The challenges of recruitment in clinical trials in developing countries: the Mycetoma Research Centre experience.

Mycetoma is a chronic disease caused either by fungi (eumycetoma) or bacteria (actinomycetoma). Treatment remains suboptimal and based on personal clinical experience. Recently, the Mycetoma Research Centre (MRC), a WHO Collaborating Centre on mycetoma, began the first-ever double-blind clinical trial. Here, we report the challenges and barriers faced in the recruitment and retention of patients in the MRC experience. Patient recruitment and retention are critical determinants of clinical trial success and yet a substantial number of trials fail to reach their recruitment goals. Recruitment challenges are identified throughout the different stages of the clinical trial, starting from planning, participant screening and intervention, through to retaining participants for the entire study duration. The MRC made efforts to address these challenges to ensure the constant flow of patients. The recruitment committee at the MRC conducted training workshops for the medical staff in the endemic areas, along with regular meetings with health authorities and local leaders. Moreover, telemedicine technology was used to examine patients in endemic areas. Challenges and barriers facing clinical trial conduct need to be examined thoroughly to ensure actionable, evidence-based recommendations for improving patient recruitment and retention. In conclusion, effective patient recruitment and retention are based on three pillars, which are proper clinical trial design and protocol development, realistic and feasible trial site selection, and objective communication with the trial stakeholders.

A holistic approach to the mycetoma management.

Mycetoma, one of the badly neglected tropical diseases, it is a localised chronic granulomatous inflammatory disease characterised by painless subcutaneous mass and formation of multiple sinuses that produce purulent discharge and grains. If untreated early and appropriately, it usually spread to affect the deep structures and bone resulting in massive damage, deformities and disabilities. It can also spread via the lymphatics and blood leading to distant secondary satellites associated with high morbidity and mortality. To date and despite progress in mycetoma research, a huge knowledge gap remains in mycetoma pathogenesis and epidemiology resulting in the lack of objective and effective control programmes. Currently, the available disease control method is early case detection and proper management. However, the majority of patients present late with immense disease and for many of them, heroic substantial deforming surgical excisions or amputation are the only prevailing treatment options. In this communication, the Mycetoma Research Center (MRC), Sudan shares its experience in implementing a new holistic approach to manage mycetoma patients locally at the village level. The MRC in collaboration with Sennar State Ministry of Health, Sudan had established a region mycetoma centre in one of the endemic mycetoma villages in the state. The patients were treated locally in that centre, the local medical and health personals were trained on early case detection and management, the local community was trained on mycetoma advocacy, and environmental conditions improvement. This comprehensive approach had also addressed the patients' socioeconomic constraints that hinder early presentation and treatment. This approach has also included the active local health authorities, community and civil society participation and contributions to deliver the best management. This holistic approach for mycetoma patients' management proved to be effective for early case detection and management, optimal treatment and treatment outcome and favourable disease prognosis. During the study period, the number of patients with massive lesions and the amputation rate had dropped and that had reduced the disease medical and socioeconomic burdens on patients and families.

Hand Mycetoma: The Mycetoma Research Centre Experience and Literature Review.

Mycetoma is a devastating, neglected tropical disease characterised by extensive tissue involvement resulting in destruction, deformities and disabilities in the affected patients. The hand is commonly affected by mycetoma thus compromises its functionality and hinder the patient's daily activities of living. In this communication, we report on 533 patients with hand mycetoma managed over a period of 24 years at the Mycetoma Research Centre, University of Khartoum, Khartoum, Sudan. Eumycetoma was the commonest type of mycetoma (83.3%) encountered. Males were predominately affected (69.2%) with a sex ratio of 2.2:1. The majority of the patients (84%) were young adult below the age of 40 years old at presentation. The generality of patients (86.4%) were from the Sudan mycetoma belt. Children and adolescents (28.1%), farmers (18.2%) and workers (17.4%) were more frequently affected. The majority of patients (67.4%) had disease duration of less than 5 years at presentation. The study, did not document significant history of local trauma, familial tendency, concomitant medical diseases or other predisposing cause for mycetoma in this population. Pain (23.1%) was not a disease feature in this series and 52% of patients had past surgery for mycetoma and recurrence. The right hand was affected most (60.4%), and 64% of them had small lesion at presentation. Conventional x-ray was only helpful in patients with advanced disease and the MRI accurately determined the disease extension. Cytological smears, surgical biopsies histopathological examination and grains culture were the principal diagnostic tools for causative organisms' identification. In the present series it was difficult to determine the treatment outcome due to high patients follow up dropout.