An evaluation of the minutes of subject expert committee meetings of novel COVID-19 proposals

SummaryAn international collaborative study involving ten laboratories located in eight different countries was undertaken in order to replace the current International Standard (I.S.) for tissue plasminogen activator (t-PA). Two lyophilised candidate preparations of high purity were assessed in comparison with the current I.S. for t-PA using only a clot lysis assay. One preparation (coded 861670) was purified from a cultured melanoma cell supernatant and was about 98% single chain t-PA while the other preparation (coded 861624) was derived from Chinese hamster ovary (CHO) cells following DNA recombinant procedures and was 75% single chain t-PA.Both candidate preparations of t-PA compared in quite a satisfactory manner with the current I.S. from the viewpoint of the biometrics of parallel line bioassays and both preparations were quite stable for long periods at low temperatures and stable from up to 1 month at temperatures of 20° and 38° C. Both fultil the criteria to serve as a satisfactory Znd International Standard for t-PA. The Fibrinolysis Subcommittee of the International Committee for Thrombosis and Haemostasis recommended the melanoma source t-PA (861670) as the next I.S. in order to maintain continuity with the 1st I.S. which was also a melanomatype preparation. The data from the ten laboratories indicated that each ampoule of the new proposed standard contains 850 international units of t-PA activity by the clot lysis assay. It is planned to present the results of this study to the Expert Committee on Biological Standardization of the World Health Organization at its next meeting and to request that the preparation of t-PA, coded 861670, be established as the 2ndlnternational Standard for t-PA.

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A Collaborative Study to Establish an International Standard for Alpha-Thrombin

Thrombosis and Haemostasis ◽

10.1055/s-0038-1648464 ◽

1992 ◽

Vol 67 (04) ◽

pp. 424-427 ◽

Cited By ~ 3

Author(s):

P J Gaffney ◽

A B Heath ◽

J W Fenton II

Keyword(s):

Elevated Temperatures ◽

Collaborative Study ◽

World Health Organisation ◽

Significant Loss ◽

Thrombin Inhibitors ◽

World Health ◽

Expert Committee ◽

International Standard ◽

Assay Procedure ◽

And Control

SummarySince 1975 an International Standard for Thrombin of low purity has been used. While this standard was stable and of value for calibrating thrombins of unknown potency the need for a pure a-thrombin standard arose both for accurate calibration and for precise measurement of thrombin inhibitors, notably hirudin. An international collaborative study was undertaken to establish the potency and stability of an ampouled pure a-thrombin preparation. A potency of 97.5 international units (95% confidence limits 86.5-98.5) was established for the new a-thrombin standard (89/ 588) using a clotting-assay procedure. Stability data at various elevated temperatures indicated that the standard could be transported and stored with no significant loss of potency.Ampoules of lyophilised a-thrombin (coded 89/588) have been recommended as an International Standard for a-thrombin with an assigned potency of 100 international units per ampoule by the International Society for Thrombosis and Haemostasis (Thrombin and its Inhibitors Sub-Committee) in Barcelona, Spain in July 1990 while the Expert Committee on Biological Standardisation and Control of the World Health Organisation will consider its status at its next meeting in Geneva in 1991.

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A Collaborative Study of a Proposed International Standard for Tissue Plasminogen Activator (t-PA)

Thrombosis and Haemostasis ◽

10.1055/s-0038-1661253 ◽

1985 ◽

Vol 53 (01) ◽

pp. 134-136 ◽

Cited By ~ 70

Author(s):

P J Gaffney ◽

A D Curtis

Keyword(s):

Plasminogen Activator ◽

Tissue Plasminogen Activator ◽

Collaborative Study ◽

International Committee ◽

World Health ◽

Clot Lysis ◽

Expert Committee ◽

International Standard ◽

Tissue Plasminogen ◽

Health Organization

SummaryAn international collaborative study involving seven laboratories was undertaken to assess which of three lyophilised preparations might serve as an International Standard (I.S.) for tissue plasminogen activator (t-PA). Two of the preparations were isolates from human melanoma cell cultures while one was of pig heart origin. A clot lysis assay was used by all participants in the study.The data suggested that both preparations of human cell origin were comparable, in that their log dose-response lines were parallel, while that of the porcine preparation was not. Accelerated degradation studies indicated that one melanoma extract (denoted 83/517) was more stable than the other and it was decided to recommend preparation 83/517 as the standard for t-PA. The International Committee for Thrombosis and Haemostasis (Stockholm 1983) has recommended the use of this material as a standard and it has been established by the Expert Committee on Biological Standardization of the World Health Organization as the International, Standard for tissue plasminogen activator, with an assigned potency of 1000 International Units per ampoule.

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Developing a K-CDA Implementation Guide for Applying Health Information Exchange Service in South Korea (Preprint)

10.2196/preprints.25485 ◽

2020 ◽

Author(s):

Sung Won Jung ◽

Sungchul Bae ◽

Donghyeong Seong ◽

Byoung-Kee Yi

Keyword(s):

Information Exchange ◽

Health Information Exchange ◽

Expert Committee ◽

Healthcare Information ◽

Entry Level ◽

Template Library ◽

Value Sets ◽

Definition Of ◽

Document Level ◽

Section Level

BACKGROUND Through several years of the healthcare information exchange based on the HIE project, some problems were found in the CDA documents generated. OBJECTIVE To fix some problems, we developed the K-CDA Implementation Guide (K means S. Korea) that conforms to the HL7 CDA, and suits the domestic conditions regarding the healthcare information. METHODS We achieved by analyzing HIE guideline and the U.S. C-CDA, and comparing each item. The items that required further discussion were reviewed by the expert committee. Based on the reviews, the previously developed templates were revised. RESULTS A total of 35 CDA templates were developed: five document-level templates, fourteen section-level templates, and sixteen entry-level templates. The 28 value sets used in the templates have been improved and the OIDs for HIE have been redefined CONCLUSIONS The K-CDA IG allows management in the form of a template library based on the definition of the General K-Header and the structured templates. This enables the K-CDA IG to respond to the expansion of national HIE templates with flexibility. For the K-CDA IG, the CDA template in current use was incorporated to the greatest extent possible, to minimize the scope of modifications. It enables the national HIE and the HIE with countries abroad.

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Standardisation of von Willebrand Factor in Therapeutic Concentrates: Calibration of the 1st International Standard for von Willebrand Factor Concentrate (00/514)

Thrombosis and Haemostasis ◽

10.1055/s-0037-1613226 ◽

2002 ◽

Vol 88 (09) ◽

pp. 380-386 ◽

Cited By ~ 9

Author(s):

Dawn Sands ◽

Andrew Chang ◽

Claudine Mazurier ◽

Anthony Hubbard

Keyword(s):

Von Willebrand Factor ◽

International Study ◽

Expert Committee ◽

International Standard ◽

A Value ◽

Significant Difference ◽

Factor Concentrate ◽

Von Willebrand ◽

Willebrand Factor ◽

Good Agreement

SummaryAn international study involving 26 laboratories assayed two candidate von Willebrand Factor (VWF) concentrates (B and C) for VWF:Antigen (VWF:Ag), VWF:Ristocetin Cofactor (VWF:RCo) and VWF:Collagen binding (VWF:CB) relative to the 4th International Standard Factor VIII/VWF Plasma (4th IS Plasma) (97/586). Estimates of VWF:Ag showed good agreement between different methods, for both candidates, and the overall combined means were 11.01 IU/ml with inter-laboratory variability (GCV) of 10.9% for candidate B and 14.01 IU/ml (GCV 11.8%) for candidate C. Estimates of VWF:RCo showed no significant difference between methods for both candidates and gave overall means of 9.38 IU/ml (GCV 23.7%) for candidate B and 10.19 IU/ml (GCV 24.4%) for candidate C. Prior to the calibration of the candidates for VWF:CB it was necessary to calibrate the 4th IS Plasma relative to local frozen normal plasma pools; there was good agreement between different collagen reagents and an overall mean of 0.83 IU per ampoule (GCV 11.8%) was assigned. In contrast, estimates of VWF:CB in both candidates showed large differences between collagen reagents with inter-laboratory GCV’s of 40%. Candidate B (00/514) was established as the 1st International Standard von Willebrand Factor Concentrate by the WHO Expert Committee on Biological Standardisation in November 2001 with assigned values for VWF:Ag (11.0 IU/ampoule) and VWF:RCo (9.4 IU/ampoule). Large inter-laboratory variability of estimates precluded the assignment of a value for VWF:CB.

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Development and Practical Application of a Multiple-Criteria Decision Analysis Framework on Respiratory Inhalers: Is It Always Useful in the MOH Malaysia Medicines Formulary Listing Context?

MDM Policy & Practice ◽

10.1177/2381468321994063 ◽

2021 ◽

Vol 6 (1) ◽

pp. 238146832199406

Author(s):

Yee Vern Yong ◽

Siti Hajar Mahamad Dom ◽

Nurulmaya Ahmad Sa’ad ◽

Rosliza Lajis ◽

Faridah Aryani Md. Yusof ◽

...

Keyword(s):

Decision Analysis ◽

Task Force ◽

Additive Model ◽

Multiple Criteria ◽

Multiple Criteria Decision Analysis ◽

Expert Committee ◽

Microsoft Excel ◽

Economic Criterion ◽

Published Evidence ◽

Framework Development

Objectives. The current health technology assessment used to evaluate respiratory inhalers is associated with limitations that have necessitated the development of an explicit formulary decision-making framework to ensure balance between the accessibility, value, and affordability of medicines. This study aimed to develop a multiple-criteria decision analysis (MCDA) framework, apply the framework to potential and currently listed respiratory inhalers in the Ministry of Health Medicines Formulary (MOHMF), and analyze the impacts of applying the outputs, from the perspective of listing and delisting medicines in the formulary. Methods. The overall methodology of the framework development adhered to the recommendations of the ISPOR MCDA Emerging Good Practices Task Force. The MCDA framework was developed using Microsoft Excel 2010 and involved all relevant stakeholders. The framework was then applied to 27 medicines, based on data gathered from the highest levels of available published evidence, pharmaceutical companies, and professional opinions. The performance scores were analyzed using the additive model. The end values were then deliberated by an expert committee. Results. A total of eight main criteria and seven subcriteria were determined by the stakeholders. The economic criterion was weighted at 30%. Among the noneconomic criteria, “patient suitability” was weighted the highest. Based on the MCDA outputs, the expert committee recommended one potential medicine (out of three; 33%) be added to the MOHMF and one existing medicine (out of 24; 4%) be removed/delisted from the MOHMF. The other existing medicines remained unchanged. Conclusions. Although this framework was useful for deciding to add new medicines to the formulary, it appears to be less functional and impactful for the removal/delisting existing medicines from the MOHMF. The generalizability of this conclusion to other formulations remains to be confirmed.

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Adaptation of the barriers to help-seeking for trauma (BHS-TR) scale: a cross-cultural cognitive interview study with female intimate partner violence survivors in Iceland

Journal of Patient-Reported Outcomes ◽

10.1186/s41687-021-00295-0 ◽

2021 ◽

Vol 5 (1) ◽

Author(s):

Karen Birna Thorvaldsdottir ◽

Sigridur Halldorsdottir ◽

Rhonda M. Johnson ◽

Sigrun Sigurdardottir ◽

Denise Saint Arnault

Keyword(s):

Intimate Partner Violence ◽

Partner Violence ◽

Help Seeking ◽

Cognitive Interview ◽

Intimate Partner ◽

Interview Study ◽

Trauma Survivors ◽

Expert Committee ◽

Health Related ◽

Trauma Informed

Abstract Background Even though traumatization is linked to substantially reduced health-related quality of life, help-seeking and service utilization among trauma survivors are very low. To date, there has not been available in Iceland a culturally attuned, self-reported measure on help-seeking barriers after trauma. This study aimed to translate and cross-culturally adapt the English version of Barriers to Help-Seeking for Trauma (BHS-TR) scale into the Icelandic language and context. Methods The BHS-TR was culturally adapted following well-established and rigorous guidelines, including forward-backward translation, expert committee review, and pretesting through cognitive interviews. Two rounds of interviews with 17 female survivors of intimate partner violence were conducted using a think-aloud technique and verbal probing. Data were analyzed using qualitative content analysis, a combination of deductive and inductive approaches. Results Issues with the BHS-TR that were uncovered in the study were classified into four categories related to general design, translation, cultural aspects, and post-trauma context. The trauma-specific issues emerged as a new category identified in this study and included concepts specific to trauma experiences. Therefore, modifications were of great importance—resulting in the scale becoming more trauma-informed. Revisions made to address identified issues improved the scale, and the process led to an Icelandic version, which appears to be semantically and conceptually equivalent to the original version; additionally, the results provided evidence of content validity. Conclusions As a cognitive interview study, it adds to the growing cognitive interviewing methodology literature. Furthermore, the results provide essential insights into the self-report response process of trauma survivors, highlighting the significance of making health-related research instruments trauma-informed.

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Scale of Assessment of Self-Care Behaviors with Arteriovenous Fistula in Hemodialysis: A Psychometric Study in Brazil

Clinical Nursing Research ◽

10.1177/1054773821989800 ◽

2021 ◽

pp. 105477382198980

Author(s):

Marta Nunes Lira ◽

Clemente Neves Sousa ◽

Maria Carolina Medeiros Wanderley ◽

Natália Ramos Costa Pessoa ◽

Kelly Cristiane Rocha Lemos ◽

...

Keyword(s):

Factor Analysis ◽

Psychometric Properties ◽

Arteriovenous Fistula ◽

Content Validity ◽

Self Care ◽

The Self ◽

Expert Committee ◽

Cronbach’S Alpha ◽

Cronbach's Alpha ◽

Confirmatory Factor

The purpose of this study was to evaluate the psychometric properties of the Brazilian Scale for the Assessment of Self-Care Behaviors with Arteriovenous Fistula in Hemodialysis. Cross-sectional validation study, followed the recommendation provided by Sousa and Rojjanasrirat. Content validity, explanatory and confirmatory factor analyses used to check validity and Cronbach’s alpha was the reliability measure. Three hundred hemodialysis patients with arteriovenous fistula were included in the study. The expert committee assessed the content validity. Exploratory factor analysis confirmed the same two-factor structure found for the original scale, explaining 60.10% of the variance. Such solution was checked by confirmatory factor analysis with Cronbach’s alpha equal to 0.920, 0.810, and 0.884 for the overall scale, the self-care in management of signs and symptoms and the self-care in prevention of complications subscales respectively. The scale has good psychometric properties to assess self-care behaviors and can be used with Brazilian patients on hemodialysis with arteriovenous fistula.

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