bluuebunny/crossref_metadata_2025_split huggingface dataset:
Prospective Evaluation of the Patient Acceptable Symptom State to Identify Clinically Successful Anterior Cruciate Ligament Reconstruction
Authors: Vega José F. , Jacobs Cale A. , Strnad Gregory J. , Farrow Lutul , Jones Morgan H. , Miniaci Anthony , Parker Richard D. , Rosneck James , Saluan Paul , Williams James S. , Spindler Kurt P. 
Published: March 2019

Background: The length of most patient-reported outcome measures creates significant response burden, which hampers follow-up rates. The Patient Acceptable Symptom State (PASS) is a single-item, patient-reported outcome measure that asks patients to consider all aspects of life to determine whether the state of their joint is satisfactory; this measure may be viable for tracking outcomes on a large scale. Hypothesis: The PASS question would identify clinically successful anterior cruciate ligament reconstruction (ACLR) at 1-year follow-up with high sensitivity and moderate specificity. We defined “clinically successful” ACLR as changes in preoperative to postoperative scores on the Knee injury and Osteoarthritis Outcome Score (KOOS) pain subscale and the KOOS knee-related quality of life subscale in excess of minimal clinically important difference or final KOOS pain or knee-related quality of life subscale scores in excess of previously defined PASS thresholds. Study Design: Cohort study (diagnosis); Level of evidence, 2. Methods: Patients enrolled in a prospective longitudinal cohort completed patient-reported outcome measures immediately before primary ACLR. At 1-year follow-up, patients completed the same patient-reported outcome measures and answered the PASS question: “Taking into account all the activity you have during your daily life, your level of pain, and also your activity limitations and participation restrictions, do you consider the current state of your knee satisfactory?” Results: A total of 555 patients enrolled in our cohort; 464 were eligible for this study. Of these, 300 patients (64.7%) completed 1-year follow-up, of whom 83.3% reported satisfaction with their knee after surgery. The PASS question demonstrated high sensitivity to identify clinically successful ACLR (92.6%; 95% CI, 88.4%-95.6%). The specificity of the question was 47.1% (95% CI, 35.1%-59.5%). The overall agreement between the PASS and our KOOS-based criteria for clinically successful intervention was 81.9%, and the kappa value indicated moderate agreement between the two methods (κ = 0.44). Conclusion: The PASS question identifies individuals who have experienced clinically successful ACLR with high sensitivity. The limitation of the PASS is its low specificity, which we calculated to be 47.1%. Answering “no” to the PASS question meant that a patient neither improved after surgery nor achieved an acceptable final state of knee health. The brevity, interpretability, and correlation of the PASS question with significant improvements on various KOOS subscales make it a viable option in tracking ACLR outcomes on a national or global scale.
Epidemiology of Shoulder Surgery Among Professional Baseball Players
Authors: Chalmers Peter N. , Erickson Brandon J. , D’Angelo John , Ma Kevin , Romeo Anthony A. 
Published: March 2019

Background: Injuries remain a significant problem for professional baseball players. There is little information regarding the incidence and outcomes of shoulder surgical procedures among these athletes. Purpose/Hypothesis: To report the incidence, pathology, procedure type, demographics, and return-to-sport (RTS) rate of shoulder surgery among Major League Baseball (MLB) players. Most shoulder procedures would be performed on pitchers with a history of injury; the labrum would be the most commonly involved; and that the RTS rate would be >50%. Study Design: Descriptive epidemiology study. Methods: All MLB players who underwent surgery between 2012 and 2016 were identified from a database prospectively maintained by MLB. Demographic information and details regarding the procedure were recorded and RTS rates determined. Only those players with a minimum 2-year follow-up were included. Results: There were 581 shoulder procedures performed (542 players; pitchers, 60%; incidence, 1.48%). Overall, 19% of surgical procedures were performed on major league players and 81% on minor league players. Most players were between 20 and 25 years old. The majority of procedures were performed on the posterior and anterior labrum. Of these, 67% involved labral repair. Within rotator cuff surgery, 84% involved debridement; most tears were articular sided (87%); and 75% involved the supraspinatus. Overall, 11% of players had prior shoulder surgery, and 76% spent time on the disabled list before surgery. The overall rate of RTS was 63%. Of those who returned, 86% returned to at least the same level of play or higher as before surgery. Of those who returned to their prior level of play, 73% later ascended to a higher level of play or could not ascend to a higher level because they were already in the majors. Conclusion: Shoulder surgery is uncommon among professional baseball players. Of those players who require surgery, the majority are pitchers and minor league players. Most procedures involve the labrum. Rotator cuff tears are mostly articular-sided supraspinatus tears. The overall RTS rate is 63%. Of those who return, 86% are able to return to the same or higher level of play as before surgery.
Machine Learning Enhances the Efficiency of Cognitive Screenings for Primary Care
Authors: Levy Boaz , Hess Courtney , Hogan Jacqueline , Hogan Matthew , Ellison James M. , Greenspan Sarah , Elber Allison , Falcon Kathryn , Driscoll Daniel F. , Hashmi Ardeshir Z. 
Published: March 2019

Background: Incorporation of cognitive screening into the busy primary care will require the development of highly efficient screening tools. We report the convergence validity of a very brief, self-administered, computerized assessment protocol against one of the most extensively used, clinician-administered instruments—the Montreal Cognitive Assessment (MoCA). Method: Two hundred six participants (mean age = 67.44, standard deviation [SD] = 11.63) completed the MoCA and the computerized test. Three machine learning algorithms (ie, Support Vector Machine, Random Forest, and Gradient Boosting Trees) were trained to classify participants according to the clinical cutoff score of the MoCA (ie, < 26) from participant performance on 25 features of the computerized test. Analysis employed Synthetic Minority Oversampling TEchnic to correct the sample for class imbalance. Results: Gradient Boosting Trees achieved the highest performance (accuracy = 0.81, specificity = 0.88, sensitivity = 0.74, F1 score = 0.79, and area under the curve = 0.81). A subsequent K-means clustering of the prediction features yielded 3 categories that corresponded to the unimpaired (mean = 26.98, SD = 2.35), mildly impaired (mean = 23.58, SD = 3.19), and moderately impaired (mean = 17.24, SD = 4.23) ranges of MoCA score ( F = 222.36, P < .00). In addition, compared to the MoCA, the computerized test correlated more strongly with age in unimpaired participants (ie, MoCA ≥26, n = 165), suggesting greater sensitivity to age-related changes in cognitive functioning. Conclusion: Future studies should examine ways to improve the sensitivity of the computerized test by expanding the cognitive domains it measures without compromising its efficiency.
The physical health of Indigenous people with a mental illness in the Kimberley: is ongoing monitoring effective?
Authors: Stanley Susanne H , Laugharne Jonathan DE , Chapman Murray , Balaratnasingam Sivasankaran 
Published: March 2019

Objective: The aim of this paper is to evaluate the effectiveness of ongoing physical health monitoring for Indigenous Australians with mental health issues in the Kimberley region of Western Australia. Method: This longitudinal, within-groups investigation assessed physical health parameters such as blood pressure and blood glucose levels at baseline and at 18 months for the same cohort. No standardised intervention was in place, but action was taken if results were found to be abnormal. Results: Most measures of physical health remained stable, with mean lipid and fasting glucose levels remaining abnormal over the entire assessment period. Systolic blood pressure showed a significant improvement. Conclusions: More needs to be done to improve the physical health of Indigenous mental health patients – culturally appropriate and secure interventions incorporating holistic models of care are needed.
Otoscopy and aural cytological findings in a population of rescue cats and cases in a referral small animal hospital in England and Wales
Authors: Tyler Sophie , Swales Nicola , Foster Aiden P , Knowles Toby G , Barnard Natalie 
Published: March 2019

Objectives Otitis externa is seen clinically in cats, although studies investigating this condition within the UK are lacking. The objective of this study was to investigate the prevalence of Otodectes cynotis mites and microbial infection in the ear canals of cats in various rescue centres and a referral hospital. Methods Otoscopy was performed in 332 cats. Otoscopic findings were noted, including the gross visualisation of Otodectes species. A sample of cerumen was collected for cytological evaluation and a cerumen smear for detection of Otodectes mites if there was a large amount of aural exudate present. Results O cynotis infestation was noted in 3/341 cats (0.9%, 95% confidence interval [CI] 0.3–2.6). A total of 129/341 (37.8%; 95% CI 32.7–43.0) cats were found to have Malassezia species within one or both ears. Bacteria were found unilaterally in 9/341 (2.6%; 95% CI 1.4–4.9) cats. Analysis of the cytological findings showed an increased likelihood for Malassezia species to be present as age increased (n = 293; Pearson r = 0.204, P <0.001). There was also an increased likelihood of finding Malassezia species in both ears if found within one ear (n = 327; r = 0.499, P <0.001). There was a positive correlation between the number of Malassezia organisms and the quantity of aural exudate (n = 338; r = 0.778, P <0.001). Cats in which Otodectes species infestation were noted (n = 3) had moderate or large quantities of cerumen. Conclusions and relevance This study shows that there was a low prevalence of O cynotis in this cohort of cats. In normal cats it was not unusual to find Malassezia microorganisms upon aural cytology, bacteria were noted far less frequently and in two cats this was associated with underlying anatomical pathology.
Effect of 2-year nutritional supplementation on progression of age-related macular degeneration
Authors: Piatti Alberto , Croce Antonella , Mazzacane Danilo , Traina Giovanni , Ambrosino Lina , Boni Luigi , Lisi Luca , Cascella Maria Caterina , Grunberger Alberto 
Published: March 2019

Purpose: To examine the effect of a long-term nutritional supplementation on age-related macular degeneration progression. Methods: In this prospective, double-blind, placebo-controlled study, 80 patients with intermediate age-related macular degeneration were randomized (2:1) to receive 1 tablet/day of a nutritional supplement containing a mixture of carotenoids, vitamins and omega-3 fatty acids or placebo. Age-related macular degeneration progression assessed by digital fundus photography (primary outcome) and best-corrected visual acuity were evaluated. Differences between arms were tested using chi-square test or Fisher’s exact test. Results: Seventy-four patients completed the follow-up at 24 months (48 in the treated arm and 26 in the placebo arm). An age-related macular degeneration progression was observed in the 2.1% of patients of the treated arm and in the 15.4% of patients in the placebo arm (p = 0.05, Fisher’s exact test). Best-corrected visual acuity data alone were not statistically significant among groups. Conclusion: A clinically meaningful stabilization of intermediate age-related macular degeneration over a period of 2 years may be obtained by treating patients with a mixture of carotenoids, vitamins and omega-3 fatty acids.
Switching from ranibizumab to aflibercept in choroidal neovascularization secondary to angioid streaks
Authors: Sekfali Rim , Mimoun Gérard , Cohen Salomon Yves , Querques Giuseppe , Bandello Francesco , Sacconi Riccardo , Souied Eric H , Capuano Vittorio 
Published: March 2019

Purpose: To evaluate the efficacy of switching from intravitreal ranibizumab to intravitreal aflibercept in choroidal neovascularization secondary to angioid streaks. Design: Multicenter retrospective interventional case series. Methods: Patients previously treated with intravitreal ranibizumab with at least 12-month follow-up (M12) after switching (M0) to intravitreal aflibercept. Switch to intravitreal aflibercept was decided in cases of refractory or recurrent choroidal neovascularization. Primary endpoint: Change of best-corrected visual acuity using the Early Treatment Diabetic Retinopathy Study letters. Secondary endpoints: Mean change of central macular thickness, absence of intraretinal/subretinal fluid on spectral domain optical coherence tomography and the percentage of eyes with absence of leakage on fluorescein angiography. Results: Fourteen eyes of 13 patients were included. Mean best-corrected visual acuity was 65.0 ± 21.03 letters at M0 and 63.5 ± 17.30 letters at M12 (p = 0.5). Secondary endpoints: Mean central macular thickness was 344 ± 194.65 µm at M0 and 268 ± 79.97 µm at M12 (p = 0.008). Absence of intraretinal/subretinal fluid was observed in 71%. Fluorescein angiography (nine eyes) showed absence of leakage in 77% (seven eyes). Conclusion: Switching from intravitreal ranibizumab to intravitreal aflibercept represents a therapeutic option in patients with refractory or recurrent choroidal neovascularization secondary to angioid streaks.
Determination of fasiglifam-induced liver toxicity: Insights from the data monitoring committee of the fasiglifam clinical trials program
Authors: Shavadia Jay S , Sharma Abhinav , Gu Xiangqiong , Neaton James , DeLeve Laurie , Holmes David , Home Phillip , Eckel Robert H , Watkins Paul B , Granger Christopher B 
Published: March 2019

Background Different approaches to safety event collection influence the determination of liver toxicity within drug development programs. Herein, a description of how fasiglifam-induced liver injury was detected is provided. Methods This eight-trial drug development program was intended to evaluate fasiglifam (25 mg, 50 mg) against placebo or active comparators (glimepiride, sitagliptin) in approximately 11,000 suboptimally controlled patients with type 2 diabetes (terminated Dec 2013 due to liver toxicity). Liver safety had been pre-identified as a concern, and within the phase 3 trials, was measured through (1) adverse event reporting, (2) central predefined liver monitoring schedule with various thresholds for potential drug-induced liver injury, and (3) blinded adjudication of serious liver toxicity by a panel of experts in drug-induced liver injury. A single data monitoring committee provided safety oversight across all trials within the program. Findings Prior to program termination, 7595 of 7602 (99.9%) randomized participants across the eight trials received at least one dose of the study drug (fasiglifam, placebo, or active control). No concerning trends were noted in adverse or serious adverse event frequency, suspected unexpected serious adverse reaction, alanine or aspartate transaminase elevations, or hepatobiliary or gastrointestinal adverse events as reported by local site investigators. However, the predefined central liver safety measurements revealed a greater frequency of possible Hy’s Law cases (5 vs 2) and a 3- to 7-fold greater relative risk in alanine or aspartate transaminase elevation (with respect to upper limit of normal) within fasiglifam recipients compared with placebo/active control: alanine or aspartate transaminase > 3×: relative risk 3.34 (95% confidence interval 2.29–4.90), alanine or aspartate transaminase > 5×: relative risk 6.60 (95% confidence interval 3.03–14.38), alanine or aspartate transaminase > 8×: relative risk 6.14 (95% confidence interval 2.18–17.27), and alanine or aspartate transaminase > 10×: relative risk 6.74 (95% confidence interval 2.05, 22.14). All elevations resolved on study drug discontinuation. Drug-induced liver injury was adjudicated as highly likely or probably related in 0.64% of fasiglifam-treated versus 0.06% placebo or active control-treated patients. Conclusion In spite of clear liver toxicity detected with a systematic surveillance program, liver safety signals were not identified from investigator adverse event reporting alone. By integrating key safety monitoring processes within the randomized design of adequately sized clinical trials, the rare but serious liver toxicity signal became clear, leading to timely program termination.
Patient reported outcomes in anti-PD-1/PD-L1 inhibitor immunotherapy registration trials: FDA analysis of data submitted and future directions
Authors: King-Kallimanis Bellinda L , Howie Lynn J , Roydhouse Jessica K , Singh Harpreet , Theoret Marc R , Blumenthal Gideon M , Kluetz Paul G 
Published: March 2019

Background Patient-reported outcome measures can be used to capture the patient’s experience with disease and treatment. Immunotherapy agents including the anti-programmed death receptor-1/programmed death-ligand-1 inhibitor therapies have unique symptomatic side effects and patient-reported outcome data can help to characterize the benefits and burdens associated with therapy. Methods We reviewed registration trials in the Food and Drug Administration database for five anti-programmed death receptor-1/programmed death-ligand-1 inhibitor therapies to characterize trial design and patient-reported outcome assessment strategy (cutoff 31 December 2017). We evaluated the patient-reported outcome measurement coverage of eight key symptoms related to adverse events reported in immunotherapy agent product labels (fatigue, diarrhea, cough, shortness of breath, musculoskeletal pain, rash, pruritus, and fever). Results There were a total of 28 trials across seven disease types and one tumor agnostic indication reviewed, of which 17 were randomized and 25 were open label. Of the 28 trials, 21 contained patient-reported outcome measures and all 21 used >1 instrument. The most common instruments were the EuroQol five dimension (N = 19), and the European Organisation for Research and Treatment of Cancer Quality of Life Core Questionnaire (N = 17). Disease-specific patient-reported outcome tools were included in nine trials (six lung, one head and neck, one melanoma and one renal cell). No trial used a patient-reported outcome strategy assessing all eight selected adverse events. Conclusion Collection of patient-reported outcome data in anti-programmed death receptor-1/programmed death-ligand-1 inhibitor trials were variable and did not consistently assess important symptomatic adverse events. Use of a patient-reported outcome instrument with well-defined functional scales supplemented by item libraries to incorporate relevant symptomatic adverse events may allow for improved understanding of the patient experience while receiving therapy. These data, along with other clinical data such as hospitalizations and supportive care medication use can help inform the benefit–risk assessment for regulatory purposes.
The risk factors associated with colonic injury during percutaneous renal stone surgery – a literature review
Authors: Burns H , Nalagatla S 
Published: March 2019

Objective: A focused literature review was conducted of colonic injuries occurring during percutaneous nephrolithotomy (PCNL) procedures to determine the importance of patient position, identifiable risk factors and methods to avoid colonic injury. Method: A MEDLINE literature search was performed from PubMed and Scopus databases to retrieve all articles relating to colonic injuries occurring during PCNL. Incidence of colonic injury, patient management, position, side of stone and recognised risk factors were compiled for analysis. Results: Of the 35,054 PCNLs carried out, 87 colonic perforations were identified, which results in a 0.25% chance of perforation. A total of 65.5% (57/87) of colonic perforations occurred during left-hand punctures, and 54.0% (47/87) occurred in the prone position. Retrorenal colon, posterior colon, previous renal tract surgery, horseshoe kidney and mobile kidneys were the most common risk factors identified. Discussion: The risk of colonic perforation during PCNL was 0.25% across these studies. It more commonly occurred in the prone position and on the left-hand side. Only four perforations were noted to be in the supine position. A retrorenal colon is implicated as the most common identifiable risk factor. Careful preoperative work-up, planning and intraoperative use of ultrasound combined with fluoroscopy is the best method of preventing a colonic injury. Level of evidence: Not applicable for this multicentre audit.
The Multiple Sclerosis Severity Score: fluctuations and prognostic ability in a longitudinal cohort of patients with MS
Authors: Gross RH , Sillau SH , Miller AE , Farrell C , Krieger SC 
Published: March 2019

Background The Multiple Sclerosis Severity Score (MSSS), combining the Expanded Disability Status Scale (EDSS) and disease duration, attempts to stratify multiple sclerosis (MS) patients based on their rate of progression. Its prognostic ability in the individual patient remains unproven. Objectives To assess the stability of MSSS within individual persons with MS in a longitudinal cohort, to evaluate whether certain factors influence MSSS variability, and to explore the ability of MSSS to predict future ambulatory function. Methods A single-center retrospective review was performed of patients following a single provider for at least 8 years. Mixed model regression modeled MSSS over time. A Kaplan–Meier survival plot was fitted, using change of baseline MSSS by at least one decile as the event. Cox modeling assessed the influence of baseline clinical and demographic factors on the hazard of changing MSSS by at least one decile. Linear models evaluated the impact of baseline EDSS, baseline MSSS, and other factors on the Timed 25-Foot Walk (T25FW). Results Out of 122 patients, 68 (55.7%) deviated from baseline MSSS by at least one decile. Final T25FW had slightly weaker correlation to baseline MSSS than to baseline EDSS, which was moderately strongly correlated with future log T25FW. Conclusion Individual MSSS scores often vary over time. Clinicians should exercise caution when using MSSS to prognosticate.