bluuebunny/crossref_metadata_2025_split huggingface dataset:
An application of PRECIS-2 to evaluate trial design in a pilot cluster randomised controlled trial of a community-based smoking cessation intervention for women living in disadvantaged areas of Ireland
Authors: Darker Catherine , Loudon Kirsty , O’Connell Nicola , Castello Stefania , Burke Emma , Vance Joanne , Reynolds Caitriona , Buggy Aine , Dougall Nadine , Williams Pauline , Dobbie Fiona , Bauld Linda , Hayes Catherine B. 
Published: January 2022

Abstract
Background
“We Can Quit2” (WCQ2) was a pilot cluster randomised controlled trial with an embedded process evaluation assessing the feasibility and acceptability of ‘We Can Quit’ (WCQ, a peer-delivered community-based stop-smoking programme for women in disadvantaged communities. The control group comprised ‘enhanced usual care’ offered by the Irish Health Service Executive (HSE). The PRagmatic Explanatory Continuum Indicator Summary (PRECIS-2) is a tool to assess whether a trial design is more explanatory (working under ideal conditions) or pragmatic (working under ‘real-world’ conditions). The aim of this paper was to retrospectively evaluate the WCQ2 pilot trial using PRECIS-2 to inform the decision-making process on progression to a future definitive trial (DT).

Methods
The WCQ2 trial protocol and HSE standard stop-smoking service were described across the nine PRECIS-2 domains: eligibility, recruitment, setting, organisation, flexibility-delivery, flexibility-adherence, follow-up and primary outcome. Team members scored the domains as pragmatic or explanatory for each arm in a half-day workshop.

Results
Seven team members (practitioners and researchers) assessed the overall trial design as more explanatory than pragmatic. Important differences emerged between the two arms. WCQ targeted adult women from disadvantaged communities whereas HSE run a limited enhanced service for all quitters. Trial recruitment was challenging, intense efforts were needed as the trial proceeded. WCQ was delivered in a non-clinical community setting, HSE services in a clinical setting. WCQ organisation was co-designed with community partners and comprises peer-to-peer group support delivered by trained lay community facilitators, whereas HSE one-to-one support is delivered by Smoking Cessation Officers with a clinical background. Only WCQ allowed flexibility in delivery and adherence. Follow-up was more intensive in WCQ. Greater efforts to improve participant retention will be required in a future DT.

Conclusions
PRECIS-2 allowed the reflection of practitioners and researchers on similarities and differences between intervention and control arms. Results will inform the decision on progression to an effectiveness DT, which will require more a pragmatic and less explanatory design. This novel use of PRECIS-2 to retrospectively evaluate a complex community-based pilot trial in advance of a full DT will also support learning for those undertaking hybrid trials of implementation and effectiveness.

Trial registration
This trial is registered with the ISRCTN registry (No. 74721694).
Efficacy of point-of-care thromboelastography 6s to evaluate platelet function in a patient with pseudothrombocytopenia undergoing cardiopulmonary bypass: a case report
Authors: Chiba Yoshihiko , Otsuka Yuji , Lefor Alan Kawarai , Sanui Masamitsu 
Published: January 2022

Abstract
Background
Pseudothrombocytopenia is a phenomenon caused by in vitro platelet aggregation induced by anticoagulants contained in blood sampling tubes. Thromboelastography (TEG) 6s is a common point-of-care viscoelastic test to assess intraoperative coagulation status, which may reduce the need for blood transfusions. The reliability and usefulness of TEG6s for patients with pseudothrombocytopenia has not been established.

Case presentation
We present a patient with pseudothrombocytopenia, who underwent suprarenal abdominal aortic aneurysm repair under cardiopulmonary bypass. At the beginning of surgery, TEG6s with citrated blood sampling showed that the results were unaffected by the disease. After completion of the aortic repair and the administration of protamine, maximum amplitude of TEG6s and adequate hemostasis were achieved without platelet transfusions, while standard laboratory tests showed thrombocytopenia.

Conclusions
In the present patient who underwent cardiopulmonary bypass, TEG6s may have contributed to a reliable and useful assessment of coagulation and hemostatic status avoiding unnecessary platelet transfusions.
Acquired hemophilia A (AHA): underreported, underdiagnosed, undertreated medical condition
Authors: El Demerdash Doaa M. , Ayad Alia , Tawfik Noha 
Published: January 2022

Abstract
Background
Acquired hemophilia A (AHA) is a rare acquired bleeding disorder occurred due to the formation of inhibitory antibodies neutralizing endogenous factor VIII.

Main body
About half the cases are idiopathic. Symptoms include severe and unexpected bleeding that could be life-threatening. High index of suspicion should be raised when unexplained subcutaneous or post-surgical bleeding with isolated prolonged APTT.

Conclusions
Acquired hemophilia A is a rare underdiagnosed underreported acquired hemostatic disorder that presents with sudden usually life-threatening bleeding; it is crucial to raise awareness and suspicion index of clinicians for early diagnosis and treatment to avoid morbidity and mortality.
A comparative study between rheumatoid arthritis and osteoarthritis regarding association of insomnia with disease status
Authors: Fawzy Rasha M. , Abdel-Monem Samia M. , El-Brashi Abdel-Wahab S. , Mohamed Asmaa A. 
Published: January 2022

Abstract
Background
Sleep disturbance is closely related to inflammation and pain. Good sleep quality is essential for patients’ psychological and physical states as well as their quality of life. The aim of this study was to detect how insomnia as a major sleep disturbance could add to the disease burden in rheumatoid arthritis (RA) and osteoarthritis patients (OA) and to determine the predictor parameters in each of them in order to orient the rheumatologist to this unnoticed symptom that could adversely affect the patients’ life. This study included: 20 RA patients, 20 primary knee OA patients together with 20 healthy controls. RA disease activity was assessed by the disease activity score (DAS-28). All participants were assessed for sleep disturbances by the Athens Insomnia Scale, quality of life (QoL) using the short form QoL (SF-36 QoL) scale, depression by the Beck depression inventory (BDI), and functional disability by the Health Assessment Questionnaire Disability Index (HAQ-DI). OA patients were assessed by the Knee OA Flare Up Score (KOFUS) and the Western Ontario and McMaster Universities Arthritis Index (WOMAC). Radiological evaluation for RA patients was done by the Simple Erosion Narrowing Score, while the Kellgren and Lawrence (K-L) radiological grading system was used for OA patients.

Results
Insomnia was found in 75% of the studied RA patients, 25% of the studied OA patients and none of the healthy control with significant difference (P < 0.001). Significant correlations of the insomnia scale with the number of tender and swollen joints (r = 0.66, 0.76 respectively and p = 0.001 both), DAS-28 (r = 0.71, P < 0.001), anti-CCP antibodies titre (r = 0.53, p = 0.02) and the BDI (r = 0.65, p = 0.002) among RA patients were found. Correlations among OA patients occurred with morning stiffness duration (r = 0.69, P = 0.001), number of affected joints (r = 0.81, P = 0.001), the BDI scale (r = 0.51, P = 0.02), the WOMAC index (r = 0.57, P = 0.009), the KOFUS score (r = 0.76, p < 0.001) and the K-L score (r = 0.67, P = 0.001). Linear regression analysis indicated that the predictors for insomnia in RA were DAS-28 and the BDI, while in OA were the number of affected joints and the KOFUS score.

Conclusions
Insomnia is a disease burden especially in RA patients being one of the leading causes of depression and is greatly affected by the disease activity. In general the burden of insomnia is much less in OA except in severe cases with markedly affected joints. Rheumatologists should be aware of this disorder that could affect patients’ health, mood, and functional activity.
Impact of bariatric surgery on depression, anxiety and stress symptoms among patients with morbid obesity: international multicentre study in Poland and Germany
Authors: Paczkowska Anna , Hoffmann Karolina , Raakow Jonas , Pross Matthias , Berghaus Rafael , Michalak Michał , Bryl Wiesław , Marzec Kinga , Kopciuch Dorota , Zaprutko Tomasz , Ratajczak Piotr , Nowakowska Elżbieta , Kus Krzysztof 
Published: January 2022

Background
There is a need to investigate how adopting different strategies for treating obesity in different countries in the European Union affects the psychological well-being of patients.

Aims
The aim of this study was to perform a comparative evaluation of psychiatric symptoms (depression, anxiety and stress) in patients undergoing bariatric surgery versus patients receiving conservative treatment for morbid obesity in Poland and Germany.

Method
A multicentre international prospective cohort study with 155 patients who underwent bariatric surgery and 409 patients who received conservative weight reduction treatment. Evaluation of the psychiatric symptoms was carried out for each patient at baseline and after 12 months of active treatment using a standardised Depression Anxiety Stress Scale questionnaire (DASS-21) questionnaire.

Results
After 12 months of active treatment, the level of psychiatric symptoms (depression, anxiety and stress) significantly decreased in both groups of patients: surgically treated versus conservatively treated patients from Poland and also from Germany. The median change in level of psychiatric symptoms among patients from both countries was significantly higher among surgically treated patients compared with conservatively treated patients (Poland P < 0.0001; Germany P < 0.0001). Improvements in the patient's mental health as a consequence of treatment were dependent on the specific strategy for treating obesity adopted in the analysed countries, the percentage of total weight loss and on gender.

Conclusions
The use of bariatric surgery in both Poland and Germany compared with non-surgical treatment for obesity resulted in more measurable benefits in the form of a decrease in psychiatric symptoms (depression, anxiety and stress) and reduction in body weight.
Prospective Surveillance for Breast Cancer–Related Arm Lymphedema: A Systematic Review and Meta-Analysis
Authors: Rafn Bolette S. , Christensen Jan , Larsen Anders , Bloomquist Kira 
Published: January 2022

PURPOSE The call to integrate prospective surveillance for lymphedema into cancer care pathways is building momentum to enable early intervention and prevent the progression of the condition. We offer a critical evaluation of the literature on prospective surveillance and early management for cancer-related lymphedema and evaluate the effect of such programs in preventing chronic lymphedema (CRD42019137965). METHODS Five databases and two registries were searched for randomized controlled trials or observational studies that assessed the incidence or prevalence of lymphedema associated with participation in a prospective surveillance program, published until February 26, 2021. Numbers triggered for early lymphedema management, resolved, and chronic lymphedema were extracted. Pooled relative risk (trials) and pooled rate (cumulative incidence; observational studies) of chronic lymphedema was calculated. Subgroup analyses assessed the effect of study design, length of follow-up, and extent of axillary surgery. RESULTS Twenty-three studies were included, of which 21 studies evaluated breast cancer–related arm lymphedema (BCRaL). Participation in prospective surveillance with early management reduced the risk of chronic BCRaL versus usual care (relative risk 0.31; 95% CI, 0.10 to 0.95; two randomized controlled trials; N = 106). The pooled rate of chronic BCRaL was 4% (95% CI, 3 to 6; 15 observational studies; N = 3,545), and 6% (95% CI, 4 to 9) when restricted to participants with axillary lymph node dissection (12 studies; N = 1,527). CONCLUSION The findings suggest that participation in prospective surveillance with early management reduces the risk of chronic BCRaL. Only a minority of patients at high risk of lymphedema because of axillary surgery developed chronic lymphedema. More robust research is needed to determine whether prospective surveillance with early management can reduce the risk of chronic lymphedema, particularly among cancer survivors other than breast cancer.
Can temperature-dependent changes in myocardial contractility explain why fish only increase heart rate when exposed to acute warming?
Authors: Gamperl A. Kurt , Thomas Alexander L. , Syme Douglas A. 
Published: January 2022

ABSTRACT
Fish increase heart rate (fH), not stroke volume (VS), when acutely warmed as a way to increase cardiac output (Q). To assess whether aspects of myocardial function may have some basis in determining temperature-dependent cardiac performance, we measured work and power (shortening, lengthening and net) in isolated segments of steelhead trout (Oncorhynchus mykiss) ventricular muscle at the fish's acclimation temperature (14°C), and at 22°C, when subjected to increased rates of contraction (30–105 min−1, emulating increased fH) and strain amplitude (8–14%, mimicking increased VS). At 22°C, shortening power (indicative of Q) increased in proportion to fH, and the work required to re-lengthen (stretch) the myocardium (fill the heart) was largely independent of fH. In contrast, the increase in shortening power was less than proportional when strain was augmented, and lengthening work approximately doubled when strain was increased. Thus, the derived relationships between fH, strain and myocardial shortening power and lengthening work, suggest that increasing fH would be preferable as a mechanism to increase Q at high temperatures, or in fact may be an unavoidable response given constraints on muscle mechanics as temperatures rise. Interestingly, at 14°C, lengthening work increased substantially at higher fH, and the duration of lengthening (i.e. diastole) became severely constrained when fH was increased. These data suggest that myocardial contraction/twitch kinetics greatly constrain maximal fH at cool temperatures, and may underlie observations that fish elevate VS to an equal or greater extent than fH to meet demands for increased Q at lower temperatures.
Parental coronavirus disease vaccine hesitancy for children in Bangladesh: a cross-sectional study
Authors: Ali Mohammad , Ahmed Sohel , Bonna Atia Sharmin , Sarkar Abu-sufian , Islam Md. Ariful , Urmi Tania Akter , Proma Tasnuva Samarukh 
Published: January 2022

Background: Coronavirus disease 2019 (COVID-19) requires mass immunization to control the symptoms and global spread of severe acute respiratory syndrome coronavirus 2. Data from developed countries reported a high prevalence of parental COVID-19 vaccine hesitancy. However, parental vaccine hesitancy data in countries with low and middle income are scarce. The goal of this study was to assess the prevalence of parental vaccine hesitancy and identify subgroups with higher odds of vaccine hesitancy. Methods: A cross-sectional study was conducted on parents of children aged <18 years from October 10, 2021, to October 31, 2021. Parents aged ≥18 years underwent face-to-face interviews in randomly selected places in Bangladesh using a vaccine hesitancy questionnaire. Predictors were identified using binary logistic regression analysis. Results: Data from 2633 eligible parents were analyzed. Overall, 42.8% reported COVID-19 vaccine hesitancy for their youngest child. The final model suggested that children's age, parent's age, religion, occupation, monthly household income, permanent address, living location, the status of tobacco use, adherence with the regular government vaccination programs (other than COVID-19), perception about COVID-19 vaccine efficacy among Bangladeshi children, self-vaccination intention, report about family members' illness or death from COVID-19, and perceived COVID-19 threat were the independent predictors of parental vaccine hesitancy. Conclusions: Vaccine hesitation varied based on sociodemographic characteristics, religion, behavior, and perceived COVID-19 threat. Therefore, interventions focused on addressing vaccine hesitancy among subgroups are warranted.
An Interior-Point Differentiable Path-Following Method to Compute Stationary Equilibria in Stochastic Games
Authors: Dang Chuangyin , Herings P. Jean-Jacques , Li Peixuan 
Published: January 2022

The subgame perfect equilibrium in stationary strategies (SSPE) is the most important solution concept in applications of stochastic games, making it imperative to develop efficient methods to compute an SSPE. For this purpose, this paper develops an interior-point differentiable path-following method (IPM), which establishes a connection between an artificial logarithmic barrier game and the stochastic game of interest by adding a homotopy variable. IPM brings several advantages over the existing methods for stochastic games. On the one hand, IPM provides a bridge between differentiable path-following methods and interior-point methods and remedies several issues of an existing homotopy method called the stochastic linear tracing procedure (SLTP). First, the starting stationary strategy profile can be arbitrarily chosen. Second, IPM does not need switching between different systems of equations. Third, the use of a perturbation term makes IPM applicable to all stochastic games rather than generic games only. Moreover, a well-chosen transformation of variables reduces the number of equations and variables by roughly one half. Numerical results show that the proposed method is more than three times as efficient as SLTP. On the other hand, the stochastic game can be reformulated as a mixed complementarity problem and solved by the PATH solver. We employ the proposed IPM and the PATH solver to compute SSPEs. Numerical results evince that for some stochastic games the PATH solver may fail to find an SSPE, whereas IPM is successful in doing so for all stochastic games, which confirms the reliability and stability of the proposed method. Summary of Contribution: This paper incorporates the interior-point methods into a differentiable path-following method for computing stationary equilibria for stochastic games. This novel method brings excellent computational advantages and remedies several issues with the existing methods for stochastic games. We prove the global convergence of the proposed method and employ this method to solve numerous randomly generated stochastic games with different scales. Numerical results further confirm the high efficiency, stability, and universality of this method for stochastic games.
Information Leakage Around SEC Comment Letters
Authors: Geiger Marshall A. , Johnson Bret , Jones Keith L. , Kumas Abdullah 
Published: January 2022

We investigate whether sophisticated investors obtain information about Securities and Exchange Commission (SEC) comment letters before the public release date. Specifically, we examine mutual fund trading behavior around dates firms receive a comment letter. We find significant abnormal net selling by mutual funds immediately after a firm receives a comment letter. Additional tests find that abnormal net selling is greater when firms receive a second-round letter, where information leakage is more likely (e.g., firms with high board member connectedness and higher dedicated institutional ownership) and when comment letters address more critical issues (e.g., the need to restate prior results or related party transactions). We also find that funds with high abnormal net selling in the private phase avoid significant future share price declines. In sum, we find consistent evidence that mutual funds appear to trade on information obtained during the private phase of the SEC comment letter process. This paper was accepted by Brian Bushee, accounting. Supplemental Material: Data are available at https://doi.org/10.1287/mnsc.2021.4259 .
Data-Induced Rationality and Unitary Spaces in Interfirm Collaboration
Authors: Cepa Katharina , Schildt Henri 
Published: January 2022

The real-time data transfer between collaborating companies allows them to represent and control activities across firm boundaries, providing new ways to organize collaborative efforts. We conducted an inductive multiple case study of five long-term relationships to examine the effects of data-intensive technologies on the organization and management of collaborative relationships in industrial companies. Our analysis shows how the delegation of digital activities into specialized digital units fostered data-driven mindsets and data-driven interactions that jointly formed a holistic data-induced rationality for managing the relationship. Together, the compartmentalization of digital collaboration and the data-induced rationalities turned these units into “unitary spaces,” organizational enclosures where structural tensions and competing demands were temporarily suspended to foster single-minded pursuit of collaborative short-term benefits for the partner company. Funding: The authors are grateful for the financial support from the Academy of Finland [Grant 274536].
Negative pressure wound therapy, artificial skin and autogenous skin implantation in diabetic foot ulcers
Authors: Chia-Jui Hu , Yu Lai , Jiang Yu-qing , Tan Wen , Gao Gong-ming , Li Hai-bo , Han Long 
Published: January 2022

Objective:Diabetic foot ulcers (DFUs) are one of the most serious diabetic consequences, leading to amputations. Various therapies have been used to treat DFUs; however, a combination of negative pressure suction, artificial skin and autogenous skin implantation have never been investigated. This study aimed to evaluate the effectiveness of a novel three-step therapy protocol using negative pressure wound therapy (NPWT), artificial skin and autogenous skin implantation in patients with DFUs.Method:At a single tertiary university hospital between 2015 and 2018, the three-step therapy protocol was applied to patients with DFUs and its safety and efficacy was investigated.Results:A total of 21 patients took part in the study. The majority of the patients were female (62%), with a mean age of 65 years and a mean body mass index of 21kg/m2. A third (n=7) of operative sites experienced minor complications, with two requiring re-operation. At a median follow up of 24 months, the average time of complete wound healing was 46 days, and the wound healing rate was 71%. The first-stage wound healing rate was 90%. All patients had achieved remission without any further recurrence of disease.Conclusion:This comprehensive surgical technique for managing DFUs achieved a high local cure rate, minimal functional morbidity, and acceptable wound complication rates. The three-step therapy protocol has the potential to promote the healing process of DFUs, which is expected to serve as a new method for the treatment and cure of DFUs.