Centralized Quality Assurance of Stereotactic Body Radiation Therapy for the Veterans Affairs Cooperative Studies Program Study Number 2005: A Phase 3 Randomized Trial of Lung Cancer Surgery or Stereotactic Radiotherapy for Operable Early-Stage Non-Small Cell Lung Cancer (VALOR).

PURPOSE: The phase 3 Veterans Affairs Lung Cancer Surgery Or Stereotactic Radiotherapy study implemented centralized quality assurance (QA) to mitigate risks of protocol deviations. This report summarizes the quality and compliance of the first 100 participants treated with stereotactic body radiation therapy (SBRT) in this study. METHODS AND MATERIALS: A centralized QA program was developed to credential and monitor study sites to ensure standard-of-care lung SBRT treatments are delivered to participants. Requirements were adapted from protocols established by the National Cancer Institute's Image and Radiation Oncology Core, which provides oversight for clinical trials sponsored by the National Cancer Institute's National Clinical Trials Network. RESULTS: The first 100 lung SBRT treatment plans were reviewed from April 2017 to October 2022. Tumor contours were appropriate in all submissions. Planning target volume (PTV) expansions were less than the minimum 5 mm requirement in 2% of cases. Critical organ-at-risk structures were contoured accurately for the proximal bronchial tree, trachea, esophagus, spinal cord, and brachial plexus in 75%, 92%, 100%, 100%, and 95% of cases, respectively. Prescriptions were appropriate in 98% of cases; 2 central tumors were treated using a peripheral tumor dose prescription while meeting organ-at-risk constraints. PTV V100% (the percentage of target volume that receives 100% or more of the prescription) values were above the protocol-defined minimum of 94% in all but 1 submission. The median dose maximum (Dmax) within the PTV was 125.4% (105.8%-149.0%; SD ± 8.7%), where values reference the percentage of the prescription dose. High-dose conformality (ratio of the volume of the prescription isodose to the volume of the PTV) and intermediate-dose compactness [R50% (ratio of the volume of the half prescription isodose to the volume of the PTV) and D2cm (the maximum dose beyond a 2 cm expansion of the PTV expressed as a percentage of the prescription dose)] were acceptable or deviation acceptable in 100% and 94% of cases, respectively. CONCLUSIONS: The first 100 participants randomized to SBRT in this study were appropriately treated without safety concerns. A response to the incorrect prescriptions led to preventative measures without further recurrences. The program was developed in a health care system without prior experience with a centralized radiation therapy QA program and may serve as a reference for other institutions.

Challenges and Opportunities in Developing an Oncology Clinical Trial Network in the United States Veterans Affairs Health Care System: The VA STARPORT Experience.

The United States Veterans Affairs (VA) Health Care System has a strong history of conducting impactful oncology randomized clinical trials (RCTs). We developed a phase II/III RCT to test the use of metastasis-directed therapy in Veterans with oligometastatic prostate cancer (OMPC)-the first VA RCT in OMPC that leverages novel imaging and advanced radiotherapy techniques. To accomplish this, we developed a clinical trial network to conduct the study. In this manuscript, we describe several challenges we encountered in study development/conduct and our strategies to address them, with the goal of helping investigators establish robust study networks to conduct clinical trials. In the study start-up, we encountered challenges in timely site activation, and leveraged project management to maximize efficiency. Additionally, there were several changes in the clinical paradigms in imaging and treatment that led to protocol amendments to ensure maximum equipoise, recruitment, and impact of the study. Specifically, we amended the trial to add de novo OMPC patients (from initially only recurrent OMPC) and expanded the study to allow up to 10 metastases (from initially five). Finally, in order to maintain local study team engagement, we developed initiatives to maximize collaboration and add value to the overall clinical program through study participation.

Effect of Pulsed Low-Intensity Ultrasonography on Symptom Relief and Tibiofemoral Articular Cartilage Thickness Among Veterans Affairs Enrollees With Knee Osteoarthritis: A Randomized Clinical Trial.

Importance: Osteoarthritis (OA) is a major cause of disability in the US, with no approved treatments to slow progression, but animal models suggest that pulsed low-intensity ultrasonography (PLIUS) may promote cartilage growth. Objective: To evaluate the efficacy of PLIUS in providing symptom reduction and decreased loss of tibiofemoral cartilage thickness in patients with knee OA. Design, Setting, and Participants: A phase 2A, sham-controlled, parallel, double-blind randomized clinical trial was conducted at 2 Veterans Affairs hospitals in Salt Lake City, Utah, and San Diego, California, from May 22, 2015, to January 31, 2019. Data were analyzed from June 27, 2020, to October 20, 2020. Participants recruited through the US Department of Veterans Affairs (N = 132) with clinical and radiographic evidence of early knee OA were randomly assigned to receive PLIUS or a sham device, self-administered for 20 minutes daily over the medial compartment of the knee. All enrollees participated in a 4-week prerandomization sham run-in period, followed by a 48-week treatment period. Randomization was stratified by study site and Kellgren-Lawrence grades 1 (n = 15), 2 (n = 51), and 3 (n = 66). Intervention: Participants either received 48 weeks of PLIUS or sham ultrasonography. Main Outcomes and Measures: The trial incorporated 2 coprimary outcomes: symptomatic improvement assessed by Outcome Measures in Rheumatology Clinical Trials-Osteoarthritis Research Society International Responder Criteria (ie, met if either >50% improvement in pain and function with at least a 20% absolute improvement of at least 2 of the following 3 factors: improvement by at least 20% [pain, function, and patient global assessment] with at least a 10-mm absolute improvement), and cartilage preservation assessed as change in central medial femoral condyle cartilage thickness by magnetic resonance imaging. Intention-to-treat analysis was used. Results: The mean (SD) participant age was 63.6 (10.7) years and 119 were men (90.2%). The mean (SD) duration of OA symptoms was 13.4 (12.3) years. In the PLIUS group, 70.4% (95% CI, 58.2%-82.6%) of the participants experienced symptomatic improvement, compared with 67.3% (95% CI, 54.9%-79.7%) of participants in the sham group (P = .84); there was no statistically significant difference in response rates between the treatment groups, and the between-group rate difference of 3.1% (95% CI, -14.3% to 20.5%) did not meet the predefined 10% threshold for clinically significant symptomatic improvement from application of PLIUS. At 48 weeks of treatment, central medial femoral condyle cartilage thickness decreased by a mean (SD) of 73.8 (168.1) µm in the PLIUS group and by 42.2 (297.0) µm in the sham group. This 48-week mean change between the 2 groups did not reach statistical significance (P = .44), and the between-group 48-week difference of -31.7 µm (95% CI, -129.0 µm to 65.7 µm) did not meet the predefined threshold. There were 99 nonserious adverse events in the PLIUS group and 89 in the sham group during the trial. No serious adverse events were deemed related to the study device. Conclusions and Relevance: PLIUS, as implemented in this study, demonstrated neither symptomatic benefit nor a decrease in loss of tibiofemoral cartilage thickness in knee OA. Trial Registration: ClinicalTrials.gov Identifier: NCT02034409.

Physician survey examining the impact of an educational tool for responsible opioid prescribing.

INTRODUCTION: In response to the need for physician education on proper opioid prescribing, the Federation of State Medical Boards (FSMB) and the FSMB Foundation, the philanthropic arm of the FSMB, commissioned and distributed Responsible Opioid Use: A Physician's Guide to more than 165, 000 licensed physicians in the United States. The book, written by pain management specialist Scott Fishman, MD, seeks tofurtherphysicians' continuing medical education by providing information on how to properly prescribe opioids to treat patients in pain. Although the book has been widely distributed, there have been no systematic studies of its impact. To address this knowledge gap, the authors surveyed licensed physicians in Georgia who received a copy of the book to determine whether it added to their knowledge about prescribing opioids, and if they planned to make changes in theirpractice based on reading the book. METHODS: Six weeks after licensed physicians in Georgia received the book, a survey was sent to 12,666 of them via e-mail. RESULTS: A total of508 physicians completed the online survey. Of these, 82.1 percent rated the book either "very good" or "good" on providing pragmatic steps for improved care forpatients in pain, and more than 80 percent agreed that the book is a useful educational tool. Almost one-third (32.2percent) claimed that they intend to make changes to theirpractice after reading the book. The analysis also showed physicians in a solo practice were more likely to make changes (41.8percent) than their counterparts in office-based group practice (33.3 percent) and hospital-based (25.0 percent) settings. Primary care providers (41.6 percent) were also much more likely to make changes than physicians working in other specialty areas of medicine (22.8 percent). Well over half (57. 7percent) of the respondents indicated the book was better than other publications they had read on opioid prescribing and pain management. CONCLUSIONS: The results from this state-wide survey of licensed physicians demonstrate the value of educating physicians about how to appropriately prescribe, document, and treat patients who need opioid medications for pain management. The findings should be of value to organizations seeking to better educate physicians about appropriate opioid prescribing by providing insight into which physician population would be the most receptive to the type of information presented in Dr. Fishman's book. When faced with limited resources, an organizational strategy that first targets solo and primary care practitioners may improve physician educational efforts about prescribing opioids better than a strategy targeting medical and surgical specialists or those physicians participating in group practice settings.

Predictors of responses to psychotherapy referral of WTC utility disaster workers.

This study examined male utility disaster workers' responses to referral for trauma-specific psychotherapy. Among 328 workers offered referral for symptoms related to the World Trade Center (WTC) attacks during psychological screening, approximately 48% chose to accept, 28% chose to consider only, and 24% chose to decline. Analyses examined predisposing factors, i.e., age, race/ethnicity, marital status, education, previous mental health treatment, and previous disorder; as well as illness level; i.e., posttraumatic stress disorder (PTSD), depression, and general psychiatric distress; current treatment; and time of referral as predictors of referral response. PTSD (specifically reexperiencing and hyperarousal symptoms), depressive symptoms, and previous mental health treatment were positively associated with workers' accepting referral. Implications and limitations of these findings are discussed.