Urolitiasis en Atención Primaria: comparación de un seguimiento sistemático frente a la práctica habitual / Urolithiasis in Primary Care: Comparison of a systematic follow-up versus usual clinical practice

Objetivo: La implantación de acciones clínicas preventivas en Atención Primaria permitiría actuar sobre la alta incidencia de urolitiasis y sus factores de riesgo corregibles. Este estudio piloto comparó un seguimiento sistemático (SS) frente al seguimiento habitual (SH) en términos de viabilidad, seguridad y eficacia clínica. Materiales y métodos: Realizamos un estudio piloto multicéntrico y controlado en 30 pacientes, comparando el SS y el SH. Los pacientes fueron aleatorizados según una lista generada por ordenador. Se definió el «éxito del estudio» como la consecución de los objetivos de viabilidad: tasa de reclutamiento, adherencia, finalización del seguimiento y recursos humanos necesarios. Se recogieron variables clínicas (dolor y fiebre), analíticas (sangre y orina) y de imagen (ecografía y radiografía) a los 10, 45 y 90 días en el grupo de SS y a los 3 meses en el de SH. En el grupo de SS se entregaron recomendaciones dietéticas y analgésicas. Se hizo una comparación clínica preliminar y se registraron las complicaciones en cada grupo. Resultados: Los objetivos de viabilidad se consiguieron como sigue: 94,1% de tasa de reclutamiento, 5,9% de rechazo a la aleatorización, 10 pacientes reclutados al mes, adherencia del 93,1% y 90% de asistencia a la revisión final. Los resultados clínicos no favorecieron significativamente a ninguno de los dos grupos. En el grupo de SH hubo una recidiva. Conclusiones: Se cumplieron los objetivos de viabilidad estudiados excepto los relacionados con los recursos humanos. Los resultados clínicos no favorecieron a ningún grupo ni contraindicaron el desarrollo de un futuro ensayo clínico (AU)

Objective: The implementation of preventive clinical actions in Primary Care would allow to act on the high incidence of urolithiasis and the correctable risk factors. This pilot study compared a systematic follow-up (SFU) versus a regular follow-up (RFU) in terms of feasibility, safety and clinical outcomes. Materials and methods: We conducted a multicentric and controlled pilot study in 30 patients comparing SFU versus RFU. Patients followed allocation concealment by an independent blocked computer-generated list. We defined “success” if feasibility objectives were matched including recruitment rate, follow-up compliance, completion and staff resources. Clinic variables (pain and fever), analytics (blood and urine) and image techniques (echography and radiography) were recorded at 10, 45 and 90 days in SFU and at 3 months in RFU. The SFU group received nutritional and analgesic recommendations. Preliminary clinical outcomes were compared and complications were recorded in each group. Results: The feasibility objectives were matched as follows: 94.1% of recruitment rate, 5.9% refused to participate, 10 patients/month were recruited, 93.1% of follow-up compliance and 90% of completion. No clinical differences were found between groups. There was a recurrence in the RFU group. Conclusions: The feasibility objectives were matched except those related to human resources. Clinical outcomes did not favour any group or contraindicate the development of a future clinical trial (AU)

[Urolithiasis in Primary Care: Comparison of a systematic follow-up versus usual clinical practice]. / Urolitiasis en Atención Primaria: comparación de un seguimiento sistemático frente a la práctica habitual.

OBJECTIVE: The implementation of preventive clinical actions in Primary Care would allow to act on the high incidence of urolithiasis and the correctable risk factors. This pilot study compared a systematic follow-up (SFU) versus a regular follow-up (RFU) in terms of feasibility, safety and clinical outcomes. MATERIALS AND METHODS: We conducted a multicentric and controlled pilot study in 30 patients comparing SFU versus RFU. Patients followed allocation concealment by an independent blocked computer-generated list. We defined "success" if feasibility objectives were matched including recruitment rate, follow-up compliance, completion and staff resources. Clinic variables (pain and fever), analytics (blood and urine) and image techniques (echography and radiography) were recorded at 10, 45 and 90 days in SFU and at 3 months in RFU. The SFU group received nutritional and analgesic recommendations. Preliminary clinical outcomes were compared and complications were recorded in each group. RESULTS: The feasibility objectives were matched as follows: 94.1% of recruitment rate, 5.9% refused to participate, 10 patients/month were recruited, 93.1% of follow-up compliance and 90% of completion. No clinical differences were found between groups. There was a recurrence in the RFU group. CONCLUSIONS: The feasibility objectives were matched except those related to human resources. Clinical outcomes did not favour any group or contraindicate the development of a future clinical trial.