Changes In Symptom Burden Research Articles

Longitudinal validation of a modified Edmonton symptom assessment system (ESAS) in haemodialysis patients

Health-related quality of life (HRQL) is an important outcome in the treatment of end-stage renal disease (ESRD) and appears to be highly associated with patient self-report of symptom burden. This study examines the longitudinal validity of the modified Edmonton symptom assessment system (ESAS) to determine the impact of change in symptom burden on the change in HRQL of haemodialysis (HD) patients. 261 haemodialysis patients completed the Kidney Disease Quality of Life-Short Form (KDQOL-SF) and the ESAS at baseline and at 6 months. The change in overall symptom distress score was strongly correlated with the change in KDQOL-SF subscales symptom/problem list (R=-0.73, P<0.01), effects of kidney disease (R=-0.53, P<0.01), and burden of kidney disease (R=-0.46, P<0.01) as well as overall physical health composite (R=-0.58, P<0.01) and overall mental health composite (R=-0.68, P<0.01). The change in symptom burden, as described by the ESAS, accounted for 46% of the change in the mental HRQL and 34% of the change in the physical HRQL. There was no correlation between baseline demographics, comorbidity or changes in biochemical markers with changes in either the ESAS or HRQL scores. The modified ESAS is a simple, valid tool for the longitudinal assessment of physical and psychological symptom burden in ESRD and is responsive to change in HD patients. The use of this symptom assessment scale and improved management of patient symptoms would be expected to positively impact HD patients' HRQL.

Symptom Assessment in Patients with Chronic Lymphocytic Leukemia: Validation and Application of the M.D. Anderson Symptom Inventory.

CLL is the most prevalent form of adult leukemia. The life expectancy of patients affected by CLL varies significantly, with a large fraction of patients with survival expectation of 10 years or longer. Furthermore a number of patients are observed without treatment intervention. These patients have been labeled as “asymptomatic” and very little attention has been placed to the symptom burden that accompanies CLL. In order to measure the quality of life of patients with CLL, we explored the reliability and validity of the M. D. Anderson Symptom Inventory (MDASI). We enrolled 99 consecutive patients followed at our outpatient center. To assess and construct validity, we performed principal axis factor analysis with oblimin rotation. To assess reliability, we calculated separate coefficient alphas for the severity and interference subscale items. Patients were 63% male with a mean age of 59 years (range 29–79), with 43% age 60 years or older. 94% were White Non-Hispanic patients. 61% were employed. 83% had higher than high school education. 75% had Rai staging 0–1, and 53% had received prior treatment. Factor analysis of the MDASI items resulted in a two-factor solution (symptom severity and interferences) that satisfied criteria for interpretability and model fit in a confirmatory setting. Cronbach coefficient alphas for the MDASI were 0.91 for severity and 0.96 for interference. We also examined the criterion validity of the two MDASI subscales by investigating their correlation to similar subscales of the SF-12. MDASI “worst pain” was highly correlated with the “body pain” subscale of the SF-12 (r=−.84, p=.000). MDASI “fatigue” was significantly correlated with the SF-12 “energy” item (r=.79, p=.000). The patient self reported most severe symptoms were fatigue, sleeping disturbance, drowsiness, distress, and shortness of breath. There were no significant differences of symptom severity by age group (more or less than 60 years old) and by staging (Rai 0–1, 2–3). However, fatigue severity was significantly higher in patients who had more than 2 therapies than patients without prior therapy (4.26 vs 2.07 on 0 to 10 fatigue scale on MDASI, P=.003). The most burdensome symptoms were interference of working, activity and enjoyment of life. Moderate to severe symptoms that would be the targeted area of symptom control in CLL patients were fatigue (25%), drowsness, (13%), shortness of breath (11%), and sleeping disturbance (12%). In conclusion this preliminary data analysis showed that the MDASI is a reliable and valid tool for assessing symptom severity and interference with daily functioning in CLL patients. This versatile assessment tool can be used to measure CLL-related symptom burden in the clinical practice of symptom management as well as to measure changes in symptom burden in patients enrolled in therapeutic clinical trials.

Using the MD Anderson Symptom Inventory (MDASI) to assess symptom burden and interference: Interim results of an open-label study of darbepoetin Alfa 200 mcg every 2 weeks (Q2W) for the treatment of chemotherapy-induced anemia (CIA)

8065 Background: Cancer patients (pts) receiving chemotherapy experience symptoms related to both their disease and its treatment, including CIA. The MDASI is a list of 19 questions that focus on both core symptoms and symptom interference with life activities (Cleeland et al, 2000). Methods: This fully enrolled, ongoing, 26 week, multicenter, open-label, community-based study (N = 2423) was designed to prospectively assess the relationship between hemoglobin (Hb) and changes in symptom burden in pts with CIA receiving darbepoetin alfa (DA). Eligibility criteria included concurrent multicycle chemotherapy for nonmyeloid malignancies and Hb ≤11 g/dL. DA was administered at 200 mcg Q2W. Hb was measured Q2W and the MDASI administered weekly. This interim analysis includes data through week 17 for 1053 pts who completed 16 weeks of study treatment. Results: The mean (SD) baseline (BL) Hb was 10.1 (0.8) g/dL. The Kaplan-Meier percentage (95% CL) of pts with a hematopoietic response was 72% (70, 74) after 16 weeks. Exploratory analyses of the MDASI items have been performed and indicate the impact of treatment on the severity of symptoms. For example, the percent of pts with MDASI scores indicating moderate to severe symptom burden (score ≥ 4 where 10 = maximum burden) at baseline and after 16 weeks are presented (Table). Conclusion: DA treatment is associated with significant improvement in a breadth of symptoms for pts with moderate to severe burden as measured by the MDASI. This study provides additional support that DA 200 mcg Q2W is both well tolerated and efficacious in improving symptoms in pts with CIA. Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Amgen Amgen; Merck Amgen Amgen Amgen

Using the MD Anderson Symptom Inventory (MDASI) to assess symptom burden and interference: Interim results of an open-label study of darbepoetin Alfa 200 mcg every 2 weeks (Q2W) for the treatment of chemotherapy-induced anemia (CIA)

8065 Background: Cancer patients (pts) receiving chemotherapy experience symptoms related to both their disease and its treatment, including CIA. The MDASI is a list of 19 questions that focus on both core symptoms and symptom interference with life activities (Cleeland et al, 2000). Methods: This fully enrolled, ongoing, 26 week, multicenter, open-label, community-based study (N = 2423) was designed to prospectively assess the relationship between hemoglobin (Hb) and changes in symptom burden in pts with CIA receiving darbepoetin alfa (DA). Eligibility criteria included concurrent multicycle chemotherapy for nonmyeloid malignancies and Hb ≤11 g/dL. DA was administered at 200 mcg Q2W. Hb was measured Q2W and the MDASI administered weekly. This interim analysis includes data through week 17 for 1053 pts who completed 16 weeks of study treatment. Results: The mean (SD) baseline (BL) Hb was 10.1 (0.8) g/dL. The Kaplan-Meier percentage (95% CL) of pts with a hematopoietic response was 72% (70, 74) after 16 weeks. Exploratory analyses of the MDASI items have been performed and indicate the impact of treatment on the severity of symptoms. For example, the percent of pts with MDASI scores indicating moderate to severe symptom burden (score ≥ 4 where 10 = maximum burden) at baseline and after 16 weeks are presented (Table). Conclusion: DA treatment is associated with significant improvement in a breadth of symptoms for pts with moderate to severe burden as measured by the MDASI. This study provides additional support that DA 200 mcg Q2W is both well tolerated and efficacious in improving symptoms in pts with CIA. Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Amgen Amgen; Merck Amgen Amgen Amgen

“Coping with depression”: an open study of the efficacy of a group psychoeducational intervention in chronic, treatment-refractory depression

Background: Failure to respond to antidepressant medication represents a major clinical problem. Few therapeutic interventions have been shown to benefit such individuals. Method: Patients attended a 12-session psychoeducational programme over a period of 10 weeks, with follow-up at 26 weeks. The main outcome measures were the self-report Beck Depression Inventory (BDI-II), the Global Severity Index (GSI) of the Brief Symptom Inventory (BSI) and the EuroQol 5D. Results: Baseline assessments confirmed substantial chronicity and treatment resistance, high symptom burden and poor quality of life in the study cohort. Twenty-six week follow-up data were obtained from 34% of cohort. Completion of the course was associated with clinically significant changes in symptom burden. Sustained remission was achieved by 35% of completers. Limitations: We did not characterise the cohort using structured clinical interview and did not collect structured, objective ratings of mental health status. There was no control group. There was a high attrition rate and caution must be exercised in interpreting results. Conclusions: For a proportion of patients with chronic depressive episodes that have not responded to antidepressant treatments, the “Coping with Depression” psychoeducational group may confer sustained and meaningful benefit. Controlled studies are warranted.