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1.
Artigo em Inglês | MEDLINE | ID: mdl-32133717

RESUMO

OBJECTIVES: To introduce the methodology of the ALCAPONE project. BACKGROUND: The French National Healthcare System Database (SNDS), covering 99% of the French population, provides a potentially valuable opportunity for drug safety alert generation. ALCAPONE aimed to assess empirically in the SNDS case-based designs for alert generation related to four health outcomes of interest. METHODS: ALCAPONE used a reference set adapted from observational medical outcomes partnership (OMOP) and Exploring and Understanding Adverse Drug Reactions (EU-ADR) project, with four outcomes-acute liver injury (ALI), myocardial infarction (MI), acute kidney injury (AKI), and upper gastrointestinal bleeding (UGIB)-and positive and negative drug controls. ALCAPONE consisted of four main phases: (1) data preparation to fit the OMOP Common Data Model and select the drug controls; (2) detection of the selected controls via three case-based designs: case-population, case-control, and self-controlled case series, including design variants (varying risk window, adjustment strategy, etc.); (3) comparison of design variant performance (area under the ROC curve, mean square error, etc.); and (4) selection of the optimal design variants and their calibration for each outcome. RESULTS: Over 2009-2014, 5225 cases of ALI, 354 109 MI, 12 633 AKI, and 156 057 UGIB were identified using specific definitions. The number of detectable drugs ranged from 61 for MI to 25 for ALI. Design variants generated more than 50 000 points estimates. Results by outcome will be published in forthcoming papers. CONCLUSIONS: ALCAPONE has shown the interest of the empirical assessment of pharmacoepidemiological approaches for drug safety alert generation and may encourage other researchers to do the same in other databases.

2.
Ann Intern Med ; 2020 Mar 10.
Artigo em Inglês | MEDLINE | ID: mdl-32150751

RESUMO

Background: Apixaban and rivaroxaban are the most commonly prescribed direct oral anticoagulants for adults with atrial fibrillation, but head-to-head data comparing their safety and effectiveness are lacking. Objective: To compare the safety and effectiveness of apixaban versus rivaroxaban for patients with nonvalvular atrial fibrillation. Design: New-user, active-comparator, retrospective cohort study. Setting: A U.S. nationwide commercial health care claims database from 28 December 2012 to 1 January 2019. Patients: Adults newly prescribed apixaban (n = 59 172) or rivaroxaban (n = 40 706). Measurements: The primary effectiveness outcome was a composite of ischemic stroke or systemic embolism. The primary safety outcome was a composite of intracranial hemorrhage or gastrointestinal bleeding. Results: 39 351 patients newly prescribed apixaban were propensity score matched to 39 351 patients newly prescribed rivaroxaban. Mean age was 69 years, 40% of patients were women, and mean follow-up was 288 days for new apixaban users and 291 days for new rivaroxaban users. The incidence rate of ischemic stroke or systemic embolism was 6.6 per 1000 person-years for adults prescribed apixaban compared with 8.0 per 1000 person-years for those prescribed rivaroxaban (hazard ratio [HR], 0.82 [95% CI, 0.68 to 0.98]; rate difference, 1.4 fewer events per 1000 person-years [CI, 0.0 to 2.7]). Adults prescribed apixaban also had a lower rate of gastrointestinal bleeding or intracranial hemorrhage (12.9 per 1000 person-years) compared with those prescribed rivaroxaban (21.9 per 1000 person-years), corresponding to an HR of 0.58 (CI, 0.52 to 0.66) and a rate difference of 9.0 fewer events per 1000 person-years (CI, 6.9 to 11.1). Limitation: Unmeasured confounding, incomplete laboratory data. Conclusion: In routine care, adults with atrial fibrillation prescribed apixaban had a lower rate of both ischemic stroke or systemic embolism and bleeding compared with those prescribed rivaroxaban. Primary Funding Source: Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital.

3.
Drug Saf ; 2020 Mar 16.
Artigo em Inglês | MEDLINE | ID: mdl-32180134

RESUMO

INTRODUCTION: Clinical practice guidelines recommend co-prescribing naloxone to patients at high risk of opioid overdose, but few such patients receive naloxone. High costs of naloxone may contribute to limited dispensing. OBJECTIVE: The aim of this study was to evaluate rates and costs of dispensing naloxone to patients receiving opioid prescriptions and at high risk for opioid overdose. METHODS: Using claims data from a large US commercial insurance company, we conducted a retrospective cohort study of new opioid initiators between January 2014 and December 2018. We identified patients at high risk for overdose defined as a diagnosis of opioid use disorder, prior overdose, an opioid prescription of ≥ 50 mg morphine equivalents/day for ≥ 90 days, and/or concurrent benzodiazepine prescriptions. RESULTS: Among 5,292,098 new opioid initiators, 616,444 (12%) met criteria for high risk of overdose during follow-up, and, of those, 3096 (0.5%) were dispensed naloxone. The average copayment was US$24.83 for naloxone (standard deviation [SD] 67.66) versus US$9.74 for the index opioid (SD 19.75). The average deductible was US$6.18 for naloxone (SD 27.32) versus US$3.74 for the index opioid (SD 25.56), with 94% and 88% having deductibles of US$0 for their naloxone and opioid prescriptions, respectively. The average out-of-pocket cost was US$31.01 for naloxone (SD 73.64) versus US$13.48 for the index opioid (SD 34.95). CONCLUSIONS: Rates of dispensing naloxone to high risk patients were extremely low, and prescription costs varied greatly. Since improving naloxone's affordability may increase access, whether naloxone's high cost is associated with low dispensing rates should be evaluated.

4.
Value Health ; 23(2): 217-226, 2020 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-32113627

RESUMO

OBJECTIVES: Inappropriate use of the case-crossover design, which is efficient for examining associations between brief exposure and abrupt outcomes, in evaluating the effects of medications in the presence of exposure-time trends or persistent drug use may generate spurious associations. We compared different approaches to adjusting for these sources of bias by examining the risk of heart failure hospitalization (HFH) associated with dipeptidyl peptidase-4 (DPP-4) inhibitors. Overall, existing evidence does not suggest a higher risk of HFH associated with DPP-4 inhibitors; however, case-crossover analyses of these medications may be susceptible to bias. METHODS: We conducted case-crossover; age, sex, risk-set (ASR) matched case-time-control; disease risk score (DRS)-matched case-time-control; and case-case-time-control analyses to assess the association between DPP-4 inhibitors and HFH among patients with diabetes mellitus (DM) in a population-based Taiwanese database. We also examined metformin and sulfonylureas, both with assumed null associations. RESULTS: Among 362 022 DM patients, 4105 (case-crossover), 4103 (ASR-matched case-time-control), 3957 (DRS-matched case-time-control), and 2812 (case-case-time-control) HFH cases were identified. The OR for DPP-4 inhibitors and HFH was elevated in the case-crossover analysis (1.52; 95% confidence interval [95% CI] 0.95-2.42). The ASR-matched case-time control, DRS-matched case-time-control, and case-case-time control analyses yielded near-null associations (0.90 [95% CI 0.45-1.83], 0.96 [95% CI 0.46-2.02], and 0.92 [95% CI 0.39-2.21], respectively). Null effects were observed for metformin across designs and for sulfonylureas in the case-case-time control analysis. CONCLUSIONS: Our case-crossover analysis suggested DPP-4 inhibitors may be associated with HFH; however, each method for adjusting for exposure-time and persistent user bias attenuated the findings. The case-case-time-control analysis had the least precision.

5.
Cardiovasc Diabetol ; 19(1): 25, 2020 Feb 25.
Artigo em Inglês | MEDLINE | ID: mdl-32098624

RESUMO

BACKGROUND: The low cost of thiazolidinediones makes them a potentially valuable therapeutic option for the > 300 million economically disadvantaged persons worldwide with type 2 diabetes mellitus. Differential selectivity of thiazolidinediones for peroxisome proliferator-activated receptors in the myocardium may lead to disparate arrhythmogenic effects. We examined real-world effects of thiazolidinediones on outpatient-originating sudden cardiac arrest (SCA) and ventricular arrhythmia (VA). METHODS: We conducted population-based high-dimensional propensity score-matched cohort studies in five Medicaid programs (California, Florida, New York, Ohio, Pennsylvania | 1999-2012) and a commercial health insurance plan (Optum Clinformatics | 2000-2016). We defined exposure based on incident rosiglitazone or pioglitazone dispensings; the latter served as an active comparator. We controlled for confounding by matching exposure groups on propensity score, informed by baseline covariates identified via a data adaptive approach. We ascertained SCA/VA outcomes precipitating hospital presentation using a validated, diagnosis-based algorithm. We generated marginal hazard ratios (HRs) via Cox proportional hazards regression that accounted for clustering within matched pairs. We prespecified Medicaid and Optum findings as primary and secondary, respectively; the latter served as a conceptual replication dataset. RESULTS: The adjusted HR for SCA/VA among rosiglitazone (vs. pioglitazone) users was 0.91 (0.75-1.10) in Medicaid and 0.88 (0.61-1.28) in Optum. Among Medicaid but not Optum enrollees, we found treatment effect heterogeneity by sex (adjusted HRs = 0.71 [0.54-0.93] and 1.16 [0.89-1.52] in men and women respectively, interaction term p-value = 0.01). CONCLUSIONS: Rosiglitazone and pioglitazone appear to be associated with similar risks of SCA/VA.

7.
Artigo em Inglês | MEDLINE | ID: mdl-31972062

RESUMO

PURPOSE: When investigators have two claims-based definitions for a binary confounder, it is unclear whether to prefer the more sensitive or more specific definition. Our objective was to compare adjusting for the sensitive or specific definition alone vs two novel approaches combining both definitions: a "two-algorithm indicator" and a "two-algorithm restriction" approach. METHODS: Each simulated patient had a binary exposure, outcome, and confounder. We created two nested, misclassified versions of the confounder using validated heart failure definitions. The sensitive definition had a sensitivity/specificity of 0.98/0.83, while the specific definition had a sensitivity/specificity of 0.77/0.99. Patients were classified into 3 groups: group 0 did not meet either definition, group 1 met the sensitive but not specific definition, and group 2 met both. The two-algorithm indicator approach adjusted using indicators for groups 1 and 2, while the two-algorithm restriction approach excluded patients in group 1 and adjusted using an indicator for group 2. Adjusted exposure odds ratios (ORs) were estimated for each approach using logistic regression. RESULTS: The crude OR was 1.33 (95% CI, 1.07-1.63). Adjusting for the specific or sensitive definitions resulted in ORs of 1.09 (95% CI, 0.87-1.35) and 1.14 (95% CI, 0.91-1.40). The two-algorithm indicator method returned an OR of 1.07 (95% CI, 0.86-1.33). The two-algorithm restriction approach returned an OR of 1.02 (95% CI, 0.79-1.29) but excluded 20% of the cohort. CONCLUSIONS: The two-algorithm indicator approach may improve adjustment for claims-based confounders by returning a point estimate at least as unbiased as the better of the two component definitions.

10.
Stat Med ; 39(3): 340-351, 2020 Feb 10.
Artigo em Inglês | MEDLINE | ID: mdl-31769079

RESUMO

Sequential analysis is used in clinical trials and postmarket drug safety surveillance to prospectively monitor efficacy and safety to quickly detect benefits and problems, while taking the multiple testing of repeated analyses into account. When there are multiple outcomes, each one may be given a weight corresponding to its severity. This paper introduces an exact sequential analysis procedure for multiple weighted binomial end points; the analysis incorporates a drug's combined benefit and safety profile. It works with a variety of alpha spending functions for continuous, group, or mixed group-continuous sequential analysis. The binomial probabilities may vary over time and do not need to be known a priori. The new method was implemented in the free R Sequential package for both one- and two-tailed sequential analysis. An example is given examining myocardial infarction and major bleeding events in patients who initiated non-steroidal antiinflammatory drugs.

11.
Acta Obstet Gynecol Scand ; 99(3): 399-405, 2020 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-31628857

RESUMO

INTRODUCTION: A previously developed Obstetric Comorbidity Index has been validated in highly selected cohorts. Validation of the index in an unselected population as well as in other health registers is, however, of high importance to determine external validity. MATERIAL AND METHODS: Using nationwide registers, we formed a nationwide cohort including completed pregnancies (both live- and stillborn) in Denmark from 2000 through 2014. Maternal age and 20 comorbid conditions were assessed and weighted. Outcomes were maternal end-organ injury or death within 30 days postpartum. The index's predictive and discriminative ability was estimated by Brier score and the area under the receiver operating characteristic curve (AUC), respectively. Logistic regression analysis was used to estimate odds ratios (OR) with 95% confidence interval (CI). RESULTS: In 876 496 completed pregnancies by 527 079 women, 1.40% (n = 12 314) experienced an outcome. The majority of women (64.1%) did not have any record of a condition included in the index and only 0.3% (n = 3044) had a score >6. The incidence of an outcome increased with increasing comorbidity score from 0.9% (95% CI 0.8-0.9) in women scoring 0% to 10.4% (95% CI 7.6-13.9) in women scoring 9-10. Compared with women scoring 0, a score of 1-2 yielded an OR of 2.34 (95% CI 2.25-2.44), 3-4 an OR of 5.16 (95% CI 4.81-5.54), 5-6 an OR of 4.84 (95% CI 4.31-5.44), and 8-9 an OR of 7.97 (95% CI 6.54-9.72) for experiencing the outcome. The index had a Brier score of 0.01 and an AUC of 0.64. CONCLUSIONS: Despite potential weaknesses in the outcome definition, the Obstetric Comorbidity Index showed a moderate ability to discriminate and predict end-organ injury and death in a nationwide cohort in Denmark, in accordance with previous findings. These results suggest that the index may be a useful tool to control for confounding in health research and clinically to identify women at high risk for adverse maternal outcomes.

12.
Epidemiology ; 31(1): 82-89, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31569120

RESUMO

Estimating hazard ratios (HR) presents challenges for propensity score (PS)-based analyses of cohorts with differential depletion of susceptibles. When the treatment effect is not null, cohorts that were balanced at baseline tend to become unbalanced on baseline characteristics over time as "susceptible" individuals drop out of the population at risk differentially across treatment groups due to having outcome events. This imbalance in baseline covariates causes marginal (population-averaged) HRs to diverge from conditional (covariate-adjusted) HRs over time and systematically move toward the null. Methods that condition on a baseline PS yield HR estimates that fall between the marginal and conditional HRs when these diverge. Unconditional methods that match on the PS or weight by a function of the PS can estimate the marginal HR consistently but are prone to misinterpretation when the marginal HR diverges toward the null. Here, we present results from a series of simulations to help analysts gain insight on these issues. We propose a novel approach that uses time-dependent PSs to consistently estimate conditional HRs, regardless of whether susceptibles have been depleted differentially. Simulations show that adjustment for time-dependent PSs can adjust for covariate imbalances over time that are caused by depletion of susceptibles. Updating the PS is unnecessary when outcome incidence is so low that depletion of susceptibles is negligible. But if incidence is high, and covariates and treatment affect risk, then covariate imbalances arise as susceptibles are depleted, and PS-based methods can consistently estimate the conditional HR only if the PS is periodically updated.

13.
Clin Pharmacol Ther ; 2019 Dec 23.
Artigo em Inglês | MEDLINE | ID: mdl-31872419

RESUMO

The anticoagulant response to warfarin, a narrow therapeutic index drug, increases with age, which may make older patients susceptible to adverse outcomes resulting from small differences in bioavailability between generic and brand products. Using US Medicare claims linked to electronic medical records from two large hospitals in Boston, we designed a cohort study of ≥ 65-year-old patients. Patients were followed for a composite effectiveness outcome of ischemic stroke or venous thromboembolism, a composite safety outcome, including major hemorrhage, and a 1-year all-cause mortality outcome. After propensity score fine-stratification and weighting to account for > 90 confounders, hazard ratios comparing brand vs. generic warfarin initiators (95% confidence intervals) for the effectiveness, safety, and all-cause mortality outcomes, were 0.97 (0.65-1.46), 0.94 (0.65-1.35), and 0.84 (0.62-1.13), respectively. Results from subgroup analyses of patients with atrial fibrillation, CHADS-VASc score ≥ 3, and HAS-BLED score ≥ 3 were consistent with the primary analysis.

14.
Epidemiology ; 30(6): 861-866, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31430267

RESUMO

BACKGROUND: Self-controlled designs, both case-crossover and self-controlled case series, are well suited for evaluating outcomes of drug-drug interactions in electronic healthcare data. Their comparative performance in this context, however, is unknown. METHODS: We simulated cohorts of patients exposed to two drugs: a chronic drug (object) and a short-term drug (precipitant) with an associated interaction of 2.0 on the odds ratio scale. We analyzed cohorts using case-crossover and self-controlled case series designs evaluating exposure to the precipitant drug within person-time exposed to the object drug. Scenarios evaluated violations of key design assumptions: (1) time-varying, within-person confounding; (2) time trend in precipitant drug exposure prevalence; (3) nontransient precipitant exposure; and (4) event-dependent object drug discontinuation. RESULTS: Case-crossover analysis produced biased estimates when 30% of patients persisted on the precipitant drug (estimated OR 2.85) and when the use of the precipitant drug was increasing in simulated cohorts (estimated OR 2.56). Self-controlled case series produced biased estimates when patients discontinued the object drug following the occurrence of an outcome (estimated incidence ratio [IR] of 2.09 [50% of patients stopping therapy] and 2.22 [90%]). Both designs yielded similarly biased estimates in the presence of time-varying, within-person confounding. CONCLUSION: In settings with independent or rare outcomes and no substantial event-dependent censoring (<50%), self-controlled case series may be preferable to case-crossover design for evaluating outcomes of drug-drug interactions. With frequent event-dependent drug discontinuation, a case-crossover design may be preferable provided there are no time-related trends in drug exposure.

15.
Drug Saf ; 42(11): 1297-1309, 2019 11.
Artigo em Inglês | MEDLINE | ID: mdl-31452075

RESUMO

Research that makes secondary use of administrative and clinical healthcare databases is increasingly influential for regulatory, reimbursement, and other healthcare decision-making. Consequently, there are numerous guidance documents on reporting for studies that use 'real-world' data captured in administrative claims and electronic health record (EHR) databases. These guidance documents are intended to improve transparency, reproducibility, and the ability to evaluate validity and relevance of design and analysis decisions. However, existing guidance does not differentiate between structured and unstructured information contained in EHRs, registries, or other healthcare data sources. While unstructured text is convenient and readily interpretable in clinical practice, it can be difficult to use for investigation of causal questions, e.g., comparative effectiveness and safety, until data have been cleaned and algorithms applied to extract relevant information to structured fields for analysis. The goal of this paper is to increase transparency for healthcare decision makers and causal inference researchers by providing general recommendations for reporting on steps taken to make unstructured text-based data usable for comparative effectiveness and safety research. These recommendations are designed to be used as an adjunct for existing reporting guidance. They are intended to provide sufficient context and supporting information for causal inference studies involving use of natural language processing- or machine learning-derived data fields, so that researchers, reviewers, and decision makers can be confident in their ability to evaluate the validity and relevance of derived measures for exposures, inclusion/exclusion criteria, covariates, and outcomes for the causal question of interest.

16.
Artigo em Inglês | MEDLINE | ID: mdl-31298463

RESUMO

PURPOSE: As more biosimilars become available in the United States, postapproval noninterventional studies describing biosimilar switching and comparing effectiveness and/or safety between switchers and nonswitchers will play a key role in generating real-world evidence to inform clinical practices and policy decisions. Ensuring sound methodology is critical for making valid inferences from these studies. METHODS: The Biologics and Biosimilars Collective Intelligence Consortium (BBCIC) convened a workgroup consisting of academic researchers, industry scientists, and practicing clinicians to establish best practice recommendations for the conduct of noninterventional studies of biosimilar and reference biologic switching. The workgroup members participated in eight teleconferences between August 2017 and February 2018 to discuss specific topics and build consensus. RESULTS: This report provides workgroup recommendations covering five main considerations relating to noninterventional studies describing reference biologic to biosimilar switching and comparing reference biologic to biosimilars for safety and effectiveness in the presence of switching at treatment initiation and during follow-up: (a) selecting appropriate data sources from a range of available options including insurance claims, electronic health records, and registries; (b) study designs; (c) outcomes of interest including health care utilization and clinical endpoints; (d) analytic approaches including propensity scores, disease risk scores, and instrumental variables; and (e) special considerations including avoiding designs that ignore history of biologic use, avoiding immortal time bias, exposure misclassification, and accounting for postindex switching. CONCLUSION: Recommendations provided in this report provide a framework that may be helpful in designing and critically evaluating postapproval noninterventional studies involving reference biologic to biosimilar switching.

17.
Drug Saf ; 42(11): 1355-1363, 2019 11.
Artigo em Inglês | MEDLINE | ID: mdl-31321714

RESUMO

INTRODUCTION: Patients taking non-vitamin K antagonist oral anticoagulants (NOACs) such as dabigatran, rivaroxaban, and apixaban have reported experiencing angioedema in randomized trials and routine care. OBJECTIVE: The aim of this study was to quantify the association between NOACs and angioedema relative to warfarin among routinely treated patients with atrial fibrillation in a cohort study. We also compared warfarin users with non-users in a case-crossover study. METHODS: We utilized a cohort design that drew eligible patients from the Truven Health MarketScan Commercial database, the Optum© Clinformatics® Data Mart, and Medicare. Within each database, we compared the 6-month relative rate of angioedema among new users of NOACs (dabigatran, rivaroxaban, apixaban) and new users of warfarin. We estimated hazard ratios (HRs) and 95% confidence intervals (CIs) after adjusting for confounders using propensity score stratification, and meta-analyzed the database-specific HRs using a random-effects model. We also estimated an odds ratio (OR) for the association between warfarin and angioedema using a case-crossover design, a self-controlled design that controls for time-invariant confounders. RESULTS: In the cohort study, we observed 249 incident angioedema events among 267,681 NOAC initiators and 281,143 warfarin initiators across all databases. The meta-analyzed HR for angioedema comparing any NOAC versus warfarin was 0.98 (95% CI 0.76-1.27). In the case-crossover design, the OR for the association between warfarin and angioedema was 0.91 (95% CI 0.68-1.21) based on 431 cases. CONCLUSIONS: Our estimates were inconsistent with substantial short-term relative increases in the rate of angioedema associated with oral anticoagulant therapy.

18.
EGEMS (Wash DC) ; 7(1): 27, 2019 Jul 15.
Artigo em Inglês | MEDLINE | ID: mdl-31346542

RESUMO

Purpose: Little is known about how disease risk score (DRS) development should proceed under different pharmacoepidemiologic follow-up strategies. In an analysis of dabigatran vs. warfarin and risk of major bleeding, we compared the results of DRS adjustment when models were developed under "intention-to-treat" (ITT) and "as-treated" (AT) approaches. Methods: We assessed DRS model discrimination, calibration, and ability to induce prognostic balance via the "dry run analysis". AT treatment effects stratified on each DRS were compared with each other and with a propensity score (PS) stratified reference estimate. Bootstrap resampling of the historical cohort at 10 percent-90 percent sample size was performed to assess the impact of sample size on DRS estimation. Results: Historically-derived DRS models fit under AT showed greater decrements in discrimination and calibration than those fit under ITT when applied to the concurrent study population. Prognostic balance was approximately equal across DRS models (-6 percent to -7 percent "pseudo-bias" on the hazard ratio scale). Hazard ratios were between 0.76 and 0.78 with all methods of DRS adjustment, while the PS stratified hazard ratio was 0.83. In resampling, AT DRS models showed more overfitting and worse prognostic balance, and led to hazard ratios further from the reference estimate than did ITT DRSs, across sample sizes. Conclusions: In a study of anticoagulant safety, DRSs developed under an AT principle showed signs of overfitting and reduced confounding control. More research is needed to determine if development of DRSs under ITT is a viable solution to overfitting in other settings.

19.
Am J Obstet Gynecol ; 221(3): 271.e1-271.e10, 2019 09.
Artigo em Inglês | MEDLINE | ID: mdl-31229427

RESUMO

BACKGROUND: The obstetric comorbidity index summarizes the burden of maternal comorbidities into a single number and holds promise as a maternal risk-assessment tool. OBJECTIVE: The aim of this study was to assess the clinical performance of this comorbidity-based screening tool to accurately identify women on labor and delivery who are at risk of severe maternal morbidity on labor and delivery in real time. STUDY DESIGN: All patients with pregnancies ≥23 weeks gestation presenting to labor and delivery at a single tertiary-care center from February through July 2018 were included in the study. The patient's primary labor and delivery nurse assessed patient comorbidities and calculated the patient's obstetric comorbidity index. The score was recalculated at each 12-hour shift change. A multidisciplinary panel of clinicians determined whether patients experienced severe maternal morbidity based on the American College of Obstetrics and Gynecology and Society for Maternal-Fetal Medicine consensus definition, blinded to the patient's obstetric comorbidity index score. We analyzed the association between the obstetric comorbidity index score and the occurrence of severe maternal morbidity. RESULTS: The study included 2828 women, of whom 1.73% experience severe maternal morbidity (n=49). The obstetric comorbidity index ranged from 0-15 for women in the study cohort, with a median obstetric comorbidity index of 1 (interquartile range, 0-3). The median obstetric comorbidity index score for women who experienced the severe maternal morbidity was 5 (interquartile range, 3-7) compared with a median of 1 (interquartile range, 0-3) for those without severe maternal morbidity (P<.01). The frequency of severe maternal morbidity increased from 0.41% for those with a score of 0 to 18.75% for those with a score ≥9. For every 1-point increase in the score, patients experienced a 1.55 increase in odds of severe maternal morbidity (95% confidence interval, 1.42-1.70). The c-statistic for the obstetric comorbidity index score was 0.83 (95% confidence interval, 0.76-0.89), which indicated strong discrimination. CONCLUSION: The obstetric comorbidity index can prospectively identify women at risk of severe maternal morbidity in a clinical setting. A particular strength of the obstetric comorbidity index is its ability to integrate multiple compounding comorbidities and highlight the cumulative risk that is associated with the patients' conditions. Routine clinical use of the obstetric comorbidity index has the potential to identify at-risk women whose condition warrants increased surveillance and targeted care to prevent adverse maternal outcomes.


Assuntos
Complicações na Gravidez/diagnóstico , Adulto , Boston/epidemiologia , Comorbidade , Parto Obstétrico , Feminino , Humanos , Complicações do Trabalho de Parto/diagnóstico , Complicações do Trabalho de Parto/epidemiologia , Complicações do Trabalho de Parto/etiologia , Complicações do Trabalho de Parto/prevenção & controle , Gravidez , Complicações na Gravidez/epidemiologia , Estudos Prospectivos , Medição de Risco , Índice de Gravidade de Doença
20.
JAMA Intern Med ; 2019 Jun 24.
Artigo em Inglês | MEDLINE | ID: mdl-31233088

RESUMO

Importance: Prescription opioid misuse is a public health problem that leads to overdose. Although existing interventions focus on limiting prescribing to patients at high risk, individuals may still access prescription opioids dispensed to family members. Objective: To determine whether opioid prescriptions to family members were associated with overdose for individuals who themselves did not have an opioid prescription. Design, Setting, and Participants: We conducted a 1:4 matched case-control study using health care utilization data from 2004 through 2015 from a large US commercial insurance company. Eligible individuals were required to have at least 12 months of continuous enrollment and 1 or more family members in the database. Individuals who experienced overdose were identified by their first opioid overdose after the baseline period and matched to control participants by time in the database, calendar time, age, sex, and number of individuals in the family unit. Both groups were restricted to individuals with no prior opioid dispensing of their own. Data analysis was conducted from January 2018 to August 2018. Exposures: Any prior opioid dispensing to a family member, total morphine milligram equivalents dispensed to family members, and the type of opioid product dispensed. Main Outcomes and Measures: Individual odds of opioid overdose resulting in an emergency department visit or hospitalization were the primary end point. The primary analysis evaluated the odds of overdose among individuals whose family members had been dispensed an opioid. Sensitivity analyses examined the odds stratified by age and timing relative to the dispensing of opioids to family members. Results: A total of 2303 individuals who experienced opioid overdose and 9212 matched control individuals were identified. The mean (SD) age was 23.2 (18.1) years; 1158 affected individuals and 4632 control individuals (50.3%) were female. The mean (SD) time in the database before an overdose case was 3.2 (3.3) years. Prior opioid dispensing to family members was associated with individual overdose (odds ratio [OR], 2.89 [95% CI, 2.59-3.23]). There was a significant dose-response association between increasing amounts of opioids dispensed to family members and odds of overdose (>0-<50 morphine milligram equivalents per day: OR, 2.71 [95% CI, 2.42-3.03]; 50-<90 morphine milligram equivalents per day: OR, 7.80 [95% CI, 3.63-16.78]; ≥90 morphine milligram equivalents per day: OR, 15.08 [95% CI, 8.66-26.27]). Conclusions and Relevance: In this analysis, opioid prescriptions to family members were associated with overdose among individuals who do not receive opioid prescriptions. Interventions may focus on expanding access to opioid antagonists, locking prescription opioids in the home, and providing greater patient education to limit fatal overdose among family members.

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