Quality of patient-reported outcome reporting and related trial characteristics in randomized controlled trials of cancer pain: A systematic review based on the CONSORT-PRO extension.

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Original abstract

<h4>Objective</h4>To systematically evaluate the reporting completeness of patient-reported outcomes (PROs) in randomized controlled trials of cancer pain and to descriptively examine how reporting completeness varied across trial characteristics.<h4>Methods</h4>A systematic search of four Chinese literature databases (CNKI, SinoMed, VIP, Wanfang) and three international databases (PubMed, Cochrane Library, Embase) was conducted to identify relevant trials. Randomized controlled trials (RCTs) on cancer pain published from 1 January 2015 to 1 March 2026 that used PROs as either primary or secondary outcomes were included. The Consolidated Standards of Reporting Trials for PRO (CONSORT-PRO) extension was used to evaluate the quality of PRO reporting in each trial. Descriptive subgroup analyses were conducted to explore the distribution of CONSORT-PRO reporting completeness across trial characteristics.<h4>Results</h4>A total of 20 studies involving 3841 patients were identified. Among these, PROs were used as primary outcomes in 14 studies (70.00%) and as secondary outcomes in 6 studies (30.00%). The main PRO instruments were the Brief Pain Inventory (BPI) and Brief Pain Inventory-Short Form (BPI-SF), the Numeric Rating Scale (NRS) and Numeric Rating Pain Scale (NRPS), and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). The overall mean CONSORT-PRO reporting completeness was 65.65%, indicating a moderate level. Descriptive subgroup analyses identified several trial characteristics that appeared to correspond to higher CONSORT-PRO reporting completeness.<h4>Conclusions</h4>The reporting completeness of PROs in cancer pain RCTs is moderate, with room for improvement in areas such as PRO hypotheses, target domains, and missing data. Future studies should focus on adhering to CONSORT-PRO guidelines, particularly in reporting PRO hypotheses and target domains, and ensure appropriate follow-up durations to improve data quality and clinical applicability.<h4>Systematic review registration</h4>PROSPERO (CRD420261281620).

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