scholarly journals DEFINITION OF THE TARGET POPULATION FOR EXTERNAL PACEMAKER AS A KEY ASPECT IN SUCCESSFUL MEDICAL DEVICE HTA PROCESS

2020 ◽  
Vol 89 (2) ◽  
pp. 99-107
Author(s):  
Jan Honegr ◽  
Daniel Jun ◽  
Kamil Kuca ◽  
Petra Maresova
Keyword(s):  
Medical Device ◽  
Target Population ◽  
Definition Of

Study Population

2018 ◽  
pp. 45-67
Author(s):  
Sandra Carvalho ◽  
Felipe Fregni ◽  
Andre Brunoni
Keyword(s):  
Target Population ◽  
Study Phase ◽  
Snowball Sampling ◽  
Open Label ◽  
Post Marketing ◽  
Study Population ◽  
Multistage Sampling ◽  
Definition Of ◽  
Phase Ii And Iii ◽  
Internal And External Validity

Chapter 3 discusses the decision-making process of choosing the study population. This is critical given that any study’s main goal is to make inferences that go beyond the individuals under study and can be used to explain the phenomenon in the broader population with shared characteristics or conditions. In this chapter, the definition of the target population is discussed—i.e. the portion of the general population from which a researcher wants to draw robust conclusions or inferences. The sampling process according to the study phase is also summarized, focusing on phase II and III clinical trials, as phase I trials are especially designed to assess safety, while phase IV trials are open-label studies, usually assessing post-marketing safety. The internal and external validity of a study is also discussed, as well as sampling methods, both probabilistic (simple random, systematic, stratified, cluster, or multistage sampling) and non-probabilistic (convenience, consecutive, and snowball sampling).

Clinical Consensus Statement: Balloon Dilation of the Eustachian Tube

2019 ◽  
Vol 161 (1) ◽  
pp. 6-17 ◽  
Author(s):  
Debara L. Tucci ◽  
Edward D. McCoul ◽  
Richard M. Rosenfeld ◽  
David E. Tunkel ◽  
Pete S. Batra ◽  
...  
Keyword(s):  
Eustachian Tube ◽  
Delphi Method ◽  
Consensus Statement ◽  
Expert Panel ◽  
Balloon Dilation ◽  
Target Population ◽  
Functional Health ◽  
Modified Delphi ◽  
Tube Dysfunction ◽  
Definition Of

ObjectiveTo develop a clinical consensus statement on the use of balloon dilation of the eustachian tube (BDET).MethodsAn expert panel of otolaryngologists was assembled with nominated representatives of general otolaryngology and relevant subspecialty societies. The target population was adults 18 years or older who are candidates for BDET because of obstructive eustachian tube dysfunction (OETD) in 1 or both ears for 3 months or longer that significantly affects quality of life or functional health status. A modified Delphi method was used to distill expert opinion into clinical statements that met a standardized definition of consensus.ResultsAfter 3 iterative Delphi method surveys, 28 statements met the predefined criteria for consensus, while 28 statements did not. The clinical statements were grouped into 3 categories for the purposes of presentation and discussion: (1) patient criteria, (2) perioperative considerations, and (3) outcomes.ConclusionThis panel reached consensus on several statements that clarify diagnosis and perioperative management of OETD. Lack of consensus on other statements likely reflects knowledge gaps regarding the role of BDET in managing OETD. Expert panel consensus may provide helpful information for the otolaryngologist considering the use of BDET for the management of patients with OETD.

scholarly journals Insights into the definition of terms in European medical device regulation

2016 ◽  
Vol 13 (10) ◽  
pp. 907-917 ◽  
Author(s):  
Marco Racchi ◽  
Stefano Govoni ◽  
Adele Lucchelli ◽  
Laura Capone ◽  
Emiliano Giovagnoni
Keyword(s):  
Medical Device ◽  
Definition Of ◽  
Medical Device Regulation

La figura del biostatistico nei Comitati Etici (CE). Linee guida per il ruolo del biostatistico e per l’attività del biostatistico nella revisione dei protocolli degli studi proposti al parere dei CE

2016 ◽  
Vol 65 (5) ◽  
Author(s):  
Bruno Mario Cesana ◽  
Elio Mario Briganzoli
Keyword(s):  
Experimental Studies ◽  
Ethics Committees ◽  
Target Population ◽  
Statistical Analysis Plan ◽  
Point Of View ◽  
General Nature ◽  
Professional Recognition ◽  
Definition Of ◽  
Active Contribution

Gli autori considerano il ruolo del Biostatistico (BS) dei Comitati Etici (CE) per i farmaci in Italia e delineano le competenze che tale figura di professionista dovrebbe possedere unitamente alle problematiche che l’emissione del parere da parte del CE comporta dal punto di vista statistico. Oltre gli aspetti di natura generale, sono considerati gli specifici campi in cui la metodologia statistica deve applicarsi al fine di valutare la scientificità e la eticità degli studi sottoposti a parere al CE. In particolare, è considerato il riconoscimento professionale del BS del CE, il ruolo che il BS del CE ha nel considerare gli aspetti di sua precipua competenza dei protocolli sottoposti a parere sia per quanto riguarda gli studi sperimentali e, quindi, la randomizzazione, la definizione della popolazione obiettivo dell’analisi, l’individuazione degli endpoint, la rilevazione delle variabili, la formalizzazione delle ipotesi statistiche che portano al calcolo della dimensione campionaria. Inoltre, sono considerati gli aspetti relativi alla formulazione del piano dell’analisi statistica. Infine, una serie di tipologie di studi sperimentali ed osservazionali con i peculiari aspetti metodologici di natura statistica sono considerati unitamente agli avvertimenti da dare al BS del CE per portare il suo fattivo contributo alla valutazione ed alla loro discussione nel contesto del CE.The authors consider the role of the Biostatistician of the Ethics Committees (EC) for Drugs in Italy and outlines the skills that this professional figure should possess together with the problems that the issuance of a judgment by the EC acts from the point of view statistical. Besides the aspects of a general nature, the authors regarded the specific fields in which the statistical methodology must be applied in order to approve the scientific and ethical nature of the studies submitted to the EC opinion. Particularly, it is considered the professional recognition of the Biostatistician of the EC, and his/her role in the context of the EC in considering the aspects of his/her primary field of knowledge regarding the protocols submitted to the CE. The different aspects regard the experimental studies and, therefore, the randomization, the definition of the target population, the identification of the endpoints, the detection of the variables, the formalization of the statistical assumptions that lead to the calculation of sample size. Finally, the aspects relating to the development of the statistical analysis plan are taken into account. Finally, several experimental and observational studies with their specific methodological statistical aspects are considered together with the warnings to be given to the Biostatistician of the EC to bring his/her active contribution to the evaluation and the discussion in the context of the EC section.

scholarly journals Developing HL7 CDA-Based Data Warehouse for the Use of Electronic Health Record Data for Secondary Purposes

ACI Open ◽  
2019 ◽  
Vol 03 (01) ◽  
pp. e44-e62
Author(s):  
Fabrizio Pecoraro ◽  
Daniela Luzi ◽  
Fabrizio L. Ricci
Keyword(s):  
Conceptual Framework ◽  
Data Warehouse ◽  
Large Scale ◽  
Heterogeneous Systems ◽  
Target Population ◽  
Electronic Health Record Data ◽  
Health Level 7 ◽  
Electronic Health ◽  
Unique Source ◽  
Definition Of

Background The growing availability of clinical and administrative data collected in electronic health records (EHRs) have led researchers and policy makers to implement data warehouses to improve the reuse of EHR data for secondary purposes. This approach can take advantages from a unique source of information that collects data from providers across multiple organizations. Moreover, the development of a data warehouse benefits from the standards adopted to exchange data provided by heterogeneous systems. Objective This article aims to design and implement a conceptual framework that semiautomatically extracts information collected in Health Level 7 Clinical Document Architecture (CDA) documents stored in an EHR and transforms them to be loaded in a target data warehouse. Results The solution adopted in this article supports the integration of the EHR as an operational data store in a data warehouse infrastructure. Moreover, data structure of EHR clinical documents and the data warehouse modeling schemas are analyzed to define a semiautomatic framework that maps the primitives of the CDA with the concepts of the dimensional model. The case study successfully tests this approach. Conclusion The proposed solution guarantees data quality using structured documents already integrated in a large-scale infrastructure, with a timely updated information flow. It ensures data integrity and consistency and has the advantage to be based on a sample size that covers a broad target population. Moreover, the use of CDAs simplifies the definition of extract, transform, and load tools through the adoption of a conceptual framework that load the information stored in the CDA in the data warehouse.

Accomplishing Team: Teamwork and Categorisation in Two Community Mental Health Teams

1997 ◽  
Vol 45 (1) ◽  
pp. 59-78 ◽  
Author(s):  
Lesley Griffiths
Keyword(s):  
Mental Health ◽  
Mental Illness ◽  
Community Mental Health ◽  
Serious Mental Illness ◽  
Target Population ◽  
The Other ◽  
Team Meetings ◽  
The Social ◽  
Inclusive Approach ◽  
Definition Of

This paper describes the social organisation of two newly-formed community mental health teams, examining their differing relationship with team psychiatrists and the resulting constitution of team activities. Different ways of accomplishing ‘team’ had consequences for the ways mental illness was categorised and the target population for services was framed. The attendance or non-attendance of psychiatrists at team meetings, and the framing of meetings as ‘allocation’ or ‘review’, critically affected the nature of teamwork. One team took advantage of the absence of the psychiatrist to resist the bureaucratic framing of its task as ‘allocation’, and gained some autonomy by delaying acceptance of ‘inappropriate’ patients onto caseloads. The second team met regularly with its psychiatrist and was allowed a voice in the ‘review’ of cases, but discussions and decisions fell largely under the control of the dominant professional. Transcripts of team meetings are analyzed to show how the two teams develop divergent discursive repertoires, which are then deployed in the categorisation of patients. The team who meet without the psychiatrist attempt to control their workload by developing a relatively exclusionary definition of serious mental illness which excludes the ‘worried well’, while the other team take a more inclusive approach.

scholarly journals Definition of Information Technology Architectures for Continuous Data Management and Medical Device Integration in Diabetes

2008 ◽  
Vol 2 (5) ◽  
pp. 899-905 ◽  
Author(s):  
M. Elena Hernando ◽  
Mario Pascual ◽  
Carlos H. Salvador ◽  
Gema García-Sáez ◽  
Agustín Rodríguez-Herrero ◽  
...  
Keyword(s):  
Information Technology ◽  
Data Management ◽  
Medical Device ◽  
Continuous Data ◽  
Device Integration ◽  
Definition Of ◽  
Definition Of Information

LOOKING BACK ON 5 YEARS OF HORIZON SCANNING IN ONCOLOGY

2016 ◽  
Vol 32 (1-2) ◽  
pp. 54-60 ◽  
Author(s):  
Anna Nachtnebel ◽  
Johanna Breuer ◽  
Wolfgang Willenbacher ◽  
Anna Bucsics ◽  
Peter Krippl ◽  
...  
Keyword(s):  
Environmental Analysis ◽  
User Satisfaction ◽  
Expert Panel ◽  
Target Population ◽  
Dissemination Strategy ◽  
Horizon Scanning ◽  
Definition Of ◽  
High Level ◽  
The Impact ◽  
Collaborative Efforts

Objectives: The regularly structured adaptation of health technology assessment (HTA) programs is of utmost importance to sustain the relevance of the products for stakeholders and to justify investment of scarce financial resources. This study describes internal adjustments and external measures taken to ensure the Horizon Scanning Programme in Oncology (HSO) is current.Methods: Formal evaluation methods comprising a survey, a download, an environmental analysis, and a Web site questionnaire were used to evaluate user satisfaction.Results: The evaluation showed that users were satisfied with HSO outputs in terms of timeliness, topics selected, and depth of information provided. Discussion of these findings with an expert panel led to changes such as an improved dissemination strategy and the introduction of an additional output, that is, the publication of a league table of emerging oncology drugs. The rather high level of international usage and the environmental analysis highlighted a considerable overlap in topics assessed and, thus, the potential for international collaboration. As a consequence, thirteen reports were jointly published based on eleven “calls for collaboration.” To further facilitate collaboration and the usability of reports for other agencies, HSO reports will be adjusted according to tools developed at a European level.Conclusions: Evaluation of the impact of HTA programs allows the tailoring of outputs to fit the needs of the target population. However, within a fast developing HTA community, estimates of impact will increasingly be determined by international collaborative efforts. Refined methods and a broader definition of impact are needed to ultimately capture the efficiency of national HTA programs.

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