Conducting a Randomized Controlled Trial in Tanzania: Institute for Global Orthopaedics and Traumatology and the Muhimbili Orthopaedic Institute

Abstract

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.

Barriers and Facilitators of Outcome Collection During Hand Surgery Outreach: A Quality Improvement Study

“…The most frequently identified barriers were related to environmental context and resources as well as memory, attention, and decision processes. Our findings not only support previously described barriers 2,[11][12][13][14][15] but also provide an organizational framework within which to understand outcome measure collection and implement change. Commonly cited barriers included the lack of resources of both surgeons (eg, time, administrative support) and patients (eg, time, money, insurance, health, social support) and the lack of an organized, standardized data collection protocol and/or system.…”

“…Semi-structured interview questions were generated based on each domain of the TDF in consultation with experts in TDF, hand surgery outreach, and outcome collection and were informed by previously published research 2,8,11,15,[20][21][22] (Table 1). These questions were adapted to apply to each stakeholder group.…”

“…Interviews of each stakeholder (surgeons, administrative staff, and patients) were conducted until saturation was reached, meaning no new beliefs or attitudes had been elicited, and in accordance with accepted methodology. 15,19,24 All transcripts were transcribed for data analysis; patient identifiers were removed, and all records and transcripts were stored ensuring Health Insurance Portability and Accountability Act compliance.…”

“…This may be due to several barriers (eg, cost constraints, difficulty in locating patients) or influenced by facilitators (eg, short surveys, electronic survey implementation). 2,[11][12][13][14][15] As such, identifying determinants of behavior that influence the collection of outcomes is a recommended step to develop interventions and tools to ensure patient safety and high-quality care. [16][17][18] Our purpose was to describe this process to inform quality improvement efforts, in addition to developing methods for other organizations similarly prioritizing patient outcome collection.…”

A pilot, masked, randomized controlled trial to evaluate local gentamicin versus saline in open tibial fractures (pGO-Tibia)

“…MOI is a tertiary referral hospital in the largest city in Tanzania. [23] The study protocol was previously published [22] in accordance with the Standard Protocol Items: Recommendation for Interventional Trials (SPIRIT) [24] and Consolidated Standards of Reporting Trials (CONSORT) [25] guidelines for randomized pilot and feasibility trials and was registered at ClinicalTrials.gov (NCT03559400). [26] The pGO-Tibia trial received funding from the Orthopaedic Trauma Association International Grant, the Hellman Fellows Fund as part of the UCSF Hellman Fellowship Program, and the UCSF Department of Orthopaedic Surgery.…”