Variability between Clarke's angle and Chippaux-Smirak index for the diagnosis of flat feet / Variabilidad entre el ángulo de Clarke y el índice de Chippaux- Smirak para el diagnóstico de pie plano

Abstract Background: The measurements used in diagnosing biomechanical pathologies vary greatly. The aim of this study was to determine the concordance between Clarke's angle and Chippaux-Smirak index, and to determine the validity of Clarke's angle using the Chippaux-Smirak index as a reference. Methods: Observational study in a random population sample (n= 1,002) in A Coruña (Spain). After informed patient consent and ethical review approval, a study was conducted of anthropometric variables, Charlson comorbidity score, and podiatric examination (Clarke's angle and Chippaux-Smirak index). Descriptive analysis and multivariate logistic regression were performed. Results: The prevalence of flat feet, using a podoscope, was 19.0% for the left foot and 18.9% for the right foot, increasing with age. The prevalence of flat feet according to the Chippaux-Smirak index or Clarke's angle increases significantly, reaching 62.0% and 29.7% respectively. The concordance (kappa I) between the indices according to age groups varied between 0.25-0.33 (left foot) and 0.21-0.30 (right foot). The intraclass correlation coefficient (ICC) between the Chippaux-Smirak index and Clarke's angle was -0.445 (left foot) and -0.424 (right foot). After adjusting for age, body mass index (BMI), comorbidity score and gender, the only variable with an independent effect to predict discordance was the BMI (OR= 0.969; 95% CI: 0.940-0.998). Conclusion: There is little concordance between the indices studied for the purpose of diagnosing foot arch pathologies. In turn, Clarke's angle has a limited sensitivity in diagnosing flat feet, using the Chippaux-Smirak index as a reference. This discordance decreases with higher BMI values.

Resumen Introducción: Existe una gran variabilidad en las mediciones para el diagnóstico de la patología biomecánica. El objetivo de este estudio fue determinar la concordancia entre el ángulo de Clarke y el índice de Chippaux-Smirak, para determinar la validez del ángulo de Clarke utilizando como referencia el índice de Chippaux-Smirak. Métodos: Se realizó un estudio observacional en una muestra aleatoriamente seleccionada (n= 1,002) en A Coruña (España). Tras el consentimiento informado del paciente y la aprobación del comité de ética, se estudiaron variables, antropométricas, índice de comorbilidad de Charlson y un examen podológico (ángulo de Clarke, índice de Chippaux-Smirak). Se realizó un estudio descriptivo y un análisis multivariado de regresión logística. Resultados: La prevalencia de pie plano utilizando el podoscopio fue de 19.0% (pie izquierdo) y 18.9% (pie derecho), incrementándose con la edad. La prevalencia de pie plano según el índice Chippaux-Smirak o el ángulo de Clarke se incrementan considerablemente llegando a 62.0% y 29.7%. La concordancia (kappa I) entre los índices según grupos de edad oscila entre 0.25-0.33 (pie izquierdo) y 0.21-0.30 (pie derecho). El coeficiente de correlación intraclase (CCI) entre el índice de Chippaux-Smirak y el ángulo de Clarke es -0.445 (pie izquierdo) y 0.424 (pie derecho). Tras ajustar por edad, índice de masa corporal (IMC), score de comorbilidad y sexo la única variable con un efecto independiente para predecir discordancia es el IMC (OR= 0.969; IC 95%: 0.940-0.998). Conclusiones: La concordancia entre los índices estudiados para el diagnóstico de la patología del arco plantar es reducida. Existe a su vez una reducida sensibilidad del ángulo de Clarke para el diagnóstico de pie plano, utilizando como referencia el índice de Chippaux-Smirak. Esta discordancia disminuye con valores más altos de IMC.

Effect of diagnostic delay on survival in patients with colorectal cancer: a retrospective cohort study.

BACKGROUND: Disparate and contradictory results make studies necessary to investigate in more depth the relationship between diagnostic delay and survival in colorectal cancer (CRC) patients. The aim of this study is to analyse the relationship between the interval from first symptom to diagnosis (SDI) and survival in CRC. METHODS: Retrospective study of n = 942 CRC patients. SDI was calculated as the time from the diagnosis of cancer and the first symptoms of CRC. Cox regression was used to estimate five-year mortality hazard ratios as a function of SDI, adjusting for age and gender. SDI was modelled according to SDI quartiles and as a continuous variable using penalized splines. RESULTS: Median SDI was 3.4 months. SDI was not associated with stage at diagnosis (Stage I = 3.6 months, Stage II-III = 3.4, Stage IV = 3.2; p = 0.728). Shorter SDIs corresponded to patients with abdominal pain (2.8 months), and longer SDIs to patients with muchorrhage (5.2 months) and rectal tenesmus (4.4 months). Adjusting for age and gender, in rectum cancers, patients within the first SDI quartile had lower survival (p = 0.003), while in colon cancer no significant differences were found (p = 0.282). These results do not change after adjusting for TNM stage. The splines regression analysis revealed that, for rectum cancer, 5-year mortality progressively increases for SDIs lower than the median (3.7 months) and decreases as the delay increases until approximately 8 months. In colon cancer, no significant relationship was found between SDI and survival. CONCLUSIONS: Short diagnostic intervals are significantly associated with higher mortality in rectal but not in colon cancers, even though a borderline significant effect is also observed in colon cancer. Longer diagnostic intervals seemed not to be associated with poorer survival. Other factors than diagnostic delay should be taken into account to explain this "waiting-time paradox".

Axillary radiotherapy in conservative surgery for early-stage breast cancer (stage I and II). / Radioterapia axilar en la cirugía conservadora del cáncer de mama en estadio temprano (estadio I y II).

INTRODUCTION: Several clinical studies analyze axillary treatment in women with early-stage breast cancer because of changes in the indication for axillary lymph node dissection. The aim of the study is to analyze the impact of axillary radiotherapy in disease-free and overall survival in women with early breast cancer treated with lumpectomy. METHODS: Retrospective study in women with initial stages of breast carcinoma treated by lumpectomy. A comparative analysis of high-risk women with axillary lymph node involvement who received axillary radiotherapy with the group of women with low risk without radiotherapy was performed. Logistic regression was used to determine factors influencing survival and lymphedema onset. RESULTS: A total of 541 women were included in the study: 384 patients (71%) without axillary lymph node involvement and 157 women (29%) with 1-3 axillary lymph node involvement. Patients with axillary radiotherapy had a higher number of metastatic lymph node compared to non-irradiated (1.6±0.7 vs. 1.4±0.6, P=.02). The group of women with axillary lymph node involvement and radiotherapy showed an overall and disease-free survival at 10 years similar to that obtained in patients without irradiation (89.7% and 77.2%, respectively). 3 lymph nodes involved multiplied by more than 7 times the risk of death (HR=7.20; 95% CI: 1.36 to 38.12). The multivariate analysis showed axillary lymph node dissection as the only variable associated with the development of lymphedema. CONCLUSION: The incidence of axillary relapse on stage I and II breast cancer is rare. In these patients axillary radiotherapy does not improve overall survival, but contributes to regional control in those patients with risk factors.

A randomised crossover trial comparing the Airtraq ® NT, McGrath ® MAC and Macintosh laryngoscopes for nasotracheal intubation of simulated easy and difficult airways in a manikin / Estudo cruzado e randômico comparando os laringoscópios Airtraq ® NT, McGrath ® MAC e Macintosh para intubação nasotraqueal em simulação de via aérea fácil e difícil em manequim

ABSTRACT OBJECTIVE: Several devices can aid nasotracheal intubation when managing difficult airways. The McGrath MAC and Airtraq NT were compared with a Macintosh laryngoscope when studying the performance of anaesthetists with different levels of experience, in a manikin model of easy or difficult airway scenarios. METHODS: Sixty-three anaesthetists were recruited into a randomised trial in which each performed nasotracheal intubation with all laryngoscopes, in both scenarios. The main endpoint was intubation time. Additional endpoints included laryngoscopic view, intubation success, number of optimisation manoeuvres, audible dental clicks and the force applied to the upper airway. RESULTS: Intubation time was significantly shorter using the McGrath MAC in both scenarios and using the Airtraq in the difficult scenario, when compared with the Macintosh laryngoscope. Both devices gave more Cormack and Lehane grade 1 or 2 views than the Macintosh in the difficult scenario (p < 0.001). The McGrath MAC had the best first-attempt success rate (98.4% vs. 96.8% and 95.8%, p < 0.001 for the Airtraq NT and Macintosh laryngoscopes respectively). The number of optimisation manoeuvres, audible dental clicks and subjective assessment of the degree of force applied were significantly lower for indirect laryngoscopes versus the Macintosh laryngoscope (p < 0.001). CONCLUSION: In a manikin, the Airtraq and the McGrath laryngoscopes appeared superior to the Macintosh laryngoscope when dealing with simulated airway scenarios. Both devices were associated with better views, intubation times and rates of success, especially in a simulated "difficult airway". Overall satisfaction was highest with the McGrath laryngoscope. Similar clinical studies are needed.

RESUMO OBJETIVO: Vários dispositivos podem ajudar a intubação nasotraqueal no manejo de via aérea difícil. Os laringoscópios McGrath MAC e Airtraq NT foram comparados com um laringoscópio Macintosh em estudo do desempenho de anestesistas com diferentes níveis de experiência, em manequim com cenário de via aérea fácil ou difícil. MÉTODOS: Foram recrutados 63 anestesistas para um estudo randômico, no qual cada um fez intubação nasotraqueal com todos os laringoscópios, em ambos os cenários. O desfecho primário foi o tempo de intubação. Desfechos adicionais incluíram vista laringoscópica, sucesso na intubação, número de manobras de aprimoramento, cliques dentais audíveis e força aplicada nas vias aéreas superiores. RESULTADOS: O tempo de intubação foi significativamente menor com o uso do laringoscópio McGrath MAC em ambos os cenários e com o uso do Airtraq no cenário difícil, em comparação com o laringoscópio Macintosh. Ambos os dispositivos obtiveram mais grau 1 ou 2 de Cormack e Lehane para visualização do que o Macintosh em cenário difícil (p < 0,001). O McGrath MAC teve a melhor taxa de sucesso na primeira tentativa (98,4% vs. 96,8% e 95,8%, p < 0,001, para os laringoscópios Airtraq NT e Macintosh, respectivamente). O número de manobras de aprimoramento, os cliques dentais audíveis e a avaliação subjetiva do grau de força aplicada foram significativamente menores para os laringoscópios indiretos versus o laringoscópio Macintosh (p < 0,001). CONCLUSÃO: Em um manequim, os laringoscópios Airtraq e McGrath pareceram superiores ao laringoscópio Macintosh para lidar com cenários das vias aéreas simuladas. Ambos os dispositivos foram associados a melhores visibilidades, tempos de intubação e taxas de sucesso, especialmente em simulação de "via aérea difícil". A satisfação geral foi maior com o laringoscópio McGrath. Estudos clínicos similares são necessários.

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.

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. TRIAL REGISTRATION: Current Controlled Trials ISRCTN16615772 . EudraCT number: 2015-002009-12.

A randomised crossover trial comparing the Airtraq(®) NT, McGrath(®) MAC and Macintosh laryngoscopes for nasotracheal intubation of simulated easy and difficult airways in a manikin.

OBJECTIVE: Several devices can aid nasotracheal intubation when managing difficult airways. The McGrath MAC and Airtraq NT were compared with a Macintosh laryngoscope when studying the performance of anaesthetists with different levels of experience, in a manikin model of easy or difficult airway scenarios. METHODS: Sixty-three anaesthetists were recruited into a randomised trial in which each performed nasotracheal intubation with all laryngoscopes, in both scenarios. The main endpoint was intubation time. Additional endpoints included laryngoscopic view, intubation success, number of optimisation manoeuvres, audible dental clicks and the force applied to the upper airway. RESULTS: Intubation time was significantly shorter using the McGrath MAC in both scenarios and using the Airtraq in the difficult scenario, when compared with the Macintosh laryngoscope. Both devices gave more Cormack and Lehane grade 1 or 2 views than the Macintosh in the difficult scenario (p<0.001). The McGrath MAC had the best first-attempt success rate (98.4% vs. 96.8% and 95.8%, p<0.001 for the Airtraq NT and Macintosh laryngoscopes respectively). The number of optimisation manoeuvres, audible dental clicks and subjective assessment of the degree of force applied were significantly lower for indirect laryngoscopes versus the Macintosh laryngoscope (p<0.001). CONCLUSION: In a manikin, the Airtraq and the McGrath laryngoscopes appeared superior to the Macintosh laryngoscope when dealing with simulated airway scenarios. Both devices were associated with better views, intubation times and rates of success, especially in a simulated "difficult airway". Overall satisfaction was highest with the McGrath laryngoscope. Similar clinical studies are needed.

Characteristics and pattern of recurrence after curative surgery in oesophageal cancer.

BACKGROUND AND AIM: Recurrence in oesophageal cancer continues to remain high after curative surgery. The aim of this study was to determine the presence of recurrence after curative surgery during follow-up, and the associated variables. METHODS: A retrospective and prospective follow-up study in patients with an anatomical-pathological diagnosis of oesophageal cancer who underwent curative surgery (n = 57) in the health district of A Coruña (Spain) during the period 2003-2008. The calculation of recurrence-free survival was made using a competing risks survival analysis. RESULTS: Out of the 57 patients included in the study, 87.7% were men with a mean age of 61.4 ± 10.3 years. The median follow-up period was 18.5 months, during which 28 recurrences were detected (50.9%). Patients with dysphagia on diagnosis of the disease, as well as patients in stages III-IV, have a higher probability of recurrence during the follow-up period. The median disease-free interval was 8.5 months. After one year of follow up, 57.1% of the recurrences were diagnosed and 82.1% after 2 years of followup. The median post-recurrence survival rate was 4.7 months. After adjusting for a multivariate regression model, the variable with an independent effect for predicting recurrence is the TNM classification (HR = 8.49). CONCLUSIONS: The majority of the recurrences will be developed during the 2 years after surgery, with a very poor prognosis. The predictor variable for recurrence is the TMN classification.

Factores pronósticos en adultos hospitalizados por neumonía causada por Legionella pneumophila / Prognostic factors in adult patients hospitalized for pneumonia caused by Legionella pneumophila

Introduction: Legionellosis is a multisystem bacterial disease, which causes pneumonia with high mortality in patients with comorbidity and admitted in intensive care units (ICU). Objective: Determine predictors of mortality or ICU admission. Methods: Retrospective follow-up of patients diagnosed with Legionella pneumophila pneumonia in Complexo Hospitalario Universitario de A Coruña. Period 2000-2013 (n = 240). Analysis of multivariate logistic regression was performed. Results: Mean age was 57.2 ± 15.4 years old, 88.3% were male. Average score of comorbidity (Charlson score) was 2.3 ± 2.3. There was a clear seasonal variation. Predominant symptoms were fever (92.5%), dry cough (38.1%) and dyspnea (33.9%). Creatinine clearance was lower than 60 mL/min/1.73 m² in 29.7% and sodium < 135 mEq/l in 58.3%. Admission to ICU rate was 16.3% and 10.8% needs mechanical ventilation. Inhospital mortality rate was 4.6%, rising to 23.1% in patients admitted to ICU. Variables associated to predict ICU admission were age (OR = 0.96), liver disease (OR = 7.13), dyspnea (OR = 4.33), delirium (OR = 5.86) and high levels of lactatedehydrogenase (OR = 1.002). Variables associated with inhospital mortality were Charlson index (OR = 1.70), mechanical ventilation (OR = 31.44) and high levels of lactatedehydrogenase (OR = 1.002). Discussion: Younger patients with liver disease, dyspnea and confusion are more likely to be admitted to ICU. Comorbidity, mechanical ventilation and elevated LDH levels are associated with higher mortality rate.

Introducción: La legionelosis es una enfermedad bacteriana multisistémica, causante de neumonías con mortalidad elevada en pacientes con comorbilidad e ingresos en Unidad de Cuidados Intensivos (UCI). Objetivo: Determinar factores pronósticos de mortalidad o ingreso en UCI. Material y Métodos: Estudio de seguimiento retrospectivo de pacientes diagnosticados de neumonía por Legionella pneumophila en Complexo Hospitalario Universitario de A Coruña (España). Período 2000-2013 (n = 240), con análisis de regresión logística multivariada. Resultados: La edad media fue 57,2 ± 15,4 años, 88,3% fueron hombres. La puntuación media de comorbilidad (score Charlson) fue 2,3 ± 2,3. Existe clara estacionalidad. La clínica predominante fue fiebre (92,5%), tos seca (38,1%) y disnea (33,9%). El 29,7% presentó aclaramiento de creatinina < 60 mL/min/1,73 m² y el 58,3% sodio < 135 mEq/l. Un 16,3% ingresó en UCI, precisando ventilación mecánica invasiva el 10,8%. La mortalidad global fue 4,6% y de 23,1% en ingresados en UCI. Variables asociadas para predecir ingreso en UCI fueron menor edad (OR = 0,96), hepatopatía (OR = 7,13), disnea (OR = 4,33), síndrome confusional (OR = 5,86) y lactato deshidrogenasa elevada (OR = 1,002). Las variables asociadas a mortalidad intrahospitalaria fueron índice de Charlson (OR = 1,70), ventilación mecánica invasiva (OR = 31,44) y cifras elevadas de lactato deshidrogenasa (OR = 1,002). Discusión: Pacientes jóvenes, con hepatopatía, disnea o confusión tienen más probabilidad de ingresar en UCI. Comorbilidad, ventilación mecánica y lactato deshidrogenasa elevada se asocian a mortalidad.

Clinical-pathological characteristics and prognosis of a cohort of oesophageal cancer patients: a competing risks survival analysis.

BACKGROUND: To determine the clinical course, follow-up strategies, and survival of oesophageal cancer patients using a competing risks survival analysis. METHODS: We conducted a retrospective and prospective follow-up study. The study included 180 patients with a pathological diagnosis of oesophageal cancer in A Coruña, Spain, between 2003 and 2008. The Kaplan-Meier methodology and competing risks survival analysis were used to calculate the specific survival rate. The study was approved by the Ethics Review Board (code 2011/372, CEIC Galicia). RESULTS: The specific survival rate at the first, third, and fifth years was 40.2%, 18.1%, and 12.4%, respectively. Using the Kaplan-Meier methodology, the survival rate was slightly higher after the third year of follow-up. In the multivariate analysis, poor prognosis factors were female sex (hazard ratio [HR] 1.94; 95% confidence interval [CI], 1.24-3.03), Charlson's comorbidity index (HR 1.17; 95% CI, 1.02-1.33), and stage IV tumours (HR 1.70; 95% CI, 1.11-2.59). The probability of dying decreased with surgical and oncological treatment (chemotherapy and/or radiotherapy) (HR 0.23; 95% CI, 0.12-0.45). The number of hospital consultations per year during the follow-up period, from diagnosis to the appearance of a new event (local recurrences, newly appeared metastasis, and newly appeared neoplasias) did not affect the probability of survival (HR 1.03; 95% CI, 0.92-1.15). CONCLUSIONS: The Kaplan-Meier methodology overestimates the survival rate in comparison to competing risks analysis. The variables associated with a poor prognosis are female sex, Charlson's comorbidity score and extensive tumour invasion. Type of follow-up strategy employed after diagnosis does not affect the prognosis of the disease.

Age differences in presentation, diagnosis pathway and management of colorectal cancer.

BACKGROUND: The gap in survival between older and younger European cancer patients is getting wider. It is possible that cancer in the elderly is being managed or treated differently than in their younger counterparts. This study aims to explore age disparities with respect to the clinical characteristics of the tumour, diagnostic pathway and treatment of colorectal cancer patients. METHODS: We conducted a multicenter cross sectional study in 5 Spanish regions. Consecutive incident cases of CRC were identified from pathology services. MEASUREMENTS: From patient interviews, hospital and primary care clinical records, we collected data on symptoms, stage, doctors investigations, time duration to diagnosis/treatment, quality of care and treatment. RESULTS: 777 symptomatic cases, 154 were older than 80 years. Stage was similar by age group. General symptoms were more frequent in the eldest and abdominal symptoms in the youngest. No differences were found regarding perception of symptom seriousness and symptom disclosure between age groups as no longer duration to diagnosis or treatment was observed in the oldest groups. In primary care, only ultrasound is more frequently ordered in those <65 years. Those >80 years had a significantly higher proportion of iron testing and abdominal XR requested in hospital. We observed a high resection rate independently of age but less adjuvant chemotherapy in Stage III colon cancer, and of radiotherapy in stage II and III rectal cancer as age increases. CONCLUSION: There are no relevant age disparities in the CRC diagnosis process with similar stage, duration to diagnosis, investigations and surgery. However, further improvements have to be made with respect to adjuvant therapy.

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

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.

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.