Psychometric Validation of the National Eye Institute Visual Function Questionnaire — 25 (NEI VFQ-25) French Version The impact of visual impairment and eye disease on vision-related quality of life in a Mexican-American population: proyecto VER. Evaluating the Quality of Randomized Controlled Trials that Examine the Efficacy of Natural Health Products: A Systematic Review of Critical Appraisal Instruments Validation study of WOMAC: a health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip or knee. Aqueous shunts with mitomycin C versus aqueous shunts alone for glaucoma. Quality of life in newly diagnosed glaucoma patients : The Collaborative Initial Glaucoma Treatment Study. Prevalence and causes of low vision and blindness in a Japanese adult population: the Tajimi Study. Postoperative Complications in the Ahmed Baerveldt Comparison Study During Five Years of Follow-up. Content and Criterion Validity of the Preliminary Core Dataset for Clinical Trials in Fibromyalgia Syndrome Development and evaluation of an instrument for the critical appraisal of randomized controlled trials of natural products Cause-specific prevalence of bilateral visual impairment in Victoria, Australia: the Visual Impairment Project. Content validity and satisfaction with a stroke caregiver intervention program. The Worst Itch Numeric Rating Scale for patients with moderate to severe plaque psoriasis or psoriatic arthritis. Evaluating clinical change and visual function concerns in drivers and nondrivers with glaucoma. Measuring quality of life in cosmetic surgery patients with a condition-specific instrument: the Derriford Scale. Evaluation of the foot and ankle outcome score in patients with osteoarthritis of the ankle. Comparison of tools for assessing the methodological quality of primary and secondary studies in health technology assessment reports in Germany Psychometric properties of the National Eye Institute Visual Function Questionnaire (NEI-VFQ). NEI-VFQ Field Test Investigators. Psychometric properties of the National Eye Institute-Refractive Error Quality of Life instrument. Development of a methodological PubMed search filter for finding studies on measurement properties of measurement instruments Endoscopic axillary exploration and sentinel lymphadenectomy Validity of the MACTAR questionnaire as a functional index in a rheumatoid arthritis clinical trial. The McMaster Toronto Arthritis. The Amblyopia and Strabismus Questionnaire: English translation, validation, and subscales.
Abstract Objective : Physicians need reliable , valid and sensitive question naires to assess QOL related to glaucoma or ocular hypertension . This article presents the psychometric properties of the French version of the National Eye Institute Visual Function Question naire — 25 ( NEI VFQ-25 ) . Methods : A mail survey was sent to 20 000 households . The survey identified 581 residents with glaucoma or ocular hypertension . Of these a r and om sample ( n = 204 ) took part in a telephone survey during which the NEI VFQ-25 was completed by eligible patients ( those taking at least one topical treatment for glaucoma or ocular hypertension on the day of the interview ) . Multi-trait analysis was performed to assess the construct validity of the question naire . Internal consistency reliability was assessed using Cronbach ’s α and the average inter-item correlation . Known groups validity was assessed by comparing patients grouped by duration of glaucoma , adjusted for age and gender . Results : One hundred and seventy-three patients participated in the survey . Analysis of convergent validity showed that all of the items in each scale correlated above 0.40 with their own scale except for the ‘ driving ’ scale . The success rate of the discriminant validity ranged from 57.1 % to 100 % except for the ‘ driving ’ scale , which was 7.1 % . Cronbach ’s α coefficients were all above 0.70 except the ‘ driving ’ score . Participants with glaucoma for less than 20 years consistently had better ‘ global ’ , ‘ near vision ’ , ‘ distant vision ’ , ‘ driving ’ , ’ social function ’ and ‘ peripheral vision ’ scores than those with disease of 20 + years duration , indicating better QOL in patients with a shorter disease duration . Conclusion : The NEI VFQ-25 is a vali date d instrument to measure vision-targeted QOL in French population s with glaucoma PURPOSE To describe the relationship of visual acuity impairment and eye disease on vision-related quality of life , as measured by the 25-item National Eye Institute Visual Function Question naire ( NEI-VFQ-25 ) , in a cross-sectional , population -based study of older Hispanic persons living in Arizona . METHODS A r and om sample of block groups with Hispanic residents in Nogales and Tucson , Arizona , were selected for study . Participants were interviewed at home with a question naire that included the NEI-VFQ-25 , an instrument measuring vision-related quality of life . Acuity was obtained with Early Treatment Diabetic Retinopathy Study ( ETDRS ) charts and st and ard protocol . Cataract was determined by clinical examination , diabetic retinopathy was diagnosed on stereo fundus photographs , and glaucoma was diagnosed on the basis of clinical examination and visual field results . Analyses were done to determine the degree of association between subscale scores and acuity in the better-seeing eye , monocular visual impairment , and specific eye diseases , with adjustment for acuity . RESULTS Of the 4774 participants in the study , 99.7 % had completed question naires that were not completed by proxy . Participants with visual impairment had associated decrements in scores on all subscales , with a decrease in presenting acuity associated with a worse score ( P < 0.05 ) , after adjustment for demographic variables . Monocular impairment was also associated with lower scores in several subscales . In those with cataract , low acuity explained most of the low scores , but those with glaucoma or diabetic retinopathy had low scores independent of acuity . CONCLUSIONS In this study of Mexican-American persons aged 40 or more , monocular impairment and better-eye acuity was associated with a decrease in most domains representing quality of life .  Subjects with uncorrected refractive error , cataract , diabetic retinopathy , and glaucoma had associated decrements in quality of life , many not explained by loss of acuity . Further work on the specific measures of vision associated with reported decreases in quality of life , such as visual field or contrast sensitivity , is warranted The purpose of this project was to conduct a systematic review to identify instruments design ed to evaluate the quality of r and omized controlled trials ( RCTs ) of natural health products ( NHPs ) . Instruments were examined for inclusion of items assessing methods , identity and content of the NHP , generalizability of results and instructions for use . Online data bases , websites , textbooks and reference lists were search ed to identify instruments . Relevance assessment and data extraction of articles were completed by two investigators and disagreements were settled by the third investigator . Data were analyzed using descriptive statistics . Of the 4442 citations identified , 29 were potentially relevant with 16 meeting the criteria for inclusion . None of the instruments stated they were vali date d ; content in the four areas of interest varied considerably . The most common items included r and omization sequence generation ( 100 % ) , blinding ( 100 % ) , allocation concealment ( 75 % ) and participant flow ( 75 % ) . Only nine of the NHP instruments included at least one item to appraise the specific content of the NHP . The CONSORT Statement for Herbal Interventions most closely addressed the four areas of interest ; however , this instrument was specific for herbs . There is a need for the development of a vali date d instrument for assessment of the quality of RCTs that would be useful for herbs as well as other NHPs Within the context of a double blind r and omized controlled parallel trial of 2 nonsteroidal antiinflammatory drugs , we vali date d WOMAC , a new multidimensional , self-administered health status instrument for patients with osteoarthritis of the hip or knee . The pain , stiffness and physical function subscales fulfil conventional criteria for face , content and construct validity , reliability , responsiveness and relative efficiency . WOMAC is a disease-specific purpose built high performance instrument for evaluative research in osteoarthritis clinical trials BACKGROUND Glaucoma affects more than 70 million people worldwide , with about 10 % being bilaterally blind , making it the leading cause of irreversible blindness globally . In patients with advanced glaucoma or those who have failed medical treatment without achieving adequate intraocular pressure ( IOP ) control , trabeculectomy ( glaucoma filtration surgery where an ostium is created into the anterior chamber from underneath a partial thickness scleral flap to allow for aqueous flow out of the anterior chamber intointo the subconjunctival space forming a filtering bleb ) and aqueous shunt surgery for more complex and refractory cases remain the mainstay therapies . Proliferation of fibrous tissue around an implanted aqueous shunt may block the diffusion of aqueous humour . Mitomycin C ( MMC ) is one of two commonly used adjunct antifibrotic agents used during aqueous shunt surgery to prevent proliferation of fibrous tissue . However , the effectiveness and safety of the use of intraoperative MMC during aqueous shunt surgery has not been established . OBJECTIVES To evaluate the effectiveness and safety of MMC versus no MMC used during aqueous shunt surgery for reducing IOP in primary and secondary glaucoma . SEARCH METHODS We search ed the Cochrane Central Register of Controlled Trials ( CENTRAL ) ( which contains the Cochrane Eyes and Vision Trials Register ) ( 2018 , Issue 2 ) ; Ovid MEDLINE ; Embase .com ; PubMed ; Latin American and Caribbean Health Sciences Literature Data base ( LILACS ) ; Clinical Trials.gov and the World Health Organization ( WHO ) International Clinical Trials Registry Platform ( ICTRP ) . We did not use any date or language restrictions in the electronic search for trials . We last search ed the electronic data bases on 13 February 2018 . SELECTION CRITERIA We included r and omized controlled trials ( RCTs ) in which one group of participants received MMC during aqueous shunt surgery and another group did not . We did not exclude studies based on outcomes . DATA COLLECTION AND ANALYSIS Two review authors independently review ed titles and abstract s from the literature search es . We obtained full-text reports of potentially relevant studies and assessed them for inclusion . Two review authors independently extracted data related to study characteristics , risk of bias , and outcomes . We used st and ard method ological procedures expected by Cochrane . MAIN RESULTS We included five RCTs , with a total of 333 eyes with glaucoma r and omized , and identified two ongoing trials . All included trials examined the effect of MMC versus no MMC  when used during aqueous shunt surgery for glaucoma . The trials included participants with different types of uncontrolled glaucoma . One study was conducted in China , one in Saudi Arabia , two in the USA , and one study was a multicenter study conducted in Brazil , Canada , Scotl and , and USA . We assessed all trials as having overall unclear risk of bias due to incomplete reporting of study methods and outcomes ; two of the five trials were reported only as conference abstract s . None of the included trials reported mean decrease from baseline in IOP ; however , all five trials reported mean IOP at 12 months post-surgery . At 12 months , the effect of MMC on mean IOP compared with no MMC was unclear based on a meta- analysis of trials ( mean difference -0.12 mmHg , 95 % CI -2.16 to 2.41 ; low-certainty evidence ) . Two trial did not report sufficient information to include in meta- analysis , but reported that mean IOP was lower in the MMC group compared with the no MMC group at 12 months . None of the included trials reported mean change from baseline in visual acuity ; however , one trial reported lower mean LogMAR values ( better vision ) in the MMC group than in the no MMC group at 12 months post-surgery . None of the included studies reported the proportion of participants with stable best-corrected visual acuity . Three trials reported that loss of vision was not significantly different between groups ( no data available for meta- analysis ) .None of the included studies reported the proportion of participants with a postoperative hypertensive phase , which is defined as IOP > 21 mmHg within 3 months after surgery . Two trials reported adverse events ( choroidal effusion , corneal edema , flat anterior chamber , and retinal detachment ) ; however , due to small numbers of events and sample sizes , no clear difference between MMC and placebo groups was observed . AUTHORS ' CONCLUSIONS We found insufficient evidence in this review to suggest MMC provides any postoperative benefit for glaucoma patients who undergo aqueous shunt surgery . Data across all five included trials were sparse and the reporting of study methods required to assess bias was inadequate . Future RCTs of this intervention should report methods in sufficient detail to permit assessment of potential bias and estimate target sample sizes based on clinical ly meaningful effect sizes OBJECTIVE The Collaborative Initial Glaucoma Treatment Study ( CIGTS ) was design ed to determine whether patients with newly diagnosed open-angle glaucoma are better treated initially by medicine or immediate filtering surgery . This paper describes the quality -of-life ( QOL ) measurement approach , instruments included , and the CIGTS participants ' QOL findings at the time of diagnosis . DESIGN Baseline results from a r and omized , controlled clinical trial . PARTICIPANTS Six hundred seven patients from 14 clinical centers were enrolled . INTERVENTION Patients r and omized to initial medication received a stepped medical regimen ( n = 307 ) . Those r and omized to initial surgery underwent a trabeculectomy ( n = 300 ) . The baseline interview was conducted before treatment initiation . All baseline and posttreatment  QOL assessment s were conducted by telephone from a central ized interviewing center . MAIN OUTCOME MEASURES The primary outcome measure described in this paper was QOL . The QOL instrument is multidimensional and incorporates both disease-specific and generic measures , including the Visual Activities Question naire , Sickness Impact Profile , and a Symptom and Health Problem CHECKLIST : RESULTS The correlations between QOL measures and clinical outcomes were in the expected direction , but relatively weak . At initial diagnosis , difficulty with bright lights and with light and dark adaptation were the most frequently reported symptoms related to visual function , whereas visual distortion was the most bothersome . Approximately half of the patients reported at least some worry or concern about the possibility of blindness . Within the Visual Activities Question naire , higher scores on the Peripheral Vision subscale were associated with more field loss ( P < 0.01 ) . In regression analyses controlling for sociodemographics and nonocular comorbidities , increased visual field loss was significantly associated with higher dysfunction among five disease-specific QOL measures ( P < 0.05 ) . CONCLUSIONS Newly diagnosed glaucoma patients reported experiencing some visual function symptoms at the time of diagnosis that would not be intuitively expected based on clinical testing . Some discussion about the association between clinical presentation and worry about blindness may reduce unnecessary concern . These results provide the basis for long-term comparisons of the QOL effects of initial medical and surgical treatment for open-angle glaucoma OBJECTIVE To determine the prevalence and causes of low vision and blindness in a Japanese adult population . DESIGN Population -based cross-sectional study . PARTICIPANTS R and omly selected residents ( n = 3870 ) of Tajimi City , Japan , who were 40 years of age or older . METHODS Of the 3021 study participants ( 78.1 % of 3870 eligible persons ) , 2977 ( 76.9 % ) underwent a complete ophthalmologic examination including measurement of the best-corrected visual acuity ( BCVA ) with full subjective refraction using a L and olt ring chart at 5 m. Age- and gender-specific prevalence rates of low vision and blindness were estimated and causes were identified . MAIN OUTCOME MEASURES Low vision and blindness were defined as BCVA in the better eye worse than 20/60 to a lower limit of 20/400 and worse than 20/400 , respectively ( World Health Organization [ WHO ] criteria ) and worse than 20/40 but better than 20/200 and 20/200 or worse , respectively ( United States criteria ) . RESULTS The overall prevalence of blindness according to the WHO or U.S. criteria was 0.14 % ( n = 4 ; 95 % confidence interval [ CI ] , 0.06 - 0.32 ) . The primary causes were optic atrophy , myopic macular degeneration , retinitis pigmentosa , and uveitis . The overall prevalence of low vision according to the WHO criteria was 0.39 % ( 95 % CI , 0.18%-0.60 % ) and according to the U.S. criteria was 0.98 % ( 95 % CI , 0.66%-1.30 % ) , which was significantly greater in women and in the older half of the participants than in the younger half ( P = 0.0079 and < 0.0001 , respectively ) . The leading causes of low vision in descending order were cataract followed by glaucoma , and those of monocular blindness were myopic macular degeneration , glaucoma , and trauma . CONCLUSIONS The prevalence of  low vision  and  blindness in Japanese adults was one of the lowest among those reported . The major causes of low vision were cataract and glaucoma , and the leading cause of monocular blindness was myopic macular degeneration PURPOSE To compare the late complications in the Ahmed Baerveldt Comparison Study during 5 years of follow-up . DESIGN Multicenter , prospect i ve r and omized clinical trial . METHODS setting : Sixteen international clinical centers . STUDY POPULATION Two hundred seventy-six subjects aged 18 - 85 years with previous intraocular surgery or refractory glaucoma with intraocular pressure of > 18 mm Hg . INTERVENTIONS Ahmed Glaucoma Valve FP7 or Baerveldt Glaucoma Implant BG 101 - 350 . MAIN OUTCOME MEASURES Late postoperative complications ( beyond 3 months ) , reoperations for complications , and decreased vision from complications . RESULTS Late complications developed in 56 subjects ( 46.8 ± 4.8 5-year cumulative % ± SE ) in the Ahmed Glaucoma Valve group and 67 ( 56.3 ± 4.7 5-year cumulative % ± SE ) in the Baerveldt Glaucoma Implant group ( P = .082 ) . The cumulative rates of serious complications were 15.9 % and 24.7 % in the Ahmed Glaucoma Valve and Baerveldt Glaucoma Implant groups , respectively ( P = .034 ) , although this was largely driven by subjects who had tube occlusions in the 2 groups ( 0.8 % in the Ahmed Glaucoma Valve group and 5.7 % in the Baerveldt Glaucoma Implant group , P = .037 ) . Both groups had a relatively high incidence of persistent diplopia ( 12 % ) and corneal edema ( 20 % ) , although half of the corneal edema cases were likely due to pre-existing causes other than the aqueous shunt . The incidence of tube erosion was 1 % and 3 % in the Ahmed Glaucoma Valve and Baerveldt Glaucoma Implant groups , respectively ( P = .04 ) . CONCLUSIONS Long-term rates of vision-threatening complications and complications result ing in reoperation were higher in the Baerveldt Glaucoma Implant than in the Ahmed Glaucoma Valve group over 5 years of follow-up Objective . Increasing research interest and emerging new therapies for treatment of fibromyalgia ( FM ) have led to a need to develop a consensus on a core set of outcome measures that should be assessed and reported in all clinical trials , to facilitate interpretation of the data and underst and ing of the disease . This aligns with the key objective of the Outcome Measures in Rheumatology ( OMERACT ) initiative to improve outcome measurement through a data driven , interactive consensus process . Methods . Through patient focus groups and Delphi processes , working groups at previous OMERACT meetings identified potential domains to be included in the core data set . A systematic review has shown that instruments measuring these domains are available and are at least moderately sensitive to change . Most instruments have been vali date d in multiple language s. This pooled analysis study aims to develop the core data set by analyzing data from 10 r and omized controlled trials ( RCT ) in FM . Results . Results from this study provide support for the inclusion of the following in the core data set : pain , tenderness , fatigue , sleep , patient global assessment , and multidimensional function/health related quality of life . Construct validity was demonstrated with outcome instruments showing convergent and divergent validity . Content and criterion validity were confirmed by multivariate analysis showing R square values between 0.4 and 0.6 . Low R square value is associated with studies in which one or more domains were not assessed . Conclusion . The core data set was supported by high consensus among attendees at OMERACT 9 . Establishing an international st and ard for RCT in FM should facilitate future metaanalyses and indirect comparisons Background The efficacy of natural products ( NPs ) is being evaluated using r and omized controlled trials ( RCTs ) with increasing frequency , yet a search of the literature did not identify a widely accepted critical appraisal instrument developed specifically for use with NPs . The purpose of this project was to develop and evaluate a critical appraisal instrument that is sufficiently rigorous to be used in evaluating RCTs of conventional medicines , and also has a section specific for use with single entity NPs , including herbs and natural source d chemicals . Methods Three phases of the project included : 1 ) using experts and a Delphi process to reach consensus on a list of items essential in describing the identity of an NP ; 2 ) compiling a list of non-NP items important for evaluating the quality of an RCT using systematic review methodology to identify published instruments and then compiling item categories that were part of a vali date d instrument and /or had empirical evidence to support their inclusion and 3 ) conducting a field test to compare the new instrument to a published instrument for usefulness in evaluating the quality of 3 RCTs of a NP and in applying results to practice . Results Two Delphi rounds result ed in a list of 15 items essential in describing NPs . Seventeen item categories fitting inclusion criteria were identified from published instruments for conventional medicines . The new assessment instrument was assembled based on content of the two lists and the addition of a Review er 's Conclusion section . The field test of the new instrument showed good criterion validity . Participants found it useful in translating evidence from RCTs to practice . Conclusion A new instrument for the critical appraisal of RCTs of NPs was developed and tested . The instrument is distinct from other available assessment instruments for RCTs of NPs in its systematic development and validation . The instrument is ready to be used by pharmacy students , health care practitioners and academics and will continue to be refined as required PURPOSE To study the cause-specific prevalence of eye diseases causing  bilateral visual impairment in Australian adults . DESIGN Two-site , population -based cross-sectional study . PARTICIPANTS Participants were aged 40 years and older and resident in their homes at the time of recruitment for the study . The study was conducted during 1992 through 1996 . METHODS The study uses a cluster stratified r and om sample of 4744 participants from two cohorts , urban , and rural Victoria . Participants completed a st and ardized interview and eye examination , including presenting and best-corrected visual acuity , visual fields , and dilated ocular examination . The major cause of vision loss was identified for all participants found to be visually impaired . Population -based prevalence estimates are weighted to reflect the age and gender distribution of the two cohorts in Victoria . MAIN OUTCOME MEASURES Visual impairment was defined by four levels of severity on the basis of best-corrected visual acuity or visual field : < 6/18 > or = 6/60 and /or < 20 degrees > or = 10 degrees radius field , moderate vision impairment ; severe vision impairment , < 6/60 > or = 3/60 and /or < 10 degrees > or = 5 degrees radius field ; and profound vision impairment < 3/60 and /or < 5 degrees radius field . In addition , less-than-legal driving vision , < 6/12 > or = 6/18 , and /or homonymous hemianopia were defined as mild vision impairment . In Australia , legal blindness includes severe and profound vision impairment . RESULTS The population -weighted prevalence of diseases causing less-than-legal driving or worse impairment in the better eye was 42.48/1000 ( 95 % confidence interval [ CI ] , 30.11 , 54.86 ) . Uncorrected refractive error was the most frequent cause of bilateral vision impairment , 24.68/1000 ( 95 % CI , 16.12 , 33.25 ) , followed by age-related macular degeneration ( AMD ) , 3.86/1000 ( 95 % CI , 2.17 , 5.55 ) ; other retinal diseases , 2.91/1000 ( 95 % CI , 0.74 , 5.08 ) ; other disorders , 2.80/1000 ( 95 % CI , 1.17 , 4.43 ) ; cataract , 2.57/1000 ( 95 % CI , 1.38 , 3.76 ) ; glaucoma , 2.32/1000 ( 95 % CI , 0.72 , 3.92 ) ; neuro-ophthalmic disorders , 1.80/1000 ( 95 % CI , 0 , 4.11 ) ; and diabetic retinopathy , 1.53/1000 ( 95 % CI , 0.71 , 2.36 ) . The prevalence of legal blindness was 5.30/1000 ( 95 % CI , 3.24 , 7.36 ) . Although not significantly different , the causes of legal blindness were uncorrected refractive errors , AMD , glaucoma , other retinal conditions , and other diseases . CONCLUSIONS Significant reduction of visual impairment may be attained with the application of current knowledge in refractive errors , diabetes mellitus , cataract , and glaucoma . Although easily preventable , uncorrected refractive error remains a major cause of vision impairment BACKGROUND AND PURPOSE Establishing evidence of content validity and satisfaction is an integral part of intervention research . The purpose of this article is to describe content validity and satisfaction relative to the Telephone Assessment and Skill-Building Kit ( TASK ) , an 8-week follow-up program based on individualized assessment of stroke caregiver needs . DESIGN AND METHODS The TASK intervention enables caregivers to develop skills based on assessment of their own needs . During the development of the TASK program , 10 experts rated the validity of the TASK intervention components for accuracy , feasibility , acceptability , and problem relevance . After incorporating feedback from the experts , a r and omized controlled clinical trial was instituted using a convenience sample of 40 stroke caregivers to determine satisfaction ( usefulness , ease of use , and acceptability ) with the TASK intervention ( n=21 ) compared with an attention control group ( n=19 ) . Data collection occurred between March 2005 and June 2006 . Data were analyzed using descriptive statistics , independent sample t tests , and content analysis . FINDINGS Expert ratings on a 1 to 5 scale , with 5 being strongly agree , provided evidence of content validity ( accuracy 4.71 , feasibility 4.46 , acceptability 4.40 , problem relevance 4.67 ) . Caregivers in the TASK group scored significantly higher than the attention control group on all satisfaction measures ( usefulness p=.02 ; ease of use p=.02 ; acceptability p=.05 ) . Qualitative comments from caregivers provided further evidence of satisfaction . CONCLUSIONS Evidence of content validity and user satisfaction for the TASK intervention relative to an attention control group was found . CLINICAL RELEVANCE The TASK program may be a viable telephone-based program that can be implemented by nurses to support family caregivers during the first few months after stroke survivors are discharged home Plaque psoriasis ( PP ) and psoriatic arthritis ( PsA ) are autoinflammatory chronic conditions associated with skin involvement . Pruritus , or itching , is a prevalent and bothersome symptom in patients with PP and is associated with reduced health-related quality of life . The Worst Itch Numeric Rating Scale ( WI-NRS ) has been developed as a simple , single item with which to assess the patient-reported severity of this symptom at its most intense during the previous 24-hour period . Qualitative research was undertaken to assess the content validity of the WI-NRS . Patients with moderate to severe PP and patients with PsA were recruited from clinical sites in the USA . The qualitative research entailed two-part interviews , which began with concept elicitation to gain underst and ing of patients ' experiences of itching , followed by cognitive debriefing of the WI-NRS to assess the instrument 's underst and ability , clarity , and degree of appropriateness from the patient 's perspective . Twelve patients with PP and 22 with PsA participated in the study . Patients reported that itching was an important and relevant symptom of their psoriatic disease . The WI-NRS was reported to be complete and easy to underst and ; the recall period was considered appropriate , the response scale was familiar , and , overall , the instrument was found to be appropriate for assessing itching severity . Patient responses support the content validity of the WI-NRS . The psychometric properties of the tool will be evaluated in future studies PURPOSE To compare drivers and nondrivers , and to describe the specific concerns of drivers , among individuals with glaucoma . METHODS Six hundred seven patients with newly diagnosed glaucoma treated at 14 clinical centers of the Collaborative Initial Glaucoma Treatment Study were r and omly assigned to initial medicine or surgery and were followed up every 6 months . Driving status (  drivers versus nondrivers ) and patient-reported visual function were determined by the Visual Activities Question naire and the National Eye Institute Visual Function Question naire . Clinical evaluation included visual field mean deviation ( MD ) and visual acuity . Statistical comparisons were made using t , chi(2 ) , and exact tests and regression and Rasch analyses . RESULTS Drivers were more likely than nondrivers to be male , white , married , employed , and more educated and to have higher incomes and fewer comorbidities . More than 50 % of drivers reported at least " some " difficulty performing tasks involving glare , whereas 22 % reported at least " some " difficulty with tasks requiring peripheral vision . At 54 months , drivers with moderate/severe bilateral visual field loss ( VFL ) reported greater difficulty with night driving and tasks involving visual search and visual processing speed than drivers with less bilateral VFL ( all P<0.05 ) . Although those who remained drivers over follow-up had better MD in both eyes than those who became nondrivers because of eyesight , a number of drivers had marked VFL . CONCLUSIONS Inquiring about specific difficulties with tasks related to glare , visual processing speed , visual search , and peripheral vision in driving , especially among patients with substantial bilateral visual field damage , will enable physicians to more effectively counsel patients regarding driving OBJECTIVE To assess the reliability , validity and sensitivity to change of the Derriford Scale , a quality of life instrument design ed to assess the distress and dysfunction experienced by people who are self-conscious about their physical appearance . SUBJECTS AND DESIGN Postal question naire survey of 656 cosmetic surgery patients recruited from new referral letters and plastic surgery waiting list reports . A total of 443 subjects completed and returned the question naire .  Of these respondents , 203 were sent a second question  naire to assess reproducibility , of whom 155 subjects responded . MAIN OUTCOME MEASURES Reliability was assessed in terms of internal consistency and reproducibility . Face , content and construct validity were also investigated . RESULTS The analyses led to mixed results . There was some evidence of internal consistency , but a number of items had low endorsement levels and there may be scope for reducing the overall size of the instrument . When assessed for reproducibility , the level of agreement between scores of individuals completing the question naire on two occasions was high , but an important systematic shift in responses was also detected . Correlations between the other health status measures and the Derriford Scale provided some evidence of construct validity . CONCLUSION In its present form the Derriford Scale has good descriptive value , but there are some measurement problems identified in this report that need to be addressed before the scale is taken up into general use The foot and ankle outcome score ( FAOS ) has been evaluated for many conditions of the foot and ankle . We evaluated its construct validity in 136 patients with osteoarthritis of the ankle , its content validity in 37 patients and its responsiveness in 39 . Data were collected prospect ively from the registry of patients at our institution . All FAOS subscales were rated relevant by patients . The Pain , Activities of Daily Living , and Quality of Life subscales showed good correlation with the Physical Component score of the Short-Form-12v2 . All subscales except Symptoms were responsive to change after surgery . We concluded that the FAOS is a weak instrument for evaluating osteoarthritis of the ankle . However , some of the FAOS subscales have relative strengths that allow for its limited use while we continue to seek other satisfactory outcome instruments Health care policy background Findings from scientific studies form the basis for evidence -based health policy decisions . Scientific background Quality assessment s to evaluate the credibility of study results are an essential part of health technology assessment reports and systematic review s. Quality assessment tools ( QAT ) for assessing the study quality examine to what extent study results are systematic ally distorted by confounding or bias ( internal validity ) . The tools can be divided into checklists , scales and component ratings . Research questions What QAT are available to assess the quality of interventional studies or studies in the field of health economics , how do they differ from each other and what conclusions can be drawn from these results for quality assessment s ? Methods A systematic search of relevant data bases from 1988 onwards is done , supplemented by screening of the references , of the HTA reports of the German Agency for Health Technology Assessment ( DAHTA ) and an internet search . The selection of relevant literature , the data extraction and the quality assessment are carried out by two independent review ers . The substantive elements of the QAT are extracted using a modified criteria list consisting of items and domains specific to r and omized trials , observational studies , diagnostic studies , systematic review s and health economic studies . Based on the number of covered items and domains , more and less comprehensive QAT are distinguished . In order to exchange experiences regarding problems in the practical application of tools , a workshop is hosted . Results A total of eight systematic method ological review s is identified as well as 147 QAT : 15 for systematic review s , 80 for r and omized trials , 30 for observational studies , 17 for diagnostic studies and 22 for health economic studies . The tools vary considerably with regard to the content , the performance and quality of operationalisation . Some tools do not only include the items of internal validity but also the items of quality of reporting and external validity . No tool covers all elements or domains . Design -specific generic tools are presented , which cover most of the content criteria . Discussion The evaluation of QAT by using content criteria is difficult , because there is no scientific consensus on the necessary elements of internal validity , and not all of the generally accepted elements are based on empirical evidence . Comparing QAT with regard to contents neglects the operationalisation of the respective parameters , for which the quality and precision are important for transparency , replicability , the correct assessment and interrater reliability . QAT , which mix items on the quality of reporting and internal validity , should be avoided . Conclusions There are different , design -specific tools available which can be preferred for quality assessment , because of its wider coverage of substantive elements of internal validity . To minimise the subjectivity of the assessment , tools with a detailed and precise operationalisation of the individual elements should be applied . For health economic studies , tools should be developed and complemented with instructions , which define the appropriateness of the criteria . Further research is needed to identify study characteristics that influence the internal validity of studies 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 OBJECTIVE To estimate the psychometric properties of a vision-targeted measure of health-related quality of life , the National Eye Institute-Refractive Error Quality of Life survey ( NEI-RQL ) , which includes 13 scales design ed to assess the impact of refractive error and its correction on day-to-day life . DESIGN Cross-sectional survey . PARTICIPANTS The NEI-RQL was self-administered by 667 myopes , 380 hyperopes , and 114 emmetropes recruited from the practice s of 6 medical centers . All participants had near and distance visual acuity of 20/32 or better in the worse eye while benefiting from their current method for correction of refractive error ( glasses , contact lens , refractive surgery ) .  METHODS Mean scores , st and ard deviations , internal consistency reliability , and test-retest intraclass correlations were estimated for the NEI-RQL scales . Item discrimination was assessed by item-scale correlations . Construct validity was evaluated by assessing the sensitivity of scale scores to type of refractive error , type of refractive error correction , and spherical equivalent . Construct validity of the NEI-RQL was compared to those of the Medical Outcomes Study 36-item short-form health survey ( SF-36 ) and the National Eye Institute Vision Functioning Question naire ( NEI VFQ-25 ) in a r and om sub sample of respondents . MAIN OUTCOME MEASURES The 13 NEI-RQL scales-clarity of vision , expectations , near vision , far vision , diurnal fluctuations , activity limitations , glare , symptoms , dependence on correction , worry , suboptimal correction , appearance , and satisfaction with correction . RESULTS Emmetropes tended to score significantly better on the NEI-RQL scales than myopes and hyperopes . The method of refractive error correction was also associated with NEI-RQL scores . In addition , the NEI-RQL multi-item scales accounted for 29 % of the variance in the NEI-RQL satisfaction with correction item beyond that explained by the SF-36 and the NEI VFQ-25 . CONCLUSION These results support the reliability and construct validity of the NEI-RQL . The instrument appears to be useful for comparisons of people with different types of correction for refractive error Objectives For the measurement of  patient-reported outcomes , such as ( health-related ) quality of life , often many measurement instruments exist that intend to measure the same construct . To facilitate instrument selection , our aim was to develop a highly sensitive search filter for finding studies on measurement properties of measurement instruments in PubMed and a more precise search filter that needs less abstract s to be screened , but at a higher risk of missing relevant studies . Methods A r and om sample of 10,000 PubMed records ( 01 - 01 - 1990 to 31 - 12 - 2006 ) was used as a gold st and ard . Studies on measurement properties were identified using an exclusion filter and h and search ing . Search terms were selected from the relevant records in the gold st and ard as well as from 100 systematic review s of measurement properties and combined based on sensitivity and precision . The performance of the filters was tested in the gold st and ard as well as in two validation sets , by calculating sensitivity , precision , specificity , and number needed to read . Results We identified 116 studies on measurement properties in the gold st and ard . The sensitive search filter was able to retrieve 113 of these 116 studies ( sensitivity 97.4 % , precision 4.4 % ) . The precise search filter had a sensitivity of 93.1 % and a precision of 9.4 % . Both filters performed very well in the validation sets . Conclusion The use of these search filters will contribute to evidence -based selection of measurement instruments in all medical fields Abstract Background : Minimally invasive approaches have changed the practice of surgery in several specialties . The purpose of this study was to develop a reproducible endoscopic technique for the evaluation of the axilla in breast cancer patients . Methods : A total of 23 patients with biopsy-proven breast carcinoma were enrolled . Patients were positioned in the supine position with the ipsilateral arm abducted at 90 ° . A 1-cm skin incision was made at the superior aspect of the axilla . Dissection was carried bluntly to the lateral border of the pectoralis major . A balloon distention device was inserted into the tract and distended under endoscopic vision to create a working space . Insufflation was initiated up to a pressure of 8 mmHg . A 30 ° laparoscope was introduced for visualization of axillary contents . One or two additional 5-mm cannulas were placed as needed under direct visualization . Manipulation of axillary contents was performed , and in 19 patients a sentinel node identification technique was applied . Results : In all patients , using insufflation and minimal instrument dissection , the axillary vein , long thoracic , and thoracodorsal nerves were found in their usual anatomical locations . Utilizing blunt and sharp dissection , the axilla was thoroughly inspected , and individual lymph nodes were easily identified and extracted . In 11 of 19 patients , a sentinel node or blue dye was identified using isosulfan blue . There was a procedure concordance of 84 % , and there were no complications . Conclusions : We describe a novel endoscopic technique for the evaluation of the axilla in breast cancer patients . This technique allows ( a ) creation of a minimally invasive working space within the axilla , ( b ) recognition of key axillary anatomic l and marks , and ( c ) instrument manipulation within the axilla to identify and extract lymph nodes , and apply the sentinel node technique . This is the first report of a minimally invasive approach to axillary exploration to employ sentinel lymph node mapping OBJECTIVES The McMaster Toronto Arthritis patient preference question naire ( MACTAR ) is a functional index that measures change in impaired activities selected by each patient in a baseline interview , and change in rheumatoid arthritis ( RA ) disease activity . In addition , it contains questions on the state of physical , social and emotional function and overall health , and their relation to RA . We evaluated MACTAR 's feasibility and validity ( content validity , construct validity , and responsiveness ) . METHODS A r and omized trial of combined treatment in 155 patients with early RA ; patients ' mean age at baseline was 50 years and median disease duration since diagnosis was 4 months . RESULTS Feasibility : MACTAR requires trained interviewers . In the trial , interviews took about 15 min . In longer term followup , activities selected at baseline may become less relevant as the pattern of disability changes . Followup from 153 patients ( 99 % ) was available . At least 5 impaired activities were identified and ranked by 147 patients ( 95 % ) ; interviewers could follow 99 % of these . The scoring system proved complex and required amendments . Content validity : Although its main focus is physical function , the MACTAR also contains generic questions ; 75 % of the patients named at least one impaired activity from the category " mobility . " Only 48 % were covered by Health Assessment Question naire ( HAQ ) items . Construct validity : MACTAR scores correlate highly with other functional indices and with measures of disease activity . Responsiveness : At 16 weeks the st and ardized response mean for the total MACTAR score in the combined-treatment group was excellent , at 2.2 . Items that directly address change were even more responsive . CONCLUSION The MACTAR interview is a valid and highly responsive instrument to assess change in functional ability of patients with early RA with active disease . It provides insight into problems -- mainly of physical function -- that really matter to patients . For st and ard clinical trials and clinical care , feasibility of the MACTAR is limited and the simpler HAQ remains the instrument of choice PURPOSE To establish the English- language version of the  Amblyopia and Strabismus Question naire ( ASQE ) . DESIGN Prospect i ve cohort study . METHODS A structured translation process was followed to generate the ASQE , a 26-item instrument ( originally in Dutch ) containing five subscales for fear of losing the better eye , distance estimation , visual disorientation , double vision , and social contact and appearance . The ASQE was administered to 150 adults in a private practice setting . All had strabismus with or without amblyopia and visual acuity of 20/50 or better in at least one eye . Subjects also completed a brief disability question naire , and they were further characterized by levels of unilateral vision loss , diplopia , and asthenopia . RESULTS ASQE scores were highly correlated with the disability question naire outcomes ( r = -.76 , P < .0001 ) . Internal consistency reliability ( Cronbach alpha ) of the subscales ranged from 0.80 to 0.92 . Strong correlations were found between clinical characteristics and the ASQE ( total score and subscale scores ) . CONCLUSIONS The ASQE showed good psychometric properties that are in line with those of the original instrument . This , combined with strong correlations between ASQE scores and clinical characterization of the participants , establishes the ASQE as a useful tool for use in population s with strabismus and /or amblyopia
The National Eye Institute Visual Function Question naire-25 , Impact of Vision Impairment and Treatment Satisfaction Survey-Intraocular Pressure had the highest number of positive ratings in the content validity assessment .
Conclusion This study provides a descriptive catalogue of vision-specific PRO instruments , to inform the choice of an appropriate measure of patient-reported outcomes in a glaucoma context
Purpose To identify  vision Patient-Reported Outcomes instruments relevant to glaucoma and assess their content validity .