Introduction of SFR and RPS was associated with significant reduction in NEC ≥ Stage II and the composite outcome of NEC ≥ Stage II /mortality in preterm infants.
ObjectivesPublished negative studies should have the same rigour of methodological quality as studies with positive findings. However, the methodological quality of negative versus positive studies is not known. The objective was to assess the reported methodological quality of positive versus negative studies published in Indian medical journals.DesignA systematic review (SR) was performed of all comparative studies published in Indian medical journals with a clinical science focus and impact factor >1 between 2011 and 2013. The methodological quality of randomised controlled trials (RCTs) was assessed using the Cochrane risk of bias tool, and the Newcastle-Ottawa scale for observational studies. The results were considered positive if the primary outcome was statistically significant and negative otherwise. When the primary outcome was not specified, we used data on the first outcome reported in the history followed by the results section. Differences in various methodological quality domains between positive versus negative studies were assessed by Fisher's exact test.ResultsSeven journals with 259 comparative studies were included in this SR. 24% (63/259) were RCTs, 24% (63/259) cohort studies, and 49% (128/259) case–control studies. 53% (137/259) of studies explicitly reported the primary outcome. Five studies did not report sufficient data to enable us to determine if results were positive or negative. Statistical significance was determined by p value in 78.3% (199/254), CI in 2.8% (7/254), both p value and CI in 11.8% (30/254), and only descriptive in 6.3% (16/254) of studies. The overall methodological quality was poor and no statistically significant differences between reporting of methodological quality were detected between studies with positive versus negative findings.ConclusionsThere was no difference in the reported methodological quality of positive versus negative studies. However, the uneven reporting of positive versus negative studies (72% vs 28%) indicates a publication bias in Indian medical journals with an impact factor of >1.
Transdermal drug delivery system (TDDS) is the topically administered medication, which when applied to the skin, delivers the drug through the skin for systemic effect at a predetermined and controlled rate. For the drugs, having short biological half life, transdermal drug delivery system is convenient. It overcome the problems like the hepatic first pass effect, improves the compliance of patients, decreases the administration frequency, and reduce the gastrointestinal side effects , peak and valley levels in the blood are avoided. Due to have an advantage of being non-invasive, this delivery has to fulfill some parameters such as high potency, better permeability through skin and non-irritation for better compliance. Skin serves as a site of drug application for local effect as well as systemic effect. There are wide varieties of drugs for which topical or transdermal is a viable option, skin penetration enhancement techniques have been developed for such drugs. There are a number of physical methods to increase drug delivery via the skin, many of which require the use of devices and some of which hold the promise to significantly expand the spectrum of drugs that can be administered transdermally to include water-soluble molecules and macromolecules. Iontophoresis and electroporation represent electrically assisted, physical approaches to enhance delivery of drugs/macromolecules across the stratum corneum. This review highlights the detailed role of physical penetration and describes their mechanism of action.
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