Date Published: February 31, 2012
Publisher: Informa Healthcare
Author(s): André Maier, Teresa Holm, Paul Wicks, Laura Steinfurth, Peter Linke, Christoph Münch, Robert Meyer, Thomas Meyer.
Self-assessment of symptom progression in chronic diseases is of increasing importance in clinical research, patient management and specialized outpatient care. Against this background, we developed a secure internet platform (ALShome.de) that allows online assessment of the revised ALS Functional Rating Scale (ALSFRS-R) and other established self-assessment questionnaires. We developed a secure and closed internet portal to assess patient reported outcomes. In a prospective, controlled and stratified study, patients conducted a web-based self-assessment of ALSFRS-R compared to on-site assessment. On-site and online assessments were compared at baseline (n = 127) and after 3.5 months (n = 81, 64%). Results showed that correlation between on-site evaluation and online testing of ALSFRS-R was highly significant (r = 0.96; p < 0.001). The agreement of both capturing methods (online vs. on-site) was excellent (mean interval, 8.8 days). The adherence to online rating was high; 75% of patients tested on-site completed a follow-up online visit (mean 3.5 months, SD 1.7). We conclude that online self-assessment of ALS severity complements the well-established face-to-face application of the ALSFRS-R during on-site visits. The results of our study support the use of online administration of ALSFRS-R within clinical trials and for managing the care of ALS patients.
The ALS Functional Rating Scale (ALSFRS) is a validated, clinician-administered instrument for assessment in the domains of gross and fine motor function, bulbar symptoms and breathing ability in patients with ALS (1). The score reflects deterioration of function in the natural course of ALS but may have lower sensitivity in advanced disease stages (2,3). The scale was developed primarily to assess outcomes in pharmaceutical clinical trials and does not rely upon physical examinations or instruments (1,4). An initial imbalance within the scale that minimized the importance of respiratory function was rectified by a revision (ALS Functioning Rating Scale, revised (ALSFRS-R)) to incorporate respiratory symptoms and the need for ventilation (5). When administered as an interview, the ALSFRS-R shows a high inter-rater and intra-rater reliability (6,7) and can be reliably administered over the telephone (7-9).
One hundred and twenty-seven patients (described in Table I) met the conditions for statistical analysis according to study protocol. The mean ALSFRS-R on-site at baseline was 33.6 (SD 9.1) compared to 33.8 (SD 9.1) online. The mean loss of the ALS FRS-R value per month (modified delta ALSFRS-R: 48 – ALSFRS-R at ‘time of inclusion’/duration from onset to inclusion) at baseline was 0.77 (SD 0.79), which is slightly slower progression than has been reported in other ALS studies (0.81,48 – ALSFRS-R at ‘time of diagnosis’/duration from onset to diagnosis) (21). Despite the curvilinear progression of ALS (22), this calculation method is based on a simplified linear progression model of ALS. Median time since symptom onset at baseline was 23 months. After 3.5 months the mean follow-up on-site ALSFRS-R was 31.9 (SD 8.7) compared to online 31.8 (SD 8.7). Correlation between baseline and first online ALS FRS-R was very high with a coefficient of 0.96 (p < 0.001) (Figure 2). We found very high correlations between ALSFRS-R scores at two time-points administered in-clinic compared to through the internet. There was no evidence of systematic bias towards higher or lower scores online. We also found that patients did not consider online ALSFRS-R entry to be physically or emotionally burdensome, or to be time-consuming. We propose for future development that a time-span between online assessments adapted to a given patient's rate of progression could be even more efficient. Completing PROs online could be a way to complement face-to-face visits and manage care in a more personalized and needs-based way, rather than relying upon regular time-intervals such as 3- or 6-month follow-up appointments. Online PROs could also be used to improve the convenience and thereby participation in clinical trials that use the ALSFRS-R as an endpoint. Source: http://doi.org/10.3109/17482968.2011.633268