Background: Lumbar spinal stenosis is a condition of progressive neurogenic claudication that can be managed with lumbar decompression surgery or less invasive interspinous process devices after failed conservative therapy. Popular interspinous process spacers include X-Stop, Vertiflex and Coflex, with X-Stop being taken off market due to its adverse events profile. Methods: A disproportionality analysis was conducted to determine whether a statistically significant signal exists in the three interspinous spacers and the reported adverse events using the Manufacturer and User Facility Device Experience (MAUDE) database maintained by the US Food and Drug Administration. Results: Statistically significant signals were found with each of the three interspinous spacer devices (Coflex, Vertiflex, and X-Stop) and each of the following adverse events: fracture, migration, and pain/worsening symptoms. Conclusions Further studies such as randomized controlled trials are needed to validate the findings.

Background: Lumbar spinal stenosis is a condition of progressive neurogenic claudication that can be managed with lumbar decompression surgery or less invasive interspinous process devices after failed conservative therapy. Popular interspinous process spacers include X-Stop, Vertiflex and Coflex, with X-Stop being taken off market due to its adverse events profile. Methods: A disproportionality analysis was conducted to determine whether a statistically significant signal exists in the three interspinous spacers and the reported adverse events using the Manufacturer and User Facility Device Experience (MAUDE) database maintained by the US Food and Drug Administration. Results: Statistically significant signals were found with each of the three interspinous spacer devices (Coflex, Vertiflex, and X-Stop) and each of the following adverse events: fracture, migration, and pain/worsening symptoms. Conclusions Further studies such as randomized controlled trials are needed to validate the findings.

Background: The International Endocervical Adenocarcinoma Criteria and Classification (IECC) separated endocervical adenocarcinomas into human papillomavirus (HPV) associated (HPVA) and non–HPV-associated (NHPVA) categories by morphology alone. Our primary objective was to assess the accuracy of HPV prediction by the IECC system compared to p16 immunohistochemistry and HPV RNA in-situ hybridization (RISH). Our secondary goal was to directly compare p16 and HPV RISH concordance. Methods: Cases were classified by IECC and stained for p16 and HPV RISH on tissue microarray, with discordant p16/HPV RISH cases re-stained on whole tissue sections. Remaining discordant cases (p16/HPV, IECC/p16, IECC/HPV discordances) were re-reviewed by the original pathologists (n = 3) and external expert pathologists (n = 2) blinded to the p16 and HPV RISH results. Final IECC diagnosis was assigned upon independent agreement between all reviewers. Results: One hundred and eleven endocervical adenocarcinomas were classified originally into 94 HPVA and 17 NHPVA cases. p16 and HPV RISH was concordant in 108/111 cases (97%) independent of the IECC. HPV RISH and p16 was concordant with IECC in 103/111 (93%) and 106/111 (95%), respectively. After expert review, concordance improved to 107/111 (96%) for HPV RISH. After review of the eight discordant cases, one remained as HPVA, four were reclassified to NHPVA from HPVA, two were unclassifiable, and one possibly represented a mixed usual and gastric-type adenocarcinoma. Conclusions p16 and HPV RISH have excellent concordance in endocervical adenocarcinomas, and IECC can predict HPV status in most cases. Focal apical mitoses and apoptotic debris on original review led to the misclassification of several NHPVA as HPVA.

Cord Blood Stem Cell Transplantation ; Female ; Humans ; Infant ; Osteopetrosis ; therapy

INTRODUCTIONCardiorespiratory fitness (CRF) is an independent predictor of voluminous health outcomes and can be measured using non-exercise fitness assessment (NEFA) equations. However, the accuracy of such equations in Asian populations is unknown. The objective of this study was to cross-validate the NEFA equation, developed by Jurca et al in 2005, in the adult Singaporean population.

METHODSA total of 100 participants (57 men, 43 women; aged 18-65 years) were recruited, and their maximal oxygen consumption (VO2 max) was measured in the laboratory by indirect calorimetry. The participants also completed the NEFA questionnaire, which helps to predict VO2 max with the NEFA equation. The relationship between NEFA-predicted and laboratory-measured VO2 max values was analysed.

RESULTSOverall, our study demonstrated a high correlation between the NEFA-predicted and laboratory-measured VO2 max values (r = 0.83). The Pearson's correlation coefficient values for the men and women in the study were 0.61 and 0.77, respectively. To improve the accuracy of the predictive equation, we transformed the original equation developed by Jurca et al into new equations that would allow estimation of VO2 max with and without resting heart rate as a variable.

CONCLUSIONThe modified NEFA equations accurately estimated CRF and may be applied to the majority of adult Singaporeans. With this, health practitioners and researchers are now able to assess CRF levels at both the individual and population levels in either the primary care, fitness or research setting.

Adolescent ; Adult ; Aged ; Exercise Test ; methods ; Female ; Health Status ; Humans ; Male ; Middle Aged ; Models, Statistical ; Oxygen Consumption ; physiology ; Physical Fitness ; physiology ; Predictive Value of Tests ; Reproducibility of Results ; Singapore ; Surveys and Questionnaires ; Young Adult