Are current foot- and ankle outcome measures appropriate for the evaluation of treatment for osteoarthritis of the ankle?: Evaluation of ceiling effects in foot- and ankle outcome measures. A systematic review of outcome tools used to measure lower leg conditions. The foot function index is more sensitive to change than the Leeds Foot Impact Scale for evaluating rheumatoid arthritis patients after forefoot or hindfoot reconstruction Validation of the Foot and Ankle Outcome Score in Adult Acquired Flatfoot Deformity Evaluation of the foot and ankle outcome score in patients with osteoarthritis of the ankle. Failed validation of a clinical decision rule for the use of radiography in acute ankle injury. Reappraisal of use of X-rays in childhood ankle and midfoot injuries Impact of comorbidities on the measurement of health in patients with ankle osteoarthritis. Assessment tools for identifying functional limitations associated with functional ankle instability. An Evaluation of Two Foot-Specific, Health-Related Quality-of-Life Measuring Instruments Sensitivity of the Ottawa rules. The PROMIS of Better Outcome Assessment: Responsiveness, Floor and Ceiling Effects, and Internet Administration Responsiveness and Validity of the SF-36, Ankle Osteoarthritis Scale, AOFAS Ankle Hindfoot Score, and Foot Function Index in End Stage Ankle Arthritis The effect of triage-applied Ottawa Ankle Rules on the length of stay in a Canadian urgent care department: a randomized controlled trial. Structural measures as predictors of injury basketball players. Evaluation of the Dutch version of the Foot and Ankle Outcome Score (FAOS): responsiveness and Minimally Important Change A study to develop clinical decision rules for the use of radiography in acute ankle injuries.
BACKGROUND Many PROMs used for evaluation of ankle  osteoarthritis  are not vali date d for this purpose . We hypothesize that frequently used PROMs have an early ceiling or floor effect . METHODS We prospect ively collected data from patients with ankle osteoarthritis between 2011 and 2013 . At baseline visit patients completed the Foot and Ankle Outcome Score , the Ankle Osteoarthritis Score , the American Orthopaedic Foot and Ankle Society scale , a visual analogue scale for pain and quality of life . Outcomes were analyzed for floor or ceiling effects . RESULTS 197 patients were included in the study . A floor effect was present for the AOFAS and VAS for pain in all groups . Floor and ceiling effect are absent for the FAOS outcome measure for all groups . CONCLUSIONS Physicians should be aware of floor or ceiling effects when evaluating treatment using patient reported outcome measures . The FAOS outcome measure lacks early ceiling or floor effects BACKGROUND CONTEXT A variety of self-report and physical performance-based outcome measures are commonly used to assess progress and recovery in the lower leg , ankle , and foot . A requisite attribute of any outcome measure is its ability to detect change in a condition , a construct known as " responsiveness " . There is a lack of consistency in how responsiveness is defined in all outcome measures . PURPOSE The purpose of this study was to review the currently used recovery outcome measures for lower leg , ankle and foot conditions in order to determine and report recommended responsiveness values . METHODS A systematic literature search that included electronic search es of PubMed , CINAHL and SportD iscus as well extensive cross-referencing was performed in January , 2013 . Studies were included if each involved : 1 ) a prospect i ve , longitudinal study of any design ; 2 ) any condition associated with the lower leg , ankle or foot ; 3 ) a measure of responsiveness ; and 4 ) was an acceptable type of outcome measure ( eg . self-report , physical performance , or clinician report ) . The quality of the included articles was assessed by two independent authors using the responsiveness sub-component of the Consensus-based St and ards for the selection of health Measurement Instruments ( COSMIN ) . RESULTS Sixteen different studies met the inclusion criteria for this systematic review . The most commonly used outcome measures were the Foot and Ankle Ability Measure and the Lower Extremity Functional Scale . Responsiveness was calculated in a variety of methods including effect size , st and ardized response mean , minimal clinical ly important difference/ importance , minimal detectable change , and minimal important change . CONCLUSION Based on the findings of this systematic review there is a lack of consistency for reporting responsiveness among recovery measures used in the lower leg , ankle or foot studies . It is possible that the variability of conditions that involve the lower leg , ankle and foot contribute to the discrepancies found in reporting responsiveness values . Further research must be conducted in order to st and ardize reporting measures for responsiveness . LEVEL OF EVIDENCE 2a Purpose This study examines the responsiveness of the Foot Functional Index ( FFI ) and Leeds Foot Impact Scale for Rheumatoid Arthritis ( LFIS-RA ) in rheumatoid arthritis ( RA ) patients receiving a forefoot or hindfoot reconstruction .  Methods This was a prospect i ve cohort study including 30 rheumatoid arthritis patients with severe rheumatoid foot deformities in need for surgical correction .  Responsiveness was measured using distribution-based methods ( st and ardized effect size , st and ardized response mean and Guyatt responsiveness ratio ) and anchor-based methods ( receiver operating characteristics curves and correlation analyses ) by making use of an anchor question . To examine the depth of the question naires we measured the floor and ceiling effects . Results The study population consisted of three males and 27 females , with a mean age of 62 years . The mean follow-up time was 38 months . Twenty-two feet received a forefoot reconstruction and eight feet a triple arthrodesis . For the FFI the SES was −0.80 , SRM was −0.85 and the GRR was −1.25 . For the LFIS-RA the SES was 0.58 , SRM was 0.58 and the GRR was 0.88 . The AUC was 0.741 and 0.645 for FFI and LFIS , respectively . Contrary to the LFIS-RA , the FFI showed a significant correlation between change score and the anchor question . Both question naires did not show a significant floor or ceiling effect . Conclusion The FFI showed a large responsiveness and the LFIS- RA showed moderate responsiveness in rheumatoid arthritis patients receiving forefoot or hindfoot surgery , without floor or ceiling effects in both question naires Introduction : The American Orthopaedic Foot and Ankle Society ( AOFAS ) Ankle-Hindfoot Score has been under recent scrutiny . The Foot and Ankle Outcome Score ( FAOS ) is an alternative subjective survey , assessing outcomes in 5 subscales . It is vali date d for lateral ankle instability and hallux valgus patients . The aim of our study was to vali date the FAOS for assessing outcomes in flexible adult acquired flatfoot deformity ( AAFD ) . Methods : Patients from the authors ’ institution diagnosed with flexible AAFD from 2006 to 2011 were eligible for the study . In all , 126 patients who completed the FAOS and the Short-Form 12 ( SF-12 ) on the same visit were included in the construct validity component . Correlation was deemed moderate if the Spearman ’s correlation coefficient was .4 to .7 . Content validity was assessed in 63 patients by a question naire that asked patients to rate the relevance of each FAOS question , with a score of 2 or greater considered acceptable . Reliability was measured using intraclass correlation coefficients ( ICCs ) in 41 patients who completed a second FAOS survey . In 49 patients , preoperative and postoperative FAOS scores were compared to determine responsiveness . Results : All of the FAOS subscales demonstrated moderate correlation with 2 physical health related SF-12 domains . Mental health related domains showed poor correlation . Content validity was high for the Quality of Life ( QoL ; mean 2.26 ) and Sports/Recreation subscales ( mean 2.12 ) . All subscales exhibited very good test – retest reliability , with ICCs of .7 and above . Symptoms , QoL , pain , and daily activities ( ADLs ) were responsive to change in postoperative patients ( P < .05 ) . Conclusion : This study has vali date d the FAOS for AAFD with acceptable construct and content validity , reliability , and responsiveness . Given its previous validation for patients with ankle instability and hallux valgus , the additional findings in this study support its use as an alternative to less reliable outcome surveys . Level of Evidence : Level II , prospect i ve comparative study 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 AIM To vali date the Ottawa clinical decision rule for the use of radiography in acute ankle injuries . METHOD A prospect i ve , multicentre trial of 350 adult patients presenting with acute ankle injuries consisting of correlation of the features of the Ottawa clinical decision rule with the results of x-rays . RESULTS There were 75 fractures in 350 patients , five of which would have been missed by the clinical decision rule . The sensitivity of the rule was 93 % with a specificity of 11 % . The positive predictive value was 22 % , the false negative rate 14 % . Fractures that would have been missed by the clinical decision rule included one unstable fracture of the ankle , one fracture of the talus , one calcaneal fracture and one fracture each of the cuboid and navicular . CONCLUSION The Ottawa clinical decision rule for the use of radiography in acute ankle injuries is unacceptable for application in emergency departments in New Zeal and due to a high false negative rate Abstract . Objectives : To determine whether the Ottawa ankle rules ( OAR ) can be applied in children and what the potential reduction in the use of X-ray studies might be . Methods : Prospect i ve , observational study of children attending emergency department with blunt ankle and midfoot injuries .  X-ray studies were obtained after recording of the physical assessment . A single investigator who was blinded to the emergency physician 's interpretations and to the radiologist 's interpretations of the studies then applied the OAR to each patient . Sensitivity , specificity , and positive and negative predictive values of the OAR were calculated with 95 % confidence intervals . Results : The OAR were 100 % sensitive ( 95 % CI=81–100 % ) and 30 % specific ( 95%CI=19–43 % ) . Positive and negative predictive values were 28 % ( 95%CI=17–41 % ) and 100 % ( 95 % CI=82–100 % ) respectively . The number of X-ray studies ordered would have been reduced by 24 % if the OAR had been applied . Conclusions : The Ottawa ankle rules are very sensitive and can be applied in children , result ing in a reduction in the use of X-rays studies BACKGROUND Investigators seeking to underst and the impact of musculoskeletal disorders commonly use vali date d outcome instruments to assess the effect of diseases on physical function and quality of life . However , the influence of concomitant systemic or musculoskeletal comorbidities on these scores has not been widely considered in orthopaedic research . The purpose of this study was to determine how morbidity unrelated to the ankle influences the perception of physical function and pain by patients with ankle osteoarthritis . METHODS  Short Form-36 ( SF-36 ) Physical Component Summary ( PCS ) and Mental Component Summary ( MCS ) scores , Ankle Osteoarthritis Scale ( AOS ) pain scale scores ,  demographic data  , and systemic and musculoskeletal comorbidities were determined prospect ively for 195 patients with ankle osteoarthritis and ninety-five age and gender-matched controls . The effect of systemic and musculoskeletal comorbidities on each of the scores was determined . RESULTS On the average , patients with ankle osteoarthritis had a relatively normal MCS score ( 47 + /- 13 points ) and a markedly diminished PCS score ( 32 + /- 8 points ) . Both of these scores averaged 50 + /- 9 points in the control group . The AOS pain score averaged 61 + /- 23 points in the group with ankle osteoarthritis , whereas it averaged 10 + /- 15 points in the control group . We found the perception of ankle pain by patients with ankle osteoarthritis to be significantly and linearly associated with the number of other musculoskeletal problems ( not related to the foot or ankle ) . CONCLUSIONS The degree of physical impairment associated with ankle osteoarthritis , as measured with the SF-36 , is equivalent to that reported to be associated with severely disabling medical problems including end-stage kidney disease and congestive heart failure . The perception of ankle health status as measured with a vali date d , patient-oriented , anatomically specific instrument is influenced by the patients ' perception of their overall musculoskeletal comorbidity status . The authors of clinical studies using these instruments should adjust for concomitant musculoskeletal disease CONTEXT Assessment tools should identify functional limitations associated with functional ankle instability ( FAI ) by discriminating unstable from stable ankles . OBJECTIVE To identify assessment tools that discriminated FAI from stable ankles and determine the most accurate assessment tool for discriminating between FAI and stable ankles . DESIGN Case-control study . SETTING Research laboratory . PATIENTS OR OTHER PARTICIPANTS Fifteen individuals with FAI and 15 healthy individuals ; participants with unilateral FAI reported " giving-way " sensations and ankle sprains , whereas healthy participants did not . INTERVENTION(S ) Participants answered 12 questions on the Ankle Joint Functional Assessment Tool ( AJFAT ) .  They also performed a single-leg jump l and ing , which required them to jump to half their maximum jump height , l and on a single leg , and stabilize quickly on a force plate . MAIN OUTCOME MEASURE(S ) Receiver operating characteristic curves determined cutoff scores for discriminating between ankle groups for AJFAT total score and result ant vector ( RV ) time to stabilization . Accuracy values for discriminating between groups were determined by calculating the area under the receiver operating characteristic curves . RESULTS The cutoff score for discriminating between FAI and stable ankles was > or = 26 ( sensitivity = 1 , specificity = 1 ) and > or = 1.58 seconds ( sensitivity = 0.67 , specificity = 0.73 ) for the AJFAT total score and RV time to stabilization , respectively . The area under the curve for the AJFAT was 1.0 ( asymptotic significance < .05 ) , whereas the RV time to stabilization had an area under the curve of 0.72 ( asymptotic significance < .05 ) . CONCLUSIONS The AJFAT was an excellent assessment tool for discriminating between ankle groups , whereas RV time to stabilization was a fair assessment tool . Although both assessment s discriminated between ankle groups , the AJFAT more accurately discriminated between groups than the RV time to stabilization did . Future research ers should confirm these findings using a prospect i ve research design In the past decade ,  health-related quality -of-life ( HRQoL ) assessment  has become an important tool to measure change as a result of treatment in clinical trials . The aim of this project was to compare and contrast two foot-specific HRQoL question naires : the Foot Function Index ( FFI ) and the Foot Health Status Question naire ( FHSQ ) . To assist in this process , a quasi-experimental trial was performed to evaluate the effectiveness of foot orthoses in improving HRQoL  in people suffering from plantar fasciitis . The results from this study found that the FFI is generally less responsive to change , particularly in the domain of Activity Limitation . Nevertheless , significant improvements were found for two out of the three domains ( Pain and Disability , but not Activity Limitation ) for the FFI , as well as the overall score of FFI . In contrast , all four domains ( Pain , Function , Footwear and General Foot Health ) of the FHSQ showed significant improvement . Our experience with the question naires also revealed that certain questions in the Activity Limitation domain of the FFI can lead to inconsistent scoring , thus casting doubts over the suitability of this domain for use with patients with plantar fasciitis . Therefore , the FHSQ has several advantages when evaluating  HRQoL in patients being treated with foot orthoses for plantar fasciitis , and should be viewed as the preferred question naire STUDY OBJECTIVE To vali date criteria predicting  ankle and mid-foot fractures  with 100 % sensitivity . DESIGN Prospect i ve validation study SETTING A 929-bed community teaching hospital with an annual census of 76,488 ED visits . PARTICIPANTS Convenience sample of patients older than 18 years with acute ankle or midfoot injury . INTERVENTIONS Radiography was performed in each patient received after pertinent history and physical examination findings were recorded . RESULTS Five hundred seventy radiographs were obtained in 484 patients . Four hundred twenty-one were of the ankle , and 149 were of the foot . There were 93 ankle fractures and 29 midfoot fractures , giving a fracture yield of 22.1 % for ankle films and 19.5 % for foot films . Decision rules had sensitivity of 94.6 % and specificity of 15.5 % for ankle fractures and sensitivity of 93.1 % and specificity of 11.5 % for midfoot fractures . Prospect i ve criteria failed to predict fracture in five of the ankle group and two of the midfoot group . Physicians predicting fracture solely on the basis of clinical suspicion had a sensitivity of 69 % in ankle injuries and 76 % in midfoot injuries . CONCLUSION We were unable to vali date with 100 % sensitivity the Ottawa rules predicting ankle and midfoot fractures . However , the Ottawa rules were more sensitive than clinical suspicion alone Objective . Use of item response theory ( IRT ) and , subsequently , computerized adaptive testing ( CAT ) , under the umbrella of the NIH-PROMIS initiative ( National Institutes of Health – Patient-Reported Outcomes Measurement Information System ) , to bring strong new assets to the development of more sensitive , more widely applicable , and more efficiently administered patient-reported outcome ( PRO ) instruments . We present data on current progress in 3 crucial areas : floor and ceiling effects , responsiveness to change , and interactive computer-based administration over the Internet . Methods . We examined nearly 1000 patients with rheumatoid arthritis and related diseases in a series of studies including a one-year longitudinal examination of detection of change ; compared responsiveness of the Legacy SF-36 and HAQ-DI instruments with IRT-based instruments ; performed a r and omized head-to-head trial of 4 modes of item administration ; and simulated the effect of lack of floor and ceiling items upon statistical power and sample sizes . Results . IRT-based PROMIS instruments are more sensitive to change , result ing in the potential to reduce sample size requirements substantially by up to a factor of 4 . The modes of administration tested did not differ from each other in any instance by more than one-tenth of a st and ard deviation . Floor and ceiling effects greatly reduce the number of available subjects , particularly at the ceiling . Conclusion . Failure to adequately address floor and ceiling effects , which determine the range of an instrument , can result in suboptimal assessment of many patients . Improved items , improved instruments , and computer-based administration improve PRO assessment and represent a fundamental advance in clinical outcomes research Background : We examined four commonly used scores , the SF-36 , the  Ankle Osteoarthritis Scale ( AOS )  , the  American Orthopaedic Foot and Ankle Society ( AOFAS ) Ankle Hindfoot Score  , and the  Foot Function Index ( FFI )  to determine their responsiveness and validity . Methods : Patients with end stage ankle arthritis were recruited into a prospect i ve multicenter cohort study and baseline and one year outcome scores were compared . The St and ardized Response Mean and Effect Size for the AOS , AOFAS , and FFI were calculated and the three region- or disease-specific scores were compared with the SF-36 to determine their criterion validity . Results : All four scores showed acceptable responsiveness , and when using the vali date d SF-36 as the st and ard the three region or disease specific scores all showed similar criterion validity . Conclusion : All four scores are responsive and can be considered for use in this population . The objective component of the AOFAS Ankle Hindfoot Score may make it harder to perform than the other three scores which have subjective components only , and as yet its objective component has not been shown to demonstrate reliability . We recommend use of a purely subjective score such as the Ankle Osteoarthritis Scale or Foot Function Index as the region- or disease-specific score of choice in this population . As the SF-36 shows acceptable responsiveness , using it alone could also be considered . Level of Evidence : II , Prospect i ve Comparative OBJECTIVES To determine whether triage nurses ordering ankle or foot radiographs according to the Ottawa Ankle Rules ( OAR ) before physician evaluation decreases the length of stay for patients visiting an urgent care department . METHODS From July to September 2004 , a r and omized controlled trial of consecutive adult patients with ankle or foot twisting injuries who arrived at an urgent care department was conducted . Patients were included if their age was 18 years or older and their injury had occurred within seven days . They were excluded if there were neurovascular deficits , limb deformities , open fractures , or nonisolated ankle or foot injuries . Patients were r and omly allocated to a roentgenogram-ordering clinical pathway ( intervention ) or to st and ard departmental care ( control ) . Those assigned to the intervention group had triage nurses applying the OAR , and those with positive OAR were sent for roentgenograms before physician evaluation . Physicians were blinded to negative OAR nurse assessment s. Investigators were blinded to group allocation . The primary outcome was the total mean length of stay ( TLOS ) . The secondary outcomes were patient satisfaction ( five-point ordinal scale ) and the proportion willing to return to the site for future care . Two-independent sample t-test was used to analyze the TLOS . The Kruskal-Wallis test was used to analyze satisfaction ratings differences between groups . Fisher 's exact test was used to analyze the willing-to-return outcome . This study had 80 % power to detect an effect size of 25 minutes . RESULTS Two hundred thirty-two patients were eligible ; 130 patients gave consent and were enrolled . Three patients were then excluded , three were lost to follow-up , and one left without being seen . The intervention and control groups had mean TLOS of 73.0 minutes and 79.7 minutes , respectively . There was a statistically nonsignificant time difference of -6.7 minutes ( 95 % CI = -20.9 to 7.4 ) between groups . There were no differences in patient satisfaction ratings ( p-value = 0.343 ) or WOR ( 3.8 % ; 95 % CI = -3.3 % to 11.0 % ) . CONCLUSIONS The use of OAR and the ordering of roentgenograms by triage nurses before physician evaluation for twisting ankle or foot injuries does not decrease the length of stay in an urgent care department The purpose of this study was to investigate the relationship between structure and injury in basketball players , with the goal of developing equations to predict injury . We examined 45 subjects who were participating in a community center basketball league . Each subject was measured prior to the season for bilateral weight , quadricep girth , calf girth , Q-angle of the knee , dorsiflexion of the ankle , forefoot varus , rearfoot valgus , and true and apparent leg length . All lower extremity injuries causing a game to be missed were recorded during the 16-game season . Average values for bilateral weight , quadricep girth , Q-angle , rearfoot valgus , and leg length measures for the injured players were all larger than the average for the non-injured players by at least one st and ard deviation . A logistic regression equation using three of the variables correctly predicted the injury status of 91 % of the players . The three-variable equation was then used prospect ively to predict injury status for members of a small college basketball team . Only one player missed a game due to injury , and the equation identified that player as the most likely to be injured . This study demonstrates a strong relationship between structural measures and lower extremity injury in basketball players Purpose The aim of this study was to evaluate the responsiveness of the Foot and Ankle Outcome Score ( FAOS ) and provide data on the Minimally Important Change ( MIC ) in patients 1 year after hindfoot and ankle surgery . Methods Prospect i ve pre-operative and 1 year post-operative FAOS scores were collected from 145 patients . A patient ’s global assessment and a longitudinal derived Function Change Score were used as external anchors . To assess responsiveness , effect sizes ( ES ) and St and ardized Response Means ( SRM ) were calculated and hypotheses on their magnitudes were formulated . Additional ROC curve analysis was performed , and the Area Under the Curve ( AUC ) was calculated as a measure of responsiveness . MIC values were estimated using two different methods : ( 1 ) the mean change method and ( 2 ) the optimal cut-off point of the ROC curve . Results Responsiveness was supported by confirmation of 84 % of the hypothesized ES and SRM and almost all AUCs exceeding 0.70 . MIC values ranged from 7 ( symptoms ) to 38 ( sport ) points . They varied between calculation methods and were negatively associated with baseline values . A considerable amount of MIC values did not exceed the smallest detectable change limit , indicating that the FAOS is more suitable at group level than for longitudinally following individual patients . Conclusions The FAOS demonstrated good responsiveness in patients 1 year after hindfoot and ankle surgery . Due to their wide variation , MIC estimates derived in this study should be interpreted with caution . However , these estimates can be of value to facilitate sample size calculation in future studies .Level of evidence Diagnostic study , Level STUDY OBJECTIVE To develop decision rules that will predict fractures in patients with ankle injuries , thereby assisting clinicians in being more selective in their use of radiography . DESIGN Prospect i ve survey of emergency department patients over a five-month period . SETTING Two university hospital EDs . PARTICIPANTS One hundred fifty-five adults in a pilot stage and 750 in the main study ; all presented with acute blunt ankle injuries . INTERVENTIONS Thirty-two st and ardized clinical variables were assessed and recorded on data sheets by staff emergency physicians before radiography . MEASUREMENTS Variables were assessed for reliability by the kappa coefficient and for association with significant fracture on both ankle and foot radiographic series by univariate analysis . The data then were analyzed by logistic regression and recursive partitioning techniques to develop decision rules for predicting fractures in each radiographic series . MAIN RESULTS All 70 significant malleolar fractures found in the 689 ankle radiographic series performed were identified among people who had pain near the malleoli and were age 55 years or more , had localized bone tenderness of the posterior edge or tip of either malleolus , or were unable to bear weight both immediately after the injury and in the ED . This rule was 100 % sensitive and 40.1 % specific for detecting malleolar fractures and would allow a reduction of 36.0 % of ankle radiographic series ordered . Similarly , all 32 significant midfoot fractures on the 230 foot radiographic series performed were found among patients with  pain in the midfoot and bone tenderness  at the base of the fifth metatarsal , the cuboid , or the navicular . CONCLUSION Highly sensitive decision rules have been developed and will now be vali date d ; these may permit clinicians to confidently reduce the number of radiographs ordered in patients with ankle injuries
While there are many different scoring systems available for foot and ankle specialists to use to assess or demonstrate the effectiveness of treatments , the AOFAS , while it is an unvali date d scoring system , is the most commonly used scoring system in this review .
This review presents data about commonly used patient reported outcomes systems in foot and ankle surgery .
The goal of this systematic review is to determine the most commonly used outcome measurement tools used by foot and ankle specialists and determine their limitations , such as whether they are vali date d , have floor/ceiling effects , and so on .