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Quality Standards Summit 2018


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REG Summit WG 2018

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Quality Standards Summit 2018

  1. 1. REG Summit 2018 Amsterdam, 22nd March 2018 Quality Standards Working Group Meeting
  2. 2. Agenda • Brief summary of past achievements • Next steps o Manuscripts o Tool dissemination • Potential other future activities
  3. 3. Attendees • N Roche (chair)
  4. 4. Past achievements • RELEVANT: REal Life Evidence AssessmeNt Tool o Phase I: Assess the quality of the asthma comparative effectiveness literature to identify evidence for consideration by future guideline developers o Phase II: Develop implementable tools to facilitate quality appraisal of published real-world evidence
  5. 5. Creating RELEVANT • Development and testing of the quality assessment tool was across 6 key phases o Phase I: Review of the literature – Six publications on quality parameters for non-RCT CER were identified, of which two incorporated the key principles. o Phase II: Initial tool creation – Quality domains and sub-items mapped from publications – 43-item checklist created o Phase III: Taskforce review and feedback – Recommendation to reduce the number of sub-items – 25 quality sub-items across 7 domains
  6. 6. Creating RELEVANT • Cont.: o Phase IV: Pilot application of the quality assessment tool – Two groups of nine participants used the tool to appraise 3 papers each – Inter rater agreement varied across sub-items – Redundancies removed and careful rephrasing. Secondary items to remain hidden until fulfilment of primary sub-items is confirmed o Phase V: Extended pilot – 22 participants, in 3 groups, used the tool to appraise two papers each – Improvement in inter-rater agreement – Tool refined to 21 sub-items – Final rephrasing implemented o Phase VI: Development of an online tool
  7. 7. RELEVANT: The final tool PRIMARY CRITERIA 1. Background 1.1. Clearly stated research question 2. Design 2.1 Population defined 2.2. Comparison groups defined and justified 3. Measures 3.1. (If relevant), exposure (e.g. treatment) is clearly defined 3.2. Primary outcomes defined 4. Analysis 4.1. Potential confounders are addressed 4.2. Study groups are compared at baseline 5. Results 5.1. Results are clearly presented for all primary and secondary endpoints as well as confounders 6. Discussion/ Interpretation 6.1. Results consistent with known information or if not, an explanation is provided 6.2 The clinical relevance of the results is discussed 7. Conflict of interests 7.1. Potential conflicts of interest, including study funding, are stated SECONDARY CRITERIA 1. Background 1.1. The research is based on a review of the background literature (ideal standard is a systematic review) 2. Design 2.1. Evidence of a priori design, e.g. protocol registration in a dedicated website 2.2 Population justified 2.3 The datasource (or database), as described, contains adequate exposures (if relevant) and outcome variables to answer the research question 2.4 Setting justified 3. Measures 3.1 Sample size / Power pre-specified 4. Analysis NO SECONDARY CRITERIA 5. Results 5.1. Flow chart explaining all exclusions and individuals screened or selected at each stage of defining the final sample 5.2. The authors describe the statistical uncertainty of their findings (e.g. p-values, confidence intervals) 5.3. The extent of missing data is reported 6. Discussion/ Interpretation 6.1. Possible biases and/or confounding factors described 7. Conflict of interests NO SECONDARY CRITERIA
  8. 8. Testing RELEVANT • 21 PICOT questions identified o relevant to asthma management o limited ability of available RCTs o potential for observational studies to provide answers • 4 selected as priority questions, literature search performed and 46 papers identified o Question 1: Influence of adherence/persistence on treatment effectiveness – 24 papers o Question 2: Influence of smoking on asthma outcomes and treatment effectiveness – 7 papers o Question 3:The impact of inhaler device on asthma outcomes – 3 papers o Question 4: Relationship between particle size of maintenance therapy and asthma outcomes – 12 papers For all PICOT questions, assessed observational studies yielded results with possible impact on clinical practice in areas where similar evidence from RCTs is lacking.
  9. 9. Conclusions •RELEVANT is a user-friendly quality appraisal tool comprising 21 quality criteria (11 primary; 10 secondary) across seven core quality domains. •It is the first of its kind to support quality appraisal of published research and to have been developed through iterative feedback derived from pilot implementation and inter-rater agreement evaluation.
  10. 10. Two manuscripts in review with EAACI • Manuscript 1: o Quality standards in respiratory real-life effectiveness research: report from the Respiratory Effectiveness Group – European Academy of Allergy and Clinical Immunology Task Force • Manuscript 2: o The REal Life EVidence AssessmeNt Tool (RELEVANT): development of a novel quality assurance asset
  11. 11. Next steps • Publication of papers o Decision on third paper describing the literature review • Promoting and using RELEVANT: o Make the tool available o Advertise and promote it Where and how?
  12. 12. Other research ideas? • How do we set priorities in quality standards research? • How to we ensure these priorities are pursued? • What are the two most important projects to push forwards?
  13. 13. Any other business?