Barriers to and Outcomes of Initiating Clinical Research at Two Trauma Centers in Mexico.

INTRODUCTION: Despite efforts to advance clinical research through collaboration between Latin and North American partners, there remains persistent barriers to performing investigative work. To overcome these obstacles, a team of over 100 surgeon-leaders from 18 Latin American countries founded the Asociación de Cirujanos Traumatólogos de las Américas (ACTUAR). One of ACTUAR's first major collaborative projects, initiated in 2018, was a prospective, observational, multicenter study evaluating quality of life after open tibia fracture management. The current study identified common barriers experienced during the initiation of this study, as exemplified through two sites in Mexico. The study aims to identify obstacles to proactively overcome these in future collaborative work. METHODS: Two research assistants from University of California, San Francisco and two research coordinators from Mexico were recruited to share their experiences, identify common barriers experienced during site enrollment and on-boarding for the ACTUAR open tibia study, and discuss possible solutions. RESULTS: Barriers were organized into three categories: structural, logistical, and intrapersonal. Structural barriers included differences in patient populations and resources between private and public hospitals. Logistical barriers included ambiguous ethical review processes, internet availability, and low patient follow-up. Primary enrollment as a resident responsibility led to some intrapersonal barriers. Potential solutions were identified for each barrier and agreed upon by all collaborators. CONCLUSIONS: Multiple barriers were identified by research personnel who initiated a prospective surgical clinical research study in Mexico. Through collaborative approaches, many potential solutions may help overcome these barriers and build locally led research capacity in Latin America.

Manejo de fracturas abiertas de tibia en Cuba / Management of Open Tibial Fractures in Cuba

Introducción: Las fracturas abiertas de tibia son un subconjunto de la carga de traumatismos en América Latina. Se examinaron cuestiones relacionadas con el tratamiento potencialmente críticas en Cuba, país con recursos limitados, pero con un programa nacional de salud estandarizado, coherencia en educación y similitudes de programas de posgrado. Objetivos: Describir los patrones de tratamiento de la fractura abierta de tibia en Cuba, y comparar las características del manejo agudo y tardío en siete provincias del país. Métodos: Se encuestaron 67 cirujanos ortopédicos para evaluar cuatro aspectos en el tratamiento de la fractura abierta: profilaxis antibiótica, irrigación y desbridamiento, estabilización y tratamiento de heridas. Se utilizó el método de muestreo por conveniencia para identificar a los cirujanos y el análisis se realizó mediante la prueba exacta de Fisher (p < 0,05). Resultados: Se administraron antibióticos posoperatorios durante más de 72 horas para las fracturas GA-I/II (49 por ciento) y las fracturas GA-III (70 por ciento). Los cirujanos de La Habana (n= 32) utilizaron con más frecuencia la fijación interna primaria para las fracturas GA-I/II, que los cirujanos en las restantes provincias (n= 35) (64,3 porciento vs. 30,3 por ciento, p= 0,008). Los cirujanos de otras provincias realizaron cierre primario en el momento de la fijación definitiva de fracturas GA-I /II con más frecuencia que los de La Habana (62,9 por ciento vs. 32,3 por ciento, p= 0,013). Para fracturas GA-III, la mayoría de los cirujanos habaneros (88,6 %), al igual que los de las restantes provincias (96,8 por ciento) prefirieron realizar cierre diferido.Conclusiones: El tratamiento de fracturas abiertas de tibia en Cuba es generalmente consistente con otros países de América Latina. Se describen las características del manejo de fracturas abiertas de tibia en Cuba y se comparan las diferencias en los métodos de estabilización y tratamiento de heridas entre provincias, lo cual resulta útil para evaluar si son resultado de diferencias en la práctica quirúrgica, o en la disponibilidad de recursos. Esto representa una ayuda al abordar las formas de optimizar la atención al paciente, a través de la capacitación especializada y la asignación de los recursos(AU)

Introduction: Open tibia fractures are a significant subset of the overall trauma burden in Latin America. Latin American countries vary in their access to orthopaedic care resources, and country-specific orthopaedic recommendations are necessary. Cuba, a country with limited resources, has a standardized national health program, consistencies in education, and similarities across post-graduate training programs. This study aimed to identify management preferences for open tibia factures in Cuba. Objectives: To describe the treatment of open tibial fractures in Cuba, and to compare the characteristics of acute and delayed management across seven Cuban provinces. Methods: Sixty-seven orthopaedic surgeons were surveyed to evaluate four aspects of open fracture management, regarding antibiotic prophylaxis, irrigation and debridement, stabilization, and wound management. The convenience sampling method was used to identify surgeons and the analysis was performed using Fisher's exact test (p <0.05). Results: Postoperative antibiotics were administered for more than 72 hours for GA-I / II fractures (49 pecent) and GA-III fractures (70 percent). Surgeons in Havana (n = 32) used primary internal fixation for GA-I / II fractures more frequently than surgeons in the remaining provinces (n = 35) (64.3 pecent vs. 30.3 percent p = 0.008). Surgeons from other provinces performed primary closure at the time of definitive fixation of GA-I / II fractures more frequently than those from Havana (62.9 percent vs. 32.3 percent, p = 0.013). For GA-III fractures, the majority of Havana surgeons (88.6 percent), as well as those of the remaining provinces (96.8 percent) preferred to perform deferred closure. Conclusions: The treatment of open tibial fractures in Cuba is generally consistent with other Latin American countries. The characteristics of the management of open tibial fractures in Cuba are described and differences in wound stabilization and treatment methods between provinces are compared, which is useful to assess whether they are the result of differences in surgical practice, or in availability of resources. This is helpful in addressing ways to optimize patient care through specialized training and resource allocation(AU)

Motivations and impact of international rotations in low- and middle-income countries for orthopaedic surgery residents: Are we on the same page?

BACKGROUND: Despite interest among North American orthopaedic residents to pursue rotations in resource-limited settings, little is known regarding resident motivations and impact on host surgeons. METHODS: Surveys were distributed to North American orthopaedic surgeons and trainees who participated in international rotations during residency to assess motivations for participation and to orthopaedic surgeons at partnering low- and middle-income country (LMIC) institutions to assess impact of visiting trainees. RESULTS: Responses were received from 136 North American resident rotators and 51 LMIC host surgeons and trainees. North American respondents were motivated by a desire to increase surgical capacity at the LMIC while host surgeons reported a greater impact from learning from residents than on surgical capacity. Negative aspects reported by hosts included selfishness, lack of reciprocity, racial discrimination, competition for surgical experience, and resource burdens. CONCLUSIONS: The motivations and impact of orthopaedic resident rotations in LMICs need to be aligned. Host perceptions and bidirectional educational exchange should be incorporated into partnership guidelines.

Open Tibial Shaft Fractures: Treatment Patterns in Latin America.

BACKGROUND: Open tibial shaft fractures are an important source of disability in Latin America. High-income countries (HICs) worldwide have established standardized treatment protocols for open tibial fractures, but less is known about their treatment in middle-income countries (MICs) in Latin America. This survey of Latin American orthopaedic surgeons characterizes open tibial fracture treatment patterns. METHODS: Orthopaedic surgeons from 20 national orthopaedic societies throughout Latin America completed an online survey assessing their treatment of open tibial fractures. Demographic information was collected. Treatment patterns were queried according to 2 groupings of Gustilo-Anderson (GA) fracture types: treatment of type-I and type-II fractures (GA-I/II) and treatment of type-III fractures (GA-III). Treatment patterns were evaluated across 4 domains: antibiotic prophylaxis, irrigation and debridement, fracture stabilization, and wound management. Summary statistics were reported; analysis was performed using the Fisher exact test (p < 0.05). RESULTS: There were 616 survey participants from 20 Latin American countries (4 HICs and 16 MICs). Initial external fixation followed by staged internal fixation was preferred for GA-I/II (51.0%) and GA-III fractures (86.0%). Nearly one-third (31.5%) of GA-IIIB fractures did not receive a soft-tissue coverage procedure. Stratifying by country socioeconomic status, surgeons in MICs more commonly utilized delayed internal fixation for GA-I/II (53.3% versus 22.0%, p < 0.001) and GA-III fractures (94.0% versus 80.4%, p = 0.002). Surgeons in MICs more commonly used primary closure for GA-I/II (88.9% versus 62.8%, p < 0.001) and GA-III fractures (32.6% versus 9.8%, p < 0.001). CONCLUSIONS: This survey reports Latin American orthopaedic surgeons' treatment patterns for open tibial shaft fractures. Surgeons in MICs reported higher delayed internal fixation use for all fracture types, while surgeons in HICs more routinely avoid primary closure. Soft-tissue coverage procedures are not performed in nearly one-third of GA-IIIB fractures because of a lack of operative personnel and training.

Delays to Surgery and Coronal Malalignment Are Associated with Reoperation after Open Tibia Fractures in Tanzania.

BACKGROUND: Treatment of diaphyseal open tibia fractures often results in reoperation and impaired quality of life. Few studies, particularly in resource-limited settings, have described factors associated with outcomes after these fractures. QUESTIONS/PURPOSES: (1) Which patient demographic, perioperative, and treatment characteristics are associated with an increased risk of reoperation after treatment of open tibia fractures with intramedullary nailing or an external fixation device in Tanzania? (2) Which patient demographic, perioperative, and treatment characteristics are associated with worse 1-year quality of life after treatment of open tibia fractures with intramedullary nailing or an external fixation device in Tanzania? METHODS: A prospective study was completed in parallel to a similarly conducted RCT at a tertiary referral center in Tanzania that enrolled adult patients with diaphyseal open tibia fractures from December 2015 to March 2017. Patients were treated with either a statically locked intramedullary nail or external fixator and examined at 2 weeks, 6 weeks, 3 months, 6 months, and 1 year postoperatively. The primary outcome, reoperation, was any deep infection or nonunion treated with a secondary intervention. The secondary outcome was the 1-year EuroQol-5D (EQ-5D) index score. There were 394 patients screened and ultimately, 267 patients enrolled in the study (240 from the primary RCT and 27 followed for the purposes of this study). Of these, 90% (240 of 267) completed 1-year follow-up and were included in the final analysis. This group comprised 110 patients who underwent IMN and 130 who had external fixation; follow-up was similar between study groups. Patients were an average of 33 years old and were primarily males who sustained road traffic injuries resulting in AO/Orthopaedic Trauma Association (OTA) classification type A or B fractures. There were 51 reoperations. For the purposes of analysis, all patients were pooled to identify all other factors, in addition to treatment type, associated with increased risk of reoperation and 1-year quality of life. An exploratory bivariable analysis identifying various factors associated with reoperation risk and EQ-5D was subsequently included in a multivariate modeling procedure to control for confounding of effect on our primary outcome. Multivariable modeling was performed using standard hierarchical modeling simplification procedures with log-likelihood ratios. Alpha levels were set to 0.05. RESULTS: After controlling for potentially confounding variables such as gender, smoking status, mechanism of injury, and treatment type, the following factors were independently associated with reoperation: Time from hospital presentation to surgery more than 24 hours (odds ratio 7.7 [95% confidence interval 2.1 to 27.8; p = 0.002), AO/OTA fracture classification Type 42C fracture (OR 4.2 [95% CI 1.2 to 14.0]; p = 0.02), OTA-Open Fracture Classification muscle loss (OR 7.5 [95% CI 1.3 to 42.2]; p = 0.02), and varus coronal angle on an immediate postoperative AP radiograph (OR 4.8 [95% CI 1.2 to 14.0]; p = 0.002). After again controlling for confounding variables such as gender, smoking status, mechanism of injury, and treatment type factors independently associated with worse 1-year EQ-5D scores included: Wound length ≥ 10 cm (ß = [change in EQ-5D score] -0.081 [95% CI -0.139 to -0.023]; p = 0.006), OTA-Open Fracture Classification muscle loss (ß = -0.133 [95% CI -0.215 to -0.051]; p = 0.002), and OTA-Open Fracture Classification bone loss (ß = -0.111 [95% CI -0.208 to -0.013]; p = 0.03). We observed a modest, but independent association between reoperation and worse 1-year EQ-5D scores (ß = -0.113 [95% CI -0.150 to -0.077]; p < 0.001). CONCLUSIONS: We found two potentially modifiable factors associated with the risk of reoperation: reducing time to surgical treatment and avoiding varus coronal angulation during definitive stabilization. Hospitals may be able to minimize time to surgery, and thus, reoperation, by increasing the number of available operative personnel and space and emphasizing the importance of open tibia fractures as an injury requiring emergent orthopaedic management. Given the lack of fluoroscopy in the study setting and similar settings, surgeons should emphasize appropriate fracture alignment, even into slight valgus, to avoid varus angulation and subsequent reoperation risk. LEVEL OF EVIDENCE: Level II, therapeutic study.

Travel barriers, unemployment, and external fixation predict loss to follow-up after surgical management of lower extremity fractures in Dar es Salaam, Tanzania.

OBJECTIVE: Predict loss to follow-up in prospective clinical investigations of lower extremity fracture surgery. DESIGN: Secondary analysis of 2 prospective clinical trials. SETTING: National public orthopaedic and neurologic trauma tertiary referral hospital in Dar es Salaam, Tanzania, a low-income country in sub-Saharan Africa. PATIENTS/PARTICIPANTS: Three hundred twenty-nine femoral shaft and 240 open tibial shaft fracture patients prospectively enrolled in prospective controlled trials of surgical fracture management by external fixation, plating, or intramedullary nailing between June 2015 and March 2017. INTERVENTION: Telephone contact for failure to attend scheduled 1-year clinic visit. MAIN OUTCOME MEASUREMENTS: Ascertainment of primary trial outcome at 1-year from surgery; post-hoc telephone questionnaire for reasons patient did not attend the 1-year clinic visit. RESULTS: One hundred twenty-seven femur fracture (39%) and 68 open tibia fracture (28%) patients did not attend the 1-year clinic visit. Telephone contact significantly improved ascertainment of the primary study outcome by 20% between 6-month and 1-year clinic visits to 82% and 92% respectively at study completion. Multivariable analysis associated unemployment (OR = 2.5 [1.7-3.9], P < .001), treatment with an external fixator (OR = 1.7 [1.0-2.8], P = .033), and each additional 20 km between residence and clinic (OR = 1.03 [1.00-1.06], P = .047] with clinic nonattendance. One hundred eight (55%) nonattending patients completed the telephone questionnaire, reporting travel distance to the hospital (49%), and travel costs to the hospital (46%) as the most prevalent reasons for nonattendance. Sixty-five percent of patients with open tibia fractures cited relocation after surgery as a contributing factor. CONCLUSIONS: Relocation during recovery, travel distance, travel cost, unemployment, and use of an external fixator are associated with loss to clinical follow-up in prospective investigations of femur and open tibia fracture surgery in this population. Telephone contact is an effective means to assess outcome.

The Impact of Inadequate Soft-tissue Coverage following Severe Open Tibia Fractures in Tanzania.

Managing lower extremity fractures complicated by large soft-tissue defects is challenging for surgeons in low- and middle-income countries, and long-term quality of life (QOL) for these patients is unclear. METHODS: We examined QOL, surgical complications, and longitudinal outcomes in 10 patients with Gustilo-Anderson Classification Type IIIB open tibia fractures seen at an orthopedic institute in Tanzania, from December 2015 to March 2017. Patients completed follow-up at 2-, 6-, 12-, 26-, and 52-week time points, and returned for qualitative interviews at 2.5 years. The primary outcome was QOL, as measured using EuroQoL-5D scores and qualitative semi-structured interview responses. The secondary outcome was rate of complication, as defined by reoperation for deep infection or nonunion. RESULTS: Ten patients enrolled in the study and 7 completed 1-year follow-up. All fractures were caused by road traffic accidents and treated by external fixation. No patients received initial soft-tissue (flap) coverage of the wound. All patients developed an infected nonunion. No patients returned to work at 6 weeks, 3 months, or 6 months. EQ-5D index scores at 1 year were poor (0.71 ± 0.09). Interview themes included ongoing medical complications, loss of employment, reduced income, and difficulty with activities of daily living. CONCLUSIONS: Patients in low- and middle-income countries with IIIB open tibia fractures not treated with appropriate soft-tissue coverage experience poor QOL, high complication rates, and severe socioeconomic effects as a result of their injuries. These findings illustrate the need for resources and training to build capacity for extremity soft-tissue reconstruction in LMICs.

Knowledge deficits and barriers to performing soft-tissue coverage procedures: An analysis of participants in an orthopaedic surgical skills training course in Mexico.

BACKGROUND: An increasing number of traumatic injuries in low- and low-middle-income countries (LICs/LMICs) have coexisting injuries requiring soft-tissue coverage (flaps). Yet, there is a lack of subspecialty care and flap training in Latin America. This study assesses the effectiveness of a surgical skills training course in improving rotational and free flap knowledge and identifies barriers to performing these types of flaps. METHODS: Participants attending a surgical skills training course in Guadalajara, Mexico completed a pre/postcourse flaps knowledge survey consisting of 15 questions from the plastic surgery in-training examination and also completed a 7-point Likert survey regarding perceived barriers to performing flaps at their institution. RESULTS: Of the course participants, 17 (44.7%) completed the precourse knowledge survey, 24 (63.2%) completed the postcourse survey, and 37 (97.4%) completed the barriers survey. Scores improved from pre- to postcourse knowledge surveys (39.6% to 53.6%, P = .005). Plastic surgery subsection scores also improved (39.0% to 60.4%, P = .003). Twenty-five percent of attendees received prior flap training and had plastic surgeons available to perform flaps. Few participants (38.9%) reported flap procedures being commonly completed at their hospitals. Participants stating that flaps were uncommon in their hospital reported more institutional barriers and less access to dermatomes. These participants also reported lack of operating room and surgical personnel availability. CONCLUSION: A surgical skills training course may be useful in improving knowledge of soft-tissue coverage procedures. There are also modifiable physician and institutional barriers that can improve the ability to perform rotational and free flaps as identified by the course participants.