bluuebunny/crossref_metadata_2025_split huggingface dataset:
Adapting isotonic dose-finding to a dynamic set of drug combinations with application to a phase I leukemia trial
Authors: Wages Nolan A , Reed Daniel R , Keng Michael K , Conaway Mark R , Petroni Gina R 
Published: January 2021

Background/aims This article describes the proposed design of a phase I study evaluating the safety of ceramide nanoliposome and vinblastine among an initial set of 19 possible dose combinations in patients with relapsed/refractory acute myeloid leukemia and patients with untreated acute myeloid leukemia who are not candidates for intensive induction chemotherapy. Methods Extensive collaboration between statisticians and clinical investigators revealed the need to incorporate several adaptive features into the design, including the flexibility of adding or eliminating certain dose combinations based on safety criteria applied to multiple dose pairs. During the design stage, additional dose levels of vinblastine were added, increasing the dimension of the drug combination space and thus the complexity of the problem. Increased complexity made application of existing drug combination dose-finding methods unsuitable in their current form. Results Our solution to these challenges was to adapt a method based on isotonic regression to meet the research objectives of the study. Application of this adapted method is described herein, and a simulation study of the design’s operating characteristics is conducted. Conclusion The aim of this article is to bring to light examples of novel design applications as a means of augmenting the implementation of innovative designs in the future and to demonstrate the flexibility of adaptive designs in satisfying changing design conditions.
Safety culture and systems thinking for predicting safety competence and safety performance among registered nurses in Saudi Arabia: a cross-sectional study
Authors: Mahsoon Alaa Nabil , Dolansky Mary 
Published: January 2021

Background Medical errors are a worldwide concern and the contribution of nurses’ safety competence and performance to these errors is a high priority. It has been over 20 years since the first report of the need to address medical errors. New approaches are needed for enhancing safety competence and performance. Aims This study explored the relationships among systems thinking, educational level, safety culture, safety competence and safety performance among registered nurses working in medical and surgical units in Saudi Arabia. Methods A correlational cross-sectional design with a convenience sample of 84 registered nurses was used. Results Systems thinking predicted 16% of safety knowledge ( F[2, 81] = 7.61, P = 0.001), while safety culture, baccalaureate education and completion of safety training predicted 19% of safety skill ( F[3, 78] = 2.80, P = 0.001). A safety culture that promoted learning from mistakes predicted 15% of safety performance measured based on nurses’ self-report of the number of errors in the past 3 months ( F[3, 75] = 2.86, P = 0.008). Conclusions Professional development including systems thinking and safety training are the necessary next steps for nurses. In addition, policy changes facilitating organisations to support learning from mistakes will contribute to reducing medical errors.
A volar approach to on-top plasty for correction of radial polydactyly: a case series of 21 patients
Authors: Fang Xia , Chan Ping-tak , Zhou Shengbo , Dai Xinyi , Guo Ruiji , Wang Bin 
Published: January 2021

Correction of unequal radial polydactyly in which neither thumb duplicates possess both well-developed proximal and distal components, remains challenging. Current techniques using on-top plasty techniques require circumferential incisions, often resulting in postoperative swelling and dorsal scars. We described our experience using a volar approach to achieve better aesthetic and functional results. Twenty-one patients underwent this surgery between 2008 and 2018, with a mean follow-up of 5.1 years. The mean flexion–extension arc for the metacarpophalangeal joint was 75° and that of the interphalangeal joint was 43°. Mean percentage of key, tripod and tip pinch strength were 77%, 79% and 77%, respectively, when compared with the contralateral side. The Vancouver Scar Scale showed an average score of 1.2. We conclude from our study that the volar approach to on-top plasty is a good technique for the correction of unequal radial polydactyly, with good functional and aesthetic results. Level of evidence: IV
Adapting care provision and advocating for unprotected unaccompanied minors in Paris in the context of COVID-19
Authors: Gautier Lara , Poveda Juan-Diego , Nguengang Wakap Stéphanie , Bouchon Magali , Quesnel-Vallée Amélie 
Published: January 2021

Unaccompanied minors (UMs) are children under 18 who arrive on the territory of a foreign country without the care of a guardian. In many countries their access to social and health care services depends on their legal recognition as minors. For instance, in France, high rejection rates of minor status place unprotected UMs in social precarity, such that in Paris, civil society organizations (CSOs) have stepped in to offer social, medical, and psychological care to unprotected UMs. In the context of the COVID-19 pandemic however, CSOs had to adapt their care provision. We review promising CSO-led initiatives to ensure continuity of care for this population. In doing so, we highlight how, by promoting UMs’ healthy behaviors in the context of the pandemic, continued social interactions between CSO members and unprotected UMs may have contributed to disease prevention among UMs. In addition, CSOs have continued to advocate for sheltering unprotected UMs, calling on public authorities to take action.
Cross-cultural adaptation, validity, and reliability of the Persian version of the Upper Limb Functional Index
Authors: Mokhtarinia Hamid Reza , Zareiyan Armin , Gabel Charles Philip 
Published: January 2021

Introduction The Upper Limb Functional Index (ULFI) is a patient-reported outcome measure (PROM) designed to evaluate both the functional status and the level of participation in patients with upper limb musculoskeletal disorders (ULMSDs). The purpose of this study was translation, cross-cultural adaptation, and psychometric evaluation of the original ULFI into Persian (ULFI-Pr). Methods The original ULFI was translated into Persian through double forward and backward translations. Consecutive symptomatic upper limb patients (n = 180, male = 60%, age = 38.21 ± 7.13) were recruited and completed the ULFI-Pr and the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaires. Internal consistency and test-retest reliability were determined using Cronbach’s Alpha and the Intra-class Correlation Coefficient (ICC2.1). Criterion validity was analyzed by evaluating the Pearson’s r correlation coefficient between the ULFI-Pr and DASH questionnaires. Construct validity was examined through exploratory factor analysis (EFA) using Maximum Likelihood Extraction with Promax rotation. Results The original ULFI was translated and cross-culturally adapted into Persian with only minor wording changes. The ULFI-Pr demonstrated high levels of internal consistency (α = 0.91) and test-retest reliability (ICC2.1=0.92). The correlation between the ULFI and DASH was high (r = 0.71). The EFA demonstrated a one-factor structure that explained 38.2% of total variance. No floor or ceiling effects were observed. Conclusion The ULFI-Pr can be considered as a region-specific, single-factor structure PROM for evaluation of patients with upper limb disorders for clinical and research purposes in Persian language populations.
Posterior Ankle Scope Approach to Symptomatic Os Trigonum Removal
Authors: Thompson John M. , Langan Travis M. , Hyer Christopher F. 
Published: January 2021

Introduction Os trigonum can become symptomatic following acute or chronic repetitive compression of the posterior ankle. Following conservative treatment failure, removal is often warranted. Current surgical options include traditional open resection and endoscopic removal. The purpose of this article is to review a population of patients who underwent endoscopic excision of symptomatic accessory os trigonum through a posterior approach and evaluate the outcomes of the procedure. Methods From May 2009 to September 2018, all patients who underwent excision of a symptomatic os trigonum were reviewed. Outcomes of interest were major and minor complications and time to return to full weight-bearing activities. Postoperative protocol included 5 to 7 days non–weight-bearing and 1 to 2 weeks of protected weight-bearing followed by full release to weight-bearing activities. Results Twelve patients who met the inclusion criteria were studied. Mean follow-up was 10.2 (±7.4) months with no major complications and 1 minor wound complication. Average advancement to protected weight-bearing was 7.1 days. Average return to full weight-bearing activities without restriction was 24.4 days. Conclusion The current study describes the technique and results to minimally invasive os trigonum removal with favorable postoperative outcomes. Results demonstrated minimal complications and postoperative pain, also quick return to weight-bearing and full activity. Level of Evidence: Therapeutic, Level IV: Case series
Current antipsychotic agent use and risk of venous thromboembolism and pulmonary embolism: a systematic review and meta-analysis of observational studies
Authors: Liu Yinzhao , Xu Jun , Fang Kacey , Xu Yue , Gao Ju , Zhou Chao , Tang Xiaowei , Fang Xinyu , Chen Jiu , Xie Chunming , Zhang Fuquan , Zhang Xiangrong , Wang Congjie 
Published: January 2021

Background: Antipsychotic agents (APS) are widely used drugs to treat psychotic symptoms and can effectively reduce both positive and negative symptoms of schizophrenia. For decades, some studies suggested that there is a relationship between using APS and the risk of venous thromboembolism (VTE) and pulmonary embolism (PE). However, results remain inconclusive. Method: This review has been registered in International Prospective Register of Systematic Reviews (PROSPERO, ID: CDR42020155620). Relevant studies were identified among observational studies published up to 1 October 2019 in the databases MEDLINE, EMBASE, and Cochrane Library. Random or fixed-effects models were used to calculate the pooled odds ratio (OR). Results: In total, 28 observational studies were included. The results showed that compared with non-users, current APS users have significantly increased risks of VTE [OR 1.55 95% confidence interval (CI) 1.36, 1.76] and PE (OR 3.68, 95% CI 1.23, 11.05). Subgroup analyses suggested that new users were associated with a higher risk of VTE (OR 2.06, 95% CI 1.81, 2.35). For individual drugs, increased risk of VTE and PE was observed in taking haloperidol, risperidone, olanzapine, prochlorperazine but not in chlorpromazine, quetiapine or aripiprazole. However, careful interpretation is needed because of high heterogeneity among studies and scarce data. Conclusion: The present comprehensive meta-analysis further indicates a significantly increased risk of VTE and PE in current APS users compared with non-users. Subgroup analyses suggest that new users are more likely to develop VTE. However, due to significant heterogeneity among studies, conclusions should be considered with caution.
Leukocytosis during cervical preparation with osmotic dilators for dilation and evacuation
Authors: Benson Lyndsey S , Stevens Jordan , Micks Elizabeth A , Prager Sarah W 
Published: January 2021

Objectives: To describe leukocytosis trends during cervical preparation with osmotic dilators for second-trimester dilation and evacuation procedures, and to determine whether there is a difference in leukocytosis seen with laminaria versus Dilapan-S. Methods: We conducted a retrospective cohort study of 986 women presenting for dilation and evacuation from April 2008 through March 2009 at an outpatient clinic network. We included all procedures at ⩾14 weeks’ gestation where laminaria or Dilapan-S dilators were used for overnight dilation. All women had routine white blood cell testing during the study period. Results: There was a median increase of 2.4 × 103/μL white blood cell count (95% confidence interval 2.2–2.7 × 103/μL) from beginning of cervical preparation to the day of procedure (95% confidence interval and p value). Women receiving laminaria ( n = 805) versus Dilapan-S ( n = 181) had a greater increase in white blood cell count from baseline (median increase 2.7 versus 1.2 × 103/μL, p < 0.001), including when adjusting for age, gestational age, parity, baseline white blood cell count, and number of dilators placed. Conclusion: There is increased leukocytosis during the course of cervical preparation with osmotic dilators, and this is increased with use of laminaria versus Dilapan-S. Rates of clinically recognized infection in second-trimester abortion are low regardless of dilator type used.
Outcomes of Oblique Lateral Interbody Fusion for Adult Spinal Deformity: A Systematic Review and Meta-Analysis
Authors: Zhu Lei , Wang Jun-Wu , Zhang Liang , Feng Xin-Min 
Published: January 2021

Study Design: A systematic review and meta-analysis. Objectives: To evaluate clinical and radiographic outcomes, and perioperative complications of oblique lateral interbody fusion (OLIF) for adult spinal deformity (ASD). Methods: We performed a systematic review and meta-analysis of related studies reporting outcomes of OLIF for ASD. The clinical outcomes were assessed by visual analogue scale (VAS) and Oswestry Disability Index (ODI). The radiographic parameters were evaluated by sagittal vertical axis (SVA), pelvic tilt (PT), sacral slope (SS), thoracic kyphosis (TK), lumbar lordosis (LL), pelvic incidence-lumbar lordosis (PI-LL), Cobb angle and fusion rate. A random effects model and 95% confidence intervals (CI) were performed to investigate the results. Results: A total of 16 studies involving 519 patients were included in the present study. The mean difference of VAS-back score, VAS-leg score and ODI score before and after surgery was 5.1, 5.0 and 32.3 respectively. The mean correction of LL was 20.6°, with an average of 6.9° per level and the mean correction of Cobb was 16.4°, with an average of 4.7° per level. The mean correction of SVA, PT, SS, TK and PI-LL was 59.3 mm, 11.7°, 6.9°, 9.4° and 20.6° respectively. The mean fusion rate was 94.1%. The incidence of intraoperative and postoperative complications was 4.9% and 29.6% respectively. Conclusions: OLIF is an effective and safe surgery method in the treatment of mild or moderate ASD and it has advantages in less intraoperative blood loss and lower perioperative complications.
The Impact of Intraoperative Image-Guidance Modalities and Neurophysiologic Monitoring in the Safety of Sacroiliac Fusions
Authors: Montenegro Thiago Scharth , Hoelscher Christian , Hines Kevin , Thalheimer Sara , Matias Caio , Wilent Bryan , Harrop James , Heller Joshua E. 
Published: January 2021

Study Design: Retrospective observational cohort. Objective: A review of efficiency and safety of fluoroscopy and stereotactic navigation system for minimally invasive (MIS) Sacroiliac (SI) fusion through a lateral technique. Methods: Retrospective analysis of an observational cohort of 96 patients greater than 18 years old, that underwent MIS SI fusion guided by fluoroscopy or navigation between January 2013 and April 2020 with a minimum of 3 months follow-up. Intraoperative neuromonitoring (IONM) with a variable combination of electromyography (EMG), somatosensory evoked potentials (SSEPs) and motor evoked potentials (MEPs) was also utilized. Results: The overall complication rate in the study was 9.4%, and there was no difference between the fluoroscopy (10.1%), and navigation groups (8%). Neurological complication rate was 2.1%, without a significant difference between both intraoperative guidance modality groups (p = 0.227). There was a significant difference between the modalities of IONM used and the occurrence of neurological injury (p = 0.01).The 2 patients who had a neurological complication postoperatively were monitored only with EMG and SSEP, but none of the patients (n = 76) in which MEPs were utilized had neurologic complication. The mean pain improvement 3 months after surgery was greater in the navigation group (2.44 ± 2.72), but was not statistically different than the improvement in the fluoroscopy group (1.90 ± 2.07) (p = 0.301). Conclusions: No difference in the safety of the procedure was found between the fluoroscopy and the stereotactic navigation techniques. The contribution of the IONM to the safety of SI fusions could not be determined, but the data indicates that MEPs provide the highest level of sensitivity.
Kyphoplasty for Elderly Patients With Vertebral Compression Fractures—Do We Save Lives? Mortality Rates Analysis Comparison in a Long-Term Follow-Up Cohort
Authors: Lotan Raphael , Smorgick Yossi , Anekstein Yoram , Rudik Oren , Prosso Ilia , Hershkovich Oded 
Published: January 2021

Study Design: Retrospective cohort. Objectives: We aimed to compare a large cohort of patients with vertebral compression fractures (VCF) treated in 2 centers using different protocols (conservative vs BKP) and compare mortality rates on a long-term follow-up. Methods: Retrospective cohort held in 2 medical centers (W and AH). All patients admitted with VCF from November 2008 to January 2015 were enrolled in the study. Exclusion criteria were patients admitted with non-osteoporotic pathological fractures (such as metastatic or MM). Results: Our study included 208 patients treated for VCF, 127 were treated with BKP (88 females, 69.3%) and 81 were treated conservatively (59 females, 72.8%). Patients from Centre W were older and frailer compared to the patients from AH center (Average age 75.12 ± 11.16 vs 69.13 ± 9.61 years and Frailty score of 0.16 ± 0.1 vs 0.12 ± 0.1 respectively, T-test, p < 0.01 for both). Hazard ratios (HR) for age, female gender and frailty were significant for increased mortality, frailty had the highest HR of 182.42 (CI 29.05-1145.33, p < 0.01). Multivariate Cox model was fitted and after accounting for Gender, Age and Frailty, no significant difference was found between the 2 medical centers mortality rates (p = 0.59), thus no difference in mortality rates between BKP and conservative treatment in our study. Conclusion: long-term follow-up following BKP treatment for VCF did not show a reduced mortality rate compared to conservative treatment after accounting for frailty, age and gender. Frailty was the most important factor in predicting mortality. Further RCTs are needed to compare the quality of life differences between the 2 treatment strategies.
Do Bone–Patellar Tendon–Bone ACL-Reconstructed Knees Have More Signs of Patellofemoral Posttraumatic Osteoarthritis Than Their Uninjured Contralateral Knees at 2 Years?
Authors: Oak Sameer R. , Cantrell William A. , Altahawi Faysal , Li Xiaojuan , Winalski Carl S. , Flanigan David C. , Reinke Emily K. , Huston Laura J. , Jones Morgan H. , Spindler Kurt P. 
Published: January 2021

Background: The prevalence of patellofemoral joint (PFJ) osteoarthritis ranges from 8% to 47% at 7 to 10 years after anterior cruciate ligament reconstruction (ACLR) using bone–patellar tendon–bone (BTB) autograft. In performing BTB ACLR, some hypothesize that either trauma caused by harvest of the BTB autograft or altered biomechanics contributes to PFJ posttraumatic osteoarthritis. Purpose/Hypothesis: To determine whether knees with ACLR using a BTB autograft show early signs of posttraumatic osteoarthritis as compared with the contralateral uninjured knee 2 years after ACLR. We hypothesized that a BTB autograft will not increase the prevalence of PFJ osteoarthritis. Study Design: Cohort study; Level of evidence, 3. Methods: Bilateral knee 3-T magnetic resonance imaging (MRI) scans were collected in 57 patients (mean age, 20.3 years; 28 men) from a single site at a minimum of 2 years after ACLR. Structural MRI assessment of the knees was performed using the MRI Osteoarthritis Knee Score semiquantitative scoring system by a board-certified musculoskeletal radiologist. The presence of cartilage defects in the patellofemoral compartment was compared between the reconstructed and contralateral uninjured knees using logistic regression analyses. Results: There were no significant differences in the prevalence of cartilage defects (full thickness or any thickness) in the PFJ between the BTB ACLR knees and the contralateral control knees: 38.6% of BTB ACLR knees had PFJ cartilage defects versus 31.6% of contralateral control knees ( P > .391). The 95% CI for the difference between these groups was –9.0% to 23.0%. Conclusion: When comparing BTB ACLR knees with the uninjured contralateral knees in the study patients, we failed to observe statistically significant differences in the prevalence of PFJ cartilage lesions of full thickness or any thickness. These results should be used in shared decision-making with athletes when choosing the appropriate autograft during reconstruction. Our wide 95% CIs secondary to a smaller sample size demonstrate a need for larger studies in this area to more accurately describe the difference between the operative and contralateral knees.
Proximal Biceps Tenodesis Incorporated into Supraspinatus Repair: A Case Series and Technical Description
Authors: Veenstra Joshua M. , Geeslin Andrew G. , Uggen Christopher W. 
Published: January 2021

Background: Biceps tendon pathology is commonly associated with rotator cuff tears. A multitude of different biceps tenodesis techniques have been studied, with limited clinical data on arthroscopic biceps tenodesis techniques incorporated into rotator cuff repairs. Purpose: To evaluate the outcomes of an arthroscopic biceps tenodesis incorporated into a supraspinatus tendon repair. Study Design: Case series; Level of evidence, 4. Methods: Patients undergoing surgical treatment of supraspinatus tendon tears with concomitant biceps tendon pathology were prospectively enrolled from 2014 to 2015. A total of 32 patients underwent combined biceps tenodesis and rotator cuff repair; of these, 19 patients were evaluated for a mean of 2.0 years. The primary outcome measures were the American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES; patient self-report and physician assessment sections), visual analog scale (VAS) pain score, responses to specific biceps-related assessments, and biceps specific physical exam findings. Results: Patient-reported ASES scores improved from 45.9 preoperatively to 91.6 at the 2-year follow-up ( P < .001). Pain VAS scores improved from 5.2 preoperatively to 0.7 at the 2-year follow-up ( P < .001). Preoperatively, 18 patients had a positive Speed test; all were negative at 5 months postoperatively, and 21 patients had bicipital groove tenderness preoperatively, which resolved in all 21 patients at 5 months postoperatively. At the 2-year follow-up, 2 patients had cramping arm pain and 4 patients noticed a change in arm contour. There were no reoperations. No complications occurred in the study group. Conclusion: Arthroscopic biceps tenodesis incorporated into a supraspinatus tendon repair was a safe and reliable option for biceps pathology with a concomitant rotator cuff tear.