Pseudonymisation in the context of GDPR-compliant medical research

Pseudonymisation is a data protection technique often used to protect the privacy of individuals when their personal data are being used for research purposes. Not only is it a key ingredient of the General Data Protection Regulation (GDPR) that requires organisations to ensure that the personal data they process is handled in a secure manner, but it is particularly important in assisting medical research given that often relies on sensitive personal data, since it reduces the risk that medical data could be misused or mishandled. For managing their medical data, it is important to ensure that such data are protected against unauthorised access, and can be reutilised in an anonymous fashion, while still authorised personnel is able to identify the study participant that some data belong to (e.g., for personalised interventions, technical alerts, technical support). In addition, the re-identification of a study participant is a pre-requisite for exercising their rights under the GDPR, since it assists organisations in meeting GDPR requirements (such as the right to access, rectify and portability of data). We argue that the application of pseudonymisation is particularly effective when considered during the early stages (Privacy by Design) of digital services implementation, as well as when defining the complementary to these organizational procedures. Aim of this paper is to present the way in which the pseudonymisation mechanism of the SMART BEAR H2020 project supports the triptych of research activities conducted within the context of an observational medical study, legal obligations arising from the regulatory framework for the protection of personal data, and reutilisation of data for research purposes. Evidence-based security and privacy assessments will be conducted on two different H2020 projects to evaluate such privacy practice

Elective cancer surgery in COVID-19-free surgical pathways during the SARS-CoV-2 pandemic: An international, multicenter, comparative cohort study

PURPOSE As cancer surgery restarts after the first COVID-19 wave, health care providers urgently require data to determine where elective surgery is best performed. This study aimed to determine whether COVID-19–free surgical pathways were associated with lower postoperative pulmonary complication rates compared with hospitals with no defined pathway. PATIENTS AND METHODS This international, multicenter cohort study included patients who underwent elective surgery for 10 solid cancer types without preoperative suspicion of SARS-CoV-2. Participating hospitals included patients from local emergence of SARS-CoV-2 until April 19, 2020. At the time of surgery, hospitals were defined as having a COVID-19–free surgical pathway (complete segregation of the operating theater, critical care, and inpatient ward areas) or no defined pathway (incomplete or no segregation, areas shared with patients with COVID-19). The primary outcome was 30-day postoperative pulmonary complications (pneumonia, acute respiratory distress syndrome, unexpected ventilation). RESULTS Of 9,171 patients from 447 hospitals in 55 countries, 2,481 were operated on in COVID-19–free surgical pathways. Patients who underwent surgery within COVID-19–free surgical pathways were younger with fewer comorbidities than those in hospitals with no defined pathway but with similar proportions of major surgery. After adjustment, pulmonary complication rates were lower with COVID-19–free surgical pathways (2.2% v 4.9%; adjusted odds ratio [aOR], 0.62; 95% CI, 0.44 to 0.86). This was consistent in sensitivity analyses for low-risk patients (American Society of Anesthesiologists grade 1/2), propensity score–matched models, and patients with negative SARS-CoV-2 preoperative tests. The postoperative SARS-CoV-2 infection rate was also lower in COVID-19–free surgical pathways (2.1% v 3.6%; aOR, 0.53; 95% CI, 0.36 to 0.76). CONCLUSION Within available resources, dedicated COVID-19–free surgical pathways should be established to provide safe elective cancer surgery during current and before future SARS-CoV-2 outbreaks

Elective Cancer Surgery in COVID-19-Free Surgical Pathways During the SARS-CoV-2 Pandemic: An International, Multicenter, Comparative Cohort Study.

PURPOSE: As cancer surgery restarts after the first COVID-19 wave, health care providers urgently require data to determine where elective surgery is best performed. This study aimed to determine whether COVID-19-free surgical pathways were associated with lower postoperative pulmonary complication rates compared with hospitals with no defined pathway. PATIENTS AND METHODS: This international, multicenter cohort study included patients who underwent elective surgery for 10 solid cancer types without preoperative suspicion of SARS-CoV-2. Participating hospitals included patients from local emergence of SARS-CoV-2 until April 19, 2020. At the time of surgery, hospitals were defined as having a COVID-19-free surgical pathway (complete segregation of the operating theater, critical care, and inpatient ward areas) or no defined pathway (incomplete or no segregation, areas shared with patients with COVID-19). The primary outcome was 30-day postoperative pulmonary complications (pneumonia, acute respiratory distress syndrome, unexpected ventilation). RESULTS: Of 9,171 patients from 447 hospitals in 55 countries, 2,481 were operated on in COVID-19-free surgical pathways. Patients who underwent surgery within COVID-19-free surgical pathways were younger with fewer comorbidities than those in hospitals with no defined pathway but with similar proportions of major surgery. After adjustment, pulmonary complication rates were lower with COVID-19-free surgical pathways (2.2% v 4.9%; adjusted odds ratio [aOR], 0.62; 95% CI, 0.44 to 0.86). This was consistent in sensitivity analyses for low-risk patients (American Society of Anesthesiologists grade 1/2), propensity score-matched models, and patients with negative SARS-CoV-2 preoperative tests. The postoperative SARS-CoV-2 infection rate was also lower in COVID-19-free surgical pathways (2.1% v 3.6%; aOR, 0.53; 95% CI, 0.36 to 0.76). CONCLUSION: Within available resources, dedicated COVID-19-free surgical pathways should be established to provide safe elective cancer surgery during current and before future SARS-CoV-2 outbreaks

The impact of surgical delay on resectability of colorectal cancer: An international prospective cohort study

AIM: The SARS-CoV-2 pandemic has provided a unique opportunity to explore the impact of surgical delays on cancer resectability. This study aimed to compare resectability for colorectal cancer patients undergoing delayed versus non-delayed surgery. METHODS: This was an international prospective cohort study of consecutive colorectal cancer patients with a decision for curative surgery (January-April 2020). Surgical delay was defined as an operation taking place more than 4 weeks after treatment decision, in a patient who did not receive neoadjuvant therapy. A subgroup analysis explored the effects of delay in elective patients only. The impact of longer delays was explored in a sensitivity analysis. The primary outcome was complete resection, defined as curative resection with an R0 margin. RESULTS: Overall, 5453 patients from 304 hospitals in 47 countries were included, of whom 6.6% (358/5453) did not receive their planned operation. Of the 4304 operated patients without neoadjuvant therapy, 40.5% (1744/4304) were delayed beyond 4 weeks. Delayed patients were more likely to be older, men, more comorbid, have higher body mass index and have rectal cancer and early stage disease. Delayed patients had higher unadjusted rates of complete resection (93.7% vs. 91.9%, P = 0.032) and lower rates of emergency surgery (4.5% vs. 22.5%, P < 0.001). After adjustment, delay was not associated with a lower rate of complete resection (OR 1.18, 95% CI 0.90-1.55, P = 0.224), which was consistent in elective patients only (OR 0.94, 95% CI 0.69-1.27, P = 0.672). Longer delays were not associated with poorer outcomes. CONCLUSION: One in 15 colorectal cancer patients did not receive their planned operation during the first wave of COVID-19. Surgical delay did not appear to compromise resectability, raising the hypothesis that any reduction in long-term survival attributable to delays is likely to be due to micro-metastatic disease

Outcomes from elective colorectal cancer surgery during the SARS-CoV-2 pandemic

This study aimed to describe the change in surgical practice and the impact of SARS-CoV-2 on mortality after surgical resection of colorectal cancer during the initial phases of the SARS-CoV-2 pandemic

An Automated Prognostic Model for Pancreatic Ductal Adenocarcinoma

Pancreatic ductal adenocarcinoma (PDAC) constitutes a leading cause of cancer-related mortality despite advances in detection and treatment methods. While computed tomography (CT) serves as the current gold standard for initial evaluation of PDAC, its prognostic value remains limited, as it relies on diagnostic stage parameters encompassing tumor size, lymph node involvement, and metastasis. Radiomics have recently shown promise in predicting postoperative survival of PDAC patients; however, they rely on manual pancreas and tumor delineation by clinicians. In this study, we collected a dataset of pre-operative CT scans from a cohort of 40 PDAC patients to evaluate a fully automated pipeline for survival prediction. Employing nnU-Net trained on an external dataset, we generated automated pancreas and tumor segmentations. Subsequently, we extracted 854 radiomic features from each segmentation, which we narrowed down to 29 via feature selection. We then combined these features with the Tumor, Node, Metastasis (TNM) system staging parameters, as well as the patient’s age. We trained a random survival forest model to perform an overall survival prediction over time, as well as a random forest classifier for the binary classification of two-year survival, using repeated cross-validation for evaluation. Our results exhibited promise, with a mean C-index of 0.731 for survival modeling and a mean accuracy of 0.76 in two-year survival prediction, providing evidence of the feasibility and potential efficacy of a fully automated pipeline for PDAC prognostication. By eliminating the labor-intensive manual segmentation process, our streamlined pipeline demonstrates an efficient and accurate prognostication process, laying the foundation for future research endeavors

Obstructive jaundice due to ampullary metastasis of renal cell carcinoma

Renal cell carcinoma is often characterized by the presence of metachronous metastases in unusual sites. The presence of isolated metastases is treated with surgical excision with good anticipated results. On the other hand, systemic chemotherapy is administered in the context of metastatic spread, usually sunitib or sorafenib. In such cases, however, the presence of symptomatic foci calls for minimal intervention. We present a case of a 77-year-old patient who presented with obstructive jaundice due to an ampullary mass. Endoscopic excision and biopsy set the diagnosis of metastatic renal cell carcinoma. Consequently, imaging studies revealed the presence of multiple foci in the lungs and bone. Therefore, pancreatoduodenectomy was excluded and the patient underwent endoscopic ampullectomy and was set to oral sunitinib. Interestingly, despite generalized spread, local control was achieved until the patient succumbed to carcinomatosis.Painless obstructive jaundice in a patient with history of renal cancer and negative computed tomography scanning for pancreatic or other causes of obstruction should alert for prompt investigation for an ampullary metastasis. © 2013 Karakatsanis et al.; licensee BioMed Central Ltd

The effect of transversus abdominis plane block on acute and chronic pain after inguinal hernia repair. A randomized controlled trial

Background: This prospective double-blind randomized study aimed at evaluating the short- and long-term postoperative analgesic efficacy of the ultrasound-guided tranversus abdominis plane (TAP) block in inguinal hernia repair under general anesthesia. Methods: Sixty patients undergoing inguinal hernia repair were allocated to TAP block with either ropivacaine 0.75% 20 mL or placebo 20 mL. Postoperatively, they had access to a patient-controlled analgesia (PCA) device administering 1 mg doses of morphine as rescue analgesia. Pain was assessed at rest and during movement with the numeric rating scale (NRS) score 3,6 and 24 hs postoperatively. Other variables recorded were intraoperative dose of remifentanil required to maintain systolic arterial pressure within 20% of baseline, mg of morphine used in the Post Anesthesia Care Unit (PACU) and total dose of morphine administered via the PCA device. Six months after surgery, the occurrence of chronic pain was assessed with the NRS score at rest and during movement. Patients were also asked to fill in the DN4 questionnaire to estimate the development of neuropathic pain. Results: Patients who were administered ropivacaine demonstrated significantly less pain at rest and on movement, as expressed by NRS scores in comparison to patients in the placebo group. The former group also required less remifentanil intraoperatively, less morphine during the PACU stay and had lower morphine consumption through the PCA device. Six months after surgery, pain scores at rest and during movement were comparable between the two groups. At the same time DN4 scores were low and comparable between the two groups. Conclusion: Ultrasound-guided TAP block provided better pain control than placebo in the acute setting after inguinal hernia repair. However, the incidence of chronic pain was low and not significantly affected by the performance of the block. © 2019 IJS Publishing Group Lt