Ultraviolet A1 Phototherapy for Improvement of Hand Function in Scleroderma: A Blinded Prospective Study.

In some centers where brain tumor surgery is performed, the opportunity for expert intraoperative neuropathology consultation is lacking. Consequently, surgeons may not have access to the highest quality diagnostic histological data to inform surgical decision-making. Stimulated Raman histology (SRH) is a novel technology that allows for rapid acquisition of diagnostic histological images at the bedside. The authors performed a prospective blinded cohort study of 82 consecutive patients undergoing resection of CNS tumors to compare diagnostic time and accuracy of SRH simulation to the gold standard, i.e., frozen and permanent section diagnosis. Diagnostic accuracy was determined by concordance of SRH-simulated intraoperative pathology consultation with a blinded board-certified neuropathologist, with official frozen section and permanent section results. Overall, the mean time to diagnosis was 30.5 ± 13.2 minutes faster (p < 0.0001) for SRH simulation than for frozen section, with similar diagnostic correlation: 91.5% (κ = 0.834, p < 0.0001) between SRH simulation and permanent section, and 91.5% between frozen and permanent section (κ = 0.894, p < 0.0001). SRH-simulated intraoperative pathology consultation was significantly faster and equally accurate as frozen section.

Comparison of Immediate Postoperative Walking Ability in Patients Receiving Minimally Invasive and Standard-Incision Hip Arthroplasty: A Prospective Blinded Study

A prospective blinded study on emergency pain assessment and therapy

A prospective blinded study on emergency pain assessment and therapy

10505 Background: We developed a specific method for circulating cell-free DNA (ctDNA) enabling the detection of point mutations. CtDNA exists at high level in patients with different types of cancer, and presents great potential in regards, in particular, to its low invasiveness, rapid data turnaround and cost effectiveness. We described here the first blinded prospective study on the comparison of KRAS and BRAF mutational status data obtained from the analysis of ctDNA and tumor section. Methods: Intplex is a refined Q-PCR-based method specifically designed to analyze ctDNA. IntPlex allows not only the detection of point mutations, but also the determination of tumor-ctDNA concentration and fragmentation index simultaneously. Intplex sensitivity is 0.01% (mutant to WT ratio) and is unprecedented among Q-PCR-based methods. The study was conducted from a multicenter cohort of 79 metastatic CRC patients not having received chemo- or radio-therapy within the month prior to blood sample collection. Results: Mutational status could not be determined in 9 samples with one of the two methods. CtDNA analysis showed 100% specificity and 87% sensitivity for KRAS detection (only three samples are misclassified) as compared to tumor section analysis with 23/70 (33%) positive samples, the concordance value being 96%. For BRAF mutation, the method exhibited a specificity and a sensibility of 100% with 5/70 (7%) positive samples (concordance of 100%). When combining KRAS and BRAF mutations, 100% specificity, 89% sensibility and 98% concordance were determined. The three discordant samples may be explained by the malignant genotype of primary tumor versus metastasis, or by the sensitivity of our detection method. The mutation load (median, 12.4%) expressed as the proportion of mutant allele in ctDNA is highly variable (0.037% to 69%) among mutated samples showing a very high inter-individual heterogeneity. Conclusions: Our blinded prospective multicenter study clearly showed for the first time that tumor section analysis might be advantageously replaced by ctDNA analysis, enlarging personalized medicine power for cancer patients.

Cytologic Evaluation of Cystic Pancreatic Lesions (CPL): Comparison of EchoBrush Vs. Standard EUS-FNA Techniques in a Blinded Prospective Study

2079870 Quick and Easy Detection Method of Liver Tumor With New Technology for US

BackgroundFetal weight estimation is of key importance in the decision-making process for obstetric planning and management. The literature is inconsistent on the accuracy of measurements with either ultrasound or clinical examination, known as Leopold’s manoeuvres, shortly before term. Maternal BMI is a confounding factor because it is associated with both the fetal weight and the accuracy of fetal weight estimation. The aim of our study was to compare the accuracy of fetal weight estimation performed with ultrasound and with clinical examination with respect to BMI.MethodsIn this prospective blinded observational study we investigated the accuracy of clinical examination as compared to ultrasound measurement in fetal weight estimation, taking the actual birth weight as the gold standard.In a cohort of all consecutive patients who presented in our department from January 2016 to May 2017 to register for delivery at ≥37 weeks, examination was done by ultrasound and Leopold’s manoeuvres to estimate fetal weight. All examiners (midwives and physicians) had about the same level of professional experience.The primary aim was to compare overall absolute error, overall absolute percent error, absolute percent error > 10% and absolute percent error > 20% for weight estimation by ultrasound and by means of Leopold’s manoeuvres versus the actual birth weight as the given gold standard, namely separately for normal weight and for overweight pregnant women.ResultsFive hundred forty-three patients were included in the data analysis. The accuracy of fetal weight estimation was significantly better with ultrasound than with Leopold’s manoeuvres in all absolute error calculations made in overweight pregnant women. For all error calculations performed in normal weight pregnant women, no statistically significant difference was seen in the accuracy of fetal weight estimation between ultrasound and Leopold’s manoeuvres.ConclusionsData from our prospective blinded observational study show a significantly better accuracy of ultrasound for fetal weight estimation in overweight pregnant women only as compared to Leopold’s manoeuvres with a significant difference in absolute error. We did not observe significantly better accuracy of ultrasound as compared to Leopold’s manoeuvres in normal weight women. Further research is needed to analyse the situation in normal weight women.

IntroductionTimely matching of patients to beneficial targeted therapy is an unmet need in rheumatoid arthritis (RA). A molecular signature response classifier (MSRC) that predicts which patients with RA are unlikely to respond to tumor necrosis factor-α inhibitor (TNFi) therapy would have wide clinical utility.MethodsThe protein–protein interaction map specific to the rheumatoid arthritis pathophysiology and gene expression data in blood patient samples was used to discover a molecular signature of non-response to TNFi therapy. Inadequate response predictions were validated in blood samples from the CERTAIN cohort and a multicenter blinded prospective observational clinical study (NETWORK-004) among 391 targeted therapy-naïve and 113 TNFi-exposed patient samples. The primary endpoint evaluated the ability of the MSRC to identify patients who inadequately responded to TNFi therapy at 6 months according to ACR50. Additional endpoints evaluated the prediction of inadequate response at 3 and 6 months by ACR70, DAS28-CRP, and CDAI.ResultsThe 23-feature molecular signature considers pathways upstream and downstream of TNFα involvement in RA pathophysiology. Predictive performance was consistent between the CERTAIN cohort and NETWORK-004 study. The NETWORK-004 study met primary and secondary endpoints. A molecular signature of non-response was detected in 45% of targeted therapy-naïve patients. The MSRC had an area under the curve (AUC) of 0.64 and patients were unlikely to adequately respond to TNFi therapy according to ACR50 at 6 months with an odds ratio of 4.1 (95% confidence interval 2.0–8.3, p value 0.0001). Odds ratios (3.4–8.8) were significant (p value < 0.01) for additional endpoints at 3 and 6 months, with AUC values up to 0.74. Among TNFi-exposed patients, the MSRC had an AUC of up to 0.83 and was associated with significant odds ratios of 3.3–26.6 by ACR, DAS28-CRP, and CDAI metrics.ConclusionThe MSRC stratifies patients according to likelihood of inadequate response to TNFi therapy and provides patient-specific data to guide therapy choice in RA for targeted therapy-naïve and TNFi-exposed patients.Supplementary InformationThe online version contains supplementary material available at 10.1007/s40744-021-00330-y.

IntroductionMorphea (localized scleroderma) is an inflammatory connective tissue disease, characterized by immune system dysfunction, vasculopathy and skin fibrosing. Phototherapy has been found to be effective in treating localized scleroderma. Psoralen + ultraviolet A (PUVA) and ultraviolet A1 (UVA1) phototherapy significantly enriched therapeutic possibilities.AimTo compare the clinical effect of PUVA photochemotherapy and UVA1 phototherapy and to evaluate the treatment response rates.Material and methodsIt was a retrospective one-centre research and observational study of all morphea patients treated with PUVA and UVA phototherapy. We reviewed phototherapy notes along with electronic and paper case records for all patients with morphea treated with PUVA and UVA1 phototherapy from January 2010 to December 2019.ResultsThe study shows that patients in both groups experienced improvement based on clinical measures, resulting in a reduction in the clinical score in all groups. There is positive short- and long-term efficacy of UVA1 and PUVA phototherapy in patients with morphea. There were no statistical differences between the treatment response rates. Limitations: We had a relatively small study sample and it was a retrospective, observational study.ConclusionsOur data suggest that ultraviolet PUVA and UVA1 should be considered for the treatment of morphea with disseminated lesions or not responding to topical treatment. UVA1 is free of side effects linked to oral psoralens such as nausea, vomiting, photokeratosis, but we showed that there was no statistical advantage in the effectiveness of both. UVA1 phototherapy is, however, a less accessible form of treatment, available in the centres of higher quality.

Background: Previous case reports hint ultraviolet A1 (UVA1) phototherapy as a novel adjunct treatment for acute cutaneous inflammations and neuralgia of herpes zoster, but its clinical effectiveness and safety in this condition are not yet proven by clinical trials. Objectives: To determine the efficacy and safety of UVA1 phototherapy as an adjunct treatment for acute inflammation and neuralgia in herpes zoster. Methods: A total of 60 patients with moderate-to-severe acute herpes zoster were randomly divided into two parallel groups. Group I received regular treatment and UVA1, and Group II received regular treatment alone. Time of blister crusting and acute erythema subside, assessment of pain, sleep, anxiety, and quality of life were recorded accordingly. Results: In Groups I and II, 28 and 29 patients completed the treatment and follow-up, respectively, with no significant demographic or baseline differences. UVA1 therapy notably reduced blister crusting time and acute erythema subside time and achieved more rapid pain relief within the first 2 weeks. However, it did not significantly alter the rate of postherpetic neuralgia occurrence. Additionally, UVA1 therapy significantly improved anxiety and quality of life scores at the 2-week mark. The primary adverse effects were mild burning and hyperpigmentation at the treatment site. Conclusions: UVA1 phototherapy as an adjunct treatment can expedite the resolution of acute inflammatory cutaneous lesions and neuralgia associated with herpes zoster, providing swifter relief from anxiety and enhancing patient quality of life during the acute phase, with demonstrated good tolerability and safety.

Objective This study aimed to clinically validate the performance of a multi-feature AI-based solution on detection of invasive versus in situ carcinomas and in situ ductal carcinoma high grade from atypical ductal hyperplasia/low grade DCIS compared to rigorous ground truth (GT) established by multiple blinded expert pathologists in breast biopsies. Design Performance of the AI solution was prospectively tested on breast biopsies from two medical institutions in different geographies. AI results were compared against the ground truth (GT) established by consensus of two subspecialist breast pathologists. The study endpoints were detection of invasive carcinoma (IDC, ILC) and DCIS/ADH, including differentiating between different DCIS grades and ADH. ADH and DCIS Low Grade were pooled together because of similar clinical management when diagnosed on a biopsy. Results Six pathologists participated in the study and reported on 436 breast biopsies (841 H&amp;E slides), including 156 invasive (including 31 rare subtypes), 135 DCIS/ADH and 145 benign diagnoses. The AI solution demonstrated high performance when compared with the GT with an AUC of 0.99 for the detection of invasive carcinoma (specificity and sensitivity of 93.6% and 95.5% respectively) and with AUC of 0.95 for the detection of DCIS/ADH. The AI solution differentiated well between subtypes/grades of invasive and in-situ cancers with an AUC of 0.97 for IDC vs. ILC and AUC of 0.92 for DCIS high grade vs. low grade/ADH, respectively. Only 11 (7%) cases had discrepancies on invasive diagnosis, 4 of these between invasive versus benign diagnosis encompassing one case on which the invasive component was only represented by rare lympho-vascular invasion, two cases of ILC (one with a diffuse pattern and the second in a case with granulomatous mastitis with multinucleated giant cells and hemosiderin-laden macrophages) and one rare case of tubular carcinoma surrounded by flat epithelial atypia and columnar cell lesions. Fifteen cases (11%) had discrepancies on DCIS/ADH diagnosis between the two specialist pathologists necessitating a third assessment by a specialist to establish GT. Six of these cases also necessitated a review on a multihead microscope to reach a consensus decision, since there was no majority even after 3 reviews. Conclusion This blinded multi-site study reports the successful clinical validation of a multi-feature AI-based solution in detecting and automatically imparting clinically relevant diagnostic parameters regarding invasive and in situ breast carcinoma, offering an important tool for computer-aided diagnosis in routine pathology practice. Citation Format: Anne Vincent-Salomon, Guillaume Bataillon, Alona Nudelman, Judith Sandbank, Anat Albrecht Shach, Lucie Thibault, Lilach Bien, Rachel Mikulinsky, Ira Krasnitsky, Ronen Heled, Chaim Linhart, Manuela Vecsler, Daphna Laifenfeld. A multi-feature AI-based solution for cancer diagnosis in breast biopsies: A prospective blinded multi-site clinical study [abstract]. In: Proceedings of the 2021 San Antonio Breast Cancer Symposium; 2021 Dec 7-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2022;82(4 Suppl):Abstract nr PD11-04.

Aim: To compare the efficacy of and safety of dexmeditomidine versus nitroglycerine during hypotensive anaesthesia induced by either drug in adult patients posted for elective spine surgeries. Material and Methods: This was a prospective, randomized, and double blinded clinical comparative study conducted in the Department of Anaesthesiology, ESIC Medical College, Sanath Nagar, Hyderabad, Telangana, India for the period of 1 year. 100 participants belonging to ASA class I or II between 20 and 55 years of age scheduled for elective spine surgeries were include in this study. The study drug dexmeditomidine was given to group DX in the dose of 1 micro gram/kg body weight in a 600 seconds infusion before induction diluted to 10 ml with normal saline followed by maintenance dose at infusion rate of 0.2- 0.7 microgm/kg. The group NG received 10 ml plain normal saline over 600 seconds before induction followed by maintenance dose of nitroglycerine at an infusion rate of 0.5-10 microgm/kg/min. different parameter were compared in both the groups.

Introduction:Aloe vera has been reported to have effects upon skin, joint pains and diabetes but without scientific evidence. It has never been studied in isolation as a single drug. Our study was a small study to study the symptom lowering effects of Aloe Vera gel when used in combination with a topical massage oil.Patients and Methods:A prospective double blind interventional study was conducted with patients of osteoarthritis knee randomized in two groups of patients (20 in each). Both groups were given topical oil for massage over the affected joints. They were provided oral analgesic tablets in fixed numbers and during follow up Visual analogue score and number of tablets used was taken as measure of alleviation of symptoms.Results:Both groups comprised of 20 subjects each and had similar characteristics for age/sex/laterality of joint involved. The epidemiological characteristics of the groups were similar. Group A used Topical Mas-sage Oil without addition of Aloe Vera Gel while Group B used the same oil with addition of the gel. It was observed that patients who had been given massage oil with addition of Aloe Vera gel showed less use of oral analgesics during study period and their VAS scores were less as compared to the Group A who were using the same massage oil but without Aloe Vera Gel.Conclusion:Aloe Vera as local application seems to improve pain relief and decrease oral analgesic use in patients of osteoarthritis knees who are being treated with local massage oils of alternative medical origin. Further studies need to be done to reach a conclusion.Key Words: Massage Oil, Aloe Vera, Analgesia.

DISCUSSION Although never published in hip arthroscopy, intra-articular injection of adrenaline with local anaesthetic has been described in knee arthroscopy over 20 years ago. Combined injection with adrenaline was found to be safe to establish clear arthroscopic view during anterior cruciate ligament reconstruction. Adrenaline irrigation during arthroscopic knee surgery can also reduce the need for tourniquet usage in 50% of cases. A prospective randomised, double blind and placebo controlled study showed significantly reduced intra-articular bleeding with adrenaline irrigation during shoulder arthroscopy. Visual field clarity during arthroscopy, rated on a visual analogue scale, was shown to be better in the adrenaline irrigation group. No cardiovascular adverse reactions were observed. In a more recent prospective, randomised, double blind study with 130 knee arthroscopy patients, adding adrenaline to injection fluid was associated with less bleeding at portal sites, shorter arthroscopy time, less irrigation fluid usage and better arthroscopic view. No significant changes in heart rate, mean arterial pressure or any other complications were reported.