The usage of population and disease registries as pre-screening tools for clinical trials, a systematic review.

OBJECTIVE: This systematic review aims to outline the use of population and disease registries for clinical trial pre-screening. MATERIALS AND METHODS: The search was conducted in the time period of January 2014 to December 2022 in three databases: MEDLINE, Embase, and Web of Science Core Collection. References were screened using the Rayyan software, firstly based on titles and abstracts only, and secondly through full text review. Quality of the included studies was assessed using the List of Included Studies and quality Assurance in Review tool, enabling inclusion of publications of only moderate to high quality. RESULTS: The search originally identified 1430 citations, but only 24 studies were included, reporting the use of population and/or disease registries for trial pre-screening. Nine disease domains were represented, with 54% of studies using registries based in the USA, and 62.5% of the studies using national registries. Half of the studies reported usage for drug trials, and over 478,679 patients were identified through registries in this review. Main advantages of the pre-screening methodology were reduced financial burden and time reduction. DISCUSSION AND CONCLUSION: The use of registries for trial pre-screening increases reproducibility of the pre-screening process across trials and sites, allowing for implementation and improvement of a quality assurance process. Pre-screening strategies seem under-reported, and we encourage more trials to use and describe their pre-screening processes, as there is a need for standardized methodological guidelines.

Building resilience: analysis of health care leaders' perspectives on the Covid-19 response in Region Stockholm.

BACKGROUND: The Covid-19 pandemic has tested health care organizations worldwide. Responses have demonstrated great variation and Sweden has been an outlier in terms of both strategy and how it was enacted, making it an interesting case for further study. The aim of this study was to explore how health care leaders experienced the challenges and responses that emerged during the initial wave of the Covid-19 pandemic, and to analyze these experiences through an organizational resilience lens. METHODS: A qualitative interview study with 12 senior staff members who worked directly with or supervised pandemic efforts. Transcripts were analyzed using traditional content analysis and the codes directed to the Integrated Resilience Attributes Framework to understand what contributed to or hindered organizational resilience, i.e. how organizations achieve their goals by utilizing existing resources during crises. RESULTS/FINDINGS: Organizational resilience was found at the micro (situated) and meso (structural) system levels as individuals and organizations dealt with acute shortages and were forced to rapidly adapt through individual sacrifices, resource management, process management, and communications and relational capacity. Poor systemic resilience related to misaligned responses and a lack of learning from previous experiences, negatively impacted the anticipatory phase and placed greater pressure on individuals and organizations to respond. Conventional crisis leadership could hamper innovation, further cement chronic challenges, and generate a moral tension between centralized directives and clinical microsystem experiences. CONCLUSIONS: The pandemic tested the resilience of the health care system, placing undue pressure on micro and meso systems responses. With improved learning capabilities, some of this pressure may be mitigated as it could raise the anticipatory resilience potential, i.e. with better health systems learning, we may need fewer heroes. How crisis leadership could better align decision-making with frontline needs and temper short-term acute needs with a longer-term infinite mindset is worth further study.

Skin microvascular reactivity correlates to clinical microangiopathy in type 1 diabetes: A pilot study.

AIM: The aim of this study was to investigate the correlation between skin microvascular reactivity and clinical microangiopathy in patients with type 1 diabetes. METHODS: We included 61 patients with type 1 diabetes, that is, 31 patients with and 30 without clinical microangiopathy, and 31 healthy controls. A microangiopathy scoring system was introduced for comparison of data between patients with microangiopathy. Responses to iontophoresis of acetylcholine and sodium nitroprusside were assessed by laser Doppler imaging. RESULTS: Patients with microangiopathy had reduced acetylcholine- and sodium nitroprusside-mediated flux in forearm skin microcirculation compared to healthy controls (p = 0.03 and p < 0.001, respectively, repeated measures analysis of variance), whereas no significant differences were found between patients without microangiopathy and controls. Skin reactivity was reduced in patients with microangiopathy compared to patients without microangiopathy: 1.43 ± 0.38 versus 1.59 ± 0.39 arbitrary units for acetylcholine-mediated peak flux and 1.44 ± 0.46 versus 1.74 ± 0.34 arbitrary units for sodium nitroprusside-mediated peak flux (p < 0.05 for both). A tendency of gradual decrease in acetylcholine and sodium nitroprusside responses was found in patients with increasing microangiopathy scores. CONCLUSION: We conclude that skin microvascular reactivity is associated with clinical microangiopathy in patients with type 1 diabetes. Impaired skin microvascular function in type 1 diabetes seems to be multifactorial and involves both endothelial-dependent and endothelial-independent pathways. We introduce a novel microangiopathy score that could easily be used in a clinical setting for comparison of patients with various degrees of microangiopathy.

Non-contrast 3D MR lymphography of retroperitoneal lymphatic aneurysmal dilatation: a continuous spectrum of change from normal variants to cystic lymphangioma.

OBJECTIVE: Our objective was to demonstrate the characteristic features of retroperitoneal lymphatic aneurysmal dilatation with three-dimensional (3D) magnetic resonance (MR) lymphography. CONCLUSION: Three-dimensional MR lymphography demonstrates that retroperitoneal lymphatic aneurysmal dilatation exhibits a continuous spectrum of change from normal variants to lymphatic aneurysmal dilatation and so-called cystic lymphangioma. MAIN MESSAGE: • Non-contrast MR lymphography with very heavily T2-weighted fast spin echo sequences is a useful non-invasive technique without the need of contrast medium injection to obtain a unique evaluation of the lymphatic system • To prove the lymphatic origin of a cystic formation, it is essential to demonstrate the communication with retroperitoneal lymphatic vessels • 3D MR lymphography demonstrates that retroperitoneal lymphatic aneurysmal dilatation exhibits a continuous spectrum of change from normal variants to lymphatic aneurysmal dilatation and so-called cystic lymphangioma.

MR imaging features of nongynaecologic cystic lesions of the pelvis.

OBJECTIVE: The purpose of our article is to review the magnetic resonance imaging (MRI) features of nongynaecologic cystic lesions of the pelvis. CONCLUSION: The rising use of MRI for pelvic exploration will result in an increase in incidental detection of pelvic cystic cysts. Pelvic cysts of non gynecologic origin are less frequent than gynecologic cysts. However, they account for a wide range of abnormalities, and radiologists must be aware of their features and characteristics.

Relapse of Crohn's disease following ileal pouch-anal anastomosis: MDCT and MR features.

OBJECTIVE: The purpose of our study is to use MDCT and MR imaging to describe the normal ileal pouch and to identify features of Crohn's disease (CD) relapse in patients after ileal pouch-anal anastomosis (IPAA). CONCLUSIONS: After total colectomy followed by IPAA, features, optimally evaluated with pelvic MRI, such as fistulas, abscesses, pouch inflammation, and stenoses, indicate CD relapse. Although uncommon, radiologists should be aware that these imaging features strongly favor this diagnosis.

CT and MRI features of ileostomies.

OBJECTIVE: The purpose of this article is to describe CT and MRI features of normal anatomy, variants, and pathologic conditions of different ileostomies. CONCLUSION: Multiplanar imaging techniques are useful to identify the complications related to stoma construction and preexisting disease. Understanding the indications for ileostomy construction, surgical techniques, and postoperative anatomy is important for differentiating normal and abnormal imaging features.

"Habit" gambling behaviour caused by ischemic lesions affecting the cognitive territories of the basal ganglia.

We report the case of a patient suffering from sudden apathy and pathological gambling-like behaviour after bilateral ischemic lesions involving the dorsal portion of the head of the caudate nuclei and adjacent anterior limb of the internal capsules. This is the first report of the association of an apathy and abnormal gambling behaviour following a stroke affecting sub-cortical structures. Although the location of the lesions, affecting the dorsal striatum, may explain the emergence of an apathetic state, it is, however, at first sight, not easy to explain the gambling behaviour because the patient was normal in tests evaluating sensitivity to reward, and no radiological abnormality was found in the cortical-sub-cortical system of reward. It is proposed that, for this patient, the mechanism of maladaptive gambling behaviour was the development of a routine behaviour related to the patient's cognitive inertia, a mechanism different from the changes in reward sensitivity observed after damage to the orbital ventral prefrontal-ventral striatum system or in dopamine dysregulation syndrome in Parkinson's disease.

Computed tomography features of acute thrombosis of central veins with perivenous inflammatory changes.

OBJECTIVE: Our purpose was to examine the computed tomographic findings in 13 patients with acute deep venous thrombosis (DVT) of central veins of the neck, chest, and abdomen in whom major perivenous inflammatory changes were noted. METHODS: During a 10-year period, 13 patients with acute DVT of 21 central veins and marked perivenous inflammatory changes on computed tomography were identified. Computed tomography images were assessed for location of DVT and pattern of perivenous changes. RESULTS: The perivenous changes took the form of a rounded or lobulated perivenous bulky mass (massive pattern or tumorlike) in 5 patients and of infiltrative changes in the other 8 patients. Direct visualization of the thrombotic vein was possible in 8 patients. Follow-up examinations (range, 6-36 months; mean, 15 months) demonstrated resolution of perivenous inflammatory changes with anticoagulation therapy in all cases. CONCLUSION: Perivenous inflammatory changes around the thrombotic vein presented as a rounded or lobulated perivenous bulky mass that may mimic a tumor or as infiltrative perivenous changes.

Continuous preperitoneal infusion of ropivacaine provides effective analgesia and accelerates recovery after colorectal surgery: a randomized, double-blind, placebo-controlled study.

BACKGROUND: Blockade of parietal nociceptive afferents by the use of continuous wound infiltration with local anesthetics may be beneficial in a multimodal approach to postoperative pain management after major surgery. The role of continuous preperitoneal infusion of ropivacaine for pain relief and postoperative recovery after open colorectal resections was evaluated in a randomized, double-blinded, placebo-controlled trial. METHODS: After obtaining written informed consents, a multiholed wound catheter was placed by the surgeon in the preperitoneal space at the end of surgery in patients scheduled to undergo elective open colorectal resection by midline incision. They were thereafter randomly assigned to receive through the catheter either 0.2% ropivacaine (10-ml bolus followed by an infusion of 10 ml/h during 48 h) or the same protocol with 0.9% NaCl. In addition, all patients received patient-controlled intravenous morphine analgesia. RESULTS: Twenty-one patients were evaluated in each group. Compared with preperitoneal saline, ropivacaine infusion reduced morphine consumption during the first 72 h and improved pain relief at rest during 12 h and while coughing during 48 h. Sleep quality was also better during the first two postoperative nights. Time to recovery of bowel function (74 +/- 19 vs. 105 +/- 54 h; P = 0.02) and duration of hospital stay (115 +/- 25 vs. 147 +/- 53 h; P = 0.02) were significantly reduced in the ropivacaine group. Ropivacaine plasma concentrations remained below the level of toxicity. No side effects were observed. CONCLUSIONS: Continuous preperitoneal administration of 0.2% ropivacaine at 10 ml/h during 48 h after open colorectal resection reduced morphine consumption, improved pain relief, and accelerated postoperative recovery.

Magnetic resonance imaging of the ischiorectal fossa: spectrum of disease.

OBJECTIVE: Pelvic magnetic resonance imaging (MRI) studies are widely used to assess the rectum, anal canal, and their environment. The purpose of this article is to review the current role of MRI in the evaluation of diseases involving the ischiorectal fossa and their imaging features. CONCLUSIONS: The radiologist plays an essential role in the evaluation of some conditions typically located in this space and of other conditions that occasionally involve this area or invade the ischioanal space. The accurate assessment of these diseases that MRI provides further cements its role as the primary technique for the evaluation of pelvic pathology.

Normal and pathologic features of the postoperative biliary tract at 3D MR cholangiopancreatography and MR imaging.

Magnetic resonance (MR) imaging with cholangiopancreatographic sequences plays a critical role in evaluating alterations in the biliary tract after surgical procedures such as cholecystectomy, liver transplantation, hepatic resection, and the creation of a biliary-enteric anastomosis. MR cholangiopancreatography, a rapid, noninvasive, and accurate imaging technique for the assessment of early and late complications of hepatobiliary surgery, usually enables the identification of normal and abnormal postoperative changes. In cases of complete obstruction of the bile duct, MR cholangiopancreatography allows analysis of the biliary tract above and below the level of the obstruction, a capability essential for treatment planning and one that is not provided by either endoscopic retrograde cholangiopancreatography or percutaneous transhepatic cholangiography. MR cholangiopancreatography is particularly useful for the evaluation of biliary-enteric anastomoses, for which an endoscopic approach is generally precluded. It also can help detect and localize bile duct strictures and stones and can help accurately classify bile duct injuries. It is useful for detecting bile leaks, although it generally does not directly depict the extravasation of bile. In addition to MR cholangiopancreatography, T1- and T2-weighted MR imaging may be performed to depict extrabiliary soft-tissue structures and abnormalities such as an abscess, tumor recurrence or metastasis, hematoma, or hemobilia. Mangafodipir trisodium-enhanced MR cholangiopancreatography, a recently developed technique that provides a combination of anatomic and functional information, is particularly helpful for documenting bile leaks because it allows a functional evaluation of biliary excretion and may directly depict bile leakage from injured ducts.

Pouchography, CT, and MRI features of ileal J pouch-anal anastomosis.

OBJECTIVE: Our objective is to describe pouchography, CT, and MRI features of the J-shaped pouch, both normal and with pouch-related complications. CONCLUSION: Pouchography is performed before closure of the loop ileostomy to assess the integrity of the ileal pouch and anastomosis. CT and MRI can be performed when postoperative complications, such as small-bowel obstruction, pouchitis, leakage, abscess, intramural hematoma, desmoid tumor, or recurrent Crohn's disease, are suspected.

Multi-detector row CT: spectrum of diseases involving the ileocecal area.

The ileocecal area is a relatively short segment of the gastrointestinal tract but may be affected by pathologic conditions that are either common throughout the gastrointestinal system or exclusive to this area. These conditions include benign and malignant tumors, inflammatory processes (appendicitis, diverticulitis, epiploic appendagitis, Crohn disease), infectious diseases, and miscellaneous conditions (cecal ischemia, typhlitis, cecal volvulus, duplication cyst). The various components of the ileocecal area (cecum, appendix, ileocecal valve, terminal ileum) are close to one another, so that these conditions may involve more than one anatomic structure, thereby creating a diagnostic dilemma. The evaluation of various parameters (eg, stratified enhancement pattern of the thickened bowel wall, degree of thickening, extent and location of bowel wall involvement, degree of fat stranding relative to the degree of wall thickening) and associated findings (lymph nodes, mesenteric stranding, abscess and sinus tracts, fatty proliferation, solid organ abnormalities) will help narrow the differential diagnosis. Multi-detector row computed tomography (CT) is considered the best imaging examination for the evaluation of the ileocecal area. Consequently, the radiologist should be familiar with the multi-detector row CT features of the spectrum of diseases affecting this area to help ensure correct diagnosis and appropriate treatment.

Anatomic and pathologic findings at external phased-array pelvic MR imaging after surgery for anorectal disease.

Pelvic magnetic resonance (MR) imaging is useful for identification of postoperative changes, complications, and disease recurrence in patients who have undergone surgery for primary or recurrent anorectal disease. Commonly used interventions include treatment for anorectal carcinoma: anterior rectal resection with or without creation of different colic anastomoses and abdominoperineal excision with or without pelvic reconstruction (omentoplasty, placement of myocutaneous flaps). Other common interventions include treatment for inflammatory bowel disease (coloproctectomy with or without creation of an ileoanal anastomosis and ileal pouch) and treatment for fistulas (placement of flaps or setons). Postoperative anatomic changes and formation of scar tissue can usually be identified with consecutive MR imaging examinations. Pelvic MR imaging is an accurate technique for assessment of complications including anastomotic leakage, septic complications such as fistulas and abscesses, neoplastic recurrence, and other less common complications (perineal hernia, peritoneal pseudocyst). The sophisticated surgical procedures used in rectal surgery can alter normal anatomy and make image interpretation difficult. Thus, familiarity with the appearances of postoperative anatomic changes, complications, and tumor recurrence is essential for accurate MR imaging evaluation after surgery for anorectal disease.

MRI of rectal disorders.

OBJECTIVE: The objective of this pictorial essay is to provide a review of the diseases involving the rectal wall with an emphasis on the key clinical and radiologic differentiating features. CONCLUSION: A wide spectrum of disease processes can involve the rectum in adults. MRI is the technique of choice in the definitive diagnosis of these disease conditions, mainly because of its superior tissue contrast differentiation.

'Indolent' Waldenstrom's macroglobulinemia and a cerebrospinal fluid protein level of 16 g/L.

Waldenstrom's macroglobulinemia occasionally presents with neurological manifestations. Very rarely, it is due to a central nervous system localization, the so-called Bing Neel Syndrome. We report a patient with an 'indolent' systemic disease and surprisingly a concomitant major CNS involvement.

A new technique for localization of hepatic tumors that are poorly visible with CT fluoroscopy.

The purpose of this study was to report a new technique for localization of hepatic tumors that are poorly visible with CT fluoroscopy. Forty-three hepatocellular carcinomas were not visible with CT fluoroscopy. A 22-gauge Chiba end-hole needle was inserted in the approximate location of a lesion estimated on the basis of anatomical landmarks demonstrated on both previous MR and CT images. We injected 3 ml of a mixture of nonionic contrast material and saline solution. Following the first injection, contrast solution filled the hepatic lesion in 29 of 43 cases. In 8 of 43 cases, contrast solution was distributed in the normal surrounding liver. In 7 of these 8 cases, repositioning allowed us to adjust the needle in the tumor. In the other 6 of 43 cases, contrast solution spread within capsule or pseudocapsule (pattern 3). In all 6 cases, repositioning allowed to adjust the needle in the tumor. This new technique allows an accurate localization of hepatic tumors that are poorly visible with CT fluoroscopy.