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Safety of tarlatamab with 6-8-h outpatient versus 48-h inpatient monitoring during cycle 1: DeLLphi-300 phase 1 substudy
No full textBACKGROUND: Tarlatamab, a bispecific T-cell engager immunotherapy targeting delta-like ligand 3, has demonstrated promising survival outcomes in small-cell lung cancer (SCLC). Given the risk of cytokine release syndrome (CRS), initial clinical trials incorporated 48-72-h inpatient monitoring in cycle 1.
METHODS: Patients with previously treated SCLC were enrolled into DeLLphi-300 part F, which evaluated the safety of tarlatamab 10 mg every 2 weeks (Q2W) with 6-8-h outpatient monitoring following cycle 1 doses. The primary endpoint, safety, was compared with patients from DeLLphi-300 part A receiving tarlatamab 10 mg Q2W with 48-h inpatient monitoring for cycle 1 doses.
RESULTS: In cycle 1, the rates of treatment-related adverse events and hospitalizations, including emergency room visits, were similar between outpatient (n = 30) and inpatient (n = 58) groups (93% versus 100% and 27% versus 34%, respectively). The incidence of all grade and serious CRS during cycle 1 was similar between outpatient and inpatient groups (any grade: 60% versus 62%; serious: 17% versus 22%). The median time to CRS resolution was 3 days for both groups.
CONCLUSIONS: Safety outcomes, including hospitalization rates, were similar in this first-in-human study following tarlatamab 10 mg Q2W administration with 6-8-h outpatient versus 48-h inpatient monitoring in cycle 1
Operative considerations for resection of pituitary adenoma in patients with sickle cell disease: A retrospective analysis of 19,653 patients
No full textBACKGROUND: Sickle cell disease (SCD) is a hemoglobinopathy that affects over 30 million individuals worldwide. When significant sickling occurs, blood flow to specific organs can be impaired, resulting in ischemia or infarction. This can be problematic during intracranial surgery, in which low systemic circulatory volume due to significant blood loss can lead to intracranial hypotension. Using a multivariable modeling approach, we gathered a large patient dataset through a nationally representative database to inform future neurosurgical management of patients with concurrent SCD and pituitary adenoma.
METHODS: We queried the Healthcare Cost and Utilization Project Nationwide Readmissions Database and implemented discharge weighting to identify a cohort of SCD patients who had undergone surgical resection of pituitary adenoma between 2015 and 2016. Variables investigated included patient age, sex, length of stay, postoperative complications and outcomes, payment methods, and median income, among several others.
RESULTS: Retrospective analysis identified 19,612 non-sickle cell patients (NSCP) and 41 SCD patients. Complication profiles for the SCD cohort demonstrated significantly higher rates of postoperative pulmonary embolism (P = 0.042) and pneumonia (P = 0.005) compared to those of the NSCP cohort. In addition, the SCD cohort trended toward higher rates of readmission (15.25% vs. 9.76%) and deep vein thrombosis, although neither achieved statistical significance (P = 0.45 and 0.07, respectively).
CONCLUSION: SCD is a severe disorder that affects many individuals worldwide and represents a significant risk factor for complications and adverse outcomes in pituitary adenoma surgery. Further research is needed to explore SCD as a risk factor in pituitary surgery and the role it may play in perioperative complications
Risk Factors of Long-Term Opioid Use After Elective Cervical and Lumbar Spine Surgery: A Michigan Spine Surgery Improvement Collaborative Study
No full textBACKGROUND AND OBJECTIVES: Given the current opioid epidemic and its impact on public health, long-term opioid use after elective spine surgery is a significant concern. Identifying risk factors of long-term opioid use after spine surgery is crucial for developing effective interventions to reduce opioid dependence in this patient population. The objective of this study was to identify risk factors associated with long-term opioid use after elective lumbar and cervical spine surgeries.
METHODS: A retrospective analysis of patient data was conducted using the Michigan Spine Surgery Improvement Collaborative data registry. Patients who underwent elective lumbar or cervical spine surgery between March 2018 and September 2021 were included. Poisson generalized estimating equation models were used for multivariate analyses.
RESULTS: A total of 5301 and 3992 lumbar surgery patients at 1 and 2 years, respectively, and a total of 2074 and 1451 cervical surgery patients at 1 and 2 years, respectively, were included for analysis. Preoperative opioid use, opioid use at 90 days postoperatively, and poor functional status were the strongest predictors of long-term opioid use. Among all patients, preoperative opioid use most strongly predicted long-term use at 1 and 2 years for lumbar and cervical patients. Among opioid-naïve patients (preoperative nonusers), opioid use at 90 days postoperatively strongly predicted continued use at 1 and 2 years in both lumbar and cervical patients. The inability to achieve a minimal clinically important difference in Patient-Reported Outcomes Measurement Information System physical function was also associated with opioid use at 1-year and 2-year follow-up in lumbar and cervical patients.
CONCLUSION: Preoperative opioid use, opioid use at 90 days postoperatively, and failure to reach minimal clinically important difference of Patient-Reported Outcomes Measurement Information System Physical Function were the strongest predictors of long-term opioid use after elective lumbar and cervical spine surgeries
Establishing the content validity of Patient-Reported Outcome measures used in neuro-oncology based on the WHO ICF framework: part of the RANO-PRO initiative
No full textBACKGROUND: Instruments to assess patient-reported outcomes (PRO) should generate high-quality evidence. Reliable PRO evidence is essential to policymakers, in conjunction with outcomes such as survival and radiological response, to understand the net clinical benefit of antitumor treatments. This study aimed to establish the content validity of 215 identified PRO measures used in patients with brain tumors.
METHODS: A survey (n = 148 items) was developed reflecting aspects of the WHO International Classification of Functioning, Disability, and Health (ICF) framework. Patients with brain tumors, their proxies, and healthcare providers (HCPs) were asked to rate each survey item on relevance. An item was considered a relevant issue if ≥25% of the patients, proxies, or ≥50% of the HCPs considered that item to be an issue. Next, all items in the identified PRO measures were linked to ICF and relevant items in the survey, and the percentage of content coverage was calculated.
RESULTS: In total, 114 patients, 71 proxies, and 65 HCPs from different countries completed the survey. Fifty-six of 148 (37.8%) items in the survey were considered relevant. The most important aspects mentioned by both patients and proxies were difficulty concentrating, difficulty remembering, multitasking, and handling stress. Depending on the definition, between 35% and 49% of PRO measures were considered to have sufficient content validity (≥80% coverage).
CONCLUSION: The content validity was insufficient in more than half of the identified PRO measures, particularly multidimensional measures. Future research should investigate whether different approaches to PRO assessment better meet the needs of all stakeholders
The Patient Acceptable Symptom State (PASS) has Little Utility Before Total Hip or Knee Arthroplasty
No full textBACKGROUND: A better understanding of patient\u27s a preoperative symptom state may assist in a more holistic evaluation of patients pursuing total joint arthroplasty (TJA). This study aimed to determine factors associated with preoperative Patient Acceptable Symptom State (PASS) scores in TJA patients and to determine the predictive ability of patient-reported outcome measures (PROMs) for achieving PASS preoperatively.
METHODS: All patients undergoing primary, elective TJA between January and October 2021 at a single institution and who had completed a preoperative PASS, preoperative Patient-Reported Outcome Measurement Information System (PROMIS) questionnaires, and joint-specific PROMs were eligible for inclusion. Descriptive statistics and independent samples t-tests were utilized. Receiver operating characteristic curves and area under the curve analyses were created to determine threshold values for PROMs representing PASS achievement.
RESULTS: A total of 287 total hip arthroplasty (THA) patients and 378 total knee arthroplasty (TKA) patients completed PASS preoperatively, with 12.9% of THA patients and 29.6% of TKA patients reporting acceptable symptom states. The PASS responses were associated with PROMIS Physical Function (PROMIS-PF) (P \u3c 0.001) but not Hip Dysfunction and Osteoarthritis Score, Joint Replacement (P = 0.073) scores in THA. The PASS responses were similarly associated with PROMIS-PF (P \u3c 0.010) as well as Knee Injury and Osteoarthritis Outcome Score, Joint Replacement (P = 0.030) scores in TKA. The Hip Dysfunction and Osteoarthritis Score, Joint Replacement and PROMIS-PF threshold values of 55.6 and 40, respectively, only weakly predicted preoperative PASS achievement in THA. The Knee Injury and Osteoarthritis Outcome Score, Joint Replacement and PROMIS-PF threshold values of 52.5 and 39, respectively, only weakly predicted preoperative PASS achievement in TKA.
CONCLUSIONS: In patients undergoing THA or TKA, 12.9 and 29.6% of patients were satisfied with their symptoms before surgery, respectively. None of the threshold values for the assessed PROMs strongly predict PASS achievement. Given that not all patients indicated for TJA reported unacceptable health states, these findings question the validity of the PASS questionnaire preoperatively
Human papillomavirus-related cancers and human papillomavirus vaccination among Arab Americans: A call to unveil disparities and bridge the research gaps
No full textArab Americans, a diverse and rapidly growing demographic in the United States, face unique barriers to human papillomavirus (HPV) vaccination and cancer prevention, but there is a notable lack of research on HPV‐associated cancer incidence and vaccination rates in this community. Collaborative efforts among health care providers, public health agencies, researchers, and religious community organizations are essential to improve HPV vaccination uptake and reduce cancer disparities within this underserved population by including Middle Eastern and North African as a distinct category in national health surveys, conducting comprehensive epidemiological research, and developing culturally tailored interventions
The Use of Breast Cup Immobilization in Radiation Therapy and Patient-Reported Outcomes on Cosmesis and Pain
No full textPURPOSE: Breast cosmesis and breast pain are among the most reported outcomes in patients undergoing adjuvant breast irradiation. The degree to which such adverse reactions occur can be variable based on different patient-specific characteristics. It has been found that women with a larger body habitus, and larger breasts, tend to have an increased chance of experiencing worse toxicity from treatment. As such, attempts to improve cosmetic and pain outcomes have been a highly explored topic. One such technique, that is studied here, is to explore whether the use of a breast cup during treatment leads to worse breast pain and cosmetic outcomes when compared with those treated without a breast cup. This proves to be an important topic because it is believed that the use of a breast cup would provide a significant dosimetric advantage (ie, breast coverage and organ at risk dosing) during treatment. We now explore this treatment option through the scope of a retrospective analysis of patient-reported outcomes experienced during and after completing postoperative radiation therapy to the breast.
METHODS AND MATERIALS: A total of 645 patients undergoing adjuvant breast irradiation were evaluated from 2011 to 2019. Of the 645 patients, 79 were treated using a breast cup. The mean heart dose was analyzed and compared between the 2 treatment groups. Additionally, patient-reported outcomes among the entire cohort were collected via survey documentation forms during treatment, at 1 month after the completion of treatment, and at 1 year after the completion of treatment. These results were collected using the Michigan Radiation Oncology Quality Consortium database because each patient was consented to enroll in the Michigan Radiation Oncology Quality Consortium prior to starting treatment. The outcomes of skin changes, lymphedema, and breast pain among the 2 treatment groups were then compared for statistically significant differences via a logistic regression analysis.
RESULTS: Of the 79 patients treated with a breast cup, grade 2 pruritus of the treated breast along with grade 1 alteration in skin texture was reported in 49.4%, 35.4%, and 22.8% while on treatment, at 1 month after the completion of treatment, and at 1 year after treatment, respectively; P-values were nonsignificant at all timepoints when data compared with non-cup-treated patients. With regard to lymphedema, 59.5%, 40.5%, and 10.1% of breast cup patients at the prespecified timepoints reported this sequela; all P-values were nonsignificant except for the 1-month mark (P-value .03). Lastly, breast pain was noted in 36.7%, 15.2%, and 11.4% of breast cup-treated patients while on treatment, at 1 month after the completion of treatment, and at 1 year after treatment, respectively; again, P-values for data analysis at each timepoint were nonsignificant. Other than the patient-reported outcome of lymphedema 1 month after the completion of treatment, no statistical significance was seen in comparing side effects between the 2 treatment arms.
CONCLUSIONS: From our patients\u27 perspective, the use of a breast cup during radiation therapy did not negatively impact breast cosmesis or pain when compared with patients treated without a cup. Furthermore, breast cup use was also found to produce a lower overall mean heart dose in patients with left-sided breast cancer
Nightmares and insomnia within the acute aftermath of trauma prospectively predict suicidal ideation
No full textSTUDY OBJECTIVE: Acute trauma patients are vulnerable to suicidality following hospitalization. Research suggests nightmares and insomnia may interact to potentiate suicidality, possibly due to nightmares worsening co-occurring insomnia. Nightmares and insomnia are common stress reactions to acute trauma and might compound suicide risk within acutely traumatized patients. We tested the prospective relationship between nightmares and insomnia immediately after trauma on future suicidal ideation (SI).
METHODS: Patients hospitalized in Detroit, MI following traumatic injury (M (age) = 39.53 ± SD 14.31 years, 67.0% male, 67.0% Black) completed surveys at three post-trauma timepoints: one week (T1; N = 88), one month (T2; n = 61), and two months (T3; n = 59).
RESULTS: Patients with clinically significant nightmares and comorbid insomnia symptoms at T2 reported the highest rates of SI at T3 (42.9%), whereas patients with insomnia alone (8.0%) or neither sleep disturbance (6.7%) had the lowest SI rates (ps \u3c .05). We observed an interaction effect wherein insomnia symptoms at T2 predicted increased SI at T3, but only among patients with comorbid nightmares at T2. This interaction remained after accounting for acute stress symptoms at T2. Post-hoc analyses showed nighttime awakenings and total wake time at T2 predicted increased SI at T3 with nightmares also moderating this prospective effect.
CONCLUSIONS: These novel results suggest clinically significant nightmares strengthen the association between insomnia and suicidality after trauma. As nearly half of acute trauma patients with nightmares and insomnia experience SI two months after trauma, early interventions that target both may curb SI rates
Assessing Public Interest in Online Men\u27s Health Services: A Cross-Sectional Google Trends Analysis of Hims
No full textOBJECTIVE: To evaluate public interest in Hims, a men\u27s health platform, to assess its impact on healthcare access, and identify geographic trends reflecting gaps in traditional healthcare availability.
METHODS: Relative search volume (RSV) data for erectile dysfunction and early climax terms in Hims were collected via Google Trends from November 2017 to December 2023 across the United States. Data were analyzed in two intervals (2017-2020 and 2020-2023) using paired t tests to compare RSV and Kruskal-Wallis tests to assess differences among terms. Geographic regions were examined to identify underserved regions.
RESULTS: Public interest in Hims increased significantly, with median RSV rising from 0 (interquartile range (IQR): 0-33) in 2017-2020 to 62 (IQR: 30-95) in 2020-2023 (P \u3c .05). Searches related to erectile dysfunction rose from a median RSV of 18 (IQR: 0-100) to 46 (IQR: 0-100) (P \u3c .001), with similar growth observed in searches related to early climax. High RSV was noted in states like Colorado, Wyoming, and Maine, highlighting increased interest in regions with limited healthcare resources. A marked rise in telehealth engagement during the COVID-19 pandemic further emphasized the role of digital platforms in healthcare delivery during periods of restricted access.
CONCLUSION: The rise in search interest for Hims underscores the increasing demand for telehealth services to for men\u27s health, particularly in underserved regions. These findings highlight the potential of digital platforms to bridge gaps in healthcare access
