Patient-reported outcome measures (PROM) measure attribute studies refer to studies conducted by investigators to validate the measurement attributes of PROM. The consensus-based standards for the selection of health measurement instruments (COSMIN), an international consensus standard for the selection of health measurement instruments, divides this attribute into three aspects: reliability, validity and responsiveness, and adds interpretability as an additional important feature for evaluating PROM. The purpose of this paper is to introduce the verification methods and principles of the three major measurement attributes in the COSMIN consensus, as well as the significance and direction of interpretability evaluation, and to provide international methodological experience and reference for the development of high-quality PROM psychometric attribute verification in China.
Measurement properties studies of patient-reported outcome measures (PROMs) aims to validate the measurement properties of PROMs. In the process of designing and statistical analysis of these measurement properties studies, bias will occur if there are any defects, which will affect the quality of PROMs. Therefore, the COSMIN (consensus-based standards for the selection of health measurement instruments) team has developed the COSMIN risk of bias (COSMIN-RoB) checklist to evaluate risk of bias of studies on measurement properties of PROMs. The checklist can be used to develop systematic reviews of PROMs measurement properties, and for PROMs developers, it can also be used to guide the research design in the measurement tool development process for reducing bias. At present, similar assessment tools are lacking in China. Therefore, this article aims to introduce the primary contents of COSMIN-RoB checklist and to interpret how to evaluate risk of bias of the internal structure studies of PROMs with examples.
The COSMIN-RoB checklist includes three sections with a total of 10 boxes, which is used to evaluate risk of bias of studies on content validity, internal structure, and other measurement properties. COSMIN classifies reliability, measurement error, criteria validity, hypothesis testing for construct validity, and responsiveness as other measurement properties, which primarily focus on the quality of the (sub)scale as a whole, rather than on the item level. Among the five measurement properties, reliability, measurement error and criteria validity are the most widely used in the studies. Therefore, this paper aims to interpret COSMIN-RoB checklist with examples to guide researchers to evaluate the risk of bias of the studies on reliability, measurement error and criteria validity of PROMs.
The COSMIN community updated the COSMIN-RoB checklist on reliability and measurement error in 2021. The updated checklist can be applied to the assessment of all types of outcome measurement studies, including clinician-reported outcome measures (ClinPOMs), performance-basd outcome measurement instruments (PerFOMs), and laboratory values. In order to help readers better understand and apply the updated COSMIN-RoB checklist and provide methodological references for conducting systematic reviews of ClinPOMs, PerFOMs and laboratory values, this paper aimed to interpret the updated COSMIN-RoB checklist on reliability and measurement error studies.
Systematic review 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 review 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 review 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 reviews.
ObjectiveThis study aimed to systematically review the quality of psychometric properties and methodological quality of the Chinese versions of fear of falling assessment tools for the elderly, providing evidence-based guidance for medical staff in selecting high-quality assessment tools. MethodsWe systematically searched CNKI, WanFang Data, VIP, CBM, PubMed, Embase, and Web of Science databases for studies related to the evaluation of psychometric properties and methodological quality of fear of falling assessment tools for the elderly. The search spanned from the inception of the databases to January 19, 2024. Two researchers independently screened literature and extracted data using the consensus-based standards for the selection of health measurement instruments. The COSMIN risk of bias checklist and quality criteria were employed to evaluate instrument measurement characteristics and formulate final recommendations. ResultsFifteen studies involving 11 Chinese versions of fear of falling assessment tools for the elderly were included. None of the studies reported measurement error, cross-cultural validity, or responsiveness. Due to insufficient or uncertain content validity and low or below-quality evidence, all 11 tools received a recommendation of level B. ConclusionAmong the 11 instruments, the Chinese version of IFES demonstrates the most balanced measurement characteristics, along with good reliability and validity. However, further verification of other measurement characteristics of this instrument is warranted.
ObjectiveTo construct a framework and functional items of a scientific research assistant tool for conducting systematic review for patient-reported outcome measures. MethodsBased on the research foundation and work experience of the system evaluation of two patient-reported outcome measures systematic reviews carried out by the research group in the early stage, the framework and function system of scientific research aid tool was initially constructed, and two rounds of correspondence were carried out by Dephi expert consultation method. ResultsThe effective recovery rates of the two rounds of expert consultation questionnaires were 90% and 100%, the expert authority coefficient was 0.839, and the compatibility coefficients of suitability and importance were 0.105 and 0.177, respectively. The final the patient-reported outcome measures tool system evaluation scientific research aid tool system consists of 7 frames and 31 items. ConclusionThis study has developed a scientific and comprehensive set of functional criteria for research-assistant tools that systematically review patient-reported outcome measures based on the COSMIN methodology and it lays the foundation for subsequent tool research and development.
ObjectiveTo systematically review the measurement properties of observational pain assessment scales for pediatric patients after surgery. MethodsThe PubMed, Embase, CINAHL, PsycArticles, and SinoMed databases were electronically searched to collect studies related to the objectives from inception to April 13, 2024. Two reviewers independently screened literature, extracted data and assessed the risk of bias of the included studies. And the quality of measurement properties was rated using updated criteria for good measurement properties to determine recommendation levels. ResultsA total of 26 studies were finally included involving 12 observational pain assessment scales for pediatric patients after surgery. None reported measurement error or cross-cultural validity. The overall content validity of all 12 scales was evaluated by reviewers, with measurement properties rated as sufficient or inconsistent. For internal consistency, due to insufficient or uncertain content validity, the evidence quality was low. Eight scales calculated internal consistency, among which CHEOPS, CHIPPS, COMFORT, FLACC, and NCCPC-PV scales had sufficient measurement properties with evidence quality of low or above, receiving Grade A recommendations. ConclusionCompared with other scales, CHEOPS, CHIPPS, COMFORT, FLACC, and NCCPC-PV scales demonstrated good measurement property evaluation with acceptable evidence quality and can be recommended for use. Other scales still require further improvement in measurement property validation.
The selection of outcome measurement instruments (OMI) is a prerequisite for accurately collecting health outcome data. Conducting a systematic review of OMI can provide an important reference for researchers and practitioners to select the most appropriate OMI. In order to improve the reporting quality of the systematic review of OMI, foreign researchers published the PRISMA-COSMIN reporting guideline in the J Clin Epidemiol in June 2024. This article introduces the research team, development process, and items of the reporting guideline, and analyzes the items with examples. We hope our attempt could help domestic researchers improve the overall quality of OMI systematic reviews.
ObjectiveTo systematically review the methodological quality and measurement properties of dyspnea assessment tools for chronic obstructive pulmonary disease (COPD) patients based on the consensus-based standards for the selection of health measurement instruments (COSMIN) guidelines, and provide evidence for clinicians in selecting the optimal assessment tool. MethodsComputerized searches were conducted in PubMed, Web of Science, Embase, CNKI, VIP, and Wanfang databases for studies related to dyspnea assessment tools in COPD patients, from the establishment of each database until April 2024. Two researchers independently screened and extracted data according to the inclusion and exclusion criteria. The included assessment tools were evaluated based on the COSMIN guidelines, and final recommendations for the tools were formulated. ResultsA total of 18 studies were included, involving 14 dyspnea assessment tools for COPD patients. The following tools were recommended as Grade A: SOBDA, PFSDQ-M, Chinese version of Dyspnoea-12, Norwegian version of Dyspnoea-12, and RSQ. Grade B recommendations included the Chinese version of the revised PFSDQ, SOBQ-UCSD version, S-CRQ, CRQ-SR, C-MRADLQ, and BCSS. Grade C recommendations included the Arabic version of Dyspnoea-12, Chinese version of COPD-MSD, and C-SOBQ. ConclusionsThe scales SOBDA, PFSDQ-M, Chinese version of Dyspnoea-12, Norwegian version of Dyspnoea-12, and RSQ have been comprehensively evaluated across various measurement properties and demonstrate good reliability and validity. Considering the national context in China, the Chinese version of Dyspnoea-12 is tentatively recommended, though other measurement properties still require further validation.