From a theory of care‐seeking behavior, this study answered two questions: Do psychosocial variables (anxiety, utility, norm, and habit) and objective, facilitating conditions (e. g., regular practitioner) influence care‐seeking delay with a breast symptom directly, or are psychosocial influences moderated by facilitating conditions? Do demographic or clinical factors explain delay, controlling for psychosocial variables and facilitating conditions? Women with breast cancer symptoms (N= 106) completed questionnaire measures. Delay was measured by the days between symptom detection and first contact with the health system. Norm and having a regular practitioner were related inversely to delay. The influence of anxiety was moderated by having a regular practitioner. Among women lacking a practitioner, anxiety was related inversely to delay; among women with a practitioner, anxiety was not related to delay. Controlling for psychosocial variables and facilitating conditions, women of color delayed longer than did Caucasians. Findings can guide research and theory about care seeking.
<b><i>Background:</i></b> By inhibiting the adsorption of protein and platelets, surface-modifying macromolecules (SMMs) may improve the hemocompatibility of hemodialyzers. This trial aims to assess the performance and safety of a novel dialyzer with a fluorinated polyurethane SMM, Endexo™. <b><i>Methods:</i></b> This prospective, sequential, multicenter, open-label study (NCT03536663) was designed to meet regulatory requirements for clinical testing of new hemodialyzers, including assessment of the in vivo ultrafiltration coefficient (Kuf). Adults prescribed thrice-weekly hemodialysis were eligible for enrollment. After completing 12 hemodialysis sessions with an Optiflux® F160NR dialyzer, patients received 38 sessions with the dialyzer with Endexo. Evaluated parameters included the in vivo Kuf of the dialyzer with Endexo extent of removal of urea, albumin, and β2-microglobulin (β2M), as well as complement activation. <b><i>Results:</i></b> Twenty-three patients received 268 hemodialysis treatments during the Optiflux period, and 18 patients received 664 hemodialysis treatments during the Endexo period. Three serious adverse events were reported, and none of them were considered device related. No overt complement activation was observed with either dialyzer. Both dialyzers were associated with comparable mean increases in serum albumin levels from pre- to posthemodialysis (Optiflux: 7.9%; Endexo: 8.0%). These increases can be viewed in the context of a mean increase in hemoglobin of approximately 5% and a mean ultrafiltration volume removed of approximately 2.2 L. The corrected mean β2M removal rate was 47% higher during the Endexo period (67.73%). Mean treatment times (208 vs. 205 min), blood flow rates (447.7 vs. 447.5 mL/min), dialysate flow rates (698.5 vs. 698.0 mL/min), urea reduction ratio (82 vs. 81%), and spKt/V (2.1 vs. 1.9) were comparable for the Endexo and Optiflux periods, respectively. The mean (SD) Kuf was 15.85 (10.33) mL/h/mm Hg during the first use of the dialyzer with Endexo (primary endpoint) and 16.36 (9.92) mL/h/mm Hg across the Endexo period. <b><i>Conclusions:</i></b> The safety of the novel dialyzer with Endexo was generally comparable to the Optiflux dialyzer, while exhibiting a higher β2M removal rate.
Background By inhibiting the adsorption of protein and platelets, surface-modifying macromolecules (SMMs) may improve the hemocompatibility of hemodialyzers. This trial aims to assess the performance and safety of a novel dialyzer with a fluorinated polyurethane SMM, Endexo™, blended into the membrane during manufacturing. Methods This prospective, sequential, multicenter, open-label study enrolled adults prescribed thrice-weekly hemodialysis. After completing 12 hemodialysis sessions with an Optiflux ® F160NR dialyzer , patients received 38 sessions with the dialyzer with Endexo. Evaluated parameters included the extent of removal of urea, albumin, and β2-microglobulin (β2M), as well as complement activation.Results Twenty-three patients received 268 hemodialysis treatments during the Optiflux period, and 18 patients continued on to receive 664 hemodialysis treatments during the Endexo period. Mean treatment times (208 vs 205 min), blood flow rates (447.7 vs 447.5 mL/min), dialysate flow rates (698.5 vs 698.0 mL/min), urea reduction ratio (82% vs 81%) and spKt/V (2.1 vs 1.9) were comparable for the Endexo and Optiflux periods, respectively. No overt complement activation was observed. Both dialyzers were associated with comparable mean increases in serum albumin levels from pre- to post- hemodialysis (Optiflux: 7.9%; Endexo: 8.0%). The corrected mean β2M removal rate was 47% higher during the Endexo period (67.73%). Three serious adverse events were reported, none of them device-related. Conclusions The performance of the novel dialyzer with Endexo was generally comparable to the Optiflux dialyzer, while exhibiting a higher β2M removal rate. Additional studies are needed to determine whether this novel dialyzer can be incorporated into heparin-free hemodialysis approaches.
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