Model of Care for Chronic Brain Injury.

There is growing evidence that long-term outcomes after traumatic brain injury (TBI) are more dynamic than stable. People continue to change, both improving and declining, many years postinjury. Research, practice, and medical education have not yet fully embraced the implications of TBI as a chronic, dynamic condition. In 2020, the National Institute on Disability Independent Living and Rehabilitation Research funded the BeHEALTHY project to develop a model for long-term support of persons with chronic brain injury. Based on initial reviews of the available evidence and expert input from researchers, clinicians, and persons with lived experience, the BeHEALTHY model was proposed. Among existing chronic disease treatment models, Wagner's Chronic Care Model was selected as a starting point, with several critical refinements. The BeHEALTHY model endorses a person-centered approach, recognizing the individual with brain injury, and their social support system, as the primary source of goals in care planning. The model also acknowledges the critical importance of self-management and the need for health care programs to actively promote self-direction by the person using their social supports. The model also recognizes that outcomes are not determined solely by the person and the injury incurred but also by the environment in which a person lives and recovers. The importance of integrating health care with community resources is underscored by embracing environmental influences as a shared responsibility of the community and the health care system. This article recounts the impetus for developing the BeHEALTHY model and describes those it is intended to serve and its structural features and core components.

An Umbrella Review of Self-Management Interventions for Health Conditions With Symptom Overlap With Traumatic Brain Injury.

OBJECTIVE: To synthesize evidence for the effectiveness of self-management interventions for chronic health conditions that have symptom overlap with traumatic brain injury (TBI) in order to extract recommendations for self-management intervention in persons with TBI. DESIGN: An umbrella review of existing systematic reviews and/or meta-analyses of randomized controlled trials or nonrandomized studies targeting self-management of chronic conditions and specific outcomes relevant to persons with TBI. METHOD: A comprehensive literature search of 5 databases was conducted using PRISMA guidelines. Two independent reviewers conducted screening and data extraction using the Covidence web-based review platform. Quality assessment was conducted using criteria adapted from the Assessing the Methodological Quality of Systematic Reviews-2 (AMSTAR-2). RESULTS: A total of 26 reviews met the inclusion criteria, covering a range of chronic conditions and a range of outcomes. Seven reviews were of moderate or high quality and focused on self-management in persons with stroke, chronic pain, and psychiatric disorders with psychotic features. Self-management interventions were found to have positive effects on quality of life, self-efficacy, hope, reduction of disability, pain, relapse and rehospitalization rates, psychiatric symptoms, and occupational and social functioning. CONCLUSIONS: Findings are encouraging with regard to the effectiveness of self-management interventions in patients with symptoms similar to those of TBI. However, reviews did not address adaptation of self-management interventions for those with cognitive deficits or for populations with greater vulnerabilities, such as low education and older adults. Adaptations for TBI and its intersection with these special groups may be needed.

Progress Toward Meaning-as-Goal and Its Association with Pain, Functioning, and Global Meaning and Purpose Among Veterans with Co-occurring Chronic Pain and PTSD.

BACKGROUND: Co-occurring chronic pain and posttraumatic stress disorder (PTSD) is associated with poorer physical and mental functioning and well-being. Treatments often incorporate goal-setting around personally meaningful behaviors; however, it is unclear whether intentionally focusing on improving meaning and purpose in life (i.e., meaning-as-goal) may also serve as a helpful treatment target. The objective of the current study is to determine whether reported progress toward meaning-as-goal at 6 months is associated with pain severity and interference, physical and mental health functioning, and global meaning and purpose at 6- and 12-months. METHODS: Data were collected as part of an evaluation effort focused on VA's Whole Health System implementation efforts. VA electronic health records were linked to survey data across three time points (baseline, 6 months, and 12 months) from Veterans with both chronic pain and PTSD across 18 VA sites. A total of 1341 Veterans met inclusion criteria (mean age = 62, SD = 11.7). RESULTS: Regression analyses showed that progress toward meaning-as-goal was significantly associated with all 6-month variables, with standardized coefficients ranging from - 0.14 (pain severity and interference) to .37 (global meaning and purpose), in addition to all 12-month variables, with standardized coefficients ranging from - .13 (pain severity and interference) to .31 (global meaning and purpose). CONCLUSIONS: Efforts to intentionally promote meaning and purpose as part of evidence-based treatment for chronic pain and PTSD may lead to decreased pain and improved physical and mental health functioning and global meaning and purpose. With coefficients ranging from small to moderate effect sizes, more work is needed to better understand how best to maximize meaning-related goals.

Anomalies in the review process and interpretation of the evidence in the NICE guideline for chronic fatigue syndrome and myalgic encephalomyelitis.

Chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME) is a disabling long-term condition of unknown cause. The National Institute for Health and Care Excellence (NICE) published a guideline in 2021 that highlighted the seriousness of the condition, but also recommended that graded exercise therapy (GET) should not be used and cognitive-behavioural therapy should only be used to manage symptoms and reduce distress, not to aid recovery. This U-turn in recommendations from the previous 2007 guideline is controversial.We suggest that the controversy stems from anomalies in both processing and interpretation of the evidence by the NICE committee. The committee: (1) created a new definition of CFS/ME, which 'downgraded' the certainty of trial evidence; (2) omitted data from standard trial end points used to assess efficacy; (3) discounted trial data when assessing treatment harm in favour of lower quality surveys and qualitative studies; (4) minimised the importance of fatigue as an outcome; (5) did not use accepted practices to synthesise trial evidence adequately using GRADE (Grading of Recommendations, Assessment, Development and Evaluations trial evidence); (6) interpreted GET as mandating fixed increments of change when trials defined it as collaborative, negotiated and symptom dependent; (7) deviated from NICE recommendations of rehabilitation for related conditions, such as chronic primary pain and (8) recommended an energy management approach in the absence of supportive research evidence.We conclude that the dissonance between this and the previous guideline was the result of deviating from usual scientific standards of the NICE process. The consequences of this are that patients may be denied helpful treatments and therefore risk persistent ill health and disability.

Recent tapering from long-term opioid therapy and odds of opioid-related hospital use.

PURPOSE: The number of patients tapered from long-term opioid therapy (LTOT) has increased in recent years in the United States. Some patients tapered from LTOT report improved quality of life, while others face increased risks of opioid-related hospital use. Research has not yet established how the risk of opioid-related hospital use changes across LTOT dose and subsequent tapering. Our objective was to examine associations between recent tapering from LTOT with odds of opioid-related hospital use. METHODS: Case-crossover design using 2014-2018 health information exchange data from Indiana. We defined opioid-related hospital use as hospitalizations, and emergency department (ED) visits for a drug overdose, opioid abuse, and dependence. We defined tapering as a 15% or greater dose reduction following at least 3 months of continuous opioid therapy of 50 morphine milligram equivalents (MME)/day or more. We used conditional logistic regression to estimate odds ratios (OR) with 95% confidence intervals (CI). RESULTS: Recent tapering from LTOT was associated with increased odds of opioid-related hospital use (OR: 1.50, 95%CI: 1.34-1.63), ED visit (OR: 1.52; 95%CI: 1.35-1.72), and inpatient hospitalization (OR: 1.40; 95%CI: 1.20-1.65). We found no evidence of heterogeneity of the effect of tapering on opioid-related hospital use by gender, age, and race. Recent tapering among patients on a high baseline dose (>300 MME) was associated with increased odds of opioid-related hospital use (OR: 2.95, 95% CI: 2.12-4.11, p < 0.001) compared to patients on a lower baseline doses. CONCLUSIONS: Recent tapering from LTOT is associated with increased odds of opioid-related hospital use.

A Review of the Evidence and Recommendations on Communication Skills and the Patient-Provider Relationship: A Rome Foundation Working Team Report.

BACKGROUND & AIMS: Over several decades, changes in health care have negatively impacted meaningful communication between the patient and provider and adversely affected their relationship. Under increasing time pressure, physicians rely more on technology than face-to-face time gathering data to make clinical decisions. As a result, they find it more challenging to understand the illness context and fully address patient needs. Patients experience dissatisfaction and a diminution of their role in the care process. For patients with disorders of gut-brain interaction, stigma leads to greater care dissatisfaction, as there is no apparent structural basis to legitimize the symptoms. Recent evidence suggests that practical communication skills can improve the patient-provider relationship (PPR) and clinical outcomes, but these data are limited. METHODS: The Rome Foundation convened a multidisciplinary working team to review the scientific evidence with the following aims: a) to study the effect of communication skills on patient satisfaction and outcomes by performing an evidence-based review; b) to characterize the influence of sociocultural factors, health care system constraints, patient perspective, and telehealth on the PPR; c) to review the measurement and impact of communication skills training on these outcomes; and d) to make recommendations to improve communication skills training and the PPR. RESULTS: Evidence supports the fact that interventions targeting patient-provider interactions improve population health, patient and provider experience, and costs. Communication skills training leads to improved patient satisfaction and outcomes. The following are relevant factors to consider in establishing an effective PPR: addressing health care system constraints; incorporating sociocultural factors and the role of gender, age, and chronic illness; and considering the changing role of telehealth on the PPR. CONCLUSIONS: We concluded that effective communication skills can improve the PPR and health outcomes. This is an achievable goal through training and system change. More research is needed to confirm these findings.

The Patient Mania Questionnaire (PMQ-9): a Brief Scale for Assessing and Monitoring Manic Symptoms.

BACKGROUND: Measurement-based care is an effective clinical strategy underutilized for bipolar disorder partly due to lacking a widely adopted patient-reported manic symptom measure. OBJECTIVE: To report development and psychometric properties of a brief patient-reported manic symptom measure. DESIGN: Secondary analysis of data collected in a randomized effectiveness trial comparing two treatments for 1004 primary care patients screening positive for bipolar disorder and/or PTSD. PARTICIPANTS: Two analytic samples included 114 participants with varied diagnoses and test-retest data, and 179 participants with psychiatrist-diagnosed bipolar disorder who had two or more assessments with the nine-item Patient Mania Questionnaire-9 [PMQ-9]). MAIN MEASURES: Internal and test-retest reliability, concurrent validity, and sensitivity to change were assessed. Minimally important difference (MID) was estimated by standard error of measurement (SEM) and by standard deviation (SD) effect sizes. KEY RESULTS: The PMQ-9 had high internal reliability (Cronbach's alpha = 0.88) and test-retest reliability (0.85). Concurrent validity correlation with manic symptom measures was high for the Internal State Scale-Activation Subscale (0.70; p<0.0001), and lower for the Altman Mania Rating Scale (0.26; p=0.007). Longitudinally, PMQ-9 was completed at 1511 clinical encounters in 179 patients with bipolar disorder. Mean PMQ-9 score at first and last encounters was 14.5 (SD 6.5) and 10.1 (SD 7.0), a 27% decrease in mean score during treatment, suggesting sensitivity to change. A point estimate of the MID was approximately 3 points (range of 2-4). CONCLUSIONS: The PMQ-9 demonstrated excellent test-retest reliability, concurrent validity, internal consistency, and sensitivity to change and was widely used and acceptable to patients and clinicians in a pragmatic clinical trial. Combined with the Patient Health Questionnaire-9 (PHQ-9) measure of depressive symptoms this brief measure could inform measurement-based care for individuals with bipolar disorder in primary care and mental health care settings given its ease of administration and familiar self-report response format.

Acceptance and commitment therapy for patient fatigue interference and caregiver burden in advanced gastrointestinal cancer: Results of a pilot randomized trial.

BACKGROUND: Fatigue often interferes with functioning in patients with advanced cancer, resulting in increased family caregiver burden. Acceptance and commitment therapy, a promising intervention for cancer-related suffering, has rarely been applied to dyads coping with advanced cancer. AIM: To examine the feasibility, acceptability, and preliminary efficacy of acceptance and commitment therapy for patient-caregiver dyads coping with advanced gastrointestinal cancer. Primary outcomes were patient fatigue interference and caregiver burden. DESIGN: In this pilot trial, dyads were randomized to six weekly sessions of telephone-delivered acceptance and commitment therapy or education/support, an attention control. Outcomes were assessed at baseline and at 2 weeks and 3 months post-intervention. SETTING/PARTICIPANTS: Forty patients with stage III-IV gastrointestinal cancer and fatigue interference and family caregivers with burden or distress were recruited from two oncology clinics and randomized. RESULTS: The eligibility screening rate (54%) and retention rate (81% at 2 weeks post-intervention) demonstrated feasibility. At 2 weeks post-intervention, acceptance and commitment therapy participants reported high intervention helpfulness (mean = 4.25/5.00). Group differences in outcomes were not statistically significant. However, when examining within-group change, acceptance and commitment therapy patients showed moderate decline in fatigue interference at both follow-ups, whereas education/support patients did not show improvement at either follow-up. Acceptance and commitment therapy caregivers showed medium decline in burden at 2 weeks that was not sustained at 3 months, whereas education/support caregivers showed little change in burden. CONCLUSIONS: Acceptance and commitment therapy showed strong feasibility, acceptability, and promise and warrants further testing. TRIAL REGISTRATION: ClinicalTrials.gov NCT04010227. Registered 8 July 2019, https://clinicaltrials.gov/ct2/show/NCT04010227?term=catherine+mosher&draw=2&rank=1.

Choosing and Using Patient-Reported Outcome Measures in Clinical Practice.

The increasing use of patient-reported outcome (PRO) measures is forcing clinicians and health care systems to decide which to select and how to incorporate them into their records and clinical workflows. This overview addresses 3 topics related to these concerns. First, a literature review summarizes key psychometric and practical factors (such as reliability, responsiveness, computer adaptive testing, and interpretability) in choosing PROs for clinical practice. Second, 3 clinical decision support issues are highlighted: gathering PROs, electronic health record effect on providers, and incorporating PROs into clinical decision support design and implementation. Lastly, the salience of crosscutting domains as well as 9 key pragmatic decisions are reviewed. Crosscutting domains are those that are relevant across most medical and mental health conditions, such as the SPADE symptom pentad (sleep problems, pain, anxiety, depression, low energy/fatigue) and physical functioning. The 9 pragmatic decisions include (1) generic vs disease-specific scales; (2) single- vs multidomain scales; (3) universal scales vs user-choice selection; (4) number of domains to measure; (5) prioritization of domains when multiple domains are assessed; (6) action thresholds; (7) clinical purpose (screening vs monitoring); as well as the (8) frequency and (9) logistical aspects of PRO administration.

SymTrak-8 as a Brief Measure for Assessing Symptoms in Older Adults.

BACKGROUND: Patient- and caregiver-reported 23-item SymTrak scales were validated for monitoring clinically actionable symptoms and impairments associated with multiple chronic conditions (MCCs) in older adults. Items capture physical and emotional symptoms and impairments in physical and cognitive functioning. An abbreviated SymTrak is desirable when response burden is a concern. OBJECTIVE: Develop and validate the 8-item SymTrak. DESIGN AND PARTICIPANTS: Secondary analysis of SymTrak validation study; 600 participants (200 patient-caregiver dyads; 200 patients without an identified caregiver). MAIN MEASURES: Demographic questions, SymTrak, and Health Utility Index Mark 3 (HUI3). KEY RESULTS: SymTrak-8 demonstrated good fit to a one-factor model using confirmatory factor analysis (CFA). Concurrent criterion validity was supported by high standardized linear regression coefficients (STB) between baseline SymTrak-8 total score (independent variable) and baseline HUI3 preference-based overall HRQOL utility score (dependent variable; 0 = death, 1 = perfect health), after adjusting for demographics, comorbid conditions, and medications, with strength comparable to SymTrak-23 (STB = - 0.81 and - 0.84, respectively, for SymTrak-8 and SymTrak-23, when patient-reported; and - 0.60 and - 0.62, respectively, when caregiver-reported). Coefficient alpha (0.74; 0.76) and 24-h test-retest reliability (0.83; 0.87) were high for SymTrak-8 for patients and caregivers, respectively. The convergent correlation between brief and parent SymTrak scales was high (0.94). SymTrak-8 demonstrated approximate normality and a linear relationship with SymTrak-23 and HUI3. Importantly, a 3-month change in SymTrak-8 was sensitive to detecting the criterion (3-month reliable change categories; improved, stable, declined in HUI3 overall utility), with results comparable to SymTrak-23. CONCLUSIONS: SymTrak-8 total score demonstrates internal reliably, test-retest reliability, criterion validity, and sensitivity to change that are comparable to SymTrak-23. Thus, patient- or caregiver-reported SymTrak-8 is a viable option for identifying and monitoring the aggregate effect of symptoms and functional impairments in patients with multimorbidity when response burden is a concern.

Responsiveness of PROMIS and Patient Health Questionnaire (PHQ) Depression Scales in three clinical trials.

BACKGROUND: The PROMIS depression scales are reliable and valid measures that have extensive normative data in general population samples. However, less is known about how responsive they are to detect change in clinical settings and how their responsiveness compares to legacy measures. The purpose of this study was to assess and compare the responsiveness of the PROMIS and Patient Health Questionnaire (PHQ) depression scales in three separate samples. METHODS: We used data from three clinical trials (two in patients with chronic pain and one in stroke survivors) totaling 651 participants. At both baseline and follow-up, participants completed four PROMIS depression fixed-length scales as well as legacy measures: Patient Health Questionnaire 9-item and 2-item scales (PHQ-9 and PHQ-2) and the SF-36 Mental Health scale. We measured global ratings of depression change, both prospectively and retrospectively, as anchors to classify patients as improved, unchanged, or worsened. Responsiveness was assessed with standardized response means, statistical tests comparing change groups, and area-under-curve analysis. RESULTS: The PROMIS depression and legacy scales had generally comparable responsiveness. Moreover, the four PROMIS depression scales of varying lengths were similarly responsive. In general, measures performed better in detecting depression improvement than depression worsening. For all measures, responsiveness varied based on the study sample and on whether depression improved or worsened. CONCLUSIONS: Both PROMIS and PHQ depression scales are brief public domain measures that are responsive (i.e., sensitive to change) and thus appropriate as outcome measures in research as well as for monitoring treatment in clinical practice. Trial registration ClinicalTrials.gov ID: NCT01236521, NCT01583985, NCT01507688.

Short-Term Psychodynamic Psychotherapy for Functional Somatic Disorders: A Meta-Analysis of Randomized Controlled Trials.

INTRODUCTION: Functionalsomatic disorders (FSD) are common and costly, thereby driving the need for the development of effective brief treatment options. Short-term psychodynamic psychotherapy (STPP) is one candidate treatment method. OBJECTIVE: To review and meta-analyze, where possible, randomized controlled trials (RCTs) of STPP for FSD. METHODS: Following a systematic search of the literature, we performed a meta-analysis of available RCT groups to determine the effects of STPP on a range of outcomes after treatment, and medium- and long-term follow-ups. RESULTS: In meta-analyses of 17 RCTs, STPP significantly outperformed minimal treatment, treatment as usual, or waiting list controls on somatic symptom measures at all time frames, with small to large magnitude effect sizes. Descriptive reviews of 5 RCTs suggest that STPP performed at least as well as other bona fide psychological therapies. Limitations of this meta-analysis include small samples of studies and possible publication bias. CONCLUSIONS: STPP is a valid treatment option for diverse FSD conditions resulting in somatic symptom reductions that persist over time. STPP should be included in FSD treatment guidelines.

Patients' Experiences with Telecare for Chronic Pain and Mood Symptoms: A Qualitative Study.

OBJECTIVE: Pain, anxiety, and depression commonly co-occur, can have reciprocal effects, and are associated with substantial disability and health care costs. However, few interventions target treatment of pain and mood disorders as a whole. The Comprehensive vs. Assisted Management of Mood and Pain Symptoms (CAMMPS) trial was a randomized trial comparing two pragmatic telecare interventions, a high- vs low-resource approach to pain and anxiety/depression treatment. The purpose of the current study is to better understand patients' perspectives on both intervention approaches, including intervention components, delivery, patient experiences, and patient outcomes. DESIGN: Qualitative, semistructured interviews. SETTING: A Veterans Affairs Medical Center. SUBJECTS: Twenty-five patients were purposefully sampled from both study arms. METHODS: Patients were interviewed about their experiences with pain and mood treatment, perceived benefits and changes, and experiences with the intervention model to which they were randomized. The constant comparison method guided analysis. RESULTS: Pain was more important than mood for most participants. Participants described developing increased awareness of their symptoms, including connecting pain and mood, which enabled better management. Participants in the high-resource intervention described the added value of the study nurse in their symptom management. CONCLUSIONS: Patients in a telecare intervention for chronic pain and mood symptoms learned to connect pain and mood and be more aware of their symptoms, enabling more effective symptom management. Patients in the high-resource intervention described the added benefits of a nurse who provided informational and motivational support. Implications for tradeoffs between resource intensity and patient outcomes are discussed.

Sleep Disturbance Predicts Less Improvement in Pain Outcomes: Secondary Analysis of the SPACE Randomized Clinical Trial.

OBJECTIVE: Sleep disturbance may limit improvement in pain outcomes if not directly addressed in treatment. Moreover, sleep problems may be exacerbated by opioid therapy. This study examined the effects of baseline sleep disturbance on improvement in pain outcomes using data from the Strategies for Prescribing Analgesics Comparative Effectiveness (SPACE) trial, a pragmatic 12-month randomized trial of opioid vs nonopioid medication therapy. DESIGN: Participants with chronic back pain or hip or knee osteoarthritis pain were randomized to either opioid therapy (N = 120) or nonopioid medication therapy (N = 120). METHODS: We used mixed models for repeated measures to 1) test whether baseline sleep disturbance scores modified the effect of opioid vs nonopioid treatment on pain outcomes and 2) test baseline sleep disturbance scores as a predictor of less improvement in pain outcomes across both treatment groups. RESULTS: The tests for interaction of sleep disturbance by treatment group were not significant. Higher sleep disturbance scores at baseline predicted less improvement in Brief Pain Inventory (BPI) interference (ß = 0.058, P = 0.0002) and BPI severity (ß = 0.026, P = 0.0164). CONCLUSIONS: Baseline sleep disturbance adversely affects pain response to treatment regardless of analgesic regimen. Recognition and treatment of sleep impairments that frequently co-occur with pain may optimize outcomes.

Comparative Responsiveness and Minimally Important Difference of Common Anxiety Measures.

BACKGROUND: Anxiety is one of the most prevalent mental disorders and accounts for substantial disability as well as increased health care costs. This study examines the minimally important difference (MID) and responsiveness of 6 commonly used anxiety scales. METHODS: The sample comprised 294 patients from 6 primary care clinics in a single VA medical center who were enrolled in a telecare trial for treatment of chronic musculoskeletal pain and comorbid depression and/or anxiety. The measures assessed were the Patient Reported Outcomes Measurement Information System (PROMIS) 4-item, 6-item, and 8-item anxiety scales; the Generalized Anxiety Disorder 7-item scale (GAD-7); the Symptom Checklist anxiety subscale (SCL); the Posttraumatic Stress Disorder Checklist (PCL); the Short Form (SF)-36 Mental Health subscale; and the SF-12 Mental Component Summary (MCS). Validity was assessed with correlations of these measures with one another and with measures of quality of life and disability. MID was estimated by triangulating several methods. Responsiveness was evaluated by comparing: (a) the standardized response means for patients who reported their mood as being better, the same, or worse at 3 months; (b) the area under the curve for patients who had improved (better) versus those who had not (same/worse). RESULTS: Convergent and construct validity was supported by strong correlations of the anxiety measures with one another and moderate correlations with quality of life and disability measures, respectively. All measures differentiated patients who reported global improvement at 3 months from those who were unchanged, but were less able to distinguish worsening from no change. The area under the curves showed comparable responsiveness of the scales. The estimated MID was 4 for the PROMIS scales; 3 for the GAD-7; 6 for the PCL; 9 for the SF-36 mental health subscale; 5 for the MCS score, and 0.3 for the SCL anxiety scale. CONCLUSIONS: Six commonly used anxiety scales demonstrate similar responsiveness, and estimated MIDs can be used to gauge anxiety change in clinical research and practice.

Automated Self-management (ASM) vs. ASM-Enhanced Collaborative Care for Chronic Pain and Mood Symptoms: the CAMMPS Randomized Clinical Trial.

BACKGROUND: Chronic musculoskeletal pain is often accompanied by depression or anxiety wherein co-occurring pain and mood symptoms can be more difficult to treat than either alone. However, few clinical trials have examined interventions that simultaneously target both pain and mood conditions. OBJECTIVE: To determine the comparative effectiveness of automated self-management (ASM) vs. ASM-enhanced collaborative care. DESIGN: Randomized clinical trial conducted in six primary care clinics in a VA medical center. PARTICIPANTS: Two hundred ninety-four patients with chronic musculoskeletal pain of at least moderate intensity and clinically significant depressive and/or anxiety symptoms. INTERVENTION: ASM consisted of automated monitoring and 9 web-based self-management modules. Comprehensive symptom management (CSM) combined ASM with collaborative care management by a nurse-physician team. Both interventions were delivered for 12 months. MAIN MEASURES: Primary outcome was a composite pain-anxiety-depression (PAD) z-score consisting of the mean of the BPI, PHQ-9, and GAD-7 z-scores: 0.2, 0.5, and 0.8 represent potentially small, moderate, and large clinical differences. Secondary outcomes included global improvement, health-related quality of life, treatment satisfaction, and health services use. KEY RESULTS: Both CSM and ASM groups had moderate PAD score improvement at 12 months (z = - 0.65 and - 0.52, respectively). Compared to the ASM group, the CSM group had a - 0.23 (95% CI, - 0.38 to - 0.08; overall P = .003) greater decline in composite PAD z-score over 12 months. CSM patients were also more likely to report global improvement and less likely to report worsening at 6 (P = .004) and 12 months (P = .013). CONCLUSIONS: Two intervention models relying heavily on telecare delivery but differing in resource intensity both produced moderate improvements in pain and mood symptoms. However, the model combining collaborative care led by a nurse-physician team with web-based self-management was superior to self-management alone. TRIAL REGISTRATION: ClinicalTrials.gov : NCT0175730.

Development and Feasibility of SymTrak, aMulti-domain Tool for Monitoring Symptoms of Older Adults in Primary Care.

BACKGROUND: A clinically practical, brief, user-friendly, multi-domain self-report and caregiver-report tool is needed for tracking actionable symptoms in primary care for elderly patients with multiple chronic conditions (MCCs). OBJECTIVE: Develop and assess usability, administration time, and internal reliability of SymTrak. DESIGN AND PARTICIPANTS: Phase I: legacy instruments, content validity, analyses of existing data, focus groups (physicians, nurses, patients, informal caregivers), and Think Aloud interviews (patients, caregivers) were used to develop SymTrak. Phase II (pilot feasibility study): 81 (27 patient-caregiver dyads, 27 patients without an identified caregiver) participants were self-administered SymTrak in clinic. MAIN MEASURES: SymTrak and demographic questions. KEY RESULTS: Consistent themes emerged from phase I focus groups. Ambiguous wording was corrected with Think Aloud feedback. In phase II, patients and caregivers preferred circling words instead of numbers for item response options. SymTrak self-administration completion time in clinic was brief; mean was 2.4, 3.0, and 3.3 min for the finalized circlingwords version, respectively, for caregivers, dyadic patients, and patients without a caregiver; and the maximum was 6.2 min for any participant. Usability questionnaire ratings were high. Cronbach's alpha for the SymTrak 23-item total score was 0.86, 0.79, and 0.81 for caregivers, dyadic patients, and patients without a caregiver, respectively. CONCLUSIONS: SymTrak demonstrates content validity, positive qualitative findings, high perceived usability, brief self-administered completion time, and good internal reliability.

Reliability and Validity of SymTrak, a Multi-Domain Tool for Monitoring Symptoms of Older Adults with Multiple Chronic Conditions.

BACKGROUND: A reliable and valid clinically practical multi-domain self-report and caregiver-report tool is needed for tracking actionable symptoms in primary care for elderly patients with multiple chronic conditions (MCCs). OBJECTIVE: Assess internal consistency reliability, test-retest reliability, construct validity, and sensitivity to change for SymTrak. DESIGN AND PARTICIPANTS: Among 600 (200 patient-caregiver dyads, 200 patients without an identified caregiver) participants, SymTrak was telephone interviewer-administered at baseline and 3-month follow-up, and at 24 h post-baseline for assessing test-retest reliability in a random subsample of 180 (60 dyads, 60 individual patients) participants. MAIN MEASURES: Demographic questions, SymTrak, Health Utility Index Mark 3 (HUI3). KEY RESULTS: Exploratory factor analysis indicated a single dominant dimension for SymTrak items for both patients and caregivers. Coefficient alpha and 24-h test-retest reliability, respectively, were high for the 23-item SymTrak total score for both patient-reported (0.85; 0.87) and caregiver-reported (0.86; 0.91) scores. Construct validity was supported by monotone decreasing relationships between the mean of SymTrak total scores across the poor-to-excellent categories of physical and emotional general health, and by high correlations with HUI3 overall utility score, even after adjusting for demographic covariates (standardized linear regression coefficient = - 0.84 for patients; - 0.70 for caregivers). Three-month change in the SymTrak total score was sensitive to detecting criterion standard 3-month reliable change categories (Improved, Stable, Declined) in HUI3-based health-related quality of life, especially for caregiver-reported scores. CONCLUSIONS: SymTrak demonstrates good internal consistency and test-retest reliability, construct validity, and sensitivity to change over a 3-month period, supporting its use for monitoring symptoms for older adults with MCCs.

Measurement invariance of the patient health questionnaire-9 (PHQ-9) depression screener in U.S. adults across sex, race/ethnicity, and education level: NHANES 2005-2016.

BACKGROUND: Despite its popularity, little is known about the measurement invariance of the Patient Health Questionnaire-9 (PHQ-9) across U.S. sociodemographic groups. Use of a screener shown not to possess measurement invariance could result in under/over-detection of depression, potentially exacerbating sociodemographic disparities in depression. Therefore, we assessed the factor structure and measurement invariance of the PHQ-9 across major U.S. sociodemographic groups. METHODS: U.S. population representative data came from the 2005-2016 National Health and Nutrition Examination Survey (NHANES) cohorts. We conducted a measurement invariance analysis of 31,366 respondents across sociodemographic factors of sex, race/ethnicity, and education level. RESULTS: Considering results of single-group confirmatory factor analyses (CFAs), depression theory, and research utility, we justify a two-factor structure for the PHQ-9 consisting of a cognitive/affective factor and a somatic factor (RMSEA = 0.034, TLI = 0.985, CFI = 0.989). On the basis of multiple-group CFAs testing configural, scalar, and strict factorial invariance, we determined that invariance held for sex, race/ethnicity, and education level groups, as all models demonstrated close model fit (RMSEA = 0.025-0.025, TLI = 0.985-0.992, CFI = 0.986-0.991). Finally, for all steps ΔCFI was <-0.004, and ΔRMSEA was <0.01. CONCLUSIONS: We demonstrate that the PHQ-9 is acceptable to use in major U.S. sociodemographic groups and allows for meaningful comparisons in total, cognitive/affective, and somatic depressive symptoms across these groups, extending its use to the community. This knowledge is timely as medicine moves towards alternative payment models emphasizing high-quality and cost-efficient care, which will likely incentivize behavioral and population health efforts. We also provide a consistent, evidence-based approach for calculating PHQ-9 subscale scores.