Submitted by Angela Maria de Oliveira (amolivei@uepg.br) on 2017-09-06T16:18:49Z No. of bitstreams: 2 license_rdf: 811 bytes, checksum: e39d27027a6cc9cb039ad269a5db8e34 (MD5) ANNA_LUIZA_SZESZ.pdf: 1800626 bytes, checksum: 05a915ed2eba46109040f4ee4162b620 (MD5) / Made available in DSpace on 2017-09-06T16:18:49Z (GMT). No. of bitstreams: 2 license_rdf: 811 bytes, checksum: e39d27027a6cc9cb039ad269a5db8e34 (MD5) ANNA_LUIZA_SZESZ.pdf: 1800626 bytes, checksum: 05a915ed2eba46109040f4ee4162b620 (MD5) Previous issue date: 2017-08-14 / O objetivo desse estudo foi identificar por meio de revisão sistemática e meta-análise se o condicionamento seletivo do esmalte antes da aplicação de sistemas adesivos autocondicionantes, melhora as taxas de retenção, descoloração e adaptação marginal de restaurações cervicais não-cariosas (LCNC) em pacientes adultos. As seguintes bases de dados foram pesquisadas MEDLINE, Scopus, Web of Science, LILACS, BBO Biblioteca, Biblioteca Cochrane e SIGLE, sem restrições, bem como os resumos da conferência anual da IADR, além do registro de ensaios clínicos. Dissertações e teses também foram pesquisados utilizando os bancos de dados da ProQuest e Periódicos Capes. Foram incluídos ensaios clínicos randomizados que compararam a eficácia clínica dos adesivos autocondicionantes com e sem condicionamento seletivo do esmalte usado para restaurações diretas de resina composta em LCNC na dentição permanente. Para avaliação da qualidade dos estudos foi utilizado a ferramenta risco de viés da colaboração Cochrane. Após a remoção das duplicatas, foram identificados 2689 artigos. Após triagem foram mantidos 10 estudos na síntese qualitativa. Sete foram considerados de baixo risco de viés. O tempo de avaliação dos estudos variaram entre 1 a 5 anos. Com exceção de um ano de acompanhamento, houve descoloração e desadaptação marginal significativamente menor durante todo o tempo de acompanhamento. Além disso, foi observada perda significativamente menor da retenção para as restaurações com 3 anos de acompanhamento para o grupo que utilizou o condicionamento seletivo do esmalte. O condicionamento seletivo do esmalte, antes da aplicação de sistemas adesivos autocondicionantes em LCNC, pode melhorar o desempenho clínico de restaurações em resina composta, em até 5 anos de acompanhamento. / The objective of this study was to identify through a systematic review and metaanalysis if selective etching of enamel margins, prior to the application of self-etching adhesive systems, improves the retention rates marginal discoloration and marginal adaptation of cervical composite restorations in non-carious cervical lesions (NCCLs) of adult patients. The following databases were searched for MEDLINE, Scopus, Web of Science, LILACS, BBO Library, Cochrane Library and SIGLE were searched without restrictions, as well as IADR abstracts and gray literature via trial registries. Dissertations and theses were searched using the ProQuest Dissertations and Periodical Capes. Randomized clinical trials comparing the clinical efficacy of selfetching adhesives with and without selective enamel etching used for direct composite resin restorations on NCCLs in the permanent dentition were included. For evaluate the quality of the studies, the bias risk tool Cochrane Collaboration, was used. After removal of duplicates, 2689 articles were identified. Following screening of abstracts, 10 studies remained in the qualitative synthesis. Seven were considered to be at “low” risk of bias. The report of the studies varied from 1 to 5 years. Except for one-year follow-up, there was a significantly lower marginal discoloration and adaptation during all follow-up periods. In addition, a significantly lower loss of retention was observed for the 3-year follow-up restorations for the group that used selective enamel conditioning. Selective enamel prior to application of self-etch adhesive systems in NCCLs might improve clinical performance of resin-composite cervical restorations, in up to 5 years of follow-up.

La qualité méthodologique en recherche clinique est une exigence garantissant la fiabilité des expérimentations médicales, au bénéfice des praticiens comme à celui des patients. Cette thèse a pour objectif de mesurer la qualité des essais thérapeutiques présentés au Comité d’Ethique de la Région Sud-Est II et son évolution sur des périodes pluriannuelles. Deux études transversales exhaustives ont été réalisées. La première a pour objet de mesurer l’impact du Règlement Pédiatrique Européen de 2007 sur l’évolution qualitative et quantitative de essais pédiatriques, compte tenu du faible nombre de recherches dans cette population. La deuxième analyse le niveau de qualité des essais contrôlés randomisés en utilisant le score de Jadad et identifie les éléments qui l’influencent. L'outil de travail est constitué des protocoles détenus par le Comité d’Ethique, et non de publications de la littérature. Le concept de qualité et ses deux composantes, éthique et fiabilité scientifique, a été étudié. Les différents outils proposés par les experts pour mesurer la qualité ont été expertisés, ce qui a permis la sélection de l’échelle méthodologiquement la plus adaptée. Le niveau de qualité observé pour les essais pédiatriques est élevé, mais n’a pas été influencé par le Règlement Européen, qui a pu, cependant, entraîner une progression forte du nombre des essais pédiatriques, pouvant être l’indice d’un développement de la recherche en pédiatrie. Concernant les essais contrôlés randomisés, deux marqueurs sont associés à un haut score qualité des protocoles, identifiés après une analyse multivariée : le caractère multicentrique de la recherche et les essais portant sur les médicaments. / Methodological quality in clinical research is mandatory to ensure the reliability of medical experiments, with benefits for both practitioners and patients. This PhD thesis aims at measuring the quality of therapeutic trials submitted to the Ethics Committee of the South-East Region II, and its evolution over several years. Two comprehensive cross-sectional studies were conducted. The first explore the field of pediatric research, and aims at measuring the impact of the introduction of European Pediatric Regulation in 2007, on the evolution of the quantity and quality of trials in this field, given the low number of research in this population. The second analyzes the quality of randomized controlled trials using the JADAD score and seeks to identify the elements that influence it. These studies were conducted using the protocols submitted to the Ethics Committee, and not from a literature analysis. The concept of quality was first studied based on their ethical and scientific reliability. The various assessing tools proposed by the experts to measure the quality were appraised, which allowed the selection of the most methodologically scale adapted to this study. Conclusion: we show that the level of quality observed for pediatric trials is high, but was not influenced by the introduction of the European Regulation, which could, on the other hand, have led to an important increase in the number of pediatric trials. Regarding randomized controlled trials, a multivariate analysis allowed the identification of two statistically significant markers associated with high quality score of the protocol: the multicentric character of the research, and the drugs trials.

O objetivo deste estudo é o de comparar os resultados clínicos e radiográficos do tratamento cirúrgico das fraturas da diáfise do úmero com haste intramedular bloqueada ou placa em ponte. Quarenta fraturas da diáfise do úmero, em 39 pacientes, dos tipos A, B ou C da classificação do grupo A.O., foram tratadas no período compreendido entre junho de 2003 e dezembro de 2007. Destas, após seleção por sorteio, 21 fraturas foram submetidas à osteossíntese com placas em ponte de 4,5 mm e parafusos (grupo PP) e 19 com hastes intramedulares bloqueadas não fresadas (grupo HIB). Duas eram fraturas expostas, uma do tipo II e outra do tipo III-a de Gustilo. Vinte e cinco pacientes eram do sexo masculino (64%) e a idade variou de 19 a 75 anos (idade média de 41 anos e 10 meses). O lado direito foi acometido em 22 pacientes (55%) e a queda, o mecanismo de trauma mais freqüente (46%). O tempo mínimo de seguimento foi de seis meses e o máximo de 60 meses para o grupo PP (M=34,5 meses) e de oito e 58 meses (M=27meses) para o grupo HIB. Em apenas um caso, operado com haste intramedular bloqueada, não houve a consolidação. Houve um caso de infecção profunda no grupo PP e um de infecção superficial no grupo HIB. Dois casos do grupo PP evoluíram com capsulite adesiva e, em apenas um dos casos do grupo HIB, o parafuso distal ficou saliente. Ocorreu neuropraxia do nervo cutâneo lateral do antebraço em um dos casos do grupo HIB que regrediu em três dias. Não houve diferença entre os grupos com relação ao tempo total da cirurgia. O tempo de utilização da radioscopia no ato operatório foi maior no grupo HIB. Houve semelhança entre os dois métodos de fixação nos resultados referentes à dor, à função, à flexão ativa e à força de flexão na articulação do ombro e também com relação à dor, mobilidade, força muscular e estabilidade na articulação do cotovelo. Segundo os critérios da UCLA para o ombro, obtivemos resultados excelentes e bons em 85,7% no grupo operado com placa em ponte e 79% no grupo com haste intramedular bloqueada e de acordo com os critérios de Broberg e Morrey para o cotovelo, obtivemos resultados excelentes e bons em 85,7% no grupo operado com placa em ponte e 90,5% no grupo com haste intramedular bloqueada. Na avaliação subjetiva, duas pacientes, uma do grupo HIB e outra do PP, não ficaram satisfeitas. Conclusão: Não houve diferença no resultado clínico e radiográfico entre os dois métodos / The purpose of the study is to compare clinical and radiographic outcomes between nonreamed locked intramedullary nail and bridging plate for the treatment of humeral shaft fracture. Forty humeral shaft fractures in 39 patients, A, B or C AO types were treated between June 2003 and December 2007. The cases were randomly assigned into two groups being 21 fractures fixed by a 4.5 mm bridging plate, and 19 by nonreamed intramedullary locking nail. Two cases had open fractures, one Gustilo type II, the other type IIIa. Twenty five patients were male (64%), ages ranging from 19 to 75 years old (mean age 41 years and 10 months). The right side was treated in 22 patients (55%) and fall was the most frequent cause of fracture (46%). The minimal period of follow-up was six months and the maximum was 60 months for the bridging plate group (mean=34.5 months) and ranged from eight to 58 months (mean=27months) for the nail group. Only one case from the nail group presented a nonunion. One case, in the plate group, developed a deep infection, and another one, in the nail group, had a superficial infection. Two cases of the bridging plate group had adhesive capsulites and in one case of the nail group the distal screw became prominent. A transient neuropraxis of the antebrachial lateral cutaneous nerve was found in one case of the nail group, but it recovered in three days. There were no differences between the groups concerning pain, function, active flexion and strength of flexion of the shoulder, as well as pain, range of motion, muscle strength, and stability of the elbow. According to the UCLA score, we had 85.7% excellent and good results in the plate group and 79% in the nail group. According to Broberg and Morrey score for the elbow, we had 85.7% excellent and good results in the plate group and 90.5% in the nail group. Just one patient, from the nail group, was not satisfied with the final result, according to subjective criteria. In conclusion, there were no differences in the final clinical and radiographic results between the two methods of fixation

Made available in DSpace on 2017-07-24T19:22:05Z (GMT). No. of bitstreams: 1 THAYNARA BOING.pdf: 2103458 bytes, checksum: e706074b69bce3f72ba788d2a4560bc1 (MD5) Previous issue date: 2017-04-26 / Coordenação de Aperfeiçoamento de Pessoal de Nível Superior / The aim of this systematic review was to compare the clinical effectiveness of non-carious cervical restorations with glass ionomer cement /resin-modified glass ionomer cement (GIC/RMGIC) or composite resin (CR). The following factors were analyzed: retention rates, color, surface texture, marginal adaptation, marginal discoloration and secondary caries. Methods:According to the PRISMA guidelines, systematic review was undertaken using a selection process in two phases, different references were identified and articles were included for qualitative analysis and were included in a meta-analysis. The authors searched the following electronic database: Cochrane, Lilacs, BBO, Pubmed, Scopus and Web Of Science. Additional search of grey literature was performed. Were also searched the abstracts from the IADR (1990-2015), ongoing trials in trials registries, the CAPES database for theses and the ProQuest database for theses and dissertations. We included only randomized clinical trials. Quality of the evidence for each outcome was assessed using the GRADE tool. Results: A total of 1530 articles were identified, but only 19 articles from 15 studies remained for analysis, which were all judged at “unclear” risk of bias. Ten of the 15 studies evaluated resin-modifed glass ionomer cements, (GIC/RMGIC) that showed higher retention rates in all follow-ups (1 to 3 years; p < 0.0001 and at 5 years; p< 0.00001). No difference was observed for marginal discoloration, marginal adaptation and secondary caries in all followups (p > 0.05). CR showed better color match than GIC/RMGIC only at 2 years (p = 0.03). Higher surface texture was observed in GIC/RMGIC in all follow-ups (at 1 year p= 0.0003; at 3 years p = 0.0004). Quality of evidence was graded as moderate or low due to the unclear risk of bias and imprecision in some outcomes. Conclusions: The retention rates of GIC/RMGIC were superior to composite resins in all study follow-ups, but a higher surface texture was observed in the GIC/RMGIC compared to CR. / Comparar a efetividade clínica de restaurações cervicais não cariosas com cimento de ionômero de vidro / cimento de ionômero de vidro modificado por resina (CIV/CIVMR) ou à base de resina composta (RC). Por meio de revisão sistemática da literatura, os seguintes fatores foram analisados: taxas de retenção, cor, textura de superfície, adaptação marginal, descoloração marginal e cárie secundária. Métodos: De acordo com a orientação do PRISMA, a revisão sistemática foi realizada utilizando um processo de seleção em duas fases, identificaram-se diferentes referências e os artigos foram incluídos para uma análise qualitativa e posteriormente meta– análises. Os autores pesquisaram nas seguintes bases de dados: Cochrane, Lilacs e BBO, Pubmed, Scopus e Web Of Science. Uma pesquisa adicional na literatura cinzenta foi realizada. Foram pesquisados também os resumos do IADR (1990-2015), os ensaios em andamento nos registros de ensaios clínicos, as bases de dados CAPES e ProQuest para teses e dissertações. Foram incluídos apenas ensaios clínicos randomizados. A qualidade da evidência para cada resultado foi avaliada usando a ferramenta GRADE. Resultados: Foram identificados 1530 artigos, mas apenas 19 artigos de 15 estudos (4 de acompanhamento de estudos anteriores) permaneceram para análise, os quais foram todos julgados com risco de viés "moderado". Dez dos 15 estudos avaliaram CIVMR. Os CIV/CIVMR apresentaram maiores taxas de retenção em todos os seguimentos (1 a 3 anos, p <0,0001 e 5 anos, p <0,00001). Não houve diferença para descoloração marginal, adaptação marginal e cárie secundária em todos os seguimentos (p> 0,05). A RC mostrou melhor estabilidade de cor do que CIV/CIVMR apenas aos 2 anos (p = 0,03). Observou-se maior rugosidade no CIV/CIVMR em todos os acompanhamentos (1 ano p = 0,0003, aos 3 anos p = 0,0004). A qualidade da evidência foi classificada como moderada ou baixa, devido ao risco indefinido de viés e imprecisão em alguns resultados. Conclusões: As taxas de retenção de CIV/CIVMR foram superiores às resinas compostas em todos os acompanhamentos do estudo, mas observou-se maior textura superficial nesses CIV/CIVMR em relação às RCs.

Conselho Nacional de Desenvolvimento Científico e Tecnológico / Este estudo teve como objetivo verificar, através de uma revisão sistemática de ensaios clínicos aleatorizados, os benefícios da estimulação elétrica funcional endovaginal ou dos tratamentos conservadores às pacientes com incontinência urinária de esforço, e demonstrar qual modalidade de tratamento conservador apresenta melhores resultados na terapêutica dessas mulheres: a estimulação elétrica funcional endovaginal, em comparação com os cones vaginais ou a realização de exercícios perineais. Para tanto, foram realizadas buscas nas principais bases de dados científicos, por estudos que atendessem a pergunta da pesquisa, tipo de intervenção e tipo de participantes selecionados. Destes, foram selecionados 7 estudos que foram submetidos à análise dos revisores, que avaliaram os seguintes desfechos: episódios de perda urinária, quantificação das perdas urinárias através do pad-test, força da musculatura perineal, qualidade de vida, volume residual, capacidade cistométrica máxima, melhora dos sintomas, satisfação e cura. Todas as terapias pesquisadas apresentaram melhora dos sintomas da incontinência urinária de esforço; no entanto, segundo os desfechos avaliados, apresentaram diferença no resultado comparativo. Quanto às perdas urinárias, ao pad-test e à força da musculatura perineal, a realização dos exercícios pélvicos obteve os melhores resultados. Já a terapia por estimulação elétrica endovaginal e a terapia com os cones apresentaram resultados semelhantes, não sendo encontrada diferença significativa em nenhum dos desfechos analisados. De acordo com os achados obtidos nesta revisão sistemática, entendemos que o tratamento pela estimulação elétrica traz benefícios às pacientes com incontinência urinária de esforço. Os exercícios pélvicos demonstraram ser a terapia que reduz mais significativamente os sintomas ocasionados por esta condição / This study aimed to verify, through a systematic review of randomized clinical trials, if the endovaginal functional electrical stimulation provides or not benefits to patients with stress urinary incontinence, and show what kind of conservative treatment produces better results in the treatment of these women: endovaginal functional electrical stimulation, vaginal cones or perineal exercises. To do so, we searched in major scientific databases for studies that met the research question, type of intervention and type of selected participants. Of these, seven studies were selected and analyzed by the reviewers who assessed the following outcomes: frequency of urinary leakage, quantification of urinary leakage through the pad-test, perineal muscle strength, quality of life, residual volume, maximum cystometric capacity, improvement, satisfaction and healing. All therapies surveyed showed improvement of symptoms of stress urinary incontinence; however, according to the outcome parameters, they showed differences in the comparative result. As for urinary leakage, the pad-test and strength of the perineal muscles, the pelvic exercises achieved the best results. The electrical stimulation therapy and transvaginal cone therapy showed similar results, no significant difference was found in any of the outcomes. According to the findings of this systematic review, we believe that treatment by electrical stimulation is beneficial to patients with stress urinary incontinence. The pelvic exercises have proven to be the therapy that more significantly reduces the symptoms caused by this condition

Conselho Nacional de Desenvolvimento Científico e Tecnológico / Este estudo teve como objetivo verificar, através de uma revisão sistemática de ensaios clínicos aleatorizados, os benefícios da estimulação elétrica funcional endovaginal ou dos tratamentos conservadores às pacientes com incontinência urinária de esforço, e demonstrar qual modalidade de tratamento conservador apresenta melhores resultados na terapêutica dessas mulheres: a estimulação elétrica funcional endovaginal, em comparação com os cones vaginais ou a realização de exercícios perineais. Para tanto, foram realizadas buscas nas principais bases de dados científicos, por estudos que atendessem a pergunta da pesquisa, tipo de intervenção e tipo de participantes selecionados. Destes, foram selecionados 7 estudos que foram submetidos à análise dos revisores, que avaliaram os seguintes desfechos: episódios de perda urinária, quantificação das perdas urinárias através do pad-test, força da musculatura perineal, qualidade de vida, volume residual, capacidade cistométrica máxima, melhora dos sintomas, satisfação e cura. Todas as terapias pesquisadas apresentaram melhora dos sintomas da incontinência urinária de esforço; no entanto, segundo os desfechos avaliados, apresentaram diferença no resultado comparativo. Quanto às perdas urinárias, ao pad-test e à força da musculatura perineal, a realização dos exercícios pélvicos obteve os melhores resultados. Já a terapia por estimulação elétrica endovaginal e a terapia com os cones apresentaram resultados semelhantes, não sendo encontrada diferença significativa em nenhum dos desfechos analisados. De acordo com os achados obtidos nesta revisão sistemática, entendemos que o tratamento pela estimulação elétrica traz benefícios às pacientes com incontinência urinária de esforço. Os exercícios pélvicos demonstraram ser a terapia que reduz mais significativamente os sintomas ocasionados por esta condição / This study aimed to verify, through a systematic review of randomized clinical trials, if the endovaginal functional electrical stimulation provides or not benefits to patients with stress urinary incontinence, and show what kind of conservative treatment produces better results in the treatment of these women: endovaginal functional electrical stimulation, vaginal cones or perineal exercises. To do so, we searched in major scientific databases for studies that met the research question, type of intervention and type of selected participants. Of these, seven studies were selected and analyzed by the reviewers who assessed the following outcomes: frequency of urinary leakage, quantification of urinary leakage through the pad-test, perineal muscle strength, quality of life, residual volume, maximum cystometric capacity, improvement, satisfaction and healing. All therapies surveyed showed improvement of symptoms of stress urinary incontinence; however, according to the outcome parameters, they showed differences in the comparative result. As for urinary leakage, the pad-test and strength of the perineal muscles, the pelvic exercises achieved the best results. The electrical stimulation therapy and transvaginal cone therapy showed similar results, no significant difference was found in any of the outcomes. According to the findings of this systematic review, we believe that treatment by electrical stimulation is beneficial to patients with stress urinary incontinence. The pelvic exercises have proven to be the therapy that more significantly reduces the symptoms caused by this condition

O objetivo deste estudo é o de comparar os resultados clínicos e radiográficos do tratamento cirúrgico das fraturas da diáfise do úmero com haste intramedular bloqueada ou placa em ponte. Quarenta fraturas da diáfise do úmero, em 39 pacientes, dos tipos A, B ou C da classificação do grupo A.O., foram tratadas no período compreendido entre junho de 2003 e dezembro de 2007. Destas, após seleção por sorteio, 21 fraturas foram submetidas à osteossíntese com placas em ponte de 4,5 mm e parafusos (grupo PP) e 19 com hastes intramedulares bloqueadas não fresadas (grupo HIB). Duas eram fraturas expostas, uma do tipo II e outra do tipo III-a de Gustilo. Vinte e cinco pacientes eram do sexo masculino (64%) e a idade variou de 19 a 75 anos (idade média de 41 anos e 10 meses). O lado direito foi acometido em 22 pacientes (55%) e a queda, o mecanismo de trauma mais freqüente (46%). O tempo mínimo de seguimento foi de seis meses e o máximo de 60 meses para o grupo PP (M=34,5 meses) e de oito e 58 meses (M=27meses) para o grupo HIB. Em apenas um caso, operado com haste intramedular bloqueada, não houve a consolidação. Houve um caso de infecção profunda no grupo PP e um de infecção superficial no grupo HIB. Dois casos do grupo PP evoluíram com capsulite adesiva e, em apenas um dos casos do grupo HIB, o parafuso distal ficou saliente. Ocorreu neuropraxia do nervo cutâneo lateral do antebraço em um dos casos do grupo HIB que regrediu em três dias. Não houve diferença entre os grupos com relação ao tempo total da cirurgia. O tempo de utilização da radioscopia no ato operatório foi maior no grupo HIB. Houve semelhança entre os dois métodos de fixação nos resultados referentes à dor, à função, à flexão ativa e à força de flexão na articulação do ombro e também com relação à dor, mobilidade, força muscular e estabilidade na articulação do cotovelo. Segundo os critérios da UCLA para o ombro, obtivemos resultados excelentes e bons em 85,7% no grupo operado com placa em ponte e 79% no grupo com haste intramedular bloqueada e de acordo com os critérios de Broberg e Morrey para o cotovelo, obtivemos resultados excelentes e bons em 85,7% no grupo operado com placa em ponte e 90,5% no grupo com haste intramedular bloqueada. Na avaliação subjetiva, duas pacientes, uma do grupo HIB e outra do PP, não ficaram satisfeitas. Conclusão: Não houve diferença no resultado clínico e radiográfico entre os dois métodos / The purpose of the study is to compare clinical and radiographic outcomes between nonreamed locked intramedullary nail and bridging plate for the treatment of humeral shaft fracture. Forty humeral shaft fractures in 39 patients, A, B or C AO types were treated between June 2003 and December 2007. The cases were randomly assigned into two groups being 21 fractures fixed by a 4.5 mm bridging plate, and 19 by nonreamed intramedullary locking nail. Two cases had open fractures, one Gustilo type II, the other type IIIa. Twenty five patients were male (64%), ages ranging from 19 to 75 years old (mean age 41 years and 10 months). The right side was treated in 22 patients (55%) and fall was the most frequent cause of fracture (46%). The minimal period of follow-up was six months and the maximum was 60 months for the bridging plate group (mean=34.5 months) and ranged from eight to 58 months (mean=27months) for the nail group. Only one case from the nail group presented a nonunion. One case, in the plate group, developed a deep infection, and another one, in the nail group, had a superficial infection. Two cases of the bridging plate group had adhesive capsulites and in one case of the nail group the distal screw became prominent. A transient neuropraxis of the antebrachial lateral cutaneous nerve was found in one case of the nail group, but it recovered in three days. There were no differences between the groups concerning pain, function, active flexion and strength of flexion of the shoulder, as well as pain, range of motion, muscle strength, and stability of the elbow. According to the UCLA score, we had 85.7% excellent and good results in the plate group and 79% in the nail group. According to Broberg and Morrey score for the elbow, we had 85.7% excellent and good results in the plate group and 90.5% in the nail group. Just one patient, from the nail group, was not satisfied with the final result, according to subjective criteria. In conclusion, there were no differences in the final clinical and radiographic results between the two methods of fixation

Randomized controlled trials (RCTs) are the hallmark of evidence-based medicine and form the basis for translating research data into clinical practice. This review summarizes commonly applied designs and quality indicators of RCTs to provide guidance in interpreting and critically evaluating clinical research data. It further reflects on the principle of equipoise and its practical applicability to clinical science with an emphasis on critical care and neurological research. We performed a review of educational material, review articles, methodological studies, and published clinical trials using the databases MEDLINE, PubMed, and ClinicalTrials.gov. The most relevant recommendations regarding design, conduction, and reporting of RCTs may include the following: 1) clinically relevant end points should be defined a priori, and an unbiased analysis and report of the study results should be warranted, 2) both significant and nonsignificant results should be objectively reported and published, 3) structured study design and performance as indicated in the Consolidated Standards of Reporting Trials statement should be employed as well as registration in a public trial database, 4) potential conflicts of interest and funding sources should be disclaimed in study report or publication, and 5) in the comparison of experimental treatment with standard care, preplanned interim analyses during an ongoing RCT can aid in maintaining clinical equipoise by assessing benefit, harm, or futility, thus allowing decision on continuation or termination of the trial.

Le délirium est un état confusionnel aigu se manifestant entre autres par de l’agitation, de la léthargie (APA, 2013). Le délirium survient chez près de la moitié des patients subissant une chirurgie cardiaque malgré les interventions de prévention basées sur des guides de pratique clinique (Gosselt et al., 2015). Les complications associées au délirium sont importantes incluant une augmentation de la durée de séjour et un ralentissement du rétablissement (Inouye, Wastendrop & Saczynski, 2013; Saczynski et al., 2012). Cette étude portait sur le développement et l’évaluation d’une nouvelle intervention infirmière de mentorat visant à faciliter la participation d’un aidant familial dans la gestion du délirium. L’étude portait également sur la validité d’une nouvelle mesure de monitoring du délirium, l’oxymétrie cérébrale. Le but principal de cette étude pilote randomisée était d’évaluer l’acceptabilité et la faisabilité du devis et de l’intervention infirmière de mentorat, ainsi que la validité de l’oxymétrie cérébrale. Le but secondaire était d’évaluer les effets préliminaires de l’intervention. Trente dyades comprenant un patient présentant un délirium post-chirurgie cardiaque et un aidant familial ont été assignées aléatoirement au groupe contrôle recevant les soins usuels ou au groupe recevant l’intervention infirmière. L’intervention, ancrée dans une approche caring, visait à faciliter la transition des aidants dans un rôle participatif auprès de leur proche atteint de délirium ainsi qu’à favoriser le rehaussement de leur sentiment d’efficacité personnelle. L’indicateur principal d’évaluation de l’acceptabilité du devis était l’obtention du consentement d’au moins 75% des aidants approchés pour participer à l’étude. Par la suite, l’acceptabilité et la faisabilité ont été évaluées en se basant sur des critères d’évaluation des études pilotes pour le devis, par exemple, sur des données de recrutement et du domaine de l’évaluation d’interventions infirmières pour l’intervention, par exemple, la satisfaction des participants. Les effets préliminaires de l’intervention pour les patients ont été mesurés au moyen d’un score de sévérité du délirium, du nombre de complications, de la durée du séjour et du rétablissement psychofonctionnel. Auprès des aidants, des scores d’anxiété et d’efficacité personnelle ont été obtenus. Afin de tester la validité de la nouvelle mesure, les valeurs d’oxymétrie cérébrale ont été comparées à des scores de trois échelles d’évaluation du délirium validées. L’indicateur principal d’acceptabilité du devis, a été atteint avec un taux de consentement chez les aidants de 76,9 %. Cependant, le recrutement s’est avéré un grand défi, principalement parce que la prévalence des délirium détectés fut moindre qu’anticipée. L'intervention était acceptable et réalisable, comme en témoigne la participation des aidants familiaux. Les résultats de sévérité du délirium se sont avérés similaires dans les deux groupes, tout comme ceux relatifs aux complications. Les autres mesures de résultats ont présenté une tendance favorisant le groupe intervention dont une durée d’hospitalisation plus courte ainsi qu’un niveau d’anxiété moindre et d’un niveau sentiment d’efficacité personnelle plus élevé chez les aidants. Un effet statistiquement significatif de l’intervention favorisant le groupe intervention a été observé sur le rétablissement psychofonctionnel (p = 0,01). Une relation statistiquement significative entre les valeurs d’oxymétrie cérébrale et la présence et la sévérité du délirium a été observée (p ≤ 0,001). Cette étude contribue à l’avancement des connaissances par la démonstration de l’acceptabilité et la faisabilité d’une intervention pour rehausser la gestion du délirium par un mentorat des aidants familiaux. Une autre contribution réside dans les résultats prometteurs quant à la validité de l’oxymétrie cérébrale comme nouvelle mesure de monitoring du délirium qui pourra rehausser la détection et la gestion du délirium. / Delirium is an acute confusional state accompanied by agitation or lethargy (APA, 2013). Despite the prevention strategies based on clinical practice guidelines, nearly half of the patients undergoing a cardiac surgery will present delirium (Gosselt et al., 2015). Complications of delirium are important and include increased length of stay in addition to a slower recovery (Inouye, Wastendrop & Saczynski, 2013; Saczynski et al., 2012). This study focused, on a new nursing intervention aiming to facilitate participation from a family caregiver in the management of delirium. The study also focused on the validity of a new measure to monitor delirium, cerebral oximetry, a non-invasive measure potentially able to indicate the presence and severity of the delirium. The primary objective of the randomized pilot study was to assess the acceptability and feasibility of the design and nursing interventions, and the validity of cerebral oximetry to monitor delirium. The secondary objective was to assess the preliminary efficacy of the intervention. Thirty dyads including a patient who had post-cardiac surgery delirium and a family caregiver were randomly assigned to either the control group receiving the usual care or a group receiving the experimental nursing interventions. The intervention, rooted in a caring approach, aimed to facilitate family caregivers’ transition to an involved role in delirium management in addition to promoting the enhancement of their self-efficacy. The primary indicator to assess the acceptability of the design was the consent of at least 75 % of family caregivers who were approached to participate in the study. Afterwards, the acceptability and feasibility was were evaluated based on criteria in the field of pilot studies for the study design, for example, on recruitment data, and on criteria in the field of evaluation of nursing interventions for the intervention, for example, the satisfaction of the caregivers . The preliminary effects of the intervention of the patients were measured using a score reflecting delirium severity, the amount of postoperative complications as well as the length of hospital stay and patient’s psycho-functional recovery. Scores for anxiety and self-efficacy were also obtained from the caregivers. In order to test the validity of the new measure of delirium, cerebral oximetry values were compared to scores on three validated delirium rating scales. The primary indicator of the acceptability estimate was achieved with a 76.9 % consent rate among caregivers. However, recruitment has sown itself to be a great challenge, mainly because the number of eligible patients was less than anticipated. The experimental intervention was acceptable and feasible, as evidenced by the participation of the caregivers. Results on delirium severity and complications were similar in the two groups. Results favoring the intervention groups included shorter length of stay and less anxiety along with the added feeling of greater personal effectiveness among caregivers. In addition, a statistically significant effect of the intervention was observed on the psycho-functional recovery favoring the intervention group. (p=0.01). A statistically significant relationship between cerebral oximetry and occurrence and severity of delirium was observed (p ≤ 0.001), supporting the potential of this measure in monitoring the delirium. This study contributes to the advancements of knowledge through the demonstration of the acceptability and feasibility of an intervention to enhance the management of delirium by mentoring caregivers. Another contribution lies in the promising results on the validity of cerebral oximetry as a new monitoring measure of delirium, which has the potential of enhancing delirium detection and management.