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In cluster randomized trials (CRTs), groups are randomized to treatment arms rather than individuals while the outcome is assessed on the individuals within each cluster. Individuals within clusters tend to be more similar than in a randomly selected sample, which poses issues with dependence, which may lead to underestimated standard errors if ignored. To adjust for the correlation between individuals within clusters, two main approaches are used to analyze CRTs: cluster-level and individual-level analysis. In a cluster-level analysis summary measures are obtained for each cluster and then the two sets of cluster-specific measures are compared, such as with a t-test of the cluster means. A mixed model which takes into account cluster membership is an example of an individual-level analysis. We used a simulation study to quantify and compare power and bias of these two methods. We further take into account the effect of missing data. Complete datasets were generated and then data were deleted to simulate missing completely at random (MCAR) and missing at random (MAR) data. A balanced design, with two treatment groups and two time points was assumed. Cluster size, variance components (including within-subject, within-cluster and between-cluster variance) and proportion of missingness were varied to simulate common scenarios seen in practice. For each combination of parameters, 1,000 datasets were generated and analyzed. Results of our simulation study indicate that cluster-level analysis resulted in substantial loss of power when data were MAR. Individual-level analysis had higher power and remained unbiased, even with a small number of clusters.

BACKGROUND: Preoperative anxiety commonly occurs in young children prior to anesthesia induction. This anxiety is associated with poor post-operative outcomes such as increases in emergence delirium occurrence and post-operative pain. Studies have demonstrated varying effectiveness of interventions such as clowns and video games used to engage and distract children from their anxiety. Anesthesiologists at Lucile Packard Children’s Hospital have designed a new screen-based modality, called the Bedside Entertainment Theatre (BERT), to distract children from their anxiety. OBJECTIVE: The aim of this study is to examine the anxiety-relieving efficacy of BERT against a hand-held electronic tablet, another screen-based form of entertainment used to alleviate preoperative anxiety in children at the hospital. METHODS: Children aged 4-10 undergoing non-emergent outpatient surgery at Lucile Packard Children’s Hospital and their primary caregiver were recruited for the study. Measures were taken at 5 timepoints from children, parents, and clinicians: in the preoperative holding area (T1), at entrance to the OR (T2), at induction (T3), after emergence from anesthesia (T4), and at a 1-week follow up (T5). Primary outcomes were preoperative anxiety, assessed by the modified Yale Preoperative Anxiety Scale (mYPAS) and Child Fear Scale (CFS), and induction compliance, assessed by the Induction Compliance Checklist (ICC). Secondary outcomes were emergence delirium, measured by the Pediatric Anesthesia Emergence Delirium Scale (PAED) and post-operative pain, measured by the Parents’ Post-operative Pain Measure (PPPM) and a Memory Recall Interview. Child covariates were temperament, measured by the Emotionality Activity Sociability Temperament Survey (EAS-TS) and the Children’s Behavior Questionnaire- Very Short Form (CBQ-VSF), and state-trait anxiety, measured by the Child State-Trait Anxiety Inventory (STAIC). Caregiver covariates were state-trait anxiety, measured by the State-Trait Anxiety Inventory (STAI) and caregiver pain catastrophizing about their child, measured by the Pain Catastrophizing Scale- Parent State (PCS-P State). This study is currently ongoing and plans to recruit 60 participants. Parent, child, and clinician satisfaction with usage of either intervention was also assessed. RESULTS: There were no significant differences between mean preoperative anxiety scores of BERT and tablet users at all pre-induction timepoints. There was a significant increase in mean preoperative anxiety scores in BERT users from T1 to T2 and T1 to T3. There was also a significant increase in mean preoperative anxiety scores from T1 to T3 for tablet users. There were no other significant differences in primary and secondary outcomes between interventions. Only post-surgery PCS-P State scores for BERT users correlated with mYPAS scores at T3 (p < 0.05). No other measured covariates correlated with preoperative anxiety scores (p > 0.05). CONCLUSIONS: Although preliminary results do not show differences between the interventions in relieving preoperative anxiety, there may be potential insights gained in how both interventions affect anxiety at different preoperative timepoints. Statistical analysis with the full sample population will be necessary to draw stronger conclusions. / 2018-07-11T00:00:00Z

Unique characteristics of cluster randomized trials (CRTs) complicate the interpretation of standard research ethics guidelines. Variable interpretation by research ethics committees may further complicate review and conduct. An international web-based survey was administered to corresponding authors of 300 randomly sampled CRT publications. We investigated ethics review and consent practices, investigator experiences with ethics review, and the perceived need for CRT-specific ethics guidelines. The response rate was 64%. Ethics review and consent were under-reported in publications. Ethics approval was obtained in 91%, and consent from individual and cluster level participants in 79% and 82% of trials. Consent varied by level of experimental intervention, data collection, and cluster size. Respondents cited variability among ethics committees (46%), and negative impacts of ethics review on their studies (38%). The majority perceived a need for ethics guidelines (73%), and guidance for ethics committees (70%). CRT-specific ethics guidelines are required to ensure practices meet ethical standards.

No description available.

Unique characteristics of cluster randomized trials (CRTs) complicate the interpretation of standard research ethics guidelines. Variable interpretation by research ethics committees may further complicate review and conduct. An international web-based survey was administered to corresponding authors of 300 randomly sampled CRT publications. We investigated ethics review and consent practices, investigator experiences with ethics review, and the perceived need for CRT-specific ethics guidelines. The response rate was 64%. Ethics review and consent were under-reported in publications. Ethics approval was obtained in 91%, and consent from individual and cluster level participants in 79% and 82% of trials. Consent varied by level of experimental intervention, data collection, and cluster size. Respondents cited variability among ethics committees (46%), and negative impacts of ethics review on their studies (38%). The majority perceived a need for ethics guidelines (73%), and guidance for ethics committees (70%). CRT-specific ethics guidelines are required to ensure practices meet ethical standards.

Submitted by isabela.moljf@hotmail.com (isabela.moljf@hotmail.com) on 2017-08-11T12:21:13Z No. of bitstreams: 1 josemariamendesmoraes.pdf: 291711 bytes, checksum: d0295e24bf772314c091cc1d84a137a5 (MD5) / Approved for entry into archive by Adriana Oliveira (adriana.oliveira@ufjf.edu.br) on 2017-08-11T12:55:30Z (GMT) No. of bitstreams: 1 josemariamendesmoraes.pdf: 291711 bytes, checksum: d0295e24bf772314c091cc1d84a137a5 (MD5) / Made available in DSpace on 2017-08-11T12:55:30Z (GMT). No. of bitstreams: 1 josemariamendesmoraes.pdf: 291711 bytes, checksum: d0295e24bf772314c091cc1d84a137a5 (MD5) Previous issue date: 2009-12-18 / Na pancreatite aguda (PA), a necessidade de restringir gordura durante a realimentação ainda não foi estudada. A tese é que iniciar a realimentação oral com dieta sólida completa após PA seria seguro e poderia resultar em um tempo menor de hospitalização. O objetivo deste trabalho foi explorar a segurança e o tempo de internação quando uma dieta sólida completa é utilizada como refeição inicial após quadro de PA leve, comparando com outras duas dietas: líquida e pastosa. Pacientes com PA leve foram randomizados para receber uma entre três dietas: líquida clara, pastosa ou sólida completa como refeição inicial durante realimentação oral. A progressão da dieta e a alta hospitalar foram determinadas por médicos não membros da equipe do ensaio. Os pacientes foram monitorados diariamente para recorrência de dor abdominal (endpoint primário), tolerância à dieta, tempo de internação (endpoint secundário) e durante sete dias após a alta para registrar a frequência da recorrência de dor. Um total de 210 pacientes foi avaliado, 70 em cada tipo de dieta. Baseado no protocolo, não houve diferença na frequência da recorrência de dor durante a realimentação entre os três tipos de dieta: 20% para a dieta líquida, 17% para a pastosa e 21% para a sólida completa (P=0,80). Os pacientes que receberam uma dieta sólida completa sem recorrência de dor abdominal tiveram um tempo menor de internação (mediano de -1,5 dia) quando comparados com os que receberam a dieta pastosa ou líquida (P=0,000). A realimentação com dieta sólida completa após PA leve foi bem tolerada e resultou em um tempo menor de internação em pacientes sem recorrência de dor abdominal. / In acute pancreatitis (AP) the need for fat restriction during refeeding has not been studied. The thesis is that to start oral refeeding with a full solid diet after mild AP would be safe and might result in a shorter length of hospitalization. The objective of this study was to explore the safety and length of hospital stay when a full solid diet is used as the initial meal after a mild AP comparing to two other diets: liquid and pasty. Patients with mild AP were randomized to receive one of three diets: clear liquid, pasty or full solid as the initial meal during oral refeeding. Diet progression and hospital discharge were determined by non-members of the trial team. Patients were monitored daily for abdominal pain recurrence (primary endpoint), diet tolerance, length of hospitalization (secondary endpoint) and during seven days after discharge to record the pain recurrence rates. A total of 210 patients was evaluated, 70 in each type of diet. Based on the protocol, there was no difference in pain recurrence rates during refeeding between the three diet types: 20% for liquid diet, 17% for pasty and 21% for full solid (P=0.80). The patients who received a full solid diet without abdominal pain recurrence had a shorter length of hospitalization (median of -1.5 days) when compared with those who received the liquid or pasty diets (P=0.000). Oral refeeding with a full solid diet after mild AP was well tolerated and resulted in a shorter length of hospitalization in patients without abdominal pain recurrence.

Unique characteristics of cluster randomized trials (CRTs) complicate the interpretation of standard research ethics guidelines. Variable interpretation by research ethics committees may further complicate review and conduct. An international web-based survey was administered to corresponding authors of 300 randomly sampled CRT publications. We investigated ethics review and consent practices, investigator experiences with ethics review, and the perceived need for CRT-specific ethics guidelines. The response rate was 64%. Ethics review and consent were under-reported in publications. Ethics approval was obtained in 91%, and consent from individual and cluster level participants in 79% and 82% of trials. Consent varied by level of experimental intervention, data collection, and cluster size. Respondents cited variability among ethics committees (46%), and negative impacts of ethics review on their studies (38%). The majority perceived a need for ethics guidelines (73%), and guidance for ethics committees (70%). CRT-specific ethics guidelines are required to ensure practices meet ethical standards.

Les taux de césarienne sont en constante croissance dans le monde. Ces dernières années, on assiste à une augmentation sans cesse des taux hospitaliers d’accouchement par césarienne dans les pays à faible ressource malgré les recommandations de l’Organisation mondiale de la santé de ne pas dépasser 10 à 15 %. En Afrique au sud du Sahara, en particulier au Sénégal et au Mali, des politiques de subvention de la césarienne ont été introduites à l’échelle nationale à partir de 2005. Ces mesures ont contribué à l’augmentation de l’utilisation des services de maternité et des taux de césarienne. Si l’accessibilité financière à la césarienne a été améliorée substantiellement, la qualité n’a pas toujours suivi. Or, une augmentation trop importante des taux de césarienne peut avoir des effets négatifs sur la santé maternelle et périnatale. Par exemple, l’augmentation des taux institutionnels de césarienne au dessus de 10% en Amérique latine était associée à une augmentation de la mortalité maternelle et périnatale hospitalière. Trois ans après la mise en œuvre des politiques d’exemption des césariennes, le Programme Gesta international (PGI) a été mis en œuvre pour améliorer la qualité des soins obstétricaux dans 23 hôpitaux de référence au Sénégal et au Mali. Ce programme se basait sur l’audit clinque et la formation médicale continue du personnel sur les pratiques optimales en matière de soins intrapartum. Un essai contrôlé randomisé en grappe (essai QUARITE) a été mise en œuvre en 2007-2011 pour tester l’effet du PGI sur la mortalité maternelle hospitalière au Sénégal et au Mali. Initialement prévu pour améliorer la qualité des soins intra-partum, je me suis posé la question de l’efficacité de ce programme sur la pratique et les résultats de la césarienne. Les résultats de notre étude montrent que le PGI a permis de réduire l’évolution des taux de césarienne institutionnels dans les hôpitaux du groupe d’intervention comparativement à l’évolution dans le groupe contrôle. Par ailleurs, nous avons trouvé que le PGI a été plus efficace, en terme de réduction de la mortalité maternelle, parmi les femmes césarisées que parmi celles qui ont accouché par voie vaginale. Nous avons donc recommandé que des programmes d’amélioration de la qualité des soins soient mis en œuvre pour accompagner les politiques de subvention en cours dans la plupart des pays en Afrique au sud du Sahara et limiter ainsi l’utilisation excessive des césariennes dans ces pays. / Cesarean rates are rising steadily worldwide. In recent years, there has been an increasing cesarean rates in low-resource countries despite the World Health Organization recommended to not exceed 10-15%. In Senegal and Mali free cesarean policies were implemented nationally since 2005 and have contributed to increase the access to cesarean section. Access to cesarean deliveries has been improved substantially but quality of care has not always followed. However, excessive increase in cesarean section rates can have negative impacts on maternal and perinatal health. In Latin America, Asia, and Africa, several studies have shown an intrinsic risk of maternal and neonatal mortality associated with cesareans regardless of the initial health status of the mother or fetus. For example, the increase in hospital-based cesarean rates above 10% in Latin America was associated with an increase risk of maternal and perinatal mortality.Three years after the implementation of cesarean sections free policies, The Advances in Labour and Risk Management (ALARM) international program was implemented to improve the quality of obstetric care in 23 referral hospitals in Senegal and Mali. This program was based on maternal death review and staff training on best practices for intrapartum care. A randomized controlled cluster trial (QUARITE trial) was implemented in 2007-2011 to assess the effectiveness of the ALARM international program on in-hospital maternal mortality in Senegal and Mali. Initially planned to improve quality of Emergency Obstetric and Neonatal Care (EmONC), we assumed that this program was also effective on the quality of cesarean delivery.Results showed that the ALARM international program slowed down the trends of hospital-based cesarean rates in the 23 participating centers of the intervention group compared to the changes observed in the control group. Furthermore, we found that the program was more effective on maternal mortality among women who delivered by cesarean section than among women who delivered vaginally. We recommend that quality improvement strategies should support free cesarean policies to limit the excessive use of cesarean delivery.