| Abstract | Aim: The aim of this study is to determine the reporting of data on gender and ethnicity in RCTs of interventions for heart failure treatment in the major journals from the field of cardiology from 2017 to 2019.
Methods: We analysed 344 RCTs published between January 2017 to December 2019 in top five cardiology journals. Full-length papers on heart failure were analysed for reporting on sex/gender and race/ethnicity considerations. We extracted the data for: journal name, year of publication, study name, sex or race detailed terminology explained, sex or race mentioning in the title, abstract or introduction, number of study participants, number of male and female subjects, list of different ethnic backgrounds, sex and race specific analyses planned in the methods and results, differences in the sex and race specific results, sex and race specific results mentioned in the discussion section and centre of the study.
Results: Majority of the RCTs were published in the year 2018 (151; 43.9%), followed by 2017 (115; 33.4%) and 2019 (78; 22.7%). The highest number of RCTs were published in the Journal of the American College of Cardiology (121; 35.2%) and Circulation (118; 34.3%), whereas lowest numbers were published in the European Heart Journal (10; 2.9%). Overall, 63 (18.3%) of published RCTs reported sex/gender in the abstract section, and race/ethnicity was mentioned only in 16 (4.65%). Sex/gender differences from previous studies were mentioned in the Introduction section in 3.5% of the studies, while race differences in only 2.91%. Most of the papers in this study (N=305; 88.6%) mentioned sex/gender in any of the sections, while race/ethnicity was mentioned in a total of 212 papers (61.6%). In the methods section, 35 (10.2%) papers described plans to examine results separately by sex/gender, and only 17 (4.9%) overall planned to examine differences in race/ethnicity in their research. In a total of 180 (52.3%) papers, at least one analysis in results section was included based on gender, while race specific results were reported in 67 (19.4%) papers. White population was included in highest number of papers (N=71), and studies with white population included significantly larger number of participants (1086 (103.5-3633)) in comparison with others (P<0.001).
Conclusion: With sex/gender and race/ethnicity specific analyses neglected in majority of the included studies, researchers should invest more efforts to plan, conduct and report sex/gender and race/ethnicity outcomes in future RCTs. |
| Abstract (croatian) | Cilj: Cilj ovog istraživanja bio je procijeniti izvještavanje o spolu i etničkoj pripadnosti u randomiziranim kontroliranim ispitivanjima (RCT) intervencija za liječenje srčanog zatajenja u časopisima iz područja kardiologije u razdoblju od 2017. do 2019. godine.
Metode: Analizirali smo 344 RCT-a objavljena u razdoblju od siječnja 2017. do prosinca 2020. u top pet časopisa iz kardiologije. Cjelokupni članci (radovi) o zatajenju srca analizirani su radi izvještavanja o spolu i etničkoj pripadnosti. Izdvojili smo podatke za: naziv časopisa, godinu publiciranja, naziv istraživanja, detaljno tumačenje termina spola ili rase, spominjanje spola i rase u naslovu, sažetku ili uvodu, broj sudionika u istraživanju, broj muškaraca i žena, popis različitih etničkih skupina, specifične analize planirane u metodama i rezultatima vezane za spol i rasu, razlike u rezultatima ovisno o spolu i rasi, rezultatima povezanima sa spolom i rasi u odjeljku rasprave i mjestu istraživanja.
Rezultati: Većina RCT-ova objavljena je u 2018. godini (151; 43,9%), a slijede 2017. (115; 33,4%) i 2019. (78; 22,7%). Najveći broj RCT-a objavljen je u časopisu Journal of the American College of Cardiology (121; 35,2%) i Circulation (118; 34,3%), dok je najmanji broj objavljen u European Heart Journal (10; 2,9%). Sveukupno, 63 (18,3%) objavljenih RCT-a prijavilo je spol u uvodu, a rasa / etnička pripadnost su spomenuti tek u 16 (4,65%). Razlike u spolu u odnosu na prethodne studije spomenute su u odjeljku uvoda u 3,5% studija, dok su razlike u rasama spomenute u samo 2,91% uvoda. Većina radova u ovom istraživanju (N = 305; 88,6%) spominjala je spol u barem nekom od odjeljka, dok je rasa/etnička pripadnost spomenuta u ukupno 212 radova (61,6%). U odjeljku o metodama, 35 (10,2%) radova opisalo je planove za ispitivanje rezultata odvojeno prema spolu, a samo 17 (4,9%) ukupno je planiralo ispitati razlike u rasi / etničkoj pripadnosti u svojim istraživanjima. U ukupno 180 (52,3%) radova, najmanje jedna analiza u odjeljku rezultata bila je vezana uz spol, dok su rezultati specifični za rasu prijavljeni u 67 (19,4%) radova. Bijela populacija bila je uključena u najveći broj radova (N = 71). Nadalje, studije s bijelom populacijom uključivale su značajno veći broj sudionika (1086 (103,5-3633)) u usporedbi s ostalim (P <0,001).
Zaključak: S obzirom na to da su analize spola i etničke pripadnosti zanemarene u većini uključenih studija, istraživači bi trebali uložiti više napora u planiranje, provođenje i izvještavanje o ishodima vezanima uz spol i etničku pripadnost u budućim RCT-ovima. |
