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Abstract: Background: Frailty is three to seven times more common in people with chronic kidney disease (CKD) than in those with normal kidney function. Although frailty and its impact in CKD is well-recognized, the measurement properties of the tools used to assess this syndrome are not known. The aim of this systematic review was to evaluate frailty assessment tools and their measurement properties in CKD. Methods: The study was conducted using the Consensus-based Standards for the selection of health Measurement Instruments (COSMIN) guidelines and Preferred Reporting Items for Systematic reviews and Meta-Analyses for Protocols (PRISMA-P 2015). We searched ten electronic databases and screened studies as per the inclusion criteria: peer-reviewed original research, adults with CKD (non-dialysis, dialysis or kidney transplant (KT)), examines at least one established multidimensional tool used for the assessment of frailty, and presents information to evaluate the measurements properties of the tool. Methodological quality assessment and data synthesis were performed as per COSMIN guidelines. This review was registered with PROSPERO (CRD42021234558). Results: We retrieved 648 unique citations with 52 eligible studies of which a majority (n = 37, 71.1%) were prospective cohort studies. A large proportion (n = 12, 23%) of the data was retrieved from prevalent dialysis patients. There was limited data (n = 4, 7.7%) available for KT recipients due to population overlap. Across all studies, the Fried Frailty Tool (original: n = 27, 51.9%; modified: n = 8, 15.4% of studies) was used most frequently. Only three measurement properties were evaluated for the frailty measurement tools: construct validity (discriminative (n = 42, 80.8%); convergent (n = 9, 17.3%), criterion validity (n = 2, 3.8%), and responsiveness (n =2, 3.8%). Studies using the Fried Frailty Tool most commonly evaluated the tool’s discriminative validity. Only in the CKD non-dialysis population, the Fried Frailty Tool demonstrated good discriminative ability (pooled adjusted hazard ratio (aHR): 2.00 (95% CI: 1.51, 2.64, p < 0.001) in estimating the risk of death. Upon assessing the methodological quality of all 52 studies, 51 (98%) had inadequate methodological quality. Only one study comparing the Fried Frailty Tool to the Geriatric Assessment (GA) (criterion validity) was assessed as doubtful methodological quality. Due to the inadequate methodological quality, when rating the studies against the “Updated Criteria for Good Measurement Properties”, all studies presented “indeterminate” overall quality. The quality of evidence per single study or pooled result was graded and resulted in “very low” quality of evidence. Finally, due to the lack of data, we cannot comment on the interpretability and feasibility of the frailty assessment tools used in each study. Conclusions: We aimed to identify the frailty tools validated in CKD and provide a recommendation for a tool(s) for use in clinical research and practice. Although a number of frailty tools exist, only a number have been validated in CKD populations, such as the Fried Frailty Tool, Clinical Frailty Scale (CFS), Frailty Index (FI), Comprehensive Geriatric Assessment (CGA)/GA, FRAIL Scale, and Groningen Frailty Indicator (GFI). The Fried Frailty Tool was used most frequently across all CKD subpopulations and provided sufficient data for construct (discriminative and convergent) validity and criterion validity. However, due to low study quality, we cannot recommend the Fried Frailty Tool with confidence. Additionally, this review also did not identify any studies evaluating the frailty tools' reliability, measurement error, structural validity, internal consistency, and content validity. Hence, we cannot provide a recommendation for a tool(s) as per the COSMIN guidelines for use in clinical research and practice.

Abstract: ABSTRACT Background: Health care requires constant improvement. Harms in health care are becoming a priority, as is incorporating the patient’s voice in both clinical research and clinical care. Patients have been found to provide a more subjective, detailed perspective of their treatment experiences compared with health care providers; this is especially true of potential harms they have experienced. Measurement instruments must be valid and reliable; a new field of Patient Reported Outcome Measures (PROM) has emerged to capture the patient’s perspective and experience. Methods: A systematic review was conducted to identify all patient-reported outcome measures for adverse events (PROM-AE) currently published in the health literature databases. These measures were compared to establish similarities and differences, and to determine if any core characteristics existed. Results: The most commonly used PROM AE in clinical research and clinical practice were evaluated further with regards to their measurement properties. Conclusion: Important gaps, such as minimal harms reporting in clinical research and practice, were identified that could help advance the field of PROM AE and thereby enhance patient safety in both research and clinical settings.

Background: The EQ-5D is a health-related quality of life instrument which provides a simple descriptive health profile and a single index value for health status. The latest version, the EQ-5D-5L, has been translated into more than one hundred languages worldwide - including Thai. This study aims to assess the measurement properties of the Thai version of the EQ-5D-5L (the 5L) compared to the EQ-5D-3L (the 3L). Methods: A total of 117 diabetes patients treated with insulin completed a questionnaire including the 3L and the 5L. The 3L and 5L were compared in terms of distribution, ceiling, convergent validity, discriminative power, test-retest reliability, feasibility, and patient preference. Convergent validity was tested by assessing the relationship between each dimension of the EQ-5D and SF-36v2 using Spearman’s rank-order correlation. Discriminative power was determined by the Shannon index (H ′) and Shannon’s Evenness index (J ′). The test-retest reliability was assessed by examining the intraclass correlation coefficient (ICC) and Cohen’s weighted kappa coefficient. Results: No inconsistent response was found. The 5L trended towards a slightly lower ceiling compared with the 3L (33% versus 29%). Regarding redistribution, 69% to 100% of the patients answering level 2 with the 3L version redistributed their responses to level 2 with the 5L version while about 9% to 22% redistributed their responses to level 3 with the 5L version. The Shannon index (H ′) improved with the 5L while the Shannon's Evenness index (J ′) reduced slightly. Convergent validity and test-retest reliability was confirmed for both 3L and 5L. Conclusions: Evidence supported the convergent validity and test-retest reliability of both the 3L and 5L in diabetes patients. However, the 5L is more promising compared to the 3L in terms of a lower ceiling, more discriminatory power, and higher preference by the respondents. Thus, the 5L should be recommended as a preferred health-related quality of life measure in Thailand.

Abstract: Randomized controlled trials (RCTs) are the gold standard for high quality evidence generation pertaining to treatment effectiveness. RCT results are used in knowledge synthesis and evidence-based practice. The validity of RCT results is dependent upon the validity of the primary outcome measures. Primary outcomes and the measurement properties of the primary outcome measures should be clearly reported to enable confident interpretation of results. A systematic review of pediatric RCTs published in high impact journals found inadequate reporting of primary outcomes and the measurement properties of their outcome measures. Furthermore, quality assessments of the measurement properties and the methodology of the studies in which the properties are evaluated suggest a need for further validation. The issue is thus twofold: inadequate reporting paired with insufficient validation. The awareness of this dual issue can encourage higher reporting standards and improved conduct of trials to ultimately enhance the quality of primary research.