RESUMO
BACKGROUND: therapeutic monitoring of anti-TNF drugs and anti-drug antibody levels are useful for clinical decision-making, via the rationalization and optimization of the use of anti-TNF treatments. The objective of the present study was to validate the model of Ternant et al., in a cohort of patients with inflammatory bowel diseases (IBD). This model was originally established for patients with rheumatoid arthritis and was used in this study to optimize the adalimumab (ADA) dose and predict ADA trough levels (ATL). METHODS: this study used concentration data points from 30 IBD patients who received ADA treatment between 2014 and 2015. A goodness-of-fit of the model was determined by evaluating the relationship between the observed ATL values and population model-predicted values (PRED) or individual model-predicted values (IPRED). RESULTS: a total of 51 ADA concentration points were analyzed. The bias of the model was 2.39 (95% CI, 1.63-3.15) for PRED and 0.63 (95% CI, 0.23-1.03) for IPRED. The precision was 3.57 (95% CI, 2.90-4.13) and 1.53 (95% CI, 1.22-1.80), respectively. CONCLUSIONS: therapeutic drug monitoring involving ATL may allow the optimization of the treatment of IBD patients. The validation results of the phamacokinectic (PK) model for ADA in IBD patients are inadequate. However, additional studies will strengthen the bias and precision of the model.
Assuntos
Adalimumab/farmacocinética , Adalimumab/uso terapêutico , Anti-Inflamatórios/farmacocinética , Anti-Inflamatórios/uso terapêutico , Doenças Inflamatórias Intestinais/tratamento farmacológico , Modelos Químicos , Adulto , Estudos de Coortes , Feminino , Humanos , Masculino , Pessoa de Meia-IdadeRESUMO
BACKGROUND AND AIMS: nursing management of inflammatory bowel disease (IBD) is highly relevant for patient care and outcomes. However, there is evidence of substantial variability in clinical practices. The objectives of this study were to develop standards of healthcare quality for nursing management of IBD and elaborate the evaluation tool "Nursing Care Quality in IBD Assessment" (NCQ-IBD) based on these standards. METHODS: a 178-item healthcare quality questionnaire was developed based on a systematic review of IBD nursing management literature. The questionnaire was used to perform two 2-round Delphi studies: Delphi A included 27 IBD healthcare professionals and Delphi B involved 12 patients. The NCQ-IBD was developed from the list of items resulting from both Delphi studies combined with the Scientific Committee´s expert opinion. RESULTS: the final NCQ-IBD consists of 90 items, organized in13 sections measuring the following aspects of nursing management of IBD: infrastructure, services, human resources, type of organization, nursing responsibilities, nurse-provided information to the patient, nurses training, annual audits of nursing activities, and nursing research in IBD. Using the NCQ-IBD to evaluate these components allows the rating of healthcare quality for nursing management of IBD into 4 categories: A (highest quality) through D (lowest quality). CONCLUSION: the use of the NCQ-IBD tool to evaluate nursing management quality of IBD identifies areas in need of improvement and thus contribute to an enhancement of care quality and reduction in clinical practice variations.
Assuntos
Doenças Inflamatórias Intestinais/enfermagem , Indicadores de Qualidade em Assistência à Saúde , Qualidade da Assistência à Saúde/normas , Inquéritos e Questionários , Técnica Delphi , HumanosRESUMO
BACKGROUND: Anti-TNF treatment is effective for Crohn's disease (CD); however, some patients did not achieve remission with these drugs. AIMS: To evaluate the short-term effectiveness of a second anti-TNF in CD patients who did not achieve remission with the first one and to assess its durability. METHODS: Patients who did not achieve remission with their first anti-TNF were included. The short-term response of the second anti-TNF was assessed, the long-term response was evaluated in patients who achieved remission (Kaplan-Meier). Cox-regression was performed to identify predictors of loss of efficacy. RESULTS: In all, 118 CD patients received a second anti-TNF after primary failure of the first. The first anti-TNF was discontinued because of non-response in 54% of patients and partial response in 46%. Fifty-one percent of patients achieved remission in the short-term. The probability of remission was lower in patients for whom the drug indication was perianal disease (OR=0.3, 95% CI=0.1-0.7, P=0.005). The dose was increased in 33% of patients, and 37% achieved/regained remission. The probability of maintaining remission was 76%, 68% and 64% at 12, 18 and 24 months, respectively. CONCLUSIONS: Approximately half of the patients achieved remission with a second anti-TNF after primary failure of the first, this strategy was less effective in patients with perianal disease.
Assuntos
Adalimumab/uso terapêutico , Anti-Inflamatórios/uso terapêutico , Doença de Crohn/tratamento farmacológico , Fármacos Gastrointestinais/uso terapêutico , Infliximab/uso terapêutico , Adulto , Feminino , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Indução de Remissão , Estudos Retrospectivos , Espanha , Falha de Tratamento , Fator de Necrose Tumoral alfa/antagonistas & inibidoresRESUMO
BACKGROUND: Nurses play an important role in the multidisciplinary management of inflammatory bowel disease (IBD), but little is known about this role and the associated resources. OBJECTIVE: To improve knowledge of resource availability for health care activities and the different organizational models in managing IBD in Spain. METHODS: Cross-sectional study with data obtained by questionnaire directed at Spanish Gastroenterology Services (GS). Five GS models were identified according to whether they have: no specific service for IBD management (Model A); IBD outpatient office for physician consultations (Model B); general outpatient office for nurse consultations (Model C); both, Model B and Model C (Model D); and IBD Unit (Model E) when the hospital has a Comprehensive Care Unit for IBD with telephone helpline, computer, including a Model B. Available resources and activities performed were compared according to GS model (chi-square test and test for linear trend). RESULTS: Responses were received from 107 GS: 33 Model A (31%), 38 Model B (36%), 4 Model C (4%), 16 Model D (15%) and 16 Model E (15%). The model in which nurses have the most resources and responsibilities is the Model E. The more complete the organizational model, the more frequent the availability of nursing resources (educational material, databases, office, and specialized software) and responsibilities (management of walk-in appointments, provision of emotional support, health education, follow-up of drug treatment and treatment adherence) (p<0.05). CONCLUSIONS: Nurses have more resources and responsibilities the more complete is the organizational model for IBD management. Development of these areas may improve patient outcomes.
Assuntos
Gastroenterologia/organização & administração , Hospitais Privados/organização & administração , Hospitais Públicos/organização & administração , Doenças Inflamatórias Intestinais/enfermagem , Papel do Profissional de Enfermagem , Alocação de Recursos/organização & administração , Análise de Variância , Estudos Transversais , Gastroenterologia/estatística & dados numéricos , Hospitais Privados/estatística & dados numéricos , Hospitais Públicos/estatística & dados numéricos , Modelos Organizacionais , Recursos Humanos de Enfermagem Hospitalar/organização & administração , Espanha , Inquéritos e QuestionáriosRESUMO
BACKGROUND: The purpose of quality of care programs is to improve patient outcomes. In programs targeting patients with inflammatory bowel disease (IBD), nurses play a key role. AIM: To know the available scientific evidence on the quality of care in IBD management, at the levels of structure, process and outcome, in relation to nurses. METHODS: Systematic search in MEDLINE, EMBASE, Índice Médico Español, Cochrane Library, and grey literature. Inclusion criteria were: 1) documents referring IBD; 2) documents providing relevant information on nurses' involvement in the management of IBD; and 3) an original article. RESULTS: A total of 284 documents were identified, 15 of which were included: 8 related with structure, 12 with process, and 6 with outcomes. Some documents treated more than one level. At the level of structure, services should incorporate specialist nurses as part of the multidisciplinary team, as well as resources to facilitate patient access to nursing care. Notable at the process level, organizational aspects and nurses' competencies and skills in the management of IBD have been described. Among the outcomes mentioned are clinical outcomes, quality of life, and patient satisfaction attributable to nursing staff. No evidence was found about the association between structure or process issues with patient outcomes. Most of the studies reviewed have methodological limitations. CONCLUSIONS: The available evidence provide useful information for the design of standards of structure and process relating to nurses' management of IBD. The IBD nurses' challenge is to provide evidence that these standards help improve health outcomes in patients.