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A Latent Trait-based Measure as a Data Harmonization and Missing Data Solution Applied to the Environmental Influences on Child Health Outcomes Cohort
No full textBACKGROUND: Collaborative research consortia provide an efficient method to increase sample size, enabling evaluation of subgroup heterogeneity and rare outcomes. In addition to missing data challenges faced by all cohort studies like nonresponse and attrition, collaborative studies have missing data due to differences in study design and measurement of the contributing studies.
METHODS: We extend ROSETTA, a latent variable method that creates common measures across datasets collecting the same latent constructs with only partial overlap in measures, to define a common measure of socioeconomic status (SES) across cohorts with varying indicators in the Environmental influences on Child Health Outcomes Cohort, a consortium of pregnancy and pediatric cohorts.
RESULTS: Starting with 52 indicators of prenatal SES from 39,372 participants across 53 cohorts, ROSETTA created three factors representing key domains of SES: income and education, insurance and poverty, and unemployment. At least one factor score was available for 34,528 participants; two factors were available for more participants than any single indicator. Factors fit the data well, had content validity, and were correlated with alternative measures of SES (for income & education factor, r= 0.40-0.89). Higher SES as measured by the factor scores was associated with lower odds of prenatal smoking:OR income & education 0.42 (95% CI 0.38, 0.45). Missing data were reduced compared to most methods, except for multiple imputation.
CONCLUSIONS: ROSETTA aids in pooled analysis of individual participant data by creating measures on a common scale and maximizing data in the presence of missing and mismatched measures
Association of Enhanced Recovery After Surgery (ERAS) with textbook outcomes among patients undergoing surgery for rectal cancer
No full textBACKGROUND: Surgical resection is the cornerstone of rectal cancer treatment but can be associated with adverse short-term postoperative outcomes. We sought to assess the factors associated with achievement of optimal outcomes among patients undergoing surgery for rectal cancer.
METHODS: In this multicenter retrospective cohort study, the US Rectal Cancer Consortium database was used to identify patients who underwent surgery for nonmetastatic rectal cancer between 2007 and 2018. The primary outcome was achievement of a Textbook Outcome. A Textbook Outcome is a composite outcome defined as the absence of any postoperative complications, extended length of stay (\u3e75th percentile), 90-day readmission, and 90-day mortality. Multivariable logistic regression analyses were conducted to identify factors associated with the achievement of a Textbook Outcome, and reported as odds ratios and 95% confidence intervals.
RESULTS: Among 1,102 patients who underwent surgery for rectal cancer, Textbook Outcome was achieved by 41.8% (n = 461) of patients. On multivariable analyses, American Society of Anesthesiologists-Physical Status \u3e2 (odds ratio 0.66, 95% confidence interval 0.50-0.88), diabetes (0.57, 0.38-0.87), operative time \u3e3.5 hours (0.52, 0.39-0.69), and perioperative packed red blood cells transfusion (0.20, 0.12-0.34) were associated with decreased odds of achieving a Textbook Outcome. Conversely, Enhanced Recovery After Surgery was associated with increased odds of achieving a Textbook Outcome (1.93, 1.45-2.58).
CONCLUSIONS AND RELEVANCE: Despite improvement in recent years, short-term outcomes after rectal cancer surgery remain suboptimal. Patient optimization strategies such as Enhanced Recovery After Surgery are essential to facilitate the achievement of optimal outcomes in patients undergoing rectal cancer surgery
Concordance of surgical treatment selection with the AUA guidelines for localized renal masses
No full textOBJECTIVE: To examine and evaluate guideline concordance of surgical treatment selection at a community-based health system. The AUA guidelines provide specific guidance regarding appropriate utilization of radical nephrectomy (RN) and partial nephrectomy (PN). However, nearly 40% of patients did not fit a guideline-specified scenario in a prior report.
METHODS: Retrospective review of consecutive surgical patients (7/2019-9/2022) identified indications for RN/PN relative to 3 criteria: tumor complexity (RENAL ≥ 9), oncologic risk (size ≥ 7cm, cT3a, infiltrative features, and/or renal mass biopsy with high-risk features), and renal function (preoperative GFR ≥ 60 ml/min/1.73m(2); predicted GFR following RN ≥ 45 ml/min/1.73m(2)).
RESULTS: Of 372 surgeries for cT1a-cT3aN0M0 renal masses, 138 were RN (37%) and 234 were PN (63%). Overall, 247 patients (66%) fit a guideline-specified scenario: 35 (9%) had a strong indication for RN of whom 34 underwent RN (97%) and 212 (57%) had a strong indication for PN of whom 191 underwent PN (90%). Of 125 patients (34% of total) that did not fit guidelines scenarios, 83 underwent RN (66%) and 42 underwent PN (34%). Oncologic risk was the most influential factor in both guideline-specified and non-specified cases with 96% of patients with high-oncologic risk undergoing RN whether renal function was adequate or impaired. Fellowship-trained urologic-oncologists were more likely to perform PN than general urologists for non-specified cases (47% vs. 28%, P \u3c 0.001).
CONCLUSION: We found strong AUA guideline compliance for RN and PN with some over-utilization of RN. Our results confirm that more than one third of cases are uncategorized. Subsequent iterations of guidelines could incorporate more cases by expanding indications for appropriate RN. Regardless, complex cases may benefit from tumor boards and multidisciplinary review
Transjugular Transcatheter Tricuspid Valve Replacement in Patients With Cardiac Implantable Electronic Devices
No full textBACKGROUND: Cardiac implantable electronic device (CIED)-related tricuspid regurgitation (TR) is common. Transcatheter tricuspid valve replacement (TTVR) is feasible with CIEDs in the right ventricle; however, data in this population are limited.
OBJECTIVES: This study retrospectively analyzed patients undergoing compassionate-use transjugular TTVR with the LuX-Valve Plus for symptomatic TR with CIEDs from January 2022 to August 2024 at 17 international centers.
METHODS: The primary endpoint was procedural TR reduction. Secondary endpoints included TR reduction, survival at 30 days, New York Heart Association functional class changes, and CIED function at follow-up. Non-CIED group was used for comparison.
RESULTS: Of 99 patients, 36 (36.4%) had CIEDs. Baseline characteristics were similar, though the CIED group had a higher EuroSCORE (European System for Cardiac Operative Risk Evaluation) II score and more comorbidities. Procedural success (CIED vs non-CIED: 91.7% vs 95.2%; P = 0.781), 30-day mortality (5.6% vs 4.8%; P \u3e 0.999), TR reduction (≤1+: 83.8% vs 84.9%; P \u3e 0.999), and NYHA functional class I/II (80.8% vs 83.7%; P = 0.89) were comparable. The CIED cohort exhibited a higher numerical incidence of conversion to surgery (8.3% vs 1.6%) and tricuspid reintervention (11.5% vs 3.3%) within 6 months; however, these differences did not reach statistical significance (P = 0.267 and P = 0.160, respectively). Of the 22 patients with postoperative interrogation (median of 3.3 months), 9.1% of CIED patients exhibited worsening device parameters, with no need for lead replacement or extraction.
CONCLUSIONS: Transjugular TTVR is safe and effective for managing TR and heart failure in patients with CIEDs. Due to the small sample size, these findings highlight the need for larger, prospective studies to validate these outcomes
Clinical trial design, biomarkers and end points in metabolic and alcohol-related liver disease
No full textMetabolic and alcohol-related liver disease (MetALD) is a newly defined entity within the spectrum of steatotic liver disease, characterized by the interplay of cardiometabolic risk factors and alcohol consumption. The evolving epidemiology and complex pathophysiology of MetALD present unique challenges and opportunities for clinical trial design. Inclusion criteria should require simultaneous evidence of metabolic dysfunction (at least two cardiometabolic features) and verified quantifiable alcohol exposure recorded over the preceding 3-6 months. Traditional histological end points are limited by invasiveness, sampling error and interpretative variability. Thus, imaging modalities, serum-based fibrosis biomarkers and quantitative measures of alcohol intake are gaining relevance as non-invasive, reproducible and patient-centric end points aiming to improve trial feasibility. Furthermore, incorporating alcohol biomarkers, stratifying patients by metabolic risk factor burden, and using adaptive designs of trials might enhance the precision and generalizability of MetALD clinical trials. Although uncertainties remain regarding optimal patient selection criteria, event rates and the dynamic interplay between metabolic dysfunction and alcohol intake, ongoing research efforts aim to refine diagnostic criteria, standardize methodologies and validate novel end points. These advances will ultimately accelerate drug development, improve trial efficiency and foster interventions to treat MetALD
Leveraging de-implementation science to promote infection prevention and stewardship: a roadmap and practical examples (Part II of II)
No full textDe-implementation of established practices is a common challenge in infection prevention and antimicrobial stewardship and a necessary part of the life cycle of healthcare quality improvement programs. Promoting de-implementation of ineffective antimicrobial use and increasingly of low-value diagnostic testing are cornerstones of stewardship practice. Principles of de-implementation science and the interplay of implementation and de-implementation are discussed in part I of this Society for Healthcare Epidemiology of America White Paper Series.In this second part of the series, we discuss a process for applying principles of de-implementation science in infection prevention and stewardship and then review some real-world examples and case studies, including a national blood culture shortage, contact precautions, and surgical and dental prophylaxis. We use these examples to demonstrate how barriers and facilitators can be mapped to evidence-informed implementation/de-implementation strategies to promote efforts to reduce low-value, ineffective, or out-of-date practices. These real-world examples highlight the need for infection prevention and stewardship programs to adapt to changing evidence, contexts, and conditions. Although barriers to practice change are often a bit different, de-implementation can sometimes be thought of as the implementation of a new program-but the new program aims to stop rather than start doing something.As the saying goes, sometimes less really is more. Medicine and public health have a strong action bias and a strong aversion to risk and uncertainty. Although our best intentions may point us to implementing more interventions, often, the best medicine instead dictates that we do less, or nothing at all. Leveraging principles of de-implementation science can help move healthcare in the right direction when interventions are low-value, ineffective, or no longer needed
Wound Irrigation Prior to Closure During Routine Upper-Extremity Surgery: Is There a Difference in Wound Complications?
No full textBACKGROUND: Presently, there is no consensus within the field of orthopedics on whether irrigation prior to wound closure in routine upper-extremity surgery reduces wound complications. Therefore, preclosure wound irrigation could provide time and cost savings. The aim of this study was to evaluate the effectiveness of wound irrigation in routine upper-extremity procedures.
METHODS: We conducted a retrospective review of adult patients undergoing routine upper-extremity surgery at a single institution from 2013 to 2022. Patients were included if they underwent soft tissue upper extremity surgery. Patients were excluded for having concomitant lacerations, penetrating injuries, open fractures, or unknown irrigation technique. Our primary outcome was comparison of the rate of wound complications based on whether irrigation was used. Multivariable logistic regression was additionally used to determine whether irrigation prior to closure was associated with a lower incidence of postoperative wound complications independent of potential confounders.
RESULTS: We included 1425 patients. The mean age was 55.2 ± 16 years and 65% were female. The incision was irrigated prior to closure in 65% of surgeries. Wound complications occurred in 2.9% of patients (n = 41). On bivariable analysis, irrigation prior to closure was not associated with a decreased incidence of wound complications (3.5% vs 1.8%, P = .070). When adjusting for age, sex, BMI, operative time, history of prior surgery, diabetes, tobacco use, corticosteroid use, and immunosuppressant use, the employment of irrigation prior to wound closure was not associated with lower odds of wound complications in either bivariable (OR: 1.99, 95% CI 0.94-4.19, P = .07) or multivariable (OR: 1.88, 95% CI 0.88-4.04, P = .08) analysis.
CONCLUSION: Use of irrigation prior to wound closure was not associated with a difference in the odds of postoperative wound complications. Surgeons should consider forgoing irrigation prior to closure to increase operating room efficiency and provide cost savings to the patients and payers
Changes in Gray Matter Morphology and White Matter Microstructure Across the Adult Lifespan in People With Temporal Lobe Epilepsy
No full textBACKGROUND AND OBJECTIVES: Temporal lobe epilepsy (TLE) is commonly associated with mesiotemporal pathology and widespread alterations of gray and white matter structures. Evidence supports a progressive condition, although the temporal evolution of TLE is poorly defined. In this ENIGMA-Epilepsy study, we aim to investigate structural alterations in gray and white matter across the adult lifespan in patients with TLE by charting both gray and white matter changes and explore the covariance of age-related alterations in both compartments.
METHODS: Mega-analysis of parcellated T1-weighted and diffusion MRI data across 18 international sites for patients with TLE was compared against healthy controls. We combined median-age split groupwise comparisons with cross-sectional sliding age-window analyses to explore gray (cortical thickness, subcortical volume) and white matter microstructure (fractional anisotropy, mean diffusivity) age-related changes. Five-year range age windows were constructed from mean z scores of all patients. Covariance analyses examined the coupled correlations of gray and white matter lifespan curves for each region.
RESULTS: We studied 769 patients with TLE and 885 healthy controls across an age range of 17-73 years. Robust (p(FDR) \u3c 0.05) gray matter thickness/volume decline (d \u3c -0.20) was seen across a broad cortico-subcortical territory, extending beyond the mesiotemporal lobe throughout the adult lifespan in patients with TLE. White matter changes were also widespread across multiple fiber tracts with peak effects in temporolimbic fibers in fractional anisotropy (d \u3c -0.3, p(FDR) \u3c 0.05) and mean diffusivity measures (d \u3e 0.3, p(FDR) \u3c 0.05). Changes spanned the adult time window and effects exceeded typical aging-related processes in patients at the level of cortical thickness, subcortical volume, and diffusion measures, particularly in patients older than 55 years. Covariance analyses revealed strong associations across multiple white matter tracts, subcortical structures, and cortical regions within and beyond the temporolimbic system.
DISCUSSION: This study highlights that patients with TLE exhibit more pronounced and widespread gray and white matter atrophy across the lifespan. The cross-sectional nature of our study limits definitive conclusions on whether the atrophy shown is progressive but emphasizes the importance of prompt diagnosis and intervention in patients. Collectively, our results motivate future longitudinal studies to clarify consequences of drug-resistant epilepsy
Role of rehabilitation in palliative care after the COVID-19 pandemic: a narrative review
No full textBACKGROUND AND OBJECTIVE: The coronavirus disease 2019 (COVID-19) pandemic resulted in an historic disruption and transformation of the healthcare system, including the management of individuals with serious illness. Rehabilitation for patients facing serious or life-threatening illness is underutilized and poorly understood, resulting in unwarranted suffering, disability, and poorly coordinated care. This narrative review aims to describe the impact of the COVID-19 pandemic on the role and scope of rehabilitation within the context of serious illness and palliative care.
METHODS: A focused review of the literature included selected articles identified from three databases published from January 2020 to January 2025. Findings were synthesized narratively, with a focus on identifying themes and gaps in the literature related to two main topics: (I) the evidence related to rehabilitation for those with serious or life-threatening COVID-19 during the pandemic and (II) how rehabilitation for patients with serious illness has been transformed after emerging from the pandemic (including non-COVID diagnoses such as cancer, neurologic conditions, etc.).
KEY CONTENT AND FINDINGS: The key themes identified during the COVID-19 pandemic emphasized the need for early rehabilitation, interdisciplinary care, and an emphasis on cardiopulmonary principles for rehabilitation. Themes identified during the pandemic also included the emerging role of telerehabilitation, and need for evidence and clinical guidelines for serious illnesses (including long COVID). Themes related to the transformative effect on palliative rehabilitation after the pandemic included an increased importance and focus on coordination of care and interdisciplinary care for those with serious illness and increased focus on mental health and social determinants of health (SDOH). Additionally, there appears to be increased infrastructure and activity related to research, advocacy, and awareness for palliative rehabilitation.
CONCLUSIONS: The COVID-19 global pandemic highlighted the need for high quality, coordinated palliative care, including rehabilitation services, for patients facing a serious or life-threatening illness. Due to the benefits to a person\u27s quality of life (QoL), dignity, and comfort, there is increasing evidence of the importance of seamless, ongoing access to rehabilitation services for patients with serious illness