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3.
BMC Health Serv Res ; 21(1): 1039, 2021 Oct 02.
Artigo em Inglês | MEDLINE | ID: mdl-34598702

RESUMO

BACKGROUND: This report describes how we refined a protocol for a pragmatic comparative effectiveness study of two models of an evidence-based diabetes shared medical appointment intervention and used the PRECIS-2 rating system to evaluate these adaptations. METHODS: We report primary data collected between June and August 2019, and protocol refinements completed between 2018 and 2020. Twenty-two members of the study team collaborated in protocol refinement and completed the PRECIS-2 ratings of study pragmatism. We discuss study design refinements made to achieve the desired level of pragmatism vs. experimental control for each of the nine PRECIS-2 dimensions. Study team members received training on PRECIS-2 scoring and were asked to rate the study protocol on the nine PRECIS-2 dimensions. Ratings were compared using descriptive statistics. RESULTS: In general, the PRECIS-2 ratings revealed high levels of pragmatism, but somewhat less pragmatic ratings on the categories of Delivery and Organization (costs and resources). This variation was purposeful, and we provide the rationale for and steps taken to obtain the targeted level of pragmatism on each PRECIS-2 dimension, as well as detail design changes made to a) make the design more pragmatic and b) address COVID-19 issues. There was general agreement among team members and across different types of stakeholders on PRECIS-2 ratings. CONCLUSIONS: We discuss lessons learned from use of PRECIS-2 and experiences in refining the study to be maximally pragmatic on some dimensions and less so on other dimensions. This paper expands on prior research by describing actions to achieve higher levels of pragmatism and revise our protocol fit to the changed context. We make recommendations for future use of PRECIS-2 to help address changing context and other strategies for the planning of and transparent reporting on pragmatic research and comparative effectiveness research. TRIAL REGISTRATION: Clinicaltrials.gov Registration ID: NCT03590041 .


Assuntos
COVID-19 , Diabetes Mellitus , Agendamento de Consultas , Pesquisa Comparativa da Efetividade , Diabetes Mellitus/terapia , Humanos , SARS-CoV-2
4.
Pharmacotherapy ; 41(10): 837-850, 2021 10.
Artigo em Inglês | MEDLINE | ID: mdl-34689348

RESUMO

As of August 2021, there were three COVID-19 vaccines available in the United States for the prevention of coronavirus 2019 (COVID-19). The purpose of this narrative review is to examine the early experience from the Emergency Use Authorization (EUA) of BNT162b2 (Pfizer, Inc./BioNTech), mRNA-1273 (Moderna, Inc.), and Ad26.COV2.S (Johnson and Johnson/Janssen Global Services, LLC) through July 2021. The EUA data from the clinical trials have largely been corroborated by real-world effectiveness investigations post-authorization. These studies indicate that immunity is obtained within 2 weeks post-vaccination and may endure for 6 months. The immunity conferred by the vaccines may also be effective against SARS-CoV-2 variants of concern. Additionally, populations not included in the emergency use authorization studies may also benefit from vaccination. This look back at the initial clinical experience can be used by the global community to inform and develop COVID-19 vaccine programs.


Assuntos
Vacinas contra COVID-19 , COVID-19 , COVID-19/epidemiologia , COVID-19/prevenção & controle , Vacinas contra COVID-19/classificação , Vacinas contra COVID-19/imunologia , Vacinas contra COVID-19/farmacologia , Ensaios Clínicos como Assunto , Pesquisa Comparativa da Efetividade , Humanos , Imunogenicidade da Vacina , SARS-CoV-2/efeitos dos fármacos , SARS-CoV-2/imunologia , Sociedades Farmacêuticas/tendências
6.
Medicine (Baltimore) ; 100(31): e26861, 2021 Aug 06.
Artigo em Inglês | MEDLINE | ID: mdl-34397862

RESUMO

ABSTRACT: Cardiac rehabilitation (CR) can improve clinical indicators in patients with cardiovascular diseases. The literature reports a 20% reduction in all-cause mortality and a 27% reduction in heart-disease mortality following CR. Although its clinical efficacy has been established, there is uncertainty whether center-based (CBCR) is more effective than home-based (HBCR) programs in acute and subacute phases. We aimed to verify significant differences in their effectiveness for the improvement of cardiopulmonary function by analyzing cardiopulmonary exercise (CPX) with laboratory tests following both CR programs.A single-center cohort study of 37 patients, recently diagnosed with underlying cardiovascular diseases, underwent CBCR(18) and HBCR(19). CBCR group performed a supervised exercise regimen at the CR center, for 1 hour, 2 to 3 days a week, for a total of 12 to18 weeks. HBCR group completed a self-monitored exercise program at home under the same guidelines as CBCR. Participants were evaluated by CPX with laboratory tests at 1- and 6-month, following the respective programs.There was no statistical significance in clinical characteristics and laboratory findings. Pre-post treatment comparison showed significant improvement in VO2/kg, minute ventilation/carbon dioxide production slope, breathing reserve, tidal volume (VT), heart rate recovery, oxygen consumption per heart rate, low-density lipoprotein (LDL), LDL/HDL ratio, total cholesterol, ejection fraction (EF) (P < .05). CBCR approach showed greater improvement with significance in VO2/kg, metabolic equivalents, and EF on between groups analysis (P < .05).The time effect of CPX test and laboratory data showed improvement in cardiopulmonary function and serum indicators for both groups. VO2/kg, metabolic equivalents, and EF were among the variables that showed significant differences between groups. In the acute and subacute phases of 1 to 6 months, the CBCR group showed a greater cardiac output improvement than the HBCR group.


Assuntos
Biomarcadores/sangue , Reabilitação Cardíaca , Doenças Cardiovasculares , Terapia por Exercício , Serviços de Assistência Domiciliar/estatística & dados numéricos , Centros de Reabilitação/estatística & dados numéricos , Reabilitação Cardíaca/métodos , Reabilitação Cardíaca/normas , Doenças Cardiovasculares/sangue , Doenças Cardiovasculares/diagnóstico , Doenças Cardiovasculares/fisiopatologia , Doenças Cardiovasculares/terapia , Pesquisa Comparativa da Efetividade , Teste de Esforço/métodos , Terapia por Exercício/métodos , Terapia por Exercício/organização & administração , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Avaliação de Processos e Resultados em Cuidados de Saúde , República da Coreia/epidemiologia , Testes de Função Respiratória/métodos , Testes de Função Respiratória/estatística & dados numéricos , Resultado do Tratamento
7.
J Am Heart Assoc ; 10(16): e021144, 2021 08 17.
Artigo em Inglês | MEDLINE | ID: mdl-34387130

RESUMO

Background Optimal management of asymptomatic Brugada syndrome (BrS) with spontaneous type I electrocardiographic pattern is uncertain. Methods and Results We developed an individual-level simulation comprising 2 000 000 average-risk individuals with asymptomatic BrS and spontaneous type I electrocardiographic pattern. We compared (1) observation, (2) electrophysiologic study (EPS)-guided implantable cardioverter-defibrillator (ICD), and (3) upfront ICD, each using either subcutaneous or transvenous ICD, resulting in 6 strategies tested. The primary outcome was quality-adjusted life years (QALYs), with cardiac deaths (arrest or procedural-related) as a secondary outcome. We varied BrS diagnosis age and underlying arrest rate. We assessed cost-effectiveness at $100 000/QALY. Compared with observation, EPS-guided subcutaneous ICD resulted in 0.35 QALY gain/individual and 4130 cardiac deaths avoided/100 000 individuals, and EPS-guided transvenous ICD resulted in 0.26 QALY gain and 3390 cardiac deaths avoided. Compared with observation, upfront ICD reduced cardiac deaths by a greater margin (subcutaneous ICD, 8950; transvenous ICD, 6050), but only subcutaneous ICD improved QALYs (subcutaneous ICD, 0.25 QALY gain; transvenous ICD, 0.01 QALY loss), and complications were higher. ICD-based strategies were more effective at younger ages and higher arrest rates (eg, using subcutaneous devices, upfront ICD was the most effective strategy at ages 20-39.4 years and arrest rates >1.37%/year; EPS-guided ICD was the most effective strategy at ages 39.5-51.3 years and arrest rates 0.47%-1.37%/year, and observation was the most effective strategy at ages >51.3 years and arrest rates <0.47%/year). EPS-guided subcutaneous ICD was cost-effective ($80 508/QALY). Conclusions Device-based approaches (with or without EPS risk stratification) can be more effective than observation among selected patients with asymptomatic BrS. BrS management should be tailored to patient characteristics.


Assuntos
Síndrome de Brugada/terapia , Técnicas de Apoio para a Decisão , Desfibriladores Implantáveis , Cardioversão Elétrica/instrumentação , Adulto , Doenças Assintomáticas , Síndrome de Brugada/diagnóstico , Síndrome de Brugada/economia , Síndrome de Brugada/mortalidade , Pesquisa Comparativa da Efetividade , Análise Custo-Benefício , Desfibriladores Implantáveis/economia , Cardioversão Elétrica/efeitos adversos , Cardioversão Elétrica/economia , Cardioversão Elétrica/mortalidade , Eletrocardiografia , Custos de Cuidados de Saúde , Humanos , Pessoa de Meia-Idade , Modelos Econômicos , Anos de Vida Ajustados por Qualidade de Vida , Recuperação de Função Fisiológica , Fatores de Tempo , Resultado do Tratamento
10.
Am J Psychiatry ; 178(10): 932-940, 2021 10 01.
Artigo em Inglês | MEDLINE | ID: mdl-34256606

RESUMO

OBJECTIVE: Effectiveness of antipsychotic drugs is inferred from relatively small randomized clinical trials conducted with carefully selected and monitored participants. This evidence is not necessarily generalizable to individuals treated in daily clinical practice. The authors compared the clinical effectiveness between all oral and long-acting injectable (LAI) antipsychotic medications used in the treatment of schizophrenia in the U.S. Department of Veterans Affairs (VA) health care system. METHODS: This was an observational study utilizing VA pharmacy data from 37,368 outpatient veterans with schizophrenia. Outcome measures were all-cause antipsychotic discontinuation and psychiatric hospitalizations. Oral olanzapine was used as the reference group. RESULTS: In multivariable analysis, clozapine (hazard ratio=0.43), aripiprazole long-acting injectable (LAI) (hazard ratio=0.71), paliperidone LAI (hazard ratio=0.76), antipsychotic polypharmacy (hazard ratio=0.77), and risperidone LAI (hazard ratio=0.91) were associated with reduced hazard of discontinuation compared with oral olanzapine. Oral first-generation antipsychotics (hazard ratio=1.16), oral risperidone (hazard ratio=1.15), oral aripiprazole (hazard ratio=1.14), oral ziprasidone (hazard ratio=1.13), and oral quetiapine (hazard ratio=1.11) were significantly associated with an increased risk of discontinuation compared with oral olanzapine. No treatment showed reduced risk of psychiatric hospitalization compared with oral olanzapine; quetiapine was associated with a 36% worse outcome in terms of hospitalizations compared with olanzapine. CONCLUSIONS: In a national sample of veterans with schizophrenia, those treated with clozapine, two of the LAI second-generation antipsychotics, and antipsychotic polypharmacy continued the same antipsychotic therapy for a longer period of time compared with the reference drug. This may reflect greater overall acceptability of these medications in clinical practice.


Assuntos
Antipsicóticos , Hospitalização/estatística & dados numéricos , Pacientes Ambulatoriais/estatística & dados numéricos , Esquizofrenia , Veteranos , Administração Oral , Antipsicóticos/classificação , Antipsicóticos/uso terapêutico , Pesquisa Comparativa da Efetividade , Preparações de Ação Retardada/uso terapêutico , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Avaliação de Resultados em Cuidados de Saúde , Esquizofrenia/diagnóstico , Esquizofrenia/epidemiologia , Esquizofrenia/terapia , Resultado do Tratamento , Estados Unidos/epidemiologia , United States Department of Veterans Affairs/estatística & dados numéricos , Veteranos/psicologia , Veteranos/estatística & dados numéricos , Suspensão de Tratamento/estatística & dados numéricos
11.
JAMA Otolaryngol Head Neck Surg ; 147(9): 797-803, 2021 09 01.
Artigo em Inglês | MEDLINE | ID: mdl-34292321

RESUMO

Importance: During respiratory disease outbreaks such as the COVID-19 pandemic, aerosol-generating procedures, including tracheostomy, are associated with the risk of viral transmission to health care workers. Objective: To quantify particle aerosolization during tracheostomy surgery and tracheostomy care and to evaluate interventions that minimize the risk of viral particle exposure. Design, Setting, and Participants: This comparative effectiveness study was conducted from August 2020 to January 2021 at a tertiary care academic institution. Aerosol generation was measured in real time with an optical particle counter during simulated (manikin) tracheostomy surgical and clinical conditions, including cough, airway nebulization, open suctioning, and electrocautery. Aerosol sampling was also performed during in vivo swine tracheostomy procedures (n = 4), with or without electrocautery. Fluorescent dye was used to visualize cough spread onto the surgical field during swine tracheostomy. Finally, 6 tracheostomy coverings were compared with no tracheostomy covering to quantify reduction in particle aerosolization. Main Outcomes and Measures: Respirable aerosolized particle concentration. Results: Cough, airway humidification, open suctioning, and electrocautery produced aerosol particles substantially above baseline. Compared with uncovered tracheostomy, decreased aerosolization was found with the use of tracheostomy coverings, including a cotton mask (73.8% [(95% CI, 63.0%-84.5%]; d = 3.8), polyester gaiter 79.5% [95% CI, 68.7%-90.3%]; d = 7.2), humidification mask (82.8% [95% CI, 72.0%-93.7%]; d = 8.6), heat moisture exchanger (HME) (91.0% [95% CI, 80.2%-101.7%]; d = 19.0), and surgical mask (89.9% [95% CI, 79.3%-100.6%]; d = 12.8). Simultaneous use of a surgical mask and HME decreased the particle concentration compared with either the HME (95% CI, 1.6%-12.3%; Cohen d = 1.2) or surgical mask (95% CI, 2.7%-13.2%; d = 1.9) used independently. Procedures performed with electrocautery increased total aerosolized particles by 1500 particles/m3 per 5-second interval (95% CI, 1380-1610 particles/m3 per 5-second interval; d = 1.8). Conclusions and Relevance: The findings of this laboratory and animal comparative effectiveness study indicate that tracheostomy surgery and tracheostomy care are associated with significant aerosol generation, putting health care workers at risk for viral transmission of airborne diseases. Combined HME and surgical mask coverage of the tracheostomy was associated with decreased aerosolization, thereby reducing the risk of viral transmission to health care workers.


Assuntos
Aerossóis , Controle de Infecções/métodos , Transmissão de Doença Infecciosa do Paciente para o Profissional/prevenção & controle , Corpo Clínico Hospitalar , Traqueostomia/efeitos adversos , Vírion , Animais , COVID-19/prevenção & controle , COVID-19/transmissão , Pesquisa Comparativa da Efetividade , Eletrocoagulação/efeitos adversos , Temperatura Alta , Humanos , Umidade , Manequins , Máscaras , Fatores de Risco , SARS-CoV-2 , Suínos , Traqueostomia/instrumentação
13.
Res Synth Methods ; 12(6): 750-775, 2021 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-34196111

RESUMO

Population-adjusted indirect comparisons estimate treatment effects when access to individual patient data is limited and there are cross-trial differences in effect modifiers. Popular methods include matching-adjusted indirect comparison (MAIC) and simulated treatment comparison (STC). There is limited formal evaluation of these methods and whether they can be used to accurately compare treatments. Thus, we undertake a comprehensive simulation study to compare standard unadjusted indirect comparisons, MAIC and STC across 162 scenarios. This simulation study assumes that the trials are investigating survival outcomes and measure continuous covariates, with the log hazard ratio as the measure of effect. MAIC yields unbiased treatment effect estimates under no failures of assumptions. The typical usage of STC produces bias because it targets a conditional treatment effect where the target estimand should be a marginal treatment effect. The incompatibility of estimates in the indirect comparison leads to bias as the measure of effect is non-collapsible. Standard indirect comparisons are systematically biased, particularly under stronger covariate imbalance and interaction effects. Standard errors and coverage rates are often valid in MAIC but the robust sandwich variance estimator underestimates variability where effective sample sizes are small. Interval estimates for the standard indirect comparison are too narrow and STC suffers from bias-induced undercoverage. MAIC provides the most accurate estimates and, with lower degrees of covariate overlap, its bias reduction outweighs the loss in precision under no failures of assumptions. An important future objective is the development of an alternative formulation to STC that targets a marginal treatment effect.


Assuntos
Pesquisa Comparativa da Efetividade , Viés , Simulação por Computador , Humanos , Tamanho da Amostra
14.
Med Care ; 59(Suppl 4): S330-S335, 2021 08 01.
Artigo em Inglês | MEDLINE | ID: mdl-34228014

RESUMO

BACKGROUND: This Special Issue, Future Directions in Transitional Care Research, focuses on the approaches used and lessons learned by researchers conducting care transitions studies funded by the Patient-Centered Outcomes Research Institute (PCORI). PCORI's approach to transitional care research augments prior research by encouraging researchers to focus on head-to-head comparisons of interventions, the use of patient-centered outcomes, and the engagement of stakeholders throughout the research process. OBJECTIVES: This paper introduces the themes and topics addressed by the articles that follow, which are focused on opportunities and challenges involved in conducting patient-centered clinical comparative effectiveness research in transitional care. It provides an overview of the state of the care transitions field, a description of PCORI's programmatic objectives, highlights of the patient and stakeholder engagement activities that have taken place during the course of these studies, and a brief overview of PCORI's Transitional Care Evidence to Action Network, a learning community designed to foster collaboration between investigators and their research teams and enhance the collective impact of this body of work. CONCLUSIONS: The papers in this Special Issue articulate challenges, lessons learned, and new directions for measurement, stakeholder engagement, implementation, and methodological and design approaches that reflect the complexity of transitional care comparative effectiveness research and seek to move the field toward a more holistic understanding of transitional care that integrates social needs and lifespan development into our approaches to improving care transitions.


Assuntos
Pesquisa Comparativa da Efetividade , Pesquisa sobre Serviços de Saúde , Avaliação de Resultados da Assistência ao Paciente , Assistência Centrada no Paciente , Cuidado Transicional , Academias e Institutos , Humanos , Ciência da Implementação
15.
Med Care ; 59(Suppl 4): S379-S386, 2021 08 01.
Artigo em Inglês | MEDLINE | ID: mdl-34228020

RESUMO

BACKGROUND: The expedient translation of research findings into sustainable intervention procedures is a longstanding health care system priority. The Patient-Centered Outcomes Research Institute (PCORI) has facilitated the development of "research done differently," with a central tenet that key stakeholders can be productively engaged throughout the research process. Literature review revealed few examples of whether, as originally posited, PCORI's innovative stakeholder-driven approach could catalyze the expedient translation of research results into practice. OBJECTIVES: This narrative review traces the historical development of an American College of Surgeons Committee on Trauma (ACS/COT) policy guidance, facilitated by evidence supplied by the PCORI-funded studies evaluating the delivery of patient-centered care transitions. Key elements catalyzing the guidance are reviewed, including the sustained engagement of ACS/COT policy stakeholders who have the capacity to invoke system-level implementation strategies, such as regulatory mandates linked to verification site visits. Other key elements, including the encouragement of patient stakeholder voice in policy decisions and the incorporation of end-of-study policy summits in pragmatic comparative effectiveness trial design, are discussed. CONCLUSIONS: Informed by comparative effectiveness trials, ACS/COT policy has expedited introduction of the patient-centered care construct into US trauma care systems. A comparative health care systems conceptual framework for transitional care which incorporates Research Lifecycle, pragmatic clinical trial and implementation science models is articulated. When combined with Rapid Assessment Procedure Informed Clinical Ethnography (RAPICE), employed as a targeted implementation strategy, this approach may accelerate the sustainable delivery of high-quality patient-centered care transitions for US trauma care systems.


Assuntos
Serviços Médicos de Emergência , Implementação de Plano de Saúde/métodos , Avaliação de Resultados da Assistência ao Paciente , Cuidado Transicional , Pesquisa Médica Translacional/métodos , Pesquisa Comparativa da Efetividade , Atenção à Saúde , Política de Saúde , Humanos , Assistência Centrada no Paciente , Participação dos Interessados , Estados Unidos
16.
Neurology ; 97(7): e720-e727, 2021 08 17.
Artigo em Inglês | MEDLINE | ID: mdl-34187862

RESUMO

OBJECTIVE: To investigate whether receiving a second-line anticonvulsant medication that is part of a patient's home regimen influences outcomes in benzodiazepine-refractory convulsive status epilepticus. METHODS: Using the Established Status Epilepticus Treatment Trial data, allocation to a study drug included in the patient's home anticonvulsant medication regimen was compared to receipt of an alternative second-line study medication. The primary outcome was cessation of clinical seizures with improved consciousness by 60 minutes after study drug initiation. Secondary outcomes were seizure cessation adjudicated from medical records and adverse events. We performed inverse probability of treatment-weighted (IPTW) logistic regressions. RESULTS: Of 462 patients, 232 (50%) were taking 1-2 of the 3 study medications at home. The primary outcome was observed in 39/89 (44%) patients allocated to their home medication vs 76/143 (53%) allocated to a nonhome medication (IPTW odds ratio [OR] 0.66, 95% confidence interval [CI] 0.39-1.14). The adjudicated outcome occurred in 37/89 (42%) patients vs 82/143 (57%), respectively (IPTW OR 0.52, 95% CI 0.30-0.89). There was no interaction between study levetiracetam and home levetiracetam and there were no differences in adverse events. CONCLUSION: There was no difference in the primary outcome for patients who received a home medication vs nonhome medication. However, the retrospective evaluation suggested an association between receiving a nonhome medication and seizure cessation. CLASSIFICATION OF EVIDENCE: This study provides Class II evidence that for patients with refractory convulsive status epilepticus, use of a home second-line anticonvulsant compared to a nonhome anticonvulsant did not significantly affect the probability of stopping seizures.


Assuntos
Anticonvulsivantes/farmacologia , Epilepsia Resistente a Medicamentos/tratamento farmacológico , Levetiracetam/farmacologia , Avaliação de Resultados em Cuidados de Saúde , Estado Epiléptico/tratamento farmacológico , Adolescente , Adulto , Anticonvulsivantes/administração & dosagem , Anticonvulsivantes/efeitos adversos , Benzodiazepinas/farmacologia , Criança , Pesquisa Comparativa da Efetividade , Método Duplo-Cego , Quimioterapia Combinada , Feminino , Humanos , Levetiracetam/administração & dosagem , Levetiracetam/efeitos adversos , Masculino , Pessoa de Meia-Idade , Fenitoína/farmacologia , Autoadministração , Ácido Valproico/farmacologia , Adulto Jovem
17.
Isr Med Assoc J ; 23(6): 344-349, 2021 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-34155846

RESUMO

BACKGROUND: There is a lack of real-life clinical data for biosimilar etanercept, an anti-TNF blocking fusion protein. We describe the comparable efficacy and safety of originator and biosimilar etanercept in rheumatoid arthritis (RA) patients in a real-life clinical setting. Our data confirm that a biosimilar etanercept can be safely used as first-line treatment as well as in patients switched from a previous originator compound. OBJECTIVES: To compare the efficacy and safety of originator and biosimilar etanercept in a cohort of RA patients attending two Italian hospitals. METHODS: The study involved 81 consecutive adult RA patients treated for at least 6 months with originator or biosimilar etanercept and considered their clinical and laboratory data, concomitant medications, and adverse events at baseline, and after 3 and 6 months of treatment. RESULTS: Group 1 included 51 patients taking originator etanercept; group 2 included 30 taking biosimilar etanercept, including 19 who had been switched from the reference product. Despite a significant baseline difference in clinical disease activity, one-way analysis of variance showed that the two groups were clinically comparable after 6 months of treatment, and the same was true when only those receiving etanercept as first-line biological treatment were considered. Nine patients discontinued the treatment due to inefficacy or adverse events, which were never serious and were only reported in group 1. CONCLUSIONS: The efficacy and safety profiles of originator and biosimilar etanercept are comparable in RA patients in a real-life clinical setting. Further studies are needed to confirm these preliminary findings.


Assuntos
Artrite Reumatoide , Medicamentos Biossimilares , Substituição de Medicamentos/métodos , Etanercepte , Preferência do Paciente , Antirreumáticos/administração & dosagem , Antirreumáticos/efeitos adversos , Artrite Reumatoide/sangue , Artrite Reumatoide/diagnóstico , Artrite Reumatoide/tratamento farmacológico , Medicamentos Biossimilares/administração & dosagem , Medicamentos Biossimilares/efeitos adversos , Sedimentação Sanguínea/efeitos dos fármacos , Proteína C-Reativa/análise , Pesquisa Comparativa da Efetividade , Análise Custo-Benefício , Monitoramento de Medicamentos/métodos , Etanercepte/administração & dosagem , Etanercepte/efeitos adversos , Feminino , Humanos , Itália , Masculino , Pessoa de Meia-Idade , Avaliação de Processos e Resultados em Cuidados de Saúde , Gravidade do Paciente , Segurança do Paciente , Resultado do Tratamento
18.
JAMA Netw Open ; 4(6): e2115985, 2021 06 01.
Artigo em Inglês | MEDLINE | ID: mdl-34097044

RESUMO

Importance: The BNT162b2 vaccine showed high efficacy against COVID-19 in a phase III randomized clinical trial. A vaccine effectiveness evaluation in a real-world setting is needed. Objective: To assess the short-term effectiveness of the first dose of the BNT162b2-vaccine against SARS-CoV-2 infection 13 to 24 days after immunization in a real-world setting. Design, Setting, and Participants: This comparative effectiveness study used data from a 2.6 million-member state-mandated health care system in Israel. Participants included all individuals aged 16 years and older who received 1 dose of the BNT162b2 vaccine between December 19, 2020, and January 15, 2021. Data were analyzed in March 2021. Exposure: Receipt of 1 dose of the BNT162b2 vaccine. Main Outcomes and Measures: Information was collected regarding medical history and positive SARS-CoV-2 polymerase chain reaction test and COVID-19 symptoms from 1 day after first vaccine to January 17, 2021. Daily and cumulative infection rates in days 13 to 24 were compared with days 1 to 12 after the first dose using Kaplan-Meier survival analysis and generalized linear models. Results: Data for 503 875 individuals (mean [SD] age, 59.7 [14.7] years; 263 228 [52.4%] women) were analyzed, of whom 351 897 had follow-up data for days 13 to 24. The cumulative incidence of SARS-CoV-2 infection was 2484 individuals (0.57%) during days 1 through 12 and 614 individuals (0.27%) in days 13 through 24. The weighted mean (SE) daily incidence of SARS-CoV-2 infection in days 1 through 12 was 43.41 (12.07) infections per 100 000 population and 21.08 (6.16) infections per 100 000 population in days 13 through 24, a relative risk reduction (RRR) of 51.4% (95% CI, 16.3%-71.8%). The decrease in incidence was evident from day 18 after the first dose. Similar RRRs were calculated in individuals aged 60 years or older (44.5%; 95% CI, 4.1%-67.9%), those younger than 60 years (50.2%; 95% CI, 14.1%-71.2%), women (50.0%; 95% CI, 13.5%-71.0%), and men (52.1%; 95% CI, 17.3%-72.2%). Findings were similar in subpopulations (eg, ultraorthodox Jewish: RRR, 53.5% [95% CI, 19.2%-73.2%]) and patients with various comorbidities (eg, cardiovascular diseases: RRR, 47.2% [95% CI, 7.8%-69.8%]). Vaccine effectiveness against symptomatic COVID-19 was 54.4% (95% CI, 21.4%-73.6%). Conclusions and Relevance: In this comparative effectiveness study of a single dose of the BNT162b2 vaccine, results were comparable to that of the phase III randomized clinical trial.


Assuntos
Vacinas contra COVID-19 , COVID-19/prevenção & controle , Vacinação , Idoso , Pesquisa Comparativa da Efetividade , Feminino , Humanos , Imunização , Incidência , Israel , Masculino , Pessoa de Meia-Idade , SARS-CoV-2 , Fatores de Tempo , Resultado do Tratamento
19.
Am J Gastroenterol ; 116(6): 1304-1312, 2021 06 01.
Artigo em Inglês | MEDLINE | ID: mdl-34074830

RESUMO

INTRODUCTION: Psyllium and prunes are proven treatments for chronic constipation (CC). Asian studies suggest that kiwifruit may also benefit CC symptoms. We report a partially randomized, comparative effectiveness trial evaluating kiwifruit, psyllium, and prunes in US patients with CC. METHODS: Adults with CC at a US medical center were randomized to 3 natural treatments. Eligible patients had ≤3 complete spontaneous bowel movements (CSBMs) per week and were partially randomized to green kiwifruit (2/d), prunes (100 g/d), or psyllium (12 g/d) for 4 weeks. The primary endpoint was the proportion of patients in each group reporting an increase of ≥1 CSBM per week compared with baseline for at least 2 of 4 treatment weeks. Key secondary outcomes included stool frequency, stool consistency, and straining assessed daily. Treatment satisfaction and adverse events (AEs) were also measured. Standard statistical methods were used, and a P < 0.05 was considered significant. RESULTS: Seventy-nine patients with CC (mean age = 42.7 years, 87% female, and 77% white) were partially randomized. Complete data were available for 75 patients (kiwifruit 29, prunes 24, and psyllium 22). For the primary endpoint, proportions of CSBM responders were similar for the treatments. For secondary outcomes comparing treatment weeks 3 and 4 to baseline, there was a significant increase in weekly CSBM rate with all 3 treatments (P ≤ 0.003); stool consistency significantly improved with kiwifruit (P = 0.01) and prunes (P = 0.049); and straining significantly improved with kiwifruit (P = 0.003), prunes (P < 0.001), and psyllium (P = 0.04). Patients randomized to the kiwifruit group reported significant improvement in bloating scores (P = 0.02). AEs were most common with psyllium and least common with kiwifruit. At the end of treatment, a smaller proportion of patients were dissatisfied with kiwifruit compared with prunes or psyllium (P = 0.02). DISCUSSION: Kiwifruit, prunes, and psyllium improve constipation symptoms in patients with CC. Kiwifruit was associated with the lowest rate of AEs and dissatisfaction with therapy.


Assuntos
Constipação Intestinal/dietoterapia , Frutas , Psyllium/uso terapêutico , Actinidia , Adulto , Doença Crônica , Pesquisa Comparativa da Efetividade , Feminino , Humanos , Masculino , Prunus
20.
J Comp Eff Res ; 10(11): 939-951, 2021 08.
Artigo em Inglês | MEDLINE | ID: mdl-34060903

RESUMO

Aim & methods: We compared propensity score matching (PSM) and coarsened exact matching (CEM) in balancing baseline characteristics between treatment groups using observational data obtained from a pan-Canadian prostate cancer radiotherapy database. Changes in effect estimates were evaluated as a function of improvements in balance, using results from randomized clinical trials to guide interpretation. Results: CEM and PSM improved balance between groups in both comparisons, while retaining the majority of original data. Improvements in balance were associated with effect estimates closer to those obtained in randomized clinical trials. Conclusion: CEM and PSM led to substantial improvements in balance between comparison groups, while retaining a considerable proportion of original data. This could lead to improved accuracy in effect estimates obtained using observational data in a variety of clinical situations.


Assuntos
Pesquisa Comparativa da Efetividade , Canadá , Bases de Dados Factuais , Humanos , Masculino , Pontuação de Propensão
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