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Magnetic resonance (MR)-guided near-infrared spectral tomography was developed and used to image adipose and fibroglandular breast tissue of 11 normal female subjects, recruited under an institutional review board-approved protocol. Images of hemoglobin, oxygen saturation, water fraction, and subcellular scattering were reconstructed and show that fibroglandular fractions of both blood and water are higher than in adipose tissue. Variation in adipose and fibroglandular tissue composition between individuals was not significantly different across the scattered and dense breast categories. Combined MR and near-infrared tomography provides fundamental molecular information about these tissue types with resolution governed by MR T1 images.

The COVID-19 pandemic necessitated a rapid shift to telemedicine to minimize patient and provider exposure risks. While telemedicine has been used in a variety of primary and specialty care settings for many years, it has been slow to be adopted in oncology care. Health care provider and administrator perspectives on factors affecting telemedicine use in oncology settings are not well understood, and the conditions associated with the COVID-19 pandemic offered the opportunity to study the adoption of telemedicine and the resulting provider and staff perspectives on its use. The aim of this paper is to study the factors that influenced telemedicine uptake and sustained use in outpatient oncology clinics at a US cancer center to inform future telemedicine practices. We used purposive sampling to recruit a mix of oncology specialty providers, practice managers, as well as nursing and administrative staff representing 5 outpatient oncology clinics affiliated with the Dartmouth Cancer Center, a large regional cancer center in the northeast of United States, to participate in semistructured interviews conducted over 6 weeks in spring 2021. The interview guide was informed by the 5 domains of the Consolidated Framework for Implementation Research, which include inner and outer setting factors, characteristics of the intervention (ie, telemedicine modality), individual-level factors (eg, provider and patient characteristics), and implementation processes. In total, 11 providers, 3 leaders, and 6 staff participated following verbal consent, and thematic saturation was reached across the full sample. We used a mixed deductive and inductive qualitative analysis approach to study the main influences on telemedicine uptake, implementation, and sustainability during the first year of the COVID-19 pandemic across the 5 settings. The predominant influencers of telemedicine adoption in this study were individual provider experiences and assumptions about patient preference and accessibility. Providers' early telemedicine experiences, especially if negative, influenced preferences for telephone over video and affected sustained use. Telemedicine was most favorably viewed for lower-acuity cancer care, visits less dependent on physical exam, and for patient and caregiver education. A lack of clinical champions, leadership guidance, and vision hindered the implementation of standardized practices and were cited as essential for telemedicine sustainability. Respondents expressed anxiety about sustaining telemedicine use if reimbursements for telephonic visits diminished or ceased. Opportunities to enhance future efforts include a need to provide additional guidance supporting telemedicine use cases and evidence of effectiveness in oncology care and to address provider concerns with communication quality. In a setting of decentralized care processes, early challenges in telemedicine implementation had an outsized impact on the nature and amount of sustained use. Proactively designed telemedicine care processes with attention to patient needs will be essential to support a sustained role for telemedicine in cancer care.

Lumbar spinal stenosis is the most common reason for spinal surgery in patients over the age of 65 years. This randomized clinical trial compared surgical decompression with nonsurgical therapy for spinal stenosis without spondylolisthesis. Although the trial was limited by frequent crossover between the two randomized groups and therefore was not definitive, the findings favored surgical decompression over nonsurgical care for this common spine disorder. This trial compared surgical decompression with nonsurgical therapy for spinal stenosis without spondylolisthesis. The findings favored surgical decompression over nonsurgical care for this common spine disorder. Spinal stenosis is a narrowing of the spinal canal with encroachment on the neural structures by surrounding bone and soft tissue. Patients typically present with radicular leg pain or with neurogenic claudication (pain in the buttocks or legs on walking or standing that resolves with sitting down or lumbar flexion). Spinal stenosis is the most common reason for lumbar spine surgery in adults over the age of 65 years. 1 , 2 Indications for surgery appear to vary widely, and rates of procedures vary by at least a factor of 5 across geographic areas. 3 , 4 Radiographic evidence of stenosis is frequently asymptomatic; . . .

Near-infrared spectroscopic tomography was used to measure the properties of 24 mammographically normal breasts to quantify whole-breast absorption and scattering spectra and to evaluate which tissue composition characteristics can be determined from these spectra. The absorption spectrum of breast tissue allows quantification of (i) total hemoglobin concentration, (ii) hemoglobin oxygen saturation, and (iii) water concentration, whereas the scattering spectrum provides information about the size and number density of cellular components and structural matrix elements. These property data were tested for correlation to demographic information, including subject age, body mass index, breast size, and radiographic density. Total hemoglobin concentration correlated inversely to body mass index, likely because lower body mass indicates proportionately less fat and more glandular tissue, and glandular tissue contains greater vascularity, hence, more total hemoglobin. Optical scattering was correlated to breast diameter, subject age, and radiographic density. In the radiographic density, fatty breasts had low scattering power and extremely dense breasts had higher values. This observation is consistent with low attenuation of conventional x-rays with fat and higher attenuation in glandular tissues. Optically, fatty tissues have large scatterers leading to a low scattering power, whereas glandular or fibrous tissues have more cellular and collagen-based structures that lead to high scattering power. The study presents correlative data supporting the hypothesis that optical measurements of absorption and scattering can provide physiologically relevant information about breast tissue composition. These breast constituents vary significantly between individuals and can be altered because of changes in breast physiology or pathological state.

Targeted therapies such as the Bruton's tyrosine kinase (BTK) inhibitor ibrutinib are better tolerated and have become standard of care for CLL. TABLE 1 Patient demographics and outcomes Patient demographic All cohorts n = 6 Cohort 1 (8 mg/m2) n = 3 Cohort 2 (12 mg/m2) n = 3 a Sex Male 5 2 3 Female 1 1 0 Age Median (range) 72 (52–75) 71 (52–75) 73 (60–75) <65 y 2 1 1 ≥65 y 4 2 2 BMI Median (range) 31.0 (21.2–38.2) 26.5 (21.2–32.9) 32.1 (29.9–38.2) Race White 6 (100%) 3 (100%) 3 (100%) Ethnicity Other (non-Hispanic/Latino) 6 (100%) 3 (100%) 3 (100%) ECOG score 0 1 (16.7%) 1 (33.3%) 0 (0%) 1 5 (83.3%) 2 (66.7%) 3 (100%) Years since diagnosis Median (range) 9.5 (8–12) 9 (8–12) 10 (9–10) Prior therapies Median (range) 2.5 (1–8) 2 (1–8) 3 (2–3) Prior ibrutinib 2 1 1 Patient outcomes # Cycles completed Median (range) 4.9 (1.7–6) 4.5 (2–5.3) 6 (1.7–6) # Days on study Median (range) 128 (49–178) 104 (100–154) 152 (49–178) Adverse events Median (range) 6 (2–12) 6 (6–12) 8 (2–12) Serious adverse events Total 2 1 b 1 a, c Dose limiting toxicity Total 1 0 1 Best response achieved d PR 1 a 0 1 SD 3 2 1 NE 2 1 1 a One patient initially received BNC105P 12 mg/m2 monotherapy in cycle 1 and ibrutinib 420 mg monotherapy in cycle 2 (days 1–7) but because of a 25%–50% drop in platelets from baseline (from Gr1 →Gr2) was dose reduced to 8 mg/m2 BNC105P and ibrutinib 280 mg daily (as proscribed in the protocol but not a defining DLT) and subsequently tolerated this dose for six cycles with a partial remission. b This SAE was a patient who developed cryptococcal pneumonia following heavy self-exposure to bat droppings (guano) while cleaning an attic. The SAE occurred on study cycle 3 day 7, which was outside the defined DLT time window for the study. c This SAE was sudden death (of unknown cause; no autopsy) of the patient described in footnote a who completed six cycles of 8 mg/m2 BNC105P + Ibrutinib 280 mg daily and was off combination study treatment and being treated only with ibrutinib monotherapy when the SAE occurred. d BMI, body mass index; ECOG, Eastern Cooperative Group; NE, not evaluable; PR, partial remission; SD, stable disease. Two SAEs occurred: one sudden death (unknown cause) occurred 10 days after completing study combination treatment while receiving ibrutinib monotherapy; one patient in cohort 1 developed cryptococcal pneumonia on C3D7 following heavy exposure to bat droppings (guano) at a timepoint beyond the defined DLT time window.

Research articles in the clinical and translational science literature commonly use quantitative data to inform evaluation of interventions, learn about the etiology of disease, or develop methods for diagnostic testing or risk prediction of future events. The peer review process must evaluate the methodology used therein, including use of quantitative statistical methods. In this manuscript, we provide guidance for peer reviewers tasked with assessing quantitative methodology, intended to complement guidelines and recommendations that exist for manuscript authors. We describe components of clinical and translational science research manuscripts that require assessment including study design and hypothesis evaluation, sampling and data acquisition, interventions (for studies that include an intervention), measurement of data, statistical analysis methods, presentation of the study results, and interpretation of the study results. For each component, we describe what reviewers should look for and assess; how reviewers should provide helpful comments for fixable errors or omissions; and how reviewers should communicate uncorrectable and irreparable errors. We then discuss the critical concepts of transparency and acceptance/revision guidelines when communicating with responsible journal editors.

This clinical trial compared surgical treatment with nonsurgical treatment of spondylolisthesis. Because of extensive patient crossover, the data were essentially nonrandomized, and as-treated analyses were performed. During 2 years of follow-up, patients treated surgically had greater improvement in pain and function than those treated nonsurgically. Patients treated nonsurgically showed moderate improvement over time. This clinical trial compared surgical treatment with nonsurgical treatment of spondylolisthesis. During 2 years of follow-up, patients treated surgically had greater improvement in pain and function than those treated nonsurgically. Degenerative spondylolisthesis is the slipping forward of one lumbar vertebra on another with an intact neural arch. It rarely occurs before the age of 50 years, and it disproportionately affects women, particularly black women, with a male:female ratio of approximately 1:6. 1 Slippage most commonly occurs at the L4–L5 level and rarely exceeds 30% of vertebral width. 1 Degenerative spondylolisthesis is generally asymptomatic, but it can be associated with symptomatic spinal stenosis. 1 Spinal stenosis, the most common reason for lumbar surgery in adults over the age of 65, is a narrowing of the spinal canal with encroachment on the neural structures by . . .

Objective: Arsenic is a known bladder carcinogen and populations exposed to high arsenic levels in their water supply have reported elevated bladder cancer mortality and incidence rates. To examine the effects of lower levels of arsenic exposure on bladder cancer incidence, we conducted a case-control study in New Hampshire, USA where levels above 10 μ/l are commonly found in private wells. Methods: We studied 383 cases of transitional cell carcinoma of the bladder cancer, newly diagnosed between July 1, 1994 and June 30, 1998 and 641 general population controls. Individual exposure to arsenic was determined in toenail clippings using instrumental neutron activation analysis. Results: Among smokers, an elevated odds ratio (OR) for bladder cancer was observed for the uppermost category of arsenic (OR: 2.17, 95% CI: 0.92-5.11 for greater than 0.330 mcg/g compared to less than 0.06 μ/g). Among never smokers, there was no association between arsenic and bladder cancer risk. Conclusions: These, and other data, suggest that ingestion of low to moderate arsenic levels may affect bladder cancer incidence, and that cigarette smoking may act as a co-carcinogen.

Rigorous scientific review of research protocols is critical to making funding decisions, and to the protection of both human and non-human research participants. Given the increasing complexity of research designs and data analysis methods, quantitative experts, such as biostatisticians, play an essential role in evaluating the rigor and reproducibility of proposed methods. However, there is a common misconception that a statistician’s input is relevant only to sample size/power and statistical analysis sections of a protocol. The comprehensive nature of a biostatistical review coupled with limited guidance on key components of protocol review motived this work. Members of the Biostatistics, Epidemiology, and Research Design Special Interest Group of the Association for Clinical and Translational Science used a consensus approach to identify the elements of research protocols that a biostatistician should consider in a review, and provide specific guidance on how each element should be reviewed. We present the resulting review framework as an educational tool and guideline for biostatisticians navigating review boards and panels. We briefly describe the approach to developing the framework, and we provide a comprehensive checklist and guidance on review of each protocol element. We posit that the biostatistical reviewer, through their breadth of engagement across multiple disciplines and experience with a range of research designs, can and should contribute significantly beyond review of the statistical analysis plan and sample size justification. Through careful scientific review, we hope to prevent excess resource expenditure and risk to humans and animals on poorly planned studies.

PurposeIn the genomic era, more women with low-risk breast cancer will forego chemotherapy and rely on adjuvant endocrine therapy (AET) to prevent metastatic recurrence. However, some of these patients will unfortunately relapse. We sought to understand this outcome. Preliminary work suggested that early discontinuation of AET, also known as non-persistence, may play an important role. A retrospective analysis exploring factors related to our breast cancer patients’ non-persistence with AET was performed. MethodsWomen who underwent Oncotype-DX® testing between 2011 and 2014 with minimum 5 years follow-up were included. ‘Low risk’ was defined as Oncotype score < 26. Outcomes of recurrence and persistence were determined by chart review. Patient, tumor and treatment factors were collected, and persistent versus non-persistent groups compared using multivariable ANOVA and Fisher Chi square exact test.ResultsWe identified six cases of distant recurrence among low-risk patients with a median follow-up of 7.7 years. Among them, five of six patients (83%) were non-persistent with AET. The non-persistence rate in our cohort regardless of recurrence was 57/228 (25%). Non-persistent patients reported more severe side effects compared with persistent patients (p = 0.002) and were more likely to be offered a switch in endocrine therapy, rather than symptom-relief (p = 0.006). In contrast, persistent patients were 10.3 times more likely to have been offered symptom-alleviating medications compared with non-persistent patients (p < 0.001). A subset analysis revealed that patients who persisted with therapy had a higher Oncotype-DX® score than patients who discontinued early (p = 0.028).ConclusionMetastatic recurrence in low-risk breast cancer patients may be primarily due to non-persistence with endocrine therapy. Further work is needed to optimize care for patients who struggle with side effects. To our knowledge, these are the first published data suggesting that Oncotype-DX® score may influence persistence with AET.