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

ABSTRACT 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.

A study protocol for the development of a SPIRIT extension for trials conducted using cohorts and routinely collected data (SPIRIT-ROUTINE)

Background: Protocols are an essential document for conducting randomised controlled trials (RCTs). However, the completeness of the information provided is often inadequate. To help improve the content of trial protocols, an international group of stakeholders published the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) Initiative in 2013. Presently, there is increasing use of cohorts and routinely collected data (RCD) for RCTs because these data have the potential to improve efficiencies by facilitating recruitment, simplifying, and reducing the cost of data collection. Reporting guidelines have been shown to improve the quality of reporting, but there is currently no specific SPIRIT guidance on protocols for trials conducted using cohorts and RCD. This protocol outlines steps for developing SPIRIT-ROUTINE, which aims to address this gap by extending the SPIRIT guidance to protocols for trials conducted using cohorts and RCD. Methods: The development of the SPIRIT-ROUTINE extension comprises five stages. Stage 1 consists of a project launch and a meeting to finalise the membership of the steering group and scope of the extension. In Stage 2, a rapid review will be performed to identify possible modifications to the original SPIRIT 2013 checklist. Other key reporting guidelines will be reviewed to identify areas where additional items may be needed, such as the Consolidated Standards of Reporting Trials (CONSORT) extension for trials conducted using cohorts and RCD (CONSORT-ROUTINE). Stage 3 will involve an online Delphi exercise, consisting of two rounds and involving key international stakeholders to gather feedback on the preliminary checklist items. In Stage 4, a consensus meeting of the SPIRIT-ROUTINE steering group will finalise the items to include in the extension. Stage 5 will involve the publication preparation and dissemination of the final checklist. Conclusion: The SPIRIT-ROUTINE extension will contribute to improving design of trials using cohorts and RCD and transparency of reporting.

Development and validation of an algorithm to assist in the interpretation of the electrocardiogram

Funding Acknowledgements Type of funding sources: None. Background and Purpose Interpretation of the electrocardiogram (ECG) is often poorly performed, affecting time critical patient care. There are no reliable methods that consistently bridge the gap between novices and competency. However, the development of a framework allowing a step-wise approach to interpret the ECG based on relevant signals might help. Indeed, in addition to expert teaching, a pilot study of this algorithm significantly improves sustained ECG interpretation in medical students. This study aimed to validate the ECG algorithm tool by confirming the appropriateness of its step-wise components through expert cardiologists. Methods A Modified Delphi Exercise protocol was used. Cardiologists were invited to participate in a questionnaire through an online survey tool. Expert participants evaluated each stage of the ECG algorithm through multiple levels of agreement and explained their decision making with the option of free-text comments. These were collated and analysed by the four authors and changes subsequently made. The process was repeated, with evaluation of the changes from each round until a predetermined level of agreement was achieved. Results This Modified Delphi Exercise produced two rounds. Overall, 55 responses from experts was achieved (first round = 33, round two = 22). The average agreement in round one was 85.8% with 25 changes from 124 comments. Round two achieved 93.4% agreement with 12 changes from 57 comments. After discussion by four authors, a consensus was reached and a final algorithm was achieved. Figure 1 shows the bradycardia section of the final algorithm (tachycardia and ST/T-wave/ischaemia sections not shown). Conclusions We have validated an ECG algorithm through a rigorous development and review process in a multi-institutional and multi-national Modified Delphi study. The completed expert reviewed algorithm may be a safe, informative tool for novice users to improve ECG interpretation. However, further validation in user groups is now mandated to refine the tool. Abstract Figure 1- Algorithm one of three

Technical capacities needed to implement the WHO’s primary eye care package for Africa: results of a Delphi process

ObjectiveThe aim of the study was to establish the technical capacities needed to deliver the WHO African Region’s primary eye care package in primary healthcare facilities.DesignA two-round Delphi exercise was used to obtain expert consensus on the technical complexity of each component of the package and the technical capacities needed to deliver them using Gericke’s framework of technical feasibility. The panel comprised nine eyecare experts in primary eyecare in sub-Saharan Africa. In each round panel members used a 4-point Likert scale to indicate their level of agreement. Consensus was predefined as ≥70% agreement on each statement. For round 1, statements on technical complexity were identified through a literature search of primary eyecare in sub-Saharan Africa from January 1980 to April 2018. Statements for which consensus was achieved were included in round 2, and the technical capacities were agreed.ResultsTechnical complexity statements were classified into four broad categories: intervention characteristics, delivery characteristics, government capacity requirements and usage characteristics. 34 of the 38 (89%) statements on health promotion and 40 of the 43 (93%) statements on facility case management were considered necessary technical capacities for implementation.ConclusionThis study establishes the technical capacities needed to implement the WHO Africa Office primary eye care package, which may be generalisable to countries in sub-Saharan Africa.

Anti-interleukin 5 therapies failure criteria in severe asthma: a Delphi-consensus study

Background: Current practices for assessing response to anti-interleukin 5/R treatment in severe asthma patients are heterogeneous. The objective of this study was to achieve an expert consensus defining failure criteria for anti-interleukin 5/R treatment in severe asthma patients. Methods: Experts were invited to a 5-round Delphi exercise if they were pulmonologists managing ⩾30 patients at a nationally recognized severe asthma expert centre. Following two rounds of statement-generating brainstorming, the expert panel ranked each statement according to a 5-point Likert-type scale during three additional rounds. Positive consensus was considered achieved when ⩾80% of experts agreed with a statement with >50% strong agreement and <15% disagreement. Results: Twenty experts participated in the study. All experts agreed that predefined treatment goals defining effectiveness should be personalized during shared decision making via a patient contract. Treatment failure was defined as (1) absence of a reduction in exacerbation rates by ⩾25% or (2) absence of a reduction in oral corticosteroid therapy by ⩾25% of the initial dosage or (3) occurrence of emergency room visits or hospitalizations after 6 months of treatment. Treatment failure should result in discontinuation. For partial responders, treatment discontinuation was not recommended unless an alternative from another therapeutic class exists and should be discussed in a multidisciplinary consultation. Conclusion: The present study provides objective criteria for anti IL5 or IL5R failure in severe asthma and suggests consensus based guidelines for prescription, evaluation and discontinuation decision-making.

Reporting items for capillaroscopy in clinical research on musculoskeletal diseases: a systematic review and international Delphi consensus

Objectives The level of detail included when describing nailfold videocapillaroscopy (NVC) methods varies among research studies, making interpretation and comparison of results challenging. The overarching objective of the present study was to seek consensus on the reporting standards in NVC methodology for clinical research in rheumatic diseases and to propose a pragmatic reporting checklist. Methods Based on the items derived from a systematic review focused on this topic, a three-step web-based Delphi consensus on minimum reporting standards in NVC was performed among members of the European League against Rheumatism (EULAR) Study Group on Microcirculation in Rheumatic Diseases and the Scleroderma Clinical Trials Consortium. Results A total of 319 articles were selected by the systematic review, and 46 items were proposed in the Delphi process. This Delphi exercise was completed by 80 participants from 31 countries, including Australia and countries within Asia, Europe, North America and South America. Agreement was reached on items covering three main areas: patient preparation before NVC (15 items), device description (5 items) and examination details (13 items). Conclusion Based on the available evidence, the description of NVC methods was highly heterogeneous in the identified studies and differed markedly on several items. A reporting checklist of 33 items, based on practical suggestions made (using a Delphi process) by international participants, has been developed to provide guidance to improve and standardize the NVC methodology to be applied in future clinical research studies.

Identifying major policy challenges and policy interventions via expert methods

This paper presents the application of expert decision methods for the formulation and prioritization of the long-term economic, social and environmental policies in the Slovak Republic. The Partnership Agreement for the Slovak Republic (PA) is an underlying strategy for investments from the European Structural and Investment Funds (ESIF) in the period 2021-2027. Policies implemented under the PA will allocate €13.4b on four policy objectives. This paper concentrates on the policy objective 4 ‘Social development’. The authors co-operated with the Deputy Prime Minister Office and assembled panels of top Slovak experts on social and economic issues. The Delphi and Analytical hierarchy process (AHP) methods were combined for analyzing major development challenges and eliciting policy priorities. The methods combined the bottom-up and top-down approaches to policy making. Nine potential policy measures in three policy areas emerged from the Delphi exercise. The AHP exercise applied three criteria (relevance, urgency and feasibility) to rank the abovementioned measures within three policy areas. As for the Policy Area 1 (Labour market, employment, training and institutions) the measure 4.1.1 ‘Improving access to employment and modernizing institutions and services on labour market’ clearly dominated over the measure 4.1.2 ‘Supporting a better work-life balance’. The measure 4.2.2 ‘Equal access to quality and inclusive education’ emerged substantially more important than measures 4.2.1 ‘Improving the quality and effectiveness of education and training systems’ and 4.2.3 ‘Support to life-long learning’ in the Policy Area 2 ‘Education and skills’. Finally, measures 4.3.2 ‘Supporting social and economic integration of marginalized Roma communities’ and 4.3.3 ‘Ensuring equal access to healthcare including primary care’ received the highest ranks in the Policy Area 3 ‘Health and social services’.

Critical review of multimorbidity outcome measures suitable for low-income and middle-income country settings: perspectives from the Global Alliance for Chronic Diseases (GACD) researchers

ObjectivesThere is growing recognition around the importance of multimorbidity in low-income and middle-income country (LMIC) settings, and specifically the need for pragmatic intervention studies to reduce the risk of developing multimorbidity, and of mitigating the complications and progression of multimorbidity in LMICs. One of many challenges in completing such research has been the selection of appropriate outcomes measures. A 2018 Delphi exercise to develop a core-outcome set for multimorbidity research did not specifically address the challenges of multimorbidity in LMICs where the global burden is greatest, patterns of disease often differ and health systems are frequently fragmented. We, therefore, aimed to summarise and critically review outcome measures suitable for studies investigating mitigation of multimorbidity in LMIC settings.SettingLMIC.ParticipantsPeople with multimorbidity.Outcome measuresIdentification of all outcome measures.ResultsWe present a critical review of outcome measures across eight domains: mortality, quality of life, function, health economics, healthcare access and utilisation, treatment burden, measures of ‘Healthy Living’ and self-efficacy and social functioning.ConclusionsStudies in multimorbidity are necessarily diverse and thus different outcome measures will be appropriate for different study designs. Presenting the diversity of outcome measures across domains should provide a useful summary for researchers, encourage the use of multiple domains in multimorbidity research, and provoke debate and progress in the field.