Practical and Relevant Guidelines for the Management of Psoriasis: An Inference-Based Methodology

Abstract

Introduction Psoriasis (Pso) is a common, immune-mediated, chronic-relapsing, inflammatory skin disease. While a great deal is known about Pso and its treatment, there remain several treatment scenarios unaddressed by clinical studies. To be effective, treatment for Pso must alter the activity of one or more immunological pathways important in the pathogenesis of the disease. While the benefit of blocking these pathways may be apparent, there remain uncertainties regarding safety, such as infections, malignancies, and the potential for off-target effects. Existing guidelines and treatment recommendations rely primarily on clinical trial or observational data, none of which adequately address specific clinical challenges. This document describes a methodological framework for generating practical and clinically relevant guidance for situations where direct evidence is rare or absent. Guidelines implementing this framework are currently ongoing. Methods We develop a knowledge synthesis approach to guideline development, utilizing clinical trial data where available, and a formalized inferential decision-making process that considers indirect data coupled with structured expert opinion and analysis. This approach is best suited for situations where direct, high-level evidence is lacking. Support for each resultant recommendation is expressed as a quantified assessment of confidence. Results The topics to be addressed by this set of guidelines are ranked by clinicians and patients as areas of concern, with an emphasis on topics where high-level evidence may have limited availability. Conclusion Through this novel approach, we will derive practical, informative recommendations using the best evidence available in combination with structured expert opinion to guide best practices in complex, real-world settings. Supplementary Information The online version contains supplementary material available at 10.1007/s13555-021-00642-5.

Use of Systemic Therapies for Treatment of Psoriasis in People Living with Controlled HIV: Inference-Based Guidance from a Multidisciplinary Expert Panel

“…The present guidance document is a first demonstration of a formal inference-based process, novel to clinical medicine, to guide practice where high-level evidence is lacking [ 12 ]. In addition to recommendation statements, we provide inference-based conclusions to guide healthcare professional discussions.…”

“…Practically, clinical decisions must be made in the face of limited evidence, and the process of considering indirect evidence is reflective of what physicians do on a case-by-case basis in the clinical setting. We implemented a formalized methodology that takes the onus off the individual physician to review the data and make conclusions on their own [ 12 ]. By breaking the main question down into component parts, addressing the subcomponents, then restructuring the evidence to support a conclusion, we build confidence in the recommendations.…”

“…A panel of 11 dermatologists, three HIV specialists (SLW, JR, AP), and one infectious disease specialist (CLC), convened following the framework of the New Psoriasis Guidelines group [ 12 ]. Through panel discussions directed toward identifying observable scenarios, the primary question was deconstructed in a layered, inference-based approach (Table 1 ).…”

“…Normalization of immune response is sufficient to conclude that the benefits and risks of an intervention are highly similar to those experienced by the general, non-HIV population. Recognizing the paucity of high-level, direct evidence, we implemented a formalized inference-based approach to interrogate indirect evidence of immune response in PLHIV [ 12 ]. Inference-based conclusions were made to address the primary guideline question and generate resultant recommendations.…”

Use of Systemic Therapies for Treatment of Psoriasis in Patients with a History of Treated Solid Tumours: Inference-Based Guidance from a Multidisciplinary Expert Panel

“…A panel of 12 dermatologists and 3 medical oncologists (BM, SS, SH) convened following the framework of the New Psoriasis Guidelines group [ 10 ]. Through panel discussions directed towards identifying observable scenarios with addressable questions, the primary question was deconstructed in multiple revisions using a layered, inference-based approach (Table S1, Supplementary Material).…”