The quality and reporting of recommendation documents to enhance the integrity of clinical trials: A systematic review and critical appraisal

Abstract

Background

Randomised clinical trials (RCTs) hold the highest validity level in effectiveness research. However, there is a growing concern regarding their trustworthiness. We aimed to appraise the quality and reporting of recommendation documents regarding research integrity to describe their contribution towards fostering RCT integrity.

Methods

Following prospective registration (https://doi.org/10.17605/OSF.IO/DN93K), searches of electronic databases (Scopus, PubMed, Google Scholar) and relevant websites were performed from inception to 30 July 2023 without language limitations. Data extraction and document appraisal using adapted versions of AGREE II, RIGHT and ACCORD checklists were carried out in duplicate. Appraisal data were synthesised as % of the maximum score and documents were classified as: good ≥ 70%, average 50–69%, and poor < 50%.

Results

From 1310 citations 14 recommendation documents were selected. Of these, 11 documents (78%) were of poor quality according to all three appraisal checklists. Reviewer agreement was 86–100% regarding the checklist items. The top three documents were: “International multi-stakeholder consensus statement on clinical trial integrity” (score 70% on AGREE II, 96% on RIGHT and 88% on ACCORD); “Development of consensus on essential virtues for ethics and research integrity” (score 51% on AGREE II, 71% on RIGHT and 77% on ACCORD); and “Hong Kong principles for assessing researchers” (score 19% on AGREE II, 57% on RIGHT and 10% on ACCORD).

Conclusion

There is a room from improvement in the quality and reporting of recommendation documents to help fostering RCT integrity. All stakeholders in the RCT lifecycle making concerted efforts to improve trust in evidence-based medicine need robust guidance to underpin research integrity policies and guidelines.

Resumen

Antecedentes

Los ensayos clínicos aleatorizados (ECA) aportan el máximo nivel de evidencia en investigación; no obstante, existe una preocupación creciente acerca de su fiabilidad. Nuestro objetivo fue evaluar la calidad y el reporte de los documentos que hacen recomendaciones respecto a la integridad de la investigación en los ECA y elucidar su contribución al fomento de la misma.

Métodos

Revisión sistemática por duplicado en Scopus, PubMed, Google Scholar y sitios web relevantes, desde sus inicios hasta julio del 2023, sin restricción de idioma. Para la evaluación de los documentos se utilizaron versiones adaptadas de las listas de verificación AGREE II, RIGHT y ACCORD y se clasificaron en función del porcentaje de puntuación máxima como: buena ≥ 70%, media 50-69% y baja < 50%. Registro prospectivo del protocolo: https://doi.org/10.17605/OSF.IO/DN93K.

Resultados

De 1.310 referencias se seleccionaron 14 documentos, siendo 11 (78%) de baja calidad por las 3 listas de verificación. La concordancia entre los revisores fue del 86-100%. Los documentos con mejores puntuaciones fueron: «International multi-stakeholder consensus statement on clinical trial integrity» (AGREE II: 70%; RIGHT: 96%; ACCORD: 88%); «Development of consensus on essential virtues for ethics and research integrity» (AGREE II: 51%; RIGHT: 71%; ACCORD: 77%) y «Hong Kong principles for assessing researchers» (AGREE II: 19%; RIGHT: 57%; ACCORD 10%).

Conclusiones

Existe un amplio margen de mejora en los documentos que efectúan recomendaciones para fomentar la integridad de los ECA. Todas las partes interesadas en el desarrollo de los ECA deben unir sus esfuerzos para proporcionar políticas y directrices de calidad que fomenten la integridad de la investigación y de esta manera aumentar la confianza en la medicina basada en la evidencia.