TROPION-Lung07: Phase III study of Dato-DXd + pembrolizumab ± platinum-based chemotherapy as 1L therapy for advanced non-small-cell lung cancer.

For patients with advanced/metastatic non-small-cell lung cancer (NSCLC) without actionable genomic alterations and low (<50%) PD-L1 expression, pembrolizumab plus pemetrexed and platinum chemotherapy is a preferred first-line treatment. These patients have comparatively worse outcomes than those with higher PD-L1 expression, underscoring the need for new combination strategies. Datopotamab deruxtecan (Dato-DXd), a TROP2-directed antibody-drug conjugate, has demonstrated encouraging antitumor activity and safety in this patient population. We describe the rationale and design of TROPION-Lung07, a randomized, open-label Phase III study assessing Dato-DXd in combination with pembrolizumab with/without platinum-based chemotherapy versus pembrolizumab plus pemetrexed and platinum-based chemotherapy in patients with advanced/metastatic non-squamous NSCLC without actionable genomic alterations and <50% PD-L1 expression. Primary study objectives are progression-free survival and overall survival.Clinical Trial Registration: NCT05555732 (ClinicalTrials.gov).

Most patients discover they have non-small-cell lung cancer (NSCLC) after it has already spread beyond the lungs (metastasized) making it more challenging to treat. If patients with NSCLC also lack specific genetic changes, called "actionable genomic alterations", or have low levels of a protein called PD-L1 (which cancer cells use to avoid attack from the immune system and continue to grow), current treatments may not fully help, or only help for a while. However, newer approaches are being investigated that may benefit these patients with fewer side effects than traditional chemotherapy. Datopotamab deruxtecan (Dato-DXd) is an investigational drug which combines an antibody with a chemotherapy agent to specifically target and kill cancer cells. The antibody in Dato-DXd attaches to a protein called TROP2, which is widely expressed in NSCLC tumors, and delivers chemotherapy directly into cancer cells to kill them. The TROPION-Lung07 study will assess the potential benefits and side effects of adding Dato-DXd to other drugs, including pembrolizumab (an immunotherapy which attaches to PD-1 on immune cells and triggers the death of cancer cells) and chemotherapy. Three treatment groups will be compared: pembrolizumab with chemotherapy; Dato-DXd with pembrolizumab; and Dato-DXd with pembrolizumab and chemotherapy. The study will help us to understand if adding Dato-DXd to other anticancer drugs allow patients to live longer without their disease getting worse.

Adding Evidence to an Evidence-Based Classification for Recurrent Weight Gain after Bariatric and Metabolic Surgery from a Norwegian National Registry.

BACKGROUND: In 2023, the first evidence-based classification for recurrent weight gain (RWG) after metabolic and bariatric surgery was introduced. It uses early and late follow-up weight loss benchmarks based on standard deviations (SD) of percentage total weight loss(%TWL) results from the large Dutch Audit for Treatment of Obesity (DATO) registry (n > 18,000). We aimed to validate this classification and confirm its clinical relevance with an external cohort. METHODS: The DATO-based classification defines all RWG as grade 1, as long as weight-loss does not drop below DATO's late-follow-up minus one SD benchmark (20%TWL). Grade 3 represents clear outliers whose RWG evolves below DATO's late follow-up minus two SD benchmark (10%TWL), with grade 2 in-between. Grades 2a/3a represent initial suboptimal clinical response, with nadir %TWL never exceeding DATO's early-follow-up minus one SD benchmark (25%TWL). Grades 2b/3b represent late clinical deterioration from nadir weight loss ≥ 25%TWL. We compared baseline characteristics, SD based benchmarks, RWG and comorbidities from the Scandinavian Obesity Surgery Registry Norway (SOReg-N) with these DATO-derived grades. RESULTS: The SOReg-N population (n = 3064) was comparable at baseline, with more sleeve gastrectomies (54% versus DATO 22.5%). The SD benchmarks were at early follow-up minus one SD 25.8%TWL, at 5 years minus one SD/minus two-SD 17.2%TWL/7.0%TWL (DATO 25%TWL/20%TWL/10%TWL). Percentage of patients and amount of RWG were similar to DATO. In line with DATO, comorbidities were predominant in grades 2a/3a, with least improvement in grade 3a. Also, grade 3b showed more favorable characteristics at baseline. CONCLUSION: The SOReg-N cohort confirmed the weight-loss benchmarks defining the DATO-derived grades, the distribution of patients and their RWG across the grades, and correlations between grades and comorbidities. Male gender, older age and comorbidities were predominant among patients with initial suboptimal clinical response (RWG grades 2a/3a), but not for late clinical deterioration (RWG grades 2b/3b). This classification can be used for populations with diverse weight loss trajectories and offers an evidence-based guide for clinical decision-making and standardization.

Preclinical activity of datopotamab deruxtecan, a novel TROP2 directed antibody-drug conjugate targeting trophoblast cell-surface antigen 2 (TROP2) in ovarian carcinoma.

INTRODUCTION: Epithelial ovarian cancer (EOC) is associated with the highest gynecologic cancer mortality. The development of novel, effective combinations of targeted therapeutics remains an unmet medical need. We evaluated the preclinical activity of datopotamab deruxtecan (Dato-Dxd), a novel TROP2 targeting antibody drug conjugate (ADC) in ovarian cancer cell lines and xenografts with variable TROP2 expression. METHODS: In vitro cell viability with Dato-DXd was assessed using flow-cytometry based assays against a panel of EOC primary cell lines with variable TROP2 expression. Fluorescent anti-phospho-histone H2A.X antibody was used to detect dsDNA breaks by flow-cytometry. The in vivo antitumor activity of Dato-DXd was tested in TROP2 overexpressing xenografts. RESULTS: TROP2 overexpressing (3+) and moderate (2+) expressing EOC cell lines demonstrated higher sensitivity to Dato-DXd when compared to TROP2 negative tumors. Dato-DXd exposed TROP2+ EOC demonstrated increased dsDNA breaks and Annexin-V positivity (a marker of apoptosis) when compared to tumor cells exposed to the non-binding conjugate (p = 0.001 and p = 0.016, respectively). Dato-DXd induced significant antibody-dependent cellular cytotoxicity (ADCC) in the presence of peripheral-blood-lymphocytes. While negligible activity was detected against EOC cell lines with low TROP2 expression, Dato-DXd demonstrated significant bystander killing against tumor cells with low/negligible TROP2 when such cells were admixed with TROP2 3+ tumor cells in vitro. Dato-DXd showed tumor growth suppression against EOC cell line derived xenograft models that overexpress TROP2 at 3+ levels, prolonging survival when compared to controls, with minimal toxicity. CONCLUSION: Dato-DXd shows promising preclinical activity against TROP2 overexpressing ovarian cancers. Future clinical trials in ovarian cancer patients are warranted.

Datopotamab deruxtecan: A novel antibody drug conjugate for triple-negative breast cancer.

Triple negative breast cancer (TNBC) represents the breast cancer subtype with least favorable outcome because of the lack of effective treatment options and its molecular features. Recently, ADCs have dramatically changed the breast cancer treatment landscape; the anti-TROP2 ADC Sacituzumab Govitecan has been approved for treatment of previously treated, metastatic TNBC patients. The novel ADC Datopotecan-deruxtecan (Dato-DXd) has recently shown encouraging results for TNBC. In the current paper, we summarize and discuss available data regarding this TROP-2 directed agent mechanism of action and pharmacologic activity, we describe first results on efficacy and safety of the drug and report characteristics, inclusion criteria and endpoints of the main ongoing clinical trials.

Clinical management, monitoring, and prophylaxis of adverse events of special interest associated with datopotamab deruxtecan.

Antibody drug conjugates (ADCs) are an emerging class of treatments designed to improve efficacy and decrease toxicity compared with other systemic therapies through the selective delivery of cytotoxic agents to tumor cells. Datopotamab deruxtecan (Dato-DXd) is a novel ADC comprising a topoisomerase I inhibitor payload and a monoclonal antibody directed to trophoblast cell-surface antigen 2 (TROP2), a protein that is broadly expressed in several types of solid tumors. Dato-DXd is being investigated across multiple solid tumor indications. In the ongoing, first-in-human TROPION-PanTumor01 phase I study (ClinicalTrials.gov: NCT03401385), encouraging and durable antitumor activity and a manageable safety profile was demonstrated in patients with advanced/metastatic hormone receptor-positive/human epidermal growth factor receptor2-negative breast cancer (HR+/HER2- BC), triple-negative breast cancer (TNBC), and non-small cell lung cancer (NSCLC). Improved understanding of the adverse events (AEs) that are associated with Dato-DXd and their optimal management is essential to ensure safe and successful administration. Interstitial lung disease/pneumonitis, infusion-related reactions, oral mucositis/stomatitis, and ocular surface events have been identified as AEs of special interest (AESIs) for which appropriate prevention, monitoring, and management is essential. This article summarizes the incidence of AESIs among patients with HR+/HER2- BC, TNBC, and NSCLC reported in TROPION-PanTumor01. We report our recommendations for AESI prophylaxis, early detection, and management, using experience gained from treating AESIs that occur with Dato-DXd in clinical trials.

TROPION-Breast01: Datopotamab deruxtecan vs chemotherapy in pre-treated inoperable or metastatic HR+/HER2- breast cancer.

Improving the prognosis for patients with metastatic HR+/HER2- breast cancer remains an unmet need. Patients with tumors that have progressed on endocrine therapy and/or are not eligible for endocrine therapy had limited treatment options beyond chemotherapy. Antibody-drug conjugates are a novel and promising treatment class in this setting. Datopotamab deruxtecan (Dato-DXd) consists of a TROP2-directed humanized IgG1 monoclonal antibody attached via a serum-stable cleavable linker to a topoisomerase I inhibitor payload. TROPION-Breast01 is an ongoing phase III study that is evaluating the efficacy and safety of Dato-DXd compared with investigator's choice of standard-of-care chemotherapy in patients with inoperable or metastatic HR+/HER2- breast cancer who have received one or two prior lines of systemic chemotherapy in the inoperable or metastatic setting. Clinical Trial Registration: NCT05104866 (ClinicalTrials.gov).

Antibody-drug conjugates are a type of drug with two parts: an antibody that directs the drug to the cancer cells and a cancer-cell killing toxic payload. By binding to cancer cells before releasing the payload, treatment is directed to the site of action so there are fewer side effects in the rest of the body. Datopotamab deruxtecan (Dato-DXd) is an antibody-drug conjugates made up of datopotamab (antibody) and DXd (payload) which are joined together via a stable linker. Datopotamab binds to a protein found on cancer cells called TROP2; it then goes inside and releases the DXd payload to kill the tumor cells. DXd may leak out to surrounding cancer cells and kill those as well. The TROPION-Breast01 study is comparing Dato-DXd with standard-of-care chemotherapy. Around 700 patients will take part, who have: Tumors that cannot be surgically removed. Tumors that are hormone receptor-positive and do not have HER2 overexpression. Had one or two lines of previous chemotherapy (after the tumor could not be surgically removed, or had spread). Had tumor growth despite hormonal therapy or are ineligible for hormonal therapy. Patients who meet the entry criteria will be randomly assigned to a treatment group in equal numbers to either Dato-DXd or an appropriate chemotherapy, out of four options chosen by the treating doctor. At the end of the study, researchers will look at whether the patients who receive Dato-DXd live longer without their breast cancer getting worse, compared with patients who receive chemotherapy. This study is also looking at how the treatment affects patients' quality of life.

DATA GOVERNANCE in digital surgery.

Technological and computer advances have led to a "new era" of Surgery called Digital Surgery. In it, the management of information is the key. The development of Artificial Intelligence requires "Big Data" to create its algorithms. The use of digital technology for the systematic capture of data from the surgical process raises ethical issues of privacy, property, and consent. The use of these out-of-control data creates uncertainty and can be a source of mistrust and refusal by surgeons to allow its use, requiring a framework for the correct management of them. This paper exposes the current situation of Data Governance in Digital Surgery, the challenges posed and the lines of action necessary to resolve the areas of uncertainty that have arisen in the process, in which the surgeon must play a relevant role.

Sequencing Antibody Drug Conjugates in Breast Cancer: Exploring Future Roles.

Antibody drug conjugates (ADCs) have emerged as a highly effective treatment strategy across breast cancer (BC) subtypes, including human epidermal growth factor receptor 2-positive (HER2+), hormone-receptor positive (ER/PR+), and triple-negative breast cancer (TNBC). Over the past twenty years, ADCs have undergone relevant evolutions, from target diversity to payload ratio, to linker design, allowing for a progressive increase in their efficacy. From the first-generation ADC, trastuzumab emtansine (T-DM1), approved in 2013 for HER2+ breast cancer, to next generation ADCs such as sacituzumab govitecan and trastuzumab deruxtecan, to emerging ADCs on the horizon, we continue to see unparalleled efficacy compared to traditional chemotherapy. However, each ADC has brought a new cadre of adverse events for clinicians and patients to manage. Importantly, with the development and approval of several ADCs to treat metastatic breast cancer, there are unanswered clinical questions surrounding how to optimally sequence treatment for patients who may be candidates for more than one ADC and, in general, how to treat patients beyond progression on ADCs. From bench to bedside, in this review, we will discuss the pharmacology and current indications for the novel ADCs trastuzumab deruxtecan and sacituzumab govitecan. Highlighting emerging ADCs and ongoing clinical trials, we will anticipate the changes in the breast cancer treatment paradigm. Lastly, we will outline the available data and current approaches for adverse event management and sequencing strategies for ADCs in clinical practice, including proposed mechanisms of resistance.

Safety evaluation of Datopotamab deruxtecan for triple-negative breast cancer: a meta-analysis.

BACKGROUND: TROP-2 is emerging as a valid and fruitful strategy in triple-negative breast cancer (TNBC) patients, and several agents are currently under evaluation, including Datopotamab deruxtecan (Dato-DXd). RESEARCH DESIGN AND METHODS: Herein, we performed a meta-analysis aimed to evaluate any grade adverse events, grade 3-4 adverse events, dose reduction, and serious adverse events in TNBC patients treated with Dato-DXd in clinical trials. RESULTS: The pooled results suggests that Dato-DXd is associated with a favorable safety profile: while any grade treatment-related toxicities were common, grade 3-4 events were not particularly frequent and mainly represented by stomatitis (13.88%; 95% CI, 10.68 - 17.09). CONCLUSIONS: These findings may help to comprehensively define the safety profile of Dato-DXd and to assist in the design of future clinical trials in this setting.

TROPION-Breast02: Datopotamab deruxtecan for locally recurrent inoperable or metastatic triple-negative breast cancer.

Despite recent treatment advances, the prognosis for patients with locally recurrent inoperable or metastatic triple-negative breast cancer (TNBC) remains poor. The antibody-drug conjugate datopotamab deruxtecan (Dato-DXd) is composed of a humanized anti-TROP2 IgG1 monoclonal antibody linked to a topoisomerase I inhibitor payload via a stable, cleavable linker. The phase III TROPION-Breast02 trial in patients previously untreated for locally recurrent inoperable or metastatic TNBC, who are not candidates for PD-1/PD-L1 inhibitors is evaluating efficacy and safety of Dato-DXd versus investigator's choice of chemotherapy (ICC). Approximately 600 patients will be randomized 1:1 to Dato-DXd 6 mg/kg iv. every 3 weeks or ICC (paclitaxel, nab-paclitaxel, carboplatin, capecitabine or eribulin mesylate). Dual primary end points are progression-free survival by blinded independent central review and overall survival.

Triple-negative breast cancer (TNBC) is a subtype of breast cancer that is hard to treat. Tumors lack receptors for estrogen and progesterone, which means that standard endocrine therapy is ineffective, and it does not express HER2, so HER2 therapies are also not appropriate. However, the majority of TNBC tumors do possess a cell surface protein called TROP2 which provides a way of directing treatment inside tumor cells that is more selective than traditional chemotherapy. Datopotamab deruxtecan (Dato-DXd) is a drug that consists of two parts: datopotamab (an antibody) and DXd (the cancer-cell killing toxic component), which are joined via a stable linker. Datopotamab binds to the TROP2 protein found on TNBC tumors and is taken into the cell. The linker is then broken and releases DXd, which kills the tumor cell. By binding to cancer cells before releasing the payload, treatment is directed to the tumor, minimizing side effects in the rest of the body. The TROPION-Breast02 study aims to discover whether Dato-DXd is more effective than standard-of-care chemotherapy, allowing patients with TNBC to live longer without their breast cancer getting worse. This study is also looking at how Dato-DXd may affect patients' overall functioning and quality of life. TROPION-Breast02 will recruit approximately 600 patients who: Have cancer that has spread from the original site (metastatic), or cancer that returned to the same site (locally recurrent) that cannot be surgically removed Have not received any prior treatment for this stage of cancer Cannot receive an alternative type of anticancer treatment called PD-(L)1 inhibitors Had any length of time between their last treatment with the aim of cure and return of their disease Eligible patients will be randomly assigned to a treatment group in equal numbers to either Dato-DXd or an appropriate chemotherapy (one of five available options, chosen by the treating doctor). Each patient will generally continue to receive their designated treatments if the tumor is controlled by the drug, there are no unacceptable side effects, or the patient chooses to stop treatment. Clinical Trial Registration: NCT05374512 (ClinicalTrials.gov).

TROPION-Lung08: phase III study of datopotamab deruxtecan plus pembrolizumab as first-line therapy for advanced NSCLC.

Pembrolizumab monotherapy is a standard first-line treatment for PD-L1-high advanced non-small-cell lung cancer (NSCLC) without actionable genomic alterations (AGA). However, few patients experience long-term disease control, highlighting the need for more effective therapies. Datopotamab deruxtecan (Dato-DXd), a novel trophoblast cell-surface antigen 2-directed antibody-drug conjugate, showed encouraging safety and antitumor activity with pembrolizumab in advanced NSCLC. We describe the rationale and design of TROPION-Lung08, a phase III study evaluating safety and efficacy of first-line Dato-DXd plus pembrolizumab versus pembrolizumab monotherapy in patients with advanced/metastatic NSCLC without AGAs and with PD-L1 tumor proportion score ≥50%. Primary end points are progression-free survival and overall survival; secondary end points include objective response rate, duration of response, safety and presence of antidrug antibodies. Clinical trial registration: NCT05215340 (ClinicalTrials.gov).

More than half of patients with non-small-cell lung cancer (NSCLC) are diagnosed when their tumor is advanced (unlikely to be cured with currently available treatments) or metastatic (spread to other parts of the body). These patients have poor survival outcomes. NSCLCs can grow by using a protein called PD-L1 to escape from the immune system. Pembrolizumab is an immunotherapy that targets PD-1, the protein on immune cells that detects PD-L1. Because of this, pembrolizumab prevents the tumor from escaping the immune system by blocking the interaction of PD-L1 with PD-1. Patients whose NSCLC tumors express PD-L1 often respond to pembrolizumab at first but, for most of these patients, their cancer eventually comes back. An investigational drug called datopotamab deruxtecan (Dato-DXd) is a type of therapy called an antibody­drug conjugate that delivers chemotherapy to tumors using an antibody. The antibody in Dato-DXd is directed against a protein called TROP2, which is commonly expressed by tumor cells. Results from early studies show that combining pembrolizumab with Dato-DXd may work well for patients with solid tumors, including NSCLC. This study will look at the benefits and side effects of Dato-DXd added to pembrolizumab compared with pembrolizumab alone as a first treatment option for patients with advanced NSCLC and high levels of PD-L1.

Evidence-Based Classification for Post-bariatric Weight Regain from a Benchmark Registry Cohort of 18,403 Patients and Comparison with Current Criteria.

INTRODUCTION: There is a need for a standardized, evidence-based classification of post-bariatric weight-regain, to investigate and compare revision procedures and to advice and treat patients in an evidence-based way. METHODS: We used standard deviations (SD) of the highest (1-2 years) and latest (> 2 years) percentage total weight loss (%TWL) results after primary bariatric surgery from the Dutch Audit for Treatment of Obesity (DATO) bariatric registry as benchmarks for (above) average (≥ - 1SD), poor (- 1SD to - 2SD) and insufficient (< - 2SD) weight loss. Weight regain maintaining (above) average weight loss was called grade 1, weight regain towards poor weight loss grade 2, towards insufficient weight loss grade 3, with subgrades 2a/3a for below average weight loss from the start, and 2b/3b for weight regain from (above) average to below average weight loss. Patient characteristics and diabetes improvement/impairment were compared. Sensitivity and specificity of 14 existing weight regain criteria were calculated. RESULTS: We analyzed 93,465 results from 38,830 patients (77.1% gastric bypass, 22.5% sleeve gastrectomy). The - 1SD thresholds for early and late weight loss approximated 25%TWL and 20%TWL, the - 2SD threshold for late weight loss 10%TWL. Weight regain could be analyzed for 18,403 patients (2.5-5.2 years follow-up). They regained mean 6.7 kg (5.4%TWL), with 66.8% grade 1 weight regain, 7.2% grade 2a, 7.4% grade 2b, 2.1% grade 3a, and 0.6% grade 3b. There were significant differences in comorbidities, gender, age, weight regain, diabetes impairment, and diabetes improvement across grades. Weight regain criteria from literature were extremely divers. None had high sensitivity. CONCLUSION: The DATO classification for post-bariatric weight regain combines the extent of weight regain with evidence-based endpoints of weight loss. It differentiated weight regain maintaining (above) average weight loss, two intermediate grades, gradual weight regain with below average weight loss from the start (primary non-response) and steep weight regain towards insufficient weight loss (secondary non-response). The classification is superior to existing criteria and well supported by evidence.

Predicting serious complication risks after bariatric surgery: external validation of the Michigan Bariatric Surgery Collaborative risk prediction model using the Dutch Audit for Treatment of Obesity.

BACKGROUND: Risk-prediction tools can support doctor-patient (shared) decision making in clinical practice by providing information on complication risks for different types of bariatric surgery. However, external validation is imperative to ensure the generalizability of predictions in a new patient population. OBJECTIVE: To perform an external validation of the risk-prediction model for serious complications from the Michigan Bariatric Surgery Collaborative (MBSC) for Dutch bariatric patients using the nationwide Dutch Audit for Treatment of Obesity (DATO). SETTING: Population-based study, including all 18 hospitals performing bariatric surgery in the Netherlands. METHODS: All patients registered in the DATO undergoing bariatric surgery between 2015 and 2020 were included as the validation cohort. Serious complications included, among others, abdominal abscess, bowel obstruction, leak, and bleeding. Three risk-prediction models were validated: (1) the original MBSC model from 2011, (2) the original MBSC model including the same variables but updated to more recent patients (2015-2020), and (3) the current MBSC model. The following predictors from the MBSC model were available in the DATO: age, sex, procedure type, cardiovascular disease, and pulmonary disease. Model performance was determined using the area under the curve (AUC) to assess discrimination (i.e., the ability to distinguish patients with events from those without events) and a graphical plot to assess calibration (i.e., whether the predicted absolute risk for patients was similar to the observed prevalence of the outcome). RESULTS: The DATO validation cohort included 51,291 patients. Overall, 986 patients (1.92%) experienced serious complications. The original MBSC model, which was extended with the predictors "GERD (yes/no)," "OSAS (yes/no)," "hypertension (yes/no)," and "renal disease (yes/no)," showed the best validation results. This model had a good calibration and an AUC of .602 compared with an AUC of .65 and moderate to good calibration in the Michigan model. CONCLUSION: The DATO prediction model has good calibration but moderate discrimination. To be used in clinical practice, good calibration is essential to accurately predict individual risks in a real-world setting. Therefore, this model could provide valuable information for bariatric surgeons as part of shared decision making in daily practice.

Conversion to Roux-en-Y gastric bypass versus one-anastomosis gastric bypass after a failed primary gastric band: a matched nationwide study.

BACKGROUND: Primary laparoscopic adjustable gastric band (LAGB) has high rates of patients not achieving the desired weight loss, and it remains unclear which bariatric conversion procedure gives better results. OBJECTIVE: To compare weight loss among patients undergoing conversion one-anastomosis gastric bypass (cOAGB) and conversion Roux-en-Y gastric bypass (cRYGB) after a failed LAGB. SETTING: Nationwide population-based study including all 18 hospitals providing metabolic and bariatric surgery. METHODS: Patients with a failed primary LAGB who underwent a cRYGB or cOAGB between January 1, 2015, and December 31, 2019, were selected from the Dutch Audit for Treatment of Obesity. The primary outcome was not achieving ≥20% total weight loss (TWL) at 1-year and up to 5-year follow-up. Secondary outcomes included postoperative complications, defined as Clavien-Dindo ≥III within 30 days, and co-morbidity remission. A propensity score matched logistic and Poisson regression model was used to estimate the difference in patients not achieving ≥20% TWL between cRYGB and cOAGB. RESULTS: A total of 615 (78.7%) patients underwent cRYGB, and 166 (21.3%) patients underwent cOAGB, with 163 patients successfully matched. Both groups had similar rates of patients not achieving ≥20% TWL at 1 year (odds ratio [OR] = .64, 95% confidence interval [CI]: .38-1.05). However, a sensitivity analysis showed that patients undergoing cOAGB had lower rates of patients not achieving ≥20% TWL up to 5-year follow-up (rate ratio = .69, 95% CI: .51-.95, P < .05). Patients undergoing cOAGB were less likely to achieve hypertension remission (OR = .22, 95% CI: .07-.66). There were no significant differences between groups in postoperative complications (OR = .39, 95% CI: .07-2.06, P > .05). CONCLUSION: This matched nationwide study suggests that the cOAGB has similar short-term weight loss outcomes but potentially better long-term weight loss results than cRYGB. Therefore, cOAGB could provide a reliable alternative but needs to be substantiated in future long-term studies.

Una mirada a la cibercriminalidad en Colombia y su asimilación con los delitos de impacto / A look at cybercrime in Colombia and its assimilation with impact crime / Um olhar sobre o crime cibernético na Colômbia e sua assimilação com o crime de impacto

El presente artículo tiene como objetivo realizar una reflexión, respecto de la asimilación que deberían tener los delitos informáticos en relación con los tipos penales que históricamente han sido catalogados como delitos de impacto (homicidio, secuestro, lesiones personales, hurto), para determinar que los delitos de carácter informático requieren un tratamiento diferencial, mayor conocimiento y estrategias tendientes a mejorar las medidas de prevención y autoprotección en la sociedad. Por consiguiente, el estudio fue abordado a partir de una metodología descriptiva con enfoque analítico cuantitativo de los registros estadísticos de las conductas punibles registradas en el Sistema de Información Estadístico Delictivo y Contravencional de la Policía Nacional de Colombia - SIEDCO, para concluir, el estudio logra demostrar que los delitos informáticos no han tenido la misma trascendencia, a pesar de que últimamente y en forma reiterada los medios de comunicación registran noticias relacionadas con el incremento de este fenómeno criminógeno.

Based on an exploratory methodology with a quantitative analytical approach to the statistical records of punishable conducts registered in the Statistical Information System on Crime and Misdemeanours of the National Police of Colombia - SIEDCO, this article aims to demonstrate the assimilation of computer crimes typified by the legislator with impact crimes, to show that criminal offences of a computer nature require differential treatment, greater knowledge and strategies aimed at improving prevention measures and self-protection of society. The above considering that crime is undoubtedly one of the phenomena that most affects society in general and often, the political-administrative authorities, police and experts in public safety, tend to consider homicide, kidnapping, personal injury, rape and theft, which have been commonly classified as impact crimes, to be of greater importance. In conclusion, the study demonstrates that cybercrime has not had the same importance, despite the fact that the media have recently and repeatedly reported news related to the increase in this criminogenic phenomenon.

Baseado em uma metodologia exploratória com abordagem analítica quantitativa dos registros estatísticos de condutas puníveis registrados no Sistema de Informação Estatística sobre Crimes e Delitos da Polícia Nacional da Colômbia - SIEDCO, este artigo visa demonstrar a assimilação dos crimes informáticos tipificados pelo legislador com crimes de impacto, para mostrar que os delitos de natureza informática requerem tratamento diferenciado, maior conhecimento e estratégias destinadas a melhorar as medidas de prevenção e auto-proteção da sociedade.O acima exposto, considerando que o crime é sem dúvida um dos fenômenos que mais afeta a sociedade em geral e, muitas vezes, as autoridades político-administrativas, a polícia e os especialistas em segurança pública, tendem a considerar de maior importância os homicídios, seqüestros, danos pessoais, estupros e roubos, que têm sido comumente classificados como crimes de impacto. Para concluir, o estudo consegue demonstrar que os crimes informáticos não têm tido a mesma transcendência, apesar do fato de que ultimamente e repetidamente a mídia registra notícias relacionadas com o aumento deste fenômeno criminogênico.

Measuring quality of life in bariatric surgery: a multicentre study.

BACKGROUND: Current studies mainly focus on total weight loss and comorbidity reduction. Only a few studies compare Quality of Life (QoL) after sleeve gastrectomy (SG) and Roux-en-Y gastric bypass (RYGB). This study was conducted to examine the extent of improvement in QoL on different domains after primary bariatric surgery and compare these results to Dutch reference values. METHODS: The study included prospectively collected data from patients who underwent primary bariatric surgery in five Dutch hospitals. The RAND-36 questionnaire was used to measure the patient's QoL; preoperatively and twelve months postoperatively. Postoperative scores were compared to Dutch reference values, standardized for age, using t-test. A difference of more than 5% was considered a minimal important difference. A multivariate linear regression analysis was used to compare SG and RYGB on the extent of improvement, adjusted for case-mix factors. RESULTS: In total, 4864 patients completed both the pre- and postoperative questionnaire. Compared with Dutch reference values, patients postoperatively reported clinically relevant better physical functioning (RYGB + 6.8%), physical role limitations (SG + 5.6%; RYGB + 6.2%) and health change (SG + 77.1%; RYGB + 80.0%), but worse general health perception (SG - 22.8%; RYGB - 17.0%). Improvement in QoL was similar between SG and RYGB, except for physical functioning (ß 2.758; p-value 0.008) and general health perception (ß 2.607; p-value < 0.001) for which RYGB patients improved more. CONCLUSIONS: SG and RYGB patients achieved a better postoperative score in physical functioning, physical role limitations and health change compared to Dutch reference values, and a worse score in general health perception.

Textbook Outcome: an Ordered Composite Measure for Quality of Bariatric Surgery.

INTRODUCTION: Textbook outcome (TO) studies have previously shown that a composite measure can provide additional information on the overall quality of surgical care. However, these were binominal outcomes which do not give individual hospitals the required information on how to improve their performance. The aim of this study is to create an ordered TO consisting of multiple outcome parameters for bariatric surgery to assess the extent of hospital variation. METHODS: Patients who underwent a primary bariatric procedure in the Netherlands were included for analyses. The outcomes were ordered as mortality, severe postoperative complications, readmission, mild complications and prolonged length of stay (LOS) within 30 days after primary surgery with TO defined as none of these outcomes occurring. Hospitals were identified with a significantly higher or lower observed/expected ratio than expected based on case-mix and the extent of hospital variation was expressed as the median and interquartile range (IQR). RESULTS: From a total of 27,360 patients on average, 88.7% reached TO (range 35.5-96.9%). Two hospitals had less than expected TO due to more prolonged LOS (57.6%) in one hospital and more mild complications in another (17.1%). Hospital variation was much smaller for TO (median OR 0.91 IQR [0.62-1.06]) than for an ordered TO (median POR 0.66 IQR [0.55-0.96]). CONCLUSION: Using the ordered TO for bariatric surgery, more hospital variation was captured thereby enabling individual hospitals to identify which outcomes and specific groups need improvement. This could attribute to the ongoing effort to improve the quality of the outcome of bariatric surgery.

Perioperative Outcomes of Primary Bariatric Surgery in North-Western Europe: a Pooled Multinational Registry Analysis.

INTRODUCTION: The global prevalence of obesity has increased in recent decades, and bariatric surgery has become a part of the treatment algorithm of obesity. National high-quality registries enable large-scale evaluations of the use and outcome of bariatric surgery and may allow for improved knowledge. The main objective was to evaluate the rate and type of complications after primary bariatric surgery in three North-Western European countries using nationwide registries. MATERIALS AND METHODS: Data from three registries for bariatric surgery were used (January 2015-December 2016). All registries have nationwide coverage with data on patient characteristics, obesity-related diseases, surgical technique, complications, grading of complications, reinterventions, readmissions, and mortality. Eligibility criteria for bariatric surgery were similar and included body mass index of ≥ 40.0 or ≥ 35.0 kg/m2, with one or more obesity-associated diseases. RESULTS: A total of 35,858 procedures (32,177 primary) were registered. The most common procedure was gastric bypass in the Netherlands (78.9%) and Sweden (67.0%), and sleeve gastrectomy in Norway (58.2%). A total of 904 (2.8%) patients developed major complications after primary surgery and 12 patients (0.04%) died within 30 days. Total number of complications between the registries were comparable (p = 0.939). However, significant differences were seen for Clavien-Dindo Classification grades IIIb and IV (p < 0.001). Pooled readmission rates were 4.3% (n = 1386). DISCUSSION: Bariatric surgery is safely performed in the three evaluated countries. Standardization of registries and consensus of variables are essential for international comparison and may contribute to improved quality of treatment across nations.

Quality of death certification in Colombia / Calidad de la certificación de la muerte en Colombia

Abstract Objective: To evaluate the quality of the certification of general death and cancer in Colombia. Methods: Validity indicators were described for each province and the cities of Bogotá, Cali, Manizales, Pasto and Bucaramanga. A factorial analysis of principal components was carried out in order to identify non-obvious relationships. Results: Were analyzed 984,159 deaths, among them there were 164,542 deaths due to cancer. 93.7% of the general mortality was well certified. The predominant errors were signs, symptoms and ill-defined conditions. 92.8% of cancer mortality was well certified. The predominant errors were due to poorly defined cancer sites. Conclusions: Certification of quality indicators in Colombia has improved. Given the good performance of the quality indicators for certificating general death and cancer, it is considered that this is a valid input for the estimation of cancer incidences.

Resumen Objetivo: Evaluar la calidad de la certificación de la muerte general y por cáncer en Colombia. Métodos: Se describieron indicadores de validez para cada departamento y las ciudades de Bogotá, Cali, Manizales, Pasto y Bucaramanga. Se realizó un análisis factorial de componentes principales con el fin de identificar relaciones no evidentes. Resultados: Se analizaron 984,159 defunciones, dentro de las cuales había 164,542 muertes por cáncer. El 93.7% de la mortalidad general estaba bien certificada. Los errores predominantes fueron signos, síntomas y afecciones mal definidas. El 92.8% de la mortalidad por cáncer estaba bien certificada. Los errores predominantes fueron cánceres de sitio mal definido. Conclusiones: Los indicadores de calidad de certificación en Colombia mejoraron. Ante el buen comportamiento de los indicadores de calidad de la certificación de la muerte general y por cáncer, se considera que ésta es un insumo válido para la estimación de incidencia de cáncer.

A Dutch Nationwide Bariatric Quality Registry: DATO.

INTRODUCTION: In the Netherlands, the number of bariatric procedures increased exponentially in the 90s. To ensure and improve the quality of bariatric surgery, the nationwide Dutch Audit for Treatment of Obesity (DATO) was established in 2014. The audit was coordinated by the Dutch Institute for Clinical Auditing (DICA). This article provides a review of the aforementioned process in establishing a nationwide registry in the Netherlands. MATERIALS AND METHODS: In collaboration with the DATO's scientific committee and other stakeholders, an annual list of several external quality indicators was formulated. This list consists of volume, process, and outcome indicators. In addition to the annual external indicators, the database permits individual hospitals to analyze their own data. The dashboard provides several standardized reports and detailed quality indicators, which are updated on a weekly base. RESULTS: Since the start, all 18 Dutch bariatric centers participated in the nationwide audit. A total of 21,941 cases were registered between 2015 and 2016. By 2016, the required variables were registered in 94.3% of all cases. A severe complicated course was seen in 2.87%, and mortality in 0.05% in 2016. The first-year follow-up shows a > 20% TWL in 86.1% of the registered cases. DISCUSSION: The DATO has become rapidly a mature registry. The well-organized structure of the national audit institution DICA and governmental funding were essential. However, most important were the bariatric teams themselves. The authors believe reporting the results from the registry has already contributed to more knowledge and acceptance by other health care providers.