Analysis of the quality of reporting and risk of bias of Clinical Trials published in Latin American Nursing Journals

Article type
Authors
Buitrago-garcia D1, Medina-Aedo M2, Montesinos-Guevara C3, Alberto Castro C4, Pardo-Hernández H5, Bonfill X5
1Hospital Universitario Mayor - Méderi. Universidad del Rosario. Bogotá, Colombia. , Bogotá, Colombia; Geneva University Hospitals and University of Geneva , Geneva, Switzerland
2Department of Paediatrics, Obstetrics & Gynaecology and Preventive Medicine and Public Health,.Universitat Autònoma de Barcelona. , Barcelona, Spain; Iberoamerican Cochrane Centre, Biomedical Research Institute Sant Pau (IIB SantPau), Barcelona, Spain
3Cochrane Ecuador, Centro de Investigación en Salud Pública y Epidemiología Clínica (CISPEC), Facultad de Ciencias de la Salud Eugenio Espejo, Universidad UTE, Quito, Ecuador
4Fundación Universitaria de Ciencias de la Salud-FUCS , Bogotá, Colombia
5Iberoamerican Cochrane Centre, Biomedical Research Institute Sant Pau (IIB SantPau), Barcelona, Spain; CIBER de Epidemiología y Salud Pública (CIBERESP), Universitat Autònoma Barcelona, Barcelona, Spain
Abstract
"Introduction: Randomised controlled trials (RCTs) are the basis of systematic reviews. They are also helpful as input for other evidence synthesis, such as clinical guidelines. The scientific production published in nursing journals from Latin America is steadily increasing, but little is known about the number of RCTs published, their quality and scientific rigour.

Objective: To identify and assess the quality of reporting and risk of bias in RCTs published in nursing journals in Latin America.

Methods: We hand-searched RCTs published in nursing journals from Latin America and the Caribbean up to 2023. Handsearching was conducted following Cochrane guidance, which states that each journal article must be carefully reviewed, including original articles and other types of studies, letters to the editor, abstracts, and conference presentations. We assessed the quality of reporting using the CONSORT statement. We determined the risk of bias using Cochrane’s risk of bias tool, including the randomisation sequence generation, allocation concealment, blinding of patients and those assessing outcomes, missing data, and patient follow-up domains.

Results: We reviewed 30 nursing journals and identified 29 RCTs published in 10 of them; 17(60%) were published in the “Research and Education in Nursing” journal. Most studies (20, 68%) were conducted in a hospital setting and aimed to assess the effectiveness of educational interventions. The items with suboptimal reporting were mainly found in the methods section. The risk of bias was predominantly high in domains related to allocation concealment and blinding of participants.

Conclusions: We found suboptimal reporting of RCTs. Overall, they had a high risk of bias. Authors and researchers in the nursing field should adhere to the CONSORT statement when designing and reporting RCTs and implement recommendations from Cochrane and other institutions to enhance the quality of future clinical trials. By reporting and conducting better RCTs, it will be possible to have the best evidence available to improve the healthcare delivery for patients and consumers. "