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1.
JAMA Netw Open ; 7(7): e2419873, 2024 Jul 01.
Artigo em Inglês | MEDLINE | ID: mdl-39023895

RESUMO

Importance: Endothelin receptor antagonists are first-line therapy for pulmonary arterial hypertension (PAH). The first 2 agents approved in the class, bosentan and ambrisentan, initially carried boxed warnings for hepatotoxicity and required monthly liver function tests (LFTs) as part of a risk evaluation and mitigation strategy (REMS); however, in 2011, as further safety data emerged on ambrisentan, the boxed hepatotoxicity warning and LFT requirements were removed. Objective: To analyze changes in the use of and LFT monitoring for ambrisentan and bosentan after changes to the ambrisentan labeling and REMS. Design, Setting, and Participants: This serial cross-sectional study used data from 3 longitudinal health care insurance claims databases-Medicaid, Optum's deidentified Clinformatics Data Mart, and Merative Marketscan-to perform an interrupted time series analysis of prescription fills and LFTs for patients taking ambrisentan and bosentan. Participants were patients filling prescriptions for ambrisentan and bosentan from July 1, 2007, to December 31, 2018. Data analysis was performed from April 2021 to August 2023. Exposure: Removal of the boxed warning for hepatotoxicity and the REMS LFT monitoring requirements on ambrisentan in March 2011. Main Outcomes and Measures: The primary outcomes were use of ambrisentan (ie, individuals with at least 1 dispensing per 1 000 000 individuals enrolled in the 3 datasets) vs bosentan and LFT monitoring (ie, proportion of initiators with at least 1 ordered test) before initiation and before the first refill. Results: A total of 10 261 patients received a prescription for ambrisentan during the study period (7442 women [72.5%]; mean [SD] age, 52.6 [17.6] years), and 11 159 patients received a prescription for bosentan (7931 women [71.1%]; mean [SD] age, 47.7 [23.7] years). Removal of the ambrisentan boxed hepatotoxicity warning and LFT monitoring requirement was associated with an immediate increase in the use of ambrisentan (1.50 patients per million enrollees; 95% CI, 1.08 to 1.92 patients per million enrollees) but no significant change in the use of bosentan. There were reductions in recorded LFTs before drug initiation (13.1% absolute decrease; 95% CI, -18.2% to -8.0%) and before the first refill (26.4% absolute decrease; 95% CI, -34.4% to -18.5%) of ambrisentan but not bosentan. Conclusions and Relevance: In this serial cross-sectional study of ambrisentan, labeling changes and removal of the REMS-related LFT requirement were associated with shifts in prescribing and testing behavior for ambrisentan but not bosentan. Further clinician education may be needed to maximize the benefits of REMS programs and labeling warnings designed to ensure the safe administration of high-risk medications.


Assuntos
Bosentana , Doença Hepática Induzida por Substâncias e Drogas , Testes de Função Hepática , Fenilpropionatos , Piridazinas , Humanos , Fenilpropionatos/uso terapêutico , Fenilpropionatos/efeitos adversos , Piridazinas/efeitos adversos , Piridazinas/uso terapêutico , Feminino , Masculino , Pessoa de Meia-Idade , Estudos Transversais , Testes de Função Hepática/métodos , Testes de Função Hepática/estatística & dados numéricos , Estados Unidos , Bosentana/uso terapêutico , Adulto , Rotulagem de Medicamentos/normas , United States Food and Drug Administration , Anti-Hipertensivos/efeitos adversos , Anti-Hipertensivos/uso terapêutico , Idoso , Antagonistas dos Receptores de Endotelina/uso terapêutico , Hipertensão Pulmonar/tratamento farmacológico
2.
BMJ ; 379: e069931, 2022 10 04.
Artigo em Inglês | MEDLINE | ID: mdl-36195324

RESUMO

OBJECTIVE: To evaluate the association between initiation of fluoroquinolones and hospital admission or emergency department visit for suicidality. DESIGN: Population based cohort study. SETTING: IBM MarketScan database, USA. PARTICIPANTS: 2 756 268 adults (≥18 years) who initiated an oral fluoroquinolone (ciprofloxacin, levofloxacin, moxifloxacin, gemifloxacin, ofloxacin, gatifloxacin, norfloxacin, lomefloxacin, besifloxacin) or comparator antibiotic (January 2003 to September 2015) and had at least six months of continuous health plan enrollment and a diagnosis of pneumonia or urinary tract infection (UTI) three days or less before the drug initiation date. Comparator antibiotics were azithromycin in the pneumonia cohort and trimethoprim-sulfamethoxazole in the UTI cohort. Participants were matched 1:1 within each cohort on a propensity score, calculated from a multivariable logistic regression model that included 57 baseline covariates. MAIN OUTCOMES MEASURE: Primary outcome was hospital admission or emergency department visit for suicidal ideation or self-harm within 60 days after treatment initiation. Cox proportional hazard models were used to estimate hazard ratios and 95% confidence intervals. RESULTS: The pneumonia cohort included 551 042 individuals, and the UTI cohort included 2 205 526 individuals. During the 60 day follow-up, 181 events were observed in the pneumonia cohort and 966 in the UTI cohort. The adjusted hazard ratios for fluoroquinolones were 1.01 (95% confidence interval 0.76 to 1.36) versus azithromycin in the pneumonia cohort and 1.03 (0.91 to 1.17) versus trimethoprim-sulfamethoxazole in the UTI cohort. Results were consistent across sensitivity analyses and subgroups of sex, age, or history of mental illnesses. CONCLUSION: Initiation of fluoroquinolones was not associated with a substantially increased risk of admission to hospital or emergency department visits for suicidality compared with azithromycin or trimethoprim-sulfamethoxazole.


Assuntos
Suicídio , Infecções Urinárias , Adulto , Antibacterianos/uso terapêutico , Azitromicina/uso terapêutico , Ciprofloxacina/uso terapêutico , Estudos de Coortes , Serviço Hospitalar de Emergência , Fluoroquinolonas/uso terapêutico , Gatifloxacina/uso terapêutico , Gemifloxacina , Hospitais , Humanos , Levofloxacino/efeitos adversos , Moxifloxacina/uso terapêutico , Norfloxacino/uso terapêutico , Estudos Retrospectivos , Ideação Suicida , Combinação Trimetoprima e Sulfametoxazol , Infecções Urinárias/tratamento farmacológico
3.
Reprod Health ; 18(1): 215, 2021 Oct 30.
Artigo em Inglês | MEDLINE | ID: mdl-34717686

RESUMO

BACKGROUND: In low-and-middle income countries (LMICs), accurate measures of the elements of quality care provided by a health worker through family planning services (also known as process quality) are required to ensure family's contraceptives needs are being met. There are many tools used to assess family planning process quality of care (QoC) but no one standardized method. Those measuring QoC in LMICs should select an appropriate tool based the program context and financial/logistical parameters, but they require data on how well each tool measures routine clinical care. We aim to synthesize the literature on validity/comparability of family planning process QoC measurement tools through a quantitative systematic review with no meta-analysis. METHODS: We searched six literature databases for studies that compared quality measurements from different tools using quantitative statistics such as sensitivity/specificity, kappa statistic or absolute difference. We extracted the comparative measure along with other relevant study information, organized by quality indicator domain (e.g. counseling and privacy), and then classified the measure by low, medium, and high agreement. RESULTS: We screened 8172 articles and identified eight for analysis. Studies comparing quality measurements from simulated clients, direct observation, client exit interview, provider knowledge quizzes, and medical record review were included. These eight studies were heterogenous in their methods and the measurements compared. There was insufficient data to estimate overall summary measures of validity for the tools. Client exit interviews compared to direct observation or simulated client protocols had the most data and they were a poor proxy of the actual quality care received for many measurements. CONCLUSION: To measure QoC consistently and accurately in LMICs, standardized tools and measures are needed along with an established method of combining them for a comprehensive picture of quality care. Data on how different tools proxy quality client care will inform these guidelines. Despite the small number of studies found during the review, we described important differences on how tools measure quality of care.


Accurate measures of process quality of care­or how well clinicians deliver services according to standards of care­are important to monitor, evaluate and improve service quality. Periodic surveys of health facilities or provider are the main source of national or regional quality of care data in many low- and middle-income countries. Many tools are used for these surveys: exit interviews with patients, observations of the visits by a clinician-assessor, simulated or mystery patients, and others. Implementers must select the appropriate and feasible tools for their program, context and setting but there is little information on how well different tools measure the same quality of care indicators.This review summarizes the current literature on the validity of measurements from different family planning quality of care tools. We found only eight studies, but we were able to see some differences important to consider when selecting the most appropriate tool. For instance, patients reported different events through an exit interview than what was documented by the assessor during the same visit. Exit interviews may be more appropriate to measure client experience or satisfaction rather than specifics of the care received. Knowing these differences will help implementers choose an appropriate tool depending on the focus of the quality assessment. This review contributes to the body of knowledge on improving quality of care measurements, resulting in better data to improve family planning services for patients.


Assuntos
Serviços de Planejamento Familiar , Qualidade da Assistência à Saúde , Aconselhamento , Atenção à Saúde , Humanos
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