scholarly journals Pilot test of an accrual Common Metric for the NIH Clinical and Translational Science Awards (CTSA) Consortium: Metric feasibility and data quality

Author(s):  
Denise H. Daudelin ◽  
Laura E. Peterson ◽  
Harry P. Selker

Abstract Failure to accrue participants into clinical trials incurs economic costs, wastes resources, jeopardizes answering research questions meaningfully, and delays translating research discoveries into improved health. This paper reports the results of a pilot test of the Median Accrual Ratio (MAR) metric developed as a part of the Common Metrics Initiative of the NIH’s National Center for Advancing Translational Science (NCATS) Clinical and Translational Science Award (CTSA) Consortium. Using the metric is intended to enhance the ability of the CTSA Consortium and its “hubs” to increase subject accrual into trials within expected timeframes. The pilot test was undertaken at Tufts Clinical and Translational Science Institute (CTSI) with eight CTSA Consortium hubs. We describe the pilot test methods, and results regarding feasibility of collecting metric data and the quality of data that was collected. Participating hubs welcomed the opportunity to assess accrual efforts, but experienced challenges in collecting accrual metric data due to insufficient infrastructure and inconsistent implementation of electronic data systems and lack of uniform data definitions. Also, the metric could not be constructed for all trial designs, particularly those using competitive enrollment strategies. We offer recommendations to address the identified challenges to facilitate progress to broad accrual metric data collection and use.

Author(s):  
Laura E. Peterson ◽  
Denise H. Daudelin ◽  
Lisa C. Welch ◽  
Anshu Parajulee ◽  
Harry P. Selker

Abstract The Common Metrics Initiative aims to develop and field metrics to improve research processes within the national Clinical and Translational Science Award (CTSA) Consortium. A Median Accrual Ratio (MAR) common metric was developed to assess the results of efforts to increase subject accrual into a set of clinical trials within the expected time period. A pilot test of the MAR was undertaken at Tufts Clinical and Translational Science Institute (CTSI) with eight CTSA Consortium hubs. Post-pilot interviews were conducted with 9 CTSA Principal Investigators (PIs) and 23 pilot team members. Over three-quarters (78%) of respondents reported that the MAR could be useful for performance improvement, but also described limitations or concerns. The most commonly cited barrier to MAR use for performance improvement was difficulty in interpreting the single value that is produced. Most respondents were interested in using the MAR to assess recruitment at an individual trial level. Majority of respondents (63%) had mixed opinions about aggregating metric results across the CTSA Consortium for comparison or benchmarking. Collecting data about additional contextual factors, and comparing accrual between subgroups, were cited as potentially helping address concerns about aggregation. Significant challenges remain in ensuring that the MAR can be sufficiently useful for collaborative process improvement. We offer recommendations to potentially improve metric usefulness.


Author(s):  
Milagros Castillo-Montoya

This article presents the interview protocol refinement (IPR) framework comprised of a four-phase process for systematically developing and refining an interview protocol. The four-phase process includes: (1) ensuring interview questions align with research questions, (2) constructing an inquiry-based conversation, (3) receiving feedback on interview protocols, and (4) piloting the interview protocol. The IRP method can support efforts to strengthen the reliability of interview protocols used for qualitative research and thereby contribute to improving the quality of data obtained from research interviews.


Author(s):  
B. L. Armbruster ◽  
B. Kraus ◽  
M. Pan

One goal in electron microscopy of biological specimens is to improve the quality of data to equal the resolution capabilities of modem transmission electron microscopes. Radiation damage and beam- induced movement caused by charging of the sample, low image contrast at high resolution, and sensitivity to external vibration and drift in side entry specimen holders limit the effective resolution one can achieve. Several methods have been developed to address these limitations: cryomethods are widely employed to preserve and stabilize specimens against some of the adverse effects of the vacuum and electron beam irradiation, spot-scan imaging reduces charging and associated beam-induced movement, and energy-filtered imaging removes the “fog” caused by inelastic scattering of electrons which is particularly pronounced in thick specimens.Although most cryoholders can easily achieve a 3.4Å resolution specification, information perpendicular to the goniometer axis may be degraded due to vibration. Absolute drift after mechanical and thermal equilibration as well as drift after movement of a holder may cause loss of resolution in any direction.


2018 ◽  
Vol 13 (Number 2) ◽  
pp. 67-77
Author(s):  
Anis Syamimi Abd Rahim ◽  
Mohd Norhasni Mohd Asaad

The purpose of this study is to review the implementation of ISO 9001:2015 in order to improve the quality of services at Pusat Kesihatan Universiti (PKU), Universiti Utara Malaysia. The respondents of this study were customers at the PKU, UUM. The questionnaire was distributed to 50 respondents. The data were analyzed using SPSS software version 24. The data were tested using descriptive statistics, and correlation analysis to answer the research questions and to achieve the objectives. The findings show that customers agree that implementation of ISO 9001:2015 give service at PKU, UUM is good and satisfied. Through the correlation test, the results showed that the relationship between the implementation of ISO 9001:2015 has a positive and significant impact on customer satisfaction and the effect of implementing ISO 9001:2015 has a positive and significant impact in improving quality of service at PKU, UUM.Through mean and standard deviation tests, results show that tangible dimensions are the main dimensions of customer satisfaction while dimensions with low values are dimensions of responsiveness.Therefore, all aspects of service in PKU, UUM will be strengthened and all aspects of the weaknesses could be addressed to improve the service in order to maintain good quality services.


2020 ◽  
Vol 26 (11) ◽  
pp. 2567-2593
Author(s):  
M.V. Pomazanov

Subject. The study addresses the improvement of risk management efficiency and the quality of lending decisions made by banks. Objectives. The aim is to present the bank management with a fair algorithm for risk management motivation on the one hand, and the credit management (business) on the other hand. Within the framework of the common goal to maximize risk-adjusted income from loans, this algorithm will provide guidelines for ‘risk management’ and ‘business’ functions on how to improve individual and overall efficiency. Methods. The study employs the discriminant analysis, type I and II errors, Lorentz curve modeling, statistical analysis, economic modeling. Results. The paper offers a mechanism for assessing the quality of risk management decisions as opposed to (or in support of) decisions of the lending business when approving transactions. The mechanism rests on the approach of stating type I and II errors and the corresponding classical metric of the Gini coefficient. On the ‘business’ side, the mechanism monitors the improvement or deterioration of the indicator of changes in losses in comparison with the market average. Conclusions. The study substantiates the stimulating ‘rules of the game’ between the ‘business’ and ‘risk management’ to improve the efficiency of the entire business, to optimize interactions within the framework of internal competition. It presents mathematical tools to calculate corresponding indicators of the efficiency of internally competing entities.


Author(s):  
Nur Maimun ◽  
Jihan Natassa ◽  
Wen Via Trisna ◽  
Yeye Supriatin

The accuracy in administering the diagnosis code was the important matter for medical recorder, quality of data was the most important thing for health information management of medical recorder. This study aims to know the coder competency for accuracy and precision of using ICD 10 at X Hospital in Pekanbaru. This study was a qualitative method with case study implementation from five informan. The result show that medical personnel (doctor) have never received a training about coding, doctors writing that hard and difficult to read, failure for making diagnoses code or procedures, doctor used an usual abbreviations that are not standard, theres still an officer who are not understand about the nomenclature and mastering anatomy phatology, facilities and infrastructure were supported for accuracy and precision of the existing code. The errors of coding always happen because there is a human error. The accuracy and precision in coding very influence against the cost of INA CBGs, medical and the committee did most of the work in the case of severity level III, while medical record had a role in monitoring or evaluation of coding implementation. If there are resumes that is not clearly case mix team check file needed medical record the result the diagnoses or coding for conformity. Keywords: coder competency, accuracy and precision of coding, ICD 10


2017 ◽  
Vol 4 (1) ◽  
pp. 25-31 ◽  
Author(s):  
Diana Effendi

Information Product Approach (IP Approach) is an information management approach. It can be used to manage product information and data quality analysis. IP-Map can be used by organizations to facilitate the management of knowledge in collecting, storing, maintaining, and using the data in an organized. The  process of data management of academic activities in X University has not yet used the IP approach. X University has not given attention to the management of information quality of its. During this time X University just concern to system applications used to support the automation of data management in the process of academic activities. IP-Map that made in this paper can be used as a basis for analyzing the quality of data and information. By the IP-MAP, X University is expected to know which parts of the process that need improvement in the quality of data and information management.   Index term: IP Approach, IP-Map, information quality, data quality. REFERENCES[1] H. Zhu, S. Madnick, Y. Lee, and R. Wang, “Data and Information Quality Research: Its Evolution and Future,” Working Paper, MIT, USA, 2012.[2] Lee, Yang W; at al, Journey To Data Quality, MIT Press: Cambridge, 2006.[3] L. Al-Hakim, Information Quality Management: Theory and Applications. Idea Group Inc (IGI), 2007.[4] “Access : A semiotic information quality framework: development and comparative analysis : Journal ofInformation Technology.” [Online]. Available: http://www.palgravejournals.com/jit/journal/v20/n2/full/2000038a.html. [Accessed: 18-Sep-2015].[5] Effendi, Diana, Pengukuran Dan Perbaikan Kualitas Data Dan Informasi Di Perguruan Tinggi MenggunakanCALDEA Dan EVAMECAL (Studi Kasus X University), Proceeding Seminar Nasional RESASTEK, 2012, pp.TIG.1-TI-G.6.


2019 ◽  
Author(s):  
Bogdan Corneliu Andor ◽  
Dionisio Franco Barattini ◽  
Dumitru Emanuel Dogaru ◽  
Simone Guadagna ◽  
Serban Rosu

BACKGROUND Osteoarthritis (OA) is one of the top five most disabling conditions and it affects more than one third of persons over 65 years of age. Currently 80% of persons affected by OA already report having some movement limitation, 20% of people are not be able to perform major activities of daily living, and about 11% of the total affected population need of personal care. On 2014 the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO) suggested as first step of pharmacological treatment for knee OA a background therapy with chronic symptomatic slow-acting drugs for osteoarthritis (SYSADOAs), such as glucosamine sulphate, chondroitin sulphate and hyaluronic acid (HA). In studies with oral HA, symptoms of OA are often measured using subjective parameters such as the visual analog scale (VAS) or the quality of life questionnaire (QoL) and objective measurements as ultrasonography (US) or range of motion (ROM) are employed in very few trials. This affects the quality of data in the literature. OBJECTIVE The primary objective of this work is to assess the feasibility of implementing US and ROM as objective measurements to correlate the improvement of knee mobility with pain reduction, evaluated using a subjective scale (VAS) in patients assuming a nutraceutical containing HA. The secondary objective is to evaluate the enrollment rate in one month to verify the feasibility for time and budget of the planned future main study. The explorative objective of the trial is to obtain preliminary data on efficacy of the tested product. METHODS This open-label pilot trial is performed in an orthopedic clinic (Timisoara, Romania). Male and female subjects (from 50 to 70 years) diagnosed with symptomatic OA of the knee with mild joint discomfort for at least 6 months are included. Following protocol, 8 patients are administered for 8 weeks Syalox® 300 Plus (River Pharma, Italy), a product based on HA of high molecular weight. Baseline and final visit assessments include orthopedic assessment, US, Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire, VAS and ROM of knee. RESULTS Data collection occurred between February 2018 and June 2018. All results are expected to be available by the end of 2018. CONCLUSIONS This pilot trial will be the first study to analyze the potential correlation between subjective evaluation (VAS, KOOS questionnaire) and objective measurements (US, ROM and actigraphy). The data from this study will assess the feasibility of the planned monthly recruitment rate and the necessary time and budget, and should provide preliminary information on efficacy of the tested product. CLINICALTRIAL ClinicalTrials.gov (NCT number: NCT03421054).


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