Processes for updating guidelines: protocol for a systematic review [version 1; peer review: 1 approved with reservations]

Background: National Clinical Guidelines are systematically developed statements, based on a thorough evaluation of the evidence, to assist practitioner and service users’ decisions. Clinical guidelines require updating to ensure validly of the recommendations contained within. The purpose of this systematic review is to describe the most recent guideline update processes, including prioritisation methods, used by international or national groups who provide methods guidance for developing and updating clinical guidelines. Methods: A combination of searching a pre-defined list of international and national organisations that provide methods guidance for developing and updating clinical guidelines, together with grey literature searching, will be undertaken to identify relevant handbooks. This will be supplemented by a systematic literature search of Medline (EBSCO), Embase (OVID) and The Cochrane Methodology Register. As guideline development methodology has evolved considerably, the overall search span for this systematic review will be the last 10-years (2011-2021). Publications eligible for inclusion are methodological handbooks that provide updating guidance, including prioritisation methods, for clinical practice guidelines and peer-reviewed articles that describe or have implemented updating guidance, including prioritisation methods. Using Covidence, two reviewers will independently review titles/abstracts and full texts. Where disagreements occur, discussions will be held to reach consensus and where necessary, a third reviewer will be involved. Methodological handbooks will be quality assessed (using the GIN-McMaster Guideline Development Checklist) independently by two reviewers and any disagreements will be resolved by deliberation, or if necessary, a third reviewer. Data will be extracted by one reviewer and checked for inaccuracies/omissions by a second. A narrative synthesis will be undertaken. Conclusions: Updating clinical guidelines is an iterative process that is both resource intensive and time-consuming. The findings of this systematic review will support clinical guideline developers to ensure appropriate investment of resources.</p

Commentary: is a change from the National Early Warning System (NEWS) warranted in patients with chronic respiratory conditions?

Early warning systems (EWS) were introduced in hospital systems in a number of countries including the UK (NEWS-1 and NEWS-2 UK) and Ireland (NEWS now INEWS V2) with the aim of identifying patients with acute physiological deterioration in a timely manner in order to prevent or reduce cardiopulmonary arrest, admission to the intensive care unit and premature death . Both NEWS-1 and NEWS-2 UK and INEWS are based on the ViEWS VitalPac EWS. However, INEWS uses precisely the same parameter ranges and scoring system as ViEWS while some minor modifications were made in NEWS-1 and NEWS-2 UK. These modifications included NEWS-2 UK introduced a second SpO2 scoring system for use in patients with hypercapnic respiratory failure who had a prescribed oxygen saturation requirement of 88 − 92%. The existing SpO2 scoring system (SpO2 scale 1) used in both NEWS-1 and NEWS-2 UK applies to the majority of patients. The new dedicated SpO2 scoring system (SpO2 scale 2) in NEWS-2 UK is used for patients with confirmed hypercapnic respiratory failure with the NEWS-2 UK scoring system adjusted accordingly. Previous reports have voiced concern that the SpO2 scoring system within the NEWS-1 UK and the Irish NEWS is not suitable for specific patient sub-populations, in particular those with chronic respiratory conditions including chronic obstructive pulmonary disorder (COPD). Some of these patients have a lived baseline of lower oxygen saturation levels, usually between 88 to 92% SpO2. An SpO2 below 95% triggers an alert within NEWS. This can result in excessive triggering and false alarms in this high risk sub-population of chronic respiratory patients as well as the potential for the inappropriate use of high levels of supplemental oxygen in hypercapnic patients. As part of the update to the Irish National Early Warning System (INEWS) National Clinical Guideline No.1 [see INEWS Guideline Version 2], the authors undertook a systematic review of the evidence comparing the NEWS-1 UK to modified EWSs (EWSs in which parameters are adjusted) in sub-populations of patients with chronic respiratory conditions including chronic hypoxia, chronic hypoxaemia, chronic physiological abnormalities, pulmonary fibrosis or COPD. The effectiveness of the modified EWSs in predicting mortality in this sub-population was compared to the NEWS-1 UK only.</p

Evidence synthesis summary formats for clinical guideline development group members: a mixed-methods systematic review protocol [version 1; peer review: 1 approved, 1 approved with reservations]

Introduction: Evidence syntheses, often in the form of systematic reviews, are essential for clinical guideline development and informing changes to health policies. However, clinical guideline development groups (CGDG) are multidisciplinary, and participants such as policymakers, healthcare professionals and patient representatives can face obstacles when trying to understand and use evidence synthesis findings. Summary formats to communicate the results of evidence syntheses have become increasingly common, but it is currently unclear which format is most effective for different stakeholders. This mixed-methods systematic review (MMSR) evaluates the effectiveness and acceptability of different evidence synthesis summary formats for CGDG members. Methods: This protocol follows guidance from the Joanna Briggs Institute on MMSRs and is reported according to the Preferred Reporting Items for Systematic Reviews (PRISMA)-P guideline. A comprehensive search of six databases will be performed with no language restrictions. Primary outcomes are those relating to the effectiveness and preferences for and attitudes towards the different summary formats. We will include qualitative research and randomised controlled trials. Two reviewers will perform title, abstract, and full-text screening. Independent double-extraction of study characteristics and critical appraisal items will be undertaken using a standardised form. We will use a convergent segregated approach to analyse quantitative and qualitative data separately; results will then be integrated. Discussion: The results of this systematic review will provide an overview of the effectiveness and acceptability of different summary formats for evidence synthesis findings. These findings can be helpful for those in or communicating to guideline development groups. The results can also inform the development and pilot-testing of summary formats for evidence summaries.</p

ADAPTE with modified Delphi supported developing a National Clinical Guideline: stratification of clinical risk in pregnancy

Objectives: Adaptation has been proposed as an alternative to de novo development to take advantage of existing clinical guidelines (guidelines) and reduce duplication. We describe the process of incorporating a modified Delphi method to reach formal consensus and inform locally relevant clinical recommendations during the development, through the ADAPTE process, of the Irish National Clinical Guideline No. 23 Stratification of Clinical Risk in Pregnancy. Methods: A systematic search of guideline repositories, websites, and bibliographic databases was conducted. Quality appraisal was undertaken using AGREE II. Risk factors indicating the need for additional care were identified and extracted from high-quality guidelines. A three-round modified Delphi panel comprising healthcare stakeholders, was convened to agree and tailor risk factors. Results: Of seven relevant international guidelines identified, three were considered high quality and contained a combined 59 risk factors potentially suitable for adaptation. Following the three-round Delphi process, 49 risk factors were included in the final guideline. Excluded risk factors were generally considered to be too broad to be useful for the Irish context. Conclusion: We believe that a formal consensus technique included within the ADAPTE process increased the rigor and transparency of this process and ensured the inclusion of more locally relevant risk factors.</p

The efectiveness and acceptability of evidence synthesis summary formats for clinical guideline development groups: a mixed-methods systematic review

Introduction: Clinical guideline development often involves a rigorous synthesis of evidence involving multidisciplinary stakeholders with diferent priorities and knowledge of evidence synthesis; this makes communicating fndings complex. Summary formats are typically used to communicate the results of evidence syntheses; however, there is little consensus on which formats are most efective and acceptable for diferent stakeholders.  Methods: This mixed-methods systematic review (MMSR) aimed to evaluate the efectiveness and acceptability (e.g. preferences and attitudes and preferences towards) of evidence synthesis summary formats for GDG members. We followed the PRISMA 2020 guideline and Joanna Briggs Institute Manual for Evidence Synthesis for MMSRs. We searched six databases (inception to April 20, 2021) for randomised controlled trials (RCTs), RCTs with a qualitative component, and qualitative studies. Screening, data extraction, and quality appraisal were performed in duplicate. Qualitative fndings were synthesised using meta-aggregation, and quantitative fndings are described narratively.  Results: We identifed 17,240 citations and screened 54 full-text articles, resulting in 22 eligible articles (20 unique studies): 4 articles reported the results of 5 RCTs, one of which also had a qualitative component. The other 18 articles discussed the results of 16 qualitative studies. Therefore, we had 5 trials and 17 qualitative studies to extract data from. Studies were geographically heterogeneous and included a variety of stakeholders and summary formats. All 5 RCTs assessed knowledge or understanding with 3 reporting improvement with newer formats. The qualitative analysis identifed 6 categories of recommendations: ‘presenting information’, ‘tailoring information’ for end users, ‘trust in producers and summary’, ‘knowledge required’ to understand fndings, ‘quality of evidence’, and properly ‘contextualising information’. Across these categories, the synthesis resulted in 126 recommendations for practice. Nine recommendations were supported by both quantitative and qualitative evidence and 116 by only qualitative. A majority focused on how to present information (n = 64) and tailor content for diferent end users (n = 24).  Conclusions: This MMSR provides guidance on how to improve evidence summary structure and layout. This can be used by synthesis producers to better communicate to GDGs. Study fndings will inform the co-creation of evidence summary format prototypes based on GDG member’s needs.    Trial registration The protocol for this project was previously published, and the project was preregistered on Open Science Framework (Clyne and Sharp, Evidence synthesis and translation of fndings for national clinical guideline development: addressing the needs and preferences of guideline development groups, 2021; Sharp and Clyne, Evidence synthesis summary formats for decision-makers and Clinical Guideline Development Groups: A mixed-methods systematic review protocol, 2021).</p

Evidence synthesis summary formats for clinical guideline development group members: a mixed-methods systematic review protocol [version 2; peer review: 2 approved]

Introduction: Evidence syntheses, often in the form of systematic reviews, are essential for clinical guideline development and informing changes to health policies. However, clinical guideline development groups (CGDG) are multidisciplinary, and participants such as policymakers, healthcare professionals and patient representatives can face obstacles when trying to understand and use evidence synthesis findings. Summary formats to communicate the results of evidence syntheses have become increasingly common, but it is currently unclear which format is most effective for different stakeholders. This mixed-methods systematic review (MMSR) evaluates the effectiveness and acceptability of different evidence synthesis summary formats for CGDG members. Methods: This protocol follows guidance from the Joanna Briggs Institute on MMSRs and is reported according to the Preferred Reporting Items for Systematic Reviews (PRISMA)-P guideline. A comprehensive search of six databases will be performed with no language restrictions. Primary outcomes are those relating to the effectiveness and preferences for and attitudes towards the different summary formats. We will include qualitative research and randomised controlled trials. Two reviewers will perform title, abstract, and full-text screening. Independent double-extraction of study characteristics and critical appraisal items will be undertaken using a standardised form. We will use a convergent segregated approach to analyse quantitative and qualitative data separately; results will then be integrated. Discussion: The results of this systematic review will provide an overview of the effectiveness and acceptability of different summary formats for evidence synthesis findings. These findings can be helpful for those in or communicating to guideline development groups. The results can also inform the development and pilot-testing of summary formats for evidence summaries.</p