Early Phase Of Treatment Research Articles

BIOM-25. MOLECULAR PROFILING PREDICTS EARLY AND LATE PROGRESSION IN GLIOBLASTOMA

Abstract Patients with glioblastoma experience a wide variation in response to standard treatment, with nearly 30% experiencing tumour progression during treatment, and nearly 6% surviving more than 5 years. To date, there are few non-invasive clinical biomarkers to predict response to first – line treatment. Chemical exchange saturation transfer (CEST) MRI may have the potential to fill this gap. CEST MRI is sensitive to treatment-induced changes and changes in tumor metabolism. Our team has obtained CEST data for patients before, during and after the end of standard chemoradiation treatment, and found that CEST provides markers of early response and can identify early, standard and late progressors before treatment initiation. In this study, we aimed to establish molecular profiles of early, standard and late progressors with IDH wild-type glioblastoma. Patients (n=180) with primary, IDH wild-type glioblastoma were imaged with CEST-MRI at multiple time points throughout standard chemoradiation treatment. DNA and RNA were co-extracted from matched normal and tumour pairs and processed for whole genome sequencing, enzymatic methyl-seq and gene expression analysis using Nanostring. Clinical variables such as age, extent of resection, sex, ECOG status and MGMT promoter methylated were also collected. A survival analysis was conducted using the Kaplan-Meier method with log-rank tests. Univariate and multi-variate hazard ratios for clinical variables were calculated by fitting Cox Proportional Hazards Models. Early progressors reported a median progression-free survival (PFS) of 142 days compared to 832 days in late progressors (p<0.0001). Early progressors also harbored distinct and statistically significant differences in gene expression and genomic alterations, namely in DNA damage repair, glucose transport and arginine metabolism pathways. A gene signature was prognostic of PFS and overall survival. Collectively, this data has the potential to serve as a radiogenomic biomarker to assess treatment response before or within early phases of treatment and allow for individual tailoring of the treatment plan.

Impact of Confucianism on the Early Phase of Analytic Treatment

Impact of Confucianism on the Early Phase of Analytic Treatment

Profiling neuroinflammatory markers and response to nusinersen in paediatric spinal muscular atrophy.

Neuroinflammation is an emerging clinical feature in spinal muscular atrophy (SMA). Characterizing neuroinflammatory cytokines in cerebrospinal fluid (CSF) in SMA and their response to nusinersen is important for identifying new biomarkers and understanding the pathophysiology of SMA. We measured twenty-seven neuroinflammatory markers in CSF from twenty SMA children at different time points, and correlated the findings with motor function improvement. At baseline, MCP-1, IL-7 and IL-8 were significantly increased in SMA1 patients compared to SMA2, and were significantly correlated with disease severity. After six months of nusinersen treatment, CSF levels of eotaxin and MIP-1β were markedly reduced, while IL-2, IL-4 and VEGF-A were increased. The decreases in eotaxin and MIP-1β were associated with changes in motor scores in SMA1. We also detected a transient increase in MCP-1, MDC, MIP-1α, IL-12/IL-23p40 and IL-8 after the first or second injection of nusinersen, followed by a steady return to baseline levels within six months. Our study provides a detailed profile of neuroinflammatory markers in SMA CSF. Our data confirms the potential of MCP-1, eotaxin and MIP-1β as new neuroinflammatory biomarkers in SMA1 and indicates the presence of a subtle inflammatory response to nusinersen during the early phase of treatment.

Family strategies for managing childhood cancer: Using traditional and complementary medicine in Southern Egypt.

The use of traditional and complementary medicine (T&CM) is common in children with cancer globally. We aimed to assess the prevalence, types, reasons, perceived effectiveness, and disclosure rate of T&CM use among children with cancer in Southern Egypt. We also investigated whether T&CM use contributed to delays in initial presentation and treatment. A cross-sectional design was utilized. Data were collected via an interviewer-administered questionnaire. Eligible children and their caregivers at the South Egypt Cancer Institute were invited to participate. Eighty-six children completed the study (response rate=86%). T&CM use was reported by 52 (60.5%) patients, with six (11.5%) experienced delayed presentation. The reasons for T&CM use were complementary for 37 (71%) and alternative for 15 (29%) of the participants. The types of T&CM used included herbal (63%), nutritional (33%), witchcraft (29%), and religious (19%) therapies. Approximately 48% of users employed multiple T&CM types. Family members recommended T&CM for 60% of the users. Most patients (65%) perceived T&CM as effective, with 71% initiating its use during the early phases of treatment. Almost all participants (98%) reported that healthcare providers did not inquire about T&CM use. T&CM usage was more prevalent among wealthier families (p=.023). There was no significant relationship between T&CM use and patient gender, diagnosis, residence, or paternal educational level. The significant utilization of T&CM among children with cancer highlights the need for healthcare providers to engage in open and early discussions with families regarding T&CM use.

Changes in perfusion and permeability in glioblastoma model induced by the anti-angiogenic agents cediranib and thalidomide.

The poor delivery of drugs to infiltrating tumor cells contributes to therapeutic failure in glioblastoma. During the early phase of an anti-angiogenic treatment, a remodeling of the tumor vasculature could occur, leading to a more functional vessel network that could enhance drug delivery. However, the restructuration of blood vessels could increase the proportion of normal endothelial cells that could be a barrier for the free diffusion of drugs. The net balance, in favor or not, of a better delivery of compounds during the course of an antiangiogenic treatment remains to be established. This study explored whether cediranib and thalidomide could modulate perfusion and vessel permeability in the brain U87 tumor mouse model. The dynamic evolution of the diffusion of agents outside the tumor core using the fluorescent dye Evans Blue in histology and Gd-DOTA using dynamic contrast-enhanced (DCE)-MRI. CD31 labelling of endothelial cells was used to measure the vascular density. Cediranib and thalidomide effectively reduced tumor size over time. The accessibility of Evans Blue outside the tumor core continuously decreased over time. The vascular density was significantly decreased after treatment while the proportion of normal vessels remained unchanged over time. In contrast to histological studies, DCE-MRI did not tackle any significant change in hemodynamic parameters, in the core or margins of the tumor, whatever the parameter used or the pharmacokinetic model used. While cediranib and thalidomide were effective in decreasing the tumor size, they were ineffective in transiently increasing the delivery of agents in the core and the margins of the tumor.

Effect of low-level light therapy in individuals with dry eye disease.

Low-level light therapy (LLLT) or photobiomodulation, the application of red light to the eye, is used for the treatment of dry eye. Limited studies have investigated the efficacy of LLLT as a stand-alone treatment. The investigation aimed to evaluate the effect of LLLT on signs and symptoms of dry eye. Participants with mild to moderate dry eye were recruited for this three-visit study. Visits were 7 (±3) days apart and all participants received 633 nm LLLT (eye-light®) for 15 min at each visit. Clinical measures including first and average non-invasive keratograph tear break-up time (NIKBUT), tear meniscus height (TMH), meibomian gland (MG) loss for upper and lower eyelids, ocular surface disease index (OSDI) score, tear film lipid layer thickness, meibum quality score, Schirmer's test, corneal fluorescein staining and eyelid temperature for external upper (EUL) and external lower (ELL) eyelids were measured from the right eye of participants before and after treatment. Thirty participants (mean [SD] age: 31.1 [9.5] years) completed the study. Treatment with LLLT resulted in significant differences in first and average NIKBUT, TMH, tear film lipid layer thickness, OSDI score, Schirmer's test, meibum quality score and eyelid temperature over time (all p < 0.05). Compared to baseline, TMH, tear film lipid layer thickness and eyelid temperature significantly increased by 0.06 mm (95% CI: 0.01-0.11), 12.9 nm (95% CI: 1.18-24.55), and 7.0°C, respectively,for both EUL (95% CI: 6.17-7.84) and ELL (95% CI: 6.17-7.73). The respective decrease in the OSDI score and Schirmer's test was 10.2 (95% CI: -15.15 to -5.26) and 4.4 mm (95% CI: -7.31 to -1.42; all p < 0.05). There was no significant difference in corneal fluorescein staining and MG loss after LLLT. Low-level light therapy treatment significantly improved signs and symptoms of dry eye in the early phases of treatment, suggesting its efficacy for dry eye management.

Development and validation of a predictive scoring model for risk stratification of tuberculosis treatment interruption

BackgroundTuberculosis (TB) treatment interruption poses risks of antimicrobial resistance, potentially leading to treatment failure and mortality. Addressing the risk of early treatment interruption is crucial in tuberculosis care and management to improve treatment outcomes and curb disease transmission. ObjectivesThis study aimed to identify risk factors of TB treatment interruption and construct a predictive scoring model that enables objective risk stratification for better prediction of treatment interruption. MethodsA multicentre retrospective cohort study was conducted at public health clinics in Sarawak, Malaysia over 11 months from March 2022 to January 2023, involving adult patients aged ≥18 years with drug-susceptible TB diagnosed between 2018 and 2021. Cumulative missed doses or discontinuation of TB medications for ≥2 weeks, either consecutive or non-consecutive, was considered as treatment interruption. The model was developed and internally validated using the split-sample method. Multiple logistic regression analysed 18 pre-defined variables to identify the predictors of TB treatment interruption. The Hosmer-Lemeshow test and area under the receiver operating characteristic curve (AUC) were employed to evaluate model performance. ResultsOf 2953 cases, two-thirds (1969) were assigned to the derivation cohort, and one-third (984) formed the validation cohort. Positive predictors included smoking, previously treated cases, and adverse drug reactions, while concurrent diabetes was protective. Based on the validation dataset, the model demonstrated good calibration (P = 0.143) with acceptable discriminative ability (AUC = 0.775). A cutoff score of 2.5 out of 11 achieved a sensitivity of 81 % and a specificity of 64.4 %. Risk stratification into low (0–2), medium (3–5), and high-risk (≥6) categories showed ascending interruption rates of 5.3 %, 18.1 %, and 41.3 %, respectively (P < 0.001). ConclusionThe predictive scoring model aids in risk assessment for TB treatment interruption, enabling focused monitoring and personalized intervention plans for higher-risk groups in the early treatment phase.

Clinical outcomes of multidrug-resistant tracheobronchial tuberculosis receiving anti-tuberculosis regimens containing bedaquiline or delamanid

The treatment of multidrug-resistant tracheobronchial tuberculosis poses challenges, and research investigating the efficacy of bedaquiline or delamanid as treatment for this condition is limited. This retrospective cohort study was conducted from 2017 to 2021. The study extracted data of patients with multidrug-resistant tracheobronchial tuberculosis from medical records and followed up on prognoses. Participants were divided into three groups: the bedaquiline, delamanid, and control group. Clinical outcomes and the risk factors associated with early culture conversion were analyzed. This study included 101 patients, with 32, 25, and 44 patients in the bedaquiline, delamanid, and control groups respectively. The differences in the treatment success rates among the three groups did not show statistical significance. Both the bedaquiline and delamanid groups had significantly higher culture conversion rates compared to the control after 2 or 6 months of treatment, with significantly shorter median times to culture conversion (bedaquiline group: 2 weeks, delamanid group: 2 weeks, control group: 12 weeks, P < 0.001). Treatment with bedaquiline or delamanid were identified as independent predictors of culture conversion at 2 months (bedaquiline group: aOR = 13.417, 95% CI 4.067–44.260, delamanid group: aOR = 9.333, 95% CI 2.498–34.878) or 6 months (bedaquiline group: aOR = 13.333, 95% CI 3.379–52.610, delamanid group: aOR = 5.000, 95% CI 1.357–18.426) of treatment through multivariable logistic regression analyses. The delamanid group showed better improvement in lumen stenosis compared to bedaquiline. Regimens containing bedaquiline or delamanid may accelerate the culture conversion during the early treatment phase in multidrug-resistant tracheobronchial tuberculosis, and delamanid appears to have the potential to effectively improve airway stenosis.

A smartphone app-based mindfulness intervention to enhance recovery from substance use disorders: Protocol for a pilot feasibility randomized controlled trial

BackgroundPoor long-term recovery outcomes after treatment (e.g., readmission to inpatient treatment) are common among individuals with substance use disorders (SUDs). In-person mindfulness-based treatments (MBTs) are efficacious for SUDs and may improve recovery outcomes. However, existing MBTs for SUD have limited public health reach, and thus scalable delivery methods are needed. A digitally-delivered MBT for SUDs may hold promise. MethodsWe recently developed Mindful Journey, a smartphone app-based adjunctive MBT for improving long-term recovery outcomes. In this paper, we present details on the app and describe the protocol for a single-site pilot feasibility randomized controlled trial of Mindful Journey. In this trial, individuals (n = 34) in an early phase of outpatient treatment for SUDs will be randomized to either treatment-as-usual (TAU) plus Mindful Journey, or TAU only. The trial will focus on testing the feasibility (e.g., engagement) and acceptability of the app (e.g., perceived usability and helpfulness for recovery), as well as feasibility of study procedures (e.g., assessment completion). The trial will incorporate ecological momentary assessment before and after treatment to assess mechanisms in real-time, including mindfulness, craving, difficulties with negative emotion regulation, and savoring. To examine the sensitivity to change of outcomes (substance use, substance-related problems, and psychological distress) and mechanism variables (noted above), we will test within-treatment-condition changes over time. DiscussionThe proposed pilot trial will provide important preliminary data on whether Mindful Journey is feasible and acceptable among individuals with SUDs. Trial registrationClinicalTrials.gov NCT05109507.

The influence of complex psychiatric comorbidities on treatment for clinical high-risk for psychosis: A preliminary study.

Despite increasingly refined tools for identifying individuals at clinical high-risk for psychosis (CHR-P), less is known about the effectiveness of CHR-P interventions. The significant clinical heterogeneity among CHR-P individuals suggests that interventions may need to be personalized during this emerging illness phase. We examined longitudinal trajectories within-persons during treatment to investigate whether baseline factors predict symptomatic and functional outcomes. A total of 36 CHR-P individuals were rated on attenuated positive symptoms and functioning at baseline and each week during CHR-P step-based treatment. Linear mixed-effects models revealed that attenuated positive symptoms decreased during the study period, while functioning did not significantly change. When examining baseline predictors, a significant group-by-time interaction emerged whereby CHR-P individuals with more psychiatric comorbidities at baseline (indicating greater clinical complexity) improved in functioning during the study period relative to CHR-P individuals with fewer comorbidities. Individual differences in clinical complexity may predict functional response during the early phases of CHR-P treatment.

Client and family experiences with telehealth-delivered early psychosis services.

The COVID-19 pandemic prompted a significant shift to delivering early psychosis services using telehealth. Little is known about the experience of using telehealth in early psychosis services. This quality improvement qualitative project investigated the experiences of program participants and family members with telehealth services in OnTrackNY, an early intervention program for psychosis in New York State during the COVID-19 pandemic. The project team conducted individual interviews and focus groups. Data analyses used a matrix approach. Nineteen OnTrackNY program participants and nine family members participated in five focus groups and nine individual interviews. Data were organized into five themes (a) accessibility: most individuals had a device and internet access and challenges were related to connectivity, such as image freezing and sound breaking; (b) convenience/flexibility: benefits included the reduced commute and costs; (c) levels of comfort/privacy with telehealth: program participants felt less judged and less anxiety leading up to in-person appointments while also expressing privacy concerns; (d) sense of connectedness: in-person social connections were deemed important and not replaceable by telehealth; and (e) suggestions: program participants expressed a preference for in-person group activities and suggested hybrid options, highlighting the importance of in-person visits to establish rapport at the beginning of treatment before transitioning to telehealth. Telehealth services were generally well accepted. Suggestions for future service delivery include offering a combination of telehealth and in-person services based on program participants' preferences and prioritizing in-person services during the early phase of treatment.

Feasibility, satisfaction, and goal attainment in routine telemedicine consultation in child and adolescent psychiatry and psychotherapy.

Telehealth services were rapidly adopted during the COVID-19 pandemic, but evidence regarding the effectiveness and feasibility of telehealth services in child and adolescent mental healthcare is sparse. This study aims to investigate feasibility, satisfaction, and goal attainment in video-delivered consultations in routine care child and adolescent psychiatry and psychotherapy. A total of 1046 patients from four university child and adolescent outpatient psychiatric clinics and one university outpatient unit for child and adolescent psychotherapy were screened for study participation. We examined a) the percentage of patients considered eligible for video-delivered consultation, b) clinicians', parents' and patients' satisfaction with video consultation, c) clinicians' ratings of goal attainment in video consultation, and d) factors associated with satisfaction and goal attainment. 59% of the screening sample (n = 621) fulfilled eligibility criteria and were considered eligible for video consultation. A total of 267 patients consented to participate in the study and received a video consultation. Clinicians reported high levels of satisfaction with video consultation and high levels of goal attainment in video consultations, especially for patients scheduled for initial patient assessments. Parents and patients were also highly satisfied with the video consultations, especially if patients had less severe emotional and behavioral problems. The present findings suggest that video consultations are a feasible and well-accepted alternative to in-person consultations in child and adolescent mental health care, especially for children with less severe symptoms and for children in early phases of assessment and treatment. Limitations include the lack of a control group. The study was registered at the German Clinical Trials Registry (DRKS00023525).

Impact of ciprofloxacin prophylaxis on blood stream infection during early treatment phase of pediatric acute lymphoblastic leukemia: An observational cohort study

PurposeData on the efficacy of antibiotic prophylaxis in children with acute lymphoblastic leukemia (ALL) is scarce and recent guidelines advise against its use. This study is conducted to evaluate if the use of ciprofloxacin prophylaxis is associated with a decrease in blood stream infection (BSI) incidence in children with newly diagnosed ALL. MethodsThis was a retrospective, observational cohort study. Patients were newly diagnosed with ALL between 2020 and 2021 (prophylaxis group) or 2021–2022 (no prophylaxis group). Primary outcome was occurrence of BSI caused by Gram-negative pathogens or Staphylococcus aureus during induction or consolidation I. Secondary outcomes were Pediatric Intensive Care Unit (PICU) admission, mortality, ciprofloxacin resistance and Clostridioides difficile-associated diarrhea (CDAD). ResultsTwo hundred patients were included (prophylaxis group n=94, no prophylaxis group n=106). Ciprofloxacin prophylaxis was associated with significantly lower BSI-incidence (HR 0.37; 95 % CI 0.15–0.94) There was no significant difference for BSI-related PICU admission (OR 0.37; 95 % CI 0.04–3.61), BSI-related mortality (1.1 % vs 0 %), all-cause mortality (OR 0.55; 95 % CI 0.10–3.10), and short-term resistance rates (16.0 % vs 13.0, OR 1.2; 95 % CI, 0.57–2.74) or CDAD (0 % vs 0.9 %) between the prophylaxis group and no prophylaxis group. ConclusionThe use of ciprofloxacin prophylaxis was associated with a significantly lower incidence of BSI. While this finding shows the beneficial effect of ciprofloxacin prophylaxis in the first treatment phase of ALL, RCTs with a large sample size are needed, particularly to assess the effect on ciprofloxacin resistance.

Therapeutic efficacy of candidate antischistosomal drugs in a murine model of schistosomiasis mansoni.

Schistosomiasis is a neglected tropical disease associated with considerable morbidity. Praziquantel (PZQ) is effective against adult schistosomes, yet, it has little effect on juvenile stages, and PZQ resistance is emerging. Adopting the drug repurposing strategy as well as assuming enhancing the efficacy and lessening the doses and side effects, the present study aimed to investigate the in vivo therapeutic efficacy of the widely used antiarrhythmic, amiodarone, and diuretic, spironolactone, and combinations of them compared to PZQ. Mice were infected by Schistosoma mansoni "S. mansoni" cercariae (Egyptian strain), then they were divided into two major groups: Early- [3weeks post-infection (wpi)] and late- [6 wpi] treated. Each group was subdivided into seven subgroups: positive control, PZQ, amiodarone, spironolactone, PZQ combined with amiodarone, PZQ combined with spironolactone, and amiodarone combined with spironolactone-treated groups. Among the early-treated groups, spironolactone had the best therapeutic impact indicated by a 69.4% reduction of total worm burden (TWB), 38.6% and 48.4% reduction of liver and intestine egg load, and a significant reduction of liver granuloma number by 49%. Whereas, among the late-treated groups, amiodarone combined with PZQ was superior to PZQ alone evidenced by 96.1% reduction of TWB with the total disappearance of female and copula in the liver and intestine, 53.1% and 84.9% reduction of liver and intestine egg load, and a significant reduction of liver granuloma number by 67.6%. Comparatively, spironolactone was superior to PZQ and amiodarone in the early treatment phase targeting immature stages, while amiodarone had a more potent effect when combined with PZQ in the late treatment phase targeting mature schistosomes.

Assessing the needs of patients with breast cancer and their families across various treatment phases using a Latent Dirichlet Allocation model: a text-mining approach to online health communities.

This study aimed to assess the different needs of patients with breast cancer and their families in online health communities at different treatment phases using a Latent Dirichlet Allocation (LDA) model. Using Python, breast cancer-related posts were collected from two online health communities: patient-to-patient and patient-to-doctor. After data cleaning, eligible posts were categorized based on the treatment phase. Subsequently, an LDA model identifying the distinct need-related topics for each phase of treatment, including data preprocessing and LDA topic modeling, was established. Additionally, the demographic and interactive features of the posts were manually analyzed. We collected 84,043 posts, of which 9504 posts were included after data cleaning. Early diagnosis and rehabilitation treatment phases had the highest and lowest number of posts, respectively. LDA identified 11 topics: three in the initial diagnosis phase and two in each of the remaining treatment phases. The topics included disease outcomes, diagnosis analysis, treatment information, and emotional support in the initial diagnosis phase; surgical options and outcomes, postoperative care, and treatment planning in the perioperative treatment phase; treatment options and costs, side effects management, and disease prognosis assessment in the non-operative treatment phase; diagnosis and treatment options, disease prognosis, and emotional support in the relapse and metastasis treatment phase; and follow-up and recurrence concerns, physical symptoms, and lifestyle adjustments in the rehabilitation treatment phase. The needs of patients with breast cancer and their families differ across various phases of cancer therapy. Therefore, specific information or emotional assistance should be tailored to each phase of treatment based on the unique needs of patients and their families.

Pegvaliase for the treatment of phenylketonuria: Final results of a long-term phase 3 clinical trial program

Phenylketonuria (PKU) is a genetic disorder caused by deficiency of the enzyme phenylalanine hydroxylase (PAH), which results in phenylalanine (Phe) accumulation in the blood and brain, and requires lifelong treatment to keep blood Phe in a safe range. Pegvaliase is an enzyme-substitution therapy approved for individuals with PKU and uncontrolled blood Phe concentrations (>600 μmol/L) despite prior management. Aggregated results from the PRISM clinical trials demonstrated substantial and sustained reductions in blood Phe with a manageable safety profile, but also noted individual variation in time to and dose needed for a first response. This analysis reports longer-term aggregate findings and characterizes individual participant responses to pegvaliase using final data from the randomized trials PRISM-1 (NCT01819727) and PRISM-2 (NCT01889862), and the open-label extension study 165–304 (NCT03694353). In 261 adult participants with a mean of 36.6 months of pegvaliase treatment, 71.3%, 65.1%, and 59.4% achieved clinically significant blood Phe levels of ≤600, ≤360, and ≤ 120 μmol/L, respectively. Some participants achieved blood Phe reductions with <20 mg/day pegvaliase, although most required higher doses. Based on Kaplan-Meier analysis, median (minimum, maximum) time to first achievement of a blood Phe threshold of ≤600, ≤360, or ≤ 120 μmol/L was 4.4 (0.0, 54.0), 8.0 (0.0, 57.0), and 11.6 (0.0, 66.0) months, respectively. Once achieved, blood Phe levels remained below clinical threshold in most participants. Sustained Phe response (SPR), a new method described within for measuring durability of blood Phe response, was achieved by 85.5%, 84.7%, and 78.1% of blood Phe responders at blood Phe thresholds of ≤600, ≤360, or ≤ 120 μmol/L, respectively. Longer-term safety data were consistent with previous reports, with the most common adverse events (AEs) being arthralgia, injection site reactions, headache, and injection site erythema. The incidence of most AEs, including hypersensitivity AEs, was higher during the early treatment phase (≤6 months) than later during treatment. In conclusion, using data from three key pegvaliase clinical trials, participants treated with pegvaliase were able to reach clinically significant blood Phe reductions to clinical thresholds of ≤600, ≤360, or ≤ 120 μmol/L during early treatment, with safety profiles improving from early to sustained treatment. This study also supports the use of participant-level data and new ways of looking at durable blood Phe responses to better characterize patients' individual PKU treatment journeys.

Impact of Clinical Trial Design on Recruitment of Racial and Ethnic Minorities.

Knowledge related to how oncology treatment trial design influences enrollment of racial and ethnic minorities is limited. Rigorous identification of clinical trial design parameters that associate favorably with minority accrual provides educational opportunities for individuals interested in designing more representative treatment trials. We identified oncology trials with a minimum of 10 patients at an NCI-Designated Comprehensive Cancer Center from 2010 to 2021. We defined a study endpoint of racial and ethnic minority accrual greater than zero. Multivariable logistic regression was used to determine whether co-variables predicted our study endpoint. P-values of less than 0.05 were considered significant. A total of 352 cancer trials met eligibility criteria. These studies enrolled a total of 7981 patients with a total of 926 racial and ethnic minorities leading to a median enrollment of 10%. Trials open in community sites (yes versus no) were more likely to have a minority patient (OR, 2.21; 95% CI, 1.02-4.96) as well as pilot/phase I studies compared to phase II/III (OR, 3.19; 95% CI, 1.34-8.26). Trials incorporating immunotherapy (yes versus no) were less likely to have a minority patient (OR, 0.47; 95% CI, 0.23-0.94). Trials open in community sites as well as early phase treatment studies were more likely to accrue minority patients. However, studies including immunotherapy were less likely to accrue racial and ethnic minorities. Knowledge gained from our analysis may help individuals design oncology treatment trials that are representative of more diverse populations.

Early and Intensive Management of Chemical Eye Injuries: Case Series

Chemical injuries of the eyes are true ophthalmic emergencies causing significant visual morbidities. They require urgent and immediate assessment and intervention. They are more common in young adults either due to accidental causes or due to criminal assaults. They severely damage the ocular structures; surface epithelium, cornea, conjunctiva, limbal stem cells and can cause permanent unilateral or bilateral vision loss. In this article, we are trying to emphasis on the importance of initiating treatment in the early phase of ocular chemical injury and also emphasizing on extent of chemical ocular injuries, their severity and their varied outcomes through two different types of cases; one with good visual recovery with early initiation of treatment and the other developing complications in spite of being initiating treatment in early phase.

Parent-patient Discrepancies in the Quality of Life Assessment of Early-onset Scoliosis: A Comparison Between 2 Questionnaires Completed on 2 Different Time Points - A Preliminary Report.

EOSQ-24 is a parent proxy questionnaire designed to assess the health-related quality of life (HRQoL) of early-onset scoliosis (EOS) patients during their childhood years. EOSQ-SELF, a novel self-reported questionnaire, assesses HRQoL in older children (>8y) and adolescents. So far, the same group of EOS patients has not been evaluated with both EOSQ-24 and EOSQ-SELF. The aim of this study was to evaluate how the same pathology was reflected in the parent and patient at different time points by comparing the answers to the common questions between EOSQ-24 and EOSQ-SELF. A group of otherwise healthy EOS patients whose parents filled out EOSQ-24 at the early phase of growth-friendly treatment was re-tested by the EOSQ-SELF questionnaire at the end of treatment. Both EOSQ-24 and EOSQ-SELF are validated in Turkish. Inclusion criteria were patients with EOS, independent ambulation, age of 8 years or older at EOSQ-SELF enrollment, literacy in Turkish, no apparent intellectual impairment, and a minimum of 24 months after graduation. The common questions between the 2 surveys with nearly identical phrasings were extracted. Common items from the 2 tests were compared with a Wilcoxon signed rank test. Twenty-one patients (15 females, 6 males) who previously filled out EOSQ-24 met the inclusion criteria. The mean age of the group was 10 (5 to 16) years at EOSQ-24 participation and 18 (13 to 24) at the final analysis. Fourteen questions were found common in 10 domains. The scores were significantly different in 5 questions of 4 domains. EOSQ-SELF had significantly less favorable scores in the pain/discomfort, pulmonary function, and fatigue/energy level domains. Scores in the parental burden/relationships domain were significantly higher (P<0.05). The self-reported group had a general trend of worse results. Parents and caregivers may not accurately perceive the problems of EOS patients. Our findings indicate a disconnect between caregivers and the patients, as both parties underreported the other side in some domains. These findings suggest the challenges faced by EOS patients are not adequately reflected on proxy questionnaires that assess the HRQoL of children. Diagnostic Level I.

Caregiver perceptions of child heath behaviors and weight during treatment for acute lymphoblastic leukemia.

Changes in health behaviors and weight are common during the early phases of pediatric acute lymphoblastic leukemia treatment, and may negatively impact treatment tolerability. Given that ALL is most prevalent in children, caregivers play an essential role in shaping health behaviors during treatment. This study presents a qualitative analysis of semi-structured interviews with caregivers of youth in the early phases of ALL treatment. Caregivers (N=17, 95% female) of a child (M age=6.76years) diagnosed with ALL and on treatment for less than 1year (M=8.7months since diagnosis) completed a semi-structured interview about perceptions of their child's nutrition, physical activity, sedentary time, and weight during ALL treatment. Thematic analysis followed Braun and Clark's six-step framework (2006). Two coders established reliability (alpha=.88) and used a multi-pass coding system to extract themes. Caregivers' concerns around their child's weight during ALL treatment primarily centered around avoiding malnutrition. Weight gain during treatment was less of a concern and often viewed as protective. Caregivers reported encouraging their child to eat palatable, calorie-dense foods to mitigate risk for weight loss. Caregivers also expressed concern that children were less active and more sedentary due to treatment-related pain. Caregivers discussed health behaviors during treatment as being child-directed, rather than parent- or provider-directed. Future interventions may consider strategies to engage in joint parent-child decisions and caregiver education around risks of excessive weight gain during treatment. Interventions should include anticipatory guidance and aim to support parents in developing skills to support their child's health behaviors during treatment.