International Journal of Risk & Safety in Medicine - Volume 28, issue 3

Authors: Healy, D. | Le Noury, J. | Mangin, D.

Article Type: Review Article

Abstract: OBJECTIVE: To investigate possible linkages between neurodevelopmental delay and neurodevelopmental spectrum disorders and exposure to medication with effects on serotonin reuptake inhibition during pregnancy. METHODS: We systematically reviewed the epidemiological literature for studies bearing on this relationship in children born with neurodevelopmental spectrum disorder and related conditions, as well as animal studies giving serotonin reuptake inhibitors to pregnant animals and in addition reviewed the literature for proposals as to possible mechanisms that might link effects on serotonin reuptake with cognitive changes post-partum. The epidemiological studies were analysed to produce Forest plots to illustrate possible relations. …RESULTS: The odds ratio of Autistic Spectrum or related Disorders in children born to women taking serotonin reuptake inhibiting antidepressants during pregnancy in case control studies was 1.95 (95% C.I. 1.63, 2.34) and in prospective cohort studies was 1.96 (95% C.I. 1.33, 2.90). CONCLUSIONS: There appears to be a link between serotonin reuptake inhibition in pregnancy and developmental delay and spectrum disorders in infancy leading to cognitive difficulties in childhood. More work needs to be done to establish more precisely the nature of the difficulties and possible mechanisms through which this link might be mediated. Show more

Keywords: Autism spectrum disorder, neurodevelopmental delay, neurodevelopmental spectrum disorders, antidepressants, serotonin reuptake inhibitors, pregnancy

DOI: 10.3233/JRS-160726

Citation: International Journal of Risk & Safety in Medicine, vol. 28, no. 3, pp. 125-141, 2016

Authors: Le Noury, Joanna | Nardo, John M. | Healy, David | Jureidini, Jon | Raven, Melissa | Tufanaru, Catalin | Abi-Jaoude, Elia

Article Type: Research Article

Abstract: OBJECTIVE: This is an analysis of the unpublished continuation phase of Study 329, the primary objective of which was to compare the efficacy and safety of paroxetine and imipramine with placebo in the treatment of adolescents with unipolar major depression. The objectives of the continuation phase were to assess safety and relapse rates in the longer term. The objective of this publication, under the Restoring Invisible and Abandoned Trials (RIAT) initiative, was to see whether access to and analysis of the previously unpublished dataset from the continuation phase of this randomized controlled trial would have clinically relevant implications for …evidence-based medicine. METHODS: The study was an eight-week double-blind randomized placebo-controlled trial with a six month continuation phase. The setting was 12 North American academic psychiatry centres, from 20 April 1994 to 15 February 1998. 275 adolescents with major depression were originally enrolled in Study 329, with 190 completing the eight-week acute phase. Of these, 119 patients (43%) entered the six-month continuation phase (paroxetine n  = 49; imipramine n  = 39; placebo n  = 31), in which participants were continued on their current treatment, blinded. As per the protocol, we have looked at rates of relapse (based on Hamilton Depression Scale scores) across both acute and continuation phases, and generated a safety profile for paroxetine and imipramine compared with placebo for up to six months. ANOVA testing (generalized linear model) using a model including effects of site, treatment and site x treatment interaction was applied. Otherwise we used only descriptive statistics. RESULTS: Of patients entering the continuation phase, 15 of 49 for paroxetine (31%), 12 of 39 for imipramine (31%) and 12 of 31 for placebo (39%) completed as responders. Across the study, 25 patients on paroxetine relapsed (41% of those showing an initial response), 15 on imipramine (26%), and 10 on placebo (21%). In the continuation and taper phases combined there were 211 adverse events in the paroxetine group, 147 on imipramine and 100 on placebo. The taper phase had a higher proportion of severe adverse events per week of exposure than the acute phase, with the continuation phase having the fewest events. CONCLUSIONS: The continuation phase did not offer support for longer-term efficacy of either paroxetine or imipramine. Relapse and adverse events on both active drugs open up the risks of a prescribing cascade. The previously largely unrecognised hazards of the taper phase have implications for prescribing practice and need further exploration. Show more

Keywords: Paroxetine, SSRIs, imipramine, depression, relapse, taper phase

DOI: 10.3233/JRS-160728

Citation: International Journal of Risk & Safety in Medicine, vol. 28, no. 3, pp. 143-161, 2016

Authors: Buja, Alessandra | Saieva, Anna Maria | Vinelli, Angela | Cacco, Rosaria Manola | Ottolitri, Ketty | De Battisti, Elisa | Dario, Claudio | Baldo, Vincenzo

Article Type: Research Article

Abstract: BACKGROUND: Reporting adverse events (AE) with a bearing on patient safety is fundamentally important to the identification and mitigation of potential clinical risks. OBJECTIVE: The aim of this study was to analyze the AE reporting systems adopted at a university hospital for the purpose of enhancing the learning potential afforded by these systems. RESEARCH DESIGN: Retrospective cohort study METHODS: Data were collected from different information flows (reports of incidents and falls, patients’ claims and complaints, and cases of hospital-acquired infection [HAI]) at an university hospital. A composite risk indicator was developed to combine …the data from the different flows. Spearman’s nonparametric test was applied to investigate the correlation between the AE rates and a Poisson regression analysis to verify the association among characteristics of the wards and AE rates. SUBJECTS: Sixty-four wards at a University Hospital. RESULTS: There was a marked variability among wards AE rates. Correlations emerged between patients’ claims with complaints and the number of incidents reported. Falls were positively associated with average length of hospital stay, number of beds, patients’ mean age, and type of ward, and they were negatively associated with the average Cost Weight of the Diagnosis-related group (DRG) of patients on a given ward. Claims and complaints were associated directly with the average DRG weight of a ward’s patient admissions. CONCLUSIONS: This study attempted to learn something useful from an analysis of the mandatory (but often little used) data flows generated on adverse events occurring at an university hospital with a view to managing the associated clinical risk to patients. Show more

Keywords: Patient safety, adverse events, epidemiology and detection, safety culture, risk management, medical error, measurement/epidemiology

DOI: 10.3233/JRS-160730

Citation: International Journal of Risk & Safety in Medicine, vol. 28, no. 3, pp. 163-170, 2016

Authors: Jargin, S.V.

Article Type: Letter

DOI: 10.3233/JRS-160727

Citation: International Journal of Risk & Safety in Medicine, vol. 28, no. 3, pp. 171-174, 2016

Authors: Grech, Victor

Article Type: Letter

DOI: 10.3233/JRS-160725

Citation: International Journal of Risk & Safety in Medicine, vol. 28, no. 3, pp. 175-176, 2016

Authors: Scherb, Hagen

Article Type: Letter

DOI: 10.3233/JRS-160729

Citation: International Journal of Risk & Safety in Medicine, vol. 28, no. 3, pp. 177-180, 2016