Guideline-based quality assurance: a conceptual framework for the definition of key elements.

BACKGROUND: In 2017, the European Commission's Joint Research Centre (JRC) started developing a methodological framework for a guideline-based quality assurance (QA) scheme to improve cancer quality of care. During the first phase of the work, inconsistency emerged about the use of terminology for the definition, the conceptual underpinnings and the way QA relates to health questions that are answered in guidelines. The objective of this final of three articles is to propose a conceptual framework for an integrated approach to guideline and QA development and clarify terms and definitions for key elements. This work will inform the upcoming European Commission Initiative on Colorectal Cancer (ECICC). METHODS: A multidisciplinary group of 23 experts from key organizations in the fields of guideline development, performance measurement and quality assurance participated in a mixed method approach including face-to-face dialogue and several rounds of virtual meetings. Informed by results of a systematic literature review that indicated absence of an existing framework and practical examples, we first identified the relations of key elements in guideline-based QA and then developed appropriate concepts and terminology to provide guidance. RESULTS: Our framework connects the three key concepts of quality indicators, performance measures and performance indicators integrated with guideline development. Quality indicators are constructs used as a guide to monitor, evaluate, and improve the quality of the structure, process and outcomes of healthcare services; performance measures are tools that quantify or describe measurable elements of practice performance; and performance indicators are quantifiable and measurable units or scores of practice, which should be guided by guideline recommendations. CONCLUSIONS: The inconsistency in the way key terms of QA are used and defined has confused the field. Our conceptual framework defines the role, meaning and interactions of the key elements for improving quality in healthcare. It directly builds on the questions asked in guidelines and answered through recommendations. These findings will be applied in the forthcoming ECICC and for the future updates of ECIBC. These are large-scale integrated projects aimed at improving healthcare quality across Europe through the development of guideline-based QA schemes; this will help in implementing and improving our approach.

Bringing two worlds closer together: a critical analysis of an integrated approach to guideline development and quality assurance schemes.

BACKGROUND: Although quality indicators are frequently derived from guidelines, there is a substantial gap in collaboration between the corresponding parties. To optimise workflow, guideline recommendations and quality assurance should be aligned methodologically and practically. Learning from the European Commission Initiative on Breast Cancer (ECIBC), our objective was to bring the key knowledge and most important considerations from both worlds together to inform European Commission future initiatives. METHODS: We undertook several steps to address the problem. First, we conducted a feasibility study that included a survey, interviews and a review of manuals for an integrated guideline and quality assurance (QA) scheme that would support the European Commission. The feasibility study drew from an assessment of the ECIBC experience that followed commonly applied strategies leading to separation of the guideline and QA development processes. Secondly, we used results of a systematic review to inform our understanding of methodologies for integrating guideline and QA development. We then, in a third step, used the findings to prepare an evidence brief and identify key aspects of a methodological framework for integrating guidelines QA through meetings with key informants. RESULTS: Seven key themes emerged to be taken into account for integrating guidelines and QA schemes: (1) evidence-based integrated guideline and QA frameworks are possible, (2) transparency is key in clearly documenting the source and rationale for quality indicators, (3) intellectual and financial interests should be declared and managed appropriately, (4) selection processes and criteria for quality indicators need further refinement, (5) clear guidance on retirement of quality indicators should be included, (6) risks of an integrated guideline and QA Group can be mitigated, and (7) an extension of the GIN-McMaster Guideline Development Checklist should incorporate QA considerations. DISCUSSION: We concluded that the work of guideline and QA developers can be integrated under a common methodological framework and we provided key findings and recommendations. These two worlds, that are fundamental to improving health, can both benefit from integration.

Control of Severe, Life-Threatening External Bleeding in the Out-of-Hospital Setting: A Systematic Review.

OBJECTIVE: Trauma, with resultant bleeding, is a significant cause of morbidity and mortality throughout the world; however, the best possible method of bleeding control by immediate responders is unknown. We performed a systematic review of the effectiveness of treatment modalities for severe, life-threatening external bleeding in the out-of-hospital first aid setting. Methods: We followed the Cochrane Handbook for Systematic Reviews of Interventions methodology and report results according to PRISMA guidelines. We included randomized controlled trials, non-randomized comparative studies and case series investigating adults and children with severe, life-threatening external bleeding who were treated with therapies potentially suitable for first aid providers. We assessed the certainty of the evidence and risk of bias. Outcomes were prioritized by first aid specialists based on importance for patients and decision-makers and included mortality due to bleeding, all-cause mortality, cessation of bleeding, time to cessation of bleeding, a decrease in bleeding, and complications/adverse effects. Results were reported in Evidence Profiles. Results: Of the 1,051 full-text articles screened, 107 were included for analysis including 22,798 patients. The primary methods of bleeding control were tourniquets (n = 49), hemostatic dressings (n = 34), hemostatic devices (n = 14), pressure dressings/bandages/devices (n = 8), pressure points (n = 4), including 2 studies that reported multiple hemorrhage control methods. Overall, certainty of evidence was very low and often relied on indirect evidence and poorly controlled studies. Tourniquets were associated with a decrease in mortality when compared with direct manual pressure. Hemostatic dressings resulted in a shorter time to hemostasis than direct manual pressure using standard dressings. Direct manual compression resulted in a shorter time to hemostasis than pressure dressings/devices. Conclusion: Overall, data regarding the control of life-threatening bleeding is of very low certainty, making it difficult to draw robust conclusions for treatment by immediate responders. While more robust data is needed on first aid treatments of life-threatening bleeding, this systematic review aggregates the most comprehensive to date to help guide recommendations. Key words: bleeding; hemorrhage; tourniquet; hemostatic dressing; direct pressure.