Patient-Centered Outcomes Research Research Articles

0774 Positive Airway Pressure Utilization, Major Adverse Cardiovascular Events Incidence Risk and Mortality in Medicare Beneficiaries with Obstructive Sleep Apnea

Abstract Introduction Positive airway pressure (PAP) is the first line treatment for moderate-severe or symptomatic obstructive sleep apnea (OSA). Randomized controlled trials have established that PAP therapy has beneficial impact on cardiovascular and metabolic functions. However, evidence on the benefits of PAP for preventing major adverse cardiovascular events (MACE) is limited. We aimed to determine the association between PAP utilization and incidence of MACE and all-cause mortality in a large sample of Medicare beneficiaries. Methods Medicare beneficiaries (>65 years) with at least 5 years of consecutive enrollment to part A and B and ≥2 distinct OSA claims were collected from multi-state (Kansas, Missouri, Iowa, Wisconsin, Nebraska, Minnesota, Texas, Utah, North Dakota, South Dakota and Indiana), multi-year (2011-2017) Medicare fee-for-service claims data. We further required at least 1-year enrollment before the first OSA claim. Evidence of PAP utilization and index date was defined based on the first Healthcare Common Procedure Coding System PAP initiation codes (E0601, E0470, E0471) after first OSA diagnosis. MACE was defined as the first occurrence of myocardial infarction, coronary revascularization, stroke, or heart failure (identified by diagnostic and procedure code claims) after PAP initiation. Analyses were adjusted by age at initial OSA diagnosis, sex, race and presence of hypertension, type 2 diabetes, obesity, and evidence of MACE prior to the index date. Results Our sample included 212,445 eligible Medicare beneficiaries with evidence of OSA diagnosis (mean [SD] age 75 [5.7] years; 45.2% women; median [Q1, Q3] follow-up 4 [2.0, 4.9] years at censoring). Five-year MACE cumulative incidence rate was 59.3% and the mortality rate was 17.8%. In adjusted analyses, OSA patients with evidence of PAP utilization (50.8%) had significantly lower MACE incidence risk (HR=0.812; 95%CI=0.803-0.822; p<0.0001) when compared to those without evidence of using PAP. OSA patients with evidence of PAP utilization also had significantly lower mortality risk (HR=0.575; 95%CI=0.560-0.591; p<0.0001). Pre-existing hypertension, type II diabetes and obesity were also significantly associated with increased mortality and MACE risk. Conclusion PAP utilization based on device initiation derived from claims data is associated with lower MACE incidence and mortality in older adults that are Medicare beneficiaries. Support (If Any) American Heart Association (20CDA35310360), Patient-Centered Outcomes Research Institute (RI-CRN-2020-003-IC); NIH CTSA NCATS Frontiers: University of Kansas Clinical and Translational Science Institute (UL1TR002366); Tier 2 grant, University of Missouri.

Harm-to-Benefit of Three Decades of Prostate Cancer Screening in Black Men

BackgroundProstate-specific antigen screening has profoundly affected the epidemiology of prostate cancer in the United States. Persistent racial disparities in outcomes for Black men warrant re-examination of the harms of screening relative to its cancer-specific mortality benefits in this population.MethodsWe estimated overdiagnoses and overtreatment of prostate cancer for men of all races and for Black men 50 to 84 years of age until 2016, the most recent year with treatment data available, using excess incidence relative to 1986 based on the Surveillance, Epidemiology, and End Results registry and U.S. Census data as well as an established microsimulation model of prostate cancer natural history. Combining estimates with plausible mortality benefit, we calculated numbers needed to diagnose (NND) and treat (NNT) to prevent one prostate cancer death.ResultsFor men of all races, we estimated 1.5 to 1.9 million (range between estimation approaches) overdiagnosed and 0.9 to 1.5 million overtreated prostate cancers by 2016. Assuming that half of the 270,000 prostate cancer deaths avoided by 2016 were attributable to screening, the NND and the NNT would be 11 to 14 and 7 to 11 for men of all races and 8 to 12 and 5 to 9 for Black men, respectively. Alternative estimates incorporating a lag between incidence and mortality resulted in a NND and a NNT for Black men that reached well into the low single digits.ConclusionsComplementary approaches to quantifying overdiagnosis indicate a harm-benefit tradeoff of prostate-specific antigen screening that is more favorable for Black men than for men of all races considered together. Our findings highlight the need to account for the increased value of screening in Black men in clinical guidelines. (Funded by the Patient-Centered Outcomes Research Institute, the National Cancer Institute, the Bristol Myers Squibb Foundation, and the Damon Runyon Cancer Research Foundation.)

Changing the Trajectory of Heart Failure and Kidney Disease: A Call for Action.

Changing the Trajectory of Heart Failure and Kidney Disease: A Call for Action.

MP28-08 BURDEN OF DEPRESSION AND ANXIETY IN MEN WITH HIGH-RISK, INTERMEDIATE-RISK OR LOW-RISK PROSTATE CANCER

You have accessJournal of UrologyCME1 May 2022MP28-08 BURDEN OF DEPRESSION AND ANXIETY IN MEN WITH HIGH-RISK, INTERMEDIATE-RISK OR LOW-RISK PROSTATE CANCER Sumedha Chhatre, S. Bruce Malkowicz, and Ravishankar Jayadevappa Sumedha ChhatreSumedha Chhatre More articles by this author , S. Bruce MalkowiczS. Bruce Malkowicz More articles by this author , and Ravishankar JayadevappaRavishankar Jayadevappa More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002571.08AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: While psychological difficulties such as depression and anxiety facing men with prostate cancer are acknowledged widely, they remain understudied. Objective was to assess the short-term and log-term burden of depression and anxiety by treatment type across different risk categories of prostate cancer. METHODS: We used data from a multi-centered randomized controlled study among localized prostate cancer patients. Outcomes were assessed at baseline, and at 3, 6, 12 and 24-month follow-up. Treatments were robotic-assisted laparoscopic radical prostatectomy, radiation therapy and active surveillance. Participants were categorized into risk groups as: low risk (PSA <10 ng/ml, Gleason ≤ 6, clinical stage T1-2a), intermediate risk (PSA 10 -20 ng/ml, Gleason 7, clinical stage T2b), and high risk (PSA > 20, Gleason ≥8, clinical stage T2c-3a). Depression was assessed using Center for Epidemiologic Studies Depression (CES-D) scale. CES-D score > 16 indicates depression. Anxiety was assessed using Scale for Prostate Cancer (MAX-PC). MAX-PC score > 27 indicates anxiety. Proportion of participants with depression and anxiety were compared by treatment type, for each prostate cancer risk category. RESULTS: Total of 743 localized prostate cancer patients were recruited for the study. Retention rate was > 75% during follow-up. 34% patients were low-risk, 32% were intermediate-risk and 34% were high-risk. For all risk groups, proportion of patients with depression increased between baseline and 24-month, for all treatment types. For low-risk group, at 24-month, proportion of patients on active surveillance who were depressed was lower than surgery and radiation groups (25% vs. 46% and 43%). For intermediate-risk and high risk-group, at 24-month, proportion of patients with depression was comparable between surgery and radiation. Similar pattern was observed for burden of anxiety. CONCLUSIONS: Ours is one of the largest randomized controlled study that has assessed the burden of depression and anxiety in localized prostate cancer patients. In our study, we observed that a substantial proportion of localized prostate cancer patients experienced depression and anxiety. Especially, in the follow-up period, the proportion of patients with depression and anxiety increased significantly. Future studies need to examine the effects of depression and anxiety on process of care and outcomes; and the pathways. Patient-centered survivorship care strategies are needed for reducing depression and anxiety and improving outcomes in prostate cancer care. Source of Funding: Patient-centered Outcomes Research Institute (PCORI) CE-12-11-4973 © 2022 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 207Issue Supplement 5May 2022Page: e463 Advertisement Copyright & Permissions© 2022 by American Urological Association Education and Research, Inc.MetricsAuthor Information Sumedha Chhatre More articles by this author S. Bruce Malkowicz More articles by this author Ravishankar Jayadevappa More articles by this author Expand All Advertisement PDF DownloadLoading ...

PD25-03 ASSOCIATION BETWEEN FINANCIAL BURDEN AND TREATMENT REGRET IN MEN WITH LOCALIZED PROSTATE CANCER

You have accessJournal of UrologyCME1 May 2022PD25-03 ASSOCIATION BETWEEN FINANCIAL BURDEN AND TREATMENT REGRET IN MEN WITH LOCALIZED PROSTATE CANCER Daniel D. Joyce, Christopher J. D. Wallis, Li-Ching Huang, Karen E. Hoffman, Zhiguo Zhao, Tatsuki Koyama, Ralph Conwill, David F. Penson, and Daniel A. Barocas Daniel D. JoyceDaniel D. Joyce More articles by this author , Christopher J. D. WallisChristopher J. D. Wallis More articles by this author , Li-Ching HuangLi-Ching Huang More articles by this author , Karen E. HoffmanKaren E. Hoffman More articles by this author , Zhiguo ZhaoZhiguo Zhao More articles by this author , Tatsuki KoyamaTatsuki Koyama More articles by this author , Ralph ConwillRalph Conwill More articles by this author , David F. PensonDavid F. Penson More articles by this author , and Daniel A. BarocasDaniel A. Barocas More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002567.03AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: We sought to understand the association between financial burden and treatment regret in men with localized prostate cancer to better understand the importance of inclusion of financial discussions in patient counseling. METHODS: Utilizing the multicenter, population-based Comparative Effectiveness Analysis of Surgery and Radiation (CEASAR) dataset, we identified all men accrued between 2011 and 2012 who underwent surgery, radiation, or active surveillance as primary management for localized prostate cancer. Patient-reported functional outcomes were assessed at baseline and longitudinally through 5 years using the 26-item Expanded Prostate Index Composite questionnaire. Treatment regret was assessed at 3- and 5-year follow-up using Clark’s validated scale. Financial burden was similarly evaluated at 3 and 5 years using a previously published 4-item questionnaire. The association between financial burden and treatment regret was assessed using multivariable logistic regression controlling for demographics, disease characteristics, treatment, functional outcomes, and patient expectations. RESULTS: Of the 2,924 men who met inclusion criteria, both regret and financial burden assessments were available for 80.6% (n=2,359). Prostate cancer management included surgery (n=1,256, 53.2%), radiation (n=787, 33.4%), and active surveillance (n=316, 13.4%). Financial burden from “finances in general” was associated with treatment regret at 3 and 5 years, after adjusting for potential confounders (OR 2.47, 95% CI 1.33, 4.57). Similar associations with financial burden from direct costs, such as treatment (OR 1.02, 95% CI 0.47, 2.21), clinic visit (OR 1.85, 95% CI 0.92, 3.71), and health insurance costs (OR 1.71, 95% CI 0.89, 3.30) were not observed (see Table). CONCLUSIONS: In this representative, population-based sample of men with localized prostate cancer, we observed associations between overall financial burden and treatment regret. The lack of association between treatment regret and measures of financial burden due to direct treatment costs may indicate a more profound impact on patients from indirect costs and should guide future efforts to address financial toxicity in prostate cancer management. Source of Funding: This study was supported by the Agency for Healthcare Research and Quality (1R01HS019356, 1R01HS022640) and the Patient-Centered Outcomes Research Institute (CE-12-11-4667). Data management was facilitated by Vanderbilt University’s Research Electronic Data Capture (REDCap) system, which is supported by the Vanderbilt Institute for Clinical and Translational Research grant (UL1TR000011 from NCATS/NIH) © 2022 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 207Issue Supplement 5May 2022Page: e422 Advertisement Copyright & Permissions© 2022 by American Urological Association Education and Research, Inc.MetricsAuthor Information Daniel D. Joyce More articles by this author Christopher J. D. Wallis More articles by this author Li-Ching Huang More articles by this author Karen E. Hoffman More articles by this author Zhiguo Zhao More articles by this author Tatsuki Koyama More articles by this author Ralph Conwill More articles by this author David F. Penson More articles by this author Daniel A. Barocas More articles by this author Expand All Advertisement PDF DownloadLoading ...

Translating research into policy and action.

Translating research into policy and action.

Reliever-Triggered Inhaled Glucocorticoid in Black and Latinx Adults with Asthma

BackgroundBlack and Latinx patients bear a disproportionate burden of asthma. Efforts to reduce the disproportionate morbidity have been mostly unsuccessful, and guideline recommendations have not been based on studies in these populations.MethodsIn this pragmatic, open-label trial, we randomly assigned Black and Latinx adults with moderate-to-severe asthma to use a patient-activated, reliever-triggered inhaled glucocorticoid strategy (beclomethasone dipropionate, 80 μg) plus usual care (intervention) or to continue usual care. Participants had one instructional visit followed by 15 monthly questionnaires. The primary end point was the annualized rate of severe asthma exacerbations. Secondary end points included monthly asthma control as measured with the Asthma Control Test (ACT; range, 5 [poor] to 25 [complete control]), quality of life as measured with the Asthma Symptom Utility Index (ASUI; range, 0 to 1, with lower scores indicating greater impairment), and participant-reported missed days of work, school, or usual activities. Safety was also assessed.ResultsOf 1201 adults (603 Black and 598 Latinx), 600 were assigned to the intervention group and 601 to the usual-care group. The annualized rate of severe asthma exacerbations was 0.69 (95% confidence interval [CI], 0.61 to 0.78) in the intervention group and 0.82 (95% CI, 0.73 to 0.92) in the usual-care group (hazard ratio, 0.85; 95% CI, 0.72 to 0.999; P=0.048). ACT scores increased by 3.4 points (95% CI, 3.1 to 3.6) in the intervention group and by 2.5 points (95% CI, 2.3 to 2.8) in the usual-care group (difference, 0.9; 95% CI, 0.5 to 1.2); ASUI scores increased by 0.12 points (95% CI, 0.11 to 0.13) and 0.08 points (95% CI, 0.07 to 0.09), respectively (difference, 0.04; 95% CI, 0.02 to 0.05). The annualized rate of missed days was 13.4 in the intervention group and 16.8 in the usual-care group (rate ratio, 0.80; 95% CI, 0.67 to 0.95). Serious adverse events occurred in 12.2% of the participants, with an even distribution between the groups.ConclusionsAmong Black and Latinx adults with moderate-to-severe asthma, provision of an inhaled glucocorticoid and one-time instruction on its use, added to usual care, led to a lower rate of severe asthma exacerbations. (Funded by the Patient-Centered Outcomes Research Institute and others; PREPARE ClinicalTrials.gov number, NCT02995733.)

Comparison of algorithms for identifying people with HIV from electronic medical records in a large, multi-site database.

ObjectiveAs electronic medical record (EMR) data are increasingly used in HIV clinical and epidemiologic research, accurately identifying people with HIV (PWH) from EMR data is paramount. We sought to evaluate EMR data types and compare EMR algorithms for identifying PWH in a multicenter EMR database.Materials and MethodsWe collected EMR data from 7 healthcare systems in the Chicago Area Patient-Centered Outcomes Research Network (CAPriCORN) including diagnosis codes, anti-retroviral therapy (ART), and laboratory test results.ResultsIn total, 13 935 patients had a positive laboratory test for HIV; 33 412 patients had a diagnosis code for HIV; and 17 725 patients were on ART. Only 8576 patients had evidence of HIV-positive status for all 3 data types (laboratory results, diagnosis code, and ART). A previously validated combination algorithm identified 22 411 patients as PWH.ConclusionEMR algorithms that combine laboratory results, administrative data, and ART can be applied to multicenter EMR data to identify PWH.

The Impact of COVID-19 on Patient, Family Member, and Stakeholder Research Engagement: Insights from the PREPARE NOW Study

BackgroundLittle is known about the impact of COVID-19 on patient, family member, and stakeholder patient-centered outcomes research engagement.ObjectiveTo answer the research questions: (1) What is the impact of COVID-19 on the lives of patients with kidney disease and their families? (2) What is the impact of COVID-19 on research engagement for patient and family member research team members who are themselves at very high risk for poor COVID-19 outcomes? and (3) How can we help patients, family members, and stakeholder team members engage in research during COVID-19?DesignWe conducted virtual semi-structured interviews with patient and family member co-investigators and kidney disease stakeholders from the PREPARE NOW study during November 2020. The interview guide included questions about participants’ experiences with the impact of COVID-19 on research engagement.ParticipantsSeven patient and family member co-investigators and eight kidney disease stakeholders involved in a kidney disease patient-centered outcomes research project participated in the interviews, data analysis, and writing this manuscript.ApproachWe used a content analysis approach and identified the main themes using an inductive process.Key ResultsRespondents reported three main ways that COVID-19 has impacted their lives: emotional impact, changing behaviors, and changes in health care delivery. The majority of respondents reported no negative impact of COVID-19 on their ability to engage in this research project. Suggestions for patient-centered outcomes research during COVID-19 and other emergencies include virtual research activities; active engagement; and promoting trust, honesty, transparency, and authenticity.ConclusionsCOVID-19 has had a significant negative impact on patient, family member, and stakeholder research team members; however, this has not resulted in less research engagement.Trial RegistrationClinicaltrials.gov NCT02722382

Understanding the Influence and Impact of Stakeholder Engagement in Patient-centered Outcomes Research: a Qualitative Study

BackgroundEngaging patients and other stakeholders as partners in research offers promise in improving the relevance and usefulness of research findings.ObjectiveTo explore the influence and impact of patient and other stakeholder engagement on the planning and conduct of comparative effectiveness research studies.DesignQualitative study with virtual, hour-long semi-structured interviews.ParticipantsFifty-eight researchers and fifty-one partners from a diverse purposeful sample of fifty-eight studies funded by the Patient-Centered Outcomes Research Institute (PCORI).ApproachContent and thematic analysis of interview data.Key ResultsDescribed as an integral, long-term part of the research process, engagement influenced all aspects of the design and execution of studies. Partner influence was also dynamic and iterative, taking different forms over the course of the study. Across studies, we identified 387 discrete examples of influence and classified each as one of five types of influence, derived inductively from the interview data: co-producing, redirecting, refining, confirming, and limited. Most projects exhibited multiple types of influence, with 50 researchers and 41 partners reporting two or more types of influence within a project. Of the 387 examples of stakeholder influence, 306 had at least one reported impact on the study. Such impacts included changes to reflect the needs and preferences of patients or clinicians, as well as impacts on study feasibility, study quality, engagement scope or quality, and study relevance. Both researchers and partners identified multiple types of impact within projects, with 42 researchers and 38 partners reporting two or more types within a project. Because of these observable impacts, researchers and partners described engagement as worthwhile.ConclusionsFindings provide insights for funders and institutions supporting engagement, measurement efforts, and clinical researchers aiming to conduct engaged research and observe similar influences and impacts in their own studies.

Developing and Implementing an mHealth Heart Failure Self-care Program to Reduce Readmissions: Randomized Controlled Trial.

BackgroundPatients admitted with decompensated heart failure (HF) are at risk for hospital readmission and poor quality of life during the discharge period. Lifestyle behavior modifications that promote the self-management of chronic cardiac diseases have been associated with an improved quality of life. However, whether a mobile health (mHealth) program can assist patients in the self-management of HF during the acute posthospital discharge period is unknown.ObjectiveWe aimed to develop an mHealth program designed to enhance patients’ self-management of HF by increasing knowledge, self-efficacy, and symptom detection. We hypothesized that patients hospitalized with HF would be willing to use a feasibly deployed mHealth program after their hospital discharge.MethodsWe employed a patient-centered outcomes research methodology to design a stakeholder-informed mHealth program. Adult patients with HF admitted to a large academic hospital were enrolled and randomized to receive the mHealth intervention versus usual care. Our feasibility outcomes included ease of program deployment, use of the clinical escalation process, duration of participant recruitment, and participant attrition. Surveys assessing the demographics and clinical characteristics of HF were measured at baseline and at 30 and 90 days after discharge.ResultsThe study period was between July 1, 2019, and April 7, 2020. The mean cohort (N=31) age was 60.4 (range 22-85) years. Over half of the participants were men (n=18, 58%) and 77% (n=24) were White. There were no significant differences in baseline measures. We determined that an educational mHealth program tailored for patients with HF is feasibly deployed and acceptable by patients. Though not significant, we found notable trends including a higher mean quality of life at 30 days posthospitalization among program users and a longer duration before rehospitalization, which are suggestive of better HF prognosis.ConclusionsOur mHealth tool should be further assessed in a larger comparative effectiveness trial. Our pilot intervention offers promise as an innovative means to help HF patients lead healthy, independent lives. These preliminary data suggest that patient-centered mHealth tools can enable high-risk patients to play a role in the management of their HF after discharge.Trial RegistrationClinicalTrials.gov NCT03982017; https://clinicaltrials.gov/ct2/show/NCT03982017

Augmenting Vs. Switching Antidepressant for Treatment Resistant Depression in Older adults: Results from the Optimum Study

This symposium will provide new information from a large, recently-completed comparative effectiveness trial called “OPTIMUM”, which studied augmentation vs. switch strategies for Treatment Resistant Depression (TRD) in older adults, yielding practical recommendations for treatment. Treatment resistance is common in older depressed adults, as ∼30% fail to remit with first-line antidepressant pharmacotherapies; namely SSRIs and SNRIs. Next-line strategies for TRD include augmentation with aripiprazole, augmentation with bupropion, and switch to bupropion. For those with higher levels of treatment resistance, older but well-known strategies are lithium augmentation and a switch to a secondary amine tricyclic (namely nortriptyline). Understanding the benefits vs. risk of these medication strategies is crucial for this population, which has high morbidity from depression but also significant risks from pharmacotherapy. The "Optimizing antidepressants for TRD in older adults" (OPTIMUM) study, funded by the Patient-Centered Outcomes Research Institute, is a 5-center collaboration that randomized 744 depressed individuals aged 60+ with TRD. It is the largest-ever clinical trial of TRD in older adults, with a similar design as the STAR*D and VAST-D studies that were conducted in younger adults. The OPTIMUM trial was a pragmatic trial conducted in the community, using measurement-based care support from the OPTIMUM team to guide patients through treatment. The study found that augmentation with aripiprazole and augmentation with bupropion had roughly similar effectiveness, and were more effective than switch to bupropion; in contrast, all three of these strategies were roughly equal in their risks such as falls and serious adverse events. In the second step of the trial, lithium augmentation and a switch to nortriptyline were roughly equivalent in both effectiveness and risks. After presenting the data on effectiveness and risk from this trial, the symposium speakers will distill these findings into practical recommendations for physicians in treating older adults and describe remaining, unmet challenges in our understanding of TRD treatment in older adults.

Optimizing Outcomes of Treatment-Resistant Depression (TRD) in Older Adults (OPTIMUM): Measures of Psychological Well-Being

<h3>Introduction</h3> The "Optimizing Antidepressants for Treatment-Resistant Depression in Older Adults" (OPTIMUM) study, funded by the Patient-Centered Outcomes Research Institute, is a 5-center collaboration that randomized 621 depressed individuals aged 60+ with treatment-resistant depression (TRD), the largest pharmacotherapy trial of TRD in late life. A key goal of this pragmatic trial was to measure outcomes of interest to patients, which in this trial included psychological wellbeing. This construct is closely tied to psychological and physical functioning and can be measured by self-report. <h3>Methods</h3> Participants were recruited and randomized if they were 60 years and older, met the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for Major Depressive Disorder, and had a score of 10 or higher on the Patient Health Questionnaire (PHQ-9), despite having been treated with at least two antidepressants with an adequate dosage and for at least four weeks (with previous psychotropic medications being different from the medications being testing in OPTIMUM). Upon study entry, participants were randomized to one of three strategies: augmentation with aripiprazole, augmentation with bupropion, or switch to bupropion. Treatment effectiveness was assessed using the Montgomery Asberg Rating Scale (MADRS) after ten weeks of treatment. Participants were also tested at the beginning and end of this 10-week step with the NIH Toolbox Psychological Well-being battery. Two wellbeing scales were used: positive affect (34 items) and general life satisfaction (16 items). Positive affect is characterized as happiness, contentment, and interest in pleasurable or achievement–relevant activities. Each item is scored on a 5-point scale ranging from "not at all" to "very much". General life satisfaction is the cognitive evaluation of life experiences; items assessing this concept are usually phrased in a general or global way rather than having a momentary or recent recall period. These items administered are scored on either a 5-point or 7-point scale ranging from "strongly disagree" to "strongly agree." <h3>Results</h3> Of the 621 study participants, 212 were randomized to augmentation with aripiprazole, 206 to augmentation with bupropion, and 203 to a switch to bupropion. Participants randomized to augmentation with either aripiprazole or bupropion showed a statistically significant improvement in their general life satisfaction subscale score (aripipirazole: 2.99, p< 0.0001; bupropion: 2.61, p=0.0001), while those switched to bupropion did not. Participants in either of the two augmentation arms also showed a statistically significant improvement in positive affect (aripiprazole: 5.35, p< 0.0001; bupropion: 5.02, p< 0.0001) while those switching to bupropion did not. <h3>Conclusions</h3> Among older adults with TRD, augmentation with aripiprazole or bupropion was associated with a statistically significant improvement in psychological well-being and positive affect, while a switch to bupropion monotherapy did not. Further research is needed to replicate findings. <h3>This research was funded by</h3> Patient-Centered Outcomes Research Institute (PCORI)

Creating a resident-centric rehabilitation research team

BackgroundThe 36-month Physical Medicine and Rehabilitation (PM&R) or Physiatry residency provides a number of multidisciplinary clinical experiences. These experiences often translate to novel research questions, which may not be pursued by residents due to several factors, including limited research exposure and uncertainty of how to begin a project.Limited resident participation in clinical researchnegatively affects the growth of Physiatry as a field and medicine as a whole. Thetwo largest Physiatry organizations – the Association of Academic Physiatristsand the American Academy of Physical Medicine and Rehabilitation – participate inthe Disability and Rehabilitation Research Coalition (DRRC), seeking to improvethe state of rehabilitation and disability research through fundingopportunities by way of the National Institutes of Health (NIH), the NationalInstitute on Disability, Independent Living and Rehabilitation Research(NIDILRR) and the Patient-Centered Outcomes Research Institute (PCORI). Apaucity of new Physiatry researchers neutralizes these efforts.ResultsThis paper detailsthe creation of a novel, multidisciplinary Rehabilitation Resident Researchprogram that promotes resident research culture and production. Mirroring ourcollaborative clinical care paradigm, this program integrates facultymentorship, institutional research collaborates (Neuroscience Nursing ResearchCenter, Neuroscience Research Development Office) and departmental resources(Shark Tank competition) to provide resident-centric research support.ConclusionsThe resident-centricrehabilitation research team has formed a successful research program that waspiloted from the resident perspective, facilitating academic productivity whilerespecting the clinical responsibilities of the 36-month PM&R residency. Residentresearch trainees are uniquely positioned to become future leaders ofmultidisciplinary and multispecialty collaborative teams, with a focus onpatient function and health outcomes.

The technical landscape for patient-centered CDS: progress, gaps, and challenges.

Supporting healthcare decision-making that is patient-centered and evidence-based requires investments in the development of tools and techniques for dissemination of patient-centered outcomes research findings via methods such as clinical decision support (CDS). This article explores the technical landscape for patient-centered CDS (PC CDS) and the gaps in making PC CDS more shareable, standards-based, and publicly available, with the goal of improving patient care and clinical outcomes. This landscape assessment used: (1) a technical expert panel; (2) a literature review; and (3) interviews with 18 CDS stakeholders. We identified 7 salient technical considerations that span 5 phases of PC CDS development. While progress has been made in the technical landscape, the field must advance standards for translating clinical guidelines into PC CDS, the standardization of CDS insertion points into the clinical workflow, and processes to capture, standardize, and integrate patient-generated health data.

Racial/Ethnic Disparities in Healthcare Worker Experiences During the COVID-19 Pandemic: An Analysis of the HERO Registry.

SummaryBackgroundThe extent to which healthcare worker (HCWs) experiences during the COVID-19 pandemic vary by race or ethnicity after adjustment for confounding factors is not currently known.MethodsWe performed an observational prospective cohort study of 24,769 healthcare workers from 50 U.S. states and the District of Columbia, enrolled between April 10, 2020 and June 30, 2021, and evaluated participant experiences during the COVID-19 pandemic, including testing, diagnosis with COVID-19, emotional experiences, burnout, and interest in vaccines and vaccine clinical trials.FindingsAfter adjustment for professional role, medical history, and community characteristics, Black and Asian participants were less likely to receive SARS-CoV-2 viral testing (adjusted odds ratio (aOR) 0·82 [0·70, 0·96], p=0·012 and aOR 0·77 [0·67, 0·89], p<0·001 respectively) than White participants. Hispanic participants were more likely to have evidence of COVID-19 infection (aOR 1·23 (1·00, 1·50, p=0·048). Black and Asian participants were less likely to report interest in a COVID-19 vaccine (aOR 0·11 [0·05, 0·25], p<0·001 and aOR 0·48 [0·27, 0·85] p=0·012). Black participants were less likely to report interest in participating in a COVID-19 vaccine trial (aOR = 0·39 [0·28, 0·54], p<0·001). Black participants were also less likely to report 3 or more daily emotional impacts of COVID-19 (aOR = 0·66 [0·53, 0·82], p=<0·001). Black participants were additionally less likely to report burnout (aOR = 0·66 ([0·49, 0·95], p=0·025).InterpretationIn a large, national study of healthcare workers, after adjustment for individual and community characteristics, race/ethnicity disparities in COVID-19 outcomes persist. Future work is urgently needed to understand precise mechanisms behind these disparities and to develop and implement targeted interventions to improve health equity for healthcare workers.FundingThis work was funded by the Patient-Centered Outcomes Research Institute (PCORI), Contract # COVID-19-2020-001.

The Aortic Dissection Collaborative: Methods for building capacity for patient-centered outcomes research in the aortic dissection community

Understanding what matters most to patients can help guide research in a direction that is best situated to provide evidence that is responsive to their core concerns. This can better inform the treatment decision-making process for patients and their physicians. The Aortic Dissection (AD) Collaborative built a collaborative AD research infrastructure involving patients and other stakeholders to facilitate patient-centered outcomes research training, support, and networking among those affected by AD. Two surveys and semi-structured interviews were conducted between January and October 2020 to gather information from people with and at risk for AD and their family members to better understand their experiences and needs. Discussion of survey and interview results were then articulated as seven key topics for future research to meet the needs of the AD community. Working groups were assembled to address each of the key topics. The groups conducted landscape reviews that were focused on providing guidance for future research that directly addresses the needs identified by the AD community. Recommendations for future research generated by the working groups were compiled by the Aortic Dissection Collaborative. From these recommendations, the Aortic Dissection Collaborative advisors and stakeholders identified high-priority research questions. The research questions form the basis for a third survey, disseminated to the Virtual Research Network between November 2021 and February 2022. Final analysis of the survey will identify top ranked research questions and assess willingness to participate. These results will inform the development of future patient-centered outcomes research and comparative effectiveness research proposals.

Multijurisdictional Analyses of Birth Defects: Considering the Common Data Model Approach.

Multijurisdictional Analyses of Birth Defects: Considering the Common Data Model Approach.

Advances in Stroke: Stroke in Women.

Advances in Stroke: Stroke in Women.

PCORI Engagement: Black People Like Me

African American (AA) populations bear a disproportionate burden of morbidity, mortality, and prevalence of asthma and COVID-19. Patients, clergy, and researchers developed a 6-month virtual conference to inform emerging research needs related to patients with asthma and / or COVID-19 to become participants in all aspects of patient-centered outcomes research.