Reporting of patient-reported outcomes (PROs) in randomized controlled trials of anemia treatments for people with CKD: a scoping review

TL;DR

This study finds that few clinical trials on anemia treatments for kidney disease report patient-reported outcomes, and when they do, reporting is inconsistent.

Contribution

The study is the first to systematically evaluate adherence to PRO reporting guidelines in RCTs of anemia treatments for CKD.

Findings

Only 15% of RCT publications on anemia treatments for CKD reported PRO data.

Most publications failed to follow CONSORT-PRO guidelines for PRO reporting.

PRO measures and reporting methods varied widely across studies.

Abstract

Patient-reported outcomes (PROs) are key outcomes of importance for people with chronic kidney disease (CKD), and may be of even higher relevance for patients with concomitant anemia which can often be symptomatic. Thus, PROs should be included as outcomes in clinical trials of interventions delivered to people with CKD. We evaluated the reporting of PROs in randomized controlled trials (RCTs) of anemia treatments delivered to people with CKD, assessing adherence to Consolidated Standards of Reporting Trials (CONSORT)-PRO reporting guidelines.

We conducted a scoping review in October 2024 using PubMed, Embase, and the Cochrane Central Register of Controlled Trials to identify RCTs of anemia treatments delivered to people with CKD, and subsequently identified publications of these RCTs which reported PROs data. We appraised adherence to seven elements outlined in CONSORT-PRO guidelines.

From 280 publications of 248 eligible RCTs, 41 publications (15%) reported PROs data for iron treatments (n = 16), erythropoiesis stimulating agents (ESAs; n = 22), hypoxia-inducible factor–prolyl hydroxylase inhibitors (HIF-PHIs; n = 2), or HIF-PHIs versus ESAs (n = 1). Data were reported for 22 different PRO measures. Most publications did not adhere to CONSORT-PRO guidelines, with 39% identifying the PRO measure in the study abstract, 7% providing a hypothesis surrounding the PROs, 10% reporting methods of PRO data collection, 27% providing statistical methods for handling missing data, and 10% discussing PRO-specific limitations and implications for generalizability. No publication followed all seven CONSORT-PRO elements evaluated.

There are a limited number of publications reporting PROs from RCTs of anemia treatments delivered to people with CKD. PRO measures used, as well as methods of data reporting and analysis, are highly variable. These findings highlight the need to adhere to established guidelines for reporting PROs data, which will enable interpretability and reliability of data in caring for people with CKD and anemia.

The online version contains supplementary material available at 10.1186/s41687-026-01007-2.

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