{"doi":"10.2215/cjn.14900920","title":"Moving the Science of Patient-Reported Outcome Measures Forward","abstract":"Although almost everyone knows the feeling of fatigue, few people experience it as often as patients with ESKD on maintenance hemodialysis (HD). A majority of HD patients report feeling fatigued on a regular basis (1), affecting their ability to accomplish the tasks they want and need to do, including work, caring for family, and pursuing personal aspirations (2). Although fatigue is associated with mortality in maintenance HD patients, many patients and caregivers say that relieving fatigue matters more to them than avoiding death (3). The article by Ju et al. (4) in this issue of CJASN is grounded in recognition of the importance of fatigue relative to many other outcomes studied in nephrology. Ju et al.’s work stems from a larger effort known as the Standardized Outcomes in Nephrology (SONG) initiative, which aims to establish core outcomes and measures that reflect the priorities of key stakeholders in nephrology, including patients and caregivers. In this article, the authors report the findings of the first psychometric evaluation of a patient-reported outcome measure (PROM) for fatigue in HD patients. Put simply, a patient-reported outcome (PRO) is information about a patient’s health, quality of life, or functional status that is obtained directly from the patient; a PROM is an instrument for reporting a PRO (5). Chart review alone could reveal the “hard” outcomes that have dominated clinical trials in nephrology, such as survival, cardiovascular events, and hospitalizations, as well as surrogate outcomes, such as laboratory values. However, as the SONG-HD initiative has demonstrated, outcomes such as these are not the only ones that matter to patients (3). A Kidney Disease Improving Global Outcomes controversies conference acknowledged this fact when it recently recommended that future trials include PROMs as end points (6). In 2009, the US Food and Drug Administration issued guidance to the pharmaceutical and medical device industries describing how it will review and evaluate PROMs used to support claims in product labeling (7). This guidance, along with the Consensus-Based Standards for the Selection of Health Status Measurement Instruments (8), specifies that the key measurement properties of a PROM are reliability, validity, and responsiveness (Table 1). Table 1. - Key measurement properties of patient-reported outcome measures Measurement Property Property Subtype Description Evaluation Reliability ∙ Test-retest/intrainterviewer reliability (for interviewer-administered PROMs only) ∙ Stability of scores over time when no change is expected in the concept of interest ∙ Intraclass correlation coefficient ∙ Time period of assessment ∙ Internal consistency ∙ Extent to which items comprising a scale measure the same concept ∙ Cronbach’s α for summary scores ∙ Intercorrelation of items that contribute to a score ∙ Item-total correlations ∙ Interinterviewer reliability (for interviewer-administered PROMs only) ∙ Agreement among responses when the PROM is administered by ≥2 different interviewers ∙ Interclass correlation coefficient Validity ∙ Content validity ∙ Evidence that the instrument measures the concept of interest. Includes evidence from qualitative studies that the items and domains of an instrument are appropriate and comprehensive for its intended measurement concept, population, and use ∙ Derivation of all items ∙ Qualitative interview schedule ∙ Interview or focus group transcripts ∙ Items derived from the transcripts ∙ Composition of patients used to develop content ∙ Cognitive interview transcripts to evaluate patient understanding ∙ Construct validity ∙ Evidence that relationships among items, domains, and concepts conform to a priori hypotheses of logical relationships that should exist with measures of related concepts or scores produced in similar or diverse patient groups ∙ Strength of correlation testing a priori hypotheses (discriminant and convergent validity) ∙ Degree to which the PROM can disti","journal":"Clinical Journal of the American Society of Nephrology","year":2020,"id":88535,"datarank":0.0,"base_score":0.0,"endowment":0.0,"self_citation_contribution":0.0,"citation_network_contribution":0.0,"self_endowment_contribution":0.0,"citer_contribution":0.0,"corpus_percentile":null,"corpus_rank":null,"citation_count":10,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9584,"is_data_producer":false,"deposit_databanks":null,"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2020-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":448960,"name":"Jennifer S. Scherer","orcid":"0000-0003-4679-5673","position":1,"is_corresponding":false},{"id":448959,"name":"Sarah Ramer","orcid":"0000-0001-8584-1148","position":0,"is_corresponding":true}],"reference_count":11,"raw_metadata":null,"created_at":"2026-07-18T22:01:22.387926Z","pmid":"33174861","pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}