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Research articles in the clinical and translational science literature commonly use quantitative data to inform evaluation of interventions, learn about the etiology of disease, or develop methods for diagnostic testing or risk prediction of future events. The peer review process must evaluate the methodology used therein, including use of quantitative statistical methods. In this manuscript, we provide guidance for peer reviewers tasked with assessing quantitative methodology, intended to complement guidelines and recommendations that exist for manuscript authors. We describe components of clinical and translational science research manuscripts that require assessment including study design and hypothesis evaluation, sampling and data acquisition, interventions (for studies that include an intervention), measurement of data, statistical analysis methods, presentation of the study results, and interpretation of the study results. For each component, we describe what reviewers should look for and assess; how reviewers should provide helpful comments for fixable errors or omissions; and how reviewers should communicate uncorrectable and irreparable errors. We then discuss the critical concepts of transparency and acceptance/revision guidelines when communicating with responsible journal editors.
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CONTEXT: Emotion regulation by the physician can influence the effectiveness of serious illness conversations. The feasibility of multimodal assessment of emotion regulation during these conversations is unknown. OBJECTIVES: To develop and assess an experimental framework for evaluating physician emotion regulation during serious illness conversations. METHODS: We developed and then assessed a multimodal assessment framework for physician emotion regulation using a cross-sectional, pilot study on physicians trained in the Serious Illness Conversation Guide (SICG) in a simulated, telehealth encounter. Development of the assessment framework included a literature review and subject matter expert consultations. Our predefined feasibility endpoints included: an enrollment rate of ≥60% of approached physicians, >90% completion rate of survey items, and <20% missing data from wearable heart rate sensors. To describe physician emotion regulation, we performed a thematic analysis of the conversation, its documentation, and physician interviews. RESULTS: Out of 12 physicians approached, 11 (92%) SICG-trained physicians enrolled in the study: five medical oncology and six palliative care physicians. All 11 completed the survey (100% completion rate). Two sensors (chest band, wrist sensor) had <20% missing data during study tasks. The forearm sensor had >20% missing data. The thematic analysis found that physicians': 1) overarching goal was to move beyond prognosis to reasonable hope; 2) tactically focused on establishing a trusting, supportive relationship; and 3) possessed incomplete awareness of their emotion regulation strategies. CONCLUSION: Our novel, multimodal assessment of physician emotion regulation was feasible in a simulated SICG encounter. Physicians exhibited an incomplete understanding of their emotion regulation strategies.
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Regulação Emocional , Médicos , Humanos , Relações Médico-Paciente , Estudos Transversais , Projetos Piloto , Médicos/psicologia , ComunicaçãoRESUMO
Importance: Surveillance after prior colon polyps is the most frequent indication for colonoscopy in older adults. However, to our knowledge, the current use of surveillance colonoscopy, clinical outcomes, and follow-up recommendations in association with life expectancy, factoring in both age and comorbidities, have not been studied. Objective: To evaluate the association of estimated life expectancy with surveillance colonoscopy findings and follow-up recommendations among older adults. Design, Setting, and Participants: This registry-based cohort study used data from the New Hampshire Colonoscopy Registry (NHCR) linked with Medicare claims data and included adults in the NHCR who were older than 65 years, underwent colonoscopy for surveillance after prior polyps between April 1, 2009, and December 31, 2018, and had full Medicare Parts A and B coverage and no Medicare managed care plan enrollment in the year prior to colonoscopy. Data were analyzed from December 2019 to March 2021. Exposures: Life expectancy (<5 years, 5 to <10 years, or ≥10 years), estimated using a validated prediction model. Main Outcomes and Measures: The main outcomes were clinical findings of colon polyps or colorectal cancer (CRC) and recommendations for future colonoscopy. Results: Among 9831 adults included in the study, the mean (SD) age was 73.2 (5.0) years and 5285 (53.8%) were male. A total of 5649 patients (57.5%) had an estimated life expectancy of 10 or more years, 3443 (35.0%) of 5 to less than 10 years, and 739 (7.5%) of less than 5 years. Overall, 791 patients (8.0%) had advanced polyps (768 [7.8%]) or CRC (23 [0.2%]). Among the 5281 patients with available recommendations (53.7%), 4588 (86.9%) were recommended to return for future colonoscopy. Those with longer life expectancy or more advanced clinical findings were more likely to be told to return. For example, among patients with no polyps or only small hyperplastic polyps, 132 of 227 (58.1%) with life expectancy of less than 5 years were told to return for future surveillance colonoscopy vs 940 of 1257 (74.8%) with life expectancy of 5 to less than 10 years and 2163 of 2272 (95.2%) with life expectancy of 10 years or more (P < .001). Conclusions and Relevance: In this cohort study, the likelihood of finding advanced polyps and CRC on surveillance colonoscopy was low regardless of life expectancy. Despite this observation, 58.1% of older adults with less than 5 years' life expectancy were recommended to return for future surveillance colonoscopy. These data may help refine decision-making about pursuing or stopping surveillance colonoscopy in older adults with a history of polyps.
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Pólipos do Colo , Neoplasias Colorretais , Humanos , Masculino , Idoso , Feminino , Estudos de Coortes , Seguimentos , Colonoscopia , Expectativa de Vida , Neoplasias Colorretais/epidemiologiaRESUMO
PURPOSE: In the genomic era, more women with low-risk breast cancer will forego chemotherapy and rely on adjuvant endocrine therapy (AET) to prevent metastatic recurrence. However, some of these patients will unfortunately relapse. We sought to understand this outcome. Preliminary work suggested that early discontinuation of AET, also known as non-persistence, may play an important role. A retrospective analysis exploring factors related to our breast cancer patients' non-persistence with AET was performed. METHODS: Women who underwent Oncotype-DX® testing between 2011 and 2014 with minimum 5 years follow-up were included. 'Low risk' was defined as Oncotype score < 26. Outcomes of recurrence and persistence were determined by chart review. Patient, tumor and treatment factors were collected, and persistent versus non-persistent groups compared using multivariable ANOVA and Fisher Chi square exact test. RESULTS: We identified six cases of distant recurrence among low-risk patients with a median follow-up of 7.7 years. Among them, five of six patients (83%) were non-persistent with AET. The non-persistence rate in our cohort regardless of recurrence was 57/228 (25%). Non-persistent patients reported more severe side effects compared with persistent patients (p = 0.002) and were more likely to be offered a switch in endocrine therapy, rather than symptom-relief (p = 0.006). In contrast, persistent patients were 10.3 times more likely to have been offered symptom-alleviating medications compared with non-persistent patients (p < 0.001). A subset analysis revealed that patients who persisted with therapy had a higher Oncotype-DX® score than patients who discontinued early (p = 0.028). CONCLUSION: Metastatic recurrence in low-risk breast cancer patients may be primarily due to non-persistence with endocrine therapy. Further work is needed to optimize care for patients who struggle with side effects. To our knowledge, these are the first published data suggesting that Oncotype-DX® score may influence persistence with AET.
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Neoplasias da Mama , Humanos , Feminino , Neoplasias da Mama/patologia , Estudos Retrospectivos , Risco , Genômica , Recidiva Local de Neoplasia/epidemiologia , Recidiva Local de Neoplasia/prevenção & controle , Recidiva Local de Neoplasia/tratamento farmacológico , Quimioterapia AdjuvanteRESUMO
PURPOSE: Increased oxygen levels may enhance the radiosensitivity of brain metastases treated with stereotactic radiosurgery (SRS). This project administered hyperbaric oxygen (HBO) prior to SRS to assess feasibility, safety, and response. METHODS: 38 patients were studied, 19 with 25 brain metastases treated with HBO prior to SRS, and 19 historical controls with 27 metastases, matched for histology, GPA, resection status, and lesion size. Outcomes included time from HBO to SRS, quality-of-life (QOL) measures, local control, distant (brain) metastases, radionecrosis, and overall survival. RESULTS: The average time from HBO chamber to SRS beam-on was 8.3 ± 1.7 minutes. Solicited adverse events (AEs) were comparable between HBO and control patients; no grade III or IV serious AEs were observed. Radionecrosis-free survival (RNFS), radionecrosis-free survival before whole-brain radiation therapy (WBRT) (RNBWFS), local recurrence-free survival before WBRT (LRBWFS), distant recurrence-free survival before WBRT (DRBWFS), and overall survival (OS) were not significantly different for HBO patients and controls on Kaplan-Meier analysis, though at 1-year estimated survival rates trended in favor of SRS + HBO: RNFS - 83% vs 60%; RNBWFS - 78% vs 60%; LRBWFS - 95% vs 78%; DRBWFS - 61% vs 57%; and OS - 73% vs 56%. Multivariate Cox models indicated no significant association between HBO treatment and hazards of RN, local or distant recurrence, or mortality; however, these did show statistically significant associations (p < 0.05) for: local recurrence with higher volume, radionecrosis with tumor resection, overall survival with resection, and overall survival with higher GPA. CONCLUSION: Addition of HBO to SRS for brain metastases is feasible without evident decrement in radiation necrosis and other clinical outcomes.
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Neoplasias Encefálicas , Oxigenoterapia Hiperbárica , Lesões por Radiação , Radiocirurgia , Humanos , Radiocirurgia/efeitos adversos , Neoplasias Encefálicas/radioterapia , Neoplasias Encefálicas/secundário , Irradiação Craniana , Qualidade de Vida , Resultado do Tratamento , Estudos Retrospectivos , Lesões por Radiação/etiologia , OxigênioRESUMO
BACKGROUND: The COVID-19 pandemic necessitated a rapid shift to telemedicine to minimize patient and provider exposure risks. While telemedicine has been used in a variety of primary and specialty care settings for many years, it has been slow to be adopted in oncology care. Health care provider and administrator perspectives on factors affecting telemedicine use in oncology settings are not well understood, and the conditions associated with the COVID-19 pandemic offered the opportunity to study the adoption of telemedicine and the resulting provider and staff perspectives on its use. OBJECTIVE: The aim of this paper is to study the factors that influenced telemedicine uptake and sustained use in outpatient oncology clinics at a US cancer center to inform future telemedicine practices. METHODS: We used purposive sampling to recruit a mix of oncology specialty providers, practice managers, as well as nursing and administrative staff representing 5 outpatient oncology clinics affiliated with the Dartmouth Cancer Center, a large regional cancer center in the northeast of United States, to participate in semistructured interviews conducted over 6 weeks in spring 2021. The interview guide was informed by the 5 domains of the Consolidated Framework for Implementation Research, which include inner and outer setting factors, characteristics of the intervention (ie, telemedicine modality), individual-level factors (eg, provider and patient characteristics), and implementation processes. In total, 11 providers, 3 leaders, and 6 staff participated following verbal consent, and thematic saturation was reached across the full sample. We used a mixed deductive and inductive qualitative analysis approach to study the main influences on telemedicine uptake, implementation, and sustainability during the first year of the COVID-19 pandemic across the 5 settings. RESULTS: The predominant influencers of telemedicine adoption in this study were individual provider experiences and assumptions about patient preference and accessibility. Providers' early telemedicine experiences, especially if negative, influenced preferences for telephone over video and affected sustained use. Telemedicine was most favorably viewed for lower-acuity cancer care, visits less dependent on physical exam, and for patient and caregiver education. A lack of clinical champions, leadership guidance, and vision hindered the implementation of standardized practices and were cited as essential for telemedicine sustainability. Respondents expressed anxiety about sustaining telemedicine use if reimbursements for telephonic visits diminished or ceased. Opportunities to enhance future efforts include a need to provide additional guidance supporting telemedicine use cases and evidence of effectiveness in oncology care and to address provider concerns with communication quality. CONCLUSIONS: In a setting of decentralized care processes, early challenges in telemedicine implementation had an outsized impact on the nature and amount of sustained use. Proactively designed telemedicine care processes with attention to patient needs will be essential to support a sustained role for telemedicine in cancer care.
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PURPOSE: To characterize the use of telemedicine for oncology care over the course of the COVID-19 pandemic in Northern New England with a focus on factors affecting trends. METHODS: We performed a retrospective observational study using patient visit data from electronic health records from hematology-oncology and radiation-oncology service lines spanning the local onset of the pandemic from March 18, 2020, through March 31, 2021. This period was subdivided into four phases designated as lockdown, transition, stabilization, and second wave. Generalized linear mixed regression models were used to estimate the effects of patient characteristics on trends for rates of telemedicine use across phases and the effects of visit type on patient satisfaction and postvisit ER or hospital admissions within 2 weeks. RESULTS: A total of 19,280 patients with 102,349 visits (13.1% audio-only and 1.4% video) were studied. Patient age (increased use in age < 45 and 85 years and older) and urban residence were associated with higher use of telemedicine, especially after initial lockdown. Recent cancer therapy, ER use, and hospital admissions in the past year were all associated with lower telemedicine utilization across pandemic phases. Provider clinical department corresponded to the largest differences in telemedicine use across all phases. ER and hospital admission rates in the 2 weeks after a telehealth visit were lower than those in in-person visits (0.7% v 1.3% and 1.2% v 2.7% for ER and hospital use, respectively; P < .001). Patient satisfaction did not vary across visit types. CONCLUSION: Telemedicine use in oncology during the COVID-19 pandemic varied according to the phase and patient, medical, and health system factors, suggesting opportunities for standardization of care and need for attention to equitable telemedicine access.
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COVID-19 , Neoplasias , Telemedicina , Idoso , Idoso de 80 Anos ou mais , COVID-19/epidemiologia , Controle de Doenças Transmissíveis , Humanos , Pessoa de Meia-Idade , Neoplasias/epidemiologia , Neoplasias/terapia , Pandemias , Satisfação do PacienteRESUMO
BACKGROUND AND OBJECTIVES: We conducted a multisite, pragmatic replication trial at 4 New England epilepsy centers to determine the effectiveness of Home-Based Self-Management and Cognitive Training Changes Lives (HOBSCOTCH) in a real-world setting and to assess feasibility of a virtual intervention. METHODS: HOBSCOTCH is an 8-session intervention addressing cognitive impairment and quality of life (QoL) for people with epilepsy (PWE). Participants were recruited from epilepsy centers in 4 states and block-randomized into the following groups: in-person HOBSCOTCH (H-IP), virtual HOBSCOTCH (H-V), and waitlist control. Outcome measures were assessed for all groups at baseline, 3 months, and 6 months; intervention groups received long-term follow-up at 9 and 12 months. RESULTS: A total of 108 participants were recruited, of whom 85 were included in this analysis (age at baseline 47.5 ± 11.5 years; 68% female). Participants completing the in-person intervention (H-IP) had a 12.4-point improvement in QoL score compared with controls (p < 0.001). Pairwise comparisons found a 6.2-point treatment effect for subjective cognition in the H-IP group (p < 0.001). There were no meaningful group differences in objective cognition or health care utilization at any time points and the treatment effect for QoL diminished by 6 months. The virtual intervention demonstrated feasibility but did not significantly improve outcomes compared with controls. Within-group analysis found improvements in QoL for both H-V and H-IP. DISCUSSION: This study replicated the effectiveness of the HOBSCOTCH program in improving QoL for PWE. The study was conducted prior to the COVID-19 pandemic, but the distance-delivered intervention may be particularly well-suited for the current environment. Future research will explore modifications designed to improve the efficacy of H-V and the sustainability of HOBSCOTCH's treatment effect. TRIAL REGISTRATION INFORMATION: ClinicalTrials.gov (NCT02394509). CLASSIFICATION OF EVIDENCE: This study provides Class III evidence that in-person HOBSCOTCH delivery improved subjective measures of cognition in persons with epilepsy.
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COVID-19 , Epilepsia , Autogestão , Cognição , Epilepsia/psicologia , Epilepsia/terapia , Feminino , Humanos , Masculino , Pandemias , Qualidade de Vida/psicologiaRESUMO
BACKGROUND: Colonoscopy is frequently performed in older adults, yet data on current use, and clinical outcomes of and follow-up recommendations after colonoscopy in older adults are lacking. METHODS: This was an observational study using the New Hampshire Colonoscopy Registry of adults age ≥65 years undergoing colonoscopy for screening, surveillance of prior polyps, or evaluation of symptoms. The main outcomes were clinical findings of polyps and colorectal cancer and recommendations for future colonoscopy by age. RESULTS: Between 2009 and 2019, there were 42,611 colonoscopies, of which 17,527 (41%) were screening, 19,025 (45%) surveillance, and 6059 (14%) for the evaluation of symptoms. Mean age was 71.1 years (SD 5.0), and 49.3% were male. The finding of colorectal cancer was rare (0.71%), with the highest incidence among diagnostic examinations (2.4%). The incidence of advanced polyps increased with patient age from 65-69 to ≥85 years for screening (7.1% to 13.6%; p = 0.05) and surveillance (9.4% to 12.0%; p < 0.001). Recommendations for future colonoscopy decreased with age and varied by findings at current colonoscopy. In patients without any significant findings, 85% aged 70-74 years, 61.9% aged 75-79 years, 39.1% aged 80-84 years, and 27.4% aged ≥85 years (p < 0.001) were told to continue colonoscopy. Among patients with advanced polyps, 97.2% aged 70-74 years, 89.6% aged 75-79 years, 78.4% aged 80-84 years, and 66.7% aged ≥85 years were told to continue colonoscopy (p < 0.001). CONCLUSIONS: Within this comprehensive statewide registry, clinical findings during colonoscopy varied by indication and increased with age. Overall rates of finding advanced polyps and colorectal cancer are low. Older adults are frequently recommended to continue colonoscopy despite advanced age and insignificant clinical findings on current examination. These data inform the potential benefits of ongoing colonoscopy, which must be weighed with the low but known potential immediate and long-term harms of colonoscopy, including cost, psychological distress, and long lag time to benefit exceeding life expectancy.
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Neoplasias Colorretais , Idoso , Colonoscopia , Neoplasias Colorretais/diagnóstico , Neoplasias Colorretais/epidemiologia , Feminino , Humanos , Masculino , Programas de Rastreamento , New Hampshire/epidemiologia , Sistema de RegistrosRESUMO
Introduction: The COVID-19 pandemic resulted in an exponential increase in telehealth. In response to the pandemic, Dartmouth-Hitchcock Health (D-HH) and its Norris Cotton Cancer Center (NCCC) closed non-essential in-person services on March 17, 2020 and began reopening on April 27, 2020. We examined outpatient telehealth utilization at D-HH and NCCC in the peri-pandemic period and compared utilization to the Academic Medical Center (AMC) overall and to other service lines. Methods: Weekly outpatient volumes, percentage telehealth, percentage video versus audio-only, and percentage of new patients were examined for D-HH, for the AMC, and for selected AMC-based service lines from January 1 to October 31, 2020. Results: Compared with the AMC overall and with five other primarily non-surgical specialties, oncology was lower in the (1) proportion of outpatient visits performed via telehealth (example week 7/12/20: oncology = 11%; AMC = 21%; mean of 5 other specialties = 38%) and (2) percentage of telehealth involving video versus audio-only (7/12/20: oncology = 19%; AMC = 58%; mean of 5 others = 60%). Oncology more closely resembled the surgical specialty of orthopedics (7/12/20: 2% telehealth; 10% of telehealth involved video). Oncology also demonstrated (1) a high proportion of outpatient visits involving procedures (oncology = 22%; orthopedics = 12%) and (2) no difference between telehealth and in-person visits in terms of the percentage involving new patients. Conclusions: During the peri-pandemic period, our oncology service demonstrated a lower than average incorporation of telehealth overall into their outpatient practice and a lower proportion of telehealth performed by video. Further understanding these results and the drivers behind them will be integral for redesigning outpatient oncology care with optimal integration of telehealth.
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COVID-19 , Telemedicina , Centros Médicos Acadêmicos , COVID-19/epidemiologia , Humanos , Pacientes Ambulatoriais , PandemiasRESUMO
Rigorous scientific review of research protocols is critical to making funding decisions, and to the protection of both human and non-human research participants. Given the increasing complexity of research designs and data analysis methods, quantitative experts, such as biostatisticians, play an essential role in evaluating the rigor and reproducibility of proposed methods. However, there is a common misconception that a statistician's input is relevant only to sample size/power and statistical analysis sections of a protocol. The comprehensive nature of a biostatistical review coupled with limited guidance on key components of protocol review motived this work. Members of the Biostatistics, Epidemiology, and Research Design Special Interest Group of the Association for Clinical and Translational Science used a consensus approach to identify the elements of research protocols that a biostatistician should consider in a review, and provide specific guidance on how each element should be reviewed. We present the resulting review framework as an educational tool and guideline for biostatisticians navigating review boards and panels. We briefly describe the approach to developing the framework, and we provide a comprehensive checklist and guidance on review of each protocol element. We posit that the biostatistical reviewer, through their breadth of engagement across multiple disciplines and experience with a range of research designs, can and should contribute significantly beyond review of the statistical analysis plan and sample size justification. Through careful scientific review, we hope to prevent excess resource expenditure and risk to humans and animals on poorly planned studies.
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BACKGROUND: Pathogenic variants of the DPYD gene are strongly associated with grade ≥3 toxicity during fluoropyrimidine chemotherapy. We conducted a systematic review and meta-analysis to estimate the risk of treatment-related death associated with DPYD gene variants. MATERIALS AND METHODS: We searched for reports published prior to September 17, 2020, that described patients receiving standard-dose fluoropyrimidine chemotherapy (5-fluorouracil or capecitabine) who had baseline testing for at least one of four pathogenic DPYD variants (c.1129-5923C>G [HapB3], c.1679T>G [*13], c.1905+1G>A [*2A], and c.2846A>T) and were assessed for toxicity. Two reviewers assessed studies for inclusion and extracted study-level data. The primary outcome was the relative risk of treatment-related mortality for DPYD variant carriers versus noncarriers; we performed data synthesis using a Mantel-Haenszel fixed effects model. RESULTS: Of the 2,923 references screened, 35 studies involving 13,929 patients were included. DPYD variants (heterozygous or homozygous) were identified in 566 patients (4.1%). There were 14 treatment-related deaths in 13,363 patients without identified DPYD variants (treatment-related mortality, 0.1%; 95% confidence interval [CI], 0.1-0.2) and 13 treatment-related deaths in 566 patients with any of the four DPYD variants (treatment-related mortality, 2.3%; 95% CI, 1.3%-3.9%). Carriers of pathogenic DPYD gene variants had a 25.6 times increased risk of treatment-related death (95% CI, 12.1-53.9; p < .001). After excluding carriers of the more common but less deleterious c.1129-5923C>G variant, carriers of c.1679T>G, c.1905+1G>A, and/or c.2846A>T had treatment-related mortality of 3.7%. CONCLUSION: Patients with pathogenic DPYD gene variants who receive standard-dose fluoropyrimidine chemotherapy have greatly increased risk for treatment-related death. IMPLICATIONS FOR PRACTICE: The syndrome of dihydropyrimidine dehydrogenase (DPD) deficiency is an uncommon but well-described cause of severe toxicity related to fluoropyrimidine chemotherapy agents (5-fluorouracil and capecitabine). Patients with latent DPD deficiency can be identified preemptively with genotyping of the DPYD gene, or with measurement of the plasma uracil concentration. In this systematic review and meta-analysis, the authors study the rare outcome of treatment-related death after fluoropyrimidine chemotherapy. DPYD gene variants associated with DPD deficiency were linked to a 25.6 times increased risk of fluoropyrimidine-related mortality. These findings support the clinical utility of DPYD genotyping as a screening test for DPD deficiency.
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Observational clinical research studies aim to assess which exposures (treatments or other factors; independent variable) affect patient outcomes (dependent variable). These exposures include medical interventions in situations where clinical trials are not possible or prior to their conduct and completion. However, the assessment of the relationship between exposures and outcomes is not straightforward, as other variables may need to be considered prior to reaching valid conclusions. Here, we present three hypothetical scenarios in regional anesthesia to review the epidemiological concepts of confounding, mediation, and effect modification. Understanding these concepts is critical for assessing the design, analysis, and interpretation of clinical studies. These terms may be confusing to anesthesiologists and researchers alike, where such confusion could affect the conclusions of a clinical study, mislead the target audience, and ultimately impact patient health.
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Anestesiologistas , HumanosRESUMO
BACKGROUND: Snowmobiling is a popular activity that leads to geriatric trauma admissions; however, this unique trauma population is not well characterized. We aimed to compare the injury burden and outcomes for geriatric versus nongeriatric adults injured riding snowmobiles. MATERIALS AND METHODS: A retrospective cohort study was performed using the National Trauma Databank comparing nongeriatric (18-64) and geriatric adults (≥65) presenting after snowmobile-related trauma at level 1 and 2 trauma centers from 2011 to 2015. Demographic, admission, injury, and outcome data were collected and compared. A multivariate logistic regression model assessed for risk factors associated with severe injury (Injury Severity Score >15). Analysis was also performed using chi square, analysis of variance, and Kruskal-Wallis testing. RESULTS: A total of 2471 adult patients with snowmobile trauma were identified; 122 (4.9%) were geriatric. Rates of severe injury (Injury Severity Score >15) were similar between groups, 27.5% in geriatric patients and 22.5% in nongeriatric adults (P = 0.2). Geriatric patients experienced higher rates of lower extremity injury (50.4 versus 40.3%, P = 0.03), neck injury (4.1 versus 1.4%, P = 0.02), and severe spine injury (20.6 versus 7.0%, P = 0.004). Geriatric patients had longer hospitalizations (5 versus 3 d, P < 0.0001), rates of discharge to a facility (36.8% versus 12%, P < 0.0001), and higher mortality (4.1 versus 0.6%, P < 0.0001). Geriatric age did not independently increase the risk for severe injury. CONCLUSIONS: Geriatric age was not a significant predictor of severe injury after snowmobile trauma; however, geriatric patients suffered unique injuries, had longer hospitalizations, had higher rates of discharge to a facility, and had higher mortality. Tailored geriatric care may improve outcomes in this unique sport-related trauma population.
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Veículos Off-Road , Ferimentos e Lesões/epidemiologia , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Escala de Gravidade do Ferimento , Traumatismos da Perna/epidemiologia , Tempo de Internação , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Lesões do Pescoço/epidemiologia , Estudos Retrospectivos , Ferimentos e Lesões/mortalidade , Adulto JovemRESUMO
OBJECTIVE: The aryl hydrocarbon receptor (AHR) plays a key role in obesity. In vitro studies revealed that the tryptophan metabolite kynurenine (Kyn) activates AHR signaling in cultured hepatocytes. The objective of this study was to determine whether Kyn activated the AHR in mice to induce obesity. METHODS: Mice were fed a low-fat diet and the same diet supplemented with Kyn. Body mass, liver status, and the expression of identified relevant genes were determined. RESULTS: Kyn caused mice to gain significant body mass, develop fatty liver and hyperglycemia, and increase expression levels of cytochrome P450 1B1 and stearoyl-CoA desaturase 1. The hyperglycemia was accompanied with decreased insulin levels, which may have been due to the repression of genes involved in insulin secretion. Kyn plasma concentrations and BMI were measured in female patients, and a significant association was observed between Kyn and age in patients with obesity but not in patients who were lean. CONCLUSIONS: Results show that (1) Kyn or a metabolite thereof is a ligand responsible for inducing AHR-based obesity, fatty liver, and hyperglycemia in mice; (2) plasma Kyn levels increase with age in women with obesity but not in lean women; and (3) an activated AHR is necessary but not sufficient to attain obesity, a status that also requires fat in the diet.
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Fígado Gorduroso/metabolismo , Hiperglicemia/induzido quimicamente , Cinurenina/farmacologia , Receptores de Hidrocarboneto Arílico/metabolismo , Aumento de Peso/efeitos dos fármacos , Animais , Fígado/efeitos dos fármacos , Camundongos , Transdução de Sinais/efeitos dos fármacosRESUMO
BACKGROUND: Downhill skiing accounts for a large portion of geriatric sport-related trauma. We assessed the national burden of geriatric versus nongeriatric ski trauma. MATERIALS AND METHODS: Adults presenting to level 1/2 trauma centers after ski-associated injuries from 2011 to 2015 were identified from the National Trauma Data Bank by ICD-9 code. We compared demographics, injury patterns, and outcomes between geriatric (age ≥65 y) and nongeriatric adult skiers (age 18-64 y). A multiple regression analysis assessed for risk factors associated with severe injury (Injury Severity Score >15). RESULTS: We identified 3255 adult ski trauma patients, and 16.7% (543) were geriatric. Mean ages for nongeriatric versus geriatric skiers were 40.8 and 72.1 y, respectively. Geriatric skiers more often suffered head (36.7 versus 24.3%, P < 0.0001), severe head (abbreviated injury scale score >3, 49.0 versus 31.5%, P < 0.0001) and thorax injuries (22.2 versus 18.1%, P = 0.03) as compared with nongeriatric skiers. Geriatric skiers were also more often admitted to the ICU (26.5 versus 14.9%, P < 0.0001), discharged to a facility (26.7 versus 11.6%, P < 0.0001), and suffered higher mortality rates (1.3 versus 0.4%, P = 0.004). Independent risk factors for severe injury included being male (OR: 1.68, CI: 1.22-2.31), helmeted (OR: 1.41, CI: 1.07-1.85), and having comorbidities (OR: 1.37, CI: 1.05-1.80). Geriatric age was not independently associated with severe injury. CONCLUSIONS: At level 1/2 trauma centers, geriatric age in ski trauma victims was associated with unique injury patterns, higher acuity, increased rates of facility care at discharge, and higher mortality as compared with nongeriatric skiers. Our findings indicate the need for specialized care after high impact geriatric ski trauma.
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Efeitos Psicossociais da Doença , Traumatismos Craniocerebrais/epidemiologia , Esqui/lesões , Traumatismos Torácicos/epidemiologia , Centros de Traumatologia/estatística & dados numéricos , Adolescente , Adulto , Fatores Etários , Idoso , Comorbidade , Traumatismos Craniocerebrais/diagnóstico , Traumatismos Craniocerebrais/etiologia , Traumatismos Craniocerebrais/prevenção & controle , Bases de Dados Factuais , Feminino , Dispositivos de Proteção da Cabeça/estatística & dados numéricos , Mortalidade Hospitalar , Humanos , Escala de Gravidade do Ferimento , Unidades de Terapia Intensiva/estatística & dados numéricos , Tempo de Internação/estatística & dados numéricos , Masculino , Pessoa de Meia-Idade , Admissão do Paciente/estatística & dados numéricos , Estudos Retrospectivos , Fatores de Risco , Esqui/estatística & dados numéricos , Traumatismos Torácicos/diagnóstico , Traumatismos Torácicos/etiologia , Estados Unidos/epidemiologia , Adulto JovemRESUMO
The calculation of quality of care measures based on electronic medical records (EMRs) may be inaccurate because of incomplete capture of past services. We evaluate the influence of different statistical approaches for calculating the proportion of patients who are up-to-date for a preventive service, using the example of colorectal cancer (CRC) screening. We propose an extension of traditional mixture models to account for the uncertainty in compliance, which is further complicated by the choice of various screening modalities with different recommended screening intervals. We conducted simulation studies to compare various statistical approaches and demonstrated that the proposed method can alleviate bias when individuals with complete prior medical history information were not representative of the targeted population. The method is motivated by and applied to data from the National Cancer Institute-funded consortium Population-Based Research Optimizing Screening through Personalized Regiments (PROSPR). Findings from the application are important for the evaluation of appropriate use of preventive care and provide a novel tool for dealing with similar analytical challenges with EMR data in broad settings.
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BACKGROUND: Wire-localized excision of non-palpable breast cancer is imprecise, resulting in positive margins 15-35% of the time. METHODS: Women with a confirmed diagnosis of non-palpable invasive breast cancer (IBC) or ductal carcinoma in situ (DCIS) were randomized to a new technique using preoperative supine magnetic resonance imaging (MRI) with intraoperative optical scanning and tracking (MRI group) or wire-localized (WL group) partial mastectomy. The main outcome measure was the positive margin rate. RESULTS: In this study, 138 patients were randomly assigned. Sixty-six percent had IBC and DCIS, 22% had IBC, and 12% had DCIS. There were no differences in patient or tumor characteristics between the groups. The proportion of patients with positive margins in the MRI-guided surgery group was half that observed in the WL group (12 vs. 23%; p = 0.08). The specimen volumes in the MRI and WL groups did not differ significantly (74 ± 33.9 mL vs. 69.8 ± 25.1 mL; p = 0.45). The pathologic tumor diameters were underestimated by 2 cm or more in 4% of the cases by MRI and in 9% of the cases by mammography. Positive margins were observed in 68% and 58% of the cases underestimated by 2 cm or more using MRI and mammography, respectively, and in 15% and 14% of the cases not underestimated using MRI and mammography, respectively. CONCLUSIONS: A novel system using supine MRI images co-registered with intraoperative optical scanning and tracking enabled tumors to be resected with a trend toward a lower positive margin rate compared with wire-localized partial mastectomy. Margin positivity was more likely when imaging underestimated pathologic tumor size.