scholarly journals Clinical relevance assessment of animal preclinical research (RAA) tool: development and explanation

PeerJ ◽  
2021 ◽  
Vol 9 ◽  
pp. e10673
Author(s):  
Kurinchi S. Gurusamy ◽  
David Moher ◽  
Marilena Loizidou ◽  
Irfan Ahmed ◽  
Marc T. Avey ◽  
...  
Keyword(s):  
Clinical Benefit ◽  
Clinical Relevance ◽  
Research Integrity ◽  
Delphi Panel ◽  
Preclinical Studies ◽  
Delphi Consensus ◽  
Preclinical Research ◽  
Modified Delphi ◽  
Relevance Assessment ◽  
Model Research

Background Only a small proportion of preclinical research (research performed in animal models prior to clinical trials in humans) translates into clinical benefit in humans. Possible reasons for the lack of translation of the results observed in preclinical research into human clinical benefit include the design, conduct, and reporting of preclinical studies. There is currently no formal domain-based assessment of the clinical relevance of preclinical research. To address this issue, we have developed a tool for the assessment of the clinical relevance of preclinical studies, with the intention of assessing the likelihood that therapeutic preclinical findings can be translated into improvement in the management of human diseases. Methods We searched the EQUATOR network for guidelines that describe the design, conduct, and reporting of preclinical research. We searched the references of these guidelines to identify further relevant publications and developed a set of domains and signalling questions. We then conducted a modified Delphi-consensus to refine and develop the tool. The Delphi panel members included specialists in evidence-based (preclinical) medicine specialists, methodologists, preclinical animal researchers, a veterinarian, and clinical researchers. A total of 20 Delphi-panel members completed the first round and 17 members from five countries completed all three rounds. Results This tool has eight domains (construct validity, external validity, risk of bias, experimental design and data analysis plan, reproducibility and replicability of methods and results in the same model, research integrity, and research transparency) and a total of 28 signalling questions and provides a framework for researchers, journal editors, grant funders, and regulatory authorities to assess the potential clinical relevance of preclinical animal research. Conclusion We have developed a tool to assess the clinical relevance of preclinical studies. This tool is currently being piloted.

scholarly journals Care bundle to reduce readmission in patients with heart failure: a modified Delphi consensus panel in Argentina

BMJ Open ◽  
2020 ◽  
Vol 10 (12) ◽  
pp. e040028
Author(s):  
Javier Roberti ◽  
Tomás Vita ◽  
Jimena Piastrella ◽  
Carlos Porley ◽  
Lisandro Pereyra ◽  
...  
Keyword(s):  
Heart Failure ◽  
Mixed Method ◽  
Continuum Of Care ◽  
Care Bundle ◽  
Delphi Panel ◽  
Evidence Based ◽  
Delphi Consensus ◽  
Lifestyle Habits ◽  
Modified Delphi ◽  
Patients With Heart Failure

ObjectivesThe aim of this study was to develop consensus among Argentine cardiologists on a care bundle to reduce readmissions of patients with heart failure (HF).SettingHospitals and cardiology clinics in Argentina that provide in-hospital care for patients with HF.ParticipantsTwenty-four cardiology experts participated in the two online rounds and 18 (75%) of them participated in the third-round meeting.MethodsThis study used a mixed-method design; it was conducted between August 2019 and January 2020. The development of a care bundle (a set of evidence-based interventions applied to improve clinical outcomes) involved three phases: (1) a literature review to define the list of interventions to be evaluated; (2) a modified Delphi panel to select interventions for the bundle and (3) definition of the HF care bundle. Also, the process included three rounds of scoring.ResultsTwenty-six interventions were evaluated. The interventions in the final bundle covered four categories: medication, continuum of care, lifestyle habits, predischarge tests. These were: medication: beta-blockers, angiotensin receptor neprilysin inhibitors or ACE-inhibitors, furosemide and antimineralocorticoids; continuum of care: follow-up appointment, daily weight monitoring; lifestyle habits: smoking cessation counselling and low-sodium diet; predischarge tests: renal function, ionogram, blood pressure control, echocardiogram and determination of decompensating cause.ConclusionFollowing a systematic mixed-method approach, we have developed a care bundle of interventions that could decrease readmission of patients with HF. The application of this bundle could contribute to scale evidence-based interventions.

scholarly journals A Model Research Curriculum for Emergency Medicine Residency: A Modified Delphi Consensus

2020 ◽  
Author(s):  
Nicholas Hartman ◽  
Jaime Jordan ◽  
Michael Gottlieb ◽  
Simon A. Mahler ◽  
David Cline ◽  
...  
Keyword(s):  
Emergency Medicine ◽  
Delphi Consensus ◽  
Modified Delphi ◽  
Model Research ◽  
Research Curriculum

scholarly journals Immune-mediated diseases and thromboembolic events: a modified Delphi panel

2021 ◽  
pp. 1-1
Author(s):  
Nassir Azimi ◽  
Freddy Caldera ◽  
Stan Cohen ◽  
James Conners ◽  
Timothy Fernandes ◽  
...  
Keyword(s):  
Delphi Panel ◽  
Thromboembolic Events ◽  
Modified Delphi ◽  
Immune Mediated

scholarly journals Aromatic L-amino Acid Decarboxylase (AADC) deficiency: results from an Italian modified Delphi consensus

2021 ◽  
Vol 47 (1) ◽  
Author(s):  
Carlo Fusco ◽  
◽  
Vincenzo Leuzzi ◽  
Pasquale Striano ◽  
Roberta Battini ◽  
...  
Keyword(s):  
Amino Acid ◽  
Diagnostic Delay ◽  
Steering Committee ◽  
Outcome Data ◽  
Diagnosis And Treatment ◽  
Acid Decarboxylase ◽  
Delphi Consensus ◽  
Amino Acid Decarboxylase ◽  
Modified Delphi ◽  
Number Of Patients

Abstract Background Aromatic L-amino acid decarboxylase (AADC) deficiency is a rare and underdiagnosed neurometabolic disorder resulting in a complex neurological and non-neurological phenotype, posing diagnostic challenges resulting in diagnostic delay. Due to the low number of patients, gathering high-quality scientific evidence on diagnosis and treatment is difficult. Additionally, based on the estimated prevalence, the number of undiagnosed patients is likely to be high. Methods Italian experts in AADC deficiency formed a steering committee to engage clinicians in a modified Delphi consensus to promote discussion, and support research, dissemination and awareness on this disorder. Five experts in the field elaborated six main topics, each subdivided into 4 statements and invited 13 clinicians to give their anonymous feedback. Results 100% of the statements were answered and a consensus was reached at the first round. This enabled the steering committee to acknowledge high rates of agreement between experts on clinical presentation, phenotypes, diagnostic work-up and treatment strategies. A research gap was identified in the lack of standardized cognitive and motor outcome data. The need for setting up an Italian working group and a patients’ association, together with the dissemination of knowledge inside and outside scientific societies in multiple medical disciplines were recognized as critical lines of intervention. Conclusions The panel expressed consensus with high rates of agreement on a series of statements paving the way to disseminate clear messages concerning disease presentation, diagnosis and treatment and strategic interventions to disseminate knowledge at different levels. Future lines of research were also identified.

Vaccinations in patients with multiple sclerosis: A Delphi consensus statement

2020 ◽  
pp. 135245852095231 ◽  
Author(s):  
Agostino Riva ◽  
Valeria Barcella ◽  
Simone V Benatti ◽  
Marco Capobianco ◽  
Ruggero Capra ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Seasonal Influenza ◽  
Careful Consideration ◽  
Delphi Consensus ◽  
Consensus Process ◽  
Disease Modifying Drugs ◽  
Risks And Benefits ◽  
Modified Delphi ◽  
Increased Risk ◽  
Evidence Based Decision Making

Background: Patients with multiple sclerosis (MS) are at increased risk of infection. Vaccination can mitigate these risks but only if safe and effective in MS patients, including those taking disease-modifying drugs. Methods: A modified Delphi consensus process (October 2017–June 2018) was used to develop clinically relevant recommendations for making decisions about vaccinations in patients with MS. A series of statements and recommendations regarding the efficacy, safety and timing of vaccine administration in patients with MS were generated in April 2018 by a panel of experts based on a review of the published literature performed in October 2017. Results: Recommendations include the need for an ‘infectious diseases card’ of each patient’s infectious and immunisation history at diagnosis in order to exclude and eventually treat latent infections. We suggest the implementation of the locally recommended vaccinations, if possible at MS diagnosis, otherwise with vaccination timing tailored to the planned/current MS treatment, and yearly administration of the seasonal influenza vaccine regardless of the treatment received. Conclusion: Patients with MS should be vaccinated with careful consideration of risks and benefits. However, there is an urgent need for more research into vaccinations in patients with MS to guide evidence-based decision making.

scholarly journals Sustainability of Biosimilars in Europe: A Delphi Panel Consensus with Systematic Literature Review

2020 ◽  
Vol 13 (11) ◽  
pp. 400
Author(s):  
Arnold G. Vulto ◽  
Jackie Vanderpuye-Orgle ◽  
Martin van der Graaff ◽  
Steven R. A. Simoens ◽  
Lorenzo Dagna ◽  
...  
Keyword(s):  
Health Care ◽  
Literature Review ◽  
Systematic Literature Review ◽  
Health Care Systems ◽  
Delphi Panel ◽  
The European Union ◽  
Modified Delphi ◽  
Care Systems ◽  
Supply Risks ◽  
The Impact

Introduction: Biosimilars have the potential to enhance the sustainability of evolving health care systems. A sustainable biosimilars market requires all stakeholders to balance competition and supply chain security. However, there is significant variation in the policies for pricing, procurement, and use of biosimilars in the European Union. A modified Delphi process was conducted to achieve expert consensus on biosimilar market sustainability in Europe. Methods: The priorities of 11 stakeholders were explored in three stages: a brainstorming stage supported by a systematic literature review (SLR) and key materials identified by the participants; development and review of statements derived during brainstorming; and a facilitated roundtable discussion. Results: Participants argued that a sustainable biosimilar market must deliver tangible and transparent benefits to the health care system, while meeting the needs of all stakeholders. Key drivers of biosimilar market sustainability included: (i) competition is more effective than regulation; (ii) there should be incentives to ensure industry investment in biosimilar development and innovation; (iii) procurement processes must avoid monopolies and minimize market disruption; and (iv) principles for procurement should be defined by all stakeholders. However, findings from the SLR were limited, with significant gaps on the impact of different tender models on supply risks, savings, and sustainability. Conclusions: A sustainable biosimilar market means that all stakeholders benefit from appropriate and reliable access to biological therapies. Failure to care for biosimilar market sustainability may impoverish biosimilar development and offerings, eventually leading to increased cost for health care systems and patients, with fewer resources for innovation.

ID: 3519259 BEYOND THE RECENT MODIFIED DELPHI CONSENSUS STATEMENTS ON WATER EXCHANGE (WE) - MORE NOVEL BENEFITS OF WE.

2021 ◽  
Vol 93 (6) ◽  
pp. AB35-AB36
Author(s):  
Yu-Hsi Hsieh ◽  
Chih Wei Tseng ◽  
Malcolm Koo ◽  
Felix W. Leung
Keyword(s):  
Water Exchange ◽  
Delphi Consensus ◽  
Modified Delphi ◽  
Consensus Statements

scholarly journals Diagnosis, treatment, and follow-up of heart failure patients by general practitioners: A Delphi consensus statement

PLoS ONE ◽  
2020 ◽  
Vol 15 (12) ◽  
pp. e0244485
Author(s):  
Caroline Verhestraeten ◽  
Gijs Weijers ◽  
Daphne Debleu ◽  
Agnieszka Ciarka ◽  
Marc Goethals ◽  
...  
Keyword(s):  
Heart Failure ◽  
General Practitioner ◽  
General Practitioners ◽  
Early Stage ◽  
Blood Analysis ◽  
Care Process ◽  
Delphi Panel ◽  
Delphi Consensus ◽  
Heart Failure Patients

Aims Creation of an algorithm that includes the most important parameters (history, clinical parameters, and anamnesis) that can be linked to heart failure, helping general practitioners in recognizing heart failure in an early stage and in a better follow-up of the patients. Methods and results The algorithm was created using a consensus-based Delphi panel technique with fifteen general practitioners and seven cardiologists from Belgium. The method comprises three iterations with general statements on diagnosis, referral and treatment, and follow-up. Consensus was obtained for the majority of statements related to diagnosis, referral, and follow-up, whereas a lack of consensus was seen for treatment statements. Based on the statements with good and perfect consensus, an algorithm for general practitioners was assembled, helping them in diagnoses and follow-up of heart failure patients. The diagnosis should be based on three essential pillars, i.e. medical history, anamnesis and clinical examination. In case of suspected heart failure, blood analysis, including the measurement of NT-proBNP levels, can already be performed by the general practitioner followed by referral to the cardiologist who is then responsible for proper diagnosis and initiation of treatment. Afterwards, a multidisciplinary health care process between the cardiologist and the general practitioner is crucial with an important role for the general practitioner who has a key role in the up-titration of heart failure medication, down-titration of the dose of diuretics and to assure drug compliance. Conclusions Based on the consensus levels of statements in a Delphi panel setting, an algorithm is created to help general practitioners in the diagnosis and follow-up of heart failure patients.

scholarly journals Distal rectus femoris surgery in children with cerebral palsy: results of a Delphi consensus project

2021 ◽  
pp. 1-9
Author(s):  
Robert M. Kay ◽  
Kristan Pierz ◽  
James McCarthy ◽  
H. Kerr Graham ◽  
Henry Chambers ◽  
...  
Keyword(s):  
Cerebral Palsy ◽  
Rectus Femoris ◽  
Delphi Consensus ◽  
Level Of Evidence ◽  
Modified Delphi ◽  
International Panel ◽  
Children With Cerebral Palsy ◽  
Stiff Knee ◽  
Paediatric Orthopaedic ◽  
Gmfcs Level

Purpose The purpose of this study was for an international panel of experts to establish consensus indications for distal rectus femoris surgery in children with cerebral palsy (CP) using a modified Delphi method. Methods The panel used a five-level Likert scale to record agreement or disagreement with 33 statements regarding distal rectus femoris surgery. The panel responded to statements regarding general characteristics, clinical indications, computerized gait data, intraoperative techniques and outcome measures. Consensus was defined as at least 80% of responses being in the highest or lowest two of the five Likert ratings, and general agreement as 60% to 79% falling into the highest or lowest two ratings. There was no agreement if neither threshold was reached. Results Consensus or general agreement was reached for 17 of 33 statements (52%). There was general consensus that distal rectus femoris surgery is better for stiff knee gait than is proximal rectus femoris release. There was no consensus about whether the results of distal rectus femoris release were comparable to those following distal rectus femoris transfer. Gross Motor Function Classification System (GMFCS) level was an important factor for the panel, with the best outcomes expected in children functioning at GMFCS levels I and II. The panel also reached consensus that they do distal rectus femoris surgery less frequently than earlier in their careers, in large part reflecting the narrowing of indications for this surgery over the last decade. Conclusion This study can help paediatric orthopaedic surgeons optimize decision-making for, and outcomes of, distal rectus femoris surgery in children with CP. Level of evidence V

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