965 resultados para Institutional Review Boards


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Sundarbans, a Ramsar and World Heritage site, is the largest single block of tidal halophytic mangrove forest in the world covering parts of Bangladesh and India. Natural mangroves were very common along the entire coast of Bangladesh. However, all other natural mangrove forests, including the Chakaria Sundarbans with 21,000 hectares of mangrove, have been cleared for shrimp cultivation. Against this backdrop, the Forest Department of Bangladesh has developed project design documents for a project called ‘Collaborative REDD+ Improved Forest Management (IFM) Sundarbans Project’ (CRISP) to save the only remaining natural mangrove forest of the country. This project, involving conservation of 412,000 ha of natural mangrove forests, is expected to generate, over a 30-year period, a total emissions reduction of about 6.4 million tons of CO2. However, the successful implementation of this project involves a number of critical legal and institutional issues. It may involve complex legal issues such as forest ownership, forest use rights, rights of local people and carbon rights. It may also involve institutional reforms. Ensuring good governance of the proposed project is very vital considering the failure of the Asian Development Bank (ADB) funded and Bangladesh Forest Department managed ‘Sundarbans Biodiversity Conservation Project’. Considering this previous experience, this paper suggests that a comprehensive legal and institutional review and reform is needed for the successful implementation of the proposed CRISP project. This paper argues that without ensuring local people’s rights and their participation, no project can be successful in the Sundarbans. Moreover, corruption of local and international officials may be a serious hurdle in the successful implementation of the project.

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When educational research is conducted online, we sometimes promise our participants that they will be anonymous—but do we deliver on this promise? We have been warned since 1996 to be careful when using direct quotes in Internet research, as full-text web search engines make it easy to find chunks of text online. This paper details an empirical study into the prevalence of direct quotes from participants in a subset of the educational technology literature. Using basic web search techniques, the source of direct quotes could be found in 10 of 112 articles. Analysis of the articles revealed previously undiscussed threats from data triangulation and expert analysis/diagnosis. Issues of ethical obliviousness, obscurity and concern for future privacy-invasive technologies are also discussed. Recommendations for researchers, journals and institutional ethics review boards are made for how to better protect participants' anonymity against current and future threats.

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Introduction. Patients with terminal heart failure have increased more than the available organs leading to a high mortality rate on the waiting list. Use of Marginal and expanded criteria donors has increased due to the heart shortage. Objective. We analyzed all heart transplantations (HTx) in Sao Paulo state over 8 years for donor profile and recipient risk factors. Method. This multi-institutional review collected HTx data from all institutions in the state of Sao Paulo, Brazil. From 2002 to 2008 (6 years), only 512 (28.8%) of 1777 available heart donors were accepted for transplantation. All medical records were analyzed retrospectively; none of the used donors was excluded, even those considered to be nonstandard. Results. The hospital mortality rate was 27.9% (n = 143) and the average follow-up time was 29.4 +/- 28.4 months. The survival rate was 55.5% (n = 285) at 6 years after HTx. Univariate analysis showed the following factors to impact survival: age (P = .0004), arterial hypertension (P = .4620), norepinephrine (P = .0450), cardiac arrest (P = .8500), diabetes mellitus (P = .5120), infection (P = .1470), CKMB (creatine kinase MB) (P = .8694), creatinine (P = .7225), and Na+ (P = .3273). On multivariate analysis, only age showed significance; logistic regression showed a significant cut-off at 40 years: organs from donors older than 40 years showed a lower late survival rates (P = .0032). Conclusions. Donor age older than 40 years represents an important risk factor for survival after HTx. Neither donor gender nor norepinephrine use negatively affected early survival.

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Objective: To investigate family members’ experiences of involvement in a previous study (conducted August 1995 to June 1997) following their child’s diagnosis with Ewing’s sarcoma. Design: Retrospective survey, conducted between 1 November and 30 November 1997, using a postal questionnaire. Participants: Eighty-one of 97 families who had previously completed an in-depth interview as part of a national case–control study of Ewing’s sarcoma. Main outcome measures: Participants’ views on how participation in the previous study had affected them and what motivated them to participate. Results: Most study participants indicated that taking part in the previous study had been a positive experience. Most (n = 79 [97.5%]) believed their involvement would benefit others and were glad to have participated, despite expecting and finding some parts of the interview to be painful. Parents whose child was still alive at the time of the interview recalled participation as more painful than those whose child had died before the interview. Parents who had completed the interview less than a year before our study recalled it as being more painful than those who had completed it more than a year before. Conclusions: That people suffering bereavement are generally eager to participate in research and may indeed find it a positive experience is useful information for members of ethics review boards and other “gatekeepers”, who frequently need to determine whether studies into sensitive areas should be approved. Such information may also help members of the community to make an informed decision regarding participation in such research.

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Sundarbans, a Ramsar and World Heritage site, is the largest single block of tidal halophytic mangrove forest in the world covering parts of Bangladesh and India. Natural mangroves were very common along the entire coast of Bangladesh. However, all other natural mangrove forests, including the Chakaria Sundarbans with 21,000 hectares of mangrove, have been cleared for shrimp cultivation. Against this backdrop, the Forest Department of Bangladesh has developed project design documents for a project called ‘Collaborative REDD+ Improved Forest Management (IFM) Sundarbans Project’ (CRISP) to save the only remaining natural mangrove forest of the country. This project, involving conservation of 412,000 ha of natural mangrove forests, is expected to generate, over a 30-year period, a total emissions reduction of about 6.4 million tons of CO2. However, the successful implementation of this project involves a number of critical legal and institutional issues. It may involve complex legal issues such as forest ownership, forest use rights, rights of local people and carbon rights. It may also involve institutional reforms. Ensuring good governance of the proposed project is very vital considering the failure of the Asian Development Bank (ADB) funded and Bangladesh Forest Department managed ‘Sundarbans Biodiversity Conservation Project’. Considering this previous experience, this paper suggests that a comprehensive legal and institutional review and reform is needed for the successful implementation of the proposed CRISP project. This paper argues that without ensuring local people’s rights and their participation, no project can be successful in the Sundarbans. Moreover, corruption of local and international officials may be a serious hurdle in the successful implementation of the project.

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Before tissue plasminogen activator (tPA) was licensed for use in Canada, in February 1999, the Calgary Regional Stroke Program spearheaded the development and organization of local resources to use thrombolytic therapy in patients who had experienced acute ischemic stroke. In 1996 special permission was obtained from the Calgary Regional Health Authority to use intravenously administered tPA for acute ischemic stroke, and ethical and scientific review boards approved the protocols. After 3 years our efforts have resulted in improved patient outcomes, shorter times from symptom onset to treatment and acceptable adverse event rates. Areas for continued improvement include the door-to-needle time and broader education of the public about the symptoms of acute ischemic stroke.

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BACKGROUND: Nonparametric Bayesian techniques have been developed recently to extend the sophistication of factor models, allowing one to infer the number of appropriate factors from the observed data. We consider such techniques for sparse factor analysis, with application to gene-expression data from three virus challenge studies. Particular attention is placed on employing the Beta Process (BP), the Indian Buffet Process (IBP), and related sparseness-promoting techniques to infer a proper number of factors. The posterior density function on the model parameters is computed using Gibbs sampling and variational Bayesian (VB) analysis. RESULTS: Time-evolving gene-expression data are considered for respiratory syncytial virus (RSV), Rhino virus, and influenza, using blood samples from healthy human subjects. These data were acquired in three challenge studies, each executed after receiving institutional review board (IRB) approval from Duke University. Comparisons are made between several alternative means of per-forming nonparametric factor analysis on these data, with comparisons as well to sparse-PCA and Penalized Matrix Decomposition (PMD), closely related non-Bayesian approaches. CONCLUSIONS: Applying the Beta Process to the factor scores, or to the singular values of a pseudo-SVD construction, the proposed algorithms infer the number of factors in gene-expression data. For real data the "true" number of factors is unknown; in our simulations we consider a range of noise variances, and the proposed Bayesian models inferred the number of factors accurately relative to other methods in the literature, such as sparse-PCA and PMD. We have also identified a "pan-viral" factor of importance for each of the three viruses considered in this study. We have identified a set of genes associated with this pan-viral factor, of interest for early detection of such viruses based upon the host response, as quantified via gene-expression data.

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En salle d’opération, les tâches de l’anesthésiste sont nombreuses. Alors que l’utilisation de nouveaux outils technologiques l’informe plus fidèlement sur ce qui se passe pour son patient, ces outils font que ses tâches deviennent plus exigeantes. En vue de diminuer cette charge de travail, nous avons considérer l’administration automatique d’agents anesthésiques en se servant de contrôle en boucle fermée. À cette fin, nous avons développé un système d’administration d’un agent anesthésique (le propofol) visant à maintenir à un niveau optimal la perte de conscience du patient pendant toute la durée d’une chirurgie. Le système comprend un ordinateur, un moniteur d’anesthésie et une pompe de perfusion. L’ordinateur est doté d’un algorithme de contrôle qui, à partir d’un indice (Bispectral IndexTM ou BIS) fournit par le moniteur d’anesthésie détermine le taux d’infusion de l’agent anesthésiant. Au départ, l’anesthésiste choisit une valeur cible pour la variable de contrôle BIS et l’algorithme, basé sur système expert, calcule les doses de perfusion de propofol de sorte que la valeur mesurée de BIS se rapproche le plus possible de la valeur cible établie. Comme interface-utilisateur pour un nouveau moniteur d’anesthésie, quatre sortes d’affichage ont été considérés: purement numérique, purement graphique, un mélange entre graphique et numérique et un affichage graphique intégré (soit bidimensionnel). À partir de 20 scenarios différents où des paramètres normaux et anormaux en anesthésie étaient présentés à des anesthésistes et des résidents, l’étude des temps de réaction, de l’exactitude des réponses et de la convivialité (évaluée par le NASA-TLX) a montré qu’un affichage qui combine des éléments graphiques et numériques était le meilleur choix comme interface du système. Une étude clinique a été réalisée pour comparer le comportement du système d’administration de propofol en boucle fermée comparativement à une anesthésie contrôlée de façon manuelle et conventionnelle où le BIS était aussi utilisé. Suite à l’approbation du comité d’éthique et le consentement de personnes ayant à subir des chirurgies générales et orthopédiques, 40 patients ont été distribués également et aléatoirement soit dans le Groupe contrôle, soit dans le Groupe boucle fermée. Après l’induction manuelle de propofol (1.5 mg/kg), le contrôle en boucle fermée a été déclenché pour maintenir l’anesthésie à une cible de BIS fixée à 45. Dans l’autre groupe, le propofol a été administré à l’aide d’une pompe de perfusion et l’anesthésiste avait aussi à garder manuellement l’indice BIS le plus proche possible de 45. En fonction du BIS mesuré, la performance du contrôle exercé a été définie comme excellente pendant les moments où la valeur du BIS mesurée se situait à ±10% de la valeur cible, bonne si comprise de ±10% à ±20%, faible si comprise de ±20% à ±30% ou inadéquate lorsque >±30%. Dans le Groupe boucle fermée, le système a montré un contrôle excellent durant 55% du temps total de l’intervention, un bon contrôle durant 29% du temps et faible que pendant 9% du temps. Le temps depuis l’arrêt de la perfusion jusqu’à l’extubation est de 9 ± 3.7 min. Dans le Groupe contrôle, un contrôle excellent, bon, et faible a été enregistré durant 33%, 33% et 15% du temps respectivement et les doses ont été changées manuellement par l’anesthésiste en moyenne 9.5±4 fois par h. L’extubation a été accomplie après 11.9 ± 3.3 min de l’arrêt de la perfusion. Dans le Groupe boucle fermée, un contrôle excellent a été obtenu plus longtemps au cours des interventions (P<0.0001) et un contrôle inadéquat moins longtemps (P=0.001) que dans le Groupe contrôle. Le système en boucle fermée d’administration de propofol permet donc de maintenir plus facilement l’anesthésie au voisinage d’une cible choisie que l’administration manuelle.

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Au Canada, les Commissions d'Examen des Troubles Mentaux de chaque province ont la responsabilité de déterminer les conditions de prise en charge des personnes déclarées Non Criminellement Responsables pour cause de Troubles Mentaux (NCRTM) et de rendre, sur une base annuelle une des trois décisions suivantes: a) détention dans un hôpital, b) libération conditionnelle, ou c) libération absolue. Pour favoriser la réinsertion sociale, la libération conditionnelle peut être ordonnée avec la condition de vivre dans une ressource d’hébergement dans la communauté. Parmi les personnes vivant avec une maladie mentale, l’accès aux ressources d’hébergement a été associé à une plus grande stabilité résidentielle, une réduction de nombre et de la durée de séjours d'hospitalisation ainsi qu’une réduction des contacts avec le système judiciaire. Toutefois, l’accès aux ressources d’hébergement pour les personnes trouvées NCRTM est limité, en partie lié à la stigmatisation qui entoure cette population. Il existe peu d’études qui traitent du placement en ressources d’hébergement en psychiatrie légale. Pour répondre à cette question, cette thèse comporte trois volets qui seront présentés dans le cadre de deux manuscrits: 1) évaluer le rôle du placement en ressources d’hébergement sur la réhospitalisation et la récidive chez les personnes trouvées NCRTM; 2) décrire les trajectoires de disposition et de placement en ressources d’hébergement, et 3) mieux comprendre les facteurs associés à ces trajectoires. Les données de la province du Québec du Projet National de Trajectoires d’individus trouvés NCRTM ont été utilisées. Un total de 934 personnes trouvées NCRTM entre le 1er mai 2000 et le 30 avril 2005 compose cet échantillon. Dans le premier manuscrit, l’analyse de survie démontre que les individus placés dans un logement indépendant suite à une libération conditionnelle de la Commission d’Examen sont plus susceptibles de commettre une nouvelle infraction et d’être ré-hospitalisés que les personnes en ressources d’hébergement. Dans le deuxième article, l'analyse de données séquentielle a généré quatre modèles statistiquement stables de trajectoires de disposition et de placement résidentiel pour les 36 mois suivant un verdict de NCRTM: 1) libération conditionnelle dans une ressource d’hébergement (11%), 2) libération conditionnelle dans un logement autonome (32%), 3) détention (43%), et 4) libération absolue (14%). Une régression logistique multinomiale révèle que la probabilité d'un placement en ressource supervisée comparé au maintien en détention est significativement réduite pour les personnes traitées dans un hôpital spécialisé en psychiatrie légale, ainsi que pour ceux ayant commis un délit sévère. D'autre part, la probabilité d’être soumis à des dispositions moins restrictives (soit le logement indépendant et la libération absolue) est fortement associée à des facteurs cliniques tels qu’un nombre réduit d'hospitalisations psychiatriques antérieures, un diagnostic de trouble de l'humeur et une absence de diagnostic de trouble de la personnalité. Les résultats de ce projet doctoral soulignent la valeur protectrice des ressources en hébergement pour les personnes trouvées NCRTM, en plus d’apporter des arguments solides pour une gestion de risque chez les personnes trouvées NCRTM qui incorpore des éléments contextuels de prévention du risque, tel que l’accès à des ressources d’hébergement.

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Les artéfacts métalliques entraînent un épaississement artéfactuel de la paroi des tuteurs en tomodensitométrie (TDM) avec réduction apparente de leur lumière. Cette étude transversale prospective, devis mesures répétées et observateurs avec méthode en aveugle, chez 24 patients consécutifs/71 tuteurs coronariens a pour objectif de comparer l’épaisseur de paroi des tuteurs en TDM après reconstruction par un algorithme avec renforcement des bords et un algorithme standard. Une angiographie coronarienne par TDM 256 coupes a été réalisée, avec reconstruction par algorithmes avec renforcement des bords et standard. L’épaisseur de paroi des tuteurs était mesurée par méthodes orthogonale (diamètres) et circonférentielle (circonférences). La qualité d’image des tuteurs était évaluée par échelle ordinale, et les données analysées par modèles linéaire mixte et régression logistique des cotes proportionnelles. L’épaisseur de paroi des tuteurs était inférieure avec l’algorithme avec renforcement des bords comparé à l’algorithme standard, avec les méthodes orthogonale (0,97±0,02 vs 1,09±0,03 mm, respectivement; p<0,001) et circonférentielle (1,13±0,02 vs 1,21±0,02 mm, respectivement; p<0,001). Le premier causait moins de surestimation par rapport à l’épaisseur nominale comparé au second, avec méthodes orthogonale (0,89±0,19 vs 1,00±0,26 mm, respectivement; p<0,001) et circonférentielle (1,06±0,26 vs 1,13±0,31 mm, respectivement; p=0,005) et diminuait de 6 % la surestimation. Les scores de qualité étaient meilleurs avec l’algorithme avec renforcement des bords (OR 3,71; IC 95% 2,33–5,92; p<0,001). En conclusion, la reconstruction des images avec l’algorithme avec renforcement des bords génère des parois de tuteurs plus minces, moins de surestimation, et de meilleurs scores de qualité d’image que l’algorithme standard.

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PURPOSE: To investigate prospectively the relative accuracy of computed tomographic (CT) angiography, calcium scoring (CS), and both methods combined in demonstrating coronary artery stenoses by using conventional angiography as the reference standard. MATERIALS AND METHODS: The study was approved by the institutional review board Human Research Ethics Committee, and all patients completed written informed consent. Fifty patients (40 men, 10 women) aged 62 years ± 11 (± standard deviation) who were suspected of having coronary artery disease underwent both conventional coronary angiography and multisection coronary CT angiography with CS. Sensitivity and specificity of CS, CT angiography, and both methods combined in demonstrating luminal stenosis greater than or equal to 50% were determined for each arterial segment, coronary vessel, and patient. Receiver operating characteristic (ROC) curves were generated for CS prediction of significant stenosis, and the Mann-Whitney U test was used for comparison of CS between groups. RESULTS: When used with segment-specific electrocardiographic phase reconstructions, CT angiography demonstrated stenosed segments with 79% sensitivity and 95% specificity. Mean calcium score was greater in segments, vessels, and patients with stenoses than in segments, vessels, and patients without stenoses (P < .001 for all); nine (16%) of 56 stenosed segments, however, had a calcium score of 0. The patient calcium score correlated strongly with the number of stenosed arteries (Spearman {rho} = 0.75, P < .001). CS was more accurate in demonstrating stenosis in patients than in segments (areas under ROC curve were 0.88 and 0.74, respectively). CT angiography, however, was more accurate than CS in demonstrating stenosis in patients, vessels, and segments. The sensitivity and specificity of CS varied according to the threshold used, but when the calcium score cutoff (ie, >150) matched the specificity of CT angiography (95%), the sensitivity of CS in demonstrating stenosed segments was 29% (compared with 79% for CT angiography). Combining CT angiography with CS (at threshold of 400) improved the sensitivity of CT angiography (from 93% to 100%) in demonstrating significant coronary disease in patients, without a loss of specificity (85%); this finding, however, was not statistically significant. CONCLUSION: CT angiography is more accurate than CS in demonstrating coronary stenoses. A patient calcium score of greater than or equal to 400, however, can be used to potentially identify patients with significant coronary stenoses not detected at CT angiography.

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This article reflects on a university human research ethics committee’s unease regarding a feminist visual pilot study within the field of education. The small exploratory study proposed to explore a migrant mother’s production of her son’s identity through her family photograph collection. The committee requested substantial changes to the research design which centred primarily on their concerns regarding risk of harm to pre-existing relationships, and also issues of anonymity and consent. I consider the combined liberal individualist, utilitarian and positivist biomedical basis for the ethics committee’s discomfort with the proposed research which was to involve members of my family. I draw on my experience of the review process to critique the human research ethics committee paradigm which constructs the ideal researcher as an objective and disinterested observer, hinges on a weighing of risks and benefits, and considers humans to be independent and equal. I demonstrate how the blanket application of these values acts to problematise some kinds of research, and how these values can be inappropriate, incompatible and even destructive when applied to research proposals that are exploratory, visual, and/or involve the researcher’s family members as participants.

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O objetivo deste estudo foi avaliar a eficácia, a segurança e a farmacocinética da talidomida nos pacientes com câncer colorretal metastático. Dezessete pacientes com adenocarcinoma colorretal metastático, previamente tratados com pelo menos um regime de quimioterapia, foram incluídos no estudo. Os pacientes eram inicialmente tratados com talidomida 200 mg/dia, com um aumento de dose de 200mg a cada duas semanas, até atingir a dose máxima de 800 mg/dia. Os pacientes eram reavaliados a cada duas semanas para toxicidade e a cada 8 semanas para taxa de resposta através de exames de imagem. A farmacocinética foi caracterizada em quatro pacientes no nível de dose de 200 mg/dia.Todos os dezessete pacientes incluídos foram avaliados no perfil de toxicidade e quatorze pacientes nos critérios de taxa de resposta. A talidomida foi bem tolerada, sendo os principais efeitos colaterais a sonolência, a tontura, a xerostomia e a constipação. Não houve nenhuma resposta objetiva ou doença estável após oito semanas de tratamento. A sobrevida global mediana foi de 3,6 meses. A talidomida é bem tolerada como agente único de tratamento, mas não demonstrou nenhuma atividade antitumoral em pacientes com câncer colorretal metastático, já tratados previamente com outro regime de quimioterapia. Apesar disto, futuros estudos com este agente em estágios iniciais desta neoplasia devem ser considerados, quando as propriedades antiangiogênicas desta droga poderão ser mais relevantes para a progressão da doença.

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Purpose: To test the null hypothesis that beveling and/or etching enamel would not affect the 18-month clinical performance of the self-etching adhesive Clearfil SE Bond (CSEB) in noncarious cervical lesions (NCCL). Methods: With Institutional Review Board approval, 34 patients were enrolled in this study. A total of 120 NCCL was selected and assigned to four groups: (1) CSEB was applied without any cavity preparation; (2) CSEB was applied after beveling enamel; (3) CSEB was applied after etching enamel for 15 seconds with 35% phosphoric acid; (4) CSEB was applied after beveling and etching enamel. A microfilled composite resin was used for all restorations. Resuts: At 6 months after initial placement, 120 restorations (a 100% recall rate) were evaluated. At 18 months, 87 restorations (a 72.5% recall rate) were available for evaluation. A survival rate of 100% was measured for all groups at both 6 and 18 months. Sensitivity to air decreased significantly only for Group 3 (no bevel+acid etch) from baseline to 18 months without statistical changes from 6 months to 18 months. None of the other parameters resulted in significant differences for any of the four groups. However, when data were pooled, both the overall marginal discoloration and the overall marginal adaptation were significantly worse at 18 months than at baseline, while sensitivity to air decreased significantly from baseline to 18 months. The 18-month survival rate of the self-etching adhesive Clearfil SE Bond was not improved by enamel bevel or by enamel etching. Both overall marginal adaptation and overall marginal discoloration were worse at 18 months than at baseline.

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Purpose: To evaluate the 1-year clinical performance of three self-etching adhesives (Adper Prompt L-Pop, Clearfil S-3 Bond, iBond) in posterior composite restorations using one etch&rinse adhesive (One-Step Plus) as control. Methods: Upon approval by the Institutional Review Board, 121 restorations were inserted in 38 subjects. The adhesives were applied as per manufacturers' instructions. Preparations were restored with a nanofilled resin composite (Filtek Supreme) and evaluated at baseline, 6 months, and 1 year. Statistical analyses included the Chi-square distribution with the McNemar non-parametric test (P< 0.05). Results: At 1 year, 111 restorations in 35 subjects were evaluated using the USPHS modified criteria. No significant changes were observed for the etch&rinse adhesive One-Step Plus. At 1 year the number of Alfa ratings decreased significantly for Clearfil S-3 Bond and for iBond in the categories color match, marginal staining, and marginal adaptation. For Adper Prompt L-Pop, marginal adaptation at 1 year was significantly worse than at baseline. Postoperative sensitivity to air improved significantly for Adper Prompt L-Pop, Clearfil S-3 Bond, and iBond. When the evaluation criteria were paired at 1 year, iBond resulted in a significantly lower number of Alfa ratings than any of the other adhesives for color match, marginal staining, and marginal adaptation. One-Step Plus resulted in a greater number of Alfa ratings for marginal adaptation than either Adper Prompt L-Pop or Clearfil S-3 Bond. Marginal adaptation was significantly better for Clearfil S-3 Bond than for Adper Prompt L-Pop. The post-operative sensitivity measured at 1 year for Adper Prompt L-Pop was statistically better than that for One-Step Plus.