Effect of Aromatic Herbs and Spices Present in the Mediterranean Diet on the Glycemic Profile in Type 2 Diabetes Subjects: A Systematic Review and Meta-Analysis.

BACKGROUND: The Mediterranean Diet (MedDiet) is the dietary pattern par excellence for managing and preventing metabolic diseases, such as Type 2 Diabetes (T2DM). The MedDiet incorporates spices and aromatic herbs, which are abundant sources of bioactive compounds. The aim of this study was to analyze the effect of all aromatic herbs and spices included in the MedDiet, such as black cumin, clove, parsley, saffron, thyme, ginger, black pepper, rosemary, turmeric, basil, oregano, and cinnamon, on the glycemic profile in T2DM subjects. METHODS: PubMed, Web of Science, and Scopus databases were searched for interventional studies investigating the effect of these aromatic herbs and spices on the glycemic profile in T2DM subjects. RESULTS: This systematic review retrieved 6958 studies, of which 77 were included in the qualitative synthesis and 45 were included in the meta-analysis. Our results showed that cinnamon, turmeric, ginger, black cumin, and saffron significantly improved the fasting glucose levels in T2DM subjects. The most significant decreases in fasting glucose were achieved after supplementation with black cumin, followed by cinnamon and ginger, which achieved a decrease of between 27 and 17 mg/dL. CONCLUSIONS: Only ginger and black cumin reported a significant improvement in glycated hemoglobin, and only cinnamon and ginger showed a significant decrease in insulin.

Use of health services and medication use, new comorbidities, and mortality in patients with chronic diseases who did not contract COVID-19 during the first year of the pandemic: a retrospective study and comparison by sex.

BACKGROUND: The restrictions introduced to stop the spread of the COVID-19 virus have also had a direct impact on people with chronic diseases and especially on diseases to which lifestyles are relevant in their control and management, such as diabetes, hypertension, chronic obstructive pulmonary disease (COPD), etc. The purpose of this paper is to conduct a longitudinal analysis of new comorbidities, mortality, medication use, and the use of health resources in patients with chronic diseases who did not contract COVID-19, comparing the six months before the strict lockdown to the 12 months following the end of the strict lockdown. METHOD: An observational real world data pre-post study of 668,974 people was undertaken. The patients studied were over 16 years of age, had been receiving care from the Aragon Health Service (Northeastern Spain), were diagnosed with one or more chronic diseases, and had not contracted COVID-19. Sociodemographic, comorbidity, pharmacological and health resource use variables were collected during the six months before the onset of the lockdown and during the six and 12 months following the end of the lockdown. The comparisons by sex were carried out using a Student T-test or chi-squared test to analyse differences. RESULTS: Dyslipidaemia (42.1%) followed by hypertension (35.1%) and anxiety and depression (34.6%) were the most prevalent chronic diseases among the study population. 78.% of patients had between one and four chronic illnesses. There was a decrease in new diagnoses of other chronic comorbidities in this population and a decrease in medications prescribed and the use of health services.  Although women received more diagnoses of chronic diseases, the number of medications dispensed was lower, but the use of health services was higher. These figures were maintained throughout the pandemic. CONCLUSION: Our results suggest an underdiagnosis of new chronic comorbidities and a decrease in mortality rates from causes unrelated to COVID-19 due to the closure of health centres in Aragón (Spain) during the lockdown. This trend was exacerbated in women. The underdiagnosis of new chronic comorbidities during confinement can cause the disease to worsen, with the consequent increase in symptoms and the worsening of chronic pathologies in patients with a severe evolution.

Social support as a mediator in the relationship between technostress or academic stress and health: analysis by gender among university students.

Introduction: This research aims to study the role of social support as a mediator in the relationship between technostress or academic stress and health in university students. Methods: A descriptive, quantitative cross-sectional study has been carried out through a self-reported survey answered by 389 students during March and April 2022. The current level of health was the outcome variable. Technostress and academic stress were the criterion variables. Perceived social support was the mediator variable. The sociodemographic variables and ICT use at the educational level were the independent variables. Results: Women have higher levels of technostress and academic stress than men. Social support significantly and positively mediates the relationship between academic stress and self-perceived health in men. Discussion: There is a clear need to develop new social management strategies that assist students in developing stable and long-lasting social networks, which can reduce stress during the student period and provide personal tools for later working life.

The impact of the COVID-19 pandemic in diabetes and dyslipidemia management in a Spanish region: a retrospective study of the Aragon population.

Introduction: Previous research has indicated that the COVID-19 outbreak had a negative impact on the diagnosis and management of cardiometabolic diseases. Our aim was to analyze the impact of the COVID-19 pandemic on the management of dyslipidemia and type 2 diabetes (T2D) in the Aragon region of Spain. Methods: We conducted an observational retrospective study, which included data from all patients diagnosed with active T2D or dyslipidemia in Aragon during 2019-2021. Data was collected from the BIGAN platform, a big database that includes all healthcare data from the Aragon population. Clinical, biochemical, and pharmacological prescription information was obtained for each patient and for each year. Results: Out of the total population of 1,330,000 in the Aragon region, 90,000 subjects were diagnosed with T2D each year, resulting in a prevalence of approximately 7%. The COVID-19 pandemic resulted in a decrease in the prevalence of this disease and a lower incidence during the year 2020. In addition, patients with T2D experienced a deterioration of their glucose profile, which led to an increase in the number of patients requiring pharmacological therapy. The prevalence of dyslipidemia was approximately 23.5% in both 2019 and 2020 and increased to 24.5% in 2021. Despite the worsening of the anthropometric profile, the lipid profile improved significantly throughout 2020 and 2021 compared to 2019. Moreover, the number of active pharmacological prescriptions increased significantly in 2021. Discussion: Our findings suggest that the overload of the health system caused by the COVID-19 pandemic has resulted in an underdiagnosis of T2D. Moreover, patients with T2D experienced a worsening of their glycemic profile, an increase in their pharmacological requirements, and lower performance of their analytical determinations. Dyslipidemic subjects improved their lipid profile although the value of lipid profile determination decreased between 2020 and 2021.

Improvement in the Management of Oral Anticoagulation in Patients with Atrial Fibrillation in Primary Health Care.

(1) Background: Evaluation and improvement of the management of patients with atrial fibrillation in treatment with oral anticoagulants from primary health care. (2) Methods: prospective quasi-experimental study, conducted on 385 patients assisted with Atrial Fibrillation (AF) at the Las Fuentes Norte Health Center, before and after the implementation of actions to improve oral anticoagulants management from October 2015 to July 2017. (3) Results: The ACO-ZAR I study revealed that the population with AF presents a global prevalence of 1.7%, an indication of oral anticoagulants of 92.1%, undertreatment of 24%, suboptimal control of vitamin K antagonists of 43%, use of antiaggregant as primary prevention of 13.42%, and primary health care monitoring of 34%. The implementation of activities aimed at improving the management of oral anticoagulants in the ACO-ZAR II study achieves a reduction in undertreatment up to 16%, in the use of antiaggregant up to 9%, and in suboptimal control up to 30%, as well as an increase in control from primary health care up to 69.2% and of the penetrance of direct oral anticoagulants up to 28%. (4) Conclusions: In conclusion, the application of activities aimed at optimizing the management of oral anticoagulants in health center patients allowed the improvement of risk assessment and registration, undertreatment, use of antiaggregant, suboptimal control of vitamin K antagonists, control by primary health care center, and the penetrance of direct oral anticoagulants.

Capacidad de respuesta del sistema de salud en atención primaria valorada por pacientes con enfermedades crónicas / Evaluation of health center's primary care responsiveness by patients with chronic illnesses

Objetivo: Evaluar la capacidad de respuesta del sistema de salud percibida por pacientes crónicos de atención primaria, así como los factores asociados a esa percepción. Método: Estudio transversal basado en entrevistas a pacientes mayores de 18 años diagnosticados de al menos una enfermedad crónica que visitaron los centros de atención primaria durante junio y julio de 2015 en una zona básica de Salud de La Rioja. El resultado fue el índice de respuesta y los factores potencialmente relacionados incluyeron características sociodemográficas y de salud. Entrevistadores capacitados realizaron el cuestionario breve en español de la encuesta multipaís de la Organización Mundial de la Salud con 403 participantes. Se realizaron estadística descriptiva y regresión logística bivariable y multivariable.Resultados: El 87,10% de los participantes consideró buena la respuesta general. Los dominios que obtuvieron las puntuaciones más altas fueron confidencialidad (99,3%), dignidad (98,3%) y comunicación (97,3%). Los peor evaluados fueron atención rápida (38,6%) y calidad de los servicios básicos (31,8%). La clase social baja fue el factor más importante asociado a la capacidad de respuesta, concretamente con la autonomía y la atención rápida. Sexo, educación y ocupación estuvieron relacionados con comunicación, y los pacientes con peor salud percibida valoraron peor la respuesta general. Los dominios considerados más importantes fueron dignidad (33,5%) y atención rápida (30,5%). Conclusiones: Los dominios mejor evaluados fueron los relacionados con el respeto a las personas. La atención rápida tiene una baja valoración, pero una gran importancia, y por lo tanto requiere una acción prioritaria. (AU)

Objective: To evaluate the health systems’ response capacity according to the perception of chronic patients, and the factors related to that perception. Method: Source of data: patients diagnosed with at least one chronic disease who visited primary care centers during June and July 2015 in a basic health area of La Rioja. Design: cross-sectional descriptive study based on interviews to over 18s who visited primary care centers. The dependent variable was the health systems’ response capacity and independent variables were sociodemographic and health related. In order to collect data, trained interviewers conducted a short questionnaire in Spanish from the World Health Organization Multi-country Survey Study with 403 subjects. Descriptive statistics, bivariate and multivariate logistic regression were performed. Results: The overall health systems’ response capacity was considered good by 87.10%. The domains that scored highest were: confidentiality (99.3%), dignity (98.3%) and communication (97.3%). Those evaluated worst were: rapid service (38,6%) and quality of basic services (31.8%). Low social class was the most important factor associated with the responsiveness, mainly with autonomy and rapid service. Sex, educational level, and occupation were related to communication domain, and patients with worse perceived health rated the general response worse. The domains considered most important were dignity (33.5%) and rapid service (30.5%). Conclusions: The domains best evaluated were those related to respect for people. Rapid service has a low health systems’ response capacity, but a high importance, and therefore requires priority action. (AU)

Long-term Effectiveness of a Smartphone App Combined With a Smart Band on Weight Loss, Physical Activity, and Caloric Intake in a Population With Overweight and Obesity (Evident 3 Study): Randomized Controlled Trial.

BACKGROUND: Multicomponent mobile health approaches can improve lifestyle intervention results, although little is known about their long-term effectiveness. OBJECTIVE: This study aims to evaluate the long-term effectiveness (12 months) of a multicomponent mobile health intervention-combining a smartphone app, an activity tracker wristband, and brief counseling, compared with a brief counseling group only-on weight loss and improving body composition, physical activity, and caloric intake in Spanish sedentary adults with overweight or obesity. METHODS: We conducted a randomized controlled, multicenter clinical trial (Evident 3). A total of 650 participants were recruited from 5 primary care centers, with 318 participants in the intervention group (IG) and 332 in the control group (CG). All participants were briefly counseled about a healthy diet and physical activity at the baseline visit. For the 3-month intervention period, the IG received training to use the app to promote healthy lifestyles and the smart band (Mi Band 2, Xiaomi). All measurements were performed at baseline and at 3 and 12 months. Physical activity was measured using the International Physical Activity Questionnaire-Short Form. Nutritional habits were assessed using the Food Frequency Questionnaire and Adherence to Mediterranean diet questionnaire. RESULTS: Of the 650 participants included, 563 (86.6%) completed the 3-month visit and 443 (68.2%) completed the 12-month visit. After 12 months, the IG showed net differences in weight (-0.26, 95% CI -1.21 to 0.70 kg; P=.02), BMI (-0.06, 95% CI -0.41 to 0.28 points; P=.01), waist-height ratio (-0.25, 95% CI -0.94 to 0.44; P=.03), body adiposity index (-0.33, 95% CI -0.77 to 0.11; P=.03), waist circumference (-0.48, 95% CI -1.62 to 0.66 cm, P=.04) and hip circumference (-0.69, 95% CI -1.62 to 0.25 cm; P=.03). Both groups lowered daily caloric intake and increased adherence to the Mediterranean diet, with no differences between the groups. The IG increased light physical activity time (32.6, 95% CI -30.3 to 95.04 min/week; P=.02) compared with the CG. Analyses by subgroup showed changes in body composition variables in women, people aged >50 years, and married people. CONCLUSIONS: The low-intensity intervention of the Evident 3 study showed, in the IG, benefits in weight loss, some body composition variables, and time spent in light physical activity compared with the CG at 3 months, but once the devices were collected, the downward trend was not maintained at the 12-month follow-up. No differences in nutritional outcomes were observed between the groups. TRIAL REGISTRATION: ClinicalTrials.gov NCT03175614; https://clinicaltrials.gov/ct2/show/NCT03175614. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1097/MD.0000000000009633.

Evaluation of primary care responsiveness by people with mental illness in Spain.

BACKGROUND: The health system responsiveness is a concept developed by the World Health Organization that measures patients' expectations for the non-medical care they receive. The aim of this study is to assess primary care responsiveness as seen by people with mental illness and to analyse the factors associated with poor responsiveness. METHODS: Cross-sectional descriptive study on 426 people with mental illness who had attended primary care consultations at least once in the previous 12 months. The responsiveness of the health system was determined through the short questionnaire "Multi-country Survey Study on Health and Health Systems Responsiveness". Differences in responsiveness by sociodemographic characteristics were compared through the Chi-squared test. Logistic regression identified the factors associated with poor responsiveness. RESULTS: Overall responsiveness was measured as good by 77.4% of patients, being this probability higher in the domains: dignity, confidentiality, and communication. The most valued domains by people with mental illness were prompt attention (42.4%), dignity (30.1%), and communication (17%). Only prompt attention scored high importance and poor responsiveness. In patients with an income lower than 900 euros per month and low level of studies, the probability of poor confidentiality responsiveness was multiplied by 3 and 2.7 respectively. CONCLUSIONS: People with mental illness perceive good responsiveness from primary care in terms of dignity, confidentiality, and communication. Prompt attention, as the domain of greatest importance and worst valuation, should be prioritised through the implementation of organisational measures in health centres to reduce waiting times, especially in urban areas.

[Evaluation of health center's primary care responsiveness by patients with chronic illnesses]. / Capacidad de respuesta del sistema de salud en atención primaria valorada por pacientes con enfermedades crónicas.

OBJECTIVE: To evaluate the health systems' response capacity according to the perception of chronic patients, and the factors related to that perception. METHOD: Source of data: patients diagnosed with at least one chronic disease who visited primary care centers during June and July 2015 in a basic health area of La Rioja. DESIGN: cross-sectional descriptive study based on interviews to over 18s who visited primary care centers. The dependent variable was the health systems' response capacity and independent variables were sociodemographic and health related. In order to collect data, trained interviewers conducted a short questionnaire in Spanish from the World Health Organization Multi-country Survey Study with 403 subjects. Descriptive statistics, bivariate and multivariate logistic regression were performed. RESULTS: The overall health systems' response capacity was considered good by 87.10%. The domains that scored highest were: confidentiality (99.3%), dignity (98.3%) and communication (97.3%). Those evaluated worst were: rapid service (38,6%) and quality of basic services (31.8%). Low social class was the most important factor associated with the responsiveness, mainly with autonomy and rapid service. Sex, educational level, and occupation were related to communication domain, and patients with worse perceived health rated the general response worse. The domains considered most important were dignity (33.5%) and rapid service (30.5%). CONCLUSIONS: The domains best evaluated were those related to respect for people. Rapid service has a low health systems' response capacity, but a high importance, and therefore requires priority action.

Effectiveness of an mHealth Intervention Combining a Smartphone App and Smart Band on Body Composition in an Overweight and Obese Population: Randomized Controlled Trial (EVIDENT 3 Study).

BACKGROUND: Mobile health (mHealth) is currently among the supporting elements that may contribute to an improvement in health markers by helping people adopt healthier lifestyles. mHealth interventions have been widely reported to achieve greater weight loss than other approaches, but their effect on body composition remains unclear. OBJECTIVE: This study aimed to assess the short-term (3 months) effectiveness of a mobile app and a smart band for losing weight and changing body composition in sedentary Spanish adults who are overweight or obese. METHODS: A randomized controlled, multicenter clinical trial was conducted involving the participation of 440 subjects from primary care centers, with 231 subjects in the intervention group (IG; counselling with smartphone app and smart band) and 209 in the control group (CG; counselling only). Both groups were counselled about healthy diet and physical activity. For the 3-month intervention period, the IG was trained to use a smartphone app that involved self-monitoring and tailored feedback, as well as a smart band that recorded daily physical activity (Mi Band 2, Xiaomi). Body composition was measured using the InBody 230 bioimpedance device (InBody Co., Ltd), and physical activity was measured using the International Physical Activity Questionnaire. RESULTS: The mHealth intervention produced a greater loss of body weight (-1.97 kg, 95% CI -2.39 to -1.54) relative to standard counselling at 3 months (-1.13 kg, 95% CI -1.56 to -0.69). Comparing groups, the IG achieved a weight loss of 0.84 kg more than the CG at 3 months. The IG showed a decrease in body fat mass (BFM; -1.84 kg, 95% CI -2.48 to -1.20), percentage of body fat (PBF; -1.22%, 95% CI -1.82% to 0.62%), and BMI (-0.77 kg/m2, 95% CI -0.96 to 0.57). No significant changes were observed in any of these parameters in men; among women, there was a significant decrease in BMI in the IG compared with the CG. When subjects were grouped according to baseline BMI, the overweight group experienced a change in BFM of -1.18 kg (95% CI -2.30 to -0.06) and BMI of -0.47 kg/m2 (95% CI -0.80 to -0.13), whereas the obese group only experienced a change in BMI of -0.53 kg/m2 (95% CI -0.86 to -0.19). When the data were analyzed according to physical activity, the moderate-vigorous physical activity group showed significant changes in BFM of -1.03 kg (95% CI -1.74 to -0.33), PBF of -0.76% (95% CI -1.32% to -0.20%), and BMI of -0.5 kg/m2 (95% CI -0.83 to -0.19). CONCLUSIONS: The results from this multicenter, randomized controlled clinical trial study show that compared with standard counselling alone, adding a self-reported app and a smart band obtained beneficial results in terms of weight loss and a reduction in BFM and PBF in female subjects with a BMI less than 30 kg/m2 and a moderate-vigorous physical activity level. Nevertheless, further studies are needed to ensure that this profile benefits more than others from this intervention and to investigate modifications of this intervention to achieve a global effect. TRIAL REGISTRATION: Clinicaltrials.gov NCT03175614; https://clinicaltrials.gov/ct2/show/NCT03175614. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1097/MD.0000000000009633.

Mental Health Patients' Expectations about the Non-Medical Care They Receive in Primary Care: A Cross-Sectional Descriptive Study.

A health system's responsiveness is the result of patient expectations for the non-medical care they receive. The objective of this study was to assess mental patients' responsiveness to the health system in primary care, as related to the domains of dignity, autonomy, confidentiality, and communication. Data were collected from 215 people over the age of 18 with mental disorders, using the Multi-Country Survey Study (MCSS) developed by the World Health Organization. Of them, 95% reported a good experience regarding the dignity, confidentiality, communication, and autonomy domains. Regarding responsiveness, patients valued the dignity domain as the most important one (25.1%). Among the patients who experienced poor confidentiality, five out of seven earned less than 900 euros per month (Χ2 = 10.8, p = 0.004). Among those who experienced good autonomy, 85 out of 156 belonged to the working social class (90.4%), and among those who valued it as poor (16.1%), the highest proportion was for middle class people (Χ2 = 13.1, p = 0.028). The two students and 87.5% of retirees experienced this dimension as good, and most patients who valued it as poor were unemployed (43.5%) (Χ2 = 13.0, p = 0.011). Patients with a household income higher than 900 euros more frequently valued responsiveness as good, regarding those domains related to communication, with OR = 3.84, 95% CI = 1.05-14.09, and confidentiality, with OR = 10.48, 95% CI = 1.94-56.59. To conclude, as regards responsiveness in primary care, the dignity domain always obtained the best scores by people with mental disorders. Low economic income is related to a poor assessment of confidentiality. Working class patients, students, and retirees value autonomy as good.

Adaptación transcultural y validación del Celiac Dietary Adherence Test. Un cuestionario sencillo para determinar la adherencia a la dieta sin gluten / Transcultural adaptation and validation of the Celiac Dietary Adherence Test. A simple questionnaire to measure adherence to a gluten-free diet

Antecedentes y objetivos: la dieta sin gluten es, hasta la fecha, el único tratamiento para la enfermedad celiaca, pero revisiones sistemáticas indican que sólo entre un 42% y un 91% de los pacientes siguen la dieta estrictamente, dependiendo del método de evaluación y de la definición de adherencia. Es importante contar con herramientas adaptadas transculturalmente que permitan evaluar la adherencia más allá de preguntas autoinformadas o de invasivas analíticas. El objetivo es adaptar transculturalmente y validar el Celiac Dietary Adherence Test de Leffler a la población española en lengua castellana. Métodos: estudio transversal observacional en dos fases: una primera de traducción/retrotraducción por cuatro traductores cualificados y una fase de validación en la que se aplicó el cuestionario a 306 pacientes de Aragón con enfermedad celiaca entre los 12 y los 72 años. Se evaluaron la estructura factorial, la validez de criterio y la consistencia interna. Resultados: la traducción al castellano mantuvo sus 7 ítems con una estructura de 3 factores. a factibilidad fue muy buena con todas las preguntas contestadas y con efectos suelo y techo muy bajos (4,3% y 1%, respectivamente). La correlación de Spearman con las escalas de autoeficacia y calidad de vida y la pregunta autoinformada resultaron estadísticamente significativas (p < 0,01). Aplicando los criterios de este cuestionario se obtuvo una adherencia del 72,3%. Conclusión: la adaptación española del CDAT muestra unas propiedades psicométricas adecuadas, por lo que su uso estaría indicado para el estudio de la adherencia a la dieta sin gluten en entornos clínicos y de investigación (AU)

Background and aims: A gluten-free diet is to date the only treatment available to celiac disease sufferers. However, systematic reviews indicate that, depending on the method of evaluation used, only 42% to 91% of patients adhere to the diet strictly. Transculturally adapted tools that evaluate adherence beyond simple self-informed questions or invasive analyses are, therefore, of importance. The aim is to obtain a Spanish transcultural adaption and validation of Leffler’s Celiac Dietary Adherence Test. Methods: A two-stage observational transversal study: translation and back translation by four qualified translators followed by a validation stage in which the questionnaire was administered to 306 celiac disease patients aged between 12 and 72 years and resident in Aragon. Factorial structure, criteria validity and internal consistency were evaluated. Results: The Spanish version maintained the 7 items in a 3-factor structure. Reliability was very high in all the questions answered and the floor and ceiling effects were very low (4.3% and 1%, respectively). The Spearman correlation with the self-efficacy and life quality scales and the self-informed question were statistically significant (p < 0.01). According to the questionnaire criteria, adherence was 72.3%. Conclusion: The Spanish version of the Celiac Dietary Adherence Test shows appropriate psychometric properties and is, therefore, suitable for studying adherence to a gluten-free diet in clinical and research environments (AU)

Transcultural adaptation and validation of the Celiac Dietary Adherence Test. A simple questionnaire to measure adherence to a gluten-free diet.

BACKGROUND AND AIMS: A gluten-free diet is to date the only treatment available to celiac disease sufferers. However, systematic reviews indicate that, depending on the method of evaluation used, only 42% to 91% of patients adhere to the diet strictly. Transculturally adapted tools that evaluate adherence beyond simple self-informed questions or invasive analyses are, therefore, of importance. The aim is to obtain a Spanish transcultural adaption and validation of Leffler's Celiac Dietary Adherence Test. METHODS: A two-stage observational transversal study: translation and back translation by four qualified translators followed by a validation stage in which the questionnaire was administered to 306 celiac disease patients aged between 12 and 72 years and resident in Aragon. Factorial structure, criteria validity and internal consistency were evaluated. RESULTS: The Spanish version maintained the 7 items in a 3-factor structure. Reliability was very high in all the questions answered and the floor and ceiling effects were very low (4.3% and 1%, respectively). The Spearman correlation with the self-efficacy and life quality scales and the self-informed question were statistically significant (p < 0.01). According to the questionnaire criteria, adherence was 72.3%. CONCLUSION: The Spanish version of the Celiac Dietary Adherence Test shows appropriate psychometric properties and is, therefore, suitable for studying adherence to a gluten-free diet in clinical and research environments.

Diagnosis delay and follow-up strategies in colorectal cancer. Prognosis implications: a study protocol.

BACKGROUND: Controversy exists with regard to the impact that the different components of diagnosis delay may have on the degree of invasion and prognosis in patients with colorectal cancer. The follow-up strategies after treatment also vary considerably. The aims of this study are: a) to determine if the symptoms-to-diagnosis interval and the treatment delay modify the survival of patients with colorectal cancer, and b) to determine if different follow-up strategies are associated with a higher survival rate. METHODS/DESIGN: Multi-centre study with prospective follow-up in five regions in Spain (Galicia, Balearic Islands, Catalonia, Aragón and Valencia) during the period 2010-2012. Incident cases are included with anatomopathological confirmation of colorectal cancer (International Classification of Diseases 9th revision codes 153-154) that formed a part of a previous study (n = 953).At the time of diagnosis, each patient was given a structured interview. Their clinical records will be reviewed during the follow-up period in order to obtain information on the explorations and tests carried out after treatment, and the progress of these patients.Symptoms-to-diagnosis interval is defined as the time calculated from the diagnosis of cancer and the first symptoms attributed to cancer. Treatment delay is defined as the time elapsed between diagnosis and treatment. In non-metastatic patients treated with curative intention, information will be obtained during the follow-up period on consultations performed in the digestive, surgery and oncology departments, as well as the endoscopies, tumour markers and imaging procedures carried out.Local recurrence, development of metastases in the follow-up, appearance of a new tumour and mortality will be included as outcome variables.Actuarial survival analysis with Kaplan-Meier curves, Cox regression and competitive risk survival analysis will be performed. DISCUSSION: This study will make it possible to verify if the different components of delay have an impact on survival rate in colon cancer and rectal cancer. In consequence, this multi-centre study will be able to detect the variability present in the follow-up of patients with colorectal cancer, and if this variability modifies the prognosis. Ideally, this study could determine which follow-up strategies are associated with a better prognosis in colorectal cancer.