A randomized controlled noninferiority trial comparing radiofrequency with stripping and conservative hemodynamic cure for venous insufficiency technique for insufficiency of the great saphenous vein.

OBJECTIVE: The quality of available evidence regarding new minimally invasive techniques to abolish great saphenous vein reflux is moderate. The present study assessed whether radiofrequency ablation (RFA) was noninferior to high ligation and stripping (HLS) and conservative hemodynamic cure for venous insufficiency (CHIVA) for clinical and ultrasound recurrence at 2 years in patients with primary varicose veins (VVs) due to great saphenous vein (GSV) insufficiency. METHODS: We performed a randomized, single-center, open-label, controlled, noninferiority trial to compare RFA and 2 surgical techniques for the treatment of primary VVs due to GSV insufficiency. The noninferiority margin was set at 15% for absolute differences. Patients aged >18 years with primary VVs and GSV incompetence, with or without clinical symptoms, C2 to C6 CEAP (Clinical, Etiologic, Anatomic, Pathophysiologic) clinical class, and GSV diameter >4 mm were randomized with a 1:1:1 ratio to RFA, HLS, or CHIVA. The rate of clinical recurrence at 24 months was the primary endpoint and was analyzed using a delta noninferiority margin of 15%. Ultrasound recurrence, safety, and quality of life were secondary endpoints. RESULTS: From December 2012 to June 2015, 225 limbs had been randomized to RFA, HLS, or CHIVA (n = 74, n = 75, and n = 76). Clinical follow-up and Doppler ultrasound examinations were performed at 1 week and 1, 6, 12, and 24 months postoperatively. No differences in postoperative complications or pain were observed among the three groups. RFA was noninferior to HLS and CHIVA for clinical recurrence at 24 months, with an estimated difference in recurrence of 3% (95% confidence interval [CI], -4.8% to 10.7%; noninferiority P = .002) and -7% (95% CI, -17% to 3%; P < .001), respectively. For ultrasound recurrence, RFA was noninferior to CHIVA, with an estimated difference of -34% (95% CI, -47% to -20%; noninferiority P < .001) at 24 months. However, noninferiority could not be demonstrated compared with HLS (5.9%; 95% CI, -4.1 to 15.9; P = .073). No differences were found in quality of life among the three groups. CONCLUSIONS: RFA was shown to be noninferior in terms of clinical recurrence to HLS and CHIVA in the treatment of VVs due to GSV insufficiency.

Avanzando en la toma de decisiones compartida: estenosis carotídea asintomática / Advancing in shared decision making: asymptomatic carotid stenosis

En las últimas décadas ha venido produciéndose un cambio de paradigma en la relación médico-enfermo, que ha pasado de una visión paternalista a una medicina más centrada en el paciente. La toma de decisiones compartidas (TDC) es un proceso que incluye el intercambio de información (personal y médica) entre el paciente y el sanitario respecto a la enfermedad, la deliberación sobre las distintas opciones y, finalmente, la toma de una decisión consensuada. Para facilitar este proceso se han desarrollado distintas herramientas mediante diversos medios y formatos (folletos, texto escrito, vídeos, aplicaciones informáticas...), utilizando en muchas ocasiones ayudas visuales tales como caras sonrientes u otros pictogramas. Desde nuestro grupo de trabajo nos unimos a este proceso evolutivo de la práctica médica y presentamos una herramienta de ayuda visual a la TDC en el caso de pacientes con estenosis carotídea asintomática mayor del 70%. Para su realización nos hemos basado en los cates plots, que ayudan a cuantificar riesgos y beneficios de una intervención de forma estandarizada

In the last decades there has been a paradigm change in the doctor-patient relationship, from a paternalistic model to a patient centered medicine. Shared decision making (SDM) is a process that involves bidirectional communication between physicians and patients about the illness, different treatment options, and, through the deliberation process, reaching an agreement in the ultimate decision made. Various different tools have been developed to promote shared decision making, through different types of support methods (leaflets, books, videos, websites or other interactive media), frequently using visual aids like smiley faces plots or other pictograms. Our Working Group would like to join this evolutionary process. Thus, we have developed a visual aid tool to help in the decision-making process in the case of asymptomatic carotid stenosis > 70%. We have based on Cates plots that help to quantify risks and benefits of specific interventions in a standardized manner

Study to develop a waiting list prioritization score for varicose vein surgery.

BACKGROUND: The objective of this study was to develop a clear-cut, objective system for prioritization of patients on the waiting list for varicose vein surgery, to enable organization of access to the health service. METHODS: During earlier phases, we selected which variables should be taken into account for the prioritization scale, such as clinical presentation, varicose vein size, complications, work situation, and influence on quality of life. In the last phase, to determine the relative weight of each variable, structured surveys (personal interviews or by e-mail) were performed of the convenience samples from the groups related to the healthcare process, including patients, relatives, and healthcare professionals. RESULTS: The structured survey we utilized was administered to a sample of 762 subjects that included 290 patients, 99 relatives, 179 general practitioners, 32 nurses, and 162 vascular surgeons. The final score included clinical manifestations (46.1% of relative importance), size of the varicose veins (8.2%), complications (18.3%), influence on quality of life (18.2%), and aggravating work factors (9.2%). CONCLUSIONS: The prioritization system agreed upon by all the groups involved could allow for objective and transparent prioritization and lead to the rationalization of access to varicose vein surgery for patients on the waiting list.