The anemia impact measure (AIM): development and content validation of a patient-reported outcome measure of anemia symptoms and symptom impacts in cancer patients receiving chemotherapy.

PURPOSE: To develop a patient-reported outcome instrument for measuring anemia symptoms and their impact in patients with chemotherapy-induced anemia (CIA). METHODS: Qualitative research was conducted using six focus groups and 24 interviews with 46 CIA patients, eight interviews in patients receiving chemotherapy with no CIA history and two interviews in patients successfully treated for CIA. Atlas.ti 5.0 was used to organize key concepts. Cognitive interviews with 16 CIA patients and assessment of relevance of each item to CIA by 10 clinicians were also conducted to evaluate content validity. RESULTS: Most CIA patients were white (76%) and female (83%), and the average age was 60 years. The most common cancer types were breast cancer (54%) and lung cancer (17%). Tiredness was the most prevalent symptom and rated as the most important by 83% of CIA patients; weakness, shortness of breath, lightheadedness, and dizziness were ranked next in importance. The final anemia impact measure (AIM) contains: (1) daily CIA symptom diary (9 items), and (2) impact of CIA-related tiredness (29 items covering daily living activities, social activities, cognitive function, and emotions). Cognitive interviews found that the AIM was relevant and easy to understand. CONCLUSIONS: The AIM assesses important patient-perceived CIA symptoms and their impact and was developed using extensive patient qualitative data.

Humanistic and economic burden of generalized anxiety disorder in North America and Europe.

BACKGROUND: To review the humanistic and economic burden of generalized anxiety disorder (GAD). METHODS: MEDLINE, EMBASE and the Cochrane Library, limited to articles published in English, between 1987 and 2010, in North America, Europe and Australia. The key focus was humanistic or functional outcomes, cost of illness and economic outcomes. Ninety articles fitting criteria on (a) GAD study population, (b) United States, Europe or Australia, and (c) humanistic burden or economic burden were reviewed. Methods and findings were summarized by two researchers; inconsistencies were resolved by a third reviewer. RESULTS: GAD was associated with increased impairments in psychosocial functioning, role functioning, work productivity and health-related quality of life (HRQL). The HRQL impairments were comparable with those associated with depression or panic disorder. Patients with GAD and co-morbid depression reported significantly greater impairment in HRQL than did those with either disorder alone. GAD patients had significantly higher median medical costs than primary care patients without GAD (US $2375 versus $1448). The mean annual medical cost of GAD was $2138 higher than for other anxiety disorders (mean $6475). Finally, GAD was frequently under-recognized in primary care, and available studies reported that only 20% to 32% of patients were adequately treated. LIMITATIONS: The review was limited to pharmacologic treatments for GAD and to publications in English. CONCLUSIONS: GAD is associated with significant burden on patient functioning and well-being, leading to increased health care utilization and medical costs. Patients with GAD are often suboptimally treated, which adds to the HRQL burden of this disorder.

Reduction in opioid-related adverse events and improvement in function with parecoxib followed by valdecoxib treatment after non-cardiac surgery: a randomized, double-blind, placebo-controlled, parallel-group trial.

BACKGROUND: Multimodal pain therapy including cyclo-oxygenase-2 inhibitors can result in optimal pain management with decreased opioid use and fewer opioid-related adverse events. Patient reported outcomes (PROs) help identify benefits in reduced opioid use and increased pain control. METHODS: In this randomized, double-blind trial, patients (n = 1062) undergoing major non-cardiac elective surgery received either parenteral parecoxib for 3 days or placebo then oral valdecoxib or placebo for a total of 10 days, with both arms being allowed additional opioid analgesia. Clinically meaningful opioid-related adverse events were assessed daily using the Opioid-Related Symptom Distress Scale (OR-SDS). Pain severity and interference with function were evaluated daily using the modified Brief Pain Inventory exploratory form (mBPI-e). Additional validation work was undertaken to understand the psychometric properties of the two PROs. Detailed clinical results were reported elsewhere. RESULTS: Patients receiving parecoxib/valdecoxib achieved significantly better pain control and consumed 37% and 28% less opioid medication than the placebo group on day 2 and day 3, respectively. Over the 10-day treatment period, patients receiving parecoxib/valdecoxib consumed 31% less opioid medication. This coincided with significantly fewer (p < 0.0001) OR-SDS clinically meaningful events (CMEs) and lower mBPI-e scores from days 2-10 in the parecoxib/valdecoxib group compared with the placebo group. On day 3, the percentage of patients reporting one, two or three CMEs in the parecoxib/valdecoxib versus placebo group was 11.6% versus 13.0%, 2.3% versus 5.1%, and 0.8% versus 2.3%, respectively. The mean (+/- standard error) mBPI-e pain severity scores over days 2-10 were 2.47 +/- 0.04 for the parecoxib/valdecoxib group and 3.01 +/- 0.04 for the placebo group, and the mean mBPI-e pain interference scores were 1.73 +/- 0.04 and 2.19 +/- 0.04, respectively. CONCLUSIONS: Patients receiving parecoxib/valdecoxib had less pain interference on physical functioning, required less opioid medication and experienced fewer clinically meaningful opioid-related adverse events than patients receiving placebo.