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Background: Many interventions improve care and outcomes for people with Alzheimer's Disease and related dementias (ADRD), yet are never disseminated. Pragmatic trials facilitate the adoption and dissemination of best practices, but gaps in pragmatic outcome measurement are a critical obstacle. Our objectives are (1) to describe the development and structure of the IMbedded Pragmatic ADRD Clinical Trials Collaboratory (IMPACT) iLibrary of potential outcome measures for ADRD pragmatic trials, and (2) to assess their pragmatic characteristics. Methods: We identified potential outcome measures from several sources: a database of administrative and clinical outcome measures from ADRD clinical trials registered in ClinicalTrials.gov, published reviews, and IMPACT pilot pragmatic trial outcome measures. The iLibrary reports (a) number of items, (b) completion time, (c) readability for diverse populations, (d) cost or copyright barriers to use, (e) method of administration, (f) assessor training burden, and (g) feasibility of data capture and interpretation in routine care; a summary of pragmatic characteristics of each outcome measure (high, moderate, low); items or descriptions of items; and links to primary citations regarding development or psychometric properties. Results: We included 140 outcome measures in the iLibrary: 66 administrative (100% were pragmatic) and 74 clinical (52% were pragmatic). The most commonly addressed outcome domains from administrative assessments included physical function, quality of care or communication concerns, and psychological symptoms or distress behaviors. The most commonly addressed outcome domains from clinical assessments were psychological symptoms or distress behaviors, physical function, cognitive function, and health‐related quality of life. Conclusions: Pragmatic outcome measures are brief, meaningful to diverse populations, easily scored and interpreted by clinicians, and available in electronic format for analysis. The iLibrary can facilitate the selection of measures for a wide range of outcomes relevant to people with ADRD and their care partners. [ABSTRACT FROM AUTHOR]

Background: The National Institute on Aging (NIA) Imbedded Pragmatic Alzheimer's Disease and Alzheimer's Related Dementia Clinical Trials (IMPACT) Collaboratory convened a Lived Experience Panel (LEP) to inform the development of research priorities and provide input on conducting embedded pragmatic clinical trials (ePCTs) of dementia care interventions. Given the importance of people with lived experience to dementia research, and the unique considerations of engaging people with dementia, we report on our process for the recruitment, selection, and initial convening of the IMPACT LEP. Methods: The IMPACT Engaging Partners Team, in partnership with the Alzheimer's Association, sought nominations of individuals with mild cognitive impairment or early‐stage dementia, care partners of other people living with dementia (PLWD), and proxy representatives for individuals with mid‐to‐late stage dementia. The 11‐member LEP was composed of individuals with diverse personal experiences in part due to their age, race, ethnicity, gender, sexual orientation, geography, disability, or type of dementia. In its first year, the LEP met with IMPACT's Patient and Caregiver Relevant Outcomes Core and Ethics and Regulation Core. Results: LEP members provided valuable insights and nuanced discussion of issues relevant to ePCTs in dementia care from a broad range of personal experience. Panelists identified key research priorities and provided insight on outcomes often studied by researchers. The LEP also informed investigators' approaches to waivers and modifications of written informed consent and evaluation of minimal risk. Summary reports of the LEP meetings with each Core are available on the IMPACT website. At the end of the first year, changes were made to the composition of the LEP, and opportunities were identified for expanding panelist engagement with IMPACT investigators, as were priorities and scope for future input. Conclusions: The IMPACT LEP provides a model for engaging PLWD and care partners in the research process as collaborators. [ABSTRACT FROM AUTHOR]

1. Understand the demographic, clinical characteristics, and pain severity of the participants enrolled into a prospective cohort study of opioid benefits and harms. 2. Apply the evidence, recognize potential important harms and benefits to opioids for pain management in patients with advanced cancer. The evidence base available to guide opioid-related decision-making in individuals with advanced cancer is limited. Here, we present the baseline characteristics, particularly pain, substance use, and opioid prescribing, of a prospective cohort developed to investigate the benefits and harms of opioid prescribing in individuals with advanced cancer. There is limited evidence available to guide opioid-related decision-making in individuals with advanced cancer.(1,2) For example, the risks with benzodiazepines co-prescribing, substance use, or overdose. To fill the urgently needed clinical and research gap on opioid benefits and harms in individuals with advanced cancer, we describe baseline cohort characteristics as of 10/13/2023. This study is a multisite longitudinal cohort study using patient reported outcomes (PROs) (10/2022-present). Participants have a recent (within 12 weeks of enrollment) advanced cancer diagnosis and maximal opioid exposure of less than 90 consecutive days in the prior year. PRO measures include the Pain, Enjoyment, and General Activity (PEG scale).(3) Additionally, participants complete surveys on demographics, mortality risk and substance use history. A total of 154 participants completed baseline assessments. Cohort demographics include mean age 66 years; 42% were female; 79% identified as White, 12% Black, and 11% Hispanic. The most common cancers were prostate (19%), lung (16%), and pancreatic (12%). With a look back period of 3 months, 46% reported potentially problematic use of alcohol, 20% cannabis, and 1% prescription opioids. The mean PEG score on a 0 to 10 scale was 2.3 (SD=2.6). Thirty-six percent were prescribed opioids in the three months prior to enrollment. Fifty-two percent of participants had a low risk of two-year mortality. We have recruited 154 participants with advanced cancer and anticipate recruiting 630 participants by November 2024. The cohort reported mild pain severity, one-third were prescribed opioids at baseline and nearly half reported risky alcohol use. These rates mirror declining pain severity and opioid prescribing but indicate slightly higher substance use rates than recent literature. (4,5) Subsequent aims will investigate opioid benefits/harms and conduct qualitative interviews to understand opioid-related decision-making in patients, clinicians, and caregivers. Successful study completion will inform future interventions guiding opioid-related decision-making in individuals with advanced cancer. [ABSTRACT FROM AUTHOR]

Background/aims: The Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE ® ) was developed to capture symptomatic adverse events from the patient perspective. We aim to describe statistical properties of PRO-CTCAE items and summary scores and to provide evidence for recommendations regarding PRO-CTCAE administration and reporting., Methods: Using data from the PRO-CTCAE validation study (NCT02158637), prevalence, means, and standard deviations of PRO-CTCAE items, composite scores, and mean and maximum scores across attributes (frequency, severity, and/or interference) of symptomatic adverse events were calculated. For each adverse event, correlations and agreement between attributes, correlations between attributes and composite scores, and correlations between composite, mean, and maximum scores were estimated., Results: PRO-CTCAE items were completed by 899 patients with various cancer types. Most patients reported experiencing one or more adverse events, with the most prevalent being fatigue (87.7%), sad/unhappy feelings (66.0%), anxiety (63.6%), pain (63.2%), insomnia (61.8%), and dry mouth (60.0%). Attributes were moderately to strongly correlated within an adverse event ( r  = 0.53 to 0.77, all p  < 0.001) but not fully concordant (κ weighted  = 0.26 to 0.60, all p  < 0.001), with interference demonstrating lowest mean scores and prevalence among attributes of the same adverse event. Attributes were moderately to strongly correlated with composite scores ( r  = 0.67 to 0.97, all p  < 0.001). Composite scores were moderately to strongly correlated with mean and maximum scores for the same adverse event ( r  = 0.69 to 0.94, all p  < 0.001). Correlations between composite scores of different adverse events varied widely ( r  = 0.04 to 0.68) but were moderate to strong for conceptually related adverse events., Conclusions: Results provide evidence for PRO-CTCAE administration and reporting recommendations that the full complement of attributes be administered for each adverse event, and that attributes as well as summary scores be reported., Competing Interests: Declaration of conflicting interestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Objectives: To estimate the proportion and correlates of self-reported financial difficulty among patients with multiple myeloma (MM) or chronic lymphocytic leukemia (CLL)., Setting: 23 U.S. community and minority oncology practice sites affiliated with the National Cancer Institute Community Oncology Research Program (NCORP)., Participants: 521 patients (≥18 years) with MM or CLL were consented and 416 responded to a survey (completion rate=79.8%). Respondents had a MM diagnosis (74.0%), an associate degree or higher (53.4%), were White (89.2%), insured (100%) and treated with clinician-administered drugs (68.0%)., Interventions: Observational, prospective, protocol-based survey administered in 2019-2020., Primary and Secondary Outcome Measures: Financial difficulty was assessed using a single-item standard measure, the EORTC QLQC30: "Has your physical condition or medical treatment caused you financial difficulties in the past year?" and using an 'any-or-none' composite measure of 22 items assessing financial difficulty, worries and the use of cost-coping strategies. Multivariable logistic regression models assessed the association between financial difficulty, diagnosis, and socioeconomic and treatment characteristics., Results: 16.8% reported experiencing financial difficulty using the single-item measure and 60.3% using the composite measure. Most frequently endorsed items in the composite measure were financial worry about having to pay large medical bills related to cancer and difficulty paying medical bills. Financial difficulty using the single-item measure was associated with having MM versus CLL (adjusted odds ratio [aOR], 0.34; 95% CI, 0.13-0.84; P =.02), having insurance other than Medicare (aOR, 2.53; 95% CI, 1.37-4.66; P =.003), being non-White (aOR, 2.21; 95% CI, 1.04-4.72; P =.04), and having a high school education or below (aOR, 0.36; 95% CI, 0.21-0.64; P =.001). Financial difficulty using the composite measure was associated with having a high school education or below (aOR, 0.62; 95% CI, 0.41-0.94; P =.03)., Conclusions: U.S. patients with blood cancer report financial difficulty, especially those with low socio-economic status. Evidence-based and targeted interventions are needed., Competing Interests: Competing Interest Statement: Conti reports research support from the National Science Foundation, the National Cancer Institute, the National Institute on Drug Abuse, the Veterans Administration, the Leukemia and Lymphoma Society, the Sloan Foundation and Arnold Ventures and consulting fees from Greylock McKinnon Associates unrelated to this manuscript. All other authors declare no conflicts of interest to disclose.

Context: For many, the perception of "hospice" is synonymous with "death." Even clinicians struggle to have conversations that distinguish between hospice and palliative care for fear that discussing hospice may diminish hope. To date, there are no existing measurement tools to evaluate patient and family perceptions of hospice care., Objective: This research aimed to develop a Hospice Perceptions Instrument (HPI) to capture these perceptions among diverse patients and families., Methods: Building on previous studies and literature, 79 potential items were drafted for the instrument. Our interprofessional team independently and collectively evaluated these, resulting in 36 items rated on a 5-point Likert scale. Overarching domains include (1) hospice philosophy and definitions; (2) hospice services; (3) values; and (4) counter-perceptions. Sixteen national subject matter experts from various professions and roles were invited to participate in the content-validity index and five hospice caregivers were invited to participate in face validity., Results: Fourteen experts responded, with ten meeting inclusion criteria: one physician, four nurses, three social workers, and two chaplains. Six of the ten identified as Black. Three items were removed (I-CVI ranged from 0.5-06), and nine items were revised (I-CVI ranged from 0.6-07). The overall Content Validity Index (CVI) was 0.83, indicating excellent content validity. After revisions, five hospice caregivers assessed face validity and no changes were made based on feedback., Conclusion: Results reveal a disconnect between professional expertise and patient/family voices related to hospice perceptions. Development of this instrument invites a better understanding of perceptions leading to new opportunities for patient/family engagement., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.