Quality and trustworthiness of clinical practice guidelines developed by Italian medical specialty societies: a cross sectional study

The Italian Parliament has recently approved a law to link medical responsibility to clinical practice guidelines (CPGs) developed by medical specialty societies (MSS) and other organizations accredited by the MoH. However, in Italy a national guidelines program has really never taken off, there are hundreds of MSS with inadequate transparency on financial issues and competing interests and there is no evidence about quality and trustworthiness of their CPGs. For this reasons GIMBE funded and conducted this study to verify if Italian CPGs match Guidelines International Network (G-I-N) standards for developing CGPs (G-I-N 1) and for disclosure and management of conflicts of interest (COIs) (G-I-N 2). The study was endorsed by G-I-N and Italian National Institute of Health (NIH). The study was developed in 5 step: 1) Identification of developers: in this first phase the study assessed CPGs developed by MSS. 2) Identification of CPGs through web sites of MSS. 3) Sample selection: CPGs published in 2015-2016. 4) Evaluation of adherence to G-I-N 1. 5) Evaluation of adherence to G-I-N 2. 80% of the identified MSS (322/403) were not eligible for lack of website (n. 6), lack of CPGs webpage (n. 289), CPGs webpage with restricted access (n. 14), and links to other CPGs developers (n. 13). 712 documents were retrieved: 359 (50,4%) were classified as CPGs; the remaining were not accessible files (n. 9), other types of documents (n. 71) and CPGs developed by other organizations (n. 273). 75/359 CPGs (21%) were included for final evaluation. According to G-I-N 1 standards the overall quality is adequate, except for disclosure of COIs available only for 17% of CPGs: for this reason the adherence to G-I-N 2 was not assessed. 42/75 evaluated CPGs were developed by 2 MSS only. In Italy the law on medical responsibility relies a key role on CPGs, but our study shows that few CPGs developed by MSS are trustworthy. Therefore a governance revolution in CPGs development is recommended, with a pivotal role of the Italian NIH that should set priorities, avoid duplication, promote multi-professional and multi-disciplinary CGPs, standardize quality criteria and define strategies for managing COIs.