Systematic evaluation of patient-reported outcome measures (PROMs) is crucial for identifying high-quality PROMs for research and clinical practice. It ensures reliable health outcomes data collection. But current PROMs systematic evaluation reports vary in quality and have many defects. To address this, in 2024, the guideline research team updated and published the COSMIN guideline V2.0 for PROMs systematic evaluation and two other tools in the Quality of Life Research. This paper interprets the guideline development team, method, and the core content of the COSMIN guideline V2.0. It also uses specific examples to promote standardized PROMs selection and clinical application, aiming to help domestic researchers improve the quality of such systematic evaluations.
By employing the nominal group technique, as per the process standard of the EQUATOR Collaboration Network, experts were selected through purposeful sampling. Two rounds of nominal group discussions were conducted, and the essential information of the utilization of the consensus method was extracted from the literature. After comparison, discussion, evaluation, and optimization, a list of 3 fields, 11 themes, 63 necessary items, and 28 supplementary items was eventually constructed to upgrade the standardization and rigor of the application of the consensus method in the future, assisting guideline developers to plan the consensus process.
In the clinical evidence-based decision-making process, factors including benefits and harms, evidence certainty, cost and feasibility of interventions should be considered based on the best evidence. The development of decision threshold of effect size (DTES) for patient health outcomes can help stakeholders understand the benefits and harms of interventions, assess evidence certainty, and interpret research results. Based on international experience, the MERGE Working Group through group discussions, semi-structured interviews, expert consensus, and pilot application developed a set of 8-step guidelines for the development of DTES for health outcomes. These steps included necessity assessment, formation of working groups, selection of patient important outcomes, creation of scenarios based on the best evidence, design of expert consultation questionnaires, analysis of expert consultation results, face-to-face expert consensus, dissemination of the application and reevaluation. The DTES guideline development is intended to provide methodological guidance for stakeholders to develop DTES for health outcome indicators in different domains.
