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Application of implementation science for improving the utilization of an international clinical practice guidance on familial hypercholesterolemia

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JOURNAL OF CLINICAL LIPIDOLOGY 2024年第4期18卷 e525-e536页

作者： Jones, Laney K. Gidding, Samuel S. Santos, Raul D. Libby, Peter Watts, Gerald F. Sarkies, Mitchell N. Geisinger Dept Genom Hlth Danville PA USA Geisinger Heart & Vasc Inst Danville PA USA Univ Sao Paulo Heart Inst InCor Lipid Clin Sao Paulo Brazil Hosp Israelita Albert Einstein Sao Paulo Brazil Brigham & Womens Dept Med Div Cardiovasc Med Boston MA USA Harvard Med Sch Boston MA USA Univ Western Australia Sch Med Perth WA Australia Royal Perth Hosp Dept Cardiol & Internal Med Perth WA Australia Univ Sydney Fac Med & Hlth Sch Hlth Sci Sydney NSW Australia Univ Sydney Implementat Sci Acad Sydney Hlth Partners Sydney NSW Australia

BACKGROUND: The International Atherosclerosis Society (IAS) published an evidence-informed guidance for familial hypercholesterolemia (FH) that provides both clinical and implementation recommendations. We reference examples of strategies from the literature to explore how these implementation recommendations can be tailored into implementation strategies at the local-level for stakeholders guided by a framework proposed by Sarkies and Jones. METHODS: Four authors of the IAS guidance selected two published exemplar implementation recommendations for detection, management, and general implementation. Each recommendation was described as an implementation strategy using Proctor's guidance for specifying and reporting implementation strategies. It recommends reporting the actor (who), action (what), action-target (who is impacted), temporality (how often), and dose (how much) for each implementation strategy. RESULTS: Detection: A centralized cascade testing model, mobilized nurses (actor) to relative's homes, after the diagnosis of the proband (temporality), once (dose) to consent, obtain a blood sample and health information (action) on relatives (action-target). Management: A primary care initiative to improve FH management included an educational session (action) with clinicians (action-target), computer-based reminder message and message to patients to have their cholesterol screened once (dose) at a visit or outreach (temporality) by researchers (actor). General: A partnership between a statewide public pathology provider, local public hospital network, primary health network, government health ministry, and an academic university (actors) was established to implement a primary-tertiary shared care model (action) to improve the detection of FH (action-target). CONCLUSIONS: We demonstrate that implementation recommendations can be specified and reported for different local contexts with examples on monitoring, evaluation, and sustainability in practice.

关键词： Implementation science Familial hypercholesterolemia guidance Guidelines Detection Management

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Cost-effectiveness of Procalcitonin (PCT) guidance for antibiotics management of adult sepsis patients in the Egyptian context

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BMC HEALTH SERVICES RESEARCH 2024年第1期24卷 1页

作者： Mosly, Mohamed Metwally Mousli, Hesham Metwalli Ahmed, Iman Mohamed Momtaz Abdou, Mohamed Ibrahim Affify Arab Acad Sci Technol & Maritime Transport AASTMT Coll Pharm Dept Pharm Practice Alexandria Egypt Alexandria Univ Alexandria Med Res Inst MRI Dept Biomed Informat & Med Stat Alexandria Egypt Andalusia Shalalt Hosp HOD Clin Pharm Alexandria Egypt Cairo Univ Crit Care Med Cairo Egypt

BackgroundSepsis, which is described as a life-threatening organ malfunction brought on by an unbalanced host response to infection, continues to be a significant healthcare issue that affects millions of individuals each year. It is well-known that sepsis can affect anyone around the world, but the employed survey results showed that there are significant regional variations in sepsis incidence as well as mortality rates. Although there are no definite estimates for Egypt, the highest rates were in Low-Middle-Income Countries (LMICs).Procalcitonin (PCT) is a host response marker with high specificity for bacterial infections, unlike C-reactive protein (CRP) or white blood cell count (WBC), which represent the traditional methods of detecting inflammation and infection. Its dynamic profile and superior prognostic prediction make it invaluable for assessing response to antibiotic treatment and improving clinical care for sepsis *** main purpose was to evaluate the cost-effectiveness of PCT guidance compared to no PCT guidance in the antibiotic management of adult sepsis patients according to the Egyptian ***, which is described as a life-threatening organ malfunction brought on by an unbalanced host response to infection, continues to be a significant healthcare issue that affects millions of individuals each year. It is well-known that sepsis can affect anyone around the world, but the employed survey results showed that there are significant regional variations in sepsis incidence as well as mortality rates. Although there are no definite estimates for Egypt, the highest rates were in Low-Middle-Income Countries (LMICs).Procalcitonin (PCT) is a host response marker with high specificity for bacterial infections, unlike C-reactive protein (CRP) or white blood cell count (WBC), which represent the traditional methods of detecting inflammation and infection. Its dynamic profile and superior prognostic prediction make it invaluable for ass

关键词： Cost-Effectiveness Procalcitonin guidance Sepsis Egyptian

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Scoping review of the recommendations and guidance for improving the quality of rare disease registries

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ORPHANET JOURNAL OF RARE DISEASES 2024年第1期19卷 187页

作者： Tarride, J. E. Okoh, A. Aryal, K. Prada, C. Milinkovic, Deborah Keepanasseril, A. Iorio, A. McMaster Univ Fac Hlth Sci Dept Hlth Res Methods Evidence & Impact Hamilton ON Canada McMaster Univ Ctr Hlth Econ & Policy Anal CHEPA Hamilton ON Canada Res Inst St Joes Hamilton Programs Assessment Technol Hlth PATH St Josephs Healthcare Hamilton Hamilton ON Canada

Background Rare disease registries (RDRs) are valuable tools for improving clinical care and advancing research. However, they often vary qualitatively, structurally, and operationally in ways that can determine their potential utility as a source of evidence to support decision-making regarding the approval and funding of new treatments for rare *** The goal of this research project was to review the literature on rare disease registries and identify best practices to improve the quality of *** In this scoping review, we searched MEDLINE and EMBASE as well as the websites of regulatory bodies and health technology assessment agencies from 2010 to April 2023 for literature offering guidance or recommendations to ensure, improve, or maintain quality *** The search yielded 1,175 unique references, of which 64 met the inclusion criteria. The characteristics of RDRs deemed to be relevant to their quality align with three main domains and several sub-domains considered to be best practices for quality RDRs: (1) governance (registry purpose and description;governance structure;stakeholder engagement;sustainability;ethics/legal/privacy;data governance;documentation;and training and support);(2) data (standardized disease classification;common data elements;data dictionary;data collection;data quality and assurance;and data analysis and reporting);and (3) information technology (IT) infrastructure (physical and virtual infrastructure;and software infrastructure guided by FAIR principles (Findability;Accessibility;Interoperability;and Reusability).Conclusions Although RDRs face numerous challenges due to their small and dispersed populations, RDRs can generate quality data to support healthcare decision-making through the use of standards and principles on strong governance, quality data practices, and IT infrastructure.

关键词： Rare diseases Registries Quality standards guidance

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A Taxonomy Development Method to Define the Vocabulary for Rule-Based guidance in Complex Emerging Technologies

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BUSINESS & INFORMATION SYSTEMS ENGINEERING 2024年第2期66卷 161-180页

作者： Mwilu, Odette Sangupamba Prat, Nicolas Comyn-Wattiau, Isabelle Univ Catholique Congo Fac Publ Hlth Ave Univ 2BP 1534 Kinshasa Limete Rep Congo Univ Pedag Natl Dept Comp Technol Croisement Route Matadi & Ave LiberatBP 8815 Kinshasa Ngaliema Rep Congo ESSEC Business Sch Ave Bernard Hirsch BP 50105 F-95021 Cergy France

Emerging technologies are characterized by their uncertainty and potential impact. Decisions about these technologies are therefore crucial and difficult. The problem is particularly acute for complex emerging technologies, which combine several technologies. guidance on emerging technologies is often lacking, even more for complex ones. In this research, methods and models to guide practitioners (members of the IT personnel) in the adoption of complex emerging technologies are defined. guidance is provided by means of productions rules, requiring a controlled vocabulary organized as a taxonomy. The rules, and the vocabulary for the rules, are defined by researchers for a specific complex emerging technology (e.g., business intelligence and analytics in the cloud). They may then be applied by practitioners to decide on the adoption of the emerging technology in a specific organizational context. The approach is based on systematic literature review, thereby contributing to evidence-based practice. This paper focuses on the method to define the controlled vocabulary for the production rules. This taxonomy development method is built by combining systematic literature review with a method for taxonomy development, considering the specificities of rule-based guidance and complex emerging technologies. It is demonstrated on business intelligence and analytics in the cloud and evaluated in a government agency.

关键词： Emerging technology guidance Taxonomy Systematic literature review

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Clinical guidance for choosing the right pharmacotherapy for migraine attacks

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EXPERT OPINION ON PHARMACOTHERAPY 2024年第1期25卷 37-44页

作者： Domitrz, Izabela Med Univ Warsaw Bielanski Hosp Fac Med & Dent Dept Neurol Ceglowska 80 PL-01809 Warsaw Poland

Introduction: Migraine as headache attacks with autonomic symptoms is a serious condition and it is important to treat a single attack effectively in order to improve not only the patient's quality of life at a given moment but also to prevent the migraine from becoming a chronic *** covered: The article briefly presents the guidance in selecting the most appropriate pharmacological treatment of migraine attack, indicating a personalized approach to migraine *** opinion: In this short paper, we show the implementation of new drugs into everyday clinical practice. Good cooperation between the physician and the patient and having the patient's trust is one of the elements of a personalized therapeutic approach and the key to achieving satisfaction of both the patient and the doctor.

关键词： Ditans gepants guidance migraine attack Nsaids recommendation simple analgetics triptans

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Comparison of societal guidance on perioperative management of glucagon-like peptide-1 receptor agonists: implications for clinical practice and future investigations

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CANADIAN JOURNAL OF ANESTHESIA-JOURNAL CANADIEN D ANESTHESIE 2024年第9期71卷 1302-1315页

作者： Chang, Marvin G. Bittner, Edward A. Harvard Med Sch Massachusetts Gen Hosp Dept Anesthesia Crit Care & Pain Med Boston MA 02115 USA Massachusetts Gen Hosp 55 Fruit StWhite 437 Boston MA 02114 USA

PurposeThe use of glucagon-like peptide-1 (GLP-1) receptor agonists (RAs) by patients undergoing surgery and procedures requiring anesthesia has become a topic of significant concern for perioperative providers because of the potential increased risk of aspiration resulting from the medication's effect of delaying gastric emptying. There is currently a lack of high-quality data regarding the safety of GLP-1 RAs in patients undergoing surgery, which has led to variations in *** performed an internet search of society-endorsed statements and guidelines related to perioperative management of GLP-1 RAs, focusing on the top 20 countries with the largest anesthesiology societies determined by membership data from the World Federation of Societies of Anesthesiologists. We excluded articles and websites that were not in *** findingsOur search revealed endorsed statements from fourteen major anesthesiology, endocrinology, and gastroenterology societies. There was considerable variation between societies in the recommendations and guidance for withholding these medications before surgery, the duration of withholding, assessment of the need for avoiding deep sedation or general anesthesia, use of rapid sequence intubation, need for prolonged fasting periods and clear fluid before a nil per os period, recognition of signs and symptoms for aspiration risk, the management of glucose in the perioperative period, and the use of point-of-care ultrasound for risk ***-endorsed statements and guidelines provide varying recommendations on the perioperative management of GLP-1 RAs. The insights gained from this comparative analysis may help guide clinical practice, develop institutional practice guidelines, and direct future research efforts. ObjectifL'utilisation d'agonistes des r & eacute;cepteurs (AR) du peptide-1 de type glucagon (GLP-1) par les personnes b & eacute;n & eacute;ficiant d'une intervention chirurgicale et de proc & ea

关键词： anesthesia anesthesiology aspiration aspiration risk gastric emptying GLP-1 RA GLP-1 receptor agonists guidance guidelines procedures surgery

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ICSH guidance for internal quality control policy for blood cell counters

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INTERNATIONAL JOURNAL OF LABORATORY HEMATOLOGY 2024年第2期46卷 227-233页

作者： McCafferty, Richard Cembrowski, George de la Salle, Barbara Peng, Mingting Urrechaga, Eloisa St James Hosp Haematol Dept Dublin Ireland Univ Alberta Edmonton AB Canada UK NEQAS Watford England NCCL Beijing Peoples R China Hosp Galdakao Usansolo Haematol Dept Galdakao Spain St James Hosp Haematol Dept Jamess St Dublin D08 K0Y5 Ireland

This paper is a description of the ICSH guidance for internal quality control (IQC) policy for blood cell counters. It follows from and links to a separate ICSH review for such policies and practices. The ICSH has gathered information regarding the current state of practice through review of published guidance from regulatory bodies, a questionnaire to six major cell counter manufacturers and a survey issued to 191 diagnostic laboratories in four countries (China, the Republic of Ireland, Spain, and the United Kingdom) on their IQC practice and approach to the use of commercial IQC materials. This has revealed diversity both in guidance and in practice around the world. There is diversity in guidance from regulatory organizations in regard to IQC methods each recommends, clinical levels to use and frequency to run commercial controls, and finally recommended sources of commercial control materials. The diversity in practice among clinical laboratories spans the areas of IQC methods used, derivation of target values, and action limits used with commercial control materials, and frequency of running commercial controls materials. These findings and their implications for IQC Practice are addressed in this guidance document, which proposes a harmonized approach to address the issues faced by diagnostic laboratories.

关键词： cell counters general haematology guidance ICSH quality control

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Using qualitative comparative analysis as a mixed methods synthesis in systematic mixed studies reviews: guidance and a worked example

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RESEARCH SYNTHESIS METHODS 2024年第3期15卷 450-465页

作者： El Sherif, Reem Pluye, Pierre Hong, Quan Nha Rihoux, Benoit McGill Univ Dept Family Med Suite 300 Ch Cotes Des Neiges Montreal PQ H3S 1Z1 Canada Univ Montreal Sch Rehabil Montreal PQ Canada Ctr Interdisciplinary Res Rehabil Greater Montreal Montreal PQ Canada Univ Louvain Inst Polit Sci Louvain Europe ISPOLE Dept Polit & Social Sci Louvain La Neuve Belgium

Qualitative comparative analysis (QCA) is a hybrid method designed to bridge the gap between qualitative and quantitative research in a case-sensitive approach that considers each case holistically as a complex configuration of conditions and outcomes. QCA allows for multiple conjunctural causation, implying that it is often a combination of conditions that produces an outcome, that multiple pathways may lead to the same outcome, and that in different contexts, the same condition may have a different impact on the outcome. This approach to complexity allows QCA to provide a practical understanding for complex, real-world situations, and the context of implementing interventions. There are guides for conducting QCA in primary research and quantitative systematic reviews yet, to our knowledge, no guidance for conducting QCA in systematic mixed studies reviews (SMSRs). Thus, the specific objectives of this paper are to (1) describe a step-by-step approach for novice researchers for using QCA to integrate qualitative and quantitative evidence, including guidance on how to use software;(2) highlight specific challenges;(3) propose potential solutions from a worked example;and (4) provide recommendations for reporting.

关键词： guidance qualitative comparative analysis systematic mixed studies reviews worked example

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Determining the state of guidance on pediatric biobanking for researchers, HRECS, and families: Regulatory mapping of international guidance

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EUROPEAN JOURNAL OF PEDIATRICS 2024年第5期183卷 2477-2490页

作者： Prince, Sinead Then, Shih-Ning O'Grady, Kerry-Ann Queensland Univ Technol Fac Business & Law Australian Ctr Hlth Law Res Brisbane Qld Australia Queensland Univ Technol Australian Ctr Hlth Serv Innovat Ctr Healthcare Transformat Brisbane Qld Australia

Biobanking-the storage of human biological samples, including tissue, blood, urine, and genetic data-raises many ethical, legal, and social issues, including confidentiality and privacy. Pediatric biobanking is more complicated, with difficulties arising because children lack capacity to consent and acquire this capacity upon maturity when the research is still ongoing. Yet given the limited availability of pediatric samples, the translational nature of biobanking presents a unique opportunity to share samples and produce clinically necessary information about pediatric development and diseases. guidance on navigating these legal and ethical difficulties is needed for those involved in pediatric biobanking-including researchers, participants, and families, and those involved in biobank governance. This paper seeks to map the current regulatory framework governing pediatric biobanking to determine what guidance is currently offered. Regulatory mapping of current international and national guidelines on pediatric biobanking addressing the ethical, legal, and social nuances of pediatric biobanking was undertaken. This paper finds that international guidelines around biobanking are mostly for adults, and even when pediatric-specific, documents are non-binding, inconsistent, or only limited guidance is offered on a range of important issues specific to pediatric biobanks. Conclusion: This paper shows a need for consistent, comprehensive, and clear regulation on pediatric biobanking so that research can more quickly, efficiently, and ethically be translated to useful information and treatment in pediatric *** is Known:center dot Pediatric biobanking presents new opportunities to conduct valuable translational research to benefit pediatric populations. However, the storage of pediatric biological samples raises many ethical, legal and social issues-in part because child participants may be considered to lack capacity to consent but can acquire this capacity upon matu

关键词： Pediatric Biobank Regulation guidance Law Ethics

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guidance to inform research recruitment processes for studies involving critically ill patients

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JOURNAL OF THE INTENSIVE CARE SOCIETY 2024年第1期25卷 95-101页

作者： Woolfall, Kerry Paddock, Katie Watkins, Megan Kearney, Anna Neville, Katie Frith, Lucy Welters, Ingeborg Gamble, Carrol Trinder, John Pattison, Natalie White, Catherine Brett, Stephen Dilworth, Steve Ross, Mike Mouncey, Paul Rowan, Kathy Dawson, Angus Collet, Clive Walsh, Tim Young, Bridget Univ Liverpool Inst Populat Hlth Dept Publ Hlth Policy & Syst Liverpool England Manchester Metropolitan Univ Fac Hlth & Educ Sch Childhood Youth & Educ Studies Manchester England Royal Coll Psychiatrists Natl Collaborating Ctr Mental Hlth London England Univ Liverpool Inst Populat Hlth Dept Hlth Data Sci Liverpool England Univ Manchester Ctr Social Eth & Policy Manchester England Univ Liverpool Inst Life Course & Med Sci Liverpool England Liverpool Univ Hosp NHS Fdn Trust Dept Crit Care Liverpool England South Eastern Hlth & Social Serv Trust Ulster Hosp Belfast North Ireland Univ Hertfordshire Stevenage England East & North Herts NHS Trust Stevenage England ICU Steps London England Imperial Coll London London England Imperial Coll Healthcare NHS Trust London England ICU Steps PPI Partner London England PPI Partner London England Intens Care Natl Audit & Res Ctr London England Natl Univ Singapore Ctr Biomed Eth Singapore Singapore Hlth Res Author London England Univ Edinburgh Edinburgh Scotland Univ Liverpool Inst Populat Hlth Dept Publ Hlth Policy & Syst Whelan Bldg Liverpool L69 3BX England

Clinical research in intensive care units (ICUs) is essential for improving treatments for critically ill patients. However, invitations to participate in clinical research in this situation pose numerous challenges. Studies are frequently initiated within a narrow time window when patients are often unconscious and unable to consent. Consultations or consent discussions must therefore be held with consultees or representatives, usually the patient's relatives. Conversations about research participation in this setting may be difficult, as relatives are often overwhelmed and may feel uneasy about making decisions on behalf of their relatives. In some circumstances, legislation allows doctors to act as consultees or representatives to enrol patients in research. However, there is little good quality evidence on UK stakeholders' perspectives to inform how recruitment is carried out in ICU studies. The Perspectives Study collected evidence on the views of over 1400 stakeholders, including patients, relatives and healthcare practitioners, many of whom had first-hand experience of ICU treatment and research. This evidence was used to inform good practice guidance on recruitment of critically ill patients to research. Established social science methods and empirical ethics were employed to reflect the interests of stakeholders and justify recommendations. This guidance aims to bridge the gap between the legal frameworks and the realities of ICU studies and to ensure that research recruitment processes reflect the views of patients and families. Researchers and an expert Advisory Group brought different perspectives to interpreting the evidence to develop the guidance. In this article we present guidance for future ICU studies.

关键词： guidance clinical research recruitment consent critical care

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