| Abstract | Cilj istraživanja: Procijeniti izvještavanje o spolu u randomiziranim kontroliranim pokusima za liječenje opstrukcijske apneje tijekom spavanja.
Materijali i metode: Ovo je presječno meta-epidemiološko istraživanje. Uključene studije smo dobili pretraživanjem baze MEDLINE. Kriteriji uključenja bili su: intervencijski RCT-ovi za liječenje OSA-e objavljeni u posljednjih 5 godina (od 2015. do 2019. godine), studije na engleskom jeziku, studije koje su uključile samo ispitanike odrasle dobi te studije koje su provedene na ljudima. Pretraživanjem punih tekstova članaka ekstrahirali smo podatke o časopisima u kojima je studija objavljena, tipu provedene terapijske intervencije, broju i spolu ispitanika, izvještavanju o spolu ispitaniku u pojedinim djelovima studije, planiranju spolno-specifične analize u Metodama, postojanju spolno-specifične analize u Rezultatima, postojanju spolno-vezanih razlika u spolno-specifičnim rezultatima te postojanje komentara o spolno-vezanim razlikama u Raspravi. Također, za svaki časopis u kojem su objavljene uključene studije smo pronašli čimbenik odjeka (JIF) prema Journal Citation Reportu (JCR) iz 2019. godine te smo prema njemu časopise razvrstali u kvartile.
Rezultati: Analizirano je 212 RCT-ova. Prosječan broj ispitanika u studijama je 54 (30 – 117). Većina studija, njih 184 (87%) je uključila ispitanike oba spola. Udio žena u ukupnom broju ispitanika u studijama gdje znamo omjer muških i ženskih ispitanika iznosi 27,8% (17,9% – 37,9%), a medijan njihovog omjera iznosi 2,6 (1,64 – 4,57). Spol sudionika istraživanja je spomenut u Naslovu 10 (4,7%) studija te u Sažetku 44 (20,8%) studije. Spolne razlike utvrđene u prijašnjim studijama o opstrukcijskoj apneji tijekom spavanja spomenute su u Uvodu 52 (24,5%) studije. Niti jedna studija nema objašnjen termin spola u Uvodu ili Metodama. U svega 11 (5,2%) studija je planirana spolno-specifična analiza u Metodama, 20 (9,4%) studija navodi najmanje jednu spolno-specifičnu analizu u Rezultatima, a u 11 (5,2%) studija su komentirane spolno-vezane razlike u Raspravi. S obzirom na kvartilu časopisa u kojem su studije objavljene, postoji značajno veća učestalost izvještavanja o spolu ispitanika u Sažetku studija objavljenih u časopisima Q1 i Q2 (P = 0,048) te značajno veća učestalost izvještavanja o spolno-specifičnoj analizi u Rezultatima studija objavljenih u časopisima Q1 (P = 0,016).
Zaključak: Iako su u RCT-ove za liječenje OSA-e većinom uključena oba spola, postotak uključenih žena, kao i postotak studija koje imaju spolno-specifične rezultate je malen. S obzirom da je poznato kako je OSA bolest u kojoj postoji niz značajnih razlika u simptomima, dijagnozi, posljedicama i liječenju između muškaraca i žena, potrebno je od istraživača zahtijevati uključenja žena u studije, planiranje i izvođenje spolno-specifičnih analiza te tumačenje spolno-vezanih rezultata. Takva praksa bi u budućnosti omogućila da OSA-u liječimo personalizirano, tj. spolno prilagođeno. |
| Abstract (english) | Objectives: To estimate reporting of sex in randomized controlled trials of obstructive sleep apnea treatment.
Materials and methods: This is a cross-sectional meta-epidemiological study. By searching MEDLINE database we got the included studies. Inclusion criteria were: intervention RCTs of the treatment of OSA published in the last 5 years (from 2015 to 2019), studies written in English language, studies involving only adult participants and studies conducted on humans. By searching full texts of the articles, we extracted journal data, type of therapeutic intervention, number and sex of participants, reporting on sex of participants in individual parts of the study, planning sex-specific analysis in Methods, existence of sex-specific analysis in Results, existence of sex-related differences in sex-specific results and existence of the comments on sex-related differences in Discussion. Also, for each journal in which the included studies were published, we found the journal impact factor (JIF) according to the Journal Citation Report (JCR) from 2019, and according to JIF, we classified the journals into quartiles.
Results: 212 RCTs were analyzed. The average number of participants per study is 54 (30 – 117). Most of the studies, 184 (87%) of them, included both sex participants. The proportion of women in total participants number, in studies were the ratio of male to female participants is known, is 27.8% (17.9% – 37.9%), while the median of their ratio is 2.6 (1.64 – 4.57). Sex of the participants is mentioned in 10 (4.7%) studies Titles, and in 44 (20.8%) Abstracts. Sex differences determined in previous studies on OSA were mentioned in 52 (24.5%) Introductions. None of the studies has explained the term sex in the Introduction or Methods. Merely 11 (5.2%) of the studies have planned sex-specific analysis in Methods, 20 (9.4%) of the studies reported at least one sex-specific analysis in Results, while in 11 (5.2%) studies sex-related differences were commented in Discussion. Given the quartile of the journal in which the studies were published, there is significantly higher frequency of reporting on sex of the participants in Abstract of the studies published in Q1 and Q2 journals (P = 0.048), and significantly higher frequency of reporting of sex-specific analysis in Results of the studies published in Q1 journals (P = 0.016).
Conclusion: Although RCTs of OSA treatment mostly include both sexes, the percentage of women included, as well as the percentage of the studies which have sex-specific results is small. Since it is known that OSA is a disease in which there are a number of significant differences in symptoms, diagnosis, consequences and treatment between men and women, researchers need to be required to include women in studies, to plan and perform sex-specific analysis, and to interpret sex-related results. Such a practice would allow us to treat OSA in a personalized, i.e. sexually adapted way. |
