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1.
Health Res Policy Syst ; 22(1): 79, 2024 Jul 05.
Article de Anglais | MEDLINE | ID: mdl-38970125

RÉSUMÉ

BACKGROUND: Development of guidelines for public health, health system, and health policy interventions demands complex systems thinking to understand direct and indirect effects of interventions within dynamic systems. The WHO-INTEGRATE framework, an evidence-to-decision framework rooted in the norms and values of the World Health Organization (WHO), provides a structured method to assess complexities in guidelines systematically, such as the balance of an intervention's health benefits and harms and their human rights and socio-cultural acceptability. This paper provides a worked example of the application of the WHO-INTEGRATE framework in developing the WHO guidelines on parenting interventions to prevent child maltreatment, and shares reflective insights regarding the value added, challenges encountered, and lessons learnt. METHODS: The methodological approach comprised describing the intended step-by-step application of the WHO-INTEGRATE framework and gaining reflective insights from introspective sessions within the core team guiding the development of the WHO guidelines on parenting interventions and a methodological workshop. RESULTS: The WHO-INTEGRATE framework was used throughout the guideline development process. It facilitated reflective deliberation across a broad range of decision criteria and system-level aspects in the following steps: (1) scoping the guideline and defining stakeholder engagement, (2) prioritising WHO-INTEGRATE sub-criteria and guideline outcomes, (3) using research evidence to inform WHO-INTEGRATE criteria, and (4) developing and presenting recommendations informed by WHO-INTEGRATE criteria. Despite the value added, challenges, such as substantial time investment required, broad scope of prioritised sub-criteria, integration across diverse criteria, and sources of evidence and translation of insights into concise formats, were encountered. CONCLUSIONS: Application of the WHO-INTEGRATE framework was crucial in the integration of effectiveness evidence with insights into implementation and broader implications of parenting interventions, extending beyond health benefits and harms considerations and fostering a whole-of-society-perspective. The evidence reviews for prioritised WHO-INTEGRATE sub-criteria were instrumental in guiding guideline development group discussions, informing recommendations and clarifying uncertainties. This experience offers important lessons for future guideline panels and guideline methodologists using the WHO-INTEGRATE framework.


Sujet(s)
Maltraitance des enfants , Prise de décision , Pratiques éducatives parentales , Organisation mondiale de la santé , Humains , Maltraitance des enfants/prévention et contrôle , Enfant , Politique de santé , Guides de bonnes pratiques cliniques comme sujet , Participation des parties prenantes , Santé publique , Recommandations comme sujet
2.
BMC Oral Health ; 24(1): 746, 2024 Jun 27.
Article de Anglais | MEDLINE | ID: mdl-38937727

RÉSUMÉ

BACKGROUND: Oral diseases are a major global public health problem, impacting the quality of life of those affected. While consensus exists on the importance of high-quality, evidence-informed guidelines to inform practice and public health decisions in medicine, appropriate methodologies and standards are not commonly adhered to among producers of oral health guidelines. This study aimed to systematically identify organizations that develop evidence-informed guidelines in oral health globally and survey the methodological process followed to formulate recommendations. METHODS: We searched numerous electronic databases, guideline repositories, and websites of guideline developers, scientific societies, and international organizations (January 2012-October 2023) to identify organizations that develop guidelines addressing any oral health topic and that explicitly declare the inclusion of research evidence in their development. Pairs of reviewers independently evaluated potentially eligible organizations according to predefined selection criteria and extracted data about the organization's characteristics, key features of their guidelines, and the process followed when formulating formal recommendations. Descriptive statistics were used to analyze and summarize data. RESULTS: We included 46 organizations that developed evidence-informed guidelines in oral health. The organizations were mainly professional associations and scientific societies (67%), followed by governmental organizations (28%). In total, organizations produced 55 different guideline document types, most of them containing recommendations for clinical practice (77%). Panels were primarily composed of healthcare professionals (87%), followed by research methodologists (40%), policymakers (24%), and patient partners (18%). Most (60%) of the guidelines reported their funding source, but only one out of three (33%) included a conflict of interest (COI) policy management. The methodology used in the 55 guideline document types varied across the organizations, but only 19 (35%) contained formal recommendations. Half (51%) of the guideline documents referred to a methodology handbook, 46% suggested a structured approach or system for rating the certainty of the evidence and the strength of recommendations, and 37% mentioned using a framework to move from evidence to decisions, with the GRADE-EtD being the most widely used (27%). CONCLUSION: Our findings underscore the need for alignment and standardization of both terminology and methodologies used in oral health guidelines with current international standards to formulate trustworthy recommendations.


Sujet(s)
Odontologie factuelle , Santé buccodentaire , Guides de bonnes pratiques cliniques comme sujet , Humains
3.
Heliyon ; 10(10): e30854, 2024 May 30.
Article de Anglais | MEDLINE | ID: mdl-38807883

RÉSUMÉ

Warehouse/distribution center (DC) automation technology for the retail industry promises to reduce operational costs, improve flexibility and response time for customers, and help improve network productivity, thus making it very relevant for omni/multichannel (OC/MC) settings. However, the investment required to acquire the DC automation technology is high, and hence, the investment decision must be operationally and financially comprehensive. In fact, an automated DC has a network-wide impact: it can benefit players in the network, but in turn is exposed to network risks and the investment must be safeguarded. While the need for a comprehensive decision-making framework and safeguarding strategy is stressed by scholars, such a framework is lacking. Further, corresponding integrated sub-frameworks for key elements in the OC/MC value chain are also missing. In this paper, we address these gaps and contribute by providing a) generalized and integrated three-part framework, b) corresponding sub-frameworks, c) discrete event, economic, and math programming models, d) rapid-sizing/analysis tools based on: i) analysis at the DC-level, ii) network level, iii) economic/business level, and iv) contract level (sustainable supplier/distribution relationship). In this reference, we investigate a new generation 'full-case' technology that has been recognized as a key to warehouse automation. The insights from our research inform several strategic tradeoffs (extent of automation, investment in labor vs. capital, response vs. efficiency, and sustainable supplier management) relevant for decision-making and safeguarding an expensive asset such as an automated DC. Our analysis is based on interviews (retailers, automated and conventional DCs, and DC equipment suppliers), on-site observations, secondary data, and learning from analytical models. We also present an illustrative real-life application/case study of the framework and the modeling details in the E-component.

4.
Front Public Health ; 12: 1292475, 2024.
Article de Anglais | MEDLINE | ID: mdl-38584925

RÉSUMÉ

Background: The World Health Organization (WHO) plays a crucial role in producing global guidelines. In response to previous criticism, WHO has made efforts to enhance the process of guideline development, aiming for greater systematicity and transparency. However, it remains unclear whether these changes have effectively addressed these earlier critiques. This paper examines the policy process employed by WHO to inform guideline recommendations, using the update of the WHO Consolidated HIV Testing Services (HTS) Guidelines as a case study. Methods: We observed guideline development meetings and conducted semi-structured interviews with key participants involved in the WHO guideline-making process. The interviews were recorded, transcribed, and analysed thematically. The data were deductively coded and analysed in line with the main themes from a published conceptual framework for context-based evidence-based decision making: introduction, interpretation, and application of evidence. Results: The HTS guideline update was characterized by an inclusive and transparent process, involving a wide range of stakeholders. However, it was noted that not all stakeholders could participate equally due to gaps in training and preparation, particularly regarding the complexity of the Grading Recommendations Assessment Development Evaluation (GRADE) framework. We also found that WHO does not set priorities for which or how many guidelines should be produced each year and does not systematically evaluate the implementation of their recommendations. Our interviews revealed disconnects in the evidence synthesis process, starting from the development of systematic review protocols. While GRADE prioritizes evidence from RCTs, the Guideline Development Group (GDG) heavily emphasized "other" GRADE domains for which little or no evidence was available from the systematic reviews. As a result, expert judgements and opinions played a role in making recommendations. Finally, the role of donors and their presence as observers during GDG meetings was not clearly defined. Conclusion: We found a need for a different approach to evidence synthesis due to the diverse range of global guidelines produced by WHO. Ideally, the evidence synthesis should be broad enough to capture evidence from different types of studies for all domains in the GRADE framework. Greater structure is required in formulating GDGs and clarifying the role of donors through the process.


Sujet(s)
Médecine factuelle , Politique de santé , Médecine factuelle/méthodes , Processus politique , Revues systématiques comme sujet , Organisation mondiale de la santé , Guides de bonnes pratiques cliniques comme sujet
5.
Stat Med ; 43(9): 1688-1707, 2024 Apr 30.
Article de Anglais | MEDLINE | ID: mdl-38373827

RÉSUMÉ

As one of the most commonly used data types, methods in testing or designing a trial for binary endpoints from two independent populations are still being developed until recently. However, the power and the minimum required sample size comparisons between different tests may not be valid if their type I errors are not controlled at the same level. In this article, we unify all related testing procedures into a decision framework, including both frequentist and Bayesian methods. Sufficient conditions of the type I error attained at the boundary of hypotheses are derived, which help reduce the magnitude of the exact calculations and lay out a foundation for developing computational algorithms to correctly specify the actual type I error. The efficient algorithms are thus proposed to calculate the cutoff value in a deterministic decision rule and the probability value in a randomized decision rule, such that the actual type I error is under but closest to, or equal to, the intended level, respectively. The algorithm may also be used to calculate the sample size to achieve the prespecified type I error and power. The usefulness of the proposed methodology is further demonstrated in the power calculation for designing superiority and noninferiority trials.


Sujet(s)
Algorithmes , Plan de recherche , Humains , Théorème de Bayes , Taille de l'échantillon , Probabilité
6.
F1000Res ; 12: 1261, 2023.
Article de Anglais | MEDLINE | ID: mdl-37981981

RÉSUMÉ

Background: Oral diseases are a major global public health problem that impacts the quality of life of those affected. While widespread consensus exists on the importance of high-quality, evidence-informed guidelines to inform practice and public health decisions in medicine, appropriate methodologies and standards are not commonly adhered to among producers of oral health guidelines. This systematic survey aims to identify organizations developing evidence-informed guidelines and policy documents in oral health globally, and describe the methods and processes used. Methods: We will conduct manual searches on the websites of guideline developers, Ministries of Health, and scientific societies. Additionally, we will systematically search electronic databases to identify published guidelines and collect the name of the responsible entity. We will include organizations that regularly develop guidelines on any oral health topic and that explicitly declare the inclusion of research evidence in its development process. Subsequently, we will use a standardized form to extract data about the characteristics of the organization, the characteristics of their guideline or policy documents, and their formal recommendation development processes. These data will be extracted from various sources, such as the organization's official website, the methods section of each guideline, or methodological handbooks. We will use descriptive statistics to analyze the extracted data. Discussion: This systematic survey will synthesize key characteristics and methodologies used by organizations developing evidence-informed guidelines. This study will provide the basis for future development of a sustainable and connected collaborative network for evidence-informed guidelines and policy documents in oral health globally. The results will be disseminated through peer-reviewed publications, conference presentations, and targeted dissemination of findings with the identified organizations. Our systematic survey represents a necessary first step toward improving the field of oral health policies and guidelines.


Sujet(s)
Santé publique , Qualité de vie , Politique (principe) , Bases de données factuelles , Prestations des soins de santé
7.
J Biomed Inform ; 147: 104525, 2023 11.
Article de Anglais | MEDLINE | ID: mdl-37844677

RÉSUMÉ

Indiscriminate use of predictive models incorporating race can reinforce biases present in source data and lead to an exacerbation of health disparities. In some countries, such as the United States, there is therefore a push to remove race from prediction models; however, there are still many prediction models that use race as an input. Biomedical informaticists who are given the responsibility of using these predictive models in healthcare environments are likely to be faced with questions like how to deal with race covariates in these models. Thus, there is a need for a pragmatic framework to help model users think through how to include race in their chosen model so as to avoid inadvertently exacerbating disparities. In this paper, we use the case study of lung cancer screening to propose a simple framework to guide how model users can approach the use (or non-use) of race inputs in the predictive models they are tasked with leveraging in electronic health records and clinical workflows.


Sujet(s)
Dépistage précoce du cancer , Tumeurs du poumon , Humains , États-Unis , Tumeurs du poumon/diagnostic , Dossiers médicaux électroniques
8.
Front Public Health ; 11: 1075210, 2023.
Article de Anglais | MEDLINE | ID: mdl-37064706

RÉSUMÉ

Introduction: Different measures to prevent and control the spread of SARS-CoV-2 have been implemented in German schools. Decisions regarding such measures should be informed by evidence regarding their effectiveness, and their unintended consequences for health and society. A multi-stakeholder panel was convened to develop an evidence- and consensus-based guideline for school measures, using the novel WHO-INTEGRATE framework. Developing a guideline to inform decision-making outside of the clinical realm during a public health emergency was unprecedented in Germany. This study aims to identify lessons learnt for similar endeavours by addressing the following research question: What were the strengths and weaknesses of the guideline development process as perceived by the different groups involved? Methods: Fifteen semi-structured interviews were conducted virtually. We recruited participants aiming to include the perspectives of all groups contributing to the guideline development, including both panel members (scientists, practitioners, school family and observers) and the guideline secretariat. For analysis, we carried out deductive-inductive thematic qualitative text analysis according to Kuckartz, structuring findings using a category system. Results: Due to time pressure, the guideline secretariat was heavily involved not only in synthesising the evidence but also in developing and drafting recommendations. Participants critically reflected on certain methods-related decisions, including the development of draft recommendations and application of the WHO-INTEGRATE framework by scientists only. The full potential of the framework might not have been harnessed. Participants' understanding of relevant and valid evidence varied, and the available evidence base was limited. Participants represented different types of expertise, notably expertise informed by scientific evidence and expertise grounded in lived experience, influencing their involvement in the guideline development process and discussions during meetings. Conclusion: Developing an evidence- and consensus-based public health guideline in only three months was challenging, notably because of the involvement of a broad range of stakeholders and the use of a novel Evidence-to-Decision framework, both unprecedented in Germany. Learning from this process with a view to "institutionalising" the development of public health guidelines and refining methods can contribute to more evidence-informed public health decision-making in Germany and beyond, in general and during a public health emergency.


Sujet(s)
COVID-19 , SARS-CoV-2 , Humains , Santé publique , Consensus , COVID-19/prévention et contrôle , Établissements scolaires
10.
Expert Opin Drug Deliv ; 20(4): 457-470, 2023 04.
Article de Anglais | MEDLINE | ID: mdl-36855292

RÉSUMÉ

INTRODUCTION: The substantial acceleration in healthcare spending together with the expenditures to manage the COVID19 pandemic demand drug delivery solutions that enable a flexible care setting for high-dose monoclonal antibodies (mAbs) in oncology. AREAS COVERED: This expert opinion introduces an analogue-based framework applied to guide decision-making for associated product improvements for mAb medications that are either already authorized or in late-stage clinical development. The four pillars of this framework comprise (1) the drug delivery profile of current and emerging treatments in the market, (2) the needs and preferences of people treated with mAbs, (3) existing healthcare infrastructures, and (4) country-dependent reimbursement and procurement models. The following product optimization examples for mAb-based treatments are evaluated based on original research and review articles in the field: subcutaneous formulations, an established drug delivery modality to reduce parenteral dosing complexity, fixed-dose combinations, an emerging concept to complement combination therapy, and (connected) on-body delivery systems, an identified future opportunity to support dosing outside of a controlled healthcare institutional environment. EXPERT OPINION: Leveraging existing synergies and learnings from other disease areas is a measure to reduce associated development and commercialization costs and thus to provide sustainable product offerings already at the initial launch of a medication.


Sujet(s)
Anticorps monoclonaux , COVID-19 , Humains , Anticorps monoclonaux/usage thérapeutique , Prestations des soins de santé , Préparation de médicament , Tissu sous-cutané
11.
J Rheumatol ; 50(3): 390-399, 2023 03.
Article de Anglais | MEDLINE | ID: mdl-36243417

RÉSUMÉ

OBJECTIVE: To develop Canadian recommendations for the screening, monitoring, and treatment of uveitis associated with juvenile idiopathic arthritis (JIA). METHODS: Recommendations were developed using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE)-ADOLOPMENT approach. A working group of 14 pediatric rheumatologists, 6 ophthalmologists, 2 methodologists, and 3 caregiver/patient representatives reviewed recent American College of Rheumatology (ACR)/Arthritis Foundation (AF) recommendations and worked in pairs to develop evidence-to-decision (EtD) tables. A survey to assess agreement and recommendations requiring group discussion was completed. EtD tables were presented, discussed, and voted upon at a virtual meeting, to produce the final recommendations. A health equity framework was applied to all aspects of the adolopment process including the EtD tables, survey responses, and virtual meeting discussion. RESULTS: The survey identified that 7 of the 19 recommendations required rigorous discussion. Seventy-five percent of working group members attended the virtual meeting to discuss controversial topics as they pertained to the Canadian environment, including timing to first eye exam, frequency of screening, escalation criteria for systemic and biologic therapy, and the role of nonbiologic therapies. Equity issues related to access to care and advanced therapeutics across Canadian provinces and territories were highlighted. Following the virtual meeting, 5 recommendations were adapted, 2 recommendations were removed, and 1 was developed de novo. CONCLUSION: Recommendations for JIA-associated uveitis were adapted to the Canadian context by a working group of pediatric rheumatologists, ophthalmologists with expertise in the management of uveitis, and parent/patient input, taking into consideration cost, equity, and access.


Sujet(s)
Arthrite juvénile , Rhumatologie , Uvéite , Enfant , Humains , Arthrite juvénile/diagnostic , Canada , Uvéite/complications
12.
J Clin Epidemiol ; 154: 146-155, 2023 02.
Article de Anglais | MEDLINE | ID: mdl-36584732

RÉSUMÉ

BACKGROUND AND OBJECTIVES: The World Health Organization Model List of Essential Medicines has led to at least 137 national lists. Essential medicines should be grounded in evidence-based guideline recommendations and explicit decision criteria. Essential medicines should be available, accessible, affordable, and the supporting evidence should be accompanied by a rating of the certainty one can place in it. Our objectives were to identify criteria and considerations that should be addressed in moving from a guideline recommendation regarding a medicine to the decision of whether to add, maintain, or remove a medicine from an essential medicines list. We also seek to explore opportunities to improve organizational processes to support evidence-based health decision-making more broadly. METHODS: We conducted a qualitative study with semistructured interviews of key informant stakeholders in the development and use of guidelines and essential medicine lists (EMLs). We used an interpretive descriptive analysis approach and thematic analysis of interview transcripts in NVIVO v12. RESULTS: We interviewed 16 key informants working at national and global levels across all WHO regions. We identified five themes: three descriptive/explanatory themes 1) EMLs and guidelines, the same, but different; 2) EMLs can drive price reductions and improve affordability and access; 3) Time lag and disconnect between guidelines and EMLs; and two prescriptive themes 4) An "evidence pipeline" could improve coordination between guidelines and EMLs; 5) Facilitating the link between the WHO Model List of Essential Medicines (WHO EML) and national EMLs could increase alignment. CONCLUSION: We found significant overlap and opportunities for alignment between guideline and essential medicine decision processes. This finding presents opportunities for guideline and EML developers to enhance strategies for collaboration. Future research should assess and evaluate these strategies in practice to support the shared goal of guidelines and EMLs: improvements in health.


Sujet(s)
Médicaments essentiels , Humains , Organisation mondiale de la santé , Recherche qualitative , Prévision
13.
J Clin Endocrinol Metab ; 108(3): 507-528, 2023 02 15.
Article de Anglais | MEDLINE | ID: mdl-36545746

RÉSUMÉ

BACKGROUND: Hypercalcemia of malignancy (HCM) is the most common metabolic complication of malignancies, but its incidence may be declining due to potent chemotherapeutic agents. The high mortality associated with HCM has declined markedly due to the introduction of increasingly effective chemotherapeutic drugs. Despite the widespread availability of efficacious medications to treat HCM, evidence-based recommendations to manage this debilitating condition are lacking. OBJECTIVE: To develop guidelines for the treatment of adults with HCM. METHODS: A multidisciplinary panel of clinical experts, together with experts in systematic literature review, identified and prioritized 8 clinical questions related to the treatment of HCM in adult patients. The systematic reviews (SRs) queried electronic databases for studies relevant to the selected questions. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology was used to assess the certainty of evidence and make recommendations. An independent SR was conducted in parallel to assess patients' and physicians' values and preferences, costs, resources needed, acceptability, feasibility, equity, and other domains relevant to the Evidence-to-Decision framework as well as to enable judgements and recommendations. RESULTS: The panel recommends (strong recommendation) in adults with HCM treatment with denosumab (Dmab) or an intravenous (IV) bisphosphonate (BP). The following recommendations were based on low certainty of the evidence. The panel suggests (conditional recommendation) (1) in adults with HCM, the use of Dmab rather than an IV BP; (2) in adults with severe HCM, a combination of calcitonin and an IV BP or Dmab therapy as initial treatment; and (3) in adults with refractory/recurrent HCM despite treatment with BP, the use of Dmab. The panel suggests (conditional recommendation) the addition of an IV BP or Dmab in adult patients with hypercalcemia due to tumors associated with high calcitriol levels who are already receiving glucocorticoid therapy but continue to have severe or symptomatic HCM. The panel suggests (conditional recommendation) in adult patients with hypercalcemia due to parathyroid carcinoma, treatment with either a calcimimetic or an antiresorptive (IV BP or Dmab). The panel judges the treatments as probably accessible and feasible for most recommendations but noted variability in costs, resources required, and their impact on equity. CONCLUSIONS: The panel's recommendations are based on currently available evidence considering the most important outcomes in HCM to patients and key stakeholders. Treatment of the primary malignancy is instrumental for controlling hypercalcemia and preventing its recurrence. The recommendations provide a framework for the medical management of adults with HCM and incorporate important decisional and contextual factors. The guidelines underscore current knowledge gaps that can be used to establish future research agendas.


Sujet(s)
Agents de maintien de la densité osseuse , Hypercalcémie , Tumeurs , Humains , Adulte , Hypercalcémie/traitement médicamenteux , Hypercalcémie/étiologie , Tumeurs/complications , Agents de maintien de la densité osseuse/usage thérapeutique , Diphosphonates/usage thérapeutique
14.
Health Res Policy Syst ; 20(1): 125, 2022 Nov 07.
Article de Anglais | MEDLINE | ID: mdl-36344986

RÉSUMÉ

BACKGROUND: In 2019, WHO prioritized updating recommendations relating to three labour induction topics: labour induction at or beyond term, mechanical methods for labour induction, and outpatient labour induction. As part of this process, we aimed to review the evidence addressing factors beyond clinical effectiveness (values, human rights and sociocultural acceptability, health equity, and economic and feasibility considerations) to inform WHO Guideline Development Group decision-making using the WHO-INTEGRATE evidence-to-decision framework, and to reflect on how methods for identifying, synthesizing and integrating this evidence could be improved. METHODS: We adapted the framework to consider the key criteria and sub-criteria relevant to our intervention. We searched for qualitative and other evidence across a variety of sources and mapped the eligible evidence to country income setting and perspective. Eligibility assessment and quality appraisal of qualitative evidence syntheses was undertaken using a two-step process informed by the ENTREQ statement. We adopted an iterative approach to interpret the evidence and provided both summary and detailed findings to the decision-makers. We also undertook a review to reflect on opportunities to improve the process of applying the framework and identifying the evidence. RESULTS: Using the WHO-INTEGRATE framework allowed us to explore health rights and equity in a systematic and transparent way. We identified a lack of qualitative and other evidence from low- and middle-income settings and in populations that are most impacted by structural inequities or traditionally excluded from research. Our process review highlighted opportunities for future improvement, including adopting more systematic evidence mapping methods and working with social science researchers to strengthen theoretical understanding, methods and interpretation of the evidence. CONCLUSIONS: Using the WHO-INTEGRATE evidence-to-decision framework to inform decision-making in a global guideline for induction of labour, we identified both challenges and opportunities relating to the lack of evidence in populations and settings of need and interest; the theoretical approach informing the development and application of WHO-INTEGRATE; and interpretation of the evidence. We hope these insights will be useful for primary researchers as well as the evidence synthesis and health decision-making communities, and ultimately contribute to a reduction in health inequities.


Sujet(s)
Médecine factuelle , Accessibilité des services de santé , Humains , Femelle , Grossesse , Droits de l'homme , Organisation mondiale de la santé , Accouchement provoqué
15.
J Comp Eff Res ; 2022 Sep 12.
Article de Anglais | MEDLINE | ID: mdl-36093741

RÉSUMÉ

Aim: Technical Support Document 21 discusses trial-based, flexible relative survival models. The authors generalized flexible relative survival models to the network meta-analysis (NMA) setting while accounting for different treatment-effect specifications. Methods: The authors compared the standard parametric model with mixture, mixture cure and nonmixture cure, piecewise, splines and fractional polynomial models. The optimal treatment-effect parametrization was defined in two steps. First, all models were run with treatment effects on all parameters and subsequently the optimal model was defined by removing uncertain treatment effects, for which the parameter was smaller than its standard deviation. The authors used a network in previously treated advanced non-small-cell lung cancer. Results: Flexible model-based NMAs impact fit and incremental mean survival and they increase corresponding uncertainty. Treatment-effect specification impacts incremental survival, reduces uncertainty and improves the fit statistic. Conclusion: Extrapolation techniques already available for individual trials can now be used for NMAs to ensure that the most plausible extrapolations are being used for health technology assessment submissions.

16.
J Clin Epidemiol ; 150: 51-62, 2022 10.
Article de Anglais | MEDLINE | ID: mdl-35710054

RÉSUMÉ

OBJECTIVE: The aim of this study is to identify and describe the processes suggested for the formulation of healthcare recommendations in healthcare guidelines available in guidance documents. METHODS: We searched international databases in May 2020 to retrieve guidance documents published by organizations dedicated to guideline development. Pairs of researchers independently selected and extracted data about the characteristics of the guidance document, including explicit or implicit recommendation-related criteria and processes considered, as well as the use of evidence to decision (EtD) frameworks. RESULTS: We included 68 guidance documents. Most organizations reported a system for grading the strength of recommendations (88%), half of them being the GRADE (Grading of Recommendations Assessment, Development, and Evaluation) approach. Two out of three guidance documents (66%) proposed the use of a framework to guide the EtD process. The GRADE-EtD framework was the most often reported framework (19 organizations, 42%), whereas 20 organizations (44%) proposed their own multicriteria frameworks. Using any EtD framework was related with a more comprehensive set of recommendation-related criteria compared to no framework, especially for criteria like values, equity, and acceptability. CONCLUSION: Although limited, the use of EtD frameworks was associated with the inclusion of relevant recommendation criteria. Among the EtD structured frameworks, the GRADE-EtD framework offers the most comprehensive perspective for evidence-informed decision-making processes.


Sujet(s)
Prise de décision , Médecine factuelle , Humains , Prestations des soins de santé
17.
Eur J Vasc Endovasc Surg ; 63(6): 791-799, 2022 06.
Article de Anglais | MEDLINE | ID: mdl-35697645

RÉSUMÉ

OBJECTIVE: A structured and transparent approach is instrumental in translating research evidence to health recommendations and evidence informed clinical decisions. The aim was to conduct an overview and analysis of principles and methodologies for health guideline development. METHODS: A literature review on methodologies, strategies, and fundamental steps in the process of guideline development was performed. The clinical practice guideline development process and methodology adopted by the European Society for Vascular Surgery are also presented. RESULTS: Sophisticated methodologies for health guideline development are being applied increasingly by national and international organisations. Their overarching principle is a systematic, structured, transparent, and iterative process that is aimed at making well informed healthcare choices. Critical steps in guideline development include the assessment of the certainty of the body of evidence; evidence to decision frameworks; and guideline reporting. The goal of strength of evidence assessments is to provide well reasoned judgements about the guideline developers' confidence in study findings, and several evidence hierarchy schemes and evidence rating systems have been described for this purpose. Evidence to decision frameworks help guideline developers and users conceptualise and interpret the construct of the quality of the body of evidence. The most widely used evidence to decision frameworks are those developed by the GRADE Working Group and the WHO-INTEGRATE, and are structured into three distinct components: background; assessment; and conclusions. Health guideline reporting tools are employed to ensure methodological rigour and transparency in guideline development. Such reporting instruments include the AGREE II and RIGHT, with the former being used for guideline development and appraisal, as well as reporting. CONCLUSION: This guide will help guideline developers/expert panels enhance their methodology, and patients/clinicians/policymakers interpret guideline recommendations and put them in context. This document may be a useful methodological summary for health guideline development by other societies and organisations.

18.
Comput Ind Eng ; 169: 108207, 2022 Jul.
Article de Anglais | MEDLINE | ID: mdl-35529174

RÉSUMÉ

At the beginning of 2020, the World Health Organization (WHO) identified an unusual coronavirus and declared the associated COVID-19 disease as a global pandemic. We proposed a novel hybrid fuzzy decision-making framework to identify and analyze these transmission factors and conduct proactive decision-making in this context. We identified thirty factors from the extant literature and classified them into six major clusters (climate, hygiene and safety, responsiveness to decision-making, social and demographic, economic, and psychological) with the help of domain experts. We chose the most relevant twenty-five factors using the Fuzzy Delphi Method (FDM) screening from the initial thirty. We computed the weights of those clusters and their constituting factors and ranked them based on their criticality, applying the Fuzzy Analytic Hierarchy Process (FAHP). We found that the top five factors were global travel, delay in travel restriction, close contact, social cohesiveness, and asymptomatic. To evaluate our framework, we chose ten different geographically located cities and analyzed their exposure to COVID-19 pandemic by ranking them based on their vulnerability of transmission using Fuzzy Technique for Order of Preference by Similarity To Ideal Solution (FTOPSIS). Our study contributes to the disciplines of decision analytics and healthcare risk management during a pandemic through these novel findings. Policymakers and healthcare officials will benefit from our study by formulating and improving existing preventive measures to mitigate future global pandemics. Finally, we performed a sequence of sensitivity analyses to check for the robustness and generalizability of our proposed hybrid decision-making framework.

19.
Adv Stat Anal ; 106(3): 349-382, 2022.
Article de Anglais | MEDLINE | ID: mdl-35432617

RÉSUMÉ

A pandemic poses particular challenges to decision-making because of the need to continuously adapt decisions to rapidly changing evidence and available data. For example, which countermeasures are appropriate at a particular stage of the pandemic? How can the severity of the pandemic be measured? What is the effect of vaccination in the population and which groups should be vaccinated first? The process of decision-making starts with data collection and modeling and continues to the dissemination of results and the subsequent decisions taken. The goal of this paper is to give an overview of this process and to provide recommendations for the different steps from a statistical perspective. In particular, we discuss a range of modeling techniques including mathematical, statistical and decision-analytic models along with their applications in the COVID-19 context. With this overview, we aim to foster the understanding of the goals of these modeling approaches and the specific data requirements that are essential for the interpretation of results and for successful interdisciplinary collaborations. A special focus is on the role played by data in these different models, and we incorporate into the discussion the importance of statistical literacy and of effective dissemination and communication of findings.

20.
J Hazard Mater ; 429: 128330, 2022 05 05.
Article de Anglais | MEDLINE | ID: mdl-35121294

RÉSUMÉ

Plastics are an intrinsic part of modern life with many beneficial uses for society. Yet, there is increasing evidence that plastic and microplastic pollution poses a risk to the environment and human health. Microplastics are increasingly grouped as a complex mix of polymers with different physicochemical and toxicological properties. This study attempts to assess the hazardous properties of common polymer types through the development of an integrated multi-criteria framework. The framework establishes a systematic approach to identify plastic polymers of concern. A semi-quantitative method was devised using twenty-one criteria. We used a case study from Victoria, Australia, to evaluate the effectiveness of the framework to characterize the environmental risk of common polymer types. A wide range of data sources were interrogated to complete an in-depth analysis across the material life cycle. We found that three polymers had the highest risk of harm: polyvinyl chloride, polypropylene, and polystyrene; with dominant sectors being: building and construction, packaging, consumer and household, and automotive sectors; and greatest leakage of plastics at the end-of-life stages. Our findings illustrate the complexity of microplastics as an emerging contaminant, and its scalability supports decision-makers globally to identify and prioritize management strategies to address the risks posed by plastics. ENVIRONMENTAL IMPLICATION: The hazardous nature of mismanaged plastics is an international concern. The negative impacts on the environment and human health are increasingly coming to light. Consequently, resource constraints limits the ability to address all problems. Our work adopts a holistic approach to evaluate the risk of harm from microplastics across the entire life cycle to allow for targeted management measures. The hazard assessment of common polymer types developed using a multi-criteria framework, presents a systematic approach to prioritize polymers at any scale. This allows for the development of optimal investments and interventions to ensure that high-risk environmental problems are addressed first.


Sujet(s)
Matières plastiques , Polluants chimiques de l'eau , Australie , Surveillance de l'environnement , Pollution de l'environnement , Humains , Microplastiques/toxicité , Matières plastiques/analyse , Polymères , Polluants chimiques de l'eau/analyse , Polluants chimiques de l'eau/toxicité
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