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1.
Clin Infect Dis ; 2021 Aug 09.
Artigo em Inglês | MEDLINE | ID: mdl-34370014

RESUMO

BACKGROUND: The profound changes wrought by COVID-19 on routine hospital operations may have influenced performance on hospital measures, including healthcare-associated infections (HAIs). We aimed to evaluate the association between COVID-19 surges and HAI and cluster rates. METHODS: In 148 HCA Healthcare-affiliated hospitals, 3/1/2020-9/30/2020, and a subset of hospitals with microbiology and cluster data through 12/31/2020, we evaluated the association between COVID-19 surges and HAIs, hospital-onset pathogens, and cluster rates using negative binomial mixed models. To account for local variation in COVID-19 pandemic surge timing, we included the number of discharges with a laboratory-confirmed COVID-19 diagnosis per staffed bed per month. RESULTS: Central line-associated blood stream infections (CLABSI), catheter-associated urinary tract infections (CAUTI), and methicillin-resistant Staphylococcus aureus (MRSA) bacteremia increased as COVID-19 burden increased. There were 60% (95% CI, 23-108%) more CLABSI, 43% (95% CI, 8-90%) more CAUTI, and 44% (95% CI, 10-88%) more cases of MRSA bacteremia than expected over 7 months based on predicted HAIs had there not been COVID-19 cases. Clostridioides difficile infection was not significantly associated with COVID-19 burden. Microbiology data from 81 of the hospitals corroborated the findings. Notably, rates of hospital-onset bloodstream infections and multidrug resistant organisms, including MRSA, vancomycin-resistant enterococcus and Gram-negative organisms were each significantly associated with COVID-19 surges. Finally, clusters of hospital-onset pathogens increased as the COVID-19 burden increased. CONCLUSION: COVID-19 surges adversely impact HAI rates and clusters of infections within hospitals, emphasizing the need for balancing COVID-related demands with routine hospital infection prevention.

3.
Clin Pharmacol Ther ; 2021 May 01.
Artigo em Inglês | MEDLINE | ID: mdl-33932030

RESUMO

Concerns regarding both the limited generalizability and the slow pace of traditional randomized trials have led to calls for greater use of real-world evidence (RWE) in the evaluation of new treatments or products. RWE studies often rely on real-world data (RWD), including data extracted from healthcare records or data captured by mobile phones or other consumer devices. Global assessments of RWD sources are not helpful in assessing whether any specific RWD element is fit for any specific purpose. Instead, evidence generators and evidence consumers should clearly identify the specific health state or clinical phenomenon of interest and then consider each step between that clinical phenomenon and its representation in a research database. We propose specific questions regarding potential error or bias affecting each of those steps: Would a person experiencing this clinical phenomenon present for care in this setting or interact with this recording device? Would this clinical phenomenon be accurately recognized or assessed? How might the recording environment or tools affect accurate and consistent recording of this clinical phenomenon? Can data elements from different sources be harmonized, both technically (same format) and semantically (same meaning)? Can the original data elements be consistently reduced to a useful clinical phenotype? Addressing these questions requires a range of clinical, organizational, and technical expertise. Transparency regarding each step in the creation of RWD is essential if evidence consumers are to rely on RWE studies.

4.
Pharmacoepidemiol Drug Saf ; 30(7): 827-837, 2021 07.
Artigo em Inglês | MEDLINE | ID: mdl-33797815

RESUMO

The US Food and Drug Administration's Sentinel System was established in 2009 to use routinely collected electronic health data for improving the national capability to assess post-market medical product safety. Over more than a decade, Sentinel has become an integral part of FDA's surveillance capabilities and has been used to conduct analyses that have contributed to regulatory decisions. FDA's role in the COVID-19 pandemic response has necessitated an expansion and enhancement of Sentinel. Here we describe how the Sentinel System has supported FDA's response to the COVID-19 pandemic. We highlight new capabilities developed, key data generated to date, and lessons learned, particularly with respect to working with inpatient electronic health record data. Early in the pandemic, Sentinel developed a multi-pronged approach to support FDA's anticipated data and analytic needs. It incorporated new data sources, created a rapidly refreshed database, developed protocols to assess the natural history of COVID-19, validated a diagnosis-code based algorithm for identifying patients with COVID-19 in administrative claims data, and coordinated with other national and international initiatives. Sentinel is poised to answer important questions about the natural history of COVID-19 and is positioned to use this information to study the use, safety, and potentially the effectiveness of medical products used for COVID-19 prevention and treatment.


Assuntos
COVID-19/terapia , Gestão da Informação em Saúde/organização & administração , Vigilância de Produtos Comercializados/métodos , Vigilância em Saúde Pública/métodos , United States Food and Drug Administration/organização & administração , Antivirais/uso terapêutico , COVID-19/epidemiologia , COVID-19/virologia , Vacinas contra COVID-19/administração & dosagem , Vacinas contra COVID-19/efeitos adversos , Controle de Doenças Transmissíveis/legislação & jurisprudência , Bases de Dados Factuais/estatística & dados numéricos , Registros Eletrônicos de Saúde/estatística & dados numéricos , Política de Saúde , Humanos , Pandemias/prevenção & controle , Pandemias/estatística & dados numéricos , Estados Unidos/epidemiologia , United States Food and Drug Administration/legislação & jurisprudência
5.
Clin Pharmacol Ther ; 2021 Apr 25.
Artigo em Inglês | MEDLINE | ID: mdl-33895994

RESUMO

Concerns regarding both the limited generalizability and the slow pace of traditional randomized trials have led to calls for greater use of real-world evidence (RWE) in the evaluation of new treatments or products. The RWE label has been used to refer to a variety of departures from the methods of traditional randomized controlled trials. Recognizing this complexity and potential confusion, the National Academies of Science, Engineering, and Medicine convened a series of workshops to clarify and address questions regarding the use of RWE to evaluate new medical treatments. Those workshops identified three specific dimensions in which RWE studies might differ from traditional clinical trials: use of real-world data (data extracted from health system records or data captured by mobile devices), delivery of real-world treatment (open-label treatments delivered in community settings by community practitioners), and real-world treatment assignment (including nonrandomized comparisons and variations on random assignment such as before-after or stepped-wedge designs). For any RWE study, decisions regarding each of these dimensions depends on the specific research question, characteristics of the potential study settings, and characteristics of the settings where study results would be applied.

6.
Clin Pharmacol Ther ; 2021 Apr 08.
Artigo em Inglês | MEDLINE | ID: mdl-33829639

RESUMO

Concerns regarding both the limited generalizability and the slow pace of traditional randomized trials have led to calls for greater use of real-world evidence in the evaluation of new treatments or products. Real-world clinical trials or pragmatic trials often differ from traditional clinical trials in the use of open-label or nonblinded treatments delivered by real-world clinicians in community practice settings. Blinding and standardization of treatment may sometimes be necessary for internal validity, but they may also obscure or distort meaningful differences between treatments. When investigators consider whether blinding of clinicians, patients, or assessors is necessary, we suggest they consider several specific questions: Will clinicians, patients, and assessors have expectations or preferences regarding benefits or adverse effects? How might those expectations affect treatment uptake, treatment adherence, or assessment of outcomes? Will expectations differ in the settings where trial results will be applied? How would blinding of treatment reduce biases? How would blinding obscure true differences between treatments? How would procedures necessary for blinding reduce acceptability or increase risk of trial participation? When investigators consider how strictly treatments should be standardized, we suggest they consider several specific questions: How would treatment effectiveness or safety vary according to clinician experience or expertise? What level of experience or expertise is available in potential trial settings and settings where trial results would be applied? Is some level of standardization necessary for valid inference? Considering any special vulnerabilities of the study population, is some level of standardization necessary to assure participant safety?

7.
Clin Pharmacol Ther ; 2021 Apr 07.
Artigo em Inglês | MEDLINE | ID: mdl-33826756

RESUMO

The randomized controlled trial (RCT) is the gold standard for evaluating the causal effects of medications. Limitations of RCTs have led to increasing interest in using real-world evidence (RWE) to augment RCT evidence and inform decision making on medications. Although RWE can be either randomized or nonrandomized, nonrandomized RWE can capitalize on the recent proliferation of large healthcare databases and can often answer questions that cannot be answered in randomized studies due to resource constraints. However, the results of nonrandomized studies are much more likely to be impacted by confounding bias, and the existence of unmeasured confounders can never be completely ruled out. Furthermore, nonrandomized studies require more complex design considerations which can sometimes result in design-related biases. We discuss questions that can help investigators or evidence consumers evaluate the potential impact of confounding or other biases on their findings: Does the design emulate a hypothetical randomized trial design? Is the comparator or control condition appropriate? Does the primary analysis adjust for measured confounders? Do sensitivity analyses quantify the potential impact of residual confounding? Are methods open to inspection and (if possible) replication? Designing a high-quality nonrandomized study of medications remains challenging and requires broad expertise across a range of disciplines, including relevant clinical areas, epidemiology, and biostatistics. The questions posed in this paper provide a guiding framework for assessing the credibility of nonrandomized RWE and could be applied across many clinical questions.

8.
Pharmacoepidemiol Drug Saf ; 30(8): 1066-1073, 2021 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-33715299

RESUMO

PURPOSE: Prescribing cascades occur when a physician prescribes a new drug to address the side-effect of another drug. Persons with Alzheimer's disease and related dementias (ADRD) are at increased risk for prescribing cascades. Our objective was to develop an approach to estimating the proportion of calcium channel blocker-diuretic (CCB-diuretic) prescribing cascades among persons with ADRD in two U.S. health plans. METHODS: We identified patients aged ≥50 on January 1, 2017, dispensed a drug to treat ADRD in the 365-days prior to/on cohort entry date. Patients had medical/pharmacy coverage for 1 year before and through cohort entry. We excluded individuals with an institutional stay encounter in the 45 days prior to cohort entry and censored patients based on: disenrollment from coverage, death, or end of data. We identified incident and prevalent CCB use in the 183-days following cohort entry, and identified subsequent incident diuretic use among incident and prevalent CCB-users within 365-days from cohort entry. RESULTS: There were 121 538 eligible patients. Approximately 62% were female, with a mean age of 79.5 (SD ±8.6). Overall 2.1% of the cohort experienced a prevalent CCB-diuretic prescribing cascade with 1586 incident diuretic-users among 36 462 prevalent CCB-users (4.3%, 95% CI 4.1-4.6%]); and there were161 incident diuretic-users among 3304 incident CCB-users (4.9%, 95% CI 4.2-5.7%) (incident CCB-diuretic cascade). CONCLUSIONS: We describe an approach to identify prescribing cascades in persons with ADRD, which can be used to assess the proportion of prescribing cascades in large cohorts. We determined the proportion of CCB-diuretic prescribing cascades was low.

9.
J Am Geriatr Soc ; 69(5): 1328-1333, 2021 05.
Artigo em Inglês | MEDLINE | ID: mdl-33432578

RESUMO

OBJECTIVES: Persons living with Alzheimer's disease (AD) may be at increased risk for prescribing cascades due to greater multimorbidity, polypharmacy, and the need for more complex care. Our objective was to assess the proportion of the antidopaminergic-antiparkinsonian medication prescribing cascades among persons living with Alzheimer's disease. SETTING: Two large administrative claims databases in the United States. PARTICIPANTS: We identified patients aged ≥50 on January 1, 2017, who were dispensed a drug used to treat Alzheimer's disease for at least 1 day in the 365 days prior to or on cohort entry date and who had medical and pharmacy coverage in the 365 days prior to the cohort entry date. We excluded individuals with a recent institutional stay. We identified incident antidopaminergic (antipsychotic/metoclopramide) use in the 183 days following cohort entry and identified subsequent incident antiparkinsonian drug use within 8 to 365 days. RESULTS: There were 121,538 patients with Alzheimer's disease eligible for inclusion. Approximately 62% were women with a mean age of 79.5 (SD ± 8.6). The mean number of drugs dispensed was 9.2 (SD ± 4.9). There were 36 incident antiparkinsonian users among 4,534 incident antipsychotic/metoclopramide users (0.8%). CONCLUSION: We determined that the proportion of antidopaminergic-antiparkinsonian medication prescribing cascades, widely considered as high-priority, was low. Our approach can be used to assess the proportion of prescribing cascades in populations considered to be at high risk and to prioritize system-level interventional efforts to improve medication safety in these patients.


Assuntos
Doença de Alzheimer/tratamento farmacológico , Antiparkinsonianos/uso terapêutico , Antagonistas de Dopamina/uso terapêutico , Prescrições de Medicamentos/estatística & dados numéricos , Idoso , Idoso de 80 Anos ou mais , Doença de Alzheimer/complicações , Estudos de Coortes , Bases de Dados Factuais , Feminino , Humanos , Masculino , Farmácia/estatística & dados numéricos , Polimedicação , Padrões de Prática Médica/estatística & dados numéricos , Estados Unidos
10.
J Clin Epidemiol ; 129: 60-67, 2021 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-33002635

RESUMO

OBJECTIVE: To describe PCORnet, a clinical research network developed for patient-centered outcomes research on a national scale. STUDY DESIGN AND SETTING: Descriptive study of the current state and future directions for PCORnet. We conducted cross-sectional analyses of the health systems and patient populations of the 9 Clinical Research Networks and 2 Health Plan Research Networks that are part of PCORnet. RESULTS: Within the Clinical Research Networks, electronic health data are currently collected from 337 hospitals, 169,695 physicians, 3,564 primary care practices, 338 emergency departments, and 1,024 community clinics. Patients can be recruited for prospective studies from any of these clinical sites. The Clinical Research Networks have accumulated data from 80 million patients with at least one visit from 2009 to 2018. The PCORnet Health Plan Research Network population of individuals with a valid enrollment segment from 2009 to 2019 exceeds 60 million individuals, who on average have 2.63 years of follow-up. CONCLUSION: PCORnet's infrastructure comprises clinical data from a diverse cohort of patients and has the capacity to rapidly access these patient populations for pragmatic clinical trials, epidemiological research, and patient-centered research on rare diseases.

11.
Clin Infect Dis ; 72(1): 90-98, 2021 01 23.
Artigo em Inglês | MEDLINE | ID: mdl-31918439

RESUMO

BACKGROUND: The Centers for Medicare and Medicaid Services (CMS) use colon surgical site infection (SSI) rates to rank hospitals and apply financial penalties. The CMS' risk-adjustment model omits potentially impactful variables that might disadvantage hospitals with complex surgical populations. METHODS: We analyzed adult patients who underwent colon surgery within facilities associated with HCA Healthcare from 2014 to 2016. SSIs were identified from National Health Safety Network (NHSN) reporting. We trained and validated 3 SSI prediction models, using (1) current CMS model variables, including hospital-specific random effects (HCA-adapted CMS model); (2) demographics and claims-based comorbidities (expanded-claims model); and (3) demographics, claims-based comorbidities, and NHSN variables (claims-plus-electronic health record [EHR] model). Discrimination, calibration, and resulting rankings were compared among all models and the current CMS model with published coefficient values. RESULTS: We identified 39 468 colon surgeries in 149 hospitals, resulting in 1216 (3.1%) SSIs. Compared to the HCA-adapted CMS model, the expanded-claims model had similar performance (c-statistic, 0.65 vs 0.67, respectively), while the claims-plus-EHR model was more accurate (c-statistic, 0.70; 95% confidence interval, .67-.73; P = .004). The sampling variation, due to the low surgical volume and small number of infections, contributed 74% of the total variation in observed SSI rates between hospitals. When CMS model rankings were compared to those from the expanded-claims and claims-plus-EHR models, 18 (15%) and 26 (22%) hospitals changed quartiles, respectively, and 10 (8.3%) and 12 (10%) hospitals changed into or out of the lowest-performing quartile, respectively. CONCLUSIONS: An expanded set of variables improved colon SSI risk predictions and quartile assignments, but low procedure volumes and SSI events remain a barrier to effectively comparing hospitals.


Assuntos
Procedimentos Cirúrgicos do Sistema Digestório , Medicare , Adulto , Idoso , Colo/cirurgia , Hospitais , Humanos , Estudos Retrospectivos , Infecção da Ferida Cirúrgica/epidemiologia , Estados Unidos/epidemiologia
12.
Ther Adv Drug Saf ; 11: 2042098620968310, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-33240479

RESUMO

Introduction: Prescribing cascades occur when the side effect of a drug is misinterpreted as a new medical condition, and a second drug is prescribed to address the side effect. Persons with Alzheimer's disease (AD) are at increased risk of prescribing cascades due to greater multimorbidity, polypharmacy, and complexity of care. The objective of this study was to evaluate educational materials about prescribing cascades in persons with AD, and elicit input on their use in a future trial. Methods: We interviewed community-dwelling adults with either an AD diagnosis or a prescription drug used to treat AD (n = 12), caregivers of patients meeting the same criteria (n = 14), and providers (n = 15). We coded interview transcripts and organized themes according to the communication-human information processing model. We revised the materials based on the interviews, and surveyed participating caregivers and providers for their reactions to the revised materials. Results: Analysis of patients', caregivers', and providers' comments suggest: (a) Providers had conflicting views about the messaging of materials; (b) Caregivers were likely to read letters addressed to patients; (c) Providers were likely to ignore letters, but were receptive to patient/caregiver-initiated conversations; (d) Patients and caregivers had difficulty understanding prescribing cascades; (e) Providers worried that mailed materials would undermine trust; (f) Participants had mixed views on how materials might affect the clinical encounter; (g) Participants felt that materials would improve patient/caregiver engagement. When surveyed, most providers found the revised materials informative and actionable, and most caregivers found them understandable and useful. Conclusions: This evaluation of educational materials about prescribing cascades in patients with AD provides strong support for engaging caregivers to communicate with providers about prescribing cascades. By giving patients and caregivers a basic description of the prescribing cascade concept, our educational materials may help them prepare for a conversation with the provider, who can then tailor the discussion of the possible cascade to the specific needs of the individual patient and caregiver. However, evidence on whether materials can stimulate such conversations awaits testing in a future trial. Lay summary: Patient, caregiver and provider thoughts on educational materials about prescribing and medication safety Prescribing cascades occur when the side effect of a medication is misinterpreted as a new medical condition, and a second medication is prescribed to treat the side effect. Persons with Alzheimer's disease (AD) are at increased risk of prescribing cascades because they often have more medical conditions, more medications, and more complex care. The goal of this study was to evaluate mailed educational materials about prescribing cascades in persons with AD, and get input on their use in a future study. We interviewed 12 adults with AD, or prescribed a medication to treat AD, 14 caregivers of persons with AD, and 15 providers. We reviewed the interview transcripts to identify important findings about our educational materials. We edited the materials based on the interviews, and sent participating caregivers and providers a questionnaire to get their reactions to the new materials. Important findings from the interviews suggest: (a) Providers had conflicting views about the recommendations given; (b) Caregivers were likely to read letters addressed to patients; (c) Providers were likely to ignore letters, but were receptive to patients/caregivers introducing the topic; (d) Patients and caregivers had difficulty understanding prescribing cascades; (e) Providers worried mailed materials would undermine trust; (f) Participants had mixed views on how materials might affect a doctor's appointment; (g) Participants felt strongly that materials would improve patient/caregiver engagement. When surveyed, almost all providers found the revised materials informative and actionable; and most caregivers found them understandable and useful. These findings provide strong support for engaging caregivers to communicate with providers about prescribing cascades. The educational materials may help patients and caregivers prepare for a conversation with the provider, who can then tailor the discussion of the possible cascade to the specific needs of the individual patient and caregiver. However, evidence on whether materials can stimulate such conversations awaits testing in a future study.

13.
J Am Soc Nephrol ; 31(11): 2506-2516, 2020 11.
Artigo em Inglês | MEDLINE | ID: mdl-33077615

RESUMO

The Sentinel System is a national electronic postmarketing resource established by the US Food and Drug Administration to support assessment of the safety and effectiveness of marketed medical products. It has built a large, multi-institutional, distributed data network that contains comprehensive electronic health data, covering about 700 million person-years of longitudinal observation time nationwide. With its sophisticated infrastructure and a large selection of flexible analytic tools, the Sentinel System permits rapid and secure analyses, while preserving patient privacy and health-system autonomy. The Sentinel System also offers enhanced capabilities, including accessing full-text medical records, supporting randomized clinical trials embedded in healthcare delivery systems, and facilitating effective collection of patient-reported data using mobile devices, among many other research programs. The nephrology research community can use the infrastructure, tools, and data that this national resource offers for evidence generation. This review summarizes the Sentinel System and its ability to rapidly generate high-quality, real-world evidence; discusses the program's experience in, and potential for, addressing gaps in kidney care; and outlines avenues for conducting research, leveraging this national resource in collaboration with Sentinel investigators.


Assuntos
Bases de Dados de Produtos Farmacêuticos , Vigilância de Produtos Comercializados , Insuficiência Renal Crônica/terapia , Pesquisa Biomédica , Sistemas de Informação em Saúde , Humanos , Estados Unidos , United States Food and Drug Administration
14.
Am Heart J ; 229: 110-117, 2020 11.
Artigo em Inglês | MEDLINE | ID: mdl-32949986

RESUMO

BACKGROUND: Many studies showing underuse of oral anticoagulants (OACs) in patients with atrial fibrillation (AF) predated the advent of the non-vitamin K antagonist OACs. We retrospectively examined use of OACs in a large commercially insured population. METHODS: Administrative claims data from 4 research partners participating in FDA-Catalyst, a program of the Sentinel Initiative, were queried in September 2017. Patients were included if they were ≥30 years old with ≥365 days of medical/pharmacy coverage, and had ≥2 diagnosis codes for AF, a CHA2DS2-VASc score ≥2, absence of contraindications to OAC use, and no evidence of OAC use in the 365 days before the index AF diagnosis. The main outcome measures of the current analysis were rates of OAC use in the prior 12 months of cohort identification and factors associated with non-use. RESULTS: A total of 197,806 AF patients met the eligibility criteria prior to assessment of OAC treatment. Of these, 179,580 (91%) patients were ≥65 years old and 73,286 (37%) patients were ≥80 years old. Half of the patients (98,903) were randomized to the early intervention arm in the IMPACT-AFib trial and constitute the cohort for this analysis. Of these, 32,295 (33%) had no evidence of OAC use in the prior 12 months. Compared with patients with evidence of OAC use in the prior 12 months, patients without OAC use were more likely to be ≥80 years old, women, and have a history of anemia (51% vs 47%) and less likely to have diabetes (41% vs 44%), history of stroke or TIA (15% vs 19%), and history of heart failure (39% vs 48%). CONCLUSIONS: Despite a high risk of stroke, one-third of privately insured patients with AF and no obvious contraindications to an OAC were not treated with an OAC. There is an unmet need for evidence-based interventions that could lead to greater use of OACs in patients with AF at risk for stroke.


Assuntos
Anticoagulantes , Fibrilação Atrial/tratamento farmacológico , Mau Uso de Serviços de Saúde , Seguro Saúde/estatística & dados numéricos , Acidente Vascular Cerebral , Administração Oral , Idoso , Idoso de 80 Anos ou mais , Anticoagulantes/administração & dosagem , Anticoagulantes/efeitos adversos , Anticoagulantes/classificação , Fibrilação Atrial/complicações , Fibrilação Atrial/economia , Fibrilação Atrial/epidemiologia , Comorbidade , Feminino , Mau Uso de Serviços de Saúde/prevenção & controle , Mau Uso de Serviços de Saúde/estatística & dados numéricos , Necessidades e Demandas de Serviços de Saúde/organização & administração , Humanos , Masculino , Melhoria de Qualidade , Medição de Risco/métodos , Fatores de Risco , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/prevenção & controle , Estados Unidos/epidemiologia
15.
Healthc (Amst) ; 8(4): 100462, 2020 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-32992106

RESUMO

Opportunities to advance science increasingly arise through investigations embedded within routine clinical practice in the form of learning health systems. Such activities challenge conventional approaches to research regulation that have not caught up with those opportunities, often imposing burdens generalized from riskier research. We analyze the rules and conventions in the US, demonstrating how even those rules are compatible with a much more flexible approach to participant risk, institutional oversight, participant consent, and disclosure for low-risk learning activities in all jurisdictions.

16.
Alzheimers Dement (Amst) ; 12(1): e12048, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32647744

RESUMO

Introduction: One-third of Medicare beneficiaries are enrolled in Medicare Advantage (MA). Yet, little is known about MA beneficiaries diagnosed with Alzheimer's disease (AD) and AD-related dementias (AD/ADRD). Methods: We calculated the prevalence of AD/ADRD diagnoses in 2014 and 2016 in three MA plans. We determined the demographic characteristics of beneficiaries diagnosed with AD/ADRD, and whether they disenrolled from the MA plan for any reason within 364 days from the index date. Results: In 2014 and 2016, the overall prevalence of AD/ADRD diagnoses was 5.6% and 6.5%, respectively. In 2016, AD/ADRD beneficiaries were on average 82.4 (SD = 7.4) years of age, 61.8% female, and had multiple comorbidities. By 364 days post-index date, 32% of beneficiaries with AD/ADRD had disenrolled from their plan. The demographic characteristics of 2014 beneficiaries with diagnosed AD/ADRD were similar to their 2016 counterparts. Discussion: The prevalence of AD/ADRD diagnosis in MA is lower than rates reported in Medicare fee-for-service.

18.
Clin Trials ; 17(4): 360-367, 2020 08.
Artigo em Inglês | MEDLINE | ID: mdl-32589056

RESUMO

IMPACT-AFib was an 80,000-patient randomized clinical trial implemented by five US insurance companies (health plans) aimed at increasing the use of oral anticoagulants by individuals with atrial fibrillation who were at high risk of stroke and not on treatment. The underlying thesis was that patients could be change agents to initiate prescribing discussions with their providers. We tested the effect of mailing information to both patients and their providers. We used administrative medical claims and pharmacy dispensing data to identify eligible patients, to randomize them to an early or delayed intervention, and to assess clinical outcomes. The core data were analysis-ready datasets each site had created and curated for the FDA's Sentinel System, supplemented by updated "fresh" pharmacy and enrollment data to ensure eligibility at the time of intervention. Following mutually agreed upon procedures, sites linked to additional internal source data to implement the intervention-educational information mailed to patients and their providers in the early intervention arm, and to providers of patients in the delayed intervention arm approximately 12 months later. The primary analysis compares the early intervention arm to the delayed intervention arm, prior to the delayed intervention being conducted (i.e. compares intervention to non-intervention). The endpoints of interest were evidence of initiation of anticoagulation (primary) as well as clinical endpoints, including stroke and hospitalization for bleeding. Major challenges, some unanticipated, identified during the planning phase include convening multi-stakeholder investigator teams and advisors, addressing ethical concerns about not intervening in a usual care comparison group, and identifying and avoiding interference with sites' routine programs that were similar to the intervention. Needs and challenges during the implementation phase included the fact that even limited site-specific programming greatly increased time and effort, the need to refresh research data extracts immediately before outreach to patients and providers, potential difficulty identifying low-cost medications such as warfarin that may not be reimbursed by health plans and so not discoverable in dispensing data, the need to develop workarounds when "providers" in claims data were facilities, difficulty addressing clustering of patients by provider because providers can have multiple identifiers within and between health plans, and the need to anticipate loss to follow up because of health plan disenrollment or change in benefits. As pragmatic trials begin to shape evidence generation within clinical practice, investigators should anticipate issues inherent to claims data and working with multiple large sites. In IMPACT-AFib, we found that investing in collaboration and communication among all parties throughout all phases of the study helped ensure common understanding, early identification of challenges, and streamlined actual implementation.


Assuntos
Anticoagulantes/uso terapêutico , Fibrilação Atrial/tratamento farmacológico , Seguro Saúde , Ensaios Clínicos Pragmáticos como Assunto/métodos , Hemorragia/epidemiologia , Hospitalização , Humanos , Ensaios Clínicos Pragmáticos como Assunto/economia , Ensaios Clínicos Controlados Aleatórios como Assunto/economia , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Projetos de Pesquisa , Acidente Vascular Cerebral/epidemiologia , Acidente Vascular Cerebral/prevenção & controle , Estados Unidos , United States Food and Drug Administration
19.
J Am Geriatr Soc ; 68 Suppl 2: S49-S54, 2020 07.
Artigo em Inglês | MEDLINE | ID: mdl-32589274

RESUMO

Embedded pragmatic clinical trials (ePCTs) are embedded in healthcare systems as well as their data environments. For people living with dementia (PLWD), settings of care can be different from the general population and involve additional people whose information is also important. The ePCT designs have the opportunity to leverage data that becomes available through the normal delivery of care. They may be particularly valuable in Alzheimer's disease and Alzheimer's disease-related dementia (AD/ADRD), given the complexity of case identification and the diversity of care settings. Grounded in the objectives of the Data and Technical Core of the newly established National Institute on Aging Imbedded Pragmatic Alzheimer's Disease and AD-Related Dementias Clinical Trials Collaboratory (IMPACT Collaboratory), this article summarizes the state of the art in using existing data sources (eg, Medicare claims, electronic health records) in AD/ADRD ePCTs and approaches to integrating them in real-world settings. J Am Geriatr Soc 68:S49-S54, 2020.


Assuntos
Atenção à Saúde , Demência/epidemiologia , Registros Eletrônicos de Saúde , Revisão da Utilização de Seguros , Avaliação de Processos e Resultados em Cuidados de Saúde , Ensaios Clínicos Pragmáticos como Assunto , Cuidadores , Humanos , Medicare/estatística & dados numéricos , Estados Unidos/epidemiologia
20.
Infect Control Hosp Epidemiol ; 41(9): 1016-1021, 2020 09.
Artigo em Inglês | MEDLINE | ID: mdl-32519624

RESUMO

OBJECTIVE: To assess the utility of an automated, statistically-based outbreak detection system to identify clusters of hospital-acquired microorganisms. DESIGN: Multicenter retrospective cohort study. SETTING: The study included 43 hospitals using a common infection prevention surveillance system. METHODS: A space-time permutation scan statistic was applied to hospital microbiology, admission, discharge, and transfer data to identify clustering of microorganisms within hospital locations and services. Infection preventionists were asked to rate the importance of each cluster. A convenience sample of 10 hospitals also provided information about clusters previously identified through their usual surveillance methods. RESULTS: We identified 230 clusters in 43 hospitals involving Gram-positive and -negative bacteria and fungi. Half of the clusters progressed after initial detection, suggesting that early detection could trigger interventions to curtail further spread. Infection preventionists reported that they would have wanted to be alerted about 81% of these clusters. Factors associated with clusters judged to be moderately or highly concerning included high statistical significance, large size, and clusters involving Clostridioides difficile or multidrug-resistant organisms. Based on comparison data provided by the convenience sample of hospitals, only 9 (18%) of 51 clusters detected by usual surveillance met statistical significance, and of the 70 clusters not previously detected, 58 (83%) involved organisms not routinely targeted by the hospitals' surveillance programs. All infection prevention programs felt that an automated outbreak detection tool would improve their ability to detect outbreaks and streamline their work. CONCLUSIONS: Automated, statistically-based outbreak detection can increase the consistency, scope, and comprehensiveness of detecting hospital-associated transmission.

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