F1000Research
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Background: Cardiac arrest requires rapid and effective handling. Huge efforts have been implemented to improve resuscitation of sudden cardiac arrest patients. Guidelines around the various parts of effective management, the chain of survival, are available. ⋯ CPC score was available for 188 out of the 195 patients that were alive to be discharged: 96.5% of patients where data was available had a favourable neurological outcome, a CPC-score of 1 or 2 at discharge, and only 6 of these patients had a CPC-score of 3 or higher (3%). Conclusions: One third of patients with sudden IHCA were discharged from hospital and alive at day-30, a clear majority without cognitive deficit related to the cardiac arrest. High monitored care, witnessed cardiac arrest and shockable rhythm were factors associated with high success; however, more than half of surviving patients had initially a none-shockable rhythm.
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Stakeholders in healthcare are increasingly turning to real world evidence (RWE) to inform their decisions, alongside evidence from randomized controlled trials. RWE is generated by analysing data gathered from routine clinical practice, and can be used across the product lifecycle, providing insights into areas including disease epidemiology, treatment effectiveness and safety, and health economic value and impact. Recently, the US Food and Drug Administration and the European Medicines Agency have stated their ambition for greater use of RWE to support applications for new indications, and are now consulting with their stakeholders to formalize standards and expected methods for generating RWE. ⋯ Senior pharmaceutical leaders can drive this change by making RWE a core element of their corporate strategy, providing top-level direction on how their respective companies should approach RWE for maximum quality. Here, we describe the current and future areas of RWE application within the pharmaceutical industry, necessary access to data to generate RWE, and the challenges in communicating RWE. Supporting and building on viewpoints from industry and publicly funded research, our perspective is that at each stage of RWE generation, quality will be critical to the impact that RWE has on healthcare decision-makers; not only where RWE is an established and evolving tool, but also in new areas that have the potential to disrupt and to improve drug development pathways.
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Background: Use of an in situ epidural catheter has been suggested to be efficient to provide anesthesia for postpartum tubal ligation (PPTL). Reported epidural reactivation success rates vary from 74% to 92%. Predictors for reactivation failure include poor patient satisfaction with labor analgesia, increased delivery-to-reactivation time and the need for top-ups during labor. ⋯ Conclusions: Our observed rate of successful postpartum epidural reactivation for tubal ligation was lower than the range reported in the literature. Our success rates for both spinal anesthesia and epidural reactivation for PPTL were lower than the generally accepted rates of successful epidural and spinal anesthesia for cesarean delivery. This gap may reflect a lower level of motivation on behalf of both the patients and anesthesia providers to tolerate "imperfect" neuraxial anesthesia once fetal considerations are removed.
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Background: The PMD100™ (Medasense Biometrics Ltd., Ramat Yishai, Israel) is a novel non-invasive nociception monitor that integrates physiological parameters to compute a real-time nociception level index (NOL) in the anesthetized patients. Thoracic epidural analgesia provides effective analgesia and improves surgical outcomes. Side effects include sympathectomy, hypotension, changes in skin temperature and a decreased cardiac accelerator fiber tone. ⋯ The area under the curve of delta NOL and delta HR variations after incision were significantly different (p<0.05) between groups and delta NOL variations were significantly different from baseline values but not the delta HR variations. Conclusions: This pilot study suggests that the PMD100™ Monitor may be a useful tool to evaluate the efficacy of an intraoperative thoracic epidural analgesia. Clinical Trial Registry Number: ClinicalTrials.gov record ID: NCT01978379 registered 10/25/2014.
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Considerations related to vaping as a possible gateway into cigarette smoking: an analytical review.
Background: Compared to cigarette smoking, e-cigarette use is likely to present a reduced risk of smoking-related disease (SRD). However, several studies have shown that vaping predicts smoking initiation and might provide a gateway into smoking for those who otherwise would never have smoked. This paper considers various aspects of the gateway issue in youths. ⋯ We also present arguments suggesting that even with some true gateway effect, introducing e-cigarettes likely reduces SRD risk. Conclusions: A true gateway effect in youths has not yet been demonstrated. Even if it were, e-cigarette introduction may well have had a beneficial population health impact.