Core outcome domains for chronic pain clinical trials: IMMPACT recommendations

Objective. To provide recommendations for the core outcome domains that should be considered by investigators conducting clinical trials of the efficacy and effectiveness of treatments for chronic pain. Development of a core set of outcome domains would facilitate comparison and pooling of data, encourage more complete reporting of outcomes, simplify the preparation and review of research proposals and manuscripts, and allow clinicians to make informed decisions regarding the risks and benefits of treatment. Methods. Under the auspices of the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT), 27 specialists from academia. governmental agencies, and the pharmaceutical industry participated in a consensus meeting and identified core outcome domains that should be considered in clinical trials of treatments for chronic pain. Conclusions. There was a consensus that chronic pain clinical trials should assess outcomes representing six core domains: (1) pain, (2) physical functioning, (3) emotional functioning, (4) participant ratings of improvement and satisfaction with treatment, (5) symptoms and adverse events, (6) participant disposition (e.g. adherence to the treatment regimen and reasons for premature withdrawal from the trial). Although consideration should be given to the assessment of each of these domains, there may be exceptions to the general recommendation to include all of these domains in chronic pain trials. When this occurs, the rationale for not including domains should be provided. It is not the intention of these recommendations that assessment of the core domains should be considered a requirement for approval of product applications by regulatory agencies or that a treatment must demonstrate statistically significant effects for all of the relevant core domains to establish evidence of its efficacy. (C) 2003 International Association for the Study of Pain.

Outcome variables for osteoarthritis clinical trials: the OMERACT-OARSI set of responder criteria

Improvement in analysis and reporting results of osteoarthritis (OA) clinical trials has been recently obtained because of harmonization and standardization of the selection of outcome variables (OMERACT 3 and OARSI). Moreover, OARSI has recently proposed the OARSI responder criteria. This composite index permits presentation of results of symptom modifying clinical trials in OA based on individual patient responses (responder yes/no). The 2 organizations (OMERACT and OARSI) established. a task force aimed at evaluating: (1) the variability of observed placebo and active treatment effects using the OARSI responder criteria; and (2) the possibility of proposing a simplified set of criteria. The conclusions of the task force were presented and discussed during the OMERACT 6 conference, where a simplified set of responder criteria (OMERACT-OARSI set of criteria) was proposed.

Mosquito host-feeding patterns and implications for Japanese encephalitis virus transmission in northern Australia and Papua New Guinea

Japanese encephalitis (JE) virus spread to northern Australia during the 1990s, transmitted by Culex annulirostris Skuse and other mosquitoes (Diptera: Culicidae). To determine the relative importance of various hosts for potential vectors of JE virus, we investigated the host-feeding patterns of mosquitoes in northern Australia and Western Province of Papua New Guinea, with particular attention to pigs, Sus scrofa L. - the main amplifying host of JE virus in South-east Asia. Mosquitoes were collected by CDC light traps baited with dry ice and 1-octen-3-ol, run 16.00-08.00 hours, mostly set away from human habitations, if possible in places frequented by feral pigs. Bloodmeals of 2569 mosquitoes, representing 15 species, were identified by gel diffusion assay. All species had fed mostly on mammals: only 30%) were trapped where domestic pigs were kept close to human habitation. From seven of eight locations on the Australian mainland, the majority of Cx. annulirostris had obtained their bloodmeals from marsupials, probably the Agile wallaby Macropus agilis (Gould). Overall proportions of mosquito bloodmeals identified as marsupial were 60% from the Gulf Plains region of Australia, 78% from the Cape York Peninsula and 64% from the Daru area of Papua New Guinea. Thus, despite the abundance of feral pigs in northern Australia, our findings suggest that marsupials divert host-seeking Cx. annulirostris away from pigs. As marsupials are poor JE virus hosts, the prevalence of marsupials may impede the establishment of JE virus in Australia.

Feeding non-preference by Spodoptera frugiperda and Spodoptera eridania on tomato genotypes

Larvae of the genus Spodoptera spp. are highly polyphagous and can cause economical losses in several agricultural crops. Given their growing importance in the tomato crop, especially for industry, this work aimed to evaluate the feeding non-preference by larvae of Spodoptera frugiperda (J. E. Smith, 1797) and Spodoptera eridania (Cramer, 1782) on tomato genotypes and classify them by the levels of resistance. The commercial cultivar Santa Clara was set as the susceptible standard and line PI 134417 as the resistant standard to evaluate the lines PI 134418, PI 126931, LA 462 and LA 716. Feeding non-preference tests were performed under non-choice and free-choice conditions to evaluate the genotype attractiveness to larvae at predetermined times after their release, as well as the leaf area consumed. Overall, the genotypes LA 716 and PI 126931 were the least attractive to S. frugiperda, whereas Santa Clara was the most attractive and consumed. For S. eridania, the genotypes PI 126931, LA 462, LA 716 and PI 134418 were the least preferred for feeding, and Santa Clara and PI 134417 were the most attractive and consumed. The genotypes LA 716 and PI 126931 are moderately resistant to S. frugiperda and S. eridania; PI 134418 and LA 462 are moderately resistant to S. eridania; PI 134417 is susceptible to S. frugiperda and S. eridania; and Santa Clara is highly susceptible to both S. frugiperda and S. eridania.

Supplementary feeding programs: a critical analysis

A critical analysis of the Supplementary Feeding Programs which have been undertaken around the world is presented. Although only a few programs have been rigorously evaluated it seems that in relation to their main objectives, most of them have not proved to be successful. Some suggestions for improvement are put forward and the particular case of the Brazilian programs is assessed in detail.

Factors associated with infant feeding practices after hospital discharge

OBJECTIVE: To assess factors associated with infant feeding practices on the first day at home after hospital discharge. METHODS: A total of 209 women, who had a child aged four months or less and were living in Itapira, Brazil, were interviewed during the National Immunization Campaign Day in 1999. Statistical analysis was performed using the Chi-square test and a logistic regression model was used for verifying an association between dependent and independent variables. RESULTS: Women aged 25.5 years on average and 18.2% were teenagers. Fifty-three percent of the women delivered vaginally and most vaginal deliveries (78.5%) took place in the public hospital. The prevalence of exclusive breastfeeding on the first day at home was 78.1% and 11.6% of the infants were receiving formula at this time. The only factor associated with EBF on the first day at home was being a teenaged-primiparous mother (OR=9.40; 95% CI: 1.24-71.27). This association remained statistically significant even after controlling for type of delivery and hospital where the birth took place. Feeding formula on the first day at home was only significantly associated with the hospital (i.e., birth at the city hospital was a protective factor (OR=0.33; 95% CI: 0.13-0.86), even after controlling for vaginal delivery. CONCLUSIONS: On the first day at home after hospital discharge, teenaged-primiparous mothers were more likely to exclusive breastfeeding as well as those infants born in the municipal public hospital. Further studies are needed from a multidisciplinary approach.

Notes on the feeding habits of Gaidropsarus guttatus (Collett, 1890) from Faial Island, Azores, NE Atlantic, PT

Copyright © 2014 Société Française d’Ichtyologie.

Feeding strategy and trophic ontogeny in Scorpaena maderensis (Scorpaeniformes: Scorpaenidae) from the Azores, NE Atlantic

Copyright © 2014 Société Française d'Ichtyologie.

Opportunistic feeding behavior of Diplodus argenteus (Perciformes, Sparidae) : human-fish interaction in two rocky reefs from SE and S Brazil

Comportamento alimentar oportunista do marimbá Diplodus argenteus (Perciformes, Sparidae): interação humana-peixe em dois sistemas de costões rochosos do SE e SU do Brasil. Esse artigo aborda dois tipos de comportamentos alimentares do marimbá Diplodus argenteus em dois sistemas de costões rochosos do Atlântico sul no Brasil. Essa espécie alimentou-se sobre o fundo e exibiu comportamentos ocasionais e oportunísticos.

Postdischarge feeding of growing “Preemies”: concerns with limiting fat intake [letter]

The didactic update on requirements, types of feeding and dosages of nutrients by Su is a useful guide for clinicians on optimization of nutrition in preterm infants. We take this opportunity to focus on postdischarge nutrition in very preterm infants, which has not yet reached consensus, because of concerns regarding the potentially negative consequences of rapid catch-up growth on obesity and metabolic programming. Some formula feeding approaches have been proposed when mother’s milk is not available.

Determinants of using pacifier and bottle feeding

OBJECTIVE To analyze the factors associated with the use of pacifiers and/or bottle feeding in infants aged under one year.METHODS This is a cross-sectional study with 34,366 children and using data from the database of the 2nd Nationwide Survey of Breastfeeding Prevalence performed in the Brazilian capitals and Federal District in 2008. Cluster sampling was used. The questionnaire included questions about the use of artificial nipples in the last 24 hours. The analysis considered three outcomes: exclusive use of pacifier, exclusive use of bottle feeding, and use of artificial nipples (pacifier and bottle feeding). Prevalence ratios were obtained using Poisson regression with robust variance following a hierarchical model.RESULTS The following factors were associated with exclusive use of the pacifier: mother working outside the home, primiparity, child was not breastfed within the first hour, and child had consumed tea on the first day at home. The following factors were associated with exclusive use of bottle feeding: mother working outside the home, primiparity, low birth weight, child not breastfed within the first hour, and child had consumed milk formula and tea on the first day at home. The following factors were associated with use of artificial nipples (pacifier and bottle feeding): mother working outside the home, primiparity, cesarean delivery, the male gender, low birth weight, born in a hospital not accredited as “baby friendly”, required health baby monitoring in the Primary Health Care Unit (PR = 0.91), and child had consumed milk formula, water, or tea on the first day at home.CONCLUSIONS This study identified profiles of exclusive users of pacifiers, bottle feeding, and both. The provided information can guide preventive practices for child health.

Serum trace elements in dysphagic gastrostomy candidates before endoscopic gastrostomy for long term enteral feeding

Background & aims - Patients who underwent endoscopic gastrostomy (PEG) present protein-energy malnutrition, but little is known about Trace Elements (TE), Zinc (Zn), Copper (Cu), Selenium (Se), Iron (Fe), Chromium (Cr). Our aim was the evaluation of serum TE in patients who underwent PEG and its relationship with serum proteins, BMI and nature of underlying disorder. Methods - A prospective observational study was performed collecting: patient's age, gender, underlying disorder, NRS-2002, BMI, serum albumin, transferrin and TE concentration. We used ferrozine colorimetric method for Fe; Inductively Coupled Plasma-Atomic Emission Spectroscopy for Zn/Cu; Furnace Atomic Absorption Spectroscopy for Se/Cr. The patients were divided into head and neck cancer (HNC) and neurological dysphagia (ND). Results - 146 patients (89 males), 21–95 years: HNC-56; ND-90. Low BMI in 78. Low values mostly for Zn (n = 122) and Fe (n = 69), but less for Se (n = 31), Cu (n = 16), Cr (n = 7); low albumin in 77, low transferrin in 94 and 66 with both proteins low. Significant differences between the groups of underlying disease only for Zn (t140.326 = −2,642, p < 0.01) and a correlation between proteins and TE respectively albumin and Zn (r = 0.197, p = 0.025), and albumin and Fe (r = 0.415, p = 0.000). Conclusions - When gastrostomy was performed, patients display low serum TE namely Zn, but also Fe, less striking regarding others TE. It was related with prolonged fasting, whatever the underlying disease. Low proteins were associated with low TE. Teams taking care of PEG-patients should use Zn supplementation and include other TE evaluation as part of the nutritional assessment of PEG candidates.

Lethality of triatomines (Hemiptera: Reduviiae), vectors of Chagas' disease, feeding on blood baits containing synthetic insecticides, under laboratory conditions

A laboratory study was conducted to test the toxicity of synthetic insecticides added to defibrinated sheep blood kept at room temperature and offered as food to the following triatomine species: Triatoma infestans, Panstrongylus megistus, Triatoma vitticeps, Triatoma pseudomaculata, Triatoma brasiliensis and Rhodnius prolixus. The insecticides used, at a concentration of 1g/l, were: HCH, DDT, Malathion and Trichlorfon, and the lethalithy observed at the end of a 7-day period varied according to the active principle of each. HCH was the most effective by the oral route, killing 100% of the insects, except P. megistus (95.7%) and T. pseudomaculata (94.1%). Trichlorfon killed the insects at rates ranging from 71.8% (T. vitticeps) to 98% (R. prolixus). Malathion was slightly less efficient, killing the insects at rates from 56.8% (T. vitticeps) to 97% (T.brasiliensis). DDT was the least effective, with a killing rate of 10% (T. vitticeps) to 75% (T.brasiliensis). Since the tests were performed at room temperature, we suggest that baits of this type should be tried for the control of triatomines in the field.