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Journal of the European Academy of... Apr 2023Generalized pustular psoriasis (GPP) is a rare and highly heterogeneous skin disease, characterized by flares of neutrophilic pustules and erythema. As a rare disease...
BACKGROUND
Generalized pustular psoriasis (GPP) is a rare and highly heterogeneous skin disease, characterized by flares of neutrophilic pustules and erythema. As a rare disease with few clinical studies and no standardized management approaches, there is a paucity of knowledge regarding GPP.
OBJECTIVES
Conduct a Delphi panel study to identify current evidence and gain advanced insights into GPP.
METHODS
A systematic literature review was used to identify published literature and develop statements categorized into four key domains: clinical course and flare definition; diagnosis; treatment goals; and holistic management. Statements were rated on a Likert scale by a panel of dermatologists in two rounds of online questionnaires; the threshold for consensus was agreement by ≥80%.
RESULTS
Twenty-one panellists reached consensus on 70.9%, 61.8%, 100.0% and 81.8% of statements in the 'clinical course and flare definition', 'diagnosis', 'treatment goals' and 'holistic management of GPP' domains, respectively. There was clear consensus on GPP being phenotypically, genetically and immunologically distinct from plaque psoriasis. Clinical course is highly variable, with an extensive range of complications. Clinical and histologic features supporting GPP diagnosis reached high levels of agreement, and although laboratory evaluations were considered helpful for diagnosis and monitoring disease severity, there was uncertainty around the value of individual tests. All acute and long-term treatment goals reached consensus, including rapid and sustained clearance of pustules, erythema, scaling and crust, clearance of skin lesions and prevention of new flares. Potential triggers, associated comorbidities and differential diagnoses achieved low rates of consensus, indicating that further evidence is needed.
CONCLUSIONS
Global consensus between dermatologists was reached on clinically meaningful goals for GPP treatment, on key features of GPP flares and on approaches for assessing disease severity and multidisciplinary management of patients. On this basis, we present a management algorithm for patients with GPP for use in clinical practice.
Topics: Humans; Consensus; Delphi Technique; Goals; Psoriasis; Disease Management; Disease Progression
PubMed: 36606566
DOI: 10.1111/jdv.18851 -
International Journal of Radiation... Nov 2019The treatment of nasopharyngeal carcinoma requires high radiation doses. The balance of the risks of local recurrence owing to inadequate tumor coverage versus the...
PURPOSE
The treatment of nasopharyngeal carcinoma requires high radiation doses. The balance of the risks of local recurrence owing to inadequate tumor coverage versus the potential damage to the adjacent organs at risk (OARs) is of critical importance. With advancements in technology, high target conformality is possible. Nonetheless, to achieve the best possible dose distribution, optimal setting of dose targets and dose prioritization for tumor volumes and various OARs is fundamental. Radiation doses should always be guided by the As Low As Reasonably Practicable principle. There are marked variations in practice. This study aimed to develop a guideline to serve as a global practical reference.
METHODS AND MATERIALS
A literature search on dose tolerances and normal-tissue complications after treatment for nasopharyngeal carcinoma was conducted. In addition, published guidelines and protocols on dose prioritization and constraints were reviewed. A text document and preliminary set of variants was circulated to a panel of international experts with publications or extensive experience in the field. An anonymized voting process was conducted to rank the proposed variants. A summary of the initial voting and different opinions expressed by members were then recirculated to the whole panel for review and reconsideration. Based on the comments of the panel, a refined second proposal was recirculated to the same panel. The current guideline was based on majority voting after repeated iteration for final agreement.
RESULTS
Variation in opinion among international experts was repeatedly iterated to develop a guideline describing appropriate dose prioritization and constraints. The percentage of final agreement on the recommended parameters and alternative views is shown. The rationale for the recommendations and the limitations of current evidence are discussed.
CONCLUSIONS
Through this comprehensive review of available evidence and interactive exchange of vast experience by international experts, a guideline was developed to provide a practical reference for setting dose prioritization and acceptance criteria for tumor volumes and OARs. The final decision on the treatment prescription should be based on the individual clinical situation and the patient's acceptance of optimal balance of risk.
Topics: Delphi Technique; GRADE Approach; Humans; International Cooperation; Nasopharyngeal Carcinoma; Nasopharyngeal Neoplasms; Neoplasm Recurrence, Local; Organs at Risk; Radiation Injuries; Radiotherapy Dosage; Radiotherapy Planning, Computer-Assisted; Radiotherapy, Intensity-Modulated; Tumor Burden
PubMed: 31276776
DOI: 10.1016/j.ijrobp.2019.06.2540 -
JAMA Dermatology Oct 2022Laser-assisted drug delivery (LADD) is used for various medical and cosmetic applications. However, there is insufficient evidence-based guidance to assist clinicians...
IMPORTANCE
Laser-assisted drug delivery (LADD) is used for various medical and cosmetic applications. However, there is insufficient evidence-based guidance to assist clinicians performing LADD.
OBJECTIVE
To develop recommendations for the safe and effective use of LADD.
EVIDENCE REVIEW
A systematic literature review of Cochrane Central Register of Controlled Trials, Embase, and MEDLINE was conducted in December 2019 to identify publications reporting research on LADD. A multidisciplinary panel was convened to draft recommendations informed by the systematic review; they were refined through 2 rounds of Delphi survey, 2 consensus meetings, and iterative review by all panelists until unanimous consensus was achieved.
FINDINGS
Of the 48 published studies of ablative fractional LADD that met inclusion criteria, 4 were cosmetic studies; 21, oncologic; and 23, medical (not cosmetic/oncologic), and 6 publications of nonablative fractional LADD were included at the request of the expert panel, producing a total of 54 studies. Thirty-four studies (63.0%) were deemed to have low risk of bias, 17 studies (31.5%) had moderate risk, and 3 (5.5%) had serious risk. The key findings that informed the guidelines developed by the expert panel were as follows: LADD is safe in adults and adolescents (≥12 years) with all Fitzpatrick skin types and in patients with immunosuppression; it is an effective treatment for actinic keratosis, cutaneous squamous cell carcinoma in situ, actinic cheilitis, hypertrophic scars, and keloids; it is useful for epidermal and dermal analgesia; drug delivery may be increased through the application of heat, pressure, or occlusion, or by using an aqueous drug solution; laser settings should be selected to ensure that channel diameter is greater than the delivered molecule; antibiotic prophylaxis is not recommended, except with impaired wound healing; antiviral prophylaxis is recommended when treating the face and genitalia; and antifungal prophylaxis is not recommended. The guideline's 15 recommendations address 5 areas of LADD use: (I) indications and contraindications; (II) parameters to report; (III) optimization of drug delivery; (IV) safety considerations; and (V) prophylaxis for bacterial, viral, and fungal infections.
CONCLUSIONS AND RELEVANCE
This systematic review and Delphi consensus approach culminated in an evidence-based clinical practice guideline for safe and effective use of LADD in a variety of applications. Future research will further improve our understanding of this novel treatment technique.
Topics: Adult; Humans; Adolescent; Pharmaceutical Preparations; Carcinoma, Squamous Cell; Antifungal Agents; Skin Neoplasms; Lasers; Antiviral Agents
PubMed: 35976634
DOI: 10.1001/jamadermatol.2022.3234 -
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 -
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 -
Journal of Pain and Symptom Management Oct 2023Ensuring patient-centered palliative care requires a comprehensive assessment of needs beginning in the initial encounter. However, there is no generally accepted guide...
CONTEXT
Ensuring patient-centered palliative care requires a comprehensive assessment of needs beginning in the initial encounter. However, there is no generally accepted guide for carrying out this multidimensional needs assessment as a first step in palliative intervention.
OBJECTIVES
To develop an expert panel-endorsed interview guide that would enable proactive and systematic Multidimensional needs Assessment in the Palliative care initial encounter (MAP).
METHODS
A preliminary version of the MAP guide was drafted based on a published literature review, published semistructured interviews with 20 patients, 20 family carers, and 20 palliative care professionals, and a nominal group process with palliative care professionals and a representative of the national patient's association. Consensus regarding its content was obtained through a modified Delphi process involving a panel of palliative care physicians from across Spain.
RESULTS
The published systematic literature review and qualitative study resulted in the identification of 55 needs, which were sorted and grouped by the nominal group. Following the Delphi process, the list of needs was reduced to 47, linked to six domains: Clinical history and medical conditions (n = 8), Physical symptoms (n = 17), Functional and cognitive status (n = 4), Psycho-emotional symptoms (n = 5), Social issues (n = 8), and Spiritual and existential concerns (n = 5).
CONCLUSION
MAP is an expert panel-endorsed semi-structured clinical interview guide for the comprehensive, systematic, and proactive initial assessment to efficiently assess multiple domains while adjusting to the needs of each patient. A future study will assess the feasibility of using the MAP guide within the timeframe of the palliative care initial encounter.
Topics: Humans; Palliative Care; Needs Assessment; Hospice and Palliative Care Nursing; Caregivers; Qualitative Research
PubMed: 37468050
DOI: 10.1016/j.jpainsymman.2023.07.011 -
Addiction (Abingdon, England) May 2023Substance use disorders (SUD) are associated with cognitive deficits that are not always addressed in current treatments, and this hampers recovery. Cognitive training...
AIMS
Substance use disorders (SUD) are associated with cognitive deficits that are not always addressed in current treatments, and this hampers recovery. Cognitive training and remediation interventions are well suited to fill the gap for managing cognitive deficits in SUD. We aimed to reach consensus on recommendations for developing and applying these interventions.
DESIGN, SETTING AND PARTICIPANTS
We used a Delphi approach with two sequential phases: survey development and iterative surveying of experts. This was an on-line study. During survey development, we engaged a group of 15 experts from a working group of the International Society of Addiction Medicine (Steering Committee). During the surveying process, we engaged a larger pool of experts (n = 54) identified via recommendations from the Steering Committee and a systematic review.
MEASUREMENTS
Survey with 67 items covering four key areas of intervention development: targets, intervention approaches, active ingredients and modes of delivery.
FINDINGS
Across two iterative rounds (98% retention rate), the experts reached a consensus on 50 items including: (i) implicit biases, positive affect, arousal, executive functions and social processing as key targets of interventions; (ii) cognitive bias modification, contingency management, emotion regulation training and cognitive remediation as preferred approaches; (iii) practice, feedback, difficulty-titration, bias modification, goal-setting, strategy learning and meta-awareness as active ingredients; and (iv) both addiction treatment work-force and specialized neuropsychologists facilitating delivery, together with novel digital-based delivery modalities.
CONCLUSIONS
Expert recommendations on cognitive training and remediation for substance use disorders highlight the relevance of targeting implicit biases, reward, emotion regulation and higher-order cognitive skills via well-validated intervention approaches qualified with mechanistic techniques and flexible delivery options.
Topics: Humans; Delphi Technique; Cognitive Training; Substance-Related Disorders; Behavior, Addictive; Consensus
PubMed: 36508168
DOI: 10.1111/add.16109 -
European Urology Oct 2023In contrast to other cancers, the concept of oligometastatic disease (OMD) has not been investigated in bladder cancer (BC).
Definition and Diagnosis of Oligometastatic Bladder Cancer: A Delphi Consensus Study Endorsed by the European Association of Urology, European Society for Radiotherapy and Oncology, and European Society of Medical Oncology Genitourinary Faculty.
BACKGROUND
In contrast to other cancers, the concept of oligometastatic disease (OMD) has not been investigated in bladder cancer (BC).
OBJECTIVE
To develop an acceptable definition, classification, and staging recommendations for oligometastatic BC (OMBC) spanning the issues of patient selection and the roles of systemic therapy and ablative local therapy.
DESIGN, SETTING, AND PARTICIPANTS
A European consensus group of 29 experts, led by the European Association of Urology (EAU), the European Society for Radiotherapy and Oncology (ESTRO), and the European Society of Medical Oncology (ESMO), and including members from all other relevant European societies, was established.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS
A modified Delphi method was used. A systematic review was used to build consensus questions. Consensus statements were extracted from two consecutive surveys. The statements were formulated during two consensus meetings. Agreement levels were measured to determine if consensus was achieved (≥75% agreement).
RESULTS AND LIMITATIONS
The first survey included 14 questions and the second survey had 12. Owing to a considerable lack of evidence, which was the major limitation, definition was limited in the context of de novo OMBC, which was further classified as synchronous OMD, oligorecurrence, and oligoprogression. A maximum of three metastatic sites, all resectable or amenable to stereotactic therapy, was proposed as the definition of OMBC. Pelvic lymph nodes represented the only "organ" not included in the definition of OMBC. For staging, no consensus on the role of F-fluorodeoxyglucose positron emission tomography/computed tomography was reached. A favourable response to systemic treatment was proposed as the criterion for selection of patients for metastasis-directed therapy.
CONCLUSIONS
A consensus statement on the definition and staging of OMBC has been formulated. This statement will help to standardise inclusion criteria in future trials, potentiate research on aspects of OMBC for which consensus was not achieved, and hopefully will lead to the development of guidelines on optimal management of OMBC.
PATIENT SUMMARY
As an intermediate state between localised cancer and disease with extensive metastasis, oligometastatic bladder cancer (OMBC) might benefit from a combination of systemic treatment and local therapy. We report the first consensus statements on OMBC drawn up by an international expert group. These statements can provide a basis for standardisation of future research, which will lead to high-quality evidence in the field.
Topics: Humans; Delphi Technique; Urology; Urinary Bladder Neoplasms; Medical Oncology; Faculty
PubMed: 37217391
DOI: 10.1016/j.eururo.2023.05.005 -
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 -
Sleep Health Dec 2023To develop and present consensus findings of the National Sleep Foundation sleep timing and variability panel regarding the impact of sleep timing variability on health...
OBJECTIVE
To develop and present consensus findings of the National Sleep Foundation sleep timing and variability panel regarding the impact of sleep timing variability on health and performance.
METHODS
The National Sleep Foundation assembled a panel of sleep and circadian experts to evaluate the scientific evidence and conduct a formal consensus and voting procedure. A systematic literature review was conducted using the NIH National Library of Medicine PubMed database, and panelists voted on the appropriateness of 3 questions using a modified Delphi RAND/UCLA Appropriateness Method with 2 rounds of voting.
RESULTS
The literature search and panel review identified 63 full text publications to inform consensus voting. Panelists achieved consensus on each question: (1) is daily regularity in sleep timing important for (a) health or (b) performance? and (2) when sleep is of insufficient duration during the week (or work days), is catch-up sleep on weekends (or non-work days) important for health? Based on the evidence currently available, panelists agreed to an affirmative response to all 3 questions.
CONCLUSIONS
Consistency of sleep onset and offset timing is important for health, safety, and performance. Nonetheless, when insufficient sleep is obtained during the week/work days, weekend/non-work day catch-up sleep may be beneficial.
Topics: Humans; Sleep; Sleep Deprivation; Consensus; Delphi Technique
PubMed: 37684151
DOI: 10.1016/j.sleh.2023.07.016