Nedovoljna zastupljenost žena u randomiziranim kontroliranim ispitivanjima: sistematski pregled i meta-analiza.
Trials
Sažetak istraživanja
Pozadina Iako je došlo do regulatornih promjena u pravcu ispravljanja nedovoljne zastupljenosti žena u randomiziranim kontroliranim ispitivanjima (RCT) (Nacionalni instituti za zdravlje 1994), postoji zabrinutost oko toga da li je došlo do poboljšanja. U ovom sistematskom pregledu i meta-analizi, imali smo za cilj da procijenimo stope uključenosti žena u nedavne RCT studije i istražimo potencijalne prepreke za upis žena.
Metode RCT objavljene 2017. godine koje ispituju bilo koju vrstu intervencije kod odraslih pretražene su u PubMed-u i Cochrane biblioteci. Uključene su sljedeće unaprijed definisane medicinske oblasti: kardiovaskularne bolesti, neoplazme, bolesti endokrinog sistema, bolesti respiratornog trakta, bakterijske i gljivične infekcije, virusne bolesti, bolesti probavnog sistema i bolesti imunološkog sistema. Studije su nezavisno pregledana od strane dva recenzenta, a jednak broj studija je nasumično odabran po kalendarskom mjesecu. Primarni ishod je bila stopa upisa žena, izračunata kao broj randomiziranih pacijenata podijeljen s ukupnim brojem randomiziranih pacijenata. Stope su ponderisane njihovom inverznom varijansom; statistička značajnost je testirana korištenjem općih linearnih modela (GLM).
Rezultati Od 398 RCT procijenjenih za podobnost, uključeno je 300 RCT. Stopa upisa žena u svim ispitivanim oblastima bila je niža od 50%, osim za bolesti imunog sistema (srednja stopa upisa od 68% (IQR 46 do 81)). Ukupna srednja stopa upisa žena bila je 41% (IQR 27 do 54). Srednja stopa upisa žena smanjila se sa starijom dobi učesnika u ispitivanjima [srednja dob učesnika ispitivanja ≤ 45 godina: 47% (IQR 30-64), 46-55 godina: 46% (IQR 33-58), 56-62 godine: 38% (IQR 0), 38% (IQR 0), ≤IQR 27% 20-46), str
Zaključci Žene su neadekvatno zastupljene, u odabranim medicinskim oblastima analiziranim u našoj studiji, u nedavnim RCT-ima. Starija životna dob potencijalna je prepreka za upis žena u klinička ispitivanja. Niske stope inkluzije starijih žena mogu stvoriti nedostatak ključnog znanja o štetnim efektima i profilu koristi/rizika bilo kojeg liječenja. Faktore koji bi mogli ometati učešće žena treba tražiti i rješavati u dizajnu studije.
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Underrepresentation of women in randomized controlled trials: a systematic review and meta-analysis.
Background Although regulatory changes towards correcting the underrepresentation of women in randomized controlled trials (RCTs) occurred (National Institutes of Health 1994), concerns exist about whether an improvement is taking place. In this systematic review and meta-analysis, we aimed to assess the inclusion rates of women in recent RCTs and to explore the potential barriers for the enrollment of women.
Methods RCTs published in 2017 examining any type of intervention in adults were searched in PubMed and Cochrane Library. The following predefined medical fields were included: cardiovascular diseases, neoplasms, endocrine system diseases, respiratory tract diseases, bacterial and fungal infections, viral diseases, digestive system diseases, and immune system diseases. Studies were screened independently by two reviewers, and an equal number of studies was randomly selected per calendric month. The primary outcome was the enrollment rate of women, calculated as the number of randomized women patients divided by the total number of randomized patients. Rates were weighted by their inverse variance; statistical significance was tested using general linear models (GLM).
Results Out of 398 RCTs assessed for eligibility, 300 RCTs were included. The enrollment rate of women in all the examined fields was lower than 50%, except for immune system diseases [median enrollment rate of 68% (IQR 46 to 81)]. The overall median enrollment rate of women was 41% (IQR 27 to 54). The median enrollment rate of women decreased with older age of the trials' participants [mean age of trials' participants ≤ 45 years: 47% (IQR 30-64), 46-55 years: 46% (IQR 33-58), 56-62 years: 38% (IQR 27-50), ≥ 63 years: 33% (IQR 20-46), p
Conclusions Women are being inadequately represented, in the selected medical fields analyzed in our study, in recent RCTs. Older age is a potential barrier for the enrollment of women in clinical trials. Low inclusion rates of elderly women might create a lack of crucial knowledge in the adverse effects and the benefit/risk profile of any given treatment. Factors that might hinder the participation of women should be sought and addressed in the design of the study.
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- DOI
- 10.1186/s13063-022-07004-2
- PMID
- 36539814
- PMCID
- PMC9768985
- Provjereno
- 2026-07-26
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