scholarly journals International Council for Standardization in Haematology Recommendations for Hemostasis Critical Values, Tests, and Reporting

2019 ◽  
Vol 46 (04) ◽  
pp. 398-409 ◽  
Author(s):  
Robert C. Gosselin ◽  
Dorothy Adcock ◽  
Akbar Dorgalaleh ◽  
Emmanuel J. Favaloro ◽  
Giuseppe Lippi ◽  
...  
Keyword(s):  
Ad Hoc ◽  
Test List ◽  
Published Data ◽  
Guidance Document ◽  
International Council ◽  
Hospital Managers ◽  
Coagulation Tests ◽  
Good Laboratory ◽  
Guidance Documents ◽  
Institutional Stakeholders

AbstractThis guidance document was prepared on behalf of the International Council for Standardization in Haematology (ICSH), the aim of which is to provide hemostasis-related guidance documents for clinical laboratories. The current ICSH document was developed by an ad hoc committee, comprising an international collection of both clinical and laboratory experts. The purpose of this ICSH document is to provide laboratory guidance for (1) identifying hemostasis (coagulation) tests that have potential patient risk based on analysis, test result, and patient presentations, (2) critical result thresholds, (3) acceptable reporting and documenting mechanisms, and (4) developing laboratory policies. The basis for these recommendations was derived from published data, expert opinion, and good laboratory practice. The committee realizes that regional and local regulations, institutional stakeholders (e.g., physicians, laboratory personnel, hospital managers), and patient types (e.g., adults, pediatric, surgical) will be additional confounders for a given laboratory in generating a critical test list, critical value thresholds, and policy. Nevertheless, we expect this guidance document will be helpful as a framework for local practice.

scholarly journals 61 Impact of Dedicated Geriatrician Involvement on National Emergency Laparotomy Audit Standards and Outcomes

2019 ◽  
Vol 48 (Supplement_3) ◽  
pp. iii1-iii16
Author(s):  
Roisin Coary ◽  
Kath Jenkins ◽  
Emma Mitchell ◽  
Anne Pullyblank ◽  
David Shipway
Keyword(s):  
Older Patients ◽  
Ad Hoc ◽  
Gastrointestinal Surgery ◽  
Emergency Laparotomy ◽  
Published Data ◽  
Mortality And Morbidity ◽  
The United Kingdom ◽  
Service Introduction ◽  
National Emergency ◽  
The Impact

Abstract Background Older patients undergoing emergency laparotomy (EmLap) have high levels of mortality and morbidity. The National Emergency Laparotomy Audit (NELA) in the United Kingdom records processes and outcome measures for patients undergoing EmLap. Recent data shows that geriatrician review is associated with reduced post-surgical mortality (Oliver C.M. et al., British Journal of Anaesthesia 2018). Geriatrician review of all patients aged ≥70 years is a NELA standard. However, the most recent national report shows only 23% compliance, falling short of the target of 80% and consistently the poorest performing standard. Methods In August 2018, we established a dedicated gastrointestinal surgery liaison service to replace ad hoc geriatrician reviews. We evaluated the impact on NELA standard compliance and patient outcomes. Data were extracted from the local NELA database on all patients aged ≥70 years, for the first six months of the service (September to February). These were compared to the same time period in the preceding year prior to service launch. Results Following service introduction, increased numbers of patients aged ≥70 years underwent EmLap: 50 (2018-9) vs 31 (2017-8). Geriatrician review occurred in 86% (n=43) in 2018-9, compared to 16% (n=5) in 2017-8. Inpatient mortality fell from 23% (n=7) in 2017-8 to 14% (n=7) in 2018-9. Discharge to own home rose to 76% (n=38) in 2018-9 from 68% (n=21) in 2017-8. One patient in each cohort was newly discharged to a nursing home. Mean length of stay was 17.9 days in 2018-9 (range 3-75), versus 17.6 in 2017-8 (range 3-94). Conclusion Introduction of a dedicated geriatric surgical liaison service is associated with increased compliance with NELA standards. Despite more emergency laparotomies being performed on older patients, this was associated with improved mortality and rates of home discharge, consistent with published data. Targeted investment in surgical liaison services may therefore be warranted.

Hidden Politics? Assessing Lobbying Success During US Agency Guidance Development

2020 ◽  
Vol 30 (4) ◽  
pp. 548-562 ◽  
Author(s):  
Susan Webb Yackee
Keyword(s):  
Interest Groups ◽  
Development Process ◽  
Guidance Document ◽  
Public Attention ◽  
Policy Success ◽  
Government Documents ◽  
Us Government ◽  
Guidance Documents ◽  
The Relationship ◽  
Guidance Development

Abstract I test the proposition that interest groups achieve greater policy success when they lobby during the agency guidance document development process as opposed to the notice and comment process. Policymaking via guidance documents often receives lower levels of public attention, which provides greater flexibility to accommodate lobbying requests. I analyze the hypothesis during the creation of 41 rules by one US government agency—20 of which were promulgated using the notice and comment process and 21 via the guidance document process. I measure regulatory policy change using a content analysis of government documents and lobbying texts, and I also incorporate a telephone survey of interest groups who lobbied on these same rules. I find that interest groups perceive—and achieve—greater policy success when lobbying during the agency guidance process. The results yield new insights into the relationship between lobbying and regulatory policymaking.

scholarly journals Joint inversion of proxy system models to reconstruct paleoenvironmental time series from heterogeneous data

2020 ◽  
Vol 16 (1) ◽  
pp. 65-78 ◽  
Author(s):  
Gabriel J. Bowen ◽  
Brenden Fischer-Femal ◽  
Gert-Jan Reichart ◽  
Appy Sluijs ◽  
Caroline H. Lear
Keyword(s):  
Time Series ◽  
Ad Hoc ◽  
Joint Inversion ◽  
Environmental Variable ◽  
Heterogeneous Data ◽  
Published Data ◽  
Model Parameters ◽  
Qualitative Comparison ◽  
Bayesian Hierarchical ◽  
Proxy Reconstructions

Abstract. Paleoclimatic and paleoenvironmental reconstructions are fundamentally uncertain because no proxy is a direct record of a single environmental variable of interest; all proxies are indirect and sensitive to multiple forcing factors. One productive approach to reducing proxy uncertainty is the integration of information from multiple proxy systems with complementary, overlapping sensitivity. Mostly, such analyses are conducted in an ad hoc fashion, either through qualitative comparison to assess the similarity of single-proxy reconstructions or through step-wise quantitative interpretations where one proxy is used to constrain a variable relevant to the interpretation of a second proxy. Here we propose the integration of multiple proxies via the joint inversion of proxy system and paleoenvironmental time series models in a Bayesian hierarchical framework. The “Joint Proxy Inversion” (JPI) method provides a statistically robust approach to producing self-consistent interpretations of multi-proxy datasets, allowing full and simultaneous assessment of all proxy and model uncertainties to obtain quantitative estimates of past environmental conditions. Other benefits of the method include the ability to use independent information on climate and environmental systems to inform the interpretation of proxy data, to fully leverage information from unevenly and differently sampled proxy records, and to obtain refined estimates of proxy model parameters that are conditioned on paleo-archive data. Application of JPI to the marine Mg∕Ca and δ18O proxy systems at two distinct timescales demonstrates many of the key properties, benefits, and sensitivities of the method, and it produces new, statistically grounded reconstructions of Neogene ocean temperature and chemistry from previously published data. We suggest that JPI is a universally applicable method that can be implemented using proxy models of wide-ranging complexity to generate more robust, quantitative understanding of past climatic and environmental change.

The Sea-Water Well System at the Fisheries Laboratory, Lowestoft and the Methods in Use for Keeping Marine Fish

1980 ◽  
Vol 60 (1) ◽  
pp. 215-225 ◽  
Author(s):  
P. Scholes
Keyword(s):  
Marine Fish ◽  
Open System ◽  
Ad Hoc ◽  
Sea Water ◽  
International Council ◽  
The Public ◽  
Practical Operation ◽  
Water Well ◽  
Pros And Cons ◽  
Methods Of Operation

Facilities for keeping marine fish for experimental purposes or for display to the public are usually run on either an open system with direct supplies of water from the sea, as in the Bergen Aquarium (Rollefsen, 1962), or on a mainly closed system in which the sea water is continually recirculated (Saeki, 1958). The pros and cons of each system are well known and have been discussed in the published papers of the 1960 1st International Congress of Aquarology held in Monaco (Comité Scientifique et Technique du Congrés International d'Aquariologie, 1962–63) and in the report of the ad hoc meeting in 1975 on design and practical operation of research aquarium systems held at Texel, The Netherlands (International Council for the Exploration of the Sea, 1975). A combination of the two types of system is often used in research institutions and series of papers on sea-water aquarium designs and methods of operation have been collected by Clark & Clark (1964).

scholarly journals Critical care transfer in an English critical care network: Analysis of 1124 transfers delivered by an ad-hoc system

2019 ◽  
Vol 21 (1) ◽  
pp. 33-39 ◽  
Author(s):  
Scott Grier ◽  
Graham Brant ◽  
Timothy H Gould ◽  
Johannes von Vopelius-Feldt ◽  
Julian Thompson
Keyword(s):  
Critical Care ◽  
Ad Hoc ◽  
Published Data ◽  
National Guidelines ◽  
Care Network ◽  
National Conversation ◽  
Hospital Transfer ◽  
Specialist Treatment ◽  
Transfer Services ◽  
Time Critical

Background Critical care transfers between hospitals are time critical high-risk episodes for unstable patients who often require urgent lifesaving intervention. This study aimed to establish the scale, nature and safety of current transfer practice in the South West Critical Care Network (SWCCN) in England. Methods The SWCCN database contains prospectively collected data in accordance with national guidelines. It was interrogated for all adult (>15 years of age) patients from January 2012 to November 2017. Results A total of 1124 inter-hospital transfers were recorded, with the majority (935, 83.2%) made for specialist treatment. The transferring team included a doctor in 998 (88.8%) and nurse in 935 (93.7%) transfers. In 204 (18.1%) transfers, delays occurred, with the commonest cause being availability of transport. Critical incidents occurred in 77 (6.9%). Conclusions This is the first published data on the transfer activity of a UK adult critical care network. It demonstrates that current ad-hoc provision is not meeting the longstanding expectations of national guidelines in terms of training, clinical experience and timeliness. The authors hope that this study may inform national conversation regarding the development of National Health Service commissioned inter-hospital transfer services for adult patients in England.

Survey of Modalities of Toxicity Assessment and Reporting in Noncomparative Prospective Studies of Chemotherapy in Breast Cancer

2002 ◽  
Vol 20 (1) ◽  
pp. 52-57 ◽  
Author(s):  
Francesco Perrone ◽  
Ermelinda De Maio ◽  
Paolo Maione ◽  
Massimo Di Maio ◽  
Alessandro Ottaiano ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Phase Ii ◽  
Ad Hoc ◽  
Statistical Design ◽  
Toxicity Assessment ◽  
The Body ◽  
World Health ◽  
Published Data ◽  
Hematologic Toxicity ◽  
Phase Ii Studies

PURPOSE: To review how toxicity, a main end point of phase II studies, is assessed and reported in published phase II chemotherapy trials in breast cancer. METHODS: A survey was performed by hand-searching studies published in seven distinguished journals between 1995 and 1999. All selected articles were independently evaluated by two investigators using an ad hoc study report form. Descriptive statistics, contingency tables, and the χ2 test were applied. RESULTS: Overall, 122 articles were found; 65.6% lacked a statistical study design. Planned modalities for assessment of toxicity were inadequately reported in 20.5% of the studies. The scheduling of assessment of hematologic toxicity varied greatly. Toxicity was predominantly summarized per patient (69.7%). Although overall the World Health Organization scale was adopted more frequently (45.9%), the Common Toxicity Criteria (in different versions) were used more frequently in studies published in journals with a high impact factor (P = .001), in more recently initiated studies (P = .03), in sponsored studies (P = .0006), and in studies with an identifiable statistical design (P = .006). CONCLUSION: The wide diversity in modalities of toxicity assessment and reporting observed in this study suggests that the reliability of the body of published data on the toxicity of chemotherapy in breast cancer may be questionable. Current standards should be revised and harmonized to improve the reliability of such data. A checklist is proposed to help editorial evaluation of assessment and reporting of toxicity in phase II studies.

scholarly journals Infectious Diseases Society of America Guidance on the Treatment of AmpC β-lactamase-Producing Enterobacterales, Carbapenem-Resistant Acinetobacter baumannii, and Stenotrophomonas maltophilia Infections

2021 ◽  
Author(s):  
Pranita D Tamma ◽  
Samuel L Aitken ◽  
Robert A Bonomo ◽  
Amy J Mathers ◽  
David van Duin ◽  
...  
Keyword(s):  
Infectious Diseases ◽  
Acinetobacter Baumannii ◽  
Stenotrophomonas Maltophilia ◽  
The United States ◽  
Causative Organism ◽  
Published Data ◽  
Guidance Document ◽  
Duration Of Therapy ◽  
Carbapenem Resistant ◽  
Pediatric Populations

Abstract Background The Infectious Diseases Society of America (IDSA) is committed to providing up-to-date guidance on the treatment of antimicrobial-resistant infections. A previous guidance document focused on infections caused by extended-spectrum β-lactamase-producing Enterobacterales (ESBL-E), carbapenem-resistant Enterobacterales (CRE), and Pseudomonas aeruginosa with difficult-to-treat resistance (DTR-P. aeruginosa). Here, guidance is provided for treating AmpC β-lactamase-producing Enterobacterales (AmpC-E), carbapenem-resistant Acinetobacter baumannii (CRAB), and Stenotrophomonas maltophilia infections. Methods A panel of six infectious diseases specialists with expertise in managing antimicrobial-resistant infections formulated questions about the treatment of AmpC-E, CRAB, and S. maltophilia infections. Answers are presented as suggestions and corresponding rationales. In contrast to guidance in the previous document, published data on optimal treatment of AmpC-E, CRAB, and S. maltophilia infections are limited. As such, guidance in this document is provided as “suggested approaches” based on clinical experience, expert opinion, and a review of the available literature. Because of differences in the epidemiology of resistance and availability of specific anti-infectives internationally, this document focuses on the treatment of infections in the United States. Results Preferred and alternative treatment suggestions are provided, assuming the causative organism has been identified and antibiotic susceptibility results are known. Approaches to empiric treatment, duration of therapy, and other management considerations are also discussed briefly. Suggestions apply for both adult and pediatric populations. Conclusions The field of antimicrobial resistance is highly dynamic. Consultation with an infectious diseases specialist is recommended for the treatment of antimicrobial-resistant infections. This document is current as of September 17, 2021 and will be updated annually. The most current versions of IDSA documents, including dates of publication, are available at www.idsociety.org/practice-guideline/amr-guidance-2.0/.

scholarly journals “Languaging” tacit judgment in formal postgraduate assessment: the documentation of ad hoc and summative entrustment decisions

2020 ◽  
Vol 9 (6) ◽  
pp. 373-378 ◽  
Author(s):  
Anneke van Enk ◽  
Olle ten Cate
Keyword(s):  
Medical Education ◽  
Ad Hoc ◽  
Published Data ◽  
Assessment Practices ◽  
Competency Based Medical Education ◽  
Empirical Inquiry ◽  
Competency Frameworks ◽  
Gut Feelings ◽  
Written Form ◽  
Competency Based

AbstractWhile subjective judgment is recognized by the health professions education literature as important to assessment, it remains difficult to carve out a formally recognized role in assessment practices for personal experiences, gestalts, and gut feelings. Assessment tends to rely on documentary artefacts—like the forms, standards, and policies brought in under competency-based medical education, for example—to support accountability and fairness. But judgment is often tacit in nature and can be more challenging to surface in explicit (and particularly written) form. What is needed is a nuanced approach to the incorporation of judgment in assessment such that it is neither in danger of being suppressed by an overly rigorous insistence on documentation nor uncritically sanctioned by the defense that it resides in a black box and that we must simply trust the expertise of assessors. The concept of entrustment represents an attempt to effect such a balance within current competency frameworks by surfacing judgments about the degree of supervision learners need to care safely for patients. While there is relatively little published data about its implementation as yet, one readily manifest variation in the uptake of entrustment relates to the distinction between ad hoc and summative forms. The ways in which these forms are languaged, together with their intended purposes and guidelines for their use, point to directions for more focused empirical inquiry that can inform current and future uptake of entrustment in competency-based medical education and the responsible and meaningful inclusion of judgment in assessment more generally.

scholarly journals Compilation of International Standards and Regulatory Guidance Documents for Evaluation of Biomaterials, Medical Devices, and 3-D Printed and Regenerative Medicine Products

2018 ◽  
Vol 47 (3) ◽  
pp. 344-357 ◽  
Author(s):  
JoAnn C. L. Schuh ◽  
Kathleen A. Funk
Keyword(s):  
Regenerative Medicine ◽  
Medical Device ◽  
International Standards ◽  
International Organization ◽  
Medical Products ◽  
Regulatory Guidance ◽  
Good Laboratory ◽  
Standards And Guidelines ◽  
Guidance Documents ◽  
Country Specific

The development of biomaterials, medical device components, finished medical products, and 3-D printed and regenerative medicine products is governed by a variety of international and country-specific standards and guidelines. Of greatest importance to planning, executing, and reporting biocompatibility, safety and efficacy studies for most biomaterials and medical components or products are the International Organization for Standardization guidelines, U.S. Pharmacopeial Convention, ASTM International, and Conformité Européenne (European Conformity) marking. The International Medical Device Regulators Forum publishes harmonized standards similar to the International Council for Harmonization. Good Laboratory Practices are applicable and guidance documents for the development of drugs and biologics can also be relevant to biomaterials, medical device components, and medical products and more recently to products produced by 3-D printing or additive manufacturing. Regenerative products may have medical device–based scaffolding and may be treated as biologics, reflecting the cell and tissue components. This compilation of international standards and guidelines provides toxicologic pathologists, toxicologists, bioengineers, and allied professionals with an overview of and source for important regulatory documents that may apply to the nonclinical development of their products.

scholarly journals Managing Water Quality in Premise Plumbing: Subject Matter Experts’ Perspectives and a Systematic Review of Guidance Documents

Water ◽  
2020 ◽  
Vol 12 (2) ◽  
pp. 347 ◽  
Author(s):  
Rajveer Singh ◽  
Kerry A. Hamilton ◽  
Md Rasheduzzaman ◽  
Zhao Yang ◽  
Saurajyoti Kar ◽  
...  
Keyword(s):  
Water Quality ◽  
Water Temperature ◽  
Subject Matter ◽  
Opportunistic Pathogen ◽  
Hot Water ◽  
Guidance Document ◽  
Subject Matter Experts ◽  
Water Heater ◽  
Expert Opinions ◽  
Guidance Documents

Although many guidance documents have been developed to inform the design and operation of building water systems to ensure safe water quality, there is a lack of consensus on some topics. This study interviewed 22 subject matter experts (SMEs) to identify topics of concern for managing water quality in buildings and compared SME views with information available on these topics in 15 systematically screened important guidance documents. The study found 18 design and 11 operational topics as critical for managing water quality in buildings. No one guidance document addressed all these topics, suggesting that a compendium of available guidance is needed. SMEs most frequently recommended temperature and residual disinfectant measurements as good parameters for monitoring overall building water quality. Both SME and guidance document recommendations for temperature for controlling opportunistic pathogen growth were reasonably consistent with water heater setpoint >60 °C. However, hot water temperature recommendations varied between 50 and 55 °C for other locations (i.e., the water temperature at the tap or end of the return loop). On the contrary, recommendations for disinfectant residual levels (0.2–2.0 mg/L), flushing frequency (1–14 days), and allowable time for hot water to reach the tap (10–60 s) were not consistent. While this study was able to reconcile diverging views on some of the water quality topics, such as identifying common guidance for water heater set point to at least 60 °C, it also highlights lack of definitive guidance on other critical topics, such as residual level, flushing frequency, hot water time to tap, and the use of thermostatic mixing valves, indicating that these are significant knowledge gaps that need further investigation. The study concludes that there is a need for developing evidence-based guidance, particularly on the topics where expert opinions diverged.

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