Trajectories of chronic multimorbidity patterns in older patients: MTOP study.

BACKGROUND: Multimorbidity is associated with negative results and poses difficulties in clinical management. New methodological approaches are emerging based on the hypothesis that chronic conditions are non-randomly associated forming multimorbidity patterns. However, there are few longitudinal studies of these patterns, which could allow for better preventive strategies and healthcare planning. The objective of the MTOP (Multimorbidity Trajectories in Older Patients) study is to identify patterns of chronic multimorbidity in a cohort of older patients and their progression and trajectories in the previous 10 years. METHODS: A retrospective, observational study with a cohort of 3988 patients aged > 65 was conducted, including suspected and confirmed COVID-19 patients in the reference area of Parc Taulí University Hospital. Real-world data on socio-demographic and diagnostic variables were retrieved. Multimorbidity patterns of chronic conditions were identified with fuzzy c-means cluster analysis. Trajectories of each patient were established along three time points (baseline, 5 years before, 10 years before). Descriptive statistics were performed together with a stratification by sex and age group. RESULTS: 3988 patients aged over 65 were included (58.9% females). Patients with ≥ 2 chronic conditions changed from 73.6 to 98.3% in the 10-year range of the study. Six clusters of chronic multimorbidity were identified 10 years before baseline, whereas five clusters were identified at both 5 years before and at baseline. Three clusters were consistently identified in all time points (Metabolic and vascular disease, Musculoskeletal and chronic pain syndrome, Unspecific); three clusters were only present at the earliest time point (Male-predominant diseases, Minor conditions and sensory impairment, Lipid metabolism disorders) and two clusters emerged 5 years before baseline and remained (Heart diseases and Neurocognitive). Sex and age stratification showed different distribution in cluster prevalence and trajectories. CONCLUSIONS: In a cohort of older patients, we were able to identify multimorbidity patterns of chronic conditions and describe their individual trajectories in the previous 10 years. Our results suggest that taking these trajectories into consideration might improve decisions in clinical management and healthcare planning. TRIAL REGISTRATION NUMBER: NCT05717309.

Five-year follow-up mortality prognostic index for colorectal patients.

PURPOSE: To identify 5-year survival prognostic variables in patients with colorectal cancer (CRC) and to propose a survival prognostic score that also takes into account changes over time in the patient's health-related quality of life (HRQoL) status. METHODS: Prospective observational cohort study of CRC patients. We collected data from their diagnosis, intervention, and at 1, 2, 3, and 5 years following the index intervention, also collecting HRQoL data using the EuroQol-5D-5L (EQ-5D-5L), European Organization for Research and Treatment of Cancer's Quality of Life Questionnaire-Core 30 (EORTC-QLQ-C30), and Hospital Anxiety and Depression Scale (HADS) questionnaires. Multivariate Cox proportional models were used. RESULTS: We found predictors of mortality over the 5-year follow-up to be being older; being male; having a higher TNM stage; having a higher lymph node ratio; having a result of CRC surgery classified as R1 or R2; invasion of neighboring organs; having a higher score on the Charlson comorbidity index; having an ASA IV; and having worse scores, worse quality of life, on the EORTC and EQ-5D questionnaires, as compared to those with higher scores in each of those questionnaires respectively. CONCLUSIONS: These results allow preventive and controlling measures to be established on long-term follow-up of these patients, based on a few easily measurable variables. IMPLICATIONS FOR CANCER SURVIVORS: Patients with colorectal cancer should be monitored more closely depending on the severity of their disease and comorbidities as well as the perceived health-related quality of life, and preventive measures should be established to prevent adverse outcomes and therefore to ensure that better treatment is received. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02488161.

Influence of depression on survival of colorectal cancer patients drawn from a large prospective cohort.

OBJECTIVE: The prevalence of depressive symptoms immediately after the diagnosis of colorectal cancer (CRC) is high and has important implications both psychologically and on the course of the disease. The aim of this study is to analyse the association between depressive symptoms and CRC survival at 5 years after diagnosis. METHODS: This multicentre, prospective, observational cohort study was conducted on a sample of 2602 patients with CRC who completed the Hospital Anxiety and Depression Scale (HADS-D) at 5 years of follow-up. Survival was analysed using the Kaplan-Meier method and Cox regression models. RESULTS: According to our analysis, the prevalence of depressive symptoms after a CRC diagnosis was 23.8%. The Cox regression analysis identified depression as an independent risk factor for survival (HR = 1.47; 95% CI: 1.21-1.8), a finding which persisted after adjusting for sex (female: HR = 0.63; 95% CI: 0.51-0.76), age (>70 years: HR = 3.78; 95% CI: 1.94-7.36), need for help (yes: HR = 1.43; 95% CI: 1.17-1.74), provision of social assistance (yes: HR = 1.46; 95% CI: 1.16-1.82), tumour size (T3-T4: HR = 1.56; 95% CI: 1.22-1.99), nodule staging (N1-N2: HR = 2.46; 95% CI: 2.04-2.96), and diagnosis during a screening test (yes: HR = 0.71; 95% CI: 0.55-0.91). CONCLUSIONS: There is a high prevalence of depressive symptoms in patients diagnosed with CRC. These symptoms were negatively associated with the survival rate independently of other clinical variables. Therefore, patients diagnosed with CRC should be screened for depressive symptoms to ensure appropriate treatment can be provided.

Mammographic features of benign breast lesions and risk of subsequent breast cancer in women attending breast cancer screening.

OBJECTIVES: To evaluate the mammographic features in women with benign breast disease (BBD) and the risk of subsequent breast cancer according to their mammographic findings. METHODS: We analyzed data from a Spanish cohort of women screened from 1995 to 2015 and followed up until December 2017 (median follow-up, 5.9 years). We included 10,650 women who had both histologically confirmed BBD and mammographic findings. We evaluated proliferative and nonproliferative BBD subtypes, and their mammographic features: architectural distortion, asymmetries, calcifications, masses, and multiple findings. The adjusted hazard ratios (aHR) and 95% confidence intervals (95% CI) for breast cancer were estimated using a Cox proportional hazards model. We plotted the adjusted cumulative incidence curves. RESULTS: Calcifications were more frequent in proliferative disease with atypia (43.9%) than without atypia (36.8%) or nonproliferative disease (22.2%; p value < 0.05). Masses were more frequent in nonproliferative lesions (59.1%) than in proliferative lesions without atypia (35.1%) or with atypia (30.0%; p value < 0.05). Multiple findings and architectural distortion were more likely in proliferative disease (16.1% and 4.7%) than in nonproliferative disease (12.8% and 1.9%). Subsequent breast cancer occurred in 268 (2.5%) women. Compared with women who had masses, the highest risk of subsequent breast cancer was found in those with architectural distortions (aHR, 2.21; 95% CI, 1.16-4.22), followed by those with multiple findings (aHR, 1.89; 95% CI, 1.34-2.66), asymmetries (aHR, 1.66; 95% CI, 0.84-3.28), and calcifications (aHR, 1.60; 95% CI, 1.21-2.12). CONCLUSION: BBD subtypes showed distinct mammographic findings. The risk of subsequent breast cancer was high in those who have shown architectural distortion, multiple findings, asymmetries, and calcifications than in women with masses. KEY POINTS: • The presence of mammographic findings in women attending breast cancer screening helps clinicians to assess women with benign breast disease (BBD). • Calcifications were frequent in BBDs with atypia, which are the ones with a high breast cancer risk, while masses were common in low-risk BBDs. • The excess risk of subsequent breast cancer in women with BBD was higher in those who showed architectural distortion compared to those with masses.

Anxiety, depression, health-related quality of life, and mortality among colorectal patients: 5-year follow-up.

PURPOSE: Health-related quality of life (HRQoL) measurement represents an important outcome in cancer patients. We describe the evolution of HRQoL over a 5-year period in colorectal cancer patients, identifying predictors of change and how they relate to mortality. METHODS: Prospective observational cohort study including colorectal cancer (CRC) patients having undergone surgery in nineteen public hospitals who were monitored from their diagnosis, intervention and at 1-, 2-, 3-, and 5-year periods thereafter by gathering HRQoL data using the EuroQol-5D-5L (EQ-5D-5L), European Organization for Research and Treatment of Cancer's Quality of Life Questionnaire-Core 30 (EORTC-QLQ-C30), and Hospital Anxiety and Depression Scale (HADS) questionnaires. Multivariable generalized linear mixed models were used. RESULTS: Predictors of Euroqol-5D-5L (EQ-5D-5L) changes were having worse baseline HRQoL; being female; higher Charlson index score (more comorbidities); complications during admission and 1 month after surgery; having a stoma after surgery; and needing or being in receipt of social support at baseline. For EORTC-QLQ-C30, predictors of changes were worse baseline EORTC-QLQ-C30 score; being female; higher Charlson score; complications during admission and 1 month after admission; receiving adjuvant chemotherapy; and having a family history of CRC. Predictors of changes in HADS anxiety were being female and having received adjuvant chemotherapy. Greater depression was associated with greater baseline depression; being female; higher Charlson score; having complications 1 month after intervention; and having a stoma. A deterioration in all HRQoL questionnaires in the previous year was related to death in the following year. CONCLUSIONS: These findings should enable preventive follow-up programs to be established for such patients in order to reduce their psychological distress and improve their HRQoL to as great an extent as possible. GOV IDENTIFIER: NCT02488161.

Factors associated to potentially inappropriate prescribing in older patients according to STOPP/START criteria: MoPIM multicentre cohort study.

OBJECTIVES: The objectives of the present analyses are to estimate the frequency of potentially inappropriate prescribing (PIP) at admission according to STOPP/START criteria version 2 in older patients hospitalised due to chronic disease exacerbation as well as to identify risk factors associated to the most frequent active principles as potentially inappropriate medications (PIMs). METHODS: A multicentre, prospective cohort study including older patients (≥65) hospitalized due to chronic disease exacerbation at the internal medicine or geriatric services of 5 hospitals in Spain between September 2016 and December 2018 was conducted. Demographic and clinical data was collected, and a medication review process using STOPP/START criteria version 2 was performed, considering both PIMs and potential prescribing omissions (PPOs). Primary outcome was defined as the presence of any most frequent principles as PIMs, and secondary outcomes were the frequency of any PIM and PPO. Descriptive and bivariate analyses were conducted on all outcomes and multilevel logistic regression analysis, stratified by participating centre, was performed on the primary outcome. RESULTS: A total of 740 patients were included (mean age 84.1, 53.2% females), 93.8% of them presenting polypharmacy, with a median of 10 chronic prescriptions. Among all, 603 (81.5%) patients presented at least one PIP, 542 (73.2%) any PIM and 263 (35.5%) any PPO. Drugs prescribed without an evidence-based clinical indication were the most frequent PIM (33.8% of patients); vitamin D supplement in older people who are housebound or experiencing falls or with osteopenia was the most frequent PPO (10.3%). The most frequent active principles as PIMs were proton pump inhibitors (PPIs) and benzodiazepines (BZDs), present in 345 (46.6%) patients. This outcome was found significantly associated with age, polypharmacy and essential tremor in an explanatory model with 71% AUC. CONCLUSIONS: PIMs at admission are highly prevalent in these patients, especially those involving PPIs or BZDs, which affected almost half of the patients. Therefore, these drugs may be considered as the starting point for medication review and deprescription. TRIAL REGISTRATION NUMBER: NCT02830425.

Effect of comorbidities on long-term outcomes of colorectal cancer patients.

OBJECTIVE: The objective of this work is to evaluate the association of comorbidities with various outcomes in patients diagnosed with colon or rectal cancer. METHODS: We conducted a prospective cohort study of patients diagnosed with colon or rectal cancer who underwent surgery. Data were gathered on sociodemographic, clinical characteristics, disease course, and the EuroQol EQ-5D and EORTC QLQ-C30 scores, up to 5 years after surgery. The main outcomes of the study were mortality, complications, readmissions, reoperations, and changes in PROMs up to 5 years. Multivariable multilevel logistic regression models were used in the analyses. RESULTS: Mortality at some point during the 5-year follow-up was related to cardiocerebrovascular, hemiplegia and/or stroke, chronic obstructive pulmonary disease (COPD), diabetes, cancer, and dementia. Similarly, complications were related to cardiovascular disease, COPD, diabetes, hepatitis, hepatic or renal pathologies, and dementia; readmissions to cardiovascular disease, COPD, and hepatic pathologies; and reoperations to cerebrovascular and diabetes. Finally, changes in EQ-5D scores at some point during follow-up were related to cardiocerebrovascular disease, COPD, diabetes, pre-existing cancer, hepatic and gastrointestinal pathologies, and changes in EORTC QLQ-C30 scores to cardiovascular disease, COPD, diabetes, and hepatic and gastrointestinal pathologies. CONCLUSIONS: Optimising the management of the comorbidities most strongly related to adverse outcomes may help to reduce those events in these patients.

Factors that Influence Treatment Delay for Patients with Breast Cancer.

INTRODUCTION: The diagnosis or treatment of breast cancer is sometimes delayed. A lengthy delay may have a negative psychological impact on patients. The aim of our study was to evaluate the sociodemographic, clinical and pathological factors associated with delay in the provision of surgical treatment for localised breast cancer, in a prospective cohort of patients. METHODS: This observational, prospective, multicentre study was conducted in ten hospitals belonging to the Spanish national public health system, located in four Autonomous Communities (regions). The study included 1236 patients, diagnosed through a screening programme or found to be symptomatic, between April 2013 and May 2015. The study variables analysed included each patient's personal history, care situation, tumour history and data on the surgical intervention, pathological anatomy, hospital admission and follow-up. Treatment delay was defined as more than 30 days elapsed between biopsy and surgery. RESULTS: Over half of the study population experienced surgical treatment delay. This delay was greater for patients with no formal education and among widows, persons not requiring assistance for usual activities, those experiencing anxiety or depression, those who had a high BMI or an above-average number of comorbidities, those who were symptomatic, who did not receive NMR spectroscopy, who presented a histology other than infiltrating ductal carcinoma or who had poorly differentiated carcinomas. CONCLUSIONS: Certain sociodemographic and clinical variables are associated with surgical treatment delay. This study identifies factors that influence surgical delays, highlighting the importance of preventing these factors and of raising awareness among the population at risk and among health personnel.

Risk scores to predict mortality 2 and 5 years after surgery for colorectal cancer in elderly patients.

BACKGROUND: The aim of this study was to identify predictors of mortality in elderly patients undergoing colorectal cancer surgery and to develop a risk score. METHODS: This was an observational prospective cohort study. Individuals over 80 years diagnosed with colorectal cancer and treated surgically were recruited in 18 hospitals in the Spanish National Health Service, between June 2010 and December 2012, and were followed up 1, 2, 3, and 5 years after surgery. Sociodemographic and clinical data were collected. The primary outcomes were mortality at 2 and between 2 and 5 years after the index admission. RESULTS: The predictors of mortality 2 years after surgery were haemoglobin ≤ 10 g/dl and colon locations (HR 1.02; CI 0.51-2.02), ASA class of IV (HR 3.55; CI 1.91-6.58), residual tumour classification of R2 (HR 7.82; CI 3.11-19.62), TNM stage of III (HR 2.14; CI 1.23-3.72) or IV (HR 3.21; CI 1.47-7), LODDS of more than - 0.53 (HR 3.08; CI 1.62-5.86)) and complications during admission (HR 1.73; CI 1.07-2.80). Between 2 and 5 years of follow-up, the predictors were no tests performed within the first year of follow-up (HR 2.58; CI 1.21-5.46), any complication due to the treatment within the 2 years of follow-up (HR 2.47; CI 1.27-4.81), being between 85 and 89 and not having radiotherapy within the second year of follow-up (HR 1.60; CI 1.01-2.55), no colostomy closure within the 2 years of follow-up (HR 4.93; CI 1.48-16.41), medical complications (HR 1.61; CI 1.06-2.44), tumour recurrence within the 2 years of follow-up period (HR 3.19; CI 1.96-5.18), and readmissions at 1 or 2 years of follow-up after surgery (HR 1.44; CI 0.86-2.41). CONCLUSION: We have identified variables that, in our sample, predict mortality 2 and between 2 and 5 years after surgery for colorectal cancer older patients. We have also created risks scores, which could support the decision-making process. TRIAL REGISTRATION: ClinicalTrials.gov , NCT02488161 .

Gender differences in stage at diagnosis and preoperative radiotherapy in patients with rectal cancer.

BACKGROUND: Few studies have examined gender differences in the clinical management of rectal cancer. We examine differences in stage at diagnosis and preoperative radiotherapy in rectal cancer patients. METHODS: A prospective cohort study was conducted in 22 hospitals in Spain including 770 patients undergoing surgery for rectal cancer. Study outcomes were disseminated disease at diagnosis and receiving preoperative radiotherapy. Age, comorbidity, referral from a screening program, diagnostic delay, distance from the anal verge, and tumor depth were considered as factors that might explain gender differences in these outcomes. RESULTS: Women were more likely to be diagnosed with disseminated disease among those referred from screening (odds ratio, confidence interval 95% (OR, CI = 7.2, 0.9-55.8) and among those with a diagnostic delay greater than 3 months (OR, CI = 5.1, 1.2-21.6). Women were less likely to receive preoperative radiotherapy if they were younger than 65 years of age (OR, CI = 0.6, 0.3-1.0) and if their tumors were cT3 or cT4 (OR, CI = 0.5, 0.4-0.7). CONCLUSIONS: The gender-specific sensitivity of rectal cancer screening tests, gender differences in referrals and clinical reasons for not prescribing preoperative radiotherapy in women should be further examined. If these gender differences are not clinically justifiable, their elimination might enhance survival.

Predictors of readmission and reoperation in patients with colorectal cancer.

PURPOSE: To assess the impact of readmission and reoperation on colon or rectal cancer patients in clinical and patient-reported outcome measures (PROMs) and to identify predictors of these events up to 1 year after surgery. METHODS: Prospective cohort study of patients diagnosed with colon or rectal cancer who underwent surgery at 1 of 22 hospitals. Medical history, clinical parameters, and PROMs were evaluated as possible predictors. Multivariable multilevel logistic regression and survival models were used in the analyses to create the clinical prediction rules. Models were developed in a derivation sample and validated in a different sample. RESULTS: Readmission and reoperation were related to clinical outcomes and changes in some PROMs. Predictors of readmission in colon cancer were ASA class (odds ratio (OR) 4.5), TNM (OR for TNM III 3.24, TNM IV 4.55), evidence of residual tumor (R2) (OR 3.96), and medical (OR 1.96) and infectious (OR 2.01) complications within 30 days after surgery, while for rectal cancer, the predictors identified were age (OR 1.03), R2 (OR 6.48), infectious complications within 30 days (OR 2.29), hemoglobin (OR 3.26), lymph node ratio (OR 2.35), and surgical complications within 1 month (OR 3.04). Predictors of reoperation were TNM IV (OR 5.06), surgical complications within 30 days (OR 1.98), and type and site of tumor (OR 1.72) in colon cancer and being male (OR 1.52), age (OR 1.80), stoma (OR 1.87), and surgical complications within 1 month (OR 1.95) in rectal cancer. CONCLUSIONS: Our clinical prediction rule models are easy to use and could help to develop and implement interventions to reduce preventable readmissions and reoperations. TRIAL REGISTRATION: https://clinicaltrials.gov/ct2/show/NCT02488161 Identifier: NCT02488161.

Stage- and age-adjusted cost-effectiveness analysis of laparoscopic surgery in rectal cancer.

BACKGROUND: It has been argued that laparoscopy should be a standard treatment in rectal cancer due to its greater technical complexity. The objective of this study was to conduct a cost-effectiveness analysis to compare laparoscopy with open surgery for rectal cancer adjusting for age and clinical stage. METHODS: A real-world prospective cost-effectiveness cohort study was conducted with data on costs and effectiveness at individual patient level. A "genetic matching" algorithm was used to correct for selection bias. After balancing the sample groups, combined multivariate analysis of total costs and quality-adjusted life years (QALYs) was performed using seemingly unrelated regression (SUR) models. These models were first constructed without interactions and, subsequently, effects of any age-stage interaction were analyzed. RESULTS: The sample included 601 patients (400 by laparoscopy and 201 by open surgery). Crude cost-effectiveness analysis indicated that overall laparoscopy was cheaper and associated with higher QALYs. The SUR models without interactions showed that while laparoscopy remained dominant, the incremental effectiveness decreased to the point that it offered no statistically significant benefits over open surgery. In the subgroup analysis, at advanced stages of the disease, although none of the coefficients were significant, the mean incremental effectiveness (QALYs value) for laparoscopy was positive in younger patients and negative in older patients. Further, for advanced stages, the mean cost of open surgery was lower in both age subgroups but differences did not reach statistical significance. In early stages, laparoscopy cost was significantly lower in the subgroup younger than 70 and higher in the older subgroup. CONCLUSIONS: The cost-effectiveness of laparoscopy in surgery for rectal cancer justifies this being the standard surgical procedure in young patients and those at initial stages. The choice of procedure should be discussed with patients who are older and/or in advanced stages of the disease. Trial registration ClinicalTrials.gov Identifier: NCT02488161.

Factors associated with colon cancer early, intermediate and late recurrence after surgery for stage I-III: A 5-year prospective study.

OBJECTIVE: To identify factors associated with early, intermediate or late recurrence colon cancer recurrence. METHODS: A total of 1,732 consecutive patients with colon cancer were recruited and followed for a period of 5 years. Recurrence at 1 year (early), from 1 to 2 (early), from 2 to 3 (intermediate) and from 3 to 5 years (late) was the main outcome measures. RESULTS: Predictors of early recurrence (AUC (95% CI):0.74 (0.70-0.78) were as follows: TNM stage II and III, more than one type of invasion, haemoglobin <10 g/dl, residual tumour (R1), ASA IV, log odds of positive lymph nodes ratio ≥-0.53, perforation, neoadjuvant chemotherapy, infectious complications within 1 year and CEA pre- and post-intervention. These factors remained significant for predicting intermediate (AUC [95% CI]: 0.72 [0.67-0.77]) and late (AUC [95% CI]: 0.68 [0.63-0.74]) recurrence, except for ASA class, log lymph node ratio, perforation and neoadjuvant chemotherapy. Additionally, laterality (left) and medical complications up to 2 years were significant. CONCLUSIONS: These risk factors show good predictive ability of early, intermediate and late recurrence, confirming factors established by guidelines and adding some others. They could serve to provide more appropriate and accurate treatment and follow-up tailored to patient characteristics.

Risk factors affecting hospital stay among patients undergoing colon cancer surgery: a prospective cohort study.

PURPOSE: To identify and validate risk factors that contribute to prolonged length of hospital stay (LOS) in patients undergoing resection for colorectal cancer. METHODS: This prospective cohort study included 1955 patients admitted to 22 hospitals for primary resection of colorectal cancer. Multivariate analyses were used to identify and validate risk factors, randomizing patients into a derivation and a validation cohort. Multiple correspondence and cluster analysis were performed to identify clinical subtypes based on LOS. RESULTS: The strongest independent predictors of prolonged LOS were postoperative reintervention, surgical site infection, open surgery, and distant metastasis. The multiple correspondence and cluster analysis provided three groups of patients in relation to prolonged LOS: patients with the longest LOS included the highest percentage of patients with open surgery, distant metastasis, deep surgical site infections, emergency admissions, additional diagnostic factors, and highly contaminated surgical sites. Patients with prolonged LOS (> 14 days) were more likely to develop adverse outcomes within 30 days after discharge. CONCLUSIONS: Patients undergoing resection of colorectal cancer cluster into different groups based on LOS of the index admission. Those with prolonged LOS were more likely to develop adverse outcomes within 30 days after discharge. Some of the strongest independent predictors of prolonged LOS, such as surgical infections or open surgery, could be modified to reduce LOS and, in turn, other adverse outcomes. TRIAL REGISTRATION: NCT02488161.

Factors associated with readmissions in women participating in screening programs and treated for breast cancer: a retrospective cohort study.

BACKGROUND: We aimed to identify the risk factors associated with early, late and long-term readmissions in women diagnosed with breast cancer participating in screening programs. METHODS: We performed a multicenter cohort study of 1055 women aged 50-69 years participating in Spanish screening programs, diagnosed with breast cancer between 2000 and 2009, and followed up to 2014. Readmission was defined as a hospital admission related to the disease and/or treatment complications, and was classified as early (< 30 days), late (30 days-1 year), or long-term readmission (> 1 year). We used logistic regression to estimate the adjusted odds ratios (aOR), and 95% confidence intervals (95% CI) to explore the factors associated with early, late and long-term readmissions, adjusting by women's and tumor characteristics, detection mode, treatments received, and surgical and medical complications. RESULTS: Among the women included, early readmission occurred in 76 (7.2%), late readmission in 87 (8.2%), long-term readmission in 71 (6.7%), and no readmission in 821 (77.8%). Surgical complications were associated with an increased risk of early readmissions (aOR = 3.62; 95%CI: 1.27-10.29), and medical complications with late readmissions (aOR = 8.72; 95%CI: 2.83-26.86) and long-term readmissions (aOR = 4.79; 95%CI: 1.41-16.31). CONCLUSION: Our results suggest that the presence of surgical or medical complications increases readmission risk, taking into account the detection mode and treatments received. Identifying early complications related to an increased risk of readmission could be useful to adapt the management of patients and reduce further readmissions. TRIAL REGISTRATION: ClinicalTrials.govIdentifier: NCT03165006. Registration date: May 22, 2017 (Retrospectively registered).

Outcomes of open versus laparoscopic surgery in patients with rectal cancer.

PURPOSE: The goal of this study was to compare the effectiveness of laparoscopic with that of open surgery up to 2 years after intervention in patients with rectal cancer. METHODS: This is a prospective cohort study of patients with rectal cancer who underwent surgery (laparoscopic or open) between June 2010 and December 2012 in 22 acute hospitals. Main outcomes were mortality, complications, reoperation, readmission, and patient-reported outcome measures (PROMs), as measured using the EuroQol-5D (EQ-5D), European Organisation for Research and Treatment of Cancer (EORTC) QLQ-Q30 and Q29, the Barthel Index (BI), and the Duke-UNC Functional Social Support Questionnaire at baseline, 1 year, and 2 years after surgery. Multivariable multilevel logistic regression and generalized linear models were used in the analyses after adjusting for specific propensity scores developed for each outcome and time point. RESULTS: In the multivariable analysis, rates of some medical complications after surgery during admission (renal failure and paralytic ileus) and infectious (urinary tract infection, septic shock, and localized intra-abdominal infection) and at 1 year (renal and heart failure) were higher among patients who underwent open surgery than among those who underwent laparoscopic surgery. There were no differences between the two surgical approaches in all other parameters assessed at the different time points or in all PROMs evaluated. CONCLUSIONS: Laparoscopic surgery and open surgery provide quite similar results in patients with rectal cancer up to 2 years after intervention in most outcomes, though the rates of certain medical and infectious complications at admission and up to 1 year after the intervention were higher in open surgery.

Cost-effectiveness analysis of laparoscopic versus open surgery in colon cancer.

BACKGROUND: Few economic evaluations have assessed laparoscopy for colon cancer. This study aimed to compare the cost-effectiveness of laparoscopic and open surgery for the treatment of colon cancer. METHOD: A cost-effectiveness analysis was performed comparing two groups of patients treated according to standard clinical practice (REDISSEC-CARESS/CCR cohort) by laparoscopic or open surgery. Data were collected from health records on clinical characteristics and resource use over 2 years after surgery. To calculate the incremental cost-effectiveness ratio, costs and quality-adjusted life years (QALYs) were obtained for each patient. Clinical heterogeneity was addressed using propensity score and joint multivariable analysis (seemingly unrelated regression) that included interactions between TNM stage, age, and surgical procedure to perform subgroup analysis. RESULTS: The sample was composed of 1591 patients, 963 who underwent laparoscopy and 628 open surgery. Using propensity score and regression analysis, we found that laparoscopy was associated with more QALYs and less resource use than open surgery (0.0163 QALYs, 95% CI 0.0114-0.0212; and - €3461, 95% CI - 3337 to - 3586). Costs were lower for laparoscopy in all subgroups. In the subgroups younger than 80 years old, utility was higher in patients who underwent laparoscopy. Nevertheless, open surgery had better outcomes in older patients in stages I-II (0.0618 QALYs) and IV (0.5090 QALYs). CONCLUSION: Overall, laparoscopy appears to be dominant, resulting in more QALYs and lower costs. Nevertheless, while laparoscopy required fewer resources in all subgroups, outcomes may be negatively affected in elderly patients, representing an opportunity for shared decision making between surgeons and patients. ClinicalTrials.gov Identifier: NCT02488161.

Clinical and histologic characteristics of breast cancers in women with previous pathologic diagnosis of benign breast disease in Spain.

Women with a benign breast disease (BBD) have an increased risk of subsequent breast carcinoma. Information is scarce regarding the characteristics of breast carcinomas diagnosed after a BBD. Our aim was to point out the differences in clinical and histologic characteristics of breast carcinomas diagnosed in women with and without a previous pathologic diagnosis of BBD in the context of population-based mammography screening. Retrospective cohort study of all women aged 50-69 years who were screened at least once in a population-based screening program in Spain, between 1994 and 2011 and followed up until December 2012. The mean follow-up was 6.1 years. We analyzed 6645 breast carcinomas, of whom 238 had a previous pathologic diagnosis of BBD. Information on clinical and histologic characteristics was collected from pathology reports. Logistic regression was used to estimate the odds ratio (OR) and 95% confidence intervals (95%CI) of occurrence of selected histologic characteristics of breast carcinomas in women with and without a previous BBD. Women with a previous BBD had a higher proportion of ductal carcinoma in situ (DCIS) compared with women without a BBD (22.1% and 13.6%, respectively). Among those diagnosed with an invasive breast carcinoma, women with previous BBD were more likely to be diagnosed with carcinomas sized >2 cm (OR = 1.46; 95%CI = 1.03-2.08), metastatic positive (OR = 2.66; 95%CI = 1.21-5.86), and with a high Ki-67 proliferation rate (OR = 1.93; 95%CI = 1.24-2.99). No differences were found across histologic subtypes of BBD. Screening participants with a previous pathologic diagnosis of BBD had a higher proportion of DCIS. However, invasive carcinomas detected in women with a BBD were associated with clinical and histologic characteristics conferring a worst prognosis.

Validity of the CR-POSSUM model in surgery for colorectal cancer in Spain (CCR-CARESS study) and comparison with other models to predict operative mortality.

BACKGROUND: To validate and recalibrate the CR- POSSUM model and compared its discriminatory capacity with other European models such as POSSUM, P-POSSUM, AFC or IRCS to predict operative mortality in surgery for colorectal cancer. METHODS: Prospective multicenter cohort study from 22 hospitals in Spain. We included patients undergoing planned or urgent surgery for primary invasive colorectal cancers between June 2010 and December 2012 (N = 2749). Clinical data were gathered through medical chart review. We validated and recalibrated the predictive models using logistic regression techniques. To calculate the discriminatory power of each model, we estimated the areas under the curve - AUC (95% CI). We also assessed the calibration of the models by applying the Hosmer-Lemeshow test. RESULTS: In-hospital mortality was 1.5% and 30-day mortality, 1.7%. In the validation process, the discriminatory power of the CR-POSSUM for predicting in-hospital mortality was 73.6%. However, in the recalibration process, the AUCs improved slightly: the CR-POSSUM reached 75.5% (95% CI: 67.3-83.7). The discriminatory power of the CR-POSSUM for predicting 30-day mortality was 74.2% (95% CI: 67.1-81.2) after recalibration; among the other models the POSSUM had the greatest discriminatory power, with an AUC of 77.0% (95% CI: 68.9-85.2). The Hosmer-Lemeshow test showed good fit for all the recalibrated models. CONCLUSION: The CR-POSSUM and the other models showed moderate capacity to discriminate the risk of operative mortality in our context, where the actual operative mortality is low. Nevertheless the IRCS might better predict in-hospital mortality, with fewer variables, while the CR-POSSUM could be slightly better for predicting 30-day mortality. TRAIL REGISTRATION: Registered at: ClinicalTrials.gov Identifier: NCT02488161.