Retrospective Chart Review Study Research Articles

Evaluation of the effect of voxelotor and darbepoetin alfa on hemoglobin levels in patients with sickle cell disease.

To date, there is limited evidence on patients utilizing both voxelotor and darbepoetin alfa and its impact on hemoglobin levels. The objective is to evaluate the effect of voxelotor and darbepoetin alfa on hemoglobin levels in patients with SCD. This was a retrospective chart review study that assessed the primary independent variable as the utilization of either voxelotor alone, darbepoetin alfa alone, or the concurrent administration of voxelotor and darbepoetin alfa. Descriptive statistics were utilized to obtain the mean standard deviation for numerical variables and proportions for categorical variables. A total of 23 participants were included in this study. When comparing baseline to 2 months and 3 months, participants on voxelotor alone experienced a 3% decrease and a 6.6% increase in hemoglobin, darbepoetin alfa alone group a 4.3% decrease and a 0.6% increase in hemoglobin and voxelotor and darbepoetin group a 4.4% decrease and a 0.5% decrease in hemoglobin levels. Fifty percent of the participants in the voxelotor group and 6 (66.7%) participants in the voxelotor plus darbepoetin alfa group experienced adverse drug events. Voxelotor resulted in a clinically significant difference in the percent change of hemoglobin from baseline to 3 months.

Prediction of the small aperture intraocular lens on visual acuity in patients with keratoconus.

To investigate the impact of corneal higher-order aberrations (HOAs) on predicted corrected distance visual acuity (CDVA) in patients with keratoconus at varying simulated pupil apertures. Ophthalmology clinics, Medical University of South Carolina, USA. Retrospective chart review study. 56 eyes with keratoconus were examined using Scheimpflug tomography during routine examinations prior to medical intervention. The severity of keratoconus was graded using the Amsler-Krumeich classification. Zernike analysis was used to obtain corneal aberrations using simulated pupil diameters of 6-, 4-, and 2 mm. These data were extrapolated to obtain the total RMS HOAs for a 1.6 mm simulated pupil to evaluate the potential effect of a small aperture intraocular lens. Correlation analysis was used to study the impact and relative contributions of HOAs on CDVA. Convolution of HOAs from OPD-Scan III (NIDEK) provided a clinical method to predict CDVA with different simulated pupil sizes in corneas with irregular astigmatism. There were statistically significant positive correlations between photopic CDVA and the magnitude of total and individual (coma, spherical aberration and trefoil) HOAs in this cohort of keratoconus subjects. A keratoconus case with the small aperture IOL confirms the improvement in vision due to the pinhole effect. The small aperture IOL is expected to markedly reduce aberrations in keratoconus patients up to Amsler-Krumeich class 4 severity to levels consistent with the levels seen in healthy patients. Convolution of corneal HO aberrations with the ETDRS chart provides a useful simulation of the impact of pinhole optics in aberrated eyes.

Comparative analysis of tabelecleucel and current treatment in patients with Epstein-Barr virus-positive post-transplant lymphoproliferative disease following hematopoietic cell transplant or solid organ transplant

Aims: With recent European Union marketing authorization, tabelecleucel is the first off-the-shelf, allogeneic Epstein-Barr virus (EBV)-specific T-cell immunotherapy approved for the treatment of relapsed/refractory EBV-positive post-transplant lymphoproliferative disease (EBV+ PTLD). In the absence of a control arm, real-world evidence can provide a comparative benchmark for single-arm studies in ultra-rare populations. This study assessed the treatment effect of tabelecleucel in the single-arm phase 3 ALLELE study (NCT03394365) versus a treatment group from a multinational, multicenter retrospective chart review study (RS002) of patients with EBV+ PTLD. Methods: In ALLELE, patients had disease relapsed/refractory to rituximab ± chemotherapy and received tabelecleucel 2x106 cells/kg on days 1, 8, and 15 in 35-day cycles. Patients in RS002 had disease relapsed/refractory to rituximab ± chemotherapy and received next line of systemic therapy between January 2000 and December 2018. Propensity score-based standardized mortality/morbidity ratio weighting was used to achieve balance between treatment and comparator arms. Kaplan-Meier estimators and Cox regression models were used to compare overall survival (OS) in the re-weighted sample. Results: 30 patients (n = 14 hematopoietic cell transplant [HCT], n = 16 solid organ transplant [SOT]) from ALLELE (data cutoff: November 2021) and 84 patients (n = 36 HCT, n = 48 SOT) from RS002 (data lock: January 2021) were included. Median time from diagnosis to first tabelecleucel dose (ALLELE) or start date of next line of systemic therapy (RS002) was 3.6 months. Tabelecleucel was associated with a substantial OS benefit compared with current treatment, with an unadjusted HR of 0.47 (95% CI 0.25–0.88) and adjusted HR of 0.37 (95% CI 0.20–0.71) when using the start date of the next line of therapy as the index date. Sensitivity analyses yielded consistent results. Conclusions: In this study of real-world data, tabelecleucel was associated with an OS benefit among patients with R/R EBV+ PTLD for whom there is high unmet need.

SPIRIT: Assessing Clinical Parameters Associated with Using IDegLira in Patients with Type 2 Diabetes in a Real-World Setting in Colombia.

Insulin degludec/liraglutide (IDegLira) is a fixed-ratio combination of insulin degludec (a basal insulin) and liraglutide (a glucagon-like peptide-1 receptor agonist [GLP-1RA]). This study aimed to investigate clinical outcomes in people with type 2 diabetes mellitus (T2DM) after initiating IDegLira treatment in a real-world setting in Colombia. SPIRIT is a non-interventional, single-arm, retrospective chart review study to assess clinical outcomes in people with T2DM. Participating patients were switched from a treatment regimen of basal insulin (with or without oral antidiabetics [OADs]) and started on treatment with IDegLira a minimum of 26 ± 6weeks before the data collection start date. Data were collected from the medical records of 175 patients in ten clinical centers across Colombia. Compared with baseline, there was a significant reduction in glycated hemoglobin (HbA1c) (1.3%; 95% confidence interval [CI] -1.6 to -1.0; p < 0.0001) after 26 ± 6weeks of follow-up. The mean HbA1c at baseline and at the end of the study was 9.1% and 7.8%, respectively. In addition, IDegLira significantly reduced absolute body weight by 1kg (95% CI -1.5 to -0.5; p < 0.0001), from a mean of 76.1kg at baseline to 75.1kg after follow-up. The mean IDegLira dose at the end of the study was 21.3 U, and no severe hypoglycemic events were observed during the follow-up period. In real-world practice, initiating IDegLira in patients with T2DM previously treated with basal insulin (± OAD) was associated with improved glycemic control, reduced body weight and reduced risk of hypoglycemia. ClinicalTrials.gov identifier: NCT05324462.

Anticytokine Therapy and Corticosteroids for Cytokine Release Syndrome and for Neurotoxicity Following T-Cell Engager or CAR T-Cell Therapy

What Is the Issue? Cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) are the most common toxicities secondary to T-cell engager or chimeric antigen receptor (CAR) T-cell therapy. The US FDA and Health Canada approved tocilizumab, an anti-interleukin-6 receptor antagonist, for the management of severe or life-threatening cases of CRS. Corticosteroids also play an important role in CRS management and are the mainstay of ICANS management. Decision-makers are interested in understanding the use of anticytokine drugs (i.e., tocilizumab, anakinra, siltuximab) and/or corticosteroids in the management of CRS and ICANS following T-cell engager or CAR T-cell therapy. What Did We Do? We identified and summarized the literature comparing the clinical effectiveness and safety of anticytokine therapy and/or corticosteroids with alternative care or treatment as usual for treating and preventing of CRS and ICANS. We also searched for evidence-based recommendations for the use of anticytokine therapy and/or corticosteroids to treat and prevent CRS and ICANS. A research information specialist conducted a literature search of peer-reviewed and grey literature sources published between January 1, 2019 and February 26, 2024 for CRS; and between January 1, 2019 and March 4, 2024 for ICANS. One reviewer screened citations for inclusion based on predefined criteria, critically appraised the included studies, and narratively summarized the findings. What Did We Find? This report presents evidence-based findings on 3 retrospective chart review studies, 2 prospective cohort studies, and 4 consensus guidelines. Limited and low-quality clinical evidence from studies with a high risk of bias suggested that early use of tocilizumab or corticosteroids, or prophylactic use of tocilizumab or anakinra may reduce the risk of a high-grade CRS without a negative impact on neurotoxicity or immunotherapy treatment outcomes. The included guidelines recommend the use of tocilizumab for treatment of higher-grade CRS, or for treatment of grade 1 CRS if symptoms persist for 3 days or more. Corticosteroids could be added in conjunction if there is no improvement or persistent symptoms after tocilizumab therapy. For the management of ICANS in the absence of concurrent CRS, supportive care is the preferred treatment option for grade 1 ICANS, while corticosteroids are recommended for the management of grade 2 to 4 ICANS. In the presence of concurrent CRS, guidelines recommend tocilizumab therapy as per management of CRS, and corticosteroids should be continued until improvement to grade 1. We did not identify any clinical evidence regarding the clinical efficacy and safety of anticytokine therapy and/or corticosteroids for treatment of CRS and ICANS compared with alternative treatment or treatment as usual. We also did not identify any guidelines for the use of prophylactic anticytokine therapy, corticosteroids, or both for the prevention of CRS and ICANS. What Does This Mean? Despite limited and low-quality evidence, the findings suggest some potential benefits of prophylactic or early use of anticytokine therapy and corticosteroids for the management of immunotherapy-related toxicities. Guidelines offer guidance on the management of CRS, ICANS and other less common toxicities related to immunotherapy based on the available low-quality evidence. When using the clinical evidence and recommendations summarized in this report to inform decisions, decision-makers should consider that the evidence is limited and of low quality. To improve the certainty of findings, there is a need for more robust prospective clinical trials with larger sample sizes, and lower risk of bias.

Abstract PO2-04-04: Trastuzumab deruxtecan for the treatment of patients with HER2-positive breast cancer with brain and/or leptomeningeal metastases: an updated overall survival analysis using data from a multicenter retrospective study (ROSET-BM)

Abstract Background: ROSET-BM (UMIN000044995) was a multicenter, retrospective chart review study of patients (pts) who received trastuzumab deruxtecan (T-DXd) treatment for HER2-positive (HER2+) metastatic breast cancer (MBC) with brain metastases (BM) and/or leptomeningeal carcinomatosis (LMC). Primary results (data cutoff, October 31, 2021) were presented at SABCS2022 (median progression-free survival [PFS], 16.1 months; 1-year overall survival [OS] rate, 74.9%; and median follow-up duration, 11.2 months). To confirm the long-term effectiveness of T-DXd in HER2+ MBC pts with BM and/or LMC, we conducted an updated analysis using additional 1-year follow-up data. Methods: Pts who started T-DXd treatment between May 25, 2020, and April 30, 2021, were registered for ROSET-BM. For this updated OS analysis, the extended observation period ended on October 31, 2022. OS, PFS, and time to treatment failure (TTF) were evaluated. Median survival times and 95% CIs were calculated using the Kaplan–Meier method. In addition, prespecified and exploratory subgroup analyses were performed based on patient background characteristics. Univariate and multivariate Cox proportional hazards regression models were used to evaluate baseline prognostic factors for OS. Results: 104 pts from 62 institutions were included in this updated OS analysis. Median duration of follow-up was 20.4 months. Median number of prior lines of therapy was 4 (range, 1–15). Median time from first diagnosis of MBC to first administration of T-DXd was 37.5 months. Median time from first diagnosis of BM to first administration of T-DXd was 18.9 months. The prevalence of active BM, stable BM, LMC, and unclassified (image not evaluated) was 64.4% (n=67), 11.5% (n=12), 18.3% (n=19), and 5.8% (n=6), respectively. Median OS was not reached (NR) among all pts (1-year OS rate, 74.8%; 2-year OS rate, 56.0%). Subgroup analyses showed that median OS in pts with active BM was 27.0 months (95% CI, 16.4 to NR) and that median OS was NR in pts with stable BM or LMC (2-year OS rate for pts with stable BM, 71.6%; 2-year OS rate for pts with LMC, 61.6%). The results of univariate and multivariate analyses for OS showed no relevant baseline prognostic factors. Among all pts, median PFS was 14.6 months (95% CI, 10.6–20.8). Subgroup analyses showed that in pts with active BM, stable BM, and LMC, median PFS was 13.2 months (95% CI, 10.0–20.3), NR (95% CI, 5.3 to NR), and 17.5 months (95% CI, 8.3–22.1), respectively. Among all pts, median TTF was 9.3 months (95% CI, 6.3–11.8). The most common event and adverse event leading to discontinuation of T-DXd was progressive disease (37 pts, 35.6%) and interstitial lung disease (ILD; 24 pts, 23.1%), respectively. Median time to onset of an ILD event was 5.3 months (range, 0.7–20.0). ILD was grade 1 in 14 pts (13.5%), grade 2 in 3 pts (2.9%), grade 3 in 5 pts (4.8%), grade 4 in 2 pts (1.9%), and grade 5 in 0 pts. The Table summarizes the primary and updated results of ROSET-BM. Conclusion: The updated OS results of this retrospective chart review show that T-DXd has promising effectiveness in HER2+ MBC pts with long-term and heavily pretreated BM and LMC. This study was funded by Daiichi Sankyo Co., Ltd. Primary and updated results from the ROSET-BM study The updated results show that T-DXd has promising effectiveness in HER2+ MBC pts with long-term and heavily pretreated BM and LMC. Citation Format: Takashi Yamanaka, Naoki Niikura, Takahiro Nakayama, Mitsugu Yamamoto, Kazuo Matsuura, Kenichi Inoue, Sachiko Takahara, Hironori Nomura, Shosuke Kita, Miki Yamaguchi, Tomoyuki Aruga, Nobuhiro Shibata, Akihiko Shimomura, Yuri Ozaki, Shuji Sakai, Daisuke Takiguchi, Takehiko Takata, Armin Bastanfard, Kazuhito Shiosakai, Junji Tsurutani. Trastuzumab deruxtecan for the treatment of patients with HER2-positive breast cancer with brain and/or leptomeningeal metastases: an updated overall survival analysis using data from a multicenter retrospective study (ROSET-BM) [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO2-04-04.

Metal implant allergy: A retrospective cohort analysis at a university allergy practice.

Background: Concern of metal sensitization in pre- and postsurgical evaluation is growing, with the recent guidelines remaining the criterion standard for consideration of patch testing. Information remains scarce on surgical screening in the groups of patients who reported a history of metal sensitivity versus those with no reported history. Objective: The objective of this study was to assess the utility of patch testing in surgical candidates based on reported metal allergy history. The secondary objective was to evaluate the utility and outcomes in postsurgical patch testing. Methods: Nine hundred and thirty-one patient charts of patients with the diagnosis of "contact dermatitis" who underwent an evaluation at a single allergy clinic site between January 2013 and December 2022 were identified and reviewed as part of a retrospective chart review study. Patients were included in subgroups based on the time of patch testing and history of reported metal allergy. Results: In all, 67 patients underwent patch testing, 10 (14.9%) of whom were surgical candidates without a history of metal sensitivity, 31 (46.2%) of whom were surgical candidates with a history of metal sensitivity, and 26 (38.8%) of whom were postsurgical patients. Twenty-nine (43.3%) of patients had positive patch testing results, with only one (10%) in the presurgical group, 17 (54.8%) in the presurgical with a history of metal sensitivity, and 11 (42.3%) in the postsurgical group. Zero patients in our cohort without metal sensitivity who were undergoing the Nuss procedure had positive reactions on patch testing, whereas two of four (50%) with reported metal sensitivity who were undergoing the Nuss procedure had positive relevant metal reactions. Conclusion: Ambiguity in the utility of patch testing for surgical decision making remains, despite common utilization. Recent guidelines along with coordination of care among the surgeon, allergist, and patient remains the criterion standard of care.

Association between the thickness or area of the temporal muscle and skeletal muscle mass in bioimpedance analysis.

Introduction Sarcopenia associated with stroke can significantly impact patient prognosis; however, the current standard diagnostic methods for sarcopenia are rarely used in stroke patients. Therefore, the aim of the current study was to investigate whether the temporal muscle thickness (TMT) or area (TMA) could serve as a surrogate marker for measuring skeletal muscle mass. Methods This retrospective chart review study was conducted on 244 participants from March 2018 to February 2020. The TMT and TMA were measured at the supraorbital roof level using brain CT or T1-weighted MR imaging obtained from participants. The skeletal muscle mass and skeletal muscle index (SMI) and whole-body phase angle (WBPA) at 50 kHz were collected. Pearson correlation analysis was used to assess the relationship between the TMT or TMA and results of the bioimpedance analysis. Results The mean TMT showed significant positive correlations with skeletal muscle mass (male, r = 0.520; female, r = 0.706), SMI (male, r = 0.426; female, r = 0.582), and WBPA (male, r = 0.295; female, r = 0.232). The mean TMA showed significant positive correlations with skeletal muscle mass (male, r = 0.490; female, r = 0.657), SMI (male, r = 0.289; female, r = 0.473), and WBPA (male, r = 0.232; female, r = 0.243). Conclusions We observed moderate to strong positive correlations between body composition analysis measured by BIA and TMT or TMA, suggesting that TMT or TMA could serve as a reliable surrogate marker for identifying low skeletal muscle mass in cerebrovascular disease.

Safety and oncological outcome of early intraoperative intravesicle mitomycin C vs. deferred instillation in patients receiving robot-assisted radical nephroureterectomy.

Radical nephroureterectomy with concurrent bladder cuff excision (RNUBCE) is the gold standard surgical approach for high-risk primary upper tract urothelial carcinoma (UTUC). Given the notably high incidence of bladder tumor recurrence following this procedure, this study aimed to evaluate the effect and safety of intraoperative mitomycin-C (MMC) instillation vs. deferred instillation on overall oncological outcomes following robot-assisted RNUBCE. This is a retrospective chart review study. Patients with non-invasive (N0, not T3/T4) UTUC who underwent robotic RNUBCE combined an intraoperative MMC instillation or a deferred MMC instillation after surgery at a medical center in Taiwan between November 2013 and June 2020 were eligible for inclusion. Patients with prior bladder UC, carcinomas of other origins, received neoadjuvant chemotherapy, and had undergone kidney transplantation were excluded. All surgeries were executed by a single surgical team under the guidance of the same surgeon. The primary outcomes was the risk of bladder tumor recurrence between patients received intraoperative (IO) vs. deferred MMC instillation postoperatively (PO) during one-year follow-up. The secondary outcome was postoperative adverse events assessed by the Clavien-Dindo classification. Univariate and multivariable Cox regression analyses were performed to determine the associations between study variables and the outcomes. A total of 54 patients were included in the analysis. 12 (22.2%) patients experienced a bladder tumor recurrence during follow-up (IO: 7.7%, PO: 35.7%, p < 0.021). After adjustment in the multivariable, intraoperative MMC instillation was significantly associated with lower risk of bladder recurrence [adjusted hazard ratio (aHR) = 0.15, 95% CI: 0.03-0.81, p = 0.028]. No MMC-related Clavien-Dindo Grade III-IV adverse events were found in either group. IIntraoperative MMC instillation is safe and associated with a lower bladder tumor recurrence risk in patients undergoing robotic RNUBCE for UTUC than deferred instillation. Future large, prospective studies are still warranted to confirm the findings.

Real-world prevalence of microsatellite instability testing and related status in women with advanced endometrial cancer in Europe.

To assess the real-world prevalence of microsatellite instability (MSI)/mismatch repair (MMR) testing and related tumor status in recurrent/advanced endometrial cancer patients in Europe. Data were from two multi-center, retrospective patient chart review studies conducted in the United Kingdom, Germany, Italy, France and Spain: The Endometrial Cancer Health Outcomes-Europe-First-Line (ECHO-EU-1L) study and the ECHO-EU-Second-Line (ECHO-EU-2L) study. ECHO-EU-1L included recurrent/advanced endometrial cancer patients who received first-line systemic therapy between 1/JUN/2016 and 31/MAR/2020 after recurrent/advanced diagnosis. ECHO-EU-2L included patients with recurrent/advanced endometrial cancer who progressed between 1/JUN/2016 and 30/JUN/2019 following prior first-line systemic therapy. Data collected included patient demographics, MSI/MMR tumor testing and results, and clinical/treatment characteristics. ECHO-EU-1L included 242 first-line patients and ECHO-EU-2L included 475s-line patients. For all patients, median age at recurrent/advanced diagnosis was 69years, roughly half had endometrioid carcinoma histology and over 75% had Stage IIIB-IV disease at initial diagnosis. The prevalence of MSI/MMR testing in the first-line and second-line cohorts was similar (36.4 and 34.9%, respectively). Among those tested, a majority had non-MSI-high/MMR proficient tumors (80.7 and 74.7% among first- and second-line patients, respectively). About 15% had MSI-high/MMR deficient tumors in both cohorts, and a few patients had discordant results (3.4 and 10.8% among first- and second-line patients, respectively). Prior to the approvals of biomarker-directed therapies for recurrent/advanced endometrial cancer patients in Europe, there were low MSI/MMR testing rates for these patients of just over one-third. Given the availability of biomarker-directed therapies, increased MSI/MMR testing may help inform treatment decisions for recurrent/advanced endometrial cancer patients in Europe.

Efficacy of intentional undersized thoracic endovascular repair for Stanford type B aortic dissection

ObjectivesThoracic endovascular aneurysm repair (TEVAR) is widely used for the treatment of aortic dissection. Endograft oversizing is a risk factor for stent graft–induced new entry tears and retrograde type A aortic dissection. However, there is no clear consensus on the optimal graft size selection for Stanford type B acute or subacute aortic dissection (TBAD). Herein, we examined the safety and efficacy of TEVAR using an intentionally undersized endograft to treat TBAD. MethodsThis retrospective chart review study included 82 patients who underwent TEVAR for acute or subacute Stanford TBAD between 2015 and 2022. We measured the true lumen diameter just distal to the subclavian artery and opted for a stent graft of the same diameter. In instances where deformation resulting from false lumen pressure displacement was pronounced, we measured the diameter at the site just proximal to the subclavian artery. Patients’ characteristics, procedural, in-hospital, and follow-up data, and aortic remodeling were analyzed. The aortic diameter was analyzed using one-way analysis of variance followed by Dunnett’s test. Survival and freedom from re-intervention were estimated using Kaplan–Meier curves. ResultsThe follow-up rate was 98.4%. The mean age was 58.3 ± 12.3 years and 76 were men (92.7%). The mean diameters of the stent graft and native proximal landing zone were 30.9 ± 3.2 mm and 30.8 ± 3.0 mm, respectively. The oversize rate of the stent graft in relation to the native proximal aortic diameter was 0.3 ± 4.7%. In-hospital mortality was observed in one patient, retrograde type A aortic dissection in one patient, distal stent graft-induced new entry tear in zero patients, and type 1a endoleak in 22 patients (26.8%). Type 1a endoleaks, characterized by antegrade false lumen blood flow originating from the primary entry, in 12 patients spontaneously disappeared within 1 year of follow-up. According to aortic remodeling, 59 (86.8%) patients achieved complete aortic remodeling at the aortic arch level and 51 (75.0%) at the 8th thoracic vertebral level. The diameters of the aortic arch and descending aorta were significantly reduced compared with the postoperative measurements (P <0.001). Survival rates were 97.5% and 93.6% at 1 and 3 years, respectively. Freedom from re-intervention was 84.7% and 84.7% at 1 and 3 years, respectively. ConclusionsIntentionally undersized TEVAR was safe and achieved acceptable aortic remodeling despite a high rate of type 1a endoleaks. A type 1a endoleak was acceptable as it primarily diminished during the mid-term follow-up.

Achieving high inter-rater reliability in establishing data labels: a retrospective chart review study.

In medical research, the effectiveness of machine learning algorithms depends heavily on the accuracy of labeled data. This study aimed to assess inter-rater reliability (IRR) in a retrospective electronic medical chart review to create high quality labeled data on comorbidities and adverse events (AEs). Six registered nurses with diverse clinical backgrounds reviewed patient charts, extracted data on 20 predefined comorbidities and 18 AEs. All reviewers underwent four iterative rounds of training aimed to enhance accuracy and foster consensus. Periodic monitoring was conducted at the beginning, middle, and end of the testing phase to ensure data quality. Weighted Kappa coefficients were calculated with their associated 95% confidence intervals (CIs). Seventy patient charts were reviewed. The overall agreement, measured by Conger's Kappa, was 0.80 (95% CI: 0.78-0.82). IRR scores remained consistently high (ranging from 0.70 to 0.87) throughout each phase. Our study suggests the detailed manual for chart review and structured training regimen resulted in a consistently high level of agreement among our reviewers during the chart review process. This establishes a robust foundation for generating high-quality labeled data, thereby enhancing the potential for developing accurate machine learning algorithms.

Engagement in GI Behavioral Health Is Associated with Reduced Portal Messages, Phone Calls, and ED Visits.

Chronic digestive disorders are associated with increased costs for healthcare systems and often require provision of both urgent care and non-face-to-face (non-F2F) care, such as responding to patient messages. Numerous benefits of integrated gastroenterology (GI) behavioral health have been identified; however, it is unclear if integrated care impacts healthcare utilization, including urgent care and non-F2F contact. We sought to investigate the association between patient engagement with GI behavioral health and healthcare utilization. We performed a retrospective chart review study of adult patients who were referred for and completed at least one behavioral health appointment between January 1, 2019 and December 21, 2021 in the Gastroenterology and Hepatology department of a large academic medical center. Data on electronic medical record (EMR) messages, phone calls, and Emergency Department utilization were collected 6months before and 9months after patient engagement with GI behavioral health. 466 adult patients completed at least one behavioral health visit from 2019 to 2021. Overall, messages, phone calls, and ED visits all decreased significantly from the 6months before behavioral health treatment to 6months after (all P values < 0.001). Engagement with integrated GI behavioral health is associated with reduced non-F2F care and emergency department utilization in patients with chronic digestive disorders. Increasing access to GI behavioral health may result in reduced provider workload and healthcare system costs.

The Need for Standardized Nomenclature in Electronic Documentation of Female Genital Cutting in Health Records.

To evaluate the quality of Electronic Health Record (EHR) documentation practices of Female Genital Cutting (FGC) by medical providers. A retrospective chart review study of 99 patient encounter notes within the University of Minnesota health system (inclusive of 40 hospitals and clinics) was conducted. Extracted data included but was not limited to patient demographics, reason for patient visit, ICD code used in note, and provider description of FGC anatomy. Data was entered into REDCAP and categorized according to descriptive statistics. Out of 99 encounters, 45% used the unspecified code for FGC. The most common reason for patient visits was sexual pain, though many notes contained several reasons for the visit regarding reproductive, urological, or sexual concerns. 56% of visits discussed deinfibulation. 11 different terms for FGC were used, with "female circumcision" being the most common. 14 different terms for deinfibulation were found within 64 notes. 42% of encounters included a description of introitus size in the anatomical description, and only 38% of these provided a metric measurement. This study found significant variation in the quality of FGC documentation practices. Medical providers often used the unspecified FGC code, subjective and/or seemingly inaccurate descriptions of FGC/anatomy, and several different terms for both FGC and deinfibulation. Clearly, more education is needed in clinical training programs to (1) identify FGC type, (2) use the corresponding ICD code, and (3) use specific, objective descriptions (including presence/absence of structures and infibulation status).

Real-World Effectiveness of Dolutegravir/Lamivudine in People With HIV-1 in Test-and-Treat Settings or With High Baseline Viral Loads: TANDEM Study Subgroup Analyses.

Dolutegravir/lamivudine (DTG/3TC) was first approved by the US Food and Drug Administration in 2019 for the treatment of antiretroviral therapy (ART)-naive people with HIV-1 based on results from the pivotal GEMINI-1/GEMINI-2 trials. Around that time, immediate initiation of treatment upon diagnosis was recommended in the US Department of Health and Human Services guidelines. Here we report results from 126 treatment-naive people with HIV-1 who initiated DTG/3TC as part of a test-and-treat strategy (n = 61) or with high baseline viral loads (HIV-1 RNA ≥ 100,000 copies/ml; n = 16) from the TANDEM study. TANDEM was a US-based, retrospective chart review study that included a cohort of 126 individuals aged ≥ 18years with no prior history of ART who initiated DTG/3TC before September 30, 2020, and had ≥ 6months of follow-up. Test-and-treat was defined as ART initiation shortly after diagnosis without available viral load, CD4 + cell count, or HIV-1 resistance data. Outcomes included virologic suppression (HIV-1 RNA < 50 copies/ml; overall and by baseline viral load) and discontinuations. Analyses were descriptive. Among 61 individuals who initiated DTG/3TC in a test-and-treat setting (median [interquartile range (IQR)] treatment duration, 1.3 [0.9-1.7] years), 57 (93%) achieved virologic suppression, and 51 (84%) remained suppressed; 1 (< 1%) individual discontinued DTG/3TC due to persistent low-level viremia. The most common healthcare provider (HCP)-reported reason for initiating DTG/3TC was avoidance of long-term toxicities among individuals in the test-and-treat subgroup. Of 16 treatment-naive individuals with high baseline viral loads (median [IQR] treatment duration, 100,000-250,000 copies/ml: 1.2 [0.8-1.8] years; > 250,000 copies/ml: 1.0 [0.7-1.1] years), 14 (88%) achieved virologic suppression, 13 (81%) remained suppressed, and none discontinued DTG/3TC. Patient preference was the most common HCP-reported reason for initiating DTG/3TC in this subgroup. Results demonstrate real-world effectiveness of DTG/3TC, with few discontinuations, in people with HIV-1 in test-and-treat settings or with high baseline viral loads.

Hospital-Acquired Acute Kidney Injury in Non-Critical Medical Patients in a Developing Country Tertiary Hospital: Incidence and Predictors.

Acute kidney injury (AKI) is a frequent complication in critical patients, leading to a worse prognosis. Although its consequences are worse among critical patients, AKI is also associated with less favorable outcomes in non-critical patients. Therefore, understanding the magnitude of the problem in these patients is crucial, yet there is a scarcity of evidence in non-critical settings, especially in resource limited countries. Hence, the study aimed at determining the incidence and predictors of hospital acquired acute kidney injury (HAAKI) in non-critical medical patients who were admitted at a large tertiary hospital in Ethiopia. A retrospective chart review study was conducted from September 25, 2022 to January 20, 2023 among 232 hospitalized non-critical medical patients admitted to St. Paul's Hospital Millennium Medical College between January 2020 and January 2022. The incidence of HAAKI was estimated using incidence density per total person day (PD) observation of the study participants. To identify predictors of HAAKI, a log binomial regression model was fitted at a p value of ≤0.05. The magnitude of association was measured using adjusted relative risk (ARR) with its 95% CI. During the median follow-up duration of 11 days (IQR, 6-19 days), the incidence of HAAKI was estimated to be 6.0 per 100 PD (95% CI = 5.5 to 7.2). Significant predictors of HAAKI were found to be having type 2 diabetes mellitus (ARR = 2.36, 95% CI = 1.03, 5.39, p-value=0.042), and taking vancomycin (ARR = 3.04, 95% CI = 1.38, 6.72, p-value=0.006) and proton pump inhibitors (ARR = 3.80, 95% CI = 1.34,10.82, p-value=0.012). HAAKI is a common complication in hospitalized non-critical medical patients, and is associated with a common medical condition and commonly prescribed medications. Therefore, it is important to remain vigilant in the prevention and timely identification of these cases and to establish a system of rational prescribing habits.

Real-world treatment patterns and clinical outcomes from a retrospective chart review study of patients with recurrent or advanced endometrial cancer who progressed following prior systemic therapy in Europe

ObjectiveTo evaluate real-world treatment patterns and clinical outcomes in recurrent/advanced endometrial cancer patients who progressed following prior systemic therapy in clinical practice in Europe.DesignEndometrial Cancer Health Outcomes-Europe (ECHO-EU) is a...

Effect of Metabolic Syndrome and Metabolic Abnormalities on Remission of Bipolar Disorder Inpatients: A Retrospective Chart Review Study

Effect of Metabolic Syndrome and Metabolic Abnormalities on Remission of Bipolar Disorder Inpatients: A Retrospective Chart Review Study

Management of DOAC-related bleeding in cancer patients: a single center-case series.

Venous thromboembolism (VTE) and stroke carry significant mortality and morbidity in cancer patients. Direct oral anticoagulants (DOACs) have been demonstrated to be effective for the treatment of VTE and prevention of stroke in atrial fibrillation (AF). Bleeding rates are variable and are based on the cancer type and the patient's specific risk factors. There are approved specific antidotes for DOAC-associated bleeding. Other strategies are available for bleeding reversal, including the use of prothrombin complex concentrate (PCC). No randomized studies have compared head-to-head the efficacy and safety of reversal agents. We aim to examine the safety and effectiveness of hemostatic agents in cancer patients with DOAC-related major bleeding. A retrospective chart review study of patients at MD Anderson Cancer Center with DOAC-related major bleeding between 2014 and 2019. Bleeding severity and clinical hemostasis were described based on ISTH guidelines and the Sarode criteria, respectively. The rates of thrombotic complications and mortality at 30-day from the index bleeding event were described. We identified 23 patients with DOAC-related major bleeding; 14 patients received PCC and 9 patients received andexanet alfa. The most common sites of bleeding were the gastrointestinal tract and intracranial. Effective hemostasis and 30-day mortality were similar to reported results from other reports of outcomes of reversal agents for DOAC related-bleeding in non-cancer patients. One patient in each treatment group experienced a thrombotic event. Further larger scale studies are needed to confirm our findings in cancer patients.

Real-world Observational Multi-center Study: Retrospective Analysis of Diagnostic and Treatment Patterns for Stage III–IV Melanoma in Ukraine from 2018 to 2020

BACKGROUND: Despite open-access sources with information about cancer patients (National Cancer Registry of Ukraine), there are considerable gaps about actual diagnostic methods and specific treatment patterns or any details on how different regimens are applied for melanoma treatment in Ukraine. OBJECTIVES: This non-interventional, multicenter, retrospective medical chart review study aims to describe real-world therapeutic strategies and characterize the profile of patients with melanoma Stage III–IV in real-life clinical practice in Ukraine. METHODS: Anonymized data were collected from medical records of 747 patients in 9 oncology centers in Ukraine - four private and five public. The data variables were retrieved, captured in electronic case report forms, and analyzed with descriptive statistical methods. INCLUSION CRITERIA: Subjects were not enrolled unless they met all the following criteria: (1) Age &gt;18 years at the time of being diagnosed with III–IV stage melanoma. (2) Morphologically (including cytology) confirmed diagnosis of III–IV stage melanoma. Sufficient available medical records for data abstraction to meet the objectives of the study, that is, the patient has been under the medical care of the participating site for the entirety of the patient observation period or the patient’s detailed historical data on their disease course, and clinical management are otherwise available at the participating site consent has been granted by the Institutional Review Board/Ethical Committee of the study site. EXCLUSION CRITERIA: Subjects were not enrolled if they met any of the following criteria: (1) The patient has received treatment with anticancer systemic therapy for reasons other than melanoma. (2) Primary cancer other than melanoma. (3) The patient is participating (or was participating) in any investigational program/clinical trial with interventions outside of routine clinical practice. All the statistical tests were two sided and performed at a 0.05 significance level. p-values were rounded to three decimal places. p &lt; 0.001 were reported as &lt;0.001 in tables. RESULTS: Most melanoma cases (95.05%) were diagnosed histologically, although information about the primary tumor’s characteristics and treatment are heterogeneous. Most individuals (51.05%) diagnosed with Stage III undergo surgical treatment without additional therapy. Chemotherapy constitutes the primary form of systemic therapy for Stages III and IV, accounting for 33.3% and 45.65%, respectively. CONCLUSION: It is crucial to tackle the problems associated with diagnosing and treating melanoma in Ukraine. This involves creating a unified registry for melanoma patients, establishing uniform methods for staging and re-staging, and standardizing medical records. Nevertheless, the most critical issue is the absence of access to modern therapy, which should be addressed at the state level.