Medical student knowledge of global health problems: obstetric fistulas in developing countries.

OBJECTIVE: To evaluate medical students in the United States at several medical schools regarding their knowledge of the global health burden of obstetric fistulas. STUDY DESIGN: A cross-sectional survey was conducted in 8 schools across the United States over a period of 6 months. The survey was composed of 18 questions on epidemiology, pathology, and treatment of fistulas. It was a web-based module accessed through an emailed link. It was sent to 5,103 medical students\u27 email addresses at the 8 institutions once a week for 4 weeks. SPSS paired student t tests was used for statistical analysis. RESULTS: Of the 1,089 students from 8 medical schools that initially began the survey, 965 completed this voluntary and anonymous survey, with a 21% response rate and 19% completion rate. Overall the students averaged 11/18 (60.7%) correct on this survey. The knowledge of obstetric fistula improved, but not significantly, with increasing level of medical school education, with first-year medical students achieving 10/18 (55%) correct and senior medical students achieving 12/18 (67%) correct (p = 0.1). CONCLUSION: U.S. medical students\u27 knowledge of obstetric fistulas in developing countries does not increase significantly over 4 years of medical school education. While this condition presents largely in the developing world, given rapid globalization as well as increased international health experiences for U.S.-trained health professionals,further effort should be placed in improving medical student knowledge of this devastating condition

Efficacy and Safety of a Nonanimal Stabilized Hyaluronic Acid/Dextranomer in Improving Fecal Incontinence: A Prospective, Single-Arm, Multicenter, Clinical Study With 36-Month Follow-up

BackgroundFecal incontinence affects 7% to 12% of the US adult population, causing social, financial, and quality of life burdens.ObjectiveThe primary aim of this study was to evaluate the efficacy and safety of nonanimal stabilized hyaluronic acid/dextranomer through 36 months as a condition of postmarket approval application.DesignThis was a prospective, single-arm, multicenter, observational Food and Drug Administration-mandated postapproval clinical study.SettingsThis study was designed and executed by participating centers in 18 hospitals and colorectal health clinics in coordination with the Food and Drug Administration and the study sponsor.PatientsA total of 283 subjects who previously failed conservative therapy were enrolled across 18 US sites.InterventionsParticipants received 1 to 2 nonanimal stabilized hyaluronic acid/dextranomer treatments. The first treatment occurred within 30 days of baseline, and a second treatment was administered 1 to 3 months after initial treatment if determined necessary by the physician. Subjects were followed through 7 visits over 36 months after last treatment.Main outcome measuresEfficacy (as specified by the Food and Drug Administration) was measured as a fecal incontinence reintervention rate of <50% at 36 months. Reintervention included nonanimal stabilized hyaluronic acid/dextranomer re-treatment, surgical interventions, and physical therapy. Safety was measured by device-related adverse events. Secondary end points included Fecal Incontinence Quality of Life Scale and Cleveland Clinic Florida Fecal Incontinence Score.ResultsUsing a Bayesian estimate, the reintervention rate of the intention-to-treat population (n = 283) was 18.9% (95% CI, 14.0-24.4) at 36 months. At 36 months, the reintervention rate for subjects with complete data (n = 192) was 20.8% (95% CI, 15.1-26.6). Significant improvement ( p < 0.0001) was noted across the Cleveland Clinic Florida Fecal Incontinence Score and Fecal Incontinence Quality of Life subscales at 36 months. Ninety-two device-related adverse events were reported by 15.2% of enrolled patients; most were GI disorders and resolved quickly. There were no serious adverse events.LimitationsLimitations of the study included a 32% attrition rate and homogeneous patient population (91.8% white; 85.5% female), possibly limiting generalizability.ConclusionsNonanimal stabilized hyaluronic acid/dextranomer demonstrated clinically significant, sustained improvement in symptoms and quality of life for fecal incontinence patients without the occurrence of any serious adverse events. See Video Abstract at http://links.lww.com/DCR/B890 .RegistrationClinicalTrials.gov ; Unique identifier: NCT01647906.Eficacia y seguridad de un cido hialurnico/ dextranmero estabilizado de orgen no animal para mejorar la incontinencia fecal un estudio clnico prospectivo, multicntrico y de un solo brazo con seguimiento de mesesANTECEDENTES:La incontinencia fecal afecta entre el 7 y el 12% de la población adulta de los EE. UU. Y genera cargas sociales, económicas y de calidad de vida.OBJETIVO:Los objetivos principales de este estudio fueron evaluar la eficacia y seguridad del ácido hialurónico/ dextranómero estabilizado de origen no animal durante 36 meses como condición para la solicitud de aprobación posterior a la comercialización.DISEÑO:Este fue un estudio clínico prospectivo, observacional, de un solo brazo, multicéntrico, ordenado por la FDA después de la aprobación.AJUSTES:Este estudio fue diseñado por los investigadores participantes, la FDA y el patrocinador del estudio que gestionó la recopilación de datos.PACIENTES:Un total de 283 sujetos en quienes previamente falló la terapia conservadora se inscribieron en el estudio prospectivo de un solo brazo en 18 sedes de EE. UU. (NCT01647906).INTERVENCIONES:Los participantes recibieron 1-2 tratamientos con ácido hialurónico/ dextranómero estabilizado no animal. El primer tratamiento se dio dentro de los 30 días posteriores al inicio, mientras que un segundo tratamiento se administró 1-3 meses después del tratamiento inicial si el médico lo determinaba necesario. Los sujetos fueron seguidos durante 7 visitas durante 36 meses después del último tratamiento.PRINCIPALES MEDIDAS DE RESULTADO:La eficacia (según especificado por la FDA) se midió como una tasa de reintervención de incontinencia fecal de <50% a los 36 meses. La reintervención incluyó retratamiento con ácido hialurónico/ dextranómero estabilizado no animal, intervenciones quirúrgicas y fisioterapia. La seguridad se midió mediante los eventos adversos relacionados con tratamiento. Los criterios de valoración secundarios incluyeron la escala de calidad de vida de incontinencia fecal y la puntuación de incontinencia fecal de Cleveland Clinic Florida.RESULTADOS:Utilizando una estimación bayesiana, la tasa de reintervención de la población por intención de tratar (n = 283) fue del 18.9% (IC del 95%: 14.0%, 24.4%) a los 36 meses. A los 36 meses, la tasa de reintervención para los sujetos con datos completos (n = 192) fue del 20.8% (IC del 95%: 15.1%, 26.6%). Se observó una mejora significativa (p <0.0001) en las subescalas de la puntuación de incontinencia fecal de la Cleveland Clinic Florida y de la calidad de vida de la incontinencia fecal a los 36 meses. El 15.2% de los pacientes inscritos informaron 92 eventos adversos relacionados con el tratmiento; la mayoría eran trastornos gastrointestinales y se resolvieron rápidamente. No hubo eventos adversos graves.LIMITACIONES:Las limitaciones incluyen una tasa de deserción del 32% y una población de pacientes homogénea (91.8% blancos, 85.5% mujeres), lo que posiblemente limite la generalización.CONCLUSIÓNES:El ácido hialurónico/ dextranómero estabilizado de origen no animal demostró una mejora sostenida y clínicamente significativa de los síntomas y la calidad de vida de los pacientes con incontinencia fecal, sin que se produjeran efectos adversos graves. Consulte el Video Resumen en http://links.lww.com/DCR/B890 . ( Traducción-Dr. Jorge Silva Velazco )Registro: ClinicalTrials.gov número NCT01647906