Cognitive behaviour therapy for adolescents with eating disorders: An effective alternative to the disease-based treatments

Several clinical services offer eclectic multidisciplinary treatments with no evidence of efficacy and effectiveness for adolescents with eating disorders. These treatments are usually based on the ‘disease model’ of eating disorders. The model postulates that eating disorders are the result of a specific disease (i.e., anorexia nervosa, bulimia nervosa or other eating disorders), and patients are considered not to have control of their illness. Therefore, they need the external control of parents and/or health professionals. In this model, the patients adopt a passive role in the treatment. On the contrary, enhanced cognitive behaviour therapy (CBT-E) for adolescents is based on a ‘psychological model’ of eating disorders. Patients are helped to understand the psychological mechanisms that maintain their eating disorder and are ‘actively’ involved in the recovery process. Clinical studies showed that more than 60% of adolescent patients who complete the treatment achieve a full response at 12-month follow-up. The treatment is well accepted by young people and their parents, and its collaborative nature is well suited to ambivalent young patients who may be particularly concerned about control issues and for parents who cannot participate in all treatment sessions.

Application of Real-World Data to External Control Groups in Oncology Clinical Trial Drug Development

Randomized controlled trials (RCTs) that assess overall survival are considered the “gold standard” when evaluating the efficacy and safety of a new oncology intervention. However, single-arm trials that use surrogate endpoints (e.g., objective response rate or duration of response) to evaluate clinical benefit have become the basis for accelerated or breakthrough regulatory approval of precision oncology drugs for cases where the target and research populations are relatively small. Interpretation of efficacy in single-arm trials can be challenging because such studies lack a standard-of-care comparator arm. Although an external control group can be based on data from other clinical trials, using an external control group based on data collected outside of a trial may not only offer an alternative to both RCTs and uncontrolled single-arm trials, but it may also help improve decision-making by study sponsors or regulatory authorities. Hence, leveraging real-world data (RWD) to construct external control arms in clinical trials that investigate the efficacy and safety of drug interventions in oncology has become a topic of interest. Herein, we review the benefits and challenges associated with the use of RWD to construct external control groups, and the relevance of RWD to early oncology drug development.

Using Observational Study Data as an External Control Group for a Clinical Trial: an Empirical Comparison of Methods to Account for Longitudinal Missing Data

Background: Observational data are increasingly being used to conduct external comparisons to clinical trials. In this study, we empirically examined whether different methodological approaches to longitudinal missing data affected study conclusions in this setting. Methods: We used data from one clinical trial and one prospective observational study, both Norwegian multicenter studies including patients with recently diagnosed rheumatoid arthritis and implementing similar treatment strategies, but with different stringency. A binary disease remission status was defined at 6, 12, and 24 months in both studies. After identifying patterns of longitudinal missing outcome data, we evaluated the following five approaches to handle missingness: analyses of patients with complete follow-up data, multiple imputation (MI), inverse probability of censoring weighting (IPCW), and two combinations of MI and IPCW. Results: We found a complex non-monotone missing data pattern in the observational study (N=328), while missing data in the trial (N=188) was monotone due to drop-out. In the observational study, only 39.0% of patients had complete outcome data, compared to 89.9% in the trial. All approaches to missing data indicated favorable outcomes of the treatment strategy in the trial and resulted in similar study conclusions. Variations in results across approaches were mainly due to variations in estimated outcomes for the observational data. Conclusions: Five different approaches to handle longitudinal missing data resulted in similar conclusions in our example. However, the extent and complexity of missing observational data affected estimated comparative outcomes across approaches, highlighting the need for careful consideration of methods to account for missingness when using observational data as external controls to trial data.

Hospital accreditation systems and salience of organisational tensions

PurposeThis study examines how an externally imposed management control system (MCS) – hospital accreditation – influences the salience of organisational tensions and consequently attitudes of management towards the system.Design/methodology/approachData are collected using a case study of a large public hospital in Spain. In-depth interviews were conducted with 27 senior and middle managers across different functions. Relying on the organisational dualities classification in the literature, tensions are unpacked and analysed.FindingsEvidence is presented of how hospital accreditation increases the salience of organisational tensions arising from exposition of the organisational dualities of learning, performing, organising and belonging. Salient tensions were evident in the ambivalent attitudes of management towards the hospital accreditation system.Practical implicationsThe role of mandatory external control systems in exposing ambivalence and tensions will be of interest to organisational managers.Originality/valueThe study extends the management control literature by identifying an active role for an external MCS (accreditation) in increasing the salience of organisational tensions and triggering ambivalence. Contrary to the prior literature, the embedding of both poles of an organisational duality into the MCS is not a necessary precondition for increased tension salience. The range of attitudes towards MCSs beyond those specified in the previous literature (positive/negative/neutral) is extended to include ambivalence.

Peculiarities of purpose in providing the information stability of surveillance radar sensing modes in the process of their radio electronic suppression

It is possible to look at the special features of the goal setting while ensuring information stability of radar sounding modes when they are suppressed by the active interferences and interfering information influences. Overcoming the complexity of goal-setting processes, the validity and prompt decision-making with a shortage of time for its adoption is associated with insuring the consistency of goal-setting the levels of their intellectualization and formalization. This will contribute to imparting the desired properties, synthesized during the conflict, to the multipurpose strategies and the situational law of the control of the REP processes and the coordination of actions. An increase in the level of intellectualization of goal-setting processes is ensured by: decomposition of the general goal-setting problem into separate, simpler subtasks with effective solutions, implemented in the corresponding subsystems of the ACSstab (or basic associations of its functional elements) at stages of information support, preparation, adoption and implementation of the decision at the stages of hierarchical levels of management; cognitive analysis of goals and reflexive synthesis of goal-setting processes using the capabilities of a specialized intelligent decision support system to enhance the creative-reflexive abilities of the subject of management and increase the level of his professional competencies; combining the universality of the stages of rational management of the synthesis of the strategy for managing the REP processes with the specifics of conflict situations, subjectivity, cognition and reflexivity nature of intellectual control. Methods and means of partial formalization of goal-setting processes are presented, when the structuring of the main goal is carried out taking into account belonging to the strategies of internal and external control of the REP, the decomposition of the two-sided dynamic model of the conflict between the systems of the RES complex and the radar, the hierarchy of management levels, various approaches applied to goal-setting in a crisis management, as well as methods of justifying goals, resource costs and control of achieving the goals. These features can significantly reduce the degree of subjectivity of management for goal-setting and achieve their validity, completeness, consistency.

Improving the detection and reporting of suspicious financial transactions: the Spanish case

Purpose The purpose of this paper is to analyze the obligation of regulated entities to detect unusual and suspicious transactions and to report them to external control bodies, as established by the Financial Action Task Force (FATF) recommendations, the European Community Directive and also the Spanish regulations for the Prevention of Money Laundering. This research paper also aims to create a model to identify and report suspicious transactions to improve financial institutions’ current procedures. Design/methodology/approach According to the Spanish regulations which comply with the FATF recommendations and the European Community Directive on the Prevention of Money Laundering, regulated entities must detect unusual and suspicious transactions. Within this framework, the present research work analyzes both criteria and procedures used by the regulated entities to report suspicious operations. It also assesses the efficiency of the reports sent to an external control body. For this purpose, both analytical and interpretative methods are used in this research paper. Findings In Spain, the current procedures followed by regulated entities to analyze unusual transactions are complex. This results in difficulties to report suspicious transactions involving money laundering. As a consequence, the cases of suspicious transactions reported to the external control body are often unclear and the related process is inefficient. Originality/value The creation of a harmonized model with the aim of detecting suspicious operations and analyzing them will improve the detection and the effectiveness of the suspicious operations procedure which are reported to the external control body. However, such unified model should take into account the currently used activities proposed by each financial institution.

Modern Concept of Development of Audit Activity in Russia

The article discusses changes in the legislation of auditing in relation to the subject of the audit, preparation and signing of an audit report, regulation of audit activities, external control of the activities of audit organizations, auditors.