Metabolic profiling of night shift work - The HORMONIT study.

Mechanistic studies are needed to understand how rotating shift work perturbs metabolic processing. We collected plasma samples (n = 196) from 49 males, rotating car factory shift workers at the beginning and end of a night-shift (22:00-06:00 h) and day-shift (06:00 h-14:00 h). Samples underwent targeted LC-MS/MS metabolomics and concentrations of 130 metabolites were log2-transformed and pareto-scaled. An elastic net selected the most influential metabolites for linear mixed models examining within-person variation in metabolite levels at night-shift end (06:00 h) compared to day-shift start (06:00 h). Quantitative enrichment analysis explored differentially enriched biological pathways between sample time points. We included 20 metabolites (amino acids, biogenic amines, acylcarnitines, glycerophospholipids) in mixed models. Night-shift was associated with changes in concentrations of arginine (geometric mean ratio [GMR] 2.30, 95%CI 1.25, 4.23), glutamine (GMR 2.22, 95%CI 1.53, 3.24), kynurenine (GMR 3.22, 95%CI 1.05, 9.87), lysoPC18:2 (GMR 1.86, 95%CI 1.11, 3.11), lysoPC20:3 (GMR 2.48, 95%CI 1.05, 5.83), PCaa34:2 (GMR 2.27, 95%CI 1.16, 4.44), and PCae38:5 (GMR 1.66, 95%CI 1.02, 2.68). Tryptophan metabolism, glutathione metabolism, alanine metabolism, glycine and serine metabolism, and urea cycle were pathways differing between shifts. Night shift work was associated with changes in metabolites and the perturbation of metabolic and biochemical pathways related to a variety of health outcomes.

Disruption of cellular immune response among male rotating night shift workers in Spain- The HORMONIT study.

Introduction: Preliminary studies suggest that night shift work is associated with a desynchronization of rhythmic immune markers, possibly explaining the increased risk of infection, cardiometabolic disorders, and cancer in shift workers. Methods: This study included 51 male rotating shift workers from a car industry in Barcelona, Spain, sampled twice toward the end of a 3-week night shift (22:00-06:00 h) and a 3-week day shift (06:00-14:00 h) rotation. We collected four blood samples per worker, at the start and end of each shift. We measured 27 cytokines, chemokines and growth factors in plasma samples by luminex using the Cytokine Human Magnetic 30-Plex Panel LHC6003M and applied linear mixed models to examine within-person associations between shift work and analytes' concentrations, comparing samples taken at 06:00 h on a day and night shift. We also conducted a factor analysis using analyte concentrations from all 4 time points for each individual to identify common factors and determine if these factors were altered by shift work. Results: We observed lower levels of 15 analytes in the night shift compared to the day shift including cytokines (pro-inflammatory TNF-α, IL-2R; anti-inflammatory IL1-RA; Th1 IL-2, Th2 IL-4 and Th17 Il-17), chemokines (IP-10, MIP-1α, MIP-1ß, RANTES) and growth factors (EGF, G-CSF, HGF, VEGF, FGF). In a factor analysis, three factors were identified. The main factor (Factor 1), explaining 57% of the variance and including IL-1ß, IL-12, IL-15, MIP-1α, MIP-1ß, EGF and FGF; and another factor (Factor 3) explaining 10% of the variance and including the Th1 cytokine IL-12, were inversely associated with the night shift (coefficient: -0.17, 95%CI -0.32 to -0.01 and coefficient: -0.22, 95%CI -0.38, -0.06, for Factors 1 and 3, respectively). Our results indicate that night shift disrupts the levels of several immune markers, which could contribute to the increased risk of infections and cancer reported in night shift workers. Conclusion: Night shift is associated with disruption of multiple immune response pathways.

Changes in melatonin and sex steroid hormone production among men as a result of rotating night shift work - the HORMONIT study.

OBJECTIVE: Data from real world settings on circadian disruption and subsequent hormone-related changes may explain the higher risk of hormone-dependent cancers among night shift workers.The present study examines the melatonin and sex steroid hormone levels among night shift workers. METHODS: We included 44 male, rotating shift workers from a car factory in Spain, sampled both at the end of a 3-week night shift (22:00-06:00 hrs) and a 3-week early morning shift (06:00-14:00 hrs). Participants collected all urine voids over 24-hours during each shift. Urinary concentrations of sex steroid hormones (estrogens, androgens and progestogens) and 6-sulfatoxymelatonin (aMT6s, major melatonin metabolite) were determined. Individual cosinor analysis was used to derive the acrophase (peak time) and area under the curve (total production). Linear mixed models examined intraindividual associations between night shift work and log-transformed 24-hour peak time and total production of hormones compared to early morning shift work. RESULTS: The acrophase was delayed during the night shift for aMT6s [geometric mean difference (GMD) 7.53 hrs, 95% confidence interval (CI) 4.46-10.60], androgens (eg, testosterone: GMD 6.83 hrs, 95% CI 0.34-13.32) and progestogens (eg, 17-hydroxyprogesterone: GMD 4.54 hrs, 95% CI 2.92-6.16) compared to the early morning shift. We found a higher production of adrenal androgen 11-oxoandrosterone/11-oxoetiocholanolone [geometric mean ratio (GMR) 1.43, 95% CI 1.12-1.81], and a lower production of adrenal progestogen 16-cysteinylprogesterone (GMR 0.79, 95% CI 0.67-0.93) during the night shift compared to the early morning shift levels. CONCLUSIONS: Night shift work was associated with melatonin and sex hormone-related changes in timing and total production, providing insight into the mechanistic path for its association with hormone-dependent cancer.

Use of Social Media Apps by Nurses for Professional Purposes in Catalonia: Cross-Sectional Study.

Over the last few years, the use of social media mobile applications or apps (SMAs) has increased exponentially. The potential advantages of using these technologies by health professionals in clinical settings have been discussed many times. Considering that the nursing profession is the largest segment of the healthcare workforce in the majority of countries in the world, the impact of using these apps by these professionals is very relevant. The objectives of this study were, firstly, to determine if nurses were using SMAs professionally and the most frequent SMAs used and secondly, to find out if, among nurses, there is a need for training in the use of these mobile applications for professional purposes. The study is a descriptive cross-sectional study based on an Internet survey of 1,293 nurses in Catalonia (Spain). The average age of the respondents who had these apps installed on their mobile phones or tablets, was 43.12 (SD ± 11.32) years old. WhatsApp was the most frequent SMAs used by nurses for professional purposes, and 79.2 % of nurses mentioned they used it several times a day. WhatsApp was the preferred SMAs for communicating with colleagues (31.2% of nurses) followed by Facebook (18.4%) and Twitter (11.3%). In contrast, the use of the SMAs was much less frequent as a means of communication with patients (7.2% in the case of WhatsApp). Nurses expressed their need for specific training in the use of these apps for professional purposes, indicating the interest and potential impact of the introduction of these technologies in clinical environments. The use of SMAs is quite common among nurses at the moment of the survey, and WhatsApp was the most popular one to support their professional activity. Based on the results of the survey, the Nursing Association of Barcelona (COIB) will consider the design of specific training activities in the use of SMAs in clinical settings.

Correction: Use of Health Apps by Nurses for Professional Purposes: Web-Based Survey Study.

[This corrects the article DOI: 10.2196/15195.].

Use of Health Apps by Nurses for Professional Purposes: Web-Based Survey Study.

BACKGROUND: In the last few years, the number of mobile apps for health professionals has increased exponentially. Nevertheless, there is a lack of knowledge about the professional use, training requirements, and quality perception of these apps among health care professionals such as nurses. Considering that the nursing profession is the largest segment of health care workforce in many countries such as Spain, the impact of the use of health apps by these professionals can be critical to the future of modern health care. OBJECTIVE: The main objective of this study was to determine if nurses were using health apps professionally and what types of apps they were using. The secondary objectives were (1) to find out if, among nurses, there is a need for training in the use of health apps and (2) to explore nurses' perceptions of health professional apps, determining whether there is a need for a certification process for health apps and the type of institution or organization that should review and validate these apps for professional use. METHODS: After an initial piloting survey, all registered nurses at the Nursing Association of Barcelona were invited to participate in a 34-item online survey. Eventually, 1293 nurses participated in the survey; however, 52 did not complete the survey properly, omitting both age or gender information, and they were excluded from the analysis. RESULTS: About half of the respondents (600/1241, 48.35%) had health professional apps installed on their devices and were included for analysis. Most participants in the survey were women (474/600, 79.0%) and the remaining were men (126/600, 21.0%). The most popular types of apps used and installed among nurses were related to drug information, health calculators, and health guidelines. Overall, 97.0% (582/600) of nurses thought that the health apps should be certified, and 80.0% (480/600) agreed that the certification process should be carried out by professional or health institutions. Furthermore, 14.5% (87/600) of participants mentioned that they were asked by their patients to prescribe a health app and only 6.5% (28/430) recommended them often. Most nurses (354/433, 81.8%) who answered the question about the importance of receiving specific training on using and prescribing health apps considered this point a very relevant issue. CONCLUSIONS: About half of the nurses in Catalonia use health apps for professional purposes, and they believe that these types of tools should be validated and certified by health or professional institutions before using them in clinical environments. Although the prescription of health apps in clinical environments is infrequent among nurses, they would be willing to prescribe apps if they were certified by a health organization. Finally, among nurses, there is a need for training in using and prescribing health apps for health care purposes.

Delphi consensus statement: Quality Indicators for Inflammatory Bowel Disease Comprehensive Care Units.

BACKGROUND AND AIMS: While it is commonly accepted that Inflammatory bowel disease (IBD) Comprehensive Care Units (ICCUs) facilitate the delivery of quality care to Crohn's disease and ulcerative colitis patients, it remains unclear how an ICCU should be defined or evaluated. The aim of the present study was to develop a comprehensive set of Quality Indicators (QIs) of structure, process, and outcomes for defining and evaluating an ICCU. METHODS: A Delphi consensus-based approach with a standardized three-step process was used to identify a core set of QIs. The process included an exhaustive search using complementary approaches to identify potential QIs, and two Delphi voting rounds to select the QIs defining the core requirements for an ICCU. RESULTS: The consensus selected a core set of 56 QIs (12 structure, 20 process and 24 outcome). Structure and process QIs highlighted the need for multidisciplinary management and continuity of care. The minimal IBD team should include an IBD nurse, gastroenterologists, radiologists, surgeons, endoscopists and stoma management specialists. ICCUs should be able to provide both outpatient and inpatient care and admission should not break the continuity of care. Outcome QIs focused on the adequate prophylaxis of disease complication and drug adverse events, the need to monitor appropriateness of treatment and the need to reinforce patient autonomy by providing adequate information and facilitating the patients' participation in their own care. CONCLUSIONS: The present Delphi consensus identified a set of core QIs that may be useful for evaluating and certifying ICCUs.

Inflammatory bowel disease patient's satisfaction with healthcare services received. Physicians' and nurses' perceptions.

BACKGROUND: patient satisfaction with healthcare services provided for inflammatory bowel diseases (IBD) is essential due to high resources use. OBJECTIVES: the study aimed to describe patient satisfaction with healthcare services using the CACHE questionnaire and to assess gastroenterologist and nurse perception on patients' satisfaction. METHODS: observational multicentric prospective study in 35 Spanish hospitals. Patients included had Crohn's disease or ulcerative colitis. The study was approved by the Hospital Universitari Vall d'Hebron Ethics Committee. Scheduled study visits: baseline (patient sociodemographics and clinical data were collected), 2-4 and 6-months. Patient satisfaction with healthcare was assessed by CACHE questionnaire at each visit; it scores from 0-least satisfaction to 100-highest satisfaction.Gastroenterologists and nurses answered once an adapted questionnaire. RESULTS: participating 290 patients (54.2 % males, 41.3 years old), 62 gastroenterologists and 47 nurses. At baseline mean (SD) CACHE score was 81.7 (10.9); satisfaction with clinician care was the highest, patient information the lowest. Scores did not change across study. Gastroenterologist global score was 72.5 (9.8); Staff Care satisfaction was the highest, patient information the lowest. All scores were significantly lower than patients'. Nurses' global score was 82.2 (8.5), clinician care satisfaction was the highest, centre facilities the lowest. Scores on satisfaction with clinician care, centre facilities, and patient information scored statistically lower than patients'. No relationship was found between patients' satisfaction and patients characteristics. conclusions: IBD patients are satisfied with healthcare services provided, even though the information may be improved. Nurses' perception is similar to that of patients, physicians have a lower perception.

Development of quality standards in inflammatory bowel disease management and design of an evaluation tool of nursing care.

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.

Questionnaries for measuring fatigue and its impact on health perception in inflammatory bowel disease.

INTRODUCTION: fatigue impacts perceived health, but its importance in inflammatory bowel disease is not known. OBJECTIVES: to define the applicability of the fatigue measurement questionnaires and analyze it in patients with Crohn´s disease and ulcerative colitis. MATERIAL AND METHODS: in a first phase, the psychometric properties of 3 fatigue measurement questionnaires were determined in 99 patients: Daily Fatigue Impact Scale, Fatigue Severity Scale, and Modified Fatigue Impact Scale. In a second phase, fatigue status and its relationship to disease and quality of life was determined in 127 patients and 69 healthy controls. RESULTS: the first part of the study showed the applicability of the questionnaires listed in inflammatory bowel disease, the Daily Fatigue Impact Scale (DFIS) having the best correlation with the quality of life and clinical activity. In the second phase, significantly higher levels of fatigue were observed in active disease than in disease in remission and healthy controls (p < 0,05). The severity of fatigue was significantly correlated with quality of life (r = -0.66 and -0.72 between IBDQ-9 and DFIS and in Crohn´s disease and ulcerative colitis, respectively) and with disease activity (r = 0.25 and Crohn´s disease and ulcerative colitis, respectively, p < 0.05). CONCLUSIONS: in inflammatory bowel disease, fatigue measurement questionnaires have good properties and show that fatigue is an important manifestation of the disease, which has a significant impact on quality of life of patients.

Desarrollo de estándares de calidad para la enfermedad inflamatoria intestinal y diseño de un instrumento de evaluación de los cuidados de enfermería / Development of quality standards in inflammatory bowel disease management and design of an evaluation tool of nursing care

Introducción y objetivos: el manejo de la enfermedad inflamatoria intestinal (EII) por enfermería es muy relevante, sin embargo, existe una gran variabilidad en su práctica clínica. El objetivo de esta investigación es desarrollar estándares de calidad asistencial del manejo de la EII por enfermería, para elaborar un “Instrumento de Evalua - ción de la Calidad Asistencial de la EII por Enfermería” (IEC-EII). Métodos: tras una búsqueda bibliográfica del manejo de la EII por enfermería se elaboró un cuestionario de 178 ítems de calidad asistencial. Con este cuestionario, se realizaron dos estudios Delphi a dos rondas: Delphi A dirigido a 27 profesionales sanitarios en EII y Delphi B a 12 pacientes. Con los ítems de ambos estudios Delphi, se elaboró una lista que, junto con la opinión experta del Comité Científico, contribuyó a desarrollar el IEC-EII. Resultados: el IEC-EII se compone de 90 ítems, subdivididos en 13 dimensiones que miden aspectos del manejo de la EII por enfermería como: infraestructura, servicios, recursos humanos, tipo de organización, competencias asumidas por enfermería, información de enfermería al paciente, formación de enfermería, revisiones anuales de la actividad de enfermería e investigación de enfermería de EII. La evaluación de estos aspectos mediante el IEC-EII permite clasificar la calidad asistencial en EII por enfermería en 4 categorías de la A a la D. Siendo A el nivel de calidad superior y D el inferior. Conclusiones: el IEC-EII puede contribuir a aumentar la calidad asistencial de enfermería en EII y reducir su variabilidad, puesto que la evaluación ayudará a detectar sus deficiencias mejorables (AU)

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 in 13 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). Conclusions: 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 (AU)

Cuestionarios de medida e impacto de la fatiga en la percepción de salud en la enfermedad inflamatoria intestinal / Questionnaires for measuring fatigue and its impact on health perception in inflammatory bowel disease

Introducción: la fatiga repercute en la salud percibida, pero se desconoce su relevancia en la enfermedad inflamatoria intestinal. Objetivos: definir la aplicabilidad de cuestionarios de medida de fatiga y analizarla en pacientes con enfermedad de Crohn y colitis ulcerosa. Material y métodos: en una primera fase, en 99 pacientes se determinaron las propiedades psicométricas de 3 cuestionarios de medida de fatiga: Escala del Impacto Diario de Fatiga, Escala de Gravedad de la Fatiga y Escala Modificada del Impacto de Fatiga. En una segunda fase, se determinó el estado de fatiga y su relación con la enfermedad y la calidad de vida en 127 pacientes y 69 controles sanos. Resultados: la primera parte del estudio, demostró la aplicabilidad de los cuestionarios citados en la enfermedad inflamatoria intestinal, siendo la Escala del Impacto Diario de Fatiga (EIDF) el de mejor correlación con la calidad de vida y la actividad clínica. En la segunda fase, se objetivaron unos niveles significativamente superiores de fatiga en la enfermedad activa que en la enfermedad en remisión y los controles sanos (p < 0,05). La intensidad de la fatiga se correlacionó de forma significativa con la calidad de vida (r = -0,66 y -0,72 entre el IBDQ- 9 y EIDF en enfermedad de Crohn y colitis ulcerosa respectivamente) y con la actividad de la enfermedad (r = 0,25 y 0,33 en la enfermedad de Crohn y colitis ulcerosa respectivamente, p < 0,05). Conclusiones: en la enfermedad inflamatoria intestinal los cuestionarios de medida de fatiga tienen propiedades adecuadas y demuestran que la fatiga es una manifestación importante de la enfermedad, que repercute de forma significativa en la calidad de vida de los pacientes(AU)

Introduction: fatigue impacts perceived health, but its importance in inflammatory bowel disease is not known. Objectives: to define the applicability of the fatigue measurement questionnaires and analyze it in patients with Crohn’s disease and ulcerative colitis. Material and methods: in a first phase, the psychometric properties of 3 fatigue measurement questionnaires were determined in 99 patients: Daily Fatigue Impact Scale, Fatigue Severity Scale, and Modified Fatigue Impact Scale. In a second phase, fatigue status and its relationship to disease and quality of life was determined in 127 patients and 69 healthy controls. Results: the first part of the study showed the applicability of the questionnaires listed in inflammatory bowel disease, the Daily Fatigue Impact Scale (DFIS) having the best correlation with the quality of life and clinical activity. In the second phase, significantly higher levels of fatigue were observed in active disease than in disease in remission and healthy controls (p < 0,05). The severity of fatigue was significantly correlated with quality of life (r = -0.66 and -0.72 between IBDQ-9 and DFIS and in Crohn’s disease and ulcerative colitis, respectively) and with disease activity (r = 0.25 and Crohn’s disease and ulcerative colitis, respectively, p < 0.05). Conclusions: in inflammatory bowel disease, fatigue measurement questionnaires have good properties and show that fatigue is an important manifestation of the disease, which has a significant impact on quality of life of patients(AU)

Development and testing of a new instrument to measure patient satisfaction with health care in inflammatory bowel disease: the CACHE questionnaire.

BACKGROUND: Currently, there is no tool to evaluate satisfaction of patients with inflammatory bowel disease (IBD) with health care services. The objective of this study was to develop and test a new specific instrument to measure satisfaction with health care in patients with IBD. METHODS: The questionnaire was developed using a literature review, a focus group with clinical experts, and administration of a provisional version to 20 patients with IBD. The final version of the questionnaire was validated in a longitudinal multicenter study in adult patients with IBD. The instrument's underlying dimension structure was analyzed using factor analysis, and its feasibility, reliability, and validity were assessed. RESULTS: The final version of the CACHE questionnaire contains 31 items scored on a 5-point Likert-type scale. Scores were standardized to a range from 0 (minimum satisfaction) to 100 (maximum satisfaction). Factor analysis revealed 6 factors (staff care, clinician care, facilities, information, center accessibility, and support received), which explained 56% of variance. Overall, 91% of patients answered all items. Cronbach's alpha for the overall score was 0.93. There were no statistically significant correlations between the overall score and sociodemographic and clinical variables, but there was a statistically significant correlation between the time spent in the waiting room and the item measuring satisfaction with that aspect. There were no statistically significant changes in the overall score between the visits. The effect size was 0.016. CONCLUSIONS: The CACHE questionnaire covers aspects relevant to the assessment of health care quality in patients with IBD and has proved to be feasible, reliable, and valid.

Satisfaction of health care professionals managing patients with inflammatory bowel disease.

BACKGROUND AND AIMS: The aim of the present study was to analyze the satisfaction of health care professionals who attend patients with inflammatory bowel disease (IBD) and to determine the variables more related with satisfaction/dissatisfaction. METHODS: Cross-sectional, self-administered written 15-item questionnaire was evaluated using a Likert scale, completed by Spanish gastroenterologists and nurse practitioners specialized in IBD patient care. RESULTS: A total of 202 surveys, 133 physicians (65.8%) and 69 nurses (34.2%) were conducted. Global scoring of satisfaction was 54.0 for physicians and 64.2 for nurses (p<0.001). In both groups the highest scores were achieved in those items related to their professional careers and management of personal and professional lives as well as those that refer to their interdisciplinary relationship with other medical units, management of patients within the hospital setting and finally communication with the patient. The items that attained the lowest score included those related to the length and staff available for the medical consult, work environment and the balance among health care provider needs for contribution, recognition and fulfillment. With regard to the variables involved with satisfaction, the results show that those physicians that only took care of IBD patients achieved a higher degree of satisfaction. This could be related with the fulfillment of their own professional expectations. CONCLUSIONS: The level of satisfaction of health care professionals that take care of IBD patients is low and may impact on patient care. Therefore, new strategies to increase the degree of satisfaction of IBD health care providers should be implemented.

Restoration of quality of life of patients with inflammatory bowel disease after one year with antiTNFα treatment.

BACKGROUND: Inflammatory bowel disease impairs patients' health related quality of life (HRQOL). AntiTNFα agents control disease activity effectively. An ambitious goal of treatment is to achieve the normalization of health. This can be assessed by using a cut-off scoring threshold of the IBDQ-36 questionnaire. It has not been established if antiTNFα treatment is able to restore to normal patients' HRQOL. AIMS: To determine whether patients with Crohn's disease (CD) and ulcerative colitis (UC) in clinical remission after one year treatment with antiTNFα agents achieve normalization of their HRQOL. METHODS: Observational and cross-sectional study in patients treated with antiTNFα for one year and in sustained clinical remission. Patients completed the specific questionnaire IBDQ-36. Complete restoration of health was considered achieved when global score of IBDQ-36 was higher than 209 points. RESULTS: 54 patients (43 with CD and 11 with UC) were included. Thirty patients received adalimumab and 24 infliximab. Median global score of the IBDQ-36 was 231, without differences between CD and UC (228 vs 235 respectively, p=ns). Normalization of HRQOL was achieved in all 11 UC patients and in 29 out of 43 CD patients (67%). In our sample population, restoration of health was significantly more frequent in UC than in CD (p<0.05). CONCLUSIONS: One-year clinical remission induced by antiTNFα treatment restores perception of health to normal in most patients with IBD.

Nursing resources and responsibilities according to hospital organizational model for management of inflammatory bowel disease in Spain.

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.

Contribution of nurses to the quality of care in management of inflammatory bowel disease: a synthesis of the evidence.

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.

Validation of the Spanish version of a questionnaire to measure quality of care through the eyes of patients with inflammatory bowel disease (QUOTE-IBD).

BACKGROUND: Crohn's disease (CD) and ulcerative colitis (UC) are chronic immunoinflammatory diseases that place a considerable burden on patients, their families, and society. Quality of care plays an important role for patients. A questionnaire to measure quality of care through the eyes of patients with inflammatory bowel disease (QUOTE-IBD) has been designed and validated specifically for the English language and culture. The objective was to translate the QUOTE-IBD into Spanish and to determine its validity in patients with IBD. METHODS: This is a prospective study in 2 phases: first, translation and validation of the Spanish QUOTE-IBD. Translation was based on the validated QUOTE-IBD. Second, once the complete translation was finished, comprehension of the items was assessed with a specific questionnaire in a reduced number of patients. Criterion validity was assessed with the Pearson's correlation coefficient between scores of the QUOTE-IBD and visual analog scales (VAS). In order to analyze the reproducibility of the Spanish QUOTE-IBD, the questionnaire was completed by stable patients twice, with a span of time of at least 4 weeks. RESULTS: A total of 103 patients (CD: 61, UC: 42) were included in the study. Pearson's correlation coefficient between total care Spanish QUOTE-IBD and VAS of health care items was 0.34 (P < 0.001). Correlations among all 6 care dimensions score of Spanish QUOTE-IBD and VAS were statistically significant (P < 0.01). Results of first and second administration of total care and dimensional care scores of Spanish QUOTE-IBD in 46 stable patients were not different. CONCLUSIONS: The Spanish QUOTE-IBD has proved to be a valid instrument to measure the quality of health care for patients with CD and UC.

Unstable composition of the fecal microbiota in ulcerative colitis during clinical remission.

BACKGROUND AND AIM: Studies have identified abnormal characteristics of the gut microbiota in patients with active IBD, but whether the changes are causal or secondary to inflammation remains uncertain. We investigated dynamics of fecal microbiota in ulcerative colitis (UC) during remission by genomic technology. PATIENTS AND METHODS: Patients in clinical remission and on stable maintenance mesalazine therapy were recruited (N = 33). Fecal samples were collected at regular intervals over a period of 1 yr. Sixteen patients who remained in remission and eight healthy controls were included in the analysis. Variable V6 to V8 regions of the 16S rRNA gene in DNA extracts from fecal samples were amplified by polymerase chain reaction. Amplicons were separated by denaturant gradient gel electrophoresis, band profiles were compared by software, and similarity indices were calculated from densitometric curves. RESULTS: Band profiles showed unique patterns with low similarity index between individuals, suggesting host specificity in the predominant microbiota. Within the same individual, profiles were stable in controls but varied notably over time in patients. In controls, the similarity index was remarkably stable (78 +/- 8% mean +/- SD) over a period of 24 months. However, patients showed a steady decline in similarity index versus the initial profile, dropping down to 42 +/- 24% at month 3 of follow-up and to 23 +/- 19% at month 12 (P < 0.001). Biodiversity of the dominant microbiota, as estimated by number of bands, was lower in patients (17 +/- 4) than controls (23 +/- 4, P < 0.01). CONCLUSION: Molecular analysis of fecal bacteria in patients with inactive UC shows low biodiversity and temporal instability.

Fecal excretion of deoxyribonucleic acid in long-term follow-up of patients with inactive ulcerative colitis.

BACKGROUND: We have developed a technique for measuring fecal excretion of human DNA by assuming that luminal desquamation of epithelial and inflammatory cells increases in damaged colonic mucosa. However, the clinical usefulness of this technique in the follow-up of patients with ulcerative colitis has not been established. The aim of this study was to determine the stability of fecal DNA in inactive ulcerative colitis and its potential value as an indicator of relapse. METHODS: The 54 patients with clinically quiescent ulcerative colitis in this prospective study were followed for 12 months or until clinical relapse (clinical activity index > 7). Fecal calprotectin concentration was determined by ELISA, and fecal DNA concentration was determined by quantitative PCR. RESULTS: During the year of follow-up, 23 of the 54 patients relapsed, with a median increase in the colitis activity index from 1.0 to 8.0 (P < 0.01). Median fecal DNA remained unchanged in patients with stable, inactive colitis, ranging from 6.8 copies/microg at inclusion to 1.7 copies/microg at the end of follow-up. Fecal calprotectin level also was unchanged, ranging from 414.0 microg/g at inclusion to 128.9 microg/g at the end of follow-up. In contrast, fecal DNA concentration increased significantly in patients who relapsed (259.0 versus 3.9 copies/microg at entry; P < 0.01). Similar increases in relapsing patients were also observed with fecal calprotectin. ROC curve analysis to assess the accuracy of fecal DNA and calprotectin in detecting relapses during follow-up yielded similar results. CONCLUSIONS: Fecal DNA concentration remained stable in patients with inactive ulcerative colitis but increased significantly with relapses. Determining fecal DNA concentration may be a new objective instrument to use in the follow-up of patients.