Reference set for performance testing of pediatric vaccine safety signal detection methods and systems

BackgroundSafety signal detection in spontaneous reporting system databases and electronic healthcare records is key to detection of previously unknown adverse events following immunization. Various statistical methods for signal detection in these different datasources have been developed, however none are geared to the pediatric population and none specifically to vaccines. A reference set comprising pediatric vaccine-adverse event pairs is required for reliable performance testing of statistical methods within and across data sources.MethodsThe study was conducted within the context of the Global Research in Paediatrics (GRiP) project, as part of the seventh framework programme (FP7) of the European Commission. Criteria for the selection of vaccines considered in the reference set were routine and global use in the pediatric population. Adverse events were primarily selected based on importance. Outcome based systematic literature searches were performed for all identified vaccine-adverse event pairs and complemented by expert committee reports, evidence based decision support systems (e.g. Micromedex), and summaries of product characteristics. Classification into positive (PC) and negative control (NC) pairs was performed by two independent reviewers according to a pre-defined algorithm and discussed for consensus in case of disagreement.ResultsWe selected 13 vaccines and 14 adverse events to be included in the reference set. From a total of 182 vaccine-adverse event pairs, we classified 18 as PC, 113 as NC and 51 as unclassifiable. Most classifications (91) were based on literature review, 45 were based on expert committee reports, and for 46 vaccine-adverse event pairs, an underlying pathomechanism was not plausible classifying the association as NC.ConclusionA reference set of vaccine-adverse event pairs was developed. We propose its use for comparing signal detection methods and systems in the pediatric population.     

The art of consent: visual materials help adult patients make informed choices about surgical care

Abstract

Supporting patients in making informed healthcare decisions is a cornerstone of ethical medical practice. Surgeons frequently draw for and show images to patients when consenting them for operations but the value of this practice in informed decision-making is unclear. An audit was conducted in a General Surgery Department. 244 patients completed questionnaires on the value of visual materials when giving consent for surgery. The complexity of the operations was classified into “simple”, “moderate” or “complex”. 100% of patients felt they had given informed consent to surgery. 62% of patients received at least one form of visual material during the consenting process. All patients who received a drawing, and 99% of those provided with other images, valued these resources. Visual materials were considered more useful to patients when giving consent for moderate or complex operations than simple ones. Approximately one third of patients who did not receive visual materials would have appreciated these when making an informed decision. This research highlights the value of surgeons drawing for, and providing other visual resources to, their patients as part of the consent process. There is a role for further research and training materials in drawing skills for surgeons.     

Subacute posttraumatic ascending myelopathy (SPAM): A potential complication of subarachnoid shunt for syringomyelia?

Context: Treatment of primary spinal syringomyelia is still controversial. Among others, shunting syrinx fluid to the subarachnoid, peritoneal or pleural space has been utilized with varying success. Shunt obstruction, migration, and infection represent the most common complications of these procedures.

Findings: The authors present the case of an 81-year-old woman who developed an unusual neurological deterioration resembling a subacute posttraumatic ascending myelopathy (SPAM) after the insertion of a syringosubarachnoid shunt for the treatment of slow-growing D10 syringomyelia.

Conclusion/Clinical Relevance: To date, no cases of SPAM secondary to the insertion of a syringosubarachnoid shunt for the treatment of syringomyelia have been reported. The potential pathogenesis related to this phenomenon is discussed.     

Event-related potential changes due to early-onset Parkinson’s disease in parkin (PARK2) gene mutation carriers and non-carriers

ObjectiveTo investigate cognitive functions in non-demented patients with early-onset Parkinson's disease (PD), and to compare PARK2 gene mutation carriers and non-carriers by means of event-related brain potentials (ERPs).MethodsThe participants comprised patients with early-onset PD (EOPD) and healthy controls (HC). Patients with EOPD were divided into two groups as carriers of known pathogenic variants of PARK2 gene (EOPD-PC) and non-carriers of genes involved in familial PD (EOPD-NC). ERP data were collected during auditory oddball and visual continuous performance test (CPT).ResultsBoth EOPD groups (EOPD-PC and EOPD-NC) displayed reduced and delayed P3 in response to oddball target and CPT NoGo. CPT Go P3 was reduced in EOPD-NC but not in EOPD-PC. Oddball target N1 was reduced and P2 was enhanced in both EOPD-PC and EOPD-NC. In both cognitive tasks, RTs were prolonged and accuracy was lower in EOPD-PC and EOPD-NC.ConclusionsWe found several EOPD-related neurophysiologic changes, implying impairments in cognitive functions. Pairwise comparisons between EOPD-PC and EOPD-NC revealed no significant ERP marker.SignificanceIn this study, the confounding effect of normative aging was somewhat excluded compared with many previous studies. In contrast with the many oddball studies in non-demented PD, we clearly observed reduced and prolonged P3 in early-onset PD. Our NoGo P3 findings also contribute to the limited ERP research concerning response inhibition.     

Endoscopic gastroplasty to treat medically uncontrolled obesity needs more quality data: A systematic review

Endoscopic gastroplasty (EG) has been used in clinical practice to treat obesity. This systematic review has the objective of assessing if there is an acceptable level of scientific evidence on the safety and effectiveness of EG. A thorough search strategy was used up to October 2018, including the 2 most common techniques: endoscopic suturing and the primary obesity surgery endolumenal procedure. The quality of the studies was evaluated through the Joanna Briggs Institute Critical Appraisal tools for use in Systematic Reviews—“Checklist for Case Series”—and summarized using the Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) approach. Only 1 randomized controlled trial (moderate GRADE evidence) was found, and the remaining were case reports or small case series (very low GRADE evidence). The literature has low scientific quality. All studies, with 1 exception, are small case series with short follow-up. One of the randomized controlled trials did not meet the primary endpoint for weight loss in both groups (EG × sham) after 1-year follow-up. The case series reported from 16% to 19% total weight loss, but few had more than 6 months of follow-up. Serious adverse events ranged from 2% to 10%. Based on current literature, there is not enough quality scientific evidence regarding long-term weight loss and the procedure’s safety to recommend the use of EG in current clinical practice.