Research & Ethics Committee

Permanent URI for this community

https://rscarchive.kuhes.ac.mw/handle/20.500.12988/202

Browse

Browsing Research & Ethics Committee by Subject "Assessing the change in bleeding rates and related clinical outcomes in haemophilia patients"

Now showing 1 - 1 of 1
  • Thumbnail Image
    Item
    Restricted
    Assessing the change in bleeding rates and related clinical outcomes in haemophilia patients before and after introducing Humanitarian Aid factor concentrates in Malawi
    (Kamuzu University of Health Sciences, 2022-08-05) Mkwenembere, Francis
    Type of study This study will be a retrospective cohort that will use existing de-identified data from the WBDR to be obtained from an observational study of a larger COMREC approved haemophilia cohort study titled “Health-related quality of life in haemophilia patients in Malawi” (P.02/19/2612) which is being conducted by the Society of Haemophilia and Allied Disorders (SHAD). Study problem There is data paucity on haemophilia in Malawi. Literature review showed that many research studies were done in high income countries that mostly focused on comparison of treatment modalities of prophylaxis and on demand. The Malawi NCDI Commission 2018 Report lacked representation of haemophilia disease suggesting limited data of haemophilia research in Malawi. Objectives This study aims at assessing the change in bleeding rates and related clinical outcomes in haemophilia patients before and after introducing clotting factor concentrates in Malawi. Specifically, it will assess the change of annual bleeding rates before and after clotting factor concentrates, compare the quality of life before and after exposure of factor clotting factor concentrates and estimate the difference regarding days lost to work or school before and after clotting concentrates Methodology Data will be analysed using Stata 15 and continuous variables will be summarised either using Mean/Standard deviation or median/interquartile range depending on the normality. Wilcoxon Rank Sum Test will be used for comparison with a p-value of <0.05 considered statistically significant. Expected findings The study is expected to reveal any difference in bleeding rates, quality of life and improved clinical outcomes between the time prior and after the introduction of use of factor concentrates in Malawi. Dissemination Results will be shared with COMREC, Kamuzu University of Health Sciences, WFH, SHAD, and Ministry of Health through the Department of Non-Communicable Diseases. The results will also be disseminated through various symposia and will be submitted for publication in peer-reviewed journals.