The involvement of non‐researcher contributors (eg, stakeholders, patients and the public, decision and policy makers, experts, lay contributors) has taken a variety of forms within evidence syntheses. Realist reviews are a form of evidence synthesis that involves non‐researcher contributors yet this practice has received little attention. In particular, the role of patient and public involvement (PPI) has not been clearly documented. This review of reviews describes the ways in which contributor involvement, including PPI, is documented within healthcare realist reviews published over the last five years. A total of 448 papers published between 2014 and 2019 were screened, yielding 71 full‐text papers included in this review. Statements about contributor involvement were synthesized across each review using framework analysis. Three themes are described in this article including nomenclature, nature of involvement, and reporting impact. Papers indicate that contributor involvement in realist reviews refers to stakeholders, experts, or advisory groups (ie, professionals, clinicians, or academics). Patients and the public are occasionally subsumed into these groups and in doing so, the nature and impact of their involvement become challenging to identify and at times, is lost completely. Our review findings indicate a need for the realist review community to develop guidance to support researchers in their future collaboration with contributors, including patients and the public.
Background Patients with anorexia nervosa (AN) are at higher risk of sudden cardiac death. Although the underlying aetiology for this association remains unclear. It may be related to prolongation of the QT interval, which can degenerate into fatal ventricular arrhythmias. However, the presence of prolonged heart rate-corrected QT interval (QTc) in AN remains controversial, and two previous meta-analyses on AN and QTc showed contradictory findings [1,2]. Purpose In this systematic review and meta-analysis, we aimed to evaluate if AN was associated with changes in the QTc interval and dispersion. Methods MEDLINE, EMBASE and COCHRANE databases were systematically searched from inception to January 2021. Random-effects meta-analysis and meta-regression were used. The inclusion criteria were (i) confirmed diagnosis of AN, (ii) measurement of QTc on electrocardiogram and (iii) peer-reviewed articles. The primary endpoint of the study was the duration of the QTc interval calculated using the Bazett (QTcB), Hodges (QTcH), Fridericia (QTcF) and Framingham (QTcFr) formulae. The secondary endpoints were QT dispersion (QTd) and QTc dispersion (QTcd). Results The 25 eligible studies included 5687 patients (1862 AN, 3825 control) (Figure 1: PRISMA diagram). The majority of patients were female (96.3%) with a mean age between 14.3 to 31.0 years and mean duration of disease ranging from 9.1 to 129.6 months. The mean BMI ranged from 13.7 to 18.5 kg/m2. Pooled analysis did not show significant prolongation between AN versus control in QTcB (mean difference (MD) MD 4.9ms, 95% CI −3.2, 13.1ms, p=0.23; I2=95%; n=24/25 studies; Figure 2A), QTcH (MD 1.3ms, 95% CI −8.5, 11.2ms, p=0.79; I2=71%; n=3/25 studies), and QTcF (MD 3.1ms, 95% CI −21.6, 27.7ms, p=0.81; I2=97%; n=3/25 studies). Only two studies reporting QTcFr showed a significant prolongation between AN and control (MD 15.9ms, 95% CI 0.0, 31.8ms, p=0.05, I2=65%; n=2/25 studies; Figure 2B). However, QTd and QTcd were significantly greater in AN than control (MD 21.3ms, 95% CI 10.4, 32.3ms, p=0.0001, I2=94%; Figure 2C and MD 16.9ms, 95% CI 4.5, 29.3ms, p=0.007 I2=93%; Figure 2D, respectively). Conclusion To the best of our knowledge, this is the largest meta-analysis of QTc in AN and the first meta-analysis exploring the significance of QTd and QTcd in AN. AN was not found to be associated with prolongation of QTc calculated using the Bazett, Fridericia and Hodges formulae. However, an association of AN with prolonged QTc was observed in the studies using the Framingham formula. More pronounced dispersion (QTd and QTcd) was also observed in patients with AN. Funding Acknowledgement Type of funding sources: None.
In this paper, we are going to discuss the 'Active Air Sampling procedure for EM'. EM stands for Environment Monitoring. Environment monitoring is performed in the pharmaceutical manufacturing plants to monitor the contamination of viable and non-viable particle count. Viable particle count can be observed through the 'Settle Plate method, Active Air Sampling, Surface Monitoring (contact plate & swab test), and Personnel Monitoring method'. Non-viable particles are dust particles and other non-living particles. Active Air sampling is performed by microbiologist in the production & manufacturing area using the equipment known as 'Air Sampler'. A media plate of SCDA (Soybean-Casein Digest Agar) prepared under sterile condition by the microbiologist. The media plate is then allowed to adjust under the 'Air Sampler hood' and then it is used for sampling purpose. Air sampler captures 1000L air as per validated time in a 1cubic meter of volume and therefore air sampling is thus performed in the middle of the surrounding area. The sampled plate is then incubated, and after then the required incubation is provided, and the plate is thus analyzed to determine whether our manufacturing area meets the level of expected counts or it crosses the required limit; and, on this basis, the reporting is thus generated on regular basis.
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