Mark T. Hegel

Effects of a Palliative Care Intervention on Clinical Outcomes in Patients With Advanced Cancer: The Project ENABLE II Randomized Controlled Trial

CONTEXT There are few randomized controlled trials on the effectiveness of palliative care interventions to improve the care of patients with advanced cancer. OBJECTIVE To determine the effect of a nursing-led intervention on quality of life, symptom intensity, mood, and resource use in patients with advanced cancer. DESIGN, SETTING, AND PARTICIPANTS Randomized controlled trial conducted from November 2003 through May 2008 of 322 patients with advanced cancer in a rural, National Cancer Institute-designated comprehensive cancer center in New Hampshire and affiliated outreach clinics and a VA medical center in Vermont. INTERVENTIONS A multicomponent, psychoeducational intervention (Project ENABLE [Educate, Nurture, Advise, Before Life Ends]) conducted by advanced practice nurses consisting of 4 weekly educational sessions and monthly follow-up sessions until death or study completion (n = 161) vs usual care (n = 161). MAIN OUTCOME MEASURES Quality of life was measured by the Functional Assessment of Chronic Illness Therapy for Palliative Care (score range, 0-184). Symptom intensity was measured by the Edmonton Symptom Assessment Scale (score range, 0-900). Mood was measured by the Center for Epidemiological Studies Depression Scale (range, 0-60). These measures were assessed at baseline, 1 month, and every 3 months until death or study completion. Intensity of service was measured as the number of days in the hospital and in the intensive care unit (ICU) and the number of emergency department visits recorded in the electronic medical record. RESULTS A total of 322 participants with cancer of the gastrointestinal tract (41%; 67 in the usual care group vs 66 in the intervention group), lung (36%; 58 vs 59), genitourinary tract (12%; 20 vs 19), and breast (10%; 16 vs 17) were randomized. The estimated treatment effects (intervention minus usual care) for all participants were a mean (SE) of 4.6 (2) for quality of life (P = .02), -27.8 (15) for symptom intensity (P = .06), and -1.8 (0.81) for depressed mood (P = .02). The estimated treatment effects in participants who died during the study were a mean (SE) of 8.6 (3.6) for quality of life (P = .02), -24.2 (20.5) for symptom intensity (P = .24), and -2.7 (1.2) for depressed mood (P = .03). Intensity of service did not differ between the 2 groups. CONCLUSION Compared with participants receiving usual oncology care, those receiving a nurse-led, palliative care-focused intervention addressing physical, psychosocial, and care coordination provided concurrently with oncology care had higher scores for quality of life and mood, but did not have improvements in symptom intensity scores or reduced days in the hospital or ICU or emergency department visits. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00253383.

Escitalopram and Problem-Solving Therapy for Prevention of Poststroke Depression: A Randomized Controlled Trial

CONTEXT Depression occurs in more than half of patients who have experienced a stroke. Poststroke depression has been shown in numerous studies to be associated with both impaired recovery in activities of daily living and increased mortality. Prevention of depression thus represents a potentially important goal. OBJECTIVE To determine whether treatment with escitalopram or problem-solving therapy over the first year following acute stroke will decrease the number of depression cases that develop compared with placebo medication. DESIGN, SETTING, AND PARTICIPANTS A multisite randomized controlled trial for prevention of depression among 176 nondepressed patients was conducted within 3 months following acute stroke from July 9, 2003, to October 1, 2007. The 12-month trial included 3 groups: a double-blind placebo-controlled comparison of escitalopram (n = 59) with placebo (n = 58), and a nonblinded problem-solving therapy group (n = 59). MAIN OUTCOME MEASURES The main outcome measure was the development of major or minor poststroke depression based on symptoms elicited by the Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition) (DSM-IV) and the diagnostic criteria from DSM-IV for depression due to stroke with major depressive-like episode or minor depression (ie, research criteria). RESULTS Patients who received placebo were significantly more likely to develop depression than individuals who received escitalopram (11 major and 2 minor cases of depression [22.4%] vs 3 major and 2 minor cases of depression [8.5%], adjusted hazard ratio [HR], 4.5; 95% confidence interval [CI], 2.4-8.2; P < .001) and also more likely than individuals who received problem-solving therapy (5 major and 2 minor cases of depression [11.9%], adjusted HR, 2.2; 95% CI, 1.4-3.5; P < .001). These results were adjusted for history of mood disorders and remained significant after considering possible confounders such as age, sex, treatment site, and severity of impairment in the model. Using an intention-to-treat conservative method of analyzing the data, which assumed that all 27 patients who did not start randomized treatment would have developed depression, and controlling for prior history of mood disorders, escitalopram was superior to placebo (23.1% vs 34.5%; adjusted HR, 2.2; 95% CI, 1.2-3.9; P = .007), while problem-solving therapy was not significantly better than placebo (30.5% vs 34.5%; adjusted HR, 1.1; 95% CI, 0.8-1.5; P = .51). Adverse events, including all-cause hospitalizations, nausea, and adverse effects associated with escitalopram were not significantly different between the 3 groups. CONCLUSIONS In this study of nondepressed patients with recent stroke, the use of escitalopram or problem-solving therapy resulted in a significantly lower incidence of depression over 12 months of treatment compared with placebo, but problem-solving therapy did not achieve significant results over placebo using the intention-to-treat conservative method of analysis. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00071643.

Improving primary care for depression in late life: the design of a multicenter randomized trial.

Background.Late life depression can be successfully treated with antidepressant medications or psychotherapy, but few depressed older adults receive effective treatment. Research Design. A randomized controlled trial of a disease management program for late life depression. Subjects.Approximately 1,750 older adults with major depression or dysthymia are recruited from seven national study sites. Intervention.Half of the subjects are randomly assigned to a collaborative care program where a depression clinical specialist supervised by a psychiatrist and a primary care expert supports the patient’s regular primary care provider to treat depression. Intervention services are provided for 12 months using antidepressant medications and Problem Solving Treatment in Primary Care according to a stepped care protocol that varies intervention intensity according to clinical needs. The other half of the subjects are assigned to care as usual. Evaluation.Subjects are independently assessed at baseline, 3 months, 6 months, 12 months, 18 months, and 24 months. The evaluation assesses the incremental cost-effectiveness of the intervention compared with care as usual. Specific outcomes examined include care for depression, depressive symptoms, health-related quality of life, satisfaction with depression care, health care costs, patient time costs, market and nonmarket productivity, and household income. Conclusions.The study blends methods from health services and clinical research in an effort to protect internal validity while maximizing the generalizability of results to diverse health care systems. We hope that this study will show the cost-effectiveness of a new model of care for late life depression that can be applied in a range of primary care settings.

Distress, psychiatric syndromes, and impairment of function in women with newly diagnosed breast cancer.

Emotional distress and psychiatric syndromes are prevalent in the breast cancer population at large. However, to date there is a paucity of literature specifically concerning presurgical breast cancer patients.

Development of a sleep diary for chronic pain patients

The present study examined the psychometric properties of the Daily Sleep Diary (DSD), an instrument developed for monitoring sleep among chronic pain patients. As part of a comprehensive evaluation, 46 chronic pain patients completed the DSD each morning. Items assessed the number of hours slept, length of sleep onset, frequency of awakenings during the night that resulted in trouble falling back to sleep, early morning awakening, quality of sleep, lack of restfulness, and the previous nights sleep compared to usual sleep. Reliability coefficients were significant. The sleep diary items significantly correlated with other retrospective measures of sleep. Duration of pain complaint was related to delayed sleep onset and lower quality of sleep. Pain severity was related to fewer hours slept and delayed sleep onset. The DSD items correlated with measures of both depression and anxiety. The results emphasize the importance of including sleep in both assessment and treatment of chronic pain patients.

Anxiety and depression in patients receiving implanted cardioverter-defibrillators : A longitudinal investigation

Objective: The implantable cardioverter-defibrillator (ICD) has dramatically improved survival rates following sudden cardiac death episodes. However, researchers have devoted little attention to the psychosocial consequences of living with the device. The current study used a longitudinal design to evaluate the impact of adaptation to the ICD on incidence and severity of anxiety and depression. Method: ICD recipients were administered standardized anxiety and depression questionnaires as well as questions evaluating quality of life related to the ICD in two consecutive yearly assessments. A preliminary evaluation of potentially important theoretical variables, such as the perceived predictability and controllability of shock onset was also conducted. Results: One-third of the study population (N = 38) had clinically significant levels of anxiety, depressed mood, and fear of symptoms of autonomic arousal. These negative affective states persisted over time, with 40 to 63 percent of subjects continuing to have ongoing difficulties over a one-year time period. Anxiety about the ICD firing was closely associated with the occurrence of depression, while avoidance of activities was associated with anxiety. “Worry” about the ICD and a belief that ICD firing can be predicted were associated with anxiety sensitivity. Conclusions: Depressive and anxiety states in ICD recipients may be frequent, clinically significant, and resistant to spontaneous resolution. Early signs of anxiety and depression in ICD recipients should be evaluated. Implications for future research are discussed.

Health functioning impairments associated with posttraumatic stress disorder, anxiety disorders, and depression.

Although anxiety disorders have been associated with impairments in self-reported health functioning, the relative effect of various anxiety disorders has not been studied. We compared health functioning of patients with a principal diagnosis of posttraumatic stress disorder (PTSD), panic disorder (PD), generalized anxiety disorder (GAD), and major depressive disorder (MDD). Patients with PTSD and MDD were equally impaired on overall mental health functioning, and both were significantly worse than patients with PD and GAD. PTSD was associated with significantly worse physical health functioning relative to PD, GAD, and MDD. Hierarchical regression showed that the association of PTSD with physical health functioning was unique and was not caused by the effects of age, depression, or comorbid anxiety disorders. Both PTSD and comorbid anxiety accounted for unique variance in mental functioning. These results highlight the association of PTSD with impaired physical and mental functioning and suggest that effective treatment of PTSD may affect overall health.

Impact of Comorbid Panic and Posttraumatic Stress Disorder on Outcomes of Collaborative Care for Late-Life Depression in Primary Care

OBJECTIVE Comorbid anxiety disorders may result in worse depression treatment outcomes. The authors evaluated the effect of comorbid panic disorder and posttraumatic stress disorder (PTSD) on response to a collaborative-care intervention for late-life depression in primary care. METHODS A total of 1,801 older adults with depression were randomized to a collaborative-care depression treatment model versus usual care and assessed at baseline, 3, 6, and 12 months, comparing differences among participants with comorbid panic disorder (N=262) and PTSD (N=191) and those without such comorbid anxiety disorders. RESULTS At baseline, patients with comorbid anxiety reported higher levels of psychiatric and medical illness, greater functional impairment, and lower quality of life. Participants without comorbid anxiety who received collaborative care had early and lasting improvements in depression compared with those in usual care. Participants with comorbid panic disorder showed similar outcomes, whereas those with comorbid PTSD showed a more delayed response, requiring 12 months of intervention to show a significant effect. At 12 months, however, outcomes were comparable. Interactions of intervention status by comorbid PTSD or panic disorder were not statistically significant, suggesting that the collaborative-care model performed significantly better than usual care in depressed older adults both with and without comorbid anxiety. CONCLUSIONS Collaborative care is more effective than usual care for depressed older adults with and without comorbid panic disorder and PTSD, although a sustained treatment response was slower to emerge for participants with PTSD. Intensive and prolonged follow-up may be needed for depressed older adults with comorbid PTSD.

Assessment of chronic pain patients with the MMPI-2: By Laura S. Keller and James N. Butcher Published by University of Minnesota Press, Minneapolis, Minnesota 1991, 362 pages,

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The Functional Assessment of Chronic Illness Therapy (FACIT) system provides a general, multidimensional measure of health-related quality of life (FACT-G) that can be augmented with disease or symptom-specific subscales. The 19-item palliative care subscale of the FACIT system has undergone little psychometric evaluation to date. The aim of this paper is to report the internal consistency, factor structure, and construct validity of the instrument using the palliative care subscale (FACIT-Pal). Two hundred fifty-six persons with advanced cancer in a randomized trial testing a palliative care psychoeducational intervention completed the 46-item FACIT-Pal at baseline. Internal consistency was greater than 0.74 for all subscales and the total score. Seventeen of the 19 palliative care subscale items loaded onto the four-factor solution of the established core measure (FACT-G). As hypothesized, total scores were correlated with measures of symptom intensity (r=-0.73, P<0.001) and depression (r=-0.75, P<0.001). The FACIT-Pal was able to discriminate between participants who died within three months of completing the baseline and participants who lived for at least one year after completing the baseline assessment (t=-4.05, P<0.001). The functional well-being subscale discriminated between participants who had a Karnofsky performance score of 70 and below and participants with a Karnofsky performance score of 80 and above (t=3.40, P<0.001). The findings support the internal consistency reliability and validity of the FACIT-Pal as a measure of health-related quality of life for persons with advanced cancer.