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1.
Dis Colon Rectum ; 66(9): 1234-1244, 2023 09 01.
Artigo em Inglês | MEDLINE | ID: mdl-37000794

RESUMO

BACKGROUND: Despite their higher incidence of colorectal cancer, ethnoracial minority and low-income patients have reduced access to elective colorectal cancer surgery. Although the Affordable Care Act's Medicaid expansion increased screening of colonoscopies, its effect on disparities in elective colorectal cancer surgery remains unknown. OBJECTIVE: This study assessed the effects of Medicaid expansion on elective colorectal cancer surgery rates overall and by race-ethnicity and income. DESIGN: Using the 2012 to 2015 State Inpatient Databases, a retrospective cohort study was conducted. SETTINGS: State Inpatient Databases from 3 expansion states (Maryland, New Jersey, and Kentucky) and 2 nonexpansion states (Florida and North Carolina) were used. PATIENTS: This study examined 22,304 adult patients aged 18 to 64 years who underwent colorectal cancer surgery. MAIN OUTCOME MEASURES: Using interrupted time series analysis, the effect of Medicaid expansion on the odds of elective colorectal cancer surgery was assessed. RESULTS: Elective vs nonelective surgery rates remained unchanged overall (70.2% vs 70.7%, p = 0.63) and in ethnoracial minorities in expansion states (whites from 72.8% to 73.8% pre to post, p = 0.40 and non-white from 64.0% to 63.1% pre to post, p = 0.67). There was an instantaneous increase in odds of elective surgery in expansion vs nonexpansion states at policy implementation (adjusted OR 1.37; 95% CI, 1.05-1.79; p = 0.02), but it subsequently decreased (combined adjusted OR 0.95; 95% CI, 0.92-0.99; p = 0.03). Elective surgery rates were also unchanged among ethnoracial minorities (instantaneous changes in expansion states, combined effect 1.06; pre-trend 1.01 vs post-trend 0.98) and low-income persons in expansion states (pre-trend 1.03 vs post-trend 0.97) (for all, p > 0.1). LIMITATIONS: The study was limited to 5 states. Although patients may have increased access to cancer screening services and surgery after expansion, the State Inpatient Databases only provide information on patients who underwent surgery. CONCLUSIONS: Despite gains in screening, Medicaid expansion was not associated with reductions in known ethnoracial or income-based disparities in elective colorectal cancer surgery rates. Expanding access to colorectal cancer surgery for underserved populations likely requires attention to provider and health system factors contributing to persistent disparities. See Video Abstract at http://links.lww.com/DCR/C217 . DISPARIDADES PERSISTENTES EN EL ACCESO A LA CIRUGA ELECTIVA DEL CNCER COLORRECTAL DESPUS DE LA EXPANSIN DE MEDICAID EN VIRTUD DE LA LEY DEL CUIDADO DE SALUD A BAJO PRECIO UNA EVALUACIN MULTIESTATAL: ANTECEDENTES: A pesar de su mayor incidencia de cáncer colorrectal, los pacientes de minorías etnoraciales y de bajos ingresos tienen un acceso reducido a la cirugía electiva de cáncer colorrectal. Aunque la expansión de Medicaid de la Ley del Cuidado de Salud a Bajo Precio aumentó las colonoscopias de detección, aún se desconoce su efecto sobre las disparidades en la cirugía electiva de cáncer colorrectal.OBJETIVO: Este estudio evaluó los efectos de la expansión de Medicaid en las tasas de cirugía electiva de cáncer colorrectal en general y por raza, etnia e ingresos.DISEÑO: Utilizando las bases de datos estatales de pacientes hospitalizados de 2012-2015, se realizó un estudio de cohorte retrospectivo.CONFIGURACIÓN: Se utilizaron bases de datos estatales de pacientes hospitalizados de tres estados en expansión (Maryland, Nueva Jersey, Kentucky) y dos estados sin expansión (Florida, Carolina del Norte).PACIENTES: Este estudio examinó a 22,304 pacientes adultos de 18 a 64 años que se sometieron a cirugía de cáncer colorrectal.RESULTADO PRINCIPAL: Mediante el análisis de series de tiempo interrumpido, se evaluó el efecto de la expansión de Medicaid en las probabilidades de cirugía electiva de cáncer colorrectal.RESULTADOS: Las tasas de cirugía electiva frente a no electiva permanecieron sin cambios en general (70,2% frente a 70,7%, p = 0,63) y en las minorías etnoraciales en los estados de expansión (blancos del 72,8% al 73,8 % antes y después, p = 0,40 y no blancos del 64,0% al 63,1% pre a post, p = 0,67). Hubo un aumento instantáneo en las probabilidades de cirugía electiva en los estados de expansión frente a los de no expansión en la implementación de la política (OR ajustado 1,37, IC del 95%, 1,05-1,79, p = 0,02), pero disminuyó posteriormente (OR ajustado combinado 0,95, 95% IC, 0,92-0,99, p = 0,03). Las tasas de cirugía electiva también se mantuvieron sin cambios entre las minorías etnoraciales (cambios instantáneos en los estados de expansión, efecto combinado 1,06; antes de la tendencia 1,01 frente a la postendencia 0,98) y las personas de bajos ingresos en los estados de expansión (antes de la tendencia 1,03 frente a la postendencia 0,97; para todos, p > 0,1).LIMITACIONES: El estudio se limitó a cinco estados. Si bien los pacientes pueden tener un mayor acceso a los servicios de detección de cáncer y la expansión posterior a la cirugía, la base de datos de pacientes hospitalizados del estado solo brinda información sobre los pacientes que se sometieron a cirugía.CONCLUSIONES: A pesar de los avances en la detección, la expansión de Medicaid no se asoció con reducciones en las disparidades etnoraciales o basadas en los ingresos conocidas en las tasas de cirugía electiva de cáncer colorrectal. Ampliar el acceso a la cirugía del cáncer colorrectal para las poblaciones desatendidas probablemente requiera atención a los factores del proveedor y del sistema de salud que contribuyen a las disparidades persistentes. Consulte el Video Resumen en http://links.lww.com/DCR/C217 . (Traducción-Dr. Yesenia.Rojas-Khalil ).


Assuntos
Neoplasias Colorretais , Medicaid , Estados Unidos/epidemiologia , Adulto , Humanos , Patient Protection and Affordable Care Act , Estudos Retrospectivos , Colonoscopia , Neoplasias Colorretais/epidemiologia , Neoplasias Colorretais/cirurgia
2.
J Hip Preserv Surg ; 9(2): 84-89, 2022 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-35854808

RESUMO

The Femoro-Epiphyseal Acetabular Roof (FEAR) index is a newer measurement to identify the hip instability with borderline acetabular dysplasia. The purpose of this study is to (i) validate the FEAR index in determining the stability of the hip in patients who have previously been treated surgically for femoroacetabular impingement (FAI) and/or developmental dysplasia of the hip (DDH) and (ii) to examine the relationship between the FEAR index and femoral version, lateral center edge angle, Tönnis angle and alpha angle (AA). Patient demographics and radiographic measurements of 215 hips (178 patients), 116 hips treated with hip arthroscopy for FAI and 99 hips treated with periacetabular osteotomy (PAO) for DDH were compared between groups. The sensitivity and specificity of the FEAR index to detect the surgical procedure performed (PAO or hip arthroscopy) was calculated, and a threshold value was proposed. Pearson's correlation coefficients were used to describe the relationships between the FEAR index, femoral version and other radiographic measurements. The FEAR index was higher in patients with DDH versus FAI (DDH: 2.81 ± 0.50° versus FAI: -1.00 ± 0.21°, P < 0.001). A FEAR index threshold value of 3° had a sensitivity and specificity of 80% and 81%, respectively, for correctly predicting the surgical procedure performed. Femoral version was positively associated with the FEAR index in the setting of DDH (r = 0.36, P = 0.001) but not FAI (r = 0.02, P = 0.807). A FEAR index of 3° predicted treatment with 80% sensitivity and 81% specificity. In addition, femoral version significantly correlates with the FEAR index in the setting of DDH but not FAI.

3.
Geriatr Orthop Surg Rehabil ; 13: 21514593221091062, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-35450299

RESUMO

Background: Fragility hip fractures are a common orthopedic injury seen in Emergency Departments, with variable outcomes that can range from average to devastating. Currently, few reliable metrics to predict which patients will suffer post-operative complications exist. The aim of this study was to determine if the number and type of pre-operative medications can help predict post-operative complications. Methods: A prospectively collected database of hip fracture patients was retrospectively reviewed. Patients with isolated greater trochanteric fractures, periprosthetic fractures, or re-fractures were excluded. Pre-operative baseline characteristics as well as number and type of post-operative complications were reviewed. Any complication within 6 months of surgery and complications that could be directly attributable to the surgical procedure within 2 years of surgery were examined. Major complications (return to the operating room, deep infection, pulmonary, cardiac, and hematologic) and minor medical complications were assessed. A multivariate regression model was performed to identify independent risk factors. Results: Three-hundred ninety-one patients were included. A majority were aged 80-90 and female, and lived at home prior to presentation. Overall, 33.7% of patients suffered a complication within a 2-year follow-up period. Mortality rates were 5.4%, 10.0%, and 14.9% over 30 days, 1 year, and 2 years, respectively. After assessing this relationship while controlling for age, sex, injury type, pre-operative residence, ambulatory status, ASA score, and CCI score, the relationship remained significant for both an increased number of complications (P = .048) and a higher likelihood of having a complication (P = .008). Cardiovascular (P = .003), pulmonary (P = .001), gout (P = .002), or diabetes (P = .042) medications were associated with a higher likelihood for experiencing a complication. Conclusions: Our study suggests that there is a strong and linear relationship between the number and type of pre-operative medications taken and risk of post-operative complications. This exists for up to 8 medications, at which point further increase does not contribute to an increased risk of complication. This relationship exists even after controlling for confounding variables and can be used by surgeons to better counsel patients and families regarding their specific risk for suffering perioperative complications.

4.
Ann Thorac Surg ; 114(5): 1637-1644, 2022 11.
Artigo em Inglês | MEDLINE | ID: mdl-34678282

RESUMO

BACKGROUND: Cardiac surgery utilization has increased after passage of the Affordable Care Act. This multistate study examined whether changes in access after Medicaid expansion (ME) have led to improved outcomes, overall and particularly among ethnoracial minorities. METHODS: State Inpatient Databases were used to identify nonelderly adults (ages 18-64 years) who underwent coronary artery bypass grafting, aortic valve replacement, mitral valve replacement, or mitral valve repair in 3 expansion (Kentucky, New Jersey, Maryland) vs 2 nonexpansion states (North Carolina, Florida) from 2012 to 2015. Linear and logistic interrupted time series were used with 2-way interactions and adjusted for patient-level, hospital-level, and county-level factors to compare trends and instantaneous changes at the point of ME implementation (quarter 1 of 2014) for mortality, length of stay, and elective status. Interrupted time series models estimated expansion effect, overall and by race-ethnicity. RESULTS: Analysis included 22 038 cardiac surgery patients from expansion states and 33 190 from nonexpansion states. In expansion states, no significant trend changes were observed for mortality (odds ratio, 1.01; P = .83) or length of stay (ß = -0.05, P = .20), or for elective surgery (odds ratio, 1.00; P = .91). There were similar changes seen in nonexpansion states. Among ethnoracial minorities, ME did not impact outcomes or elective status. CONCLUSIONS: Despite an increase in cardiac surgery utilization after ME, outcomes remained unchanged in the early period after implementation, overall and among ethnoracial minorities. Future research is needed to confirm long-term trends and examine reasons behind this lack of improved outcomes.


Assuntos
Procedimentos Cirúrgicos Cardíacos , Medicaid , Adulto , Estados Unidos , Humanos , Adolescente , Adulto Jovem , Pessoa de Meia-Idade , Patient Protection and Affordable Care Act , Grupos Minoritários , Etnicidade , Cobertura do Seguro
5.
Hip Int ; 32(5): 641-647, 2022 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-33678039

RESUMO

BACKGROUND: Despite improving diagnostic and surgical techniques, some patients do not respond as well as others following hip arthroscopy. In most musculoskeletal studies, predictors for surgical outcomes focus solely on physical health prior to surgery. However, there likely exists a relationship between a patient's mental health and their postoperative patient-reported outcome measures (PROMs). METHODS: 40 patients who met indications for hip arthroscopy were enrolled in this prospective cohort study. All patients completed a baseline Brief Resilience Scale (BRS) and 4validated PROMs: modified Harris Hip Score (mHHS), visual analogue scale for pain (VAS), Hip Outcomes Score for Activities of Daily Living (HOS-Daily), and Hip Outcomes Score for Sports-Related Activities (HOS-Sport). For a secondary measure of psychometric evaluation, past medical histories of anxiety/depression were recorded. Patients were stratified into Low Resilience (LR < 21), Normal Resilience (NR 22-24), and High Resilience (HR > 25) by tertile to determine differences in PROMs. Comparisons and correlations of pre- and postoperative outcomes between resilience groups were performed. RESULTS: In comparing the LR and HR groups, there was a significant relationship between resilience and all PROMs both preoperatively and 6 months postoperatively (p < 0.05), with the exception of the HOS-Sports. Pearson Correlation Coefficients confirmed this trend in the mHHS and the HOS-Daily. Additionally, there were sixteen patients who were discharged prior to 6-month follow-up with an average resilience above the mean of total population (p < 0.0001). Resilience was associated with return to activity (p = 0.017). A past history of anxiety/depression was associated with lower resilience (p = 0.039). CONCLUSIONS: This study showed that HR hip arthroscopy patients had better PROMs than LR patients both preoperatively and postoperatively. HR patients were able to return to activity earlier and had lower rates of preoperative anxiety/depression. The BRS is a simple in-office screening tool, which may help guide patient and doctor communication and expectations.


Assuntos
Artroplastia de Quadril , Impacto Femoroacetabular , Atividades Cotidianas , Artroscopia/métodos , Impacto Femoroacetabular/cirurgia , Seguimentos , Articulação do Quadril/cirurgia , Humanos , Medidas de Resultados Relatados pelo Paciente , Estudos Prospectivos , Resultado do Tratamento
6.
Ann Thorac Surg ; 112(3): 786-793, 2021 09.
Artigo em Inglês | MEDLINE | ID: mdl-33188751

RESUMO

BACKGROUND: Medicaid expansion (ME) under the Affordable Care Act has reduced the number of uninsured patients, although its preferential effects on vulnerable populations have been mixed. This study examined whether ME preferentially improved cardiac surgery use by insurance strata, race, and income level. METHODS: Non-elderly adults (aged 18-64 years) who underwent coronary artery bypass grafting, aortic valve replacement, mitral valve replacement, or mitral valve repair were identified in the State Inpatient Databases for 3 expansion states (Kentucky, New Jersey, and Maryland) and 2 non-expansion states (North Carolina and Florida) from 2012 to the third quarter of 2015. We used adjusted Poisson interrupted time series to determine the impact of ME on cardiac surgery use for Medicaid or uninsured (MCD/UIS) patients, racial and ethnic minorities, and individuals from low-income areas. RESULTS: In expansion states, use among non-White MCD/UIS patients had a positive trend after ME (2.3%/quarter; P = .156), whereas use for White MCD/UIS patients fell (-1.7%/quarter; P = .117). In contrast, use among non-White MCD/UIS in non-expansion states decreased by 4.4% (P < .001) which was a greater decline than among White MCD/UIS patients (-1.8%/quarter; P = .057). There was no substantial effect of ME on cardiac surgery use for MCD/UIS patients from low- versus high-income areas. CONCLUSIONS: These findings demonstrate that the use of cardiac surgical procedures was generally unchanged after ME; however, nonsignificant trend differences suggest a narrowing gap between vulnerable and non-vulnerable groups in ME states. These preliminary findings help describe the association of insurance coverage as a driver of cardiac surgery use among vulnerable patients.


Assuntos
Procedimentos Cirúrgicos Cardíacos/estatística & dados numéricos , Medicare/organização & administração , Patient Protection and Affordable Care Act , Utilização de Procedimentos e Técnicas/estatística & dados numéricos , Populações Vulneráveis , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Estados Unidos
7.
J Thorac Dis ; 12(10): 6173-6178, 2020 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-33209455

RESUMO

Robotic technology is positioned to transform the approach to tracheobronchial surgery. With its magnified 3D view, intuitive controls, wristed-instruments, high-fidelity simulation platforms, and the steady implementation of new technical improvement, the robot is well-suited to manage the careful dissection and delicate handling of the airway in tracheobronchial surgery. This innovative technology has the potential to promote the widespread adoption of minimally invasive techniques for this complex thoracic surgery.

9.
J Shoulder Elbow Surg ; 29(11): 2200-2212, 2020 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-32707325

RESUMO

BACKGROUND: Total shoulder arthroplasty is an accepted treatment for glenohumeral osteoarthritis. The Arthrex Eclipse shoulder prosthesis is a stemless, canal-sparing humeral prosthesis with bone ingrowth capacity on the trunnion, as well as through the fenestrated hollow screw, that provides both diaphyseal and metaphyseal load sharing and fixation. METHODS: Between 2013 and 2018, 16 sites in the United States enrolled 327 patients (Eclipse in 237 and Arthrex Univers II in 90). All patients had glenohumeral arthritis refractory to nonsurgical care. Strict exclusion criteria were applied to avoid confounding factors such as severe patient comorbidities, arthritis not consistent with osteoarthritis, and medical or prior surgical treatments that may have affected outcomes. Patients were randomized to the Eclipse or Univers II group via block randomization. RESULTS: In total, 149 Eclipse and 76 Univers II patients reached 2-year follow-up (139 Eclipse patients [93.3%] and 68 Univers II patients [89.5%] had complete data). The success rate using the Composite Clinical Success score was 95% in the Eclipse group vs. 89.7% in the Univers II group. No patient exhibited radiographic evidence of substantial humeral radiolucency, humeral migration, or subsidence at any point. Reoperations were performed in 7 patients (3.2%) in the Eclipse group and 3 (3.8%) in the Univers II group. CONCLUSION: The Arthrex Eclipse shoulder prosthesis is a safe and effective humeral implant for patients with glenohumeral arthritis at 2-year follow-up, with no differences in outcomes compared with the Univers II shoulder prosthesis.


Assuntos
Parafusos Ósseos , Osteoartrite/cirurgia , Articulação do Ombro/cirurgia , Prótese de Ombro , Adulto , Idoso , Idoso de 80 Anos ou mais , Artroplastia do Ombro , Desenho de Equipamento , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Complicações Pós-Operatórias , Estudos Prospectivos , Resultado do Tratamento , Estados Unidos , Adulto Jovem
10.
Eur J Orthop Surg Traumatol ; 30(5): 909-916, 2020 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-32162048

RESUMO

INTRODUCTION: Reverse shoulder arthroplasty (RSA) is a common treatment for proximal humeral fractures (PHFs) in the elderly. This study evaluates the influence of tuberosity healing (TH) on functional outcome following a 135° humeral inclination RSA for PHFs. METHODS: Retrospectively, all patients with an acute PHF treated with a 135° humeral inclination RSA at four centers during a three-year period were followed up. Constant score (CS), TH and glenoid notching were analyzed. RESULTS: Sixty-four of 100 patients (64%) with a mean age of 76 ± 7 years were available for follow-up at 22 ± 8 months. The mean-adjusted CS was 72%. TH of the greater tuberosity (GT) was 77% and resulted in significantly improved forward flexion (128° vs. 92°; p = 0.003), external rotation (33° vs. 17°; p = 0.03) and adjusted CS (78% vs. 54%, p < 0.005). GT healing rate was 86% with neutral, 70% with lateralized and 33% with an inferior eccentric glenosphere. TH of the lesser tuberosity was 79%. There was 8% complication and 3% revision rate; implant survival was 100%. CONCLUSION: RSA with 135° humeral inclination for PHFs leads to good functional outcome, reproducible results and a high rate of TH. The short-term revision rate is low. TH is associated with improved ROM and functional outcome. LEVEL OF EVIDENCE: III.


Assuntos
Artroplastia do Ombro/métodos , Úmero/fisiopatologia , Fraturas do Ombro/cirurgia , Articulação do Ombro/fisiopatologia , Idoso , Idoso de 80 Anos ou mais , Artroplastia do Ombro/efeitos adversos , Feminino , Seguimentos , Consolidação da Fratura , Humanos , Úmero/lesões , Masculino , Complicações Pós-Operatórias/etiologia , Amplitude de Movimento Articular , Reoperação , Estudos Retrospectivos , Articulação do Ombro/cirurgia , Prótese de Ombro
11.
J Thorac Dis ; 10(8): 4686-4688, 2018 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-30233839
12.
Orthopedics ; 41(1): 21-27, 2018 Jan 01.
Artigo em Inglês | MEDLINE | ID: mdl-28877326

RESUMO

Historically, upper extremity deep venous thromboses (DVTs) have been rare; however, their incidence has increased as awareness has increased. Patients who develop upper extremity DVTs often have multiple comorbidities. However, in the past decade, studies have found a small risk of upper extremity DVTs associated with orthopedic procedures involving the upper extremity. The risk of complications following a DVT, including postthrombotic syndrome and pulmonary embolism, is substantially higher with a DVT of the upper extremity compared with a DVT of the lower extremity. Furthermore, there is no consensus regarding the role and efficacy of prophylactic measures in preventing upper extremity DVT after upper extremity surgery. This article discusses the use of prophylactic agents after elective upper extremity surgery, with an emphasis on the efficacy of commonly used interventions. [Orthopedics. 2018; 41(1):21-27.].


Assuntos
Procedimentos Cirúrgicos Eletivos/efeitos adversos , Embolia Pulmonar/etiologia , Trombose Venosa Profunda de Membros Superiores/etiologia , Trombose Venosa/etiologia , Idoso , Aspirina/uso terapêutico , Cardiologia/normas , Comorbidade , Bandagens Compressivas , Humanos , Incidência , Extremidade Inferior , Pessoa de Meia-Idade , Ortopedia , Embolia Pulmonar/epidemiologia , Fatores de Risco , Extremidade Superior , Trombose Venosa Profunda de Membros Superiores/epidemiologia , Trombose Venosa/epidemiologia
13.
BMC Musculoskelet Disord ; 18(1): 374, 2017 Aug 30.
Artigo em Inglês | MEDLINE | ID: mdl-28854973

RESUMO

BACKGROUND: To determine the safety and efficacy of collagenase clostridium histolyticum (CCH) injection for the treatment of palmar Dupuytren disease nodules. METHODS: In this 8-week, double-blind trial, palpable palmar nodules on one hand of adults with Dupuytren disease were selected for treatment. Patients were randomly assigned using an interactive web response system to receive a dose of 0.25 mg, 0.40 mg, or 0.60 mg (1:1:1 ratio) and then allocated to active treatment (CCH) or placebo (4:1 ratio). All patients and investigators were blinded to treatment. One injection was made in the selected nodule on Day 1. Caliper measurements of nodule length and width were performed at screening and at Weeks 4 and 8. Investigator-reported nodular consistency and hardness were evaluated at baseline and Weeks 1, 4, and 8. Investigator-rated patient improvement (1 [very much improved] to 7 [very much worse]) and patient satisfaction were assessed at study end. RESULTS: In the efficacy population (n = 74), percentage changes in area were significantly greater with CCH 0.40 mg (-80.1%, P = 0.0002) and CCH 0.60 mg (-78.2%, P = 0.0003), but not CCH 0.25 mg (-58.3%, P = 0.079), versus placebo (-42.2%) at post-treatment Week 8. Mean change in nodular consistency and hardness were significantly improved with CCH versus placebo at Weeks 4 and 8 (P ≤ 0.0139 for all). At Week 8, investigator global assessment of improvement was significantly greater with CCH 0.40 mg and 0.60 mg (P ≤ 0.0014) but not statistically significant with CCH 0.25 mg versus placebo (P = 0.13). Most patients were "very satisfied" or "quite satisfied" with CCH 0.40 mg and 0.60 mg. Contusion/bruising (50.0% to 59.1%) was the most common adverse event with CCH treatment. CONCLUSION: In patients with Dupuytren disease, a single CCH injection significantly improved palmar nodule size and hardness. The safety of CCH was similar to that observed previously in patients with Dupuytren contracture. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02193828 . Date of trial registration: July 2, 2014 to December 5, 2014.


Assuntos
Clostridium histolyticum , Contratura de Dupuytren/diagnóstico , Contratura de Dupuytren/tratamento farmacológico , Colagenase Microbiana/administração & dosagem , Idoso , Contusões/induzido quimicamente , Método Duplo-Cego , Feminino , Humanos , Injeções Intralesionais , Masculino , Colagenase Microbiana/efeitos adversos , Pessoa de Meia-Idade , Resultado do Tratamento
14.
J Sex Med ; 14(7): 883-890, 2017 07.
Artigo em Inglês | MEDLINE | ID: mdl-28673432

RESUMO

BACKGROUND: Implantation of testosterone doses of at least 150 to 450 mg (ie, two to six pellets) is common clinical practice despite a lack of prospective data. AIM: To evaluate pharmacokinetics, clinical efficacy, safety, and patient-reported outcomes in men with androgen deficiency who received implantation of testosterone pellets (900 mg) in an open-label study. METHODS: Men with androgen deficiency (serum testosterone < 300 ng/dL [10.4 nmol/L]) were screened and received 12 testosterone pellets (900 mg). Serum hormone measurements (total and free testosterone, dihydrotestosterone, and estradiol) were obtained on days 1, 5, 8, 15, 29, 57, 85, and 113. All hormones were assayed using validated liquid chromatography and tandem mass spectrometry. OUTCOMES: Pharmacokinetics of selected hormones was determined. The patient-reported International Index of Erectile Function (IIEF), Center for Epidemiologic Studies Depression (CES-D), and Androgen Deficiency in the Aging Male (qADAM) questionnaires also were performed. Patients rated their satisfaction on a scale from 1 (very satisfied) to 5 (very dissatisfied). Adverse events were monitored throughout. RESULTS: Fifteen patients were included (mean age = 54.5 years, SD = 8.6 years). Mean baseline total testosterone concentration was 241.6 ng/dL (SD = 88.8 ng/dL; mean = 8.4 nmol/L, SD = 3.1 nmol/L). Mean testosterone serum concentrations fluctuated during the first 2 weeks (range = 300-1,000 ng/dL, 10.4-34.7 nmol/L) but remained higher than or equal to 300 ng/dL (10.4 nmol/L) through day 113. Concentrations of free testosterone, dihydrotestosterone, and estradiol mirrored that of total testosterone. Male functioning (IIEF score), depression (CES-D total score), and androgen-deficiency symptoms (qADAM total score) improved from baseline. Most patients were "very satisfied" (40.0%) or "quite satisfied" (26.7%) with treatment. Testosterone pellets were well tolerated. Pellet extrusion and polycythemia occurred in one patient each. CLINICAL IMPLICATIONS: Implantation of high doses (900 mg) of testosterone pellets are generally well tolerated and could provide clinical benefit for some patients. STRENGTHS AND LIMITATIONS: This study provides standardized data for the implantation of 12 testosterone pellets. However, the open-label uncontrolled design of this study and its small and ethnically non-diverse patient population limit the interpretation of these data, particularly the patient-reported outcomes. CONCLUSION: Implantation of 12 testosterone pellets (900 mg) was well tolerated and provided adequate and sustained serum testosterone concentrations. Additional randomized controlled trials are needed to confirm efficacy and safety findings. McMahon CG, Shusterman N, Cohen B. Pharmacokinetics, Clinical Efficacy, Safety Profile, and Patient-Reported Outcomes in Patients Receiving Subcutaneous Testosterone Pellets 900 mg for Treatment of Symptoms Associated With Androgen Deficiency. J Sex Med 2017;14:883-890.


Assuntos
Hipogonadismo/tratamento farmacológico , Testosterona/farmacocinética , Adolescente , Adulto , Idoso , Di-Hidrotestosterona , Implantes de Medicamento/administração & dosagem , Implantes de Medicamento/efeitos adversos , Implantes de Medicamento/farmacocinética , Estradiol/sangue , Humanos , Hipogonadismo/sangue , Hipogonadismo/fisiopatologia , Hipogonadismo/psicologia , Masculino , Pessoa de Meia-Idade , Medidas de Resultados Relatados pelo Paciente , Satisfação do Paciente , Ereção Peniana , Estudos Prospectivos , Inquéritos e Questionários , Testosterona/administração & dosagem , Testosterona/efeitos adversos , Testosterona/sangue , Resultado do Tratamento , Adulto Jovem
15.
Orthopedics ; 40(5): 282-286, 2017 Sep 01.
Artigo em Inglês | MEDLINE | ID: mdl-28530768

RESUMO

Rheumatoid arthritis (RA) is a chronic, systemic autoimmune disorder known to cause progressive joint destruction. Over time, untreated RA can lead to pain and increasing disability, making orthopedic intervention necessary. The treatment of RA revolves around a variety of medications that blunt the overall immune response. However, this may increase the risk of infection and impair wound healing. Given the nature of this disease, orthopedists frequently encounter patients with RA in the operative setting. To optimize surgical outcomes, orthopedists must carefully manage and pay special attention to the adverse side effects of the complicated medication regimens of these patients perioperatively. [Orthopedics. 2017; 40(5):282-286.].


Assuntos
Artrite Reumatoide/cirurgia , Antirreumáticos/efeitos adversos , Antirreumáticos/uso terapêutico , Artrite Reumatoide/tratamento farmacológico , Humanos , Infecções/etiologia , Masculino , Pessoa de Meia-Idade , Procedimentos Ortopédicos/efeitos adversos , Complicações Pós-Operatórias , Fatores de Risco , Cicatrização
16.
J Hand Surg Am ; 41(12): 1171-1175, 2016 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-27751780

RESUMO

Double crush syndrome (DCS), as it is classically defined, is a clinical condition composed of neurological dysfunction due to compressive pathology at multiple sites along a single peripheral nerve. The traditional definition of DCS is narrow in scope because many systemic pathologic processes, such as diabetes mellitus, drug-induced neuropathy, vascular disease and autoimmune neuronal damage, can have deleterious effects on nerve function. Multifocal neuropathy is a more appropriate term describing the multiple etiologies (including compressive lesions) that may synergistically contribute to nerve dysfunction and clinical symptoms. This paper examines the history of DCS and multifocal neuropathy, including the epidemiology and pathophysiology in addition to principles of evaluation and management.


Assuntos
Síndrome de Esmagamento/complicações , Síndromes de Compressão Nervosa/diagnóstico , Doenças do Sistema Nervoso Periférico/cirurgia , Procedimentos de Cirurgia Plástica/métodos , Recuperação de Função Fisiológica , Terminologia como Assunto , Síndrome do Túnel Carpal/etiologia , Síndrome do Túnel Carpal/fisiopatologia , Síndrome do Túnel Carpal/cirurgia , Lesões por Esmagamento/complicações , Lesões por Esmagamento/diagnóstico , Lesões por Esmagamento/cirurgia , Síndrome de Esmagamento/diagnóstico , Síndrome de Esmagamento/cirurgia , Gerenciamento Clínico , Feminino , Traumatismos da Mão/complicações , Traumatismos da Mão/diagnóstico , Traumatismos da Mão/cirurgia , Humanos , Escala de Gravidade do Ferimento , Masculino , Síndromes de Compressão Nervosa/etiologia , Síndromes de Compressão Nervosa/cirurgia , Doenças do Sistema Nervoso Periférico/etiologia , Doenças do Sistema Nervoso Periférico/fisiopatologia , Medição de Risco , Resultado do Tratamento , Cicatrização/fisiologia
17.
J Gastrointest Surg ; 20(9): 1636-42, 2016 09.
Artigo em Inglês | MEDLINE | ID: mdl-27405310

RESUMO

BACKGROUND: Anti-tumor necrosis factor (TNF) agents have been an integral part in the treatment of inflammatory bowel disease. However, a subset of inflammatory bowel disease patients ultimately requires surgery and up to 30 % of them have undergone treatment with anti-TNF agents. Studies assessing the effect of anti-TNF agents on postoperative outcomes have been inconsistent. The aim of this study is to assess postoperative morbidity in inflammatory bowel disease patients who underwent surgery with anti-TNF therapy prior to surgery. METHODS: This is a retrospective review of 282 patients with inflammatory bowel disease undergoing intestinal surgery between 2013 and 2015 at the Mount Sinai Hospital. Patients were divided into two groups based on treatment with anti-TNF agents (infliximab, adalimumab, certolizumab) within 8 weeks of surgery. Thirty-day postoperative outcomes were recorded. Univariate and multivariate statistical analyses were carried out. RESULTS: Seventy-three patients were treated with anti-TNF therapy within 8 weeks of surgery while 209 patients did not have exposure. Thirty-day anastomotic leak, intra-abdominal abscess, wound infection, extra-abdominal infection, readmission, and mortality rates were not significantly different between the two groups. CONCLUSIONS: The use of anti-TNF medications in inflammatory bowel disease patients within 2 months of intestinal surgery is not associated with an increased risk of 30-day postoperative complications.


Assuntos
Abscesso Abdominal/epidemiologia , Fístula Anastomótica/epidemiologia , Fármacos Gastrointestinais/uso terapêutico , Doenças Inflamatórias Intestinais/tratamento farmacológico , Infecção da Ferida Cirúrgica/epidemiologia , Fator de Necrose Tumoral alfa/antagonistas & inibidores , Adalimumab/uso terapêutico , Adulto , Certolizumab Pegol/uso terapêutico , Feminino , Humanos , Doenças Inflamatórias Intestinais/cirurgia , Infliximab/uso terapêutico , Masculino , Pessoa de Meia-Idade , Readmissão do Paciente/estatística & dados numéricos , Período Pós-Operatório , Estudos Retrospectivos , Taxa de Sobrevida , Resultado do Tratamento , Adulto Jovem
18.
J Hand Surg Am ; 40(10): 1963-71, 2015 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-26216077

RESUMO

PURPOSE: To evaluate efficacy and safety of concurrent administration of 2 collagenase clostridium histolyticum (CCH) injections to treat 2 joints in the same hand with Dupuytren fixed flexion contractures (FFCs). METHODS: Patients with 2 or more contractures in the same hand caused by palpable cords participated in a 60-day, multicenter, open-label, phase 3b study. Two 0.58 mg CCH doses were injected into 1 or 2 cords in the same hand (1 injection per affected joint) during the same visit. Finger extension was performed approximately 24, 48, or 72 or more hours later. Changes in FFC and range of motion, incidence of clinical success (FFC ≤ 5°), and adverse events (AEs) were summarized. RESULTS: The study enrolled 715 patients (725 treated joint pairs), and 714 patients (724 joint pairs) were analyzed for efficacy. At day 31, mean total FFC (sum of 2 treated joints) decreased 74%, from 98° to 27°. Mean total range of motion increased from 90° to 156°. The incidence of clinical success was 65% in metacarpophalangeal joints and 29% in proximal interphalangeal joints. Most treatment-related AEs were mild to moderate, resolving without intervention; the most common were swelling of treated extremity, contusion, and pain in extremity. The incidence of skin lacerations was 22% (160 of 715). Efficacy and safety were similar regardless of time to finger extension. CONCLUSIONS: Collagenase clostridium histolyticum can be used to effectively treat 2 affected joints concurrently without a greater risk of AEs than treatment of a single joint, with the exception of skin laceration. The incidence of clinical success in this study after 1 injection per joint was comparable to phase 3 study results after 3 or more injections per joint. Two concurrent CCH injections may allow more rapid overall treatment of multiple affected joints, and the ability to vary the time between CCH injection and finger extension may allow physicians and patients greater flexibility with scheduling treatment.


Assuntos
Clostridium histolyticum/enzimologia , Contratura de Dupuytren/tratamento farmacológico , Colagenase Microbiana/administração & dosagem , Amplitude de Movimento Articular/efeitos dos fármacos , Idoso , Relação Dose-Resposta a Droga , Esquema de Medicação , Contratura de Dupuytren/diagnóstico por imagem , Feminino , Seguimentos , Força da Mão/fisiologia , Humanos , Injeções Intralesionais , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Radiografia , Recuperação de Função Fisiológica , Retratamento , Medição de Risco , Índice de Gravidade de Doença , Resultado do Tratamento
19.
J Pediatr Surg ; 50(6): 923-7, 2015 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-25841283

RESUMO

PURPOSE: The purpose of this retrospective study was to investigate outcomes in children who underwent a non-diagnostic ultrasound (US) evaluating for appendicitis and to identify predictors of a negative diagnosis. METHODS: An IRB-approved retrospective chart review was performed on patients age 0-18, who underwent an abdominal US evaluating for acute appendicitis from 2004 through 2013. Clinical data and specified outcomes were recorded, and exams were categorized into non-diagnostic studies and further separated into studies where the appendix was non-visualized. RESULTS: Of the 1383 studies included for analysis, 876 were non-diagnostic for acute appendicitis (63.34%) with 777 specifically because the appendix was non-visualized. Seven hundred forty of the 876 non-diagnostic studies and 671 of the 777 non-visualized studies were ultimately considered true negatives, corresponding to a negative predictive value (NPV) of 84.47 and 86.36%, respectively. In patients with WBC <7.5×10(9)/L, the NPV of non-diagnostic and non-visualized studies increased to 97.12 and 98.86%, respectively. Patients with WBC <11.0×10(9)/L have similarly high NPVs of 95.59 and 96.99% (non-diagnostic and non-visualized). CONCLUSION: Based on the high NPV of a non-diagnostic US in children without leukocytosis, these patients may safely avoid further diagnostic imaging for the workup of suspected appendicitis.


Assuntos
Apendicite/diagnóstico por imagem , Apêndice/diagnóstico por imagem , Doença Aguda , Adolescente , Criança , Pré-Escolar , Reações Falso-Negativas , Feminino , Humanos , Lactente , Recém-Nascido , Masculino , Valor Preditivo dos Testes , Estudos Retrospectivos , Ultrassonografia
20.
J Hand Surg Am ; 40(5): 975-83, 2015 May.
Artigo em Inglês | MEDLINE | ID: mdl-25843533

RESUMO

PURPOSE: To examine the results of proximal interphalangeal (PIP) joint contractures from 4 phase 3 clinical trials of collagenase clostridium histolyticum (CCH) injection for Dupuytren contracture. METHODS: Patients enrolled in Collagenase Option for Reduction of Dupuytren I/II and JOINT I/II with one or more PIP joint contractures (20° to 80°) received CCH 0.58 mg/0.20 mL or placebo (Collagenase Option for Reduction of Dupuytren I/II only) injected directly into a palpable cord. The percentage of PIP joints achieving clinical success (0° to 5° of full extension), clinical improvement (50% or more reduction in baseline contracture), and range of motion improvement at 30 days after the first and last CCH injections was assessed. The PIP joint contractures were classified into low (40° or less) and high (more than 40°) baseline severity. Adverse events were recorded. RESULTS: A total of 506 adults (mean age, 63 ± 10 y; 80% male) received 1,165 CCH injections in 644 PIP joint cords (mean, 1.6 injections/cord). Most patients (60%) received 1 injection, with 24%, 16%, and 1% receiving 2, 3, and 4 injections, respectively. Clinical success and clinical improvement occurred in 27% and 49% of PIP joints after one injection and in 34% and 58% after the last injection. Patients with lower baseline severity showed greater improvement and response was comparable between fingers, as were improvements in range of motion. Adverse events occurring in more than 10% of patients were peripheral edema (58%), contusion (38%), injection site hemorrhage (23%), injection site pain (21%), injection site swelling (16%), and tenderness (13%). This incidence was consistent with data reported in phase 3 trials. Two tendon ruptures occurred. No further ruptures occurred after a modified injection technique was adopted. CONCLUSIONS: Collagenase clostridium histolyticum was effective and well tolerated in the short term in patients with Dupuytren PIP joint contractures. TYPE OF STUDY/LEVEL OF EVIDENCE: Therapeutic II.


Assuntos
Clostridium histolyticum/enzimologia , Contratura de Dupuytren/tratamento farmacológico , Falanges dos Dedos da Mão , Colagenase Microbiana/uso terapêutico , Feminino , Humanos , Injeções , Masculino , Colagenase Microbiana/administração & dosagem , Pessoa de Meia-Idade , Recidiva , Índice de Gravidade de Doença , Resultado do Tratamento
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