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1.
J Hypertens ; 42(6): 939-947, 2024 Jun 01.
Artigo em Inglês | MEDLINE | ID: mdl-38647124

RESUMO

Recent evidence suggests that an exaggerated blood pressure (BP) response to standing (ERTS) is associated with an increased risk of adverse outcomes, both in young and old individuals. In addition, ERTS has been shown to be an independent predictor of masked hypertension. In the vast majority of studies reporting on the prognostic value of orthostatic hypertension (OHT), the definition was based only on systolic office BP measurements. This consensus statement provides recommendations on the assessment and management of individuals with ERTS and/or OHT. ERTS is defined as an orthostatic increase in SBP at least 20 mmHg and OHT as an ERTS with standing SBP at least 140 mmHg. This statement recommends a standardized methodology to assess ERTS, by considering body and arm position, and the number and timing of BP measurements. ERTS/OHT should be confirmed in a second visit, to account for its limited reproducibility. The second assessment should evaluate BP changes from the supine to the standing posture. Ambulatory BP monitoring is recommended in most individuals with ERTS/OHT, especially if they have high-normal seated office BP. Implementation of lifestyle changes and close follow-up are recommended in individuals with ERTS/OHT and normotensive seated office BP. Whether antihypertensive treatment should be administered in the latter is unknown. Hypertensive patients with ERTS/OHT should be managed as any other hypertensive patient. Standardized standing BP measurement should be implemented in future epidemiological and interventional studies.


Assuntos
Pressão Sanguínea , Hipertensão , Humanos , Hipertensão/fisiopatologia , Hipertensão/diagnóstico , Hipertensão/terapia , Pressão Sanguínea/fisiologia , Determinação da Pressão Arterial/métodos , Consenso , Posição Ortostática , Europa (Continente) , Monitorização Ambulatorial da Pressão Arterial/métodos
2.
PLoS One ; 19(4): e0299688, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38635645

RESUMO

With the world population growth, energy consumption and the rapid development of industrial economy, a large amount of carbon emissions has brought destruction and threats to the earth's environment on which human beings depend. The development of low-carbon economy has become the consensus of governments all over the world and has been vigorously advocated & promoted. This paper focuses on the top five global GDP nations in 2022: The United States, China, Japan, Germany, and Britain. A comprehensive evaluation index system of urban low-carbon economic development level is constructed from four dimensions: economic development level, environmental quality, energy consumption emission intensity and social development speed by using literature review and field interview. The evaluation measures are determined using the TOPSIS evaluation method with entropy weight and the grey relational model, providing a comprehensive assessment of the low-carbon economy's development level in these five countries." Judging from the comprehensive evaluation score, the overall development of low-carbon economy in American cities is in good condition and has reached the development standard of low-carbon economy; Germany and Japan rank second and third, and they are low-carbon economies. Britain ranks fourth in comprehensive evaluation, although it belongs to a low-carbon economy country, but there is still a certain gap with Germany and Japan; There is still a big gap between China and the other four countries. Based on the measurement and evaluation outcomes, it presents recommendations and strategies to foster the growth of low-carbon economies, offering valuable insights for the advancement of such economies across different nations. The research results guide countries all over the world to reduce carbon emissions in the process of economic development, protect the earth environment on which human beings depend, and make a better tomorrow for sustainable development.


Assuntos
Carbono , Desenvolvimento Econômico , Humanos , China , Cidades , Consenso , Dióxido de Carbono
3.
Curr Oncol ; 31(4): 1803-1816, 2024 Mar 29.
Artigo em Inglês | MEDLINE | ID: mdl-38668039

RESUMO

Patient access to new oncology drugs in Canada is only possible after navigating multiple sequential systemic checkpoints for national regulatory approval, health technology assessment (HTA) and collective government price negotiation. These steps delay access and prevent health care providers from being able to prescribe optimal therapy. Eighteen Canadian oncology clinicians from the medicine, nursing and pharmacy professions met to develop consensus recommendations for defining reasonable government performance standards around process and timeliness to improve Canadian cancer patients' access to best care. A modified Delphi methodology was used to identify consensus on 30 questions involving five themes: accountability, disparities, endpoints, timeliness, and cost-effectiveness. It was agreed that greater transparency is required across regulatory and HTA processes. Health professionals in oncology are frustrated for their patients because they are unable to deliver the modern guideline-supported therapies they want to provide due to delays in approval or funding. Canadian health care providers request improvements in timely access to life-saving therapeutics in line with other comparator countries. Clinicians expect urgent improvements in Canadian health systems to give our patients their best chance of survival.


Assuntos
Acessibilidade aos Serviços de Saúde , Humanos , Canadá , Antineoplásicos/uso terapêutico , Consenso , Oncologia/normas , Neoplasias/tratamento farmacológico
4.
Curr Oncol ; 31(4): 1876-1898, 2024 Apr 01.
Artigo em Inglês | MEDLINE | ID: mdl-38668044

RESUMO

Multi-criteria decision analysis (MCDA) is a value assessment tool designed to help support complex decision-making by incorporating multiple factors and perspectives in a transparent, structured approach. We developed an MCDA rating tool, consisting of seven criteria evaluating the importance and feasibility of conducting potential real-world evidence (RWE) studies aimed at addressing uncertainties stemming from initial cancer drug funding recommendations. In collaboration with the Canadian Agency for Drugs and Technologies in Health's Provincial Advisory Group, a validation exercise was conducted to further evaluate the application of the rating tool using RWE proposals varying in complexity. Through this exercise, we aimed to gain insight into consensus building and deliberation processes and to identify efficiencies in the application of the rating tool. An experienced facilitator led a multidisciplinary committee, consisting of 11 Canadian experts, through consensus building, deliberation, and prioritization. A total of nine RWE proposals were evaluated and prioritized as low (n = 4), medium (n = 3), or high (n = 2) priority. Through an iterative process, efficiencies and recommendations to improve the rating tool and associated procedures were identified. The refined MCDA rating tool can help decision-makers prioritize important and feasible RWE studies for research and can enable the use of RWE for the life-cycle evaluation of cancer drugs.


Assuntos
Antineoplásicos , Técnicas de Apoio para a Decisão , Humanos , Canadá , Antineoplásicos/uso terapêutico , Neoplasias/tratamento farmacológico , Avaliação da Tecnologia Biomédica/métodos , Consenso
5.
J Healthc Qual Res ; 39(3): 188-194, 2024.
Artigo em Espanhol | MEDLINE | ID: mdl-38614936

RESUMO

INTRODUCTION: Mechanical restraints are widely used in health care practice, despite the numerous ethical conflicts they raise. The aim of this study is to evaluate the ethical considerations contemplated in the current protocols on mechanical restraint in Spain. METHOD: Systematic review in PubMed, WOS and Scopus, Google and Google Scholar. An ad hoc list of 30 items was used to evaluate the ethical content of the protocols. The quality of guidelines was assessed with AGREE II. RESULTS: The need for informed consent (IC) is reflected in 72% of the documents, the IC model sheet is included in only 41% of them, the rest of the analyzed characteristics on IC are fulfilled in percentages between 6% (the document includes the need to reevaluate the indication for IC) and 31% (the document contemplates to whom it should be requested). More than 20 ethical contents are reflected in 31% of them and less than 10 in 19% of the guidelines. The quality of the guides, according to AGREE II, ranged from 27 to 116 points (maximum possible 161), with a mean score of 68.7. Only 9% of the documents were classified as high quality. Finally, the correlation between ethical content and quality measured with AGREE II was 0.75. CONCLUSIONS: The variability of ethical contents in guidelines on mechanical restraints is very high. The ethical requirements to be included in protocols, consensus or Clinical Practice Guidelines should be defined.


Assuntos
Restrição Física , Espanha , Humanos , Restrição Física/ética , Consentimento Livre e Esclarecido/ética , Consenso , Guias de Prática Clínica como Assunto , Protocolos Clínicos/normas
7.
PLoS One ; 19(4): e0297799, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38626051

RESUMO

Annually, about 300 million surgeries lead to significant intraoperative adverse events (iAEs), impacting patients and surgeons. Their full extent is underestimated due to flawed assessment and reporting methods. Inconsistent adoption of new grading systems and a lack of standardization, along with litigation concerns, contribute to underreporting. Only half of relevant journals provide guidelines on reporting these events, with a lack of standards in surgical literature. To address these issues, the Intraoperative Complications Assessment and Reporting with Universal Standard (ICARUS) Global Surgical Collaboration was established in 2022. The initiative involves conducting global surveys and a Delphi consensus to understand the barriers for poor reporting of iAEs, validate shared criteria for reporting, define iAEs according to surgical procedures, evaluate the existing grading systems' reliability, and identify strategies for enhancing the collection, reporting, and management of iAEs. Invitation to participate are extended to all the surgical specialties, interventional cardiology, interventional radiology, OR Staffs and anesthesiology. This effort represents an essential step towards improved patient safety and the well-being of healthcare professionals in the surgical field.


Assuntos
Especialidades Cirúrgicas , Cirurgiões , Humanos , Consenso , Reprodutibilidade dos Testes , Complicações Intraoperatórias/diagnóstico
9.
Gastroenterol Nurs ; 47(2): 92-100, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38567852

RESUMO

This study aims to develop and validate a nursing assessment tool for patients with inflammatory bowel disease. In this cross-sectional descriptive study using a quantitative approach, nurses were invited to participate. The Delphi technique was used to obtain a consensus among expert nurses. Descriptive analysis was used for each item on the nursing assessment tool. Overall, 345 nurses were identified; 32 were eligible as experts and 13 validated the consultation. Of the 13 expert nurses, most were female (11, 84.62%), their mean age was 46.36 ± 10.59 years, eight (61.54%) graduated from public institutions, and eight (61.54%) had a master's degree. The initial version had 106 items, which was reduced to 95 items. The content of four domains (identification, health-disease profile, psychobiological needs, and physical examination) was validated in two rounds about the content with more than 80% of agreement. Two domains (sociodemographic data and health conditions, and personal cares) were validated in the first round with more than 80% of agreement. All domains were validated for their appearance during the first round with more than 80% of agreement. The Nursing Assessment Tool for Patients with Inflammatory Bowel Disease (IBD) had a considerable level of agreement regarding content and appearance validation in all dimensions.


Assuntos
Doenças Inflamatórias Intestinais , Humanos , Feminino , Adulto , Pessoa de Meia-Idade , Masculino , Estudos Transversais , Técnica Delphi , Inquéritos e Questionários , Doenças Inflamatórias Intestinais/diagnóstico , Consenso
10.
Pediatrics ; 153(5)2024 May 01.
Artigo em Inglês | MEDLINE | ID: mdl-38596852

RESUMO

Individuals with a neurodevelopmental disability (NDD) face significant health care barriers, disparities in health outcomes, and high rates of foregone and adverse health care experiences. The Supporting Access for Everyone (SAFE) Initiative was developed to establish principles of health care to improve equity for youth with NDDs through an evidence-informed and consensus-derived process. With the Developmental Behavioral Pediatric Research Network, the SAFE cochairs convened a consensus panel composed of diverse professionals, caregivers, and adults with NDDs who contributed their varied expertise related to SAFE care delivery. A 2-day public forum (attended by consensus panel members) was convened where professionals, community advocates, and adults with NDDs and/or caregivers of individuals with NDDs presented research, clinical strategies, and personal experiences. After this, a 2-day consensus conference was held. Using nominal group technique, the panel derived a consensus statement (CS) on SAFE care, an NDD Health Care Bill of Rights, and Transition Considerations. Ten CSs across 5 topical domains were established: (1) training, (2) communication, (3) access and planning, (4) diversity, equity, inclusion, belonging, and anti-ableism, and (5) policy and structural change. Relevant and representative citations were added when available to support the derived statements. The final CS was approved by all consensus panel members and the Developmental Behavioral Pediatric Research Network steering committee. At the heart of this CS is an affirmation that all people are entitled to health care that is accessible, humane, and effective.


Assuntos
Acessibilidade aos Serviços de Saúde , Transtornos do Neurodesenvolvimento , Humanos , Transtornos do Neurodesenvolvimento/terapia , Criança , Adolescente , Consenso
11.
Zhonghua Yi Xue Za Zhi ; 104(12): 893-905, 2024 Mar 26.
Artigo em Chinês | MEDLINE | ID: mdl-38514338

RESUMO

Mobility limitation is an age-related geriatric syndrome that is affected by multiple factors such as aging, multimorbidity, nutritional status, chronic pain, psychological and social factors, which increases the risk of adverse events such as pressure ulcers, venous thrombosis, constipation, frailty, disability, falls and death in older adults. Early identification of mobility limitation and individualized comprehensive management are of great significance to maintain the functional status and quality of life of older adults. However, the understanding of the importance of mobility limitation prevention and treatment in older adults is insufficient, and there is a lack of standardized diagnosis and treatment standards for mobility limitation. Based on evidence-based medicine, this consensus expert group integrated the latest research progress, guidelines and consensus recommendations on mobility limitation and proposed 20 recommendations containing screening, assessment, intervention and comprehensive management, emphasizing the multidisciplinary decision-making model of "screening-comprehensive assessment-multiple interventions-joint management". We aimed to provide guidance and suggestions for the standardized management of mobility limitation in older adults.


Assuntos
Avaliação Geriátrica , Qualidade de Vida , Humanos , Idoso , Limitação da Mobilidade , Consenso , China
12.
Neural Netw ; 174: 106261, 2024 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-38521018

RESUMO

This study presents a solution to the challenges of tracking consensus and guarantee-cost H∞ control in a specific set of second-order multi-agent systems with external disturbances. A proposed event-triggered control method based on periodic sampling data is presented for second-order multi-agent systems that include external disturbances. In contrast to the real-time monitoring of system state information used in the previous event-triggered mechanism, this approach collects system state information through periodic sampling. This ensures that the interval between two consecutive triggering moments is at least one sampling cycle, thereby preventing the controller from triggering infinitely within a finite time frame. A finite-time controller based on the sampled-data event-triggered mechanism is designed, and sufficient conditions to ensure the finite-time stability of the closed-loop system at a specified attenuation level are established using theoretical methods such as matrix analysis. For the given sampled-data event-triggered control protocol with a finite-time controller, a quadratic guarantee-cost function is introduced, and by designing control inputs and determining the parameters such as the finite-time upper bound T∗ and the H∞ performance index γ , the exact value of the upper bound of the system's guarantee-cost function under the action of the designed controller is derived. Finally, the feasibility of the proposed control scheme is verified through numerical simulation.


Assuntos
Consenso , Simulação por Computador
13.
BMJ Open ; 14(3): e078479, 2024 Mar 08.
Artigo em Inglês | MEDLINE | ID: mdl-38458780

RESUMO

INTRODUCTION: Community-based participatory research (CBPR) is a collaborative research approach that equally engages researchers and community stakeholders throughout all steps of the research process to facilitate social change and increase research relevance. Community advisory boards (CABs) are a CBPR tool in which individuals with lived experience and community organisations are integrated into the research process and ensure the work aligns with community priorities. We seek to (1) explore the best practices for the recruitment and engagement of people with lived experiences on CABs and (2) identify the scope of literature on minimising power dynamics between organisations and community members with lived experience who work on CABs together. METHODS AND ANALYSIS: This scoping review will follow the Arksey and O'Malley methodological framework, informed by Levac et al, and will be reported using a PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) diagram. Detailed and robust search strategies have been developed for Embase, Medline and PsychINFO. Grey literature references and reference lists of included articles published between 1 January 1990 and 30 March 2023 will be considered. Two reviewers will independently screen references in two successive stages of title/abstract and full-text screening. Conflicts will be decided by consensus or a third reviewer. Thematic analysis will be applied in three phases: open coding, axial coding and abstraction. Extracted data will be recorded and presented in a tabular format and/or graphical summaries, with a descriptive overview discussing how the research findings relate to the research questions. At this time, a preliminary search of peer-reviewed and grey literature has been conducted. Search results for peer-reviewed literature have been uploaded to Covidence for review and appraisal for relevance. ETHICS AND DISSEMINATION: Formal ethics approval is not required for this review. Review findings will inform ongoing and future CBPR community advisory board dynamics. REGISTRATION: The protocol has been registered prospectively on the Open Science Framework (https://doi.org/10.17605/OSF.IO/QF5D3).


Assuntos
Pesquisa Participativa Baseada na Comunidade , Formação de Conceito , Humanos , Consenso , Literatura Cinzenta , MEDLINE , Projetos de Pesquisa , Literatura de Revisão como Assunto
14.
PLoS One ; 19(3): e0301273, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38547231

RESUMO

This paper presents a custom made small rover based surveying, mapping and building information modeling solution. Majority of the commercially available mobile surveying systems are larger in size which restricts their maneuverability in the targeted indoor vicinities. Furthermore their functional cost is unaffordable for low budget projects belonging to developing markets. Keeping in view these challenges, an economical indigenous rover based scanning and mapping system has developed using orthogonal integration of two low cost RPLidar A1 laser scanners. All the instrumentation of the rover has been interfaced with Robot Operating System (ROS) for online processing and recording of all sensorial data. The ROS based pose and map estimations of the rover have performed using Simultaneous Localization and Mapping (SLAM) technique. The perceived class 1 laser scans data belonging to distinct vicinities with variable reflective properties have been successfully tested and validated for required structural modeling. Systematically the recorded scans have been used in offline mode to generate the 3D point cloud map of the surveyed environment. Later the structural planes extraction from the point cloud data has been done using Random Sampling and Consensus (RANSAC) technique. Finally the 2D floor plan and 3D building model have been developed using point cloud processing in appropriate software. Multiple interiors of existing buildings and under construction indoor sites have been scanned, mapped and modelled as presented in this paper. In addition, the validation of the as-built models have been performed by comparing with the actual architecture design of the surveyed buildings. In comparison to available surveying solutions present in the local market, the developed system has been found faster, accurate and user friendly to produce more enhanced structural results with minute details.


Assuntos
Orçamentos , Computação em Nuvem , Espécies Reativas de Oxigênio , Consenso , Lasers
15.
PLoS One ; 19(3): e0294393, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38446765

RESUMO

OBJECTIVE: Complementary Health Approaches (CHA) are commonly used by children with cancer; however, a few health care providers (HCPs) inquire about the use of CHA. A standardized questionnaire could facilitate such clinical discussions. We aimed to adapt and determine the face and content validity of the "Which Health Approaches and Treatments are you using?" (WHAT) child and parent-report questionnaires in pediatric oncology. METHODS: An electronic Delphi survey that included children with cancer (8-18 years), parents, and HCPs and CHA researchers was conducted to reach consensus on the content of the WHAT questionnaires in pediatric oncology. Children and parents from the Hospital for Sick Children (SickKids), and HCPs and researchers from the International Society of Pediatric Oncology and Pediatric Complementary and Alternative Medicine Research and Education Network completed the survey. To determine the face and content validity of the questionnaires, two iterative cycles of individual interviews were conducted with purposive samples of children (8-18 years), parents, and HCPs from SickKids. RESULTS: Consensus was reached on all domains and items of the original WHAT questionnaires after one Delphi cycle (n = 61). For face and content validity testing, the first cycle of interviews (n = 19) revealed that the questionnaires were mostly comprehensive and relevant. However, the paper-based format of the original WHAT was not user-friendly, and generic items were vague and not aimed at facilitating clinical dialogues about CHA use. The WHAT questionnaires were then modified into electronic cancer-specific self- and proxy-report questionnaires including 13 and 15 items, respectively. The second cycle (n = 21) showed no need for further changes. CONCLUSIONS: The modified electronic cancer-specific WHAT questionnaires showed adequate face and content validity. The next step is to determine inter-rater reliability, construct validity, and feasibility of administration of the modified WHAT questionnaires in pediatric oncology.


Assuntos
Oncologia , Neoplasias , Criança , Humanos , Reprodutibilidade dos Testes , Diretivas Antecipadas , Consenso , Neoplasias/diagnóstico , Neoplasias/terapia
16.
Br J Psychiatry ; 224(4): 115-116, 2024 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-38470301

RESUMO

The enormous impact of mental illness on work and productivity is a global challenge, with immense costs to wider society. Now is the time for action, with new international guidelines and an emergent consensus on occupational mental healthcare. Alongside governments, organisations and employers, psychiatrists have a leading role to play.


Assuntos
Transtornos Mentais , Saúde Mental , Humanos , Transtornos Mentais/epidemiologia , Transtornos Mentais/terapia , Consenso , Psiquiatras
17.
Curr Sports Med Rep ; 23(3): 86-104, 2024 Mar 01.
Artigo em Inglês | MEDLINE | ID: mdl-38437494

RESUMO

ABSTRACT: Musculoskeletal injuries occur frequently in sport during practice, training, and competition. Injury assessment and management are common responsibilities for the team physician. Initial Assessment and Management of Musculoskeletal Injury-A Team Physician Consensus Statement is title 23 in a series of annual consensus documents written for the practicing team physician. This statement was developed by the Team Physician Consensus Conference, an annual project-based alliance of six major professional associations. The goal of this document is to help the team physician improve the care and treatment of the athlete by understanding the initial assessment and management of selected musculoskeletal injuries.


Assuntos
Médicos , Esportes , Humanos , Atletas , Consenso , Exame Físico
18.
Curr Protoc ; 4(3): e977, 2024 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-38441413

RESUMO

Health disparities are driven by unequal conditions in the environments in which people are born, live, learn, work, play, worship, and age, commonly termed the Social Determinants of Health (SDoH). The availability of recommended measurement protocols for SDoH will enable investigators to consistently collect data for SDoH constructs. The PhenX (consensus measures for Phenotypes and eXposures) Toolkit is a web-based catalog of recommended measurement protocols for use in research studies with human participants. Using standard protocols from the PhenX Toolkit makes it easier to compare and combine studies, potentially increasing the impact of individual studies, and aids in comparability across literature. In 2018, the National Institute on Minority Health and Health Disparities provided support for an initial expert Working Group to identify and recommend established SDoH protocols for inclusion in the PhenX Toolkit. In 2022, a second expert Working Group was convened to build on the work of the first SDoH Working Group and address gaps in the SDoH Toolkit Collections. The SDoH Collections consist of a Core Collection and Individual and Structural Specialty Collections. This article describes a Basic Protocol for using the PhenX Toolkit to select and implement SDoH measurement protocols for use in research studies. © 2024 The Authors. Current Protocols published by Wiley Periodicals LLC. This article has been contributed to by U.S. Government employees and their work is in the public domain in the USA. Basic Protocol: Using the PhenX Toolkit to select and implement SDoH protocols.


Assuntos
Academias e Institutos , Determinantes Sociais da Saúde , Humanos , Consenso , Estudos Epidemiológicos , Empregados do Governo
19.
Int J Oral Sci ; 16(1): 22, 2024 Mar 01.
Artigo em Inglês | MEDLINE | ID: mdl-38429281

RESUMO

Endodontic diseases are a kind of chronic infectious oral disease. Common endodontic treatment concepts are based on the removal of inflamed or necrotic pulp tissue and the replacement by gutta-percha. However, it is very essential for endodontic treatment to debride the root canal system and prevent the root canal system from bacterial reinfection after root canal therapy (RCT). Recent research, encompassing bacterial etiology and advanced imaging techniques, contributes to our understanding of the root canal system's anatomy intricacies and the technique sensitivity of RCT. Success in RCT hinges on factors like patients, infection severity, root canal anatomy, and treatment techniques. Therefore, improving disease management is a key issue to combat endodontic diseases and cure periapical lesions. The clinical difficulty assessment system of RCT is established based on patient conditions, tooth conditions, root canal configuration, and root canal needing retreatment, and emphasizes pre-treatment risk assessment for optimal outcomes. The findings suggest that the presence of risk factors may correlate with the challenge of achieving the high standard required for RCT. These insights contribute not only to improve education but also aid practitioners in treatment planning and referral decision-making within the field of endodontics.


Assuntos
Materiais Restauradores do Canal Radicular , Tratamento do Canal Radicular , Humanos , Consenso , Tratamento do Canal Radicular/métodos , Guta-Percha/uso terapêutico , Necrose da Polpa Dentária/tratamento farmacológico , Retratamento , Cavidade Pulpar , Materiais Restauradores do Canal Radicular/uso terapêutico , Preparo de Canal Radicular
20.
BMC Med Res Methodol ; 24(1): 61, 2024 Mar 09.
Artigo em Inglês | MEDLINE | ID: mdl-38461273

RESUMO

BACKGROUND: The provision of data sharing statements (DSS) for clinical trials has been made mandatory by different stakeholders. DSS are a device to clarify whether there is intention to share individual participant data (IPD). What is missing is a detailed assessment of whether DSS are providing clear and understandable information about the conditions for data sharing of IPD for secondary use. METHODS: A random sample of 200 COVID-19 clinical trials with explicit DSS was drawn from the ECRIN clinical research metadata repository. The DSS were assessed and classified, by two experienced experts and one assessor with less experience in data sharing (DS), into different categories (unclear, no sharing, no plans, yes but vague, yes on request, yes with specified storage location, yes but with complex conditions). RESULTS: Between the two experts the agreement was moderate to substantial (kappa=0.62, 95% CI [0.55, 0.70]). Agreement considerably decreased when these experts were compared with a third person who was less experienced and trained in data sharing ("assessor") (kappa=0.33, 95% CI [0.25, 0.41]; 0.35, 95% CI [0.27, 0.43]). Between the two experts and under supervision of an independent moderator, a consensus was achieved for those cases, where both experts had disagreed, and the result was used as "gold standard" for further analysis. At least some degree of willingness of DS (data sharing) was expressed in 63.5% (127/200) cases. Of these cases, around one quarter (31/127) were vague statements of support for data sharing but without useful detail. In around half of the cases (60/127) it was stated that IPD could be obtained by request. Only in in slightly more than 10% of the cases (15/127) it was stated that the IPD would be transferred to a specific data repository. In the remaining cases (21/127), a more complex regime was described or referenced, which could not be allocated to one of the three previous groups. As a result of the consensus meetings, the classification system was updated. CONCLUSION: The study showed that the current DSS that imply possible data sharing are often not easy to interpret, even by relatively experienced staff. Machine based interpretation, which would be necessary for any practical application, is currently not possible. Machine learning and / or natural language processing techniques might improve machine actionability, but would represent a very substantial investment of research effort. The cheaper and easier option would be for data providers, data requestors, funders and platforms to adopt a clearer, more structured and more standardised approach to specifying, providing and collecting DSS. TRIAL REGISTRATION: The protocol for the study was pre-registered on ZENODO ( https://zenodo.org/record/7064624#.Y4DIAHbMJD8 ).


Assuntos
Disseminação de Informação , Projetos de Pesquisa , Humanos , Disseminação de Informação/métodos , Consenso , Sistema de Registros
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