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1.
Interv Pain Med ; 3(1): 100390, 2024 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-39239503

RESUMEN

Background: Genicular nerve radiofrequency ablation (GNRFA) is a popular and effective procedure to treat arthritic knee pain. For refractory arthritic pain that fails conservative treatment, total knee arthroplasty (TKA) has been an excellent option. Unfortunately, 15-30% of people who undergo a TKA continue to experience pain and stiffness in the knee. The treatment options for post-TKA knee pain are limited. Pain providers have been trialing GNRFA on this pain condition. However, convincing evidence of its efficacy in treating post-TKA pain is still lacking. Methods: This is a retrospective study of 73 patients who had undergone genicular nerve RFA, 46 (63.01%) with osteoarthritic pain, and 27 (36.99%) with post-TKA pain. We compared the outcomes (pain relief, function, and complications) between these two groups at 3 months and 6 months after RFA. Results: Before RFA, there was no significant difference in initial pain and functional level between these two groups. After RFA, the two groups had comparable pain relief at 3 months (p = 0.68) and 6 months (p = 0.53), and similar functionality at 3 months (p = 0.36) and 6 months (p = 0.65).The overall success rate (≥50% pain relief after RFA) was 80.82%, 95% CI: 70.34%-88.22% (osteoarthritic group 80.43%, 95% CI: 66.83%-89.35%, post-TKA 81.48%, 95% CI: 63.30%-91.82%, P = 0.91) at 3-month follow-up and 56.16%, 95% CI: 44.76%-66.95% (osteoarthritic group 56.52%, 95% CI: 42.25%-69.79%, post-TKA 55.56%, 95% CI: 37.31%-72.41%, P = 0.94) at 6-month follow-up.There were no reported complications in either group. Conclusions: Genicular Nerve Radiofrequency Ablation (GNRFA) holds the potential to be equally effective for both post-TKA knee pain and osteoarthritic knee pain.

2.
CJC Open ; 6(6): 773-780, 2024 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-39022165

RESUMEN

Background: Patients with complex congenital heart disease and Fontan palliation frequently develop extracardiac disease, including hematologic abnormalities, such as lymphopenia. However, the clinical implications of this finding are poorly understood and are therefore the topic of this investigation. Methods: Patients with Fontan physiology in our centre (1999-2018) were evaluated for the presence and impact of lymphopenia. The cohort was divided into a group with lymphopenia (L) (2 consecutive absolute lymphocyte counts ≤ 1∗103 K/ µL) and a group who had never had lymphopenia (NL). Clinical characteristics and hospital admissions (762 patient-years) were evaluated. Results: In 62 adult patients with Fontan physiology (aged 34 ± 9 years; 32 women [52%]), the patients who developed lymphopenia earliest did so 8 years after Fontan completion, with up to 60% of patients developing lymphopenia by 30 years. Lymphopenia was found to be associated with portal hypertension (varices, ascites, splenomegaly, and thrombocytopenia [VAST] score)-NL: 0 (0-2) vs L: 2 (0-4), P < 0.0001). A total of 76 heart failure and 81 arrhythmia-associated admissions occurred per 1000 patient-years. At 40 years post-Fontan, the probability of a heart failure admission was higher in the L group (L: 51 [86%] vs NL: 8 [14%], P < 0.01). Conclusions: Adult patients with Fontan physiology and lymphopenia demonstrated portal hypertension and lymphatic dysfunction more commonly, perhaps suggesting that this may be a marker of Fontan congestion and early Fontan failure. Further investigation into the relationship between lymphopenia, clinical outcomes, and Fontan function is needed.


Contexte: Chez les patients atteints d'une cardiopathie congénitale complexe ayant subi une intervention de Fontan, il est fréquent de voir apparaître des maladies extracardiaques, dont des anomalies hématologiques, comme la lymphopénie. Cependant, les implications cliniques de cette observation sont mal comprises et font donc l'objet de cette étude. Méthodologie: La présence et l'impact d'une lymphopénie ont été évalués chez des patients présentant une physiologie de Fontan dans notre centre (1999-2018). La cohorte a été divisée en un groupe composé de sujets atteints de lymphopénie (L) (2 mesures consécutives du nombre absolu de lymphocytes ≤ 1 x 103 K/µL) et un groupe de sujets n'ayant jamais présenté de lymphopénie (NL). Les caractéristiques initiales et les hospitalisations (762 années-patients) ont été évaluées. Résultats: Chez 62 adultes présentant une physiologie de Fontan (âgés de 34 ± 9 ans; 32 femmes [52 %]), la lymphopénie est apparue au plus tôt 8 ans après l'intervention de Fontan, avant 30 ans chez jusqu'à 60 % des patients. La lymphopénie a été associée à l'hypertension portale (score varices, ascite, splénomégalie et thrombocytopénie [VAST]) ­ NL : 0 (0-2) vs L : 2 (0-4), p < 0,0001. Au total, il y a eu 76 hospitalisations pour insuffisance cardiaque et 81 pour arythmie pour 1000 années-patients. Quarante ans après l'intervention de Fontan, la probabilité d'une hospitalisation pour insuffisance cardiaque était plus élevée dans le groupe L que dans le groupe NL (L : 51 [86 %] vs NL : 8 [14 %], p < 0,01). Conclusions: L'hypertension portale et la dysfonction lymphatique étaient plus fréquentes chez les adultes présentant une physiologie de Fontan et une lymphopénie, ce qui laisse peut-être entendre que ce pourrait être un marqueur d'une congestion et d'une défaillance précoce du système Fontan. D'autres recherches sur le lien entre la lymphopénie, les issues cliniques et la fonction du système Fontan sont nécessaires.

3.
Int Urogynecol J ; 35(8): 1593-1598, 2024 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-38904755

RESUMEN

INTRODUCTION AND HYPOTHESIS: Obesity is increasing worldwide, and data are limited on how body mass index (BMI) affects surgical risk in pelvic organ prolapse. This study is aimed at evaluating the impact of obesity on outcomes after apical pelvic organ prolapse surgery. We hypothesize that obese patients have higher rates of postoperative complications. METHODS: This is a retrospective cohort study using the American College of Surgeons National Surgical Quality Improvement Program database from 2014 to 2018. Current Procedural Terminology codes identified subjects aged 18-89 who underwent apical prolapse repair, including vaginal colpopexy and laparoscopic or robotic sacrocolpopexy. Minor and major complications were analyzed using the World Health Organization BMI category. Regression analysis was performed to adjust for confounders. RESULTS: The total cohort was 24,718 with 15,137 vaginal colpopexy and 9,581 laparoscopic/robotic sacrocolpopexy. The average age was 60.1, 76.5% were white, 24.2% were American Society of Anesthesiologists (ASA) class 3 or 4, and 44.7% had a major medical comorbidity. Eight hundred and eighty-five patients (5.4%) experienced a minor complication, 324 (2.0%) a major complication, and 1,167 (7.2%) any complication. There was no difference in any, major, or minor complication by BMI and this persisted after adjusting for age, race, ASA class, smoking, and surgical approach. CONCLUSIONS: There is no difference in complication rates after apical prolapse surgery by BMI regardless of age, race, ASA class, smoking use, and surgical approach. Patients and surgeons should be reassured that minimally invasive apical prolapse surgery is safe, with low complication rates. Randomized controlled trials are needed to verify these findings.


Asunto(s)
Índice de Masa Corporal , Procedimientos Quirúrgicos Ginecológicos , Laparoscopía , Obesidad , Prolapso de Órgano Pélvico , Complicaciones Posoperatorias , Vagina , Humanos , Femenino , Persona de Mediana Edad , Estudios Retrospectivos , Laparoscopía/efectos adversos , Anciano , Complicaciones Posoperatorias/etiología , Complicaciones Posoperatorias/epidemiología , Adulto , Prolapso de Órgano Pélvico/cirugía , Obesidad/complicaciones , Obesidad/cirugía , Procedimientos Quirúrgicos Ginecológicos/efectos adversos , Procedimientos Quirúrgicos Ginecológicos/estadística & datos numéricos , Vagina/cirugía , Anciano de 80 o más Años , Procedimientos Quirúrgicos Robotizados/efectos adversos , Adulto Joven , Adolescente
4.
Clin Biomech (Bristol, Avon) ; 113: 106209, 2024 03.
Artículo en Inglés | MEDLINE | ID: mdl-38401319

RESUMEN

BACKGROUND: Dynamic compression plating is a fundamental type of bone fracture fixation used to generate interfragmentary compression. The goal of this study was to investigate the mechanics of the surgical application of these plates, specifically how plate prebend, screw location, fracture gap, and applied torque influence the resulting compressive pressures. METHODS: Synthetic bones with transverse fractures were fixed with locking compression plates. One side of the fracture was fixed with locking screws. On the other side of the fracture, a nonlocking screw was inserted eccentrically to induce interfragmentary compression. A pressure mapping sensor within the fracture gap was used to record the resulting pressure distribution. Plate prebends of 0 mm, 1.5 mm, and 3 mm were tested. Three locations of the eccentric screw, four levels of screw torque, and two initial fracture gap conditions also were tested. FINDINGS: With increasing plate prebend, fracture compression pressures shifted significantly toward the far cortex; however, compression force decreased (P < 0.05). The 1.5 mm prebend plate resulted in the greatest contact area. Increasing screw torque generally resulted in greater fracture compression force. The introduction of a 1 mm fracture gap at the far cortex prior to dynamic compression resulted in little or no fracture compression. INTERPRETATION: The model showed that increasing plate prebend results in an increasing shift of fracture compression pressures toward the far cortex; however, this is accompanied by decreases in compressive force. Initial fracture gaps at the far cortex can result in little or no compression.


Asunto(s)
Fracturas Óseas , Humanos , Fracturas Óseas/cirugía , Fijación Interna de Fracturas/métodos , Placas Óseas , Tornillos Óseos , Huesos , Fenómenos Biomecánicos
5.
Fertil Steril ; 121(6): 899-901, 2024 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-38331310

RESUMEN

Pilot studies, when properly designed and implemented, are an important tool that provide critical information for the development and potential success of a subsequent, larger trial. In fact, these small-scale studies are commonly used to assess the feasibility of whether a larger trial should be initiated. A popular investigator question is whether a pilot study requires a formal statistical power calculation. In general, the answer is "no"; however, the sample size needs to be justified on the basis of the goal of the pilot study.


Asunto(s)
Proyectos de Investigación , Proyectos Piloto , Tamaño de la Muestra , Humanos , Proyectos de Investigación/estadística & datos numéricos , Ensayos Clínicos como Asunto/métodos
6.
Pediatr Crit Care Med ; 25(1): e60-e61, 2024 Jan 01.
Artículo en Inglés | MEDLINE | ID: mdl-38169342
7.
PLOS Digit Health ; 3(1): e0000428, 2024 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-38206900

RESUMEN

Social and environmental determinants of health (SEDH) data in the electronic health record (EHR) can be inaccurate and incomplete. Providers are in a unique position to impact this issue as they both obtain and enter this data, however, the variability in screening and documentation practices currently limits the ability to mobilize SEDH data for secondary uses. This study explores whether providers' perceptions of clinical importance of SEDH or EHR usability influenced data entry by analyzing two relationships: (1) provider charting behavior and clinical consideration of SEDH and (2) provider charting behavior and ease of EHR use in charting. We performed a cross-sectional study using an 11-question electronic survey to assess self-reported practices related to clinical consideration of SEDH elements, EHR usability and SEDH documentation of all staff physicians, identified using administrative listserves, at Penn State Health Hershey Medical Center during September to October 2021. A total of 201 physicians responded to and completed the survey out of a possible 2,478 identified staff physicians (8.1% response rate). A five-point Likert scale from "never" to "always" assessed charting behavior and clinical consideration. Responses were dichotomized as consistent/inconsistent and vital/not vital respectively. EHR usability was assessed as "yes" or "no" responses. Fisher's exact tests assessed the relationship between charting behavior and clinical consideration and to compare charting practices between different SEDHs. Cumulative measures were constructed for consistent charting and ease of charting. A generalized linear mixed model (GLMM) compared SDH and EDH with respect to each cumulative measure and was quantified using odds ratios (OR) and 95% confidence intervals (CI). Our results show that provider documentation frequency of an SEDH is associated with perceived clinical utility as well as ease of charting and that providers were more likely to consistently chart on SDH versus EDH. Nuances in these relationships did exist with one notable example comparing the results of smoking (SDH) to infectious disease outbreaks (EDH). Despite similar percentages of physicians reporting that both smoking and infectious disease outbreaks are vital to care, differences in charting consistency and ease of charting between these two were seen. Taken as a whole, our results suggest that SEDH quality optimization efforts cannot consider physician perceptions and EHR usability as siloed entities and that EHR design should not be the only target for intervention. The associations found in this study provide a starting point to understand the complexity in how clinical utility and EHR usability influence charting consistency of each SEDH element, however, further research is needed to understand how these relationships intersect at various levels in the SEDH data optimization process.

9.
J Trauma Acute Care Surg ; 95(5): 672-678, 2023 11 01.
Artículo en Inglés | MEDLINE | ID: mdl-37478341

RESUMEN

BACKGROUND: Uncontrolled hemorrhage is the leading cause of preventable death in combat and civilian trauma. Efficacious hemostatic agents in junctional hemorrhage can quell blood loss and improve survival. We hypothesized that a novel hemostatic foam of starch and chitosan would improve hemostasis, and thereby increase survival in a swine femoral artery hemorrhage model when compared with CombatGauze (CG). METHODS: A novel hemostatic foam of starch and chitosan was created and modified during the study period. Thirty pigs (four excluded) were assigned to treatment using either foam version 1 (FV1, n = 9) or 2 (FV2, n = 8), or (n = 9) in a standard swine femoral artery hemorrhage model. Animals were observed for 150 minutes. Outcomes assessed included hemostasis, survival, posttreatment blood loss, IV fluid volume, and hemodynamic and laboratory trends. RESULTS: Hemostasis prior to 150 minutes was similar with 44.4%, 77.8%, and 50% of swine treated with CG, FV1 and FV2, respectively (Kaplan-Meyer and log-rank test [KM-LR] p > 0.05). Survival to 150 minutes was improved in swine treated with FV1 (100%) compared with CG (55.6%) (KM-LR p = 0.02). Survival was similar between FV1 and FV2 (75%) (KM-LR p > 0.05), and between CG and FV2 (KM-LR p > 0.05). Using mixed model for longitudinal data, mean arterial pressure decreased significantly in CG- and FV2-treated swine, while there was no significant change in mean arterial pressure in FV1-treated swine. Trends in lactic acid, hematocrit, platelets, INR, and thrombelastography were more favorable for FV1 compared with CG. CONCLUSION: In this preclinical study of junctional hemorrhage, survival was improved in swine treated with version 1 of a novel chitosan/starch foam compared with CG. Trends in hemodynamics and laboratory data were also more favorable in the FV1-treated swine. This novel hemostatic foam may be an effective alternative to current hemostatic agents.


Asunto(s)
Quitosano , Hemostáticos , Porcinos , Animales , Hemostáticos/farmacología , Hemostáticos/uso terapéutico , Arteria Femoral/lesiones , Polielectrolitos , Hemorragia/etiología , Hemostasis , Almidón
11.
Data Brief ; 48: 109144, 2023 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-37383763

RESUMEN

Postoperative opioid prescribing has historically lacked information critical to balancing the pain control needs of the individual patient with our professional responsibility to judiciously prescribe these high-risk medications. This data evaluates pain control, satisfaction with pain control, and opioid utilization among patients undergoing isolated mid-urethral sling (MUS) randomized to one of two different opioid prescribing regimens. This study was registered on clinicaltrials.gov (NCT04277975). Women undergoing isolated MUS by a Female Pelvic Medicine and Reconstructive Surgery physician at a Penn State Health hospital from June 1, 2020 to November 22, 2021 were offered enrollment into this prospective, randomized, open-label, non-inferiority clinical trial. Participants gave informed consent and were enrolled by a member of the study team. Allocation was concealed to patient and study personnel until randomization on the day of surgery. Preoperatively, all participants completed baseline demographic and pain surveys including CSI-9, PCS, and Likert pain score (scale 0-10). Participants were randomized to either receive a standard prescription of ten 5 mg tablets oxycodone provided preoperatively (standard) or opioid prescription provided only upon patient request postoperatively (restricted). Randomization was performed by the study team surgeon using the REDCap randomization module on the day of surgery. Following MUS, subjects completed a daily diary for 1 week, i.e., postoperative day (POD) 0 through 7. Within the dairy, subjects provided the following information: average daily pain score, opioid use and amount of opioid utilized, other forms of pain management, satisfaction with pain control, perception of the amount of opioid prescribed, and need for pain management hospital/clinic visits. The online Prescription Drug Monitoring Program (PDMP) was queried for all patients to determine if prescriptions for opioids were filled during the postoperative period. The primary outcome was average postoperative day 1 pain score and an a priori determined margin of non-inferiority was set at 2 points. Secondary outcomes included whether subject filled an opioid prescription (indicated by the online PDMP), opioid use (yes/no), satisfaction with pain control (on a scale of 1= "much worse" to 5= "much better" than expected), and how subjects felt about the amount of opioid prescribed (on a scale of 1="prescribed far more" to 3="prescribed the right amount" to 5="prescribed far less" opioid than needed). 82 participants underwent isolated MUS placement and met inclusion criteria; 40 were randomized to the standard arm and 42 to the restricted group. Within this manuscript, we detail the data obtained from this randomized clinical trial and the methods utilized.

12.
Pediatr Crit Care Med ; 24(8): 662-669, 2023 08 01.
Artículo en Inglés | MEDLINE | ID: mdl-37102713

RESUMEN

OBJECTIVES: To investigate outcomes associated with conventional roller or centrifugal pumps during neonatal venovenous extracorporeal membrane oxygenation (ECMO). Our primary hypothesis is that in comparison with conventional roller-pump support, centrifugal pump use is associated with greater odds of survival. Our secondary hypothesis is that centrifugal pump use is associated with lesser odds of complications. DESIGN: Retrospective cohort identified using the Extracorporeal Life Support Organization (ELSO) registry 2016 to 2020 dataset. SETTING: All ECMO centers reporting to the ELSO registry. PATIENTS: All neonates (≤ 28 d) supported with venovenous ECMO and cannulated via right internal jugular vein using dual-lumen venovenous cannulas and polymethyl pentene membrane oxygenators. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: A total of 612 neonates (centrifugal, n = 340; conventional roller, n = 272) were included in the analysis. Using a multivariable logistic regression model, centrifugal pump use-as opposed to roller pump use-was associated with lesser odds of survival (odds ratio [OR], 0.53; 95% CI, 0.33-0.84; p < 0.008). Thrombosis and clots in the circuit components were also associated with lesser odds of survival (OR, 0.28; 95% CI, 0.16-0.60; p < 0.001). We failed to show that hemolysis was an independent variable for survival (OR, 0.60; 95% CI, 0.31-1.19; p = 0.14). The primary diagnosis of neonatal aspiration/meconium aspiration is associated with more than seven-fold greater odds of survival (OR, 7.57; 95% CI, 4.02-15.74; p < 0.001). CONCLUSIONS: Contrary to our hypotheses, conventional roller pump use was associated with greater odds of survival. While thrombosis and clots in circuit components were independent variables for lesser odds of survival, further research is needed better to understand the use of centrifugal pumps in neonatal practice.


Asunto(s)
Oxigenación por Membrana Extracorpórea , Síndrome de Aspiración de Meconio , Femenino , Humanos , Recién Nacido , Oxigenación por Membrana Extracorpórea/efectos adversos , Estudios Retrospectivos , Oxigenadores de Membrana , Morbilidad
13.
Fertil Steril ; 119(6): 904-906, 2023 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-37121566
14.
F S Rep ; 4(1): 121-126, 2023 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-36959970

RESUMEN

Objective: To determine the feasibility, safety, and outcomes of an oil-based, iodinated contrast using office-based, ultrasound-imaged hysterosalpingography in women with infertility. Design: Randomized Controlled Double Blind Clinical Trial. Setting: Academic health center. Interventions: Tubal flushing with oil-based contrast medium (Lipiodol UF) versus saline. Main Outcome Measures: Ongoing pregnancy rate, pain, quality of life, and thyroid function. Results: Forty-eight patients (24 in each group) were analyzed. The groups were well-matched at baseline. Ongoing pregnancy was noted in 17% (4/24) of the oil-contrast group versus 37% (9/24) in the saline group. Saline group patients more frequently initiated infertility therapy in the six-month follow-up period (saline, 67% vs. oil, 33%), and no serious adverse events in either group. There were no differences in pain from the procedure between groups. There were no differences in thyroid function tests postprocedure between groups, but within the oil-contrast group, there was a slight increase in thyroid-stimulating hormone (post vs. preratio of geometric means: 1.18; 95% confidence interval [CI], 1.02-1.38) and decrease in Free T4 (postdifference vs. predifference in means: 0.08 ng/dL; 95% CI, -0.14 to -0.01). Immediately after the test, the physicians correctly guessed 79% of oil and 71% of saline randomization assignments, whereas patients correctly guessed 63% of oil and 38% of saline. Conclusions: This pilot study demonstrates the safety and feasibility of giving an oil-based contrast medium during ultrasound-imaged hysterosalpingography. Pregnancies were seen after oil-based administration, and this contrast is associated with minor thyroid function impairment.

15.
Interv Pain Med ; 2(2): 100253, 2023 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-39238670

RESUMEN

Background: Genicular nerve radiofrequency ablation (RFA) is an effective procedure to alleviate knee pain. This procedure has been proven to be safe, except in the inferior lateral quadrant (ILQ) due to its innervation being near the common fibular nerve (CFN). Given the complexity of this approach, pain physicians do not routinely perform RFA in the ILQ, leading to inadequate pain relief in this region. Methods: This is a retrospective study of 54 patients who had undergone genicular nerve RFA. Thirty patients had genicular nerve RFA of the knee joint including the ILQ innervated by the inferolateral genicular and recurrent fibular nerves, while 24 patients had RFA of the knee joint without involvement of the ILQ. We compared the outcomes (pain relief, function, and complications) in the patients with and without ILQ RFA at 3 months and 6 months after RFA. Results: There was no significant difference in initial pain and functional level before RFA between these two groups. After RFA, the two groups had comparable pain relief at 3 months (p â€‹= â€‹0.06) and 6 months (p â€‹= â€‹0.20), and similar functionality at 3 months (p â€‹= â€‹0.29) and 6 months (p â€‹= â€‹0.12). There were no reported complications after RFA with or without ILQ RFA. Conclusions: RFA of the innervation to the ILQ of the knee is as safe and effective as all other anterior quadrants.

16.
JTCVS Open ; 16: 786-800, 2023 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-38204706

RESUMEN

Objective: The objective of this retrospective review was to evaluate whether or not pulsatile flow improves cerebral hemodynamics and clinical outcomes in pediatric congenital cardiac surgery patients. Methods: This retrospective study included 284 pediatric patients undergoing congenital cardiac surgery with cardiopulmonary bypass support utilizing nonpulsatile (n = 152) or pulsatile (n = 132) flow. Intraoperative cerebral gaseous microemboli counts, pulsatility index, and mean blood flow velocity at the right middle cerebral artery were assessed using transcranial Doppler ultrasound. Clinical outcomes were compared between groups. Results: Patient demographics and cardiopulmonary bypass characteristics between groups were similar. Although the pulsatility index during aortic crossclamping was consistently higher in the pulsatile group (P < .05), a significant degree of pulsatility was also observed in the nonpulsatile group. No significant differences in mean cerebral blood flow velocity, regional cerebral oxygen saturation, or gaseous microemboli counts were observed between the perfusion modality groups. Clinical outcomes, including intubation duration, intensive care unit and hospital length of stay, and mortality within 180 days were similar between groups. Conclusions: Although the pulsatility index was greater in the pulsatile group, other measures of intraoperative cerebral perfusion and short-term outcomes were similar to the nonpulsatile group. These findings suggest that while pulsatile perfusion represents a safe modality for cardiopulmonary bypass support, its use may not translate into detectably superior clinical outcomes.

17.
Womens Health Issues ; 32(6): 557-563, 2022.
Artículo en Inglés | MEDLINE | ID: mdl-36075817

RESUMEN

INTRODUCTION: We analyzed the exclusion of pregnant and breastfeeding individuals and those capable of pregnancy in COVID-19 vaccine and clinical treatment trials. METHODS: Inclusion and exclusion criteria were extracted from all listed COVID-19 vaccine and treatment clinical trials from May 1, 2020, to October 31, 2020, using the U.S. National Library of Medicine database. We report rates of rates of exclusion for pregnant and lactating individuals and requirements for contraception for pregnancy-capable participants in COVID-19 vaccine and treatment clinical trials. The analysis included the association between clinical trial exclusion and vaccine and treatment type, study location, sponsor, and phase. RESULTS: Pregnant and lactating individuals were explicitly excluded from most COVID-19 vaccine and treatment clinical trials. Of the 90 vaccine trials, 88 (97.8%) excluded pregnant individuals, 73 (81.1%) excluded lactating individuals, and 56 (62.2%) required contraception use. Of the 495 treatment trials, 350 (70.7%) excluded pregnant individuals, 269 (54.3%) excluded lactating individuals, and 91 (18.4%) required contraception use. Although vaccine type was not associated with pregnancy exclusion, it was associated with lactation exclusion (p = .01) and contraception requirement (p < .001). Treatment type was associated with pregnancy exclusion, lactation exclusion, and contraception requirement (all p < .001). CONCLUSIONS: COVID-19 vaccination and treatment clinical trials mirrored historical trends restricting participation owing to pregnancy, lactation, and contraception nonuse, despite known safety profiles. People of childbearing potential should be considered for and afforded the same opportunity as males to make informed decisions on study participation, particularly in the setting of a global pandemic.


Asunto(s)
COVID-19 , Vacunas , Estados Unidos/epidemiología , Embarazo , Masculino , Femenino , Humanos , Adulto , Vacunas contra la COVID-19/uso terapéutico , SARS-CoV-2 , COVID-19/epidemiología , COVID-19/prevención & control , Vacunación
18.
J Matern Fetal Neonatal Med ; 35(26): 10253-10261, 2022 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-36178153

RESUMEN

OBJECTIVE: The primary objective of this study was to report surgical outcomes for cesarean delivery (CD) patients following the implementation of an Enhanced Recovery after Surgery (ERAS) pathway based on the ERAS Society recommendations. The primary outcome for which the study was powered was the length of stay (LOS). METHODS: This IRB-approved cohort study was conducted at a single tertiary-care labor and delivery unit and utilized a pre-post intervention design. Our ERAS for CD protocol was designed using the ERAS Society recommendations and implemented globally for every patient admitted to the labor and delivery unit including both scheduled and unscheduled cases. The study was designed to have at least 85% power to detect a 6-h difference in length of stay (LOS) between the pre-intervention and post-intervention cohorts, assuming a standard deviation of 18 h. A total of 339 records were included for data analysis, 170 in the pre-intervention cohort and 169 in the post-intervention cohort. To assess the difference between groups with respect to the primary outcome of LOS, linear regression was used with and without adjusting for covariates. Differences in dichotomous secondary outcomes were assessed using binary logistic regression. Differences in continuous secondary outcomes were assessed via a two-sample t-test or Wilcoxon rank sum test. Individual components of protocol adherence were compared using chi-square tests. RESULTS: Mean LOS was 80.5 ± 22.9 h and 82.3 ± 28.0 h, pre- and post-intervention respectively. There was no difference in LOS between the 2 cohorts (difference of means = 1.8 h; 95% confidence interval (CI): (-3.7, 7.3); p = .51). Cesarean procedure infection decreased from 11.8% pre-intervention to 5.3% post-intervention, corresponding to a 58% decrease in odds of cesarean procedure infection (odds ratio (OR)=0.42; 95% CI: (0.19, 0.96); p = .04). Inpatient opioid use also significantly decreased in the post-intervention cohort with a median MME per 12 h-period of 5.1 (25th percentile = 2.2, 75th percentile = 7.8) pre-intervention and 3.3 (25th percentile = 1.0, 75th percentile = 7.6) post-intervention (p = .04). CONCLUSION: The results of this study support the implementation of an ERAS for CD protocol based on ERAS Society recommendations as evidenced by the statistically significant decrease observed in both procedure-related infection rates and inpatient opioid use. We did not find a significant difference in LOS, which leaves room for further investigation into factors that impact LOS after CD.


Asunto(s)
Analgésicos Opioides , Cesárea , Embarazo , Femenino , Humanos , Estudios de Cohortes , Tiempo de Internación , Estudios Retrospectivos , Cesárea/efectos adversos
19.
Am J Sports Med ; 50(12): 3299-3307, 2022 10.
Artículo en Inglés | MEDLINE | ID: mdl-35993448

RESUMEN

BACKGROUND: The preferred method of fixation and surgical treatment for ligamentous Lisfranc injuries is controversial. Transarticular screws, bridge plating, fusion, and flexible fixation have been described, yet none have demonstrated superiority. Furthermore, screw fixation and plating often require secondary surgery to remove implants, leading surgeons to seek alternative fixation methods. PURPOSE: To compare transarticular screws and a fiber tape construct under a spectrum of biomechanical loads by evaluating the diastasis at 3 joints in the Lisfranc complex. STUDY DESIGN: Controlled laboratory study. METHODS: Eight matched pairs of fresh, previously frozen lower extremity cadaveric specimens were fixed with either 2 cannulated transarticular crossed screws or a fiber tape construct with a supplemental intercuneiform limb. The diastasis between bones was measured at 3 midfoot joints in the Lisfranc complex: the Lisfranc articulation, the second tarsometatarsal joint, and the intercuneiform joint. Measurements were obtained for the preinjured, injured, and fixation conditions under static loading at 50% donor body weight. Specimens then underwent cyclic loading performed at 1 Hz and 100 cycles, based on 100-N stepwise increases in ground-reaction force from 100 to 2000 N, to simulate postoperative loading from the partial weightbearing stage to high-energy activities. Failure of fixation was defined as diastasis ≥2 mm at the Lisfranc articulation (second metatarsal-medial cuneiform joint). RESULTS: There were no significant differences in diastasis detected at the Lisfranc articulation or the intercuneiform joint throughout all loading cycles between groups. All specimens endured loading up to 50% body weight + 1400 N. Up to and including this stage, there were 2 failures in the cannulated transarticular crossed-screw group and none in the fiber tape group. CONCLUSION: The fiber tape construct with a supplemental intercuneiform limb, which does not require later removal, may provide comparable biomechanical stability to cannulated transarticular crossed screws, even at higher loads. CLINICAL RELEVANCE: Ligamentous Lisfranc injuries are common among athletes. Therefore, biomechanical evaluations are necessary to determine stable constructs that can limit the time to return to play. This study compares the biomechanical stability of 2 methods of fixation for ligamentous injury through a wide spectrum of loading, including those experienced by athletes.


Asunto(s)
Ligamentos Articulares , Huesos Metatarsianos , Fenómenos Biomecánicos , Peso Corporal , Tornillos Óseos , Cadáver , Humanos , Ligamentos Articulares/lesiones , Ligamentos Articulares/cirugía , Huesos Metatarsianos/lesiones , Huesos Metatarsianos/cirugía
20.
Inflamm Intest Dis ; 7(2): 81-86, 2022 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-35979189

RESUMEN

Background: Psychiatric disorders, including anxiety and depression, are significantly more common in patients with inflammatory bowel disease (IBD). We established an integrated psychiatry clinic for IBD patients at our tertiary center IBD clinic to provide patients with critical, but frequently unavailable, coordinated mental health services. We undertook this study to evaluate the impact of this service on psychiatric outcomes, quality of life, and symptom experience. Methods: We performed a longitudinal prospective study comparing patients who had been cared for at our integrated IBD-psychiatry clinic to those who had not. We abstracted demographic and clinical information as well as contemporaneous responses to validated surveys. Results: Thirty-six patients cared for in the IBD psychiatry clinic were compared to a control cohort of 35 IBD patients. There was a significant reduction in the Hospital Anxiety and Depression Scale (HADS) depression score over time in the study cohort (p = 0.001), though not in the HADS anxiety score. When compared to the control group, the study cohort showed a significant reduction in the HADS depression score. No significant differences were observed in the Harvey-Bradshaw Index, Simple Clinical Colitis Activity Index, or Short IBD Questionnaire. Conclusions: This is the first study to evaluate the impact of an integrated psychiatry clinic for IBD patients. Unlike their control counterparts, individuals treated in this clinic had a significant reduction in the mean HADS depression score. Larger scale studies are necessary to verify these findings. However, this study suggests that use of an integrated psychiatry IBD clinic model can result in improvement in mental health outcomes, even in the absence of significant changes in IBD activity.

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