Tips and tricks for successfully conducting a multicenter study. / Reglas y consejos para desarrollar con éxito un estudio multicéntrico.

Multicenter studies play a crucial role in medical research and advancement, facilitating the application of new knowledge to clinical practice. These studies are associated with multiple benefits but are more complex than those involving a single center. With the philosophy that most of the qualities required to lead a multicenter study depend on attitude and can be learned, developed, and improved, in this manuscript, we share with the reader a series of recommendations that we consider important for successfully conducting such studies. The tips and tricks that will be discussed in detail are as follows: effectively leading the project; clearly defining viable and relevant objectives; designing a clear and detailed protocol; carefully selecting centers and collaborating investigators; meticulously designing the case report form; centrally managing the project efficiently; maintaining fluent communication with investigators; and, finally, designing a clear authorship policy and ensuring the appropriate publication of the study results. We hope that these suggestions encourage potential researchers to conduct multicenter studies, thereby collectively enhancing the quality of research and its application to clinical practice.

[Antimicrobial susceptibility of Escherichia coli producers of community urinary tract infections in Galicia (Spain). Period: 2016-2017]. / Estudio de sensibilidad de Escherichia coli productores de infecciones del tracto urinario comunitarias en Galicia. Período: 2016-2017.

OBJECTIVE: Escherichia coli (E. coli) is responsible for the majority of community urinary tract infections. The objective of the study is to know the sensitivity spectrum of E. coli in urinary tract infections to be able to recommend the appropriate empirical antibiotic treatment. DESIGN: Cross-sectional, multicentric, retrospective study. LOCATION: Galician 8 public hospitals, practically the entire population of Galicia (Spain). PARTICIPANTS: 43,137 outpatients with urinary tract infection due to E. coli isolated in urine in 2016/2017. MAIN MEASUREMENTS: Analyzed variables: demographic, minimum inhibitory concentration and interpretation of sensitivity according to CLSI criteria and resistance mechanisms. The antibiotics studied were: ampicillin, amoxicillin-clavulanic acid, ciprofloxacin, cefotaxime, cefepime, gentamicin, nitrofurantoin, fosfomycin, cotrimoxazole, imipenem and ertapenem. The identification and sensitivity were made mainly by automated methods. RESULTS: The percentages of non-sensitivity of E. coli isolates were: ampicillin 49.2%, amoxicillin-clavulanic acid 17.8%, cefotaxime 6.7%, cefepime 5.7%, ertapenem 0.04%, imipenem 0.05%, gentamicin 9,1%, ciprofloxacin 26.2%, fosfomycin 3.3%, nitrofurantoin 2.4% and cotrimoxazole 23.9%. The non-sensitivities were higher in men and as age increases. Six percent of E. coli were producers of extended-spectrum beta-lactamases. CONCLUSIONS: The empirical treatment in Galicia for uncomplicated cystitis produced by E. coli in women continues to be nitrofurantoin and fosfomycin. In men under 15 years of age, fosfomycin is indicated and in men older than 15 years, treatment in our environment should include culture and administer a 3rd generation oral cephalosporin empirically. Cotrimoxazole and ciprofloxacin are not recommended as empirical treatment because of their high resistance rates.

Analysis of adverse events in general surgery. Multicenter study.

INTRODUCTION: Knowledge of adverse events (AE) in acute care hospitals is a particularly relevant aspect of patient safety. Its incidence ranges from 3% to 17%, and surgery is related to the occurrence of 46%-65% of all AE. MATERIAL AND METHODS: An observational, descriptive, retrospective, multicenter study was conducted with the participation of 31 Spanish acute-care hospitals to determine and analyze AE in general surgery services. RESULTS: The prevalence of AE was 31.53%. The most frequent types of AE were infectious (35%). Higher ASA grades, greater complexity and urgent-type admission are factors associated with the presence of AE. The majority of patients (58.42%) were attributed a category F event (temporary harm to the patient requiring initial or prolonged hospitalization); 14.69% of AE were considered severe, while 34.22% of AE were considered preventable. CONCLUSIONS: The prevalence of AE in General and GI Surgery (GGIS) patients is high. Most AE were infectious, and the most frequent AE was surgical site infection. Higher ASA grades, greater complexity and urgent-type admission are factors associated with the presence of AE. Most detected AE resulted in mild or moderate harm to the patients. About one-third of AE were preventable.

Spinal gunshot wounds: A retrospective, multicenter, cohort study. / [Artículo traducido] Lesiones vertebrales por proyectil de arma de fuego: estudio de cohorte retrospectivo, multicéntrico.

INTRODUCTION AND OBJECTIVE: To describe the demographic and clinical characteristics and treatment of patients with spinal gunshot wounds across Latin America. MATERIAL AND METHODS: Retrospective, multicenter cohort study of patients treated for gunshot wounds to the spine spanning 12 institutions across Latin America between January 2015 and January 2022. Demographic and clinical data were recorded, including the time of injury, initial assessment, characteristics of the vertebral gunshot injury, and treatment. RESULTS: Data on 423 patients with spinal gunshot injuries were extracted from institutions in Mexico (82%), Argentina, Brazil, Colombia, and Venezuela. Patients were predominantly male civilians in low-risk-of-violence professions, and of lower/middle social status, and a sizeable majority of gunshots were from low-energy firearms. Vertebral injuries mainly affected the thoracic and lumbar spine. Neurological injury was documented in 320 (76%) patients, with spinal cord injuries in 269 (63%). Treatment was largely conservative, with just 90 (21%) patients treated surgically, principally using posterior open midline approach to the spine (79; 87%). Injury features distinguishing surgical from non-surgical cases were neurological compromise (P = 0.004), canal compromise (P < 0.001), dirty wounds (P < 0.001), bullet or bone fragment remains in the spinal canal (P < 0.001) and injury pattern (P < 0.001). After a multivariate analysis through a binary logistic regression model, the aforementioned variables remained statistically significant except neurological compromise. CONCLUSIONS: In this multicenter study of spinal gunshot victims, most were treated non-surgically, despite neurological injury in 76% and spinal injury in 63% of patients.

Safety and efficacy of a new supplementation protocol in patients with cystic fibrosis and vitamin D deficiency.

OBJECTIVES: Based on the European and American Cystic Fibrosis (CF) consensus recommendations, an increase in vitamin D (VD) supplementation in patients with CF and insufficient or defficient levels was proposed. The objective of our study was to determine the safety and efficacy of this new protocol. MATERIAL AND METHODS: Multicentre nonrandomized uncontrolled experimental study. Patients with insufficient levels (<30 ng/mL) received increasing doses of VD (between 800 and 10 000 IU/day). Patients were followed up for 12 months, during which their vitamin and nutritional status, pulmonary function and calcium and phosphate metabolism were assessed. STATISTICAL ANALYSIS: t test for paired data and multivariate logistic regression analysis. RESULTS: Thirty patients aged 1-39 years (median, 9.1) completed the follow-up. Two patients were dropped from the study on account of 25-OH VD levels greater than 100 ng/mL at 3 months without clinical or laboratory signs of hypercalcaemia. At 12 months, we observed an increase of 7.6 ng/mL (95% CI, 4.6-10 ng/mL) in the mean 25-OH VD level and an improvement in vitamin status: 37% achieved levels of 30 ng/mL or greater, 50% levels between 20 and 30 ng/mL and 13% remained with levels of less than 20 ng/mL. We found no association between improved VD levels and pulmonary function. CONCLUSIONS: The proposed protocol achieved an increase in serum VD levels and a decrease in the percentage of patients with VD insufficiency, although it was still far from reaching the percentages of sufficiency recommended for this entity.

Protocolization of multicenter clinical studies in the digital era. Is useful data centralization by a data-manager?

INTRODUCTION: In multicenter studies, the protocolization of data is a critical phase that can generate biases.The objective is to analyze the concordance and reliability of the data obtained in a clinical multicenter study between the protocolization in the center of origin and the centralized protocolization of the data by a data -manager. METHODS: National multicenter clinical study about an infrequent carcinoma. A double protocolization of the data is carried out: (a) center of origin; and (b) centralized by a data manager: The concordance between the data is analyzed for the global data and for the two groups of the project: (a) study group (Familiar carcinoma, 30 researchers protocolize); (b) control group (Sporadic carcinoma, 4 people protocolize). Interobserver variability is evaluated using Cohen's kappa coefficient. RESULTS: The study includes a total of 689 patients with carcinoma, 252 in the study group and 437 in the control group. Regarding the concordance analysis of the tumor stage, 2.5% of disagreements were observed and the concordance between people who protocolize was near perfect (Kappa = 0.931). Regarding the evaluation of the recurrence risk, disagreements occurred in 7% of the cases and the concordance was near perfect (Kappa = 0.819). Regarding the sonography evaluation (TIRADS), the disagreements were 6.9% and the concordance was near perfect (Kappa = 0.922). Also, 4.6% of transcription errors were detected. CONCLUSIONS: In multicenter clinical studies, the centralized data protocolization o by a data-manager seems to present similar results to the direct protocolization in the database in the center of origin.

Spinal gunshot wounds: A retrospective, multicenter, cohort study.

INTRODUCTION AND OBJECTIVE: To describe the demographic and clinical characteristics and treatment of patients with spinal gunshot wounds across Latin America. MATERIAL AND METHODS: Retrospective, multicenter cohort study of patients treated for gunshot wounds to the spine spanning 12 institutions across Latin America between January 2015 and January 2022. Demographic and clinical data were recorded, including the time of injury, initial assessment, characteristics of the vertebral gunshot injury, and treatment. RESULTS: Data on 423 patients with spinal gunshot injuries were extracted from institutions in Mexico (82%), Argentina, Brazil, Colombia, and Venezuela. Patients were predominantly male civilians in low-risk-of-violence professions, and of lower/middle social status, and a sizeable majority of gunshots were from low-energy firearms. Vertebral injuries mainly affected the thoracic and lumbar spine. Neurological injury was documented in n=320 (76%) patients, with spinal cord injuries in 269 (63%). Treatment was largely conservative, with just 90 (21%) patients treated surgically, principally using posterior open midline approach to the spine (n=79; 87%). Injury features distinguishing surgical from non-surgical cases were neurological compromise (p=0.004), canal compromise (p<0.001), dirty wounds (p<0.001), bullet or bone fragment remains in the spinal canal (p<0.001) and injury pattern (p<0.001). After a multivariate analysis through a binary logistic regression model, the aforementioned variables remained statistically significant except neurological compromise. CONCLUSIONS: In this multicenter study of spinal gunshot victims, most were treated non-surgically, despite neurological injury in 76% and spinal injury in 63% of patients.

Reporting antimicrobial susceptibilities and phenotypes of resistance to vancomycin in vancomycin-resistant Enterococcus spp. clinical isolates: A nationwide proficiency study.

INTRODUCTION: The ability of Spanish microbiology laboratories to (a) determine antimicrobial susceptibility (AS), and (b) correctly detect the vancomycin resistance (VR) phenotype in vancomycin-resistant Enterococcus spp. (VRE) was evaluated. METHODS: Three VRE isolates representing the VanA (E. faecium), VanB (E. faecium) and VanC (E. gallinarum) VR phenotypes were sent to 52 laboratories, which were asked for: (a) AS method used; (b) MICs of ampicillin, imipenem, vancomycin, teicoplanin, linezolid, daptomycin, ciprofloxacin, levofloxacin and quinupristin-dalfopristin, and high-level resistance to gentamicin and streptomycin; (c) VR phenotype. RESULTS: (a) The most frequently used system was MicroScan; (b) according to the system, the highest percentage of discrepant MICs was found with gradient strips (21.3%). By antimicrobial, the highest rates of discrepant MICs ranged 16.7% (imipenem) to 0.7% (linezolid). No discrepant MICs were obtained with daptomycin or levofloxacin. Mayor errors (MEs) occurred with linezolid (1.1%/EUCAST) and ciprofloxacin (5.0%/CLSI), and very major errors (VMEs) with vancomycin (27.1%/EUCAST and 33.3%/CLSI) and teicoplanin (5.7%/EUCAST and 2.3%/CLSI). For linezolid, ciprofloxacin, and vancomycin, discrepant MICs were responsible for these errors, while for teicoplanin, errors were due to a misassignment of the clinical category. An unacceptable high percentage of VMEs was obtained using gradient strips (14.8%), especially with vancomycin, teicoplanin and daptomycin; (c) 86.4% of the centers identified VanA and VanB phenotypes correctly, and 95.0% the VanC phenotype. CONCLUSION: Most Spanish microbiology laboratories can reliably determine AS in VRE, but there is a significant percentage of inadequate interpretations (warning of false susceptibility) for teicoplanin in isolates with the VanB phenotype.

Machine-learning models for prediction of sepsis patients mortality.

OBJECTIVES: Sepsis is an infection-caused syndrome, that leads to life-threatening organ damage. We aim to develop machine learning models with large-scale data to predict sepsis patients' mortality. DESIGN: we extracted sepsis patients from two databases, Medical Information Mart for Intensive Care IV (MIMIC-IV) as a train set and Philips eICU Collaborative Research Database as a test set. SETTING: ICUs in multicenter hospitals in the USA during 2012-2019. PATIENTS OR PARTICIPANTS: A total of 21,680 sepsis-3 patients are included in the study, in which, 3771 patients were dead and 17,909 survived during hospitalization, respectively. INTERVENTIONS: No interventions. MAIN VARIABLES OF INTEREST: Basic information, examination items during hospitalization and some medication and treatment information are incorporated into analyzed. Seven different models were built with a Support vector machine, Decision Tree Classifier, Random Forest, Gradients Boosting, Multiple Layer Perception, Xgboost, light Gradients Boosting to predict dead or live during hospitalization. RESULTS: Algorithms with an AUC value in the test set of the top three: light GBM, GBM, Xgboost. Considering the performance of the training set and the test set, the light GBM model performs best, and then the parameters of the model were adjusted, after that the AUC value was 0.99 in the train set, 0.96 in the test set, respectively. CONCLUSIONS: Models built with light GBM algorithm from real-world sepsis patients from electronic health records accurately predict whether sepsis patients are dead and can be incorporated into clinical decision tools to enhance the prognosis of the patient and prevent adverse outcomes.

[Synchronic multicentric osteosarcoma. A case in a 10 year old boy and review of the literature]. / Osteosarcoma multicéntrico sincrónico. Un caso en niño de 10 años y revisión de la literatura.

The osteosarcoma is a malignant neoplasm originating in bone-producing cells whose usual presentation is predominantly monostotic in long bones. The polyostotic expression is rare, variable and controversial, predominantly high-grade cellular lesions in children; low-grade lesions that affect long bones in adults and others that show a dominant lesion in long bones from which metastases arise. We present the case of a ten-year-old patient with painful tumors in metaphasis and diaphysis of the femur, tibia, fibula, clavicle, humerus, as well as in pelvis, vertebrae and base of the skull of synchronous appearance with blindness. Diagnosis was made through X-ray images, CT scan, magnetic resonance imaging (MRI), and incisional biopsy of the femur. Evidenced of absence of neoplastic manifestation in lung imaging, at the time of pathological diagnosis. Histological findings revealed a high-grade osteosarcoma.

Cardiac amyloidosis: Description of a series of 143 cases. / Amiloidosis cardiaca: descripción de una serie de 143 casos.

INTRODUCTION AND OBJECTIVES: Recently, there have been important advances in the diagnosis and treatment of cardiac amyloidosis (CA). Our aim was to provide an updated description of its 2 most frequent types: the transthyretin CA (ATTR-CA) and the light chain CA (AL-CA). METHODS: Prospective registry of patients with CA diagnosed in 7 institutions in Galicia (Spain) between January 1, 2018 and June 30, 2020. Variables related to clinical characteristics, complementary tests, survival and causes of death were collected. RESULTS: One hundred and forty-three patients with CA were consecutively included, 128 ATTR-CA (89.5%) and 15 AL-CA (10.5%). Mean age was 79.6±7.7 years and 23.8% were women. Most patients with ATTR-CA were diagnosed non-invasively (87.5%). On physical examination, 35.7, 35 and 7% had Popeye's sign, Dupuytren's contracture and macroglossia, respectively. Twelve-month and 24-month survival was 92.1 and 76.2% in the ATTR-CA group, and 78.6 and 61.1% in the AL-CA group (P=.152). The cause of death was cardiovascular in 80.8% of the cohort. CONCLUSIONS: ATTR-CA can be diagnosed non-invasively in most cases and it is the most common type of CA in routine clinical practice. Furthermore, an increase in the short-term survival of CA appears to be observed, which could be due to advances related to its diagnosis and treatment.

Processing of osteoarticular samples for microbiological diagnosis: Results of a national multi-center survey.

INTRODUCTION: Our aim was to evaluate the variability in the processing of osteoarticular samples for microbiological diagnosis between different national centers. METHODS: An online survey with 13 questions was designed and it was sent through SEIMC to the Microbiology Departments of the different centers. RESULTS: We obtained 72 answers. In more than half of the tertiary-care centers, at least 5 samples are received. Approximately half of the centers vortex bones/implant samples. Sonication is used mostly in tertiary-care centers. Cultures for aerobic and anaerobic bacteria are performed during 6-10 days of incubation but with differences in liquid culture media. Molecular diagnosis is performed in less than 50% of the centers. Universal PCR (16S rRNA) is the most widely used technique. CONCLUSION: We found heterogeneity especially in the use of sonication, liquid culture media or molecular diagnosis, probably in direct relation to the resources and capacities of each center.

The use of mechanical restraint in critical care units: Characterisation, application standards and related factors. Results of a multicentre study.

OBJECTIVES: To describe and characterise the use of mechanical restraint (MR) in critical care units (CCU) in terms of frequency and quality of application and to study its relationship with pain/agitation-sedation/delirium, nurse:patient ratio and institutional involvement. METHOD: Multicentre observational study conducted in 17 CCUs between February and May 2016. The observation time per CCU was 96 h. The main variables were the prevalence of restraint, the degree of adherence to MR recommendations, pain/agitation-sedation/delirium monitoring and institutional involvement (protocols and training of professionals). RESULTS: A total of 1070 patients were included. The overall prevalence of restraint was 19.11%, in patients with endotracheal tube (ETT) 42.10% and in patients without ETT or artificial airway it was 13.92%. Adherence rates between 0% and 40% were obtained for recommendations related to non-pharmacological management and between 0% and 100% for those related to monitoring of ethical-legal aspects. The lower prevalence of restraint was correlated with adequate pain monitoring in non-communicative patients (P < .001) and with the provision of training for professionals (P = .020). An inverse correlation was found between the quality of the use of MR and its prevalence, both in the general group of patients admitted to CCU (r = -.431) and in the subgroup of patients with ETT (r = -.521). CONCLUSIONS: Restraint is especially frequently used in patients with ETT/artificial airway, but is also used in other patients who may not meet the use profile. There is wide room for improvement in non-pharmacological alternatives to the use of MC, ethical and legal vigilance, and institutional involvement. Better interpretation of patient behaviour with validated tools may help limit use of MR.

Processing of osteoarticular samples for microbiological diagnosis: Results of a national multi-center survey. / Procesamiento de muestras osteoarticulares para diagnóstico microbiológico: resultados de una encuesta multicéntrica nacional.

INTRODUCTION: Our aim was to evaluate the variability in the processing of osteoarticular samples for microbiological diagnosis between different national centers. METHODS: An online survey with 13 questions was designed and it was sent through SEIMC to the Microbiology Departments of the different centers. RESULTS: We obtained 72 answers. In more than half of the tertiary-care centers, at least 5 samples are received. Approximately half of the centers vortex bones/implant samples. Sonication is used mostly in tertiary-care centers. Cultures for aerobic and anaerobic bacteria are performed during 6-10 days of incubation but with differences in liquid culture media. Molecular diagnosis is performed in less than 50% of the centers. Universal PCR (16S rRNA) is the most widely used technique. CONCLUSION: We found heterogeneity especially in the use of sonication, liquid culture media or molecular diagnosis, probably in direct relation to the resources and capacities of each center.

A multicenter and observational study of the Ambu™ AuraGain™ laryngeal mask in adult patients. / Estudio multicéntrico observacional de la mascarilla Ambu® AuraGain® en pacientes adultos.

PURPOSE: The main objective of this study was to evaluate the performance of the Ambu™ AuraGain™ device by determining its main parameters of use and complications. METHODS: A total of 250 adult ASA physical status i to iii patients from five hospitals in Spain who received general anaesthesia with a supraglottic airway (SGA) device were enrolled in this study. RESULTS: The primary outcome was analysed for 244 patients and a median OLP of 32 cm H2O (IQR 28-36 cm H2O) was obtained. Insertion was achieved at first attempt in 85% of cases, and overall in 98% of cases, in a median time of 15 s (12-22.5). We applied manoeuvres in 61% of patients to facilitate the process. Ventilation was effective in 97.2% of the interventions (95% CI 0.99-0.94) throughout the procedure. Insertion of the gastric tube was easily performed in 99.6% of the patients, and the vocal cords were viewed by fibrobronchoscopy in 96.3% of cases. Logistic regression analysis identified the use of sizes smaller than those recommended as a risk factor for low OLP (< 25 cm H2O). The main complication recorded was the presence of blood when withdrawing the SGA device (15%). CONCLUSIONS: Our results confirm that the use of AuraGain allows airway management in a reliable and effective way achieving high OLP and low incidence of associated complications, establishing it as a useful alternative in the routine clinical setting of anaesthesiologists. AuraGain performance was consistent in all five centres.

Spanish Video-Assisted Thoracic Surgery Group: Method, Auditing, and Initial Results From a National Prospective Cohort of Patients Receiving Anatomical Lung Resections.

INTRODUCTION: Our study sought to know the current implementation of video-assisted thoracoscopic surgery (VATS) for anatomical lung resections in Spain. We present our initial results and describe the auditing systems developed by the Spanish VATS Group (GEVATS). METHODS: We conducted a prospective multicentre cohort study that included patients receiving anatomical lung resections between 12/20/2016 and 03/20/2018. The main quality controls consisted of determining the recruitment rate of each centre and the accuracy of the perioperative data collected based on six key variables. The implications of a low recruitment rate were analysed for "90-day mortality" and "Grade IIIb-V complications". RESULTS: The series was composed of 3533 cases (1917 VATS; 54.3%) across 33 departments. The centres' median recruitment rate was 99% (25-75th:76-100%), with an overall recruitment rate of 83% and a data accuracy of 98%. We were unable to demonstrate a significant association between the recruitment rate and the risk of morbidity/mortality, but a trend was found in the unadjusted analysis for those centres with recruitment rates lower than 80% (centres with 95-100% rates as reference): grade IIIb-V OR=0.61 (p=0.081), 90-day mortality OR=0.46 (p=0.051). CONCLUSIONS: More than half of the anatomical lung resections in Spain are performed via VATS. According to our results, the centre's recruitment rate and its potential implications due to selection bias, should deserve further attention by the main voluntary multicentre studies of our speciality. The high representativeness as well as the reliability of the GEVATS data constitute a fundamental point of departure for this nationwide cohort.

Is p-Phenylenediamine Still a Prevalent Contact Allergen in Spain? / ¿Sigue siendo la parafenilendiamina un alérgeno de contacto prevalente en España?

OBJECTIVES: To analyze trends in the prevalence of contact sensitization to p-phenylenediamine between 2004 and 2014, taking into consideration that the concentration of this product in cosmetics was regulated in 2009. To explore risk factors for contact allergy to p-phenylenediamine. MATERIAL AND METHODS: Retrospective observational study of patients suspected of having contact dermatitis from allergy to p-phenylenediamine during the years between 2004 and 2015 in 8 tertiary level hospitals. The patients underwent patch testing (TRUE-test) with the standard series of the Spanish Research Group on Contact Dermatitis and Skin Allergies. This series included p-phenylenediamine 1%. We followed international recommendations for the statistical analysis of data related to contact allergies. RESULTS: Three hundred eighty-six out of 9341 patients (4.1%) had positive reactions to p-phenylenediamine. The prevalence tended to decrease in the early years (2004-2007) and then leveled off at around 4%. Risk factors for developing contact dermatitis from p-phenylenediamine were sex, age over 40 years, multiple sensitivities, and profession, notably workers in hair salons and those who handle rubber and plastics. CONCLUSIONS: The prevalence of p-phenylenediamine allergy remains high among patients with contact eczema. Risk factors for p-phenylenediamine contact allergy are consistent with previous reports.

Call to participate in the international study of traumatic brain injury results (Global Neurotrauma Outcomes Study). / Llamada para participar en el estudio internacional de resultados del traumatismo craneoencefálico (Global Neurotrauma Outcomes Study).

Traumatic brain injury (TBI) accounts for a significant amount of death and disability worldwide and the majority of this burden affects individuals in low-and-middle income countries. The GNOS is a multi-centre international, prospective cohort study. This study is the first global neurosurgical study that aims to provide a comprehensive picture of the management and outcomes of patients undergoing emergency surgery for TBI worldwide.

Bodies of desire: use of nonprescribed hormones among transgender women and travestis in five brazilian capitals (2019–2021) / Corpos do desejo: uso de hormônios sem prescrição médica entre mulheres trans e travestis em cinco capitais brasileiras (2019–2021)

Objective: To analyze the experiences of transgender women and travestis regarding the use of hormones for body changes without a medical prescription. Methods: This is a cross-sectional, quantitative and qualitative study, using data from “TransOdara”, which estimated the prevalence of Sexually Transmitted Infections in transgender women and travestis recruited through Respondent-Driven Sampling, between December 2019 and July 2021, in São Paulo, Campo Grande, Manaus, Porto Alegre, and Salvador, Brazil. The main outcome was: use of hormones without medical prescription and associated risk factors. Descriptive analysis, mixed univariate logistic regression models, and semi-structured interviews were carried out. Results: Of the 1,317 recruited participants, 85.9% had already used hormones. The current use of hormones was reported by 40.7% (536) of them. Of those who were able to inform the place where they obtained them, 72.6% (381/525) used them without a medical prescription. The variables associated with the outcome were: current full-time sex work (OR 4.59; 95%CI 1.90–11.06) or in the past (OR 1.92; 95%CI 1.10–3.34), not having changed their name (OR 3.59; 95%CI 2.23–5.76), not currently studying (OR 1.83; 95%CI 1.07–3.13), being younger (OR 2.16; 95%CI 1.31–3.56), and having suffered discrimination at some point in life for being a transgender women and travestis (OR 0.40; 95%CI 0.20–0.81). Conclusion: The use of nonprescribed hormones is high among transgender women and travestis, especially among those who are younger, did not study, have not changed their name, and with a history of sex work. This use is related to the urgency for gender transition, with excessive use and damage to health.

Objetivo: Analisar experiências de mulheres trans e travestis com o uso de hormônios para mudança corporal sem prescrição médica. Métodos: Estudo de corte transversal, quantitativo e qualitativo, utilizando um recorte do TransOdara, que estimou prevalência de Infecções Sexualmente Transmissíveis em mulheres trans e travestis, recrutadas por meio de Respondent-Driven Sampling, entre dezembro de 2019 e julho de 2021, em São Paulo, Campo Grande, Manaus, Porto Alegre e Salvador. Principal desfecho: uso de hormônios sem prescrição médica e fatores associados. Foram realizados análise descritiva e modelos de regressão logísticos univariados mistos e entrevistas semiestruturadas. Resultados: Das 1.317 participantes recrutadas, 85,9% já haviam usado hormônios. O uso atual de hormônios foi referido por 40,7% (536) delas. Das que souberam informar o local onde os conseguiram, 72,6% (381/525) faziam uso sem prescrição médica. As variáveis associadas ao uso sem prescrição foram: exercer trabalho sexual em tempo integral (OR 4,59; IC95% 1,90–11,06) ou no passado (OR 1,92; IC95% 1,10–3,34); não ter retificado o nome (OR 3,59; IC95% 2,23–5,76); não estar estudando (OR 1,83; IC95% 1,07–3,13); ser mais jovem (OR 2,16; IC95% 1,31–3,56); ter sofrido discriminação em algum momento na vida por ser mulheres trans e travestis (OR 0,40 – IC95% 0,20–0,81). Conclusão: O uso de hormônios não prescritos é alto entre mulheres trans e travestis, principalmente entre as mais jovens, as que não estudavam, as que não retificaram o nome e as com histórico de trabalho sexual. Está relacionado à urgência para a transição de gênero, com uso exagerado e danos à saúde.

Bodies of desire: use of nonprescribed hormones among transgender women and travestis in five Brazilian capitals (2019-2021) / Corpos do desejo: uso de hormônios sem prescrição médica entre mulheres trans e travestis em cinco capitais brasileiras (2019-2021)

ABSTRACT Objective: To analyze the experiences of transgender women and travestis regarding the use of hormones for body changes without a medical prescription. Methods: This is a cross-sectional, quantitative and qualitative study, using data from "TransOdara", which estimated the prevalence of Sexually Transmitted Infections in transgender women and travestis recruited through Respondent-Driven Sampling, between December 2019 and July 2021, in São Paulo, Campo Grande, Manaus, Porto Alegre, and Salvador, Brazil. The main outcome was: use of hormones without medical prescription and associated risk factors. Descriptive analysis, mixed univariate logistic regression models, and semi-structured interviews were carried out. Results: Of the 1,317 recruited participants, 85.9% had already used hormones. The current use of hormones was reported by 40.7% (536) of them. Of those who were able to inform the place where they obtained them, 72.6% (381/525) used them without a medical prescription. The variables associated with the outcome were: current full-time sex work (OR 4.59; 95%CI 1.90-11.06) or in the past (OR 1.92; 95%CI 1.10-3.34), not having changed their name (OR 3.59; 95%CI 2.23-5.76), not currently studying (OR 1.83; 95%CI 1.07-3.13), being younger (OR 2.16; 95%CI 1.31-3.56), and having suffered discrimination at some point in life for being a transgender women and travestis (OR 0.40; 95%CI 0.20-0.81). Conclusion: The use of nonprescribed hormones is high among transgender women and travestis, especially among those who are younger, did not study, have not changed their name, and with a history of sex work. This use is related to the urgency for gender transition, with excessive use and damage to health.

RESUMO Objective Analisar experiências de mulheres trans e travestis com o uso de hormônios para mudança corporal sem prescrição médica. Métodos: Estudo de corte transversal, quantitativo e qualitativo, utilizando um recorte do TransOdara, que estimou prevalência de Infecções Sexualmente Transmissíveis em mulheres trans e travestis, recrutadas por meio de Respondent-Driven Sampling, entre dezembro de 2019 e julho de 2021, em São Paulo, Campo Grande, Manaus, Porto Alegre e Salvador. Principal desfecho: uso de hormônios sem prescrição médica e fatores associados. Foram realizados análise descritiva e modelos de regressão logísticos univariados mistos e entrevistas semiestruturadas. Resultados: Das 1.317 participantes recrutadas, 85,9% já haviam usado hormônios. O uso atual de hormônios foi referido por 40,7% (536) delas. Das que souberam informar o local onde os conseguiram, 72,6% (381/525) faziam uso sem prescrição médica. As variáveis associadas ao uso sem prescrição foram: exercer trabalho sexual em tempo integral (OR 4,59; IC95% 1,90-11,06) ou no passado (OR 1,92; IC95% 1,10-3,34); não ter retificado o nome (OR 3,59; IC95% 2,23-5,76); não estar estudando (OR 1,83; IC95% 1,07-3,13); ser mais jovem (OR 2,16; IC95% 1,31-3,56); ter sofrido discriminação em algum momento na vida por ser mulheres trans e travestis (OR 0,40 - IC95% 0,20-0,81). Conclusão: O uso de hormônios não prescritos é alto entre mulheres trans e travestis, principalmente entre as mais jovens, as que não estudavam, as que não retificaram o nome e as com histórico de trabalho sexual. Está relacionado à urgência para a transição de gênero, com uso exagerado e danos à saúde.