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BACKGROUND: Pediatric high blood pressure (BP) predicts future cardiovascular disease events. High BP is improperly measured, underrecognized, and undermanaged especially in disadvantaged populations. In a large, diverse, academic pediatric practice, we detail the associations of a comprehensive initiative with high BP provider recognition. METHODS: A comprehensive BP initiative was promulgated including (1) retraining providers and staff on BP management; (2) deploying equipment at 55+ sites; and (3) electronic decision support tool alerting staff and clinicians and suggesting management. During the 14-month preintervention and 14-month postintervention periods, data on BP and patient characteristics were collected. The outcome was incident BP recognition defined as any of the following: BP-specific International Classification of Diseases, Tenth Revision, diagnosis; problem list entry; specialty referral; diagnostic testing; repeat visit; or antihypertensives. Dichotomized as underpre versus at or over 13 years of age, analyses utilized interrupted time series and multivariable-adjusted logistic regression. RESULTS: From preintervention (children, n=105â 674; adolescents, n=54â 365) to postintervention (children, n=87â 917; adolescents, n=56â 470), the proportion measured with high BP declined in children and adolescents (30% versus 14% and 30% versus 15%, respectively, each P<0.001). Post-intervention, high BP provider recognition was 58% higher in children (4.6%-7.3%) and 43% higher in adolescents (7.9% versus 11.3%; P<0.001 for both). The improvement was not different in disadvantaged race, ethnicity, or zip codes. CONCLUSIONS: A comprehensive BP initiative was associated with more appropriate high BP measurement and recognition including in disadvantaged populations. Future work may address the low overall and nonsustained recognition and consideration of electronic decision support for pediatric BP management and mitigating disparities.
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INTRODUCTION: Prematurity is a significant cause of neonatal morbidity and mortality, especially in low-income and middle-income countries like Nepal. However, there is a paucity of data regarding its burden. This study aimed to determine the prevalence and outcomes of preterm neonates admitted to the neonatal intensive care unit of a tertiary care hospital. METHODS: This descriptive cross-sectional study was conducted among preterm neonates at a tertiary care hospital between July 15, 2022 to July 14, 2023 after obtaining ethical approval from the Institutional Review Committee (Reference number: F-NMC/557/078-079). Neonates with gestational age less than 37 weeks were included in the study. Total sampling method was used. RESULTS: Among 980 neonates admitted to intensive care unit, preterm neonates were 112 (11.43%). A total of 69 (61.61%) preterm neonates were outborn, and 65 (58.04%) were male. The median gestational age and birth weight were 32 weeks (interquartile range: 30- 34 weeks) and 1500 gm (interquartile range: 1300-1800 gm), respectively. There were 60 (53.57%) neonates with sepsis, 51 (45.54%) with neonatal jaundice and 38 (33.93%) with respiratory distress. Death occurred in 12 (10.71%) preterm neonates in the hospital. CONCLUSIONS: The prevalence of preterm neonates was similar to other studies done in similar settings.
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Edad Gestacional , Recien Nacido Prematuro , Unidades de Cuidado Intensivo Neonatal , Centros de Atención Terciaria , Humanos , Recién Nacido , Estudios Transversales , Unidades de Cuidado Intensivo Neonatal/estadística & datos numéricos , Nepal/epidemiología , Masculino , Femenino , Enfermedades del Prematuro/epidemiología , Síndrome de Dificultad Respiratoria del Recién Nacido/epidemiología , Prevalencia , Peso al Nacer , Ictericia Neonatal/epidemiologíaRESUMEN
This case report represents a 26-year-old male with no significant past medical history who presented to the emergency department in western Pennsylvania following a western diamondback rattlesnake (Crotalus Atrox) bite to his hand. His initial swelling was mild, and his coagulation studies were unremarkable, with minimal changes on repeat studies, and poison control recommended against antivenom administration. He was discharged home with oral antibiotics and analgesics due to his stable clinical course. However, he returned to the emergency department about 12 hours later with worsening pain and swelling that extended to his elbow. He was then given antivenom and transferred to a larger center for higher-level care, ultimately having symptom resolution after further antivenom administration. This report serves to underline the importance of clinician education regarding envenomation management throughout the United States, including areas without indigenous venomous snakes.
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Free Open-Access Medical Education (FOAMed) has transformed medical education in the past decade by complementing and substituting for traditional medical education when needed. The attractiveness of FOAMed resources is due to their inexpensive nature, wide availability, and user ability to access on demand across a variety of devices, making it easy to create, share, and participate. The subject of nephrology is complex, fascinating, and challenging. Traditional didactic lectures can be passive and ineffective in uncovering these difficult concepts and may need frequent revisions. Active teaching methods like flipped classrooms have shown some benefits, and these benefits can only be multifold with current social media tools. Social media will inspire the involvement of students and allow them to create and share educational content in a "trendy way," encouraging the participation of their peers and thus building an educational environment more conducive to them while promoting revision and retainment. FOAMed also promotes asynchronous learning, spaced learning, microlearning, and multimodal presentation with a meaningful variation. This article discusses the evolution of digital education, social media platforms, tools for creating and developing FOAMed resources, and digital scholarship.
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Nefrología , Pediatría , Medios de Comunicación Sociales , Medios de Comunicación Sociales/tendencias , Nefrología/educación , Nefrología/tendencias , Humanos , Pediatría/educación , Educación Médica/métodos , Educación Médica/tendencias , Educación a Distancia/métodos , Educación a Distancia/tendencias , CurriculumRESUMEN
INTRODUCTION: Effective patient assessment is often supported through simulated experiences where students identify potential drug-related problems (DRPs) through evaluation of the patient's electronic health record and verbally present their assessment and proposed resolutions for DRPs. This research aimed to initiate validation of a Patient Presentation to a Pharmacy Preceptor (4P) tool using exploratory factor analysis (EFA) to examine underlying constructs, refine items, and improve tool conciseness. The 4P tool was designed to assess student self-efficacy to identify, assess, resolve, and verbally present DRPs to a pharmacy preceptor. METHODS: The 4P instrument was administered to third-year doctor of pharmacy students in a performance-based skills laboratory course. EFA was conducted on student confidence data to examine underlying 4P constructs and improve survey conciseness. Laboratory faculty evaluated EFA results and came to consensus on factor extraction, item reduction and revision, and a finalized version of the 4P tool. RESULTS: Faculty interpretation of EFA results suggested elimination of two constructs resulting in a four-factor solution. Item evaluation further led to renaming the four constructs based on underlying factor themes. Out of the original 34-item tool, 13 items were eliminated, eight items were revised, and 1 new item was generated to retain relevant concepts. The refined 4P instrument contained four factors and 22 items. CONCLUSIONS: Use of EFA was useful to determine core 4P tool constructs and improved tool conciseness. This final four-factor model including 22 items will be used for a future confirmatory factor analysis.
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Educación en Farmacia , Farmacias , Farmacia , Estudiantes de Farmacia , Humanos , Educación en Farmacia/métodos , AutoeficaciaRESUMEN
Objective. To determine the association between pharmacy practice didactic course examinations and performance-based assessments with students' performance during their advanced pharmacy practice experiences (APPEs).Methods. This retrospective analysis included data from the graduating classes of 2018 to 2020. Students were coded as APPE poor performers (final course grade <83%) or acceptable performers. Assessments in pharmacy practice didactic and skills-based courses in students' second and third years were included in the analysis, with thresholds correlating to grade cutoffs. The association between poor performance mean examination scores and performance-based assessments with APPE performance was calculated.Results. Of the 403 graduates, analysis sample sizes ranged from 254 to 403. There were 49 students (12%) who met the criteria for poor performance in the APPE year. When comparing pharmacy practice didactic course performance to APPE poor performance, the proportion of mean examination scores that were <83% for six of the seven pharmacy practice didactic courses was significant; five of the seven mean examination scores were significant at the <78% threshold. Performance-based assessments that were significantly associated with APPE poor performance often required critical thinking.Conclusion. A gap in identification of students with APPE poor performance who did not fail a didactic course was demonstrated. Specifically, this finding suggests that pre-APPE curriculum should focus on assessments that include critical thinking. These methods could be used by other pharmacy programs to find components of their curricula that help identify students who need additional support prior to the APPE year.
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Educación en Farmacia , Farmacia , Estudiantes de Farmacia , Humanos , Evaluación Educacional/métodos , Estudios Retrospectivos , Educación en Farmacia/métodos , CurriculumRESUMEN
INTRODUCTION: Young women in sub-Saharan Africa account for two-thirds of all new HIV infections and face high rates of unintended pregnancy. Multipurpose prevention technologies (MPTs) are promising products under development that are designed to simultaneously prevent HIV and unintended pregnancy. Since MPTs will be used in the context of sexual relationships, ensuring acceptability and use requires understanding the role of male partners in MPT use decision-making. METHODS: This paper draws on qualitative data from 39 couples enrolled in the Microbicide Trials Network (MTN) 045 study, conducted in 2019-2020. Partners completed a discrete choice experiment (DCE), first separately and then jointly, to measure preferences for future MPT attributes and then completed a qualitative interview. We also draw on quantitative data from interviewer observation about who dominated the decision-making process during the joint DCE. Content analysis was used to examine (1) how couples made decisions on existing non-MPT HIV and pregnancy prevention products; (2) how couples made decisions on future ideal-MPT product during the DCE; and (3) how these decision-making processes varied by decision-making dominance (10 male, 10 female and 19 equal) and interview type (19 joint and 20 separate). RESULTS: Existing non-MPT product decisions focused on trust between partners and product attributes, while future ideal-MPT product decisions exclusively focused on product attributes. Across existing and future products, preferences for product attributes varied by gender. Male partners were most concerned with limiting side effects impacting sexual pleasure, female partners were most concerned with limiting side effects causing physical symptoms and both were concerned with the return to fertility. Across all dominance and interview types, couples reported making decisions together and female partners were often able to negotiate with male partners for their preferred product or set of product attributes. CONCLUSIONS: Research activities in this study provided an opportunity for couples to openly present their product attribute preferences to their partner, learn about their partner's attribute preferences, negotiate for their ideal set of attributes and ultimately choose attributes that benefited the couple without disempowering the female partner. Future research should focus on the utility of couple-based decision-making aids or similar tools for facilitating joint MPT decision-making.
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Antiinfecciosos , Infecciones por VIH , Anticoncepción , Femenino , Infecciones por VIH/prevención & control , Humanos , Masculino , Embarazo , Embarazo no Planeado , Parejas Sexuales , TecnologíaRESUMEN
BACKGROUND: A previously healthy 14-year-old girl was evaluated in the emergency department (ED) with 2 months of shortness of breath and fatigue. METHODS: She initially presented to her primary pediatrician, where a complete blood count was only significant for mild anemia, thyroid function tests were normal, and a chest x-ray revealed a chest mass. This prompted her primary pediatrician to order a computed tomography scan and refer to the ED. RESULTS: Her computed tomography scan confirmed a mediastinal mass versus necrotic lymphadenopathy. Her initial physical exam was unremarkable, except for hypertension. From the ED, she was admitted to the pediatric hospital medicine service. Infectious disease, oncology, and nephrology services were consulted to guide diagnostic evaluation. CONCLUSIONS: Eventually, during her hospitalization, further history and workup led to a definitive diagnosis.
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Disnea , Hipertensión , Adolescente , Niño , Disnea/etiología , Fatiga , Femenino , Humanos , Hipertensión/complicaciones , Radiografía , Tomografía Computarizada por Rayos X/métodosRESUMEN
OBJECTIVE: To establish content validity of a single-item, migraine-specific symptom severity questionnaire for completion by migraine patients, key family members (KFMs) of migraine patients, and Healthcare Professionals (HCPs) who treat migraine patients. BACKGROUND: Migraine is a common disabling primary headache disorder with high prevalence and significant socioeconomic burden and personal impacts. There is a need for a global assessment of migraine symptom severity to evaluate potential new therapies from multiple perspectives. METHODS: The migraine Global Impression Item (mGI-I) was drafted and tested in a non-interventional, qualitative study comprising telephone interviews with 15 migraine patients, 15 KFMs of migraine patients, and 15 migraine treating HCPs. The mGI-I was drafted with two different item stem options and two different response scale options to ask about the patient's migraine from the perspective of each respondent. Cognitive interviews were conducted to test comprehensiveness, clarity and ease of completion of the different versions of the mGI-I iteratively in three sequential waves of respondents. RESULTS: Revisions were made to the draft mGI-I after Wave 1 and Wave 2 of the interviews. Changes were made to simplify the item stem (removing unnecessary text), make language more patient-friendly (e.g. use of "migraine attack"), and add clarity to the item stem for consistent interpretation (include descriptive language of migraine attacks). Across both waves there was a preference for a 5-point response scale compared to a 7-point scale. In Wave 3, all respondents found the revised instructions, item stem, and 5-point response scale comprehensive, easy to understand and to answer. No further changes to the mGI-I were made after Wave 3. CONCLUSIONS: This qualitative study of 45 total respondents across 3 subpopulations, established the content validity and appropriateness of the mGI-I in migraine patients, KFMs, and migraine-treating HCPs. The study specifically confirmed that the mGI-I is comprehensive, easily understood and answered for each respondent population.
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Trastornos Migrañosos , Humanos , Trastornos Migrañosos/epidemiología , Investigación Cualitativa , Encuestas y CuestionariosAsunto(s)
Polidipsia , Poliuria , Adolescente , Mano , Humanos , Masculino , Polidipsia/etiología , Poliuria/etiologíaRESUMEN
OBJECTIVE: The purpose of this study was to examine changes in the functional impact of migraine following treatment with erenumab, as measured by the Migraine Functional Impact Questionnaire (MFIQ). BACKGROUND: The MFIQ, a novel patient-reported outcome (PRO) measuring the impact of migraine on four domains (physical function, social function, and emotional function [PF, SF, and EF]; usual activities [UAs]) and a single item assessing overall impact on UA, was included in phase III trials evaluating erenumab 70 and 140 mg monthly for migraine prevention among people with episodic migraine (EM). METHODS: In the ARISE study, 577 patients with EM were randomized to erenumab 70 mg or placebo. In the STRIVE study, 955 patients with EM were randomized to erenumab, 70 mg or 140 mg or placebo. Pairwise comparisons of least-squares mean (LSM) change from baseline in MFIQ scores (with associated 95% confidence interval [CI]) were assessed for each active treatment versus placebo. RESULTS: In ARISE, greater reductions from baseline to month 3 were observed for 70 mg versus placebo for PF (LSM [95% CI]: -3.2 [-6.4 to -0.1]; p = 0.046) and EF (-4.0 [-7.3 to -0.7]; p = 0.019) domain scores. In STRIVE, between-group differences also reflected reductions from baseline to the average of months 4-6 that favored erenumab on all four MFIQ domain scores. Reductions in impact for 70 mg compared to placebo were -4.3 (95% CI: -6.8 to -1.7; p < 0.001) for PF, -4.0 (-6.3 to -1.7; p < 0.001) for UA, -3.7 (-6.1 to -1.2; p = 0.003) for SF, and -5.3 (-7.9 to -2.6; p < 0.001) for EF domain scores. Improvements were also observed for 140 mg versus placebo with between-group differences of -5.7 (95% CI: -8.2 to -3.2; p < 0.001) in PF, -5.1 (-7.5 to -2.8; p < 0.001) in UA, -5.0 (-7.4 to -2.6; p < 0.001) in SF, and -7.2 (-9.9 to -4.5; p < 0.001) in EF domain scores. There were also greater improvements in the overall impact on UA score for 70 mg (LSM [95% CI]: -4.3 [-7.0 to -1.7]; p = 0.001) and 140 mg (-5.3 [-8.5 to -3.2]; p < 0.001) versus placebo. CONCLUSIONS: The MFIQ measures the frequency of impacts and level of difficulty on multiple functional domains that provide a more complete picture of the effects of migraine. MFIQ scores showed that in comparison with placebo, patients treated with erenumab had greater reductions in the functional impact of migraine, providing insight into treatment benefits that extend beyond improvements in clinical status and health-related quality of life previously reported based on clinical end points and other PROs.
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Actividades Cotidianas , Anticuerpos Monoclonales Humanizados/administración & dosificación , Emociones , Trastornos Migrañosos/tratamiento farmacológico , Interacción Social , Adulto , Anticuerpos Monoclonales Humanizados/uso terapéutico , Relación Dosis-Respuesta a Droga , Femenino , Humanos , Masculino , Medición de Resultados Informados por el Paciente , Calidad de Vida , Encuestas y CuestionariosRESUMEN
Therapeutic apheresis utilizes apheresis procedures in the treatment of a variety of conditions including kidney disease. Therapeutic plasma exchange (TPE) is the most common modality employed with the rationale of rapid reduction of a pathogenic substance distributed primarily in the intravascular compartment; however other techniques which adsorb such pathogenic substances or alter the immune profile have been utilized in diseases affecting native and transplanted kidneys. This article discusses the modalities and technical details of therapeutic apheresis and summarizes its role in individual diseases affecting the kidney. Complications related to pediatric apheresis procedures and specifically related to apheresis in kidney disease are also discussed. Though therapeutic apheresis modalities are employed frequently in children with kidney disease, most experiences are extrapolated from adult studies. International and national registries need to be established to elucidate the role of apheresis modalities in children with kidney disease.
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Eliminación de Componentes Sanguíneos , Enfermedades Renales , Eliminación de Componentes Sanguíneos/efectos adversos , Eliminación de Componentes Sanguíneos/métodos , Niño , Femenino , Humanos , Enfermedades Renales/terapia , Masculino , Intercambio Plasmático/efectos adversos , Intercambio Plasmático/métodos , Sistema de RegistrosRESUMEN
BACKGROUND: The Pharmacists' Patient Care Process (PPCP) was developed to describe a consistent process in which pharmacists in any setting provide patient care. Faculty at a midwestern university developed and refined an assessment tool which provides an indirect approach to measure student confidence in performing skills essential to the PPCP. The objective of this paper is to conduct a stepwise factor analysis to refine the PPCP survey. METHODS: Assessing appropriateness of survey response data led to an exploratory factor analysis (EFA) on student confidence data to refine the survey instrument and examine the underlying constructs that influence student responses. Post EFA, the results were presented to the research team that collaboratively reached consensus on inclusion or exclusion of items. RESULTS: EFA factor loadings identified a 4-factor solution suggesting elimination of 30 items from the original 53 item survey. Team discussions led to eliminating 29 items, combining two items and generation of 5 new items in order to retain important concepts. The outcome was a well-conceptualized and refined 29 item-survey model assessing 4 constructs. CONCLUSION: To potentially improve patient outcomes, it is imperative to utilize comprehensive yet concise survey instruments, like the PPCP Skills Self-Efficacy Survey, to prepare students to translate PPCP skills to practice.
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Educación en Farmacia , Estudiantes de Farmacia , Curriculum , Educación en Farmacia/métodos , Humanos , Atención al Paciente/métodos , Farmacéuticos , Autoeficacia , Encuestas y CuestionariosRESUMEN
Objective. To determine the appropriateness and feasibility of implementing the Individual Teamwork Observation and Feedback Tool (iTOFT) in advanced pharmacy practice experiences (APPEs) to allow direct observation and rating of students' interprofessional teamwork skills.Methods. In the academic year 2018-2019, preceptors administered iTOFT at least once during required acute care and ambulatory care APPEs. After administration, which involved direct observation of students' behavior on an interprofessional team, preceptors evaluated iTOFT results and offered feedback to students. To determine implementation success of the iTOFT activity, an implementation satisfaction survey was administered to preceptors and students, which included questions on appropriateness and feasibility.Results. The iTOFT activity was completed 149 times each during required acute care and ambulatory care APPEs. Results demonstrated positive teamwork behaviors, eg, no students received an "inappropriate" rating on any iTOFT item. The implementation survey response rate was 33% (34/102) for preceptors and 40% (50/125) for students. Both groups reported that the iTOFT activity was feasible. Respondents also reported that completing the iTOFT activity did not interfere with workflow and that it was not difficult to find opportunities to complete it. Per preceptor report, mean time to complete the iTOFT activity was 37.7 minutes, but there were concerns identified regarding fidelity with all iTOFT steps.Conclusion. Incorporation of the iTOFT activity into the required acute and ambulatory care APPEs at a school of pharmacy was feasible. Future directions include determining ways to increase iTOFT fidelity.
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Educación en Farmacia , Servicios Farmacéuticos , Farmacia , Estudiantes de Farmacia , Educación en Farmacia/métodos , Retroalimentación , HumanosRESUMEN
BACKGROUND: Qualitative and mixed methods approaches are commonly used to understand participants' interactions with real-world settings and can help health services researchers to obtain realistic details about patients' health behaviors. However, interviews do not easily capture data about how patients perform health-related behaviors that are not part of their daily routine. A scenario-based approach is one method that can be used prospectively to explore how patients make decisions about their health-related behaviors. This approach is comprised of a set of small tailored probable circumstances with equally plausible situations, and are presented as narrative descriptions. To understand how older adults, a group at high-risk for OTC misuse, select over-the-counter (OTC) medication qualitative methods can be used. OBJECTIVES: This study describes a scenario-based hybrid approach that included a simulation exercise and a situational interview to understand how older adults first select and then take OTC medication. METHODS: The scenario-based hybrid approach consisted of 1) a simulation exercise to emulate participants' real-world experiences as they selected a medication in a store, followed by 2) a situational interview to capture how participants intended to take the medication they selected. Video recordings captured interview data as well as participants' body language, navigation patterns, and other nuanced data that would not have been captured in audio recordings. RESULTS/CONCLUSION: The scenario-based hybrid approach not only yielded detailed information about behavior, but also allowed investigators to discern participants' decision-making, influences, and the rationales they use when selecting and taking OTC medications. Studies aiming to capture participants' behavior in naturalistic situations can use these techniques to draw inferences from direct and indirect visual references that may not be captured otherwise. In this study, the goal was to understand how older adult participants select and take OTC medications. This approach allowed the research team to expediently recreate situations in which participants would purchase an OTC medication, a task that may not occur frequently and thus may not be amenable to participant observation or accurately recalled using retrospective interviewing.
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Conductas Relacionadas con la Salud , Medicamentos sin Prescripción , Anciano , Comportamiento del Consumidor , Humanos , Estudios RetrospectivosRESUMEN
OBJECTIVE: To describe patient characteristics, adherence, and treatment patterns, among adult migraine patients in the United States prescribed erenumab. BACKGROUND: Migraine is a highly prevalent and debilitating disease characterized by recurrent attacks of moderate to severe headache accompanied by non-headache symptoms. Erenumab is a first-in-class calcitonin gene-related peptide receptor (CGRP-R) antagonist indicated for migraine prophylaxis in adults. METHODS: This retrospective longitudinal cohort study used IQVIA's open-source longitudinal pharmacy (LRx) and medical (Dx) claims databases to identify adult migraine patients with an initial claim (index date) for erenumab between May 1, 2018 and April 30, 2019. Patients were required to have ≥180 days of follow-up. Erenumab dosing patterns, persistence, and adherence (using medication possession ratio [MPR] and proportion of days covered [PDC]), and discontinuation of other commonly prescribed acute and prophylactic anti-migraine therapies were assessed. Dose changes in acute therapies after initiation of erenumab were assessed in a subset of patients with an adequate trial of erenumab (≥2 additional erenumab claims within the 80 days following the index claim). RESULTS: A total of 64,174 patients met the study criteria. Mean (SD) age was 48 (13) years and 85.2% (n = 54,656) were female. The initial erenumab dose was 70 mg for the majority of patients (65.1%; n = 41,790); most (81.4%; n = 34,019) maintained their index dose during follow-up. Overall, 30.8% (n = 19,797) of patients had a PDC ≥ 0.80 and 41.7% (n = 26,769) had a MPR ≥ 0.80. Discontinuation rates of acute and other prophylactic migraine therapies after initiation of erenumab (among users of the respective therapies) were 48.7% (22,965/47,190) and 36.1% (16,602/46,006), respectively. Dose decreases among triptan, ergot compound, opioid, and barbiturate users were observed after initiation of erenumab. CONCLUSIONS: Almost all patients had prior use of acute or preventive therapy. Adherence to erenumab was higher than traditional oral prophylactic migraine therapies; however, overall adherence was still suboptimal. The decrease in use of acute and preventive prescription medications following initiation of erenumab suggests effectiveness in the real-world setting.
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Anticuerpos Monoclonales Humanizados/uso terapéutico , Cumplimiento de la Medicación/estadística & datos numéricos , Trastornos Migrañosos/tratamiento farmacológico , Pautas de la Práctica en Medicina/estadística & datos numéricos , Adolescente , Adulto , Anciano , Antagonistas del Receptor Peptídico Relacionado con el Gen de la Calcitonina/uso terapéutico , Bases de Datos Factuales , Femenino , Humanos , Revisión de Utilización de Seguros , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Estados Unidos , Adulto JovenRESUMEN
BACKGROUND: Calcitonin gene-related peptide (CGRP) inhibitors were introduced in the United States (US) in 2018. To understand the changing patterns of preventive treatment following the introduction of these new agents, we must first characterize the patterns which preceded their introduction. OBJECTIVE: To characterize the burden, unmet need, and treatment patterns in patients with migraine initiating preventive migraine medications before the introduction of CGRP inhibitors in the US. METHODS: Between March 2016 and October 2017, we enrolled episodic (EM) and chronic migraine (CM) patients initiating or changing preventive treatment at primary care or neurology clinic visits in the US, in a real-world observational study using a prospective cohort design. At baseline and monthly thereafter for 6 months, we collected data from study sites and patients on migraine frequency, treatment modifications, migraine impact on functioning, and work productivity for a descriptive analysis of migraine patient experience and treatment patterns. RESULTS: From the sample of 234 completers, 118 had EM (50.4%) and 116 had CM (49.6%). Mean age at enrollment was 41 years (SD = 12) and mean age at first migraine diagnosis was 22 years (SD = 11). Most participants were females (n = 204/234; 87.2%) and white (n = 178/234; 76.1%). The majority (n = 164/234; 70.1%) had not used preventive migraine treatment in the 5 years prior to enrollment (treatment naïve). At baseline, mean monthly migraine days were 9.6 days (SD = 5.0) for the preventive treatment naïve group and 12.4 days (SD = 7.0) for treatment experienced patients. The majority had severe Migraine Disability Assessment (Grade IV, total score ≥21), including 67.1% (n = 110/164) of the preventive treatment naïve and 77.1% (n = 54/70) of the preventive treatment experienced patients. Headache Impact Test total scores indicating severe impairment (score >59) occurred in 88.4% (n = 145/164) of the treatment naïve and 88.6% (n = 62/70) of treatment experienced patients. Mean work productivity loss as measured by the Work Productivity and Activity Impairment questionnaire in the subsample of employed patients was 53.3% loss. The most used acute medications at baseline were nonsteroidal anti-inflammatory agents (n = 124/234; 53.0%), acetaminophen-based products (n = 112/234; 47.9%), and triptans (n = 105/234; 44.9%). The most commonly initiated preventive treatments were topiramate (n = 100/234; 42.7%), tricyclic antidepressants (n = 39/234; 16.7%), beta-blockers (n = 26/234; 11.1%), and onabotulinumtoxinA (n = 24/234; 10.3%). Over the 6-month follow-up period, almost half of patients (n = 116/234, 49.6%) modified their preventive treatment and discontinued treatment (n = 88/312 total modifications; 28.2%) or modified their pattern of use by increasing, decreasing, or skipping doses (n = 224/312 total modifications; 71.8%), often without seeking medical advice. Avoiding side effects was the main reason reported among patients who discontinued (n = 52/88; 59.1%), decreased frequency or dose (n = 37/89; 41.6%), and skipped doses (n = 29/86; 33.7%). Perceived lack of efficacy was another frequent reason reported among those who discontinued (n = 20/88; 22.7%), decreased frequency or dose (n = 15/89; 16.9%), and skipped doses (n = 18/86; 20.9%). Despite initiation of preventive treatment and improvements observed in number of headache and migraine days, migraine patients continued to experience substantial disability, headache impact, and reduced productivity throughout the 6-month follow-up period. CONCLUSIONS: Prior to 2018, the burden of migraine was high for patients initiating preventive treatments. Despite having more than 9 days of migraine per month on average, the majority (70.1%) of patients initiating prevention had been treatment naïve, indicating underuse of preventive treatments. The preventive treatments used in this study were poorly tolerated and were reported by patients to lack efficacy, resulting in suboptimal adherence. The high discontinuation rates suggest that the preventive medications being offered during the period of the study did not meet the treatment needs of patients. In addition, the decisions by about half of patients to alter their prescribed treatment plan without consulting their provider can pose substantial health risks. These findings pertain to the broad set of preventive treatments initiated in this study and do not support inferences about individual preventive treatments, due to limitations in sample size. These findings suggest the need for more effective and better tolerated preventive treatment options.