bluuebunny/crossref_metadata_2025_split huggingface dataset:
Durable Response Seen in Patients With Refractory Fistulizing Perianal Crohn’s Disease Using Autologous Mesenchymal Stem Cells on a Dissolvable Matrix: Results from the Phase I Stem Cell on Matrix Plug (STOMP) Trial
Authors: Dozois Eric J. , Lightner Amy L. , Dietz Allan B. , Fletcher Joel G. , Lee Yong S. , Friton Jessica J. , Faubion William A. 
Published: December 2022

BACKGROUND:
Refractory perianal Crohn’s disease remains notoriously difficult to treat. We developed a novel technology using a commercially available bioabsorbable fistula plug to deliver autologous adipose derived mesenchymal stem cells.

OBJECTIVE:
Assess therapeutic safety and feasibility in the completed STOMP trial.

DESIGN:
Prospective single-arm phase I clinical trial.

SETTING:
Tertiary academic medical center.

PATIENTS:
Adults (18-65) with complex single tract Crohn’s disease perianal fistula who have failed conventional therapy.

INTERVENTION:
Autologous adipose derived mesenchymal stem cells were isolated, ex vivo culture-expanded, and seeded onto a commercially available bioabsorbable fistula plug. Six weeks later, patients returned to the operating room for removal of the seton and placement of the stem cell-loaded plug.

MAIN OUTCOME MEASURES:
Patients were followed for a total of 8 visits through 12 months. Safety was the primary endpoint; clinical healing and MRI response were secondary endpoints.

RESULTS:
Twenty patients (12 female, mean age 36 years) were treated with the stem cell-loaded plug. Of the 20 patients enrolled, three were not included in the 12 month analysis due to study withdrawal. Through 12 months, no patient experienced a serious adverse event related to the stem cell-loaded plug. Four patients experienced 7 serious adverse events and 12 patients experienced 22 adverse events. Complete clinical healing occurred in 14 of 18 patients at 6 months and 13 of 17 patients at 12 months. MRI response was observed in 12 of 18 patients at 6 months.

LIMITATIONS:
The main limitations are the small sample size and restrictive inclusion criteria.

CONCLUSIONS:
A stem cell-loaded plug can safely and effectively deliver cell-based therapy for patients with single tract fistulizing perianal Crohn’s disease. See Video Abstract at http://links.lww.com/DCR/C70.
Re-do Continent Ileostomy in Inflammatory Bowel Disease Patients: Valuable Lessons Learned Over 25 years
Authors: Duraes Leonardo C. , Holubar Stefan D. , Lipman Jeremy M , Hull Tracy L. , Lightner Amy L. , Lavryk Olga A. , Kanters Arielle E. , Steele Scott R. 
Published: December 2022

BACKGROUND:
Inflammatory bowel disease patients with continent ileostomies may require revision surgeries. There remains a paucity of data regarding outcomes after re-do continent ileostomy.

OBJECTIVE:
Evaluate the outcomes following re-do continent ileostomy.

DESIGN:
Retrospective cohort study.

SETTINGS:
High volume, specialized colorectal surgery department.

PATIENTS:
We identified patients who underwent re-do continent ileostomy (defined as neo-pouch construction or major operations changing the pouch configuration) for inflammatory bowel disease between 1994 and 2020.

MAIN OUTCOME MEASURES:
Patient demographics, short- and long-term outcomes, and quality-of-life.

RESULTS:
A total of 168 patients met inclusion criteria; 102 (61%) were female, the mean age was 51 years (±13.1), and the mean BMI was 24.4 (±3.9). The median time between primary and re-do continent ileostomy was 16.8 years. One hundred twenty-two patients (73%) who underwent re-do surgery had ulcerative colitis, 36 (21%) had Crohn's disease, and 10 (6%) had indeterminate colitis. Slipped nipple valve and valve stricture were the most common indications for re-do continent ileostomy (86%). After a median follow-up of 4 years, 48 (29%) patients required a subsequent reoperation, and 27 (16%) had pouch failure requiring pouch excision. The pouch survival rate was 89% at 3 years, 84% at 5 years, and 79% at 10 years. On univariate analysis, a shorter time interval between the primary and re-do continent ileostomy was associated with long-term pouch failure (p = 0.003). Cox regression multivariate analysis confirmed that shorter interval between surgeries was independently associated with pouch failure (p = 0.014). The mean Global Quality-of-Life score was 0.61 (± 0.23) among the 70 patients who responded to the questionnaire.

LIMITATIONS:
Retrospective, single-center study. Low response rate for Quality-of-Life questionnaire.

CONCLUSION:
Re-do continent ileostomy surgery is associated with long-term pouch retention rate of 79% and satisfactory quality-of-life. Therefore, re-do surgery should be offered to patients who are motivated to keep their continent ileostomy. See Video Abstract at http://links.lww.com/DCR/C87.
Walking Endurance and Oxygen Uptake On-Kinetics in Individuals With Parkinson Disease Following Overground Locomotor Training
Authors: Pechstein Andrew E. , Gollie Jared M. , Keyser Randall E. , Guccione Andrew A. 
Published: December 2022

Background and Purpose:
Poor walking endurance in Parkinson disease (PD) may be attributable to both bioenergetic and biomechanical factors, but locomotor training methods addressing both these factors simultaneously are understudied. Our objective was to examine the effects of overground locomotor training (OLT) on walking endurance in individuals with mild-to-moderate PD, and to further explore potential cardiorespiratory contributions.

Methods:
A single-arm, longitudinal design was used to examine the effects of 24 biweekly sessions of OLT in people with mild-to-moderate PD (n = 12). Walking endurance was measured as total distance walked during a 10-minute walk test (10minWT). Oxygen uptake (V˙o
2) on-kinetic profiles were determined using a monoexponential function. Perceived fatigability was assessed following the 10minWT using a self-report scale. Magnitude of change in primary outcomes was assessed using Cohen's d and adjusted for sample size (Cohen's d
(unbiased)).

Results:
Participants executed 3036 (297) steps and maintained 65.5% (8%) age-predicted heart rate maximum in a typical session lasting 56.9 (2.5) minutes. Medium effects in total distance walked—885.9 (157.2) versus 969.5 (140.9); Cohen's d
(unbiased) = 0.54—and phase II time constant of the V˙o
2 on-kinetic profile—33.7 (12.3) versus 25.9 (15.3); Cohen's d
(unbiased) = 0.54—were observed alongside trivial effects for perceived fatigability—4.7 (1.4) versus 4.8 (1.5); Cohen's d
(unbiased) = 0.11—following OLT.

Discussion and Conclusions:
These preliminary findings may demonstrate the potential for moderate-intensity OLT to improve walking endurance and enhance cardiorespiratory adjustments to walking activity in adults with mild-to-moderate PD.

Video Abstract available for more insights from the authors (see the Video, Supplemental Digital Content 1, http://links.lww.com/JNPT/A407).
A Hybrid Assessment of Clinical Mobility Test Items for Evaluating Individuals With Mild Traumatic Brain Injury
Authors: Fino Peter C. , Michielutti Patrick G. , Pelo Ryan , Parrington Lucy , Dibble Leland E. , Hoppes Carrie W. , Lester Mark E. , Weightman Margaret M. , King Laurie A. 
Published: December 2022

Background and Purpose:
The Functional Gait Assessment (FGA) and High Level Mobility Assessment Tool (HiMAT) are clinical batteries used to assess people with mild traumatic brain injury (mTBI). However, neither assessment was specifically developed for people with mTBI; the FGA was developed to evaluate vestibular deficits, and the HiMAT was developed for individuals with more severe TBI. To maximize the sensitivity and reduce the time burden of these assessments, the purpose of this study was to determine the combination of FGA and HiMAT items that best discriminates persons with persistent symptoms from mTBI from healthy controls.

Methods:
Fifty-three symptomatic civilians with persistent symptoms from mTBI (21% male, aged 31 (9.5) years, 328 [267] days since concussion) and 57 healthy adults (28% male, aged 32 (9.6) years) participated across 3 sites. The FGA and HiMAT were evaluated sequentially as part of a larger study. To determine the best combination of items, a lasso-based generalized linear model (glm) was fit to all data.

Results:
The area under the curve (AUC) for FGA and HiMAT total scores was 0.68 and 0.66, respectively. Lasso regression selected 4 items, including FGA Gait with Horizontal Head Turns and with Pivot Turn, and HiMAT Fast Forward and Backward Walk, and yielded an AUC (95% confidence interval) of 0.71 (0.61-0.79) using standard scoring.

Discussion and Conclusions:
The results provide initial evidence supporting a reduced, 4-Item Hybrid Assessment of Mobility for mTBI (HAM-4-mTBI) for monitoring individuals with mTBI. Future work should validate the HAM-4-mTBI and investigate its utility for tracking progression throughout rehabilitation.

Video Abstract available for more insights from the authors (see the Video, Supplemental Digital Content 1, http://links.lww.com/JNPT/A409).
Nationwide Validation Study of the Prognostic Significance of Stratification Using Pathological Stage and Response to Neoadjuvant Chemotherapy for Esophageal Squamous Cell Carcinoma
Authors: Matsuda Satoru , Kitagawa Yuko , Okui Jun , Okamura Akihiko , Kawakubo Hirofumi , Takemura Ryo , Muto Manabu , Kakeji Yoshihiro , Takeuchi Hiroya , Watanabe Masayuki , Doki Yuichiro 
Published: December 2022

Objective:
This study aimed to validate the prognostic significance of stratification using pathological stage and response to neoadjuvant chemotherapy with a nationwide database from an authorized institute by the Japan Esophageal Society.

Background:
We proposed the combined criteria using pStage and pathological response. Conducting a validation study using an expanded cohort in the clinical setting would be valuable since it was developed using retrospective data collection.

Methods:
Patients with esophageal squamous cell carcinoma who underwent subtotal esophagectomy at 85 authorized institutes were retrospectively reviewed for esophageal cancer between 2010 and 2015. The prognostic value of the pathological response was evaluated within the same pStage. Moreover, risk stratification was developed to predict cancer-specific survival (CSS).

Results:
The pathological response showed significant stratification of CSS in 3761 patients included in this analysis. We classified the patients into 7 groups as survival was significantly different between responders and nonresponders under the stratification with pStage, excluding pStage I comprising pStage 0–I/II responder/II nonresponder/III responder/III nonresponder/IV responder/IV nonresponder with the 5-year CSS of 83.7%/75.8%/68.9%/59.8%/44.4%/40.7%/23.1%, respectively. Furthermore, the area under the curve was significantly higher under the new classification than in the pStage alone (P<0.001).

Conclusions:
The prognostic value of classification using pStage and the pathological response was successfully validated using real-world data in Japan. This result would guide appropriate treatment for patients with esophageal squamous cell carcinoma who received neoadjuvant chemotherapy followed by esophagectomy.
Health System Structure
Authors: Brooks Ezra S. , Mavroudis Catherine L. , Tong Jason , Wirtalla Christopher J. , Friedman Ari , Kelz Rachel R. 
Published: December 2022

Objective:
To examine the role of hub-and-spoke systems as a factor in structural racism and discrimination.

Background:
Health systems are often organized in a “hub-and-spoke” manner to centralize complex surgical care to 1 high-volume hospital. Although the surgical health care disparities are well described across health care systems, it is not known how they seem across a single system’s hospitals.

Methods:
Adult patients who underwent 1 of 10 general surgery operations in 12 geographically diverse states (2016–2018) were identified using the Healthcare Cost and Utilization Project’s State Inpatient Databases. System status was assigned using the American Hospital Association dataset. Hub designation was assigned in 2 ways: (1) the hospital performing the most complex operations (general hub) or (2) the hospital performing the most of each specific operation (procedure-specific hub). Independent multivariable logistic regression was used to evaluate the risk-adjusted odds of treatment at hubs by race and ethnicity.

Results:
We identified 122,236 patients across 133 hospitals in 43 systems. Most patients were White (73.4%), 14.2% were Black, and 12.4% Hispanic. A smaller proportion of Black and Hispanic patient underwent operations at general hubs compared with White patients (B: 59.6% H: 52.0% W: 62.0%, P<0.001). After adjustment, Black and Hispanic patients were less likely to receive care at hub hospitals relative to White patients for common and complex operations (general hub B: odds ratio: 0.88 CI, 0.85, 0.91 H: OR: 0.82 CI, 0.79, 0.85).

Conclusions:
When White, Black, and Hispanic patients seek care at hospital systems, Black and Hispanic patients are less likely to receive treatment at hub hospitals. Given the published advantages of high-volume care, this new finding may highlight an opportunity in the pursuit of health equity.
Understanding How Experts Do It
Authors: Grover Karan , Korenblit Nechama , Babu Archana , Podolsky Dina , Carbonell Alfredo , Orenstein Sean , Pauli Eric M. , Novitsky Yuri , Madani Amin , Sullivan Maura , Nieman Dylan 
Published: December 2022

Background:
The safe and effective performance of a posterior component separation via a transversus abdominis release (TAR) requires intraoperative judgement and decision-making skills that are difficult to define, standardize, and teach. We herein present the first qualitative study which builds a framework upon which training and objective evaluation of a TAR can be based.

Methods:
Hierarchical and cognitive task analyses for a TAR procedure were performed using semistructured interviews of hernia experts to describe the thoughts and behaviors that exemplify optimal performance. Verbal data was recorded, transcribed, coded, and thematically analyzed.

Results:
A conceptual framework was synthesized based on literary sources (4 book chapters, 4 peer-reviewed articles, 3 online videos), 2 field observations, and interviews of 4 hernia experts [median 66 minutes (44–78)]. Subject matter experts practiced a median of 6.5 years (1.5–16) and have completed a median of 300 (60–500) TARs. After 5 rounds of inductive analysis, 80 subtasks, 86 potential errors, 36 cognitive behaviors, and 17 decision points were identified and categorized into 10 procedural steps (midline laparotomy, adhesiolysis, retrorectus dissection, etc.) and 9 fundamental principles: patient physiology and disease burden; tactical modification; tissue reconstruction and wound healing; task completion; choice of technique and instruments; safe planes and danger zones; exposure, ergonomics, environmental limitations; anticipation and forward planning; and tissue trauma and handling.

Conclusion:
This is the first study to define the key tasks, decisions, and cognitive behaviors that are essential to a successful TAR procedure.
Transfusion-free Strategies in Liver and Pancreatic Surgery
Authors: Kulkarni Sujit , Parina Ralitza , Henderson Randy , Derek Elika , Selby Taylor , Kwon Yong , Emamaullee Juliet , Sher Linda , Genyk Yuri , Selby Rick 
Published: December 2022

Objective:
The objective of this study is to (1) describe the techniques and prove the feasibility of performing complex hepatobiliary and pancreatic surgery on a Jehovah Witness (JW) population.  (2) Describe a strategy that offsets surgical blood loss by the manipulation of circulating blood volume to create reserve whole blood upon anesthesia induction.

Background:
Major liver and pancreatic resections often require operative transfusions. This limits surgical options for patients who do not accept major blood component transfusions. There is also growing recognition of the negative impact of allogenic blood transfusions.

Methods:
A 23-year, single-center, retrospective review of JW patients undergoing liver and pancreatic resections was performed. We describe perioperative management and patient outcomes. Acute normovolemic hemodilution (ANH) is proposed as an important strategy for offsetting blood losses and preventing the need for blood transfusion. A quantitative mathematical formula is developed to provide guidance for its use.

Results:
One hundred one major resections were analyzed (liver n=57, pancreas n=44). ANH was utilized in 72 patients (liver n=38, pancreas n=34) with median removal of 2 units that were returned for hemorrhage as needed or at the completion of operation. There were no perioperative mortalities. Morbidity classified as Clavien grade 3 or higher occurred in 7.0% of liver resection and 15.9% of pancreatic resection patients.

Conclusions:
Deliberate perioperative management makes transfusion-free liver and pancreatic resections feasible. Intraoperative whole blood removal with ANH specifically preserves red cell mass, platelets, and coagulation factors for timely reinfusion. Application of the described JW transfusion-free strategy to a broader general population could lessen blood utilization costs and morbidities.
A Step Toward Personalized Surgical Decision Making
Authors: Meneveau Max O. , Vavolizza Rick D. , Mohammad Anwaruddin , Kumar Pankaj , Manderfield Joseph T. , Callahan Colleen , Lynch Kevin T. , Abbas Tarek , Slingluff Craig L. , Bekiranov Stefan 
Published: December 2022

Objective:Develop a predictive model to identify patients with 1 pathologic lymph node (pLN) versus >1 pLN using machine learning applied to gene expression profiles and clinical data as input variables.Background:Standard management for clinically detected melanoma lymph node metastases is complete therapeutic LN dissection (TLND). However, >40% of patients with a clinically detected melanoma lymph node will only have 1 pLN on final review. Recent data suggest that targeted excision of just the single enlarged LN may provide excellent regional control, with less morbidity than TLND. The selection of patients for less morbid surgery requires accurate identification of those with only 1 pLN.Methods:The Cancer Genome Atlas database was used to identify patients who underwent TLND for melanoma. Pathology reports in The Cancer Genome Atlas were reviewed to identify the number of pLNs. Patients were included for machine learning analyses if RNA sequencing data were available from a pLN. After feature selection, the top 20 gene expression and clinical input features were used to train a ridge logistic regression model to predict patients with 1 pLN versus >1 pLN using 10-fold cross-validation on 80% of samples. The model was then tested on the remaining holdout samples.Results:A total of 153 patients met inclusion criteria: 64 with one pLN (42%) and 89 with >1 pLNs (58%). Feature selection identified 1 clinical (extranodal extension) and 19 gene expression variables used to predict patients with 1 pLN versus >1 pLN. The ridge logistic regression model identified patient groups with an accuracy of 90% and an area under the receiver operating characteristic curve of 0.97.Conclusions:Gene expression profiles together with clinical variables can distinguish melanoma metastasis patients with 1 pLN versus >1 pLN. Future models trained using positron emission tomography/computed tomography imaging, gene expression, and relevant clinical variables may further improve accuracy and may predict patients who can be managed with a targeted LN excision rather than a complete TLND.
Factors Associated With Provision of Nonbeneficial Surgery
Authors: Zaza Sarah I. , Zimmermann Christopher J. , Taylor Lauren J. , Kalbfell Elle L. , Stalter Lily , Brasel Karen , Arnold Robert M. , Cooper Zara , Schwarze Margaret L. 
Published: December 2022

Objective:
We tested the association of systems factors with the surgeon’s likelihood of offering surgical intervention for older adults with life-limiting acute surgical conditions.

Background:
Use of surgical treatments in the last year of life is frequent. Improved risk prediction and clinician communication are solutions proposed to improve serious illness care, yet systems factors may also drive receipt of nonbeneficial treatment.

Methods:
We mailed a national survey to 5200 surgeons randomly selected from the American College of Surgeons database comprised of a clinical vignette describing a seriously ill older adult with an acute surgical condition, which utilized a 2×2 factorial design to assess patient and systems factors on receipt of surgical treatment to surgeons.

Results:
Two thousand one hundred sixty-one surgeons responded for a weighted response rate of 53%. For an 87-year-old patient with fulminant colitis and advanced dementia or stage IV lung cancer, 40% of surgeons were inclined to offer an operation to remove the patient’s colon while 60% were inclined to offer comfort-focused care only. Surgeons were more likely to offer surgery when an operating room was readily available (odds ratio: 4.05, P<0.001) and the family requests “do everything” (odds ratio: 2.18, P<0.001).

Conclusions:
Factors outside the surgeon’s control contribute to nonbeneficial surgery, consistent with our model of clinical momentum. Further characterization of the systems in which these decisions occur might expose novel strategies to improve serious illness care for older patients and their families.
Long-term Mortality and Reintervention After Endovascular and Open Abdominal Aortic Aneurysm Repairs in Australia, Germany, and the United States
Authors: Mao Jialin , Behrendt Christian-Alexander , Falster Michael O. , Varcoe Ramon L. , Zheng Xinyan , Peters Frederik , Beiles Barry , Schermerhorn Marc L. , Jorm Louisa , Beck Adam W. , Sedrakyan Art 
Published: December 2022

Objective:
To examine long-term outcomes after endovascular (EVAR) and open repairs (OAR) for intact abdominal aortic aneurysms in Australia, Germany, and the United States, using a unified study design.

Background:
Similarities and differences in long-term outcomes after EVAR versus OAR across countries remained unclear, given differences in designs across existing studies.

Methods:
We identified patients aged >65 years undergoing intact abdominal aortic aneurysm repairs during 2010-2017/2018. We compared long-term patient mortality and reintervention after EVAR and OAR using Kaplan-Meier analyses and Cox regressions. Propensity score matching was performed within each country to adjust for differences in baseline patient characteristics between procedure groups.

Results:
We included 3311, 4909, and 145363 patients from Australia, Germany, and the United States, respectively. The median patient age was 76 to 77 years, and most patients were males (77%–84%). Patient mortality was lower after EVAR than OAR within the first 60 days and became similar at 3-year follow-up (Australia 14.7% vs 16.5%, Germany 18.2% vs 19.7%, United States: 24.4% vs 24.4%). At the end of follow-up, patient mortality after EVAR was higher than OAR in Australia [ hazard ratio (HR) 95% CI: 1.21 (0.96-1.54)] but similar to OAR in Germany [HR 95% CI: 0.92 (0.80-1.07)] and the United States [HR 95% CI: 1.02 (0.99-1.05)]. The risk of reintervention after EVAR was more than twice that after OAR in Australia [HR 95% CI: 2.60 (1.09-6.15)], Germany [HR 95% CI: 4.79 (2.56-8.98)], and the United States [HR 95% CI: 2.67 (2.38-3.00)]. The difference in reintervention risk appeared early in German and United States patients.

Conclusions:
This multinational study demonstrated important similarities in long-term outcomes after EVAR versus OAR across 3 countries. Variation in long-term mortality and reintervention comparisons indicates possible differences in patient profiles, surveillance, and best medical therapy across countries.