Summary
We aim to demonstrate, in a sufficiently powered and standardized study, that the success rate of inducing psychogenic nonepileptic seizures (PNES) without placebo (saline infusion) is noninferior to induction with placebo. The clinical data of 170 consecutive patients with suspected PNES who underwent induction with placebo from January 21, 2009 to March 31, 2013 were pair‐matched with 170 consecutive patients with suspected PNES who underwent the same induction technique but without addition of placebo from April 1, 2013 to February 7, 2018 at the same center. The success rates of induction were 79.4% (135/170) without placebo and 73.5% (125/170) with placebo. The difference of these two proportions was 5.9%, with two‐sided 95% confidence interval ranging from −3.6% to 15.2%, indicating a non–statistically significant difference. The lower bound of the 95% confidence interval (−3.6%) was above the noninferiority margin (δ = −5%), hence inferring noninferiority of induction without versus with placebo. The greater cumulative induction experiences of the clinician performer (influencing the manner/presentation of induction) may supplant the potential advantage from addition of placebo (the means utilized). Among experienced performers, provocative induction without placebo should be the preferred diagnostic approach, given more ethically acceptable transparency and the noninferior success rate when compared to the same induction technique with placebo.
IntroductionPost-stroke depression (PSD) is a severe complication of cerebrovascular stroke affecting about one-third of stroke survivors. Moreover, PSD is associated with functional recovery and quality of life (QOL) in stroke survivors. Screening for PSD is recommended. There are, however, differences in the literature on the impact of early screening on functional outcomes. In this systematic review, we synthesise the currently available literature regarding the associations between timing and setting of PSD screening and mortality, QOL and functional outcomes in stroke survivors.Methods and analysisWe will systematically search electronic databases including PubMed, Embase, APA PsycINFO, Web of Science, Scopus and CINAHL from inception to August 2021. Four reviewers will screen the title and abstract and full-text level records identified in the search in a blinded fashion to determine the study eligibility. Any selection disagreements between the reviewers will be resolved by the study investigator. Data extraction of eligible studies will be conducted by two reviewers using a predefined template. We will complete the quality assessment of included articles independently by two reviewers using the Newcastle Ottawa Scale. Eventual discrepancies will be resolved by the principal investigator.Ethics and disseminationDue to the nature of the study design, ethical approval is not required. The systematic review and meta-analysis findings will be published and disseminated in a peer-reviewed journal. Our results will also be disseminated through posters and presentations at appropriate scientific conferences.PROSPERO registration numberCRD42021235993.
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