OBJECTIVE: Among sepsis survivors, during recovery and thereafter, it is not established if patients resume or improve their quality of life. The study objective was to assess change in health status among sepsis survivors over a 6‐month period. METHODS: This was a prospective, multicenter, cohort study involving 701 patients with severe sepsis of presumed infectious origin from 53 hospitals. Patients' health status was assessed at day 30, 60, 90 and180 using EuroQoL‐5D and a visual analog scale. Instruments were completed by the patient while in hospital and follow‐up assessments were performed by telephone interview. RESULTS: For this interim analysis, 93 patients had completed health state information for day 30, 60, 90, and 180. Mean (SD) age was 60 + 17 years and 48% were female. The number of patients remaining in the hospital decreased from 56% at day 30 to 7%, thereafter. The average utility score/VAS score at each time point was: 0.53/0.61 (day 30), 0.62/0.68 (day 60), 0.68/0.71 (day 90), 0.69 (p < 0.0001)/0.72 (day 180). Based on patients' subjective assessment of their health status during the last 12 months, 60% had improved or maintained their health. The improvement in utility scores was influenced primarily by changes in mobility, self‐care, and usual activities. Pain and anxiety appeared to have a minimal influence on overall improvement in health status. At day 30, 28% of the patients reported no problems in walking, compared to 58% at day 180. Likewise, 48% and 26% of patients reported no problems with self‐care and performing usual activities at day 30, respectively, and 67% (self‐care) and 47% (usual activities) at day 180. CONCLUSION: Sepsis survivors experienced a continual improvement towards population‐based normal levels in their health utility scores over a 6‐month period. Improvements in physical activity, self‐care and usual activities were predominantly associated with improved health utility.
BACKGROUND: Rheumatoid arthritis (RA) leads to physical and psychosocial functional disabilities affecting productivity of patients in their daily activities. OBJECTIVE: to evaluate the impact of early RA on productivity. METHODS: Baseline data was analyzed from the Study of New Onset Rheumatoid Arthritis (S.O.N.O.R.A.SM), a five‐year prospective, longitudinal, inception‐cohort study to document long‐term functional, clinical, and humanistic outcomes and patterns of treatment in patients with new onset RA. Telephone interviews were performed by trained interviewers to collect data on employment status, annual household income (AHI) and productivity at work and normal activities, outside of paid job (NAOPJ), including absenteeism over the past 4 months, reason for absenteeism, and effectiveness at work and NAOPJ when working with arthritis symptoms (AS). RESULTS: One hundred thirty one patients completed the baseline survey. Mean age was 56 ± 15 years; 78% were female; 82% were Caucasian. Employment status reported was full‐time (52%), part‐time (2%), retired (26%), and other (20%). AHI were <$50,000 (63%), $50,000–74,999 (17%),> $75,000 (18%), and 2% refused to provide AHI. Ninety‐one percent of patients were employed at a paid job. The mean absenteeism at work and NAOPJ were 4.3 days (SE = 1.1) and 25.9 days (SE = 3.3), respectively. Of the participants reporting absenteeism, 40% and 69% reported that the majority of absenteeism was due to AS for work and NAOPJ, respectively. Compared to their normal performance, patients were 78% and 64% as effective when working with AS at work and NAOPJ, respectively. CONCLUSION: Despite new onset of RA in this population, negative impact on productivity was observed. A greater decline in productivity was reported for NAOPJ. This may imply that NAOPJ is compromised before work activities in early RA patients. Five‐year follow‐up of this population will provide further insight on productivity changes and the economic burden associated with progressive disease.
OBJECTIVE: The importance of assessing fatigue in rheumatoid arthritis (RA) has been confirmed in numerous studies. Several instruments are available to assess fatigue, however, the psychometric properties of most have been determined in various populations other than RA and the instruments tend to measure different aspects of fatigue. The objective of this study was to assess the performance of two fatigue instruments, one was developed in the RA population and the other in a nondisease‐specific population. METHODS: This study is an ongoing prospective, multi‐center, observational study conducted to document long‐term functional, clinical, humanistic and economic outcomes, and treatment patterns in patients with new onset rheumatoid arthritis. Two fatigue instruments were used to assess RA patients: The Functional Assessment of Chronic Illness Therapy‐Fatigue Subscale (FACIT‐F), an instrument used primarily in oncology populations, and the Multidimensional Assessment of Fatigue (MAF), developed in an RA population. MAF measures four dimensions of fatigue (severity, distress, degree of interference in daily activities, and timing). At baseline, patients were requested to complete both the 16‐item, MAF and the 13‐item, FACT‐F via telephone interview. Using baseline data only, the correlation between the MAF and the FACIT‐F was tested in 133 patients with early RA (signs and symptoms> 3 months and <12 months). RESULTS: Patients mean + SD age was 55 + 15 years and 77% were female. Mean + SD MAF score was 23.3 + 12.3 with a normal range of 1(no fatigue)–50(fatigue). Mean FACIT‐F score was 33.2 + 9.3 with a normal range of 52 (no fatigue)–0 (fatigue). The aggregate scores for each instrument were highly correlated with a Pearson's coefficient of −0.81 (p < 0.001). CONCLUSION: Based on this analysis, it appears that the FACIT‐F has validity for use in the early RA population. However, as follow‐up assessments are completed, a more detailed analysis may reveal additional psychometric properties of the instrument in the early RA population and with disease progression.
BACKGROUND: Health‐related quality of life (HR‐QOL) measures have been used to study the impact of disease activity in patients with rheumatoid arthritis (RA). The objective of this study was to evaluate the correlation between SF‐36 scales, physical function (PF), role physical (RP) and bodily pain (BP) and Rapid Assessment of Disease Activity in Rheumatology (RADAR). METHODS: Baseline data was analyzed from the Study of New Onset Rheumatoid Arthritis (S.O.N.O.R.A.SM), a 5‐year prospective, longitudinal, inception cohort study to document long‐term functional, clinical, and humanistic outcomes and patterns of treatment in patients with new onset rheumatoid arthritis. Baseline data collection consisted of RADAR and SF‐36 via telephone interviews by trained interviewers. To assess the correlation, Pearson product moment correlation coefficients were calculated. RESULTS: One hundred thirty‐one patients completed the baseline survey. Mean age of the sample was 56 years; 78% were female; 82% were Caucasian. SF‐36's PF, RP, and BP scales had means of 54 (SE = 0.02), 31 (SE = 0.03), and 47 (SE = 0.02), respectively. Mean scores for RADAR items were 7.2 (SE = 0.22) for “arthritis activity over the past 6 months (AA6M)”, 4.9 (SE = 0.23) for “arthritis activity today (AAT)”, 4.2 (SE = 0.22) for “arthritis pain today (APT)”, and 2.6 (SE = 0.15) for “morning stiffness today (MST)”. SF‐36's PF scale correlated with AA6M (r = 0.39, p < 0.001), AAT (r = 0.49, p < 0.001), APT (r = 0.51, p < 0.001), and MST (r = 0.40, p < 0.001). SF‐36's RP scale correlated with AA6M (r = 0.37, p < 0.001), AAT (r = 0.38, p < 0.001), APT (r = 0.44, p < 0.001), and MST (r = 0.33, p < 0.001). SF‐36's BP scale correlated with AA6M (r = 0.50, p < 0.001), AAT (r = 0.48, p < 0.001), APT (r = 0.59, p < 0.001), and MST (r = 0.42, p < 0.001). CONCLUSION: The SF‐36's BP domain resulted in the highest correlation with RADAR items. The APT item of RADAR had the highest correlation with all three domains of SF‐36. These results suggest that the level of bodily pain is indicative of functioning and well‐being of patients.
BACKGROUND: Both physician‐assessed and patient self‐reported joint counts have been used in the assessment of disease activity in rheumatoid arthritis. The objective of this study was to compare patient vs. physician reported joint counts in patients with new onset RA. METHODS: Baseline data was analyzed from the Study of New Onset Rheumatoid Arthritis (S.O.N.O.R.A.SM), a five‐year prospective, longitudinal, inception cohort study to document long‐term functional, clinical, and humanistic outcomes and patterns of treatment in patients with new onset RA. Baseline data collection consisted of physician and patient surveys. Physicians assessed swollen (SJ) and tender/painful joints (TJ) while patients reported painful joint (PJ). Physician's SJ and TJ consisted of examination in 64 and 66 joints, respectively. Patient's PJ was assessed in 16 joint areas with use of a mannequin. The Pearson product moment correlation coefficient was calculated for SJ, TJ, and PJ counts. RESULTS: One hundred and seven patients completed the baseline survey. Mean age of the sample was 55 ± 15 years; 79% were female; 80% were Caucasian. Mean joint counts were 12.6 (SE = 0.9) SJ, 14.0 (SE = 1.3) TJ, and 6.6 (SE = 0.4) PJ. Patient‐reported PJ correlated with physician‐reported SJ (r = 0.22, p = 0.023) and TJ (r = 0.55, p < 0.001). CONCLUSION: Higher correlation was observed between PJ and TJ compared to SJ. Patient, self‐reported joint counts may be a useful surrogate of joint activity in the absence of physician assessment. However, caution should be taken given that the accuracy of patient, self‐reported joint counts still needs further evaluation. Five‐year follow‐up of this population will provide further insight on the sensitivity to change for both patient and physician reported joint counts as it relates to disease activity.
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