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2.
Artigo em Inglês | MEDLINE | ID: mdl-38597199

RESUMO

STUDY DESIGN: Retrospective study. OBJECTIVE: To explore the association between patients undergoing lumbar spine surgery who message their care team via an electronic patient portal (EPP) post-operatively and emergency department (ED) visits within 90 days of surgery. SUMMARY OF BACKGROUND DATA: Secure patient messaging through electronic patient portals has grown over recent years. Despite its frequent utilization by patients to engage with their care team, its association with clinical outcomes remains unknown in spine surgery. METHODS: This study was approved by our Institutional Review Board. Inclusion criteria were adults who underwent single-stage lumbar spine surgery between January 2016-June 2023. Patients with incomplete information, multi-stage surgeries, and those who died within 90 days of surgery were excluded. Patient sociodemographic, surgical, hospital readmission, and patient-provider engagement data were collected. RESULTS: A total of 13,135 patients were included. A total of 1,711 patients (13%) had a post-operative ED visit, and 4,791 patients (36%) used the patient portal to send a message after surgery. Sending a post-operative patient message after undergoing lumbar spine surgery was associated with an increased likelihood of having an ED visit that does not lead to readmission (1.29 (1.10-1.53), P = 0.002). Patients with high school degrees were more likely to have an ED visit without readmission (1.33 (1.08-1.65), P = 0.008). CONCLUSION: Patients at a higher risk of presenting to the ED post-operatively should be identified and may benefit from additional counseling and access to the care team virtually to limit unnecessary healthcare utilization. Focusing on patients who reach out via EPP messaging post-operatively may be a good target patient group to address first. Future research is needed to investigate the possible health literacy and other socioeconomic barriers affecting these patients so that appropriate, more cost-effective resources can be utilized to avoid clinically unnecessary and costly ED visits.

3.
Spine J ; 2024 Apr 24.
Artigo em Inglês | MEDLINE | ID: mdl-38663483

RESUMO

BACKGROUND CONTEXT: As value-based health care arrangements gain traction in spine care, understanding the true cost of care becomes critical. Historically, inaccurate cost proxies have been used, including negotiated reimbursement rates or list prices. However, time-driven activity-based costing (TDABC) allows for a more accurate cost assessment, including a better understanding of the primary drivers of cost in 1-level lumbar fusion. PURPOSE: To determine the variation of total hospital cost, differences in characteristics between high-cost and non-high-cost patients, and to identify the primary drivers of total hospital cost in a sample of patients undergoing 1-level lumbar fusion. STUDY DESIGN/SETTING: Retrospective, multicenter (one academic medical center, one community-based hospital), observational study. PATIENT SAMPLE: A total of 383 patients undergoing elective 1-level lumbar fusion for degenerative spine conditions between November 2, 2021 and December 2, 2022. OUTCOME MEASURES: Total hospital cost of care (normalized); preoperative, intraoperative, and postoperative cost of care (normalized); ratio of most to least expensive 1-level lumbar fusion. METHODS: Patients undergoing a 1-level lumbar fusion between November 2, 2021 and December 2, 2022 were identified at two hospitals (one quaternary referral academic medical center and one community-based hospital) within our health system. TDABC was used to calculate total hospital cost, which was also broken up into: pre-, intra-, and postoperative timeframes. Operating surgeon and patient characteristics were also collected and compared between high- and non-high-cost patients. The correlation of surgical time and cost was determined. Multivariable linear regression was used to determine factors associated with total hospital cost. RESULTS: The most expensive 1-level lumbar fusion was 6.8x more expensive than the least expensive 1-level lumbar fusion, with the intraoperative period accounting for 88% of total cost. On average. the implant cost accounted for 30% of the total, but across the patient sample, the implant cost accounted for a range of 6% to 44% of the total cost. High-cost patients were younger (55 years [SD: 13 years] vs.63 years [SD: 13 years], p=.0002), more likely to have commercial health insurance (24 out of 38 (63%) vs. 181 out of 345 (52%), p=.003). There was a poor correlation between time of surgery (i.e., incision to close) and total overall cost (ρ: .26, p<.0001). Increase age (RC: -0.003 [95% CI: -0.006 to -0.000007], p=.049) was associated with decreased cost. Surgery by certain surgeons was associated with decreased total cost when accounting for other factors (p<.05). CONCLUSIONS: A large variation exists in the total hospital cost for patients undergoing 1-level lumbar fusion, which is primarily driven by surgeon-level decisions and preferences (e.g., implant and technology use). Also, being a "fast" surgeon intraoperatively does not mean your total cost is meaningfully lower. As efforts continue to optimize patient value through ensuring appropriate clinical outcomes while also reducing cost, spine surgeons must use this knowledge to lead, or at least be active participants in, any discussions that could impact patient care.

4.
Orthop J Sports Med ; 12(3): 23259671241231608, 2024 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-38510320

RESUMO

Background: Given the variability of the questions asked, the Patient-Reported Outcomes Measurement Information System (PROMIS) upper extremity (UE) computer adaptive test (CAT) Version 2.0 item bank aids in the evaluation of rotator cuff repair (RCR) rehabilitation by determining when recovery milestones are possible based on the quality of patient responses at certain time points. Purpose: To assess the time point at which patients with RCR were able to achieve specific functional milestones, determined as positive responses to the 5 most frequently asked items on the PROMIS UE CAT Version 2.0. Study Design: Case series; Level of evidence, 4. Methods: The postoperative PROMIS UE CAT Version 2.0 scores of patients who underwent RCR between February 16, 2017, and July 30, 2019, were reviewed with respect to individual PROMIS item, response, and timing of response. A functional milestone was considered achieved if the patient response was "without any difficulty" or "with a little difficulty" to any of the 5 most frequently asked PROMIS items. The percentage of patients in each monthlong postoperative interval who answered with either response was recorded. The logit generalized estimating equations method was used to analyze the association between milestone achievement for each PROMIS item and predictor variables (age, sex, body mass index, smoking status, race, ethnicity, and employment status). Results: A total of 1131 responses from 371 patients were included. The majority of patients attained milestone achievement on 4 of the 5 most frequently asked PROMIS items at time points ranging from 1 to 5 months postoperatively: "Are you able to carry a shopping bag or briefcase?" (by 1 month), "Are you able to put on and take off a coat or jacket?" (by 3 months), "Are you able to pour liquid from a bottle into a glass?" (by 3 months), and "Are you able to carry a heavy object (over 10 pounds/5 kg)?" (by 5 months). For the item "Are you able to put on a shirt or blouse?", the majority of patients did not achieve the milestone by 1 year. Conclusion: These findings support the application of PROMIS UE CAT Version 2.0 milestone achievement in the shared decision-making process and postoperative monitoring, as patients can use this information to determine when they can return to certain activities and providers can apply these standards to identify patients needing additional clinical support.

7.
Clin Liver Dis ; 28(2): 345-358, 2024 05.
Artigo em Inglês | MEDLINE | ID: mdl-38548444

RESUMO

Hepatic encephalopathy is a strong predictor of hospital readmissions in patients with advanced liver disease. The frequent recurrence of hepatic encephalopathy and subsequent readmissions may lead to nonreversible organ dysfunction, resulting in a significant decrease of patient quality of life and increase of health care burden costs for patients and facilities. Many of these readmissions for hepatic encephalopathy are preventable. Multidisciplinary patient-centered care throughout the continuum is essential in the management of hepatic encephalopathy. Understanding the patient's daily functions and limitations in the outpatient setting is key to correctly identifying the cause of hospital admission.


Assuntos
Encefalopatia Hepática , Humanos , Encefalopatia Hepática/terapia , Encefalopatia Hepática/etiologia , Rifaximina/uso terapêutico , Readmissão do Paciente , Qualidade de Vida , Cirrose Hepática/complicações , Cirrose Hepática/terapia
8.
Artigo em Inglês | MEDLINE | ID: mdl-38307205

RESUMO

BACKGROUND: Allergic rhinitis with or without conjunctivitis can negatively impact many aspects of quality of life (QoL). The efficacy and safety of standardized quality (SQ) sublingual immunotherapy (SLIT) tablets have been confirmed across large clinical trials in adults with grass, tree, ragweed, and house dust mite (HDM) allergic rhinitis with or without conjunctivitis. OBJECTIVE: This pooled analysis investigates whether the reduction in symptom burden found across the clinical trials is supported by improvements in QoL. METHODS: A total of 11 phase II/III randomized placebo-controlled trials across the SQ grass, tree, ragweed, and HDM SLIT tablets (grass: N = 3179; ragweed: N = 767; tree: N = 634; HDM: N = 2221) were included. QoL was assessed using the standardized Rhinitis Quality of Life Questionnaire (RQLQ), with the exception of 3 grass trials, which used the nonstandardized version. The overall RQLQ scores were expressed as a mean of 7 domains. In the pooled analysis, treatment was used as fixed effect; and the trial, and the interaction between region/country and trial as random effects. RESULTS: The pooled analysis showed consistent and statistically significant improvements in overall RQLQ scores across all 4 SQ SLIT tablets versus placebo (pooled estimate [95% CI], P value-grass: -0.20 [-0.28 to -0.12], P < .001; tree: -0.42 [-0.58 to -0.26], P < .001; ragweed: -0.36 [-0.55 to -0.17], P < .001; HDM: -0.28 [-0.39 to -0.17], P < .001). Furthermore, significant improvements versus placebo for all 4 SQ SLIT tablets were seen across the 7 individual domains. CONCLUSIONS: The proven efficacy of SQ SLIT tablets to reduce symptoms across 4 of the most common respiratory allergens is supported by concurrent significant improvements in RQLQ scores overall and for all 7 domains.

9.
J Infect Dis ; 2024 Feb 07.
Artigo em Inglês | MEDLINE | ID: mdl-38324766

RESUMO

BACKGROUND: MF59-adjuvanted gB subunit (gB/MF59) vaccine demonstrated approximately 50% efficacy against human cytomegalovirus (HCMV) acquisition in multiple clinical trials, suggesting that efforts to improve this vaccine design might yield a vaccine suitable for licensure. METHODS: A messenger RNA (mRNA)-based vaccine candidate encoding HCMV gB and pentameric complex (PC), mRNA-1647, is currently in late-stage efficacy trials. However, its immunogenicity has not been compared to the partially effective gB/MF59 vaccine. We assessed neutralizing and Fc-mediated immunoglobulin G (IgG) effector antibody responses induced by mRNA-1647 in both HCMV-seropositive and -seronegative vaccinees from a first-in-human clinical trial through 1 year following third vaccination using a systems serology approach. Furthermore, we compared peak anti-gB antibody responses in seronegative mRNA-1647 vaccinees to that of seronegative gB/MF59 vaccine recipients. RESULTS: mRNA-1647 vaccination elicited and boosted HCMV-specific IgG responses in seronegative and seropositive vaccinees, respectively, including neutralizing and Fc-mediated effector antibody responses. gB-specific IgG responses were lower than PC-specific IgG responses. gB-specific IgG and antibody-dependent cellular phagocytosis responses were lower than those elicited by gB/MF59. However, mRNA-1647 elicited higher neutralization and antibody-dependent cellular cytotoxicity (ADCC) responses. CONCLUSIONS: Overall, mRNA-1647 vaccination induced polyfunctional and durable HCMV-specific antibody responses, with lower gB-specific IgG responses but higher neutralization and ADCC responses compared to the gB/MF59 vaccine. CLINICAL TRIALS REGISTRATION: NCT03382405 (mRNA-1647) and NCT00133497 (gB/MF59).

10.
J Neurosci ; 44(5)2024 Jan 31.
Artigo em Inglês | MEDLINE | ID: mdl-38296649

RESUMO

The mesolimbic dopamine system is a crucial component of reward and reinforcement processing, including the psychotropic effects of drugs of abuse such as cocaine. Drugs of abuse can activate intracellular signaling cascades that engender long-term molecular changes to brain reward circuitry, which can promote further drug use. However, gaps remain about how the activity of these signaling pathways, such as ERK1/2 signaling, can affect cocaine-induced neurochemical plasticity and cocaine-associated behaviors specifically within dopaminergic cells. To enable specific modulation of ERK1/2 signaling in dopaminergic neurons of the ventral tegmental area, we utilize a viral construct that Cre dependently expresses Map kinase phosphatase 3 (MKP3) to reduce the activity of ERK1/2, in combination with transgenic rats that express Cre in tyrosine hydroxylase (TH)-positive cells. Following viral transfection, we found an increase in the surface expression of the dopamine transporter (DAT), a protein associated with the regulation of dopamine signaling, dopamine transmission, and cocaine-associated behavior. We found that inactivation of ERK1/2 reduced post-translational phosphorylation of the DAT, attenuated the ability of cocaine to inhibit the DAT, and decreased motivation for cocaine without affecting associative learning as tested by conditioned place preference. Together, these results indicate that ERK1/2 signaling plays a critical role in shaping the dopamine response to cocaine and may provide additional insights into the function of dopaminergic neurons. Further, these findings lay important groundwork toward the assessment of how signaling pathways and their downstream effectors influence dopamine transmission and could ultimately provide therapeutic targets for treating cocaine use disorders.


Assuntos
Cocaína , Dopamina , Ratos , Animais , Dopamina/metabolismo , Neurônios Dopaminérgicos/metabolismo , Motivação , Sistema de Sinalização das MAP Quinases , Fosfatase 6 de Especificidade Dupla/metabolismo , Cocaína/farmacologia , Área Tegmentar Ventral/fisiologia , Recompensa , Ratos Transgênicos
11.
J Allergy Clin Immunol Pract ; 12(1): 85-95.e4, 2024 01.
Artigo em Inglês | MEDLINE | ID: mdl-37972922

RESUMO

BACKGROUND: There is no consensus method to identify anaphylaxis in sublingual immunotherapy (SLIT) trials. Standardized Medical Dictionary for Regulatory Activities (MedDRA) queries (SMQs) are standardized groupings of MedDRA terms used in drug safety monitoring. OBJECTIVE: To develop a method to identify potential anaphylaxis in SLIT-tablet trials using SMQ searches and case definitions of anaphylaxis adopted from the National Institute of Allergy and Infectious Disease. METHODS: The SMQ search tool contained 2 criteria including treatment-emergent adverse events (AEs): (1) narrow MedDRA terms related to anaphylaxis and (2) all AEs with broad MedDRA terms from at least 2 of 3 categories (respiratory/skin/cardiovascular) occurring on the same day. Criteria were applied to a pooled data set of all subjects from 48 timothy grass, ragweed, house dust mite, and tree SLIT-tablet trials (SLIT-tablet, N = 8200; placebo, N = 7033). Additional search strategies were any treatment-emergent AE with MedDRA preferred term "hypersensitivity" and epinephrine administrations. Identified potential cases underwent blinded independent medical expert review. Nonanaphylaxis cases were designated local AEs or mild to moderate systemic reactions. RESULTS: Using the SMQ search tool and after subsequent medical review, 8 anaphylaxis cases were identified; 3 were considered treatment-related, resulting in a proportion of anaphylaxis cases/subject of 0.02% (2 of 8200) with SLIT-tablet and 0.01% (1 of 7033) with placebo. One additional anaphylaxis case related to SLIT-tablet was identified by the preferred term "hypersensitivity." The 3 anaphylaxis cases associated with SLIT-tablet treatment were not life-threatening. The epinephrine administration rate was 17 of 8200 (0.2%) with SLIT-tablet treatment and 2 of 7033 (0.03%) with placebo. CONCLUSIONS: SMQ search criteria for identifying potential anaphylaxis related to SLIT were developed. Anaphylaxis was rare for SLIT-tablets.


Assuntos
Anafilaxia , Rinite Alérgica , Imunoterapia Sublingual , Animais , Humanos , Anafilaxia/complicações , Imunoterapia Sublingual/efeitos adversos , Imunoterapia Sublingual/métodos , Pyroglyphidae , Epinefrina , Comprimidos , Alérgenos/uso terapêutico , Rinite Alérgica/terapia , Resultado do Tratamento
12.
J Infect Dis ; 229(2): 327-340, 2024 Feb 14.
Artigo em Inglês | MEDLINE | ID: mdl-37466221

RESUMO

BACKGROUND: Influenza A (H7N9) has caused multiple disease waves with evidence of strain diversification. Optimal influenza A (H7N9) prime-boost vaccine strategies are unknown. METHODS: We recruited participants who had received monovalent inactivated A/Shanghai/2/2013 (H7N9) vaccine (MIV) approximately 5 years earlier, as follows: MIV with MF59 (MF59 × 2 group), MIV with AS03 (AS03 × 2 group), unadjuvanted MIV (No Adj group), MIV with MF59 or AS03 followed by unadjuvanted MIV (Adjx1 group), and A/H7-naive (unprimed group). Participants were randomized to receive 1 dose of AS03-adjuvanted or unadjuvanted A/Hong Kong/125/2017 (H7N9) MIV and were followed for safety and immunogenicity using hemagglutination inhibition (HAI) and neutralizing antibody assays. RESULTS: We enrolled 304 participants: 153 received the adjuvanted boost and 151 received the unadjuvanted boost. At 21 days postvaccination, the proportion of participants with HAI antibody titers against the boosting vaccine strain of ≥40 in the adjuvanted and unadjuvanted arms, respectively, were 88% and 49% in MF59 × 2 group, 89% and 75% in AS03 × 2 group, 59% and 20% in No Adj group, 94% and 55% in Adjx1group, and 9% and 11% in unprimed group. CONCLUSIONS: Serologic responses to a heterologous A(H7N9) MIV boost were highest in participants primed and boosted with adjuvant-containing regimens. CLINICAL TRIALS REGISTRATION: NCT03738241.


Assuntos
Subtipo H7N9 do Vírus da Influenza A , Vacinas contra Influenza , Influenza Humana , Humanos , Adjuvantes Imunológicos , Anticorpos Antivirais , China , Testes de Inibição da Hemaglutinação , Imunogenicidade da Vacina , Influenza Humana/prevenção & controle , Polissorbatos , Esqualeno
14.
Clin Orthop Relat Res ; 482(4): 604-614, 2024 Apr 01.
Artigo em Inglês | MEDLINE | ID: mdl-37882798

RESUMO

BACKGROUND: Geographically based social determinants of health (SDoH) measures are useful in research and policy aimed at addressing health disparities. In the United States, the Area Deprivation Index (ADI), Neighborhood Stress Score (NSS), and Social Vulnerability Index (SVI) are frequently used, but often without a clear reason as to why one is chosen over another. There is limited evidence about how strongly correlated these geographically based SDoH measures are with one another. Further, there is a paucity of research examining their relationship with patient-reported outcome measures (PROMs) in orthopaedic patients. Such insights are important in order to determine whether comparisons of policies and care programs using different geographically based SDoH indices to address health disparities in orthopaedic surgery are appropriate. QUESTIONS/PURPOSES: Among new patients seeking care at an orthopaedic surgery clinic, (1) what is the correlation of the NSS, ADI, and SVI with one another? (2) What is the correlation of Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10 physical and mental health scores and the NSS, ADI, and SVI? (3) Which geographically based SDoH index or indices are associated with presenting PROMIS Global-10 physical and mental health scores when accounting for common patient-level sociodemographic factors? METHODS: New adult orthopaedic patient encounters at clinic sites affiliated with a tertiary referral academic medical center between 2016 and 2021 were identified, and the ADI, NSS, and SVI were determined. Patients also completed the PROMIS Global-10 questionnaire as part of routine care. Overall, a total of 75,335 new patient visits were noted. Of these, 62% (46,966 of 75,335) of new patient visits were excluded because of missing PROMIS Global-10 physical and mental health scores. An additional 2.2% of patients (1685 of 75,335) were excluded because they were missing at least one SDoH index at the time of their visit (for example, if a patient only had a Post Office box listed, the SDoH index could not be determined). This left 35% of the eligible new patient visits (26,684 of 75,335) in our final sample. Though only 35% of possible new patient visits were included, the diversity of these individuals across numerous characteristics and the wide range of sociodemographic status-as measured by the SDoH indices-among included patients supports the generalizability of our sample. The mean age of patients in our sample was 55 ± 18 years and a slight majority were women (54% [14,366 of 26,684]). Among the sample, 16% (4381of 26,684) of patients were of non-White race. The mean PROMIS Global-10 physical and mental health scores were 43.4 ± 9.4 and 49.7 ± 10.1, respectively. Spearman correlation coefficients were calculated among the three SDoH indices and between each SDoH index and PROMIS Global-10 physical and mental health scores. In addition, regression analysis was used to assess the association of each SDoH index with presenting functional and mental health, accounting for key patient characteristics. The strength of the association between each SDoH index and PROMIS Global-10 physical and mental health scores was determined using partial r-squared values. Significance was set at p < 0.05. RESULTS: There was a poor correlation between the ADI and the NSS (ρ = 0.34; p < 0.001). There were good correlations between the ADI and SVI (ρ = 0.43; p < 0.001) and between the NSS and SVI (ρ = 0.59; p < 0.001). There was a poor correlation between the PROMIS Global-10 physical health and NSS (ρ = -0.14; p < 0.001), ADI (ρ = -0.24; p < 0.001), and SVI (ρ = -0.17; p < 0.001). There was a poor correlation between PROMIS Global-10 mental health and NSS (ρ = -0.13; p < 0.001), ADI (ρ = -0.22; p < 0.001), and SVI (ρ = -0.17; p < 0.001). When accounting for key sociodemographic factors, the ADI demonstrated the largest association with presenting physical health (regression coefficient: -0.13 [95% CI -0.14 to -0.12]; p < 0.001) and mental health (regression coefficient: -0.13 [95% CI -0.14 to -0.12]; p < 0.001), as confirmed by the partial r-squared values for each SDoH index (physical health: ADI 0.04 versus SVI 0.02 versus NSS 0.01; mental health: ADI 0.04 versus SVI 0.02 versus NSS 0.01). This finding means that as social deprivation increases, physical and mental health scores decrease, representing poorer health. For further context, an increase in ADI score by approximately 36 and 39 suggests a clinically meaningful (determined using distribution-based minimum clinically important difference estimates of one-half SD of each PROMIS score) worsening of physical and mental health, respectively. CONCLUSION: Orthopaedic surgeons, policy makers, and other stakeholders looking to address SDoH factors to help alleviate disparities in musculoskeletal care should try to avoid interchanging the ADI, SVI, and NSS. Because the ADI has the largest association between any of the geographically based SDoH indices and presenting physical and mental health, it may allow for easier clinical and policy application. CLINICAL RELEVANCE: We suggest using the ADI as the geographically based SDoH index in orthopaedic surgery in the United States. Further, we caution against comparing findings in one study that use one geographically based SDoH index to another study's findings that incorporates another geographically based SDoH index. Although the general findings may be the same, the strength of association and clinical relevance could differ and have policy ramifications that are not otherwise appreciated; however, the degree to which this may be true is an area for future inquiry.


Assuntos
Procedimentos Ortopédicos , Ortopedia , Adulto , Humanos , Masculino , Feminino , Pessoa de Meia-Idade , Idoso , Saúde Mental , Determinantes Sociais da Saúde , Exame Físico , Medidas de Resultados Relatados pelo Paciente
16.
Virology ; 589: 109916, 2024 01.
Artigo em Inglês | MEDLINE | ID: mdl-37925791

RESUMO

Cross-neutralizing aptamers targeting both HSV-1 and HSV-2 were developed by selecting against the ectodomains of glycoprotein D (gD) from both viruses in parallel as well as sequentially using the SELEX method. Since gD facilitates viral invasion, sterically blocking the host-receptor interaction prevents infection. Candidate aptamers were screened, and lead aptamers were identified that exhibited exceptional neutralizing activity against both viruses in vitro. The specificity of the aptamers was confirmed by comparing their activity to scrambled versions of themselves. Modifications of the lead compounds were tested to define critical motifs to guide development. Stability of the aptamers was increased using phosphorothioate backbone linkages, and 2' methoxy substitutions of terminal and key internal bases. Aptamers were applied in a guinea pig vaginal HSV-2 infection model and found to reduce both the viral load of infected animals and the severity of the resulting disease. These results suggest that cross-neutralizing aptamers can be developed into on-demand antiviral interventions effective against both HSV-1 and HSV-2.


Assuntos
Aptâmeros de Nucleotídeos , Herpesvirus Humano 1 , Feminino , Animais , Cobaias , Herpesvirus Humano 2/genética , Herpesvirus Humano 1/genética , Proteínas do Envelope Viral/genética , Anticorpos Antivirais
17.
Allergy Asthma Proc ; 45(1): 33-36, 2024 Jan 01.
Artigo em Inglês | MEDLINE | ID: mdl-38151733

RESUMO

Background: Most patients with allergic rhinitis/conjunctivitis (AR/C) are sensitized to more than one allergen. An ongoing question is the efficacy of single-allergen immunotherapy in patients who are polysensitized. Objective: To evaluate the efficacy and safety of grass, ragweed, tree, and house-dust mite (HDM) sublingual immunotherapy (SLIT) tablets in adults with AR/C who are mono- or polysensitized. Methods: Data from adults (ages ≥ 18 years) with AR/C who participated in phase III double-blind, placebo controlled field trials (four grass, two ragweed, two HDM, one tree) were included in the post hoc analyses. Efficacy was assessed by the total combined score (TCS) (sum of AR/C daily symptom and medication scores) during the entire pollen season for grass and tree trials, and peak pollen season for ragweed trials versus placebo. Efficacy for the HDM SLIT-tablet was assessed by the total combined rhinitis score (TCRS) (sum of rhinitis daily symptom and medication scores) during the last 8 weeks of treatment versus placebo. Results: For the grass SLIT-tablet, TCS improved by 20% (mean difference 1.33 [95% confidence interval {CI}, 0.44-2.22]) in the subjects who were monosensitized (n = 442) and 20% (mean difference 1.28 [95% CI, 0.90-1.67]) in the subjects who were polysensitized (n = 1857). For the ragweed SLIT-tablet, TCS improved by 19% (mean difference 1.72 [95% CI, -0.20 to 3.63]) in the subjects who were monosensitized (n = 115) and 27% (mean difference 2.27 [95% CI, 1.28-3.27]) in the subjects who were polysensitized (n = 528). For the tree SLIT-tablet, TCS improved by 54% (mean difference 4.65 [95% CI, 2.48-6.82]) in the subjects who were monosensitized (n = 138) and 34% (mean difference 2.51 [95% CI, 1.34-3.69]) in the subjects who were polysensitized (n = 437). For the HDM SLIT-tablet, TCRS improved by 20% (mean difference 1.24 [95% CI, 0.48-1.99]) in the subjects who were monosensitized (n = 468) and 17% (mean difference 0.85 [95% CI, 0.43-1.28]) in the subjects who were polysensitized (n = 1294). The overall safety profile was not qualitatively different between the subjects who were monosensitized and the subjects who were polysensitized. Conclusion: Grass, ragweed, tree, or HDM SLIT-tablet treatment is effective for the specific allergen in question in adults with AR/C and who are monosensitized or polysensitized. Targeting one relevant allergen with SLIT-tablets induces a clinical effect for that allergen in patients who were polysensitized.


Assuntos
Conjuntivite Alérgica , Conjuntivite , Rinite Alérgica , Imunoterapia Sublingual , Adulto , Animais , Humanos , Alérgenos , Ambrosia , Conjuntivite Alérgica/terapia , Dermatophagoides pteronyssinus , Poaceae , Pyroglyphidae , Rinite Alérgica/terapia , Rinite Alérgica/etiologia , Imunoterapia Sublingual/efeitos adversos , Comprimidos , Resultado do Tratamento , Método Duplo-Cego
19.
J Arthroplasty ; 2023 Dec 09.
Artigo em Inglês | MEDLINE | ID: mdl-38072097

RESUMO

BACKGROUND: Arthroplasty surgeons use a variety of patient-reported outcome measures (PROMs) to assess functional well-being, including the Knee Injury and Osteoarthritis Outcome Score (KOOS) Physical Function short form (KOOS-PS), Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Short Form 10a (PROMIS PF SF 10a), and PROMIS Global-10 Physical Health subscale. However, there is a paucity of literature assessing their concurrent validity and performance. METHODS: Between June 2016 and December 2020, patient visits at an arthroplasty clinic for knee concerns were identified. Patients who completed KOOS-PS, PROMIS PF SF 10a, and PROMIS Global-10, including its physical and mental health subscales, at the same visit were identified. Spearman rho (ρ) correlations were calculated and ceiling and floor effects identified. Overall, 5,303 patient encounters were included. RESULTS: Among physical function domains, strong correlation existed between the KOOS-PS and PROMIS PF SF 10a (ρ = 0.76, P < .001), KOOS-PS and PROMIS Global Physical Health (ρ = 0.71, P < .001), and PROMIS PF SF 10a and PROMIS Global Physical Health (ρ = 0.78, P < .001). No physical function-focused PROM had an appreciable floor effect (ie, at or more than 1%). The KOOS-PS had a small but measurable ceiling effect (n = 105 [2.0%]). CONCLUSIONS: All of the examined PROMs are acceptable to measure the functional status of patients with knee pathology, with the PROMIS Global-10 also being able to capture elements of mental health too. The PROMIS Global-10 may be of most value of the PROMs assessed, as the United States Centers for Medicare and Medicaid Services already incorporate the mental health component into new alternative payment models.

20.
Hand (N Y) ; : 15589447231211603, 2023 Nov 14.
Artigo em Inglês | MEDLINE | ID: mdl-37961854

RESUMO

BACKGROUND: The Quick Disabilities of the Arm, Shoulder, and Hand (QuickDASH) is a validated, static hand and upper extremity patient-reported outcome measure (PROM) commonly used. However, with the growth of PROM implementation across orthopedic and plastic surgery clinics, it is beneficial to determine whether a more general PROM can be used to capture the same insights. This would ease implementation broadly. There is a paucity of literature assessing whether the QuickDASH and Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10 are correlated and perform similarly. METHODS: Between June 2016 and December 2020, hand and upper extremity patients seeking care at clinics associated with a single quaternary academic medical center were identified. Those who completed the PROMIS Global-10 and QuickDASH as part of routine care were identified. The PROMIS Global-10 is divided into the PROMIS Global Physical Health and PROMIS Global Mental Health subscores. Spearman rho (ρ) correlations were calculated across PROMs, and ceiling and floor effects were determined. RESULTS: Across the 18 744 included patients, there was a strong correlation and strong-moderate correlation found between the QuickDASH and PROMIS Global Physical Health (ρ = 0.70, P < .001) and PROMIS Global Mental Health (ρ = 0.69, P < .001), respectively. Although small, QuickDASH demonstrates the worst floor effect (2.6%, [n = 478]), whereas PROMIS Global Mental Health demonstrated a much more notable ceiling effect (11%, [n = 2034]). CONCLUSIONS: The PROMIS Global-10 can be used to assess the functional status of patients presenting for hand and upper extremity concerns, while also capturing aspects of mental health. The PROMIS Global-10 may ease PROM implementation broadly.

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