Data collection occurred between December 8, 2011 and April 30, 2014. We collected baseline patient characteristics, including age, sex, race, education level, cancer diagnosis, CAGE questionnaire [15 (link)] and MDAS [16 (link)] during the first study visit. For the purpose of this study, we considered all Brazilians and Chileans to be of Hispanic ethnicity. We also assessed ESAS and Karnofsky performance status during both the first and second visits, and Patient's Global Impression Scale (PGI) at the second visit. The site principal investigators all visited Houston to learn about the study procedures. To ensure data is collected in an accurate fashion, the study PI had regular teleconference with the research team at each site 1-2 times per month to provide training and longitudinal monitoring.
ESAS assesses the average intensity of 10 symptoms (pain, fatigue, nausea, depression, anxiety, drowsiness, shortness of breath, appetite, feelings of well-being and sleep) over the past 24 hours, each with an 11-point numerical rating scale that ranges from 0 (no symptom) to 10 (worst intensity) [3 (link)]. It has been translated into the languages in respective countries and by MAPI Research trust (i.e. English, Arabic, Portugese, Spanish, Korean and Hindi) and validated both linguistically and psychometrically [5 (link), 8 (link), 11 (link), 17 (link), 18 (link)].
PGI is a validated global rating of change scale used to evaluate subjective patients’ response at the second visit [19 (link), 20 (link)]. Patients were asked to answer the question for each of the 10 ESAS symptoms: “How is your symptom over the last 24 hours compared to your last visit?” for each of the 10 ESAS symptoms (“better”, “about the same”, “worse”). If the patient answered “better”, they were asked “how much better?” (“much better”, “better”, “a little better”). Alternatively, if the patient answered “worse”, they were asked “how much worse?” (“much worse”, “worse”, “a little worse”). PGI has been commonly used as a secondary outcome in a large number of pain studies and also used in several studies as an anchor for establishing clinical importance levels [21 (link), 22 (link)].
ESAS assesses the average intensity of 10 symptoms (pain, fatigue, nausea, depression, anxiety, drowsiness, shortness of breath, appetite, feelings of well-being and sleep) over the past 24 hours, each with an 11-point numerical rating scale that ranges from 0 (no symptom) to 10 (worst intensity) [3 (link)]. It has been translated into the languages in respective countries and by MAPI Research trust (i.e. English, Arabic, Portugese, Spanish, Korean and Hindi) and validated both linguistically and psychometrically [5 (link), 8 (link), 11 (link), 17 (link), 18 (link)].
PGI is a validated global rating of change scale used to evaluate subjective patients’ response at the second visit [19 (link), 20 (link)]. Patients were asked to answer the question for each of the 10 ESAS symptoms: “How is your symptom over the last 24 hours compared to your last visit?” for each of the 10 ESAS symptoms (“better”, “about the same”, “worse”). If the patient answered “better”, they were asked “how much better?” (“much better”, “better”, “a little better”). Alternatively, if the patient answered “worse”, they were asked “how much worse?” (“much worse”, “worse”, “a little worse”). PGI has been commonly used as a secondary outcome in a large number of pain studies and also used in several studies as an anchor for establishing clinical importance levels [21 (link), 22 (link)].
