Screening uptake of colonoscopy versus fecal immunochemical testing in first-degree relatives of patients with non-syndromic colorectal cancer: A multicenter, open-label, parallel-group, randomized trial (ParCoFit study).

BACKGROUND: Colonoscopy screening is underused by first-degree relatives (FDRs) of patients with non-syndromic colorectal cancer (CRC) with screening completion rates below 50%. Studies conducted in FDR referred for screening suggest that fecal immunochemical testing (FIT) was not inferior to colonoscopy in terms of diagnostic yield and tumor staging, but screening uptake of FIT has not yet been tested in this population. In this study, we investigated whether the uptake of FIT screening is superior to the uptake of colonoscopy screening in the familial-risk population, with an equivalent effect on CRC detection. METHODS AND FINDINGS: This open-label, parallel-group, randomized trial was conducted in 12 Spanish centers between February 2016 and December 2021. Eligible individuals included asymptomatic FDR of index cases <60 years, siblings or ≥2 FDR with CRC. The primary outcome was to compare screening uptake between colonoscopy and FIT. The secondary outcome was to determine the efficacy of each strategy to detect advanced colorectal neoplasia (adenoma or serrated polyps ≥10 mm, polyps with tubulovillous architecture, high-grade dysplasia, and/or CRC). Screening-naïve FDR were randomized (1:1) to one-time colonoscopy versus annual FIT during 3 consecutive years followed by a work-up colonoscopy in the case of a positive test. Randomization was performed before signing the informed consent using computer-generated allocation algorithm based on stratified block randomization. Multivariable regression analysis was performed by intention-to-screen. On December 31, 2019, when 81% of the estimated sample size was reached, the trial was terminated prematurely after an interim analysis for futility. Study outcomes were further analyzed through 2-year follow-up. The main limitation of this study was the impossibility of collecting information on eligible individuals who declined to participate. A total of 1,790 FDR of 460 index cases were evaluated for inclusion, of whom 870 were assigned to undergo one-time colonoscopy (n = 431) or FIT (n = 439). Of them, 383 (44.0%) attended the appointment and signed the informed consent: 147/431 (34.1%) FDR received colonoscopy-based screening and 158/439 (35.9%) underwent FIT-based screening (odds ratio [OR] 1.08; 95% confidence intervals [CI] [0.82, 1.44], p = 0.564). The detection rate of advanced colorectal neoplasia was significantly higher in the colonoscopy group than in the FIT group (OR 3.64, 95% CI [1.55, 8.53], p = 0.003). Study outcomes did not change throughout follow-up. CONCLUSIONS: In this study, compared to colonoscopy, FIT screening did not improve screening uptake by individuals at high risk of CRC, resulting in less detection of advanced colorectal neoplasia. Further studies are needed to assess how screening uptake could be improved in this high-risk group, including by inclusion in population-based screening programs. TRIAL REGISTRATION: This trial was registered with ClinicalTrials.gov (NCT02567045).

Interdisciplinary recommendations document to improve adherence in patients with chronic inflammatory diseases: Adhing recommendations.

OBJECTIVE: Patient compliance in chronic inflammatory diseases is essential to achieve treatment effectiveness. The study objective is to develop a recommendations document for healthcare professionals to encourage treatment compliance. METHODS: A sequential methodology was followed: 1. Systematic review of EBM Reviews, Embase and MedLine without time restriction of interventions on compliance in chronic inflammatory diseases. Studies were selected according to previously defined criteria (confirmed diagnosis of chronic inflammatory disease of patients included, assessment of adherence interventions and experimental study design). 2. Three expert workshops (hospital pharmacy, nursing and medical specialties) to elaborate recommendations. 3. Expert online voting about the degree of agreement with recommendations. 4. Final face to face consensus workshop. RESULTS: A total of 1 115 papers were identified, 84 were fully reviewed and 30 were selected according to criteria. A preli minary list of 8 recommendations based on evidence was developed and discussed in the expert workshops. As a result, a new version of 14 recommendations was created. Later, online voting showed a high degree of agreement among experts: 7 out of 14 recommendations obtained unanimous approval; in the other 7, 1 to 3 experts were partially in disagreement. Recommendations without unanimous agreement were further reviewed and modified in the face to face meeting and final recommendations were approved unanimously. CONCLUSIONS: This consensus statement gathers all relevant aspects to be interdisciplinary considered to detect, monitor and assess medication adherence, involving the patient in the process. Further studies are needed to assess the impact of interventions to improve compliance in patients with chronic inflammatory diseases both in terms of adherence and in health outcomes.

Objetivo: La adherencia terapéutica en los pacientes con enfermedades inflamatorias crónicas es fundamental para alcanzar la efectividad del tratamiento. El objetivo de este trabajo es crear un documento de recomendaciones para los profesionales de la salud que promueva la adherencia al tratamiento. Métodos: Se siguió una metodología secuencial: 1. Revisión sistemática en Evidence Based Medicine Reviews (EBMR), Embase y MedLine de intervenciones en adherencia en enfermedades inflamatorias crónicas sin restriciones temporales. Los estudios se seleccionaron según criterios previamente definidos (pacientes diagnosticados de enfermedad inflamatoria crónica, evaluación de intervenciones para la mejora de la adherencia y diseño experimental de estudio). 2. Reunión con tres grupos de expertos (farmacia hospitalaria, enfermería y especialidades médicas) para generar recomendaciones. 3. Votación electrónica de los expertos sobre el grado de acuerdo con las recomendaciones. 4. Reunión presencial final de las recomendaciones. Resultados: Se identificaron 1.115 citas, se revisaron 84 y se seleccionaron 30 de acuerdo a los criterios de elegibilidad. Se redactó un listado inicial de 8 recomendaciones basadas en la evidencia, que se discutió en las reuniones de expertos y dio lugar a una nueva versión de 14 recomendaciones. La posterior votación electrónica de esta versión evidenció un elevado grado de acuerdo entre los expertos: en 7 recomendaciones, acuerdo unánime; en las 7 restantes, entre 1 y 3 expertos parcialmente en desacuerdo. En la reunión presencial se volvieron a revisar y modificar las recomendaciones, sin acuerdo unánime, que finalmente se aprobaron por unanimidad. Conclusiones: Estas recomendaciones recogen los aspectos relevantes para detectar, monitorizar y evaluar la adherencia terapéutica de forma multidisciplinar, implicando de forma activa al paciente. Son necesarios nuevos estudios para evaluar el impacto de las intervenciones para mejorar la adherencia en los pacientes con enfermedades inflamatorias crónicas y su influencia tanto en los aspectos relativos al cumplimiento como en los resultados en salud.

[Telematic consultations by nursing staff for patients with inflammatory bowel disease: evaluation of its capacity for resolving problems and its costs]. / Consulta telemática realizada por Enfermería en pacientes con enfermedad inflamatoria intestinal: valoración de su capacidad resolutiva y costes.

INTRODUCTION: The management of patients with inflammatory bowel disease (IBD) is associated with a significant use of healthcare resources. In 2009, a digestive diseases nursing consultation, with availability of health telematic media was created in our hospital (CHUVI). The important activity performed in this area encouraged us to quantify the cost savings for the care health system. AIMS: 1) To evaluate the results of the implementation of a telematic IBD consultation. 2) To assess the capacity for resolving problems by nurses. 3) To estimate the potential cost savings of telematic nursing consultation in IBD. MATERIAL AND METHOD: We collected data on telematic activity from 2009 to 2011. The estimated cost saving was calculated by applying the fees for health services published by our National Health Service (SERGAS) for care in new outbreaks of IBD activity. Data were analyzed with SPSS 15.0 RESULTS: There was a significant linear increase on the resolution of telephone demands by nurses (P=.03) and an important decrease of demands needing medical advice (P<.0001). Focusing on IBD outbreak claims (n=452), only 65 patients (14.38%) required medical attention in emergency services, and 33 (7.3%) were hospitalized. Altogether we calculated an average cost saving since 2009 to 2011 of 73,603€. CONCLUSIONS: We found a gradual increase in resolving telematic care demands by nurses. Telematic consultation can lead to significant cost savings, which justify the implementation of a digestive diseases nurse consultation.