Post-trial responsibilities in pragmatic clinical trials: Fulfilling the promise of research to drive real-world change.

While considerable scholarship has explored responsibilities owed to research participants at the conclusion of explanatory clinical trials, no guidance exists regarding responsibilities owed at the conclusion of a pragmatic clinical trial (PCT). Yet post-trial responsibilities in PCTs present distinct considerations from those emphasized in existing guidance and prior scholarship. Among these considerations include the responsibilities of the healthcare delivery systems in which PCTs are embedded, and decisions about implementation for interventions that demonstrate meaningful benefit following their integration into usual care settings-or deimplementation for those that fail to do so. In this article, we present an overview of prior scholarship and guidance on post-trial responsibilities, and then identify challenges for post-trial responsibilities for PCTs. We argue that, given one of the key rationales for PCTs is that they can facilitate uptake of their results by relevant decision-makers, there should be a presumptive default that PCT study results be incorporated into future care delivery processes. Fulfilling this responsibility will require prospective planning by researchers, healthcare delivery system leaders, institutional review boards, and sponsors, so as to ensure that the knowledge gained from PCTs does, in fact, influence real-world practice.

Misuse of Prescribed and Nonprescribed Substances Among U.S. Cancer Survivors.

BACKGROUND: Substance misuse is common among cancer survivors and can negatively impact cancer outcomes. METHODS: We conducted a cross-sectional study using National Survey on Drug Use and Health data for 2015 to 2020. We included adult respondents with a history of solid tumor cancer. We calculated the weighted prevalence and corresponding SEs (both expressed as percentages) of substance (alcohol, opioid, sedative, stimulant, other) misuse for respondents with any history of solid tumor cancer and, in secondary analyses, respondents diagnosed with cancer in the prior 12 months. RESULTS: The study included 6,101 respondents with any history of cancer, 1,437 diagnosed in the prior 12 months. Alcohol was the most commonly misused substance. The average prevalence of alcohol misuse was 14.4% (SE 0.60%) across cancer types; it was markedly more common among people with a history or cervical (24.2% [3.0%]) or head and neck cancer (27.4% [7.1%]). The next most common form of substance misuse was opioid misuse (average prevalence: 2.7% [0.25%]). As with alcohol misuse, the prevalence of opioid misuse was higher among those with a lifetime history of cervical cancer (5% [1%]) or head and neck cancer (5% [3%]). Results were generally consistent among cancer survivors diagnosed in the prior 12 months. CONCLUSIONS: There is a clear opportunity to address substance misuse-particularly alcohol misuse-among cancer survivors. Such efforts should focus on populations with a high prevalence of substance misuse (e.g., cervical and head and neck cancer survivors) and have strong potential to improve cancer-specific and overall health outcomes.

HIV-1 RNA in extracellular vesicles is associated with neurocognitive outcomes.

Human immunodeficiency virus type-1 (HIV-1) is responsible for significant mortality and morbidity worldwide. Despite complete control of viral replication with antiretrovirals, cells with integrated HIV-1 provirus can produce viral transcripts. In a cross-sectional study of 84 HIV+ individuals of whom 43 were followed longitudinally, we found that HIV-1 RNAs are present in extracellular vesicles (EVs) derived from cerebrospinal fluid and serum of all individuals. We used seven digital droplet polymerase chain reaction assays to evaluate the transcriptional status of the latent reservoir. EV-associated viral RNA was more abundant in the CSF and correlated with neurocognitive dysfunction in both, the cross-sectional and longitudinal studies. Sequencing studies suggested compartmentalization of defective viral transcripts in the serum and CSF. These findings suggest previous studies have underestimated the viral burden and there is a significant relationship between latent viral transcription and CNS complications of long-term disease despite the adequate use of antiretrovirals.

Creating a Palliative Care Clinic for Patients with Cancer Pain and Substance Use Disorder.

BACKGROUND: Opioids are a first-line treatment for severe cancer pain. However, clinicians may be reluctant to prescribe opioids for patients with concurrent substance use disorders (SUD) or clinical concerns about non-prescribed substance use. MEASURES: Patient volume, 60-day retention rate, and use of sublingual buprenorphine to treat opioid use disorder. INTERVENTION: We created the Palliative Harm Reduction and Resiliency Clinic, a palliative care clinic founded on harm reduction principles and including formal collaboration with addiction psychiatry. OUTCOMES: During the first 18 months, patient volume increased steadily; 70% of patients had at least one subsequent visit within 60 days of the initial appointment; and buprenorphine was prescribed for 55% of patients with opioid use disorder. CONCLUSIONS/LESSONS LEARNED: The formal collaboration with addiction psychiatry and the integration of harm reduction principles and practices into ambulatory palliative care improved our ability to provide treatment to a previously underserved patient population with high symptom burden.

Similarities and Differences Between Pragmatic Trials and Hybrid Effectiveness-Implementation Trials.

Pragmatism in clinical trials is focused on increasing the generalizability of research findings for routine clinical care settings. Hybridism in clinical trials (i.e., assessing both clinical effectiveness and implementation success) is focused on speeding up the process by which evidence-based practices are developed and adopted into routine clinical care. Even though pragmatic trial methodologies and implementation science evolved from very different disciplines, Pragmatic Trials and Hybrid Effectiveness-Implementation Trials share many similar design features. In fact, these types of trials can easily be conflated, creating the potential for investigators to mislabel their trial type or mistakenly use the wrong trial type to answer their research question. Blurred boundaries between trial types can hamper the evaluation of grant applications, the scientific interpretation of findings, and policy-making. Acknowledging that most trials are not pure Pragmatic Trials nor pure Hybrid Effectiveness-Implementation Trials, there are key differences in these trial types and they answer very different research questions. The purpose of this paper is to clarify the similarities and differences of these trial types for funders, researchers, and policy-makers. In addition, recommendations are offered to help investigators choose, label, and operationalize the most appropriate trial type to answer their research question. These recommendations complement existing reporting guidelines for clinical effectiveness trials (TIDieR) and implementation trials (StaRI).

Racial and ethnic disparities in genomic testing among lung cancer patients: a systematic review.

BACKGROUND: Racial and ethnic disparities in genomic testing could exacerbate disparities in access to precision cancer therapies and survival-particularly in the context of lung cancer where genomic testing has been recommended for the past decade. However, prior studies assessing disparities in genomic testing have yielded mixed results. METHODS: We conducted a systemic review to examine racial and ethnic disparities in the use of genomic testing among lung cancer patients in the United States. Two comprehensive searches in PubMed, Embase, and Scopus were conducted (September 2022, May 2023). Original studies that assessed rates of genomic testing by race or ethnicity were included. Findings were narratively synthesized by outcome. RESULTS: The search yielded 2739 unique records, resulting in 18 included studies. All but 1 study were limited to patients diagnosed with non-small cell lung cancer. Diagnosis years ranged from 2007 to 2022. Of the 18 studies, 11 found statistically significant differences in the likelihood of genomic testing by race or ethnicity; in 7 of these studies, testing was lower among Black patients compared with White or Asian patients. However, many studies lacked adjustment for key covariates and included patients with unclear eligibility for testing. CONCLUSIONS: A majority of studies, though not all, observed racial and ethnic disparities in the use of genomic testing among patients with lung cancer. Heterogeneity of study results throughout a period of changing clinical guidelines suggests that minoritized populations-Black patients in particular-have faced additional barriers to genomic testing, even if not universally observed at all institutions.

Factors Affecting Post-trial Sustainment or De-implementation of Study Interventions: A Narrative Review.

In contrast to traditional randomized controlled trials, embedded pragmatic clinical trials (ePCTs) are conducted within healthcare settings with real-world patient populations. ePCTs are intentionally designed to align with health system priorities leveraging existing healthcare system infrastructure and resources to ease intervention implementation and increase the likelihood that effective interventions translate into routine practice following the trial. The NIH Pragmatic Trials Collaboratory, funded by the National Institutes of Health (NIH), supports the conduct of large-scale ePCT Demonstration Projects that address major public health issues within healthcare systems. The Collaboratory has a unique opportunity to draw on the Demonstration Project experiences to generate lessons learned related to ePCTs and the dissemination and implementation of interventions tested in ePCTs. In this article, we use case studies from six completed Demonstration Projects to summarize the Collaboratory's experience with post-trial interpretation of results, and implications for sustainment (or de-implementation) of tested interventions. We highlight three key lessons learned. First, ineffective interventions (i.e., ePCT is null for the primary outcome) may be sustained if they have other measured benefits (e.g., secondary outcome or subgroup) or even perceived benefits (e.g., staff like the intervention). Second, effective interventions-even those solicited by the health system and/or designed with significant health system partner buy-in-may not be sustained if they require significant resources. Third, alignment with policy incentives is essential for achieving sustainment and scale-up of effective interventions. Our experiences point to several recommendations to aid in considering post-trial sustainment or de-implementation of interventions tested in ePCTs: (1) include secondary outcome measures that are salient to health system partners; (2) collect all appropriate data to allow for post hoc analysis of subgroups; (3) collect experience data from clinicians and staff; (4) engage policy-makers before starting the trial.

Depth- and curvature-based quantitative susceptibility mapping analyses of cortical iron in Alzheimer's disease.

In addition to amyloid beta plaques and neurofibrillary tangles, Alzheimer's disease (AD) has been associated with elevated iron in deep gray matter nuclei using quantitative susceptibility mapping (QSM). However, only a few studies have examined cortical iron, using more macroscopic approaches that cannot assess layer-specific differences. Here, we conducted column-based QSM analyses to assess whether AD-related increases in cortical iron vary in relation to layer-specific differences in the type and density of neurons. We obtained global and regional measures of positive (iron) and negative (myelin, protein aggregation) susceptibility from 22 adults with AD and 22 demographically matched healthy controls. Depth-wise analyses indicated that global susceptibility increased from the pial surface to the gray/white matter boundary, with a larger slope for positive susceptibility in the left hemisphere for adults with AD than controls. Curvature-based analyses indicated larger global susceptibility for adults with AD versus controls; the right hemisphere versus left; and gyri versus sulci. Region-of-interest analyses identified similar depth- and curvature-specific group differences, especially for temporo-parietal regions. Finding that iron accumulates in a topographically heterogenous manner across the cortical mantle may help explain the profound cognitive deterioration that differentiates AD from the slowing of general motor processes in healthy aging.

Substance Use Disorders Among US Adult Cancer Survivors.

Importance: Some individuals are predisposed to cancer based on their substance use history, and others may use substances to manage cancer-related symptoms. Yet the intersection of substance use disorder (SUD) and cancer is understudied. Because SUD may affect and be affected by cancer care, it is important to identify cancer populations with a high prevalence of SUD, with the goal of guiding attention and resources toward groups and settings where interventions may be needed. Objective: To describe the cancer type-specific prevalence of SUD among adult cancer survivors. Design, Setting, and Participants: This cross-sectional study used data from the annually administered National Survey on Drug Use and Health (NSDUH) for 2015 through 2020 to identify adults with a history of solid tumor cancer. Substance use disorder was defined as meeting at least 1 of 4 Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition) criteria for abuse or at least 3 of 6 criteria for dependence. Main Outcomes and Measures: Per NSDUH guidelines, we made adjustments to analysis weights by dividing weights provided in the pooled NSDUH data sets by the number of years of combined data (eg, 6 for 2015-2020). The weighted prevalence and corresponding SEs (both expressed as percentages) of active SUD (ie, within the past 12 months) were calculated for respondents with any lifetime history of cancer and, in secondary analyses, respondents diagnosed with cancer within 12 months prior to taking the survey. Data were analyzed from July 2022 to June 2023. Results: This study included data from 6101 adult cancer survivors (56.91% were aged 65 years or older and 61.63% were female). Among lifetime cancer survivors, the prevalence of active SUD was 3.83% (SE, 0.32%). Substance use disorder was most prevalent in survivors of head and neck cancer (including mouth, tongue, lip, throat, and pharyngeal cancers; 9.36% [SE, 2.47%]), esophageal and gastric cancer (9.42% [SE, 5.51%]), cervical cancer (6.24% [SE, 1.41%]), and melanoma (6.20% [SE, 1.34%]). Alcohol use disorder was the most common SUD (2.78% [SE, 0.26%]) overall and in survivors of head and neck cancer, cervical cancer, and melanoma. In survivors of esophageal and gastric cancers, cannabis use disorder was the most prevalent SUD (9.42% [SE, 5.51%]). Among respondents diagnosed with cancer in the past 12 months, the overall prevalence of active SUD was similar to that in the lifetime cancer survivor cohort (3.81% [SE, 0.74%]). However, active SUD prevalence was higher in head and neck (18.73% [SE, 10.56%]) and cervical cancer survivors (15.70% [SE, 5.35%]). The distribution of specific SUDs was different compared with that in the lifetime cancer survivor cohort. For example, in recently diagnosed head and neck cancer survivors, sedative use disorder was the most common SUD (9.81% [SE, 9.17%]). Conclusions and Relevance: Findings of this study suggest that SUD prevalence is higher among survivors of certain types of cancer; this information could be used to identify cancer survivors who may benefit from integrated cancer and SUD care. Future efforts to understand and address the needs of adult cancer survivors with comorbid SUD should prioritize cancer populations in which SUD prevalence is high.

Embedding implementation science in the research pipeline.

Clinical and health services researchers seek to discover effective programs, practices, and interventions to improve people's health. The current paradigm for evidence generation is incremental and misaligned to translate evidence-based discoveries into real-world settings. This persistent challenge are "valleys of death" that represent missed opportunities and preventable missteps to actually use scientific advancements in real-world clinical settings where they can improve health and well-being (De Geest S, Zúñiga F, Brunkert T et al. Powering Swiss health care for the future: implementation science to bridge "the valley of death". 2020;150:w20323). Only one in seven of evidence-based interventions is ever implemented. It is after an average of 17 years. We propose embedding the principles of implementation science throughout the research pipeline, from discovery to adoption, to efficiently translate discoveries into real-world contexts (Balas EA, Boren SA. Managing clinical knowledge for health care improvement. 2000;9:65-70). We outline implications for capacity building, including composition of the research team, study design, and competencies that could bolster the value proposition of implementation science. We describe a research paradigm that recognizes scientists' responsibility to ensure their discoveries be translated into real-world settings.

Most innovative research is not used in clinical care settings. When it is, it takes a very long time to get into the real world. This means that patients may not get the best care possible to improve their health. The research community has tools that can help design innovative research in ways that it could work in clinical care settings and tools to help that happen faster, so that clinical care teams and patients can use innovative research. This is called implementation science. We outline why it is important to use implementation science ideas and teams earlier and how we can support infrastructure to do so.

Characteristics, healthcare utilization, and outcomes of patients with HER2-low breast cancer.

PURPOSE: Treatment for HER2-low [defined as ImmunoHistoChemistry (IHC) 1 + or 2 + and negative/normal in Situ Hybridization (ISH)] breast cancer patients is rapidly evolving, yet we lack critical information about the HER2-low population. METHODS: We conducted a retrospective cohort study of women aged 18 years or older diagnosed with breast cancer between 2010 and 2016 in North Carolina. Analyses were conducted for the overall cohort and a stage IV sub-cohort. We examined demographic and clinical characteristics, and characterized prevalence of HER2-low disease and healthcare utilization. We estimated adjusted rate ratios for the association between HER2 classifications and utilization outcomes, and hazard ratios for 3-year all cause mortality (stage IV only). RESULTS: The overall and stage IV cohorts included 12,965 and 635 patients, respectively. HER2-low patients represented more than half of both cohorts (59% overall, 53% stage IV). HER2-low patients were more likely than IHC 0 patients to have hormone receptor (HR)-positive disease. In the stage IV cohort, HER2-low patients were more likely to be Black (26% vs. 16% IHC 0, p = 0.0159). In both cohorts, rates of hospitalizations were slightly higher among HER2-low patients. There were no survival differences between HER2-low and IHC 0 among stage IV patients. CONCLUSION: New treatment options for HER2-low breast cancer may have potential for significant impact at the population level particularly for patients with stage IV disease. In light of racial differences between HER2-low and IHC 0 patients observed in our cohort, research- and practice-based efforts to ensure equitable adoption of new treatment guidelines for patients with HER2-low metastatic breast cancer will be essential.

Overlapping Science in Radiation and Sulfur Mustard Exposures of Skin and Lung: Consideration of Models, Mechanisms, Organ Systems, and Medical Countermeasures: Overlapping science in radiation and sulfur mustard injuries to lung and skin.

PURPOSE: To summarize presentations and discussions from the 2022 trans-agency workshop titled "Overlapping science in radiation and sulfur mustard (SM) exposures of skin and lung: Consideration of models, mechanisms, organ systems, and medical countermeasures." METHODS: Summary on topics includes: (1) an overview of the radiation and chemical countermeasure development programs and missions; (2) regulatory and industry perspectives for drugs and devices; 3) pathophysiology of skin and lung following radiation or SM exposure; 4) mechanisms of action/targets, biomarkers of injury; and 5) animal models that simulate anticipated clinical responses. RESULTS: There are striking similarities between injuries caused by radiation and SM exposures. Primary outcomes from both types of exposure include acute injuries, while late complications comprise chronic inflammation, oxidative stress, and vascular dysfunction, which can culminate in fibrosis in both skin and lung organ systems. This workshop brought together academic and industrial researchers, medical practitioners, US Government program officials, and regulators to discuss lung-, and skin- specific animal models and biomarkers, novel pathways of injury and recovery, and paths to licensure for products to address radiation or SM injuries. CONCLUSIONS: Regular communications between the radiological and chemical injury research communities can enhance the state-of-the-science, provide a unique perspective on novel therapeutic strategies, and improve overall US Government emergency preparedness.

Meaning-centered pain coping skills training for patients with metastatic cancer: Protocol for a randomized controlled efficacy trial.

BACKGROUND: Many patients with advanced cancer describe pain as a debilitating symptom that greatly interferes with daily activities and enjoyment of life. Psychosocial interventions can improve cancer-related pain but rarely address spiritual concerns (e.g., loss of meaning, peace), which can influence the pain experience for those facing life-threatening illness. To address these needs, we systematically developed and pilot tested a novel psychosocial intervention called Meaning-Centered Pain Coping Skills Training (MCPC). In this randomized controlled trial, we aim to determine MCPC's efficacy for reducing pain interference (primary outcome) and improving secondary outcomes. We will also estimate MCPC's cost-effectiveness. METHOD/DESIGN: Patients (target N = 210) with advanced solid tumor malignancies (Stage IV) and clinically-elevated pain interference will be enrolled and block randomized with equal allocation to MCPC + enhanced usual care or enhanced usual care alone. MCPC's four, videoconferenced, 45-60 min weekly sessions will be individually delivered by trained study therapists. Primary (pain interference) and secondary (pain severity, anxiety and depressive symptoms, pain self-efficacy, social support, spiritual well-being) patient-reported outcomes will be assessed at baseline, and 8-weeks (primary endpoint) and 12-weeks after baseline. CONCLUSION: Our MCPC intervention is the first to systematically address the biopsychosocial-spiritual aspects of pain in patients with advanced cancer. If MCPC demonstrates efficacy, next steps will involve hybrid efficacy-effectiveness and implementation work to broaden access to this brief, manualized, remotely-delivered intervention, with the goal of reducing suffering in patients with life-threatening illness.

Hippocampal and amygdala volumes vary with residential proximity to toxicants at Birmingham, Alabama's 35th Avenue Superfund site.

Exposure to environmental toxicants have serious implications for the general health and well-being of children, particularly during pivotal neurodevelopmental stages. The Environmental Protection Agency's (EPA) Superfund program has identified several areas (Superfund sites) across the United States with high levels of environmental toxicants, which affect the health of many residents in nearby communities. Exposure to these environmental toxicants has been linked to changes in the structure and function of the brain. However, limited research has investigated the relationship between the proximity of childhood homes to a Superfund site and the development of subcortical structures like the hippocampus and amygdala. The present study investigated the hippocampal and amygdala volumes of young adults in relation to the proximity of their childhood homes to Birmingham, Alabama's 35th Avenue Superfund site. Forty participants who either lived within or adjacent to the Superfund site (Proximal group; n = 20) or who lived elsewhere in the greater Birmingham metropolitan area (Distal group; n = 20) were included in this study. Both groups were matched on age, sex, race, and years of education. Magnetic resonance imaging (MRI) was used to compare the gray matter volume of the hippocampus and amygdala between groups. Differences in bilateral hippocampal and left amygdala volumes were observed. Specifically, hippocampal and amygdala volumes were greater in the Proximal than Distal group. These findings suggest that the proximity of children's homes to environmental toxicants may impact the development of the hippocampus and amygdala. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

Numerical simulations of an integrated radio-frequency/wireless coil design for simultaneous acquisition and wireless transfer of magnetic resonance imaging data.

Objective.A novel magnetic resonance imaging (MRI) radio-frequency (RF) coil design, termed an integrated RF/wireless (iRFW) coil design, can simultaneously perform MRI signal reception and far-field wireless data transfer with the same coil conductors between the coil in the scanner bore and an access point (AP) on the scanner room wall. The objective of this work is to optimize the design inside the scanner bore to provide a link budget between the coil and the AP for the wireless transmission of MRI data.Approach.Electromagnetic simulations were performed at the Larmor frequency of a 3T scanner and in a WiFi wireless communication band to optimize the radius and position of an iRFW coil located near the head of a human model inside the scanner bore, which were validated by performing both imaging and wireless experiments.Main Results.The simulated iRFW coil with a 40 mm radius positioned near the model forehead provided: a signal-to-noise ratio (SNR) comparable to that of a traditional RF coil with the same radius and position, a power absorbed by the human model within regulatory limits, and a gain pattern in the scanner bore resulting in a link budget of 51.1 dB between the coil and an AP located behind the scanner 3 m from the isocenter, which would be sufficient to wirelessly transfer MRI data acquired with a 16-channel coil array. The SNR, gain pattern, and link budget for initial simulations were validated by experimental measurements in an MRI scanner and anechoic chamber to provide confidence in this methodology. These results show that the iRFW coil design must be optimized within the scanner bore for the wireless transfer of MRI data.Significance.The MRI RF coil array coaxial cable assembly connected to the scanner increases patient setup time, can present a serious burn risk to patients and is an obstacle to the development of the next generation of lightweight, flexible or wearable coil arrays that provide an improved coil sensitivity for imaging. Significantly, the RF coaxial cables and corresponding receive chain electronics can be removed from within the scanner by integrating the iRFW coil design into an array for the wireless transmission of MRI data outside of the bore.

Evaluation of a Student-Led Community-Based Veterinary Clinic for Disabled Low-Income Clients: A Case Study of the University of Florida PAWS Program.

People with disabilities experiencing low socioeconomic position are priority populations when considering access to veterinary care. In this population, intersectional inequities lead to adverse health outcomes for both those individuals and the companion animals they care for. Community-based veterinary clinics provide an opportunity to target these inequities from a culturally sensitive lens, intending to improve human and animal outcomes. We conducted a process evaluation of a student-led community-based clinic for this population to better understand client satisfaction, assess learning outcomes among veterinary students, and improve program delivery and services. During academic year 2020-2021, the monthly clinics had 162 appointments in total with a median 15 DVM candidates volunteering at each clinic. Clients and volunteers responded to survey questionnaires designed to elicit information about their experiences with the clinic, including open-ended questions for further elucidation of measurable indicators of client-, patient-, and student-level impact. Clients attributed enrollment in the clinic with improved quality-of-life and reduction of financial burden; the program saved clients approximately $2,050 per pet during the evaluation year. Furthermore, the clinic widely facilitated completion of the college's core Primary Care and Dentistry learning outcomes. Beyond curriculum-standard learning objectives, students also reported positive attitude changes and increased readiness to provide care to people with disabilities and people experiencing low socioeconomic position. The results of this evaluation have significant implications for both veterinary and public health pedagogy. Especially, they highlight the significance of community health practice in veterinary trainee education.

Meaning-centered pain coping skills training for patients with metastatic cancer: Results of a randomized controlled pilot trial.

OBJECTIVE: For patients with advanced cancer, pain is a common and debilitating symptom that can negatively impact physical, emotional, and spiritual well-being. This trial examined the feasibility and initial effects of Meaning-Centered Pain Coping Skills Training (MCPC), a cognitive-behavioral pain management intervention with an emphasis on enhancing meaning (i.e., a personal sense of purpose, worth, and significance) and peace. METHODS: We enrolled 60 adults with stage IV solid tumor cancers and moderate-severe pain between February 2021 and February 2022. Participants were randomized 1:1 to MCPC + usual care or usual care alone. Meaning-Centered Pain Coping Skills Training consisted of four weekly 60-min individual sessions via videoconference or telephone, delivered by a trained therapist using a manualized protocol. Participants completed validated measures of pain severity, pain interference, pain self-efficacy, spiritual well-being (i.e., meaning, peace, and faith), and psychological distress at baseline and 5-week and 10-week follow-ups. RESULTS: All feasibility metrics exceeded prespecified benchmarks. Fifty-eight percent of screened patients were eligible, and 69% of eligible patients consented. Of those assigned to MCPC, 93% completed all sessions and 100% of those who completed follow-ups reported using coping skills weekly. Retention was strong at 5-week (85%) and 10-week (78%) follow-ups. Meaning-Centered Pain Coping Skills Training participants reported better scores than control participants across outcome measures, including moderate-to-large sized differences at 10-week follow-up in pain severity (Cohen's d = -0.75 [95% confidence interval: -1.36, -0.14]), pain interference (d = -0.82 [-1.45, -0.20]), and pain self-efficacy (d = 0.74 [0.13, 1.35]). CONCLUSIONS: MCPC is a highly feasible, engaging, and promising approach for improving pain management in advanced cancer. Future efficacy testing is warranted. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04431830, registered 16 June 2020.

The Use of Templates for Documenting Advance Care Planning Conversations: A Descriptive Analysis.

CONTEXT: While professional societies and expert panels have recommended quality indicators related to advance care planning (ACP) documentation, including using structured documentation templates, it is unclear how clinicians document these conversations. OBJECTIVE: To explore how clinicians document ACP, specifically, which components of these conversations are documented. METHODS: A codebook was developed based on existing frameworks for ACP conversations and documentation. ACP documentation from a hospital medicine quality improvement project conducted from November 2019 to April 2021 were included and assessed. Documentation was examined for the presence or absence of each component within the coding schema. Clinician documented ACP using three different note types: template (only template prompts were used), template plus (authors added additional text to the template), and free text only. ACP note components were analyzed by note type and author department. RESULTS: A total of 182 ACP notes were identified and reviewed. The most common note type was template plus (58%), followed by free text (28%) and template (14%). The most frequent components across all note types were: important relationships to patient (92%), and discussion of life-sustaining treatment preferences (87%). There was considerable heterogeneity in the components across note types. The presence of components focused on treatment decisions and legal paperwork differed significantly between note types (P < 0.05). Components on preference for medical information, emotional state, or spiritual support were rarely included across all note types. CONCLUSION: This study provides a preliminary exploration of ACP documentation and found that templates may influence what information is documented after an ACP conversation.

Factors Associated With Receipt of Molecular Testing and its Impact on Time to Initial Systemic Therapy in Metastatic Non-Small Cell Lung Cancer.

BACKGROUND: Despite recommendations for molecular testing irrespective of patient characteristics, differences exist in receipt of molecular testing for oncogenic drivers amongst metastatic non-small cell lung cancer (mNSCLC) patients. Exploration into these differences and their effects on treatment is needed to identify opportunities for improvement. PATIENTS AND METHODS: We conducted a retrospective cohort study of adult patients diagnosed with mNSCLC between 2011 and 2018 using PCORnet's Rapid Cycle Research Project dataset (n = 3600). Log-binomial, Cox proportional hazards (PH), and time-varying Cox regression models were used to ascertain whether molecular testing was received, and time from diagnosis to molecular testing and/or initial systemic treatment in the context of patient age, sex, race/ethnicity, and multiple comorbidities status. RESULTS: The majority of patients in this cohort were ≤ 65 years of age (median [25th, 75th]: 64 [57, 71]), male (54.3%), non-Hispanic white individuals (81.6%), with > 2 comorbidities in addition to mNSCLC (54.1%). About half the cohort received molecular testing (49.9%). Patients who received molecular testing had a 59% higher probability of initial systemic treatment than patients who were yet to receive testing. Multiple comorbidity status was positively associated with receipt of molecular testing (RR, 1.27; 95% CI 1.08, 1.49). CONCLUSION: Receipt of molecular testing in academic centers was associated with earlier initiation of systemic treatment. This finding underscores the need to increase molecular testing rates amongst mNSCLC patients during a clinically relevant period. Further studies to validate these findings in community centers are warranted.