Health system implementation of the PROMIS Cognitive Function Screener in the Medicare Annual Wellness Visit: framing as abilities versus concerns.

BACKGROUND: Cognitive assessment is a required component of the Medicare Annual Wellness Visit (AWV). In this prospective study, we evaluated acceptability and usefulness of a patient-reported outcome measure (the PROMIS® Cognitive Function Screener, or PRO-CS) to screen for cognitive impairment during the AWV. We compared two versions of the PRO-CS: Abilities and Concerns. METHODS: We developed PRO-CS Abilities and PRO-CS Concerns using items from the PROMIS Cognitive Function item banks. We partnered with a large health system in Pennsylvania to implement an electronic health record (EHR)-integrated version of the 4-item PRO-CS into their AWV workflow. PRO-CS Abilities was implemented in June 2022 and then replaced with PRO-CS Concerns in October 2022. We used EHR data to evaluate scores on Abilities versus Concerns and their association with patient characteristics. We gathered feedback from providers on experiences with the PRO-CS and conducted cognitive interviews with patients to evaluate their preferences for Abilities versus Concerns. RESULTS: Between June 2022 and January 2023, 3,088 patients completed PRO-CS Abilities and 2,614 patients completed PRO-CS Concerns. Mean T-scores for Abilities (54.8) were slightly higher (indicating better cognition) than for Concerns (52.6). 10% of scores on Abilities and 13% of scores on Concerns indicated concern for cognitive impairment (T-score < 45). Both Abilities and Concerns were associated with clinical characteristics as hypothesized, with lower scores for patients with cognitive impairment diagnoses and those requiring assistance with instrumental activities of daily living. Abilities and Concerns had similar negative correlations with depression (r= -0.31 versus r= -0.33) and anxiety (r= -0.28 for both), while Abilities had a slightly stronger positive correlation with self-rated health (r = 0.34 versus r = 0.28). In interviews, providers commented that the PRO-CS could be useful to facilitate conversations about cognition, though several providers noted potential limitations of patient self-report. Feedback from patients indicated a preference for PRO-CS Concerns. CONCLUSIONS: Our findings suggest potential utility of the PRO-CS for cognitive screening in the Medicare AWV. PRO-CS Abilities and Concerns had similar associations with patient clinical characteristics, but the Concerns version was more acceptable to patients.

Development of an ultra-short measure of eight domains of health-related quality of life for research and clinical care: the patient-reported outcomes measurement information system® PROMIS®-16 profile.

PURPOSE: We describe development of a short health-related quality of life measure, the patient-reported outcomes measurement information system® (PROMIS®)-16 Profile, which generates domain-specific scores for physical function, ability to participate in social roles and activities, anxiety, depression, sleep disturbance, pain interference, cognitive function, and fatigue. METHODS: An empirical evaluation of 50 candidate PROMIS items and item pairs was conducted using data from a sample of 5775 respondents from Amazon's Mechanical Turk (MTurk). Results and item response theory information curves for a subset of item pairs were presented and discussed in a stakeholder meeting to narrow the candidate item sets. A survey of the stakeholders and 124 MTurk adults was conducted to solicit preferences among remaining candidate items and finalize the measure. RESULTS: Empirical evaluation showed minimal differences in basic descriptive statistics (e.g., means, correlations) and associations with the PROMIS-29 + 2 Profile, thus item pairs were further considered primarily based on item properties and content. Stakeholders discussed and identified subsets of candidate item pairs for six domains, and final item pairs were agreed upon for two domains. Final items were selected based on stakeholder and MTurk-respondent preferences. The PROMIS-16 profile generates eight domain scores with strong psychometric properties. CONCLUSION: The PROMIS-16 Profile provides an attractive brief measure of eight distinct domains of health-related quality of life, representing an ideal screening tool for clinical care, which can help clinicians quickly identify distinct areas of concern that may require further assessment and follow-up. Further research is needed to confirm and extend these findings.

Parent Perceptions of Telemedicine for Acute Pediatric Respiratory Tract Infections: Sequential Mixed Methods Study.

BACKGROUND: Since 2020, parents have had increasing opportunities to use telemedicine for their children, but how parents decide whether to use telemedicine for acute pediatric care relative to alternative sites of care is not clear. One of the most common reasons parents seek acute care for their children is for acute respiratory tract infections (ARTIs). OBJECTIVE: This study aims to examine parental expectations of care via telemedicine for pediatric ARTIs, contrasting expectations of care delivered via primary care telemedicine and direct-to-consumer (DTC) telemedicine. METHODS: We performed a sequential mixed methods analysis to examine how parents assess telemedicine for their children's acute care. We used ARTIs as a case study for examining parent perceptions of telemedicine. First, we analyzed semistructured interviews focused on parent responses about the use of telemedicine. Each factor discussed by parents was coded to reflect whether parents indicated it incentivized or disincentivized their preferences for telemedicine versus in-person care. Results were organized by a 7-dimension framework of parental health care seeking that was generated previously, which included dimensions related to care sites (expected access, affordability, clinical quality, and site quality) and dimensions related to child or family factors (perceived illness severity, perceived child susceptibility, and parent self-efficacy). Second, we analyzed responses to a national survey, which inquired about parental expectations of primary care telemedicine, commercial DTC telemedicine, and 3 in-person sites of care (primary care, urgent care, and emergency department) across 21 factors identified through prior qualitative work. To assess whether parents had different expectations of different telemedicine models, we compared survey responses for primary care telemedicine and commercial DTC telemedicine using weighted logistic regression. RESULTS: Interview participants (n=40) described factors affecting their perceptions of telemedicine as a care modality for pediatric ARTIs. Generally, factors aligned with access and affordability (eg, decreased wait time and lower out-of-pocket cost) were discussed as potential incentives for telemedicine use, while factors aligned with perceived illness severity, child susceptibility, and clinician quality (eg, trustworthiness) were discussed as potential disincentives for telemedicine use. In survey responses (n=1206), primary care and commercial DTC telemedicine were rated similarly on items related to expected accessibility and affordability. In contrast, on items related to expected quality of care, primary care telemedicine was viewed similarly to in-person primary care, while commercial DTC telemedicine was rated lower. For example, 69.7% (weighted; 842/1197) of respondents anticipated their children would be comfortable and cooperative with primary care telemedicine versus 49.7% (weighted; 584/1193) with commercial DTC telemedicine (P<.001). CONCLUSIONS: In a mixed methods analysis focused on telemedicine for ARTIs, parents expressed more concerns about telemedicine quality in commercial DTC models compared with primary care-based telemedicine. These results could help health systems better design telemedicine initiatives to support family-centered care.

Accuracy of a Single Financial Security Question to Screen for Social Needs.

OBJECTIVES: Screening for social needs is recommended during clinical encounters but multi-item questionnaires can be burdensome. We evaluate if a single question about financial stress can be used to prescreen for food insecurity, housing instability, or transportation needs. METHODS: We use retrospective medical record data from children (<11 years) seen at 45 primary pediatric care offices in 2022. Social needs screening was automated at well child visits and could be completed by the parent/guardian via the patient portal, tablet in the waiting room, or verbally with staff. We report the area under the receiver operating curve for the 5 response options of the financial stress question as well as sensitivity and specificity of the financial stress question ("not hard at all" vs any other response) to detect other reported social needs. RESULTS: Of 137 261 eligible children, 130 414 (95.0%) had social needs data collected. Seventeen percent of respondents reported a housing, food, or transportation need. The sensitivity of the financial stress question was 0.788 for any one or more of the 3 other needs, 0.763 for food insecurity, 0.743 for housing instability, and 0.712 for transportation needs. Using the financial stress question as the first-step of a screening process would miss 9.7% of the families who reported food insecurity, 22.6% who reported housing instability, and 33.0% who reported transportation needs. CONCLUSIONS: A single question screener about financial stress does not function well as a prescreen because of low sensitivity to reports of food insecurity, housing instability, and transportation needs.

Preferences for risks and benefits of treatment outcomes for chronic low back pain: Choice-based conjoint measure development and discrete choice experiment.

INTRODUCTION: Understanding individual patient preferences for chronic low back pain (cLBP) outcomes is essential for targeting available therapeutic options; yet tools to elicit patient outcome preferences are limited. OBJECTIVE: To develop and test a choice-based conjoint (CBC) measure, commonly used in behavioral economics research, to elicit what outcomes patients with cLBP want to achieve and avoid. DESIGN: We developed a survey-based CBC measure to allow patients to make risk/benefit trade-off choices between possible treatment outcomes. After extensive literature, clinician, and patient input, our measure included seven attributes: fatigue, anxiety/depression, difficulty thinking/making decisions, pain intensity, physical abilities, change in pain, and ability to enjoy life despite pain. Random-parameters logit models were used to estimate strength of preferences, and latent class analysis was used to identify patient characteristics associated with distinct preference. SETTING: Online study using the Sawtooth web-based platform. PARTICIPANTS: Two hundred eleven individuals with cLBP recruited from online advertising as well as at clinical sites across multiple academic and private institutions. INTERVENTIONS: Not applicable. RESULTS: The most valued outcome was the highest level of physical activity (ß = 1.6-1.98; p < .001), followed by avoiding cognitive difficulties (ß = -1.48; p < .001). Avoidance of severe pain was comparable to avoiding constant fatigue and near-constant depression/anxiety (ß = -0.99, -1.02); p < .001). There was an association between preferences and current pain/disability status; patients with higher pain had a stronger preference to avoid severe pain, whereas those with higher disability have stronger preferences for achieving physical activity. The latent class analysis identified two distinct groups: (1) more risk-seeking and willing to accept worse outcomes (56%); and (2) more risk-averse with a stronger preference for achieving maximum benefits (44%). CONCLUSIONS: Our study illuminated cLBP patient preferences for treatment outcomes and heterogeneity in these preferences. Patients stressed the importance of reaching high physical activity and avoiding cognitive declines, even over a desire to avoid pain. More work is needed to understand patient preferences to aid informed, shared decisions.

Electronic health record (EHR)-based PROMIS measures among neurology clinic decedents and survivors: a retrospective cohort analysis.

BACKGROUND: In addition to their standard use to assess real-time symptom burden, patient-reported outcomes (PROs), such as the Patient-Reported Outcomes Measurement Information System (PROMIS), measures offer a potential opportunity to understand when patients are experiencing meaningful clinical decline. If PROs can be used to assess decline, such information can be used for informing medical decision making and determining patient-centered treatment pathways. We sought to use clinically implemented PROMIS measures to retrospectively characterize the final PROMIS report among all patients who completed at least one PROMIS assessment from December 2017-March 2020 in one large health system, stratified by decedents vs. survivors. We conducted a retrospective cohort analysis of decedents (N = 1,499) who received care from outpatient neurology clinical practice within a single, large health system as part of usual care. We also compared decedents to survivors (360 + days before death; N = 49,602) on PROMIS domains and PROMIS-Preference (PROPr) score, along with demographics and clinical characteristics. We used electronic health record (EHR) data with built-in PROMIS measures. Linear regressions assessed differences in PROMIS domains and aggregate PROPr score by days before death of the final PROMIS completion for each patient. RESULTS: Among decedents in our sample, in multivariable regression, only fatigue (range 54.48-59.38, p < 0.0029) and physical function (range 33.22-38.38, p < 0.0001) demonstrated clinically meaningful differences across time before death. The overall PROPr score also demonstrated statistically significant difference comparing survivors (0.19) to PROPr scores obtained 0-29 days before death (0.29, p < 0.0001). CONCLUSIONS: Although clinic completion of PROMIS measures was near universal, very few patients had more than one instance of PROMIS measures reported, limiting longitudinal analyses. Therefore, patient-reported outcomes in clinical practice may not yet be robust enough for incorporation in prediction models and assessment of trajectories of decline, as evidenced in these specialty clinics in one health system. PROMIS measures can be used to effectively identify symptoms and needs in real time, and robust incorporation into EHRs can improve patient-level outcomes, but further work is needed for them to offer meaningful inputs for defining patient trajectories near the end of life. Assessing symptom burden provides an opportunity to understand clinical decline, particularly as people approach the end of life. We sought to understand whether symptoms reported by patients can be used to assess decline in health. Such information can inform decision-making about care and treatments. Of eight symptoms that we assessed, patient reports of fatigue and physical function were associated with clinical decline, as was an overall score of symptom burden. Because few symptoms were associated with decline, patient-reported outcomes in clinical practice may not yet be robust enough for incorporation in prediction models and assessment of trajectories of decline.

Understanding the measurement relationship between EQ-5D-5L, PROMIS-29 and PROPr.

PURPOSE: Many generic patient-reported instruments are available for the measurement of health outcomes, including EQ-5D-5L, and the Patient-Reported Outcome Measurement Information System (PROMIS). Assessing their measurement characteristics informs users about the consistency between, and limits of, evidence produced. The aim was to assess the measurement relationship between the EQ-5D-5L descriptive system and value sets, the PROMIS-29 and PROPr (PROMIS value set). METHODS: Data were extracted from a cross-sectional survey administering measures of quality of life online in Australia. Descriptive analysis, agreement and construct validity assessment methods were used to compare instruments at the item, domain and value set level. RESULTS: In total, 794 Australians completed the survey. Convergent validity analysis found that similar dimensions across instruments were highly correlated (> 0.50), but the PROMIS-29 assesses additional health concepts not explicitly covered by EQ-5D (sleep and fatigue). Known-group assessment found that EQ-5D-5L and PROPr were able to detect those with and without a condition (ES range 0.78-0.83) but PROPr could more precisely detect differing levels of self-reported health. Both instruments were sensitive to differences in levels of pain. DISCUSSION: There is some consistency in what the EQ-5D-5L, PROMIS-29 and PROPr measure. Differences between value set characteristics can be linked to differences what is measured and the valuation approaches used. This has implications for the use of each in assessing health outcomes, and the results can inform decisions about which instrument should be used in which context.

Emotional Well-Being: What It Is and Why It Matters.

Psychological aspects of well-being are increasingly recognized and studied as fundamental components of healthy human functioning. However, this body of work is fragmented, with many different conceptualizations and terms being used (e.g., subjective well-being, psychological well-being). We describe the development of a provisional conceptualization of this form of well-being, here termed emotional well-being (EWB), leveraging prior conceptual and theoretical approaches. Our developmental process included review of related concepts and definitions from multiple disciplines, engagement with subject matter experts, consideration of essential properties across definitions, and concept mapping. Our conceptualization provides insight into key strengths and gaps in existing perspectives on this form of well-being, setting a foundation for evaluating assessment approaches, enhancing our understanding of the causes and consequences of EWB, and, ultimately, developing effective intervention strategies that promote EWB. We argue that this foundation is essential for developing a more cohesive and informative body of work on EWB. Supplementary Information: The online version contains supplementary material available at 10.1007/s42761-022-00163-0.

A Perfect Storm to Set the Stage for Ontological Exploration: Response to Commentaries on "Emotional Well-Being: What It Is and Why It Matters".

Our target article (Park et al., this issue) described the process of developing a provisional conceptualization of emotional well-being (EWB). In that article, we considered strengths and gaps in current perspectives on a variety of related concepts and ways that the proposed conceptualization of EWB informs our evaluation of measures and methods of assessment and identification of its causes and consequences. We concluded with recommendations for moving the framework and the field forward. Eight rich, thoughtful, and highly engaged commentaries addressed the target article. Collectively, these commentaries illustrate both points of consensus and areas of substantial disagreement, providing a potential roadmap for continued work. In this response, we summarize key issues raised and highlight those points raised by multiple commentators or that we considered seminal to advancing future discussion and research.

CAPER: patient preferences to inform nonsurgical treatment of chronic low back pain: a discrete-choice experiment.

OBJECTIVE: We developed and used a discrete-choice measure to study patient preferences with regard to the risks and benefits of nonsurgical treatments when they are making treatment selections for chronic low back pain. METHODS: "CAPER TREATMENT" (Leslie Wilson) was developed with standard choice-based conjoint procedures (discrete-choice methodology that mimics an individual's decision-making process). After expert input and pilot testing, our final measure had 7 attributes (chance of pain relief, duration of relief, physical activity changes, treatment method, treatment type, treatment time burden, and risks of treatment) with 3-4 levels each. Using Sawtooth software (Sawtooth Software, Inc., Provo, UT, USA), we created a random, full-profile, balanced-overlap experimental design. Respondents (n = 211) were recruited via an emailed online link and completed 14 choice-based conjoint choice pairs; 2 fixed questions; and demographic, clinical, and quality-of-life questions. Analysis was performed with random-parameters multinomial logit with 1000 Halton draws. RESULTS: Patients cared most about the chance of pain relief, followed closely by improving physical activity, even more than duration of pain relief. There was comparatively less concern about time commitment and risks. Gender and socioeconomic status influenced preferences, especially with relation to strength of expectations for outcomes. Patients experiencing a low level of pain (Pain, Enjoyment, and General Activity Scale [PEG], question 1, numeric rating scale score<4) had a stronger desire for maximally improved physical activity, whereas those in a high level of pain (PEG, question 1, numeric rating scale score>6) preferred both maximum and more limited activity. Highly disabled patients (Oswestry Disability Index score>40) demonstrated distinctly different preferences, placing more weight on achieving pain control and less on improving physical activity. CONCLUSIONS: Individuals with chronic low back pain were willing to trade risks and inconveniences for better pain control and physical activity. Additionally, different preference phenotypes exist, which suggests a need for clinicians to target treatments to particular patients.

Parent-Reported Use of Pediatric Primary Care Telemedicine: Survey Study.

BACKGROUND: Telemedicine delivered from primary care practices became widely available for children during the COVID-19 pandemic. OBJECTIVE: Focusing on children with a usual source of care, we aimed to examine factors associated with use of primary care telemedicine. METHODS: In February 2022, we surveyed parents of children aged ≤17 years on the AmeriSpeak panel, a probability-based panel of representative US households, about their children's telemedicine use. We first compared sociodemographic factors among respondents who did and did not report a usual source of care for their children. Among those reporting a usual source of care, we used Rao-Scott F tests to examine factors associated with parent-reported use versus nonuse of primary care telemedicine for their children. RESULTS: Of 1206 respondents, 1054 reported a usual source of care for their children. Of these respondents, 301 of 1054 (weighted percentage 28%) reported primary care telemedicine visits for their children. Factors associated with primary care telemedicine use versus nonuse included having a child with a chronic medical condition (87/301, weighted percentage 27% vs 113/753, 15%, respectively; P=.002), metropolitan residence (262/301, weighted percentage 88% vs 598/753, 78%, respectively; P=.004), greater internet connectivity concerns (60/301, weighted percentage 24% vs 116/753, 16%, respectively; P=.05), and greater health literacy (285/301, weighted percentage 96% vs 693/753, 91%, respectively; P=.005). CONCLUSIONS: In a national sample of respondents with a usual source of care for their children, approximately one-quarter reported use of primary care telemedicine for their children as of 2022. Equitable access to primary care telemedicine may be enhanced by promoting access to primary care, sustaining payment for primary care telemedicine, addressing barriers in nonmetropolitan practices, and designing for lower health-literacy populations.

A Roadmap for Increasing the Usefulness and Impact of Patient-Preference Studies in Decision Making in Health: A Good Practices Report of an ISPOR Task Force.

Many qualitative and quantitative methods are readily available to study patient preferences in health. These methods are now being used to inform a wide variety of decisions, and there is a growing body of evidence showing studies of patient preferences can be used for decision making in a wide variety of contexts. This ISPOR Task Force report synthesizes current good practices for increasing the usefulness and impact of patient-preference studies in decision making. We provide the ISPOR Roadmap for Patient Preferences in Decision Making that invites patient-preference researchers to work with decision makers, patients and patient groups, and other stakeholders to ensure that studies are useful and impactful. The ISPOR Roadmap consists of 5 key elements: (1) context, (2) purpose, (3) population, (4) method, and (5) impact. In this report, we define these 5 elements and provide good practices on how patient-preference researchers and others can actively contribute to increasing the usefulness and impact of patient-preference studies in decision making. We also present a set of key questions that can support researchers and other stakeholders (eg, funders, reviewers, readers) to assess efforts that promote the ongoing impact (both intended and unintended) of a particular preference study and additional studies in the future.

Eliminating Food Insecurity in the USA: a Target Trial Emulation Using Observational Data to Estimate Effects on Health-Related Quality of Life.

BACKGROUND: Food insecurity is associated with many aspects of poor health. However, trials of food insecurity interventions typically focus on outcomes of interest to funders, such as healthcare use, cost, or clinical performance metrics, rather than quality of life outcomes that may be prioritized by individuals who experience food insecurity. OBJECTIVE: To emulate a trial of a food insecurity elimination intervention, and quantify its estimated effects on health utility, health-related quality of life, and mental health. DESIGN: Target trial emulation using longitudinal, nationally representative data, from the USA, 2016-2017. PARTICIPANTS: A total of 2013 adults in the Medical Expenditure Panel Survey screened positive for food insecurity, representing 32 million individuals. MAIN MEASURES: Food insecurity was assessed using the Adult Food Security Survey Module. The primary outcome was the SF-6D (Short-Form Six Dimension) measure of health utility. Secondary outcomes were mental component score (MCS) and physical component score (PCS) of the Veterans RAND 12-Item Health Survey (a measure of health-related quality of life), Kessler 6 (K6) psychological distress, and Patient Health Questionnaire 2-item (PHQ2) depressive symptoms. KEY RESULTS: We estimated that food insecurity elimination would improve health utility by 80 QALYs per 100,000 person-years, or 0.008 QALYs per person per year (95% CI 0.002 to 0.014, p = 0.005), relative to the status quo. We also estimated that food insecurity elimination would improve mental health (difference in MCS [95% CI]: 0.55 [0.14 to 0.96]), physical health (difference in PCS: 0.44 [0.06 to 0.82]), psychological distress (difference in K6: -0.30 [-0.51 to -0.09]), and depressive symptoms (difference in PHQ-2: -0.13 [-0.20 to -0.07]). CONCLUSIONS: Food insecurity elimination may improve important, but understudied, aspects of health. Evaluations of food insecurity interventions should holistically investigate their potential to improve many different aspects of health.

Estimates of Quality-Adjusted Life-Year Loss for Injuries in the United States.

PURPOSE: The goal of this study is to develop an approach for estimating nationally representative quality-adjusted life-year (QALY) loss from injury and poisoning conditions using data collected in the Medical Expenditure Panel Survey (MEPS) and the National Health Interview Survey (NHIS). METHODS: This study uses data from the 2002-2015 NHIS and MEPS surveys. Injuries were identified in the MEPS medical events file and through self-reporting of medical conditions. We restricted our model to 163,731 adults, for which we predict a total of 294,977 EQ-5D scores using responses to the self-administered questionnaire. EQ-5D scores were modeled using age, sex, comorbidities, and binary indicators of the presence and duration of injury at the time of the health status questionnaire. These models consider nonlinearity over time during the first 3 y following the injury event. RESULTS: Injuries are identified in MEPS using medical events that provide a reasonable proxy for the date of injury occurrence. Health-related quality of life (HRQL) decrements can be estimated using binary indicators of injury during different time periods. When grouped into 29 injury categories, most categories were statistically significant predictors of HRQL scores in the first year after injury. For these groups of injuries, mean first-year QALY loss estimates range from 0.005 (sprains and strains of joints and adjacent muscles, n = 7067) to 0.109 (injury to nerves and spinal cord, n = 71). Fewer estimates are significant in the second and third years after injury, which may reflect a return to baseline HRQL. CONCLUSION: This research presents both a framework for estimating QALY loss for short-lived medical conditions and nationally representative, community-based HRQL scores associated with a wide variety of injury and poisoning conditions. HIGHLIGHTS: This research provides a catalog of nationally representative, preference-based EQ-5D score decrements associated with surviving a large set of injuries, based on patient-reported health status.Mean first-year QALY loss estimates range from 0.005 (sprains and strains of joints and adjacent muscles, n = 7067) to 0.109 (injury to nerves and spinal cord, n = 71).This article presents a novel methodology for assessing quality-of-life impacts for acute conditions by calculating the time elapsed between injury and health status elicitation. Researchers may explore adapting these methods to study other short-lived conditions and health states, such as COVID-19 or chemotherapy.

Two-step screening for depressive symptoms in patients treated with kidney replacement therapies: a cross-sectional analysis.

BACKGROUND: Systematic screening for depressive symptoms may identify patients who may benefit from clinical assessment and psychosocial support. Here we assess a two-step screening using ultrabrief pre-screeners [Edmonton Symptom Assessment Survey-revised Depression item (ESASr-D) or Patient Health Questionnaire-2 (PHQ-2)] followed by the Patient-Reported Outcomes Measurement Information System Depression questionnaire (PROMIS-D) to identify depressive symptoms in patients on kidney replacement therapies. METHODS: We conducted a cross-sectional study of adults (kidney transplant recipients or treated with dialysis) in Toronto, ON, Canada. We simulated various two-step screening scenarios where only patients above a pre-screening cut-off score on the ESASr-D or PHQ-2 would move to step 2 (PROMIS-D). Screening performance was evaluated by sensitivity, specificity and positive and negative predictive values using the Patient Health Questionnaire-9 (PHQ-9) as the referent. The average number of items completed by patients in different scenarios was reported. RESULTS: Of 480 participants, 60% were male with a mean age of 55 years. Based on PHQ-9, 19% of patients had moderate or severe depressive symptoms. Pre-screening with a PHQ-2 score ≥1 combined with a PROMIS-D score of ≥53 provided the best two-step results (sensitivity 0.81, specificity 0.84, NPV 0.95). Two-step screening also reduces question burden. CONCLUSIONS: A two-step screening using a PHQ-2 score ≥1 followed by a PROMIS-D score ≥53 has good sensitivity and specificity for identifying potentially significant depressive symptoms among patients on kidney replacement therapies. This approach has lower question burden. Screened-in patients will need further clinical assessment to establish a diagnosis.

Phase I trial of pembrolizumab plus vemurafenib and cobimetinib in patients with metastatic melanoma.

Background: Preclinical and translational evidence suggest BRAF/MEK inhibitors modulate the tumor microenvironment (TME), providing rationale for combination with immunotherapy. Methods: This investigator-initiated, phase I trial evaluated pembrolizumab, vemurafenib, and cobimetinib in patients with untreated, BRAFV600E/K mutant advanced melanoma. The first 4 patients received vemurafenib with pembrolizumab, and the next 5 patients received vemurafenib and cobimetinib with pembrolizumab. Primary endpoints: safety and maximum tolerated dose of the triplet. Secondary endpoints: objective response rate (ORR), progression-free survival (PFS), overall survival (OS), and quality of life (QoL). The trial was closed after enrollment of 9 (planned 30) patients due to dose-limiting toxicity (DLT). Study NCT02818023 was approved by the IRB, and all patients provided informed consent. Results: Patients received a median of 6 cycles of therapy. 8 of 9 experienced drug-related grade 3/4 AEs. DLTs included dermatitis (n=8), hepatitis (n=1), QTc prolongation (n=1), and arthralgias (n=1 each). QoL assessments identified a clinically significant decrease in self assessed QoL at 1 year compared to baseline (0.38 v 0.43). Median PFS was 20.7 months and median OS was 23.8 months for vemurafenib with pembrolizumab. Median PFS and OS were not reached for patients receiving triple therapy. ORR in the overall cohort was 78% (7/9). 2 patients experienced a complete response, 5 had a partial response, 1 had stable disease, and 1 had progressive disease. 4 patients had ongoing responses at data analysis. Peripheral blood flow cytometry identified significantly decreased PD1 expression on CD4+ T-cells at 3 and 9 weeks compared to baseline, not corresponding to clinical response. Conclusions: Triple therapy with vemurafenib, cobimetinib and pembrolizumab is associated with high response rates but significant adverse events, leading to early study closure.

Do patients want clinicians to ask about social needs and include this information in their medical record?

BACKGROUND: Social needs screening in primary care may be valuable for addressing non-medical health-related factors, such as housing insecurity, that interfere with optimal medical care. Yet it is unclear if patients welcome such screening and how comfortable they are having this information included in electronic health records (EHR). OBJECTIVE: To assess patient attitudes toward inclusion of social needs information in the EHR and key correlates, such as sociodemographic status, self-rated health, and trust in health care. DESIGN, PARTICIPANTS, AND MAIN MEASURES: In a cross-sectional survey of patients attending a primary care clinic for annual or employment exams, 218/560 (38%) consented and completed a web survey or personal interview between 8/20/20-8/23/21. Patients provided social needs information using the Accountable Care Communities Screening Tool. For the primary outcome, patients were asked, "Would you be comfortable having these kinds of needs included in your health record (also known as your medical record or chart)?" ANALYSES: Regression models were estimated to assess correlates of patient comfort with including social needs information in medical records. KEY RESULTS: The median age was 45, 68.8% were female, and 78% were white. Median income was $75,000 and 84% reported education beyond high school. 85% of patients reported they were very or somewhat comfortable with questions about social needs, including patients reporting social needs. Social need ranged from 5.5% (utilities) to 26.6% (housing), and nonwhite and gender-nonconforming patients reported greater need. 20% reported "some" or "complete" discomfort with social needs information included in the EHR. Adjusting for age, gender, race, education, trust, and self-rated health, each additional reported social need significantly increased discomfort with the EHR for documenting social needs. CONCLUSIONS: People with greater social needs were more wary of having this information placed in the EHR. This is a concerning finding, since one rationale for collecting social need data is to use this information (presumably in the EHR) for addressing needs.

Evaluation of PROMIS Cognitive Function Scores and Correlates in a Clinical Sample of Older Adults.

In this study we assessed the utility of self-reported cognitive function using two PROMIS® Cognitive Function (PROMIS-CF) items in an observational clinical sample of patients aged 65 and older (n = 16,249) at a large health system. We evaluated the association of PROMIS-CF scores with clinical characteristics and Montreal Cognitive Assessment (MoCA) scores, and we used logistic regression to examine predictors of 1-year decline in PROMIS-CF scores among patients with available data. PROMIS-CF scores were associated with clinical characteristics as hypothesized, with lower (more impaired) scores for patients with cognitive impairment (CI) diagnoses, multiple comorbidities, and those taking cognitive enhancing or interfering medications. PROMIS-CF scores were also positively associated with MoCA scores. Predictors of 1-year decline in PROMIS-CF scores included CI diagnoses, use of cognitive enhancing medications, higher depression scores, and lower social role function. Our findings suggest potential utility of PROMIS-CF items in a brief patient-administered screening tool for CI.

A scoping review of US insurers' use of patient-reported outcomes.

OBJECTIVES: To complete a scoping review of US health insurers' use of health-related quality of life (HRQOL) patient-reported outcome measures (PROMs). STUDY DESIGN: Literature review. METHODS: A literature search was constructed for articles that contained an insurer-related term and an HRQOL-related term between 1999 and 2019 using the MEDLINE, Embase, Web of Science, Cochrane Database of Systematic Reviews, EconLit, and Business Source Complete databases. RESULTS: The search identified 14,253 unduplicated records, of which 2340 passed abstract screening and 350 were included in the review. The populations addressed in these studies included both populations with specific health conditions (eg, diabetes) and an entire member population. The most common purpose of the article was to evaluate a policy or program (n = 255; 72.9%); the range of interventions evaluated included federal policy, subgroup management strategies, and identification of individual patients. The most common insurance mechanism was Medicare (n = 205; 58.6%). The most common source of data was collected specifically for a research project (n = 172; 49.1%), and the least common source of data was collected by providers at the point of care (n = 34; 9.7%). The most commonly addressed age group was 65 years and older (n = 262; 74.9%), and the least commonly addressed was younger than 18 years (n = 36; 10.3%). The most commonly used PROMs were single-item self-rated health (n = 138; 47.1%) and activities of daily living (n = 88; 30.0%), with validated depression questionnaires (n = 56; 19.1%) being the most common disease-focused questionnaire. CONCLUSIONS: This review found a wide variety of articles across insurance providers, health conditions, and uses of PROMs. There is a noted paucity of data in pediatric populations and little information about the use of data collected within health care settings that is transmitted to health insurers.