Complex Care Needs in Multiple Chronic Conditions: Population Prevalence and Characterization in Primary Care. A Study Protocol

Background: Chronicity, and particularly complex care needs for people with chronic diseases is one of the main challenges of health systems. Objective: To determine the population prevalence of people with chronic diseases and complex care needs and to characterize these needs considering features of health and social complexity in Primary Care. Design: Cross-sectional population-based study. Scope: Patients who have one or more chronic health conditions from three Primary Care urban centres of a reference population of 43.647 inhabitants older than 14 years old. Methodology: Data will be obtained from the review of electronical medical records. Complexity will be defined by: 1) the independent clinical judgment of primary care physicians and nurses and 2) the aid of three complexity domains (clinical and social). Patients with advanced chronic disease and limited life prognosis will be also described. Conclusions: This research protocol intends to describe and analyse complex care needs from a primary care professional perspective in order to improve knowledge of complexity beyond multimorbidity and previous consumption of health resources. Knowing about health and social complexity with a more robust empirical basis could help for a better integration of social and health policies and a more proactive and differentiated care approach in this most vulnerable population

Clinical and treatment outcomes of a second subcutaneous or intravenous anti-TNF in patients with ulcerative colitis treated with two consecutive anti-TNF agents: data from the ENEIDA registry

Background: Infliximab seems to be the most efficacious of the three available anti-TNF agents for ulcerative colitis (UC) but little is known when it is used as the second anti-TNF. Objectives: To compare the clinical and treatment outcomes of a second subcutaneous or intravenous anti-TNF in UC patients. Design: Retrospective observational study. Methods: Patients from the ENEIDA registry treated consecutively with infliximab and a subcutaneous anti-TNF (or vice versa), naïve to other biological agents, were identified and grouped according to the administration route of the first anti-TNF into IVi (intravenous initially) or SCi (subcutaneous initially). Results: Overall, 473 UC patients were included (330 IVi and 143 SCi). Clinical response at week 14 was 42.7% and 48.3% in the IVi and SCi groups (non-statistically significant), respectively. Clinical remission rates at week 52 were 32.8% and 31.4% in the IVi and SCi groups (nonsignificant differences), respectively. A propensity-matched score analysis showed a higher clinical response rate at week 14 in the SCi group and higher treatment persistence in the IVi group. Regarding long-term outcomes, dose escalation and discontinuation due to the primary failure of the first anti-TNF and more severe disease activity at the beginning of the second anti-TNF were inversely associated with clinical remission. Conclusion: The use of a second anti-TNF for UC seems to be reasonable in terms of efficacy, although it is particularly reduced in the case of the primary failure of the first anti-TNF. Whether the second anti-TNF is infliximab or subcutaneous does not seem to affect efficacy