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1.
Am J Drug Alcohol Abuse ; 49(2): 199-205, 2023 03 04.
Artigo em Inglês | MEDLINE | ID: mdl-36820614

RESUMO

Background: Law enforcement agencies in the US have provided naloxone to officers and developed initiatives to follow-up after a non-fatal overdose. However, the prevalence and characteristics of these efforts have yet to be documented in research literature.Objectives: We sought to understand the national prevalence of naloxone provision among law enforcement and examine the implementation of post-overdose follow-up.Methods: We administered a survey on drug overdose response initiatives using a multimodal approach (online and mail) to a nationally representative sample of law enforcement agencies (N = 2,009; 50.1% response rate) drawn from the National Directory of Law Enforcement Administrators database. We further examine a subsample of agencies (N = 1,514) that equipped officers with naloxone who were also asked about post-overdose follow-up.Results: We found 81.7% of agencies reported officers were equipped with naloxone; among these, approximately one-third (30.3%) reported follow-up after an overdose. More than half (56.8%) of agencies indicated partnership in follow-up with emergency medical services as the most common partner (68.8%). There were 21.4% of agencies with a Quick Response Team, a popular national post-overdose model, and were more likely to indicate partnership with a substance use disorder treatment provider than when agencies were asked generally about partners in follow-up (74.5% and 26.2% respectively).Conclusion: Many law enforcement agencies across the US have equipped officers with naloxone, and about one-third of those are conducting follow-up to non-fatal overdose events. Post-overdose follow-up models and practices vary in ways that can influence treatment engagement and minimize harms against persons who use drugs.


Assuntos
Overdose de Drogas , Aplicação da Lei , Humanos , Antagonistas de Entorpecentes/uso terapêutico , Polícia , Naloxona/uso terapêutico , Overdose de Drogas/tratamento farmacológico , Overdose de Drogas/epidemiologia , Overdose de Drogas/prevenção & controle
2.
Pediatr Blood Cancer ; 69(8): e29602, 2022 08.
Artigo em Inglês | MEDLINE | ID: mdl-35561013

RESUMO

In January 2021, the U.S. Food and Drug Administration (FDA) approved crizotinib for pediatric patients 1 year and older and young adults with relapsed or refractory systemic anaplastic large cell lymphoma (sALCL). This is the first approval for pediatric sALCL. Approval was based on a single-arm trial of crizotinib monotherapy that included 26 patients, aged 1-20 years, with previously treated sALCL. Efficacy was based on centrally assessed objective response rate (88%) and duration of response. Herein, we highlight unique aspects of the regulatory review, including extension of the indication to young adults, postmarketing safety, and dose optimization strategies.


Assuntos
Imunoconjugados , Linfoma Anaplásico de Células Grandes , Criança , Crizotinibe/uso terapêutico , Humanos , Linfoma Anaplásico de Células Grandes/tratamento farmacológico , Linfoma Anaplásico de Células Grandes/patologia , Recidiva Local de Neoplasia/tratamento farmacológico , Inibidores de Proteínas Quinases/efeitos adversos , Estados Unidos , United States Food and Drug Administration , Adulto Jovem
3.
Clin Trials ; 19(6): 690-696, 2022 12.
Artigo em Inglês | MEDLINE | ID: mdl-36086812

RESUMO

Master protocol studies typically use an overarching protocol to answer several questions by guiding a variety of sub-studies. These sub-studies can incorporate multiple diseases, therapies, or both. Although this innovative approach offers many benefits, including the ability to deliver clinical research that is more patient-centric and efficient, several common barriers curtail widespread adoption. The Clinical Trials Transformation Initiative (CTTI) convened industry representatives, regulatory agencies, patient groups, and academic institutions to identify emerging best practices and develop resources designed to help sponsors and other stakeholders overcome these challenges. We first identify some broad changes needed in the clinical trials ecosystem to facilitate mainstream adoption of master protocol studies, and we subsequently summarize CTTI's resources designed to support this effort.


Assuntos
Ecossistema , Humanos , Universidades
4.
Oncologist ; 26(10): 879-886, 2021 10.
Artigo em Inglês | MEDLINE | ID: mdl-34132444

RESUMO

In June 2020, the U.S. Food and Drug Administration granted accelerated approval to selinexor for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least two lines of systemic therapy. Approval was based on SADAL, a multicenter trial of selinexor monotherapy in patients with DLBCL after two to five systemic regimens. Efficacy was based on independent review committee-assessed objective response rate (ORR) and duration of response using Lugano criteria. In 134 patients treated with the approved dosage (60 mg orally on days 1 and 3 of each week), the ORR was 29% (95% confidence interval, 22-38), with complete response in 13% and with 38% of responses lasting at least 6 months. Gastrointestinal toxicity developed in 80% of patients, hyponatremia in 61%, central neurological toxicity (such as dizziness and mental status changes) in 25%, and ocular toxicity in 18%. New or worsening grade 3 or 4 thrombocytopenia, lymphopenia, neutropenia, anemia, or hyponatremia developed in ≥15%. Adverse reactions led to selinexor dose interruption in 61% of patients, dose reduction in 49%, and permanent discontinuation in 17%, with thrombocytopenia being the leading cause of dose modifications. Postmarketing studies will evaluate reduced dosages of selinexor and further evaluate clinical benefit in patients with relapsed or refractory DLBCL. IMPLICATIONS FOR PRACTICE: Selinexor is a new potential option for adults with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified, in the third-line setting or beyond. Toxicities are typically manageable but can be difficult to tolerate and necessitate close monitoring and supportive care.


Assuntos
Linfoma Difuso de Grandes Células B , Neutropenia , Humanos , Hidrazinas , Linfoma Difuso de Grandes Células B/tratamento farmacológico , Estudos Multicêntricos como Assunto , Resultado do Tratamento , Triazóis
5.
Foot Ankle Surg ; 27(8): 879-883, 2021 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-33277173

RESUMO

BACKGROUND: The purpose of this study was to analyze a comprehensive database to 1) compare patient demographic profiles; and 2) identify patient-related risk factors for surgical site infections (SSIs) following open reduction and internal fixation (ORIF) for lateral malleolar ankle fractures. METHODS: Patients treated with ORIF for lateral malleolar ankle fractures that developed SSIs within 1-year following the procedure were identified. Study group demographics were compared to a control cohort and risks for developing SSI were calculated using multivariate logistic regression analysis. RESULTS: There were statistically significant differences between the control group and patients with SSIs. The study showed that morbidly obese patients, peripheral vascular disease, and electrolyte/fluid imbalance were the greatest risk factors for developing SSIs following ORIF for lateral malleolar fractures. CONCLUSION: The study is useful as it can allow orthopaedists to optimize these high-risk patients to potentially mitigate this adverse event.


Assuntos
Fraturas do Tornozelo , Obesidade Mórbida , Fraturas do Tornozelo/diagnóstico por imagem , Fraturas do Tornozelo/cirurgia , Demografia , Fixação Interna de Fraturas/efeitos adversos , Humanos , Medicare , Estudos Retrospectivos , Fatores de Risco , Infecção da Ferida Cirúrgica/epidemiologia , Infecção da Ferida Cirúrgica/etiologia , Resultado do Tratamento , Estados Unidos/epidemiologia
6.
Pediatr Blood Cancer ; 67(12): e28688, 2020 12.
Artigo em Inglês | MEDLINE | ID: mdl-32896942

RESUMO

On May 16, 2019, the U.S. Food and Drug Administration (FDA) approved dalteparin sodium for the treatment of symptomatic venous thromboembolism (VTE) to reduce the risk of recurrence in pediatric patients 1 month of age and older. Approval was primarily based on FDA review of a single-arm trial evaluating dalteparin administered subcutaneous twice daily in 38 pediatric patients with symptomatic VTE. Efficacy was based on the achievement of therapeutic plasma anti-Xa levels. The FDA concluded that dalteparin has efficacy and acceptable safety for pediatric patients.


Assuntos
Anticoagulantes/uso terapêutico , Dalteparina/uso terapêutico , Aprovação de Drogas , Tromboembolia Venosa/tratamento farmacológico , Adolescente , Adulto , Criança , Pré-Escolar , Feminino , Seguimentos , Humanos , Lactente , Recém-Nascido , Masculino , Prognóstico , Estados Unidos , United States Food and Drug Administration , Tromboembolia Venosa/patologia , Adulto Jovem
7.
Oncologist ; 24(5): e180-e187, 2019 05.
Artigo em Inglês | MEDLINE | ID: mdl-30914464

RESUMO

In November 2018, the U.S. Food and Drug Administration (FDA) approved brentuximab vedotin (BV) for the treatment of adult patients with previously untreated systemic anaplastic large cell lymphoma or other CD30-expressing peripheral T-cell lymphomas (PTCL), including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified, in combination with cyclophosphamide, doxorubicin, and prednisone (CHP). Approval was based on ECHELON-2, a randomized, double-blind, actively controlled trial that compared BV+CHP with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) in 452 patients with newly diagnosed, CD30-expressing PTCL. Efficacy was based on independent review facility-assessed progression-free survival (PFS). The median PFS was 48.2 months with BV+CHP versus 20.8 months with CHOP, resulting in a hazard ratio (HR) of 0.71 (95% confidence interval [CI]: 0.54-0.93). The trial also demonstrated improvement in overall survival (HR 0.66; 95% CI: 0.46-0.95), complete response rate (68% vs. 56%), and overall response rate (83% vs. 72%) with BV+CHP. The most common adverse reactions (incidence ≥20%) observed ≥2% more with BV+CHP were nausea, diarrhea, fatigue or asthenia, mucositis, pyrexia, vomiting, and anemia. Peripheral neuropathy rates were similar (52% with BV+CHP, 55% with CHOP). Through the Real-Time Oncology Review pilot program, which allows FDA early access to key data, FDA granted this approval less than 2 weeks after official submission of the application. IMPLICATIONS FOR PRACTICE: This is the first U.S. Food and Drug Administration approval for treatment of patients with newly diagnosed peripheral T-cell lymphomas (PTCL). Improvement in progression-free and overall survival over cyclophosphamide, doxorubicin, vincristine, and prednisone chemotherapy, which has been the standard of care for decades, is unprecedented. The new regimen represents a major advance for the frontline treatment of patients with CD30-expressing PTCL.


Assuntos
Antineoplásicos Imunológicos/uso terapêutico , Brentuximab Vedotin/uso terapêutico , Linfoma de Células T Periférico/tratamento farmacológico , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Antineoplásicos Imunológicos/farmacologia , Brentuximab Vedotin/farmacologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estados Unidos , United States Food and Drug Administration , Adulto Jovem
8.
Arthroscopy ; 34(4): 1272-1279, 2018 04.
Artigo em Inglês | MEDLINE | ID: mdl-29287948

RESUMO

PURPOSE: To assess the readability and comprehension of written text by the most commonly visited websites containing patient education materials on common conditions that can be treated arthroscopically. METHODS: We examined 50 websites, assessed independently by 2 orthopaedic surgery residents (S.A. and G.G.), with educational materials on 5 common conditions treated by arthroscopic surgeons: anterior cruciate ligament (ACL) tear, meniscus tear, hip labral tear, shoulder labral tear, and rotator cuff tear. Following a Google search for each condition, we analyzed the 10 most visited websites for each disorder using a widely used and validated tool for assessing the reading levels of written materials (Flesch-Kincaid formula). RESULTS: The average grade reading level of the 50 websites studied was 9.90 with a reading ease of 52.14 ("fairly difficult, high school"). Only 26% of the websites were at or below the national average of an eighth-grade reading level. Of the 5 conditions treated by arthroscopic surgery, ACL tear had the highest average grade reading level at 10.73 ± 1.54, whereas meniscus tear had the lowest at 9.31 ± 1.81. Every condition in this study had an average readability at or above the ninth-grade reading level. CONCLUSIONS: The most frequently accessed materials for patients with injuries requiring arthroscopic surgery exceeds the readability recommendations of the American Medical Association and National Institutes of Health, as well as the average reading ability of US adults. Given the fact that these are the most commonly visited websites by the lay public, there needs to be a greater emphasis on tailoring written information to the literacy levels of the patient population. CLINICAL RELEVANCE: This study emphasizes the discrepancy between the recommended versus the measured reading levels of online patient education materials related to conditions treated by arthroscopic surgeons. The subject matter of these conditions is inherently complex; thus, relying solely on text to inform patients increases the likelihood that the reading level of the material exceeds that of the majority of the lay public.


Assuntos
Artroscopia , Compreensão , Informação de Saúde ao Consumidor/estatística & dados numéricos , Letramento em Saúde , Internet , Humanos
9.
J Hand Surg Am ; 43(8): 774.e1-774.e5, 2018 08.
Artigo em Inglês | MEDLINE | ID: mdl-29500047

RESUMO

PURPOSE: Transecting the extensor pollicis longus (EPL) tendon and rerouting it through the first extensor compartment is an established technique for treating thumb-in-palm deformity (TIPD). An alternative technique that approximates the trajectory of the first extensor compartment without violating the compartment or transecting the EPL tendon can be accomplished by creating an artificial sheath from the extensor retinaculum to radialize the tendon glide path. This study compares this extracompartmental (EC) EPL transposition to the established, intracompartmental (IC) transposition by evaluating, in a cadaver model, the extent of thumb extension in both techniques. METHODS: Eighteen fresh-frozen cadaveric hands were each tested under 3 different conditions: EPL in situ (baseline); EPL rerouted above the first extensor compartment (EC); and EPL rerouted through the first extensor compartment (IC). A controlled traction of 10 N was applied to the EPL under each condition. The range of thumb extension with respect to the fixed index finger was recorded utilizing infrared reflective markers and digital video capture. RESULTS: The mean extension of the thumb with the EPL tendon in situ was 16.7°. The mean extension of the thumb was 22.0° with the EC transposition versus 25.0° with the IC technique. The measured thumb extension in both the EC and the IC techniques were found to be similar because both EPL transpositions yielded a significant difference in thumb extension when compared with baseline. CONCLUSIONS: This biomechanical model demonstrates that radial transposition of the EPL tendon enhances extension of the thumb regardless of whether the tendon is routed through, or superficial to, the first extensor compartment. CLINICAL RELEVANCE: A novel technique, the EC EPL transposition, offers a similar enhancement in measured thumb extension as the already-described IC EPL transposition.


Assuntos
Deformidades Adquiridas da Mão/cirurgia , Transferência Tendinosa/métodos , Polegar/cirurgia , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Fenômenos Biomecânicos , Cadáver , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Polegar/anormalidades , Adulto Jovem
11.
Clin J Sport Med ; 25(4): 338-40, 2015 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-25290106

RESUMO

OBJECTIVE: Golf is a widely popular sport in the United States with 29 million Americans participating in the game. With an aging population and increased incidence of glenohumeral degenerative arthritis, the number of active golfers requiring total shoulder replacement is on the rise. This study aims to evaluate the effect of total shoulder replacement on golfing activity. DESIGN: Retrospective; questionnaire. SETTING: Survey. PARTICIPANTS: Three hundred sixty-seven patients were identified based on Current Procedural Terminology codes who underwent total shoulder arthroplasty (TSA) between January 2004 and January 2013. INTERVENTIONS: A voluntary anonymous questionnaire was sent to patients by mail including both objective and subjective questions about their level of golf activity and ability both before and after the surgery. MAIN OUTCOME MEASURES: Two hundred sixty-eight (73%) patients responded with 35 (34 right-handed and 1 left-handed patients) golfers completing the questionnaire. Results including visual analog pain scores, handicap change, and driving distance were evaluated statistically using the Student t test. RESULTS: Thirty-five golfers at an average time of 3.2 years after TSA completed the questionnaire with 31/35 being able to return to the sport at an average time of 8.4 months postoperatively. Thirty of 31 patients reported improvement in their pain level during and after golfing activity by an average of 4.3 (P < 0.05) on a visual analog scale (VAS) for pain. On average, driving distances increased by 12.5 yd (P = 0.0012) and handicap improved by 1.4 strokes (P = 0.03). CONCLUSIONS: Patients who undergo TSA for primary glenohumeral arthritis can safely return to golfing activity with a significant decrease in their perceived pain level as per VAS scores. Statistically significant findings included an increase in driving distance by 12.5 yd and an improvement in handicap by 1.4. CLINICAL RELEVANCE: In counseling patients, it is the authors' opinion that based on our experience with golfers undergoing TSA, patients can safely return to sport at an average of 8.4 months. The likelihood of return to play was quite high, but not 100%, and as such no guarantee should be provided to patients. Outcomes of patients with TSA desiring a return to golf are positive, and possible benefits include improvement of pain and possible improvements in driving distance and handicap. LEVEL OF EVIDENCE: IV.


Assuntos
Artroplastia de Substituição , Golfe , Osteoartrite/cirurgia , Volta ao Esporte , Articulação do Ombro/cirurgia , Idoso , Idoso de 80 Anos ou mais , Estudos de Coortes , Humanos , Pessoa de Meia-Idade , Atividade Motora , Estudos Retrospectivos , Inquéritos e Questionários , Resultado do Tratamento
12.
J Foot Ankle Surg ; 54(5): 852-5, 2015.
Artigo em Inglês | MEDLINE | ID: mdl-26058818

RESUMO

The purpose of the present study was to compare the hallux valgus deformity pressure parameters seen in standard footwear (no orthosis) versus the pressure observed in the same footwear with the addition of 3 different length orthoses. The forefoot pressure at a hallux valgus deformity was recorded with pressure sensors placed on the plantar, medial, and dorsal surface of the first metatarsal head. The participants performed walking trials without an orthosis and with orthoses of 3 different lengths. The average pressure and maximum pressure of each area was recorded for each orthosis, and comparisons were made across the groups. The plantar pressures were decreased in the full length and 3/4 length orthoses, and the dorsal pressures were increased with the use of the full-length and sulcus-length orthoses. Significant changes in medial pressure were not seen with the addition of any orthosis compared with standard footwear alone. However, a trend toward increased medial pressures was seen with the full- and sulcus-length orthoses, and the 3/4-length orthoses exhibited a trend toward decreased medial pressures. We were unable to demonstrate that the use of a custom foot orthosis significantly decreases the medial pressures on the first metatarsal head in patients with hallux valgus deformity. The 3/4-length orthosis was less likely to negatively affect the dorsal or medial pressures, which were noted to increase with the sulcus- and full-length orthoses. Our data suggest that if a clinician uses this treatment option, a 3/4-length orthosis might be a better choice than a sulcus- or full-length orthosis.


Assuntos
Órtoses do Pé , Hallux Valgus/diagnóstico , Hallux Valgus/reabilitação , Caminhada/fisiologia , Adulto , Fenômenos Biomecânicos , Desenho de Equipamento , Feminino , Deformidades Adquiridas do Pé/diagnóstico , Deformidades Adquiridas do Pé/reabilitação , Humanos , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Satisfação do Paciente/estatística & dados numéricos , Pressão , Índice de Gravidade de Doença
13.
Drug Alcohol Depend Rep ; 6: 100139, 2023 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-36994366

RESUMO

Background: As the overdose epidemic continues to worsen, nonfatal overdose calls for service represent a critical touchpoint for intervention. While most studies have focused on law enforcement led post-overdose follow-up, the current study describes the programmatic characteristics and outcomes of a non-law enforcement post overdose program comprised of peer specialists embedded within a local police department. Methods: We examined information on 341 follow-up responses occurring over a 16-month study period using administrative data. We assessed programmatic characteristics including demographic information on clients, referral source, engagement type, and goal completion. Results: The results indicate that over 60% of client referrals ended in the goal of in-person contact. Of those, about 80% went on to complete an engagement goal with the peer specialist. We found no significant variation in client demographics and referral source or follow-up engagement (in-person or not); however, client referrals from law enforcement first responders, the most common source, are significantly less likely to result in an in-person contact, though, if contact is made, similarly likely to complete an engagement goal. Conclusions: Post overdose response programs that do not involve law enforcement are exceedingly rare. Given that some research has shown that police involvement in post overdose response can have unexpected, associated harms, it is important to assess the effectiveness of post overdose programs that do not involve the police. Findings here suggest that this type of program is successful at locating and engaging community members into recovery support services who have experienced an overdose.

14.
Drug Alcohol Depend ; 248: 109916, 2023 Jul 01.
Artigo em Inglês | MEDLINE | ID: mdl-37236060

RESUMO

BACKGROUND: The United States continues to experience unprecedented rates of overdose mortality. Addressing the overdose epidemic has been challenging for policy makers given the lack of effectiveness of existing drug control policy measures. More recently, the implementation of harm reduction-based policies such as Good Samaritan Laws has led to increasing scholarly attention aimed at evaluating their effectiveness at reducing the likelihood of criminal justice-related sanctions for individuals following an overdose incident. The results of these studies, however, have been mixed. METHODS: This study utilizes data from a nationally representative survey of law enforcement agencies designed to provide national information on services, policies, practices, operations, and resources of law enforcement drug response around overdoses to assess whether state Good Samaritan Laws reduce the likelihood of overdose victims being cited or being jailed following an overdose incident. RESULTS: In general, findings indicate that although most agencies reported that overdose victims were not incarcerated or cited following an overdose incident, that this did not vary by whether agencies were in a state that had a GSL arrest protection for possession of controlled substances. CONCLUSIONS: GSLs are often written in complex and confusing language that officers and people who use drugs do not fully understand, which may deter their being used for their intended purpose. Although GSLs are well-intentioned, these findings highlight the need for training and education for law enforcement and people who use drugs around the scope of these laws.


Assuntos
Overdose de Drogas , Epidemias , Humanos , Estados Unidos/epidemiologia , Aplicação da Lei , Overdose de Drogas/tratamento farmacológico , Controle de Medicamentos e Entorpecentes , Intenção , Naloxona/uso terapêutico
15.
Injury ; 2023 Mar 20.
Artigo em Inglês | MEDLINE | ID: mdl-36964035

RESUMO

BACKGROUND: The purpose of this study was to apply both the fragility index (FI) and fragility quotient (FQ) to evaluate the degree of statistical fragility in the distal fibular fracture (DFF) literature. We hypothesized that the dichotomous outcomes within the DFF literature are statistically fragile. METHODS: We performed a PubMed search for distal fibular fractures clinical trials from 2000 to 2022 reporting dichotomous outcomes. The FI of each outcome was calculated through the reversal of a single outcome event until significance was reversed. The FQ was calculated by dividing each fragility index by study sample size. The interquartile range (IQR) was also calculated for the FI and FQ. RESULTS: Of the 1158 articles screened, 23 met the search criteria, with six RCTs included for analysis. Forty-five outcome events with 5 significant (p < 0.05) outcomes and 40 nonsignificant (p ≥ 0.05) outcomes were identified. The overall FI and FQ was 5 (IQR 4-6) and 0.089 (IQR 0.061-0.107), respectively. CONCLUSIONS: The randomized controlled trials in the peer-reviewed distal fibular fracture literature may not be as robust as previously thought, as incorporating statistical analyses solely on a P value threshold is misleading. Standardized reporting of the P value, FI and FQ can help the clinician reliably draw conclusions based on the fragility of outcome measures.

16.
Clin Cancer Res ; 29(15): 2748-2752, 2023 08 01.
Artigo em Inglês | MEDLINE | ID: mdl-36892497

RESUMO

Minimal residual disease (MRD) is increasingly used as a prognostic biomarker, a measure of clinical efficacy, and a guide for treatment decisions in various hematologic malignancies. We sought to characterize MRD data in registrational trials in hematologic malignancies submitted to the U.S. Food and Drug Administration (FDA) with the ultimate goal of expanding the utility of MRD data in future drug applications. We descriptively analyzed MRD data collected in registrational trials, including the type of MRD endpoint, assay, disease compartment(s) assessed, and the acceptance of MRD data in the U.S. prescribing information (USPI). Of 196 drug applications submitted between January 2014 and February 2021, 55 (28%) included MRD data. Of the 55 applications, MRD data was proposed by the Applicant for inclusion in the USPI in 41 (75%) applications but was included in only 24 (59%). Despite an increasing number of applications that proposed to include MRD data in the USPI, the acceptance rate decreased over time. Although MRD data have the potential to expedite drug development, our analysis identified challenges and specific areas for improvement, including assay validation, standardization of collection methods to optimize performance, and considerations in trial design and statistical methodology.


Assuntos
Neoplasias Hematológicas , Humanos , Estados Unidos , Preparações Farmacêuticas , Neoplasia Residual/tratamento farmacológico , Neoplasia Residual/patologia , United States Food and Drug Administration , Neoplasias Hematológicas/tratamento farmacológico
17.
Cancer Epidemiol Biomarkers Prev ; 32(6): 744-747, 2023 06 01.
Artigo em Inglês | MEDLINE | ID: mdl-37012203

RESUMO

INTRODUCTION: Molecularly targeted therapies such as tyrosine kinase inhibitors (TKI) are effective treatments for B-cell receptor (BCR)-ABL-bearing leukemias. We evaluated the impact of TKIs on historical chronic myeloid leukemia (CML) mortality trends compared with acute lymphoblastic leukemia (ALL) and chronic lymphoblastic leukemia (CLL). METHODS: Because mortality trends reflect combined effects of leukemia incidence and survival, we also evaluated the contribution of incidence and survival trends to mortality trends by subtypes. We used data from 13 U.S. (SEER) registries (1992-2017) among U.S. adults. We utilized histology codes to identify cases of CML, ALL, and CLL and death certificate data to calculate mortality. We used Joinpoint to characterize incidence (1992-2017) and mortality (1992-2018) trends by subtype and diagnosis year. RESULTS: For CML, mortality rates started declining in 1998 at an average rate of 12% annually. Imatinib was approved by the FDA for treating CML and ALL in 2001, leading to clear benefits for patients with CML. Five-year CML survival increased dramatically over time, especially between 1996 to 2011, 2.3% per year on average. ALL incidence increased 1.5% annually from 1992 to 2017. ALL mortality decreased 0.6% annually during 1992 to 2012 and then stopped declining. CLL incidence fluctuated during 1992 to 2017 while mortality decreased 1.1% annually during 1992 to 2011 and at a faster rate of 3.6% per year from 2011. Five-year survival increased 0.7% per year on average during 1992 to 2016. CONCLUSIONS: Survival benefit from TKIs and other novel therapies for treating leukemia subtypes has been demonstrated in clinical trials. IMPACT: Our study highlights the impact of molecularly targeted therapies at the population level.


Assuntos
Leucemia Linfocítica Crônica de Células B , Leucemia Mielogênica Crônica BCR-ABL Positiva , Adulto , Humanos , Mesilato de Imatinib/uso terapêutico , Leucemia Linfocítica Crônica de Células B/epidemiologia , Leucemia Mielogênica Crônica BCR-ABL Positiva/tratamento farmacológico , Leucemia Mielogênica Crônica BCR-ABL Positiva/epidemiologia , Sistema de Registros
19.
Health Justice ; 10(1): 9, 2022 Feb 25.
Artigo em Inglês | MEDLINE | ID: mdl-35212812

RESUMO

BACKGROUND: Many law enforcement agencies across the United States equip their officers with the life-saving drug naloxone to reverse the effects of an opioid overdose. Although officers can be effectively trained to administer naloxone, and hundreds of law enforcement agencies carry naloxone to reverse overdoses, little is known about what happens on scene during an overdose call for service from an officer's perspective, including what officers perceive their duties and responsibilities to be as the incident evolves. METHODS: The qualitative study examined officers' experiences with overdose response, their perceived roles, and what happens on scene before, during, and after an overdose incident. In-person interviews were conducted with 17 officers in four diverse law enforcement agencies in the United States between January and May 2020. RESULTS: Following an overdose, the officers described that overdose victims are required to go to a hospital or they are taken to jail. Officers also described their duties on scene during and after naloxone administration, including searching the belongings of the person who overdosed and seizing any drug paraphernalia. CONCLUSION: These findings point to a pressing need for rethinking standard operating procedures for law enforcement in these situations so that the intentions of Good Samaritan Laws are upheld and people get the assistance they need without being deterred from asking for future help.

20.
Drug Alcohol Depend ; 232: 109341, 2022 03 01.
Artigo em Inglês | MEDLINE | ID: mdl-35134733

RESUMO

BACKGROUND: The United States continues to experience a crisis of mounting opioid overdose deaths involving cocaine and methamphetamine (hereafter illicit stimulants). Law enforcement drug seizure data present a unique opportunity to examine the association between illicit-stimulant-involved overdose deaths (ISODs) and the illicit drug supply. Our objective is to better understand correlations between illicit drug market trends and increases in ISODs in Ohio in 2014-2019. METHODS: This observational study analyzes the universe of ISODs and drug seizures in Ohio from 2014 to 2019. We use graphs and descriptive statistics to characterize trends over time and estimate a time series model of their association. ISODs were summed to yield monthly statewide counts of seizures containing methamphetamine, cocaine, illicitly manufactured fentanyl (IMF), and other non-IMF opioids (e.g., heroin). All rates were calculated per 100,000 persons. RESULTS: Roughly 80% of ISODs in Ohio from 2014 to 2019 involved an opioid, with IMF co-occurring in 90% of ISODs by 2019. Methamphetamine and cocaine seizures containing IMF were associated with 0.439 (p < .01) and 0.457 (p < .01) additional deaths per 100,000 persons per month, respectively. IMF seizures not containing cocaine nor methamphetamine were also associated with additional ISODs (0.119, p < .01) and seizures of illicit stimulants not containing IMF were not associated with ISODs. CONCLUSIONS: The number of ISODs was extremely high when IMF was co-involved and relatively low without IMF involvement. By demonstrating how supply-side trends correspond with ISOD rates, the current study bolsters the analytical utility of law enforcement seizures and complements growing literature in the field.


Assuntos
Cocaína , Overdose de Drogas , Controle de Medicamentos e Entorpecentes , Drogas Ilícitas , Metanfetamina , Analgésicos Opioides , Overdose de Drogas/mortalidade , Fentanila , Humanos , Drogas Ilícitas/legislação & jurisprudência , Ohio/epidemiologia , Estados Unidos/epidemiologia
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