182 research outputs found
Impact of CONSORT extension for cluster randomised trials on quality of reporting and study methodology : review of random sample of 300 trials, 2000-8
Peer reviewedPublisher PD
Inadequate reporting of research ethics review and informed consent in cluster randomized trials : review of random sample of published trials
Peer reviewedPublisher PD
Variability in research ethics review of cluster randomized trials: a scenario-based survey in three countries
Electronic search strategies to identify reports of cluster randomized trials in MEDLINE: low precision will improve with adherence to reporting standards
BACKGROUND: Cluster randomized trials (CRTs) present unique methodological and ethical challenges. Researchers conducting systematic reviews of CRTs (e.g., addressing methodological or ethical issues) require efficient electronic search strategies (filters or hedges) to identify trials in electronic databases such as MEDLINE. According to the CONSORT statement extension to CRTs, the clustered design should be clearly identified in titles or abstracts; however, variability in terminology may make electronic identification challenging. Our objectives were to (a) evaluate sensitivity ( recall ) and precision of a well-known electronic search strategy ( randomized controlled trial as publication type) with respect to identifying CRTs, (b) evaluate the feasibility of new search strategies targeted specifically at CRTs, and (c) determine whether CRTs are appropriately identified in titles or abstracts of reports and whether there has been improvement over time.
METHODS: We manually examined a wide range of health journals to identify a gold standard set of CRTs. Search strategies were evaluated against the gold standard set, as well as an independent set of CRTs included in previous systematic reviews.
RESULTS: The existing strategy (randomized controlled trial.pt) is sensitive (93.8%) for identifying CRTs, but has relatively low precision (9%, number needed to read 11); the number needed to read can be halved to 5 (precision 18.4%) by combining with cluster design-related terms using the Boolean operator AND; combining with the Boolean operator OR maximizes sensitivity (99.4%) but would require 28.6 citations read to identify one CRT. Only about 50% of CRTs are clearly identified as cluster randomized in titles or abstracts; approximately 25% can be identified based on the reported units of randomization but are not amenable to electronic searching; the remaining 25% cannot be identified except through manual inspection of the full-text article. The proportion of trials clearly identified has increased from 28% between the years 2000-2003, to 60% between 2004-2007 (absolute increase 32%, 95% CI 17 to 47%).
CONCLUSIONS: CRTs should include the phrase cluster randomized trial in titles or abstracts; this will facilitate more accurate indexing of the publication type by reviewers at the National Library of Medicine, and efficient textword retrieval of the subset employing cluster randomization
A multidisciplinary study of a small, temporarily open/closed South African estuary, with particular emphasis on the influence of mouth state on the ecology of the system
In 2005/2006 a multidisciplinary research programme that included studies on the hydrodynamics, sediment dynamics, macronutrients, microalgae, macrophytes, zoobenthos, hyperbenthos, zooplankton, ichthyoplankton, fish and birds of the temporarily open/closed East Kleinemonde Estuary was conducted. Particular attention was given to the responses of the different ecosystem components to the opening and closing of the estuary mouth and how this is driven by both riverine and marine events. Using a complementary dataset of daily estuary mouth conditions spanning a 14-year period, five distinct phases of the estuary were identified, including closed (average = 90% of the days), outflow (<1%), tidal (9%) and semi-closed (<1%). The open-mouth phase is critical for the movements of a number of estuary-associated fish (e.g. Rhabdosargus holubi) and invertebrates (e.g. Scylla serrata) between the estuary and sea. The timing of this open phase has a direct influence on the ability of certain estuaryassociated fish (e.g. Lithognathus lithognathus) and invertebrates (e.g. Palaemon peringueyi) to successfully recruit into the system, with a spring opening (October/November) being regarded as optimal for most species. The type of mouth-breaching event and outflow phase is also important in terms of the subsequent salinity regime once the berm barrier forms. A deep mouth breaching following a large river flood tends to result in major tidal inputs of marine water prior to mouth closure and therefore higher salinities (15–25). Conversely, a shallow mouth breaching with reduced tidal exchange during the open phase often leads to a much lower salinity regime at the time of mouth closure (5–15). The biota, especially the submerged macrophytes, respond very differently to the above two scenarios, with Ruppia cirrhosa benefiting from the former and Potamogeton pectinatus from the latter. River flooding and the associated outflow of large volumes of water through the estuary can result in major declines in zooplankton, zoobenthos, hyperbenthos and fish populations during this phase. However, this resetting of the estuary is necessary because certain marine invertebrate and fish species are dependent on the opening of the estuary mouth in order to facilitate recruitment of larvae and post-larvae into the system from the sea. Slight increases in the numbers of certain piscivorous and resident wading bird species were recorded when the estuary mouth opened, possibly linked to increased feeding opportunities during that phase
Does clinical equipoise apply to cluster randomized trials in health research?
This article is part of a series of papers examining ethical issues in cluster randomized trials (CRTs) in health research. In the introductory paper in this series, Weijer and colleagues set out six areas of inquiry that must be addressed if the cluster trial is to be set on a firm ethical foundation. This paper addresses the third of the questions posed, namely, does clinical equipoise apply to CRTs in health research? The ethical principle of beneficence is the moral obligation not to harm needlessly and, when possible, to promote the welfare of research subjects. Two related ethical problems have been discussed in the CRT literature. First, are control groups that receive only usual care unduly disadvantaged? Second, when accumulating data suggests the superiority of one intervention in a trial, is there an ethical obligation to act
Revival of the magnetar PSR J1622-4950: observations with MeerKAT, Parkes, XMM-Newton, Swift, Chandra, and NuSTAR
New radio (MeerKAT and Parkes) and X-ray (XMM-Newton, Swift, Chandra, and
NuSTAR) observations of PSR J1622-4950 indicate that the magnetar, in a
quiescent state since at least early 2015, reactivated between 2017 March 19
and April 5. The radio flux density, while variable, is approximately 100x
larger than during its dormant state. The X-ray flux one month after
reactivation was at least 800x larger than during quiescence, and has been
decaying exponentially on a 111+/-19 day timescale. This high-flux state,
together with a radio-derived rotational ephemeris, enabled for the first time
the detection of X-ray pulsations for this magnetar. At 5%, the 0.3-6 keV
pulsed fraction is comparable to the smallest observed for magnetars. The
overall pulsar geometry inferred from polarized radio emission appears to be
broadly consistent with that determined 6-8 years earlier. However, rotating
vector model fits suggest that we are now seeing radio emission from a
different location in the magnetosphere than previously. This indicates a novel
way in which radio emission from magnetars can differ from that of ordinary
pulsars. The torque on the neutron star is varying rapidly and unsteadily, as
is common for magnetars following outburst, having changed by a factor of 7
within six months of reactivation.Comment: Published in ApJ (2018 April 5); 13 pages, 4 figure
Applying quantitative bias analysis to estimate the plausible effects of selection bias in a cluster randomised controlled trial: secondary analysis of the Primary care Osteoarthritis Screening Trial (POST)
Acceptability of Male Circumcision for the Prevention of HIV/AIDS in the Dominican Republic
Male circumcision (MC) is an effective strategy to prevent HIV infection in heterosexual men. To our knowledge, there are no studies of the acceptability of this procedure in the Dominican Republic (DR). The main objective of this study was to assess the acceptability of MC to prevent HIV transmission among men ages 18 to 50 years in the Altagracia Province in the Dominican Republic. Because differences in culture and beliefs between Haitians and Dominicans could potentially influence their acceptability of MC, we conducted a comparative analysis based on national origin.A survey was administered to a convenience sample of 368 men. The questionnaire was divided in 3 sections: 1) Background demographics (including national origin), 2) Male circumcision and 3) Sexual health. Stratified and logistic multivariate regression analyses were performed to identify factors associated with the acceptability of MC.The sample consisted of 238 (65%) Dominicans and 130 (35%) Haitian immigrants. Almost all participants were uncircumcised (95%) and about half (52%) were single. The overall acceptability of MC was 29%. The number of men willing to be circumcised increased to 67% after an information session explaining the benefits of the procedure. 74% of men reported that they would be willing to circumcise their sons after hearing that information. In multivariate analysis, Haitian nationality (OR=1.86, 95% CI 1.01-3.41), knowing that circumcision improves hygiene (OR=2.78, 95% CI 1.29-6.0) and not believing that circumcision decreases sexual pleasure (OR=2.18, 95% CI 1.20-3.94) were associated with a higher acceptability of the procedure. Although age was not significantly associated with the willingness to be circumcised in the multivariate analysis, stratified analysis based on national origin suggested that younger Dominicans (<30 years of age) are more likely to accept the procedure when compared to their older counterparts (OR=2.17, 95% CI 1.14-4.12).An important number of sexually active men in the DR may be willing to be circumcised if educational resources detailing the benefits of the procedure are made available. These educational activities would constitute a great opportunity to teach about sexual health and reinforce safe sex practices
A point-prevalence study of body mass indices in HIV-positive and HIV-negative patients admitted to hospital with COVID-19 in South Africa
Background. Obesity is now well recognised as a risk factor for severe COVID‐19, but the true prevalence of obesity in hospitalised adults with COVID‐19 remains unclear because formal body mass indices (BMIs) are not routinely measured on admission.
Objectives. To describe the true prevalence of obesity measured by the BMI, and associated comorbidities, in patients hospitalised with severe COVID‐19, including people with HIV (PWH).
Methods. We conducted a point‐prevalence study of measured BMI in consecutive patients with severe COVID‐19 admitted to the medical COVID‐19 wards in a tertiary academic hospital in Cape Town, South Africa (SA). Patients were enrolled over a 2‐week period during the peak of the first COVID‐19 wave in SA.
Results. We were able to measure the BMI in 122 of the 146 patients admitted during the study period. The prevalence of HIV was 20% (n=24/122). Most of the participants were overweight or obese (n=104; 85%), and 84 (68.9%) met criteria for obesity. The mean (standard deviation) BMI was 33 (7.5), and 34.5 (9.1) in PWH. Of PWH, 83% (n=20/24) were overweight or obese and 75% (n=18) met criteria for obesity. Multimorbidity was present in 22 (92%) of PWH.
Conclusion. We found that most patients, including PWH, met criteria for being overweight or obese. The high prevalence of obesity in PWH and severe COVID‐19 reinforces the need for targeted management of non‐communicable diseases, including obesity, in PWH
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