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1.
Artículo en Inglés | MEDLINE | ID: mdl-39025664

RESUMEN

PURPOSE: To determine whether dropless, injection-based cataract surgery prophylaxis with intracameral antibiotic and subconjunctival steroid may reduce healthcare system costs and patient out-of-pocket costs compared to topical medication regimens. SETTING: United States national medical expenditures database. DESIGN: Retrospective cost analysis. METHODS: Costs were analyzed for topical ophthalmics from the 2020 Medical Expenditure Panel Survey (MEPS) and for dropless medications from pharmaceutical invoices/catalogs. Main outcomes included system costs, from insurance and patient payments, and out-of-pocket costs for cataract surgery topical and dropless, injection-based prophylactic medication regimens, per eye and nationally. System costs for individual topical medications and same-class dropless, injection-based medications were compared using two-sided, one-sample t-tests. RESULTS: There were 583 prophylactic topical ophthalmic purchases in MEPS. Mean system costs per eye were $76.20 ± SD 39.07 for the lowest cost topical steroid (prednisolone) compared to $4.01 for the lowest cost subconjunctival steroid (triamcinolone acetonide) (p < 0.001). Per eye, the lowest cost dropless, injection-based regimen, at $15.91, results in an $87.99 (84.7%) reduction in overall healthcare costs and a $43.64 (100%) reduction in patient out-of-pocket costs relative to the lowest cost topical regimen ($103.90 ± 43.14 mean system cost and $43.64 ± 37.32 mean out-of-pocket cost per eye). Use of intracameral moxifloxacin and subconjunctival triamcinolone acetonide can reduce annual national healthcare system and out-of-pocket costs up to $450,000,000 and $225,000,000, respectively. CONCLUSIONS: An evidence-based cataract surgery prophylactic medication regimen of intracameral moxifloxacin and subconjunctival triamcinolone acetonide can reduce healthcare system and patient out-of-pocket costs in comparison to various topical regimens.

2.
Ophthalmology ; 2024 Apr 04.
Artículo en Inglés | MEDLINE | ID: mdl-38582155

RESUMEN

PURPOSE: To compare the effectiveness and safety of a single injection of subconjunctival triamcinolone acetonide (TA) with that of postoperative topical prednisolone acetate (PA) with and without nonsteroidal anti-inflammatory drugs (NSAIDs) for cataract surgery prophylaxis. DESIGN: Retrospective, comparative effectiveness cohort study. PARTICIPANTS: Patients at Kaiser Permanente Northern California from 2018 through 2021. INTERVENTION: Exposure groups included topical PA with or without NSAID and subconjunctival injection of TA (Kenalog; Bristol-Myers-Squibb) 10 mg/ml or 40 mg/ml in a low dose (1.0-3.0 mg) or high dose (3.1-5.0 mg). MAIN OUTCOME MEASURES: The adjusted odds ratio (OR) and 95% confidence interval (CI) for the association of postoperative macular edema (ME) and iritis diagnoses 15 to 120 days after surgery (effectiveness measures) and a glaucoma-related event (safety measure) between 15 days and 1 year after surgery. RESULTS: Of 69 832 eligible patient-eyes, postoperative ME, iritis, and a glaucoma-related event occurred on average in 1.3%, 0.8%, and 3.4% of eyes in the topical groups and 0.8%, 0.5%, and 2.8% of eyes in the injection groups, respectively. In multivariable analysis, compared with the PA reference group, the PA plus NSAID group had a lower OR of ME (OR, 0.88; 95% CI, 0.74-1.04; P = 0.135). and all injection groups had even lower odds, with the high-dose TA 10-mg/ml group reaching statistical significance (OR, 0.64; 95% CI, 0.43-0.97; P = 0.033). A trend of lower odds of a postoperative iritis diagnosis was noted in the high-strength (40 mg/ml) groups. For postoperative glaucoma-related events, compared with PA, the TA 10-mg/ml low-dose group showed lower odds (OR, 0.69; 95% CI, 0.55-0.86; P = 0.001), the TA 10-mg/ml high-dose group showed similar odds (OR, 0.90; 95% CI, 0.70-1.15; P = 0.40), and the TA 40-mg/ml low-dose and high-dose groups showed higher odds of an event occurring (OR, 1.46 [95% CI, 0.98-2.18; P = 0.062] and OR, 2.14 [95% CI, 1.36-3.37; P = 0.001], respectively). CONCLUSIONS: The TA 10-mg/ml high-dose (4 mg) group was associated with a lower risk of postoperative ME and a similar risk of glaucoma-related events compared with the topical groups. FINANCIAL DISCLOSURE(S): The author(s) have no proprietary or commercial interest in any materials discussed in this article.

3.
BMC Med Educ ; 23(1): 665, 2023 Sep 14.
Artículo en Inglés | MEDLINE | ID: mdl-37710292

RESUMEN

BACKGROUND: Ultrasound Guided Regional Anesthesia (UGRA) has become the standard for regional anesthesia practice, but there is not a standardized educational approach for training residents. The objective of this study was to evaluate the efficacy of an UGRA workshop utilizing the theoretical framework of embodied cognition for anesthesiology residents. METHODS: A workshop was developed consisting of didactics, scanning training on standardized patients (SPs) and anatomy reviews on prosected cadavers that focused on the most common UGRA procedures for the upper and lower extremity. At the beginning of the workshop and at the end of the workshop residents completed pre-test and pre-confidence surveys, as well as post-test and post-confidence surveys, respectively to assess the impact of the workshop. RESULTS: 39 residents (100% of the possible residents) participated in the workshop in 2019. Residents' confidence in identifying relevant anatomy for the most common UGRA procedures significantly increased in 13 of the 14 measurements. Residents' knowledge gain was also statistically significant from the pre-test to post-test (20.13 ± 3.61 and 26.13 ± 2.34; p < .0001). The residents found the course overall to be very useful (4.90 ± 0.38) and in particular the cadaveric component was highly rated (4.74 ± 0.55). CONCLUSIONS: In this study, we developed a workshop guided by the embodied cognition framework to aid in shortening the overall learning curve of UGRA for anesthesiology residents. Based on our results this workshop should be replicated by institutions that are hoping to decrease the learning curve associated with UGRA and increase residents' confidence in identifying the relevant anatomy in UGRA nerve blocks.


Asunto(s)
Anestesia de Conducción , Cognición , Humanos , Ultrasonografía , Ultrasonido , Escolaridad
4.
J Cataract Refract Surg ; 49(10): 1068-1070, 2023 10 01.
Artículo en Inglés | MEDLINE | ID: mdl-37290753

RESUMEN

Moxifloxacin solution is frequently injected at the conclusion of cataract surgery for endophthalmitis prophylaxis. 2 different concentrations are most commonly available in the United States for intracameral (IC) use: 0.5% (5 mg/mL) and 0.1% (1 mg/mL). The recommended volume to be injected is different for the 2 concentrations, and incorrect dosing can increase the risk of toxic anterior segment syndrome or endophthalmitis. In addition, the U.S. Food and Drug Administration recently published an alert regarding potential adverse events associated with intraocular compounded moxifloxacin. This clinical advisory reviews the optimal dosing of IC moxifloxacin based on current evidence.


Asunto(s)
Extracción de Catarata , Endoftalmitis , Infecciones Bacterianas del Ojo , Humanos , Moxifloxacino , Antibacterianos/uso terapéutico , Profilaxis Antibiótica , Endoftalmitis/tratamiento farmacológico , Infecciones Bacterianas del Ojo/prevención & control , Infecciones Bacterianas del Ojo/tratamiento farmacológico , Cámara Anterior , Complicaciones Posoperatorias/prevención & control
5.
J Vasc Interv Radiol ; 34(9): 1477-1484, 2023 09.
Artículo en Inglés | MEDLINE | ID: mdl-37207812

RESUMEN

PURPOSE: To evaluate the efficacy of sacroplasty for treating sacral insufficiency fractures, including the effect on pain relief, patient function and adverse event rates in an as-treated on-label prospective data registry. MATERIALS AND METHODS: Observational data including patient reported outcomes (PROs), patient characteristics, osteoporosis treatment, fracture duration, cause of sacral fractures and image guidance used for treatment were collected for patients undergoing sacroplasty. The PROs were collected at baseline then at one, three, and at six months following the procedure. The primary outcomes were pain as measured by the Numerical Rating Scale (NRS) and function as measured by the Roland Morris Disability Questionnaire (RMDQ). Secondary outcomes included adverse events, cement leakage, new neurologic events, readmissions and death. RESULTS: The interim results for the first 102 patients included significant pain reduction with mean pain improvement scores at six months decreasing from 7.8 to 0.9 (P < .001) and significant improvement in function with mean RMDQ scores improving from 17.7 to 5.2 (P < .001). Most procedures were performed under fluoroscopy (58%). There was cement leakage in 17.7% of the subjects but only one adverse event which was a new neurologic deficit related to cement extravasation. The readmission rate was 16% mostly due to additional back pain and fractures and there were no subject deaths. CONCLUSIONS: Sacroplasty with cement augmentation for acute, subacute and chronic painful sacral insufficiency fractures caused by osteoporosis or neoplastic disorders results in highly significant improvements in pain and function with very low rate of procedural related adverse events.


Asunto(s)
Fracturas por Estrés , Osteoporosis , Fracturas de la Columna Vertebral , Humanos , Fracturas por Estrés/inducido químicamente , Fracturas por Estrés/complicaciones , Estudios Prospectivos , Resultado del Tratamiento , Fracturas de la Columna Vertebral/diagnóstico por imagen , Fracturas de la Columna Vertebral/cirugía , Cementos para Huesos/efectos adversos , Dolor de Espalda , Sistema de Registros , Sacro/diagnóstico por imagen , Sacro/cirugía , Sacro/lesiones
6.
Anesth Analg ; 135(4): 697-703, 2022 10 01.
Artículo en Inglés | MEDLINE | ID: mdl-36108183

RESUMEN

ADDENDUM: Please note that in the interim since this paper was accepted for publication, new governmental regulations, pertinent to the topic, have been approved for implementation. The reader is thus directed to this online addendum for additional relevant information: http://links.lww.com/AA/E44.


Asunto(s)
Anestesia , Anestesiología , Humanos
9.
Front Neurol ; 12: 635259, 2021.
Artículo en Inglés | MEDLINE | ID: mdl-33767662

RESUMEN

Vestibular and optokinetic space is represented in three-dimensions in vermal lobules IX-X (uvula, nodulus) and hemisphere lobule X (flocculus) of the cerebellum. Vermal lobules IX-X encodes gravity and head movement using the utricular otolith and the two vertical semicircular canals. Hemispheric lobule X encodes self-motion using optokinetic feedback about the three axes of the semicircular canals. Vestibular and visual adaptation of this circuitry is needed to maintain balance during perturbations of self-induced motion. Vestibular and optokinetic (self-motion detection) stimulation is encoded by cerebellar climbing and mossy fibers. These two afferent pathways excite the discharge of Purkinje cells directly. Climbing fibers preferentially decrease the discharge of Purkinje cells by exciting stellate cell inhibitory interneurons. We describe instances adaptive balance at a behavioral level in which prolonged vestibular or optokinetic stimulation evokes reflexive eye movements that persist when the stimulation that initially evoked them stops. Adaptation to prolonged optokinetic stimulation also can be detected at cellular and subcellular levels. The transcription and expression of a neuropeptide, corticotropin releasing factor (CRF), is influenced by optokinetically-evoked olivary discharge and may contribute to optokinetic adaptation. The transcription and expression of microRNAs in floccular Purkinje cells evoked by long-term optokinetic stimulation may provide one of the subcellular mechanisms by which the membrane insertion of the GABAA receptors is regulated. The neurosteroids, estradiol (E2) and dihydrotestosterone (DHT), influence adaptation of vestibular nuclear neurons to electrically-induced potentiation and depression. In each section of this review, we discuss how adaptive changes in the vestibular and optokinetic subsystems of lobule X, inferior olivary nuclei and vestibular nuclei may contribute to the control of balance.

10.
Am J Ophthalmol ; 227: 166-172, 2021 07.
Artículo en Inglés | MEDLINE | ID: mdl-33571472

RESUMEN

PURPOSE: To estimate the association of cefuroxime and moxifloxacin in relation to the occurrence of endophthalmitis following phacoemulsification cataract surgery. DESIGN: Retrospective clinical cohort study. METHODS: We studied patients with noncomplex phacoemulsification cataract surgery in Kaiser Permanente Northern California during 2014-2019. Data were obtained for acute, postoperative endophthalmitis within 90 days of phacoemulsification, including culture and antibiogram results, intracameral and topical antibiotic agent, and dose. In a post hoc analysis, we also examined preoperative anterior chamber depth (ACD) and postoperative anterior chamber volume (ACV). RESULTS: Of 216,141 surgeries, endophthalmitis occurred in 0.020% of moxifloxacin-injected eyes and 0.013% of cefuroxime eyes (relative risk 1.62 with 95% CI 0.82-3.20, P = .16). Of the 34 (0.016%) cases of endophthalmitis, cefuroxime 1 mg was injected into 13 eyes and moxifloxacin 0.1% into 21 eyes. Organisms with antibiograms were identified in 12 (35%) cases. Of these, bacteria recovered from cefuroxime-injected eyes were resistant to cefuroxime in all cases (4/4), with Enterococcus comprising half of these. In eyes injected with moxifloxacin 0.1%, 6 out of 7 organisms were sensitive to moxifloxacin injected with 0.1 mL and in 1 eye injected with 1 mL. Streptococcus was the most common organism recovered (6/9) in moxifloxacin-injected eyes. Preoperative ACD and postoperative calculated ACV were higher in eyes injected with moxifloxacin. CONCLUSIONS: Endophthalmitis cases with positive cultures were generally related to organism resistance in cefuroxime eyes but to sensitive organisms in moxifloxacin eyes. Moxifloxacin doses may have been insufficient in eyes with larger ACV.


Asunto(s)
Antibacterianos/uso terapéutico , Profilaxis Antibiótica , Cefuroxima/uso terapéutico , Endoftalmitis/microbiología , Infecciones Bacterianas del Ojo/microbiología , Moxifloxacino/uso terapéutico , Facoemulsificación , Cámara Anterior/efectos de los fármacos , Bacterias/aislamiento & purificación , Endoftalmitis/diagnóstico , Endoftalmitis/prevención & control , Infecciones Bacterianas del Ojo/diagnóstico , Infecciones Bacterianas del Ojo/prevención & control , Femenino , Humanos , Inyecciones Intraoculares , Implantación de Lentes Intraoculares , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Insuficiencia del Tratamiento
11.
J Cancer Policy ; 29: 100292, 2021 09.
Artículo en Inglés | MEDLINE | ID: mdl-35559947

RESUMEN

BACKGROUND: Insurance status modifies healthcare access and inequities. The Affordable Care Act expanded Medicaid coverage for people with low incomes in the United States. This study assessed the consequences of this policy change for cancer care after expansion in 2014. METHODS: National Cancer Database (NCDB) public benchmark reports were queried for each malignancy in 2013 and 2016. Furthermore, a systematic search [PubMed, Embase, Scopus and Cochrane] was performed. Data on insurance status, access to cancer screening and treatment, and socioeconomic disparities in these metrics was collected. RESULTS: Two-tailed analysis of the NCDB revealed that 14 out of 18 eligible states had a statistically significant increase in Medicaid-insured patients with cancer after expansion. The average percentage increase was 51 % (13.2-204 %). From the systematic review, 229 studies were identified, 26 met inclusion. All 21 relevant articles reported lower uninsured rates. The average increase of Medicaid-insured patients was 77 % (9.5-230 %) and the average decrease of uninsured rates was 55 % (13.4-73 %). 15 out of 21 articles reported increased access to care. 16 out of 17 articles reported reductions in inequities. CONCLUSION: Medicaid expansion in 2014 increased the number of insured patients with cancer. Expansion also improved access to screening and treatment in most oncologic care, and reduced socioeconomic disparities. Further studies evaluating correlative survival outcomes are needed. POLICY SUMMARY: This study informs debates on expansion of Medicaid in state governments and electorates in the United States, and on health insurance reform broadly, by providing insight into how health insurance can benefit people with cancer while revealing how less insurance coverage could harm patients with cancer before and after their diagnosis. This study also contributes to discussions of health insurance mandates, subsidized coverage for people with low incomes, and covered healthcare services determinations by public and private health insurance providers in other countries.


Asunto(s)
Medicaid , Neoplasias , Humanos , Cobertura del Seguro , Tamizaje Masivo , Neoplasias/diagnóstico , Patient Protection and Affordable Care Act , Estados Unidos
12.
J Cataract Refract Surg ; 47(7): 870-877, 2021 Jul 01.
Artículo en Inglés | MEDLINE | ID: mdl-33315744

RESUMEN

PURPOSE: To compare visual outcomes in patients without a history of macular edema after phacoemulsification using combination topical nonsteroidal anti-inflammatory drug plus prednisolone with prednisolone alone. SETTING: Kaiser Permanente Northern California, USA. DESIGN: Retrospective cohort study. METHODS: Information was obtained from the electronic health record. The first measure of corrected distance visual acuity (CDVA) recorded during the period 3 weeks to 1 year after phacoemulsification was obtained. Confounding factors and clustering of eyes within patients were adjusted using linear mixed effects regression models for the continuous outcome of CDVA improvement and general estimating equations for the dichotomous outcome of 20/20 or better vs 20/25 or worse. RESULTS: The study included 62 700 health plan members of whom 26,309 (42%) used topical prednisolone alone, whereas 36,391 (58%) used combination treatment. The mean within-person change in CDVA from the preoperative measurement to the postoperative measurement was the same (-0.43 logMAR) for patients in the 2 groups. However, the group that received combination treatment was somewhat more likely to achieve CDVA of 20/20 or better (odds ratio 1.24 with 95% CI, 1.20-1.28). CONCLUSIONS: In this large study of cataract surgery patients, a small statistically significant association of combination treatment compared with prednisolone alone was observed.


Asunto(s)
Catarata , Facoemulsificación , Preparaciones Farmacéuticas , Antiinflamatorios no Esteroideos , Catarata/complicaciones , Humanos , Complicaciones Posoperatorias , Prednisolona , Estudios Retrospectivos , Resultado del Tratamiento
13.
Perm J ; 252021 05 19.
Artículo en Inglés | MEDLINE | ID: mdl-35348065

RESUMEN

BACKGROUND: The recent systematic adoption of intracameral antibiotic injection during cataract surgery in Sweden, India, and the US serves as a model for the successful transitioning of local quality improvement initiatives to organization-wide implementation. Although the delivery of eye care in the 3 countries is distinctly organized with differing governances and technological infrastructure, each contains elements of a learning organization (ie, an organization that has adopted a culture of creating, acquiring, and transferring knowledge into practice through system-level and clinician-level change). METHODS: We describe a retrospective and organizational implementation study of intracameral antibiotic injection in Sweden, through the efforts of the National Cataract Registry; in the US by Kaiser Permanente; and in India by the Aravind Eye Hospital System. Leadership structure, training in problem solving, benchmarking, sharing of technical knowledge, and data and workforce engagement are compared. RESULTS: Each of the 3 organizations share the key elements of effective leadership, which values the exchange of ideas in the workforce, training and resourcing for change, and information management in the form of benchmarking and data sharing. In the case of intracameral antibiotic injection, a new technique was identified to improve quality and safety with a reduction in infections as evidence of the success of the programs. CONCLUSION: Committing to a culture of collective learning, and leveraging each stakeholder's personal investment, health-care systems may improve care delivery and set new benchmarks in quality and safety.


Asunto(s)
Antibacterianos , Catarata , Antibacterianos/uso terapéutico , Catarata/tratamiento farmacológico , Humanos , Aprendizaje , Organizaciones , Estudios Retrospectivos
14.
Ophthalmol Glaucoma ; 4(3): 277-285, 2021.
Artículo en Inglés | MEDLINE | ID: mdl-33045424

RESUMEN

PURPOSE: Phacoemulsification has been linked to lowered intraocular pressure (IOP) in patients with glaucoma, ocular hypertension, anatomic narrow angles, and in glaucoma suspects, but the magnitude of change has varied. DESIGN: Retrospective cohort study. PARTICIPANTS: Patients with glaucoma treated from June 2010 through May 2015 who underwent phacoemulsification (surgical group) were matched to patients who did not (nonsurgical group) for age, gender, type of glaucoma, baseline IOP, and number and type of glaucoma medications. METHODS: Electronic medical record information was used to compare the matched surgical and nonsurgical groups. MAIN OUTCOME MEASURES: Change in IOP, change in number of glaucoma medications, and likelihood of a glaucoma procedure within 36 months after phacoemulsification. Intraocular pressure measures were obtained from Goldmann applanation tonometry when available (45%), and otherwise with the iCare tonometer (iCare USA, Raleigh, NC), the Tono-Pen (Reichert Technologies, Depew, NY), noncontact tonometry, and pneumotonometry. RESULTS: Among 16 169 matched pairs, average IOP after the index date was lower in the surgical than nonsurgical group throughout follow-up to 36 months. The difference was greatest during months 1 through 18, during which IOP increased by 0.22 mmHg from 16.49 mmHg in the average nonsurgical patient and decreased by 0.99 mmHg from 16.50 mmHg in the average surgical patient (difference in difference, 1.21 mmHg; 95% confidence interval [CI], 1.12-1.30 mmHg). The difference in difference was greatest for patients with ocular hypertension (2.00 mmHg) and for patients with preoperative IOP of 20 mmHg or more (2.46 mmHg). By 30 to 36 months, 5% (95% CI, 4%-6%) fewer surgical patients used an ophthalmic medication. In the surgical group, the odds of selective laser trabeculoplasty were reduced in patients with ocular hypertension (odds ratio [OR], 0.27; 95% CI, 0.10-0.74) or glaucoma suspects (OR, 0.31; 95% CI, 0.20-0.47), whereas the odds of glaucoma surgery were elevated in surgical patients with primary open-angle glaucoma (OR, 1.48; 95% CI, 1.08-2.01). CONCLUSIONS: The association of phacoemulsification for cataract with IOP reduction was lower than in past referral-based studies. Surgeons should expect to reduce IOP approximately 1 to 2 mmHg with phacoemulsification in patients with preoperative IOP of less than 20 mmHg.


Asunto(s)
Glaucoma de Ángulo Abierto , Facoemulsificación , Estudios de Cohortes , Glaucoma de Ángulo Abierto/cirugía , Humanos , Presión Intraocular , Facoemulsificación/efectos adversos , Estudios Retrospectivos
15.
Front Psychol ; 11: 2106, 2020.
Artículo en Inglés | MEDLINE | ID: mdl-32973633

RESUMEN

A model on the role of character strengths in individual, collective, and species success is proffered. It is derived from viewing character strengths from a species perspective as opposed to one of individual differences/personality psychology. The history of the VIA initiative on character science is overviewed, and results to date are summarized in terms of promoting well-being, helping to accomplish aspirational intentions, and allowing the greater good of the collective to grow. "The character strengths response" is described as the response capacities that character strengths may enable for helping us fulfill the human promise of surviving, thriving, and successfully creating a next-generation so that individuals and the collective flourish while also living in harmonious balance with other species. An argument is presented that there is an urgent need for advancing population-wide psychological maturity to be better prepared to navigate the difficult decisions that accompany growing technological powers, and that the character strengths response warrants special attention of research funding to accomplish this imperative.

16.
J Food Prot ; 83(12): 2095-2101, 2020 Dec 01.
Artículo en Inglés | MEDLINE | ID: mdl-32663264

RESUMEN

ABSTRACT: In August 2008, the Food Safety and Inspection Service of the U.S. Department of Agriculture (USDA) launched a new policy that required publication of a list of retail consignees for the meat and poultry products part of class I recalls, those with the greatest potential impact on public health. In this study, two recall effectiveness measures (recovery rate and completion time) and a difference-in-difference method were used to examine the effects of retailer disclosures. When controlling for factors previously determined to impact recall effectiveness, including product type, reasons for recall, the amount of food recalled, plant size, and the way the problem was discovered, no significant impact on recall effectiveness was discerned under the current disclosure policy. Recalls for bacterial contamination had higher recovery rates. Larger recalls had lower recovery rates and longer completion times. Recalls issued by very small plants had lower recovery rates. Compared with other stakeholders, government agency discovery of the problem was associated with lower recovery rates. As the U.S. Food and Drug Administration considers a similar retailer disclosure policy for foods regulated under the Food Safety Modernization Act, such lessons from the USDA experience should inform the policy debate.


Asunto(s)
Revelación , Aves de Corral , Animales , Contaminación de Alimentos/análisis , Inocuidad de los Alimentos , Carne , Productos Avícolas , Estados Unidos
17.
Pain Physician ; 23(4): E343-E352, 2020 07.
Artículo en Inglés | MEDLINE | ID: mdl-32709180

RESUMEN

BACKGROUND: The BenchMarket Medical (BMM) Vertebral Compression Fracture (VCF) Registry, now known as Talosix, is a collaborative effort between Talosix (the authorized registry vendor), Noridian Healthcare Solutions, and clinicians to gather outcomes evidence for cement augmentation treatments in patients with acute painful osteoporotic VCFs. The VCF Registry was designed to provide outcomes evidence to inform the Medicare payer's "coverage with evidence development" decision to authorize reimbursement for cement augmentation treatments. OBJECTIVES: The purpose of this article was to present a pathway for appropriate use of vertebral augmentation based on the findings of the VCF Registry. STUDY DESIGN: Prospective observational data, including patient characteristics, diagnosis, process of care, and patient-reported outcomes (PROs) for pain and function, were collected from patients undergoing cement augmentation treatment. The PROs were collected at baseline, 1, 3, and 6 months following the procedure. SETTING: The VCF Registry is a national ongoing registry with no specified end time or designated sample size. METHODS: Primary outcomes were pain improvement measured using the Numeric Rating Scale and function improvement, measured using the Roland Morris Disability Questionnaire (RMDQ). Secondary outcomes included cement leakage, new neurologic deficits, adverse events, readmissions, and death. RESULTS: The VCF Registry delivered outcomes data to support Noridian's "coverage with evidence development" decision. A total of 732 patients were included in this study. Registry outcomes confirmed postmarket evidence of highly significant pain relief with mean pain score improvement of 6.5/10 points at 6 months. Function also improved significantly with mean RMDQ score change of 11.4/24 points 6 months after surgery. Results also showed the safety and reliability of cement augmentation. LIMITATIONS: The nature of the registry data is that it contains nonrandomized, nonplacebo controlled data and should not be perceived as such. The real-world setting and the large number of patients within the dataset should increase the external validity of the findings. CONCLUSIONS: Cement augmentation treatments of patients with acute painful VCFs reliably results in highly significant benefits of pain decrease and functional improvement for this Medicare population. KEY WORDS: Vertebral compression fractures, osteoporosis, kyphoplasty, back pain, registry.


Asunto(s)
Cementos para Huesos , Fracturas por Compresión/cirugía , Cifoplastia/normas , Sistema de Registros , Fracturas de la Columna Vertebral/cirugía , Vertebroplastia/normas , Anciano , Anciano de 80 o más Años , Cementos para Huesos/uso terapéutico , Manejo de la Enfermedad , Femenino , Fracturas por Compresión/diagnóstico , Fracturas por Compresión/epidemiología , Humanos , Cifoplastia/métodos , Masculino , Persona de Mediana Edad , Osteoporosis/diagnóstico , Osteoporosis/epidemiología , Osteoporosis/cirugía , Manejo del Dolor/métodos , Manejo del Dolor/normas , Dimensión del Dolor/métodos , Dimensión del Dolor/normas , Estudios Prospectivos , Reproducibilidad de los Resultados , Fracturas de la Columna Vertebral/diagnóstico , Fracturas de la Columna Vertebral/epidemiología , Resultado del Tratamiento , Estados Unidos/epidemiología , Vertebroplastia/métodos
18.
Cell Rep ; 31(6): 107622, 2020 05 12.
Artículo en Inglés | MEDLINE | ID: mdl-32402283

RESUMEN

To date, no stem cell therapy has been directed to specific recipients-and, conversely, withheld from others-based on a clinical or molecular profile congruent with that cell's therapeutic mechanism-of-action (MOA) for that condition. We address this challenge preclinically with a prototypical scenario: human neural stem cells (hNSCs) against perinatal/neonatal cerebral hypoxic-ischemic injury (HII). We demonstrate that a clinically translatable magnetic resonance imaging (MRI) algorithm, hierarchical region splitting, provides a rigorous, expeditious, prospective, noninvasive "biomarker" for identifying subjects with lesions bearing a molecular profile indicative of responsiveness to hNSCs' neuroprotective MOA. Implanted hNSCs improve lesional, motor, and/or cognitive outcomes only when there is an MRI-measurable penumbra that can be forestalled from evolving into necrotic core; the core never improves. Unlike the core, a penumbra is characterized by a molecular profile associated with salvageability. Hence, only lesions characterized by penumbral > core volumes should be treated with cells, making such measurements arguably a regenerative medicine selection biomarker.


Asunto(s)
Biomarcadores/metabolismo , Lesiones Encefálicas/terapia , Medicina Regenerativa/métodos , Trasplante de Células Madre/métodos , Animales , Modelos Animales de Enfermedad , Ratas , Ratas Sprague-Dawley
19.
J Neurooncol ; 148(1): 141-154, 2020 May.
Artículo en Inglés | MEDLINE | ID: mdl-32346836

RESUMEN

PURPOSE: Unplanned readmission of post-operative brain tumor patients is often attributed to hospital and patient characteristics and is associated with higher mortality and cost. Previous studies demonstrate multiple patient outcome disparities in safety net hospitals (SNHs) when compared to non-SNHs. This study uses the Nationwide Readmissions Database (NRD) to determine if initial brain tumor resection at SNHs is associated with increased 30-day non-elective readmission rates. METHODS: Patients with benign or malignant primary or metastatic brain tumor undergoing craniotomy for surgical resection were retrospectively identified in the NRD from 2010 to 2014. SNHs were defined as hospitals with Medicaid and uninsured patient burden in the top quartile. Descriptive and multivariate analyses employing survey-adjusted logistic regression evaluated patient and hospital level factors influencing 30-day readmissions. RESULTS: During the study period, 83,367 patients met inclusion criteria. 44.7% of patients had a benign tumor, and 55.3% had a malignant tumor. Secondary CNS neoplasm (5.99%), post-operative infection (5.96%), and septicemia (4.26%) caused most readmissions within 30 days. Patients had increased unplanned readmission rates if they underwent craniotomy for tumor resection at a SNH in a small metropolitan area (OR 1.11, 95% CI 1.02-1.21, p = 0.01), but not at a SNH in a large metropolitan area (OR 0.99, 95% CI 0.93-1.05, p = 0.73). CONCLUSION: This finding may reflect differences in access to care and disparities in neurosurgical resources between small and large metropolitan areas. Inequities in expertise and capacity are relevant as surgical volume was also related to readmission rates. Further studies may be warranted to address such disparities.


Asunto(s)
Neoplasias Encefálicas/cirugía , Craneotomía/efectos adversos , Readmisión del Paciente/estadística & datos numéricos , Complicaciones Posoperatorias/epidemiología , Proveedores de Redes de Seguridad/estadística & datos numéricos , Adolescente , Adulto , Anciano , Neoplasias Encefálicas/complicaciones , Bases de Datos Factuales , Femenino , Humanos , Masculino , Persona de Mediana Edad , Adulto Joven
20.
J Cataract Refract Surg ; 46(1): 163-164, 2020 01.
Artículo en Inglés | MEDLINE | ID: mdl-32050250
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