A Delphi-method-based consensus guideline for definition of treatment-resistant depression for clinical trials.
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SUBMITTER: Sforzini L
PROVIDER: S-EPMC9095475 | biostudies-literature | 2022 Mar
REPOSITORIES: biostudies-literature
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A Delphi-method-based consensus guideline for definition of treatment-resistant depression for clinical trials.
Sforzini Luca L Worrell Courtney C Kose Melisa M Anderson Ian M IM Aouizerate Bruno B Arolt Volker V Bauer Michael M Baune Bernhard T BT Blier Pierre P Cleare Anthony J AJ Cowen Philip J PJ Dinan Timothy G TG Fagiolini Andrea A Ferrier I Nicol IN Hegerl Ulrich U Krystal Andrew D AD Leboyer Marion M McAllister-Williams R Hamish RH McIntyre Roger S RS Meyer-Lindenberg Andreas A Miller Andrew H AH Nemeroff Charles B CB Normann Claus C Nutt David D Pallanti Stefano S Pani Luca L Penninx Brenda W J H BWJH Schatzberg Alan F AF Shelton Richard C RC Yatham Lakshmi N LN Young Allan H AH Zahn Roland R Aislaitner Georgios G Butlen-Ducuing Florence F Fletcher Christine C Haberkamp Marion M Laughren Thomas T Mäntylä Fanni-Laura FL Schruers Koen K Thomson Andrew A Arteaga-Henríquez Gara G Benedetti Francesco F Cash-Gibson Lucinda L Chae Woo Ri WR De Smedt Heidi H Gold Stefan M SM Hoogendijk Witte J G WJG Mondragón Valeria Jordán VJ Maron Eduard E Martynowicz Jadwiga J Melloni Elisa E Otte Christian C Perez-Fuentes Gabriela G Poletti Sara S Schmidt Mark E ME van de Ketterij Edwin E Woo Katherine K Flossbach Yanina Y Ramos-Quiroga J Antoni JA Savitz Adam J AJ Pariante Carmine M CM
Molecular psychiatry 20211215 3
Criteria for treatment-resistant depression (TRD) and partially responsive depression (PRD) as subtypes of major depressive disorder (MDD) are not unequivocally defined. In the present document we used a Delphi-method-based consensus approach to define TRD and PRD and to serve as operational criteria for future clinical studies, especially if conducted for regulatory purposes. We reviewed the literature and brought together a group of international experts (including clinicians, academics, resea ...[more]
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| S-EPMC7613090 | biostudies-literature
Project description:BackgroundTreatment-resistant depression (TRD) is defined by the European Medicines Agency as a lack of clinically meaningful improvement after treatment, with at least two different antidepressants. Individual, familiar, and socio-economic burden of TRD is huge. Given the lack of clear guidelines, the large variability of TRD approaches across different countries and the availability of new medications to meet the need of effective and rapid acting therapeutic strategies, it is important to understand the consensus regarding the clinical characteristics and treatment pathways of patients with TRD in Italian routine clinical practice, particularly in view of the recent availability of esketamine nasal spray.MethodsA Delphi questionnaire with 17 statements (with a 7 points Likert scale for agreement) was administered via a customized web-based platform to Italian psychiatrists with at least 5 years of experience and specific expertise in the field of depression. In the second-round physicians were asked to answer the same statements considering the interquartile range of each question as an index of their colleagues' responses. Stata 16.1 software was used for the analyses.ResultsSixty panellists, representative of the Italian territory, answered the questionnaire at the first round. For 8/17 statements more than 75% of panellists reached agreement and a high consensus as they assigned similar scores; for 4 statements the panellists assigned similar scores but in the middle of the Likert scale showing a moderate agreement with the statement, while for 5 statements there was indecision in the agreement and low consensus with the statement.ConclusionsThis Delphi Panel showed that there is a wide heterogeneity in Italy in the management of TRD patients, and a compelling need of standardised strategies and treatments specifically approved for TRD. A high level of consensus and agreement was obtained about the importance of adding lithium and/or antipsychotics as augmentation therapies and in the meantime about the need for long-term maintenance therapy. A high level of consensus and agreement was equally reached for the identification of esketamine nasal spray as the best option for TRD patients and for the possibility to administrate without difficulties esketamine in a community outpatient setting, highlighting the benefit of an appropriate educational support for patients.
| S-EPMC10668442 | biostudies-literature
Project description:People with COVID-19 might have sustained postinfection sequelae. Known by a variety of names, including long COVID or long-haul COVID, and listed in the ICD-10 classification as post-COVID-19 condition since September, 2020, this occurrence is variable in its expression and its impact. The absence of a globally standardised and agreed-upon definition hampers progress in characterisation of its epidemiology and the development of candidate treatments. In a WHO-led Delphi process, we engaged with an international panel of 265 patients, clinicians, researchers, and WHO staff to develop a consensus definition for this condition. 14 domains and 45 items were evaluated in two rounds of the Delphi process to create a final consensus definition for adults: post-COVID-19 condition occurs in individuals with a history of probable or confirmed SARS-CoV-2 infection, usually 3 months from the onset, with symptoms that last for at least 2 months and cannot be explained by an alternative diagnosis. Common symptoms include, but are not limited to, fatigue, shortness of breath, and cognitive dysfunction, and generally have an impact on everyday functioning. Symptoms might be new onset following initial recovery from an acute COVID-19 episode or persist from the initial illness. Symptoms might also fluctuate or relapse over time. A separate definition might be applicable for children. Although the consensus definition is likely to change as knowledge increases, this common framework provides a foundation for ongoing and future studies of epidemiology, risk factors, clinical characteristics, and therapy.
| S-EPMC8691845 | biostudies-literature
Project description:IntroductionThe authors describe the medications for treatment-resistant depression (TRD) in phase II/III of clinical development in the EU and USA and provide an opinion on how current treatment can be improved in the near future. Areas covered: Sixty-two trials were identified in US and EU clinical trial registries that included six investigational compounds in recent phase III development and 12 others in recent phase II clinical trials. Glutamatergic agents have been the focus of many studies. A single intravenous dose of the glutamatergic modulator ketamine produces a robust and rapid antidepressant effect in persons with TRD; this effect continues to remain significant for 1 week. This observation was a turning point that opened the way for other, more selective glutamatergic modulators (intranasal esketamine, AVP-786, AVP-923, AV-101, and rapastinel). Of the remaining compounds, monoclonal antibodies open highly innovative therapeutic options, based on new pathophysiological approaches to depression. Expert commentary: Promising new agents are emerging for TRD treatment. Glutamatergic modulators likely represent a very promising alternative to monoaminergic antidepressant monotherapy. We could see the arrival of the first robust and rapid acting antidepressant drug in the near future, which would strongly facilitate the ultimate goal of recovery in persons with TRD.
| S-EPMC5418088 | biostudies-literature
Project description:BackgroundTreatment-resistant depression (TRD) is a debilitating chronic mental illness that confers increased morbidity and mortality, decreases the quality of life, impairs occupational, social, and offspring development, and translates into increased costs on the healthcare system. The goal of this study is to reach an agreement on the concept, definition, staging model, and assessment of TRD.MethodsThis study involved a review of the literature and a modified Delphi process for consensus agreement. The Appraisal of Guidelines for Research & Evaluation II guidelines were followed for the literature appraisal. Literature was assessed for quality and strength of evidence using the grading, assessment, development, and evaluations system. Canadian national experts in depression were invited for the modified Delphi process based on their prior clinical and research expertize. Survey items were considered to have reached a consensus if 80% or more of the experts supported the statement.ResultsFourteen Canadian experts were recruited for three rounds of surveys to reach a consensus on a total of 27 items. Experts agreed that a dimensional definition for treatment resistance was a useful concept to describe the heterogeneity of this illness. The use of staging models and clinical scales was recommended in evaluating depression. Risk factors and comorbidities were identified as potential predictors for treatment resistance.ConclusionsTRD is a meaningful concept both for clinical practice and research. An operational definition for TRD will allow for opportunities to improve the validity of predictors and therapeutic options for these patients.
| S-EPMC8049072 | biostudies-literature
Project description:ObjectivesTo identify the biomechanical and organisational constraints that influence pregnancy outcomes and define the exposure levels at which the risks for pregnancy become significant.Setting and participantsWe applied a consensus method (Delphi) consisting of a literature review followed by expert opinions on exposure levels. The group of experts was made up of 12 people from different medical specialities and working in various structures in France.Outcome measuresThe studied variables were: (1) exposure: night work/shift work, weekly hours at work, lifting of heavy loads, prolonged standing and multiple exposure and (2) pregnancy outcomes: prematurity, low birth weight and spontaneous miscarriages.ResultsThe consensus method resulted in the following recommendations. The time spent working must not exceed 40 hours/week; in the absence of a consensus on the level of exposure, night and/or shift work must be avoided; prolonged standing must not exceed 3 hours/day; lifting must be limited to carrying loads <11 kg, with a daily load <100 kg; multiple exposure must be avoided, in particular: vibration, night work/shift work, time spent working exceeding 40 hours/week, prolonged standing and lifting of heavy loads.ConclusionsThese results could help the occupational physician to address the question of whether an exposed employee should remain at work, considering her individual characteristics (medical history, family situation, socioeconomic level, etc) in consultation with pregnancy specialists (obstetricians, midwives).
| S-EPMC8905964 | biostudies-literature
Project description:IntroductionDespite being more than two decades of research, mesenchymal stromal cell (MSC) treatments are still struggling to cross the translational gap. Two key issues that likely contribute to these failures are (1) the lack of clear definition for MSC and (2) poor quality of reporting in MSC clinical studies. To address these issues, we propose a modified Delphi study to establish a consensus definition for MSC and reporting guidelines for clinical trials of MSC therapy.Methods and analysisWe will conduct a three-round international modified Delphi survey. Findings from a recent scoping review examining how MSCs are defined and reported in preclinical and clinical studies were used to draft the initial survey for round 1 of our Delphi. Participants will include a 'core group' of individuals as well as researchers whose work was captured in our scoping review. The core group will include stakeholders from different research fields including developmental biology, translational science, research methods, regulatory practices, scholarly journal editing and industry. The first two survey rounds will be online, and the final round will take place in person. Each participant will be asked to rate their agreement on potential MSC definition characteristics and reporting items using a Likert scale. After each round, we will analyse the data to determine which items have reached consensus for inclusion/exclusion, and then develop a revised questionnaire for any new items, or items that did not reach consensus.Ethics and disseminationThis study received ethical approval from the Ottawa Health Research Network Research Ethics Board. To support the dissemination of our findings, we will use an evidence-based 'integrated knowledge translation' approach to engage knowledge users from the inception of the research. This will allow us to develop a tailored end-of-project knowledge translation plan to support and ensure dissemination and implementation of the Delphi results.
| S-EPMC8499309 | biostudies-literature
Project description:ObjectiveIn epilepsy, early diagnosis, accurate determination of epilepsy type, proper selection of antiseizure medication, and monitoring are all essential. However, despite recent therapeutic advances and conceptual reconsiderations in the classification and management of epilepsy, serious gaps are still encountered in day-to-day practice in Egypt as well as several other resource-limited countries. Premature mortality, poor quality of life, socio-economic burden, cognitive problems, poor treatment outcomes, and comorbidities are major challenges that require urgent actions to be implemented at all levels. In recognition of this, a group of Egyptian epilepsy experts met through a series of consecutive meetings to specify the main concepts concerning the diagnosis and management of epilepsy, with the ultimate goal of establishing a nationwide Egyptian consensus.MethodsThe consensus was developed through a modified Delphi methodology. A thorough review of the most recent relevant literature and international guidelines was performed to evaluate their applicability to the Egyptian situation. Afterward, several remote and live rounds were scheduled to reach a final agreement for all listed statements.ResultsOf 278 statements reviewed in the first round, 256 achieved ≥80% agreement. Live discussion and refinement of the 22 statements that did not reach consensus during the first round took place, followed by final live voting then consensus was achieved for all remaining statements.SignificanceWith the implementation of these unified recommendations, we believe this will bring about substantial improvements in both the quality of care and treatment outcomes for persons with epilepsy in Egypt.Plain language summaryThis work represents the efforts of a group of medical experts to reach an agreement on the best medical practice related to people with epilepsy based on previously published recommendations while taking into consideration applicable options in resource-limited countries. The publication of this document is expected to minimize many malpractice issues and pave the way for better healthcare services on both individual and governmental levels.
| S-EPMC11296093 | biostudies-literature
Project description:Background and hypothesisThere is limited evidence to guide the approaches to clozapine treatment. Accordingly, an international initiative was undertaken with the aim of developing consensus recommendations for the optimization of clozapine monotherapy.Study designWe conducted an online Delphi survey among members of the Treatment Response and Resistance in Psychosis (TRRIP) working group comprising experts from twenty-nine countries. The threshold criterion for a consensus recommendation was ≥ 75% agreement ("agree" and "strongly agree" responses) on a question. Agreement of ≥ 50% but < 75% in a second or third Delphi round was deemed to provide guidance.Study resultsForty-nine (first round), 32 (second round), and 48 (third round) of the 91 current TRRIP members participated. Expert recommendations at ≥ 75% comprised second-line treatment with clozapine in cases of persistent positive symptoms with co-occurring extrapyramidal symptoms, tardive dyskinesia, or suicidality/aggression. There was considerable disagreement on myocarditis screening parameters. The management of somatic and neuropsychiatric adverse drug reactions warrants further research for more evidence-based recommendations. Rechallenge with clozapine was recommended for eosinophilia, sinus tachycardia and fever and guidance (agreement ≥ 50%) was reached for pneumonia and thrombocytopenia.ConclusionsGiven the limited evidence available, this consensus-based series of recommendations and guidance statements supports clinical decision-making to optimize clozapine monotherapy and provides guidance for future research in treatment-resistant schizophrenia.
| S-EPMC10318876 | biostudies-literature
Project description:IntroductionClear definitions are essential in science, particularly in the study of abstract phenomena like creativity. Due to its inherent complexity and domain-specific nature, the study of creativity has been complicated, as evidenced by the various definitions used to describe it and the multitude of tools which claim to measure it. Surgery is a safety-critical profession where creativity could be useful in navigating unforeseen problems and circumstances, as well as developing new innovations to improve patient outcomes. To validly and reliably study creativity in surgery, a surgery-specific definition is required. We aim to develop a consensus definition of creativity in surgery, utilizing the existing creativity literature and surgeon input.Methods and analysisThe objective of this study is to generate a consensus definition of creativity in surgery. We will first conduct a focus group comprised of 4-12 highly experienced surgeons to generate knowledge on surgeons' perceptions, attitudes and beliefs about creativity in surgery, collect real-world examples of creativity in surgery, and obtain opinions on the existing definitions of creativity in the literature. The selection of focus group participants will be performed using purposive sampling of the chairs and/or chiefs of each surgical sub-specialty at our home institution. Several questions relating to creativity in surgery will be posed to the focus group, to be rated using a 7-point Likert scale and used as prompts for group discussion. We will also search MEDLINE, PsycINFO and EMBASE to find definitions of creativity in the scientific literature. Six definitions, chosen based on citation frequency and relevancy to surgery, will be presented to the focus group for ranking and discussion. Lastly, in addition to novelty and effectiveness, which are widely accepted as necessary components of creativity, the focus group will be asked to consider the necessity of other components for creativity in surgery, sourced from the scientific literature. Descriptive and thematic analyses are planned for the quantitative and qualitative data, respectively. The results of the focus group will be incorporated in the drafting of five definitions of creativity in surgery, which will be presented as initial Delphi statements in the Delphi study. For the Delphi panel, we will perform non-probability purposive sampling of surgeons and surgeon trainees at our home institution, with a minimum panel size of 12. Panellists will be asked to select the definition of creativity most relevant to surgery, with each Delphi round electronically delivered. After each round, the steering committee will meet to review the results and adjust the statements for the next round based on the feedback. A maximum of 5 rounds will be performed, or until consensus is reached (≥75% agreement). Recruitment is scheduled to begin on 1 August 2024.Ethics and disseminationAll focus group and panellists will be given written and verbal information on the study and provide signed, informed consent. We plan to publish the results of our study in a creativity science- or surgery-focused journal to disseminate the results of our study to relevant stakeholders. We also plan to present the results of our research at local, national, and international conferences.
| S-EPMC11620345 | biostudies-literature