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European Journal of Cancer (Oxford,... May 2023Local treatment improves the outcomes for oligometastatic disease (OMD, i.e. an intermediate state between locoregional and widespread disseminated disease). However,...
BACKGROUND
Local treatment improves the outcomes for oligometastatic disease (OMD, i.e. an intermediate state between locoregional and widespread disseminated disease). However, consensus about the definition, diagnosis and treatment of oligometastatic oesophagogastric cancer is lacking. The aim of this study was to develop a multidisciplinary European consensus statement on the definition, diagnosis and treatment of oligometastatic oesophagogastric cancer.
METHODS
In total, 65 specialists in the multidisciplinary treatment for oesophagogastric cancer from 49 expert centres across 16 European countries were requested to participate in this Delphi study. The consensus finding process consisted of a starting meeting, 2 online Delphi questionnaire rounds and an online consensus meeting. Input for Delphi questionnaires consisted of (1) a systematic review on definitions of oligometastatic oesophagogastric cancer and (2) a discussion of real-life clinical cases by multidisciplinary teams. Experts were asked to score each statement on a 5-point Likert scale. The agreement was scored to be either absent/poor (<50%), fair (50%-75%) or consensus (≥75%).
RESULTS
A total of 48 experts participated in the starting meeting, both Delphi rounds, and the consensus meeting (overall response rate: 71%). OMD was considered in patients with metastatic oesophagogastric cancer limited to 1 organ with ≤3 metastases or 1 extra-regional lymph node station (consensus). In addition, OMD was considered in patients without progression at restaging after systemic therapy (consensus). For patients with synchronous or metachronous OMD with a disease-free interval ≤2 years, systemic therapy followed by restaging to consider local treatment was considered as treatment (consensus). For metachronous OMD with a disease-free interval >2 years, either upfront local treatment or systemic treatment followed by restaging was considered as treatment (fair agreement).
CONCLUSION
The OMEC project has resulted in a multidisciplinary European consensus statement for the definition, diagnosis and treatment of oligometastatic oesophagogastric adenocarcinoma and squamous cell cancer. This can be used to standardise inclusion criteria for future clinical trials.
Topics: Humans; Delphi Technique; Neoplasms; Europe
PubMed: 36947929
DOI: 10.1016/j.ejca.2023.02.015 -
RMD Open Mar 2023To develop evidence-based points to consider for cost-effective use of biological and targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARDs) in the... (Review)
Review
Points to consider for cost-effective use of biological and targeted synthetic DMARDs in inflammatory rheumatic diseases: results from an umbrella review and international Delphi study.
OBJECTIVES
To develop evidence-based points to consider for cost-effective use of biological and targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARDs) in the treatment of inflammatory rheumatic diseases, specifically rheumatoid arthritis, psoriatic arthritis and axial spondyloarthritis.
METHODS
Following EULAR procedures, an international task force was formed, consisting of 13 experts in rheumatology, epidemiology and pharmacology from seven European countries. Twelve strategies for cost-effective use of b/tsDMARDs were identified through individual and group discussion. For each strategy, PubMed and Embase were systematically searched for relevant English-language systematic reviews and, for six strategies, additionally for randomised controlled trials (RCTs). Thirty systematic reviews and 21 RCTs were included. Based on the evidence, a set of overarching principles and points to consider was formulated by the task force using a Delphi procedure. Level of evidence (1a-5) and grade (A-D) were determined for each point to consider. Individual voting on the level of agreement (LoA; between 0 (completely disagree) and 10 (completely agree)) was performed anonymously.
RESULTS
The task force agreed on five overarching principles. For 10 of 12 strategies, the evidence was sufficient to formulate one or more points to consider, leading to 20 in total, regarding response prediction, drug formulary use, biosimilars, loading doses, low-dose initial therapy, concomitant conventional synthetic DMARD use, route of administration, medication adherence, disease activity-guided dose optimisation and non-medical drug switching. Ten points to consider (50%) were supported by level 1 or 2 evidence. The mean LoA (SD) varied between 7.9 (1.2) and 9.8 (0.4).
CONCLUSION
These points to consider can be used in rheumatology practices and complement inflammatory rheumatic disease treatment guidelines to incorporate cost-effectiveness in b/tsDMARD treatment.
Topics: Humans; Advisory Committees; Antirheumatic Agents; Arthritis, Rheumatoid; Cost-Benefit Analysis; Delphi Technique
PubMed: 36863753
DOI: 10.1136/rmdopen-2022-002898 -
Consensus views on an advanced breast cancer education curriculum for cancer nurses: A Delphi study.Nurse Education Today May 2023Specialist nursing care is a core indicator of quality care for people living with advanced breast cancer. However, access to and quality of nurse education programmes...
BACKGROUND
Specialist nursing care is a core indicator of quality care for people living with advanced breast cancer. However, access to and quality of nurse education programmes in advanced breast cancer is variable.
OBJECTIVES
This study aims to define the topics for inclusion in an international curriculum for an advanced breast cancer education programme.
METHODS
A modified four-round Delphi study was undertaken with experts by profession and experience in advanced breast cancer. Thirty-four topics related to advanced breast cancer and six online teaching and learning methods were pre-selected following a systematic review. Between September 2021 and March 2022, the expert panel determined the importance of topics for inclusion in the education programme. Consensus was defined by at least 80 % agreement on the highest three points on a 9-point Likert scale.
RESULTS
A total of 31 experts participated in rounds 1-3 of this study, and 156 experts by profession and experience participated in an additional fourth round, including people living with advanced breast cancer (n = 72, 46 %), healthcare professionals (n = 46, 29 %), family members or caregivers of a person diagnosed with advanced breast cancer (n = 30, 19 %) and advocacy professionals working in the area of advanced breast cancer (n = 8, 5 %). In round 4, 36 topics and five of six learning methods reached consensus.
CONCLUSIONS
The results of this study provide a framework to develop education programmes in advanced breast cancer, defining the essential elements of curriculum content for such programmes. The results highlight the need for advanced breast cancer education programmes to use multiple teaching and learning methods to promote nurses' understanding of person-centred supportive care and the physical, psychosocial and spiritual issues experienced by people living with advanced breast cancer.
Topics: Humans; Female; Breast Neoplasms; Consensus; Delphi Technique; Clinical Competence; Curriculum; Nurses
PubMed: 36827744
DOI: 10.1016/j.nedt.2023.105757 -
Journal of Obstetrics and Gynaecology :... Dec 2023Two-round Delphi study carried out in Spain. Three theme-based blocks were set out: 1) Patient profiles: therapeutic goal and parameters to be analysed according to...
Two-round Delphi study carried out in Spain. Three theme-based blocks were set out: 1) Patient profiles: therapeutic goal and parameters to be analysed according to POSEIDON patient profiles; 2) Ovarian stimulation protocols with antagonists: monotherapy (FSH) vs combined therapy (FSH + LH/HMG); 3) Safety and effectiveness of the devices. The antral follicle count and the anti-Müllerian hormone level were considered indicators that can be used to predict ovarian response. More than 80% of the participants agreed that FSH monotherapy is the recommended regimen in normal/hyper-responsive patients of < 35 years of age; that 150-300 IU is the dose to be used in ovarian stimulation in monotherapy depending on clinical parameters; and that FSH monotherapy improves patients' comfort compared to two combined drugs. It was unanimously considered that the type of device used by the patient influences the comfort of the treatment.IMPACT STATEMENT There is currently no consensus on the optimal treatment for controlled ovarian stimulation for patients undergoing IVF which leads to highly variable clinical practices. This study's strong point is that, since it is a consensus, it has been possible to include more topics than would normally be dealt with in a systematic review or guidelines, which are generally based on a strict method that restricts the scope of the research. Experts have reached a consensus on most of the statements and based on these they have issued consensus statements that will enable the optimal use of gonadotropins in IVF. This Delphi consensus provides a real-life clinical perspective on gonadotropin usage in IVF.
Topics: Pregnancy; Female; Humans; Follicle Stimulating Hormone; Delphi Technique; Fertilization in Vitro; Pregnancy Rate; Spain; Gonadotropins; Ovulation Induction
PubMed: 36772946
DOI: 10.1080/01443615.2023.2174692 -
Nutrients Jan 2023Disease-related malnutrition (DRM) affects approximately a third of hospitalized patients and is associated with an increased risk of morbimortality. However, DRM is...
Disease-related malnutrition (DRM) affects approximately a third of hospitalized patients and is associated with an increased risk of morbimortality. However, DRM is often underdiagnosed and undertreated. Our aim is to evaluate the prognostic value of morphofunctional tools and tests for nutritional assessment in clinical practice. A systematic literature review was conducted to identify studies relating to the morphofunctional assessment of nutritional status and mortality or complications. Evidence was evaluated using the GRADE (Grading of Recommendations, Assessment, Development, and Evaluations) method. Twelve GRADE recommendations were made and divided into seven topics: food intake and nutrient assimilation, anthropometry, biochemical analysis, hand grip strength, phase angle, muscle imaging, and functional status and quality of life. From these recommendations, 37 statements were developed and scored in a two-survey Delphi method by 183 experts. A consensus was reached on accepting 26/37 statements. Surveys had high internal consistency and high inter-rater reliability. In conclusion, evidence-based recommendations were made on the prognostic value of morphofunctional assessment tools and tests to assess malnutrition, most of which were found to be feasible in routine clinical practice, according to expert opinions.
Topics: Humans; Hand Strength; Consensus; Delphi Technique; Quality of Life; Reproducibility of Results; Malnutrition
PubMed: 36771319
DOI: 10.3390/nu15030612 -
British Journal of Anaesthesia Apr 2023Mortality, morbidity, and organ failure are important and common serious harms after surgery. However, there are many candidate measures to describe these outcome...
BACKGROUND
Mortality, morbidity, and organ failure are important and common serious harms after surgery. However, there are many candidate measures to describe these outcome domains. Definitions of these measures are highly variable, and validity is often unclear. As part of the International Standardised Endpoints in Perioperative Medicine (StEP) initiative, this study aimed to derive a set of standardised and valid measures of mortality, morbidity, and organ failure for use in perioperative clinical trials.
METHODS
Three domains of endpoints (mortality, morbidity, and organ failure) were explored through systematic literature review and a three-stage Delphi consensus process using methods consistently applied across the StEP initiative. Reliability, feasibility, and patient-centredness were assessed in round 3 of the consensus process.
RESULTS
A high level of consensus was achieved for two mortality time points, 30-day and 1-yr mortality, and these two measures are recommended. No organ failure endpoints achieved threshold criteria for consensus recommendation. The Clavien-Dindo classification of complications achieved threshold criteria for consensus in round 2 of the Delphi process but did not achieve the threshold criteria in round 3 where it scored equivalently to the Post Operative Morbidity Survey. Clavien-Dindo therefore received conditional endorsement as the most widely used measure. No composite measures of organ failure achieved an acceptable level of consensus.
CONCLUSIONS
Both 30-day and 1-yr mortality measures are recommended. No measure is recommended for organ failure. One measure (Clavien-Dindo) is conditionally endorsed for postoperative morbidity, but our findings suggest that no single endpoint offers a reliable and valid measure to describe perioperative morbidity that is not dependent on the quality of deli-vered care. Further refinement of current measures, or development of novel measures, of postoperative morbidity might improve consensus in this area.
Topics: Humans; Perioperative Care; Consensus; Reproducibility of Results; Perioperative Medicine; Morbidity; Delphi Technique
PubMed: 36697275
DOI: 10.1016/j.bja.2022.12.012 -
BMJ Open Jan 2023A clear development process and scientifically validated clinical practice competencies in standard critical care nursing (SCCN) have not yet been developed in Japan....
OBJECTIVES
A clear development process and scientifically validated clinical practice competencies in standard critical care nursing (SCCN) have not yet been developed in Japan. Thus, this study aimed to develop a consensus-based set of SCCN competencies to provide a framework for critical care nursing education, training and evaluation.
DESIGN
Multistep, modified Delphi study (a systematic review, focus group interviews, a three-round web-based Delphi survey and an external validation process).
PARTICIPANTS
A systematic review of 23 studies, focus group interviews by 12 experts, a Delphi survey by 239 critical care experts (physicians, nurses and physical therapists) and an external validation by 5 experts (physicians and nurses).
RESULTS
A systematic review identified 685 unique competencies. The focus group interviews resulted in the addition of 3 performance indicator items, a synthesis of 2 subdomains and 10 elements. Of the 239 participants, 218 (91.2%), 209 (98.9%) and 201 (96.2%) responded in rounds 1, 2 and 3 of the Delphi survey, respectively. After round 3, 57 items were below the consensus level and were removed in the final round. External validation process feedback was received from experts after two revisions to ensure that the final competencies were valid, applicable, useful and clear. The final set of competencies was classified into 6 domains, 26 subdomains, 99 elements and 525 performance indicators.
CONCLUSIONS
This study found a set of SCCN competencies after a multistep, modified Delphi study. The results of this study are robust, and the competency framework can be used in multiple areas to improve clinical practice, including the assessment, training and certification of standard critical care nurses.
Topics: Humans; Critical Care Nursing; Delphi Technique; Clinical Competence; Physicians; Consensus
PubMed: 36697042
DOI: 10.1136/bmjopen-2022-068734 -
Prosthetics and Orthotics International Feb 2023Outcome measures (patient-reported and performance-based) are used widely but not uniformly within the clinical setting for individuals with lower-limb absence (LLA)....
BACKGROUND
Outcome measures (patient-reported and performance-based) are used widely but not uniformly within the clinical setting for individuals with lower-limb absence (LLA). The need for more detailed information by funding bodies, service planners and providers, and researchers requires the systematic and routine use of outcome measures. Currently, there is no consensus on which outcome measure(s) should be used for individuals with LLA. The aim of the International Society of Prosthetics and Orthotics (ISPO) lower-limb Consensus Outcome Measures for Prosthetic and Amputation Services (COMPASS) was to produce a recommended list of outcome measures to be actively promoted for routine use within clinical practice before and after an episode of care.
METHODS
Between May and June 2021, 46 users, clinicians, researchers, managers, and policymakers working in the field of LLA and prosthetic users met virtually. Consensus participants were first asked to complete an online survey with questions based on the results from a systematic review and the outcomes from an expert panel. A modified Delphi technique was used to determine outcome measures for use in routine clinical practice. This paper discusses the ISPO lower-limb COMPASS process from which recommendations were made.
RESULTS
The ISPO lower-limb COMPASS resulted in the following 6 recommendations: (1) Amputee Mobility Predictor, Timed Up and Go, Two-Minute Walk Test, Prosthetic Evaluation Questionnaire-Residual Limb Health, Prosthetic Evaluation Questionnaire-Utility, and Trinity Amputation and Prosthesis Experience Scales-Revised, which make up the ISPO lower-limb COMPASS ; (2) Comprehensive High-Level Activity Mobility Predictor and Six-Minute Walk Test are 2 additional outcome measures recommended for higher-activity-level individuals with LLA, which make up the COMPASS+ ; (3) Patient-Specific Function Scale makes up the COMPASS Adjunct ; (4) a generic health-related quality of life outcome measure such as the European Quality of Life-5D-5L or Patient-Reported Outcomes Measurement Information System-29 item can be used to supplement the COMPASS; (5) outcome measures suited to low- and middle-income countries need to be developed with a focus on activities such as sitting cross-legged, kneeling, squatting, and other culturally important mobility-related activities; and (6) translation, validation, and open sharing of translated outcome measures included in the COMPASS, COMPASS+, and COMPASS Adjunct occurs.
CONCLUSION
The above recommendations represent the current status of knowledge on outcome measures for LLA based on research and international consensus and hence, will change over time. This work has been developed for clinicians and researchers to improve knowledge on outcome measures to guide clinical decision-making and future research initiatives.
Topics: Humans; Quality of Life; Amputation, Surgical; Artificial Limbs; Amputees; Outcome Assessment, Health Care; Patient Reported Outcome Measures
PubMed: 36629556
DOI: 10.1097/PXR.0000000000000197 -
Annals of the Rheumatic Diseases Jun 2023Application of 'treat-to-target' (T2T) in childhood-onset systemic lupus erythematosus (cSLE) may improve care and health outcomes. This initiative aimed to harmonise...
Towards development of treat to target (T2T) in childhood-onset systemic lupus erythematosus: PReS-endorsed overarching principles and points-to-consider from an international task force.
OBJECTIVES
Application of 'treat-to-target' (T2T) in childhood-onset systemic lupus erythematosus (cSLE) may improve care and health outcomes. This initiative aimed to harmonise existing evidence and expert opinion regarding T2T for cSLE.
METHODS
An international T2T Task Force was formed of specialists in paediatric rheumatology, paediatric nephrology, adult rheumatology, patient and parent representatives. A steering committee formulated a set of draft overarching principles and points-to-consider, based on evidence from systematic literature review. Two on-line preconsensus meeting Delphi surveys explored healthcare professionals' views on these provisional overarching principles and points-to-consider. A virtual consensus meeting employed a modified nominal group technique to discuss, modify and vote on each overarching principle/point-to-consider. Agreement of >80% of Task Force members was considered consensus.
RESULTS
The Task Force agreed on four overarching principles and fourteen points-to-consider. It was agreed that both treatment targets and therapeutic strategies should be subject to shared decision making with the patient/caregivers, with full remission the preferred target, and low disease activity acceptable where remission cannot be achieved. Important elements of the points-to-consider included: aiming for prevention of flare and organ damage; glucocorticoid sparing; proactively addressing factors that impact health-related quality of life (fatigue, pain, mental health, educational challenges, medication side effects); and aiming for maintenance of the target over the long-term. An extensive research agenda was also formulated.
CONCLUSIONS
These international, consensus agreed overarching principles and points-to-consider for T2T in cSLE lay the foundation for future T2T approaches in cSLE, endorsed by the Paediatric Rheumatology European Society.
Topics: Adult; Child; Humans; Quality of Life; Surveys and Questionnaires; Remission Induction; Lupus Erythematosus, Systemic; Advisory Committees
PubMed: 36627168
DOI: 10.1136/ard-2022-223328 -
Pediatric Nephrology (Berlin, Germany) Aug 2023Continuous kidney replacement therapy (CKRT) has become an integral part of the care of critically ill children. However, uncertainty exists regarding the current state...
BACKGROUND
Continuous kidney replacement therapy (CKRT) has become an integral part of the care of critically ill children. However, uncertainty exists regarding the current state of how CKRT is prescribed and delivered in children. The main objective of this study was to identify the current practices for pediatric CKRT.
METHODS
We conducted a systematic review of the literature from 2012 to 2022 to identify data regarding CKRT timing of initiation, dosing, anticoagulation, fluid removal, and quality monitoring. Using this data, we then performed a two-round modified Delphi process using a multinational internet-assisted survey of prescribers of CKRT.
RESULTS
The survey was constructed using 172 articles that met inclusion criteria (12% of studies were pediatric focused). A total of 147 and 126 practitioners completed the survey in rounds 1 and 2, respectively. Participants represented Europe (9.5-11.6%) and North America including pediatric intensivists, nephrologists, and advance practice providers. Consensus (defined as a ≥ 75% participant response of "sometimes" or "always") was achieved for 26 statements. There was consensus in the practices of CKRT initiation, dosing, method of anticoagulation, and fluid removal. In contrast, there appears to be greater variability in the methods used for monitoring anticoagulation and the quality of the delivered treatment.
CONCLUSIONS
Our study results suggest that the current state of pediatric CKRT practice is reflective of the literature over the last 10 years, which is largely based on the care of adult patients. This data provides a framework to study best practices to further improve outcomes for children receiving CKRT. A higher resolution version of the Graphical abstract is available as Supplementary information.
Topics: Adult; Child; Humans; Delphi Technique; Acute Kidney Injury; Continuous Renal Replacement Therapy; Blood Coagulation; Anticoagulants
PubMed: 36625932
DOI: 10.1007/s00467-022-05864-z