SurLym trial: study protocol for a multicentre pragmatic randomised controlled trial on the added value of reconstructive lymphatic surgery to decongestive lymphatic therapy for the treatment of lymphoedema.

INTRODUCTION: Lymphoedema is a chronic condition caused by lymphatic insufficiency. It leads to swelling of the limb/midline region and an increased risk of infection. Lymphoedema is often associated with mental and physical problems limiting quality of life. The first choice of treatment is a conservative treatment, consisting of exercises, skin care, lymph drainage and compression. Reconstructive lymphatic surgery is also often performed, that is, lymphovenous anastomoses, lymph node transfer or a combination. However, robust evidence on the effectiveness of reconstructive lymphatic surgery is missing. Therefore, the objective of this trial is to investigate the added value of reconstructive lymphatic surgery to the conservative treatment in patients with lymphoedema. METHODS AND ANALYSIS: A multicentre randomised controlled and pragmatic trial was started in March 2022 in three Belgian university hospitals. 90 patients with arm lymphoedema and 90 patients with leg lymphoedema will be included. All patients are randomised between conservative treatment alone (control group) or conservative treatment with reconstructive lymphatic surgery (intervention group). Assessments are performed at baseline and at 1, 3, 6, 12, 18, 24 and 36 months. The primary outcome is lymphoedema-specific quality of life at 18 months. Key secondary outcomes are limb volume and duration of wearing the compression garment at 18 months. The approach of reconstructive lymphatic surgery is based on presurgical investigations including clinical examination, lymphofluoroscopy, lymphoscintigraphy, lymph MRI or CT angiography (if needed). All patients receive conservative treatment during 36 months, which is applied by the patient's own physical therapist and by the patient self. From months 7 to 12, the hours a day of wearing the compression garment are gradually decreased. ETHICS AND DISSEMINATION: The study has been approved by the ethical committees of University Hospitals Leuven, Ghent University Hospital and CHU UCL Namur. Results will be disseminated via peer-reviewed journals and presentations. TRIAL REGISTRATION NUMBER: NCT05064176.

Diagnostic imaging in lipedema: A systematic review.

BACKGROUND: Diagnosing lipedema remains a challenge due to its heterogeneous presentation, co-existing diseases, and the lack of objective diagnostic imaging. OBJECTIVE: This systematic review aims to outline the currently available diagnostic imaging methods to characterize lipedema in the legs along with their diagnostic performance. METHODS: PubMed, Embase, Google Scholar, Scopus, and Web of Science were searched. The quality assessment of diagnostic accuracy studies (QUADAS) tool was used for quality assessment. RESULTS: Thirty-two studies describing a total of 1154 patients with lipedema were included for final analysis. Features for lipedema have been defined using ultrasound (increased subcutaneous adipose tissue), lymphoscintigraphy (slowing of the lymphatic flow and a frequent asymmetry between the lower extremities), computed tomography (symmetrical bilateral soft tissue enlargement without either skin thickening or subcutaneous edema), magnetic resonance imaging (increased subcutaneous adipose tissue), MR lymphangiography (enlarged lymphatic vessels up to a diameter of 2 mm), and dual-energy X-ray absorptiometry (fat mass in the legs adjusted for body mass index (BMI) ≥ 0.46 or fat mass in the legs adjusted for total fat mass ≥ 0.384). CONCLUSION: The diagnostic performance of currently available imaging modalities for assessing lipedema is limited. Prospective studies are needed to evaluate and compare the diagnostic performance of each imaging modality. Imaging techniques focusing on the pathogenesis of the disease are needed.

Extramedullary Hematopoiesis in Treated Diffuse Large B-Cell Lymphoma of Bone.

ABSTRACT: A 65-year-old man with a history of diffuse large B-cell bone lymphoma of the right radius underwent an interim FDG PET/CT after 2 cycles of chemotherapy. Besides a complete metabolic response on the primary site, images revealed a hypermetabolic nodule in the posterior mediastinum, not present on the initial images. The metabolic activity of the nodule was similar to that of the reactive bone marrow and disappeared, concomitantly to the normalization of the medullar signal on the posttreatment images. The similarity and synchronous metabolic activity evolution in the nodule and bone marrow indicate extramedullary hematopoiesis.

Complete Femoral Osteonecrosis in the Setting of Myelodysplastic Syndrome.

ABSTRACT: A 76-year-old man was diagnosed with a hematological neoplasm combining myelodysplastic and myeloproliferative characteristics back in July 2021. Five months after the diagnosis, his condition got more severe when the blasts rose up to 14%, so he was started on hypomethylating agent-based therapy. A few weeks later, the patient was hospitalized after developing fever and a pain in the right thigh. To exclude any source of occult infection, an 18 F-FDG PET/CT was performed. FDG PET/CT showed a complete lack of metabolism in the right femur. An MRI and a biopsy confirmed the suspected diagnosis of osteonecrosis.

Presacral Myelolipoma: The Usefulness of a 99mTc-Albumin Nanocolloid Scintigraphy.

Myelolipoma is a rare mesenchymal tumor consisting of adipose tissue and hematopoietic cells. Found usually in the adrenal region, however, few cases have been reported in extra-adrenal regions, most frequently in the presacral region. It is important to recognize such tumor, as it can attain massive size and causes pressure symptoms, and needs to be differentiated from malignant tumors, including liposarcomas. Although CT and MRI can suggest a diagnosis of myelolipoma, these are not conclusive. The hematopoietic cells are enhanced by a Tc-albumin nanocolloid scintigraphy and help to distinguish myolipoma from other entities.

Do computerized clinical decision support systems improve the prescribing of oral anticoagulants? A systematic review.

BACKGROUND: Serious adverse drug reactions have been associated with the underuse or the misuse of oral anticoagulant therapy. We systematically reviewed the impact of computerized clinical decision support systems (CDSS) on the prescribing of oral anticoagulants and we described CDSS features associated with success or failure. METHODS: We searched Medline, Embase, CENTRAL, CINHAL, and PsycINFO for studies that compared CDSS for the initiation or monitoring of oral anticoagulants with routine care. Two reviewers performed study selection, data collection, and risk-of-bias assessment. Disagreements were resolved with a third reviewer. Potentially important CDSS features, identified from previous literature, were evaluated. RESULTS: Sixteen studies were included in our qualitative synthesis. Most trials were performed in primary care (n = 7) or hospitals (n = 6) and included atrial fibrillation (AF) patients (n = 9). Recommendations mainly focused on anticoagulation underuse (n = 11) and warfarin-drug interactions (n = 5). Most CDSS were integrated in electronic records or prescribing and provided support automatically at the time and location of decision-making. Significant improvements in practitioner performance were found in 9 out of 16 studies, while clinical outcomes were poorly reported. CDSS features seemed slightly more common in studies that demonstrated improvement. CONCLUSIONS: CDSS might positively impact the use of oral anticoagulants in AF patients at high risk of stroke. The scope of CDSS should now evolve to assist prescribers in selecting the most appropriate and tailored medication. Efforts should nevertheless be made to improve the relevance of notifications and to address implementation outcomes.

Correction to: Development of a tool for benchmarking of clinical pharmacy activities.

In the original publication of an article, the corresponding author name has been swapped. Now the correct name has been published in this correction.

Development of a tool for benchmarking of clinical pharmacy activities.

Background Initiatives are needed to promote and evaluate clinical pharmacy. In this context, benchmarking could be useful. Objective To develop and validate a benchmarking tool for clinical pharmacy activities. Setting Six Belgian hospitals. Method A narrative literature review and two focus groups were performed to identify (1) clinical pharmacy benchmarking projects, (2) clinical pharmacy activities with a proven positive impact on the quality of care for patients, (3) quality indicators and (4) contextual factors to be included in the tool. Next, a Delphi survey and a test of the tool in practice led to content validation and usability of the benchmarking tool. Main Outcome Measure To identify quality indicators and contextual factors to be included in the tool. Results Three Delphi rounds were required (rounds 1-2: 9 participants, round 3: 8 participants). Ten quality indicators and 36 relevant contextual factors were selected. These 10 quality indicators represent 6 clinical pharmacy activities that demonstrated to improve patient outcomes: medication reconciliation at admission, patient monitoring, information provided to the health care team, patient education, discharge and transfer medication counselling, and adverse drug reaction monitoring. To collect the information needed to compose the quality indicators and to benchmark, the tool consists of three data collection instruments. An instruction manual accompanies the tool. Conclusion We have developed and validated a benchmarking tool, designed to identify and promote clinical pharmacy activities that demonstrated to improve patient outcomes. Future perspectives include the use of the tool on a national scale to identify the most efficient practices and their enablers and barriers.

Electronic tools to support medication reconciliation: a systematic review.

OBJECTIVES: Medication reconciliation (MedRec) is essential for reducing patient harm caused by medication discrepancies across care transitions. Electronic support has been described as a promising approach to moving MedRec forward. We systematically reviewed the evidence about electronic tools that support MedRec, by (a) identifying tools; (b) summarizing their characteristics with regard to context, tool, implementation, and evaluation; and (c) summarizing key messages for successful development and implementation. MATERIALS AND METHODS: We searched PubMed, the Cumulative Index to Nursing and Allied Health Literature, Embase, PsycINFO, and the Cochrane Library, and identified additional reports from reference lists, reviews, and patent databases. Reports were included if the electronic tool supported medication history taking and the identification and resolution of medication discrepancies. Two researchers independently selected studies, evaluated the quality of reporting, and extracted data. RESULTS: Eighteen reports relative to 11 tools were included. There were eight quality improvement projects, five observational effectiveness studies, three randomized controlled trials (RCTs) or RCT protocols (ie, descriptions of RCTs in progress), and two patents. All tools were developed in academic environments in North America. Most used electronic data from multiple sources and partially implemented functionalities considered to be important. Relevant information on functionalities and implementation features was frequently missing. Evaluations mainly focused on usability, adherence, and user satisfaction. One RCT evaluated the effect on potential adverse drug events. CONCLUSION: Successful implementation of electronic tools to support MedRec requires favorable context, properly designed tools, and attention to implementation features. Future research is needed to evaluate the effect of these tools on the quality and safety of healthcare.

Comprehensive cost analysis of sentinel node biopsy in solid head and neck tumors using a time-driven activity-based costing approach.

Head and neck cancer (HNC) is predominantly a locoregional disease. Sentinel lymph node (SLN) biopsy offers a minimally invasive means of accurately staging the neck. Value in healthcare is determined by both outcomes and the costs associated with achieving them. Time-driven activity-based costing (TDABC) may offer more precise estimates of the true cost. Process maps were developed for nuclear medicine, operating room and pathology care phases. TDABC estimates the costs by combining information about the process with the unit cost of each resource used. Resource utilization is based on observation of care and staff interviews. Unit costs are calculated as a capacity cost rate, measured as a Euros/min (2014), for each resource consumed. Multiplying together the unit costs and resource quantities and summing across all resources used will produce the average cost for each phase of care. Three time equations with six different scenarios were modeled based on the type of camera, the number of SLN and the type of staining used. Total times for different SLN scenarios vary between 284 and 307 min, respectively, with a total cost between 2794 and 3541€. The unit costs vary between 788€/h for the intraoperative evaluation with a gamma-probe and 889€/h for a preoperative imaging with a SPECT/CT. The unit costs for the lymphadenectomy and the pathological examination are, respectively, 560 and 713€/h. A 10 % increase of time per individual activity generates only 1 % change in the total cost. TDABC evaluates the cost of SLN in HNC. The total costs across all phases which varied between 2761 and 3744€ per standard case.

Cost comparison of open approach, transoral laser microsurgery and transoral robotic surgery for partial and total laryngectomies.

Activity-based costing is used to give a better insight into the actual cost structure of open, transoral laser microsurgery (TLM) and transoral robotic surgery (TORS) supraglottic and total laryngectomies. Cost data were obtained from hospital administration, personnel and vendor structured interviews. A process map identified 17 activities, to which the detailed cost data are related. One-way sensitivity analyses on the patient throughput, the cost of the equipment or operative times were performed. The total cost for supraglottic open (135-203 min), TLM (110-210 min) and TORS (35-130 min) approaches were 3,349 euro (3,193-3,499 euro), 3,461 euro (3,207-3,664 euro) and 5,650 euro (4,297-5,974 euro), respectively. For total laryngectomy, the overall cost were 3,581 euro (3,215-3,846 euro) for open and 6,767 euro (6,418-7,389 euro) for TORS. TORS cost is mostly influenced by equipment (54%) where the other procedures are predominantly determined by personnel cost (about 45%). Even when we doubled the yearly case-load, used the shortest operative times or a calculation without robot equipment costs we did not reach cost equivalence. TORS is more expensive than standard approaches and mainly influenced by purchase and maintenance costs and the use of proprietary instruments. Further trials on long-term outcomes and costs following TORS are needed to evaluate its cost-effectiveness.

A systematic review of the predictive value of (18)FDG-PET in esophageal and esophagogastric junction cancer after neoadjuvant chemoradiation on the survival outcome stratification.

PURPOSE: We studied the predictive value of [(18) F]fluorodeoxyglucose-positron emission tomography ((18)FDG-PET) for assessing disease-free (DFS) and overall survival (OS) in esophageal and esophagogastric junction cancer. MATERIALS AND METHODS: A literature search (PUBMED/MEDLINE, EMBASE, Cochrane) was performed to identify full papers with (18)FDG-PET and survival data, using indexing terms and free text words. Studies with >10 patients with locally advanced esophageal cancer, presenting sequential or at least one post-adjuvant treatment (18)FDG-PET data and Kaplan-Meier survival curves with >6 months median follow-up period were included. We performed a meta-analysis for DFS and OS using the hazard ratio (HRs) as outcome measure. Sources of heterogeneity study were also explored. RESULTS: We identified 26 eligible studies including a total of 1,544 patients (average age 62 years, 82% males). The TNM distribution was as follows: stage I 7%, II 24%, III 53% and IV 15%. The pooled HRs for complete metabolic response versus no response were 0.51 for OS (95% CI, 0.4-0.64; P < 0.00001) and 0.47 for DFS (95% CI, 0.38-0.57; P < 0.00001), respectively. No statistical heterogeneity was present. To explore sources of clinical heterogeneity, we also realised subgroup and regression analyses. Taken into account the moderate correlation between OS and DFS (ρ = 0.54), we used joint bivariate random regression model. These analyses did not show a statistically significant impact of study characteristics and PET modalities on the pooled outcome estimates. CONCLUSION: Despite methodological and clinical heterogeneity, metabolic response on (18)FDG-PET is a significant predictor of long-term survival data.

Performance of the adverse drug event trigger tool and the global trigger tool for identifying adverse drug events: experience in a Belgian hospital.

BACKGROUND: Medication-related harm can be detected using the adverse drug event (ADE) trigger tool and the medication module of the Global Trigger Tool (GTT) developed by the Institute for Healthcare Improvement (IHI). In recent years, there has been some controversy on the performance of this method. In addition, there are limited data on the performance of the medication module of the GTT as compared with the ADE trigger tool. OBJECTIVES: To evaluate the performance of the ADE trigger tool and of the medication module of the GTT for identifying ADEs. METHODS: The methodology of the IHI was used. A random sample of 20 adult admissions per month was selected over a 12-month period in a teaching hospital in Belgium. The ADE trigger tool was adapted to the Belgian setting and included 20 triggers. The positive predictive value (PPV) of each trigger was calculated, as well as the proportion of ADEs that would have been identified with the medication module of the GTT as compared with the ADE trigger tool. RESULTS: A total of 200 triggers and 62 ADEs were found, representing 26 ADEs/100 admissions. Nineteen ADEs (31%) were found spontaneously without the presence of a trigger. Three triggers never occurred. The PPVs of other triggers varied from 0 to 0.67, with half of them having PPVs less than 0.20. If we had used the medication triggers included in the GTT (n = 11), we would have identified 77% of total ADEs and 67% of preventable ADEs. CONCLUSIONS: Applying the trigger tool method proposed by the IHI to a Belgian hospital led to the identification of one ADE out of 4 admissions. To increase performance, refining the list of triggers in the ADE trigger tool and in the medication module of the GTT would be needed. Recording nontriggered events should be encouraged.

An atypical relapse of acute myeloid leukemia diagnosed by 18F-FDG PET/CT.

Extramedullary relapse of acute myeloid leukemia (AML) after stem-cell transplant is very rare and often remains a diagnostic challenge. Although the diagnostic value of PET/CT has not been evaluated thoroughly in leukemia, it might be useful for detecting these focal localizations. We presented a case of a 58-year-old man, with a prior history of localized bladder cancer and a secondary AML, referred to our hospital with important thoracic backaches. PET/CT revealed the presence of meningeal carcinomatosis at the thoracic level, as well as lymph nodes, and muscular and bone metastases. Immunophenotyping of the cerebrospinal fluid aspirate showed a relapse of AML.

Reliability of sentinel node technique in the treatment of N0 supraglottic laryngeal cancer.

OBJECTIVE: To study the reliability of the sentinel node technique (SNT) in the management of the N0 neck in patients with supraglottic laryngeal cancer. METHODS: Patients presenting to our department, between 2001 and 2004, with T1-T3 supraglottic cancer and N0 neck, clinically and radiologically, were included in the study. All patients underwent sentinel lymph node detection, using the hand-held gamma probe followed by bilateral modified radical neck dissection (MRND) and resection of the primary tumor. We compared the results of the SNT with those of the gold standard MRND for the staging of the neck. The histologic examination was performed after fixation for both the products of SNT and MRND. RESULTS: Twenty-nine patients were included in the study. Twenty-one had T2, 2 had T1, and 6 had T3 tumors. Patients had transoral CO(2) laser-assisted resection of the primary tumor. All the patients underwent bilateral neck dissection immediately after the sentinel node biopsy. Of the 95 sentinel lymph nodes harvested, 22 were positive for lymph node metastasis. The mean number of sentinel node per patient was 3. Of the 58 modified neck dissections (2 neck sides/patient), there was 1 additional positive lymph node, in the prelaryngeal area, and the patient had already positive sentinel lymph nodes. The SNT allowed the identification of node metastasis in 100% of the cases with a sensitivity of 100 (48-100), specificity of 78 (64-88), negative predictive value of 100 (91-100). CONCLUSIONS: SNT is reliable in the staging of the clinically N0 neck in patients with supraglottic cancer.

Cost-effectiveness analysis of FDG PET-CT in the management of pulmonary metastases from malignant melanoma.

OBJECTIVES: Most guidelines consider FDG PET-CT to detect occult extra-pulmonary disease prior to lung metastasectomy. A cost-effectiveness analysis, using a Markov model over a 10 year period, was performed to compare two different surveillance programs, either PET-CT or whole-body CT, in patients with suspected pulmonary metastasised melanoma. METHODS: Data from published studies provided probabilities for the model. Complication and care costs were obtained from standardised administrative databases from 19 hospitals identified by DRG codes (reported in 2009 Euros). For the cost calculation of PET-CT we performed a microcosting analysis. All costs and benefits were yearly discounted at respectively 3% and 1.5%. Outcomes included life-months gained (LMG) and the number of futile surgeries avoided. Cost-effectiveness ratios were in Euros per LMG. Univariate and probabilistic sensitivity analyses addressed uncertainty in all model parameters. RESULTS: The PET-CT strategy provided 86.29 LMG (95% CI: 81.50-90.88 LMG) at a discounted cost of euro3,974 (95% CI: euro1,339-12,303), while the conventional strategy provided 86.08 LMG (95% CI: 81.37-90.68 LMG) at a discounted cost of euro5,022 (95% CI: euro1,378-16,018). This PET-CT strategy resulted in a net saving of euro1,048 with a gain of 0.2 LMG. Based on PET-CT findings, 20% of futile surgeries could be avoided. CONCLUSION: Integrating PET-CT in the management of patients with high risk MM appears to be less costly and more accurate by avoiding futile thoracotomies in one of five patients as well as by providing a small survival benefit at 10 years.

Activity-based costing evaluation of a [(18)F]-fludeoxyglucose positron emission tomography study.

OBJECTIVE: The aim of the study is to use the activity-based costing approach to give a better insight in the actual cost structure of a positron emission tomography procedure (FDG-PET) by defining the constituting components and by simulating the impact of possible resource or practice changes. METHODS: The cost data were obtained from the hospital administration, personnel and vendor interviews as well as from structured questionnaires. A process map separates the process in 16 patient- and non-patient-related activities, to which the detailed cost data are related. One-way sensitivity analyses shows to which degree of uncertainty the different parameters affect the individual cost and evaluate the impact of possible resource or practice changes like the acquisition of a hybrid PET/CT device, the patient throughput or the sales price of a 370MBq (18)F-FDG patient dose. RESULTS: The PET centre spends 73% of time in clinical activities and the resting time after injection of the tracer (42%) is the single largest departmental cost element. The tracer cost and the operational time have the most influence on cost per procedure. The analysis shows a total cost per FDG-PET ranging from 859 Euro for a BGO PET camera to 1142 Euro for a 16 slices PET-CT system, with a distribution of the resource costs in decreasing order: materials (44%), equipment (24%), wage (16%), space (6%) and hospital overhead (10%). CONCLUSIONS: The cost of FDG-PET is mainly influenced by the cost of the radiopharmaceutical. Therefore, the latter rather than the operational time should be reduced in order to improve its cost-effectiveness.

Role of PET in the initial staging of cutaneous malignant melanoma: systematic review.

PURPOSE: To calculate summary estimates of the diagnostic performance of fluorine 18 fluorodeoxyglucose (FDG) positron emission tomographic (PET) imaging in the initial staging of cutaneous malignant melanoma (CMM), following the new American Joint Committee on Cancer (AJCC) staging classification on per-patient and per-lesion bases. MATERIALS AND METHODS: MEDLINE, EMBASE, Web of Science, and Cochrane Database of Systematic Reviews databases, and reference lists of reviews and included papers were searched, without any language restrictions, for relevant articles published before March 2007. Two reviewers independently assessed study eligibility and methodologic quality by using the quality assessment of diagnostic accuracy studies checklist. A pooled random effect was estimated and a fixed coefficient regression model was used to explore the existing heterogeneity. RESULTS: Twenty-eight studies involving 2905 patients met the inclusion criteria. The pooled estimates of FDG PET for the detection of metastasis in the initial staging of CMM were sensitivity, 83% (95% confidence interval [CI]: 81%, 84%); specificity, 85% (95% CI: 83%, 87%); positive likelihood ratio (LR), 4.56 (95% CI: 3.12, 6.64); negative LR, 0.27 (95% CI: 0.18, 0.40); and diagnostic odds ratio, 19.8 (95% CI: 10.8, 36.4). Results from eight studies suggested that FDG PET was associated with 33% disease management changes (range, 15%-64%). CONCLUSION: There is good preliminary evidence that FDG PET is useful for the initial staging of patients with CMM, especially as adjunctive role in AJCC stages III and IV, to help detect deep soft-tissue, lymph node, and visceral metastases. FDG PET-computed tomographic imaging seemed to be more precise than PET alone, as suggested by four eligible studies. Further evaluation by using a well-designed prospective study, with clinical outcome-focused measures and cost effectiveness analysis, is needed to clarify the appropriate role of FDG PET in CMM staging. SUPPLEMENTAL MATERIAL: http://radiology.rsnajnls.org/cgi/content/full/249/3/836/DC1.