The Influence of Activity Roles and Use of a Structured Framework on Developing Hematology Clinical Practice Guidelines
Authors: Li Shelly-Anne , Alexander Paul , Reljic Tea , Cuker Adam , Robby Nieuwlaat , Wiercioch Wojtek , Guyatt Gordon , Schünemann Holger , Djulbegovic Benjamin 
Published: October 2019

Abstract
Introduction: The decision-making process during clinical recommendations development is central for producing high-quality hematology clinical practice guidelines, but little is known about how the activity roles of guidelines panelists (e.g., chair, methodologist, content expert, etc.) and the use of decision-making frameworks influence evidence-informed decisions when making clinical recommendations.
Objective: To explore and describe the activity roles of panelists in hematology guidelines panels, the application of a structured decision-making framework, and the factors being considered by panels when making clinical recommendations.
Methods: We conducted conventional and summative qualitative analyses on the decision-making process of 9 audio-recorded panels convened by the American Society of Hematology (ASH) to develop guidelines for the management of the following conditions: heparin-induced thrombocytopenia, thrombophilia, optimal management of anticoagulation therapy, venous thromboembolism (VTE) in pregnancy, in pediatric populations, in patients with cancer, in non-surgical patients, in surgical patients, and treatment in VTE. Each panel developed final recommendations through group consensus during face-to-face meetings using GRADE (Grading of Recommendations Assessment, Development, and Evaluation)'s Evidence-to-Decision (EtD) framework. For each recommendation, panels made explicit judgments for each criterion in the framework. We analyzed GRADE and non-GRADE criteria that were used to make each recommendation, as well as the activity roles of each panelist.
Results: GRADE criteria occupied 95% of all deliberations. Over half (51.1%) of the panel deliberations concerned research evidence related to the clinical effects of a treatment or practice, followed by discussion on resource use and costs (16.7%), feasibility and acceptability (13.5%), risks of benefits and harms (8.8%), equity (4.0%), and values and preferences (1.0%). Non-GRADE criteria represented the remaining 5% of the discussions (transparent communication on the decision-making process when making recommendations, legal implications, political context, and clinical experience). Chairs and co-chairs actively led and facilitated all discussion topics; they contributed to over half of the deliberations (55.2%). The remaining deliberations were from panelists (38.1%), systematic review team members (5.0%), and patient representatives (1.0%).
Conclusions: The application of the EtD framework provided a highly structured decision-making process when making clinical recommendations for hematologic conditions. Chairs and co-chairs tend to actively lead the panel discussions, which contributed to framework adherence. The optimal role of chairs and co-chairs versus other panelists need to be further investigated. Future studies should examine how the decision-making process of treatment and interventions for hematologic conditions differ between guidelines panels that use and do not use a structured framework to develop clinical practice recommendations.

Disclosures
Cuker: Genzyme: Consultancy; Synergy: Consultancy; Spark Therapeutics: Research Funding; Kedrion: Membership on an entity's Board of Directors or advisory committees.