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TIDieR-Placebo: A guide and checklist for reporting placebo and sham controls
Placebo or sham controls are the standard against which the benefits and harms of many active interventions are measured. Whilst the components and the method of their delivery have been shown to affect study outcomes, placebo and sham controls are rarely reported and often not matched to those of the active comparator. This can influence how beneficial or harmful the active intervention appears to be. Without adequate descriptions of placebo or sham controls, it is difficult to interpret results about the benefits and harms of active interventions within placebo-controlled trials. To overcome this problem, we developed a checklist and guide for reporting placebo or sham interventions.
We developed an initial list of items for the checklist by surveying experts in placebo research (n = 14). Because of the diverse contexts in which placebo or sham treatments are used in clinical research, we consulted experts in trials of drugs, surgery, physiotherapy, acupuncture, and psychological interventions. We then used a multistage online Delphi process with 53 participants to determine which items were deemed to be essential. We next convened a group of experts and stakeholders (n = 16). Our main output was a modification of the existing Template for Intervention Description and Replication (TIDieR) checklist; this allows the key features of both active interventions and placebo or sham controls to be concisely summarised by researchers. The main differences between TIDieR-Placebo and the original TIDieR are the explicit requirement to describe the setting (i.e., features of the physical environment that go beyond geographic location), the need to report whether blinding was successful (when this was measured), and the need to present the description of placebo components alongside those of the active comparator.
We encourage TIDieR-Placebo to be used alongside TIDieR to assist the reporting of placebo or sham components and the trials in which they are used.
Journal Article
Delirium detection in older acute medical inpatients: a multicentre prospective comparative diagnostic test accuracy study of the 4AT and the confusion assessment method
Background
Delirium affects > 15% of hospitalised patients but is grossly underdetected, contributing to poor care. The 4 ‘A’s Test (4AT,
www.the4AT.com
) is a short delirium assessment tool designed for routine use without special training. The primary objective was to assess the accuracy of the 4AT for delirium detection. The secondary objective was to compare the 4AT with another commonly used delirium assessment tool, the Confusion Assessment Method (CAM).
Methods
This was a prospective diagnostic test accuracy study set in emergency departments or acute medical wards involving acute medical patients aged ≥ 70. All those without acutely life-threatening illness or coma were eligible. Patients underwent (1) reference standard delirium assessment based on DSM-IV criteria and (2) were randomised to either the index test (4AT, scores 0–12; prespecified score of > 3 considered positive) or the comparator (CAM; scored positive or negative), in a random order, using computer-generated pseudo-random numbers, stratified by study site, with block allocation. Reference standard and 4AT or CAM assessments were performed by pairs of independent raters blinded to the results of the other assessment.
Results
Eight hundred forty-three individuals were randomised: 21 withdrew, 3 lost contact, 32 indeterminate diagnosis, 2 missing outcome, and 785 were included in the analysis. Mean age was 81.4 (SD 6.4) years. 12.1% (95/785) had delirium by reference standard assessment, 14.3% (56/392) by 4AT, and 4.7% (18/384) by CAM. The 4AT had an area under the receiver operating characteristic curve of 0.90 (95% CI 0.84–0.96). The 4AT had a sensitivity of 76% (95% CI 61–87%) and a specificity of 94% (95% CI 92–97%). The CAM had a sensitivity of 40% (95% CI 26–57%) and a specificity of 100% (95% CI 98–100%).
Conclusions
The 4AT is a short, pragmatic tool which can help improving detection rates of delirium in routine clinical care.
Trial registration
International standard randomised controlled trial number (ISRCTN)
53388093
. Date applied 30/05/2014; date assigned 02/06/2014.
Journal Article
Amphibians and reptiles of the state of Chihuahua, Mexico, with comparisons with adjoining states
Chihuahua is Mexico’s largest state, and its physiographic complexity affects the distribution of its herpetofauna. We list amphibians and reptiles for the state of Chihuahua, with their conservation status. We also compare this list to those of six adjoining states in the United States and Mexico (New Mexico, Texas, Coahuila, Durango, Sinaloa, and Sonora). A total of 175 species of amphibians and reptiles is found in Chihuahua. Thirty-eight are amphibians, and 137 reptiles. Chihuahuan amphibians and reptiles represent just over 37% of such species from Chihuahua and neighboring states. Chihuahua shares the highest proportion of its herpetofauna with Sonora and Durango. Most of the herpetofauna of Chihuahua falls in IUCNs least concern category and is not listed by SEMARNAT. However, turtles in Chihuahua are a group of particular conservation concern.
Journal Article
New records of Helophoridae, Hydrochidae, and Hydrophilidae (Coleoptera) from New Brunswick, Canada
The following three species of Helophoridae are newly recorded for New Brunswick, Canada: Helophorus (Kyphohelophorus) turberculatus Gyllenhal, Helophorus (Rhopaleloporus) oblongus LeConte, Helophorus (Rhopaleloporus) marginicollis Smetana. Hydrochus
subcupreus Randall, family Hydrochidae, and the following 15 species of Hydrophilidae are newly reported for the province: Berosus
fraternus LeConte, Berosus
peregrinus (Herbst), Berosus
sayi Hansen, Paracymus
despectus (LeConte), Chaetarthria
atra (LeConte), Cymbiodyta
acuminata Fall, Cymbiodyta
blanchardi Horn, Cymbiodyta
minima Notman, Enochrus (Lumetus) hamiltoni Horn, Enochrus (Methydrus) consors (LeConte), Enochrus (Methydrus) consortus Green, Enochrus (Methydrus) pygmaeus
nebulosus (Say), Cercyon (Cercyon) cinctus Smetana, Cercyon (Cercyon) herceus
frigidus Smetana, Cercyon (Dicyrtocercyon) ustulatus (Preyssler).
Journal Article
A checklist of helminth parasites of Elasmobranchii in Mexico
A comprehensive and updated summary of the literature and unpublished records contained in scientific collections on the helminth parasites of the elasmobranchs from Mexico is herein presented for the first time. At present, the helminth fauna associated with Elasmobranchii recorded in Mexico is composed of 132 (110 named species and 22 not assigned to species), which belong to 70 genera included in 27 families (plus 4 incertae sedis families of cestodes). These data represent 7.2% of the worldwide species richness. Platyhelminthes is the most widely represented, with 128 taxa: 94 of cestodes, 22 of monogeneans and 12 of trematodes; Nematoda and Annelida: Hirudinea are represented by only 2 taxa each. These records come from 54 localities, pertaining to 15 states; Baja California Sur (17 sampled localities) and Baja California (10), are the states with the highest species richness: 72 and 54 species, respectively. Up to now, 48 elasmobranch species have been recorded as hosts of helminths in Mexico; so, approximately 82% of sharks and 67% of rays distributed in Mexican waters lack helminthological studies. The present list provides the host, distribution (with geographical coordinates), site of infection, accession number in scientific collections, and references for the parasites. A host-parasite list is also provided.
Journal Article
Additions to the checklist of Scoliidae, Sphecidae, Pompilidae and Vespidae of Peru, with notes on the endemic status of some species (Hymenoptera, Aculeata)
The first checklist of the Peruvian Hymenoptera listed 1169 species and subspecies of aculeate wasps, including 173 species of Pompilidae, seven of Scoliidae, 39 of Sphecidae and 403 of Vespidae. Herein are reported 32 species as new for Peru based mainly on the collection of the Natural History Museum, London. The loss of the endemic status of two species is also reported: Entypus
peruvianus (Rohwer) (Pompilidae: Pepsinae) and Omicron
ruficolle
schunkei Giordani Soika (Vespidae: Eumeninae).
Journal Article
Checklist for the crop weeds of Paraguay
Paraguay, a country whose economy is based mainly on agriculture and livestock for export, has experienced a major expansion in mechanized crops during the last few decades. Despite being heavily dependent on agriculture, Paraguay has very limited research on crop weeds, in spite of these having a high economic impact on production. This work aims to update and enhance the knowledgebase on the most common weeds affecting productive fields throughout the different ecoregions of Paraguay. We present here the first checklist of crop weeds for the country, which includes a total of 256 taxa (189 species, 10 subspecies, 54 varieties and 3 forms), with the most species-rich families being Poaceae and Asteraceae followed by Malvaceae, Amaranthaceae, Fabaceae and Solanaceae. The list includes three new records for the country. Synonyms, distribution details within Paraguay, habit and a voucher specimen are provided for each taxon.
Journal Article
Thysanoptera of Bulgaria
The present checklist includes data on the species composition, geographic distribution and feeding preferences of thrips species in Bulgaria. In total, 155 species in 48 genera are listed. Of these, 125 species belong to suborder Terebrantia and include 103 species of 33 genera in family Thripidae, 14 species of two genera in Aeolothripidae, seven species of two genera in Melanthripidae and one species in Fauriellidae. In suborder Tubulifera, 30 species of 10 genera in the single family Phlaeothripidae are listed. Of the 155 Bulgarian thrips species, 87.7% are phytophagous, 4.5% are obligate predators, 5.8% are mycophagous and 1.9% are with unknown feeding preferences. Fourteen pest species are listed for Bulgaria, of which Frankliniella
occidentalis, Thrips
tabaci and Haplothrips
tritici are of economic importance. The list provides detailed information on the horizontal and vertical distribution of Thysanoptera in 5 regions and 45 subregions of Bulgaria. The present paper also includes an evaluation of the biodiversity of Thysanoptera and the extent to which each region of the country has been studied.
Journal Article
Updated list of Collembola species currently recorded from South Africa
Understanding the abundance and richness of species is one of the most fundamental steps in effecting their conservation. Despite global recognition of the significance of the below-ground component of diversity for ecosystem functioning, the soil remains a poorly studied terrestrial ecosystem. In South Africa, knowledge is increasing for a variety of soil faunal groups, but many still remain poorly understood. We have started to address this gap in the knowledge of South African soil biodiversity by focusing on the Collembola in an integrated project that encompasses systematics, barcoding and ecological assessments. Here we provide an updated list of the Collembola species from South Africa. A total of 124 species from 61 genera and 17 families has been recorded, of which 75 are considered endemic, 24 widespread, and 25 introduced. This total number of species excludes the 36 species we consider to be dubious. From the published data, Collembola species richness is high compared to other African countries, but low compared to European countries. This is largely a consequence of poor sampling in the African region, as our discovery of many new species in South Africa demonstrates. Our analyses also show that much ongoing work will be required before a reasonably comprehensive and spatially explicit picture of South Africa’s springtail fauna can be provided, which may well exceed 1000 species. Such work will be necessary to help South Africa meet its commitments to biodiversity conservation, especially in the context of the 2020 Aichi targets of the Convention on Biological Diversity.
Journal Article