Although a variety of pain and physical functioning outcome measures have been reported in the literature , few have demonstrate method ologically strong psychometric properties .
INTRODUCTION A range of outcome measures across various domains are used to evaluate change following an intervention in clinical trials on chronic neuropathic pain ( NeP ) .
However , to capture a real change in the variable of interest , the psychometric properties of a particular measure should demonstrate appropriate method ological quality .
Various outcome measures in the domains of pain and physical functioning have been used in the literature for NeP , for which individual properties ( eg , reliability/validity ) have been reported .
Validation of the Toronto Clinical Scoring System for diabetic polyneuropathy.
OBJECTIVE The aim of the current study was to determine the validity of the Toronto Clinical Scoring System ( CSS ) in reflecting the presence and severity of  diabetic peripheral sensorimotor polyneuropathy ( DSP )  as determined by myelinated fiber density ( FD ) on sural nerve biopsy . RESEARCH DESIGN AND METHODS Eighty-nine patients with both type 1 and type 2 diabetes , ascertained from a large therapeutic r and omized controlled trial , were included in this cross-sectional , observational cohort study . Morphological severity of DSP was expressed as the FD in the sural nerve biopsy . The Toronto CSS was applied to all patients to determine a clinical neuropathy score . General linear regression models were used to assess the relationship between the morphological severity of DSP and the Toronto CSS .  RESULTS The Toronto CSS showed a significant negative correlation with sural nerve FD ( R(2 ) = 0.256 , P < 0.0001 ) . The Toronto CSS was lower in those with better glycemic control ( HbA(1c ) < /=8 % ) . Sural nerve FD and the Toronto CSS showed strong correlations with electrophysiology , by both summed amplitude and summed conduction velocity values . CONCLUSIONS The Toronto CSS is a valid instrument to reflect the presence and severity of DSP as measured by sural nerve morphology and electrophysiology . The results of the current study underscore the interrelationships between clinical deficits , electrophysiological findings , and morphological changes in DSP . This evidence suggests that the Toronto CSS may prove useful in documenting and monitoring DSP in the clinic and in clinical research trials
Although a variety of pain and physical functioning outcome measures have been reported in the literature , few have demonstrate method ologically strong psychometric properties .
INTRODUCTION A range of outcome measures across various domains are used to evaluate change following an intervention in clinical trials on chronic neuropathic pain ( NeP ) .
However , to capture a real change in the variable of interest , the psychometric properties of a particular measure should demonstrate appropriate method ological quality .
Various outcome measures in the domains of pain and physical functioning have been used in the literature for NeP , for which individual properties ( eg , reliability/validity ) have been reported .