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OBJECTIVE: To determine the frequency of physical therapy (PT) services and potential disparities in receiving PT among Medicare fee-for-service beneficiaries with a history of spine pain who live in long-term care (LTC) settings. DESIGN: Secondary cross-sectional analysis of Medicare administrative data on beneficiaries with a history of spine pain from 2017-2019. We identified LTC residents using a validated algorithm, then identified and described PT episodes that occurred after the LTC index date. To identify potential disparities in access to PT services, we performed multivariable logistic regression to determine resident demographic, clinical, and community factors associated with receiving PT. SETTING: Not applicable. PARTICIPANTS: Medicare fee-for-service LTC residents aged ≥65 years. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Receiving PT services. RESULTS: Of the 999,495 LTC residents with a history of spine pain, 49.6% received PT. Only 12.1% of PT episodes specifically treated spine pain. The odds of receiving PT were higher for residents with pain in multiple spine regions or neuropathic pain (OR, 1.27; 95% confidence interval CI, 1.26-1.29) and for residents with inpatient admissions (OR, 1.76; 95% CI, 1.75-1.78). Odds of receiving PT were lower for residents from minoritized racial and ethnic groups, and for residents with dementia (OR, 0.89; 95% CI, 0.88-0.90), depression (OR, 0.95; 95% CI, 0.94-0.96), or who lived in urban or more socioeconomically deprived areas. CONCLUSIONS: Although nearly half of LTC residents with histories of spine pain received PT services, most PT was not for spine pain. There are potential disparities in access to PT for LTC residents from minoritized groups living in urban and more deprived areas. Further work should examine PT outcomes and remove barriers to PT for LTC residents with histories of spine pain.
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OBJECTIVES: To compare 12-month spinal fusion surgery rates in the setting of low back pain among digital musculoskeletal (MSK) program participants versus a comparison cohort who only received usual care. STUDY DESIGN: Retrospective cohort study with propensity score matched comparison cohort using commercial medical claims data representing over 100 million commercially insured lives. METHODS: All study subjects experienced low back pain between January 2020 and December 2021. Digital MSK participants enrolled in the digital MSK low back program between January 2020 and December 2021. Non-participants had low back pain related physical therapy (PT) between January 2020 and December 2021. Digital MSK participants were matched to non-participants with similar demographics, comorbidities and baseline MSK-related medical care use. Spinal fusion surgery rates at 12 months post participation were compared. RESULTS: Compared to non-participants, digital MSK participants had lower rates of spinal fusion surgery in the post-period (0.7% versus 1.6%; p < 0.001). Additionally, in the augmented inverse probability weighting (AIPW) model, digital MSK participants were found to have decreased odds of undergoing spinal fusion surgery (adjusted odds ratio: 0.64, 95% CI: 0.51-0.81). CONCLUSIONS: This study provides evidence that participation in a digital MSK program is associated with a lower rate of spinal fusion surgery.
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Dor Lombar , Fusão Vertebral , Humanos , Fusão Vertebral/estatística & dados numéricos , Fusão Vertebral/tendências , Fusão Vertebral/efeitos adversos , Masculino , Feminino , Dor Lombar/cirurgia , Dor Lombar/epidemiologia , Dor Lombar/diagnóstico , Estudos Retrospectivos , Adulto , Pessoa de Meia-Idade , Pontuação de Propensão , Resultado do Tratamento , Modalidades de Fisioterapia/estatística & dados numéricos , Modalidades de Fisioterapia/tendênciasRESUMO
We evaluated whether older adults who received kyphoplasty had reduced risk of mortality compared to those who did not. In unmatched analyses, those receiving kyphoplasty were at reduced risk of death but after matching on age and medical complications, patients who received kyphoplasty were at increased risk of death. PURPOSE: In previous observational studies, kyphoplasty for treatment of osteoporotic vertebral fractures has been associated with decreased mortality compared to conservative management. The purpose of this research was to determine whether older adults who received kyphoplasty had reduced risk of mortality compared to matched patients who did not. METHODS: Retrospective cohort study of US Medicare enrollees with osteoporotic vertebral fractures between 2017-2019 comparing patients who underwent kyphoplasty to those who did not. We identified 2 control groups a priori: 1) non-augmented patients who met inclusion criteria (group 1); 2) propensity-matched patients on demographic and clinical variables (group 2). We then identified additional control groups using matching for medical complications (group 3) and age + comorbidities (group 4). We calculated hazard ratios (HRs) and 95% confidence intervals (95% CIs) associated with mortality. RESULTS: A total of 235,317 patients (mean (± standard deviation) age 81.1 ± 8.3 years; 85.8% female) were analyzed. In the primary analyses, those who received kyphoplasty were at reduced risk of death compared to those who did not: adjusted HR (95% CI) in group 1 = 0.84 (0.82, 0.87); and in group 2 = 0.88 (0.85, 0.91). However, in post hoc analyses, patients who received kyphoplasty were at increased risk of death: adjusted HR (95% CI) in group 3 = 1.32 (1.25, 1.41) and 1.81 (1.58, 2.09) in group 4. CONCLUSION: An apparent benefit of kyphoplasty on mortality among patients with vertebral fractures was not present after rigorous propensity matching, illustrating the importance of comparing similar individuals when evaluating observational data.
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Fraturas por Compressão , Cifoplastia , Fraturas por Osteoporose , Fraturas da Coluna Vertebral , Humanos , Feminino , Idoso , Estados Unidos/epidemiologia , Idoso de 80 Anos ou mais , Masculino , Fraturas da Coluna Vertebral/etiologia , Estudos Retrospectivos , Fraturas por Compressão/etiologia , Medicare , Coluna Vertebral , Fraturas por Osteoporose/etiologia , Resultado do TratamentoRESUMO
BACKGROUND: Low back pain (LBP) is a common condition made up of a variety of anatomic and clinical subtypes. Lumbar disc herniation (LDH) and lumbar spinal stenosis (LSS) are two subtypes highly associated with LBP. Patients with LDH/LSS are often started with non-surgical treatments and if those are not effective then go on to have decompression surgery. However, recommendation of surgery is complicated as the outcome may depend on the patient's health characteristics. We developed a deep learning (DL) model to predict decompression surgery for patients with LDH/LSS. MATERIALS AND METHOD: We used datasets of 8387 and 8620 patients from a prospective study that collected data from four healthcare systems to predict early (within 2 months) and late surgery (within 12 months after a 2 month gap), respectively. We developed a DL model to use patients' demographics, diagnosis and procedure codes, drug names, and diagnostic imaging reports to predict surgery. For each prediction task, we evaluated the model's performance using classical and generalizability evaluation. For classical evaluation, we split the data into training (80%) and testing (20%). For generalizability evaluation, we split the data based on the healthcare system. We used the area under the curve (AUC) to assess performance for each evaluation. We compared results to a benchmark model (i.e. LASSO logistic regression). RESULTS: For classical performance, the DL model outperformed the benchmark model for early surgery with an AUC of 0.725 compared to 0.597. For late surgery, the DL model outperformed the benchmark model with an AUC of 0.655 compared to 0.635. For generalizability performance, the DL model outperformed the benchmark model for early surgery. For late surgery, the benchmark model outperformed the DL model. CONCLUSIONS: For early surgery, the DL model was preferred for classical and generalizability evaluation. However, for late surgery, the benchmark and DL model had comparable performance. Depending on the prediction task, the balance of performance may shift between DL and a conventional ML method. As a result, thorough assessment is needed to quantify the value of DL, a relatively computationally expensive, time-consuming and less interpretable method.
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Aprendizado Profundo , Deslocamento do Disco Intervertebral , Dor Lombar , Estenose Espinal , Humanos , Descompressão Cirúrgica/efeitos adversos , Descompressão Cirúrgica/métodos , Estudos Prospectivos , Vértebras Lombares/cirurgia , Dor Lombar/diagnóstico , Dor Lombar/cirurgia , Dor Lombar/complicações , Deslocamento do Disco Intervertebral/cirurgia , Estenose Espinal/cirurgia , Resultado do Tratamento , Estudos RetrospectivosRESUMO
INTRODUCTION: Older adults with cognitive impairment, including those with Alzheimer's disease and related dementias, are particularly at risk for hospitalization and hospital-associated disability. Understanding of key risk factors for hospital-associated disability is limited. Sarcopenia, age-related declines in muscle mass and strength, is common in older adults with cognitive impairment and may be an important risk factor for hospital-associated disability. METHODS: Using data from the Health ABC Study, we examined associations of pre-hospitalization appendicular lean mass (ALM) and grip strength with the development of a new activity of daily living (ADL) disability at the next annual assessment after hospitalization. RESULTS: Grip strength, but not ALM, was negatively associated with increased risk of hospital-associated ADL disability, and this association was greater among those with cognitive impairment compared to those without. DISCUSSION: Lower grip strength may be an important risk factor for hospital-associated ADL disability in older adults, particularly those with cognitive impairment.
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Pessoas com Deficiência , Sarcopenia , Humanos , Idoso , Força da Mão/fisiologia , Sarcopenia/complicações , Hospitalização , HospitaisRESUMO
BACKGROUND: Information on the prevalence of common imaging findings among patients without back pain in spine imaging reports might affect pain medication prescribing for patients with back pain. Prior research on inserting this text suggested a small reduction in opioid prescribing. OBJECTIVE: To evaluate the effect of epidemiologic information in spine imaging reports on non-opioid pain medication prescribing for primary care patients with back pain. DESIGN: Post hoc analysis of the Lumbar Imaging with Reporting of Epidemiology cluster-randomized trial. PARTICIPANTS: A total of 170,680 patients aged ≥ 18 years from four healthcare systems who received thoracolumbar, lumbar, or lumbosacral spine imaging from 2013 to 2016 and had not received a prescription for non-opioid pain medication in the preceding 120 days. INTERVENTION: Text of age- and modality-specific epidemiologic benchmarks indicating the prevalence of common findings in people without back pain inserted into thoracolumbar, lumbar, or lumbosacral spine imaging reports at intervention clinics. MAIN MEASURES: Primary outcomes: any non-opioid prescription within 90 days after index imaging, overall, and by sub-class (skeletal muscle relaxants, NSAIDs, gabapentinoids, tricyclic antidepressants, benzodiazepines, duloxetine). SECONDARY OUTCOMES: count of non-opioid prescriptions within 90 days, overall, and by sub-class. KEY RESULTS: The intervention was not associated with the likelihood of patients receiving at least one prescription for new non-opioid pain-related medications, overall (adjusted OR, 1.02; 95% CI, 0.97-1.08) or by sub-class. The intervention was not associated with the number of prescriptions for any non-opioid medication (adjusted incidence rate ratio [IRR], 1.02; 95% CI, 0.99-1.04). However, the intervention was associated with more new prescriptions for NSAIDs (IRR, 1.12) and tricyclic antidepressants (IRR, 1.11). CONCLUSIONS: Inserting epidemiologic text in spine imaging reports had no effect on whether new non-opioid pain-related medications were prescribed but was associated with the number of new prescriptions for certain non-opioid sub-classes. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02015455.
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Analgésicos Opioides , Padrões de Prática Médica , Analgésicos Opioides/uso terapêutico , Dor nas Costas/diagnóstico por imagem , Dor nas Costas/tratamento farmacológico , Dor nas Costas/epidemiologia , Prescrições de Medicamentos , Humanos , Vértebras LombaresRESUMO
OBJECTIVE: To evaluate the effect of inserting epidemiological information into lumbar spine imaging reports on subsequent nonsurgical and surgical procedures involving the thoracolumbosacral spine and sacroiliac joints. DESIGN: Analysis of secondary outcomes from the Lumbar Imaging with Reporting of Epidemiology (LIRE) pragmatic stepped-wedge randomized trial. SETTING: Primary care clinics within four integrated health care systems in the United States. SUBJECTS: 238,886 patients ≥18 years of age who received lumbar diagnostic imaging between 2013 and 2016. METHODS: Clinics were randomized to receive text containing age- and modality-specific epidemiological benchmarks indicating the prevalence of common spine imaging findings in people without low back pain, inserted into lumbar spine imaging reports (the "LIRE intervention"). The study outcomes were receiving 1) any nonsurgical lumbosacral or sacroiliac spine procedure (lumbosacral epidural steroid injection, facet joint injection, or facet joint radiofrequency ablation; or sacroiliac joint injection) or 2) any surgical procedure involving the lumbar, sacral, or thoracic spine (decompression surgery or spinal fusion or other spine surgery). RESULTS: The LIRE intervention was not significantly associated with subsequent utilization of nonsurgical lumbosacral or sacroiliac spine procedures (odds ratio [OR] = 1.01, 95% confidence interval [CI] 0.93-1.09; P = 0.79) or any surgical procedure (OR = 0.99, 95 CI 0.91-1.07; P = 0.74) involving the lumbar, sacral, or thoracic spine. The intervention was also not significantly associated with any individual spine procedure. CONCLUSIONS: Inserting epidemiological text into spine imaging reports had no effect on nonsurgical or surgical procedure utilization among patients receiving lumbar diagnostic imaging.
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Dor Lombar , Doenças da Coluna Vertebral , Articulação Zigapofisária , Humanos , Dor Lombar/diagnóstico por imagem , Dor Lombar/epidemiologia , Vértebras Lombares/diagnóstico por imagem , Vértebras Lombares/cirurgia , Região Lombossacral , Doenças da Coluna Vertebral/diagnóstico por imagem , Doenças da Coluna Vertebral/epidemiologia , Doenças da Coluna Vertebral/cirurgia , Estados UnidosRESUMO
PURPOSE: To compare relative cost-effectiveness of serial large-volume paracentesis (LVP) and transjugular intrahepatic portosystemic shunt (TIPS) creation for treatment of refractory ascites. MATERIALS AND METHODS: A decisional Markov model was developed to estimate payer cost and quality-adjusted life-ears (QALYs) associated with LVP and TIPS treatment strategies for cirrhotic patients with refractory ascites. Survival estimates were derived from an individual patient-level meta-analysis of prospective randomized clinical trials. Health utilities for potential health states were derived from a prospective study of patients with cirrhosis. Cost data were derived from national representative claims databases (MarketScan and Medicare) and included reimbursement amounts for relevant procedures, hospitalizations, and outpatient pharmaceutical costs. One-way and probabilistic sensitivity analyses were performed. RESULTS: LVP resulted in 1.72 QALYs gained at a cost of $41,391, whereas TIPS resulted in 2.76 QALYs gained at a cost of $100,538. Incremental cost-effectiveness ratio of TIPS versus LVP was $57,003/QALY. At a willingness-to-pay ratio of $100,000/QALY, TIPS has a 62% probability of being acceptable compared with LVP. CONCLUSIONS: This study suggests that TIPS should be considered cost-effective in a country that places a relatively high value on health improvements but less so in countries with lower levels of health care resources.
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Ascite/cirurgia , Custos de Cuidados de Saúde , Cirrose Hepática/complicações , Modelos Econômicos , Paracentese/economia , Derivação Portossistêmica Transjugular Intra-Hepática/economia , Assistência Ambulatorial/economia , Ascite/diagnóstico , Ascite/etiologia , Ascite/mortalidade , Tomada de Decisão Clínica , Análise Custo-Benefício , Técnicas de Apoio para a Decisão , Custos de Medicamentos , Custos Hospitalares , Humanos , Cirrose Hepática/diagnóstico , Cirrose Hepática/economia , Cirrose Hepática/mortalidade , Cadeias de Markov , Paracentese/efeitos adversos , Paracentese/mortalidade , Derivação Portossistêmica Transjugular Intra-Hepática/efeitos adversos , Derivação Portossistêmica Transjugular Intra-Hepática/mortalidade , Anos de Vida Ajustados por Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto , Resultado do Tratamento , Estados UnidosRESUMO
OBJECTIVE: The purpose of this study was to compare the clinical effectiveness of embolization with that of sorafenib in the management of hepatocellular carcinoma as practiced in real-world settings. MATERIALS AND METHODS: This population-based observational study was conducted with the Surveillance, Epidemiology, and End Results-Medicare linked database. Patients 65 years old and older with a diagnosis of primary liver cancer between 2007 and 2011 who underwent embolization or sorafenib treatment were identified. Patients were excluded if they had insufficient claims records, a diagnosis of intrahepatic cholangiocarcinoma, or other primary cancer or had undergone liver transplant or combination therapy. The primary outcome of interest was overall survival. Inverse probability of treatment weighting models were used to control for selection bias. RESULTS: The inclusion and exclusion criteria were met by 1017 patients. Models showed good balance between treatment groups. Compared with those who underwent embolization, patients treated with sorafenib had significantly higher hazard of earlier death from time of treatment (hazard ratio, 1.87; 95% CI, 1.46-2.37; p < 0.0001) and from time of cancer diagnosis (hazard ratio, 1.87; 95% CI, 1.46-2.39; p < 0.0001). The survival advantage after embolization was seen in both intermediate- and advanced-stage disease. CONCLUSION: This comparative effectiveness study of Medicare patients with hepatocellular carcinoma showed significantly longer overall survival after treatment with embolization than with sorafenib. Because these findings conflict with expert opinion-based guidelines for treatment of advanced-stage disease, prospective randomized comparative trials in this subpopulation would be justified.
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Antineoplásicos/uso terapêutico , Carcinoma Hepatocelular/terapia , Embolização Terapêutica/métodos , Neoplasias Hepáticas/terapia , Sorafenibe/uso terapêutico , Idoso , Idoso de 80 Anos ou mais , Carcinoma Hepatocelular/mortalidade , Pesquisa Comparativa da Efetividade , Feminino , Humanos , Neoplasias Hepáticas/mortalidade , Masculino , Medicare , Programa de SEER , Taxa de Sobrevida , Resultado do Tratamento , Estados UnidosRESUMO
OBJECTIVE: To examine if a comorbid diagnosis of knee or hip osteoarthritis (OA) in older adults with new back pain visits is associated with long-term patient-reported outcomes and back-related health care use. DESIGN: Prospective cohort study. SETTING: Three integrated health systems forming the Back pain Outcomes using Longitudinal Data cohort. PARTICIPANTS: Participants (N=5155) were older adults (≥65y) with a new visit for back pain and a complete electronic health record data. INTERVENTIONS: Not applicable; we obtained OA diagnoses using diagnostic codes in the electronic health record 12 months prior to the new back pain visit. MAIN OUTCOME MEASURES: The Roland-Morris Disability Questionnaire (RDQ) and the EuroQol-5D (EQ-5D) were key patient-reported outcomes. Health care use, measured by relative-value units (RVUs), was summed for the 12 months after the initial visit. We used linear mixed-effects models to model patient-reported outcomes. We also used generalized linear models to test the association between comorbid knee or hip OA and total back-related RVUs. RESULTS: Of the 5155 participants, 368 (7.1%) had a comorbid knee OA diagnosis, and 94 (1.8%) had a hip OA diagnosis. Of the participants, 4711 (91.4%) had neither knee nor hip OA. In adjusted models, the 12-month RDQ score was 1.23 points higher (95% confidence interval [CI], 0.72-1.74) for patients with knee OA and 1.26 points higher (95% CI, 0.24-2.27) for those with hip OA than those without knee or hip OA, respectively. A lower EQ-5D score was found among participants with knee OA (.02 lower; 95% CI, -.04 to -.01) and hip OA diagnoses (.03 lower; 95% CI, -.05 to -.01) compared with those without knee or hip OA, respectively. Comorbid knee or hip OA was not significantly associated with total 12-month back-related resource use. CONCLUSIONS: Comorbid knee or hip OA in older adults with a new back pain visit was associated with modestly worse long-term disability and health-related quality of life.
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Dor nas Costas/epidemiologia , Dor nas Costas/terapia , Serviços de Saúde/estatística & dados numéricos , Osteoartrite do Quadril/epidemiologia , Osteoartrite do Joelho/epidemiologia , Idoso , Idoso de 80 Anos ou mais , Comorbidade , Avaliação da Deficiência , Feminino , Humanos , Estudos Longitudinais , Masculino , Visita a Consultório Médico/estatística & dados numéricos , Osteoartrite do Quadril/diagnóstico , Osteoartrite do Joelho/diagnóstico , Medidas de Resultados Relatados pelo Paciente , Estudos Prospectivos , Qualidade de Vida , Inquéritos e QuestionáriosRESUMO
IMPORTANCE: In contrast to the recommendations for younger adults, many guidelines allow for older adults with back pain to undergo imaging without waiting 4 to 6 weeks. However, early imaging may precipitate interventions that do not improve outcomes. OBJECTIVE: To compare function and pain at the 12-month follow-up visit among older adults who received early imaging with those who did not receive early imaging after a new primary care visit for back pain without radiculopathy. DESIGN, SETTING, AND PARTICIPANTS: Prospective cohort of 5239 patients 65 years or older with a new primary care visit for back pain (2011-2013) in 3 US health care systems. We matched controls 1:1 using propensity score matching of demographic and clinical characteristics, including diagnosis, pain severity, pain duration, functional status, and prior resource use. EXPOSURES: Diagnostic imaging (plain films, computed tomography [CT], magnetic resonance imaging [MRI]) of the lumbar or thoracic spine within 6 weeks of the index visit. PRIMARY OUTCOME: back or leg pain-related disability measured by the modified Roland-Morris Disability Questionnaire (score range, 0-24; higher scores indicate greater disability) 12 months after enrollment. RESULTS: Among the 5239 patients, 1174 had early radiographs and 349 had early MRI/CT. At 12 months, neither the early radiograph group nor the early MRI/CT group differed significantly from controls on the disability questionnaire. The mean score for patients who underwent early radiography was 8.54 vs 8.74 among the control group (difference, -0.10 [95% CI, -0.71 to 0.50]; mixed model, P = .36). The mean score for the early MRI/CT group was 9.81 vs 10.50 for the control group (difference,-0.51 [-1.62 to 0.60]; mixed model, P = .18). CONCLUSIONS AND RELEVANCE: Among older adults with a new primary care visit for back pain, early imaging was not associated with better 1-year outcomes. The value of early diagnostic imaging in older adults for back pain without radiculopathy is uncertain.
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Dor nas Costas/diagnóstico , Diagnóstico Precoce , Idoso , Dor nas Costas/diagnóstico por imagem , Custos e Análise de Custo , Feminino , Humanos , Achados Incidentais , Imageamento por Ressonância Magnética , Masculino , Medição da Dor , Pontuação de Propensão , Estudos Prospectivos , Radiografia , UltrassonografiaRESUMO
OBJECTIVES: To compare 12-month total knee arthroplasty (TKA) and total hip arthroplasty (THA) rates for digital musculoskeletal (MSK) program members vs patients who received traditional care for knee or hip osteoarthritis (OA). STUDY DESIGN: Retrospective, longitudinal study with propensity score-matched comparison group that used commercial medical claims data representing more than 100 million commercially insured lives. METHODS: Study participants with hip OA (M16.x) or knee OA (M17.x) International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) codes were identified in the medical claims database. Digital MSK program members were identified using record linkage tokens. The comparison group had hip- or knee-related physical therapy identified via ICD-10-CM and Current Procedural Terminology codes. Respectively in each knee and hip OA group, digital members were matched to control group patients with similar demographics, comorbidities, and baseline MSK-related medical care use. TKA and THA at 12 months post participation were compared. RESULTS: In the knee OA group, 739 of 56,634 control group patients were matched to 739 digital members. At 12 months, 3.79% of digital members and 14.21% of control group patients had TKA (difference, 10.42%; P < .001). In the hip OA group, 141 of 20,819 control group patients were matched to 141 digital members. At 12 months, 16.31% of digital members and 32.62% of control group patients had THA (difference, 16.31%; P = .001). CONCLUSIONS: These findings suggest that patients who participated in a digital MSK program to manage OA have lower rates of total joint arthroplasty in the 12 months after enrollment.
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Artroplastia de Quadril , Artroplastia do Joelho , Osteoartrite do Quadril , Osteoartrite do Joelho , Humanos , Osteoartrite do Quadril/cirurgia , Estudos Retrospectivos , Estudos Longitudinais , Osteoartrite do Joelho/cirurgiaRESUMO
BACKGROUND: Dornase alfa and hypertonic saline are mucoactive therapies that can improve respiratory symptoms in people with cystic fibrosis (CF). A recent randomized control trial showed that participants with well-preserved pulmonary function taking elexacaftor + tezacaftor + ivacaftor (ETI) who discontinued dornase alfa or hypertonic saline for 6 weeks had no clinically meaningful decline in lung function. This may prompt discussions with care providers regarding ongoing use of these medications. OBJECTIVE: To compare the costs of outpatient medications between people taking ETI who continued or discontinued (1) dornase alfa or (2) hypertonic saline from 2 clinical trials and project cost differences in the US CF population if these 2 medications were used only intermittently for symptom relief instead of chronically. METHODS: The SIMPLIFY study was 2 parallel multicenter trials that randomized participants 1:1 to either continue or discontinue therapy. To estimate costs, we used data from the Merative MarketScan Databases to identify people with CF from 2020 to 2021. Our primary outcomes were differences in costs of outpatient prescription drugs among those who continued vs discontinued dornase alfa and, separately, hypertonic saline. We obtained adjusted differences in median costs. To estimate the annual cost savings if the population of people with CF taking ETI used these medications only intermittently, we multiplied the proportion of people in MarketScan with CF diagnoses who were taking each of these medications by the median cost savings per year and subtracted the cost of "rescue" use. RESULTS: A total of 392 participants from the dornase alfa trial and 273 from the hypertonic saline trial were included in analyses. The adjusted difference in median medication costs was not significant for the hypertonic saline trial, but we observed a significantly decreased 6-week cost of medications in the dornase alfa trial (adjusted median difference in costs between discontinue and continue of $5,860 (95% CI = $4,870-$6,850); P < 0.0001). We estimated that two-thirds of people with CF use ETI and dornase alfa in the United States; if they discontinued dornase alfa except for intermittent use, the resulting annual savings would be $1.21 billion. CONCLUSIONS: Although the costs of dornase alfa and hypertonic saline are smaller compared with ETI, reduction in use would lead to substantial prescription drug cost savings and reduce the treatment burden. However, individual benefits of these therapies should be considered, and decisions regarding changes in therapy remain an important discussion between people with CF and their providers. Study registration number: NCT04378153.
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Fibrose Cística , Medicamentos sob Prescrição , Humanos , Fibrose Cística/tratamento farmacológico , Administração por Inalação , Medicamentos sob Prescrição/uso terapêutico , Coleta de Dados , Bases de Dados Factuais , Proteínas RecombinantesRESUMO
OBJECTIVE: It remains unknown whether frailty status portends an increased risk of adverse outcomes in patients with rheumatoid arthritis (RA) initiating biologic or targeted-synthetic (b/ts) disease-modifying antirheumatic drugs (DMARDs). The objective of our study was to evaluate the association between frailty and serious infections in a younger population of patients (<65 years old) with RA who initiated b/tsDMARDs. METHODS: Using MarketScan data, we identified new users of tumor necrosis factor inhibitors (TNFi), non-TNFi biologic DMARDs, or Janus kinase inhibitors (JAKi) between 2008 and 2019 among those with RA. Patients' baseline frailty risk score was calculated using a Claims-Based Frailty Index (≥0.2 defined as frail) 12 months prior to drug initiation. The primary outcome was time to serious infection; secondarily, we examined time-to-any infection and all-cause hospitalizations. We used Cox proportional hazards to estimate adjusted hazard ratios and 95% confidence intervals (95% CIs) and assessed the significance of interaction terms between frailty status and drug class. RESULTS: A total of 57,980 patients, mean (±SD) age 48.1 ± 10.1 were included; 48,139 (83%) started TNFi, 8,111 (14%) non-TNFi biologics, and 1,730 (3%) JAKi. Among these, 3,560 (6%) were categorized as frail. Frailty was associated with a 50% increased risk of serious infections (adjusted hazard ratio [95% CI] 1.5, 1.2-1.9) and 40% higher risk of inpatient admissions (1.4 [1.3-1.6]) compared with nonfrail patients among those who initiated TNFi. Frailty was also associated with a higher risk of any infection relative to nonfrail patients among those on TNFi (1.2 [1.1-1.3]) or non-TNFi (1.2 [1.0-1.4]) or JAKi (1.4 [1.0-2.0]). CONCLUSION: Frailty is an important predictor for the risk of adverse outcomes among patients with RA treated with biologic or targeted-synthetic DMARDs.
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Antirreumáticos , Artrite Reumatoide , Fragilidade , Humanos , Artrite Reumatoide/tratamento farmacológico , Masculino , Feminino , Pessoa de Meia-Idade , Antirreumáticos/efeitos adversos , Antirreumáticos/uso terapêutico , Fragilidade/epidemiologia , Fragilidade/diagnóstico , Adulto , Produtos Biológicos/efeitos adversos , Produtos Biológicos/uso terapêutico , Fatores de Risco , Medição de Risco , Infecções/epidemiologia , Infecções/induzido quimicamente , Infecções/etiologia , Inibidores de Janus Quinases/efeitos adversos , Inibidores de Janus Quinases/uso terapêutico , Estudos Retrospectivos , Estados Unidos/epidemiologia , Resultado do Tratamento , Inibidores do Fator de Necrose Tumoral/efeitos adversos , Inibidores do Fator de Necrose Tumoral/uso terapêutico , Hospitalização , Fatores de Tempo , Bases de Dados FactuaisRESUMO
IMPORTANCE: Given the negative impact of opioid use on population health, prescriptions for alternative pain-relieving medications, including gabapentin, have increased. Concurrent gabapentin and opioid prescriptions are commonly reported in retrospective studies of opioid-related overdose deaths. OBJECTIVE: To determine whether people who filled gabapentin and opioid prescriptions concurrently ('gabapentin + opioids') had greater mortality than those who filled an active control medication (tricyclic antidepressants [TCAs] or duloxetine) and opioids concurrently ('TCAs/duloxetine + opioids'). We hypothesized that people treated with gabapentin + opioids would have higher mortality rates compared to people treated with TCAs/duloxetine + opioids. DESIGN: Propensity score-matched cohort study with an incident user, active control design. The median (maximum) follow-up was 45 (1093) days. SETTING: Population-based. PARTICIPANTS: Medicare beneficiaries with spine-related diagnoses 2017-2019. The primary analysis included those who concurrently (within 30 days) filled at least 1 incident gabapentin + at least 1 opioid or at least 1 incident TCA/duloxetine + at least 1 opioid. EXPOSURES: People treated with gabapentin + opioids (n=67,133) were matched on demographic and clinical factors in a 1:1 ratio to people treated with TCAs/duloxetine + opioids (n=67,133). MAIN OUTCOMES AND MEASURES: The primary outcome was mortality at any time. A secondary outcome was occurrence of a major medical complication at any time. RESULTS: Among 134,266 participants (median age 73.4 years; 66.7% female), 2360 died before the end of follow-up. No difference in mortality was observed between groups (adjusted hazard ratio (HR) and 95% confidence interval (CI) for gabapentin + opioids was 0.98 (0.90, 1.06); p=0.63). However, people treated with gabapentin + opioids were at slightly increased risk of a major medical complication (1.02 (1.00, 1.04); p=0.03) compared to those treated with TCAs/duloxetine + opioids. Results were similar in analyses (a) restricted to less than or = 30-day follow-up and (b) that required at least 2 fills of each prescription. CONCLUSIONS AND RELEVANCE: When treating pain in older adults taking opioids, the addition of gabapentin did not increase mortality risk relative to addition of TCAs or duloxetine. However, providers should be cognizant of a small increased risk of major medical complications among opioid users initiating gabapentin compared to those initiating TCAs or duloxetine.
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OBJECTIVE: Although interventions have been shown to alleviate symptoms in most patients suffering from asthma, only one-third of asthma patients have disease that is well-controlled. The purpose of this study is to investigate whether partly and uncontrolled asthmas are associated with increased costs for asthma-related healthcare utilization compared to well-controlled asthma and to determine whether these associations differed across racial groups. METHODS: We classified respondents from the Asthma Insights and Management survey into those with well-, partly and uncontrolled asthma and compared utilization of healthcare services and costs among these groups, as well as between whites and non-whites. RESULTS: Respondents categorized as having asthma that was not well-controlled reported lower income levels, higher rates of unemployment and more trouble paying for healthcare; similar results were found in analyses stratified by race. Patients whose asthma was partly or uncontrolled had greater use of asthma-related medications and medical services compared to patients whose asthma was well-controlled. Total unadjusted and adjusted costs were greater in patients whose asthma was classified as partly and uncontrolled. Similar results were found in analyses stratified on race. Across all levels of asthma control, non-whites had higher rates of utilization of emergency rooms and urgent care facilities and had greater rates of hospitalizations compared to whites. CONCLUSIONS: Our findings indicate that patients with asthma that is not well-controlled utilized more healthcare resources and had greater medical costs, despite lacking of health insurance which may suggest less access to care.
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Antiasmáticos/uso terapêutico , Asma/tratamento farmacológico , Asma/economia , Adolescente , Adulto , Antiasmáticos/economia , Asma/etnologia , População Negra , Distribuição de Qui-Quadrado , Criança , Estudos Transversais , Serviço Hospitalar de Emergência/economia , Feminino , Hispânico ou Latino , Humanos , Seguro Saúde/economia , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Fatores Socioeconômicos , Estados Unidos , População Branca , Adulto JovemRESUMO
Background: In-person, conservative care may decrease opioid use for chronic musculoskeletal (MSK) pain, but the impact of digitally delivered conservative care on opioid use is unknown. This study examines associations between a digital MSK program and opioid initiation and prescriptions among opioid naive adults with chronic MSK pain. Methods: This observational study used commercial medical and pharmacy claims data to compare digital MSK program members to matched physical therapy (PT) patients. Outcomes were any opioid prescriptions and opioid prescriptions per 100 participants within the 12-months after starting a digital MSK program. After propensity-score matching, we conducted multivariate regression models that controlled for demographic, comorbidity, and baseline MSK healthcare use. Results: The study included 4195 members and 4195 matched PT patients. For opioid initiation, 7.89% (95% Confidence Interval [CI]: 7.07%, 8.71%) of members had opioid prescriptions within 12 months after starting the digital MSK program versus 13.64% (95% CI: 12.60%, 14.67%) of matched PT patients (p < 0.001). Members had significantly fewer opioid prescriptions (16.73 per 100 participants; 95% CI: 14.11, 19.36) versus PT patients (22.36 per 100 participants; 95% CI: 19.99, 24.73). Members had lower odds (OR: 0.52, 95% CI: 0.45, 0.60) of initiating opioids and significantly fewer prescriptions per 100 participants (beta: -6.40, 95% CI: -9.88, -2.93) versus PT patients after controlling for available confounding factors. Conclusion: An MSK program that delivers conservative care digitally may be a promising approach for decreasing opioid initiation among individuals with chronic MSK pain given the limitations of the observational design and matching on only available covariates.
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OBJECTIVE: In this study of patients hospitalized during acute SARS-CoV2 infection with 6-months of follow-up data, we identified risk factors associated with the development of neuro-PASC. METHODS: We conducted an exploratory, observational single-center cohort study of patients hospitalized for COVID-19 from November 2020 to March 2022. Our primary outcome was persistent neurocognitive symptoms, defined as fatigue, headache, loss of taste/smell, brain fog, confusion, concentration/memory/word finding difficulty, and/or change in speech present at 1-month and persisting for 6-months following acute SARS-CoV2 infection. Secondary outcomes included persistent impairment scores on PROMIS cognitive function and abilities scales. Multivariate logistic regression analyses identified potential risk factors for neuro-PASC. RESULTS: Of 89 participants, 60% reported persistent neurocognitive symptoms at 6-months; fatigue was the most prevalent, occurring in 53% of participants, followed by brain fog in 34% of participants. Lower self-reported socioeconomic status and increased pre-COVID-19 anxiety scores on the Hospital Anxiety and Depression Scale were associated with increased odds of developing persistent neurocognitive symptoms. Being female and of Hispanic descent were associated with increased odds of persistent cognitive function and ability impairment. INTERPRETATION: Sociodemographic factors and pre-COVID-19 anxiety symptoms may be important risk factors for neuro-PASC. These findings underscore the need to assess various sociodemographic factors in research on PASC. Our study also highlights premorbid mental health symptoms as a potential predictor of persistent neurocognitive symptoms following hospitalization with SARS-CoV2 infection.
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COVID-19 , RNA Viral , Humanos , Feminino , Masculino , Estudos de Coortes , COVID-19/complicações , SARS-CoV-2 , Fatores de Risco , Hospitalização , Progressão da Doença , Fadiga/epidemiologia , Fadiga/etiologiaRESUMO
Previous studies indicate that hospital rather than home treatment of pulmonary exacerbations (PEx) in people with cystic fibrosis (CF) can improve outcomes. We evaluated characteristics of adult participants from the Standardized Treatment of Pulmonary Exacerbations (STOP2) trial with two separate comparisons: (1) those who were treated initially in hospital (N = 768) to those treated initially at home (N = 214) and (2) those treated only in hospital (N = 328) to those who were treated only at home or both at home and in hospital (N = 654). Participants who had Medicaid insurance, were treated for shorter duration, and traveled longer to reach treatment centers were more likely to have been treated initially in the hospital. Having Medicaid insurance, being treated for a shorter duration, and being male were associated with being treated only in the hospital. This analysis suggests decisions about the location of treatment are based on pragmatic factors rather than on clinical characteristics.
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STUDY DESIGN: Secondary analysis of a randomized controlled trial. OBJECTIVE: To assess how baseline treatment with opioids is associated with pain and function in older adults with lumbar spinal stenosis who receive epidural injections. SUMMARY OF BACKGROUND DATA: Data were obtained from the Lumbar Epidural Steroid injections for Spinal Stenosis trial, a double-blind, multisite, randomized controlled trial. METHODS: Baseline treatment with opioids was assessed from electronic medical record prescription pharmacy data or from health utilization records collected from patients. We calculated adjusted changes in back pain numerical rating scale, leg pain numerical rating scale, and back-related disability (Roland Morris Disability Questionnaire scores) from baseline to three weeks and to six weeks among patients treated and not treated with opioids at baseline using generalized linear regression. RESULTS: Baseline treatment with opioids was not significantly associated with back pain intensity (adjusted difference in means at three weeks of follow-up between patients treated with opioids at baseline versus not [±95% CI, 0.1 (-0.7, 0.7)], leg pain intensity [-0.2 (-0.9, 0.4)], or back-related function [-0.8 (-2.1, 0.4)]. We found similar results at six weeks of follow-up. CONCLUSIONS: Among older adults with lumbar spinal stenosis who are receiving epidural injections, those treated with opioids at baseline had similar outcomes to those who were not.