Minimal clinically important worsening on the progressive supranuclear Palsy Rating Scale

Abstract

Structured Abstract Introduction Despite the widespread use of the PSP rating scale it is not known what change in this scale is meaningful for patients. Methods We analyzed data from a large clinical trial in PSP-Richardson’s syndrome (AL-108-231) to calculate minimal clinically important worsening. This was defined as the difference in mean change of PSP rating scale in subjects rated ‘a little worse’ and those rated ‘unchanged’ on the Clinicians’ Global Impression of Change Scale. A multivariate analysis using logistic regression assessed the relationship between clinical worsening, PSP rating scale, depression and activities of daily living. Results The minimal clinically important worsening on the PSP rating scale was 5.7 points, corresponding to the mean decline over six months in the trial. Changes in activities of daily living and PSP rating scale were significantly associated with clinical worsening. Conclusion Clinically meaningful change is measurable on the PSP rating scale over six months.

Minimal clinically important difference of voice handicap index‐10 in vocal fold paralysis

“…Other fields of medicine have established clearly defined MCID in various PRO measures within their domains . Similar attempts have only recently been undertaken in otolaryngology.…”

“…42 Other fields of medicine have established clearly defined MCID in various PRO measures within their domains. [11][12][13][15][16][17][18][19][20][21]23,24,26,27,[30][31][32][33][34][35][36][37] Similar attempts have only recently been undertaken in otolaryngology. To date in our field, the MCID has been described for the Sinonasal Outcome Test-22 (rhinology), 43 44 the Penn Acoustic Neuroma Quality of Life (otology), 25 the EuroQOL 5-Dimension questionnaire (facial plastics), 45 and the anterior skull base surgery questionnaire (skull base).…”

“…The MCID has been developed for many patient‐based measures in other fields of medicine including rheumatology, pulmonology, obstetrics–gynecology, neurology, neurosurgery, physical medicine and rehabilitation, and orthopedics, among others . However, no voice‐related PRO instrument has a defined MCID.…”

“…29 The MCID has been developed for many patientbased measures in other fields of medicine including rheumatology, pulmonology, obstetrics-gynecology, neurology, neurosurgery, physical medicine and rehabilitation, and orthopedics, among others. [11][12][13][15][16][17][18][19][20][21]23,24,26,27,[30][31][32][33][34][35][36][37] However, no voice-related PRO instrument has a defined MCID. The goal of this study was to define the MCID for the VHI-10 in patients with unilateral vocal fold paralysis (UVFP)/immobility.…”

Effects of anodal transcranial direct current stimulation on cognitive dysfunction in patients with progressive supranuclear palsy

“…We calculated the required sample size based on the primary endpoint (PSP-R). Based on the published literature, 20 the minimum clinically important change in PSP-R over time is 5.7 and the anticipated standard deviation 3.7, which corresponds to an effect size Cohen d=1.51. Thus, the required sample size for a paired t-test to detect such a difference with a 0.8 power at a significance level of 0.05 is 6 patients.…”