Citations

AbstractBackgroundThe growing popularity of aesthetic procedures involving fillers, biostimulators, and neurotoxins has prompted concerns about patient safety. To address these concerns, a global Safety Task Force (STF) was formed.AimsThe inaugural STF meeting prioritized vascular compromise prevention and management, guiding clinical trial design and materials for future meetings, and collecting data from experts on current safety methods.MethodsThe STF was formed and consisted of 16 experts from nine different countries, with each possessing distinct expertise in various fields related to aesthetic injectables. Current safety data, protocols, knowledge gaps and future research priorities were discussed and voted upon.ResultsThe establishment of a global database for tracking filler‐related AEs was favored by 93% of participants. Discussions revolved around the database's scope, data standardization, and whether non‐medical contributors should be included. Aspiration as a safety technique garnered support from 73% of participants. Approximately 43% of participants incorporate ultrasound in their injections, with divergent opinions on its impact and potential when used as a standard of practice versus in AE management. Most physicians on the task force incorporated cannula use for some of their injections (93%). There were varying perspectives on treatments for vascular adverse events (VAE), the primary causes, and the adoption of new protocols in the field.ConclusionsThe STF meeting underscored the need for a coordinated effort to address complications related to HA fillers, including VAE management and hyaluronidase protocols. Reliable treatment endpoints were evaluated, but improved measurement methods are needed. Future meetings will focus on addressing delayed complications, furthering safety in this field.

AbstractBackground and ObjectivesManagement of myxofibrosarcoma (MFS) is widely debated, and there is no consensus regarding the effect of adjuvant therapies on local recurrence (LR), distant metastasis (DM), or overall survival (OS). This study aims to determine the effect of adjuvant therapies on the aforementioned outcomes in patients with MFS.MethodsWe conducted a systematic review via Medline, PubMed, CINAHL, Cochrane, Embase, and Google Scholar. Therapeutic studies that reported LR, DM, and OS following adjuvant therapies in patients with MFS were included. Statistical analysis and creation of hazard ratios were performed using Revman 5.3 (Cochrane Collaboration).ResultsWe identified 301 studies, 10 of which were included in the final analysis. Neither chemotherapy nor radiation affected the rate of LR (p = 0.73 and 0.17, respectively) or OS (p = 0.97 and 0.27, respectively). Chemotherapy was significantly associated with lower rates of DM (p = 0.03); however, there was no association between radiation and DM (p = 0.67).ConclusionThere is a lack of consensus regarding the effect of neoadjuvant and adjuvant therapies on LR, DM, and OS in patients with MFS. Our systematic review found that radiation and chemotherapy were not significantly associated with OS or LR in patients with MFS. However, we identified a significant association between chemotherapy and lower rates of DM.

Abstract Contemporary anticancer therapies frequently have different efficacy and side effects in men and women. Yet, whether women are well‐represented in pivotal trials supporting contemporary anticancer drugs is unknown. Leveraging the Drugs@FDA database, clinicaltrials.gov , MEDLINE, and publicly available FDA‐drug‐reviews, we identified all pivotal (phase II and III) non‐sex specific trials supporting FDA‐approval of anticancer drugs (1998–2018). Observed‐enrollment‐rates were compared to expected‐population‐rates derived from concurrent US‐National‐Cancer‐Institute's Surveillance‐Epidemiology‐and‐End‐Results (SEER) reported rates and US‐Census databases. Primary outcome was the proportional representation of women across trials, evaluated by a participation‐to‐prevalence ratio (PPR), according to cancer type. Secondary outcome was the report of any sex‐specific analysis of efficacy and/or safety, irrespective of treatment‐arm. Overall, there were 148 trials, enrolling 60,216 participants (60.5 ± 4.0 years, 40.7% female, 79.1% biologic, targeted, or immune‐based therapies) evaluating 99 drugs. Sex was reported in 146 (98.6%) trials, wherein 40.7% (24,538) were women, compared to 59.3% (35,678) men ( p < .01). Altogether, women were under‐represented in 66.9% trials compared to the proportional incidence of cancers by respective disease type; weight‐average PPR of 0.91 (relative difference: ‐9.1%, p < .01). Women were most under‐represented in gastric (PPR = 0.63), liver (PPR = 0.71), and lung (PPR = .81) cancer trials. Sex‐based safety data was reported in 4.0% trials. There was no association between adequate female enrollment and drug efficacy (HR: 0.616 vs. 0.613, p = .96). Over time, there was no difference in the percentage of women recruited into clinical trials. Among pivotal clinical trials supporting contemporary FDA‐approved cancer drugs, women were frequently under‐represented and sex‐specific‐efficacy and safety‐outcomes were commonly not reported.

Objectives: The purpose of this paper was to compare patient reported outcomes (PROMs) between isolated anterior cruciate ligament (ACLR) and ACLR with concomitant medial meniscus ramp and lateral meniscus root repairs and compare PROMs between different medial meniscus ramp and lateral meniscus root repair techniques. Methods: All patients with isolated (ISO) ACL reconstruction or ACL reconstruction with concomitant medial meniscus ramp and lateral meniscus root repairs with a minimum 2 years of follow-up were retrospectively evaluated. Institutional review board approval was obtained for this study. A final total of 42 ISO-ACL patients were matched based upon age, sex, and body mass index to 40 in the “terrible triad” (TT) cohorts. Outcome measures were obtained from 32 patients in the ISO cohort, and 38 patients in the TT cohort. The PROMs used for this study include the International Knee Documentation Committee (IKDC) Subjective Knee, Cincinnati, Tegner, Lysholm, Veterans RAND 12-Item Health Survey (VR-12), and Knee Injury and Osteoarthritis Outcomes Score (KOOS) questionnaire forms. T tests and chi-square goodness of fit tests were used to compare the above PROMs both pre- and postoperatively within each cohort, and between cohorts and rates of revision or reoperation. Results: The preoperative and postoperative PROMs between patients in the isolated cohort and the triad cohort demonstrated no significant differences, except for the Physical category of the VR-12, in which the triad cohort had significantly higher results (p = 0.04) (Figure 1). Both the isolated cohort and the triad cohort reported significant differences between pre- and postoperative PROMs within their own cohorts. When comparing methods of surgery, including all-inside vs. inside-out for the medial meniscus repairs and tunnel versus no-tunnel for the lateral meniscus root repairs, no significant differences were found between postoperative PROMs. Additionally, no significant difference was found in revision or reoperative rates between the triad and isolated cohorts (p = 0.374) (Figure 2), the all-inside versus inside-out medial meniscus cohorts (p = 0.267), or the tunnel vs. no-tunnel lateral meniscus cohorts (p = 0.781). Conclusions: There was no significant difference in PROMs between isolated ACLR versus ACLR with concomitant medial meniscus ramp and lateral meniscus root repairs. While the complexity of the TT ACLR patients was more involved, PROMs and healing rates were similar and performing concurrent medial ramp and lateral root repairs at the time of ACLR should be considered.

AbstractPurposeThe present study reviews the available scientific literature on artificial intelligence (AI)‐assisted ultrasound‐guided regional anaesthesia (UGRA) and evaluates the reported intraprocedural parameters and postprocedural outcomes.MethodsA literature search was performed on 19 September 2023, using the Medline, EMBASE, CINAHL, Cochrane Library and Google Scholar databases by experts in electronic searching. All study designs were considered with no restrictions regarding patient characteristics or cohort size. Outcomes assessed included the accuracy of AI‐model tracking, success at the first attempt, differences in outcomes between AI‐assisted and unassisted UGRA, operator feedback and case‐report data.ResultsA joint adaptive median binary pattern (JAMBP) has been applied to improve the tracking procedure, while a particle filter (PF) is involved in feature extraction. JAMBP combined with PF was most accurate on all images for landmark identification, with accuracy scores of 0.83, 0.93 and 0.93 on original, preprocessed and filtered images, respectively. Evaluation of first‐attempt success of spinal needle insertion revealed first‐attempt success in most patients. When comparing AI application versus UGRA alone, a significant statistical difference (p < 0.05) was found for correct block view, correct structure identification and decrease in mean injection time, needle track adjustments and bone encounters in favour of having AI assistance. Assessment of operator feedback revealed that expert and nonexpert operator feedback was overall positive.ConclusionAI appears promising to enhance UGRA as well as to positively influence operator training. AI application of UGRA may improve the identification of anatomical structures and provide guidance for needle placement, reducing the risk of complications and improving patient outcomes.Level of EvidenceLevel IV.

Abstract Background The legal climate for cannabis use has dramatically changed with an increasing number of states passing legislation legalizing access for medical and recreational use. Among cancer patients, cannabis is often used to ameliorate adverse effects of cancer treatment. Data are limited on the extent and type of use among cancer patients during treatment and the perceived benefits and harms. This multicenter survey was conducted to assess the use of cannabis among cancer patients residing in states with varied legal access to cannabis. Methods A total of 12 NCI-Designated Cancer Centers, across states with varied cannabis-access legal status, conducted surveys with a core questionnaire to assess cannabis use among recently diagnosed cancer patients. Data were collected between September 2021 and August 2023 and pooled across 12 cancer centers. Frequencies and 95% confidence intervals for core survey measures were calculated, and weighted estimates are presented for the 10 sites that drew probability samples. Results Overall reported cannabis use since cancer diagnosis among survey respondents was 32.9% (weighted), which varied slightly by state legalization status. The most common perceived benefits of use were for pain, sleep, stress and anxiety, and treatment side effects. Reported perceived risks were less common and included inability to drive, difficulty concentrating, lung damage, addiction, and impact on employment. A majority reported feeling comfortable speaking to health-care providers though, overall, only 21.5% reported having done so. Among those who used cannabis since diagnosis, the most common modes were eating in food, smoking, and pills or tinctures, and the most common reasons were for sleep disturbance, followed by pain and stress and anxiety with 60%-68% reporting improved symptoms with use. Conclusion This geographically diverse survey demonstrates that patients use cannabis regardless of its legal status. Addressing knowledge gaps concerning benefits and harms of cannabis use during cancer treatment is critical to enhance patient-provider communication.

Abstract Although the 2022 European LeukemiaNet (ELN) acute myeloid leukemia (AML) risk classification reliably predicts outcomes in younger patients treated with intensive chemotherapy, it is unclear whether it applies to adults ≥60 years treated with lower-intensity treatment (LIT). We aimed to test the prognostic impact of ELN risk in patients with newly diagnosed (ND) AML aged ≥60 years given LIT and to further refine risk stratification for these patients. A total of 595 patients were included: 11% had favorable-, 11% intermediate-, and 78% had adverse-risk AML. ELN risk was prognostic for overall survival (OS) (P &lt; .001) but did not stratify favorable- from intermediate-risk (P = .71). Within adverse-risk AML, the impact of additional molecular abnormalities was further evaluated. Multivariable analysis was performed on a training set (n = 316) and identified IDH2 mutation as an independent favorable prognostic factor, and KRAS, MLL2, and TP53 mutations as unfavorable (P &lt; .05). A “mutation score” was calculated for each combination of these mutations, assigning adverse-risk patients to 2 risk groups: −1 to 0 points (“Beat-AML intermediate”) vs 1+ points (“Beat-AML adverse”). In the final refined risk classification, ELN favorable- and intermediate-risk were combined into a newly defined “Beat-AML favorable-risk” group, in addition to mutation scoring within the ELN adverse-risk group. This approach redefines risk for older patients with ND AML and proposes refined Beat-AML risk groups with improved discrimination for OS (2-year OS, 48% vs 33% vs 11%, respectively; P &lt; .001), providing patients and providers additional information for treatment decision-making.