Factor Analysis in Distinguishing Coronavirus Disease 2019 From Other Influenza-like Illness Using a Validated Patient-Reported Outcome Instrument FLU-PRO Plus: A Prospective Real-world Cohort Study.

BACKGROUND/OBJECTIVE: InFLUenza Patient-reported Outcome (FLU-PRO Plus) is a 34-item patient-reported outcome instrument designed to capture the intensity and frequency of viral respiratory symptoms. This study evaluates whether FLU-PRO Plus responses could discriminate between symptoms of coronavirus disease 2019 (COVID-19) and influenza-like illness (ILI) with no COVID diagnosis, as well as forecast disease progression. METHODS: FLU-PRO Plus was administered daily for 14 days. Exploratory factor analysis was used to reduce the FLU-PRO Plus responses on the first day to 3 factors interpreted as "symptom clusters." The 3 clusters were used to predict COVID-19 versus ILI diagnosis in logistic regression. Correlation between the clusters and quality of life (QoL) measures was used to assess concurrent validity. The timing of self-reported return to usual health in the 14-day period was estimated as a function of the clusters within COVID-19 and ILI groups. RESULTS: Three hundred fourteen patients completed day 1 FLU-PRO Plus, of which 65% had a COVID-19 diagnosis. Exploratory factor analysis identified 3 symptom clusters: (1)general Body, (2) tracheal/bronchial, and (3) nasopharyngeal. Higher nasopharyngeal scores were associated with higher odds of COVID-19 compared with ILI diagnosis [adjusted odds ratio = 1.61 (1.21, 2.12)]. Higher tracheal/bronchial scores were associated with lower odds of COVID-19 [0.58 (0.44, 0.77)]. The 3 symptom clusters were correlated with multiple QoL measures ( r = 0.14-0.56). Higher scores on the general body and tracheal/bronchial symptom clusters were associated with prolonged time to return to usual health [adjusted hazard ratios: 0.76 (0.64, 0.91), 0.80 (0.67, 0.96)]. CONCLUSION: Three symptom clusters identified from FLU-PRO Plus responses successfully discriminated patients with COVID-19 from non-COVID ILI and were associated with QoL and predicted symptom duration.

Connecting Vietnamese-Speaking Immigrants who Smoke to the Asian Smokers Quitline: A Feasibility Pilot of Proactive Outreach Interventions.

INTRODUCTION: Cigarette smoking is highly prevalent among Asian American immigrant subgroups. Previously, Asian-language telephone Quitline services were only available in California. In 2012, the Centers for Disease Control and Prevention (CDC) funded the national Asian Smokers' Quitline (ASQ) to expand Asian-language Quitline services nationally. However, there are relatively few calls to the ASQ from outside California. AIMS AND METHODS: This pilot study assessed the feasibility of two proactive outreach interventions to connect Vietnamese-speaking participants who smoke to the ASQ. Both interventions, (1) proactive telephone outreach with a counselor trained in motivational interviewing (PRO-MI) and (2) proactive telephone outreach with interactive voice response (PRO-IVR), were adapted to be culturally and linguistically appropriate for Vietnamese-speaking participants. Participants were randomly assigned 2:1 to PRO-IVR versus PRO-MI. Assessments were conducted at baseline and 3 months post-enrollment. Feasibility indicators were the recruitment rate and initiation of ASQ treatment. RESULTS: Using the HealthPartners electronic health record, a large health system in Minnesota, we identified approximately 343 potentially eligible Vietnamese participants who were mailed invitation letters and baseline surveys with telephone follow-up. We enrolled 86 eligible participants (25% recruitment rate). In the PRO-IVR group 7/58 participants were directly transferred to the ASQ (12% initiation rate) and in the PRO-MI group 8/28 participants were warm transferred to the ASQ (29% initiation rate). CONCLUSIONS: This pilot study demonstrates the feasibility of our recruitment methods and of implementing proactive outreach interventions to promote the initiation of smoking cessation treatment with the ASQ. IMPLICATIONS: This pilot study contributes novel data on the uptake of Asian Smokers' Quitline (ASQ) services among Vietnamese-speaking people who smoke (PWS) with two proactive outreach interventions: (1) proactive telephone outreach with a counselor trained in motivational interviewing (PRO-MI) and (2) proactive telephone outreach with interactive voice response (PRO-IVR). We found that it is feasible to implement these proactive outreach interventions to promote the initiation of ASQ cessation treatment among Vietnamese-language speaking PWS. Future large trials are needed to rigorously compare PRO-MI and PRO-IVR and conduct budget impact analyses to understand the most efficient strategies for incorporation into health system settings.

Systematic surveillance of patient-reported symptoms of viral respiratory tract infectious Syndromes in diverse populations.

BACKGROUND: Patient reported outcome measures (PROM) can improve patient care and be crucial for symptom tracking especially during disease outbreaks. FLU-PRO Plus is a validated PROM used to track viral respiratory symptoms. Our study aimed to evaluate the feasibility of using FLU-PRO© Plus, to track symptoms across three healthcare systems. METHODS: The prospective, longitudinal study recruited adults between February-May 2021 from HealthPartners Institute (HP), Kaiser Permanente Georgia (KPGA), and Kaiser Permanente Mid-Atlantic States (KPMAS). Adult members were eligible if they had a positive lab or diagnosis for either COVID-19 or influenza-like illness (ILI) or exhibited 2 + viral respiratory symptoms. Descriptive statistics were calculated to describe the patient characteristics for participants that were eligible for FLU-PRO Plus, successfully contacted, attempted to log in to the FLU-PRO Plus website, and participants who completed FLU-PRO Plus Day 1. Bivariable and multivariable logistic regression using PROC GLIMMIXX investigated the patient characteristics associated with (1) successful contact and (2) FLU-PRO Plus Day 1 completion. RESULTS: We identified a total of 15,650 eligible participants during the enrollment period: 9,582 from HP, 1,740 from KPGA, and 4,328 from KPMAS. Among the total of 409 eligible adults who attempted to participate in FLU-PRO Plus, 317 completed FLU-PRO Plus Day 1. Among the 317 individuals that completed FLU-PRO Plus Day 1, 205 (67.5%) were diagnosed with COVID-19; 112 adults diagnosed with COVID-19 completed FLU-PRO Plus Day 14. Among adults successfully contacted, adults aged 35-64 (OR = 1.40, 95% CI 1.05, 1.87), females (OR = 1.77, 95% CI 1.38, 2.27), and adults diagnosed with COVID-19 (OR = 1.66, 95% CI 1.27, 2.17) had higher odds of completing FLU-PRO Plus Day 1; Asian adults (OR = 0.38, 95% CI 0.19, 0.76) and Black and African American adults (OR = 0.33, 95% CI 0.19, 0.76) had lower odds compared to White adults. CONCLUSION: Our study reports on the feasibility of patients across three integrated healthcare systems utilizing FLU-PRO Plus to monitor their respiratory symptoms. Patient reported outcome measures (PROM) can improve patient care, quality of life, and reduce the strain of limited resources on healthcare systems. Future FLU-PRO Plus studies should develop an implementation strategy to fully integrate FLU-PRO Plus within clinical care and patient management.

Complementary, Integrative, and Nondrug Therapy Use for Pain Among US Military Veterans on Long-term Opioids.

BACKGROUND: Long-term opioid therapy for chronic pain arose amid limited availability and awareness of other pain therapies. Although many complementary and integrative health (CIH) and nondrug therapies are effective for chronic pain, little is known about CIH/nondrug therapy use patterns among people prescribed opioid analgesics. OBJECTIVE: The objective of this study was to estimate patterns and predictors of self-reported CIH/nondrug therapy use for chronic pain within a representative national sample of US military veterans prescribed long-term opioids for chronic pain. RESEARCH DESIGN: National two-stage stratified random sample survey combined with electronic medical record data. Data were analyzed using logistic regressions and latent class analysis. SUBJECTS: US military veterans in Veterans Affairs (VA) primary care who received ≥6 months of opioid analgesics. MEASURES: Self-reported use of each of 10 CIH/nondrug therapies to treat or cope with chronic pain in the past year: meditation/mindfulness, relaxation, psychotherapy, yoga, t'ai chi, aerobic exercise, stretching/strengthening, acupuncture, chiropractic, massage; Brief Pain Inventory-Interference (BPI-I) scale as a measure of pain-related function. RESULTS: In total, 8891 (65%) of 13,660 invitees completed the questionnaire. Eighty percent of veterans reported past-year use of at least 1 nondrug therapy for pain. Younger age and female sex were associated with the use of most nondrug therapies. Higher pain interference was associated with lower use of exercise/movement therapies. Nondrug therapy use patterns reflected functional categories (psychological/behavioral, exercise/movement, manual). CONCLUSIONS: Use of CIH/nondrug therapies for pain was common among patients receiving long-term opioids. Future analyses will examine nondrug therapy use in relation to pain and quality of life outcomes over time.

Evidence Review-Social Determinants of Health for Veterans.

BACKGROUND: Veterans Health Administration (VHA) is committed to providing high-quality care and addressing health disparities for vulnerable Veterans. To meet these goals, VA policymakers need guidance on how to address social determinants in operations planning and day-to-day clinical care for Veterans. METHOD: MEDLINE (OVID), CINAHL, PsycINFO, and Sociological Abstracts were searched from inception to January 2017. Additional articles were suggested by peer reviewers and/or found through search of work associated with US and VA cohorts. Eligible articles compared Veterans vs non-Veterans, and/or Veterans engaged with those not engaged in VA healthcare. Our evidence maps summarized study characteristics, social determinant(s) addressed, and whether health behaviors, health services utilization, and/or health outcomes were examined. Qualitative syntheses and quality assessment were performed for articles on rurality, trauma exposure, and sexual orientation. RESULTS: We screened 7242 citations and found 131 eligible articles-99 compared Veterans vs non-Veterans, and 40 included engaged vs non-engaged Veterans. Most articles were cross-sectional and addressed socioeconomic factors (e.g., education and income). Fewer articles addressed rurality (N = 20), trauma exposure (N = 17), or sexual orientation (N = 2); none examined gender identity. We found no differences in rural residence between Veterans and non-Veterans, nor between engaged and non-engaged Veterans (moderate strength evidence). There was insufficient evidence for role of rurality in health behaviors, health services utilization, or health outcomes. Trauma exposures, including from events preceding military service, were more prevalent for Veterans vs non-Veterans and for engaged vs non-engaged Veterans (low-strength evidence); exposures were associated with smoking (low-strength evidence). DISCUSSION: Little published literature exists on some emerging social determinants. We found no differences in rural residence between our groups of interest, but trauma exposure was higher in Veterans (vs non-Veterans) and engaged (vs non-engaged). We recommend consistent measures for social determinants, clear conceptual frameworks, and analytic strategies that account for the complex relationships between social determinants and health.

Healthy for life: a randomized trial examining physical activity outcomes and psychosocial mediators.

BACKGROUND: Researchers theorize that interventions increase physical activity by influencing key theory-based mediators (e.g., behavioral processes). However, few studies have been adequately powered to examine the importance of mediators. PURPOSE: This study examined both physical activity behavior and psychosocial mediators in a randomized trial specifically powered to detect mediation. METHODS: Healthy, sedentary adults (n = 448; 70 % Caucasian, 87 % women, mean age was 43) were randomly assigned to either a 6-month print-based theory tailored physical activity intervention (n = 224) or a 6-month health/wellness contact control arm (n = 224). RESULTS: The print intervention arm exhibited greater increases in physical activity than the control arm at 6 and 12 months (p < .05). Additionally, behavioral processes were found to be an important mediator of physical activity behavior. CONCLUSIONS: It is important for researchers and practitioners to focus on increasing behavioral strategies for physical activity adoption. Future studies should examine other potential mediators of physical activity.

Enhancing long-term weight loss maintenance: 2 year results from the Keep It Off randomized controlled trial.

OBJECTIVE: The Keep It Off trial evaluated the efficacy of a phone-based weight loss maintenance intervention among adults who had recently lost weight in Minnesota (2007-2010). METHODS: 419 adults who had recently lost ≥ 10% of their body weight were randomized to the "Guided" or "Self-Directed" intervention. Guided participants received a 10 session workbook, 10 biweekly, eight monthly and six bimonthly phone coaching calls, bimonthly weight graphs and tailored letters based on self-reported weights. Self-Directed participants received the workbook and two calls. Primary outcomes are weight change and maintenance (regain of <2.5% of baseline body weight). RESULTS: Mixed model repeated-measures analysis examining weight change revealed a significant time by treatment group interaction (p<0.0085). Guided participants regained significantly less weight than the Self-Directed participants at 12 and 24 months. The odds of 24 month maintenance were 1.37 (95% CI: 0.97-2.03) times greater in the Guided than in the Self-Directed group. When maintenance rates were compared across all follow-ups, there was a consistently higher maintenance rate for Guided participants (HR 1.31, 95% CI: 1.12-1.54). CONCLUSIONS: A sustained, supportive phone- and mail-based intervention promotes weight loss maintenance relative to a brief intervention for participants who have recently lost weight.

Relationships between the Survey of Organizational Research Climate (SORC) and self-reported research practices.

The Survey of Organizational Research Climate (SORC) is a validated tool to facilitate promotion of research integrity and research best practices. This work uses the SORC to assess shared and individual perceptions of the research climate in universities and academic departments and relate these perceptions to desirable and undesirable research practices. An anonymous web- and mail-based survey was administered to randomly selected biomedical and social science faculty and postdoctoral fellows in the United States. Respondents reported their perceptions of the research climates at their universities and primary departments, and the frequency with which they engaged in desirable and undesirable research practices. More positive individual perceptions of the research climate in one's university or department were associated with higher likelihoods of desirable, and lower likelihoods of undesirable, research practices. Shared perceptions of the research climate tended to be similarly predictive of both desirable and undesirable research practices as individuals' deviations from these shared perceptions. Study results supported the central prediction that more positive SORC-measured perceptions of the research climate were associated with more positive reports of research practices. There were differences with respect to whether shared or individual climate perceptions were related to desirable or undesirable practices but the general pattern of results provide empirical evidence that the SORC is predictive of self-reported research behavior.

Development and validation of the Survey of Organizational Research Climate (SORC).

Development and targeting efforts by academic organizations to effectively promote research integrity can be enhanced if they are able to collect reliable data to benchmark baseline conditions, to assess areas needing improvement, and to subsequently assess the impact of specific initiatives. To date, no standardized and validated tool has existed to serve this need. A web- and mail-based survey was administered in the second half of 2009 to 2,837 randomly selected biomedical and social science faculty and postdoctoral fellows at 40 academic health centers in top-tier research universities in the United States. Measures included the Survey of Organizational Research Climate (SORC) as well as measures of perceptions of organizational justice. Exploratory and confirmatory factor analyses yielded seven subscales of organizational research climate, all of which demonstrated acceptable internal consistency (Cronbach's α ranging from 0.81 to 0.87) and adequate test-retest reliability (Pearson r ranging from 0.72 to 0.83). A broad range of correlations between the seven subscales and five measures of organizational justice (unadjusted regression coefficients ranging from 0.13 to 0.95) document both construct and discriminant validity of the instrument. The SORC demonstrates good internal (alpha) and external reliability (test-retest) as well as both construct and discriminant validity.

A UVR-sensor wearable device intervention to reduce sun exposure in melanoma survivors: Results from a randomized controlled trial.

BACKGROUND: Melanoma survivors are at increased risk of developing a second primary melanoma; however, some report sub-optimal sun behaviors and sunburns. We tested the effectiveness of a wearable device with ultraviolet radiation (UVR)-sensing technology to improve sun behaviors and reduce sunburns in cutaneous melanoma survivors. MATERIALS AND METHODS: We conducted a randomized controlled trial using Shade 2, a commercially available wrist device that measures UVR. The intervention group received the device and mobile application notifications about their exposure and prompts to use sunscreen. The control group received the device and a separate research mobile application without information about their exposure or notifications. Participants wore the device for 12 weeks and self-reported sun behaviors before, during, and after the intervention. The primary outcome was a composite score of sun protection behaviors at week 12. RESULTS: 386 participants were randomized (186 control, 182 intervention). Most were female and 5+ years past their first melanoma diagnosis. The average age was 56 years. Most (93%) completed the study, though 40% experienced device issues. No meaningful differences were observed in self-reported sun protection behaviors at week 12 (controls 3.0±0.5 vs. intervention 2.9±0.5, p = 0.06), any sunburn during the intervention period (controls 14.4% vs. intervention 12.7%, p = 0.75), or average daily objective UVR exposure (controls median 87 vs. intervention 83 J/m2, p = 0.43). CONCLUSION: Wearing a device that measured and alerted melanoma survivors to UVR exposure did not result in different sun behaviors, exposure, or sunburns relative to controls. The technology needs refinement before further attempts to assess the effectiveness of self-monitoring UVR exposure. CLINICAL TRIALS REGISTRATION: NCT03927742.

Obesogenic family types identified through latent profile analysis.

BACKGROUND: Obesity may cluster in families due to shared physical and social environments. PURPOSE: This study aims to identify family typologies of obesity risk based on family environments. METHODS: Using 2007-2008 data from 706 parent/youth dyads in Minnesota, we applied latent profile analysis and general linear models to evaluate associations between family typologies and body mass index (BMI) of youth and parents. RESULTS: Three typologies described most families with 18.8% "Unenriched/Obesogenic," 16.9% "Risky Consumer," and 64.3% "Healthy Consumer/Salutogenic." After adjustment for demographic and socioeconomic factors, parent BMI and youth BMI Z-scores were higher in unenriched/obesogenic families (BMI difference = 2.7, p < 0.01 and BMI Z-score difference = 0.51, p < 0.01, respectively) relative to the healthy consumer/salutogenic typology. In contrast, parent BMI and youth BMI Z-scores were similar in the risky consumer families relative to those in healthy consumer/salutogenic type. CONCLUSIONS: We can identify family types differing in obesity risks with implications for public health interventions.

Prevalence of Cardiovascular Disease and Risk Factors Among Somali Immigrants and Refugees.

BACKGROUND: Cardiovascular disease (CVD) risks are of concern among immigrants and refugees settling in affluent host countries. The prevalence of CVD and risk factors among Somali African immigrants to the U.S. has not been systematically studied. METHODS: In 2015-2016, we surveyed 1156 adult Somalis in a Midwestern metropolitan area using respondent-driven sampling to obtain anthropometric, interview, and laboratory data about CVD and associated risk factors, demographics, and social factors. RESULTS: The prevalence of diabetes and low physical activity among men and women was high. Overweight, obesity, and dyslipidemia were also particularly prevalent. Levels of calculated CVD risk across the community were greater for men than women. CONCLUSION: Though CVD risk is lower among Somalis than the general U.S. population, our results suggest significant prevalence of risk factors among Somali immigrants. Comparison with prior research suggests that CVD risks may be increasing, necessitating thoughtful intervention to prevent adverse population outcomes.

Maintaining physical activity among older adults: 24-month outcomes of the Keep Active Minnesota randomized controlled trial.

OBJECTIVE: To evaluate the efficacy at 6-, 12-, and 24-month follow-up of Keep Active Minnesota (KAM), a telephone and mail-based intervention designed to promote physical activity (PA) maintenance among currently active adults age 50 to 70. METHOD: Participants who reported having recently increased their MVPA to a minimum of 2d/wk, 30 min/bout, (N=1049) were recruited in 2004 and 2005 from one large managed care organization in Minnesota, and randomly assigned to either treatment (KAM; N=523), or Usual Care (UC; N=526) with PA assessed using the CHAMPS questionnaire, and expressed as kcal/wk energy expenditure. RESULTS: We find a sustained, significant benefit of the intervention at 6, 12 and 24 months. kcal/wk expenditure in moderate or vigorous activities was higher at 6 (p<.03, Cohen's d(6m)=.16), 12 (p<.04, d(12 m)=.13) and 24 months (p<.01, d(24 m)=.16) for KAM participants, compared to UC participants. CONCLUSIONS: The KAM telephone- and mail-based PA maintenance intervention was effective at maintaining PA in both the short-term (6 months) and longer-term (12 and 24 months) relative to usual care.

UVR-sensor wearable device intervention to improve sun behaviors and reduce sunburns in melanoma survivors: study protocol of a parallel-group randomized controlled trial.

BACKGROUND: Individuals who have been diagnosed with melanoma have more than a 9-fold increased risk of developing another melanoma. Ultraviolet radiation (UVR) exposure following a melanoma diagnosis can be modified to reduce risk of a new melanoma diagnosis. Yet research shows that many melanoma survivors do not report optimal sun protection practices. The objective of this study is to evaluate the effectiveness of a UVR-sensor wearable device to improve sun protection behaviors and reduce sunburns in a randomized controlled trial (RCT) in melanoma survivors. METHODS: We will conduct an RCT among 368 melanoma survivors in two waves (Summer 2020, Summer 2021). This approach allows for adequate recruitment of the required sample and potential improvements to recruitment, compliance, and retention strategies between waves. The intervention includes an informational brochure about sun protection behaviors and a commercially available UVR-sensor wearable device (Shade), which accurately measures UVR. The device, along with its associated mobile application, measures and stores UVR exposure. As UVR exposure accumulates, the device provides notifications to increase sun protection action. Survivors in the control group receive the device and a separate mobile application that does not provide notifications or summary UVR exposure data. Participants will be asked to wear the device for 12 weeks. They will complete surveys about their sun behaviors at study entry, every 4 weeks during the intervention, and 1 year later. At the end of the intervention period, intervention and control groups will be compared for differences in a summary measure of sun protection habits and experience of a sunburn. We will also measure self-reported physical activity, depression, and anxiety to examine potential unintended negative consequences of the intervention. DISCUSSION: The study intervention will be completed Fall 2021, with anticipated results available in 2022. If this intervention improves sun protection behaviors in melanoma survivors, these findings would support expanding the use of this technology with other populations at high risk for melanoma. TRIAL REGISTRATION: ClinicalTrials.gov NCT03927742 . Registered on April 15, 2019.

The evaluating prescription opioid changes in veterans (EPOCH) study: Design, survey response, and baseline characteristics.

In the United States (US), long-term opioid therapy has been commonly prescribed for chronic pain. Since recognition of the opioid overdose epidemic, clinical practice guidelines have recommended tapering long-term opioids to reduced doses or discontinuation. The Effects of Prescription Opioid Changes for veterans (EPOCH) study is a national population-based prospective observational study of US Veterans Health Administration primary care patients designed to assess effects of evolving opioid prescribing practice on patients treated with long-term opioids for chronic pain. A stratified random sampling design was used to identify a survey sample from the target population of patients treated with opioid analgesics for ≥ 6 months. Demographic, diagnostic, visit, and pharmacy dispensing data were extracted from existing datasets. A 2016 mixed-mode mail and telephone survey collected patient-reported data, including the main patient-reported outcomes of pain-related function (Brief Pain Inventory interference; BPI-I scores 0-10, higher scores = worse) and health-related quality of life. Data on survey participants and non-participants were analyzed to assess potential nonresponse bias. Weights were used to account for design. Linear regression models were used to assess cross-sectional associations of opioid treatment with patient-reported measures. Of 14,160 patients contacted, 9253 (65.4%) completed the survey. Participants were older than non-participants (63.9 ± 10.6 vs. 59.6 ± 13.0 years). The mean number of bothersome pain locations was 6.8 (SE 0.04). Effectiveness of pain treatment and quality of pain care were rated fair or poor by 56.1% and 45.3%, respectively. The opioid daily dosage range was 1.6 to 1038.2 mg, with mean = 50.6 mg (SE 1.1) and median = 30.9 mg (IQR 40.7). Among the 73.2% of patients who did not receive long-acting opioids, the mean daily dosage was 30.4 mg (SE 0.6) and mean BPI-I was 6.4 (SE 00.4). Among patients who received long-acting opioids, the mean daily dosage was 106.2 mg (SE 2.8) and mean BPI-I was 6.8 (SE 0.07). Higher daily dosage was associated with worse pain-related function and quality of life among patients without long-acting opioids, but not among patients with long-acting opioids. Future analyses will use follow-up data to examine effects of opioid dose reduction and discontinuation on patient outcomes.