scholarly journals A gender-medicine post hoc analysis (MetaGeM) project to test sex differences in previous observational studies in different diseases: methodology

Author(s):  
Gilberto Bellia ◽  
Delia Colombo ◽  
Donatella Vassellatti ◽  
Emanuela Zagni ◽  
Simona Sgarbi ◽  
...  
2020 ◽  
Vol 91 (8) ◽  
pp. e9.2-e9
Author(s):  
Richard Cole ◽  
Romi Saha

AimsParkinson’s Disease (PD) medications are well-evidenced for improving motor symptoms. However, often a balancing act is required to ameliorate positive neuropsychiatric symptoms, such as visual hallucinations (VH). Opicapone, a novel COMT inhibitor, has been shown by BIPARK-1 and BIPARK-2 studies to improve wearing-off phenomena but little is known about associated neuropsychiatric symptoms. The aim of this literature review was to investigate any association between opicapone and VH.MethodsA literature review was undertaken on the 18th July 2019 using PubMed, Ovid (using key resources of Embase, Ovid MEDLINE, Global Health and PsycINFO), Web of Science and Scopus. The search terms used were ‘Parkinson’s Disease’ and ‘Opicapone’. The search included full-texts, abstracts, conference abstracts and posters.ResultsThe initial search produced 398 articles; 391 were excluded. Of the 7 articles reviewed there were two randomised controlled trials (RCTs) (BIPARK-1 and -2), two observational studies, two post-hoc analyses of BIPARK-1 and -2, and one retrospective analysis. BIPARK-1 reported VH in 1% of the entacapone group, 8% opicapone 25 mg group and 4% of the opicapone 50 mg group. BIPARK-2 did not report on VH in their randomised phased and reported VH in 0.8% of opicapone patients in their open-label phase but without specifying the associated dose.Chaudhuri et al.’s (2018) post-hoc analysis of BIPARK-1 reported VH in 8% of COMT- naive patients given opicapone, vs. 1% of those given entacapone. Lees et al.’s (2019) post-hoc analysis of BIPARK-1 & -2 reported VH in 4.6% of patients receiving opicapone who were ≥70 years old, vs 0.6% in those younger. Gandor et al.’s (2018) prospective observational study reported VH in 14.8% of patients given opicapone.ConclusionsSeveral factors limit the conclusions drawn about the risk of VH in patients taking opicapone. The RCTs were designed and powered to assess ‘on-off’ phenomena and didn’t include patients >65 or with a psychiatric history. This also limits their post-hoc analyses’ generalisability. The more ‘real-world’ observational studies were small and only available in abstract form with limited details. Lees et al.’s (2019) post-hoc analysis nevertheless reported a higher incidence of VH in the older age group, which is concordant with known risk factors for neuropsychiatric adverse events. Further investigation is required, focusing on older patients and those with a psychiatric history or cognitive impairment.


2020 ◽  
Vol 36 (1) ◽  
pp. 79-83 ◽  
Author(s):  
Adam P. Deveau ◽  
Robert Sheldon ◽  
Connor Maxey ◽  
Deborah Ritchie ◽  
Steve Doucette ◽  
...  

Heart ◽  
2019 ◽  
Vol 106 (7) ◽  
pp. 520-526 ◽  
Author(s):  
Maurizio Gasparini ◽  
Axel Kloppe ◽  
Maurizio Lunati ◽  
Niraj Varma ◽  
Jose B Martinez-Ferrer ◽  
...  

ObjectiveIn implantable cardiac defibrillators (ICDs), long-detection times safely reduce unnecessary and inappropriate therapies. We aimed to evaluate ICD treatment of ventricular arrhythmias in women, compared with men, also taking into account ICD detection.MethodsThe Advance III trial randomised patients implanted with an ICD for primary or secondary prevention in two arms—long and nominal ventricular arrhythmias detection times before therapy delivering (number of intervals needed to detect (NID) 30/40 and 18/24, respectively). The main endpoint of this post hoc analysis was the incidence of ICD therapies evaluated through Kaplan-Meier method and univariate Cox regression models.ResultsOverall, 1902 patients (304 women, 65±11 years) were randomised. Women showed a lower risk of ICD therapy (HR 0.63, 95% CI 0.43 to 0.93, p=0.022); this difference was observed only in the long-detection arm (HR 0.37, p=0.013) and not in the short detection arm (HR 0.82, p=0.414). No significant sex differences were observed concerning inappropriate therapies and mortality rate. Long-detection settings significantly reduced overall ICD therapies and appropriate ICD therapies, both in women (overall HR 0.31, p=0.007; appropriate HR 0.33, p=0.033) and in men (overall HR 0.69, p=0.006; appropriate HR 0.73, p=0.048).ConclusionsIn patients with ICDs, the strategy of setting a long-detection time to treat ventricular arrhythmias (NID 30/40) reduces overall delivered therapies, both in women and men, when compared with nominal setting (NID 18/24). The reduction was significantly higher in women. Overall, women were less likely to experience ICD therapies than men; this result was only observed in the long-detection arm.Clinical trial registrationNCT00617175.


2018 ◽  
Vol 12 (3) ◽  
pp. 213-218 ◽  
Author(s):  
Giuseppe Civardi ◽  
Patrizia Mordenti ◽  
Gualberto Gussoni ◽  
Cecilia Politi ◽  
Pietro Seghini ◽  
...  

Conflicting results come from epidemiological studies on the correlations between gender and pain in hospitalized patients. No specific data are reported in patients admitted to Internal Medicine Units (IMUs). Post-hoc analysis of the FADOI-DOMINO study, performed in 26 IMUs in Italy, with two cross-sectional surveys interspersed with an educational program. The 5200 medical charts of the FADOI-DOMINO study were re-analyzed. The following sex differences were highlighted: i) a greater pain prevalence was evidenced in women in the Pre-phase; ii) among patients with chronic pain, anxiety and depression were significantly more present in women compared with men; iii) oncologic pain was more prevalent in men; in a specular way, nononcologic pain showed a greater prevalence in women in both phases; iv) strong opioids therapy was higher for men. Some sex differences in pain seem to exist in IMUs, although less evident if compared with those previously reported in other settings. A more careful assessment of coexisting conditions such as anxiety, depression or cognitive impairment can result in a better management of these problems.


2014 ◽  
Vol 17 (7) ◽  
pp. A406 ◽  
Author(s):  
L. Simoni ◽  
D. Colombo ◽  
G. Bellia ◽  
D. Vassellatti ◽  
E. Zagni ◽  
...  

2018 ◽  
Vol 24 ◽  
pp. 80-81
Author(s):  
Konstantinos Toulis ◽  
Krishna Gokhale ◽  
G. Neil Thomas ◽  
Wasim Hanif ◽  
Krishnarajah Nirantharakumar ◽  
...  

2018 ◽  
Vol 24 ◽  
pp. 51-52
Author(s):  
Vanita Aroda ◽  
Danny Sugimoto ◽  
David Trachtenbarg ◽  
Mark Warren ◽  
Gurudutt Nayak ◽  
...  

2004 ◽  
Vol 18 (1) ◽  
pp. 13-26 ◽  
Author(s):  
Antoinette R. Miller ◽  
J. Peter Rosenfeld

Abstract University students were screened using items from the Psychopathic Personality Inventory and divided into high (n = 13) and low (n = 11) Psychopathic Personality Trait (PPT) groups. The P300 component of the event-related potential (ERP) was recorded as each group completed a two-block autobiographical oddball task, responding honestly during the first (Phone) block, in which oddball items were participants' home phone numbers, and then feigning amnesia in response to approximately 50% of items in the second (Birthday) block in which oddball items were participants' birthdates. Bootstrapping of peak-to-peak amplitudes correctly identified 100% of low PPT and 92% of high PPT participants as having intact recognition. Both groups demonstrated malingering-related P300 amplitude reduction. For the first time, P300 amplitude and topography differences were observed between honest and deceptive responses to Birthday items. No main between-group P300 effects resulted. Post-hoc analysis revealed between-group differences in a frontally located post-P300 component. Honest responses were associated with late frontal amplitudes larger than deceptive responses at frontal sites in the low PPT group only.


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