Assessment of consistency between peer-reviewed publications and clinical trial registrations in nursing journals

Abstract

Background: The inconsistencies between randomized clinical trials (RCTs) registrations and peer-reviewed publications may distort trial results and threaten the validity of evidence-based medicine. Previous studies have found many inconsistencies between RCTs registrations and peer-reviewed publications, and outcome reporting bias is prevalent.

Aims: The aims of this review were to assess whether the primary outcomes and other data reported in publications and registered records in RCTs of nursing journals were consistent and whether discrepancies in the reporting of primary outcomes favored statistically significant results. Moreover, we reviewed the proportion of RCTs for prospective registration.

Methods: We systematically searched PubMed for RCTs published in the top 10 nursing journals between March 5, 2020, and March 5, 2022. Registration numbers were extracted from the publications, and registered records were identified from the registration platforms. The publications and registered records were compared to identify consistency. Inconsistencies were subdivided into discrepancies and omissions.

Results: A total of 70 RCTs published in seven journals were included. The inconsistencies involved sample size estimation (71.4%), random sequence generation (75.7%), allocation concealment (97.1%), blinding (82.9%), primary outcomes (60.0%) and secondary outcomes (84.3%). Among the inconsistencies in the primary outcomes, 21.4% were due to discrepancies and 38.6% resulted from omissions. Fifty-three percent (8/15) presented discrepancies in the primary outcomes that favored statistically significant results. Additionally, although only 40.0% of the studies were prospective registrations, the number of prospectively registered trials has trended upward over time.

Linking evidence to action: While not including all RCTs in the nursing field, our sample reflected a general trend: inconsistencies between publications and trial registrations were prevalent in the included nursing journals. Our research helps to provide a way to improve the transparency of research reports. Ensuring that clinical practice has access to transparent and reliable research results are essential to achieve the best possible evidence-based medicine.

Keywords: nursing; outcome reporting bias; publication bias; randomized clinical trials; trial registration.