Light and shadow of watch-and-wait strategy in rectal cancer: oncological result, clinical outcomes, and cost-effectiveness analysis.

BACKGROUND: The watch-and-wait (WW) strategy is a potential option for patients with rectal cancer who obtain a complete clinic response after neoadjuvant therapy. The aim of this study is to analyze the long-term oncological outcomes and perform a cost-effectiveness analysis in patients undergoing this strategy for rectal cancer. MATERIAL AND METHODS: The data of patients treated with the WW strategy were prospectively collected from January 2015 to January 2020. A control group was created, matched 1:1 from a pool of 480 patients undergoing total mesorectal excision. An independent company carried out the financial analysis. Clinical and oncological outcomes were analyzed in both groups. Outcome parameters included surgical and follow-up costs, quality-adjusted life years (QALYs), and the incremental cost per QALY gained or the incremental cost-effectiveness ratio (ICER). RESULTS: Forty patients were included in the WW group, with 40 patients in the surgical group. During a median follow-up period of 36 months, metastasis-free survival (MFS) and overall survival (OS) were similar in the two groups. In the WW group, nine (22%) local regrowths were detected in the first 2 years. The permanent stoma rate was slightly higher after salvage surgery in the WW group compared to the surgical group (48.5% vs 20%, p < 0.01). The cost-effectiveness analysis was slightly better for the WW group, especially for low rectal cancer compared to medium-high rectal cancer (ICER = - 108,642.1 vs ICER = - 42,423). CONCLUSIONS: The WW strategy in locally advanced rectal cancer offers similar oncological outcomes with respect to the surgical group and excellent results in quality of life and cost outcomes, especially for low rectal cancer. Nonetheless, the complex surgical field during salvage surgery can lead to a high permanent stoma rate; therefore, the careful selection of patients is mandatory.

Impact of Cancer Care Regionalization on Patient Volume.

BACKGROUND: Cancer centers are regionalizing care to expand patient access, but the effects on patient volume are unknown. This study aimed to compare patient volumes before and after the establishment of head and neck regional care centers (HNRCCs). METHODS: This study analyzed 35,394 unique new patient visits at MD Anderson Cancer Center (MDACC) before and after the creation of HNRCCs. Univariate regression estimated the rate of increase in new patient appointments. Geospatial analysis evaluated patient origin and distribution. RESULTS: The mean new patients per year in 2006-2011 versus 2012-2017 was 2735 ± 156 patients versus 3155 ± 207 patients, including 464 ± 78 patients at HNRCCs, reflecting a 38.4 % increase in overall patient volumes. The rate of increase in new patient appointments did not differ significantly before and after HNRCCs (121.9 vs 95.8 patients/year; P = 0.519). The patients from counties near HNRCCs, showed a 210.8 % increase in appointments overall, 33.8 % of which were at an HNRCC. At the main campus exclusively, the shift in regional patients to HNRCCs coincided with a lower rate of increase in patients from the MDACC service area (33.7 vs. 11.0 patients/year; P = 0.035), but the trend was toward a greater increase in out-of-state patients (25.7 vs. 40.3 patients/year; P = 0.299). CONCLUSIONS: The creation of HNRCCs coincided with stable increases in new patient volume, and a sizeable minority of patients sought care at regional centers. Regional patients shifted to the HNRCCs, and out-of-state patient volume increased at the main campus, optimizing access for both local and out-of-state patients.

Case-matched analysis of robotic versus open surgical enucleation for pancreatic tumours: A comparative cost-effectiveness study.

BACKGROUND: Enucleation has widely spread as an alternative strategy in the treatment of small pancreatic tumours and cystic lesions. To date there are limited data on perioperative outcomes after pancreatic enucleation performed using a minimally invasive robotic technique, particularly regarding the risk factors associated with postoperative pancreatic fistula (POPF). We perform a comparative study of robotic pancreatic enucleation (RPE) and open enucleation (OPE) with the aim of evaluating clinical and cost-effective outcomes. METHODS: This is a case-matched analysis of patients who underwent robotic and open pancreatic enucleation performed at Sanchinarro University Hospital, Madrid, from October 2014 to December 2021. Patient data were obtained retrospectively. Clinicopathologic characteristics and perioperative and postoperative outcomes were recorded and analysed. Two groups of demographically similar patients were analysed: the robotic group (n = 20) and the open group (n = 20). The patient characteristics of the two groups have been compared. From February 2015, quality-adjusted life years (QALYs) are also included and prospectively recorded in the database and used to measure the effectiveness of the treatment. RESULT: A total of 20 RPE and 20 OPE have been included. The incremental cost of the robotic approach versus open was €2617.85(CI 95% 1601.48; 3634.24) and the incremental utility was 0.0879 QALYs (CI 95% 0.0834; 0.0925). The estimated ICER for patients was €29,782.13 (CI 95% 17,313.29; 43,576.01) per QALY gained. Robotic resection resulted a shorter postoperative hospital stay, less wound infections, faster recovery diet and a similar operating time. The two groups had similar complication rates. Pathological data were similar for both procedures. CONCLUSION: RPE resulted in a shorter hospital stay and less blood loss and morbidity, comparable with the outcomes of open enucleation. RPE may also be acceptable in terms of cost-effectiveness.

External quality assessment providers' services appear to more impact the immunohaematology performance of laboratories than national regulatory and economic conditions.

OBJECTIVES: Medical laboratories may, at their own discretion, exceed but not undercut regulatory quality requirements. Available economic resources, however, may drive or hinder eagerness to exceed minimum requirements. Depending on the respective scopes of regulatory and economic framework conditions, differing levels of quality efforts to safeguard laboratory performance can be anticipated. However, this has not yet been investigated. METHODS: Immunohaematology external quality assessment (EQA) results collected by 26 EQA providers from their participant laboratories in 73 countries from 2004 to 2019 were evaluated. Error rates were aggregated in groups according to the respective national regulatory and economic framework conditions, to whether or not expert advice was provided in case of incorrect results, and the frequency of EQA samples. RESULTS: These representative data indicate no association between national regulatory (mandatory participation in EQA, monitoring of performance of individual laboratories by authorities, financial consequences of incorrect results) and economic (level of national income, share of national health expenditure) conditions to the quality performance of medical laboratories in immunohaematology. However, EQA providers' support for laboratories in the event of incorrect results appear to be associated with lower error rates, but a high EQA sample frequency with higher error rates. CONCLUSIONS: Further research into the impact of introducing or changing services of EQA providers is needed to confirm the results found in this first of its kind study.

Robotic-assisted right colectomy versus laparoscopic approach: case-matched study and cost-effectiveness analysis.

AIM: The aim of this study is to compare clinical and oncological outcomes of robot-assisted right colectomy with those of conventional laparoscopy-assisted right colectomy, reporting for the first time in literature, a cost-effectiveness analysis. METHODS: This is a case-matched prospective non-randomized study conducted from October 2013 to October 2017 at Sanchinarro University Hospital, Madrid. Patients with right-sided colonic adenocarcinoma or adenoma, not suitable endoscopic resection were treated with robot-assisted right colectomy and a propensity score-matched (1:1) was used to balance preoperative characteristics of a laparoscopic control group. Perioperative, postoperative, long-term oncological results and costs were analysed, and quality-adjusted life years (QALY), and the cost-effectiveness ratio (ICER) were calculated. The primary end point was to compare the cost-effectiveness differences between both groups. A willingness-to-pay of 20,000 and 30,000 per QALY was used as a threshold to recognize which treatment was most cost effective. RESULTS: Thirty-five robot-assisted right colectomies were included and a group of 35 laparoscopy-assisted right colectomy was selected. Compared with the laparoscopic group, the robotic group was associated with longer operation times (243 min vs. 179 min, p < 0.001). No significant difference was observed in terms of total costs between the robotic and laparoscopic groups (9455.14 vs 8227.50 respectively, p = 0.21). At a willingness-to-pay threshold of 20,000 and 30,000, there was a 78.78-95.04% probability that the robotic group was cost effective relative to laparoscopic group. CONCLUSION: Robot-assisted right colectomy is a safe and feasible technique and is a cost-effective procedure.

A cost-effectiveness analysis of robotic versus laparoscopic distal pancreatectomy.

AIM: There is no study in the literature that evaluates the cost-effectiveness of robotic distal pancreatectomy (RDP) over laparoscopic distal pancreatectomy (LDP). We performed a comparative study of RDP and LDP with the aim of evaluating clinical and cost-effective outcomes. MATERIAL AND METHODS: This is an observational, comparative prospective nonrandomized study. The primary end point was to compare the cost-effectiveness differences between both groups. A willingness to pay of €20 000 and €30 000 per quality-adjusted life year (QALY) was used as a threshold to recognize which treatment was most cost-effective. RESULTS: A total of 31 RDP and 28 LDP have been included. The overall mean total cost was similar in both groups (RDP: €9712.15 versus LDP: €9424.68; P > .5). Mean QALYs for RDP (0.652) was higher than that associated with LDP (0.59) (P > .5). CONCLUSION: This study seems to provide data of cost-effectiveness between RDP and LDP approaches, showing some benefits for RDP.

Assessment of Common Criteria for Awake Extubation in Infants and Young Children.

BACKGROUND: Practice patterns surrounding awake extubation of pediatric surgical patients remain largely undocumented. This study assessed the value of commonly used predictors of fitness for extubation to determine which were most salient in predicting successful extubation following emergence from general anesthesia with a volatile anesthetic in young children. METHODS: This prospective, observational study was performed in 600 children from 0 to 7 yr of age. The presence or absence of nine commonly used extubation criteria in children were recorded at the time of extubation including: facial grimace, eye opening, low end-tidal anesthetic concentration, spontaneous tidal volume greater than 5 ml/kg, conjugate gaze, purposeful movement, movement other than coughing, laryngeal stimulation test, and oxygen saturation. Extubations were graded as Successful, Intervention Required, or Major Intervention Required using a standard set of criteria. The Intervention Required and Major Intervention Required outcomes were combined as a single outcome for analysis of predictors of success. RESULTS: Successful extubation occurred in 92.7% (556 of 600) of cases. Facial grimace odds ratio, 1.93 (95% CI, 1.03 to 3.60; P = 0.039), purposeful movement odds ratio, 2.42 (95% CI, 1.14 to 5.12; P = 0.022), conjugate gaze odds ratio, 2.10 (95% CI, 1.14 to 4.01; P = 0.031), eye opening odds ratio, 4.44 (95% CI, 1.06 to 18.64; P= 0.042), and tidal volume greater than 5 ml/kg odds ratio, 2.66 (95% CI, 1.21 to 5.86; P = 0.015) were univariately associated with the Successful group. A stepwise increase in any one, in any order, of these five predictors being present, from one out of five and up to five out of five yielded an increasing positive predictive value for successful extubation of 88.3% (95% CI, 82.4 to 94.3), 88.4% (95% CI, 83.5 to 93.3), 96.3% (95% CI, 93.4 to 99.2), 97.4% (95% CI, 94.4 to 100), and 100% (95% CI, 90 to 100). CONCLUSIONS: Conjugate gaze, facial grimace, eye opening, purposeful movement, and tidal volume greater than 5 ml/kg were each individually associated with extubation success in pediatric surgical patients after volatile anesthetic. Further, the use of a multifactorial approach using these predictors, may lead to a more rational and robust approach to successful awake extubation.

Chile's National Advisory Committee on Immunization (CAVEI): Evidence-based recommendations for public policy decision-making on vaccines and immunization.

A National Immunization Technical Advisory Group (NITAG) provides independent, evidence-based recommendations to the Ministry of Health for immunization programmes and policy formulation. In this article, we describe the structure, functioning and work processes of Chile's NITAG (CAVEI) and assess its functionality, quality of work processes and outputs, and integration of the committee into the Ministry of Health policy process using the Assessment tool for National Immunization Technical Advisory Groups. Among its strengths, CAVEI's administrative and work plasticity allows it to respond in a timely manner to the Ministry of Health's requests and proactively raise subjects for review. Representation of multiple areas of expertise within the committee makes CAVEI a robust and balanced entity for the development of evidence-based comprehensive recommendations. High ranking profile of the Secretariat structure furthers CAVEI's competences in policymaking and serves as a bridge between the committee and international initiatives in the field of immunizations.

Assessment of Immunogenicity and Neutralisation Efficacy of Viral-Vectored Vaccines Against Chikungunya Virus.

Chikungunya virus (CHIKV) has caused extensive outbreaks in several countries within the Americas, Asia, Oceanic/Pacific Islands, and Europe. In humans, CHIKV infections cause a debilitating disease with acute febrile illness and long-term polyarthralgia. Acute and chronic symptoms impose a major economic burden to health systems and contribute to poverty in affected countries. An efficacious vaccine would be an important step towards decreasing the disease burden caused by CHIKV infection. Despite no licensed vaccine is yet available for CHIKV, there is strong evidence of effective asymptomatic viral clearance due to neutralising antibodies against the viral structural proteins. We have designed viral-vectored vaccines to express the structural proteins of CHIKV, using the replication-deficient chimpanzee adenoviral platform, ChAdOx1. Expression of the CHIKV antigens results in the formation of chikungunya virus-like particles. Our vaccines induce high frequencies of anti-chikungunya specific T-cell responses as well as high titres of anti-CHIKV E2 antibodies with high capacity for in vitro neutralisation. Our results indicate the potential for further clinical development of the ChAdOx1 vaccine platform in CHIKV vaccinology.

Cost-effectiveness of Randomized Study of Laparoscopic Versus Open Bilateral Inguinal Hernia Repair.

OBJECTIVE: The aim of this study is to compare the clinical and cost-effective outcomes of the open Lichtenstein repair (OL) and laparoscopic trans-abdominal preperitoneal (TAPP) repair for bilateral inguinal hernias. SUMMARY BACKGROUND DATA: A cost-effective analysis of laparoscopic versus open inguinal hernia repair is still not well addressed, especially regarding bilateral hernia. METHODS: This is a clinical and cost-effectiveness analysis within a randomized prospective study conducted at Sanchinarro University Hospital.Cases of primary, reducible bilateral inguinal hernia were included and randomized using a simple randomization program.The outcome parameters included surgical and postoperative costs, quality adjusted life years (QALY), and incremental cost per QALY gained or the incremental cost effectiveness ratio. RESULTS: Between March 2013 and January 2017, 165 patients were enrolled in this study (81 of them underwent TAPP and 84 OL).The TAPP procedure had less early postoperative pain (P = 0.037), a shorter length of stay (P = 0.001), and fewer postoperative complications (P = 0.002) when compared with the OL approach. The overall cost of TAPP procedure was higher compared with the OL cost (1,683.93&OV0556; vs 1192.83&OV0556;, P = 0.027). The mean QALYs at 1 year for TAPP (0.8094) was higher than that associated with OL (0.6765) (P = 0.018). At a willingness-to-pay threshold of 20,000 &OV0556; and 30,000 &OV0556;, there was a 95.38% and 97.96% probability that TAPP was more cost-effective relative to OL. CONCLUSIONS: The TAPP procedure for bilateral inguinal hernia appears to be more cost-effective compared with OL.

Robotic versus laparoscopic distal pancreatectomy: A comparative study of clinical outcomes and costs analysis.

BACKGROUND: The robotic surgery cost presents a critical issue which has not been well addressed yet. This study aims to compare the clinical outcomes and cost differences of robotic distal pancreatectomy (RDP) versus laparoscopic distal pancreatectomy (LDP). METHODS: Data were abstracted prospectively from 2011 to 2017. An independent company performed the financial analysis. RESULTS: A total of 28 RDP and 26 LDP were included. The mean operative time was significantly lower in the LDP (294 vs 241 min; p = 0.02). The main intra and post-operative data were similar, except for the conversion rate (RDP: 3.6% vs LDP: 19.2%; p = 0.04) and hospital stay (RDP: 8.9 vs LDP 13.1 days; p = 0.04). The mean total costs were similar in both groups (RDP: 9198.64 € vs LDP: 9399.74 €; p > 0.5). CONCLUSIONS: RDP showed lower conversion rate and shorter hospital stay than LDP at the price of longer operative time. RDP is financially comparable to LDP.

Valoración del uso de inmunoensayos para el diagnóstico rápido de tuberculosis en población abierta / Evaluation of immunoassays use for the fast diagnosis of tuberculosis in open population

Se valoró la utilización de técnicas inmunológicas como métodos alternativos en el diagnóstico de tuberculosis pulmonar(TBP), realizando la búsqueda de antígenos de M. tuberculosis y anticuerpos dirigidos contra la misma bacteria en suero de pacientes con sospecha clínica de tuberculosis. El antígeno -lipoarabinomanana- (LAM) de M. tuberculosis, se detectó por coaglutinación e inmunoensayo en papel (DOT) utilizando suero hiperinmune de conejo y un anticuerpo monoclonal. Para la detección de anticuerpos se usaron dos sistemas de ELISA utilizando en ellos, como antígenos, un extracto soluble de M. tuberculosis y lipoarabinomanana purificada. Los resultados demostraron que la detección del antígeno en estos sistemas fue poco eficiente, para coaglutinación la sensibilidad fue 32 por ciento y la especificidad 81 por ciento, mientras que para DOT fueron 38 por ciento y 84 por ciento respectivamente. La detección por ELISA de anticuerpos utilizando extracto de M tuberculosis mostró una sensibilidad del 80 por ciento con especificidad del 60 por ciento. Con LAM la sensibilidad fue 50 por ciento con especificidad de 90 por ciento. Los resultados anteriores sugieren que el uso de inmunoensayos utilizando sueros de pacientes para la búsqueda de LAM y, para la detección de anticuerpos en contra de estos antígenos, no tiene suficiente especificidad y sensibilidad para ser de utilidad en el diagnóstico rutinario de tuberculosis en población abierta. Es necesario desarrollar métodos rápidos para el diagnóstico de TBP, especialmente en países en desarrollo en los que la prevalencia de TBP es mayor

Infecciones intraahospitalarias: vigilancia epidemiológica en el Instituto Nacional de Enfermedades Respiratorias / Interhospitalary infection: a survellance program in the National Institute of Respiratory Diseases

Las infecciones nosocomiales, por su repercusión en el pronóstico de pacientes, costo y eficiencia del hospital, constituyen un grave problema de salud. En este artículo, se presenta la información obtenida a través de un estudio propectivo de vigilancia epidemiológica durante un años, en el Instituto Nacional de Enfermedades Respiratorias. Los resultados mostraron una razón de 11.5% por 100 egresos, con 78.5% en la unidad de terapia intensiva. Los sitios más frecuentes de infección fueron tracto gastrointestinal, vías urinarias y vías respiratorias. Se comparan estos resultados con otros estudios efectuados en México