bluuebunny/crossref_metadata_2025_split huggingface dataset:
The value of co-creating a clinical outcome assessment strategy for clinical trial research: process and lessons learnt
Authors: Morel Thomas , Schroeder Karlin , Cleanthous Sophie , Andrejack John , Blavat Geraldine , Brooks William , Gosden Lesley , Siu Carroll , Ratcliffe Natasha , Slagle Ashley F. 
Published: October 2023

Abstract
Background
In support of UCB pharmaceutical research programs, the aim of this research was to implement a novel process for patient involvement in a multidisciplinary research group to co-create a clinical outcome assessment strategy to accurately reflect the experience of people living with early-stage Parkinson’s. Patient experts were an integral part of the decision-making process for patient-reported outcome (PRO) research and instrument development.

Methods
In partnership with two patient organizations (Parkinson’s UK and the Parkinson’s Foundation), 6 patient experts were recruited into a multidisciplinary research group alongside clinical, patient engagement and involvement, regulatory science, and outcome measurement experts. The group was involved across two phases of research; the first phase identified what symptoms are cardinal to the experience of living with early-stage Parkinson’s and the second phase involved the development of PRO instruments to better assess the symptoms that are important to people living with early-stage Parkinson’s. Patient experts were important in performing a variety of roles, in particular, qualitative study protocol design, conceptual model development, and subsequent co-creation of two PRO instruments.

Results
Involving people with Parkinson’s in PRO research ensured that the expertise of these representatives from the Parkinson’s community shaped and drove the research; as such, PRO instruments were being developed with the patient at the forefront. Working with patient experts required considerable resource and time allocation for planning, communication, document development, and organizing meetings; however, their input enriched the development of PRO instruments and was vital in developing PRO instruments that are more meaningful for people with Parkinson’s and clinicians.

Conclusions
Conducting PRO research, in the context of clinical development involving pharmaceutical companies, requires balancing regulatory and scientific rigor with tight time constraints. Incorporating a multi-stakeholder perspective, which included patient experts as joint investigators, had a strong positive impact on our research, despite the logistical complexities of their involvement. Due to the input of patient experts, the innovative clinical outcome assessment strategy and the co-created novel PRO instruments were more relevant and holistic to the patient experience of early-stage Parkinson’s.

Graphical abstract
Percutaneous liver interventions with robotic systems: a systematic review of available clinical solutions
Authors: Bodard Sylvain , Guinebert Sylvain , N. Petre Elena , Marinelli Brett , Sarkar Debkumar , Barral Matthias , H Cornelis Francois 
Published: October 2023

Objective
Robotic-guided interventions are emerging techniques that are gradually becoming a common tool for performing biopsies and tumor ablations in liver. This systematic review aims to evaluate their advancements, challenges, and outcomes.

Methods
A systematic review was conducted using the PubMed database to identify relevant articles published between January 2000 and February 2023. Inclusion criteria focused on studies that assessed robotic systems for percutaneous liver biopsies and tumor ablations. Data extraction was performed to collect information on study characteristics; robotic systems; components and software; imaging modality; degree of freedom; and needle insertion methods. The outcome measures analyzed were procedure time, radiation dose, and accuracy.

Results
10 studies met the inclusion criteria. The robotic devices used included MAXIO, EPIONE, ROBIO-EX, AcuBot, and ACE robotic systems. The data set consisted of 429 percutaneous thermal ablations and 57 biopsies, both robot-guided. On average, the mean deviation of probes was reduced by 30% (from 1.6 vs 3.3 mm to 2.4 vs 3.9 mm (p &lt; 0.001)), and 40% (p &lt; 0.05) fewer readjustments were required during the robotic-assisted interventions. Moreover, robotic systems contributed to a reduction in operating time, ranging from 15% (18.3 vs 21.7 min, p &lt; 0.001) to 25% (63.5 vs 87.4 min, p &lt; 0.001). Finally, the radiation dose delivered to both the patient and the operator was decreased by an average of 50% (p &lt; 0.05) compared to manual procedures.

Advances in knowledge
Robotic systems could provide precise navigation and guidance during liver biopsies and percutaneous ablations.
Duodenal volvulus of the sigmoid flexure in five cows. A retrospective study
Authors: Proios I , Hoedemaker M , Kiossis E 
Published: October 2023

Medical data of five Holstein Friesian cows with duodenal volvulus of the sigmoid flexure admitted to the Clinic for Cattle, University of Veterinary Medicine Hannover, Foundation, Hannover, Germany during a two-year period were reviewed in this study. The aim of this study was to present the clinical, laboratory and surgical findings as well as the postoperative healing progress and therapy of these five cases. All cows showed a loss of appetite and were dehydrated, with a marked drop in milk yield. The rumen motility was severely reduced and an untypical tympanic resonance or ping and a splashing sound were present at the right flank at auscultation. All the cows had only a small amount of faeces. All animals had hypochloraemic metabolic alkalosis and most of them hyperlactatemia. Two of the cows were hypokalaemic. Hyperbilirubinaemia was revealed in all cows. Four of the cows had an increased haematocrit level. A standing right flank laparotomy was performed in all cows. A common surgical finding was the severely dilated, dorsally dislocated and twisted sigmoid flexure of the duodenum, and the empty descending duodenum. The abomasum of all cows was dilated, but not displaced. An enlarged gall bladder was found in four animals. The duodenal sigmoid loop was manually untwisted, followed by promoting gas and ingesta flow aborally in the descending duodenum. Omentopexy was performed in each cow. No cow had had any history of omentopexy or other abdominal surgery. All cows received intravenous fluid therapy after the surgery. A total of 10-20 L 0.9 % NaCl solution containing an additional KCL (30 mmol/L) was administered intravenously via drip infusion daily for the first two days after surgery. Amoxicillin (10 mg/kg; s.c.) was administered once daily (SID) in two cases. Three of the cows were additionally drenched with 30 L water and 100-150 g KCL via an orogastric tube once per day for two days postoperatively. Four cows received neostigmine s.c. after surgery and for the following one to two days (every 8 or 12 hours; 0.02 mg/kg or 0.025 mg/kg, respectively). All cows were administered meloxicam (0.5 mg/kg; s.c.) before and on the first postoperative day. Sodium sulphate (250 g per os; SID) was administered to four cows for one to two days. Feed intake, rumen motility and defaecation were normalised gradually after surgery. All cows had a positive post-surgical outcome and were discharged from the clinic after 7 to 15 days.
Keywords: ileus; dairy cattle; duodenum; intestinal obstruction
Machine Learning for Data-Driven Last-Mile Delivery Optimization
Authors: Özarık Sami Serkan , da Costa Paulo , Florio Alexandre M. 
Published: October 2023

In the context of the Amazon Last-Mile Routing Research Challenge, this paper presents a machine-learning framework for optimizing last-mile delivery routes. Contrary to most routing problems where an objective function is clearly defined, in the real-world setting considered in the challenge, an objective is not explicitly specified and must be inferred from data. Leveraging techniques from machine learning and classical traveling salesman problem heuristics, we propose a “pool and select” algorithm to prescribe high-quality last-mile delivery sequences. In the pooling phase, we exploit structural knowledge acquired from data, such as common entry and exit regions observed in training routes. In the selection phase, we predict the scores of candidate sequences with a high-dimensional, pretrained, and regularized regression model. The score prediction model, which includes a large number of predictor variables such as sequence duration, compliance with time windows, earliness, lateness, and structural similarity to training data, displays good prediction accuracy and guides the selection of efficient delivery sequences. Overall, the framework is able to prescribe competitive delivery routes, as measured on out-of-sample routes across several data sets. Given that desired characteristics of high-quality sequences are learned and not assumed, the proposed framework is expected to generalize well to last-mile applications beyond those immediately foreseen in the challenge. Moreover, the method requires less than three seconds to prescribe a sequence given an instance and, thus, is suitable for very large-scale applications. History: This paper has been accepted for the Transportation Science Special Issue on Machine Learning Methods and Applications in Large-Scale Route Planning Problems. Funding: This research was funded by The Dutch Research Council (NWO) Data2Move project under [Grant 628.009.013] and the European Union’s Horizon 2020 research and innovation programme under the Marie Sklodowska-Curie [Grant 754462]. Supplemental Material: The online appendix is available at https://doi.org/10.1287/trsc.2022.0029 .
Confiança em Robôs Socialmente Assistivos: Um Catálogo de Requisitos Não-Funcionais
Authors: Rodrigues Da Costa Larissa , Castro Jaelson , Kelner Judith , Lencastre Maria 
Published: October 2023

Resumo: Contexto: A confiança (trust) é um aspecto muito importante para a interação com robôs socialmente assistivos (SARs). Confiança em Engenharia de Requisitos é considerada um requisito não-funcional requisito a ser satisfeito, e as fases de elicitação e especificação dos requisitos de confiança contribuem diretamente para a qualidade dos SARs. Na literatura, há uma escassez de trabalhos que abordam a Confiança no contexto de SARs. Objetivo: Propor um catálogo de Requisitos Não-Funcionais de Confiança para Robôs Socialmente Assistivos - NFR4TRUST, voltado para robôs do tipo humanoide. Método: Condução de uma revisão da literatura abrangendo o contexto da confiança na interação humano-robô e automação. Organização de uma taxonomia de confiança para SARs que serve como base para a criação do Catálogo. Validação do catálogo através da definição de requisitos de confiança de um robô que auxilia na reabilitação de membros superiores e realização de entrevistas com especialistas nas áreas de NFR Framework, interação humano-robô, confiança, engenharia de requisitos e fisioterapia. Resultados: O catálogo foi considerado pelos especialistas e engenheiros de requisitos consultados como um artefato valioso e que apresenta uma boa cobertura inicial em relação aos requisitos não-funcionais de confiança no domínio de SARs humanoides. Conclusão: O NFR4TRUST foi considerado um artefato útil para apoiar as etapas de elicitação e especificação em projetos de robôs socialmente assistivos do tipo humanoide, permitindo a identificação de possíveis problemas sobre a perspectiva de confiança.
Fifteen-year prospective longitudinal cohort study of outcomes following single radius total knee arthroplasty
Authors: Scott Chloe E. H. , Snowden Gordon T. , Cawley Will , Bell Katrina R. , MacDonald Deborah J. , Macpherson Gavin J. , Yapp Liam Z. , Clement Nick D. 
Published: October 2023

AimsThis prospective study reports longitudinal, within-patient, patient-reported outcome measures (PROMs) over a 15-year period following cemented single radius total knee arthroplasty (TKA). Secondary aims included reporting PROMs trajectory, 15-year implant survival, and patient attrition from follow-up.MethodsFrom 2006 to 2007, 462 consecutive cemented cruciate-retaining Triathlon TKAs were implanted in 426 patients (mean age 69 years (21 to 89); 290 (62.7%) female). PROMs (12-item Short Form Survey (SF-12), Oxford Knee Score (OKS), and satisfaction) were assessed preoperatively and at one, five, ten, and 15 years. Kaplan-Meier survival and univariate analysis were performed.ResultsAt 15 years, 28 patients were lost to follow-up (6.1%) and 221 patients (51.9%) had died, with the mean age of the remaining cohort reducing by four years. PROMs response rates among surviving patients were: one-year 63%; five-year 72%; ten-year 94%; and 15-year 59%. OKS and SF-12 scores changed significantly over 15 years (p < 0.001). The mean improvement in OKS was 18.8 (95% confidence (CI) 16.7 to 19.0) at one year. OKS peaked at five years (median 43 years) declining thereafter (p < 0.001), though at 15 years it remained 17.5 better than preoperatively. Age and sex did not alter this trajectory. A quarter of patients experienced a clinically significant decline (≥ 7) in OKS from five to ten years and from ten to 15 years. The SF-12 physical component score displayed a similar trajectory, peaking at one year (p < 0.001). Patient satisfaction was 88% at one, five, and ten years, and 94% at 15 years. In all, 15-year Kaplan-Meier survival was 97.6% (95% CI 96.0% to 99.2%) for any revision, and 98.9% (95% CI 97.9% to 99.9%) for aseptic revision.ConclusionImprovements in PROMs were significant and maintained following single radius TKA, with OKS peaking at five years, and generic physical health peaking at one year. Patient satisfaction remained high at 15 years, at which point 2.4% had been revised.Cite this article: Bone Jt Open 2023;4(10):808–816.
Electronic cigarette use during pregnancy and the risk of adverse birth outcomes: A cross-sectional surveillance study of the US Pregnancy Risk Assessment Monitoring System (PRAMS) population
Authors: Ammar Lin , Tindle Hilary A. , Miller Angela M. , Adgent Margaret A. , Nian Hui , Ryckman Kelli K. , Mogos Mulubrhan , Piano Mariann R. , Xie Ethan , Snyder Brittney M. , Ramesh Abhismitha , Yu Chang , Hartert Tina V. , Wu Pingsheng 
Published: October 2023

Background
Research on health effects and potential harms of electronic cigarette (EC) use during pregnancy is limited. We sought to determine the risks of pregnancy EC use on pregnancy-related adverse birth outcomes and assess whether quitting ECs reduces the risks.

Methods
Women with singleton live births who participated in the US Pregnancy Risk Assessment Monitoring System (PRAMS) survey study 2016–2020 were classified into four mutually exclusive groups, by their use of ECs and combustible cigarettes (CCs) during pregnancy: non-use, EC only use, CC only use, and dual use. We determined the risk of preterm birth, low birth weight, and small-for-gestational-age (SGA) by comparing cigarette users to non-users with a modified Poisson regression model adjusting for covariates. In a subset of women who all used ECs prior to pregnancy, we determined whether quitting EC use reduces the risk of preterm birth, low birth weight, and SGA by comparing to those who continued its use. All analyses were weighted to account for the PRAMS survey design and non-response rate.

Results
Of the 190,707 women (weighted N = 10,202,413) included, 92.1% reported cigarette non-use, 0.5% EC only use, 6.7% CC only use, and 0.7% dual use during pregnancy. Compared with non-use, EC only use was associated with a significantly increased risk of preterm birth (adjusted risk ratio [aRR]: 1.29, 95% confidence interval [CI]: 1.00, 1.65) and low birth weight (aRR: 1.38, 95%CI: 1.09, 1.75), but not SGA (aRR: 1.04, 95%CI: 0.76, 1.44). Among 7,877 (weighted N = 422,533) women EC users, quitting use was associated with a significantly reduced risk of low birth weight (aRR: 0.76, 95%CI: 0.62, 0.94) and SGA (aRR: 0.77, 95%CI: 0.62, 0.94) compared to those who continued to use ECs during pregnancy.

Conclusions
Pregnancy EC use, by itself or dual use with CC, is associated with preterm birth and low birth weight. Quitting use reduces that risk. ECs should not be considered as a safe alternative nor a viable gestational smoking cessation strategy.
Association between the first 24 hours PaCO2 and all-cause mortality of patients suffering from sepsis-associated encephalopathy after ICU admission: A retrospective study
Authors: Luo Honglian , Li Gang , Yang Bingxin , Huang Xinlei , Chen Yan , Shen Wei 
Published: October 2023

Objective
The relationship between the levels of the first 24-h PaCO2 and the prognosis of sepsis-associated encephalopathy (SAE) remains unclear, and the first 24-h optimal target for PaCO2 is currently inconclusive. This study was performed to investigate the correlation between PaCO2 and all-cause mortality for SAE patients, establish a reference range of the initial 24-hour PaCO2 for clinicians in critical care, and explain the possible pathophysiological mechanisms of abnormal PaCO2 levels as a higher mortality risk factor for SAE.

Methods
The baseline information and clinical data of patients were extracted from the fourth edition Medical Information Mart for Intensive Care database (MIMIC-IV 2.0). Multivariate logistic regressions were performed to assess the relationship between PaCO2 and all-cause mortality of SAE. Additionally, restricted cubic splines, Kaplan-Meier Survival analyses, propensity score matching (PSM) analyses, and subgroup analyses were conducted.

Results
A total of 5471 patients were included in our cohort. In the original and matched cohort, multivariate logistic regression analysis showed that normocapnia and mild hypercapnia may be associated with a more favorable prognosis of SAE patients, and survival analysis supported the findings. In addition, a U-shaped association emerged when examining the initial 24-hour PaCO2 levels in relation to 30-day, 60-day, and 90-day mortality using restricted cubic splines, with an average cut-off value of 36.3mmHg (P for nonlinearity<0.05). Below the cut-off value, higher PaCO2 was associated with lower all-cause mortality, while above the cut-off value, higher PaCO2 was associated with higher all-cause mortality. Subsequent subgroup analyses revealed similar results for the subcohort of GCS≤8 compared to the original cohort. Additionally, when examining the subcohort of GCS>8, a L-shaped relationship between PaCO2 and the three clinical endpoints emerged, in contrast to the previously observed U-shaped pattern. The findings from the subcohort of GCS>8 suggested that patients experiencing hypocapnia had a more unfavorable prognosis, which aligns with the results obtained from corresponding multivariate logistic regression analyses.

Conclusion
The retrospective study revealed the association between the first 24-h PaCO2 and all-cause mortality risk (30-day, 60-day, and 90-day) for patients with SAE in ICU. The range (35mmHg-50mmHg) of PaCO2 may be the optimal target for patients with SAE in clinical practice.
Validating the Arabic version of the Connor-Davidson resilience scale among university students
Authors: Alfuqaha Othman A. 
Published: October 2023

Background
The Connor-Davidson Resilience Scale (CD-RISC) stands out as a widely used measure of psychological resilience. The original CD-RISC consists of 25 items, commonly referred to as CD-RISC-25.

Aim
This study aims to validate the Arabic version of the CD-RISC-25 involving a sample size of 1220 participants from three universities in Jordan.

Methods
The researcher conducted a methodological investigation to examine the validation process. This included an examination of the translation process and an evaluation of content validity, which was assessed using the content validity index (CVI). Construct validity was assessed through exploratory factor analysis and confirmatory factor analysis, while convergent and discriminant validity were both evaluated using composite reliability (CR) and the square root of the average variance extracted.

Results
Results showed a prominent level of psychological resilience 76.74±15.2 among the participating university students. Regarding the validity of the Arabic version of CD-RISC-25, the CVI yielded a value of 0.88, signifying a robust level of content validity. The analysis identified four constructs that accounted for 56.26% of the total variance. The goodness-of-fit indices, including goodness of fit index of 0.91, comparative fit index of 0.91, incremental fit index of 0.93, Tucker-Lewis index of 0.94, and root mean square error of approximation of 0.048, provided strong evidence supporting the alignment between the observed data and the hypothesized constructs. Discriminant and convergent validity were found to support the validity of the Arabic version of CD-RISC-25. Regarding the reliability, it demonstrated excellent reliability, with a total Cronbach’s alpha of 0.934 and all CR values surpassing the threshold of 0.70, thereby further establishing its overall robustness.

Conclusion
The results provide substantial evidence for the validity and reliability of the translated Arabic CD-RISC-25.
The prognostic impact of body mass index on female breast cancer patients in underdeveloped regions of northern China differs by menopause status and tumor molecular subtype
Authors: Ma Lijun , Liu Ailan , Gao Jinnan , Zhao Haoliang 
Published: October 2023

Abstract
There is growing evidence that higher body mass index (BMI) is associated with lower survival in breast cancer patients. The aim of this study was to investigate whether there is an association between body mass index (BMI) at breast cancer diagnosis and breast cancer prognosis and whether this association is dependent on menopausal status and tumor subtype in a less developed population in northern China. We collected 1,225 patients with primary invasive cancer in stage I-IIIC for retrospective analysis from October 2010 to December 2020. We used Kaplan–Meier and Cox regression analyses and estimated the relationship between baseline BMI and breast cancer-specific survival (BCSS). Next, we further evaluated whether the effect of BMI on breast cancer prognosis differed by menopausal status and tumor subtype. We found that death rate and prognosis were worse for patients with BMI ≥ 24, more than four positive lymph nodes, and triple negative status. Interestingly, BMI played a different prognostic role depending on tumor subtype and menopausal status. For premenopausal women, patients with BMI ≥ 24 had significantly lower BCSS compared to those with BMI < 24 in human epidermal growth factor receptor 2 (HER2) overexpression (HR: 4.305, p = 0.004) and triple negative subtypes (HR: 1.775, p = 0.048). By contrast, there was no association between BMI ≥ 24 and higher death regardless of tumor subtype in post-menopausal patients (p > 0.05). BMI influences breast cancer outcome depending on tumor subtype and menopause. BMI ≥ 24 might be a risk factor for BCSS, particularly in premenopausal women with HER2 overexpression or triple negative subtype. In contrast, BMI ≥ 24 was not associated with higher death regardless of tumor subtype in post-menopausal patients.