Standard Care Approach Research Articles

Uptake of Cancer Genetic Services for Chatbot vs Standard-of-Care Delivery Models: The BRIDGE Randomized Clinical Trial.

Increasing numbers of unaffected individuals could benefit from genetic evaluation for inherited cancer susceptibility. Automated conversational agents (ie, chatbots) are being developed for cancer genetics contexts; however, randomized comparisons with standard of care (SOC) are needed. To examine whether chatbot and SOC approaches are equivalent in completion of pretest cancer genetic services and genetic testing. This equivalence trial (Broadening the Reach, Impact, and Delivery of Genetic Services [BRIDGE] randomized clinical trial) was conducted between August 15, 2020, and August 31, 2023, at 2 US health care systems (University of Utah Health and NYU Langone Health). Participants were aged 25 to 60 years, had had a primary care visit in the previous 3 years, were eligible for cancer genetic evaluation, were English or Spanish speaking, had no prior cancer diagnosis other than nonmelanoma skin cancer, had no prior cancer genetic counseling or testing, and had an electronic patient portal account. Participants were randomized 1:1 at the patient level to the study groups at each site. In the chatbot intervention group, patients were invited in a patient portal outreach message to complete a pretest genetics education chat. In the enhanced SOC control group, patients were invited to complete an SOC pretest appointment with a certified genetic counselor. Primary outcomes were completion of pretest cancer genetic services (ie, pretest genetics education chat or pretest genetic counseling appointment) and completion of genetic testing. Equivalence hypothesis testing was used to compare the study groups. This study included 3073 patients (1554 in the chatbot group and 1519 in the enhanced SOC control group). Their mean (SD) age at outreach was 43.8 (9.9) years, and most (2233 of 3063 [72.9%]) were women. A total of 204 patients (7.3%) were Black, 317 (11.4%) were Latinx, and 2094 (75.0%) were White. The estimated percentage point difference for completion of pretest cancer genetic services between groups was 2.0 (95% CI, -1.1 to 5.0). The estimated percentage point difference for completion of genetic testing was -1.3 (95% CI, -3.7 to 1.1). Analyses suggested equivalence in the primary outcomes. The findings of the BRIDGE equivalence trial support the use of chatbot approaches to offer cancer genetic services. Chatbot tools can be a key component of sustainable and scalable population health management strategies to enhance access to cancer genetic services. ClinicalTrials.gov Identifier: NCT03985852.

The Impact of Enhanced Recovery Protocols Regarding Postoperative Nausea and Vomiting Following Sleeve Gastrectomy under Triple Prophylaxis: A Controlled Randomized Study

Background Following a sleeve gastrectomy, post-operative nausea and vomiting (PONV) is a typical issue. Furthermore, several prophylactic techniques have been developed, such as preventive antiemetic and accelerated recovery after surgery (ERAS). However, PONV has not entirely disappeared, and clinicians are still working to lower PONV incidence. Aim Our goal was to evaluate how adopting Enhanced Recovery Protocols (ERAS) affects postoperative nausea and vomiting (PONV) in comparison to standard care protocol after laparoscopic sleeve gastrectomy (LSG) while receiving triple antiemetic prophylaxis. Objective The objective of this study was to verify that the ERAS procedure is crucial for lowering PONV despite the use of an efficient and effective antiemetic. Methods This is a computer-generated randomized clinical trial. Haloperidol, dexamethasone, and ondansetron were administered to all patients undergoing elective LSG, 29 patients within an ERAS protocol, and 29 within a standard care protocol. The primary finding was the incidence of PONV within 36 hours following LSG. The time to initially administer rescue antiemetic medication, number of rescue antiemetic medication administrations, postoperative opioid consumption, oral fluid tolerance, complications, and QoR-15 questionnaire for quality of recovery were the secondary outcomes. Results Within the first 36 hours following LSG, the incidence of PONV in the ERAS group was 17.20%, while in the non-ERAS group, it was 51.7%, with P<0.012 and higher PONV severity (P<0.021) in the non-ERAS group. The ERAS group took a longer time (6 hours) for the first rescue antiemetic medicine than the Non-ERAS group (2 hours), with P<0.001 and significantly less number of patients (20.7%) needing rescue antiemetic, compared to the Non-ERAS group (65.5%), with P<0.001. The dosage of nalbuphine needed by the ERAS group was lower (2.7±2.8) than the non-ERAS group (19.9±6.0). Regarding the QoR-15 scores, there was a significant difference in the two groups' overall performance (P <0.001). Between the two groups, there were no significant complications following surgery. Conclusion This study reveals that even though triple antiemetic prophylaxis was used, the ERAS protocol had a beneficial effect on PONV when compared to the standard care approach.

Impact of Hepatitis B Virus Point-of-care DNA Viral Load Testing Compared With Laboratory-based Standard-of-care Approaches on Uptake of HBV Viral Load Testing, Treatment, and Turnaround Times: A Systematic Review and Meta-analysis.

Point-of-care (PoC) hepatitis B virus (HBV) DNA viral load (VL) assays represent an alternative to laboratory-based standard-of-care (SoC) VL assays to accelerate diagnosis and treatment. We evaluated the impact of using PoC versus SoC approaches on the uptake of VL testing, treatment, and turnaround times from testing to treatment across the HBV care cascade. We searched 5 databases, 6 conference websites, and contacted manufacturers for unpublished reports, for articles with or without a comparator (SoC VL testing), and had data on the uptake of VL testing, treatment, or turnaround times between hepatitis B surface antigen (HBsAg) testing, VL testing, and treatment in the cascade. We performed a random-effects meta-analysis on rates of VL testing and treatment initiation. Six studies, composing 9 arms, were included. Three PoC arms reported less than 1 day between screening for HBsAg positivity and VL testing, and the other one (2 arms) reported it between 7 and 11 days. Five arms reported the time to available VL test results (<1 day). Three studies reported 1-8 days between VL testing results and treatment initiation. Two studies reported the turnaround times between a positive HBsAg screening and treatment initiation (the same day and 27 days). Overall, 84.1% of those with HBsAg positivity were tested for DNA VL and 88.3% of eligible people initiated treatment. HBV PoC DNA testing appears to be associated with a turnaround time of <1 day for receipt of VL results and appears associated with high rates of DNA testing and initiation of treatment among those eligible. PROSPERO CRD42023398440.

Enhancing cognitive resilience: a narrative review of lifestyle interventions in cognitive decline prevention among older adults

Background: The increasing prevalence of cognitive decline and neurodegenerative disorders among ageing populations necessitates effective preventive strategies. Lifestyle interventions, including dietary modifications, cognitive training, and physical exercise, have emerged as promising avenues for enhancing cognitive resilience. This narrative review synthesizes current evidence on the efficacy of lifestyle interventions in preventing or delaying cognitive decline among older adults. Methods and Materials: A systematic search was conducted across databases, including PubMed and Google Scholar, using the PICO framework to formulate a precise research question. Inclusion criteria encompassed diverse study designs, focusing on older adults aged 65 years and above, diagnosed with mild cognitive impairment (MCI) or early-stage Alzheimer's disease (AD). Lifestyle interventions targeting cognitive health were compared against standard care or alternative non-pharmacological approaches, with primary outcomes including changes in cognitive function and activities of daily living (ADLs). Objectives: The review aimed to evaluate the effectiveness of lifestyle interventions, such as cognitive training, dietary modifications, and physical exercise, in preserving cognitive function and delaying cognitive decline among older adults. Results: The synthesis of evidence revealed significant benefits associated with lifestyle interventions. Dietary patterns rich in antioxidants, anti-inflammatory compounds, and essential fatty acids demonstrated neuroprotective effects and reduced cognitive decline risk. Physical exercise programs and cognitive stimulation interventions also showed promise in maintaining cognitive function. Multimodal approaches, personalized interventions, and long-term follow-ups emerged as key considerations for optimizing outcomes.

Systematic review of contemporary interventions for improving discharge support and transitions of care from the patient experience perspective.

To synthesize the impact of improvement interventions related to care coordination, discharge support and care transitions on patient experience measures. Systematic review. Searches were completed in six scientific databases, five specialty journals, and through snowballing. Eligibility included studies published in English (2015-2023) focused on improving care coordination, discharge support, or transitional care assessed by standardized patient experience measures as a primary outcome. Two independent reviewers made eligibility decisions and performed quality appraisals. Of 1240 papers initially screened, 16 were included. Seven studies focused on care coordination activities, including three randomized controlled trials [RCTs]. These studies used enhanced supports such as improvement coaching or tailoring for vulnerable populations within Patient-Centered Medical Homes or other primary care sites. Intervention effectiveness was mixed or neutral relative to standard or models of care or simpler supports (e.g., improvement tool). Eight studies, including three RCTs, focused on enhanced discharge support, including patient education (e.g., teach back) and telephone follow-up; mixed or neutral results on the patient experience were also found and with more substantive risks of bias. One pragmatic trial on a transitional care intervention, using a navigator support, found significant changes only for the subset of uninsured patients and in one patient experience outcome, and had challenges with implementation fidelity. Enhanced supports for improving care coordination, discharge education, and post-discharge follow-up had mixed or neutral effectiveness for improving the patient experience with care, compared to standard care or simpler improvement approaches. There is a need to advance the body of evidence on how to improve the patient experience with discharge support and transitional approaches.

Abstract 4889: Integrative multi-omic analysis reveals novel prognostic biological entities in pediatric medulloblastoma

Abstract Medulloblastoma is a cerebellar tumor for which relapses are associated with poor survival rates of less than 5%. Molecular heterogeneity and dose-limiting toxicities that occur with standard of care approaches, which include surgical resection, craniospinal irradiation, and chemotherapy, complicate the treatment of both primary and recurrent medulloblastoma due to adverse long-term sequela. While the integration of molecular analyses into the histopathology of pediatric medulloblastomas has changed the way these diseases are diagnosed, classified, and treated, there remains an unmet need to further understand the underpinnings of the disease to improve clinical outcomes and minimize neuronal, cognitive, and hormonal toxicities that occur with standard-of-care therapies. We therefore aimed to investigate novel subgroups of pediatric medulloblastoma as a basis for further defining biological properties and targets for the disease through multi-omic characterization. We derived single-nucleotide variant, copy number variant, expression, alternative splicing, and methylation array data from pediatric medulloblastomas profiled as part of the Children’s Brain Tumor Network (CBTN) and the Open Pediatric Cancer (OpenPedCan) projects. Using non-negative matrix factorization across the five datasets derived from genomic, transcriptomic, and epigenomic profiling, we identified 14 clusters found to be prognostically significant by Kaplan-Meier analysis of overall survival (p &amp;lt; 0.0001). Our model further subdivided sonic hedgehog (SHH) and Group 3/4 tumors, but not Wnt-driven tumors, suggesting that the latter forms a homogeneous molecular subgroup. Among our subgroups, we recapitulated the four classically defined medulloblastoma subtypes known to be associated with mutations in KDM6A, KMT2C, CTNNB1, PTCH1, TP53, KBTBD4, MYC, and MYCN. Cascading biological relationships across the copy number, methylation, and expression domains were observed among novel subgroups, potentially driving migratory, immuno-regulatory, GPCR-related, growth factor-related, and histone methylation biological programs. A comparison of subgroup expression profiles to transcriptional signatures from the Library of Integrated Network-Based Cellular Signatures (LINCS) program identified canonical oncogenic pathways unique to each subgroup as potentially targetable, including, but not limited to, MAPK, VEGFA, inflammatory, fatty acid metabolic, and PI3K/AKT signaling. Our work uncovers novel biological entities in pediatric medulloblastoma potentially driven by higher order mechanisms across the genome, transcriptome, and epigenome, with the possibility of informing novel precision medicine approaches for the disease. Citation Format: Komal Rathi, Varun Kesherwani, Ammar S. Naqvi, Yuankun Zhu, Alex Sickler, Xiaoyan Huang, Bo Zhang, Brian Rood, Adam C. Resnick, Adam A. Kraya. Integrative multi-omic analysis reveals novel prognostic biological entities in pediatric medulloblastoma [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2024; Part 1 (Regular Abstracts); 2024 Apr 5-10; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2024;84(6_Suppl):Abstract nr 4889.

Noninvasive imaging modalities in coronary artery disease: a meta analysis comparing coronary computed tomography angiography and standard of care.

Introduction: Coronary artery disease has become a global pandemic and a major cause of death. The risk-factor calculation for coronary artery damage is an invasive procedure. Aim: To compare coronary computed tomography angiography (CCTA) with standard of care (SOC) to calculate need for revascularization, invasive coronary angiography as well as for myocardial infarction (MI) incidence and all-cause mortality. Methodology, results &conclusion: CCTA is significantly correlated with a reduction in MI episodes (RR=0.752, 95% CI=0.578-1.409;p<0.033) and an increase in revascularizations (RR=1.401, 95% CI=1.315-1.492;p<0.001) and invasive coronary angiography procedures (RR=1.304, 95% CI=1.208-1.409;p<0.001). However, it was found that it did not affect all-cause mortality. On the contrary, standard care approaches were associated with greater rates of MI but lesser referrals for invasive coronary angiography and revascularization.

Long-Term Survival Analysis and Prognostic Factors of Arabic Patients with Differentiated Thyroid Carcinoma: A 20-Year Observational Study at the King Hussein Cancer Center (KHCC) Involving 528 Patients.

DTC accounts for the majority of endocrine tumors. While the incidence of thyroid cancer has been increasing globally over the past few decades, papillary thyroid carcinoma (PTC) generally shows an excellent prognosis, except in cases with aggressive clinicopathological features. This study aimed to assess the 5- and 10-year overall survival (OS) and progression-free survival (PFS) of 528 Arabic patients diagnosed with primary DTC from 1998 to 2021. Additionally, the study aimed to analyze the impact of various factors on both OS and PFS. An univariable survival analysis was conducted using Kaplan-Meier curves. The 5- and 10-year OS for patients with DTC have exceeded 95%. Additionally, PFS showed very good rates (ranging between 96.5 and 85% at 5 and 10 years, respectively). Age, male gender, risk of recurrence, and distant metastasis were identified as the main negative prognostic factors for both OS and PFS, while RAI treatment was found to be a significant factor in improving OS. Moreover, adherence to the King Hussein Cancer Center's (KHCC) CPG demonstrated significant improvement in PFS. These findings highlight common prognostic factors and favorable outcomes in Arabic patients with DTC treated at a tertiary cancer center using standard of care approaches.

Impact of hepatitis C virus point-of-care RNA viral load testing compared with laboratory-based testing on uptake of RNA testing and treatment, and turnaround times: a systematic review and meta-analysis

Point-of-care (POC) hepatitis C virus (HCV) RNA nucleic acid test viral load assays are being used increasingly as an alternative to centralised, laboratory-based standard-of-care (SOC) viral load assays to reduce loss to follow-up. We aimed to evaluate the impact of using POC compared with SOC approaches on uptake of HCV RNA viral load testing and treatment, and turnaround times from testing to treatment along the HCV care cascade. We searched PubMed, Embase, and Web of Science for studies published in English between Jan 1, 2016, and April 13, 2022. We additionally searched for accepted conference abstracts (2016-20) not identified in the main search. The contacts directory of the WHO Global Hepatitis Programme was also used to solicit additional studies on use of POC RNA assays. We included studies if they evaluated use of POC HCV RNA viral load with or without a comparator laboratory-based SOC assay, and had data on uptake of viral load testing and treatment, and turnaround times between these steps in cascade. We excluded studies with a sample size of ten or fewer participants. The POC studies were categorised according to whether the POC assay was based onsite at the clinic, in a mobile unit, or in a laboratory. Studies using the POC assay or comparator SOC assays were further stratified according to four models of care: whether HCV testing and treatment initiation were performed in the same or different site, and on the same or a different visit. The comparator was centralised, laboratory-based HCV RNA SOC assays. For turnaround times, we calculated the weighted median of medians with 95% CIs. We analysed viral load testing and treatment uptake using random-effects meta-analysis. The quality of evidence was rated using the GRADE framework. This study is registered with PROSPERO, CRD42020218239. We included 45 studies with 64 within-study arms: 28 studies were in people who inject drugs, were homeless, or both; four were in people incarcerated in prison; nine were in the general or mixed (ie, includes high-risk groups) populations; and four were in people living with HIV. All were observational studies. The pooled median turnaround times between HCV antibody test and treatment initiation was shorter with onsite POC assays (19 days [95% CI 14-53], ten arms) than with either laboratory-based POC assays (64 days [64-64], one arm) or laboratory-based SOC assays (67 days [50-67], two arms). Treatment uptake was higher with onsite POC assays (77% [95% CI 72-83], 34 arms) or mobile POC assays (81% [60-97], five arms) than with SOC assays (53% [31-75], 12 arms); onsite and mobile POC assay vs SOC assay p=0·029). For POC and SOC arms, higher RNA viral load testing uptake was seen with the same-site models for testing and treatment than with different-site models (all within-category p≤0·0001). For onsite and mobile POC arms, there was higher treatment uptake for same-site than different-site models (within-category p<0·0001). Four studies had direct within-study POC versus SOC comparisons for RNA viral load testing uptake (pooled relative risk 1·11 [95% CI 0·89-1·38]), and there were ten studies on treatment uptake (1·32 [1·06-1·64]). Overall, the quality of evidence was rated as low. Compared with use of laboratory-based SOC HCV viral load testing, the use of POC assays was associated with reduced time from antibody test to treatment initiation and increased treatment uptake. The effect of POC viral load testing is greatest when positioned within a simplified care model in which testing and treatment are provided at the same site, and, where possible, on the same day. POC HCV RNA viral load testing is now recommended in WHO guidelines as an alternative strategy to laboratory-based viral load testing. Unitaid.

Elevated HbA1c level associated with disease severity and surgical extension in diabetic foot patients.

Diabetic foot is a complex syndrome that is associated with other diabetic complications, such as peripheral arte-rial disease and peripheral neuropathy. Optimization of plasma glucose and glycated hemoglobin (HbA1c) is one of the main principles of standard care and treatment approaches in individuals with diabetes mellitus (DM). In this study, the relationship of HbA1c level at the time of diagnosis was evaluated with diabetic foot disease severity score and surgical extension in patients with Type 2 DM. This study included 301 consecutive patients who were diagnosed with diabetic foot in the general surgery diabetic foot clinic and were hospitalized for surgery. The relationships between the HbA1c levels of the patients with the Wagner and PEDIS (Perfusion, Extent, Dept, Infection, Sensation) classification system grades, and the surgical procedures performed were analyzed and the treatment outcomes were evaluated. It was determined that there was a 90% statistically significant relationship between HbA1c values of ≥10.1% and the de-velopment of Wagner Grade 4 diabetic foot ulcer (DFU) (P=0.037). A strong statistically significant relationship at the rate of 85% was determined between HbA1c values of ≥10.1% and the development of PEDIS Grade 3 ulcers. As the HbA1c values increased, so there was determined to be a statistically significant relationship with the development of PEDIS Grade 3 ulcer (P=0.003). In the comparison of the HbA1c values according to the type of surgery performed, a weak relationship was determined at the rate of 26%, and it was determined that as the HbA1c values increased, so there could be an increase in the amputation level. The results of this study showed that as HbA1c values at diagnosis increased in patients with diabetic foot; Wagner/PEDIS grades, disease severity, surgical extension, amputation level, and tissue loss increased. To reduce the severity of diabetic foot disease and prevent amputation, compliance with diabetic treatment and glycemic control should be increased.

Deadly suicidal attempt and burdensome airway management, challenges to anesthesiologist with exposed airway

Rationale: Showcasing this case report is of essential importance to shed the light on this rare situation propelling advancement in clinical rationale to detect and manage such cases. Patient Concerns: A 25-year-old male patient presented with suicidal injury by cutting his throat open using a knife due psychiatric history of depression. Diagnosis: Clear-cut injuries to the neck area present with significant impairment to the human body functions from breathing to vascular injuries that eventually will lead to obstructed airways and haemorrhagic shock later. Interventions: In this case, we stress on the essentialness of the multidisciplinary team to manage and treat such critical situations, and this underlines the involvement of the anaesthesiologist to protect the airways in such difficult situations and immediately shifting the patient to the operation theatre involving the otolaryngologist, vascular surgeon and postoperatively by intensivists and psychiatrists. As the patient was arrested in the accident and emergency department, it was not applicable to take the patient to any imaging modality and this even created more challenge for the team to exclude any further injuries and to treat according to the standard acute care approach. Outcomes: Improved physical and psychiatric status which helped the patient to return to pre-injury state after fatal suicidal attempt. Lessons: Here, we highlight the urgency and the importance of immediate action in protecting the airways while following the ABCDE guidelines in addition to the rapid intervention, while minimizing time for imaging and shifting of the patient in such critical situations. Importance of the multidisciplinary team involvement while harmonizing treatment to avoid relapse and failure.

Comparative Effectiveness of Combined IgM-Enriched Immunoglobulin and Extracorporeal Blood Purification Plus Standard Care Versus Standard Care for Sepsis and Septic Shock after Cardiac Surgery.

The combination of surgery, bacterial spread-out, and artificial cardiopulmonary bypass surfaces results in a release of key inflammatory mediators leading to an overshooting systemic hyper-inflammatory condition frequently associated with compromised hemodynamics and organ dysfunction. A promising approach could be extracorporeal blood purification therapies in combination with IgM enriched immunoglobulin. This approach might perform a balanced control of both hyper and hypo-inflammatory phases as an immune-modulating intervention. We performed a retrospective observational study of patients with proven infection after cardiac surgery between January 2020 and December 2021. Patients were divided into two groups: (1) the first group (Control Group) followed a standard care approach as recommended by the Surviving Sepsis Campaign Guidelines; The second group (Active Group) underwent extracorporeal blood purification therapy (EBPT) in combination with intravenous administration of IgM enriched immunoglobulin 5 mL/kg die for at least three consecutive days, in conjunction with the standard approach (SSC Guidelines). In addition, ventriculo-arterial (V/A) coupling, Interleukin 6 (IL-6), Endotoxin Activity Assay (EAA), Procalcitonin, White Blood Cells (WBC) counts, Sequential Organ Failure Assessment (SOFA) Score and Inotropic Score were assessed in both two groups at different time points. Fifty-four patients were recruited; 25 were in the Control Group, while 29 participants were in the Active Group. SOFA score significantly improved from baseline [12 (9-16)] until at [8 (3-13)] in the active group; it was associated with a median EAA reduction from 1.03 (0.39-1.20) at to 0.41 (0.2-0.9) at in the active group compared with control group 0.70 (0.50-1.00) at to 0.70 (0.50-1.00) at (p 0.001). V/A coupling tended to be lower in patients of the active arm ranging from 1.9 (1.2-2.7) at to 0.8 (0.8-2.2) at than in those of the control arm ranging from 2.1 (1.4-2.2) at T0 to 1.75 (1.45-2.1) at (p = 0.099). The hemodynamic improvement over time was associated with evident but no significant decrease in inotropic score in the active group compared with the control group. Changes in EAA value from to were directly and significantly related (r = 0.39, p = 0.006) to those of V/A coupling. EBPT, in combination with IgM enriched immunoglobulin, was associated with a mitigated postoperative response of key cytokines with a significant decrease in IL-6, Procalcitonin, and EAA and was associated with improvement of clinical and metabolic parameters.

Abstract 5897: Paired tumor/normal clinical sequencing enables identification of patients with pathogenic germline variants

Abstract Background: Genomic profiling through paired tumor/non-tumor analysis can identify pathogenic germline variants (PGV) responsible for inherited cancer syndromes. This can benefit patients and their relatives through cascade testing (CT), preventing many cancer-related deaths. We explored the impact of this strategy for tumor profiling on cancer syndrome diagnosis. Methods: The Tumor Profiling Lab (TPL) sequences cancer specimens and matched normal tissue using the Oncomine Comprehensive Assay (ThermoFisher). A protocol was implemented between the TPL and the Cancer Genetics and Prevention Program (CGPP) by which a notification was sent to oncologists and the CGPP when a PGV was identified. The notification highlights the finding and facilitates referral to CGPP. Our analysis includes data from 1/2018 to 7/2021. Primary outcome: identification of PGV. Secondary outcomes: patients referred and seen by CGPP, and advised for CT. Results: A total of 123 (6.35%) patients with over 20 cancer types had a PGV; for 85 (69.1%) this was a new finding. 36 of the 85 (42.4%) were referred to CGPP and of those, 24 (66.7%) were seen and advised for CT. 4 patients with newly diagnosed PGV had already been seen by CGPP, but either had not undergone genetic testing or had not been tested for the gene in which a PGV was later found. Of the 123 patients with PGV, 74 were not seen by CGPP. 33 (44%) were advised by their oncologist regarding CT for relatives. In total, among patients with newly diagnosed PGV, 51 (60%) were advised for CT. Conclusion: 2/3 of cancer patients in whom paired tumor/normal sequencing analysis identified a PGV had not been previously diagnosed with an inherited cancer syndrome by standard of care approaches. Identification of a PGV resulted in CT advice for 60% of these patients, with hundreds of family members potentially benefitting from preventive measures. Creating more streamlined systems for notifying relatives can result even in greater benefit by reaching more individuals. Baseline demographics Table 1 N = 123 Age at tumor testing, mean (range) 60.4 (10-90) Gender, n (%) Female 62 (50.4) Male 61 (49.6) Stage at tumor testing, n (%) Stage IV 103 (83.7) Stage I-III 20 (16.3) Known PGV, n (%) Known 38 (30.9) New 85 (69.1) Referral to CGPP, n (%) Referred 37 (30.1) Not Referred 61 (49.6) N/A (known to a cancer genetics program*) 25 (20.3) *22 known to CGPP; 3 known to outside programs Seen by CGPP, n (%) Seen 49 (39.8) Not Seen 74 (60.2) Days from referral to visit, median (range) 17 (1-217) Advised for CT (including seen by CGPP)**, n (%) Advised 81 (65.9) Not advised 42 (34.1) ** One patient seen before tumor testing; no identifiable mutation at that visit. After testing, new PGV found, but was not counseled on it. Advised for CT (if not seen by CGPP), n (%) N = 75 Advised 33 (44.0) Not advised 42 (56.0) Citation Format: Christina N. Dimopoulos, Karina Brierley, Joanna Gibson, Zenta Walther, Xavier Llor. Paired tumor/normal clinical sequencing enables identification of patients with pathogenic germline variants [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2022; 2022 Apr 8-13. Philadelphia (PA): AACR; Cancer Res 2022;82(12_Suppl):Abstract nr 5897.

Work Ability After Anterior Cervical Decompression and Fusion Followed by a Structured Postoperative Rehabilitation: Secondary Outcomes of a Prospective Randomized Controlled Multi-Centre Trial with a 2-year Follow-up

Purpose Information on work ability after ACDF and postoperative rehabilitation is lacking. The aim of the present study is therefore to investigate the work ability benefits of a structured postoperative treatment (SPT) over a standard care approach (SA) in patients who underwent anterior cervical decompression and fusion (ACDF) for cervical radiculopathy and factors important to the 2-year outcome. Methods Secondary outcome and prediction model of a prospective randomized controlled multi-centre study with a 2-year follow-up (clinicaltrials.gov NCT01547611). The Work Ability Index (WAI) and Work Ability Score (WAS) were measured at baseline and up to 2 years after ACDF in 154 patients of working age who underwent SPT or SA after surgery. Predictive factors for the WAI at 2 years were analysed. Results Both WAI and WAS significantly improved with SPT and SA (p < 0.001), without any between-group differences. Thoughts of being able to work within the next 6 months, Neck Disability Index (NDI), and work-related neck load explained 59% of the variance in WAI at the 2-year follow-up after ACDF. Conclusions Patients improved over time without group differences, suggesting the improvement to be surgery related. Expectation to work within the next 6 months, self-reported neck functioning and work-related neck load were important to work ability and are central factors to ask early after ACDF, to identifying further interventions promoting return to work.

Pomalidomide-Dexamethasone Effectiveness in t(11;14) Positive Relapsed Multiple Myeloma in Real-World Setting

Background: Treatment of multiple myeloma (MM) commonly encompasses combination of drugs within the three drug classes including proteasome inhibitors (PIs), immunomodulators and (IMiDs), and monoclonal antibodies, both for newly diagnosed and relapsed disease. With increasing appreciation of disease heterogeneity based on underlying genetic abnormality, and demonstration of efficacy of venetoclax in patients with t(11;14) MM, the outcomes with commonly used MM regimens among the different cytogenetic subgroups are of great interest. Venetoclax, a BCL-2 inhibitor, is being studied in t(11;14) positive MM patients who have received at least two prior lines of treatment (NCT03539744; CANOVA). However, outcomes in previously treated t(11;14) MM patients using standard of care approaches in the real-world setting is limited.Patients and methods: This non-interventional, retrospective observational cohort study included patients with t(11;14) MM from the International Myeloma Working Group (IMWG) retrospective study of t(11;14) MM. From the overall cohort, patients with t(11;14) MM receiving pomalidomide + dexamethasone (PomDex) in ≥3 rd line were selected, similar to those being enrolled in the ongoing CANOVA trial. Patients were also required to have prior exposure to lenalidomide and a PI without a history of transplant within 16 weeks prior to PomDex initiation. Patients enrolled in a clinical trial were excluded. Overall best response, time to next therapy (TTNT) as a surrogate measure for progression-free survival (PFS) and overall survival (OS) were assessed after initiation of PomDex. All analyses were descriptive in nature and were conducted using SAS 9.4 (SAS Institute Inc., Cary, NC, USA).Results: Fifty-two patients who met the inclusion criteria were analyzed. Median age was 63 years, 60% were male. Patients had a median of 3 prior lines at start of PomDex, at a median of 4.3 years from diagnosis; 52% had a prior transplant. A PR or better was observed in 34% of patients with PomDex. The median TTNT for this cohort was 6.1 months and median OS was 19.2 months.Conclusion: This retrospective study of non-trial patients with t(11;14) MM provides a benchmark for newer therapies in this patient population for comparison with both venetoclax dexamethasone in the ongoing CANOVA study as well as combinations using the pomalidomide backbone. DisclosuresKarve: AbbVie: Current Employment, Current equity holder in publicly-traded company. Kumar: Roche-Genentech: Consultancy, Research Funding; Bluebird Bio: Consultancy; Celgene: Membership on an entity's Board of Directors or advisory committees, Research Funding; Amgen: Consultancy, Research Funding; Novartis: Research Funding; Takeda: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Astra-Zeneca: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Merck: Research Funding; KITE: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Janssen: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Carsgen: Research Funding; Antengene: Consultancy, Honoraria; Oncopeptides: Consultancy; Beigene: Consultancy; Tenebio: Research Funding; BMS: Consultancy, Research Funding; Abbvie: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Adaptive: Membership on an entity's Board of Directors or advisory committees, Research Funding; Sanofi: Research Funding. Gonzalez De La Calle: Celgene-BMS, Janssen, Amgen: Honoraria. Mangiacavalli: GSK: Honoraria; Takeda: Honoraria; Janssen: Honoraria; BMS: Honoraria. Kastritis: Janssen: Consultancy, Honoraria, Research Funding; Takeda: Honoraria; Pfizer: Consultancy, Honoraria, Research Funding; Genesis Pharma: Honoraria; Amgen: Consultancy, Honoraria, Research Funding. Esteves: AbbVie: Consultancy; BMS: Consultancy; Amgen: Consultancy; Janssen: Consultancy. Delforge: Amgen: Honoraria, Membership on an entity's Board of Directors or advisory committees; Bristol Myers Squibb: Honoraria, Membership on an entity's Board of Directors or advisory committees. Yee: Karyopharm: Consultancy; Bristol Myers Squibb: Consultancy; Oncopeptides: Consultancy; Adaptive: Consultancy; GSK: Consultancy; Takeda: Consultancy; Amgen: Consultancy; Janssen: Consultancy; Sanofi: Consultancy. Arriola: AbbVie: Current Employment, Current holder of individual stocks in a privately-held company, Current holder of stock options in a privately-held company. Ross: AbbVie: Current Employment, Current equity holder in publicly-traded company, Current holder of individual stocks in a privately-held company. Manthena: AbbVie: Current Employment, Current holder of individual stocks in a privately-held company, Current holder of stock options in a privately-held company. Durie: Amgen, Celgene/Bristol-Myers Squibb, Janssen, and Takeda: Consultancy; Amgen: Other: fees from non-CME/CE services .

Challenges and opportunities during the COVID-19 pandemic: Treating patients for substance use disorders during the perinatal period

The coronavirus disease 2019 (COVID-19) pandemic exacerbated the opioid use disorder epidemic and accelerated alcohol and other substance use disorders. Sudden health care service delivery changes during the COVID-19 pandemic created both challenges and opportunities for all patients with substance use disorders including the use of virtual or telemedicine visits, medication access issues and ensuring access to naloxone when supplies cannot be handed out. Unique challenges for pregnant and post-partum patients with substance use disorders includes some evidence of reduced access to medication to treat opioid use disorders and changes in delivery protocols that isolate birthing people from supports. Opportunities for all patients with substance use disorders include virtual platforms presenting positive opportunities for treatment. They are time efficient, eliminate transportation barriers, and potentially reduce childcare barriers. For pregnant and post-partum patients with substance use disorders, hybrid models of telemedicine and in-person visits reduced no-show visit rates and increased flexibility in medication dosing regimens. Thus, there is a unique opportunity to study the success of different virtual care models given the variety of implemented strategies. The COVID-19 pandemic provides an unprecedented opportunity to dramatically transform standard care approaches to help optimize care for all patients, including pregnant and post-partum people.

Meta-analysis of minimalist versus standard care approach for transcatheter aortic valve replacement

ABSTRACT Background The change in practice of transcatheter aortic valve replacement (TAVR) to a minimalist approach is a debate. Methods Online database search for studies that compared the minimalist approach with the standard approach for TAVR were searched from inception through September 2020. We calculated pooled odds ratios (ORs) and 95% confidence intervals (CIs) using the fixed or random-effects model. Results A total of 9 studies with 2,880 TAVR patients (minimalist TAVR;1066 and standard TAVR; 1,814) were included. Compared to standard approach, there were no significant differences in in-hospital mortality, 30-day mortality, or hospital readmissions. However, there was a reduced risk of acute kidney injury (OR0.49;95%CI0.27–0.89), major bleeding (OR0.21;95%CI0.12–0.38) and major vascular complications (OR0.60,95%CI0.39–0.91) associated with the minimalist TAVR group. There was comparatively shorter hospital length of stay (mean difference −2.41;95%CI-2.99,-1.83) days, procedural time (mean difference −43.99;95%CI-67.25,-20.75) minutes, fluoroscopy time (mean difference −2.69;95%CI-3.44,-1.94) minutes and contrast volume (mean difference −26.98;95%CI-42.18,-11.79) ml in the minimalist TAVR group. Conclusions This meta-analysis demonstrated potential benefits of the minimalist TAVR approach over the standard approach regarding some adverse clinical outcomes as well as procedural outcomes without significant differences in mortality or readmission rates.

Assessment of feasibility and acceptability of family-centered care implemented at a neonatal intensive care unit in India

BackgroundA family-centered care (FCC) parent participation program that ensures an infant is not separated from parents against their will was developed for the caring of their small or sick newborn at a neonatal intensive care unit (NICU) in Delhi, India. Healthcare provider sensitization training directed at psychosocial and tangible support and an audio-visual training tool for parent-attendants were developed that included: 1) handwashing, infection prevention, protocol for entry; 2) developmentally supportive care, breastfeeding, expression of breastmilk and assisted feeding; 3) kangaroo mother care; and 4) preparation for discharge and care at home. The study aimed to examine the feasibility and acceptability of the FCC model in a NICU in India.MethodsA prospective cohort design collected quantitative data on each parent-attendant/infant dyad at enrollment, during the NICU stay, and at discharge. Feasibility of the FCC program was measured by assessing the participation of parent-attendants and healthcare providers, and whether training components were implemented as intended. Acceptability was measured by the proportion of parent-attendants who participated in the trainings and their ability to accurately complete program activities.ResultsOf 395 NICU admissions during the study period, eligible participants included 333 parent-attendant/infant dyads, 24 doctors, and 21 nurses. Of the 1242 planned parent-attendant training sessions, 939 (75.6%) were held, indicating that program fidelity was high, and the majority of trainings were implemented as intended. While 50% of parent-attendants completed all 4 FCC training sessions, 95% completed sessions 1 and 2; 60% of the total participating parent-attendants completed session 3, and 75% completed session 4. Compliance rates were over 96% for 5 of 10 FCC parent-attendant activities, and 60 to 78% for the remaining 5 activities.ConclusionsFCC was feasible to implement in this setting and was acceptable to participating parent-attendants and healthcare providers. Parents participated in trainings conducted by NICU providers and engaged in essential care to their infants in the NICU. A standard care approach and behavior norms for healthcare providers directed psychosocial and tangible support to parent-attendants so that a child is not separated from his or her parents against their will while receiving advanced care in the NICU.

A Group Videoconference Intervention for Reducing Perinatal Depressive Symptoms: A Telehealth Pilot Study.

Perinatal depression occurs in 12% to 18% of childbearing women. Telehealth is a promising platform for delivering perinatal mental health care, particularly during a pandemic when in-person services have been significantly curtailed. However, there is little research to document the feasibility of telehealth to address perinatal depression. This pilot study evaluated the feasibility and preliminary results of an 8-week facilitated group videoconference intervention. The study enrolled pregnant and postpartum women into an 8-week group mindfulness-based cognitive behavioral intervention, delivered via videoconference platform. Women receiving care at outpatient clinics who either screened positive for perinatal depression symptoms or had risk factors predictive of perinatal depression were invited to participate. Women attended weekly one-hour group sessions using their own electronic device and completed the Edinburgh Postnatal Depression Scale (EPDS) at several time points. Session attendance and survey completion rates were evaluated. A total of 47 women enrolled (8 postpartum; 39 prenatal) into groups of 4 to 6. Twenty-four (51.1%) women were currently experiencing mild to moderate perinatal depression symptoms (EPDS score of 10-20), whereas 23 (48.9%) women had EPDS scores less than 10 but were at high risk for developing perinatal depression due to health history and significant life events. Seventy percent of women attended at least 5 of the 8 sessions. Trajectories of EPDS measures were promising (ie, downward among those with current perinatal depression symptoms and stable among those at high risk for developing perinatal depression). These observational results are promising, suggesting further study of effectiveness for women with symptoms of perinatal depression, as well as for women at high risk for developing perinatal depression. Randomized trials could evaluate the effectiveness of the intervention, compared with standard of care approaches. Telehealth interventions can be tailored to meet the needs of different communities, and increase access to care, regardless of where women live or inability to receive in-person services.

Prognostic value of a normal Artificial Intelligence applicative response in subjects with stable chest pain. From the ARTICA co-operative registry

Abstract Background An innovative artificial intelligence (AI) Decision Support System (DSS) ESC guidelines based has already been used at point of care with efficacy for evaluating subjects with stable chest pain (SCP) and it has been proved to correctly identify absence of significant coronary artery disease (CAD) versus standard care approach (SD) without known prognostic implication yet. Purpose The aim is to determine the prognostic value of “no testing/Follow up” AI DSS response in a referral population evaluated for SCP. Methods From 2016 to 2019, an AI DSS ESC guidelines based applicative was used on 1.291 subjects with SCP to determine testing appropriateness compared with human specialist standard evaluation. 590 of them, 332 males, mean age 62±11 years deemed to be completely negative – by “no testing/follow up” response - were evaluated. The negative response was defined and confirmed by a normal Coronary Tomography Angiography scan executed in all these subjects. Mean follow-up was 3.46±1.76 years. Two groups based on pre-test likelihood of having CAD were analyzed – low and intermediate. No subjects with high pre-test likelihood were present. The primary endpoint was cumulative incidence of cardiovascular death, hospitalizations for acute coronary syndrome and coronary revascularizations. Results The primary endpoints classification is displayed in the Table. The unadjusted hazard ratio for primary endpoint was 3.84 (95% CI 0.32–8.68, p=0.009) in patients with intermediate compared to those with low pre-test likelihood of CAD. Moreover, the “no testing and Follow up” response showed an incremental prognostic value over conventional risk factors (χ2=7, P=0.022) and over a combination of conventional factors and ST-T changes (χ2=9, P=0.014). Conclusions In an outpatient population without known CAD evaluated for chest pain, after the administration of AI DSS, a “No tests/Follow up” confers an excellent prognosis regardless of the ESC SCORE Charts and rest ECG abnormalities. These preliminary data confirms the safety of ARTICA AI DSS use in subjects with stable chest pain. Funding Acknowledgement Type of funding source: None