Patient navigation for colorectal cancer screening in deprived areas: the COLONAV cluster randomized controlled trial.

BACKGROUND: The objective of this study was to assess the effectiveness of a Patient Navigation Intervention targeting deprived patients for Colo-Rectal Cancer (CRC) screening participation. METHODS: A cluster randomized controlled trial was conducted in 5 districts. Peer Lay Patient Navigators were recruited to operate in deprived areas. Eligible participants had to be between 50 and 74 years old, live in these deprived areas and receive an invitation to the nationally organized Colo-Rectal Cancer (CRC) screening during the study period. The theory-driven navigation intervention was deployed for 18 months. A population Health Intervention Research assessment method was used to assess effectiveness and context interaction. The primary criterion was screening participation at 12 months. RESULTS: Twenty-four thousand two hundred eighty-one individuals were included inside 40 clusters. The increase in participation in the intervention group was estimated at 23%, (ORa = 1.23, CI95% [1.07-1.41], p = 0.003). For the subgroup of individuals who participated, the time delay to participating was reduced by 26% (ORa = 0.74, CI95% [0.57-0.96], p = 0.021). Main factors modulating the effect of the intervention were: closeness of navigator profiles to the targeted population, navigators' abilities to adapt their modus operandi, and facilitating attachment structure. CONCLUSION: The ColoNav Intervention succeeded in demonstrating its effectiveness, for CRC screening. Patient Navigation should be disseminate with broader health promotion goals in order to achieve equity in health care. TRIAL REGISTRATION: clinicaltrials.gov NCT02369757 24/02/2015.

ColoNav: patient navigation for colorectal cancer screening in deprived areas - Study protocol.

BACKGROUND: The mass colorectal cancer screening program was implemented in 2008 in France, targeting 16 million French people aged between 50 and 74. The current adhesion is insufficient and the participation rate is even lower among the underserved population, increasing health inequalities within our health care system. Patient Navigation programs have proved their efficiency to promote the access to cancer screening and diagnosis. METHODS/DESIGN: The purpose of the study is to assess the implementation of a patient navigation intervention that has been described in another cultural environment and another health care system. The main objective of the program is to increase the colorectal cancer screening participation rate among the deprived population through the intervention of a navigator to promote the Fecal Occult Blood Test (FOBT) and complementary exams. We performed a multisite cluster randomized controlled trial, with three groups (one experimental group and two control groups) for 18 months. DISCUSSION: The study attempts to give a better understanding of the adhesion barriers to colorectal cancer screening among underserved populations. If this project is cost-effective, it could create a dynamic based on peer approaches that could be developed for other cancer screening programs and other chronic diseases. TRIAL REGISTRATION: NCT02369757.

Overestimation of moderate carotid stenosis assessed by both Doppler US and contrast enhanced 3D-MR angiography in the CARMEDAS study.

PURPOSE: To evaluate the agreement and diagnostic accuracy of Contrast enhanced magnetic resonance angiography (CE-MRA), Doppler ultrasound (DUS) and Digital subtraction angiography (DSA) in the assessment of carotid stenosis. METHODS: DUS, CE-MRA and DSA were performed in 56 patients included in the Carotide-angiographie par résonance magnétique-échographie-doppler-angioscanner (CARMEDAS) multicenter study with a carotid stenosis ≥ 50%. Three readers evaluated stenoses on CE-MRA and DSA (NASCET criteria). Velocities criteria were used for stenosis estimation on DUS. RESULTS: CE-MRA had a sensitivity and specificity of 96-98% and 66-83% respectively for carotid stenoses ≥ 50% and a sensitivity and specificity of 94% and 76-84% respectively for carotid stenoses ≥ 70%. The interobserver agreement of CE-MRA was excellent, except for moderate stenoses (50-69%). DUS had a sensitivity and specificity of 88 and 75% respectively for carotid stenoses ≥ 50% and a sensitivity and specificity of 83 and 86% respectively for carotid stenoses ≥ 70%. Combined concordant CE-MRA and DUS had a sensitivity and specificity of 100 and 85-90% respectively for carotid stenoses ≥ 50% and a sensitivity and specificity of 96-100% and 80-87% respectively for carotid stenoses ≥ 70%. The positive predictive value of the association CE-MRA and DUS for carotid stenoses ≥ 70% is calculated between 77 and 82% while the negative predictive value is calculated between 97 and 100%. CE-MRA and DUS have concordant findings in 63-72%, and the overestimations cases were recorded only for carotid stenosis ≤ 69%. CONCLUSION: Combined DUS-CE-MRA is excellent for evaluation of severe stenosis but remains debatable in moderate stenosis (50-69%) due to the risk of overestimations.