bluuebunny/crossref_metadata_2025_split huggingface dataset:
Characterizing rescue performance in a tertiary care medical center: a systems approach to provide management decision support
Authors: McGrath Susan P. , MacKenzie Todd , Perreard Irina , Blike George 
Published: August 2021

Abstract
Background
Allocation of limited resources to improve quality, patient safety, and outcomes is a decision-making challenge health care leaders face every day. While much valuable health care management research has concentrated on administrative data analysis, this approach often falls short of providing actionable information essential for effective management of specific system implementations and complex systems. This comprehensive performance analysis of a hospital-wide system illustrates application of various analysis approaches to support understanding specific system behaviors and identify leverage points for improvement. The study focuses on performance of a hospital rescue system supporting early recognition and response to patient deterioration, which is essential to reduce preventable inpatient deaths.

Methods
Retrospective analysis of tertiary care hospital inpatient and rescue data was conducted using a systems analysis approach to characterize: patient demographics; rescue activation types and locations; temporal patterns of activation; and associations of patient factors, including complications, with post-rescue care disposition and outcomes.

Results
Increases in bedside consultations (20% per year) were found with increased rescue activations during periods of resource limitations and changes (e.g., shift changes, weekends). Cardiac arrest, respiratory failure, and sepsis complications present the highest risk for rescue and death. Distributions of incidence of rescue and death by day of patient stay may suggest opportunities for earlier recognition.

Conclusions
Specific findings highlight the potential of using rescue-related risk and targeted resource deployment strategies to improve early detection of deterioration. The approach and methods applied can be used by other institutions to understand performance and allow rational incremental improvements to complex care delivery systems.
Choice of HbA1c threshold for identifying individuals at high risk of type 2 diabetes and implications for diabetes prevention programmes: a cohort study
Authors: Rodgers Lauren R. , Hill Anita V. , Dennis John M. , Craig Zoe , May Benedict , Hattersley Andrew T. , McDonald Timothy J. , Andrews Rob C. , Jones Angus , Shields Beverley M. 
Published: August 2021

Abstract
Background
Type 2 diabetes (T2D) is common and increasing in prevalence. It is possible to prevent or delay T2D using lifestyle intervention programmes. Entry to these programmes is usually determined by a measure of glycaemia in the ‘intermediate’ range. This paper investigated the relationship between HbA1c and future diabetes risk and determined the impact of varying thresholds to identify those at high risk of developing T2D.

Methods
We studied 4227 participants without diabetes aged ≥ 40 years recruited to the Exeter 10,000 population cohort in South West England. HbA1c was measured at study recruitment with repeat HbA1c available as part of usual care. Absolute risk of developing diabetes within 5 years, defined by HbA1c ≥ 48 mmol/mol (6.5%), according to baseline HbA1c, was assessed by a flexible parametric survival model.

Results
The overall absolute 5-year risk (95% CI) of developing T2D in the cohort was 4.2% (3.6, 4.8%). This rose to 7.1% (6.1, 8.2%) in the 56% (n = 2358/4224) of participants classified ‘high-risk’ with HbA1c ≥ 39 mmol/mol (5.7%; ADA criteria). Under IEC criteria, HbA1c ≥ 42 mmol/mol (6.0%), 22% (n = 929/4277) of the cohort was classified high-risk with 5-year risk 14.9% (12.6, 17.2%). Those with the highest HbA1c values (44–47 mmol/mol [6.2–6.4%]) had much higher 5-year risk, 26.4% (22.0, 30.5%) compared with 2.1% (1.5, 2.6%) for 39–41 mmol/mol (5.7–5.9%) and 7.0% (5.4, 8.6%) for 42–43 mmol/mol (6.0–6.1%). Changing the entry criterion to prevention programmes from 39 to 42 mmol/mol (5.7–6.0%) reduced the proportion classified high-risk by 61%, and increased the positive predictive value (PPV) from 5.8 to 12.4% with negligible impact on the negative predictive value (NPV), 99.6% to 99.1%. Increasing the threshold further, to 44 mmol/mol (6.2%), reduced those classified high-risk by 59%, and markedly increased the PPV from 12.4 to 23.2% and had little impact on the NPV (99.1% to 98.5%).

Conclusions
A large proportion of people are identified as high-risk using current thresholds. Increasing the risk threshold markedly reduces the number of people that would be classified as high-risk and entered into prevention programmes, although this must be balanced against cases missed. Raising the entry threshold would allow limited intervention opportunities to be focused on those most likely to develop T2D.
Intellectual property and access to medicines: mapping public attitudes toward pharmaceuticals during the United States-Mexico-Canada Agreement (USMCA) negotiation process
Authors: Wong Anna S. Y. , Cole Clarke B. , Kohler Jillian C. 
Published: August 2021

Abstract
Background
Transparency and accountability are essential components at all stages of the trade negotiation process. This study evaluates the extent to which these principles were upheld in the United States’ public consultation process during the negotiation of the United States-Mexico-Canada Agreement (USMCA), with respect to public comments about the pharmaceutical sector and access to medicines.

Results
The public consultation process occurred before the start of official negotiations and was overseen by the Office of the United States Trade Representative (USTR). It included both written comments and oral testimony about US trade negotiation objectives. Of the written comments that specifically discussed issues relating to pharmaceuticals, the majority were submitted by private individuals, members of the pharmaceutical industry, and civil society organizations. Nearly all comments submitted by non-industry groups indicated that access to medicines was a priority issue in the renegotiated agreement, with specific reference to price affordability. By contrast, more than 50% of submissions received from members or affiliates of the pharmaceutical industry advocated for strengthened pharmaceutical intellectual property rights, greater regulatory data protections, or both.
This study reveals mixed outcomes with respect to the level of transparency achieved in the US trade negotiation process. Though input from the public at-large was actively solicited, the extent to which these comments were considered in the content of the final agreement is unclear. A preliminary comparison of the analyzed comments with the USTR’s final negotiating objectives and the final text of the USMCA shows that several provisions that were advanced exclusively by the pharmaceutical industry and ultimately adopted in the final agreement were opposed by the majority of non-industry stakeholders.

Conclusions
Negotiators could increase public transparency when choosing to advance one competing trade objective over another by actively providing the public with clear rationales for their negotiation positions, as well as details on how public comments are taken into account to form these rationales. Without greater clarity on these aspects, the public consultation process risks appearing to serve as a cursory government mechanism, lacking in accountability and undermining public trust in both the trade negotiation process and its outcomes.
Validation of the Spanish version of the Goodman score in total hip arthroplasty
Authors: Brañes Julián , Barahona Maximiliano , Carvajal Sebastián , Wulf Rodrigo , Barrientos Cristián 
Published: August 2021

Abstract
Purpose
Currently, patient-reported outcome measures (PROMs) are the standard instruments used to compare arthroplasty results. Goodman et al. recently published a well-constructed scale with excellent psychometric properties that can be quickly administered. The main objective of our study was to translate, culturally adapt, and validate a Spanish version of the Goodman questionnaire in patients who underwent total hip arthroplasty (THA).

Methods
The original Goodman scale was translated into Spanish and cross-culturally adapted. Then, the data from this version were tested for psychometric quality. We designed a cross-sectional study for data collection. This study enrolled 2 institutions. Patients who underwent hip replacement due to primary osteoarthritis secondary to dysplasia between 1 January 2018 and 31 December 2019 were included. A total of 153 patients were contacted twice to record the Goodman and Oxford hip scales (OHS) to assess the validity of the questionnaire. Reliability was tested using the Cronbach’s alpha, Concordance using 3 test: intraclass correlation coefficient (ICC), Lin's concordance correlation coefficient (CCC), and the Bradley-Blackwood F test. The spearman correlation was used to asses correlation between the OHS and the Spanish-adapted Goodman scale.

Results
The overall satisfaction after THA was reported to be “very satisfied” by 137 patients (75%), and only 14 patients reported some degree of dissatisfaction (6%). The improvement in quality of life was reported to be “more than I ever dreamed possible” by 41% patients. Cronbach’s alpha was acceptable, reaching a coefficient of 0.95 (95% confidence interval, 0.82–1). No statistical difference (t test, p = 0.55) was found in the original version, with great internal validity. Test re-test concordance was optimal among the 3 tests used. A moderate correlation was found between the OHS and the Spanish-adapted Goodman scale.

Conclusion
The Spanish version of the Goodman questionnaire in THA is a reliable, consistent, and feasible scale to evaluate patient satisfaction and improvement in the quality of life in Spanish speakers.
Functional outcome and complication following THA through modified direct anterior approach correlated to cadaveric study: are there any differences in Asian hip?
Authors: Phruetthiphat Ong-art , Sangthumprateep Vasin , Trakulngernthai Songpol , Aegakkatajit Noppadol , Chotanaphuti Thanainit , Chanpoo Malee 
Published: August 2021

AbstractBackgroundDirect anterior approach (DAA) has several advantages including shorter length of hospital stay, faster recovery, and better functional outcome while this approach may cause damage to the lateral femoral cutaneous nerve (LFCN) as high as 81% in the works of literature. Not much data has identified the LFCN pattern in the Asian population. Therefore, the purpose of our study was to identify characteristics of the LFCN patterns representing an Asian hip, which would aid to provide the most appropriate incision of modified direct anterior approach (MDAA) for total hip arthroplasty (THA), and to identify the clinical outcome and complications following THA through MDAA correlated with cadaveric hip in the Asian population.MethodsAfter IRB approval, a cadaveric study was done to identify pattern and course of the LFCN in Asian population. The MDAA defined as the incision 2 fingerbreadths posteriorly to anterior superior iliac spine to avoid injury to the LFCN. The clinical phase identified 32 patients who underwent THA because of late-stage osteoarthritis of the hip. The anterolateral skin numbness was measured along tensor fascia lata between 2 weeks until 2 years. The functional outcome assessed by Harris Hip Score (HHS) and complications were evaluated in all patients.ResultsThe characteristics of the LFCN from cadaveric study (phase 1) was predominantly in sartorius type (60.0%) followed by posterior type (26.6%), fan type (6.7%), and variant type (6.7%). The clinical phase demonstrated that 23 patients (71.9%) had no numbness while 9 patients (28.1%) came with numbness after undergoing THA through the MDAA. Finally, a small area of skin numbness remained in only 3 patients (9.4%) at 2 years follow-up. Additionally, there was no significant difference in functional score at 2 years follow-up (89.0 vs 91.2,p= 0.422) between those with LFCN injury and those without LFCN injury.ConclusionsThe LFCNs were divided into four types. Modified direct anterior approach, which is an alternative approach for THA, allowing for a lower rate of skin numbness and faster recovery without hip dislocation, abductor weakness, and serious nerve complication. Functional outcome was comparable with and without LFCN injury.Level of evidenceLevel II, prospective observation study
Cell-free stem cell-derived extract formulation for treatment of knee osteoarthritis: study protocol for a preliminary non-randomized, open-label, multi-center feasibility and safety study
Authors: Gupta Ashim , Maffulli Nicola , Rodriguez Hugo C. , Mistovich R. Justin , Delfino Kristin , Cady Craig , Fauser Anne-Marie , Cundiff Echo D. , Martinez Marte A. , Potty Anish G. 
Published: August 2021

Abstract
Background
Musculoskeletal conditions are highly prevalent, and knee OA is most common. Current treatment modalities have limitations and either fail to solve the underlying pathophysiology or are highly invasive. To address these limitations, attention has focused on the use of biologics. The efficacy of these devices is attributed to presence of growth factors (GFs), cytokines (CKs), and extracellular vesicles (EVs). With this in mind, we formulated a novel cell-free stem cell-derived extract (CCM) from human progenitor endothelial stem cells (hPESCs). A preliminary study demonstrated the presence of essential components of regenerative medicine, namely GFs, CKs, and EVs, including exosomes, in CCM. The proposed study aims to evaluate the safety and efficacy of intraarticular injection of the novel cell-free stem cell-derived extract (CCM) for the treatment of knee OA.

Methods and analysis
This is a non-randomized, open-label, multi-center, prospective study in which the safety and efficacy of intraarticular CCM in patients suffering from grade II/III knee OA will be evaluated. Up to 20 patients with grade II/III OA who meet the inclusion and exclusion criteria will be consented and screened to recruit 12 patients to receive treatment. The study will be conducted at up to 2 sites within the USA, and the 12 participants will be followed for 24 months. The study participants will be monitored for adverse reactions and assessed using Numeric Pain Rating Scale (NPRS), Patient-Reported Outcomes Measurement Information System (PROMIS) Score, Knee Injury and Osteoarthritis Outcome Score Jr. (KOOS Jr.), 36-ietm short form survey (SF-36), Single Assessment Numeric Evaluation (SANE), physical exams, plain radiography, and magnetic resonance imaging (MRI) with Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) score for improvements in pain, function, satisfaction, and cartilage regeneration.

Discussion
This prospective study will provide valuable information into the safety and efficacy of intraarticular administration of cell-free stem cell-derived extract (CCM) in patients suffering with grade II/III knee OA. The outcomes from this initial study of novel CCM will lay the foundation for a larger randomized, placebo-controlled, multi-center clinical trial of intraarticular CCM for symptomatic knee OA.

Trial registration
Registered on July 21, 2021. ClinicalTrials.gov NCT04971798
Is there a difference in the outcomes of anterior cervical discectomy and fusion among female patients with different menopausal statuses?
Authors: Wang Xing-jin , Liu Hao , He Jun-bo , Gong Quan , Hong Ying , Rong Xin , Ding Chen , Wang Bei-yu , Yang Yi , Meng Yang 
Published: August 2021

Abstract
Background
The surgical outcomes of anterior cervical discectomy and fusion (ACDF) in female patients according to menopausal status remain unclear. The objective of this study was to investigate the differences in these outcomes among female patients with different menopausal statuses.

Methods
Ninety-one patients undergoing single-level or consecutive two-level ACDF with a minimum 12-month postoperative follow-up were included in this study. There were 38 patients in the premenopausal group, 28 patients in the early postmenopausal group, and 25 patients in the late postmenopausal group. The clinical outcomes were evaluated by means of the neck disability index (NDI) scores, Japanese Orthopedic Association (JOA) scores, and visual analog scale (VAS) scores. Radiological parameters included cervical lordosis (CL), the functional spinal unit (FSU) angle, range of motion (ROM) of the total cervical spine, ROM of the FSU, anterior and posterior FSU height, implant subsidence, adjacent segment degeneration (ASD), and Hounsfield unit (HU) values.

Results
All groups showed significant improvements in their JOA, VAS, and NDI scores (P < 0.05). The differences in preoperative and final follow-up CL, ROM of C2-7, FSU angle, and ROM of FSU were not statistically significant among the three groups (P > 0.05). The anterior FSU height loss rate showed a significant difference (P = 0.043), while there was no difference in the posterior FSU height loss rate (P = 0.072). The fusion rates in the early and late postmenopausal groups were consistently lower than those in the premenopausal group during the follow-up period. All patients had satisfactory outcomes at the final follow-up.

Conclusion
There were no significant differences in clinical or other related outcomes of single-level or consecutive two-level ACDF in the long term among female patients with different menopausal statuses. However, the early bony fusion rates and anterior FSU height loss rates were poorer in late postmenopausal patients than in premenopausal or early postmenopausal patients. Hence, importance should be attached to the protection of late postmenopausal patients in the early postoperative period to guarantee solid bony fusion.
Mediterranean diet in axial spondyloarthritis: an observational study in an Italian monocentric cohort
Authors: Ometto Francesca , Ortolan Augusta , Farber Davide , Lorenzin Mariagrazia , Dellamaria Giulia , Cozzi Giacomo , Favero Marta , Valentini Romina , Doria Andrea , Ramonda Roberta 
Published: August 2021

AbstractBackgroundLittle evidence is available about the impact of diet on disease activity of axial spondyloarthritis (axSpA). This study evaluated the impact of a 6-month nutritional advice based on the Mediterranean diet on the disease activity of axSpA.MethodsWe prospectively collected the information of a group of axSpA patients who were offered nutritional advice for a 6-month period, who were compared to axSpA patients followed at the same center who were not on a specific diet. A nutritionist gave suggestions for dietary modification at baseline and thereafter every 2 months until month 6. Adherence to the Mediterranean diet was evaluated with the PREDIMED questionnaire ranging from 0 (no adherence) to 10 (optimal adherence); disease activity was evaluated with ASDAS-CRP. A multivariable regression analysis was conducted to identify independent predictors of PREDIMED and of ASDAS-CRP improvement (improvement ≥ 20% of each score).ResultsA total of 161 patients were included: 81 receiving nutritional advice and 80 controls; 47 in the nutritional group and 63 controls had complete information until month 6. Overall, 40 (36.4%) were females, the mean age was 51.7 ± 1.3 years, and 58 (52.7%) were affected with psoriasis. No relevant change of anthropometric or laboratory measures was observed in either group. Adherence to the Mediterranean diet was moderate (PREDIMED score 6.7 ± 1.8 at baseline; 7.6 ± 2.1 at month 6) and improved more in the nutritional group compared to controls (p= 0.020). Predictors of a PREDIMED improvement ≥ 20% were receiving nutritional advice (OR 4.53, 1.36–15.1,p= 0.014), age (per 10-year increase OR 1.05, 1.02–1.68,p= 0.007), and BMI (OR 0.77, 0.63–0.9,p= 0.006). An ASDAS-CRP improvement ≥ 20% was more frequent in the nutritional group compared to controls (p= 0.020). A PREDIMED improvement ≥ 20% was associated with a ASDAS-CRP improvement ≥ 20% (OR 6.75,1.8–25.3,p= 0.005). Psoriasis and disease duration were negatively but not significantly associated to the ASDAS-CRP improvement.ConclusionsImproving adherence to the Mediterranean diet may have a beneficial impact on the activity of axSpA. Patients with a lower BMI and older patients are more prone to modify their diet towards the Mediterranean diet following nutritional advice. Patients with psoriasis may have a limited benefit from dietary improvement.Study registrationProtocol No. 52723, Padova Hospital Medical Ethical Committee (October 11, 2010).
Axillary lymphadenopathy at the time of COVID-19 vaccination: ten recommendations from the European Society of Breast Imaging (EUSOBI)
Authors: Schiaffino Simone , Pinker Katja , Magni Veronica , Cozzi Andrea , Athanasiou Alexandra , Baltzer Pascal A. T. , Camps Herrero Julia , Clauser Paola , Fallenberg Eva M. , Forrai Gábor , Fuchsjäger Michael H. , Helbich Thomas H. , Kilburn-Toppin Fleur , Kuhl Christiane K. , Lesaru Mihai , Mann Ritse M. , Panizza Pietro , Pediconi Federica , Pijnappel Ruud M. , Sella Tamar , Thomassin-Naggara Isabelle , Zackrisson Sophia , Gilbert Fiona J. , Sardanelli Francesco 
Published: August 2021

AbstractUnilateral axillary lymphadenopathy is a frequent mild side effect of COVID-19 vaccination. European Society of Breast Imaging (EUSOBI) proposes ten recommendations to standardise its management and reduce unnecessary additional imaging and invasive procedures: (1) in patients with previous history of breast cancer, vaccination should be performed in the contralateral arm or in the thigh; (2) collect vaccination data for all patients referred to breast imaging services, including patients undergoing breast cancer staging and follow-up imaging examinations; (3) perform breast imaging examinations preferentially before vaccination or at least 12 weeks after the last vaccine dose; (4) in patients with newly diagnosed breast cancer, apply standard imaging protocols regardless of vaccination status; (5) in any case of symptomatic or imaging-detected axillary lymphadenopathy before vaccination or at least 12 weeks after, examine with appropriate imaging the contralateral axilla and both breasts to exclude malignancy; (6) in case of axillary lymphadenopathy contralateral to the vaccination side, perform standard work-up; (7) in patients without breast cancer history and no suspicious breast imaging findings, lymphadenopathy only ipsilateral to the vaccination side within 12 weeks after vaccination can be considered benign or probably-benign, depending on clinical context; (8) in patients without breast cancer history, post-vaccination lymphadenopathy coupled with suspicious breast finding requires standard work-up, including biopsy when appropriate; (9) in patients with breast cancer history, interpret and manage post-vaccination lymphadenopathy considering the timeframe from vaccination and overall nodal metastatic risk; (10) complex or unclear cases should be managed by the multidisciplinary team.