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1.
J Pediatr Intensive Care ; 13(2): 201-208, 2024 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-38919693

RESUMO

This study aimed to create a pediatric sedation scoring system independent of the American Society of Anesthesiology Physical Status (ASA-PS) classification that is predictive of adverse events, facilitates objective stratification, and resource allocation. Multivariable regression and machine learning algorithm analysis of 134,973 sedation encounters logged in to the Pediatric Sedation Research Consortium (PSRC) database between July 2007 and June 2011. Patient and procedure variables were correlated with adverse events with resultant ß -regression coefficients used to assign point values to each variable. Point values were then summed to create a risk assessment score. Validation of the model was performed with the 2011 to 2013 PSRC database followed by calculation of ROC curves and positive predictive values. Factors identified and resultant point values are as follows: 1 point: age ≤ 6 months, cardiac diagnosis, asthma, weight less than 5th percentile or greater than 95 th , and computed tomography (CT) scan; 2 points: magnetic resonance cholangiopancreatography (MRCP) and weight greater than 99th percentile; 4 points: magnetic resonance imaging (MRI); 5 points: trisomy 21 and esophagogastroduodenoscopy (EGD); 7 points: cough at the time of examination; and 18 points: bronchoscopy. Sum of patient and procedural values produced total risk assessment scores. Total risk assessment score of 5 had a sensitivity of 82.69% and a specificity of 26.22%, while risk assessment score of 11 had a sensitivity of 12.70% but a specificity of 95.29%. Inclusion of ASA-PS value did not improve model sensitivity or specificity and was thus excluded. Higher risk assessment scores predicted increased likelihood of adverse events during sedation. The score can be used to triage patients independent of ASA-PS with site-specific cut-off values used to determine appropriate sedation resource allocation.

2.
J Thorac Dis ; 16(5): 2983-2993, 2024 May 31.
Artigo em Inglês | MEDLINE | ID: mdl-38883686

RESUMO

Background: Coronavirus disease 2019 (COVID-19), a disease that affected tens of millions of people, upended the lives of countless individuals around the globe. The chloroquine (CQ) and its analogue hydroxychloroquine (HCQ) were the most frequently cited as potential treatments and preventatives against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The primary aim of this investigation was to scrutinize the effectiveness and safety of HCQ for COVID-19 prevention and to present powerful evidence and reference for clinical practice. Methods: PubMed, Ovid and the Cochrane COVID-19 Register of Controlled Trials (CENTRAL) were systematically searched from inception to January 31, 2022. Randomized controlled trials (RCTs) trials that included participants who were SARS-CoV-2 negative at the time of registration were enrolled in this meta-analysis. The intervention group took HCQ or CQ orally. The control group was not blinded by quinine or placebo. Pooled relative risk (RR) of SARS-CoV-2 infection, mortality, hospitalization, adverse events, and compliance were calculated. The software tools utilized for statistical analyses were Stata 14 and Review Manager 5.3. Results: A total of 9 studies including 7,825 participants were enrolled. Bias of individual studies were assessed as low risk. The pooled RR for SARS-CoV-2 infection was 0.75 [95% confidence interval (CI): 0.68-0.83] (z=-4.01, P<0.0001; I2=11%). The pooled RR for hospitalization was 0.72 (95% CI: 0.35-1.50) (z=0.87, P=0.39; I2=0.0%). The pooled RR for mortality and adverse events were 3.26 (95% CI: 0.13-79.74) (z=0.72, P=0.47; I2=0.0%) and 1.90 (95% CI: 1.20-3.02) (z=2.73, P=0.0063; I2=94%). Conclusions: Results of this meta-analysis indicated significant impact of HCQ on SARS-CoV-2 infection with higher risk of adverse events. These findings must be considered with caution, and further research is necessary to delineate the specific circumstances where HCQ may be effective for COVID-19 prevention.

4.
BMC Prim Care ; 25(1): 205, 2024 Jun 08.
Artigo em Inglês | MEDLINE | ID: mdl-38851666

RESUMO

BACKGROUND: Data on overuse of diagnostic and therapeutic resources underline their contribution to the decline in healthcare quality. The application of "Do Not Do" recommendations, in interaction with gender biases in primary care, remains to be fully understood. Therefore, this study aims to identify which low-value practices (LVPs) causing adverse events are susceptible to be applied in primary care setting with different frequency between men and women. METHODS: A consensus study was conducted between November 1, 2021, and July 4, 2022, in the primary care setting of the Valencian Community, Spain. Thirty-three of the 61 (54.1%) health professionals from clinical and research settings invited, completed the questionnaire. Participants were recruited by snowball sampling through two scientific societies, meeting specific inclusion criteria: over 10 years of professional experience and a minimum of 7 years focused on health studies from a gender perspective. An initial round using a questionnaire comprising 40 LVPs to assess consensus on their frequency in primary care, potential to cause serious adverse events, and different frequency between men and women possibly due to gender bias. A second round-questionnaire was administered to confirm the final selection of LVPs. RESULTS: This study identified nineteen LVPs potentially linked to serious adverse events with varying frequencies between men and women in primary care. Among the most gender-biased and harmful LVPs were the use of benzodiazepines for insomnia, delirium, and agitation in the elderly, and the use of hypnotics without a previous etiological diagnosis. CONCLUSIONS: Identifying specific practices with potential gender biases, mainly in mental health for the elderly, contributes to healthcare promotion and bridges the gap in gender inequalities. TRIAL REGISTRATION: NCT05233852, registered on 10 February 2022.


Assuntos
Atenção Primária à Saúde , Sexismo , Adulto , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Uso Excessivo dos Serviços de Saúde/prevenção & controle , Uso Excessivo dos Serviços de Saúde/estatística & dados numéricos , Qualidade da Assistência à Saúde , Espanha/epidemiologia , Inquéritos e Questionários
5.
Cancers (Basel) ; 16(11)2024 May 30.
Artigo em Inglês | MEDLINE | ID: mdl-38893187

RESUMO

The objective of this observational, single-center, retrospective study conducted in a Spanish tertiary hospital was to describe the real-world (RW) healthcare resource utilization (HCRU) among patients with advanced non-small-cell lung cancer (aNSCLC) who received chemotherapy (CT) or immunotherapy (IT) as first and second lines of treatment. A total of 173 patients diagnosed with aNSCLC and treated between January 2016 and August 2020 were included. The standardized average costs per patient/year were EUR 40,973.2 and EUR 22,502.4 for first-line CT and IT and EUR 140,601.3 and EUR 20,175.9 for second-line CT and IT, respectively. The average annual costs per patient associated with adverse-event (AE) onset were EUR 29,939.7 and EUR 460.7 for first-line CT and IT and EUR 35,906.4 and EUR 3206.1 for second-line CT and IT, respectively. The costs associated with disease management were EUR 33,178.0 and EUR 22,448.4 for first-line CT and IT and EUR 127,134.2 and EUR 19,663.9 for second-line CT and IT, respectively. In conclusion, IT use showed a lower average annual cost per patient, which was associated with lower HCRU for both disease and AE management, compared to the use of CT. However, these results should be further confirmed in the context of the currently implemented treatment schemes, including the combination of CT with single or dual IT.

6.
Trials ; 25(1): 353, 2024 May 31.
Artigo em Inglês | MEDLINE | ID: mdl-38822392

RESUMO

BACKGROUND: The SAVVY project aims to improve the analyses of adverse events (AEs) in clinical trials through the use of survival techniques appropriately dealing with varying follow-up times and competing events (CEs). This paper summarizes key features and conclusions from the various SAVVY papers. METHODS: Summarizing several papers reporting theoretical investigations using simulations and an empirical study including randomized clinical trials from several sponsor organizations, biases from ignoring varying follow-up times or CEs are investigated. The bias of commonly used estimators of the absolute (incidence proportion and one minus Kaplan-Meier) and relative (risk and hazard ratio) AE risk is quantified. Furthermore, we provide a cursory assessment of how pertinent guidelines for the analysis of safety data deal with the features of varying follow-up time and CEs. RESULTS: SAVVY finds that for both, avoiding bias and categorization of evidence with respect to treatment effect on AE risk into categories, the choice of the estimator is key and more important than features of the underlying data such as percentage of censoring, CEs, amount of follow-up, or value of the gold-standard. CONCLUSIONS: The choice of the estimator of the cumulative AE probability and the definition of CEs are crucial. Whenever varying follow-up times and/or CEs are present in the assessment of AEs, SAVVY recommends using the Aalen-Johansen estimator (AJE) with an appropriate definition of CEs to quantify AE risk. There is an urgent need to improve pertinent clinical trial reporting guidelines for reporting AEs so that incidence proportions or one minus Kaplan-Meier estimators are finally replaced by the AJE with appropriate definition of CEs.


Assuntos
Ensaios Clínicos Controlados Aleatórios como Assunto , Humanos , Fatores de Tempo , Ensaios Clínicos Controlados Aleatórios como Assunto/normas , Guias de Prática Clínica como Assunto , Interpretação Estatística de Dados , Medição de Risco , Projetos de Pesquisa/normas , Fatores de Risco , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Viés , Análise de Sobrevida , Seguimentos , Resultado do Tratamento , Simulação por Computador , Estimativa de Kaplan-Meier
7.
Am J Surg ; 234: 74-79, 2024 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-38719680

RESUMO

OBJECTIVES: This study aimed to investigate adverse events (AEs) in trauma resuscitation, evaluate contributing factors, and assess methods, such as trauma video review (TVR), to mitigate AEs. BACKGROUND: Trauma remains a leading cause of global mortality and morbidity, necessitating effective trauma care. Despite progress, AEs during trauma resuscitation persist, impacting patient outcomes and the healthcare system. Identifying and analyzing AEs and their determinants are crucial for improving trauma care. METHODS: This narrative review explored the definition, identification, and assessment of AEs associated with trauma resuscitation within the trauma system. It includes various studies and assessment tools such as STAT Taxonomy and T-NOTECHs. Additionally, it assessed the role of TVR in detecting AEs and strategies to enhance patient safety. CONCLUSION: Integrated with standardized tools, TVR shows promise for identifying AEs. Challenges include ensuring reporting consistency and integrating approaches into existing protocols. Future research should prioritize linking trauma team performance to patient outcomes, and develop sustainable TVR programs to enhance patient safety.


Assuntos
Segurança do Paciente , Ressuscitação , Gravação em Vídeo , Ferimentos e Lesões , Humanos , Ferimentos e Lesões/terapia , Ressuscitação/métodos , Erros Médicos/prevenção & controle , Centros de Traumatologia
8.
Vaccine ; 42(15): 3486-3492, 2024 May 31.
Artigo em Inglês | MEDLINE | ID: mdl-38704258

RESUMO

BACKGROUND: While safety of influenza vaccines is well-established, some studies have suggested potential associations between influenza vaccines and certain adverse events (AEs). This study examined the safety of the 2022-2023 influenza vaccines among U.S. adults ≥ 65 years. METHODS: A self-controlled case series compared incidence rates of anaphylaxis, encephalitis/encephalomyelitis, Guillain-Barré Syndrome (GBS), and transverse myelitis following 2022-2023 seasonal influenza vaccinations (i.e., any, high-dose or adjuvanted) in risk and control intervals among Medicare beneficiaries ≥ 65 years. We used conditional Poisson regression to estimate incidence rate ratios (IRRs) and 95 % confidence intervals (CIs) adjusted for event-dependent observation time and seasonality. Analyses also accounted for uncertainty from outcome misclassification where feasible. For AEs with any statistically significant associations, we stratified results by concomitant vaccination status. RESULTS: Among 12.7 million vaccine recipients, we observed 76 anaphylaxis, 276 encephalitis/encephalomyelitis, 134 GBS and 75 transverse myelitis cases. Only rates of anaphylaxis were elevated in risk compared to control intervals. With all adjustments, an elevated, but non-statistically significant, anaphylaxis rate was observed following any (IRR: 2.40, 95% CI: 0.96-6.03), high-dose (IRR: 2.31, 95% CI: 0.67-7.91), and adjuvanted (IRR: 3.28, 95% CI: 0.71-15.08) influenza vaccination; anaphylaxis IRRs were 2.54 (95% CI: 0.49-13.05) and 1.64 (95% CI: 0.38-7.05) for persons with and without concomitant vaccination, respectively. CONCLUSIONS: Rates of encephalitis/encephalomyelitis, GBS, or transverse myelitis were not elevated following 2022-2023 seasonal influenza vaccinations among U.S. adults ≥ 65 years. There was an increased rate of anaphylaxis following influenza vaccination that may have been influenced by concomitant vaccination.


Assuntos
Vacinas contra Influenza , Influenza Humana , Vacinação , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Anafilaxia/epidemiologia , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Síndrome de Guillain-Barré/epidemiologia , Síndrome de Guillain-Barré/etiologia , Síndrome de Guillain-Barré/induzido quimicamente , Incidência , Vacinas contra Influenza/efeitos adversos , Vacinas contra Influenza/administração & dosagem , Influenza Humana/prevenção & controle , Influenza Humana/epidemiologia , Medicare/estatística & dados numéricos , Mielite Transversa/epidemiologia , Mielite Transversa/etiologia , Estações do Ano , Estados Unidos/epidemiologia , Vacinação/efeitos adversos
9.
BMJ Open Qual ; 13(2)2024 May 08.
Artigo em Inglês | MEDLINE | ID: mdl-38724111

RESUMO

INTRODUCTION: Transparency about the occurrence of adverse events has been a decades-long governmental priority, defining external feedback to healthcare providers as a key measure to improve the services and reduce the number of adverse events. This study aimed to explore surgeons' experiences of assessment by external bodies, with a focus on its impact on transparency, reporting and learning from serious adverse events. External bodies were defined as external inspection, police internal investigation, systems of patient injury compensation and media. METHODS: Based on a qualitative study design, 15 surgeons were recruited from four Norwegian university hospitals and examined with individual semi-structured interviews. Data were analysed by deductive content analysis. RESULTS: Four overarching themes were identified, related to influence of external inspection, police investigation, patient injury compensation and media publicity, (re)presented by three categories: (1) sense of criminalisation and reinforcement of guilt, being treated as suspects, (2) lack of knowledge and competence among external bodies causing and reinforcing a sense of clashing cultures between the 'medical and the outside world' with minor influence on quality improvement and (3) involving external bodies could stimulate awareness about internal issues of quality and safety, depending on relevant competence, knowledge and communication skills. CONCLUSIONS AND IMPLICATIONS: This study found that external assessment might generate criminalisation and scapegoating, reinforcing the sense of having medical perspectives on one hand and external regulatory perspectives on the other, which might hinder efforts to improve quality and safety. External bodies could, however, inspire useful adjustment of internal routines and procedures. The study implies that the variety and interconnections between external bodies may expose the surgeons to challenging pressure. Further studies are required to investigate these challenges to quality and safety in surgery.


Assuntos
Segurança do Paciente , Pesquisa Qualitativa , Cirurgiões , Humanos , Cirurgiões/psicologia , Cirurgiões/estatística & dados numéricos , Cirurgiões/normas , Noruega , Segurança do Paciente/normas , Segurança do Paciente/estatística & dados numéricos , Masculino , Feminino , Entrevistas como Assunto/métodos , Adulto , Pessoa de Meia-Idade , Melhoria de Qualidade , Qualidade da Assistência à Saúde/normas , Qualidade da Assistência à Saúde/estatística & dados numéricos , Atitude do Pessoal de Saúde
10.
J Neurooncol ; 168(1): 111-123, 2024 May.
Artigo em Inglês | MEDLINE | ID: mdl-38563855

RESUMO

PURPOSE: Glioblastoma (GB) is the most common primary malignant brain tumor with the highest incidence occurring in older adults with a median age at diagnosis of 64 years old. While treatment often improves survival it brings toxicities and adverse events (AE). Here we identify sex differences in treatment patterns and AE in individuals ≥ 66 years at diagnosis with GB. METHODS: Using the SEER-Medicare dataset sex differences in adverse events were assessed using multivariable logistic regression performed to calculate the male/female odds ratio (M/F OR) and 95% confidence intervals [95% CI] of experiencing an AE adjusted for demographic variables and Elixhauser comorbidity score. RESULTS: Males with GB were more likely to receive standard of care (SOC; Surgery with concurrent radio-chemotherapy) [20%] compared to females [17%], whereas females were more likely to receive no treatment [26%] compared to males [21%]. Females with GB receiving SOC were more likely to develop gastrointestinal disorders (M/F OR = 0.76; 95% CI,0.64-0.91, p = 0.002) or blood and lymphatic system disorders (M/F OR = 0.79; 95% CI,0.66-0.95, p = 0.012). Males with GB receiving SOC were more likely to develop cardiac disorders (M/F OR = 1.21; 95% CI,1.02-1.44, p = 0.029) and renal disorders (M/F OR = 1.65; 95% CI,1.37-2.01, p < 0.001). CONCLUSIONS: Sex differences for individuals, 66 years and older, diagnosed with GB exist in treatment received and adverse events developed across different treatment modalities.


Assuntos
Neoplasias Encefálicas , Glioblastoma , Medicare , Humanos , Masculino , Feminino , Idoso , Estados Unidos/epidemiologia , Glioblastoma/terapia , Glioblastoma/epidemiologia , Neoplasias Encefálicas/terapia , Neoplasias Encefálicas/epidemiologia , Idoso de 80 Anos ou mais , Caracteres Sexuais , Fatores Sexuais , Programa de SEER , Terapia Combinada/efeitos adversos
12.
Cancer Treat Rev ; 126: 102734, 2024 May.
Artigo em Inglês | MEDLINE | ID: mdl-38604051

RESUMO

Immunotherapy with immune checkpoint inhibitors (ICI) is increasingly employed in oncology. National and international endocrine and oncologic scientific societies have provided guidelines for the management of endocrine immune-related adverse events. However, guidelines recommendations differ according to the specific filed, particularly pertaining to recommendations for the timing of endocrine testing. In this position paper, a panel of experts of the Italian Association of Medical Oncology (AIOM), Italian Association of Medical Diabetologists (AMD), Italian Society of Diabetology (SID), Italian Society of Endocrinology (SIE), and Italian Society of Pharmacology (SIF) offers a critical multidisciplinary consensus for a clear, simple, useful, and easily applicable endocrine-metabolic assessment checklist for cancer patients on immunotherapy.


Assuntos
Imunoterapia , Neoplasias , Humanos , Neoplasias/tratamento farmacológico , Neoplasias/imunologia , Neoplasias/terapia , Imunoterapia/métodos , Itália , Lista de Checagem , Inibidores de Checkpoint Imunológico/uso terapêutico , Sociedades Médicas/normas , Doenças do Sistema Endócrino/induzido quimicamente , Oncologia/métodos
13.
Infect Dis Now ; 54(4): 104906, 2024 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-38580052

RESUMO

OBJECTIVES: Patients with bone and joint infections (BJI) are involved in a complex care pathway and require prolonged antimicrobial treatment. Some studies have suggested that a pharmacist-led telehealth intervention (TI) could help to ensure better follow-up of chronic diseases. To our knowledge, there are no data on the effects of pharmacist-led TI on patients with BJI. The aim of this study is to assess the impact of a TI on patients treated for BJIs at three weeks after hospital discharge. PATIENTS AND METHODS: Patients encountered during hospitalization and receiving standardized care including TI were included in the study. All adverse events (AE) reported by patients during TI were evaluated. Impact of pharmaceutical interventions (PIs) provided by a clinical pharmacist following TI was evaluated by CLEO© (CLinical, Economic and Organizational) scale. Patient satisfaction concerning TI was assessed by an anonymous questionnaire following medical consultation at the end of antimicrobial treatment. RESULTS: Over a 4-month period, 36 patients received TI. Fifty-two AEs were identified in 21 patients (58%). Two patients were hospitalized due to an AE. Clinical pharmacists provided 34 pharmaceutical interventions (PIs) for 23 patients (64%). According to CLEO scale, 11 PIs had a major clinical impact (32%), 6 PIs (18%) had a favorable impact on the direct cost of treatment and 27 PIs (79%) had positive organizational impact. Concerning TI process, patients were satisfied or very satisfied, with an average score of 9.6/10. CONCLUSION: TI led to a high number of pharmaceutical interventions (PIs), with a meaningful clinical, organizational, and economic impact. Patients were also highly satisfied with this intervention.


Assuntos
Satisfação do Paciente , Farmacêuticos , Telemedicina , Humanos , Feminino , Masculino , Idoso , Pessoa de Meia-Idade , Inquéritos e Questionários , Adulto , Artrite Infecciosa/tratamento farmacológico , Artrite Infecciosa/terapia , Idoso de 80 Anos ou mais , Hospitalização/estatística & dados numéricos , Antibacterianos/uso terapêutico
14.
Psychiatry Res ; 335: 115880, 2024 May.
Artigo em Inglês | MEDLINE | ID: mdl-38579460

RESUMO

Psychotherapies assisted by psychedelic substances have shown promising results in the treatment of psychiatric disorders. The aim of this systematic review and meta-analysis was to evaluate safety data in human subjects. We carried out a search on MEDLINE, Embase and PsycINFO databases between 2000 and 2022. Standardized mean differences between different dose ranges and between acute and subacute phases were calculated for cardiovascular data after psychedelic administration. Risk differences were calculated for serious adverse events and common side effects. Thirty studies were included in this meta-analysis. There were only nine serious adverse events for over 1000 administrations of psychedelic substances (one during the acute phase and 8 during the post-acute phase). There were no suicide attempts during the acute phase and 3 participants engaged in self-harm during the post-acute phase. There was an increased risk for elevated heart rate, systolic and diastolic blood pressure for all dose range categories, as well as an increased risk of nausea during the acute phase. Other common side effects included headaches, anxiety, and decreased concentration or appetite. This meta-analysis demonstrates that psychedelics are well-tolerated, with a low risk of emerging serious adverse events in a controlled setting with appropriate inclusion criteria.


Assuntos
Alucinógenos , Humanos , Alucinógenos/efeitos adversos , Alucinógenos/administração & dosagem , Medição de Risco , Psicoterapia
15.
Pan Afr Med J ; 47: 69, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38681100

RESUMO

Introduction: the risk management system is useful to identify, analyze, and reduce the risk occurrence of adverse events (AEs) in health services. This system suggests useful improvements to patients and to the whole institution and also contributes to the acquisition of a collective and organizational safety culture. This study presented a state of the art of the management of AEs identified in different services of a regional hospital in the north of Morocco. Methods: this is a retrospective cross-sectional exploratory study carried out from 2017 to 2019 using observations and semi-structured interviews, which were recorded, re-transcribed, and analyzed. Data was also collected from audit reports, results of investigations of the nosocomial infection control committee and the risk management commission, AEs declaration sheets, and meetings reports. Results: a number of 83 AEs were recorded, 10 of which were urgent. The reported events were related to care, infection risk, the drugs circuit, and medico-technical events. Two hundred cases of nosocomial infections were also recorded, of which 75 occurred in the intensive care unit and 35 in the maternity service. Surgical site infections were the most frequently reported complication. Adverse events were related to organizational failure, equipment problems, and errors related to professional practices. Conclusion: our findings may guide the improvement of the event management system in order to reduce the occurrence of future incidents. Thus, improving the risk management system requires setting up training strategies for staff on the importance of this system and its mode of operation.


Assuntos
Infecção Hospitalar , Erros Médicos , Gestão de Riscos , Humanos , Marrocos , Estudos Transversais , Estudos Retrospectivos , Gestão de Riscos/organização & administração , Infecção Hospitalar/prevenção & controle , Infecção Hospitalar/epidemiologia , Erros Médicos/prevenção & controle , Erros Médicos/estatística & dados numéricos , Hospitais , Feminino , Infecção da Ferida Cirúrgica/prevenção & controle , Infecção da Ferida Cirúrgica/epidemiologia , Masculino
16.
Rheum Dis Clin North Am ; 50(2): 181-199, 2024 May.
Artigo em Inglês | MEDLINE | ID: mdl-38670720

RESUMO

Immune checkpoint inhibitors (ICIs) have greatly improved survival of several cancers with historically very poor prognosis. ICIs act by stimulating the patient's own immune system to fight cancer. Simultaneously, this immune activation can lead to immune-related adverse events (irAEs), including rheumatic manifestations (Rh-irAEs). Rh-irAEs mimic primary rheumatic diseases including arthritis, polymyalgia rheumatica, myositis, vasculitis, sarcoidosis, and sicca. This article summarizes the latest evidence regarding the utility of laboratory investigations in Rh-irAEs.


Assuntos
Inibidores de Checkpoint Imunológico , Doenças Reumáticas , Humanos , Doenças Reumáticas/tratamento farmacológico , Doenças Reumáticas/imunologia , Inibidores de Checkpoint Imunológico/efeitos adversos , Neoplasias/imunologia , Neoplasias/tratamento farmacológico
17.
J Med Econ ; 27(1): 653-662, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38602691

RESUMO

OBJECTIVE: Attention-deficit/hyperactivity disorder (ADHD) medication is frequently associated with adverse events (AEs), but limited real-world data exist regarding their costs from a payer's perspective. Therefore, this study evaluated the healthcare costs associated with common AEs among adult patients treated for ADHD in the US. METHODS: Eligible adults treated for ADHD were identified from a large US claims database (1 October 2015-30 September 2021). A retrospective cohort study design was used to assess excess healthcare costs and costs directly related to AE-specific claims per-patient-per-month (PPPM) associated with 10 selected AEs during ADHD treatment. To account for all costs associated with the AE, treatment episodes with a given AE were compared to similar treatment episodes without this AE. Entropy balancing was used to create cohorts with similar characteristics. Studied AEs were selected based on their prevalence in clinical trials for common ADHD medications and were identified from ICD-10-CM diagnosis codes recorded in claims. RESULTS: Among the 461,464 patients included (mean age: 34.2 years; 45.5% males), 49.4% had ≥1 AE during their treatment episode. Treatment episodes with AEs were associated with statistically significant AE-specific medical costs (erectile dysfunction: $57; fatigue: $82; dry mouth: $90; diarrhea: $162; insomnia: $147; anxiety: $281; nausea: $299; constipation: $356; urinary hesitation: $491; feeling jittery: $723) and excess healthcare costs PPPM (erectile dysfunction: $120, fatigue: $248, insomnia: $265, anxiety: $380, diarrhea: $441, dry mouth: $485, nausea: $709, constipation: $802, urinary hesitation: $1,105, feeling jittery: $1,160; p < .05). LIMITATIONS: AEs were identified based on recorded diagnosis on medical claims and likely represent more severe AEs. Therefore, costs may not be representative of milder AEs. CONCLUSIONS: This study found that AEs occurring during ADHD treatment episodes are associated with significant healthcare costs. This highlights the potential of treatments with favorable safety profiles to alleviate the burden experienced by patients and the healthcare system.


Assuntos
Transtorno do Deficit de Atenção com Hiperatividade , Revisão da Utilização de Seguros , Humanos , Transtorno do Deficit de Atenção com Hiperatividade/economia , Transtorno do Deficit de Atenção com Hiperatividade/tratamento farmacológico , Masculino , Feminino , Adulto , Estudos Retrospectivos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/economia , Pessoa de Meia-Idade , Estados Unidos , Estimulantes do Sistema Nervoso Central/efeitos adversos , Estimulantes do Sistema Nervoso Central/economia , Adulto Jovem , Custos de Cuidados de Saúde/estatística & dados numéricos , Gastos em Saúde/estatística & dados numéricos , Adolescente
18.
Value Health ; 27(7): 936-942, 2024 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-38548180

RESUMO

OBJECTIVE: Inclusion of relevant effectiveness and safety outcomes in economic evaluation of health technologies is required to aid efficient healthcare decisions. Our objective was to identify the key issues related to the inclusion of adverse events (AEs) in economic evaluation and explore perspectives for good practice recommendations to handle these issues. METHODS: We focused on the frequently encountered methodological issues related to the integration of AEs in economic evaluations of health technologies. We distinguished the following elements: the incorporation of AEs in decision models, the terminology of AEs, the estimation of AEs consequences in terms of quality of life (QoL) and costs, and the exploration of the uncertainty related to the impact of AEs on the economic results. RESULTS: We illustrated and discussed each of the identified issues by giving health technology assessment examples. We focused on the extent to which the integration of AEs in decision models can be improved by dealing with the lack of relevant real-world safety data, estimating the consequences of AEs (eg, for costs and QoL loss), exploring the impacts of AEs that are not adequately captured in current measurement of health-related QoL, and identifying the need for development of a good terminology of relevant types of AEs to be incorporated in economic evaluation. CONCLUSION: Based on a reflection the key methodological issues related to the incorporation of adverse drug events in economic evaluations, we suggested several recommendations to serve a starting point for health technology assessment agencies and researchers to develop good research practices in this field.


Assuntos
Análise Custo-Benefício , Qualidade de Vida , Avaliação da Tecnologia Biomédica , Humanos , Análise Custo-Benefício/métodos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/economia , Técnicas de Apoio para a Decisão , Incerteza , Terminologia como Assunto , Modelos Econômicos
19.
Age Ageing ; 53(3)2024 03 01.
Artigo em Inglês | MEDLINE | ID: mdl-38497237

RESUMO

BACKGROUND: Limited evidence exists on the short- and long-term safety of discontinuing versus continuing chronic opioid therapy (COT) among patients with Alzheimer's disease and related dementias (ADRD). METHODS: This cohort study was conducted among 162,677 older residents with ADRD and receipt of COT using a 100% Medicare nursing home sample. Discontinuation of COT was defined as no opioid refills for ≥90 days. Primary outcomes were rates of pain-related hospitalisation, pain-related emergency department visit, injury, opioid use disorder (OUD) and opioid overdose (OD) measured by diagnosis codes at quarterly intervals during 1- and 2-year follow-ups. Poisson regression models were fit using generalised estimating equations with inverse probability of treatment weights to model quarterly outcome rates between residents who discontinued versus continued COT. RESULTS: The study sample consisted of 218,040 resident episodes with COT; of these episodes, 180,916 residents (83%) continued COT, whereas 37,124 residents (17%) subsequently discontinued COT. Discontinuing (vs. continuing) COT was associated with higher rates of all outcomes in the first quarter, but these associations attenuated over time. The adjusted rates of injury, OUD and OD were 0, 69 and 60% lower at the 1-year follow-up and 11, 81 and 79% lower at the 2-year follow-up, respectively, for residents who discontinued versus continued COT, with no difference in the adjusted rates of pain-related hospitalisations or emergency department visits. CONCLUSIONS: The rates of adverse outcomes were higher in the first quarter but lower or non-differential at 1-year and 2-year follow-ups between COT discontinuers versus continuers among older residents with ADRD.


Assuntos
Doença de Alzheimer , Transtornos Relacionados ao Uso de Opioides , Humanos , Idoso , Estados Unidos/epidemiologia , Analgésicos Opioides/efeitos adversos , Estudos de Coortes , Doença de Alzheimer/diagnóstico , Doença de Alzheimer/tratamento farmacológico , Doença de Alzheimer/epidemiologia , Medicare , Transtornos Relacionados ao Uso de Opioides/tratamento farmacológico , Dor/tratamento farmacológico , Estudos Retrospectivos
20.
CJEM ; 26(5): 333-338, 2024 May.
Artigo em Inglês | MEDLINE | ID: mdl-38519830

RESUMO

OBJECTIVES: Acute atrial fibrillation and flutter (AF/AFL) are common arrhythmias treated in the emergency department (ED). The 2021 CAEP Best Practices Checklist provides clear recommendations for management of patients with acute AF/AFL. This study aimed to evaluate physician compliance to Checklist recommendations for risk assessment and ED management of AF/AFL. METHODS: This health records review assessed the management of adult patients presenting to two tertiary care EDs for management of acute AF/AFL from January to August, 2022. All ECGs demonstrating AF/AFL with a heart rate greater than 100 were compiled to capture primary and secondary causes. All visits were assessed for rate and rhythm control management, adverse events, return to ED, and safety criteria. Study physicians classified safety criteria from the Checklist into high and moderate concerns. The primary outcome was the proportion of cases with safety concerns and adverse events occurring during management in the ED. Data were analyzed using simple descriptive statistics. RESULTS: We included 429 patients with a mean age of 67.7 years and 57.1% male. ED management included rate control (20.4%), electrical (40.1%), and pharmacological (20.1%) cardioversion. Adverse events occurred in 9.5% of cases: 12.5% in rate control, 13.4% in electrical cardioversion, and 6.9% in pharmacologic cardioversion. Overall, 7.9% of cases had management safety concerns. Moderate safety concerns occurred in 4.9% of cases including failure to attain recommended heart rate at time of discharge (3.9%). Severe concerns were identified in 3.0% of cases including failure to cardiovert unstable patients (1.2%). The 30-day return-to-ED rate was 16.5% secondary to AF/AFL. CONCLUSION: ED management of AF/AFL was consistent with the CAEP Checklist and was safe overall. Opportunities for optimizing care include attaining recommended targets during rate control, avoidance of calcium channel and beta blockers in patients with systolic dysfunction, and earlier cardioversion for clinically unstable patients.


ABSTRAIT: OBJECTIFS: La fibrillation auriculaire aiguë et le flutter (FA/FAT) sont des arythmies courantes traitées aux urgences (SU). La liste de vérification des pratiques exemplaires 2021 du CAEP fournit des recommandations claires pour la prise en charge des patients atteints de FA/FAT aiguës. Cette étude visait à évaluer la conformité des médecins aux recommandations de la liste de contrôle pour l'évaluation des risques et la gestion de la FA/FAT. MéTHODES: Cet examen des dossiers de santé a évalué la prise en charge des patients adultes qui se sont présentés à deux urgences de soins tertiaires pour la prise en charge des FA/FAT aiguës de janvier à août 2022. Tous les ECG démontrant une FA/FAT avec une fréquence cardiaque supérieure à 100 ont été compilés pour capturer les causes primaires et secondaires. Toutes les visites ont été évaluées pour la gestion du contrôle des taux et du rythme, les événements indésirables, le retour à l'urgence et les critères de sécurité. Les médecins de l'étude ont classé les critères d'innocuité de la liste de contrôle en préoccupations élevées et modérées. Le résultat principal était la proportion de cas présentant des préoccupations en matière de sécurité et des événements indésirables survenant pendant la prise en charge à l'urgence. Les données ont été analysées à l'aide de statistiques descriptives simples. RéSULTATS: Nous avons inclus 429 patients avec un âge moyen de 67.7 ans et 57.1% d'hommes. La prise en charge de l'urgence comprenait une cardioversion contrôlée (20.4 %), électrique (40.1 %) et pharmacologique (20.1 %). Des événements indésirables se sont produits dans 9.5% des cas : 12.5% dans le contrôle du taux, 13.4% dans la cardioversion électrique et 6.9% dans la cardioversion pharmacologique. Dans l'ensemble, 7.9 % des cas concernaient la sécurité de la direction. Des problèmes de sécurité modérés sont survenus dans 4.9 % des cas, y compris l'incapacité d'atteindre la fréquence cardiaque recommandée au moment du congé (3.9 %). Des préoccupations graves ont été identifiées dans 3.0 % des cas, y compris l'échec à cardiovert patients instables (1.2 %). Le taux de retour aux urgences après 30 jours était de 16,5 % secondaire aux FA/FAT. CONCLUSION: La gestion de l'AF/AFL par le DG était conforme à la liste de vérification du CAEP et était sécuritaire dans l'ensemble. Les possibilités d'optimisation des soins comprennent l'atteinte des cibles recommandées lors du contrôle des taux, l'évitement du canal calcique et des bêtabloquants chez les patients présentant une dysfonction systolique et une cardioversion antérieure pour les patients cliniquement instables.


Assuntos
Fibrilação Atrial , Lista de Checagem , Serviço Hospitalar de Emergência , Fidelidade a Diretrizes , Humanos , Fibrilação Atrial/terapia , Masculino , Feminino , Idoso , Frequência Cardíaca/fisiologia , Estudos Retrospectivos , Pessoa de Meia-Idade , Guias de Prática Clínica como Assunto , Eletrocardiografia , Cardioversão Elétrica/métodos , Antiarrítmicos/uso terapêutico , Medição de Risco
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