Group Coping Intervention in Patients With Chronic Graft-Versus-Host Disease: A Pilot Randomized Clinical Trial.

BACKGROUND: More than half the long-term survivors of allogeneic hematopoietic cell transplantation develop chronic graft-versus-host disease (GVHD), a debilitating inflammatory syndrome. Supportive interventions to assist survivors in coping with chronic GVHD are critically needed. PATIENTS AND METHODS: We conducted a pilot randomized clinical trial of a multidisciplinary group intervention (Horizons Program; n=39) versus minimally enhanced usual care (n=41) for patients with moderate or severe chronic GVHD. Horizons participants received 8 weekly sessions about GVHD and coping co-led by a transplant clinician and a behavioral health expert via a secure videoconferencing platform. Participants completed the following surveys before randomization, at 10 weeks, and at 18 weeks: Functional Assessment of Cancer Therapy-Bone Marrow Transplant Scale (FACT-BMT) for quality of life (QoL), Lee Symptom Scale for symptom burden, and Hospital Anxiety and Depression Scale-Depression Symptoms (HADS) for mood. The primary endpoint was feasibility (≥50% enrollment, ≥80% attendance in half the sessions for the Horizons arm only, and ≥80% retention). We also explored preliminary efficacy of the Horizons intervention on changes in patient-reported outcomes with linear mixed effects models and estimates of effect size at 10 weeks. RESULTS: We enrolled and registered 80 (67.2%) of 119 eligible patients (mean age, 62 years; 48.8% female). Of the participants in the Horizons Program, 84.6% attended at least half the sessions. Of registered participants, 91.3% completed assessment follow-ups (Horizons, 35/39 [89.7%]; minimally enhanced usual care, 38/41 [92.7%]). Horizons participants reported improvements in QoL (b = 2.24; d=0.53), anxiety symptoms (b = -0.10; d=0.34), and depression symptoms (b = -0.71; d=0.44) compared with participants who received minimally enhanced usual care. CONCLUSIONS: Participation in a multidisciplinary group intervention study was feasible for patients with chronic GVHD, with promising signals for improving QoL and mood. A full-scale efficacy trial is needed to confirm effects on patient-reported outcomes.

Percutaneous insertion of long-covered biliary stents in patients with malignant duodenobiliary stricture.

OBJECTIVE: To investigate the technical feasibility, safety, and efficacy of a long-covered biliary stent in patients with malignant duodenobiliary stricture. METHODS: This retrospective study enrolled 57 consecutive patients (34 men, 23 women; mean age, 64 years; range, 32-85 years) who presented with malignant duodenobiliary stricture between February 2019 and November 2020. All patients were treated with a long (18 or 23 cm)-covered biliary stent. RESULTS: The biliary stent deployment was technically successful in all 57 patients. The overall adverse event rate was 17.5% (10 of 57 patients). Successful internal drainage was achieved in 55 (96.5%) of 57 patients. The median patient survival and stent patency times were 99 days (95% confidence interval [CI], 58-140 days) and 73 days (95% CI, 60-86 days), respectively. Fourteen (25.5%) of the fifty-five patients presented with biliary stent dysfunction due to sludge (n = 11), tumor overgrowth (n = 1), collapse of the long biliary stent by a subsequently inserted additional duodenal stent (n = 1), or rapidly progressed duodenal cancer (n = 1). A univariate Cox proportional hazards model did not reveal any independent predictor of biliary stent patency. CONCLUSIONS: Percutaneous insertion of a subsequent biliary stent was technically feasible after duodenal stent insertion. Percutaneous insertion of a long-covered biliary stent was safe and effective in patients with malignant duodenobiliary stricture. CLINICAL RELEVANCE STATEMENT: In patients with malignant duodenobiliary stricture, percutaneous insertion of a long-covered biliary stent was safe and effective regardless of duodenal stent placement. KEY POINTS: • Percutaneous insertion of long-covered biliary stents in patients with malignant duodenobiliary stricture is a safe and effective procedure. • Biliary stent deployment was technically successful in all 57 patients and successful internal drainage was achieved in 55 (96.5%) of 57 patients. • The median patient survival and stent patency times were 99 days and 73 days, respectively, after placement of a long-covered biliary stent in patients with duodenobiliary stricture.

Feasibility and diagnostic accuracy of fast whole-body MRI in slightly to moderately injured trauma patients.

OBJECTIVES: To determine the feasibility and diagnostic accuracy of fast whole-body magnetic resonance imaging (WB-MRI) compared to whole-body computed tomography (WB-CT) in detecting injuries of slightly to moderately injured trauma patients. MATERIALS AND METHODS: In a prospective single-center approach, trauma patients from convenience sampling with an expected Abbreviated Injury Scale (AIS) score ≤ 3 at admission, received an indicated contrast-enhanced WB-CT (reference standard) and a plain WB-MRI (index test) voluntarily up to five days after trauma. Two radiologists, blinded to the WB-CT findings, evaluated the absence or presence of injuries with WB-MRI in four body regions: head, torso, axial skeleton, and upper extremity. Diagnostic accuracy was determined using sensitivity, specificity, positive predictive value, and negative predictive value by body region. RESULTS: Between June 2019 and July 2021, 40 patients were assessed for eligibility of whom 35 (median age (interquartile range): 50 (32.5) years; 26 men) received WB-MRI. Of 140 body regions (35 patients × 4 regions), 31 true positive, 6 false positive, 94 true negative, and 9 false negative findings were documented with WB-MRI. Thus, plain WB-MRI achieved a total sensitivity of 77.5% (95%-confidence interval (CI): (61.6-89.2%)), specificity of 94% (95%-CI: (87.4-97.8%)), and diagnostic accuracy of 89.3% (95%-CI: (82.9-93.9%)). Across the four regions sensitivity and specificity varied: head (66.7%/93.1%), torso (62.5%/96.3%), axial skeleton (91.3%/75%), upper extremity (33.3%/100%). Both radiologists showed substantial agreement on the WB-MRI reading (Cohen's Kappa: 0.66, 95%-CI: (0.51-0.81)). CONCLUSION: Regarding injury detection, WB-MRI is feasible in slightly to moderately injured trauma patients, especially in the axial skeleton. CLINICAL RELEVANCE STATEMENT: Besides offering a radiation-free approach, whole-body MRI detects injuries almost identically to whole-body CT in slightly to moderately injured trauma patients, who comprise a relevant share of all trauma patients. KEY POINTS: Whole-body MRI could offer radiation-free injury detection in slightly to moderately injured trauma patients. Whole-body MRI detected injuries almost identically compared to whole-body CT in this population. Whole-body MRI could be a radiation-free approach for slightly to moderately injured young trauma patients.

Feasibility and Acceptability of the Novel Tu'Washindi Intervention to Increase PrEP Use among Adolescent Girls and Young Women in Siaya County, Kenya.

The Tu'Washindi intervention addressed intimate partner violence (IPV) and relationship dynamics to increase PrEP use among adolescent girls and young women (AGYW) in Siaya County, Kenya. We evaluated feasibility and acceptability in a cluster-randomized trial in six DREAMS Safe Spaces. The multilevel intervention, delivered over 6 months, included three components delivered by DREAMS staff with support from the study team: an 8-session structured support club; community sensitization of male partners; and a couples PrEP education and health fair ("Buddy Day"). Feasibility and acceptability assessments included implementation process measures, questionnaires, and focus group discussions with AGYWs and post-intervention questionnaires with intervention providers. The study included 103 AGYWs aged 17 to 24 (N = 49 intervention), with 97% retention. Median age was 22, 54% were married, and 84% were mothers. At enrollment, 45% used PrEP and 61% reported lifetime IPV. All intervention participants attended at least one support club session (mean = 5.2 of 8) and 90% attended Buddy Day. At 6 months, most participants perceived Tu'Washindi to be effective: all agreed (with 54% reporting "strongly agree") that the intervention improved partner communication and 60% agreed they were better able to gain partner support for their PrEP use. Providers believed the intervention resonated with community values. Tu'Washindi was highly acceptable and feasible and it was perceived by AGYW participants and providers as being effective in improving partner relationships and supporting PrEP use.

Optimizing shoulder elevation assist rate in exoskeletal rehabilitation based on muscular activity indices: a clinical feasibility study.

BACKGROUND: Restoring shoulder function is critical for upper-extremity rehabilitation following a stroke. The complex musculoskeletal anatomy of the shoulder presents a challenge for safely assisting elevation movements through robotic interventions. The level of shoulder elevation assistance in rehabilitation is often based on clinical judgment. There is no standardized method for deriving an optimal level of assistance, underscoring the importance of addressing abnormal movements during shoulder elevation, such as abnormal synergies and compensatory actions. This study aimed to investigate the effectiveness and safety of a newly developed shoulder elevation exoskeleton robot by applying a novel optimization technique derived from the muscle synergy index. METHODS: Twelve chronic stroke participants underwent an intervention consisting of 100 robot-assisted shoulder elevation exercises (10 × 10 times, approximately 40 min) for 10 days (4-5 times/week). The optimal robot assist rate was derived by detecting the change points using the co-contraction index, calculated from electromyogram (EMG) data obtained from the anterior deltoid and biceps brachii muscles during shoulder elevation at the initial evaluation. The primary outcomes were the Fugl-Meyer assessment-upper extremity (FMA-UE) shoulder/elbow/forearm score, kinematic outcomes (maximum angle of voluntary shoulder flexion and elbow flexion ratio during shoulder elevation), and shoulder pain outcomes (pain-free passive shoulder flexion range of motion [ROM] and visual analogue scale for pain severity during shoulder flexion). The effectiveness and safety of robotic therapy were examined using the Wilcoxon signed-rank sum test. RESULTS: All 12 patients completed the procedure without any adverse events. Two participants were excluded from the analysis because the EMG of the biceps brachii was not obtained. Ten participants (five men and five women; mean age: 57.0 [5.5] years; mean FMA-UE total score: 18.7 [10.5] points) showed significant improvement in the FMA-UE shoulder/elbow/forearm score, kinematic outcomes, and pain-free passive shoulder flexion ROM (P < 0.05). The shoulder pain outcomes remained unchanged or improved in all patients. CONCLUSIONS: The study presents a method for deriving the optimal robotic assist rate. Rehabilitation using a shoulder robot based on this derived optimal assist rate showed the possibility of safely improving the upper-extremity function in patients with severe stroke in the chronic phase.

The RELIEF feasibility trial: topical lidocaine patches in older adults with rib fractures.

BACKGROUND: Lidocaine patches, applied over rib fractures, may reduce pulmonary complications in older patients. Known barriers to recruiting older patients in emergency settings necessitate a feasibility trial. We aimed to establish whether a definitive randomised controlled trial (RCT) evaluating lidocaine patches in older patients with rib fracture(s) was feasible. METHODS: This was a multicentre, parallel-group, open-label, feasibility RCT in seven hospitals in England and Scotland. Patients aged ≥65 years, presenting to ED with traumatic rib fracture(s) requiring hospital admission were randomised to receive up to 3×700 mg lidocaine patches (Ralvo), first applied in ED and then once daily for 72 hours in addition to standard care, or standard care alone. Feasibility outcomes were recruitment, retention and adherence. Clinical end points (pulmonary complications, pain and frailty-specific outcomes) and patient questionnaires were collected to determine feasibility of data collection and inform health economic scoping. Interviews and focus groups with trial participants and clinicians/research staff explored the understanding and acceptability of trial processes. RESULTS: Between October 23, 2021 and October 7, 2022, 206 patients were eligible, of whom 100 (median age 83 years; IQR 74-88) were randomised; 48 to lidocaine patches and 52 to standard care. Pulmonary complications at 30 days were determined in 86% of participants and 83% of expected 30-day questionnaires were returned. Pulmonary complications occurred in 48% of the lidocaine group and 59% in standard care. Pain and some frailty-specific outcomes were not feasible to collect. Staff reported challenges in patient compliance, unfamiliarity with research measures and overwhelming the patients with research procedures. CONCLUSION: Recruitment of older patients with rib fracture(s) in an emergency setting for the evaluation of lidocaine patches is feasible. Refinement of data collection, with a focus on the collection of pain, frailty-specific outcomes and intervention delivery are needed before progression to a definitive trial. TRIAL REGISTRATION NUMBER: ISRCTN14813929.

Intervention to increase colorectal cancer screening among emergency department patients: results from a randomised pilot study.

BACKGROUND: Colorectal cancer (CRC) is the second leading cause of cancer-related deaths worldwide. Emergency departments (ED) represent a promising setting to address preventive health measures like CRC screening. OBJECTIVES: The current study adapted an existing cervical cancer screening intervention for use in catalysing CRC screening. We evaluated feasibility of identification, provided preliminary effect size estimates and documented participant acceptability. METHODS: This study was funded by the University of Rochester (ClinicalTrials.gov # NCT05004376). We enrolled ED patients, 45-75 years old, in the Greater Rochester, NY region into a randomised controlled pilot from January to May 2022. Patients were excluded if non-English speaking, lacking a cell phone or had a history of CRC, colorectal resection, inflammatory bowel disease or abdominal radiation. Participants were surveyed to determine adherence with recommended CRC screening guidelines. Patients found non-adherent were randomised to receive (1) recommendation for CRC screening only or (2) recommendation and a text-based intervention aimed at generating intention and motivation to get screened. Patients were blind to allocation at enrolment. The primary outcome was patient CRC screening or scheduling. RESULTS: 1438 patients were approached, with 609 found ineligible, 576 declining participation and 253 enrolled. A randomised sample of 114 non-adherent patients were split evenly between the control and intervention arms. Among participants with follow-up data (n control=38, n intervention=36), intervention participants had a 2%-3% higher rate of scheduling or receiving screening (7%-27% relative improvement). When using the complete sample (n=114) and conservatively assuming no screening for those lost to follow-up, differences in screening across arms were mildly decreased (0%-2% absolute difference). Acceptability of CRC intervention was high, and participants offered formative feedback. CONCLUSION: The piloted text message intervention through the ED shows potential promise for catalysing CRC screening. Subsequent replication in a fully powered trial is needed.

Using Physiological Markers to Assess Comfort during Neuromuscular Electrical Stimulation Induced Muscle Contraction in a Virtually Guided Environment: Pilot Study for a Path toward Combating ICU-Acquired Weakness.

We assessed the feasibility of implementing a virtually guided Neuromuscular Electrical Stimulation (NMES) protocol over the tibialis anterior (TA) muscle while collecting heart rate (HR), Numeric Pain Rating Scale (NPRS), and quality of contraction (QoC) data. We investigated if HR, NPRS, and QoC differ ON and OFF the TA motor point and explored potential relationships between heart rate variability (HRV) and the NPRS. Twelve healthy adults participated in this cross-sectional study. Three NMES trials were delivered ON and OFF the TA motor point. HR, QoC, and NPRS data were collected. There was no significant difference in HRV ON and OFF the motor point (p > 0.05). The NPRS was significantly greater OFF the motor point (p < 0.05). The QoC was significantly different between motor point configurations (p < 0.05). There was no correlation between the NPRS and HRV (p > 0.05, r = -0.129). We recommend non-electrical methods of measuring muscle activity for future studies. The NPRS and QoC can be administered virtually. Time-domain HRV measures could increase the validity of the protocol. The variables should be explored further virtually to enhance the protocol before eventual ICU studies.

A pilot study to evaluate the feasibility and potential effectiveness of an early palliative care model: "Educate, Nurture, Advise, Before Life Ends for Singapore".

OBJECTIVE: The main objective was to pilot the culturally adapted "Educate, Nurture, Advise, Before Life Ends" for Singapore (ENABLE-SG) model to evaluate its feasibility and potential effectiveness. METHODS: A single-arm pilot trial of ENABLE-SG among patients with advanced solid tumors and caregivers of these patients was conducted in the outpatient oncology clinic setting. Enrolled participants participated in individual ENABLE-SG psychoeducational sessions weekly. Patients had 6 sessions on the topics of maintaining positivity, self-care, coping with stress, managing symptoms, exploring what matters most and life review. Caregivers had 4 sessions on the topics of maintaining positivity, self-care, coping with stress and managing symptoms. At baseline, 4, 8, and 12 months after enrolment, patient's quality of life was measured using the Functional Assessment of Chronic Illness Therapy - Palliative Care, patient's mood was measured using the Center for Epidemiologic Studies - Depression scale, and caregiver quality of life was measured using the Singapore Caregiver Quality of Life Scale. RESULTS: We enrolled 43 patients and 15 caregivers over a 10-month period from August 2021 to June 2022. Although there was a low approach-to-participation rate, most of those who enrolled completed all ENABLE-SG sessions - 72% for patients and 94% for caregivers. Caregivers had better quality of life over time, specifically in the subscales of mental well-being and experience-meaning. SIGNIFICANCE OF RESULTS: Based on findings from this study, we are planning a randomized waitlist-controlled trial of ENABLE-SG for patients with advanced cancer and their caregivers.

[Joint study of seclusion, mechanical restraint and chemical restraint: Pilot study in three French psychiatric hospitals]. / Étudier conjointement l'isolement, la contention mécanique et la contention chimique : étude pilote dans trois établissements psychiatriques français.

Psychiatric wards that only exceptionally use isolation and mechanical restraint may be suspected of using "chemical restraint". However, in the case of these services, the hypothesis of a reduction in the general level of restraint can also be formulated. Prior to a comprehensive study to test these hypotheses, the current research aims to assess indicators which define high levels of the use of these measures and a relevant sample. The study was conducted in three facilities with 254 hospitalized patients over a week. Five per cent experienced isolation, 2% mechanical restraint, and 13% received high doses of medication (including "as needed" treatments). These figures are below literature data and national averages. Variances exist among centers, with one showing higher percentages for all three measures. While confirming the feasibility of studying these measures together, the study suggests the need for longer observations and continuous evaluation of prescription practices to better reflect yearly isolation and restraint trends. Future studies should involve more centers and include case studies for a nuanced understanding of administration practices in relation to prescriptions.

Using Epidemiological Data to Inform Clinical Trial Feasibility Assessments: A Case Study.

BACKGROUND: Clinical trial enrollment and completion is challenging, with nearly half of all trials not being completed or not completed on time. In 2014, the National Institutes of Health StrokeNet in collaboration with stroke epidemiologists from GCNKSS (Greater Cincinnati/Northern Kentucky Stroke Study) began providing proposed clinical trials with formal trial feasibility assessments. Herein, we describe the process of prospective feasibility analyses using epidemiological data that can be used to improve enrollment and increase the likelihood a trial is completed. METHODS: In 2014, DEFUSE 3 (Endovascular Therapy Following Imaging Evaluation for Ischemic Stroke 3) trialists, National Institutes of Health StrokeNet, and stroke epidemiologists from GCNKSS collaborated to evaluate the initial inclusion/exclusion criteria for the DEFUSE 3 study. Trial criteria were discussed and an assessment was completed to evaluate the percent of the stroke population that might be eligible for the study. The DEFUSE 3 trial was stopped early with the publication of DAWN (Thrombectomy 6 to 24 Hours After Stroke With a Mismatch Between Deficit and Infarct), and the Wilcoxon rank-sum statistic was used to analyze whether the trial would have been stopped had the proposed changes not been made, following the DEFUSE 3 statistical analysis plan. RESULTS: After initial epidemiological analysis, 2.4% of patients with acute stroke in the GCNKSS population would have been predicted to be eligible for the study. After discussion with primary investigators and modifying 4 key exclusion criteria (upper limit of age increased to 90 years, baseline modified Rankin Scale broadened to 0-2, time since last well expanded to 16 hours, and decreased lower limit of National Institutes of Health Stroke Scale score to <6), the number predicted to be eligible for the trial increased to 4%. At the time of trial conclusion, 57% of the enrolled patients qualified only by the modified criteria, and the trial was stopped at an interim analysis that demonstrated efficacy. We estimated that the Wilcoxon rank-sum value for the unadjusted predicted enrollment would not have crossed the threshold for efficacy and the trial not stopped. CONCLUSIONS: Objectively assessing trial inclusion/exclusion criteria using a population-based resource in a collaborative and iterative process including epidemiologists can lead to improved recruitment and can increase the likelihood of successful trial completion.

Mobile Postoperative Symptom Intervention Tool and Biometric Monitoring After Radical Cystectomy: Pilot Study Evaluating Feasibility, Usability, and Potential Utility.

PURPOSE: Mobile health technology and integration of patient-reported outcome measures into clinical interventions have the potential to transform patient care. Though patient-reported outcome measure management has been shown to improve outcomes in ambulatory care settings, few studies have examined remote patient-reported outcome measure assessment after major cancer surgery. MATERIALS AND METHODS: A multiphased feasibility and usability study was designed. A mobile app-based postoperative symptom intervention tool was developed and evaluated by a focus group of bladder cancer patients and caregivers. Patients were prospectively accrued prior to cystectomy and asked to complete the daily mobile postoperative symptom intervention tool and wear biometric monitoring devices for 30 days post discharge. Retention, postoperative symptom intervention tool completion, and usability were assessed. Exploratory analysis of daily symptoms and patient-generated health information correlated signals with postsurgical complications and hospital readmission. RESULTS: Fifteen patients with a median age of 72 years completed 78% of daily surveys over the 30-day recovery period. Average time to complete the postoperative symptom intervention tool was 152 seconds. All patients agreed that the daily survey was easy to use, and most reported it would be a better way to communicate with the care team about symptoms than calling the clinic. Frequency and severity of patient-reported symptoms appeared to cluster prior to or at the time of complication or unplanned health care encounters on visual-analogue mapping. CONCLUSIONS: Using smartphone and wearable technology to capture patient-reported symptoms and biometric data is feasible and rated as highly usable by bladder cancer patients after cystectomy. Symptom scores may signal developing complications and help clinicians identify postsurgical patients who may benefit from intervention.

Early feasibility studies in the United States: Focus on electrophysiology.

The care of patients with heart rhythm disorders is often dependent on technologies developed to address their unique clinical needs. Although much innovation occurs in the United States, recent decades have seen a significant proportion of early clinical studies performed outside the United States, driven largely by costly and time-inefficient processes seemingly inherent to the United States research ecosystem. As a result, the goals of early patient access to novel devices to address unmet needs and efficient technology development in the United States remain incompletely realized. This review will introduce key aspects of this discussion, organized by the Medical Device Innovation Consortium, in an effort to broaden awareness and encourage engagement by stakeholders in an effort to address central issues and therefore further a growing effort to shift Early Feasibility Studies to the United States for the benefit of all involved.

A virtual, group-based mindfulness intervention for midlife and older women with low libido lowers sexual distress in a randomized controlled pilot study.

BACKGROUND: Distressing low libido is common among women and has significant negative impacts; mindfulness has shown promise to increase sexual desire in women with low libido, but existing interventions are not tailored to midlife and older women. AIM: We adapted a mindfulness intervention to meet the needs of this population and conducted a pilot randomized controlled trial to assess feasibility and acceptability. METHODS: Women aged ≥45 years with low libido were randomized to the mindfulness intervention or an education group that met over videoconferencing. The intervention included mindfulness instruction and practice, group discussion, and education on sexuality and aging. The education group included general information on menopause and health. OUTCOMES: We defined feasibility by the number of screened women who enrolled and completed their group. We defined acceptability as satisfaction with the group and likelihood of recommending it to another woman with low libido. We assessed sexual function (Female Sexual Function Index) and sexual distress (Female Sexual Distress Scale-Revised) at 6 weeks postconclusion. RESULTS: Of 81 women screened, 31 were randomized to mindfulness and 30 to education. Eighteen women in the intervention group and 23 in the control group attended at least 1 session. Time conflict was the main reason for nonattendance. Of the 41 women who started attending groups, 37 (90%) attended at least 5 sessions. In the mindfulness group, 73% of women were very or extremely satisfied. Women in the mindfulness group were more likely to recommend it to another person with low libido as compared with those in the education group (P = .031); 67% said that they would probably or definitely recommend it. There were no significant changes in sexual function in either group (mean Female Sexual Function Index score, 22.6 to 18.6 [P = .101] with mindfulness and 21.2 to 19.7 [P = .537] with education). Women in the mindfulness group had significant improvements in sexual distress (mean Female Sexual Distress Scale-Revised score, 27.1 to 19.7; P = .021) while women in the education group did not (19.0 to 15.8; P = .062). CLINICAL IMPLICATIONS: Mindfulness may reduce sexual distress in older women with low libido. STRENGTHS AND LIMITATIONS: This is the first trial testing mindfulness for midlife and older women with low libido. CONCLUSION: A virtual mindfulness intervention for midlife and older women with low libido is feasible and acceptable and appears to improve sexual distress as compared with an education control; these findings provide data that can be used to design a larger clinical trial.

Contrast-enhanced mammography-guided biopsy: technical feasibility and first outcomes.

OBJECTIVES: To evaluate the feasibility of contrast-enhanced mammography (CEM)-guided biopsy at Hospital del Mar, a Spanish university hospital. METHODS: We retrospectively reviewed all consecutive women with a suspicious enhancing finding eligible for CEM-guided biopsy, who were prospectively enrolled in a pre-marketing clinical validation and feasibility study (October 2019 to September 2021). CEM-guided biopsy is a stereotactic-based procedure that, by using intravenous iodinated contrast media administration and dual-energy acquisition, provides localisation of enhancing lesions. All the biopsies were performed using a vacuum-assisted device. We collected procedural characteristics (patient position and type of approach), and histopathological results. Feasibility endpoints included success (visualisation of the enhancing lesion, post-procedural biopsy changes and clip placement), procedural time, number of scout acquisitions and complications. RESULTS: A total of 66 suspicious enhancing lesions (18.0% foci, 44.0% mass, 38.0% non-mass enhancement; median size 8.5 mm) in 64 patients (median age 59 years, mostly minimal [48.4%] or mild [32.8%] background parenchymal enhancement) were referred for CEM-guided biopsy in the study period. The success rate was 63/66 (95.4%). Amongst successful procedures, patients were most frequently seated (52/63, 82.5%) and the preferred approach was horizontal (48/63, 76.2%). Median total time per procedure was 15 min. Median number of acquisitions needed before targeting was 2 (range 1-4). Complications consisted of hematoma (17/63, 27%) and vasovagal reaction (2/63, 3.2%). At histology, the malignancy rate was 25/63 (39.7%). CONCLUSION: In this first patient series, CEM-guided breast biopsy was feasible, with success and complication rates similar to those previously reported for magnetic resonance guidance. KEY POINTS: • CEM may be used to guide biopsy of enhancing lesions through a stereotactic-based procedure combined with intravenous iodinated contrast media administration and dual-energy acquisition. • In this first patient series (n = 64), the success rate of CEM-guided biopsy was above 95%, the only complications were hematoma (22.2%) and vasovagal reaction (3.2%), and median total time per procedure was 15 min. • CEM-guided biopsy is feasible and could potentially be a widely available biopsy technique for enhancing-only lesions.

Radiologic-pathologic correlation of lesions in resected liver specimens with an ex vivo MRI-compatible localization device.

OBJECTIVE: Liver lesion characterization is limited by the lack of an established gold standard for precise correlation of radiologic characteristics with their histologic features. The objective of this study was to demonstrate the feasibility of using an ex vivo MRI-compatible sectioning device for radiologic-pathologic co-localization of lesions in resected liver specimens. METHODS: In this prospective feasibility study, adults undergoing curative partial hepatectomy from February 2018 to January 2019 were enrolled. Gadoxetic acid was administered intraoperatively prior to hepatic vascular inflow ligation. Liver specimens were stabilized in an MRI-compatible acrylic lesion localization device (27 × 14 × 14 cm3) featuring slicing channels and a silicone gel 3D matrix. High-resolution 3D T1-weighted fast spoiled gradient echo and 3D T2-weighted fast-spin-echo images were acquired using a single channel quadrature head coil. Radiologic lesion coordinates guided pathologic sectioning. A final histopathologic diagnosis was prepared for all lesions. The proportion of successfully co-localized lesions was determined. RESULTS: A total of 57 lesions were identified radiologically and sectioned in liver specimens from 10 participants with liver metastases (n = 8), primary biliary mucinous cystic neoplasm (n = 1), and hepatic adenomatosis (n = 1). Of these, 38 lesions (67%) were < 1 cm. Overall, 52/57 (91%) of radiologically identified lesions were identified pathologically using the device. Of these, 5 lesions (10%) were not initially identified on gross examination but were confirmed histologically using MRI-guided localization. One lesion was identified grossly but not on MRI. CONCLUSIONS: We successfully demonstrated the feasibility of a clinical method for image-guided co-localization and histological characterization of liver lesions using an ex vivo MRI-compatible sectioning device. KEY POINTS: • The ex vivo MRI-compatible sectioning device provides a reliable method for radiologic-pathologic correlation of small (< 1 cm) liver lesions in human liver specimens. • The sectioning method can be feasibly implemented within a clinical practice setting and used in future efforts to study liver lesion characterization. • Intraoperative administration of gadoxetic acid results in enhancement in ex vivo MRI images of liver specimens hours later with excellent image quality.

Early assessment of acute kidney injury in severe acute pancreatitis with multimodal DWI: an animal model.

OBJECTIVES: To evaluate the feasibility of multimodal diffusion-weighted imaging (DWI) for detecting the occurrence and severity of acute kidney injury (AKI) caused by severe acute pancreatitis (SAP) in rats. METHODS: SAP was induced in thirty rats by the retrograde injection of 5.0% sodium taurocholate through the biliopancreatic duct. Six rats underwent MRI of the kidneys 24 h before and 2, 4, 6, and 8 h after this AKI model was generated. Conventional and functional MRI sequences were used, including intravoxel incoherent motion imaging (IVIM), diffusion tensor imaging (DTI), and diffusion kurtosis imaging (DTI). The main DWI parameters and histological results were analyzed. RESULTS: The fast apparent diffusion coefficient (ADC) of the renal cortex was significantly reduced at 2 h, as was the fractional anisotropy (FA) value of the renal cortex on DTI. The mean kurtosis (MK) values for the renal cortex and medulla gradually increased after model generation. The renal histopathological score was negatively correlated with the medullary slow ADC, fast ADC, and perfusion scores for both the renal cortex and medulla, as were the ADC and FA values of the renal medulla in DTI, whereas the MK values of the cortex and medulla were positively correlated (r = 0.733, 0.812). Thus, the cortical fast ADC, medullary MK, FADTI, and slow ADC were optimal parameters for diagnosing AKI. Of these parameters, cortical fast ADC had the highest diagnostic efficacy (AUC = 0.950). CONCLUSIONS: The fast ADC of the renal cortex is the core indicator of early AKI, and the medullary MK value might serve as a sensitive biomarker for grading renal injury in SAP rats. CLINICAL RELEVANCE STATEMENT: The multimodal parameters of renal IVIM, DTI, and DKI are potential beneficial for the early diagnosis and severity grading of renal injury in SAP patients. KEY POINTS: • The multimodal parameters of renal DWI, including IVIM, DTI, and DKI, may be valuable for the noninvasive detection of early AKI and the severity grading of renal injury in SAP rats. • Cortical fast ADC, medullary MK, FA, and slow ADC are optimal parameters for early diagnosis of AKI, and cortical fast ADC has the highest diagnostic efficacy. • Medullary fast ADC, MK, and FA as well as cortical MK are useful for predicting the severity grade of AKI, and the renal medullary MK value exhibits the strongest correlation with pathological scores.

Diffusion-time dependent diffusion MRI: effect of diffusion-time on microstructural mapping and prediction of prognostic features in breast cancer.

OBJECTIVES: This study aimed to evaluate the effect of achievable td on the accuracy of microstructural mapping based on simulation and patient experiments, and investigate the feasibility of td-dMRI in distinguishing prognostic factors in breast cancer patients. METHODS: Simulation was performed using different td settings. Patients with breast cancer were enrolled prospectively between November 2020 and January 2021, who underwent oscillating and pulsed gradient encoded dMRI on a 3-T scanner using short-/long-td protocol with oscillating frequency up to 50/33 Hz. Data were fitted with a two-compartment model to estimate cell diameter (d), intracellular fraction (fin), and diffusivities. Estimated microstructural markers were used to differentiate immunohistochemical receptor status and the presence of lymph node (LN), which were correlated with histopathological measurements. RESULTS: Simulation results showed that d fitted from the short-td protocol significantly reduced estimation error than those from long-td (2.07 ± 1.51% versus 3.05 ± 1.92%, p < 0.0001) while the estimation error of fin was robust to different protocols. Among a total of 37 breast cancer patients, the estimated d was significantly higher in HER2-positive and LN-positive (p < 0.05) groups compared to their negative counterparts only using the short-td protocol. Histopathological validation in a subset of 6 patients with whole slide images showed the estimated d was highly correlated with measurements from H&E staining (r = 0.84, p = 0.03) only using the short-td protocol. CONCLUSIONS: The results indicated the necessity of short-td for accurate microstructural mapping in breast cancer. The current td-dMRI with a total acquisition time of 4.5 min showed its potential in the diagnosis of breast cancer. KEY POINTS: • Short td is important for accurate microstructural mapping in breast cancer using the td-dMRI technique, based on simulation and histological validation. • The 4.5-min td-dMRI protocol showed potential clinical value for breast cancer, given the difference in cell diameter between HER2/LN positive and negative groups.

Point-of-care testing in private pharmacy and drug retail settings: a narrative review.

BACKGROUND: Point-of-care testing (POCT) using rapid diagnostic tests for infectious disease can potentially guide appropriate use of antimicrobials, reduce antimicrobial resistance, and economise use of healthcare resources. POCT implementation in private retail settings such as pharmacies and drug shops could lessen the burden on public healthcare. We performed a narrative review on studies of POCTs in low- and middle-income countries (LMICs), and explored uptake, impact on treatment, and feasibility of implementation. METHODS: We searched MEDLINE/PubMed for interventional studies on the implementation of POCT for infectious diseases performed by personnel in private retail settings. Data were extracted and analysed by two independent reviewers. RESULTS: Of the 848 studies retrieved, 23 were included in the review. Studies were on malaria (19/23), malaria and pneumonia (3/23) or respiratory tract infection (1/23). Nine randomised controlled studies, four controlled, non-randomised studies, five uncontrolled interventions, one interventional pre-post study, one cross-over interventional study and three retrospective analyses of RCTs were included. Study quality was poor. Overall, studies showed that POCT can be implemented successfully, leading to improvements in appropriate treatment as measured by outcomes like adherence to treatment guidelines. Despite some concerns by health workers, customers and shop providers were welcoming of POCT implementation in private retail settings. Main themes that arose from the review included the need for well-structured training with post-training certification covering guidelines for test-negative patients, integrated waste management, community sensitization and demand generation activities, financial remuneration and pricing schemes for providers, and formal linkage to healthcare and support. CONCLUSION: Our review found evidence that POCT can be implemented successfully in private retail settings in LMICs, but comprehensive protocols are needed. High-quality randomised studies are needed to understand POCTs for infectious diseases other than malaria.

Statins as an antiepileptogenic or disease-modifying treatment? A survey of what UK patients and significant others think about repurposing and trialing them for epilepsy.

OBJECTIVE: To identify the views of people with epilepsy (PWE), and their significant others, on the repurposing and trialing of statins as a potential antiepileptogenic or disease-modifying treatment for those who have had the first seizure. METHODS: Online questionnaire. Participants needed to be aged ≥ 16 years, UK residents, and able to independently complete a questionnaire in English. User groups distributed study adverts. Embedded infographics explained repurposing, why anti-seizure treatment is not typically started after a first seizure and the nature of randomized placebo-controlled trials (RCTs). The questionnaire asked participants to reflect and rate their expected willingness to have started an unspecified treatment after their first seizure/s (or that of the person with epilepsy they knew). They also rated willingness if the treatment were a statin, views of statins, the importance of an RCT of statins to their community, the outcomes it should assess, and their willingness to have taken part in it. The estimated number needed for the survey was 324. RESULTS: Responses from 213 persons were analyzed; 111 (52.1%) were PWE and 102 (47.9%) significant others. The median years diagnosed was 10 and PWE suffered from relatively severe epilepsy. One hundred and seventeen (54.9%) said they would have started an unspecified treatment after their first seizure/s (or supported the person with epilepsy they knew to have). A similar proportion (55.4%) said they would have started the treatment if it were a statin. Participants' main concern about statins, expressed by 79%, was their possible side effects. Repurposing was a concern for only 25%. Most (85.8%) rated an RCT of statins as of extreme or high importance; 54.4% said they would have participated. CONCLUSION: The PWE and significant others (SOs) responding to our survey expressed views towards repurposing statins that were generally positive and indicate a trial in those who have had a first seizure might be feasible. Concerns regarding side effects are common. Our findings could help optimize a future trial's design and the case for funding. Limitations include that we did not survey persons who had experienced a first seizure and did not go on to develop epilepsy. Also, persons with uncontrolled epilepsy were overrepresented.