Establishing clinical remission criteria for giant cell arteritis: Results of a Delphi exercise carried out by an expert panel of the Japan Research Committee of the Ministry of Health, Labour, and Welfare for Intractable Vasculitis.

OBJECTIVE: To develop a proposal for giant cell arteritis remission criteria in order to implement a treat-to-target algorithm. METHODS: A task force consisting of 10 rheumatologists, 3 cardiologists, 1 nephrologist, and 1 cardiac surgeon was established in the Large-vessel Vasculitis Group of the Japanese Research Committee of the Ministry of Health, Labour and Welfare for Intractable Vasculitis to conduct a Delphi survey of remission criteria for giant cell arteritis. The survey was circulated among the members over four reiterations with four face-to-face meetings. Items with a mean score of ≥4 were extracted as items for defining remission criteria. RESULTS: An initial literature review yielded a total of 117 candidate items for disease activity domains and treatment/comorbidity domains of remission criteria, of which 35 were extracted as disease activity domains (systematic symptoms, signs and symptoms of cranial and large-vessel area, inflammatory markers, and imaging findings). For the treatment/comorbidity domain, ≤5 mg/day of prednisolone 1 year after starting glucocorticoids was extracted. The definition of achievement of remission was the disappearance of active disease in the disease activity domain, normalization of inflammatory markers, and ≤5 mg/day of prednisolone. CONCLUSION: We developed proposals for remission criteria to guide the implementation of a treat-to-target algorithm for giant cell arteritis.

Assessing the Value of Provider-Facing Digital Health Technologies Used in Chronic Disease Management: Toward a Value Framework Based on Multistakeholder Perceptions.

OBJECTIVES: Hardly any value frameworks exist that are focused on provider-facing digital health technologies (DHTs) for managing chronic disease with diverse stakeholder participation in their creation. Our study aimed to 1) understanding different stakeholder opinions on where value lies in provider-facing technologies and 2) create a comprehensive value assessment framework for DHT assessment. METHODS: Mixed-methods comprising both primary and secondary evidence were used. A scoping review enabled a greater understanding of the evidence base and generated the initial indicators. Thirty-four indicators were proposed within 6 value domains: health inequalities (3), data rights and governance (6), technical and security characteristics (6), clinical characteristics (7), economic characteristics (9), and user preferences (3). Subsequently, a 3-round Web-Delphi was conducted to rate the indicators' importance in the context of technology assessment and determine whether there was consensus. RESULTS: The framework was adapted to 45 indicators based on participant contributions in round 1 and delivered 16 stable indicators with consensus after rounds 2 and 3. Twenty-nine indicators showed instability and/or dissensus, particularly the data rights domain, in which all 5 indicators were unstable, showcasing the novelty of the concept of data rights. Significant instability between important and very important ratings was present within stakeholder groups, particularly clinicians and policy experts, indicating they were unsure how different aspects should be valued. CONCLUSIONS: Our study provides a comprehensive value assessment framework for assessing provider-facing DHTs incorporating diverse stakeholder perspectives. Instability for specific indicators was expected due to the novelty of data and analytics integration in health technologies and their assessment. Further work is needed to ensure that, across all types of stakeholders, there is a clear understanding of the potential impacts of provider-facing DHTs. HIGHLIGHTS: Current health technology assessment (HTA) methods may not be well suited for evaluating digital health technologies (DHTs) because of their complexity and wide-ranging impact on the health system.This article adds to the literature by exploring a wide range of stakeholder opinions on the value of provider-facing DHTs, creating a holistic value framework for these technologies, and highlighting areas in which further discussions are needed to align stakeholders on DHTs' value attributes.A Web-based Delphi co-creation approach was used involving key stakeholders from throughout the digital health space to generate a widely applicable value framework for assessing provider-facing DHTs. The stakeholders include patients, health care professionals, supply-side actors, decision makers, and academia from the United States, United Kingdom, and Germany.High levels of instability among stakeholders and value domains are demonstrated, indicating the novelty of assessing provider-facing DHTs and their impact on the health system.

Establishing clinical remission criteria and the framework of a treat-to-target algorithm for Takayasu arteritis: Results of a Delphi exercise carried out by an expert panel of the Japan Research Committee of the Ministry of Health, Labour and Welfare for intractable vasculitis.

OBJECTIVES: To develop a proposal for remission criteria and a framework for a treat-to-target (T2T) algorithm for Takayasu arteritis (TAK). METHODS: A study group of the large-vessel vasculitis group of the Japanese Research Committee of the Ministry of Health, Labour and Welfare for Intractable Vasculitis consists of 10 rheumatologists, 5 cardiologists, 1 nephrologist, 1 vascular surgeon, 1 cardiac surgeon, and 2 paediatric rheumatologists. A Delphi survey of remission criteria items was circulated among the study group over four reiterations. To develop the T2T algorithm, the study group conducted four face-to-face meetings and two rounds of Delphi together with three patients. RESULTS: Initial literature review resulted in a list of 117 candidate items for remission criteria, of which 56 items with a mean score of ≥4 (0-5) were extracted including disease activity domains and treatment/comorbidity domains. The study group provided six overarching principles for the T2T algorithm, two recommendations on treatment goals, five on evaluation of disease activity and imaging findings including positron emission tomography-computed tomography, and two on treatment intensification. CONCLUSIONS: We developed a T2T algorithm and proposals for standardised remission criteria by means of a Delphi exercise. These will guide future evaluation of different TAK treatment regimens.

Consensus-based semi-quantitative ultrasound scoring system for gout lesions: Results of an OMERACT Delphi process and web-reliability exercise.

OBJECTIVE: This study aimed to develop (1) a new ultrasound definition for aggregates and (2) a semi-quantitative ultrasound scoring system (0-3) for tophus, double contour and aggregates. Furthermore, the intra- and inter-reader reliabilities of both the re-defined aggregates and the semi-quantitative scoring system were assessed using static image exercises. METHODS: Thirty-seven rheumatologists were invited. A Delphi process was used for re-defining aggregates and for selecting a semi-quantitative scoring system with >75% agreement obligate for reaching consensus. Subsequently, a web-based exercise on static ultrasound images was conducted in order to assess the reliability of both the re-defined aggregates and the semi-quantitative scoring system. RESULTS: Twenty rheumatologists contributed to all rounds of the Delphi and image exercises. A consensual re-definition of aggregates was obtained after three Delphi rounds but needed an overarching principle for scoring aggregates in patients. A consensus-based semi-quantitative ultrasound scoring system for gout lesions was developed after two Delphi rounds. The re-definition of aggregates showed good intra- and inter-reader reliability (κ-values 0.71 and 0.61). The reliabilities of the scoring system were good for all lesions with slightly higher intra-reader (κ-values 0.74-0.80) than inter-reader reliabilities (κ-values 0.61-0.67). CONCLUSION: A re-definition of aggregates was obtained with a good reliability when assessing static images. The first consensus-based semi-quantitative ultrasound scoring system for gout-specific lesions was developed with good inter- and intra-reader reliability for all lesions when tested in static images. The next step is to assess the reliabilities when scoring lesions in patients.

Development of indicators to assure quality of disability evaluation based on the International Classification of Functioning, Disability, and Health in Taiwan: a Delphi consensus.

Purpose: To develop a set of quality indicators (QIs) for managing the International Classification of Functioning, Disability, and Health-based disability evaluation system in Taiwan.Method: Using a three-round Delphi exercise, 20 representatives from the social welfare associations for people with disability completed the consensus process. Questionnaire 1 comprised 52 potentially important factors relevant to good services for persons with disabilities in the system. An additional nine items were added to questionnaires 2 and 3. The responders rated the importance of each item using a 5-point Likert scale. The set of QIs for managing the system comprised items that obtained high consensus and a mean score ≥4.5 found in round 3.Results: Those QIs included a composite of measures about a comfortable and barrier-free assessment room, on-site assistance (being important for client access and safety), client's privacy, rights protection, and satisfaction, convenient service, attitude of staff (towards client centeredness), accuracy of report (system effectiveness), and competent staff (system efficiency). Spearman's rho (mean ± standard deviation) of round 3 was 0.79 ± 0.09, and Cronbach's α = 0.90.Conclusions: This set of QIs is suitable for managing the system serving people with disabilities. It is feasible in practice and scientifically acceptable, but further validation is needed.Implications for rehabilitationWith this study, we were able to develop a set of quality indicators for managing the International Classification of Functioning, Disability and Health-based disability evaluation system.The set of quality indicators included a composite of measures about a comfortable and barrier-free assessment room and on-site assistance; client's privacy, rights protection, and satisfaction, convenient service, attitude of staff; accuracy of report, and competent staff.These quality indicators foster client-centeredness, access, safety, system effectiveness and efficiency, feasibility, and science; and are relevant to managing a system that is intended to serve people with disabilities.

A Delphi study and ranking exercise to support commissioning services: future delivery of Thrombectomy services in England.

BACKGROUND: Intra-arterial thrombectomy is the gold standard treatment for large artery occlusive stroke. However, the evidence of its benefits is almost entirely based on trials delivered by experienced neurointerventionists working in established teams in neuroscience centres. Those responsible for the design and prospective reconfiguration of services need access to a comprehensive and complementary array of information on which to base their decisions. This will help to ensure the demonstrated effects from trials may be realised in practice and account for regional/local variations in resources and skill-sets. One approach to elucidate the implementation preferences and considerations of key experts is a Delphi survey. In order to support commissioning decisions, we aimed using an electronic Delphi survey to establish consensus on the options for future organisation of thrombectomy services among physicians with clinical experience in managing large artery occlusive stroke. METHODS: A Delphi survey was developed with 12 options for future organisation of thrombectomy services in England. A purposive sampling strategy established an expert panel of stroke physicians from the British Association of Stroke Physicians (BASP) Clinical Standards and/or Executive Membership that deliver 24/7 intravenous thrombolysis. Options with aggregate scores falling within the lowest quartile were removed from the subsequent Delphi round. Options reaching consensus following the two Delphi rounds were then ranked in a final exercise by both the wider BASP membership and the British Society of Neuroradiologists (BSNR). RESULTS: Eleven stroke physicians from BASP completed the initial two Delphi rounds. Three options achieved consensus, with subsequently wider BASP (97%, n = 43) and BSNR members (86%, n = 21) assigning the highest approval rankings in the final exercise for transferring large artery occlusive stroke patients to nearest neuroscience centre for thrombectomy based on local CT/CT Angiography. CONCLUSIONS: The initial Delphi rounds ensured optimal reduction of options by an expert panel of stroke physicians, while subsequent ranking exercises allowed remaining options to be ranked by a wider group of experts within stroke to reach consensus. The preferred implementation option for thrombectomy is investigating suspected acute stroke patients by CT/CT Angiography and secondary transfer of large artery occlusive stroke patients to the nearest neuroscience (thrombectomy) centre.