Intention to treat and per protocol analyses: differences and similarities.

Randomized trials can take more explanatory or more pragmatic approaches. Pragmatic studies, conducted closer to real-world conditions, assess treatment effectiveness while considering factors like protocol adherence. In these studies, intention-to-treat (ITT) analysis is fundamental, comparing outcomes regardless of the actual treatment received. Explanatory trials, conducted closer to optimal conditions, evaluate treatment efficacy, commonly with a per protocol (PP) analysis, which includes only outcomes from adherent participants. ITT and PP are strategies used in the conception, design, conduct (protocol execution), analysis, and interpretation of trials. Each serves distinct objectives. While both can be valid, when bias is controlled, and complementary, each has its own limitations. By excluding non-adherent participants, PP analyses can lose the benefits of randomization, resulting in group differences in factors (influencing adherence and outcomes) that were present at baseline. Additionally, clinical and social factors affecting adherence can also operate during follow-up, i.e., after randomization. Therefore, incomplete adherence may introduce postrandomization confounding. Conversely, ITT analysis, including all participants regardless of adherence, may dilute treatment effects. Moreover, varying adherence levels could limit the applicability of ITT findings in settings with diverse adherence patterns. Both ITT and PP analyses can be affected by selection bias due to differential losses and nonresponse (i.e., missing data) during follow-up. Combining high quality and comprehensive data with advanced statistical methods, known as g-methods, like inverse probability weighting, may help address postrandomization confounding in PP analysis, as well as selection bias in both ITT and PP analyses.

Patient experience, satisfaction and shared decision-making in colorectal cancer screening: protocol of the mixed-methods study CyDESA.

INTRODUCTION: Colorectal cancer (CRC) screening programmes can reduce incidence and mortality from this condition if adherence to them is high. As patient experience and satisfaction are key factors in determining adherence to screening programmes, they need to be measured. Furthermore, to promote highly patient-centred healthcare, the perception of patients regarding shared decision-making during CRC screening needs to be known. This study aims to assess the experience, satisfaction and participation in decision-making of participants in a CRC screening programme and of patients diagnosed with CRC through this programme in relation to the diagnostic and therapeutic processes of cancer. METHODS AND ANALYSIS: The CyDESA study is a mixed-methods study with a four phase sequential design. In phase 1, we will conduct a systematic review of patient-reported experience measures (PREMs) for patient experience or satisfaction with CRC screening. In case no located PREM can be applied, in phase 2, we will develop a new PREM. We will use the Delphi methodology to reach consensus among experts and patients and will conduct a pilot test of the developed PREM. Phase 3 is a multicentric cross-sectional study based on self-reported questionnaires that will be conducted at three Spanish hospitals (n=843). The objective is to find out about the experience, satisfaction and participation in decision-making of participants in the CRC screening programme who have had a positive screening test result according to their final screening diagnosis: false positives, colorectal polyps or CRC. Phase 4 is a qualitative phenomenological study based on individual interviews. It will explore the experiences of participants in the CRC screening programme and of those diagnosed with CRC. ETHICS AND DISSEMINATION: Ethics approval by the Ethics Committees of Corporació Sanitària Parc Taulí, Hospital de Sant Pau and Parc de Salut Mar. Findings will be published in peer-reviewed journals and presented at conferences. TRIAL REGISTRATION NUMBER: NCT04610086.

Non-Pharmacological Preventive Measures Had an Impact on COVID-19 in Healthcare Workers before the Vaccination Effect: A Cohort Study.

Healthcare workers have been and still are at the forefront of COVID-19 patient care. Their infection had direct implications and caused important challenges for healthcare performance. The aim of this study is to assess the impact of non-pharmacological preventive measures against COVID-19 among healthcare workers. This study is based on a dynamic cohort of healthcare workers (n = 5543) who had been hired by a Spanish hospital for at least one week during 2020. Negative binomial regression models were used to estimate the incidence rate and the rate ratio (RR) between the two waves (defined from 15 March to 21 June and from 22 June to 31 December), considering natural immunity during the first wave and contextual variables. All models were stratified by socio-occupational variables. The average COVID-19 incidence rate per 1000 worker-days showed a significant reduction between the two waves, dropping from 0.82 (CI95%: 0.73-0.91) to 0.39 (0.35-0.44). The adjusted RR was 0.54 (0.48-0.87) when natural immunity was acquired during the first wave, and contextual variables were considered. The significant reduction of the COVID-19 incidence rate could be explained mainly by improvement in the non-pharmacological preventive interventions. It is needed to identify which measures were more effective. Young workers and those with a replacement contract were identified as vulnerable groups that need greater preventive efforts. Future preparedness plans would benefit from these results.

Risk-stratified strategies in population screening for colorectal cancer.

Colorectal cancer (CRC) screening has been demonstrated to reduce CRC incidence and mortality. However, besides such benefits, CRC screening is also associated with potential harmful effects. In an ideal world, screening would only be directed to the small proportion of the population that might potentially benefit. Risk-based screening can be seen as a first step towards this ideal world, by redistributing screening resources from low-risk to high-risk individuals. In theory, this should result in scarce resources being used in individuals who benefit most, while intensity of screening is reduced in individuals who benefit less, hence improving the benefit-harm ratio among all invitees. Available strategies that have been proposed for risk-based CRC screening include using information on age, sex, prior screening history, lifestyle and/or genetic information. Implementation of risk-based screening requires careful consideration of reliable risk prediction models, participation with screening and informed decision-making. While it is important to recognise the limitations of current approaches, available evidence suggests that it might be feasible to start planning the introduction of tailored strategies within screening programmes. Implementing risk-based screening based on age, sex and prior screening history alone would already represent a substantial improvement over current uniform screening approaches. We propose that it is time that screening programmes start there and continue striving towards more comprehensive approaches embedding primary prevention as an effective approach to lower risk for everyone.

Impact and Management of COVID-19 Among Healthcare Workers in Two Acute Care Hospitals and Two Associated Long-term Care Centres in Barcelona, Spain.

OBJECTIVE: To describe the characteristics of COVID-19-related episodes in healthcare workers (HCW) of two hospitals. METHODS: Prospective study of HCW with COVID-like symptoms and/or who were close contacts of confirmed COVID-19. The percentage of positive PCRs among those with symptoms was calculated, and symptom's positive predictive value and negative predictive value. The characteristics of contacts were described, as well as the secondary clinical attack rate. RESULTS: We registered 1222 episodes of HCW with COVID-like symptoms; 340 (27.8%) had a positive PCR. In 885 episodes, a HCW was a close contact of a confirmed case. In 45.5% of these, the HCW had contact with another HCW. The secondary clinical attack rate of contacts of HCW was 14.5%. CONCLUSION: We found a high prevalence of disease and transmission between HCW during the first wave of the SARS-CoV-2 pandemic.

Effect of an information leaflet on breast cancer screening participation: A cluster randomized controlled trial.

OBJECTIVE: To evaluate the impact of an information leaflet about the risk-benefit balance of breast cancer screening on women's participation. METHODS: This cluster randomized controlled trial was conducted within a population-based breast cancer screening program and included women from the catchment areas of two hospitals in Barcelona, Spain. We evaluated women aged 50-69 years invited to screening between September 2019 and January 2020. The intervention group received an information leaflet on the benefits and harms of mammography screening. The control group received the usual invitation letter. The clusters consisted of the processing days of the invitation letter, assigned to the intervention with a simple random allocation scheme. We compared the participation rate at the individual level between groups, stratified by hospital and by per-protocol and intention-to-treat analyses. RESULTS: We included 11,119 women (137 clusters): 5416 in the intervention group (66 clusters) and 5703 in the control group (71 clusters). A total of 36% (1964/5393) of the women in the intervention group and 37% (2135/5694) of those in the control group attended screening, respectively. Overall, we found no differences in participation among groups (difference in participation - 1.1%; 95%CI; - 2.9 to 0.7%). In a hospital attending a population with a low socioeconomic status, attendance was lower in the intervention group (- 1.4, 95%CI: - 5.7% to - 0.03%). CONCLUSIONS: Overall participation in our program was unaffected by a new information leaflet on the risk-benefit balance of breast cancer screening. However, participation was lower in certain populations with lower socioeconomic status TRIAL REGISTRATION: Trial registration number ISRCTN13848929 .

Early assessment of the first wave of the COVID-19 pandemic on cancer screening services: The International Cancer Screening Network COVID-19 survey.

Screening can decrease the burden of breast, cervical, and colorectal cancers. The COVID-19 pandemic led many countries to suspend cancer screening services as part of their response to the pandemic. The International Cancer Screening Network (ICSN) carried out an online survey to assess the effects of the first wave of the COVID-19 pandemic on cancer screening. A 33-item survey was distributed to 834 email addresses to gather information about settings and assess decision-making processes that led to cancer screening suspension. Information about communication, impact on resources, and patient follow-up was collected. Quantitative data was analyzed as frequencies overall and by setting, while a comment section under each survey item captured nuanced details. Responses were recategorized into 66 settings, representing 35 countries. Most settings suspended cancer screening services (n = 60, 90.9%) in March 2020 (n = 45, 68.2%), guided by a government decision (n = 51, 77.3%). Few settings made the decision whether to suspend services based on a preparedness plan (n = 17, 25.8%). In most settings, professionals were reassigned (n = 41, 62.1%) and infrastructure repurposed (n = 35, 53.0%). The first wave of the COVID-19 pandemic has had profound effects on cancer screening worldwide, including the suspension of services in almost all settings. Most settings were unprepared to deal with the scale of the pandemic but demonstrated flexibility in the response. These results contribute to inform, through experiences and lessons learned, the next steps for the global cancer screening community to further evaluate the impact of COVID-19 and prepare for future disruptions.

Interruption of cancer screening services due to COVID-19 pandemic: lessons from previous disasters.

PURPOSE: To review the scientific literature seeking lessons for the COVID-19 era that could be learned from previous health services interruptions that affected the delivery of cancer screening services. METHODS: A systematic search was conducted up to April 17, 2020, with no restrictions on language or dates and resulted in 385 articles. Two researchers independently assessed the list and discussed any disagreements. Once a consensus was achieved for each paper, those selected were included in the review. RESULTS: Eleven articles were included. Three studies were based in Japan, two in the United States, one in South Korea, one in Denmark, and the remaining four offered a global perspective on interruptions in health services due to natural or human-caused disasters. No articles covered an interruption due to a pandemic. The main themes identified in the reviewed studies were coordination, communication, resource availability and patient follow-up. CONCLUSION: Lessons learned applied to the context of COVID-19 are that coordination involving partners across the health sector is essential to optimize resources and resume services, making them more resilient while preparing for future interruptions. Communication with the general population about how COVID-19 has affected cancer screening, measures taken to mitigate it and safely re-establish screening services is recommended. Use of mobile health systems to reach patients who are not accessing services and the application of resource-stratified guidelines are important considerations. More research is needed to explore best strategies for suspending, resuming and sustaining cancer screening programs, and preparedness for future disruptions, adapted to diverse health care systems.

Predictors of Metachronous Risk Polyps After Index Colonoscopy.

INTRODUCTION: Guidelines for surveillance after polypectomy are lacking in strong evidence. Our aim was to identify some precursors of colorectal cancer lesions at 3 years after polypectomy to improve stratification and surveillance programs. METHODS: We included patients with high-risk lesions (HRLs), defined as advanced adenoma (AA), large serrated polyps (SPs), and multiplicity (≥3 of any adenomas/SPs). Data on age, sex, cardiovascular risk factors, pharmacological treatment, and the histological characteristics in each individual, and mutations in genes involved in the most advanced index polyp, were collected. Parameters independently associated with a metachronous HRL diagnosis were evaluated through univariate and multivariate analyses. The results are reported as odds ratios and 95% confidence intervals along with P values. RESULTS: A total of 537 cases (median age: 60.7 years; 66% male) were included. Dyslipidemia and smoking correlated with metachronous HRLs. Multivariate logistic regression analysis showed that the presence of multiplicity with ≥3 polyps on the index colonoscopy was significantly associated with metachronous HRL, AA, proximal AA, and ≥3 polyps at 3 years. In addition, independent predictors of metachronous proximal AA were increasing age, female sex, and the loss of expression of the MLH1 protein. DISCUSSION: Multiplicity was a strong predictor of HRLs at 3 years, although the inclusion of other clinical variables (age, sex, smoking status, and dyslipidemia) improves surveillance recommendations. Without these risk factors, the surveillance could be extended to 5 years; we propose examining the somatic expression of MHL1 in all patients.

Cribado poblacional de cáncer colorrectal: cánceres de intervalo y relación con el resultado cuantitativo del test inmunológico de sangre oculta en heces / Population-based colorectal cancer screening: Interval cancers and relationship with the quantitative faecal immunological for hemoglobin

Introducción y objetivo: La sensibilidad de los programas de cribado de cáncer colorrectal determina su efectividad y está directamente relacionada con el cáncer de intervalo (CI). Este estudio describe la frecuencia y las características de los CI del Programa de la ciudad de Barcelona y analiza su relación con el valor cuantitativo del test de cribado previo (FIT). Material y métodos: Se incluyen los CI tras FIT negativo de las primeras dos rondas del Programa (2010-2013); periodo de observación hasta julio de 2017. La fuente de información de los CI es su notificación por profesionales y pacientes y el cruce de bases de datos hospitalarias y CMBD. Resultados: La sensibilidad del Programa es del 82%. Los CI se diagnostican más en colon proximal y recto y en estadios avanzados que los cánceres de cribado, y presentan valores FIT más elevados que el conjunto de personas con FIT negativo. Conclusiones: La sensibilidad obtenida es aceptable y comparable a la de otros programas. El valor cuantitativo del FIT en personas con test negativo debería incluirse en las estrategias de personalización del cribado para reducir el riesgo de CI

Introduction and objective: The sensitivity of colorectal cancer screening programmes determines their effectiveness and is directly related to the interval cancer (IC). This study describes the frequency and characteristics of the IC of the Programme of Barcelona, Spain, and analyses its relationship with the quantitative value of the screening test (FIT). Material and methods: ICs after negative FIT of the first two rounds of the Programme (2010-2013) were included, observation period until July 2017. The information source of the ICs was their notification by professionals and patients, hospital databases and CMBD (Spanish Minimum Basic Data Set). Results: The sensitivity of the Programme is 82%. ICs are diagnosed more in proximal and rectal colon and in advanced stages than screening cancers, and have higher FIT values than overall people with negative FIT. Conclusions: The sensitivity is acceptable and comparable to that of other programmes. The quantitative value of FIT in people with negative test should be included in the personalisation strategies of screening to reduce the risk of IC

Public health etichs education in public health masters in Spain: Current status and available resources for teaching / La educación en ética de la salud pública en los másteres de salud pública en España: Situación actual y recursos disponibles para la docencia / L'educació en ètica de la salut pública en els màsters de salut pública a Espanya: Situació actual i recursos disponibles per a la docència

Ethics education of public health (PH) professionals is insufficient, despite general consensus on the need for it. This article aims to describe the extent to which Spanish masters of public health (MPH) have adopted ethic courses, and to review teaching and/or learning resources on PH ethics available in English. We explored Internet sites from current MPH in Spain and searched for teaching resources using different strategies. A total of 14 MPH were identified out of which seven (50.0%) teach ethics. Ethics is taught together with other aspects of PH in all cases. A total of 12 textbooks on PH ethics were reviewed, 5 of them include case studies and most have good or high value as teaching tools

La formación en ética de los profesionales en salud pública (SP) es necesaria pero insuficiente. Este artículo pretende describir el grado en que los masters de salud pública (MSP) en España incluyen la ética en su programa y revisar los materiales docentes de ética en SP disponibles en lengua inglesa. Examinamos en Internet el programa de los MSP y los materiales docentes utilizando diferentes estrategias de búsqueda. De los 14 MSP identificados, la mitad (7) incluyen la ética en su programa y en todos los casos ésta se enseña junto con otros aspectos de SP. Doce libros de texto fueron revisados, 5 de los cuales incluyen casos prácticos y casi todos tienen un alto valor como material docente

La formació en ètica dels professionals en salut pública (SP) és necessària però insuficient. Aquest article pretén descriure el grau en què els màsters de salut pública (MSP) a Espanya inclouen l'ètica en el seu programa i revisar els materials docents d'ètica en SP disponibles en llengua anglesa. Examinem a Internet el programa dels MSP i els materials docents utilitzant diferents estratègies de cerca. Dels 14 MSP identificats, la meitat (7) inclouen l'ètica en el seu programa i en tots els casos aquesta s'ensenya juntament amb altres aspectes de SP. Dotze llibres de text van ser revisats, 5 dels quals inclouen casos pràctics i gairebé tots ells tenen un alt valor com a material docent

Effectiveness of a decision aid for promoting colorectal cancer screening in Spain: a randomized trial.

BACKGROUND: Colorectal cancer (CRC) screening has shown to reduce incidence and mortality rates, and therefore is widely recommended for people above 50 years-old. However, despite the implementation of population-based screening programs in several countries, uptake rates are still low. Decision aids (DAs) may help patients to make informed decisions about CRC screening. METHODS: We performed a randomized controlled trial to assess the effectiveness of a DA developed to promote CRC screening, with patients from two primary care centers in Spain who never had underwent CRC screening. Contrary to center B (n = 24), Center A (n = 83) attended patients from an area where the population-based screening program was not implemented at that moment. Outcome measures were decisional conflict, knowledge of the disease and available screening options, intention to uptake the test, and concordance between patients' goals/concerns and intention. RESULTS: In center A, there were significant differences favoring the DA in decisional conflict (p < 0.001) and knowledge (p < 0.001). The absolute differences favoring DA group in intention to undergo fecal occult blood test (10.5%) and colonoscopy (13.7%) were significant only before correction for attenuation. In center B the differences were significant only for knowledge (p < 0.001). Patients' goals and concerns regarding the screening did not significantly predict their intention, and therefore we could not calculate a measure of concordance between the two constructs. CONCLUSIONS: A DA improved the decisional process of participants who had never been invited to participate in the Spanish public CRC screening program, replicating previous results in this field. Future research is needed to identify subgroups that could benefit more from these interventions. TRIAL REGISTRATION: International Standard Registered Clinical/social Study Number: ISRCTN98108615 (Retrospectively registered on 27 December 2018).

Population-based colorectal cancer screening: Interval cancers and relationship with the quantitative faecal immunological for hemoglobin. / Cribado poblacional de cáncer colorrectal: cánceres de intervalo y relación con el resultado cuantitativo del test inmunológico de sangre oculta en heces.

INTRODUCTION AND OBJECTIVE: The sensitivity of colorectal cancer screening programmes determines their effectiveness and is directly related to the interval cancer (IC). This study describes the frequency and characteristics of the IC of the Programme of Barcelona, Spain, and analyses its relationship with the quantitative value of the screening test (FIT). MATERIAL AND METHODS: ICs after negative FIT of the first two rounds of the Programme (2010-2013) were included, observation period until July 2017. The information source of the ICs was their notification by professionals and patients, hospital databases and CMBD (Spanish Minimum Basic Data Set). RESULTS: The sensitivity of the Programme is 82%. ICs are diagnosed more in proximal and rectal colon and in advanced stages than screening cancers, and have higher FIT values than overall people with negative FIT. CONCLUSIONS: The sensitivity is acceptable and comparable to that of other programmes. The quantitative value of FIT in people with negative test should be included in the personalisation strategies of screening to reduce the risk of IC.

Changes in FIT values below the threshold of positivity and short-term risk of advanced colorectal neoplasia: Results from a population-based cancer screening program.

INTRODUCTION: Increased values in the fecal immunochemical test (FIT) are correlated with increasingly severe colorectal neoplasia, but little attention has been given to FIT values below the cut-off point (negative FIT, nFIT). We analysed the relationship between the concentrations of two consecutive nFIT and the risk of following screen-detected advanced neoplasia and interval cancer (IC) in a population-based colorectal cancer screening program. METHODS: FIT results were categorised into non-detectable nFIT (0-3.8 µg haemoglobin/g feces), low nFIT (3.9-9.9) and high nFIT (10.0-19.9). Multivariable adjusted logistic regression was used to estimate the odds ratios (OR) of advanced neoplasia and IC with the nFIT results in the first two screens. RESULTS: More than 90% of the 42,524 persons had non-detectable nFIT in the first and second screen; 4.5% and 5.8% had a low nFIT, respectively, and 2.2% and 2.9% had a high nFIT. The probability of testing positive and being diagnosed of advanced neoplasia or IC rose with increasing values of nFIT. Compared with those with two non-detectable nFIT results, the highest OR were found among those who had two high nFIT results (OR 21.75; 95% confidence interval: 12.44, 38.04) and those with one low nFIT and one high nFIT (ORs around 20). CONCLUSIONS: Participants with nFIT results above the detection limit of the test had an increased risk of advanced neoplasia and IC in subsequent participations. This information could be used in the design of personalised screening strategies.

Usefulness of the KDPI in Spain: A comparison with donor age and definition of standard/expanded criteria donor / Utilidad del índice KDPI en España: una comparación con la edad del donante y la definición de donante con criterios de selección estándar/ampliados

INTRODUCTION: Kidney donor shortage requires expanding donor selection criteria, as well as use of objective tools to minimize the percentage of discarded organs. Some donor pre-transplant variables such as age, standard/expanded criteria donor (SCD/ECD) definition and calculation of the Kidney Donor Profile Index (KDPI), have demonstrated correlations with patient and graft outcomes. We aimed to establish the accuracy of the three models to determine the prognostic value of kidney transplantation (KT) major outcomes. MATERIAL AND METHODS: We performed a retrospective study in deceased donor KTs at our institution. Unadjusted Cox and Kaplan-Meier survival, and multivariate Cox analyses were fitted to analyze the impact of donor age, SCD/ECD and KDPI on outcomes. RESULTS: 389 KTs were included. Mean donor age was 53.6 ± 15.2 years; 163 (41.9%) came from ECD; mean KDPI was 69.4 ± 23.4%. Median follow-up was 51.9 months. The unadjusted Cox and Kaplan-Meier showed that the three prognostic variables of interest were related to increased risk of patient death, graft failure and death-censored graft failure. However, in the multivariate analysis only KDPI was related to a higher risk of graft failure (HR 1.03 [95% CI 1.01-1.05]; p = 0.014). CONCLUSIONS: SCD/ECD classification did not provide significant prognostic information about patient and graft outcomes. KDPI was linearly related to a higher risk of graft failure, providing a better assessment. More studies are needed before using KDPI as a tool to discard or accept kidneys for transplantation

INTRODUCCIÓN: La escasez de donantes de riñón requiere una ampliación de los criterios de selección de donantes, así como el uso de herramientas objetivas para minimizar el porcentaje de órganos descartados. Algunas variables pretrasplante del donante, como la edad, la definición de donante con criterios de selección estándar/ampliados (standard/expanded criteria donor [SCD/ECD]) y el cálculo del índice del perfil de donante renal (Kidney Donor Profile Index [KDPI]) han demostrado correlación con los resultados del paciente y el injerto. Nuestro objetivo fue evaluar la precisión de 3 modelos diferentes para determinar el valor pronostico en los resultados del trasplante renal. MATERIALES Y MÉTODOS: Llevamos a cabo un estudio retrospectivo de TR de donantes fallecidos en nuestro centro. Se realizó un analisis de supervivencia mediante curvas de Kaplan-Meir y Cox no ajustado, ai como un analisis multivariante de Cox para analizar el impacto de la edad del donante, la definición SCD/ECD y el índice KDPI sobre los resultados. RESULTADOS: Se incluyeron 389 TR. La media de edad de los donantes era de 53,6 ± 15,2 años; 163 (41,9%) procedían de donantes ECD; el índice KDPI medio era de 69,4 ± 23,4%. La mediana de seguimiento era de 51,9 meses. Los análisis de Kaplan-Meier y de Cox no ajustado mostraron que las 3 variables pronósticas de interés estaban relacionadas con un mayor riesgo de muerte del paciente, fracaso del injerto y fracaso del injerto censurado por la muerte. Sin embargo, en el análisis multivariable solamente el índice KDPI estuvo relacionado con un mayor riesgo de fracaso del injerto (HR: 1,03 [IC 95%: 1,01-1,05]; p = 0,014). CONCLUSIONES: La clasificación SCD/ECD no proporcionó información pronóstica significativa sobre los desenlaces del paciente y el injerto. El índice KDPI estuvo linealmente relacionado con un mayor riesgo de fracaso del injerto, por lo que ofrecía una mejor evaluación. Es necesario realizar más estudios antes de usar el índice KDPI como herramienta para descartar o aceptar riñones para trasplante

Usefulness of the KDPI in Spain: A comparison with donor age and definition of standard/expanded criteria donor.

INTRODUCTION: Kidney donor shortage requires expanding donor selection criteria, as well as use of objective tools to minimize the percentage of discarded organs. Some donor pre-transplant variables such as age, standard/expanded criteria donor (SCD/ECD) definition and calculation of the Kidney Donor Profile Index (KDPI), have demonstrated correlations with patient and graft outcomes. We aimed to establish the accuracy of the three models to determine the prognostic value of kidney transplantation (KT) major outcomes. MATERIAL AND METHODS: We performed a retrospective study in deceased donor KTs at our institution. Unadjusted Cox and Kaplan-Meier survival, and multivariate Cox analyses were fitted to analyze the impact of donor age, SCD/ECD and KDPI on outcomes. RESULTS: 389 KTs were included. Mean donor age was 53.6±15.2 years; 163 (41.9%) came from ECD; mean KDPI was 69.4±23.4%. Median follow-up was 51.9 months. The unadjusted Cox and Kaplan-Meier showed that the three prognostic variables of interest were related to increased risk of patient death, graft failure and death-censored graft failure. However, in the multivariate analysis only KDPI was related to a higher risk of graft failure (HR 1.03 [95% CI 1.01-1.05]; p=0.014). CONCLUSIONS: SCD/ECD classification did not provide significant prognostic information about patient and graft outcomes. KDPI was linearly related to a higher risk of graft failure, providing a better assessment. More studies are needed before using KDPI as a tool to discard or accept kidneys for transplantation.

Adherencia al seguimiento de las personas con adenoma de alto riesgo diagnosticadas y excluidas del Programa de detección precoz de cáncer de colon y recto de Barcelona / Adherence to follow-up in high-risk adenoma patients diagnosed by, and excluded from the Barcelona colorectal cancer screening programme

INTRODUCCIÓN: Los programas de detección precoz de cáncer colorrectal han demostrado reducir la mortalidad y la incidencia de este cáncer. Del conjunto de lesiones diagnosticadas en los programas, los adenomas de alto riesgo (AAR) son las más frecuentes. Los AAR son derivados al especialista pero son escasos los estudios que han evaluado la adherencia al seguimiento endoscópico recomendado. OBJETIVOS: Analizar la adherencia y el intervalo de seguimiento de personas diagnosticadas de AAR en un programa de cribado. MÉTODOS: Estudio de cohorte retrospectivo, de personas diagnosticadas de AAR en uno de los centros hospitalarios del Programa de detección precoz de cáncer colorrectal en Barcelona durante la primera ronda (2010-2011). El periodo de observación fue de 75,5 meses. Se realizaron análisis descriptivos y modelos de regresión logística y de supervivencia. RESULTADOS: La población de estudio fue de 602 personas, el 66,6% hombres. La tasa de adherencia fue del 83,7% (n = 504). El 57,7% realizaron la colonoscopia de seguimiento en el intervalo de tiempo recomendado (36 ± 6 meses), con una media de 34 meses. En la regresión de Cox solo se observaron diferencias según el índice socioeconómico, con menor adherencia en el quintil de mayor privación (HR 0,70; IC 95%: 0,53-0,93). CONCLUSIONES: La adherencia al seguimiento se consideró aceptable al compararla con estudios previos, si bien en un alto porcentaje no se realizó en el tiempo recomendado. Es necesario explorar los motivos de la menor adherencia del grupo de mayor privación para diseñar estrategias que mejoren la equidad del Programa más allá de la participación

INTRODUCTION: Colorectal cancer screening programmes have been shown to reduce incidence and mortality. High-risk adenomas (HRA) are the most frequently diagnosed lesions in these programmes, and these patients are referred to a specialist. However, few studies have evaluated the adherence of HRA patients to the recommended endoscopic follow-up. OBJECTIVES: To analyse follow-up adherence and duration in patients diagnosed with HRA in a screening programme. METHODS: Retrospective cohort study of patients diagnosed with HRA within one of the participating hospitals of the colorectal cancer screening programme of Barcelona, during the first round of the programme (2010-2011). The follow-up period was 75.5 months. Descriptive analyses, logistic regression and survival models were performed. RESULTS: 602 patients were included in the study, 66.6% of which were men. The adherence rate was 83.7% (n= 504). Follow-up colonoscopy was performed within the recommended time (36±6 months) in 57.7%, with a mean follow-up of 34 months. The Cox regression only showed differences at the socioeconomic level, with a lower adherence rate in the most deprived quintile (HR 0.70; 95% CI, 0.53-0.93). CONCLUSIONS: Compared to previous studies, the follow-up adherence rate is considered to be acceptable. However, follow-up was not performed within the recommended time frame in a high proportion of cases. There is a need to further explore the reasons leading to lower follow-up adherence in the most deprived socioeconomic group and to increase the equity of the programme beyond participation

Adherence to follow-up in high-risk adenoma patients diagnosed by, and excluded from the Barcelona colorectal cancer screening programme. / Adherencia al seguimiento de las personas con adenoma de alto riesgo diagnosticadas y excluidas del Programa de detección precoz de cáncer de colon y recto de Barcelona.

INTRODUCTION: Colorectal cancer screening programmes have been shown to reduce incidence and mortality. High-risk adenomas (HRA) are the most frequently diagnosed lesions in these programmes, and these patients are referred to a specialist. However, few studies have evaluated the adherence of HRA patients to the recommended endoscopic follow-up. OBJECTIVES: To analyse follow-up adherence and duration in patients diagnosed with HRA in a screening programme. METHODS: Retrospective cohort study of patients diagnosed with HRA within one of the participating hospitals of the colorectal cancer screening programme of Barcelona, during the first round of the programme (2010-2011). The follow-up period was 75.5 months. Descriptive analyses, logistic regression and survival models were performed. RESULTS: 602 patients were included in the study, 66.6% of which were men. The adherence rate was 83.7% (n=504). Follow-up colonoscopy was performed within the recommended time (36±6months) in 57.7%, with a mean follow-up of 34 months. The Cox regression only showed differences at the socioeconomic level, with a lower adherence rate in the most deprived quintile (HR 0.70; 95% CI, 0.53-0.93). CONCLUSIONS: Compared to previous studies, the follow-up adherence rate is considered to be acceptable. However, follow-up was not performed within the recommended time frame in a high proportion of cases. There is a need to further explore the reasons leading to lower follow-up adherence in the most deprived socioeconomic group and to increase the equity of the programme beyond participation.

Impact of comorbid conditions on participation in an organised colorectal cancer screening programme: a cross-sectional study.

BACKGROUND: There is controversy regarding how comorbidity impacts on colorectal cancer screening, especially in the context of organised programmes. The aim of this study is to assess the effect of comorbidities on participation in the Barcelona population-based colorectal cancer screening programme (BCCSP). METHODS: Cross-sectional study carried out in ten primary care centres involved in the BCCSP. Individuals aged 50 to 69, at average risk of colorectal cancer, who were invited to participate in the first round of the faecal immunochemical test-based BCCSP were included (2011-2012). The main variable was participation in the BCCSP. Comorbidity was assessed by clinical risk group status. Other adjusting variables were age, sex, socioeconomic deprivation, visits to primary care, smoking, alcohol consumption and body mass index. Logistic regression models were used to test the association between participation in the programme and potential explanatory variables. The results were given as incidence rate ratios (IRR) and their 95% confidence intervals (CI). RESULTS: Of the 36,208 individuals included, 17,404 (48%) participated in the BCCSP. Participation was statistically significantly higher in women, individuals aged 60 to 64, patients with intermediate socioeconomic deprivation, and patients with more medical visits. There was a higher rate of current smoking, high-risk alcohol intake, obesity and individuals in the highest comorbidity categories in the non-participation group. In the adjusted analysis, only individuals with multiple minor chronic diseases were more likely to participate in the BCCSP (IRR 1.14; 95% CI [1.06 to 1.22]; p < 0.001). In contrast, having three or more dominant chronic diseases was associated with lower participation in the screening programme (IRR 0.76; 95% CI [0.65 to 0.89]; p = 0.001). CONCLUSIONS: Having three or more dominant chronic diseases, was associated with lower participation in a faecal immunochemical test-based colorectal cancer screening programme, whereas individuals with multiple minor chronic diseases were more likely to participate. Further research is needed to explore comorbidity as a cause of non-participation in colorectal cancer screening programmes and which individuals could benefit most from colorectal cancer screening.

Association between socioeconomic deprivation and colorectal cancer screening outcomes: Low uptake rates among the most and least deprived people.

BACKGROUND: Screening with faecal occult blood tests reduces colorectal cancer-related mortality; however, age, sex and socioeconomic factors affect screening outcomes and could lead to unequal mortality benefits. The aim of this study was to describe the main outcomes of the population-based Barcelona colorectal cancer screening programme (BCRCSP) by deprivation. METHODS: Retrospective study of the eligible population of the first round of the BCRCSP. Participants' postal addresses were linked with the MEDEA database to obtain the deprivation quintiles (Dq). Chi-squared tests were used to compare proportions across variables and logistic regression was used to estimate the adjusted effects of age, sex and deprivation on uptake, FIT positivity, colonoscopy adherence and advanced neoplasia detection rate. RESULTS: Overall uptake was 44.7%, higher in Dq2, 3 and 4 (OR 1.251, 1.250 and 1.276, respectively) than in the least deprived quintile (Dq 1), and lowest in Dq5 (OR 0.84). Faecal immunochemical test (FIT) positivity and the percentage of people with detectable faecal haemoglobin below the positivity threshold increased with deprivation. The advanced neoplasia detection rate was highest in Dq4. CONCLUSION: Unlike most regions where inequalities are graded along the socioeconomic continuum, inequalities in the uptake of colorectal cancer screening in Spain seem to be concentrated first in the most disadvantaged group and second in the least deprived group. The correlation of deprivation with FIT-positivity and faecal haemoglobin below the positivity threshold is worrying due to its association with colorectal cancer and overall mortality.