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This study aimed to generate evidence to support psychometric validity of the modified functional Scale for the Assessment and Rating of Ataxia (f-SARA) among patients with spinocerebellar ataxia (SCA). Psychometric measurement properties and minimal change thresholds of the f-SARA were evaluated using data from a cohort of SCA subjects (recruited at Massachusetts General Hospital [MGH]; n = 33) and data from a phase 3 trial of troriluzole in adults with SCA (NCT03701399 [Study 206]; n = 217), including a subset of patients with the SCA3 genotype (n = 89). f-SARA item ceiling effects were absent within the MGH cohort, while floor effects were present. Excellent internal consistency reliability was demonstrated (αtotal = 0.90; αitems-removed = 0.86-0.90), and item-to-total correlations were strong (r = 0.82-0.91, per item). High test-retest reliability was demonstrated with intraclass correlation coefficients of 0.91 (total) and 0.73-0.92 (items). Convergent and divergent validity was supported, with strong correlations observed between the f-SARA and similarly constructed scales (FARS-FUNC, BARS, PROM-ADL, and FARS-ADL; all p < 0.001) and weaker correlations observed among measures of differing constructs. Mean item and total scores increased with disease severity (by FARS-FUNC quartile; p < 0.001). A 1-point threshold for meaningful changes was supported as 0.5 × SD = 0.89, SEM = 1.12, and mean changes from baseline for patients classified as "improved," "no change," or "deteriorated" were -0.68, 0.02, and 0.58, respectively. Similar trends were observed in Study 206 all-SCA and SCA3 cohorts. The measurement properties of the f-SARA provide evidence of its psychometric validity, responsiveness, and suitability as a clinical outcome measure in patients with SCA, including those with SCA3.
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Spinocerebellar ataxias (SCA) are rare inherited neurodegenerative disorders characterized by a progressive impairment of gait, balance, limb coordination, and speech. There is currently no composite scale that includes multiple aspects of the SCA experience to assess disease progression and treatment effects. Applying the method of partial least squares (PLS) regression, we developed the Spinocerebellar Ataxia Composite Scale (SCACOMS) from two SCA natural history datasets (NCT01060371, NCT02440763). PLS regression selected items based on their ability to detect clinical decline, with optimized weights based on the item's degree of progression. Following model validation, SCACOMS was leveraged to examine disease progression and treatment effects in a 48-week SCA clinical trial cohort (NCT03701399). Items from the Clinical Global Impression-Global Improvement Scale (CGI-I), the Friedreich Ataxia Rating Scale (FARS) - functional stage, and the Modified Functional Scale for the Assessment and Rating of Ataxia (f-SARA) were objectively selected with weightings based on their sensitivity to clinical decline. The resulting SCACOMS exhibited improved sensitivity to disease progression and greater treatment effects (compared to the original scales from which they were derived) in a 48-week clinical trial of a novel therapeutic agent. The trial analyses also provided a SCACOMS-derived estimate of the temporal delay in SCA disease progression. SCACOMS is a useful composite measure, effectively capturing disease progression and highlighting treatment effects in patients with SCA. SCACOMS will be a powerful tool in future studies given its sensitivity to clinical decline and ability to detect a meaningful clinical impact of disease-modifying treatments.
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BACKGROUND: The National Institutes of Health (NIH) recommends patient education materials reflect the average reading grade level of the US population. Due to the importance of shared decision-making in breast cancer surgery, this study evaluates the reading level of patient education materials from National Cancer Institute-designated cancer centers (NCI-DCC) compared with top Internet search results. METHODS: Online materials from NCI-DCC and top Internet search results on breast cancer, staging, surgical options, and pre- and postoperative expectations were analyzed using three validated readability algorithms: Simplified Measure of Gobbledygook Readability Formula, Coleman-Liau index, and Flesch-Kincaid grade level. Mean readability was compared across source groups and information subcategories using an unpaired t-test with statistical significance set at p < 0.05. Mean readability was compared using a one-way analysis of variance. RESULTS: Mean readability scores from NCI-DCC and Internet groups ranged from a 9th-12th grade level, significantly above the NIH recommended reading level of 6th-7th grade. There was no significant difference between reading levels from the two sources. The discrepancy between actual and recommended reading level was most pronounced for "surgical options" at a 10th-12th grade level from both sources. CONCLUSIONS: Patient education materials on breast cancer from both NCI-DCC and top Internet search results were written several reading grade levels higher than the NIH recommendation. Materials should be revised to enhance patient comprehension of breast cancer surgical treatment and guide patients in this important decision-making process to ultimately improve health outcomes.
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Neoplasias de la Mama , Estados Unidos , Humanos , Femenino , Neoplasias de la Mama/cirugía , National Cancer Institute (U.S.) , Comprensión , Educación del Paciente como Asunto , National Institutes of Health (U.S.) , InternetRESUMEN
OBJECTIVE: The objective of this study is to evaluate online educational resources on cleft lip and palate teams. DESIGN: A Cross-Sectional Study. SETTING: An International, Multi-Institutional Study. PARTICIPANTS: All American Cleft Palate and Craniofacial Association-approved teams with websites. INTERVENTIONS: None. MAIN OUTCOME MEASURES: Websites were assessed for patient education and support content. Affiliation between presence of materials and U.S. Newsweek Top 100 Hospitals was also assessed. RESULTS: 187 teams were included. Presence of educational videos were available in 29.4% of websites, educational infographics in 18.2%, written materials in 66.8%, perioperative instructions in 19.3%, diagnosis information in 34.8% and treatment information in 63.1%. Information on team members were available on 77.0% of websites, resources in languages other than English in 38.5%, and support group resources in 25.7%. Cleft lip and palate diagnosis information was significantly associated with geographic region, with the largest impact from the West region (P = .03). There was a significant difference between teams affiliated with U.S. Newsweek Top 100 hospitals: Top 100 hospitals had a higher presence of educational infographics, perioperative instructions, definitions, diagnosis, and treatment (P < .01). There was no significant difference between presence of educational videos (P = .37). CONCLUSION: While many websites had basic educational materials, very few included detailed information on peri-operative planning, as well as additional forms of information including videos, infographics, and non-English languages. Providing comprehensive patient education materials online is an important supplement for patients with cleft lip and palate and should be prioritized by cleft teams.
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OBJECTIVES: Evaluate the readability of online English and Spanish cleft lip and palate patient education materials. DESIGN: Review of free online materials. SETTING: English and Spanish language online patient education materials on cleft lip and palate were collected from American Cleft Palate-Craniofacial Association (ACPA) approved teams. PARTICIPANTS: American Cleft Palate-Craniofacial Association (ACPA) approved teams. INTERVENTIONS: English materials were analyzed using the Flesch-Kincaid, SMOG, and Coleman-Liau readability calculators. Spanish materials were analyzed using the Fry Graph, Fernandez Huerta, and INFLESZ calculators. A one-way analysis of variance (ANOVA) was used to test for variability between the readability tools. OUTCOMES: Readability levels were examined for both sets of materials. RESULTS: 171 (90.5%) teams provided English language materials online, with an average readability score calculated as 10.5 ± 2.9 (10th-11th grade). A total of 44 (23.2%) teams listed Spanish language materials online, with average readability score of 7.9 ± 1.2 (8th grade). ANOVA demonstrated statistically significant variability between the readability assessment tools (P < .01). CONCLUSION: Online cleft lip and palate patient education material provided by ACPA craniofacial teams were more available in English than in Spanish. Both sets of materials demonstrated readability levels above the recommended 6th-7th grade. Refining readability is associated with lowered healthcare costs and increased patient satisfaction.
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Shelter medicine appears to be popular among prospective veterinarians, but there is a shortage of veterinarians entering the field to fill available positions. The reasons for this discordance are not well understand. This study describes veterinary students' interest in shelter medicine, their perceptions of common duties, and their perceptions of employment attributes in shelter medicine, compared with those of current veterinarians. The sample included 146 first-year students, 155 final-year students, and 221 veterinarians who self-completed an online survey between September 2020 and March 2021. We found high levels of interest in shelter medicine, with 40% of first- and 43% of final-year students indicating they were likely to consider working in shelter medicine. Outreach clinics (84% of first-year students, 86% of final-year students), access-to-care clinics (82%, 83%), and loan forgiveness programs (75%, 64%) encouraged many veterinary students to consider working in shelter medicine. The risk of compassion fatigue, burnout, and stress (70%, 68%); weekend work (51%, 59%); euthanasia decision making (49%, 47%); euthanasia (43%, 41%); and expected salaries of shelter veterinarians (39%, 37%) acted as deterrents. Kruskal-Wallis H tests revealed students reported more positive ratings than veterinarians for most shelter medicine duties and employment characteristics, with moderate to strong consensus within groups. Little difference appeared between first- and final-year students. This study highlights target areas for animal shelters to boost recruitment of newly graduated veterinarians. Increasing veterinary students' exposure to shelter medicine throughout their veterinary training may also help address their concerns regarding euthanasia, salary, and quality of care.
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Educación en Veterinaria , Veterinarios , Medicina Veterinaria , Animales , Humanos , Estudios Prospectivos , Eutanasia Animal , Estudiantes , EmpleoRESUMEN
OBJECTIVE: The objective of this study was to explore patient preference for attributes of calcitonin gene-related peptide (CGRP) inhibitors for the preventive treatment of migraine and to describe differences in treatment preferences between patients. BACKGROUND: CGRP inhibitors are a novel class of migraine drugs specifically developed for the preventive treatment of migraine. Clinicians should understand patient preferences for CGRP inhibitors to inform and support prescribing choices. METHODS: Patients with migraine in the US and Germany were recruited to participate in an online discrete choice experiment (DCE) survey, which presented hypothetical treatment choices using five attributes: mode of administration, side effects, migraine frequency, migraine severity, and consistency of treatment effectiveness. Attribute selection was informed by a literature review and semi-structured patient interviews (n = 35), and evaluated using patient cognitive debriefing interviews (n = 5). RESULTS: Of 680 who consented to participate, 506 participants completed the survey and were included in the study (US = 257; Germany = 249). Overall, participants placed highest importance (preference weight, beta = 1.65, p < 0.001) on the treatment's ability to reduce the severity of migraine (mild vs. unchanged severity), followed by consistent treatment effectiveness (beta = 1.13, p < 0.001), and higher chance of reduced migraine frequency (beta = 1.00, p < 0.001). Participants preferred an oral tablet every other day (beta = 1.00, p < 0.001) over quarterly infusion, quarterly injections (p = 0.019), or monthly injection (p < 0.001). Preference for all treatment attributes were heterogeneous, and the subgroup analyses found that participants naïve to CGRP monoclonal antibody treatments had a stronger preference for oral therapy compared to those with such experience (p = 0.006). CONCLUSION: In this DCE assessing CGRP inhibitors attributes, the main driver of patient choice was treatment effectiveness, specifically reduced migraine severity, and consistent treatment effectiveness. Further, patients exhibited an overall preference for an oral tablet every other day over injectables. Patients' experience with previous treatments informs the value they place on treatment characteristics.
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Trastornos Migrañosos , Prioridad del Paciente , Humanos , Prioridad del Paciente/psicología , Péptido Relacionado con Gen de Calcitonina , Trastornos Migrañosos/tratamiento farmacológico , Trastornos Migrañosos/prevención & control , Trastornos Migrañosos/psicología , Alemania , Anticuerpos MonoclonalesRESUMEN
PURPOSE: Hospital-acquired pressure injuries (HAPIs) have significant impacts on patient morbidity and mortality, with approximately 2.5 million patients treated for pressure-related injuries annually.1 This study aimed to describe the influence of a comprehensive wound care team on HAPIs over an 8-year period. DESIGN: Retrospective cohort study. SUBJECTS AND SETTING: All inpatients at an academic public hospital system with HAPIs during the study period from May 2012 to February 2020. METHODS: Data on wound stage, location, infection, medical device location if applicable, and risk factors were recorded from medical records. A 1-way analysis of variance was performed to assess for significance of mean number of cases, National Pressure Injury Advisory Panel (NPIAP) stage on initial presentation, and mean number of medical device-related wounds by year. RESULTS: A total of 957 cases were included. The median stage of pressure injury on assessment was 2, with the mean NPIAP stage declining from 2012 to 2020 (P = .003). Thirty-three percent of pressure injuries were attributed to medical devices, most commonly endotracheal tubing. The most common site of pressure injury was the sacrum (33.6%). CONCLUSION: Creation of a comprehensive wound care team within our academic public hospital system demonstrated a significant decline in device-related and pressure injury cases over the past 8 years. The wound care team focused on frequent assessment, education, and evidence-based treatment to lower these HAPI events.
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Úlcera por Presión , Hospitales Públicos , Humanos , Pacientes Internos , Grupo de Atención al Paciente , Úlcera por Presión/epidemiología , Úlcera por Presión/prevención & control , Estudios RetrospectivosRESUMEN
BACKGROUND: The objective of this study was to describe patterns in monthly migraine days (MMD) and tablet utilization, and to estimate health-related quality of life (HRQoL) measures in patients treated as needed (PRN) with rimegepant 75 mg over 52-weeks. METHODS: Eligible subjects were adults with ≥1 year history of migraine and ≥ 6 MMD at baseline, who used rimegepant 75 mg up to once daily PRN (at their discretion) for up to 52-weeks in an open-label safety study (BHV3000-201; NCT03266588). Mean MMD were calculated at each 4-week period, along with mean monthly tablets taken. Migraine-specific quality of life (MSQv2) data were mapped to EQ-5D utilities and used to characterize HRQoL over time. A published network meta-analysis was used to characterize pain hours as well as time periods spent migraine free. RESULTS: One thousand forty four subjects were included in this post-hoc analysis. Overall mean MMD were 10.9 at baseline and decreased to 8.9 by week 52. Tablet use remained stable over the follow-up period. A total of 0.08 incremental QALYs were associated with rimegepant use. CONCLUSION: For subjects with 6 or more MMD, acute treatment of migraine attacks with rimegepant 75 mg on a PRN basis over one-year of follow-up was found to be associated with reduced MMD frequency without an increase in monthly tablet utilization, and improved HRQoL. There was no evidence of medication-related increases in MMDs when rimegepant 75 mg was used as needed for the acute treatment of migraine over 52-weeks. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT03266588 .
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Trastornos Migrañosos , Calidad de Vida , Adulto , Antagonistas del Receptor Peptídico Relacionado con el Gen de la Calcitonina , Método Doble Ciego , Humanos , Trastornos Migrañosos/tratamiento farmacológico , Piperidinas , Piridinas , Resultado del TratamientoRESUMEN
BACKGROUND: Previous research has extensively documented the impact of migraine episodes ('ictal') on patients' health-related quality of life. Few studies have looked at the impact of migraine on migraine-free days ('interictal'). This study was designed to describe interictal burden of migraine in a mixed group of people affected by migraine and to explore patient characteristics associated with interictal burden. METHODS: People with migraine in the United States (US) and Germany were recruited for a cross-sectional online survey, including a subgroup treated with calcitonin gene-related peptide (CGRP) monoclonal antibody (mAb). The survey included the Migraine Interictal Burden Scale (MIBS-4), Headache Impact Test (HIT-6), and items measuring patient demographics, clinical and treatment background. Data were analyzed using descriptive statistics and linear regression. RESULTS: Five hundred six people with migraine completed the survey (US: n = 257; Germany: n = 249), of whom 195 had taken a CGRP mAb for three or more months. Participants had a mean of 8.5 (SD = 6.4) Monthly Migraine Days (MMD) and 10.4 (SD = 7.1) Monthly Headache Days (MHD). The mean MIBS-4 score was 6.3 (SD = 3.4), with 67% reporting severe interictal burden (MIBS-4: ≥5). The mean HIT-6 score was 65.3 (SD = 6.0), with 86% reporting severe migraine impact (HIT-6: ≥60). MIBS-4 was correlated with the HIT-6 (r = 0.37), MMD and MHD (both r = 0.27). The HIT-6, MMD, MHD, CGRP mAb treatment, and depression all had an independent positive association with the MIBS-4. CONCLUSION: Two-thirds of the study sample reported substantial interictal burden. Whilst interictal burden was associated with migraine frequency and impact of migraine attacks, study results also show it represented a distinct aspect of the overall disease burden. Study findings further indicate unique associations between interictal burden and depression. A unique positive association between interictal burden and CGRP mAb treatment suggests a remaining unmet need among people affected by migraine treated with CGRP mAb.
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Péptido Relacionado con Gen de Calcitonina , Trastornos Migrañosos , Anticuerpos Monoclonales/uso terapéutico , Péptido Relacionado con Gen de Calcitonina/uso terapéutico , Estudios Transversales , Cefalea/tratamiento farmacológico , Humanos , Trastornos Migrañosos/tratamiento farmacológico , Calidad de Vida , Estados UnidosRESUMEN
BACKGROUND: The debilitating nature of migraine attacks is widely established; however, less is known about how the interictal burden (i.e., how patients are affected in-between migraine episodes) of migraine impacts on patients' health-related quality of life (HRQL). Acute and preventive treatments may lift the burden of the disease, but they often have unwanted side effects and limited effectiveness. The objective of this study was to understand the interictal burden of migraines, from the patient perspective, and to explore patient experience with migraine treatments. METHODS: Participants (n=35) with a self-reported diagnosis of migraine were recruited in the US, UK and Canada, including a subgroup of patients who had taken calcitonin gene-related peptide monoclonal antibody (CGRP mAb) treatment for at least three months. Participants completed a background questionnaire, followed by a semi-structured interview via telephone or video call. The interviews explored patients' migraine symptoms, perception of interictal burden and treatment experience. The interview transcripts were analysed using thematic analysis. RESULTS: The most reported migraine symptom was migraine pain, followed by aura, sensory sensitivity and nausea. Most participants reported interictal impact on HRQL, lifestyle changes they made to avoid triggers or in anticipation of an attack, impacts on work, career, daily activities and relationships. Emotional impacts were reported by all participants, including anger, depression, anxiety and hopelessness. Many participants who took preventive treatments reported improvements in HRQL and functioning but still experienced breakthrough attacks. Among patients who took CGRP mAbs, participants noted varying consistency of treatment effectiveness between treatment administrations. CONCLUSION: This study detailed the additional HRQL impact of migraine in-between migraine attacks and described the unmet need for effective treatment options to prevent and mitigate migraine attacks.
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Péptido Relacionado con Gen de Calcitonina , Trastornos Migrañosos , Anticuerpos Monoclonales/uso terapéutico , Péptido Relacionado con Gen de Calcitonina/uso terapéutico , Humanos , Trastornos Migrañosos/tratamiento farmacológico , Investigación Cualitativa , Calidad de Vida , Encuestas y CuestionariosRESUMEN
In 2020 Coronavirus disease (COVID-19) was identified in Australia. During the pandemic, as essential workers, hospital-based social workers have been on the frontline. This cross-sectional study examines the resilience of social workers during the COVID-19 pandemic, how the pandemic impacted on social work and lessons learnt. Hospital social workers working in three states, namely Victoria, Queensland, and New South Wales were invited to participate in an online web-based survey, providing non-identifiable demographic details and information a) relating to their proximity to COVID-19, b) their degree of resilience (CD-RISC-2), c) professional quality of life, d) perceived social support, e) physical health, f) professional and personal growth during the pandemic, and g) impacts of COVID-19 on their practice. Basic descriptive statistics were computed for variables of interest.â¯Within group, comparisons were made using paired t-tests or one-way ANOVAs for continuous variables as appropriate to investigate possible interstate differences. Regression analyses were conducted to determine which factors contribute to resilience. Social workers, during the pandemic, whether working under the constraints of lockdown or not, demonstrated high levels of resilience. These levels were similar across the three states, unaffected by the degree of infection in the community, indicating that as a group, social workers have high innate levels of resilience. This study provides an in-depth understanding of the impact of COVID-19 on hospital social workers, the long-term impact of the pandemic on social work practice, and potentially useful lessons learnt for the future.
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COVID-19 , Pandemias , COVID-19/epidemiología , Control de Enfermedades Transmisibles , Estudios Transversales , Atención a la Salud , Humanos , Calidad de Vida , Trabajadores Sociales , VictoriaRESUMEN
The University of Pennsylvania School of Veterinary Medicine first offered the elective Student Shelter Opportunities I (SSOI) course in 2016 to provide pre-clinical students with an opportunity to engage with shelter medicine and high-quality, high-volume surgery (HQHVS) concepts. The course utilized online asynchronous coursework to deliver content that was completed on a self-guided timeline by students. With most of the veterinary medical curriculum delivered in a traditional classroom format, it is important to assess learning in this unique course format. There is also limited information on educational experiences in online shelter medicine coursework. This retrospective study aimed to evaluate student learning in the asynchronous online portion of the SSOI elective course using paired pre- and post-test scores from a multiple-choice type assessment. The study investigated how students' pre-test and post-test scores compared and whether time to completion of material influenced student assessment performance. Paired assessments from 400 students were analyzed, and a statistically significant increase was found in post-test scores compared to pre-test following completion of the online coursework (p < .001). There was no significant difference in the mean change in score from pre-test to post-test for students who completed the online course material in 30 days or less compared to those who completed it in greater than 30 days. This study's findings support online asynchronous learning as an effective option to teach veterinary students and can be considered in the development of veterinary coursework, including for curricular adjustments to increase online learning during the SARS-CoV-2 pandemic.
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Curriculum , Educación a Distancia , Educación en Veterinaria , Educación en Veterinaria/métodos , Evaluación Educacional , Humanos , Estudios Retrospectivos , EstudiantesRESUMEN
Reporting bias in the literature occurs when there is selective revealing or suppression of results, influenced by the direction of findings. We assessed the risk of reporting bias in the epidemiological literature on health-related behavior (tobacco, alcohol, diet, physical activity, and sedentary behavior) and cardiovascular disease mortality and all-cause mortality and provided a comparative assessment of reporting bias between health-related behavior and statin (in primary prevention) meta-analyses. We searched Medline, Embase, Cochrane Methodology Register Database, and Web of Science for systematic reviews synthesizing the associations of health-related behavior and statins with cardiovascular disease mortality and all-cause mortality published between 2010 and 2016. Risk of bias in systematic reviews was assessed using the ROBIS tool. Reporting bias in the literature was evaluated via small-study effect and excess significance tests. We included 49 systematic reviews in our study. The majority of these reviews exhibited a high overall risk of bias, with a higher extent in health-related behavior reviews, relative to statins. We reperformed 111 meta-analyses conducted across these reviews, of which 65% had statistically significant results (P < 0.05). Around 22% of health-related behavior meta-analyses showed small-study effect, as compared to none of statin meta-analyses. Physical activity and the smoking research areas had more than 40% of meta-analyses with small-study effect. We found evidence of excess significance in 26% of health-related behavior meta-analyses, as compared to none of statin meta-analyses. Half of the meta-analyses from physical activity, 26% from diet, 18% from sedentary behavior, 14% for smoking, and 12% from alcohol showed evidence of excess significance bias. These biases may be distorting the body of evidence available by providing inaccurate estimates of preventive effects on cardiovascular and all-cause mortality.
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Enfermedades Cardiovasculares/mortalidad , Enfermedades Cardiovasculares/prevención & control , Conductas Relacionadas con la Salud , Inhibidores de Hidroximetilglutaril-CoA Reductasas/uso terapéutico , Prevención Primaria , Sesgo de Publicación , Conductas de Riesgo para la Salud , Humanos , Inhibidores de Hidroximetilglutaril-CoA Reductasas/efectos adversos , Prevención Primaria/estadística & datos numéricos , Sesgo de Publicación/estadística & datos numéricos , Factores de Riesgo , Revisiones Sistemáticas como AsuntoRESUMEN
OBJECTIVE: Rimegepant is an orally administered small-molecule calcitonin gene-related peptide (CGRP) receptor antagonist, with demonstrated efficacy in the acute treatment of migraine. Recent estimates from a single-arm trial (BHV3000-201) have also shown evidence of long-term preventive effects in monthly migraine days (MMDs) and health-related quality of life (HRQoL). This study aimed to compare MMDs and HRQoL data for oral rimegepant to those obtained in placebo-controlled trials for injectable anti-CGRP monoclonal antibodies (mAbs) galcanezumab and erenumab. METHODS: Matching-adjusted indirect comparisons (MAICs) were conducted using rimegepant subject-level data and published aggregate-level results from mAb trials. Rimegepant baseline characteristics were matched to the pooled subject characteristics from EVOLVE-I/II (galcanezumab vs. placebo; n = 1773) and STRIVE (ereumab vs. placebo; n = 955) by reweighting the rimegepant subjects to more closely match the distributions observed in these trials. To align with inclusion criteria of the mAb trials, only the subset of rimegepant subjects with a history of 4-14 MMDs were included (n = 257). Weighted mean differences were used to calculate adjusted change in MMDs, Migraine Disability Assessment Test (MIDAS) score, and Migraine-Specific Quality of Life Questionnaire version 2 (MSQv2) scores from baseline to week 12. RESULTS: When matched to the EVOLVE trials, rimegepant was superior to placebo with a mean difference in MMD change from baseline [95% confidence interval] of -1.16 [-1.80, -0.52] and was not statistically significantly different from galcanezumab 0.59 [-0.13, 1.32]. When matched to the STRIVE trial, rimegepant was superior to placebo -1.59 [-2.15, -1.03] and was not statistically significantly different from erenumab -0.06 [-0.61, 0.50]. Rimegepant showed superior MIDAS and MSQv2 results compared with placebo in both EVOLVE trials and in the STRIVE trial, no statistically significant differences from galcanezumab and erenumab regarding MIDAS, and favorable results compared with erenumab across all MSQv2 domains, while being generally similar to galcanezumab across all MSQv2 domains. CONCLUSIONS: When adjustments were made to reflect baseline characteristics in published literature, supporting data from BHV3000-201 suggest that rimegepant every other day is an effective therapy in reducing disability and MMDs and enhancing migraine-specific HRQoL. These data support the preventive benefit observed in randomized trials of rimegepant and further validate its efficacy for both acute and preventive treatment of migraine.
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Anticuerpos Monoclonales Humanizados/uso terapéutico , Trastornos Migrañosos/tratamiento farmacológico , Piperidinas/administración & dosificación , Piridinas/administración & dosificación , Administración Oral , Adulto , Péptido Relacionado con Gen de Calcitonina , Femenino , Humanos , Masculino , Persona de Mediana Edad , Trastornos Migrañosos/epidemiología , Placebos , Calidad de Vida , Encuestas y Cuestionarios , Resultado del TratamientoRESUMEN
PURPOSE: Women undergoing postmastectomy breast reconstruction face many complex choices. A myriad of online patient education materials exist to assist in decision making. Understanding of these materials, termed health literacy, affects surgical decision making and outcomes. The National Institutes of Health recommends writing patient education materials at a sixth- to seventh-grade reading level. The primary goal of this study was to assess readability of online breast reconstruction materials. METHODS AND MATERIALS: Resources were collected from every academic hospital with a plastic surgery residency program, 97 in total. These data were compared with the top nonacademic Web sites ranked by search engine results, 14 in total. Materials were analyzed using 3 validated readability assessment scales: Coleman-Liau Index, SMOG (Simplified Measure of Gobbledygook) Readability Formula, and Flesch-Kincaid Grade Level. Average readability was analyzed, and results were compared using a 1-way analysis of variance to assess for significance between the different tools and a 2-sided t test to assess for significance between academic and nonacademic readability results. RESULTS: The mean readability scores across the academic programs were a Coleman-Liau Index of 13.38 (standard Deviation [SD] 2.81, 13th to 14th grade), Flesch-Kincaid Grade Level of 13.04 (SD = 3.9, 13th grade), and SMOG Readability of 13.64 (SD = 2.99, 13th to 14th grade). For the 14 nonacademic sites, results showed a Coleman-Liau Index of 11.93 (SD = 1.14, 12th grade), Flesch-Kincaid of 11.82 (SD = 2.33, 11th to 12th grade), and SMOG Readability of 10.91 (SD = 1.79, 11th grade). One-way analysis of variance demonstrated no significant differences in mean readability scores across the 3 readability tools used (academic F = 2.7804, P = 0.06; nonacademic F = 1.14, P = 0.33). Two-tailed t test results demonstrated that there was statistical significance between readability of the academic in comparison with nonacademic search engine results (t = 2.04, P = 0.04). CONCLUSIONS: Average readability across all Web sites were much higher than the recommended reading level, at a 13th to 14th grade reading level for academic institutions, and an 11th to 12th grade for nonacademic Web sites. Plastic surgeons may contribute to improving patient understanding and perioperative outcomes through revising patient education materials.
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Neoplasias de la Mama , Alfabetización en Salud , Mamoplastia , Comprensión , Femenino , Hospitales , Humanos , Internet , Mastectomía , Educación del Paciente como AsuntoRESUMEN
ABSTRACT: Modern breast surgery was first introduced in the United States in 1962 with the use of silicone gel-filled breast implants. Over the past 6 decades, development of breast implants has been challenged by a variety of influencers including aesthetic appeal in shape, texture, and material; challenges in managing outcomes such as contracture, disease, and rupture; and public perception of risks associated with implants. In 1992, silicone breast prostheses were banned by the US Food and Drug Administration with exception for use in breast reconstruction, congenital deformities, or to replace existing implants.The ban led to heightened concerns about implants and possible disease manifestations. Knowledge of the historical evolution of breast prostheses is useful for understanding the associated risks and outcomes unique to each breast implant era. This article aimed to explore characteristics of breast implants by generation, with implications for diagnosis and assistance to modern surgical planning for novice plastic surgeons.
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Implantación de Mama , Implantes de Mama , Mamoplastia , Implantación de Mama/efectos adversos , Implantes de Mama/efectos adversos , Humanos , Mastectomía , Geles de Silicona/efectos adversos , Estados UnidosRESUMEN
BACKGROUND: Dog bite injuries cause significant preventable patient morbidity and health care expenditure in children. This study aimed to characterize the patient and healthcare burden related to pediatric dog bite injuries at a level 1 trauma center. METHODS: This is a retrospective review of 356 pediatric patients who presented to Virginia Commonwealth University Pediatric Emergency Department between July 2007 and August 2017 after sustaining dog bite injuries. Demographic information, injury details, management, outcomes, and financial information were analyzed. RESULTS: Most pediatric dog bite injuries afflicted male children (55.6%), ages 6 to 12 years (45.7%), by a household dog (36.2%). The most common offending breed was a pit bull or pit bull mix (53.0%). Infants and grade schoolers were more likely to sustain bites to the head/face (P = 0.001). Usual management consisted of primary repair (75.9%), whereas approximately 25% of the patients required advanced reconstructive techniques. Most patients healed uneventfully, but prolonged antibiotics, additional wound care, or procedures were necessary in 8.4% of the patients. Hospital charges per patient averaged US $8830.70 and tended to be higher in the younger age groups. Insurance status was statistically associated with use of conscious sedation, surgical consult placement, and surgical repair. CONCLUSIONS: Although most pediatric dog bite injuries in this study healed uneventfully from primary management in the emergency department, 25% required additional interventions. Furthermore, patient care for these injuries was associated with significant but potentially avoidable personal and financial burden to families. Our data reflect a need for safety education on animal care, behavior, and interaction.
Asunto(s)
Mordeduras y Picaduras , Traumatismos Faciales , Animales , Mordeduras y Picaduras/epidemiología , Mordeduras y Picaduras/terapia , Niño , Preescolar , Perros , Femenino , Humanos , Lactante , Masculino , Estudios Retrospectivos , Centros Traumatológicos , Virginia/epidemiologíaRESUMEN
The potential of physical activity (PA) to attenuate the effects of alcohol consumption on the risks of alcohol-related cancer mortality is unknown. We used data from participants aged 30 years and over in 10 British population-based surveys (Health Surveys for England 1994, 1997, 1998, 1999, 2003, 2004, 2006 and 2008 and the Scottish Health Surveys 1998 and 2003). Alcohol-related cancer mortality included oral cavity, throat, larynx, oesophagus, liver, colorectal, stomach and female breast (conservative definition), and additionally pancreas and lung (broad definition). Alcohol consumption was categorised into six groups based on the UK units/week: (a) never-drinkers, (b) ex-drinkers, (c) occasional drinkers, (d) within guidelines (<14 UK units/week [women]; <21 UK units/week [men]), (e) hazardous (14-35 [women]; 21-49 [men]) and (f) harmful (>35 [women]; >49 [men]). PA was categorised using two dichotomous classifications based on the lower (7.5 Metabolic Equivalent Task [MET]-hours/week) and upper (15 MET-hours/week) recommended limits. Using Cox proportional hazard models, we found a strong direct association between alcohol consumption and mortality risk of alcohol-related cancers, with a significantly higher risk among ex-drinkers (Hazard ratio [HR] = 1.46, 95% confidence interval [CI] = [1.09, 1.94]), drinkers who consumed hazardous (HR = 1.39, 95% CI = [1.06, 1.83]) and harmful amounts of alcohol (HR = 1.62, 95% CI = [1.13, 2.30]) compared to never-drinkers in the fully adjusted model. The increased mortality risks were substantially attenuated when participants in these drinking groups exercised >7.5 MET-hours/week. PA could be promoted as an adjunct risk minimisation measure for alcohol-related cancer prevention.
Asunto(s)
Consumo de Bebidas Alcohólicas/epidemiología , Ejercicio Físico , Neoplasias/mortalidad , Adulto , Anciano , Anciano de 80 o más Años , Consumo de Bebidas Alcohólicas/efectos adversos , Consumo de Bebidas Alcohólicas/mortalidad , Femenino , Encuestas Epidemiológicas , Humanos , Masculino , Persona de Mediana Edad , Neoplasias/etiología , Modelos de Riesgos Proporcionales , Reino Unido/epidemiologíaRESUMEN
Alcohol consumption is common across Western culture, despite its associations with adverse health outcomes, including cancer and cardiovascular disease (CVD). Physical activity (PA) has beneficial effects on many alcohol related outcomes, with data suggesting PA may offset the association between alcohol consumption and mortality. This study examined the joint associations of PA and alcohol on all-cause, CVD and cancer mortality. Participants were recruited between 2006 and 2010 in the United Kingdom. Alcohol consumption was categorised based on current UK guidelines (14â¯units/week). PA was categorised based on the Metabolic Task Equivalent of PA as low, moderate and high. Data were analysed using Cox proportional-hazard models. The final analysis, conducted in 2019, included 297,988 adults aged ≥40. Over an average follow-up of 6.9â¯years, 6079 deaths were recorded, including 1219 CVD deaths and 3112 cancer deaths. We observed greater point estimates for risk of all-cause mortality among low PA individuals who consumed alcohol at the same level as active individuals. For example, low PA participants who reported alcohol consumption ≥double guidelines had a greater HR (1.55, 95% CI 1.25, 1.93) than active individuals (moderate PA HR 1.21, 95% CI 0.95, 1.54; high PA HR 1.21, 95% CI 1.00, 1.46). Considering CVD, we observed a similar trend with lower point estimates of risk of mortality among active individuals. We found some evidence that PA modified the associations of alcohol and all-cause and CVD mortality in this large population sample of British adults.