Generalizability of randomized controlled trials in primary health care: Applying the PRECIS‐2 tool on published protocols

• Published in: Journal of evaluation in clinical practice 2023-03, Vol.29 (2), p.253-262
• Main Authors: Papagiannopoulou, Evridiki, Laiou, Elpiniki, Tatsi, Chrysanthi, Dimakopoulos, Georgios, Ntzani, Evangelia E., Siamopoulos, Konstantinos, Tatsioni, Athina
• Format: Article
• Language: English
• Subjects: Clinical trials; explanatory; generalizability; Humans; pragmatic; Pragmatism; Primary care; Primary Health Care; randomized controlled trial; Randomized Controlled Trials as Topic; Research Design; Sample Size
• ISSN: 1356-1294; 1365-2753
• DOI: 10.1111/jep.13759

Rationale Pragmatic design may facilitate the generalizability of effectiveness of randomized controlled trials (RCTs) in primary health care (PHC). Aims and Objectives The aim of this study was to investigate whether published protocols in PHC were designed pragmatically and to explore whether specific trial characteristics may be related to a pragmatic design. Methods Using the Pragmatic Explanatory Continuum Indicator Summary‐2 (PRECIS‐2), we assessed pragmatism for 123 published RCT protocols. For each domain, we calculated the mean score with the 95% confidence interval (95% CI). Interrater reliability was assessed by weighted κ‐coefficient with 95% CI. We examined potential associations of published protocol characteristics with overall pragmatism by performing univariate and multivariate analyses. Results We observed the highest score for primary analysis (4.66, 95% CI: 4.51, 4.82). The eligibility score was intermediate (3.16, 95% CI: 3.01, 3.32). Domains with scores towards the explanatory side included organization (2.50, 95% CI: 2.36, 2.63), flexibility of delivery (2.74, 95% CI: 2.60, 2.88) and flexibility of adherence (3.00, 95% CI: 2.83, 3.17). Interrater agreement was good (κ = 0.61; 95% CI: 0.34, 0.80; p