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PURPOSE Cisplatin is widely used and highly ototoxic, but patient-reported functional impairment because of cisplatin-related hearing loss (HL) and tinnitus has not been comprehensively evaluated. PATIENTS AND METHODS Testicular cancer survivors (TCS) given first-line cisplatin-based chemotherapy completed validated questionnaires, including the Hearing Handicap Inventory for Adults (HHIA) and Tinnitus Primary Function Questionnaire (TPFQ), each of which quantifies toxicity-specific functional impairment. Spearman correlations evaluated associations between HL and tinnitus severity and level of functional handicap quantified with the HHIA and TPFQ, respectively. Associations between HL or tinnitus and five prespecified adverse health outcomes (cognitive dysfunction, fatigue, depression, anxiety, and overall health) were evaluated. RESULTS HL and tinnitus affected 137 (56.4%) and 147 (60.5%) of 243 TCS, respectively. Hearing aids were used by 10% TCS (14/137). Of TCS with HL, 35.8% reported clinically significant functional impairment. Severe HHIA-assessed functional impairment was associated with cognitive dysfunction (odds ratio [OR], 10.62; P < .001), fatigue (OR, 5.48; P = .003), and worse overall health (OR, 0.19; P = .012). Significant relationships existed between HL severity and HHIA score, and tinnitus severity and TPFQ score ( P < .0001 each). TCS with either greater hearing difficulty or more severe tinnitus were more likely to report cognitive dysfunction (OR, 5.52; P = .002; and OR, 2.56; P = .05), fatigue (OR, 6.18; P < .001; and OR, 4.04; P < .001), depression (OR, 3.93; P < .01; and OR, 3.83; P < .01), and lower overall health (OR, 0.39; P = .03; and OR, 0.46; P = .02, respectively). CONCLUSION One in three TCS with HL report clinically significant functional impairment. Follow-up of cisplatin-treated survivors should include routine assessment for HL and tinnitus. Use of the HHIA and TPFQ permit risk stratification and referral to audiologists as needed, since HL adversely affects functional status and is the single largest modifiable risk factor for cognitive decline and dementia in the general population.

Measurement-based care (MBC) is an evidence-based practice that is rarely integrated into psychotherapy. The authors sought to determine whether tailored MBC implementation can improve clinician fidelity and depression outcomes compared with standardized implementation.This cluster-randomized trial enrolled 12 community behavioral health clinics to receive 5 months of implementation support. Clinics randomized to the standardized implementation received electronic health record data captured with the nine-item Patient Health Questionnaire (PHQ-9), a needs assessment, clinical training, guidelines, and group consultation in MBC fidelity. Tailored implementation support included these strategies, but the training content was tailored to clinics’ barriers to MBC, and group consultation centered on overcoming these barriers. Clinicians (N=83, tailored; N=71, standardized) delivering individual psychotherapy to 4,025 adults participated. Adult patients (N=87, tailored; N=141, standardized) contributed data for depression outcome analyses.The odds of PHQ-9 completion were lower in the tailored group at baseline (odds ratio [OR]=0.28, 95% CI=0.08–0.96) but greater at 5 months (OR=3.39, 95% CI=1.00–11.48). The two implementation groups did not differ in full MBC fidelity. PHQ-9 scores decreased significantly from baseline (mean±SD=17.6±4.4) to 12 weeks (mean=12.6±5.9) (p0.001), but neither implementation group nor MBC fidelity significantly predicted PHQ-9 scores at week 12.Tailored MBC implementation outperformed standardized implementation with respect to PHQ-9 completion, but discussion of PHQ-9 scores in clinician-patient sessions remained suboptimal. MBC fidelity did not predict week-12 depression severity. MBC can critically inform collaborative adjustments to session or treatment plans, but more strategic system-level implementation support or longer implementation periods may be needed.

Bipolar disorder is characterized by recurrent mood episodes, affecting 1% to 2% of the population. Although its defining features are manic and hypomanic episodes, its course is dominated by depressive syndromes. Diagnosis can be challenging owing to symptom overlap with other disorders. Management goals include early and complete remission of acute episodes and the prevention of relapse between episodes. We present an overview of bipolar disorder and its subtypes, including algorithms and suggestions for screening, assessment, and treatment.

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

The number of benzodiazepine (BZD) prescriptions has substantially increased over the past decade, leading to a parallel rise in rates of misuse and overdose. These increases have prompted the U.S. Food and Drug Administration to update its "boxed warning" and have caused organizations to revisit prescribing guidelines. Concurrently, strong evidence from clinical trials supports the anxiolytic efficacy of BZDs. Although antidepressants and psychotherapy remain preferred treatments for chronic anxiety, BZDs remain helpful in treating acute or severe and persistent anxiety that does not respond to first-line therapy. Provider and patient education, coupled with prescribing surveillance, may be preferable to an overly stringent regulatory approach to guiding BZD use.

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.

ImportanceMedication management and cognitive behavioral therapy (CBT) are commonly used treatments for chronic low back pain (CLBP). However, little evidence is available comparing the effectiveness of these approaches.ObjectiveTo compare collaborative care medication optimization vs CBT on pain intensity, interference, and other pain-related outcomes.Design, Setting, and ParticipantsThe Care Management for the Effective Use of Opioids (CAMEO) trial was a 12-month, comparative effectiveness randomized clinical trial with blinded outcome assessment. Recruitment of veterans with CLBP prescribed long-term opioids occurred at 7 Veterans Affairs primary care clinics from September 1, 2011, to December 31, 2014, and follow-up was completed December 31, 2015. Analyses were based on intention to treat in all randomized participants and were performed from March 22, 2015, to November 1, 2021.InterventionsPatients were randomized to receive either collaborative care with nurse care manager–delivered medication optimization (MED group) (n = 131) or psychologist-delivered CBT (CBT group) (n = 130) for 6 months, with check-in visits at 9 months and final outcome assessment at 12 months.Main Outcomes and MeasuresThe primary outcome was change in Brief Pain Inventory (BPI) total score, a composite of the pain intensity and interference subscales at 6 (treatment completion) and 12 (follow-up completion) months. Scores on the BPI range from 0 to 10, with higher scores representing greater pain impact and a 30% improvement considered a clinically meaningful treatment response. Secondary outcomes included pain-related disability, pain catastrophizing, self-reported substance misuse, health-related quality of life, depression, and anxiety.ResultsA total of 261 patients (241 [92.3%] men; mean [SD] age, 57.9 [9.5] years) were randomized and included in the analysis. Baseline mean (SD) BPI scores in the MED and CBT groups were 6.45 (1.79) and 6.49 (1.67), respectively. Improvements in BPI scores were significantly greater in the MED group at 12 months (between-group difference, −0.54 [95% CI, −1.18 to −0.31]; P = .04) but not at 6 months (between-group difference, −0.46 [95% CI, −0.94 to 0.11]; P = .07). Secondary outcomes did not differ significantly between treatment groups.Conclusions and RelevanceIn this randomized clinical trial among US veterans with CLBP who were prescribed long-term opioid therapy, collaborative care medication optimization was modestly more effective than CBT in reducing pain impact during the 12-month study. However, this difference may not be clinically meaningful or generalize to nonveteran populations.Trial RegistrationClinicalTrials.gov Identifier: NCT01236521

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

Certain immigration factors may increase somatic, anxiety, and depressive (SAD) symptoms in Latinx immigrants. Our study examined prevalence of SAD symptoms in Latinx immigrants 18–29 presenting to primary care with correlates of acculturation, immigration, and legal status. SAD symptoms were measured using the PHQ-14, GAD-7 and PHQ-8. Moderate somatization (37%), anxiety (20%), and depression (25%) were common. Multivariable analysis found five immigration factors predicted a higher composite SAD score and the presence of each additional factor increased likelihood of a SAD score ≥ 20 (OR 1.7; 95% CI, 1.1 to 2.5). SAD scores increased in a dose–response fashion (8.3, 10.5, 14.8, 17.1, 21.7, 29.3) with the added presence of each factor. Elevated SAD scores were not associated with gender, marital status, education, income, country of origin, or acculturation. Screening with our five factor immigration distress index may help identify patients at risk for higher SAD scores during a primary care visit.

Patients with end-stage liver disease (ESLD) commonly experience pain and other symptoms that result in a poor quality of life. Few studies have examined opioid usage, adverse events (AEs), and other outcomes in ESLD patients receiving opioid analgesia.This study aimed to compare outcomes in ESLD patients who received opioids to those who did not and to determine risk factors for AEs.This was a retrospective case-cohort study of 270 hospitalized patients with ESLD that used administrative and clinical data from the electronic medical record.Two-thirds of patients with ESLD admitted during the study period received at least one opioid analgesic. Patients who received opioids presented with a greater number of liver related complications and higher rates of anxiety (32% vs. 17%, p = .007), had substantially worse initial and average pain scores (both p.001), and received more palliative care consultations. The opioid group had somewhat more respiratory (22.2% vs. 11.1%, p = .02) and gastrointestinal (38.5% vs. 25.2%, p = .03) AEs, but no increase in CNS adverse events which included hepatic encephalopathy. Anxiety and disease severity (i.e., the number of liver related complications) but not opioid administration were risk factors for the number of AEs.Opioid administration was not an independent risk factor for the number of AEs in hospitalized patients with ESLD, whereas anxiety and more liver-related complications increased AE risk. Our findings suggest that opioids have an appropriate and reasonably safe role in alleviation of pain in patients with ESLD.

Objectives Perinatal depression (PND) is a prevalent and disabling problem both during pregnancy and the postpartum period. The legacy screening measure has been the Edinburgh Postnatal Depression Scale (EPDS). This systematic review examines the validity of the PHQ-9 as a screener for PND. Methods The following databases were searched from January 2001 (when the PHQ-9 was first published) through June 2020: MEDLINE, Embase, and PsychInfo. Studies that compared the PHQ-9 to a criterion standard psychiatric interview were used to determine the operating characteristics of sensitivity, specificity and area under the curve (AUC). Studies comparing the PHQ-9 to the EPDS and other depression scales evaluated convergent validity. Results A total of 35 articles were eligible for criterion (n = 10) or convergent (n = 25) validity. Meta-analysis of the 7 criterion validity studies using the standard PHQ-9 cut point ≥10 showed a pooled sensitivity, specificity and AUC of 0.84, 0.81 and 0.89, respectively. Operating characteristics of the PHQ-9 and EPDS were nearly identical in head-to-head comparison studies. The median correlation between the PHQ-9 and EPDS was 0.59, and categorical agreement was moderate. Conclusions The PHQ-9 appears to be a viable option for perinatal depression screening with operating characteristics similar to the legacy EPDS.

The PHQ-9 has become a measure of reference in depression research and clinical practice. However, the issue of the PHQ-9's unidimensionality has not been fully elucidated, and the usability of the PHQ-9's total score requires clarification. In this study, we examined the dimensionality, scalability, and monotonicity properties of the PHQ-9 as well as the scale's total-score reliability. We did so based on exploratory structural equation modeling (ESEM) bifactor analysis and Mokken scale analysis (MSA). We relied on a total of 58,272 participants (63% female

In response to the dual public health crises of chronic pain and opioid use, providers have become more vigilant about assessing patients for risk of opioid-related problems. Little is known about how providers are making these risk assessments. Given previous studies indicating that Black patients are at increased risk for suboptimal pain care, which may be related to stereotypes about drug abuse, the current study examined how patient race and previous opioid misuse behaviors impact providers' risk assessments for future prescription opioid-related problems. Physician residents and fellows (N = 135) viewed videos and read vignettes about 8 virtual patients with chronic pain who varied by race (Black/White) and history of prescription opioid misuse (absent/present). Providers rated patients' risk for future prescription opioid-related adverse events, misuse/abuse, addiction, and diversion, and also completed measures of implicit racial attitudes and explicit beliefs about race differences in pain. Two significant interactions emerged indicating that Black patients were perceived to be at greater risk for future adverse events (when previous misuse was absent) and diversion (when previous misuse was present). Significant main effects indicated that Black patients and patients with previous misuse were perceived to be at greater risk for future misuse/abuse of prescription opioids, and that patients with previous misuse were perceived to be at greater risk of addiction. These findings suggest that racial minorities and patients with a history of prescription opioid misuse are particularly vulnerable to any unintended consequences of efforts to stem the dual public health crises of chronic pain and opioid use. (PsycInfo Database Record (c) 2020 APA, all rights reserved).

Background Chronic musculoskeletal pain (MSP) affects more than 40% of adults aged 50 years and older and is the leading cause of disability in the USA. Older adults with chronic MSP are at risk for analgesic-related side effects, long-term opioid use, and functional decline. Recognizing the burden of chronic MSP, reducing the transition from acute to chronic pain is a public health priority. In this paper, we report the protocol for the Brief EducaTional Tool to Enhance Recovery (BETTER) trial. This trial compares two versions of an intervention to usual care for preventing the transition from acute to chronic MSP among older adults in the emergency department (ED). Methods Three hundred sixty patients from the ED will be randomized to one of three arms: full intervention (an interactive educational video about pain medications and recovery-promoting behaviors, a telecare phone call from a nurse 48 to 72 h after discharge from the ED, and an electronic communication containing clinical information to the patient’s primary care provider); video-only intervention (the interactive educational video but no telecare or primary care provider communication); or usual care. Data collection will occur at baseline and at 1 week and 1, 3, 6, and 12 months after study enrollment. The primary outcome is a composite measure of pain severity and interference. Secondary outcomes include physical function, overall health, opioid use, healthcare utilization, and an assessment of the economic value of the intervention. Discussion This trial is the first patient-facing ED-based intervention aimed at helping older adults to better manage their MSP and reduce their risk of developing chronic pain. If effective, future studies will examine the effectiveness of implementation strategies. Trial registration ClinicalTrials.gov NCT04118595. Registered on 8 October 2019.

OBJECTIVES: Growing evidence supports the efficacy of mindfulness-based interventions for symptoms in cancer survivors. Identifying theory-based psychological processes underlying their effects on symptoms would inform research to enhance their efficacy and cost-effectiveness. We conducted secondary analyses examining the effect of mindfulness-based stress reduction (MBSR) for cancer-related fatigue on mindfulness facets, self-compassion, and psychological inflexibility. We also examined whether changes in these processes were associated with the symptom outcomes of fatigue interference, sleep disturbance, and emotional distress. METHODS: Thirty-five persistently fatigued cancer survivors (94% female, 77% breast cancer survivors) were randomized to either MBSR for cancer-related fatigue or a waitlist control (WC) condition. Self-report measures were administered at pre-intervention, post-intervention, and 1-month follow-up. Then the WC group received MBSR and completed a post-intervention follow-up. RESULTS: Linear mixed modeling analyses of the first three time points showed steady increases over time for certain mindfulness facets (observing, acting with awareness, and nonjudging) and self-compassion in favor of the MBSR group. When analyzing pre- and post-intervention data across study conditions, none of the psychological processes predicted change in fatigue interference. However, increased nonjudging was associated with decreased sleep disturbance (β = −.39, p = .003), and increased acting with awareness was associated with decreased emotional distress (β = −.36, p = .003). Self-compassion did not predict change in symptom outcomes. CONCLUSIONS: Results point to specific psychological processes that may be targeted to maximize the efficacy of future MBSR interventions for cancer survivors.

Anxiety disorders are a common underlying cause of symptoms among low-risk chest pain patients evaluated in the emergency department setting. However, anxiety is often undiagnosed and undertreated in any setting, and causes considerable functional impairment to work, family, and social life.The Patient-Centered Treatment of Anxiety after Low-Risk Chest Pain in the Emergency Room (PACER) study is a pragmatic randomized trial to test the comparative effectiveness of existing anxiety treatments of graduated intensities and determine what options work best for patient subgroups based on anxiety severity and other comorbidities.The PACER trial will enroll 375 emergency department patients with low-risk chest pain and anxiety (GAD-7 score ≥ 8) and randomize them to either: 1) referral to primary care with enhanced care coordination, 2) online self-administered cognitive behavioral therapy with guided peer support, or 3) therapist-administered cognitive behavior therapy. Outcomes include anxiety symptoms (primary) as well as physical symptom burden, depression symptoms, functional impairment, ED recidivism, and occurrence of major adverse cardiac events. Statistical analyses will be conducted primarily using linear mixed models to perform a repeated measures analysis of patient-reported outcomes, assessed at 3, 6, 9, and 12-month follow-ups.PACER is an innovative and pragmatic clinical trial that will compare the effectiveness of several evidence-based telecare-delivered treatments for anxiety. Results have the potential to inform clinical guidelines for evaluation and management of low-risk chest pain patients and promote adoption of findings in ED departments across the country.

Opioid-involved motor vehicle traffic fatalities have increased over the past 2 decades. However, the extent to which prescribed opioids increase the risk of motor vehicle crashes remains uncertain. This study used real-world healthcare claims data to examine the association between prescription opioid dose and motor vehicle crash risk. Using nationwide US commercial insurance claims data for 2010 to 2018, we identified 772,404 adults who received incident, noncancer opioid therapy. We examined associations between daily prescription opioid dose, calculated in morphine milligram equivalents (MME) from filled prescription claims, and risk of motor vehicle crashes, assessed as diagnoses of motor vehicle injuries in claims for emergency visits, inpatient hospitalizations, and ambulance transportation. We estimated associations using a within-individual design, which ruled out all time-stable confounding. We complemented the design with time-varying statistical adjustment for other pharmacotherapies and a negative control pain pharmacotherapy analysis (with incident cyclic antidepressant prescriptions). During 2,150,009 person-years of follow-up, there were 12,123 motor vehicle crashes (5.64 crashes per 1000 person-years). In within-individual comparisons, crash risk was greater during opioid prescription periods involving doses ≤60 MME/day (odds ratio [OR], 3.86; 95% confidence interval [CI], 3.54, 4.21),60 to 120 MME/day (OR, 5.46; 95% CI, 4.44, 6.73), and120 MME/day (OR, 3.45; 95% CI, 2.31, 5.15) than during off-treatment periods. The negative control analysis supported the specificity of the results to opioids rather than to other processes associated with pharmacologic pain management. These findings suggest that the receipt of prescription opioids, even at doses ≤60 MME/day, is associated with an increased risk of motor vehicle crashes.

IntroductionDespite calls for screening tools to help providers monitor long-term opioid therapy (LTOT) harms, and identify patients likely to experience harms of discontinuation, such screening tools do not yet exist. Current assessment tools are infeasible to use routinely in primary care and focus mainly on behaviours suggestive of opioid use disorder to the exclusion of other potential harms. This paper describes a study protocol to develop two screening tools that comprise one integrated instrument,Screen toEvaluate andTreat (SET). SET1 will indicate if LTOT may be harmful to continue (yes or no), and SET2 will indicate if tapering to discontinue opioids may be harmful to initiate (yes or no). Patients receiving LTOT who screen positive on the SET tools should receive subsequent additional assessment. SET will give providers methods that are feasible to implement routinely to facilitate more intensive and comprehensive monitoring of patients on LTOT and decision-making about discontinuation.Methods and analysisWe will develop the screening tools, SET1 and SET2, concurrently. Tool development will be done in stages: (1) comprehensive literature searches to yield an initial item pool for domains covered by each screening tool; (2) qualitative item analyses using interviews, expert review and cognitive interviewing, with subsequent item revision, to yield draft versions of each tool; and (3) field testing of the draft screening tools to assess internal consistency, test–retest reliability and convergent and discriminant validity.Ethics and disseminationEthical approval was obtained from the Institutional Review Boards of Stanford University and the University of California, San Francisco for the VA Palo Alto Health Care System, and the VA San Francisco Healthcare System, respectively. Findings will be disseminated through peer-reviewed manuscripts and presentations at research conferences.

Objective The 5 SPADE (sleep, pain, anxiety, depression, and low energy/fatigue) symptoms are among the most prevalent and disabling symptoms in clinical practice. This study evaluates the minimally important difference (MID) of Patient-Reported Outcomes Measurement Information System (PROMIS) measures and their correspondence with other brief measures to assess SPADE symptoms. Study Design and Setting Three hundred primary care patients completed a 4-item PROMIS scale, a numeric rating scale (NRS), and a non-PROMIS legacy scale for each of the 5 SPADE symptoms. Optimal NRS cutpoints were examined, and cross-walk units for converting legacy measure scores to PROMIS scores were determined. PROMIS scores corresponding to standard deviation (SD) and standard error of measurement (SEM) changes in legacy scores were used to estimate MID. Results At an NRS ≥5, the mean PROMIS T-score exceeded 55 (the operational threshold for a clinically meaningful symptom) for each SPADE symptom. Correlations were high (0.70–0.86) between each PROMIS scale and its corresponding non-PROMIS legacy scale. Changes in non-PROMIS legacy scale scores of 0.35 SD and 1 SEM corresponded to mean PROMIS T-scores of 2.92 and 3.05 across the 5 SPADE symptoms, with changes in 0.2 and 0.5 SD corresponding to mean PROMIS T-scores of 1.67 and 4.16. Conclusion A 2-step screening process for SPADE symptoms might use single-item NRS scores, proceeding to PROMIS scales for NRS scores ≥5. A PROMIS T-score change of three points represents a reasonable MID estimate, with two to four points approximating lower and upper bounds.

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.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).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.Six commonly used anxiety scales demonstrate similar responsiveness, and estimated MIDs can be used to gauge anxiety change in clinical research and practice.

ObjectiveSleep 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.DesignParticipants with chronic back pain or hip or knee osteoarthritis pain were randomized to either opioid therapy (N = 120) or nonopioid medication therapy (N = 120).MethodsWe 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.ResultsThe 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 (β = 0.058, P = 0.0002) and BPI severity (β = 0.026, P = 0.0164).ConclusionsBaseline 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.

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

We conducted a randomized controlled trial of an individually tailored, virtual perspective-taking intervention to reduce race and socioeconomic status (SES) disparities in providers' pain treatment decisions. Physician residents and fellows (n = 436) were recruited from across the United States for this two-part online study. Providers first completed a bias assessment task in which they made treatment decisions for virtual patients with chronic pain who varied by race (black/white) and SES (low/high). Providers who demonstrated a treatment bias were randomized to the intervention or control group. The intervention consisted of personalized feedback about their bias, real-time dynamic interactions with virtual patients, and videos depicting how pain impacts the patients' lives. Treatment bias was re-assessed 1 week later. Compared with the control group, providers who received the tailored intervention had 85% lower odds of demonstrating a treatment bias against black patients and 76% lower odds of demonstrating a treatment bias against low SES patients at follow-up. Providers who received the intervention for racial bias also showed increased compassion for patients compared with providers in the control condition. Group differences did not emerge for provider comfort in treating patients. Results suggest an online intervention that is tailored to providers according to their individual treatment biases, delivers feedback about these biases, and provides opportunities for increased contact with black and low SES patients, can produce substantial changes in providers' treatment decisions, resulting in more equitable pain care. Future studies should examine how these effects translate to real-world patient care and the optimal timing/dose of the intervention.

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. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1007/s11606-018-4780-4) contains supplementary material, which is available to authorized users.

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). Develop and assess usability, administration time, and internal reliability of SymTrak. 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. SymTrak and demographic questions. 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. SymTrak demonstrates content validity, positive qualitative findings, high perceived usability, brief self-administered completion time, and good internal reliability.

Pain catastrophizing has been identified as a prognostic indicator of poor outcome following knee arthroplasty. Interventions to address pain catastrophizing, to our knowledge, have not been tested in patients undergoing knee arthroplasty. The purpose of this study was to determine whether pain coping skills training in persons with moderate to high pain catastrophizing undergoing knee arthroplasty improves outcomes 12 months postoperatively compared with usual care or arthritis education. METHODS: A multicenter, 3-arm, single-blinded, randomized comparative effectiveness trial was performed involving 5 university-based medical centers in the United States. There were 402 randomized participants. The primary outcome was the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Scale, measured at baseline, 2 months, 6 months, and 12 months following the surgical procedure. RESULTS: Participants were recruited from January 2013 to June 2016. In 402 participants, 66% were women and the mean age of the participants (and standard deviation) was 63.2 ± 8.0 years. Three hundred and forty-six participants (90% of those who underwent a surgical procedure) completed a 12-month follow-up. All 3 treatment groups had large improvements in 12-month WOMAC pain scores with no significant differences (p > 0.05) among the 3 treatment arms. No differences were found between WOMAC pain scores at 12 months for the pain coping skills and arthritis education groups (adjusted mean difference, 0.3 [95% confidence interval (CI), −0.9 to 1.5]) or between the pain coping and usual-care groups (adjusted mean difference, 0.4 [95% CI, −0.7 to 1.5]). Secondary outcomes also showed no significant differences (p > 0.05) among the 3 groups. CONCLUSIONS: Among adults with pain catastrophizing undergoing knee arthroplasty, cognitive behaviorally based pain coping skills training did not confer pain or functional benefit beyond the large improvements achieved with usual surgical and postoperative care. Future research should develop interventions for the approximately 20% of patients undergoing knee arthroplasty who experience persistent function-limiting pain. LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

Certain immigration factors may increase somatic, anxiety, and depressive (SAD) symptoms in Latinx immigrants. Our study examined prevalence of SAD symptoms in Latinx immigrants 18-29 presenting to primary care with correlates of acculturation, immigration, and legal status. SAD symptoms were measured using the PHQ-14, GAD-7 and PHQ-8. Moderate somatization (37%), anxiety (20%), and depression (25%) were common. Multivariable analysis found five immigration factors predicted a higher composite SAD score and the presence of each additional factor increased likelihood of a SAD score ≥ 20 (OR 1.7; 95% CI, 1.1 to 2.5). SAD scores increased in a dose-response fashion (8.3, 10.5, 14.8, 17.1, 21.7, 29.3) with the added presence of each factor. Elevated SAD scores were not associated with gender, marital status, education, income, country of origin, or acculturation. Screening with our five factor immigration distress index may help identify patients at risk for higher SAD scores during a primary care visit.

Objective Pain, anxiety, and depression (PAD) are common, co-occurring symptoms that adversely affect one another and may respond to common treatments. PAD composite measures would be useful for tracking treatment response in patients with PAD symptoms. The goal of this study is to compare 3 different PAD composite scales in terms of construct validity, responsiveness, and utility in predicting global improvement. Method The sample consisted of 294 primary care patients enrolled in a telecare trial for treating pain, anxiety, and depression. Assessments at baseline and 3 months included the Brief Pain Inventory, PHQ-9 depression scale, GAD-7 anxiety scale, PROMIS measures, Medical Outcomes Study Short-Form items, disability measures, and patient-reported global improvement. Construct validity of the PAD composite measures, their responsiveness, and their ability to predict global improvement was analyzed using Pearson correlations, standardized response means, and receiver operating characteristics analysis. Results PAD composite measures correlated strongly with one another, and moderately with measures of function, vitality, and disability. Each PAD composite measure demonstrated similar responsiveness in detecting improvement at 3 months as assessed by standardized response means (SRMs) and area under the curve (AUC analyses).The SRMs for partial and substantial global improvement corresponded to moderate (Cohen's d of 0.58 to 0.69) and large (0.81 to 0.93) effect sizes, respectively. Conclusions Three different PAD composite measures demonstrate good construct validity as well as responsiveness in detecting global improvement of pain, anxiety and depression at 3 months.

Background Fatigue interference with activities, mood, and cognition is one of the most prevalent and bothersome concerns of advanced gastrointestinal (GI) cancer patients. As fatigue interferes with patient functioning, family caregivers often report feeling burdened by increasing responsibilities. Evidence-based interventions jointly addressing cancer patient fatigue interference and caregiver burden are lacking. In pilot studies, acceptance and commitment therapy (ACT) has shown promise for addressing symptom-related suffering in cancer patients. The current pilot trial seeks to test a novel, dyadic ACT intervention for both advanced GI cancer patients with moderate-to-severe fatigue interference and their family caregivers with significant caregiving burden or distress. Methods A minimum of 40 patient-caregiver dyads will be randomly assigned to either the ACT intervention or an education/support control condition. Dyads in both conditions attend six weekly 50-min telephone sessions. Outcomes are assessed at baseline as well as 2 weeks and 3 months post-intervention. We will evaluate the feasibility, acceptability, and preliminary efficacy of ACT for improving patient fatigue interference and caregiver burden. Secondary outcomes include patient sleep interference and patient and caregiver engagement in daily activities, psychological flexibility, and quality of life. We will also explore the effects of ACT on patient and caregiver physical and mental health service use. Discussion Findings will inform a large-scale trial of intervention efficacy. Results will also lay the groundwork for further novel applications of ACT to symptom interference with functioning and caregiver burden in advanced cancer. Trial Registration ClinicalTrials.gov, NCT04010227. Registered 8 July 2019.