Impact of pain and adverse health outcomes on long-term US testicular cancer survivors.

BACKGROUND: No study has quantified the impact of pain and other adverse health outcomes on global physical and mental health in long-term US testicular cancer survivors or evaluated patient-reported functional impairment due to pain. METHODS: Testicular cancer survivors given cisplatin-based chemotherapy completed validated surveys, including Patient-Reported Outcomes Measurement Information System v1.2 global physical and mental health, Patient-Reported Outcomes Measurement Information System pain questionnaires, and others. Multivariable linear regression examined relationships between 25 adverse health outcomes with global physical and mental health and pain-interference scores. Adverse health outcomes with a ß^ of more than 2 are clinically important and reported below. RESULTS: Among 358 testicular cancer survivors (median age = 46 years, interquartile range [IQR] = 38-53 years; median time since chemotherapy = 10.7 years, IQR = 7.2-16.0 years), median adverse health outcomes number was 5 (IQR = 3-7). A total of 12% testicular cancer survivors had 10 or more adverse health outcomes, and 19% reported chemotherapy-induced neuropathic pain. Increasing adverse health outcome numbers were associated with decreases in physical and mental health (P < .0001 each). In multivariable analyses, chemotherapy-induced neuropathic pain (ß^ = -3.72; P = .001), diabetes (ß^ = -4.41; P = .037), obesity (ß^ = -2.01; P = .036), and fatigue (ß^ = -8.58; P < .0001) were associated with worse global mental health, while being married or living as married benefited global mental health (ß^ = 3.63; P = .0006). Risk factors for pain-related functional impairment included lower extremity location (ß^ = 2.15; P = .04) and concomitant peripheral artery disease (ß^ = 4.68; P < .001). Global physical health score reductions were associated with diabetes (ß^ = -3.81; P = .012), balance or equilibrium problems (ß^ = -3.82; P = .003), cognitive dysfunction (ß^ = -4.43; P < .0001), obesity (ß^ = -3.09; P < .0001), peripheral neuropathy score (ß^ = -2.12; P < .0001), and depression (ß^ = -3.17; P < .0001). CONCLUSIONS: Testicular cancer survivors suffer adverse health outcomes that negatively impact long-term global mental health, global physical health, and pain-related functional status. Clinically important factors associated with worse physical and mental health identify testicular cancer survivors requiring closer monitoring, counseling, and interventions. Chemotherapy-induced neuropathic pain must be addressed, given its detrimental impact on patient-reported functional status and mental health 10 or more years after treatment.

Physician views of artificial intelligence in otolaryngology and rhinology: A mixed methods study.

Objective: The study aimed to investigate otolaryngologists' knowledge, trust, acceptance, and concerns with clinical applications of artificial intelligence (AI). Methods: This study used mixed methods with survey and semistructured interviews. Survey was e-mailed to American Rhinologic Society members, of which a volunteer sample of 86 members responded. Nineteen otolaryngologists were purposefully recruited and interviewed until thematic saturation was achieved. Results: Seventy-six respondents (10% response rate) completed the majority of the survey: 49% worked in academic settings and 43% completed residency 10 or fewer years ago. Of 19 interviewees, 58% worked in academic settings, and 47% completed residency 10 or fewer years ago. Familiarity: Only 8% of survey respondents reported having AI training in residency, although 72% had familiarity with general AI concepts; 0 interviewees had personal experience with AI in clinical settings. Expected uses: Of the surveyed otolaryngologists, 82% would use an AI-based clinical decision aid and 74% were comfortable with AI proposing treatment recommendations. However, only 44% of participants would trust AI to identify malignancy and 53% to interpret radiographic images. Interviewees trusted AI for simple tasks, such as labeling septal deviation, more than complex ones, such as identifying tumors. Factors influencing AI adoption: 89% of survey participants would use AI if it improved patient satisfaction, 78% would be willing to use AI if experts and studies validated the technologies, and 73% would only use AI if it increased efficiency. Sixty-one percent of survey respondents expected AI incorporation into clinical practice within 5 years. Interviewees emphasized that AI adoption depends on its similarity to their clinical judgment and to expert opinion. Concerns included nuanced or complex cases, poor design or accuracy, and the personal nature of physician-patient relationships. Conclusion: Few physicians have experience with AI technologies but expect rapid adoption in the clinic, highlighting the urgent need for clinical education and research. Otolaryngologists are most receptive to AI "augmenting" physician expertise and administrative capacity, with respect for physician autonomy and maintaining relationships with patients. Level of Evidence: Level VI, descriptive or qualitative study.

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.

Indiana Palliative Excellence in Alzheimer's Care Efforts (IN-PEACE): Protocol for a randomized controlled trial in persons with advanced dementia.

BACKGROUND: Dementia affects 6.5 million persons in the U.S., a number which is expected to double by 2060. More than half of persons with dementia die at home, creating an enormous burden for both patients and caregivers. However, there is a paucity of research on community-based palliative care interventions for advanced dementia. OBJECTIVES: The Indiana Palliative Excellence in Alzheimer's Care Efforts (IN-PEACE) study is a randomized trial to test the effectiveness of a collaborative predominantly telehealth home-based intervention for persons with advanced dementia residing in the community and their primary, informal caregivers. The primary aim is to determine if this palliative care focused supportive intervention is superior to usual care in reducing neuropsychiatric symptoms of dementia. Secondarily, intervention effects on other patient symptoms (e.g., pain), caregiver distress and depression, and emergency department (ED)/hospitalization events are examined. METHODS: The study population consists of participant pairs comprising a person with dementia and their primary, informal caregiver. The person with dementia must be ≥65 years old, with a clinical diagnosis of moderate to severe dementia. A total of 201 demographically and socioeconomically diverse participant pairs have been randomized to the IN-PEACE care coordination intervention (n = 99) or usual care (n = 102). Outcome assessments are conducted at baseline, and quarterly for up to 2 years (3, 6, 9, 12, 15, 18, 21, and 24 months). DISCUSSION: IN-PEACE results will inform care for the large number of individuals with advanced dementia residing in the community and enable informal caregivers to provide effective home-based care. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT03773757.

Prevalence, Severity, and Co-Occurrence of SPPADE Symptoms in 31,866 Patients With Cancer.

OBJECTIVES: To examine the prevalence, severity, and co-occurrence of SPPADE symptoms as well as their association with cancer type and patient characteristics. BACKGROUND: The SPPADE symptoms (sleep disturbance, pain, physical function impairment, anxiety, depression, and low energy /fatigue) are prevalent, co-occurring, and undertreated in oncology and other clinical populations. METHODS: Baseline SPPADE symptom data were analyzed from the E2C2 study, a stepped wedge pragmatic, population-level, cluster randomized clinical trial designed to evaluate a guideline-informed symptom management model targeting the six SPPADE symptoms. Symptom prevalence and severity were measured with a 0-10 numeric rating (NRS) scale for each of the six symptoms. Prevalence of severe (NRS ≥ 7) and potential clinically relevant (NRS ≥ 5) symptoms as well as co-occurrence of clinical symptoms were determined. Distribution-based methods were used to estimate the minimally important difference (MID). Associations of cancer type and patient characteristics with a SPPADE composite score were analyzed. RESULTS: A total of 31,886 patients were assessed for SPPADE symptoms prior to, during, or soon after an outpatient medical oncology encounter. The proportion of patients with a potential clinically relevant symptom ranged from 17.5% for depression to 33.4% for fatigue. Co-occurrence of symptoms was high, with the proportion of patients with three or more additional clinically relevant symptoms ranging from 45.2% for fatigue to 68.6% for depression. The summed SPPADE composite score demonstrated good internal reliability (Cronbach's alpha of 0.86), with preliminary MID estimates of 4.1-4.3. Symptom burden differed across several types of cancer but was generally similar across most sociodemographic characteristics. CONCLUSION: The high prevalence and co-occurrence of SPPADE symptoms in patients with all types of cancer warrants clinical approaches that optimize detection and management.

Pragmatic cluster randomized trial to evaluate effectiveness and implementation of EHR-facilitated collaborative symptom control in cancer (E2C2): addendum.

We previously described the hypotheses, outcomes, design, and analysis for E2C2, a pragmatic stepped-wedge trial to assess an intervention to improve symptom control in patients with cancer. Subsequent consideration of the design and cohort led to the addition of a second primary hypothesis. This article describes and presents the rationale for this second hypothesis. This addendum also details a revised analytic approach, necessitated by inconsistencies in the original analytic plan. The design, outcomes, and other aspects of the protocol remain unchanged.

Patient-Reported Functional Impairment Due to Hearing Loss and Tinnitus After Cisplatin-Based Chemotherapy.

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.

Comparative responsiveness and minimally important difference of Fatigue Symptom Inventory (FSI) scales and the FSI-3 in trials with cancer survivors.

BACKGROUND: Fatigue is a highly prevalent and disabling symptom in cancer survivors. Although many measures have been developed to assess survivors' fatigue, their ability to accurately capture change following intervention has rarely been assessed in post-treatment survivors. Ultra-brief fatigue measures are preferable in clinical practice but have limited evidence supporting their use with cancer survivors. We examined the psychometric properties of four Fatigue Symptom Inventory (FSI) measures, including the new FSI-3, in cancer survivors. Examined properties included responsiveness to change and minimally important differences (MIDs). METHODS: We analyzed data from three randomized controlled trials with post-treatment cancer survivors (N = 328). Responsiveness to change was evaluated by comparing standardized response means for survivors who reported their fatigue as being better, the same, or worse at 2-3 months. Responsiveness to intervention was assessed via effect sizes, and MIDs were estimated by using several methods. We also computed area under the curve (AUC) values to assess FSI measures' discriminative accuracy compared to an established cut-point. RESULTS: All FSI measures differentiated survivors who reported improvement at 2-3 months from those with stable fatigue, but did not uniformly differentiate worsening fatigue from stable fatigue. Measures showed similar levels of responsiveness to intervention, and MIDs ranged from 0.29 to 2.20 across FSI measures. AUC analyses supported the measures' ability to detect significant fatigue. CONCLUSIONS: Four FSI scales show similar responsiveness to change, and estimated MIDs can inform assessment of meaningful change in fatigue. The FSI-3 shows promise as an ultra-brief fatigue measure for survivors.

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.

Development and field testing of primary care screening tools for harms of long-term opioid therapy continuation and tapering to discontinuation: a study protocol.

INTRODUCTION: Despite 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 to Evaluate and Treat (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 ANALYSIS: We 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 DISSEMINATION: Ethical 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.

Diagnostic operating characteristics of PROMIS scales in screening for depression.

OBJECTIVE: To determine the diagnostic operating characteristics of The Patient Reported Outcomes Measurement Information Systems (PROMIS) depression scales in screening for major depression. METHODS: Interview data from patients enrolled in clinical trials involving patients with chronic pain (2 trials) or post-stroke (1 trial) were analyzed. This included baseline and follow-up interviews in 648 and 586 study patients, respectively. Patients completed PROMIS depression scales of varying lengths (4-item, 6-item, and two 8-item scale versions) as well as the Patient Health Questionnaire 9-item (PHQ-9) depression scale. A Structured Clinical Interview for DSM Disorders (SCID) was administered to establish diagnoses of major depression and any depression. Sensitivity and specificity at various score cutpoints as well as area under the curve (AUC) were calculated. RESULTS: PROMIS scales of varying lengths had similar diagnostic operating characteristics. The optimal screening cutpoint for PROMIS raw scores on the 4-, 6-, and 8-item scales was 8, 12, and 16, respectively, which corresponds to a PROMIS T-score of 55. The average sensitivity and specificity of the two PROMIS 8-item scales for major depression across the 3 trials using a T-score cutpoint ≥55 was 0.81 and 0.84, respectively. This was almost identical to 0.81 and 0.82 for the PHQ-9 at its standard cutpoint score ≥ 10. The average AUC for major depression was identical (0.91) for the two PROMIS 8-item scales and PHQ-9, and also similar for any depression (0.87 to 0.89). CONCLUSION: PROMIS scales ranging from 4 to 8 items have strong operating characteristics comparable to the PHQ-9 in screening for depression. TRIAL REGISTRATION: ClinicalTrials.gov ID: NCT01236521, NCT01583985, NCT01507688.

Use of Medications for Treating Anxiety or Depression among Testicular Cancer Survivors: A Multi-Institutional Study.

BACKGROUND: This study examined sociodemographic factors, cisplatin-related adverse health outcomes (AHO), and cumulative burden of morbidity (CBMPt) scores associated with medication use for anxiety and/or depression in testicular cancer survivors (TCS). METHODS: A total of 1,802 TCS who completed cisplatin-based chemotherapy ≥12 months previously completed questionnaires regarding sociodemographic features and cisplatin-related AHOs [hearing impairment, tinnitus, peripheral sensory neuropathy (PSN), and kidney disease]. A CBMPt score encompassed the number and severity of cisplatin-related AHOs. Multivariable logistic regression models assessed the relationship of individual AHOs and CBMPt with medication use for anxiety and/or depression. RESULTS: A total of 151 TCS (8.4%) used medications for anxiety and/or depression. No cisplatin-related AHOs were reported by 511 (28.4%) participants, whereas 622 (34.5%), 334 (18.5%), 287 (15.9%), and 48 (2.7%), respectively, had very low, low, medium, and high CBMPt scores. In the multivariable model, higher CBMPt scores were significantly associated with medication use for anxiety and/or depression (P < 0.0001). In addition, tinnitus (P = 0.0009), PSN (P = 0.02), and having health insurance (P = 0.05) were significantly associated with greater use of these medications, whereas being employed (P = 0.0005) and vigorous physical activity (P = 0.01) were significantly associated with diminished use. CONCLUSIONS: TCS with higher CBMPt scores had a higher probability of using medications for anxiety and/or depression, and conversely, those who were employed and physically active tended to have reduced use of these medications. IMPACT: Healthcare providers should encourage TCS to increase physical activity to improve both physical and mental health. Rehabilitation programs should assess work-related skills and provide career development counseling/training.

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

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.

Screening for perinatal depression with the Patient Health Questionnaire depression scale (PHQ-9): A systematic review and meta-analysis.

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.

Predictors of depression outcomes in adults with cancer: A 12 month longitudinal study.

OBJECTIVES: The prevalence of depression in patients with cancer ranges from 8% to 24% within the first year of receiving a cancer diagnosis. Identifying predictors of depression outcomes may facilitate tailored or more intensive treatment in patient subgroups with a poorer prognosis for depression improvement. The objective of this study was to determine predictors of depression severity and improvement over 12 months among adults with cancer. METHODS: Longitudinal analysis of data from the Indiana Cancer Pain and Depression trial was performed in 309 patients (n = 309) with cancer-related depression. Depression outcomes were assessed at baseline, 1, 3, 6, and 12 months and included depression severity (Hopkins Symptom Checklist-20) and global improvement (Depression Global Rating of Improvement (DGRI)). Multivariable repeated measures analyses, adjusting for treatment group, baseline depression, and time point, were conducted to determine symptom (pain), demographic, and clinical predictors of depression outcomes over 12 months. RESULTS: Pain was particularly important, with a clinically meaningful reduction in pain predicting a 12-24% greater odds of depression global improvement. Other factors that independently predicted better depression outcomes over 12 months included female sex, newly-diagnosed or maintainence/disease-free cancer, fewer comorbid medical conditions, and higher socioeconomic status. As expected, the three covariates adjusted for in the model (treatment group, passage of time, and baseline depression severity) also predicted depression outcomes. CONCLUSION: Pain as well as several demographic and clinical factors predict depression outcomes over 12 months. These findings may help identify patient subgroups requiring closer monitoring and more intensive or tailored depression treatment. Trial Registration clinicaltrials.gov Identifier: NCT00313573.

Disentangling trait versus state characteristics of the Pain Catastrophizing Scale and the PHQ-8 Depression Scale.

BACKGROUND: Research on the role of trait versus state characteristics of a variety of measures among persons experiencing pain has been a focus for the past few decades. Studying the trait versus state nature of the Pain Catastrophizing Scale (PCS) and the Patient Health Questionnaire (PHQ-8) depression scale would be highly informative given both are commonly measured in pain populations and neither scale has been studied for trait/state contributions. METHODS: The PHQ-8 and PCS were obtained on persons undergoing knee arthroplasty at baseline, 2-, 6- and 12-month post-surgery (N = 402). The multi-trait generalization of the latent trait-state model was used to partition trait and state variability in PCS and PHQ-8 item responses simultaneously. A set of variables were used to predict trait catastrophizing and trait depression. RESULTS: For total scores, the latent traits and latent states explain 63.2% (trait = 43.2%; state = 20.0%) and 50.2% (trait = 29.4%; state = 20.8%) of the variability in PCS and PHQ-8, respectively. Patients with a high number of bodily pain sites, high levels of anxiety, young patients and African-American patients had high levels of trait catastrophizing and trait depression. The PCS and the PHQ-8 consist of both enduring trait and dynamic state characteristics, with trait characteristics dominating for both measures. CONCLUSION: Clinicians and researchers using these scales should not assume the obtained measurements solely reflect either trait- or state-based characteristics. SIGNIFICANCE: Clinicians and researchers using the PCS or PHQ-8 scales are measuring both state and trait characteristics and not just trait- or state-based characteristics.

Psychological Processes and Symptom Outcomes in Mindfulness-Based Stress Reduction for Cancer Survivors: A Pilot Study.

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 (ß = -.39, p = .003), and increased acting with awareness was associated with decreased emotional distress (ß = -.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.

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.

Effect of Collaborative Telerehabilitation on Functional Impairment and Pain Among Patients With Advanced-Stage Cancer: A Randomized Clinical Trial.

IMPORTANCE: Most patients with advanced-stage cancer develop impairment and pain-driven functional losses that jeopardize their independence. OBJECTIVE: To determine whether collaborative telerehabilitation and pharmacological pain management improve function, lessen pain, and reduce requirements for inpatient care. DESIGN, SETTING, AND PATIENTS: The Collaborative Care to Preserve Performance in Cancer (COPE) study was a 3-arm randomized clinical trial conducted at 3 academic medical centers within 1 health care system. Patient recruitment began in March 2013 and follow-up concluded in October 2016. Participants (N = 516) were low-level community or household ambulators with stage IIIC or IV solid or hematologic cancer. INTERVENTIONS: Participants were randomly assigned to the (1) control arm, (2) telerehabilitation arm, or (3) telerehabilitation with pharmacological pain management arm. All patients underwent automated function and pain monitoring with data reporting to their care teams. Participants in arms 2 and 3 received 6 months of centralized telerehabilitation provided by a physical therapist-physician team. Those in arm 3 also received nurse-coordinated pharmacological pain management. MAIN OUTCOMES AND MEASURES: Blinded assessment of function using the Activity Measure for Postacute Care computer adaptive test, pain interference and average intensity using the Brief Pain Inventory, and quality of life using the EQ-5D-3L was performed at baseline and months 3 and 6. Hospitalizations and discharges to postacute care facilities were recorded. RESULTS: The study included 516 participants (257 women and 259 men; mean [SD] age, 65.6 [11.1] years), with 172 randomized to 1 of 3 arms. Compared with the control group, the telerehabilitation arm 2 had improved function (difference, 1.3; 95% CI, 0.08-2.35; P = .03) and quality of life (difference, 0.04; 95% CI, 0.004-0.071; P = .01), while both telerehabilitation arms 2 and 3 had reduced pain interference (arm 2, -0.4; 95% CI, -0.78 to -0.09; P = .01 and arm 3, -0.4; 95% CI, -0.79 to -0.10; P = .01), and average intensity (arm 2, -0.4; 95% CI, -0.78 to -0.07; P = .02 and arm 3, -0.5; 95% CI, -0.84 to -0.11; P = .006). Telerehabilitation was associated with higher odds of home discharge in arms 2 (odds ratio [OR], 4.3; 95% CI, 1.3-14.3; P = .02) and 3 (OR, 3.8; 95% CI, 1.1-12.4; P = .03) and fewer days in the hospital in arm 2 (difference, -3.9 days; 95% CI, -2.4 to -4.6; P = .01). CONCLUSIONS AND RELEVANCE: Collaborative telerehabilitation modestly improved function and pain, while decreasing hospital length of stay and the requirement for postacute care, but these outcomes were not enhanced with the addition of pharmacological pain management. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT01721343.