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Background: Switching between therapies is a recommended strategy for psoriatic arthritis (PsA) patients who experience treatment failure; however, studies including real-life data are scarce. Objectives: To assess the incidence rate (IR) of switching between biologics and targeted synthetic disease-modifying anti-rheumatic drugs (b/tsDMARDs) due to inefficacy in PsA, and to compare the risk of switching due to inefficacy across different b/tsDMARDs groups. Design: A longitudinal retrospective study, spanning from 2007 to 2022, was conducted on patients with PsA treated with b/tsDMARDs at an outpatient rheumatology clinic. Methods: The primary outcome was switching between b/tsDMARDs due to inefficacy. The independent variable was the exposure to b/tsDMARDs during follow-up. As covariates, clinical, treatment-related, and sociodemographic variables were considered. Survival techniques were run to estimate the IR of switching due to inefficacy per 100 patients*year and confidence interval at 95% (95% CI). Cox multivariate regression analyses were run to assess the risk of b/tsDMARDs switching due to inefficacy, expressed as hazard ratio (HR) and 95% CI. Results: In all, 141 patients were included, with 893.09 patients*year follow-ups. 52.48% of them were females in their fifties. In total, 262 courses of treatment were recorded. During the study period, 56 patients presented 121 switches and 103 related to inefficacy (IR: 11.53 (9.51-13.98)). Tumor necrosis factor-alpha inhibitors (TNFi) showed the lowest IR. In the bivariate analysis, all b/tsDMARDs had more risk of switching compared to TNFi (HR: anti-lL-17 vs TNFi: 2.26 (1.17-4.36); others vs TNFi: 3.21 (1.59-6.45)); however, this statistical significance was no longer present in the multivariate analysis once adjustments were made for the covariates. Still, the final model achieved statistical significance in the following variables: gender, clinical symptoms, prescription year, therapy courses, glucocorticoids, and sulfasalazine. Conclusion: In this study, we did not find differences in the rate of switching due to inefficacy among different groups of b/tsDMARDs. Other concomitant treatments, sociodemographic, and clinical variables were identified as risk factors for switching due to inefficacy.
METHODS: We included patients from 2007 to 2022 in which their consultant rheumatologist had decided to commence them on biologic therapy. We studied the changes due to drug failure, we also included sociodemographic, clinical and treatments information. RESULTS: The study comprised 141 patients. 52% were women in their fifties. We found that 56 patients change drugs 121 times, with 103 of those changes due to failure drug. This means about 11 out of every 100 patients change their biologic therapy each year. There was no difference in the risk of change between the different studied biologic therapies. Women, those with inflammatory back pain, and those who had tried many different drugs were more likely to change due to drug failure. Using additional therapies like glucocorticoids and sulfasalazine also increased the probability of biologic therapy change. CONCLUSION: Our work did not find differences in the risk of change due to drug failure among different biologic therapies.
Changes due to drug failure between biologic therapies: a real-life study in psoriatic arthritis patients Introduction: We wanted to evaluate how often patients with psoriatic arthritis change between different drugs because the drugs weren't working well enough. Additionally, we evaluated which factors could influence the change due to drug failure. The studied drugs are biological therapies that are arthritis-modifying drugs designed early in the last decade to prevent or reduce inflammation caused by the disease.
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STUDY DESIGN: Retrospective cohort study. OBJECTIVE: To assess relative odds of perioperative complications, readmissions, and five-year survival to reoperation for three-level lumbar decompression patients who undergo three-level fusion relative to one-level fusion. BACKGROUND: Patients undergoing multilevel lumbar decompression may be indicated for fusion at one or more levels. The question of fusing only one level with indications such as spondylolisthesis or fusing all levels decompressed is of clinical interest in both the short and longer term. METHODS: Patients undergoing three-level lumbar decompression were extracted from the PearlDiver M165Orto database. The subset of these patients undergoing concomitant three-level and one-level lumbar fusion were identified and matched 1:1 based on patient age, sex, and Elixhauser Comorbidity Index (ECI) scores. The incidence and odds of 90-day postoperative adverse events were compared between the two groups by multivariable analysis, and comparative five-year survival to lumbar spinal reoperation was determined. RESULTS: After matching, 28,276 patients were identified as undergoing three-level lumbar decompression with three-level fusion and the same for those undergoing three-level decompression with one-level fusion. Controlling for patient age, sex, and ECI, three-level fusion patients had significantly greater odds ratio (OR) of many 90-day adverse events and aggregated any (OR 1.42), serious (OR 1.44), and minor (OR 1.42) adverse events, as well as readmissions (OR 1.51) (P<0.0001 for all). Five-year survival to reoperation was significantly lower for those undergoing three-level decompression with three-level fusion (P<0.0001). CONCLUSIONS: Three-level lumbar decompression patients who underwent three-level fusion were found to be at significantly greater odds of 90-day postoperative adverse events, readmissions, and five-year reoperations relative to those undergoing one-level fusion. The current data support the concept of limiting fusion to the levels with specific indications in the setting of multi-level lumbar decompressions and not needing to match the decompression and fusion levels.
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STUDY DESIGN: Retrospective cohort analysis. OBJECTIVE: CCS is the most common type of incomplete spinal cord injury and can occur without or with bony injury. Surgical intervention and its timing for patients diagnosed with CCS has been controversial. The current study assessed utilization of and factors associated with operative intervention and its timing in patients diagnosed with central cord syndrome (CCS) in the absence of bony injury. METHODS: Adult patients diagnosed with CCS in the absence of vertebral fracture were queried from the national, multi-insurance, administrative 2015-2020 M151 PearlDiver database. The incidence, trends, and timing of operative intervention following CCS were assessed. Patient characteristics associated with surgical intervention and its timing were determined. RESULTS: From 2015 to 2020, 11,653 patients meeting inclusion criteria were identified, of which surgical intervention was identified for 2,003 (17.2%) and thus nonsurgical intervention for 9,650 (82.8%). The proportion of patients undergoing operative intervention evolved from 11.5% in 2015 to 19.7% in 2020 (p < 0.0001). Of those undergoing surgical intervention, the greatest increase was seen for those undergoing surgery within two days of diagnosis (5.5% in 2015 to 12.3% in 2020, p < 0.0001). On multivariable analysis, more recent year of service, region of service, younger age, and higher comorbidity burden were independent predictors of operative management (p < 0.05 for all). CONCLUSION: The majority of a large cohort of patients with first diagnosis CCS in the absence of bony injury were managed non-operatively. Operative management increased over the years of study, were performed earlier after diagnosis, and varied based on patient characteristic and geographic region.
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Introduction: The aim of the present study was to determine the effectiveness of simultaneous bilateral visual diaphragm biofeedback (BFB) from ultrasonography in conjunction with inspiratory muscle training (IMT) on diaphragmatic thickness during normal breathing and respiratory and clinical outcomes in patients with non-specific low back pain (NSLBP) and determine the influence of age and sex. Methods: A single-blind randomized clinical trial was carried out (NCT04582812). A total sample of 96 patients with NSLBP was recruited and randomized by sex-based stratification into IMT (n = 48) and BFB + IMT (n = 48) interventions over 8 weeks. Bilateral diaphragmatic thickness at maximum inspiration (Tins) and expiration (Texp), respiratory pressures, lung function, pain intensity, bilateral pressure pain threshold (PPT), disability, and quality of life were measured at baseline and after 8 weeks. Results: The BFB + IMT group showed significant differences (p < 0.05) with increased left hemidiaphragm thickness at Tins and Tins-exp (d = 0.38-053), and right and left PPT (d = 0.71-0.74) versus the IMT group. The interaction with sex was statistically significant (p = 0.007; F(1,81) = 7.756; ηp 2 = 0.087) and higher left hemidiaphragm thickness at Tins was predicted by the BFB + IMT group (R 2 = 0.099; ß = 0.050; F(1,82) = 8.997; p = 0.004) and male sex (R 2 = 0.079; ß = 0.045; F(1,81) = 7.756;p = 0.007). Furthermore, greater left hemidiaphragm thickness at Tins-exp was predicted by younger age (R 2 = 0.052; ß = -0.001; F(1,82) = 4.540; p = 0.036). Discussion: The simultaneous bilateral visual diaphragm biofeedback by ultrasonography in conjunction with IMT was effective in both increasing the left diaphragmatic thickness during inspiration, which was positively influenced and predicted by male sex and younger age, and increasing the bilateral PPT of the paraspinal muscles in patients with NSLBP.
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The aim of the present study was to determine the gender respiratory differences of bilateral diaphragm thickness, respiratory pressures, and pulmonary function in patients with low back pain (LBP). A sample of 90 participants with nonspecific LBP was recruited and matched paired by sex (45 women and 45 men). Respiratory outcomes included bilateral diaphragm thickness by ultrasonography, respiratory muscle strength by maximum inspiratory (MIP) and expiratory (MEP) pressures, and pulmonary function by forced expiratory volume during 1 s (FEV1), forced vital capacity (FVC) and FEV1/FVC spirometry parameters. The comparison of respiratory outcomes presented significant differences (p < 0.001), with a large effect size (d = 1.26-1.58) showing means differences (95% CI) for MIP of -32.26 (-42.99, -21.53) cm H2O, MEP of -50.66 (-64.08, -37.25) cm H2O, FEV1 of -0.92 (-1.18, -0.65) L, and FVC of -1.00 (-1.32, -0.69) L, with lower values for females versus males. Gender-based respiratory differences were presented for maximum respiratory pressures and pulmonary function in patients with nonspecific LBP. Women presented greater inspiratory and expiratory muscle weakness as well as worse lung function, although these differences were not linked to diaphragm thickness during normal breathing.
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Diafragma , Dor Lombar , Ultrassonografia , Humanos , Masculino , Feminino , Diafragma/diagnóstico por imagem , Diafragma/fisiopatologia , Dor Lombar/diagnóstico por imagem , Dor Lombar/fisiopatologia , Ultrassonografia/métodos , Adulto , Pessoa de Meia-Idade , Fatores Sexuais , Testes de Função Respiratória , Pulmão/diagnóstico por imagem , Pulmão/fisiopatologia , Espirometria , Força Muscular/fisiologia , Capacidade Vital/fisiologia , Volume Expiratório Forçado/fisiologiaRESUMO
STUDY DESIGN: Retrospective cohort study. OBJECTIVE: Compare perioperative adverse events and reoperations between navigation-assisted and robotic-assisted posterior lumbar fusion. SUMMARY OF BACKGROUND DATA: Navigation has become increasingly utilized for posterior lumbar fusion (PLF). More recently, robotic assistance systems have been gaining traction. However, the incremental advantage of these systems has been unclear in the literature. METHODS: Patients undergoing one to three level PLF (with or without anterior or posterior interbody fusion) were identified from the 2015-2022 M161Ortho PearlDiver Database using CPT codes. Navigation assistance was identified based on CPT coding and robotic assistance was based on ICD-10 procedural coding. Navigation-assisted cases were matched 4:1 to robotic assisted patients based on age, sex, Elixhauser Comorbidity Index, number of levels fuse, and concomitant anterior fusion. Incidence of 90-day adverse outcomes were assessed and compared with multivariable logistical regression. Bonferroni correction was applied for multiple testing. Rate of reoperation was assessed using a Kaplan-Meier survival analysis. RESULTS: From 2015 to 2022, there has been a significant increase in both navigation and robotic assisted lumbar fusions, with navigation-assisted surgery being significantly more common. After matching, there were 2,401 navigation-assisted cases and 651 robotic-assisted cases. On multivariate analysis, there no significant differences in 90-day any, severe, or minor adverse events. There was a significant increase odd of readmissions in the robotic cohort (OR: 1.77, P<0.001). There were no differences in three-year reoperation rates between the navigation-assisted and robotic-assisted cohorts (95.8% versus 94.0%, P=0.30). CONCLUSIONS: As spinal navigation has been gaining popularity and robotic assistance is starting to be further utilized, the incremental advantage of different techniques may be questioned. While further study and technique evolution are ongoing, the current study was not able to demonstrate 90-day or 3-year incremental advantages for robotics relative to navigation based on the metrics evaluated.
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Adolescent idiopathic scoliosis is a commonly encountered condition often diagnosed on screening examination. Underlying, asymptomatic neural axis abnormalities may be present at the time of diagnosis. At certain institutions, total spine MRI is obtained preoperatively to identify these abnormalities. We provide a framework for the radiologist to follow while interpreting these studies. In part 1, we discuss Arnold Chiari malformations, syringomyelia, and the tethered cord. In part 2, we focus on spinal cord tumors, dysraphisms, to include diastematomyelia, and vertebral anomalies.
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Malformação de Arnold-Chiari , Escoliose , Siringomielia , Humanos , Adolescente , Escoliose/diagnóstico por imagem , Escoliose/cirurgia , Malformação de Arnold-Chiari/diagnóstico por imagem , Malformação de Arnold-Chiari/cirurgia , Imageamento por Ressonância Magnética , Siringomielia/diagnóstico por imagem , Siringomielia/cirurgia , Programas de Rastreamento , Coluna Vertebral/diagnóstico por imagem , Coluna Vertebral/cirurgiaRESUMO
Adolescent idiopathic scoliosis is a commonly encountered condition often diagnosed on screening examination. Underlying, asymptomatic neural axis abnormalities may be present at the time of diagnosis. At certain institutions, total spine MRI is obtained preoperatively to identify these abnormalities. We provide a framework for the radiologist to follow while interpreting these studies. In part 1, we discuss Arnold Chiari malformations, syringomyelia, and the tethered cord. In part 2, we focus on spinal cord tumors, dysraphisms, to include diastematomyelia, and vertebral anomalies.
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Malformação de Arnold-Chiari , Defeitos do Tubo Neural , Escoliose , Neoplasias da Medula Espinal , Humanos , Adolescente , Escoliose/diagnóstico por imagem , Escoliose/cirurgia , Defeitos do Tubo Neural/diagnóstico por imagem , Defeitos do Tubo Neural/patologia , Malformação de Arnold-Chiari/diagnóstico por imagem , Malformação de Arnold-Chiari/patologia , Imageamento por Ressonância Magnética , Neoplasias da Medula Espinal/patologia , Medula Espinal/diagnóstico por imagem , Coluna Vertebral/patologiaRESUMO
STUDY DESIGN/SETTING: Retrospective study. OBJECTIVE: To understand why patients utilize emergency departments (EDs) versus urgent care centers for low back pain (LBP). SUMMARY OF BACKGROUND DATA: LBP is a common reason for ED visits. In the setting of trauma or recent surgery, the resources of EDs may be needed. However, urgent care centers may be appropriate for other cases. MATERIALS AND METHODS: Adult patients below 65 years of age presenting to the ED or urgent care on the day of diagnosis of LBP were identified from the 2019 PearlDiver M151 administrative database. Exclusion criteria included history of radiculopathy or sciatica, spinal surgery, spinal cord injury, other traumatic, neoplastic, or infectious diagnoses in the 90 days prior, or Medicare insurance. Patient age, sex, Elixhauser comorbidity index, geographic region, insurance, and management strategies were extracted. Factors associated with urgent care relative to ED utilization were assessed using multivariable analysis. RESULTS: Of 356,284 LBP patients, ED visits were identified for 345,390 (96.9%) and urgent care visits for 10,894 (3.1%). Factors associated with urgent care use relative to the ED were: geographic region [relative to Midwest; Northeast odds ratio (OR): 5.49, South OR: 1.54, West OR: 1.32], insurance (relative to Medicaid; commercial OR: 4.06), lower Elixhauser comorbidity index (OR: 1.28 per two-point decrease), and higher age (OR: 1.10 per decade), female sex (OR: 1.09), and use of advanced imaging (OR: 0.08) within 1 week ( P <0.001 for all). CONCLUSIONS: Most patients presenting for a first diagnosis of isolated LBP went to the ED relative to urgent care. The greatest drivers of urgent care versus ED utilization for LBP were insurance type and geographic region. Utilization of advanced imaging was higher among ED patients, but rates of surgical intervention were similar between those seen in the ED and urgent care.
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Dor Lombar , Medicare , Adulto , Humanos , Feminino , Idoso , Estados Unidos/epidemiologia , Estudos Retrospectivos , Dor Lombar/diagnóstico , Dor Lombar/epidemiologia , Dor Lombar/terapia , Serviço Hospitalar de Emergência , Assistência AmbulatorialRESUMO
Imaging plays an important role in the diagnosis of spinal infections. Early diagnosis is paramount in the treatment of spinal infections and leads to improved outcomes. This article reviews the imaging and relevant clinical details of infections of the spine: pyogenic spondylodiscitis, tuberculous spondylodiscitis, septic facet arthritis, epidural abscess, and subdural abscess. Though radiographs can reveal subtle changes with infections, advanced imaging modalities have increased sensitivity to aid in early diagnosis. Magnetic resonance imaging (MRI) is emphasized given it is generally the most sensitive and specific advanced imaging modality. However, nuclear medicine imaging and computer tomography (CT) play a role diagnosis in cases where MRI is not available or contra-indicated. Additionally, CT is also important for image-guided biopsy to guide antimicrobial treatment.
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Background: The diaphragm is considered the main muscle involved in breathing and also linked to trunk stabilization functions. Up to date, rehabilitative ultrasound imaging (RUSI) has been the most used technique to evaluate unilaterally the transcostal diaphragm thickness. Nevertheless, the inspiratory activity of both hemi-diaphragms is bilaterally performed at the same time, and its simultaneous evaluation with a thoracic orthosis could improve its assessment as well as its re-education with visual biofeedback of both hemi-diaphragms at the same time. The purpose was to evaluate the reliability and repeatability of simultaneous thickness measurements of both hemi-diaphragms bilaterally during normal breathing using a thoracic orthosis that allowed bilateral fixation of both right and left ultrasound probes. Methods: The study was conducted in 46 healthy subjects, whose diaphragm thickness was measured bilaterally and simultaneously in the anterior axillary line during relaxed breathing with a designed thoracic orthosis and 2 ultrasound tools. Intra-examiner (same examiner), inter-examiner (2 examiners), intra-session (1 hour) and inter-session (1 week) reliability and repeatability between each pair of measurements of diaphragm muscle thickness were analyzed during normal breathing. Results: Reliability and repeatability for intra-session evaluations using the thoracic orthosis were excellent to evaluate simultaneous thickness of both hemi-diaphragms by bilateral probes fixation (intraclass correlation coefficient =0.919-0.997; standard error of measurement =0.002-0.007 cm; minimum detectable change =0.006-0.020 cm), without systematic errors (P>0.05) between each pair of measurements. Nevertheless, inter-session evaluations varied from good to excellent using the bilateral probes fixation (intraclass correlation coefficient =0.614-0.984; standard error of measurement =0.006-0.028 cm; minimum detectable change =0.017-0.079 cm), although some systematic errors were presented (P<0.05). Conclusions: Good to excellent reliability and repeatability was shown for simultaneous thickness measurements of both hemi-diaphragms bilaterally during normal breathing. Despite systematic errors were presented for some inter-examiner assessments, the use of the thoracic orthosis that allowed bilateral fixation of ultrasound probes could be recommended for simultaneous hemi-diaphragms breathing re-education by visual biofeedback.
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BACKGROUND CONTEXT: Morbid obesity (MO) has been associated with increased risk of adverse events following procedures such as posterior lumbar fusion (PLF). While preemptive bariatric surgery (BS) has been considered for those with MO (body mass index [BMI] ≥35 kg/m2), not all undergoing such intervention have significant weight loss, and the impact of BS has been shown to correlate with weight loss after different related procedures. PURPOSE: To examine outcomes following isolated single level PLF among patients with history of BS who subsequently did and did not transition out of the morbidly obese category. STUDY DESIGN/SETTING: Retrospective case-control study. PATIENT SAMPLE: The PearlDiver 2010-Q1 2020 MSpine database was used to identify adult patients undergoing elective isolated PLF. Patients were excluded if they had a history of infection, neoplasm, or trauma in the 90-days prior to their PLF and if they were not active in the database for at least 90 days following their surgery. Three sub-cohorts were defined: 1) MO controls without a history of BS (-BS+MO), 2) patients with prior BS procedure who remained MO (+BS+MO), and 3) patients with prior BS who were no longer MO at the time of PLF (+BS-MO). Matched 1:1:1 populations were created for these three sub-cohorts based on age, sex and Elixhauser Comorbidity Index (ECI). OUTCOME MEASURES: Ninety-day adverse events and readmission rates were assessed and compared between the three sub-cohorts (-BS+MO, +BS+MO, +BS-MO). METHODS: Univariable analyses and multivariable logistic regression were performed on the matched population to compare 90-day adverse events and readmission rates controlling for age, sex, and ECI. RESULTS: The current study identified PLF patients who were MO at the time of surgery but did not have a history of BS (-BS+MO, n=34,236), those who had BS and remained MO (+BS+MO, n=564), and those who had MS and were no longer MO (+BS-MO, n=209 which was only 27% of those who had BS). On multivariable analysis of the matched populations, those that had BS but remained MO (+BS+MO) were not at reduced odds of 90-day adverse events. However, those that had BS and were no longer MO (+BS-MO) were at reduced odds of 90-day any, severe, and minor adverse events (OR 0.41, 0.51, and 0.37, respectively with p<0.05 for all). CONCLUSIONS: Only 27% of those with a history of BS prior to PLF transitioned out of the MO category. Compared to those who were morbidly obese without BS, those who had BS were only at reduced risk of 90-day adverse events if they actually lost weight sufficient to drop out of morbidly obesity. These findings should be taken into account when counseling patients and interpreting prior studies.
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Cirurgia Bariátrica , Obesidade Mórbida , Fusão Vertebral , Adulto , Humanos , Estudos Retrospectivos , Estudos de Casos e Controles , Obesidade Mórbida/cirurgia , Obesidade Mórbida/complicações , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/etiologia , Cirurgia Bariátrica/efeitos adversos , Redução de Peso , Fusão Vertebral/efeitos adversos , Fusão Vertebral/métodosRESUMO
INTRODUCTION: Incidental durotomies can occur during posterior lumbar decompression surgery. Not only can this slow patient recovery but many surgeons recommend a period of bed rest in these situations, which can further slow mobilization. This immobility might be associated with increased risk of venous thromboembolism (VTE) after spinal surgery. This study aims to determine whether incidental durotomies are associated with increased risk of VTE in patients undergoing lumbar decompression surgery. METHODS: Adult patients undergoing laminectomy or laminotomy (excluding any with concomitant fusion procedures) for degenerative etiologies and with a minimum of 90-day follow-up were identified from the MSpine Pearldiver dataset. Incidental durotomies were identified based on hospital administrative coding, and patient demographics, comorbidities, and the occurrence and timing of VTE (deep vein thrombosis [DVT] and/or pulmonary embolism) were defined. Univariate and multivariate analyses were performed. RESULTS: Of 156,488 lumbar decompression patients included in the study, incidental durotomies was noted for 2,036 (1.3%). Markedly more VTEs were observed in the first five days in the incidental durotomies group ( P < 0.001) but not incrementally any day after ( P > 0.05). On univariate analyses, a significant increased risk of VTE, DVT, and PE was observed ( P < 0.001 for each). On multivariate analyses controlling for age, sex, and comorbidities, odds were significantly increased for VTE (Odds ratios = 1.75, P < 0.001) and DVT (OR = 1.70, P < 0.001) but not independently significant for pulmonary embolism. DISCUSSION: Patients who have incidental durotomies during lumbar laminectomy or laminotomy surgery were found to have increased odds of VTE, primarily in the first five days. Although not all factors associated with this could be directly determined, slower mobilization would seem to be a likely contributing factor. Increasing mobilization and/or adjusting chemoprophylaxis in this group would seem appropriately considered.
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Embolia Pulmonar , Tromboembolia Venosa , Adulto , Humanos , Tromboembolia Venosa/epidemiologia , Tromboembolia Venosa/etiologia , Tromboembolia Venosa/prevenção & controle , Fatores de Risco , Estudos Retrospectivos , Incidência , Embolia Pulmonar/epidemiologia , Descompressão/efeitos adversosRESUMO
Cytotoxic T-lymphocytes (CTL) are a subset of T-cells that play a critical role in protecting against intracellular infections and cancer, and have the ability to identify and kill infected or transformed cells expressing non-self peptides associated with major histocompatibility (MHC) Class I molecules. Conversely, aberrant CTL activity can contribute to immune-related pathology under conditions of overwhelming infection or autoimmunity. Disease-modifying therapeutics can have unintended effects on CTL, and a growing number of therapeutics are intended to either suppress or enhance CTL or their functions. The susceptibility of CTL to unintended effects from common therapeutic modalities underscores the need for a better understanding of the impact that such therapies have on CTL function and the associated safety implications. While there are reliable ways of quantifying CTL, notably via flow cytometric analysis of specific CTL markers, it has been a greater challenge to implement fit-for-purpose methods measuring CTL function in the context of safety studies of therapeutics. This review focuses on methods for measuring CTL responses in the context of drug safety and pharmacology testing, with the goals of informing the reader about current approaches, evaluating their pros and cons, and providing perspectives on the utility of these approaches for safety evaluation.
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Neoplasias , Linfócitos T Citotóxicos , Animais , Primatas , Neoplasias/terapia , Citotoxicidade ImunológicaRESUMO
BACKGROUND CONTEXT: Following spine surgery, postoperative surgical site infection (SSI) is a rare but potentially devastating complication. Previous studies have assessed risk factors for spine SSI and one aimed to develop risk stratification tool to assess management options, but this tool has not been externally validated or regularly used. PURPOSE: The current study aimed to investigate the rate of SSI following elective spine surgery, surgical management pursued, and success of traditionally utilized one-stage of irrigation and debridement (I&D) with closure over drains. STUDY DESIGN: Retrospective case-control study. PATIENT SAMPLE: Adult, elective spine surgeries performed at a single academic institution between 2013 and 2021 were evaluated. Patients who developed SSI requiring surgical intervention were identified. OUTCOME MEASURES: Those who underwent initial management with I&D and closure over drains were assessed for need of subsequent I&D (considered failure of initial infection management). METHODS: Of spine surgeries meeting inclusion criteria, those with SSI were identified and management was characterized. For those who did and did not fail attempted one stage I&D with closure over drains, pre-operative and surgical variables from the index procedure as well as infection characteristics were assessed and compared with univariable and multivariable analyses. RESULTS: Of 11,023 elective spine surgeries, SSI was identified for 76 (0.7%). For initial management, I&D with closure over drains was used for 66 (86.8%) while I&D and wound vacuum management was used 10 (13.2%). Failure of attempted one stage I&D (requiring subsequent I&D procedure) was identified for 18 (27% of those undergoing I&D and closure over drains). Of multiple patient, surgical, and infection characteristics, the only factor identified as independently predictive of one stage I&D failure was presence of bacteremia (odds ratio [OR] 38.3, p=0.0007). Within the sub-cohort of patients with bacteremia, failure of attempted one stage I&D was noted for 80%. CONCLUSION: Less than one percent of a large cohort of patients undergoing spine surgery were found to develop SSIs. Of those undergoing attempted one stage I&D, most patient, surgical, and infection variables did not influence outcome of the intervention. However, those with bacteremia were at 38.3 times greater odds of failing attempted one-stage I&D. These results suggest considering delayed closure approaches in these cases.
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Coluna Vertebral , Infecção da Ferida Cirúrgica , Adulto , Humanos , Infecção da Ferida Cirúrgica/epidemiologia , Infecção da Ferida Cirúrgica/etiologia , Desbridamento/efeitos adversos , Estudos Retrospectivos , Estudos de Casos e Controles , Coluna Vertebral/cirurgia , Fatores de RiscoRESUMO
Introducción: La enfermedad del Zika es causada por el virus de igual nombre, un arbovirus transmitido principalmente por la picadura del mosquito Aedes. Existe riesgo de reintroducción y circulación autóctona del virus Zika en Cuba, por tanto, constituye una problemática vigente. Objetivo: Caracterizar el comportamiento clínico de la infección por virus Zika en pacientes ingresados en el Instituto de Medicina Tropical Pedro Kourí (IPK). Método: Se realizó un estudio descriptivo de corte trasversal con componente analítico, en pacientes con diagnóstico de Zika ingresados en el IPK en el periodo de noviembre de 2016 a mayo de 2017. Se analizaron variables sociodemográficas, clínicas, biomédicas y microbiológicas. Resultados: En los pacientes confirmados con virus Zika, las manifestaciones clínicas significativas (p ≤ 0,05) fueron prurito y adenomegalias; con una duración de la erupción cutánea significativamente superior. En cuanto a los estudios de confirmación mediante reacción en cadena de la polimerasa en tiempo real, la muestra de orina tuvo valores de positividad significativamente superiores a las de suero desde el comienzo del cuadro clínico. Conclusiones: Los casos autóctonos de Zika estudiados presentaron un cuadro clínico donde predominaron el prurito y las adenomegalias. Esto permitió realizar un diagnóstico presuntivo y diferencial ante otros pacientes con síndrome febril. El diagnóstico microbiológico para confirmación de esta arbovirosis fue realizado mediante técnicas moleculares. En la mayoría de los casos las muestras de orina demostraron ser de gran utilidad desde los primeros días luego de la fecha de inicio de los síntomas.
Introduction: Zika is caused by the virus of the same name, an arbovirus transmitted mainly by the bite of the Aedes mosquito. The risk of reintroduction and autochthonous circulation of Zika virus in Cuba remains; therefore, it is considered a current problem. Objective: To characterize the clinical behavior of Zika virus infection in patients admitted to the Institute of Tropical Medicine Pedro Kourí (IPK). Methods: It was conducted a cross-sectional, descriptive study with an analytic component in patients with a diagnosis of Zika admitted to IPK from November 2016 to May 2017. Sociodemographic, clinical, biomedical and microbiological variables were analyzed. Results: In patients confirmed with Zika virus, the main clinical manifestations (p≤ 0.05) were pruritus and adenomegaly; with significantly longer duration of rash. Regarding confirmation studies by real-time polymerase chain reaction, the urine sample had significantly higher positivity values than the serum samples from the onset of the clinical picture. Conclusions: Pruritus and adenomegaly prevailed in the autochthonous cases of Zika under study. This allowed conducting a presumptive and differentiated diagnosis to other patients with a febrile syndrome. The microbiological diagnosis to confirm this arbovirus was performed by molecular methods. In the majority of cases, the urine samples were very useful from the first days after the onset of the symptoms.
Assuntos
HumanosRESUMO
Background: With increasing emphasis on patient satisfaction metrics, such as the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey, hospital reputations and reimbursements are being affected by their results. The purpose of the current study is to determine if post-operative self-reported patient satisfaction differed among patients who experienced any adverse event (AAE) following elective posterior lumbar fusion (PLF) surgery compared to those who did not. Methods: Patients who underwent elective PLF surgery performed at a single institution between February 2013 and May 2020 and returned an HCAHPS survey following discharge were included in the retrospective cohort analysis. Demographic, comorbidity, and HCAHPS survey data were compared between patients who did and did not experience any adverse event (AAE) in the 30-days postoperatively. Results: Of 5,117 PLF patients, the HCAHPS survey was returned by 1,071 patients, of which 30-day AAE was experienced by 40 (3.73%). Of those that experienced AAE, the survey response rate was significantly lower (13.94% versus 21.35%, p=0.003). Those responding reported lower scores pertaining to if medication side-effects were adequately explained (22.22% versus 52.56%, p=0.002) and if post-discharge care was adequately explained (79.17% versus 93.76%, p=0.005), as well as overall top-box responses (67.62% versus 75.93% survey average, p<0.001). Conclusions: Patients experiencing AAE after elective PLF surgery are less likely to respond to surveys about their hospital experience. For those who did respond, they report less satisfaction with multiple aspects of their hospital care measured by the HCAHPS survey. Understanding how postoperative adverse events impact patients' perception of healthcare quality provides insight into what patients value and has implications for optimizing their care.
RESUMO
Introduction: The dengue case classifications proposed by World Health Organization (WHO, 2009) include warning signs (WS) for recognizing early progression of disease toward the critical phase. Objective: To analyze the usefulness WS and challenges of the 2009 WHO dengue case classification in preventing and managing severe dengue cases. Methods: Data from 1439 adult patients diagnosed as dengue cases (2001-2002, 2006, 2012) at the Pedro Kourí Institute Hospital, in Havana Cuba, was revised. The WS were described and their predictive utility was considered in preventing shock in these patients with the use of crystalloids by calculating the sensitivity, specificity and positive / negative predictive values using both the 1997 and 2009 WHO dengue case classifications. Results: Plasma-leakage with shock was the main clinical form of severe dengue (95.3 percent). All severe cases due to plasma leakage had WS. The most frequent WS were mucosal bleeding (926 cases; 64.4 percent), frequent vomiting (361; 39.0 percent), abdominal pain or tenderness (404; 35.5 percent) and prostration (408; 28.4 percent). Mucosal bleeding and abdominal pain were good predictors of severity, appearing one day before shock. More than 75 percent of patients without WS there were not severe dengue. Most patients with warning signs were managed correctly and had an uneventful recovery. Conclusions: Identifying the WS recommended by WHO 2009 classification for crystalloid intravenous fluid treatment was crucial for the successful outcome of dengue cases(AU)
Introducción: La clasificación de dengue propuesta por la Organización Mundial de la Salud (OMS) en el 2019 incluye los signos de alarma (SA) para reconocer la rápida progresión de la enfermedad a la fase crítica. Objetivo: Analizar la utilidad de los SA y los retos de la clasificación de la OMS de 2009 para la prevención y manejo de los casos graves de dengue. Métodos: Se obtuvo información de 1439 pacientes adultos diagnosticados como casos de dengue (años: 2001-2002, 2006, 2012) en el Hospital del Instituto Pedro Kourí, en La Habana, Cuba. Se describieron los SA y se consideró su utilidad en la prevención del choque con el uso de soluciones cristaloides mediante el cálculo de la sensibilidad, especificidad y los valores positivo y negativo a partir de las clasificaciones de la OMS de 1997 y 2009. Resultados: La extravasación de plasma con choque fue la forma clínica principal del dengue grave (95,3 por ciento). Todos los casos graves debido a extravasación de plasma manifestaron SA. Los SA más frecuentes fueron el sangrado de mucosas (926 casos; 64,4 por ciento), los vómitos frecuentes (361; 39,0 por ciento), el dolor abdominal espontáneo o a la palpación (404; 35,5 por ciento) y la postración (408; 28,4 por ciento). El sangrado de mucosas y el dolor abdominal fueron buenos predictores de gravedad (aparecieron un día antes del choque). Más del 75 por ciento de los pacientes sin SA no tenían dengue grave. La mayoría de los pacientes con SA fueron tratados correctamente y se recuperaron sin complicaciones. Conclusiones: La identificación de SA recomendada por la clasificación de OMS de 2009 para el tratamiento con cristaloides fue crucial para la evolución exitosa de los casos de dengue(AU)