Purpose -The purpose of this paper is to apply interpretive structural modelling in the clarification of the perceptions of different individuals in a managerial group in order to improve group decision making. To limit conflict and increase shared knowledge in group decision making, there is a need to explain differences among group members at the cognitive level. Design/methodology/approach -Qualitative research has suggested methods that involve personal narratives and in-depth interviews. The effectiveness of such methods can be enhanced using the techniques of formal logic. The approach used for the case is a simulation of a strategic group decision-making process using interpretive structural modelling. The simulation contemplates a typical business scenario. It was done using role-play in strategic corporate problem solving: four functional managerial roles and one general managerial role were assigned. Individual and group relationships were portrayed. Findings -After analysing the results the authors found major differences in priority orderings of the different roles. As there are differences in the perception of the priority of the issues in the different managerial roles, it would be more difficult to take a decision. Research limitations/implications -The limitations of this research are that it was done with assigned roles instead of real executives. Further research could provide ways of identifying schools of thought in decision-making groups for strategic issues. Practical implications -The practical application of this paper would be in the hypothetical decision-making arena, improving the decision-making process among executives working in different functional areas. Originality/value -The application of formal logic methods to a decision-making process is the prime contribution of this paper.
The assessment about the proarrhythmic risk associated with a particular drug is a major requirement for drugs under development, since many drugs have been withdrawn from market or got under strict pharmacological vigilance because of such a risk. Predicting the development of a life-threatening arrhythmia is a hard task but, in the case of TdP ("Torsades de Pointes"), there are some useful markers. Among them, the prolongation of the QT interval and its heart rate correction (QTc) are the most remarkable. Actually, QT prolongation is considered the surrogate marker of TdP from the clinical and regulatory standpoint. ICH E14 provides recommendations to sponsors concerning the design, conduct, analysis, and interpretation of clinical studies to assess the potential of a drug to delay cardiac repolarization. The regulatory information about preclinical safety evaluation is contained in ICH S7B. Both guidelines have been a matter of intense debate. False negative and false positive results have been found within the preclinical and clinical field. There still are grey areas in which further research would be necessary. Improvement of tools that may contribute to complement the data from the human ether-a-go-go-related gene HERG channel and QT/QTc studies, such as concentration-QT relationship (CQT) studies and other innovative techniques, will be more than welcome.
Background Postoperative acute kidney injury (AKI) is a common complication of major gastrointestinal surgery with an impact on short- and long-term survival. No validated system for risk stratification exists for this patient group. This study aimed to validate externally a prognostic model for AKI after major gastrointestinal surgery in two multicentre cohort studies. Methods The Outcomes After Kidney injury in Surgery (OAKS) prognostic model was developed to predict risk of AKI in the 7 days after surgery using six routine datapoints (age, sex, ASA grade, preoperative estimated glomerular filtration rate, planned open surgery and preoperative use of either an angiotensin-converting enzyme inhibitor or an angiotensin receptor blocker). Validation was performed within two independent cohorts: a prospective multicentre, international study (‘IMAGINE’) of patients undergoing elective colorectal surgery (2018); and a retrospective regional cohort study (‘Tayside’) in major abdominal surgery (2011–2015). Multivariable logistic regression was used to predict risk of AKI, with multiple imputation used to account for data missing at random. Prognostic accuracy was assessed for patients at high risk (greater than 20 per cent) of postoperative AKI. Results In the validation cohorts, 12.9 per cent of patients (661 of 5106) in IMAGINE and 14.7 per cent (106 of 719 patients) in Tayside developed 7-day postoperative AKI. Using the OAKS model, 558 patients (9.6 per cent) were classified as high risk. Less than 10 per cent of patients classified as low-risk developed AKI in either cohort (negative predictive value greater than 0.9). Upon external validation, the OAKS model retained an area under the receiver operating characteristic (AUC) curve of range 0.655–0.681 (Tayside 95 per cent c.i. 0.596 to 0.714; IMAGINE 95 per cent c.i. 0.659 to 0.703), sensitivity values range 0.323–0.352 (IMAGINE 95 per cent c.i. 0.281 to 0.368; Tayside 95 per cent c.i. 0.253 to 0.461), and specificity range 0.881–0.890 (Tayside 95 per cent c.i. 0.853 to 0.905; IMAGINE 95 per cent c.i. 0.881 to 0.899). Conclusion The OAKS prognostic model can identify patients who are not at high risk of postoperative AKI after gastrointestinal surgery with high specificity. Presented to Association of Surgeons in Training (ASiT) International Conference 2018 (Edinburgh, UK), European Society of Coloproctology (ESCP) International Conference 2018 (Nice, France), SARS (Society of Academic and Research Surgery) 2020 (Virtual, UK).
EditorialRandomized clinical trial is often considered as the Gold Standard method for comparing treatment effects. In practice, taking into consideration their main objectives, the majority of clinical trials are aimed to establish the superiority of an intervention regarding to an active control or placebo [1]. Within the methodological core of these so called superiority trials, the assessment of the statistical signification of the differences between or among interventions, and their clinical relevance, are both of main importance. Appropriate statistical tests to assess this superiority should be performed, with the null hypothesis being: the difference between treatments is equal to 0 (H0 = 0), and the alternative hypothesis: treatments are different -or, the difference between treatments is not equal to 0 (H1 0)(if two sided)-. The rejection of the null hypothesis is in the foundation of the methodological assessment of superiority [2]. The number of patients required to confront the hypotheses is inversely related to the expected between-treatment differences. The smallest the expected difference between two interventions, the highest the number of patients to be included into the trial. But, how to interpret a non-significant result obtained from a clinical study designed as a superiority trial? Does this mean that the interventions under study should be considered as equivalent?. Clearly, the answer is negative. From the methodological standpoint, the expression: we have no evidence of difference between treatments, should not be considered as equivalent to: we have evidence of no difference between interventions [3].Very often, the aim of a clinical trial is to show that a certain intervention is equivalent to or non inferior than another one. In this case, as stated before, a non-significant superiority testing should not be interpreted as a proof of no difference between treatments. Under an equivalence hypothesis, where the between treatments difference is assumed to be equal to 0, the calculation of a sample size following the rules established for superiority trials is impossible or in the best case (by employing an estimated difference close to 0) would result in an unrealistic extremely large number [1]. Instead, equivalence and non-inferiority trials should be conceived, planned and applied to these purposes. In general, neither equivalence nor non-inferiority should be definitively concluded from superiority trials exhibiting non-significant results.Improvements into the galenics of a formulation or a modification in a drug delivery system should not affect the pharmacokinetic (PK) profile of the drug. That is also the case for the comparison between the PK parameters of a generic preparation versus an original product. This is the rationale for the so called bioequivalence trials, the most frequent type of equivalence study. Being μ S the mean value for an specific PK indicator in the standard or the original product, and μ T the mean for the same parameter of the new product under testing,...
Background For 3 centuries Argentina was a Spanish colony and no local training in pharmacology was available until the creation of the Protomedicato school in 1799. After independence (1816), medical studies were transferred to the new University of Buenos Aires, created in 1821. By then, training followed the Spanish standard and Materia Medica included a lot of traditional therapeutic procedures. By1900, a different perspective was easily detectable, with strong influence of European scientists. The aim of this research is to characterize that shift and the more modern emphasis on clinical pharmacology. Methods We searched textbooks, papers and thesis filed at the library of the schools of medicine, dentistry, pharmacy and veterinary medicine of the University of Buenos Aires, at the National Academy of Medicine and the Argentine Medical Association. Results Until the end of the XXth century, 16 full professors of pharmacology (initially, Materia Medica) teached pharmacology at our school. Prolonged periods allowed long-lasting personal imprint of some professors,
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