title: Validation of the Toronto Clinical Scoring System for diabetic polyneuropathy. WHICH QUESTIONNAIRE IS BEST? THE RELIABILITY, VALIDITY AND EASE OF USE OF THE PATIENT EVALUATION MEASURE, THE DISABILITIES OF THE ARM, SHOULDER AND HAND AND THE MICHIGAN HAND OUTCOME MEASURE Relationship between clinical examination, Quality of Life, disability and depression in CMT patients: Italian Multicenter study Sensory evaluation of the hands in patients with Charcot-Marie-Tooth disease using Semmes-Weinstein monofilaments. Development of a severity score for CRPS Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale The Impact of Acute Herpes Zoster Pain and Discomfort on Functional Status and Quality of Life in Older Adults Development and initial validation of an expanded and revised version of the Short-form McGill Pain Questionnaire (SF-MPQ-2) The clinical importance of changes in the 0 to 10 numeric rating scale for worst, least, and average pain intensity: analyses of data from clinical trials of duloxetine in pain disorders. Total neuropathy score The Validity of the Neuropathic Pain Scale for Assessing Diabetic Neuropathic Pain in a Clinical Trial Reliability and validity of the CMT neuropathy score as a measure of disability Test–retest and interobserver reliability of quantitative sensory testing according to the protocol of the German Research Network on Neuropathic Pain (DFNS): A multi-centre study Assessment of pain quality in chronic neuropathic and nociceptive pain clinical trials with the Neuropathic Pain Scale. Development of a measure of the burden of pain due to herpes zoster and postherpetic neuralgia for prevention trials: adaptation of the brief pain inventory. Reliability of clinical outcome measures in Charcot-Marie-Tooth disease
abstract: 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 The  Patient Evaluation Measure ( PEM ) , The  Michigan H and Outcome Question naire ( MHQ )  and the Disabilities of the Arm , Shoulder and H and ( DASH ) score were assessed independent of their originators for reliability , construct and criterion validity and acceptability , using an ease of use question naire . These were administered in r and om order to 100 patients with different h and and wrist disorders and with different impairments of movement , pain , sensation and strength . The internal consistency of all three question naires was very high suggesting redundancy in the questions . All question naires were reproducible and valid for finger and wrist disorders , but less for nerve disorders . All had poor construct validity . The PEM was the easiest to underst and and complete , taking the least time . Correlation between the scales is high and conversion equations were calculated . All three are reliable and reproducible patient completed question naires , but the PEM is the easiest to use . The validity of all is suspected for nerve disorders Objective To assess which are the clinical examination tests that are more related to quality of life ( QoL ) , depression , and disability in CMT patients . Design Large prospect i ve multicenter study through the use of vali date d clinical , disability , and QoL measurements . Correlations between clinical pattern and disability/QoL and depression were studied . Setting Departments of Neurology . Patients and participants 211 CMT patients ( 60 % females , mean age 42.5 years ) . Interventions None . Measurements and results Sensory function was related to both mental and physical aspects of patient ’s QoL. Ability to walk on toes and heels was related to physical aspects of QoL/disability but also to bodily pain . Strength of forearm/h and intrinsic muscles was related to disability and physical aspects of QoL. Conclusions Some clinical tests may be better outcome measures than others because they are related to aspects of life highly relevant to the patients . This information may be useful in clinical practice and in clinical trials to infer the patient ’s In this study , the intra- and interobserver reliability of the Semmes-Weinstein monofilaments ( SWMFs ) was determined in the h and s of 15 patients with Charcot-Marie-Tooth disease . In addition , the amount and distribution of sensory loss in the h and , and the relation between sensory loss , intrinsic muscle strength , and h and dexterity was explored in 45 patients .  SWMF testing had good intra- and interobserver reliability with intraclass correlation coefficients of 0.91 and 0.86 , respectively . The SWMF testing revealed normal sensory function in 43 % of all six locations . The average loss of the intrinsic h and muscle strength was 57 % . Poor strength was found in patients with both poor and with good sensory function . The correlation between the measurements of intrinsic muscle strength and the Sollerman test for dexterity was 0.70 & NA ; The clinical diagnosis of Complex Regional Pain Syndrome ( CRPS ) is a dichotomous ( yes/no ) categorization necessary for clinical decision‐making . However , such dichotomous diagnostic categories do not convey an individual 's subtle and temporal gradations in severity of the condition , and have poor statistical power when used as an outcome measure in research . This study evaluated the validity and potential utility of a continuous type score to index severity of CRPS . Psychometric and medical evaluations were conducted in 114 CRPS patients and 41 non‐CRPS neuropathic pain patients . Based on the presence/absence of 17 clinical ly‐assessed signs and symptoms of CRPS , an overall CRPS Severity Score ( CSS ) was derived . The CSS discriminated well between CRPS and non‐CRPS patients ( p < .001 ) , and displayed strong associations with dichotomous CRPS diagnoses using both IASP diagnostic criteria ( Eta = 0.69 ) and proposed revised criteria ( Eta = 0.77–0.88 ) . Higher CSS was associated with significantly higher clinical pain intensity , distress , and functional impairments , as well as greater bilateral temperature asymmetry and thermal perception abnormalities ( p ’s < .05 ) . In an archival prospect i ve data set , increases in anxiety and depression from pre‐surgical baseline to 4 weeks post‐knee arthroplasty were found to predict significantly higher CSS at 6‐ and 12‐month follow‐up ( p ’s < .05 ) . Results indicate the CSS corresponds with and complements currently accepted dichotomous diagnostic criteria for CRPS , and support its validity as an index of CRPS severity . Its utility as an outcome measure in research studies is also suggested , with potential statistical advantages over dichotomous diagnostic criteria & NA ;  Pain intensity is frequently measured on an 11‐point pain intensity numerical rating scale ( PI‐NRS ) , where 0=no pain and 10=worst possible pain . However , it is difficult to interpret the clinical importance of changes from baseline on this scale ( such as a 1‐ or 2‐point change ) . To date , there are no data driven estimates for clinical ly important differences in pain intensity scales used for chronic pain studies . We have estimated a clinical ly important difference on this scale by relating it to global assessment s of change in multiple studies of chronic pain . Data on 2724 subjects from 10 recently completed placebo‐controlled clinical trials of pregabalin in diabetic neuropathy , postherpetic neuralgia , chronic low back pain , fibromyalgia , and osteoarthritis were used . The studies had similar design s and measurement instruments , including the PI‐NRS , collected in a daily diary , and the st and ard seven‐point patient global impression of change ( PGIC ) , collected at the endpoint . The changes in the PI‐NRS from baseline to the endpoint were compared to the PGIC for each subject . Categories of ‘ much improved ’ and ‘ very much improved ’ were used as determinants of a clinical ly important difference and the relationship to the PI‐NRS was explored using graphs , box plots , and sensitivity/specificity analyses . A consistent relationship between the change in PI‐NRS and the PGIC was demonstrated regardless of study , disease type , age , sex , study result , or treatment group . On average , a reduction of approximately two points or a reduction of approximately 30 % in the PI‐NRS represented a clinical ly important difference . The relationship between percent change and the PGIC was also consistent regardless of baseline pain , while higher baseline scores required larger raw changes to represent a clinical ly important difference . The application of these results to future studies may provide a st and ard definition of clinical ly important improvement in clinical trials of chronic pain therapies . Use of a st and ard outcome across chronic pain studies would greatly enhance the comparability , validity , and clinical applicability of these studies Objectives To describe the interference of herpes zoster ( HZ ) pain and discomfort with activities of daily living ( ADLs ) and health-related quality of life ( HRQL ) during the acute rash phase , and to quantify the relationship between acute HZ pain and discomfort and impaired ADLs and HRQL in older persons . Methods Prospect i ve , observational study of 160 HZ out patients age ≥60 at 4 US study sites who completed the Zoster Brief Pain Inventory ( ZBPI ) , Zoster Impact Question naire ( ZIQ ) , McGill Pain Question naire , EuroQol , and SF-12 question naires on a predetermined schedule . Patients rated interference on a 0 to 10 scale for ADL items in the ZBPI and the ZIQ . Interference scores were averaged to create summary measures for the ZBPI items ( ZBPI ADLI ) and ZIQ items ( ZIQ ADLI ) . A composite pain score was used in mixed-effects models analyses of the association between pain and discomfort and ADLI and HRQL measures during the first 35 days after HZ rash onset . Results HZ pain interfered with all ADLs but interference was greatest for enjoyment of life , sleep , general activity , leisure activities , getting out of the house , and shopping . For every 1.0 point increase in pain and discomfort intensity , there was a 0.69 and 0.53 point increase in ZBPI and ZIQ interference , respectively , and a 2.81 point , 1.57 point , and 1.95 point decrease in EuroQol , SF-12 physical , and SF-12 mental scales , respectively . Discussion Acute zoster pain and discomfort has a significant negative impact on functional status and HRQL in older adults . The magnitude of interference increases with increasing pain and discomfort intensity ABSTRACT The objective of the present research was to develop a single measure of the major symptoms of both neuropathic and non‐neuropathic pain that can be used in studies of epidemiology , natural history , pathophysiologic mechanisms , and treatment response . We exp and ed and revised the Short‐form McGill Pain Question naire1 ( SF‐MPQ ) pain descriptors by adding symptoms relevant to neuropathic pain and by modifying the response format to a 0–10 numerical rating scale to provide increased responsiveness in longitudinal studies and clinical trials . The reliability , validity , and subscale structure of the revised SF‐MPQ ( SF‐MPQ‐21 )  were examined in responses from 882 individuals with diverse chronic pain syndromes and in 226 patients with painful diabetic peripheral neuropathy who participated in a r and omized clinical trial . The data suggest that the SF‐MPQ‐2 has excellent reliability and validity , and the results of both exploratory and confirmatory factor analyses provided support for four readily interpretable subscales — continuous pain , intermittent pain , predominantly neuropathic pain , and affective descriptors . These results provide a basis for use of the SF‐MPQ‐2 in future clinical research , including clinical trials of treatments for neuropathic and non‐neuropathic pain conditions UNLABELLED Data on 1,700 patients pooled from 5 r and omized , placebo-controlled duloxetine studies ( 3 in diabetic peripheral neuropathic pain and 2 in fibromyalgia ) were analyzed to determine clinical ly important differences ( CIDs ) in the 0 to 10 Numeric Rating Scale-Pain Intensity ( NRS-PI ) for patient-reported " worst " and " least " pain intensity while validating the previously published level for " average " pain . The correspondence between the baseline-to-endpoint raw and percentage change in the NRS-PI for the worst , least , and average pain were compared to patients ' perceived improvements at endpoint as measured by the 7-point Patient Global Impression of Improvement ( PGI-I ) scales . Stratification by baseline pain separated the raw but not the percent change scores . The PGI-I category of " much better " or above was our a priori definition of a CID . Cutoff points for the NRS-PI change scores were determined using a receiver operator curve analysis . A consistent relationship between the worst and average NRS-PI percent change and the PGI-I was demonstrated regardless of the study , pain type , age , sex , or treatment group with a reduction of approximately 34 % . The least pain item CID was slightly higher at 41 % . Raw change CID cutoff points were approximately -2 , -2.5 and -3 for least , average , and worst pain respectively . PERSPECTIVE We determined an anchor-based value for the change in the worst , least , and average pain intensity items of the Brief Pain Inventory that best represents a clinical ly important difference . Our findings support a st and ard definition of a clinical ly important difference in clinical trials of chronic-pain therapies Objective : To determine the validity and reliability of the  total neuropathy score ( TNS ) in normal subjects and in subjects with diabetic polyneuropathy . Background : Clinical research in peripheral neuropathy requires vali date d outcome measures . Multiple outcome measures have been used in clinical trials , including symptom measures , functional scales , quantitative clinical examinations , nerve conduction studies , computerized sensory examinations , and nerve biopsy . Each of these measures has its strengths and weaknesses . In two previous studies of toxic neuropathy from chemotherapeutic agents , the authors used the TNS as the outcome measure . The TNS combines information obtained from grading of symptoms , signs , nerve conduction studies , and quantitative sensory tests , and provides a single measure to quantify neuropathy . Methods : The authors measured the inter- and intrarater reliability of the TNS and preformed a cross-sectional validation study of the TNS and its subscales with the Mayo Clinic measures of neuropathy , neuropathy symptom score ( NSS ) , and the neurologic impairment score ( NIS ) in five healthy control subjects and 30 individuals with varying severities of diabetic polyneuropathy . Results : Inter- and intrarater reliability of the TNS  was excellent ( 0.966 and 0.986 respectively ) . The cross-sectional validation study showed excellent correlations among all measures of neuropathy . Conclusions : The total neuropathy score is a vali date d measure of peripheral nerve function and could be used as an end point for clinical trials of peripheral neuropathy Objectives : In controlled trials of analgesics for the treatment of neuropathic pain , the primary outcome variable is most often a measure of global pain intensity . However , because neuropathic pain is associated with a variety of pain sensations , the effects of analgesic treatments on different sensations could go undetected if specific pain qualities are not assessed . This study sought to evaluate the utility of assessing the multiple components of neuropathic pain in an analgesic clinical trial . Methods : One hundred fifty-nine subjects with diabetes-related foot pain were r and omly assigned to receive an active analgesic ( controlled-release oxycodone ) or matching placebo for 6 weeks . A multidimensional measure of neuropathic pain , the Neuropathic Pain Scale ( NPS ) , was administered before , during , and after study treatment . Results : Relative to placebo , the opioid analgesic produced statistically significantly greater decreases in global pain intensity , pain unpleasantness , and sharp , dull , and deep pain sensations . Responder analyses indicated a higher rate of responding to the opioid condition , relative to placebo , for intense , unpleasant , deep , and surface pain . The opioid analgesic did not significantly reduce hot , cold , itchy , or sensitive pain sensations compared with placebo in either analysis . Conclusions : These findings support the utility of the NPS for characterizing the multidimensional nature of the neuropathic pain experience and for detecting changes in neuropathic pain with treatment Objective : To determine the validity and reliability of the Charcot-Marie-Tooth disease ( CMT ) neuropathy score ( CMTNS ) in patients with inherited neuropathy . Background : Natural history studies and potential treatment trials for patients with various forms of CMT are limited by the lack of quantitative method ologies to monitor disease progression . Most cases of CMT can be considered length-dependent axonal neuropathies because disability for even the demyelinating forms correlates with length-dependent axonal degeneration . The  total neuropathy score ( TNS ) is a vali date d composite measure of disability in length-dependent axonal neuropathies but is weighted toward predominantly sensory neuropathies . Thus , the authors have devised a CMTNS , modified from the TNS , to provide a single measure to quantify CMT disability . Methods : The authors measured inter- and intrainvestigator reliability of the CMTNS and performed a validation of the score with the Neuropathy Impairment Score ( NIS ) , patient self- assessment scores , an ambulation index , and other measures of disability . Results : Inter- and intrainvestigator reliability was more than 95 % in the 60 patients evaluated . Patients could be divided into mild ( CMTNS , ≤10 ) , moderate ( CMTNS , 11 to 20 ) , and severe ( CMTNS , ≥21 ) categories and demonstrated excellent correlations among all measures of disability . Conclusion : The Charcot-Marie-Tooth disease ( CMT ) neuropathy score is a vali date d measure of length-dependent axonal and demyelinating CMT disability and can be investigated as an end point for longitudinal studies and clinical trials of CMT & NA ; Quantitative sensory testing ( QST ) is an instrument to assess positive and negative sensory signs , helping to identify mechanisms underlying pathologic pain conditions . In this study , we evaluated the test – retest reliability ( TR‐R ) and the interobserver reliability ( IO‐R ) of QST in patients with sensory disturbances of different etiologies . In 4 centres , 60 patients ( 37 male and 23 female , 56.4 ± 1.9 years ) with lesions or diseases of the somatosensory system were included .  QST comprised 13 parameters including detection and pain thresholds for thermal and mechanical stimuli .  QST was performed in the clinical ly most affected test area and a less or unaffected control area in a morning and an afternoon session on 2 consecutive days by examiner pairs ( 4 QSTs/patient ) . For both , TR‐R and IO‐R , there were high correlations ( r = 0.80–0.93 ) at the affected test area , except for wind‐up ratio ( TR‐R : r = 0.67 ; IO‐R : r = 0.56 ) and paradoxical heat sensations ( TR‐R : r = 0.35 ; IO‐R : r = 0.44 ) . Mean IO‐R ( r = 0.83 , 31 % unexplained variance ) was slightly lower than TR‐R ( r = 0.86 , 26 % unexplained variance , P < .05 ) ; the difference in variance amounted to 5 % . There were no differences between study centres . In a subgroup with an unaffected control area ( n = 43 ) , reliabilities were significantly better in the test area ( TR‐R : r = 0.86 ; IO‐R : r = 0.83 ) than in the control area ( TR‐R : r = 0.79 ; IO‐R : r = 0.71 , each P < .01 ) , suggesting that disease‐related systematic variance enhances reliability of QST . We conclude that st and ardized QST performed by trained examiners is a valuable diagnostic instrument with good test – retest and interobserver reliability within 2 days . With st and ardized training , observer bias is much lower than r and om variance . Quantitative sensory testing performed by trained examiners is a valuable diagnostic instrument with good interobserver and test – retest reliability for use in patients with sensory disturbances of different etiologies to help identify mechanisms of neuropathic and non‐neuropathic pain UNLABELLED Although a number of measures of pain qualities exist , little research has examined the potential for these measures to identify the unique effects of pain treatments on different pain qualities . We examined the utility of the Neuropathic Pain Scale ( NPS ) for assessing changes in pain qualities after open label lidocaine patch 5 % in 3 sample s of patients : patients with peripheral neuropathic pain , low back pain , and osteoarthritis . With one exception ( " cold " pain in subjects with low back pain ) , each of the NPS items showed significant change after open label lidocaine patch . In addition , significantly larger changes were observed for the NPS items reflecting global pain intensity and pain unpleasantness and for items assessing sharp and deep pain than for items assessing cold , sensitive , and itchy pain . The pattern of changes in pain qualities did not differ across the 3 diagnostic groups , but it did differ from the patterns of changes in pain qualities associated with other analgesic treatments . The results support the potential utility of the NPS for assessing the patterns of changes in pain qualities that can be observed after pain treatment . PERSPECTIVE Pain clinical trials that include measures of pain qualities , such as the NPS , might identify distinct patterns of treatment effects on those pain qualities . This research might be used to help clinicians target analgesics to match the specific qualities associated with a patient 's pain and to better underst and the mechanisms of analgesic effects in drug development programs UNLABELLED In preparation for clinical trials of a vaccine against herpes zoster ( HZ ) , we conducted a prospect i ve , observational study to evaluate ( 1 ) the Zoster Brief Pain Inventory ( ZBPI ) , an HZ-specific question naire to quantify HZ pain and discomfort , ( 2 ) an operational definition of postherpetic neuralgia ( PHN ) , and ( 3 ) a severity- duration measure of the burden of illness caused by HZ . HZ patients aged 60 years or older ( n = 121 ) were enrolled within 14 days of rash onset and completed ZBPI , McGill Pain Question naire Present  Pain Intensity  ( PPI ) ,  quality of life ( QoL ) , and activities of daily living ( ADL ) question naires on a predetermined schedule . Reliability , measured by intraclass correlation coefficients within 14 days of rash onset , ranged between 0.63 and 0.78 . ZBPI pain scores were strongly correlated with other pain measures , interference with ADL , and worsening QoL. The operational definition of PHN , a ZBPI pain score of 3 or greater occurring 90 or more days after rash onset , had high agreement with pain worse than mild on the PPI ( kappa = 0.72 ) . The ZBPI pain severity- duration measure had high correlations with severity- duration measures of ADL interference , worsening QoL , and other pain scales . These findings support the validity and utility of the ZBPI , the definition of PHN , and the severity- duration measure of the burden of HZ illness . PERSPECTIVE Herpes zoster pain , as measured by the ZBPI severity- duration measure , is associated with impairment in daily living activities and quality of life . The ZBPI measure appears useful for quantifying herpes zoster pain , postherpetic neuralgia , and impairment in daily living activities for clinical trials of herpes zoster prevention We assessed inter- and intra-rater reliability of outcome measures in Charcot-Marie-Tooth disease ( CMT ) patients . In 40 CMT patients , we assessed reliability of Overall Neuropathy Limitations Scale ( ONLS ) , 10-m timed walk ( T10MW ) , 9-hole-peg test ( 9-HPT ) , maximal voluntary isometric contraction ( MVIC ) of arm ( elbow flexion , h and -grip , and three-point pinch ) and leg ( knee extension , foot dorsiflexion/plantar flexion ) . Reliability was substantial for ONLS , excellent for T10MW and 9-HPT . For MVIC , inter and intra-rater reliability was excellent for h and contractions ; for leg contractions , intra-rater agreement was moderate to substantial , whereas inter-rater agreement was poor . An ad hoc device was produced to immobilize the foot and MVIC reliability was re-assessed in 26 CMT patients , result ing in excellent inter-rater and intra-rater reliability for foot dorsiflexion , and clear inter-rater improvement for foot plantar flexion . All outcome measures appear adequate for CMT assessment . Use of an immobilization device improves foot MVIC reliability , preventing biased findings in patients with greater strength
target: Although a variety of pain and physical functioning outcome measures have been reported in the literature , few have demonstrate method ologically strong psychometric properties .
background: 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 .