A pharmacist intervention for outpatients with heart failure can improve adherence to cardiovascular medications and decrease health care use and costs, but the benefit probably requires constant intervention because the effect dissipates when the intervention ceases. ClinicalTrials.gov registration number: NCT00388622.
Pain and depression are the most prevalent physical and psychological symptom-based disorders, respectively, and co-occur 30–50% of the time. However, their reciprocal relationship and potentially causative effects on one another have been inadequately studied. Longitudinal data analysis involving 500 primary care patients with persistent back, hip or knee pain were enrolled in the Stepped Care for Affective Disorders and Musculoskeletal Pain (SCAMP) study. Half of the participants had comorbid depression and were randomized to a stepped care intervention (n = 123) or treatment as usual (n = 127). Another 250 nondepressed patients with similar pain were followed in a parallel cohort. Outcomes were assessed at baseline, 3, 6, and 12 months. Mixed effects model repeated measures (MMRM) multivariable analyses were conducted to determine if change in pain severity predicted subsequent depression severity, and vice-versa. Change in pain was a strong predictor of subsequent depression severity (t-value = 6.63, p < .0001). Likewise, change in depression severity was an equally strong predictor of subsequent pain severity (t-value = 7.28, p < .0001). Results from the full cohort were similar in the clinical trial subgroup. In summary, pain and depression have strong and similar effects on one another when assessed longitudinally over 12 months.
OBJECTIVE To assess the relationship between depression and anxiety comorbidity on pain intensity, pain-related disability, and health-related quality of life (HRQL). METHODS Analysis of baseline data from the Stepped Care for Affective disorders and Musculoskeletal Pain (SCAMP) Study. All patients (N = 500) had chronic pain (≥ 3 months duration) of the low back, hip or knee. Patients with depression were over-sampled for the clinical trial component of SCAMP and thus represented 50% of the study population. Patients were categorized according to pain comorbid with depression, anxiety, or both. We used ANOVA and MANOVA models to asess relationships between independent and dependent variables. RESULTS Participants had a mean age of 59 years; were 55% women, 56% white and 40% black. Fifty-four percent (n=271) reported pain only, 20% (n=98) had pain and depression, 3% (n=15) had pain and anxiety, and 23% (n=116) had pain, depression, and anxiety. Patients with pain and both depression and anxiety experienced the greatest pain severity (p < .0001) and pain-related disability (p < .0001). Psychiatric comorbidity was strongly associated with disability days in the past 3 months (p < .0001), with 18.1 days reported by patients with pain only, 32.2 days by those with pain and anxiety, 38.0 days by those with pain and depression, and 42.6 days in those with all three conditions. We found a similar pattern of poorer HRQL (p <.0001) in those with pain, depression, and anxiety. CONCLUSIONS The added morbidity of depression and anxiety with chronic pain is strongly associated with more severe pain, greater disability, and poorer HRQL.
BACKGROUND: Inadequate pain assessment is a barrier to appropriate pain management, but single-item "pain screening" provides limited information about chronic pain. Multidimensional pain measures such as the Brief Pain Inventory (BPI) are widely used in pain specialty and research settings, but are impractical for primary care. A brief and straightforward multidimensional pain measure could potentially improve initial assessment and followup of chronic pain in primary care. OBJECTIVES:To develop an ultra-brief pain measure derived from the BPI.DESIGN: Development of a shortened three-item pain measure and initial assessment of its reliability, validity, and responsiveness. PARTICIPANTS:We used data from 1) a longitudinal study of 500 primary care patients with chronic pain and 2) a cross-sectional study of 646 veterans recruited from ambulatory care.RESULTS: Selected items assess average pain intensity (P), interference with enjoyment of life (E), and interference with general activity (G). Reliability of the threeitem scale (PEG) was α=0.73 and 0.89 in the two study samples. Overall, construct validity of the PEG was good for various pain-specific measures (r=0.60-0.89 in Study 1 and r=0.77-0.95 in Study 2), and comparable to that of the BPI. The PEG was sensitive to change and differentiated between patients with and without pain improvement at 6 months. DISCUSSION:We provide strong initial evidence for reliability, construct validity, and responsiveness of the PEG among primary care and other ambulatory clinic patients. The PEG may be a practical and useful tool to improve assessment and monitoring of chronic pain in primary care.
Context Pain and depression are the most common physical and psychological symptoms in primary care, respectively. Moreover, they co-occur 30% to 50% of the time and have adverse effects on quality of life, disability, and health care costs.Objective To determine if a combined pharmacological and behavioral intervention improves both depression and pain in primary care patients with musculoskeletal pain and comorbid depression. Design, Setting, and Patients Randomized controlled trial (Stepped Care for Affective Disorders and Musculoskeletal Pain [SCAMP]) conducted at 6 communitybased clinics and 5 Veterans Affairs general medicine clinics in Indianapolis, Indiana. Recruitment occurred from January 2005 to June 2007 and follow-up concluded in June 2008. The 250 patients had low back, hip, or knee pain for 3 months or longer and at least moderate depression severity (Patient Health Questionnaire 9 score Ն10).Intervention Patients were randomly assigned to the intervention (n=123) or to usual care (n=127). The intervention consisted of 12 weeks of optimized antidepressant therapy (step 1) followed by 6 sessions of a pain self-management program over 12 weeks (step 2), and a continuation phase of therapy for 6 months (step 3).Main Outcome Measures Depression (20-item Hopkins Symptom Checklist), pain severity and interference (Brief Pain Inventory), and global improvement in pain at 12 months.Results At 12 months, 46 of the 123 intervention patients (37.4%) had a 50% or greater reduction in depression severity from baseline compared with 21 of 127 usual care patients (16.5%) (relative risk [RR], 2.3; 95% confidence interval [CI], 1.5-3.2), corresponding to a much lower number of patients with major depression (50 [40.7%] vs 87 [68.5%], respectively; RR, 0.6 [95% CI, 0.4-0.8]). Also, a clinically significant (Ն30%) reduction in pain was much more likely in intervention patients (51 intervention patients [41.5%] vs 22 usual care patients [17.3%]; RR, 2.4 [95% CI, 1.6-3.2]), as was global improvement in pain (58 [47.2%] vs 16 [12.6%], respectively; RR, 3.7 [95% CI, 2.3-6.1]). More intervention patients also experienced benefits in terms of the primary outcome, which was a combined improvement in both depression and pain (32 intervention patients [26.0%] vs 10 usual care patients [7.9%]; RR, 3.3 [95% CI, 1.8-5.4]). ConclusionOptimized antidepressant therapy followed by a pain selfmanagement program resulted in substantial improvement in depression as well as moderate reductions in pain severity and disability.
Context Pain and depression are two of the most prevalent and treatable cancer-related symptoms, yet frequently go unrecognized and/or undertreated. Objective To determine whether centralized telephone-based care management coupled with automated symptom monitoring can improve depression and pain in cancer patients. Design, Setting, and Patients Randomized controlled trial conducted in 16 community-based urban and rural oncology practices across the state of Indiana. Recruitment occurred from March 2006 through August 2008 and follow-up concluded in August 2009. The 405 patients had depression (Patient Health Questionnaire-9 score ≥ 10), cancer-related pain (Brief Pain Inventory worst pain score ≥ 6), or both. Intervention Patients were randomly assigned to the intervention (n=202) or to usual care (n=203), stratified by symptom type. Intervention patients received centralized telecare management by a nurse-physician specialist team coupled with automated home-based symptom monitoring by interactive voice recording or internet. Main Outcome Measures Blinded assessment at baseline, 1, 3, 6, and 12 months for depression (20-item Hopkins Symptom Checklist [HSCL-20]) and pain (Brief Pain Inventory [BPI]) severity. Results There were 131 patients enrolled with depression only, 96 with pain only, and 178 with both depression and pain. Of the 274 patients enrolled for pain, the 137 intervention patients had greater improvements than the 137 usual care patients in BPI pain severity over the 12 months of the trial whether measured as a continuous severity score or as a categorical pain responder (P < .0001 for both). Similarly, of the 309 patients enrolled for depression, the 154 intervention patients had greater improvements than the 155 usual care patients in HSCL-20 depression severity over the 12 months of the trial whether measured as a continuous severity score (P < .0001) or as a categorical depression responder (P < .001). The standardized effect size for between-group differences at 3 and 12 months was .67 and .39 for pain, and .42 and .44 for depression. Conclusion Centralized telecare management coupled with automated symptom monitoring resulted in improved pain and depression outcomes in cancer patients receiving care in geographically-dispersed urban and rural oncology practices.
Objective We examine the reliability and validity of the Patient Health Questionnaire Anxiety-Depression Scale (PHQ-ADS) – which combines the PHQ-9 and GAD-7 scales – as a composite measure of depression and anxiety. Methods Baseline data from 896 patients enrolled in 2 primary-care based trials of chronic pain and 1 oncology-practice based trial of depression and pain were analyzed. The internal reliability, standard error of measurement (SEM), and convergent, construct, and factor structure validity, as well as sensitivity to change of the PHQ-ADS were examined. Results The PHQ-ADS demonstrated high internal reliability (Cronbach's alpha of 0.8 to 0.9) in all 3 trials. PHQ-ADS scores can range from 0 to 48 (with higher scores indicating more severe depression/anxiety), and the estimated SEM was approximately 3 to 4 points. The PHQ-ADS showed strong convergent (most correlations 0.7-0.8 range) and construct (most correlations 0.4-0.6 range) validity when examining its association with other mental health, quality of life and disability measures. PHQ-ADS cutpoints of 10, 20, and 30 indicated mild, moderate, and severe levels of depression/anxiety, respectively. Bi-factor analysis showed sufficient unidimensionality of the PHQ-ADS score. PHQ-ADS change scores at 3 months differentiated (P < .0001) between individuals classified as worse, stable, or improved by a reference measure, providing preliminary evidence for sensitivity to change. Conclusions The PHQ-ADS may be a reliable and valid composite measure of depression and anxiety which, if validated in other populations, could be useful as a single measure for jointly assessing two of the most common psychological conditions in clinical practice and research. Trial Registration clinicaltrials.gov Identifier: NCT00926588 (SCOPE); NCT00386243 (ESCAPE); NCT00313573 (INCPAD);
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