scholarly journals Compliance of clinical trial registries with the World Health Organization minimum data set: a survey

Trials ◽  
2009 ◽  
Vol 10 (1) ◽  
Author(s):  
Lorenzo P Moja ◽  
Ivan Moschetti ◽  
Munira Nurbhai ◽  
Anna Compagnoni ◽  
Alessandro Liberati ◽  
...  
2017 ◽  
Vol 7 (1) ◽  
Author(s):  
Tabassom Baghai

An ongoing challenge in clinical research is the inaccessibility of clinical trial data, which prevents physicians from making an informed decision with regards to patient care. The U.S. Food and Drug Administration (FDA) as well as the World Health Organization (WHO) recently called for all trial data to be registered and made publically available. However, this issue is still ongoing and there are several measures currently being enforced to rectify these concerns. Potential solutions, such as regulations, campaigns, and possible conse- quences, for increasing transparency in clinical trial data will be discussed. RÉSUMÉ L’inaccessibilité des données provenant d’essais cliniques constitue un défi constant en recherche clinique, puisqu’elle empêche les médecins de prendre des décisions éclairées quant aux soins de leurs patients. Récemment, le Secrétariat américain aux produits alimentaires et pharmaceutiques (FDA) ainsi que l’Organisation mondiale de la Santé (OMS) ont demandé que toutes les données d’essais cliniques soient enregistrées et mises à la disposition du public. Toutefois, ce problème persiste et plusieurs mesures ont été mises en place pour répondre à ces préoccupations. Des solutions possibles dont des réglementations, des campagnes et des sanctions possibles pour améliorer la transparence en ce qui concerne les données d’essais cliniques seront discutées. 


2018 ◽  
Vol 6 ◽  
pp. 205031211879239 ◽  
Author(s):  
Jeff Kirk Svane ◽  
Ingrid Egerod ◽  
Hanne Tønnesen

Objectives: Health promotion is on the global agenda. The risks targeted include smoking, hazardous alcohol consumption, nutrition and insufficient physical activity. Implementation of clinical health promotion, however, remains a major challenge. While several processes, models and frameworks for strategic implementation exist, very few have been tested in randomized designs. Testing a strategic implementation process for clinical health promotion was only recently attempted via a randomized clinical trial on the World Health Organization Health Promotion Hospitals Recognition Process. The randomized clinical trial showed that the process improved central parts of implementation. To complement these findings, this nested qualitative study aimed to explore experiences and perceptions of staff and managers, who had completed the process, and generate hypotheses for improvements. Methods: We interviewed a purposeful sample of 45 key informants from four countries, who worked at clinical departments and had undertaken the World Health Organization Health Promotion Hospitals implementation process. The informants included 14 managers, 14 medical doctors, 13 nurses and 4 other clinical staff. Interview transcripts were analyzed using qualitative content analysis and an inductive approach to coding and categorization supported by QSR NVivo. Results: The informants’ experiences and perceptions centered around four global themes concerning (1) awareness, cultural re-orientation and integration; (2) learnings; (3) normalization and legitimacy and (4) a more evidence-based, structured and systematic approach to clinical health promotion. Informants were positive toward the implementation process, although it was sometimes challenging. The suggested improvements to increase acceptability related to the patient survey, time consumption, translation, tailoring to local circumstances and in-advance training. Conclusions: Managers and staff were positive toward the World Health Organization Health Promotion Hospitals process, which was perceived to bring about positive changes and learnings. The findings also suggest that the implementation process may be improved by minor adjustments to process elements and design. It is our recommendation to use the process in clinical departments to further implementation of clinical health promotion.


2021 ◽  
Vol 49 (1) ◽  
Author(s):  
J. Austin Lee ◽  
Kexin Qu ◽  
Monique Gainey ◽  
Samika S. Kanekar ◽  
Meagan A. Barry ◽  
...  

Abstract Background Episodes of acute diarrhea lead to dehydration, and existing care algorithms base treatment around categorical estimates for fluid resuscitation. This study aims to develop models for the percentage dehydration (fluid deficit) in individuals with acute diarrhea, to better target treatment and avoid the potential sequelae of over or under resuscitation. Methods This study utilizes data from two prospective cohort studies of patients with acute diarrhea in Dhaka, Bangladesh. Data were collected on patient arrival, including weight, clinical signs and symptoms, and demographic information. Consecutive weights were obtained to determine the true volume deficit of each patient. Data were entered into two distinct forward stepwise regression logistic models (DHAKA for under 5 years and NIRUDAK for 5 years and over). Results A total of 782 patients were included in the final analysis of the DHAKA data set, and 2139 were included in the final analysis of the NIRUDAK data set. The best model for the DHAKA data achieved an R2 of 0.27 and a root mean square error (RMSE) of 3.7 (compared to R2 of 0.06 and RMSE of 5.5 with the World Health Organization child care algorithm) and selected 6 predictors. The best performance model for the NIRUDAK data achieved an R2 of 0.28 and a RMSE of 2.6 (compared to R2 of 0.08 and RMSE of 4.3 with the World Health Organization adolescent/adult care algorithm) and selected 7 predictors with 2 interactions. Conclusions These are the first mathematical models for patients with acute diarrhea that allow for the calculation of a patient’s percentage dehydration (fluid deficit) and subsequent targeted treatment with fluid resuscitation. These findings are an improvement on existing World Health Organization care algorithms.


2017 ◽  
Vol 79 (07) ◽  
pp. 526-527

Coenen M et al. [Recommendation for the collection and analysis of data on participation and disability from the perspective of the World Health Organization]. Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz 2016; 59: 1060–1067 Um eine gleichberechtigte Teilhabe an der Gesellschaft von Menschen mit Behinderung zu ermöglichen, werden zunächst Daten zu vorhandenen Einschränkungen gebraucht. Erst wenn diese detailliert erhoben wurden, können Konzepte zur Beseitigung von Problemen entwickelt werden. Ein standardisiertes Erhebungsinstrument für alle Aspekte der Funktionsfähigkeit fehlte jedoch bisher.


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