bluuebunny/crossref_metadata_2025_split huggingface dataset:
Prospective, Blinded, Randomized Controlled Trial of Stemless Versus Stemmed Humeral Components in Anatomic Total Shoulder Arthroplasty
Authors: Wiater J. Michael , Levy Jonathan C. , Wright Stephen A. , Brockmeier Stephen F. , Duquin Thomas R. , Wright Jonathan O. , Codd Timothy P. 
Published: September 2020

Background:
Stemless humeral components for anatomic total shoulder arthroplasty (aTSA) have several reported potential benefits compared with stemmed implants. However, we are aware of no Level-I, randomized controlled trials (RCTs) that have compared stemless implants with stemmed implants in patients managed with aTSA. We sought to directly compare the short-term clinical and radiographic outcomes of stemless and stemmed implants to determine if the stemless implant is noninferior to the stemmed implant.

Methods:
We performed a prospective, multicenter, single-blinded RCT comparing stemless and short-stemmed implants in patients managed with aTSA. Range-of-motion measurements and American Shoulder and Elbow Surgeons (ASES), Single Assessment Numeric Evaluation (SANE), and Constant scores were obtained at multiple time points. Device-related complications were recorded. Radiographic evaluation for evidence of loosening, fractures, dislocation, or other component complications was performed. Statistical analysis for noninferiority was performed at 2 years of follow-up for 3 primary end points: ASES score, absence of device-related complications, and radiographic signs of loosening. All other data were compared between cohorts at all time points as secondary measures.

Results:
Two hundred and sixty-five shoulders (including 176 shoulders in male patients and 89 shoulders in female patients) were randomized and received the allocated treatment. The mean age of the patients (and standard deviation) was 62.6 ± 9.3 years, and 99% of the shoulders had a primary diagnosis of osteoarthritis. At 2 years, the mean ASES score was 92.5 ± 14.9 for the stemless cohort and 92.2 ± 13.5 for the stemmed cohort (p value for noninferiority test, <0.0001), the proportion of shoulders without device-related complications was 92% (107 of 116) for the stemless cohort and 93% (114 of 123) for the stemmed cohort (p value for noninferiority test, 0.0063), and no shoulder in either cohort had radiographic signs of loosening. Range-of-motion measurements and ASES, SANE, and Constant scores did not differ significantly between cohorts at any time point within the 2-year follow-up.

Conclusions:
At 2 years of follow-up, the safety and effectiveness of the stemless humeral implant were noninferior to those of the stemmed humeral implant in patients managed with aTSA for the treatment of osteoarthritis. These short-term results are promising given the potential benefits of stemless designs over traditional, stemmed humeral components.

Level of Evidence:
Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.
The Optimal Dosing Regimen for Tranexamic Acid in Revision Total Hip Arthroplasty
Authors: Sershon Robert A. , Fillingham Yale A. , Abdel Matthew P. , Malkani Arthur L. , Schwarzkopf Ran , Padgett Douglas E. , Vail Thomas P. , Nam Denis , Nahhas Cindy , Culvern Chris , Della Valle Craig J. ,   The Hip Society Research Group
Published: September 2020

Background:
The purpose of this multicenter, randomized trial was to determine the optimal dosing regimen of tranexamic acid (TXA) to minimize perioperative blood loss in revision total hip arthroplasty.

Methods:
Six centers prospectively randomized 175 patients to 1 of 4 regimens: (1) 1-g intravenous (IV) TXA prior to incision (the single-dose IV group), (2) 1-g IV TXA prior to incision followed by 1-g IV TXA after arthrotomy wound closure (the double-dose IV group), (3) a combination of 1-g IV TXA prior to incision and 1-g intraoperative topical TXA (the combined IV and topical group), or (4) 3 doses totaling 1,950-mg oral TXA (the multidose oral group). Randomization was based on revision subgroups to ensure equivalent group distribution. An a priori power analysis (α = 0.05; β = 0.80) determined that 40 patients per group were required to identify a >1-g/dL difference in postoperative hemoglobin reduction between groups. Per-protocol analysis involved an analysis of variance, Fisher exact tests, and two 1-sided t tests for equivalence. Demographic and surgical variables were equivalent between groups.

Results:
No significant differences were found between TXA regimens when evaluating reduction in hemoglobin (3.4 g/dL for the single-dose IV group, 3.6 g/dL for the double-dose IV group, 3.5 g/dL for the combined IV and topical group, and 3.4 g/dL for the multidose oral group; p = 0.95), calculated blood loss (p = 0.90), or transfusion rates (14% for the single-dose IV group, 18% for the double-dose IV group, 17% for the combined group, and 17% for the multidose oral group; p = 0.96). Equivalence testing revealed that all possible pairings were statistically equivalent, assuming a >1-g/dL difference in hemoglobin reduction as clinically relevant. There was 1 venous thromboembolism, with no differences found between groups (p = 1.00).

Conclusions:
All 4 TXA groups tested had equivalent blood-sparing properties in the setting of revision total hip arthroplasty, with a single venous thromboembolism reported in this high-risk population. Based on the equivalence between groups, surgeons should utilize whichever of the 4 investigated regimens is best suited for their practice and hospital setting. Given the transfusion rate in revision total hip arthroplasty despite TXA utilization, further work is required in this area.

Level of Evidence:
Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.
Pathomechanisms and Predisposing Factors for Degenerative Lumbar Spondylolisthesis
Authors: Yoshihara Hiroyuki 
Published: September 2020

» The pathomechanism of degenerative lumbar spondylolisthesis (DLS) is not fully understood and is likely to be multifactorial.» The primary cause of DLS likely is age-related degeneration of all of the components of the segments and their surroundings. Subsequently, additional factors, such as anatomical, hormonal, and mechanical stress factors, may drive the spinal segments to DLS.» Reported predisposing factors that have shown a consistent association with DLS include older age, female sex, sagittal facet joint orientation, and high pelvic incidence.» Future prospective epidemiological studies that include large groups of subjects and use multivariate analyses of the possible predisposing factors are needed.
Cost-effectiveness analysis of different methods of treatment of tubal ectopic pregnancy in the south of Iran
Authors: Jahromi Bahia Namavar , esmaili Elahe , Fardid Mozhgan , Abdosaleh Jafari , Kavosi Zahra , Shiravani Zahra , Darab Mohsen Ghaffari , Keshavarz Khosro 
Published: September 2020

Abstract
Background: Ectopic pregnancy is one of the most important causes of maternal mortality and infertility that may impose many costs on patients. Today, Surgery and pharmaceutical treatments are the common methods of treating the disease. The aim of this study was to evaluate the cost-effectiveness of different methods of treating tubal ectopic pregnancy in the south of Iran.Methods: This study was an economic evaluation which analysed and compared the cost-effectiveness and cost-utility of three treatment methods, including single-dose methotrexate, double-dose methotrexate, and surgery in patients with tubal ectopic pregnancy. In this study, a decision tree model was used. The outcomes included in the model were the percentage of successful treatment and the average utility score of each treatment method. The study was conducted from the social perspective and a one-way and probabilistic sensitivity analysis was performed to measure the effects of uncertainty. The analysis of the collected data was performed using Excel and TreeAge software.Results: The incremental cost-effectiveness ratio of the surgery versus single-dose methotrexate was positive and equal to $5812 PPP; since it was less than the threshold, surgery was considered as a cost-effective method. The incremental cost-utility ratio also identified surgery as the best option. Moreover, the results of one-way showed the highest sensitivity to the effectiveness of single-dose methotrexate. Scatter plots also revealed that surgery in 82% and 96% of simulations was at the acceptable region compared with a single dose and double-dose methotrexate, respectively and below the threshold. It was identified as a more cost-effective strategy. Furthermore, the acceptability curves showed that in 81.4% of simulations, surgery was the most cost-effective treatment for thresholds less than 21011 PPP dollars.Conclusions: Based on the results of the present study, it is recommended that surgery can be used as the first line of treatment for ectopic. Also, the best drug strategy was single-dose methotrexate. Since these strategies reduce costs and increase treatment success and QALYs compared to double-dose methotrexate.
Protocol: A Multi-Modal, Physician-Centered Intervention to Improve Guideline-Concordant Prostate Cancer Imaging
Authors: Makarov Danil V , Ciprut Shannon , Kelly Matthew , Walter Dawn , Shedlin Michele G , Braithewaite Ronald Scott , Tenner Craig T , Gold Heather T , Zeliadt Steven , Sherman Scott E 
Published: September 2020

Abstract
Background: Almost half of Veterans with localized prostate cancer receive inappropriate, wasteful staging imaging. Our team has explored the barriers and facilitators of guideline-concordant prostate cancer imaging and found that 1) patients with newly diagnosed prostate cancer have little concern for radiographic staging but rather focus on treatment, 2) physicians trust imaging guidelines but are apt to follow their own intuition, fear medico-legal consequences, and succumb to influence from imaging-avid colleagues. We used a theory-based approach to design a multi-level intervention strategy to promote guideline-concordant imaging to stage incident prostate cancer.Methods: We designed the Prostate Cancer Imaging Stewardship (PCIS) intervention: a multi-site, stepped wedge, cluster-randomized trial to determine the effect of a physician-focused behavioral intervention on Veterans Health Administration (VHA) prostate cancer imaging use. The multi-level intervention, developed according to the Theoretical Domains Framework (TDF) and Behavior Change Wheel, combines traditional physician behavior change methods with novel methods of communication and data collection. The intervention consists of three components: 1) a system of audit and feedback to clinicians informing individual clinicians and their sites about how their behavior compares to their peers’ and to published guidelines 2) a program of academic detailing with the goal to educate providers about prostate cancer imaging, and 3) a CPRS Clinical Order Check for potentially guideline-discordant imaging orders. The intervention will be introduced to 10 participating geographically-distributed study sites.Discussion: This study is a significant contribution to implementation science, providing VHA an opportunity to ensure delivery of high-quality care at the lowest cost using a theory-based approach. The study is ongoing. Preliminary data collection and recruitment have started; analysis has yet to be performed.Trial Registration: This study was prospectively registered on February 26, 2018, CliniclTrials.gov: NCT03445559 (2a)
A comparison of eating disorder symptomatology, psychological distress and psychosocial function between early, typical and later onset anorexia nervosa
Authors: Jenkins Zoe , Chait Lior M , Cistullo Leonardo , Castle David J 
Published: September 2020

Abstract
Objective: Epidemiological studies suggest that the incidence of anorexia nervosa (AN) is increasing in younger populations, with some evidence that clinical differences occur according to age of onset (AOO), which may impact prognostic outcomes. The current study sought to compare eating disorder (ED) symptomatology, psychological distress and psychosocial function between early onset (EO), typical onset (TO) and later onset (LO) AN in a large sample of treatment-seeking patients with a diagnosis of AN.Methods: Participants included 249 individuals with a diagnosis of AN who were assessed at an outpatient ED service. The sample was divided into three groups based on AOO; those with an AOO ≤14 years (N=58) were termed ‘EO-AN’, those with an AOO between 15-18 years (N=113) were termed ‘TO-AN’ and those with an AOO of > 18 years (N=78) were termed ‘LO-AN’. Comparisons were made between AOO groups on assessments of ED symptomatology, psychological distress and psychosocial function. Results: EO-AN patients reported a significantly longer illness duration than both TO-AN and LO-AN groups. After controlling for effect of illness duration, the EO-AN group demonstrated significantly higher ED symptomatology and dysmorphic concern compared to the LO-AN group. The EO-AN group demonstrated significantly decreased cognitive flexibility compared to both the TO-AN and LO-AN groups.Discussion: These findings suggest that clinical differences do occur according to AOO in AN whereby EO-AN may represent a more severe form of illness that is not attributable to increased illness duration. Treatment strategies which specifically address patients with EO-AN may improve long term health outcomes and recovery.
The Effectiveness of a Training Programme in Everyday Cognition in Older Adults: A Randomised Controlled Trial
Authors: Gómez Celia Sánchez , Rodríguez Eduardo José Fernández 
Published: September 2020

Abstract
Background: Everyday cognition is the application of basic cognitive skills and knowledge of the specific domain for the resolution of problems that are integrated within the instrumental domains of functioning. The main objective to evaluate the effectiveness of a Training Programme in Everyday Cognition in order to improve the levels of everyday cognition and global cognitive performance in older adults.Methods: Experimental, randomised, stratified, prospective, longitudinal study using a fixed-assignment parallel scheme with an experimental group and a control group. The sample was composed of healthy older adults. The intervention of the experimental group consisted of an Everyday Cognition Training Programme, and the intervention of the control group consisted of a Conventional Cognitive Training Programme. The Rapid Assessment of Cognitive Functions test (ERFC, for its acronym in French) and the Everyday Cognition Battery test (ECB) were used for the assessment.Results: Total sample (n=237) composed of 44 men and 223 women, with a mean age of 73.45 years. Statistically significant differences (p <0.001) were observed evidenced between the control group and the experimental group in both the ECB and ERFC variables; in the final evaluation of the study and in the follow-up.Conclusion: The use of a Daily Cognition Training Programme presents greater benefits in terms of both global cognitive performance and everyday cognition than the use of a Traditional Conventional Cognitive Training Programme in elderly adults.Trial registration: ClinicalTrials.gov: NCT04041999 (https://clinicaltrials.gov/ct2/show/NCT04041999)Retrospectively registered.
Construction of a patient decision aid for the treatment of uncomplicated urinary tract infection in primary care
Authors: VINCENT Yves-Marie , FRACHON Adèle , BUFFETEAU Clotilde , CONORT Guillaume 
Published: September 2020

Abstract
Background: Uncomplicated urinary tract infection (uUTI) is a frequent disorder in general practice. The risk of developing pyelonephritis remains low after uUTI, nonetheless, empiric antibiotic therapy is frequently prescribed for symptomatic purposes. This can lead to adverse effects and antibiotic resistance. Furthermore, patients sometimes wish to avoid taking antibiotics. Some European countries recommend discussing a delayed prescription with the patient and developing a shared decision. The aim of our study is to develop a patient decision aid (PtDA) that can be used in primary care to make a shared decision about whether to treat uUTI with antibiotics or not.Methods: We followed the steps recommended by the International Patient Decision Aids Standards, with a scoping phase, a design phase (including focus groups and literature review),and an alpha-testing phase. A steering group, made up of patients and physicians, met throughout the study to develop a draft and then a final version of a prototype PtDA.Results: The information included in the PtDA is the definition of uUTI, information on the options, their benefits, risks, and consequences, based on a review of the literature. The results of the focus group made it possible to determine the patient's values and preferences to be considered in decision-making, namely: the discomfort felt, the impact on daily life, the representations of antibiotics, and the position relative to the risk of adverse effect. The choices of presentation, organisation and design are the result of the work of the steering group, improved by feedback from alpha testing.Conclusions: Our results confirm a need for shared decision-making and the equipoise in this situation. More advice from outside physicians is still lacking. This PtDA needs to be validated in a beta-testing phase, and then tested in a clinical study comparing its use with the systematic prescription approach.
Unrecognized Geriatric Depression in the Emergency Department of a Teaching Hospital in Nepal: Prevalence, Contributing Factors, and Metric Properties of 5 item Geriatric Depression Scale in this Population
Authors: Shrestha Roshana , Shrestha Anmol Purna , Shrestha Abha , Kamholz Barbara 
Published: September 2020

Abstract
Background: Depression is prevalent but poorly recognized in the Emergency Department (ED). We aimed to identify the frequency of unrecognized geriatric depression and its possible determinants in the ED using the 15-item geriatric depression scale (GDS). We also aimed to explore the performance of the shorter, five-item GDS as compared to the 15-item GDS.Methods: This was a cross-sectional study of the ED patients ≥ 60 years. The previously validated Nepali version of GDS-15 screened the sample into “no”, “mild-moderate” and “severe" depression using cutoff values of 4/5, and 8/9 respectively. Demographic and socioeconomic factors, comorbidities and health seeking behaviors were studied and the relation was assessed with binary (Chi-square and Kruskal-Wallis test) and multinomial regression analysis. The performance of GDS-5 was compared with the GDS-15 as standard. Cronbach’s alpha was calculated to investigate reliability. Validity was assessed by calculating sensitivity, specificity, positive predictive value, negative predictive value, Spearman’s correlation, receiver operating characteristic curve, and kappa coefficient. Results: 280 patients were enrolled with an overall prevalence of unrecognized depression of 45.7 % [104 (81.3%) mild-moderate depression, and 24 (18.8%) severe depression]. The mean age of the sample was 71.36 with female predominance (61%), and 82.5% were illiterate. In the binary analysis, those who had more pain, visited the ED more often, had musculoskeletal diseases and sleep problems, mobility problems, visited local healers previously, and who reported self-perceived “heart and mind” disease showed statistically significant differences among the three categories. In multinomial regression analysis, visits to local healers, sleep problems and frequency of pain were significantly related to depression. The sensitivity, specificity, area under curve and Spearman’s correlation of GDS-5 were 75.8%, 96%, 0.919, and 0.827 respectively. Cronbach's alpha for GDS-5 was low (0.416), therefore a new version was proposed which improved the sensitivity to 90.6% and Cronbach’s alpha to 0.623. Conclusions: Unrecognized geriatric depression was highly prevalent which urges the need for ED-based interventions for screening and referral. The proposed brief GDS-5 correlated well with the GDS-15 with better validity and internal reliability and offers a more expeditious form of screening for geriatric depression in emergency settings in Nepal.
Clinical outcomes of chemotherapy in patients with undifferentiated carcinoma of the pancreas: A retrospective multicenter cohort study
Authors: Imaoka Hiroshi , Ikeda Masafumi , Maehara Kosuke , Umemoto Kumiko , Ozaka Masato , Kobayashi Satoshi , Terashima Takeshi , Inoue Hiroto , Sakaguchi Chihiro , Tsuji Kunihiro , Shioji Kazuhiko , Okamura Keiya , Kawamoto Yasuyuki , Suzuki Rei , Shirakawa Hirofumi , Nagano Hiroaki , Ueno Makoto , Morizane Chigusa , Furuse Junji 
Published: September 2020

Abstract
Background: Undifferentiated carcinoma (UC) of the pancreas is a rare subtype of pancreatic cancer. Although UC has been considered a highly aggressive malignancy, no clinical studies have addressed the efficacy of chemotherapy for unresectable UC. Therefore, we conducted multicenter retrospective study to investigate the efficacy of chemotherapy in patients with UC of the pancreas.Methods: This multicenter retrospective cohort study was conducted at 17 institutions in Japan between January 2007 and December 2017. A total of 50 patients treated with chemotherapy were analyzed.Results: The median overall survival (OS) in UC patients treated with chemotherapy was 4.08 months. The details of first-line chemotherapy were as follows: gemcitabine (n=24), S-1 (n=12), gemcitabine plus nab-paclitaxel (n=6), and other treatment (n=8). The median progression-free survival (PFS) was 1.61 months in the gemcitabine group, 2.96 months in the S-1 group, and 4.60 months in the gemcitabine plus nab-paclitaxel group. Gemcitabine plus nab-paclitaxel significantly improved PFS compared with gemcitabine (p=0.014). The objective response rate (ORR) was 4.2% in the gemcitabine group, 0.0% in the S-1 group, and 33.3% in the gemcitabine plus nab-paclitaxel group. Gemcitabine plus nab-paclitaxel also showed a significantly higher ORR compared with both gemcitabine and S-1 (gemcitabine plus nab-paclitaxel vs. gemcitabine: p=0.033; gemcitabine plus nab-paclitaxel vs. S-1: p=0.034). A paclitaxel-containing first-line regimen significantly improved OS compared with a non-paclitaxel-containing regimen (6.94 months vs. 3.75 months, respectively; p=0.041). After adjustment, use of a paclitaxel-containing regimen in any line was still an independent predictor of OS (hazard ratio for OS, 0.221; 95% confidence interval, 0.076 – 0.647; p=0.006) in multiple imputation by chained equation.Conclusions: The results of the present study indicate that a paclitaxel-containing regimen would offer relatively longer survival, and it is considered a reasonable option for treating patients with unresectable UC.