bluuebunny/crossref_metadata_2025_split huggingface dataset:
A Bayesian response-adaptive dose-finding and comparative effectiveness trial
Authors: Heath Anna , Yaskina Maryna , Pechlivanoglou Petros , Rios David , Offringa Martin , Klassen Terry P , Poonai Naveen , Pullenayegum Eleanor 
Published: November 2020

Background/Aims: Combinations of treatments that have already received regulatory approval can offer additional benefit over Each of the treatments individually. However, trials of these combinations are lower priority than those that develop novel therapies, which can restrict funding, timelines and patient availability. This article develops a novel trial design to facilitate the evaluation of New combination therapies. This trial design combines elements of phase II and phase III trials to reduce the burden of evaluating combination therapies, while also maintaining a feasible sample size. This design was developed for a randomised trial that compares the properties of three combination doses of ketamine and dexmedetomidine, given intranasally, to ketamine delivered intravenously for children undergoing a closed reduction for a fracture or dislocation. Methods: This trial design uses response-adaptive randomisation to evaluate different dose combinations and increase the information collected for successful novel drug combinations. The design then uses Bayesian dose-response modelling to undertake a comparative effectiveness analysis for the most successful dose combination against a relevant comparator. We used simulation methods determine the thresholds for adapting the trial and making conclusions. We also used simulations to evaluate the probability of selecting the dose combination with the highest true effectiveness the operating characteristics of the design and its Bayesian predictive power. Results: With 410 participants, five interim updates of the randomisation ratio and a probability of effectiveness of 0.93, 0.88 and 0.83 for the three dose combinations, we have an 83% chance of randomising the largest number of patients to the drug with the highest probability of effectiveness. Based on this adaptive randomisation procedure, the comparative effectiveness analysis has a type I error of less than 5% and a 93% chance of correcting concluding non-inferiority, when the probability of effectiveness for the optimal combination therapy is 0.9. In this case, the trial has a greater than 77% chance of meeting its dual aims of dose-finding and comparative effectiveness. Finally, the Bayesian predictive power of the trial is over 90%. Conclusions: By simultaneously determining the optimal dose and collecting data on the relative effectiveness of an intervention, we can minimise administrative burden and recruitment time for a trial. This will minimise the time required to get effective, safe combination therapies to patients quickly. The proposed trial has high potential to meet the dual study objectives within a feasible overall sample size.
Recruitment and retention in randomized controlled trials with urban American Indian/Alaska Native adolescents: Challenges and lessons learned
Authors: Dickerson Daniel L , Parker Jennifer , Johnson Carrie L , Brown Ryan A , D’Amico Elizabeth J 
Published: November 2020

Background: Although the majority of American Indians/Alaska Natives reside in urban areas, there are very few randomized controlled trials analyzing culturally centered substance use prevention interventions for this population. Methods: We describe methods employed to recruit and retain urban American Indian/Alaska Native adolescents into a randomized controlled trial, which was focused on testing the potential benefits of a substance use prevention intervention for this population. We also report challenges encountered in recruitment and retention of participants and strategies employed addressing these challenges. Data collection occurred from August 2014 to October 2017. Results: We partnered with two community-based organizations in different cities in California. We utilized American Indian/Alaska Native recruiters from communities, placed flyers in community-based organizations, and asked organizations to post flyers on their web and social media sites. We also offered gift cards for participants. Our initial recruitment and retention model was moderately successful; however, we encountered five main challenges: (1) transportation, (2) increasing trust and interest, (3) adding research sites, (4) getting the word out about the project, and (5) getting youth to complete follow-up surveys. Strategies employed to overcome transportation challenges included shortening the number of sessions, offering sessions on both weekends and weekdays, and increasing bus tokens and transportation options. We hired more staff from American Indian/Alaska Native communities, added more research sites from our previously established relationships, and were more proactive in getting the word out on the project in American Indian/Alaska Native communities. We also utilized more field tracking and emailed and mailed survey invitations to reach more participants for their follow-up surveys. Because of our efforts, we were nearly able to reach our initial recruitment and retention goals. Conclusion: Although our research team had previously established relationships with various urban American Indian/Alaska Native communities, we encountered various recruitment and retention challenges in our study. However, by identifying challenges and employing culturally appropriate strategies, we were able to collect valuable data on the potential effectiveness of a substance use prevention intervention for urban American Indian/Alaska Native adolescents. Findings from this study assist toward the development of potentially successful strategies to successfully recruit and retain urban American Indian/Alaska Native adolescents in randomized controlled trials.
Breastfeeding attitudes of refugee women from Syria and influencing factors: a study based on the transition theory
Authors: Ozkaya Meltem , Korukcu Oznur , Aune Ingvild 
Published: November 2020

Aims: This review was designed to systematically examine studies that determine the breastfeeding attitudes of Syrian mothers, and factors influencing their breastfeeding behavior. Methods: Studies published between 2010 and 2020 were examined using ‘Syria OR Syrian mother OR Syrian refugee AND breastfeeding OR breastfeeding practices OR intention OR attitudes OR exclusive breastfeeding’ as keywords on PubMed, GoogleScholar, MEDLINE, Scopus, ProQuest, National Thesis Center, Web of Science, ScienceDirect and CINAHL; and five publications meeting the inclusion criteria were included in the study. The researchers independently used JBI Critical Appraisal Checklist for Analytical Cross-Sectional Studies and JBI Critical Appraisal Checklist for Systematic Reviews and Research Syntheses, developed by Joanna Briggs Institute, to assess the methodological quality. Results: A total of 6546 studies were accessed as a result of the literature review. Five studies meeting the inclusion criteria were included in the study. Women who are in this process experience a developmental and situational transition according to the framework of Meleis’ theory. Factors affecting their breastfeeding attitudes were grouped under three main and four sub-themes. It was determined that personal factors (socioeconomic factors, cultural beliefs, the significance of breastfeeding practice, preparation), factors related to the immediate environment and social factors affect these women’s attitudes toward breastfeeding. Conclusion: It was found that most of the Syrian women had positive attitudes toward breastfeeding; however, the breastfeeding duration was less than 6 months for most of the refugees. Furthermore, according to the results of the studies, refugee women from Syria who did not receive social support from their spouses and relatives stopped breastfeeding.
The run-in phase of the prospective WSG-ADAPT HR+/HER2– trial demonstrates the feasibility of a study design combining static and dynamic biomarker assessments for individualized therapy in early breast cancer
Authors: Nitz Ulrike , Gluz Oleg , Kreipe Hans H. , Christgen Matthias , Kuemmel Sherko , Baehner Frederick L. , Shak Steven , Aktas Bahriye , Braun Michael , Lüdtke-Heckenkamp Kerstin , Forstbauer Helmut , Grischke Eva-Maria , Nuding Benno , Darsow Maren , Schumacher Claudia , Krauss Katja , Malter Wolfram , Thill Marc , Warm Mathias , Wuerstlein Rachel , Kates Ronald E. , Harbeck Nadia 
Published: November 2020

Background: Endocrine sensitivity, as determined by response of the proliferation marker Ki-67 to short-term preoperative endocrine therapy (ET), is currently not included in adjuvant treatment decisions in hormone receptor (HR)+/human epidermal growth factor receptor 2 (HER2)− breast cancer (BC). Methods: The prospective WSG-ADAPT HR+/HER2− trial included patients with N0/N1 early BC who were candidates for adjuvant chemotherapy based on clinical–pathological criteria alone. The trial utilized a genomic assessment [the Recurrence Score (RS)] plus endocrine sensitivity testing to guide treatment. All patients received 3 (±1) weeks of preoperative induction ET. According to protocol, patients with RS 0–11 or RS 12–25 plus endocrine proliferation response (EPR, post-induction Ki-67 ⩽ 10%) were to be spared adjuvant chemotherapy. Results: The ADAPT HR+/HER2− trial run-in phase included 407 patients with baseline RS, of whom 386 (median age: 54 years) had complete data for Ki-67 at both baseline and post-induction. RS distribution: 23.1% RS 0–11, 58.3% RS 12–25, and 18.7% RS 26–100. EPR occurred in 84.3%, 76.0%, and 36.1% of these RS groups, respectively. Differences in EPR proportions (RS 26–100 versus others, RS 0–11 versus others) were significant (both p < 0.001); Ki-67 quotients were higher for RS 26–100 ( p = 0.02, Mann–Whitney). In premenopausal women ( n = 146, mostly tamoxifen-treated), median quotient of Ki-67 level (post/pre) was significantly higher than in postmenopausal women ( n = 222, mostly aromatase-inhibitor treated; 0.67 versus 0.25, p < 0.001). EPR was significantly associated with baseline estrogen-receptor status as determined by immunohistochemistry ( p = 0.002) or real-time polymerase chain reaction ( p < 0.001). Also, a strong correlation was observed between RS measured pre- and post-ET (RS = 0.7, n = 181). Conclusions: This phase of the WSG-ADAPT HR+/HER2− trial confirms trial design estimates of RS and EPR. It indicates that the ADAPT concept of combining static and dynamic biomarker assessment for individualized therapy decisions in early BC is feasible using the EPR criterion post-induction Ki-67 ⩽ 10%. Clinicaltrials.gov identifier: NCT01779206.
Sequential changes in lower extremity function after total knee arthroplasty
Authors: Tsubosaka Masanori , Muratsu Hirotsugu , Nakano Naoki , Kamenaga Tomoyuki , Kuroda Yuichi , Miya Hidetoshi , Kuroda Ryosuke , Matsumoto Tomoyuki 
Published: November 2020

Purpose: The effectiveness of total knee arthroplasty (TKA) for recovering ambulation and balance functions has not been investigated in detail. The present study aimed to measure functional changes in the lower limb before and after TKA by measuring ambulation function with the 3 m Timed Up and Go (TUG) test and balance function using one-leg standing time (ST). Methods: The study included 137 patients (116 women and 21 men) with osteoarthritis of the knee who underwent primary TKA. The mean age of the patients was 74.4 years. The mean postoperative hospital stay for rehabilitation was 23.9 days. The TUG test and ST were performed preoperatively, 2 weeks postoperatively, at discharge, and 3, 6, and 12 months postoperatively. These results from these six measurements were also compared using one-way repeated measures analysis of variance. Results: The TUG test and ST were significantly improved at 3 months after surgery. However, both the TUG test and ST did not improve further from 3 months to 6 months postoperatively or from 6 months to 1 year postoperatively. Conclusion: TKA is useful for restoring lower limb function, as both ambulation and balance functions were significantly improved 3 months after surgery. However, no further improvement in ambulation or balance function was recognized beyond 3 months.
Impacts on Surgery Resident Education at a First Wave COVID-19 Epicenter
Authors: Ostapenko Alexander , McPeck Samantha , Liechty Shawn , Kleiner Daniel 
Published: November 2020

Purpose: This study aims to identify the effects of the COVID-19 pandemic on surgical resident training and education at Danbury Hospital. Methods: We conducted an observational study at a Western Connecticut hospital heavily affected by the first wave of the COVID-19 pandemic to assess its effects on surgical residents, focusing on surgical education, clinical experience, and operative skills development. Objective data was available through recorded work hours, case logs, and formal didactics. In addition, we created an anonymous survey to assess resident perception of their residency experience during the pandemic. Results: There are 22 surgical residents at our institution; all were included in the study. Resident weekly duty hours decreased by 23.9 hours with the majority of clinical time redirected to caring for COVID-19 patients. Independent studying increased by 1.6 hours (26.2%) while weekly didactics decreased by 2.1 hours (35.6%). The operative volume per resident decreased by 65.7% from 35.0 to 12.0 cases for the period of interest, with a disproportionately high effect on junior residents, who experienced a 76.2% decrease. Unsurprisingly, 70% of residents reported a negative effect of the pandemic on their surgical skills. Conclusions: During the first wave of the COVID-19 pandemic, surgical residents’ usual workflows changed dramatically, as much of their time was dedicated to the critical care of patients with COVID-19. However, the consequent opportunity cost was to surgery-specific training; there was a significant decrease in operative cases and time spent in surgical didactics, along with elevated concern about overall preparedness for their intended career.
Association between serum lactate levels and mortality in patients with cardiogenic shock receiving mechanical circulatory support: a multicenter retrospective cohort study
Authors: Scolari Fernando Luís , Schneider Daniel , Fogazzi Débora Vacaro , Gus Miguel , Rover Marciane Maria , Bonatto Marcely Gimenes , de Araújo Gustavo Neves , Zimerman André , Sganzerla Daniel , Goldraich Lívia Adams , Teixeira Cassiano , Friedman Gilberto , Polanczyk Carisi Anne , Rohde Luis Eduardo , Rosa Regis Goulart , Wainstein Rodrigo Vugman 
Published: November 2020

AbstractBackgroundTo evaluate the prognostic value of peak serum lactate and lactate clearance at several time points in cardiogenic shock treated with temporary mechanical circulatory support (MCS) using veno-arterial extracorporeal membrane oxygenation (VA-ECMO) or Impella CP®.MethodsSerum lactate and clearance were measured before MCS and at 1 h, 6 h, 12 h, and 24 h post-MCS in 43 patients at four tertiary-care centers in Southern Brazil. Prognostic value was assessed by univariable and multivariable analysis and receiver operating characteristic (ROC) curves for 30-day mortality.ResultsVA-ECMO was the most common MCS modality (58%). Serum lactate levels at all time points and lactate clearance after 6 h were associated with mortality on unadjusted and adjusted analyses. Lactate levels were higher in non-survivors at 6 h, 12 h, and 24 h after MCS. Serum lactate > 1.55 mmol/L at 24 h was the best single prognostic marker of 30-day mortality [area under the ROC curve = 0.81 (0.67–0.94); positive predictive value = 86%). Failure to improve serum lactate after 24 h was associated with 100% mortality.ConclusionsSerum lactate was an important prognostic biomarker in cardiogenic shock treated with temporary MCS. Serum lactate and lactate clearance at 24 h were the strongest independent predictors of short-term survival.
Digital consultations in Swedish primary health care: a qualitative study of physicians’ job control, demand and support
Authors: Fernemark Hanna , Skagerström Janna , Seing Ida , Ericsson Carin , Nilsen Per 
Published: November 2020

Abstract
Background
Digital consultation with primary care physicians via mobile telephone apps has been spreading rapidly in Sweden since 2014. Digital consultation allows remote working because physicians can work from home, outside their traditional primary care environment. Despite the spread of digital consultation in primary care, there is a lack of knowledge concerning how the new service affects physicians’ psychosocial work environment. Previous research has focused primarily on the patients’ point of view and the cost-effectiveness of digital consultation. Hence, there is a paucity of studies from the perspective of physicians, focusing on their psychosocial work environment. The aim of this study was to investigate primary care physicians’ perceived work demands, control over working processes, and social support when providing digital consultation to primary care patients.

Methods
The study has a qualitative design, using semi-structured interviews conducted in Sweden in 2019. We used a purposeful sampling strategy to achieve a heterogeneous sample of physicians who represented a broad spectrum of experiences and perceptions. The interviews were conducted by video meeting, telephone, or a personal meeting, depending on what suited the participant best. The interview questions were informed by the Job Demand-Control-Support (JDCS) model, which was also used as the framework to analyze the data by categorizing the physicians’ perceptions and experiences into the three categories of the model (Demand, Control, Support), in the deductive analysis of the data.

Results
Analysis of the data yielded 9 subcategories, which were mapped onto the 3 categories of the JDCS model. Overall, the participants saw numerous benefits with digital consultations, not only with regard to their own job situation but also for patients and the health care system in general even though they identified some shortcomings and risks with digital care.

Conclusions
This study has demonstrated that physicians perceive working with digital consultation as flexible with a high grade of autonomy and reasonable to low demands. According to the participants, digital consultation is not something you can work with full time if medical skills and abilities are to be maintained and developed.
Can usual gait speed be used as a prognostic factor for early palliative care identification in hospitalized older patients? A prospective study on two different wards
Authors: Van de Vyver Celine , Velghe Anja , Baeyens Hilde , Baeyens Jean-Pierre , Dekoninck Julien , Van Den Noortgate Nele , Piers Ruth 
Published: November 2020

AbstractBackgroundTimely palliative care in frail older persons remains challenging. Scales to identify older patients at risk of functional decline already exist. However, factors to predict short term mortality in older hospitalized patients are scarce.MethodsIn this prospective study, we recruited patients of 75 years and older at the department of cardiology and geriatrics. The usual gait speed measurement closest to discharge was chosen. We used the risk of dying within 1 year as parameter for starting palliative care. ROC curves were used to determine the best cut-off value of usual gait speed to predict one-year mortality. Time to event analyses were assessed by COX regression.ResultsOn the acute geriatric ward (n = 60), patients were older and more frail (assessed by Katz and iADL) in comparison to patients on the cardiology ward (n = 82); one-year mortality was respectively 27 and 15% (p = 0.069). AUC on the acute geriatric ward was 0.748 (p = 0.006). The best cut-off value was 0.42 m/s with a sensitivity and specificity of 0.857 and 0.643. Slow walkers died earlier than faster walkers (HR 7.456,p = 0.011), after correction for age and sex. On the cardiology ward, AUC was 0.560 (p = 0.563); no significant association was found between usual gait speed and survival time.ConclusionsUsual gait speed may be a valuable prognostic factor to identify patients at risk for one-year mortality on the acute geriatric ward but not on the cardiology ward.
Adult case of giant sacrococcygeal teratoma: case report
Authors: Mindaye Esubalew T. , Kassahun Mulugeta , Prager Sarah , Tufa Tesfaye H. 
Published: November 2020

Abstract
Background
Sacrococcygeal teratomas are tumors originating from pluripotent embryonic germ cell layers located in the fetal coccyx. These tumors are highly vascular if they undergo malignant transformation. Typically, they are found in infants and children and occasionally can be diagnosed prenatally. Adult cases are very rare, and represent tumors present since birth with delayed detection.

Case presentation
We describe a case of a giant sacrococcygeal teratoma in a 25 years old female college student presenting with right gluteal swelling of 4 months’ duration. In addition to the huge disfiguring mass on the perineal area, she also had lower abdominal pain, urinary complaints, and difficulty with ambulation.

Discussion
Pre-operative impression was of a sacrococcygeal mass and histopathology following complete surgical excision revealed a sacrococcygeal teratoma. She recovered well after surgery with no radiologic evidence of recurrence at six months.

Conclusion
Although rare, sacrococcygeal teratoma should be considered as a differential diagnosis for female adults presenting with perineal and/or pelvic masses. Complete surgical excision remains the mainstay of treatment.
Parastomal hernia repair with onlay mesh remains a safe and effective approach
Authors: De Robles Marie Shella , Young Christopher J. 
Published: November 2020

Abstract
Background
Parastomal hernia (PSH) management poses difficulties due to significant rates of recurrence and morbidity after repair. This study aims to describe a practical approach for PSH, particularly with onlay mesh repair using a lateral peristomal incision.

Methods
This is a retrospective review of consecutive patients who underwent PSH repair between 2001 and 2018.

Results
Seventy-six consecutive PSH with a mean follow-up of 93.1 months were reviewed. Repair was carried out for end colostomy (40%), end ileostomy (25%), ileal conduit (21%), loop colostomy (6.5%) end-loop colostomy (5%) and loop ileostomy (2.5%). The repair was performed either with a lateral peristomal incision (59%) or a midline incision (41%). Polypropylene mesh (86%), biologic mesh (8%) and composite mesh (6%) were used. Stoma relocation was done in 9 patients (12%). Eight patients (11%) developed postoperative wound complications. Recurrence occurred in 16 patients (21%) with a mean time to recurrence at 29.4 months. No significant difference in wound complication and recurrence was observed based on the type of stoma, incision used, type of mesh used, and whether or not the stoma was repaired on the same site or relocated.

Conclusion
Onlay mesh repair of PSH remains a practical and safe approach and could be an advantageous technique for high-risk patients. It can be performed using a lateral peristomal incision with low morbidity and an acceptable recurrence rate. However, for patients with significant adhesions and very large PSH, a midline approach with stoma relocation may also be considered.