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1.
Dis Colon Rectum ; 67(1): 32-41, 2024 Jan 01.
Artículo en Inglés | MEDLINE | ID: mdl-37787557

RESUMEN

BACKGROUND: Targeted screening programs for patients at high risk for anal squamous-cell carcinoma have been proposed; however, the evidence in support of screening remains unclear. OBJECTIVE: This study aimed to determine whether screening high-risk patients (predominantly those living with HIV) detected squamous-cell carcinoma at an earlier stage compared to the routine practice of not screening. DESIGN: This is a cohort study. SETTINGS: This study was conducted at a quaternary care center in Canada. PATIENTS: Included patients were at least 18 years old with a pathologic diagnosis of invasive anal squamous-cell carcinoma between 2002 and 2022. INTERVENTIONS: Patients diagnosed through a high-risk screening program were compared to those who did not undergo screening. MAIN OUTCOME MEASURES: The primary outcome was clinical stage at presentation, categorized as T1N0M0 vs other. Secondary outcomes included treatments received, treatment failure, and overall survival. RESULTS: A total of 612 patients with anal squamous-cell carcinoma were included, with 26 of those patients diagnosed through a screening program. Patients with screen-detected cancers had greater odds of presenting with T1N0M0 tumors compared to unscreened patients (18 [69.2%] vs 84 [14.3%]; adjusted OR 9.95; 95% CI, 3.95-25.08). A propensity score-matched sensitivity analysis found similar results (OR 11.13; 95% CI, 4.67-26.52). Screened patients had greater odds of treatment with wide local excision alone, as opposed to any combination of chemotherapy, radiation therapy, and surgery (3 [12.5%] vs 18 [3.2%]; OR 4.38; 95% CI, 1.20-16.04). There were no statistically significant differences in treatment failure or overall survival between groups. LIMITATIONS: The small number of screened patients limits the power of the analysis. CONCLUSIONS: Screening for anal squamous-cell carcinoma among high-risk populations detects cancers at an earlier stage. Patients with screen-detected cancers also had a greater likelihood of being candidates for wide local excision alone, which may have spared them the morbidity associated with chemoradiotherapy or abdominoperineal resection. See Video Abstract. CNCERES DE ANO EN PACIENTES PREVIAMENTE DETECTADOS POR CRIBADO VERSUS NO DETECTADOS ESTADIO DEL TUMOR Y RESULTADOS DEL TRATAMIENTO: ANTECEDENTES:Se han propuesto programas de cribado dirigidos a pacientes con alto riesgo de carcinoma anal de células escamosas; sin embargo, la evidencia a favor de la detección sigue sin estar clara.OBJETIVO:Este estudio tuvo como objetivo determinar si el cribado de pacientes de alto riesgo (predominantemente aquellos que viven con el VIH) detectó el carcinoma de células escamosas en una etapa más temprana en comparación con la práctica habitual de no cribado.DISEÑO:Este es un estudio de cohortes.CONFIGURACIÓN:Este estudio se realizó en un centro de atención cuaternaria en Canadá.PACIENTES:Los pacientes incluidos tenían al menos 18 años con un diagnóstico patológico de carcinoma de células escamosas anal invasivo entre 2002 y 2022.INTERVENCIONES:Los pacientes diagnosticados mediante un programa de cribado de alto riesgo se compararon con aquellos que no se sometieron a cribado.PRINCIPALES MEDIDAS DE RESULTADO:El resultado primario fue el estadio clínico en la presentación, categorizado como T1N0M0 versus otro. Los resultados secundarios incluyeron los tratamientos recibidos, el fracaso del tratamiento y la supervivencia general.RESULTADOS:Se incluyeron un total de 612 pacientes con carcinoma anal de células escamosas, con 26 de esos pacientes diagnosticados a través de un programa de cribado. Los pacientes con cánceres detectados mediante cribado tenían mayores probabilidades de presentar tumores T1N0M0 en comparación con los pacientes no cribados (18 [69.2%] frente a 84 [14.3%]; razón de probabilidad ajustada 9.95; intervalo de confianza del 95 % 3.95 -25.08). Un análisis de sensibilidad emparejado por puntaje de propensión encontró resultados similares (odds ratio 11.13; intervalo de confianza del 95% 4.67 -26.52; p < 0.001). Los pacientes examinados tenían mayores probabilidades de recibir tratamiento con escisión local amplia sola, en comparación con cualquier combinación de quimioterapia, radiación y cirugía (3 [12.5%] frente a 18 [3.2%]; razón de probabilidad 4.38; intervalo de confianza del 95 % 1.20 -16.04). No hubo diferencias estadísticamente significativas en el fracaso del tratamiento o la supervivencia global entre los grupos.LIMITACIONES:El pequeño número de pacientes evaluados limita el poder del análisis.CONCLUSIONES:La detección del carcinoma anal de células escamosas entre las poblaciones de alto riesgo detecta los cánceres en una etapa más temprana. Los pacientes con cánceres detectados mediante cribado también tenían una mayor probabilidad de ser candidatos para una escisión local amplia sola, lo que puede haberles evitado la morbilidad asociada con la quimiorradioterapia o la resección abdominoperineal. (Traducción --Dr. Aurian Garcia Gonzalez ).


Asunto(s)
Neoplasias del Ano , Carcinoma de Células Escamosas , Neoplasias del Recto , Humanos , Adolescente , Estudios Retrospectivos , Estudios de Cohortes , Resultado del Tratamiento , Neoplasias del Ano/diagnóstico , Neoplasias del Ano/terapia , Neoplasias del Ano/patología , Carcinoma de Células Escamosas/diagnóstico , Carcinoma de Células Escamosas/terapia , Carcinoma de Células Escamosas/patología , Estadificación de Neoplasias , Neoplasias del Recto/patología
2.
Ann Surg ; 277(2): 291-298, 2023 02 01.
Artículo en Inglés | MEDLINE | ID: mdl-34417359

RESUMEN

OBJECTIVE: We sought to compare long-term healthcare dependency and time-at-home between older adults undergoing minimally invasive surgery (MIS) for colorectal cancer (CRC) and those undergoing open resection. BACKGROUND: Although the benefits of MIS for CRC resection are established, data specific to older adults are lacking. Long-term functional outcomes, central to decision-making in the care for older adults, are unknown. METHODS: We performed a population-based analysis of patients ≥70years old undergoing CRC resection between 2007 to 2017 using administrative datasets. Outcomes were receipt of homecare and "high" time-at-home, which we defined as years with ≤14 institution-days, in the 5years after surgery. Homecare was analyzed using time-to-event analyses as a recurrent dichotomous outcome with Andersen-Gill multivariable models. High timeat-home was assessed using Cox multivariable models. RESULTS: Of 16,479 included patients with median follow-up of 4.3 (interquartile range 2.1-7.1) years, 7822 had MIS (47.5%). The MIS group had lower homecare use than the open group with 22.3% versus 31.6% at 6 months and 14.8% versus 19.4% at 1 year [hazard ratio 0.87,95% confidence interval (CI) 0.83-0.92]. The MIS group had higher probability ofhigh time-at-home than open surgery with 54.9% (95% CI 53.6%-56.1%) versus 41.2% (95% CI 40.1%-42.3%) at 5years (hazard ratio 0.71, 95% CI 0.68-0.75). CONCLUSIONS: Compared to open surgery, MIS for CRC resection was associated with lower homecare needs and higher probability of high time-at-home in the 5 years after surgery, indicating reduced long-term functional dependence. These are important patient-centered endpoints reflecting the overall long-term treatment burden to be taken into consideration in decision-making.


Asunto(s)
Neoplasias Colorrectales , Procedimientos Quirúrgicos Mínimamente Invasivos , Humanos , Anciano , Modelos de Riesgos Proporcionales , Neoplasias Colorrectales/cirugía , Estudios Retrospectivos , Resultado del Tratamiento
3.
Ann Surg ; 278(2): e368-e376, 2023 08 01.
Artículo en Inglés | MEDLINE | ID: mdl-35968895

RESUMEN

OBJECTIVE: To examine long-term healthcare dependency outcomes of stereotactic body radiation therapy (SBRT) to surgery for older adults with stage I non-small cell lung cancer (NSCLC). BACKGROUND: SBRT is an emerging alternative to surgery in patients with early-stage lung cancer. There remains a paucity of prospective studies comparing these modalities, especially with respect to long-term dependency outcomes in older adults with lung cancer. METHODS: Adults 70 years old and above with stage I NSCLC treated with surgery or SBRT from January 2010 to December 2017 were analyzed using 1:1 propensity score matching. Homecare use, days at home, and time spent alive and at home were compared. E-value methods assessed residual confounding. RESULTS: A total of 1129 and 2570 patients underwent SBRT and surgery, respectively. In all, 1016 per group were matched. SBRT was associated with a higher overall risk of homecare utilization [hazard ratio (HR)=1.75, 95% confidence interval (CI): 1.37-2.23] than surgery up to 5 years following treatment. While the hazards of death or nursing home admission were lower in the first 3 months after SBRT (HR=0.55, 95% CI: 0.36-0.85), they became consistently higher beyond this period and remained high up to 5 years compared with surgery (HR=2.13; 95% CI: 1.85-2.45). The above findings persisted in stratified analyses for frail patients and those with no pretreatment homecare. E-values indicated it was unlikely that the observed estimates could be explained by unmeasured confounders. CONCLUSIONS: Surgery offers robust long-term dependency outcomes compared with SBRT. These are important patient-centered endpoints which may be used for counseling and shared decision-making in older adults with stage I NSCLC.


Asunto(s)
Carcinoma de Pulmón de Células no Pequeñas , Neoplasias Pulmonares , Radiocirugia , Humanos , Anciano , Carcinoma de Pulmón de Células no Pequeñas/radioterapia , Carcinoma de Pulmón de Células no Pequeñas/cirugía , Carcinoma de Pulmón de Células no Pequeñas/patología , Neoplasias Pulmonares/radioterapia , Neoplasias Pulmonares/cirugía , Neoplasias Pulmonares/patología , Radiocirugia/métodos , Estudios Prospectivos , Estadificación de Neoplasias , Estudios Retrospectivos , Resultado del Tratamiento
4.
Ann Surg Oncol ; 30(2): 694-708, 2023 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-36068425

RESUMEN

BACKGROUND: Older adults have unique needs for supportive care after surgery. We examined symptom trajectories and factors associated with high symptom burden after cancer surgery in older adults. PATIENTS AND METHODS: We conducted a population-level study of patients ≥ 70 years old undergoing cancer surgery (2007-2018) using prospectively collected Edmonton Symptom Assessment System (ESAS) scores. The monthly prevalence of moderate to severe symptoms (ESAS ≥ 4) for anxiety, depression, drowsiness, lack of appetite, nausea, pain, shortness of breath, tiredness, and poor wellbeing was computed over 12 months after surgery. RESULTS: Among 48,748 patients, 234,420 ESAS scores were recorded over 12 months after surgery. Moderate to severe tiredness (57.8%), poor wellbeing (51.9%), and lack of appetite (39.3%) were most common. The proportion of patients with moderate to severe symptoms was stable over the 1 month prior to and 12 months after surgery (< 5% variation for each symptom). There was no clinically significant change (< 5%) in symptom trajectory with the initiation of adjuvant therapy. CONCLUSIONS: Patient-reported symptom burden was stable for up to 1 year after cancer surgery among older adults. Neither surgery nor adjuvant therapy coincided with a worsening in symptom burden. However, the persistence of symptoms at 1 year may suggest gaps in supportive care for older adults. This information on symptom trajectory and predictors of high symptom burden is important to set appropriate expectations and improve patient counseling, recovery care pathways, and proactive symptom management for older adults after cancer surgery.


Asunto(s)
Neoplasias , Cuidados Paliativos , Humanos , Anciano , Dolor/diagnóstico , Ansiedad/epidemiología , Ansiedad/etiología , Ansiedad/diagnóstico , Neoplasias/cirugía , Medición de Resultados Informados por el Paciente
5.
Crit Care ; 27(1): 162, 2023 04 25.
Artículo en Inglés | MEDLINE | ID: mdl-37098625

RESUMEN

BACKGROUND: Older adults are at high-risk for a post-operative intensive care unit (ICU) admission, yet little is known about the impact of these admissions on quality of life. The objective of this study was to evaluate the impact of an unexpected post-operative ICU admission on the burden of cancer symptoms among older adults who underwent high-intensity cancer surgery and survived to hospital discharge. METHODS: We performed a population-based cohort study of older adults (age ≥ 70) who underwent high-intensity cancer surgery and survived to hospital discharge in Ontario, Canada (2007-2017). Using the Edmonton Symptom Assessment System (ESAS), a standardized tool that quantifies patient-reported physical, mental, and emotional symptoms, we described the burden of cancer symptoms during the year after surgery. Total symptom scores ≥ 40 indicated a moderate-to-severe symptom burden. Modified log-Poisson analysis was used to estimate the impact of an unexpected post-operative ICU admission (admission not related to routine monitoring) on the likelihood of experiencing a moderate-to-severe symptom burden during the year after surgery, accounting for potential confounders. We then used multivariable generalized linear mixed models to model symptom trajectories among patients with two or more ESAS assessments. A 10-point difference in total symptom scores was considered clinically significant. RESULTS: Among 16,560 patients (mean age 76.5 years; 43.4% female), 1,503 (9.1%) had an unexpected ICU admission. After accounting for baseline characteristics, patients with an unexcepted ICU admission were more likely to experience a moderate-to-severe symptom burden relative to those without an unexpected ICU admission (RR 1.64, 95% CI 1.31-2.05). Specifically, among patients with an unexcepted ICU admission the average probability of experiencing moderate-to-severe symptoms ranged from 6.9% (95 CI 5.8-8.3%) during the first month after surgery to 3.2% (95% CI 0.9-11.7%) at the end of the year. Among the 11,229 (67.8%) patients with multiple ESAS assessments, adjusted differences in total scores between patients with and without an unexpected ICU admission ranged from 2.0 to 5.7-points throughout the year (p < 0.001). CONCLUSION: While unexpected ICU admissions are associated with a small increase in the likelihood of experiencing a moderate-to-severe symptom burden, most patients do not experience a high overall symptom burden during the year after surgery. These findings support the role of aggressive therapy among older adults after major surgery.


Asunto(s)
Neoplasias , Calidad de Vida , Humanos , Femenino , Anciano , Masculino , Estudios de Cohortes , Hospitalización , Unidades de Cuidados Intensivos , Ontario/epidemiología , Neoplasias/cirugía
6.
Ann Surg ; 276(6): e851-e860, 2022 12 01.
Artículo en Inglés | MEDLINE | ID: mdl-33914463

RESUMEN

OBJECTIVE: To evaluate healthcare dependency following hepatopancreato-biliary cancer surgery in older adults (OA). SUMMARY BACKGROUND DATA: Functional outcomes are central to decisionmaking by OA, but long-term risks of dependency have not been described beyond 1 year in this population. METHODS: All patients over age 70 undergoing hepatectomy or pancreatec-tomy for cancer between 2007 and 2017 in Ontario were analyzed. Outcomes were 1) receipt of homecare and 2) time at home. Homecare was analyzed with cumulative incidence functions, and time at home with Kaplan-Meier and Cox multivariate models. RESULTS: A total of 902 and 1283 patients underwent hepatectomy and pancreatectomy, respectively. Homecare use was highest (72.3%) in postoperative month-1, decreasing to stabilize between year-1 (25.5%) and year-5 (18.3%). Repeated receipt of homecare was associated with female sex (HR 1.18, 95% CI 1.05-1.32), receipt of adjuvant therapy (HR 1.56, 1.37-1.78), and more recent year of surgery (HR 3.80, 3.05-4.72). The ratio of home nursing care versus personal support services reversed from 68%/26% in year-1, to 29/64% in year-5. High time at home (>350 days) at 1 and 5 years were 40.6% (95% CI 38.5%-42.6%) and 28.1% (25.9%-30.3%), respectively. The ratio of institution-days in acute care versus nursing homes went from 77%/14% in year-1 to 23%/70% in year-5. Low time at home was associated with duodenal (HR 1.45, 1.15-1.70) and pancreas cancer (HR 1.20, 1.02-1.42), and with rural residence (HR 1.24, 1.04-1.48). High time at home was associated with more recent year of surgery (HR 0.84, 0.76-0.93) and perioperative cancer therapy (HR 0.88, 0.78-0.99). Increasing age was neither associated with homecare receipt nor time at home. CONCLUSIONS: Following hepatopancreatobiliary cancer surgery, there is a high rate of long-term healthcare dependency for OA. There is an immediate high need for homecare that reaches a new baseline after 6 months, and the majority of OA will have at least 1 year with low time at home, most commonly the first year. These findings can aid in preoperative preparation and transitional care planning.


Asunto(s)
Procedimientos Quirúrgicos del Sistema Biliar , Servicios de Atención de Salud a Domicilio , Neoplasias , Humanos , Femenino , Anciano , Casas de Salud , Pancreatectomía
7.
J Natl Compr Canc Netw ; 20(11): 1223-1232.e8, 2022 11.
Artículo en Inglés | MEDLINE | ID: mdl-36351336

RESUMEN

BACKGROUND: Although frailty is known to impact short-term postoperative outcomes, its long-term impact is unknown. This study examined the association between frailty and remaining alive and at home after cancer surgery among older adults. METHODS: Adults aged ≥70 years undergoing cancer resection were included in this population-based retrospective cohort study using linked administrative datasets in Ontario, Canada. The probability of remaining alive and at home in the 5 years after cancer resection was evaluated using Kaplan-Meier methods. Extended Cox regression with time-varying effects examined the association between frailty and remaining alive and at home. RESULTS: Of 82,037 patients, 6,443 (7.9%) had preoperative frailty. With median follow-up of 47 months (interquartile range, 23-81 months), patients with frailty had a significantly lower probability of remaining alive and at home 5 years after cancer surgery compared with those without frailty (39.1% [95% CI, 37.8%-40.4%] vs 62.5% [95% CI, 62.1%-63.9%]). After adjusting for age, sex, rural living, material deprivation, immigration status, cancer type, surgical procedure intensity, year of surgery, and receipt of perioperative therapy, frailty remained associated with increased hazards of not remaining alive and at home. This increase was highest 31 to 90 days after surgery (hazard ratio [HR], 2.00 [95% CI, 1.78-2.24]) and remained significantly elevated beyond 1 year after surgery (HR, 1.56 [95% CI, 1.48-1.64]). This pattern was observed across cancer sites, including those requiring low-intensity surgery (breast and melanoma). CONCLUSIONS: Preoperative frailty was independently associated with a decreased probability of remaining alive and at home after cancer surgery among older adults. This relationship persisted over time for all cancer types beyond short-term mortality and the initial postoperative period. Frailty assessment may be useful for all candidates for cancer surgery, and these data can be used when counseling, selecting, and preparing patients for surgery.


Asunto(s)
Fragilidad , Neoplasias , Anciano , Humanos , Fragilidad/epidemiología , Fragilidad/etiología , Anciano Frágil , Evaluación Geriátrica , Estudios Retrospectivos , Factores de Riesgo , Neoplasias/epidemiología , Neoplasias/cirugía , Ontario/epidemiología
8.
Ann Surg Oncol ; 28(3): 1298-1310, 2021 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-32789531

RESUMEN

BACKGROUND: Functional outcomes are central to decision-making by older adults (OA), but long-term risks after cancer surgery have not been described beyond 1 year for this population. This study aimed to evaluate long-term health care support needs by examining homecare use after cancer surgery for OA. METHODS: This population-based study investigated adults 70 years of age or older with a new cancer diagnosis between 2007 and 2017 who underwent resection. The outcomes were receipt and intensity of homecare from postoperative discharge to 5 years after surgery. Time-to-event analysis with competing events was used. RESULTS: Among 82,037 patients, homecare use was highest (43.7% of eligible patients) in postoperative month 1. The need for homecare subsequently decreased to stabilize between year 1 (13.9%) and year 5 (12.6%). Of the patients not receiving preoperative homecare, 10.9% became long-term users at year 5 after surgery. Advancing age, female sex, frailty, high-intensity surgery, more recent period of surgery, and receipt of preoperative homecare were associated with increased hazards of postoperative homecare. Intensity of homecare went from 10.3 to 10.1 days per patient-month between month 1 and year 1, reaching 12 days per patient-month at year 5. The type of homecare services changed from predominantly nursing care in year 1 (51.9%) to increasing personal support services from year 2 (69.6%) to year 5 (77.5%). CONCLUSION: Receipt of homecare increased long-term after cancer surgery for OA, peaking in the first 6 months and plateauing thereafter at a new baseline. One tenth of the patients without preoperative homecare became long-term homecare users postoperatively, indicating changing health care needs focused on personal support services from year 2 to year 5.


Asunto(s)
Servicios de Atención de Salud a Domicilio , Neoplasias , Factores de Edad , Anciano , Atención a la Salud , Femenino , Humanos , Masculino , Evaluación de Necesidades , Neoplasias/cirugía , Cuidados Paliativos , Alta del Paciente , Cuidados Posoperatorios
9.
Ann Surg Oncol ; 28(12): 7014-7024, 2021 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-34427823

RESUMEN

BACKGROUND: High-intensity cancer surgery is increasingly common among older adults. However, these patients are at high-risk for unexpected intensive care unit (ICU) admissions after surgery. How these admissions impact older adults' long-term outcomes is unknown. METHODS: We performed a population-based, cohort study of older adults (age ≥ 70 years) who underwent high-intensity cancer surgery from 2007 to 2017. Analyses were performed to examine time alive and at home following surgery, defined as time from surgery to nursing home admission or death. Patients were followed for up to 5 years. Extended Cox proportional hazards models examined the independent association between unexpected ICU admission (ICU admissions excluding routine postoperative monitoring) and remaining alive and at home. Subgroup analysis stratified patients by duration of mechanical ventilation (MV). RESULTS: Of 47,367 identified older adults, 7372 (15.6%) had an unexpected ICU admission. Patients with an unexpected ICU admission had a significantly lower probability of being alive and at home at 5 years (26.2%; 95% confidence interval [CI] 25.1-27.2%) compared with those without an unexpected admission (56.8%; 95% CI 56.3-57.4%). After adjusting for baseline characteristics, unexpected ICU admission remained associated with less time alive and at home. The elevated risk of death or nursing home admission persisted for 5 years after surgery (years 2-5: hazard ratio [HR] 1.58, 95% CI 1.50-1.66). Duration of MV was inversely associated with time alive and at home. CONCLUSIONS: Older adults with an unexpected ICU admission after high-intensity cancer surgery are at increased risk for death or admission to a nursing home for at least 5 years.


Asunto(s)
Hospitalización , Neoplasias , Anciano , Estudios de Cohortes , Humanos , Unidades de Cuidados Intensivos , Neoplasias/cirugía , Modelos de Riesgos Proporcionales
10.
Br J Surg ; 109(1): 30-36, 2021 12 17.
Artículo en Inglés | MEDLINE | ID: mdl-34921604

RESUMEN

BACKGROUND: Despite persistently poor oncological outcomes, approaches to the management of T4 colonic cancer remain variable, with the role of neoadjuvant therapy unclear. The aim of this review was to compare oncological outcomes between direct-to-surgery and neoadjuvant therapy approaches to T4 colon cancer. METHODS: A librarian-led systematic search of MEDLINE, Embase, the Cochrane Library, Web of Science, and CINAHL up to 11 February 2020 was performed. Inclusion criteria were primary research articles comparing oncological outcomes between neoadjuvant therapies or direct to surgery for primary T4 colonic cancer. Based on PRISMA guidelines, screening and data abstraction were undertaken in duplicate. Quality assessment was carried out using Cochrane risk-of-bias tools. Random-effects models were used to pool effect estimates. This study compared pathological resection margins, postoperative morbidity, and oncological outcomes of cancer recurrence and overall survival. RESULTS: Four studies with a total of 43 063 patients met the inclusion criteria. Compared with direct to surgery, neoadjuvant therapy was associated with increased rates of margin-negative resection (odds ratio (OR) 2.60, 95 per cent c.i. 1.12 to 6.02; n = 15 487) and 5-year overall survival (pooled hazard ratio 1.42, 1.10 to 1.82, I2 = 0 per cent; n = 15 338). No difference was observed in rates of cancer recurrence (OR 0.42, 0.15 to 1.22; n = 131), 30-day minor (OR 1.12, 0.68 to 1.84; n = 15 488) or major (OR 0.62, 0.27 to 1.44; n = 15 488) morbidity, or rates of treatment-related adverse effects. CONCLUSION: Compared with direct to surgery, neoadjuvant therapy improves margin-negative resection rates and overall survival.


Asunto(s)
Neoplasias del Colon/cirugía , Terapia Neoadyuvante , Neoplasias del Colon/mortalidad , Neoplasias del Colon/terapia , Terapia Combinada , Humanos , Terapia Neoadyuvante/métodos , Resultado del Tratamiento
11.
Eur J Epidemiol ; 36(11): 1097-1101, 2021 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-34279730

RESUMEN

Non-inferiority trials are used to test if a novel intervention is not worse than a standard treatment by more than a prespecified amount, the non-inferiority margin (ΔNI). The ΔNI indicates the amount of efficacy loss in the primary outcome that is acceptable in exchange for non-efficacy benefits in other outcomes. However, non-inferiority designs are sometimes used when non-efficacy benefits are absent. Without non-efficacy benefits, loss in efficacy cannot be easily justified. Further, non-efficacy benefits are scarcely defined or considered by trialists when determining the magnitude of and providing justification for the non-inferiority margin. This is problematic as the importance of a treatment's non-efficacy benefits are critical to understanding the results of a non-inferiority study. Here we propose the routine reporting in non-inferiority trial protocols and publications of non-efficacy benefits of the novel intervention along with the reporting of non-inferiority margins and their justification. The justification should include the specific trade-off between the accepted loss in efficacy (ΔNI) and the non-efficacy benefits of the novel treatment and should describe whether patients and other relevant stakeholders were involved in the definition of the ΔNI.

12.
Surg Endosc ; 34(10): 4593-4600, 2020 10.
Artículo en Inglés | MEDLINE | ID: mdl-31641914

RESUMEN

BACKGROUND: In the treatment of distal sigmoid and rectal cancer, the appropriate level for the ligation of the inferior mesenteric artery (IMA) remains unresolved. High ligation divides the IMA proximally at its origin, and low ligation ligates the IMA distal to the origin of left colic artery. We assessed the association of level of ligation in scheduled minimally invasive resection of sigmoid and rectal cancers on anastomotic leak, postoperative complications, and death within 30 days. METHODS: We identified all patients with primary sigmoid and rectal cancer treated with scheduled minimally invasive resection and primary anastomosis between January 2002 and June 2018 using linked institutional and National Surgical Quality Improvement Program databases. We assessed the association of level of ligation with each outcome by fitting individual univariable and multivariable logistic regression models, adjusting for surgical approach, tumor location, neoadjuvant chemoradiotherapy, and Charlson comorbidity index. RESULTS: We included 158 patients treated with high ligation and 123 patients treated with low ligation. Overall, 12 patients had an anastomotic leak requiring intervention within 30 days: 5 in the high ligation group (3.2%, 95% CI 1.4-7.2%) and 7 in the low ligation group (5.7%, 95% CI 2.8-11.3%). There was no association between the level of ligation and anastomotic leak (unadjusted OR 1.85, 95% CI 0.58-6.38; adjusted OR 0.63, 95% CI 0.16-2.55). Similarly, there was no association between the level of ligation and reoperation for anastomotic leak (OR 1.29, 95% CI 0.15-10.9), major complications (Clavien-Dindo III-V; OR 2.22, 95% CI 0.90-5.77), minor complications (Clavien-Dindo I-II; OR 1.51, 95% CI 0.88-2.60), and all complications (OR 1.58, 95% CI 0.94-2.67). No deaths occurred in either group. CONCLUSIONS: There was no association of level of ligation of the IMA with anastomotic leak, postoperative complications as a composite, or death. The choice of high or low ligation of the IMA should be made based on technical factors such as length for the creation of a tension-free anastomosis.


Asunto(s)
Fuga Anastomótica/etiología , Colon Sigmoide/cirugía , Arteria Mesentérica Inferior/cirugía , Procedimientos Quirúrgicos Mínimamente Invasivos , Complicaciones Posoperatorias/etiología , Complicaciones Posoperatorias/mortalidad , Neoplasias del Recto/cirugía , Anciano , Anastomosis Quirúrgica/efectos adversos , Estudios de Cohortes , Femenino , Humanos , Ligadura , Masculino , Persona de Mediana Edad , Procedimientos Quirúrgicos Mínimamente Invasivos/efectos adversos , Terapia Neoadyuvante/efectos adversos , Resultado del Tratamiento
13.
Ann Surg ; 269(5): 849-855, 2019 05.
Artículo en Inglés | MEDLINE | ID: mdl-30339624

RESUMEN

OBJECTIVE: To determine whether laparoscopic surgery is noninferior to open surgery for rectal cancer in terms of quality of surgical resection outcomes. BACKGROUND: Randomized clinical trials (RCTs) have evaluated the oncologic safety of laparoscopic versus open surgery for rectal cancer with conflicting results. Prior meta-analyses comparing these operative approaches in terms of quality of surgical resection aimed to demonstrate if one approach was superior. However, this method is not appropriate and potentially misleading when noninferiority RCTs are included. METHODS: MEDLINE, EMBASE, and Cochrane were searched to identify RCTs comparing these operative approaches. Risk differences (RDs) were pooled using random-effects meta-analyses. One-sided Z tests were used to determine noninferiority. Noninferiority margins (ΔNI) for circumferential resection margin (CRM), plane of mesorectal excision (PME), distal resection margin (DRM), and a composite outcome ("successful resection") were based on the consensus of 58 worldwide experts. RESULTS: Fourteen RCTs were included. Laparoscopic resection was noninferior compared with open resection for the rate of positive CRM [RD 0.79%, 90% confidence interval (CI) -0.46 to 2.04, ΔNI = 2.33%, PNI = 0.026], incomplete PME (RD 1.16%, 90% CI -0.27 to 2.59, ΔNI = 2.85%, PNI = 0.025), and positive DRM (RD 0.15%, 90% CI -0.58 to 0.87, ΔNI = 1.28%, PNI = 0.005). For the rate of "successful resection" (RD 6.16%, 90% CI 2.30-10.02), the comparison was inconclusive when using the ΔNI generated by experts (ΔNI = 2.71%, PNI = 0.07), although no consensus was achieved for this ΔNI. CONCLUSIONS: Laparoscopy was noninferior to open surgery for rectal cancer in terms of individual quality of surgical resection outcomes. These findings are concordant with RCTs demonstrating noninferiority for long-term oncologic outcomes between the 2 approaches.


Asunto(s)
Laparoscopía , Neoplasias del Recto/cirugía , Procedimientos Quirúrgicos del Sistema Digestivo/métodos , Procedimientos Quirúrgicos del Sistema Digestivo/normas , Humanos , Calidad de la Atención de Salud , Resultado del Tratamiento
14.
Can J Surg ; 62(6): 426-435, 2019 12 01.
Artículo en Inglés | MEDLINE | ID: mdl-31782298

RESUMEN

Background: The use of prophylactic mesh in end colostomy procedures has been shown to reduce the rate of parastomal hernia. However, the degree to which the practice has been adopted clinically remains unknown. We conducted a study to evaluate the current opinions and practice patterns of Canadian and US colorectal surgeons with regard to the use of prophylactic mesh in end colostomy. Methods: Between May and July 2017, we conducted an internet-based survey of colorectal surgeons in Canada and the United States (selected at random). Using a questionnaire designed and tested for this study, we assessed the rate of mesh use, types of mesh and placement techniques, and perceived barriers and facilitators associated with the practice. Results: Forty-eight (51.6%) of 93 invited Canadian surgeons and 253 (16.6%) of 1521 invited US surgeons responded (overall response rate 18.6%). Of the 301 respondents, 32 (10.6%) were currently using mesh, 32 (10.6%) had previously used mesh, and 237 (78.7%) had never used mesh. Of 29 respondents currently using mesh, 12 (41.4%) used it only in selected patients; the majority used a sublay technique (20 [69.0%]) and biologic mesh (17 [58.6%]). Most respondents agreed that parastomal hernias are common and negatively affect quality of life; however, there remained concerns about evidence quality and the perceived risk associated with mesh among those who had never or had previously used mesh. Conclusion: Prophylactic mesh placement remains relatively uncommon; when used, biologic mesh was the most common type. Many surgeons were not convinced of the safety or efficacy of prophylactic mesh placement.


Contexte: Il a été démontré que la pose d'un treillis prophylactique durant une colostomie terminale réduit le risque de hernie parastomale. On ignore toutefois à quel point cette pratique a été adoptée en contexte clinique. Nous avons mené une étude pour connaître l'opinion et les habitudes des chirurgiens colorectaux canadiens et américains quant à cette intervention. Méthodes: De mai à juillet 2017, nous avons mené un sondage en ligne auprès de chirurgiens colorectaux canadiens et américains sélectionnés aléatoirement. À l'aide d'un questionnaire conçu et validé pour cette étude, nous avons évalué le taux de pose de treillis, le type de treillis et la technique utilisé, ainsi que les facteurs facilitant ou limitant l'intervention. Résultats: Au total, 48 des 93 chirurgiens canadiens (51,6 %) et 253 des 1521 chirurgiens américains (16,6 %) approchés ont répondu au sondage (taux de réponse global : 18,6 %). Sur les 301 répondants, 32 (10,6 %) ont dit qu'ils installent actuellement des treillis, 32 (10,6 %) ont dit en avoir installé, et 237 (78,7 %) ont dit n'en avoir jamais installé. Parmi 29 répondants posant actuellement des treillis, 12 (41,4 %) ont déclaré y avoir recours pour certains patients seulement; la majorité pose les treillis dans l'espace prépéritonéal (20 [69,0 %]) et se sert de treillis biologiques (17 [58,6 %]). La plupart des répondants s'entendaient pour dire que les hernies parastomales sont courantes et ont des répercussions négatives sur la qualité de vie des patients; cependant, les chirurgiens n'ayant jamais installé de treillis ou en ayant seulement installé par le passé se sont dits préoccupés par la qualité des données et les risques perçus associés aux treillis. Conclusion: La pose d'un treillis à des fins prophylactiques demeure relativement rare. Les treillis biologiques étaient les plus fréquemment utilisés par les répondants. Bon nombre des chirurgiens questionnés n'étaient pas convaincus de l'innocuité ou de l'efficacité de l'intervention.


Asunto(s)
Colostomía/efectos adversos , Hernia Ventral/prevención & control , Hernia Incisional/prevención & control , Complicaciones Posoperatorias/prevención & control , Pautas de la Práctica en Medicina , Mallas Quirúrgicas , Actitud del Personal de Salud , Canadá , Colostomía/instrumentación , Hernia Ventral/etiología , Humanos , Hernia Incisional/etiología , Selección de Paciente , Complicaciones Posoperatorias/etiología , Estados Unidos
15.
Ann Surg ; 268(1): 77-85, 2018 07.
Artículo en Inglés | MEDLINE | ID: mdl-28654541

RESUMEN

OBJECTIVE: To gain contemporary insights from residents and surgeons regarding the care of older surgical patients. BACKGROUND DATA: With worldwide aging, efforts over the past decade have attempted to increase surgeons' abilities to care for older adults, but a current understanding of attitudes, knowledge, practices, and needs is missing. METHODS: Between July 2016 and September 2016 we conducted a national Web-based survey sampling all general surgery residents and academic general surgeons using a questionnaire designed and tested for this purpose. Summative scales within each domain (attitudes, knowledge, practices, and needs) were created and compared between groups. Open-ended responses were analyzed with thematic analysis. RESULTS: Ninety-four of 172 invited residents (55%) and 80 of 243 invited surgeons (33%) across 14 general surgery programs responded with no missing data. Both groups had favorable attitudes (83% vs 68%, P = 0.02). However, 80% of residents and 76% of surgeons had medium-level knowledge test scores, and few had prior training. Most respondents reported only sometimes performing guideline-recommended practices (71% vs 73%, P = 0.55). Gaps in training and care delivery were identified. Residents wanted focused, high-yield materials and case-oriented practical skills training. Respondents reported further improvements may come from building surgeons' capacity, enhancing collaboration including perioperative geriatric services, better preoperative assessment, increased adherence to perioperative guidelines, and greater community-based supports to recovery. CONCLUSIONS: Residents and surgeons have favorable attitudes, but only moderate geriatric-specific knowledge and only some guideline-adherent practices. We identified gaps in training and care delivery with targets for future knowledge translation and quality improvement initiatives.


Asunto(s)
Actitud del Personal de Salud , Competencia Clínica/estadística & datos numéricos , Cirugía General , Servicios de Salud para Ancianos , Pautas de la Práctica en Medicina/estadística & datos numéricos , Anciano , Anciano de 80 o más Años , Canadá , Estudios Transversales , Cirugía General/educación , Cirugía General/normas , Cirugía General/estadística & datos numéricos , Adhesión a Directriz , Servicios de Salud para Ancianos/normas , Humanos , Internado y Residencia , Evaluación de Necesidades , Guías de Práctica Clínica como Asunto , Investigación Cualitativa , Cirujanos/educación , Cirujanos/normas , Cirujanos/estadística & datos numéricos , Encuestas y Cuestionarios
16.
Ann Surg ; 267(6): 1056-1062, 2018 06.
Artículo en Inglés | MEDLINE | ID: mdl-29215370

RESUMEN

BACKGROUND: Over the past 2 decades, there has been an increase in opioid use and subsequently, opioid deaths. The amount of opioid prescribed to surgical patients has also increased. The aim of this systematic review was to determine postdischarge opioid consumption in surgical patients compared with the amount of opioid prescribed. Secondary outcomes included adequacy of pain control and disposal methods for unused opioids. OBJECTIVE: The objective of this study is to characterize postdischarge opioid consumption and prescription patterns in surgical patients. METHODS: A systematic search in MEDLINE and EMBASE identified 11 patient survey studies reporting on postdischarge opioid use in 3525 surgical patients. RESULTS: The studies reported on a variety of surgical operations, including abdominal surgery, orthopedic procedures, tooth extraction, and dermatologic procedures. The majority of patients consumed 15 pills or less postdischarge. The proportion of used opioids ranged from 5.6% to 59.1%, with an outlier of 90.1% in pediatric spinal fusion patients. Measured pain scores of those taking opioids ranged between 2 and 5 out of 10 and the majority of patients were satisfied with their pain control. Seventy percent of patients kept the excess opioids. Where planned disposal methods were reported, between 4% and 59% of patients planned proper disposal. CONCLUSION: This study suggests that surgical patients are using substantially less opioid than prescribed. There is a lack of awareness regarding proper disposal of leftover medication, leaving excess opioid that may be used inappropriately by the patient or others. Education for providers and clinical practice guidelines that provide guidance on prescription of outpatient of opioids are required.


Asunto(s)
Analgésicos Opioides/uso terapéutico , Prescripciones de Medicamentos/estadística & datos numéricos , Dolor Postoperatorio/tratamiento farmacológico , Alta del Paciente , Pautas de la Práctica en Medicina , Almacenaje de Medicamentos/métodos , Humanos , Manejo del Dolor
17.
Ann Surg Oncol ; 25(11): 3171-3178, 2018 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-30051366

RESUMEN

INTRODUCTION: Quality of surgical resection metrics (QSRMs) have been used as surrogates for long-term oncologic outcomes in non-inferiority randomized clinical trials (RCTs) comparing laparoscopic and open surgery for rectal cancer. However, non-inferiority margins (ΔNI) for QSRMs have not been previously defined. METHODS: A two-round, web-based Delphi was used to define ΔNI for four QSRMs: positive circumferential resection margin (CRM), incomplete plane of mesorectal excision (PME), positive distal resection margin (DRM), and a composite of these outcomes. Overall, 130 international experts in rectal cancer (68 surgeons, 20 medical oncologists, 16 radiation oncologists, and 26 pathologists) were invited to participate. Experts were presented with evidence syntheses summarizing the association between QSRMs and long-term outcomes, and pooled quality of surgical resection outcomes for open surgery, and were asked to provide ΔNI for all outcomes balancing the risks and benefits of minimally invasive surgery. RESULTS: Seventy-two experts participated: 57 completed the initial questionnaire and 58 completed the revised questionnaire, with 43 participating in both rounds. Consensus was reached for all individual QSRM ΔNI but not for the composite. The mean (standard deviation) ΔNI was an absolute difference of 2.33% (1.59%) for the proportion of positive CRMs when comparing surgical interventions for the treatment of rectal cancer: 2.85% (1.83%) for incomplete PME; 1.28% (1.13%) for positive DRMs; and 2.71% (2.28%) for the composite. However, opinions varied widely for the composite outcome. CONCLUSIONS: Web-based Delphi processes are a feasible approach to generate ΔNI to evaluate novel surgical interventions. The generated ΔNI for QSRMs for rectal cancer can be used for future RCTs and non-inferiority meta-analyses.


Asunto(s)
Procedimientos Quirúrgicos del Sistema Digestivo/métodos , Laparoscopía , Complicaciones Posoperatorias , Mejoramiento de la Calidad , Neoplasias del Recto/patología , Neoplasias del Recto/cirugía , Consenso , Estudios de Equivalencia como Asunto , Estudios de Seguimiento , Humanos , Márgenes de Escisión , Indicadores de Calidad de la Atención de Salud , Resultado del Tratamiento
18.
Dis Colon Rectum ; 61(12): 1442-1453, 2018 12.
Artículo en Inglés | MEDLINE | ID: mdl-30371549

RESUMEN

BACKGROUND: The traditional approach for perforated diverticulitis, the Hartmann procedure, has considerable morbidity and the challenge of stoma reversal. Alternative procedures, including primary resection and anastomosis and laparoscopic lavage, have been proposed but remain controversial. OBJECTIVE: The purpose of this study was to compare operative strategies for perforated diverticulitis. DATA SOURCES: MEDLINE, Embase, Cochrane Library, and the grey literature were searched from inception to October 2017. STUDY SELECTION: We included randomized clinical trials evaluating operative strategies for perforated diverticulitis. INTERVENTIONS: Hartmann procedure, primary resection and anastomosis, and laparoscopic lavage were included. MAIN OUTCOME MEASURES: Data were independently extracted by 2 investigators. Risk of bias was evaluated using the Cochrane risk-of-bias tool. Pooled risk ratios for major complications, reoperation, and mortality were determined using random-effects models. RESULTS: Six trials including 626 patients with perforated diverticulitis were identified. Laparoscopic lavage and sigmoidectomy had comparable rates of early reoperation and postoperative mortality; major complications (Clavien-Dindo >IIIa) were more frequent after laparoscopic lavage (RR = 1.68 (95% CI, 1.10-2.56); 3 trials, 305 patients). Comparing approaches for sigmoidectomy, primary resection and anastomosis had similar rates of major complications (RR = 0.88 (95% CI, 0.49-1.55); 3 trials, 255 patients) and postoperative mortality (RR = 0.58 (95% CI, 0.20-1.70); 3 trials, 254 patients) compared with the Hartmann procedure. However, patients who underwent primary resection and anastomosis were more likely to be stoma free at 12 months compared with the Hartmann procedure (RR = 1.40 (95% CI, 1.18-1.67); 4 trials, 283 patients) and to experience fewer major complications related to the stoma reversal procedure (RR = 0.26 (95% CI, 0.07-0.89); 4 trials, 186 patients). LIMITATIONS: There were no limitations to this study. CONCLUSIONS: Laparoscopic lavage is associated with increased risk of major complications versus primary resection for Hinchey III diverticulitis. The lower rate of stoma reversal and higher rate of complications after the Hartmann procedure suggest primary resection and anastomosis as the optimal management of perforated diverticulitis.


Asunto(s)
Colon Sigmoide/cirugía , Diverticulitis del Colon/cirugía , Perforación Intestinal/cirugía , Complicaciones Posoperatorias/etiología , Anastomosis Quirúrgica , Procedimientos Quirúrgicos del Sistema Digestivo/efectos adversos , Procedimientos Quirúrgicos del Sistema Digestivo/métodos , Diverticulitis del Colon/complicaciones , Humanos , Perforación Intestinal/etiología , Laparoscopía/efectos adversos , Irrigación Terapéutica/efectos adversos
19.
Can J Surg ; 61(2): 114-120, 2018 04.
Artículo en Inglés | MEDLINE | ID: mdl-29582747

RESUMEN

BACKGROUND: Patients with poor underlying prognosis experiencing surgical emergencies face challenging treatment decisions. The Best Case/Worst Case (BC/WC) framework has improved shared decision-making by surgeons, but it is unclear whether residents can be similarly trained. We evaluated senior general surgical residents' acceptance of the BC/WC tool and their attitudes, confidence and actions before and after training. METHODS: Two-hour training included a didactic session, live demonstration, small-group practice and debriefing. We developed questionnaires to evaluate residents' attitudes, confidence and actions at 3 time points: before the intervention, after the intervention and 6 months after the intervention. We used the Ottawa Decision Support Framework Acceptability questionnaire to evaluate acceptability and a structured observation form to evaluate performance. RESULTS: Eighteen (50%) of 36 invited residents participated. Most residents (83%) felt that a new communication tool would be useful. Almost all (94%) used BC/WC in practice. Residents found the tool acceptable and useful to enhance preference-sensitive communications. They felt that the training was valuable and that role play was its greatest strength but that these situations were challenging to simulate. Barriers to BC/WC use included time constraints and difficulty defining the best and worst cases precisely. Summative attitudes and confidence scores were not different before and after the intervention; however, actions scores were higher after the intervention (p = 0.04). Residents performed a median of 15 (interquartile range 13-17) of the 19 elements on the formative performance evaluation. Commonly missed items were narrating outcomes of palliative approaches, prompting deliberation and providing treatment recommendations. CONCLUSION: Senior residents found the BC/WC tool to be acceptable and useful, and are amenable to training in this type of communication. After training, self-reported actions scores increased, and observed performance was accurate.


CONTEXTE: La prise de décisions relatives au traitement est difficile pour les patients qui ont un pronostic sous-jacent défavorable et qui envisagent une intervention chirurgicale d'urgence. Le cadre d'évaluation de la meilleure et de la pire issue possible (Best Case/Worst Case framework [BC/WC]) a amélioré la prise de décision partagée chez les chirurgiens, mais on ignore si les médecins résidents adopteraient aussi facilement une formation sur un tel cadre. Nous avons évalué à quel point les médecins résidents principaux en chirurgie générale étaient prêts à accepter le cadre BC/WC, ainsi que leur attitude, leur confiance et leurs actions avant et après une formation sur celui-ci. MÉTHODES: La formation de 2 heures comprenait une présentation didactique, une démonstration pratique, une période d'essai en petits groupes et un débreffage. Nous avons créé un questionnaire évaluant l'attitude, la confiance et les actions des médecins résidents à 3 moments : avant la formation, immédiatement après celle-ci et 6 mois plus tard. Nous avons utilisé le questionnaire sur l'admissibilité du Modèle d'aide à la décision d'Ottawa pour évaluer le degré d'acceptation du cadre, et un formulaire d'observation structurée pour évaluer son application au travail. RÉSULTATS: Des 36 médecins résidents invités, 18 (50 %) ont accepté de participer. La plupart d'entre eux (83 %) croyaient qu'un nouvel outil de communication leur serait utile. Presque tous (94 %) ont appliqué le cadre BC/WC dans leur travail. Ils l'ont trouvé acceptable, et considéraient qu'il permettait d'améliorer la communication tenant compte des préférences. Selon eux, la formation était utile, particulièrement les mises en situation, mais la nature des interactions se prêtait mal à la simulation. Interrogés sur les obstacles à l'application du cadre, ils ont cité les contraintes de temps et la difficulté de définir avec précision la meilleure et la pire issue. Les résultats sommatifs pour l'attitude et la confiance étaient similaires avant et après la formation; cependant, la note pour les actions était plus élevée après la formation qu'avant (p = 0,04). Pour l'évaluation formative du travail, la note médiane était de 15 (écart interquartile : 13 à 17), sur un total de 19 éléments. Parmi les éléments couramment oubliés, notons la description des issues des approches palliatives, l'incitation à la discussion et la formulation de recommandations de traitement. CONCLUSION: Les médecins résidents considèrent le cadre BC/WC acceptable et utile, et seraient disposés à suivre une formation sur le type de communication qu'il prône. Après la formation, la note de l'auto-évaluation des actions a augmenté, une tendance aussi constatée à l'observation du travail.


Asunto(s)
Competencia Clínica , Toma de Decisiones , Conocimientos, Actitudes y Práctica en Salud , Internado y Residencia/métodos , Relaciones Médico-Paciente , Índice de Severidad de la Enfermedad , Cirujanos/educación , Adulto , Urgencias Médicas , Humanos , Cirujanos/psicología
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