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1.
Int J Pediatr Otorhinolaryngol ; 175: 111772, 2023 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-37898011

RESUMO

OBJECTIVE: Tympanostomy tube insertion in children is commonly performed under general anesthesia, but there has been increasing interest in office-based alternatives. Although initial research comparing in-office versus operating room (OR) insertion of tubes looks promising, there are scant data available on long-term outcomes. The objective of this study is to compare long-term outcomes of tympanostomy tubes placed in-office versus the OR, with emphasis on the duration of tube function. METHODS: We reviewed electronic medical records in an academic pediatric otolaryngology practice of children under age 13 years who had tubes placed in-office or the OR between 2010 and 2021. Differences in time to unilateral and bilateral tube occlusion/extrusion were compared by Kaplan-Meier survival analysis with log rank comparison. Cox regression modeling was performed to identify predictors of tube occlusion/extrusion. RESULTS: 817 children were included (473 office tubes, 344 OR tubes). Tube placement was equally successful for both groups (98.3% for office and 98.9% for OR). Comparison of Kaplan-Meier plots for time to unilateral and bilateral tube occlusion/extrusion by location showed no significant difference (P = .842 for unilateral and P = .714 for bilateral). However, regression analysis indicated a strong interaction of location with operator status (resident vs attending). Median time to unilateral occlusion/extrusion and bilateral occlusion/extrusion was shorter for OR residents compared to OR attendings (15.0 vs 19.5 months, P = .002, and 22.1 vs 32.0 months, P = .030, respectively). There was no difference in the time to unilateral or bilateral tube occlusion/extrusion between the office attending and OR attending groups (16.8 vs 19.5 months, P = .057 for unilateral, and 23.0 vs 32.0 months, P = .320 for bilateral). There was no significant difference between groups in the need for tube removal, repeat tubes, tube medialization, or post-extrusion tympanic membrane perforation. CONCLUSION: The comparable long-term outcomes found for tubes inserted in-office versus the OR, including time to occlusion/extrusion, suggest that both settings are acceptable for the procedure, with choice based primarily on parental preference, clinician experience, and shared decision making with families.


Assuntos
Otite Média com Derrame , Perfuração da Membrana Timpânica , Criança , Humanos , Lactente , Adolescente , Otite Média com Derrame/cirurgia , Salas Cirúrgicas , Ventilação da Orelha Média/métodos , Próteses e Implantes
2.
J Perinat Med ; 51(8): 1013-1018, 2023 Oct 26.
Artigo em Inglês | MEDLINE | ID: mdl-37192539

RESUMO

OBJECTIVES: To determine if 17α-hydroxyprogesterone caproate (17OHPC) or vaginal progesterone use for patients at risk for preterm birth has changed since the publication of the 17-OHPC to Prevent Recurrent Preterm Birth in Singleton Gestations (PROLONG) trial, and to assess which organizations' (Food and Drug Administration's [FDA], American College of Obstetrics and Gynecology's [ACOG] or Society of Maternal Fetal Medicine's [SMFM]) statements most influenced change. METHODS: Through a vignette-based physician survey, we sought to measure (by Likert scale) how counseling tendencies regarding 17OHPC and vaginal progesterone have changed since the PROLONG trial publication. Participants were also asked which organizations' statements most influenced change. RESULTS: With response rate of 97 % (141/145), a pre-to-post PROLONG trial comparison revealed significant changes in counseling for progesterone. Respondents were less likely to recommend 17OHPC (p<0.001) and more likely to recommend vaginal (p<0.001). The FDA statement most influenced the decision not to recommend 17OHPC for the prevention of preterm birth (r=-0.23, p=0.005). CONCLUSIONS: Providers have made significant changes in their counseling regarding progesterone use for patients at risk for preterm birth after the publication of the PRLONG trial.

3.
J Perinat Med ; 51(4): 546-549, 2023 May 25.
Artigo em Inglês | MEDLINE | ID: mdl-36420538

RESUMO

OBJECTIVES: To assess the degree to which removal of FDA' Pregnancy Categories (PC) of medications (A, B, C, and D) from labeling, affects the likelihood that providers will prescribe those medications. METHODS: Over a one-year period a convenience sample of providers was recruited into a randomized, survey-based, study. Two versions of the survey were randomly distributed; version 1 presented clinical vignettes, drug information, and PC, while version 2, presented the identical information without the PC. Respondents were asked to estimate their likelihood of prescribing the drug. A mixed linear model was constructed, with likelihood of prescription as the dependent variable, treated as interval-scaled. RESULTS: Out of 169 surveys given out, 162 (96%) were returned. Simple effects analysis showed that the presence of PC letter significantly affected the decision to prescribe category B (p<0.001) and C drugs (p=0.008) but not the A or D. Participants were significantly less likely to prescribe class B and C drugs when the letters were not available for review. These findings remained significant even when controlling for covariates (p=0.001). CONCLUSIONS: When a PC letter is absent on labeling, physicians were less likely to use category B and C drugs, the most common medications prescribed in pregnancy.


Assuntos
Prescrições de Medicamentos , Gravidez , Inquéritos e Questionários , Feminino , Humanos , Prescrições de Medicamentos/normas
4.
Ann Clin Lab Sci ; 52(4): 642-650, 2022 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-36197779

RESUMO

OBJECTIVE: Eosinophilic esophagitis (EoE) is a Th2 disease that presently is diagnosed and followed by clinical symptoms in the presence of endoscopic biopsies documenting elevated esophageal eosinophilia. To simplify clinical care, multiple studies have attempted to identify a disease specific serologic marker. None have been successful. The goal of this study was to employ custom designed Luminex multiplex bead assays to identify a reliable serologic marker for EoE. METHODS: Luminex assays were employed to measure serum levels of 11 analytes associated with EoE (IL-5, lL13, periostin, eotaxin-3, thymic stromal lymphopoietin, and immunoglobulins) in a cohort of pediatric patients consisting of active EoE (n=30), EoE in remission (n=13), and controls (n=34). RESULTS: No analyte was found to be elevated or depressed in active EoE compared to the other groups. Additionally, among the cohort with active EoE, none of the 11 analytes correlated with peak esophageal eosinophilia, endoscopic features of EoE quantitatively defined by an EoE validated endoscopic reference score (EREFS), or esophageal thickness as determined by endosonography. CONCLUSION: This is the largest prospective survey of heterogeneous markers studied in a consecutive cohort to determine whether they could diagnose or follow EoE. Although none were identified in this cohort, Luminex provides a rapid, economical tool to simultaneously screen multiple sera for proteins that are increased or decreased in disease states.


Assuntos
Esofagite Eosinofílica , Biomarcadores , Quimiocina CCL26 , Criança , Enterite , Eosinofilia , Esofagite Eosinofílica/diagnóstico , Esofagite Eosinofílica/patologia , Gastrite , Humanos , Interleucina-5 , Estudos Prospectivos
5.
J Matern Fetal Neonatal Med ; 35(25): 10086-10092, 2022 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-35749288

RESUMO

OBJECTIVE: To evaluate the predictive value of a low early glucose challenge test (GCT) in ruling out a subsequent diagnosis of gestational diabetes in the second trimester. METHODS: This was a retrospective cohort study of women at a single clinic who had a normal early GCT between 2016 and 2020. Patients who did not have repeat screening in the late second trimester were excluded. Demographic data were extracted from the record. The primary outcome was a normal GCT or glucose tolerance test in the late second trimester. Logistic regression and receiver operator curves (ROC) were performed to assess the ability of the early GCT value to predict subsequent normal glucose screening. RESULTS: Of the 532 pregnant persons with normal early GCT, 62 (11.7%) were subsequently diagnosed with gestational diabetes in the second trimester. None of the patients (N = 56), who had a GCT value less than 80 mg/dL were diagnosed with gestational diabetes in the second trimester. The prediction of subsequent normal screening using the early GCT on a ROC plot produced an area under the curve (AUC) of 0.67, 95% CI (0.60-0.74). Adding age, prior history of gestational diabetes and family history of diabetes mellitus to the prediction, only improved the AUC to 0.75, 95% CI (0.66, 0.82). CONCLUSION: Early GCT value was a fair predictor for normal second trimester glucose testing for gestational diabetes. However, high-risk patients with an early GCT value of less than 80 mg/dL may be able to forego repeat second trimester screening.


Assuntos
Diabetes Gestacional , Gravidez , Humanos , Feminino , Teste de Tolerância a Glucose , Segundo Trimestre da Gravidez , Diabetes Gestacional/diagnóstico , Estudos Retrospectivos , Glucose , Glicemia
6.
Ann Otol Rhinol Laryngol ; 131(11): 1231-1240, 2022 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-34872386

RESUMO

OBJECTIVE: As a first line treatment for pediatric obstructive sleep-disordered breathing (SDB), adenotonsillectomy (AT) has been shown to confer physiologic and neurocognitive benefits to a child. However, there is a scarcity of data on how homework performance is affected postoperatively. Our objective was to evaluate the impact of AT on homework performance in children with SDB. METHODS: Children in grades 1 to 8 undergoing AT for SDB based on clinical criteria with or without preoperative polysomnography along with a control group of children undergoing surgery unrelated to the treatment of SDB were recruited. The primary outcome of interest was the differential change in homework performance between the study group and control at follow-up as measured by the validated Homework Performance Questionnaire (HPQ-P). Adjustments were made for demographics and Pediatric Sleep Questionnaire (PSQ) scores. RESULTS: 116 AT and 47 control subjects were recruited, and follow-up data was obtained in 99 AT and 35 control subjects. There were no significant differences between the general (total) HPQ-P scores and subscale scores between the AT and control subjects at entry and there were no significant differences in the change scores (follow-up minus initial scores) between the groups. Regression modeling also demonstrated that there were no group (AT vs control) by time interactions that predicted differential improvements in the HPQ-P (P > .10 for each model) although initial PSQ score was a significant predictor of lower HPQ-P scores for all models. CONCLUSIONS: Children with SDB experienced improvement in HPQ-P scores postoperatively, but the degree of change was not significant when compared to controls. Further studies incorporating additional educational metrics are encouraged to assess the true scholastic impact of AT in children with SDB.


Assuntos
Síndromes da Apneia do Sono , Apneia Obstrutiva do Sono , Tonsilectomia , Adenoidectomia , Criança , Humanos , Polissonografia , Síndromes da Apneia do Sono/diagnóstico , Síndromes da Apneia do Sono/cirurgia , Apneia Obstrutiva do Sono/diagnóstico , Apneia Obstrutiva do Sono/cirurgia , Inquéritos e Questionários
7.
Hypertens Pregnancy ; 40(3): 254-260, 2021 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-34511004

RESUMO

Objective: To develop a predictive model for re-admission for postpartum preeclampsia (PPEC).Methods: A case-control study; cases were patients re-admitted for PPEC; controls were not re-admitted. Mixed linear modelling was used to develop a predictive model on the training set, then validated on the validation set.Results: Two-hundred-sixty-nine patients were readmitted, and matched to 538 controls. A risk calculator was developed and yielded a sensitivity and specificity for readmission of 80.9% and 53.5%, respectively.Conclusion: A predictive model using age, race, discharge blood pressures, and preeclampsia was able to predict re-admission for PPEC with a high level of sensitivity.


Assuntos
Pressão Sanguínea/fisiologia , Eclampsia/fisiopatologia , Hipertensão/epidemiologia , Readmissão do Paciente/estatística & dados numéricos , Período Pós-Parto , Pré-Eclâmpsia/diagnóstico , Adulto , Estudos de Casos e Controles , Feminino , Hospitalização , Humanos , Hipertensão/fisiopatologia , Pré-Eclâmpsia/epidemiologia , Valor Preditivo dos Testes , Gravidez , Fatores de Risco
8.
J Biophotonics ; 14(7): e202100073, 2021 07.
Artigo em Inglês | MEDLINE | ID: mdl-33788987

RESUMO

Scarring has significant esthetic and functional consequences for patients. A need exists for anti-scarring therapeutics. Light emitting diode-red light (LED-RL) has been shown to modulate skin fibrosis. The aim of this study is to evaluate the safety and efficacy of LED-RL to reduce post-operative scarring. Cutaneous Understanding of Red-light Efficacy on Scarring was a randomized, mock-controlled, single-blind, dose-ranging, split-face phase II clinical trial. Starting 1 week post-surgery, patients received LED-RL irradiation and temperature-controlled mock therapy to incision sites at fluences of 160, 320 or 480 J/cm2 , triweekly for 3 weeks. Efficacy was assessed at 1, 3 and 6-12 months. The primary endpoint was difference in scar pliability between LED-RL-treated and control sites. Secondary outcomes included Patient and Observer Scar Assessment Scale, collagen and water concentration, and adverse events. There were no significant differences in scar pliability between treated and control scars. At certain fluences, treated scars showed greater improvements in observer rating and scar pliability, reflected by greater reductions in induration, from baseline to 6 months compared to control scars. Treatment-site adverse events included blistering (n = 2) and swelling (n = 1), which were mild and resolved without sequelae. LED-RL phototherapy is safe in the early postoperative period and may reduce scarring.


Assuntos
Cicatriz , Pele , Cicatriz/prevenção & controle , Humanos , Luz , Fototerapia , Método Simples-Cego , Pele/patologia , Resultado do Tratamento
9.
Am J Perinatol ; 38(12): 1277-1280, 2021 10.
Artigo em Inglês | MEDLINE | ID: mdl-32485753

RESUMO

OBJECTIVE: This study was aimed to determine if confirmation bias affects diagnoses in obstetrics, specifically estimation of blood loss and amniotic fluid volume. STUDY DESIGN: We performed a randomized simulation-based trial. Participants went through the following three consecutive scenarios: (1) the first involved estimating the volume of blood (actually a blood-like substance) in a container at the simulation model's perineum. The actual volume was either 500 or 1,500 mL. Participants were told it was blood seen after a vaginal delivery. One group was told that the "patient" was normotensive, the other was told that the "patient" was hypotensive. (2) The second scenario involved estimation of amniotic fluid from an ultrasound picture of four quadrants, with one group told that the patient was normotensive and the other group told that the patient had chronic hypertension. (3) The third scenario was a "negative image" of the first (i.e., if they had been randomized to the 500 mL/normotensive in scenario one, then they would be presented with the 1,500 mL/hypotensive). They also filled a survey including demographics and tolerance of ambiguity and confirmation bias scales. RESULTS: From April 2018 through May 2018, a convenience sample of 85 providers was recruited. Participants were more likely to overestimate blood loss when they were told that the patient was hypotensive (p = 0.024), in comparison to when they were told the patient had normal blood pressure. They were also less likely to estimate the amniotic fluid as normal when they were told that the patient was hypertensive (p = 0.032). CONCLUSION: Confirmation bias affects estimates of blood loss and amniotic fluid.


Assuntos
Líquido Amniótico , Viés , Pessoal de Saúde , Hemorragia/diagnóstico , Adulto , Idoso , Tomada de Decisões , Diagnóstico , Feminino , Hemorragia/complicações , Humanos , Hipotensão/etiologia , Masculino , Pessoa de Meia-Idade
10.
Endosc Ultrasound ; 9(4): 259-266, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32801228

RESUMO

BACKGROUND AND OBJECTIVE: EUS has been shown in two small series to be capable of documenting increases in the total esophageal wall thickness (TWT) in children and adults with eosinophilic esophagitis (EoE). To apply EUS-derived TWT in clinical situations or in scientific investigations in pediatric EoE, measurements of esophageal TWT in children of differing ages and heights are required. MATERIALS AND METHODS: Thirty patients (18M: 12F, 7 months to 20 years and 10 months) with a history of esophageal symptoms, but no endoscopic or histologic criteria of EoE were studied using a through the scope 20 MHZ Olympus Ultrasound miniprobe UM-3R (Olympus America, Center Valley Pa 18034) through a GIF Q180 or 160 (Olympus) standard pediatric upper endoscope. The mucosa, the mucosa plus submucosa, and the TWT were measured in the mid- and distal esophagus immediately before taking diagnostic biopsies. RESULTS: Measurements from both sites showed a statistically significant increase in TWT as a function of age (P < 0.001) and height (P < 0.001), as did the individual layers. The width of the mucosa and the submucosa were equivalent and together, they contributed more than half of the entire TWT. There were no significant differences between the means of the mid- and distal esophageal measurements. A multiple regression equation that can predict TWT based on age, with 95% confidence limits, is presented. CONCLUSIONS: EUS has demonstrated that esophageal TWT in a cohort of control children correlates with height and with age and has provided insights into the organization of the esophageal wall. Esophageal TWT values obtained by EUS can now be interpreted to recognize esophageal wall thickening throughout childhood.

11.
J Pediatr Gastroenterol Nutr ; 71(3): 328-332, 2020 09.
Artigo em Inglês | MEDLINE | ID: mdl-32427654

RESUMO

OBJECTIVES: The eosinophilic esophagitis (EoE) endoscopic reference score (EREFS) was developed to analyze adults with EoE and has been successfully applied to a pediatric cohort. The present study compares EREFS in younger and older children with EoE. METHODS: The 99 patients were divided among 3 cohorts: 44 active EoE (EoE-A); 16 EoE remission (EoE-R); and 39 controls (esophageal dysfunction but <15 eos/hpf). The cohorts were then subdivided into 2 groups: younger (≤10 years) and older (>10 years) that were compared based on the composite and the individual components of their EREFS. RESULTS: EREFS identified EoE-A in all children with an area under the receiving operating characteristics curve (AUC) of 0.85, in older children with an AUC of 0.90 and in younger children with an AUC of 0.77. Mean EREFS for ≤10 years was 1.26 ±â€Š1.19 and 2.71 ±â€Š1.33 for >10 years (P < 0.01). The 3 most common findings in our entire EoE-A cohort and in both ages were furrows, edema, and exudates. EREFS in patients with EoE-A had similar specificities (0.88 vs 0.89) and positive predictive values (0.89 vs 0.91) in both ages. CONCLUSIONS: The present investigation confirms the utilization of EREFS in Pediatric EoE. Furthermore, EREFS can detect EoE and document response to treatment in both younger and older children. EREFS, however, predicted EoE in the older children with a higher sensitivity (0.89 vs 0.63) and a higher negative predictive value (0.87 vs 0.59) than was seen in the younger cohort.


Assuntos
Esofagite Eosinofílica , Adolescente , Adulto , Idoso , Membrana Celular , Criança , Esofagite Eosinofílica/diagnóstico , Esofagoscopia , Humanos , Valor Preditivo dos Testes , Índice de Gravidade de Doença
12.
Age Ageing ; 49(3): 439-445, 2020 04 27.
Artigo em Inglês | MEDLINE | ID: mdl-32043123

RESUMO

BACKGROUND: this study compares diuresis rate, sodium clearance and free water clearance (FWC) by age and time of day (nighttime vs. daytime) in subjects with and without nocturnal polyuria (NP) to determine whether these variables affect the phenotype of NP. METHODS: post hoc analysis of two prospective observational studies. Eight urine samples collected at 3-h intervals and a single blood sample were used to calculate daytime (10a/1p/4p/7p/10p) and nighttime (1a/4a/7a) diuresis rates, sodium clearance and FWC. Three mixed linear models were constructed for diuresis rate, sodium clearance and FWC using four predictor variables: NP status (present [nocturnal urine production >90 ml/h] vs. absent [≤90 ml/h]), time of day, age and study identification. RESULTS: subjects with NP experienced higher nighttime versus daytime diuresis rates, sodium clearance and FWC. Regardless of NP status, increased age was accompanied by an increase in the ratio of nighttime/daytime diuresis rate, nighttime sodium clearance and daytime sodium clearance. FWC showed a complex age effect, which was independent of time of day or NP status. CONCLUSIONS: age-related increases in nighttime/daytime diuresis rate, 24-h sodium clearance and 24-h FWC are not specific to subjects with NP. The age-related surge in either nocturnal sodium clearance or nocturnal FWC may represent the relevant substrate for behavioural or pharmacologic interventions targeting sodium diuresis or free water diuresis, respectively. Increases in FWC in older age groups may reflect impaired circadian rhythmicity of endogenous AVP or changes in responsiveness of the aged nephron to water clearance.


Assuntos
Noctúria , Poliúria , Idoso , Diurese , Humanos , Noctúria/diagnóstico , Poliúria/diagnóstico , Sódio , Água
13.
AJP Rep ; 10(1): e20-e25, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31993247

RESUMO

Objective This study evaluates the assessment of endothelial function and its prediction for preeclampsia among women with high-risk factors. Study Design A prospective cohort study of 107 pregnant women at 20 weeks or greater gestation with risk factors for developing preeclampsia. Endothelial dysfunction was assessed using peripheral arterial tonometry by generating a reactive hyperemia index (RHI) score. An index score of <1.67 was defined as endothelial dysfunction. The primary outcome was preeclampsia. Logistic regression was used to predict preeclampsia from RHI scores, body mass index, gestational age at RHI evaluation, history of preeclampsia, history of pregestational diabetes mellitus, chronic hypertension, and fetal number. A receiver operating characteristic plot was constructed to predict preeclampsia from the RHI score. Results Among 107 women, 99 had interpretable RHI scores. Among those with an abnormal RHI ( n = 61), 17 (28%) developed preeclampsia. Among women with a normal score ( n = 38), six (16%) developed preeclampsia ( p = 0.166). After logistic regression, there was no significant association. A receiver operating characteristic plot also revealed no association between RHI score and preeclampsia. Conclusion An abnormal RHI score using peripheral arterial tonometry indicating endothelial dysfunction was not predictive of developing preeclampsia in this cohort. Future studies are needed to further evaluate this relationship.

14.
Laryngoscope ; 130(9): 2256-2262, 2020 09.
Artigo em Inglês | MEDLINE | ID: mdl-31782808

RESUMO

OBJECTIVE: The Clinical Assessment Score-15 (CAS-15) has been validated as an office-based assessment for pediatric sleep-disordered breathing in otherwise healthy children. Our objective was to determine the generalizability of the CAS-15 in a multi-institutional fashion. METHODS: Five hundred and thirty children from 13 sites with suspected sleep-disordered breathing were recruited, and the investigators completed the CAS-15. Based on decisions made in the course of clinical care, investigators recommended overnight polysomnography, observation, medical therapy, and/or surgery. Two hundred and forty-seven subjects had a follow-up CAS-15. RESULTS: Mean age was 5.1 (2.6) years; 54.2% were male; 39.1% were white; and 37.0% were African American. Initial mean (standard deviation [SD]) CAS-15 was 37.3 (12.7), n = 508. Spearman correlation between the initial CAS-15 and the initial apnea-hypopnea index (AHI) was 0.41 (95% confidence interval [CI], 0.29, 0.51), n = 212, P < .001. A receiver-operating characteristic curve predicting positive polysomnography (AHI > 2) had an area under the curve of 0.71 (95% CI, 0.63, 0.80). A score ≥ 32 had a sensitivity of 69.0% (95% CI, 61.7, 75.5), a specificity of 63.4% (95% CI, 47.9, 76.6), a positive predictive value of 88.7% (95% CI, 82.1, 93.1), and a negative predictive value of 32.9% (95% CI, 23.5, 44.0) in predicting positive polysomnography. Among children who underwent surgery, the mean change (SD) score was 30.5 (12.6), n = 201, t = 36.85, P < .001, effect size = 3.1. CONCLUSION: This study establishes the generalizability of the CAS-15 as a useful office tool for the evaluation of pediatric sleep-disordered breathing. LEVEL OF EVIDENCE: 2B Laryngoscope, 130:2256-2262, 2020.


Assuntos
Polissonografia/estatística & dados numéricos , Índice de Gravidade de Doença , Síndromes da Apneia do Sono/diagnóstico , Avaliação de Sintomas/estatística & dados numéricos , Criança , Pré-Escolar , Feminino , Humanos , Masculino , Polissonografia/métodos , Valor Preditivo dos Testes , Curva ROC , Reprodutibilidade dos Testes , Sensibilidade e Especificidade , Estatísticas não Paramétricas , Avaliação de Sintomas/métodos
15.
Trials ; 20(1): 432, 2019 Jul 15.
Artigo em Inglês | MEDLINE | ID: mdl-31307501

RESUMO

BACKGROUND: Skin fibrosis is a significant global health problem that affects over 100 million people annually and has a profoundly negative impact on quality of life. Characterized by excessive fibroblast proliferation and collagen deposition, skin fibrosis underlies a wide spectrum of dermatologic conditions ranging from pathologic scars secondary to injury (e.g., burns, surgery, trauma) to immune-mediated diseases. Effective anti-scarring therapeutics remain an unmet need, underscoring the importance of developing novel approaches to treat and prevent skin fibrosis. Our in vitro data show that light emitting diode-red light (LED-RL) can modulate key cellular and molecular processes involved in skin fibrosis. In two phase I clinical trials (STARS 1 and STARS 2), we demonstrated the safety and tolerability of LED-RL at fluences of 160 J/cm2 up to 480 J/cm2 on normal human skin. METHODS/DESIGN: CURES (Cutaneous Understanding of Red-light Efficacy on Scarring) is a dose-ranging, randomized, parallel group, split-face, single-blind, mock-controlled phase II study to evaluate the efficacy of LED-RL to limit post-surgical skin fibrosis in subjects undergoing elective mini-facelift surgery. Thirty subjects will be randomly allocated to three treatment groups to receive LED-RL phototherapy or temperature-matched mock irradiation (control) to either periauricular incision site at fluences of 160 J/cm2, 320 J/cm2, or 480 J/cm2. Starting one week post-surgery (postoperative days 4-8), treatments will be administered three times weekly for three consecutive weeks, followed by efficacy assessments at 30 days, 3 months, and 6 months. The primary endpoint is the difference in scar pliability between LED-RL-treated and control sites as determined by skin elasticity and induration measurements. Secondary outcomes include clinical and photographic evaluations of scars, 3D skin imaging analysis, histological and molecular analyses, and adverse events. DISCUSSION: LED-RL is a therapeutic modality of increasing importance in dermatology, and has the potential to limit skin fibrosis clinically by decreasing dermal fibroblast activity and collagen production. The administration of LED-RL phototherapy in the early postoperative period may optimize wound healing and prevent excessive scarring. The results from this study may change the current treatment paradigm for fibrotic skin diseases and help to pioneer LED-RL as a safe, non-invasive, cost-effective, portable, at-home therapy for scars. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03795116 . Registered on 20 December 2018.


Assuntos
Cicatriz/prevenção & controle , Fototerapia/métodos , Cuidados Pós-Operatórios/métodos , Doses de Radiação , Pele/efeitos da radiação , Cicatriz/etiologia , Cicatriz/patologia , Ensaios Clínicos Fase II como Assunto , Fibrose , Humanos , New York , Fototerapia/efeitos adversos , Cuidados Pós-Operatórios/efeitos adversos , Ensaios Clínicos Controlados Aleatórios como Assunto , Método Simples-Cego , Pele/patologia , Fatores de Tempo , Resultado do Tratamento
16.
AJP Rep ; 9(2): e195-e199, 2019 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-31263629

RESUMO

Objective Multiple authors have suggested cerclage position is a determinant of "success." We assessed the interaction between cervical length (CL), cerclage height (cerH), proximal residual length (PRL), gestational age at delivery, and rate of delivery ≤ 34 weeks, in this study. Study Design Present study is a retrospective cohort study of all cerclages placed at Maimonides Medical Center from 2006 to 2016. Outcomes: gestational age at delivery and delivery before 34 weeks; predictors: PRL, cerH, CL; and indications for cerclage: history (Hx), physical exam (PE), and ultrasound (US) indicated cerclage. A general linear model was used to predict power-transformed age at delivery from cerH, CL, and indication for cerclage. Subanalyses by indication were conducted. Logistic regression was used for delivery ≤ 34 weeks. Results The cerH by indication did not reach statistical significance ( p = 0.090). When stratified by indications, the effect of cerH on age at delivery was apparent for Hx (adjusted R 2 = 0.18, p < 0.001) and PE (adjusted R 2 = 0.43, p = 0.004) cerclages but not for US cerclages (adjusted R 2 = 0.08, p = 0.206). Logistic regression predicting delivery ≤ 34 weeks ( n = 29) produced similar results. Conclusions For Hx and PE indicated cerclages, the location of the stitch may influence the timing of delivery. Specifically, the higher the cerclage, the more advanced the gestational age at delivery.

17.
Anesthesiology ; 131(2): 279-286, 2019 08.
Artigo em Inglês | MEDLINE | ID: mdl-31233409

RESUMO

BACKGROUND: Enhanced recovery protocols employ various approaches to minimize detrimental side effects of anesthetizing agents. The authors tested the hypothesis that adding low-dose dexmedetomidine to propofol for anesthesia in ambulatory colonoscopies, compared with propofol alone, would lower the propofol requirement, improve the intra-procedure hemodynamic state, and not increase time-to-discharge. METHODS: In this noninferiority, double-blind, randomized controlled trial, patients having colonoscopies received total IV anesthesia either with propofol and placebo (n = 50), or propofol and a bolus dose of dexmedetomidine, 0.3 µg/kg (n = 51). Additional propofol was administered to maintain a Bispectral Index score of 60. Following the procedure, readiness for discharge was assessed regularly using the Modified Post Anesthetic Discharge Scoring System until discharge criteria were met. The primary outcome was the percentage of patients meeting discharge criteria within 30 min from procedure end-time. RESULTS: Twenty-six of 51 (51%) patients receiving propofol-dexmedetomidine were ready for discharge by 30 min from procedure end time, compared with 44 of 50 (88%) receiving propofol (P < 0.001). Propofol consumption was lower in subjects receiving propofol-dexmedetomidine (140 µg · kg(-1) · min(-1)) compared to those receiving propofol (180 µg · kg(-1) · min(-1)) with P = 0.011. The lowest mean arterial pressure decreased further from baseline in those receiving propofol-dexmedetomidine (-30%; mean decrease -30 ±10.5 mmHg) compared to propofol (-21%; mean decrease, -22 ± 14.2 mmHg) with P = 0.003. There was no difference in incidence of bradycardia, with sustained bradycardia occurring in 3 of 51 (6%) patients receiving propofol-dexmedetomidine compared to 1 of 50 (2%) patients receiving propofol (P = 0.62). No apnea episodes requiring positive-pressure ventilation occurred in either group. CONCLUSIONS: For anesthesia in ambulatory colonoscopy, combining low-dose dexmedetomidine with propofol delayed discharge readiness and provoked hypotension compared to propofol alone.


Assuntos
Período de Recuperação da Anestesia , Colonoscopia , Dexmedetomidina/farmacologia , Hemodinâmica/efeitos dos fármacos , Alta do Paciente/estatística & dados numéricos , Propofol/farmacologia , Idoso , Anestésicos Intravenosos/farmacologia , Pressão Arterial , Pressão Sanguínea , Método Duplo-Cego , Quimioterapia Combinada , Feminino , Frequência Cardíaca , Humanos , Hipnóticos e Sedativos/farmacologia , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Fatores de Tempo
18.
J Stroke Cerebrovasc Dis ; 28(1): 44-48, 2019 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-30291031

RESUMO

BACKGROUND: QT dispersion, maximal interlead difference in QT interval on 12-lead electrocardiogram (ECG), measures cardiac repolarization abnormalities. Data are conflicting whether QT dispersion predicts adverse outcome in acute ischemic stroke (AIS) patients. Our objective is to determine if QT dispersion predicts: (1) short-term clinical outcome in AIS, and (2) stroke location (insular versus noninsular cortex). METHODS: Admission ECGs from 412 consecutive patients with acute stroke symptoms from 2 university-based stroke centers were reviewed. QT dispersion was measured. A neuroradiologist reviewed brain imaging for insular cortex involvement. Favorable clinical outcomes at discharge were modified Rankin Scale (mRS) score of 0-1, discharge National Institutes of Health Stroke Scale (NIHSS) score less than 2, and discharge to home. Multiple logistic regressions were performed for each outcome measure and to determine the association between insular infarct and QT dispersion. RESULTS: Of 145 subjects in the final analysis, median age was 65 years (interquartile range [IQR] 56-75), male patients were 38%, black patients were 68%, median QT dispersion was 78 milliseconds (IQR 59-98), and median admission NIHSS score was 4 (IQR 2-6). QT dispersion did not predict short-term clinical outcome for mRS score (odds ratio [OR] = 1.001, 95% confidence interval [CI] .99-1.01, P = .85), NIHSS at discharge (OR = .994, 95% CI .98-1.01, P = .30), or discharge disposition (OR = 1.001, 95% CI .99-1.01, P = .81). Insular cortex involvement did not correlate with QT dispersion magnitude (OR = 1.009, 95% CI .99-1.02, P = .45). CONCLUSIONS: We could not demonstrate that QT dispersion is useful in predicting short-term clinical outcome at discharge in AIS. Further, the magnitude of QT dispersion did not predict insular cortical stroke location.


Assuntos
Isquemia Encefálica/diagnóstico , Eletrocardiografia , Acidente Vascular Cerebral/diagnóstico , Idoso , Córtex Cerebral/diagnóstico por imagem , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Prognóstico , Estudos Retrospectivos
19.
Pediatr Pulmonol ; 54(1): 20-26, 2019 01.
Artigo em Inglês | MEDLINE | ID: mdl-30489041

RESUMO

OBJECTIVE: To determine asthma outcomes in children undergoing adenotonsillectomy (T&A) for treatment of sleep-disordered breathing (SDB). HYPOTHESIS: Asthmatic children will demonstrate improvement in asthma control after T&A compared to asthmatic children not undergoing surgical treatment. STUDY DESIGN: Prospective cohort. PATIENT-SUBJECT SELECTION: 80 children with diagnosed asthma, aged 4-11, undergoing T&A and 62 controls matched to the T&A subjects by age, sex, and asthma severity classification. METHODOLOGY: Parents and children completed the Childhood Asthma Control Test (C-ACT) and the Pediatric Sleep Questionnaire (PSQ). Parents were queried regarding the number of asthma exacerbations, the frequency of the use of systemic steroids, the number of emergency room visits and the number of hospitalizations in the prior 6 months. The identical questionnaires and interviews were completed 6 months after entry. RESULTS: The adjusted mean (95% CI) C-ACT score was 21.86 (20.94-22.68) at entry and 25.15 (24.55-25.71) at follow-up for the T&A group compared with 22.42 (21.46-23.28) and 23.59 (22.77-24.33) for the control group. There was a significant group by time interaction (P < 0.001). Simple effects analysis showed that group means did not differ at entry (P = 1.00) but did differ at follow-up (P = 0.006). Baseline PSQ was a significant predictor of improvement in C-ACT scores. Statistical modeling did not demonstrate significant group by time interactions for any of the asthma clinical outcomes, although these outcomes were very infrequent in both groups. CONCLUSION: Treatment of SDB improves asthma outcomes as measured by the C-ACT.


Assuntos
Adenoidectomia , Asma/complicações , Asma/cirurgia , Síndromes da Apneia do Sono/complicações , Síndromes da Apneia do Sono/cirurgia , Tonsilectomia , Estudos de Casos e Controles , Criança , Pré-Escolar , Feminino , Humanos , Masculino , Pais , Polissonografia , Estudos Prospectivos , Sono , Esteroides/uso terapêutico , Inquéritos e Questionários , Resultado do Tratamento
20.
Stroke ; 49(8): 1933-1938, 2018 08.
Artigo em Inglês | MEDLINE | ID: mdl-29976582

RESUMO

Background and Purpose- The 2015 updated US Food and Drug Administration alteplase package insert altered several contraindications. We thus explored clinical factors influencing alteplase treatment decisions for patients with minor stroke. Methods- An expert panel selected 7 factors to build a series of survey vignettes: National Institutes of Health Stroke Scale (NIHSS), NIHSS area of primary deficit, baseline functional status, previous ischemic stroke, previous intracerebral hemorrhage, recent anticoagulation, and temporal pattern of symptoms in first hour of care. We used a fractional factorial design (150 vignettes) to provide unconfounded estimates of the effect of all 7 main factors, plus first-order interactions for NIHSS. Surveys were emailed to national organizations of neurologists, emergency physicians, and colleagues. Physicians were randomized to 1 of 10 sets of 15 vignettes, presented randomly. Physicians reported the subjective likelihood of giving alteplase on a 0 to 5 scale; scale categories were anchored to 6 probabilities from 0% to 100%. A conjoint statistical analysis was applied. Results- Responses from 194 US physicians yielded 156 with complete vignette data: 74% male, mean age 46, 80% neurologists. Treatment mean probabilities for individual vignettes ranged from 6% to 95%. Treatment probability increased from 24% for NIHSS score =1 to 41% for NIHSS score =5. The conjoint model accounted for 25% of total observed response variance. In contrast, a model accounting for all possible interactions accounted for 30% variance. Four of the 7 factors accounted jointly for 58% of total relative importance within the conjoint model: previous intracerebral hemorrhage (18%), recent anticoagulation (17%), NIHSS (13%), and previous ischemic stroke (10%). Conclusions- Four main variables jointly account for only a small fraction (<15%) of the total variance related to deciding to treat with intravenous alteplase, reflecting high variability and complexity. Future studies should consider other variables, including physician characteristics.


Assuntos
Tomada de Decisão Clínica , Médicos/tendências , Acidente Vascular Cerebral/tratamento farmacológico , Inquéritos e Questionários , Terapia Trombolítica/tendências , Ativador de Plasminogênio Tecidual/administração & dosagem , Administração Intravenosa , Tomada de Decisão Clínica/métodos , Feminino , Humanos , Masculino , Acidente Vascular Cerebral/diagnóstico por imagem , Resultado do Tratamento
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