How pragmatic are the randomised trials used in recommendations for control of glycosylated haemoglobin levels in type 2 diabetic patients in general practice: an application of the PRECIS II tool

Abstract

Background: Recommendations for good clinical practice have been reported to be difficult to apply in real life by primary care clinicians. This could be because the clinical trials at the origin of the guidelines are based on explanatory trials, conducted under ideal conditions not reflecting the reality of primary care, rather than pragmatic trials conducted under real-life conditions. The objective of this study was to evaluate how pragmatic are the clinical trials used to build the French High Authority of Health's recommendations on the management of type II diabetes. Methods: Trials from the 2013 Cochrane meta-analysis that led to the 2013 French High Authority of Health's recommendations on the management of type II diabetes were selected. Each trial was analysed by applying the PRECIS-2 tool to evaluate whether the trial was pragmatic or explanatory, according to the nine domains of PRECIS-2. Each domain was scored between 1 (very explanatory) and 5 (very pragmatic) by two blinded researchers, and consensus was reached with a third researcher in case of discrepancy. Median scores were calculated for each of the nine domains. Results: Twenty-three articles were analysed. Eight out of nine domainsnamely eligibility, recruitment, setting, organisation, flexibility of delivery, flexibility of adherence, follow-up, and primary outcomehad a median score of less than 3, indicating a more explanatory design. Only the primary analysis domain had a score indicating a more pragmatic approach (median score of 4). In more than 25% of the articles, data to score the domains of recruitment, flexibility of delivery, flexibility of adherence, and primary analysis were missing. Conclusions: Trials used to build French recommendations for good clinical practice for the management of type 2 diabetes in primary care were more explanatory than pragmatic. Policy-makers should encourage the funding of pragmatic trials to evaluate the different strategies proposed for managing the patient's treatment according to HbA1C levels and give clinicians feasible recommendations.

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

“…This may be partially explained by the fact that protocols generally reported an intention-to-treat analysis plan. 29,30 However, this finding should be interpreted cautiously since almost one-fifth of the eligible papers failed to report information on the analysis plan.…”

Analysis of the characteristics and the degree of pragmatism exhibited by pragmatic-labelled trials of antineoplastic treatments

“…Despite reviewing all of the available source documents for the included studies, we were unable to appraise most of the PCTs in our sample across every domain of the PRECIS-2 instrument. Other authors [ 63 , 65 , 68 , 70 , 72 , 76 , 79 – 81 ] have likewise struggled to conduct exhaustive PRECIS-2 evaluations within the context of a systematic or scoping literature review. The fields corresponding with the ‘flexibility (adherence)’ and ‘recruitment’ domains on the tool’s accompanying appraisal sheet seem to be especially difficult to complete, even when considering that the former domain is not universally applicable.…”

The Efficacy of a Diet Low in Fermentable Oligo-, Di-, Monosaccharides, and Polyols in Irritable Bowel Syndrome Compared to Its “Real-world” Effectiveness: Protocol for a Systematic Review

“…Based on the pretest, we are confident that the rating system will sufficiently distinguish between efficacy and real-world studies. Furthermore, the PRECIS-2 (by using all domains) has already been successfully used retrospectively by other researchers [48][49][50]. However, it should be acknowledged that the retrospective use of PRECIS-2 has not been well established.…”