVPN was to operationalize phase 3 vaccine trials using harmonized protocols, laboratory assays, and a single data and safety monitoring board to oversee the various studies. These trials, while staggered in time of initiation, overlapped in time and course of conduct and ultimately led to the successful completion of multiple studies and US Food and Drug Administration-licensed or -authorized vaccines, the first of which was available to the public less than 1 year from the discovery of the virus.
CONCLUSIONS AND RELEVANCE: This Special Communication describes the design, geographic distribution, and underlying principles of conduct of these efficacy trials and summarizes data from 136 382 prospectively followed-up participants, including more than 2500 with documented COVID-19. These successful efforts can be replicated for other important research initiatives and point to the importance of investments in clinical trial infrastructure integral to pandemic preparedness.
PMID:36689221 | DOI:10.1001/jamanetworkopen.2022.51974
Phys Eng Sci Med. 2023 Jan 23. doi: 10.1007/s13246-023-01219-6. Online ahead of print.
ABSTRACT
Recent technological advances have allowed the possibility of performing patient-specific quality assurance (QA) without time-intensive measurements. The objectives of this study are to: (1) compare how well the log file-based Mobius QA system agrees with measurement-based QA methods (ArcCHECK and portal dosimetry, PD) in passing and failing plans, and; (2) evaluate their error sensitivities. To these ends, ten phantom plans and 100 patient plans were measured with ArcCHECK and PD on VitalBeam, while log files were sent to Mobius for dose recalculation. Gamma evaluation was performed using criteria 3%/2 mm, per TG218 recommendations, and non-inferiority of the Mobius recalculation was determined with statistical testing. Ten random plans were edited to include systematic errors, then subjected to QA. Receiver operating characteristic curves were constructed to compare error sensitivities across the QA systems, and clinical significance of the errors was determined by recalculating dose to patients. We found no significant difference between Mobius, ArcCHECK, and PD in passing plans at the TG218 action limit. Mobius showed good sensitivity to collimator and gantry errors but not MLC bank shift errors, but could flag discrepancies in treatment delivery. Systematic errors were clinically significant only at large magnitudes; such unacceptable plans did not pass QA checks at the TG218 tolerance limit. Our results show that Mobius is not inferior to existing measurement-based QA systems, and can supplement existing QA practice by detecting real-time delivery discrepancies. However, it is still important to maintain rigorous routine machine QA to ensure reliability of machine log files.
PMID:36689188 | DOI:10.1007/s13246-023-01219-6
J Gastrointest Surg. 2023 Jan 23. doi: 10.1007/s11605-022-05575-8. Online ahead of print.
ABSTRACT
BACKGROUND: The complexity of the upper gastrointestinal (UGI) multidisciplinary team (MDT) is continually growing, leading to rising clinician workload, time pressures, and demands. This increases heterogeneity or ‘noise’ within decision-making for patients with oesophageal cancer (OC) and may lead to inconsistent treatment decisions. In recent decades, the application of artificial intelligence (AI) and more specifically the branch of machine learning (ML) has led to a paradigm shift in the perceived utility of statistical modelling within healthcare. Within oesophageal cancer (OC) care, ML techniques have already been applied with early success to the analyses of histological samples and radiology imaging; however, it has not yet been applied to the MDT itself where such models are likely to benefit from incorporating information-rich, diverse datasets to increase predictive model accuracy.
METHODS: This review discusses the current role the MDT plays in modern UGI cancer care as well as the utilisation of ML techniques to date using histological and radiological data to predict treatment response, prognostication, nodal disease evaluation, and even resectability within OC.
RESULTS: The review finds that an emerging body of evidence is growing in support of ML tools within multiple domains relevant to decision-making within OC including automated histological analysis and radiomics. However, to date, no specific application has been directed to the MDT itself which routinely assimilates this information.
CONCLUSIONS: The authors feel the UGI MDT offers an information-rich, diverse array of data from which ML offers the potential to standardise, automate, and produce more consistent, data-driven MDT decisions.
PMID:36689150 | DOI:10.1007/s11605-022-05575-8
Drug Saf. 2023 Jan 23. doi: 10.1007/s40264-022-01269-x. Online ahead of print.
ABSTRACT
INTRODUCTION: Deliberate self-poisoning (DSP) using drugs is the preferred method of suicide at a global level. Its investigation is hampered by limited sample sizes and data reliability. We investigate the role of the US FDA Adverse Event Reporting System (FAERS), a consolidated pharmacovigilance database, in outlining DSP habits and toxidromes.
METHODS: We retrieved cases of ‘intentional overdose’ and ‘poisoning deliberate’ from the FAERS (January 2004-December 2021). Using descriptive and disproportionality analyses, we estimated temporal trends, potential risk factors, toxidromes, case-fatality rates and lethal doses (LDs) for the most frequently reported drugs.
RESULTS: We retrieved 42,103 DSP cases (17% fatal). Most cases were submitted in winter. Reports of DSP involved younger people, psychiatric conditions, and alcohol use, compared with non-DSP, and fatality was higher in men and older patients. Suspected drugs were mainly antidepressants, analgesics, and antipsychotics. Multiple drug intake was recorded in more than 50% of the reports, especially analgesics, psychotropics, and cardiovascular agents. The most frequently reported drugs were paracetamol, promethazine, amlodipine, quetiapine, and metformin. We estimated LD25 for paracetamol (150 g).
CONCLUSION: Worldwide coverage of the FAERS complements existing knowledge about DSP and may drive tailored prevention measures to timely address the DSP phenomenon and prevent intentional suicides.
PMID:36689131 | DOI:10.1007/s40264-022-01269-x
Can J Public Health. 2023 Jan 23. doi: 10.17269/s41997-022-00736-3. Online ahead of print.
ABSTRACT
OBJECTIVES: Canada’s ongoing drug poisoning crisis has contributed to unprecedented rates of morbidity and mortality. Health Canada has funded safer supply pilot programs to help connect people who use drugs to pharmaceutical grade medications that reduce their reliance on a toxic drug supply. However, most provinces, including Alberta and Saskatchewan, have not endorsed these initiatives. We explored public support for safer supply programs in these two Canadian provinces and identified predictors of support for this policy option.
METHODS: Cross-sectional data were examined from an online panel survey that included measures assessing views on policy responses to substance use and addiction. A total of 1602 adults were recruited during March 2021. We used descriptive statistics to characterize support for safer supply programs in Alberta and Saskatchewan and multinominal logistic regression analysis to examine predictors of public support for safer supply.
RESULTS: The majority of respondents (AB: 63.5% and SK: 56.3%) supported safer supply programs that replace illegal street drugs with pharmaceutical alternatives for those unable to stop using. Predicted probabilities show a greater probability of support for safer supply among those with higher education and those leaning left on the political spectrum.
CONCLUSION: A majority of Canadians from Alberta and Saskatchewan supported provincial government efforts to expand safer supply, suggesting a lack of public support is not the main barrier to implementation. Efforts at mobilizing this public opinion are needed to scale up and facilitate evaluation of this drug poisoning response.
PMID:36689127 | DOI:10.17269/s41997-022-00736-3
Int Urol Nephrol. 2023 Jan 23. doi: 10.1007/s11255-023-03473-9. Online ahead of print.
ABSTRACT
PURPOSE: Little is known about the relationships between apathy, depressive symptoms and interdialytic weight gain (IDWG) in patients on chronic hemodialysis. Aim of the present study is to investigate the association between IDWG and symptoms of depression and apathy in hemodialysis patients.
METHODS: A total of 139 chronic patients of the HD units between January 2020 and December 2021 were included in the present cross-sectional study. IDWG was calculated as the difference between the pre-HD weight and the weight registered after the previous session; the average of the sessions in a month was registered. Apathy Evaluation Scale (AES) was adopted to evaluate apathy. Depression was assessed by Beck Depression Inventory (BDI).
RESULTS: Ninety-three patients had IDWG% ≤ 4 and 46 had an IDWG% > 4. Correlation between IDWG% and BDI as well that between IDWG% and AES were not statistically significant. Median BDI and mean AES did not differ significantly between the groups. In addition, 104 patients had a BDI < 16 and 35 had a BDI ≥ 6. Seventy-five patients had an AES score ≤ 35 and 63 had a AES score > 35. The IDWG (kg) and the IDWG% did not differ significantly between the two groups.
CONCLUSION: IDWG is not associated with symptoms of depression or apathy in hemodialysis patients. Thus, these results may question if the use of behavioral intervention aimed at improving motivation is warranted in the hemodialysis population to reduce the IDWG.
PMID:36689088 | DOI:10.1007/s11255-023-03473-9
Musculoskelet Surg. 2023 Jan 23. doi: 10.1007/s12306-023-00773-2. Online ahead of print.
ABSTRACT
There are still some controversies regarding the clinical use of cementless UKAs. The aim of this systematic review was to determine whether cementless medial UKA leads to similar outcomes compared to cemented medial UKA. This search was conducted in accordance with the Preferred Reporting Items for Systematic Reviews guidelines (PRISMA). The random effects model with 95% confidence interval (CI) was applied to the analysis. The I2 statistic was used to assess study heterogeneity. Six studies were eligible for inclusion (4784 UKAs, 4776 patients): 2947 cemented UKAs (61.6%) and 1837 cementless UKAs (38.4%). The overall mean follow-up was 4.9 years. The all-cause reoperation rate was 11.3% (80 of 706) at mean 5.7-year follow-up for cemented UKA and 6.9% (57 of 824) at mean 4.1-year follow-up for the cementless. The overall revision rate was 10.2% (303 of 2947) for the cemented and 5.8% (108 of 1837) for the cementless. Aseptic loosening was the most frequent reason of revision (2.3% cemented vs 0.5% cementless). The overall rate of radiolucent lines (RLL) was 28.3% (63 of 223) in the cemented cohort and 11.1% in the cementless (26 of 234). All the studies reported improved functional outcomes. Cementless UKA provides at least equivalent if not better results compared to cemented UKA. Despite the use of cemented UKA outnumber cementless fixation, available data shows that cementless UKA had a reduced midterm revision rate, while providing similar functional outcomes.
PMID:36689086 | DOI:10.1007/s12306-023-00773-2
Target Oncol. 2023 Jan 23. doi: 10.1007/s11523-022-00933-7. Online ahead of print.
ABSTRACT
BACKGROUND: Isocitrate dehydrogenase-1 (IDH1) mutations occur in a significant proportion of intrahepatic cholangiocarcinomas (iCCAs). No data are available regarding the prognostic impact of IDH1 mutations in advanced iCCA patients after progression on first-line therapies.
OBJECTIVE: We investigated the role of IDH1 mutation in advanced iCCA after progression on first-line therapies.
PATIENTS AND METHODS: After progression on first-line therapies for advanced iCCA, consecutive patients were retrospectively collected. The IDH1 status was tested at baseline. This analysis aimed to examine the association between the presence of IDH1 missense mutations and survival outcomes in patients with advanced iCCA treated with a second-line therapy.
RESULTS: The analysis included 119 patients; 56/119 (47%) were IDH1 mutated (IDH1m) and 63/119 (53%) were IDH1 wild type (IDH1 WT). At univariate analysis for overall survival (OS), the presence of IDH1 mutation was associated with a worse median OS (mOS; 8.2 vs. 14.1 months; hazard ratio [HR] 1.9, 95% confidence interval [CI] 1.2-3.0, p = 0.0047). Patients harboring IDH1 mutations showed a worse objective response rate (ORR) compared with patients without IDH1 mutation, whereas no significant differences in disease control rate (DCR) were found. Multivariate analysis confirmed IDH1 mutations as an independent negative prognostic factor for OS (HR 1.7, 95% CI 1.1-2.7, p = 0.0256). By evaluating only patients receiving FOLFOX as second-line therapy, no statistically significant differences were found in terms of both OS and PFS between IDH1m and IDH1 WT patients. In this subset of patients, those harboring an IDH1 mutation showed a worse ORR and DCR compared with those without. Finally, at univariate analysis for OS from third-line treatment, the presence of an IDH1 mutation was associated with a trend toward a worse mOS (6.0 vs. 11.9 months; HR 1.6, 95% CI 0.8-3.2, p = 0.25).
CONCLUSION: The present analysis constitutes the first evidence of a negative prognostic impact of IDH1 mutations in a cohort of patients treated after progression on first-line therapies in contrast to IDH1 inhibitors.
PMID:36689074 | DOI:10.1007/s11523-022-00933-7