RESUMEN

Antecedentes: Los ensayos quirúrgicos aleatorizados controlados (EQAC) son la mejor manera de validar los nuevos tratamientos quirúrgicos; sin embargo, comprenden una fracción muy pequeña de los artículos publicados en la literatura. Una de las razones de la falta de éxito es el hecho de no reclutar un número adecuado de pacientes. Métodos: Se presentan los resultados de 14 meses de reclutamiento de un EQAC que compara dos procedimientos quirúrgicos para el tratamiento del hallux valgus doloroso. El estudio es no ciego, de no inferioridad y paralelo con una meta de inclusión de 100 sujetos en 24 meses. Resultados: En los primeros 14 meses de reclutamiento, 94 pacientes fueron evaluados para su elegibilidad, de los cuales 54 fueron excluidos y 40 cumplían con criterios según protocolo. De estos 40, 13 fueron incluidos en el proceso de aleatorización pero sólo 11 fueron sometidos a los procedimientos quirúrgicos, ya que dos se rehusaron a dicho proceso el día de la cirugía. De los 27 pacientes elegibles restantes, en 22 no hubo más contacto después de completar la evaluación de elegibilidad y siete se negaron al procedimiento aleatorio. Los resultados indican que el estudio no recluta un número suficiente de sujetos. Conclusiones: Los datos muestran que los investigadores que planean realizar un EQAC deben ser conscientes de la gran cantidad de esfuerzo y recursos financieros necesarios para alcanzar las metas de reclutamiento de pacientes.

Background: Randomized controlled surgical trials (RCST) are the optimal way to validate new surgical treatments, yet RCSTs comprise a very small fraction of published articles in the surgical literature. One of most frequent reasons for lack of success in RCSTs is the failure to recruit an adequate number of patients. Methods: We report the results of 14 months of recruitment for an RCST comparing two different surgical procedures for the treatment of painful hallux valgus. The study is an open-label non-inferiority parallel trial, with an accrual goal of 100 subjects in 24 months. Results: In the first 14 months of recruitment, 94 patients were assessed for eligibility, of which 54 were excluded and 40 were protocol-eligible. Of these 40 only 13 enrolled in the trial. Eleven patients were randomized and treated according to the protocol, the other two withdrew prior to randomization. Of the 27 eligible patients who did not enroll and the 2 eligible patients who withdrew prior to ramdomization, 22 declined to participate in the study and 7 elected to have surgical treatment but refused randomization. Conclusions: The data show that investigators planning RCST's in surgery should be aware of the large amount of effort and significant financial resources needed to achieve patient recruitment goals.

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RESUMEN

BACKGROUND: Randomized controlled surgical trials (RCST) are the optimal way to validate new surgical treatments, yet RCSTs comprise a very small fraction of published articles in the surgical literature. One of most frequent reasons for lack of success in RCSTs is the failure to recruit an adequate number of patients. METHODS: We report the results of 14 months of recruitment for an RCST comparing two different surgical procedures for the treatment of painful hallux valgus. The study is an open-label non-inferiority parallel trial, with an accrual goal of 100 subjects in 24 months. RESULTS: In the first 14 months of recruitment, 94 patients were assessed for eligibility, of which 54 were excluded and 40 were protocol-eligible. Of these 40 only 13 enrolled in the trial. Eleven patients were randomized and treated according to the protocol, the other two withdrew prior to randomization. Of the 27 eligible patients who did not enroll and the 2 eligible patients who withdrew prior to ramdomization, 22 declined to participate in the study and 7 elected to have surgical treatment but refused randomization. CONCLUSIONS: The data show that investigators planning RCST's in surgery should be aware of the large amount of effort and significant financial resources needed to achieve patient recruitment goals.

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