The patient-oriented eczema measure: development and initial validation of a new tool for measuring atopic eczema severity from the patients' perspective. Validation of the Eczema Area and Severity Index for atopic dermatitis in a cohort of 1550 patients from the pimecrolimus cream 1% randomized controlled clinical trials programme Validation of the Fatigue Severity Scale in chronic hepatitis C Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Asthma symptom utility index: reliability, validity, responsiveness, and the minimal important difference in adult asthmatic patients. Patient Health Questionnaire Anxiety and Depression Scale: Initial Validation in Three Clinical Trials The Reliability and Validity of a Modified Total Neuropathy Score-Reduced and Neuropathic Pain Severity Items When Used to Measure Chemotherapy-Induced Peripheral Neuropathy in Patients Receiving Taxanes and Platinums Psychometric assessment of three newly developed implementation outcome measures The stroke impact scale version 2.0. Evaluation of reliability, validity, and sensitivity to change. Psychometric evaluation of the FACT Colorectal Cancer Symptom Index (FCSI-9): reliability, validity, responsiveness, and clinical meaningfulness. Assessing adherence to the evidence base in the management of poststroke dysphagia A Modified National Institutes of Health Stroke Scale for Use in Stroke Clinical Trials: Preliminary Reliability and Validity Psychometric properties of the National Eye Institute Visual Function Questionnaire (NEI-VFQ). NEI-VFQ Field Test Investigators. 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 Psychometric properties of a generic health measure in patients with neck pain Analysis of outcome measures for persons with patellofemoral pain: which are reliable and valid? Physical Impairment Index: Reliability, Validity, and Responsiveness in Patients with Acute Low Back Pain Validation of the Psoriasis Symptom Inventory (PSI), a patient-reported outcome measure to assess psoriasis symptom severity Development and validation of the Liverpool infant bronchiolitis severity score: a research protocol. The Brown Assessment of Beliefs Scale: reliability and validity. Development and validation of a short questionnaire in community acquired pneumonia The effectiveness of surgery for stress incontinence in women: a systematic review. Use of Condition-Specific Patient-Reported Outcome Measures in Clinical Trials among Patients with Wrist Osteoarthritis: A Systematic Review
OBJECTIVE To develop a simple , valid , repeatable , and readily underst and able patient-oriented assessment measure for monitoring disease activity in children and adults with atopic eczema . DESIGN Qualitative semistructured patient interviews identified a list of symptoms of atopic eczema . These symptoms were quantitatively analyzed in a larger patient population to identify which symptoms were important to patients and amenable to monitoring as part of a scoring system . SETTING The outpatient Department of Dermatology at the Queen 's Medical Centre , University Hospital , Nottingham , Engl and , and 5 local general practice s. PATIENTS Four hundred thirty-five patients with atopic eczema . RESULTS Seven symptoms were incorporated into the final patient-oriented eczema measure using a simple 5-point scale of frequency of occurrence during the previous week , with a maximum total score of 28 . Validity testing against the Dermatology Life Quality Index , Children 's Dermatology Life Quality Index , and patients ' global severity assessment s showed good correlation ( r = 0.78 , r = 0.73 , and r = 0.81 , respectively ; P<.001 ) . Internal consistency was high ( Cronbach alpha = 0.88 ) , and test-retest reliability was good , with 95 % of scores falling within 2.6 points on repeat testing ( mean score difference , 0.04 ; SD , 1.32 ) . Individual variables in the measure demonstrated sensitivity to change during a 4-week in-clinic period and an 18-week r and omized controlled clinical trial . CONCLUSION The patient-oriented eczema measure is a practical self-assessed measurement tool for monitoring aspects of atopic eczema that are important to patients in routine clinical practice or in the clinical trial setting Objective To vali date the Eczema Area and Severity Index ( EASI ) by assessing its internal consistency , reliability and sensitivity to change and by correlating it to other efficacy parameters . Background Fatigue is a common symptom of chronic hepatitis C virus ( cHCV ) infection and a common side effect of interferon-based treatment for cHCV . This study provides confirmatory evidence of the reliability and validity of the Fatigue Severity Scale ( FSS ) to document fatigue in cHCV research and identifies values that indicate clinical ly important differences in FSS to aid in interpreting fatigue in cHCV clinical trials . Methods The study used data from two double-blind , r and omized , placebo-controlled , Phase IIb trials evaluating the efficacy and safety of simeprevir plus peginterferon-α/ribavirin  in treatment-naïve ( PILLAR , n = 386 ) and treatment-experienced patients ( ASPIRE , n = 462 ) with cHCV infection . Patients completed the FSS and EuroQoL 5 dimension question naire ( EQ-5D ) at baseline and at regular intervals throughout both trials . Reliability was assessed using Cronbach ’s coefficient α at Week 24 ( internal consistency reliability ) and intraclass correlation ( ICC ) between FSS at Weeks 12 and 24 in stable patients ( < 0.5 g/dL hemoglobin [ Hb ] change between Weeks 12/24 ) . Correlation with the EQ-5D visual analog scale ( VAS ) and “ Usual Activity ” domain score was used to assess concurrent validity . Clinical validity was evaluated using a case-control method to link spontaneously reported fatigue and anemia adverse events ( AEs ) during the study to FSS scores . Results FSS total scores demonstrated good reliability ( Cronbach ’s α : 0.95 , 0.96 ; ICC : 0.74 , 0.86 for PILLAR and ASPIRE , respectively ) and concurrent validity ( correlation with EQ-5D VAS : -0.63 , -0.66 ) with a monotonic relationship between the EQ-5D “ Usual Activities ” item response and FSS . Clinical validity was confirmed by a significant difference between cases and controls for fatigue AEs ( p < 0.05 ) ; however , anemia defined by AE or Hb abnormalities was only weakly related to FSS score . Analyses indicate that a change of 0.33–0.82 in mean FSS scores represents a meaningful improvement in fatigue , and a one-point change is a conservative indicator of an important change in individual FSS scores . Conclusion A difference of ≥0.7 in mean FSS scores can be considered a clinical ly important difference within groups over time or between groups . A one-point change or less in individual FSS scores indicates a clinical ly relevant change in fatigue Background : Insomnia is a prevalent health complaint that is often difficult to evaluate reliably . There is an important need for brief and valid assessment tools to assist practitioners in the clinical evaluation of insomnia complaints . Objective : This paper reports on the clinical validation of the  Insomnia Severity Index ( ISI )  as a brief screening measure of insomnia and as an outcome measure in treatment research . The psychometric properties ( internal consistency , concurrent validity , factor structure ) of the ISI were evaluated in two sample s of insomnia patients . Methods : The first study examined the internal consistency and concurrent validity of the ISI  in 145 patients evaluated for insomnia at a sleep disorders clinic . Data from the ISI were compared to those of a sleep diary measure . In the second study , the concurrent validity of the  ISI  was evaluated in a sample of 78 older patients who participated in a r and omized-controlled trial of behavioral and pharmacological therapies for insomnia . Change scores on the  ISI  over time were compared with those obtained from sleep diaries and polysomnography .  Comparisons were also made between ISI scores obtained from patients , significant others , and clinicians . Results : The results of Study 1 showed that the  ISI  has adequate internal consistency and is a reliable self-report measure to evaluate perceived sleep difficulties . The results from Study 2 also indicated that the ISI is a valid and sensitive measure to detect changes in perceived sleep difficulties with treatment . In addition , there is a close convergence between scores obtained from the ISI patient 's version and those from the clinician 's and significant other 's versions . Conclusions : The present findings indicate that the ISI is a reliable and valid instrument to quantify perceived insomnia severity . The ISI is likely to be a clinical ly useful tool as a screening device or as an outcome measure in insomnia treatment research BACKGROUND The evaluation of asthma symptoms is a core outcome measure in asthma clinical research . The Asthma Symptom Utility Index ( ASUI ) was developed to assess the frequency and severity of asthma symptoms . The psychometric properties of the ASUI are not well characterized , and a minimal important difference ( MID ) is not established . OBJECTIVES We assessed the reliability , validity , and responsiveness to change of the ASUI in a population of adult asthmatic patients . We also sought to determine the MID for the ASUI . METHODS Adult asthmatic patients ( n = 1648 ) from 2 previously completed multicenter r and omized trials were included .  Demographic information , spirometric results , ASUI scores , and other asthma question naire scores  were obtained at baseline and during follow-up visits . Participants also kept a daily asthma diary . RESULTS The internal consistency reliability of the ASUI was 0.74 ( Cronbach α ) . Test-retest reliability was 0.76 ( intraclass correlation ) . Construct validity was demonstrated by significant correlations between ASUI scores and Asthma Control Question naire scores ( Spearman correlation r = -0.79 ; 95 % CI , -0.85 to -0.75 ; P < .001 ) and Mini Asthma Quality of Life Question naire scores ( r = 0.59 ; 95 % CI , 0.51 - 0.61 ; P < .001 ) . Responsiveness to change was demonstrated , with significant differences between mean changes in ASUI scores across groups of participants differing by 10 % in percent predicted FEV(1 ) ( P < .001 ) and by 0.5 points in Asthma Control Question naire scores ( P < .001 ) . Anchor-based and statistical methods support an MID for the ASUI of 0.09 points . CONCLUSIONS The ASUI is reliable , valid , and responsive to changes in asthma control over time . The MID of the ASUI ( range of scores , 0 - 1 ) is 0.09 Objective We examine the reliability and validity of the Patient Health Question naire Anxiety and Depression Scale (PHQ-ADS)—which combines the nine-item Patient Health Question naire depression scale and seven-item Generalized Anxiety Disorder scale — as a composite measure of depression and anxiety . Methods Baseline data from 896 patients enrolled in two primary -care based trials of chronic pain and one oncology- practice –based trial of depression and pain were analyzed . The internal reliability , st and ard error of measurement , and convergent , construct , and factor structure validity , as well as sensitivity to change of the PHQ-ADS were examined . Results The PHQ-ADS demonstrated high internal reliability ( Cronbach & agr ; values of .8 to .9 ) in all three trials . PHQ-ADS scores can range from 0 to 48 ( with higher scores indicating more severe depression/anxiety ) , and the estimated st and ard error of measurement was approximately 3 to 4 points . The PHQ-ADS showed strong convergent ( most correlations , 0.7–0.8 range ) and construct ( most correlations , 0.4–0.6 range ) validity when examining its association with other mental health , quality of life , and disability measures . PHQ-ADS cutpoints of 10 , 20 , and 30 indicated mild , moderate , and severe levels of depression/anxiety , respectively . Bifactor analysis showed sufficient unidimensionality of the PHQ-ADS score . PHQ-ADS change scores at 3 months differentiated ( p < .0001 ) between individuals classified as worse , stable , or improved by a reference measure , providing preliminary evidence for sensitivity to change . Conclusions The PHQ-ADS may be a reliable and valid composite measure of depression and anxiety which , if vali date d in other population s , could be useful as a single measure for jointly assessing two of the most common psychological conditions in clinical practice and research . Trial Registration : Clinical trials.gov Identifier : NCT00926588 ( SCOPE ) ; NCT00386243 ( ESCAPE ) ; NCT00313573 ( INCPAD ) Background : Assessment of chemotherapy-induced peripheral neuropathy signs and symptoms has been hampered because of the lack of simple , reliable , and valid measures . Objective : The study objective was to examine the internal consistency and interrater reliability as well as the structural validity of a 5-component total neuropathy score-reduced ( TNSr ) variant and a chemotherapy-induced neuropathy-specific Neuropathic Pain Scale . Methods : One hundred seventeen out patients receiving taxanes or platinums  were assessed by a consistent nurse practitioner using the 2 instruments . Ten subjects participated in interrater reliability testing . Results : Mean scores and SDs for individual items were low . The strength item was deleted because of low interitem correlations and a floor effect . The reflex item was deleted because of low interitem correlations and its negative influence on Cronbach & agr;. Pin sensibility was deleted because of low factor loadings . The TNSr-short form and the chemotherapy-induced neuropathy-specific Neuropathic Pain Scale formed 2 distinct factors , providing evidence of structural validity . Cronbach & agr ; 's for the 2 instruments were .80 and .96 , respectively . The TNSr interrater reliability results suggested acceptable rater concordance , but minor revisions could further improve scoring precision . Conclusion : Clinimetric evidence supports the use of 2 new instruments when monitoring taxane- and platinum-related neuropathy and pain . Further instrument modifications are recommended , followed by additional testing in diverse population s. Implication s for Practice : With these new instruments , nurses can more easily incorporate prospect i ve neuropathy assessment into daily clinical practice . The outcome will be improved symptom awareness by oncology clinicians and patients , leading to fewer chemotherapy-induced peripheral neuropathy-related devastating effects on functionality and quality of life Background Implementation outcome measures are essential for monitoring and evaluating the success of implementation efforts . Yet , currently available measures lack conceptual clarity and have largely unknown reliability and validity . This study developed and psychometrically assessed three new measures : the Acceptability of Intervention Measure ( AIM ) , Intervention Appropriateness Measure ( IAM ) , and Feasibility of Intervention Measure ( FIM ) . Methods Thirty-six implementation scientists and 27 mental health professionals assigned 31 items to the constructs and rated their confidence in their assignments . The Wilcoxon one- sample signed rank test was used to assess substantive and discriminant content validity . Exploratory and confirmatory factor analysis ( EFA and CFA ) and Cronbach alphas were used to assess the validity of the conceptual model . Three hundred twenty-six mental health counselors read one of six r and omly assigned  vignettes depicting a therapist contemplating adopting an evidence -based practice ( EBP ) . Participants used 15 items to rate the therapist ’s perceptions of the acceptability , appropriateness , and feasibility of adopting the EBP . CFA and Cronbach alphas were used to refine the scales , assess structural validity , and assess reliability . Analysis of variance ( ANOVA ) was used to assess known-groups validity . Finally , half of the counselors were r and omly assigned to receive the same vignette and the other half the opposite vignette ; and all were asked to re-rate acceptability , appropriateness , and feasibility . Pearson correlation coefficients were used to assess test-retest reliability and linear regression to assess sensitivity to change . Results All but five items exhibited substantive and discriminant content validity . A trimmed CFA with five items per construct exhibited acceptable model fit ( CFI = 0.98 , RMSEA = 0.08 ) and high factor loadings ( 0.79 to 0.94 ) . The alphas for 5-item scales were between 0.87 and 0.89 . Scale refinement based on measure-specific CFAs and Cronbach alphas using vignette data produced 4-item scales ( α ’s from 0.85 to 0.91 ) . A three-factor CFA exhibited acceptable fit ( CFI = 0.96 , RMSEA = 0.08 ) and high factor loadings ( 0.75 to 0.89 ) , indicating structural validity . ANOVA showed significant main effects , indicating known-groups validity . Test-retest reliability coefficients ranged from 0.73 to 0.88 . Regression analysis indicated each measure was sensitive to change in both directions . Conclusions The AIM , IAM , and FIM demonstrate promising psychometric properties . Predictive validity assessment is planned 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 BACKGROUND Patient-reported outcomes ( PROs ) are essential for evaluating treatment effects on health-related quality of life and symptoms from the patient 's perspective . This study sought to evaluate the psychometric properties of the nine-item Functional Assessment of Cancer Therapy/National Comprehensive Cancer Network Colorectal Cancer Symptom Index ( FCSI-9 ) in a metastatic colorectal cancer ( mCRC ) population . METHODS The FCSI-9 and EQ-5D were administered every 2 - 4 weeks to mCRC subjects in a phase III clinical trial . Three hundred ninety-one mCRC subjects completed the question naires at baseline and at least one follow-up assessment . Internal consistency reliability , test-retest reliability , construct validity , known groups validity , responsiveness , and the minimum important difference ( MID ) of the FCSI-9 were evaluated . RESULTS The internal consistency and test-retest reliability of the FCSI-9 were acceptable ( 0.81 and 0.76 , respectively ) . Construct validity was supported based on moderate correlations with the EQ-5D . Known groups validity was evaluated by examining the FCSI-9 scores of subjects categorized by their Eastern Cooperative Oncology Group performance status ( PS ) score . Subjects with better PS scores reported significantly higher FCSI-9 scores than those with lower PS scores at both baseline and week 8 . Responsiveness , as measured by Guyatt 's statistic , was 0.77 from baseline to week 8 and 0.60 from week 4 to week 12 . Considering all data together , the MID of the FCSI-9 is estimated to be in the range of 1.5 - 3.0 points . CONCLUSION Results provide preliminary evidence of the reliability , validity , and responsiveness of the FCSI-9 Objective : To evaluate the reliability and responsiveness to change of an audit tool to assess adherence to evidence of effectiveness in the  speech and language therapy ( SLT ) management of poststroke dysphagia . Design : The tool was used to review SLT practice as part of a r and omized study of different education strategies . Medical records were audited before and after delivery of the trial intervention . Setting : Seventeen SLT departments in the north-west of Engl and participated in the study . Subjects : The assessment tool was used to assess the medical records of 753 patients before and 717 patients after delivery of the trial intervention across the 17 departments . A target of 10 records per department per month was sought , using systematic sampling with a r and om start . Analysis : Inter- and intra-rater reliability were explored , together with the tool 's internal consistency and responsiveness to change . Results : The assessment tool had high face validity , although internal consistency was low ( r a=0.37 ) . Composite scores on the tool were however responsive to differences between SLT departments . Both inter- and intra-rater reliability ranged from ‘ substantial ’ to ‘ near perfect ’ across all items . Conclusions : The audit tool has high face validity and measurement reliability . The use of a composite adherence score should , however , proceed with caution as internal consistency is low Background and Purpose — The National Institutes of Health Stroke Scale ( NIHSS ) is accepted widely for measuring acute stroke deficits in clinical trials , but it contains items that exhibit poor reliability or do not contribute meaningful information . To improve the scale for use in clinical research , we used formal clinimetric analyses to derive a modified version , the mNIHSS . We then sought to demonstrate the validity and reliability of the new mNIHSS . Methods — The mNIHSS was derived from our prior clinimetric studies of the NIHSS by deleting poorly reproducible or redundant items ( level of consciousness , face weakness , ataxia , dysarthria ) and collapsing the sensory item into 2 responses . Reliability of the mNIHSS was assessed with the certification data originally collected to assess the reliability of investigators in the National Institute of Neurological Disorders and Stroke ( NINDS ) rtPA ( recombinant tissue plasminogen activator ) Stroke Trial . Validity of the mNIHSS was assessed with the outcome results of the NINDS rtPA Stroke Trial . Results — Reliability was improved with the mNIHSS : the number of scale items with poor & kgr ; coefficients on either of the certification tapes decreased from 8 ( 20 % ) to 3 ( 14 % ) with the mNIHSS . With the use of factor analysis , the structure underlying the mNIHSS was found identical to the original scale . On serial use of the scale , goodness of fit coefficients were higher with the mNIHSS . With data from part I of the trial data , the proportion of patients who improved ≥4 points within 24 hours after treatment was statistically significantly increased by tPA ( odds ratio , 1.3 ; 95 % confidence limits , 1.0 , 1.8;P = 0.05 ) . Likewise , the odds ratio for complete/nearly complete resolution of stroke symptoms 3 months after treatment was 1.7 ( 95 % confidence limits , 1.2 , 2.6 ) with the mNIHSS . Other outcomes showed the same agreement when the mNIHSS was compared with the original scale . The mNIHSS showed good responsiveness , ie , was useful in differentiating patients likely to hemorrhage or have a good outcome after stroke . Conclusions — The mNIHSS appears to be identical clinimetrically to the original NIHSS when the same data are used for validation and reliability . Power appears to be greater with the mNIHSS with the use of 24-hour end points , suggesting the need for fewer patients in trials design ed to detect treatment effects comparable to rtPA . The mNIHSS contains fewer items and might be simpler to use in clinical research trials . Prospect i ve analysis of reliability and validity , with the use of an independently collected cohort , must be obtained before the mNIHSS is used in a research setting OBJECTIVE To test the reliability and validity of the 51-item Field Test Version of the National Eye Institute Visual Function Question naire ( NEI-VFQ ) across 5 common chronic eye conditions . DESIGN Prospect i ve observational cohort study of persons with 1 of 5 chronic eye diseases who were scheduled for nonurgent visits in ophthalmology practice s or had low vision from any cause , and a reference sample of persons without eye disease . SETTING Six university-based ophthalmology practice s and the National Eye Institute Clinical Center , Bethesda , Md. PATIENTS Eligible participants had to have 1 of the following eye conditions : age-related cataracts , age-related macular degeneration , diabetic retinopathy , primary open-angle glaucoma , cytomegalovirus retinitis , or low vision from any cause . Each of the 7 sites also enrolled persons in a reference sample . Reference sample participants had no evidence of underlying eye disease but were scheduled for either screening eye examinations or correction of refractive error . All eligible persons had to be aged 21 years or older , English speaking , and cognitively able to give informed consent and participate in a health status interview . MEASUREMENTS AND MAIN RESULTS To provide the data needed to assess the reliability and validity of the 51-item NEI-VFQ  , all subjects completed an interview that consisted of the 51-item NEI-VFQ , the Medical Outcomes Study 36-Item Short-Form Health Survey , and at least 1 measure of vision-targeted functional status . Estimates of internal consistency and test-retest reproducibility indicate that the 51-item NEI-VFQ is reliable . Tests of association with other scales and clinical variables support the construct validity of the survey . CONCLUSIONS In this cross-sectional study , the 51-item NEI-VFQ seems to be reliable and valid and should be a useful tool for group-level comparisons of vision-targeted , health-related quality of life in clinical research . Additionally , the psychometric properties of the NEI-VFQ were not influenced by the type or severity of the underlying eye disease , suggesting that the measure will provide reproducible and valid data when used across multiple eye conditions 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 examine the reliability , validity and responsiveness of the generic Current Perceived Health 42 ( CPH42 ) Profile in Chinese patients with neck pain in Hong Kong . Design : A prospect i ve observational study . Setting : Physiotherapy outpatient departments . Subjects : Two sample s with 472 consecutive adult patients with neck pain from seven physiotherapy outpatient departments in Hong Kong . Methods : Subjects were requested to complete the CPH42 Profile , and their pain intensity was measured using the 11-point numerical rating scale ( NRS ) . They were observed and measured at the beginning of physiotherapy , at seven days , at week 3 and at week 6 after treatment began . Results : The CPH42 Profile had very good test – retest reliability and internal consistency ( intraclass correlation coefficient 0.91 , Cronbach 's alpha 0.90 ) . Validity was confirmed by a moderate correlation with the NRS at the beginning of treatment and week 6 ( rank correlation 0.41–0.53 ) . Moreover , a significant difference in scores was found between those who had sought medical consultation and /or had taken medication because of neck pain than those who did not . The responsiveness measured from the beginning of treatment to week 3 and week 6 ( st and ard response means of 0.33 and 0.36 ) was comparable to the respective changes in pain intensity . Conclusion : The CPH42 Profile has been shown to demonstrate good reliability and validity , and it is sensitive to changes in severity over time . It is suitable for use as an outcome measure for evaluation of patients with neck pain OBJECTIVE To examine the test-retest reliability , validity , and responsiveness of several outcome measures in the treatment of patellofemoral pain . DESIGN Evaluation of the clinimetric properties of individual outcome measures for patellofemoral pain treatment , using data collected from a previously published r and omized controlled trial ( RCT ) . SETTING General community and private practice . PARTICIPANTS The data from 71 persons enrolled in an RCT of a conservative intervention for patellofemoral pain were used to evaluate the measures ' validity and responsiveness . A subset of this cohort ( n=20 ) was used to assess reliability . INTERVENTIONS Not applicable . MAIN OUTCOME MEASURES Three  10-cm visual analog scales ( VASs ) for usual pain ( VAS-U ) , worst pain ( VAS-W ) , and pain on 6 aggravating activities ( walking , running , squatting , sitting , ascending and descending stairs ) ( VAS-activity ) ; the Functional Index Question naire ( FIQ ) ; the Anterior Knee Pain Scale ( AKPS ) ; and the global rating of change . RESULTS The test-retest reliability ranged from poor ( intraclass correlation coefficient [ICC]=.49 ) to good ( ICC=.83 ) , and the measures correlated moderately with each other ( r range,.56-.72 ) . Median change scores differed significantly between improved and unimproved persons for all measures . The effect sizes for VAS-U ( .79 ) , VAS-W ( .88 ) , and the AKPS ( .98 ) were large , indicating greater responsiveness than the FIQ ( .37 ) and VAS-activity ( .66 ) . Similarly , the AKPS and VAS-W were the most efficient measures for detecting a treatment effect when compared with a reference measure ( VAS-U , which was assigned a value of 1 ) . The minimal difference that patients or clinicians consider clinical ly important for the AKPS is 10 ( out of 100 ) points and for the VAS it is 2 cm ( out of 10 cm ) . CONCLUSIONS The AKPS and VAS for usual or worst pain are reliable , valid , and responsive and are therefore recommended for future clinical trials or clinical practice in assessing treatment outcome in persons with patellofemoral pain 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 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 AIM To develop and vali date a  bronchiolitis severity scoring instrument  for use by nurses and other healthcare professions . BACKGROUND Bronchiolitis is a viral lower respiratory tract infection of infancy . In industrialized countries , admission rates have increased over the last decade with up to 3 % of all infants born being admitted to hospital . A small number of these hospitalized infants will require admission to critical care for either invasive or non-invasive ventilation . During the seasonal epidemic , the number of unplanned admissions to critical care with bronchiolitis substantially increases . DESIGN We will use a mixed methods study design . METHODS We will use scale development and psychometric methods to develop a scoring instrument and to test the instrument for content , construct and criterion validity and reliability in several different clinical locations . This study protocol has been review ed and approved by the NHS National Research Ethics Service , January 2011 . DISCUSSION There is an urgent need to develop a valid and reliable severity scoring instrument sensitive to clinical changes in the infant , to facilitate clinical decision-making and help st and ardize patient care . Furthermore , a valid and reliable scoring instrument could also be used as a proxy patient-reported outcome measure to evaluate the efficacy of clinical interventions in r and omized controlled trials OBJECTIVE The authors developed and evaluated the reliability and validity of the Brown Assessment of Beliefs Scale , a clinician-administered seven-item scale design ed to assess delusions across a wide range of psychiatric disorders . METHOD The authors developed the scale after review ing the literature on the assessment of delusions . Four raters administered the scale to 20 patients with obsessive-compulsive disorder ( OCD ) , 20 patients with body dysmorphic disorder , and 10 patients with mood disorder with psychotic features .  Audiotaped interviews of scale administration conducted by one rater were independently scored by the other raters to evaluate interrater reliability . The scale was administered to 27 patients twice to determine test-retest reliability . Other insight instruments as well as scales that assess symptom severity were administered to assess convergent and discriminant validity . Sensitivity to change was assessed in a multicenter treatment study of sertraline for OCD . RESULTS Interrater and test-retest reliability for the total score and individual item scores was excellent , with a high degree of internal consistency . One factor was obtained that accounted for 56 % of the variance . Scores on the Brown Assessment of Beliefs Scale were not correlated with symptom severity but were correlated with other measures of insight . The scale was sensitive to change in insight in OCD but was not identical to improvement in severity . CONCLUSIONS The Brown Assessment of Beliefs Scale is a reliable and valid instrument for assessing delusionality in a number of psychiatric disorders . This scale may help clarify whether delusional and nondelusional variants of disorders constitute the same disorder as well as whether delusionality affects treatment outcome and prognosis Background : A short but sensitive question naire evaluating changes in respiratory symptoms and well being during the treatment of community acquired pneumonia ( CAP ) is needed . We have developed a measurement and evaluated its psychometric properties in 67 patients admitted with CAP . Methods : The patients were asked to indicate the presence and severity of dyspnoea , coughing , coughing up sputum , coughing up sputum with ease , the colour of the sputum , fatigue , fitness , and their state of health . The item fatigue showed substantial overlap with fitness and was therefore excluded . The response of the patients to the remaining eight items was used to calculate a CAP score . Results : The percentage of missing data ( 0.2–1.7 % ) , floor and ceiling effects ( 0.2/5.5 % ) , internal consistency ( Cronbach α = 0.87 ) , and the intraclass correlation coefficient for test-retest reproducibility ( 0.83 ) met predefined criteria , indicating good acceptability and reliability . Face and clinical validity were satisfactory . Effect sizes under treatment were large , indicating high responsiveness . Conclusion : The newly developed CAP score is a simple , reliable , valid , and highly responsive instrument . This makes it scientifically sound and clinical ly relevant for measuring outcome when evaluating treatment strategies in CAP OBJECTIVE To determine the method ological quality of studies evaluating surgery for stress incontinence , the effectiveness of different procedures and the frequency of complications associated with each procedure . MATERIAL S AND METHODS Eleven r and omized controlled trials , 20 non-r and omized trials/ prospect i ve cohort studies and 45 retrospective cohort studies were review ed systematic ally . RESULTS The method ological quality of the 31 prospect i ve studies was generally poor . The considerable variation in inclusion criteria , surgical management and assessment of outcome precluded any statistical meta- analysis . Evidence as to the effectiveness of surgery for stress incontinence is weak ; therefore , any conclusions are speculative . It appears that colposuspension may be more effective and the effect more long-lasting than that following anterior colporrhaphy and needle suspension . There is little information on the value of sling procedures . Comparisons of different ways of performing each procedure show no significant differences in outcome but this may reflect the method ological weaknesses of the studies . Valid and reliable data on the frequency of complications following surgery are lacking so the safety of the procedures is unclear . Repeat operations to correct stress incontinence are less successful than first procedures but this finding may be subject to confounding . CONCLUSIONS There is an urgent need for some large , rigorous , prospect i ve studies of high quality . Until such studies have been completed , recommendations as to the best clinical practice can not be based on scientific evidence . Studies need to define cases according to widely accepted criteria , including st and ard measures of the severity of stress incontinence , and surgical terminology for the procedures performed needs to be st and ardized and outcomes need to be clearly defined , valid and reliable , not confined to short-term assessment and include patients ' views along with the surgeon 's assessment Background . This paper aim ed to identify condition-specific patient-reported outcome measures used in clinical trials among people with wrist osteoarthritis and summarise empirical peer- review ed evidence supporting their reliability , validity , and responsiveness to change . Methods . A systematic review of r and omised controlled trials among people with wrist osteoarthritis was undertaken . Studies reporting reliability , validity , or responsiveness were identified using a systematic reverse citation trail audit procedure . Psychometric properties of the instruments were examined against predefined criteria and summarised . Results . Thirteen clinical trials met inclusion criteria . The most common patient-reported outcome was the disabilities of the arm , shoulder , and h and question naire ( DASH ) . The DASH , the  Michigan H and Outcomes Question naire ( MHQ ) , the  Patient Evaluation Measure ( PEM ) , and the  Patient-Reported Wrist Evaluation ( PRWE ) had evidence supporting their reliability , validity , and responsiveness . A post-hoc review of excluded studies revealed the AUSCAN Osteoarthritis H and Index as another suitable instrument that had favourable reliability , validity , and responsiveness . Conclusions . The DASH , MHQ , and AUSCAN Osteoarthritis H and Index instruments were supported by the most favourable empirical evidence for validity , reliability , and responsiveness . The PEM and PRWE also had favourable empirical evidence reported for these elements . Further psychometric testing of these instruments among people with wrist osteoarthritis is warranted
CLINICAL IMPLICATION S Only SCORAD , EASI , and POEM currently perform adequately .
BACKGROUND Valid and reliable outcome measurements are a prerequisite for evidence -based practice .
The comparative validity and reliability of outcome measurements for assessing atopic eczema ( AE ) severity is unclear .
OBJECTIVE We sought to assess the validity , reliability , sensitivity to change , and ease of use of outcome measurements for AE .
We also sought to give recommendations on which outcomes to use in clinical research and for clinical monitoring .