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Introduction: The National Comprehensive Cancer Network and the American Cancer Society recently released lung screening guidelines that include smoking cessation counseling for smokers undergoing screening. Previous work indicates that smoking behaviors and risk perceptions of the National Lung Screening Trial (NLST) participants were relatively unchanged. We explored American College of Radiology Imaging Network (ACRIN)/NLST former and current smokers’ risk perceptions specifically to (a) determine whether lung screening is a cue for behavior change, (b) elucidate risk perceptions for lung cancer and smoking-related diseases, and (c) explore postscreening behavioral intentions and changes. Methods: A random sample of 35 participants from 4 ACRIN sites were qualitatively interviewed 1–2 years postscreen. We used a structured interview guide based on Health Belief Model and Self-Regulation Model constructs. Content analyses were conducted with NVivo 8. Results: Most participants endorsed high-risk perceptions for lung cancer and smoking-related diseases, but heightened concern about these risks did not appear to motivate participants to seek screening. Risk perceptions were mostly attributed to participants’ heavy smoking histories; former smokers expressed greatly reduced risk. Lung cancer and smoking-related diseases were perceived as very severe although participants endorsed low worry. Current smokers had low confidence in their ability to quit, and none reported quitting following their initial screen. Conclusions: Lung screening did not appear to be a behavior change cue to action, and high-risk perceptions did not translate into quitting behaviors. Cognitive and emotional dissonance and avoidance strategies may deter engagement in smoking behavior change. Smoking cessation and prevention interventions during lung screening should explore risk perceptions, emotions, and quit confidence. [ABSTRACT FROM PUBLISHER]

Background: Positron emission tomography (PET) performed during cancer therapy (treatment monitoring) has shown promise for predicting treatment outcome. However, when used for this purpose, PET generally is not considered standard care. Under the Medicare 'coverage with evidence development' policy, PET (and integrated PET/computed tomography) became a covered service for treatment monitoring if prospective registry data were collected. Methods: The National Oncologic PET Registry collected questionnaire data on intended patient management before and after PET. Data were available from 8240 patients who had 10,497 treatment-monitoring PET scans at 946 centers; these studies were used to monitor chemotherapy alone (82%), radiation therapy alone (6%), or combined-modality treatment (12%). Ovarian, pancreatic, and lung cancers accounted for 37% of the cohort. In 54% of scans, the pre-PET summary stage was metastatic disease. Results: If PET had not been available, then the pre-PET plan would have been other imaging (53%), ongoing treatment (41%), or biopsy or watching (6%). Change in the post-PET intended management was similar in the imaging and treatment groups: 26% to 28% of scans to switching to another therapy, and 16% to 19% scans led to adjustment of the dose or duration of therapy. Changes in management were more frequent if the referring physician judged that the post-PET prognosis was worse rather than improved or unchanged (78% vs 40%). The physicians indicated that PET enabled 91% of their patients to avoid future tests. Conclusions: Physicians often report plans to modify their therapeutic plans in elderly cancer patients when PET is used for treatment monitoring. [ABSTRACT FROM AUTHOR]

We review knowledge on #socialgenomics in #oncology and discuss the opportunity for application in #AYA oncology research. #AYACSM [ABSTRACT FROM AUTHOR]

Background: Enthusiasm for precision oncology may obscure the psychosocial and ethical considerations associated with the implementation of tumor genetic sequencing. Methods: Patients with advanced cancer undergoing tumor‐only genetic sequencing in the National Cancer Institute Molecular Analysis for Therapy Choice (MATCH) trial were randomized to a web‐based genetic education intervention or usual care. The primary outcomes were knowledge, anxiety, depression, and cancer‐specific distress collected at baseline (T0), posteducation (T1) and after results (T2). Two‐sided, 2‐sample t tests and univariate and multivariable generalized linear models were used. Results: Five hundred ninety‐four patients (80% from NCI Community Oncology Research Program sites) were randomized to the web intervention (n = 293) or usual care (n = 301) before the receipt of results. Patients in the intervention arm had greater increases in knowledge (P for T1‐T0 <.0001; P for T2‐T0 =.003), but there were no significant differences in distress outcomes. In unadjusted moderator analyses, there was a decrease in cancer‐specific distress among women (T0‐T1) in the intervention arm but not among men. Patients with lower health literacy in the intervention arm had greater increases in cancer‐specific distress and less decline in general anxiety (T0‐T1) and greater increases in depression (T0‐T2) in comparison with those receiving usual care. Conclusions: Web‐based genetic education before tumor‐only sequencing results increases patient understanding and reduces distress in women. Refinements to the intervention could benefit low‐literacy groups and men. In the Communication and Education in Tumor Profiling (COMET) study, patients with advanced cancer undergoing tumor genetic sequencing in the National Cancer Institute Molecular Analysis for Therapy Choice (MATCH) trial have been randomized to a web‐based genetic education intervention or usual care. Web‐based genetic education has resulted in increased patient understanding and reduced distress in female patients with cancer. [ABSTRACT FROM AUTHOR]

Background: TAILORx (Trial Assigning Individualized Options for Treatment) prospectively assessed fatigue and endocrine symptoms among women with early‐stage hormone receptor–positive breast cancer and a midrange risk of recurrence who were randomized to endocrine therapy (E) or chemotherapy followed by endocrine therapy (CT+E). Methods: Participants completed the Functional Assessment of Chronic Illness Therapy–Fatigue, the Patient‐Reported Outcomes Measurement Information System–Fatigue Short Form, and the Functional Assessment of Cancer Therapy–Endocrine Symptoms at the baseline and at 3, 6, 12, 24, and 36 months. Linear regression was used to model outcomes on baseline symptoms, treatment, and other factors. Results: Participants (n = 458) in both treatment arms reported greater fatigue and endocrine symptoms at early follow‐up in comparison with the baseline. The magnitude of change in fatigue was significantly greater for the CT+E arm than the E arm at 3 and 6 months but not at 12, 24, or 36 months. The CT+E arm reported significantly greater changes in endocrine symptoms from the baseline to 3 months in comparison with the E arm; change scores were not significantly different at later time points. Endocrine symptom trajectories by treatment differed by menopausal status, with the effect larger and increasing for postmenopausal patients. Conclusions: Adjuvant CT+E was associated with greater increases in fatigue and endocrine symptoms at early time points in comparison with E. These differences lessened over time, and this demonstrated early chemotherapy effects more than long‐term ones. Treatment arm differences in endocrine symptoms were more evident in postmenopausal patients. Lay Summary: Participants in TAILORx (Trial Assigning Individualized Options for Treatment) with early‐stage hormone receptor–positive breast cancer and an intermediate risk of recurrence were randomly assigned to endocrine or chemoendocrine therapy.Four hundred fifty‐eight women reported fatigue and endocrine symptoms at the baseline and at 3, 6, 12, 24, and 36 months.Both groups reported greater symptoms at early follow‐up versus the baseline.Increases in fatigue were greater for the chemoendocrine group than the endocrine group at 3 and 6 months but not later.The chemoendocrine group reported greater changes in endocrine symptoms in comparison with the endocrine group at 3 months but not later. Participants in TAILORx (Trial Assigning Individualized Options for Treatment) randomized to chemoendocrine therapy report significant increases in fatigue and endocrine symptoms 3 months after randomization, which decrease through 36 months. Those randomized to endocrine therapy also report increased symptoms from the baseline, although of a lesser magnitude. [ABSTRACT FROM AUTHOR]

Background: E5103 was a study designed to evaluate the efficacy and safety of bevacizumab. It was a negative trial for the end points of invasive disease–free survival and overall survival. The current work examines the tolerability of bevacizumab and other medication exposures with respect to clinical outcomes and patient‐reported outcomes (PROs). Methods: Adverse events (AEs) collected from the Common Terminology Criteria for Adverse Events were summarized to form an AE profile at each treatment cycle. All‐grade and high‐grade events were separately analyzed. The change in the AE profile over the treatment cycle was delineated as distinct AE trajectory clusters. AE‐related and any‐reason early treatment discontinuations were treated as clinical outcome measures. PROs were measured with the Functional Assessment of Cancer Therapy–Breast + Lymphedema. The relationships between the AE trajectory and early treatment discontinuation as well as PROs were analyzed. Results: More than half of all AEs (57.5%) were low‐grade. A cluster of patients with broad and mixed AE (all‐grade) trajectory grades was significantly associated with any‐reason early treatment discontinuation (odds ratio [OR], 2.87; P =.01) as well as AE‐related discontinuation (OR, 4.14; P =.001). This cluster had the highest count of all‐grade AEs per cycle in comparison with other clusters. Another cluster of patients with primary neuropathic AEs in their trajectories had poorer physical well‐being in comparison with a trajectory of no or few AEs (P <.01). A high‐grade AE trajectory did not predict discontinuations. Conclusions: A sustained and cumulative burden of across‐the‐board toxicities, which were not necessarily all recognized as high‐grade AEs, contributed to early treatment discontinuation. Patients with neuropathic all‐grade AEs may require additional attention for preventing deterioration in their physical well‐being. In this secondary data analysis study of patients with breast cancer treated with bevacizumab and chemotherapy, cumulative multiple toxicities, even of low grades, are associated with early treatment discontinuation. Peripheral neuropathy is related to poor self‐reported physical well‐being, and this suggests additional care for patients exhibiting such toxicity. [ABSTRACT FROM AUTHOR]

Importance: Improved screening methods for women with dense breasts are needed because of their increased risk of breast cancer and of failed early diagnosis by screening mammography.Objective: To compare the screening performance of abbreviated breast magnetic resonance imaging (MRI) and digital breast tomosynthesis (DBT) in women with dense breasts.Design, Setting, and Participants: Cross-sectional study with longitudinal follow-up at 48 academic, community hospital, and private practice sites in the United States and Germany, conducted between December 2016 and November 2017 among average-risk women aged 40 to 75 years with heterogeneously dense or extremely dense breasts undergoing routine screening. Follow-up ascertainment of cancer diagnoses was complete through September 12, 2019.Exposures: All women underwent screening by both DBT and abbreviated breast MRI, performed in randomized order and read independently to avoid interpretation bias.Main Outcomes and Measures: The primary end point was the invasive cancer detection rate. Secondary outcomes included sensitivity, specificity, additional imaging recommendation rate, and positive predictive value (PPV) of biopsy, using invasive cancer and ductal carcinoma in situ (DCIS) to define a positive reference standard. All outcomes are reported at the participant level. Pathology of core or surgical biopsy was the reference standard for cancer detection rate and PPV; interval cancers reported until the next annual screen were included in the reference standard for sensitivity and specificity.Results: Among 1516 enrolled women, 1444 (median age, 54 [range, 40-75] years) completed both examinations and were included in the analysis. The reference standard was positive for invasive cancer with or without DCIS in 17 women and for DCIS alone in another 6. No interval cancers were observed during follow-up. Abbreviated breast MRI detected all 17 women with invasive cancer and 5 of 6 women with DCIS. Digital breast tomosynthesis detected 7 of 17 women with invasive cancer and 2 of 6 women with DCIS. The invasive cancer detection rate was 11.8 (95% CI, 7.4-18.8) per 1000 women for abbreviated breast MRI vs 4.8 (95% CI, 2.4-10.0) per 1000 women for DBT, a difference of 7 (95% CI, 2.2-11.6) per 1000 women (exact McNemar P = .002). For detection of invasive cancer and DCIS, sensitivity was 95.7% (95% CI, 79.0%-99.2%) with abbreviated breast MRI vs 39.1% (95% CI, 22.2%-59.2%) with DBT (P = .001) and specificity was 86.7% (95% CI, 84.8%-88.4%) vs 97.4% (95% CI, 96.5%-98.1%), respectively (P < .001). The additional imaging recommendation rate was 7.5% (95% CI, 6.2%-9.0%) with abbreviated breast MRI vs 10.1% (95% CI, 8.7%-11.8%) with DBT (P = .02) and the PPV was 19.6% (95% CI, 13.2%-28.2%) vs 31.0% (95% CI, 17.0%-49.7%), respectively (P = .15).Conclusions and Relevance: Among women with dense breasts undergoing screening, abbreviated breast MRI, compared with DBT, was associated with a significantly higher rate of invasive breast cancer detection. Further research is needed to better understand the relationship between screening methods and clinical outcome.Trial Registration: ClinicalTrials.gov Identifier: NCT02933489. [ABSTRACT FROM AUTHOR]

Objectives: It is unclear if a low- or high-volume IV fluid resuscitation strategy is better for patients with severe sepsis and septic shock.Design: Prospective randomized controlled trial.Setting: Two adult acute care hospitals within a single academic system.Patients: Patients with severe sepsis and septic shock admitted from the emergency department to the ICU from November 2016 to February 2018.Interventions: Patients were randomly assigned to a restrictive IV fluid resuscitation strategy (≤ 60 mL/kg of IV fluid) or usual care for the first 72 hours of care.Measurements and Main Results: We enrolled 109 patients, of whom 55 were assigned to the restrictive resuscitation group and 54 to the usual care group. The restrictive group received significantly less resuscitative IV fluid than the usual care group (47.1 vs 61.1 mL/kg; p = 0.01) over 72 hours. By 30 days, there were 12 deaths (21.8%) in the restrictive group and 12 deaths (22.2%) in the usual care group (odds ratio, 1.02; 95% CI, 0.41-2.53). There were no differences between groups in the rate of new organ failure, hospital or ICU length of stay, or serious adverse events.Conclusions: This pilot study demonstrates that a restrictive resuscitation strategy can successfully reduce the amount of IV fluid administered to patients with severe sepsis and septic shock compared with usual care. Although limited by the sample size, we observed no increase in mortality, organ failure, or adverse events. These findings further support that a restrictive IV fluid strategy should be explored in a larger multicenter trial. [ABSTRACT FROM AUTHOR]

Introduction: Lung screening is an opportunity for smoking cessation and relapse prevention, but smoking behaviors may differ across screening results. Changes in smoking were evaluated among 18 840 current and former smokers aged 55-74 scheduled to receive three annual lung screenings.Methods: Participants were randomized to low-dose computed tomography or single-view chest radiography in the American College of Radiology/National Lung Screening Trial. Outcome measures included point and sustained (6-month) abstinence and motivation to quit among smokers; and relapse among smokers who quit during follow-up, recent quitters (quit < 6 months), and long-term former smokers (quit ≥ 6 months).Results: During five years of follow-up, annual point prevalence quit rates ranged from 11.6%-13.4%; 48% of current smokers reported a quit attempt and 7% of long-term former smokers relapsed. Any false positive screening result was associated with subsequent increased point (multivariable hazard ratio HR = 1.23, 95% CI = 1.13, 1.35) and sustained (HR = 1.28, 95% CI = 1.15, 1.43) abstinence among smokers. Recent quitters with ≥1 false positive screen were less likely to relapse (HR = 0.72, 95% CI = 0.54, 0.96). Screening result was not associated with relapse among long-term former smokers or among baseline smokers who quit during follow-up.Conclusions: A false positive screen was associated with increased smoking cessation and less relapse among recent quitters. Consistently negative screens were not associated with greater relapse among long-term former smokers. Given the Affordable Care Act requires most health plans to cover smoking cessation and lung screening, the impact and cost-effectiveness of lung screening could be further enhanced with the addition of smoking cessation interventions. [ABSTRACT FROM AUTHOR]

The article discusses a research trial to determine whether three annual screenings (rounds TO, Tl, and T2) with low-dose helical computed tomogra-phy (CT) as compared with chest radiography could reduce mortality from lung cancer. The study conducted by the National Lung Screening Trial found that the Tl and T2 rounds, positive screening results were observed. It states that the low-dose CT was more sensitive in detecting early-stage lung cancers.

Context: Approximately 11% of cancer survivors smoke postdiagnosis., Objectives: Understanding the relationship between smoking and perceived cancer-related symptoms may inform tobacco treatment interventions for this population., Methods: From 2017 to 2021, 740 adults in 9 ECOG-ACRIN trials provided baseline data. The effects of smoking status on symptoms were evaluated using logistic regression, adjusting for age, gender, race, performance status, treatment setting, and anxiety. Fisher's exact test was used to compare the prevalence of patients reporting that smoking helps/worsens each symptom by smoking status (current vs. former)., Results: Among participants (mean age = 58.8, 93.9% white, 30.3% female, most common cancer types: leukemia [35.5%], lymphoma [19.1%], and prostate [17.7%]), smoking statuses were: 81 current (10.9%), 257 former (34.7%), and 402 (54.3%) never. Patients currently smoking were more likely to experience cough compared to those who formerly (OR = 3.25, P < .0001) or never (OR = 3.70, P < .0001) smoked. Current smoking was associated with greater severity of cough and pain and greater pain interference compared to former and never smoking (OR's > 2.26, P's < .005). Patients currently smoking were more likely to report that smoking helps with nausea (29.4% vs. 1.3%, P < .0001), insomnia (16.4% vs. 0.6%, P < .0001), and pain (16.1% vs. 2.8%, P = .002) compared to those who formerly smoked., Conclusion: Patients currently smoking report greater severity of cancer-related symptoms (i.e., cough, pain) yet were also more likely to believe that smoking helps with nausea, insomnia, and pain. Symptom management should include tobacco cessation, education on smoking and its relationship to symptoms, and strategies to reduce reliance on smoking for symptom relief., (Copyright © 2025 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.)

Introduction: Smoking cessation is important for men and women diagnosed with cancer. Oncology clinicians should encourage all patients to quit and offer resources to help them do so, following the 5As framework (Ask, Advise, Assess, Assist, and Arrange follow-up)., Method: This study tests gender differences in self-reported receipt of the 5As by an oncology provider among 306 recently-diagnosed male and female cancer patients. Receipt of praise for quitting efforts was also assessed as an indicator of empathic communication. Participants completed baseline surveys as part of a larger clinical trial focused on smoking cessation (NCT03808818), reflecting on pre-trial interactions with their oncology clinicians., Results: Most male and female patients received "Ask," "Advise," and "Assess" (i.e., asking patients if they smoke, advising them to quit, and assessing their interest in doing so), though significant gender differences emerged in receiving "Assist" and "Arrange follow-up." Women were less likely to receive assistance (e.g., medication or counseling referral; 85.25% versus 93.18%, respectively) or a follow-up appointment to discuss their progress (28.11% versus 40.91%, respectively). Approximately half of men and women were praised for their quitting efforts. In exploratory sensitivity analyses, gender differences in arrange-follow-up were attenuated when adjusting for cancer location (smoking-related or not), self-reported distress, and self-reported coping ability., Discussion: Women may be at risk for suboptimal smoking-related support during cancer care, as assistance and follow-up are essential to sustained abstinence. Clinicians should consistently deliver each of the 5As to all cancer patients who smoke, regardless of cancer type or expressed distress/coping difficulty., Implications: The current study findings add to the growing literature describing gender disparities in tobacco treatment access. Findings highlight an addressable gap in access to tobacco treatment for a group of women who have cancer. Advancements in the equitable delivery of smoking cessation counseling have the potential to improve cessation outcomes for women with cancer who smoke., (© The Author(s) 2024. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.)

Importance: There is substantial interest in capturing cancer treatment tolerability from the patient's perspective using patient-reported outcomes (PROs)., Objective: To examine whether a PRO question, item 5 from the Functional Assessment of Cancer Therapy-General General Physical Wellbeing Scale (GP5), was associated with early treatment discontinuation (ETD) due to adverse events., Design, Setting, and Participants: This prospective survey study was conducted from February to April 2023. Among participants in the ECOG-ACRIN E1A11 trial (a phase 3, parallel design trial conducted between 2013 and 2019), patients with newly diagnosed multiple myeloma were randomized to receive bortezomib (VRd) or carfilzomib (KRd) plus lenalidomide and dexamethasone as induction therapy. The GP5 item was administered at baseline (pretreatment) and at 1 month, 2.8 months, and 5.5 months postbaseline. Eligible participants included patients with newly diagnosed multiple myeloma treated at community oncology practices or academic medical centers in the US., Exposures: GP5 response options were "very much," "quite a bit," "somewhat," "a little bit," and "not at all." Responses at each assessment while undergoing treatment (1 month, 2.8 months, and 5.5 months) were categorized as high adverse event bother (ie, "very much," and "quite a bit") and low adverse event bother (ie, "somewhat," "a little bit," or "not at all"). In addition, change from baseline to each assessment while undergoing treatment was calculated and categorized as worsening by 1 response category and 2 or more response categories., Main Outcome and Measure: ETD due to adverse events (yes vs no) was analyzed using logistic regression adjusting for treatment group, performance status, gender, race, and disease stage., Results: Of the 1087 participants in the original trial, 1058 (mean [SD] age 64 [9] years; 531 receiving VrD [50.2%]; 527 receiving KRd [49.8%]) responded to item GP5 and were included in the secondary analysis. A small proportion (142 patients [13.4%]) discontinued treatment early due to AEs. For those with high adverse-effect bother, GP5 while undergoing treatment was associated with ETD at 1 month (adjusted odds ratio [aOR], 2.20; 95% CI, 1.25-3.89), 2.8 months (aOR, 3.41; 95% CI, 2.01-5.80), and 5.5 months (aOR, 4.66; 95% CI, 1.69-12.83). Worsening by 2 or more response categories on the GP5 was associated with ETD at 2.8 months (aOR, 3.02; 95% CI, 1.64-5.54) and 5.5 months (aOR, 5.49; 95% CI, 1.45-20.76)., Conclusions and Relevance: In this survey study of the E1A11 trial, worse GP5 response was associated with ETD. These findings suggest that simple assessment of adverse-effect bother while receiving treatment is an efficient way to indicate treatment tolerability and ETD risk.

Purpose: Despite defined grades of 1 to 5 for adverse events (AEs) on the basis of Common Terminology Criteria for Adverse Events criteria, mild (G1) and moderate (G2) AEs are often not reported in phase III trials. This under-reporting may inhibit our ability to understand patient toxicity burden. We analyze the relationship between the grades of AEs experienced with patient side-effect bother and treatment discontinuation ., Methods: We analyzed a phase III Eastern Cooperative Oncology Group-American College of Radiology Imaging Network trial with comprehensive AE data. The Likert response Functional Assessment of Cancer Therapy-GP5 item, "I am bothered by side effects of treatment" was used to define side-effect bother. Bayesian mixed models were used to assess the impact of G1 and G2 AE counts on patient side-effect bother and treatment discontinuation. AEs were further analyzed on the basis of symptomatology (symptomatic or asymptomatic). The results are given as odds ratios (ORs) and 95% credible interval (CrI)., Results: Each additional G1 and G2 AEs experienced during a treatment cycle increased the odds of increased self-reported patient side-effect bother by 13% (95% CrI, 1.06 to 1.21) and 35% (95% CrI, 1.19 to 1.54), respectively. Furthermore, only AEs defined as symptomatic were associated with increased side-effect bother, with asymptomatic AEs showing no association regardless of grade. Count of G2 AEs increased the odds of treatment discontinuation by 59% (95% CrI, 1.32 to 1.95), with symptomatic G2 AEs showing a stronger association (OR, 1.75; 95% CrI, 1.28 to 2.39) relative to asymptomatic G2 AEs (OR, 1.45; 95% CrI, 1.12 to 1.89)., Conclusion: Low- and moderate-grade AEs are related to increased odds of increased patient side-effect bother and treatment discontinuation, with symptomatic AEs demonstrating greater magnitude of association than asymptomatic. Our findings suggest that limiting AE capture to grade 3+ misses important contributors to treatment side-effect bother and discontinuation.

Importance: The longitudinal experience of patients is critical to the development of interventions to identify and reduce financial hardship., Objective: To evaluate financial hardship over 12 months in patients with newly diagnosed colorectal cancer (CRC) undergoing curative-intent therapy., Design, Setting, and Participants: This prospective, longitudinal cohort study was conducted between May 2018 and July 2020, with time points over 12 months. Participants included patients at National Cance Institute Community Oncology Research Program sites. Eligibility criteria included age at least 18 years, newly diagnosed stage I to III CRC, not started chemotherapy and/or radiation, treated with curative intent, and able to speak English. Data were analyzed from December 2022 through April 2023., Main Outcomes and Measures: The primary end point was financial hardship, measured using the Comprehensive Score for Financial Toxicity (COST), which assesses the psychological domain of financial hardship (range, 0-44; higher score indicates better financial well-being). Participants completed 30-minute surveys (online or paper) at baseline and 3, 6, and 12 months., Results: A total of 450 participants (mean [SD] age, 61.0 [12.0] years; 240 [53.3%] male) completed the baseline survey; 33 participants (7.3%) were Black and 379 participants (84.2%) were White, and 14 participants (3.1%) identified as Hispanic or Latino and 424 participants (94.2%) identified as neither Hispanic nor Latino. There were 192 participants (42.7%) with an annual household income of $60 000 or greater. There was an improvement in financial hardship from diagnosis to 12 months of 0.3 (95% CI, 0.2 to 0.3) points per month (P < .001). Patients with better quality of life and greater self-efficacy had less financial toxicity. Each 1-unit increase in Functional Assessment of Cancer Therapy-General (rapid version) score was associated with an increase of 0.7 (95% CI, 0.5 to 0.9) points in COST score (P < .001); each 1-unit increase in self-efficacy associated with an increase of 0.6 (95% CI, 0.2 to 1.0) points in COST score (P = .006). Patients who lived in areas with lower neighborhood socioeconomic status had greater financial toxicity. Neighborhood deprivation index was associated with a decrease of 0.3 (95% CI, -0.5 to -0.1) points in COST score (P = .009)., Conclusions and Relevance: These findings suggest that interventions for financial toxicity in cancer care should focus on counseling to improve self-efficacy and mitigate financial worry and screening for these interventions should include patients at higher risk of financial burden.

Importance: Results of amyloid positron emission tomography (PET) have been shown to change the management of patients with mild cognitive impairment (MCI) or dementia who meet Appropriate Use Criteria (AUC)., Objective: To determine if amyloid PET is associated with reduced hospitalizations and emergency department (ED) visits over 12 months in patients with MCI or dementia., Design, Setting, and Participants: This nonrandomized controlled trial analyzed participants in the Imaging Dementia-Evidence for Amyloid Scanning (IDEAS) study, an open-label, multisite, longitudinal study that enrolled participants between February 2016 and December 2017 and followed up through December 2018. These participants were recruited at 595 clinical sites that provide specialty memory care across the US. Eligible participants were Medicare beneficiaries 65 years or older with a diagnosis of MCI or dementia within the past 24 months who met published AUC for amyloid PET. Each IDEAS study participant was matched to a control Medicare beneficiary who had not undergone amyloid PET. Data analysis was conducted on December 13, 2022., Exposure: Participants underwent amyloid PET at imaging centers., Main Outcomes and Measures: The primary end points were the proportions of patients with 12-month inpatient hospital admissions and ED visits. One of 4 secondary end points was the rate of hospitalizations and rate of ED visits in participants with positive vs negative amyloid PET results. Health care use was ascertained from Medicare claims data., Results: The 2 cohorts (IDEAS study participants and controls) each comprised 12 684 adults, including 6467 females (51.0%) with a median (IQR) age of 77 (73-81) years. Over 12 months, 24.0% of the IDEAS study participants were hospitalized, compared with 25.1% of the matched control cohort, for a relative reduction of -4.49% (97.5% CI, -9.09% to 0.34%). The 12-month ED visit rates were nearly identical between the 2 cohorts (44.8% in both IDEAS study and control cohorts) for a relative reduction of -0.12% (97.5% CI, -3.19% to 3.05%). Both outcomes fell short of the prespecified effect size of 10% or greater relative reduction. Overall, 1467 of 6848 participants (21.4%) with positive amyloid PET scans were hospitalized within 12 months compared with 1081 of 4209 participants (25.7%) with negative amyloid PET scans (adjusted odds ratio, 0.83; 95% CI, 0.78-0.89)., Conclusions and Relevance: Results of this nonrandomized controlled trial showed that use of amyloid PET was not associated with a significant reduction in 12-month hospitalizations or ED visits. Rates of hospitalization were lower in patients with positive vs negative amyloid PET results.

Background: While cigarette smoking has declined among the U.S. general population, sale and use of non-cigarette alternative tobacco products (ATP; e.g., e-cigarettes, cigars) and dual use of cigarettes/ATPs are rising. Little is known about ATP use patterns in cancer survivors enrolled in clinical trials. We investigated prevalence of tobacco product use, and factors associated with past 30-day use, among patients with cancer in national trials., Methods: Cancer survivors (N = 756) enrolled in 9 ECOG-ACRIN clinical trials (2017-2021) completed a modified Cancer Patient Tobacco Use Questionnaire (C-TUQ) which assessed baseline cigarette and ATP use since cancer diagnosis and in the past 30 days., Results: Patients were on average 59 years old, 70% male, and the mean time since cancer diagnosis was 26 months. Since diagnosis, cigarettes (21%) were the most common tobacco product used, followed by smokeless tobacco use (5%), cigars (4%), and e-cigarettes (2%). In the past 30 days, 12% of patients reported smoking cigarettes, 4% cigars, 4% using smokeless tobacco, and 2% e-cigarettes. Since cancer diagnosis, 5.5% of the sample reported multiple tobacco product use, and 3.0% reported multiple product use in the past 30 days. Males (vs. females; OR 4.33; P = 0 < 0.01) and individuals not living with another person who smokes (vs. living with; OR, 8.07; P = 0 < 0.01) were more likely to use ATPs only versus cigarettes only in the past 30 days., Conclusions: Among patients with cancer, cigarettes were the most prevalent tobacco product reported., Impact: Regardless, ATPs and multiple tobacco product use should be routinely assessed in cancer care settings., (©2023 American Association for Cancer Research.)

Objective: To examine utilization patterns of diagnostic procedures after lung cancer screening among participants enrolled in the National Lung Screening Trial., Methods: Using a sample of National Lung Screening Trial participants with abstracted medical records, we assessed utilization of imaging, invasive, and surgical procedures after lung cancer screening. Missing data were imputed using multiple imputation by chained equations. For each procedure type, we examined utilization within a year after the screening or until the next screen, whichever came first, across arms (low-dose CT [LDCT] versus chest X-ray [CXR]) and by screening results. We also explored factors associated with having these procedures using multivariable negative binomial regressions., Results: After baseline screening, our sample had 176.5 and 46.7 procedures per 100 person-years for those with a false-positive and negative result, respectively. Invasive and surgical procedures were relatively infrequent. Among those who screened positive, follow-up imaging and invasive procedures were 25% and 34% less frequent in those screened with LDCT, compared with CXR. Postscreening utilization of invasive and surgical procedures was 37% and 34% lower at the first incidence screen compared with baseline. Participants with positive results at baseline were six times more likely to undergo additional imaging than those with normal findings., Discussion: Use of imaging and invasive procedures to evaluate abnormal findings varied by screening modality, with a lower rate for LDCT than CXR. Invasive and surgical workup were less prevalent after subsequent screening examinations compared with baseline screening. Utilization was associated with older age but not gender, race or ethnicity, insurance status, or income., (Copyright © 2023 American College of Radiology. Published by Elsevier Inc. All rights reserved.)

Importance: Low-dose computed tomography (LDCT) lung screening has been shown to reduce lung cancer mortality. Significant incidental findings (SIFs) have been widely reported in patients undergoing LDCT lung screening. However, the exact nature of these SIF findings has not been described., Objective: To describe SIFs reported in the LDCT arm of the National Lung Screening Trial and classify SIFs as reportable or not reportable to the referring clinician (RC) using the American College of Radiology's white papers on incidental findings., Design, Setting, and Participants: This was a retrospective case series study of 26 455 participants in the National Lung Screening Trial who underwent at least 1 screening examination with LDCT. The trial was conducted from 2002 to 2009, and data were collected at 33 US academic medical centers., Main Outcomes and Measures: Significant incident findings were defined as a final diagnosis of a negative screen result with significant abnormalities that were not suspicious for lung cancer or a positive screen result with emphysema, significant cardiovascular abnormality, or significant abnormality above or below the diaphragm., Results: Of 26 455 participants, 10 833 (41.0%) were women, the mean (SD) age was 61.4 (5.0) years, and there were 1179 (4.5%) Black, 470 (1.8%) Hispanic/Latino, and 24 123 (91.2%) White individuals. Participants were scheduled to undergo 3 screenings during the course of the trial; the present study included 75 126 LDCT screening examinations performed for 26 455 participants. A SIF was reported for 8954 (33.8%) of 26 455 participants who were screened with LDCT. Of screening tests with a SIF detected, 12 228 (89.1%) had a SIF considered reportable to the RC, with a higher proportion of reportable SIFs among those with a positive screen result for lung cancer (7632 [94.1%]) compared with those with a negative screen result (4596 [81.8%]). The most common SIFs reported included emphysema (8677 [43.0%] of 20 156 SIFs reported), coronary artery calcium (2432 [12.1%]), and masses or suspicious lesions (1493 [7.4%]). Masses included kidney (647 [3.2%]), liver (420 [2.1%]), adrenal (265 [1.3%]), and breast (161 [0.8%]) abnormalities. Classification was based on free-text comments; 2205 of 13 299 comments (16.6%) could not be classified. The hierarchical reporting of final diagnosis in NLST may have been associated with an overestimate of severe emphysema in participants with a positive screen result for lung cancer., Conclusions and Relevance: This case series study found that SIFs were commonly reported in the LDCT arm of the National Lung Screening Trial, and most of these SIFs were considered reportable to the RC and likely to require follow-up. Future screening trials should standardize SIF reporting.

Importance: Racial and ethnic groups with higher rates of clinical Alzheimer disease (AD) are underrepresented in studies of AD biomarkers, including amyloid positron emission tomography (PET)., Objective: To compare amyloid PET positivity among a diverse cohort of individuals with mild cognitive impairment (MCI) or dementia., Design, Setting, and Participants: Secondary analysis of the Imaging Dementia-Evidence for Amyloid Scanning (IDEAS), a single-arm multisite cohort study of Medicare beneficiaries who met appropriate-use criteria for amyloid PET imaging between February 2016 and September 2017 with follow-up through January 2018. Data were analyzed between April 2020 and January 2022. This study used 2 approaches: the McNemar test to compare amyloid PET positivity proportions between matched racial and ethnic groups and multivariable logistic regression to assess the odds of having a positive amyloid PET scan. IDEAS enrolled participants at 595 US dementia specialist practices. A total of 21 949 were enrolled and 4842 (22%) were excluded from the present analysis due to protocol violations, not receiving an amyloid PET scan, not having a positive or negative scan, or because of small numbers in some subgroups., Exposures: In the IDEAS study, participants underwent a single amyloid PET scan., Main Outcomes and Measures: The main outcomes were amyloid PET positivity proportions and odds., Results: Data from 17 107 individuals (321 Asian, 635 Black, 829 Hispanic, and 15 322 White) with MCI or dementia and amyloid PET were analyzed between April 2020 and January 2022. The median (range) age of participants was 75 (65-105) years; 8769 participants (51.3%) were female and 8338 (48.7%) were male. In the optimal 1:1 matching analysis (n = 3154), White participants had a greater proportion of positive amyloid PET scans compared with Asian participants (181 of 313; 57.8%; 95% CI, 52.3-63.2 vs 142 of 313; 45.4%; 95% CI, 39.9-50.9, respectively; P = .001) and Hispanic participants (482 of 780; 61.8%; 95% CI, 58.3-65.1 vs 425 of 780; 54.5%; 95% CI, 51.0-58.0, respectively; P = .003) but not Black participants (359 of 615; 58.4%; 95% CI, 54.4-62.2 vs 333 of 615; 54.1%; 95% CI, 50.2-58.0, respectively; P = .13). In the adjusted model, the odds of having a positive amyloid PET scan were lower for Asian participants (odds ratio [OR], 0.47; 95% CI, 0.37-0.59; P < .001), Black participants (OR, 0.71; 95% CI, 0.60-0.84; P < .001), and Hispanic participants (OR, 0.68; 95% CI, 0.59-0.79; P < .001) compared with White participants., Conclusions and Relevance: Racial and ethnic differences found in amyloid PET positivity among individuals with MCI and dementia in this study may indicate differences in underlying etiology of cognitive impairment and guide future treatment and prevention approaches.

The objective of this study is to examine the association between neighborhood socioeconomic status (nSES) and baseline allostatic load (AL) and clinical trial endpoints in patients enrolled in the E1A11 therapeutic trial in multiple myeloma (MM). Study endpoints were symptom burden (pain, fatigue, and bother) at baseline and 5.5 months, non-completion of induction therapy, overall survival (OS) and progression-free survival (PFS). Multivariable logistic and Cox regression examined associations between nSES, AL and patient outcomes. A 1-unit increase in baseline AL was associated with greater odds of high fatigue at baseline (adjusted OR [95% CI] = 1.21 [1.08-1.36]) and a worse OS (adjusted hazard ratio, [95% CI] = 1.21 [1.06-1.37]). High nSES was associated with worse baseline bother (middle OR = 4.22 [1.11-16.09] and high 4.49 [1.16-17.43]) compared to low nSES. There was no association between AL or nSES and symptom burden at 5.5 months, non-completion of induction therapy or PFS. Additionally, there was no association between nSES and OS. AL may have utility as a predictive marker for OS among patients with MM and may allow individualization of treatment. Future studies should standardize and validate AL patients with MM., (© 2022. The Author(s).)

Importance: Early discontinuation of adjuvant endocrine therapy (ET) is problematic among breast cancer survivors, with previous studies suggesting that up to 50% of women do not adhere to the recommended full 5 years of ET treatment., Objective: To identify the association between early discontinuation of ET in the Trial Assigning Individualized Options for Treatment (TAILORx) and modifiable risk factors, polypharmacy, and types of additional medications such as antidepressants and opioids., Design, Setting, and Participants: This post hoc analysis includes a subgroup of 954 patients with breast cancer in TAILORx, a randomized clinical trial conducted from April 7, 2006, to October 6, 2010. All participants received a diagnosis of hormone receptor-positive, ERBB2-negative, axillary node-negative breast cancer and started ET within a year of study entry. Analyses were conducted in the intent-to-treat population. Statistical analysis took place from January 15, 2020, to April 6, 2021., Main Outcomes and Measures: Participants completed measures on cancer-related health-related quality of life including physical well-being and social well-being prior to initiating ET. Early discontinuation of ET was defined as discontinuation less than 4 years from initiation for reasons other than death or recurrence. Kaplan-Meier estimates were used to calculate discontinuation, and Cox proportional hazards regression joint prediction models were used to analyze the association between rates of adherence to ET with patient-level factors., Results: A total of 954 women (mean [SD] age, 56.6 [8.9] years) were included in this analysis. In a joint model, receipt of chemoendocrine therapy (vs receipt of ET only; hazard ratio [HR], 0.57; 95% CI, 0.35-0.92; P = .02) and age older than 40 years (vs ≤40 years; HR for 41-50 years, 0.39; 95% CI, 0.18-0.85; P = .02; HR for 51-60 years, 0.28; 95% CI, 0.13-0.60; P = .001; HR for 61-70 years, 0.40; 95% CI, 0.18-0.86; P = .02; and HR for >70 years, 0.23; 95% CI, 0.07-0.77; P = .02) were associated with a lower probability of early discontinuation of ET. Adjusted for these factors, a history of depression compared with no history of depression (HR, 1.82; 95% CI, 1.19-2.77; P = .005), worse physical well-being compared with better physical well-being (HR, 2.12; 95% CI, 1.30-3.45; P = .002), and worse social well-being compared with better social well-being (HR, 1.94; 95% CI, 1.20-3.13; P = .006) were individually and significantly associated with a higher probability of early discontinuation of ET. Only antidepressant use at study baseline was associated with early discontinuation (HR, 1.87; 95% CI, 1.23-2.84; P = .003)., Conclusions and Relevance: In this post hoc analysis of a randomized clinical trial, baseline patient-reported health-related quality of life components, such as poor social well-being, poor physical well-being, and comorbid depression, were significant risk factors for early discontinuation of endocrine therapies. These results support systematic screening for patient-reported outcomes and depressive symptoms to identify women at risk for discontinuation of ET., Trial Registration: ClinicalTrials.gov Identifier: NCT00310180.

Previous work suggests that, compared to white adults, black adults have lower perceived risk for smoking-related diseases (SRDs), which may influence cessation behavior and health outcomes; however, racial differences in SRD risk perceptions among high-risk patients (i.e., a group that exhibits elevated risk for SRDs) following lung screening remain unknown. This paper thus examined differences in risk perceptions for lung cancer and other SRDs among black and white National Lung Screening Trial (NLST) participants. We administered a 10-item measure of perceived lifetime risk of lung cancer and other SRD (Smoking Risk Perceptions Scale; SRPS) to NLST participants at 1 year following lung screening to (1) establish the internal consistency of the SRPS for both black and white participants, (2) compare smoking-related disease risk perceptions between black and white participants, and (3) identify predictors of risk perceptions for black and white participants using multivariable linear regression models. We determined the SRPS items loaded onto two factors (personal and comparative risks; Cronbach's alpha = 0.93 and 0.95 for 1743 white and 194 black participants, respectively), thus demonstrating high internal consistency for both black and white adults. Compared to white participants, black adults demonstrated lower SRD risk perceptions (SRPS range = 10-50, mean difference = 2.55, SE = 0.50, p < 0.001), even after adjusting for smoking status and sociodemographics. Younger age, female gender, higher education, white race, and current smoking status were independently associated with high risk perceptions. Sociodemographic factors associated with lower risk perceptions resemble factors related to continued smoking. Findings suggest current and former black smokers are at risk of having lower risk perceptions for lung cancer and SRDs than white adults following lung cancer screening; these differences may explain observed racial differences in cessation outcomes. Although similar factors influence black and white adults' beliefs, risk perceptions may differentially impact smoking behavior among these groups. Behavior change models that guide tobacco treatment approaches, particularly for high-risk black smokers, should consider the influence of cultural factors on risk perceptions and cessation efforts.

Background: The National Lung Screening Trial (NLST) reported lung cancer and all-cause mortality reductions for low-dose computed tomography (LDCT) versus chest x-ray (CXR) screening. Although LDCT lung screening has received a grade B from the United States Preventive Services Task Force and is a covered service under most health plans, concerns remain on the costs engendered by screening, and the impact of the high rate of significant incidental finding (SIF) detection on those costs., Methods: We linked American College of Radiology Imaging Network NLST and Medicare fee-for-service claims data for participants from 23 sites for 2002-2009. We performed participant-level analyses using generalized linear regression models to estimate the adjusted annual mean of the 3-year total medical costs per person in each study arm and within screen outcome categories (ever positive with abnormalities suspicious for lung cancer, always negative for abnormalities suspicious for lung cancer, but with SIFs, and always negative without SIFs)., Results: The adjusted annual mean total per person costs were not significantly different between screening arms [LDCT, $11,029 (95% confidence interval, $10,107-$11,951); CXR, $10,905 (95% confidence interval, $10,059-$11,751)], despite higher proportions of individuals with SIFs in the LDCT versus the CXR arm (18% vs. 4%; P<0.0001)., Conclusions: We found little difference in total annual per person costs between LDCT-screened and CXR-screened Medicare participants, despite the higher number of SIFs in the LDCT arm of the study.

We have previously reported that PET using 18 F-fluoride (NaF PET) for assessment of osseous metastatic disease was associated with substantial changes in intended management in Medicare beneficiaries participating in the National Oncologic PET Registry (NOPR). Here, we use Medicare administrative data to examine the association between NaF PET results and hospice claims within 180 d and 1-y survival. Methods: We classified NOPR NaF PET results linked to Medicare claims by imaging indication (initial staging [IS]; detection of suspected first osseous metastasis [FOM]; suspected progression of osseous metastasis [POM]; or treatment monitoring [TM]) and type of cancer (prostate, lung, breast, or other). Results were classified as definitely positive scan findings versus probably positive scan findings versus negative scan findings for osseous metastasis for IS and FOM; more extensive disease versus no change or less extensive disease for POM; and worse prognosis versus no change or better prognosis for TM, based on the postscan assessment. Our study included 21,167 scans obtained from 2011 to 2014 of consenting NOPR participants aged 65 y or older. Results: The relative risk of hospice claims within 180 d of a NaF PET scan was 2.0-7.5 times higher for patients with evidence of new or progressing osseous metastasis than for those without, depending on indication and cancer type (all P < 0.008). The percentage difference in hospice claims for those with a finding of new or more advanced osseous disease ranged from 3.9% for IS prostate patients to 28% for FOM lung patients. Six-month survival was also associated with evidence of new or increased osseous disease; risk of death was 1.8-5.1 times as likely (all P ≤ 0.0001), with percentage differences of approximately 30% comparing positive and negative scans in patients with lung cancer imaged for IS or FOM. Conclusion: Our analyses demonstrated that NaF PET scan results are highly associated with subsequent hospice claims and, ultimately, with patient survival. NaF PET provides important information on the presence of osseous metastasis and prognosis to assist patients and their physicians when making decisions on whether to select palliative care and transition to hospice or whether to continue treatment., (© 2018 by the Society of Nuclear Medicine and Molecular Imaging.)

Background: Current American Cancer Society recommendations for colon cancer screening include optical colonoscopy every 10 years or computed tomography colonography (CTC) every 5 years. Bowel preparation (BP) is currently required for both screening modalities., Purpose: To compare ACRIN 6664: the National CT Colonography Trial (NCTCT) participant experiences with CTC and optical colonoscopy (OC), procedure preference, and willingness to return for each procedure., Materials and Methods: Participants from fifteen NCTCT sites, who underwent CTC followed by OC under sedation, were invited to complete questionnaires 2 weeks postexam, asking about procedure preference, physical discomfort, and embarrassment experienced and whether that discomfort and embarrassment was better or worse than expected during BP, CTC, and OC, as well as willingness to return for repeat CTC and OC at different time intervals., Results: A total of 2,310 of 2,600 patients (89%) returned their questionnaires. Of patients reporting a preference, 1,058 (46.6%) preferred CTC, 569 (25.0%) preferred OC, and 626 (27.6%) reported no preference. Participant-reported discomfort worse than expected differed significantly between CTC (32.9%) and OC (5.0%) (P<0.001). About 79.3% were willing to be screened again with CTC in 5 years, and 96.6% with OC in 10 years. Discomfort and embarrassment worse than expected with OC were associated with increased intention to adhere with CTC in the future. Conversely, embarrassment experienced during CTC and discomfort worse than expected on CTC were associated with increased intention to adhere with OC in the future., Conclusion: While a larger proportion of participants indicated that they preferred CTC to OC, willingness to undergo repeat CTC compared to OC was limited by unanticipated exam discomfort and embarrassment and CTC's shorter screening interval.

Background: The aggressive and heterogeneous nature of lung cancer has thwarted efforts to reduce mortality from this cancer through the use of screening. The advent of low-dose helical computed tomography (CT) altered the landscape of lung-cancer screening, with studies indicating that low-dose CT detects many tumors at early stages. The National Lung Screening Trial (NLST) was conducted to determine whether screening with low-dose CT could reduce mortality from lung cancer., Methods: From August 2002 through April 2004, we enrolled 53,454 persons at high risk for lung cancer at 33 U.S. medical centers. Participants were randomly assigned to undergo three annual screenings with either low-dose CT (26,722 participants) or single-view posteroanterior chest radiography (26,732). Data were collected on cases of lung cancer and deaths from lung cancer that occurred through December 31, 2009., Results: The rate of adherence to screening was more than 90%. The rate of positive screening tests was 24.2% with low-dose CT and 6.9% with radiography over all three rounds. A total of 96.4% of the positive screening results in the low-dose CT group and 94.5% in the radiography group were false positive results. The incidence of lung cancer was 645 cases per 100,000 person-years (1060 cancers) in the low-dose CT group, as compared with 572 cases per 100,000 person-years (941 cancers) in the radiography group (rate ratio, 1.13; 95% confidence interval [CI], 1.03 to 1.23). There were 247 deaths from lung cancer per 100,000 person-years in the low-dose CT group and 309 deaths per 100,000 person-years in the radiography group, representing a relative reduction in mortality from lung cancer with low-dose CT screening of 20.0% (95% CI, 6.8 to 26.7; P=0.004). The rate of death from any cause was reduced in the low-dose CT group, as compared with the radiography group, by 6.7% (95% CI, 1.2 to 13.6; P=0.02)., Conclusions: Screening with the use of low-dose CT reduces mortality from lung cancer. (Funded by the National Cancer Institute; National Lung Screening Trial ClinicalTrials.gov number, NCT00047385.).

Objective: To provide health care providers, patients, and the general public with a responsible assessment of currently available data on the management of hepatitis B., Participants: A non-DHHS, nonadvocate 12-member panel representing the fields of hepatology and liver transplantation, gastroenterology, public health and epidemiology, infectious diseases, pathology, oncology, family practice, internal medicine, and a public representative. In addition, 22 experts from pertinent fields presented data to the panel and conference audience., Evidence: Presentations by experts and a systematic review of the literature prepared by the Minnesota Evidence-based Practice Center, through the Agency for Healthcare Research and Quality. Scientific evidence was given precedence over anecdotal experience., Conference Process: The panel drafted its statement based on scientific evidence presented in open forum and on published scientific literature. The draft statement was presented on the final day of the conference and circulated to the audience for comment. The panel released a revised statement later that day at http://consensus.nih.gov. This statement is an independent report of the panel and is not a policy statement of the NIH or the Federal Government., Conclusions: The most important predictors of cirrhosis or hepatocellular carcinoma in persons who have chronic HBV are persistently elevated HBV DNA and ALT levels in blood. Other risk factors include HBV genotype C infection, male sex, older age, family history of hepatocellular carcinoma, and co-infection with HCV or HIV. The major goals of anti-HBV therapy are to prevent the development of progressive disease, specifically cirrhosis and liver failure, as well as hepatocellular carcinoma development and subsequent death. To date, no RCTs of anti-HBV therapies have demonstrated a beneficial impact on overall mortality, liver-specific mortality, or development of hepatocellular carcinoma. Most published reports of hepatitis therapy use changes in short-term virologic, biochemical, and histologic parameters to infer likelihood of long-term benefit. Approved therapies are associated with improvements in intermediate biomarkers, including HBV DNA, HBeAg loss or seroconversion, decreases in ALT levels, and improvement in liver histology (Table). Although various monitoring practices have been recommended, no clear evidence exists for an optimal approach. The most important research needs include representative prospective cohort studies to define the natural history of the disease and large RCTs of monotherapy and combined therapies, including placebo-controlled trials, that measure the effects on clinical health outcomes. Table. Criteria Useful in Determining for Whom Therapy is Indicated: Patients for whom therapy is indicated: Patients who have acute liver failure, cirrhosis and clinical complications, cirrhosis or advanced fibrosis and HBV DNA in serum, or reactivation of chronic HBV after chemotherapy or immunosuppression; Infants born to women who are HBsAg-positive (immunoglobulin and vaccination). Patients for whom therapy may be indicated: Patients in the immune-active phase who do not have advanced fibrosis or cirrhosis. Patients for whom immediate therapy is not routinely indicated: Patients with chronic hepatitis B in the immune-tolerant phase (with high levels of serum HBV DNA but normal serum ALT levels or little activity on liver biopsy); Patients in the inactive carrier or low replicative phase (with low levels of or no detectable HBV DNA in serum and normal serum ALT levels); Patients who have latent HBV infection (HBV DNA without HBsAg). We recommend routine screening for hepatitis B of newly arrived immigrants to the United States from countries where the HBV prevalence rate is greater than 2%. Screening will facilitate the provision of medical and public health services for infected patients and their families and provide public health data on the burden of disease in immigrant populations. The screening test should not be used to prohibit immigration.

The intrauterine device (IUD) has experienced a resurgence of popularity. Much of this popularity is attributable to reassessments of the association between IUD use and pelvic inflammatory disease (PID) in which authors conclude that the association is attributable to factors other than the IUD. This article examines recent studies that assess the risk of PID with IUD use, explains why some of the assumptions on which the arguments regarding a lack of an association between IUD use and PID are based might not be correct, and recommends additional trials to evaluate IUDs as one of several contraceptive options.

We evaluated the image quality of mammograms made by using a new dual-screen, dual-emulsion film combination (Kodak Min-R Fast screen, T-Mat Mll film) that permits reduction of radiation exposure by approximately 50% when compared with a standard single-screen, single-emulsion film system (Kodak Min-R screen, OM-1 film). This new film has been improved when compared with earlier T-Mat M film, including the introduction of an inert dye to reduce light crossover to essentially 0%. Mammogram pairs made with the dual-emulsion film combination and the standard single-emulsion film combination were obtained in 50 patients otherwise undergoing routine mammography. The image pairs were randomized and evaluated by three radiologists who used a three-point scale (better, same, or worse). Each pair was evaluated with regard to parenchymal contrast, sharpness, and latitude, as well as the number and sharpness of calcifications (n = 19) and sharpness of masses (n = 12) when present. All three observers found the dual-emulsion film combination to be better than or the same as the standard with regard to parenchymal sharpness (94-100%), the number and sharpness of calcifications (98-100%), and sharpness of masses (100%). Two observers found the dual-emulsion film combination to be significantly worse (p less than .05) than the standard with respect to parenchymal contrast (72%, 86%), and all three observers rated it significantly worse for film latitude (14 to 42%). Our results suggest that this new dual-emulsion film combination that allows mammography to be performed with less radiation exposure can be used without loss of image quality.