Bringing data monitoring committee charters into the sunlight.

Clinical trials investigating novel or high risk interventions, or studying vulnerable participants, often use a data monitoring committee to oversee the progress of the trial. The data monitoring committee serves both an ethical and a scientific function, by protecting the interests of trial participants while ensuring the integrity of the trial results. A data monitoring committee charter, which typically describes the procedures by which data monitoring committees operate, contains details about the data monitoring committee's organizational structure, membership, meeting frequency, sequential monitoring guidelines, and the overall contents of data monitoring committee reports for interim review. These charters, however, are generally not reviewed by outside entities and are rarely publicly available. The result is that a key component of trial oversight remains in the dark. We recommend that ClinicalTrials.gov modify its system to allow uploading of data monitoring committee charters, as is already possible for other important study documents and that clinical trialists take advantage of this opportunity to voluntarily upload the data monitoring committee charter for trials that have one. The resulting cache of publicly available data monitoring committee charters should provide important insights for those interested in a particular trial, as well as for meta-researchers who wish to understand and potentially improve how this important component of trial oversight is actually being applied.

Effectiveness of a Combined Toothbrushing Technique on Cariogenic Dental Biofilm in Relation to Stainless Steel and Elastomeric Ligatures in Orthodontic Patients: A Randomized Clinical Trial.

Increased dental biofilm commonly occurs during orthodontic treatment. The aim of this study was to evaluate the effect of a combined toothbrushing method on dental biofilm cariogenicity in patients with stainless steel (SSL) and elastomeric (EL) ligatures. At baseline (T1), 70 participants were randomized (1:1 ratio) to the SSL or EL group. Dental biofilm maturity was evaluated using a three-color-disclosing dye. The participants were instructed to brush their teeth using a combined horizontal-Charters-modified Bass technique. Dental biofilm maturity was reassessed at the 4-week follow-up (T2). We found that at T1, new dental biofilm was the highest, followed by mature and cariogenic dental biofilm in the SSL group (p < 0.05). In the EL group, cariogenic dental biofilm was highly observed, followed by mature and new dental biofilm (p < 0.05). After intervention, cariogenic dental biofilm significantly decreased in both groups (p < 0.05). Moreover, a marked decrease in cariogenic dental biofilm was observed in the EL group compared with the SSL group (p < 0.05). However, the change in mature dental biofilm in the groups was similar (p > 0.05). Our results demonstrated that the combined toothbrushing method reduced cariogenic dental biofilm in the SSL and EL groups.

Translating time-based research into team interventions: An actionable, evidence-based approach.

Temporal challenges are not only contextual in nature but manifest internally in teams when members enter the team with different temporal orientations (e.g., time urgency and pacing style). Researchers have demonstrated that temporal diversity has important implications for key team outcomes (performance, timeliness, and team conflict) across a range of samples and countries. Unfortunately, the practical implications of this research have yet to be unpacked. We respond to this need by developing an approach to translate temporal diversity research studies into actionable, evidence-based team interventions. Because journal articles are often deficient on actionable steps, whereas practitioner-friendly outlets tend to be deficient on scientific rigor, incorporating both criteria necessitates merging these literatures. Specifically, we delineate four main steps: (1) identify significant moderators, (2) match the moderators to scientifically based interventions, (3) design intervention tools with specific, actionable procedures, and (4) evaluate the effectiveness of the intervention tools by designing research studies. We believe the process we outline to marry actionable and evidence-based benchmarks is applicable to other research domains in team science beyond temporal research. It is our hope that this research will be a catalyst for further exploration of interventions that can help team members navigate temporal differences.

A biocodicological analysis of the medieval library and archive from Orval Abbey, Belgium.

Biocodicological analysis of parchments from manuscript books and archives offers unprecedented insight into the materiality of medieval literacy. Using ZooMS for animal species identification, we explored almost the entire library and all the preserved single leaf charters of a single medieval Cistercian monastery (Orval Abbey, Belgium). Systematic non-invasive sampling of parchment collagen was performed on every charter and on the first bifolium from every quire of the 118 codicological units composing the books (1490 samples in total). Within the genuine production of the Orval scriptorium (26 units), a balanced use of calfskin (47.1%) and sheepskin (48.5%) was observed, whereas calfskin was less frequent (24.3%) in externally produced units acquired by the monastery (92 units). Calfskin was preferably used for higher quality manuscripts while sheepskin tends to be the standard choice for 'ordinary' manuscript book production. This finding is consistent with thirteenth-century parchment accounts from Beaulieu Abbey (England) where calfskin supply was more limited and its price higher. Our study reveals that the making of archival documents does not follow the same pattern as the production of library books. Although the five earliest preserved charters are made of calfskin, from the 1230s onwards, all charters from Orval are written on sheepskin.

Preterm newborn's postnatal growth patterns: how to evaluate them.

OBJECTIVES: There are several factors that influence the postnatal growth of preterm infants. It is crucial to define how to evaluate the growth rate of each preterm child and its individual trajectory, the type of growth curve, either with parameters of prescriptive curves for healthy preterm infants with no morbidities or, in the case of preterm infants and their "bundle of vulnerabilities", growth curves that may represent how they are actually growing, with the aim of directing appropriate nutritional care to each gestational age range. DATA SOURCES: The main studies with growth curves for growth monitoring and the appropriate nutritional adjustments that prioritized the individual trajectory of postnatal growth rate were reviewed. PubMed and Google Scholar were searched. DATA SYNTHESIS: The use of longitudinal neonatal data with different gestational ages and considering high and medium-risk pregnancies will probably be essential to evaluate the optimal growth pattern. CONCLUSIONS: Prioritizing and knowing the individual growth trajectory of each preterm child is an alternative for preterm infants with less than 33 weeks of gestational age. For larger preterm infants born at gestational age >33 weeks, the Intergrowth 21st curves are adequate.

Preterm newborn's postnatal growth patterns: how to evaluate them / Padrões de crescimento pós-natal do recém-nascido prematuro: como avaliar

Abstract Objectives: There are several factors that influence the postnatal growth of preterm infants. It is crucial to define how to evaluate the growth rate of each preterm child and its individual trajectory, the type of growth curve, either with parameters of prescriptive curves for healthy preterm infants with no morbidities or, in the case of preterm infants and their "bundle of vulnerabilities", growth curves that may represent how they are actually growing, with the aim of directing appropriate nutritional care to each gestational age range. Data sources: The main studies with growth curves for growth monitoring and the appropriate nutritional adjustments that prioritized the individual trajectory of postnatal growth rate were reviewed. PubMed and Google Scholar were searched. Data synthesis: The use of longitudinal neonatal data with different gestational ages and considering high and medium-risk pregnancies will probably be essential to evaluate the optimal growth pattern. Conclusions: Prioritizing and knowing the individual growth trajectory of each preterm child is an alternative for preterm infants with less than 33 weeks of gestational age. For larger preterm infants born at gestational age >33 weeks, the Intergrowth 21st curves are adequate.

Resumo Objetivos: Inúmeros são os fatores que influenciam o crescimento pós-natal de prematuros. É fundamental a definição de como avaliar velocidade de crescimento de cada criança nascida prematura e sua trajetória individual, o tipo de curva de crescimento, seja com parâmetros de curvas prescritivas para prematuros saudáveis e sem morbidades ou no caso de um prematuro e seu "pacote de vulnerabilidades", curvas de crescimento que possam representar como eles realmente crescem, com a finalidade de direcionar o cuidado nutricional apropriado a cada faixa de idade gestacional. Fonte de dados: Foram revisados os principais estudos com curvas de crescimento na monitoração do crescimento e nos ajustes nutricionais apropriados que priorizaram a trajetória individual da velocidade de crescimento pós-natal. Foram consultados PubMed e Google Scholar. Síntese dos dados: O uso de dados neonatais longitudinais com diferentes idades gestacionais e considerando gestações de alto e médio risco provavelmente será fundamental para avaliar o padrão ótimo de crescimento. Conclusões: Priorizar e conhecer a trajetória individual de crescimento de cada criança nascida prematura é opção para prematuros com menos de 33 semanas. Para prematuros maiores, nascidos com idade gestacional acima de 33 semanas, as curvas Intergrowth 21 st são adequadas.

The right to refuse treatment: an application of the economic principles of decision-making under uncertainty.

When courts do not defer to professional medical judgement alternative ways must be found to make treatment decisions for persons who are deemed incompetent. Rather than impose the preferences of society upon the mentally ill individual, US courts favoured alternative procedures such as substituted judgement and the principle of the patient's best interest.

United States v. Charters.

KIE: The government sought an order permitting medical personnel at the Federal Correctional Institution at Butner, North Carolina, to administer antipsychotic medication to an involuntarily committed psychiatric patient without his consent. A U.S. District Court order permitting the forcible medication was appealed by the patient, and the order was reversed and remanded by a Court of Appeals panel. On rehearing, the Court of Appeals, Fourth Circuit, returned the case to the lower court for reconsideration with the following directions: (1) base-line decisions to medicate should be made by medical personnel, with judicial review available to guard against arbitrariness; (2) the district court did not err in approving forcible medication at the time, but medical personnel now should reevaluate the situation; and (3) the district court for Butner, N.C., would be the proper court to review future medical decisions.^ieng

United States v. Charters.

KIE: The Fourth Circuit examined the legal grounds on which a medically incompetent patient confined in a federal treatment facility can be forcibly medicated with antipsychotic drugs. Distinguishing the case from Youngberg v. Romeo, in which the Supreme Court recommended deference to the professional judgment of the mental institution, the Fourth Circuit offered a more protective test focusing on the rationality of the patient's reasons for refusing the medication. If the patient's incompetence precludes a rational decision, the court should substitute its judgment based on evidence of what the patient would have decided if competent, or on what is in the patient's best interests. In reaching its conclusion, the court was concerned that mentally ill patients may still be competent to make decisions concerning their medical care, and that antipsychotic drugs can cause serious injury and infringe on an individual's freedom of thought.^ieng