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  • Pancreas 01/2014; 43(1):141-2. DOI:10.1097/MPA.0b013e31829fcf35
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    ABSTRACT: An antidote to inadequate reporting of research
    BMJ (online) 08/2013; 347(aug07 3):f4796. DOI:10.1136/bmj.f4796
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    ABSTRACT: Reports of randomized controlled trials (RCTs) inform the care of future patients and are especially important to clinicians and systematic reviewers. Readers should satisfy themselves that the study methods were sound. Clinicians should consider the relevance to their own patients, both benefits and harms, and absolute as well as relative effects. Trial reports should provide a clear, transparent, and complete report of what was done and what was found. Unfortunately, bad reporting of RCTs is common, which has serious consequences for clinical practice, research, policy making, and ultimately for patients. RCT reports should adhere to the CONSORT Statement, a minimum set of items that should be addressed. Authors, peer reviewers, and editors should all work to ensure that research reports maximize the value derived from the cost and effort of conducting a trial.
    The American Journal of Gastroenterology 08/2013; 108(8):1231-5. DOI:10.1038/ajg.2012.457
  • BJOG An International Journal of Obstetrics & Gynaecology 07/2013; 120(8):1036-8. DOI:10.1111/1471-0528.12361
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    ABSTRACT: BACKGROUND: Vascular dementia represents the second most common type of dementia after Alzheimer's disease. In older patients, in particular, the combination of vascular dementia and Alzheimer's disease is common, and is referred to as mixed dementia. The classification of vascular dementia broadly follows three clinico-pathological processes: multi-infarct dementia, single strategic infarct dementia and subcortical dementia. Not all victims fulfil strict criteria for dementia and may be significantly cognitively impaired without memory loss, when the term vascular cognitive impairment (VCI) is more useful. Currently, no established standard treatment for VCI exists. Reductions in acetylcholine and acetyltransferase activity are common to both Alzheimer's disease and VCI, raising the possibility that cholinesterase inhibitors - such as rivastigmine - which are beneficial in Alzheimer's disease, may also be beneficial for VCI. OBJECTIVES: To assess the efficacy of rivastigmine compared with placebo in the treatment of people with vascular cognitive impairment (VCI), vascular dementia or mixed dementia. SEARCH METHODS: We searched ALOIS (the Cochrane Dementia and Cognitive Improvement Group's Specialized Register) on 12 February 2013 using the terms: rivastigmine, exelon, "SDZ ENA 713". ALOIS contains records of clinical trials identified from monthly searches of a number of major healthcare databases (The Cochrane Library, MEDLINE, EMBASE, CINAHL, PsycINFO, LILACS), numerous trial registries and grey literature sources. SELECTION CRITERIA: All unconfounded randomized double-blind trials comparing rivastigmine with placebo in the treatment of people with VCI, vascular dementia or mixed dementia were eligible for inclusion. DATA COLLECTION AND ANALYSIS: Two reviewers extracted and assessed data independently, and agreement was reached after discussion. They noted results concerning adverse effects. MAIN RESULTS: Three trials, with a total of 800 participants, were identified for inclusion. The participants in one trial did not have dementia, while the other two studies included participants with dementia of different severities. The dose of rivastigmine was different in each study. No pooling of study results was attempted because of these differences between the studies.One trial included 40 participants with subcortical vascular dementia (age range 40 to 90 years) with a mean mini-mental state examination (MMSE) score of 13.0 and 13.4 in the rivastigmine and placebo arms, respectively. Treatment over 26 weeks was limited to 3 mg rivastigmine twice daily, or placebo. No significant difference was found on any outcome measure relevant to cognition, neuropsychiatric symptoms, function or global rating, or in the number of withdrawals before the end of treatment.Another trial included 710 participants with vascular dementia, including subcortical and cortical forms (age range 50 to 85 years). Over 24 weeks, a mean dose of rivastigmine of 9.4 mg/day was achieved versus placebo. Baseline MMSE was identical for both groups, at 19.1. Statistically significant advantage in cognitive response (but not with global impression of change or non-cognitive measures) was seen with rivastigmine treatment at 24 weeks (MMSE change from baseline MD 0.6, 95% CI 0.11 to 1.09, P value 0.02; Vascular Dementia Assessment Scale (VaDAS) change from baseline MD -1.3, 95% CI-2.62 to 0.02, P value 0.05 ). Significantly higher rates of vomiting, nausea, diarrhoea and anorexia and withdrawals from treatment were noted in the participants randomized to rivastigmine compared with placebo (withdrawals rivastigmine 90/365, placebo 48/345, OR 2.02, 95% CI 1.38 to 2.98) (withdrawals due to an adverse event rivastigmine 49/365, placebo 19/345, OR 2.66, 95% CI 1.53 to 4.62, P value 0.0005).The third study included 50 participants (age range 48 to 84 years) with mean MMSE scores of 23.7 and 23.9 in the rivastigmine and placebo arms, respectively. Over a 24-week period, participants labelled as having cognitive impairment but no dementia (CIND) following ischaemic stroke were given up to 4.5 mg rivastigmine twice daily, or placebo. Primary and secondary outcome measures showed no statistically significant difference when considering neurocognitive abilities, function, neuropsychiatric symptoms and global performance. One participant in the rivastigmine group and two in the placebo group discontinued their medication because of an adverse effect. AUTHORS' CONCLUSIONS: There is some evidence of benefit of rivastigmine in VCI from trial data from three studies. However, this conclusion is based on one large study. Rivastigmine is capable of inducing side effects that lead to withdrawal in a significant proportion of patients.
    Cochrane database of systematic reviews (Online) 06/2013; 5(5):CD004744. DOI:10.1002/14651858.CD004744.pub3
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    BJOG An International Journal of Obstetrics & Gynaecology 06/2013; 120(7):908-10. DOI:10.1111/1471-0528.12277
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    ABSTRACT: The INTERGROWTH-21st Project has in its mandate to develop prescriptive standards for fetal, neonatal and preterm post-neonatal growth. The project comprises three components: the Fetal Growth Longitudinal Study (FGLS), the Preterm Postnatal Follow-up Study (PPFS), and the Newborn Cross-Sectional Study (NCSS). We consider here the statistical aspects of the three components as they relate to the construction of these standards, in particular the sample size, and outline the principles that will guide the planned main analyses.
    British Journal of Obstetrics and Gynaecology 05/2013; 120(s2). DOI:10.1111/1471-0528.12031
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    ABSTRACT: Accurate, complete and timely publication of research studies is an integral part of a responsible research conduct. Following the reporting guidelines helps in preparing high quality research papers, facilitates peer review, and increases the chances of paper acceptance by a suitable journal. The EQUATOR Network website (www.equator-network.org) provides a collection of reporting guidelines and other resources helping researchers to publish their research studies.
    International Journal of Clinical Practice 05/2013; 67(8). DOI:10.1111/ijcp.12168
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    ABSTRACT: To carry out a systematic review of recently published large-scale observational studies assessing the effects of red blood cell transfusion (RBCT) on mortality, with particular emphasis on the statistical methods used to adjust for confounding. Given the limited number of randomised trials of the efficacy of RBCT, clinicians often use evidence from observational studies. However, confounding factors, for example, individuals receiving blood generally being sicker than those who do not, make their interpretation challenging. Systematic review. We searched MEDLINE and EMBASE for studies published from 1 January 2006 to 31 December 2010. ELIGIBILITY CRITERIA FOR INCLUDED STUDIES: We included prospective cohort, case-control studies or retrospective analyses of databases or disease registers where the effect of risk factors for mortality or survival was examined. Studies must have included more than 1000 participants receiving RBCT for any cause. We assessed the effects of RBCT versus no RBCT and different volumes and age of RBCT. -32 studies were included in the review; 23 assessed the effects of RBCT versus no RBCT; 5 assessed different volumes and 4 older versus newer RBCT. There was a considerable variability in the patient populations, study designs and level of statistical adjustment. Overall, most studies showed a higher rate of mortality when comparing patients who received RBCT with those who did not, even when these rates were adjusted for confounding; the majority of these increases were statistically significant. The same pattern was observed in studies where protection from bias was likely to be greater, such as prospective studies. Recent observational studies do show a consistently adverse effect of RBCT on mortality. Whether this is a true effect remains uncertain as it is possible that even the best conducted adjustments cannot completely eliminate the impact of confounding.
    BMJ Open 05/2013; 3(5). DOI:10.1136/bmjopen-2012-002154
  • BJOG An International Journal of Obstetrics & Gynaecology 05/2013; 120(6):787-9. DOI:10.1111/1471-0528.12249
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