Effects of the FDA Codeine Safety Investigation on Racial and Geographic Disparities in Opioid Prescribing after Pediatric Tonsillectomy and/or Adenoidectomy.
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ABSTRACT:
SUBMITTER: Lawrence A
PROVIDER: S-EPMC7812397 | biostudies-literature | 2021
REPOSITORIES: biostudies-literature
Publications
Effects of the FDA Codeine Safety Investigation on Racial and Geographic Disparities in Opioid Prescribing after Pediatric Tonsillectomy and/or Adenoidectomy.
Lawrence Amy A Cooper Jennifer N JN Deans Katherine J KJ Minneci Peter C PC Wrona Sharon K SK Chisolm Deena J DJ
Global pediatric health 20210115
<i>Objective.</i> Our objective was to examine the impact of the U.S. FDA's 2013 black box warning against codeine on codeine and other opioid prescription filling after pediatric tonsillectomy and/or adenoidectomy (T/A) overall and by child race and provider urbanity/rurality. <i>Methods.</i> Patients ≤ 18 who underwent T/A in 8/2011 to 8/2016 were identified in Ohio Medicaid claims. Interrupted time series analyses were used to evaluate the impact of the FDA warning on codeine or other opioid ...[more]
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Project description:Geographic variation of paediatric tonsillectomy, with or without adenoidectomy, (A/T) has been described since the 1930s until today but no studies have investigated the factors associated with this variation. This study described the geographical distribution of paediatric A/T across the state of Victoria, Australia, and investigated area-level factors associated with this variation. We used linked administrative datasets capturing all paediatric A/T performed between 2010 and 2015 in Victoria. Surgery data were collapsed by patient residence to the level of Local Government Area. Regression models were used to investigate the association between likelihood of surgery and area-level factors. We found a 10.2-fold difference in A/T rates across the state, with areas of higher rates more in regional than metropolitan areas. Area-level factors associated with geographic variation of A/T were percentage of children aged 5-9 years (IRR 1.07, 95%CI 1.01-1.14, P = 0.03) and low English language proficiency (IRR 0.95, 95% CI 0.90-0.99, P = 0.03). In a sub-population analysis of surgeries in the public sector, these factors were low maternal educational attainment (IRR 1.09, 95% CI 1.02-1.16, P < 0.001) and surgical waiting time (IRR 0.99635 95% CI 0.99273-0.99997, P = 0.048). Identifying areas of focus for improvement and factors associated with geographic variation will assist in improving equitable provision of paediatric A/T and decrease variability within regions.
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Project description:IntroductionHepatocellular carcinoma disproportionately affects minorities. Southern states have high proportions of black populations and prevalence of known risk factors. Further research is needed to understand the role of southern geography in hepatocellular carcinoma disparities. This paper examined racial disparities in hepatocellular carcinoma incidence, demographics, tumor characteristics, receipt of treatment, and all-cause mortality in southern and non-southern cancer registries.MethodsSurveillance Epidemiology and End Results data were probed in 2015 to identify 43,868 patients diagnosed with hepatocellular carcinoma from 2000 to 2012 (5,455 in southern registries [Atlanta, Louisiana, and Rural and Greater Georgia]).ResultsSouthern registries showed steeper increases of age-adjusted hepatocellular carcinoma incidence (from 2.89 to 5.29cases/100,000 people) versus non-southern areas (from 3.58 to 5.54cases/100,000 people). Blacks were over-concentrated in southern registries (32% vs 10%). Compared with whites, blacks were significantly younger at diagnosis, more likely diagnosed with metastasis, and less likely to receive surgical therapies in both registry groups. After adjustment, blacks had a significantly higher risk of all-cause mortality compared with whites in southern (hazard ratio=1.10, p=0.007) and non-southern areas (hazard ratio=1.08, p<0.001). For overall populations, southern registries had higher risk of all-cause mortality versus non-southern registries (hazard ratio=1.13, p<0.001).ConclusionsAge-adjusted incidence rates of hepatocellular carcinoma are plateauing overall, but are still rising in southern areas. Race and geography had independent associations with all-cause mortality excess risk among patients with hepatocellular carcinoma. Further studies are needed to understand the root causes of potential mortality risk excess among overall populations with hepatocellular carcinoma living in the South.Supplement informationThis article is part of a supplement entitled African American Men's Health: Research, Practice, and Policy Implications, which is sponsored by the National Institutes of Health.
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Project description:ObjectiveTo measure the effects of race/ethnicity, area measures of socioeconomic status (SES) and geographic residency status, and health care supply (HCS) characteristics on breast cancer (BC)-related outcomes.Data sources/study settingFemale patients in Georgia diagnosed with BC in the years 2000-2009.Study designMultilevel regression analysis with adjustment for variables at the county, census tract (CT), and individual level. The county represents the spatial unit of analysis for HCS. SES and geographic residency status were grouped at the CT level.Principal findingsEven after controlling for area-level characteristics, racial and ethnic minority women suffered an unequal BC burden. Despite inferior outcomes for disease stage and receipt of treatment, Hispanics had a marginally significant decreased risk of death compared with non-Hispanics. Higher CT poverty was associated with worse BC-related outcomes. Residing in small, isolated rural areas increased the odds of receiving surgery, decreased the odds of receiving radiotherapy, and decreased the risk of death. A higher per-capita availability of BC care physicians was significantly associated with decreased risk of death.ConclusionsRace/ethnicity and area-level measures of SES, geographic residency status, and HCS contribute to disparities in BC-related outcomes.
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Project description:African Americans (AAs) have a higher incidence of multiple myeloma (MM) than White patients. Mortality is also higher in AAs compared with White patients. AAs more commonly have immunoglobulin H translocations t(11;14) and t(14;16) compared with White patients. We sought to characterize the demographic representation in MM clinical trials and evaluate outcomes based on race and ethnicity. We conducted a pooled analysis of all trials submitted to the US Food and Drug Administration (FDA) to support approval of a MM therapeutic between 2006 and 2019. Demographic characteristics were analyzed descriptively. An age-adjusted stratified Cox regression model was used to evaluate the relationship between time-to-event outcomes and race and ethnicity. Nineteen global trials comprising 10 157 patients were pooled. White, Asian, and Black patients comprised 84%, 7%, and 4% of the dataset, respectively; Hispanic patients comprised 4%. The age-adjusted overall survival hazard ratio (HR) for Black compared with White patients was 0.89 (95% confidence interval [CI], 0.75-1.05). The age-adjusted HR for US Black vs US White patients was 0.82 (95% CI, 0.66-1.02). For rest-of-world (RoW) Black vs RoW White patients, the HR was 1.31 (95% CI, 0.97-1.77). Black and Hispanic patients were underrepresented in the trials supporting FDA approval of MM drugs. Black patients were primarily enrolled in the United States. Outcomes in US patients were more favorable compared with those in patients in the RoW. Given the higher incidence of MM in AAs and the different disease characteristics, efforts should be made to improve representation of AAs in MM clinical trials.
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Project description:ImportanceIn prior studies, decreasing the default number of doses in opioid prescriptions written in electronic health record systems reduced opioid prescribing. However, these studies did not rigorously assess patient-reported outcomes, and few included pediatric patients.ObjectiveTo evaluate the association between decreasing the default number of doses in opioid prescriptions written in electronic health record systems and opioid prescribing and patient-reported outcomes among adolescents and young adults undergoing tonsillectomy.Design, setting, and participantsThis nonrandomized clinical trial included adolescents and young adults aged 12 to 50 years undergoing tonsillectomy from October 1, 2019, through July 31, 2021, at a tertiary medical center. The treatment group comprised patients from a pediatric otolaryngology service (mostly aged 12-21 years) and the control group comprised patients from a general otolaryngology service (mostly aged 18-25 years).InterventionsData on patient-reported opioid consumption and outcomes were collected via a survey on postoperative day 14. Based on opioid consumption among pediatric otolaryngology patients before the intervention, the default number of opioid doses was decreased from 30 to 12 in a tonsillectomy order set. This change occurred only for pediatric otolaryngology patients.Main outcomes and measuresProportion of patients with 12 doses in the discharge opioid prescription, number of doses in this prescription, and refills and pain-related visits within 2 weeks of surgery. In a secondary analysis of patients completing the postoperative survey, patient-reported opioid consumption, pain control, sleep disturbance, anxiety, and depression were assessed. Linear or log-linear difference-in-differences models were fitted, adjusting for patients' demographic characteristics and presence of a mental health or substance use disorder.ResultsThe study included 237 patients (147 female patients [62.0%]; mean [SD] age, 17.3 [3.6] years). Among 131 pediatric otolaryngology patients, 1 of 70 (1.4%) in the preintervention period and 27 of 61 (44.3%) in the postintervention period had 12 doses in the discharge opioid prescription (differential change, 45.5 percentage points; 95% CI, 32.2-58.8 percentage points). Among pediatric otolaryngology patients, the mean (SD) number of doses prescribed in the preintervention period was 22.3 (7.4) and in the postintervention period was 16.1 (6.5) (differential percentage change, -29.2%; 95% CI, -43.2% to -11.7%). The intervention was not associated with changes in refills or pain-related visits. The secondary analysis included 150 patients. The intervention was not associated with changes in patient-reported outcomes except for a 3.5-point (95% CI, 1.5-5.5 points) differential increase in a sleep disturbance score that ranged from 4 to 20, with higher scores indicating poorer sleep quality.Conclusions and relevanceThis nonrandomized clinical trial suggests that evidence-based default dosing settings may decrease perioperative opioid prescribing among adolescents and young adults undergoing tonsillectomy, without compromising analgesia.Trial registrationClinicalTrials.gov Identifier: NCT04066829.
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Project description:ObjectiveTo examine county-level geographic variation in treatment admissions among opioid treatment programs (OTPs) that accept Medicaid in the continental United States.Data sources/study settingData come from the 2012 National Survey of Substance Abuse Treatment Services.Study design/data collectionWe used local measures of spatial autocorrelation (LISA) analysis to identify (1) clusters of counties with higher and lower than average rates of opioid use disorders and (2) clusters of counties with higher and lower than average treatment admissions among OTPs that accept Medicaid, adjusting for county population size.Principal findingsOur results reveal several clusters of counties with higher than average rates of opioid use disorder (OUD) and lower than average treatment admissions among OTPs that accept Medicaid. These clusters are highly concentrated in the Southeast region of the country and include Arkansas, Kentucky, Louisiana, Mississippi, and Tennessee.ConclusionsMedicaid enrollees in areas in the Southeast have the largest gaps between county-level OUD rates and estimated county-level capacity for treatment, as measured by county-level total treatment admissions among OTPs that accept Medicaid. Policy makers should consider strategies to increase the availability of OTPs with the capacity to serve Medicaid enrollees.
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Project description:ObjectiveTo evaluate the race-stratified state-level prevalence of health determinants and the racial disparities in coronavirus disease 2019 (COVID-19) cumulative incidence and mortality in the United States.Patients and methodsThe age-adjusted race-stratified prevalence of comorbidities (hypertension, diabetes, dyslipidemia, and obesity), preexisting medical conditions (pulmonary disease, heart disease, stroke, kidney disease, and malignant neoplasm), poor health behaviors (smoking, alcohol abuse, and physical inactivity), and adverse socioeconomic factors (education, household income, and health insurance) was computed in 435,139 American adult participants from the 2017 Behavioral Risk Factor Surveillance System survey. Correlation was assessed between health determinants and the race-stratified COVID-19 crude mortality rate and infection-fatality ratio computed from respective state public health departments in 47 states.ResultsBlacks had a higher prevalence of comorbidities (63.3%; 95% CI, 62.4% to 64.2% vs 55.1%; 95% CI, 54.7% to 55.5%) and adverse socioeconomic factors (47.0%; 95% CI, 46.0% to 47.9% vs 30.9%; 95% CI, 30.6% to 31.3%) than did whites. The prevalence of preexisting medical conditions was similar in blacks (30.4%; 95% CI, 28.8% to 32.1%) and whites (30.8%; 95% CI, 30.2% to 31.4%). The prevalence of poor health behaviors was higher in whites (57.2%; 95% CI, 56.3% to 58.0%) than in blacks (50.2%; 95% CI,46.2% to 54.2%). Comorbidities and adverse socioeconomic factors were highest in the southern region, and poor health behaviors were highest in the western region. The cumulative incidence rate (per 100,000 persons) was 3-fold higher in blacks (1546.4) than in whites (540.4). The crude mortality rate (per 100,000 persons) was 2-fold higher in blacks (83.2) than in whites (33.2). However, the infection-fatality ratio (per 100 cases) was similar in whites (6.2) and blacks (5.4). Within racial groups, the geographic distribution of health determinants did not correlate with the state-level COVID-19 mortality and infection-fatality ratio (P>.05 for all).ConclusionRacial disparities in COVID-19 are largely driven by the higher cumulative incidence of infection in blacks. There is a discordance between the geographic dispersion of COVID-19 mortality and the regional distribution of health determinants.
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Project description:ImportanceBlood type (BT) O has been identified as a risk factor for bleeding complications, while non-O BTs may increase risk for thromboembolic events. Limited data are available in children undergoing tonsillectomy with or without adenoidectomy.ObjectiveTo determine whether BT O is associated with hemorrhage after tonsillectomy with or without adenoidectomy.Design, setting, and participantsRetrospective cohort study of patients younger than 22 years who underwent tonsillectomy with or without adenoidectomy at a single institution between January 1, 2008, and August 7, 2017. Statistical analysis was performed from November 2017 to January 2019.Main outcomes and measuresPrevalence of hemorrhage following surgery was defined as any bleeding requiring cauterization up to 1 month after the procedure. Data on sex, age, von Willebrand disease (VWD) status, BT, white blood cell counts, and platelet counts closest to date of surgery were collected from an electronic medical record system, and the association of these factors with hemorrhage following surgery was investigated.ResultsA total of 14 951 pediatric patients (median [range] age, 5.6 [0.8-21.9] years; 6956 [46.5%] female) underwent tonsillectomy with or without adenoidectomy. Prevalence of hemorrhage following the procedure was 3.9% (578 patients) for the full cohort and 2.8% (362 of 13 065) for patients with no BT identified or preprocedure VWD panel results at baseline. Children who had a BT identified and/or a VWD panel before surgery had higher bleeding rates (BT only, 14.9% [172 of 1156]; preprocedure VWD panel only, 4.6% [28 of 607]; and BT and preprocedure VWD panel, 13.0% [16 of 123]), all of which were significantly different from the baseline bleeding rate (P < .001). While the bleeding rates in children with BT O were not statistically different from those with non-O BT (14.8% and 14.6%, respectively; P > .99), mean von Willebrand factor values were statistically different (mean [SD] von Willebrand factor antigen level in O group, 86.9 [42.4] IU/dL in the O group vs 118.0 [53.8] IU/dL in the non-O group; P = .002; and mean [SD] von Willebrand factor ristocetin-cofactor in the O group, 72.2 [44.3] IU/dL vs 112.6 [68.0] IU/dL in the non-O group; P = .001). In addition, children older than 12 years had increased bleeding rates in the full cohort (8.3% vs 3.2%), in the testing-naive cohort (6.5% vs 2.3%), and in those with a preprocedure VWD panel only (13.5% vs 3.1%) compared with children aged 12 years or younger.Conclusions and relevanceType O blood was not a risk factor associated with hemorrhage after tonsillectomy with or without adenoidectomy despite lower baseline von Willebrand factor antigen and von Willebrand factor ristocetin-cofactor values in children with BT O vs those with non-O BT in our study cohort. No association was found between VWD status and bleeding, and there was no difference in VWD panel values in those who experienced hemorrhage vs those who did not within BT groups. Further studies elucidating the utility of von Willebrand factor values for children undergoing tonsillectomy with or without adenoidectomy are needed.
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