Assessment of study quality for systematic reviews: a comparison of the Cochrane Collaboration Risk of Bias Tool and the Effective Public Health Practice Project Quality Assessment Tool: methodological research. The prevalence and impact of chronic pain with neuropathic pain symptoms in the general population. An open-label, non-randomized comparison of venlafaxine and gabapentin as monotherapy or adjuvant therapy in the management of neuropathic pain in patients with peripheral neuropathy A menopause-specific quality of life questionnaire: development and psychometric properties. The stroke impact scale version 2.0. Evaluation of reliability, validity, and sensitivity to change. The Bournemouth Questionnaire: a short-form comprehensive outcome measure. I. Psychometric properties in back pain patients. The lower-limb tasks questionnaire: an assessment of validity, reliability, responsiveness, and minimal important differences. Development of a brief measure to assess quality of life in obesity. painDETECT: a new screening questionnaire to identify neuropathic components in patients with back pain The short-form chronic respiratory disease questionnaire was a valid, reliable, and responsive quality-of-life instrument in acute exacerbations of chronic obstructive pulmonary disease. Further psychometric property development of the Menopause-Specific Quality of Life questionnaire and development of a modified version, MENQOL-Intervention questionnaire. Reliability and validity of King's Health Questionnaire in patients with symptoms of overactive bladder with urge incontinence in Japan. An open-label comparison of nabilone and gabapentin as adjuvant therapy or monotherapy in the management of neuropathic pain in patients with peripheral neuropathy. Psychometric validation of the O'leary-Sant interstitial cystitis symptom index in a clinical trial of pentosan polysulfate sodium. Which questionnaire? A psychometric evaluation of three patient-based outcome measures used to assess surgery for stress urinary incontinence. Pharmacological management of chronic neuropathic pain - consensus statement and guidelines from the Canadian Pain Society. The Glasgow Sleep Impact Index (GSII): a novel patient-centred measure for assessing sleep-related quality of life impairment in Insomnia Disorder. Validation of the Psoriasis Symptom Inventory (PSI), a patient-reported outcome measure to assess psoriasis symptom severity Physical Impairment Index: Reliability, Validity, and Responsiveness in Patients with Acute Low Back Pain Rasch analysis of a new stroke-specific outcome scale: the Stroke Impact Scale. Psychometric properties of the activities-specific balance confidence scale and the survey of activities and fear of falling in older women. Psychometric properties of the Multidimensional Pain Inventory, Dutch language version (MPI-DLV). Investigating the relationship between pain and discomfort and quality of life, using the WHOQOL
BACKGROUND The Cochrane Collaboration is strongly encouraging the use of a newly developed tool , the Cochrane Collaboration Risk of Bias Tool ( CCRBT ) , for all review groups . However , the psychometric properties of this tool to date have yet to be described . Thus , the objective of this study was to add information about psychometric properties of the CCRBT including inter-rater reliability and concurrent validity , in comparison with the Effective Public Health Practice Project Quality Assessment Tool ( EPHPP ) . METHODS Both tools were used to assess the method ological quality of 20 r and omized controlled trials included in our systematic review of the effectiveness of knowledge translation interventions  to improve the management of cancer pain . Each study assessment was completed independently by two review ers using each tool . We analysed the inter-rater reliability of each tool 's individual domains , as well as final grade assigned to each study . RESULTS The EPHPP had fair inter-rater agreement for individual domains and excellent agreement for the final grade . In contrast , the CCRBT had slight inter-rater agreement for individual domains and fair inter-rater agreement for final grade . Of interest , no agreement between the two tools was evident in their final grade assigned to each study . Although both tools were developed to assess ' quality of the evidence ' , they appear to measure different constructs . CONCLUSIONS Both tools performed quite differently when evaluating the risk of bias or method ological quality of studies in knowledge translation interventions for cancer pain . The newly introduced CCRBT assigned these studies a higher risk of bias . Its psychometric properties need to be more thoroughly vali date d , in a range of research fields , to underst and fully how to interpret results from its application OBJECTIVE We performed a prevalence estimate of chronic pain with neuropathic pain ( NeP ) symptoms to determine its frequency and associations with morbidity . DESIGN We conducted a telephone-based survey based upon a r and om sampling of both urban and rural households of the general population in one Canadian province to determine NeP prevalence and its impact upon financial well-being and quality of life . OUTCOME MEASURES Telephonic use of the DN4 question naire ( DN4Q ) , used to identify NeP symptoms in those patients with chronic pain , was vali date d within selected clinical population s of chronic pain . Epidemiological data was obtained for all subjects . EuroQoL (EQ)-5D data estimating quality of life was measured . RESULTS Chronic pain was present in 35.0 % of the surveyed population of 1,207 subjects , with NeP symptoms present in 17.9 % . The NeP group had significantly more pain  , was female predominant , had a greater belief of being economically disadvantaged , suffered from more restrictions in mobility and in usual activities , and had overall lower EQ-5D utility scores compared with subjects with non-NeP. DN4Q validation demonstrated that pain entities not normally defined as NeP are recorded as such using the DN4Q , and that a spectrum of NeP features may occur across a host of painful conditions . CONCLUSION Despite limitations of the DN4Q , symptoms of NeP may be more prevalent in the general population than expected and has a greater impact upon patients ' lives than non-NeP. Limitations of the DN4Q may relate to the concept of a spectrum of NeP existent amongst heterogenous NeP and non-NeP syndromes Although many therapies are used in the management of neuropathic pain ( NeP ) due to polyneuropathy ( PN ) , few comparison studies exist . We performed a prospect i ve , non-r and omized , unblended , efficacy comparison of the serotonin-norepinephrine reuptake inhibitor venlafaxine , as either monotherapy or adjuvant therapy , with a first-line medication for NeP , gabapentin , in patients with PN-related NeP.  VAS pain scores were assessed after 3 and 6 months in intervention groups and in a cohort of patients receiving no pharmacotherapy .  In a total of 223 patients , we analyzed pain quantity and quality ( visual analogue scale [ VAS ] score , Brief Pain Inventory [ BPI ] ) , quality of life and health status measures [ EuroQol 5 Domains , EQ-5D ] , Medical Outcomes Sleep Study Scale [ MOSSS ] , Hospital Anxiety and Depression Scale [ HADS ] and Short Form 36 Health Survey [ SF-36 ] ) after 6 months of therapy . Significant improvements in VAS pain scores occurred for all treatment groups after 6 months . Improvements in aspects of daily life and anxiety were identified in all treatment groups . Our data suggest that monotherapy or adjuvant therapy with venlafaxine is comparable to gabapentin for NeP management . We advocate for head-to-head , r and omized , double-blinded studies of current NeP therapies OBJECTIVE To develop a condition-specific quality of life question naire for the menopause with documented psychometric properties , based on women 's experience . METHODS SUBJECTS Women 2 - 7 years post-menopause with a uterus and not currently on hormone replacement therapy . Question naire development : A list of 106 menopause symptoms was reduced using the importance score method . Replies to the item-reduction question naire from 88 women result ed in a 30-item question naire with four domains , vasomotor , physical , psychosocial and sexual , and a global quality of life question . Psychometric properties : A separate sample of 20 women was used to determine face validity , and a panel of experts was used to confirm content validity . Reliability , responsiveness and construct validity were determined within the context of a r and omized controlled trial . Construct validation involved comparison with the Neugarten and Kraines'Somatic , Psychosomatic and Psychologic subscales , the reported intensity of hot flushes , the General Well-Being Schedule , Channon and Ballinger 's Vaginal Symptoms Score and Libido Index , and the Life Satisfaction Index . RESULTS The face validity score was 4.7 out of a possible 5 . Content validity was confirmed . Test-retest reliability measures , using intraclass correlation coefficients were 0.81 , 0.79 , 0.70 and 0.55 for the physical , psychosocial , sexual domains and the quality of life question . The intraclass correlation coefficient for the vasomotor domain was 0.37 but there is evidence of systematic change . Discriminative construct validity showed correlation coefficients of 0.69 for the physical domain , 0.66 and 0.40 for the vasomotor domain , 0.65 and -0.71 for the psychosocial domain , 0.48 and 0.38 for the sexual domain , and 0.57 for the quality of life question . Evaluative construct validity showed correlation coefficients of 0.60 for the physical domain , 0.28 for the vasomotor domain , 0.55 and -0.54 for the psychosocial domain , 0.54 and 0.32 for the sexual domain , and 0.12 for the quality of life question . Responsiveness scores ranged from 0.78 to 1.34 . CONCLUSIONS The MENQOL ( Menopause-Specific Quality of Life ) question naire is a self-administered instrument which functions well in differentiating between women according to their quality of life and in measuring changes in their quality of life BACKGROUND AND PURPOSE To be useful for clinical research , an outcome measure must be feasible to administer and have sound psychometric attributes , including reliability , validity , and sensitivity to change . This study characterizes the psychometric properties of the Stroke Impact Scale ( SIS ) Version 2.0 . METHODS Version 2.0 of the SIS is a self-report measure that includes 64 items and assesses 8 domains ( strength , h and function , ADL/IADL , mobility , communication , emotion , memory and thinking , and participation ) . Subjects with mild and moderate strokes completed the SIS at 1 month ( n=91 ) , at 3 months ( n=80 ) , and at 6 months after stroke ( n=69 ) . Twenty-five subjects had a replicate administration of the SIS 1 week after the 3-month or 6-month test . We evaluated internal consistency and test-retest reliability . The validity of the SIS domains was examined by comparing the SIS to existing stroke measures and by comparing differences in SIS scores across Rankin scale levels . The mixed model procedure was used to evaluate responsiveness of the SIS domain scores to change . RESULTS Each of the 8 domains met or approached the st and ard of 0.9 alpha-coefficient for comparing the same patients across time . The intraclass correlation coefficients for test-retest reliability of SIS domains ranged from 0.70 to 0.92 , except for the emotion domain ( 0.57 ) . When the domains were compared with established outcome measures , the correlations were moderate to strong ( 0.44 to 0.84 ) . The participation domain was most strongly associated with SF-36 social role function . SIS domain scores discriminated across 4 Rankin levels . SIS domains are responsive to change due to ongoing recovery . Responsiveness to change is affected by stroke severity and time since stroke . CONCLUSIONS This new , stroke-specific outcome measure is reliable , valid , and sensitive to change . We are optimistic about the utility of measure . More studies are required to evaluate the SIS in larger and more heterogeneous population s and to evaluate the feasibility and validity of proxy responses for the most severely impaired patients OBJECTIVE Develop and test a short-form comprehensive outcome measure for back pain . DESIGN Prospect i ve longitudinal study of 3 consecutive cohorts of back pain patients . SETTING Anglo-European College of Chiropractic outpatient clinic and several field chiropractic practice s. METHOD Domains judged important in the back pain model and responsive to clinical change were identified from the literature . Items were scored on an 11-point numerical rating scale . The instrument was psychometrically tested by use of those tests relevant to an evaluative measure . RESULTS Seven dimensions of the back pain model were included in the question naire . Having established face validity , the instrument was shown to demonstrate high internal consistency ( Cronbach 's alpha = 0.9 ) and good test-retest reliability ( ICC = 0.95 ) . All items were retained on the basis that they contributed to the overall score ( item-corrected total score correlations ) and to the instrument 's responsiveness to clinical change ( item change-corrected total change score correlations ) . The instrument demonstrated acceptable construct and longitudinal construct validity with established external measures . The effect size of the instrument was high ( 1.29 ) and comparable with established measures . CONCLUSION A reliable , valid , and responsive instrument has been developed for use in back pain patients . It is practical for use in investigations of both the efficacy and effectiveness of back pain treatments OBJECTIVES To develop a question naire that focuses only on physical tasks related to lower-limb function and , within that question naire , to explore the psychometric properties of a series of questions that are related specifically to activities of daily living ( ADLs ) and a series of activities more often associated with recreation . DESIGN Inception cohort . SETTING Private practice . PARTICIPANTS Data were primarily from patients who had experienced a lower-limb injury that would typically involve rehabilitation up to 6 weeks . INTERVENTIONS Not applicable . MAIN OUTCOME MEASURES Through 5 studies , the following psychometric qualities were evaluated : content and factor validity , construct and concurrent validity , test-retest reliability ( intraclass correlation coefficient [ ICC ] , typical error ) , responsiveness ( effect size , st and ardized response mean , Guyatt 's responsiveness statistic ) , and the minimum important difference ( distribution , anchor-based approaches ) . RESULTS Factor analysis supported the theoretical perspective that ADLs and recreational activities can be treated as different domains within the construct of function . Internal consistency was high ( Cronbach alpha : ADLs , .91 ; recreational activities , .95 ) and the 2 domains explained a moderate level of the response variance ( 61 % ) . In the ADL domain , 7 tasks had greater than 80 % of participants regarding them as having some importance . For recreational activities , 6 tasks had 79 % or more of participants regarding them as having some importance . Both domains were moderately correlated to actual performance of tasks ( r = .62 , r = .72 ) , and to other question naires used for lower-limb injuries ( r range , .51-.86 ) . The floor and ceiling effects of the domains followed an expected pattern that could be related to the loading forces experienced on the injured limb during activities . The reliability of the 2 domains was high ( ICCs > .95 ) , and the Bl and -Altman plots showed that the distribution of error across the range of scores was r and om with low bias scores ( < 1.0 point ) . Typical error scores were 2 points for each domain . All measures of responsiveness were high ( 1.2 - 6.7 ) . Measures of the minimal important difference varied ( 3 - 10 points ) according to the method ologic approach used . CONCLUSIONS The question naire possesses good factor structure and composition , relates well with other measures of function , differentiates patients with regard to certain characteristics or processes known to occur after injury , shows high levels of reliability and responsiveness , and shows evidence of good minimal important difference scores . The findings support the use of the question naire in both clinical scenarios and in research OBJECTIVE Obesity research ers have a growing interest in measuring the impact of weight and weight reduction on quality of life . The Impact of Weight on  Quality of Life question naire ( IWQOL ) was the first self-report instrument specifically developed to assess the effect of obesity on quality of life . Although the IWQOL has demonstrated excellent psychometric properties , its length ( 74 items ) makes it somewhat cumbersome as an outcome measure in clinical research . This report describes the development of a 31-item version of the IWQOL ( IWQOL-Lite ) . RESEARCH METHODS AND PROCEDURES IWQOLs from 996 obese patients and controls were used to develop the IWQOL-Lite . Psychometric properties of the IWQOL-Lite were examined in a separate cross-validation sample of 991 patients and controls . RESULTS Confirmatory factor analysis provided strong support for the adequacy of the scale structure . The five identified scales of the IWQOL-Lite  ( Physical Function , Self-Esteem , Sexual Life , Public Distress , and Work ) and the total IWQOL-Lite score demonstrated excellent psychometric properties . The reliability of the IWQOL-Lite scales ranged from 0.90 to 0.94 and was 0.96 for the total score . Correlations between the IWQOL-Lite and collateral measures supported the construct validity of the IWQOL-Lite . Changes in  IWQOL-Lite scales over time correlated significantly with changes in weight , supporting its sensitivity to change . Significant differences in IWQOL-Lite scale and total scores were found among groups differing in body mass index , supporting the utility of the IWQOL-Lite across the body mass index spectrum . DISCUSSION The IWQOL-Lite appears to be a psychometrically sound and clinical ly sensitive brief measure of quality of life in obese persons ABSTRACT Objective : Nociceptive and neuropathic components both contribute to pain . Since these components require different pain management strategies , correct pain diagnosis before and during treatment is highly desirable . As low back pain ( LBP ) patients constitute an important subgroup of chronic pain patients , we addressed the following issues : ( i ) to establish a simple , vali date d screening tool to detect neuropathic pain ( NeP ) components in chronic LBP patients , ( ii ) to determine the prevalence of neuropathic pain components in LBP in a large-scale survey , and ( iii ) to determine whether LBP patients with an NeP component suffer from worse , or different , co-morbidities . Methods : In co-operation with the German Research Network on Neuropathic Pain we developed and vali date d the painDETECT question naire ( PD‐Q ) in a prospect i ve , multicentre study and subsequently applied it to approximately 8000 LBP patients . Results : The PD‐Q is a reliable screening tool with high sensitivity , specificity and positive predictive accuracy ; these were 84 % in a palm-top computerised version and 85 % , 80 % and 83 % , respectively , in a corresponding pencil- and -paper question naire . In an unselected cohort of chronic LBP patients , 37 % were found to have predominantly neuropathic pain . Patients with NeP showed higher ratings of pain intensity , with more ( and more severe ) co‐morbidities such as depression , panic/anxiety and sleep disorders . This also affected functionality and use of health-care re sources . On the basis of given prevalence of LBP in the general population , we calculated that 14.5 % of all female and 11.4 % of all male Germans suffer from LBP with a predominant neuropathic pain component . Conclusion : Simple , patient-based , easy-to-use screening question naires can determine the prevalence of neuropathic pain components both in individual LBP patients and in heterogeneous cohorts of such patients . Since NeP correlates with more intense pain , more severe co‐morbidity and poorer quality of life , accurate diagnosis is a milestone in choosing appropriate therapy OBJECTIVE To assess the psychometric properties of the short-form chronic respiratory disease question naire ( SF-CRQ ) as a quality -of-life ( QOL ) instrument in chronic obstructive pulmonary disease ( COPD ) exacerbations . STUDY DESIGN AND SETTING In a prospect i ve multicenter cohort study , consecutive emergency department ( ED ) patients with COPD exacerbation were interviewed using the SF-CRQ and other instruments . Baseline information was collected in the ED and from follow-up data 2 weeks later . The results of the SF-CRQ were compared with the results of the other instruments and clinical variables by correlation and factor analyses . RESULTS Of the 301 enrolled patients , 80 % reported improvements across each of the domains of the SF-CRQ over the 2-week post-ED period . Overall median changes for the dyspnea , fatigue , emotional function , and mastery domains were 2 , 1 , 1 , and 1.5 , respectively ( P<0.001 for each domain ) . Correlation and factor analyses support their convergent/divergent validity and construct validity . The reliability for the change score of the SF-CRQ was high ( Cronbach 's alpha coefficient , 0.82 ) . Overall minimal clinical ly important difference for improvement in the SF-CRQ was 1.01 ( 95 % confidence interval , 0.72 - 1.31 ) . CONCLUSION SF-CRQ is a valid , reliable , and responsive instrument for the assessment of short-term QOL change in patients with COPD exacerbations OBJECTIVES To develop the 1996 MENQOL question naire further with advice regarding summary score computation , missing- data management , readability , recall period and assessment of the vasomotor domain reliability and construct validity . To develop a modified version , the MENQOL-Intervention question naire , for use where certain treatment side effects could negatively impact the quality of life . METHODS MENQOL-Intervention modifications involved the addition of three items to the physical domain . For both question naires , psychometric property assessment was embedded in two r and omized controlled trials of menopause interventions . Test-retest reliability and Cronbach 's alpha were computed for all domains as was construct validity of the vasomotor domain for both question naires . RESULTS The vasomotor intraclass correlation coefficient was 0.73 for the MENQOL-Intervention over 1 week and 0.78 for the MENQOL over 1 month . The altered physical domain of the MENQOL-Intervention question naire continued to show strong test-retest reliability and Cronbach 's alpha consistent with the MENQOL . The MENQOL-Intervention demonstrated excellent face validity with high construct validity for the vasomotor domain of 0.78 - 0.80 . For both instruments , comparisons of the vasomotor domains to hot flash scores , although statistically significant , were only moderate at 0.56 and 0.49 . CONCLUSIONS Both the MENQOL and the MENQOL-Intervention question naires show strong psychometric properties . We recommend using the MENQOL-Intervention question naire where intervention side effects might negatively impact a woman 's quality of life . For both question naires , a summary score can be calculated AIMS The purpose of this study is to evaluate the psychometric properties of the Japanese version of the King 's Health Question naire ( KHQ ) in patients with symptoms of overactive bladder ( OAB ) with urge incontinence . METHODS Data from a 12-week , r and omized , double-blind , placebo-controlled clinical trial comparing tolterodine with oxybutynin in patients with symptoms of OAB in Japan were analyzed . Cronbach 's alpha coefficient was calculated as a reliability index . Inter-domain correlation was calculated for convergent and discriminant validity assessment . A factor analysis was conducted to explore the underlying factor structure of the KHQ . Sensitivity to clinical change was also evaluated . RESULTS The psychometric properties and clinical validity of the KHQ Japanese version were confirmed in this study population , and were similar between males and females . The KHQ 's good reliability was evidence d by Cronbach 's alpha coefficients of > 0.60 , indicating reasonable consistency except for the personal relationship domain in males ( 0.47 ) and severity ( coping ) measure domain in females ( 0.59 ) . Discriminant , convergent , and construct validity of the KHQ were also good , with the factor analysis identifying those factors which the KHQ was intended to measure . Finally , KHQ domains were generally responsive to clinical efficacy variables ; the KHQ also showed statistically significant sensitivity to change in patients ' perception of bladder condition in all domains , except General Health Perception . CONCLUSIONS Our analyses confirm psychometric properties and clinical validity of the KHQ Japanese version , which appears to offer a valid and reliable HRQoL instrument for use in clinical trials of antimuscarinics in Japan Neuropathic pain ( NeP ) is prevalent in patients with peripheral neuropathy ( PN ) , regardless of etiology . We sought to compare the efficacy of the cannabinoid nabilone as either monotherapy or adjuvant therapy with a first-line medication for NeP , gabapentin , in a patient population with PN-NeP. Patients diagnosed with PN-NeP were permitted to initiate monotherapy ( nabilone or gabapentin ) or add one of these two medications ( adjuvant therapy ) to their existing NeP treatment regimen in a non-r and omized open-label nature . Baseline data collected included a primary outcome ( visual analog scores [ VAS ] of pain ) and secondary outcomes ( quality of life [ EuroQol 5 Domains and Short-Form 36 ] assessment s and assessment s of sleep [ Medical Outcomes Sleep Study Scale { MOSSS } ] , anxiety and depression [ Hospital Anxiety and Depression Scale ] , and pain [ Brief Pain Inventory ] ) . Re assessment and modulation of dosing and /or medications occurred at 3- and 6-month intervals . Medication adverse effects and drug efficacy , as well as question naires , were assessed at 6 months . Matched analysis of variance testing was performed to compare 3- and 6-month scores with baseline , as well as to compare therapies at equal time points . Significant improvements in pain VAS were seen in all treatment groups at 6 months . Numerous sleep parameters within MOSSS , Brief Pain Inventory , and Short-Form 36 improved in patients receiving nabilone or gabapentin either as monotherapy or adjuvant treatment . Hospital Anxiety and Depression Scale-A scores were significantly improved in all treatment groups . Sleep adequacy and the sleep problems index within the MOSSS improved in nabilone monotherapy patients in particular . The benefits of monotherapy or adjuvant therapy with nabilone appear comparable to gabapentin for management of NeP. We advocate for head-to-head r and omized , double-blind studies for current therapies for NeP in order to determine potential advantages beneficial in this patient population The O'Leary-Sant Interstitial Cystitis Symptom Index ( ICSI ) has been proposed as a treatment outcome measure in interstitial cystitis ( IC ) . The psychometric properties of the ICSI were assessed for reliability and validity in a r and omized , double-blind clinical study of 300 , 600 , and 900 mg daily dose of pentosan polysulfate sodium ( PPS ) in patients with IC . The ICSI contains 4 items that measure urgency and frequency of urination , nighttime urination , and pain or burning . The ICSI index score is the sum of the item scores ( range : 0 - 20 ) . ICSI scores were obtained at baseline , 4 , 8 , 12 , 16 , 24 , and 32 weeks of treatment . Patients ' overall ratings of improvement of symptoms ( PORIS ) scores evaluating improvements in pain , urgency , and overall IC symptoms were also collected except at baseline . A total of 376 patients were included in the analysis . Psychometric properties evaluated included variability ( range ) , test-retest reliability ( intraclass correlation coefficient [ ICC ] ) , internal consistency ( the Cronbach alpha ) , construct validity ( convergent , discriminant ) , responsiveness , and clinical ly meaningful change . The ICSI items and index score had good variability and test-retest reliability . The ICSI demonstrated internal consistency reliability and was responsive to change . Participants indicating a 75 % improvement in PORIS had a 48 % mean reduction in the ICSI score , while participants reporting 100 % improvement in PORIS had a 77 % mean reduction in the ICSI score . The ICSI is a valid , reliable , and responsive measure of change in IC symptoms . This outcome measure should be utilized in future treatment outcomes studies in IC AIMS The aim of the study was to further vali date three patient-based outcome measures ( PBOM ) used to assess the outcome of surgery for stress urinary incontinence and to compare their psychometric properties with a view to determining the most appropriate measure for clinical use . METHODS The work was embedded within a r and omized controlled trial of laparoscopic and open colposuspension . The trial recruited 291 women from six centers . The three instruments compared were Bristol  Female Lower Urinary Tract Symptom Question naire ( BFLUTS )  ,  Kings Health Question naire ( KHQ )  , and the Symptom Severity Index and Symptom Impact Index ( SSI/SII ) . The International Consultation on Incontinence ( ICI ) ABC grading system of psychometric propertie 's reliability , validity , and responsiveness was used to evaluate the instruments . RESULTS From the analysis of the psychometric properties of the three instruments , the SSI/SII appeared to have the best psychometric profile ; Grade A , BFLUTS was of grade A , and KHQ was of grade B. SSI/SII had a good degree of internal consistency ( Cronbach 's alpha 0.74 - 0.78 ) . BFLUTS and KHQ both had domains in which the internal consistency was < 0.7 . The  SSI domain of the SSI/SII was the only domain to correlate to the 1-hr pad test . All domains of the SSI/SII were able to distinguish those cured from not cured and it was most responsive to change . Unlike the KHQ , the SSI/SII had no significant ceiling or floor effects . CONCLUSIONS This study has demonstrated that when instruments are used in different population s their psychometric properties may change . All three instruments analyzed had limitations when used as an outcome measure for surgery for stress urinary incontinence Neuropathic pain ( NeP ) , generated by disorders of the peripheral and central nervous system , can be particularly severe and disabling . Prevalence estimates indicate that 2 % to 3 % of the population in the developed world suffer from NeP , which suggests that up to one million Canadians have this disabling condition . Evidence -based guidelines for the pharmacological management of NeP are therefore urgently needed . R and omized , controlled trials , systematic review s and existing guidelines focusing on the pharmacological management of NeP were evaluated at a consensus meeting . Medications are recommended in the guidelines if their analgesic efficacy was supported by at least one method ologically sound , r and omized , controlled trial showing significant benefit relative to placebo or another relevant control group . Recommendations for treatment are based on degree of evidence of analgesic efficacy , safety , ease of use and cost-effectiveness .  Analgesic agents recommended for first-line treatments are certain antidepressants ( tricyclics ) and anticonvulsants ( gabapentin and pregabalin ) . Second-line treatments recommended are serotonin noradrenaline reuptake inhibitors and topical lidocaine . Tramadol and controlled-release opioid analgesics are recommended as third-line treatments for moderate to severe pain . Recommended fourth-line treatments include cannabinoids , methadone and anticonvulsants with lesser evidence of efficacy , such as lamotrigine , topiramate and valproic acid . Treatment must be individualized for each patient based on efficacy , side-effect profile and drug accessibility , including cost . Further studies are required to examine head-to-head comparisons among analgesics , combinations of analgesics , long-term outcomes , and treatment of pediatric and central OBJECTIVES Daytime dysfunction and quality of life impairment are important and salient consequences of poor sleep in those with insomnia . Existing measurement approaches to functional impact tend to rely on non-specific generic tools , non-vali date d scales , or ad hoc single scale items . Here we report the development and validation of the Glasgow Sleep Impact Index  ( GSII ) , a novel self-report measure which asks patients to generate , and assess , three domains of impairment unique to their own individual context . These three patient-generated areas of impairment are ranked in order of concern ( 1 - 3 ; i.e. 1=the most concerning impairment ) , and then rated on a visual analogue scale with respect to impact in the past two weeks . Patients re-rate these specified areas of impairment , post-intervention , permitting both individual and group-level analyses . METHODS One-hundred and eight patients ( 71 % female ; Mean age=45 yrs ) meeting Research Diagnostic Criteria for Insomnia Disorder completed the GSII , result ing in the generation of 324 areas ( ranks ) of sleep-related daytime and quality of life impairment . Fifty-five patients also completed the GSII pre- and post-sleep restriction therapy . The following psychometric properties were assessed : content validity of generated domains ; relationship between ranks of impairment ; and sensitivity to change post-behavioural intervention . RESULTS Content analysis of generated domains support recent DSM-5 proposals for specification of daytime consequences of insomnia ; with the most commonly cited areas reflecting impairments in energy/motivation , work performance , cognitive functioning , emotional regulation , health/well-being , social functioning and relationship/family functioning . Preliminary results with 108 patients indicate the GSII to have excellent face and construct validity . The GSII was found to be sensitive to change , post-behavioural treatment ( p<0.001 ; Cohen 's d≥0.85 for all three ranks of impairment ) , and improvements were associated with reductions in insomnia severity in both correlational ( range of r=0.28 - 0.56 ) and responder versus non-responder analyses ( all p<0.05 ) . CONCLUSIONS The development of the GSII represents a novel attempt to capture and measure sleep-related quality of life impairment in a valid and meaningful way . Further psychometric and clinical evaluation is suggested Background : The objective of this study was to evaluate the measurement properties of the Psoriasis Symptom Inventory ( PSI ) , an eight-item patient-reported outcome measure for assessing severity of plaque psoriasis symptoms . Methods : In this prospect i ve , r and omized study using data from adults with moderate-to-severe plaque psoriasis , patients completed the PSI , Dermatology Life Quality Index ( DLQI ) , SF-36v2 Acute , and Patient Global Assessment ( PtGA ) . PSI construct validity was assessed using Spearman rank correlations between PSI and DLQI and SF-36 ; test-retest reliability and sensitivity to change were evaluated using PtGA as an anchor . Daily 24-h and weekly 7-day PSI versions were evaluated . Results : Eight US sites enrolled 143 patients ; 139 ( 97.2 % ) completed the study . All symptoms ( itch , redness , scaling , burning , cracking , stinging , flaking , and pain ) were reported across all response options ( not at all severe , mild , moderate , severe , very severe ) . Test-retest reliability was acceptable ( intraclass correlation coefficients range = 0.70–0.80 ) . A priori hypotheses of convergent and discriminant validity were confirmed by correlations of PSI with DLQI items and SF-36 domains . The PSI demonstrated good construct validity and was sensitive to within-subject change ( p < 0.0001 ) . Conclusions : The PSI is brief , valid , reproducible , and responsive to change and has the potential to be a useful PRO measure in psoriasis clinical trials Study Design . Cohort study of patients with acute low back pain undergoing physical therapy .  Objectives . Examine the reliability and validity of the Physical Impairment Index in a group of patients with acute low back pain and determine the responsiveness and minimum detectable change of the index and its component tests . Summary of the Background Data . The Physical Impairment Index was originally described as a reliable and valid means of assessing physical impairment in patients with low back pain . The psychometric properties of the index have not been reported in patients with acute low back pain , nor has its responsiveness been examined . Methods . Seventy-eight patients with acute ( <3 weeks duration ) low back pain participating in a clinical trial were assessed at baseline and after 4 weeks .  Interrater reliability of the index was examined in a subgroup of 20 patients . Validity was examined through correlations with concurrent measures of pain , disability , and psychosocial variables . Changes in the index over 4 weeks were used to assess responsiveness and minimum detectable change . Results . Interrater reliability of the index was high ( intraclass correlation coefficient = 0.89 ) , and its validity was generally supported by the pattern of correlations . The index was more responsive to change than any of its component tests but was less responsive than the Oswestry disability score . The minimum detectable change on the index was approximately 1 point . Conclusions . The Physical Impairment Index appears to be a reliable and valid measure of physical impairment for patients with acute low back pain and may be useful as an adjunct outcome measure for studies involving these patients . Further research on patients with chronic pain is needed before it can be advocated for outcomes research with this population OBJECTIVES To assess multiple psychometric characteristics of a new stroke outcome measure , the Stroke Impact Scale ( SIS ) , using Rasch analysis , and to identify and remove misfitting items from the 8 domains that comprise the SIS . DESIGN Secondary analysis of 3-month outcomes for the Glycine Antagonist in Neuroprotection ( GAIN ) Americas r and omized stroke trial . SETTING A multicenter r and omized trial performed in 132 centers in the United States and Canada . PARTICIPANTS A total of 696 individuals with stroke who were community-dwelling and independent prior to acute stroke . INTERVENTIONS Not applicable . MAIN OUTCOME MEASURES Rasch analysis was performed using WINSTEPS , version 3.31 , to evaluate 4 psychometric characteristics of the SIS : ( 1 ) unidimensionality or fit ( the extent to which items measure a single construct ) , ( 2 ) targeting ( the extent to which the items are of appropriate difficulty for the sample ) , ( 3 ) item difficulty ( the ordering of items from least to most difficult to perform ) , and ( 4 ) separation ( the extent to which the items distinguish distinct levels of functioning within the sample ) . RESULTS ( 1 ) Within each domain , most of the items measured a single construct . Only 3 items misfit the constructs and were deleted ( " add and subtract numbers , " " get up from a chair , " " feel emotionally connected " ) and 2 items ( " h and le money , " " manage money " ) misfit the combined physical domain . These items were deleted to create SIS , version 3.0 . ( 2 ) Overall , the items are well targeted to the sample . The physical and participation domains have a wide range of items that capture difficulties that most individuals with stroke experience in physical and role functions , while the memory , emotion , and communication domains include items that capture limitations in the most impaired patients . ( 3 ) The order of items from less to more difficult was clinical ly meaningful . ( 4 ) The individual physical domains differentiated at least 3 ( high , average , low ) levels of functioning and the composite physical domain differentiated more than 4 levels of functioning . However , because difficulties with communication , memory , and emotion were not as frequently reported and difficulties with h and function were more frequently reported , these domains only differentiated 2 ( high , low ) to 3 ( high , average , low ) strata of patients . Time from stroke onset to administration of the SIS had little effect on item functioning . CONCLUSION Rasch analysis further established the validity of the SIS . The domains are unidimensional , the items have an excellent range of difficulty , and the domain scores differentiated patients into multiple strata . The activities of daily living/instrumental activities of daily living , mobility , strength , composite physical , and participation domains have the most robust psychometric characteristics . The composite physical domain is most able to discriminate difficulty in function in individuals after stroke , while the communication , memory , and emotion domain items only capture limitations in function in the more impaired groups of patients OBJECTIVES To compare the psychometric properties of the Activities-specific Balance Confidence Scale ( ABC ) and the Survey of Activities and Fear of Falling in the Elderly ( SAFE ) . DESIGN Secondary analysis using baseline and 12-week data from a r and omized , controlled trial on fall prevention . SETTING Upper Midwest metropolitan area with assessment s conducted in participants ' homes . PARTICIPANTS Population -based sample of 272 noninstitutionalized female Medicare beneficiaries aged 70 and older at risk of falling . MEASUREMENTS Participants self-administered the  ABC , SAFE , Geriatric Depression Scale , and Medical Outcomes Study 36-item Short Form Survey .  During a home visit , a nurse practitioner administered the  Berg Balance Test and Timed Up and Go  , measured  gait speed  , and asked about  falls and chronic illnesses .  RESULTS Baseline internal consistency measured using Cronbach alpha was 0.95 for the ABC and 0.82 for the SAFE . Baseline concurrent validity between the ABC  and SAFE measured using a correlation coefficient was -0.65 ( P<.001 ) . ABC and SAFE scores were significantly correlated at baseline with physical performance tests and self-reported health status . The ABC had stronger baseline correlations than the SAFE with most measures . Neither instrument demonstrated responsiveness to change at 12 weeks . CONCLUSION The ABC and SAFE demonstrated strong internal-consistency reliability and validity when self-administered . The ABC had stronger associations with physical functioning and may be more appropriate for studies focused on improving physical function . Both instruments demonstrated ceiling effects , which may explain the lack of responsiveness to change in relatively nonfrail older women . Instruments sensitive to measuring lower levels of fear of falling are needed to capture the full range of this phenomenon in this population The purpose of this study was to investigate the psychometric properties of a Dutch translation of the Multidimensional Pain Inventory , MPI-DLV . Data was available on 733 chronic pain patients . There were three issues of special interest . The first one related to the comparability between the MPI-DLV and the American and German MPI versions with regard to the psychometric aspects . The second dealt with the construct validity of the  MPI-DLV scale ' general activity ' . It was predicted that patients with high scores on this scale would be in better physical condition , as measured on a working-to-tolerance bicycle ergometer test . In relation to the third issue , attention was given to the factor-invariance between fibromyalgia patients and back pain patients . From the results obtained it was concluded that ( 1 ) the factorial structure of the three MPI parts is replicated and the reliability estimates and validity indicators are similar to those from the American and German versions ; ( 2 ) patients with high scores on the ' general activity ' scale are in better physical condition and ( 3 ) MPI-DLVs of fibromyalgia and back pain patients do have similar factorial structures . Evidence was also obtained that the  MPI-DLV  is sensitive to treatment changes . Applications of the MPI-DLV are discussed & NA ; The aim of this study was to examine the impact of pain on quality of life and its components in a representative sample of 320 well people , and patients selected from all major categories of illness .  Quality of life was assessed using a new , multidimensional , multilingual , generic profile design ed for cross‐cultural use in health care , i.e. the WHOQOL . Within the WHOQOL , pain and discomfort is one of 29 areas or facets of quality of life , grouped into six domains . It was found that pain and discomfort made a significant impact on perceptions of general quality of life related to health . Furthermore , the presence of pain affected perceptions of five of the six domains of quality of life ; the domain of spirituality , religion and personal beliefs being the exception . When quality of life is assessed , negative feelings are most closely associated with reports of pain and discomfort than any other facet . But quality of life surrounding pain and discomfort is more fully explained by the inclusion of six additional facets ; the availability of social care , mobility , activities of daily living , positive mood and to a lesser extent , sleep and dependence on medication . Together , these seven facets represent criteria against which the success of pain treatments may be evaluated . As predicted , those who were pain‐free had significantly better quality of life than those in pain . A longer duration of pain is associated with increasingly poorer quality of life . Intense affective pain is particularly detrimental to a good quality of life . The psychometric properties of the pain and discomfort facet of the WHOQOL and WHOQOL‐100 were assessed . Internal consistency ( reliability ) , discriminant and criterion/concurrent validity were found to be good to excellent , justifying the use of this instrument with a range of chronic and acute pain patients
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 .