Eficacia de la cooximetría y del consejo mínimo antitabaco en pacientes fumadores trasplantados renales

[Resumen] OBJETIVO Determinar la eficacia de la medición del mon6xido de carbono exhalado (CO) por cooximetría junto con el consejo breve para dejar de fumar a los 12 meses en comparación a un consejo breve aislado en pacientes trasplantados renales fumadores, en fase de precontemplación, contemplación o preparación, en relación a: a) Consumo de tabaco autodeclarado b) Tasas de abandono del tabaco c) Niveles de monóxido de carbono en aire exhalado (CO) por cooximetría d) Test de cotinina en orina negativos e) Grado de dependencia de la nicotina (test de Fagerstrom) f) Motivación al cambio (Etapas Prochaska, DiClemente) g) Motivación para dejar de fumar (test de Richmond) MATERIAL Y MÉTODOS Ámbito: Servicio de Nefrología del Complejo Hospitalario Universitario A Coruña (CHUAC). Período de estudio: Enero2012 - Diciembre2015. Típo de estudio: Ensayo cI [nico aleatorizado, controlado y abierto con evaluación ciega. Criterios de inclusión/exclusión: Adultos (>18años), trasplantados renales con injerto funcionante, fumadores en etapa de precontemplación, contemplación o preparación que den su consentimiento para participar. Intervención: medición de monóxido de carbono (CO) exhalado junto con el consejo breve para dejar de fumar en comparación con consejo breve aislado. Tamaño muestral: Grupo de intervención(n=56), grupo control(n=56) (a=O.05; ~=O.20; diferencia a detectar 13%). Mediciones: Características socio demográficas, factores de riesgo cardiovascular, información autodeelarada del hábito tabáquico, nivel de dependencia (Test de Fagerstrom), fase de abandono (Prochazka y Di Clemente), motivación para dejar de fumar (Test de Richmond), test de cotinina en orina y monóxido de carbono (CO) exhalado por cooximetría. Análisis estadístico Se comparó la tasa de respuesta de los pacientes en 105 dos brazos de estudio mediante un análisis bivariado y multivariante de regresión logística. Se calculó la relevancia el ínica mediante el cálculo del riesgo relativo (RR), reducción relativa del riesgo (RRR), reducción absoluta del riesgo (RAR) Y número necesario de pacientes a tratar para reducir un evento (NNT). RESULTADOS Se han objetivado diferencias significativas a los 12 meses entre el grupo de intervención Y el grupo control en el monóxido de carbono (CO) exhalado por cooximetría (ppm) (6.1±6.8 vs. 9.7±10.2 ppm; p=O.028). Así como en carboxihemoglobina exhalada por cooximetría (% COHb) (1.2±1.2 vs. 2.0±2.4 %; p=O.039). Los valores de cotinina en orina positivos han sido también estadísticamente diferentes al final del estudio entre el grupo de intervención Y el grupo control. En el grupo de intervención la prevalencia de positivos ha sido del 53.4% y en el grupo control del 74.2%. También se han objetivado diferencias estad ísticamente significativas entre el grupo intervención y el grupo control en diferentes momentos en el seguimiento en relación a motivación al cambio (estadios de Prochaska y DiClemente). A los 12 meses, en el grupo de intervención se encuentran más pacientes en estado de abandono del tabaco que en el grupo control (46.6% vs 32.3%). La misma tendencia se objetiva a los 6 meses. No se objetivan diferencias significativas entre ambos grupos en las variables consumo de tabaco autodeelarado (nQ cigarrillos/día), tasa de fumadores (%), dependencia a la nicotina (Test Fagerstrom) Y motivación para dejar de fumar (Test Richmond). Aunque no se objetivan diferencias entre ambos grupos los valores de consumo autodeelarado de tabaco (nQ cigarrillos/día), este valor es discretamente superior en el grupo control que en el grupo intervención a lo largo del seguimiento y la misma tendencia se objetiva en la dependencia a la nicotina (Test Fagerstróm). Existe una alta concordancia entre el consumo de tabaco autodeclarado y el test de cotinina en orina positivo durante el seguimiento, medida por el índice Kappa Los cocientes de probabilidad negativos con valores bajos muestran de cualquier forma que una negación de la exposición al tabaco por parte del paciente no la descarta. Por el contrario, un cociente de probabilidad positivo con valores tan altos como el obtenido a los 6 meses (40.41) Indica que una afirmación positiva prácticamente confirma la exposición. En el análisis multivariado (OR ajustado), tras tener en consideración las variables: edad al inicio del ensayo, consumo autodeclarado de tabaco, dependencia a la nicotina (Test Fagerstróm), motivación para dejar de fumar (Test Richmond), género y grupo se objetiva que las variables que tienen un efecto independiente para predecir positividad son el grupo de asignación al estudio, la motivación para dejar de fumar medida por el test Richmond basalmente y el consumo autodeclarado de tabaco (cigarrillos/día) basal. El estar en el grupo de intervención reduce significativamente el riesgo de test de cotinina en orina positivo (OR 0.39; 95% le: 0.17-0.89); la mayor motivación para dejar de fumar reduce a su vez el riesgo de ser positivo (OR 0.83; 95% le: 0.68-0.99) y el consumo autodeclarado de tabaco (cigarrillos/día) incrementa dicho riesgo (OR 1.09; 95% le: 1.02-1.16), a más cigarrillos de consumo basal mayor riesgo de un resultado positivo. La relevancia clínica de la intervención realizada se ha medido por medio de la confirmación del test de cotinina en orina a lo largo del seguimiento entre ambos grupos. A los 12 meses se objetiva que la intervención reduce un 28% la positividad del test de cotinina en orina en relación al grupo control. Por otra parte, el valor del NNT a los 12 meses, muestra que cada 5 pacientes en los que realizamos una intervención, logramos que uno deje de fumar. CONCLUSIONES La utilización de la cooximetría, en pacientes trasplantados renales fumadores es una intervención clínicamente relevante para reducir la exposición al tabaco.[Resumo] OBXETIVO Determinar a eficaza da medición de monóxido de carbono (CO) exhalado por cooximetría xunto co consello breve para deixar de fumar ós 12 meses en comparación cun consello breve IIlado en pacientes trasplantados renais fumadores, en fase de precontemplación, contemplación ou prepraración, en relación a: a) Consumo de tabaco autodeclarado b) Tasas de abandono do tabaco c) Niveis de monóxido de carbono (CO) en aire exhalado por cooximetría d) Test de cotinina en ouriños negativos e) Grao de dependencia a nicotina (test de Fagerstriim) f) Motivación ó cambio (Etapas Prochaska, DiClemente) g) Motivación para deixar de fumar (test de Richmond) MATERIAL E MFrODOS Ámbito: Servizo de Nefroloxía do Complexo Hospitalario Universitario A Coruña (CHUAC). Periodo do estudo: Xaneiro2012 - Decembro2015. Tipo de estudio: Ensaio clínico aleatorizado, controlado e aberto con avaliación cega. Criterios de inclusión/exclusión: Adultos (>18anos), trasplantados renais con inxerto funcionante, fumadores en etapa de precontemplación, contemplación ou preparación que dean o seu consentemento para participar. Intervención: Medición do monóxido de carbono (CO) exhalado xunto co consello breve para deixar de fumar en comparación cun consello breve illado. Tamaño da mostra: Grupo de intervención(n=56), grupo control(n=S6)(a=O.05; ~=O.20; diferencia a detectar 13%). Medicións: Características sociodemográficas, factores de risco cardiovascular, información autodeelarada do hábito tabáquico, nivel de dependencia á nicotina (Test de Fagerstrom), fase de abandono (Prochazka y Di Clemente), motivación para deixar de fumar (Test de Richmond), test de cotinina en ouriños e monóxido de carbono (Ca) exhalado por cooximetría. Análise estatístico: Comparo use a tasa de res posta dos pacientes nos dous brazos do estudo mediante un análise bivariado e multivariado de regresión loxística. Calculouse a relevanza el ínica mediante o cálculo do risco relativo (RR), reducción relativa del risco (RRR), reducción absoluta do risco (RAR) e número necesario de pacientes a tratar para reducir un evento (NNT). RESULTADOS Obxetiváronse diferenzas significativas ós 12 meses entre o grupo da intervención e o grupo control no monóxido de carbono (Ca) exhalado por cooximetría (ppm) (6.1±6.8 vs. 9.7±10.2 ppm; p=O.028). Así como na carboxihemoglobina exhalada por cooximetría (% COHb) (1.2±1.2 vs. 2.0±2.4 %; p=O.039). Os valores de cotinina en ouriños positivos foron tamén estadísticamente diferentes ó remate do estudo entre o grupo da intervención e o grupo control. No grupo da intervención a prevalenza de positivos foi do 53.4% e no grupo control do 74.2%. Tamén se obxetivaron diferenzas estadísticamente significativas entre o grupo da intervención e o grupo control en diferentes momentos do seguemento en relación á motivación ó cambio (estadios de Prochaska e DiClemente). Ós 12 meses, no grupo da intervención encóntranse máis pacientes no estado de abandono do tabaco que no grupo control (46.6% vs. 32.3%). A mesma tendencia obxetivase ós 6 meses. Non se obxetivan diferenzas significativas entre ambos grupos nas variables consumo de tabaco autodeelarado (nº cigarrillos/d ía), tasa de fumadores (%), dependencia á nicotina (Test Fagerstrom) e motivación para deixar de fumar (Test Richmond). Aínda que non se obxetivan diferenzas entre ambos grupos nos valores de consumo autodeelarado de tabaco (nº cigarrillos/d ía), este valor é discretamente superior no grupo control que no grupo intervención ó longo do seguemento e a mesma tendencia objetivase na dependenza á nicotina (Test Fagerstrom). Existe unha alta concordancia entre o consumo de tabaco autodeclarado e o test de cotinina en ouriños positivo durante o seguemento, medida polo índice Kappa. Os cocientes de probabilidade negativos con valores baixos mostran de calquera forma que unha negación da exposición ó tabaco por parte do paciente non a descarta. Polo contrario, un cociente de probabilidade positivo con valores tan altos como o obtido ós 6 meses (40.41) indica que unha afirmación positiva prácticamente confirma a exposición. No análise multivariado (OR axustado), tras tener en consideración as variables: idade ó inicio do ensaio, consumo autodeclarado de tabaco, dependencia á nicotina (Test Fagerstrtim), motivación para deixar de fumar (Test Richmond), xénero e grupo obxetívase que as variables que teñen un efecto independiente para predecir positividade son o grupo de asignación ó estudo, a motivación para deixar de fumar medida por el test Richmond basal mente e o consumo autodeclarado de tabaco (cigarrillos/día) basal. Estar no grupo da intervención reduce significativamente o risco de test de cotinina en ouriños positivo (OR 0.39; 95% le: 0.17-0.89). A maior motivación para deixar de fumar reduce a súa vez o risco de ser positivo (OR 0.83; 95% le: 0.68-0.99) e o consumo autodeclarado de tabaco (cigarrillos/día) incrementa o dito risco (OR 1.09; 95% le: 1.02-1.16), a máis cigarrillos de consumo basal maior risco dun resultado positivo A relevancia clínica da intervención realizada mediuse por medio da confirmación do test de cotinina en ouri ños ó longo do seguemento entre ambos grupos. Os 12 meses obxetivase que a intervención reduce un 28% a positividade do test de cotinina en ouriños en relación ó grupo control. Por outra parte, o valor do NNT ós 12 meses, mostra que cada 5 pacientes nos que realizamos una intervención, logramos que un deixe de fumar. CONCLUSIÓNS A utilización da cooximetría en pacientes trasplantados renais fumadores, é unha intervención cI ínicamente relevante para reducir a exposición ó tabaco.[Abstract] AIM To determine the efficacy of exhaled carbon monoxide (CO) measurement plus smoking brief advice, in comparison to brief advice, to reduce smoking exposure and smoking behaviour in smoking kidney transplant recipients, in the precontemplation, contemplation or preparation stage of change, in terms of: a) Pattern of tobacco use (self-reported tobacco use) b) Smoking cessation rates c) Carbon monoxide (CO) levels in exhaled air measured by cooximetry d) Negative urine cotinine test e) Nicotine dependence (Fagestréim's test) f) Motivation to stop smoking (Prochaska and DiClemente's Stages of Change Model) g) Motivation to quit smoking (Richmond's test) MATERIAL AND METHODS Scope: Nephrology Department, Complejo Hospitalario Univesitario A Coruña (CHUAC). Study period: January 2012 - December 2015. Type of study: Randomized, controlled, open clinical trial with blind evaluation. Inclusion I exclusion criteria: Adults (>18 years), smoking kidney transplant recipients with a functioning graft, in the precontemplation, contemplation or preparation stage of change, who give their consent to participate. Intervention: Exhaled carbon monoxide (CO) measurement plus brief advice to quit smoking, compared with isolated brief advice. Sample size: Intervention group (n=56), control group (n=56) (a = 0.05, f3 = 0.20; minimally clínical relevant difference 13%). Measurements: Socio-demographic characteristics, cardiovascular risk factors, selfreported tobacco use, level of dependence (Fagerstrom's Test), motivation to quit smoking (Prochazka and Di Clemente's stage of change), motivation to stop smoking (Richmond's test), cotinine urine test and exhaled carbon monoxide (CO), measured by co-oximetry. Statistical analysis: Patients' response in both study arms was compared using a bivariate and multivariate logistic regression analysis. Clinical relevance was calculated by means of the relative risk (RR), relative risk reduction (RRR), absolute risk reduction (ARR) and the number needed to treat to reduce an event (NNT). RESUlTS At 12 months of follow-up, significant differences were found in exhaled CO measurements between the intervention and the control group (6.1 ± 6.8 vs. 10.2 ± 9.7 ppm; p=0.028). Carboxyhemoglobin (% COHb) levels resulted also significantly lower in the intervention group (1.2 ± 1.2 vs. 2.0 ± 2.4%; p=0.039). Furthermore, percentage of patients with a positive cotinine urine at the end of the study was lower in the intervention than in the control arm (53.4% vs. 74.2%). At different points in the follow-up, significant differences were also found between both groups of patients regarding their motivation to quit smoking, according with the Prochaska and OiClemente's stages of change. Therefore, at 12 months, there were more patients in the abandonment stage in the intervention than in the control group (46.6% vs. 32.3%). The same trend was observed at 6 months of follow-up. No significant differences between both groups were determined in terms of selfreported tobacco use (number of cigarettes/day), smoking rate, nicotine dependence (Fagerstrom's test) nor in the motivation to stop smoking (Richmond's test). However, the trend was that patients in the intervention arm showed lower self-reported tobacco use and lower nicotine dependence during all the follow-up. Agreement between self-reported tobacco use and urine cotinine test results was high, according to Kappa index results. However, low negative likelihood ratios indicate that a negative self-report does not rule out the smoking status. Conversely, a high positive likelihood ratio as that obtained at 6 months (40.41) indicates that a positive self-report almost confirm the exposure. In the multivariate analysis (adjusted OR), after taking into account the variables: age at baseline, self-reported tobacco use, nicotine dependence (Fagerstrom's test), motivation to quit smoking (Richmond's test), gender and treatment group; variables with an independent effect to predict a positive cotinine urlne test were: being assigned to the intervention group, motivation to quit smoking at baseline and baseline self-declared tobacco use. Being in the intervention group significantly reduces the risk of a positive cotinine urine test (OR=0.39; 95% CI: 0.17 to 0.89). The highest motivation to quit in turn reduces the risk of a positive result (OR=0.83; 95% CI: 0.68 to 0.99), whilst the self-declared tobacco consumption (cigarettes/day) increases the risk (OR 1.09; 95% CI: 1.02-1.16). Clinical relevance of the intervention has been measured with regard to a negative cotinine urine test during the follow-up. At 12 months, the intervention reduces by 28% the probability or a positive urine test, in comparison with the control group. Moreover, the NNT at 12 months shows that in 5 patients where we do an intervention, get one stop smoking. CONCLUSIONS The use of cooximetry, in smoking kidney transplant recipients, is a clinically relevant intervention to reduce tobacco exposure

Sexual Dysfunction in Ostomized Patients: A Systematized Review

[Abstract] The impact of an ostomy has a negative influence on sexuality. Healthcare professionals focus the care on surgery, and consider the sexual life is little relevant to the patient recovery. The aim of this systematized review is to give visibility to the sexual problems that ostomy patients have, to know what kind of sexual dysfunction occurs in this patients, to give information to the nursing staff about sexual disturbances and to recommend some resources to restart sexual activity. The research was conducted following de PRISMA guidelines and performed in several databases. Twelve papers were used to perform the systematized review. After ostomy, sexual dysfunction is different in men and women. It is related by the psychological aspects (low self-esteem, body image deterioration, etc.), the physical aspects (type of resection, complications, etc.) and the acceptance by the partner. A personalized sexual education focused on sexual problems that appear in ostomy patients is necessary to implement. In this way, adequate support, information and resources before and after surgery could be given for both, patients and their partners

Psycho-emotional distress in children and adolescents in relation to COVID-19 confinement and pandemic: a systematized review

Review[Abstract] A stressor such as a pandemic is a trigger to focus on the study of the psycho-emotional impact on children and adolescents from a nursing care perspective. The aim of this systematized review was to know the impact of the lockdown and COVID-19 pandemic on children (from 2 to 12 years) and adolescent (from 13 to 18 years) in relation to daily routines, as well as the most frequent psycho-emotional manifestations. The research was carried out following PRISMA guidelines and was performed using several databases (PubMed, Scopus and Cochrane). The search was focused on children and adolescent population between 2020 and 2021.The literature search was from November to December 2021. Sixteen articles were used to perform the systematized review. A disruption in daily routines and an increase in psycho-emotional manifestations have been observed in young people, which is understood as a worsening of their psycho-emotional integrity. Higher levels of anxiety and depression in adolescents and hyperactivity and dependence disorders in the children have also been reported. In conclusion, children and adolescents have been affected in the psycho-emotional sphere in the same way as adults, therefore, it is necessary to know the presenting characteristics of this group of people in order to be able to establish an effective nursing approach and help preserve the mental integrity, as well as promote resilience

Pain assessment and management in the newborn: a systematized review

[Abstract] Background: Neonatal pain has been underdiagnosed due to several false beliefs. Aim: To determine the status of neonatal pain in newborns who are admitted to intensive care units. Methods: Different databases were searched. Literature reviews and research reports conducted in newborns that were written in English, Spanish, or Portuguese, published between 2010 and 2020, and having free access to the full text were selected. A total of 135 articles were found, and 18 articles were finally reviewed. Results: Newborns are exposed to numerous painful procedures. In order to assess their pain levels, several scales have been used, although they are sometimes not correctly interpreted. In terms of pain management, the nursing team plays a very important role based mainly on both pharmacological and non-pharmacological approaches. Conclusion: Nursing staff members must be well trained in order to identify pain and to interpret the scales correctly. Besides, they have an important role in performing non-pharmacological procedures for pain management

Concordance between Pressure Platform and Pedigraph

[Abstract] Objectives: Determine the concordance between two methods of obtaining the plantar footprint (pedigraph and pressure platform). Methods: A descriptive, cross-sectional, observational study of prevalence was carried out in the social center of Cariño (Coruña), Spain (n = 65 participants). Older people without amputations or the presence of dysmetria were included. The variables studied were: sociodemographic (age, sex), anthropometric (body mass index) and footprint measurement variables. These measurements were made by obtaining the plantar footprint using two methods: pedigraph and pressure platform. Results: The mean age of the sample was 37.42 ± 15.05 years, with a predominance of the female gender (61.54%). Positive linear correlation between pedigraph and platform was observed in both feet in the Chippaux and Staheli indices (correlation coefficient > 0.3, p < 0.001 in each comparison). The reliability was good or moderate in relation with the Chippaux and Staheli index. Slightly lower coefficients were observed in the dimensions of the foot. Conclusions: A positive linear correlation between pedigraph and platform was observed in both feet in the Chippaux and Staheli indices. Significant differences were observed between pedigraph and platform in relation to the width and length of the foot. It is probably due to the fact that the pressure platform provides more exhaustive, detailed and accurate information of the foot. Methods: A descriptive, cross-sectional, observational study of prevalence was carried out in the social center of Cariño (Coruña), Spain (n = 65 participants). Older people without amputations or the presence of dysmetria were included. The variables studied were: sociodemographic (age, sex), anthropometric (body mass index) and footprint measurement variables. These measurements were made by obtaining the plantar footprint using two methods: pedigraph and pressure platform. Results: The mean age of the sample was 37.42 ± 15.05 years, with a predominance of the female gender (61.54%). Positive linear correlation between pedigraph and platform was observed in both feet in the Chippaux and Staheli indices (correlation coefficient > 0.3, p < 0.001 in each comparison). The reliability was good or moderate in relation with the Chippaux and Staheli index. Slightly lower coefficients were observed in the dimensions of the foot. Conclusions: A positive linear correlation between pedigraph and platform was observed in both feet in the Chippaux and Staheli indices. Significant differences were observed between pedigraph and platform in relation to the width and length of the foot. It is probably due to the fact that the pressure platform provides more exhaustive, detailed and accurate information of the foot

Incidence of COVID-19 in Children and Young People Who Play Federated Football

[Abstract] Aim: To determine the incidence of SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) infection in children and young people who play federated football. Methods: Prospective study, from October 2020 to January 2021, in players aged 4 to 19 years from federated football clubs in Galicia, Spain (N = 23,845). Outbreaks and cases of SARS-CoV-2 infection were recorded. The cumulative incidence was compared with the incidence registered in Galicia in the same age range. Results: The cumulative incidence was 29.8 cases per 10,000 licenses in 4 months, lower than the incidence registered in the general population for all ages and both sexes (283.7 per 10,000 inhabitants; rate ratio = 9.5). It was higher in January (40.7 per 10,000), coinciding with the population peak. More cases were registered in futsal (42.9 vs 27.5 per 10,000) and competitions with periodic screenings (127.4 vs 9.1 per 10,000). There were 2 outbreaks in 2389 teams (0.08%). Conclusion: The results support the safety of football practice in children and young people with prevention protocols

Diagnostic and treatment delay, quality of life and satisfaction with care in colorectal cancer patients: a study protocol

[Abstract] Background. Due to recent improvements in colorectal cancer survival, patient-reported outcomes, including health-related quality of life and satisfaction with care, have become well-established endpoints to determine the impact of the disease on the lives of patients. The aim of this study is to determine prospectively, in a cohort of colorectal cancer incident cases: a) health-related quality of life, b) satisfaction with hospital-based care, and c) functional status. A secondary objective is to determine whether diagnostic/therapeutic delay influence quality of life or patients’ satisfaction levels. Methods/design. Single-centre prospective follow-up study of colorectal cancer patients diagnosed during the period 2011–2012 (n = 375). This project was approved by the corresponding ethics review board, and informed consent is obtained from each patient. After diagnosis, patients are interviewed by a trained nurse, obtaining information on sociodemographic characteristics, family history of cancer, first symptoms, symptom perception and reaction to early symptoms. Quality of life is assessed with the EORTC QLQ-C30 and QLQ- CR29 questionnaires, and patients’ satisfaction with care is determined using the EORTC IN-PATSAT32. Functional status is measured with the Karnofsky Performance Status Scale. Clinical records are also reviewed to collect information on comorbidity, tumour characteristics, treatment, hospital consultations and exploratory procedures. Symptoms-to-diagnosis interval is defined as the time from the date of first symptoms until the cytohistological confirmation of cancer. Treatment delay is defined as the time between diagnosis and surgical treatment. All the patients will be followed-up for a maximum of 2 years. For survivors, assessments will be re-evaluated at one and two years after the diagnosis. Multiple linear/logistic regression models will be used to identify variables associated with the patients’ functional status, quality of life and satisfaction with care score. Changes in quality of life over time will be analysed with linear mixed-effects regression models. Discussion. The results will provide a deeper understanding of the impact of colorectal cancer from a more patient-centred approach, allowing us to identify groups of patients in need of additional attention, as well as areas for improvement. Special attention will be given to the relationship between diagnostic/therapeutic delay and patients’ quality of life and satisfaction with the care received.Instituto de Salud Carlos III; PI10/02285Galicia. Consellería de Economía e Industsria; 10CSA916052P

Characterisation of Long-Term Cancer Survivors and Application of Statistical Cure Models: A Protocol for an Observational Follow-up Study in Patients With Colorectal Cancer

Study protocol[Abstract] Background: Improved colorectal cancer (CRC) survival rates have been reported over the last years, with more than half of these patients surviving more than 5 years after the initial diagnosis. Better understanding these so-called long-term survivors could be very useful to further improve their prognosis as well as to detect other problems that may cause a significant deterioration in their health-related quality of life (HRQoL). Cure models provide novel statistical tools to better estimate the long-term survival rate for cancer and to identify characteristics that are differentially associated with a short or long-term prognosis. The aim of this study will be to investigate the long-term prognosis of CRC patients, characterise long-term CRC survivors and their HRQoL, and demonstrate the utility of statistical cure models to analyse survival and other associated factors in these patients. Methods: This is a single-centre, ambispective, observational follow-up study in a cohort of n = 1945 patients with CRC diagnosed between 2006 and 2013. A HRQoL sub-study will be performed in the survivors of a subset of n = 485 CRC patients for which baseline HRQoL data from the time of their diagnosis is already available. Information obtained from interviews and the clinical records for each patient in the cohort is already available in a computerised database from previous studies. This data includes sociodemographic characteristics, family history of cancer, comorbidities, perceived symptoms, tumour characteristics at diagnosis, type of treatment, and diagnosis and treatment delay intervals. For the follow-up, information regarding local recurrences, development of metastases, new tumours, and mortality will be updated using hospital records. The HRQoL for long-term survivors will be assessed with the EORTC QLQ-C30 and QLQ-CR29 questionnaires. An analysis of global and specific survival (competitive risk models) will be performed. Relative survival will be estimated and mixture cure models will be applied. Finally, HRQoL will be analysed through multivariate regression models. Discussion: We expect the results from this study to help us to more accurately determine the long-term survival of CRC, identify the needs and clinical situation of long-term CRC survivors, and could be used to propose new models of care for the follow-up of CRC patients.This project received a research grant from the Carlos III Institute of Health (Ministry of Science, Innovation and Universities, Spain; reference PI18/01676) which was co-funded with European Union ERDF funds (European Regional Development Fund, “A way to make Europe”). The study has undergone peer-review by the funding body. In addition, the study is also partially supported by the Galician Network for Colorectal Cancer Research (REGICC)

Incidence of cardiovascular events and associated risk factors in kidney transplant patients: a competing risks survival analysis

[Abstract] Background: The high prevalence of cardiovascular risk factors among the renal transplant population accounts for increased mortality. The aim of this study is to determine the incidence of cardiovascular events and factors associated with cardiovascular events in these patients. Methods: An observational ambispective follow-up study of renal transplant recipients (n = 2029) in the health district of A Coruña (Spain) during the period 1981-2011 was completed. Competing risk survival analysis methods were applied to estimate the cumulative incidence of developing cardiovascular events over time and to identify which characteristics were associated with the risk of these events. Post-transplant cardiovascular events are defined as the presence of myocardial infarction, invasive coronary artery therapy, cerebral vascular events, new-onset angina, congestive heart failure, rhythm disturbances, peripheral vascular disease and cardiovascular disease and death. The cause of death was identified through the medical history and death certificate using ICD9 (390-459, except: 427.5, 435, 446, 459.0). Results: The mean age of patients at the time of transplantation was 47.0 ± 14.2 years; 62% were male. 16.5% had suffered some cardiovascular disease prior to transplantation and 9.7% had suffered a cardiovascular event. The mean follow-up period for the patients with cardiovascular event was 3.5 ± 4.3 years. Applying competing risk methodology, it was observed that the accumulated incidence of the event was 5.0% one year after transplantation, 8.1% after five years, and 11.9% after ten years. After applying multivariate models, the variables with an independent effect for predicting cardiovascular events are: male sex, age of recipient, previous cardiovascular disorders, pre-transplant smoking and post-transplant diabetes. Conclusions: This study makes it possible to determine in kidney transplant patients, taking into account competitive events, the incidence of post-transplant cardiovascular events and the risk factors of these events. Modifiable risk factors are identified, owing to which, changes in said factors would have a bearing of the incidence of events

A randomized clinical trial to determine the effectiveness of CO-oximetry and anti-smoking brief advice in a cohort of kidney transplant patients who smoke: study protocol for a randomized controlled trial

Randomized controlled trial[Abstract]Background: The cardiovascular risk in renal transplant patients is increased in patients who continue to smoke after transplantation. The aim of the study is to measure the effectiveness of exhaled carbon monoxide (CO) measurement plus brief advisory sessions, in comparison to brief advice, to reduce smoking exposure and smoking behavior in kidney transplant recipients who smoke. The effectiveness will be measured by: (1) abandonment of smoking, (2) increase in motivation to stop smoking, and (3) reduction in the number of cigarettes smoked per day. Design: a randomized, controlled, open clinical trial with blinded evaluation. Scope: A Coruña Hospital (Spain), reference to renal transplantation in the period 2012-2015. Inclusion criteria: renal transplant patients who smoke in the precontemplation, contemplation or preparation stages according to the Prochaska and DiClemente's Stages of Change model, and who give their consent to participate. Exclusion criteria: smokers attempting to stop smoking, patients with terminal illness or mental disability that prevents them from participating. Randomization: patients will be randomized to the control group (brief advisory session) or the intervention group (brief advisory session plus measuring exhaled CO). The sample target size is n = 112, with 56 patients in each group. Allowing for up to 10 % loss to follow-up, this would provide 80 % power to detect a 13 % difference in attempting to give up smoking outcomes at a two-tailed significance level of 5 %. Measurements: sociodemographic characteristics, cardiovascular risk factors, treatment, rejection episodes, infections, self-reported smoking habit, drug use, level of dependence (the Fagerström test), stage of change (Prochaska and DiClemente's Stages of Change model), and motivation to giving up smoking (the Richmond test). Response: the effectiveness will be evaluated every 3, 6, 9 and 12 months as: pattern of tobacco use (self-reported tobacco use), smoking cessation rates, carbon monoxide (CO) levels in exhaled air measured by CO-oximetry, urinary cotinine tests, nicotine dependence (Fagerström test), motivational stages of change (Prochaska and DiClemente's stages) and motivation to stop smoking (the Richmond test). Analysis: descriptive statistics and linear/logistic multiple regression models will be performed. Clinical relevance will be measured as relative risk reduction, absolute risk reduction and the number needed to treat. Ethics: informed consent of the patients and Ethical Review Board was obtained (code 2011/061). Discussion: Tobacco is a modifiable risk factor that increase the risk of morbidity and mortality in kidney transplant recipients. If effectiveness of CO-oximetry is confirmed to reduce tobacco exposure, we would have an intervention that is easy to use, low cost and with great implications about cardiovascular risk prevention in these patients.Instituto de Salud Carlos III; PI11/0135