TY - JOUR

T1 - Contribution of Italian clinical research for contrast media-induced nonrenal adverse drug reactions over the last three decades

T2 - A systematic review

AU - Sessa, Maurizio

AU - Rossi, Claudia

AU - Mascolo, Annamaria

AU - Scafuro, Antonella

AU - Ruggiero, Rosanna

AU - Di Mauro, Gabriella

AU - Cappabianca, Salvatore

AU - Grassi, Roberto

AU - Sportiello, Liberata

AU - Rafaniello, Concetta

PY - 2018/7/1

Y1 - 2018/7/1

N2 - The aim of this study was to investigate the scientific contribution of Italian clinical research for contrast media-induced nonrenal adverse drug reactions over the last three decades. Ovid Embase, Ovid MEDLINE, Web of Science, and Cochrane Methodology Register were used as data sources to identify Italian descriptive studies, observational studies, meta-analyses, and clinical trials assessing contrast media-induced nonrenal adverse drug reactions as a safety outcome. The population of interest was men and women exposed to a contrast medium. Between 1990 and 2017, 24 original articles investigating contrast-induced nonrenal adverse drug reactions were identified. The cohort study was the most representative study design (10/24; 41.7%). The 24 studies were conducted mainly as monocenter studies (14/24; 58.3%) and without receiving funding (17/24; 70.8%). Seventeen out of 24 studies provided a level of evidence ranging from III-2 (11/24; 45.8%) to IV (6/24; 25.0%) on a Merlin scale. In total, 14 of 24 (58.3%) studies were published in a scientific journal ranked in the first quartile of their subject area. The 24 original articles mainly focused on adverse drug reactions already observed during clinical trials (i.e., idiosyncratic systemic reactions). In conclusion, during the last three decades and a burst was not observed in the Italian clinical research investigating contrast-induced nonrenal adverse drug reactions. High-quality clinical research is needed especially for procedures to prevent the onset of the aforementioned events, to identify risk factors, to minimize the risk of their occurrence, and to optimize their related prognosis.

AB - The aim of this study was to investigate the scientific contribution of Italian clinical research for contrast media-induced nonrenal adverse drug reactions over the last three decades. Ovid Embase, Ovid MEDLINE, Web of Science, and Cochrane Methodology Register were used as data sources to identify Italian descriptive studies, observational studies, meta-analyses, and clinical trials assessing contrast media-induced nonrenal adverse drug reactions as a safety outcome. The population of interest was men and women exposed to a contrast medium. Between 1990 and 2017, 24 original articles investigating contrast-induced nonrenal adverse drug reactions were identified. The cohort study was the most representative study design (10/24; 41.7%). The 24 studies were conducted mainly as monocenter studies (14/24; 58.3%) and without receiving funding (17/24; 70.8%). Seventeen out of 24 studies provided a level of evidence ranging from III-2 (11/24; 45.8%) to IV (6/24; 25.0%) on a Merlin scale. In total, 14 of 24 (58.3%) studies were published in a scientific journal ranked in the first quartile of their subject area. The 24 original articles mainly focused on adverse drug reactions already observed during clinical trials (i.e., idiosyncratic systemic reactions). In conclusion, during the last three decades and a burst was not observed in the Italian clinical research investigating contrast-induced nonrenal adverse drug reactions. High-quality clinical research is needed especially for procedures to prevent the onset of the aforementioned events, to identify risk factors, to minimize the risk of their occurrence, and to optimize their related prognosis.

KW - Adverse drug reactions

KW - clinical research

KW - contrast media

KW - humans

KW - Italy

UR - http://www.scopus.com/inward/record.url?scp=85058847493&partnerID=8YFLogxK

U2 - 10.4103/jpp.JPP_92_18

DO - 10.4103/jpp.JPP_92_18

M3 - Review

AN - SCOPUS:85058847493

VL - 9

SP - 131

EP - 146

JO - Journal of Pharmacology and Pharmacotherapeutics

JF - Journal of Pharmacology and Pharmacotherapeutics

SN - 0976-500X

IS - 3

ER -