The participation of Arab women in randomised clinical trials for cardiovascular diseases.

ABSTRACT

INTRODUCTION: Women's enrolment in randomised clinical trials (RCTs) raises the attention of medical personnel and evidence-based medicine researchers to achieve the highest possible quality and transparency of conducted studies. This study aims to demonstrate various patterns and relationships of women's enrolment in cardiovascular RCTs conducted in Arab countries. MATERIALS AND METHODS: Three databases (PubMed, Web of Science and Scopus) were accessed and searched for randomised clinical trials investigating cardiovascular diseases in Arab countries. Studies were screened, data were extracted and risk of bias of included studies was assessed independently by two sets of authors. The female to male ratio and the participation prevalence ratio (PPR) were calculated for each trial and the association of them with different variables were analysed. RESULTS AND DISCUSSION: Of the 9071 patients enrolled in the 71 included RCTs, 38.02% were women. Various factors such as age of participants, publication year, therapeutic class, clinical indication, prevention type, and location of trial showed a significant association with the level of women enrolment in cardiovascular randomised clinical trials in Arab countries (P-value < .05). The median female to male ratio of all the trials was 0.55. The median female male ratio varied by clinical indications (2.33 for valvular heart diseases vs 0.5 for stroke), intervention type (0.46 for surgical procedures vs 0.52 for drugs), prevention type (0.79 for secondary prevention, 0.74 for primary prevention and 0.52 for tertiary prevention), sample size (0.48 for Q1 vs 0.85 for Q2) and by age groups (0.98 for ages ≤50 years old vs 0.47 for 56-60 years old). Women were overrepresented in valvular heart disease trials (PPR = 1.37), and underrepresented in coronary artery disease, stroke and atrial fibrillation trials (PPR = 0.6, 0.63, and 0.71, respectively). CONCLUSION: As a result of the huge importance of RCTs in the medical field, and to reduce biases arising from inaccurate representation of different study populations, women's enrolment in Arab cardiovascular trials should be pre-planned and based on the percentage of women among the studied disease population.