Grutsch et al. BMC Cancer 2011, 11:193 http://www.biomedcentral.com/1471-2407/11/193 Table 1 Distribution of patient demographic and clinical variables by site Demographic/Clinicala Inpatients (n = 42) Outpatients (n = 42) Age in years (Mean; Range) Sex (M:F) Cancer Stage (IIIA&B: IV) Prior Therapy (Yes:No) WHO ECOG (0:1:2) COPD (No:Mild:Mod:Severe)c 57 (40-78)* 23:19* 10:32 21:20d* 17:18:07 66 (47-94) 42:0 9:33 10:32 13:24:04d 14:7:13:8 Page 4 of 13 Site Difference (c2, p)b 4.0, < 0.01c 24.6, < 0.01 2.1, 0.36 6.7, 0.01 2.2, 0.33 aValues are numbers of patients except for Age. bBased on chi-square test. cBased on t-test. dOne patient at MRMC lacked documentation of prior therapy, while another patient at VAMC lacked documentation on ECOG scale. *Significant difference at p < 0.05 compared to outpatients. inpatients had Stage IV disease (74.4%) than outpatients (47.6%). 50% and 26% of inpatients and outpatients, respec- tively, were experiencing recurrence of disease after first line systemic treatment failure. The median time between terminating first line therapy and the adminis- tration of actigraphy in the ten outpatients was 51.6 months (range 7.9 to 78 months), but for inpatients it was 3.5 months (0.8 to 33.5 months). Assessment of Patient Evaluability Although all patients agreed to wear the actigraphs, twelve actigraphs were worn for less than 48 hours and/ or had frequent missing observations due to instrument malfunction. Four patients failed to respond fully to the questionnaires, so we have full actigraphy and full ques- tionnaire data for 68 of these 84 patients. Quality of Life Both inpatients and outpatients reported lower scores for all EORTC-QLQ-C30 functional domains when compared to population-based controls (Table 2). The differences in domain scores between these lung cancer patients and population-based controls were large, ran- ging from 16 to nearly 30 points. Both inpatients and outpatients reported scores that were 20 to 30 points higher (worse) than the population based controls in the symptom items of fatigue, loss of appetite, insomnia, and pain. Our advanced lung cancer patients, as expected, also scored 10 to 20 points higher (worse) on these symptom items than the EORTC reference popu- lation of newly diagnosed lung cancer patients with stage III and IV disease. Despite various demographic and clinical differences between inpatients and outpati- ents, only two of 20 symptom categories, fatigue (p = Table 2 Distribution of EORTC QLQ-C30 domain and symptom item scales by site Domain Study Population (mean ± se) All Patients Inpatients Outpatients General Populationc (mean) Reference Populationd [mean (SD)] Global Scorea 50.78 ± 3.15 Functional Scalesa Physical 64.53 ± 3.15 Role 54.44 ± 4.28 Emotional 59.52 ± 3.31 Cognitive 70.22 ± 3.18 Social 55.33 ± 3.77 Symptom Scalesb Fatigue 52.00 ± 3.55 Nausea 15.78 ± 2.53 Pain 53.33 ± 4.38 Single Itemsb Dyspnoea 46.22 ± 3.79 Insomnia 44.00 ± 3.91 Appetite Loss 39.11 ± 3.97 Constipation 29.33 ± 3.90 Diarrhea 7.11 ± 2.03 49.80 ± 4.84 51.96 ± 3.86 73.33 ± 4.22* 60.57 ± 6.01 59.96 ± 4.24 76.02 ± 4.15 51.22 ± 5.35 45.26 ± 4.63* 14.63 ± 3.30 48.37 ± 6.10 36.58 ± 4.33* 39.84 ± 4.97 33.33 ± 4.94 26.83 ± 4.83 5.69 ± 2.83 53.92 ± 4.12* 47.06 ± 5.91 58.99 ± 5.29 63.24 ± 4.71 60.29 ± 5.22 60.29 ± 5.22* 17.16 ± 3.95 59.31 ± 6.22 57.84 ± 6.02* 49.02 ± 6.17 46.08 ± 6.30 32.35 ± 6.37 8.82 ± 2.92 - 89.9 83.3 82.8 86.5 85.8 28.8 4 20.5 14.3 20.4 7.5 10.4 9.4 54.7 (23.8) 65.9 (25.6) 55.5 (34.5) 67.3 (24.1) 81.6 (22.7) 69.8 (30.3) 44.2 (27.5) 10.8 (19.1) 34.7 (32.3) 40.7 (32.2) 34.8 (33.4) 31.1 (34.6) 22.2 (31.7) 7.3 (18.1) aHigher scores indicate better daily function, thus better quality of life. bLower scores indicate fewer symptoms, thus better quality of life. cEORTC general population of 1,965 randomly selected subjects ages 18 to 93 years (Hjermstad, et. al. J Clin Oncol 1998)., dEORTC reference population of 1,313 lung cancer patients with stage III and IV disease (Scott, et. al. EORTC Reference Manual 2008). *Inpatients versus Outpatients are significantly different, p < 0.05.