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.
The reporting completeness of patient-reported outcomes in cancer pain trials is moderate at 65.65%, indicating a need for improved adherence to reporting guidelines.
Where it sits
this study against the rest of the vip (vasoactive intestinal polypeptide) corpusSummary and findings
This study evaluated the reporting completeness of patient-reported outcomes (PROs) in randomized controlled trials (RCTs) of cancer pain. A total of 20 studies involving 3841 patients were analyzed, revealing an overall mean CONSORT-PRO reporting completeness of 65.65%. PROs were used as primary outcomes in 14 studies and as secondary outcomes in 6 studies.
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).
Background
This paper addresses the quality of patient-reported outcome reporting in randomized controlled trials focused on cancer pain, an important aspect of clinical research that informs treatment efficacy and patient experience. Prior studies have indicated variability in PRO reporting, which can affect the interpretation of trial results. This systematic review is significant as it systematically evaluates the adherence to CONSORT-PRO guidelines, aiming to enhance the quality of reporting in future trials.
Methods
The study employed a systematic search of both Chinese and international databases to identify relevant RCTs published from January 1, 2015, to March 1, 2026. Trials included in the review utilized PROs as either primary or secondary outcomes. The CONSORT-PRO extension was applied to evaluate reporting quality, and descriptive subgroup analyses were performed to assess variations across different trial characteristics.
Results
The primary finding indicates that the overall mean CONSORT-PRO reporting completeness was 65.65%. Among the 20 studies analyzed, PROs were reported as primary outcomes in 14 studies and as secondary outcomes in 6 studies. The study identified that certain trial characteristics corresponded to higher reporting completeness, although specific details were not provided in the abstract.
Interpretation
The findings suggest that while there is a moderate level of reporting completeness for PROs in cancer pain trials, there is significant room for improvement. The effect size of 65.65% reporting completeness is statistically significant but may not be clinically meaningful without further context on the impact of these outcomes on patient care. Limitations include the lack of detailed information on how specific trial characteristics influenced reporting completeness, which could affect the generalizability of the results.
Key findings
- 20 studies identified, n=3841 patients.
- PROs used as primary outcomes in 14 studies (70.00%).
- PROs used as secondary outcomes in 6 studies (30.00%).
- Overall mean CONSORT-PRO reporting completeness was 65.65%.
Limitations
- Moderate reporting completeness at 65.65%.
- Lack of detailed analysis on trial characteristics affecting completeness.
- Not reported in abstract.