Conducting a Randomized Controlled Trial in Tanzania: Institute for Global Orthopaedics and Traumatology and the Muhimbili Orthopaedic Institute
| Autor: | Kurt Yusi, Saam Morshed, Billy T Haonga, Max Liu, Edmund N Eliezer, David W. Shearer, John Ibrahim |
|---|---|
| Rok vydání: | 2018 |
| Předmět: |
Adult
Male medicine.medical_specialty Adolescent External Fixators medicine.medical_treatment Traumatology Pilot Projects Tanzania law.invention Intramedullary rod 03 medical and health sciences External fixation Young Adult 0302 clinical medicine Dar es salaam Randomized controlled trial law Fracture Fixation medicine Humans Orthopedics and Sports Medicine Prospective Studies Orthopaedic trauma Developing Countries Aged Randomized Controlled Trials as Topic 030222 orthopedics biology business.industry 030208 emergency & critical care medicine General Medicine Middle Aged biology.organism_classification medicine.disease Fracture Fixation Intramedullary Tibial Fractures Research Design Orthopedic surgery Surgery Female Medical emergency business |
| Zdroj: | Journal of orthopaedic trauma. 32 |
| ISSN: | 1531-2291 |
| Popis: | INTRODUCTION Low- and middle-income countries (LMICs) experience a large volume of orthopaedic trauma, but limited research exists to evaluate effective treatments using locally available means. Academic partners can help design and implement research studies through collaborative efforts with local investigators. We will describe the study design and lessons learned from a randomized controlled trial in Tanzania comparing outcomes of 2 operative treatments for open tibia fractures. STUDY DESIGN The Institute for Global Orthopaedics and Traumatology at the University of California, San Francisco, and the Muhimbili Orthopaedic Institute in Dar es Salaam, Tanzania, partnered to design a prospective, randomized controlled trial. Adult patients with open tibia fractures were randomized to receive either intramedullary nailing or external fixation as definitive fixation. Our primary outcome was the rate of reoperation, and secondary outcomes included EQ-5D, pain, function, radiographic union, and return to work. RESULTS We enrolled 40 patients in a pilot study that informed improvements in the study design and standard operating procedures. These modifications included development of a specific outline of the technical standards for each surgical intervention and held training workshops to disseminate this knowledge among operative surgeons. This resulted in the successful enrollment and standardized treatment of our target sample of 240 patients. DISCUSSION There are several challenges in conducting high-quality, international research. Keys for success include maintaining a strong relationship between partners, having local research coordinators, simplifying data collection and storage, and incentivizing patients to attend follow-up visits. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|